UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
☒
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2021
or
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission File Number: 001-38822
KALEIDO BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
Delaware
47-3048279
(State or other jurisdiction of
incorporation or organization)
(I.R.S. Employer
Identification No.)
65 Hayden Avenue Lexington MA
02421
(Address of principal executive offices)
(Zip Code)
(617) 674-9000
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, $0.001 Par Value
KLDO
NASDAQ Global Select Market
Securities registered pursuant to section 12(g) of the Act:
None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period
that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the
preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definitions of “large
accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
☐
Accelerated filer
☐
Non-accelerated filer
☒
Smaller reporting company
☒
Emerging growth company
☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-
Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐
Indicate by check mark whether registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of June 30, 2021, the last day of the registrant’s most recently completed second fiscal quarter, the aggregate market value of the registrant's common stock held by non-affiliates was approximately $142.28
million based on the closing price of the registrant’s common stock on June 30, 2021. The calculation excludes shares of the registrant’s common stock held by current executive officers, directors and stockholders that the
registrant has concluded are affiliates of the registrant. This determination of affiliate status is not a determination for other purposes.
As of March 31, 2022, there were 42,622,559 shares of registrant’s common shares outstanding.
FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains forward-looking statements, which reflect our current views with respect to, among other things, our operations
and financial performance. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform
Act of 1995 and other federal securities laws. All statements other than statements of historical facts contained in this Annual Report on Form 10-K,
including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plan, objectives of
management and expected market growth are forward-looking statements that involve risks and uncertainties. You can identify these forward-looking
statements by the use of words such as “outlook,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “seeks,” “approximately,”
“predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. Accordingly, there are or will
be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. We believe these factors
include but are not limited to those described under “Risk Factors” and include, among other things:
•
our plans and expectations regarding our strategic alternative review process and the timing and success of such process regarding a potential
transaction;
•
success in retaining, or changes required in, our officers, key employees or directors;
•
our public securities' potential liquidity and trading;
•
our ability to obtain funding for our operations, when needed, including funding necessary to complete further development and
commercialization of our product candidates, if approved, and to further expand our propriety product platform;
•
our ability to continue as a going concern, including without limitation our ability to continue to advance the clinical development of our
MMT candidates;
•
the success, cost and timing of our research and development activities, including statements regarding the timing of initiation and
completion of clinical studies or clinical trials and related preparatory work, and the period during which the results of the clinical studies or
clinical trials will become available;
•
our ability to advance any product candidate into or successfully complete any clinical trial or identify an alternative commercial pathway for
such product candidate;
•
our ability or the potential to successfully manufacture our product candidates for clinical studies, clinical trials or commercial use, if
approved;
•
the accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
•
our expectations regarding the timing for proposed submissions of regulatory filings, including but not limited to any Investigational New
Drug application filing or any New Drug Applications;
•
our ability to maintain regulatory approval, if obtained, of any of our current or future product candidates, and any related restrictions,
limitations and/or warnings in the label of an approved product candidate;
•
our ability to commercialize our product candidates in light of the intellectual property rights of others;
•
our ability to attract collaborators with development, regulatory, commercialization, or other relevant expertise;
•
the expected results pursuant to collaboration arrangements including the receipts of future payments that may arise pursuant to collaboration
arrangements;
•
existing and future agreements with third parties in connection with the research and development or commercialization of our product
candidates;
•
the size and growth potential of the markets for our product candidates, and our ability to serve those markets either alone or in collaboration
with others;
•
the rate and degree of market acceptance of our product candidates;
•
the success of competing therapies that are or become available;
•
our ability to contract with third-party suppliers and manufacturers and their ability to perform their obligations adequately;
•
the impact of changes in existing laws, regulations and guidance or the adoption of new laws, regulations and guidance;
•
our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates and other
technologies;
•
the impact of the COVID-19 outbreak on our clinical trial programs and business generally, as well as our plans and expectations with
respect to the timing and resumption of any development activities that may be temporarily paused as a result of the COVID-19 outbreak;
and
•
the ultimate impact of the current coronavirus pandemic, or any other health epidemic, on our business, our clinical trials, our research
programs, healthcare systems or the global economy as a whole.
All of our forward-looking statements are as of the date of this Annual Report on Form 10-K only. In each case, actual results may differ materially from
such forward-looking information. We can give no assurance that such expectations or forward-looking statements will prove to be correct. An occurrence
of or any material adverse change in one or more of the risk factors or risks and uncertainties referred to in this Annual Report on Form 10-K or included in
our other public disclosures or our other periodic reports or other documents or filings filed with or furnished to the Securities and Exchange Commission,
or the SEC, could materially and adversely affect our business, prospects, financial condition and results of operations. Except as required by law, we do
not undertake or plan to update or revise any such forward-looking statements to reflect actual results, changes in plans, assumptions, estimates or
projections or other circumstances affecting such forward-looking statements occurring after the date of this Annual Report on Form 10-K, even if such
results, changes or circumstances make it clear that any forward-looking information will not be realized. Any public statements or disclosures by us
following this Annual Report on Form 10-K that modify or impact any of the forward-looking statements contained in this Annual Report on Form 10-K
will be deemed to modify or supersede such statements in this Annual Report on Form 10-K.
We caution readers not to place undue reliance on any forward-looking statements made by us, which speak only as of the date they are made. We disclaim
any obligation, except as specifically required by law and the rules of the U.S. Securities and Exchange Commission, to publicly update or revise any such
statements to reflect any change in our expectations or in events, conditions or circumstances on which any such statements may be based, or that may
affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
SUMMARY RISK FACTORS
Our business is subject to numerous risks and uncertainties that you should be aware of in evaluating our business. These risks include, but are not limited
to, the following:
•
We may not be successful in identifying and implementing any strategic business combination or other transaction and any strategic
transaction that we may consummate in the future could have negative consequences. If a strategic transaction is not consummated, our
Board may decide to pursue a dissolution and liquidation.
•
We may not realize any additional value in a strategic transaction.
•
If we are successful in completing a strategic transaction, we may be exposed to other operational and financial risks.
•
Our ability to consummate a strategic transaction depends on our ability to retain our employees required to consummate such a transaction.
•
The impact and results of our ongoing strategic process are uncertain and may not be successful.
•
We may become involved in securities class action litigation that could divert management's attention and harm the company's business, and
insurance coverage may not be sufficient to cover all costs and damages.
•
We have incurred net losses in every year since our inception and anticipate that we will continue to incur net losses in the future.
•
We will require additional capital to fund our operations and if we fail to obtain necessary financing, we will not be able to complete
development and commercialization of our product candidates.
•
Clinical development is a lengthy and expensive process, with an uncertain outcome. We may incur additional costs or experience delays in
completing, or ultimately be unable to complete, the development and commercialization of any product candidates, which could impair our
ability to fund our operations or obtain financing on acceptable terms, or at all.
•
The successful development of our product candidates is highly uncertain.
•
We are very early in our development efforts. Our drug product candidates will require significant additional preclinical and clinical
development before we seek regulatory approval for and launch a drug product commercially. If we elect to bring product candidates to
market as non-drug products, additional development would be required, and all of our product candidates may require significant
interactions with regulatory authorities and investments before their respective commercial launches. If we are unable to advance our product
candidates to final development, meet regulatory requirements, including obtaining regulatory approval, where applicable, or ultimately
commercialize our product candidates or experience significant delays in doing so, our business will be materially harmed.
•
We face significant competition from other healthcare companies, and our operating results will suffer if we fail to compete effectively.
•
COVID-19 and COVID related events may materially and adversely affect our business and our financial results.
•
If we are unable to obtain and maintain patent protection for any product candidates we develop or for our development platform or other
technologies, our competitors could develop and commercialize products or technology similar or identical to ours, and our ability to
successfully commercialize any product candidates we may develop, and our technology may be adversely affected.
•
We rely on third parties to conduct our Clinical Studies and will rely on third parties to conduct any Clinical Trials for any product candidate
that we decide to develop as a drug product candidate and to assist us in meeting the regulatory requirements applicable to development and
marketing of our products. If these third parties do not successfully carry out their contractual duties or meet expected deadlines or comply
with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize any potential product candidates.
•
We have experience manufacturing our product candidates only for purposes of our ongoing and completed Clinical Studies to date, and have
very limited experience manufacturing our product candidates for the purposes of Clinical Trials, or at commercial scale, and if we decide to
establish our own manufacturing facility for our product candidates, we cannot assure you that we can manufacture our product candidates in
compliance with regulations at a cost or in quantities necessary to make them commercially viable.
•
The trading price of our stock is highly volatile.
The summary risk factors described above should be read together with the text of the full risk factors below and in the other information set forth in this
Annual Report on Form 10-K, including our consolidated financial statements and the related notes, as well as in other documents that we file with the
SEC. If any such risks and uncertainties actually occur, our business, prospects, financial condition and results of operations could be materially and
adversely affected. The risks summarized above or described in full below are not the only risks that we face. Additional risks and uncertainties not
currently known to us, or that we currently deem to be immaterial may also materially adversely affect our business, prospects, financial condition and
results of operations.
KALEIDO BIOSCIENCES, INC. AND SUBSIDIARIES
TABLE OF CONTENTS
Page
Number
PART I:
7
Item 1.
Business
7
Item 1A.
Risk Factors
32
Item 1B.
Unresolved Staff Comments
91
Item 2.
Properties
91
Item 3.
Legal Proceedings
91
Item 4.
Mine Safety Procedures
91
PART II:
92
Item 5.
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
92
Item 6.
Selected Financial Data
92
Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
93
Item 7A.
Quantitative and Qualitative Disclosures About Market Risk
102
Item 8.
Financial Statements and Supplementary Data
103
Item 9.
Changes in and Disagreements With Accountants on Accounting and Financial Disclosure
124
Item 9A.
Controls and Procedures
124
Item 9B.
Other Information
125
PART III:
126
Item 10.
Directors, Executive Officers and Corporate Governance
126
Item 11.
Executive Compensation
129
Item 12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
139
Item 13.
Certain Relationships and Related Transactions, and Director Independence
142
Item 14.
Principal Accounting Fees and Services
146
PART IV:
148
Item 15.
Exhibits, Financial Statement Schedules
148
Item 16.
Form 10-K Summary
150
Signatures
151
PART I
In this Annual Report on Form 10-K, we use the following defined terms.
We utilize our human-centric discovery and development platform to study Microbiome Metabolic Therapies, or MMTs, in microbiome samples in an ex
vivo setting, followed by advancing MMT candidates rapidly into clinical studies in healthy subjects and patients. “Clinical studies” are conducted under
regulations supporting research with food, evaluating safety, tolerability and potential markers of effect. For MMT candidates that are further developed as
therapeutics, we conduct “Clinical trials” under an Investigational New Drug application, or IND, or comparable foreign regulatory equivalents outside the
U.S., and in Phase 2 or later development.
KALEIDO is a registered trademark and MMT is a trademark of Kaleido Biosciences, Inc. in the United States and in other selected countries. All other
brand names or trademarks appearing in this report are the property of their respective holders. Unless the context requires otherwise, references in this
report to “KALEIDO,” “Kaleido Biosciences,” “our Company,” “the Company,” “we,” “us,” and “our” refer to Kaleido Biosciences, Inc. and its
consolidated subsidiaries.
Item 1. Business
Overview
We have initiated a process to explore a range of strategic alternatives to maximize shareholder value and have engaged professional advisors, including an
investment banker to act as a strategic advisor for this process. Potential strategic alternatives that may be evaluated include a sale or merger of the
Company or securing additional financing or partnerships that would enable further development of our programs. There can be no assurance that this
strategic review process will result in our pursuing any transaction or that any transaction, if pursued, will be completed. We aim to run this strategic review
process into mid-April 2022. Additionally, there can be no assurances that any particular course of action, business arrangement or transaction, or series of
transactions, will be pursued, successfully consummated or lead to increased stockholder value. If the strategic process is unsuccessful, our Board may
decide to pursue a dissolution and liquidation. In the event of such liquidation or other wind-down event, holders of our securities will likely suffer a total
loss of their investment.
We are a clinical-stage healthcare company with a differentiated, chemistry-driven approach focused on leveraging the microbiome to treat disease and
improve human health. We have built a human-centric proprietary product platform for discovery and development that we believe will enable the
advancement of a broad portfolio of novel product candidates. Our product candidates are Microbiome Metabolic Therapies (“MMT” or “MMTs”) which
are designed to modulate the metabolic output and profile of the microbiome by driving the function and composition of existing microbes. We have an
industrialized approach to the discovery and development of MMTs, and our initial MMTs are targeted glycans. Each targeted glycan is an ensemble of
complex carbohydrates that is intended to modulate microbial metabolism and community composition to drive a specific biological response. We believe
our MMTs have the potential to be novel treatments across a variety of diseases and conditions.
The human microbiome is generally a community of more than 30 trillion microbes, organisms that include bacteria, viruses, archaea and fungi, which
reside on and inside the human body. By evolving together over thousands of years, microbes and humans have developed an intricate and mutually
beneficial relationship. Given the profound impact that microbes have on human health, this highly complex microbial ecosystem has been referred to as a
“newly discovered organ.” There is a growing body of research that links a healthy microbiome with overall human health, while dysbiosis, or imbalance,
in the microbiome has been correlated with numerous human conditions including those that cause significant morbidity and mortality. Some of these
conditions include irritable bowel syndrome, Parkinson’s disease, diabetes, metabolic syndrome, cancer, allergies and ulcerative colitis.
To date, therapeutic approaches to the microbiome have focused primarily on adding or subtracting bacteria, either through fecal microbiota transplant, the
introduction of a consortia of bacteria, single strain approaches or antibiotics. We believe our approach is novel in that we seek to deliver MMTs that drive
the function and
7
distribution of the gut microbiome’s existing microbes, enabling an industrialized approach to treat disease and improve human health.
We have developed proprietary synthetic chemistry technologies that allow us to create MMT candidates. We believe the key characteristics of our MMT
candidates include that they are orally administered, have limited systemic exposure and are selectively metabolized, structurally diverse, readily scalable,
novel and proprietary. We believe that each of our MMT candidates works through one or more mechanisms of action, including selectively targeting the
resident microbiome to restore gut-immune homeostasis.
Utilizing our proprietary product platform, we have created a library of more than 1,500 MMT candidates to probe the structure-activity relationships of
our MMTs. Our MMT candidates and aspects of the proprietary product platform are supported by our expanding intellectual property portfolio, that
includes fifteen U.S. patents, four European Patent Office, or EPO, patents and more than 115 non-provisional applications pending worldwide.
Through the use of our proprietary product platform, the effect of MMTs is first tested ex vivo using a highly multiplexed advanced screening platform
with microbiome communities from both healthy and patient populations. To establish how MMTs impact therapeutically relevant pathways, a broad range
of bioanalytical technologies are used to analyze metabolites, effector molecules and host responses, while sequencing determines key microbial
community changes. A candidate MMT may then either undergo further testing in animal models or go straight into clinical evaluation in humans.
Abbreviated development may be possible because in some cases MMTs are synthesized from naturally occurring carbohydrate monomers, are orally
administered with limited systemic exposure and can be designated as Generally Recognized as Safe (GRAS). This enables us to gain valuable insights into
our MMT candidates’ effects on the microbiome and human health before choosing to allocate additional time and capital to proceed to develop a drug
product candidate under an IND or regulatory equivalent outside the United States. In August 2021, we received a warning letter from the FDA for failure
to submit an IND prior to conducting two clinical studies, K031 and K032, of KB109 in subjects with COVID-19. Receipt of this warning letter raises
doubt that we will be able to conduct future clinical studies of our product candidates utilizing this pathway.
We, and our wholly owned subsidiaries, Cadena Bio, Inc. and Kaleido Biosciences Securities Corporation (collectively referred to as the “Company”) were
incorporated in Delaware on January 27, 2015 and have a principal place of business in Lexington, Massachusetts.
8
Our Strategy
Our immediate strategy is to:
•
Continue our strategic process to explore strategic alternatives. We have initiated a process to explore a range of strategic alternatives to
maximize shareholder value and have engaged professional advisors, including an investment bank, to act as strategic advisors for this
process. Potential strategic alternatives that may be evaluated include a sale or merger of the Company or securing additional financing or
partnerships that would enable further development of our programs. There can be no assurance that this strategic review process will result
in our pursing any transaction or that any transaction, if pursed, will be completed. We aim to run this strategic review process into mid-April
2022.
In the event that our strategic process is successful, key elements of our strategy are to:
•
Harness the insights and data generated through our human-centric proprietary product platform to efficiently and rapidly advance a
pipeline of MMTs to ultimately deliver products that address significant unmet patient needs.
•
Leverage our differentiated approach, knowledge and unique expertise to lead efforts to expand the scientific understanding of the
microbiome and its impact on human health.
•
Advance pipeline programs in disease areas with an established connection between the microbiome and the disease.
•
Selectively enter into strategic partnerships to maximize the value of our platform and pipeline.
•
Further strengthen and expand our intellectual property portfolio.
•
Build on our foundation of people who are committed to scientific innovation, transforming lives and fostering a strong culture.
Our Approach
Due to the rapid nature of bacterial growth, the microbiome is inherently amenable to swift change, and it can be readily modulated using existing
approaches, such as changes in diet and treatment with antibiotics. Importantly, because microbes in the gut can thrive on compounds, in particular glycans,
that are generally not bioavailable to humans, effective targeted modulators of microbial metabolism should have low bioavailability and low systemic
exposure. As a result, we believe that targeted modulators will likely have limited off-target activity in humans compared with traditional pharmaceutical
agents.
Our MMTs
We have developed proprietary synthetic chemistry technologies that we believe allow us to create our MMT candidates. MMTs are novel synthetic
glycans that serve as metabolic and growth substrates for the microbiome. We believe the key characteristics of our MMT candidates include the following:
•
Orally administered — Our MMT candidates are highly soluble and are orally administered.
•
Limited systemic exposure — Our MMT candidates have been observed to have limited systemic exposure after oral administration,
minimizing off-target biological effects.
9
•
Selectively metabolized — We design MMT candidates that are selectively metabolized by bacteria in the microbiome through the use of
specialized enzymes. Species of gut bacteria are ecologically differentiated by their abilities to metabolize different glycans, making glycan
delivery a powerful way to specifically modulate the composition, activity and metabolic output of the microbiome and improve host health.
•
Structurally diverse — Our MMT candidates are not a single, structurally-defined molecule, but rather an ensemble of molecules with a
variety of structures. This structural complexity and specificity of action differentiates MMTs from any individual dietary fiber, and we
believe that this is the primary factor for their differentiated microbiome activity.
•
Readily scalable — Our MMT candidates are produced using proprietary, standard small molecule unit operations. These methods have
been proven scalable.
•
Novel and proprietary — Our MMT candidates are protected by what we believe to be a robust intellectual property portfolio, including by
composition of matter and method of use patents.
We believe that our MMT candidates work through one or more mechanisms of action that may have profound effects on human health in a variety of
diseases and adverse conditions, including by selectively targeting the resident microbiome to restore gut-immune homeostasis.
MMT Synthesis
We synthesize MMT candidates using our proprietary chemistry technologies, which take advantage of the reactivity of carbohydrates and utilize defined
mixtures of monosaccharides or polysaccharides as starting materials. We have methodically explored this approach to create a library of initial MMT
candidates that vary across a wide range of structural features, including molecular weight, branching, regiochemistry and stereochemistry. By changing
certain conditions and parameters, we can generate MMT candidates that have both larger and smaller variances on these structural features. The resulting
MMT candidate library can then be used to explore the impact that structure has on the biology of the microbiome. We continue to develop other novel
approaches to synthesize MMT candidates.
We have made extensive commitments to discovering cost-effective and proprietary synthetic methods that can produce MMT candidates that drive diverse
microbial responses. We believe our computational capabilities enable robust, efficient structural characterization and cross-batch comparison, reducing
laborious manual processing steps typically required to determine the structure of complex carbohydrates.
We developed an ex vivo assay that allows the efficient and highly multiplexed screening MMT candidates using healthy volunteer and patient
microbiomes. This unique screening and lead-identification process combines advances in drug discovery with microbiome science and is designed to
measure the impact of MMTs on a variety of endpoints. To date, we have employed this process to screen a majority of our more than 1,500 MMT
candidates for their ability to modulate bacterial metabolites with a documented role in the microbiome-host cross talks underlying the risk for, onset of and
progression of disease. In addition, we have deployed this to measure, bacterial growth and community composition. Typically, after screening our library
in microbiome samples from healthy volunteers, we test the identified lead compounds in samples from the patient population of interest. This provides the
evidence needed to progress directly into clinical studies in healthy subjects, and in many cases, directly into patients or employ additional clinically
relevant animal models. Furthermore, we utilize specific in vitro as well as animal models to test hypothesis on mechanism of action.
Rapid advancement into human clinical studies
Regulatory approach: food and drug
Our regulatory approach to developing MMT candidates utilizes clinical research under both food law and drug law. Under this approach, human data is
collected earlier in the process as compared to traditional drug development and data collected under both clinical studies and clinical trials may be
included in regulatory filings, including filings for marketing approval. The MMT candidates we have been evaluating for use in modulating the
microbiome can be classified as food or as drug ingredients depending upon their intended use. When intended for nutrient use to affect the structure or
function of the body, they are conventional food or dietary supplement ingredients. For the dietary management of disease, the MMTs could be developed
as medical foods. When intended for the prevention, cure, diagnosis or treatment of disease, they are drug candidates. We have initially studied several of
our MMT candidates
10
following food regulation and guidance. These clinical studies are run under guidelines for Good Clinical Practice (“GCP”) and collect similar data as
studies run under an IND or CTA. Therefore, these data can support filing an IND at Phase 2 or later, with the ultimate decision based on discussions with
the U.S. Food and Drug Administration (“FDA”) or comparable foreign regulatory authorities.
Food substances for human use are regulated by the FDA to assure that intended exposures are safe in the general population. This assurance can be
provided by a food additive regulation, or by determination by qualified experts that the substance is Generally Recognized as Safe (“GRAS”).
Although food additives must be evaluated by the FDA’s Office of Food Additive Safety through a food additive petition prior to human use, this
requirement excludes “substances that are generally recognized, among experts qualified by scientific training and experience to evaluate their safety as
having been adequately shown to be safe under the conditions of their intended use.” This can be established through a GRAS determination.
For a substance to be determined to be GRAS, the scientific data and information about its use must be widely known, and there must be a consensus
among qualified experts that data and information establish that the substance is safe under the conditions of its intended use and that it meets the standard
of “reasonable certainty of no harm.”
A GRAS determination by qualified experts is sufficient to support clinical studies of food in humans. We rely on qualified experts from scientific
consulting organizations that are highly experienced in conducting both GRAS evaluations to conduct initial safety assessments of our MMT candidates.
These third-party assessments evaluate whether our MMTs are safe for intended use in human clinical studies that are intended to evaluate safety and
tolerability and the effects of our MMTs on the structure and function of the microbiome. The resulting conclusion that a substance is GRAS is called a
self-determination of GRAS.
Our MMT candidates have been observed to have limited systemic exposure after oral administration, minimizing off-target biological effects. The direct
adverse effects that we have observed to date are limited to the symptoms associated with bacterial metabolism when orally administered, such as bloating,
flatulence, abdominal cramping and pain and diarrhea, and not those generally associated with systemic exposure. These symptoms are the known dose
limiting side effects, and they are localized and generally found to be mild and transient. We believe that we can achieve significantly higher doses with our
MMT candidates before triggering dose-limiting side effects, unlike naturally occurring complex carbohydrates, which often result in tolerability
challenges at even moderate dosage levels.
When a food substance is intended for the diagnosis, cure, treatment or prevention of disease, then it is regulated as a drug ingredient. If our corporate
strategy supports development of an MMT as a drug product, we will need to file an IND with FDA and obtain IND clearance from the FDA before
commencing therapeutic clinical trials. An IND requires submission of additional information, including the information that supports the safety of the
product for the intended population to be studied and planned exposure, non-clinical toxicology, details of the manufacturing and testing, and clinical
protocols describing the proposed human therapeutic clinical trial(s). Equivalent requirements apply for drug clinical studies to be conducted outside the
U.S.
Ulcerative Colitis
Disease overview
Ulcerative colitis (“UC”) is a chronic disease of the large intestine, in which the lining of the colon becomes inflamed and develops tiny open sores, or
ulcers. Those ulcers produce pus and mucus, cause abdominal pain and result in the need to frequently empty the colon. UC is the result of several factors
that are not yet well understood. Abnormal immune response, genetics, microbiome, and environmental factors all contribute to the disease. There is no
medical cure for UC and it can occur at any age, though most people are diagnosed prior to their mid-30s. In the United States, approximately one million
people are affected with UC. The disease symptoms vary from person to person and over half of all UC patients experience mild-to-moderate symptoms.
Reported symptoms include loose stool and urgent bowel movements, bloody stool, abdominal cramps and pain, and persistent diarrhea accompanied by
abdominal pain and blood in the stool.
11
Currently available therapies
There is no known curative treatment for the disease. Treatment is multifaceted and includes the use of medication, alterations in diet and nutrition, and
sometimes surgical procedures to repair or remove affected portions of a patient’s gastrointestinal tract.
Several types of medication can be used to suppress UC symptoms (induce remission) and decrease the frequency of symptom flares (maintain remission)
including anti-inflammatory drugs, immunosuppressants, and biologics. UC is often a progressive disease meaning that over time patients respond less to a
specific medication and need to progress to other treatments.
Ulcerative Colitis and KB295
Evidence suggests that a feature of UC is alteration of the gut microbiome, including an increase in pro-inflammatory bacteria and decrease in commensal
diversity which interfere with the normal immune response. In ex vivo studies, KB295 has demonstrated the ability to increase the production of short chain
fatty acids and suppress the growth of inflammatory bacteria such as Enterobacteriaceae.
We conducted a non-IND clinical study evaluating MMT candidate KB295 in patients with mild-to-moderate UC. In this non-IND open label, single arm
clinical study patients with mild-to-moderate UC received KB295 for eight weeks titrated up to 40g twice daily and then enter a one-month follow-up
period. The study evaluated the safety and tolerability of KB295 and other assessments including the Simple Clinical Colitis Activity Index composite
score, changes in microbiome composition and biomarkers of inflammation.
Infections caused by pathogenic bacteria including multi-drug resistant strains
Scientific rationale
Gut commensal bacteria minimize colonization of potential pathogens and maintain the intestinal barrier, thus preventing pathogen translocation to the
bloodstream and other organs that ultimately causes infection. A diverse microbiome has been associated with numerous positive health outcomes. The
administration of chemotherapy or antibiotics reduces diversity of the microbiome, interfering with its ability to perform these critical protective functions.
We believe one potential way to restore the diversity of commensal bacteria is through administration of MMTs that can be metabolized exclusively by
commensal bacteria, but not by pathogens. This strategy may therefore increase the diversity and biomass of the commensal microbiota and lead to a
reduction in the abundance of pathogens. MMTs thus represent an antibiotic-sparing approach with no known mechanism of resistance for the fight against
infectious disease caused by MDR bacteria.
Disease overview
Multi-drug resistant (“MDR”) pathogens are a significant and growing global health threat. In the United States alone, antibiotic resistant bacteria cause
infections in more than 2.8 million people per year, and this number is growing. As antibiotics become less effective for the treatment and prevention of
infectious diseases, infections that were once easily managed have become progressively more difficult to treat. Patients who develop MDR infections
consume more healthcare resources and have a higher mortality rate than patients infected with non-resistant strains of the same bacteria.
The risk of MDR pathogen colonization is significantly increased in patients with compromised immune systems, those on long term antibiotics, and those
with protracted hospitalizations. Our initial focus is in patients scheduled to undergo hematopoietic stem cell transplantation (“HSCT”), a population at
high risk of infection in addition to other pathologies where the microbiome is documented to have an impact (Febrile neutropenia, Graft-versus-host-
disease). HSCT is used for the treatment of cancer and certain autoimmune diseases. Bacterial infections are common after HSCT, due to pre-transplant
immune system ablation. The use of prophylactic antibiotics was instituted to reduce the rate of such infections; however careful studies of mortality have
shown that their use is associated with a significantly increased rate of death. Patients with low microbiome diversity had a significantly greater mortality
than those maintaining a high diversity (67% vs 36% mortality at three years). This is thought to be mediated by the adverse effect the antibiotics have on
the microbiome. The dysbiotic microbiome in turn facilitates colonization with pathogenic organisms, which may then lead to infection. These infections
are a significant cause of patient mortality, excluding mortality due to the primary disease. In the United States, approximately 23,000 patients undergo
HSCT each year.
12
Currently available therapies
While there are no treatments currently approved for prevention of infections in patients scheduled to receive HSCT, some clinicians treat patients
prophylactically with an antibiotic from one of several classes, such as quinolones, beta-lactams or glycopeptides. If a patient develops an infection, they
are treated empirically with antibiotics based on the likely organism and site of infection. While a significant number of antibiotics are commercially
available, delays in treating an infection with an effective antibiotic is associated with increased morbidity and mortality, and some MDR infections have
limited or no effective treatment options.
MMT candidates—KB109 and KB174
KB109 and KB174 are the MMT candidates for development as a potential prevention of infections caused by MDR bacteria. Nomination of these
candidates resulted from their performance relative to a wide range of other MMTs in ex vivo screening of microbiome samples from healthy volunteers, as
well as microbiome samples from intensive care unit patients in an experimental set-up that specifically focused on determining the potential of MMTs to
decrease the relative abundance of a panel of pathogenic bacteria.
The initial opportunity is to prevent systemic infections in patients undergoing HSCT. Prophylactic treatment with antibiotics lowers gut microbiome
diversity and is associated with a higher mortality rate after HSCT. KB109 is a non-antibiotic approach that is hypothesized to selectively enhance the
growth of beneficial gut bacteria at the expense of pathogens (e.g. carbapenem-resistant enterobacteriaceae, Vancomycin-resistant enterococcus, and
extended spectrum beta-lactamase-producing enterobacteriaceae) which may then reduce the risk of subsequent infection. Prior to studying patients
undergoing HSCT, we initiated a first-in-human clinical trial in medically stable patients colonized with MDR pathogens but this study was terminated due
to enrollment challenges caused by the COVID-19 pandemic and the desire to utilize KB109 for our COVID-19 studies.
Future pipeline opportunities
If sufficient funding were available, we could pursue a number of opportunities beyond our initial pipeline. Our proprietary product platform is designed to
generate the knowledge and insights required to support discovery and development work in a wide range of areas, including where evidence of a link to
the microbiome exists but the biology is not yet fully defined. We believe that these areas of more complex microbiome-human biology present an
opportunity to leverage our human-centric discovery and development approach and computational expertise.
We have or have had programs in discovery, including work in ulcerative colitis, psoriasis, atopic immune disease, chronic obstructive pulmonary disease
("COPD"), pathogens, and immuno--oncology. Correlative data has been published for each of these areas suggesting that the microbiome plays a critical
role, and our discovery efforts have been largely focused on either establishing a mechanistic hypothesis or establishing and optimizing an ex vivo screen to
address these opportunities. Some of this work has been conducted through collaborations, including with Institute Gustave Roussy in Paris exploring the
potential of MMTs to improve the outcome of immune checkpoint inhibitor (“ICI”) treatment, with Jeffrey Gordon at Washington University (St. Louis)
studying the mechanisms by which selected MMT candidates are metabolized by the gut microbiome and the impact on key functions in the host, and with
Janssen focusing on decreasing the risk of the development of child-onset atopic diseases, including food allergies. We will advance MMT candidates once
identified for future pipeline opportunities.
As of the date of this Annual Report on Form 10-K, given the strategic process we are running, our active development initiatives are extremely limited.
Manufacturing
We have developed proprietary methods for the manufacture of MMT candidates that we believe are scalable and transferable to current good
manufacturing practice requirements (“cGMP”). Our MMT candidates are synthesized and isolated using standard small molecule unit operations. The
manufacturing process produces bulk MMT candidates suitable for oral administration in a variety of forms, including liquids and spray dried powders in
sachets. In addition, we have established robust analytical methods to assess the identity and purity of our MMT
13
candidates. We believe that these controlled manufacturing processes and analytical methods will allow us to produce and release cGMP batches of
material with consistent quality.
We would rely on third-party manufacturers for the GMP production of larger quantities of MMT candidates for clinical trials.
While we do not have a current need for commercial scale manufacturing capacity, at the appropriate time we intend to evaluate options for further
engaging our existing third-party manufacturers and/or building our own pharmaceutical grade cGMP internal capabilities.
Intellectual property
Overview
We strive to protect the proprietary technology that we believe is important to our business, including seeking and maintaining patent protection in the
United States and internationally for our product candidates and discovery platform. We also rely on trademarks, trade secrets, know-how, continuing
technological innovation and in-licensing opportunities to develop and maintain our proprietary position.
We plan to continue to expand our intellectual property estate by filing patent applications directed to pharmaceutical compositions, methods of treatment,
methods of manufacture or identified from our ongoing development of our product candidates, as well as discovery based on our proprietary product
platform. Our level of success will depend on our ability to obtain and maintain patent and other proprietary protection for commercially important
technology, inventions and know-how related to our business, defend and enforce any patents that we may obtain, preserve the confidentiality of our trade
secrets and operate without infringing the valid and enforceable patents and proprietary rights of third parties.
The patent positions of biopharmaceutical companies like us are generally uncertain and involve complex legal, scientific and factual questions.
Consequently, we may not obtain or maintain adequate patent protection for any of our programs and product candidates.
For more information regarding the risks related to our intellectual property, see “Risk Factors—Risks Related to Our Intellectual Property.”
Patent portfolio
Our patent portfolio includes patent applications in varying stages of prosecution in the United States and selected jurisdictions outside of the United States.
As of March 31, 2022, our patent portfolio in total consisted of fifteen issued U.S. patents, four issued European patents, twenty-two issued patents in
other jurisdictions (Argentina, Australia, Brazil, Canada, China, Colombia, Hong Kong, India, Indonesia, Israel, Malaysia, Mexico, New Zealand,
Philippines, Singapore and South Africa), and over 115 pending non-provisional applications (U.S., EP and other jurisdictions), which include claims
directed to compositions, methods of use and manufacturing processes. All patents are owned by us. Certain patents and patent applications described
above are licensed exclusively to Midori USA, Inc. for use in the animal health field.
The patent portfolio includes patents and applications (numbers for U.S. and Europe only) with claims directed to the following:
MMT platform
We own seven issued U.S. patents (U.S.11,169,101; 10,752,705; 10,131,721; 9,205,418; 9,079,171; 8,476,388; and 8,466,242), two issued EP patents (EP
3071235 and EP 2681247), and several pending patent families (with national, non-provisional applications) containing composition of matter, method of
making and use claims related to our MMT platform and KB195, KB174, KB109, and KB295. The issued patents in the earliest of these families are
expected to expire in 2032, not including any patent term adjustments and any patent term extensions.
14
COVID-19
We own one pending PCT application containing composition of matter, method of treatment and use claims related to our COVID-19 program and
KB109. The issued patents in the earliest of these families are expected to expire in 2038, not including any patent term adjustments and any patent term
extensions.
Ulcerative Colitis
We own one issued U.S. patent (U.S. 10,881676), pending national, non-provisional applications containing composition of matter, method of treatment
and use claims related to our ulcerative colitis program and KB295. The issued patents in the earliest of these families are expected to expire in 2036, not
including any patent term adjustments and any patent term extensions.
Urea Cycle Disorders ("UCD") and Hepatic Encephalopathy ("HE")
We own one issued U.S. patent (U.S. 9,901,595), and several pending national, non-provisional application containing composition of matter, method of
treatment and use claims related to our UCD and HE programs and KB195 and KB174. The issued patents in the earliest of these families are expected to
expire in 2036, not including any patent term adjustments and any patent term extensions.
Pathogen
We own two issued U.S. patents (U.S. 10,314,853; 9,757,403), one issued EP patent (EP 3071235), and several pending national, non-provisional
applications containing method of treatment and use claims related to our pathogen program. The issued patents in the earliest of these families are
expected to expire in 2036, not including any patent term adjustments and any patent term extensions.
Patent term
The term of individual patents depends upon the legal term of the patents in the countries in which they are obtained. In most countries in which we file,
including the U.S., the base term is 20 years from the filing date of the earliest-filed non-provisional patent application from which the patent claims
priority. The term of a U.S. patent can be lengthened by patent term adjustment. In some cases, the term of a U.S. patent is shortened by terminal disclaimer
that reduces its term to that of an earlier-expiring patent. The term of a U.S. patent may be eligible for patent term extension under the Drug Price
Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Act. With regard to a drug for which FDA approval is the first
permitted marketing of the active ingredient, the Hatch-Waxman Act allows for extension of the term of one U.S. patent that includes at least one claim
covering the composition of matter of such an FDA-approved drug, an FDA-approved method of treatment using the drug and/or a method of
manufacturing the FDA-approved drug. The extended patent term cannot exceed the shorter of five years beyond the non-extended expiration of the patent
or fourteen years from the date of the FDA approval of the drug, and a patent cannot be extended more than once or for more than a single product. During
the period of extension, if granted, the scope of exclusivity is limited to the approved product for approved uses. Some foreign jurisdictions, including
Europe and Japan, have analogous patent term extension provisions, which allow for extension of the term of a patent that covers a drug approved by the
applicable foreign regulatory agency.
If and when our product candidates receive FDA approval, we expect to apply, if appropriate, for patent term extension on patents directed to those product
candidates, their methods of use and/or methods of manufacture. However, there is no guarantee that the applicable authorities, including the FDA in the
United States, will agree with our assessment of whether such extensions should be granted, and if granted, the length of such extensions. For more
information regarding the risks related to our intellectual property, see “Risk Factors—Risks Related to Our Intellectual Property.”
15
Trade secrets
In addition to patents, we rely on trade secrets and know-how to develop and maintain our competitive position. We typically rely on trade secrets to
protect aspects of our business that are not amenable to, or that we do not consider appropriate for, patent protection.
Although we take steps to protect our proprietary information and trade secrets, including through contractual means with our employees and consultants,
third parties may independently develop substantially equivalent proprietary information and techniques or otherwise gain access to our trade secrets or
disclose our technology. Thus, we may not be able to meaningfully protect our trade secrets. For more information regarding the risks related to our
intellectual property, see “Risk Factors — Risks Related to Our Intellectual Property.”
Competition
The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, strong competition and an emphasis on proprietary
products. While we believe that our technology, knowledge, experience and scientific resources provide us with competitive advantages, we face
substantial competition from many different sources, including larger pharmaceutical companies with more resources. Specialty biotechnology companies,
academic research institutions, governmental agencies, as well as public and private institutions are also potential sources of competitive products and
technologies. We believe that the key competitive factors affecting the success of any of our product candidates will include efficacy, safety profile, method
of administration, cost, level of promotional activity and intellectual property protection.
The field of microbiome drug development is rapidly evolving and although there are currently many bacterial product candidates in development by
companies that target the microbiome, we believe that we have a differentiated approach and do not consider ourselves to be in competition with these
bacterial microbiome approaches.
Although our novel chemistry approach is unique from most other existing or investigational therapies across the disease areas where our development is
focused, we will need to compete with all currently or imminently available therapies in these areas. We are aware of marketed and investigational products
in each of our leading disease areas.
Government regulation
The FDA and other regulatory authorities at federal, state and local levels, as well as in foreign countries, extensively regulate, among other things, the
research, development, testing, manufacture, quality control, import, export, safety, effectiveness, labeling, packaging, storage, distribution, record keeping,
approval (when required), advertising, promotion, marketing, post-approval monitoring and post-approval reporting of drugs such as those we are
developing as well as dietary non-drug products and foods. We, along with our contract research organizations and contract manufacturers, will be required
to navigate the various preclinical, clinical, manufacturing and commercial approval requirements of the governing regulatory agencies of the countries in
which we wish to conduct studies or seek approval for our product candidates. The process of obtaining regulatory approvals of drugs for therapeutic
indications or commercialization of non-drug products and ensuring subsequent compliance with appropriate federal, state, local and foreign statutes and
regulations requires the expenditure of substantial time and financial resources.
16
In the United States, the FDA regulates drug products as well as dietary non-drug products such as foods under the Federal Food, Drug and Cosmetic Act
(“FD&C Act”), its implementing regulations and other laws. At this time none of our MMTs have been approved by the FDA for marketing for therapeutic
indications in the United States or been authorized for use as a food or medical food. If we fail to comply with applicable FDA or other requirements at any
time during product development, clinical testing, the approval process or after approval, we may become subject to administrative or judicial sanctions.
These sanctions could include the FDA’s refusal to approve pending applications, issuance of clinical holds for ongoing studies, suspension or revocation of
approved applications, warning or untitled enforcement letters, product recalls, product seizures, total or partial suspensions of manufacturing or
distribution, injunctions, fines, civil penalties or criminal prosecution. Any FDA enforcement action could have a material adverse effect on us.
We anticipate that the process required by FDA for our MMT candidates to be marketed in the United States as drugs for therapeutic indications will
generally involve the following:
•
completion of preclinical studies in accordance with applicable regulations, including studies conducted in accordance with good laboratory
practice (“GLP”) requirements;
•
submission to the FDA of an IND application;
•
performance of adequate and well-controlled human clinical trials in accordance with applicable IND regulations, GCP requirements and
other clinical trial-related regulations, including approval by an IRB or independent ethics committee at each trial site, to establish the safety
and efficacy of the investigational product for each proposed indication;
•
submission to the FDA of a New Drug Application (“NDA”), including payment of user fees and acceptance by the FDA of the NDA;
•
satisfactory completion of one or more FDA pre-approval inspections of the manufacturing facility or facilities where the drug will be
produced to assess compliance with cGMP requirements to assure that the facilities, methods and controls are adequate to preserve the drug’s
identity, strength, quality and purity;
•
potential FDA audit of the clinical trial sites that generated the data in support of the NDA;
•
FDA review and approval of the NDA, including consideration of the views of any FDA advisory committee, prior to any commercial
marketing or sale of the drug in the United States; and
•
compliance with ay post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy
(“REMS”), and the potential requirement to conduct post-approval studies.
The testing and approval process requires substantial time, effort and financial resources, and we cannot be certain that any approvals for our product
candidates will be granted on a timely basis, if at all.
FDA regulation of food uses
To date, we have not elected a product candidate to develop and market as a food and may elect never to do so. If we decide to develop one or more of our
MMTs as a conventional food product, we will have to follow regulations applicable to food uses.
The FDA and other regulatory authorities, including the Federal Trade Commission (“FTC”), regulate the manufacturing, preparation, quality control,
import, export, packaging, labeling, advertising, promotion, distribution, safety, and adverse event reporting of conventional foods. Among other things,
manufacturers of conventional foods and medical foods must meet relevant cGMP, and certain requirements that govern the manufacturing, packaging,
labeling and holding of foods.
17
With certain exceptions, clinical investigations in which an investigational drug is administered to human subjects must be conducted under an IND, as
required by FDA regulations. The FDA has published a guidance document for clinical investigators, sponsors, and IRBs, Investigational New Drug
Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND, that provides the FDA’s thinking on when an
IND is required for human research studies. FDA’s interpretation of its regulations, as articulated in this guidance, do not require human testing of food,
dietary supplements, or GRAS substances to be conducted under an IND unless such testing is intended to evaluate the product’s ability to diagnose, cure,
mitigate, treat, or prevent a disease or condition. FDA specifically recognizes an IND will not be required when a study is designed to “evaluate the
tolerability of a food in a specific susceptible population, including individuals with a disease in a diseased population,” provided the study is not designed
to evaluate the product’s ability to diagnose, cure, mitigate, treat, or prevent a disease or condition. There is no assurance that FDA’s thinking on this matter
will not change, and if it does, FDA may decide to take enforcement action against testing of GRAS substances that it believes should be conducted under
an IND, or the FDA may delay or deny an IND submitted with supporting data from human studies not conducted under an IND, or require alternate or
additional data to support such an IND before authorizing an applicant to proceed.
Additionally, depending on the circumstances, the use of a substance in certain clinical investigations may restrict the marketing of such substance in food.
Section 301(ll) of the FD&C Act prohibits the marketing of any food to which has been added a drug or biologic for which substantial clinical
investigations have been instituted and for which the existence of such investigations has been made public, unless the substance was marketed in food
before any substantial clinical investigations involving the drug or biologic were instituted or one of the other exceptions in section 301(ll) applies.
Marketing the substance of interest in food before seeking an IND or beginning any clinical investigations preserves the option to continue to market the
substance in those forms after substantial clinical investigations have been instituted and their existence has been made public.
The FDA may classify some or all of our potential product candidates as containing a food additive that is not GRAS. Such classification would cause
these product candidates to require pre-market approval for a food additive regulation, which could substantially delay or prevent the commercialization of
these product candidates for non-drug uses. Any delay in the regulatory consultation process, or a determination that any of our drug or food product
candidates do not meet regulatory requirements of FDA, including any applicable GRAS requirements, could cause a delay in the commercialization of our
product candidates, which may lead to reduced acceptance by the public or others or an inability to commercialize those candidates at all.
FDA regulation of medical food uses
In parallel with our development of MMT product candidates for therapeutic indications, we are exploring the development of some of our product
candidates as medical food products. To date, we have not elected a product candidate to develop and market as a medical food and may elect never to do
so.
The FDA and other regulatory authorities, including the FTC also regulate the manufacturing, preparation, quality control, import, export, packaging,
labeling, advertising, promotion, distribution, safety, and adverse event reporting of medical foods. Among other things, manufacturers of medical foods
must meet relevant cGMP and certain requirements that govern the manufacturing, packaging, labeling and holding of foods.
Preclinical and clinical trials for drugs
Once a product candidate is identified for development as a drug, it enters the preclinical testing stage. Preclinical studies include laboratory evaluations of
drug chemistry, formulation and stability, as well as in vitro and animal studies to evaluate the potential for adverse events, which must be conducted in
accordance with federal regulations and requirements, including GLP requirements. The results of the preclinical studies, together with manufacturing
information and analytical data as well as the results of our human clinical studies, are submitted to the FDA as part of an IND. An IND is a request for
authorization from the FDA to administer an investigational product to humans and must become effective before human clinical trials may begin. The
IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises concerns or questions about
the conduct of the clinical trial, including concerns that human research subjects will be exposed to unreasonable health risks, and imposes a clinical hold.
In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. Submission of an IND may result in
the FDA not allowing clinical trials to commence or not allowing clinical trials to commence on the terms originally specified in the IND. A separate
submission to an existing IND must also be made for each successive clinical trial conducted during product development, and the FDA must grant
permission, either explicitly or implicitly by not objecting before each clinical trial can begin.
18
Clinical trials involve the administration of the product candidate to human volunteers under the supervision of qualified investigators. Clinical trials are
conducted under protocols detailing, among other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria and
the parameters and criteria to be used in monitoring safety and evaluating effectiveness. Each protocol for our product candidates for therapeutic
indications must be submitted to the FDA as part of the IND. An IRB for each investigator site proposing to participate in a clinical trial must also review
and approve the clinical trial before it can begin at that site. The FDA’s regulations provide additional safeguards for pediatric subjects enrolled in clinical
trials of investigational products. For example, under the FDA’s regulations, a clinical investigation involving greater than minimal risk to children but that
presents the prospect of direct benefit to individual subjects may involve pediatric subjects only if the IRB finds that the risk is justified by the anticipated
benefit to the subjects, the relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative
approaches, and adequate provisions are made for soliciting the consent of the pediatric subjects and the permission of their parents and guardians. Further,
the IRB must monitor the clinical trial until it is completed. The FDA, the IRB, or the sponsor may suspend or discontinue a clinical trial at any time on
various grounds, including a finding that the subjects are being exposed to an unacceptable health risk. Clinical testing of product candidates for therapeutic
indications also must satisfy extensive GCP requirements, including requirements for informed consent.
Human clinical trials for therapeutic indications are typically conducted in three sequential phases, which may overlap or be combined. In certain
circumstances, where sufficient evidence of safety and tolerability are collected from preclinical studies and other human experience with a product, such
as our human clinical studies, we believe a human clinical trial may begin as late as Phase 3.
•
Phase 1 — Phase 1 clinical trials involve initial introduction of the investigational product into healthy human volunteers or patients with the
target disease or condition. These studies are typically designed to test the safety, dosage tolerance, absorption, metabolism and distribution
of the investigational product in humans, excretion the side effects associated with increasing doses, and, if possible, to gain early evidence
of effectiveness.
•
Phase 2 — Phase 2 clinical trials typically involve administration of the investigational product to a limited patient population with a
specified disease or condition to evaluate the preliminary efficacy, optimal dosages and dosing schedule and to identify possible adverse side
effects and safety risks.
•
Phase 3 — Phase 3 clinical trials typically involve administration of the investigational product to an expanded patient population to further
evaluate dosage, to provide statistically significant evidence of clinical efficacy and to further test for safety, generally at multiple
geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the investigational
product and to provide an adequate basis for product approval and physician labeling.
Orphan Drug Designation
Under the Orphan Drug Act, the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition, which is a disease or
condition that affects fewer than 200,000 individuals in the United States, or if it affects more than 200,000 individuals in the United States, there is no
reasonable expectation that the cost of developing and making the product available in the United States for the disease or condition will be recovered from
sales of the product. Orphan designation must be requested before submitting an NDA or a Biologics License Application. Orphan designation does not
convey any advantage in or shorten the duration of the regulatory review and approval process, though companies developing orphan products are eligible
for certain incentives, including tax credits for qualified clinical testing and waiver of application fees.
If a product that has orphan designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the
product is entitled to a seven-year period of marketing exclusivity during which the FDA may not approve any other applications to market the same
therapeutic agent for the same indication, except in limited circumstances, such as a subsequent product’s showing of clinical superiority over the product
with orphan exclusivity or where the original applicant cannot produce sufficient quantities of product. Competitors, however, may receive approval of
different therapeutic agents for the indication for which the orphan product has exclusivity or obtain approval for the same therapeutic agent for a different
indication than that for which the orphan product has exclusivity. Orphan product exclusivity could block the approval of one of our products for seven
years if a competitor obtains approval for the same therapeutic agent for the same indication before we do, unless we are able to demonstrate that our
product is clinically superior. Furthermore, if a designated orphan product receives marketing approval for an indication broader than the rare disease or
condition for which it received orphan designation, it may not be entitled to orphan exclusivity.
19
Expedited development and review programs for drugs
The FDA maintains several programs intended to facilitate and expedite development and review of new drugs and biologics to address unmet medical
needs in the treatment of serious or life- threatening diseases or conditions. These programs include Fast Track designation, Breakthrough Therapy
designation, Priority Review and Accelerated Approval, and the purpose of these programs is to either expedite the development or review of important
new drugs to get them to patients earlier than under standard FDA development and review procedures.
A new drug or biologic is eligible for Fast Track designation if it is intended to treat a serious or life-threatening disease or condition and demonstrates the
potential to address unmet medical needs for such disease or condition. Fast Track designation provides increased opportunities for sponsor interactions
with the FDA during preclinical and clinical development, in addition to the potential for rolling review once a marketing application is filed, meaning that
the agency may review portions of the marketing application before the sponsor submits the complete application, as well as Priority Review, discussed
below. In addition, a new drug or biologic may be eligible for Breakthrough Therapy designation if it is intended to treat a serious or life-threatening
disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or
more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. Breakthrough Therapy designation
provides all the features of Fast Track designation in addition to intensive guidance on an efficient drug development program beginning as early as Phase
1, and FDA organizational commitment to expedited development, including involvement of senior managers and experienced review staff in a cross-
disciplinary review, where appropriate.
Any product submitted to the FDA for approval, including a product with Fast Track or Breakthrough Therapy designation, may also be eligible for
additional FDA programs intended to expedite the review and approval process, including Priority Review designation and accelerated approval. A product
is eligible for Priority Review if it has the potential to provide a significant improvement in safety or effectiveness in the treatment, diagnosis or prevention
of a serious disease or condition. Under Priority Review, FDA must review an application in six months compared to ten months for a standard review.
Additionally, products are eligible for accelerated approval if they can be shown to have an effect on a surrogate endpoint that is reasonably likely to
predict clinical benefit, or an effect on a clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality which is
reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of
the condition and the availability or lack of alternative treatments.
Accelerated approval is usually contingent on a sponsor’s agreement to conduct additional post-approval studies to verify and describe the product’s
clinical benefit. In addition, unless otherwise informed by the FDA, the FDA currently requires, as a condition for accelerated approval, that all advertising
and promotional materials that are intended for dissemination or publication within 120 days following marketing approval be submitted to the agency for
review during the pre-approval review period, and that after 120 days following marketing approval, all advertising and promotional materials must be
submitted at least 30 days prior to the intended time of initial dissemination or publication.
Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or
the time period for FDA review or approval may not be shortened. Furthermore, Fast Track designation, Breakthrough Therapy designation, Priority
Review and Accelerated Approval do not change the standards for approval but may expedite the development or review process.
U.S. marketing approval for drugs
Assuming successful completion of the required clinical testing of our product candidates for drug uses, the results of the preclinical and clinical studies,
together with detailed information relating to the product’s chemistry, manufacture, controls and proposed labeling, among other things, are submitted to
the FDA as part of an NDA requesting approval to market the product for one or more indications. In most cases, the submission of an NDA is subject to a
substantial application user fee. An NDA is a request for approval to market a new drug for one or more specified indications and must contain proof of the
drug’s safety and efficacy. To support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety and efficacy
of the investigational product to the satisfaction of the FDA. FDA approval of an NDA must be obtained before a drug may be marketed in the United
States.
20
In addition, under the Pediatric Research Equity Act of 2003, as amended and reauthorized, certain NDAs or supplements to an NDA must contain data
that are adequate to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations, and to support dosing
and administration for each pediatric subpopulation for which the product is safe and effective. The FDA may, on its own initiative or at the request of the
applicant, grant deferrals for submission of some or all pediatric data until after approval of the product for use in adults, or full or partial waivers from the
pediatric data requirements. An Agreed Initial Pediatric Study Plan requesting a waiver from the requirement to conduct clinical studies has been submitted
to the FDA.
Before approving an NDA, the FDA typically will inspect the facility or facilities where the product is manufactured. The FDA will not approve an
application unless it determines that the manufacturing processes and facilities are compliant with cGMP requirements and adequate to assure consistent
production of the Sponsor product within required specifications. Additionally, before approving an NDA, the FDA may inspect one or more clinical trial
sites to assure compliance with GCP and other requirements and the integrity of the clinical data submitted to the FDA.
After evaluating the NDA and all related information, including any inspection reports regarding the manufacturing facilities and clinical trial sites, the
FDA may issue an approval letter, or, in some cases, a complete response letter. A complete response letter generally contains a statement of specific
conditions that must be met in order to secure final approval of the NDA and may require additional clinical or preclinical testing in order for FDA to
reconsider the application. Even with submission of this additional information, the FDA ultimately may decide that the application does not satisfy the
regulatory criteria for approval. If and when those conditions have been met to the FDA’s satisfaction, the FDA will typically issue an approval letter. An
approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications.
Even if the FDA approves a product, depending on the specific risk(s) to be addressed it may limit the approved indications for use of the product, require
that contraindications, warnings or precautions be included in the product labeling, require that post-approval studies, including Phase 4 clinical trials, be
conducted to further assess a drug’s safety after approval, require testing and surveillance programs to monitor the product after commercialization, or
impose other conditions, including distribution and use restrictions or other risk management mechanisms under a REMS, which can materially affect the
potential market and profitability of the product. The FDA may prevent or limit further marketing of a product based on the results of post-marketing
studies or surveillance programs. After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes,
and additional labeling claims, are subject to further testing requirements and FDA review and approval.
U.S. post-approval requirements for drugs
Drugs manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other
things, requirements relating to recordkeeping, periodic reporting, product sampling and distribution, advertising and promotion and reporting of adverse
experiences with the product. There is also a continuing, annual prescription drug product program user fee.
The FDA may impose a number of post-approval requirements as a condition of approval of an NDA. For example, the FDA may require post-market
testing, including Phase 4 clinical trials, and surveillance to further assess and monitor the product’s safety and effectiveness after commercialization.
In addition, drug manufacturers and their subcontractors involved in the manufacture and distribution of approved drugs are required to register their
establishments with the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA and certain state agencies for
compliance with ongoing regulatory requirements, including cGMP, which impose certain procedural and documentation requirements upon us and our
contract manufacturers. Failure to comply with statutory and regulatory requirements can subject a manufacturer to possible legal or regulatory action, such
as warning letters, suspension of manufacturing, product seizures, injunctions, civil penalties or criminal prosecution.
Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing
processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information, requirements
for post-market studies or clinical trials to assess new safety risks, or imposition of distribution or other potential consequences up to and including
revocation of product approvals.
21
Other regulatory matters
Manufacturing, sales, promotion and other activities following product approval or commercialization are also subject to regulation by numerous regulatory
authorities in the United States in addition to the FDA, including the Centers for Medicare & Medicaid Services, other divisions of the Department of
Health and Human Services, the Department of Justice, the Drug Enforcement Administration, the Consumer Product Safety Commission, the FTC, the
Occupational Safety & Health Administration, the Environmental Protection Agency and state and local governments and governmental agencies.
Packaging and distribution in the United States
If our products are made available to authorized users of the Federal Supply Schedule of the General Services Administration, additional laws and
requirements apply. Products must meet applicable child-resistant packaging requirements under the U.S. Poison Prevention Packaging Act.
Manufacturing, sales, promotion and other activities also are potentially subject to federal and state consumer protection and unfair competition laws.
The distribution of pharmaceutical products is subject to additional requirements and regulations, including extensive record-keeping, licensing, storage
and security requirements intended to prevent the unauthorized sale of pharmaceutical products.
Changes in regulations, statutes or the interpretation of existing regulations could impact our business in the future by requiring, for example: (i) changes to
our manufacturing arrangements; (ii) additions or modifications to product labeling; (iii) the recall or discontinuation of our products; or (iv) additional
record-keeping requirements. If any such changes were to be imposed, they could adversely affect the operation of our business.
Other U.S. environmental, health and safety laws and regulations
We may be subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling,
use, storage, treatment and disposal of hazardous materials and wastes. From time to time and in the future, our operations may involve the use of
hazardous and flammable materials, including chemicals and biological materials, and may also produce hazardous waste products. Even if we contract
with third parties for the disposal of these materials and waste products, we cannot completely eliminate the risk of contamination or injury resulting from
these materials. In the event of contamination or injury resulting from the use or disposal of our hazardous materials, we could be held liable for any
resulting damages, and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties
for failure to comply with such laws and regulations.
We maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees, but this insurance may
not provide adequate coverage against potential liabilities. However, we do not maintain insurance for environmental liability or toxic tort claims that may
be asserted against us.
In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. Current or
future environmental laws and regulations may impair our research, development or production efforts. In addition, failure to comply with these laws and
regulations may result in substantial fines, penalties or other sanctions.
Coverage and Reimbursement
In the United States and markets in other countries, patients generally rely on third-party payors to reimburse all or part of the costs associated with their
treatment. Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which medications
they will pay for and establish reimbursement levels. In the United States, the principal decisions about reimbursement for new medicines are typically
made by CMS. CMS decides whether and to what extent a new medicine will be covered and reimbursed under Medicare and private payors tend to follow
CMS to a substantial degree. Factors that payors consider in determining reimbursement are based on whether the product is:
•
a covered benefit under its health plan;
22
•
safe, effective and medically necessary;
•
appropriate for the specific patient;
•
cost-effective; and
•
neither experimental nor investigational.
The requirements governing drug pricing vary widely from country to country. For example, the European Union provides options for its Member States to
restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal
products for human use. To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical trials that compare
the cost effectiveness of a particular product candidate to currently available therapies. A Member State may approve a specific price for the medicinal
product or it may instead adopt a system of direct or indirect controls on the profitability of the Company placing the medicinal product on the market.
Historically, products launched in the European Union do not follow price structures of the U.S. and generally prices tend to be significantly lower.
Other Healthcare and Privacy Laws
Healthcare providers, physicians, and third-party payors will play a primary role in the recommendation and prescription of any products for which we
obtain marketing approval. Our business operations and any current or future arrangements with third-party payors, healthcare providers and physicians
may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements
and relationships through which we develop, market, sell and distribute any drugs for which we obtain marketing approval. In the United States, these laws
include, without limitation, state and federal anti-kickback, false claims, physician transparency, and patient data privacy and security laws and regulations,
including but not limited to those described below.
•
The Anti-Kickback Statute prohibits for any person, including a prescription drug manufacturer (or a party acting on its behalf), to knowingly
and willfully solicit, receive, offer, provide or pay any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, that is
intended to induce or reward referrals, including the purchase, recommendation, order, arrangement or prescription of a good or service, for
which payment may be made under a federal healthcare program, such as Medicare or Medicaid. The term “remuneration” has been broadly
interpreted to include anything of value. Violations of this law are punishable by imprisonment, criminal fines, administrative civil money
penalties and exclusion from participation in federal healthcare programs. In addition, a person or entity does not need to have actual
knowledge of the statute or specific intent to violate it. This statute has been interpreted to apply to arrangements between pharmaceutical
manufacturers on the one hand, and prescribers, purchasers and formulary managers, among others, on the other. In addition, the government
may assert that a claim including items or services resulting from a violation of the Anti-Kickback Statute constitutes a false or fraudulent
claim for purposes of the federal civil False Claims Act or federal civil money penalties statute.
•
Federal civil and criminal false claims laws, and civil monetary penalty laws including the federal False Claims Act, which imposes civil
penalties, including through civil whistleblower or qui tam actions, against individuals or entities (including manufacturers) for, among other
things, knowingly presenting, or causing to be presented false, fictitious, or fraudulent claims for payment by a federal healthcare program; or
knowingly making a false statement or record material to payment of a false or fraudulent claim or obligation to pay or transmit money or
property to the federal government; or knowingly and improperly avoiding, decreasing or knowingly concealing an obligation to pay money
to the federal government. The government may deem manufacturers to have “caused” the submission of false or fraudulent claims by, for
example, providing inaccurate billing or coding information to customers, with respect to drug products, purportedly concealing price
concessions in the pricing information submitted to the government for government price reporting purposes, allegedly providing free
product to customers with the expectation that the customers would bill federal healthcare programs for the product, or promoting a product
off-label. Claims that include items or services resulting from a violation of the federal Anti-Kickback Statute are false or fraudulent claims
for purposes of the False
23
Claims Act. Any future marketing and activities relating to the reporting of wholesaler or estimated retail prices for drug products, the
reporting of prices used to calculate Medicaid rebate information and other information affecting federal, state and third-party reimbursement
for our products, and the sale and marketing of our product and any future product candidates, are subject to scrutiny under this law.
•
The Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal and civil liability for knowingly and willfully
executing a scheme, or attempting to execute a scheme, to defraud any healthcare benefit program, including private payors, knowingly and
willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, or
knowingly and willfully falsifying, concealing or covering up by trick or device a material fact or making any materially false statements in
connection with the delivery of or payment for healthcare benefits, items or services. Similar to the federal Anti-Kickback Statute, a person
or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.
•
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective
implementing regulations, including the Final Omnibus Rules published January 2013, imposes, among other things, specified requirements
on covered entities and their business associates relating to the privacy, security and transmission of individually identifiable health
information including mandatory contractual terms and required implementation of technical safeguards of such information. HITECH also
created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates
in some cases, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the
federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions.
•
The Physician Payments Sunshine Act, enacted as part of the Patient Protection and Affordable Care Act, as amended by the Health Care and
Education Reconciliation Act of 2010, or collectively, the ACA, imposed new annual reporting requirements for certain manufacturers of
drugs, devices, biologics, and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance
Program, for information related to certain payments and “transfers of value” provided to physicians (defined to include doctors, dentists,
optometrists, podiatrists and chiropractors) and teaching hospitals, as well as ownership and investment interests held by physicians and their
immediate family members. Effective January 1, 2022, these reporting obligations extend to include transfers of value made to certain non-
physician providers such as physician assistants and nurse practitioners.
•
Federal government price reporting laws, which require us to calculate and report complex pricing metrics in an accurate and timely manner
to government programs.
•
Federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm
consumers.
•
Analogous state and foreign fraud and abuse laws and regulations, such as state anti-kickback and false claims laws, which may be broader in
scope and apply regardless of payor. These laws are enforced by various state agencies and through private actions. Some state laws require
pharmaceutical companies implement compliance to comply with the pharmaceutical industry’s voluntary compliance guidelines and the
relevant federal government compliance guidance, require drug manufacturers to report information related to payments and other transfers
of value to physicians and other healthcare providers, and restrict marketing practices or require disclosure of marketing expenditures and
pricing information. State and foreign laws also govern the privacy and security of health information in some circumstances. These data
privacy and security laws may differ from each other in significant ways and often are not pre-empted by HIPAA, which may complicate
compliance efforts. Data privacy and security laws and regulations in foreign jurisdictions may also be more stringent than those in the
United States (such as the European Union, which adopted the General Data Protection Regulation, which became effective in May 2018).
24
Current and Future Healthcare Reform Legislation
In both the United States and certain foreign jurisdictions, there have been a number of legislative and regulatory changes to the healthcare system. In
particular, in 2010 the ACA was enacted, which, among other things, subjected biologic products to potential competition by lower-cost biosimilars;
addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled,
infused, instilled, implanted or injected; increased the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program;
extended the Medicaid Drug Rebate program to utilization of prescriptions of individuals enrolled in Medicaid managed care organizations; subjected
manufacturers to new annual fees and taxes for certain branded prescription drugs; created a new Medicare Part D coverage gap discount program, in
which manufacturers must agree to offer 50% (increased to 70% pursuant to the Bipartisan Budget Act of 2018, effective as of January 1, 2019) point-of-
sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the
manufacturer’s outpatient drugs to be covered under Medicare Part D; and provided incentives to programs that increase the federal government’s
comparative effectiveness research.
Since its enactment, there have been judicial, Congressional and executive challenges to certain aspects of the ACA. On June 17, 2021, the U.S. Supreme
Court dismissed the most recent judicial challenge to the ACA brought by several states without specifically ruling on the constitutionality of the ACA.
Prior to the Supreme Court’s decision, President Biden issued an executive order to initiate a special enrollment period from February 15, 2021 through
August 15, 2021 for purposes of obtaining health insurance coverage through the ACA marketplace. The executive order also instructed certain
governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining
Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to
health insurance coverage through Medicaid or the ACA. It is unclear how other healthcare reform measures of the Biden administration or other efforts, if
any, to challenge, repeal or replace the ACA will impact our business.
The Bipartisan Budget Act of 2018 also amends the ACA, effective January 1, 2019, by increasing the point-of-sale discount that is owed by
pharmaceutical manufacturers who participate in Medicare Part D and closing the coverage gap in most Medicare drug plans, commonly referred to as the
“donut hole,” which will shift costs for name brand drugs away from Part D participants back to the manufacturers, which could have a negative effect on
our profits in the event any of our products receive FDA approval and CMS reimbursement. Similarly, CMS recently proposed regulations that would give
states greater flexibility in setting benchmarks for insurers in the individual and small group marketplaces, which may have the effect of relaxing the
essential health benefits required under the ACA for plans sold through such marketplaces. Additionally, CMS has finalized a rule that would amend the
Medicare Advantage and Medicare Part D prescription drug benefit regulations to reduce out of pocket costs for plan enrollees and allow Medicare plans to
negotiate lower rates for certain drugs. In May 2019, CMS issued a final rule to allow Medicare Advantage Plans the option of using step therapy, a type of
prior authorization, for Part B drugs beginning January 1, 2020. This final rule codified CMS’s policy change that was became effective January 1, 2019.
In addition, other legislative and regulatory changes have been proposed and adopted in the United States since the ACA was enacted:
•
On August 2, 2011, the U.S. Budget Control Act of 2011, among other things, included aggregate reductions of Medicare payments to
providers of 2% per fiscal year. These reductions went into effect on April 1, 2013 and, due to subsequent legislative amendments to the
statute, will remain in effect through 2030, with the exception of a temporary suspension from May 1, 2020 through March 31, 2022 due to
the COVID-19 pandemic. Following the temporary suspension, a 1% payment reduction will occur beginning April 1, 2022 through June 30,
2022, and the 2% payment reduction will resume on July 1, 2022.
•
On January 2, 2013, the U.S. American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced
Medicare payments to several types of providers.
25
•
On April 13, 2017, CMS published a final rule that gives states greater flexibility in setting benchmarks for insurers in the individual and
small group marketplaces, which may have the effect of relaxing the essential health benefits required under the ACA for plans sold through
such marketplaces.
•
On May 30, 2018, the Right to Try Act, was signed into law. The law, among other things, provides a federal framework for certain patients
to access certain investigational new drug products that have completed a Phase 1 clinical trial and that are undergoing investigation for FDA
approval. Under certain circumstances, eligible patients can seek treatment without enrolling in clinical trials and without obtaining FDA
permission under the FDA expanded access program. There is no obligation for a pharmaceutical manufacturer to make its drug products
available to eligible patients as a result of the Right to Try Act.
•
On May 23, 2019, CMS published a final rule to allow Medicare Advantage Plans the option of using step therapy for Part B drugs beginning
January 1, 2020.
On December 20, 2019, former President Trump signed into law the Further Consolidated Appropriations Act (H.R. 1865), which repealed the Cadillac tax,
the health insurance provider tax, and the medical device excise tax. It is impossible to determine whether similar taxes could be instated in the future.
Additionally, there has been increasing legislative and enforcement interest in the United States with respect to drug pricing practices. Specifically, there
has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several
U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug
pricing, reduce the cost of prescription drugs under Medicare, and review the relationship between pricing and manufacturer patient programs. At the
federal level, President Biden signed an Executive Order on July 9, 2021 affirming the administration’s policy to (i) support legislative reforms that would
lower the prices of prescription drug and biologics, including by allowing Medicare to negotiate drug prices, by imposing inflation caps, and, by supporting
the development and market entry of lower-cost generic drugs and biosimilars; and (ii) support the enactment of a public health insurance option. Among
other things, the Executive Order also directs HHS to provide a report on actions to combat excessive pricing of prescription drugs, enhance the domestic
drug supply chain, reduce the price that the Federal government pays for drugs, and address price gouging in the industry; and directs the FDA to work
with states and Indian Tribes that propose to develop section 804 Importation Programs in accordance with the Medicare Prescription Drug, Improvement,
and Modernization Act of 2003, and the FDA’s implementing regulations. FDA released such implementing regulations on September 24, 2020, which
went into effect on November 30, 2020, providing guidance for states to build and submit importation plans for drugs from Canada. On September 25,
2020, CMS stated drugs imported by states under this rule will not be eligible for federal rebates under Section 1927 of the Social Security Act and
manufacturers would not report these drugs for “best price” or Average Manufacturer Price purposes. Since these drugs are not considered covered
outpatient drugs, CMS further stated it will not publish a National Average Drug Acquisition Cost for these drugs. If implemented, importation of drugs
from Canada may materially and adversely affect the price we receive for any of our product candidates. Further, on November 20, 2020 CMS issued an
Interim Final Rule implementing the Most Favored Nation, or MFN, Model under which Medicare Part B reimbursement rates would have been be
calculated for certain drugs and biologicals based on the lowest price drug manufacturers receive in Organization for Economic Cooperation and
Development countries with a similar gross domestic product per capita. However, on December 29, 2021 CMS rescinded the Most Favored Nations rule.
Additionally, on November 30, 2020, HHS published a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers
to plan sponsors under Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law. The rule also creates a
new safe harbor for price reductions reflected at the point-of-sale, as well as a safe harbor for certain fixed fee arrangements between pharmacy benefit
managers and manufacturers. Pursuant to court order, the removal and addition of the aforementioned safe harbors were delayed and recent legislation
imposed a moratorium on implementation of the rule until January 1, 2026. Although a number of these and other proposed measures may require
authorization through additional legislation to become effective, and the Biden administration may reverse or otherwise change these measures, both the
Biden administration and Congress have indicated that they will continue to seek new legislative measures to control drug costs.
Individual states in the United States have also become increasingly active in passing legislation and implementing regulations designed to control
pharmaceutical and biological product pricing, including price or patient
26
reimbursement constraints, discounts, restrictions on certain drug access and marketing cost disclosure and transparency measures, and designed to
encourage importation from other countries and bulk purchasing. Legally mandated price controls on payment amounts by third-party payors or other
restrictions could harm our business, financial condition, results of operations and prospects. In addition, regional healthcare authorities and individual
hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription
drug and other healthcare programs. This could reduce the ultimate demand for our drugs or put pressure on our drug pricing, which could negatively affect
our business, financial condition, results of operations and prospects.
Government regulation of drugs outside of the United States
To market any product outside of the United States, we would need to comply with numerous and varying regulatory requirements of other countries
regarding safety and efficacy and governing, among other things, clinical trials, marketing authorization or identification of an alternate regulatory pathway,
manufacturing, commercial sales and distribution of our products. For instance, in the European Economic Area (“EEA”) medicinal products must be
authorized for marketing by using either the centralized authorization procedure or national authorization procedures.
•
Centralized procedure — If pursuing marketing authorization of a product candidate for a therapeutic indication under the centralized
procedure, following the opining of the EMA’s Committee for Medicinal Products for Human Use (“CHMP”), the European Commission
issues a single marketing authorization valid across the EEA. The centralized procedure is compulsory for human medicines derived from
biotechnology processes or advanced therapy medicinal products (such as gene therapy, somatic cell therapy and tissue engineered products),
products that contain a new active substance indicated for the treatment of certain diseases, such as HIV/AIDS, cancer, neurodegenerative
disorders, diabetes, autoimmune diseases and other immune dysfunctions, viral diseases, and officially designated orphan medicines. For
medicines that do not fall within these categories, an applicant has the option of submitting an application for a centralized marketing
authorization to the EMA, as long as the medicine concerned contains a new active substance not yet authorized in the EEA, is a significant
therapeutic, scientific or technical innovation, or if its authorization would be in the interest of public health in the EEA. Under the
centralized procedure the maximum timeframe for the evaluation of an MAA by the EMA is 210 days, excluding clock stops, when
additional written or oral information is to be provided by the applicant in response to questions asked by the CHMP. Accelerated assessment
might be granted by the CHMP in exceptional cases, when a medicinal product is expected to be of a major public health interest, particularly
from the point of view of therapeutic innovation. The timeframe for the evaluation of an MAA under the accelerated assessment procedure is
150 days, excluding clock stops.
•
National authorization procedures — There are also two other possible routes to authorize products for therapeutic indications in several
countries, which are available for products that fall outside the scope of the centralized procedure:
•
Decentralized procedure — Using the decentralized procedure, an applicant may apply for simultaneous authorization in more than one EU
country of medicinal products that have not yet been authorized in any EU country and that do not fall within the mandatory scope of the
centralized procedure.
•
Mutual recognition procedure — In the mutual recognition procedure, a medicine is first authorized in one EU Member State, in accordance
with the national procedures of that country. Following this, additional marketing authorizations can be sought from other EU countries in a
procedure whereby the countries concerned recognize the validity of the original, national marketing authorization.
The Clinical Trials Directive 2001/20/EC, the Directive 2005/28/EC on GCP and the related national implementing provisions of the individual EU
Member States govern the system for the approval of clinical trials in the European Union. Under this system, an applicant must obtain prior approval from
the competent national authority of the EU Member States in which the clinical trial is to be conducted. Furthermore, the applicant may only start a clinical
trial at a specific study site after the competent ethics committee has issued a favorable opinion. The CTA must be accompanied by, among other
documents, an investigational medicinal product dossier (the Common Technical Document) with supporting information prescribed by Directive
2001/20/EC, Directive 2005/28/EC, where relevant
27
the implementing national provisions of the individual EU Member States and further detailed in applicable guidance documents.
The collection and use of personal health data in the European Union, previously governed by the provisions of the Data Protection Directive, is now
governed by the General Data Protection Regulation (“GDPR”), which became effective on May 25, 2018. While the Data Protection Directive did not
apply to organizations based outside the EU, the GDPR has expanded its reach to include any business, regardless of its location, that provides goods or
services to residents in the EU. This expansion would incorporate any clinical trial activities in EU member states. The GDPR imposes strict requirements
on controllers and processors of personal data, including special protections for “sensitive information” which includes health and genetic information of
data subjects residing in the EU. GDPR grants individuals the opportunity to object to the processing of their personal information, allows them to request
deletion of personal information in certain circumstances, and provides the individual with an express right to seek legal remedies in the event the
individual believes his or her rights have been violated. Further, the GDPR imposes strict rules on the transfer of personal data out of the European Union
to the United States or other regions that have not been deemed to offer “adequate” privacy protections. Failure to comply with the requirements of the
GDPR and the related national data protection laws of the European Union Member States, which may deviate slightly from the GDPR, may result in fines
of up to 4% of global revenues, or €20,000,000, whichever is greater. As a result of the implementation of the GDPR, we may be required to put in place
additional mechanisms ensuring compliance with the new data protection rules.
There is significant uncertainty related to the manner in which data protection authorities will seek to enforce compliance with GDPR. For example, it is
not clear if the authorities will conduct random audits of companies doing business in the EU, or if the authorities will wait for complaints to be filed by
individuals who claim their rights have been violated. Enforcement uncertainty and the costs associated with ensuring GDPR compliance are onerous and
may adversely affect our business, financial condition, results of operations and prospects.
Additionally, should we elect one or more product candidates to develop and market as non-therapeutic dietary non-drug products or food products in
foreign countries, such products would also be subject to regulation under various national, local, and international laws that include provision governing,
among other things, the formulation, manufacturing, packaging, labeling, advertising. These regulations may prevent or delay entry into the market or
prevent or delay the introduction, or require the reformulation, of certain of our non-therapeutic product candidates.
The regulatory environment outside the United States varies and in general is less developed then in the United States, but some exceptions do exist. The
regulatory requirements for nutritional non-drug products and food products outside of the United States varies greatly from jurisdiction to jurisdiction.
Each jurisdiction may have its own regulatory framework regarding nutritional non-drug products and food products. The two leading jurisdictions, the
United States and the Europe, currently have and may continue to in the future to have distinctly different regulatory regimes with different rules and
requirements nutritional non-drug products and food products, with, for example, the European Union having a stronger process for claims review and
preapproval for nutritional products. Regulation in Europe is exercised primarily through the European Union, which regulates the combined market of
each of its member states. Other European countries, such as Switzerland, have voluntarily adopted laws and regulations that mirror those of the European
Union with respect to dietary products.
We cannot predict how the global regulatory landscape regarding our possible nutritional non-drug products or food products, if any, will evolve and we
may incur increased regulatory costs as regulations in the jurisdictions in which we operate evolve or change. We cannot predict whether or when any
jurisdiction will change its regulations with respect to any of our product candidates.
Should we utilize third part distributors, compliance with such foreign governmental regulations would generally be the responsibility of such distributors,
who may be independent contractors over whom we have limited control.
Government regulation of food for special medical purpose in the European Union
The regulatory requirements for foods for special medical purposes (“FSMPs”), in the European Union cover FSMP development and commercialization.
