UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
X ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2023
☐ 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: 000-55264
Delaware
(State or other jurisdiction of incorporation or organization)
45-0486747
(I.R.S. Employer Identification No.)
DYADIC INTERNATIONAL, INC.
(Exact name of registrant as specified in its charter)
1044 North U.S. Highway One, Suite 201
Jupiter, Florida 33477
(Address of principal executive offices) (Zip Code)
(561) 743-8333
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Trading Symbol(s)
DYAI
Securities registered pursuant to Section 12(g) of the Act: None.
Title of each class
Common Stock, par value $0.001 per share
Name of each exchange on which registered
The NASDAQ Stock Market LLC
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No X
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 X
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 X No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of
this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes X No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company.
See 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 X
Accelerated filer ☐
Smaller reporting company X
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction
of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the
registrant’s executive officers during the relevant recovery period pursuant to § 240.10D-1(b). ☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial
reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. Yes ☐ No X
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No X
The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant (20,274,721 shares) computed by reference to the closing price of
$1.93 as reported on the NASDAQ Stock Market on June 30, 2023 (the last business day of the registrant’s most recently completed second fiscal quarter) was approximately $39.1
million. Shares of the registrant’s common stock held by executive officers, directors, and other affiliates have been excluded from this calculation. This determination of affiliate
status is not necessarily a conclusive determination for other purposes.
As of March 27, 2024, the registrant had 28,974,105 shares of common stock outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
The information required by Part III of this Report, to the extent not set forth herein, is incorporated in this Report by reference to the Registrant’s definitive proxy statement
relating to the 2024 annual meeting of shareholders. The definitive proxy statement will be filed with the Securities and Exchange Commission within 120 days after the end of the
2023 fiscal year.
TABLE OF CONTENTS
Business
Risk Factors
Unresolved Staff Comments
Cybersecurity
Properties
Legal Proceedings
Mine Safety Disclosures
Market for Registrant’s Common Equity, and Related Stockholder Matters and Issuer Purchases of Equity Securities
Selected Financial Data
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Quantitative and Qualitative Disclosures about Market Risk
Financial Statements and Supplementary Data
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Controls and Procedures
Other Information
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Directors, Executive Officers and Corporate Governance
Executive Compensation
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Certain Relationship and Related Transactions, and Director Independence
Principal Accountant Fees and Services
Exhibits and Financial Statement Schedules
Form 10-K Summary
PART I
Item 1.
Item 1A.
Item 1B.
Item 1C.
Item 2.
Item 3.
Item 4.
PART II
Item 5.
Item 6.
Item 7.
Item 7A.
Item 8.
Item 9.
Item 9A.
Item 9B.
Item 9C.
PART III
Item 10.
Item 11.
Item 12.
Item 13.
Item 14.
PART IV
Item 15.
Item 16.
SIGNATURES
INDEX TO FINANCIAL STATEMENTS
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F-1
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS AND RISK FACTOR SUMMARY
Information (other than historical facts) set forth in this Annual Report on Form 10-K (the "Annual Report” or the "Form 10-K”) contains forward-looking statements
within the meaning of the Federal securities laws, which involve many risks and uncertainties that could cause our actual results to differ materially from those reflected in the
forward-looking statements. Forward-looking statements generally can be identified by use of the words "expect,” "should,” "intend,” "anticipate,” "will,” "project,” "may,”
"might,” "potential,” or "continue” and other similar terms or variations of them or similar terminology. Such forward-looking statements are included under Item 7 "Management’s
Discussion and Analysis”. Dyadic International, Inc., and its subsidiaries cautions readers that any forward-looking information is not a guarantee of future performance and that
actual results could differ materially from those contained in the forward-looking information. Such statements reflect the current views of our management with respect to our
operations, results of operations and future financial performance.
Forward-looking statements involve many risks, uncertainties or other factors beyond Dyadic’s control. These factors include, but are not limited to, the items in the
following list, which also summarizes some of our more principal risks:
Risks Related to Our Business and Financial Condition
o We may not succeed in implementing our business strategy.
o We have a history of net losses, and we may not achieve or maintain profitability.
o We could fail to manage our growth.
o Our revenue growth depends in part on market and regulatory acceptance of our microbial protein production platforms and other technologies to develop
and manufacture animal and/or human biopharmaceutical products and non-pharmaceutical products.
o We may fail to commercialize our microbial protein production platforms or our other technologies for the expression of therapeutic proteins, antibodies,
o
vaccines, and metabolites or other non-pharmaceutical biologic products.
If our competitors develop technologies and products more quickly and market more effectively than our product candidates, our commercial opportunity will
be reduced or eliminated.
o Alternative technologies may not require microbial or other cell produced proteins, such as our proprietary C1 cells and Dapibus™.
o Our SARS-CoV-2 vaccine candidates are at the clinical stage and have not been approved for sale. We have not developed, manufactured or commercialized
any vaccine product in the past, and we may be unable to produce a vaccine that can be used to successfully prevent the SARS-CoV-2 virus or its variants of
concern, in a timely and economical manner, if at all.
The results of nonclinical studies and early-stage clinical trials may not be predictive of future results.
o
o We may need substantial additional capital in the future to fund our business.
o Changes in global economic and financial markets may have a negative effect on our business.
o We face risks related to widespread outbreaks of contagious disease or other biological threats, any of which could significantly disrupt our operations and
have a material adverse effect on our business, employees, directors, consultants, collaborators and other third parties, including business development
activities and research and development projects conducted by third party contract research organizations parties.
o Our sales and operations are subject to the risks of doing business internationally.
o
If we lose key personnel, including key management or board members, or are unable to attract and retain additional personnel, it could delay our technology
and product development programs and harm our R&D efforts, and we may be unable to pursue research funding, licenses and other forms of collaborations
or develop our own products.
o We may be sued for product liability.
o
o Our ability to use our net operating loss carryforwards to offset future taxable income may be subject to certain limitations.
o We may make acquisitions, investments and strategic alliances that may use significant resources, result in disruptions to our business or distractions of our
Foreign currency fluctuations could adversely affect our results.
management, may not proceed as planned, and could expose us to unforeseen liabilities.
o We rely significantly on information technology, including artificial intelligence and machine learning, and any failure, inadequacy, interruption or security
lapse of that technology, including any cybersecurity incidents, could harm our ability to operate our business effectively.
Information technology system failures, network disruptions or cyber security breaches could adversely affect our business.
o
o Changes to our outsourced software or infrastructure vendors as well as any sudden loss, breach of security, disruption or unexpected data or vendor loss
associated with our information technology systems could have a material adverse effect on our business.
Risks Related to Dependence on Third Parties
o We are dependent on collaborations with third parties, and if we fail to maintain or successfully manage existing, or enter into new, strategic collaborations,
we may not be able to develop and commercialize many of our technologies and products and achieve profitability.
o We have limited or no control over the resources that any collaborator or licensee may devote to our programs, and reductions in collaborators’ R&D
budgets may affect our businesses.
o We heavily rely on contracts with third-party contract research organizations ("CROs”) and other third-party service providers to conduct our research and
development, pre-clinical, CMC and cGMP manufacturing, fill and finish, and potential clinical trials, which may not be available to the Company on
commercially reasonable terms or at all.
o Conflicts with the CROs, other service providers, collaborators and/or licensees could harm our business.
o We rely on our collaborators and other third parties to deliver timely and accurate information in order to accurately report our financial results as required by
law.
o Changes to our outsourced software or infrastructure vendors as well as any sudden loss, breach of security, disruption or unexpected data or vendor loss
associated with our information technology systems could have a material adverse effect on our business.
Risks Related to Government Regulations and Environmental, Social, and Governance Issues
Potential future regulations limiting our ability to sell genetically engineered products could harm our business.
Public views on ethical and social issues may limit use of our technologies.
o
o
o Our results of operations may be adversely affected by environmental, health and safety laws, regulations and liabilities.
o
Increasing scrutiny and changing expectations from customers, regulators, investors, and other stakeholders with respect to our environmental, social and
governance practices may impose additional costs on us or expose us to new or additional risks.
o We have no experience submitting applications to the FDA or similar regulatory authorities in the past and could be subject to lengthy and/or unfavorable
regulatory proceedings.
Risks Relating to Intellectual Property
o
o
Failure to protect our intellectual property and the intellectual property of certain third parties could harm our competitive position.
Litigation or other proceedings or third-party claims of intellectual property infringement could require us to spend significant time and resources and could
prevent us and our collaborators from commercializing our or their technologies and products or negatively impact our stock price.
o Confidentiality agreements with employees and others may not adequately prevent disclosures of trade secrets and other proprietary information.
Risks Related to Our Common Stock
The price of our shares of common stock is likely to be volatile, and you could lose all or part of your investment.
o
o Our quarterly and annual operating results may be volatile.
o We do not expect to pay cash dividends in the future.
o Our anti-takeover defense provisions may deter potential acquirers and depress our stock price.
o Concentration of ownership among our existing officers, directors and principal stockholders may prevent other stockholders from influencing significant
corporate decisions and depress our stock price.
Future issuances of shares of our common stock may negatively affect our stock price.
The Company is exposed to credit risk and fluctuations in the values of its investment portfolio.
o
o
o We are a smaller reporting company, and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less
attractive to investors.
We caution you that the foregoing list of important factors is not exclusive. Any forward-looking statements are based on our beliefs, assumptions and expectations of
future performance, considering the information currently available to us. These statements are only predictions based upon our current expectations and projections about future
events. There are important factors that could cause our actual results, level of activity, performance or achievements to differ materially from the results, level of activity,
performance or achievements expressed or implied by the forward-looking statements. New risks emerge from time to time and it is not possible for our management to predict all
risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from
those contained in any forward-looking statements we may make. Before investing in our common stock, investors should carefully read the information set forth under the caption
"Risk Factors” and elsewhere in this Annual Report which could have a material adverse effect on our business, results of operations and financial condition.
You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking
statements are reasonable, we cannot guarantee that the future results, levels of activity, performance and events and circumstances reflected in the forward-looking statements
will be achieved or occur. Except as required by law, we undertake no obligation to publicly update any forward-looking statements for any reason after the date of this Annual
Report to conform these statements to actual results or to changes in our expectations.
We qualify all our forward-looking statements by these cautionary statements. In addition, with respect to all our forward-looking statements, we claim the protection of
the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
4
Item 1.
Business
Overview
PART I
Dyadic International, Inc. ("Dyadic”, "we”, "us”, "our”, or the "Company”) is a global biotechnology platform company based in Jupiter, Florida with operations in the
United States and a satellite office in the Netherlands, and it utilizes several third-party consultants and research organizations to carry out the Company’s activities. Over the past
two plus decades, the Company has developed a gene expression platform for producing commercial quantities of industrial enzymes and other proteins, and has previously
licensed this technology to third parties, such as Abengoa Bioenergy SA, BASF SE, Codexis, Inc. and others, for use in industrial (non-pharmaceutical) applications. This
technology is based on the Thermothelomyces heterothallica (formerly known as Myceliophthora thermophila) fungus, which the Company named C1.
On December 31, 2015, the Company sold its industrial technology business to Danisco USA ("Danisco”), the industrial biosciences business of DuPont (NYSE: DD) (the
"DuPont Transaction”). As part of the DuPont Transaction, Dyadic retained co-exclusive rights to the C1-cell protein production platform for use in all human and animal
pharmaceutical applications, and currently, the Company has the exclusive ability to enter into sub-license agreements (subject to the terms of the license and to certain
exceptions) for use in all human and animal pharmaceutical applications. Danisco retained certain rights to utilize the C1-cell protein production platform in pharmaceutical
applications, including the development and production of pharmaceutical products, for which it will be required to make royalty payments to Dyadic upon commercialization. In
certain circumstances, Dyadic may owe a royalty to either Danisco or certain licensors of Danisco, depending upon whether Dyadic elects to utilize certain patents either owned by
Danisco or licensed in by Danisco.
After the DuPont Transaction, the Company has been focused on building innovative microbial protein production platforms to address the growing demand for global
protein bioproduction utilizing its advanced microbial platforms to develop and manufacture prophylactic, therapeutic, and nutritional biopharmaceutical products for human and
animal health and wellness.
Our Technology
Our mission is to leverage our proprietary highly productive, and scalable microbial fungal protein production platforms to meet the growing demand for proteins in both
human and animal health markets worldwide. Additionally, we aim to enable the rapid development and large-scale manufacturing of cost-effective proteins, metabolites, and other
biologic products, extending beyond pharmaceutical applications in areas such as food, nutrition, and wellness.
The C1-cell protein production platform is a versatile thermophilic filamentous fungal expression system customized for the development and production of biologic
products including enzymes and other proteins for human and animal health. Potential applications to be produced from C1-cells include protein antigens, ferritin nanoparticles,
virus-like particles ("VLPs”), monoclonal antibodies ("mAbs”), Bi/Tri-specific antibodies, Fab antibody fragments, Fc-fusion proteins, as well as other therapeutic enzymes and
proteins. The Company participates in multiple funded research collaborations with certain leading animal and human pharmaceutical companies. These partnerships are
strategically engaged to leverage the potential of our C1-cell protein production platform in the development of innovative vaccines and drugs, as well as biosimilars and/or
biobetters, which we believe will contribute to advancements in medical science and healthcare.
The Company also developed the Dapibus™ thermophilic filamentous fungal-based microbial protein production platform to enable the rapid development and large-scale
manufacture of cost-effective proteins, metabolites, and other biologic products for use in non-pharmaceutical applications, including food, nutrition, and wellness.
We believe that our microbial cell line possesses distinctive characteristics compared to conventional filamentous fungal cells. Moreover, we believe that our protein
production platforms offer potential competitive advantages in the discovery, development, and manufacturing of biologic medicines and vaccines, compared to certain other
legacy biopharmaceutical expression systems, which include but are not limited to:
Purity
High retention of target secreted protein through downstream processing
No requirement for viral (i.e., CHO and Baculovirus) or endotoxin (i.e., E. coli) removal
High Productivity
Robust and versatile growth conditions High yields of secreted protein
Low viscosity due to C1’s unique morphology
Robustness
Proven at both small and large scale, ranging from laboratory microtiter plates, shaker flasks, single use and/or stainless-steel microbial fermenters Stable and correctly
folded monoclonal antibodies (mAbs), having binding, neutralizing and certain other properties similar to CHO produced mAbs
5
Speeds
Develop stable C1-cell lines for protein production in ~ 60 days
Production time savings of ~30 days over CHO-cell production (C1: 12-14 days vs. CHO 41-54 days) Manufacturing ~ 3-4 batches of C1 produced mAbs in the same
time it takes to make 1 batch using CHO-cells
Faster product release –No requirement for viral (i.e., CHO and Baculovirus) or endotoxin (i.e., E. coli) removal allowing for earlier product release
Costs
High yields and rapid manufacturing cycle times reduce costs and shrink manufacturing footprint
C1-cells can be grown using low-cost and readily available cGMP media; C1 media < 1/20 of the cost of CHO cell media
No requirement for viral or endotoxin removal, which simplifies processing compared to CHO, Baculovirus and E. coli, saving time and money
Competition
The biotechnology and biopharmaceutical industry is intensely competitive. There is continuous demand for innovation and speed, and as the vaccine and therapeutic
markets evolve, there is always the risk that a competitor may be able to develop other compounds or drugs that are able to achieve similar or better results for indications.
Potential competition includes major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies, universities, and other
research institutions. Many of these competitors have substantially greater financial, technical, and other resources, such as larger research and development staff and experienced
marketing and manufacturing organizations with established sales forces. Smaller or early-stage companies may also prove to be significant competitors, particularly through
collaborative arrangements with large, established companies.
Currently, we are not aware of other companies pursuing a business model similar to what we are developing under our microbial filamentous fungal-based protein
production platform. However, our competitors using other protein production platforms who are significantly larger and better capitalized than us, could potentially adopt
strategies similar to our and even implement them at a faster pace. These potential competitors include multinational pharmaceutical companies, established biotechnology
companies, specialty pharmaceutical companies, universities, governmental agencies, and other research institutions that are operating in the human health and animal health
fields. Moreover, smaller or early-stage companies may emerge as significant competitors, particularly through collaborative arrangements with large, established companies.
Unlike in human and animal health, several other companies have and are actively engaged in utilizing filamentous fungal microorganisms for the development and manufacture of
low-cost proteins, metabolites, and other biological products for use in non-pharmaceutical applications, such as food, nutrition, and wellness.
We believe that our microbial fungal based protein production platforms, including C1 and Dapibus™, have significant potential to become an alternative to several
traditional production technologies currently used in the biopharmaceutical industry to produce vaccines, monoclonal antibodies, and other therapeutic proteins for both the
human and animal health markets. C1 has some inherent benefits and potential competitive advantages compared to CHO cells, E. coli, Pichia, and Insect Cells (i.e., Baculovirus) as
discussed below:
• Mammalian cells: Currently the preferred production host for most complex protein therapeutics due mainly to their ability to produce proteins with human-like
glycosylation. This market is dominated by CHO cells. Disadvantages include the longer duration required for cell line development, fermentation, and increased
costs associated with process media.
Bacterial: Bacteria such as E. coli are currently the easiest, cheapest, and quickest method for recombinant protein expression and are often used in laboratory
settings as well as commercial production of certain non-glycosylated proteins. However, they produce toxic and pyrogenic cell wall components that may make them
less suitable to produce biopharmaceuticals or food components. Moreover, insoluble expression, a frequent outcome in bacterial expression, is challenging with
regard to cost of goods due to the need for refolding and its direct impact on reduced overall yields.
•
• Yeast: In contrast to bacteria, yeast, such as Pichia pastoris, do not produce potentially toxic and pyrogenic cell wall components. Further, the genetic tools for yeast
development are advanced and enable continued engineering of new strains that may become more suitable than CHO cell lines. Disadvantages include the typically
lower protein titers than C1-cells and traditional yeast cells have a greater number of higher N and O glycosylation structures.
Insect cells: Insect cells (i.e., Baculovirus) offer protein expression with post-translational modifications like mammalian cells, ease of scale-up, and simplified cell
growth readily adapted to high-density suspension culture for large-scale expression. Baculovirus expression systems are used for producing recombinant protein,
especially for vaccine antigens. Disadvantages include the comparably lower protein yields than C1 and the need for an added viral inactivation step.
•
We believe that our microbial protein production platforms hold the potential to become leading protein production platforms for developing and manufacturing proteins
across various sectors, including biopharmaceuticals, food, nutrition, wellness, drug formulation, and research diagnostics, based on our platform's capability to expedite
development processes, achieve high protein yields, scale efficiently, utilize low-cost media, and ultimately reduce production costs.
Our Industry and Potential Markets
Based on feedback received from our collaborators and our ongoing discussions with leading pharmaceutical and biotech companies, contract manufacturing
organizations (CMOs), leading academic institutions, as well as U.S. and foreign governmental agencies, we continue to believe that the biopharmaceutical market is an attractive
opportunity to apply our C1-cell protein production platform. The Company continues to evaluate potential opportunities to expand the application of our C1-cell protein
production platform, and is currently focused on the following markets:
● Recombinant vaccines and drugs for animal and human health
● New innovative biotherapeutics
● Biosimilars / Biobetters non-Glycosylated/Glycosylated protein markets
● Drug formulation, research diagnostic and reagents
● Alternative proteins for food, health and wellness
6
The use of biologic medicines, for applications such as infectious disease vaccines and therapeutics are growing significantly. However, biologic medicines are in many
cases limited and expensive for both patients and health care systems. The Company believes that lack of access and high cost is, in part, the result of the following bottlenecks in
the development and manufacture of biologic medicines:
● Extended stable cell line development timelines
● Insufficient titers and overall yields
● Expensive, often royalty stacked, production media in the case of CHO cell lines
● Long production time for stable CHO cell lines
● Previously underfunded development efforts for more efficient next-generation gene expression systems
The Company believes that the biopharmaceutical industry can benefit from an innovative protein production platform that is safe, efficient, reliable, and cost effective.
Such a platform could facilitate the rapid and high titer production of difficult to express proteins resulting in greater patient access and more affordable biopharmaceuticals. We
believe that our C1-cell protein production platform has the potential to be an alternative to CHO, Baculovirus and other traditional expression systems to produce proteins for
vaccines, therapeutics, diagnostics, alternative foods, nutrition and wellness and other biological products.
Our Research Partners and Contract Research Organizations (CROs)
Currently, the Company is conducting its C1-cell protein production platform research and other internal and external third-party programs with several contract
organizations as follows:
(1) Research and Development Agreement with VTT Technical Research Centre of Finland, Ltd ("VTT”)
Since September 2016, the Company has been working with VTT Technical Research Centre of Finland, Ltd. ("VTT”), a third-party contract research organization, to
further modify and improve the Company’s C1-cell protein production platform to ensure a safe and efficient expression system for use in speeding up the development and
lowering the cost of manufacturing pharmaceutical products and processes. VTT is one of the leading research and technology organizations in Europe, and it has conducted
research and development on fungi and other microorganisms for more than three decades. VTT is continuing their development work to further develop our C1-cell protein
production platform.
The Company has extended its research contract with VTT multiple times to continue developing Dyadic’s C1-cell protein production platform for therapeutic protein
production, including C1 host system improvement, glycoengineering, protease deletion, and management of third-party target protein projects. A significant portion of the
research and development activities at VTT are being funded by the Company’s third-party collaborators.
(2) Other CROs and cGMP Manufacturers
The Company works with several other research providers, cGMP manufacturers, and contract research organizations from time to time, which are important to achieve the
Company’s scientific and business objectives. These entities include but are not limited to CR2O, a contract research organization, to manage and support further preclinical and
clinical development of DYAI-100, and Eleszto Genetika (Budapest, Hungary).
These arrangements are typically work for hire on an as-needed basis, however, certain of these programs, if negatively impacted due to resource availability,
disagreements, or for other reasons could lead to delays or inability to realize our research and commercial objectives. The Company, supplemented by third party funding is also
further developing its Dapibus™ protein production platform for use in non-pharmaceutical applications, such as food, nutrition, and wellness.
Our Research and Development ("R&D”) Programs
(1) Internal Research Programs
C1 Production Host Improvement Programs
The Company has research and development agreements with VTT, Eleszto Genetika (Budapest, Hungary), other CROs and service and technical providers to further
improve its C1-cell protein production platform to become an even more robust, versatile, and efficient therapeutic protein production platform. Ongoing projects include, among
others: (i) improving the C1 genetic tools, (ii) further reducing the background protease(s) levels by identifying and deleting certain protease genes and/or modifying C1
fermentation processes, (iii) developing high expression C1 cell lines by precision engineering, (iv) developing C1 cell lines to express several potential vaccine and drug
candidates and (v) modifying the glycosylation pathway of C1 cells in order for C1 to express certain mAbs and other proteins with mammalian like glycosylation structures and to
eliminate or modify certain unwanted glycan structures such as N and O-glycosylation.
We continue to generate a growing amount of data that demonstrates different C1-produced proteins are properly folded and are biologically active:
● Further development of DYAI-100 (SARS-CoV-2 RBD) vaccine candidate by preparing C1 cell lines that express and produce effective antigens against different
variants of the SARS-CoV-2 RBD in order to implement the FDA recommendation to produce annual multivalent vaccines against SARS-CoV-2 that are suitable for
the annual global threat.
● Developing additional antigens that were produced by C1 (e.g., SARS-CoV-2 Full Spike Protein, hemagglutinin (HA) and Neuraminidase (NA)) which were not only
produced at high levels, but they were also importantly shown to be safe, effective, and protective in several animal trials and in the case of influenza a challenge test
carried out by Oslo University demonstrated the potential of C1 produced antigens for seasonal and pandemic influenza.
7
● Developing C1-cells to express complex proteins such as conjugating antigens to ferritin nanoparticles, scFv (MHCII) and trimerization domains to increase efficacy.
● Developing the C1-cell protein production platform for expressing mAbs at relatively high levels and high quality (e.g., data from more than one large pharma
collaborator demonstrated that the binding kinetics of mAbs produced from C1 are virtually indistinguishable from the binding kinetics of reference mAbs which were
produced in CHO cells).
● Success in glycoengineering C1 cells to express mAbs that have human-like glycan structures.
● Expressed a number of third-party monoclonal antibodies (mAbs) which were assayed by multiple third parties who reported that the neutralizing and binding activity
assays demonstrated great similarity between C1-produced mAb and CHO-produced mAbs.
● Expressed a number of other types of therapeutic proteins, such as bi-specifics, tri-specifics and Fc-fusion proteins, at relative high yields compared to other
production hosts and high quality (e.g., expressed a third party bi-specific antibody which was assayed by the third party in an in vitro cellular activity assay which
indicated that dose response curves for the C1 expressed bi-specific antibody were very similar to the CHO expressed bi-specific antibody).
● Developed the C1-cell protein production platform to express human and bovine serum albumin and other recombinant proteins with therapeutic, drug formulation,
and research diagnostic applications.
Glycosylated Therapeutic Programs and Potential Nivolumab Commercialization Program
The Company’s longer-term objective, which will require substantially more time and capital, is to apply the C1-cell protein production platform for the large therapeutic
glycoprotein market. We believe that the rapid advances being made in genomics and synthetic biology, make the C1 fungal cell line a promising candidate to further engineer
glycosylation pathways: (i) to produce therapeutic proteins having human-like glycoforms structures such as G0, G2, G0F, and G2F; (ii) to reduce or eliminate O-glycosylation; and
(iii) to create potentially improved immunogenicity in the case of vaccines.
The initial steps to develop C1 strains that produce mAbs with mammalian-like glycosylation are progressing at VTT. Based on research results we have to date, the
Company believes that our C1-cell protein production platform has the potential to become a useful platform for the development and production of therapeutic glycoproteins with
human-like or potentially even superior glycan structures. We believe that, if successful, the glycoengineering of C1 cells may help to position the C1 protein production platform
to be an important production platform for developing and manufacturing glycosylated antibodies and other glycoproteins. These initial glycoengineered C1 cells have to date
shown reduced gene expression levels when compared to the non-glycoengineered C1 cells. Several approaches are now being applied to reach our main goal – to develop cell
line(s) that resemble the 3 main goals: (i) to produce therapeutic proteins having human-like glycoform structures, (ii) to produce therapeutic proteins at high level and (iii) to
produce stable therapeutic proteins.
We continue the development of Nivolumab (Opdivo®) as a potential biosimilar/biobetter immunotherapeutic biologic drug for human metastatic cancers, including
melanoma, lung, and other cancers. The aim of this program is to express Nivolumab (mAb) with a glycoprotein structure like Nivolumab produced in CHO cells. So far, C1
produced Nivolumab has been produced with similar glycosylated structures and the development of high producing C1 cell line that expresses a lower cost biosimilar/Biobetter
Nivolumab as part of its glycoengineering program for glycoprotein Immunoglobulin G (IgG) monoclonal antibodies is ongoing. This project has proved the concept that C1-cell
protein production platform can be applied to several very high value therapeutic or preventative monoclonal antibodies.
(2) Pharmaceutical Programs
DYAI-100, a C1-SARS-CoV-2 recombinant protein RBD vaccine candidate, is the first C1-expressed protein tested in humans. The Phase 1 randomized, double-blind,
placebo-controlled trial was designed as a first-in-human trial to assess the clinical safety and antibody response of DYAI-100, produced using the C1 platform and administered as
a booster vaccine at two single dose levels in healthy volunteers. Following the regulatory clearance from the South African Health Products Regulatory Authority (SAHPRA), the
trial was initiated in 1Q 2023 with the last patient visit occurring in 3Q 2023. On November 29, 2023, the Company announced the top-line safety results, indicating that the study
had met its primary endpoint that both the low and high dose levels of the vaccine are safe and well tolerated among participants. Additionally, the vaccine has been shown to
induce immune responses at both dose levels, suggesting its potential efficacy in generating protective immunity against the target virus.
On March 25, 2024, the Company entered into a funded research collaboration with a top ten pharmaceutical company to develop a vaccine antigen and a monoclonal
antibody produced from the C1 technology.
