UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K
(Mark One)
☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2017
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: 000-55334
COHBAR, INC.
(Exact name of Registrant as specified in its charter)
Delaware
(State or other jurisdiction of
incorporation or organization)
26-1299952
(I.R.S. Employer
Identification No.)
1455 Adams Drive, Suite 2050
Menlo Park, CA 94025
(Address of principal executive offices, including zip code)
(650) 446-7888
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
None
Securities registered pursuant to Section 12(g) of the Act:
Common Stock
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 and posted on its corporate Web site, if any, every Interactive
Data File required to be submitted and posted 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 and post such files). Yes ☒ No ☐
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be
contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this
Form 10-K or any amendment to this Form 10-K. ☒
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 the 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 ☐
Non-accelerated filer ☐ (Do not check if smaller reporting company)
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 to Section 7(a)(2)(B) of the Securities Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒
The aggregate market value of common equity held by non-affiliates as of June 30, 2017 was $34,561,491, based upon the closing price of
the Registrant's common stock as quoted in OTCQX Marketplace on such date. As of March 28, 2018, the registrant had outstanding
39,956,147 shares of common stock.
The registrant has incorporated by reference into Part III of this Form 10-K portions of its Proxy Statement for its 2017 Annual Meeting of
Shareholders.
Documents Incorporated by Reference
Business
Item 1.
Item 1A. Risk Factors
Item 1B. Unresolved Staff Comments
Item 2.
Item 3.
Item 4. Mine Safety Disclosures
Properties
Legal Proceedings
COHBAR, INC.
2017 FORM 10-K ANNUAL REPORT
Table of Contents
PART I
PART II
Selected Financial Data
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Item 6.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Item 7A. Quantitative and Qualitative Disclosures about Market Risk
Item 8.
Item 9.
Item 9A. Controls and Procedures
Item 9B. Other Information
Financial Statements
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
PART III
Item 10. Directors, Executive Officers and Corporate Governance
Item 11.
Item 12.
Item 13. Certain Relationships and Related Transactions, and Director Independence
Item 14.
Executive Compensation
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Principal Accounting Fees and Services
Item 15.
Item 16.
Exhibits and Financial Statement Schedules
Form 10-K Summary
Signatures
PART IV
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Forward-Looking Statements
PART I
This report, including the “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” contains
forward-looking statements regarding future events and our future results that are based on our current expectations, estimates, forecasts,
and projections about our business, our results of operations, the industry in which we operate and the beliefs and assumptions of our
management. Words such as “may”, “will”, “should”, “could”, “anticipate”, “believe”, “expect”, “intend”, “plan”, “potential”, “continue”
and similar expressions are intended to identify these forward-looking statements. Examples of such forward-looking statements include:
● statements regarding anticipated outcomes of our research into mitochondrial-derived peptides (MDPs), and pre-clinical and
clinical trials for our mitochondria based therapeutics (MBTs);
● expectations regarding the future market for any drug we may develop;
● statements regarding the anticipated therapeutic properties of our MBT drug development candidates;
● expectations regarding our ability to effectively protect our intellectual property; and
● expectations regarding our ability to attract and retain qualified employees and key personnel.
These statements reflect our current beliefs and are based on information currently available to us. Forward-looking statements
involve significant risks and uncertainties, including without limitation, those listed in the “Risk Factors” section. A number of factors
could cause actual results to differ materially from the results discussed in the forward-looking statements including, but not limited to,
changes in general economic and market conditions and the risk factors disclosed under “Risk Factors”. Although the forward-looking
statements contained in this report are based upon what we believe to be reasonable assumptions, we cannot assure you that actual results
will be consistent with these forward-looking statements. Investors should not place undue reliance on forward-looking statements. These
forward-looking statements are made as of the date hereof and we assume no obligation to update or revise them to reflect new events or
circumstances, except as required by applicable law.
Item 1. Business
OVERVIEW
CohBar, Inc. (“CohBar,” “we,” “us,” “our,” “its” or the “Company”) is an innovative biotechnology company and a leader in the
research and development of mitochondria based therapeutics (MBTs), an emerging class of drugs which may provide treatments for a wide
range of diseases associated with aging and metabolic dysfunction, including non-alcoholic steatohepatitis (NASH), obesity, type 2
diabetes mellitus (T2D), cancer, atherosclerosis, cardiovascular disease and neurodegenerative diseases such as Alzheimer’s disease.
MBTs originate from almost two decades of research by our founders, resulting in their discovery of a novel group of
mitochondrial-derived peptides (MDPs) encoded within the mitochondrial genome. Some of these naturally occurring MDPs and their
analogs have demonstrated a range of biological activity and therapeutic potential in pre-clinical models across multiple diseases associated
with aging.
We believe CohBar is the first mover in exploring the mitochondrial genome for therapeutically relevant peptides, and has
developed a proprietary MBT technology platform, using cell-based assays and animal models of disease, to rapidly identify naturally
occurring MDPs with promising biological activity. Once identified, we deploy optimization techniques to improve the drug-like properties
of our MBT candidates, enabling us to match the most biologically promising peptides to disease indications that have substantial unmet
medical needs.
1
In September 2016, we advanced two novel, optimized analogs of our MOTS-c MDP, CB4209 and CB4211, into IND-enabling
studies as our lead MBT candidates for the potential treatment of NASH and obesity. In November 2017 we announced the selection of
CB4211 as the final candidate for the remaining pre-IND studies, with initiation of a first-in-human Phase 1a/b clinical trial targeted for
mid-2018, followed by an activity readout relevant to NASH and obesity projected in early 2019.
In addition to the original discovery by our founders of MOTS-c and other CohBar licensed peptides, CohBar’s scientific team
have more recently discovered and filed more than 65 provisional patent applications that cover over 100 additional MDPs that have
demonstrated a range of biological activities and therapeutic potential. Our ongoing research and development activities focus on
identifying and advancing novel improved MDP analogs that have the greatest therapeutic and commercial potential for development into
drugs.
Our scientific team includes the expertise of our founders, Dr. Pinchas Cohen, Dean of the Davis School of Gerontology at the
University of Southern California, and Dr. Nir Barzilai, Professor of Medicine and Genetics and Director of the Institute for Aging
Research at the Albert Einstein College of Medicine, and is augmented by our co-founders, Dr. David Sinclair, Professor of Genetics at
Harvard Medical School, and Dr. John Amatruda, former Senior Vice President and Franchise Head for Diabetes and Obesity at Merck
Research Laboratories. Our research and development efforts are conducted under the leadership of our Chief Scientific Officer, Dr.
Kenneth Cundy, former Chief Scientific Officer at Xenoport, Inc. and Senior Director of Biopharmaceutics at Gilead Sciences, Inc. Dr.
Cundy is the co-inventor of several approved drugs including tenofovir, an antiretroviral drug that is marketed globally in various
combinations with other drugs for the treatment of HIV infection (Atripla®, Viread®, Complera®, Stribild®, Truvada®), gabapentin
enacarbil (Horizant®) for the treatment of RLS and post-herpetic neuralgia, and Nanocrystal® technology, employed in several other
approved drugs.
We are the exclusive licensee from the Regents of the University of California and the Albert Einstein College of Medicine of
four issued U.S. patents, four U.S. patent applications and several related international patent applications in various jurisdictions. Our
licensed patents and patent applications include claims that are directed to compositions comprising MDPs and their analogs and/or
methods of their use in the treatment of indicated diseases. We have also filed a non-provisional patent application under the international
patent cooperation treaty (PCT) and more than 65 provisional patent applications with claims directed to both compositions comprising and
methods of using novel proprietary MDPs and their analogs.
We believe that the proprietary capabilities of our technology platform combined with our scientific expertise and intellectual
property portfolio provides a competitive advantage in our mission to treat age-related diseases and extend healthy life spans through the
advancement of MBTs as a new class of transformative drugs.
We were formed as a limited liability company in the state of Delaware in 2007, and converted to a Delaware corporation in 2009.
We completed our initial public offering of common stock in January 2015 and our common stock is listed for trading on the Nasdaq
Capital Market (CWBR) and the TSX-V (COB.U).
Our corporate headquarters and laboratory are located in Menlo Park, California.
2
BUSINESS STRATEGY
Our strategic objective is to secure, maintain and exploit a leading scientific, commercial and intellectual property position in the
arena of mitochondria based therapeutics, with best-in-class treatments for diseases associated with aging and metabolic dysfunction. The
key elements of our strategy include:
● Advancing CB4211 through clinical trials;
● utilizing our proprietary technology platform to continue identifying, assessing and optimizing new analogs of biologically
active MDPs and advancing research and development on those MBT candidates with the greatest therapeutic and commercial
potential;
● developing strategic partnerships with leading pharmaceutical companies and other organizations to advance our research
programs and future development and commercialization efforts;
● raising capital to fund our operations, research and clinical development programs;
● minimizing operating costs and related funding requirements for our research and development activities through careful
program management and cost-efficient relationships with academic partners, consultants and contract research organizations
(CROs);
● continuing to optimize our intellectual property portfolio to capture all novel therapeutically relevant peptides encoded within
the mitochondrial genome; and
● increasing awareness and recognition of our team, assets, capabilities and opportunities within the investment and scientific
communities.
OUR PIPELINE
Our pipeline includes a number of MDPs and MBT candidates in different stages of pre-clinical study. Our research efforts are
focused on identifying, assessing and optimizing new analogs of biologically active MDPs and advancing those candidates with the greatest
therapeutic and commercial potential.
CB4211
In September 2016, we advanced two novel, optimized analogs of our MOTS-c MDP, CB4209 and CB4211, into IND-enabling
studies as our lead MBT candidates with potential for treatment of NASH and obesity. In November 2017 we announced the selection of
CB4211 as the final candidate for the remaining pre-IND studies. CB4211 is currently advancing towards the initiation of a first-in-human
Phase 1a/b clinical trial targeted for mid-2018 that is expected to provide an activity readout relevant to NASH and obesity projected in
early 2019.
CB4211 is a novel, optimized analog of MOTS-c, a naturally occurring mitochondrial peptide discovered by our founders and
their academic collaborators in 2012. Their research in cell-based assays and animal models indicated that MOTS-c plays a significant role
in the regulation of metabolism. Certain of the original MOTS-c studies were published in an article entitled “The Mitochondrial-Derived
Peptide, MOTS-c, Promotes Metabolic Homeostasis and Reduces Obesity and Insulin Resistance,” which appeared in the March 3, 2015
edition of the journal Cell Metabolism.
In pre-clinical models, both CB4209 and CB4211 demonstrated significant therapeutic potential for the treatment of NASH,
showing improvements in triglyceride levels, as well as favorable effects on liver enzyme markers associated with NAFLD and NASH.
Both CB4209 and CB4211 also demonstrated significant therapeutic potential for the treatment of obesity, demonstrating significantly
greater weight loss together with more selective reduction of fat mass versus lean mass in head-to-head comparison to a market-leading
obesity drug in diet induced obese (DIO) mice. The therapeutic effects of CB4209 and CB4211 have been further evaluated in the well-
established preclinical STAM™ mouse model of NASH. In this model, treatment with CB4209 or CB4211 resulted in a significant
reduction of the non-alcoholic fatty liver disease activity score, or NAS, a composite measure of steatosis (fat accumulation), inflammation
and hepatocyte ballooning (cellular injury). Data from these studies were presented at the American Association for the Study of Liver
Disease (AASLD) 2017 Liver Meeting® in October, 2017.
In addition to the therapeutic potential indicated by the pre-clinical models described above, the Company's research has
demonstrated that CB4211 interacts with a cell surface receptor that plays a central role in metabolism. This mechanism of action further
suggests the role of MDPs as an integral component of metabolic regulation and protection. CB4211 represents a first-in-class drug
candidate for the treatment of NASH and obesity with a novel mechanism of action targeting metabolic regulation.
3
Investigational Programs
Our R&D pipeline also includes the MDPs described below. Our pre-clinical activities with respect to these peptides are focused
on identifying and optimizing those MDPs and their analogs that demonstrate the greatest commercial and therapeutic potential as MBTs.
New MDP Analogs: Our internal discovery efforts have resulted in identification of more than 100 previously unidentified MDPs
encoded within the mitochondrial genome. These MDPs and their analogs have demonstrated various degrees of biological activity in a
wide range of cell based and/or animal models relevant to age-related diseases, such as NASH, obesity, T2D, cancer, atherosclerosis,
cardiovascular disease and Alzheimer’s disease.
SHLP Analogs: Our founders and their academic collaborators discovered several peptides encoded within the mitochondrial
genome with a similar origin to humanin, the first discovered peptide; we refer to these as small humanin-like peptides, or SHLPs. In
cancer treatment models conducted by our founders and their collaborators, both in cell culture and in mice, SHLP-6 demonstrated
suppression of cancer progression via mechanisms involving both suppression of tumor angiogenesis (blood vessel development) and
induction of apoptosis (cancer cell death). There is also preclinical evidence to suggest that SHLP-2 has protective effects against neuronal
toxicity. Certain of the SHLP studies were published in a research paper entitled “Naturally occurring mitochondrial-derived peptides are
age-dependent regulators of apoptosis, insulin sensitivity, and inflammatory markers,” which appeared in the April 2016 edition of the
journal Aging.
Humanin Analogs: Humanin has demonstrated protective effects in various animal models of age-related diseases, including
Alzheimer’s disease, atherosclerosis, myocardial and cerebral ischemia and T2D. Humanin levels in humans have been shown to decline
with age, and elevated levels of humanin together with lower incidence of age-related diseases have been observed in centenarians as well
as their offspring. In vitro studies with humanin and humanin analogs have demonstrated protective effects against neuronal toxicity
suggesting that a humanin analog may have potential for development as an MBT treatment for neurodegenerative diseases such as
Alzheimer’s disease.
All of our pipeline MDPs and MBT candidates are in the pre-clinical stage of development, and there is no guarantee that the
activity demonstrated in pre-clinical models will be shown in human testing.
OUR TECHNOLOGY PLATFORM
Our proprietary technology platform is designed to rapidly identify therapeutically relevant peptides encoded within the
mitochondrial genome, to evaluate their biological activity, and to develop these peptides into novel MBTs that have the potential to treat
diseases with major unmet medical needs. We believe our technology platform provides multiple opportunities for value creation. Our
multiplexed peptide optimization process is designed to discover numerous potential drug candidate opportunities with near term value.
These drug candidates can be internally developed by CohBar or advanced through strategic partnerships with larger pharmaceutical
companies. At the same time, our strategy of capturing the most valuable MBT space by aggressively filing for broad intellectual property
coverage is designed to secure CohBar’s leadership role in the field and protect our ability to create additional value in the future.
4
We use a broad range of proprietary activity screens to assess the therapeutic potential of our novel peptides and to prioritize our
development opportunities. Some of our novel peptides have demonstrated promising biological effects in a variety of in vitro and/or in
vivo models of age-related diseases. We are prioritizing our novel peptides by assessing their activity in areas such as metabolic regulation,
oxidative stress, cellular energy levels, cell proliferation, cell death, cellular protection, carbohydrate metabolism, lipid metabolism, body
weight, regulation of body fat, insulin sensitivity, regulation of glucose, glucose tolerance, and liver function.
Disease Focus
Our research and development focuses on diseases associated with aging and metabolic dysfunction. Our research to date suggests
multiple possible therapeutic indications for each of our pipeline MDPs. While we believe our current and any future MBT drug candidates
we identify would be advanced against one of the following diseases as a primary indication, it is possible that we may determine to
advance a drug candidate for treatment of a different disease as a primary indication. We may determine to advance any future drug
candidate against an alternative primary disease indication if, for example, additional data suggests greater therapeutic potential for the
drug candidate against the alternative indication, or we determine that the development, approval or commercialization pathway may be
more favorable for a drug candidate targeted against the alternative indication.
NAFLD and NASH – Non-alcoholic fatty liver disease (NAFLD) is the build-up of extra fat in liver cells that is not due to alcohol
consumption and tends to develop in people who are overweight or obese or have diabetes, high cholesterol or high levels of triglycerides.
Non-alcoholic steatohepatitis (NASH) is a more severe form of NAFLD characterized by swelling of the liver that eventually may lead to
scarring (cirrhosis) and over time to liver cancer or liver failure. NAFLD affects as much as 34% of the U.S. population while as many as
12% of U.S. adults may have NASH. Currently, there are no FDA approved treatments for NAFLD/NASH.
Obesity –– Obesity is now recognized as the most prevalent metabolic disease world-wide, reaching epidemic proportions in both
developed and developing countries and affecting all age groups. More than one-third of the U.S. adult population, and over 40% of U.S.
age groups between 45 and 75, have obesity. The prevalence of class III, or morbid, obesity (body mass index ≥40) has increased
dramatically in several countries and currently affects 6% of adults in the U.S., with an estimated increase of 130% over the next two
decades. Obesity is a major risk factor for age-related diseases such as heart disease, stroke, T2D and certain types of cancer.
Type 2 diabetes mellitus – T2D is a chronic disease characterized by a relative deficiency in insulin production and secretion by
the pancreas and an inability of the body to respond to insulin normally, i.e. insulin resistance. Hyperglycemia, or raised blood sugar, is a
common effect of uncontrolled diabetes and over time leads to serious damage to many of the body’s systems, especially the nerves,
kidneys, eyes and blood vessels.
Cancer – Cancer is a generic term for a large group of diseases that can affect any part of the body. One defining feature of cancer
is the rapid creation of abnormal cells that grow beyond their usual boundaries, and which can then invade adjoining parts of the body and
spread to other organs. This process is referred to as metastasis. Metastases are a major cause of death from cancer. Cancer is a leading
cause of death worldwide. Cancer drugs such as chemotherapy, hormone therapy and other treatments are used to destroy cancer cells. The
goal of cancer drugs is to cure the disease or, when a cure is not possible, to prolong life or improve quality of life for patients with
incurable cancer.
5
Alzheimer’s disease – In the brain, neurons connect and communicate at synapses, where tiny bursts of chemicals called
neurotransmitters carry information from one cell to another. Alzheimer’s, a neurodegenerative disease, disrupts this process and eventually
destroys synapses and kills neurons, damaging the brain’s communication network. There is no cure, and medications on the market today
treat only the symptoms of Alzheimer’s disease and do not have the ability to stop its onset or its progression. There is an urgent and unmet
need for both a disease-modifying drug for Alzheimer’s disease as well as for better symptomatic treatments.
Atherosclerosis – Atherosclerosis is a cardiovascular disease commonly referred to as a “hardening” or furring of the arteries. It is
caused by the formation of multiple atheromatous plaques within the arteries. This process is the major underlying risk for developing
myocardial infarction (heart attack) as those plaques will either narrow the vessel or rupture, preventing blood flow in the coronary artery
to parts of the heart muscle. Heart disease is the leading cause of death for both men and women. Cholesterol lowering drugs are
considered the main preventive approach to treat atherosclerosis, however these drugs are estimated to prevent only one-third of incidences
of myocardial infarction, and there is significant unmet need for additional therapeutic options.
COMPETITION
The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a
strong emphasis on proprietary products. While we believe that our scientific knowledge, technology, and development experience provide
us with competitive advantages, we face potential competition from many different sources, including major pharmaceutical, specialty
pharmaceutical and biotechnology companies, academic institutions and governmental agencies and public and private research institutions.