In the European Union, FSMPs are designed to feed patients who, because of a particular disease, disorder or medical condition, have nutritional needs that
cannot be met by consuming standard foodstuffs. European Union Regulation defines ‘ food for special medical purposes ’ as food specially processed or
formulated and intended for
28
the dietary management of patients, including infants, to be used under medical supervision; it is intended for the exclusive or partial feeding of patients
with a limited, impaired or disturbed capacity to take, digest, absorb, metabolize or excrete ordinary food or certain nutrients contained therein, or
metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved by modification of the normal diet
alone.
Businesses intending to commercialize FSMPs in the European Union are required to register their FSMPs by submitting notifications regarding FSMP
use, demonstrating compliance with applicable European Union rules, prior to market commercialization. These notifications to competent authority of
each European Union Member State include information appearing on the label, and any other information the competent authority may reasonably request
to establish compliance with this Regulation.
The European Commission may decide, by means of implementing acts (a) whether a given food falls within the scope of this Regulation; and (b) to which
specific category of food a given food belongs. European Food Safety Authority Guidance provides, among other requirements, that the dossier must
include an explanation of the scientific and medical basis on which it has been concluded that the use of the specific food product is necessary or is more
practical or safer than the exclusive use of non-FSMP foodstuffs.
FSMPs can also fall within the scope of the novel food legislation in the European Union. Where an ingredient used in the FSMP to be marketed in the
European Union falls within the definition of a ‘novel food ingredient’ prior authorization for use of the ingredient needs to be sought. A “novel” food or
food ingredients as food that has not been consumed to a significant degree by humans in the European Union before May 15, 1997 and that falls within
one of the ten food categories listed. Novel foods and novel food ingredients can only be authorized if they do not pose a safety risk to human health, their
intended use does not mislead the consumer and they do not differ from the food they are intended to replace in such a way that its normal consumption
would be nutritionally disadvantageous for the consumer. The authorization procedure is likely to take between 12 and 18 months.
In accordance with European Union clinical trials directives, before a clinical trial site is allowed to start enrolling patients in a clinical trial, the IRB or
(IEC), must provide a positive opinion concerning the study protocol and all study-related materials. The competent authorities of the relevant European
Union Member State must also provide their related authorization. Clinical trials involving the investigation of the action of non-medicinal products (e.g.
foods, such as many FSMPs), are not covered and are not required to register the clinical trial or to complete a CTA for approval by an European Union
Member State.
Human Capital
As of December 31, 2021, we had 76 full-time employees, of which 25 have Ph.D. or M.D. degrees and 58 were engaged in research and clinical
development activities. The remaining employees were engaged in business development, finance, information systems, facilities, human resources, legal
functions, or administrative support. We also engage consultants and temporary workers when needed. The majority of our employees were based in
Lexington, MA. No employees were represented by labor unions or subject to collective bargaining agreements. We consider our relationships with our
employees to be very strong.
We believe our employees are among the company’s most important assets and are key to achieving our goals and expectations. Our human capital
resource priorities and our competitive equity and cash compensation and benefits programs focus on attracting, recruiting, retaining and incentivizing our
existing and new employees. We consider our human capital resources strategy to be comprehensive and we foster a strong relationship with and among
our employees with ongoing efforts such as employee surveys, training and development programs, social interactions, and other programs.
We are committed to developing policies that promote awareness and behaviors to ensure fair treatment and equality of opportunity, building a culture of
diversity and inclusion, and proactively addressing inequality. In line with our core value of collaboration as noted above, we strive to foster an inclusive
culture and actively seek diverse perspectives as we believe diverse experiences and expertise enriches our way of thinking and is essential to achieving our
goals. This includes policies and practices that uphold these principles throughout the sourcing, hiring, compensation and assessment of candidates and the
retention of our employees.
29
In response to the COVID-19 pandemic and as part of our commitment to ensure the safety and well-being of our employees, we created an internal team
focused on implementing policies and practices consistent with US Government, Massachusetts, and industry standard regulation and guidance in response
to the public health emergency. Since mid-March 2020, the majority of our employees have been working from home. Additionally, we put appropriate
safety measures in place, including implementing occupancy limits, restricting business travel, providing and requiring the use of personal protective
equipment, health screening, cleaning and visitor protocols, and, in cases of possible exposure, external COVID-19 testing to access our workplaces.
Facilities
Our corporate headquarters are located in Lexington, Massachusetts, where we currently lease 107,000 square feet of laboratory and office space. The lease
expires in February 2029, subject to one option to extend the lease for 10 years.
Legal proceedings
We are not currently a party to any material legal proceedings.
Corporate Information
We were incorporated in January 2015 as VL32, Inc. under the laws of the State of Delaware. In November 2015, we changed our name to Kaleido
Biosciences, Inc. Our principal executive office is located at 65 Hayden Avenue, Lexington, Massachusetts, and our telephone number is (617) 674-9000.
Our website address is www.kaleido.com. Our website and the information contained on, or that can be accessed through, the website will not be deemed to
be incorporated by reference in, and are not considered part of, this Annual Report on Form 10-K. You should not rely on any such information in making
your decision whether to purchase our common stock.
On March 4, 2019, we completed the IPO of our common stock pursuant to which we issued and sold 5,000,000 shares of our common stock at a price to
the public of $15.00 per share. We received aggregate gross proceeds from our IPO of $75.0 million, or aggregate net proceeds of $67.8 million after
deducting underwriting discounts and commissions and other offering costs. None of the underwriting discounts and commissions or offering expenses
were incurred or paid, directly or indirectly, to any of our directors or officers or their associates or to persons owning 10% or more of our common stock or
to any of our affiliates.
On June 4, 2020, we completed a public offering (the “Offering”), pursuant to which we issued and sold 4,750,000 shares of our common stock. We
received aggregate net proceeds received from the offering were $34.4 million, including 185,000 shares exercised on July 1, 2020 for the Underwriters’
option. During the year ended December 31, 2020, we sold 361,299 shares of our common stock under the at-the-market public offering (the "ATM")
which resulted in aggregate net proceeds of $3.4 million after payment of related commissions. In January and February 2021, we sold 309,656 shares of
our common stock under the ATM which resulted in aggregate net proceeds of $4.9 million. As of December 31, 2021, there was $41.5 million available
under the ATM.
On February 8, 2021, we completed a public offering (the “2021 Offering”) including the Underwriters’ overallotment option, pursuant to which we issued
and sold 6,037,500 shares of our common stock for aggregate net proceeds of $65.3 million.
We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012. We will remain an emerging growth company until
the earlier of: (i) the last day of the fiscal year (a) following the fifth anniversary of the completion of the IPO, (b) in which we have total annual gross
revenue of at least $1.07 billion, or (c) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is
held by non-affiliates exceeds $700.0 million as of the prior June 30th, and (ii) the date on which we have issued more than $1.0 billion in non-convertible
debt during the prior three-year period.
30
Financial Information and Segments
The financial information required under this Item 1 is incorporated herein by reference to the section of this Annual Report titled “Part II—Item 8—
Financial Statements and Supplementary Data. The company manages its operations as a single segment for the purposes of assessing performance and
making operating decisions. The company is developing red cell therapeutics for the treatment of patients with severe diseases. All of the company’s
tangible assets are held in the United States. See Note 2 to our consolidated audited financial statements included in this Annual Report on Form 10-K. For
financial information regarding our business, see “Part II—Item 7—Management’s Discussion and Analysis of Financial Condition and Results of
Operations” of this Annual Report on Form 10-K and our consolidated audited financial statements and related notes included elsewhere in this Annual
Report on Form 10-K.
Available Information
Our Internet address is www.kaleido.com. Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, including
exhibits, proxy and information statements and amendments to those reports filed or furnished pursuant to Sections 13(a), 14, and 15(d) of the Securities
Exchange Act of 1934, as amended, or the Exchange Act, are available through the “Investors and Media” portion of our website free of charge as soon as
reasonably practicable after we electronically file such material with, or furnish it to, the SEC. Information on our website is not part of this Annual Report
on Form 10-K or any of our other securities filings unless specifically incorporated herein by reference. Our filings with the SEC may be accessed through
the SEC’s Interactive Data Electronic Applications system at http://www.sec.gov. All statements made in any of our securities filings, including all forward-
looking statements or information, are made as of the date of the document in which the statement is included, and we do not assume or undertake any
obligation to update any of those statements or documents unless we are required to do so by law.
31
Item 1A. Risk Factors.
Our business is subject to numerous risks. You should carefully consider the risks described below, as well as the other information in this Annual Report
on Form 10-K, including our consolidated financial statements and the related notes and “Management’s discussion and analysis of financial condition
and results of operations,” and in our other filings with the Securities and Exchange Commission. The occurrence of any of the events or developments
described below could harm our business, financial condition, results of operations and growth prospects. In such an event, the market price of our
common stock could decline, and you may lose all or part of your investment. Additional risks and uncertainties not presently known to us or that we
currently deem immaterial also may impair our business operations.
Risks Related to Strategic Alternative Process and Potential Strategic Transaction
We may not be successful in identifying and implementing any strategic business combination or other transaction and any strategic transactions that
we may consummate in the future could have negative consequences. If a strategic transaction is not consummated, our Board may decide to pursue a
dissolution and liquidation. In the event of such liquidation or other wind-down event, holders of our securities will likely suffer a total loss of their
investment.
In addition to our efforts, if any, to pursue clinical development of our product candidates, we also continue to evaluate all potential strategic options for the
company, including a merger, reverse merger, sale, wind-down, liquidation and dissolution or other strategic transaction. However, there can be no
assurance that we will be able to successfully consummate any particular strategic transaction. The process of continuing to evaluate these strategic options
may be very costly, time-consuming and complex and we have incurred, and may in the future incur, significant costs related to this continued evaluation,
such as legal and accounting fees and expenses and other related charges. We may also incur additional unanticipated expenses in connection with this
process. A considerable portion of these costs will be incurred regardless of whether any such course of action is implemented or transaction is completed.
Any such expenses will decrease the remaining cash available for use in our business.
There can be no assurances that any particular course of action, business arrangement or transaction, or series of transactions, will be pursued, successfully
consummated, lead to increased stockholder value, or achieve the anticipated results. If we are unable to consummate a strategic transaction, our Board
may decide to pursue a dissolution and liquidation. In the event of such liquidation or other wind-down event, holders of our securities will likely suffer a
total loss of their investment.
We may not realize any additional value in a strategic transaction.
Potential counterparties in a strategic transaction involving our company may place minimal or no value on our assets. Further, the development and any
potential commercialization of our product candidates will require substantial additional cash to fund the costs associated with conducting the necessary
preclinical and clinical testing and obtaining regulatory approval. Consequently, any potential counterparty in a strategic transaction involving our company
may choose not to spend additional resources and continue development of our product candidates and may attribute little or no value, in such a transaction,
to those product candidates.
If we are successful in completing a strategic transaction, we may be exposed to other operational and financial risks.
Although there can be no assurance that a strategic transaction will result from the process we have undertaken to identify and evaluate strategic
alternatives, the negotiation and consummation of any such transaction will require significant time on the part of our management, and the diversion of
management’s attention may disrupt our business.
The negotiation and consummation of any such transaction may also require more time or greater cash resources than we anticipate and expose us to other
operational and financial risks, including:
32
•
increased near-term and long-term expenditures;
•
exposure to unknown liabilities;
•
higher than expected acquisition or integration costs;
•
incurrence of substantial debt or dilutive issuances of equity securities to fund future operations;
•
write-downs of assets or goodwill or incurrence of non-recurring, impairment or other charges;
•
increased amortization expenses;
•
difficulty and cost in combining the operations and personnel of any acquired business with our operations and personnel;
•
impairment of relationships with key suppliers or customers of any acquired business due to changes in management and ownership;
•
inability to retain key employees of our company or any acquired business; and
•
possibility of future litigation.
Any of the foregoing risks could have a material adverse effect on our business, financial condition and prospects.
Our ability to consummate a strategic transaction depends on our ability to retain our employees required to consummate such transaction.
Our ability to consummate a strategic transaction depends upon our ability to retain our employees required to consummate such a transaction, the loss of
whose services may adversely impact the ability to consummate such transaction. In January 2022, we undertook an organizational restructuring that
reduced our workforce in order to conserve our capital resources. Our cash conservation activities may yield unintended consequences, such as attrition
beyond our planned reduction in workforce and reduced employee morale, which may cause remaining employees to seek alternative employment. Our
ability to successfully complete a strategic transaction depends in large part on our ability to retain certain of our remaining personnel. If we are unable to
successfully retain our remaining personnel, we are at risk of a disruption to our exploration and consummation of a strategic alternative as well as business
operations.
The impact and results of our ongoing strategic process are uncertain and may not be successful.
Our board of directors remains dedicated to diligently deliberating upon and making informed decisions that the directors believe are in the best interests of
the company and its stockholders. There can be no assurance, however, that the company’s current strategic direction, or the board’s evaluation of strategic
alternatives, will result in any initiatives, agreements, transactions or plans that will further enhance stockholder value.
In addition, given the substantial restructuring of our operations over the past several years, it may be difficult to evaluate our current business and future
prospects on the basis of historical operating performance.
We may become involved in securities litigation that could divert management’s attention and harm the company’s business, and insurance coverage
may not be sufficient to cover all costs and damages.
In the past, securities litigation has often followed certain significant business transactions, such as the sale of a company or announcement of any other
strategic transaction, or the announcement of negative events, such as negative results from clinical trials. We may be exposed to such litigation even if no
wrongdoing occurred. Litigation is usually expensive and diverts management’s attention and resources, which could adversely affect our business and
cash resources and our ability to consummate a potential strategic transaction or the ultimate value our stockholders receive in any such transaction.
33
Risks related to our business, technology and industry
We have identified conditions and events that raise substantial doubt about our ability to continue as a going concern.
We may be forced to amend, delay, limit, reduce terminate the scope of our development programs and/or limit or cease and wind-down our operations if
we are unable to obtain additional funding. As of December 31, 2021, we had cash and cash equivalents totaling $38.5 million. Based on our current
operating plans, we do not have sufficient cash and cash equivalents to fund our operating expenses and capital expenditures for at least the next 12 months
from the filing date of this Annual Report on Form 10-K. We will require additional capital to sustain our operations, including our development programs.
We expect to seek additional funds through equity or debt financings or through collaborations, licensing transactions or other sources that may be
identified through our strategic process. However, there can be no assurance that we will be able to complete any such transactions on acceptable terms or
otherwise. The failure to obtain sufficient funds on commercially acceptable terms when needed would have a material adverse effect on our business,
results of operations, and financial condition. These factors raise substantial doubt about our ability to continue as a going concern.
The terms of our loan and security agreement with Hercules Capital require us to meet certain operating covenants and place restrictions on our
operating and financial flexibility. If we raise additional capital through debt financing, the terms of any new debt could further restrict our ability to
operate our business.
On December 31, 2019, we entered into a loan and security agreement, or the Loan Agreement, with the several banks and other financial institutions or
entities, or the Lenders, and Hercules Capital, Inc., in its capacity as administrative and collateral agent for itself and the Lenders party to the Loan
Agreement. The loan advanced under the Loan Agreement, or the Term Loan, is secured by a security interest covering our assets, other than our
intellectual property and other customary collateral exclusions. The Loan Agreement contains customary affirmative and negative covenants and events of
default. Affirmative covenants include, among others, covenants requiring us to maintain our legal existence and comply with all applicable laws, deliver
certain financial reports, and maintain insurance coverage. Negative covenants include, among others, covenants restricting us from transferring any part of
our business or intellectual property, incurring additional indebtedness, engaging in mergers or acquisitions, repurchasing shares, paying dividends or
making other distributions, making investments, and creating other liens on our assets, including our intellectual property, in each case subject to customary
exceptions. If we raise any additional debt financing, the terms of such additional debt could further restrict our operating and financial flexibility. These
restrictions may include, among other things, limitations on borrowing and specific restrictions on the use of our assets, as well as prohibitions on our
ability to create liens, pay dividends, redeem capital stock or make investments. If we default under the terms of the Loan Agreement or any future debt
facility, the Lenders may accelerate all of our repayment obligations and take control of our pledged assets, potentially requiring us to renegotiate our
agreement on terms less favorable to us or to immediately cease operations. Further, if we are liquidated, the Lenders’ right to repayment would be senior
to the rights of the holders of our common stock. The Lenders could declare a default upon the occurrence of any event that it interprets as a material
adverse effect as defined under the Loan Agreement. Any declaration by the Lenders of an event of default could significantly harm our business and
prospects and could cause the price of our common stock to decline. If we raise any additional debt financing, the terms of such additional debt could
further restrict our operating and financial flexibility.
Repayment of the amount of the remaining Term Loan will require a significant amount of cash, and we may never have sufficient resources to make
payments on our indebtedness.
Our ability to pay the principal of and/or interest on the Term Loan will require a significant inflow of cash from either operations, financings, or other
strategic transactions. We have no product candidates approved for commercial sale and do not expect to for the foreseeable future. Since we do not expect
to generate any near term cash flow for product sales, in order to repay the Term Loan, we would be required to adopt and implement one or more
alternatives, such as selling assets, restructuring indebtedness or obtaining additional debt financing or equity financing on terms that may be onerous or
highly dilutive. Our ability to refinance the Term Loan or other future indebtedness will depend on the capital markets and our financial condition at such
time. We may not be able to
34
engage in any of these activities or engage in these activities on desirable terms, which could result in a default on our debt obligations, including the Term
Loan.
We have incurred net losses in every year since our inception and anticipate that we will continue to incur net losses in the future.
We are a clinical stage healthcare company with a limited operating history. Investment in product development in the healthcare industry, including of
biopharmaceutical products, is highly speculative because it entails substantial upfront capital expenditures and significant risk that any potential product
candidate will fail to demonstrate adequate effect or an acceptable safety profile, gain regulatory approval, as necessary, and become commercially viable.
Our lead product candidates are currently in clinical development. We have no products approved for commercial sale and have not generated any revenue
from product sales to date, and we continue to incur significant research and development and other expenses related to our ongoing operations. As a result,
we are not profitable and have incurred losses in each period since our inception in 2015. For the years ended December 31, 2021 and 2020, we reported
net losses of $90.3 million and $81.6 million, respectively. As of December 31, 2021, we had an accumulated deficit of $364.5 million. If we are able to
continue as a going concern, we expect to continue to incur significant losses for the foreseeable future, and we expect these losses to increase as we
continue our research and development of, and seek regulatory approvals for, our product candidates.
To become and remain profitable, we or any potential future collaborator must develop and eventually commercialize products with significant market
potential at an adequate profit margin after cost of goods sold and other expenses. This will require us to be successful in a range of challenging activities,
including completing preclinical studies, clinical studies and clinical trials, obtaining marketing approval or identifying alternate regulatory pathways for
product candidates, cGMP manufacturing, marketing and selling products for which we may obtain marketing approval or successfully identify alternate
regulatory pathways and satisfying any post-marketing requirements. We may never succeed in any or all of these activities and, even if we do, we may
never generate revenue that is significant enough to achieve profitability. If we do achieve profitability, we may not be able to sustain or increase
profitability on a quarterly or annual basis.
Even if we succeed in commercializing one or more of our product candidates, we will continue to incur substantial research and development and other
expenditures to develop and market additional product candidates. We may encounter unforeseen expenses, difficulties, complications, delays and other
unknown factors that may adversely affect our business. The size of our future net losses will depend, in part, on the rate of future growth of our expenses
and our ability to generate revenue. Our prior losses and expected future losses have had and will continue to have an adverse effect on our stockholders’
equity and working capital.
We will require additional capital to fund our operations and if we fail to obtain necessary financing, we will not be able to complete the development
and commercialization of our product candidates.
Our operations have consumed substantial amounts of cash since inception. We expect to continue to spend substantial amounts to conduct further research
and development, preclinical studies, clinical studies and clinical trials of our current and future product candidates, to validate the manufacturing process
and establish specifications for our product candidates, to seek regulatory approvals for or identify alternate regulatory pathways to market for our product
candidates and to launch and commercialize any products for which we receive regulatory approval or identify an alternate regulatory pathway to market,
including potentially building our own commercial organization. As of December 31, 2021, we had $38.5 million of cash and cash equivalents on hand.
However, our future capital requirements and the period for which our existing resources will support our operations may vary significantly from what we
expect, and we will in any event require additional capital in order to complete clinical development of any of our current product candidates. Our monthly
spending levels will vary based on new and ongoing development and corporate activities. Because the length of time and activities associated with
development of our product candidates is highly uncertain, we are unable to estimate the actual funds we will require for development and any approved
marketing and commercialization activities.
In addition, as noted above, we have identified conditions and events that raise substantial doubt as to our ability to continue as a going concern if we are
unable to obtain funding on a timely basis. Based on our current operating
35
plans, we do not have sufficient cash and cash equivalents to fund our operating expenses and capital expenditures for at least the next 12 months from the
filing date of this Annual Report.
We do not have any committed external source of funds or other support for our development efforts and we cannot be certain that additional funding will
be available on acceptable terms, or at all. Until we can generate sufficient product or royalty revenue to finance our cash requirements, which we may
never do, we expect to finance our future cash needs through a combination of public or private equity offerings, debt financings, collaborations, strategic
alliances, licensing arrangements and other marketing or distribution arrangements. If we raise additional funds through public or private equity offerings,
the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights. Further, to the extent that we raise
additional capital through the sale of common stock or securities convertible into or exchangeable for common stock, your ownership interest will be
diluted. If we raise additional capital through debt financing, we would be subject to fixed payment obligations and may be subject to covenants limiting or
restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, declaring dividends or acquiring or licensing
intellectual property rights. If we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or
licensing arrangements with third parties, we may have to relinquish certain valuable rights to our product candidates, technologies, future revenue streams
or research programs or grant licenses on terms that may not be favorable to us. We also could be required to seek collaborators for one or more of our
current or future product candidates at an earlier stage than otherwise would be desirable or relinquish our rights to product candidates or technologies that
we otherwise would seek to develop or commercialize ourselves. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to
us, we may have to significantly delay, scale back or discontinue the development or commercialization of one or more of our products or product
candidates or one or more of our other research and development initiatives. Any of the above events could significantly harm our business, prospects,
financial condition and results of operations and cause the price of our common stock to decline.
We have a limited operating history, which may make it difficult to evaluate our technology and product development capabilities and predict our future
performance.
We were formed in 2015, have no products approved for commercial sale or marketed via other regulatory pathways (e.g., non-drug products) and have not
generated any revenue from product sales. Our ability to generate product revenue or profits, which we do not expect will occur for many years, if ever,
will depend on the successful development and eventual commercialization of our product candidates, which may never occur. We may never be able to
develop or commercialize a marketable product.
Our current and future therapeutics programs and product candidates require additional discovery research, preclinical development, clinical development,
regulatory approval in multiple jurisdictions or identification of alternate regulatory pathways to market, manufacturing validation, obtaining cGMP
manufacturing supply, capacity and expertise, building of a commercial and distribution organization, substantial investment and significant marketing
efforts before we generate any revenue from product sales. In addition, our drug product candidates must be approved for marketing by the FDA or certain
other health regulatory agencies, including the EMA, or we must secure alternate non-therapeutic regulatory pathways to market our non-therapeutic
product candidates before we may commercialize any product in the respective jurisdictions.
Our limited operating history may make it difficult to evaluate our technology and industry and predict our future performance. Our short history as an
operating company makes any assessment of our future success or viability subject to significant uncertainty. We will encounter risks and difficulties
frequently experienced by early-stage companies in evolving fields. If we do not address these risks successfully, our business will suffer. Similarly, we
expect that our financial condition and operating results will fluctuate significantly from quarter to quarter and year to year due to a variety of factors, many
of which are beyond our control. As a result, our stockholders should not rely upon the results of any quarterly or annual period as an indicator of future
operating performance.
In addition, as an early-stage company, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown
circumstances. As we advance our product candidates, we will need to transition from a company with a research focus to a company capable of supporting
clinical development and, if successful, commercial activities. We may not be successful in such a transition.
36
Microbiome Metabolic Therapies (“MMT” or “MMTs”) are a novel approach and negative perception of any product candidates that we develop could
adversely affect our ability to conduct our business, obtain regulatory approvals or identify alternate regulatory pathways to market for such product
candidates.
Microbiome therapies and therapy candidates in general, and our MMT candidates in particular, are a relatively new and novel approach. In the United
States and the European Union, no products to date have been approved specifically demonstrating an impact on the microbiome as part of their therapeutic
effect. MMTs and microbiome therapies in general may not be successfully developed or commercialized or gain the acceptance of the public or the
medical community. Our success will depend upon physicians who specialize in the treatment of diseases targeted by our product candidates that we pursue
as drugs, prescribing potential treatments that involve the use of our product candidates in lieu of, or in addition to, existing treatments, if available, with
which they are more familiar and for which greater clinical data may be available. Our access will also depend on consumer acceptance and adoption of our
products that we commercialize. Adverse events in clinical studies and clinical trials of our product candidates or in clinical trials by others developing
similar products and the resulting publicity, as well as any other adverse events in the field of the microbiome, could result in a decrease in demand for any
product that we may develop. In addition, responses by the United States, state or foreign governments to negative public perception or ethical concerns
may result in new legislation or regulations that could limit our ability to develop or commercialize any product candidates, obtain or maintain regulatory
approval, identify alternate regulatory pathways to market or otherwise achieve profitability. More restrictive statutory regimes, government regulations or
negative public opinion would have an adverse effect on our business, financial condition, results of operations and prospects and may delay or impair the
development and commercialization of our product candidates or demand for any products we may develop.
All of our initial product candidates for which we make a drug development path decision, including any targeting ulcerative colitis ("UC") , will
require significant additional preclinical and clinical development before we can seek regulatory approval for and launch a therapeutic product
commercially.
For any product candidate that we choose to develop as a drug product candidate, our business and future success depends on our ability to obtain
regulatory approval of and then successfully launch and commercialize our initial product candidates, KB109 and KB295, as a drug.
We are currently planning for a Phase 2 clinical trial of KB295 focused on ulcerative colitis. While we have completed preclinical work to support the
filing of an IND with the FDA and to file similar clinical trial applications outside of the United States, we have not yet submitted those applications and
there is no surety that they will be accepted if filed. If our applications are submitted and accepted, the ulcerative colitis program will require additional
clinical development, regulatory review and approval in multiple jurisdictions or identification of alternate non-therapeutic regulatory pathways, substantial
investment, access to sufficient validated and cGMP compliant commercial manufacturing capacity and significant marketing efforts before we can
generate any revenue from product sales. In addition, because KB295 is our most advanced product candidate, if KB295 encounters safety, efficacy, supply
or manufacturing problems, developmental delays, regulatory or commercialization issues or other problems, our development plans, including for other
product candidates, and business would be significantly harmed.
The successful development of our product candidates is highly uncertain.
Successful development of product candidates is highly uncertain and is dependent on numerous factors, many of which are beyond our control. Product
candidates that appear promising in the early phases of development may fail to reach the market for several reasons, including:
•
preclinical or clinical study results may show our product candidates to have less activity than desired or to have harmful or problematic side
effects or toxicities;
•
clinical trial results may show our therapeutic product candidates to be less effective than expected or desired (e.g., a clinical trial could fail
to meet its primary endpoint(s)) or to have unacceptable side effects or toxicities;
37
•
failure to execute the clinical studies or clinical trials caused by slow enrollment in clinical studies and clinical trials, patients dropping out of
clinical trials or volunteers dropping out of clinical studies, length of time to achieve clinical trial endpoints, additional time requirements for
data analysis, inability to validate the manufacturing process or to achieve cGMP compliance for our product candidates or inability to
identify a suitable bioanalytical assay method agreeable to our regulators;
•
failure to receive the necessary regulatory approvals or a delay in receiving such approvals for, including but not limited to, a NDA, delays in
NDA preparation, a new dietary ingredient notification, discussions with and responding to the FDA or other regulatory authorities request
for additional preclinical or clinical data or unexpected safety or manufacturing issues;
•
manufacturing costs, formulation issues, manufacturing deficiencies or other factors that make our product candidates uneconomical; and
•
proprietary rights of others and their competing products and technologies that may prevent our product candidates from being
commercialized.
The length of time necessary to complete clinical trials and to submit an application for marketing approval of a drug product candidate for a final decision
by a regulatory authority may be difficult to predict for our therapeutic product candidates, in large part because of their limited regulatory history.
Even if we are successful in obtaining market approval for drug products, commercial success of any approved therapeutic products will also depend in
large part on marketing acceptance, the availability of insurance coverage and adequate reimbursement from third-party payors, including government
payors, such as the Medicare and Medicaid programs, and managed care organizations, which may be affected by existing and future healthcare reform
measures designed to reduce the cost of healthcare.
In addition, if any of our drug product candidates is approved for marketing, we will be subject to significant regulatory obligations regarding the
submission of safety and other post-marketing information and reports and registration. If approved, our drug products would be subject to restrictions on
our products’ labels and other conditions of regulatory approval that may limit our ability to market our products for therapeutic indications. We will also
need to comply (and ensure that our third-party contractors comply) with current cGMPs and Good Clinical Practices (“GCPs”), as we (and our third-party
contractors) will be required to comply with cGMPs for products used in any clinical trials. In addition, we will need to comply with GCPs for any
therapeutic indications we develop for approval and for any additional therapeutic indications we develop after approval of our first drug candidate.
Clinical development is a lengthy and expensive process, with an uncertain outcome. We may incur additional costs or experience delays in completing,
or ultimately be unable to complete, the development and commercialization of any product candidates.
To obtain the requisite regulatory approvals to commercialize any product candidates for therapeutic uses, we must demonstrate through extensive
preclinical studies, clinical studies and clinical trials that our product candidates are safe and effective in humans for their intended use. Clinical testing is
expensive, difficult to design and implement and can take many years to complete, and its outcome is inherently uncertain. We may be unable to establish
clinical endpoints, dose levels and regimens or bioanalytical assay methods that applicable regulatory authorities would consider clinically meaningful, and
a clinical trial can fail at any stage of testing. The outcome of preclinical studies, clinical studies and early clinical trials may not be predictive of the
success of later preclinical studies, clinical studies and clinical trials, and interim results of these studies or trials do not necessarily predict final results.
Differences in trial design between early-stage clinical trials and later-stage clinical trials make it difficult to extrapolate the results of earlier clinical trials
to later clinical trials. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have
believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of
their product candidates.
38
Successful completion of clinical trials is a prerequisite to submitting an NDA to the FDA, a Marketing Authorization Application to the EMA, and similar
marketing applications to comparable other regulatory authorities, for each product candidate for therapeutic indications and, consequently, the ultimate
approval and commercial marketing of any product candidates for therapeutic indications. We do not know whether any of our clinical trials will begin or
be completed on schedule, if at all.
We may experience delays in completing our preclinical studies and initiating or completing clinical studies and clinical trials. We also may experience
numerous unforeseen events during, or as a result of, any future clinical studies or clinical trials that we could conduct that could delay or prevent our
ability to receive marketing approval or commercialize our product candidates, including:
•
we may be unable to generate sufficient preclinical, toxicology, or other in vivo or in vitro data to support the initiation of clinical trials for
therapeutic indications or the marketing of our products as non-drug products;
•
regulators or IRBs, ethics committees, or ECs may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial
at a prospective trial site;
•
we may experience delays in reaching, or fail to reach, agreement on acceptable terms with prospective trial sites and prospective contract
research organizations (“CROs”), or CROs, the terms of which can be subject to extensive negotiation and may vary significantly among
different CROs and trial sites;
•
clinical trials of any product candidates may fail to show safety, potency, or produce negative or inconclusive results and we may decide, or
regulators may require us, to conduct additional preclinical studies or clinical trials or we may decide to abandon product development
programs;
•
the number of patients required for clinical trials of any product candidates may be larger than we anticipate, enrollment in these clinical
trials may be more complicated or slower than we anticipate, or participants may drop out of these clinical trials or fail to return for post-
treatment follow-up at a higher rate than we anticipate;
•
we may need to add new or additional clinical trial sites;
•
our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or
at all, or may deviate from the clinical trial protocol or drop out of the trial, which may require that we add new clinical trial sites or
investigators;
•
the cost of preclinical studies, clinical studies and clinical trials of any product candidates may be more than we anticipate or more than our
available financial resources;
•
the supply or quality of our product candidates or other materials necessary to conduct clinical studies and clinical trials of our product
candidates may be insufficient or inadequate and may not achieve compliance with applicable cGMPs;
•
our product candidates may have undesirable side effects or other unexpected characteristics, causing us or our investigators, regulators or
IRBs or ECs to suspend or terminate clinical studies and clinical trials, or reports may arise from preclinical or clinical testing of our product
candidates that raise safety or efficacy concerns about our product candidates;
•
preclinical studies, clinical studies or clinical trials of our product candidates may produce negative or inconclusive results, which may result
in our deciding, or regulators requiring us, to conduct additional clinical trials or abandon product development programs; and
•
the FDA or other regulatory authorities may disagree with the design, implementation or results of our clinical studies or clinical trials or
require us to submit additional data such as long-term toxicology studies or impose other requirements before permitting us to initiate a
clinical trial.
We could also encounter delays if a preclinical study, clinical study or clinical trial is suspended or terminated for any reason. A suspension or termination
may be imposed due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical
protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold,
unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a product or treatment, failure to establish or achieve clinically
meaningful trial endpoints, changes in governmental regulations or
39
administrative actions or lack of adequate funding to continue the clinical trial. Many of the factors that cause, or lead to, a delay in the commencement or
completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates for therapeutic indications. Further, the
FDA or other regulatory authorities may disagree with our clinical trial design and our interpretation of data from clinical trials or may change the
requirements for approval even after they have reviewed and commented on the design for our preclinical studies, clinical studies or clinical trials. For
example, we may utilize an “open-label” trial design for some of our future clinical trials. An open-label trial is one where both the patient and investigator
know whether the patient is receiving the test article or either an existing approved drug or placebo. Open-label trials are subject to various limitations that
may exaggerate any therapeutic effect as patients in open-label studies are aware that they are receiving treatment. Open-label trials may be subject to a
“patient bias” where patients perceive their symptoms to have improved merely due to their awareness of receiving an experimental treatment. Open-label
trials may be subject to an “investigator bias” where those assessing and reviewing the physiological outcomes of the clinical trials are aware of which
patients have received treatment and may interpret the information of the treated group more favorably given this knowledge. The opportunity for bias in
clinical trials as a result of open-label design may not be adequately handled and may cause any of our trials that utilize such design to fail and additional
trials may be necessary to support future marketing applications.
Our product development costs will increase if we experience delays in clinical testing or marketing approvals. We do not know whether any of our
preclinical studies, clinical studies or clinical trials will begin as planned, will need to be restructured or will be completed on schedule, or at all. Significant
preclinical studies, clinical studies or clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize
our product candidates and may allow our competitors to bring products to market before we do, potentially impairing our ability to successfully
commercialize our product candidates and harming our business and results of operations. Any delays in our preclinical or future clinical development
programs may harm our business, financial condition and prospects significantly.
Our planned clinical trials or those of our future collaborators may reveal significant adverse events not seen in our preclinical studies, clinical studies
or other clinical trials and may result in a safety profile that could inhibit regulatory approval or market acceptance of any of our product candidates.
Before obtaining regulatory approvals for the commercial sale of any products for therapeutic indications, we must demonstrate through lengthy, complex
and expensive preclinical studies, clinical studies and clinical trials that our product candidates are both safe and effective for use in each target indication.
Preclinical and clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time
during the preclinical or clinical trial process. The results of preclinical studies, clinical studies as well as early clinical trials of our product candidates may
not be predictive of the results of later-stage clinical trials. In addition, initial success in clinical trials may not be indicative of results obtained when such
clinical trials are completed. There is typically an extremely high rate of attrition from the failure of product candidates proceeding through clinical trials.
We believe that our product candidates for therapeutic indications will be well tolerated by participants in our clinical trials, but we are not certain that we
will be able to dose trial participants at a high enough dose that will demonstrate efficacy without unacceptable safety risk. Our product candidates are
expected to have limited systemic exposure after oral administration but if the product candidates we use in our clinical trials are absorbed by the body,
participants may suffer adverse effects. There is also a concern that the microbiome could re-configure itself in such a way as to cause a limited time
window of effectiveness and tolerability of our product candidates or unanticipated short or long-term effects.
Product candidates in later stages of clinical trials also may fail to show the desired safety and efficacy profile despite having progressed through
preclinical studies and initial clinical trials. A number of companies in the healthcare industry have suffered significant setbacks in advanced clinical trials
due to lack of efficacy or unacceptable safety issues, notwithstanding promising results in earlier clinical trials. Most product candidates that commence
clinical trials are never approved as products for therapeutic indications and there can be no assurance that any of our current or future clinical trials will
ultimately be successful or support further clinical development or commercialization of any of our product candidates.
If significant adverse events or other side effects are observed in any of our current or future clinical trials, we may have difficulty recruiting patients to our
clinical trials, patients may drop out of our clinical trials or we may be
40
required to significantly redesign or abandon trials or our development efforts of one or more product candidates altogether. We, the FDA or other
applicable regulatory authorities or an IRB or EC may suspend clinical trials of a product candidate at any time for various reasons, including a belief that
patients in such trials are being exposed to unacceptable health risks or adverse side effects. Some potential therapeutics developed in the healthcare
industry that initially showed therapeutic promise in early-stage clinical trials have later been found to cause side effects that prevented their further
development. Even if the side effects do not preclude the drug from obtaining or maintaining marketing approval, undesirable side effects may inhibit
market acceptance of the approved product due to its tolerability versus other therapies. Any of these developments could materially harm our business,
financial condition and prospects.
Positive results from early preclinical studies, clinical studies and clinical trials of our product candidates are not necessarily predictive of the results of
later preclinical studies, clinical studies and any future clinical trials of our product candidates for therapeutic indications. If we cannot replicate the
positive results from our earlier preclinical studies of our product candidates in our later preclinical studies and future clinical studies and clinical
trials, we may be unable to successfully develop, obtain regulatory approval for and commercialize our product candidates.
Any positive results from our preclinical studies, clinical studies and clinical trials of our product candidates may not necessarily be predictive of the results
from required later preclinical studies, clinical studies and clinical trials. Similarly, even if we are able to complete our planned preclinical studies or any
future clinical studies and clinical trials of our product candidates according to our current development timeline, the positive results from such preclinical
studies, clinical studies and clinical trials of our product candidates may not be replicated in subsequent preclinical studies, clinical studies or clinical trial
results.
Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in late-stage clinical trials after achieving positive
results in early-stage development and we cannot be certain that we will not face similar setbacks. These setbacks have been caused by, among other things,
preclinical findings made while clinical trials were underway, or safety or efficacy observations made in preclinical studies, clinical studies and clinical
trials, including previously unreported adverse events. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses
and many companies that believed their product candidates performed satisfactorily in preclinical studies, clinical studies and clinical trials nonetheless
failed to obtain FDA or EMA approval.
If we encounter difficulties enrolling patients in our clinical studies or clinical trials, our clinical development activities could be delayed or otherwise
adversely affected.
We may experience difficulties in patient identification and enrollment in our clinical studies and clinical trials for a variety of reasons. The timely
completion of clinical studies or clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number
of patients who remain in the clinical study or clinical trial until its conclusion. The enrollment of patients depends on many factors, including, but not
limited to:
•
the severity of the disease or condition under investigation for product candidates developed as therapeutics;
•
the patient eligibility and exclusion criteria defined in the protocol;
•
the size of the study patient population required for analysis of the primary endpoint(s) of the clinical study or clinical trial;
•
the proximity of patients to study sites;
•
the design of the clinical study or trial;
•
our ability to recruit investigators with the appropriate competencies and experience;
•
clinicians’ and patients’ perceptions as to the potential advantages and risks of the product candidate being studied in relation to other
available therapies, including any new drugs that may be approved for the indications we are investigating;
41
•
the efforts to facilitate timely enrollment in clinical studies or trials;
•
the patient referral practices of physicians;
•
the ability to monitor patients adequately during and after treatment;
•
our ability to obtain and maintain patient consents; and the risk that patients enrolled in clinical studies or clinical trials will drop out of the
clinical studies or clinical trials before completion.
In addition, our clinical studies or trials will compete with other clinical studies or trials for product candidates that are in the same therapeutic areas as our
product candidates, and this competition will reduce the number and types of patients available to us, because some patients who might have opted to enroll
in our clinical studies or trials may instead opt to enroll in a study or trial being conducted by one of our competitors. Since the number of qualified clinical
investigators is limited, we expect to conduct some of our clinical studies or trials at the same clinical trial sites that some of our competitors use, which
will reduce the number of patients who are available for our clinical trials in such clinical trial site. Moreover, because our product candidates represent a
departure from more commonly used methods for our targeted therapeutic areas, potential patients and their doctors may be inclined to use conventional
therapies, rather than enroll patients in any future clinical study or trial.
Delays in patient enrollment may result in increased costs or may affect the timing or outcome of the planned clinical studies or trials, which could prevent
completion of these clinical studies or trials and adversely affect our ability to advance the development of our product candidates.
Interim top-line and preliminary data from our clinical studies or clinical trials that we announce or publish from time to time may change as more
patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
From time to time, we expect to publish interim top-line or preliminary data from our clinical studies and clinical trials. Interim data from these clinical
studies and clinical trials that we may complete are subject to the risk that one or more of the outcomes may materially change as patient enrollment
continues, and more patient data become available. Preliminary or top-line data also remain subject to audit and verification procedures that may result in
the final data being materially different from the preliminary data we previously published. As a result, interim and preliminary data should be viewed with
caution until the final data are available. Adverse differences between preliminary or interim data and final data could significantly harm our business
prospects.
If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could
have a material adverse effect on the success of our business.
We are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use,
storage, treatment and disposal of hazardous materials and wastes. Our research and development activities involve the use of biological and hazardous
materials and produce hazardous waste products. We generally contract with third parties for the disposal of these materials and wastes. We cannot
eliminate the risk of contamination or injury from these materials, which could cause an interruption of our commercialization efforts, research and
development efforts and business operations, environmental damage resulting in costly clean-up and liabilities under applicable laws and regulations
governing the use, storage, handling and disposal of these materials and specified waste products. Although we believe that the safety procedures utilized
by our third-party manufacturers for handling and disposing of these materials generally comply with the standards prescribed by these laws and
regulations, we cannot guarantee that this is the case or eliminate the risk of accidental contamination or injury from these materials. In such an event, we
may be held liable for any resulting damages and such liability could exceed our resources and state or federal or other applicable authorities may curtail
our use of certain materials and/or interrupt our business operations. Furthermore, environmental laws and regulations are complex, change frequently and
have tended to become more stringent. We cannot predict the impact of such changes and cannot be certain of our future compliance. In addition, we may
incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and
regulations may impair our research, development or production efforts. Failure to comply with these laws and regulations also may result in substantial
fines, penalties or other sanctions.
42
Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from
the use of biological waste or hazardous materials or other work-related injuries, this insurance may not provide adequate coverage against potential
liabilities. We do not carry specific biological waste or hazardous waste insurance coverage or workers compensation or property and casualty and general
liability insurance policies that include coverage for damages and fines arising from biological or hazardous waste exposure or contamination.
If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product
candidates.
We face an inherent risk of product liability as a result of testing our product candidates in clinical studies and clinical trials and will face an even greater
risk if we commercialize any products. For example, we may be sued if our product candidates cause or are perceived to cause injury or are found to be
otherwise unsuitable during clinical studies, clinical trials, manufacturing, marketing or sale. Any such product liability claims may include, but are not
limited to, allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a
breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves against product
liability claims, we may incur substantial liabilities or be required to limit commercialization of our product candidates. Even successful defense would
require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:
•
inability to bring a product candidate to the market;
•
decreased demand for our products;
•
damage to our reputation;
•
withdrawal of clinical study or clinical trial participants and patients and inability to enroll future participants or continue clinical studies or
clinical trials;
•
initiation of investigations by regulators;
•
costs to defend the related litigation or implement corrective actions;
•
diversion of management’s time and our resources;
•
substantial monetary awards to participants or patients;
•
product recalls, withdrawals or labeling, marketing or promotional restrictions;
•
loss of revenue;
•
exhaustion of any available insurance and our capital resources;
•
the inability to commercialize any product candidate via any regulatory pathway; and
•
decline in our share price.
We maintain clinical trial insurance. We review our clinical trial insurance policy annually and we believe that our coverage is currently adequate to cover
any claims that may arise in connection with our clinical studies or clinical trials. There is no guarantee that we will be able to obtain additional clinical
trial insurance at an acceptable cost in the future, which could prevent or inhibit the ongoing development of our products.
Since we have not yet commenced marketing of any products, we do not yet hold product liability insurance for commercialization of our products. Our
inability to obtain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the
commercialization of products we develop, alone or with collaborators. If and when coverage is secured, our insurance policies may also have various
exclusions, and we may be subject to a product liability claim for which we have no coverage. We may have to pay any amounts awarded by a court or
negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain,
sufficient capital to pay such amounts. Even if our agreements with any future corporate collaborators entitle us to indemnification against losses, such
indemnification may not be available or adequate should any claim arise.
43
The market opportunities for our product candidates may be limited and our estimates of the incidence and prevalence of our target patient populations
may be inaccurate.
Our projections of the market sizes we may target and number of people who have the diseases or conditions we target, as well as the subset of people with
these diseases in a position to receive our therapies, if approved, are based on our beliefs and estimates. These estimates have been derived from a variety
of sources, including scientific literature, input from key opinion leaders, patient foundations or secondary market research databases, and may prove to be
incorrect. Further, new studies may change the estimated incidence or prevalence of these diseases or regulatory approvals may include limitations for use
or contraindications that decrease the addressable patient population for product candidates we decide to develop as drug product candidates. The number
of individuals may turn out to be lower than expected. Additionally, the potentially addressable patient population for our product candidates that we decide
to develop as drugs may be limited or may not be amenable to treatment with our product candidates. Even if we obtain significant market share for our
product candidates, because certain of the potential target populations are small, we may never achieve profitability without obtaining regulatory approval
for additional indications or expanding the target market size for non-drug products.
We are early in our development efforts and may not be successful in our efforts to use our proprietary product platform to build a pipeline of product
candidates and develop marketable products.
We are developing our proprietary product platform to systematically direct functional outputs of the microbiome organ. However, our proprietary product
platform has not yet, and may never lead to, FDA approved or commercialized products. We are developing our initial product candidates and additional
product candidates that we intend to use in a number of areas of health and disease, including UC and COPD. We may have problems applying our
technologies to these other areas, and our product candidates may not demonstrate a comparable ability in treating disease as our initial product candidates.
Even if we are successful in identifying additional product candidates, they may not be suitable for clinical development as a result of our inability to
manufacture the compounds, limited efficacy, unacceptable safety profiles or other characteristics that indicate that they are unlikely to be products that will
receive marketing approval and achieve market acceptance.
If we do not successfully develop and commercialize product candidates based upon our platform approach, we will not be able to obtain product revenue
in future periods, which likely would result in significant harm to our financial position and adversely affect our stock price.
We face significant competition from other healthcare companies, and our operating results will suffer if we fail to compete effectively.
The healthcare industry is characterized by intense competition and rapid innovation. Our competitors may be able to develop other compounds or products
that are able to achieve similar or better results. Our potential competitors include major multinational pharmaceutical companies, nutritional foods
companies, established biotechnology companies, specialty pharmaceutical companies and universities and other research institutions. Many of our
competitors have substantially greater financial, technical and other resources, such as larger research and development staff, experienced marketing and
manufacturing organizations and well-established sales forces. Smaller or early-stage companies may also prove to be significant competitors, particularly
through collaborative arrangements with large, established companies. Established pharmaceutical companies may also invest heavily to accelerate
discovery and development of novel therapeutics or to in-license novel therapeutics that could make the product candidates that we develop obsolete.
Mergers and acquisitions in the healthcare industry may result in even more resources being concentrated amongst our competitors. Competition may
increase further as a result of advances in the commercial applicability of technologies and greater availability of capital for investment in these industries.
Our competitors, either alone or with collaborative partners, may succeed in developing, acquiring or licensing on an exclusive basis microbiome therapies
that are more effective, safer, more easily commercialized or less costly than our product candidates or may develop proprietary technologies or secure
patent protection that we may need for the development of our technologies and products. We believe the key competitive factors that will affect the
development and commercial success of our product candidates are efficacy, safety, tolerability, reliability, convenience of use, price and reimbursement.
We anticipate competing with the largest healthcare companies in the world, all of which have greater financial and human resources than we currently
have. In addition to these fully integrated healthcare companies, we also compete
44
with those companies whose products target the same indications as our product candidates. They include pharmaceutical companies, biotechnology
companies, academic institutions and other research organizations. Any treatments developed by our competitors could be superior to our product
candidates. It is possible that these competitors will succeed in developing technologies that are more effective than our products or that would render our
product candidates obsolete or noncompetitive. We anticipate that we will face increased competition in the future as additional companies enter our market
and scientific developments surrounding other therapies targeted at the microbiome continue to accelerate. In addition, there are a number of other
companies targeting the microbiome.
Even if we obtain regulatory approval to market our product candidates or are successful in identifying alternate regulatory pathways to market for our
product candidates, the availability and price of our competitors’ products could limit the demand and the price we are able to charge for our product
candidates. We may not be able to implement our business plan if the acceptance of our product candidates is inhibited by price competition or the
reluctance of physicians to switch from existing methods of treatment to our product candidates, or if physicians switch to other new drug or biologic
products or choose to reserve our product candidates for use in limited circumstances.
Even if a product candidate we develop as a therapeutic receives marketing approval, it may fail to achieve the degree of market acceptance by
physicians, patients, third-party payors, consumers and others in the medical or healthcare community necessary for commercial success.
If any product candidate we develop receives marketing approval as a therapeutic, it may nonetheless fail to gain sufficient market acceptance by
physicians, patients, third-party payors, consumers and others in the medical community. If the product candidates we develop do not achieve an adequate
level of acceptance, we may not generate significant product revenues and we may not become profitable. The degree of market acceptance of any product
candidate, if approved for commercial sale, will depend on a number of factors, including:
•
efficacy, safety and potential advantages compared to alternative treatments;
•
the labeled uses or limitations for use, including age limitations or contraindications, for our product candidates compared to alternative
treatments;
•
convenience and ease of administration compared to alternative treatments;
•
the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
•
public perception of new therapies and non-therapeutic products, including our MMTs;
•
the strength of marketing and distribution support;
•
the ability to offer our products, if approved, for sale at competitive prices;
•
the ability to obtain sufficient third-party insurance coverage and adequate reimbursement; and
•
the prevalence and severity of any side effects.
If we are to continue as a going concern, we will need to grow the size of our organization, and we may experience difficulties in managing this growth.
If we continue as a going concern and if our research, development, manufacturing and commercialization plans and strategies develop, we expect to need
additional managerial, operational, sales, marketing, financial and other personnel. Future growth would impose significant added responsibilities on
members of management, including:
•
identifying, recruiting, compensating, integrating, maintaining and motivating additional employees;
•
managing our internal research and development efforts effectively, including identification of clinical candidates, scaling our manufacturing
process and navigating the clinical and FDA review process for our product candidates; and
•
improving our operational, financial and management controls, reporting systems and procedures.
45
Our future financial performance and our ability to commercialize our product candidates will depend, in part, on our ability to effectively manage any
future growth, and our management may also have to divert a disproportionate amount of its attention away from day-to-day activities in order to devote a
substantial amount of time to managing these growth activities.
We currently rely, and for the foreseeable future will continue to rely, in substantial part on certain organizations, advisors and consultants to provide
certain services, including many aspects of regulatory affairs, clinical management and manufacturing. There can be no assurance that the services of these
organizations, advisors and consultants will continue to be available to us on a timely basis when needed or that we can find qualified replacements. In
addition, if we are unable to effectively manage our outsourced activities or if the quality or accuracy of the services provided by consultants is
compromised for any reason, our clinical trials may be extended, delayed or terminated, and we may not be able to obtain regulatory approval of our
product candidates or otherwise advance our business. There can be no assurance that we will be able to manage our existing consultants or find other
competent outside contractors and consultants on economically reasonable terms, or at all.
If we are not able to effectively expand our organization by hiring new employees and expanding our groups of consultants and contractors, we may not be
able to successfully implement the tasks necessary to further develop and commercialize our product candidates and, accordingly, may not achieve our
research, development and commercialization goals.
If we lose key management personnel, or if we fail to recruit additional highly skilled personnel, our ability to identify and develop new or next
generation product candidates will be impaired, could result in loss of markets or market share and could make us less competitive.
Our ability to compete in the highly competitive healthcare industry depends upon our ability to attract and retain highly qualified managerial, scientific
and medical personnel. From time to time, there may be changes in our executive management team resulting from the hiring or departure of executives.
The loss of the services of any of our executive officers, other key employees, and other scientific and medical advisors, and our inability to find suitable
replacements could result in delays in product development and harm our business to continue as a going concern.
We conduct our operations in Massachusetts. Competition for skilled personnel in our market is intense and may limit our ability to hire and retain highly
qualified personnel on acceptable terms or at all. To induce valuable employees to remain at our company, in addition to salary and cash incentives, we
have provided restricted stock and stock options that vest over time. The value to employees of stock options that vest over time may be significantly
affected by movements in our stock price that are beyond our control and may at any time be insufficient to counteract more lucrative offers from other
companies. Despite our efforts to retain valuable employees, members of our management, scientific and development teams may terminate their
employment with us on short notice. Employment of our key employees is at-will, which means that any of our employees could leave our employment at
any time, with or without notice. We do not maintain “key man” insurance policies on the lives of these individuals or the lives of any of our other
employees. Our success also depends on our ability to continue to attract, retain and motivate highly skilled junior, mid-level and senior managers as well
as junior, mid-level and senior scientific and medical personnel.
COVID-19 may materially and adversely affect our business and our financial results.
The recent COVID-19 pandemic was first reported in Wuhan, China in December 2019 and has since spread globally, including to the United States and
European countries. The continued spread of COVID-19, including the identification of novel strains of COVID-19, could adversely impact our operations,
including our ability to initiate or complete clinical trials, manufacture sufficient supply of our product candidates or to manufacture our product candidates
at sufficient scale for commercialization. Any delay in operations could adversely affect our ability to commercialize our product candidates, particularly
on our current projected timelines, increase our operating expenses and have a material adverse effect on our business and financial results. For example,
because of limitations on patient visits and the impact on new enrollment due to the COVID-19 pandemic, a Phase 2 clinical trial of one of our prior
product candidates was delayed.
46
If any of our third-party manufacturers is adversely impacted by the COVID-19 pandemic or if they divert resources or manufacturing capacity to
accommodate the development or manufacture of a COVID-19 coronavirus vaccine, our supply chain may be disrupted, limiting our ability to supply our
product candidates for our research and development. As a result of the COVID-19 pandemic, we have experienced, and may continue to experience,
disruptions that impact our business, preclinical studies and clinical trials.
The COVID-19 pandemic has also resulted in significant governmental measures being implemented to control the spread of the virus, including
quarantines, travel restrictions, social distancing and business shutdowns. We have taken temporary precautionary measures intended to help minimize the
risk of the virus to our employees, including temporarily requiring most employees to work remotely. We have already suspended non-essential travel
worldwide for our employees and are discouraging employee attendance at other gatherings. These measures could negatively affect our business. For
instance, temporarily requiring all employees to work remotely may induce absenteeism, disrupt our operations or increase the risk of a cybersecurity
incident. The COVID-19 pandemic has also caused volatility in the global financial markets and threatened a slowdown in the global economy, which may
negatively affect our ability to raise additional capital on attractive terms or at all.
The extent to which the COVID-19 pandemic may impact our business will depend on future developments, which are highly uncertain and cannot be
predicted with confidence, such as the duration of the pandemic, the severity of COVID-19 or the effectiveness of actions to contain and treat COVID-19,
particularly in the geographies where we or our third party suppliers and contract manufacturers, including those for our approved hospital products
portfolio, or contract research organizations operate. We cannot presently predict the scope and severity of any potential business or regulatory shutdowns
or disruptions. If we or any of the third parties with whom we engage, however, were to experience shutdowns or other business disruptions, our ability to
conduct our business in the manner and on the timelines presently planned could be materially and negatively affected, which could have a material adverse
impact on our business and our results of operations and financial condition.
Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
Our operations, and those of our CROs, contract manufacturing organizations, or CMOs, and other contractors and consultants, could be subject to
earthquakes, power shortages, telecommunications failures, water shortages, floods, hurricanes, typhoons, fires, extreme weather conditions, medical
epidemics and other natural or man-made disasters or business interruptions, for which we are predominantly self-insured. The occurrence of any of these
business disruptions could seriously harm our operations and financial condition and increase our costs and expenses. For our clinical studies, we rely on
third-party manufacturers for spray drying the MMTs substance and filling sachets with the resulting spray-dried powder. For materials to be used in our
clinical trials, we plan to rely on an external contract manufacturing organization for the entire manufacturing supply chain. Our ability to obtain clinical
supplies of our product candidates could be disrupted if the operations of these suppliers are affected by a man-made or natural disaster or other business
interruption.
Our current operations are located in Massachusetts, and we or the third parties upon whom we depend may be adversely affected by natural disasters
and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
Our current operations are located in Massachusetts. Any unplanned event, such as flood, fire, explosion, earthquake, extreme weather condition, medical
epidemics, power shortage, telecommunication failure or other natural or manmade accidents or incidents that result in us being unable to fully utilize our
facilities, or the manufacturing facilities of our third-party contract manufacturers, may have a material and adverse effect on our ability to operate our
business, particularly on a daily basis, and have significant negative consequences on our financial and operating conditions. Loss of access to these
facilities may result in increased costs, delays in the development of our product candidates or interruption of our business operations. Earthquakes or other
natural disasters could further disrupt our operations and have a material and adverse effect on our business, financial
47
condition, results of operations and prospects. If a natural disaster, power outage or other event occurred that prevented us from using all or a significant
portion of our headquarters, that damaged critical infrastructure, such as our research facilities or the manufacturing facilities of our third-party contract
manufacturers, or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible, for us to continue our business for a substantial
period of time. The disaster recovery and business continuity plans we have in place may prove inadequate in the event of a serious disaster or similar
event. We may incur substantial expenses as a result of the limited nature of our disaster recovery and business continuity plans, which could have a
material adverse effect on our business. As part of our risk management policy, we maintain insurance coverage at levels that we believe are appropriate for
our business. However, in the event of an accident or incident at these facilities, we cannot assure you that the amounts of insurance will be sufficient to
satisfy any damages and losses. If our facilities, or the manufacturing facilities of our third-party contract manufacturers, are unable to operate because of
an accident or incident or for any other reason, even for a short period of time, any or all of our research and development programs may be harmed. Any
business interruption may have a material and adverse effect on our business, financial condition, results of operations and prospects.
Our internal computer systems, or those used by our CROs, CMOs or other contractors or consultants, may fail or suffer security breaches.
Despite the implementation of security measures, our internal computer systems and those of our future CROs, CMOs and other contractors and
consultants are vulnerable to damage from computer viruses and unauthorized access. While we have not experienced any such material system failure or
security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our development
programs and our business operations. For example, the loss of clinical trial data from completed or future clinical trials could result in delays in our
regulatory approval efforts and significantly increase our costs to recover or reproduce the data. Likewise, we currently rely on third parties for the
manufacture of our product candidates and to conduct clinical trials, and similar events relating to their computer systems could also have a material
adverse effect on our business. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or
inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development and commercialization of our
product candidates could be delayed.
Regulators globally are also imposing greater monetary fines for privacy violations. For example, in 2016, the European Union adopted a new regulation
governing data practices and privacy called the GDPR, which became effective on May 25, 2018. The GDPR applies to any company that collects and uses
personal data in connection with offering goods or services to individuals in the European Union or the monitoring of their behavior. Non-compliance with
the GDPR may result in monetary penalties of up to €20 million or 4% of worldwide revenue, whichever is higher. The GDPR and other changes in laws or
regulations associated with the enhanced protection of certain types of personal data, such as healthcare data or other sensitive information, could greatly
increase the cost of providing our product candidates, if approved, or even prevent us from offering our product candidates, if approved, in certain
jurisdictions.
Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities,
including noncompliance with regulatory standards and requirements.
We are exposed to the risk of employee fraud or other illegal activity by our employees, independent contractors, consultants, commercial partners and
vendors. Misconduct by these parties could include intentional, reckless and/or negligent conduct that fails to comply with the laws of the FDA and other
similar foreign regulatory bodies, provide true, complete and accurate information to the FDA and other similar foreign regulatory bodies, comply with
manufacturing standards we have established, comply with healthcare fraud and abuse laws in the United States and similar foreign fraudulent misconduct
laws or report financial information or data accurately or to disclose unauthorized activities to us. If we obtain FDA approval of any of our product
candidates and begin commercializing those products in the United States, our potential exposure under such laws will increase significantly, and our costs
associated with compliance with such laws are also likely to increase. These laws may impact, among other things, our current activities with principal
investigators and research patients, as well as proposed and future sales, marketing and education programs.
For our drug product candidates, our relationships with healthcare providers, physicians and third-party payors will be subject to applicable anti-
kickback, fraud and abuse and other healthcare laws and regulations, which
48
could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
If we obtain FDA approval for any of our product candidates and begin commercializing those products in the U.S., our operations may be directly, or
indirectly through our future, potential customers and third-party payors, subject to various federal and state fraud and abuse laws, including, without
limitation, the federal Anti-Kickback Statute, the federal False Claims Act (“FCA”), and data privacy and physician sunshine laws and regulations. These
laws or their relevant foreign counterparts may impact, among other things, our proposed sales, marketing, and education programs and our relationships
with healthcare providers, physicians and other parties through which we market, sell and distribute our products for which we obtain marketing approval.
In addition, we may be subject to patient privacy regulation by the federal government and the states in the U.S. as well as other jurisdictions. See section
entitled “Business – Government Regulation – Other Healthcare and Privacy Laws.”
The distribution of pharmaceutical products is subject to additional requirements and regulations, including extensive record-keeping, licensing, storage
and security requirements intended to prevent the unauthorized sale of pharmaceutical products.
The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform. Federal and state
enforcement bodies have recently increased their scrutiny of interactions between healthcare companies and healthcare providers, which has led to a
number of investigations, prosecutions, convictions and settlements in the healthcare industry. Ensuring business arrangements comply with applicable
healthcare laws, as well as responding to possible investigations by government authorities, can be time- and resource-consuming, costly, and can divert a
company's attention from the business.
It is possible that governmental and enforcement authorities will conclude that our business practices may not comply with current or future statutes,
regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations. If any such actions are instituted against us and we
are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of
civil, criminal and administrative penalties, damages, disgorgement, monetary fines, imprisonment, possible exclusion from participation in Medicare,
Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, curtailment of our
operations, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve
allegations of noncompliance with these laws, any of which could adversely affect our ability to operate our business and our results of operations.
In addition, the approval and commercialization of any of our product candidates outside the United States will also likely subject us to foreign equivalents
of the healthcare laws mentioned above, among other foreign laws.
A variety of risks associated with testing and developing our product candidates internationally could materially adversely affect our business.
We plan to seek regulatory approval of our product candidates for therapeutic and other uses outside of the United States and, accordingly, we expect that
we will be subject to additional risks related to operating in foreign countries if we obtain the necessary approvals, including:
•
differing regulatory requirements in foreign countries;
•
unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements;
•
economic weakness, including inflation, or political instability in particular foreign economies and markets;
•
compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;
•
foreign taxes, including withholding of payroll taxes;
•
foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to
doing business in another country;
•
difficulties staffing and managing foreign operations;
•
workforce uncertainty in countries where labor unrest is more common than in the United States;
49
•
potential liability under the Foreign Corrupt Practices Act, or FCPA, or comparable foreign regulations;
•
challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect
intellectual property rights to the same extent as the United States;
•
production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and
•
business interruptions resulting from geo-political actions, including war and terrorism.
Additionally, if we continue as a going concern, we intend to contract with third parties to conduct some of our clinical trials outside the United States,
which will subject us to additional risks and regulations. These and other risks associated with our international operations may materially adversely affect
our ability to attain or maintain profitable operations.
We currently have no marketing and sales organization and have no experience in marketing products for therapeutic or other non-drug uses. If we
are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, we may
not be able to generate product revenue.
We currently have no sales, marketing or distribution capabilities and have no experience in marketing products for therapeutic or other uses. If we
continue as a going concern, we intend to develop an in-house marketing organization and sales force, which will require significant capital expenditures,
management resources and time. We will have to compete with other healthcare companies to recruit, hire, train and retain marketing and sales personnel.
In addition to establishing internal sales, marketing and distribution capabilities, we intend to optimistically pursue collaborative arrangements regarding
the sales and marketing of our products, however, there can be no assurance that we will be able to establish or maintain such collaborative arrangements,
or if we are able to do so, that they will have effective sales forces. Any revenue we receive will depend upon the efforts of such third parties, which may
not be successful.
50
The FDA, the EMA and other regulatory authorities may implement additional regulations or restrictions on the development and commercialization
of products which act on the microbiome, which may be difficult to predict.
The FDA, the EMA and regulatory authorities in other countries have each expressed interest in further regulating biotechnology products and product
candidates, such as MMTs. Agencies at both the federal and state level in the United States, as well as the U.S. Congressional committees and other
governments or governing agencies, have also expressed interest in further regulating the biotechnology industry. Such action may delay or prevent
commercialization of some or all of our product candidates. Adverse developments in clinical studies or clinical trials of MMT products conducted by
others may cause the FDA or other oversight bodies to change the requirements for approval of any of our product candidates. Similarly, the EMA governs
the development of MMTs as drugs in the European Union and member state regulatory bodies govern the development of MMTs under food regulations
and may issue new guidelines concerning the development and marketing authorization for MMT products and require that we comply with these new
guidelines. These regulatory review agencies and committees and the new requirements or guidelines they promulgate may lengthen the regulatory review
process, require us to perform additional studies or trials, increase our development costs, lead to changes in regulatory positions and interpretations, delay
or prevent approval and commercialization of our product candidates or lead to significant post-approval limitations or restrictions. As we advance our
product candidates, we will be required to consult with these regulatory agencies and comply with applicable requirements and guidelines. If we fail to do
so, we may be required to delay or discontinue development of such product candidates. These additional processes may result in a review and approval
process that is longer than we otherwise would have expected, delays as a result of an increased or lengthier regulatory approval process or further
restrictions on the development of our product candidates can be costly and could negatively impact our ability to complete clinical trials and
commercialize our current and future product candidates in a timely manner, if at all.
Changes in tax laws could affect our business and financial condition.
The rules dealing with U.S. federal, state, and local income taxation are constantly under review by persons involved in the legislative process and by the
Internal Revenue Service and the U.S. Treasury Department. Changes to tax laws (which changes may have retroactive application) could adversely affect
us or holders of our common stock. In recent years, many such changes have been made and changes are likely to continue to occur in the future. Future
changes in tax laws could have a material adverse effect on our business, cash flow, financial condition or results of operations. We urge investors to
consult with their legal and tax advisers regarding the implications of potential changes in tax laws on an investment in our common stock.
Our ability to use net operating losses and research and development credits to offset future taxable income may be subject to certain limitations.
As of December 31, 2021, we had net operating loss, or NOL, carryforwards for U.S. federal and state tax purposes of $318.6 million and $348.4 million,
respectively. Federal NOLs of $38.8 million, generated before 2018, will begin expiring in varying amounts in 2035 unless utilized and the remaining NOL
of $279.8 million, generated after 2018 will be carried forward indefinitely and could be used up to 80% of taxable income of each future tax year. The
Commonwealth of Massachusetts does not follow federal on NOL carryforwards and as such the Company’s Massachusetts NOLs of $271.6 million will
expire in at various times starting in 2035. As of December 31, 2021, we also had U.S. federal and state research and development tax credit carryforwards
of $6.5 million and $3.6 million respectively, both of which expire at various dates through 2040. These net operating loss and tax credit carryforwards
could expire unused and be unavailable to offset future taxable income or tax liabilities, respectively. In addition, in general, under Sections 382 and 383 of
the Internal Revenue Code of 1986, as amended, or the Code, and corresponding provisions of state law, a corporation that undergoes an “ownership
change” is subject to limitations on its ability to utilize its pre-change net operating loss carryforwards or tax credits, or credits, to offset future taxable
income or taxes. For these purposes, an ownership change generally occurs where the aggregate stock ownership of one or more stockholders or groups of
stockholders who owns at least 5% of a corporation’s stock increases its ownership by more than 50 percentage points over its lowest ownership percentage
within a specified testing period. Our existing NOLs or credits may be subject to limitations arising from previous ownership changes, and if we undergo
an ownership change, our ability to utilize NOLs or credits could be further limited by Sections 382 and 383 of the Code. In addition, future changes in our
stock ownership, many of which are outside of our control, could result in an ownership change under Sections 382 and 383 of the Code. Our NOLs or
credits may also
51
be impaired under state law. Accordingly, we may not be able to utilize a material portion of our NOLs or credits. Furthermore, our ability to utilize our
NOLs or credits is conditioned upon our attaining profitability and generating U.S. federal and state taxable income. As described above under “Risk
Factors—Risks Related to Our Business, Technology and Industry,” we have incurred significant net losses since our inception and anticipate that we will
continue to incur significant losses for the foreseeable future; and therefore, we do not know whether or when we will generate the U.S. federal or state
taxable income necessary to utilize our NOLs or credits that are subject to limitation by Sections 382 and 383 of the Code.
Unstable market, political, and economic conditions may have serious adverse consequences on our business, financial condition and stock price.
As widely reported, global credit and financial markets have experienced extreme volatility and disruptions in the past, including severely diminished
liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates and uncertainty about
economic stability. In addition, the current military conflict between Russia and Ukraine could disrupt or otherwise adversely impact our operations and
those of third parties upon which we rely. Related sanctions, export controls or other actions that may be initiated by nations including the U.S., the
European Union or Russia (e.g., potential cyberattacks, disruption of energy flows, etc.), which could adversely affect our business and/or our supply chain,
our CROs, CMOs and other third parties with which we conduct business. There can be no assurance that further deterioration in credit and financial
markets and confidence in economic conditions will not occur. Our general business strategy may be adversely affected by any such economic downturn,
volatile business environment or continued unpredictable and unstable market conditions. If the current equity and credit markets deteriorate, or do not
improve, it may make any necessary debt or equity financing more difficult, more costly, and more dilutive. Failure to secure any necessary financing in a
timely manner and on favorable terms could have a material adverse effect on our growth strategy, financial performance and stock price and could require
us to delay or abandon clinical development plans. In addition, there is a risk that one or more of our current service providers, manufacturers and other
partners may not survive these difficult economic times, which could directly affect our ability to attain our operating goals on schedule and on budget.
As of December 31, 2021, we had cash and cash equivalents of approximately $38.5 million. While we are not aware of any downgrades, material losses or
other significant deterioration in the fair value of our cash equivalents since December 31, 2021, no assurance can be given that further deterioration of the
global credit and financial markets would not negatively impact our current portfolio of cash equivalents or our ability to meet our financing objectives.
Furthermore, our stock price may decline due in part to the volatility of the stock market and the general economic downturn.
Risks related to government regulation
We are very early in our development efforts. All of our product candidates will require significant additional preclinical and clinical development
before we seek regulatory approval of our therapeutic product candidates or identify alternate regulatory pathways to market for our non-therapeutic
products and launch a product commercially. If we are unable to advance our product candidates to clinical development, obtain regulatory approval
and ultimately commercialize our product candidates or experience significant delays in doing so, our business will be materially harmed.
We are very early in our development efforts and we have invested substantially all of our efforts and financial resources in the identification and early
clinical development of MMT candidates, including the development of our initial product candidates. Our ability to generate product revenues, which we
do not expect will occur for many years, if ever, will depend on the successful development and eventual commercialization of our product candidates,
which may never occur. We currently generate no revenue from sales of any products, and we may never be able to develop or commercialize a marketable
product. The success of our product candidates will depend on several factors, including, but not limited to, the following:
•
successful completion of preclinical studies, clinical studies and, where applicable, clinical trials;
•
clearance of INDs for our planned clinical trials or future clinical trials for therapeutic indications;
•
successful enrollment in, and completion of, clinical studies and clinical trials;
52
•
receipt of regulatory approvals from applicable regulatory authorities for therapeutic product candidates;
•
establishing cGMP-compliant clinical supply and commercial manufacturing operations or making arrangements with third-party
manufacturers for clinical supply and commercial manufacturing;
•
supplying sufficient quantities of our products at appropriate quality levels;
•
obtaining and maintaining patent and trade secret protection or regulatory exclusivity for our product candidates;
•
launching commercial sales of our product candidates, if and when approved or allowed for marketing, whether alone or in collaboration with
others;
•
acceptance of our therapeutic product candidates, if and when approved, by patients, the medical community and third-party payors or any
non-therapeutic product by consumers;
•
effectively competing with other therapies;
•
obtaining and maintaining third-party insurance coverage and adequate reimbursement;
•
enforcing and defending intellectual property rights and claims;
•
the marketing of our products; and
•
maintaining a continued acceptable safety profile of the product candidates following approval or commercialization.
If we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully
commercialize our product candidates, which would materially harm our business. If we do not receive regulatory approvals or identify alternate regulatory
pathways to market for our product candidates, we may not be able to continue our operations.
Regulatory requirements for development of our MMT candidates as drugs and non-drugs are uncertain and evolving. Changes in these laws,
including our ability to conduct clinical studies, or the current interpretation or application of these laws would have a significant adverse impact on
our ability to develop and commercialize our products.
In the United States, under sections 201(s) and 409 of the FD&C Act, any substance that is reasonably expected to become a component of food is
considered to be a food additive, and therefore subject to FDA premarket review and approval, unless the substance is generally recognized, among
qualified experts, as having been adequately shown to be safe under the conditions of its intended use. We believe that our initial product candidates are
safe for clinical studies, based on initial safety assessments conducted by third-party qualified experts and because they are related to a class of compounds
that is GRAS based on their history of safe human exposure, when utilized for particular uses as food substances. As a result, we believe we may use our
product candidates to conduct clinical studies in order to evaluate safety, tolerability and biomarkers for non-drug applications in advance of deciding
whether or not to file an IND. The FDA may determine that our MMT candidates are not governed by food regulations and therefore may classify any
product candidates as being ineligible for use in studies without an IND. The FDA or other regulatory authorities may also take enforcement action, or
otherwise delay or prevent further development or commercialization of our product candidates.
The FDA may determine that our product candidates cannot be marketed as or do not meet the regulatory requirements for marketing or testing as
conventional foods or medical foods. The FDA may not agree the products meet the medical food definition or the agency may take the position that we
failed to satisfy the premarket authorization requirements for GRAS ingredients or new dietary ingredients. Moreover, if we choose to study a product
under an IND before the product candidate has been marketed as a food, the first to market provisions of Section 301(ll) could prevent us from marketing
the product as a food if we are unable to secure FDA approval as a new drug. Any delay in the regulatory consultation process, or a determination that any
of our drug or food product candidates do not meet the regulatory requirements of the FDA, including any applicable GRAS requirements, could subject
the company to regulatory enforcement action, cause a delay in the commercialization of our product candidates, which may lead to reduced acceptance by
the public or others, and/or may result in some or all of our products may be deemed adulterated or misbranded in violation of the FD&C Act, any or all of
which may lead to reduced acceptance by the public or others for any products we are able to commercialize and could materially adversely affect our
business.
53
The FDA may determine that the only pathway for conducting clinical studies is under an IND. Any such determination could prevent our reliance on
existing regulatory frameworks to conduct clinical studies for other product candidates and could significantly increase the cost of and delay the
commercialization of our product candidates for therapeutic applications. If the FDA were to disagree with our determination that we may conduct clinical
studies in advance of filing an IND, they could ask us to halt any clinical trials we have commenced. For example, on August 27, 2021 we received a
warning letter from the FDA for failure to submit an IND prior to conducting two clinical studies., K031 and K032, of KB109 in subjects with COVID-19.
The warning letter followed receipt of a Form FDA 483 that was provided to us in March 2021 at the conclusion of a clinical inspection. The Form FDA
483 and warning letter were each based on a single observation that we failed to submit an IND for the conduct of these studies.
Should we choose to commercialize our food products, whether as conventional foods or medical foods, and if the FDA determines our product candidates
fall outside the food regulations, we may be subject to regulatory enforcement action and the agency could ask us to stop selling, withdraw, recall, re-label
or repackage any products we have commercialized as foods or non-drug products from the market. In addition, if new safety issues are raised by clinical
studies in advance of deciding whether to file an IND that suggest safety concerns for all of our product candidates, then FDA could ask us to modify
approved labeling for or withdraw from the market any previously approved products for therapeutic uses or products being commercialized for other non-
drug uses. A decision by the FDA that we cannot conduct clinical studies in advance of filing an IND would significantly impact our current business
model and we may incur significant expense and operational difficulties.
Changes in the legal and regulatory environment could limit our future business activities, increase our operating or regulatory costs, reduce demand
for our product candidates or result in litigation.
The conduct of our business, including the development, testing, production, storage, distribution, sale, display, advertising, marketing, labeling, health and
safety practices, and possible regulatory classification and approval (where necessary) use of many of our product candidates, are subject to various laws
and regulations administered by federal, state and local governmental agencies in the United States, as well as to laws and regulations administered by
government entities and agencies outside the United States in markets in which our products candidates and components thereof (such as packaging) may
be manufactured or sold.
These laws and regulations and interpretations thereof may change, sometimes dramatically, as a result of a variety of factors, including political, economic
or social events. Such changes may include, but are not limited to, changes in:
•
food and drug laws (including FDA regulations);
•
laws related to product candidate labeling;
•
advertising and marketing laws and practices;
•
laws and programs restricting the sale and advertising of certain of product candidates;
•
laws and programs aimed at regulating, restricting or eliminating ingredients present in certain of our product candidates;
•
increased regulatory scrutiny of, and increased litigation involving, product claims and concerns regarding the actual or possible effects or
side effects of ingredients in, or attributes of, certain of our product candidates; and
•
state and federal consumer protection and disclosure laws.
New laws, regulations or governmental policy and their related interpretations, or changes in any of the foregoing, may alter the environment in which we
do business and, therefore, may impact our operating results or increase our costs or liabilities.
Inadequate funding for the FDA, the SEC and other US and non US government agencies could hinder their ability to hire and retain key leadership
and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those
agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
54
The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability
to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have
fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations may rely,
including those that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.
Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government
agencies, which would adversely affect our business. For example, over the last several years, the U.S. government has shut down several times and certain
regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities. If
a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions,
which could have a material adverse effect on our business. Further, in our operations as a public company, future government shutdowns could impact our
ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.
We may rely on academic and private non-academic institutions to conduct investigator-sponsored clinical studies or trials of our product candidates.
Any failure by the investigator-sponsor to meet its obligations with respect to the clinical development of our product candidates may delay or impair
our ability to obtain regulatory approval or commercialize for other product candidates.
We may rely on academic and private non-academic institutions to conduct and sponsor clinical studies or trials relating to our product candidates. We will
not control the design or conduct of the investigator-sponsored trials, and it is possible that the FDA or non-U.S. regulatory authorities will not view these
investigator-sponsored studies or trials as providing adequate support for future clinical trials, whether controlled by us or independent investigators, for
any one or more reasons, including elements of the design or execution of the trials or safety concerns or other trial results.