On March 15, 2024, the Company expanded its collaboration with Phibro Animal Health/Abic Biological Laboratories Ltd to develop vaccines and treatments for
companion and livestock animal diseases.
In March 2024, a manuscript of preclinical studies on C1 produced monoclonal antibody in non-human primates and hamsters was published in the prestigious peer-
reviewed journal Nature Communications. A non-human primate challenge study completed dosing of a C1 produced COVID-19 monoclonal antibody that had previously
demonstrated broad neutralization and protection against Omicron (BA.1 and BA.2) and the other earlier variants of concern in hamsters. Preliminary results obtained from the
challenge study with the SARS-CoV-2 Delta virus on non-human primates demonstrated potential high protection. This was the first time a C1-produced monoclonal antibody was
used in a non-human primate study validating the safety and efficacy of a C1 produced antibody for infectious diseases.
At the NIIMBL conference in February 2024, the Company showcased our project data and research results generated from the NIIMBL Grant received by the Company
under the previously announced White House’s American Rescue Plan.
On February 28, 2024, the Company’s Dutch subsidiary, Dyadic Nederland BV, entered into a strategic partnership agreement and collaboration with Rabian BV
("Rabian”), a Dutch innovative SME founded by experienced entrepreneurs and vaccine scientists. Awarded by Eurostars for the AVATAR project, a part of the European
Partnership on Innovative SMEs, and co-funded by the European Union through Horizon Europe, Rabian will use the total funding leveraging its expertise in virology to develop a
rabies vaccine using Dyadic’s C1 protein production platform to tackle the challenges posed by rabies, particularly in lower- and middle-income countries. Dyadic is expected to
receive an equity stake in Rabian, fully funded research and development costs, and specified product milestones and royalties upon commercialization.
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On February 21, 2024, the Company announced it has advanced its collaboration with the Israel Institute for Biological Research (IIBR) and its commercial arm Life Science
Research Israel (LSRI), to target emerging disease solutions. This partnership aims to leverage Dyadic’s expertise in microbial platforms for flexible scale protein bioproduction and
the IIBR’s antibodies and antigens discovery capabilities to develop and manufacture innovative solutions for addressing emerging diseases and potential bio-threats. Through
this collaboration, both parties are working towards the development of effective treatments and vaccines to combat global health challenges with the intention of future
commercialization (to date, the framework is non-binding and subject to the execution of a binding agreement to be negotiated by the parties) through collaborative out-licensing
initiatives.
On February 13, 2024, the Company announced a strategic partnership with Cygnus Technologies®, part of Maravai LifeSciences® (Nasdaq: MRVI), which has
developed the C1 Host Cell Protein ELISA Kit for the quality release of products produced using Dyadic’s protein expression platforms.
On February 6, 2024, the Company announced it has signed a fully funded evaluation agreement including a commercial option with an undisclosed leading global
biopharmaceutical company to design and produce recombinant proteins using Dyadic’s C1 filamentous fungal-based microbial protein production platform.
On October 25, 2023, the Company announced that it has entered into a new research collaboration with the Vaccine and Immunotherapy Center ("VIC”) at Massachusetts
General Hospital to express vaccine antigens for influenza A and other infectious diseases, as part of VIC's $5.88 million award from the Department of Defense ("DoD”).
On September 26, 2023, the Company entered into a development and commercialization agreement with bYoRNA combining bYoRNA’s novel eukaryotic "bio” RNA
platform with Dyadic’s industrially proven C1 protein production platform to provide the pharmaceutical industry with a potentially more cost-efficient platform for manufacturing
large quantities of lower cost mRNA, enabling access to mRNA vaccines and drugs to a broader global population.
Rubic One Health, South Africa
In April 2023, the Company expanded the license agreement with South Africa’s Rubic One Health ("Rubic”) to include vaccines and therapeutic proteins beyond COVID-
19 for both human and animal health markets. This is a collaboration to develop end-to-end solutions to develop, manufacture, commercialize, and distribute affordable vaccines
and biologics for human and animal health in underserved African countries. Tech transfer of the C1-cell protein production platform has been completed. Under the license
agreement, Dyadic is expected to receive certain marketing rights and other considerations, including milestones and royalty payments, from Rubic.
Phibro/Abic Sublicense Agreement
On February 8, 2022, the Company entered into an exclusive sublicense agreement with Abic Biological Laboratories Ltd. ("Abic”), an affiliate of Phibro Animal Health
Corporation ("Phibro”), based on an existing July 1, 2020, non-exclusive sublicense and development agreement (the "Phibro/Abic Agreement”), to provide services for a targeted
disease. Since then, the Company has expanded the Phibro/Abic Agreement to include additional research projects to develop vaccines and treatments for companion and
livestock animal diseases.
(3) Non-pharmaceutical Programs
Dyadic’s newly developed Dapibus™ filamentous fungal based microbial protein production platform is reengineered to enable the rapid development and large-scale
manufacture of low-cost proteins, metabolites, and other biologic products for use in non-pharmaceutical applications, such as food, nutrition, and wellness. Given Dyadic’s
industrial heritage, the expertise to rapidly achieve commercial scale within margin sensitive markets such as food and nutrition enzymes, provides our partners with the ability to
move from demonstration to commercial production quickly and efficiently. We are actively applying our proprietary Dapibus™ platform and other technologies to address the
unmet need to reduce the production cost in the global market for non-pharmaceutical recombinant proteins.
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Cell Culture Media Products
o Recombinant Serum Albumin: In March 2024, the Company executed a term sheet with a global albumin manufacturer and distributor to develop and license Dyadic’s
recombinant serum albumin initially for diagnostic and research-grade purposes. The Company’s animal-free recombinant serum albumin projects were initiated in late 2022
using Dyadic pharmaceutical cell lines for use in potential therapeutic, product development, research, and/or diagnostic human and animal pharmaceutical applications.
Animal-free recombinant serum albumin projects were initiated for use in potential non-pharmaceutical applications such as a component of cell culture media in nutrition,
health, and food. The Company has completed the initial analysis of its recombinant albumin products and has Certificates of Analysis for recombinant human and bovine
albumin that demonstrate comparability to reference standards used in the testing.
In March 2024, the Company entered into a co-promotion agreement with Biftek Co. for the promotion of growth media supplement for cell culture.
The Company has commenced a development program to produce recombinant transferrin for use in cell culture media for the alternative protein industry, and initial
production via our microbial platform was successful.
The Company is currently providing samples of recombinant bovine serum albumin for application testing as growth media for the cultured meat industry.
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Non-animal Dairy Products
In September 2023, the Company entered into a development and exclusive license agreement to commercialize certain non-animal dairy enzymes used in the production of
food products using Dapibus™ and received an upfront payment of $0.6 million in October 2023. The Company believes it has achieved the specified target yield level
required for a milestone payment.
The Company has developed a highly productive strain and is providing samples of recombinant alpha-lactalbumin, a whey protein, to interested collaborators.
The Company has initiated a beta-lactoglobulin animal-free recombinant whey protein project in early 2024.
The Company has commenced a recombinant lactoferrin development program and expects to provide samples of the product in the third quarter of 2024.
The Company has expressed four casein proteins and is in active discussions with potential collaborators.
Bio Industrial Products
The Company has developed several enzymes that have the potential for use in multiple industries, such as nutrition, biofuels and biorefining.
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Other Events
● On March 8, 2024, the Company issued an aggregate principal amount of $6.0 million of its 8.0% Senior Secured Convertible Promissory Notes due March 8, 2027 (the
"Convertible Notes”) in a private placement in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended. The
purchasers of the Convertible Notes include immediate family members and family trusts related to Mark Emalfarb, our President and Chief Executive Officer and a member of
our Board of Directors, including The Francisco Trust, an existing holder of more than 5% of the Company’s outstanding common stock.
● For the year ended December 31, 2023, the Company received approximately $1.3 million from the sale of its equity interest in Alphazyme LLC ("Alphazyme”). Dyadic
previously received its equity as part of the consideration for the grant of a non-exclusive license to certain of Dyadic's technology. Dyadic has the right to receive
milestone and royalty payments based on potential sales of C1-expressed products by Alphazyme. Dyadic also has the potential to receive additional payments based on
future sales of Alphazyme's existing products.
● In April 2023, the Company received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for patent application 16/640,483, titled "PRODUCTION OF
FLU VACCINE IN MYCELIOPHTHORA THERMOPHILA” (the "Patent”), and is expected to provide patent protection through 2038. The Patent will cover claims for the
development and manufacture of seasonal and pandemic influenza vaccines from the Company’s C1 protein production platform.
Government Regulation and Product Approval
As a small biotechnology company that operates in the United States, we are subject to extensive regulation. Government authorities in the United States (at the federal,
state and local level) and in other countries extensively regulate, among other things, the research, development, testing, manufacturing, quality control, approval, labeling,
packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing and export and import of drug products such as those
we are developing. Product candidates that we develop must be approved by the FDA, before they may be legally marketed in the United States and by the appropriate foreign
regulatory agency before they may be legally marketed in foreign countries. Generally, our activities in other countries will be subject to regulation that is similar in nature and
scope as that imposed in the United States, although there can be important differences. For additional discussion on the effect of existing or probable governmental regulations
on our business, see "Risk Factors—Risks Related to Government Regulations and Environmental, Social, and Governance Issues.”
Employees
As of December 31, 2023, the Company had 7 full-time employees, all of whom are located in the United States.
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Intellectual Property
Patents are important to developing and protecting our competitive position. Our general policy is to seek patent protection in the United States, major European
countries, and other jurisdictions as appropriate for our compounds and methods. U.S. patents, as well as most foreign patents, are generally effective for 20 years from the date
the earliest patent application was filed. In some cases, the patent term may be extended to recapture a portion of the term lost during the U.S. FDA regulatory review or because of
U.S. Patent and Trademark Office ("USPTO”) delays in prosecuting the application. The duration of foreign patents varies similarly, in accordance with local law.
Currently, Dyadic owns or has exclusive rights to seven (7) patent families, of which five (5) entered the national phase. The other two (2) applications are at the
international (Patent Cooperation Treaty, PCT) phase. There are currently one (1) patent and five (5) pending patent applications in the United States, one patent in South Africa,
and eighteen (18) additional patent applications in a variety of jurisdictions including Europe and China.
Our success is significantly dependent on our ability to obtain and maintain patent protection for C1 and Dapibus™, both in the United States and abroad. Our patent
position and proprietary rights are subject to various risks and uncertainties. Please read the "Risk Factors” in Item 1A of this Annual Report for information about certain risks
and uncertainties that may affect our patent position and proprietary rights.
We also rely upon unpatented confidential information to remain competitive. We protect such information principally through confidentiality agreements with our
employees, consultants, outside scientific collaborators, and other advisers. In the case of our employees, these agreements also provide, in compliance with relevant law, that
inventions and other intellectual property conceived by such employees during their employment shall be our exclusive property.
Available Information
Information that we furnish to or file with the SEC, including the Company’s annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and
any amendments to, or exhibits included in, these reports are made available for download, free of charge, through the Company’s website at www.dyadic.com as soon as
reasonably practicable. The Company’s SEC filings, including exhibits filed therewith, are also available directly on the SEC’s website at www.sec.gov.
The Company may use its website as a distribution channel of material company information. Financial and other important information regarding the Company is
routinely posted on and accessible through the Company’s website. Accordingly, investors should monitor this channel, in addition to following the Company’s press releases,
SEC filings and public conference calls and webcasts. Information contained on the Company’s website is not part of this report.
Item 1A.
Risk Factors
Investing in our common stock involves a high degree of risk. You should carefully consider the following material risks, together with the other matters described in
this Annual Report and in our financial statements and the related notes thereto in evaluating our current business and future performance. We cannot assure you that any of
the events discussed in the risk factors below will or will not occur. If we are not able to successfully address any of the following risks, we could experience significant changes
in our business, operations and financial performance. In such circumstances, the trading price of our common stock could decline, and in some cases, such declines could be
significant, and you could lose part or all of your investment. In addition to the risks described below, other unforeseeable risks that we currently believe are immaterial may
arise that adversely affect our operating results. Certain statements contained in this Annual Report (including certain statements used in the discussion of our risk factors)
constitute forward-looking statements. Please refer to the section entitled "Cautionary Note Regarding Forward-Looking Statements” appearing on page [4] of this Annual
Report for important information regarding reliance on forward-looking statements.
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Risks Related to Our Business and Financial Condition
We may not succeed in implementing our business strategy.
In connection with the December 31, 2015 sale of substantially all of the assets of our industrial technology business to Danisco (the "DuPont Transaction”),
Danisco obtained certain rights to utilize the C1-cell protein production platform for development and production of pharmaceutical products, for which it will make royalty
payments to Dyadic upon commercialization. At the same time, Dyadic retained the co-exclusive rights to the C1-cell protein production platform for use in all human and animal
pharmaceutical applications, with Dyadic currently having the exclusive ability to enter into sub-license agreements in that field (subject to the terms of the license and certain
exceptions). We cannot predict whether Danisco intends to or will pursue the use of the C1-cell protein production platform to develop or manufacture pharmaceutical products or
whether or when we might receive royalties from Danisco. In certain circumstances, Dyadic may owe a royalty to either Danisco or certain licensors of Danisco, depending upon
whether Dyadic elects to utilize certain patents owned or licensed by Danisco. Consequently, our business has changed dramatically as compared to the past, as we no longer
have any product revenue related to our enzyme business. We also now apply the C1-cell protein production platform in the biopharmaceutical market, which has higher risks and
a higher barrier to entry.
As we attempt to adapt our microbial protein production platforms, including C1 and Dapibus™ and our other technologies for use in the biopharmaceutical and other
markets, our business is subject to the execution, integration, and research and development risks that early-stage companies customarily face with new technologies, products
and markets. These risks relate to, among other things, our ability to successfully further develop our protein production platforms and our other technologies, products and
processes, assemble and maintain adequate production and research and development ("R&D”) capabilities, comply with regulatory requirements, construct effective channels of
distribution and manage growth. We have encountered and will continue to encounter risks and difficulties frequently experienced by early-stage companies in expanding and
upgrading our intellectual property, regulatory, marketing, sales and R&D capabilities, improving our accounting and financial reporting and internal controls infrastructure, and
adapting to the rapidly evolving industries in which we operate. Additionally, we are subject to competition from much larger companies with more resources than we have. Also,
the market for developing and manufacturing pharmaceutical proteins produced from a filamentous fungus, such as the C1 fungus, is a market that is not yet established and is
subject to a high level of regulatory hurdles from the U.S. Food and Drug Administration (the "FDA”) and other governmental bodies, and there is a risk that such technologies
will not be adopted by the pharmaceutical industry or governmental agencies and therefore not succeed and/or not grow at the rates projected or at all.
We have not yet commercialized any products based on our platforms and technologies, and we may never be able to do so. We do not know when or if we and/or our
current and/or future collaborators and licensees will complete any of our or their product development efforts, obtain regulatory approval for any product candidates
incorporating our technologies or successfully commercialize any approved products. Even if we and/or our licensees and collaborators are successful in developing products that
are approved for marketing, we and they will still require that these products gain regulatory approval and market acceptance. The biopharmaceutical industry is a high-risk
industry in that even if we are successful at expressing certain proteins, these proteins may fail to be advanced or approved for use or sale for many reasons including their
characteristics, biological activity, biological comparability, biological similarity, stability, glycosylation structures, containments, purity, performance, safety and regulatory
reasons.
Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to predict the timing or amount of increased
expenses or when, or if, we will be able to achieve certain technology, product and/or commercial milestones, access fees and royalties, launch products and/or processes, or
achieve profitability. In addition, our expenses could increase if we are required by the FDA or other domestic and foreign regulatory authorities to perform studies or trials in
addition to those currently expected, or if there are delays in completing additional safety studies such as toxicology and pathogenicity studies, clinical trials, preclinical studies,
animal or human studies or the development of any of our or our collaborators’ product candidates.
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We have a history of net losses, and we may not achieve or maintain profitability.
As of December 31, 2023, we had an accumulated deficit of approximately $80.3 million. Our profitability has strongly relied on, and will be even more reliant going forward
on, third party industry and government research funding, licensing partnerships and other forms of collaborations. We believe that it is likely that if we do not sign license
agreements or other forms of collaborations, we will incur losses because of our planned levels of R&D and additional general and administrative expenditures that we believe are
necessary to operate our business and further develop our microbial protein production platforms and other technologies for use in the pharmaceutical and non-pharmaceutical
industries. The amount of our future net losses will depend, in part, on the rate of increase in our expenses along with other potential cost of unforeseen circumstances, our ability
to generate research funding, government grants, receipt of access fees, milestones, royalty and other payments, and whether we are able to generate revenues by entering into
license agreements or other forms of collaborations, launch new products and/or processes from future licensees or collaborators, and our ability to raise additional capital. The net
losses we anticipate incurring over the next several years will have an adverse effect on our stockholders’ equity and working capital.
The R&D efforts needed to enhance and leverage our microbial protein production platforms, including C1 and Dapibus™, for use in developing and manufacturing
human and animal biopharmaceuticals and other non-pharmaceutical products will require significant funding and increased staffing. Therefore, we expect near-term operating and
research expenses to continue, and maybe even accelerate, as we further develop our research and business plans, and our goals and objectives. Consequently, we will require
significant additional revenue to achieve profitability. We cannot provide assurance that we will be able to generate any revenues from our focus and efforts as we intend to apply
our C1-cell and Dapibus™ into the biopharmaceutical and non-pharmaceutical industries. If we fail to enter into new license agreements or other forms of collaborations or generate
revenues and profit from additional research projects and government grants, the market price of our common stock will likely decrease. Further regulatory complications,
competition from other technologies, or delays in our research programs and the adoption and use of the C1-cell and Dapibus™ protein production platforms and our other
technologies by the biopharmaceutical and non-pharmaceutical industries may force us to reduce our staffing and research and development efforts, which may further affect our
ability to generate cash flow.
We could fail to manage our growth.
We will need to take the following steps, among others, to manage our growth. If we fail to achieve one or more of these, it could have a material adverse effect on our
business, financial condition and results of operations.
● Balance our cash burn with technology and product development;
● Maintain and add additional CROs (Contract Research Organizations), other third-party service providers or other technology collaborators;
● Maintain and add additional collaborators, strategic partners technology licensees or other forms of structures;
● Recruit, hire and maintain the required employees necessary to maintain and grow our business and to advance our technologies and products;
● Achieve technical and commercial success in our research and product development programs;
● Access required manufacturing capacity;
● Access additional capital;
● Recruit and maintain consultants, board members and scientific advisory board members; and
● Manage scientific risks and uncertainties that may arise during our R&D and regulatory programs.
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Our revenue growth depends in part on market and regulatory acceptance of our microbial protein production platforms and other technologies to develop and manufacture
animal and/or human biopharmaceutical and non-pharmaceutical products.
The success of our biopharmaceutical business will depend on our ability to develop, register, and introduce similar, new and improved technologies and products in a
timely manner, at significantly lower manufacturing costs that address the evolving requirements of the pharmaceutical industry and potential customers. There is no assurance
that the C1-cell protein production platform or any product expressed from C1, or our other technologies, will perform the same or better, save our customers money relative to
existing gene expression technologies or those of our competitors, provide our customers with other benefits, obtain governmental safety and regulatory approvals, be registered
or gain market acceptance. If we fail to develop similar, new and better performing technologies, products and processes at significantly lower manufacturing costs, make
fermentation yield improvements on our existing production processes, generate the necessary safety and regulatory data or gain registration and market acceptance of the C1-cell
and DapibusTM protein production platforms, or our other technologies, products or processes, we could fail to recoup our R&D investments and fail to capitalize on potential
opportunities or gain market share from our competitors. Any failure, for technological, quality, safety, regulatory, or other reasons, to develop and launch improved technologies
and new products, could negatively impact our business, financial condition and results of operation.
The dynamic and conservative nature of the biopharmaceutical industry, the unpredictable nature of the product development process and the time and cost of new
technology adoption in the biopharmaceutical industry may affect our ability to meet the requirements of the marketplace or achieve market and/or regulatory acceptance.
The expenses or losses associated with unsuccessful technology and product development activities or lack of market acceptance of our new technologies and products
could harm our business, financial condition and results of operations.
We may fail to commercialize our microbial protein production platforms or other technologies for the expression of therapeutic proteins, antibodies, vaccines, and
metabolites or other non-pharmaceutical biologic products.
We have not yet completed the necessary safety, efficacy, cost and regulatory studies, or the commercialization of any therapeutic proteins, antibodies and vaccines, and
metabolites or other non-pharmaceutical biologic products based on C1 or Dapibus™.
To date, drug companies have developed and commercialized only a small number of gene-based products in comparison to the total number of drug molecules available
in the marketplace. Our biopharmaceutical business should be evaluated as having the same risks as those inherent to early-stage biotechnology companies because the
application of the C1-cell protein production platform for the expression of pre-clinical and clinical quantities of therapeutic proteins, antibodies and vaccines is still in early
development.
Successful development of our microbial protein production platforms, including C1 and Dapibus™, for biopharmaceutical and non-pharmaceutical purposes will require
significant research, development and capital investment, including testing, to prove its safety, efficacy and cost-effectiveness. In general, our experience has been that each step
in the process has been longer and costlier than originally projected, and we anticipate that this is likely to remain the case with respect to the continuing development efforts of
our biopharmaceutical and non-pharmaceutical business.
If our competitors develop technologies and products more quickly and market more effectively than our product candidates, our commercial opportunity will be reduced or
eliminated.
The biopharmaceutical industry is characterized by rapid technological change, and the area of gene and protein research and platform development is a rapidly evolving
field. Any biopharmaceutical products we or our current collaborators or licensees develop through the C1-cell protein production platform, or through our other technologies, will
compete in highly competitive and regulated markets. Many of the organizations competing with us in the market for such products have more capital resources, larger R&D and
marketing staff, facilities and capabilities, and greater experience in research and development, regulatory approval, manufacturing and commercialization of technology and
products. Accordingly, our competitors may be able to develop technologies and products more rapidly. Our future success will depend on our ability to maintain a competitive
position with respect to technological advances in terms of product and process quality, stability, safety, productivity and cost. If a competitor develops superior technology or
products, or more cost-effective alternatives to our and our collaborators’ or licensees’ technologies, products or processes, it could have a material adverse effect on our
business, financial condition and results of operations. Well-known and highly competitive biotechnology companies offer comparable or alternative technologies for the same
products and services as our biopharmaceutical and non-pharmaceutical business. We anticipate that we and our current or future collaborators and licensees will continue to
encounter increased competition as new companies enter these markets and as the development of biological processes and products evolves.
Alternative technologies may not require microbial or other cell produced proteins, such as our proprietary C1 cells.
Research is being conducted with cell or gene-based therapies and other technologies that offer a possible alternative to producing proteins as they are being produced
today based on microbial, organic matter containing Carbon, Hydrogen, and Oxygen or other organisms, such as our proprietary C1 cells or Dapibus™. Alternative methods may
allow genes to be directly inserted into cells that can be implanted into animals and humans directly, displacing the need for the existing methods used for the development of
biologic vaccines and drugs. If they are successful, these new methods may supplant or greatly reduce the need for microorganisms, Carbon, Hydrogen, and Oxygen or other
organisms, including our C1 cells and Dapibus™, to produce these proteins externally as the injected cells in animals and humans may be able to do so internally.
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Our SARS-CoV-2 vaccine candidates are at the clinical stage and have not been approved for sale. We have not developed, manufactured or commercialized
any vaccine product in the past, and we may be unable to produce a vaccine that can be used to successfully prevent the SARS-CoV-2 virus or its variants of concern, in a
timely and economical manner, if at all.
Our DYAI-100, SARS-CoV-2 vaccine candidate has successfully completed its Phase 1 clinical trial in South Africa. However, we do not plan to continue Phase 2/3 clinical
trials of DYAI-100 unless we obtain funding from our partners and collaborators. Moreover, adverse events, or the perception of adverse events, relating to vaccine product
candidates and delivery technologies may negatively impact our ability to develop commercially successful products and also may lead to greater government regulation, which
could have a material effect on our ability to develop and market our SARS-CoV-2 vaccine product candidates.
The success of our efforts to develop and commercialize our vaccine product candidates could fail for a number of reasons. Accordingly, we may be unable to produce
a vaccine that successfully targets SARS-CoV-2 in a timely and economical manner, if at all. For example, we expect to commit significant financial resources and personnel to the
development of SARS-CoV-2 vaccine product candidates, which may cause delays in or otherwise negatively impact our other product candidate development program. The
outcome of any research and development program is highly uncertain. Only a small fraction of biotechnology and vaccine development programs ultimately result in commercial
products or even product candidates, and a number of events could delay our development efforts and negatively impact our ability to obtain regulatory approval for, and to
manufacture, market and sell, a vaccine. Additionally, our ability to develop an effective vaccine will depend on our ability to work on an accelerated timeline, with limited access to
financial resources beyond those that we currently possess, and in competition with a significant number of better-funded and more experienced vaccine-development companies.
Moreover, uncertainties exist surrounding the longevity and severity of COVID-19 as a global health concern, and given the COVID-19 pandemic is now relatively contained
and the risk of further spread is diminished, we may be unable to identify strategic partners willing to work with and support us in our development efforts and/or the market that
we anticipate for this product candidate may not exist or may be much smaller than we previously anticipated. Alternatively, even if a market exists, our vaccine product candidates
could be found to be ineffective or unsafe, or otherwise fail to receive necessary regulatory clearances. Our vaccine product candidates, even if safe and effective, could be
difficult to manufacture on a large scale or uneconomical to market, or our competitors could develop superior products more quickly and efficiently or more effectively market their
competing products. Accordingly, our inability to develop a commercially successful vaccine product could materially harm our business.
The results of nonclinical studies and early-stage clinical trials may not be predictive of future results.
The results of nonclinical studies may not be predictive of the results of clinical trials, and the results of any early-stage clinical trials we commence may not be predictive
of the results of the later-stage clinical trials. Vaccine and drug candidates in later stages of clinical trials may fail to show the desired safety and efficacy despite having progressed
through nonclinical studies and initial clinical trials. There is a high failure rate for drugs proceeding through clinical trials, and a number of companies in the pharmaceutical and
biotechnology industries have suffered significant setbacks in clinical development even after achieving promising results in earlier studies. There can be no assurance that any of
our current or future clinical trials will ultimately be successful or support further clinical development of any of our vaccine and drug candidates. Even if our clinical trials are
completed, the results may not be sufficient to obtain regulatory approval of any products. Any such setbacks in our clinical development could have a material adverse effect on
our business and operating results.
We may need substantial additional capital in the future to fund our business.
Our future capital requirements may be substantial, particularly as we continue to further develop, engineer and optimize our microbial protein production platforms and
other proprietary technologies, products and processes for licensing for research and development, and commercialization of potential animal and human pharmaceutical products.
We currently have very little leverage, and if our capital resources are insufficient to meet our capital requirements, we will have to raise additional funds to continue the
development of our technologies and complete the development and commercialization of products, if any, resulting from our technologies. If the acquisition of additional funds is
not possible or if we engage in future equity financings, dilution to our existing stockholders may result. If we raise capital through debt financing, we may be subject to restrictive
covenants that limit our ability to conduct our business. We may not be able to raise funds on terms that are favorable to us, if at all. If we fail to raise sufficient funds and incur
losses, our ability to fund our operations, take advantage of strategic opportunities, develop products or technologies, or otherwise respond to competitive pressures could be
significantly limited. If this happens, we may be forced to delay or terminate research or development programs or the commercialization of products resulting from our
technologies, curtail or cease operations or obtain funds through collaborative and licensing arrangements that may require us to relinquish commercial rights, sell certain assets of
the company which will limit future opportunities, or grant licenses on terms that are not favorable to us. Without sufficient funding or revenue, we may have to curtail, cease, or
dispose of one or more of our operations, which would have a material adverse effect on our business, financial condition, and future prospects.