Many of our competitors may have significantly greater financial resources and capabilities for research and development, manufacturing,
pre-clinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do.
There are numerous therapies currently marketed to treat obesity, T2D, cancer and Alzheimer’s disease. There are no currently
approved therapies for the treatment of NAFLD and NASH, but numerous therapies are in development. These therapies are varied in their
design, therapeutic application and mechanism of action and may provide significant competition for any of our product candidates for
which we obtain market approval. New products or therapies may also become available that provide efficacy, safety, convenience and
other benefits that are not provided by currently marketed products and therapies. As a result, they may provide significant competition for
any of our product candidates for which we obtain market approval.
If a CohBar MBT is developed and approved for treatment of patients with obesity it may compete with products currently
approved for obesity, such as Saxenda, Belviq, Contrave and Qsymia, and investigational therapies that are currently being studied for the
treatment of obesity, such as CB1-receptor-antagonists, 5-HT receptor agonists, SGLT-2 antagonist, GLP-1 agonists and Adenylate Cyclase
3 activators.
If a CohBar MBT is developed and approved for treatment of patients with NASH, it may compete with several investigational
therapies that are currently being studied for the treatment of NAFLD/NASH including, for example, FXR activators, PXR activators,
ACC1/2 inhibitors, PPAR-α, -γ and -δ activators, SREBP2/MIR-33a inhibitors, DGAT1 or 2 inhibitors, CCR2/5 antagonists, and CXCR3
antagonists.
If a CohBar MBT is developed and approved for treatment of patients with T2D, it would compete with several classes of drugs
for T2D that are approved to improve glucose control, including sulfonylureas, glinides, PPAR gamma agonists, biguanides, alpha
glucosidase inhibitors, DPP IV inhibitors, GLP1 agonists, SGLT2 inhibitors, bromocriptine and insulin. Insulin sensitizing agents approved
to treat T2D are the PPAR gamma agonists pioglitazone and rosiglitazone. These agents are not generic, are oral once-daily pills and are
effective in lowering glucose and A1C. Metformin is also sometimes called an insulin sensitizer. It is available as a generic and comes in a
once-daily formulation. Drugs approved for obesity may also be used to treat T2D. In addition, there are several investigational drugs being
studied to treat T2D and if these investigational therapies were approved they would also compete with an MBT developed and approved
for T2D.
6
If a CohBar MBT is developed and approved for the treatment for patients with cancer, it would compete with all approved
therapies for the cancer it is approved to treat. Since the specific cancer that these investigational therapies might be approved to treat is
unknown, they would theoretically compete with any pharmaceutical agent that is approved to treat cancer. In addition, there are several
investigational drugs being studied to treat cancer, and if these investigational therapies were approved, they would also compete with an
MBT developed and approved for the treatment of cancer.
If a CohBar MBT is developed and approved for the treatment for patients with Alzheimer’s disease or other neurodegenerative
diseases, it would compete with all approved therapies to treat Alzheimer’s disease including donepezil (Aricept), galantamine (Razadyne),
memantine (Namenda), rivastigmine (Exelon) and tacrine (Cognex). In addition, there are several investigational drugs being studied to
treat Alzheimer’s and other neurodegenerative diseases that, if approved, would also compete with an MBT developed and approved for the
treatment of Alzheimer’s and other neurodegenerative diseases.
FINANCING
Our business strategy and plans for research and development of our MDPs and MBT candidates includes periodic infusion of new
capital to our Company. We may seek to obtain funding for our business through partnership agreements with pharmaceutical and
biotechnology companies or through the issuance and sale of debt or equity securities in capital raising transactions.
EMPLOYEES
As of March 28, 2018, we had 10 employees, nine full-time and one part-time. In addition to our employees, our founders consult
directly with our employees and scientific staff from time to time to advance our research programs. Our founders provide consulting
services in the areas of peptide research, genetics, aging and age-related diseases, drug discovery, development and commercialization, and
other areas relevant to our business. Additionally, from time to time we engage other subject-matter experts on a consulting basis in
specific areas of our research and development efforts. None of our employees are represented by a labor union or covered by a collective
bargaining agreement. We have not experienced any work stoppages and we consider our relations with our employees to be good.
RESEARCH AND DEVELOPMENT
Research and development activities are central to our business model. Our research programs include activities related to
discovery of novel MDPs, investigational research to evaluate the potential therapeutic effects of certain discovered MDPs in preclinical
models and engineering novel, improved analogs of certain discovered MDPs with characteristics suitable for further development as
potential MBT drug candidates. Depending on factors of capability, cost, efficiency and intellectual property rights we conduct our research
programs independently at our laboratory facility, pursuant to contractual arrangements with CROs or under collaborative arrangements
with academic institutions. Research and development expenses for the years ended December 31, 2017 and 2016 were $6,675,080 and
$3,606,515, respectively.
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INTELLECTUAL PROPERTY
Patents
Our commercial success depends in part on our ability to obtain and maintain proprietary protection for our novel biological
discoveries and therapeutic methods, to operate without infringing on the proprietary rights of others and to prevent others from infringing
our proprietary rights. We seek to protect our proprietary position by, among other methods, licensing and/or filing patent applications
related to our proprietary technology, inventions and improvements that are important to the development and implementation of our
business.
Our intellectual property and patent strategy is focused on our MDPs, their analogs and our MBT candidates. Our strategy is
generally to seek patent protection in the United States and, where applicable, in those international jurisdictions we identify as holding
significant potential market opportunity for any drug we may develop and in which patent protection is available. We also rely on trade
secrets, know-how, continuing technological innovation and potential in-licensing opportunities to develop and maintain our proprietary
position. With respect to new biologically active MDPs that we identify within the mitochondrial genome we typically file provisional
patent applications and seek composition-of-matter and method-of-treatment patents for our MDPs, their analogs, and prospective MBTs
based on pre-clinical evaluation of therapeutic potential. We intend to file non-provisional patent applications for those MDPs and analogs
within our pipeline based on further assessment of their therapeutic and commercial potential, as well as strategic and competitive
considerations. We believe that the opportunity to engineer analogs or create combination therapies will afford us the opportunity to
strengthen IP protection for our drug development candidates as they advance through our development pipeline and to broaden our IP
protection internationally.
We are the exclusive licensee from the UC Regents of four issued patents, that will expire starting in 2028, along with 4 pending
patents. Additionally, CohBar has filed a PCT patent application and a patent application in a foreign territory together with more than 65
provisional patent applications with claims directed to both composition-of-matter and methods-of-use of novel proprietary MDPs and their
analogs.
8
A summary of our licensed, non-provisional patents and patent applications as it relates to specific MDPs and their analogs
appears below:
Therapeutic Activities / Method of Use Claims
Granted
/ Filed
MOTS-c Two Filed
Composition
Claims
ü
Type 1
Diabetes
ü
Type 2
Diabetes
ü
Obesity
ü
Fatty
Liver
ü
ü
ü
ü
SHLP-6
Filed
SHLP-2 Granted
Humanin
Analogs Granted
Humanin
Analogs
Two
Granted
Humanin
and
Humanin
Analogs
Filed
Cancer
Alzheimer’s Atherosclerosis
ü
ü
ü
ü
ü
ü
MOTS-c
Analogs
Two Filed
ü
ü
ü
ü
ü
ü
ü
Terms for individual patents extend for varying periods of time depending on the date of filing of the patent application or the date
of patent issuance and the legal term of patents in the countries in which they are obtained. Generally, patents issued from applications filed
in the United States are effective for twenty years from the earliest non-provisional filing date. In addition, in certain instances, a patent
term can be extended to recapture a portion of the term effectively lost as a result of the FDA regulatory review period, however, the
restoration period cannot be longer than five years and the total patent term, including the restoration period, must not exceed fourteen years
following FDA approval. The duration of foreign patents varies in accordance with provisions of applicable local law, but typically is also
twenty years from the earliest international filing date.
National and international patent laws concerning peptide therapeutics remain highly unsettled. Policies regarding the patent
eligibility or breadth of claims allowed in such patents are currently in flux in the United States and other countries. Changes in either the
patent laws or in interpretations of patent laws in the United States and other countries can diminish our ability to protect our inventions and
enforce our intellectual property rights. Accordingly, we cannot predict the breadth or enforceability of claims that may be granted in our
patents or in third-party patents. The biotechnology and pharmaceutical industries are characterized by extensive litigation regarding
patents and other intellectual property rights. Our ability to maintain and solidify our proprietary position for our drugs and technology will
depend on our success in obtaining effective claims and enforcing those claims once granted. We do not know whether any of the patent
applications that we may file or license from third parties will result in the issuance of any patents. The issued patents that we license, or
may license or own in the future, may be challenged, invalidated or circumvented, and the rights granted under any issued patents may not
provide us with sufficient protection or competitive advantages against competitors with similar technology. Furthermore, our competitors
may be able to independently develop and commercialize similar drugs or duplicate our technology, business model or strategy without
infringing our patents. Because of the extensive time required for clinical development and regulatory review of a drug we may develop, it
is possible that, before any of our drugs can be commercialized, any related patent may expire or remain in force for only a short period
following commercialization, thereby reducing any advantage of any such patent.
9
The patent positions for our research peptides are described below:
MOTS-c Patent Coverage
We are the exclusive licensee from the Regents of the University of California (the “Regents”) to intellectual property rights
related to MOTS-c, including two patent applications filed in the United States (U.S. Application No. 14/213,617 and U.S. Divisional
Application No. 15/146249) and corresponding foreign applications filed in multiple countries and regions. These applications include
composition of matter claims directed to MOTS-c and certain analogs of MOTS-c, as well as methods of use claims for MOTS-c or certain
analogs of MOTS-c as a treatment for type 1 diabetes, type 2 diabetes, fatty liver, obesity and cancer.
MOTS-c Analog Patent Coverage
CohBar has also filed a PCT patent application and a patent application in a foreign territory that covers novel optimized analogs of
MOTS-c with improved properties, including claims directed to composition-of-matter and methods-of-use.
SHLP-2 and SHLP-6 Patent Coverage
We are the exclusive licensee from the Regents to intellectual property for SHLP-2 and SHLP-6 and their analogs. This
intellectual property includes the following issued and pending patents:
● U.S. Patent No. 8,637,470, issued on January 28, 2014, with composition of matter claims directed to SHLP-2 and analogs.
● A divisional patent application in the United States for SHLP-6 (U.S. Application No. 14/134,430), with claims directed at the
SHLP-6 composition of matter, and methods of use in treating cancer.
We are pursuing intellectual property protection related to certain analogs of these peptides.
Humanin and Humanin Analogs Patent Coverage
We are the exclusive licensee from the Regents and the Albert Einstein College of Medicine of Yeshiva University to the
following U.S. patent applications and issued U.S. patents and covering humanin and humanin analogs for treatment of disease.
● U.S. Patent No. 8,309,525, issued on November 13, 2012, with claims covering pharmaceutical compositions of humanin
analogs.
● U.S. Patent No. 7,998,928, issued on August 16, 2011, with claims directed to methods of using a humanin analog to treat type
1 diabetes.
● U.S. Patent No. 8,653,027 issued on February 18, 2014 as a continuation of U.S. Patent 7,998,928, with claims directed to
methods of using an additional humanin analog to treat type 1 diabetes.
● U.S. Patent Application No. 13/526,309 (pending), with claims directed to methods of using humanin or a humanin analog to
treat atherosclerosis.
Newly-Identified MDPs and Analog Coverage
CohBar has also filed more than 65 new provisional patent applications that cover newly-identified MDPs and their novel,
improved analogs, including claims directed to composition-of-matter and methods-of-use. Provisional patent applications are not publicly
available and information regarding the specific MDPs and analogs identified in the provisional applications, and related claims, are held
confidential. We intend to file non-provisional patent applications for those MDPs and analogs within our pipeline based on further
assessment of their therapeutic and commercial potential, as well as strategic and competitive considerations.
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Trade Secrets
In addition to patents, we rely upon unpatented trade secrets, know-how and continuing technological innovation to develop and
maintain our competitive position. We seek to protect our proprietary information, in part, using confidentiality agreements with our
commercial partners, collaborators, employees and consultants and invention assignment agreements with our employees. These
agreements are designed to protect our proprietary information and, in the case of the invention assignment agreements, to grant us
ownership of technologies that are developed through a relationship with a third party. These agreements may be breached, and we may not
have adequate remedies for any breach. In addition, our trade secrets may otherwise become known or be independently discovered by
competitors. To the extent that our commercial partners, collaborators, employees and consultants use intellectual property owned by others
in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions.
Trademarks
We consider COHBARTM to be our common law trademark and are pursuing registration in the United States Patent & Trademark
Office.
In-licenses
MOTS-c Exclusive License
On August 6, 2013, we entered into an exclusive license agreement with the Regents to obtain worldwide, exclusive rights under
patent filings and other intellectual property rights in inventions developed by Dr. Cohen and academic collaborators at the University of
California, Los Angeles. The intellectual property includes the pending U.S. and international patent filings described above under “ MOTS-
c Patent Coverage”.
We agreed to pay the Regents specified development milestone payments aggregating up to $765,000 for the first product sold
under the license. Milestone payments for additional products developed and sold under the license are reduced by 50%. We are also
required to pay annual maintenance fees to the licensors. Aggregate maintenance fees for the first three years following execution of the
agreement are $7,500. Thereafter, we are required to pay maintenance fees of $5,000 annually until the first sale of a licensed product. In
addition, we are required to pay the Regents royalties equal to 2% of our worldwide net sales of drugs, therapies or other products
developed from claims covered by the licensed patent, subject to a minimum royalty payment of $75,000 annually, beginning after the first
commercial sale of a licensed product. We are required to pay the Regents royalties ranging from 8% of worldwide sublicense sales of
covered products (if the sublicense is entered after commencement of phase II clinical trials) to 12% of worldwide sublicense sales (if the
sublicense is entered prior to commencement of phase I clinical trials). The agreement also requires us to meet certain diligence and
development milestones, including filing of an Investigational New Drug (IND) Application for a product covered by the agreement on or
before the seventh anniversary of the agreement date.
Under the agreement, the license rights granted to us are subject to any rights the U.S. Government may have in such licensed
rights due to its sponsorship of research that led to the creation of the licensed rights. The agreement also provides that if the Regents
become aware of a third-party’s interest in exploiting the licensed technologies in a field that we are not actively pursuing, then we may be
obligated either to issue a sublicense for use in the unexploited field to the third-party on substantially similar terms or to actively pursue
the unexploited field subject to appropriate diligence milestones. The agreement terminates upon the expiration of the last valid claim of
the licensed patent rights. We may terminate the agreement at any time by giving the Regents advance written notice. The agreement may
also be terminated by the Regents in the event of our continuing material breach after notice of such breach and the opportunity to cure.
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Humanin and SHLPs Exclusive License
On November 30, 2011, we entered into an exclusive license agreement with the Regents and the Albert Einstein College of
Medicine at Yeshiva University to obtain worldwide, exclusive rights under patent filings and other intellectual property rights in inventions
developed by Drs. Cohen and Barzilai and their academic collaborators. The intellectual property subject to the agreement includes four
issued and two pending U.S. patents including composition claims directed to humanin analogs, SHLP-2 and SHLP-6 and methods of use
claims directed to humanin, humanin analogs and SHLP-6. See “Humanin and Humanin Analogs Patent Coverage” and “SHLP-2 and
SHLP-6 Patent Coverage”.
We agreed to pay the licensors specified development milestone payments aggregating up to $765,000 for the first product sold
under the license. Milestone payments for additional products developed and sold under the license are reduced by 50%. We are also
required to pay annual maintenance fees to the licensors. Aggregate maintenance fees for the first five years following execution of the
agreement are $80,000. Thereafter, we are required to pay maintenance fees of $50,000 annually until the first sale of a licensed product. In
addition, we are required to pay the licensors royalties equal to 2% of our worldwide net sales of drugs, therapies or other products
developed from claims covered by the licensed patents, subject to a minimum royalty payment of $75,000 annually, beginning after the first
commercial sale of a licensed product. We are required to pay royalties ranging from 8% of worldwide sublicense sales of covered products
(if the sublicense is entered after commencement of phase II clinical trials) to 12% of worldwide sublicense sales (if the sublicense is
entered prior to commencement of phase I clinical trials). The agreement also requires us to meet certain diligence and development
milestones, including filing of an IND for a product covered by the agreement on or before the seventh anniversary of the agreement date.
Under the agreement, the license rights granted to us are subject to any rights the U.S. Government may have in such licensed
rights due to its sponsorship of research that led to the creation of the licensed rights. The agreement terminates upon the expiration of the
last valid claim of the licensed patent rights. We may terminate the agreement at any time by giving the Regents advance written notice.
The agreement may also be terminated by the Regents in the event of our continuing material breach after notice of such breach and the
opportunity to cure.
ENVIRONMENTAL AND OTHER REGULATORY MATTERS
Government Regulation
The pre-clinical studies and clinical testing, manufacture, labeling, storage, record keeping, advertising, promotion, export,
marketing and sales, among other things, of our therapeutic candidates and future products, are subject to extensive regulation by
governmental authorities in the United States and other countries. In the United States, pharmaceutical products are regulated by the Food
and Drug Administration (the “FDA”) under the Federal Food, Drug, and Cosmetic Act (the “FDCA”) and other laws. Biologics are
subject to regulation by the FDA under the FDCA, the Public Health Service Act, and related regulations, and other federal, state and local
statutes and regulations. Biological products include, among other things, viruses, therapeutic serums, vaccines and most protein products.
Product development and approval within these regulatory frameworks takes a number of years, and involves the expenditure of substantial
resources.
Regulatory approval will be required in all major markets in which we, or our licensees, seek to test our products in development.
At a minimum, such approval requires evaluation of data relating to quality, safety and efficacy of a product for its proposed use. The
specific types of data required and the regulations relating to these data differ depending on the territory, the drug involved, the proposed
indication and the stage of development.
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In general, new chemical entities are tested in animal models to determine whether the product is reasonably safe for initial human
testing. Additional preclinical testing continues during the clinical development stage. Clinical trials for new products are typically
conducted in three sequential phases that may overlap. Phase 1 trials typically involve the initial introduction of the pharmaceutical into
healthy human volunteers and focus on testing for safety, dosage tolerance, metabolism, distribution, excretion and clinical pharmacology.
In the case of serious or life-threatening diseases, such as cancer, initial Phase 1 trials are often conducted in patients directly, with
preliminary exploration of potential efficacy. Phase 2 trials involve clinical trials to evaluate the effectiveness of the drug for a particular
indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks
associated with the drug. Phase 2 trials are typically closely monitored and conducted in a relatively small number of patients, usually
involving no more than several hundred subjects. Phase 3 trials are generally expanded, well-controlled clinical trials. They are performed
after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information
about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis
for physician labeling.
In the United States, specific pre-clinical data, chemical data and a proposed clinical study protocol, as described above, must be
submitted to the FDA as part of an Investigational New Drug application, or IND, which, unless the FDA objects, will become effective 30
days following receipt by the FDA. Phase 1 trials may commence only after the IND application becomes effective. Following completion
of Phase 1 trials, further submissions to regulatory authorities are necessary in relation to Phase 2 and 3 trials to update the existing IND.