Such arrangements will likely provide us certain information rights with respect to the investigator-sponsored studies or trials, including access to and the
ability to use and reference the data, including for our own regulatory filings, resulting from the investigator-sponsored studies or trials. However, we
would not have control over the timing and reporting of the data from investigator-sponsored trials, nor would we own the data from the investigator-
sponsored studies or trials. If we are unable to confirm or replicate the results from the investigator-sponsored studies or trials or if negative results are
obtained, we would likely be further delayed or prevented from advancing further clinical development of our product candidates. Further, if investigators
or institutions breach their obligations with respect to the clinical development of our product candidates, or if the data proves to be inadequate compared to
the first-hand knowledge we might have gained had the investigator-sponsored studies or trials been sponsored and conducted by us, then our ability to
design and conduct any future clinical trials ourselves may be adversely affected.
Additionally, the FDA or non-U.S. regulatory authorities may disagree with the sufficiency of our right of reference to the preclinical, manufacturing or
clinical data generated by these investigator-sponsored studies or trials or our interpretation of preclinical, manufacturing or clinical data from these
investigator-sponsored studies or trials. If so, the FDA or other non-U.S. regulatory authorities may require us to obtain and submit additional preclinical,
manufacturing or clinical data before we may initiate our planned clinical trials and/or may not accept such additional data as adequate to initiate our
planned clinical trials. In addition, it could limit or prevent our ability to commercialize product candidates for non-therapeutic uses.
Obtaining and maintaining regulatory approval of our product candidates for therapeutic indications or the ability to commercialize our product
candidates through an alternate regulatory pathway in one jurisdiction does not mean that we will be successful in obtaining regulatory approval or
identifying a similar alternate regulatory pathway for our product candidates in other jurisdictions.
Obtaining and maintaining regulatory approval for therapeutic indications or identifying an alternate regulatory pathway for our product candidates in one
jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval or identify a similar alternate regulatory pathway in any other
jurisdiction, while a failure or delay in obtaining regulatory approval or an alternate regulatory in one jurisdiction may have a negative effect on the
regulatory approval process in others. For example, even if the FDA grants marketing approval of a product
55
candidate for therapeutic indications, comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing and
promotion of the product candidate in those countries. Approval procedures vary among jurisdictions and can involve requirements and administrative
review periods different from, and greater than, those in the United States, including additional preclinical studies, clinical studies and clinical trials
conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a product
candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for
our products is also subject to approval.
Preclinical and clinical development is uncertain. Our preclinical programs, clinical studies and clinical trials may experience delays or may never
advance to the next stage of development, which would adversely affect our ability to obtain regulatory approvals or identify alternate regulatory
pathways to commercialize these programs on a timely basis or at all, which would have an adverse effect on our business.
Our product candidates are in preclinical stages, and their risk of failure is high. To proceed with our development plans and ultimately commercialization,
we may be required to conduct preclinical, clinical studies or clinical trials. For therapeutic applications, the FDA or non-US regulatory authorities may
require additional extensive preclinical studies. We cannot be certain of the timely completion or outcome of our preclinical testing and studies and cannot
predict if the FDA or other regulatory authorities will accept our proposed clinical programs, including the design, dose level, and dose regimen, or if the
outcome of our preclinical testing and studies will ultimately support the further development of our clinical programs for therapeutic indications. As a
result, we cannot be sure that we will be able to submit INDs or similar applications in the case of product candidates for which we pursue a drug pathway
or comply with any other regulatory requirements where necessary for commercialization and marketing of drugs or non-drug products on the timelines we
expect, if at all, and we cannot be sure that submission of INDs or similar applications will result in the FDA or other regulatory authorities allowing
clinical trials to begin, be completed or have their data used to support commercialization and required regulatory approvals. We also cannot be certain if
our testing and studies will provide support for the further development of product candidates as non-drug products or support for any associated product
claims made, and, as a result, we cannot be sure that we will be able to successfully pursue alternative regulatory pathways to commercialization as non-
drug product for some or all of our product candidates.
If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for our product candidates for therapeutic indications, we
will not be able to commercialize, or will be delayed in commercializing, our product candidates, and our ability to generate revenue will be materially
impaired.
Our product candidates and the activities associated with their development and commercialization for therapeutic indications, including their design,
testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale, distribution, import and export are subject to
comprehensive regulation by the FDA and other regulatory agencies in the United States and by comparable authorities in other countries. Before we can
commercialize any of our product candidates for therapeutic indications, we must obtain marketing approval. We have not received approval to market any
of our product candidates from regulatory authorities in any jurisdiction and it is possible that none of our product candidates or any product candidates we
may seek to develop in the future will ever obtain regulatory approval. We, as a company, have no experience in filing and supporting the applications
necessary to gain regulatory approvals for therapeutic indications and expect to rely on third-party CROs and/or regulatory consultants to assist us in this
process. Securing regulatory approval requires the submission of extensive preclinical and clinical data and supporting information to the various
regulatory authorities for each therapeutic indication to establish the drug candidate’s safety and efficacy.
Securing regulatory approval for therapeutic indications also requires the submission of information about the drug manufacturing process to, and
inspection of manufacturing facilities by, the relevant regulatory authority. Our product candidates may not be effective, may be only moderately effective
or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude our obtaining marketing approval or
prevent or limit commercial use.
The process of obtaining regulatory approvals for therapeutic indications, both in the United States and abroad, is expensive, may take many years if
additional clinical trials are required, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity
and novelty of the product candidates involved. Changes in marketing approval policies during the development period, changes in or the enactment of
56
additional statutes or regulations, or changes in regulatory review for each submitted IND, NDA or equivalent application types, may cause delays in the
approval or rejection of an application. The FDA and comparable authorities in other countries have substantial discretion in the approval process and may
refuse to accept any application or may decide that our data are insufficient for approval and require additional preclinical, clinical or other studies. Our
product candidates could be delayed in receiving, or fail to receive, regulatory approval for many reasons, including the following:
•
the FDA or comparable foreign regulatory authorities may disagree with the design, including study population, dose level, dose regimen,
and bioanalytical assay methods, or implementation of our clinical trials;
•
we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a drug candidate is safe and
effective for its proposed indication or a related companion diagnostic is suitable to identify appropriate patient populations;
•
the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities
for approval;
•
we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;
•
the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies, clinical studies or
clinical trials;
•
the data collected from clinical trials of our product candidates may not be sufficient to support the submission of an NDA or other
submission or to obtain regulatory approval in the United States or elsewhere;
•
the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party
manufacturers with which we contract for clinical and commercial supplies; and
•
the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering
our clinical data insufficient for approval.
Of the large number of drugs in development, only a small percentage successfully complete the FDA or foreign regulatory approval processes and are
commercialized. The lengthy approval process as well as the unpredictability of future clinical trial results may result in our failing to obtain regulatory
approval to market our product candidates, which would significantly harm our business, results of operations and prospects.
We expect the novel nature of our product candidates to create further challenges in obtaining regulatory approval. As a result, our ability to develop
product candidates and obtain regulatory approval for therapeutic indications may be significantly impacted.
The FDA may also require a panel of experts, referred to as an Advisory Committee, to deliberate on the adequacy of the safety and efficacy data to
support approval for therapeutic indications. The opinion of the Advisory Committee, although not binding, may have a significant impact on our ability to
obtain approval of any product candidates that we develop based on the completed clinical trials.
In addition, even if we were to obtain approval, regulatory authorities may approve any of our product candidates for fewer or more limited therapeutic
indications than we request, may include limitations for use or contraindications that limit the suitable patient population, may not approve the price we
intend to charge for our products, may grant approval contingent on the performance of costly post-marketing clinical trials or may approve a product
candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. Any
of the foregoing scenarios could materially harm the commercial prospects for our product candidates.
If we experience delays in obtaining approval or if we fail to obtain approval of our product candidates, the commercial prospects for our product
candidates may be harmed and our ability to generate revenues will be materially impaired.
57
Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the
commercial profile of an approved label or result in significant negative consequences following marketing approval, if any.
Undesirable side effects caused by our product candidates could cause us to interrupt, delay or halt preclinical studies or clinical studies or could cause us
or regulatory authorities to interrupt, delay or halt clinical studies or trials and could result in a more restrictive clinical label or the delay or denial of
regulatory approval by the FDA or other regulatory authorities for our product candidates for therapeutic indications. Results of our clinical studies or trials
could reveal a high and unacceptable severity and prevalence of side effects. In such an event, our clinical studies or trials could be suspended or
terminated, and the FDA or comparable foreign regulatory authorities could order us to cease further development of or deny approval of our product
candidates for any or all targeted indications. Additionally, our regulators could require significant modifications or amendments to ongoing clinical studies
or trials that limit the available study population or lead to withdrawal of participation by already enrolled subjects. Any study-related side effects could
affect subject recruitment or the ability of enrolled subjects to complete the study or trial or result in potential product liability claims. Any of these
occurrences may harm our business, financial condition and prospects significantly.
Further, clinical studies or trials by their nature utilize a sample of the potential study population. With a limited number of subjects and limited duration of
exposure, rare and severe side effects of our product candidates may only be uncovered with a significantly larger number of subjects exposed to the
product candidate. If our product candidates receive marketing approval for therapeutic indications and we or others identify undesirable side effects
caused by such product candidates (or any other similar drugs) after such approval, a number of potentially significant negative consequences could result,
up to and including the withdrawal by regulatory authorities of their approval of such product candidate.
Breakthrough Therapy Designation, Fast Track Designation or Rare Pediatric Disease Designation by the FDA, and equivalents granted by other
regulatory authorities, even if granted for any of our product candidates developed for therapeutic indications, may not lead to a faster development,
regulatory review or approval process, and it does not increase the likelihood that any of our product candidates will receive marketing approval in any
jurisdiction.
We may seek a Breakthrough Therapy Designation for some of our product candidates. A breakthrough therapy is defined as a therapy that is intended,
alone or in combination with one or more other therapies, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence
indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as
substantial treatment effects observed early in clinical development. For therapies that have been designated as breakthrough therapies, interaction and
communication between the FDA and the sponsor of the trial can help to identify the most efficient path for clinical development while minimizing the
number of patients placed in ineffective control regimens. Therapies designated as breakthrough therapies by the FDA may also be eligible for priority
review and accelerated approval. Designation as a breakthrough therapy is within the discretion of the FDA. Accordingly, even if we believe one of our
product candidates meets the criteria for designation as a breakthrough therapy, the FDA may disagree and instead determine not to make such designation.
In any event, the receipt of a Breakthrough Therapy Designation for a product candidate may not result in a faster development process, review or approval
compared to therapies considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA. In addition, even if
one or more of our product candidates qualify as breakthrough therapies, the FDA may later decide that such product candidates no longer meet the
conditions for qualification or decide that the time period for FDA review or approval will not be shortened.
We may seek Fast Track Designation for some of our product candidates for therapeutic indications. If a therapy is intended for the treatment of a serious or
life-threatening condition and the therapy demonstrates the potential to address unmet medical needs for this condition, the therapy sponsor may apply for
Fast Track Designation. The FDA has broad discretion whether or not to grant this designation, so even if we believe a particular product candidate is
eligible for this designation; we cannot assure you that the FDA would decide to grant it. Even if we do receive Fast Track Designation, we may not
experience a faster development process, review or approval compared to conventional FDA procedures. The FDA may withdraw Fast Track Designation
if it believes that the designation is no longer supported by data from our clinical development program. Fast Track Designation alone does not guarantee
qualification for the FDA’s priority review procedures.
58
We may seek Rare Pediatric Disease Designation and conditional designation of our marketing application as a “rare pediatric disease product application”
for some of our product candidates for therapeutic indications, which, if granted, could qualify us to receive a Rare Pediatric Priority Review Voucher. The
FDA has broad discretion whether or not to grant this designation, so even if we believe a particular product candidate is eligible for this designation, we
cannot assure you that the FDA would decide to grant it and determination whether to issue such a voucher is made by FDA only at the time of its review
and approval of a marketing application. A Rare Pediatric Priority Review Voucher can be redeemed to receive a priority review of a subsequent marketing
application for a different product.
We may seek priority review designation for one or more of our product candidates for therapeutic indications, but we might not receive such
designation, and even if we do, such designation may not lead to a faster regulatory review or approval process.
If the FDA determines that a product candidate offers a treatment for a serious condition and, if approved, the product would provide a significant
improvement in safety or effectiveness, the FDA may designate the product candidate for priority review. A priority review designation means that the goal
for the FDA to review an application is six months, rather than the standard review period of ten months. We may request priority review for our product
candidates. The FDA has broad discretion with respect to whether or not to grant priority review status to a product candidate, so even if we believe a
particular product candidate is eligible for such designation or status, the FDA may decide not to grant it. Moreover, a priority review designation does not
necessarily result in an expedited regulatory review or approval process or necessarily confer any advantage with respect to approval compared to
conventional FDA procedures. Receiving priority review from the FDA does not guarantee approval within the six-month review cycle or at all.
We may fail to obtain and maintain orphan drug designations from the FDA or the EMA for our current and future therapeutic product candidates, as
applicable.
Our strategy includes filing for orphan drug designation where available for our product candidates for therapeutic indications that are eligible. In the
United States, under the Orphan Drug Act, the FDA may grant orphan drug designation to a drug or biologic intended to treat a rare disease or condition,
which is defined as one occurring in a patient population of fewer than 200,000 in the United States, or a patient population greater than 200,000 in the
United States where there is no reasonable expectation that the cost of developing the drug or biologic will be recovered from sales in the United States. In
the United States, orphan drug designation entitles a party to financial incentives, such as opportunities for grant funding toward clinical trial costs, tax
advantages and user-fee waivers. In addition, if a product that has orphan drug designation subsequently receives the first FDA approval for the disease for
which it has such designation, the product is entitled to orphan drug exclusivity, which means that the FDA may not approve any other applications,
including an NDA, to market the same drug or biologic for the same indication for seven years, except in limited circumstances, such as a showing of
clinical superiority to the product with orphan drug exclusivity or where the original manufacturer is unable to assure sufficient product quantity.
In addition, exclusive marketing rights in the United States may be limited if we seek approval for an indication broader than the orphan-designated
indication or may be lost if the FDA later determines that the request for designation was materially defective or if we are unable to assure sufficient
quantities of the product to meet the needs of patients with the orphan-designated disease or condition. Further, even if we obtain orphan drug exclusivity
for a product, that exclusivity may not effectively protect the product from competition because different drugs with different active moieties may receive
and be approved for the same condition, and only the first applicant to receive approval will receive the benefits of marketing exclusivity. Even after an
orphan-designated product is approved, the FDA can subsequently approve a later drug with the same active moiety for the same condition if the FDA
concludes that the later drug is clinically superior if it is shown to be safer, more effective or makes a major contribution to patient care. Orphan drug
designation neither shortens the development time or regulatory review time of a drug, nor gives the drug any advantage in the regulatory review or
approval process. In addition, while we may seek orphan drug designation for our product candidates, we may never receive such designations.
59
In the European Union, the EMA’s Committee for Orphan Medicinal Products grants orphan drug designation to the development of products that are
intended for the diagnosis, prevention, or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10,000 persons
in the European Union. Additionally, designation is granted for products intended for the diagnosis, prevention, or treatment of a life-threatening, seriously
debilitating or serious and chronic condition when, without incentives, it is unlikely that sales of the drug in the European Union would be sufficient to
justify the necessary investment in developing the drug or biological product or where there is no satisfactory method of diagnosis, prevention, or
treatment, or, if such a method exists, the medicine must be of significant benefit to those affected by the condition.
In the European Union, orphan drug designation entitles a party to financial incentives such as reductions of fees or fee waivers. In addition, ten years of
market exclusivity is granted following drug product approval, meaning that another application for marketing authorization of a later similar medicinal
product for the same indication will generally not be approved in the European Union. This period may be reduced to six years if the orphan designation
criteria are no longer met, including where it is shown that the product is not sufficiently profitable to justify maintenance of market exclusivity. The
market exclusivity period is extended by two additional years for an orphan-designated condition when the results of specific studies are reflected in the
summary of product characteristics addressing the pediatric population and completed in accordance with a fully compliant pediatric investigation plan.
Even if we receive regulatory approval of any product candidates for therapeutic indications, or commercialize our product candidates as non-drug
products, we will be subject to ongoing regulatory compliance obligations or continued regulatory review, which may result in significant additional
expense. Additionally, any of our product candidates, if approved or commercialized, could be subject to labeling and other restrictions and market
withdrawal and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product
candidates.
If any of our product candidates are developed as drug product candidates and approved for therapeutic indications or are commercialized as non-drug
products, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, distribution, quality, safety, sale,
marketing, advertising, promotion, sampling, record-keeping, export, import, conduct of post-marketing studies and submission of safety, efficacy or other
post-market information. Such requirements may be imposed as federal and state requirements in the United States and or by comparable foreign regulatory
authorities. In addition, we will be subject to continued compliance with cGMP requirements as applicable to drugs and non-drug products and GCP
requirements for any clinical trials that we conduct post-approval, if applicable.
The FDA or other regulatory authorities may take regulatory enforcement or other legal action or, in the case of drugs, may impose consent decrees or
withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market.
We also cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action,
either in the United States or abroad. For example, certain policies of the current administration may impact our business and industry. Namely, the current
administration has taken several executive actions, including the issuance of a number of executive orders, that could impose significant burdens on, or
otherwise materially delay, the FDA’s ability to engage in routine regulatory and oversight activities, such as implementing statutes through rulemaking,
issuance of guidance and review and approval of marketing applications. It is difficult to predict how these executive actions, including any executive
orders, will be implemented, and the extent to which they will impact the FDA’s ability to exercise its regulatory authority. If these executive actions
impose constraints on the FDA’s ability to engage in oversight and implementation activities in the normal course, our business may be negatively
impacted. In addition, if we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not
able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, where applicable, our ability to continue to
market and sell our products, and we may not achieve or sustain profitability.
Non-compliance by us or any future collaborator with regulatory requirements, including safety monitoring or pharmacovigilance requirements, where
applicable, can also result in significant financial penalties.
60
Healthcare insurance coverage and reimbursement may be limited or unavailable in certain market segments for our product candidates, if approved,
which could make it difficult for us to sell any product candidates or therapies profitably.
The success of our product candidates, if approved for therapeutic indications, depends on the availability of adequate coverage and reimbursement from
third-party payors. In addition, because our product candidates represent new approaches to the treatment of the diseases they target, we cannot be sure that
coverage and reimbursement will be available for, or accurately estimate the potential revenue from, our product candidates or assure that coverage and
reimbursement will be available for any product that we may develop.
Healthcare insurance often does not cover foods or medical foods administered outside of the hospital setting. This may impact our products if we decide to
commercialize them as medical food, which is required to be administered under medical supervision.
Payors, whether domestic or foreign, or governmental or private, are developing increasingly sophisticated methods of controlling healthcare costs and
those methods are not always specifically adapted for new technologies such as those we are developing.
In both the United States and certain foreign jurisdictions, there have been a number of legislative and regulatory changes to the health care system that
could impact our ability to sell our products profitably. Among policy-makers and payers in the United States and elsewhere, there is significant interest in
promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access to healthcare. In
the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives.
There have been, and likely will continue to be, legislative and regulatory proposals at the federal and state levels directed at broadening the availability of
healthcare and containing or lowering the cost of healthcare. See section entitled “Business – Government Regulation– Current and Future Healthcare
Reform Legislation.”
The continuing efforts of the government, insurance companies, managed care organizations and other payers of healthcare services to contain or reduce
costs of healthcare may adversely affect:
•
the demand for any of our product candidates, if approved;
•
the ability to set a price that we believe is fair for any of our product candidates, if approved;
•
our ability to generate revenues and achieve or maintain profitability;
•
the level of taxes that we are required to pay; and
•
the availability of capital.
Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical
and biologic products. We cannot be sure whether additional legislative changes will be enacted, or whether FDA regulations, guidance or interpretations
will be changed, or what the impact of such changes on the marketing approvals of our product candidates, if any, may be. In addition, increased scrutiny
by Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more stringent product labeling
and post-marketing testing and other requirements.
Moreover, increasing efforts by governmental and third-party payors in the United States and abroad to cap or reduce healthcare costs may cause such
organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate
payment for our product candidates. There has been increasing legislative and enforcement interest in the United States with respect to specialty drug
pricing practices. Specifically, there have been several recent U.S. Congressional inquiries and proposed and enacted federal and state legislation designed
to, among other things, bring more transparency to drug
61
pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform
government program reimbursement methodologies for drugs.
We expect that the healthcare reform measures that have been adopted and may be adopted in the future, may result in more rigorous coverage criteria and
in additional downward pressure on the price that we receive for any approved product and could seriously harm our future revenues. Any reduction in
reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of
cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercialize our
products.
European Union drug marketing and reimbursement regulations may materially affect our ability to market and receive coverage for our therapeutic
products in the European member states.
We may seek approval to market our product candidates in both the United States and in selected foreign jurisdictions. If we obtain approval in one or more
foreign jurisdictions for our product candidates, we will be subject to rules and regulations in those jurisdictions. In some foreign countries, particularly
those in the European Union, the pricing of pharmaceutical products is subject to governmental control and other market regulations which could put
pressure on the pricing and usage of our product candidates. In these countries, pricing negotiations with governmental authorities can take considerable
time after obtaining marketing approval of a product candidate. In addition, market acceptance and sales of our product candidates will depend significantly
on the availability of adequate coverage and reimbursement from third-party payors for our product candidates and may be affected by existing and future
healthcare reform measures. In some countries, we may also be required to conduct a clinical trial or other studies that compare the cost-effectiveness of
any of our product candidates to other available therapies in order to obtain or maintain reimbursement or pricing approval. There can be no assurance that
any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements
for any of our products.
Much like the Anti-Kickback Statute prohibition in the United States, the provision of benefits or advantages to physicians to induce or encourage the
prescription, recommendation, endorsement, purchase, supply, order or use of medicinal products is also prohibited in the European Union. The provision
of benefits or advantages to physicians is governed by the national anti-bribery laws of European Union Member States, such as the UK Bribery Act 2010.
Infringement of these laws could result in substantial fines and imprisonment.
Payments made to physicians in certain European Union Member States must be publicly disclosed. Moreover, agreements with physicians often must be
the subject of prior notification and approval by the physician’s employer, his or her competent professional organization and/or the regulatory authorities
of the individual European Union Member States. These requirements are provided in the national laws, industry codes or professional codes of conduct,
applicable in the European Union Member States. Failure to comply with these requirements could result in reputational risk, public reprimands,
administrative penalties, fines or imprisonment.
Failure to comply with health and data protection laws and regulations could lead to government enforcement actions (which could include civil or
criminal penalties), private litigation or adverse publicity and could negatively affect our operating results and business.
We and any potential collaborators may be subject to federal, state and foreign data protection laws and regulations (i.e., laws and regulations that address
privacy and data security). In the United States, numerous federal and state laws and regulations, including federal health information privacy laws, state
data breach notification laws, state health information privacy laws and federal and state consumer protection laws (e.g., Section 5 of the Federal Trade
Commission Act), that govern the collection, use, disclosure and protection of health-related and other personal information could apply to our operations
or the operations of our collaborators. For instance, California recently enacted the California Consumer Privacy Act, or CCPA, which creates new
individual privacy rights for California consumers (as defined in the law) and places increased privacy and security obligations on entities handling
personal data of consumers or households. The CCPA requires covered companies to provide certain disclosures to consumers about its data collection, use
and sharing practices, and to provide affected California residents with ways
62
to opt-out of certain sales or transfers of personal information. The CCPA went into effect on January 1, 2020, and the California Attorney General
commenced enforcement actions against violators beginning July 1, 2020. As currently written, the CCPA may impact our business activities; however,
there continues to be uncertainty about how the law will be interpreted and enforced. The uncertainty surrounding the implementation of CCPA exemplifies
the vulnerability of our business to the evolving regulatory environment related to personal data and protected health information.
In addition, we may obtain health information from third parties (including research institutions from which we obtain Clinical Trial data) that are subject
to privacy and security requirements under HIPAA, as amended by HITECH. Depending on the facts and circumstances, we could be subject to civil,
criminal and administrative penalties if we knowingly obtain, use or disclose individually identifiable health information maintained by a HIPAA-covered
entity in a manner that is not authorized or permitted by HIPAA. HIPAA requires covered entities and business associates to develop and maintain policies
and procedures with respect to Protected Health Information, or PHI, that is used or disclosed, including the adoption of administrative, physical and
technical safeguards to protect such information and ensure the confidentiality, integrity and availability of electronic PHI. HIPAA also implemented the
use of standard transaction code sets and standard identifiers that covered entities must use when submitting or receiving certain electronic healthcare
transactions, including activities associated with the billing and collection of healthcare claims. The United States Office of Civil Rights may impose
penalties on a covered entity for a failure to comply with a requirement of HIPAA. Penalties will vary significantly depending on factors such as the date of
the violation, whether the covered entity knew or should have known of the failure to comply, or whether the covered entity’s failure to comply was due to
willful neglect. These penalties include significant civil monetary penalties, criminal penalties and, in certain instances, imprisonment. HIPAA also
authorizes state attorneys general to file suit on behalf of their residents. Courts may award damages, costs and attorneys’ fees related to violations of
HIPAA in such cases. While HIPAA does not create a private right of action allowing individuals to sue us in civil court for violations of HIPAA, its
standards have been used as the basis for duty of care in state civil suits such as those for negligence or recklessness in the misuse or breach of PHI.
Furthermore, in the event of a breach as defined by HIPAA, the covered entity has specific reporting requirements under HIPAA regulations. In the event of
a significant breach, the reporting requirements could include notification to the general public. Enforcement activity can result in reputational harm, and
responses to such enforcement activity can consume significant internal resources. Additionally, if we are unable to properly protect the privacy and
security of PHI, we could be found to have breached our contracts. Determining whether PHI has been handled in compliance with applicable privacy
standards and our contractual obligations can be complex and we cannot be sure how these regulations will be interpreted, enforced or applied to our
operations.
Compliance with U.S. and international data protection laws and regulations could require us to take on more onerous obligations in our contracts, restrict
our ability to collect, use and disclose data or, in some cases, impact our ability to operate in certain jurisdictions. Failure to comply with these laws and
regulations could result in government enforcement actions (which could include civil, criminal and administrative penalties), private litigation or adverse
publicity and could negatively affect our operating results and business. Moreover, clinical study and clinical trial subjects, employees and other individuals
about whom we or our potential collaborators obtain personal information, as well as the providers who share this information with us, may limit our
ability to collect, use and disclose the information. Claims that we have violated individuals' privacy rights, failed to comply with data protection laws, or
breached our contractual obligations, even if we are not found liable, could be expensive and time-consuming to defend and could result in adverse
publicity that could harm our business.
European data collection is governed by restrictive regulations governing the use, processing, and cross-border transfer of personal information.
The collection and use of personal health data in the European Union is governed by the provisions of the Data Protection Directive, and as of May 2018
the GDPR. These directives impose several requirements relating to the consent of the individuals to whom the personal data relates, the information
provided to the individuals, notification of data processing obligations to the competent national data protection authorities and the security and
confidentiality of the personal data. The Data Protection Directive and GDPR also impose strict rules on the transfer of personal data out of the European
Union to the United States. Failure to comply with the requirements of the Data Protection Directive, the GDPR, and the related national data protection
laws of the European Union Member States may result in fines and other administrative penalties. The GDPR introduces new data protection requirements
in the European Union and substantial fines for breaches of the data protection rules. The GDPR regulations may impose additional responsibility and
liability in relation to personal data that we process, and we may be required to put in
63
place additional mechanisms ensuring compliance with the new data protection rules. This may be onerous and adversely affect our business, financial
condition, results of operations and prospects.
Following the U.K.’s withdrawal from the European Union on January 31, 2020, the GDPR ceased to apply in the United Kingdom at the end of the
transition period on December 31, 2020. However, as of January 1, 2021, the United Kingdom’s European Union (Withdrawal) Act 2018 incorporated the
GDPR (as it existed on December 31, 2020 but subject to certain UK specific amendments) into United Kingdom law (referred to as the ‘UK GDPR’). The
UK GDPR and the UK Data Protection Act 2018 set out the UK’s data protection regime, which is independent from but aligned to the European Union’s
data protection regime. Non-compliance with the UK GDPR may result in monetary penalties of up to £17.5 million or 4% of worldwide revenue,
whichever is higher. Although the United Kingdom is regarded as a third country under the EU GDPR, the European Commission has now issued a
decision recognizing the United Kingdom as providing adequate protection under the EU GDPR and, therefore, transfers of personal data originating in the
EEA to the United Kingdom remain unrestricted. Like the EU GDPR, the UK GDPR restricts personal data transfers outside the United Kingdom to
countries not regarded by the United Kingdom as providing adequate protection. The United Kingdom government has confirmed that personal data
transfers from the United Kingdom to the European Economic Area remain free flowing.
64
Laws and regulations governing any international operations we may have in the future may preclude us from developing, manufacturing and selling
certain products outside of the United States and require us to develop and implement costly compliance programs.
If we expand our operations outside of the United States, we must dedicate additional resources to comply with numerous laws and regulations in each
jurisdiction in which we plan to operate. The FCPA prohibits any U.S. individual or business from paying, offering, authorizing payment or offering of
anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of the foreign
entity in order to assist the individual or business in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the
United States to comply with certain accounting provisions requiring the company to maintain books and records that accurately and fairly reflect all
transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for
international operations.
Compliance with the FCPA is expensive and difficult, particularly in countries in which corruption is a recognized problem. In addition, the FCPA presents
particular challenges in the pharmaceutical industry, because, in many countries, hospitals are operated by the government, and doctors and other hospital
employees are considered foreign officials. Certain payments to hospitals in connection with clinical trials and other work have been deemed to be
improper payments to government officials and have led to FCPA enforcement actions.
Various laws, regulations and executive orders also restrict the use and dissemination outside of the United States, or the sharing with certain non-U.S.
nationals, of information classified for national security purposes, as well as certain products and technical data relating to those products. If we expand our
presence outside of the United States, it will require us to dedicate additional resources to comply with these laws, and these laws may preclude us from
developing, manufacturing, or selling certain products and product candidates outside of the United States, which could limit our growth potential and
increase our development costs.
The failure to comply with laws governing international business practices may result in substantial civil and criminal penalties and suspension or
debarment from government contracting. The SEC also may suspend or bar issuers from trading securities on U.S. exchanges for violations of the FCPA’s
accounting provisions.
We are subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations. We
can face serious consequences for violations.
Among other matters, U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations, which are
collectively referred to as Trade Laws, prohibit companies and their employees, agents, clinical research organizations, legal counsel, accountants,
consultants, contractors, and other partners from authorizing, promising, offering, providing, soliciting, or receiving directly or indirectly, corrupt or
improper payments or anything else of value to or from recipients in the public or private sector. Violations of Trade Laws can result in substantial criminal
fines and civil penalties, imprisonment, the loss of trade privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm,
and other consequences. We have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals,
universities, and other organizations. We also expect our non-U.S. activities to increase in time. We plan to engage third parties for clinical trials and/or to
obtain necessary permits, licenses, patent registrations, and other regulatory approvals and we can be held liable for the corrupt or other illegal activities of
our personnel, agents, or partners, even if we do not explicitly authorize or have prior knowledge of such activities.
Changes in funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other
personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from
performing normal functions on which the operation of our business may rely, which could negatively impact our business.
The ability of the FDA to review and approve new products or take action with respect to other regulatory matters can be affected by a variety of factors,
including government budget and funding levels, ability to hire and retain key personnel and accept payment of user fees and statutory, regulatory and
policy changes. Average review times at the
65
agency have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations may
rely, including those that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.
Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed or approved, or for other actions to be taken, by
relevant government agencies, which would adversely affect our business. For example, over the last several years, the U.S. government has shut down
several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and
stop critical activities. If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our
regulatory submissions, which could have a material adverse effect on our business. Similarly, a prolonged government shutdown could prevent the timely
review of our patent applications by the United States Patent and Trademark Office, or USPTO, which could delay the issuance of any U.S. patents to
which we might otherwise be entitled. Further, in our operations as a public company, future government shutdowns could impact our ability to access the
public markets and obtain necessary capital in order to properly execute our business plans.
66
Risks related to our intellectual property
If we are unable to obtain and maintain patent protection for any product candidates we develop or for our proprietary product platform, our
competitors could develop and commercialize products or technology similar or identical to ours, and our ability to successfully commercialize any
product candidates we may develop, and our technology may be adversely affected.
Our success depends in large part on our ability to obtain and maintain patent protection in the United States and other countries with respect to our product
candidates, proprietary product platform and other technologies we may develop. We seek to protect our proprietary position by filing patent applications in
the United States and abroad relating to our product candidates and proprietary product platform, as well as other technologies that are important to our
business. Given that the development of our technology and product candidates is at an early stage, our intellectual property portfolio with respect to
certain aspects of our technology and product candidates is also at an early stage. We have filed or intend to file patent applications on these aspects of our
technology and our product candidates; however, there can be no assurance that any such patent applications will issue as granted patents. Furthermore, in
some cases, we have only filed provisional patent applications on certain aspects of our technology and product candidates and each of these provisional
patent applications is not eligible to become an issued patent until, among other things, we file a non-provisional patent application within 12 months of the
filing date of the applicable provisional patent application. Any failure to file a non-provisional patent application within this timeline could cause us to
lose the ability to obtain patent protection for the inventions disclosed in the associated provisional patent applications.
Composition of matter patents for biological and pharmaceutical products are generally considered to be the strongest form of intellectual property
protection for those types of products, as such patents provide protection without regard to any method of use. We cannot be certain, however, that the
claims in our pending patent applications covering the composition of matter of our product candidates will be considered patentable by the USPTO or by
patent offices in foreign countries, or that the claims in any of our issued patents will be considered valid and enforceable by courts in the United States or
foreign countries. Furthermore, in some cases, we may not be able to obtain issued claims covering compositions of matter relating to our product
candidates and proprietary product platform, as well as other technologies that are important to our business, and instead may need to rely on filing patent
applications with claims covering a method of use and/or method of manufacture. Method of use patents protect the use of a product for the specified
method. This type of patent does not prevent a competitor from making and marketing a product that is identical to our product for an indication that is
outside the scope of the patented method. Moreover, even if competitors do not actively promote their products for our targeted indications, physicians may
prescribe these products “off-label” for those uses that are covered by our method of use patents. Although off-label prescriptions may infringe or
contribute to the infringement of method of use patents, the practice is common and such infringement is difficult to prevent or prosecute. There can be no
assurance that any such patent applications will issue as granted patents, and even if they do issue, such patent claims may be insufficient to prevent third
parties, such as our competitors, from utilizing our technology. Any failure to obtain or maintain patent protection with respect to our product candidates
and proprietary product platform could have a material adverse effect on our business, financial condition, results of operations, and prospects.
If any of our owned patent applications do not issue as patents in any jurisdiction, we may not be able to compete effectively.
Changes in either the patent laws or their interpretation in the United States and other countries may diminish our ability to protect our inventions, obtain,
maintain, and enforce our intellectual property rights and, more generally, could affect the value of our intellectual property or narrow the scope of our
owned patents. With respect to our patent portfolio, as of March 31, 2021, our patent portfolio in total consisted of fifteen issued U.S. patents, four issued
European patents, twenty-two issued patents in other jurisdictions (Argentina, Australia, Brazil, Canada, China, Colombia, Hong Kong, India, Indonesia,
Israel, Malaysia, Mexico, New Zealand, Philippines, Singapore and South Africa), and approximately 115 pending non-provisional applications (U.S., EP
and other jurisdictions), which include claims directed to compositions, methods of use, and manufacturing processes. With respect to owned intellectual
property, we cannot predict whether the patent applications we are currently pursuing will issue as patents in any particular jurisdiction or whether the
claims of any issued patents will provide sufficient protection from competitors or other third parties.
67
The patent prosecution process is expensive, time-consuming, and complex, and we may not be able to file, prosecute, maintain, enforce, or license all
necessary or desirable patents and patent applications at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable
aspects of our research and development output in time to obtain patent protection. Although we enter into non-disclosure and confidentiality agreements
with parties who have access to confidential or patentable aspects of our research and development output, such as our employees, corporate collaborators,
outside scientific collaborators, CROs, contract manufacturers, consultants, advisors and other third parties, any of these parties may breach such
agreements and disclose such output before a patent application is filed, thereby jeopardizing our ability to seek patent protection. In addition, our ability to
obtain and maintain valid and enforceable patents depends on whether the differences between our inventions and the prior art allow our inventions to be
patentable over the prior art. Furthermore, publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent
applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, we
cannot be certain that we were the first to make the inventions claimed in any of our owned or pending patent applications, or that we were the first to file
for patent protection of such inventions.
If the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors
from commercializing similar or identical technology and product candidates would be adversely affected.
The patent position of healthcare companies generally is highly uncertain, involves complex legal and factual questions, and has been the subject of much
litigation in recent years. As a result, the issuance, scope, validity, enforceability, and commercial value of our patent rights are highly uncertain. Our
owned pending and future patent applications may not result in patents being issued which protect our product candidates, proprietary product platform
technology, or other technologies or which effectively prevent others from commercializing competitive technologies and product candidates.
No consistent policy regarding the scope of claims allowable in patents in the biotechnology field has emerged in the United States. The patent situation
outside of the United States is even more uncertain. Changes in either the patent laws or their interpretation in the United States and other countries may
diminish our ability to protect our inventions and enforce our intellectual property rights, and more generally could affect the value of our intellectual
property. In particular, our ability to stop third parties from making, using, selling, offering to sell, or importing products that infringe our intellectual
property will depend in part on our success in obtaining and enforcing patent claims that cover our technology, inventions and improvements. With respect
to company-owned intellectual property, we cannot be sure that patents will be granted with respect to any of our pending patent applications or with
respect to any patent applications filed by us in the future, nor can we be sure that any of our existing patents or any patents that may be granted to us in the
future will be commercially useful in protecting our products and the methods used to manufacture those products. Moreover, even our issued patents do
not guarantee us the right to practice our technology in relation to the commercialization of our products. The area of patent and other intellectual property
rights in biotechnology is an evolving one with many risks and uncertainties, and third parties may have blocking patents that could be used to prevent us
from commercializing our patented product candidates and practicing our proprietary technology. Our issued patents and those that may issue in the future
may be challenged, invalidated, or circumvented, which could limit our ability to stop competitors from marketing related products or limit the length of
the term of patent protection that we may have for our product candidates. In addition, the rights granted under any issued patents may not provide us with
protection or competitive advantages against competitors with similar technology. Furthermore, our competitors may independently develop similar
technologies. For these reasons, we may have competition for our product candidates. Moreover, because of the extensive time required for development,
testing and regulatory review of a potential product, it is possible that, before any particular product candidate can be commercialized, any related patent
may expire or remain in force for only a short period following commercialization, thereby reducing any advantage of the patent.
Moreover, the coverage claimed in a patent application can be significantly reduced before the patent is issued, and its scope can be reinterpreted after
issuance. Even if patent applications we own issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent
competitors or other third parties from competing with us, or otherwise provide us with any competitive advantage. Any patents that we own may be
challenged, narrowed, circumvented, or invalidated by third parties. Consequently, we do not know whether our product candidates or other technologies
will be protectable or remain protected by valid and enforceable patents. Our competitors or other third parties may be able to circumvent our patents by
developing similar or alternative technologies or products in a non-infringing manner which could materially adversely affect our business, financial
condition, results of operations and prospects.
68
The issuance of a patent is not conclusive as to its inventorship, scope, validity, or enforceability, and patents that we own may be challenged in the courts
or patent offices in the United States and abroad. We may be subject to a third party preissuance submission of prior art to the USPTO or to foreign patent
authorities or become involved in opposition, derivation, revocation, reexamination, post-grant and inter partes review, or interference proceedings or other
similar proceedings challenging our owned patent rights. An adverse determination in any such submission, proceeding or litigation could reduce the scope
of, or invalidate or render unenforceable, our owned patent rights, allow third parties to commercialize our product candidates, proprietary product platform
technologies or other technologies and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products
without infringing third-party patent rights. Moreover, we may have to participate in interference proceedings declared by the USPTO to determine priority
of invention or in post-grant challenge proceedings, such as oppositions in a foreign patent office, that challenge our priority of invention or other features
of patentability with respect to our owned patents and patent applications. Such challenges may result in loss of patent rights, loss of exclusivity, or in
patent claims being narrowed, invalidated, or held unenforceable, which could limit our ability to stop others from using or commercializing similar or
identical technology and products, or limit the duration of the patent protection of our product candidates, proprietary product platform and other
technologies. Such proceedings also may result in substantial cost and require significant time from our scientists and management, even if the eventual
outcome is favorable to us.
In addition, given the amount of time required for the development, testing, and regulatory review of new product candidates, patents protecting such
product candidates might expire before or shortly after such product candidates are commercialized. As a result, our intellectual property may not provide
us with sufficient rights to exclude others from commercializing products similar or identical to ours.
We may in the future co-own patent rights relating to future product candidates and our proprietary product platform with third parties. We may need the
cooperation of any such co-owners of our patent rights in order to enforce such patent rights against third parties, and such cooperation may not be
provided to us. Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of operations,
and prospects.
Our rights to develop and commercialize our product candidates and proprietary product platform may be subject, in part, to the terms and conditions
of future licenses granted to us by others.
We may rely upon licenses to certain patent rights and proprietary technology from third parties that are important or necessary to the development of our
product candidates and proprietary product platform. Patent rights that we in-license in the future may be subject to a reservation of rights by one or more
third parties. As a result, any such third parties may have certain rights to such intellectual property.
In addition, subject to the terms of any such license agreements, we may not have the right to control the preparation, filing, prosecution and maintenance,
and we may not have the right to control the enforcement, and defense of patents and patent applications covering the technology that we license from third
parties. We cannot be certain that our in-licensed patent applications (and any patents issuing therefrom) that are controlled by our licensors will be
prepared, filed, prosecuted, maintained, enforced, and defended in a manner consistent with the best interests of our business. If our licensors fail to
prosecute, maintain, enforce, and defend such patents rights, or lose rights to those patent applications (or any patents issuing therefrom), the rights we
have licensed may be reduced or eliminated, our right to develop and commercialize any of our product candidates and proprietary product platform
technologies that are subject of such licensed rights could be adversely affected, and we may not be able to prevent competitors from making, using and
selling competing products. Moreover, we cannot be certain that such activities by our potential future licensors will be conducted in compliance with
applicable laws and regulations or will result in valid and enforceable patents or other intellectual property rights. In addition, even where we may have the
right to control patent prosecution of patents and patent applications that we may license to and from third parties, we may still be adversely affected or
prejudiced by actions or inactions of our potential future licensees, licensors and their counsel that took place prior to the date of assumption of control over
patent prosecution.
69
We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.
Filing, prosecuting and defending patents on our product candidates, proprietary product platform technologies and other technologies in all countries
throughout the world would be prohibitively expensive, and the laws of foreign countries may not protect our rights to the same extent as the laws of the
United States. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from
selling or importing products made using our inventions in and into the United States or other jurisdictions. Competitors may use our technologies in
jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to
territories where we have patent protection, but enforcement is not as strong as that in the United States. These products may compete with our products,
and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.
Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems
of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets, and other intellectual property
protection, particularly those relating to biotechnology products, which could make it difficult for us to stop the infringement of our patents or marketing of
competing products in violation of our intellectual property and proprietary rights generally. Proceedings to enforce our intellectual property and
proprietary rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put
our patents at risk of being invalidated or interpreted narrowly, could put our patent applications at risk of not issuing, and could provoke third parties to
assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially
meaningful. Accordingly, our efforts to enforce our intellectual property and proprietary rights around the world may be inadequate to obtain a significant
commercial advantage from the intellectual property that we develop or license.
Many countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In addition, many
countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited
remedies, which could materially diminish the value of such patent. If we are forced to grant a license to third parties with respect to any patents relevant to
our business, our competitive position may be impaired, and our business, financial condition, results of operations, and prospects may be adversely
affected.
Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other
requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these
requirements.
Periodic maintenance fees, renewal fees, annuity fees, and various other government fees on patents and applications will be due to be paid to the USPTO
and various government patent agencies outside of the United States over the lifetime of our owned patents and applications. The USPTO and various non-
U.S. government agencies require compliance with several procedural, documentary, fee payment, and other similar provisions during the patent
application process. In some cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules.
There are situations, however, in which non-compliance can result in abandonment or lapse of the patent or patent application, resulting in a partial or
complete loss of patent rights in the relevant jurisdiction. In such an event, potential competitors might be able to enter the market with similar or identical
products or technology, which could have a material adverse effect on our business, financial condition, results of operations, and prospects.
Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.
Changes in either the patent laws or interpretation of the patent laws in the United States could increase the uncertainties and costs surrounding the
prosecution of patent applications and the enforcement or defense of issued patents. Assuming that other requirements for patentability are met, prior to
March 2013, in the United States, the first to invent the claimed invention was entitled to the patent, while outside the United States, the first to file a patent
application was entitled to the patent. After March 2013, under the Leahy-Smith America Invents Act, or the America Invents Act, enacted in September
2011, the United States transitioned to a first inventor to file system in
70
which, assuming that other requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention
regardless of whether a third party was the first to invent the claimed invention. A third party that files a patent application in the USPTO after March 2013,
but before us could therefore be awarded a patent covering an invention of ours even if we had made the invention before it was made by such third party.
This will require us to be cognizant going forward of the time from invention to filing of a patent application. Since patent applications in the United States
and most other countries are confidential for a period of time after filing or until issuance, we cannot be certain that we were the first to file any patent
application related to our product candidates, proprietary product platform or other technologies.
The America Invents Act also includes a number of significant changes that affect the way patent applications will be prosecuted and also may affect patent
litigation. These include allowing third party submission of prior art to the USPTO during patent prosecution and additional procedures to attack the
validity of a patent by USPTO administered post-grant proceedings, including post-grant review, inter partes review, and derivation proceedings. Because
of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in United States federal courts necessary to invalidate a patent
claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same
evidence would be insufficient to invalidate the claim if first presented in a district court action. Accordingly, a third party may attempt to use the USPTO
procedures to invalidate our patent claims that would not have been invalidated if first challenged by the third party as a defendant in a district court action.
Therefore, the America Invents Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our owned patent
applications and the enforcement or defense of our owned issued patents, all of which could have a material adverse effect on our business, financial
condition, results of operations, and prospects.
In addition, the patent positions of companies in the development and commercialization of biologics and pharmaceuticals are particularly uncertain.
Recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent
owners in certain situations. This combination of events has created uncertainty with respect to the validity and enforceability of patents, once obtained.
Depending on future actions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in
unpredictable ways that could have a material adverse effect on our existing patent portfolio and our ability to protect and enforce our intellectual property
in the future.
Issued patents covering our product candidates, and any patents that may issue covering our proprietary product platform technologies and other
technologies, could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad.
If we or any of our third-party licensees, such as Midori Animal Health, which holds an exclusive license to certain of our patents in the field of non-human
animal health, initiated legal proceedings against a third party to enforce a patent covering our product candidates, proprietary product platform
technologies or other technologies, the defendant could counterclaim that such patent is invalid or unenforceable. In patent litigation in the United States,
defendant counterclaims alleging invalidity or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any
of several statutory requirements, including lack of novelty, obviousness or non-enablement. Grounds for an unenforceability assertion could be an
allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during
prosecution. Third parties may raise claims challenging the validity or enforceability of our owned patents before administrative bodies in the United States
or abroad, even outside the context of litigation. Such mechanisms include re-examination, post-grant review, inter partes review, interference proceedings,
derivation proceedings, and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). Such proceedings could result in the revocation
of, cancellation of, or amendment to our patents in such a way that they no longer cover our product candidates, proprietary product platform technologies,
or other technologies. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity question, for
example, we cannot be certain that there is no invalidating prior art, of which we and the patent examiner were unaware during prosecution. If a third party
were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our product
candidates, proprietary product platform or other technologies. Such a loss of patent protection would have a material adverse impact on our business,
financial condition, results of operations, and prospects.
71
If we do not obtain patent term extension and/or data exclusivity for any product candidates we may develop, our business may be materially harmed.
Depending upon the timing, duration and specifics of any FDA marketing approval of any product candidates we may develop, one or more of our owned
U.S. patents may be eligible for limited patent term extension under the Hatch-Waxman Act. The Hatch-Waxman Act permits a patent term extension of up
to five years as compensation for patent term lost during the FDA regulatory review process. A patent term extension cannot extend the remaining term of a
patent beyond a total of 14 years from the date of product approval, only one patent may be extended and only those claims covering the approved drug, a
method for using it, or a method for manufacturing it may be extended. Similar extensions as compensation for patent term lost during regulatory review
processes are also available in certain foreign countries and territories, such as in Europe under a Supplementary Patent Certificate. However, we may not
be granted an extension in the United States and/or foreign countries and territories because of, for example, failing to exercise due diligence during the
testing phase or regulatory review process, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents, or otherwise
failing to satisfy applicable requirements. Moreover, the applicable time period or the scope of patent protection afforded could be less than we request. If
we are unable to obtain patent term extension or the term of any such extension is shorter than what we request, our competitors may obtain approval of
competing products following our patent expiration, and our business, financial condition, results of operations and prospects could be materially harmed.
We may be subject to claims challenging the inventorship of our patents and other intellectual property.
We may be subject to claims that former employees, collaborators or other third parties have an interest in our owned patent rights, trade secrets, or other
intellectual property as an inventor or co-inventor. For example, we may have inventorship disputes arise from conflicting obligations of employees,
consultants or others who are involved in developing our product candidates, proprietary product platform or other technologies. Litigation may be
necessary to defend against these and other claims challenging inventorship or our ownership of our owned patent rights, trade secrets or other intellectual
property. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as
exclusive ownership of, or right to use, intellectual property that is important to our product candidates, proprietary product platform and other
technologies. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and
other employees. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.
If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
In addition to seeking patents for our product candidates, proprietary product platform and other technologies, we also rely on trade secrets and
confidentiality agreements to protect our unpatented know-how, technology, and other proprietary information and to maintain our competitive position.
Trade secrets and know-how can be difficult to protect. We expect our trade secrets and know-how to over time be disseminated within the industry
through independent development, the publication of journal articles describing the methodology, and the movement of personnel from academic to
industry scientific positions.
We currently, and may continue in the future, rely on third parties to assist us in developing and manufacturing our product candidates. Accordingly, we
must, at times, share know-how and trade secrets, including those related to our proprietary product platform, with them. We may in the future also enter
into research and development collaborations with third parties that may require us to share know-how and trade secrets under the terms of our research and
development partnerships or similar agreements. We seek to protect our know-how, trade secrets and other proprietary technology, in part, by entering into
non-disclosure and confidentiality agreements, and including in our vendor and service agreements terms protecting our confidential information, know-
how and trade secrets, with parties who have access to such information, such as our employees, scientific collaborators, CROs, contract manufacturers,
consultants, advisors and other third parties. We also enter into confidentiality and invention or patent assignment agreements with our employees and
consultants as well as train our employees not to bring or use proprietary information or technology from former employers to us or in their work, and we
remind former employees when they leave their employment of their confidentiality obligations. However, we cannot guarantee that we have entered into
such agreements with each party that may have or have had access to our trade secrets or proprietary technology and processes. We also seek to preserve
the integrity and confidentiality of our data and other confidential information by maintaining physical security of our premises and physical and electronic
security of our information technology systems.
72
Despite our efforts, any of the aforementioned parties may breach the agreements and disclose our proprietary information, including our trade secrets, or
there may be a lapses or failures in our physical and electronic security systems which lead to our proprietary information being disclosed, and we may not
be able to obtain adequate remedies in the event of any such breaches. Monitoring unauthorized uses and disclosures is difficult, and we do not know
whether the steps we have taken to protect our proprietary technologies will be effective. If any of our scientific advisors, employees, contractors and
consultants who are parties to these agreements breaches or violates the terms of any of these agreements, we may not have adequate remedies for any such
breach or violation, and we could lose our trade secrets as a result. Moreover, if confidential information that is licensed or disclosed to us by our partners,
collaborators, or others is inadvertently disclosed or subject to a breach or violation, we may be exposed to liability to the owner of that confidential
information. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive, and time-consuming, and the
outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets. If any of our
trade secrets were to be lawfully obtained or independently developed by a competitor or other third party, we would have no right to prevent them from
using that technology or information to compete with us. If any of our trade secrets were to be disclosed to or independently developed by a competitor or
other third party, our competitive position would be materially and adversely harmed.
We rely on our proprietary product platform to identify microbiome therapies. Our competitive position could be materially harmed if our competitors
develop a similar platform and develop rival product candidates.
We rely on know-how, inventions and other proprietary information, to strengthen our competitive position. We consider know-how to be our primary
intellectual property with respect to our proprietary product platform. Our clinical trials allow us to collect clinical data, which we use as a feedback loop to
make improvements to our proprietary product platform. In particular, we anticipate that, with respect to the proprietary product platform, these data may
over time be disseminated within the industry through independent development, the publication of journal articles describing the method, and the
movement of skilled personnel.
We cannot rule out that our competitors may have or obtain the knowledge necessary to analyze and characterize similar data to our own data for the
purpose of identifying and developing products that could compete with any of our product candidates. Our competitors may also have significantly greater
financial, product development, technical, and human resources and access to date. Further, our competitors may have significantly greater experience in
using translational science methods to identify and develop product candidates.
We may not be able to prohibit our competitors from using technology or methods that are the same as or similar to our proprietary product platform to
develop their own product candidates. If our competitors develop associated therapies, our ability to develop and market a promising product or product
candidate may diminish substantially, which could have a material adverse effect on our business, financial condition, prospects and results of operations.
We may not be successful in obtaining, through acquisitions, in-licenses or otherwise, necessary rights to our product candidates, proprietary product
platform technologies or other technologies.
We currently have rights to certain intellectual property, through licenses from third parties, to develop our product candidates and proprietary product
platform technologies. Some healthcare companies and academic institutions are competing with us in the field of microbiome therapies and may have
patents and have filed and are likely filing patent applications potentially relevant to our business. In order to avoid infringing these third-party patents, we
may find it necessary or prudent to obtain licenses to such patents from such third-party intellectual property holders. We may also require licenses from
third parties for certain technologies that we may evaluate for use with our current or future product candidates. However, we may be unable to secure such
licenses or otherwise acquire or in-license any compositions, methods of use, processes, or other intellectual property rights from third parties that we
identify as necessary for our current or future product candidates and our proprietary product platform at a reasonable cost or on reasonable terms, if at all.
The licensing or acquisition of third-party intellectual property rights is a competitive area, and several more established companies may pursue strategies
to license or acquire third party intellectual property rights that we may consider attractive or necessary. These established companies may have a
competitive advantage over us due to their size, capital resources and greater clinical development and commercialization capabilities. In addition,
companies that perceive us to be a competitor may be unwilling to assign or license rights to us. We also may be unable to license or acquire third party
intellectual property rights on terms that would allow us to make an appropriate return on our investment or at all.
73
In the event that we try to obtain rights to required third party intellectual property rights, and are ultimately unsuccessful, we may be required to expend
significant time and resources to redesign our technology, product candidates, or the methods for manufacturing them or to develop or license replacement
technology, all of which may not be feasible on a technical or commercial basis. If we are unable to do so, we may be unable to develop or commercialize
the affected product candidates or continue to utilize our existing proprietary product platform technology, which could harm our business, financial
condition, results of operations, and prospects significantly.
We may be subject to claims that our employees, consultants, or advisors have wrongfully used or disclosed alleged trade secrets of their current or
former employers or claims asserting ownership of what we regard as our own intellectual property.
Many of our employees, consultants, and advisors are currently or were previously employed at universities or other healthcare companies, including our
competitors and potential competitors. Although we try to ensure that our employees, consultants, and advisors do not use the proprietary information or
know-how of others in their work for us, we may be subject to claims that we or these individuals have used or disclosed intellectual property, including
trade secrets or other proprietary information, of any such individual’s current or former employer. Litigation may be necessary to defend against these
claims. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel.
Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management.
In addition, while it is our policy to require our employees and contractors who may be involved in the conception or development of intellectual property
to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who, in fact,
conceives or develops intellectual property that we regard as our own. The assignment of intellectual property rights may not be self-executing, or the
assignment agreements may be breached, and we may be forced to bring claims against third parties, or defend claims that they may bring against us, to
determine the ownership of what we regard as our intellectual property. Such claims could have a material adverse effect on our business, financial
condition, results of operations, and prospects.
Third-party claims of intellectual property infringement, misappropriation or other violation against us or our collaborators may prevent or delay the
development and commercialization of our product candidates, proprietary product platform and other technologies.
The field of developing therapeutics that target the microbiome is competitive and dynamic. Due to the focused research and development that is taking
place by several companies, including us and our competitors, in this field, the intellectual property landscape is in flux, and it may remain uncertain in the
future. As such, there may be significant intellectual property related litigation and proceedings relating to our owned, and other third party, intellectual
property and proprietary rights in the future.
Our commercial success depends in part on our and our collaborators’ ability to avoid infringing, misappropriating and otherwise violating the patents and
other intellectual property rights of third parties. There is a substantial amount of complex litigation involving patents and other intellectual property rights
in the biotechnology and pharmaceutical industries, as well as administrative proceedings for challenging patents, including interference, derivation and
reexamination proceedings before the USPTO or oppositions and other comparable proceedings in foreign jurisdictions. As discussed above, due to
changes in U.S. law referred to as patent reform, additional procedures including inter partes review and post-grant review have been implemented. As
stated above, this reform adds uncertainty to the possibility of challenge to our patents in the future.
Numerous U.S. and foreign issued patents and pending patent applications owned by third parties exist relating to glycan technologies and in the fields in
which we are developing our product candidates. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk
increases that our product candidates, proprietary product platform technologies and other technologies may give rise to claims of infringement of the
patent rights of others. We cannot be assured that our product candidates, proprietary product platform technologies and other technologies that we have
developed, are developing or may develop in the future will not infringe existing or future patents owned by third parties. We may not be aware of patents
that have already been issued and that a third party, for example, a competitor in the fields in which we are developing our product candidates, proprietary
product platform and other technologies might assert are infringed by our current or future product candidates, proprietary product platform or other
technologies, including claims to compositions, formulations,
74
methods of manufacture or methods of use or treatment that cover our product candidates, proprietary product platform or other technologies. It is also
possible that patents owned by third parties of which we are aware, but which we do not believe are relevant to our product candidates, proprietary product
platform or other technologies, could be found to be infringed by our product candidates, proprietary product platform or other technologies. In addition,
because patent applications can take many years to issue, there may be currently pending patent applications that may later result in issued patents that our
product candidates, proprietary product platform or other technologies may infringe. We cannot provide any assurances that third-party patents do not exist
which might be enforced against our current technology, including our proprietary product platform technologies, manufacturing methods, product
candidates, or future methods or products resulting in either an injunction prohibiting our manufacture or future sales, or, with respect to our future sales, an
obligation on our part to pay royalties and/or other forms of compensation to third parties, which could be significant.
Third parties may have patents or obtain patents in the future and claim that the manufacture, use or sale of our product candidates, proprietary product
platform or other technologies infringes upon these patents. In the event that any third-party claims that we infringe their patents or that we are otherwise
employing their proprietary technology without authorization and initiates litigation against us, even if we believe such claims are without merit, a court of
competent jurisdiction could hold that such patents are valid, enforceable and infringed by our product candidates, proprietary product platform or other
technologies. In this case, the holders of such patents may be able to block our ability to commercialize the applicable product candidate or technology
unless we obtain a license under the applicable patents, or until such patents expire or are finally determined to be held invalid or unenforceable. Such a
license may not be available on commercially reasonable terms or at all. Even if we are able to obtain a license, the license would likely obligate us to pay
license fees or royalties or both, and the rights granted to us might be non-exclusive, which could result in our competitors gaining access to the same
intellectual property. If we are unable to obtain a necessary license to a third-party patent on commercially reasonable terms, we may be unable to
commercialize our product candidates, proprietary product platform, or other technologies, or such commercialization efforts may be significantly delayed,
which could in turn significantly harm our business.
Defense of infringement claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of management
and other employee resources from our business, and may impact our reputation. In the event of a successful claim of infringement against us, we may be
enjoined from further developing or commercializing our infringing product candidates, proprietary product platform, or other technologies. In addition, we
may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties,
pay royalties and/or redesign our infringing product candidates or technologies, which may be impossible or require substantial time and monetary
expenditure. In that event, we would be unable to further develop and commercialize our product candidates, proprietary product platform, or other
technologies, which could harm our business significantly.
Engaging in litigation to defend against third parties alleging that we have infringed, misappropriated or otherwise violated their patents or other
intellectual property rights is very expensive, particularly for a company of our size, and time-consuming. Some of our competitors may be able to sustain
the costs of litigation or administrative proceedings more effectively than we can because of greater financial resources. Patent litigation and other
proceedings may also absorb significant management time. Uncertainties resulting from the initiation and continuation of patent litigation or other
proceedings against us could impair our ability to compete in the marketplace. The occurrence of any of the foregoing could have a material adverse effect
on our business, financial condition or results of operations.
We may become involved in lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive, time-consuming,
and unsuccessful.
Competitors may infringe our patents, or we may be required to defend against claims of infringement. In addition, our patents also may become involved
in inventorship, priority or validity disputes. To counter or defend against such claims can be expensive and time-consuming. In an infringement
proceeding, a court may decide that a patent owned by us is invalid or unenforceable, the other party’s use of our patented technology falls under the safe
harbor to patent infringement under 35 U.S.C. §271(e), or may refuse to stop the other party from using the technology at issue on the grounds that our
owned patents do not cover the technology in question. An adverse result in any litigation proceeding could put one or more of our owned patents at risk of
being invalidated or interpreted narrowly.
75
Even if we establish infringement, the court may decide not to grant an injunction against further infringing activity and instead award only monetary
damages, which may or may not be an adequate remedy. Furthermore, because of the substantial amount of discovery required in connection with
intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation.
Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and
could distract our personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions, or
other interim proceedings or developments, and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse
effect on the price of our common stock. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available
for development activities or any future sales, marketing, or distribution activities. We may not have sufficient financial or other resources to conduct such
litigation or proceedings adequately. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we
can because of their greater financial resources and more mature and developed intellectual property portfolios. Uncertainties resulting from the initiation
and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace.
If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our
business may be adversely affected.
Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on
other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential
partners or customers in our markets of interest. At times, competitors or other third parties may adopt trade names or trademarks similar to ours, thereby
impeding our ability to build brand identity and possibly leading to market confusion. If we assert trademark infringement claims, a court may determine
that the marks we have asserted are invalid or unenforceable, or that the party against whom we have asserted trademark infringement has superior rights to
the marks in question. In this case, we could ultimately be forced to cease use of such trademarks. In addition, there could be potential trade name or
trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations of our registered or unregistered
trademarks or trade names. Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not
be able to compete effectively, and our business may be adversely affected. Our efforts to enforce or protect our proprietary rights related to trademarks,
trade secrets, domain names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and
could adversely affect our business, financial condition, results of operations and prospects.
Intellectual property rights do not necessarily address all potential threats.
The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not
adequately protect our business or permit us to maintain our competitive advantage. For example:
•
others may be able to make products that are similar to our product candidates or utilize similar technology but that are not covered by the
claims of the patents that we may own;
•
we, or our current or future licensors or collaborators, might not have been the first to make the inventions covered by the issued patent or
pending patent application that we own now or in the future;
•
we, or our current or future licensors or collaborators, might not have been the first to file patent applications covering certain of our or their
inventions;
•
others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our owned
intellectual property rights;
•
it is possible that our current or future pending owned patent applications will not lead to issued patents;
•
issued patents that we hold rights to may be held invalid or unenforceable, including as a result of legal challenges by our competitors or
other third parties;
76
•
our competitors or other third parties might conduct research and development activities in countries where we do not have patent rights and
then use the information learned from such activities to develop competitive products for sale in our major commercial markets;
•
we may not develop additional proprietary technologies that are patentable;
•
the patents of others may harm our business; and
•
we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent
covering such intellectual property.
Should any of these events occur, they could have a material adverse effect on our business, financial condition, results of operations and prospects.
Risks related to our reliance on third parties
We will rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected
deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize any potential product
candidates.
We will depend upon third parties, including independent investigators, to conduct our clinical trials under agreements with universities, medicinal
institutions, CROs, strategic partners and others. We expect to have to negotiate budgets and contracts with CROs and trial sites, which may result in delays
to our development timelines and increased costs.
We will rely heavily on third parties over the course of our clinical trials, and, as a result, will have limited control over the clinical investigators and
limited visibility into their day-to-day activities, including with respect to their compliance with the approved clinical protocol. Nevertheless, we are
responsible for ensuring that each of our clinical trials is conducted in accordance with the applicable protocol, legal and regulatory requirements and
scientific standards, and our reliance on third parties does not relieve us of our regulatory responsibilities. We and these third parties are required to comply
with GCP requirements, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for product candidates in
clinical development. Regulatory authorities enforce these GCP requirements through periodic inspections of trial sponsors, clinical investigators and trial
sites. If we or any of these third parties fail to comply with applicable GCP requirements, the clinical data generated in our clinical trials may be deemed
unreliable and the FDA or comparable foreign regulatory authorities may require us to suspend or terminate these trials or perform additional preclinical
studies or clinical trials before approving our marketing applications. We cannot be certain that, upon inspection, such regulatory authorities will determine
that any of our clinical trials comply with the GCP requirements. In addition, our clinical trials for therapeutic indications must be conducted with drug
product produced under cGMP requirements and may require a large number of patients.
Our failure or any failure by these third parties to comply with these regulations or to recruit a sufficient number of patients may require us to repeat
clinical trials, which would delay the regulatory approval or commercialization process. Moreover, our business may be implicated if any of these third
parties violates federal or state fraud and abuse or false claims laws and regulations or healthcare privacy and security laws.
Any third parties conducting our future clinical trials will not be our employees and, except for remedies that may be available to us under our agreements
with such third parties, we cannot control whether or not they devote sufficient time and resources to our ongoing preclinical and clinical programs. These
third parties may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials or
other product development activities, which could affect their performance on our behalf. If these third parties do not successfully carry out their
contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is
compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our clinical trials may be extended,
delayed or terminated and we may not be able to complete development of, obtain regulatory approval of or successfully commercialize our product
candidates. As a result, our financial results and the commercial prospects for our product candidates would be harmed, our costs could increase and our
ability to generate revenue could be delayed.
77
If any of our relationships with these third-party CROs or others terminate, we may not be able to enter into arrangements with alternative CROs or other
third parties or to do so on commercially reasonable terms. Switching or adding additional CROs involves additional cost and requires management time
and focus. In addition, there is a natural transition period when a new CRO begins work. As a result, delays may occur, which can materially impact our
ability to meet our desired clinical development timelines. Though we carefully manage our relationships with our CROs, there can be no assurance that we
will not encounter similar challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business,
financial condition and prospects.
We expect to rely on third parties to manufacture our clinical supply of product candidates, and we intend to rely on third parties to produce and
process our products, if approved.
We currently rely on outside vendors to supply raw materials and other important components, such as the heterogeneous catalyst and chromatographic
resins used to purify crude MMT candidates. We have not yet caused any product candidates to be manufactured or processed on a commercial scale and
may not be able to do so for any of our product candidates. We will make changes as we work to optimize the manufacturing process for our product
candidates, and we cannot be sure that even minor changes in the process will result in therapies that are safe and effective.
The facilities used to manufacture our product candidates that we develop as therapeutic product candidates must be approved by the FDA or other foreign
regulatory agencies pursuant to inspections that will be conducted after we submit a marketing application to the FDA or other foreign regulatory agencies.
Since March 2020 when foreign and domestic inspections of facilities were largely placed on hold, the FDA has been working to resume routine
surveillance, bioresearch monitoring and pre-approval inspections on a prioritized basis. Since April 2021, the FDA has conducted limited inspections and
employed remote interactive evaluations, using risk management methods, to meet user fee commitments and goal dates. Ongoing travel restrictions and
other uncertainties continue to impact oversight operations both domestic and abroad and it is unclear when standard operational levels will resume. The
FDA is continuing to complete mission-critical work, prioritize other higher-tiered inspectional needs (e.g., for-cause inspections), and carry out
surveillance inspections using risk-based approaches for evaluating public health. Should FDA determine that an inspection is necessary for approval and
an inspection cannot be completed during the review cycle due to restrictions on travel, and the FDA does not determine a remote interactive evaluation to
be adequate, the agency has stated that it generally intends to issue, depending on the circumstances, a complete response letter or defer action on the
application until an inspection can be completed. During the COVID-19 public health emergency, a number of companies announced receipt of complete
response letters due to the FDA’s inability to complete required inspections for their applications. Regulatory authorities outside the U.S. may adopt similar
restrictions or other policy measures in response to the ongoing COVID-19 pandemic and may experience delays in their regulatory activities.
Additionally, any facilities used for the manufacture of product candidates commercialized for non-therapeutic uses will be subject to registration with and
inspection by the FDA and foreign regulatory authorities. We do not currently control all aspects of the manufacturing process of, and are currently largely
dependent on, our contract manufacturing partners for compliance with regulatory requirements, known as cGMP requirements, for manufacture of our
product candidates. If and when our manufacturing facility becomes operational, we will be responsible for compliance with cGMP requirements. If we or
our contract manufacturers cannot successfully manufacture in conformance with our specifications and the strict regulatory requirements of the FDA or
other regulatory authorities, we and they will not be able to secure and/or maintain regulatory approval for their manufacturing facilities with respect to the
manufacture of our product candidates. In addition, we have limited control over the ability of our contract manufacturers to maintain adequate quality
control, quality assurance and qualified personnel. If the FDA or a comparable foreign regulatory authority does not approve these facilities for the
manufacture of our product candidates or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which
would significantly impact our ability to develop, obtain regulatory approval for or market our product candidates, if approved.
For more information, see “Risk Factors—Risks Related to Manufacturing and Supply” below.
78
If our sole contract manufacturing organization for materials to be used in our clinical trials fails to supply us with the necessary materials, we may be
unable to complete our clinical trials on a timely basis, if at all.
In 2018, we entered into a services agreement with a subsidiary of Thermo Fisher Scientific, or Thermo Fisher, to handle the manufacturing supply chain
from drug substance synthesis through labeling and packaging for our planned clinical trials. If Thermo Fisher is unable or unwilling to provide us with
sufficient quantities of applicable MMT candidates to meet our demands or fails to meet our standards of quality or other specification or to achieve drug
cGMP compliance, we may not be able to locate any alternative suppliers or enter into commercially reasonable agreements with substitute suppliers in a
timely manner or at all.
Third-party relationships are important to our business. If we are unable to maintain our collaborations, enter into new relationships or if these
relationships are not successful, our business could be adversely affected.
We have limited capabilities for product development and do not yet have any capability for sales, marketing or distribution. Accordingly, we enter into
relationships with other companies to provide us with important technologies, and we may receive additional technologies and funding under these and
other collaborations in the future. Relationships we enter into, may pose a number of risks, including the following:
•
third parties have, and future third-party collaborators may have, significant discretion in determining the efforts and resources that they will
apply;
•
current and future third parties may not perform their obligations as expected, including as a result of impacts due to the COVID-19
pandemic;
•
current and future third parties may not pursue development and commercialization of any product candidates that achieve regulatory
approval or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the
third parties’ strategic focus or available funding, or external factors, such as a strategic transaction that may divert resources or create
competing priorities;
•
third parties may delay clinical studies or clinical trials, provide insufficient funding for a clinical study or clinical trial program, stop a
clinical study or clinical trial or abandon a product candidate, repeat or conduct clinical studies or new clinical trials or require a new
formulation of a product candidate for clinical testing;
•
current and future third parties could independently develop, or develop with third parties, products that compete directly or indirectly with
our products and product candidates if the third parties believe that the competitive products are more likely to be successfully developed or
can be commercialized under terms that are more economically attractive than ours;
•
product candidates discovered in collaboration with us may be viewed by our current or future third parties as competitive with their own
product candidates or products, which may cause such third parties to cease to devote resources to the commercialization of our product
candidates;
•
current and future third parties may fail to comply with applicable regulatory requirements regarding the development, manufacture,
distribution or marketing of a product candidate or product;
•
current and future third parties with marketing and distribution rights to one or more of our product candidates that achieve regulatory
approval may not commit sufficient resources to the marketing and distribution of such product or products;
•
disagreements with current or future third parties, including disagreements over proprietary rights, contract interpretation or the preferred
course of development, might cause delays or terminations of the research, development or commercialization of product candidates, might
lead to additional responsibilities for us with respect to product candidates, or might result in litigation or arbitration, any of which would be
time-consuming and expensive;
•
current and future third parties may not properly maintain or defend our intellectual property rights or may use our proprietary information in
such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to
potential litigation;
79
•
current and future third parties may infringe the intellectual property rights of third parties, which may expose us to litigation and potential
liability;
•
if a current or future third parties of ours is involved in a business combination, the collaborator might deemphasize or terminate the
development or commercialization of any product candidate licensed to it by us; and
•
current and future relationships may be terminated by the collaborator, and, if terminated, we could be required to raise additional capital to
pursue further development or commercialization of the applicable product candidates.
If our relationships do not result in the successful discovery, development and commercialization of products or if one of our third parties terminates its
agreement with us, we may not receive any future research funding or milestone or royalty payments under the collaboration. If we do not receive the
funding we expect under these agreements, our development of our technology and product candidates could be delayed and we may need additional
resources to develop product candidates and our technology. All of the risks relating to product development, regulatory approval and commercialization
described in this Annual Report on Form 10-K also apply to the activities of our therapeutic collaborators.
Additionally, if any of our current or future third parties terminate its agreement with us, we may find it more difficult to attract new collaborators and our
perception in the business and financial communities could be adversely affected.
Relationships are complex and time-consuming to negotiate and document. In addition, there have been a significant number of recent business
combinations among large pharmaceutical companies that have resulted in a reduced number of potential future collaborators. We face significant
competition in seeking appropriate collaborators. Our ability to reach a definitive agreement for a collaboration will depend, among other things, upon our
assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation
of a number of factors. If we are unable to reach agreements with suitable third parties on a timely basis, on acceptable terms, or at all, we may have to
curtail the development of a product candidate, reduce or delay its development program or one or more of our other development programs, delay its
potential commercialization or reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development or
commercialization activities at our own expense. If we elect to increase our expenditures to fund development or commercialization activities on our own,
we may need to obtain additional expertise and additional capital, which may not be available to us on acceptable terms, or at all. If we fail to enter into
relationships or do not have sufficient funds or expertise to undertake the necessary development and commercialization activities, we may not be able to
further develop our product candidates, bring them to market and generate revenue from sales of drugs or continue to develop our technology, and our
business may be materially and adversely affected.
Risks related to manufacturing and supply
Our MMT product candidates rely on the availability of specialty raw materials, which may not be available to us on acceptable terms or at all.
Our product candidates require certain specialty raw materials, some of which we obtain from small companies with limited resources and experience to
support a commercial product. The suppliers may be ill-equipped to support our needs, especially in non-routine circumstances like an FDA inspection or
medical crisis, such as widespread contamination. We do not currently have contracts in place with all of the suppliers that we may need at any point in
time, and if needed, may not be able to contract with them on acceptable terms or at all. Accordingly, we may experience delays in receiving key raw
materials to support clinical or commercial manufacturing.
80
Our product candidates require specialized manufacturing capabilities. If we or any of our third-party manufacturers encounter difficulties in
manufacturing our product candidates, our ability to provide supply of our product candidates for clinical trials or our products for patients, if
approved, could be delayed or stopped, or we may be unable to maintain a commercially viable cost structure.
The manufacturing process used to produce our product candidates has not yet been validated for commercial production. Our cGMP manufacturing
process development and scale-up is at an early stage. The actual cost to manufacture and process our product candidates could be greater than we expect
and could materially and adversely affect the commercial viability of our product candidates.
Our manufacturing process may be susceptible to manufacturing issues associated with interruptions in the manufacturing process, contamination,
equipment or reagent failure, improper installation or operation of equipment, vendor or operator error, and variability in product characteristics. Even
minor deviations from normal manufacturing processes could result in reduced production yields, lot failures, product defects, product recalls, product
liability claims and other supply disruptions. If microbial, viral or other contaminations are discovered in our product candidates or in the manufacturing
facilities in which our product candidates are made, production at such manufacturing facilities may be interrupted for an extended period of time to
investigate and remedy the contamination. Further, as product candidates are developed through preclinical to late-stage clinical trials toward approval and
commercialization, it is common that various aspects of the development program, such as manufacturing methods, are altered along the way in an effort to
optimize processes and results. Such changes carry the risk that they will not achieve these intended objectives, and any of these changes could cause our
product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials.
Although we continue to refine our manufacturing process for our MMT product candidates, doing so is a difficult and uncertain task, and there are risks
associated with scaling to the level required for advanced clinical trials or commercialization, including, among others, cost overruns, potential problems
with process scale-up, process reproducibility, stability issues, lot consistency, and timely availability of reagents and/or raw materials. We ultimately may
not be successful in transferring our production system from our contract manufacturer to any manufacturing facilities we establish ourselves, or our
contract manufacturer may not have the necessary capabilities to complete the implementation and development process. If we are unable to adequately
validate or scale-up the manufacturing process for our product candidates with our current manufacturer, we will need to transfer to another manufacturer
and complete the manufacturing validation process, which can be lengthy. If we are able to adequately validate and scale-up the manufacturing process for
our product candidates with a contract manufacturer, we will still need to negotiate with such contract manufacturer an agreement for commercial supply,
and it is not certain we will be able to come to agreement on terms acceptable to us. As a result, we may ultimately be unable to reduce the cost of goods
for our product candidates to levels that will allow for an attractive return on investment if and when those product candidates are commercialized.
The manufacturing process for any products that we may develop for therapeutic indications is subject to the FDA and foreign regulatory authority
approval process, and we will need to contract with manufacturers who can meet all applicable FDA and foreign regulatory authority requirements on an
ongoing basis. If we or our CMOs are unable to reliably produce products to specifications acceptable to the FDA or other regulatory authorities, we may
not obtain or maintain the approvals we need, where applicable, or be able to commercialize such products. Even if we obtain regulatory approval for any
of our product candidates for therapeutic indications, there is no assurance that either we or our CMOs will be able to manufacture the approved product to
specifications acceptable to the FDA or other regulatory authorities, to produce it in sufficient quantities to meet the requirements for the potential launch
of the product, or to meet potential future demand. Any of these challenges could delay completion of clinical trials, require bridging clinical trials or the
repetition of one or more clinical trials, increase clinical trial costs, delay approval of our product candidates, impair commercialization efforts, increase our
cost of goods, and have an adverse effect on our business, financial condition, results of operations and growth prospects. Our future success depends on
our ability to manufacture our products on a timely basis with acceptable manufacturing costs, while at the same time maintaining good quality control and
complying with applicable regulatory requirements, and an inability to do so could have a material adverse effect on our business, financial condition, and
results of operations. In addition, we could incur higher manufacturing costs if manufacturing processes or standards change, and we could need to replace,
modify, design, or build and install equipment, all of which would require additional capital expenditures. Specifically, because our product candidates may
have a higher cost of goods than conventional therapies, the risk that coverage and reimbursement rates may be inadequate for us to achieve profitability
may be greater.