Changes in global economic and financial markets may have a negative effect on our business.
Our business is subject to a variety of market forces including, but not limited to, domestic and international economic, political and social conditions. Many of these
forces are beyond our control. Any change in market conditions that negatively impacts our operations or the demand of our current or prospective customers could adversely
affect our business operations. For example, economic uncertainty and volatility, including as a result of high-interest rates and inflation, have had and may continue to have a
material adverse effect on our business.
Changes in the global financial, pharmaceutical and biotech markets may make it difficult to accurately forecast operating results. These changes have had, and may
continue to have, a negative effect on our business, results of operations, financial condition and liquidity. In the event of a downturn in global economic activity, current or
potential business partners may go out of business, may be unable to fund purchases or determine to reduce purchases, all of which could lead to reduced demand for our
products and increased payment delays or defaults. We are also limited in our ability to reduce costs to offset the results of a prolonged or severe economic downturn given
certain fixed costs associated with our operations and difficulties if we over strained our resources. The timing and nature of a sustained recovery in the credit and financial
markets remain uncertain, and there can be no assurance that market conditions will significantly improve in the near future or that our results will not continue to be materially and
adversely affected.
In addition, geopolitical risks, including those arising from political turmoil, trade tension or the imposition of trade tariffs and/or sanctions, terrorist activity and acts of
civil or international hostility, are increasing. For instance, the ongoing military conflict between Russia and Ukraine, as well as conflicts in the Middle East have had negative
impacts on the global economy and is expected to have further global economic consequences. Any such events and responses, including regulatory developments, may cause
significant volatility and declines in the global markets, disproportionate impacts to certain industries or sectors, disruptions to commerce (including to economic activity, travel
and supply chains), loss of life and property damage, and may materially and adversely affect the global economy or capital markets, as well as our business and results of
operations. Should an economic slowdown occur in the U.S. or globally, our business and results of operations may be materially adversely affected.
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We face risks related to widespread outbreaks of contagious disease or other biological threats, any of which could significantly disrupt our operations and have a material
adverse effect on our business, employees, directors, consultants, collaborators and other third parties, including business development activities and research and
development projects conducted by third party contract research organizations parties.
Significant outbreaks of contagious diseases, and other adverse public health developments, have had and could have a material impact on our business operations,
financial condition, and operating results. Pandemics and other outbreaks of contagious disease have in the past and could in the future significantly impact the operation of our
business. For example, pandemics have in the past adversely affected our ability to carry on certain business development activities, including as a result of restrictions in
business-related travel, delays or disruptions in our on-going research projects, and unavailability of the employees of the Company or third-party contract research organizations
with whom we conduct business, due to illness or quarantines. In addition, pandemics and other outbreaks of contagious disease have in the past and may in the future exacerbate
other risks disclosed in this Annual Report. See, for example, "—Changes in global economic and financial markets may have a negative effect on our business.” Whether and to
what extent future pandemics and other outbreaks of contagious diseases may impact our financial and operational performance will depend on developments that include the
duration, spread and severity of the outbreak, the timetable for administering and efficacy of vaccines, the duration and geographic scope of related travel advisories and
restrictions and the extent of the impact of the pandemic or outbreak on overall demand for our products, technologies and services, and other factors beyond our control, all of
which are highly uncertain and cannot be predicted.
Our sales and operations are subject to the risks of doing business internationally.
Our sales and operations are subject to the risks of doing business internationally, as we have customers and partners located outside of the United States. Conducting business
internationally exposes us to a variety of risks, including:
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changes in or interpretations of foreign regulations that may adversely affect our ability to sell our products, repatriate profits to the United States or operate our
foreign-located facilities;
the imposition of tariffs;
the imposition of limitations on, or increase of, withholding and other taxes on remittances and other payments by foreign subsidiaries or joint ventures;
uncertainties relating to foreign laws, regulations and legal proceedings including tax, import/export, anti-corruption and exchange control laws;
the availability of government subsidies or other incentives that benefit competitors in their local markets that are not available to us;
increased demands on our limited resources created by our operations may constrain the capabilities of our administrative and operational resources and restrict our
ability to attract, train, manage and retain qualified management, technicians, scientists and other personnel;
economic or political instability in foreign countries;
difficulties associated with staffing and managing foreign operations; and
the need to comply with a variety of United States and foreign laws applicable to the conduct of international business, including import and export control laws and
anti-corruption laws.
If we lose key personnel, including key management or board members, or are unable to attract and retain additional personnel, it could delay our technology and product
development programs and harm our R&D efforts, and we may be unable to pursue research funding, licenses and other forms of collaborations or develop our own products.
Our planned activities will require retention, and ongoing recruiting of additional expertise in specific areas applicable to our industries, technologies and products being
developed. These activities will not only require the development of additional expertise by existing management personnel, but also the addition of new research and scientific,
regulatory, licensing, sales, marketing, management, accounting and finance and other personnel. The inability to acquire or develop this expertise or the loss of principal members
of our management, board of directors, consultants, accounting and finance, sales, and scientific staff could impair the growth, if any, of our business. Competition for experienced
personnel from numerous companies, academic institutions and other research facilities may limit our ability to attract and retain qualified management, directors, consultants, and
scientific personnel on acceptable terms. Failure to attract and retain qualified personnel would inhibit our ability to maintain and pursue collaborations and develop our products
and core technologies.
Personnel changes may disrupt our operations. Hiring and training new personnel will entail costs and may divert our resources and attention from revenue-generating
efforts. In addition, we periodically engage consultants to assist us in our business and operations. These consultants operate as independent contractors, and we therefore do
not have as much control over their activities as we do over the activities of our employees. Our directors and consultants may be affiliated with or employed by other parties, and
some may have consulting or other advisory arrangements with other entities that may conflict or compete with their obligations to us.
We may be sued for product liability.
We or our current and future collaborators and licenses may be held liable if any product we or they develop, or any product which is made with the use or incorporation
of, any of our technologies, causes injury or is found otherwise unsuitable or unsafe during product testing, manufacturing, marketing or sale. These claims could be brought by
various parties, including other companies who purchase products from our current and future collaborators and licenses or by end users of the products.
While we maintain product liability insurance, it may not fully cover all of our potential liabilities and our liability could in some cases exceed our total assets, which would
have a material adverse effect on our business, results of operations, financial condition and cash flows, or cause us to go out of business. Further, insurance coverage is
expensive and may be difficult to obtain and may not be available to us or to our collaborators and licensees in the future on acceptable terms, or at all. Inability to obtain sufficient
insurance coverage at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of products developed by us, or our
collaborators and licensees.
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Foreign currency fluctuations could adversely affect our results.
In the conduct of our business, in certain instances, we are required to receive payments or pay our obligations in currencies other than U.S. dollars. Especially since a
large portion of our research and development is done in Europe, our CROs and certain consultants request payments in Euros. As a result, we are exposed to changes in currency
exchange rates with respect to our business transactions denominated in non-US dollars. Fluctuations in currency exchange rates have in the past and may in the future negatively
affect our revenue, expenses and our financial position and results of operations as expressed in U.S. dollars.
Our ability to use our net operating loss carryforwards ( " NOLs ” ) to offset future taxable income may be subject to certain limitations.
In general, under Section 382 of the Internal Revenue Code, a corporation that undergoes an "ownership change” is subject to limitations on its ability to utilize its NOLs,
to offset future taxable income. If the Internal Revenue Service challenges our analysis that our existing NOLs are not subject to limitations arising from previous ownership
changes, our ability to utilize NOLs could be limited by Section 382 of the Internal Revenue Code. Future changes in our stock ownership, some of which are outside of our control,
could result in an ownership change under Section 382 of the Internal Revenue Code. Furthermore, our ability to utilize NOLs of companies that we may acquire in the future may
be subject to limitations.
We may make acquisitions, investments and strategic alliances that may use significant resources, result in disruptions to our business or distractions of our management,
may not proceed as planned, and could expose us to unforeseen liabilities.
We may seek to expand our business through the acquisition of, investment in and strategic alliances with companies, technologies, products, and services. If we are able
to identify suitable acquisition, investment or strategic alliance targets, we may be unable to successfully negotiate their acquisition at a price or on terms and conditions
acceptable to us.
We cannot assure you that, following an acquisition, investment or strategic alliance, we will achieve expected research and development results, anticipated synergies,
revenues, specific net income or loss levels that justify such transaction or that the transaction will result in increased earnings, or reduced losses, for the combined company in
any future period. Moreover, we may need to raise additional funds through public or private debt or equity financing to acquire any businesses or to provide funding for such
business, which would result in dilution for stockholders or the incurrence of indebtedness and may not be available on terms which would otherwise be acceptable to us. We may
not be able to oversee such investments nor operate acquired businesses profitably or otherwise implement our growth strategy successfully.
We rely significantly on information technology and any failure, inadequacy, interruption or security lapse of that technology, including any cybersecurity incidents, could
harm our ability to operate our business effectively.
Despite the implementation of security measures, our internal computer systems and those of third parties with which we contract are vulnerable to damage from cyber-
attacks, computer viruses, unauthorized access, natural disasters, terrorism, war, and telecommunication and electrical failures. System failures, accidents, or security breaches
could cause interruptions in our operations and could result in a material disruption of our research activities and business operations, in addition to possibly requiring substantial
expenditures of resources to remedy. While we have experienced and continue to experience system failures, accidents and security breaches from time to time, none has been
material to date. To the extent that any disruption or security breach was to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or
proprietary information, we could incur liability and delays in our research efforts and financial reporting compliance, as well as a significant increase in costs to recover or
reproduce the data.
Of special note is our risk when implementing new capabilities. The implementation of new systems and information technology could adversely impact our operations by
requiring substantial capital expenditures, diverting management’s attention, or causing delays or difficulties in transitioning to new systems. As we implement new systems, many
times both new and old systems run in parallel until all processes have successfully transferred to the new system and thorough testing has been performed. These events could
impact our customers, suppliers, subcontractors, employees, our financial reporting and our reputation and lead to financial losses from remediation actions, loss of business or
potential liability, or an increase in expense, all of which may have a material adverse effect on our business. Our systems implementations may also not result in productivity
improvements at the levels anticipated. In addition, the rapid evolution and increased adoption of artificial intelligence technologies may intensify our cybersecurity risks. Likewise,
cyber incidents, including malicious cyber-attacks perpetrated on our employees and cyber incidents caused by third parties surreptitiously accessing our systems by other
means, are an on-going risk to the security of the systems, networks, information and data of ours, our customers, subcontractors and suppliers. While we have security, internal
control and technology measures in place to protect our systems and networks, confidential business information, personal data of ours, our customers, employees, suppliers and
subcontractors, our information technology systems and those of our third-party service providers have been and may in the future be subject to system breaches. System
breaches can lead to disclosure, modification and destruction of proprietary business data, personally identifiable information, other sensitive information, production downtime or
loss of business, and damage to our reputation, competitiveness and operations. In addition, flexible working arrangements and remote working for overseas consultants may
adversely impact our ability to maintain the security, proper function and availability of our information technology and systems since remote working by our employees and
consultants could strain our technology resources and introduce operational risk, including heightened cybersecurity risk. Remote working environments may be less secure and
more susceptible to hacking attacks, including phishing and social engineering attempts that have sought, and may seek, to exploit remote working environments. In addition,
current and future laws and regulations governing data privacy and the unauthorized disclosure of confidential information, including, but not limited to rules implemented by the
SEC in 2023, may pose complex compliance challenges and result in additional costs. A failure to comply with such laws and regulations could result in penalties or fines, legal
liabilities or reputational harm. The continuing and evolving threat of cyber-attacks has also resulted in increased regulatory focus on risk management and prevention. New cyber-
related regulations or other requirements could require significant additional resources and cause us to incur significant costs, which could have an adverse effect on our results of
operations and cash flows.
Changes to our outsourced software or infrastructure vendors as well as any sudden loss, breach of security, disruption or unexpected data or vendor loss associated with our
information technology systems could have a material adverse effect on our business.
We rely on third-party software and infrastructure to run critical accounting, project management and financial information systems. If software or infrastructure vendors
decide to discontinue further development, integration or long-term maintenance support for our information systems, or there is any system interruption, delay, breach of security,
loss of data or loss of a vendor, we may need to migrate some or all of our accounting, project management and financial information to other systems. These disruptions could
increase our operational expense as well as impact the management of our business operations, which could have a material adverse effect on our financial position, results of
operations, cash flows and liquidity.
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Risks Related to Dependence on Third Parties
We are dependent on collaborations with third parties, and if we fail to maintain or successfully manage existing, or enter into new, strategic collaborations, we may not be
able to develop and commercialize many of our technologies and products and achieve profitability.
Our R&D revenue is generated from a small number of research collaborations. These collaborations could be delayed or be discontinued, as they have in the past, at any
time with little advance notice. If these research collaborations are lost or do not perform as expected, it could have a material adverse effect on our business, financial condition
and operating results.
Our ability to enter into, maintain and manage collaborations in our target markets is fundamental to the success of our business. We currently rely on, and expect to
continue to rely on, our current and future partners, in part, for research and development, manufacturing and distribution, sales and marketing services, and application and
regulatory know how. In addition, we intend to enter into additional collaborations to conduct research, develop, produce, market, license and sell our technologies and products
and processes we anticipate developing. However, we may not be successful in entering into collaborative arrangements with third parties. Any failure to enter into such
arrangements on favorable terms could delay or hinder our ability to develop and commercialize our technologies, products and processes and could increase our costs of research
and development and commercialization.
We have limited or no control over the resources that any collaborator or licensee may devote to our programs, and reductions in collaborators’ R&D budgets may affect our
businesses.
Any of our current or future collaborators or licensees may breach or terminate their agreements with us or otherwise fail to perform and conduct their required activities
successfully and in a timely manner. Our collaborators or licensees may elect not to develop products arising out of our collaborative or license arrangements or may choose not to
devote sufficient resources to the development, manufacture, market or sale of these products. If any of these events occur, we or our collaborators or licensees may not develop
our technologies or commercialize our or their products.
Fluctuations in the R&D budgets of government agencies, our customers, licensees, collaborators and research partners could have a significant impact on the interest in
and demand for our technology. Our businesses could be seriously damaged by significant decreases in life sciences and/or pharmaceutical R&D expenditures by government
agencies and existing and potential partners.
We heavily rely on contracts with third-party contract research organizations ("CROs”) and other third-party service providers to conduct our research and development, pre-
clinical, CMC and cGMP manufacturing, fill and finish, and potential clinical trials, which may not be available to the Company on commercially reasonable terms or at all.
As a result of the DuPont Transaction, we no longer own a research and development laboratory and we became dependent upon the performance and research capacity
of a number of third-party contract research organizations and other service providers to conduct our research and development projects, pre-clinical, CMC and cGMP
manufacturing, fill and finish, and potential clinical trials, which include services and programs in connection with the modification and enhancement of the Company’s C1-cell
protein production platform and to support our business development efforts for C1’s use in biopharmaceutical applications. The licensing and service arrangements with these
third parties are not guaranteed to be obtained, renewed or continued on reasonable terms, if at all. The Company may be unable to obtain, maintain or expand its access to third
party CROs and other service providers to conduct these services. Failure to obtain, maintain and expand access to certain third party CROs and other service providers could
have a material adverse impact on the Company’s research projects, financial condition and operating results. In addition, from time to time there are disagreements with such third
parties that if not resolved can have a material adverse effect on our business, financial condition and operating results.
We are heavily dependent upon the availability and performance of third-party research organizations. If we require research capacity and/or capabilities and are unable to
obtain it in sufficient quantity, and quality or at terms and conditions that are acceptable to the Company or our third party collaborators, we may not be able to offer our
technologies or products for license, or sale, or we may be required to make substantial capital investments to build out that capacity or to contract with other research
organizations on terms that may be less favorable than our current arrangements. In addition, if we contract with other research organizations, we may experience delays of several
months in qualifying them or in starting up research programs at these facilities, which could harm our relationships with our licensees, collaborators or customers, and we may be
required to make a capital investment in connection with these arrangements. This could have a material adverse effect on our business, revenues or operating results.
Additionally, if we were to be unsuccessful in retaining a CRO with the requisite experience and skills we require and were required to build our own research facility, it
could take a year or longer before such owned research facility were able to be brought online to carry out the necessary technology and product development efforts of the
Company.
Conflicts with the CROs, other service providers, collaborators and/or licensees could harm our business.
An important part of our strategy includes involvement in proprietary research programs. We may pursue opportunities in the pharmaceutical field that could conflict with
those of our collaborators and licensees. Moreover, disagreements with Danisco, our current and/or future CROs, other service providers, collaborators or licensees could develop
over rights to our intellectual property, over further licensing of our technologies to other parties in certain pharmaceutical fields, or for other reasons. Any conflict with Danisco,
our current and/or future CROs, other service providers, collaborators or licensees could reduce our ability to obtain future collaboration agreements and negatively impact our
relationship with existing collaborators or licensees, which could reduce our revenues and profits.
Some of our current and/or future CROs, other service providers, collaborators and/or licensees could also become competitors in the future. Our current and/or future
CROs, other service providers, collaborators and/or licensees could develop competing technologies or products, preclude us from entering into collaborations or license
agreements with their customers, fail to obtain timely regulatory approvals, terminate their agreements with us prematurely or fail to devote sufficient resources to the development
and commercialization of their technology and products and processes. Any of these developments could harm our technology development and value, product development
efforts, revenue, profits and overall business.
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We rely on our collaborators and other third parties to deliver timely and accurate information in order to accurately report our financial results as required by law.
We need to receive timely, accurate and complete information from a number of third parties in order to accurately and timely report our financial results. We rely on third
parties to provide us with complete and accurate information regarding research developments and data, revenues, expenses and payments owed to or by us on a timely basis. We
rely on the proper controls and procedures related to obtaining and reporting information from our CROs, licensees and collaborators related to research results and other data,
when milestones are earned, if any, when royalties are earned, if any, as well as other types of potential revenues and expenses. If the information that we receive is not accurate,
our consolidated financial statements may be materially incorrect and may require restatement. As a result, we may have difficulty in completing accurate and timely financial
disclosures, which could have a material adverse effect on our business, financial condition and results of operations and the market price of our common stock.
Risks Related to Government Regulations and Environmental, Social, and Governance Issues
Potential future regulations limiting our ability to sell genetically engineered products could harm our business.
We, our current and future collaborators and licensees expect to develop biologic products using genetically engineered microorganisms ("GMOs”). Products derived
from GMOs may in some instances be subject to bans or additional regulation by federal, state, local and foreign government agencies. These agencies may not allow us or our
collaborators and licensees to produce and market products derived from GMOs in a timely manner or under technically or commercially feasible conditions.
Compliance with FDA, Environmental Protection Agency ("EPA”) and EU regulations could result in expenses, delays or other impediments to our product development
programs or the commercialization of resulting products. The FDA currently applies the same regulatory standards to products made through genetic engineering as those applied
to products developed through traditional methodologies. Regardless of GMO status, a product may be subject to lengthy FDA reviews and unfavorable FDA determinations due
to safety concerns or changes in the FDA’s regulatory policy. The EPA regulates biologically derived enzyme-related chemical substances not within the FDA’s jurisdiction. An
unfavorable EPA ruling could delay commercialization or require modification of the production process or product in question, resulting in higher manufacturing costs, thereby
making the product uneconomical. The EU and other countries also have regulations regarding the development, production and marketing of products from GMOs, which may be
as or more restrictive than U.S. regulations.
Further, we, Danisco, and our current and future collaborators and licensees are subject to regulations in the other countries in which we operate outside of the U.S. and
EU, which may have different rules and regulations depending on the jurisdiction. Different countries have different rules regarding which products qualify as GMOs. If any of
these countries expand the definition of GMO and increase the regulatory burden on GMO products, our business could be harmed.
Other changes in regulatory requirements, laws and policies, or evolving interpretations of existing regulatory requirements, laws and policies, may result in increased
compliance costs, delays, capital expenditures and other financial obligations that could adversely affect our business or financial results.
Public views on ethical and social issues may limit use of our technologies.
Our success will depend in part upon our ability, and our current and future collaborators’ or licensees’ ability, to develop pharmaceutical and non-pharmaceutical
products discovered, developed and manufactured through the C1-cell protein production platform, and our other technologies. Governmental authorities could, for social, ethical
or other purposes, limit the use of genetic processes or prohibit the practice of using a modified C1 organism to produce biologic vaccines, drugs and other biologic products.
Concerns about the C1-cell protein production platform and our other technologies, and particularly about the expression of genes from C1 for pharmaceutical purposes, could
adversely affect their market acceptance.
The commercial success of our current and future collaborations and our licensees’ potential products will depend in part on public acceptance of the use of genetically
engineered products including enzymes, vaccines, drugs and other protein products produced in this manner. Claims that genetically engineered products are unsafe for
consumption or pose a danger to the environment, animals or humans may influence public attitudes. Our and our licensees’ genetically engineered products may not gain public
acceptance. Negative public reaction to GMOs and products could result in increased government regulation of genetic research and resulting products, including stricter labeling
laws or other regulations, and could cause a decrease in the demand for our products. If we and/or our collaborators are not able to overcome the ethical, legal, and social concerns
relating to genetic engineering, some or all of our products and processes may not gain public acceptance, which could have a material adverse effect on our business, financial
condition and results of operations.
Our results of operations may be adversely affected by environmental, health and safety laws, regulations and liabilities.
We and the CROs, collaborators and licensees are subject to various federal, state and local environmental laws and regulations relating to the discharge of materials into
the air, water and ground, the generation, storage, handling, use, transportation and disposal of hazardous materials, and the health and safety of our employees. These laws,
regulations and permits can often require expensive pollution control equipment or operational changes to limit actual or potential impacts to the environment. A violation of these
laws and regulations or permit conditions could result in substantial fines, criminal sanctions, permit revocations and/or facility shutdowns.
In addition, new laws, new interpretations of existing laws, increased government enforcement of environmental laws, or other developments could require us or our CROs
or other service providers to make additional significant expenditures. Present and future environmental laws and regulations and interpretations thereof, more vigorous
enforcement of policies and discovery of currently unknown conditions may require substantial expenditures that could have a material adverse effect on our results of operations
and financial position. Additionally, any such developments may have a negative impact on our contract manufacturers, which could harm our business.
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Increasing scrutiny and changing expectations from customers, regulators, investors, and other stakeholders with respect to our environmental, social and governance
practices may impose additional costs on us or expose us to new or additional risks.
Companies are facing increasing scrutiny from customers, regulators, investors, and other stakeholders related to their environmental, social and governance practices.
Investor advocacy groups, investment funds and influential investors are also increasingly focused on these practices, especially as they relate to the environment, health and
safety, supply chain management, diversity and human rights. Failure to adapt to or comply with regulatory requirements or investor or stakeholder expectations and standards
could negatively impact our reputation and the price of our common stock.
In addition, our customers may adopt policies that include social and environmental requirements or may seek to include such provisions in their contract terms and
conditions. These social and environmental responsibility provisions and initiatives are subject to change and vary from jurisdiction to jurisdiction, and certain elements may be
difficult and/or cost prohibitive for us to comply with given the inherent complexity and the global scope of our operations. In certain circumstances, in order to meet the
requirements or standards of our customers, we may be obligated to modify our sourcing practices or make other operational choices which may require additional investments and
increase our costs or result in inefficiencies.
Any of the factors mentioned above, or the perception that we or those with whom we conduct business have not responded appropriately to the growing concern for
such issues, regardless of whether we are legally required to do so, may damage our reputation and have a material adverse effect on our business, financial condition, results of
operations cash flows and/or the price of our common stock.
We have no experience submitting applications to the FDA or similar regulatory authorities in the past and could be subject to lengthy and/or unfavorable regulatory
proceedings.
While we understand that many of our current and future collaborators or licensees may have a proven track record of experience submitting application to the FDA or
other applicable regulatory authorities, we have no such experience in the past. Neither we nor any collaborator or licensee has yet submitted any application with the FDA or any
other regulatory authority for any product candidate generated through the use of the C1-cell protein production platform as it relates to the development and manufacture of
pharmaceutical products. The FDA may not have substantial experience with technology similar to ours, which could result in delays or regulatory action against us. We and our
current and future collaborators and licensees may not be able to able to obtain regulatory approval for C1 expressed products, which would harm our business.
The C1-cell protein production platform has been tested for use in the manufacturing of an enzyme in the production of wine, beer and fruit juices, and has generated
promising safety and toxicity data for that enzyme. The C1-cell protein production platform could produce vaccines, antibodies, or therapeutic products and enzymes that have
safety, toxicity, pathogenicity, immunogenicity and other issues associated with them. The C1-cell protein production platform and our other technologies may be subject to
lengthy regulatory reviews and unfavorable regulatory determinations if they raise safety questions which cannot be satisfactorily answered or if results from studies do not meet
regulatory requirements. An unfavorable regulatory ruling could be difficult to resolve and could delay or possibly prevent a product from being commercialized, or even delay or
prevent the use of the C1-cell protein production platform or our other technologies to produce future products, which would have a material adverse effect on our growth and
prospects. Additionally, future products produced by us or our current and future collaborators or licensees using the C1-cell protein production platform, or our other
technologies may not be approved by the FDA or other regulatory agencies in the U.S. or worldwide. There is no assurance that safety, toxicity, pathogenicity, immunogenicity
and other issues will not arise in current or future product development and manufacturing programs due to media, fermentation, inherent properties or genetic changes in the C1
and other strains and fermentation processes.
If these therapeutic protein products, antibodies or vaccines or other non-pharmaceutical products are not approved by regulators, we or our current and future
customers or collaborators and licensees will not be able to commercialize them, and we may not receive research funding, upfront license fees, milestone and royalty payments,
which are based upon the successful advancement of these products through the drug development and approval process. Even after investing significant time and expense, any
regulatory approval may also impose limitations on the uses for which we can market a product, and any marketed product and its manufacturer are subject to continual review.
Discovery of previously unknown problems with a product or manufacturer may result in new restrictions on the product, manufacturer and manufacturing facility, including
withdrawal of the product from the market. In certain countries, regulatory agencies also set or approve prices, which may result in low or unprofitable margins and would have a
material adverse effect on our business, financial condition and results of operations.
Risks Relating to Intellectual Property
Failure to protect our intellectual property and the intellectual property of certain third parties could harm our competitive position.
Our success will depend in part on our ability to obtain patents and on our and Danisco’s (as part of the DuPont Transaction, patents were assigned to Danisco) and our
current and future collaborators’ and licensees’ ability to maintain adequate protection of our and their intellectual property. If we, Danisco, or our current and future collaborators
and licensees do not adequately protect our intellectual property, competitors may be able to practice our technologies and erode our competitive advantage. The laws of some
foreign countries do not protect proprietary rights to the same extent as the laws of the United States, and many companies have encountered significant problems in protecting
their proprietary rights in these foreign countries.
However, the patent positions of biotechnology companies, including our patent position, are generally uncertain and involve complex legal and factual questions. We
will be able to protect our proprietary rights from unauthorized use by third parties only to the extent that our, and in certain instances the C1 patents assigned to Danisco, and our
current and future collaborators’ and licensees’ proprietary technologies, are covered by valid and enforceable patents or are effectively maintained as trade secrets. We intend,
from time to time, to apply for patents covering both our technologies and our products, while at other times, we only maintain such knowledge as trade secrets without applying
for patents, as we deem appropriate. However, existing and future patent applications may be challenged and are not guaranteed to result in the issuing of patents. Even if a patent
is obtained, it may not be sufficiently broad to prevent others from practicing our technologies or from developing competing products. Others, including Danisco and our current
and future collaborators and licensees, may independently develop similar or alternative technologies or design around our, Danisco’s or our current and future collaborators’ and
licensees’ patented technologies. In addition, Danisco, our current and future collaborators, licensees, or other third parties may challenge or invalidate our patents, or our patents
may fail to provide us with any competitive advantages. If any third party is able to gain intellectual property protections for technology similar to our own, they may be successful
in blocking us and our licensees from using the C1-cell protein production platform or our other technologies and/or commercializing products derived from them.