Authorities may require additional preclinical or clinical data before allowing the trials to commence and could demand discontinuation of
studies at any time if there are significant safety issues. In addition to regulatory review, a clinical trial involving human subjects has to be
approved by an independent body. The exact composition and responsibilities of this body differ from country to country. In the United
States, for example, each clinical trial is conducted under the auspices of an Institutional Review Board for any institution at which the
clinical trial is conducted. This board considers among other factors, the design of the clinical trial, ethical factors, the safety of the human
subjects and the possible liability risk for the institution.
Information generated in this process is susceptible to varying interpretations that could delay, limit, or prevent regulatory
approval at any stage of the approval process. Failure to demonstrate adequately the quality, safety and efficacy of a therapeutic drug under
development would delay or prevent regulatory approval of the product.
In order to gain marketing approval, we must submit a new drug application, or NDA, for review by the FDA. The NDA must
include a substantial amount of data and other information concerning safety and effectiveness the drug compound from laboratory, animal
and clinical testing, as well as data and information manufacturing, product stability, and proposed product labeling.
There can be no assurance that if clinical trials are completed that we or any future collaborative partners will submit an NDA or
similar applications outside of the United States for required authorizations to manufacture or market potential products, or that any such
applications will be reviewed or approved in a timely manner. Approval of an NDA, if granted at all, can take several months to several
years, and the approval process can be affected by a number of factors. Additional studies or clinical trials may be requested during the
review and may delay marketing approval and involve unbudgeted costs. Regulatory authorities may conduct inspections of relevant
facilities and review manufacturing procedures, operating systems and personnel qualifications. In addition to obtaining approval for each
product, in many cases each drug manufacturing facility must be approved. Further, inspections may occur over the life of the product. An
inspection of the clinical investigation sites by a competent authority may be required as part of the regulatory approval procedure. As a
condition of marketing approval, the regulatory agency may require post-marketing surveillance to monitor adverse effects, or other
additional studies as deemed appropriate. After approval for the initial indication, further clinical studies are usually necessary to gain
approval for additional indications. The terms of any approval, including labeling content, may be more restrictive than expected and could
affect product marketability.
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Holders of an approved NDA are required to report certain adverse reactions and production problems, if any, to the FDA, and to
comply with certain requirements concerning advertising and promotional labeling for their products. Moreover, quality control and
manufacturing procedures must continue to conform to cGMP after approval, and the FDA periodically inspects manufacturing facilities to
assess cGMP compliance. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality
control to maintain compliance with cGMP and other aspects of regulatory compliance. We expect to continue to rely upon third-party
manufacturers to produce commercial supplies of any products which are approved for marketing. We cannot be sure that those
manufacturers will remain in compliance with applicable regulations, or that future FDA inspections will not identify compliance issues at
the facilities of our contract manufacturers that may disrupt production or distribution, or require substantial resources to correct.
Any of our future products approved by the FDA will likely be purchased principally by healthcare providers that typically bill
various third-party payers, such as governmental programs (e.g., Medicare and Medicaid), private insurance plans and managed care plans,
for the healthcare products and services provided to their patients. The ability of customers to obtain appropriate reimbursement for the
products and services they provide is crucial to the success of new drug and biologic products. The availability of reimbursement affects
which products customers purchase and the prices they are willing to pay. Reimbursement varies from country to country and can
significantly impact the acceptance of new products. Even if we were to develop a promising new product, we may find limited demand for
the product unless reimbursement approval is obtained from private and governmental third-party payers.
If the FDA approves any of our future products and reimbursement for those products is approved by any federal or state
healthcare programs, then we will be subject to federal and state laws, such as the Federal False Claims Act, state false claims acts, the
illegal remuneration provisions of the Social Security Act, and federal and state anti-kickback laws that govern financial and other
arrangements among drug manufacturers and developers and the physicians and other practitioners or facilities that purchase or prescribe
products. Among other things, these laws prohibit kickbacks, bribes and rebates, as well as other direct and indirect payments that are
intended to induce the use or prescription of medical products or services payable by any federal or state healthcare program, and prohibit
presenting a false or misleading claim for payment under a federal or state program. Possible sanctions for violation of any of these
restrictions or prohibitions include loss of eligibility to participate in federal and state reimbursement programs and civil and criminal
penalties. If we fail to comply, even inadvertently, with any of these requirements, we could be required to alter our operations, enter into
corporate integrity, deferred prosecution or similar agreements with state or federal government agencies, and could become subject to
significant civil and criminal penalties.
AVAILABLE INFORMATION
Our common stock is listed on the Nasdaq Capital Market and TSX Venture Exchange and trades under the symbols “CWBR”
and “COB.U”, respectively. Our principal executive offices are located at 1455 Adams Drive, Suite 2050, Menlo Park, California 94025,
and our telephone number is (650) 446-7888. The internet address of our corporate website is http://www.cohbar.com.
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We file annual reports, quarterly reports, current reports, proxy statements and other information with the Securities and Exchange
Commission (the “SEC”) under the Securities Exchange Act of 1934, as amended. You can inspect and obtain a copy of our reports, proxy
statements and other information filed with the SEC at the offices of the SEC’s Public Reference Room at 100 F Street N.E., Washington,
D.C. 20549, on official business days during the hours of 10 a.m. to 3 p.m. EST. Please call the SEC at 1-800-SEC-0330 for further
information on the Public Reference Room. The SEC maintains an internet website at http://www.sec.gov where you can access copies of
most of our SEC filings.
We make our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to
those reports, available free of charge on our corporate website. In addition, our Code of Ethics and Business Conduct and the charters of
our Audit Committee, Compensation Committee and Governance and Nominating Committee are available on our corporate website. The
contents of our corporate website are not incorporated into, or otherwise to be regarded as part of, this Annual Report on Form 10-K.
Item 1A. Risk Factors
CohBar operates in an environment that involves a number of risks and uncertainties. The risks and uncertainties described in this
Annual Report on Form 10-K are not the only risks and uncertainties that we face. Additional risks and uncertainties that presently are not
considered material or are not known to us, and therefore are not mentioned herein, may impair our business operations. If any of the risks
described in this Annual Report on Form 10-K actually occur, our business, operating results and financial position could be adversely
affected.
We will need additional funding and may be unable to raise additional capital when needed, which would force us to delay,
reduce or eliminate our research and development activities.
Our operations to date have consumed substantial amounts of cash, and we expect our capital and operating expenditures to
continue to increase in the next few years. We may not be able to generate significant revenues for several years, if at all. Until we can
generate significant revenues, if ever, we expect to satisfy our future cash needs through equity or debt financing, and/or through any future
development collaborations with commercial partners. We cannot be certain that additional funding will be available on acceptable terms,
or at all. If adequate funds are not available, we may be required to delay, reduce the scope of, or eliminate one or more of our research and
development activities.
We have had a history of losses and no revenue.
Since our conversion to a Delaware corporation in September 2009 through December 31, 2017, we have accumulated losses of
$24,242,688. As of December 31, 2017, we had working capital of $7,372,427 and stockholders’ equity of $7,618,913. We can offer no
assurance that we will ever operate profitably or that we will generate positive cash flow in the future. To date, we have not generated any
revenues from our operations and do not expect to generate any revenue from the sale of products in the near future. As a result, our
management expects the business to continue to experience negative cash flow for the foreseeable future and cannot predict when, if ever,
our business might become profitable.
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Until we can generate significant revenues, if ever, we expect to satisfy our future cash needs through equity or debt financing. We
will need to raise additional funds, and such funds may not be available on commercially acceptable terms, if at all. If we are unable to
raise funds on acceptable terms, we may not be able to execute our business plan, take advantage of future opportunities, or respond to
competitive pressures or unanticipated requirements. This may seriously harm our business, financial condition and results of operations. In
the event we are not able to continue operations our stockholders will likely suffer a complete loss of their investments in our securities.
We are an early-stage biotechnology company and may never be able to successfully develop marketable products or generate
any revenue. We have a very limited relevant operating history upon which an evaluation of our performance and prospects can be
made. There is no assurance that our future operations will result in profits. If we cannot generate sufficient revenues, we may suspend
or cease operations.
We are an early-stage company. Our operations to date have been limited to organizing and staffing our company, business
planning, raising capital, identifying MDPs for further research, developing our intellectual property portfolio, performing research on
identified MDPs and advancing our lead MBT candidate towards clinical studies. We have not generated any revenues to date. All of our
MBTs are in the concept or research stage. Moreover, we cannot be certain that our research and development efforts will be successful or,
if successful, that our MBTs will ever be approved by the FDA. Typically, it takes 10-12 years to develop one new medicine from the time
it is discovered to when it is available for treating patients and longer timeframes are not uncommon. Even if approved, our products may
not generate commercial revenues. We have no relevant operating history upon which an evaluation of our performance and prospects can
be made. We are subject to all of the business risks associated with a new enterprise, including, but not limited to, risks of unforeseen
capital requirements, failure of potential drug candidates either in research, pre-clinical testing or in clinical trials, failure to establish
business relationships and competitive disadvantages against other companies. If we fail to become profitable, we may suspend or cease
operations.
We will seek to establish development and commercialization collaborations, and, if we are not able to establish them on
commercially reasonable terms, we may have to alter our development and commercialization plans.
Our potential drug development programs and the potential commercialization of our drug candidates will require substantial
additional cash to fund expenses. We may decide to collaborate with pharmaceutical or biotechnology companies in connection with the
development or commercialization of our potential drug candidates.
We face significant competition in seeking appropriate collaborators. Whether we reach a definitive collaboration agreement 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. Those factors may include the design or results of clinical
trials, the likelihood of approval by the FDA or similar regulatory authorities outside the United States, the potential market for the subject
product candidate, the costs and complexities of manufacturing and delivering such product candidate to patients, the potential of
competing products, the existence of uncertainty with respect to our ownership of technology, which can exist if there is a challenge to such
ownership without regard to the merits of the challenge and industry and market conditions generally. The collaborator may also consider
alternative product candidates or technologies for similar indications that may be available to collaborate on, and whether such alternative
collaboration project could be more attractive than the one with us for our product candidate.
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There are a limited number of large pharmaceutical companies with whom we could potentially collaborate, and collaborations are
complex and time-consuming to negotiate and document. We may not be able to negotiate collaborations on a timely basis, on acceptable
terms, or at all. If we are unable to do so, we may have to curtail the development of the product candidate for which we are seeking to
collaborate, 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 capital, which may not be available to us on acceptable terms or at all. If we do not
have sufficient funds, we may not be able to further develop our product candidates or bring them to market and generate product revenue.
We may not be successful in our efforts to identify or discover potential drug development candidates.
A key element of our strategy is to identify and test MDPs that play a role in cellular processes underlying our targeted disease
indications. A significant portion of the research that we are conducting involves emerging scientific knowledge and drug discovery
methods. Our drug discovery efforts may not be successful in identifying MBTs that are useful in treating disease. Our research programs
may initially show promise in identifying potential drug development candidates, yet fail to yield candidates for pre-clinical and clinical
development for a number of reasons, including:
● the research methodology used may not be successful in identifying appropriate potential drug development candidates; or
● potential drug development candidates may, on further study, be shown not to be effective in humans, or to have unacceptable
toxicities, harmful side effects, or other characteristics that indicate that they are unlikely to be medicines that will receive
marketing approval and achieve market acceptance.
Research programs to identify new product candidates require substantial technical, financial and human resources. We may
choose to focus our efforts and resources on a potential product candidate that ultimately proves to be unsuccessful. If we are unable to
advance our lead MBT candidate through clinical development or identify other MBTs that are suitable for pre-clinical and clinical
development, we will not be able to obtain product revenues in future periods, which likely would result in significant harm to our financial
position and negatively affect our ability to continue our operations.
Our research and development plans will require substantial additional future funding which could impact our operational
and financial condition. Without the required additional funds, we will likely cease operations.
It will take several years before we are able to develop potentially marketable products, if at all. Our research and development
plans will require substantial additional capital to:
● conduct research, pre-clinical testing and human studies;
● manufacture any future drug development candidate or product at pilot and commercial scale; and
● establish and develop quality control, regulatory, and administrative capabilities to support these programs.
Our future operating and capital needs will depend on many factors, including:
● the pace of scientific progress in our research programs and the magnitude of these programs;
● the scope and results of pre-clinical testing and human studies;
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● the time and costs involved in obtaining regulatory approvals;
● the time and costs involved in preparing, filing, prosecuting, securing, maintaining and enforcing intellectual property rights;
● competing technological and market developments;
● our ability to establish additional collaborations;
● changes in any future collaborations;
● the cost of manufacturing our drug products; and
● the effectiveness of efforts to commercialize and market our products.
We base our outlook regarding the need for funds on many uncertain variables. Such uncertainties include the success of our
research and development initiatives, regulatory approvals, the timing of events outside our direct control such as negotiations with
potential strategic partners and other factors. Any of these uncertain events can significantly change our cash requirements as they
determine such one-time events as the receipt or payment of major milestones and other payments.
Additional funds will be required to support our operations and if we are unable to obtain them on favorable terms, we may be
required to cease or reduce further research and development of our drug product programs, sell or abandon some or all of our intellectual
property, merge with another entity or cease operations.
We have a material weakness in our internal control over financial reporting. In addition, because of our status as an
emerging growth company, our independent registered public accountants are not required to provide an attestation report as to our
internal control over financial reporting for several years.
We are required to annually assess the effectiveness of our internal control over financial reporting pursuant to Section 404 of
Sarbanes-Oxley Act of 2002, as amended (“Sarbanes-Oxley Act”) and to report any material weaknesses in such internal control. A
“material weakness” is a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is a
reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a
timely basis. As of December 31, 2017, we conducted an evaluation of the effectiveness of the design and operation of our internal control
over financial reporting and based on this evaluation we concluded, as of December 31, 2017, that our internal controls over financial
reporting were not effective due to a material weakness (see Item 9A – Controls and Procedures). The material weakness relates to our
having primarily one employee throughout the year assigned to positions that involve processing financial information, resulting in a lack
of segregation of duties so that all journal entries and account reconciliations are reviewed by someone other than the preparer, heightening
the risk of error or fraud. During the fourth quarter of 2017, remedial actions were implemented to address this material weakness. We
hired additional qualified financial staff and implemented procedures to segregate duties to ensure that journal entries and account
reconciliations are reviewed by someone other than the preparer. Additional procedures have been implemented to further strengthen our
controls over financial reporting. If we are unable to maintain effective internal control over financial reporting, we may not be able to
report our financial results accurately, prevent fraud or file our periodic reports in a timely manner.
Our independent registered public accounting firm will not be required to attest formally to the effectiveness of our internal
control over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act until we are no longer an “emerging growth company”
as defined in the Jumpstart our Business Startups Act of 2012 (“JOBS Act”). We will be an emerging growth company until December 31,
2020, although circumstances could cause us to lose that status earlier, including if the market value of our common stock held by non-
affiliates exceeds $700 million as of any June 30th before that time, in which case we would no longer be an emerging growth company as
of the following December 31st. Accordingly, you will not likely be able to depend on any attestation concerning our internal control over
financial reporting from our independent registered public accountants for several years.
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If we fail to demonstrate efficacy in our research and clinical trials, our future business prospects, financial condition and
operating results will be materially adversely affected.
The success of our research and development efforts will be greatly dependent upon our ability to demonstrate efficacy of MBTs
in non-clinical studies, as well as in clinical trials. Non-clinical studies involve testing potential MBTs in appropriate non-human disease
models to demonstrate efficacy and safety. Regulatory agencies evaluate these data carefully before they will approve clinical testing in
humans. If certain non-clinical data reveals potential safety issues or the results are inconsistent with an expectation of the potential drug’s
efficacy in humans, the program may be discontinued or the regulatory agencies may require additional testing before allowing human
clinical trials. This additional testing will increase program expenses and extend timelines. We may decide to suspend further testing on our
potential drugs if, in the judgment of our management and advisors, the non-clinical test results do not support further development.
Moreover, success in research, pre-clinical testing and early clinical trials does not ensure that later clinical trials will be successful,
and we cannot be sure that the results of later clinical trials will replicate the results of prior clinical trials and non-clinical testing. The
clinical trial process may fail to demonstrate that our potential drug candidates are safe for humans and effective for indicated uses. This
failure would cause us to abandon a drug candidate and may delay development of other potential drug candidates. Any delay in, or
termination of, our non-clinical testing or clinical trials will delay the filing of an investigational new drug application and new drug
application with the Food and Drug Administration or the equivalent applications with pharmaceutical regulatory authorities outside the
United States and, ultimately, our ability to commercialize our potential drugs and generate product revenues. In addition, we expect that
our early clinical trials will involve small patient populations. Because of the small sample size, the results of these early clinical trials may
not be indicative of future results.
Following successful non-clinical testing, potential drugs will need to be tested in a clinical development program to provide data
on safety and efficacy prior to becoming eligible for product approval and licensure by regulatory agencies.
If any of our future potential drugs in clinical development become the subject of problems, our ability to sustain our development
programs will become critically compromised. For example, efficacy or safety concerns may arise, whether or not justified, that could lead
to the suspension or termination of our clinical programs. Examples of problems that could arise include, among others:
● efficacy or safety concerns with the potential drug candidates, even if not justified;
● failure of agencies to approve a drug candidate and/or requiring additional clinical or non-clinical studies before prior to
determining approvability;
● manufacturing difficulties or concerns;
● regulatory proceedings subjecting the potential drug candidates to potential recall;
● publicity affecting doctor prescription or patient use of the potential drugs;
● pressure from competitive products; or
● introduction of more effective treatments.
19
Each clinical phase is designed to test attributes of the drug and problems that might result in the termination of the entire clinical
plan. These problems can be revealed at any time throughout the overall clinical program. The failure to demonstrate efficacy in our
clinical trials would have a material adverse effect on our future business prospects, financial condition and operating results.
Even if we are able to develop our potential drugs, we may not be able to obtain regulatory approval, or if approved, we may not
be able to generate significant revenues or successfully commercialize our products, which will adversely affect our financial results
and financial condition and we will have to delay or terminate some or all of our research and development plans which may force us to
cease operations.
All of our potential drug candidates will require extensive additional research and development, including pre-clinical testing and
clinical trials, as well as regulatory approvals, before we can market them. We cannot predict if or when any potential drug candidate we
intend to develop will be approved for marketing. There are many reasons that we may fail in our efforts to develop our potential drug
candidates. These include:
● the possibility that pre-clinical testing or clinical trials may show that our potential drugs are ineffective and/or cause harmful
side effects or toxicities;
● our potential drugs may prove to be too expensive to manufacture or administer to patients;
● our potential drugs may fail to receive necessary regulatory approvals from the United States Food and Drug Administration or
foreign regulatory authorities in a timely manner, or at all;
● even if our potential drugs are approved, we may not be able to produce them in commercial quantities or at reasonable costs;
● even if our potential drugs are approved, they may not achieve commercial acceptance;
● regulatory or governmental authorities may apply restrictions to any of our potential drugs, which could adversely affect their
commercial success; and
● the proprietary rights of other parties may prevent us or our potential collaborative partners from marketing our potential drugs.
If we fail to develop our potential drug candidates, our financial results and financial condition will be adversely affected, we will
have to delay or terminate some or all of our research and development plans and may be forced to cease operations.
If we do not maintain the support of qualified scientific collaborators, our revenue, growth and profitability will likely be
limited, which would have a material adverse effect on our business.