81
We may depend on third parties for clinical and commercial supplies, including, in some instances, a single supplier.
We may depend on third-party suppliers for clinical and commercial supplies, including the active ingredients which are used in our product candidates.
These supplies may not always be available to us at the standards we require or on terms acceptable to us, or at all, and we may not be able to locate
alternative suppliers in a timely manner, or at all. If we are unable to obtain necessary clinical or commercial supplies, our manufacturing operations and
clinical trials and the clinical trials of our collaborators may be delayed or disrupted, and our business and prospects may be materially and adversely
affected as a result.
We may rely on a sole supplier for certain of our supplies. If this sole supplier is unable to supply to us in the quantities we require, or at all, or otherwise
defaults on its supply obligations to us, we may not be able to obtain alternative supplies from other suppliers on acceptable terms, in a timely manner, or at
all.
We have limited experience manufacturing our drug product candidates for purposes of clinical trials for therapeutic indications or for non-
therapeutic clinical studies or trials or the marketing of our products as non-drug products and at commercial scale, and if we decide to establish our
own manufacturing facility for our drug product candidates, we cannot assure you that we can manufacture our drug product candidates in
compliance with regulations at a cost or in quantities necessary to make them commercially viable.
We may establish a manufacturing facility for our product candidates for production as investigational new drugs for purposes of clinical trials for
therapeutic indications or for the production of non-drug product candidates at a commercial scale. We have limited experience in cGMP compliant
manufacturing of our drug product candidates for purposes of clinical trials in therapeutic indications or at a commercial scale. We similarly have limited
experience in complying with the manufacturing requirements for non-drug applications for our products at a commercial scale. In the future, we may
develop our manufacturing capacity in part by expanding our current facility or building additional facilities. This activity will require substantial
additional funds and we would need to hire and train a significant number of qualified employees to staff these facilities. We may not be able to develop
cGMP-compliant manufacturing facilities that are adequate to produce materials for additional later-stage clinical trials or commercial use.
The equipment and facilities employed in the manufacture of pharmaceuticals and foods (including medical foods) are subject to stringent qualification
requirements by regulatory agencies, including validation of facility, equipment, systems, processes and analytics. We may be subject to lengthy delays and
expense in conducting validation studies, if we can meet the requirements at all.
MMTs are complex and difficult to manufacture. We could experience production problems that may impact our ability to manufacture certain MMT
product candidates, if at all, and result in delays in our development or otherwise adversely affect our business.
The manufacturing process we anticipate using to produce our MMT product candidates is highly complex and may be subject to variation or production
difficulties. Issues with any of our manufacturing processes could result in insufficient yield, product deficiencies or manufacturing failures that result in
adverse patient reactions, lot failures and insufficient inventory.
Many factors could also cause production interruptions, including raw materials shortages, raw material failures, growth media failures, equipment
malfunctions, facility contamination, labor problems, natural disasters, disruption in utility services, terrorist activities or acts of god beyond our control.
We also may encounter problems in hiring and retaining the experienced specialized personnel needed to operate our manufacturing process, which could
result in delays in our production or difficulties in maintaining compliance with applicable regulatory requirements.
Any problems in our manufacturing processes could make us a less attractive collaborator for academic research institutions and other parties, which could
limit our access to additional attractive development programs, result in delays in our clinical development and materially harm our business.
82
Risks related to our common stock
There can be no assurance that we will be able to comply with the continued listing standards of Nasdaq.
If Nasdaq delists our shares of common stock from trading on its exchange for failure to meet Nasdaq’s listing standards, we and our stockholders could
face significant material adverse consequences including:
•
a limited availability of market quotations for our securities;
•
reduced liquidity for our securities;
•
a determination that our common stock is a “penny stock” which will require brokers trading in our common stock to adhere to more
stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities;
•
a limited amount of news and analyst coverage; and
•
a decreased ability to issue additional securities or obtain additional financing in the future.
An active trading market for our common stock may not be sustained
Our shares of common stock began trading on The NASDAQ Global Select Market on February 28, 2019. Given the limited trading history of our common
stock, there is a risk that an active trading market for our shares will not be sustained, which could put downward pressure on the market price of our
common stock and thereby affect the ability of our stockholders to sell their shares.
The price of our stock may be volatile, and you could lose all or part of your investment.
The trading price of our common stock is likely to be highly volatile and could be subject to wide fluctuations in response to various factors, some of which
are beyond our control, including limited trading volume. Since our common stock began trading on The Nasdaq Global Select Market on February 28,
2019, our stock price has traded at prices as low as $1.30 per share and as high as $20.50 per share through March 25, 2022. In addition to the factors
discussed in this “Risk Factors” section and elsewhere in this Annual Report on Form 10-K, these factors include:
•
the commencement, enrollment or results of our ongoing and planned clinical studies and clinical trials of our product candidates or any
future clinical studies or clinical trials we may conduct, or changes in the development status of our product candidates;
•
any delay in our regulatory filings for our product candidates and any adverse development or perceived adverse development with respect to
the applicable regulatory authority’s review of such filings;
•
adverse results from or delays in clinical studies or clinical trials of our product candidates, including as a result of clinical holds, safety
events, enrollment difficulties, or study protocol amendments;
•
our decision to initiate a clinical study or clinical trial, not to initiate a clinical study or clinical trial or to terminate an existing clinical study
or clinical trial;
•
adverse regulatory decisions, including failure to receive regulatory approval of our product candidates for therapeutic indications or to
proceed on alternate regulatory pathways to market for our product candidates;
•
changes in laws or regulations applicable to our products, including but not limited to clinical trial requirements for approvals or marketing of
dietary non-drug products or food products;
•
adverse developments concerning our manufacturers;
•
our inability to obtain adequate product supply for any approved product or inability to do so at acceptable prices;
•
our inability to establish collaborations, if needed;
83
•
our failure to commercialize our product candidates;
•
additions or departures of key scientific or management personnel;
•
unanticipated serious safety concerns related to the use of our product candidates;
•
positive data readouts or introduction of new products or services by our competitors;
•
announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;
•
our ability to effectively manage our growth;
•
the size and growth of our initial target markets;
•
actual or anticipated variations in quarterly operating results;
•
our cash position;
•
our failure to meet the estimates and projections of the investment community or that we may otherwise provide to the public;
•
publication of research reports about us or our industry, or microbiome therapies in particular, or positive or negative recommendations or
withdrawal of research coverage by securities analysts;
•
changes in the market valuations of similar companies;
•
overall performance of the equity markets;
•
sales of our common stock by us or our stockholders in the future;
•
trading volume of our common stock;
•
adoption of new accounting standards;
•
ineffectiveness of our internal controls;
•
disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection
for our technologies;
•
significant lawsuits, including patent or stockholder litigation;
•
general political and economic conditions; and
•
other events or factors, many of which are beyond our control.
In addition, the stock market in general, and the market for healthcare companies in particular, have experienced extreme price and volume fluctuations that
have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may negatively affect
the market price of our common stock, regardless of our actual operating performance. You may not realize any return on your investment in us and may
lose some or all of your investment. In the past, securities class action litigation has often been instituted against companies following periods of volatility
in the market price of a company’s securities. This type of litigation, if instituted, could result in substantial costs and a diversion of management’s attention
and resources, which would harm our business, operating results or financial condition.
We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.
We currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not anticipate declaring or
paying any cash dividends for the foreseeable future. In addition, our ability to pay cash dividends is currently restricted by the terms of our credit facility
with Hercules Capital, Inc., and future debt or other financing arrangements may contain terms prohibiting or limiting the amount of dividends that may be
declared or paid on our common stock. Any return to stockholders will therefore be limited in the foreseeable future to the appreciation of their stock.
84
Our principal stockholders and management own a significant percentage of our stock and may be able to exert significant control over matters subject
to stockholder approval.
Our executive officers, directors and their affiliates beneficially hold, in the aggregate, over 50% of our outstanding voting stock. These stockholders will
have the ability to influence us through this ownership position. These stockholders may be able to determine all matters requiring stockholder approval.
For example, these stockholders may be able to control elections of directors, amendments of our organizational documents, or approval of any merger, sale
of assets, or other major corporate transaction. This may prevent or discourage unsolicited acquisition proposals or offers for our common stock that you
may feel are in your best interest as one of our stockholders.
We are an emerging growth company and a smaller reporting company, and we cannot be certain if the reduced reporting requirements applicable to
emerging growth companies and smaller reporting companies will make our common stock less attractive to investors.
We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act, or the JOBS Act, enacted in April 2012 as well as a smaller
reporting company, as defined by the Securities and Exchange Commission (SEC). For as long as we continue to be an emerging growth company or a
smaller reporting company, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies that
are not emerging growth companies or smaller reporting companies. With respect to being an emerging growth company, these exemptions include, not
being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended, or the Sarbanes-Oxley
Act, reduced disclosure obligations regarding executive compensation in this Annual Report on Form 10-K and our periodic reports and proxy statements
and exemptions from the requirements of holding nonbinding advisory votes on executive compensation and stockholder approval of any golden parachute
payments not previously approved. We could be an emerging growth company for up to five years following 2019, the year in which we completed our
IPO, although circumstances could cause us to lose that status earlier. We will remain an emerging growth company until the earlier of (1) the last day of
the fiscal year (a) following the fifth anniversary of the completion of our IPO; (b) in which we have total annual gross revenue of at least $1.07 billion; or
(c) in which we are deemed to be a large accelerated filer, which requires the market value of our common stock that is held by non-affiliates to exceed
$700 million as of the prior June 30th; and (2) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year
period. We cannot predict if investors will find our common stock less attractive because we may rely on these exemptions. If some investors find our
common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.
Under the JOBS Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as those standards apply to
private companies. We have elected to avail ourselves of such extended transition period, which means that when a standard is issued or revised and it has
different application dates for public or private companies, we may adopt the new or revised standard at the time private companies adopt the new or
revised standard and may do so until such time that we either (i) irrevocably elect to “opt out” of such extended transition period or (ii) no longer qualify as
an emerging growth company. This may make comparison of our financial statements with the financial statements of another public company that is not
an emerging growth company, or an emerging growth company that has opted out of using the extended transition period, difficult or impossible because of
the potential differences in accounting standards used.
We will incur significant increased costs as a result of operating as a public company, and our management will be required to devote substantial time
to new compliance initiatives.
As a public company, we will continue to incur significant legal, accounting and other expenses that we did not incur as a private company. We are subject
to the reporting requirements of the Securities Exchange Act of 1934, as amended, which require, among other things, that we file with the SEC, annual,
quarterly and current reports with respect to our business and financial condition. In addition, the Sarbanes-Oxley Act, as well as rules subsequently
adopted by the SEC and The NASDAQ Global Select Market to implement provisions of the Sarbanes-Oxley Act, impose significant requirements on
public companies, including requiring establishment and maintenance of effective disclosure and financial controls and changes in corporate governance
practices. Further, in July 2010, the Dodd-Frank Wall Street Reform and Consumer Protection Act, or the Dodd-Frank Act, was enacted. There are
significant corporate governance and executive compensation related provisions in the Dodd-Frank Act that require
85
the SEC to adopt additional rules and regulations in these areas, such as “say on pay” and proxy access. Recent legislation permits emerging growth
companies to implement many of these requirements over a longer period and up to five years from the pricing of our IPO. We intend to take advantage of
this new legislation but cannot guarantee that we will not be required to implement these requirements sooner than budgeted or planned and thereby incur
unexpected expenses. Stockholder activism, the current political environment and the current high level of government intervention and regulatory reform
may lead to substantial new regulations and disclosure obligations, which may lead to additional compliance costs and impact the manner in which we
operate our business in ways we cannot currently anticipate.
If these requirements divert the attention of our management and personnel from other business concerns, they could have a material adverse effect on our
business, financial condition and results of operations. The increased costs will decrease our net income or increase our net loss and may require us to
reduce costs in other areas of our business or increase the prices of our products or services. For example, we expect these rules and regulations to make it
more difficult and more expensive for us to obtain director and officer liability insurance and we may be required to incur substantial costs to maintain the
same or similar coverage. The impact of these requirements could also make it more difficult for us to attract and retain qualified persons to serve on our
board of directors, our board committees or as executive officers.
Sales of a substantial number of shares of our common stock by our existing stockholders in the public market could cause our stock price to fall.
If our existing stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market, the trading price of our
common stock could decline.
In addition, shares of common stock that are either subject to outstanding options or reserved for future issuance under our existing equity compensation
plans will become eligible for sale in the public market to the extent permitted by the provisions of various vesting schedules. If these additional shares of
common stock are sold, or if it is perceived that they will be sold, in the public market, the trading price of our common stock could decline. Additionally,
the number of shares of our common stock reserved for issuance under our 2019 Stock Option and Incentive Plan increased on January 1, 2020 and will
increase each January 1 thereafter by 4% of the number of shares of common stock outstanding on the immediately preceding December 31 or such lesser
number of shares determined by our compensation committee. Unless our board of directors elects not to increase the number of shares available for future
grant each year, our stockholders may experience additional dilution.
Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to
fall below expectations or our guidance.
Our quarterly and annual operating results may fluctuate significantly in the future, which makes it difficult for us to predict our future operating results.
From time to time, we may enter into license or collaboration agreements with other companies that include development funding and significant upfront
and milestone payments and/or royalties, which may become an important source of our revenue. Accordingly, our revenue may depend on development
funding and the achievement of development and clinical milestones under current and any potential future license and collaboration agreements and sales
of our products, if approved. These upfront and milestone payments may vary significantly from period to period and any such variance could cause a
significant fluctuation in our operating results from one period to the next.
In addition, we measure compensation cost for stock-based awards made to employees, directors and non-employee consultants based on the fair value of
the award on either the grant date or service completion date, and we recognize the cost as an expense over the recipient’s service period. Because the
variables that we use as a basis for valuing stock-based awards change over time, including our underlying stock price and stock price volatility, the
magnitude of the expense that we must recognize may vary significantly.
86
Furthermore, our operating results may fluctuate due to a variety of other factors, many of which are outside of our control and may be difficult to predict,
including the following:
•
the timing and cost of, and level of investment in, research and development activities relating to our current and any future product
candidates, which will change from time to time;
•
our ability to enroll patients in clinical studies or clinical trials and the timing of enrollment;
•
the cost of manufacturing our current and any future product candidates, which may vary depending on FDA guidelines and requirements,
the quantity of production and the terms of our agreements with manufacturers;
•
expenditures that we may incur to acquire or develop additional product candidates and technologies;
•
the timing and outcomes of clinical trials for our current product candidates and any other future product candidates or competing product
candidates;
•
competition from existing and potential future products that compete with our current product candidates and any other future product
candidates, and changes in the competitive landscape of our industry, including consolidation among our competitors or partners;
•
any delays in regulatory review or approval or commercialization of our current product candidates or any other future product candidates;
•
the level of demand for our current product candidates and any other future product candidates, if approved, which may fluctuate
significantly and be difficult to predict;
•
the risk/benefit profile, cost and reimbursement policies with respect to our products candidates, if approved, and existing and potential future
products that compete with our current product candidates and any other future product candidates;
•
our ability to commercialize our current product candidates and any other future product candidates inside and outside of the United States,
either independently or working with third parties;
•
our ability to adequately support future growth;
•
potential unforeseen business disruptions that increase our costs or expenses;
•
future accounting pronouncements or changes in our accounting policies; and
•
the changing and volatile global economic environment.
The cumulative effect of these factors could result in large fluctuations and unpredictability in our quarterly and annual operating results. As a result,
comparing our operating results on a period-to-period basis may not be meaningful. Investors should not rely on our past results as an indication of our
future performance. This variability and unpredictability could also result in our failing to meet the expectations of industry or financial analysts or
investors for any period. If our revenue or operating results fall below the expectations of analysts or investors or below any forecasts we may provide to
the market, or if the forecasts we provide to the market are below the expectations of analysts or investors, the price of our common stock could decline
substantially. Such a stock price decline could occur even when we have met any previously publicly stated revenue and/or earnings guidance we may
provide.
87
Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control which could limit the market price
of our common stock and may prevent or frustrate attempts by our stockholders to replace or remove our current management.
Our amended and restated certificate of incorporation and amended and restated by-laws contain provisions that could delay or prevent a change of control
of our company or changes in our board of directors that our stockholders might consider favorable. Some of these provisions include:
•
a board of directors divided into three classes serving staggered three-year terms, such that not all members of the board will be elected at
one time;
•
a prohibition on stockholder action through written consent, which requires that all stockholder actions be taken at a meeting of our
stockholders;
•
a requirement that special meetings of stockholders be called only by the chair of the board of directors, the chief executive officer, or by a
majority of the total number of directors;
•
advance notice requirements for stockholder proposals and nominations for election to our board of directors;
•
a requirement that no member of our board of directors may be removed from office by our stockholders except for cause and, in addition to
any other vote required by law, upon the approval of not less than two-thirds of all outstanding shares of our voting stock then entitled to vote
in the election of directors;
•
a requirement of approval of not less than two-thirds of all outstanding shares of our voting stock to amend any by-laws by stockholder
action or to amend specific provisions of our certificate of incorporation; and
•
the authority of the board of directors to issue preferred stock on terms determined by the board of directors without stockholder approval and
which preferred stock may include rights superior to the rights of the holders of common stock.
In addition, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which
may prohibit certain business combinations with stockholders owning 15% or more of our outstanding voting stock. These anti-takeover provisions and
other provisions in our amended and restated certificate of incorporation and amended and restated by-laws could make it more difficult for stockholders or
potential acquirers to obtain control of our board of directors or initiate actions that are opposed by the then-current board of directors and could also delay
or impede a merger, tender offer or proxy contest involving our company. These provisions could also discourage proxy contests and make it more difficult
for you and other stockholders to elect directors of your choosing or cause us to take other corporate actions you desire. Any delay or prevention of a
change of control transaction or changes in our board of directors could cause the market price of our common stock to decline.
If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading
volume could decline.
The trading market for our common stock will depend in part on the research and reports that securities or industry analysts publish about us or our
business. If one or more of the analysts who covers us downgrades our stock or publishes inaccurate or unfavorable research about our business, our stock
price may decline. If one or more of these analysts ceases coverage of our company or fails to publish reports on us regularly, demand for our stock could
decrease, which might cause our stock price and trading volume to decline.
88
If we fail to maintain proper and effective internal control over financial reporting, our ability to produce accurate and timely financial statements
could be impaired, investors may lose confidence in our financial reporting and the trading price of our common stock may decline.
Pursuant to Section 404 of Sarbanes-Oxley, our management will be required to report upon the effectiveness of our internal control over financial
reporting beginning with the annual report for our fiscal year ending December 31, 2020. When we lose our status as an “emerging growth company,” our
independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reporting unless another
exemption applies. The rules governing the standards that must be met for management to assess our internal control over financial reporting are complex
and require significant documentation, testing and possible remediation. To comply with the requirements of being a reporting company under the
Exchange Act, we may need to implement additional financial and management controls, reporting systems and procedures and may need to hire additional
accounting and finance staff.
We cannot assure you that there will not be material weaknesses or significant deficiencies in our internal control over financial reporting in the future. Any
failure to maintain internal control over financial reporting could severely inhibit our ability to accurately report our financial condition, results of
operations or cash flows. If we are unable to conclude that our internal control over financial reporting is effective, or if our independent registered public
accounting firm determines we have a material weakness or significant deficiency in our internal control over financial reporting, investors may lose
confidence in the accuracy and completeness of our financial reports, the market price of our common stock could decline, and we could be subject to
sanctions or investigations by Nasdaq, the SEC or other regulatory authorities. Failure to remedy any material weakness in our internal control over
financial reporting, or to implement or maintain other effective control systems required of public companies, could also restrict our future access to the
capital markets.
If we engage in future acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause us to incur debt
or assume contingent liabilities, and subject us to other risks.
We may evaluate various acquisition opportunities and strategic partnerships, including licensing or acquiring complementary products, intellectual
property rights, technologies or businesses. Any potential acquisition or strategic partnership may entail numerous risks, including:
•
increased operating expenses and cash requirements;
•
the assumption of additional indebtedness or contingent liabilities;
•
the issuance of our equity securities;
•
assimilation of operations, intellectual property and products of an acquired company, including difficulties associated with integrating new
personnel;
•
the diversion of our management’s attention from our existing product programs and initiatives in pursuing such a strategic merger or
acquisition;
•
retention of key employees, the loss of key personnel and uncertainties in our ability to maintain key business relationships;
•
risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products or
product candidates and marketing approvals; and
•
our inability to generate revenue from acquired technology and/or products sufficient to meet our objectives in undertaking the acquisition or
even to offset the associated acquisition and maintenance costs.
In addition, if we undertake acquisitions, we may issue dilutive securities, assume or incur debt obligations, incur large one-time expenses and acquire
intangible assets that could result in significant future amortization expense. Moreover, we may not be able to locate suitable acquisition opportunities, and
this inability could impair our ability to grow or obtain access to technology or products that may be important to the development of our business.
89
Covenants and events of default in our debt instruments could limit our ability to undertake certain types of transactions and adversely affect our
liquidity.
Our current debt financing agreements contain, and our future debt financing agreements may contain covenants and events of default that may limit our
financial flexibility and ability to undertake certain types of transactions. Typically, these covenants would restrict our business activities, including
restrictions on:
•
creating liens;
•
engaging in mergers, consolidations and sales of assets;
•
incurring additional indebtedness;
•
providing guarantees;
•
engaging in different businesses;
•
making investments;
•
making certain dividend, debt and other restricted payments;
•
engaging in certain transactions with affiliates; and
•
entering into certain contractual obligations.
Our ability to comply with these expected covenants may depend on factors outside our control. We cannot assure you that we will be able to satisfy these
covenants. If we fail to satisfy the covenants established in these facilities or an event of default occurs under the applicable debt agreement, the maturity of
the debt instruments could be accelerated, or we could be prohibited from future borrowing. If our obligations under the debt instruments are accelerated
and we do not have sufficient cash on hand to pay all amounts due, we could be required to sell assets, to refinance all or a portion of our indebtedness or to
obtain additional financing through equity or debt financings. Refinancing may not be possible and additional financing may not be available on
commercially acceptable terms, or at all. If we cannot obtain such financing, we would need to curtail our planned operations.
Our amended and restated by-laws designate specific courts as the exclusive forum for certain litigation that may be initiated by our stockholders,
which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us.
Pursuant to our amended and restated by-laws, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of
Delaware will be the sole and exclusive forum for state law claims for (1) any derivative action or proceeding brought on our behalf; (2) any action
asserting a claim of breach of a fiduciary duty or other wrongdoing by any of our directors, officers, employees or agents to us or our stockholders; (3) any
action asserting a claim against us arising pursuant to any provision of the General Corporation Law of the State of Delaware or our certificate of
incorporation or by-laws; (4) any action to interpret, apply, enforce or determine the validity of our certificate of incorporation or by-laws; or (5) any action
asserting a claim governed by the internal affairs doctrine. The forum selection clause in our amended and restated by-laws may limit our stockholders’
ability to obtain a favorable judicial forum for disputes with us. Alternatively, if a court were to find the choice of forum provision contained in our restated
certificate of incorporation and amended and restated bylaws to be inapplicable or unenforceable in an action, we may incur additional costs associated
with resolving such action in other jurisdictions.
90
Item 1B. Unresolved Staff Comments
None.
Item 2. Properties
Our corporate headquarters are located in Lexington, Massachusetts, where we currently lease 107,000 square feet of laboratory and office space. The lease
expires in 2029, subject to one option to extend the lease for 10 years. We believe our facilities are sufficient for our current needs.
Item 3. Legal Proceedings
We are not currently a party to any material legal proceedings.
Item 4. Mine Safety Disclosures
None.
91
PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Certain Information Regarding the Trading of Our Common Stock
Our common stock trades under the symbol “KLDO” on the NASDAQ Global Select Market and has been publicly traded since February 28, 2019. Prior
to this time, there was no public market for our common stock.
Holders of Our Common Stock
As of March 31, 2022, there were approximately 67 holders of record of shares of our common stock. This number does not include stockholders for whom
shares are held in “nominee” or “street” name.
Dividends
We have never declared or paid any cash dividends on our capital stock. We currently intend to retain all available funds and any future earnings for use in
the operation of our business and do not anticipate paying any dividends on our common stock in the foreseeable future. Any future determination to
declare dividends will be made at the discretion of our board of directors and will depend on our financial condition, operating results, capital requirements,
debt compliance, general business conditions and other factors that our board of directors may deem relevant.
Securities Authorized for Issuance Under Equity Compensation Plans
Information about our equity compensation plans is included in Item 12 of this Annual Report on Form 10-K.
Unregistered Sales of Equity Securities and Use of Proceeds
Recent Sales of Unregistered Equity Securities
None.
Use of Proceeds from Initial Public Offering
None.
Purchases of Equity Securities by the Issuer and Affiliated Purchasers
We did not purchase any of our registered equity securities during the period covered by this Annual Report on Form 10-K.
Item 6. Selected Financial Data
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information requested under this
item.
92
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our consolidated financial
statements and related notes appearing at the end of this Annual Report on Form 10-K. Some of the information contained in this discussion and analysis
or set forth elsewhere in this Annual Report on Form 10-K, including information with respect to our plans and strategy for our business, includes forward-
looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Risk Factors” section of this
Annual Report on Form 10-K, our actual results could differ materially from the results described in, or implied by, the forward-looking statements
contained in the following discussion and analysis.
Overview
We are a clinical-stage healthcare company with a differentiated, chemistry-driven approach focused on leveraging the microbiome to treat disease and
improve human health. We have built a human-centric proprietary product platform for discovery and development that we believe will enable the rapid
advancement of a broad portfolio of novel product candidates using either human clinical studies under regulations supporting research with food or
clinical trials as drug candidates. Our product candidates are Microbiome Metabolic Therapies (“MMT” or “MMTs”) which are designed to modulate the
metabolic output and profile of the microbiome by driving the function and composition of existing microbes. We have an industrialized approach to the
discovery and development of MMTs, and our initial MMTs are targeted glycans. Each targeted glycan is an ensemble of complex carbohydrates that is
intended to modulate microbial metabolism and community composition to drive a specific biological response. We believe our MMTs have the potential to
be novel treatments across a variety of diseases and conditions.
We have initiated a process to explore a range of strategic alternatives to maximize shareholder value and have engaged professional advisors, including an
investment bank to act as a strategic advisor for this process. Potential strategic alternatives that may be evaluated include a sale or merger of the Company
or securing additional financing or partnerships that would enable further development of our programs. There can be no assurance that this strategic
review process will result in our pursuing any transaction or that any transaction, if pursued, will be completed. We aim to run this strategic review process
into mid-April 2022. Additionally, there can be no assurances that any particular course of action, business arrangement or transaction, or series of
transactions, will be pursued, successfully consummated or lead to increased stockholder value. If the strategic process is unsuccessful, our Board may
decide to pursue a dissolution and liquidation. In the event of such liquidation or other wind-down event, holders of our securities will likely suffer a total
loss of their investment.
We have or have had active programs in discovery, including work in ulcerative colitis, psoriasis, atopic immune disease, COPD, pathogens, and immuno-
oncology aimed at expanding our MMT platform and clinical pipeline in 2022 and beyond.
Since our inception in 2015, we have devoted substantially all of our resources to building our proprietary product platform, developing our pipeline of
MMT candidates, building our intellectual property portfolio and process development and manufacturing function, business planning, raising capital and
providing general and administrative support for these operations. To date, we have primarily financed our operations through public offering of our equity
securities, private placement of our convertible preferred stock and borrowings of long-term debt.
We have incurred significant net losses since inception and expect to continue to incur net operating losses for the foreseeable future. If we are able to
continue as a going concern, we expect to continue to incur significant expenses and increasing operating losses for at least the next several years. We
expect that our expenses and capital requirements will increase substantially in connection with our ongoing activities, particularly if and as we:
•
conduct preclinical studies, clinical studies and clinical trials for our product candidates;
•
advance the development of our product candidate pipeline;
•
continue to discover and develop additional product candidates;
93
•
continue to build out our proprietary product platform and to increase its throughput for the discovery and nomination of product candidates;
•
develop, acquire or in-license other product candidates and technologies;
•
maintain, expand and protect our intellectual property portfolio;
•
hire additional clinical, scientific and commercial personnel;
•
expand manufacturing capabilities, including in-house and third-party commercial manufacturing, through the purchase, renovation,
customization and operation of a manufacturing facility and securing supply chain capacity sufficient to provide clinical study and clinical
trial materials and commercial quantities of any product candidates which we may commercialize;
•
seek regulatory approvals for any product candidates for therapeutic indications that successfully complete clinical trials;
•
establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain regulatory approval or
identify alternate commercial pathways for such products; and
•
add operational, financial and management information systems and personnel, including personnel to support our product development and
planned future commercialization efforts, as well as to support our transition to a public reporting company.
We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for or
identify alternate non-drug pathways for our product candidates. If we obtain regulatory approval for or otherwise commercialize any of our product
candidates, we expect to incur significant expenses related to developing our commercialization capability to support product sales, marketing and
distribution.
As of December 31, 2021, we had $38.5 million in cash and cash equivalents and an accumulated deficit of $364.5 million. Based on our current operating
plans, we have sufficient cash and cash equivalents to fund our operating expenses and capital expenditures into the beginning of the second quarter of
2022. We will require substantial additional capital to sustain our operations and pursue our growth strategy, including the development of our MMT
candidates. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through equity or debt
financings or other capital sources, which may include collaborations with other companies or other strategic transactions. We may be unable to raise
additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such
agreements as and when needed, we may have to significantly delay, reduce or eliminate the development and commercialization of one or more of our
product candidates or delay our pursuit of potential in-licenses or acquisitions. These factors raise substantial doubt about our ability to continue as a going
concern. For more information, refer to “—Liquidity and Capital Resources” below and Note 1 to our condensed consolidated financial statements included
elsewhere in this Annual Report.
Because of the numerous risks and uncertainties associated with product development, we are unable to predict the timing or amount of increased expenses
or when or if we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If we fail to
become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be
forced to reduce or terminate our operations.
Recent Developments
In January 2022, we enacted a restructuring plan to reduce our operations to preserve financial resources, resulting in a reduction of our workforce by up to
20 positions. As a result, we incurred costs of $0.30 million that consisted of severance benefits for the affected employees and other restructuring costs.
On March 25, 2022, we entered into an amendment to our Loan and Security Agreement with Hercules, pursuant to which we made an immediate payment
of $15 million of the Tranche 1 Advance without any prepayment penalty.
94
This amendment also extended the interest only period of the term loan through April 1, 2023 and removed the minimum cash covenant that was
previously in place.
Additionally, we have initiated a process to evaluate strategic alternatives in order to maximize shareholder value. There can be no assurance that this
strategic review process will result in us pursuing any transaction or that any transaction, if pursued, will be completed on attractive terms or at all. We aim
to run this process into mid-April 2022. If the strategic process is unsuccessful, our Board may decide to pursue a dissolution and liquidation. In the event
of such liquidation or other wind-down event, holders of our securities will likely suffer a total loss of their investment.
As of the date of this Annual Report on Form 10-K and given the strategic process we are running, our active development initiatives are extremely limited.
Financial Overview
Revenue
We have recently begun to generate collaboration revenue but have not generated and do not expect to generate any revenue from the sale of products in the
near future, if at all. If our development efforts for our current product candidates or additional product candidates that we may develop in the future are
successful and can be commercialized, or if we enter into future collaboration or license agreements with third parties, we may generate revenue in the
future from a combination of product sales or payments from such collaboration or license agreements.
The collaboration revenue recognized in 2020 and 2021 relates to a research collaboration with Janssen’s World Without Disease Accelerator, part of the
Janssen Pharmaceutical Companies of Johnson & Johnson. The collaboration explores the potential for Kaleido’s Microbiome Metabolic Therapies
(MMT™) to prevent the onset of childhood allergy and other atopic, immune and metabolic conditions by driving specific microbiome features which
support an appropriate maturation of the infant immune system. We do not expect the total revenue under this arrangement to be material in the aggregate.
Research and Development Expenses
Research and development expenses consist primarily of costs incurred in connection with the discovery and development of our product candidates. These
expenses include:
•
development and operation of our proprietary product platform;
•
employee-related expenses, including salaries, related benefits and stock-based compensation expense, for employees engaged in research
and development functions;
•
expenses incurred in connection with the preclinical and clinical development of our product candidates, including under agreements with
third parties, such as consultants and contract research organizations, or CROs;
•
the cost of laboratory supplies and acquiring, developing and manufacturing products for use in our preclinical studies, clinical studies and
clinical trials, including under agreements with third parties, such as consultants and contract manufacturing organizations, or CMOs;
•
facilities, depreciation and other expenses, which include direct or allocated expenses for rent and maintenance of facilities and insurance;
and
•
costs related to compliance with regulatory requirements.
We expense research and development costs as incurred. Advance payments that we make for goods or services to be received in the future for use in
research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services
are performed.
95
Our direct external research and development expenses are tracked on a program-by-program basis and consist of costs that include fees, reimbursed
materials and other costs paid to consultants, contractors, CMOs and CROs in connection with our preclinical and clinical development and manufacturing
activities. We do not allocate employee costs, costs associated with our discovery efforts, laboratory supplies and facilities expenses, including depreciation
or other indirect costs, to specific product development programs because these costs are deployed across multiple programs and our platform technology
and, as such, are not separately classified.
Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development,
primarily due to the increased size and duration of later-stage clinical trials. We expect that our research and development expenses will increase
substantially in connection with our planned preclinical and clinical development activities in the near term and in the future. At this time, we cannot
accurately estimate or know the nature, timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of any of
our product candidates. The successful development and commercialization of our product candidates is highly uncertain. This is due to the numerous risks
and uncertainties associated with product development and commercialization, including the following:
•
the timing and progress of preclinical and clinical development activities;
•
the number and scope of programs we decide to pursue and their regulatory paths to market;
•
raising additional funds necessary to complete preclinical and clinical development of and commercialize our product candidates;
•
the progress of the development efforts of parties with whom we have entered into and may enter into collaboration arrangements;
•
our ability to maintain our current research and development programs and to establish new ones;
•
our ability to maintain existing and establish new licensing or collaboration arrangements;
•
the successful initiation and completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to the FDA or any
comparable foreign regulatory authority;
•
the receipt and related terms of regulatory approvals from applicable regulatory authorities for any product candidates for therapeutic
indications;
•
the availability of specialty raw materials for use in production of our product candidates;
•
establishing agreements with third-party manufacturers for clinical supply for our clinical trials and commercial manufacturing, if any of our
product candidates is approved or commercialized on an alternate regulatory pathway;
•
meeting demand in a timely fashion with sufficient supply at appropriate quality levels;
•
our ability to obtain and maintain patents, trade secret protection and regulatory exclusivity, both in the United States and internationally;
•
our ability to protect our rights in our intellectual property portfolio;
•
the commercialization of our product candidates, if and when approved if approval to market is required;
•
obtaining and maintaining third-party insurance coverage and adequate reimbursement;
•
the acceptance of our product candidates, if commercialized, by patients, consumers, the medical community and third-party payors;
•
competition with other products; and
•
a continued acceptable safety profile of our therapies following commercialization.
96
A change in the outcome of any of these variables with respect to the development of our product candidates could significantly change the costs and
timing associated with the development of that product candidate. We may never succeed in obtaining regulatory approval or commercialization for any of
our product candidates.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries and related costs, including stock-based compensation, for personnel in executive,
finance, corporate and business development and administrative functions. General and administrative expenses also include legal fees relating to patent
and corporate matters; professional fees for accounting, auditing, tax and administrative consulting services; insurance costs; administrative travel
expenses; and facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other
operating costs.
We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our continued research
activities and development of our product candidates.
Results of Operations
Comparison of Years Ended December 31, 2021 and 2020
The following table summarizes our results of operations for the years ended December 31, 2021 and 2020:
Year Ended December 31,
2021
2020
Change
(in thousands)
Revenue:
Collaboration Revenue
$
1,104 $
975 $
129
Operating expenses:
Research and development
67,803
55,967
11,836
General and administrative
20,968
23,882
(2,914)
Total operating expenses
88,771
79,849
8,922
Loss from operations
(87,667)
(78,874)
(8,793)
Other income (expense)
Interest income
72
249
(177)
Interest expense
(2,838)
(2,802)
(36)
Other expense
145
(193)
338
Total other income (expense), net
(2,621)
(2,746)
125
Net loss
$
(90,288) $
(81,620) $
(8,668)
Research and Development Expenses
Year Ended December 31,
2021
2020
Change
(in thousands)
Personnel-related
$
16,284 $
15,585 $
699
Stock-based compensation expense
4,451
3,820
631
External manufacturing and research
23,823
16,537
7,286
Laboratory supplies and research materials
2,560
2,060
500
Professional and consulting fees
9,140
7,149
1,991
Facility-related and other
11,545
10,816
729
Total research and development expenses
$
67,803 $
55,967 $
11,836
Research and development expenses increased by $11.8 million for the year ended December 31, 2021 as compared to the same period in 2020. The
increase in external manufacturing and research of $7.3 million was primarily due to an increase in production of material for use in our clinical studies.
The increase in professional and consulting fees of $2.0 million was primarily the result of increased spend related to our studies.
97
General and Administrative Expenses
Year Ended December 31,
2021
2020
Change
(in thousands)
Personnel-related
$
5,068 $
6,081 $
(1,013)
Stock-based compensation expense
5,891
8,864
(2,973)
Professional and consulting fees
3,913
3,559
354
Facility-related and other
6,096
5,378
718
Total general and administrative expenses
$
20,968 $
23,882 $
(2,914)
General and administrative expenses decreased by $2.9 million for the year ended December 31, 2021 as compared to the same period in 2020. The
decrease in personnel-related costs of $1.0 million was primarily due to reduced headcount in our general and administrative functions. The decrease in
stock-based compensation expense of $3.0 million was primarily due to the modification of the vesting provision of stock options and restricted stock units
related to the resignation of our former CEO in July 2020.
Interest Income
Interest income for the year ended December 31, 2021 was $0.1 million compared to $0.2 million in the year ended December 31, 2020. Interest income
decreased primarily as a result of lower average cash balance during 2021 and lower interest rates due to market conditions. Interest income in future
periods will fluctuate based upon the amount of invested cash available and interest rates.
Interest expense
Interest expense for the year ended December 31, 2021 and 2020 was $2.8 million. The 2021 interest expense is related to our credit agreement with
Hercules Capital, Inc.
Liquidity and Capital Resources
Since our inception, we have incurred significant operating losses. We have not yet commercialized any of our product candidates and we do not expect to
generate revenue from sales of any product candidates for several years, if at all. To date, we have primarily financed our operations through the public
offering of our equity securities, private placement of our convertible preferred stock and borrowings of long-term debt. As of December 31, 2021, $22.5
million was outstanding under the debt facility. In March 2019, we completed our IPO, pursuant to which we issued and sold 5,000,000 shares of common
stock. We received aggregate net proceeds of $69.8 million, after deducting underwriting discounts and commissions, but before deducting offering costs
totaling $3.8 million. On June 4, 2020, the Company completed a public offering (the “Offering”), pursuant to which it issued and sold 4,750,000 shares of
the common stock. The aggregate net proceeds received by the Company from the Offering were $34.5 million, including 185,000 shares exercised on July
1, 2020 for the Underwriters’ option. On August 4, 2020, the Company entered into an Equity Distribution Agreement (the “Sales Agreement”) with a sales
agent for the sale of up to $50.0 million of the Company’s shares of common stock, from time to time in an at-the-market public offering (the “ATM”). The
sales agent is entitled to compensation at a fixed commission rate of 3.0% of the gross proceeds from the sale of the Company’s common stock pursuant to
the Sales Agreement. During the year ended December 31, 2020, the Company sold 361,299 shares of its common stock under the ATM which resulted in
aggregate net proceeds of $3.4 million after payment of related commissions. During the year ended December 31, 2021, the Company has sold 309,656
shares of its common stock under the ATM which resulted in aggregate net proceeds of $4.9 million. As of December 31, 2021, there was $41.6 million
available under the ATM.
On February 8, 2021, the Company completed a public offering (the “2021 Offering”) including the Underwriters’ overallotment option, pursuant to which
it issued and sold 6,037,500 shares our common stock for aggregate net proceeds of $65.3 million.
As of December 31, 2021, we had $38.5 million in cash and cash equivalents and an accumulated deficit of $364.5 million. Based on our current operating
plans inclusive of the January 2022 restructuring plan, March 2022 Loan
98
and Security Agreement Amendment, and strategic review process, we have sufficient cash and cash equivalents to fund our operating expenses and capital
expenditures into the beginning of the second quarter of 2022. We will require substantial additional capital to sustain our operations and pursue our growth
strategy, including the development of our MMT candidates. If we fail to raise capital or enter into such agreements as and when needed, we may have to
significantly delay, reduce or eliminate the development and commercialization of one or more of our product candidates or delay our pursuit of potential
in-licenses or acquisitions. These factors raise substantial doubt about our ability to continue as a going concern. For more information, refer to “—
Liquidity and Capital Resources” below and Note 1 to our condensed consolidated financial statements included elsewhere in this Annual Report.
Cash Flows
The following table summarizes our sources and uses of cash for each of the periods presented:
Year December 31,
2021
2020
(in thousands)
Net cash used in operating activities
$
(77,094) $
(61,518)
Net cash used in investing activities
(691)
(4,024)
Net cash provided by financing activities
70,037
40,399
Net decrease in cash, cash
equivalents and restricted cash
$
(7,748) $
(25,143)
Net Cash Used in Operating Activities
During the year ended December 31, 2021, operating activities used $77.1 million of cash, due to our net loss of $90.3 million and net cash used by
changes in our operating assets and liabilities of $0.3 million, partially offset by non-cash charges of $13.5 million. Net cash used by our operating assets
and liabilities primarily consisted a $0.4 million decrease in accrued expenses and other liabilities and a $0.2 million increase in prepaid and other assets,
partially offset by a $0.3 million increase in accounts payable.
During the year ended December 31, 2020, operating activities used $61.5 million of cash, due to our net loss of $81.6 million, partially offset by non-cash
charges of $15.6 million and net cash provided by changes in our operating assets and liabilities of $4.5 million. Net cash provided by our operating assets
and liabilities primarily consisted of a $5.0 million increase in accounts payable, accrued expenses and other liabilities, partially offset by a $0.5 million
increase in prepaid expenses and other assets.
Changes in prepaid expenses and other current assets, accounts payable and accrued expenses and other liabilities were generally due to the advancement
of our research programs and the timing of vendor invoices and payments.
Net Cash Used in Investing Activities
During the years ended December 31, 2021, net cash used in investing activities was $0.7 million due to $1.1 million due to purchases of property and
equipment, partially offset by $0.4 million cash proceeds from sale of property and equipment.
During the years ended December 31, 2020, net cash used in investing activities was $4.0 million, respectively, due to purchases of property and
equipment.
Net Cash Provided by Financing Activities
During the year ended December 31, 2021, net cash provided by financing activities was $70.0 million, consisting primarily of proceeds from the 2021
Offering in February 2021, ATM, and proceeds from the exercise of stock options.
99
During the year ended December 31, 2020, net cash provided by financing activities was $40.4 million, consisting primarily of proceeds from the Offering
in June 2020, proceeds from the sale of shares under the ATM in 2020, and proceeds from the exercise of stock options.
On December 31, 2019, we entered into a Credit Agreement (the “Credit Agreement”) with Hercules Capital, Inc. (the “Lender”). Under the Credit
Agreement, the Lenders extended an initial $22.5 million to us, with the option to draw down an additional $12.5 million if certain milestones and
conditions are met. The Credit Agreement includes an end of term charge equal to 7.55% of the aggregate principal amount of all advances. The end of
term charge is being accrued and recorded to interest expense over the life of the Credit Agreement using the effective interest method.
The Credit Agreement contains customary representations and warranties, events of default and affirmative and negative covenants, including, among
others, covenants that limit or restrict the Borrower’s ability to, among other things, incur additional indebtedness, merge or consolidate, make acquisitions,
pay dividends or other distributions or repurchase equity, make investments, dispose of assets and enter into certain transactions with affiliates, in each case
subject to certain exceptions. As security for its obligations under the Credit Agreement, the Borrowers granted the Lender a first priority security interest
on substantially all of the Borrowers’ assets (other than intellectual property), subject to certain exceptions.
The facility carries a 48-month term with interest only payments on the outstanding principal for the first 18 months, which can be extended to up to 24
months, depending on the achievement of certain performance milestones. The Term Loan will mature in January 2024 and bears an interest rate of equal to
the greater of (a) 9.35% and (b) 9.35% plus the Wall Street Journal prime rate minus 3.25%. The Credit Agreement contains a $15 million Minimum Cash
Covenant and is subject to mandatory prepayment provisions that require prepayment upon the occurrence of a Change in Control event (as defined in the
Credit Agreement). The Credit Agreement was amended on March 25, 2022. See “-Recent Developments.”
Funding Requirements
If we are able to continue as a going concern, over the next several quarters we will focus our activities on key exploratory and clinical studies and clinical
trials which we expect will reduce our overall expense rate. In the periods that follow, assuming the success of our clinical studies and clinical trials, we
anticipate our expenses to increase as we progress towards larger and more pivotal clinical studies and clinical trials of our product candidates, with the
potential for larger clinical studies, clinical trials and associated manufacturing. The timing and amount of our operating expenditures will depend largely
on:
•
the commencement, enrollment or results of the planned clinical studies or clinical trials of our product candidates or any future clinical
studies or clinical trials we may conduct, or changes in the development status of our product candidates;
•
the timing and outcome of regulatory review of our product candidates;
•
our decision to initiate a clinical trial, not to initiate a clinical trial or to terminate an existing clinical trial;
•
changes in laws or regulations applicable to our product candidates, including but not limited to clinical trial requirements for approvals;
•
developments concerning our CMOs;
•
our ability to obtain materials and to produce adequate cGMP compliant product supply for any approved or commercialized product or
inability to do so at acceptable prices;
•
our ability to establish and maintain collaborations, if needed;
•
the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution, for any of our
product candidates for which we obtain marketing approval or identify an alternate regulatory pathway to market;
100
•
the costs involved in prosecuting patent applications and enforcing patent claims and other intellectual property claims;
•
additions or departures of key scientific or management personnel;
•
unanticipated serious safety concerns related to the use of our product candidates; and
•
the terms and timing of any collaboration, license or other arrangement, including the terms and timing of any milestone payments
thereunder.
Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity offerings,
debt financings, collaborations, strategic alliances, and marketing, distribution or licensing arrangements with third parties. To the extent that we raise
additional capital through the sale of equity or convertible debt securities, your ownership interest may be materially diluted, and the terms of such
securities could include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing and preferred equity
financing, if available, may involve agreements that include restrictive covenants that limit our ability to take specified actions, such as incurring additional
debt, making capital expenditures or declaring dividends. If we raise funds through collaborations, strategic alliances or marketing, distribution or licensing
arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product
candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other
arrangements when needed, we may be required to delay, reduce or eliminate our product development or future commercialization efforts, or grant rights
to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Off-Balance Sheet Arrangements
As of December 31, 2021, we did not have any off-balance sheet arrangements as defined under applicable SEC rules.
Critical Accounting Policies and Significant Judgments and Estimates
Our consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States. The preparation of our
consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities,
costs and expenses, and the disclosure of contingent assets and liabilities in our financial statements. We base our estimates on historical experience, known
trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making
judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on
an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.
While our significant accounting policies are described in more detail in Note 2 to our consolidated financial statements, we believe that the following
accounting policies are those most critical to the judgments and estimates used in the preparation of our consolidated financial statements.
Accrued research and development expenses
As part of the process of preparing our consolidated financial statements, we are required to estimate our accrued research and development expenses. This
process involves reviewing open contracts and purchase orders, communicating with our applicable personnel to identify services that have been performed
on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or
otherwise notified of actual costs. The majority of our service providers invoice us in arrears for services performed, on a pre-determined schedule or when
contractual milestones are met; however, some require advance payments. We make estimates of our accrued expenses as of each balance sheet date in the
consolidated financial statements based on facts and circumstances known to us at that time. We periodically confirm the accuracy of these
101
estimates with the service providers and make adjustments, if necessary. Examples of estimated accrued research and development expenses include fees
paid to:
•
vendors in connection with preclinical development activities;
•
CROs and investigative sites in connection with preclinical, human clinical studies and clinical trials; and
•
CMOs in connection with the production of preclinical, human clinical studies and clinical trial materials.
We measure the expense recognized based on our estimates of the services received and efforts expended pursuant to quotes and contracts with multiple
CMOs and CROs that supply, conduct and manage preclinical studies, human clinical studies and clinical trials on our behalf. The financial terms of these
agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments
made to our vendors will exceed the level of services provided and result in a prepayment of the expense. Payments under some of these contracts depend
on factors such as the successful enrollment of patients and the completion of certain milestones. In accruing service fees, we estimate the time period over
which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of
effort varies from the estimate, we adjust the accrual or the amount of prepaid expenses accordingly. Although we do not expect our estimates to be
materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing
of services performed may vary and may result in changes in estimates that increase or decrease amounts recognized in any particular period. To date, there
have not been any material adjustments to our prior estimates of accrued research and development expenses.
Recent Accounting Pronouncements
Refer to Note 2, “Summary of Significant Accounting Policies,” in the accompanying notes to the condensed consolidated financial statements for a
discussion of recent accounting pronouncements.
Emerging Growth Company Status
We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, and we may take advantage of
certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies. We may
take advantage of these exemptions until we are no longer an emerging growth company. Section 107 of the JOBS Act provides that an emerging growth
company can take advantage of the extended transition period afforded by the JOBS Act for the implementation of new or revised accounting standards.
We have elected to use the extended transition period for complying with new or revised accounting standards and, as a result of this election, our financial
statements may not be comparable to companies that comply with public company effective dates. We may take advantage of these exemptions up until the
last day of the fiscal year following the fifth anniversary of our IPO or such earlier time that we are no longer an emerging growth company. We would
cease to be an emerging growth company if we have more than $1.07 billion in annual revenue, we have more than $700.0 million in market value of our
stock held by non-affiliates (and we have been a public company for at least 12 months and have filed one annual report on Form 10-K) or we issue more
than $1.0 billion of non-convertible debt securities over a three-year period.
Item 7A. Qualitative and Quantitative Disclosures about Market Risk
We are a smaller reporting company as defined by Rule 12b‑2 of the Exchange Act and are not required to provide the information required under this item.
102
Item 8. Consolidated Financial Statements and Supplementary Data
KALEIDO BIOSCIENCES, INC. AND SUBSIDIARIES
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firm (PCAOB ID No. 34)
104
Consolidated Balance Sheets
105
Consolidated Statements of Operations
106
Consolidated Statements of Stockholders' Equity
107
Consolidated Statements of Cash Flows
108
Notes to Consolidated Financial Statements
109
103
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the stockholders and Board of Directors of Kaleido Biosciences, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Kaleido Biosciences, Inc. and subsidiaries (the “Company”) as of December 31, 2021
and 2020, the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the two years in the period ended December
31, 2021, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material
respects, the financial position of the Company as of December 31, 2021 and 2020, and the results of its operations and its cash flows for each of the two
years in the period ended December 31, 2021, in conformity with accounting principles generally accepted in the United States of America.
Going Concern
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the
financial statements, the Company has incurred recurring losses from operations and recurring negative operating cash flows that raise substantial doubt
about its ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 1. The financial statements do not
include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial
statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States)
(PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and
regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable
assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor
were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of
internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over
financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and
performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in
the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as
evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ Deloitte & Touche LLP
Boston, Massachusetts
March 31, 2022
We have served as the Company’s auditor since 2017.
104
PART I—FINANCIAL INFORMATION
Item 1. Consolidated Financial Statements
KALEIDO BIOSCIENCES, INC. AND SUBSIDIARIES
Consolidated Balance Sheets
(in thousands, except share and per share data)
As of December 31,
2021
2020
Assets
Current assets:
Cash and cash equivalents
$
38,474 $
46,222
Asset held for sale
254
—
Prepaid expenses and other current assets
3,583
2,499
Total current assets
42,311
48,721
Property and equipment, net
5,665
8,462
Restricted cash
2,161
2,161
Total assets
$
50,137 $
59,344
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$
5,670 $
5,389
Accrued expenses and other current liabilities
7,868
8,636
Current term debt, net of unamortized debt discount
16,144
2,634
Total current liabilities
29,682
16,659
Long term debt, net of unamortized debt discount
5,550
18,375
Other liabilities
4,298
3,814
Total liabilities
39,530
38,848
Commitments and contingencies (Note 7)
Stockholders’ equity:
Preferred shares, $0.001 par value, 10,000,000 authorized;
no shares issued or outstanding
—
—
Common shares, $0.001 par value, 150,000,000 shares
authorized; 42,596,037 and 36,022,811 shares issued and shares outstanding at December 31, 2021
and 2020,
respectively
43
36
Additional paid-in capital
375,031
294,639
Accumulated deficit
(364,467)
(274,179)
Total stockholders' equity
10,607
20,496
Total liabilities and stockholders’ equity
$
50,137 $
59,344
The accompanying notes are an integral part of these consolidated financial statements.
105
KALEIDO BIOSCIENCES, INC. AND SUBSIDIARIES
Consolidated Statements of Operations
(in thousands, except share and per share data)
Years Ended December 31,
2021
2020
Revenue:
Collaboration revenue
$
1,104 $
975
Operating expenses:
Research and development
67,803
55,967
General and administrative
20,968
23,882
Total operating expenses
88,771
79,849
Loss from operations
(87,667)
(78,874)
Other (expense) income:
Interest income
72
249
Interest expense
(2,838)
(2,802)
Other income (expense)
145
(193)
Total other income (expense), net
(2,621)
(2,746)
Net loss
$
(90,288) $
(81,620)
Net loss per share —basic and diluted
$
(2.16) $
(2.44)
Weighted-average common shares outstanding —basic and diluted
41,859,993
33,450,213
The accompanying notes are an integral part of these consolidated financial statements.
106
KALEIDO BIOSCIENCES, INC. AND SUBSIDIARIES
Consolidated Statements of Stockholders’ Equity
(in thousands, except share data)
Common Stock
Additional
Paid-In
Accumulated
Stockholders’
Equity
Shares
Amount
Capital
Deficit
(Deficit)
Balance at January 1, 2020
30,127,846 $
30 $
241,412 $
(192,559 ) $
48,883
Issuance of common stock, net of issuance costs of $2,731
5,296,299
5
37,751
—
37,756
Exercise of stock options
597,416
1
2,789
—
2,790
Stock-based compensation
—
—
12,684
—
12,684
Vesting of restricted shares
1,250
—
3
—
3
Net loss
—
—
—
(81,620 )
(81,620 )
Balance at December 31, 2020
36,022,811
36
294,639
(274,179 )
20,496
Issuance of common stock, net of issuance costs of $4,512
6,347,156
6
69,919
—
69,925
Exercise of stock options
120,293
1
470
—
471
Stock-based compensation
—
—
10,342
—
10,342
Common stock issued upon vesting of restricted stock units, net of 45,102 shares withheld
for employee taxes
105,777
—
(339 )
—
(339 )
Net loss
—
—
—
(90,288 )
(90,288 )
Balance at December 31, 2021
42,596,037 $
43 $
375,031 $
(364,467 ) $
10,607
The accompanying notes are an integral part of these consolidated financial statements.
107
KALEIDO BIOSCIENCES, INC. AND SUBSIDIARIES
Consolidated Statements of Cash Flows
(in thousands)
Years Ended December 31,
2021
2020
Operating activities:
Net loss
$
(90,288 )
$
(81,620 )
Reconciliation of net loss to net cash used in operating activities:
Depreciation and amortization
2,358
1,823
Stock-based compensation
10,342
12,684
Amortization of debt discount
705
696
Non-cash interest expense
181
181
(Gain) loss on disposal of fixed asset
(129 )
167
Changes in operating assets and liabilities:
Prepaid expenses and other assets
(150 )
(459 )
Accounts payable
281
3,301
Accrued expense and other liabilities
(394 )
1,709
Net cash used in operating activities
(77,094 )
(61,518 )
Investing activities:
Purchase of property and equipment
(1,129 )
(4,024 )
Cash proceeds from sale of property and equipment
438
—
Net cash used in investing activities
(691 )
(4,024 )
Financing activities:
Payments of issuance and extinguishment costs related to debt
(20 )
(79 )
Proceeds from exercise of stock options
471
2,790
Payments related to capital lease
—
(68 )
Issuance of common stock, net of issuance costs
69,925
37,756
Net settlement of vested restricted stock units to fund related employee statutory tax withholdings
(339 )
—
Net cash provided by financing activities
70,037
40,399
Net decrease in cash, cash equivalents, and restricted cash
(7,748 )
(25,143 )
Cash, cash equivalents, and restricted cash, beginning of year
48,383
73,526
Cash, cash equivalents, and restricted cash, end of year
$
40,635
$
48,383
Supplemental cash flow information
Interest paid
$
2,133
$
1,925
Supplemental disclosure of non-cash investing and financing activities
Vesting of restricted stock
$
—
$
3
Purchase of property and equipment in accounts payable and accrued expenses
$
—
$
71
Receivables for sale of property and equipment in prepaid expenses and other current assets
$
934
$
—
The accompanying notes are an integral part of these consolidated financial statements.
108
KALEIDO BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
1. Nature of the Business, Basis of Presentation, and Going Concern
Kaleido Biosciences, Inc. and its wholly owned subsidiaries (the “Company”) is a clinical-stage healthcare company that was incorporated in Delaware on
January 27, 2015 and has a principal place of business in Lexington, Massachusetts. The Company was formed to use its differentiated, chemistry-driven
approach to leverage the potential of the microbiome to treat disease and improve human health.
The Company is subject to risks common to companies in the biotechnology industry, including, but not limited to, successful development of technology,
obtaining additional funding, protection of proprietary technology, compliance with government regulations, risks of failure of preclinical studies
(including ex vivo assays), clinical studies and clinical trials, the need to obtain marketing approval for its drug candidates and if applicable, its consumer
products, fluctuations in operating results, economic pressure impacting therapeutic pricing, dependence on key personnel, risks associated with changes in
technologies, development by competitors of technological innovations and the ability to supply sufficient amounts of its Microbiome Metabolic Therapies
(“MMTs”) at an acceptable quality level.
On June 4, 2020, the Company completed a public offering (the “Offering”), pursuant to which it issued and sold 4,750,000 shares of the common stock.
The aggregate net proceeds received by the Company from the Offering were $33.2 million. On July 1, 2020, 185,000 shares were exercised under the
Underwriter’s overallotment option for net proceeds of $1.3 million.
On August 4, 2020, the Company entered into an Equity Distribution Agreement (the “Sales Agreement”) with a sales agent for the sale of up to $50.0
million of the Company’s shares of common stock, from time to time in an at-the-market public offering (the “ATM”). The sales agent is entitled to
compensation at a fixed commission rate of 3.0% of the gross proceeds from the sale of the Company’s common stock pursuant to the Sales Agreement.
During the year ended December 31, 2020, the Company sold 361,299 shares of its common stock under the ATM which resulted in aggregate net proceeds
of $3.4 million after payment of related commissions. During the year ended December 31, 2021, the Company has sold 309,656 shares of its common
stock under the ATM which resulted in aggregate net proceeds of $4.9 million. As of December 31, 2021, there was $41.6 million available under the
ATM.
On February 8, 2021, the Company completed a public offering (the “2021 Offering”) including the Underwriters’ overallotment option, pursuant to which
the Company issued and sold 6,037,500 shares of common stock for net proceeds of $65.3 million.
During the years ended December 31, 2021 and 2020, the Company incurred net losses of $90.3 million and $81.6 million, respectively, and reported cash
used in operations totaling $77.1 million and $61.5 million, respectively. As of December 31, 2021, the Company had cash and cash equivalents of $38.5
million. Management believes the Company has sufficient cash and cash equivalents or borrowing capacity to fund operating expenses and capital
expenditures into the beginning of the second quarter of 2022.
In January 2022, we enacted a restructuring plan to reduce our operations to preserve financial resources, resulting in a reduction of our workforce by up to
20 positions. As a result, we incurred costs of $280,000 that consisted of severance benefits for the affected employees and other restructuring costs.
On March 25, 2022, we entered into an amendment to our Loan and Security Agreement with Hercules, pursuant to which we made an immediate payment
of $15 million of the Tranche 1 Advance without any prepayment penalty. This amendment also extended the interest only period of the term loan through
April 1, 2023 and removed the minimum cash covenant that was previously in place.
Additionally, we have initiated a process to evaluate strategic alternatives in order to maximize shareholder value. There can be no assurance that this
strategic review process will result in us pursuing any transaction or that any transaction, if pursued, will be completed on attractive terms or at all. We aim
to run this process into mid-April 2022.
Based on its recurring losses from operations incurred since inception, expectation of continuing operating losses for the foreseeable future, and need to
raise additional capital to finance its future operations, the Company has
109
concluded that there is substantial doubt regarding the Company’s ability to continue as a going concern within one year after the date that these
consolidated financial statements are issued. These financial statements do not include any adjustments that might result from the outcome of this
uncertainty.
The Company will require substantial additional capital to fund its research and development and ongoing operating expenses. These capital requirements
are expected to be funded through debt and equity offerings as well as possible strategic collaborations with other companies. If the Company is unable to
raise additional funds when needed, it may be required to delay, reduce or eliminate its product development or future commercialization efforts, or grant
rights to develop and market product candidates that the Company would otherwise prefer to develop and market itself.
A novel strain of coronavirus (COVID-19) was first identified in late 2019, and subsequently declared a global pandemic by the World Health Organization
on March 11, 2020. As a result of the outbreak, many companies have experienced disruptions in their operations and in markets served. The Company has
instituted some and may take additional temporary precautionary measures intended to help minimize the risk of the virus to its employees, including
implementing a work-at-home policy, providing flexibility for working parents and suspending all business-related travel.
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States
of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted
accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting
Standards Board (“FASB”).
Principles of Consolidation
The accompanying consolidated financial statements reflect the operations of the Company and its wholly owned subsidiaries. All intercompany accounts
and transactions have been eliminated.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of
revenue and expenses during the reporting periods. Actual results may differ from those estimates.
Cash and Cash Equivalents
Cash includes cash in readily available checking accounts. The Company’s cash deposits on hand at one financial institution often exceed federally insured
limits. Cash equivalents include all highly liquid investments maturing within 90 days from the date of purchase.
Restricted Cash
Restricted cash is cash that is restricted as to withdrawal or use under the terms of certain contractual agreements. The restricted cash consists of cash
collateral for secured letters of credit for the security deposit on the Company’s leased laboratory and office facilities.
110
Concentrations of Credit Risk and of Significant Suppliers
Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents. The Company’s
cash equivalents as of December 31, 2021 consisted only of money market funds. The Company does not believe that it is subject to unusual credit risk
beyond the normal credit risk associated with commercial banking relationships.
The Company relies, and expects to continue to rely, on a small number of vendors to manufacture supplies and raw materials for its development
programs. These programs could be adversely affected by a significant interruption in these manufacturing services or the availability of raw materials.
Property and Equipment
Property and equipment are stated at cost and depreciated using the straight-line method over the estimated useful lives of the respective assets. Laboratory
and office equipment, computer equipment and furniture and fixtures are depreciated over a period of five years, and leasehold improvements are
amortized over the lesser of the asset’s estimated useful life or the remaining lease term. Major additions and betterments are capitalized; maintenance and
repairs, which do not improve or extend the life of the respective assets, are charged to operating expenses as incurred.
Impairment of Long-Lived Assets
Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be
recoverable. When such events occur, the Company compares the carrying amounts of the assets to their undiscounted expected future cash flows. If this
comparison indicates that there is an impairment, the amount of the impairment is calculated as the difference between the carrying value and the fair value.
The Company has not recorded any impairment charges in the periods presented.
Segment Information
Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the
chief operating decision maker, or decision-making group, in making decisions on how to allocate resources and assess performance. The Company’s chief
operating decision maker is the chief executive officer (“CEO”). The Company and CEO view the Company’s operations and manage its business as one
operating segment.
Collaboration Revenue
The Company analyzes its collaboration arrangements to assess whether they are within the scope of ASC Topic 808, Collaborative Arrangements (ASC
808), to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and
exposed to significant risks and rewards that are dependent on the commercial success of such activities. To the extent the arrangement is within the scope
of ASC 808, the Company will assess whether aspects of the arrangement between it and their collaboration partner are within the scope of other
accounting literature. If the Company concludes that some or all aspects of the arrangement represent a transaction with a customer, it will account for
those aspects of the arrangement within the scope of ASC Topic 606, Revenue from Contracts with Customers, the Company applies the five-step model
described below. If the Company concludes that some or all aspects of the arrangement are within the scope of ASC 808 and do not represent a transaction
with a customer, the Company will recognize its allocation of the shared costs incurred with respect to the jointly conducted activities as a component of
the related expense in the period incurred.
The Company recognizes revenue after applying the following five steps:
1)
Identification of the contract, or contracts, with a customer,
2)
Identification of the performance obligations in the contract, including whether they are distinct within the context of the contract
3)
Determination of the transaction price, including the constraint on variable consideration
4)
Allocation of the transaction price to the performance obligations in the contract
5)
Recognition of revenue when, or as, performance obligations are satisfied
111
If a contract is determined to be within the scope of ASC 606 at inception, the Company assesses the goods or services promised within such contract,
determines which of those goods and services are performance obligations, and assesses whether each promised good or service is distinct. Promised
goods and services are considered distinct provided that: (i) the customer can benefit from the good or service either on its own or together with other
resources that are readily available to the customer (that is, the good or service is capable of being distinct) and (ii) the entity’s promise to transfer the good
or service to the customer is separately identifiable from other promises in the contract (that is, the promise to transfer the good or service is distinct within
the context of the contract). In assessing whether a promised good or service is distinct, the Company considers factors such as the research, manufacturing
and commercialization capabilities of the collaboration partner and the availability of the associated expertise in the general marketplace. The Company
also considers the intended benefit of the contract in assessing whether a promised good or service is separately identifiable from other promises in the
contract. If a promised good or service is not distinct, an entity is required to combine that good or service with other promised goods or services until it
identifies a bundle of goods or services that is distinct.
The Company may provide options to additional goods or services in such arrangements exercisable at a customer’s discretion. The Company assesses if
these options provide a material right to the customer and if so, they are considered performance obligations. The identification of material rights requires
judgments related to the determination of the value of the underlying good and services to the option exercise price.
The Company determines transaction price based on the amount of consideration the Company expects to receive for transferring the promised goods or
services in the contract. Consideration may be fixed, variable, or a combination of both. The Company then allocates the transaction price to each
performance obligation based on the relative standalone selling prices (“SSP”). SSP is determined at contract inception and is not updated to reflect
changes between contract inception and when the performance obligations are satisfied. In developing the SSP for a performance obligation, the Company
considers applicable market conditions and relevant entity-specific factors, including factors that were contemplated in negotiating the agreement with the
customer and estimated costs.
If the consideration promised in a contract includes a variable amount, the Company estimates the amount of consideration to which it will be entitled by
using the expected value method or the most likely amount method. The Company includes the unconstrained amount of estimated variable consideration
in the transaction price. The amount included in the transaction price is constrained to the amount for which it is probable that a significant reversal of
cumulative revenue recognized will not occur. At the end of each subsequent reporting period, the Company re-evaluates the estimated variable
consideration included in the transaction price and any related constraint, and if necessary, adjusts its estimate of the overall transaction price.
The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the
performance obligation is satisfied, either at a point in time or over time, and if over time recognition is based on the use of an output or input method.
Amounts received prior to satisfying the revenue recognition criteria are recorded as deferred revenue in the Company’s consolidated balance sheets. If the
related performance obligation is expected to be satisfied within the next twelve months this will be classified in current liabilities. Amounts recognized as
revenue prior to receipt are recorded as other current assets in the Company's balance sheets. If the Company expects to have an unconditional right to
receive the consideration in the next twelve months, this will be classified in other current assets.
Research and Development Costs
Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred in performing research and
development activities, including salaries and bonuses, stock‑based compensation, employee benefits, facilities costs, laboratory supplies, depreciation,
manufacturing expenses and external costs of vendors engaged to conduct preclinical development activities and clinical trials, as well as the cost of
licensing technology.
Upfront payments and milestone payments made for the licensing of technology are expensed as research and development in the period in which they are
incurred. Advance payments for goods or services to be received in the
112
future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered
or the services are performed.
Research and Manufacturing Contract Costs and Accruals
The Company has entered into various research and development and manufacturing contracts. These agreements are generally cancelable, and related
payments are recorded as the corresponding expenses are incurred. The Company records accruals for estimated ongoing costs. When evaluating the
adequacy of the accrued liabilities, the Company analyzes progress of the research studies or clinical trials and manufacturing activities, including the
phase or completion of events, invoices received and contracted costs. Significant judgments and estimates may be required in determining the accrued
balances at the end of any reporting period. Actual results could differ from the Company’s estimates. The Company’s historical accrual estimates have not
been materially different from the actual costs.
Patent Costs
All patent‑related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the
recovery of the expenditure. Amounts incurred are classified as general and administrative expenses.
Income Taxes
Deferred tax assets and liabilities are recognized for the expected future tax consequences of events that have been included in the consolidated financial
statements or tax returns. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and
tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. A valuation allowance is
provided to reduce the deferred tax asset to an amount, which, more likely than not, will be realized.
The Company recognizes the tax benefit from any uncertain tax positions only if it is more likely than not that the tax position will be sustained on
examination by the taxing authorities, based on the technical merits of the position. The tax benefits recognized in the consolidated financial statements
from such a position are measured based on the largest benefit that has a greater than fifty percent likelihood of being realized upon ultimate settlement.
Fair Value Measurements
Certain assets and liabilities are carried at fair value. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a
liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the
measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable
inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy,
of which the first two are considered observable and the last is considered unobservable:
•
Level 1 – Unadjusted quoted prices in active markets that are accessible to the reporting entity at the measurement date for identical assets
and liabilities.
•
Level 2 – Inputs other than quoted prices in active markets for identical assets and liabilities that are observable either directly or indirectly
for substantially the full term of the asset or liability. Level 2 inputs include the following:
•
quoted prices for similar assets and liabilities in active markets
•
quoted prices for identical or similar assets or liabilities in markets that are not active
•
observable inputs other than quoted prices that are used in the valuation of the asset or liabilities (e.g., interest rate and yield curve
quotes at commonly quoted intervals)
•
inputs that are derived principally from or corroborated by observable market data by correlation or other means
113
•
Level 3 – Unobservable inputs for the assets or liability (i.e., supported by little or no market activity). Level 3 inputs include management’s
own assumptions about the assumptions that market participants would use in pricing the asset or liability (including assumptions about risk).
The carrying amount of the Company’s other financial assets and liabilities including cash, accounts payable and long-term debt approximate
fair value because of the relatively short period of time between origination and expected realization or settlement.
Net Loss Per Share
Basic net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock outstanding for the period.
Diluted net loss is computed by adjusting net loss to reallocate undistributed earnings based on the potential impact of dilutive securities. Diluted net loss
per share is computed by dividing the diluted net loss by the weighted average number of shares of common stock outstanding for the period, including
potential dilutive common shares assuming the dilutive effect of common stock equivalents.
The following table presents securities that have been excluded from the computations of diluted weighted-average shares outstanding as they would be
anti-dilutive due to the net losses:
As of December 31,
2021
2020
Options to purchase common stock
7,151,081
6,978,447
Unvested restricted stock units
233,287
316,249
7,384,368
7,294,696
Stock-Based Compensation
For stock-based awards, the Company measures the estimated fair value of the stock-based award on the date of grant and recognizes compensation
expense for those awards over the requisite service period, which is generally the vesting period of the respective award. For stock-based awards with
service-based vesting conditions, the Company records the expense for these awards using the straight-line method. For stock options with performance-
based vesting conditions, the Company records the expense for these awards over the requisite service period using an accelerated attribution method to the
extent the achievement of the performance condition is probable. The Company accounts for forfeitures as they occur.
The Company classifies stock-based compensation expense in its consolidated statements of operations in the same manner in which the award recipient’s
cash compensation costs are classified.
Comprehensive Loss
Comprehensive loss includes net loss as well as other changes in stockholders’ equity that result from transactions and economic events other than those
with stockholders. The Company’s comprehensive net loss equals the reported net loss for all periods presented.
Subsequent events
The Company evaluates events and/or transactions occurring after the balance sheet date and before the issue date of the financial statements to determine
if any of those events and/or transactions require adjustment to or disclosure in the financial statements.
Accounting Pronouncements Issued and Not Yet Adopted
In February 2016, the FASB issued ASU No. 2016-02, Leases (“ASU 2016-02”), which applies to all leases and will require lessees to record most leases
on the balance sheet but recognize expense in a manner similar to the current standard. The Company will use a modified retrospective approach of
adoption for leases.
114
The Company adopted the new leasing standard effective January 1, 2022, using the modified retrospective transition approach and utilizing the effective
date as the date of initial application. As a result, prior periods will be presented in accordance with the previous guidance in ASC 840. The Company has
elected to apply the package of practical expedients requiring no reassessment of whether any expired or existing contracts are or contain leases, the lease
classification of any expired or existing leases, or the capitalization of initial direct costs for any existing leases. In connection with the adoption of ASC
842, the Company will record a lease liability of $36.6 million related to its existing office lease and a corresponding right-of-use asset of $33.9 million.
Existing deferred rent and prepaid rent amounts will be removed from the consolidated balance sheets at the date of adoption. The adoption of the standard
will have a material impact on our consolidated balance sheet but will not have material impact to the Company's consolidated statements of operations or
statement of cash flows.
3. Fair Value Measurements
The following tables set forth by level, within the fair value hierarchy, the assets and liabilities carried at fair value on a recurring basis (in thousands):
Fair Value Measurement as of December 31, 2021
Level 1
Level 2
Level 3
Total
Assets:
Money market funds included within cash
and cash equivalents
$
25,417
—
— $
25,417
Total
$
25,417
—
— $
25,417
Fair Value Measurement as of December 31, 2020
Level 1
Level 2
Level 3
Total
Assets:
Money market funds included within cash
and cash equivalents
$
45,410
—
— $
45,410
Total
$
45,410
—
— $
45,410
The fair value of money market funds was measured by the Company based on quoted market prices. There were no transfers among Level 1, Level 2, or
Level 3 categories in the periods presented.
Financial Instruments Not Recorded at Fair Value The carrying value of cash, cash equivalents, restricted cash, accounts payable and accrued expenses
that are reported on the consolidated balance sheets approximate their fair value due to the short-term nature of these assets and liabilities. The carrying
value of the long-term debt approximates fair value as evidenced by the 2021 amendment to the loan and security agreement and the latest refinancing.
4. Property and Equipment, net
Property and equipment consist of the following (in thousands):
As of December 31,
2021
2020
Laboratory equipment
$
7,438 $
6,843
Office and computer equipment
1,586
1,590
Leasehold improvements
1,922
1,910
Construction in process
190
1,612
Property and equipment – at cost
11,136
11,955
Less accumulated depreciation and amortization
(5,471)
(3,493)
Property and equipment – net
$
5,665 $
8,462
115
Depreciation and amortization expense was $2.4 million and $1.8 million for the years ended December 31, 2021 and 2020, respectively. During the year
ended December 31, 2021, the Company recorded gross fixed asset disposal of $1.6 million and related accumulated depreciation of $0.4 million. The
Company also had a fixed asset sale with proceeds of $1.4 million of which $0.9 million was included in prepaid and other current assets as a receivable.
During the year ended December 31, 2020, the Company recorded gross fixed asset disposal of $1.1 million and related accumulated depreciation of $0.9
million.
116
5. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
As of December 31,
2021
2020
Payroll and benefits
$
1,883 $
2,943
Consulting service
291
1,049
Legal service
100
173
Research and development
4,231
3,010
Deferred revenue
828
498
Interest
181
181
Other
354
782
$
7,868 $
8,636
6. Debt Financing
2019 Credit Agreement
On December 31, 2019, the Company entered into a Credit Agreement (the “Credit Agreement”) with Hercules Capital, Inc. (the “Lender”). Under the
Credit Agreement, the Company borrowed $22.5 million, and the Company has the option to draw down an additional $12.5 million if certain milestones
and conditions are met. The Company incurred fees of $0.3 million, which was paid to the lender on the closing date. These amounts were recorded as a
debt discount and are being amortized as interest expense using the effective interest method over the life of the Credit Agreement. The Credit Agreement
also includes an end of term charge equal to 7.55% of the aggregate principal amount of all advances. The end of term charge, totaling $1.7 million at
December 31, 2019, was recognized as a debt discount and is reflected as a reduction in the carrying value of the debt and recorded in other long-term
liabilities. The debt discount created by the end of term charge is being accreted and will be recognized as additional interest expense over the term of the
Credit Agreement using the effective interest method.
The Credit Agreement contains customary representations and warranties, events of default and affirmative and negative covenants, including, among
others, covenants that limit or restrict the Company’s ability to, among other things, incur additional indebtedness, merge or consolidate, make acquisitions,
pay dividends or other distributions or repurchase equity, make investments, dispose of assets and enter into certain transactions with affiliates, in each case
subject to certain exceptions. As security for its obligations under the Credit Agreement, the Company granted the Lender a first priority security interest
on substantially all of the Company’s assets (other than intellectual property), and subject to certain exceptions.
The outstanding principal under the Credit Agreement has a 48-month term with interest only payments for the first 15 months, which period can be
extended to up to 24 months, depending on the achievement of certain performance milestones. The principal bears an interest rate of equal to the greater of
(i) 8.95% plus the prime rate minus 4.75% and (ii) 8.95%. The Credit Agreement includes mandatory prepayment provisions that require prepayment upon
the occurrence of a change in control event.
117
On June 15, 2020, the Company entered into a Second Amendment to Loan and Security Agreement (the “Amendment”). The Amendment was entered
into for the primary purpose of amending the Credit Agreement as follows: (i) the second tranche of the term loan (the “Term Loan”) is terminated; (ii)
amounts available under Tranche 3 of the Term Loan is increased to $12.5 million from the previous $7.5 million availability amount and its availability
period is extended through December 15, 2021, subject to future approval by the Agent’s investment committee; (iii) the interest-only period is extended
through July 31, 2021; (iv) the interest rate on borrowings is increased by 0.4%, such that the per annum interest rate on outstanding borrowings will be the
greater of (a) 9.35% and (b) 9.35% plus the Wall Street Journal prime rate minus 3.25%; (v) the variable amount and duration of a minimum cash covenant
in the Agreement are amended. The interest rate at December 31, 2020 is 9.35%. The Amendment has been accounted for as a modification and the
Company incurred fees of $79,000, which was paid to the lender on the closing date and were recorded as a debt discount, which will be amortized as
interest expense using the effective interest method.