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We cannot ensure that any of our pending patent applications will result in issued patents, or even if issued, predict the breadth of the claims upheld in our and other
companies’ patents. Given that the degree of future protection for our proprietary rights is uncertain, we cannot ensure that we were the first to invent the inventions covered by
our pending patent applications, or that we were the first to file patent applications for these inventions or the patents we have obtained.
In addition, Dyadic will continue to review its existing and potential patent positions and rights. Based on our analysis if and when the commercial opportunities and
patent enforceability are questionable, we may abandon certain patents in some countries. There is a risk that we will abandon potentially valuable patents.
Litigation or other proceedings or third-party claims of intellectual property infringement could require us to spend significant time and resources and could prevent us and
our collaborators from commercializing our or their technologies and products or negatively impact our stock price.
Our commercial success depends in part on neither infringing patents and proprietary rights of third parties, nor breaching any licenses that we have entered into with
regard to our technologies and products. Others have filed, and in the future are likely to file, patent applications covering genes or gene fragments, genetic elements, screening,
gene expression and fermentation processes and other intellectual property that we may wish to utilize with the C1-cell protein production platform or our other technologies or
products and systems that are similar to those developed with its use. If these patent applications result in issued patents and we wish to use the claimed technology, we may need
to obtain a license from the appropriate third party.
Third parties do and may continue to assert that we and/or our current and future collaborators and licensees are employing their proprietary technology without
authorization. In addition, third parties may obtain patents in the future and claim that use of our technologies infringes these patents. We could incur substantial costs and
diversion of management and technical personnel in defending ourselves against any of these claims or enforcing our patents and other intellectual property rights. Parties making
claims against us may be able to obtain injunctive or other equitable relief, which could effectively block our ability to further develop, commercialize and sell products, and could
result in the award of substantial damages against us. If a claim of infringement against us is successful, we may be required to pay damages and obtain one or more licenses from
third parties. In the event that we are unable to obtain these licenses at a reasonable cost, we and/or current and future collaborators and licensees could encounter delays in
product commercialization while we attempt to develop alternative methods or products. Defense of any lawsuit or failure to obtain any of these licenses could prevent us from
commercializing available products.
In addition, unauthorized parties may attempt to steal, copy or otherwise obtain and use our C1 microbial strains, genetic elements, development and manufacturing
processes, other technology or products. Monitoring unauthorized use of our intellectual property is difficult, and we cannot be certain that the steps we have taken will prevent
unauthorized use of our technologies, particularly in certain foreign countries where the local laws may not protect our proprietary rights as fully as in the United States. Moreover,
third parties could practice our inventions in territories where we do not have patent protection. Such third parties may then try to import into the United States or other territories
products, or information leading to potentially competing products, made using our inventions in countries where we do not have patent protection for those inventions. If
competitors are able to use our technologies, our ability and our current and future collaborators’ and licensees’ ability to compete effectively could be harmed. Moreover, others
may independently develop and obtain patents for technologies that are similar to or superior to our technologies. If that happens, we may need to license these technologies, and
we may not be able to obtain licenses on reasonable terms, if at all, which could harm our business, financial condition and results of operations.
Confidentiality agreements with employees and others may not adequately prevent disclosures of trade secrets and other proprietary information.
We rely in part on trade secret protection to protect our confidential and proprietary information and processes. However, trade secrets are difficult to protect. We have
taken measures to protect our trade secrets and proprietary information, but these measures may not be effective. We require employees and consultants to execute confidentiality
agreements upon the commencement of an employment or consulting arrangement with us. These agreements generally require that all confidential information developed by the
individual or made known to the individual by us during the course of the individual’s relationship with us be kept confidential and not disclosed to third parties. These
agreements also generally provide that inventions conceived by the individual in the course of rendering services to us shall be our exclusive property. Nevertheless, our
proprietary information may be disclosed, third parties could reverse engineer our biocatalysts and others may independently develop substantially equivalent proprietary
information and techniques or otherwise gain access to our trade secrets. Costly and time-consuming litigation could be necessary to enforce and determine the scope of our
proprietary rights, and failure to obtain or maintain trade secret protection could adversely affect our competitive business position.
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Risks Related to Our Common Stock
The price of our shares of common stock is likely to be volatile, and you could lose all or part of your investment.
The trading price of our common stock has been, and is likely to continue to be, volatile. Biotechnology company stocks generally tend to experience extreme price
fluctuations. The valuations of many biotechnology companies without consistent product sales and earnings are extraordinarily high based on conventional valuation standards
such as price-to-earnings and price-to-sales ratios. These trading prices and valuations may not be sustained. Factors that may result in fluctuations in our stock price include, but
are not limited to, the following:
•
•
•
Changes in the public’s perception of the prospects of biotechnology companies;
Sales of our common stock in the public market by such stockholders or other significant stockholders, executive officers, or directors;
Announcements of new technological innovations, patents or new products or processes by us, Danisco or our current or future collaborators, licensees and
competitors;
Coverage of, or changes in financial estimates by us or securities and industry analysts;
Conditions or trends in the biotechnology industry;
Changes in investor interest in the areas in which we and/or our collaborators and licensees are applying our technologies, such as COVID-19;
Changes in the market valuations of other biotechnology companies;
Limitations or expanded uses in the areas within the biopharmaceutical or other industries into which we can apply our technologies and products;
• Announcements by us, Danisco or our collaborators and licensees relating to our relationships with third parties;
•
•
•
•
•
• Actual or anticipated changes in our growth rate relative to our competitors;
• Developments in domestic and international governmental policy or regulations;
•
Announcements by us, Danisco, our current and future collaborators and licensees, or our competitors of significant acquisitions, divestures, strategic partnerships,
license agreements, joint ventures or capital commitments;
The position of our cash, cash equivalents and marketable securities;
•
• Any changes in our debt position;
• Developments in patent or other proprietary rights held by us, Danisco or by others;
•
Negative effects related to the stock or business performance of Danisco, our current and future collaborators and licensees, or the abandonment of projects using
our technology by our collaborators and/or licensees;
Scientific risks inherent to emerging technologies such as the C1-cell protein production platform or our other technologies;
Set-backs, and/or failures, and or delays in our or our current and future collaborators’ and licensees’ R&D and commercialization programs;
•
•
• Delays or failure to receive regulatory approvals by us, Danisco and/or our current and future collaborators and licensees;
•
•
Loss or expiration of our or Danisco’s intellectual property rights;
Theft, misappropriation or expiration of owned or licensed proprietary and intellectual property, genetic and biological material owned by us and/or Danisco US, Inc.,
and VTT Technical Research Centre of Finland Ltd;
Lawsuits initiated by or against us, Danisco, or our current and future collaborators and licensees;
Period-to-period fluctuations in our operating results;
Future royalties from product sales, if any, by Danisco, our current or future strategic partners, collaborators or licensees;
Future royalties may be owed to Danisco by us, our collaborators, licenses, or sub-licensees under certain circumstances related to our Danisco Pharma License;
Short positions taken in our common stock;
Sales of our common stock or other securities in the open market;
Stock buy-back programs;
Stock splits; and
Decisions made by the board related to potential registration of Dyadic’s stock under the Securities Act of 1933, as amended (the "Securities Act”), and/or up listing
to another stock exchange.
•
•
•
•
•
•
•
•
•
If we were to become party to a securities class action suit, we could incur substantial legal fees and our management’s attention and resources could be diverted from
operating our business to responding to litigation.
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Our quarterly and annual operating results may be volatile.
Our quarterly and annual operating results have fluctuated in the past and are likely to do so in the future. These fluctuations could cause our stock price to vary
significantly or decline. Some of the factors that could impact our operating results include:
•
•
•
•
•
•
Expiration of or cancellations of our research contracts with current and future collaborators and/or licensees, which may not be renewed or replaced;
Setbacks or failures in our and our current and future collaborators’ and licensees’ research, development and commercialization efforts;
Setbacks, or delays in our research and development efforts to develop and produce biologics;
Setbacks, or delays in our research and development efforts to re-engineer the C1-cell protein production platform or our other technologies for their applications and
use in developing and producing biologics;
The speed, and success rate of our discovery and research and development efforts leading to potential licenses, or other forms of collaborations, access fees,
milestones and royalties;
The timing and willingness of current and future collaborators and licensees to utilize C1 to develop and commercialize their products which would result in potential
upfront fees, milestones and royalties;
• General and industry specific economic conditions, which may affect our current and future collaborators’ and licensees’ R&D expenditures;
•
The adoption and acceptance of the C1-cell protein production platform and our other technologies by biopharmaceutical and non-pharmaceutical companies and
regulatory agencies;
The addition or loss of one or more of the collaborative partners, grants, research funding, or licensees we are working with to further develop and commercialize our
technologies and products in the pharmaceutical industry;
•
The improvement and advances made by our competitors to CHO, E.coli, yeast, inset cells, plant and other expression systems;
The introduction by our competitors of new discovery and expression technologies competitive with the C1-cell protein production platform;
• Our ability to file, maintain and defend our intellectual property and to protect our proprietary information and trade secrets;
• Our ability to develop technology, products and processes that do not infringe on the intellectual property of third parties;
•
•
• Our ability to enter into new research projects, grants, licenses or other forms of collaborations and generate revenue from such parties;
•
•
Scientific risk associated with emerging technologies such as the C1-cell protein production platform;
Failure to bring on the necessary research and manufacturing capacity, e.g., CRO, CMO (contract manufacturing organization), and CDMO (contract development
and manufacturing organization), if required;
Uncertainty regarding
timing of research funding, grants or upfront
technologies, collaborations, license agreements or expanded license agreements; and
• Delays or failure to receive upfront fees, milestones and royalties and other payments.
license fees for new C1-cell protein production platform, our other
the
•
Due to the possibility of fluctuations in our revenues and expenses, we believe that quarter-to-quarter comparisons of our operating results are not necessarily a good
indication of our future performance. Our operating results in some quarters, or even in some years, may not meet the expectations of stock market analysts and investors,
potentially causing our stock price to decline.
We do not expect to pay cash dividends in the future.
We have never paid cash dividends on our stock and do not anticipate paying any dividends for the foreseeable future. The payment of dividends on our stock, if ever,
will depend on our earnings, financial condition and other business and economic factors deemed relevant for consideration by our board of directors. If we do not pay dividends,
our stock may be less valuable because a return on investment will only occur if and to the extent that our stock price appreciates.
Our anti-takeover defense provisions may deter potential acquirers and depress our stock price.
Certain provisions of our certificate of incorporation, bylaws and Delaware law, as well as certain agreements we have with our executives, could make it substantially
more difficult for a third party to acquire control of us. These provisions include the following:
• We may issue preferred stock with rights senior to those of our common stock;
• We have a classified board of directors;
• Action by written consent by stockholders is not permitted;
• Our board of directors has the exclusive right to fill vacancies and set the number of directors;
•
• We require advance notice for nomination of directors by our stockholders and for stockholder proposals.
Cumulative voting by our stockholders is not allowed; and
These provisions may discourage certain types of transactions involving an actual or potential change in control. These provisions may also limit our stockholders’
ability to approve transactions that they may deem to be in their best interests and discourage transactions in which our stockholders might otherwise receive a premium for their
stock over the current market price.
Concentration of ownership among our existing officers, directors and principal stockholders may prevent other stockholders from influencing significant corporate
decisions and depress our stock price.
Our executive officers, directors and principal stockholders (5% stockholders) together control approximately 35.1% of our 28,811,061 shares of outstanding common
stock as of December 31, 2023.
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Our Founder and Chief Executive Officer Mark Emalfarb, through the Mark A. Emalfarb Trust U/A/D October 1, 1987, as amended (the "MAE Trust”) of which he is the
trustee and beneficiary, owned approximately 15.7% of our outstanding common stock as of December 31, 2023. Further, the Francisco Trust U/A/D February 28, 1996 (the
"Francisco Trust”), whose beneficiaries are the descendants and spouse of Mr. Emalfarb, owned approximately 12.3% of our outstanding common stock as of December 31, 2023.
We have historically been partially controlled, managed and partially funded by Mr. Emalfarb, and affiliates of Mr. Emalfarb. Collectively, Mr. Emalfarb and stockholders affiliated
with Mr. Emalfarb controlled approximately 28.0% of our outstanding common stock as of December 31, 2023.
Mr. Emalfarb may be able to control or significantly influence all matters requiring approval by our stockholders, including the election of directors and the approval of
mergers or other business combination transactions. The interests of Mr. Emalfarb may not always coincide with the interests of other stockholders, and he may take actions that
advance his personal interests and are contrary to the desires of our other stockholders.
If our existing officers, directors and principal stockholders act together, they will be able to exert a significant degree of influence over our management and affairs and
over matters requiring stockholder approval, including the election of directors and approval of significant corporate transactions. In addition, this concentration of ownership may
delay or prevent a change in control and might affect the market price of our stock, even when a change may be in the best interests of all stockholders. Certain of our principal
stockholders may elect to increase their holdings of our common stock, which may have the impact of delaying or preventing a change of control. Moreover, the interests of this
concentration of ownership may not always coincide with our interests or the interests of other stockholders, and, accordingly, they could cause us to enter into transactions or
agreements, which we would not otherwise consider.
Future issuances of shares of our common stock may negatively affect our stock price.
The sale of additional shares of our common stock, or the perception that such sales could occur, could harm the prevailing market price of shares of our common stock.
These sales, or the possibility that these sales may occur, also might make it more difficult for us to sell equity securities in the future at a time and at a price that we deem
appropriate.
As of December 31, 2023, there were 28,811,061 shares of our common stock outstanding. Approximately 35.1% of these outstanding common shares are beneficially
owned or controlled by our executive officers, directors and principal stockholders.
Our common stock has a relatively small public float. As a result, sales of substantial amounts of shares of our common stock, or even the potential for such sales, may
materially and adversely affect prevailing market prices for our common stock. In addition, any adverse effect on the market price of our common stock could make it difficult for us
to raise additional capital through sales of equity securities.
The Company is exposed to credit risk and fluctuations in the values of its investment portfolio.
The Company’s investments can be negatively affected by liquidity, credit deterioration, financial results, market and economic conditions, political risk, sovereign risk,
interest rate fluctuations or other factors. As a result, the value and liquidity of the Company’s cash, cash equivalents, and marketable and non-marketable securities may fluctuate
substantially, which could result in significant losses and could have a material adverse impact on the Company’s financial condition and operating results.
We are a smaller reporting company, and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to
investors.
We are a smaller reporting company and are therefore entitled to rely on certain reduced disclosure requirements, such as an exemption from providing selected financial
data and executive compensation information. We are also exempt from the requirement to obtain an external audit on the effectiveness of internal control over financial reporting
provided in Section 404(b) of the Sarbanes-Oxley Act. These exemptions and reduced disclosures in our filings with the Securities and Exchange Commission due to our status as a
smaller reporting company mean our auditors do not review our internal control over financial reporting and may make it harder for investors to analyze our results of operations
and financial prospects. 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 prices may be more volatile.
Item 1B.
Unresolved Staff Comments
Not applicable.
Item 1C. Cybersecurity
Cybersecurity Risk Management and Strategy
We recognize the importance of assessing, identifying, and managing material risks associated with cybersecurity threats, as such term is defined in Item 106(a) of
Regulation S-K. These risks include, among other things, operational risks, the risk of intellectual property theft, fraud, harm to employees or third parties with which we conduct
business and violation of data privacy or security laws.
Identifying and assessing cybersecurity risk is integrated into our overall risk management systems and processes. We have established policies and controls for
assessing, identifying and managing material cybersecurity risks and responding to material cybersecurity incidents.
We routinely assess material cybersecurity risks, including potential unauthorized occurrences on, or conducted through, our information systems that may compromise
the confidentiality, integrity or availability of those systems or information maintained in them. We conduct periodic risk assessments to identify cybersecurity threats, as well as
assessments when there is a material change in our business practices that we believe could affect information systems that are vulnerable to cybersecurity threats. These risk
assessments include identifying reasonably foreseeable internal and external risks and the potential harm if the risks were to materialize. We conduct these risk assessments
directly and also periodically engage third-party providers to support these processes.
24
Following these risk assessments, we evaluate how to appropriately implement and maintain reasonable safeguards to mitigate identified risks; reasonably address any
identified gaps in existing safeguards; and regularly monitor the effectiveness of our safeguards. We have implemented cybersecurity tools, conducted employee training, and
monitored emerging laws and regulations related to data protection and information security. We may also [obligate] certain third-party business partners to certify that they can
implement and maintain appropriate security measures, consistent with all applicable laws, in connection with their work for us, and to promptly report any suspected breach of
their security measures that may affect the Company.
Cybersecurity events and data incidents are evaluated, assessed based on severity and prioritized for response and remediation. Under our incident response policies,
incidents are evaluated to determine materiality as well as operational and business impact and reviewed for privacy impact.
We have not, to date, experienced a cybersecurity incident that was determined to be material, although, like any technology provider, we have experienced incidents in
the past. Despite our cybersecurity efforts, we may not be successful in preventing or mitigating a cybersecurity incident that could have a material adverse effect on our business.
For additional information regarding whether any risks from cybersecurity threats are reasonably likely to materially affect our company, including our business strategy, results of
operations, or financial condition, please refer to Item 1A, "Risk Factors,” in this Annual Report on Form 10-K.
Cybersecurity Governance
Cybersecurity is an important part of our risk management processes and an area of focus for our board of directors and management team. Our board of directors has
delegated responsibility to the Audit Committee for the oversight of risks from cybersecurity threats. Members of the Audit Committee receive regular updates from senior
management, including leaders from our information technology, legal and compliance teams regarding matters of cybersecurity. This includes existing and new cybersecurity
risks, information on how management is addressing and/or mitigating those risks, cybersecurity incidents (if any) and the status on key information security initiatives.
Our Chief Executive Officer and Chief Financial Officer are principally responsible for overseeing the cybersecurity risk management program, in partnership with outside
consultants, as well as managing and responding to material cyber incidents if any occur. They will provide periodic briefings to the Audit Committee and to the Board of Directors
about our cybersecurity risks and activities, including cybersecurity incidents and responses, cybersecurity systems testing, third-party activities and related topics. In addition,
our policies for managing and responding to cybersecurity incidents include procedures for appropriate escalations to our Audit Committee Chair.
Item 2.
Properties
Leases
Jupiter, Florida Headquarters
The Company’s prior lease for its corporate headquarters located at 140 Intracoastal Pointe Dr. located in Jupiter Florida, expired on August 31, 2023. In August 2023, the
Company entered into a new lease comprising approximately 1,719 square feet of office space located at 1044 N US 1, Jupiter, Florida, commencing September 1, 2023
("Commencement Date”). Rent is subject to three percent (3%) annual increases, and the Company is responsible for certain common area maintenance charges and taxes
throughout the life of the lease. The lease has an initial term of three (3) years, following the Commencement Date with an option to extend for two (2) successive one (1) year
terms. The option to extend were not included in the lease term used in determining the right-of-use asset or lease liability, as the Company did not consider it reasonably certain
that it would exercise the option.
The Netherlands Office
The Company maintains a small satellite office in Wageningen, The Netherlands. The Company occupies a flexible office space for an annual rental rate of approximately
$4,800. The lease expires on January 31, 2025, and thereafter, the Company will reconsider the leased space to align with the future operations of the Company.
We believe that our current office spaces are adequate to meet our needs for the immediate future, and that, should it be needed, suitable additional space is available to
accommodate any expansion of our operations, but such space may not be available in the same building if and when such space is needed.
Item 3.
Legal Proceedings
We are not currently involved in any litigation that we believe could have a materially adverse effect on our financial condition or results of operations. There is no action,
suit, proceeding, inquiry or investigation before or by any court, public board, government agency, self-regulatory organization or body pending or, to the knowledge of the
executive officers of our Company or any of our subsidiaries, threatened against or affecting our Company, our common stock, any of our subsidiaries or of our Company’s or our
Company’s subsidiaries’ officers or directors in their capacities as such, in which an adverse decision could have a material adverse effect.
However, from time to time, we may become involved in various lawsuits and legal proceedings which arise in the ordinary course of business. Litigation is subject to
inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm our business.
Item 4.
Mine Safety Disclosures
Not applicable for our operations.
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PART II
Item 5.
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchase of Equity Securities
Market Information
As of December 31, 2023, Dyadic had two classes of capital stock authorized, common stock and preferred stock. Effective April 17, 2019, our common stock began trading
on the NASDAQ Stock Market LLC’s NASDAQ Capital Market, under the symbol "DYAI”. There were no shares of preferred stock outstanding for the reported period. The
number of record holders of our common stock as of December 31, 2023 was 50, including The Depository Trust Company, which holds shares of our common stock on behalf of
an indeterminate number of beneficial owners. We have never declared or paid any dividends in the past. Any future determination to pay dividends will be at the discretion of our
Board of Directors (the "Board”).
Securities Authorized for Issuance Under Equity Compensation Plans
See Part III, Item 12.
Equity Performance Graph
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.
Recent Sales of Unregistered Securities
None.
Issuer Purchases of Equity Securities
None.
Item 6.
[Reserved]
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Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of financial condition and results of operations should be read in conjunction with the financial statements and the notes to
those statements appearing in this Annual Report. Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report, including
information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks, assumptions and uncertainties. Important factors
that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and
analysis include, but not limited to those set forth in "Item 1A. Risk Factors” in this Annual Report. All forward-looking statements included in this Annual Report are based on
information available to us as of the time we file this Annual Report and, except as required by law, we undertake no obligation to update publicly or revise any forward-
looking statements.
Overview
Description of Business
Dyadic International, Inc. ("Dyadic”, "we”, "us”, "our”, or the "Company”) is a global biotechnology company based in Jupiter, Florida with operations in the United
States and a satellite office in the Netherlands, and it utilizes several third-party consultants and research organizations to carry out the Company’s activities. Over the past two
plus decades, the Company has developed a gene expression platform for producing commercial quantities of industrial enzymes and other proteins, and has previously licensed
this technology to third parties, such as Abengoa Bioenergy SA, BASF SE, Codexis, Inc. and others, for use in industrial (non-pharmaceutical) applications. This technology is
based on the Thermothelomyces heterothallica (formerly known as Myceliophthora thermophila) fungus, which the Company named C1.
On December 31, 2015, the Company sold its industrial technology business to Danisco USA ("Danisco”), the industrial biosciences business of DuPont (NYSE: DD) (the
"DuPont Transaction”). As part of the DuPont Transaction, Dyadic retained co-exclusive rights to the C1-cell protein production platform for use in all human and animal
pharmaceutical applications, and currently the Company has the exclusive ability to enter into sub-license agreements (subject to the terms of the license and to certain exceptions)
for use in all human and animal pharmaceutical applications. Danisco retained certain rights to utilize the C1-cell protein production platform in pharmaceutical applications,
including the development and production of pharmaceutical products, for which it will be required to make royalty payments to Dyadic upon commercialization. In certain
circumstances, Dyadic may owe a royalty to either Danisco or certain licensors of Danisco, depending upon whether Dyadic elects to utilize certain patents either owned by
Danisco or licensed in by Danisco.
After the DuPont Transaction, the Company has been building innovative microbial platforms to address the growing demand for global protein bioproduction and unmet
clinical needs for effective, affordable, and accessible biopharmaceutical products for human and animal health and for other biologic products for use in non-pharmaceutical
applications.
The C1-cell protein production platform is a robust and versatile thermophilic filamentous fungal expression system for the development and production of biologic
products including enzymes and other proteins for human and animal health. Some examples of human and animal vaccines and drugs which have the potential to be produced
from C1-cells are protein antigens, ferritin nanoparticles, virus-like particles ("VLPs”), monoclonal antibodies ("mAbs”), Bi/Tri-specific antibodies, Fab antibody fragments, Fc-
fusion proteins, as well as other therapeutic enzymes and proteins. The Company is involved in multiple funded research collaborations with animal and human pharmaceutical
companies which are designed to leverage its C1-cell protein production platform to develop innovative vaccines and drugs, biosimilars and/or biobetters.
The Company also developed the Dapibus™ thermophilic filamentous fungal based microbial protein production platform to enable the rapid development and large-scale
manufacture of low-cost proteins, metabolites, and other biologic products for use in non-pharmaceutical applications, such as food, nutrition, and wellness.
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Critical Accounting Estimates
The preparation of these consolidated financial statements in accordance with U.S. generally accepted accounting principles ("GAAP”) requires management to make
estimates that affect the reported amount of assets and liabilities and related disclosure of contingent assets and liabilities at the date of our consolidated financial statements and
the reported amounts of revenues and expenses during the applicable period. Actual results may differ from these estimates under different assumptions or conditions. Such
differences could be material to the consolidated financial statements.
We define critical accounting estimates as those that are reflective of significant judgments and uncertainties and which may potentially result in materially different
results under different assumptions and conditions. In applying these critical accounting estimates, our management uses its judgment to determine the appropriate assumptions
to be used in making certain estimates. These estimates are subject to an inherent degree of uncertainty. Our critical accounting estimates include the following:
Revenue Recognition
The Company has no products approved for sale. All our revenue to date has been research revenue from third-party collaborations and government grants, as well as
revenue from sublicensing agreements and collaborative arrangements, which may include upfront payments, options to obtain a license, payment for research and development
services, milestone payments and royalties, in the form of cash or non-cash considerations (e.g., minority equity interest).
Revenue related to research collaborations and agreements: The Company typically performs research and development services as specified in each respective
agreement on a best-efforts basis, and recognizes revenue from research funding under collaboration agreements in accordance with the 5-step process outlined in ASC Topic 606
("Topic 606”): (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction
price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. We recognize revenue when we satisfy a
performance obligation by transferring control of the service to a customer in an amount that reflects the consideration that we expect to receive. Depending on how the
performance obligation under our license and collaboration agreements is satisfied, we recognize the revenue either at a point in time or over time by using the input method under
Topic 606 to measure the progress toward complete satisfaction of a performance obligation.
Under the input method, revenue will be recognized based on the entity’s efforts or inputs to the satisfaction of a performance obligation (e.g., resources consumed, labor
hours expended, costs incurred, or time elapsed) relative to the total expected inputs to the satisfaction of that performance obligation. The Company believes that the cost-based
input method is the best measure of progress to reflect how the Company transfers its performance obligation to a customer. In applying the cost-based input method of revenue
recognition, the Company uses actual costs incurred relative to budgeted costs to fulfill the performance obligation. These costs consist primarily of full-time equivalent effort and
third-party contract costs. Revenue will be recognized based on actual costs incurred as a percentage of total budgeted costs as the Company completes its performance
obligations.
A cost-based input method of revenue recognition requires management to make estimates of costs to complete the Company’s performance obligations. In making such
estimates, significant judgment is required to evaluate assumptions related to cost estimates. The cumulative effect of revisions to estimated costs to complete the Company’s
performance obligations will be recorded in the period in which changes are identified and amounts can be reasonably estimated. A significant change in these assumptions and
estimates could have a material impact on the timing and amount of revenue recognized in future periods.
Revenue related to grants: The Company may receive grants from governments, agencies, and other private and not-for-profit organizations. These grants are intended to
be used to fund the Company’s research collaborations partially or fully, including opportunities and projects that the Company is pursuing with certain collaborators. However,
most, if not all, of such potential grant revenues, if received, is expected to be earmarked for third parties to advance the research required, including preclinical and clinical trials for
vaccines and/or antibodies candidates.
Revenue related to sublicensing agreements:
If the sublicense to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company
recognizes revenue allocated to the license when technology is transferred to the customer and the customer can use and benefit from the license.
Customer options: If the sublicensing agreement includes customer options to purchase additional goods or services, the Company will evaluate if such options are
considered material rights to be deemed as separate performance obligations at the inception of each arrangement.