We will need to maintain our existing relationships with leading scientists and/or establish new relationships with scientific
collaborators. We believe that such relationships are pivotal to establishing products using our technologies as a standard of care for various
indications. There is no assurance that our founders, scientific advisors or research partners will continue to work with us or that we will be
able to attract additional research partners. If we are not able to establish scientific relationships to assist in our research and development,
we may not be able to successfully develop our potential drug candidates. If this happens, our business will be adversely affected.
20
We expect to rely on third parties to conduct our clinical trials and some aspects of our research and pre-clinical testing. These
third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research or pre-
clinical testing.
We currently rely on third parties to conduct some aspects of our research and expect to continue to rely on third parties to conduct
additional aspects of our research and pre-clinical testing, as well as any future clinical trials. Any of these third parties may terminate their
engagements with us at any time. If we need to enter into alternative arrangements, it would delay our product research and development
activities.
Our reliance on these third parties for research and development activities will reduce our control over these activities but will not
relieve us of our responsibilities. For example, we will remain responsible for ensuring that each of our clinical trials is conducted in
accordance with the general investigational plan and protocols for the trial. Moreover, the FDA requires us to comply with standards,
commonly referred to as Good Clinical Practices, for conducting, recording and reporting the results of clinical trials to assure that data and
reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. We also are
required to register ongoing clinical trials and post the results of completed clinical trials on a government-sponsored database,
ClinicalTrials.gov, within certain timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.
Furthermore, these third parties may also have relationships with other entities, some of which may be our competitors. If these
third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our clinical trials in accordance with
regulatory requirements or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, marketing approvals for our
drug candidates and will not be able to, or may be delayed in our efforts to, successfully commercialize our medicines.
We also expect to rely on other third parties to store and distribute drug supplies for our clinical trials. Any performance failure on
the part of our distributors could delay clinical development or marketing approval of our drug candidates or commercialization of our
products, producing additional losses and depriving us of potential product revenue.
We contract with third parties for the manufacture of our peptide materials for research and pre-clinical testing and expect to
continue to do so for any future product candidate advanced to clinical trials and commercialization. This reliance on third parties
increases the risk that we will not have sufficient quantities of our research peptide materials, product candidates or medicines, or that
such supply will not be available to us at an acceptable cost, which could delay, prevent or impair our research, development or
commercialization efforts.
We do not have manufacturing facilities adequate to produce our research peptide materials or supplies of any future product
candidate. We currently rely, and expect to continue to rely, on third-party manufacturers for the manufacture of our peptide materials, our
current and any future product candidates for pre-clinical and clinical testing, and for commercial supply of any of these product candidates
for which we or future collaborators obtain marketing approval. We do not have long term supply agreements with any third-party
manufacturers, and we purchase our research peptides on a purchase order basis.
We may be unable to establish any agreements with third-party manufacturers or to do so on acceptable terms. Even if we are able
to establish agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:
● reliance on the third party for regulatory compliance and quality assurance;
● the possible breach of the manufacturing agreement by the third party;
● the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us; and
● reliance on the third party for regulatory compliance, quality assurance, and safety and pharmacovigilance reporting.
21
Third-party manufacturers may not be able to comply with current good manufacturing practices, or cGMP, regulations or similar
regulatory requirements outside the United States. Our failure, or the failure of our third-party manufacturers, to comply with applicable
regulations could result in sanctions being imposed on us, including fines, injunctions, civil penalties, delays, suspension or withdrawal of
approvals, license revocation, seizures or recalls of product candidates or medicines, operating restrictions and criminal prosecutions, any
of which could significantly and adversely affect supplies of our medicines and harm our business and results of operations.
Any drug candidate that we may develop may compete with other drug candidates and products for access to manufacturing
facilities. There are a limited number of manufacturers that operate under cGMP regulations and that might be capable of manufacturing for
us.
Our current and anticipated future dependence upon others for the manufacture of our investigational materials or future product
candidates or medicines may adversely affect our future profit margins and our ability to commercialize any medicines that receive
marketing approval on a timely and competitive basis.
We may not be able to develop drug candidates, market or generate sales of our products to the extent anticipated. Our
business may fail and investors could lose all of their investment in our Company.
Assuming that we are successful in developing our potential drug candidates and receiving regulatory clearances to market our
potential products, our ability to successfully penetrate the market and generate sales of those products may be limited by a number of
factors, including the following:
● if our competitors receive regulatory approvals for and begin marketing similar products in the United States, the European
Union, Japan and other territories before we do, greater awareness of their products as compared to ours will cause our
competitive position to suffer;
● information from our competitors or the academic community indicating that current products or new products are more
effective or offer compelling other benefits than our future products could impede our market penetration or decrease our future
market share; and
● the pricing and reimbursement environment for our future products, as well as pricing and reimbursement decisions by our
competitors and by payers, may have an effect on our revenues.
If any of these happened, our business could be adversely affected.
Any product candidate we are able to develop and commercialize would compete in the marketplace with existing therapies and
new therapies that may become available in the future. These competitive therapies may be more effective, less costly, more easily
administered, or offer other advantages over any product we seek to market.
Although there are no currently approved therapies for the treatment of NAFLD and NASH, there are numerous therapies in
development. Additionally, there are numerous therapies currently marketed to treat diabetes, cancer, Alzheimer’s disease and other
diseases for which our potential product candidates may be indicated. For example, if we develop an approved treatment for type 2
diabetes, it would compete with several classes of drugs for type 2 diabetes that are approved to improve glucose control. These include the
insulin sensitizers pioglitazone (Actos) and rosiglitazone (Avandia), which are administered as oral once daily pills, and metformin, which
is sometimes called an insulin sensitizer and is available as a generic once daily formulation. If we develop an approved treatment for
Alzheimer’s disease it would compete with approved therapies such as donepezil (Aricept), galantamine (Razadyne), memantine
(Namenda), rivastigmine (Exelon) and tacrine (Cognex). These therapies are varied in their design, therapeutic application and mechanism
of action and may provide significant competition for any of our product candidates for which we obtain market approval. New products
may also become available that provide efficacy, safety, convenience and other benefits that are not provided by currently marketed
therapies. As a result, they may provide significant competition for any of our product candidates for which we obtain market approval.
Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more
effective, have fewer or less severe side effects, are more convenient or are less expensive than any products that we may develop. Our
competitors also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which
could result in our competitors establishing a strong market position before we are able to enter the market. In addition, our ability to
compete may be affected in many cases by insurers or other third-party payers seeking to encourage the use of existing products which are
generic or are otherwise less expensive to provide.
22
Our future success depends on key members of our scientific team and our ability to attract, retain and motivate qualified
personnel.
We are highly dependent on our founders, Dr. Pinchas Cohen and Dr. Nir Barzilai, and the other principal members of our
management and scientific teams. Drs. Cohen and Barzilai are members of our board of directors and provide certain scientific and research
advisory services to us. Other members of our key management and scientific teams, including our Chief Scientific Officer, Dr. Kenneth
Cundy, are employed “at will,” meaning we or they may terminate the employment relationship at any time. Our consultants and advisors,
including our founders, may be employed by employers other than us and may have commitments under consulting or advisory contracts
with other entities that may limit their availability to us. In addition, we rely on other consultants and advisors from time to time, including
drug discovery and development advisors, to assist us in formulating our research and development strategy. Agreements with these
advisors typically may be terminated by either party, for any reason, on relatively short notice. We do not maintain “key person” insurance
for any of the key members of our team. The loss of the services of any of these persons could impede the achievement of our research,
development and commercialization objectives.
Recruiting and retaining qualified scientific, clinical, and managerial personnel will also be critical to our success. We may not be
able to attract and retain these personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology
companies for similar personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and
research institutions.
We expect to expand our research, development and regulatory capabilities, and as a result, we may encounter difficulties in
managing our growth, which could disrupt our operations.
We expect to experience significant growth in the scope of our operations, particularly in the areas of research, drug development
and regulatory affairs. To manage our anticipated future growth, we must continue to implement and improve our managerial, operational
and financial systems, expand our facilities and continue to recruit and train additional qualified personnel. Due to our limited financial
resources and our limited operating history, we may not be able to effectively manage the expected expansion of our operations. Any
inability to manage growth could delay the execution of our business plans or disrupt our operations.
The use of any of our products in clinical trials may expose us to liability claims, which may cost us significant amounts of
money to defend against or pay out, causing our business to suffer.
The nature of our business exposes us to potential liability risks inherent in the testing, manufacturing and marketing of our
products. We do not currently have any drug candidates in clinical trials, however, if any of our drug candidates enter into clinical trials or
become marketed products, they could potentially harm people or allegedly harm people, possibly subjecting us to costly and damaging
product liability claims. Some of the patients who participate in clinical trials are already ill when they enter a trial or may intentionally or
unintentionally fail to meet the exclusion criteria. The waivers we obtain may not be enforceable and may not protect us from liability or
the costs of product liability litigation. Although we intend to obtain product liability insurance which we believe is adequate, we are
subject to the risk that our insurance will not be sufficient to cover claims. The insurance costs along with the defense or payment of
liabilities above the amount of coverage could cost us significant amounts of money and management distraction from other elements of
the business, causing our business to suffer.
23
The patent positions of biopharmaceutical products are complex and uncertain and we may not be able to protect our patented
or other intellectual property. If we cannot protect this property, we may be prevented from using it or our competitors may use it and
our business could suffer significant harm. Also, the time and money we spend on acquiring and enforcing patents and other
intellectual property will reduce the time and money we have available for our research and development, possibly resulting in a slow
down or cessation of our research and development.
We own or exclusively license patents and patent applications related to our MDPs and potential MBTs and we anticipate
continuing to develop our intellectual property portfolio. However, neither patents nor patent applications ensure the protection of our
intellectual property for a number of reasons, including the following:
● The United States Supreme Court rendered a decision in Molecular Pathology vs. Myriad Genetics, Inc., 133 S.Ct. 2107
(2013) (“Myriad”), in which the court held that naturally occurring DNA segments are products of nature and not patentable as
compositions of matter. On March 4, 2014, the U.S. Patent and Trademark Office (“USPTO”) issued guidelines for
examination of such claims that, among other things, extended the Myriad decision to any natural product. Since MDPs are
natural products isolated from cells, the USPTO guidelines may affect allowability of some of our patent claims (pertaining to
natural MDP sequences) that are filed in the USPTO but are not yet issued. Further, while the USPTO guidelines are not
binding on the courts, it is likely that as the law of subject matter eligibility continues to develop Myriad will be extended to
natural products other than DNA. Thus, our issued U.S. patent claims directed to MDPs as compositions of matter may be
vulnerable to challenge by competitors who seek to have our claims rendered invalid. While Myriad and the USPTO guidelines
described above will affect our patents only in the United States, there is no certainty that similar laws or regulations will not be
adopted in other jurisdictions.
● Competitors may interfere with our patenting process in a variety of ways. Competitors may claim that they invented the
claimed invention prior to us. Competitors may also claim that we are infringing their patents and restrict our freedom to
operate. Competitors may also contest our patents and patent applications, if issued, by showing in various patent offices that,
among other reasons, the patented subject matter was not original, was not novel or was obvious. In litigation, a competitor
could claim that our patents and patent applications are not valid or enforceable for a number of reasons. If a court agrees, we
would lose some or all of our patent protection.
● As a company, we have no meaningful experience with competitors interfering with our patents or patent applications. In order
to enforce our intellectual property, we may need to file a lawsuit against a competitor. Enforcing our intellectual property in a
lawsuit can take significant time and money. We may not have the resources to enforce our intellectual property if a third party
infringes an issued patent claim. Infringement lawsuits may require significant time and money resources. If we do not have
such resources, the licensor is not obligated to help us enforce our patent rights. If the licensor does take action by filing a
lawsuit claiming infringement, we will not be able to participate in the suit and therefore will not have control over the
proceedings or the outcome of the suit.
● Because of the time, money and effort involved in obtaining and enforcing patents, our management may spend less time and
resources on developing potential drug candidates than they otherwise would, which could increase our operating expenses and
delay product programs.
24
● Our licensed patent applications directed to the composition and methods of using MOTS-c, and SHLP-6, which we consider as
a research peptide for the potential treatment of cancer, have not yet been issued. There can be no assurance that these or our
other licensed patent applications will result in the issuance of patents, and we cannot predict the breadth of claims that may be
allowed in our currently pending patent applications or in patent applications we may file or license from others in the future.
● Issuance of a patent may not provide much practical protection. If we receive a patent of narrow scope, then it may be easy for
competitors to design products that do not infringe our patent(s).
● We have limited ability to expand coverage of our licensed patent related to SHLP-2 and our licensed patent application related
to SHLP-6 outside of the United States. The lack of patent protection in international jurisdictions may inhibit our ability to
advance MBT drug candidates in these markets.
● If a court decides that the method of manufacture or use of any of our drug candidates infringes on a third-party patent, we may
have to pay substantial damages for infringement.
● A court may prohibit us from making, selling or licensing a potential drug candidate unless the patent holder grants a license. A
patent holder is not required to grant a license. If a license is available, we may have to pay substantial royalties or grant cross
licenses to our patents, and the license terms may be unacceptable.
● Redesigning our potential drug candidates so that they do not infringe on other patents may not be possible or could require
substantial funds and time.
It is also unclear whether our trade secrets are adequately protected. While we use reasonable efforts to protect our trade secrets,
our employees or consultants may unintentionally or willfully disclose our information to competitors. Enforcing a claim that someone
illegally obtained and is using our trade secrets is expensive and time consuming, and the outcome is unpredictable. In addition, courts
outside the United States are sometimes less willing to protect trade secrets. Our competitors may independently develop equivalent
knowledge, methods and know-how. We may also support and collaborate in research conducted by government organizations, hospitals,
universities or other educational institutions. These research partners may be unable or unwilling to grant us exclusive rights to technology
or products derived from these collaborations prior to entering into the relationship.
If we do not obtain required intellectual property rights, we could encounter delays in our drug development efforts while we
attempt to design around other patents or even be prohibited from developing, manufacturing or selling potential drug candidates requiring
these rights or licenses. There is also a risk that disputes may arise as to the rights to technology or potential drug candidates developed in
collaboration with other parties.
Significant disruptions of information technology systems or security breaches could adversely affect our business.
We are increasingly dependent upon information technology systems, infrastructure and data to operate our business. In the
ordinary course of business, we collect, store and transmit large amounts of confidential information (including, among other things, trade
secrets or other intellectual property, proprietary business information and personal information). It is critical that we do so in a secure
manner to maintain the confidentiality and integrity of such confidential information. We also have outsourced elements of our operations
to third parties, and as a result we manage a number of third-party vendors who may or could have access to our confidential information.
The size and complexity of our information technology systems, and those of third-party vendors with whom we contract, and the large
amounts of confidential information stored on those systems, make such systems vulnerable to service interruptions or to security breaches
from inadvertent or intentional actions by our employees, third-party vendors, and/or business partners, or from cyber-attacks by malicious
third parties. Cyber-attacks could include the deployment of harmful malware, ransomware, denial-of-service attacks, social engineering
and other means to affect service reliability and threaten the confidentiality, integrity and availability of information.
25
Significant disruptions of our information technology systems, or those of our third-party vendors, or security breaches could
adversely affect our business operations and/or result in the loss, misappropriation and/or unauthorized access, use or disclosure of, or the
prevention of access to, confidential information, including, among other things, trade secrets or other intellectual property, proprietary
business information and personal information, and could result in financial, legal, business and reputational harm to us.
If securities or industry analysts do not publish or cease publishing research or reports about us, our business or our market,
or if they change their recommendations regarding our stock adversely, our stock price and trading volume could decline.
The trading market for our common stock will be influenced by the research and reports that industry or securities analysts may
publish about us, our business, our market, or our competitors. If any of the analysts who may cover us change their recommendation
regarding our stock adversely, or provide more favorable relative recommendations about our competitors, our stock price would likely
decline. If any analysts who may cover us were to cease coverage or our company or fail to regularly publish reports on us, we could lose
visibility in the financial markets, which in turn could cause our stock price or trading volume to decline.
Shares of our common stock eligible for future sale in the public marketplace may adversely affect the market price of our
common stock.
The price of our common stock could decline if there are substantial sales of our common stock in the public stock market. There
were 39,439,505 shares of our common stock outstanding as of December 31, 2017. Of these, 14,037,721 shares were held by our officers
and directors and are currently eligible for resale under an effective registration statement filed with the Securities and Exchange
Commission. Sales of a substantial number of these shares, or the perception in the market that the holders of a large number of shares are
able to or intend to sell shares, could reduce the market price of our common stock.
The market price of our common stock may be highly volatile.
The market for our common stock will likely be characterized by significant price volatility when compared to more established
issuers and we expect that it will continue to be so for the foreseeable future. The market price of our common stock is likely to be volatile
for a number of reasons. First, our common stock is likely to be sporadically and/or thinly traded. As a consequence of this lack of liquidity,
the trading of relatively small quantities of common stock by our stockholders may disproportionately influence the price of the common
stock in either direction. The price of the common stock could, for example, decline precipitously if even a relatively small number of
shares are sold on the market without commensurate demand, as compared to a market for shares of an established issuer which could better
absorb those sales without adverse impact on its share price. Secondly, we are a speculative investment due to our lack of profits to date and
substantial uncertainty regarding our ability to develop and commercialize a drug product from our new or existing technologies. As a
consequence of this enhanced risk, more risk-adverse investors may, under the fear of losing all or most of their investment in the event of
negative news or lack of progress, be more inclined to sell their shares on the market more quickly and at greater discounts than would be
the case with the shares of an established issuer. We cannot make any predictions or projections as to what the prevailing market price for
our common stock will be at any time or as to what effect the sale of common stock or the availability of common stock for sale at any time
will have on the prevailing market price.
26
Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
Under Section 382 and related provisions of the Internal Revenue Code of 1986, as amended (the “Code”), if a corporation
undergoes an “ownership change” (generally defined as a greater than 50% change (by value) in its equity ownership over a three year
period), the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes to offset its post-
change income may be limited. We may in the future as a result of subsequent shifts in our stock ownership experience an “ownership
change.” Thus, our ability to utilize carryforwards of our net operating losses and other tax attributes to reduce future tax liabilities may be
substantially restricted. At this time, we have not completed a full study to assess whether an ownership change under Section 382 of the
Code occurred due to the costs and complexities associated with such a study. Further, U.S. tax laws limit the time during which these
carryforwards may be applied against future taxes. Therefore, we may not be able to take full advantage of these carryforwards for federal
or state tax purposes.
Our management owns a significant percentage of our outstanding common stock. If the ownership of our common stock
continues to be highly concentrated in management, it may prevent other stockholders from influencing significant corporate decisions.
As of March 28, 2018, our executive officers and directors own, as a group, approximately 35.2% of the outstanding shares of our
common stock. Additionally, our executive officers and directors own, as a group, options and warrants exercisable for approximately
12.4% of our outstanding common stock, assuming exercise of such options and warrants. As a result, our management could exert
significant influence over matters requiring stockholder approval, including the election of our board of directors, the approval of mergers
and other extraordinary transactions, as well as the terms of any of these transactions. This concentration of ownership could have the
effect of delaying or preventing a change in our control or otherwise discouraging a potential acquirer from attempting to obtain control of
us, which could in turn have an adverse effect on the fair market value of our company and our common stock. These actions may be taken
even if they are opposed by our other stockholders.