On April 30, 2021, the Company entered into a Third Amendment to Loan and Security Agreement (the "Third Amendment"). The Third Amendment was
entered into for the primary purpose of amending the Credit Agreement as follows: (i) the interest-only period was extended through January 31, 2022; (ii)
the second tranche for the term loan (the "Term Loan") was reinstated and the related $5 million was available to be drawn at the Company's option on or
before June 1, 2021; and (iii) the Minimum Cash Covenant was reduced from $22.5 million to $15 million. The Company incurred fees of $20,000, which
was paid to the Lender on the closing date and were recoded as debt discount, which will be amortized as interest expense using the effective interest
method. The Company did not exercise its option to drawn down the second tranche of the term loan.
Future principal payments under the Credit Agreement as of December 31, 2021 are as follows (in thousands):
2022
16,724
2023
5,172
2024
604
Total future principal payments
22,500
Less unamortized debt discount
806
Total balance
$
21,694
On March 25, 2022, the Company entered into a Fourth Amendment to Loan and Security Agreement ("the Amendment"). The Amendment was entered
into for the primary purpose of amending the Agreement as follows: (i) an immediate payment of $15 million of the Tranche 1 Advance without
prepayment penalty, (ii) extended the interest only period of the term loan through April 1, 2023, (iii) removed the minimum cash covenant that was
previously in place, and (iv) the ability to drawn down an additional $1.7 million tranche if Kaleido completes either an equity raise or convertible debt
financing of at least $15 million of net cash proceeds following the close of the Amendment. The Company paid the immediate payment of $15 million to
the lender on the closing date.
7. Commitments and contingencies
In March 2018, the Company entered into a non-cancelable ten-year lease agreement for laboratory and office space in Lexington, Massachusetts. In March
2019, the Company exercised its option to lease additional space in the building. The lease expires in 2029, subject to one option to extend the lease for 10
years.
Rent expense for the years ended December 31, 2021 and 2020 was $6.5 million and $6.9 million, respectively. Future minimum lease payments under the
non-cancelable operating leases consisted of the following as of December 31, 2021 (in thousands):
Year Ending December 31,
2022
6,207
2023
6,393
2024
6,584
2025
6,782
2026
6,985
Thereafter
18,517
$
51,468
118
8. Stockholders’ Equity
Stock-based compensation
2019 Stock Incentive Plan
The Company’s 2015 Stock Incentive Plan (the “2015 Plan”) provided for the Company to sell or issue incentive stock options or nonqualified stock
options, restricted stock, and other equity awards to employees, directors and consultants of the Company.
The 2019 Stock Option and Incentive Plan (the “2019 Plan”) became effective in February 27, 2019. Upon effectiveness of the 2019 Plan, the remaining
shares available under the 2015 Plan ceased to be available for issuance and no future issuances will be made under the 2015 Plan.
The 2019 Plan provides for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock units, restricted stock
awards, unrestricted stock awards, cash-based awards and dividend equivalent rights to the Company’s officers, employees, directors and consultants.
Awards generally vest over a period up to 4 years and have a maximum term of 10 years. The number of shares initially reserved for issuance under the
2019 Plan is 2,168,976, has increased on January 1, 2020 and will continue to increase each January 1 thereafter by 4% of the number of shares of the
Company’s common stock outstanding on the immediately preceding December 31 or such lesser number of shares determined by the Company’s board of
directors or compensation committee of the board of directors. There were 3,930,009 shares available for future issuance at December 31, 2021.
2019 Employee Stock Purchase Plan
The 2019 Employee Stock Purchase Plan (the “2019 ESPP”) became effective on February 27, 2019. A total of 180,748 shares of common stock were
reserved for issuance under this plan. In addition, the number of shares of common stock that may be issued under the ESPP automatically increased on
January 1, 2020, and will continue to increase each January 1 thereafter, by the lesser of (i) 542,244 shares of common stock, (ii) 1% of the number of
shares of the Company’s common stock outstanding on the immediately preceding December 31 or (iii) such lesser number of shares as determined by the
administrator of the 2019 ESPP. No shares were issued under the 2019 ESPP in 2019. There were 842,253 shares available for future issuance at December
31, 2021.
Stock Option Valuation
The fair value of stock option grants is estimated using the Black-Scholes option-pricing model. The Company historically has been a private company and
lacks company-specific historical and implied volatility information. Therefore, it estimates its expected stock volatility based on the historical volatility of
a publicly traded set of peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own
traded stock price. For options with service-based vesting conditions, the expected term of the Company’s stock options has been determined utilizing the
“simplified” method for awards that qualify as “plain-vanilla” options. The expected term of stock options granted to non-employees is equal to the
contractual term of the option award. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of
the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never
paid cash dividends and does not expect to pay any cash dividends in the foreseeable future.
The Company typically grants stock options at exercise prices deemed by the Board to be equal to the fair value of the common stock at the time of grant.
In the periods prior to the IPO, the fair value of the common stock has been determined by the Board at each measurement date based on a variety of
different factors, including the results obtained from independent third-party appraisals, the Company’s financial position and historical financial
performance, the status of development of the Company’s programs, the current climate in the marketplace, the illiquid nature of the common stock, the
effect of the rights and preferences of the preferred stockholders, and the
119
prospects of a liquidity event, among others. In the periods following the IPO, the fair value is determined based upon the quoted price of the Company’s
common stock.
The assumptions that the Company used to determine the grant-date fair value of options granted were as follows:
Years Ended December 31,
2021
2020
Expected volatility
87.7% - 89.7%
83.5% - 105.5%
Risk-free interest rate
0.59% - 1.35%
0.15% - 1.41%
Expected term (in years)
5.50-6.43
1.39-6.32
Expected dividend yield
—%
—%
Stock Options Activity
A summary of the Company’s stock option activity and related information is as follows:
Options
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Life (in Years)
Aggregate
Intrinsic
Value
Outstanding as of January 1, 2021
6,978,447 $
8.19
7.5 $
15,565
Granted
1,617,510
7.09
Exercised
(120,293)
3.59
Canceled
(1,324,583)
11.21
Outstanding as of December 31, 2021
7,151,081 $
7.46
5.34 $
473
Options exercisable as of December 31, 2021
4,159,202
7.39
3.24 $
473
Options vested or expected to vest as of December 31, 2021
7,151,081
7.46
5.34 $
473
The weighted-average grant date fair value of the options granted during the years ended December 31, 2021 and 2020 was $5.22 and $5.51 per share,
respectively. As of December 31, 2021, there was $13.4 million of unrecognized compensation expense for stock options, which the Company expects to
recognize over the weighted-average remaining term of 2.62 years.
Restricted Stock Unit Activity
A summary of the Company’s restricted stock unit activity and related information is as follows:
Options
Weighted
Average
Grant Date Fair Value
Per Share
Outstanding as of January 1, 2021
316,249 $
6.76
Granted
180,686
7.24
Released
(150,880)
6.49
Canceled
(112,768)
7.42
Outstanding as of December 31, 2021
233,287 $
7.00
As of December 31, 2021, there was $1.2 million of unrecognized compensation expense for the restricted stock units, which the Company expects to
recognize over the weighted-average remaining term of 2.04 years.
120
Stock- Based Compensation Expense
The Company recorded stock-based compensation expense in the following expense categories of its consolidated statements of operations:
Year Ended December 31,
2021
2020
Research and development
$
4,451 $
3,820
General and administrative
5,891
8,864
$
10,342 $
12,684
On January 20, 2021, the Company entered into a separation agreement with the former Chief Medical Officer and Head of Research and Development of
the Company, which amended an existing employment agreement and provided for changes in the term of service and compensation under the agreement.
The outstanding options and restricted stock units held by the former Chief Medical Officer were modified to accelerate certain vesting provisions and the
period of exercisability. As a result, the Company recorded stock-based compensation expense of $2.0 million related to the incremental fair value of the
modified awards during the first quarter of 2021.
9. Income Taxes
There is no provision for income taxes because the Company has historically incurred net operating losses and maintains a full valuation allowance against
its deferred tax assets. The reported amount of income tax benefit for the years ended December 31, 2021 and 2020 differs from the amount that would
result from applying domestic federal statutory rates to pretax losses primarily because of changes in the valuation allowance, state taxes, and the
generation of research and development credits.
Significant components of the Company’s net deferred tax assets at December 31, 2021 and 2020 are as follows:
Years ended December 31,
2021
2020
Deferred tax assets
Stock-based compensation
$
8,055 $
5,484
Net operating loss carryforwards
103,148
64,939
Credit carryforwards
9,328
7,988
Intangible assets
169
164
Charitable contributions
2
1
Accrued expenses
1,410
1,314
Total deferred tax assets
122,112
79,890
Valuation allowance
(121,932)
(79,610)
Total net deferred tax assets
180
280
Deferred tax liabilities:
Fixed assets
(180)
(280)
Total net deferred tax liability
(180)
(280)
Total deferred tax assets (liability)
$
— $
—
121
A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective income tax rate is as follows:
Years ended December 31,
2021
2020
Federal income tax expense at statutory rate
21.0%
21.0%
Stock compensation expense
(0.8)
(1.1)
Fair value change in warrant liability
—
—
Permanent differences
—
—
Federal research and development credit
1.1
1.2
State research and development credit
0.3
0.6
State income tax, net of federal benefit
25.4
6.0
Other
(0.1)
—
Change in valuation allowance
(46.9)
(27.7)
Effective income tax rate
—%
—%
As of December 31, 2021, the Company had net operating loss (NOL) carryforwards for U.S. federal and state tax purposes of $318.6 million and $348.4
million, respectively. Federal NOLs of $38.8 million, generated before 2018, will begin expiring in varying amounts in 2035 unless utilized and the
remaining NOL of $279.8 million, generated after 2018 will be carried forward indefinitely and could be used up to 80% of taxable income of each future
tax year. The Commonwealth of Massachusetts does not follow federal on NOL carryforwards and as such the Company’s Massachusetts NOLs of $271.6
million will expire in at various times starting in 2035. As of December 31, 2021, the Company also has federal research and development tax credit
carryforwards of approximately $6.5 million, and state research and development tax credit carryforwards of approximately $3.6 million, which may be
available to reduce future tax liabilities, and which expire at various dates through 2040.
The rules dealing with U.S. federal, state and local income taxation are constantly under review by persons involved in the legislative process and by the
IRS and the U.S. Treasury Department. Changes to tax laws (which changes may have retroactive application) could adversely affect our stockholders or
us. We assess the impact of various tax reform proposals and modifications to existing tax treaties in all jurisdictions where we have operations to
determine the potential effect on our business and any assumptions we have made about our future taxable income. We cannot predict whether any specific
proposals will be enacted, the terms of any such proposals or what effect, if any, such proposals would have on our business if they were to be enacted.
Beginning in 2022, the Tax Cuts and Jobs Act of 2017 eliminates the currently available option to deduct research and development expenditures and
requires taxpayers to amortize them over five years. The U.S. Congress is considering legislation that would defer the amortization requirement to future
periods, however, we have no assurance that the provision will be repealed or otherwise modified
Management of the Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets, which are comprised
principally of net operating loss carryforwards research and development tax credit carryforwards and capitalized expenditures. Under the applicable
accounting standards, management has considered the Company’s history of cumulative net losses incurred since inception and its lack of
commercialization of any products or generation of any revenue from product sales since inception and concluded that it is more likely than not that the
Company will not recognize the benefits of its federal and state deferred tax assets.
Accordingly, a full valuation allowance has been established, and the valuation allowance increased $42.3 million and $22.8 million in the years ended
December 31, 2021 and 2020, respectively.
Utilization of the net operating loss and research and development credit carryforwards may be subject to a substantial annual limitation under Section 382
of the Code due to ownership change limitations that have occurred previously or that could occur in the future. These ownership changes may limit the
amount of net operating loss and research and development credit carryforwards that can be utilized annually to offset future taxable income and tax,
respectively. The Company has not completed a study to assess whether a change of ownership has occurred, or
122
whether there have been multiple ownership changes since its formation, due to the significant cost and complexity associated with a study. There could
also be additional ownership changes in the future which may result in additional limitations on the utilization of net operating loss carryforwards and tax
credits.
The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business, the Company is
subject to examination by federal and state jurisdictions, where applicable. There are currently no pending tax examinations. Since the Company is in a loss
carryforward position, it is generally subject to examination by the U.S. federal, state, and local income tax authorities for all tax years in which a loss
carryforward is available.
The Company’s policy is to record estimated interest and penalties related to uncertain tax positions in income tax expense. The Company has no amounts
recorded for any unrecognized tax positions, accrued interest or penalties as of December 31, 2021 and 2020.
10. Revenue
In December 2019, the Company entered into a research collaboration agreement with Janssen’s World Without Disease Accelerator (“Janssen”), part of
the Janssen Pharmaceutical Companies of Johnson & Johnson, to explore the potential for a MMT to prevent the onset of childhood allergy and other
atopic, immune and metabolic conditions.
The collaboration includes three milestones of research and development with results of those efforts due to Janssen at end of the milestone at which point
Janssen will have 60 days to decide to proceed with the next milestone.
The Company assessed the Janssen collaboration agreement in accordance with ASC 808 and ASC 606 and concluded that the arrangement represents a
contract with a customer and is within the scope of ASC 606. The promised goods and services represent one combined performance obligation and the
entire transaction price will be allocated to that single combined performance obligation. In addition, the Company concluded the right to proceed with the
following milestones does not provide any discounts to Janssen if it decides to proceed with the next milestones. As such, the Company concluded the
milestone is not considered to be a material right. Each milestone is considered a separate contract and reflects applicable standalone selling prices.
Under the Janssen collaboration agreement, Janssen is obligated to reimburse the Company for the costs incurred under an agreed upon research plan. Costs
incurred are billed by the Company to Janssen at completion of each milestone. The Company recognizes revenue over the research period and as the
performance obligation is satisfied. using total estimated hours to be incurred throughout each milestone. For the year ended December 31, 2021, the
Company recognized $1.1 million as collaboration revenue under the agreement. Further, as of December 31, 2021, the Company recorded $828 as
deferred revenue within other current liabilities on the Company’s consolidated balance sheets related to the Janssen collaboration agreement. The expected
research term of this arrangement is expected to be completed in the second half of 2022, and the aggregate consideration is not expected to be material.
123
Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure
None.
Item 9A. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer (our principal executive officer and principal financial
officer, respectively), evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2021. The term “disclosure controls and
procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act means controls and other procedures of an issuer that are designed to
ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Exchange Act is recorded, processed,
summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation,
controls and procedures designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Exchange
Act is accumulated and communicated to the issuer’s management, including its principal executive and principal financial officers, or persons performing
similar functions, as appropriate to allow timely decisions regarding required disclosure.
Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving
their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on
the evaluation of our disclosure controls and procedures as of December 31, 2021, our Chief Executive Officer and Chief Financial Officer concluded that,
as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Internal Control over Financial Reporting
Management’s Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a-15(f) under the
Exchange Act. Internal control over financial reporting is a process designed by, or under the supervision of, our Principal Executive Officer and Principal
Financial Officer, and effected by our board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of
financial reporting and the preparation of financial statements for external purposes in accordance with GAAP, including those policies and procedures that:
(i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect our transactions and the disposition of our assets, (ii) provide
reasonable assurance that transactions are recorded as necessary to permit preparation of consolidated financial statements in accordance with GAAP and
that receipts and expenditures are being made only in accordance with authorizations of our management and board of directors, and (iii) provide
reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of our assets that could have a material effect
on the consolidated financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of
compliance with policies and procedures may deteriorate.
Management evaluates the effectiveness of our internal control over financial reporting based on the 2013 framework in Internal Control — Integrated
Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this evaluation, management concluded
that our internal control over financial reporting was effective as of December 31, 2021.
124
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d‑15(f) under the Exchange Act) that occurred
during the quarter ended December 31, 2021 that have materially affected, or are reasonably likely to materially affect, our internal control over financial
reporting.
Item 9B. Other Information
None.
125
PART III
Item 10. Directors, Executive Officers and Corporate Governance
The following table sets forth information about our directors, executive officers and other key employees as of March 31, 2022.
NAME
AGE
POSITION(S)
Executive Officers
Daniel L. Menichella
62
President, Chief Executive Officer and Director
William Duke, Jr.
49
Chief Financial Officer
Johan van Hylckama Vlieg, Ph.D.
53
Chief Scientific Officer
Non-Employee Directors
Theo Melas-Kyriazi (1)(2)
62
Chairman of the Board of Directors
Bonnie Bassler, Ph.D. (3)
59
Director
Jean Mixer (1)(2)
55
Director
Anne Prener, M.D.,
Ph.D. (1)(3)
64
Director
Anthony G. Quinn, M.D.,
Ph.D. (2)
60
Director
Member of our audit committee
Member of our compensation committee
Member of our nominating and corporate governance committee
Executive Officers
Daniel L. Menichella has served as our Chief Executive Officer and President and as a Director since October 2020. Prior to becoming Chief Executive
Officer, he served as the chief executive officer for CureVac Inc.’s U.S. subsidiary in January 2017 before taking over as CEO of the international company
in June 2018. Prior to that, Mr. Menichella was Chief Business Officer at several companies, including Bamboo Therapeutics Inc. from 2015-2016,
Applied Genetic Technologies Corporation (AGTC) from 2013-2015 and Zyngenia, Inc. from 2011-2013. Mr. Menichella also led Business Development
and Corporate Strategy functions at Talecris Biopharmaceuticals from 2007-2011 and at Merck KGaA from 2002-2007. He earned his Bachelor of Arts
from Harvard University and his Master of Business Administration from the University of North Carolina at Chapel Hill. We believe that Mr. Menichella
is qualified to serve on our board of directors based on our review of his experience, qualifications, attributes and skills, including experience in operations
management and executive leadership.
William Duke, Jr. has served as our Chief Financial Officer since November 2019. Prior to joining us, Mr. Duke served as the chief financial officer for
Pulmatrix, Inc from June 2015 to November 2019. Prior to Pulmatrix, Mr. Duke served as the Chief Financial Officer of Valeritas, Inc. a medical
technology company, from January 2014 until June 2015 and from July 2011 until January 2014, he served as Valeritas’ Vice President and Corporate
Controller. At Valeritas, Mr. Duke led the controller relationship, financial planning and analysis, investor relations and information technology functions.
Prior to joining Valeritas, Mr. Duke was Senior Director, Finance for Genzyme Corporation, a biopharmaceutical company, from January 2010 to July
2011, where he had oversight responsibility for external reporting to the Securities and Exchange Commission, internal management reporting and
worldwide financial consolidation. Prior to Genzyme, he was the Director of Finance and Accounting of Haemonetics Corporation, a medical device
company, from May 2008 to January 2010 and held various senior financial roles with consulting services and emerging growth organizations. Mr. Duke
holds a B.S. in Accounting from Stonehill College and a M.B.A. with a concentration in Finance from Bentley University and is a Certified Public
Accountant.
Johan van Hylckama Vlieg, Ph.D. has served as our Chief Scientific Officer since July 2019. Dr. van Hylckama Vlieg has 25 years of experience leading
teams and R&D programs in gut microbiology, probiotics and live biotherapeutics, and industrial biotechnology in industry and academia. Most recently,
he served as Vice President for Microbiome and Human Health Innovation at Chr. Hansen in Denmark, responsible for new strain development
126
(1)
(2)
(3)
for probiotic and therapeutic application, spanning discovery to clinical development and novel technology platforms. Previously, Dr. van Hylckama Vlieg
worked at Danone Research and in several roles at NIZO Food Research. He completed his Ph.D. and post-doc in biochemistry at the University of
Groningen in the Netherlands.
Non-Employee Directors
Theo Melas-Kyriazi has served as a Director for our company since July 2019. Mr. Melas-Kyriazi has served as Chief Financial Officer of Levitronix
Technologies Inc. and its predecessor companies since 2006. Levitronix Technologies Inc. manufactures and sells magnetically-levitated pumps primarily
to microelectronics and life sciences customers. Mr. Melas-Kyriazi also serves as an Executive Partner at Flagship Pioneering, an innovation enterprise that
conceives, creates, resources and grows first-in-category life sciences companies, which he joined in April 2019. Mr. Melas-Kyriazi has served as a board
member of Evelo Biosciences, Inc. since 2017 and of Codiak Biosciences, Inc. since 2019. He also served as a director at Valeant Pharmaceuticals
International, Inc from 2003 to 2016. From 1986 to 2004, Mr. Melas-Kyriazi served in a variety of management roles at Thermo Fisher Scientific. Mr.
Melas-Kyriazi received his M.B.A. from Harvard Business School. We believe Mr. Melas-Kyriazi's extensive financial and business experience in life
sciences companies qualifies him to serve on our board of directors.
Bonnie L. Bassler, Ph.D. has served as a Director of our company since December 2018. Dr. Bassler currently serves in several roles at Princeton
University, including, Chair of the Department of Molecular Biology since 2013, associated faculty member of the Department of Chemistry since 2010,
Director for Recruiting and Diversity in the Sciences since 2008, investigator at the Howard Hughes Medical Institute since 2005, professor in the
Department of Molecular Biology since 1994 and associate faculty member of the Princeton Environmental Institute since 1996. Previously, Dr. Bassler
served as the Director of the Council on Science and Technology at Princeton University from July 2008 to June 2013. Dr. Bassler has served as a board
member of Regeneron Pharmaceuticals, Inc. since 2016, a board member of Cidara Therapeutics since 2021, as a Trustee of the Alfred P. Sloan Foundation
since 2014, and previously served as a board member of Sanofi from November 2014 to September 2016. Dr. Bassler served as a board member of the
American Association for the Advancement of Science from January 2012 to December 2016. She was a member of the National Science Board from
January 2010 until May 2016. She received a B.S. in biochemistry from the University of California-Davis and a Ph.D. in biochemistry from John Hopkins
University. We believe that Dr. Bassler is qualified to serve on our board of directors based on our review of her experience, qualifications, attributes and
skills, including her extensive experience in scientific research roles at elite universities.
Jean Mixer has served as a Director of our company since October 2019. Ms. Mixer has more than 25 years of experience in healthcare and 15 years
serving on public company boards. She is founder and CEO of mixerconsulting. Ms. Mixer was Chief Digital Transformation Officer and Vice President
Strategy, at Boston Children’s Hospital, a Harvard affiliate from 2014 to 2020. Prior to that, she was a partner at the Boston Consulting Group, a global
strategy consulting firm where she worked for over a decade. Ms. Mixer has broad experience across the healthcare value chain, including working with
executive management and Boards of leading biopharmaceutical, pharmacy/PBMs, medical device and digital health companies, and as well as providers
and payers. She began her career at J.P. Morgan in New York. Ms. Mixer previously served on the Board of Directors of NxStage Medical, Inc. from 2012
to 2019, when it was acquired for $2 billion. She received a master’s degree in Management from the Kellogg School of Management, Northwestern
University. We believe Ms. Mixer’s extensive experience with respect to strategy, mergers and acquisitions, finance, leadership, and governance qualifies
her to serve on our board of directors.
127
Anne Prener, M.D., Ph.D. has served as a Director of our company since April 2020. Dr. Prener is currently a Venture Partner at SV Health Investors since
September of 2020 and President and CEO of Imbria Pharmaceuticals since July 2020. Dr. Prener has more than 25 years of leadership experience within
life sciences companies and served as CEO and Director of Freeline Ltd. from July of 2017 to June of 2019. Dr. Prener has led companies and teams across
several therapeutic areas, including a focus on rare diseases. Prior to joining Freeline, she served as CEO of Gyroscope Therapeutics Ltd., a gene therapy
company focused on eye diseases, from August 2016 to July 2020. Before that, Dr. Prener was Global Therapeutic Area Head of Hematology and Vice
President, Clinical Research Hematology at Baxalta from October 2014 to July 2016. Earlier in her career, Dr. Prener held several positions of increasing
responsibility at Novo Nordisk, most recently serving as Senior Vice President, Hemophilia R&D Portfolio, where she was instrumental in building a
portfolio of late stage and commercial hemophilia products. Dr. Prener serves on the Boards of Directors of Renovacor, Inc. since January of 2020, Rubius
Therapeutics, Inc. since December 2019 and Galecto, Inc. since January of 2021. Dr. Prener previously served as a director of Gyroscope Therapeutics
Ltd. from July 2017 to March 2020 and of Cellinta Ltd. from March 2020 to June 2020. She holds a Ph.D. in epidemiology and an M.D., both from the
University of Copenhagen. We believe Dr. Prener is qualified to serve on our board of directors because of her medical and clinical experience in the
biopharmaceutical industry, including the scaling of companies from preclinical stage to fully integrated biotechnology organizations.
Anthony G. Quinn, M.D., Ph.D. has served as a Director for our company since February 2016. Currently Dr. Quinn is President and Chief Executive
Officer of Aeglea BioTherapeutics, Inc., a biotechnology company where he has served on the Board of Directors since April 2015, as CEO since July
2018 and as interim CEO from July 2017 to July 2018. Prior to that, from October 2015 to July 2017 he worked as a private consultant for IDBioPharm
Consulting LLC, a consulting firm. From August 2009 to June 2015, Dr. Quinn served as Head of Research & Development and Chief Medical Officer for
Synageva BioPharma Corp., a publicly traded biopharmaceutical company that was acquired by Alexion Pharmaceuticals, Inc. in June 2015. Following the
acquisition, Dr. Quinn worked for Alexion Pharmaceuticals, Inc., a pharmaceutical company, from June 2015 to September 2015. Dr. Quinn received his
BMSc. in general pathology and his MB ChB (M.D.) from the University of Dundee, U.K. and his Ph.D. in cancer research from the University of
Newcastle in Tyne, U.K. He completed a postdoctoral fellowship at University of California, San Francisco before being appointed Professor of
Dermatology at Barts & The London School of Medicine, U.K. He is a fellow of the Royal College of Physicians London. He has also served as a member
of the board of directors for Generation Bio since December 2017. We believe Dr. Quinn is qualified to serve on our board of directors because of his
medical and clinical experience in the biopharmaceutical industry, including the development of therapeutics for rare diseases.
Staggered board
In accordance with the terms of our amended and restated certificate of incorporation and amended and restated by-laws, our board of directors is divided
into three staggered classes of directors and each director is assigned to one of the three classes. At each annual meeting of the stockholders, a class of
directors will be elected for a three-year term to succeed the directors of the same class whose terms are then expiring. The terms of the directors will
expire upon the election and qualification of successor directors at the annual meeting of stockholders to be held in the years 2022 for Class III directors,
2023 for Class I directors and 2024 for Class II directors.
•
Our Class I director is Bonnie L. Bassler;
•
Our Class II directors are Daniel L. Menichella, Jean Mixer and Anthony Quinn; and
•
Our Class III directors are Theo Melas-Kyriazi and Anne Prener.
Our amended and restated certificate of incorporation and amended and restated by-laws provide that the number of directors shall be fixed from time to
time by a resolution of the majority of our board of directors.
The division of our board of directors into three classes with staggered three-year terms may delay or prevent stockholder efforts to effect a change of our
management or a change in control.
128
Family Relationships
There are no family relationships among any of our directors or executive officers.
Section 16(a) Beneficial Ownership Reporting Compliance
Section 16(a) of the Exchange Act requires our directors, executive officers and beneficial owners of more than 10% of our equity securities to file reports
of holdings and transactions in securities of the Company with the SEC. Such reporting persons are required by the SEC regulations to furnish us with
copies of all Section 16(a) reports they file.
Based solely on a review of reports furnished to us, or written representations from reporting persons, we believe all directors, executive officers, and 10%
owners timely filed all reports regarding transactions in our securities required to be filed for 2021 by Section 16(a) under the Exchange Act.
Code of Business Conduct and Ethics
Our board of directors has adopted a Code of Business Conduct and Ethics. The Code of Business Conduct and Ethics applies to all of our employees,
officers (including our principal executive officer, principal financial officer, principal accounting officer or controller or persons performing similar
functions), agents and representatives, including directors and consultants.
The full text of our Code of Business Conduct and Ethics is posted on our website at www.kaleido.com. We intend to disclose future amendments to certain
provisions of our Code of Business Conduct and Ethics on our website. The inclusion of our website address in this Annual Report does not include or
incorporate by reference the information on our website into this Annual Report, and you should not consider that information a part of this Annual Report.
Audit Committee
Our audit committee consists of Theo Melas-Kyriazi, Jean Mixer and Anne Prener and is chaired by Theo Melas-Kyriazi. Our board of directors has
determined that all members of our audit committee meet the requirements for independence and financial literacy for audit committee member under the
applicable rules and regulations of the SEC and the Nasdaq listing rules. Our board of directors has designated each of Theo Melas-Kyriazi and Jean Mixer
as an “audit committee financial expert,” as defined under the applicable rules of the SEC.
Item 11. Executive Compensation
Executive Compensation Overview
As an emerging growth company, we have opted to comply with the executive compensation disclosure rules applicable to “smaller reporting companies,”
as such term is defined in the rules promulgated under the Securities Act. This section provides an overview of the compensation awarded to and earned by
each individual who served as our principal executive officer at any time during our fiscal year ended December 31, 2021 our next two most highly
compensated executive officers in respect of their service to our company for our fiscal year ended December 31, 2021. We refer to these individuals as our
named executive officers. Our named executive officers are:
•
Daniel L. Menichella, our President and Chief Executive Officer
•
William Duke, Jr., our Chief Financial Officer; and
•
Jerald Korn, our Chief Operating Officer and General Counsel;
129
Our executive compensation program has reflected our growth and development-oriented corporate culture. Compensation of our named executive officers
has primarily consisted of a combination of base salary, bonuses and long-term incentive compensation. Our named executive officers, like all of our full-
time employees, are eligible to participate in our health and welfare benefit plans. We currently evaluate our compensation values and philosophy and
compensation plans and arrangements as circumstances require and review executive compensation annually with input from a compensation consultant.
As part of this review process, our board of directors and the compensation committee apply our values and philosophy, while considering the
compensation levels needed to ensure our executive compensation program remains competitive. We also review whether we are meeting our retention
objectives and the potential cost of replacing key employees. We receive input from an outside compensation consultant with respect to compensation paid
to our named executive officers.
Summary Compensation Table
The following table sets forth information regarding compensation awarded to and earned by our named executive officers for services rendered to us in all
capacities during our fiscal years ended December 31, 2021 and 2020.
Name and Principal
Positions
Year
Salary ($)
Cash
Bonus ($)
Option
awards ($) (1)
Non-Equity
Incentive Plan
Compensation $ (2)
All Other
Compensation ($)
Total ($)
Daniel Menichella
2021
$
540,000
$
—
1,156,453
$
162,000 $
16,110 (3) $
1,874,563
President and Chief Executive Officer
(Principal Executive Officer)
2020
118,731 (4)
—
3,777,318
49,044 $
1,978 (5)
3,947,071
William Duke, Jr.
2021
432,600
—
709,773
103,824
11,166 (6)
1,257,363
Chief Financial Officer
(Principal Financial Officer)
2020
420,000
100,000
527,067
142,800
11,142 (7)
1,201,009
Jerald Korn
2021
423,958
—
894,438
104,400
11,385 (8)
1,434,181
Chief Operating Officer and General Counsel
2020
385,165
—
513,629
131,207
10,602 (9)
1,040,603
The amounts reported in the “Option Awards” column reflects the aggregate grant date fair value of share-based compensation awarded during the indicated year computed in accordance
with the provisions of Financial Accounting Standards Board Accounting Standards Codification (ASC) Topic 718. The assumptions used in calculating the grant-date fair value are set
forth in Note 8 to our audited consolidated financial statements appearing elsewhere in this Annual Report.
The amounts reported represent cash incentive compensation based upon the Board’s assessment of the achievement of company and individual performance objectives for the year
indicated. Cash incentive compensation for the years ended December 31, 2021 made in January 2022 and December 31, 2020 made in February 2021.
The amount reported represents $8,000 for matching contributions made in February 2022 by the Company under its 401(k) plan, $480 in long-term disability insurance premiums,
$5,379 in group term life insurance premiums in excess of statutory limits and $2,250 Massachusetts Paid Family and Medical Leave Act.
Mr. Menichella commenced employment with us in October 2020. His annual base salary for 2020 was $540,000.
The amount reported represents $683 for matching contributions made in February 2021 by the Company under its 401(k) plan, $100 in long-term disability insurance premiums, $742 in
group term life insurance premiums in excess of statutory limits and $453 Massachusetts Paid Family and Medical Leave Act.
The amount reported represents $8,000 for matching contributions made in February 2022 by the Company under its 401(k) plan, $480 in long-term disability insurance premiums,
$1,043 in group term life insurance premiums in excess of statutory limits, and $1,643 Massachusetts Paid Family and Medical Leave Act.
The amount reported represents $8,000 for matching contributions made in February 2021 by the Company under its 401(k) plan, $360 in long-term disability insurance premiums,
$1,188 in group term life insurance premiums in excess of statutory limits, and $1,594 Massachusetts Paid Family and Medical Leave Act.
The amount reported represents $8,000 for matching contributions made in February 2022 by the Company under its 401(k) plan, $480 in long-term disability insurance premiums, $800
in group term life insurance premiums in excess of statutory limits, and $2,105 Massachusetts Paid Family and Medical Leave Act..
The amount reported represents $8,000 for matching contributions made in February 2021 by the Company under its 401(k) plan, $480 in long-term disability insurance premiums, $540
in group term life insurance premiums in excess of statutory limits, and $1,582 Massachusetts Paid Family and Medical Leave Act. Mr. Korn resigned from the Company in March 2022.
Narrative to the Summary Compensation Table
Base Salary
Each named executive officer’s base salary is a fixed component of annual compensation for performing specific duties and functions and has been
established by our board of directors taking into account each individual’s role, responsibilities, skills and experience.
130
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
Annual Bonus
Our annual bonus program is intended to reward our named executive officers for meeting objective or subjective performance goals for a fiscal year.
Equity Compensation
Although we do not have a formal policy with respect to the grant of equity incentive awards to our executive officers, or any formal equity ownership
guidelines applicable to them, we believe that equity grants provide our executive officers with a strong link to our long-term performance, create an
ownership culture and help to align the interest of our executive officer and our stockholders. In addition, we believe that equity grants with a time-based
vesting feature promote executive retention because this feature incentives our executive officer to remain in our employment during the vesting period.
Accordingly, our board of directors periodically reviews the equity incentive compensation of our executives, including our names executive officers, and
from time to time may grant equity incentive awards to them in the form of stock options.
We typically grant stock option awards at the start of employment to each executive officer and our other employees as well as on a twice annual basis for
retention purposes. We award our stock options on a future date set by our board of directors at the time the board of director approves the grant. We set the
option exercise price equal to the fair market value of our common stock on the date of the grant.
2019 Stock Option and Incentive Plan
Our 2019 Stock Option and Incentive Plan, or 2019 Plan, was adopted by our board of directors on January 23, 2019, and approved by our stockholders on
February 19, 2019. The 2019 Plan replaced our 2015 Stock Incentive Plan, or 2015 Plan, as our board of directors determined not to make additional
awards under that plan following the consummation of our initial public offering. The 2019 Plan allows the board of directors’ compensation committee to
make equity-based incentive awards to our officers, employees, directors and other key persons (including consultants).
We initially reserved 2,168,976 shares of our common stock for the issuance of awards under the 2019 Plan, or the Initial Limit. The 2019 Plan provides
that the number of shares reserved and available for issuance under the plan will automatically increase each January 1, beginning on January 1, 2020, by
4% of the outstanding number of shares of our common stock on the immediately preceding December 31 or such lesser number of shares as determined by
our compensation committee, or the Annual Increase. These limits are subject to adjustment in the event of a stock split, stock dividend or other change in
our capitalization.
The shares of common stock underlying any awards that are forfeited, cancelled, held back upon exercise or settlement of an award to satisfy the exercise
price or tax withholding, reacquired by us prior to vesting, satisfied without the issuance of stock, expire or are otherwise terminated (other than by
exercise) under the 2019 Plan and 2015 Plan will be added back to the shares of common stock available for issuance under the 2019 Plan.
The maximum aggregate number of shares that may be issued in the form of incentive stock options shall not exceed the Initial Limit cumulatively
increased on January 1, 2020 and on each January 1 thereafter by the lesser of the Annual Increase for such year plus shares added back as provided for
above with respect to the 2015 Plan or 4,337,952 shares of common stock.
131
2015 Stock Incentive Plan
Our 2015 Plan was approved and adopted by our board of directors on July 14, 2015 and approved by our stockholders on July 14, 2015. Under the 2015
Plan we initially reserved for issuance an aggregate of 1,000,000 shares of our common stock, and most recently increased the shares reserved and
available for issuance to 8,395,974 shares of our common stock on December 4, 2018. The number of shares of common stock reserved for issuance under
the 2015 Plan is subject to adjustment in the event of a stock split, reverse stock split, stock dividend, recapitalization, combination of shares,
reclassification of shares, spin-off, or other similar change in our capitalization.
The shares of common stock underlying awards that are forfeited, cancelled, terminated, reacquired prior to vesting, satisfied without the issuance of shares
of common stock, or withheld to cover the exercise price or tax withholding are added back to the shares of common stock available for issuance under the
2019 Plan.
The shares of common stock underlying awards that are forfeited, cancelled, terminated, reacquired prior to vesting, satisfied without the issuance of shares
of common stock, or withheld to cover the exercise price or tax withholding are added back to the shares of common stock available for issuance under the
2019 Plan.
2019 Employee Stock Purchase Plan
On January 23, 2019, our board of directors adopted the 2019 Employee Stock Purchase Plan, or 2019 ESPP, and on February 19, 2019, our stockholders
approved the 2019 ESPP, but the 2019 ESPP has not yet been implemented. The 2019 ESPP is intended to qualify as an “employee stock purchase plan”
within the meaning of Section 423 of the Code. The 2019 ESPP initially reserves and authorizes the issuance of up to a total of 180,748 shares of common
stock to participating employees. The 2019 ESPP provides that the number of shares reserved and available for issuance will automatically increase each
January 1, beginning on January 1, 2020, by the least of (i) 542,244 shares of Common Stock, (ii) 1% of the outstanding number of shares of our common
stock on the immediately preceding December 31 or (iii) such lesser number of shares as determined by the 2019 ESPP administrator. The number of
shares reserved under the 2019 ESPP is subject to adjustment in the event of a stock split, stock dividend or other change in our capitalization.
All employees whose customary employment is for more than 20 hours per week are eligible to participate in the 2019 ESPP. However, any participating
employee who would own 5% or more of the total combined voting power or value of all classes of stock after an option were granted under the 2019
ESPP would not be eligible to purchase shares under the 2019 ESPP.
If implemented, we will make one or more offerings each year to our employees to purchase shares under the 2019 ESPP. Offerings will usually begin on
each May 1 and November 1 and will continue for six-month periods, referred to as offering periods. Each eligible employee may elect to participate in any
offering by submitting an enrollment form at least 15 business days before the relevant offering date.
Each employee who is a participant in the 2019 ESPP may purchase shares by authorizing payroll deductions of up to a specified percentage of his or her
base compensation during an offering period. Unless the participating employee has previously withdrawn from the offering, his or her accumulated payroll
deductions will be used to purchase shares on the last business day of the offering period at a price equal to 85% of the fair market value of the shares on
the first business day or the last business day of the offering period, whichever is lower. Under applicable tax rules, an employee may purchase no more
than $25,000 worth of shares of common stock, valued at the start of the purchase period, under the 2019 ESPP in any calendar year.
The accumulated payroll deductions of any employee who is not a participant on the last day of an offering period will be refunded. An employee’s rights
under the 2019 ESPP terminate upon voluntary withdrawal from the plan or when the employee ceases employment with us for any reason.
The 2019 ESPP may be terminated or amended by our board of directors at any time. An amendment that increases the number of shares of common stock
authorized under the 2019 ESPP and certain other amendments require the approval of our stockholders.
132
Senior Executive Cash Incentive Bonus Plan
In October 2018, our board of directors adopted the Senior Executive Cash Incentive Bonus Plan, or the SECIBP, Plan, but it has not yet been
implemented. The SECIBP provides for cash bonus payments based upon the attainment of performance targets established by our compensation
committee. The payment targets are related to financial and operational measures or objectives with respect to our company, or Corporate Performance
Goals, as well as individual performance objectives. Our compensation committee may select Corporate Performance Goals from among an enumerated list
of corporate performance metrics.
Each executive officer who is selected to participate in the SECIBP will have a target bonus opportunity set for each performance period. The bonus
formulas will be adopted in each performance period by the compensation committee and communicated to each executive. The SECIBP also permits the
compensation committee to approve additional bonuses to executive officers in its sole discretion.
401(k) Plan
Effective as of January 1, 2017, we adopted a tax-qualified retirement plan that provides eligible employees with an opportunity to save for retirement on a
tax-advantaged basis. All participants’ interests in their contributions are 100% vested when contributed. During the first half of 2018, a matching
contribution of 50% of employee contributions up to 6%, with a maximum of $8,000 per year was approved. Matching contributions vest 25% each year,
100% vested after 4 years of service. At the end of the year, contributions are allocated to each participant’s individual account and are then invested in
selected investment alternatives according to the participants’ directions. The retirement plan is intended to qualify under Section 401(a) of the Code.
Limitations on Liability and Indemnification
Our amended and restated certificate of incorporation contains provisions that limit the liability of our directors for monetary damages to the fullest extent
permitted by the Delaware General Corporation Law, or DGCL. Consequently, our directors are not personally liable to us or our stockholders for monetary
damages for any breach of fiduciary duties as directors, except liability for:
•
any breach of the director’s duty of loyalty to us or our stockholders;
•
any act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;
•
unlawful payments of dividends or unlawful stock repurchases or redemptions as provided in Section 174 of the DGCL; or
•
any transaction from which the director derived an improper personal benefit.
Our amended and restated by-laws require us to indemnify our directors and officers to the maximum extent not prohibited by the DGCL and allow us to
indemnify other employees and agents as set forth in the DGCL. Subject to certain limitations, our amended and restated by-laws also require us to advance
expenses incurred by our directors and officers for the defense of any action for which indemnification is required or permitted.
We have entered, and intend to continue to enter, into separate indemnification agreements with our directors, officers and certain of our key employees, in
addition to the indemnification provided for in our amended and restated certificate of incorporation and amended and restated by-laws. These agreements,
among other things, require us to indemnify our directors, officers and key employees for certain expenses, including attorneys’ fees, judgments, penalties,
fines and settlement amounts actually incurred by these individuals in any action or proceeding arising out of their service to us or any of our subsidiaries
or any other company or enterprise to which these individuals provide services at our request. Subject to certain limitations, our indemnification
agreements also require us to advance expenses incurred by our directors, officers and key employees for the defense of any action for which
indemnification is required or permitted.
133
We believe that provisions of our amended and restated certificate of incorporation, amended and restated by-laws and indemnification agreements are
necessary to attract and retain qualified directors, officers and key employees. We also maintain directors’ and officers’ liability insurance.
This description of the indemnification provisions of our amended and restated certificate of incorporation, our amended and restated bylaws and our
indemnification agreements is qualified in its entirety by reference to these documents, each of which is attached as an exhibit to this Annual Report.
At present, there is no pending litigation or proceeding involving any of our directors or executive officers as to which indemnification is required or
permitted, and we are not aware of any threatened litigation or proceeding that may result in a claim for indemnification.
Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, executive officers or persons controlling us, we have
been informed that, in the opinion of the SEC, such indemnification is against public policy as expressed in the Securities Act and is therefore
unenforceable.
Health and Welfare Benefits
All of our full-time employees, including our named executive officers, are eligible to participate in our health and welfare plans, including medical and
dental benefits, short-term and long-term disability insurance, and life insurance. We believe these perquisites are necessary and appropriate to provide a
competitive compensation package to our named executive officers.
Rule 10b5-1 Sales Plans
Our directors and executive officers may adopt written plans, known as Rule 10b5-1 plans, in which they will contract with a broker to buy or sell shares of
our common stock on a periodic basis. Under a Rule 10b5-1 plan, a broker executes trades pursuant to parameters established by the director or officer
when entering into the plan, without further direction from the director or officer. The director or officer may amend or terminate the plan in some
circumstances. Our directors and executive officers may also buy or sell additional shares outside of a Rule 10b5-1 plan when they are not in possession of
material, nonpublic information.
Employment Arrangements and Severance Agreements with our Named Executive Officers
We have entered into employment agreements with each of our named executive officers that provide for specified payments and benefits in connection
with a termination of employment in certain circumstances. Our goal in providing these severance and change in control payments and benefits is to offer
sufficient cash continuity protection such that the named executive officers who are our employees will focus their full time and attention on the
requirements of the business rather than the potential implications for their respective positions. We prefer to have certainty regarding the potential
severance amounts payable to the named executive officers, rather than negotiating severance at the time that a named executive officer’s employment
terminates. We have also determined that accelerated vesting provisions with respect to outstanding equity awards in connection with a qualifying
termination of employment in certain circumstances are appropriate because they encourage our named executive officers to stay focused on the business in
those circumstances, rather than focusing on the potential implications for them personally. The employment agreements with our named executive officers
require the named executive officers to execute a separation agreement containing a general release of claims in favor of us to receive any severance
payments and benefits.
Daniel L. Menichella
On September 29, 2020, we entered into an employment agreement with Mr. Menichella, or the Menichella Employment Agreement. Pursuant to the terms
of the Menichella Employment Agreement, Mr. Menichella serves as our Chief Executive Officer and President on an at-will basis. Mr. Menichella’s
Employment Agreement provides him with a base salary, which is subject to periodic review and adjustment by our board of directors, and eligibility
134
to receive cash incentive compensation as determined by our board of directors or compensation committee from time to time. Mr. Menichella’s current
base salary is $540,000, and Mr. Menichella is eligible for an annual performance bonus currently targeted at 50% of his base salary. Mr. Menichella is also
eligible to participate in the employee benefit plans generally available to our employees, subject to the terms of those plans.
In the event that Mr. Menichella is terminated by the Company without cause or resigns for good reason, Mr. Menichella will be entitled to (i) cash
severance payments in an amount equal to twelve months of Mr. Menichella’s salary existing at the time of his termination plus an amount equal to the
incentive compensation paid to Mr. Menichella during the fiscal year prior to his termination, payable in equal installments on the Company’s normal
payroll cycle, provided that Mr. Menichella does not breach certain restrictive covenants set forth in his employment agreement; (ii) an extension of the
period during which Mr. Menichella can exercise any of his vested options to purchase stock in the Company until the first anniversary of his termination;
and (iii) reimbursement of COBRA premiums for health benefit coverage for him and his immediate family in an amount equal to the monthly employer
contribution that the Company would have made to provide health insurance to Mr. Menichella had he remained employed with the Company for up to
twelve months following the date of termination.
In the event that Mr. Menichella is terminated without cause or resigns for good reason within fifteen months following a “change in control” (as defined in
the Employment Agreement), Mr. Menichella will be entitled to (i) cash severance payments in an amount equal to 1.5 times the sum of (x) twelve months
of Mr. Menichella’s salary existing at the time of his termination, plus (y) his target annual bonus for the year of termination, payable in equal installments
on the Company’s normal payroll cycle; (ii) reimbursement of COBRA premiums for health benefit coverage for him and his immediate family in an
amount equal to the monthly employer contribution that the Company would have made to provide health insurance to Mr. Menichella had he remained
employed with the Company for up to eighteen months following the date of termination; and (iii) the acceleration of vesting of all unvested equity awards
held by Mr. Menichella immediately prior to such termination.
Other Employment Agreements with Executive Officers
In addition to the Menichella Agreement, we have also entered into employment agreements with each of our other executive officers, Messrs. William
Duke, Jr., Johan van Hylckama Vlieg and Jerald Korn. We refer to these agreements collectively as the Executive Employments Agreements.
The current base salaries and discretionary cash incentive bonus amounts for the executives under the Executive Employment Agreements are as follows:
Executive
Title
Base Salary
Target Incentive
Discretionary Bonus (%)
Daniel L. Menichella
Chief Executive Officer
$
540,000
50%
William Duke, Jr.
Chief Financial Officer
432,600
40%
Johan van Hylckama Vlieg
Chief Scientific Officer
394,936
40%
Jerald Korn
Chief Operating Officer and General
Counsel
435,000
40%
Under the Executive Employment Agreements, each of the executives will continue to serve on an at-will basis. The above base salaries are subject to
periodic review and adjustment by our board of directors, and eligibility to receive cash incentive compensation as determined by our board of directors or
compensation committee from time to time. The executives are also eligible to participate in the employee benefit plans generally available to our
employees, subject to the terms of those plans.
The Executive Employment Agreements further provides that if the executive’s employment is terminated by us without Cause (as defined in the relevant
Executive Employment Agreement) or the executive resigns for Good Reason (as defined in the relevant Executive Employment Agreement), then, subject
to the timely execution and effectiveness of a separation agreement, including a general release of claims in our favor, the executive will be entitled to
receive: (i) an amount equal to 12 months of base salary plus an amount equal to the incentive compensation paid to the executive in the year prior to the
year of termination, payable in substantially equal monthly installments over 12 months following termination, (ii) if the executive was enrolled in our
health care
135
program immediately prior to the date of termination and properly elects to receive COBRA benefits, a monthly cash payment for 12 months of COBRA
premiums at our normal rate of contribution for employees for coverage at the level in effect immediately prior to the date of termination and (iii) extension
of the period during which the executive can exercise any of his or her vested options to purchase our stock until the anniversary of the executive’s date of
termination.
In lieu of the severance payments and benefits set forth in the prior paragraph, in the event that the executive is terminated by us without Cause or he or she
resigns for Good Reason, in each case within 15 months following a Change in Control (as defined in the relevant Executive Employment Agreement),
subject to the timely execution and effectiveness of a separation agreement, including a general release of claims in our favor, the executive will be entitled
to receive: (i) a lump sum cash amount equal to 1.5 times the sum of (A) his or her current base salary (or his or her base salary in effect prior to the
Change in Control, if higher) plus (B) his or her target annual cash incentive compensation for the year of termination, (ii) if the executive is enrolled in our
health care program immediately prior to the date of termination and properly elects to receive COBRA benefits, a monthly cash payment for 18 months of
COBRA premiums at our normal rate of contribution for employees for coverage at the level in effect immediately prior to the date of termination, and (iii)
notwithstanding anything to the contrary in any applicable award agreement, accelerated vesting of 100% of all Equity Awards (as defined in the relevant
Executive Employment Agreement) held by the executive.
Each of the Menichella Employment Agreement and the Executive Employment Agreements also contains a Section 280G better-off cutback provision,
which provides that, in the event that the payments or benefits provided to the named executive officer pursuant to his or her employment agreement or
otherwise constitute parachute payments with the meaning of Section 280G of the Code, the payments or benefits to such executive will either be delivered
in full or reduced to the extent necessary to avoid an excise tax under Section 4999 of the Code, whichever would result in the executive receiving the
largest amount of payments or benefits on an after-tax basis. None of the employment agreements with our named executive officers requires us to provide
any tax gross-up payments.
Other agreements
We have also entered into employee confidentiality, inventions, non-solicitation and non-competition agreements with each of our named executive
officers. Under such agreements, each named executive officer has agreed (1) not to compete with us during his or her employment and for a period of one
year after the termination of such employment, (2) not to solicit our employees during his or her employment and for a period of one year after the
termination of such employment, (3) to protect our confidential and proprietary information and (4) to assign to us related intellectual property developed
during the course of his or her employment.
136
Outstanding Equity Awards at 2021 Fiscal Year-End
The following table sets forth information concerning outstanding equity awards held by our named executive officers as of December 31, 2021.
OPTION AWARDS
STOCK AWARDS
NAME
Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
Equity
Incentive Plan
Awards:
Number of
Securities
Underlying
Unexercised
Unearned
Options (#)
Option
Exercise
Price ($)
Option
Expiration
Date
Number
of
Shares Or
Units Of
Stock
That
Have Not
Vested (#)
Market
Value Of
Shares Or
Units Of
Stock That
Have Not
Vested ($)(1)
Equity
Incentive
Plan
Awards:
Number of
Unearned
Shares, Units
or Other
Rights That
Have Not
Vested (#)
Equity
Incentive
Plan
Awards:
Market
or Payout
Value of
Unearned
Shares,
Units or
Other
Rights
That
Have Not
vested ($)
Daniel Menichella,
President and
Chief
Executive
Officer
(Principal
Executive
Officer)
150,000
450,000
(2)
—
8.69
10/14/2030
—
—
—
—
—
90,000
(3 )
—
9.81
3/1/2031
—
—
—
—
—
110,000
(4 )
—
6.29
9/1/2031
—
—
—
—
William Duke, Jr,
Chief
Financial
Officer
(Principal
Accounting
Officer)
135,000 (5 )
135,000
(5 )
—
8.71
11/28/2029
—
—
—
—
18,750 (6 )
31,250
(6 )
—
6.00
4/14/2030
—
—
—
—
12,500 (7 )
37,500
(7 )
—
8.69
10/14/2030
—
—
—
—
— (8 )
60,000
(8 )
—
9.81
3/1/2031
—
—
—
—
—
60,000
(9 )
—
6.29
9/1/2031
—
—
—
—
Jerald Korn, Chief
Operating Officer and
General Counsel
101,250
78,750 (10 )
—
7.67
7/31/2029
—
—
—
—
37,500
37,500 (11 )
—
6.56
11/15/2029
—
—
—
—
16,875
28,125 (12 )
—
6.00
4/15/2030
—
—
—
—
11,250
33,750 (13 )
—
8.69
10/15/2030
—
—
—
—
—
60,000 (14 )
9.81
3/1/2031
—
100,000 (15 )
—
6.29
9/1/2031
—
—
—
—
Unless otherwise specified, all option awards vest over four years, with 25% vesting on the first anniversary of the vesting commencement date, and the
remainder vesting in 12 equal quarterly installments thereafter, subject to continued employment with us.
(1)
The amount represents the number of shares of restricted stock or unvested restricted stock units multiplied by the market value of a share of our common stock based on the closing price
on December 31, 2019, which was $5.02. Unless otherwise specified, all stock awards listed in the table are restricted stock awards.
(2)
The shares underlying this option vest 25% on October 15, 2021, then in 12 equal quarterly installments thereafter.
(3)
The shares underlying this option vest 25% on March 1, 2022, then in 12 equal quarterly installments thereafter.
(4)
The shares underlying this option vest 25% on September 1, 2022, then in 12 equal quarterly installments thereafter.
(5)
The shares underlying this option vest 25% on November 28, 2020, then in 12 equal quarterly installments thereafter.
(6)
The shares underlying this option vest 25% on April 15, 2021, then in 12 equal quarterly installments thereafter.
(7)
The shares underlying this option vest 25% on October 15, 2021, then in 12 equal quarterly installments thereafter.
(8)
The shares underlying this option vest 25% on March 1, 2022, then in 12 equal quarterly installments thereafter.
(9)
The shares underlying this option vest 25% on September 1, 2022, then in 12 equal quarterly installments thereafter.
(10)
The shares underlying this option vest 25% on July 31, 2020, then in 12 equal quarterly installments thereafter.
(11)
The shares underlying this option vest 25% on November 15,2020, then in 12 equal quarterly installments thereafter.
137
(12)
The shares underlying this option vest 25% on April 15, 2021, then in 12 equal quarterly installments thereafter.
(13)
The shares underlying this option vest 25% on October 15, 2021, then in 12 equal quarterly installments thereafter.
(14)
The shares underlying this option vest 25% on March 1, 2022, then in 12 equal quarterly installments thereafter.
(15)
The shares underlying this option vest 25% on September 1, 2022, then in 12 equal quarterly installments thereafter.
Compensation Risk Assessment
We believe that although a portion of the compensation provided to our executive officers and other employees is performance-based, our executive
compensation program does not encourage excessive or unnecessary risk taking.
This is primarily due to the fact that our compensation programs are designed to encourage our executive officers and other employees to remain focused
on both short-term and long-term strategic goals. As a result, we do not believe that our compensation programs are reasonably likely to have a material
adverse effect on us.
Director Compensation
The following table presents the total compensation for each person who served as a non-employee member of our board of directors and received
compensation for such service during the year ended December 31, 2021. Other than as set forth in the table and described more fully below, we did not
pay any compensation, make any additional equity awards or non-equity awards to, or pay any other compensation to any of the non-employee members of
our board of directors in 2021. We reimburse non-employee members of our board of directors for reasonable travel and out-of-pocket expenses incurred in
attending meetings of our board of directors and committees of our board of directors. We also do not, and do not expect to, provide separate compensation
to our directors who are also our employees, such as Mr. Menichella, our Chief Executive Officer and President. Mr. Menichella’s compensation as our
principal executive officer in 2021 is reported above in the Summary Compensation Table.
Director Compensation Table
NAME
Fees Earned Or
Paid In Cash ($)
Stock
Awards ($)
Option Awards
($)(1)
Non-Equity
Incentive Plan
Compensation
All Other
Compensation ($)
Total ($)
Michael Bonney (2)
$
37,917 $
— $
— $
— $
10,204 $
48,121
Bonnie Bassler, Ph.D.
43,000
—
79,730
—
—
122,730
Grady Burnett (3)
46,500
—
79,730
—
—
126,230
Theo Melas-Kyriazi
66,833
—
79,730
—
—
146,563
Jean Mixer
47,500
—
79,730
—
—
127,230
Anne Prener, M.D., Ph.D.
39,000
—
79,730
—
—
118,730
Anthony G. Quinn, M.D., Ph.D.
45,000
—
79,730
—
—
124,730
Geoffrey von Maltzahn, Ph.D. (4)
35,000
—
79,730
—
—
114,730
In accordance with SEC rules, this column reflects the aggregate grant date fair value of the option awards granted during 2021 computed in accordance with Financial Accounting Standard
Board ASC Topic 718 for stock-based compensation transactions, or ASC 718.
Mr. Bonney tendered his resignation from the Board of Directors on August 3, 2021. Other compensation to Mr. Bonney included company paid benefits for medical, dental and vision of
$10,011, $49 long-term disability insurance premiums, and $144 Massachusetts Paid Family and Medical Leave Act.
Mr. Burnett tendered his resignation from the Board of Directors on March 13, 2022. In connection with his resignation from the Board of Directors, Mr. Burnett also resigned from all
committees of the Board of Directors on which he served, including the Nominating and Corporate Governance Committee and the Audit Committee of the Board.
Dr. von Maltzahn tendered his resignation from the Board of Directors on March 15, 2022. At the time of his resignation from the Board of Directors, Dr. von Maltzahn did not serve on any
committees of the Board of Directors.
138
(1)
(2)
(3)
(4)
Non-Employee Director Compensation Policy
Our board of directors has adopted a non-employee director compensation policy, that is designed to enable us to attract and retain, on a long-term basis,
highly qualified non-employee directors. Under the policy, each director who is not an employee will be paid cash compensation, as set forth below:
Member
Annual Fee ($)
Chairman
Additional
Annual Fee ($)
Board of Directors
$
35,000
$
30,000
Audit Committee
7,500
7,500
Compensation Committee
5,000
5,000
Nominating and Corporate Governance Committee
4,000
4,000
Such base compensation is paid on a quarterly basis in arrears.
In addition, subject to the discretion of our board of directors, each non-employee director elected or appointed to our board of directors following the
completion of our initial public offering received an option to purchase a number of shares, with a value equivalent to $440,000, with value determined in
accordance with the reasonable assumptions and methodologies for calculating the fair value of options under ASC 718, on the date of such director’s
election or appointment to the board of directors, which will vest annually over three years, subject to continued service through such vesting dates.
On the date of each annual meeting of stockholders of our company, each non-employee director will also receive an option to purchase a number of shares
that will be determined based on external benchmarking and with input from a compensation consultant, which will vest in full of the earlier to occur of the
first anniversary of the date of grant or the next annual meeting, subject to continued service as a director through such vesting date.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Securities authorized for issuance under equity compensation plans
The following table provides information relating to our equity compensation plans as of December 31, 2021. As of December 31, 2021, we had two equity
compensation plans, our 2019 Plan and our 2019 ESPP, each of which was approved by our board of directors and our stockholders.
Equity Compensation Plans
Number of securities to be
issued upon exercise of
outstanding options,
warrants and right
Weighted-average exercise
price of outstanding
options, warrants, and
rights ($)
Number of securities
remaining available for
future issuance under
equity compensation plans
(excluding securities
reflected in column (a))
(a)
(b)
(c)
Equity compensation plans approved
by stockholders
7,384,368
$
7.46
4,772,262
Equity compensation plans not
approved by stockholders
—
—
—
Total
7,384,368
$
7.46
4,772,262
As described above under "Item 11. Executive Compensation," in connection with our initial public offering, our board of directors and stockholders
approved two new equity compensation plans, the 2019 Plan and the 2019 ESPP. The 2019 Plan and 2019 ESPP became effective on February 27, 2019,
however the 2019 ESPP has not yet been implemented.
139
Security Ownership of Certain Beneficial Owners
The following table sets forth certain information known to us regarding beneficial ownership of our capital stock outstanding as of March 31, 2022 for:
•
each person, or group of affiliated persons, who is known by us to be the beneficial owner of five percent or more of our outstanding
common stock;
•
each of our directors;
•
each of our named executive officers; and
•
all of our current directors and executive officers as a group.
Beneficial ownership is determined in accordance with the rules of the SEC and generally includes voting or investment power with respect to securities.
Under those rules, beneficial ownership includes any shares as to which the individual or entity has sole or shared voting power or investment power and
includes securities that the individual or entity has the right to acquire, such as through the exercise of stock options, within 60 days of March 31, 2022.
Except as noted by footnote, and subject to community property laws where applicable, we believe, based on the information provided to us, that the
persons and entities named in the table below have sole voting and investment power with respect to all common stock shown as beneficially owned by
them.
Each individual or entity shown on the table has furnished information with respect to beneficial ownership. Except as otherwise indicated below, the
address of each officer, director and five percent stockholder listed below is c/o Kaleido Biosciences, Inc., 65 Hayden Avenue, Lexington, MA 02421.
The percentage of beneficial ownership in the table below is based on 42,622,559 shares of common stock deemed to be outstanding as of March 31, 2022.
COMMON STOCK
BENEFICIALLY OWNED
SHARES
PERCENTAGE
5% or Greater Shareholders
Flagship Pioneering Funds (1)
19,575,710
45.9%
FMR LCC (2)
6,389,152
15%
Directors, Named Executive Officers and Other Executive Officer
Daniel L. Menichella (3)
337,700
1%
William Duke, Jr. (4)
272,490
1%
Jerald Korn (5)
255,242
1%
Johan van Hylckama Vlieg (6)
172,020
*
Bonnie Bassler, Ph.D. (7)
55,625
*
Theo Melas-Kyriazi (8)
110,687
*
Jean Mixer (9)
80,084
*
Anne Prener, M.D., Ph.D. (10)
35,000
*
Anthony G. Quinn, M.D.,Ph.D. (11)
77,853
*
All executive officers and directors as a group (9 persons)
1,396,701
3%
* Less than one percent.
(1)
Consists of (a) 2,982,639 shares of common stock held by Flagship Ventures Opportunities Fund I, L.P., (b) 6,560,523 shares of common stock held by Nutritional Health Disruptive
Innovation Fund, L.P., (c) 2,500,000 shares of common stock held by Flagship VentureLabs V, LLC, (d) 216,451 shares of common stock held by Flagship Ventures Fund 2007, L.P., (e)
1,685,444 shares of common stock held by Flagship Ventures Fund IV, LP, (f) 2,560,096 shares of common stock held by Flagship Ventures Fund V, LP, (g) 639,360 shares of common
stock held by Nutritional Health Side Fund, LP, (h) 738,333, shares of common stock held by Nutritional Health LTP Fund, L.P., (i) 42,865 shares of common stock held by Flagship
Venture Labs IV LLC, and (g) 1,649,999 shares of common stock held by Cadena LLC as reported on Schedule 13D/A filed on February 10, 2021.
(2)
The information in the table above concerning the number of shares beneficially owned by FMR LLC was obtained from a Schedule 13G/A filed with the SEC by FMR LLC on February
9, 2021.
140
(3)
Consists of (i) 20,000 shares of common stock held by Mr. Menichella, (ii) 210,000 shares of common stock underlying options exercisable within 60 days of March 31, 2022, and (iii)
70,200 restricted stock units shall vest 100% on April 30, 2022, however, that the grant shall immediately vest as of the date of any change in control of the issuer.
(4)
Consists of (i) 204,375 shares of common stock underlying options exercisable within 60 days of March 31, 2022 and (ii) 44,990 restricted stock units shall vest 100% on April 30, 2022,
however, that the grant shall immediately vest as of the date of any change in control of the issuer.
(5)
Consists of (i) 6,563 shares of common stock held by Mr. Korn, (ii) 203,439 shares of common stock underlying options exercisable within 60 days of March 31, 2022, and (iii) 45,240
restricted stock units shall vest 100% on April 30, 2022, however, that the grant shall immediately vest as of the date of any change in control of the issuer.
(6)
Consists of (i) 6,707 shares of common stock held by Mr. van Hylckama Vlieg and (ii) 149,063 shares of common stock underlying options exercisable within 60 days of March 31, 2022.
(7)
Consists of 55,625 shares of common stock underlying options exercisable within 60 days of March 31, 2022.
(8)
Consists of (i) 33,333 shares of common stock held directly by Mr. Melas-Kyriazi and (ii) 77,354 shares of common stock underlying options exercisable within 60 days of March 31,
2022.
(9)
Consists of 80,084 shares of common stock underlying options exercisable within 60 days of March 31, 2022.
(10)
Consists of 35,000 shares of common stock underlying options exercisable within 60 days of March 31, 2022.
(11)
Consists of (i) 31,603 shares of common stock held directly by Dr. Quinn and (ii) 46,250 shares of common stock underlying options exercisable within 60 days of March 31, 2022.
Communications with the Board of Directors
Stockholders who want to communicate with members of the Board, including the independent directors, individually or as a group, should address their
communications to the Board, the Board members or the Board committee, as the case may be, and send them by mail is c/o Kaleido Biosciences, Inc., 65
Hayden Avenue, Lexington, MA 02421. The Chair of the Audit Committee will forward all such communications directly to such Board members. Any
such communications may be made on an anonymous and confidential basis.
A copy of any such written communication may also be forwarded to the Company’s legal counsel and a copy of such communication may be retained for
a reasonable period of time. The director may discuss the matter with the Company’s legal counsel, with independent advisors, with non-management
directors, or with the Company’s management, or may take other action or no action as the director determines in good faith, using reasonable judgment,
and applying his or her own discretion.
The Audit Committee oversees the procedures for the receipt, retention, and treatment of complaints received by the Company regarding accounting,
internal accounting controls, or audit matters, and the confidential, anonymous submission by employees of concerns regarding questionable accounting,
internal accounting controls or auditing matters. The Company has also established a toll-free telephone number for the reporting of such activity, which is
866-290-6353.
Board Committees
Our board of directors has established an audit committee, a compensation committee and a nominating and corporate governance committee, each of
which operates pursuant to a charter adopted by our board of directors. The composition and functioning of all of our committees complies with all
applicable requirements of the Sarbanes-Oxley Act of 2002, Nasdaq and SEC rules and regulations applicable to us. We intend to comply with future
requirements to the extent they become applicable to us.
The full text of our audit committee charter, compensation committee charter, and nominating and corporate governance charter are posted on the investor
relations portion of our website at www.kaleido.com. We do not incorporate the information contained on, or accessible through, our corporate website into
this Annual Report, and you should not consider it a part of this Annual Report.
141
Item 13. Certain Relationships and Related Transactions, and Director Independence
The following is a description of transactions or series of transactions since January 1, 2019 through the year ended December 31, 2021, to which we were
or will be a party, in which the amount involved in the transaction exceeds, or will exceed, the lesser of $120,000 or one percent of our total assets at
December 31, 2021 and December 31, 2020.
Compensation arrangements for our named executive officers and our directors are described elsewhere in this Annual Report under “Director
Compensation” and “Executive Compensation.”
The Company noted that there were no transactions for the twelve months ended December 31, 2021 and 2020.
Participation in our Initial Public Offering
Certain of our directors, executive officers and our 5% stockholders purchased shares of our common stock in our IPO at the initial public offering price.
The following table sets forth the number of shares of our common stock purchased by directors, executive officers and 5% stockholders and their affiliates
and the aggregate purchase price paid for such shares.
Shares of Common
Stock Purchased
Aggregate Cash
Purchase Price ($)
Flagship Pioneering Funds (1)
933,333 $
13,999,995
(1)
Flagship Pioneering Funds consists of Flagship Ventures Fund V, L.P., Nutritional Health Disruptive Innovation Fund, L.P., and Flagship Ventures Opportunities Fund I, L.P.
Participation in Public Offerings
Certain of our directors, executive officers and our 5% stockholders purchased shares of our common stock in underwritten public offerings of common
stock at the public offering price. The following table sets forth the number of shares of our common stock purchased by directors, executive officers and
5% stockholders and their affiliates and the aggregate purchase price paid for such shares.
June 1, 2020 Public Offering
Shares of Common
Stock Purchased
Aggregate Cash
Purchase Price ($)
Flagship Pioneering Funds (1)
2,000,000 $
15,000,000
Theo Melas-Kyriazi
33,333
249,998
(1)
Flagship Pioneering Funds consists of Flagship Ventures Fund V, L.P., Nutritional Health Disruptive Innovation Fund, L.P., and Flagship Ventures Opportunities Fund I, L.P.
February 3, 2021 Public Offering
Shares of Common
Stock Purchased
Aggregate Cash
Purchase Price ($)
Flagship Pioneering Funds (1)
215,000 $
2,472,500
Daniel L. Menichella
20,000
230,000
(1)
Flagship Pioneering Funds consists of Flagship Ventures Fund V, L.P., Nutritional Health Disruptive Innovation Fund, L.P., and Flagship Ventures Opportunities Fund I, L.P.
Amended and Restated Investors’ Rights Agreement
We are a party to an amended and restated investors’ rights agreement, or the Investors’ Rights Agreement, dated as of February 21, 2018, with certain
holders of our previously outstanding preferred stock, including certain of our 5% stockholders and their affiliates and entities affiliated with certain of our
officers and directors. The Investors’
142
Rights Agreement provides certain of these holders with the right to demand that we file a registration statement or request that their shares be covered by a
registration statement that we are otherwise filing.
Employment Agreements
We have entered into employment agreements with certain of our executive officers. See “Item 11-Executive Compensation—Employment Arrangements
and Severance Agreements with our Named Executive Officers.”
Equity Grants
We have granted stock options and warrants to certain of our executive officers and members of our board of directors. See “Item 11-Executive
Compensation.”
Indemnification Agreements
As permitted by Delaware law, provisions in our amended and restated certificate of incorporation and amended and restated bylaws limit or eliminate the
personal liability of directors for a breach of their fiduciary duty of care as a director. In addition, we have entered into indemnification agreements with
each of our executive officers and the members of our board of directors which may require us to indemnify them. See “Item 11-Executive Compensation
—Limitations on Liability and Indemnification.”
Policies for Approval of Related Party Transactions
Our board of directors has adopted a written related party transactions policy. Pursuant to this policy, the audit committee has the primary responsibility for
reviewing and approving or disapproving “related party transactions,” which are transactions between us and related persons in which the aggregate
amount involved exceeds or may be expected to exceed $120,000 and in which a related person has or will have a direct or indirect material interest. For
purposes of this policy, a related person will be defined as a director, executive officer, nominee for director, or greater than 5% beneficial owner of our
common stock, in each case since the beginning of the most recently completed year, and their immediate family members.
Director Independence
Under the Nasdaq listing rules, independent directors must comprise a majority of a listed company’s board of directors within twelve months from the date
of listing. In addition, the Nasdaq listing rules require that, subject to specified exceptions, each member of a listed company’s audit, compensation and
nominating and governance committees be independent within twelve months from the date of listing. Audit committee members must also satisfy
additional independence criteria, including those set forth in Rule 10A-3 under the Securities Exchange Act of 1934, as amended (the Exchange Act), and
compensation committee members must also satisfy the independence criteria set forth in Rule 10C-1 under the Exchange Act. Under Nasdaq listing rules,
a director will only qualify as an “independent director” if, in the opinion of that company’s board of directors, that person does not have a relationship that
would interfere with the exercise of independent judgment in carrying out the responsibilities of a director. In order to be considered independent for
purposes of Rule 10A-3 under the Exchange Act, a member of an audit committee of a listed company may not, other than in his or her capacity as a
member of the audit committee, the board of directors or any other board committee: (1) accept, directly or indirectly, any consulting, advisory or other
compensatory fee from the listed company or any of its subsidiaries, other than compensation for board service; or (2) be an affiliated person of the listed
company or any of its subsidiaries. In order to be considered independent for purposes of Rule 10C-1, the board of directors must consider, for each
member of a compensation committee of a listed company, all factors specifically relevant to determining whether a director has a relationship to such
company which is material to that director’s ability to be independent from management in connection with the duties of a compensation committee
member, including, but not limited to: the source of compensation of the director, including any consulting advisory or other compensatory fee paid by such
company to the director, and whether the director is affiliated with the company or any of its subsidiaries or affiliates.
143
In February 2019, our board of directors undertook a review of the composition of our board of directors and its committees and the independence of each
director. Based upon information requested from and provided by each director concerning his background, employment and affiliations, including family
relationships, our board of directors has determined that all members of our board of directors, except Michael Bonney, Allison Lawton and Geoffrey von
Maltzahn, are independent directors, including for purposes of Nasdaq and SEC rules. In making that determination, our board of directors considered the
relationships that each director has with us and all other facts and circumstances the board of directors deemed relevant in determining independence,
including the potential deemed beneficial ownership of our capital stock by each director, including non-employee directors that are affiliated with certain
of our major stockholders. There are no family relationships among any of our directors or executive officers.
Committees of our Board of Directors
Our board of directors has established an audit committee, a compensation committee and a nominating and corporate governance committee, each of
which operates pursuant to a written charter adopted by our board of directors. The composition and functioning of all of our committees comply with all
applicable requirements of the Sarbanes-Oxley Act of 2002, Nasdaq and SEC rules and regulations applicable to us.
Audit Committee
As of March 31, 2022, our audit committee consists of Theo Melas-Kyriazi, Jean Mixer and Anne Prener and is chaired by Theo Melas-Kyriazi. Our board
of directors has determined that each member of the committee is “independent” for audit committee purposes as that term is defined in the rules of the
SEC and the applicable Nasdaq rules, and each of the committee members has sufficient knowledge in financial and auditing matters to serve on the audit
committee. Our board of directors has designated each of Theo Melas-Kyriazi and Jean Mixer as an “audit committee financial expert,” as defined under
the applicable rules of the SEC. The functions of the audit committee include:
•
appointing, approving the compensation of and assessing the independence of our independent registered public accounting firm;
•
pre-approving auditing and permissible non-audit services, and the terms of such services, to be provided by our independent registered
public accounting firm;
•
reviewing the overall audit plan with our independent registered public accounting firm and members of management responsible for
preparing our financial statements;
•
reviewing and discussing with management and our independent registered public accounting firm our annual and quarterly financial
statements and related disclosures as well as critical accounting policies and practices used by us;
•
coordinating the oversight and reviewing the adequacy of our internal control over financial reporting;
•
establishing policies and procedures for the receipt and retention of accounting-related complaints and concerns;
•
recommending based upon the audit committee’s review and discussions with management and our independent registered public accounting
firm whether our audited financial statements shall be included in our Annual Report on Form 10-K;
•
monitoring the integrity of our financial statements and our compliance with legal and regulatory requirements as they relate to our financial
statements and accounting matters;
•
preparing the audit committee report required by SEC rules to be included in our annual proxy statement;
•
reviewing all related person transactions for potential conflict of interest situations and approving all such transactions; and
•
reviewing quarterly earnings releases.
144
The audit committee held 5 meetings during 2021. The audit committee operates under a written charter that satisfies the applicable standards of the SEC
and Nasdaq. A copy of the audit committee charter is available on our website at https://investors.kaleido.com/corporate-governance/documents-charters.
We do not incorporate the information contained on, or accessible through, our corporate website into this Annual Report, and you should not consider it a
part of this Annual Report.
Compensation Committee
As of March 31, 2022, our compensation committee consists of Jean Mixer, Theo Melas-Kyriazi and Anthony Quinn, M.D., Ph.D., and is chaired by and
Anthony Quinn, M.D., Ph.D. Our board of directors has determined that each member of the compensation committee is “independent” as defined in the
applicable Nasdaq rule. The functions of the compensation committee include:
•
annually reviewing and recommending to the board of directors the corporate goals and objectives relevant to the compensation of
our Chief Executive Officer;
•
evaluating the performance of our Chief Executive Officer in light of such corporate goals and objectives and based on such
evaluation (i) recommending to the board of directors the cash compensation of our Chief Executive Officer and (ii) recommending
grants and awards to our Chief Executive Officer under equity-based plans;
•
reviewing and approving or recommending to the board of directors the cash compensation of our other executive officers;
•
reviewing and establishing our overall management compensation, philosophy and policy;
•
overseeing and administering our compensation and similar plans;
•
evaluating and assessing potential and current compensation advisors in accordance with the independence standards identified in
the applicable Nasdaq rules;
•
reviewing and approving our policies and procedures for the grant of equity-based awards;
•
reviewing and recommending to the board of directors the compensation of our directors;
•
preparing the compensation committee report required by SEC rules, if and when required, to be included in our annual proxy
statement; and
•
reviewing and approving the retention, termination or compensation of any consulting firm or outside advisor to assist in the
evaluation of compensation matters.
The compensation committee held 5 meetings during 2021. The compensation committee operates under a written charter that satisfies the applicable
standards of the SEC and Nasdaq. A copy of the compensation committee charter is available on our website at https://investors.kaleido.com/corporate-
governance/documents-charters. We do not incorporate the information contained on, or accessible through, our corporate website into this Annual Report,
and you should not consider it a part of this Annual Report.
Nominating and Corporate Governance Committee
As of March 31, 2022, our nominating and corporate governance committee consists of Bonnie L. Bassler and Anne Prener, M.D., Ph.D and is chaired by
Bonnie L. Bassler. The functions of the nominating and corporate governance committee include:
•
developing and recommending to the board of directors criteria for board and committee membership;
•
establishing procedures for identifying and evaluating board of director candidates, including nominees recommended by stockholders;
•
reviewing the composition of the board of directors to ensure that it is composed of members containing the appropriate skills and expertise
to advise us;
•
identifying individuals qualified to become members of the board of directors;
145
•
recommending to the board of directors the persons to be nominated for election as directors and to each of the board’s committees;
•
developing and recommending to the board of directors a code of business conduct and ethics and a set of corporate governance guidelines;
and
•
overseeing the evaluation of our board of directors and management.
The nominating and corporate committee held 1 meeting during 2021. The nominating and corporate committee operates under a written charter that
satisfies the applicable standards of the SEC and Nasdaq. A copy of the nominating and corporate committee charter is available on our website at
https://investors.kaleido.com/corporate-governance/documents-charters. We do not incorporate the information contained on, or accessible through, our
corporate website into this Annual Report, and you should not consider it a part of this Annual Report.
Compensation committee interlocks and insider participation
None of the members of our compensation committee has at any time during the prior three years been one of our officers or employees. None of our
executive officers currently serves, or in the past fiscal year has served, as a member of the board of directors or compensation committee of any entity that
has one or more executive officers serving on our board of directors or compensation committee.