Milestone payments: At the inception of each arrangement that includes development, commercialization, and regulatory milestone payments, the Company evaluates
whether the achievement of the milestones is considered probable and estimates the amount to be included in the transaction price. If the milestone payment is in exchange for a
sublicense and is based on the sublicensee’s subsequent sale of product, the Company recognizes milestone payment by applying the accounting guidance for royalties. To date,
the Company has not recognized any milestone payment revenue resulting from any of its sublicensing arrangements.
Royalties: With respect to licenses deemed to be the predominant item to which thesales-based royalties relate, including milestone payments based on the level of sales,
the Company recognizes revenue at the later of (i) when the related sales occur or (ii) when the performance obligation to which some or all of the royalty has been allocated has
been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from any of its sublicensing arrangements.
We invoice customers based on our contractual arrangements with each customer, which may not be consistent with the period that revenues are recognized. When there
is a timing difference between when we invoice customers and when revenues are recognized, we record either a contract asset (unbilled accounts receivable) or a contract liability
(deferred research and development obligations), as appropriate. If upfront fees or considerations related to sublicensing agreement are received prior to the technology transfer,
the Company will record the amount received as deferred revenue from licensing agreement.
We are not required to disclose the value of unsatisfied performance obligations for (i) contracts with an original expected length of one year or less and (ii) contracts for
which we recognize revenue at the amount to which we have the right to invoice for services performed.
The Company adopted a practical expedient to expense sales commissions when incurred because the amortization period would be one year or less.
28
Accrued Research and Development Expenses
In order to properly record services that have been rendered but not yet billed to the Company, we review open contracts and purchase orders, communicate with our
personnel and we estimate the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of the actual
cost. The majority of our service providers invoice us monthly or quarterly in arrears for services performed or when contractual milestones are met. We make estimates of our
accrued expenses as of each balance sheet date in our consolidated financial statements based on facts and circumstances known to us at that time. We periodically confirm the
accuracy of our estimates with the service providers and adjust if necessary. Examples of accrued research and development expenses include amounts owed to contract research
organizations, to service providers in connection with research and development activities.
Stock-Based Compensation
We have granted stock options to employees, directors and consultants. The fair value of each option award is estimated on the date of grant using the Black-Scholes
option-pricing model. The Black-Scholes model considers volatility in the price of our stock, the risk-free interest rate, the estimated life of the option, the closing market price of
our stock and the exercise price. For purposes of the calculation, we assumed that no dividends would be paid during the life of the options. We also used the weighted-average
vesting period and contractual term of the option as the best estimate of the expected life of a new option, except for the options granted to the CEO (i.e., 5 or 10 years) and certain
contractors (i.e., 1 or 3 years). The expected stock price volatility was calculated based on the Company’s own volatility since the DuPont Transaction. The Company reviews its
volatility assumption on an annual basis and has used the Company’s historical volatilities since 2016, as the DuPont Transaction resulted in significant changes in the Company’s
business and capital structure.
The estimates utilized in the Black-Scholes calculation involve inherent uncertainties and the application of management judgment. These estimates are neither predictive
nor indicative of the future performance of our stock. As a result, if other assumptions had been used, our recorded share-based compensation expense could have been materially
different from that reported. In addition, because some of the performance-based options issued to employees, consultants and other third-parties vest upon the achievement of
certain milestones, the total ultimate expense of share-based compensation is uncertain.
Accounting for Income Taxes
The Company accounts for income taxes under the asset and liability method in accordance with ASC Topic 740, "Income Taxes”. Under this method, income tax expense
/(benefit) is recognized for: (i) taxes payable or refundable for the current year and (ii) deferred tax consequences of temporary differences resulting from matters that have been
recognized in an entity’s financial statements or tax returns. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years
in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the results of
operations in the period that includes the enactment date. A valuation allowance is provided to reduce the deferred tax assets reported if based on the weight of the available
positive and negative evidence, it is more likely than not some portion or all the deferred tax assets will not be realized.
In determining taxable income for the Company’s consolidated financial statements, we are required to estimate income taxes in each of the jurisdictions in which we
operate. This process requires the Company to make certain estimates of our actual current tax exposure and assessment of temporary differences between the tax and financial
statement recognition of revenue and expense. In evaluating the Company’s ability to recover its deferred tax assets, the Company must consider all available positive and
negative evidence including its past operating results, the existence of cumulative losses in the most recent years and its forecast of future taxable income. Significant management
judgment is required in determining our provision for income taxes, deferred tax assets and liabilities and any valuation allowance recorded against our net deferred tax assets.
The Company is required to evaluate the provisions of ASC 740 related to the accounting for uncertainty in income taxes recognized in a company’s financial statements.
ASC 740 prescribes a comprehensive model for how a company should recognize, present, and disclose uncertain positions that the company has taken or expects to take in its tax
return. For those benefits to be recognized, a tax position must be more-likely-than-not to be sustained upon examination by taxing authorities. Differences between tax positions
taken or expected to be taken in a tax return and the net benefit recognized and measured pursuant to the interpretation are referred to as "unrecognized benefits.” A liability
should be recognized (or amount of net operating loss carry forward or amount of tax refundable is reduced) for unrecognized tax benefits, because it represents a company’s
potential future obligation to the taxing authority for a tax position that was not recognized because of applying the provision of ASC 740.
The Company classifies accrued interest and penalties related to its tax positions as a component of income tax expense. The Company currently is not subject to U.S.
federal, state and local tax examinations by tax authorities for the years before 2017. See Note 4 to the Consolidated Financial Statements.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements.
Recent Accounting Pronouncements
See Note 1 to the Consolidated Financial Statements for information about recent accounting pronouncements.
29
Results of Operations
Year Ended December 31, 2023 Compared to the Year Ended December 31, 2022
Revenue and Cost of Revenue
The following table summarizes the Company’s revenue and cost of research and development revenue for the years ended December 31, 2023 and 2022:
Research and development revenue
License revenue
Cost of research and development revenue
Year Ended December 31,
2023
2022
$
$
$
2,545,865 $
352,941 $
1,975,849 $
2,683,244
247,059
2,123,193
For the years ended December 31, 2023 and 2022, the Company’s revenue was generated from sixteen and fourteen collaborations, respectively. The decrease in revenue
and cost of research and development revenue was due to higher individual contract amounts on certain research funding and related work performed during 2022. The license
revenue for the year ended December 31, 2023 was in connection with the Janssen license agreement, and for the year ended December 31, 2022 was in connection with the
Phibro/Abic and Janssen license agreements.
Research and Development Expenses
Research and development costs are expensed as incurred and primarily include salary and benefits of research personnel, third-party contract research organization
services and supply costs.
Research and development expenses for the year ended December 31, 2023 decreased to $3.3 million compared to $4.5 million for the year ended December 31, 2022. The
decrease primarily reflected the winding down of activities related to the Company’s Phase 1 clinical trial of DYAI-100 COVID-19 vaccine candidate.
General and Administrative Expenses
General and administrative expenses for the year ended December 31, 2023, decreased to $5.8 million compared to $6.4 million for the year ended December 31, 2022. The
decrease principally reflected a decrease in management incentives of $466,000, business development and investor relations costs of $219,000, and legal expenses of $39,000,
partially offset by increases insurance premiums of $96,000, and other increases of $24,000.
Foreign Currency Exchange
Foreign currency exchange loss for the year ended December 31, 2023 was $38,000 compared to $50,000 for the year ended December 31, 2022. The decrease reflected the
currency fluctuation of the Euro in comparison to the U.S. dollar.
Interest Income
Interest income for the year ended December 31, 2023, increased to $417,000 compared to $180,000 for the year ended December 31, 2022. The increase was primarily due to
an increase in interest rates and yield on the Company’s investment grade securities, which are classified as held-to-maturity.
Other Income
For the year ended December 31, 2023, the Company had a gain of approximately $1.0 million from the sale of the Company’s equity interest in Alphazyme, LLC. For the
year ended December 31, 2022, the Company received a settlement payment of $250,000 from the termination of a proposed license and collaboration.
Income Taxes
The Company had net operating loss ("NOL”) carryforwards available as of December 31, 2023 and 2022, in the amount of approximately $45.9 million and $44.0 million,
respectively. Approximately $42.9 million of the net operating loss carryforwards will be carried forward indefinitely and will be available to offset 80% of taxable income. The
remaining amount of the net operating loss carryforwards will expire at varying dates through 2037.
Net Loss
Net loss for the year ended December 31, 2023 was $6.8 million compared to a net loss of $9.7 million for the year ended December 31, 2022. The decrease in net loss of
$2.9 million was principally due to decreases in research and development expenses of $1.2 million, general and administrative expenses of $605,000, and partially offset by an
increase in other income of $768,000.
Liquidity and Capital Resources
Our primary source of cash to date has been the cash received from the DuPont Transaction in 2015, interest income received from investment grade securities, revenues
from our research collaboration agreements and license agreements, and funds from the exercise of employee stock options. For the year ended December 31, 2023, the Company
received $1.3 million from the sale of its equity interest in Alphazyme, LLC and $600,000 upfront payment for a product development and licensing agreement.
30
On March 8, 2024, the Company sold and issued an aggregate principal amount of $6.0 million of its 8.0% Senior Secured Convertible Promissory Notes due March 8, 2027
(the "Convertible Notes”) in a private placement in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities
Act”). The purchasers of the Convertible Notes include immediate family members and family trusts related to Mark Emalfarb, our President and Chief Executive Officer and a
member of our Board of Directors, including The Francisco Trust, an existing holder of more than 5% of the Company’s outstanding common stock, (collectively, the
"Purchasers”). The net proceeds from the sale of the Convertible Notes, after deducting offering expenses, are approximately $5,850,000. The Company intends to use the net
proceeds from the offering of the Convertible Notes for working capital and general corporate purposes.
The Convertible Notes will be senior, secured obligations of Dyadic and its affiliates, and interest will be payable quarterly in cash on the principal amount equal to 8% per
annum. The Convertible Notes will mature on March 8, 2027 (the "Maturity Date”), unless earlier converted, repurchased, or redeemed in accordance with the terms of the
Convertible Notes.
The Convertible Notes will be convertible into shares of Dyadic’s Class A common stock (the "Common Stock”), at the option of the holders of the Convertible Notes (the
"Noteholders”) at any time prior to the Maturity Date. The conversion price is $1.79 per share of the Common Stock, which is equal to 125% of the trailing 30-day VWAP of the
Common Stock ending on the trading day immediately preceding the date of the securities purchase agreement. For more information regarding the Convertible Notes, including
the covenants related thereto see Note 8 to the Consolidated Financial Statements.
This private placement funding strengthened our financial position, and it will support our near term revenue growth and accelerate our strategic objective of
commercialization opportunities for pharmaceutical and non-pharmaceutical applications. The Company has received successful top-line results for the Phase 1 clinical trial of
DYAI-100, and we do not plan to continue Phase 2/3 clinical trials unless funding is secured.
Our ability to achieve profitability depends on many factors, including our scientific results and our ability to continue to obtain funded research and development
collaborations from industry and government programs, as well as sub-license agreements. We may continue to incur substantial operating losses even if we begin to generate
revenues from research and development and licensing. Our primary future cash needs are expected to be for general operating activities, including our business development and
research expenses, as well as legal and administrative costs as an SEC reporting and NASDAQ listed company. Our future cash requirements will depend on many factors,
including those factors discussed under Item 1A. Risk Factors.
As of December 31, 2023, we had an accumulated deficit of $80.3 million. We expect to incur losses and have negative net cash flows from operating activities as we
continue developing our microbial platforms and related products, and as we expand our pipeline and engage in further research and development activities for internal products as
well as for our third-party collaborators and licensees. The success of the Company depends on its ability to develop its technologies and products to the point of regulatory
approval and subsequent revenue generation or through sublicensing of the Company’s technologies and products, to raise enough capital to finance these developmental
efforts.
We expect our existing cash and cash equivalents and cash raised from the Convertible Notes, investments in debt securities, and operating cash flows will be sufficient
to meet our operational, business, and other liquidity requirements for at least the next twelve (12) months from the date of issuance of the financial statements contained in this
Form 10-K. However, we have based this estimate on assumptions that may prove to be wrong, and our operating plan may change because of many factors currently unknown. In
the event our financing needs are not able to be met by our existing cash, cash equivalents and investments, we would seek to raise additional capital through strategic financial
opportunities that could include, but are not limited to, future public or private equity offerings, collaboration agreements, and/or other means. Any amounts raised may be used
for the further development and commercialization of product candidates, and for other working capital purposes. There is no guarantee that any of these strategic or financing
opportunities will be executed or realized on favorable terms, if at all, and some could be dilutive to existing shareholders.
At December 31, 2023, cash and cash equivalents were $6.5 million compared to $5.8 million at December 31, 2022. The carrying value of investment grade securities,
including accrued interest at December 31, 2023 was $0.8 million compared to $6.9 million at December 31, 2022.
Net cash used in operating activities for the year ended December 31, 2023 of $6.7 million resulted from a net loss of $6.8 million adjusted for share-based compensation
expenses of $1.2 million, partially offset by sale of our investment in Alphazyme of $1.0 million, and changes in operating assets and liabilities of $0.1 million.
Net cash used in operating activities for the year ended December 31, 2022 of $8.1 million resulted from a net loss of $9.7 million adjusted for share-based compensation
expenses of $1.9 million, offset by changes in operating assets and liabilities of $0.3 million.
Net cash provided by investing activities for the year ended December 31, 2023 was $7.5 million compared to net cash used in investing activities of $2.4 million for the
year ended December 31, 2022. Cash flows from investing activities in 2023 were primarily related to proceeds from maturities, net of purchases of investment grade debt securities,
and proceeds from the sale of investment in Alphazyme. Cash flows from investing activities in 2022 were primarily related to proceeds from maturities, net of purchases of
investment grade debt securities.
There was no net cash provided by financing activities for the year ended December 31, 2023 compared to $544,000 for the year ended December 31, 2022. Cash flows from
financing activities in 2022 were primarily related to proceeds received from the exercise of stock options.
Item 7A.
Quantitative and Qualitative Disclosures about Market Risk
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.
31
Item 8.
Financial Statements and Supplementary Data
The Consolidated Financial Statements and supplementary data required by this item are presented elsewhere in this report beginning on page F-1, in the order shown
below:
Report of Independent Registered Public Accounting Firm (PCAOB ID 173)
Report of Independent Registered Public Accounting Firm (PCAOB ID 199)
Consolidated Balance Sheets as of December 31, 2023 and 2022 Consolidated Statements of Operations for the years ended December 31, 2023, 2022
Consolidated Statements of Stockholders' Equity for the years ended December 31, 2023 and 2022
Consolidated Statements of Cash Flows for the years ended December 31, 2023 and 2022
Notes to Consolidated Financial Statements
Item 9.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
None.
Item 9A.
Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, evaluated the effectiveness of our disclosure controls and
procedures as of December 31, 2023. The term "disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as
amended, or the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the
reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC rules and forms. Based on the
evaluation of our disclosure controls and procedures as of December 31, 2023, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our
disclosure controls and procedures were effective.
Management’s Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate "internal control over financial reporting,” as defined in Rules 13a-15(f) and 15d-15(f) under the
Exchange Act. Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2023 based on the criteria set forth in the Internal
Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on the assessment, our management has
concluded that our internal control over financial reporting was effective as of December 31, 2023. This Annual Report does not include an attestation report of our independent
registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by our independent registered public
accounting firm pursuant to the rules of the SEC that permit us to provide only management’s report in this Annual Report because we are a "smaller reporting company.”
Changes in Internal Controls Over Financial Reporting
There were no changes in our internal control over financial reporting identified in connection with the evaluation required by Rules 13a-15(d) and 15d-15(d) of the
Exchange Act that occurred during the year ended December 31, 2023 that materially affected, or are reasonably likely to materially affect, our internal control over financial
reporting.
Inherent Limitation on Effectiveness of Controls
A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met.
Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of
the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our Company
have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of a simple error or
mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The
design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed
in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or because the degree of
compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and
not be detected.
32
Item 9B.
Other Information
Insider Trading Arrangements
During the quarter ended December 31, 2023, none of our directors or officers (as defined in Rule 16a-1 under the Securities Exchange Act of 1934, as amended) adopted
or terminated a "Rule 10b5-1 trading arrangement” or a "non-Rule 10b5-1 trading arrangement” (each as defined in Item 408(a) and (c), respectively, of Regulation S-K).
Item 9C. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections
Not applicable.
PART III
Item 10.
Directors, Executive Officers and Corporate Governance
The information required by this item is incorporated by reference to the Company’s definitive proxy statement relating to the 2024 annual meeting of shareholders. The
definitive proxy statement will be filed with the Securities and Exchange Commission within 120 days after the end of the 2023 fiscal year.
Item 11.
Executive Compensation
The information required by this item is incorporated by reference to the Company’s definitive proxy statement relating to the 2024 annual meeting of shareholders. The
definitive proxy statement will be filed with the Securities and Exchange Commission within 120 days after the end of the 2023 fiscal year.
Item 12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The information required by this item is incorporated by reference to the Company’s definitive proxy statement relating to the 2024 annual meeting of shareholders. The
definitive proxy statement will be filed with the Securities and Exchange Commission within 120 days after the end of the 2023 fiscal year.
Item 13.
Certain Relationships and Related Transactions, and Director Independence
The information required by this item is incorporated by reference to the Company’s definitive proxy statement relating to the 2024 annual meeting of shareholders. The
definitive proxy statement will be filed with the Securities and Exchange Commission within 120 days after the end of the 2023 fiscal year.
Item 14.
Principal Accounting Fees and Services
The information required by this item is incorporated by reference to the Company’s definitive proxy statement relating to the 2024 annual meeting of shareholders. The
definitive proxy statement will be filed with the Securities and Exchange Commission within 120 days after the end of the 2023 fiscal year.
33
Item 15.
Financial Statement and Exhibits
(a) Financial Statement
PART IV
Our financial statements and related notes thereto are listed and included in this Annual Report on Form 10-K beginning on page F-1.
(b) Exhibits
Exhibit
No.
3.1#
3.2#
4.1#
4.2#
4.3#
10.1**#
10.2**#
10.2.1**
10.2.2**
10.3**#
10.4**#
10.5**#
10.5.1**#
10.6**#
10.7**#
10.8**#
10.9**#
10.10#
10.11†#
10.12†#
10.12.1†#
10.13†#
10.13.1†#
10.14†#
10.15†#
Description of Exhibit
Restated Certificate of Incorporation dated November 1, 2004
Third Amended and Restated Bylaws dated March 28, 2023
Specimen Stock Certificate Evidencing Shares of Common Stock
Description of Registered Securities
Senior Secured Convertible Promissory Note due March 8, 2027, dated March 8, 2024
Dyadic International, Inc. 2011 Equity Incentive Plan
Dyadic International, Inc. 2021 Equity Incentive Plan
Form of Stock Option Agreement Pursuant to the Dyadic International, Inc. 2021 Equity
Incentive Plan
Form of Restricted Stock Unit Agreement Pursuant to the Dyadic International, Inc. 2021
Equity Incentive Plan
Form of Restricted Stock Unit Agreement Pursuant to the Dyadic International, Inc. 2011
Equity Incentive Plan
Form of Stock Option Agreement Pursuant to the Dyadic International, Inc. 2011 Equity
Incentive Plan
Employment Agreement, dated June 16, 2016, and First Amendment dated January 23, 2017,
by and between Dyadic International, Inc. and Mark A. Emalfarb
Second Amendment to Employment Agreement between Dyadic International, Inc. and
Mark A. Emalfarb, dated as of November 12, 2019
Consulting Agreement, dated January 1, 2016, by and between Dyadic Netherlands B.V.
and Sky Blue Biotech kft on behalf of Ronen Tchelet
Compensation Letter, dated March 26, 2018, by and between Dyadic International, Inc. and
Ping W. Rawson
Employment Agreement between Dyadic International Inc. and Joseph Hazelton dated
November 9, 2021
Form of Director and Officer Indemnification Agreement
Lease Agreement with Jupiter Harbour Office, LLC dated August 19, 2023
Pharma License Agreement with Danisco US, Inc. dated December 31, 2015
Commission Contract with VTT Technical Research Centre of Finland Ltd dated September
2, 2016
Commission Contract with VTT Technical Research Centre of Finland Ltd dated June 28,
2019
Service Framework Agreement with Biotechnology Developments for Industry in
Pharmaceuticals, S.L.U. dated June 30, 2017
Amendment No. 1 dated July 26, 2021, to the Service Framework Agreement dated June 30,
2017
Incorporated by Reference
Form
10-12G
8-K
10-12G
10-K
8-K
10-12G
Original No.
3.1
3.1
4.1
4.2
4.1
10.2
4.3
Date Filed
January 14, 2019
March 29, 2023
January 14, 2019
March 30, 2020
March 11, 2024
January 14, 2019
August 12, 2021
S-8
10-12G
10-12G
10-12G
8-K
10-12G
10-12G
8-K
10-12G
10-Q
10-12G
10-12G
8-K
10-Q
8-K
10.3
10.4
10.5
10.1
10.7
10.9
10.1
10.10
10.1
10.12
10.13
10.1
10.2
10.3
January 14, 2019
January 14, 2019
January 14, 2019
November 13, 2019
January 14, 2019
January 14, 2019
November 9, 2021
January 14, 2019
November 8, 2023
January 14, 2019
January 14, 2019
July 5, 2019
November 8, 2023
July 27, 2021
License Agreement with VTT Technical Research Centre of Finland Ltd dated July 17, 2017
Joint Development Agreement with Leprino Foods Company, dated May 12, 2022
10-12G
8-K
10.17
10.1
January 14, 2019
May 11, 2022
34
Filed
Herewith
x
x
10.16†#
Research and Commercialization Collaboration Agreement with Serum Institute of India Pvt. Ltd., dated May 7, 2019
10.17†#
Non-Exclusive Sublicense Agreement among Dyadic International, Inc., Alphazyme, LLC, dated May 5, 2019
10.17.1†#
Amended and Restated Non-Exclusive Sublicense Agreement among Dyadic International, Inc., Alphazyme, LLC, dated June 24, 2020
10.18#
Master Services Agreement and Work Order, between Dyadic International (USA), Inc. and CR2O B.V., Dated May 28, 2021
10.19†#
Alphazyme Sale Agreement dated January 18, 2023
10.20†#
RUBIC License Agreement dated April 6, 2023
10.21†#
Inzyme Development and Exclusive License Agreement, effective September 18, 2023
10.22#
10.23#
10.24#
10.25#
21.1
23.1
23.2
24.1
31.1
31.2
32.1^
32.2^
97
101.INS
101.SCH
101.CAL
101.DEF
101.LAB
101.PRE
104
Securities Purchase Agreement Relating to the Senior Secured Convertible Promissory Note dated March 8, 2024
Registration Rights Agreement Relating to the Senior Secured Convertible Promissory Note dated March 8, 2024
Security Agreement Relating to the Senior Secured Convertible Promissory Note dated March 8, 2024
Subsidiary Guarantee Relating to the Senior Secured Convertible Promissory Note dated March 8, 2024
Subsidiaries of the Registrant
Consent of Independent Registered Public Accounting Firm - Crowe LLP
Consent of Independent Registered Public Accounting Firm - Mayer Hoffman McCann P.C.
Power of Attorney (included on signature page)
Certification of Chief Executive Officer of Dyadic International, Inc, Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
Certification of Chief Financial Officer of Dyadic International, Inc. Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
Certification of Chief Executive Officer of Dyadic International, Inc. Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
Certification of Chief Financial Officer of Dyadic International, Inc. Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
Policy Related to Recovery of Erroneously Awarded Compensation
Inline XBRL Instance Document
Inline XBRL Taxonomy Extension Schema Document
Inline XBRL Taxonomy Extension Calculation Linkbase Document
Inline XBRL Taxonomy Extension Definition Linkbase Document
Inline XBRL Taxonomy Extension Labels Linkbase Document
Inline XBRL Taxonomy Extension Presentation Linkbase Document
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
Legend:
** Identifies a management contract or compensatory plan or arrangement.
† Certain provisions of this exhibit have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K.
# Previously filed with the SEC.
^ Furnished herewith.
Item 16.
Form 10-K Summary
Not applicable.
35
10.1
10.1
10.1
8-
K
8-
K
8-
K
8-
K 10.1
8-
K 10.1
8-
K 10.1
8-
K 10.1
8-
K 10.1
8-
K 10.2
8-
K 10.3
8-
K 10.4
May 8,
2019
May 8,
2019
June 29,
2020
June 3,
2021
January
23, 2023
April 6,
2023
September
19, 2023
March 11,
2024
March 11,
2024
March 11,
2024
March 11,
2024
x
x
x
^
x
x
x
x
x
x
x
x
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
March 28, 2024
March 28, 2024
DYADIC INTERNATIONAL, INC.
By:
By:
/s/ Mark A. Emalfarb
Mark A. Emalfarb
President and Chief Executive Officer
(Principal Executive Officer)
/s/ Ping W. Rawson
Ping W. Rawson
Chief Financial Officer
(Principal Financial Officer and Principal Accounting Officer)
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Mark A. Emalfarb and Ping W. Rawson, jointly
and severally, his or her attorneys-in-fact, each with the power of substitution, for him or her in any and all capacities, to sign any amendments to this Annual Report on Form 10-
K, and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, hereby ratifying and confirming all that
each of said attorneys-in-fact, or his substitute or substitutes, may do or cause to be done by virtue hereof.
Pursuant to the requirements of Securities Exchange Act of 1934, as amended, this report has been signed below by the following persons on behalf of the registrant in
the capacities and on the dates indicated.
Signature
Title
/s/ Mark A. Emalfarb
Mark A. Emalfarb
/s/ Ping W. Rawson
Ping W. Rawson
/s/ Patrick Lucy
Patrick Lucy
/s/ Jack L. Kaye
Jack L. Kaye
/s/ Seth J. Herbst
Seth J. Herbst, MD
/s/Arindam Bose
Arindam Bose, Ph.D.
/s/Barry C. Buckland
Barry C. Buckland, Ph.D.
/s/ Michael P. Tarnok
Michael P. Tarnok
Chief Executive Officer, Director
(Principal Executive Officer)
Chief Financial Officer
(Principal Financial Officer and Principal Accounting Officer)
Chairman, Director
Director
Director
Director
Director
Director
36
Date
March 28, 2024
March 28, 2024
March 28, 2024
March 28, 2024
March 28, 2024
March 28, 2024
March 28, 2024
March 28, 2024
Index to Consolidated Financial Statements
Financial Statements:
Report of Independent Registered Public Accounting Firm (PCAOB ID 173)
Report of Independent Registered Public Accounting Firm (PCAOB ID 199)
Consolidated Balance Sheets as of December 31, 2023 and 2022
Consolidated Statements of Operations for the Years Ended December 31, 2023 and 2022
Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2023 and 2022
Consolidated Statements of Cash Flows for the Years Ended December 31, 2023 and 2022
Notes to Consolidated Financial Statements
F-1
Page
F-2
F-3
F-4
F-5
F-6
F-7
F-8
Report of Independent Registered Public Accounting Firm
Shareholders and the Board of Directors of Dyadic International, Inc.
Jupiter, Florida
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheet of Dyadic International, Inc. (the "Company") as of December 31, 2023, the related consolidated statements of
operations, stockholders’ equity, and cash flows for the year ended December 31, 2023, 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, 2023, and the results of its operations and its cash flows for
the year ended December 31, 2023, 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 audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about
whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of
its internal control over financial reporting. As part of our audit 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 audit 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 audit 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 audit provide a reasonable basis for our opinion.
Critical Audit Matters
Critical audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee
and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. We
determined that there are no critical audit matters.
/s/Crowe LLP
We have served as the Company's auditor since 2023.