The requirements of being a public company may strain our resources, divert management’s attention and require us to
disclose information that is helpful to competitors, make us more attractive to potential litigants and make it more difficult to attract and
retain qualified personnel.
As a public company, we are subject to the reporting requirements of the Securities Act, the Securities Exchange Act of 1934, as
amended (Exchange Act), the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act),
and applicable Canadian securities rules and regulations. Despite recent reforms made possible by the JOBS Act, compliance with these
rules and regulations creates significant legal and financial compliance costs and makes some activities difficult, time-consuming or costly.
The Exchange Act and applicable Canadian provincial securities legislation require, among other things, that we file annual, quarterly, and
current reports with respect to our business and operating results.
Additionally, the Sarbanes-Oxley Act and the related rules and regulations of the SEC and the Nasdaq Capital Market, as well as
the rules and regulations of applicable Canadian securities regulators and the rules of the TSX-V, require us to implement particular
corporate governance practices and adhere to a variety of reporting requirements and complex accounting rules. Among other things, we are
subject to rules regarding the independence of the members of our board of directors and committees of the board and their experience in
finance and accounting matters and certain of our executive officers are required to provide certifications in connection with our quarterly
and annual reports filed with the SEC and applicable Canadian securities regulators. The perceived personal risk associated with these rules
may deter qualified individuals from accepting these positions. Accordingly, we may be unable to attract and retain qualified officers and
directors. If we are unable to attract and retain qualified officers and directors, our business and our ability to maintain the listing of our
shares of common stock on the Nasdaq or another stock exchange could be adversely affected.
27
We are an emerging growth company, and we cannot be certain if the reduced reporting requirements applicable to emerging
growth companies will make our common stock less attractive to investors.
We are an “emerging growth company,” as defined in the JOBS Act. For as long as we continue to be an emerging growth
company, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies that are
not emerging growth companies, including not being required to comply with the auditor attestation requirements of Section 404 of the
Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and
exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any
golden parachute payments not previously approved. We could be an emerging growth company through December 31, 2020, although
circumstances could cause us to lose that status earlier, including if we have more than $1.0 billion in annual revenue, the market value of
our common stock held by non-affiliates exceeds $700 million as of any June 30 (the last day of our second fiscal quarter) before that time,
or we issue more than $1.0 billion of non-convertible debt over a three-year period, in which case we would no longer be an emerging
growth company as of the following December 31 (the last day of our fiscal year). 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 irrevocably elected not to avail ourselves of this exemption from new or revised
accounting standards and, therefore, will be subject to the same new or revised accounting standards as other public companies that are not
emerging growth companies. Recent accounting standards that have been issued or proposed by the FASB or other standards-setting bodies
that do not require adoption until a future date are not expected to have a material impact on our financial statements upon adoption.
Item 1B. Unresolved Staff Comments
None.
Item 2. Properties
We are a party to a lease agreement for laboratory space leased on a month-to month basis that is part of a shared facility in Menlo
Park, California. In October 2017, we entered into a one-year lease agreement for office space in Fairfield, New Jersey at a cost of $13,080
per annum.
Rent expense amounted to $236,374 and $171,294 for the years ended December 31, 2017 and 2016, respectively.
Item 3. Legal Proceedings
From time to time, we may be subject to legal proceedings and claims in the ordinary course of business. We are not currently a
party to any material legal proceedings, and to our knowledge none is threatened. There can be no assurance that future legal proceedings
arising in the ordinary course of business or otherwise will not have a material adverse effect on our financial position, results of operations
or cash flows.
Item 4. Mine Safety Disclosures
Not applicable.
28
PART II
Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Market for our Common Stock
Our common stock has traded on the TSX Venture Exchange (the “TSX-V”) under the symbol “COB.U” since January 8, 2015.
Prior to that date, there was no public trading market for our common stock. Our initial public offering was priced at USD $1.00 per share
on January 6, 2015. The following table sets forth for the periods indicated, the high and low sales prices from the TSX-V.
Market price per share of common stock
High sales price
Low sales price
Market price per share of common stock
High sales price
Low sales price
March 31
June 30
September 30 December 31
Quarters Ended 2017
$
$
2.64 $
1.70 $
2.50 $
1.50 $
3.65 $
1.60 $
7.50
3.30
March 31
June 30
September 30 December 31
Quarters Ended 2016
$
$
1.68 $
1.05 $
3.30 $
1.60 $
2.50 $
2.40 $
2.42
2.00
On March 28, 2018, the closing price for our common stock as reported on the TSX-V was USD $5.35 per share.
Our common stock was quoted for trading on the OTC Markets Group OTCQX marketplace (the “OTCQX”) under the symbol
“CWBR” from May 20, 2015 until December 14, 2017. We moved to the Nasdaq Capital Market (“NASDAQ”) and began trading there on
December 15, 2017. The following table sets forth, for the periods indicated, the high and low bid prices for our common stock as
determined from quotations on the OTCQX. The quotations reflect inter-dealer prices, without retail markup, markdown, or commissions,
and may not represent actual transactions. The prices listed for the quarter ended December 31, 2017, reflects pricing though the last day of
trading, December 14, 2017.
Bid price per share of common stock
High bid price
Low bid price
Bid price per share of common stock
High bid price
Low bid price
March 31
June 30
September 30 December 31
Quarters Ended 2017
$
$
2.30 $
1.50 $
1.97 $
1.40 $
3.30 $
1.44 $
7.00
3.29
March 31
June 30
September 30 December 31
Quarters Ended 2016
$
$
1.60 $
1.03 $
2.88 $
1.53 $
2.35 $
2.06 $
2.30
1.90
29
Our common stock began trading on the NASDAQ under the symbol “CWBR” On December 15, 2017. The following table sets
forth for the periods indicated, the high and low sales prices from the NASDAQ.
Market price per share of common stock
High sales price
Low sales price
March 31
June 30
September 30 December 31
Quarters Ended 2017
$
$
- $
- $
- $
- $
- $
- $
6.15
4.80
On March 28, 2018, the closing price for our common stock as reported on the NASDAQ was $5.30 per share.
Holders of Common Stock
As of March 28, 2018, there were 39,956,147 shares of our common stock outstanding held by 75 holders of record and
approximately 2,500 beneficial shareholders.
Dividends
We have not declared or paid a cash dividend on our capital stock and do not intend to pay cash dividends for the foreseeable
future. All dividends are subject to the approval of our board of directors. Any future determinations to pay dividends on our capital stock
would depend on our results of operations, our financial condition and liquidity requirements, restrictions that may be imposed by
applicable laws or our contracts, and any other factors that our board of directors in its sole discretion may consider relevant in declaring a
dividend.
Share Repurchases
During the year ended December 31, 2017, there were no purchases of shares of common stock made by, or on behalf of, the
Company as defined by Rule 10b-18 of the Securities Exchange Act of 1934.
Equity Compensation Plans
See Item 12 for Equity Compensation Plan information.
Item 6. Selected Financial Data
Not applicable.
30
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Overview
We are an innovative biotechnology company and a leader in the research and development of mitochondria based therapeutics
(MBTs), an emerging class of drugs with the potential to treat a wide range of diseases associated with aging and metabolic dysfunction,
including non-alcoholic steatohepatitis (NASH), obesity, fatty liver disease (NAFLD), type 2 diabetes mellitus (T2D), cancer,
atherosclerosis, cardiovascular disease and neurodegenerative diseases such as Alzheimer’s disease.
MBTs originate from almost two decades of research by our founders, resulting in their discovery of a novel group of
mitochondrial-derived peptides (MDPs) encoded within the genome of mitochondria. Some of these naturally occurring MDPs and certain
related analogs have demonstrated a range of biological activity and therapeutic potential in pre-clinical models across multiple diseases
associated with aging.
We are focused on building our organization, enhancing our scientific and management teams and their capabilities, planning and
strategy, raising capital and the research and development of our MDPs. Our research efforts have focused on discovering and evaluating
our MDPs for potential development as MBT drug candidates. We seek to identify and advance research on MDPs with superior potential
for yielding a MBT drug candidate, and ultimately a drug, for which we have a strong intellectual property position.
In September 2016, we advanced two novel, optimized analogs of our MOTS-c MDP, CB4209 and CB4211, into IND-enabling
studies as our lead MBT candidates for the potential treatment of NASH and obesity. In November 2017 we announced the selection of
CB4211 as the final candidate for the remaining pre-IND studies, with initiation of a first-in-human Phase 1 a/b clinical trial targeted for
mid-2018, followed by an activity readout relevant to NASH and obesity projected in early 2019.
To date, our founders and scientific team have discovered a large number of MDPs that have demonstrated a range of biological
activities and therapeutic potential. Our ongoing research and development of our pipeline MDPs is focused on identifying and advancing
novel improved analogs of those MDPs that have the greatest therapeutic and commercial potential for development into drugs.
We have financed our operations primarily with proceeds from sales of our equity securities, including our initial public offering
(“IPO”), private placements, and the exercise of outstanding warrants and stock options. Since our inception through December 31, 2017,
our operations have been funded with an aggregate of approximately $30.9 million from the issuance of equity instruments.
Since inception, we have incurred significant operating losses. Our net losses were $9,833,152 and $6,074,999 for the years ended
December 31, 2017 and 2016, respectively. As of December 31, 2017, we had an accumulated deficit of $24,242,688. We expect to
continue to incur significant expenses and operating losses over the next several years. Our net losses may fluctuate significantly from
quarter to quarter and from year to year. We anticipate incurring increasing expenses as we advance CB4211 to the clinic, conduct pre-
clinical development of our other research peptides, continue development of our MBTs and seek to expand our intellectual property
portfolio.
Financial Operations Review
Revenue
To date, we have not generated any revenue from product sales and do not expect to generate any revenue from the sale of
products in the near future. In the future, we will seek to generate revenue from product sales, either directly or under any future licensing,
development or similar relationship with a strategic partner.
31
Research and Development Expenses
Research and development expenses consist primarily of costs incurred for our research activities, including our drug discovery
efforts, and the development of our product candidates, which include:
● employee-related expenses including salaries, benefits, and stock-based compensation expense;
● expenses incurred under agreements with third parties, including contract research organizations, or CROs, that conduct
research and development and pre-clinical activities on our behalf and the cost of consultants;
● the cost of laboratory equipment, supplies and manufacturing MBT test materials; and
● depreciation and other personnel-related costs associated with research and product development.
We expense all research and development expenses as incurred. We expect our research and development expenses to increase in
the year ending December 31, 2018, as we continue our efforts to advance our lead MBT candidate program and to discover, evaluate and
optimize other MDPs as potential MBT drug candidates.
Our Research Programs
Our research programs include IND-enabling activities for our lead MBT candidate program, as well as operation of our platform
technology related to discovery of new MDPs, investigational research to evaluate the therapeutic potential of certain discovered MDPs
and engineering analogs of certain discovered MDPs to improve their characteristics as potential MBT drug development candidates.
Depending on factors of capability, cost, efficiency and intellectual property rights we conduct our research programs independently at our
laboratory facility, pursuant to contractual arrangements with CROs or under collaborative arrangements with academic institutions.
The success of our research programs and the timing of those programs and the possible development of a research peptide into a
drug candidate is highly uncertain. As such, at this time, we cannot reasonably estimate or know the nature, timing or estimated costs of the
efforts that will be necessary to complete research and development of a commercial drug. We are also unable to predict when, if ever, we
will receive material net cash inflows from our operations. This is due to the numerous risks and uncertainties associated with developing
medicines, including the uncertainty of:
● establishing an appropriate safety profile with toxicology studies;
● successfully designing, enrolling and completing clinical trials;
● receiving marketing approvals from applicable regulatory authorities;
● establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers;
● obtaining and enforcing patent and trade secret protection for our product candidates;
● launching commercial sales of the products, if and when approved, whether alone or in collaboration with others; and
● maintaining an acceptable safety profile of the products following approval.
A change in the outcome of any of these variables with respect to the development of any of our product candidates would
significantly change the costs and timing associated with the development of that product candidate.
32
Research and development activities are central to our business model. Our MBT drug target candidates are in early stages of
investigational research. 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 research and
development costs to increase significantly for the foreseeable future as our product candidate development programs progress. However,
we do not believe that it is possible at this time to accurately project total program-specific expenses through commercialization. There are
numerous factors associated with the successful commercialization of any of our product candidates, including future trial design and
various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development.
Additionally, future commercial and regulatory factors beyond our control will impact our clinical development programs and plans.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for
personnel in executive, finance and administrative functions. Other significant costs include legal fees relating to patent and corporate
matters and fees for accounting and consulting services. We anticipate that our general and administrative expenses will remain relatively
constant in the year ending December 31, 2018.
Results of Operations
The following tables set forth our results of operations for the periods presented. The year-to-year comparison of financial results
is not necessarily indicative of financial results to be achieved in future periods.
Operating expenses:
Research and development
General and administrative
Total operating expenses
Comparison of Fiscal Years Ended December 31, 2017 and 2016
Operating Expenses
For The Years Ended
December 31,
2017
2016
Change
$
%
$
$
6,675,080 $
3,184,166
9,859,246 $
3,606,515 $
2,470,062
6,076,577 $
3,068,565
714,104
3,782,669
85%
29%
62%
Research and development expenses were $6,675,080 in the year ended December 31, 2017 compared to $3,606,515 in the prior
year, a $3,068,565 increase, or 85%. The increase in research and development expenses in the year ended December 31, 2017, was
primarily due to an increase of approximately $2,759,000 related to our IND-enabling activities associated with advancing our lead drug
candidates into clinical studies and a $510,000 increase in stock-based compensation relating to the costs of new grants and the revaluation
of options granted to consultants that are revalued at each balance sheet date. The increase in research and development expenses was offset
by a decrease of approximately $267,000 in purchases of laboratory supplies and preclinical studies due to the cost, mix and timing of those
purchases and studies. We expect our research and development expenses to increase in the year ending December 31, 2018, as we continue
to advance our lead MBT candidate program, begin to incur the costs of clinical trials and evaluate and optimize other MDPs as potential
MBT drug candidates.
General and administrative expenses were $3,184,166 in the year ended December 31, 2017 compared to $2,470,062 in the prior
year, a $714,104 increase, or 29%. The increase in general and administrative expenses in the year ended December 31, 2017, was
primarily due to a $521,000 increase in compensation costs primarily associated with a $388,000 increase in stock-based compensation
from new equity grants and an $85,000 increase in salaries from increased headcount and full year compensation costs as compared to the
prior year. In addition, we incurred a $182,000 increase in Legal and Compliance costs primary due to the costs associated with our
uplisting to NASDAQ and the costs associated with our S-3 registration. We expect our general and administrative expenses to remain
relatively constant in the year ending December 31, 2018.
33
Liquidity and Capital Resources
As of December 31, 2017 and 2016, we had $2,823,450 and $3,257,458, respectively, in cash. We maintain our cash in a checking
and a savings account on deposit with a banking institution in the United States. As of December 31, 2017, we had $5,629,009 invested in
U.S. Treasury Bills and Certificates of Deposit. As of December 31, 2017, we had working capital and stockholders’ equity of $7,372,427
and $7,618,913, respectively and incurred a net loss of $9,833,152.
We have not generated any revenues, incurred net losses since inception and do not expect to generate revenues in the near term.
Factors such as these and our projected cash burn raise substantial doubt about our ability to continue as a going concern for at least one
year from the issuance of these financial statements. The Company’s plans, including the raising of debt and equity financing (see Note 13)
and reducing certain operating expenses, alleviated the substantial doubt. We believe that we have sufficient capital to meet our operating
expenses and obligations for the next twelve months from the date of this filing. However, if other unanticipated difficulties arise the
Company may be required to raise additional capital to support its operations, curtail its research and development activities until such time
as additional capital becomes available and delay its target for its upcoming FDA filings and clinical activities. These activities would
necessitate us to slow our rate of spending and extend our use of cash until additional capital is raised. There can be no assurance that such
a plan will be successful. There is no assurance that additional financing will be available when needed or that we will be able to obtain
such financing on reasonable terms.
Cash Flows from Operating Activities
Net cash used in operating activities for the years ended December 31, 2017 and 2016 was $7,634,943 and $5,202,973,
respectively. Cash used in operations for the year ended December 31, 2017 was primarily due to our net loss of $9,833,152 which was
offset by non-cash items of stock based-compensation, depreciation and amortization of the debt discount totaling $1,691,070, an increase
of $388,721 in accounts payable due to the timing of invoices received at the end of the quarter. Cash used in operations for the year ended
December 31, 2016 was primarily due to our net loss of $6,074,999 which was offset by non-cash items of stock based-compensation,
depreciation and amortization of the debt discount totaling $793,603.
Cash Flows from Investing Activities
Net cash used in investing activities for the years ended December 31, 2017 and 2016 was $236,737 and $46,395, respectively.
The cash used in investing activities was due to the timing of the purchases of our investments in certificates of deposit and treasury bills as
compared to the timing of the maturities of those investments. Investing activities for the fiscal year ended December 31, 2016 related to
$88,915 in purchases of property and equipment during the year, offset by the net amount of purchases and redemptions of short-term
highly liquid securities of $58,838.
Cash Flows from Financing Activities
Net cash provided by financing activities for the years ended December 31, 2017 and 2016 was $7,437,672 and $3,703,139,
respectively. Cash provided by financing activities in the year ended December 31, 2017 was primarily due to $5,026,181 in net proceeds
received in a private placement financing completed during the year and the exercise of warrants and employee stock options of $2,616,751,
which was offset by the repayment of a debt obligation to the Alzheimer’s Drug Discovery Foundation of $205,260. Cash provided by
financing activities for the year ended December 31, 2016 was primarily due to the proceeds received from the exercise of common stock
purchase warrants and agent’s unit purchase options of $3,700,539.
34
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements.
Inflation
Inflation did not have a material effect on our business, financial condition or results of operations in 2017 or 2016.
Operating Leases
We are a party to a lease agreement for laboratory space leased on a month-to month basis that is part of a shared facility in Menlo
Park, California. In October 2017, we entered into a one-year lease agreement for office space in Fairfield, New Jersey at a cost of $13,080
per annum.
Rent expense amounted to $236,374 and $171,294 for the years ended December 31, 2017 and 2016, respectively.
Research Loan
In 2013, we were awarded a research loan from the Alzheimer’s Drug Discovery Foundation (“ADDF”) consisting of two
promissory notes totaling $205,260. Through September 30, 2017, the interest rate on each note ranged from 3.25% to 4.0% per annum.
The first installment on the notes matured on January 21, 2017 and was paid in March 2017. The second installment matured and was paid
in full on September 12, 2017. In connection with the award we also issued to the Alzheimer’s Drug Discovery Foundation a warrant to
purchase 15,596 shares of the Company’s common stock at an exercise price of $0.99 per share.
Recent Accounting Pronouncements
See Note 3 to the Financial Statements for the year ended December 31, 2017, for a summary of the relevant recent accounting
pronouncements.
Other recent accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that do not
require adoption until a future date are not expected to have a material impact on the Company’s financial statements upon adoption.
Critical Accounting Estimates
Our management’s discussion and analysis of our financial condition and results of operations are based on our financial
statements, which have been prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP). U.S.