Director Affiliations
Some of our directors are affiliated with and serve on the board of directors as representatives of entities which beneficially own or owned 5% or more of
our common stock, as indicated below:
Name
Principal Stockholder
Theo Melas-Kyriazi
Flagship Pioneering Funds (1)
(1)
Flagship Pioneering Funds consists of Flagship Ventures Fund IV, L.P., Flagship Ventures Fund V, L.P., Nutritional Health Disruptive Innovation Fund, L.P., and Flagship Ventures
Opportunities Fund I, L.P.
Item 14. Principal Accounting Fees and Services
The Audit Committee had selected Deloitte & Touche LLP, or Deloitte, as our independent registered public accounting firm for the fiscal year ended
December 31, 2021. In addition to retaining Deloitte to audit our consolidated financial statements for fiscal 2021, we engaged the firm from time to time
during the year to perform other services.
The following table sets forth the aggregate fees billed by Deloitte in connection with services rendered during the last two fiscal years.
For the Year Ended December 31,
2021
2020
Audit fees
$
526,500 $
536,287
Audit-related fees
—
—
Tax fees
—
—
Other fees
1,895
1,895
$
528,395 $
538,182
Audit Fees consist of fees for professional services rendered in connection with the audit of our annual consolidated financial statements, the review of the
interim consolidated financial statements included in quarterly reports and services that are normally provided by Deloitte, such as comfort letters, in
connection with statutory and regulatory filings or engagements.
Audit-Related Fees consist of fees for accounting consultations and other services that were reasonable related to the performance of audits or reviews of
our financial statements and were not reported above under “Audit Fees”.
146
All Other Fees consist of fees billed for products and services provided by the independent registered public accounting firm other than those disclosed
above.
In fiscal 2021 and 2020, no services other than those discussed above were provided by Deloitte.
The Audit Committee has adopted a policy requiring pre-approval of all audit and non-audit related services to be performed by the Company’s
independent auditor regardless of amount. These services may include audit services, audit-related services, tax services and other related services. Deloitte
and management are required to periodically report to the Audit Committee regarding the extent of services provided by Deloitte in accordance with this
pre-approval and the fees for the services performed to date. The Audit Committee may also pre-approve particular services on a case-by-case basis.
The Audit Committee annually evaluates the qualifications, performance and independence of the Company’s independent registered public accounting
firm. It selected Deloitte as the Company’s independent registered public accounting firm for 2021. This selection was subsequently approved by the board
of directors. The Audit Committee has reviewed and discussed with management and with Deloitte the Company’s audited consolidated financial
statements for the year ended December 31, 2021. In addition, the Audit Committee has discussed with Deloitte the matters that independent registered
public accounting firms must communicate to audit committees under applicable PCAOB standards.
The Audit Committee has also discussed and confirmed with Deloitte its independence from the Company and received all written disclosures and
correspondence required by the PCAOB Ethics and Independence requirements. The Audit Committee has evaluated and concluded the non-audit services
provided by Deloitte to the Company do not impair Deloitte’s independence.
Based on the reviews and discussions referred to above, the Audit Committee recommended to our board of directors that the audited consolidated financial
statements for the year ended December 31, 2021 and the related footnotes be included in the Company’s Annual Report on Form 10-K for the year ended
December 31, 2021.
147
PART IV
Item 15. Exhibits and Financial Statement Schedules
(a)
1. Financial Statements
For a list of the financial statements included herein, see Index to the Consolidated Financial Statements on page 104 of this Annual Report on Form 10-K,
incorporated into this Item by reference.
2. Financial Statement Schedules
Financial statement schedules have been omitted because they are either not required or not applicable or the information is included in the consolidated
financial statements or the notes thereto.
3. Exhibits
The exhibits required by Item 601 of Regulation S-K and Item 15(b) of this Annual Report on Form 10-K are listed in the Exhibit Index below. The
exhibits listed in the Exhibit Index are incorporated by reference herein.
(b)
Exhibit Index
Exhibit No.
Exhibit Index
3.1
Amended and Restated Certificate of Incorporation of the Registrant, dated March 4, 2019 (incorporated by reference to Exhibit 3.1
to the Registrant’s Current Report on Form 8-K (File No. 001-38822) filed on March 4, 2019).
3.2
Amended and Restated By-laws of the Registrant, dated February 27, 2019 (incorporated by reference to Exhibit 3.2 to the
Registrant’s Current Report on Form 8-K (File No. 001-38822) filed on March 4, 2019).
3.3
Amendment to Amended and Restated By-laws of the Registrant, dated May 7, 2020 (incorporated by reference to Exhibit 3.1 to the
Registrant’s Current Report on Form 8-K (File No. 001-38822) filed on May 8, 2020).
4.1
Second Amended and Restated Investors’ Rights Agreement among the Registrant and certain of its stockholders, dated February
21, 2018 (incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement on Form S-1 (File No. 333-229204)
filed on January 11, 2019).
4.2
Specimen Stock Certificate evidencing shares of common stock (incorporated by reference to Exhibit 4.2 to the Registrant’s
Registration Statement on Form S-1/A (File No. 333-229204) filed on February 19, 2019).
4.3
Description of Registrant’s Securities (incorporated by reference to Exhibit 4.3 to the Registrant's Annual Report on Form 10-K
(File No. 001-38822) filed on March 3, 2021.
10.1§
Umbrella Development Services Agreement, by and between Patheon UK Limited and the Registrant, dated September 6, 2018
(incorporated by reference to Exhibit 10.1 to the Registrant’s Registration Statement on Form S-1/A (File No. 333-229204) filed on
February 19, 2019).
10.2#
2015 Stock Incentive Plan and forms of award agreements thereunder (incorporated by reference to Exhibit 10.2 to the Registrant’s
Registration Statement on Form S-1/A (File No. 333-229204) filed on February 19, 2019).
10.3#
2019 Stock Option and Incentive Plan and forms of award agreements thereunder (incorporated by reference to Exhibit 10.3 to the
Registrant’s Registration Statement on Form S-1/A (File No. 333-229204) filed on February 19, 2019).
148
10.4#
Senior Executive Cash Incentive Bonus Plan (incorporated by reference to Exhibit 10.4 to the Registrant’s Registration Statement on
Form S-1/A (File No. 333-229204) filed on February 19, 2019).
10.5#
2019 Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.5 to the Registrant’s Registration Statement on Form
S-1/A (File No. 333-229204) filed on February 19, 2019).
10.6#
Form of Indemnification Agreement between the Registrant and each of its directors (incorporated by reference to Exhibit 10.6 to
the Registrant’s Registration Statement on Form S-1/A (File No. 333-229204) filed on February 19, 2019).
10.7#
Form of Indemnification Agreement between the Registrant and each of its executive officers (incorporated by reference to Exhibit
10.7 to the Registrant’s Registration Statement on Form S-1/A (File No. 333-229204) filed on February 19, 2019).
10.8#
Employment Agreement between the Registrant and Michael Bonney, dated January 24, 2019 (incorporated by reference to Exhibit
10.8 to the Registrant’s Registration Statement on Form S-1/A (File No. 333-229204) filed on February 19, 2019).
10.9#
Employment Agreement between the Registrant and Alison Lawton, dated January 24, 2019 (incorporated by reference to Exhibit
10.9 to the Registrant’s Registration Statement on Form S-1/A (File No. 333-229204) filed on February 19, 2019), as amended by
Amendment to Employment Agreement between Registrant and Alison Lawton, dated July 20, 2020 (incorporated by reference to
Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No 001-38822) filed on July 23, 2020.
10.10#
Employment Agreement between the Registrant and Katharine Knobil, M.D., dated January 24, 2019 (incorporated by reference to
Exhibit 10.11 to the Registrant’s Registration Statement on Form S-1/A (File No. 333-229204) filed on February 19, 2019).
10.11
Employment Agreement between the Registrant and William Duke, Jr., dated December 2, 2019 (incorporated by reference to
Exhibit 10.13 to the Registrant’s Annual Report on Form 10-K (File No. 001-38822) filed on March 2, 2020).
10.12#
Employment Agreement between the Registrant and Daniel Menichella, dated September 30, 2020 (incorporated by reference to
Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-38822) filed on October 1, 2020).
10.13
Lease Agreement by and between HCP/King Hayden Campus LLC and the Registrant, dated March 19, 2018 (incorporated by
reference to Exhibit 10.13 to the Registrant’s Registration Statement on Form S-1 (File No. 333-229204) filed on January 11, 2019).
10.14
Lease Agreement by and between DIV Bedford, LLC and the Registrant, dated May 15, 2017 (incorporated by reference to Exhibit
10.14 to the Registrant’s Registration Statement on Form S-1 (File No. 333-229204) filed on January 11, 2019).
10.15
Credit Agreement, dated December 31, 2019, by and among Kaleido Biosciences, Inc., Cadena Bio, Inc., and Hercules Capital
(incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-38822) filed on January 3,
2020), as amended by that certain First Amendment to Loan and Security Agreement, dated as of April 10, 2020, further amended
by Second Amendment to Loan and Security Agreement, dated as of June 15, 2020 (incorporated by reference to Exhibit 10.1 to the
Registrant’s Current Report on Form 8-K (File No. 001-38822) filed on June 18, 2020), and further amended by Third Amendment
to Loan and Security Agreement, dated April 30, 2021 (incorporated by reference to Exhibit 10.1 to the Registrant's Current Report
on Form 8-K (File No. 001-38822), filed on May 4, 2021.
10.16*
Fourth Amendment to Loan and Security Agreement, dated March 25, 2022.
149
21.1
Subsidiaries of the Registrant (incorporated by reference to Exhibit 21.1 to the Registrant's Annual Report on Form 10-K (File No.
001-38822) filed on March 3, 2021.
23.1 *
Consent of Deloitte and Touche LLP, Independent Registered Public Accounting Firm
31.1*
Certification of Chief Executive Officer, pursuant to Rule 13a-14(a) or 15(d)-14(1) of the Securities Exchange Act of 1934, as
adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2*
Certification of Chief Financial Officer, pursuant to Rule 13a-14(a) or 15(d)-14(1) of the Securities Exchange Act of 1934, as
adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1*†
Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-
Oxley Act of 2002.
32.2*†
Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-
Oxley Act of 2002.
101.INS
Inline XBRL Instance Document.
101.SCH
Inline XBRL Taxonomy Extension Schema Document.
101.CAL
Inline XBRL Taxonomy Calculation Linkbase Document.
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document.
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
* Filed herewith.
† This certification will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or
otherwise subject to the liability of that section. Such certification will not be deemed to be incorporated by reference into any filing under the Securities
Act of 1933, as amended, or the Exchange Act, except to the extent specifically incorporated by reference into such filing.
# Indicates a management contract or any compensatory plan, contract or arrangement.
§ Confidential treatment has been granted with respect to redacted portions of this exhibit. Redacted portions of this exhibit have been filed separately with
the Securities and Exchange Commission.
Item 16. Form 10-K Summary
The Company has elected not to include summary information.
150
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its
behalf by the undersigned, thereunto duly authorized.
KALEIDO BIOSCIENCES, INC.
By:
/s/ Daniel L. Menichella
Daniel L. Menichella
Chief Executive Officer, President and Director
We, the undersigned directors and officers of Kaleido Biosciences, Inc., hereby severally constitute and appoint Daniel L. Menichella and William Duke,
Jr., and each of them singly, our true and lawful attorneys, with full power to them, and to each of them singly, to sign for us and in our names in the
capacities indicated below, any and all amendments to this Annual Report on Form 10-K, and to file or cause to be filed the same, with all exhibits thereto
and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys, and each of them, full power
and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes
as each of us might or could do in person, and hereby ratifying and confirming all that said attorneys, and each of them, or their substitute or substitutes,
shall do or cause to be done by virtue of this Power of Attorney.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant
and in the capacities and on the dates indicated.
Name
Title
Date
/s/ Daniel L. Menichella
Daniel L. Menichella
Chief Executive Officer, President and Director
(Principal Executive Officer)
March 31, 2022
/s/ William Duke, Jr.
William Duke, Jr.
Chief Financial Officer
(Principal Financial and Accounting Officer)
March 31, 2022
/s/ Theo Melas-Kyriazi
Theo Melas-Kyriazi
Chair
March 31, 2022
/s/ Bonnie Bassler
Bonnie Bassler, Ph.D.
Director
March 31, 2022
/s/ Jean Mixer
Jean Mixer
Director
March 31, 2022
/s/ Anthony G. Quinn
Anthony G. Quinn, M.D., Ph.D.
Director
March 31, 2022
/s/ Anne Prener
Anne Prener, M.D., Ph.D.
Director
March 31, 2022
151
EXHIBIT 10.16
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED
BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY
DISCLOSED.
Execution Version
FOURTH AMENDMENT TO LOAN AND SECURITY AGREEMENT
THIS FOURTH AMENDMENT TO LOAN AND SECURITY AGREEMENT (this “Amendment”),
dated as of March 25, 2022 (the “Amendment Effective Date”), is made among Kaleido Biosciences, Inc., a Delaware corporation, and each of its
Qualified Subsidiaries (including Cadena Bio, Inc., a Delaware corporation) (collectively, jointly and severally, “Borrower”), the several banks and
other financial institutions or entities from time to time parties to the Loan Agreement (as defined below) (collectively, the “Lenders”) and
Hercules Capital, Inc., a Maryland corporation, in its capacity as administrative agent and collateral agent for itself and the Lenders (in such
capacity, “Agent”).
Borrower, the Lenders and Agent are parties to that certain Loan and Security Agreement, dated as of December 31, 2019, as amended by
that certain First Amendment to Loan and Security Agreement, dated as of April 10, 2020, that certain Second Amendment to Loan and Security
Agreement, dated as of June 15, 2020 and that certain Third Amendment to Loan and Security Agreement, dated as of April 30, 2021 (the
“Existing Loan Agreement”; and the Existing Loan Agreement, as amended by this Amendment and as further amended, restated, supplemented
or otherwise modified from time to time, the “Loan Agreement”). Borrower has requested that Agent and the Lenders agree to certain amendments
to the Existing Loan Agreement and consent to its making a partial prepayment of the outstanding Tranche 1 Advance in a principal amount of
$15,000,000. Agent and the Lenders have agreed to such request, subject to the terms and conditions hereof (and notwithstanding the provisions of
Section 2.5 of the Existing Loan Agreement in respect of Borrower’s request to make a partial prepayment).
Accordingly, the parties hereto agree as follows:
SECTION 1 Definitions; Interpretation.
(a)
Terms Defined in Loan Agreement. All capitalized terms used in this Amendment (including in the recitals hereof) and not
otherwise defined herein shall have the meanings assigned to them in the Loan Agreement.
(b)
Rules of Construction. The rules of construction that appear in the last paragraph of Section 1.3 of the Loan Agreement shall
be applicable to this Amendment and are incorporated herein by this reference.
SECTION 2 Amendments to the Loan Agreement.
(a)
Upon satisfaction of the conditions set forth in Section 3 hereof, the Existing Loan Agreement is hereby amended as follows:
(i)
Exhibit A attached hereto sets forth a clean copy of the Loan Agreement as amended
hereby;
(ii)
In Exhibit B hereto, deletions of the text in the Existing Loan Agreement (including, to the extent included
in such Exhibit B, each Schedule or Exhibit to the Existing Loan Agreement) are indicated by struck- through text, and insertions of text are
indicated by bold, double-underlined text.
1
US-DOCS\130693051.4
(b)
References Within Existing Loan Agreement. Each reference in the Existing Loan Agreement to “this Agreement” and the
words “hereof,” “herein,” “hereunder,” or words of like import, shall mean and be a reference to the Existing Loan Agreement as amended by this
Amendment.
SECTION 3 Conditions of Effectiveness. The effectiveness of Section 2 of this Amendment shall be subject to the satisfaction of each of the
following conditions precedent:
(a)
Fees and Expenses. Borrower shall have paid Agent (i) all reasonable invoiced costs and expenses then due in accordance with
Section 5(e), and (ii) all other reasonable invoiced fees, costs and expenses, if any, due and payable as of the Amendment Effective Date under the
Loan Agreement.
(b)
This Amendment. Agent shall have received this Amendment, executed by Borrower.
(c)
Borrower shall have prepaid a portion of the outstanding Tranche 1 Advance in a principal amount of $15,000,000 on the
Amendment Effective Date.
(d)
Representations and Warranties; No Default. On the Amendment Effective Date, after giving effect to the amendment of the
Loan Agreement contemplated hereby:
(i)
The representations and warranties contained in Section 4 shall be true and correct on and as of the
Amendment Effective Date as though made on and as of such date; and
(ii)
There exist no Events of Default or events that with the passage of time would result in an
Event of Default.
SECTION 4 Representations and Warranties. To induce Agent and the Lenders to enter into this Amendment, Borrower hereby confirms, as of
the date hereof, (a) that the representations and warranties made by it in Section 5 of the Loan Agreement and in the other Loan Documents are true
and correct in all material respects; provided, however, that such materiality qualifier shall not be applicable to any representations and warranties
that already are qualified or modified by materiality in the text thereof; provided, further, that to the extent such representations and warranties by
their terms expressly relate only to a prior date such representations and warranties shall be true and correct in all material respects as of such prior
date, and that no Event of Default has occurred and is continuing; (b) Agent has and shall continue to have valid, enforceable and perfected first-
priority liens, subject only to Permitted Liens, on and security interests in the Collateral and all other collateral heretofore granted by Borrower to
Agent, pursuant to the Loan Documents or otherwise granted to or held by Agent; (c) the agreements and obligations of Borrower contained in the
Loan Documents and in this Amendment constitute the legal, valid and binding obligations of Borrower, enforceable against Borrower in
accordance with their respective terms, except as the enforceability thereof may be limited by bankruptcy, insolvency or other similar laws of
general application affecting the enforcement of creditors’ rights or by the application of general principles of equity; and (d) the execution,
delivery and performance of this Amendment by Borrower will not violate any law, rule, regulation, order, contractual obligation or organizational
document of Borrower and will not result in, or require, the creation or imposition of any lien, claim or encumbrance of any kind on any of its
properties or revenues. For the purposes of this Section 4, each reference in Section 5 of the Loan Agreement to “this Agreement,” and the words
“hereof,” “herein,” “hereunder,” or words of like import in such Section, shall mean and be a reference to the Existing Loan Agreement as amended
by this Amendment.
SECTION 5 Miscellaneous.
(a)
Loan Documents Otherwise Not Affected; Reaffirmation; No Novation.
(i)
Except as expressly amended pursuant hereto or referenced herein, the Loan Agreement and the other Loan
Documents shall remain unchanged and in full force and effect and are hereby ratified and confirmed in all respects. The Lenders’ and Agent’s
execution and delivery of, or acceptance of, this Amendment shall not be deemed to create a course of dealing or otherwise create any express or
implied duty by any of them to provide any other or further amendments, consents or waivers in the future.
2
US-DOCS\130693051.4
(ii)
Borrower hereby expressly (1) reaffirms, ratifies and confirms its Secured Obligations under the Loan
Agreement and the other Loan Documents, (2) reaffirms, ratifies and confirms the grant of security under Section 3.1 of the Loan Agreement, (3)
reaffirms that such grant of security in the Collateral secures all Secured Obligations under the Loan Agreement, and with effect from (and
including) the date hereof, such grant of security in the Collateral: (x) remains in full force and effect notwithstanding the amendments expressly
referenced herein; and
(y)secures all Secured Obligations under the Existing Loan Agreement, as amended by this Amendment, and the other Loan Documents, (4) agrees
that this Amendment shall be a “Loan Document” under the Loan Agreement and
(5)agrees that the Loan Agreement and each other Loan Document shall remain in full force and effect following any action contemplated in
connection herewith.
(iii)
This Amendment is not a novation and the terms and conditions of this Amendment shall be in addition to
and supplemental to all terms and conditions set forth in the Loan Documents. Nothing in this Amendment is intended, or shall be construed, to
constitute an accord and satisfaction of Borrower’s Secured
Obligations under or in connection with the Loan Agreement and any other Loan Document or to modify, affect or impair the perfection or
continuity of Agent’s security interest in, (on behalf of itself and the Lenders) security titles to or other liens on any Collateral for the Secured
Obligations.
(a)
Conditions. For purposes of determining compliance with the conditions specified in Section 3, each Lender that has signed
this Amendment shall be deemed to have consented to, approved or accepted or to be satisfied with, each document or other matter required
thereunder to be consented to or approved by or acceptable or satisfactory to a Lender unless Agent shall have received notice from such Lender
prior to the date hereof specifying its objection thereto.
(b)
Release. In consideration of the agreements of Agent and each Lender contained herein and for other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, each Borrower, on behalf of itself and its successors, assigns, and
other legal representatives, hereby fully, absolutely, unconditionally and irrevocably releases, remises and forever discharges Agent and each
Lender, and its successors and assigns, and its present and former shareholders, affiliates, subsidiaries, divisions, predecessors, directors, officers,
attorneys, employees, agents and other representatives (Agent, the Lenders and all such other persons being hereinafter referred to collectively as
the “Releasees” and individually as a “Releasee”), of and from all demands, actions, causes of action, suits, covenants, contracts, controversies,
agreements, promises, sums of money, accounts, bills, reckonings, damages and any and all other claims, counterclaims, defenses, rights of set-off,
demands and liabilities whatsoever of every name and nature, known or unknown, suspected or unsuspected, both at law and in equity, which any
Borrower, or any of its successors, assigns, or other legal representatives may now or hereafter own, hold, have or claim to have against the
Releasees or any of them for, upon, or by reason of any circumstance, action, cause or thing whatsoever which arises at any time on or prior to the
day and date of this Amendment, including, without limitation, for or on account of, or in relation to, or in any way in connection with the Loan
Agreement, or any of the other Loan Documents or transactions thereunder or related thereto.
Each Borrower understands, acknowledges and agrees that the release set forth above may be pleaded as a full and complete defense and
may be used as a basis for an injunction against any action, suit or other proceeding which may be instituted, prosecuted or attempted in breach of
the provisions of such release. Each Borrower agrees that no fact, event, circumstance, evidence or transaction which could now be asserted or
which may hereafter be discovered shall affect in any manner the final, absolute and unconditional nature of the release set forth above. Each
Borrower waives the provisions of California Civil Code Section 1542, which states:
A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS THAT THE CREDITOR OR RELEASING PARTY DOES NOT KNOW
OR SUSPECT TO EXIST IN HIS OR HER FAVOR AT THE TIME OF EXECUTING THE RELEASE AND THAT, IF KNOWN BY HIM OR
HER, WOULD HAVE MATERIALLY AFFECTED HIS OR HER SETTLEMENT WITH THE DEBTOR OR RELEASED PARTY.
The provisions of this section shall survive payment in full of the Secured Obligations, full performance of all the terms of this
Amendment and the other Loan Documents.
3
US-DOCS\130693051.4
(c)
No Reliance. Each Borrower hereby acknowledges and confirms to Agent and the Lenders that such Borrower is executing this
Amendment on the basis of its own investigation and for its own reasons without reliance upon any agreement, representation, understanding or
communication by or on behalf of any other Person.
(d)
Costs and Expenses. Each Borrower agrees to pay to Agent the date hereof the reasonable invoiced out-of-pocket costs and
expenses of Agent and each Lender party hereto, and the reasonable invoiced out-of-pocket fees and disbursements of counsel to Agent and each
Lender party hereto (including allocated costs of internal counsel), in connection with the negotiation, preparation, execution and delivery of this
Amendment and any other documents to be delivered in connection herewith on the date hereof.
(e)
Binding Effect. This Amendment binds and is for the benefit of the successors and permitted assigns of each party.
(f)
Governing Law. This Amendment and the other Loan Documents shall be governed by, and construed and enforced in
accordance with, the laws of the State of California, excluding conflict of laws principles that would cause the application of laws of any other
jurisdiction.
(g)
Complete Agreement; Amendments. This Amendment and the Loan Documents represent the entire agreement about this
subject matter and supersede prior negotiations or agreements with respect to such subject matter. All prior agreements, understandings,
representations, warranties, and negotiations between the parties about the subject matter of this Amendment and the Loan Documents merge into
this Amendment and the Loan Documents.
(h)
Severability of Provisions. Each provision of this Amendment is severable from every other provision in determining the
enforceability of any provision.
(i)
Counterparts. This Amendment may be executed in any number of counterparts and by different parties on separate
counterparts, each of which, when executed and delivered, is an original, and all taken together, constitute one Amendment. Delivery of an
executed counterpart of a signature page of this Amendment by facsimile, portable document format (.pdf) or other electronic transmission will be
as effective as delivery of a manually executed counterpart hereof.
(j)
Loan Documents. This Amendment and the documents related thereto shall constitute Loan Documents.
(k)
Electronic Execution of Certain Other Documents. The words “execution,” “execute”, “signed,” “signature,” and words of
like import in or related to any document to be signed in connection with this Agreement and the transactions contemplated hereby (including
without limitation assignments, assumptions, amendments, waivers and consents) shall be deemed to include electronic signatures, the electronic
matching of assignment terms and contract formations on electronic platforms approved by Agent, or the keeping of records in electronic form,
each of which shall be of the same legal effect, validity or enforceability as a manually executed signature or the use of a paper-based
recordkeeping system, as the case may be, to the extent and as provided for in any applicable law, including the Federal Electronic Signatures in
Global and National Commerce Act, the California Uniform Electronic Transaction Act, or any other similar state laws based on the Uniform
Electronic Transactions Act.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
4
US-DOCS\130693051.4
IN WITNESS WHEREOF, the parties hereto have duly executed this Amendment, as of the date first above
written.
BORROWER:
KALEIDO BIOSCIENCES, INC.
Signature:
US-DOCS\130693051.4
[Signature Page to Fourth Amendment to Loan and Security Agreement]
Print Name: Title:
US-DOCS\130693051.4
[Signature Page to Fourth Amendment to Loan and Security Agreement]
Dan Menichella
Chief Executive Officer
US-DOCS\130693051.4
[Signature Page to Fourth Amendment to Loan and Security Agreement]
CADENA BIO, INC.
Signature:
US-DOCS\130693051.4
[Signature Page to Fourth Amendment to Loan and Security Agreement]
Print Name: Title:
US-DOCS\130693051.4
[Signature Page to Fourth Amendment to Loan and Security Agreement]
Dan Menichella
Chief Executive Officer
US-DOCS\130693051.4
[Signature Page to Fourth Amendment to Loan and Security Agreement]
[SIGNATURES CONTINUE ON THE NEXT PAGE]
US-DOCS\130693051.4
[Signature Page to Fourth Amendment to Loan and Security Agreement]
AGENT:
HERCULES CAPITAL, INC.
Signature:
Print Name:
Jennifer Choe
Title:
Associate General Counsel
LENDER:
HERCULES CAPITAL, INC.
Signature:
Print Name:
Jennifer Choe
Title:
Associate General Counsel HERCULES FUNDING
IV LLC
Signature:
Print Name:
Jennifer Choe
Title:
Associate General Counsel
US-DOCS\130693051.4
[Signature Page to Fourth Amendment to Loan and Security Agreement]
ANNEX A
(See Attached)
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693051.4
Conformed Through: 1st Amendment (4/10/20); 2nd Amendment (6/15/20); 3rd Amendment (4/30/21);
4th Amendment (3/25/22)
LOAN AND SECURITY AGREEMENT
THIS LOAN AND SECURITY AGREEMENT is made and dated as of December 31, 2019 and is entered into by and
among KALEIDO BIOSCIENCES, INC., a Delaware corporation (“Kaleido”), and each of its Qualified Subsidiaries (including
Cadena Bio, Inc., a Delaware corporation) (hereinafter collectively referred to as the “Borrower”), the several banks and other
financial institutions or entities from time to time parties to this Agreement (collectively, referred to as the “Lenders”) and
HERCULES CAPITAL, INC., a Maryland corporation, in its capacity as administrative agent and collateral agent for itself and the
Lenders (in such capacity, the “Agent”).
RECITALS
A.
Borrower has requested the Lenders make available to Borrower a loan in an aggregate principal amount of up to
Forty-One Million Seven Hundred Thousand Dollars ($41,700,000.00) (the “Term Loan”); and
B.
The Lenders are willing to make the Term Loan on the terms and conditions set forth in this Agreement.
AGREEMENT
NOW, THEREFORE, Borrower, Agent and the Lenders agree as follows:
SECTION 1. DEFINITIONS AND RULES OF CONSTRUCTION
1.1
Unless otherwise defined herein, the following capitalized terms shall have the following meanings:
“Account Control Agreement(s)” means any agreement entered into by and among the Agent, Borrower and a
third party bank or other institution (including a Securities Intermediary) in which Borrower maintains a Deposit Account or an
account holding Investment Property and which perfects Agent’s first priority security interest in the subject account or accounts.
“ACH Authorization” means the ACH Debit Authorization Agreement in substantially the form of Exhibit G,
which account numbers shall be redacted for security purposes if and when filed publicly by the Borrower.
“Advance(s)” means a Term Loan Advance.
“Advance Date” means the funding date of any Advance.
“Advance Request” means a request for an Advance submitted by Borrower to Agent in substantially the form of
Exhibit A, which account numbers shall be redacted for security purposes if and when filed publicly by the Borrower.
“Affiliate” means (a) any Person that directly or indirectly controls, is controlled by, or is under common control
with the Person in question, (b) any Person directly or indirectly owning, controlling or holding with power to vote ten percent (10%)
or more of the outstanding voting securities
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
of another Person, (c) any Person ten percent (10%) or more of whose outstanding voting securities are directly or indirectly owned,
controlled or held by another Person with power to vote such securities, or (d)
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
any Person related by blood or marriage to any Person described in subsection (a), (b) or (c) of this paragraph. As used in the
definition of “Affiliate,” the term “control” means the possession, directly or indirectly, of the power to direct or cause the direction of
the management and policies of a Person, whether through ownership of voting securities, by contract or otherwise.
“Agreement” means this Loan and Security Agreement, as amended from time to time. “Amortization Date” means
April 1, 2023.
“Anti-Corruption Laws” means all laws, rules, and regulations of any jurisdiction applicable to Borrower or
any of its Affiliates from time to time concerning or relating to bribery or corruption, including without limitation the United
States Foreign Corrupt Practices Act of 1977, as amended, the UK Bribery Act 2010 and other similar legislation in any other
jurisdictions.
“Anti-Terrorism Laws” means any laws, rules, regulations or orders relating to terrorism or money laundering,
including without limitation Executive Order No. 13224 (effective September 24, 2001), the USA PATRIOT Act, the laws comprising
or implementing the Bank Secrecy Act, and the laws administered by OFAC.
“Blocked Person” means any Person: (a) listed in the annex to, or is otherwise subject to the provisions of,
Executive Order No. 13224, (b) a Person owned or controlled by, or acting for or on behalf of, any Person that is listed in the annex
to, or is otherwise subject to the provisions of, Executive Order No. 13224, (c) a Person with which any Lender is prohibited from
dealing or otherwise engaging in any transaction by any Anti-Terrorism Law, (d) a Person that commits, threatens or conspires to
commit or supports “terrorism” as defined in Executive Order No. 13224, or (e) a Person that is named a “specially designated
national” or “blocked person” on the most current list published by OFAC or other similar list.
“Borrower Products” means all products, software, service offerings, technical data or technology currently being
designed, manufactured or sold by Borrower or which Borrower intends to sell, license, or distribute in the future including any
products or service offerings under development, collectively, together with all products, software, service offerings, technical data or
technology that have been sold, licensed or distributed by Borrower since its incorporation.
“Borrower’s Books” means Borrower’s or any of its Subsidiaries’ books and records including ledgers,
federal, state, local and foreign tax returns, records regarding Borrower’s or its Subsidiaries’ assets or liabilities, the Collateral,
business operations or financial condition, and all computer programs or storage or any equipment containing such information.
“Business Day” means any day other than Saturday, Sunday and any other day on which banking institutions in the State
of California are closed for business.
“CARES Act” means the Coronavirus Aid, Relief and Economic Stability Act. “Cash” means all cash,
cash equivalents and liquid funds.
“CFC” means a “controlled foreign corporation” as defined in Section 957 of the Code.
“CFC Holdco” means a direct or indirect Subsidiary of the Borrower substantially all of the assets of which are
Equity Interests (or Equity Interests and debt interests) in one or more CFCs.
US-DOCS\130693051.4
2
“Change in Control” means any reorganization, recapitalization, consolidation or merger (or similar transaction or
series of related transactions) of Borrower, sale or exchange of outstanding shares (or similar transaction or series of related
transactions) of Borrower in which the holders of Borrower’s outstanding shares immediately before consummation of such
transaction or series of related transactions do not, immediately after consummation of such transaction or series of related
transactions, retain shares representing more than fifty percent (50%) of the voting power of the surviving entity of such transaction
or series of related transactions (or the parent of such surviving entity if such surviving entity is wholly owned by such parent), in
each case without regard to whether Borrower is the surviving entity; provided, however, that an initial public offering shall not
constitute a Change in Control.
“Closing Date” means the date of this Agreement.
“Code” means the Internal Revenue Code of 1986, as amended.
“Contingent Obligation” means, as applied to any Person, any direct or indirect liability, contingent or otherwise,
of that Person with respect to (i) any Indebtedness, lease, dividend, letter of credit or other obligation of another, including any such
obligation directly or indirectly guaranteed, endorsed, co-made or discounted or sold with recourse by that Person, or in respect of
which that Person is otherwise directly or indirectly liable; (ii) any obligations with respect to undrawn letters of credit, corporate
credit cards or merchant services issued for the account of that Person; and (iii) all obligations arising under any interest rate,
currency or commodity swap agreement, interest rate cap agreement, interest rate collar agreement, or other agreement or
arrangement designated to protect a Person against fluctuation in interest rates, currency exchange rates or commodity prices;
provided, however, that the term “Contingent Obligation” shall not include endorsements for collection or deposit in the ordinary
course of business.
The amount of any Contingent Obligation shall be deemed to be an amount equal to the stated or determined amount of the primary
obligation in respect of which such Contingent Obligation is made or, if not stated or determinable, the maximum reasonably
anticipated liability in respect thereof as determined by such Person in good faith; provided, however, that such amount shall not in
any event exceed the maximum amount of the obligations under the guarantee or other support arrangement.
“Copyright License” means any written agreement granting any right to use any Copyright or Copyright
registration, now owned or hereafter acquired by Borrower or in which Borrower now holds or hereafter acquires any interest.
“Copyrights” means all copyrights, whether registered or unregistered, held pursuant to the laws of the United
States of America, any State thereof, or of any other country.
“Deposit Accounts” means any “deposit accounts,” as such term is defined in the UCC, and includes any
checking account, savings account, or certificate of deposit that is not evidenced by an instrument.
“Designated Account” means the account number ending [***] (last three digits), maintained by Borrower with
JPMorgan Chase Bank, N.A., or any other account that Borrower designates from time to time to Agent in writing with reasonable
notice.
“Domestic Subsidiary” means any Subsidiary organized under the laws of the United States of America, any State
thereof, the District of Columbia, or any other jurisdiction within the United States of America.
US-DOCS\130693051.4
3
“Due Diligence Fee” means $20,000, which fee has been paid to the Lenders prior to the Closing Date, and shall
be deemed fully earned on such date regardless of the early termination of this Agreement.
“Eligible Foreign Subsidiary” means each Foreign Subsidiary other than an Excluded
Subsidiary.
“Equity Interests” means, with respect to any Person, the capital stock, partnership or limited liability company
interest, or other equity securities or equity ownership interests of such Person.
“Equity Milestone” means satisfaction of each of the following events: (a) no Event of Default shall have
occurred and be continuing; and (b) Kaleido has received unrestricted (including, not subject to any redemption, clawback, escrow or
similar encumbrance or restriction) net Cash proceeds of at least $15,000,000 raised from one or more bona fide equity financings,
and/or Subordinated Indebtedness in each case, after the Fourth Amendment Effective Date and subject to verification by Agent
(including supporting documentation reasonably requested by Agent), but excluding any Cash proceeds from the Loan.
“ERISA” means the Employee Retirement Income Security Act of 1974, as amended, and the regulations
promulgated thereunder.
“Excluded Subsidiary” means (x) each direct and indirect Subsidiary of the Borrower (a) that is a CFC, (b) that is a
direct or indirect Subsidiary of a CFC, or (c) that is a CFC Holdco; in each case, provided that (i) the pledge of all or substantially all
of the Equity Interests of such Subsidiary as Collateral,
(ii) the guarantee by such Subsidiary of the Secured Obligations, or (iii) the execution of a Joinder Agreement by such Subsidiary,
would result in material adverse tax consequences to the Borrower (as reasonably determined by the Borrower and Agent) and (y) the
MSC Subsidiary.
“First Amendment” means that certain First Amendment to Loan and Security Agreement, dated as of the First
Amendment Date, by and among Borrower, the Lenders and Agent.
“First Amendment Date” means April 10, 2020.
“Foreign Subsidiary” means any Subsidiary other than a Domestic Subsidiary. “Fourth Amendment
Effective Date” means March 25, 2022.
“GAAP” means generally accepted accounting principles in the United States of America, as in effect
from time to time.
“Human Clinical Trial” means any clinical program, tested in humans, that has received permission by the United
States Food and Drug Administration under an Investigational New Drug pathway.
“Human Study” means a clinical program, tested in humans, that has not received permission by the United States
Food and Drug Administration under an Investigational New Drug pathway but instead follows the pathway for food development.
“Indebtedness” means indebtedness of any kind, including (a) all indebtedness for
US-DOCS\130693051.4
4
borrowed money or the deferred purchase price of property or services (excluding trade credit entered into in the ordinary course of
business due within ninety (90) days), including reimbursement and other
US-DOCS\130693051.4
5
obligations with respect to surety bonds and letters of credit, (b) all obligations evidenced by notes, bonds, debentures or similar
instruments, (c) all capital lease obligations, (d) non-contingent obligations to reimburse any bank or Person in respect of amounts
paid under a letter of credit, banker’s acceptance or similar instrument, (e) equity securities of any Person subject to repurchase or
redemption other than at the sole option of such Person, other than any such equity securities that are subject to repurchase or
redemption solely after the 91st day after the Term Loan Maturity Date, (f) earn outs, purchase price adjustments, deferred purchase
amounts and similar payment obligations or any nature arising out of purchase and sale contracts, and (g) all Contingent Obligations.
“Initial Facility Charge” means One Hundred Thirty-Seven Thousand Five Hundred Dollars ($137,500), which is
payable to the Lenders in accordance with Section 4.1(f).
“Insolvency Proceeding” means any proceeding by or against any Person under the United States Bankruptcy
Code, or any other bankruptcy or insolvency law, including assignments for the benefit of creditors, compositions, extensions
generally with its creditors, or proceedings seeking reorganization, arrangement, or other similar relief.
“Intellectual Property” means all of Borrower’s Copyrights; Trademarks; Patents; Licenses; trade secrets and
inventions; mask works; Borrower’s applications therefor and reissues, extensions, or renewals thereof; and Borrower’s goodwill
associated with any of the foregoing, together with Borrower’s rights to sue for past, present and future infringement of Intellectual
Property and the goodwill associated therewith.
“Investment” means any beneficial ownership (including stock, partnership, limited liability company interests, or
other securities) of or in any Person, or any loan, advance or capital contribution to any Person or the acquisition of any material asset
or property of another Person.
“IRS” means the United States Internal Revenue Service.
“Joinder Agreements” means for each Subsidiary (other than an Excluded Subsidiary), a completed and executed Joinder
Agreement in substantially the form attached hereto as Exhibit F.
“License” means any Copyright License, Patent License, Trademark License or other license of rights or interests.
“Lien” means any mortgage, deed of trust, pledge, hypothecation, assignment for security, security interest,
encumbrance, levy, lien or charge of any kind, whether voluntarily incurred or arising by operation of law or otherwise, against any
property, any conditional sale or other title retention agreement, and any lease in the nature of a security interest.
“Loan” means the Advances made under this Agreement.
“Loan Documents” means this Agreement, the promissory notes (if any), the ACH Authorization, the Account
Control Agreements, the Joinder Agreements, all UCC Financing Statements, the Pledge Agreement, and any other documents
executed in connection with the Secured Obligations or the transactions contemplated hereby, as the same may from time to time be
amended, modified, supplemented or restated.
“Material Adverse Effect” means a material adverse effect upon: (i) the business, operations, properties, assets or
financial condition of Borrower and its Subsidiaries taken as a whole; or
US-DOCS\130693051.4
6
(ii) the ability of Borrower to perform or pay the Secured Obligations in accordance with the terms of the
US-DOCS\130693051.4
7
Loan Documents, or the ability of Agent or the Lenders to enforce any of its rights or remedies with respect to the Secured
Obligations; or (iii) the Collateral or Agent’s Liens on the Collateral or the priority of such Liens (other than as a result of a failure by
the Agent to make any necessary filings or maintain possession of any possessory collateral).
“Maximum Term Loan Amount” means Forty-One Million Seven Hundred Thousand and No/100 Dollars
($41,700,000.00).
“MSC Investment Conditions” means that Borrower maintains Qualified Cash in an amount equal to or greater
than the lesser of (i) 110% of the aggregate outstanding Secured Obligations (inclusive of any Prepayment Charge and End of Term
Charge that would be due and owing if the outstanding Loans were prepaid at the time of measurement) plus the Qualified Cash A/P
Amount or (ii) 100% of the consolidated Cash of Borrower and its Subsidiaries, unless compliance with the foregoing conditions are
waived in writing from time to time by Agent with respect to specified periods, in Agent’s sole discretion.
“MSC Subsidiary” means Kaleido Biosciences Securities Corporation, a wholly-owned Subsidiary incorporated
in the Commonwealth of Massachusetts or the State of Delaware for the purpose of holding Investments as a Massachusetts security
corporation under 830 CMR 63.38B.1 of the Massachusetts tax code and applicable regulations (as the same may be amended,
modified or replaced from time to time).
“Non-Core Intellectual Property” means microbiome metabolic therapy candidates that do not target, directly,
indirectly, entirely or partially, any of the following indications: urea cycle disorders, hepatic encephalopathy, multi drug resistant
infection, COVID-19, chronic kidney disease, atherosclerotic cardiovascular disease, cardio-metabolic syndrome, immuno-oncology,
Inflammatory Bowel Disease or any indication related to the KB195, KB174, KB109, or KB295 programs, and in each case any
related programs or related Intellectual Property in connection with such indications.
“Non-Consenting Lender” means any Lender that does not approve any consent, waiver or amendment that (a)
requires the approval of all or all affected Lenders in accordance with the terms of Section 11.3 and (b) has been approved by the
Required Lenders.
“Non-Disclosure Agreement” means that certain Non-Disclosure Agreement by and between Kaleido Biosciences,
Inc. and Hercules Capital, Inc. dated as of October 2, 2019.
“OFAC” is the U.S. Department of Treasury Office of Foreign Assets Control.
“OFAC Lists” are, collectively, the Specially Designated Nationals and Blocked Persons List maintained by OFAC
pursuant to Executive Order No. 13224, 66 Fed. Reg. 49079 (Sept. 25, 2001) and/or any other list of terrorists or other restricted
Persons maintained pursuant to any of the rules and regulations of OFAC or pursuant to any other applicable Executive Orders.
“Patent License” means any written agreement granting any right with respect to any invention on which a Patent
is in existence or a Patent application is pending, in which agreement Borrower now holds or hereafter acquires any interest.
“Patents” means all letters patent of, or rights corresponding thereto, in the United States of America or in any
other country, all registrations and recordings thereof, and all applications for letters patent of, or rights corresponding thereto, in the
United States of America or any other country.
US-DOCS\130693051.4
8
“Performance Milestone I” means satisfaction of each of the following events:
(a) [***]; and
(b)
[***],
“Performance Milestone II” means satisfaction of each of the following events:
(a)
[***];
(b)
[***]; and
(c) On or prior to February 28, 2021, Borrower has either:
(i)
[***]; or
(ii)
[***].
“Performance Milestone III” means satisfaction of each of the following events:
US-DOCS\130693051.4
9
(a)
[***];
(b)
[***]; and
(c)
[***].
“Permitted In-Licenses” means (a) any License with respect to which Borrower is the licensee, in which: (i)
Borrower and its Subsidiaries are not reasonably likely to be required to transfer cash or other consideration, prior to the Term Loan
Maturity Date, assets or property valued (book or market) at more than $1,000,000 in the aggregate for all such Licenses and (ii) is
not a Restricted License.
“Permitted Indebtedness” means:
(i)
Indebtedness of Borrower in favor of the Lenders or Agent arising under this Agreement or
any other Loan Document;
(ii)
Indebtedness existing on the Closing Date which is disclosed in Schedule 1A;
(iii)
Indebtedness of up to $250,000 outstanding at any time secured by a Lien described in clause
(vii) of the defined term “Permitted Liens,” provided such Indebtedness does not exceed the cost of the Equipment
financed with such Indebtedness;
(iv)
without duplication of any other item of Permitted Indebtedness, Indebtedness to trade
creditors incurred in the ordinary course of business (due within 90 days), including such Indebtedness incurred in the
ordinary course of business with corporate credit cards in an amount to not exceed $500,000 outstanding at any time;
(v)
Indebtedness that also constitutes a Permitted Investment;
(vi)
Subordinated Indebtedness;
(vii)
without duplication of any other item of Permitted Indebtedness, reimbursement obligations in
connection with letters of credit that are secured by Cash and issued on behalf of the Borrower or a Subsidiary thereof in an
amount not to exceed $2,500,000 at any time outstanding,
US-DOCS\130693051.4
10
(viii)
Indebtedness consisting of a loan under the Paycheck Protection Program of the CARES Act
provided that (i) such loan shall be unsecured and shall not contain any terms or conditions that are adverse to Agent’s and
the Lenders’ rights under this Agreement, including with respect to collateral, priority, preference and repayment terms and
(ii) any material modification to such loan shall be subject to Agent’s written approval (a “PPP Loan”),
(ix)
other unsecured Indebtedness in an amount not to exceed $250,000 at any time outstanding,
(x)
intercompany Indebtedness as long as either (A) each of the Subsidiary obligor and the
Subsidiary obligee under such Indebtedness is a Borrower or Domestic Subsidiary that has executed a Joinder Agreement or
(B) each of the obligor and obligee are Foreign Subsidiaries;
(xi)
Indebtedness consisting of interest rate, currency, or commodity swap agreements, interest rate
cap or collar agreements or arrangements entered into in the ordinary course of business and designated to protect
Borrower or its Subsidiaries against fluctuations in interest rates, currency exchange rates, or commodity prices as long as
the aggregate outstanding nominal value outstanding of such Indebtedness does not exceed $500,000;
(xii)
Indebtedness consisting of financing of insurance premiums in the ordinary course of
business;
(xiii)
to the extent constituting Indebtedness obligations, Indebtedness in respect of netting services
or overdraft protection or otherwise in connection with deposit or securities accounts in the ordinary course of business;
and
(xiv)
extensions, refinancings and renewals of any items of Permitted Indebtedness, provided that
the principal amount is not increased or the terms modified to impose materially more burdensome terms upon Borrower
or its Subsidiary, as the case may be.
“Permitted Investment” means:
(i)
Investments existing on the Closing Date which are disclosed in Schedule 1B;
(ii)
short-term, customary, non-speculative money market securities pursuant to Borrower’s
investment policy provided to Agent on the Closing Date;
(iii)
(a) marketable direct obligations issued or unconditionally guaranteed by the United States of
America or any agency or any State thereof maturing within one year from the date of acquisition thereof currently having a
rating of at least A-2 or P-2 from either Standard & Poor’s Corporation or Moody’s Investors Services, (b) commercial
paper maturing no more than one year from the date of creation thereof and currently having a rating of at least A-2 or P-2
from either Standard & Poor’s Corporation or Moody’s Investors Service, (c) certificates of deposit issued by any bank
with assets of at least $500,000,000 maturing no more than one year from the date of investment therein, and (d) money
market accounts;
(iv)
repurchases of stock from former or existing employees, directors, or consultants of Borrower
under the terms of applicable repurchase agreements in an aggregate amount not to exceed $250,000 in any fiscal year,
provided that no Event of Default has occurred, is continuing or would exist after giving effect to the repurchases;
US-DOCS\130693051.4
11
(v)
Investments accepted in connection with Permitted Transfers;
(vi)
Investments (including debt obligations) received in connection with the bankruptcy or
reorganization of customers or suppliers and in settlement of delinquent obligations of, and other disputes with, customers
or suppliers arising in the ordinary course of Borrower’s business;
(vii)
Investments consisting of notes receivable of, or prepaid royalties and other credit extensions,
to customers and suppliers who are not Affiliates, in the ordinary course of business, provided that this subparagraph (vii)
shall not apply to Investments of Borrower in any Subsidiary;
(viii)
Investments consisting of loans not involving the net transfer on a substantially
contemporaneous basis of cash proceeds to employees, officers or directors relating to the purchase of capital stock of
Borrower pursuant to employee stock purchase plans or other similar agreements approved by Borrower’s Board of
Directors;
(ix)
Investments consisting of (a) travel advances, employee relocation loans and other employee
loans in the ordinary course of business and (b) loans to employees, officers or directors relating to the purchase of equity
securities of Borrower or its Subsidiaries pursuant to employee stock purchase plans or agreements;
(x)
Investments in newly-formed Domestic Subsidiaries, provided that each such Domestic
Subsidiary has entered into or enters into a Joinder Agreement promptly after its formation by Borrower and execute such
other documents as shall be reasonably requested by Agent;
(xi)
Investments in Foreign Subsidiaries approved in advance in writing by Agent;
(xii)
joint ventures, research collaborations or strategic alliances in the ordinary course of
Borrower’s business including any licensing of Non-Core Intellectual Property permitted hereunder, nonexclusive
licensing of technology, the development of technology or the providing of technical support, provided that any cash
Investments by Borrower do not exceed
$1,000,000 in the aggregate in any fiscal year and $2,000,000 in the aggregate during the term of this Agreement;
(xiii)
subject to Section 7.12, Investments in Deposit Accounts;
(xiv)
Investments in the MSC Subsidiary, so long as an Event of Default does not exist at the time of
such Investment and would not exist after giving effect to such Investment and provided that Borrower is, at all times, in
compliance with the MSC Investment Conditions; and
(xv)additional Investments that do not exceed $250,000 in the aggregate. “Permitted Liens”
means:
(i)
Liens in favor of Agent or the Lenders;
(ii)
Liens existing on the Closing Date which are disclosed in Schedule 1C;
US-DOCS\130693051.4
12
(iii)
Liens for taxes, fees, assessments or other governmental charges or levies, either not delinquent
or being contested in good faith by appropriate proceedings diligently conducted; provided, that Borrower maintains
adequate reserves therefor on Borrower’s Books in accordance with GAAP;
(iv)
Liens securing claims or demands of materialmen, artisans, mechanics, carriers, warehousemen,
landlords and other like Persons arising in the ordinary course of Borrower’s business and imposed without action of such
parties; provided, that the payment thereof is not yet required;
(v)
Liens arising from judgments, decrees or attachments in circumstances which do not
constitute an Event of Default hereunder;
(vi)
the following deposits, to the extent made in the ordinary course of business: deposits under
worker’s compensation, unemployment insurance, social security and other similar laws, or to secure the performance of
bids, tenders or contracts (other than for the repayment of borrowed money) or to secure indemnity, performance or other
similar bonds for the performance of bids, tenders or contracts (other than for the repayment of borrowed money) or to
secure statutory obligations (other than Liens arising under ERISA or environmental Liens) or surety or appeal bonds, or to
secure indemnity, performance or other similar bonds;
(vii)
Liens on Equipment or software or other intellectual property constituting purchase money Liens
and Liens in connection with capital leases securing Indebtedness permitted in clause (iii) of “Permitted Indebtedness”;
(viii)
Liens incurred in connection with Subordinated Indebtedness;
(ix)
leasehold interests in leases or subleases and licenses granted in the ordinary course of
business and not interfering in any material respect with the business of the licensor;
(x)
Liens in favor of customs and revenue authorities arising as a matter of law to secure payment
of custom duties that are promptly paid on or before the date they become due;
(xi)
Liens on insurance proceeds securing the payment of financed insurance premiums that are
promptly paid on or before the date they become due (provided that such Liens extend only to such insurance proceeds and
not to any other property or assets);
(xii)
statutory and common law rights of set-off and other similar rights as to deposits of cash
and securities in favor of banks, other depository institutions and brokerage firms;
(xiii)
easements, zoning restrictions, rights-of-way and similar encumbrances on real property
imposed by law or arising in the ordinary course of business so long as they do not materially impair the value or
marketability of the related property;
(xiv)
(A) Liens on Cash securing obligations permitted under clause (vii) of the definition of
Permitted Indebtedness and (B) security deposits in connection with real property leases, the combination of (A) and (B)
in an aggregate amount not to exceed $250,000 at any time; and
US-DOCS\130693051.4
13
(xv)
licenses permitted hereunder;
US-DOCS\130693051.4
14
(xvi)
Liens in favor of other financial institutions arising in connection with Deposit Accounts
and/or securities accounts held at such institutions in the ordinary course of business;
(xvii)
Liens consisting of pledges of cash, cash equivalents or government securities to secure swap or
foreign exchange contracts or letters of credit, in a combined aggregate amount outstanding not to exceed $500,000;
(xviii)
the filing of UCC financing statements solely as a precautionary measure in connection with
operating leases or consignment of goods;
(xix)
Liens not otherwise permitted hereunder securing Indebtedness with specific assets in an
aggregate outstanding amount not to exceed $250,000; and
(xx)
Liens incurred in connection with the extension, renewal or refinancing of the Indebtedness
secured by Liens of the type described in clauses (i) through (xix) above; provided, that any extension, renewal or
replacement Lien shall be limited to the property encumbered by the existing Lien and the principal amount of the
Indebtedness being extended, renewed or refinanced (as may have been reduced by any payment thereon) does not increase.
“Permitted Out-Licenses” mean the following licenses entered into in the ordinary course
of business:
(i)
non-exclusive licenses and non-exclusive arrangements for the use of Intellectual Property;
(ii)
licenses that could not result in a legal transfer of title of the licensed property that may be exclusive in
respects other than territory; and
(iii)
licenses that could not result in a legal transfer of title of the licensed property that may be exclusive as to
territory:
(x) but only as to discreet geographical areas outside of the United States of America, or
(y) solely for Non-Core Intellectual Property. “Permitted Transfers”
means:
(i)
sales of Inventory in the ordinary course of business,
(ii)
Permitted Out-Licenses,
(iii)
dispositions of worn-out, obsolete or surplus Equipment at fair market value in the ordinary
course of business,
(iv)
(iv) the sale or issuance of any stock of Borrower not prohibited under this
Agreement,
(v)
Borrower’s use or transfer of cash in a manner that is not prohibited by the terms of this
Agreement or the other Loan Documents; and
US-DOCS\130693051.4
15
(vi)
other transfers of assets having a fair market value of not more than $250,000 in the aggregate
in any fiscal year.
“Person” means any individual, sole proprietorship, partnership, joint venture, trust, unincorporated organization,
association, corporation, limited liability company, institution, other entity or government.
“Pledge Agreement” means the Pledge Agreement dated as of the Closing Date between Borrower and Agent, as the
same may from time to time be amended, restated, modified or otherwise supplemented.
“Qualified Cash” means the amount of Borrower’s Cash held in accounts in the United States subject to an
Account Control Agreement in favor of Agent.
“Qualified Cash A/P Amount” means the amount of Borrower’s and its Subsidiaries’ accounts payable that
have not been paid within ninety (90) days from the invoice date of the relevant account payable.
“Qualified Subsidiary” means any direct or indirect Subsidiary other than an Excluded
Subsidiary.
“Receivables” means (i) all of Borrower’s Accounts, Instruments, Documents, Chattel Paper, Supporting
Obligations, letters of credit, proceeds of any letter of credit, and Letter of Credit Rights, and (ii) all customer lists, software, and
business records related thereto.
“Required Lenders” means at any time, the holders of more than 50% of the sum of the aggregate unpaid
principal amount of the Term Loans then outstanding.
“Restricted License” means any material License or other agreement with respect to which Borrower is the
licensee (a) that prohibits or otherwise restricts Borrower from granting a security interest in Borrower’s interest in such License or
agreement or any other property, or (b) for which a default under or termination of could interfere with the Agent’s right to sell any
Collateral.
“Sanctioned Country” means, at any time, a country or territory which is the subject or target of any Sanctions.
“Sanctioned Person” means, at any time, (a) any Person listed in any Sanctions-related list of designated Persons
maintained by the Office of Foreign Assets Control of the U.S. Department of the Treasury or the U.S. Department of State, or by the
United Nations Security Council, the European Union or any EU member state, (b) any Person operating, organized or resident in a
Sanctioned Country or (c) any Person controlled by any such Person.
“Sanctions” means economic or financial sanctions or trade embargoes imposed, administered or enforced from
time to time by (a) the U.S. government, including those administered by the Office of Foreign Assets Control of the U.S.
Department of the Treasury or the U.S. Department of State, or (b) the United Nations Security Council, the European Union or
Her Majesty’s Treasury of the United Kingdom.
“Second Amendment Effective Date” means June 15, 2020.
US-DOCS\130693051.4
16
“Second Interest Only Extension Conditions” shall mean satisfaction of each of the following events: (a) no default
or Event of Default shall have occurred, and (b) Borrower achieves Performance Milestone II, subject to verification by Agent
(including supporting documentation requested by Agent).
“Secured Obligations” means Borrower’s obligations under this Agreement and any Loan Document, including any
obligation to pay any amount now owing or later arising.
“Subordinated Indebtedness” means Indebtedness subordinated to the Secured Obligations in amounts and on terms
and conditions satisfactory to Agent in its sole discretion and subject to a subordination agreement in form and substance satisfactory
to Agent in its sole discretion.
“Subsequent Financing” means the closing of any Borrower financing which becomes effective after the Closing
Date.
“Subsequent Financing Securities” means, with respect to any Subsequent Financing, the class and series of
common stock, convertible preferred stock or other equity security of Borrower (or instruments exercisable for or convertible into
shares of common stock, convertible preferred stock or other equity securities) sold and issued by Borrower to the investor purchasers
in such Subsequent Financing.
“Subsidiary” means an entity, whether a corporation, partnership, limited liability company, joint venture or
otherwise, in which Borrower owns or controls 50% or more of the outstanding voting securities, including each entity listed on
Schedule 1 hereto.
“Taxes” means all present or future taxes, levies, imposts, duties, deductions, withholdings (including backup
withholding), assessments, fees or other charges imposed by any governmental authority, including any interest, additions to tax or
penalties applicable thereto.
“Term Commitment” means as to any Lender, the obligation of such Lender, if any, to make a Term Loan
Advance to the Borrower in a principal amount not to exceed the amount set forth under the heading “Term Commitment”
opposite such Lender’s name on Schedule 1.1.
“Term Loan Advance” means each Tranche 1 Advance, Tranche 2 Advance, Tranche 3 Advance, Tranche 4 Advance
and any other Term Loan funds advanced under this Agreement.
“Term Loan Interest Rate” means, for any day a per annum rate of interest equal to the greater of either (i) 9.35%
plus the prime rate as reported in The Wall Street Journal minus 3.25%, and (ii) 9.35%.
“Term Loan Maturity Date” means January 1, 2024; provided that if such day is not a Business Day, the Term
Loan Maturity Date shall be the immediately preceding Business Day.
“Third Amendment Effective Date” means April 30, 2021.
“Trademark License” means any written agreement granting any right to use any Trademark or Trademark
registration, now owned or hereafter acquired by Borrower or in which Borrower now holds or hereafter acquires any interest.
“Trademarks” means all trademarks (registered, common law or otherwise) and any
US-DOCS\130693051.4
17
applications in connection therewith, including registrations, recordings and applications in the United
US-DOCS\130693051.4
18
States Patent and Trademark Office or in any similar office or agency of the United States of America, any State thereof or any other
country or any political subdivision thereof.
“Tranche 3 Facility Charge” means half of one percent (0.50%) of the Tranche 3 Advance, which is payable to
Lender in accordance with Section 4.2(d).
“UCC” means the Uniform Commercial Code as the same is, from time to time, in effect in the State of California;
provided, that in the event that, by reason of mandatory provisions of law, any or all of the attachment, perfection or priority of, or
remedies with respect to, Agent’s Lien on any Collateral is governed by the Uniform Commercial Code as the same is, from time to
time, in effect in a jurisdiction other than the State of California, then the term “UCC” shall mean the Uniform Commercial Code as
in effect, from time to time, in such other jurisdiction solely for purposes of the provisions thereof relating to such attachment,
perfection, priority or remedies and for purposes of definitions related to such provisions.
“U.S. Person” means any Person that is a “United States person” as defined in Section 7701(a)(30) of the Code.
1.2
The following terms are defined in the Sections or subsections referenced opposite such
terms:
Defined Term
Section
Agent
Preamble
Assignee
11.14
Borrower
Preamble
Claims
11.11
Collateral
3.1
Confidential Information
11.13
End of Term Charge
2.6
Event of Default
9
Financial Statements
7.1
Hercules Purchaser
8.1
Indemnified Person
6.3
Lenders
Preamble
Liabilities
6.3
Maximum Rate
2.3
Open Source License
5.10
Participant Register
11.8
Prepayment Charge
2.5
Publicity Materials
11.19
Register
11.7
Rights to Payment
3.1
Tranche 1 Advance
2.2(a)
Tranche 2 Advance
2.2(a)
Tranche 3 Advance
2.2(a)
Tranche 4 Advance
2.2(a)
US-DOCS\130693051.4
19
1.3
Unless otherwise specified, all references in this Agreement or any Annex or Schedule hereto to a “Section,”
“subsection,” “Exhibit,” “Annex,” or “Schedule” shall refer to the corresponding Section, subsection, Exhibit, Annex, or Schedule in
or to this Agreement. Unless otherwise specifically provided herein, any accounting term used in this Agreement or the other Loan
Documents shall have the meaning customarily given such term in accordance with GAAP, and all financial computations hereunder
shall be computed in accordance with GAAP, consistently applied. Unless otherwise defined herein or in the other Loan Documents,
terms that are used herein or in the other Loan Documents and defined in the UCC shall have the meanings given to them in the UCC.
For all purposes under the Loan Documents, in connection with any division or plan of division under Delaware law (or any
comparable event under a different jurisdiction’s laws): (a) if any asset, right, obligation or liability of any Person becomes the asset,
right, obligation or liability of a different Person, then it shall be deemed to have been transferred from the original Person to the
subsequent Person and (b) if any new Person comes into existence, such new Person shall be deemed to have been organized on the
first date of its existence by the holders of its Equity Interests at such time.
SECTION 2. THE LOAN
1.1
[Reserved.]
1.2
Term Loan.
(a)
Advances. Subject to the terms and conditions of this Agreement, the Lenders will severally (and not
jointly) make in an amount not to exceed its respective Term Commitment, and Borrower agrees to draw, a Term Loan
Advance of Twenty-Two Million Five Hundred Thousand Dollars ($22,500,000) on the Closing Date (the “Tranche 1
Advance”). Subject to the terms and conditions of this Agreement, beginning on the Third Amendment Effective Date and
continuing through June 1, 2021, Borrower may request, and the Lenders shall severally (and not jointly) make, an
additional Term Loan Advance in a principal amount of Five Million Dollars ($5,000,000) (the “Tranche 2 Advance”).
Subject to the terms and conditions of this Agreement, and conditioned on approval by the Lenders’ investment committee
in its sole and unfettered discretion, on or before December 15, 2021, Borrower may request an additional Term Loan
Advance in a principal amount up to Twelve Million Five Hundred Thousand Dollars ($12,500,000) (the “Tranche 3
Advance”). Subject to the terms and conditions of this Agreement, beginning on the date Borrower achieves the Equity
Milestone and continuing through July 31, 2022, Borrower may request and the Lenders shall severally (and not jointly)
make an additional Term Loan Advance in a principal amount One Million Seven Hundred Thousand Dollars ($1,700,000)
(the “Tranche 4 Advance”). The aggregate outstanding Term Loan Advances may be up to the Maximum Term Loan
Amount. For clarity, as of the Fourth Amendment Effective Date, neither the Tranche 2 Advance nor the Tranche 3 Advance
has been funded and is available.
(b)
Advance Request. To obtain a Term Loan Advance, Borrower shall complete, sign and deliver an
Advance Request (at least three (3) Business Days before the Advance Date other than the Closing Date, which shall be at
least one (1) Business Day) to Agent. The Lenders shall fund the Term Loan Advance in the manner requested by the
Advance Request provided that each of the conditions precedent set forth in Section 4 and applicable to such Term Loan
Advance is satisfied as of the requested Advance Date.
(c)
Interest. Term Loan Interest Rate. The principal balance shall bear interest thereon from such
Advance Date at the Term Loan Interest Rate based on a year consisting
US-DOCS\130693051.4
20
of
US-DOCS\130693051.4
21
360 days, with interest computed daily based on the actual number of days elapsed. The Term Loan Interest Rate will float
and change on the day the prime rate changes from time to time.
(d)
Payment. Borrower will pay interest on each Term Loan Advance in arrears on the first Business Day of
each month, beginning the month after the Advance Date. Borrower shall repay the aggregate Term Loan principal balance
that is outstanding on the day immediately preceding the Amortization Date, in equal monthly installments of principal and
interest (mortgage style) beginning on the Amortization Date and continuing on the first Business Day of each month
thereafter until the Secured Obligations (other than inchoate indemnity obligations) are repaid. The entire Term Loan
principal balance and all accrued but unpaid interest hereunder, shall be due and payable on the Term Loan Maturity Date.
Borrower shall make all payments under this Agreement without setoff, recoupment or deduction and regardless of any
counterclaim or defense. If a payment hereunder becomes due and payable on a day that is not a Business Day, the due date
thereof shall be the immediately following Business Day. The Lenders will initiate debit entries to the Borrower’s
Designated Account or any other account as authorized on the ACH Authorization (i) on each payment date of all periodic
obligations payable to the Lenders under each Term Loan Advance and (ii) reasonable and documented out-of-pocket legal
fees and costs incurred by Agent or the Lenders in connection with Section 11.12 of this Agreement; provided that, with
respect to clause (i) above, in the event that the Lenders or Agent informs Borrower that the Lenders will not initiate a debit
entry to Borrower’s account for a certain amount of the periodic obligations due on a specific payment date, Borrower shall
pay to the Lenders such amount of periodic obligations in full in immediately available funds on such payment date;
provided, further, that, with respect to clause (i) above, if the Lenders or Agent informs Borrower that the Lenders will not
initiate a debit entry as described above later than the date that is three (3) Business Days prior to such payment date,
Borrower shall pay to the Lenders such amount of periodic obligations in full in immediately available funds on the date that
is three
(3) Business Days after the date on which the Lenders or Agent notifies Borrower of such; provided, further, that, with
respect to clause (ii) above, in the event that the Lenders or Agent informs Borrower that the Lenders will not initiate a debit
entry to Borrower’s account for certain amount of such out-of-pocket legal fees and costs incurred by Agent or the Lenders,
Borrower shall pay to the Lenders such amount in full in immediately available funds within three (3) Business Days.
1.4
Maximum Interest. Notwithstanding any provision in this Agreement or any other Loan Document, it is the
parties’ intent not to contract for, charge or receive interest at a rate that is greater than the maximum rate permissible by law
that a court of competent jurisdiction shall deem applicable hereto (which under the laws of the State of California shall be
deemed to be the laws relating to permissible rates of interest on commercial loans) (the “Maximum Rate”). If a court of
competent jurisdiction shall finally determine that Borrower has actually paid to the Lenders an amount of interest in excess
of the amount that would have been payable if all of the Secured Obligations had at all times borne interest at the Maximum
Rate, then such excess interest actually paid by Borrower shall be applied as follows: first, to the payment of the Secured
Obligations consisting of the outstanding principal; second, after all principal is repaid, to the payment of the Lenders’
accrued interest, reasonable and documented out-of-pocket costs, expenses, professional fees and any other Secured
Obligations; and third, after all Secured Obligations are repaid, the excess (if any) shall be refunded to Borrower.
1.5
Default Interest. In the event any payment is not paid on the scheduled payment date, an amount equal to
five percent (5%) of the past due amount shall be payable on demand. In addition, upon the occurrence and during the
continuation of an Event of Default hereunder,
US-DOCS\130693051.4
22
all
US-DOCS\130693051.4
23
outstanding Secured Obligations, including principal, interest, compounded interest, and professional fees, shall bear interest
at a rate per annum equal to the rate set forth in Section 2.2(c), plus five percent (5%) per annum. In the event any interest is
not paid when due hereunder, delinquent interest shall be added to principal and shall bear interest on interest, compounded at
the rate set forth in Section 2.2(c) or Section 2.4, as applicable.
1.5
Prepayment. At its option upon at least five (5) Business Days prior written notice to Agent, Borrower may
prepay all, but not less than all, of the outstanding Advances by paying the entire principal balance, all accrued and unpaid
interest thereon, together with a prepayment charge equal to the following percentage of the Advance amount being prepaid:
with respect to each Advance, if such Advance amounts are prepaid in any of the first twelve (12) months following the
Closing Date, 2.00%; after twelve (12) months but on or prior to twenty four (24) months, 1.50%; after twenty four (24)
months but on or prior to thirty six (36) months, 1.00%; and thereafter, 0.00% (each, a “Prepayment Charge”). Borrower
agrees that the Prepayment Charge is a reasonable calculation of the Lenders’ lost profits in view of the difficulties and
impracticality of determining actual damages resulting from an early repayment of the Advances. Borrower shall prepay the
outstanding amount of all principal and accrued interest through the prepayment date and the applicable Prepayment Charge
upon the occurrence of a Change in Control or any other prepayment hereunder. Notwithstanding the foregoing, Agent and
the Lenders agree to waive the Prepayment Charge (i) if Agent and the Lenders (in their sole and absolute discretion) agree in
writing to refinance the Advances prior to the Term Loan Maturity Date or (ii) otherwise applicable to that portion of the
outstanding Tranche 1 Advance prepaid in a principal amount of $15,000,000 on the Fourth Amendment Effective Date. Any
amounts paid under this Section shall be applied by Agent to the then unpaid amount of any Secured Obligations (including
principal and interest) in such order and priority as Agent may choose in its sole discretion. For the avoidance of doubt, if a
payment hereunder becomes due and payable on a day that is not a Business Day, the due date thereof shall be the
immediately following Business Day.
1.6
End of Term Charge. On the earliest to occur of (i) the Term Loan Maturity Date,
(ii) the date that Borrower prepays the outstanding Secured Obligations (other than any inchoate indemnity obligations and
any other obligations which, by their terms, are to survive the termination of this Agreement) in full, or (iii) the date that the
Secured Obligations become due and payable, Borrower shall pay the Lenders a charge of $1,698,750 (the “End of Term
Charge”). Notwithstanding the required payment date of such End of Term Charge, the applicable pro rata portion of the End
of Term Charge shall be deemed earned by the Lenders as of each date a Term Loan Advance is made. For the avoidance of
doubt, if a payment hereunder becomes due and payable on a day that is not a Business Day, the due date thereof shall be the
immediately following Business Day.
1.7
Pro Rata Treatment. Each payment (including prepayment) on account of any fee and any reduction of the
Term Loan Advances shall be made pro rata according to the Term Commitments of the relevant Lender.
1.8
Taxes; Increased Costs. The Borrower, the Agent and the Lenders each hereby agree to the terms and
conditions set forth on Addendum 1 attached hereto.
1.9
Treatment of Prepayment Charge and End of Term Charge. Borrower agrees that any Prepayment Charge
and any End of Term Charge payable shall be presumed to be the liquidated damages sustained by each Lender as the result
of the early termination, and Borrower agrees that it is reasonable under the circumstances currently existing and existing as
of the
US-DOCS\130693051.4
24
Closing Date. The Prepayment Charge and the End of Term Charge shall also be payable in the event the Secured Obligations
(and/or this Agreement) are satisfied or released by foreclosure (whether by power of judicial proceeding), deed in lieu of
foreclosure, or by any other means. Borrower expressly waives (to the fullest extent it may lawfully do so) the provisions of
any present or future statute or law that prohibits or may prohibit the collection of the foregoing Prepayment Charge and End
of Term Charge in connection with any such acceleration. Borrower agrees (to the fullest extent that each may lawfully do
so): (a) each of the Prepayment Charge and the End of Term Charge is reasonable and is the product of an arm’s length
transaction between sophisticated business people, ably represented by counsel; (b) each of the Prepayment Charge and the
End of Term Charge shall be payable notwithstanding the then prevailing market rates at the time payment is made; (c) there
has been a course of conduct between the Lenders and Borrower giving specific consideration in this transaction for such
agreement to pay the Prepayment Charge and the End of Term Charge as a charge (and not interest) in the event of
prepayment or acceleration; (d) Borrower shall be estopped from claiming differently than as agreed to in this Section 2.9.
Borrower expressly acknowledges that their agreement to pay each of the Prepayment Charge and the End of Term Charge to
the Lenders as herein described was on the Closing Date and continues to be a material inducement to the Lenders to provide
the Term Loans.
SECTION 3. SECURITY INTEREST
1.1
As security for the prompt and complete payment when due (whether on the payment dates or otherwise) of
all the Secured Obligations, subject to Section 3.2, Borrower grants to Agent a security interest in all of Borrower’s right,
title, and interest in and to the following Borrower’s personal property whether now owned or hereafter acquired (collectively,
the “Collateral”): (a) Receivables; (b) Equipment; (c) Fixtures; (d) General Intangibles (other than Intellectual Property); (e)
Inventory; (f) Investment Property; (g) Deposit Accounts; (h) Cash; (i) Goods; and all other tangible and intangible personal
property of Borrower whether now or hereafter owned or existing, leased, consigned by or to, or acquired by, Borrower and
wherever located, and any of Borrower’s property in the possession or under the control of Agent; and, to the extent not
otherwise included, all Proceeds of each of the foregoing and all accessions to, substitutions and replacements for, and rents,
profits and products of each of the foregoing; provided, however, that the Collateral shall include all Accounts and General
Intangibles that consist of rights to payment and proceeds from the sale, licensing or disposition of all or any part, or rights in,
the Intellectual Property (the “Rights to Payment”). Notwithstanding the foregoing, if a judicial authority (including a U.S.
Bankruptcy Court) holds that a security interest in the underlying Intellectual Property is necessary to have a security interest
in the Rights to Payment, then the Collateral shall automatically, and effective as of the date of this Agreement, include the
Intellectual Property to the extent necessary to permit perfection of Agent’s security interest in the Rights to Payment.
1.2
Notwithstanding the broad grant of the security interest set forth in Section 3.1, above, the Collateral shall
not include (a) nonassignable licenses or contracts, which by their terms require the consent of the licensor thereof or another
party (but only to the extent such prohibition on transfer is enforceable under applicable law, including, without limitation,
Sections 9406, 9407 and 9408 of the UCC), (b) any Intellectual Property, (c) assets as to which a security interest in such
assets is prohibited by applicable law, rule or regulation (but only to the extent and during such times such prohibition exists),
(d) more than 65% of the presently existing and hereafter arising issued and outstanding Equity Interests owned by Borrower
of any Excluded Subsidiary that is a CFC or CFC Holdco which Equity Interests entitle the holder thereof to vote for
directors or any other matter (provided, however, that in the case of this clause (d),
US-DOCS\130693051.4
25
immediately upon any
US-DOCS\130693051.4
26
change in the U.S. tax laws that would allow the pledge of a greater percentage of such Equity Interests without material
adverse tax consequences to the Borrower, the Collateral shall automatically and without further action required by, and
without notice to, any Person include such greater percentage of Equity Interests of such Subsidiary from that time forward)
and (e) the assets of any (i) Excluded Subsidiary or (ii) MSC Subsidiary, in each case, including the Equity Interests of any
Subsidiary thereof.
1.3
The security interest granted in Section 3.1 of this Agreement shall continue until the Secured Obligations
(other than contingent indemnification or reimbursement obligations that are not yet due and payable) have been paid in full
and Lender has no further commitment or obligation hereunder or under the other Loan Documents to make any further
Advances, and shall thereupon terminate, and Lender shall, at Borrower’s expense, take all actions reasonably requested by
Borrower to evidence such termination.
SECTION 4. CONDITIONS PRECEDENT TO LOAN
The obligations of the Lenders to make the Loan hereunder are subject to the satisfaction by Borrower of the
following conditions:
1.1
Initial Advance. On or prior to the Closing Date, Borrower shall have delivered to Agent the following:
(a)
executed copies of the Loan Documents, Account Control Agreements, and all other documents and
instruments reasonably required by Agent to effectuate the transactions contemplated hereby or to create and perfect the
Liens of Agent with respect to all Collateral, in all cases in form and substance reasonably acceptable to Agent;
(b)
a legal opinion of Borrower’s counsel, in form and substance reasonably acceptable to Agent;
(c)
certified copy of resolutions of Borrower’s board of directors evidencing approval of the Loan
and other transactions evidenced by the Loan Documents;
(d)
certified copies of the Certificate of Incorporation and the Bylaws, as amended through the Closing
Date, of Borrower;
(e)
a certificate of good standing for Borrower from its state of incorporation and similar certificates from
all other jurisdictions in which it does business and where the failure to be qualified would have a Material Adverse
Effect;
(f)
payment of the Initial Facility Charge and reimbursement of Agent’s and Lenders’ current expenses
reimbursable pursuant to this Agreement and which have been invoiced to Borrower prior to the date hereof, which
amounts may be deducted from the initial Advance;
(g)
all certificates of insurance and copies of each insurance policy required hereunder; and
(h)
such other documents as Agent may reasonably request.
US-DOCS\130693051.4
27
1.2
All Advances. On each Advance Date:
US-DOCS\130693051.4
28
(a)
Agent shall have received (i) an Advance Request for the relevant Advance as required by Section
2.2(b), each duly executed by Borrower’s Chief Executive Officer or Chief Financial Officer, and (ii) any other
documents Agent may reasonably request.
(b)
The representations and warranties set forth in this Agreement shall be true and correct in all material
respects on and as of the Advance Date with the same effect as though made on and as of such date, except to the extent
such representations and warranties expressly relate to an earlier date, in which case such representations and warranties
shall have been true and correct in all material respects as of such date.
(c)
Borrower shall be in compliance with all the terms and provisions set forth herein and in each other Loan
Document on its part to be observed or performed, and at the time of and immediately after such Advance no Event of
Default shall have occurred and be continuing.
(d)
With respect to the Tranche 3 Advance, Borrower shall have paid the Tranche 3 Facility Charge;
(e)
Each Advance Request shall be deemed to constitute a representation and warranty by Borrower on the
relevant Advance Date as to the matters specified in paragraphs (b) and (c) of this Section 4.2 and as to the matters set forth
in the Advance Request.
1.4
No Default. As of the Closing Date and each Advance Date, (i) no fact or condition exists that would
(or would, with the passage of time, the giving of notice, or both) constitute an Event of Default and (ii) no event that has
had or could reasonably be expected to have a Material Adverse Effect has occurred and is continuing.