Livingston, New Jersey
March 28, 2024
F-2
Report of Independent Registered Public Accounting Firm
To the Board of Directors and
Stockholders of Dyadic International, Inc.:
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheet of Dyadic International, Inc. and Subsidiaries ("Company”) as of December 31, 2022, and the related consolidated
statements of operations, stockholders’ equity, and cash flows for the year ended December 31, 2022, 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, 2022, and the results of its operations and
its cash flows for the year ended December 31, 2022, 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 audit to obtain reasonable assurance about
whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of
its internal control over financial reporting. As part of our audit, 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 audit 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 audit 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 audit provides a reasonable basis for our opinion.
/s/Mayer Hoffman McCann P.C.
We have served as the Company’s auditor from 2008 through 2023.
St. Petersburg, Florida
March 28, 2024
F-3
DYADIC INTERNATIONAL, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
$
$
$
December 31,
2023
2022
6,515,028 $
748,290
10,083
466,159
327,775
8,067,335
141,439
—
10,462
8,219,236 $
656,445 $
1,057,164
490,113
—
48,059
2,251,781
—
88,870
2,340,651
5,794,272
6,847,270
58,285
330,001
392,236
13,422,064
—
284,709
6,045
13,712,818
1,276,313
955,081
40,743
176,471
—
2,448,608
176,471
—
2,625,079
Assets
Current assets:
Cash and cash equivalents
Short-term investment securities
Interest receivable
Accounts receivable
Prepaid expenses and other current assets
Total current assets
Non-current assets:
Operating lease right-of-use asset, net
Investment in Alphazyme
Other assets
Total assets
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable
Accrued expenses
Deferred research and development obligations
Deferred license revenue, current portion
Operating lease liability, current portion
Total current liabilities
Deferred license revenue, net of current portion
Operating lease liability, net of current portion
Total liabilities
Commitments and contingencies (Note 5)
Stockholders’ equity:
Preferred stock, $.0001 par value:
Authorized shares - 5,000,000; none issued and outstanding
Common stock, $.001 par value:
Authorized shares - 100,000,000; issued shares - 41,064,563 and 40,816,602, outstanding shares - 28,811,061 and 28,563,100
as of December 31, 2023 and 2022, respectively
Additional paid-in capital
Treasury stock, shares held at cost - 12,253,502
Accumulated deficit
Total stockholders’ equity
Total liabilities and stockholders’ equity
$
—
—
41,065
105,044,756
(18,929,915)
(80,277,321)
5,878,585
8,219,236 $
40,817
103,458,697
(18,929,915)
(73,481,860)
11,087,739
13,712,818
The accompanying notes are an integral part of these audited consolidated financial statements.
F-4
DYADIC INTERNATIONAL, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
Revenues:
Research and development revenue
License revenue
Total revenue
Costs and expenses:
Costs of research and development revenue
Research and development
General and administrative
Foreign currency exchange loss
Total costs and expenses
Loss from operations
Other income:
Interest income
Gain on sale of Alphazyme
Other income
Total other income
Net loss
Basic and diluted net loss per common share
Basic and diluted weighted-average common shares outstanding
$
$
$
Years Ended December 31,
2023
2022
2,545,865 $
352,941
2,898,806
1,975,849
3,297,266
5,817,013
38,417
11,128,545
2,683,244
247,059
2,930,303
2,123,193
4,501,365
6,421,505
49,918
13,095,981
(8,229,739)
(10,165,678)
416,686
1,017,592
—
1,434,278
180,420
—
250,000
430,420
(6,795,461) $
(9,735,258)
(0.24) $
(0.34)
28,798,833
28,364,482
The accompanying notes are an integral part of these audited consolidated financial statements.
F-5
DYADIC INTERNATIONAL, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
Common Stock
Treasury Stock
Shares
Amount
Shares
Amount
Additional
paid-in capital
Accumulated
deficit
Total
Balance at December 31, 2021
40,482,659 $
40,483
(12,253,502) $ (18,929,915) $ 101,026,496 $ (63,746,602) $
18,390,462
Stock-based compensation expenses
—
—
—
—
1,888,944
—
1,888,944
Issuance of common stock upon exercise of stock
options
Net loss
333,943
—
334
—
—
—
—
543,257
—
543,591
—
—
(9,735,258)
(9,735,258)
Balance at December 31, 2022
40,816,602 $
40,817
(12,253,502) $ (18,929,915) $ 103,458,697 $ (73,481,860) $
11,087,739
Stock-based compensation expenses
—
—
—
—
1,244,121
—
1,244,121
Issuance of common stock upon vesting of restricted
stock units
Net loss
247,961
—
248
—
—
—
—
341,938
—
342,186
—
—
(6,795,461)
(6,795,461)
Balance at December 31, 2023
41,064,563 $
41,065
(12,253,502) $ (18,929,915) $ 105,044,756 $ (80,277,321) $
5,878,585
The accompanying notes are an integral part of these audited consolidated financial statements.
F-6
DYADIC INTERNATIONAL, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
Cash flows from operating activities
Net loss
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense
Amortization of held-to-maturity securities, net
Gain on investment in Alphazyme
Foreign currency exchange loss
Changes in operating assets and liabilities:
Operating lease assets and liabilities, net
Interest receivable
Accounts receivable
Prepaid expenses and other current assets
Accounts payable
Accrued expenses
Deferred license revenue
Deferred research and development obligations
Net cash used in operating activities
Cash flows from investing activities
Purchases of held-to-maturity investment securities
Proceeds from maturities of investment securities
Proceeds from the sale of investment in Alphazyme
Net cash provided by (used in) investing activities
Cash flows from financing activities
Proceeds from exercise of options
Net cash provided by financing activities
Effect of exchange rate changes on cash
Net decrease in cash and cash equivalents
Cash and cash equivalents at beginning of period
Cash and cash equivalents at end of period
Supplemental cash flow information
Vesting of restricted stock units
Right-of-use asset obtained in exchange for lease obligations
Years Ended December 31,
2023
2022
$
(6,795,461) $
(9,735,258)
1,244,121
(53,032)
(1,017,592)
38,418
(4,510)
48,202
(141,332)
64,902
(651,168)
444,269
(352,942)
449,370
(6,726,755)
(2,995,988)
9,148,000
1,297,884
7,449,896
—
—
(2,385)
720,756
5,794,272
6,515,028 $
342,186 $
156,983 $
1,888,944
33,790
—
49,918
—
36,090
(83,265)
(13,925)
(248,128)
245,521
(147,058)
(110,404)
(8,083,775)
(9,869,280)
7,500,000
—
(2,369,280)
543,591
543,591
(44,744)
(9,954,208)
15,748,480
5,794,272
—
—
$
$
$
The accompanying notes are an integral part of these audited consolidated financial statements.
F-7
Notes to Consolidated Financial Statements
Note 1: Organization and Summary of Significant Accounting Policies
Description of Business
Dyadic International, Inc. ("Dyadic”, "we”, "us”, "our”, or the "Company”) is a global biotechnology company based in Jupiter, Florida with operations in the United
States and a satellite office in the Netherlands, and it utilizes third-party consultants and research organizations to carry out the Company’s activities. Over the past two plus
decades, the Company has developed a gene expression platform for producing commercial quantities of industrial enzymes and other proteins, and has previously licensed this
technology to third parties, such as Abengoa BioenergySA, BASF SE, Codexis, Inc. and others, for use in industrial (non-pharmaceutical) applications. This technology is based
on the Thermothelomyces heterothallica (formerly known as Myceliophthora thermophila) fungus, which the Company named C1.
Subsequent to the Company selling its industrial technology business to Danisco USA ("Danisco”), the industrial biosciences business of DuPont (NYSE: DD) (the
"DuPont Transaction”) on December 31, 2015, the Company has been focused on building the C1-cell protein production platform for the development and production of biologic
products including enzymes and other proteins for human and animal health. Some examples of human and animal vaccines and drugs which have the potential to be produced
from C1-cells are protein antigens, ferritin nanoparticles, virus-like particles ("VLPs”), monoclonal antibodies ("mAbs”), Bi/Tri-specific antibodies, Fab antibody fragments, Fc-
fusion proteins, as well as other therapeutic enzymes and proteins. The Company is involved in multiple funded research collaborations with animal and human pharmaceutical
companies which are designed to leverage its C1-cell protein production platform to develop innovative vaccines and drugs, biosimilars and/or biobetters.
The Company also developed the Dapibus™ thermophilic filamentous fungal based microbial protein production platform to enable the rapid development and large-scale
manufacture of low-cost proteins, metabolites, and other biologic products for use in non-pharmaceutical applications, such as food, nutrition, and wellness.
Liquidity and Capital Resources
The Company expects to incur losses and have negative net cash flows from operating activities as it continues developing its microbial platforms and related products,
and as it expands its pipelines and engages in further research and development activities for internal products as well as for its third-party collaborators and licensees. The
success of the Company depends on its ability to develop its technologies and products to the point of regulatory approval and subsequent revenue generation or through the
sublicensing of the Company’s technologies and products, to raise capital to finance these developmental efforts.
For the year ended December 31, 2023, the Company received $1.3 million from the sale of its equity interest in Alphazyme, LLC, and $600,000 upfront payment from a
product development and licensing agreement.
On March 8, 2024, the Company sold and issued an aggregate principal amount of $6.0 million of its 8.0% Senior Secured Convertible Promissory Notes due March 8, 2027
(the "Convertible Notes”) in a private placement in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities
Act”). The purchasers of the Convertible Notes include immediate family members and family trusts related to Mark Emalfarb, our President and Chief Executive Officer and a
member of our Board of Directors, including The Francisco Trust, an existing holder of more than 5% of the Company’s outstanding common stock, (collectively, the
"Purchasers”).
The Convertible Notes will be senior, secured obligations of Dyadic and its affiliates, and interest will be payable quarterly in cash on the principal amount equal to 8% per
annum. The Convertible Notes will mature on March 8, 2027 (the "Maturity Date”), unless earlier converted, repurchased, or redeemed in accordance with the terms of the
Convertible Notes.
The Convertible Notes can be converted into shares of Dyadic’s Class A common stock (the "Common Stock”), at the option of the holders of the Convertible Notes (the
"Noteholders”) at any time prior to the Maturity Date. The conversion price is $1.79 per share of the Common Stock, which is equal to 125% of the trailing 30-day VWAP of the
Common Stock ending on the trading day immediately preceding the date of the securities purchase agreement.
This private placement funding strengthened our financial position, and it will support our new-term revenue growth and accelerate our strategic objective of
commercialization opportunities for pharmaceutical and non-pharmaceutical applications. The Company has received successful top-line results for the Phase 1 clinical trial of
DYAI-100, and we do not plan to continue Phase 2/3 clinical trials unless third-party funding is secured.
The Company expects its existing cash and cash equivalents and cash raised from the Convertible Notes, investments in debt securities, and operating cash flows will be
sufficient to meet its operational, business, and other liquidity requirements for at least the next twelve ( 12) months from the date of issuance of the financial statements contained
in this Form 10-K. However, the Company has based this estimate on assumptions that may prove to be wrong, and its operating plan may change as a result of many factors
currently unknown to it. In the event our financing needs are not able to be met by our existing cash, cash equivalents and investments, we would seek to raise additional capital
through strategic financial opportunities that could include, but are not limited to, future public or private equity offerings, collaboration agreements, and/or other means. Any
amounts raised may be used for the further development and commercialization of product candidates, and for other working capital purposes. There is no guarantee that any of
these strategic or financing opportunities will be executed or realized on favorable terms, if at all, and some could be dilutive to existing shareholders.
Basis of Presentation
The accompanying audited consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. Dyadic consolidates entities in
which we have a controlling financial interest. We consolidate subsidiaries in which we hold and/or control, directly or indirectly, more than 50% of the voting rights. All
significant intra-entity transactions and balances have been eliminated in consolidation. These consolidated financial statements have been prepared in conformity with U.S.
generally accepted accounting principles ("GAAP”).
The Company conducts business in one operating segment, which is identified by the Company based on how resources are allocated, and operating decisions are made.
Management evaluates performance and allocates resources based on the Company as a whole.
F- 8
Use of Estimates
The preparation of these consolidated financial statements in accordance with GAAP requires management to make estimates and judgments that affect the reported
amount of assets and liabilities and related disclosure of contingent assets and liabilities at the date of our consolidated financial statements and the reported amounts of revenues
and expenses during the applicable period. Estimates inherent in the preparation of these consolidated financial statements include, but are not limited to, estimates related to
revenue recognition, accrued expenses, stock-based compensation expense, and income taxes. The Company bases its estimates on historical experience and other market specific
or other relevant assumptions it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates as there are changes in
circumstances, facts and experience. Actual results ma y differ from these estimates under different assumptions or conditions. Such differences could be material to the
consolidated financial statements.
Concentrations and Credit Risk
The Company’s financial instruments that are potentially subject to concentrations of credit risk consist primarily of cash and cash equivalents, investment securities, and
accounts receivable. At times, the Company has cash, cash equivalents, and investment securities at financial institutions exceeding the Federal Depository Insurance Company
("FDIC”) and the Securities Investor Protection Corporation ("SIPC”) insured limit on domestic currency and the Netherlands FDIC counterpart for foreign currency. The Company
only deals with reputable financial institutions and has not experienced any losses in such accounts.
For the years ended December 31, 2023 and 2022, the Company’s revenue was generated from sixteen and fourteen customers, respectively. As of December 31, 2023 and
2022, the Company’s accounts receivable was from thirteen and six customers, respectively. Significant customers are those that account for greater than 10% of the Company’s
revenues. For the years ended December 31, 2023 and 2022, two and three significant customers accounted for approximately $1,150,000 or 45.2% and $1,811,000 or 67.5% of
research and development revenue, respectively. The loss of business from one or a combination of the Company’s customers could adversely affect its operations.
The Company conducts operations in the Netherlands through its foreign subsidiary and generates a portion of its revenues from customers that are located outside of
the United States. For the years ended December 31, 2023 and 2022, the Company had six customers outside of the United Sates (i.e. European and Asian customers) that
accounted for approximately $537,000 or 21.1% and $586,000 or 21.8% of total revenue, respectively. As of December 31, 2023 and 2022, the Company had six and four customers
outside of the United Sates (i.e. European and Asian customers) that accounted for approximately $213,000 or 45.6% and $91,000 or 27.4% of accounts receivable, respectively.
The Company uses contract research organizations ("CROs”) to conduct its research projects and manage its clinical trial. For each of the years ended December 31, 2023
and 2022, three CROs accounted for approximately $4,644,000 or 96.0% and $5,575,000 or 97.9% of total research services we purchased, respectively. As of December 31, 2023,
three CROs accounted for approximately $620,000 or 94.4% of accounts payable. As of December 31, 2022, three CROs accounted for approximately $1,018,000 or 79.7% of
accounts payable. The loss of business from any CRO or a combination of the Company’s CROs could adversely affect its operations.
Cash and Cash Equivalents
We treat highly liquid investments with original maturities of three months or less when purchased as cash equivalents, including money market funds, which are
unrestricted for withdrawal or use.
Investment Securities
The Company’s investment policy requires investment securities to be investment grade and held to maturity with the primary objective to maintain a high degree of
liquidity while maximizing yield. The Company invests excess cash balances in short-term and long-term investment grade securities. Short-term investment securities mature within
twelve (12) months or less, and long-term investment securities mature over twelve (12) months from the applicable reporting date. Management determines the appropriate
classification of each investment at the time of purchase and reevaluates the classifications at each balance sheet date.
The Company classifies its investments in debt securities as held-to-maturity. Held-to-maturity securities are those securities that the Company has the ability and intent
to hold until maturity. Held-to-maturity securities are recorded at amortized cost, net of allowance for credit losses if applicable, and adjusted for the amortization or accretion of
premiums or discounts. Premiums and discounts are amortized over the life of the related held-to-maturity security. When a debt security is purchased at a premium, both the face
value of the debt and premium amount are reflected as investing outflow.
When evaluating an investment for other-than-temporary impairment, the Company reviews factors such as the length of time and extent to which fair value has been
below its cost basis, the financial condition of the issuer and any changes thereto, changes in market interest rates, and whether it is more likely than not the Company will be
required to sell the investment before recovery of the investment’s cost basis. The Company measures expected credit losses on held to maturity debt securities on an individual
security basis. The estimate of expected credit losses considers historical credit information from external sources. The impairment of the investment that is related to the credit
loss, if any, is expensed in the period in which the event or change occurred.
As of December 31, 2023 and 2022, all of our money market funds were invested in U.S. Government money market funds. The Company did not have any investment
securities classified as trading as of December 31, 2023 and 2022.
Accounts Receivable
Accounts receivable consist of billed receivables currently due from customers and unbilled receivables. Unbilled receivables represent the excess of contract revenue (or
amounts reimbursable under contracts) over billings to date. Such amounts become billable in accordance with the contract terms, which usually consider the passage of time,
achievement of certain milestones or completion of the project.
F- 9
Accounts receivable are stated net of an allowance for credit losses, if deemed necessary based on the Company’s evaluation of collectability and potential credit losses.
Management assesses the collectability of its accounts receivable using the specific identification of account balances and considers the credit quality and financial condition of
its significant customers, historical information regarding credit losses and the Company’s evaluation of current and expected future economic conditions and changes in our
customer collection trends. If necessary, an allowance for credit losses is recorded against accounts receivable such that the carrying value of accounts receivable reflects the net
amount expected to be collected. Accounts receivable balances are written off against the allowance for credit losses when the potential for collectability is considered remote.
Substantially all of our accounts receivable were current and include unbilled amounts that will be billed and collected over the next twelve (12) months. Management determined
that no allowance for credit losses was required as of December 31, 2023 and 2022.
Accounts receivable consist of the following:
Billed receivable
Unbilled receivable
Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consist of the following:
Prepaid insurance
Prepaid expenses - various
Prepaid taxes
Accounts Payable
Accounts payable consist of the following:
Research and development expenses
Legal expenses
Other
Accrued Expenses
Accrued expenses consist of the following:
Employee wages and benefits
Research and development expenses
Legal expenses
Other
Revenue Recognition
December 31,
2023
2022
410,617 $
55,542
466,159 $
115,469
214,532
330,001
December 31,
2023
2022
209,888 $
117,887
—
327,775 $
265,429
124,273
2,534
392,236
December 31,
2023
2022
575,436 $
1,957
79,052
656,445 $
1,067,958
56,514
151,841
1,276,313
December 31,
2023
2022
561,720 $
274,080
210,004
11,360
1,057,164 $
580,264
343,457
—
31,360
955,081
$
$
$
$
$
$
$
$
The Company has no products approved for sale. All our revenue to date has been research revenue from third-party collaborations and government grants, as well as
revenue from sublicensing agreements and collaborative arrangements, which may include upfront payments, options to obtain a license, payment for research and development
services, milestone payments and royalties, in the form of cash or non-cash considerations (e.g., minority equity interest).
F- 10
Revenue related to research collaborations and agreements: The Company typically performs research and development services as specified in each respective
agreement on a best-efforts basis, and recognizes revenue from research funding under collaboration agreements in accordance with the 5-step process outlined in ASC Topic 606
("Topic 606”): (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction
price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. We recognize revenue when we satisfy a
performance obligation by transferring control of the service to a customer in an amount that reflects the consideration that we expect to receive. Depending on how the
performance obligation under our license and collaboration agreements is satisfied, we recognize the revenue either at a point in time or over time by using the input method under
Topic 606 to measure the progress toward complete satisfaction of a performance obligation.
Under the input method, revenue will be recognized based on the entity’s efforts or inputs to the satisfaction of a performance obligation (e.g., resources consumed, labor
hours expended, costs incurred, or time elapsed) relative to the total expected inputs to the satisfaction of that performance obligation. The Company believes that the cost-based
input method is the best measure of progress to reflect how the Company transfers its performance obligation to a customer. In applying the cost-based input method of revenue
recognition, the Company uses actual costs incurred relative to budgeted costs to fulfill the performance obligation. These costs consist primarily of full-time equivalent effort and
third-party contract costs. Revenue will be recognized based on actual costs incurred as a percentage of total budgeted costs as the Company completes its performance
obligations.
A cost-based input method of revenue recognition requires management to make estimates of costs to complete the Company’s performance obligations. In making such
estimates, significant judgment is required to evaluate assumptions related to cost estimates. The cumulative effect of revisions to estimated costs to complete the Company’s
performance obligations will be recorded in the period in which changes are identified and amounts can be reasonably estimated. A significant change in these assumptions and
estimates could have a material impact on the timing and amount of revenue recognized in future periods.
Revenue related to grants: The Company may receive grants from governments, agencies, and other private and not-for-profit organizations. These grants are intended to
be used to partially or fully fund the Company’s research collaborations . However, most, if not all, of such potential grant revenues, if received, is expected to be earmarked for
third parties to advance the research required, including preclinical and clinical trials for SARS-CoV-2 vaccines and/or antibodies candidates.
Revenue related to sublicensing agreements: If the sublicense to the Company’s intellectual property is determined to be distinct from the other performance obligations
identified in the arrangement, the Company recognizes revenue allocated to the license when technology is transferred to the customer and the customer can use and benefit from
the license.
Customer options: If the sublicensing agreement includes customer options to purchase additional goods or services, the Company will evaluate if such options are
considered material rights to be deemed as separate performance obligations at the inception of each arrangement.
Milestone payments: At the inception of each arrangement that includes development, commercialization, and regulatory milestone payments, the Company evaluates
whether the achievement of the milestones is considered probable and estimates the amount to be included in the transaction price. If the milestone payment is in exchange for a
sublicense and is based on the sublicensee’s subsequent sale of product, the Company recognizes milestone payment by applying the accounting guidance for royalties. To date,
the Company has not recognized any milestone payment revenue resulting from any of its sublicensing arrangements.
Royalties: With respect to licenses deemed to be the predominant item to which the sales-based royalties relate, including milestone payments based on the level of sales,
the Company recognizes revenue at the later of (i) when the related sales occur or (ii) when the performance obligation to which some or all the royalty has been allocated has been
satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from any of its sublicensing arrangements.
We invoice customers based on our contractual arrangements with each customer, which may not be consistent with the period that revenues are recognized. When there
is a timing difference between when we invoice customers and when revenues are recognized, we record either a contract asset (unbilled accounts receivable) or a contract liability
(deferred research and development obligations), as appropriate. If upfront fees or considerations related to sublicensing agreement are received prior to the technology transfer,
the Company will record the amount received as deferred revenue from licensing agreement.
We are not required to disclose the value of unsatisfied performance obligations for (i) contracts with an original expected length of one year or less and (ii) contracts for
which we recognize revenue at the amount to which we have the right to invoice for services performed.
The Company adopted a practical expedient to expense sales commissions when incurred because the amortization period would be one year or less.
F- 11
Leases
The Company determines if an arrangement is, or contains, a lease at contract inception and during modifications or renewal of existing leases. The Company
does not recognize leases with terms of twelve months or less on the balance sheet. Options to extend or terminate a lease are not included in the Company’s initial lease term
assessment, unless there is reasonable certainty that the Company will exercise any such option. Leases are classified as either finance leases or operating leases based on criteria
in Accounting Standards Codification ("ASC”) 842.
For operating leases, right-of-use assets and liabilities are recognized at lease commencement date based on the present value of lease payments over the lease term. In
determining the net present value of lease payments, the Company uses an estimated rate of interest that they would have to pay to borrow equivalent funds on a collateralized
basis at the lease commencement date. The operating lease right-of-use asset also includes any lease payments made and excludes any lease incentives. Lease expense is
recognized on a straight-line basis over the expected lease term.
The Company’s prior lease for its corporate headquarters located at 140 Intracoastal Pointe Dr. expired on August 31, 2023, and there was no right-of-use asset or lease
liability recognized for this lease due to its short-term nature. In August 2023, the Company entered into a new lease ("1044 N Lease”) comprising approximately 1,719 square feet
of office space located at 1044 N US 1, Jupiter, Florida, commencing September 1, 2023 ("Commencement Date”) and will expire on August 31, 2026. Rent is subject to three percent
(3%) annual increases, and the Company is responsible for certain common area maintenance charges and taxes throughout the life of the 1044 N Lease. The 1044 N Lease has an
initial term of three (3) years, following the Commencement Date with an option to extend for two (2) successive one (1) year terms. The options were not included in the lease term
used in determining the right-of-use asset or lease liability as the Company did not consider it reasonably certain they would exercise the options.
For the years ended December 31, 2023 and 2022, the Company’s total operating lease expense was approximately $72,000 and $58,000, respectively. As of December 31,
2023, the Company’s total operating lease liabilities was approximately $136,929, which is presented net of imputed interest of $16,770, and the operating lease right-of-use asset
was approximately $141,439. There were no operating lease liabilities or operating lease right-of-use assets as of December 31, 2022.
As of December 31, 2023, the weighted average remaining lease term was 2.7 years, and the weighted average discount rate was 8.8%.
Research and Development Costs
Research and development ("R&D”) costs are expensed as incurred. R&D costs are related to the Company’s internally funded pharmaceutical programs and other
governmental and commercial projects.
Research and development costs consist of personnel-related costs, facilities, research-related overhead, services from independent contract research organizations, and
other external costs. Research and development costs, during the years ended December 31, 2023 and 2022 were as follows:
Outside contracted services
Personnel related costs
Facilities, overhead and other
Foreign Currency Transaction Gain or Loss
Years Ended December 31,
2023
2022
$
$
2,677,941 $
553,741
65,584
3,297,266 $
3,707,269
743,051
51,045
4,501,365
The Company and its foreign subsidiary use the U.S. dollar as its functional currency, and initially measure the foreign currency denominated assets and liabilities at the
transaction date. Monetary assets and liabilities are then re-measured at exchange rates in effect at the end of each period, and property and non-monetary assets and liabilities are
converted at historical rates.
Fair Value Measurements
The Company applies fair value accounting for certain financial instruments that are recognized or disclosed at fair value in the financial statements. The Company defines
fair value as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair
value is estimated by applying the following hierarchy, which prioritizes the inputs used to measure fair value into three levels and bases the categorization within the hierarchy
upon the lowest level of input that is available and significant to the fair value measurement:
•
•
•
Level 1 – Quoted prices in active markets for identical assets or liabilities.
Level 2 – Observable inputs other than quoted prices in active markets for identical assets and liabilities, quoted prices for identical or similar assets or liabilities in
inactive markets, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3 – Inputs that are generally unobservable and typically reflect management’s estimate of assumptions that market participants would use in pricing the asset or
liability.
The Company’s financial instruments included cash and cash equivalents, investment in debt securities, accounts receivable, accounts payable and accrued expenses,
accrued payroll and related liabilities, deferred research and development obligations and deposits. The carrying amount of these financial instruments, except for investment in
debt securities, approximates fair value due to the short-term maturities of these instruments. The Company’s short-term and long-term investments in debt securities are recorded
at amortized cost, and their estimated fair value amounts are provided by the third-party broker service for disclosure purposes.
F- 12
Income Taxes
The Company accounts for income taxes under the asset and liability method in accordance with ASC Topic 740, "Income Taxes”. Under this method, income tax expense
/(benefit) is recognized for: (i) taxes payable or refundable for the current year and (ii) deferred tax consequences of temporary differences resulting from matters that have been
recognized in an entity’s financial statements or tax returns. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years
in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the results of
operations in the period that includes the enactment date. A valuation allowance is provided to reduce the deferred tax assets reported if based on the weight of the available
positive and negative evidence, it is more likely than not some portion or all the deferred tax assets will not be realized.
In determining taxable income for the Company’s consolidated financial statements, we are required to estimate income taxes in each of the jurisdictions in which we
operate. This process requires the Company to make certain estimates of our actual current tax exposure and assessment of temporary differences between the tax and financial
statement recognition of revenue and expense. In evaluating the Company’s ability to recover its deferred tax assets, the Company must consider all available positive and
negative evidence including its past operating results, the existence of cumulative losses in the most recent years and its forecast of future taxable income. Significant management
judgment is required in determining our provision for income taxes, deferred tax assets and liabilities and any valuation allowance recorded against our net deferred tax assets.
The Company is required to evaluate the provisions of ASC 740 related to the accounting for uncertainty in income taxes recognized in a company’s financial statements.