GAAP requires us to make certain estimates and judgments that can affect the reported amounts of assets and liabilities as of the dates of
the financial statements, the disclosure of contingencies as of the dates of the financial statements, and the reported amounts of revenue
and expenses during the periods presented. We base our estimates on historical experience and on various other assumptions that we
believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of
assets and liabilities. If actual results or events differ materially from those contemplated by us in making these estimates, our reported
financial condition and results of operations for future periods could be materially affected. See “Risk Factors” for certain matters that may
affect our future financial condition or results of operations. An accounting policy is deemed to be critical if it requires an accounting
estimate to be made based on assumptions about matters that are uncertain at the time the estimate is made, if different estimates reasonably
could have been used, or if the changes in estimate that are reasonably likely to occur could materially impact the financial statements. Our
management has discussed the development, selection and disclosure of these estimates with the audit committee of our board of directors.
35
The following critical accounting estimates reflect significant judgments and estimates used in the preparation of our financial
statements:
● Fair value of financial instruments
● Share-based payments
● Valuation of deferred tax assets
Fair Value of Financial Instruments
We measure the fair value of financial assets and liabilities based on 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. We utilize three levels of inputs that may be used to measure fair value:
● Level 1 – quoted prices in active markets for identical assets or liabilities
● Level 2 – quoted prices for similar assets and liabilities in active markets or inputs that are observable
● Level 3 – inputs that are unobservable (for example, cash flow modeling inputs based on assumptions)
The carrying amounts of cash, accounts payable, accrued liabilities and debt approximate fair value due to the short-term nature of
these instruments.
Share-based Payments
We account for share-based payments using the fair value method. For employees and directors, the fair value of the award is
measured on the grant date. For non-employees, fair value is generally measured based on the fair value of the services provided or the fair
value of the common stock on the measurement date, whichever is more readily determinable and re-measured at the end of each financial
reporting period until the service is complete. We have historically granted stock options at exercise prices no less than the fair market
value as determined by the board of directors, with input from management.
See Note 3 “Summary of Significant Account Policies – Share-Based Payment” to our Financial Statements for the years ended
December 31, 2017 and 2016 regarding the specific assumptions used with respect to stock-based compensation for the periods presented.
Valuation of deferred tax assets
We recognize deferred tax assets and liabilities for the expected future tax consequences of items that have been included or
excluded in the financial statements or tax returns. Deferred tax assets and liabilities are determined on the basis of the difference between
the tax basis of assets and liabilities and their respective financial reporting amounts (“temporary differences”) at enacted tax rates in effect
for the years in which the temporary differences are expected to reverse.
The benefit of tax positions taken or expected to be taken in income tax returns are recognized in the financial statements if such
positions are more likely than not of being sustained. We have evaluated and concluded that there were no material uncertain tax positions
requiring recognition in the Company’s financial statements as of December 31, 2017 and 2016. The Company does not expect any
significant changes in the unrecognized tax benefits within twelve months of the reporting date.
Item 7A. Quantitative and Qualitative Disclosures about Market Risk
Not applicable.
36
Item 8. Financial Statements
Report of Independent Registered Public Accounting Firm
Balance Sheets as of December 31, 2017 and 2016
Statements of Operations for the Years Ended December 31, 2017 and 2016
Statements of Changes in Stockholders’ Equity for the Years Ended December 31, 2017 and 2016
Statements of Cash Flows for the Years Ended December 31, 2017 and 2016
Notes to Financial Statements
37
Page
38
39
40
41
42
43
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Shareholders and Board of Directors of
CohBar, Inc.
Opinion on the Financial Statements
We have audited the accompanying balance sheets of CohBar, Inc. (the “Company”) as of December 31, 2017 and 2016, the related
statements of operations, changes in stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2017,
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, 2017 and 2016, and the results of its operations and its cash
flows for each of the two years in the period ended December 31, 2017, in conformity with accounting principles generally accepted in the
United States of America.
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 audits 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/ Marcum LLP
Marcum LLP
We have served as the Company’s auditor since 2014.
New York, NY
April 2, 2018
38
CohBar, Inc.
Balance Sheets
ASSETS
Current assets:
Cash
Investments
Subscription receivable
Prepaid expenses and other current assets
Total current assets
Property and equipment, net
Intangible assets, net
Other assets
Total assets
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
Accrued liabilities
Accrued payroll and other compensation
Note payable, net of debt discount of $0 and $59 as of December 31, 2017 and 2016, respectively
Total liabilities
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.001 par value, Authorized 5,000,000 shares; No shares issued and outstanding as of
December 31, 2017 and 2016, respectively
Common stock, $0.001 par value, Authorized 75,000,000 shares; Issued and outstanding 39,439,505
shares as of December 31, 2017 and 34,807,881 as of December 31, 2016
Additional paid-in capital
Accumulated deficit
Total stockholders’ equity
Total liabilities and stockholders’ equity
The accompanying notes are an integral part of these financial statements
39
$
$
$
$
As of December 31,
2016
2017
2,823,450 $
5,629,009
-
164,274
8,616,733
176,531
23,051
46,904
8,863,219 $
3,257,458
5,428,962
522,326
110,822
9,319,568
230,512
-
36,810
9,586,890
492,015 $
249,158
503,133
-
1,244,306
103,294
132,780
447,641
205,201
888,916
-
-
39,440
34,808
31,822,161 23,072,702
(24,242,688) (14,409,536)
8,697,974
9,586,890
7,618,913
8,863,219 $
Revenues
Operating expenses:
Research and development
General and administrative
Total operating expenses
Operating loss
Other income (expense):
Interest income
Interest expense
Amortization of debt discount
Total other income
CohBar, Inc.
Statements of Operations
For The Years Ended
December 31,
2017
2016
$
- $
-
6,675,080
3,184,166
9,859,246
(9,859,246)
3,606,515
2,470,062
6,076,577
(6,076,577)
29,740
(3,587)
(59)
26,094
9,368
(7,594)
(196)
1,578
$ (9,833,152) $ (6,074,999)
(0.18)
$
37,478,883 33,130,424
(0.26) $
Net loss
Basic and diluted net loss per share
Weighted average common shares outstanding - basic and diluted
The accompanying notes are an integral part of these financial statements
40
CohBar, Inc.
Statements of Changes in Stockholders’ Equity
For the Years Ended December 31, 2017 and 2016
Common Stock
Accumulated Stockholders’
Total
Number
Amount
APIC
Deficit
Balance, December 31, 2015
Stock based compensation
Exercise of employee stock options
Exercise of compensation options
Exercise of warrants
Net loss
Balance, December 31, 2016
Stock based compensation
Issuance of common stock
Deferred offering costs
Exercise of employee stock options
Exercise of IPO Warrants
Exercise of warrants
Net loss
Balance, December 31, 2017
32,320,891 $
-
10,000
731,100
1,745,890
-
34,807,881 $
-
3,438,053
-
123,333
926,588
143,650
-
39,439,505 $
-
10
731
1,746
-
32,321 $ 18,114,295 $ (8,334,537) $
-
735,429
-
2,590
-
730,354
3,490,034
-
(6,074,999)
-
34,808 $ 23,072,702 $ (14,409,536) $
-
-
-
-
-
-
(9,833,152)
39,440 $ 31,822,161 $ (24,242,688) $
1,633,485
5,153,642
(130,899)
129,132
1,852,249
111,850
-
-
3,438
-
123
927
144
-
Equity
9,812,079
735,429
2,600
731,085
3,491,780
(6,074,999)
8,697,974
1,633,485
5,157,080
(130,899)
129,255
1,853,176
111,994
(9,833,152)
7,618,913
The accompanying notes are an integral part of these financial statements
41
CohBar, Inc.
Statements of Cash Flows
Cash flows from operating activities:
Net loss
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
Stock-based compensation
Amortization of debt discount
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
Accounts payable
Accrued liabilities
Accrued payroll and other compensation
Net cash used in operating activities
Cash flows from investing activities:
Purchases of property and equipment
Capitalized patent costs
Payment for security deposit
Purchases of investments
Proceeds from redemptions of investments
Net cash used in investing activities
Cash flows from financing activities:
Proceeds from exercise of warrants
Repayment of note payable
Proceeds from exercise of compensation options
Proceeds from stock option exercises
Proceeds from private offering, net
Net cash provided by financing activities
Net decrease in cash
Cash at beginning of year
Cash at end of year
Non-cash investing and financing activities:
Subscription receivable from excercise of warrants
Supplemental disclosure of cash flow information:
Cash paid:
Income taxes paid
Interest paid
The accompanying notes are an integral part of these financial statements
42
For The Years Ended
December 31,
2017
2016
$ (9,833,152) $ (6,074,999)
57,526
1,633,485
59
57,978
735,429
196
(53,452)
388,721
116,378
55,492
(7,634,943)
(22,599)
(106,436)
(22,933)
230,391
(5,202,973)
(3,253)
(23,343)
(10,094)
(88,915)
-
(16,318)
(21,414,722) (14,093,162)
21,214,675 14,152,000
(46,395)
(236,737)
2,487,496
(205,260)
-
129,255
5,026,181
7,437,672
2,969,454
-
731,085
2,600
-
3,703,139
(434,008)
3,257,458
2,823,450 $
(1,546,229)
4,803,687
3,257,458
- $
522,326
2,057 $
29,007 $
1,300
-
$
$
$
$
CohBar, Inc.
Notes to Financial Statements
Note 1 - Business Organization and Nature of Operations
CohBar, Inc. (“CohBar,” “its” or the “Company”) is an innovative biotechnology company and a leader in the research and
development of mitochondria based therapeutics (MBTs), a novel and emerging class of therapeutics that have the potential to treat a wide
range of diseases associated with aging and metabolic dysfunction, including non-alcoholic steatohepatitis (NASH), obesity, type 2
diabetes mellitus (T2D), cancer, atherosclerosis, cardiovascular disease and neurodegenerative diseases such as Alzheimer’s disease.
The Company’s primary activities include research and development of its MBT pipeline, securing intellectual property
protection, managing collaborations with contract research organizations (“CROs”) and academic institutions and raising capital. To date,
the Company has not generated any revenues from operations and does not expect to generate any revenues in the near future. The
Company has financed its operations primarily with proceeds from sales of its equity securities, including its initial public offering (“IPO”),
private placements and the exercise of outstanding warrants and stock options.
Note 2 – Liquidity and Management’s Plans
As of December 31, 2017, the Company had a cash and investments balance of $8,452,459 and working capital and stockholders’
equity of $7,372,427 and $7,618,913, respectively. During the year ended December 31, 2017, the Company incurred a net loss of
$9,833,152. The Company has not generated any revenues, has incurred net losses since inception and does not expect to generate
revenues in the near term. Factors such as these and the Company’s projected cash burn raise substantial doubt about the entity’s ability to
continue as a going concern for at least one year from the issuance of these financial statements. Management’s plans, including the raising
of debt and equity financing (see Note 13) and reducing certain expenses, alleviated the substantial doubt. The Company believes that it
has sufficient capital to meet its operating expenses and obligations for the next twelve months from the date of this filing. However, if
other unanticipated difficulties arise the Company may be required to raise additional capital to support its operations, curtail its research
and development activities until such time as additional capital becomes available and delay its target for its upcoming FDA filings and
clinical activities. These activities would necessitate the Company to slow its rate of spending and extend its use of cash until additional
capital is raised. There can be no assurance that such a plan will be successful. There is no assurance that additional financing will be
available when needed or that the Company will be able to obtain such financing on reasonable terms.
Note 3 - Summary of Significant Accounting Policies
Basis of Presentation
All amounts are presented in U.S. Dollars.
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of
America (“U.S. GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities
and disclosure of contingent liabilities at dates of the financial statements and the reported amounts of revenue and expenses during the
periods. Actual results could differ from these estimates. The Company’s significant estimates and assumptions include the fair value of
financial instruments, stock-based compensation and the valuation allowance relating to the Company’s deferred tax assets.
43
CohBar, Inc.
Notes to Financial Statements
Note 3 - Summary of Significant Accounting Policies (continued)
Concentrations of Credit Risk
The Company maintains deposits in a financial institution which is insured by the Federal Deposit Insurance Corporation
(“FDIC”). At various times, the Company has deposits in this financial institution in excess of the amount insured by the FDIC. The
Company has not experienced any losses in such accounts and believes it is not exposed to any significant credit risk.
Investments
Investments consist of U.S. Treasury Bills of $2,939,401, which are classified as held-to-maturity, and Certificates of Deposit of
$2,689,608. The Company determines the appropriate balance sheet classification of its investments at the time of purchase and evaluates
the classification at each balance sheet date. All of the Company’s U.S. Treasury Bills and Certificates of Deposit mature within the next
twelve months. Unrealized gains and losses are de minimus. As of December 31, 2017, the carrying value of the Company’s U.S. Treasury
Bills approximates their fair value due to their short-term maturities.
Capitalization of Patent Costs
The Company capitalizes the costs of its patents which consists of legal and filing fees related to the prosecution of patent filings.
The patents will be amortized using the straight-line method over the estimated remaining lives of the patents which is 20 years from the
initial filing of the patent. Amortization for the year ended December 31, 2017 was $292.
Cash Equivalents
The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash
equivalents. As of December 31, 2017 and 2016, the Company did not have any cash equivalents.
Property and Equipment
Property and equipment are stated at cost. Depreciation of computer and lab equipment is computed by use of the straight-line
method based on the estimated useful lives of the assets, which range from three to five years. Expenditures for maintenance and repairs
that do not improve or extend the expected lives of the assets are expensed to operations, while expenditures for major upgrades to existing
items are capitalized. Upon retirement or other disposition of these assets, the costs and accumulated depreciation are removed from the
accounts and resulting gains or losses are reflected in the results of operations.
44
CohBar, Inc.
Notes to Financial Statements
Note 3 - Summary of Significant Accounting Policies (continued)
Fair Value of Financial Instruments
The Company measures the fair value of financial assets and liabilities based on 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. The Company utilizes three levels of inputs that may be used to measure
fair value:
Level 1 - quoted prices in active markets for identical assets or liabilities
Level 2 - quoted prices for similar assets and liabilities in active markets or inputs that are observable
Level 3 - inputs that are unobservable (for example, cash flow modeling inputs based on assumptions)
The carrying amounts of cash and accounts payable approximate fair value due to the short-term nature of these instruments. The
amount of debt included in the accompanying balance sheets approximates its fair value because the interest rate of the notes approximates
the current market interest rate.
Common Stock Purchase Warrants
The Company classifies as equity any contracts that (i) require physical settlement or net-share settlement or (ii) provides the
Company with a choice of net-cash settlement or settlement in its own shares (physical settlement or net-share settlement) providing that
such contracts are indexed to the Company’s own stock. The Company classifies as assets or liabilities any contracts that (i) require net-
cash settlement (including a requirement to net cash settle the contract if an event occurs and if that event is outside the Company’s control),
or (ii) gives the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement). The
Company assesses classification of its common stock purchase warrants and other free-standing derivatives at each reporting date to
determine whether a change in classification between assets, liabilities and equity is required. The Company’s free-standing derivatives
consist of warrants to purchase common stock that were issued in connection with its notes payable and private offering. The Company
evaluated these warrants to assess their proper classification using the applicable criteria enumerated under U.S. GAAP and determined that
the common stock purchase warrants meet the criteria for equity classification in the accompanying balance sheets as of December 31,
2017 and 2016.
Income Taxes
The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of items that have been
included or excluded in the financial statements or tax returns. Deferred tax assets and liabilities are determined on the basis of the
difference between the tax basis of assets and liabilities and their respective financial reporting amounts (“temporary differences”) at
enacted tax rates in effect for the years in which the temporary differences are expected to reverse.
The benefit of tax positions taken or expected to be taken in income tax returns are recognized in the financial statements if such
positions are more likely than not of being sustained. Management has evaluated and concluded that there were no material uncertain tax
positions requiring recognition in the Company’s financial statements as of December 31, 2017 and 2016. The Company does not expect
any significant changes in the unrecognized tax benefits within twelve months of the reporting date.
The Company classifies interest expense and any related penalties related to income tax uncertainties as a component of income
tax expense. No interest or penalties have been recognized during the years ended December 31, 2017 and 2016.
45
CohBar, Inc.
Notes to Financial Statements
note 3 - Summary of Significant Accounting Policies (continued)
Research and Development Expenses
The Company expenses all research and development expenses as incurred. These costs include payroll, employee benefits,
supplies, contracted for lab services, depreciation and other personnel-related costs associated with product development.
Share-Based Payment
The Company accounts for share-based payments using the fair value method. For employees and directors, the fair value of the
award is measured, as discussed below, on the grant date. For non-employees, fair value is generally valued based on the fair value of the
services provided or the fair value of the equity instruments on the measurement date, whichever is more readily determinable and re-
measured on each financial reporting date until the service is complete. The Company has granted stock options at exercise prices equal to
the higher of (i) the closing price of the Company’s common stock as reported on the OTCQX marketplace, (ii) the closing price of the
Company’s common stock as reported by the TSX Venture Exchange or (iii) the closing price of the Company’s common stock as reported
by NASDAQ as determined by the board of directors, with input from management on the date of grant. Upon exercise of an option or
warrant, the Company issues new shares of common stock out of its authorized shares.
The weighted-average fair value of options and warrants has been estimated on the grant date or measurement date using the
Black-Scholes pricing model. The fair value of each instrument is estimated on the grant date or measurement date utilizing certain
assumptions for a risk-free interest rate, volatility and expected remaining lives of the awards. Since the Company has a limited history of
being publicly traded, the fair value of stock-based payment awards issued was estimated using a volatility derived from an index of
comparable entities. The assumptions used in calculating the fair value of share-based payment awards represent management’s best
estimates, but these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and
the Company uses different assumptions, the Company’s stock-based compensation expense could be materially different in the future. In
addition, the Company is required to estimate the expected forfeiture rate and only recognize expense for those shares expected to vest. In
estimating the Company’s forfeiture rate, the Company analyzed its historical forfeiture rate, the remaining lives of unvested options, and
the number of vested options as a percentage of total options outstanding. If the Company’s actual forfeiture rate is materially different
from its estimate, or if the Company reevaluates the forfeiture rate in the future, the stock-based compensation expense could be
significantly different from what the Company has recorded in the current period.
The weighted-average Black-Scholes assumptions are as follows:
Expected life
Risk free interest rate
Expected volatility
Expected dividend yield
Forfeiture rate
46
For the Years Ended
December 31,
2017
2016
7 years
6 years
2.23%
80%
0%
0%
1.31%
79%
0%
0%
CohBar, Inc.
Notes to Financial Statements
Note 3 - Summary of Significant Accounting Policies (continued)
As of December 31, 2017, total unrecognized stock option compensation expense is $2,175,601, which will be recognized as those
options vest over a period of approximately four years. The amount of future stock option compensation expense could be affected by any
future option grants or by any option holders leaving the Company before their grants are fully vested.