SECTION 5. REPRESENTATIONS AND WARRANTIES OF BORROWER
Borrower represents and warrants that:
1.1
Corporate Status. Borrower is a corporation duly organized, legally existing and in good standing under the
laws of the State of Delaware, and is duly qualified as a foreign corporation in all jurisdictions in which the nature of its
business or location of its properties require such qualifications and where the failure to be qualified could reasonably be
expected to have a Material Adverse Effect. Borrower’s present name, former names (if any), locations, place of formation,
tax identification number, organizational identification number and other information are correctly set forth in Exhibit B, as
may be updated by Borrower in a written notice (including any Compliance Certificate) provided to Agent after the Closing
Date.
1.2
Collateral. Borrower owns the Collateral and the Intellectual Property, free of all Liens, except for
Permitted Liens. Borrower has the power and authority to grant to Agent a Lien in the Collateral as security for the Secured
Obligations.
1.3
Consents. Borrower’s execution, delivery and performance of this Agreement and all other Loan
Documents (i) have been duly authorized by all necessary corporate action of Borrower, (ii) will not result in the creation or
imposition of any Lien upon the Collateral, other than Permitted Liens and the Liens created by this Agreement and the other
Loan Documents, (iii) do not violate any provisions of Borrower’s Certificate or Articles of Incorporation (as applicable),
bylaws, or any material law, regulation, order, injunction, judgment, decree or writ to
US-DOCS\130693051.4
29
which Borrower is subject and (iv) except as described on Schedule 5.3, do not violate in any material
US-DOCS\130693051.4
30
respect any material contract or agreement or require the consent or approval of any other Person which has not already
been obtained. The individual or individuals executing the Loan Documents are duly authorized to do so.
1.4
Material Adverse Effect. No event that has had or could reasonably be expected to have a Material
Adverse Effect has occurred and is continuing. Borrower is not aware of any event likely to occur that is reasonably
expected to result in a Material Adverse Effect.
1.5
Actions Before Governmental Authorities. There are no actions, suits or proceedings at law or in equity or
by or before any governmental authority now pending or, to the knowledge of Borrower, threatened in writing against or
affecting Borrower or its property, that is reasonably expected to result in a Material Adverse Effect.
1.6
Laws. Neither Borrower nor any of its Subsidiaries is in violation of any law, rule or regulation, or in
default with respect to any judgment, writ, injunction or decree of any governmental authority, where such violation or
default is reasonably expected to result in a Material Adverse Effect. Borrower is not in default in any manner under any
provision of any agreement or instrument evidencing material Indebtedness, or any other material agreement to which it is a
party or by which it is bound and for which such default would reasonably be expected to result in a Material Adverse Effect.
Neither Borrower nor any of its Subsidiaries is an “investment company” or a company “controlled” by an
“investment company” under the Investment Company Act of 1940, as amended. Neither Borrower nor any of its Subsidiaries
is engaged as one of its important activities in extending credit for margin stock (under Regulations X, T and U of the Federal
Reserve Board of Governors). Borrower and each of its Subsidiaries has complied in all material respects with the Federal Fair
Labor Standards Act. Neither Borrower nor any of its Subsidiaries is a “holding company” or an “affiliate” of a “holding
company” or a “subsidiary company” of a “holding company” as each term is defined and used in the Public Utility Holding
Company Act of 2005.
Neither Borrower’s nor any of its Subsidiaries’ properties or assets has been used by Borrower or such Subsidiary or, to
Borrower’s knowledge, by previous Persons, in disposing, producing, storing, treating, or transporting any hazardous
substance other than in material compliance with applicable laws. Borrower and each of its Subsidiaries has obtained all
consents, approvals and authorizations of, made all declarations or filings with, and given all notices to, all governmental
authorities that are necessary to continue their respective businesses as currently conducted.
None of Borrower, any of its Subsidiaries, or any of Borrower’s or its Subsidiaries’ Affiliates or any of their
respective agents acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement is (i)
in violation of any Anti-Terrorism Law, (ii) engaging in or conspiring to engage in any transaction that evades or avoids, or has
the purpose of evading or avoiding or attempts to violate, any of the prohibitions set forth in any Anti-Terrorism Law, or (iii) is
a Blocked Person. None of Borrower, any of its Subsidiaries, or to the knowledge of Borrower and any of its Affiliates or
agents, acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement, (x) conducts
any business or engages in making or receiving any contribution of funds, goods or services to or for the benefit of any
Blocked Person, or (y) deals in, or otherwise engages in any transaction relating to, any property or interest in property blocked
pursuant to Executive Order No. 13224, any similar executive order or other Anti-Terrorism Law. None of the funds to be
provided under this Agreement will be used, directly or indirectly, (a) for any activities in violation of any applicable anti-
money laundering, economic sanctions and anti-bribery laws and regulations laws and regulations or (b) for any payment to
any
US-DOCS\130693051.4
31
governmental official or employee, political party, official of a political party, candidate for political office, or anyone
else acting in an official capacity, in order to obtain, retain or direct business or obtain any improper advantage, in
violation of the United States Foreign Corrupt Practices Act of 1977, as amended.
1.7
Information Correct and Current. No information, report, Advance Request, financial statement, exhibit or
schedule furnished, by or on behalf of Borrower to Agent in connection with any Loan Document or included therein or
delivered pursuant thereto (other than the projections) contained, or, when taken as a whole, contains or will contain any
material misstatement of fact or, when taken together with all other such information or documents, omitted, omits or will
omit to state any material fact necessary to make the statements therein, in the light of the circumstances under which they
were, are or will be made, not materially misleading at the time such statement was made or deemed made. Additionally, any
and all financial or business projections provided by Borrower to Agent, whether prior to or after the Closing Date, shall be
(i) provided in good faith and based on the most current data and information available to Borrower, and (ii) the most current
of such projections provided to Borrower’s Board of Directors (it being understood that such projections are subject to
significant uncertainties and contingencies, many of which are beyond the control of Borrower, that no assurance is given
that any particular projections will be realized and that actual results may differ materially).
1.8
Tax Matters. Except as described on Schedule 5.8, (a) Borrower and its Subsidiaries have filed all federal
and state income Tax returns and other material Tax returns that they are required to file, (b) Borrower and its Subsidiaries
have duly paid all federal and state income Taxes and other material Taxes or installments thereof (including any interest or
penalties) as and when due, except those being contested in good faith with adequate reserves taken in connection thereto in
accordance with GAAP, (c) Borrower has paid or fully reserved for any tax assessment received by Borrower for the three (3)
years preceding the Closing Date, if any, and (d) to Borrower’s knowledge, no proposed or pending Tax assessments,
deficiencies, audits or other proceedings with respect to Borrower or any Subsidiary have had, or could reasonably be
expected to have, individually or in the aggregate, a Material Adverse Effect.
1.9
Intellectual Property Claims. Borrower is the sole owner of, or otherwise has the right to use, the
Intellectual Property material to Borrower’s business. Except as described on Schedule 5.9, (i) each of the material
Copyrights, Trademarks and Patents is valid and enforceable,
(ii)no material part of the Intellectual Property has been judged invalid or unenforceable, in whole or in part, and (iii) to the
best of Borrower’s knowledge, no claim has been made in writing alleging to Borrower that any material part of the
Intellectual Property violates the rights of any third party. Exhibit C is a true, correct and complete list of each of Borrower’s
Patents, registered Trademarks, registered Copyrights, and material agreements under which Borrower licenses Intellectual
Property from third parties (other than shrink-wrap software licenses or other licenses which, if terminated, would not
reasonably be expected to result in a Material Adverse Effect), together with application or registration numbers, as
applicable, owned by Borrower or any Subsidiary, in each case as of the Closing Date. Borrower is not in material breach of,
nor has Borrower failed to perform any material obligations under, any of the foregoing contracts, licenses or agreements
and, to Borrower’s knowledge, no third party to any such contract, license or agreement is in material breach thereof or has
failed to perform any material obligations thereunder, except as would not reasonably be expected to result in a Material
Adverse Effect.
US-DOCS\130693051.4
32
1.10
Intellectual Property. To the best of Borrower’s knowledge, except as described on Schedule 5.10,
Borrower has all material rights with respect to Intellectual Property necessary or material in the operation or conduct of
Borrower’s business as currently conducted and proposed to be conducted by Borrower. Without limiting the generality of
the foregoing, and in the case of Licenses, except for restrictions that are unenforceable under Division 9 of the UCC,
Borrower has the right, to the extent required to operate Borrower’s business, to freely transfer, license or assign Intellectual
Property necessary or material in the operation or conduct of Borrower’s business as currently conducted and proposed to be
conducted by Borrower, without condition, restriction or payment of any kind (other than license payments in the ordinary
course of business) to any third party, and Borrower owns or has the right to use, pursuant to valid licenses, all software
development tools, library functions, compilers and all other third-party software and other items that are material to
Borrower’s business and used in the design, development, promotion, sale, license, manufacture, import, export, use or
distribution of Borrower Products except customary covenants in inbound license agreements and equipment leases where
Borrower is the licensee or lessee. Borrower is not a party to, nor is it bound by, any Restricted License.
No material software or other materials used by Borrower or any of its Subsidiaries (or used in any Borrower Products or any
Subsidiaries’ products) are subject to an open-source or similar license (including but not limited to the General Public
License, Lesser General Public License, Mozilla Public License, or Affero License) (collectively, “Open Source Licenses”) in
a manner that would cause such software or other materials to have to be (i) distributed to third parties at no charge or a
minimal charge (royalty-free basis); (ii) licensed to third parties to modify, make derivative works based on, decompile,
disassemble, or reverse engineer; or (iii) used in a manner that does could require disclosure or distribution in source code
form.
1.11
Borrower Products. Except as described on Schedule 5.11, no material Intellectual Property owned by
Borrower or Borrower Product has been or is subject to any actual or, to the knowledge of Borrower, threatened in writing
litigation, proceeding (including any proceeding in the United States Patent and Trademark Office or any corresponding
foreign office or agency) or outstanding decree, order, judgment, settlement agreement or stipulation that restricts in any
manner Borrower’s use, transfer or licensing thereof or that would reasonably be expected to adversely affect the validity, use
or enforceability thereof. There is no decree, order, judgment, agreement, stipulation, arbitral award or other provision
entered into in connection with any litigation or proceeding before a governmental authority that obligates Borrower to grant
licenses or ownership interest in any future Intellectual Property material to the operation or conduct of the business of
Borrower or Borrower Products. Borrower has not received any written notice or claim, or, to the knowledge of Borrower,
oral notice or claim, challenging or questioning Borrower’s ownership in any material Intellectual Property (or written notice
of any claim challenging or questioning the ownership in any material licensed Intellectual Property of the owner thereof) or
suggesting that any third party has any claim of legal or beneficial ownership with respect thereto nor, to Borrower’s
knowledge, is there a reasonable basis for any such claim. To the Borrower’s knowledge, neither Borrower’s use of its
material Intellectual Property nor the production and sale of Borrower Products infringes the material Intellectual Property or
other rights of others.
1.12
Financial Accounts. Exhibit D, as may be updated by the Borrower in a written notice provided to Agent
after the Closing Date, is a true, correct and complete list of (a) all banks and other financial institutions at which Borrower
or any Subsidiary maintains Deposit Accounts and (b) all institutions at which Borrower or any Subsidiary maintains an
account holding
US-DOCS\130693051.4
33
Investment Property, and such exhibit correctly identifies the name, address and telephone number of each bank or other
institution, the name in which the account is held, a description of the purpose of the account, and the complete account
number therefor.
1.13
Employee Loans. Borrower has no outstanding loans to any employee, officer or director of the Borrower
nor has Borrower guaranteed the payment of any loan made to an employee, officer or director of the Borrower by a third
party.
1.14
Capitalization and Subsidiaries. Borrower’s capitalization as of the Closing Date is set forth on Schedule
5.14 annexed hereto. Borrower does not own any stock, partnership interest or other securities of any Person, except for
Permitted Investments. Attached as Schedule 5.14, as may be updated by Borrower in a written notice provided after the
Closing Date, is a true, correct and complete list of each Subsidiary.
1.15
Certain Subsidiary Voting Rights. No decision or action in any governing document of any Excluded
Subsidiary that is a CFC or CFC Holdco requires a vote of greater than 50.1% of the Equity Interests or voting rights of such
Subsidiary, other than with Agent’s written consent.
SECTION 6. INSURANCE; INDEMNIFICATION
1.1
Coverage. Borrower shall cause to be carried and maintained commercial general liability insurance, on an
occurrence form, against risks customarily insured against by businesses of Borrower’s size in Borrower’s line of business in
similar locations. Such risks shall include the risks of bodily injury, including death, property damage, personal injury,
advertising injury, and contractual liability per the terms of the indemnification agreement found in Section 6.3. Borrower
must maintain a minimum of $2,000,000 of commercial general liability insurance for each occurrence. Borrower has and
agrees to maintain a minimum of $2,000,000 of directors’ and officers’ insurance for each occurrence and $5,000,000 in the
aggregate. So long as there are any Secured Obligations (other than inchoate indemnification or reimbursement obligations or
other obligations which, by their terms, survive termination of this Agreement) outstanding, Borrower shall also cause to be
carried and maintained insurance upon the Collateral, insuring against all
risks of physical loss or damage howsoever caused, in an amount not less than the full replacement cost of the Collateral,
provided that such insurance may be subject to standard exceptions and deductibles. If Borrower fails to obtain the insurance
called for by this Section 6.1 or fails to pay any premium thereon or fails to pay any other amount which Borrower is
obligated to pay under this Agreement or any other Loan Document or which may be required to preserve the Collateral,
Agent may obtain such insurance or make such payment, and all amounts so paid by Agent are immediately due and payable,
bearing interest at the then highest rate applicable to the Secured Obligations, and secured by the Collateral. Agent will make
reasonable efforts to provide Borrower with notice of Agent obtaining such insurance at the time it is obtained or within a
reasonable time thereafter. No payments by Agent are deemed an agreement to make similar payments in the future or
Agent’s waiver of any Event of Default.
1.2
Certificates. Borrower shall deliver to Agent certificates of insurance that evidence Borrower’s compliance
with its insurance obligations in Section 6.1 and the obligations contained in this Section 6.2. Borrower’s insurance certificate
shall state Agent (shown as “Hercules Capital, Inc., as Agent”) is an additional insured for commercial general liability, a
lenders loss payable for all risk property damage insurance, subject to the insurer’s approval, and a lenders loss payable for
property insurance and additional insured for liability insurance for any
US-DOCS\130693051.4
34
future insurance that Borrower may acquire from such insurer. Notwithstanding the foregoing, (i) so long as no Event of
Default has occurred and is continuing, Borrower shall have the option of applying the proceeds of any casualty policy up to
$250,000 in the aggregate for all losses under all casualty policies in any one (1) year, toward the replacement or repair of
destroyed or damaged property; provided that any such replaced or repaired property (A) shall be of equal or like value as the
replaced or repaired Collateral and (B) shall be deemed Collateral in which Agent has been granted a first priority security
interest (subject only to Permitted Liens that are permitted pursuant to the terms of this Agreement to have superior priority to
Agent’s Lien), and (ii) after the occurrence and during the continuance of an Event of Default, all proceeds payable under
such casualty policy shall, at the option of Agent, be payable to Agent on account of the Secured Obligations. Borrower shall
deliver additional insured endorsements for liability and lender’s loss payable endorsements for all risk property damage
insurance pursuant to Section 7.16(b). All certificates of insurance will provide for a minimum of thirty (30) days advance
written notice to Agent of cancellation (other than cancellation for non-payment of premiums, for which ten (10) days’
advance written notice shall be sufficient). Any failure of Agent to scrutinize such insurance certificates for compliance is not
a waiver of any of Agent’s rights, all of which are reserved.
Upon request by Agent, Borrower shall provide Agent with copies of each insurance policy, and upon entering or amending
any insurance policy required hereunder, Borrower shall provide Agent with copies of such policies and shall promptly
deliver to Agent updated insurance certificates with respect to such policies.
1.3
Indemnity. Borrower agrees to indemnify and hold Agent, the Lenders and their officers, directors,
employees, agents, in-house attorneys, representatives and shareholders (each, an “Indemnified Person”) harmless from and
against any and all claims, reasonable and documented out-of-pocket costs, expenses, damages and liabilities (including such
claims, costs, expenses, damages and liabilities based on liability in tort, including strict liability in tort), including reasonable
and documented out-of-pocket attorneys’ fees and disbursements and other costs of investigation or defense (including those
incurred upon any appeal) (collectively, “Liabilities”), that may be instituted or asserted against or incurred by such
Indemnified Person as the result of credit having been extended, suspended or terminated under this Agreement and the other
Loan Documents or the administration of such credit, or in connection with or arising out of the transactions contemplated
hereunder and thereunder, or any actions or failures to act in connection therewith, or arising out of the disposition or
utilization of the Collateral, excluding in all cases Liabilities to the extent resulting solely from any Indemnified Person’s
gross negligence or willful misconduct. This Section 6.3 shall not apply with respect to Taxes other than any Taxes that
represent losses, claims, damages, etc. arising from any non-Tax claim. In no event shall any Indemnified Person be liable on
any theory of liability for any special, indirect, consequential or punitive damages (including any loss of profits, business or
anticipated savings). This Section 6.3 shall survive the repayment of indebtedness under, and otherwise shall survive the
expiration or other termination of, the Loan Agreement.
SECTION 7. COVENANTS OF BORROWER
Borrower agrees as follows:
1.1
Financial Reports. Borrower shall furnish to Agent the financial statements and reports listed hereinafter
(the “Financial Statements”):
(a)
as soon as practicable (and in any event within 30 days) after the end of each month, unaudited
interim and year-to-date financial statements as of the end of such month
US-DOCS\130693051.4
35
(prepared on a consolidated and consolidating basis, if applicable), including balance sheet and related statements of income
and cash flows accompanied by a report detailing any material contingencies (including the commencement of any material
litigation by or against Borrower) or any other occurrence that could reasonably be expected to have a Material Adverse
Effect, all certified by Borrower’s Chief Executive Officer or Chief Financial Officer to the effect that they have been
prepared in accordance with GAAP, except (i) for the absence of footnotes, (ii) that they are subject to normal year end
adjustments, and (iii) they do not contain certain non-cash items that are customarily included in quarterly and annual
financial statements;
(b)
as soon as practicable (and in any event within 45 days) after the end of each calendar quarter, unaudited
interim and year-to-date financial statements as of the end of such calendar quarter (prepared on a consolidated and
consolidating basis, if applicable), including balance sheet and related statements of income and cash flows accompanied by
a report detailing any material contingencies (including the commencement of any material litigation by or against
Borrower) or any other occurrence that would reasonably be expected to have a Material Adverse Effect, certified by
Borrower’s Chief Executive Officer or Chief Financial Officer to the effect that they have been prepared in accordance with
GAAP, except (i) for the absence of footnotes, and (ii) that they are subject to normal year end adjustments.
(c)
as soon as practicable (and in any event within ninety (90) days) after the end of each fiscal year,
unqualified (other than as to going concern or a qualification resulting solely from the scheduled maturity of the Advances
occurring within one year from the date such opinion is delivered) audited financial statements as of the end of such year
(prepared on a consolidated and consolidating basis, if applicable), including balance sheet and related statements of
income and cash flows, and setting forth in comparative form the corresponding figures for the preceding fiscal year,
certified by a firm of independent certified public accountants selected by Borrower and reasonably acceptable to Agent,
accompanied by any management report from such accountants;
(d)
as soon as practicable (and in any event within 30 days) after the end of each month, a Compliance
Certificate in the form of Exhibit E;
(e)
as soon as practicable (and in any event within 30 days) after the end of each month, a report
showing agings of accounts receivable and accounts payable;
(f)
promptly after the sending or filing thereof, as the case may be, (i) copies of any proxy statements,
financial statements or reports that Borrower has made generally available to holders of its preferred stock and (ii) copies
of any regular, periodic and special reports or registration statements that Borrower files with the Securities and Exchange
Commission or any governmental authority that may be substituted therefor, or any national securities exchange;
(g)
within ten (10) Business Days after a Board meeting, an executive summary of the materials that
Borrower provides to its directors in connection with meetings of the Board of Directors, provided that in all cases
Borrower may exclude highly confidential information, information that would present a conflict of interest and information
subject to attorney-client privilege;
(h)
financial and business projections promptly following their approval by Borrower’s Board of
Directors, and in any event, within 60 days after the end of Borrower’s
US-DOCS\130693051.4
36
fiscal year, as well as budgets, operating plans and other financial information reasonably requested by Agent; and
(i)
immediate notice if Borrower or any Subsidiary has knowledge that Borrower, or any Subsidiary or
Affiliate of Borrower, is listed on the OFAC Lists or (a) is convicted on,
(b) pleads nolo contendere to, (c) is indicted on, or (d) is arraigned and held over on charges involving money
laundering or predicate crimes to money laundering.
Borrower shall not make any change in its (a) accounting policies or reporting practices, except as required by GAAP or (b)
fiscal years or fiscal quarters. The fiscal year of Borrower shall end on December 31.
The executed Compliance Certificate and all Financial Statements required to be delivered pursuant to clauses (a), (b), (c) and
(d) shall be sent via e-mail to Agent at financialstatements@htgc.com with a copy to legal@htgc.com and
jbourque@htgc.com; provided, that if e-mail is not available or sending such Financial Statements via e-mail is not possible,
they shall be faxed to Agent at: (650) 473-9194, attention Account Manager: Kaleido Biosciences, Inc.
Notwithstanding the foregoing, documents required to be delivered under Sections 7.1(a), (b), (c) or
(f) (to the extent any such documents are included in materials otherwise filed with the SEC) may be delivered electronically
and if so delivered, shall be deemed to have been delivered on the date on which Borrower posts such documents, or provides
a link thereto, on Borrower’s website on the Internet at Borrower’s website address; provided that Borrower shall directly
provide Agent all Financial Statements required to be delivered pursuant to Section 7.1(b) and (c) hereunder.
1.3
Management Rights. Borrower shall permit any representative that Agent or the Lenders authorizes,
including its attorneys and accountants, to inspect the Collateral and examine and make copies and abstracts of the books of
account and records of Borrower at reasonable times and upon reasonable notice during normal business hours; provided,
however, that so long as no Event of Default has occurred and is continuing, such examinations shall be limited to no more
often than once per fiscal year. In addition, in connection with any such examination, any such representative shall have the
right to meet with management and officers of Borrower to discuss such books of account and records. In addition, Agent or
the Lenders shall be entitled at reasonable times and intervals and upon reasonable prior written notice to consult with and
advise the management and officers of Borrower concerning significant business issues affecting Borrower. Such
consultations shall not unreasonably interfere with Borrower’s business operations. The parties intend that the rights granted
Agent and the Lenders shall constitute “management rights” within the meaning of 29 C.F.R. Section 2510.3-101(d)(3)(ii),
but that any advice, recommendations or participation by Agent or the Lenders with respect to any business issues shall not be
deemed to give Agent or the Lenders, nor be deemed an exercise by Agent or the Lenders of, control over Borrower’s
management or policies.
1.4
Further Assurances. Borrower shall from time to time execute, deliver and file, alone or with Agent, any
financing statements, security agreements, collateral assignments, notices, control agreements, promissory notes or other
documents to perfect, give the highest priority to Agent’s Lien on the Collateral (subject to Permitted Liens) as Agent may
reasonably request from time to time or as otherwise specifically required under the Loan Documents. Borrower shall from
time to time procure any instruments or documents as may be reasonably requested by Agent, and take all further action that
may be necessary, or that Agent may reasonably request, to perfect and protect the Liens granted hereby and thereby in
accordance with the Loan Documents. In addition, and for such purposes only, Borrower hereby authorizes Agent
US-DOCS\130693051.4
37
to execute and deliver on behalf of Borrower and to file such financing statements (including an indication that the financing
statement covers “all assets or all personal property” of Borrower in accordance with Section 9-504 of the UCC), collateral
assignments, notices, control agreements, security agreements and other documents without the signature of Borrower either
in Agent’s name or in the name of Agent as agent and attorney-in-fact for Borrower. Borrower shall protect and defend
Borrower’s title to the Collateral and Agent’s Lien thereon against all Persons claiming any interest adverse to Borrower or
Agent other than Permitted Liens.
1.4
Indebtedness. Borrower shall not create, incur, assume, guarantee or be or remain liable with respect to any
Indebtedness, or permit any Subsidiary to do so, other than Permitted Indebtedness, or prepay any Subordinated
Indebtedness, prepay the PPP Loan or take any actions which impose on Borrower an obligation to prepay any Subordinated
Indebtedness or prepay the PPP Loan, except for (a) the conversion of Indebtedness into equity securities and the payment of
cash in lieu of fractional shares in connection with such conversion, (b) purchase money Indebtedness pursuant to its then
applicable payment schedule, (c) prepayment by any Subsidiary of (i) inter-company Indebtedness owed by such Subsidiary
to any Borrower, or (ii) if such Subsidiary is not a Borrower, intercompany Indebtedness owed by such Subsidiary to another
Subsidiary that is not a Borrower, (d) payments of principal and interest under the PPP Loan pursuant to the payment
schedule as of the closing date of such loan, (e) as otherwise permitted hereunder or approved in writing by Agent, or (f) the
Indebtedness under the Loan Documents pursuant to Section 2.5.
1.5
Collateral. Borrower shall at all times keep the Collateral, the Intellectual Property and all other property
and assets used in Borrower’s business or in which Borrower now or hereafter holds any interest free and clear from any
Liens whatsoever (except for Permitted Liens), and shall give Agent prompt written notice of any known legal process
affecting the Collateral, the Intellectual Property, such other property and assets, in each case, with a value in excess of
$250,000, or any Liens thereon, provided however, that the Collateral and such other property and assets may be subject to
Permitted Liens except that there shall be no Liens whatsoever on Intellectual Property. Borrower shall not agree with any
Person other than Agent or the Lenders not to encumber its property (other than holders of Permitted Liens). Borrower shall
not enter into or suffer to exist or become effective any agreement that prohibits or limits the ability of any Borrower to create,
incur, assume or suffer to exist any Lien upon any of its property (including Intellectual Property), whether now owned or
hereafter acquired, to secure its obligations under the Loan Documents to which it is a party other than (a) this Agreement and
the other Loan Documents, (b) any agreements governing any purchase money Liens or capital lease obligations otherwise
permitted hereby (in which case, any prohibition or limitation shall only be effective against the assets financed thereby) and
(c) customary restrictions on the assignment of leases, licenses and other agreements. Borrower shall cause its Subsidiaries to
protect and defend such Subsidiary’s title to its assets from and against all Persons claiming any interest adverse to such
Subsidiary, and Borrower shall cause its Subsidiaries at all times to keep such Subsidiary’s property and assets free and clear
from any known legal process or Liens whatsoever (except for Permitted Liens, provided however, that there shall be no Liens
whatsoever on Intellectual Property), and shall give Agent prompt written notice of any legal process affecting such
Subsidiary’s assets with a value in excess of $250,000.
1.6
Investments. Borrower shall not directly or indirectly acquire or own, or make any Investment in or to any
Person, or permit any of its Subsidiaries so to do, other than Permitted Investments.
US-DOCS\130693051.4
38
1.7
Distributions. Borrower shall not, and shall not allow any Subsidiary to, (a) repurchase or redeem any class
of stock or other Equity Interest other than pursuant to employee, director or consultant repurchase plans, stock option plans
or agreements, restricted stock agreements, or other similar agreements, provided, however, in each case the repurchase or
redemption price does not exceed the original consideration paid for such stock or Equity Interest, or (b) declare or pay any
cash dividend or make any other cash distribution on any class of stock or other Equity Interest, except that a Subsidiary may
pay dividends or make other distributions to Borrower or any Subsidiary of Borrower, or (c) lend money to any employees,
officers or directors or guarantee the payment of any such loans granted by a third party in excess of $250,000 in the
aggregate outstanding other than Permitted Investments or (d) waive, release or forgive any Indebtedness owed by any
employees, officers or directors in excess of $250,000 in the aggregate per fiscal year.
1.8
Transfers. Except for Permitted Transfers, Borrower shall not, and shall not allow any Subsidiary to,
voluntarily or involuntarily transfer, sell, lease, license, lend or in any other manner convey any equitable, beneficial or legal
interest in any material portion of its assets.
1.9
Mergers or Acquisitions. Other than Permitted In-Licenses, Borrower shall not merge or consolidate, or
permit any of its Subsidiaries to merge or consolidate, with or into any other business organization (other than mergers or
consolidations of (a) a Subsidiary which is not a Borrower into another Subsidiary or into Borrower or (b) a Borrower into
another Borrower), or acquire, or permit any of its Subsidiaries to acquire, in each case including for the avoidance of doubt
through a merger, purchase, in-licensing arrangement or any similar transaction, all or substantially all of the capital stock or
any property of another Person.
1.10
Taxes. Borrower shall, and shall cause each of its Subsidiaries to, pay when due all material Taxes of any
nature whatsoever now or hereafter imposed or assessed against Borrower or the Collateral or upon Borrower’s ownership,
possession, use, operation or disposition thereof or upon Borrower’s rents, receipts or earnings arising therefrom, unless the
same are being contested in good faith and by appropriate proceedings diligently conducted and for which adequate reserves
are being maintained in accordance with GAAP. Borrower shall, and shall cause each of its Subsidiaries to, file on or before
the due date therefor (taking into account proper extensions) all federal and state income Tax returns and other material Tax
returns required to be filed.
1.11
Corporate Changes. Neither Borrower nor any Subsidiary shall change its corporate name, legal form or
jurisdiction of formation without ten (10) days’ prior written notice to Agent. Neither Borrower nor any Subsidiary shall
suffer a Change in Control unless, as part of the transaction(s) resulting in such a Change in Control, the Secured
Obligations (other than inchoate indemnity obligations) are repaid in full in cash. Neither Borrower nor any Subsidiary shall
relocate its chief executive office or its principal place of business unless: (i) it has provided prior written notice to Agent;
and (ii) such relocation shall be within the continental United States of America. Neither Borrower nor any Domestic
Subsidiary or Eligible Foreign Subsidiary shall relocate any tangible item of Collateral with an aggregate value in excess of
$250,000 (other than
(x) sales of Inventory in the ordinary course of business, (y) relocations of mobile Equipment in the possession of its
employees or agents, and (z) relocations of Collateral from a location described on Exhibit B to another location described on
Exhibit B) unless (i) it has provided prompt written notice to Agent, (ii) such relocation is within the continental United
States of America and, (iii) if such relocation is to a third party bailee, it has delivered a bailee agreement in form and
substance reasonably acceptable to Agent.
US-DOCS\130693051.4
39
1.12
Deposit Accounts. Neither Borrower nor any Qualified Subsidiary shall maintain any Deposit Accounts, or
accounts holding Investment Property, except, in each case, with respect to which Agent has an Account Control Agreement;
provided that no Account Control Agreement is required for any of the existing restricted accounts listed in Schedule 7.12.
Notwithstanding the foregoing, on and prior to December 31, 2019, Borrower may maintain up to $1,000,000 in its account
with Pacific Western Bank, account number ending in [***].
1.13
Borrower shall notify Agent of each Subsidiary formed subsequent to the Closing Date and, within 20
days of formation, shall cause any such Subsidiary (except for an Excluded Subsidiary) to execute and deliver to Agent a
Joinder Agreement, provided that, with respect to any Subsidiary that is an Excluded Subsidiary at such time, immediately
upon any change in applicable tax laws that would result in such Subsidiary ceasing to be an Excluded Subsidiary, Borrower
shall cause such Subsidiary to execute and deliver to Agent a Joinder Agreement.
1.14
MSC Investment Conditions. At any time that the MSC Subsidiary has any assets or liabilities, Borrower
shall satisfy the MSC Investment Conditions at all times.
1.15
Notification of Event of Default. Borrower shall notify Agent promptly and in any case within three (3)
Business Days of Borrower obtaining knowledge of the occurrence of any Event of Default.
1.16
Post-Close Obligations. Notwithstanding any provision herein or in any other Loan Document to the
contrary, to the extent not actually delivered on or prior to the Closing Date, Borrower shall deliver to Agent (or its
designated agent):
(a)
On or before December 31, 2019, evidence satisfactory to Agent that Borrower has less than $15,000 in
deposit in its account held at Pacific Western Bank, account number ending in [***], for outstanding checks. Borrower
shall not deposit any additional funds or issue additional checks related to such account. Borrower shall close such
account when all currently outstanding checks are paid.
(b)
Within thirty (30) days after the Closing Date, Borrower shall deliver to Agent appropriate
endorsements evidencing lender loss payable, additional insured, and notice of cancellation endorsements in favor of
Agent with respect to all insurance policies required by Section 6.2 hereof.
1.17
Use of Proceeds. Borrower agrees that the proceeds of the Loans shall be used solely to refinance existing
indebtedness, to pay related fees and expenses in connection with this Agreement and for working capital and general
corporate purposes. The proceeds of the Loans Credit will not be used in violation of Anti-Corruption Laws or applicable
Sanctions.
1.18
Certain Subsidiary Voting Rights. Borrower shall not, and shall not permit any Subsidiary, to amend or
modify any governing document of any Excluded Subsidiary of that is a CFC or CFC Holdco the effect of which is to
require a vote of greater than 50.1% of the Equity Interests or voting rights of such Subsidiary for any decision or action of
such Subsidiary, other than with Agent’s written consent.
1.19
Compliance with Laws.
Borrower shall maintain, and shall cause its Subsidiaries to maintain, compliance
US-DOCS\130693051.4
40
in all material respects with all applicable laws, rules or regulations (including any law, rule or
US-DOCS\130693051.4
41
regulation with respect to the making or brokering of loans or financial accommodations), and shall, or cause its
Subsidiaries to, obtain and maintain all required governmental authorizations, approvals, licenses, franchises, permits or
registrations reasonably necessary in connection with the conduct of Borrower’s business.
Neither Borrower nor any of its Subsidiaries shall, nor shall Borrower or any of its Subsidiaries permit any
Affiliate to, directly or indirectly, knowingly enter into any documents, instruments, agreements or contracts with any Person
listed on the OFAC Lists. Neither Borrower nor any of its Subsidiaries shall, nor shall Borrower or any of its Subsidiaries,
permit any Affiliate to, directly or indirectly, (i) conduct any business or engage in any transaction or dealing with any
Blocked Person, including, without limitation, the making or receiving of any contribution of funds, goods or services to or
for the benefit of any Blocked Person, (ii) deal in, or otherwise engage in any transaction relating to, any property or interests
in property blocked pursuant to Executive Order No. 13224 or any similar executive order or other Anti-Terrorism Law, or
(iii) engage in or conspire to engage in any transaction that evades or avoids, or has the purpose of evading or avoiding, or
attempts to violate, any of the prohibitions set forth in Executive Order No. 13224 or other Anti-Terrorism Law.
Borrower has implemented and maintains in effect policies and procedures designed to ensure compliance
by the Borrower, its Subsidiaries and their respective directors, officers, employees and agents with Anti-Corruption Laws and
applicable Sanctions, and Borrower, its Subsidiaries and their respective officers and employees and to the knowledge of
Borrower its directors and agents, are in compliance with Anti-Corruption Laws and applicable Sanctions in all material
respects.
None of Borrower, any of its Subsidiaries or any of their respective directors, officers or employees, or to
the knowledge of Borrower, any agent for Borrower or its Subsidiaries that will act in any capacity in connection with or
benefit from the credit facility established hereby, is a Sanctioned Person. No Loan, use of proceeds or other transaction
contemplated by this Agreement will violate Anti-Corruption Laws or applicable Sanctions.
1.20
[Reserved.]
1.21
Transactions with Affiliates. Borrower shall not and shall not permit any Subsidiary to, directly or
indirectly, enter into or permit to exist any transaction of any kind with any Affiliate of Borrower or such Subsidiary on
terms that are less favorable to Borrower or such Subsidiary, as the case may be, than those that might be obtained in an
arm’s length transaction from a Person who is not an Affiliate of Borrower or such Subsidiary.
SECTION 8. RIGHT TO INVEST
8.1 The Lenders or their assignee or nominee (each, a “Hercules Purchaser”, and collectively, the “Hercules
Purchasers”) shall have the right, in its discretion, to participate in any Subsequent Financing in an amount of up to
$2,000,000 on the same terms, conditions and pricing afforded to other investors participating in such Subsequent Financing
under applicable laws and regulations; provided that with respect to any public offering of Borrower, Borrower agrees to use
commercially reasonable efforts to provide the Hercules Purchasers with the opportunity to invest in each such Subsequent
Financing if it is lawful to do so under applicable laws and regulations (or if the Subsequent Financing is an underwritten
public offering pursuant to a registration statement under the Securities Act of 1933, as amended (a “Registered Offering”), to
use
US-DOCS\130693051.4
42
commercially reasonable efforts to cause the underwriters for such offering to offer the Hercules Purchasers an
US-DOCS\130693051.4
43
allocation of securities in such offering if it is lawful to do so under applicable laws and regulations), on the same terms,
conditions and pricing afforded to other investors participating in such Subsequent Financing. Each Hercules Purchaser
purchasing Subsequent Financing Securities shall be an “accredited investor” as defined in Regulation D promulgated under
the Securities Act of 1933, as amended (the “Act”).
SECTION 9. EVENTS OF DEFAULT
The occurrence of any one or more of the following events shall be an Event of Default:
1.1
Payments. Borrower fails to pay (i) any scheduled payment of principal or interest due under this
Agreement or any of the other Loan Documents on the due date or (ii) any other payment due on the Secured Obligations
hereunder within three (3) Business Days; provided, however, that an Event of Default shall not occur on account of a
failure to pay due solely to an administrative or operational error of Agent or the Lenders or Borrower’s bank if Borrower
had the funds to make the payment when due and makes the payment within three (3) Business Days following Borrower’s
knowledge of such failure to pay; or
1.2
Covenants. Borrower breaches or defaults in the performance of any covenant or Secured Obligation
under this Agreement, or any of the other Loan Documents or any other agreement among Borrower, Agent and the Lenders,
and (a) with respect to a default under any covenant under this Agreement (other than under Sections 6, 7.4, 7.5, 7.6, 7.7, 7.8,
7.9, 7.14, 7.15, 7.16, 7.17, 7.18, 7.19 and 7.21), any other Loan Document, or any other agreement among Borrower, Agent
and the Lenders, such default continues for more than ten (10) days after the earlier of the date on which (i) Agent or the
Lenders has given notice of such default to Borrower and (ii) Borrower has actual knowledge of such default or (b) with
respect to a default under any of Sections 6, 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, 7.14, 7.15, 7.16, 7.17, 7.18, 7.19 and 7.21, the
occurrence of such default; or
1.3
Material Adverse Effect. A circumstance has occurred that could reasonably be expected to have a
Material Adverse Effect, provided that solely for purposes of this Section 9.3, the occurrence of any of the following, in
and of itself, shall not constitute a Material Adverse Effect: (a) adverse results or delays in any nonclinical or clinical trial
or (b) the denial, delay or limitation of approval of, or taking of any other regulatory action by, the FDA; provided that, in
determining whether a Material Adverse Effect has occurred, Agent’s primary, though not sole, consideration will be
whether Borrower has or will have sufficient cash resources to repay the Secured Obligations as and when due and the clear
intention of Borrower’s investors to continue to fund Borrower in the amounts and timeframe necessary, in Agent’s good
faith judgment, to enable Borrower to satisfy the Secured Obligations as they become due and payable is the most
significant criterion Agent shall consider in making any such determination.
1.4
Representations. Any representation or warranty made by Borrower in any Loan Document shall have
been false or misleading in any material respect when made or when deemed made; or
1.5
Insolvency. Borrower (A) (i) shall make an assignment for the benefit of creditors; or (ii) shall be unable
to pay its debts as they become due in the ordinary course of business, or be unable to pay or perform under the Loan
Documents; or (iii) shall file a voluntary petition in bankruptcy; or (iv) shall file any petition, answer, or document seeking
for itself any
US-DOCS\130693051.4
44
reorganization, arrangement, composition, readjustment, liquidation, dissolution or similar relief under any present or
future statute, law or regulation pertinent to such circumstances except as
US-DOCS\130693051.4
45
permitted under Section 7.10 of this Agreement; or (v) shall seek or consent to or acquiesce in the appointment of any trustee,
receiver, or liquidator of Borrower or of all or any substantial part (i.e., 33-1/3% or more) of the assets or property of
Borrower; or (vi) shall cease operations of its business as its business has normally been conducted, or terminate substantially
all of its employees; or (vii) Borrower or its directors or majority shareholders shall take any action initiating any of the
foregoing actions described in clauses (i) through (vi); or (B) either (i) forty- five (45) days shall have expired after the
commencement of an involuntary action against Borrower seeking reorganization, arrangement, composition, readjustment,
liquidation, dissolution or similar relief under any present or future statute, law or regulation, without such action being
dismissed or all orders or proceedings thereunder affecting the operations or the business of Borrower being stayed; or (ii) a
stay of any such order or proceedings shall thereafter be set aside and the action setting it aside shall not be timely appealed;
or (iii) Borrower shall file any answer admitting or not contesting the material allegations of a petition filed against Borrower
in any such proceedings; or (iv) the court in which such proceedings are pending shall enter a decree or order granting the
relief sought in any such proceedings; or (v) forty-five (45) days shall have expired after the appointment, without the consent
or acquiescence of Borrower, of any trustee, receiver or liquidator of Borrower or of all or any substantial part of the
properties of Borrower without such appointment being vacated; or
1.6
Attachments; Judgments. Any portion of Borrower’s assets in an amount greater than $250,000 is
attached or seized, or a levy is filed against any such assets that is not removed, rescinded or dismissed within thirty (30)
days, or a judgment or judgments is/are entered for the payment of money (not covered by independent third party insurance
as to which liability has not been rejected by such insurance carrier), individually or in the aggregate, of at least $250,000,
or Borrower is enjoined or in any way prevented by court order from conducting any part of its business; or
1.7
Other Obligations. The occurrence of any default (beyond any applicable grace or cure periods) under any
agreement or obligation of Borrower giving rise to the ability by the counterparty to accelerate any Indebtedness in excess of
$250,000.
1.8
Stop Trade. At any time, an SEC stop trade order or NASDAQ market trading suspension of the Common
Stock shall be in effect for five (5) consecutive days or five (5) days during a period of ten (10) consecutive days, excluding
in all cases a suspension of all trading on a public market, provided that Borrower shall not have been able to cure such
trading suspension within thirty (30) days of the notice thereof or list the Common Stock on another public market within
sixty (60) days of such notice.
SECTION 10. REMEDIES
1.1
General. Upon and during the continuance of any one or more Events of Default,
(i) Agent may, and at the direction of the Required Lenders shall, accelerate and demand payment of all or any part of the
outstanding Secured Obligations together with the applicable Prepayment Charge and declare them to be immediately due
and payable (provided, that upon the occurrence and during the continuance of an Event of Default of the type described in
Section 9.5, all of the outstanding Secured Obligations (including, without limitation, the Prepayment Charge and the End of
Term Charge) shall automatically be accelerated and made due and payable, in each case without any further notice or act).
Borrower hereby irrevocably appoints Agent as its lawful attorney-in-fact exercisable following the occurrence and during
the continuance of an Event of Default, (a) sign Borrower’s name on any invoice or bill of lading for any account or drafts
US-DOCS\130693051.4
46
against
US-DOCS\130693051.4
47
account debtors; (b) demand, collect, sue, and give releases to any account debtor for monies due, settle and adjust disputes
and claims about the accounts directly with account debtors, and compromise, prosecute, or defend any action, claim, case,
or proceeding about any Collateral (including filing a claim or voting a claim in any bankruptcy case in Agent’s or
Borrower’s name, as Agent may elect); (c) make, settle, and adjust all claims under Borrower’s insurance policies;
(d) pay, contest or settle any Lien, charge, encumbrance, security interest, or other claim in or to the Collateral, or any
judgment based thereon, or otherwise take any action to terminate or discharge the same; (e) transfer the Collateral into the
name of Agent or a third party as the UCC permits; (f) receive, open and dispose of mail addressed to Borrower; (g) endorse
Borrower’s name on any checks, payment instruments, or other forms of payment or security; and (h) notify all account
debtors to pay Agent directly. Borrower hereby appoints Agent as its lawful attorney- in-fact to sign Borrower’s name on any
documents necessary to perfect or continue the perfection of Agent’s security interest in the Collateral regardless of whether
an Event of Default has occurred until all outstanding Secured Obligations have been satisfied in full and the Loan
Documents have been terminated. Agent’s foregoing appointment as Borrower’s attorney in fact, and all of Agent’s rights and
powers, coupled with an interest, are irrevocable until all Secured Obligations have been fully repaid and performed and the
Loan Documents have been terminated. Agent may, and at the direction of the Required Lenders shall, exercise all rights and
remedies with respect to the Collateral under the Loan Documents or otherwise available to it under the UCC and other
applicable law, including the right to release, hold, sell, lease, liquidate, collect, realize upon, or otherwise dispose of all or
any part of the Collateral and the right to occupy, utilize, process and commingle the Collateral. All Agent’s rights and
remedies shall be cumulative and not exclusive.
1.2
Collection; Foreclosure. Upon the occurrence and during the continuance of any Event of Default, Agent
may, and at the direction of the Required Lenders shall, at any time or from time to time, apply, collect, liquidate, sell in one
or more sales, lease or otherwise dispose of, any or all of the Collateral, in its then condition or following any commercially
reasonable preparation or processing, in such order as Agent may elect. Any such sale may be made either at public or private
sale at its place of business or elsewhere. Borrower agrees that any such public or private sale may occur upon ten (10)
calendar days’ prior written notice to Borrower. Agent may require Borrower to assemble the Collateral and make it available
to Agent at a place designated by Agent that is reasonably convenient to Agent and Borrower. The proceeds of any sale,
disposition or other realization upon all or any part of the Collateral shall be applied by Agent in the following order of
priorities:
First, to Agent and the Lenders in an amount sufficient to pay in full Agent’s and the Lenders’ reasonable and
documented out-of-pocket costs and professionals’ and advisors’ fees and expenses as described in Section 11.12;
Second, to the Lenders in an amount equal to the then unpaid amount of the Secured Obligations (including
principal, interest, and the default rate interest pursuant to Section 2.4), in such order and priority as Agent may
choose in its sole discretion; and
Finally, after the full and final payment in Cash of all of the Secured Obligations (other than inchoate
obligations), to any creditor holding a junior Lien on the Collateral, or to Borrower or its representatives or as a
court of competent jurisdiction may direct.
Agent shall be deemed to have acted reasonably in the custody, preservation and disposition of any of the Collateral if it complies
with the obligations of a secured party under the UCC.
US-DOCS\130693051.4
48
1.3
No Waiver. Agent shall be under no obligation to marshal any of the Collateral for the benefit of
Borrower or any other Person, and Borrower expressly waives all rights, if any, to require Agent to marshal any Collateral.
1.4
Cumulative Remedies. The rights, powers and remedies of Agent hereunder shall be in addition to all
rights, powers and remedies given by statute or rule of law and are cumulative. The exercise of any one or more of the rights,
powers and remedies provided herein shall not be construed as a waiver of or election of remedies with respect to any other
rights, powers and remedies of Agent.
SECTION 11. MISCELLANEOUS
1.1
Severability. Whenever possible, each provision of this Agreement shall be interpreted in such manner as
to be effective and valid under applicable law, but if any provision of this Agreement shall be prohibited by or invalid
under such law, such provision shall be ineffective only to the extent and duration of such prohibition or invalidity, without
invalidating the remainder of such provision or the remaining provisions of this Agreement.
1.2
Notice. Except as otherwise provided herein, any notice, demand, request, consent, approval, declaration,
service of process or other communication (including the delivery of Financial Statements) that is required, contemplated, or
permitted under the Loan Documents or with respect to the subject matter hereof shall be in writing, and shall be deemed to
have been validly served, given, delivered, and received upon the earlier of: (i) the day of transmission by electronic mail or
hand delivery or delivery by an overnight express service or overnight mail delivery service; or (ii) the third calendar day
after deposit in the United States of America mails, with proper first class postage prepaid, in each case addressed to the party
to be notified as follows:
(a)
If to Agent:
HERCULES CAPITAL, INC.
Legal Department
Attention: Chief Legal Officer and Janice Bourque 400 Hamilton
Avenue, Suite 310
Palo Alto, CA 94301
email: legal@htgc.com and jbourque@htgc.com Telephone: 650-
289-3060
(b)
If to the Lenders:
HERCULES CAPITAL, INC.
Legal Department
Attention: Chief Legal Officer and Janice Bourque 400 Hamilton
Avenue, Suite 310
Palo Alto, CA 94301
email: legal@htgc.com and jbourque@htgc.com Telephone: 650-
289-3060
(c)
If to Borrower:
US-DOCS\130693051.4
49
KALEIDO BIOSCIENCES, INC.
US-DOCS\130693051.4
50
Attention: Dan Menichella, CEO 65 Hayden
Avenue
Lexington, MA 02421
email: dan.menichella@kaleido.com Telephone: 617-890-
5735
with a copy (which shall not constitute notice) to:
GOODWIN PROCTER LLP
100 Northern Avenue
Boston, MA 02210 Attention: Mark D.
Smith Telephone: 617-570-1750
email: marksmith@goodwinprocter.com
or to such other address as each party may designate for itself by like notice.
1.3
Entire Agreement; Amendments.
(a)
This Agreement and the other Loan Documents constitute the entire agreement and understanding of
the parties hereto in respect of the subject matter hereof and thereof, and supersede and replace in their entirety any prior
proposals, term sheets, non-disclosure or confidentiality agreements, letters, negotiations or other documents or
agreements, whether written or oral, with respect to the subject matter hereof or thereof (including Agent’s revised
proposal letter dated November 22, 2019 and the Non-Disclosure Agreement).
(b)
Neither this Agreement, any other Loan Document, nor any terms hereof or thereof may be amended,
supplemented or modified except in accordance with the provisions of this Section 11.3(b). The Required Lenders and
Borrower party to the relevant Loan Document may, or, with the written consent of the Required Lenders, the Agent and the
Borrower party to the relevant Loan Document may, from time to time, (i) enter into written amendments, supplements or
modifications hereto and to the other Loan Documents for the purpose of adding any provisions to this Agreement or the
other Loan Documents or changing in any manner the rights of the Lenders or of the Borrower hereunder or thereunder or
(ii) waive, on such terms and conditions as the Required Lenders or the Agent, as the case may be, may specify in such
instrument, any of the requirements of this Agreement or the other Loan Documents or any default or Event of Default and
its consequences; provided, however, that no such waiver and no such amendment, supplement or modification shall (A)
forgive the principal amount or extend the final scheduled date of maturity of any Loan, extend the scheduled date of any
amortization payment in respect of any Term Loan, reduce the stated rate of any interest or fee payable hereunder or extend
the scheduled date of any payment thereof, in each case without the written consent of each Lender directly affected thereby;
(B) eliminate or reduce the voting rights of any Lender under this Section 11.3(b) without the written consent of such
Lender; (C) reduce any percentage specified in the definition of Required Lenders, consent to the assignment or transfer by
the Borrower of any of its rights and obligations under this Agreement and the other Loan Documents, release all or
substantially all of the Collateral or release a Borrower from its obligations under the Loan Documents, in each case without
the written consent of all Lenders; or
(D) amend, modify or waive any provision of Section 11.18 or Addendum 3 without the written consent of the Agent. Any
such waiver and any such amendment, supplement or modification shall apply equally to each Lender and shall be binding
upon Borrower, the Lender, the Agent
US-DOCS\130693051.4
51
and all future holders of the Loans.
US-DOCS\130693051.4
52
1.4
No Strict Construction. The parties hereto have participated jointly in the negotiation and drafting of
this Agreement. In the event an ambiguity or question of intent or interpretation arises, this Agreement shall be construed
as if drafted jointly by the parties hereto and no presumption or burden of proof shall arise favoring or disfavoring any
party by virtue of the authorship of any provisions of this Agreement.
1.5
No Waiver. The powers conferred upon Agent and the Lenders by this Agreement are solely to protect its
rights hereunder and under the other Loan Documents and its interest in the Collateral and shall not impose any duty upon
Agent or the Lenders to exercise any such powers. No omission or delay by Agent or the Lenders at any time to enforce any
right or remedy reserved to it, or to require performance of any of the terms, covenants or provisions hereof by Borrower at
any time designated, shall be a waiver of any such right or remedy to which Agent or the Lenders is entitled, nor shall it in
any way affect the right of Agent or the Lenders to enforce such provisions thereafter.
1.6
Survival. All agreements, representations and warranties contained in this Agreement and the other Loan
Documents or in any document delivered pursuant hereto or thereto shall be for the benefit of Agent and the Lenders and
shall survive the execution and delivery of this Agreement for so long as any Secured Obligations (other than contingent
obligations for which no claim has been asserted) remain outstanding. Sections 6.3, 11.14, 11.15 and 11.17 shall survive the
termination of this Agreement.
1.7
Successors and Assigns. The provisions of this Agreement and the other Loan Documents shall inure to the
benefit of and be binding on Borrower and its permitted assigns (if any). Borrower shall not assign its obligations under this
Agreement or any of the other Loan Documents without Agent’s express prior written consent, and any such attempted
assignment shall be void and of no effect. Agent and the Lenders may assign, transfer, or endorse its rights hereunder and
under the other Loan Documents without prior notice to Borrower, and all of such rights shall inure to the benefit of Agent’s
and the Lenders’ successors and assigns; provided that as long as no Event of Default has occurred and is continuing, neither
Agent nor any Lender may assign, transfer or endorse its rights hereunder or under the Loan Documents to any party that is a
direct competitor of Borrower (as reasonably determined by Borrower), a vulture hedge fund or any other party designated by
Borrower in writing on or prior to the Closing Date, it being acknowledged that in all cases, any transfer to an Affiliate of any
Lender or Agent shall be allowed. Agent will make reasonable efforts to provide Borrower with notice of any assignment,
transfer or endorsement at the time it is made or within a reasonable time thereafter other than any transfers to an Affiliate of
any Lender or Agent. Notwithstanding the foregoing, (x) in connection with any assignment by a Lender as a result of a
forced divestiture at the request of any regulatory agency, the restrictions set forth herein shall not apply and Agent and the
Lenders may assign, transfer or indorse its rights hereunder and under the other Loan Documents to any Person or party and
(y) in connection with a Lender’s own financing or securitization transactions, the restrictions set forth herein shall not apply
and Agent and the Lenders may assign, transfer or indorse its rights hereunder and under the other Loan Documents to any
Person or party providing such financing or formed to undertake such securitization transaction and any transferee of such
Person or party upon the occurrence of a default, event of default or similar occurrence with respect to such financing or
securitization transaction; provided that no such sale, transfer, pledge or assignment under this clause (y) shall release such
Lender from any of its obligations hereunder or substitute any such Person or party for such Lender as a party hereto until
Agent shall have received and accepted an effective assignment agreement from such Person or party in form satisfactory to
Agent executed, delivered and fully completed by the applicable parties thereto, and shall have
US-DOCS\130693051.4
53
received such other information regarding such assignee as Agent reasonably shall require. The Agent, acting solely for this
purpose as an agent of the Borrower, shall maintain at one of its offices in the United States a register for the recordation of
the names and addresses of the Lender(s), and the Term Commitments of, and principal amounts (and stated interest) of the
Loans owing to, each Lender pursuant to the terms hereof from time to time (the “Register”). The entries in the Register shall
be conclusive absent manifest error, and the Borrower, the Agent and the Lender(s) shall treat each Person whose name is
recorded in the Register pursuant to the terms hereof as a Lender hereunder for all purposes of this Agreement. The Register
shall be available for inspection by the Borrower and any Lender, at any reasonable time and from time to time upon
reasonable prior notice.
1.8
Participations. Each Lender that sells a participation shall, acting solely for this purpose as a non-fiduciary
agent of the Borrower, maintain a register on which it enters the name and address of each participant and the principal
amounts (and stated interest) of each participant’s interest in the Loans or other obligations under the Loan Documents (the
“Participant Register”); provided that no Lender shall have any obligation to disclose all or any portion of the Participant
Register (including the identity of any participant or any information relating to a participant's interest in any commitments,
loans, its other obligations under any Loan Document) to any Person except to the extent that such disclosure is necessary to
establish that such commitment, loan, letter of credit or other obligation is in registered form under Section 5f.103-1(c) of the
United States Treasury Regulations. The entries in the Participant Register shall be conclusive absent manifest error, and such
Lender shall treat each Person whose name is recorded in the Participant Register as the owner of such participation for all
purposes of this Agreement notwithstanding any notice to the contrary. For the avoidance of doubt, the Agent (in its capacity
as Agent) shall have no responsibility for maintaining a Participant Register. Borrower agrees that each participant shall be
entitled to the benefits of the provisions in Addendum 1 attached hereto (subject to the requirements and limitations therein,
including the requirements under Section 7 of Addendum 1 attached hereto (it being understood that the documentation
required under Section 7 of Addendum 1 attached hereto shall be delivered to the participating Lender)) to the same extent as
if it were a Lender and had acquired its interest by assignment pursuant to Section 11.7; provided that such participant shall
not be entitled to receive any greater payment under Addendum 1 attached hereto, with respect to any participation, than its
participating Lender would have been entitled to receive, except to the extent such entitlement to receive a greater payment
results from a change in law that occurs after the participant acquired the applicable participation.
1.9
Governing Law. This Agreement and the other Loan Documents have been negotiated and delivered to
Agent and the Lenders in the State of California, and shall have been accepted by Agent and the Lenders in the State of
California. Payment to Agent and the Lenders by Borrower of the Secured Obligations is due in the State of California. This
Agreement and the other Loan Documents shall be governed by, and construed and enforced in accordance with, the laws of
the State of California, excluding conflict of laws principles that would cause the application of laws of any other
jurisdiction.
1.10
Consent to Jurisdiction and Venue. All judicial proceedings (to the extent that the reference requirement of
Section 11.11 is not applicable) arising in or under or related to this Agreement or any of the other Loan Documents may be
brought in any state or federal court located in the State of California. By execution and delivery of this Agreement, each
party hereto generally and unconditionally: (a) consents to nonexclusive personal jurisdiction in Santa Clara County, State of
California; (b) waives any objection as to jurisdiction or venue in Santa Clara County, State of California; (c) agrees not to
assert any defense based on lack of jurisdiction or
US-DOCS\130693051.4
54
venue in the aforesaid courts; and (d) irrevocably agrees to be bound by any judgment rendered thereby in connection with
this Agreement or the other Loan Documents. Service of process on any party hereto in any action arising out of or relating to
this Agreement shall be effective if given in accordance with the requirements for notice set forth in Section 11.2, and shall be
deemed effective and received as set forth in Section 11.2. Nothing herein shall affect the right to serve process in any other
manner permitted by law or shall limit the right of either party to bring proceedings in the courts of any other jurisdiction.
1.11
Mutual Waiver of Jury Trial / Judicial Reference.
(a)
Because disputes arising in connection with complex financial transactions are most quickly and
economically resolved by an experienced and expert Person and the parties wish applicable state and federal laws to apply
(rather than arbitration rules), the parties desire that their disputes be resolved by a judge applying such applicable laws.
EACH OF BORROWER, AGENT AND THE LENDERS SPECIFICALLY WAIVES ANY RIGHT IT MAY HAVE TO
TRIAL BY JURY OF ANY CAUSE OF ACTION, CLAIM, CROSS-CLAIM, COUNTERCLAIM, THIRD PARTY
CLAIM OR ANY OTHER CLAIM (COLLECTIVELY, “CLAIMS”) ASSERTED BY BORROWER AGAINST AGENT,
THE LENDERS OR THEIR RESPECTIVE ASSIGNEE OR BY AGENT, THE LENDERS OR THEIR RESPECTIVE
ASSIGNEE AGAINST BORROWER. This waiver extends to all such Claims without limitation and any Claims for
damages, breach of contract, tort, specific performance, or any equitable or legal relief of any kind, arising out of this
Agreement, or any other Loan Document (other than to the extent arising from Agent or any Lender’s gross negligence or
willful misconduct).
(b)
If the waiver of jury trial set forth in Section 11.11(a) is ineffective or unenforceable, the parties agree
that all Claims shall be resolved by reference to a private judge sitting without a jury, pursuant to Code of Civil Procedure
Section 638, before a mutually acceptable referee or, if the parties cannot agree, a referee selected by the Presiding Judge
of the Santa Clara County, California. Such proceeding shall be conducted in Santa Clara County, California, with
California rules of evidence and discovery applicable to such proceeding.
(c)
In the event Claims are to be resolved by judicial reference, either party may seek from a court identified
in Section 11.10, any prejudgment order, writ or other relief and have such prejudgment order, writ or other relief enforced to
the fullest extent permitted by law notwithstanding that all Claims are otherwise subject to resolution by judicial reference.
1.12
Professional Fees. Borrower promises to pay Agent’s and the Lenders’ fees and reasonable and
documented out-of-pocket expenses necessary to finalize the loan documentation, including but not limited to reasonable and
documented out-of-pocket attorneys’ fees, UCC searches, filing costs, and other miscellaneous expenses. In addition,
Borrower promises to pay any and all reasonable and documented out-of-pocket attorneys’ and other professionals’ fees and
expenses incurred by Agent and the Lenders after the Closing Date in connection with or related to: (a) the Loan; (b) the
administration, collection, or enforcement of the Loan; (c) the amendment or modification of the Loan Documents; (d) any
waiver, consent, release, or termination under the Loan Documents; (e) the protection, preservation, audit, field exam, sale,
lease, liquidation, or disposition of Collateral or the exercise of remedies with respect to the Collateral; (f) any legal,
litigation, administrative, arbitration, or out of court proceeding in connection with or related to Borrower or the Collateral,
and any appeal or review thereof; and (g) any bankruptcy, restructuring, reorganization, assignment for the benefit of
creditors, workout, foreclosure, or other action related to Borrower, the Collateral, the Loan Documents, including
representing
US-DOCS\130693051.4
55
Agent or
US-DOCS\130693051.4
56
the Lenders in any adversary proceeding or contested matter commenced or continued by or on behalf of Borrower’s
estate, and any appeal or review thereof.
1.13
Confidentiality. Agent and the Lenders acknowledge that certain items of Collateral and information
provided to Agent and the Lenders by Borrower are confidential and proprietary information of Borrower, if and to the extent
such information either (x) is marked as confidential by Borrower at the time of disclosure, or (y) should reasonably be
understood to be confidential (the “Confidential Information”). Accordingly, Agent and the Lenders agree that any
Confidential Information it may obtain in the course of acquiring, administering, or perfecting Agent’s security interest in the
Collateral shall not be disclosed to any other Person or entity in any manner whatsoever, in whole or in part, without the prior
written consent of Borrower, except that Agent and the Lenders may disclose any such information: (a) to its Affiliates and its
partners, investors, lenders, directors, officers, employees, agents, advisors, counsel, accountants, counsel, representative and
other professional advisors if Agent or the Lenders in their reasonable good- faith discretion determines that any such party
should have access to such information in connection with such party’s responsibilities in connection with the Loan or this
Agreement and, provided that such recipient of such Confidential Information either (i) agrees to be bound by the
confidentiality provisions of this paragraph or (ii) is otherwise subject to confidentiality restrictions that reasonably protect
against the disclosure of Confidential Information which are no less restrictive than the terms of this Section 11.13; (b) if such
information is generally available to the public or to the extent such information becomes publicly available other than as a
result of a breach of this Section or becomes available to Agent or any Lender, or any of their respective Affiliates on a non-
confidential basis from a source other than the Borrower; (c) if required in any report, statement or testimony to be submitted
to any governmental authority having or claiming to have jurisdiction over Agent or the Lenders and any rating agency; (d) if
required or appropriate in response to any summons or subpoena or in connection with any litigation, to the extent permitted
or deemed advisable by Agent’s or the Lenders’ counsel; (e) to comply with any legal requirement or law applicable to Agent
or the Lenders or demanded by any governmental authority; (f) to the extent reasonably necessary in connection with the
exercise of, or preparing to exercise, or the enforcement of, or preparing to enforce, any right or remedy under any Loan
Document (including Agent’s sale, lease, or other disposition of Collateral during the continuance of an Event of Default), or
any action or proceeding relating to any Loan Document; (g) to any participant or assignee of Agent or the Lenders or any
prospective participant or assignee, provided, that such participant or assignee or prospective participant or assignee agrees in
writing to be bound by confidentiality restrictions similar to those under this Section 11.13; (h) otherwise to the extent
consisting of general portfolio information that does not identify Borrower; or (i) otherwise with the prior written consent of
Borrower; provided, that any disclosure made in violation of this Agreement shall not affect the obligations of Borrower or
any of its Affiliates or any guarantor under this Agreement or the other Loan Documents. Agent’s and the Lenders’
obligations under this Section 11.13 shall supersede all of their respective obligations under the Non-Disclosure Agreement.
1.14
Assignment of Rights. Borrower acknowledges and understands that Agent or the Lenders may, subject to
Section 11.7, sell and assign all or part of its interest hereunder and under the Loan Documents to any Person or entity (an
“Assignee”). After such assignment the term “Agent” or “Lender” as used in the Loan Documents shall mean and include
such Assignee, and such Assignee shall be vested with all rights, powers and remedies of Agent and the Lenders hereunder
with respect to the interest so assigned; but with respect to any such interest not so transferred, Agent and the Lenders shall
retain all rights, powers and remedies hereby given. No such assignment by Agent or the Lenders shall relieve Borrower of
any of its obligations
US-DOCS\130693051.4
57
hereunder. the Lenders agrees that in the event of any transfer by it of the promissory note(s) (if any), it will endorse thereon
a notation as to the portion of the principal of the promissory note(s), which shall have been paid at the time of such transfer
and as to the date to which interest shall have been last paid thereon.
1.15
Revival of Secured Obligations. This Agreement and the Loan Documents shall remain in full force and
effect and continue to be effective if any petition is filed by or against Borrower for liquidation or reorganization, if Borrower
becomes insolvent or makes an assignment for the benefit of creditors, if a receiver or trustee is appointed for all or any
significant part of Borrower’s assets, or if any payment or transfer of Collateral is recovered from Agent or the Lenders. The
Loan Documents and the Secured Obligations and Collateral security shall continue to be effective, or shall be revived or
reinstated, as the case may be, if at any time payment and performance of the Secured Obligations or any transfer of
Collateral to Agent, or any part thereof is rescinded, avoided or avoidable, reduced in amount, or must otherwise be restored
or returned by, or is recovered from, Agent, the Lenders or by any obligee of the Secured Obligations, whether as a “voidable
preference,” “fraudulent conveyance,” or otherwise, all as though such payment, performance, or transfer of Collateral had
not been made. In the event that any payment, or any part thereof, is rescinded, reduced, avoided, avoidable, restored,
returned, or recovered, the Loan Documents and the Secured Obligations shall be deemed, without any further action or
documentation, to have been revived and reinstated until the Secured Obligations (other than contingent obligations for which
no claim has been asserted) are fully satisfied.
1.16
Counterparts. This Agreement and any amendments, waivers, consents or supplements hereto may be
executed in any number of counterparts, and by different parties hereto in separate counterparts, each of which when so
delivered shall be deemed an original, but all of which counterparts shall constitute but one and the same instrument. Delivery
of an executed counterpart signature page of this Agreement by telecopier or other electronic means shall be effective as
delivery of a manually executed counterpart of this Agreement.
1.17
No Third Party Beneficiaries. No provisions of the Loan Documents are intended, nor will be interpreted,
to provide or create any third-party beneficiary rights or any other rights of any kind in any Person other than Agent, the
Lenders and Borrower unless specifically provided otherwise herein, and, except as otherwise so provided, all provisions of
the Loan Documents will be personal and solely among Agent, the Lenders and the Borrower.
1.18
Agency. Agent and each Lender hereby agree to the terms and conditions set forth on Addendum 3
attached hereto. Borrower acknowledges and agrees to the terms and conditions set forth on Addendum 3 attached
hereto.
1.19
Publicity. None of the parties hereto nor any of its respective member businesses and Affiliates shall,
without the other parties’ prior written consent, publicize or use (a) the other party's name (including a brief description of
the relationship among the parties hereto), logo or hyperlink to such other parties’ web site, separately or together, in written
and oral presentations, advertising, promotional and marketing materials, client lists, public relations materials or on its web
site (together, the "Publicity Materials"); (b) the names of officers of such other parties in the Publicity Materials; and (c)
such other parties’ name, trademarks, service marks in any news or press release concerning such party; provided however,
notwithstanding anything to the contrary herein, no such consent shall be required (i) to the extent necessary to comply with
the requests of any regulators, legal requirements or laws applicable to such party, pursuant to any listing
US-DOCS\130693051.4
58
agreement with any national securities exchange (so long as such party provides prior notice to the other party hereto to the
extent reasonably practicable) and (ii) to comply with Section 11.13.
1.20
Multiple Borrowers. Each Borrower hereby agrees to the terms and conditions set forth on Addendum 4
attached hereto.
(SIGNATURES TO FOLLOW)
US-DOCS\130693051.4
59
IN WITNESS WHEREOF, Borrower, Agent and the Lenders have duly executed and delivered this Loan and Security
Agreement as of the day and year first above written.
BORROWER:
KALEIDO BIOSCIENCES, INC.
Signature:
Print Name: Title:
CADENA BIO, INC.
Signature:
Print Name: Title:
(SIGNATURES CONTINUE ON THE FOLLOWING PAGE)
US-DOCS\130693051.4
60
Accepted in Palo Alto, California:
AGENT:
HERCULES CAPITAL, INC.
Signature:
Print Name:
Jennifer Choe
Title:
Assistant General Counsel
LENDERS:
HERCULES CAPITAL, INC.
Signature:
Print Name:
Jennifer Choe
Title:
Assistant General Counsel
US-DOCS\130693051.4
61
Table of Addenda, Exhibits and Schedules
Addendum 1: Taxes; Increased Costs Addendum 2:
[Reserved]
Addendum 3: Agent and Lender Terms Addendum 4:
Multiple Borrower Terms
Exhibit A:
Advance Request
Attachment to Advance Request
Exhibit B:
Name, Locations, and Other Information for Borrower Exhibit C:
Borrower’s
Patents, Trademarks, Copyrights and Licenses Exhibit D: Borrower’s Deposit Accounts and
Investment Accounts Exhibit E:
Compliance Certificate
Exhibit F:
Joinder Agreement
Exhibit G:
ACH Debit Authorization Agreement
Exhibit H-1: Form of U.S. Tax Compliance Certificate (For Foreign Lenders That Are Not Partnerships For U.S. Federal Income
Tax Purposes)
Exhibit H-2: Form of U.S. Tax Compliance Certificate (For Foreign Participants That Are Not Partnerships For U.S.
Federal Income Tax Purposes)
Exhibit H-3: Form of U.S. Tax Compliance Certificate (For Foreign Participants That Are Partnerships For U.S. Federal Income
Tax Purposes)
Exhibit H-4: Form of U.S. Tax Compliance Certificate (For Foreign Lenders That Are Partnerships For
U.S. Federal Income Tax Purposes)
Schedule 1.1 Commitments
Schedule 1
Subsidiaries
Schedule 1A Existing Permitted Indebtedness Schedule 1B
Existing Permitted Investments Schedule 1C
Existing
Permitted Liens Schedule 5.3 Consents, Etc.
Schedule 5.8 Tax Matters
Schedule 5.9 Intellectual Property Claims Schedule 5.10
Intellectual Property Schedule 5.11
Borrower Products
Schedule 5.14 Capitalization
Schedule 7.12 Deposit Accounts
US-DOCS\130693051.4
62
ADDENDUM 1 to LOAN AND SECURITY AGREEMENT TAXES;
INCREASED COSTS
1.
Defined Terms. For purposes of this Addendum 1:
a.
“Connection Income Taxes” means Other Connection Taxes that are imposed on or measured by net income
(however denominated) or that are franchise Taxes or branch profits Taxes.
b.
“Excluded Taxes” means any of the following Taxes imposed on or with respect to a Recipient or required to be
withheld or deducted from a payment to a Recipient, (i) Taxes imposed on or measured by net income (however
denominated), franchise Taxes, and branch profits Taxes, in each case, (A) imposed as a result of such Recipient being
organized under the laws of, or having its principal office or, in the case of any Lender, its applicable lending office
located in, the jurisdiction imposing such Tax (or any political subdivision thereof) or
(B) that are Other Connection Taxes, (ii) in the case of a Lender, U.S. federal withholding Taxes imposed on amounts
payable to or for the account of such Lender with respect to an applicable interest in a Loan or Term Commitment
pursuant to a law in effect on the date on which (A) such Lender acquires such interest in the Loan or Term
Commitment (other than pursuant to an assignment request by the Borrower under Section 10 of this Addendum 1)
or
(B) such Lender changes its lending office, except in each case to the extent that, pursuant to Section 2 or Section 4 of
this Addendum 1, amounts with respect to such Taxes were payable either to such Lender’s assignor immediately
before such Lender became a party hereto or to such Lender immediately before it changed its lending office, (iii)
Taxes attributable to such Recipient’s failure to comply with Section 7 of this Addendum 1 and (iv) any withholding
Taxes imposed under FATCA.
c.
“FATCA” means Sections 1471 through 1474 of the Code, as of the date of this Agreement (or any amended or
successor version that is substantively comparable and not materially more onerous to comply with), any current or
future regulations or official interpretations thereof, any agreements entered into pursuant to Section 1471(b)(1) of
the Code, and any fiscal or regulatory legislation, rules or practices adopted pursuant to any intergovernmental
agreement, treaty or convention among governmental authorities and implementing such Sections of the Code.
d.
“Foreign Lender” means a Lender that is not a U.S. Person.
e.
“Indemnified Taxes” means (i) Taxes, other than Excluded Taxes, imposed on or with respect to any payment made
by or on account of any obligation of the Borrower under any Loan Document and (ii) to the extent not otherwise
described in clause (i), Other Taxes.
f.
“Other Connection Taxes” means, with respect to any Recipient, Taxes imposed as a result of a present or former
connection between such Recipient and the jurisdiction imposing such Tax (other than connections arising from such
Recipient having executed, delivered, become a party to, performed its obligations under, received payments under,
received or perfected a security interest under, engaged in any other transaction pursuant to
US-DOCS\130693051.4
63
or enforced any Loan Document, or sold or assigned an interest in any Loan or Loan Document).
g.
“Other Taxes” means all present or future stamp, court or documentary, intangible, recording, filing or
similar Taxes that arise from any payment made under, from the
US-DOCS\130693051.4
64
execution, delivery, performance, enforcement or registration of, from the receipt or perfection of a security interest
under, or otherwise with respect to, any Loan Document, except any such Taxes that are Other Connection Taxes
imposed with respect to an assignment (other than an assignment made pursuant to Section 10(b) of this Addendum
1).
h.
“Recipient” means the Agent or any Lender, as applicable.
i.
“Withholding Agent” means the Borrower and the Agent.
3.
Payments Free of Taxes. Any and all payments by or on account of any obligation of the Borrower under any Loan Document
shall be made without deduction or withholding for any Taxes, except as required by applicable law. If any applicable law (as
determined in the good faith discretion of an applicable Withholding Agent) requires the deduction or withholding of any Tax
from any such payment by a Withholding Agent, then the applicable Withholding Agent shall be entitled to make such
deduction or withholding and shall timely pay the full amount deducted or withheld to the relevant governmental authority in
accordance with applicable law and, if such Tax is an Indemnified Tax, then the sum payable by the Borrower shall be
increased as necessary so that after such deduction or withholding has been made (including such deductions and withholdings
applicable to additional sums payable under this Section 2 or Section 4 of this Addendum 1) the applicable Recipient receives
an amount equal to the sum it would have received had no such deduction or withholding been made.
4.
Payment of Other Taxes by Borrower. The Borrower shall timely pay to the relevant governmental authority in accordance
with applicable law, or at the option of the Agent timely reimburse it for the payment of, any Other Taxes.
5.
Indemnification by Borrower. The Borrower shall indemnify each Recipient, within 10 days after demand therefor, for the full
amount of any Indemnified Taxes (including Indemnified Taxes imposed or asserted on or attributable to amounts payable under
Section 2 of this Addendum 1 or this Section 4) payable or paid by such Recipient or required to be withheld or deducted from a
payment to such Recipient and any reasonable expenses arising therefrom or with respect thereto, whether or not such
Indemnified Taxes were correctly or legally imposed or asserted by the relevant governmental authority. A certificate as to the
amount of such payment or liability delivered to the Borrower by a Lender (with a copy to the Agent), or by the Agent on its
own behalf or on behalf of a Lender, shall be conclusive absent manifest error. In addition, the Borrower agrees to pay, and to
save the Agent and any Lender harmless from, any and all liabilities with respect to, or resulting from any delay in paying, any
and all excise, sales or other similar taxes (excluding taxes imposed on or measured by the net income of the Agent or such
Lender) that may be payable or determined to be payable with respect to any of the Collateral or this Agreement.
6.
Indemnification by the Lenders. Each Lender shall severally indemnify the Agent, within 10 days after demand therefor, for
(a) any Indemnified Taxes attributable to such Lender (but only to the extent that the Borrower has not already indemnified the
Agent for such Indemnified Taxes and without limiting the obligation of the Borrower to do so), (b) any Taxes attributable to
such Lender’s failure to comply with the provisions of Section 11.8 of the Agreement relating to the maintenance of a
Participant Register and (c) any Excluded Taxes attributable to such Lender, in each case, that are payable or paid by the Agent
in connection with any Loan Document, and any reasonable expenses arising therefrom or with respect thereto, whether or not
such Taxes were correctly or legally imposed or asserted by the relevant governmental authority. A certificate as to the amount
of such payment or liability delivered to any Lender by the Agent shall be conclusive absent manifest
US-DOCS\130693051.4
65
error. Each Lender
US-DOCS\130693051.4
66
hereby authorizes the Agent to set off and apply any and all amounts at any time owing to such Lender under any Loan
Document or otherwise payable by the Agent to the Lender from any other source against any amount due to the Agent under
this Section 5.
6.
Evidence of Payments. As soon as practicable after any payment of Taxes by the Borrower to a governmental authority
pursuant to the provisions of this Addendum 1, the Borrower shall deliver to the Agent the original or a certified copy of a
receipt issued by such governmental authority evidencing such payment, a copy of the return reporting such payment or other
evidence of such payment reasonably satisfactory to the Agent.
7.
Status of Lenders.
a.
Any Lender that is entitled to an exemption from or reduction of withholding Tax with respect to payments made
under any Loan Document shall deliver to the Borrower and the Agent, at the time or times reasonably requested by
the Borrower or the Agent, such properly completed and executed documentation reasonably requested by the
Borrower or the Agent as will permit such payments to be made without withholding or at a reduced rate of
withholding. In addition, any Lender, if reasonably requested by the Borrower or the Agent, shall deliver such other
documentation prescribed by applicable law or reasonably requested by the Borrower or the Agent as will enable the
Borrower or the Agent to determine whether or not such Lender is subject to backup withholding or information
reporting requirements. Notwithstanding anything to the contrary in the preceding two sentences, the completion,
execution and submission of such documentation (other than such documentation set forth in Sections 7(b)(i), 7(b)(ii)
and 7(b)(iv) of this Addendum 1) shall not be required if in the Lender’s reasonable judgment such completion,
execution or submission would subject such Lender to any material unreimbursed cost or expense or would materially
prejudice the legal or commercial position of such Lender.
b.