ASC 740 prescribes a comprehensive model for how a company should recognize, present, and disclose uncertain positions that the company has taken or expects to take in its tax
return. For those benefits to be recognized, a tax position must be more-likely-than-not to be sustained upon examination by taxing authorities. Differences between tax positions
taken or expected to be taken in a tax return and the net benefit recognized and measured pursuant to the interpretation are referred to as "unrecognized benefits.” A liability
should be recognized (or amount of net operating loss carry forward or amount of tax refundable is reduced) for unrecognized tax benefits, because it represents a company’s
potential future obligation to the taxing authority for a tax position that was not recognized as a result of applying the provision of ASC 740.
Other Income
For the year ended December 31, 2023, other income of approximately $1,018,000 was related to the sale of the equity interest in Alphazyme, LLC. For the year ended
December 31, 2022, other income of $250,000 was related to a settlement payment we received from the termination of term sheet of a proposed license and collaboration.
Comprehensive Income (Loss)
Comprehensive income (loss) includes net income (loss) and other revenue, expenses, gains and losses that are recorded as an element of shareholders’ equity but are
excluded from net income (loss) under U.S. GAAP. The Company does not have any significant transactions that are required to be reported in other comprehensive income (loss),
and therefore, does not separately present a statement of comprehensive income (loss) in its consolidated financial statements.
Stock-Based Compensation
We recognize all share-based payments to employees, consultants, and our Board of Directors (the "Board”), as non-cash compensation expense, in research and
development expenses or general and administrative expenses in the consolidated statement of operations based on the grant date fair values of such payments. Stock-based
compensation expense recognized each period is based on the value of the portion of share-based payment awards that is ultimately expected to vest during the period. Forfeitures
are recorded as they occur.
For performance-based awards, the Company recognizes related stock-based compensation expense based upon its determination of the potential likelihood of
achievement of the specified performance conditions at each reporting date.
Net Loss Per Share
Basic net loss per share is computed by dividing net loss available to common shareholders by the weighted average number of common shares outstanding during the
reporting period. Diluted net loss per share adjusts the weighted average number of common stock outstanding for the potential dilution that could occur if common stock
equivalents, such as stock options, warrants, restricted stock, restricted stock units and convertible debt, were exercised and converted into common stock, calculated by applying
the treasury stock method.
For the years ended December 31, 2023 and 2022, the effect of the potential exercise of options to purchase 5,469,247 and 5,031,097 shares of common stock, respectively,
were excluded from the computation of diluted net loss per share as their effect would have been anti-dilutive.
Recently Adopted Accounting Pronouncements
In June 2016, the Financial Accounting Standards Board (the "FASB”) issued Accounting Standards Update (the "ASU”) 2016-13, Financial Instruments—Credit
Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. which replaces the incurred loss model with a forward-looking expected credit loss ("CECL”) model
and requires consideration of a broader range of reasonable and supportable information to estimate expected credit losses. ASU 2016-13 applies to financial assets, measured at
amortized cost, including held-to-maturity debt securities and accounts receivable. ASU 2016-13 must be adopted using a modified retrospective transition method through a
cumulative-effect adjustment to members’ equity in the period of adoption. The Company adopted ASU 2016-13 and related amendments as of January 1, 2023, and the adoption of
the new standard did not have a material impact on the Company’s consolidated financial statements.
F- 13
Recent Accounting Pronouncements Not Adopted as of December 31, 2023
In December 2023, the FASB issued Accounting Standards Update 2023-09 – Income Taxes (Topic ASC 740) Income Taxes. The ASU improves the transparency of
income tax disclosures by requiring (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) income taxes paid disaggregated by
jurisdiction. It also includes certain other amendments to improve the effectiveness of income tax disclosures. The amendments in ASU 2023-09 will become effective beginning
with our 2025 fiscal year. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. We do not expect that this
guidance will have a material impact on our financial position and results of operations.
In November 2023, the FASB issued Accounting Standards Update 2023-07 – Segment Reporting (Topic ASC 280) Improvements to Reportable Segment Disclosures. The
ASU improves reportable segment disclosure requirements, primarily through enhanced disclosure about significant segment expenses. The enhancements under this update
require disclosure of significant segment expenses that are regularly provided to the Chief Operating Decision Maker ("CODM”) and included within each reported measure of
segment profit or loss, require disclosure of other segment items by reportable segment and a description of the composition of other segment items, require annual disclosures
under ASC 280 to be provided in interim periods, clarify use of more than one measure of segment profit or loss by the CODM, require that the title of the CODM be disclosed with
an explanation of how the CODM uses the reported measures of segment profit or loss to make decisions, and require that entities with a single reportable segment provide all
disclosures required by this update and required under ASC 280. ASU 2023-07 is effective for public business entities for fiscal years beginning after December 15, 2023, with early
adoption permitted. We continue to evaluate these changes and do not expect that this guidance will have a material impact on our financial position, results of operations, or
financial statement disclosures.
Note 2: Cash, Cash Equivalent, and Investments
The Company’s investments in debt securities are classified as held-to-maturity and are recorded at amortized cost, net of allowance for credit losses, and its investments
in money market funds are classified as available-for-sale securities and presented as cash equivalents on the consolidated balance sheets. The following table shows the
Company’s cash, available-for-sale securities, and investment securities by major security type as of December 31, 2023 and 2022:
Cash and Cash Equivalents
Cash
Money Market Funds
Subtotal
Short-Term Investment Securities (2)
Corporate Bonds (3)
Total
Cash and Cash Equivalents
Cash
Money Market Funds
Subtotal
Short-Term Investment Securities (2)
Corporate Bonds (3)
Total
Level
(1)
1
2
Level
(1)
1
2
December 31, 2023
Gross
Unrealized
Holding Gains
Gross
Unrealized
Fair Value
Holding Losses Adjusted Cost
$
$
25,775 $
6,489,253
6,515,028
748,105
7,263,133 $
— $
—
—
—
— $
— $
—
—
(185)
(185) $
25,775
6,489,253
6,515,028
748,290
7,263,318
December 31, 2022
Gross
Unrealized
Holding Gains
Gross
Unrealized
Fair Value
Holding Losses Adjusted Cost
$
$
26,782 $
5,767,490
5,794,272
6,800,062
12,594,334 $
— $
—
—
—
— $
— $
—
—
(47,208)
(47,208) $
26,782
5,767,490
5,794,272
6,847,270
12,641,542
Notes:
(1) Definition of the three-level fair value hierarchy:
• Level 1 - Quoted prices (unadjusted) in active markets for identical assets or liabilities
• Level 2 - Other inputs that are directly or indirectly observable in the markets
• Level 3 - Inputs that are generally unobservable
(2) Short-term investment securities will mature within 12 months or less, from the applicable reporting date.
(3) For the years ended December 31, 2023 and 2022, the Company received discounts of $39,012 and $6,280 to purchase held-to-maturity investment securities, respectively.
The Company considers declines in market value of its investment portfolio to be temporary in nature. The Company’s investment policy requires investment securities to
be investment grade and held to maturity with the primary objective to maintain a high degree of liquidity while maximizing yield. When evaluating an investment for other-than-
temporary impairment, the Company reviews factors such as the length of time and extent to which fair value has been below its cost basis, the financial condition of the issuer and
any changes thereto, changes in market interest rates, and whether it is more likely than not the Company will be required to sell the investment before recovery of the investment’s
cost basis. As of December 31, 2023, the Company does not consider any of its investments to be other-than-temporarily impaired.
F- 14
Note 3: Research and Collaboration Agreements, Sublicense Agreements, and Investments in Privately Held Companies
Inzymes ApS
O n September 18, 2023, Dyadic International (USA) Inc., a subsidiary of the Company, signed a Development and Exclusive License Agreement (the "Inzymes
Agreement”) with Inzymes ApS ("Inzymes”), a Denmark corporation, to develop and commercialize certain non-animal dairy enzymes used in the production of food products
using Dyadic’s proprietary Dapibus™ platform.
Under the terms of the Inzymes Agreement, a research collaboration to develop a basket of dairy enzymes will be fully funded by Inzymes with an upfront payment of $0.6
million and an additional payment payable upon the first commercial sale of product. Dyadic will also be eligible to receive success fees upon the achievement of certain target
yields, milestone payments upon the first commercial sale of each product and royalties.
In October 2023, the Company received the upfront payment of $0.6 million in accordance with the terms of the Inzymes Agreement. The payment consisted of funding
for specified product research and development efforts and right of first refusal for certain product candidates. For the year ended December 31, 2023, the Company recorded
research and development revenues of approximately $110,000, in connection with the Inzymes Agreement.
A Global Food Ingredient Company
On May 10, 2022, the Company entered into a Joint Development Agreement (the "JDA”) with a Global Food Ingredient Company ("GFIC”) to develop and manufacture
several animal free ingredient products using the Company’s biotechnologies.
Under the initial terms of the JDA, Dyadic was to develop its proprietary production cell lines for the manufacture of animal free ingredient product candidates. As of
December 31, 2023, the GFIC has completed its one-year funding commitment for the initial phase of research collaboration in an amount approximating $1.35 million, and, pursuant
to the GFIC’s rights under the JDA, the Company and the GFIC are conferring to decide whether or not, and if it is possible, to move forward to the next phase of the project. The
Company is also considering other funding sources to continue the project.
For the years ended December 31, 2023 and 2022, the Company recorded research and development revenues, including milestone payments, of approximately $631,000
and $790,000, respectively, in connection with the JDA.
Phibro/Abic
On February 10, 2022, the Company entered into an exclusive sub-license agreement with Abic Biological Laboratories Ltd. ("Abic”), an affiliate of Phibro Animal Health
Corporation ("Phibro”) to provide services for a targeted disease (the "Phibro/Abic Agreement”). The Phibro/Abic Agreement was an addendum to the initially non-exclusive sub-
license agreement the Company signed with Phibro on July 1, 2020. According to the Phibro/Abic Agreement, the Company received an exclusivity payment in April 2022. Since
then, the Company has expanded the license agreement to include additional research projects to develop animal vaccines for livestock.
Under the Phibro/Abic Agreement, the Company has received an exclusivity payment in April 2022 and is eligible to receive certain milestone payment upon regulatory
approval, and future sales-based royalty payments. The milestone payment is considered constrained variable consideration and excluded from the transaction price at inception.
The Company will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. The Company will not
recognize revenue related to sales-based royalty until the associated event occurs.
As of December 31, 2023, there were no events or circumstances that would change the transaction price and no milestone or royalty payments have been recognized.
Janssen
On December 16, 2021, the Company entered a Research, License, and Collaboration Agreement (the "Janssen Agreement”) for the manufacture of therapeutic protein
candidates using its C1-cell protein production platform with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson ("Janssen”).
On October 2, 2023, Janssen provided written notice to Dyadic that it has decided to wind down the collaboration with an effective end date of December 31, 2023.
For the years ended December 31, 2023 and 2022, the Company recognized approximately $353,000 and $176,000 license revenue and research and development revenues
of approximately $520,000 and $539,000, respectively, in connection with the Janssen Agreement. As of December 31, 2023 a n d 2022, approximately $145,000 and
$121,000 of accounts receivable were related to Janssen, respectively.
Alphazyme
In 2019 the Company entered into a sub-licensing agreement with Alphazyme, LLC ("Alphazyme”) that was subsequently amended (the "Amended Alphazyme LLC
Agreement”). Under the Amended Alphazyme LLC Agreement, Alphazyme obtained additional capital contribution and Dyadic’s ownership was diluted to 1.99%.
The Company evaluated the nature of its equity interest investment in Alphazyme and determined that Alphazyme is a VIE due to the capital structure of the entity.
However, the Company is not the primary beneficiary of Alphazyme as Dyadic does not have the power to control or direct the activities of Alphazyme that most significantly
impact the VIE. As a result, the Company does not consolidate its investment in Alphazyme. The Company reports its investment in Alphazyme under the cost method of
accounting, given that it does not have the ability to exercise significant influence or control over Alphazyme.
F- 15
On January 18, 2023, the Company entered into a Securities Purchase Agreement, under which the Company agreed to sell its equity interest in Alphazyme, LLC (the
"Alphazyme Sale Agreement”). The Company continues to have the potential to receive additional payments based on the future sales of Alphazyme’s existing products, pursuant
to the Alphazyme Sale Agreement.
The Amended Sublicense Agreement between Dyadic and Alphazyme, which was previously entered on June 24, 2020, remains in effect. Under the Amended Alphazyme
Sub-License Agreement, Dyadic is entitled to potential milestone and royalty payments upon the commercialization of Alphazyme products using Dyadic’s proprietary C1-cell
protein production platform.
For the year ended December 31, 2023, the Company received a total cash payment of approximately $1.3 million from the sale of its equity interest in Alphazyme, LLC.
Note 4: Income Taxes
For the year ended December 31, 2023, there was no provision for income taxes or unrecognized tax benefits recorded.
The significant components of gain (loss) before income taxes are as follows:
U.S. operations
Foreign operations
Total loss before provision for income taxes
Years Ended December 31,
2023
2022
$
$
(6,766,409) $
(29,052)
(6,795,461) $
(9,828,427)
93,169
(9,735,258)
The Company has no current or deferred income tax for the years ended December 31, 2023 and 2022.
The income tax provision differs from the expense amount that would result from applying the federal statutory rates to income before income taxes due to permanent
differences, state income taxes and a change in the deferred tax valuation allowance.
The reconciliation between the statutory tax rate and the Company’s actual effective tax rate is as follows:
Tax at U.S. statutory rate
State taxes, net of federal benefit
Non-deductible items
Change in valuation allowance
True-up adjustment
Foreign operations
Change in tax rate
Other
Effective income tax rate
The significant components of the Company’s net deferred income tax assets are as follows:
Section 174 - R&D expenses
Stock option expense
NOL carryforward
Research and development credits
Operating lease liability
Right-of-use asset
Other
Deferred tax asset, net of deferred tax liabilities
Valuation allowance
Net deferred tax asset
Years Ended December 31,
2023
2022
(21.00)%
(4.19)
0.76
14.54
10.00
(0.11)
—
—
—%
(21.00)%
(4.35)
—
24.77
0.34
0.24
—
—
—%
December 31,
2023
2022
$
$
1,769,000 $
1,419,300
11,620,700
1,503,600
34,700
(35,800)
134,800
16,446,300
(16,446,300)
— $
1,046,400
1,341,900
11,524,900
1,623,100
—
—
(78,200)
15,458,100
(15,458,100)
—
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the
amounts used for income tax purposes. In assessing the realizability of deferred tax assets, Management evaluates whether it is more likely than not that some portion or all of the
deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those
temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income and tax planning strategies in
making this assessment. Based on Management’s evaluation, the net deferred tax asset, was offset by a full valuation allowance as of December 31, 2023 and 2022.
F- 16
The Company had federal and state net operating loss ("NOL”) carryforwards available as of December 31, 2023, and 2022, in the amount of approximately $45.9 million
and $44.0 million, respectively. Approximately $42.9 million of the federal net operating loss carryforwards will be carried forward indefinitely and will be available to offset 80% of
taxable income. The remaining amount of the net operating loss carryforwards will expire at varying dates through 2037. In addition, the Company had foreign net operating loss
carryforwards available as of December 31, 2023, and 2022, in the amounts of approximately $1.4 million and $1.4 million. These foreign net operating loss carryforwards will begin
to expire, if unused, in various amounts between 2025 and 2027.
The Tax Cuts and Jobs Act eliminated the current year deduction election for research and experimental expenditures. Instead, a taxpayer must charge such expenditures
to a capital account and is allowed to amortize such expenditures ratably over a five-year period (or fifteen-year period for expenditures attributable to foreign research), beginning
with the midpoint of the tax year in which such expenditures are paid or incurred.
Note 5: Commitments and Contingencies
Leases
Jupiter Florida Headquarters
In August 2023, the Company entered into a new lease comprising approximately 1,719 square feet of office space located at 1044 N US 1, Jupiter, Florida, commencing
September 1, 2023, and will expire on August 31, 2026. The Company occupies this space for an annual rental rate of approximately $59,000.
The Netherlands Office
The Company maintains a small satellite office in Wageningen, The Netherlands. The Company occupies a flexible office space for an annual rental rate of approximately
$4,800. The lease expires on January 31, 2025, and thereafter, the Company will reconsider the leased space to align with the future operations of the Company.
As of December 31, 2023, the future minimum annual lease payments under the operating leases are below. There are no future minimum annual lease payments after 2026.
2024
2025
2026
Total
Purchase Obligations
$
$
53,361
59,901
35,638
148,900
Purchase obligations are primarily related to our contracts with the Company’s contract research organizations to provide certain research services. The contracts set
forth the Company’s minimum purchase requirements that are subject to adjustments based on certain performance conditions. The commitments related to agreements to
purchase certain services in the ordinary course of business, as of December 31, 2023 is approximately $932,000. All current contracts expire in 2024.
VTT Research Contract Extension
On January 31, 2024, the Company entered into the Third Amendment to the commission contract concerning VTT Technical Research Centre of Finland Ltd. ("VTT”) to
develop Dyadic’s C1 fungal expression system for therapeutic protein production. The original contract was entered on June 28, 2019, and subsequently amended by the First
Amendment on June 21, 2022 and the Second Amendment on September 9, 2022. Under the terms of the Third Amendment, the contract duration is extended to January 31, 2025
and Dyadic will pay VTT approximately a total of EUR €186,000 to continue developing Dyadic’s C1-cell protein production platform for therapeutic protein production, including
C1 host system. Dyadic retains the right to terminate the contract with 90 days’ notice.
F- 17
Legal Proceedings
We are not currently involved in any litigation that we believe could have a materially adverse effect in our financial condition or results of operations. From time to time,
the Company is subject to legal proceedings, asserted claims and investigations in the ordinary course of business, including commercial claims, employment and other matters,
which management considers immaterial, individually and in the aggregate. The Company makes a provision for a liability when it is both probable that a liability has been incurred
and the amount of the loss can be reasonably estimated. The requirement for these provisions is reviewed at least quarterly and adjusted to reflect the impact of negotiations,
settlements, rulings, advice of legal counsel and other information and events pertaining to a particular case. Litigation is inherently unpredictable and costly. Protracted litigation
and/or an unfavorable resolution of one or more of proceedings, claims or investigations against the Company could have a material adverse effect on the Company’s consolidated
financial position, cash flows or results of operations.
Note 6: Share-Based Compensation
Description of Equity Plans
The 2021 Equity Incentive Award Plan (the "2021 Plan”) was adopted by the Company's Board of Directors on April 9, 2021, and approved by the Company’s Annual
Meeting of Shareholders (the "Annual Meeting”) on June 11, 2021. The 2021 Plan serves as a successor to the Company’s 2011 Equity Incentive Plan (the "2011 Plan”). Since the
adoption of the 2021 Plan, all equity awards were made from the 2021 Plan and no additional awards will be granted under the 2011 Plan. The 2021 Plan provides for the issuance of
a variety of share-based compensation awards, including stock options, restricted stock awards, restricted stock unit awards, performance awards, dividend equivalents awards,
deferred stock awards, stock payment awards and stock appreciation rights. As of April 16, 2021, the 2021 Plan increased the number of shares available for grant by 3,000,000 in
addition to the number of shares remaining available for the grant of new awards under the 2011.
As of December 31, 2023, the Company had 5,469,247 stock options outstanding and an additional 2,773,406 shares of common stock available for grant under the 2021
Plan. As of December 31, 2022, there were 5,031,097 stock options outstanding and an additional 3,672,561 shares of common stock available for grant under the 2021 Plan.
Stock Options
Options are granted to purchase common stock at prices that are equal to the fair value of the common stock on the date the option is granted. Vesting is determined by
the Board of Directors at the time of grant. The term of any stock option awards under the Company’s 2011 Plan and 2021 Plan is ten years, except for certain options granted to the
contractors which are either one or three years.
The grant-date fair value of each option grant is estimated using the Black-Scholes option pricing model and amortized on a straight-line basis over the requisite service
period, which is generally the vesting period, for each separately vesting portion of the award as if the award was, in substance, multiple awards. Use of a valuation model requires
management to make certain assumptions with respect to selected model inputs, including the following:
Risk-free interest rate. The risk-free interest rate is based on U.S. Treasury rates with securities approximating the expected lives of options at the date of grant.
Expected dividend yield. The expected dividend yield is zero, as the Company has never paid dividends to common shareholders and does not currently anticipate
paying any in the foreseeable future.
Expected stock price volatility. The expected stock price volatility was calculated based on the Company’s own volatility. The Company reviews its volatility assumption
on an annual basis and has used the Company’s historical volatilities.
Expected life of option. The expected life of option was based on the contractual term of the option and expected employee exercise and post-vesting employment
termination behavior. The Company uses the weighted average vesting period and contractual term of the option as the best estimate of the expected life of a new option, except
for the options granted to the CEO (i.e., 5 or 10 years) and certain contractors (i.e., 1 or 3 years).
The assumptions used in the Black-Scholes option pricing model for stock options granted for the years ended December 31, 2023 and 2022 are as follows:
Risk-free interest rate
Expected dividend yield
Expected stock price volatility
Expected life of options (in years)
F- 18
Years Ended December 31,
2023
3.90% -5.12%
—%
62.22% - 64.27%
1.13 -6.25
2022
1.40% - 3.24%
—%
61.30% - 61.58%
5.5 - 6.25
The following table summarizes the combined stock option activity under the Company’s Equity Compensation Plans:
Outstanding at December 31, 2021
Granted
Exercised
Expired
Canceled
Outstanding at December 31, 2022
Granted (1)
Exercised
Expired (2)
Canceled (3)
Outstanding at December 31, 2023
Exercisable at December 31, 2023
Weighted-
Average
Remaining
Contractual
Exercise Price Term (Years)
Weighted-
Average
Shares
Aggregate
Intrinsic
Value
4,774,215 $
865,825
(333,943)
(200,000)
(75,000)
5,031,097 $
805,350
—
(351,520)
(15,680)
5,469,247 $
4,160,298 $
3.04
4.43
1.63
5.47
4.81
3.25
1.45
—
1.71
3.50
3.08
3.15
6.14 $
8,413,444
5.75 $
13,000
5.66 $
4.81 $
322,738
161,427
Notes:
(1) Represents the following stock options granted:
•
•
Annual share-based compensation awards on January 3, 2023, including: (a) 406,250 stock options with an exercise price of $1.38 per share granted to executives and key
personnel, upon one year anniversary, or vesting annually in equal installments over four years, (b) 262,500 stock options with an exercise price of $1.38 per share granted
to members of the Board of Directors, vesting upon one year anniversary, (c) 24,100 stock options with an exercise price of $1.38 per share granted to employees, vesting
annually in equal installments over four years, and (d) 15,000 stock options with an exercise price of $1.38 per share granted to a consultant, vesting upon one year
anniversary.
Throughout the year the following stock options were granted: (a) on May 30, 2023, 37,500 stock options with an exercise price of $2.23 per share granted to a consultant,
vesting over two months from the grant date, (b) on September 15, 2023, 55,000 stock options with an exercise price of $1.75 per share granted to a consultant, vesting over
a year and half from the grant date, and (c) on October 23, 2023, 5,000 stock options with an exercise price of $1.66 per share granted to an employee vesting annually in
equal installments over four years.
(2) Represents the following stock options expired:
•
270,000 stock options with an exercise price of $1.39 per share granted to executive, (b) 25,000 stock options with an exercise price of $3.99 per share granted to a
consultant, (c) 25,000 stock options with an exercise price of $1.75 per share granted to a member of the Board of Directors, (d) 31,520 stock options with an exercise price
ranging between $1.39 and $5.27 per share granted to a former employee.
(3) Represents the cancellation of unvested portion of the stock options granted previously to a former employee with exercise price ranging between $1.39 to $5.27.
The weighted average grant-date fair market value of stock options granted for the years ended December 31, 2023 and 2022 was $0.81 and $2.49, respectively, based on
the Black-Scholes option pricing model. The intrinsic value of options exercised for the years ended December 31, 2023 and 2022 was $0 and $365,000, respectively.
As of December 31, 2023 and 2022, total unrecognized compensation cost related to non-vested stock options granted under the Company’s equity compensation plans
was $559,121 and $919,000, respectively, which is expected to be recognized over a weighted average period of 2.68 years and 2.76 years, respectively. The Company adjusts
unrecognized compensation cost for actual forfeitures as they occur.
Restricted Stock Units
Restricted stock units (the "RSUs”) are granted subject to certain restrictions. Vesting conditions are determined at the discretion of the Board of Directors. The fair
market value of RSUs is generally determined based on the closing market price of the stock on the grant date.
The following table summarizes the restricted stock award activity during the year ended December 31, 2023:
Outstanding at December 31, 2022
Granted (1)
Vested (1)
Outstanding at December 31, 2023
Notes:
Weighted-Average
Grant Date
Fair Value
Shares
— $
461,005
(247,961)
213,044 $
—
1.38
1.38
1.38
(1) On January 3, 2023, the Company granted 247,961 RSUs with immediate vesting, to executives and key personnel in lieu of cash bonuses earned for the year ended 2022. The
Company also granted 163,044 RSUs, vesting upon one year anniversary of the grant, to the Board of Directors as a result of the Board agreeing to a reduction in director cash
compensation for 2023. On December 6, 2023, the Company granted 50,000 RSUs to a consultant, vesting at the end of the service period.
F- 19
Compensation Expenses
We recognize all share-based payments to employees, consultants, and our Board, as non-cash compensation expense, in research and development expenses or general
and administrative expenses in the consolidated statement of operations, and these charges had no impact on the Company’s reported cash flows. Stock-based compensation
expense is calculated on the grant date fair values of such awards, and recognized each period based on the value of the portion of share-based payment awards that is ultimately
expected to vest during the period. Forfeitures are recorded as they occur.
For performance-based awards, the Company recognizes related stock-based compensation expenses based upon its determination of the potential likelihood of
achievement of the specified performance conditions at each reporting date. There was no performance-based award recognized during the years ended December 31, 2023 and
2022.
Total non-cash stock option compensation expense was allocated among the following expense categories:
General and administrative
Research and development
Total
The following table summarizes the Company’s non-cash share-based compensation expenses:
Share based compensation expense- stock options
Share based compensation expense- restricted stock units
Total
Note 7: Shareholders’ Equity
Issuances of Common Stock
Years Ended December 31,
2023
2022
1,201,027 $
43,094
1,244,121 $
1,661,025
227,919
1,888,944
Years Ended December 31,
2023
2022
1,004,054 $
240,067
1,244,121 $
1,888,944
—
1,888,944
$
$
$
$
For the year ended December 31, 2023, there were 247,961 shares of the Company’s common stock issued resulting from the vesting of restricted stock units with a
weighted average issue price of $1.38 per share. For the year ended December 31, 2022, there were 333,943 shares of the Company’s common stock issued resulting from the
exercise of stock options, with a weighted average issue price of $1.63 per share.
Treasury Stock
As of December 31, 2023, and 2022, there were 12,253,502 shares of common stock held in treasury, at a cost of approximately $18.9 million, representing the purchase price
on the date the shares were surrendered to the Company.
Note 8: Subsequent Events
For purpose of disclosure in the consolidated financial statements, the Company has evaluated subsequent events through March 28, 2024, the date the consolidated
financial statements were available to be issued. Except for items mentioned in the notes, and as discussed below, management is not aware of any material events that have
occurred subsequent to the balance sheet date that would require adjustment to, or disclosure in the accompanying financial statements.
2024 Annual Grants
On January 2, 2024, the Company granted an annual stock option award with an exercise price of $1.59, including: (a) 387,500 stock options granted to executives and key
personnel, vesting upon one year anniversary, or annually in equal installments over four years, (b) 352,500 stock options granted to members of the Board of Directors, vesting
upon one year anniversary, (c) 17,600 stock options granted to employees, vesting annually in equal installments over four years, and (d)15,000 stock options granted to a
consultant, vesting upon one year anniversary.