Net Loss Per Share of Common Stock
Basic net loss per share is computed by dividing net loss attributable to common stockholders by the weighted average number of
common shares outstanding during the period. Diluted net earnings per share reflects the potential dilution that could occur if securities or
other instruments to issue common stock were exercised or converted into common stock. Potentially dilutive securities are excluded from
the computation of diluted net loss per share as their inclusion would be anti-dilutive and consist of the following:
Options
Warrants
Totals
Recent Accounting Pronouncements
As of December 31,
2016
2017
5,691,414
4,652,497
6,681,051
4,533,020
10,224,434 11,333,548
In May 2017, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2017-
09, Compensation - Stock Compensation (Topic 718): Scope of Modification Accounting, which clarifies what constitutes a modification of
a share-based payment award. The ASU is intended to provide clarity and reduce both diversity in practice and cost and complexity when
applying the guidance in Topic 718 to a change to the terms or conditions of a share-based payment award. ASU 2017-09 is effective for
public entities for annual periods beginning after December 15, 2017, and interim periods within those fiscal years. The Company does not
anticipate that the adoption of ASU 2017-09 will have a material impact on its financial condition or results of operations.
In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230), which simplifies certain elements of
cash flow classification. The new guidance is intended to reduce diversity in practice in how certain transactions are classified in the
statement of cash flows. The new guidance will be effective for annual periods beginning after December 15, 2017. The Company does not
anticipate that the adoption of ASU 2016-15 will have a material impact on its financial condition or results of operations.
In March 2016, the FASB issued ASU No. 2016-09, Compensation—Stock Compensation (Topic 718): Improvements to
Employee Share-Based Payment Accounting. This ASU simplifies several aspects of the accounting for share-based payment transactions,
including the income tax consequences, classification of awards as either equity or liabilities and classification on the statement of cash
flows. This ASU is effective for annual periods beginning after December 15, 2016, and interim periods within those annual periods. The
Company adopted this guidance as of January 1, 2017 and elected to account for forfeitures in the period they occur. The adoption of ASU
No. 2016-09 did not have a material impact on the Company’s results of operations.
47
CohBar, Inc.
Notes to Financial Statements
Note 4 - Property and Equipment
Property and equipment consist of the following:
Lab equipment
Computer and equipment
Total property and equipment
Less: accumulated depreciation
Total property and equipment, net
As of December 31,
2016
2017
$
$
309,007 $
20,123
329,130
(152,599)
176,531 $
304,499
21,378
325,877
(95,365)
230,512
Depreciation expense related to property and equipment for the years ended December 31, 2017 and 2016 was $57,234 and
$57,978, respectively. During the year ended December 31, 2017, the Company wrote off fully depreciated assets and adjusted the carrying
value of the assets and accumulated depreciation by $8,891, respectively.
Note 5 – Intangible Assets
Intangible assets consist of the following:
Intangible assets: patents
Less: amortization
Total intangible assets, net
Amortization expense for the year ended December 31, 2017 was $292.
Note 6 – Accrued Liabilities
Accrued liabilities consist of the following:
Lab services & supplies
Professional fees
Consultant fees
Interest
Total accrued liabilities
48
As of December 31,
2016
2017
$
$
23,343 $
(292)
23,051 $
-
-
-
As of December 31,
2016
2017
11,477 $
235,181
2,500
-
249,158 $
87,100
17,760
2,500
25,420
132,780
$
$
CohBar, Inc.
Notes to Financial Statements
Note 7 - Note Payable
In 2013, the Company was awarded a grant from the Alzheimer’s Drug Discovery Foundation consisting of two promissory notes
totaling $205,260. The notes had original terms of four years and were paid in full in 2017.
Note 8 - Commitments and Contingencies
Litigations, Claims and Assessments
The Company may from time to time be a party to litigation and subject to claims incident to the ordinary course of business. As
the Company grows and gains prominence in the marketplace it may become a party to an increasing number of litigation matters and
claims. The outcome of litigation and claims cannot be predicted with certainty, and the resolution of these matters could materially affect
the Company’s future results of operations, cash flows or financial position. The Company is not currently a party to any legal proceedings.
Licensing Agreements
The Company is a party to an Exclusive License Agreement (the “2011 Exclusive Agreement”) with The Regents of the
University of California (“The Regents” or “Licensors”) which remains in effect for the life of the last-to-expire patent or last to be
abandoned patent application, whichever is later. The Company agreed to pay the Licensors specified development milestone payments
aggregating up to $765,000 for the first product sold under the license. Milestone payments for additional products developed and sold
under the license are reduced by 50%. The Company is also required to pay annual maintenance fees to the Licensors. Aggregate
maintenance fees for the first five years following execution of the agreement are $80,000. Thereafter, the Company is required to pay
maintenance fees of $50,000 annually until the first sale of a licensed product. In addition, for the duration of the 2011 Exclusive
Agreement, the Company is required to pay the Licensors royalties equal to 2% of its worldwide net sales of drugs, therapies or other
products developed from claims covered by the licensed patents, subject to a minimum royalty payment of $75,000 annually, beginning
after the first commercial sale of a licensed product. The Company is required to pay royalties ranging from 8% of worldwide sublicense
sales of covered products (if the sublicense is entered after commencement of phase II clinical trials to 12% of worldwide sublicense sales
(if the sublicense is entered prior to commencement of phase I clinical trials). The agreement also requires the Company to meet certain
diligence and development milestones, including filing of an Investigational New Drug (“IND”) Application for a product covered by the
agreement on or before the seventh anniversary of the agreement date. Through December 31, 2017, no royalties have been incurred under
the agreement. All maintenance fees due and payable as of that date have been paid.
The Company is also a party to an Exclusive License Agreement (the “2013 Exclusive Agreement”) with The Regents whereby
The Regents granted to the Company an exclusive license for the use of certain other patents. The 2013 Exclusive Agreement remains in
effect for the life of the last-to-expire patent or last to be abandoned patent application, whichever is later. The Company paid The Regents
an initial license issue fee of $10,000 for these other patents, which was charged to General and Administrative expense, as incurred. The
Company is also required to pay annual maintenance fees to the Licensors. Aggregate maintenance fees for the first three years following
execution of the agreement are $7,500. Thereafter, the Company is required to pay maintenance fees of $5,000 annually until the first sale
of a licensed product. The Company agreed to pay The Regents specified development milestone payments aggregating up to $765,000 for
the first product sold under the 2013 Exclusive Agreement. Milestone payments for additional products developed and sold under the 2013
Exclusive Agreement are reduced by 50%. In addition, for the duration of the 2013 Exclusive Agreement, the Company is required to pay
The Regents royalties equal to 2% of the Company’s worldwide net sales of drugs, therapies or other products developed from claims
covered by the licensed patent, subject to a minimum royalty payment of $75,000 annually, beginning after the first commercial sale of a
licensed product. The Company is required to pay The Regents royalties ranging from 8% of worldwide sublicense sales of covered
products (if the sublicense is entered after commencement of phase II clinical trials to 12% of worldwide sublicense sales (if the sublicense
is entered prior to commencement of phase I clinical trials). The agreement also requires the Company to meet certain diligence and
development milestones, including filing of an IND Application for a product covered by the agreement on or before the seventh
anniversary of the agreement date. Through December 31, 2017, no royalties have been incurred under the agreement. All maintenance
fees due and payable as of that date have been paid.
49
CohBar, Inc.
Notes to Financial Statements
Note 8 - Commitments and Contingencies (continued)
Operating Leases
The Company is a party to a lease agreement for laboratory space leased on a month-to month basis that is part of a shared facility
in Menlo Park, California. In October 2017, the Company entered into a one-year lease agreement for office space in Fairfield, New Jersey
at a cost of $13,080 per annum.
Rent expense amounted to $236,374 and $171,294 for the years ended December 31, 2017 and 2016, respectively.
Note 9 - Income Taxes
The tax effects of temporary differences that give rise to deferred tax assets are as follows:
Current:
Accrued expenses
Non-current:
Stock compensation
Net operating loss carryforward
Research and development credit carry forward
Total deferred tax assets
Valuation allowance
Deferred tax asset, net of valuation allowance
50
As of December 31,
2016
2017
$
23,595 $
51,174
359,364
5,656,895
417,882
6,457,736
(6,457,736)
- $
163,221
5,058,119
267,325
5,539,839
(5,539,839)
-
$
CohBar, Inc.
Notes to Financial Statements
Note 9 - Income Taxes (continued)
A reconciliation of the statutory federal income tax rate to the Company’s effective tax rate is as follows:
U.S. statutory federal rate
State income taxes, net of federal tax
Federal tax rate change
Permanent differences
Prior year true-ups
R&D tax credit
Change in valuation allowance
Income tax provision (benefit)
The income tax provision consists of the following:
Federal
Current
Deferred
State and local
Current
Deferred
Change in valuation allowance
Income tax provision (benefit)
For the Years Ended
December 31,
2017
2016
(34.0)%
(5.4)%
28.3%
2.2%
0.4%
(0.8)%
9.3%
-%
(34.0)%
(5.1)%
-%
4.2%
-%
(2.7)%
37.6%
-%
For the Years Ended
December 31,
2017
2016
$
- $
(718,326)
-
(1,815,660)
-
(199,571)
917,897
- $
-
(470,263)
2,285,923
-
$
The Company assesses the likelihood that deferred tax assets will be realized. To the extent that realization is not more-likely-
than-not, a valuation allowance is established. Based upon the Company’s losses since inception, management believes that it is more-
likely-than-not that future benefits of deferred tax assets will not be realized. Therefore, the Company established a full valuation
allowance as of December 31, 2017 and 2016. As of December 31, 2017 and 2016, the change in valuation allowance was $917,897 and
$2,285,923, respectively.
The Company files income tax returns in the U.S. federal jurisdiction and various state jurisdictions, principally California and New
Jersey. The Company is subject to examination by the various taxing authorities. The Company’s federal and state income tax returns for
tax years beginning in 2013 remain subject to examination.
At December 31, 2017 and 2016, the Company had approximately $21,000,000 and $13,000,000, respectively, of federal and state
net operating loss carryovers that may be available to offset future taxable income. The net operating loss carry forwards, if not utilized,
will begin to expire from 2029 to 2036 for federal and state purposes. In accordance with Section 382 of the Internal Revenue Code, the
usage of the Company’s net operating loss carryforward could be limited in the event of a change in ownership. At this time, the Company
has not completed a full study to assess whether an ownership change under Section 382 of the Code occurred due to the costs and
complexities associated with such a study.
51
CohBar, Inc.
Notes to Financial Statements
Note 9 - Income Taxes (continued)
On December 22, 2017, new legislation was signed into law, informally titled the Tax Cuts and Jobs Act, which included, among
other things, a provision to reduce the federal corporate income tax rate to 21%. Under ASC 740, Accounting for Income Taxes, the
enactment of the Tax Act also requires companies, to recognize the effects of changes in tax laws and rates on deferred tax assets and
liabilities and the retroactive effects of changes in tax laws in the period in which the new legislation is enacted. There is no further change
to its assertion on maintaining a full valuation allowance against its U.S. deferred tax assets. The Company’s gross deferred tax assets have
been revalued from 34% to 21% with a corresponding offset to the valuation allowance and any potential other taxes arising due to the Tax
Act will result in reductions to its net operating loss carryforward and valuation allowance. Deferred tax assets of approximately
$9,200,000 have been revalued to approximately $6,500,000 with a corresponding decrease to the Company’s valuation allowance.
Therefore, there was no net impact on the Company’s financial statements for the year ended December 31, 2017.
On December 22, 2017, the SEC Staff issued Staff Accounting Bulletin No. 118 (“SAB 118”) to address the application of ASC
Topic 740 in situations when a registrant does not have the necessary information available, prepared, or analyzed in reasonable detail to
complete the accounting for certain income tax effects of the Act. The Company is complete with its accounting for the effects of the Tax
Act, however, as additional guidance and interpretation may be issued by the U.S. Treasury Department, the IRS and other standard setting
bodies, the Company may be required to make adjustment and/or additional disclosure relating to its gross deferred tax assets in 2018.
Note 10 - Stockholders’ Equity
Authorized Capital
The Company has authorized the issuance and sale of up to 80,000,000 shares of stock, consisting of 75,000,000 shares of
common stock having a par value of $0.001 and 5,000,000 shares of Preferred Stock having a par value of $0.001 per share. As of
December 31, 2017 and 2016, there were no shares of Preferred Stock outstanding and there were no declared but unpaid dividends or
undeclared dividend arrearages on any shares of the Company’s capital stock.
Private Offering
During the year ended December 31, 2017, the Company completed a private offering for total net proceeds of approximately
$5.02 million (“Private Offering”), of which 289,334 units were sold to officers and directors. The Company issued an aggregate of
3,438,053 units at a price of $1.50 per unit. Each unit consists of one share of the Company’s common stock and one common stock
purchase warrant (see “Warrants”). Each warrant can be exercised at any time prior to June 30, 2020 for the purchase of one share of the
Company’s common stock at an exercise price of $2.25.
Stock Options
The Company has an incentive stock plan, the Amended and Restated 2011 Equity Incentive Plan (the “2011 Plan”), and has
granted stock options to employees, non-employee directors and consultants from the 2011 Plan. Options granted under the 2011 Plan may
be Incentive Stock Options or Non-statutory Stock Options, as determined by the Administrator at the time of grant. The rules of the TSX
Venture Exchange (or “TSX-V”) provide that the maximum number of shares which can be reserved under a stock option plan is equal to
20% of the number of shares of the issuer which are outstanding on the date the plan is approved by stockholders. On June 15, 2017, the
Company’s stockholders approved an amendment to the 2011 Plan to increase the number of shares authorized for issuance under the 2011
Plan to a total of 7,171,540, which is equal to 20% of the number of shares of the Company’s common stock outstanding on the date of the
amendment. At December 31, 2017, 1,041,793 shares of the Company’s common stock were available for future issuance under the 2011
Plan.
52
CohBar, Inc.
Notes to Financial Statements
Note 10 - Stockholders’ Equity (continued)
During the year ended December 31, 2017, the Company granted stock options to employees to purchase 1,031,000 shares of the
Company’s common stock at an exercise price of $2.40 per share. The options have terms of ten years. Of the 1,031,000 stock options
granted, 300,000 are subject to vesting based on continuous service over periods between zero and four years from the date of grant. The
balance of the grant, or 731,000 shares, has performance-based vesting conditions and will be valued at the time the milestones are
reached. The stock options have an aggregate grant date fair value of $528,580.
During the year ended December 31, 2017, the Company granted stock options to two consultants to purchase a total of 85,000
shares of the Company’s common stock. The stock options have an exercise price of $2.02 per share and are exercisable during a ten-year
term, are subject to vesting over periods of three and four years and have an aggregate measurement date fair value of $269,416.
During the year ended December 31, 2017, the Company granted stock options to a new member of its Board of Directors to
purchase 200,000 shares of the Company’s common stock. The stock options have an exercise price of $4.60 per share and are exercisable
during a ten-year term, are subject to vesting over four years and have an aggregate grant date fair value of $719,360.
In January 2016, the Company issued a warrant to purchase 125,000 shares of the Company’s common stock to an investor
relations firm as partial compensation for consulting services it would provide the Company over a two-year period. In August 2017, the
Company issued warrants to purchase 180,000 shares of the Company’s common stock to two consultants as compensation for consulting
services they will provide the Company over a five-year period. Pursuant to applicable policies of the TSX-V, the shares issuable under the
warrants will be counted against the limit of shares authorized for issuance under the 2011 Plan, notwithstanding that the warrants were not
issued under the 2011 Plan. After giving effect to this limitation there were 1,041,793 shares remaining available for issuance under the
2011 Plan at December 31, 2017.
During the year ended December 31, 2017, 123,333 stock options were exercised for cash proceeds of $129,255 and the Company
cancelled 153,750 stock options.
During the year ended December 31, 2016, the Company granted stock options to employees to purchase 1,696,000 shares of the
Company’s common stock. The stock options have exercise prices that range from $1.10 to $1.55 per share, are subject to vesting over four
years, have terms of ten years and have an aggregate grant date fair value of approximately $1,418,000.
During the year ended December 31, 2016, 10,000 stock options were exercised for cash proceeds of $2,600 and 26,486 were
cancelled.
The Company recorded stock-based compensation as follows:
Research and development
General and administrative
Total
53
For the Years Ended
December 31,
2017
2016
$
$
884,032 $
749,453
1,633,485 $
374,292
361,137
735,429
CohBar, Inc.
Notes to Financial Statements
Note 10 - Stockholders’ Equity (continued)
The following table represents stock option activity for the years ended December 31, 2017 and 2016:
Weighted Average
Stock Options
Exercise Price
Outstanding Exercisable Outstanding Exercisable Vested
Fair Value Contractual
Life (Years)
Aggregate
Intrinsic
Value
Balance – December 31, 2015
Granted
Exercised
Cancelled
Balance – December 31, 2016
Granted
Exercised
Cancelled
Balance – December 31, 2017
3,724,083
1,696,000
(741,100)
(26,486)
4,652,497
1,316,000
(123,333)
(153,750)
5,691,414
1,963,948 $
-
-
-
1,908,883 $
-
-
-
3,124,941 $
0.67 $
1.50
-
-
0.92 $
-
-
-
1.16 $
0.34 $
-
-
-
0.41 $
-
-
-
0.73 $
0.34
-
-
-
0.41
-
-
-
0.73
7.09 $
6.25
-
-
8.24 $
-
-
-
-
-
-
-
-
-
-
-
6.87 $ 19,142,175
The following table summarizes information on stock options outstanding and exercisable as of December 31, 2017:
Exercise
Price
Number
Outstanding
Weighted
Average
Remaining
Contractual Term
Weighted
Average
Exercise Price
Number
Exercisable
$
$
$
$
$
$
$
$
$
$
$
$
Totals
0.05
0.26
0.73
1.00
1.10
1.17
1.22
1.50
1.55
2.02
2.40
4.60
52,876
1,024,810
1,475,687
313,124
8,000
51,605
70,312
28,000
1,456,000
85,000
926,000
200,000
5,691,414
Agent’s Compensation Options
4.25 years
6.28 years
6.87 years
7.56 years
8.02 years
7.87 years
8.10 years
8.17 years
8.19 years
9.61 years
9.08 years
9.94 years
$
$
$
$
$
$
$
$
$
$
$
$
0.05
0.26
0.73
1.00
1.10
1.17
1.22
1.50
1.55
2.02
2.40
4.60
52,876
1,022,536
1,137,509
206,457
3,209
22,230
5,208
6,333
495,250
33,750
139,583
-
3,124,941
In connection with the closing of its IPO in January 2015 the Company issued 786,696 compensation options (“Compensation
Options”) to the agents that took part in the offering. Each Compensation Option is exercisable for a unit consisting of one share of
common stock and one-half of one common stock purchase warrant at an exercise price of $1.00 per unit. The Compensation Options
expired on July 6, 2016. Each whole warrant issuable upon exercise of Compensation Options is exercisable to acquire one share of
common stock at an exercise price of $2.00 per share at any time up to January 6, 2017. Because the Compensation Options are considered
a cost of the IPO, the resulting value is recognized as both an increase and decrease to the equity section of the accompanying balance
sheets. The Compensation Options are not part of the Company’s 2011 Plan.
During the year ended December 31, 2016, a total of 731,100 Compensation Options were exercised for cash proceeds of
$731,100.
54
CohBar, Inc.
Notes to Financial Statements
Note 10 - Stockholders’ Equity (continued)
Warrants
In January 2017, a total of 926,588 common stock purchase warrants were exercised for aggregate cash proceeds of $1,853,176.
Additional proceeds in the amount of $522,326 were received in January 2017 from warrants exercised in December 2016. During the year
ended December 31, 2017, 4,695,846 unexercised warrants expired.