Without limiting the generality of the foregoing,
i.
any Lender that is a U.S. Person shall deliver to the Borrower and the Agent on or prior to the date on which
such Lender becomes a Lender under this Agreement (and from time to time thereafter upon the reasonable
request of the Borrower or the Agent), executed copies of IRS Form W-9 certifying that such Lender is
exempt from U.S. federal backup withholding tax;
ii.
any Foreign Lender shall, to the extent it is legally entitled to do so, deliver to the Borrower and the Agent
(in such number of copies as shall be requested by the recipient) on or prior to the date on which such
Foreign Lender becomes a Lender under this Agreement (and from time to time thereafter upon the
reasonable request of the Borrower or the Agent), whichever of the following is applicable:
A.
in the case of a Foreign Lender claiming the benefits of an income tax treaty to which the United
States is a party (x) with respect to payments of interest under any Loan Document, executed
copies of IRS Form W-8BEN or IRS Form W-8BEN-E establishing an exemption from, or
reduction of, U.S. federal withholding Tax pursuant to the “interest” article of such tax treaty and
(y) with respect to any other applicable payments under any Loan Document, IRS Form W-8BEN
or IRS Form W-8BEN-E establishing an exemption from, or reduction of, U.S. federal withholding
US-DOCS\130693051.4
67
Tax pursuant to the “business profits” or “other income” article of such tax treaty;
US-DOCS\130693051.4
68
B.
executed copies of IRS Form W-8ECI;
C.
in the case of a Foreign Lender claiming the benefits of the exemption for portfolio interest under
Section 881(c) of the Code, (x) a certificate substantially in the form of Exhibit H-1 to the effect
that such Foreign Lender is not a “bank” within the meaning of Section 881(c)(3)(A) of the Code,
a “10 percent shareholder” of the Borrower within the meaning of Section 871(h)(3)(B) of the
Code, or a “controlled foreign corporation” related to the Borrower as described in Section 881(c)
(3)(C) of the Code (a “U.S. Tax Compliance Certificate”) and (y) executed copies of IRS Form
W-8BEN or IRS Form W-8BEN-E; or
D.
to the extent a Foreign Lender is not the beneficial owner, executed copies of IRS Form W-8IMY,
accompanied by IRS Form W-8ECI, IRS Form W- 8BEN, IRS Form W-8BEN-E, a U.S. Tax
Compliance Certificate substantially in the form of Exhibit H-2 or Exhibit H-3, IRS Form W-9,
and/or other certification documents from each beneficial owner, as applicable; provided that if the
Foreign Lender is a partnership and one or more direct or indirect partners of such Foreign Lender
are claiming the portfolio interest exemption, such Foreign Lender may provide a U.S. Tax
Compliance Certificate substantially in the form of Exhibit H-4 on behalf of each such direct and
indirect partner;
iv.
any Foreign Lender shall, to the extent it is legally entitled to do so, deliver to the Borrower and the Agent
(in such number of copies as shall be requested by the recipient) on or prior to the date on which such
Foreign Lender becomes a Lender under this Agreement (and from time to time thereafter upon the
reasonable request of the Borrower or the Agent), executed copies of any other form prescribed by
applicable law as a basis for claiming exemption from or a reduction in U.S. federal withholding Tax, duly
completed, together with such supplementary documentation as may be prescribed by applicable law to
permit the Borrower or the Agent to determine the withholding or deduction required to be made; and
v.
if a payment made to a Lender under any Loan Document would be subject to U.S. federal withholding Tax
imposed by FATCA if such Lender were to fail to comply with the applicable reporting requirements of
FATCA (including those contained in Section 1471(b) or 1472(b) of the Code, as applicable), such Lender
shall deliver to the Borrower and the Agent at the time or times prescribed by law and at such time or times
reasonably requested by the Borrower or the Agent such documentation prescribed by applicable law
(including as prescribed by Section 1471(b)(3)(C)(i) of the Code) and such additional documentation
reasonably requested by the Borrower or the Agent as may be necessary for the Borrower and the Agent to
comply with their obligations under FATCA and to determine that such Lender has complied with such
Lender’s obligations under FATCA or to determine the amount, if any, to deduct and withhold from such
payment. Solely for purposes of this clause (iv), “FATCA” shall include any amendments made to FATCA
after the date of this Agreement.
US-DOCS\130693051.4
69
c.
Each Lender agrees that if any form or certification it previously delivered expires or becomes obsolete or
inaccurate in any respect, it shall update such form or certification or promptly notify the Borrower and the Agent
in writing of its legal inability to do so.
9.
Treatment of Certain Refunds. If any party determines, in its sole discretion exercised in good faith, that it has received a
refund of any Taxes as to which it has been indemnified pursuant to the provisions of this Addendum 1 (including by the
payment of additional amounts pursuant to the provisions of this Addendum 1), it shall pay to the indemnifying party an amount
equal to such refund (but only to the extent of indemnity payments made under the provisions of this Addendum 1 with respect
to the Taxes giving rise to such refund), net of all reasonable and documented out-of-pocket expenses (including Taxes) of such
indemnified party and without interest (other than any interest paid by the relevant governmental authority with respect to such
refund). Such indemnifying party, upon the request of such indemnified party, shall repay to such indemnified party the amount
paid over pursuant to this Section 8 (plus any penalties, interest or other charges imposed by the relevant governmental
authority) in the event that such indemnified party is required to repay such refund to such governmental authority.
Notwithstanding anything to the contrary in this Section 8, in no event will the indemnified party be required to pay any amount
to an indemnifying party pursuant to this Section 8 the payment of which would place the indemnified party in a less favorable
net after-Tax position than the indemnified party would have been in if the Tax subject to indemnification and giving rise to such
refund had not been deducted, withheld or otherwise imposed and the indemnification payments or additional amounts with
respect to such Tax had never been paid. This Section 8 shall not be construed to require any indemnified party to make
available its Tax returns (or any other information relating to its Taxes that it deems confidential) to the indemnifying party or
any other Person.
10. Increased Costs. If any change in applicable law shall subject any Recipient to any Taxes (other than (A) Indemnified Taxes,
(B) Taxes described in clauses (ii) through (iv) of the definition of Excluded Taxes and (C) Connection Income Taxes) on its
loans, loan principal, commitments, or other obligations, or its deposits, reserves, other liabilities or capital attributable thereto,
and the result shall be to increase the cost to such Recipient of making, converting to, continuing or maintaining any Term Loan
or of maintaining its obligation to make any such Loan, or to reduce the amount of any sum received or receivable by such
Recipient (whether of principal, interest or any other amount), then, upon the request of such Recipient, the Borrower will pay to
such Recipient such additional amount or amounts as will compensate such Recipient for such additional costs incurred or
reduction suffered.
11. Mitigation Obligations; Replacement of Lenders.
a.
Designation of a Different Lending Office. If any Lender requests compensation under Section 9 of this Addendum
1, or requires the Borrower to pay any Indemnified Taxes or additional amounts to any Lender or any Governmental
Authority for the account of any Lender pursuant to this Addendum 1, then such Lender shall (at the request of the
Borrower) use reasonable efforts to designate a different lending office for funding or booking its Loans hereunder or
to assign its rights and obligations hereunder to another of its offices, branches or affiliates, if, in the judgment of such
Lender, such designation or assignment (i) would eliminate or reduce amounts payable by Borrower pursuant to this
Addendum 1, as the case may be, in the future, and (ii) would not subject such Lender to any unreimbursed cost or
expense and would not otherwise be disadvantageous to such Lender. The Borrower hereby agrees to pay all
reasonable costs and expenses incurred by any Lender in connection with any such designation or assignment.
US-DOCS\130693051.4
70
b.
Replacement of Lenders. If any Lender requests compensation under Section 9 of this Addendum 1, or if the
Borrower is required to pay any Indemnified Taxes or additional amounts to any Lender or any Governmental
Authority for the account of any Lender pursuant to this Addendum 1 and, in each case, such Lender has declined or
is unable to designate a different lending office in accordance with paragraph (a) of this Section, or if a Lender is a
Non-Consenting Lender, then the Borrower may, at its sole expense and effort, upon notice to such Lender and the
Administrative Agent, require such Lender to assign and delegate, without recourse (in accordance with and subject
to Section 11.7 of the Loan Agreement), all of its interests, rights (other than its existing rights to payments pursuant
to this Addendum 1) and obligations under this Loan Agreement and the related Loan Documents to an Assignee that
shall assume such obligations; provided that:
i.
such Lender shall have received payment of an amount equal to the outstanding principal of its Loans,
accrued interest thereon, accrued fees and all other amounts payable to it hereunder and under the other
Loan Documents) from the assignee (to the extent of such outstanding principal and accrued interest and
fees) or the Borrower (in the case of all other amounts);
ii.
in the case of any such assignment resulting from a claim for compensation under Section 9 of this
Addendum 1 or payments required to be made pursuant to this Addendum, such assignment will result in
a reduction in such compensation or payments thereafter;
iii.
such assignment does not conflict with applicable law; and
iv.
in the case of any assignment resulting from a Lender becoming a Non-Consenting Lender, the applicable
assignee shall have consented to the applicable amendment, waiver or consent.
A Lender shall not be required to make any such assignment or delegation if, prior thereto, as a result of a waiver
by such Lender or otherwise, the circumstances entitling the Borrower to require such assignment and delegation cease to apply.
12. Survival. Each party’s obligations under the provisions of this Addendum 1 shall survive the resignation or replacement of the
Agent or any assignment of rights by, or the replacement of, a Lender, the termination of the Term Commitments and the
repayment, satisfaction or discharge of all obligations under any Loan Document.
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
52
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
ADDENDUM 2 to LOAN AND SECURITY AGREEMENT
[Reserved]
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
ADDENDUM 3 to LOAN AND SECURITY AGREEMENT
Agent and Lender Terms
(a)
Each Lender hereby irrevocably appoints Hercules Capital, Inc. to act on its behalf as the Agent
hereunder and under the other Loan Documents and authorizes the Agent to take such actions on its behalf and to exercise
such powers as are delegated to the Agent by the terms hereof or thereof, together with such actions and powers as are
reasonably incidental thereto.
(b)
Each Lender agrees to indemnify the Agent in its capacity as such (to the extent not reimbursed by
Borrower and without limiting the obligation of Borrower to do so), according to its respective Term Commitment
percentages (based upon the total outstanding Term Loan Commitments) in effect on the date on which indemnification is
sought under this Addendum 3, from and against any and all liabilities, obligations, losses, damages, penalties, actions,
judgments, suits, costs, expenses or disbursements of any kind whatsoever that may at any time be imposed on, incurred by
or asserted against the Agent in any way relating to or arising out of, this Agreement, any of the other Loan Documents or
any documents contemplated by or referred to herein or therein or the transactions contemplated hereby or thereby or any
action taken or omitted by the Agent under or in connection with any of the foregoing; The agreements in this Section shall
survive the payment of the Loans and all other amounts payable hereunder.
(c)
Agent in Its Individual Capacity. The Person serving as the Agent hereunder shall have the same rights
and powers in its capacity as a Lender as any other Lender and may exercise the same as though it were not the Agent and
the term “Lender” shall, unless otherwise expressly indicated or unless the context otherwise requires, include each such
Person serving as Agent hereunder in its individual capacity.
(d)
Exculpatory Provisions. The Agent shall have no duties or obligations except those expressly set forth
herein and in the other Loan Documents. Without limiting the generality of the foregoing, the Agent shall not:
(i)
be subject to any fiduciary or other implied duties, regardless of whether any default or any Event of
Default has occurred and is continuing;
(ii) have any duty to take any discretionary action or exercise any discretionary powers, except
discretionary rights and powers expressly contemplated hereby or by the other Loan Documents that
the Agent is required to exercise as directed in writing by the Lenders, provided that the Agent shall
not be required to take any action that, in its opinion or the opinion of its counsel, may expose the
Agent to liability or that is contrary to any Loan Document or applicable law; and
(iii) except as expressly set forth herein and in the other Loan Documents, have any duty to disclose, and
the Agent shall not be liable for the failure to disclose, any information relating to the Borrower or
any of its Affiliates that is communicated to or obtained by any Person serving as the Agent or any
of its Affiliates in any capacity.
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
(e)
The Agent shall not be liable for any action taken or not taken by it (i) with the consent or at the
request of the Lenders or as the Agent shall believe in good faith shall be necessary, under the circumstances or (ii) in the
absence of its own gross negligence or willful misconduct.
(f)
The Agent shall not be responsible for or have any duty to ascertain or inquire into (i) any statement,
warranty or representation made in or in connection with this Agreement or any other Loan Document, (ii) the contents of
any certificate, report or other document delivered hereunder or thereunder or in connection herewith or therewith, (iii) the
performance or observance of any of the covenants, agreements or other terms or conditions set forth herein or therein or the
occurrence of any default or Event of Default, (iv) the validity, enforceability, effectiveness or genuineness of this
Agreement, any other Loan Document or any other agreement, instrument or document or (v) the satisfaction of any
condition set forth in Section 4 or elsewhere herein, other than to confirm receipt of items expressly required to be delivered
to the Agent. Reliance by Agent. Agent may rely, and shall be fully protected in acting, or refraining to act, upon, any
resolution, statement, certificate, instrument, opinion, report, notice, request, consent, order, bond or other paper or document
that it has no reason to believe to be other than genuine and to have been signed or presented by the proper party or parties
or, in the case of cables, telecopies and telexes, to have been sent by the proper party or parties. In the absence of its gross
negligence or willful misconduct, Agent may conclusively rely, as to the truth of the statements and the correctness of the
opinions expressed therein, upon any certificates or opinions furnished to Agent and conforming to the requirements of the
Loan Agreement or any of the other Loan Documents. Agent may consult with counsel, and any opinion or legal advice of
such counsel shall be full and complete authorization and protection in respect of any action taken, not taken or suffered by
Agent hereunder or under any Loan Documents in accordance therewith. Agent shall have the right at any time to seek
instructions concerning the administration of the Collateral from any court of competent jurisdiction. Agent shall not be
under any obligation to exercise any of the rights or powers granted to Agent by this Agreement, the Loan Agreement and
the other Loan Documents at the request or direction of the Lenders unless Agent shall have been provided by the Lenders
with adequate security and indemnity against the costs, expenses and liabilities that may be incurred by it in compliance with
such request or direction.
US-DOCS\130693051.4
ACTIVE/116115708.1
2
US-DOCS\130693242.5
ADDENDUM 4 to LOAN AND SECURITY AGREEMENT
Multiple Borrower Terms
(a)
Borrower’s Agent. Each of the Borrowers hereby irrevocably appoints Kaleido Biosciences, Inc. as its
agent, attorney-in-fact and legal representative for all purposes, including requesting disbursement of the Term Loan and
receiving account statements and other notices and communications to Borrowers (or any of them) from the Agent or any
Lender. The Agent may rely, and shall be fully protected in relying, on any request for the Term Loan, disbursement
instruction, report, information or any other notice or communication made or given by Kaleido Biosciences, Inc., whether
in its own name or on behalf of one or more of the other Borrowers, and the Agent shall not have any obligation to make any
inquiry or request any confirmation from or on behalf of any other Borrower as to the binding effect on it of any such
request, instruction, report, information, other notice or communication, nor shall the joint and several character of the
Borrowers’ obligations hereunder be affected thereby.
(b)
Waivers. Each Borrower hereby waives: (i) any right to require the Agent to institute suit against, or to
exhaust its rights and remedies against, any other Borrower or any other person, or to proceed against any property of any
kind which secures all or any part of the Secured Obligations, or to exercise any right of offset or other right with respect to
any reserves, credits or deposit accounts held by or maintained with the Agent or any Indebtedness of the Agent or any
Lender to any other Borrower, or to exercise any other right or power, or pursue any other remedy the Agent or any Lender
may have; (ii) any defense arising by reason of any disability or other defense of any other Borrower or any guarantor or any
endorser, co-maker or other person, or by reason of the cessation from any cause whatsoever of any liability of any other
Borrower or any guarantor or any endorser, co-maker or other person, with respect to all or any part of the Secured
Obligations, or by reason of any act or omission of the Agent or others which directly or indirectly results in the discharge or
release of any other Borrower or any guarantor or any other person or any Secured Obligations or any security therefor,
whether by operation of law or otherwise; (iii) any defense arising by reason of any failure of the Agent to obtain, perfect,
maintain or keep in force any Lien on, any property of any Borrower or any other person; (iv) any defense based upon or
arising out of any bankruptcy, insolvency, reorganization, arrangement, readjustment of debt, liquidation or dissolution
proceeding commenced by or against any other Borrower or any guarantor or any endorser, co-maker or other person,
including without limitation any discharge of, or bar against collecting, any of the Secured Obligations (including without
limitation any interest thereon), in or as a result of any such proceeding. Until all of the Secured Obligations have been paid,
performed, and discharged in full, nothing shall discharge or satisfy the liability of any Borrower hereunder except the full
performance and payment of all of the Secured Obligations. If any claim is ever made upon the Agent for repayment or
recovery of any amount or amounts received by the Agent in payment of or on account of any of the Secured Obligations,
because of any claim that any such payment constituted a preferential transfer or fraudulent conveyance, or for any other
reason whatsoever, and the Agent repays all or part of said amount by reason of any judgment, decree or order of any court
or administrative body having jurisdiction over the Agent or any of its property, or by reason of any settlement or
compromise of any such claim effected by the Agent with any such claimant (including without limitation the any other
Borrower), then and in any such event, each Borrower agrees that any such judgment, decree, order, settlement and
compromise shall be binding upon such Borrower, notwithstanding any revocation or release of this Agreement or the
cancellation of any note or other instrument evidencing any of the Secured Obligations, or any release of any of the Secured
US-DOCS\130693051.4
ACTIVE/116115708.1
3
US-DOCS\130693242.5
Obligations, and each Borrower shall be and remain liable to the Agent and the Lenders under
US-DOCS\130693051.4
ACTIVE/116115708.1
4
US-DOCS\130693242.5
this Agreement for the amount so repaid or recovered, to the same extent as if such amount had never originally been
received by the Agent or any Lender, and the provisions of this sentence shall survive, and continue in effect,
notwithstanding any revocation or release of this Agreement. Each Borrower hereby expressly and unconditionally waives
all rights of subrogation, reimbursement and indemnity of every kind against any other Borrower, and all rights of recourse
to any assets or property of any other Borrower, and all rights to any collateral or security held for the payment and
performance of any Secured Obligations, including (but not limited to) any of the foregoing rights which Borrower may have
under any present or future document or agreement with any other Borrower or other person, and including (but not limited
to) any of the foregoing rights which any Borrower may have under any equitable doctrine of subrogation, implied contract,
or unjust enrichment, or any other equitable or legal doctrine.
(c)
Consents. Each Borrower hereby consents and agrees that, without notice to or by Borrower and without
affecting or impairing in any way the obligations or liability of Borrower hereunder, the Agent may, from time to time before
or after revocation of this Agreement, do any one or more of the following in its sole and absolute discretion: (i) accept
partial payments of, compromise or settle, renew, extend the time for the payment, discharge, or performance of, refuse to
enforce, and release all or any parties to, any or all of the Secured Obligations; (ii) grant any other indulgence to any
Borrower or any other Person in respect of any or all of the Secured Obligations or any other matter; (iii) accept, release,
waive, surrender, enforce, exchange, modify, impair, or extend the time for the performance, discharge, or payment of, any
and all property of any kind securing any or all of the Secured Obligations or any guaranty of any or all of the Secured
Obligations, or on which the Agent at any time may have a Lien, or refuse to enforce its rights or make any compromise or
settlement or agreement therefor in respect of any or all of such property; (iv) substitute or add, or take any action or omit to
take any action which results in the release of, any one or more other Borrowers or any endorsers or guarantors of all or any
part of the Secured Obligations, including, without limitation one or more parties to this Agreement, regardless of any
destruction or impairment of any right of contribution or other right of Borrower; (v) apply any sums received from any
other Borrower, any guarantor, endorser, or co-signer, or from the disposition of any Collateral or security, to any
Indebtedness whatsoever owing from such person or secured by such Collateral or security, in such manner and order as the
Agent determines in its sole discretion, and regardless of whether such Indebtedness is part of the Secured Obligations, is
secured, or is due and payable. Each Borrower consents and agrees that the Agent shall be under no obligation to marshal
any assets in favor of Borrower, or against or in payment of any or all of the Secured Obligations. Each Borrower further
consents and agrees that the Agent shall have no duties or responsibilities whatsoever with respect to any property securing
any or all of the Secured Obligations. Without limiting the generality of the foregoing, the Agent shall have no obligation to
monitor, verify, audit, examine, or obtain or maintain any insurance with respect to, any property securing any or all of the
Secured Obligations.
(d)
Independent Liability. Each Borrower hereby agrees that one or more successive or concurrent actions
may be brought hereon against such Borrower, in the same action in which any other Borrower may be sued or in separate
actions, as often as deemed advisable by Agent. Each Borrower is fully aware of the financial condition of each other
Borrower and is executing and delivering this Agreement based solely upon its own independent investigation of all matters
pertinent hereto, and such Borrower is not relying in any manner upon any representation or statement of the Agent or any
Lender with respect thereto. Each Borrower represents and warrants that it is in a position to obtain, and each Borrower
hereby assumes full responsibility
US-DOCS\130693051.4
ACTIVE/116115708.1
5
US-DOCS\130693242.5
for obtaining, any additional information concerning any other Borrower’s financial condition
US-DOCS\130693051.4
ACTIVE/116115708.1
6
US-DOCS\130693242.5
and any other matter pertinent hereto as such Borrower may desire, and such Borrower is not relying upon or expecting
the Agent to furnish to it any information now or hereafter in the Agent’s possession concerning the same or any other
matter.
(e)
Subordination. All Indebtedness of a Borrower now or hereafter arising held by another Borrower is
subordinated to the Secured Obligations and the Borrower holding the Indebtedness shall take all actions reasonably
requested by Agent to effect, to enforce and to give notice of such subordination.
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
5
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
EXHIBIT A ADVANCE REQUEST
To: Agent:
Date:
, 20[ ]
Hercules Capital, Inc. (the “Agent”) 400 Hamilton
Avenue, Suite 310 Palo Alto, CA 94301
email: legal@htgc.com Attn:
Kaleido Biosciences, Inc., a Delaware corporation, on behalf of itself and each of its Subsidiaries party to the Agreement (collectively,
“Borrower”) hereby requests from Hercules Capital, Inc. (“Lenders”) an Advance in the amount of
Dollars ($
) (the
“Advance Amount”) on ,
(the “Advance Date”) pursuant to the Loan and Security Agreement among Borrower, Agent and the
Lenders (the “Agreement”). Capitalized words and other terms used but not otherwise defined herein are used with the same meanings
as defined in the Agreement.
Please:
(a)
Issue a check payable to Borrower
or
(b)
Wire Funds to Borrower’s account
[LAST 3 DIGITS] Bank:
Address:
ABA Number:
Account Number:
Account Name:
Contact Person:
Phone Number
To Verify Wire Info:
Email address:
Borrower represents that the conditions precedent to the Advance set forth in the Agreement are satisfied and shall be
satisfied upon the making of such Advance, including but not limited to: (i) that no event that has had or could reasonably be expected
to have a Material Adverse Effect has occurred and is continuing; (ii) that the representations and warranties set forth in the
Agreement are and shall be true and correct in all material respects on and as of the Advance Date with the same effect as though
made on and as of such date, except to the extent such representations and warranties expressly relate to an earlier date;
(iii)that Borrower is in compliance with all the terms and provisions set forth in each Loan Document on its part to be observed or
performed, which shall have been true and correct in all material respects as of such date; and (iv) that as of the Advance Date, no
fact or condition exists that would (or would, with the passage of time, the giving of notice, or both) constitute an Event of Default
under the Loan Documents. Borrower understands and acknowledges that Agent has the right to review the financial information
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
supporting this representation and, based upon such review in its sole discretion, the Lenders may decline to fund the requested
Advance.
Borrower hereby represents that Borrower’s corporate status and locations have not changed since the date of the
Agreement or, if the Attachment to this Advance Request is completed, are as set forth in the Attachment to this Advance Request.
Borrower agrees to notify Agent promptly before the funding of the Loan if any of the matters which have been represented
above shall not be true and correct on the Borrowing Date and if Agent has received no such notice before the Advance Date then the
statements set forth above shall be deemed to have been made and shall be deemed to be true and correct as of the Advance Date.
Executed as of [
], 20[ ].
BORROWER:
KALEIDO BIOSCIENCES, INC.
SIGNATURE:
TITLE:
PRINT NAME:
US-DOCS\130693051.4
ACTIVE/116115708.1
2
US-DOCS\130693242.5
ATTACHMENT TO ADVANCE REQUEST
Dated:
Borrower hereby represents and warrants to Agent that Borrower’s current name and organizational status is as follows:
Name:
Kaleido Biosciences, Inc.
Type of organization:
Corporation
State of organization:
Delaware
Organization file number:
47-3048279
Borrower hereby represents and warrants to Agent that the street addresses, cities, states and postal codes of its current locations are
as follows:
[ ]
Borrower hereby represents and warrants to Agent that the Advance Amount does not exceed the Maximum Term Loan
Amount as follows:
a.
Advance Amount: $
b.
[Maximum Term Loan Amount: $ ]
[c. Is clause a. less than or equal to clause b.? Yes/Compliant No/Non-Compliant ]
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
3
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
EXHIBIT B
NAME, LOCATIONS, AND OTHER INFORMATION FOR BORROWER
1.
Borrower represents and warrants to Agent that Borrower’s current name and organizational status as of the
Closing Date is as follows:
Name:
Kaleido Biosciences, Inc.
Type of organization:
Corporation
State of organization:
Delaware Organization file
number: 5681784
Name:
Cadena Bio, Inc.
Type of organization:
Corporation
State of organization:
Delaware Organization file
number: 6000485
2.
Borrower represents and warrants to Agent that for five (5) years prior to the Closing Date, Borrower did not do
business under any other name or organization or form except the following:
Name: VL32, Inc.
Used during dates of:
January, 2015 – November, 2015 Type of
Organization: Same as above.
State of organization:
Same as above. Organization file
Number: Same as above. Borrower’s fiscal year ends on
December 31
Borrower’s federal employer tax identification number is: 47-3048279
3.
Borrower represents and warrants to Agent that its chief executive office is located at 65 Hayden Avenue Lexington, MA
02421.
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
EXHIBIT C
BORROWER’S PATENTS, TRADEMARKS, COPYRIGHTS AND LICENSES
1)
Kaleido IP Assets
a)
Patents and Patent Applications:
U.S. 9,492,473, Glycan Therapeutics and Related Methods Thereof
U.S. 9,757,403, Glycan Therapeutics and Related Methods Thereof
U.S. 9,901,595, Glycan Therapeutics and Related Methods Thereof
U.S. 10,314,853, Glycan Therapeutics and Related Methods Thereof
EP 3071235 Glycan Therapeutic Compositions and Related Methods Thereof HK 1228788 Glycan
Therapeutic Compositions and Related Methods Thereof ZA 2017/04735 Glycan Therapeutic
Compositions and Related Methods Thereof Kaleido Portfolio Listing:
Application No.
Country
Status
Filing
Date
Application Title
15/017396
US
Granted
05-Feb-
2016
GLYCAN THERAPEUTICS
AND RELATED METHODS
THEREOF
15/286382
US
Granted
05-Oct-
2016
GLYCAN THERAPEUTICS
AND RELATED METHODS
THEREOF
15/385331
US
Granted
20-Dec-
2016
GLYCAN THERAPEUTICS
AND RELATED METHODS
THEREOF
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
Application No.
Country
Status
Filing
Date
Application Title
15/624372
US
Granted
15-Jun-
2017
GLYCAN THERAPEUTICS
AND RELATED METHODS
THEREOF
16/396067
US
Pending
26-Apr-
2019
GLYCAN THERAPEUTICS
AND RELATED METHODS
THEREOF
16/395929
US
Pending
26-Apr-
2019
GLYCAN THERAPEUTICS
AND RELATED METHODS
THEREOF
2016212030
AU
Published
13-Jan-
2016
GLYCAN THERAPEUTICS
AND RELATED METHODS
THEREOF
1120170156148
BR
Published
13-Jan-
2016
GLYCAN THERAPEUTICS
AND RELATED METHODS
THEREOF
2973617
CA
Published
13-Jan-
2016
GLYCAN THERAPEUTICS
AND RELATED METHODS
THEREOF
201701901
CL
Published
13-Jan-
2016
GLYCAN THERAPEUTICS
AND RELATED METHODS
THEREOF
201680017749.4
CN
Published
13-Jan-
2016
GLYCAN THERAPEUTICS
AND RELATED METHODS
THEREOF
201791702
EA
Published
13-Jan-
2016
GLYCAN THERAPEUTICS
AND RELATED METHODS
THEREOF
16704085.6
EP
Granted
13-Jan-
2016
GLYCAN THERAPEUTIC
COMPOSITIONS AND RELATED
METHODS THEREOF
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
Application No.
Country
Status
Filing
Date
Application Title
17206409.9
EP
Published
13-Jan-
2016
GLYCAN THERAPEUTIC
COMPOSITIONS AND RELATED
METHODS THEREOF
17102650.8
HK
Granted
13-Jan-
2016
GLYCAN THERAPEUTICS
AND RELATED METHODS
THEREOF
PID201704900
ID
Published
13-Jan-
2016
GLYCAN THERAPEUTICS
AND RELATED METHODS
THEREOF
P00201909582
ID
Pending
25-Oct-
2019
GLYCAN THERAPEUTICS
AND RELATED METHODS
THEREOF
253195
IL
Published
13-Jan-
2016
GLYCAN THERAPEUTICS
AND RELATED METHODS
THEREOF
201717026559
IN
Published
13-Jan-
2016
GLYCAN THERAPEUTICS
AND RELATED METHODS
THEREOF
2017-557273
JP
Published
13-Jan-
2016
GLYCAN THERAPEUTICS
AND RELATED METHODS
THEREOF
10-2017-7023785
KR
Pending
13-Jan-
2016
GLYCAN THERAPEUTICS
AND RELATED METHODS
THEREOF
MX/a/2017/009589
MX
Published
13-Jan-
2016
GLYCAN THERAPEUTICS
AND RELATED METHODS
THEREOF
PI2017001075
MY
Pending
13-Jan-
2016
GLYCAN THERAPEUTICS
AND RELATED METHODS
THEREOF
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
Application No.
Country
Status
Filing
Date
Application Title
733270
NZ
Pending
13-Jan-
2016
GLYCAN THERAPEUTICS
AND RELATED METHODS
THEREOF
1-2017-501342
PH
Published
13-Jan-
2016
GLYCAN THERAPEUTICS
AND RELATED METHODS
THEREOF
2017110006033
SG
Published
13-Jan-
2016
GLYCAN THERAPEUTICS
AND RELATED METHODS
THEREOF
PCT/US2016/013305
WO
Inactive
13-Jan-
2016
GLYCAN THERAPEUTICS
AND RELATED METHODS
THEREOF
2017/04735
ZA
Granted
13-Jan-
2016
GLYCAN THERAPEUTICS
AND RELATED METHODS
THEREOF
16/140091
US
Published
24-Sep-
2018
GLYCAN THERAPEUTIC
COMPOSITIONS AND RELATED
METHODS THEREOF
2016253010
AU
Published
23-Apr-
2016
GLYCAN THERAPEUTIC
COMPOSITIONS AND RELATED
METHODS THEREOF
2983236
CA
Published
23-Apr-
2016
GLYCAN THERAPEUTIC
COMPOSITIONS AND RELATED
METHODS THEREOF
201680035931.2
CN
Published
23-Apr-
2016
GLYCAN THERAPEUTIC
COMPOSITIONS AND RELATED
METHODS THEREOF
16722465.8
EP
Published
23-Apr-
2016
GLYCAN THERAPEUTICS
AND METHODS OF
TREATMENT
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
Application No.
Country
Status
Filing
Date
Application Title
18110824.1
HK
Pending
22-Aug-
2018
GLYCAN THERAPEUTICS
AND METHODS OF
TREATMENT
2017-555593
JP
Published
23-Apr-
2016
GLYCAN THERAPEUTIC
COMPOSITIONS AND RELATED
METHODS THEREOF
735895
NZ
Pending
23-Apr-
2016
GLYCAN THERAPEUTIC
COMPOSITIONS AND RELATED
METHODS THEREOF
PCT/US2016/029082
WO
Inactive
23-Apr-
2016
GLYCAN THERAPEUTICS
AND METHODS OF
TREATMENT
16/270051
US
Pending
07-Feb-
2019
MICROBIOME
REGULATORS AND
RELATED USES THEREOF
2016253011
AU
Published
23-Apr-
2016
MICROBIOME
REGULATORS AND
RELATED USES THEREOF
2983016
CA
Published
23-Apr-
2016
MICROBIOME
REGULATORS AND
RELATED USES THEREOF
201680036013.1
CN
Published
23-Apr-
2016
MICROBIOME
REGULATORS AND
RELATED USES THEREOF
16724150.4
EP
Published
23-Apr-
2016
MICROBIOME
REGULATORS AND
RELATED USES THEREOF
MX/a/2017/013562
MX
Published
23-Apr-
2016
MICROBIOME
REGULATORS AND
RELATED USES THEREOF
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
Application No.
Country
Status
Filing
Date
Application Title
735897
NZ
Pending
23-Apr-
2016
MICROBIOME
REGULATORS AND
RELATED USES THEREOF
PCT/US2016/029083
WO
Inactive
23-Apr-
2016
MICROBIOME
REGULATORS AND
RELATED USES THEREOF
2017/06675
ZA
Pending
23-Apr-
2016
MICROBIOME
REGULATORS AND
RELATED USES THEREOF
2016311452
AU
Published
25-Aug-
2016
GLYCAN COMPOSITIONS
AND USES THEREOF
2994430
CA
Published
25-Aug-
2016
GLYCAN COMPOSITIONS
AND USES THEREOF
201680059550.8
CN
Published
25-Aug-
2016
GLYCAN COMPOSITIONS
AND USES THEREOF
16778131.9
EP
Published
25-Aug-
2016
GLYCAN COMPOSITIONS
AND USES THEREOF
2018-510084
JP
Published
25-Aug-
2016
GLYCAN COMPOSITIONS
AND USES THEREOF
MX/a/2018/002301
MX
Published
25-Aug-
2016
GLYCAN COMPOSITIONS
AND USES THEREOF
739502
NZ
Pending
25-Aug-
2016
GLYCAN COMPOSITIONS
AND USES THEREOF
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
Application No.
Country
Status
Filing
Date
Application Title
15/754850
US
Published
25-Aug-
2016
GLYCAN COMPOSITIONS
AND USES THEREOF
PCT/US2016/048794
WO
Inactive
25-Aug-
2016
GLYCAN COMPOSITIONS
AND USES THEREOF
201780056075.3
CN
Published
13-Jul-
2017
GLYCAN COMPOSITIONS
AND METHODS OF USE
17746236.3
EP
Published
13-Jul-
2017
GLYCAN COMPOSITIONS
AND METHODS OF USE
2019-501469
JP
Published
13-Jul-
2017
GLYCAN COMPOSITIONS
AND METHODS OF USE
16/316755
US
Pending
10-Jan-
2019
GLYCAN COMPOSITIONS
AND METHODS OF USE
PCT/US2017/042022
WO
Inactive
13-Jul-
2017
GLYCAN COMPOSITIONS
AND METHODS OF USE
2017370682
AU
Published
06-Dec-
2017
GLYCAN POLYMERS AND
RELATED METHODS
THEREOF
3046207
CA
Published
06-Dec-
2017
GLYCAN POLYMERS AND
RELATED METHODS
THEREOF
201780075847.8
CN
Published
06-Dec-
2017
GLYCAN POLYMERS AND
RELATED METHODS
THEREOF
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
Application No.
Country
Status
Filing
Date
Application Title
17832599.9
EP
Published
06-Dec-
2017
GLYCAN POLYMERS AND
RELATED METHODS
THEREOF
2019-530061
JP
Pending
06-Dec-
2017
GLYCAN POLYMERS AND
RELATED METHODS
THEREOF
754185
NZ
Pending
06-Dec-
2017
GLYCAN POLYMERS AND
RELATED METHODS
THEREOF
16/466945
US
Published
05-Jun-
2019
GLYCAN POLYMERS AND
RELATED METHODS
THEREOF
PCT/US2017/064974
WO
Inactive
06-Dec-
2017
GLYCAN POLYMERS AND
RELATED METHODS
THEREOF
PCT/US2018/059100
WO
Published
03-Nov-
2018
GLYCAN PREPARATIONS
FOR THE TREATMENT OF
INFECTION
PCT/US2018/059102
WO
Published
03-Nov-
2018
GLYCAN PREPARATIONS AND
METHODS OF USE FOR
HYPERAMMONEMIA
PCT/US2018/059101
WO
Published
03-Nov-
2018
METHODS OF PRODUCING
GLYCAN POLYMERS
62/861252
US
Pending
13-Jun-
2019
GLYCAN PREPARATIONS
AND MICROBES
62/790671
US
Pending
10-Jan-
2019
GLYCAN PREPARATIONS AND
METHODS OF USE FOR
TREATING NON- ALCOHOLIC
FATTY LIVER DISEASE
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
Application No.
Country
Status
Filing
Date
Application Title
62/790631
US
Pending
10-Jan-
2019
GLYCAN PREPARATIONS
AND METHODS OF USE IN
RENAL DISEASES
62/880369
US
Pending
30-Jul-
2019
GLYCAN PREPARATIONS
AND METHODS OF USE IN
RENAL DISEASES
PCT/US2018/042174
WO
Published
13-Jul-
2018
GLYCAN COMPOSITIONS
AND METHODS OF USE
62/861268
US
Pending
13-Jun-
2019
COMPOSITIONS AND
METHODS
62/861256
US
Pending
13-Jun-
2019
COMPOSITIONS AND
METHODS
62/861270
US
Pending
13-Jun-
2019
COMPOSITIONS AND
METHODS
PCT/US2019/047595
WO
Pending
21-Aug-
2019
OLIGOSACCHARIDE
COMPOSITIONS AND
METHODS OF USE THEREOF
FOR REDUCING AMMONIA
LEVELS
PCT/US2019/060626
WO
Pending
8-Nov-
2019
OLIGOSACCHARIDE
COMPOSITIONS AND
METHODS OF USE THEREOF
62/791006
US
Pending
10-Jan-
2019
FORMULATIONS FOR
MODULATING MICROBIOME
ACTIVITY
62/845305
US
Pending
8-May-
2019
OLIGOSACCHARIDE
COMPOSITIONS AND
METHODS OF USE
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
Application No.
Country
Status
Filing
Date
Application Title
62/910179
US
Pending
3-Oct-
2019
OLIGOSACCHARIDE
COMPOSITIONS AND
METHODS OF USE
b)
Trademarks and/or service marks:
The following marks have been applied for but not yet granted, unless otherwise noted.
Mark
Country
Status
Serial No.
Filin g
Date
Reg. No.
Reg
.
Dat e
Clas s
KALEIDO
Canada
Allowed
1776706
11-
Apr-
16
N/A
KALEIDO
China
(People's
Republic)
Registere d
1314387
8-
Apr-
16
1314387
8-
Apr-
16
05
Int.
KALEIDO
European
Union
Registere d
01722407
2
20-
Sep-
17
01722407
2
17-
Jan-
18
01
Int.
KALEIDO
European
Union
Registere d
01794107
3
10-
Aug-
18
01794107
3
25-
Dec
-18
05
Int.
KALEIDO
Japan
Registere d
1314387
8-
Apr-
16
1314387
8-
Apr-
16
05
Int.
KALEIDO
Mexico
Registere d
1314387
8-
Apr-
16
1314387
8-
Apr-
16
05
Int.
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
KALEIDO
United States
of America
Allowed
86/78335
7
9-
Oct-
15
05
Int.
KALEIDO
Int'l Registratio
n - Madrid
Protocol
Registere d
A0057956
8-
Apr-
16
1314387
8-
Apr-
16
05
Int.;
42
Int.
United States
of America
Pending*
88/36961
2
3-
Apr-
19
05
Int.
United States
of America
Allowed
88/36964
4
3-
Apr-
19
05
Int.
Int'l Registratio
n
Registere d
2-
Oct-
19
1497529
2-
Oct-
19
05
Int.
MICROBIOM E
ENHANCER
United States
of America
Pending
87/19534
0
6-
Oct-
16
05
Int.
MMT
European
Union
Published
1482563
19-
Jun-
19
05
Int.
MMT
Japan
Pending
1482563
19-
Jun-
19
05
Int.
MMT
United States
of America
Published
88/23567
0
19-
Dec-
18
05
Int.
MMT
Int'l Registratio
n - Madrid
Protocol
Registere d
A0086981
19-
Jun-
19
1482563
19-
Jun-
19
05
Int.
* international filing for class 5 on October 2, 2019. Appl. # not yet available
c)
Copyright registrations or applications: None
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
d)
Domain names:
kaleido.com kaleidobio.com
caleidobio.com
kaleidobiosciences.com
kaleidotherapeutics.com kaleidotx.com
kaleidotx.net
vl32.com cadena-bio.com
cadena-bio.net cadena-
bio.org cadenabio.com
cadenabio.net
cadenahealth.com
3)
Cadena IP Assets (as of December 31, 2018):
a)
Patents and Patent Applications:
U.S. 8,466,242, Polymeric Acid Catalysts and Uses Thereof
U.S. 8,476,388, Polymeric Acid Catalysts and Uses Thereof
U.S. 9,079,171, Polymeric Acid Catalysts and Uses Thereof
U.S. 9,205,418, Polymeric Acid Catalysts and Uses Thereof
U.S. 10,131,721, Polymeric Acid Catalysts and Uses Thereof
U.S. 9,238,845, Methods of Producing Sugars from Biomass Feedstocks EP 2681547,
Polymeric Acid Catalysts and Uses Thereof
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
AR 085503B1, Polymeric Acid Catalysts and Uses Thereof
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
AU 2012223494, Polymeric Acid Catalysts and Uses Thereof CA 2,864,086,
Polymeric Acid Catalysts and Uses Thereof
CN ZL201280018901.2, Polymeric Acid Catalysts and Uses Thereof CO 30876, Polymeric
Acid Catalysts and Uses Thereof
ID 465560, Polymeric Acid Catalysts and Uses Thereof MX 344405, Polymeric
Acid Catalysts and Uses Thereof NZ 616047, Polymeric Acid Catalysts and
Uses Thereof SG 192958, Polymeric Acid Catalysts and Uses Thereof ZA
2013/06233 Polymeric Acid Catalysts and Uses Thereof
CN ZL201380055050.3, Polymeric and Solid-Supported Catalysts, and Methods of Digesting Cellulosic Materials Using such
Catalysts
Cadena Bio Portfolio Listing:
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
Title/Inventors
Pub. No.
Serial No.
C & E Ref.
Cadena Ref.
Status
Patent No. /
Issue date
1
POLYMERIC ACID CATALYSTS AND
U.S.S.N. 13/406,490*
51169-002003
CAD-001 US3
Granted
9,079,171
USES THEREOF
Filed 2/27/2012
7/14/2015
U.S.S.N. 13/406,517
51169-002004
CAD-001 US4
Granted
8,466,242
John M. Geremia
Filed 2/27/2012
6/18/2013
Brian M. Baynes
U.S.S.N. 13/657,724
51169-002005
CAD-001 US5
Granted
8,476,388
Ashish Dhawan
Filed 10/22/2012
7/2/2013
U.S.S.N. 13/865,048
51169-002006
CAD-001 US6
Granted
9,205,418
Filed 4/17/2013
12/8/2015
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
Title/Inventors
Pub. No.
Serial No.
C & E Ref.
Cadena Ref.
Status
Patent No. /
Issue date
Corresponding to International
U.S.S.N. 14/730,143*
51169-002007
CAD-001 US7
Granted
10,131,721
Application PCT/US2012/026820
filed 2/27/2012
Filed 6/3/2015
11/20/2018
U.S.S.N. 16/175,213
51169-002008
CAD-001US8
Published
Priority information:
Filed 10/30/2018
61/447,311 filed 2/28/2011
AR P20120100642
51169-002AR3
CAD-001 AR
Granted
AR085503B1
61/522,351 filed 8/11/2011
Filed 2/28/2012
08/30/2018
AU 2012223494
51169-002AU3
CAD-001 AU
Granted
2012223494
07/20/2017
BR1120130220473
51169-002BR3
CAD-001 BR
Pending
CA 2,864,086
51169-002CA3
CAD-001 CA
Granted
2,864,086
07/10/2018
CL 2463-2013
51169-002CL3
CAD-001 CL
Abandoned
CN 201280018901.2
51169-002CN3
CAD-001 CN
Granted
ZL201280018901.2
02/27/2018
CO 13230542
51169-002CO3
CAD-001 CO
Granted
30876
08/18/2015
EP 12709207.0
51169-002EP3
CAD-001 EP1
Granted
2681247
04/04/2018
EP 18163838.8
51169-002EP4
CAD-001 EP2
Published
ID W00201304395
51169-002ID3
CAD-001 ID
Granted
IDP0000465560
06/20/2017
IN 7946/DELNP/2013
51169-002IN3
CAD-001 IN
Pending
JM 18/1/5278
51169-002JM3
CAD-001 JM
Pending
KR 10-2013-7018658
51169-002KR3
CAD-001 KR
Abandoned
MX/a/2013/009920
51169-002MX3
CAD-001 MX
Granted
344405
12/14/2016
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
Title/Inventors
Pub. No.
Serial No.
C & E Ref.
Cadena Ref.
Status
Patent No. /
Issue date
MX/a/2015/016430
51169-002MX4
CAD-001 MX
Pending
MY PI 2013003157
51169-002MY3
CAD-001 MY
Abandoned
NZ 616047
51169-002NZ3
CAD-001 NZ
Granted
616047
3/30/2016
PH 1-2013-501775
51169-002PH3
CAD-001 PH
Pending
RU 2013143822
51169-002RU3
CAD-001 RU
Abandoned
SG 201306465-4
51169-002SG3
CAD-001 SG
Granted
192958
3/9/2016
TH 1301004754
51169-002TH3
CAD-001 TH
Pending
ZA 2013/06233
51169-002ZA3
CAD-001 ZA
Granted
2013/06233
12/20/2017
2
METHODS OF PRODUCING SUGARS
U.S.S.N. 13/831,495
51169-003001
CAD-006 US2
Granted
9,238,845
FROM BIOMASS FEEDSTOCKS
Filed 3/14/2013
1/19/2016
Brian M. Baynes
John M. Geremia
Joseph Andoh
Ashish Dhawan
Priority information:
61/693,210 filed 8/24/2012
3
POLYMERIC AND SOLID-SUPPORTED
U.S.S.N. 14/423,697*
51169-004004
CAD-004 US
Abandoned
CATALYSTS, AND METHODS OF
DIGESTING CELLULOSIC MATERIALS
USING SUCH CATALYSTS
Filed 2/24/2015
CA 2,922,254
51169-004CA4
CAD-004 CA
Abandoned
John M. Geremia
CN 201380055050.3
51169-004CN4
CAD-004 CN
Granted
ZL201380055050.3
4/12/2017
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
Title/Inventors
Pub. No.
Serial No.
C & E Ref.
Cadena Ref.
Status
Patent No. /
Issue date
Brian M. Baynes Jaouad
Fichtali Joseph Andoh
Corresponding to International Application
No. PCT/US2013/056389 filed 8/23/2013
Priority information: 61/693,200
filed 8/24/2012
61/693,210 filed 8/24/2012
61/693,213 filed 8/24/2012
13/831,495 filed 3/14/2013
EP 13831228.5
51169-004EP4
CAD-004 EP
Abandoned
KR 10-2015-7007481
51169-004KR4
CAD-004 KR
Abandoned
4
OLIGOSACCHARIDE COMPOSITIONS
AND METHODS FOR PRODUCING
THEREOF
John M. Geremia Anastasia V.
Murphy Scott Han
Benjamin A. Seigal Alicia
Landry
Kyle Sherry Stephan Panos
Devin Churchman Andrew
O’Connor
U.S.S.N. 14/795,720*
Filed 7/9/2015
51169-007003
CAD-012 US
Published
2015287703
51169-007AU3
CAD-012AU
Abandoned
2019222849
51169-007AU4
CAD-012AU1
Published
BR112017000345-7
51169-007BR3
CAD-012 BR
Pending
CA 2,954,662
51169-007CA3
CAD-012 CA
Pending
201580048065.6
51169-007CN3
CAD-012 CN
Published
15819734.3
51169-007EP3
CAD-012 EP
Published
17111776.8
51169-007HK3
CAD-012 HK
Pending
P00 2017 00913
51169-007ID3
CAD-012 ID
Pending
249982
51169-007IL3
CAD-012 IL
Pending
201717004105
51169-007IN3
CAD-012 IN
Pending
2017-522455
51169-007JP3
CAD-012 JP
Published
MX/a/2017/000319
51169-007MX3
CAD-012 MX
Pending
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
Title/Inventors
Pub. No.
Serial No.
C & E Ref.
Cadena Ref.
Status
Patent No. /
Issue date
Corresponding to International Application
No. PCT/US2015/039795 filed 7/9/2015
Priority information: 62/022,579
filed 7/9/2014
62/108,035 filed 1/26/2015
PI 2017000019
51169-007MY3
CAD-012 MY
Pending
5
OLIGOSACCHARIDE COMPOSITIONS
FOR USE AS FOOD INGREDIENTS AND
METHODS OF PRODUCING THEREOF
John M. Geremia Raffi
Mardirosian
Michael
J.
Gidding
Corresponding to International
Application PCT/US2016/013265 filed
January 13, 2016
Priority information: 62/108,036
filed 1/26/2015
U.S.S.N. 15/546,438
Filed 7/26/2017
51169-008002
CAD-013US
Abandoned
U.S.S.N. 16/440,261
Filed 6/13/2019
51169-008003
CAD-013US2
Published
AU 2016212025
51169-008AU2
CAD-013AU
Published
BR 1120170159465
51169-008BR2
CAD-013BR
Published
CA 2,975,091
51169-008CA2
CAD-013CA
Published
CN 201680016821.1
51169-008CN2
CAD-013CN
Published
EP 16743841.5
51169-008EP2
CAD-013EP
Published
HK 18106258.4
51169-008HK2
CAD-013HK
Pending
ID PID201705111
51169-008ID2
CAD-013ID
Pending
IN 201717028052
51169-008IN2
CAD-013IN
Published
JP 2017-557270
51169-008JP2
CAD-013JP
Published
MX/a/2017/009722
51169-008MX2
CAD-013MX
Published
MY PI 2017001086
51169-008MY2
CAD-013MY
Pending
PH 1-2017-501341
51169-008PH2
CAD-013PH
Published
RU 2017130166
51169-008RU2
CAD-013RU
Pending
ZA 2017/05200
51169-008ZA2
CAD-013ZA
Pending
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
Title/Inventors
Pub. No.
Serial No.
C & E Ref.
Cadena Ref.
Status
Patent No. /
Issue date
6
OLIGOSACCHARIDE COMPOSITIONS
FOR USE IN NUTRITIONAL
COMPOSITIONS, AND METHODS OF
PRODUCING THEREOF
John M. Geremia
Corresponding to International
Application PCT/US2016/013271
Filed January 13, 2016
Priority information: 62/108,038
filed 1/26/2015
U.S.S.N 15/546,508
Filed 07/26/2017
51169-010002
CAD-015US
Published
AU 2016212026
51169-010AU2
CAD-015AU
Published
CA 2,975,093
51169-010CA2
CAD-015CA
Published
CN 201680016981.6
51169-010CN2
CAD-015CN
Published
EP 16743842.3
51169-010EP2
CAD-015EP
Published
HK 18106257.5
51169-010HK2
CAD-015HK
Pending
JP 2017-557271
51169-010JP2
CAD-015JP
Published
MX/a/2017/009720
51169-010MX2
CAD-015MX
Published
7#
OLIGOSACCHARIDE COMPOSITIONS
FOR USE AS ANIMAL FEED AND
METHODS OF PRODUCING THEREOF
John M. Geremia Raffi
Mardirosian Michael J.
Gidding Anastasia V. Murphy
Corresponding to
PCT/US2016/013280
Filed 1/13/2016
Priority information: 62/108,037
filed 1/26/2015
62/216,945 filed 9/10/2015
62/216,952 filed 9/10/2015
U.S.S.N. 14/995,129*
Filed 1/13/2016
51169-017001
CAD-014 US
Pending
BR 1120170159449
51169-017BR1
CAD-014BR
Published
CA 2,975,095
51169-017CA1
CAD-014CA
Published
CN 201680016822.6
51169-017CN1
CAD-014CN
Published
EP 16743843.1
51169-017EP1
CAD-014EP
Granted
EP 3250048
08/14/2019
EP 19191223.7
51169-017EP2
CAD-014EP1
Pending
HK 18106256.6
51169-017HK1
CAD-014HK
Pending
IN 201717026993
51169-017IN1
CAD-014IN
Published
JP 2017-557272
51169-017JP1
CAD-014JP
Published
MX/a/2017/009730
51169-017MX1
CAD-014MX
Published
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
Title/Inventors
Pub. No.
Serial No.
C & E Ref.
Cadena Ref.
Status
Patent No. /
Issue date
62/255,341 filed 11/13/2015
62/255,343 filed 11/13/2015
8#
ANIMAL THERAPEUTIC AND FEED
COMPOSITIONS AND METHODS OF
USE
John M. Geremia Anastasia V.
Murphy
Priority information: 62/255,348 filed
11/13/2015
62/255,352 filed 11/13/2015
PCT/US2016/061337
Filed 11/10/2016
51169-020WO1
CAD-020 WO
National
Stage
U.S.S.N. 15/775,501
Filed 05/11/2018
51169-020001
CAD-020 US
Abandoned
U.S.S.N. 16/293,140 Filed
03/05/2019
51169-020002
CAD-020 US1
Pending
* US Utility application, not a national phase. # Exclusively
licensed to Midori, Inc.
b)
Trademarks and/or service marks: None
c)
Copyright registrations or applications: None
d)
Domain names: None
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
EXHIBIT D
BORROWER’S DEPOSIT ACCOUNTS AND INVESTMENT ACCOUNTS
[***]
1 NTD: This balance is as of November 30th. Kaleido will not be making future deposits to this PacWest account. The plan is to transfer the balance
(net of any remaining outstanding checks, currently ~$0.010M) to the JPM operating account by the end of December, 2019.
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
EXHIBIT E COMPLIANCE
CERTIFICATE
Hercules Capital, Inc. (as “Agent”) 400 Hamilton
Avenue, Suite 310 Palo Alto, CA 94301
Reference is made to that certain Loan and Security Agreement dated as of December 31, 2019 and the Loan Documents
(as defined therein) entered into in connection with such Loan and Security Agreement all as may be amended from time to time
(hereinafter referred to collectively as the “Loan Agreement”) by and among Hercules Capital, Inc. (the “Agent”), the several
banks and other financial institutions or entities from time to time party thereto (collectively, the “Lender”) and Kaleido
Biosciences, Inc. (the “Company”) and each of its Qualified Subsidiaries, as Borrower. All capitalized terms not defined herein
shall have the same meaning as defined in the Loan Agreement.
The undersigned is an Officer of the Company, knowledgeable of all Company financial matters, and is authorized to
provide certification of information regarding the Company; hereby certifies, in such capacity and not in his individual capacity, that
in accordance with the terms and conditions of the Loan Agreement, the Company is in compliance for the period ending
of all
covenants, conditions and terms and hereby reaffirms that all representations and warranties contained therein are true and correct in
all material respects (to the extent not already qualified by materiality) on and as of the date of this Compliance Certificate with the
same effect as though made on and as of such date, except to the extent such representations and warranties expressly relate to an
earlier date, after giving effect in all cases to any standard(s) of materiality contained in the Loan Agreement as to such
representations and warranties. Attached are the required documents supporting the above certification. The undersigned further
certifies that the attached financial statements are prepared in accordance with GAAP (except for the absence of footnotes with
respect to unaudited financial statement and subject to normal year-end adjustments) and are consistent from one period to the next
except as explained below.
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
REPORTING REQUIREMENT REQUIRED
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
CHECK IF ATTACHED
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
Interim Financial Statements Monthly within 30 days
Interim Financial Statements Quarterly within 45 days
Audited Financial Statements FYE within 90 days
ACCOUNTS OF BORROWER AND ITS SUBSIDIARIES AND AFFILIATES
The undersigned hereby also confirms the below disclosed accounts represent all depository accounts and securities accounts
presently open in the name of each Borrower or Borrower’s Subsidiary, as applicable.
Each new account that has been opened since delivery of the previous Compliance Certificate is designated below with a
“*”.
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
Depository AC #
Financial
Institution
Account Type
(Depository /
Securities)
Last
Month
Ending
Account
Balance
Purpose of
Account
BORROWER
Name/Address:
1
2
3
4
5
6
7
BORROWER’S
SUBSIDIARY
Name/Address
1
2
3
4
5
6
7
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
Very Truly Yours,
KALEIDO BIOSCIENCES, INC.
By:
Name:
Its:
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
EXHIBIT F
FORM OF JOINDER AGREEMENT
This Joinder Agreement (the “Joinder Agreement”) is made and dated as of [
], 20[ ], and is entered into by and between
., a corporation (“Subsidiary”), and HERCULES CAPITAL, INC., a Maryland corporation (as “Agent”).
RECITALS
A.
Subsidiary’s Affiliate, [ ] (“Company”) [has entered/desires to enter] into that certain Loan and Security
Agreement dated as of December 31, 2019, with the several banks and other financial institutions or entities from time to time party
thereto as lender (collectively, the “Lenders”) and the Agent, as such agreement may be amended, restated, supplemented or otherwise
modified (the “Loan Agreement”), together with the other agreements executed and delivered in connection therewith;
B.
Subsidiary acknowledges and agrees that it will benefit both directly and indirectly from Company’s
execution of the Loan Agreement and the other agreements executed and delivered in connection therewith;
AGREEMENT
NOW THEREFORE, Subsidiary and Agent agree as follows:
1.
The recitals set forth above are incorporated into and made part of this Joinder Agreement. Capitalized terms not defined
herein shall have the meaning provided in the Loan Agreement.
2.
By signing this Joinder Agreement, Subsidiary shall be bound by the terms and conditions of the Loan Agreement the
same as if it were the Borrower (as defined in the Loan Agreement) under the Loan Agreement, mutatis mutandis, provided
however, that (a) with respect to (i) Section 5.1 of the Loan Agreement, Subsidiary represents that it is an entity duly
organized, legally existing and in good standing under the laws of [ ], (b) neither Agent nor the Lenders shall have any
duties, responsibilities or obligations to Subsidiary arising under or related to the Loan Agreement or the other Loan
Documents, (c) that if Subsidiary is covered by Company’s insurance, Subsidiary shall not be required to maintain separate
insurance or comply with the provisions of Sections 6.1 and 6.2 of the Loan Agreement, and (d) that as long as Company
satisfies the requirements of Section 7.1 of the Loan Agreement, Subsidiary shall not have to provide Agent separate
Financial Statements. To the extent that Agent or the Lenders has any duties, responsibilities or obligations arising under or
related to the Loan Agreement or the other Loan Documents, those duties, responsibilities or obligations shall flow only to
Company and not to Subsidiary or any other Person or entity. By way of example (and not an exclusive list): (i) Agent’s
providing notice to Company in accordance with the Loan Agreement or as otherwise agreed among Company, Agent and
the Lenders shall be deemed provided to Subsidiary; (ii) a Lender’s providing an Advance to Company shall be deemed an
Advance to Subsidiary; and (iii) Subsidiary shall have no right to request an Advance or make any other demand on the
Lenders.
3.
Subsidiary agrees not to certificate its equity securities without Agent’s prior written consent, which consent may be
conditioned on the delivery of such equity securities to Agent in order to perfect Agent’s security interest in such equity
securities.
4.
Subsidiary acknowledges that it benefits, both directly and indirectly, from the Loan Agreement, and hereby waives, for itself
and on behalf on any and all successors in interest (including without
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
limitation any assignee for the benefit of creditors, receiver, bankruptcy trustee or itself as debtor- in-possession under any
bankruptcy proceeding) to the fullest extent provided by law, any and all claims, rights or defenses to the enforcement of this
Joinder Agreement on the basis that (a) it failed to receive adequate consideration for the execution and delivery of this
Joinder Agreement or (b) its obligations under this Joinder Agreement are avoidable as a fraudulent conveyance.
5.
As security for the prompt, complete and indefeasible payment when due (whether on the payment dates or otherwise) of all
the Secured Obligations, Subsidiary grants to Agent a security interest in all of Subsidiary’s right, title, and interest in and to
the Collateral.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
[SIGNATURE PAGE TO JOINDER AGREEMENT]
SUBSIDIARY:
.
By:
Name:
Title:
Address:
Telephone:
email:
AGENT:
HERCULES CAPITAL, INC.
By:
Name:
Title:
Address:
400 Hamilton Ave., Suite 310 Palo Alto, CA
94301
email: legal@htgc.com Telephone: 650-
289-3060
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
EXHIBIT G
ACH DEBIT AUTHORIZATION AGREEMENT
Hercules Capital, Inc.
400 Hamilton Avenue, Suite 310 Palo Alto, CA
94301
Re: Loan and Security Agreement dated as of December 31, 2019 (the “Agreement”) by and among Kaleido Biosciences,
Inc. and each of its Qualified Subsidiaries (collectively, “Borrower”) and Hercules Capital, Inc., as agent (“Agent”) and the
Lenders party thereto (collectively, the “Lenders”)
In connection with the above referenced Agreement, the Borrower hereby authorizes the Agent to initiate debit entries for (i) the
periodic payments due under the Agreement and (ii) reasonable and documented out-of-pocket legal fees and costs incurred by Agent
or the Lenders pursuant to Section 11.12 of the Agreement to the Borrower’s account indicated below; provided, however, that Agent
shall provide Borrower with an invoice of such fees and costs. The Borrower authorizes the depository institution named below to
debit to such account.
[IF FILED PUBLICLY, ACCOUNT INFO REDACTED FOR SECURITY PURPOSES]
DEPOSITORY NAME
BRANCH
CITY
STATE AND ZIP CODE
TRANSIT/ABA NUMBER
ACCOUNT NUMBER
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
This authority will remain in full force and effect so long as any amounts are due under the Agreement. KALEIDO
BIOSCIENCES, INC.
By:
Name:
Date:
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
EXHIBIT H-1
FORM OF U.S. TAX COMPLIANCE CERTIFICATE
(For Foreign Lenders That Are Not Partnerships For U.S. Federal Income Tax Purposes)
Reference is hereby made to the Loan and Security Agreement dated as of December 31, 2019 (as amended, supplemented
or otherwise modified from time to time, the “Loan Agreement”) by and among Kaleido Biosciences, Inc., a Delaware corporation,
and each of its Qualified Subsidiaries (as defined in the Loan Agreement) (hereinafter collectively referred to as the “Borrower”), the
several banks and other financial institutions or entities from time to time parties to the Loan Agreement (collectively, referred to as
the “Lenders”), and Hercules Capital, Inc., a Maryland corporation, in its capacity as administrative agent and collateral agent for
itself and the Lenders (in such capacity, the “Agent”).
Pursuant to the provisions of Addendum 1 of the Loan Agreement, the undersigned hereby certifies that (i) it is the sole
record and beneficial owner of the Loan(s) (as well as any promissory note(s) evidencing such Loan(s)) in respect of which it is
providing this certificate, (ii) it is not a “bank” within the meaning of Section 881(c)(3)(A) of the Code, (iii) it is not a “ten percent
shareholder” of the Borrower within the meaning of Section 871(h)(3)(B) of the Code and (iv) it is not a “controlled foreign
corporation” related to the Borrower as described in Section 881(c)(3)(C) of the Code.
The undersigned has furnished the Agent and the Borrower with a certificate of its non-U.S. Person status on IRS Form W-
8BEN or IRS Form W-8BEN-E. By executing this certificate, the undersigned agrees that (1) if the information provided in this
certificate changes, or if a lapse in time or change in circumstances renders the information in this certificate obsolete, expired or
inaccurate in any material respect, the undersigned shall promptly so inform the Borrower and the Agent in writing and deliver
promptly to the Agent and the Borrower an updated certificate or other appropriate documentation (including any new documentation
reasonably requested by the Agent or the Borrower) or promptly notify the Agent and the Borrower in writing of its legal ineligibility
to do so, and (2) the undersigned shall have at all times furnished the Borrower and the Agent with a properly completed and
currently effective certificate in either the calendar year in which each payment is to be made to the undersigned, or in either of the
two calendar years preceding such payments.
Unless otherwise defined herein, terms defined in the Loan Agreement and used herein shall have the meanings given to
them in the Loan Agreement.
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
Date:
, 20
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
[NAME OF LENDER]
By:
Name:
Title:
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
EXHIBIT H-2
FORM OF U.S. TAX COMPLIANCE CERTIFICATE
(For Foreign Participants That Are Not Partnerships For U.S. Federal Income Tax Purposes)
Reference is hereby made to the Loan and Security Agreement dated as of December 31, 2019 (as amended, supplemented
or otherwise modified from time to time, the “Loan Agreement”) by and among Kaleido Biosciences, Inc., a Delaware corporation,
and each of its Qualified Subsidiaries (as defined in the Loan Agreement) (hereinafter collectively referred to as the “Borrower”), the
several banks and other financial institutions or entities from time to time parties to the Loan Agreement (collectively, referred to as
the “Lenders”), and Hercules Capital, Inc., a Maryland corporation, in its capacity as administrative agent and collateral agent for
itself and the Lenders (in such capacity, the “Agent”).
Pursuant to the provisions of Addendum 1 of the Loan Agreement, the undersigned hereby certifies that (i) it is the sole
record and beneficial owner of the participation in respect of which it is providing this certificate, (ii) it is not a “bank” within the
meaning of Section 881(c)(3)(A) of the Code,
(iii) it is not a “ten percent shareholder” of the Borrower within the meaning of Section 871(h)(3)(B) of the Code and (iv) it is not a
“controlled foreign corporation” related to the Borrower as described in Section 881(c)(3)(C) of the Code.
The undersigned has furnished its participating Lender with a certificate of its non-U.S. Person status on IRS Form W-
8BEN or IRS Form W-8BEN-E. By executing this certificate, the undersigned agrees that (1) if the information provided in this
certificate changes, or if a lapse in time or change in circumstances renders the information in this certificate obsolete, expired or
inaccurate in any material respect, the undersigned shall promptly so inform such Lender in writing and deliver promptly to such
Lender an updated certificate or other appropriate documentation (including any new documentation reasonably requested by such
Lender) or promptly notify such Lender in writing of its legal ineligibility to do so, and (2) the undersigned shall have at all times
furnished such Lender with a properly completed and currently effective certificate in either the calendar year in which each payment
is to be made to the undersigned, or in either of the two calendar years preceding such payments.
Unless otherwise defined herein, terms defined in the Loan Agreement and used herein shall have the meanings given to
them in the Loan Agreement.
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
Date:
, 20
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
[NAME OF PARTICIPANT]
By:
Name:
Title:
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
EXHIBIT H-3
FORM OF U.S. TAX COMPLIANCE CERTIFICATE
(For Foreign Participants That Are Partnerships For U.S. Federal Income Tax Purposes)
Reference is hereby made to the Loan and Security Agreement dated as of December 31, 2019 (as amended, supplemented
or otherwise modified from time to time, the “Loan Agreement”) by and among Kaleido Biosciences, Inc., a Delaware corporation,
and each of its Qualified Subsidiaries (as defined in the Loan Agreement) (hereinafter collectively referred to as the “Borrower”), the
several banks and other financial institutions or entities from time to time parties to the Loan Agreement (collectively, referred to as
the “Lenders”), and Hercules Capital, Inc., a Maryland corporation, in its capacity as administrative agent and collateral agent for
itself and the Lenders (in such capacity, the “Agent”).
Pursuant to the provisions of Addendum 1 of the Loan Agreement, the undersigned hereby certifies that (i) it is the sole
record owner of the participation in respect of which it is providing this certificate, (ii) its direct or indirect partners/members are the
sole beneficial owners of such participation,
(iii) with respect to such participation, neither the undersigned nor any of its direct or indirect partners/members is a “bank” extending
credit pursuant to a loan agreement entered into in the ordinary course of its trade or business within the meaning of Section 881(c)(3)
(A) of the Code, (iv) none of its direct or indirect partners/members is a “ten percent shareholder” of the Borrower within the
meaning of Section 871(h)(3)(B) of the Code and (v) none of its direct or indirect partners/members is a “controlled foreign
corporation” related to the Borrower as described in Section 881(c)(3)(C) of the Code.
The undersigned has furnished its participating Lender with IRS Form W-8IMY accompanied by one of the following forms
from each of its partners/members that is claiming the portfolio interest exemption: (i) an IRS Form W-8BEN or IRS Form W-8BEN-
E or (ii) an IRS Form W-8IMY accompanied by an IRS Form W-8BEN or IRS Form W-8BEN-E from each of such
partner’s/member’s beneficial owners that is claiming the portfolio interest exemption. By executing this certificate, the undersigned
agrees that (1) if the information provided in this certificate changes, or if a lapse in time or change in circumstances renders the
information in this certificate obsolete, expired or inaccurate in any material respect, the undersigned shall promptly so inform such
Lender in writing and deliver promptly to such Lender an updated certificate or other appropriate documentation (including any new
documentation reasonably requested by the Borrower or the Agent) or promptly notify such Lender in writing of its legal ineligibility
to do so, and (2) the undersigned shall have at all times furnished such Lender with a properly completed and currently effective
certificate in either the calendar year in which each payment is to be made to the undersigned, or in either of the two calendar years
preceding such payments.
Unless otherwise defined herein, terms defined in the Loan Agreement and used herein shall have the meanings given to
them in the Loan Agreement.
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
Date:
, 20
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
[NAME OF PARTICIPANT]
By:
Name:
Title:
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
EXHIBIT H-4
FORM OF U.S. TAX COMPLIANCE CERTIFICATE
(For Foreign Lenders That Are Partnerships For U.S. Federal Income Tax Purposes)
Reference is hereby made to the Loan and Security Agreement dated as of December 31, 2019 (as amended, supplemented
or otherwise modified from time to time, the “Loan Agreement”) by and among Kaleido Biosciences, Inc., a Delaware corporation,
and each of its Qualified Subsidiaries (as defined in the Loan Agreement) (hereinafter collectively referred to as the “Borrower”), the
several banks and other financial institutions or entities from time to time parties to the Loan Agreement (collectively, referred to as
the “Lenders”), and Hercules Capital, Inc., a Maryland corporation, in its capacity as administrative agent and collateral agent for
itself and the Lenders (in such capacity, the “Agent”).
Pursuant to the provisions of Addendum 1 of the Loan Agreement, the undersigned hereby certifies that (i) it is the sole
record owner of the Loan(s) (as well as any promissory note(s) evidencing such Loan(s)) in respect of which it is providing this
certificate, (ii) its direct or indirect partners/members are the sole beneficial owners of such Loan(s) (as well as any promissory note(s)
evidencing such Loan(s)),
(iii) with respect to the extension of credit pursuant to this Loan Agreement or any other Loan Document, neither the undersigned nor
any of its direct or indirect partners/members is a “bank” extending credit pursuant to a loan agreement entered into in the ordinary
course of its trade or business within the meaning of Section 881(c)(3)(A) of the Code, (iv) none of its direct or indirect
partners/members is a “ten percent shareholder” of the Borrower within the meaning of Section 871(h)(3)(B) of the Code and (v)
none of its direct or indirect partners/members is a “controlled foreign corporation” related to the Borrower as described in Section
881(c)(3)(C) of the Code.
The undersigned has furnished the Agent and the Borrower with IRS Form W-8IMY accompanied by one of the following
forms from each of its partners/members that is claiming the portfolio interest exemption: (i) an IRS Form W-8BEN or IRS Form W-
8BEN-E or (ii) an IRS Form W-8IMY accompanied by an IRS Form W-8BEN or IRS Form W-8BEN-E from each of such
partner’s/member’s beneficial owners that is claiming the portfolio interest exemption. By executing this certificate, the undersigned
agrees that (1) if the information provided in this certificate changes, or if a lapse in time or change in circumstances renders the
information in this certificate obsolete, expired or inaccurate in any material respect, the undersigned shall promptly so inform the
Borrower and the Agent in writing and deliver promptly to the Borrower and the Agent an updated certificate or other appropriate
documentation (including any new documentation reasonably requested by the Borrower or the Agent) or promptly notify the
Borrower and the Agent in writing of its legal ineligibility to do so, and (2) the undersigned shall have at all times furnished the
Borrower and the Agent with a properly completed and currently effective certificate in either the calendar year in which each
payment is to be made to the undersigned, or in either of the two calendar years preceding such payments.
Unless otherwise defined herein, terms defined in the Loan Agreement and used herein shall have the meanings given to
them in the Loan Agreement.
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
Date:
, 20
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
[NAME OF LENDER]
By:
Name:
Title:
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
SCHEDULE 1.1
COMMITMENTS
LENDER
TRANCHE
TERM COMMITMENT
Hercules Funding IV LLC
Tranche 1
$22,500,000
Hercules Capital, Inc.
Tranche 2
$5,000,000*
Hercules Capital, Inc.
Tranche 3
$12,500,000*
[Hercules Capital, Inc.]
Tranche 4
$1,700,000
TOTAL COMMITMENTS
$41,700,000.00
* Expired unfunded.
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
SCHEDULE 1
SUBSIDIARIES
1. Cadena Bio, Inc.
2. Kaleido Biosciences Securities Corporation
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
SCHEDULE 1A
EXISTING PERMITTED INDEBTEDNESS
Agreement
Date
Description of Indebtedness
Letter of Credit
September 24, 2019, as may be
replaced to reflect correction of
proper beneficiary (subject to the
limitations set forth in clause
(viii)
of
the
definition
of
Permitted Indebtedness)
Letter of Credit with Square 1 Bank
issued in connection with the security
deposit requirement under the lease for
space at 18 Crosby Drive, Bedford MA
in the amount of $117,156.33
Letter of Credit
December 16, 2019
Letter of Credit with JPMorgan Chase
Bank, N.A. issued in connection with
the security deposit requirement under
the lease for space at 65 Hayden Street,
Lexington MA in the amount of
$2,057,658.75
Line of Credit
Kaleido’s American Express
account went effective on
October 1, 2018.
Line of Credit with American Express
issued in connection with the Company’s
corporate credit card program in the
amount of $1,000,000.00; provided that
the amount of any thereunder
Indebtedness, together with any other
credit card Indebtedness, shall not exceed
the cap set forth in clause
(iv) of the definition of
Permitted Indebtedness
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
SCHEDULE 1B
EXISTING PERMITTED INVESTMENTS
Investments held by Kaleido Biosciences, Inc. of 1,000 shares of common stock of Cadena Bio, Inc., par value $0.001.
Investments held by Kaleido Biosciences, Inc. of 1,000 shares of common stock of Kaleido Biosciences Securities Corporation, par value
$0.001.
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
SCHEDULE 1C EXISTING PERMITTED LIENS
Name of Holder of
Lien/Encumbrance
Description of Property
Encumbered
Company/Subsidiary
De Lage Landen Financial
Services, Inc.
Lien of De Lage Landen Financial
Services, Inc. on a leased asset of Kaleido
Biosciences, Inc.
Kaleido Biosciences, Inc.
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
SCHEDULE 5.3
CONSENTS, ETC.
None.
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
SCHEDULE 5.8
TAX MATTERS
None.
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
SCHEDULE 5.9
INTELLECTUAL PROPERTY CLAIMS
None.
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
SCHEDULE 5.10
INTELLECTUAL PROPERTY
None.
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
SCHEDULE 5.11
BORROWER PRODUCTS
None.
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
SCHEDULE 5.14
CAPITALIZATION
(See Attached)
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693242.5
SCHEDULE 7.12
DEPOSIT ACCOUNTS
[****]
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693051.4
ANNEX B
[***]
US-DOCS\130693051.4
ACTIVE/116115708.1
US-DOCS\130693051.4
Exhibit 23.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the incorporation by reference in Registration Statements Nos. 333-240323 and 333-236804 each on Form S-3 and Registration Statement
Nos. 333-255773, 333-238123 and 333-230167 each on Form S-8 of our report dated March 31, 2022, relating to the financial statements of Kaleido
Biosciences, Inc. appearing in this Annual Report on Form 10-K for the year ended December 31, 2021.
/s/ Deloitte & Touche LLP
Boston, Massachusetts
March 31, 2022
Exhibit 31.1
CERTIFICATION PURSUANT TO RULE 13a-14(a) OR 15d-14(a)
OF THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF
THE SARBANES-OXLEY ACT OF 2002
I, Daniel L. Menichella, certify that:
1.
I have reviewed this annual report on Form 10-K of Kaleido Biosciences, Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements
made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial
condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act
Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f)and 15d-15(f)) for the registrant and
have:
a.
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure
that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities,
particularly during the period in which this report is being prepared;
b.
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision,
to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in
accordance with generally accepted accounting principles;
c.
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness
of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal
quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect,
the registrant’s internal control over financial reporting.
5.
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a.
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely
to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b.
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over
financial reporting.
Date: March 31, 2022
By:
/s/ Daniel L. Menichella
Daniel L. Menichella
Chief Executive Officer, President and Director
(Principal Executive Officer)
Exhibit 31.2
CERTIFICATION PURSUANT TO RULE 13a-14(a) OR 15d-14(a)
OF THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF
THE SARBANES-OXLEY ACT OF 2002
I, William Duke, Jr., certify that:
1.
I have reviewed this annual report on Form 10-K of Kaleido Biosciences, Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements
made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial
condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act
Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f)and 15d-15(f)) for the registrant and
have:
a.
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure
that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities,
particularly during the period in which this report is being prepared;
b.
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision,
to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in
accordance with generally accepted accounting principles;
c.
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness
of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal
quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect,
the registrant’s internal control over financial reporting.
5.
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a.
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely
to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b.
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over
financial reporting.
Date: March 31, 2022
By:
/s/ William Duke, Jr.
William Duke, Jr.
Chief Financial Officer
(Principal Financial Officer)
Exhibit 32.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER
PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
I, Daniel L. Menichella, Chief Executive Officer of Kaleido Biosciences, Inc. (the “Company”), do hereby certify, pursuant to Rule 13a-14(b) or Rule 15d-
14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350, that, to the best of my knowledge:
(1) the Annual Report on Form 10-K of the Company for the year ended December 31, 2021 (the “Report”) fully complies with the requirements of Section
13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Dated: March 31, 2022
/s/ Daniel L. Menichella
Daniel L. Menichella
Chief Executive Officer
(Principal Executive Officer)
Exhibit 32.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER
PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
I, William Duke, Jr., Chief Financial Officer of Kaleido Biosciences, Inc. (the “Company”), do hereby certify, pursuant to Rule 13a-14(b) or Rule 15d-
14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350, that, to the best of my knowledge:
(1) the Annual Report on Form 10-K of the Company for the year ended December 31, 2021 (the “Report”) fully complies with the requirements of Section
13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Dated: March 31, 2022
/s/ William Duke, Jr.
William Duke, Jr.
Chief Financial Officer
(Chief Financial Officer)