During the year ended December 31, 2017, a total of 143,650 warrants were exercised for aggregate cash proceeds of $111,994.
During the year ended December 31, 2017, the Company issued warrants to two consultants. The warrants are exercisable any
time prior to August 7, 2022 for the purchase of an aggregate of 180,000 shares of common stock at an exercise price of $1.99 per share.
In January 2016, the Company issued a warrant to purchase 125,000 shares of the Company’s common stock to an investor
relations firm as partial compensation for consulting services to be provided over a two-year period. The warrant is exercisable at $1.15
per share, has a term of three years and is subject to vesting over the two-year service period.
During the year ended December 31, 2016, the Company issued warrants to purchase an aggregate of 365,550 shares of common
stock as a result of the exercise of 731,100 Compensation Options.
During the year ended December 31, 2016, a total of 1,745,890 warrants were exercised for cash proceeds of $2,969,454 (see Note
11 - Subscription Receivable).
The following table represents warrant activity for the years ended December 31, 2017 and 2016:
Weighted Average
Warrants
Exercise Price
Outstanding Exercisable Outstanding Exercisable
Fair Value Contractual
Life (Years)
Vested
Aggregate
Intrinsic
Value
Balance – December 31, 2015
Granted
Exercised
Cancelled
Balance – December 31, 2016
Granted
Exercised
Cancelled
Balance – December 31, 2017
7,936,391
490,550
(1,745,890)
-
6,681,051
3,618,053
(1,070,238)
(4,695,846)
4,533,020
7,936,391 $
428,050
(1,745,890)
-
6,618,551 $
-
-
-
4,517,395 $
1.80 $
-
-
-
1.74 $
-
-
-
1.85 $
1.80 $
-
-
-
1.74 $
-
-
-
1.85 $
0.41
-
-
-
0.41
-
-
-
1.00
1.80 $
-
-
-
0.98 $
-
-
-
-
-
-
-
-
-
-
-
3.21 $ 14,280,372
Note 11 – Subscription Receivable
During December 2016, a total of 261,163 warrants were exercised for cash proceeds of $522,326. Due to the timing of the
exercises, the shares underlying the warrants were issued in December 2016 and the proceeds were received in January 2017. The
outstanding proceeds were recorded as a Subscription Receivable in the accompanying balance sheets as of December 31, 2016.
55
CohBar, Inc.
Notes to Financial Statements
Note 12 - Related Party Transactions
Two of the Company’s Directors provide consulting, scientific and research and advisory services to the Company pursuant to
agreements that provided for annual compensation of $42,000 each. During the fourth quarter of the year ended December 31, 2017, the
Company modified the compensation terms under the agreements. The Company will continue to compensate Dr. Cohen and Dr. Barzilai
for their ongoing consulting, scientific and research and advisory services at an annual rate of $20,000 per individual. In addition, both Dr.
Barzilai and Dr. Cohen will receive a fee for serving on the Company’s Board of Directors. During each of the years ended December 31,
2017 and 2016, $36,500 and $42,000, respectively, was paid to each director by the Company for consulting fees. As of December 31, 2017
and 2016, no amounts were owed to either Director.
Note 13 - Subsequent Events
Management has evaluated subsequent events to determine if events or transactions occurring through the date on which the
financial statements were issued require adjustment or disclosure in the Company’s financial statements.
Subsequent to December 31, 2017, the Company issued Promissory Notes (the “Notes”) totaling $2,142,500. The Notes bear
interest at the rate of 8% interest per annum and mature on March 29, 2021. The purchasers of the Notes also received warrants to purchase
an aggregate of 428,500 shares of the Company’s common stock. The warrants are exercisable any time prior to March 29, 2021, subject to
acceleration of the expiry date in certain circumstances, at an exercise price of $5.30 per share.
Subsequent to December 31, 2017, the Company granted stock options to its employees to purchase a total of 280,000 shares of the
Company’s common stock. The stock options have an exercise price of $5.30 per share and are exercisable during a ten year term subject
to vesting periods that range from zero to four years.
Subsequent to December 31, 2017, a total of 267,333 warrants were exercised for cash proceeds of $588,499 and 249,309 stock
options were exercised for cash proceeds of $146,438.
56
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
An evaluation was conducted under the supervision and with the participation of our management, including Simon Allen, our
Chief Executive Officer, and Jeff Biunno, our Chief Financial Officer (collectively, the “Certifying Officers”), of the effectiveness of our
disclosure controls and procedures as of December 31, 2017, as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of
1934 (the “Exchange Act”). Based on that evaluation, our management concluded that, during the period covered by this annual report, our
disclosure controls and procedures were not effective due to a material weakness.
Management’s Report on Internal Control over Financial Reporting
Management is responsible for establishing and maintaining adequate internal control over financial reporting as such term is
defined in Rule 13a-15(f) and 15(d)-15(f) under the Exchange Act. This rule defines internal control over financial reporting as a process
designed by, or under the supervision of, Certifying Officers, to provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance with U.S. GAAP. Our internal control over financial
reporting includes those policies and procedures that:
● pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of
our assets;
● provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in
accordance with U.S. GAAP, and that receipts and expenditures are being made only in accordance with authorizations of our
management and directors; and
● 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 financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. In addition,
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 the policies or procedures may deteriorate.
Management’s Assessment
Our management, including our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our internal
control over financial reporting based on the criteria established in Internal Control - Integrated Framework (2013), issued by the
Committee of Sponsoring Organizations of the Treadway Commission. As previously disclosed, management concluded that our internal
control over financial reporting was not effective due to a material weakness. The material weakness relates to our having primarily one
employee throughout most of 2017 assigned to positions that involve processing financial information, resulting in a lack of segregation of
duties so that all journal entries and account reconciliations are reviewed by someone other than the preparer, heightening the risk of error
or fraud. During the fourth quarter of 2017, remedial actions were implemented to address this material weakness. We hired additional
qualified financial staff and implemented procedures to segregate duties to ensure that journal entries and account reconciliations are
reviewed by someone other than the preparer. Additional procedures have been implemented to further strengthen our controls over
financial reporting.
57
Although management believes that the controls implemented during the period are sufficient, we have concluded that such
controls have not been in place for a sufficient period of time in order to conclude that the identified material weakness described above has
been fully remediated. Therefore, based on this evaluation, the Chief Executive Officer and Chief Financial Officer have concluded that as
of December 31, 2017, our internal control over financial reporting was not effective.
We have limited capital resources and have given priority in the use of those resources to our research and development efforts. If
we are unable to maintain effective internal control over financial reporting, we may not be able to report our financial results accurately,
prevent fraud or file our periodic reports in a timely manner. We continue to evaluate the effectiveness of our internal controls and
procedures on an on-going basis. As our operations continue to grow and become more complex, we intend to hire additional personnel in
financial reporting and other areas.
Auditor Attestation
This Annual Report on Form 10-K does not include an attestation of our registered public accounting firm regarding internal control
over financial reporting. Management’s report was not subject to attestation by our registered public accounting firm pursuant to applicable
rules of the Securities and Exchange Commission.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting during the last fiscal quarter that have materially affected,
or are reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information
None.
58
Item 10. Directors, Executive Officers and Corporate Governance
PART III
The information required by this item will be set forth under the captions Election of Directors, Section 16(a) Beneficial
Ownership Reporting Compliance, Executive Officers, Information Concerning the Board of Directors and Code of Ethics in our definitive
Proxy Statement for our 2018 Annual Meeting of Shareholders to be filed with the SEC by April 30, 2018 (“Proxy Statement”). If the
Proxy Statement is not filed with the SEC by April 30, 2018, such information will be included in an amendment to this Annual Report on
Form 10-K filed by April 30, 2018.
Item 11. Executive Compensation
The information required by this item will be set forth under the captions Executive Compensation and Director Compensation in
our definitive Proxy Statement for our 2018 Annual Meeting of Shareholders to be filed with the SEC by April 30, 2018. If the Proxy
Statement is not filed with the SEC by April 30, 2018, such information will be included in an amendment to this Annual Report on Form
10-K filed by April 30, 2018.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Equity Compensation Plan Information
The following table provides information about our equity compensation plan as of December 31, 2017:
Number of
securities
remaining
available for
future
issuance
under equity
compensation
plans
(excluding
securities
reflected in
column (a))
(b)
1,041,793
-
1,041,793
Number of
securities to
be issued
upon exercise
of options
warrants and
rights (a)
Weighted-
average
exercise price
of outstanding
options
warrants and
rights
(b)
5,996,414
$
4,228,020(1) $
$
10,224,434
0.76
1.86
0.65
Plan Category
Equity compensation plans approved by stockholders
Equity compensation plans not approved by stockholders
Total
(1) Consists of warrants issued to our Chief Executive Officer pursuant to an employment agreement, two consultants pursuant to
consulting agreements, warrants issued in 2014 related to a bridge loan, warrants issued to the ADDF for the 2013 grant and
warrants issued in 2017 from our private placement.
Beneficial Ownership
The information required by this item is included under the caption Security Ownership of Certain Beneficial Owners and
Management in our definitive Proxy Statement for our 2018 Annual Meeting of Shareholders to be filed with the SEC by April 30, 2018. If
the Proxy Statement is not filed with the SEC by April 30, 2018, such information will be included in an amendment to this Annual Report
on Form 10-K filed by April 30, 2018.
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information required by this item is included under the caption Information Concerning the Board of Directors in our
definitive Proxy Statement for our 2017 Annual Meeting of Shareholders to be filed with the SEC by April 30, 2018 (“Proxy Statement”).
If the Proxy Statement is not filed with the SEC by April 30, 2018, such information will be included in an amendment to this Annual
Report on Form 10-K filed by April 30, 2018.
Item 14. Principal Accounting Fees and Services
The information required by this item is included under the caption Ratification of Appointment of Registered Independent Public
Accounting Firm in our definitive Proxy Statement for our 2018 Annual Meeting of Shareholders to be filed with the SEC by April 30,
2018. If the Proxy Statement is not filed with the SEC by April 30, 2018, such information will be included in an amendment to this Annual
Report on Form 10-K filed by April 30, 2018.
59
Item 15. Exhibits and Financial Statement Schedules
PART IV
Financial statement schedules have been omitted because they are not applicable or the required information is shown in the
financial statements or notes thereto.
Item 16. Form 10-K Summary
Not applicable.
60
The following exhibits are filed herewith and this list is intended to constitute the exhibit index.
Exhibit No.
Description
Exhibits
3.1
3.2
Third Amended and Restated Articles of Incorporation - Incorporated by reference to Exhibit 3.1 of our Current Report on
Form 8-K, as filed with the Commission on January 8, 2015.
Amended and Restated Bylaws - Incorporated by reference to Exhibit 3.2 of our Current Report on Form 8-K, as filed with
the Commission on January 8, 2015.
10.1*
Amended and Restated 2011 Equity Incentive Plan - Incorporated by reference to Exhibit 10.1 of our Current Report on Form
8-K, as filed with the Commission on January 8, 2015.
10.2*
First Amendment to Amended and Restated 2011 Equity Incentive Plan - Incorporated by reference to Exhibit 10.1 of our
Quarterly Report on Form 10-Q, as filed with the Commission on August 24, 2017.
10.3*
Form of Option Agreement under the 2011 Equity Incentive Plan -- Incorporated by reference to Exhibit 10.2 to our
Registration Statement on Form S-1 (File No. 333-200033) as filed with the Commission on November 10, 2014.
10.4
10.5
Exclusive License Agreement, dated August 6, 2013, between CohBar, Inc. and the Regents of the University of California -
Incorporated by reference to Exhibit 10.4 to our Registration Statement on Form S-1 (File No. 333-200033) as filed with the
Commission on November 10, 2014.
Exclusive License Agreement, dated November 3, 2011, between and among CohBar, Inc. and the Regents of the University
of California, and Albert Einstein College of Medicine of Yeshiva University - Incorporated by reference to Exhibit 10.5 to
our Registration Statement on Form S-1 (File No. 333-200033) as filed with the Commission on November 10, 2014.
10.6*
Form of Indemnification Agreement - Incorporated by reference to Exhibit 10.6 to our Registration Statement on Form S-1
(File No. 333-200033) as filed with the Commission on November 10, 2014.
10.7*
Common Stock Purchase Warrant, dated April 11, 2014, issued to Jon Stern - Incorporated by reference to Exhibit 10.7 to our
Registration Statement on Form S-1 (File No. 333-200033) as filed with the Commission on November 10, 2014.
10.8
Form of Common Stock Purchase Warrants issued January 9, 2014 - Incorporated by reference to Exhibit 10.8 to our
Registration Statement on Form S-1 (File No. 333-200033) as filed with the Commission on November 10, 2014.
10.9
Form of Common Stock Purchase Warrants issued July 2017- Incorporated by reference to Exhibit 4.1 to our Current Report
on Form 8-K as filed with the Commission on July 18, 2017.
10.10*
10.11*
10.12*
10.13*
10.14*
10.15*
10.16*
23.1
31.1
Executive Employment Agreement, dated April 11, 2014, between CohBar, Inc. and Jon Stern - Incorporated by reference to
Exhibit 10.11 to our Registration Statement on Form S-1 (File No. 333-200033) as filed with the Commission on November
10, 2014.
Executive Employment Agreement, dated November 27, 2013, between CohBar, Inc. and Jeffrey F. Biunno - Incorporated
by reference to Exhibit 10.12 to our Registration Statement on Form S-1 (File No. 333-200033) as filed with the
Commission on November 10, 2014.
Amendment, dated as of July 11, 2016, to Executive Employment Agreement, dated as of November 27, 2013, between
CohBar, Inc. and Jeffrey F. Biunno. Incorporated by reference to Exhibit 10.1 to our Quarterly Report on Form 10-Q for the
quarter ended September 30, 2016, filed with the Commission on November 14, 2016.
Executive Employment Agreement, dated November 17, 2014, between CohBar, Inc. and Kenneth Cundy - Incorporated by
reference to Exhibit 10.13 to the Amendment No. 2 of our Registration Statement on Form S-1 (File No. 333-200033) as filed
with the Commission on November 28, 2014.
Consulting Agreement, dated November 10, 2011, by and between the Company and Nir Barzilai, as extended by an
extension agreement dated November 1, 2014 - Incorporated by reference to Exhibit 10.13 to our Registration Statement on
Form S-1 (File No. 333-200033) as filed with the Commission on November 10, 2014.
Consulting Agreement, dated September 29, 2014, by and between the Company and Pinchas Cohen - Incorporated by
reference to Exhibit 10.14 to our Registration Statement on Form S-1 (File No. 333-200033) as filed with the Commission
on November 10, 2014.
Executive Employment Agreement, dated March 7, 2016, by and between CohBar, Inc. and Simon Allen - Incorporated by
reference to Exhibit 10.13 to our Registration Statement on Form S-1 (File No. 333-200033) as filed with the Commission
on April 26, 2016.
Consent of independent registered public accounting firm.
Certification of Chief Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act of
1934, as amended.
31.2
Certification of Chief Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act of
1934, as amended.
32.1
Certification of Chief Executive Officer and 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
XBRL Instance Document
101.SCH XBRL Taxonomy Extension Schema Document
101.CAL XBRL Taxonomy Extension Calculation Linkbase Document
XBRL Taxonomy Extension Definition Linkbase Document
101.DEF
XBRL Taxonomy Extension Label Linkbase Document
101.LAB
101.PRE
XBRL Taxonomy Extension Presentation Linkbase Document
*
Indicates management contract, compensatory agreement or arrangement, in which our directors or executive officers may participate.
61
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.
SIGNATURES
Date: April 2, 2018
By:
COHBAR, INC.
/s/ Jeffrey F. Biunno
Jeffrey F. Biunno
Chief Financial Officer
(Principal Financial and
Accounting Officer)
POWER OF ATTORNEY
Each person whose individual signature appears below hereby authorizes and appoints Jeffrey F. Biunno and Simon Allen, and each of
them, with full power of substitution and resubstitution and full power to act without the other, as his true and lawful attorney-in-fact and
agent to act in his name, place and stead and to execute in the name and on behalf of each person, individually and in each capacity stated
below, and to file any and all amendments to this report, with all exhibits thereto, and other documents in connection therewith, with the
Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and
perform each and every act and thing, ratifying and confirming all that said attorneys-in-fact and agents or any of them or their or his
substitute or substitutes may lawfully do or cause to be done by virtue thereof.
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.
Signature
/s/ Simon Allen
Simon Allen
/s/ Jeffrey F. Biunno
Jeffrey F. Biunno
/s/ Jon L. Stern
Jon L. Stern
/s/ Albion J. Fitzgerald
Albion J. Fitzgerald
/s/ Nir Barzilai
Nir Barzilai
/s/ Pinchas Cohen
Pinchas Cohen
/s/ Marc E. Goldberg
Marc E. Goldberg
/s/ John Amatruda
John Amatruda
Title
Chief Executive Officer
(Principal Executive Officer)
Chief Financial Officer, Treasurer and Secretary
(Principal Financial and Accounting Officer)
Date
April 2, 2018
April 2, 2018
Chief Operating Officer and Director
April 2, 2018
Chairman of the Board of Directors
April 2, 2018
Director
Director
Director
Director
62
April 2, 2018
April 2, 2018
April 2, 2018
April 2, 2018
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM’S CONSENT
We consent to the incorporation by reference in the Registration Statement of CohBar, Inc. on Form S-8 (File No. 333-205412) and Form
S-3 (File No. 333-221724) of our report dated April 2, 2018 with respect to our audits of the financial statements of CohBar, Inc. as of
December 31, 2017 and 2016 for the years ended December 31, 2017 and 2016, which report is included in this Annual Report on Form 10-
K of CohBar, Inc. for the year ended December 31, 2017.
Exhibit 23.1
/s/ Marcum llp
Marcum llp
New York, NY
April 2, 2018
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
EXHIBIT 31.1
I, Simon Allen, certify that:
1.
I have reviewed this Annual Report on Form 10-K of CohBar, 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)) 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 general 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.
April 2, 2018
Date
By:
/s/ Simon Allen
Simon Allen
Chief Executive Officer
(Principal Executive Officer)
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
EXHIBIT 31.2
I, Jeffrey F. Biunno, certify that:
1.
I have reviewed this Annual Report on Form 10-K of CohBar, 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)) 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 general 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.
April 2, 2018
Date
By:
/s/ Jeffrey F. Biunno
Jeffrey F. Biunno
Chief Financial Officer
(Principal Financial Officer)
CERTIFICATION PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
(Subsection (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code)
EXHIBIT 32.1
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States
Code), the undersigned officers of CohBar, Inc., a Delaware corporation (the “Company”), do hereby certify that:
1. To our knowledge, the Annual Report on Form 10-K for the year ended December 31, 2017 (the “Form 10-K”) of the Company
fully complies with the requirements of Section 13(a) or 15(d) of the Securities Act of 1934; and
2. The information contained in the Form 10-K fairly presents, in all material respects, the financial condition and results of operations
of the Company.
April 2, 2018
Date
April 2, 2018
Date
By:
By:
/s/ Simon Allen
Simon Allen
Chief Executive Officer
(Principal Executive Officer)
/s/ Jeffrey F. Biunno
Jeffrey F. Biunno
Chief Financial Officer
(Principal Financial and Accounting Officer)