On January 2, 2024, the Company granted 141,510 restricted stock units, vesting upon one year anniversary, to the Board of Directors as a result of reduction in director
cash compensation of 2024. The grant of these RSUs has been approved by the Compensation Committee of the Board of Directors in December 2023.
On March 11, 2024, the Compensation Committee of the Board of Directors approved and granted an aggregate of 212,709 restricted stock units, vested in full, to
executives and key personnel in lieu of cash bonus earned for the year ended December 31, 2023.
F- 20
Senior Secured Convertible Promissory Notes
On March 8, 2024, the Company entered into a securities purchase agreement (the "Securities Purchase Agreement”) pursuant to which the Company issued 8.0% Senior
Secured Convertible Promissory Notes due March 8, 2027 in an aggregate principal amount of $6.0 million (the "Convertible Notes”). The purchasers of the Convertible Notes
include immediate family members and family trusts related to Mark Emalfarb, our President and Chief Executive Officer and a member of our Board of Directors, including The
Francisco Trust U/A/D February 28, 1996, an existing holder of more than 5% of our outstanding common stock, (collectively, the "Purchasers”). The Convertible Notes were sold
in a private placement in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended. The net proceeds from the sale of the
Convertible Notes, after deducting offering expenses, will be approximately $5,850,000. The Company intends to use the net proceeds from the offering of the Convertible Notes for
working capital and general corporate purposes.
The Convertible Notes will be senior, secured obligations of the Company and its affiliates, and interest will be payable quarterly in cash on the principal amount equal to
8% per annum, and guaranteed by Dyadic International (USA), Inc. under a subsidiary guarantee for the benefit of the holders of the Convertible Notes (each such holder, a
"Holder”).
The Convertible Notes will mature on March 8, 2027, unless earlier converted or redeemed in accordance with the terms of the Convertible Notes. The Convertible Notes
are secured by a first priority lien on substantially all assets of the Company and its subsidiary, Dyadic International (USA), Inc., pursuant to the Security Agreement (as defined
below).
The Convertible Notes are convertible into shares of the Company’s common stock, in whole or in part, at the option of the Holders at any time, based on an initial
conversion price of $1.79 per share of common stock, subject to adjustment in certain circumstances; provided that the Company shall not effect any Conversion of a Note and the
Holder thereof shall not have any right to convert any portion of such Note to the extent that, after giving effect to such conversion, such Holder would beneficially own shares of
the company in excess of the limits provided in the applicable Convertible Notes; provided further that the Company shall not issue any common stock pursuant to the terms of the
Convertible Notes if such issuance would exceed 19.99% of the Company’s issued and outstanding Common Stock on date of the Purchase Agreement or otherwise exceed the
aggregate number of shares of Common Stock which the Company may issue without breaching the Company’s obligations under the rules or regulations of Nasdaq.
The Holders may require the Company to redeem all or any part of the Convertible Notes on a redemption date falling on any of the 18, 21, 24, 27, 30, and 33-month
anniversaries of the original issue date of the Convertible Notes (any such date, a "Redemption Date”) upon not less than 60 calendar days written notice prior to the applicable
Redemption Date. The Company may also elect to redeem all or any part of the Convertible Notes on a Redemption Date upon not less than 60 calendar days written notice prior to
the applicable Redemption Date.
The Convertible Notes contain customary terms and covenants and customary events of default ("Events of Default”). Upon the occurrence of any Event of Default, at
the Holder’s election, the outstanding principal amount of the applicable Convertible Notes, plus accrued but unpaid interest, liquidated damages, and other amounts owing in
respect thereof through the date of acceleration, shall become immediately due and payable. After the occurrence of any Event of Default that results in the eventual acceleration
of any Note, the interest rate on such Note shall accrue at an interest rate equal to 18% per annum (with a credit for any "unused” guaranteed interest).
The Securities Purchase Agreement also contains certain affirmative and negative covenants (including, without limitation, restrictions on our ability to incur
indebtedness, permit liens, make dividends or certain debt payments or consummate certain affiliate transactions) and customary representations and warranties of the Company
and the Purchasers, indemnification obligations of the Company, termination provisions, and other obligations and rights of the parties.
The Company also entered into a registration rights agreement (the "Registration Rights Agreement”) with the Purchasers, pursuant to which the Company has agreed to
register under the Securities Act any common stock of the Company issuable upon conversion of the Convertible Notes.
The Company also entered into a security agreement (the "Security Agreement”) with the Purchasers, pursuant to which the Company granted the Purchasers a
continuing security interest in certain collateral to secure the full and prompt payment, performance and observance of all present and future indebtedness, obligations, liabilities
and agreements of any kind of the Company to the Purchasers arising under or in connection with the Convertible Notes.
Dyadic International (USA), Inc., a subsidiary of the Company (the "Guarantor”) also entered into a subsidiary guarantee (the "Subsidiary Guarantee”) with the
Purchasers, pursuant to which the Guarantor has guaranteed to the Purchasers the prompt and complete payment and performance when due of the obligations under the
Securities Purchase Agreement.
F-21
DYADIC INTERNATIONAL, INC.
2021 EQUITY INCENTIVE AWARD PLAN
STOCK OPTION GRANT NOTICE
Exhibit 10.2.1
Dyadic International, Inc., a Delaware corporation, (the "Company”), pursuant to its 2021 Equity Incentive Award Plan, as amended from time to time (the " Plan”), hereby
grants to the Holder listed below ("Participant”), an option to purchase the number of shares of the Company’s common stock, par value $0.001 (" Stock”), set forth below (the
"Option”). This Option is subject to all of the terms and conditions set forth herein and in the Stock Option Agreement attached hereto as Exhibit A (the "Stock Option
Agreement”) and the Plan, each of which are incorporated herein by reference. Unless otherwise defined herein, the terms defined in the Plan shall have the same defined meanings
in this Grant Notice and the Stock Option Agreement.
Participant Name:
Participant ID:
Plan Name:
Award Number:
Shares Granted:
Award Type:
Award Date:
Award Price:
Vesting Schedule:
Expiration Date:
By signing the Stock Option Grant Notice below and the Stock Option Agreement attached hereto as Exhibit A, Participant agrees to be bound by the terms and conditions
of the Plan, the Stock Option Agreement and this Grant Notice. Participant has reviewed the Stock Option Agreement, the Plan and this Grant Notice in their entirety, has had an
opportunity to obtain the advice of counsel prior to executing this Grant Notice and the Stock Option Agreement and fully understands all provisions of this Grant Notice, the
Stock Option Agreement and the Plan. Participant hereby agrees to accept as binding, conclusive and final all decisions or interpretations of the Administrator upon any questions
arising under the Plan, this Grant Notice or the Stock Option Agreement.
DYADIC INTERNATIONAL, INC.:
By:
Print Name:
Title:
PARTICIPANT:
Signature:
Print Name:
DYADIC INTERNATIONAL, INC.
STOCK OPTION AGREEMENT
EXHIBIT A
Pursuant to the Stock Option Grant Notice (the "Grant Notice”) to which this Stock Option Agreement (this " Agreement”) is attached, Dyadic International, Inc., a Delaware
corporation (the "Company”), has granted to Participant an Option under the Company’s 2021 Equity Incentive Award Plan, as amended from time to time (the " Plan”), to purchase
the number of shares of Stock indicated in the Grant Notice.
ARTICLE 1.
GENERAL
1.1 Defined Terms. Wherever the following terms are used in this Agreement they shall have the meanings specified below, unless the context clearly indicates otherwise.
Capitalized terms not specifically defined herein shall have the meanings specified in the Plan and the Grant Notice.
1.2 Incorporation of Terms of Plan. The Option is subject to the terms and conditions of the Plan which are incorporated herein by reference. In the event of any
inconsistency between the Plan and this Agreement, the terms of the Plan shall control.
ARTICLE 2.
GRANT OF OPTION
2.1 Grant of Option. In consideration of Participant’s past and/or continued employment with or service to the Company or a Subsidiary and for other good and valuable
consideration, effective as of the Grant Date set forth in the Grant Notice (the "Grant Date”), the Company grants to Participant the Option to purchase any part or all of an
aggregate of the number of shares of Stock set forth in the Grant Notice, upon the terms and conditions set forth in the Plan and this Agreement, subject to adjustments as
provided in Section 14.2 of the Plan. Unless designated as a Nonstatutory Stock Option in the Grant Notice, the Option shall be an Incentive Stock Option to the maximum extent
permitted by law.
2.2 Exercise Price. The exercise price of the shares of Stock subject to the Option shall be as set forth in the Grant Notice, without commission or other charge; provided,
however, that the price per share of the shares of Stock subject to the Option shall not be less than 100% of the Fair Market Value of a share of Stock on the Grant Date.
Notwithstanding the foregoing, if this Option is designated as an Incentive Stock Option and Participant owns (within the meaning of Section 424(d) of the Code) more than 10% of
the total combined voting power of all classes of stock of the Company or any "subsidiary corporation” of the Company or any "parent corporation” of the Company (each within
the meaning of Section 424 of the Code), the price per share of the shares of Stock subject to the Option shall not be less than 110% of the Fair Market Value of a share of Stock on
the Grant Date.
2.3 Consideration to the Company. In consideration of the grant of the Option by the Company, Participant agrees to render faithful and efficient services to the Company or
any Subsidiary. Nothing in the Plan or this Agreement shall confer upon Participant any right to continue in the employ or service of the Company or any Subsidiary or shall
interfere with or restrict in any way the rights of the Company and its Subsidiaries, which rights are hereby expressly reserved, to discharge or terminate the services of Participant
at any time for any reason whatsoever, with or without cause, except to the extent expressly provided otherwise in a written agreement between the Company or a Subsidiary and
Participant.
ARTICLE 3.
PERIOD OF EXERCISABILITY
3.1 Commencement of Exercisability.
(a) Subject to Sections 3.2, 3.3, 5.10 and 5.16 hereof, the Option shall become vested and exercisable in such amounts and at such times as are set forth in the Grant
Notice.
2
(b) No portion of the Option which has not become vested and exercisable at the date of Participant’s Termination of Service shall thereafter become vested and
exercisable, except as may be otherwise provided by the Administrator or as set forth in a written agreement between the Company and Participant.
(c) Notwithstanding Sections 3.1(a) hereof and the Grant Notice, but subject to Section 3.1(b) hereof, pursuant to Section 14.2 of the Plan, the Option shall become fully
vested and exercisable with respect to all shares of Stock covered thereby in the event of a Change in Control, in connection with which the successor corporation does not
assume the Option or substitute an equivalent right for the Option. Should the successor corporation assume the Option or substitute an equivalent right, then no such
acceleration shall apply.
3.2 Duration of Exercisability. The installments provided for in the vesting schedule set forth in the Grant Notice are cumulative. Each such installment which becomes vested
and exercisable pursuant to the vesting schedule set forth in the Grant Notice shall remain vested and exercisable until it becomes unexercisable under Section 3.3 hereof.
3.3 Expiration of Option. The Option may not be exercised to any extent by anyone after the first to occur of the following events:
(a) The Expiration Date set forth in the Grant Notice, which shall in no event be more than ten (10) years from the Grant Date;
(b) If this Option is designated as an Incentive Stock Option and Participant owned (within the meaning of Section 424(d) of the Code), at the time the Option was
granted, more than 10% of the total combined voting power of all classes of stock of the Company or any "subsidiary corporation” of the Company or any "parent corporation” of
the Company (each within the meaning of Section 424 of the Code), the expiration of five (5) years from the Grant Date;
(c) The expiration of three (3) months from the date of Participant’s Termination of Service, unless such termination occurs by reason of Participant’s death or
disability; or
(d) The expiration of one (1) year from the date of Participant’s Termination of Service by reason of Participant’s death or disability.
3.4 Special Tax Consequences. Participant acknowledges that, to the extent that the aggregate Fair Market Value (determined as of the time the Option is granted) of all
shares of Stock with respect to which Incentive Stock Options, including the Option (if applicable), are exercisable for the first time by Participant in any calendar year exceeds
$100,000, the Option and such other options shall be Nonstatutory Stock Options to the extent necessary to comply with the limitations imposed by Section 422(d) of the Code.
Participant further acknowledges that the rule set forth in the preceding sentence shall be applied by taking the Option and other "incentive stock options” into account in the
order in which they were granted, as determined under Section 422(d) of the Code and the Treasury Regulations thereunder. Participant also acknowledges that an Incentive Stock
Option exercised more than three (3) months after Participant’s Termination of Employment, other than by reason of death or disability, will be taxed as a Nonstatutory Stock
Option.
3.5 Tax Indemnity.
(a) The Participant agrees to indemnify and keep indemnified the Company, any Subsidiary and his/her employing company, if different, from and against any liability
for or obligation to pay any Tax Liability (a "Tax Liability” being any liability for income tax, withholding tax and any other employment related taxes or social security contributions
in any jurisdiction) that is attributable to (1) the grant or exercise of, or any benefit derived by the Participant from, the Option, (2) the acquisition by the Participant of the Stock on
exercise of the Option, or (3) the disposal of any Stock.
(b) The Option cannot be exercised until the Participant has made such arrangements as the Company may require for the satisfaction of any Tax Liability that may
arise in connection with the exercise of the Option and/or the acquisition of the Stock by the Participant. The Company shall not be required to issue, allot or transfer Stock until
the Employee has satisfied this obligation.
3
ARTICLE 4.
EXERCISE OF OPTION
4.1 Person Eligible to Exercise. During the lifetime of Participant, only Participant may exercise the Option or any portion thereof. After the death of Participant, any
exercisable portion of the Option may, prior to the time when the Option becomes unexercisable under Section 3.3 hereof, be exercised by Participant’s personal representative or
by any person empowered to do so under the deceased Participant’s will or under the then applicable laws of descent and distribution.
4.2 Partial Exercise. Any exercisable portion of the Option or the entire Option, if then wholly exercisable, may be exercised in whole or in part at any time prior to the time
when the Option or portion thereof becomes unexercisable under Section 3.3 hereof.
4.3 Manner of Exercise. The Option, or any exercisable portion thereof, may be exercised solely by delivery to the Secretary of the Company (or any third-party administrator
or other person or entity designated by the Company), during regular business hours, of all of the following prior to the time when the Option or such portion thereof becomes
unexercisable under Section 3.3 hereof:
(a) An exercise notice in a form specified by the Administrator, stating that the Option or portion thereof is thereby exercised, such notice complying with all applicable
rules established by the Administrator;
(b) The receipt by the Company of full payment for the shares of Stock with respect to which the Option or portion thereof is exercised, including payment of any
applicable withholding tax, which shall be made by deduction from other compensation payable to Participant or in such other form of consideration permitted under Section 4.4
hereof that is acceptable to the Company;
(c) Any other written representations as may be required in the Administrator’s reasonable discretion to evidence compliance with the Securities Act or any other
applicable law, rule or regulation; and
(d) In the event the Option or portion thereof shall be exercised pursuant to Section 4.1 hereof by any person or persons other than Participant, appropriate proof of
the right of such person or persons to exercise the Option.
Notwithstanding any of the foregoing, the Company shall have the right to specify all conditions of the manner of exercise, which conditions may vary by country, and which may
be subject to change from time to time.
4.4 Method of Payment. Payment of the exercise price shall be by any of the following, or a combination thereof, at the election of Participant:
(a) Cash or check;
(b) With the consent of the Administrator, surrender of shares of Stock (including, without limitation, shares of Stock otherwise issuable upon exercise of the Option)
held for such period of time as may be required by the Administrator in order to avoid adverse accounting consequences and having a Fair Market Value on the date of delivery
equal to the aggregate exercise price of the Option or exercised portion thereof; or
(c) Other property acceptable to the Administrator (including, without limitation, through the delivery of a notice that Participant has placed a market sell order with a
broker with respect to shares of Stock then issuable upon exercise of the Option, and that the broker has been directed to pay a sufficient portion of the net proceeds of the sale to
the Company in satisfaction of the Option exercise price; provided that payment of such proceeds is then made to the Company at such time as may be required by the Company,
but in any event not later than the settlement of such sale).
4
4.5 Conditions to Issuance of Stock. The shares of Stock deliverable upon the exercise of the Option, or any portion thereof, may be either previously authorized but
unissued shares of Stock or issued shares of Stock which have then been reacquired by the Company. Such shares of Stock shall be fully paid and nonassessable. The Company
shall not be required to issue or deliver any shares of Stock purchased upon the exercise of the Option or portion thereof prior to fulfillment of all of the following conditions:
(a) The admission of such shares of Stock to listing on all stock exchanges on which such Stock is then listed;
(b) The completion of any registration or other qualification of such shares of Stock under any state or federal law or under rulings or regulations of the Securities and
Exchange Commission or of any other governmental regulatory body, which the Administrator shall, in its absolute discretion, deem necessary or advisable;
(c) The obtaining of any approval or other clearance from any state or federal governmental agency which the Administrator shall, in its absolute discretion, determine
to be necessary or advisable;
(d) The receipt by the Company of full payment for such shares of Stock, including payment of any applicable withholding tax, which may be in one or more of the
forms of consideration permitted under Section 4.4 hereof; and
(e) The lapse of such reasonable period of time following the exercise of the Option as the Administrator may from time to time establish for reasons of administrative
convenience.
4.6 Rights as Stockholder. The holder of the Option shall not be, nor have any of the rights or privileges of, a stockholder of the Company, including, without limitation,
voting rights and rights to dividends, in respect of any shares of Stock purchasable upon the exercise of any part of the Option unless and until such shares of Stock shall have
been issued by the Company and held of record by such holder (as evidenced by the appropriate entry on the books of the Company or of a duly authorized transfer agent of the
Company). No adjustment will be made for a dividend or other right for which the record date is prior to the date the shares of Stock are issued, except as provided in Section 14.2
of the Plan.
ARTICLE 5.
OTHER PROVISIONS
5.1 Administration. The Administrator shall have the power to interpret the Plan and this Agreement and to adopt such rules for the administration, interpretation and
application of the Plan as are consistent therewith and to interpret, amend or revoke any such rules. All actions taken and all interpretations and determinations made by the
Administrator in good faith shall be final and binding upon Participant, the Company and all other interested persons. No member of the Committee or the Board shall be personally
liable for any action, determination or interpretation made in good faith with respect to the Plan, this Agreement or the Option.
5.2 Whole Shares. The Option may only be exercised for whole shares of Stock.
5.3 Option Not Transferable. Subject to Section 4.1 hereof, the Option may not be sold, pledged, assigned or transferred in any manner other than by will or the laws of
descent and distribution, unless and until the shares of Stock underlying the Option have been issued, and all restrictions applicable to such shares of Stock have lapsed. Neither
the Option nor any interest or right therein shall be liable for the debts, contracts or engagements of Participant or his or her successors in interest or shall be subject to disposition
by transfer, alienation, anticipation, pledge, encumbrance, assignment or any other means whether such disposition be voluntary or involuntary or by operation of law by
judgment, levy, attachment, garnishment or any other legal or equitable proceedings (including bankruptcy), and any attempted disposition thereof shall be null and void and of no
effect, except to the extent that such disposition is permitted by the preceding sentence.
5.4 Binding Agreement. Subject to the limitation on the transferability of the Option contained herein, this Agreement will be binding upon and inure to the benefit of the
heirs, legatees, legal representatives, successors and assigns of the parties hereto.
5.5 Adjustments Upon Specified Events. The Administrator may accelerate the vesting of the Option in such circumstances as it, in its sole discretion, may determine. In
addition, upon the occurrence of certain events relating to the Stock contemplated by Section 14.2 of the Plan (including, without limitation, an extraordinary cash dividend on such
Stock), the Administrator shall make such adjustments the Administrator deems appropriate in the number of shares of Stock subject to the Option, the exercise price of the Option
and the kind of securities that may be issued upon exercise of the Option. Participant acknowledges that the Option is subject to adjustment, modification and termination in certain
events as provided in this Agreement and Section 14.2 of the Plan.
5
5.6 Notices. Any notice to be given under the terms of this Agreement to the Company shall be addressed to the Company in care of the Secretary of the Company at the
Company’s principal office, and any notice to be given to Participant shall be addressed to Participant at Participant’s last address reflected on the Company’s records. By a notice
given pursuant to this Section 5.6, either party may hereafter designate a different address for notices to be given to that party. Any notice which is required to be given to
Participant shall, if Participant is then deceased, be given to the person entitled to exercise his or her Option pursuant to Section 4.1 hereof by written notice under this Section 5.6.
Any notice shall be deemed duly given when sent via email or when sent by certified mail (return receipt requested) and deposited (with postage prepaid) in a post office or branch
post office regularly maintained by the United States Postal Service.
5.7 Titles. Titles are provided herein for convenience only and are not to serve as a basis for interpretation or construction of this Agreement.
5.8 Governing Law. The laws of the State of Delaware shall govern the interpretation, validity, administration, enforcement and performance of the terms of this Agreement
regardless of the law that might be applied under principles of conflicts of laws.
5.9 Conformity to Securities Laws. Participant acknowledges that the Plan and this Agreement are intended to conform to the extent necessary with all provisions of the
Securities Act and the Exchange Act and any and all regulations and rules promulgated by the Securities and Exchange Commission thereunder, and state securities laws and
regulations. Notwithstanding anything herein to the contrary, the Plan shall be administered, and the Option is granted and may be exercised, only in such a manner as to conform
to such laws, rules and regulations. To the extent permitted by applicable law, the Plan and this Agreement shall be deemed amended to the extent necessary to conform to such
laws, rules and regulations.
5.10 Amendments, Suspension and Termination. To the extent permitted by the Plan, this Agreement may be wholly or partially amended or otherwise modified, suspended
or terminated at any time or from time to time by the Committee or the Board; provided that, except as may otherwise be provided by the Plan, no amendment, modification,
suspension or termination of this Agreement shall adversely affect the Option in any material way without the prior written consent of Participant.
5.11 Successors and Assigns. The Company may assign any of its rights under this Agreement to single or multiple assignees, and this Agreement shall inure to the benefit
of the successors and assigns of the Company. Subject to the restrictions on transfer herein set forth in Section 5.3 hereof, this Agreement shall be binding upon Participant and
his or her heirs, executors, administrators, successors and assigns.
5.12 Notification of Disposition. If this Option is designated as an Incentive Stock Option, Participant shall give prompt notice to the Company of any disposition or other
transfer of any shares of Stock acquired under this Agreement if such disposition or transfer is made (a) within two (2) years from the Grant Date with respect to such shares of
Stock or (b) within one (1) year after the transfer of such shares of Stock to Participant. Such notice shall specify the date of such disposition or other transfer and the amount
realized, in cash, other property, assumption of indebtedness or other consideration, by Participant in such disposition or other transfer.
5.13 Limitations Applicable to Section 16 Persons. Notwithstanding any other provision of the Plan or this Agreement, if Participant is subject to Section 16 of the Exchange
Act, the Plan, the Option and this Agreement shall be subject to any additional limitations set forth in any applicable exemptive rule under Section 16 of the Exchange Act
(including any amendment to Rule 16b-3 of the Exchange Act) that are requirements for the application of such exemptive rule. To the extent permitted by applicable law, this
Agreement shall be deemed amended to the extent necessary to conform to such applicable exemptive rule.
5.14 Not a Contract of Employment. Nothing in this Agreement or in the Plan shall confer upon the Participant any right to continue to serve as an employee or other service
provider of the Company or any of its Subsidiaries.
5.15 Entire Agreement. The Plan, the Grant Notice and this Agreement (including all Exhibits thereto) constitute the entire agreement of the parties and supersede in their
entirety all prior undertakings and agreements of the Company and Participant with respect to the subject matter hereof.
6
5.16 Section 409A. This Option is not intended to constitute "nonqualified deferred compensation” within the meaning of Section 409A of the Code (together with any
Department of Treasury regulations and other interpretive guidance issued thereunder, including without limitation any such regulations or other guidance that may be issued after
the date hereof, "Section 409A”). However, notwithstanding any other provision of the Plan, the Grant Notice or this Agreement, if at any time the Administrator determines that
the Option (or any portion thereof) may be subject to Section 409A, the Administrator shall have the right in its sole discretion (without any obligation to do so or to indemnify
Participant or any other person for failure to do so) to adopt such amendments to the Plan, the Grant Notice or this Agreement, or adopt other policies and procedures (including
amendments, policies and procedures with retroactive effect), or take any other actions, as the Administrator determines are necessary or appropriate either for the Option to be
exempt from the application of Section 409A or to comply with the requirements of Section 409A.
5.17 Limitation on Participant’s Rights. Participation in the Plan confers no rights or interests other than as herein provided. This Agreement creates only a contractual
obligation on the part of the Company as to amounts payable and shall not be construed as creating a trust. Neither the Plan nor any underlying program, in and of itself, has any
assets. Participant shall have only the rights of a general unsecured creditor of the Company with respect to amounts credited and benefits payable, if any, with respect to the
Option, and rights no greater than the right to receive the Stock as a general unsecured creditor with respect to options, as and when exercised pursuant to the terms hereof.
5.18 Award Subject to Company Clawback or Recoupment. To the extent permitted by applicable law, the Restricted Stock Units or any Common Stock issued in settlement
thereof will be subject to clawback or recoupment pursuant to any compensation clawback or recoupment policy adopted by the Board or required by law during the term of your
service with the Company or its affiliates.
IN WITNESS WHEREOF, the Company has caused a duly authorized officer to execute this Agreement, and Participant has executed this Agreement, effective as of the
Grant Date.
THE COMPANY:
DYADIC INTERNATIONAL, INC.
By:
Print Name:
Title:
PARTICIPANT:
Print Name:
7
DYADIC INTERNATIONAL, INC.
2021 EQUITY INCENTIVE AWARD PLAN
Restricted Stock Unit Award Grant Notice
Exhibit 10.2.2
Dyadic International, Inc., a Delaware corporation, (the "Company”), pursuant to its 2021 Equity Incentive Plan (the "Plan”), hereby grants to the Holder named below a
Restricted Stock Unit Award (the " Award”) for the number of restricted stock units ("Restricted Stock Units”) set forth below. The Award is subject to all of the terms and
conditions as set forth in this Restricted Stock Unit Award Grant Notice (this " Grant Notice”) and in the Restricted Stock Unit Award Agreement (the " RSU Award Agreement ”)
and the Plan, both of which are attached hereto and hereby incorporated herein by reference. Capitalized terms used but not defined in this Grant Notice shall have the meanings
set forth in the RSU Award Agreement or the Plan, as applicable.
Participant Name:
Participant ID:
Plan Name:
Award Number:
Shares Granted:
Award Type:
Award Date:
Vesting Schedule: Subject to the Participant not experiencing a Termination of Service prior to any’s Continuous Service through the applicable vesting date,
the unvested Restricted Stock Units will vest in accordance with the following vesting schedule
Additional Terms/Acknowledgements: The Participant acknowledges receipt of, and understands and agrees to, this Grant Notice, the RSU Award Agreement and the Plan. The
Participant further acknowledges that, as of the Date of Grant, this Grant Notice, the RSU Award Agreement, the Plan and the Participant’s written employment agreement (if any)
with the Company set forth the entire understanding between the Participant and the Company regarding the Restricted Stock Units and supersede all prior oral and written
agreements regarding the Restricted Stock Units. In the event Participant does not execute this Grant Notice within [60] days of the Award Date, this Award shall be deemed [void
ab initio][to have been automatically duly executed and accepted, unless the Participant affirmatively notifies the Company that the Participant does not wish to accept this
Award. Participant’s acceptance of this Award constitutes his or her instruction and authorization to the Company or Employer and any brokerage firm determined acceptable to
the Company or Employer for such purpose to sell on Participant’s behalf shares of Common Stock from those shares issuable to Participant as the Company or Employer
determines to be appropriate to generate cash proceeds sufficient to satisfy Participant’s tax withholding obligation.
DYADIC INTERNATIONAL, INC.:
By:
Print Name:
Title:
Attachments: Restricted Stock Unit Award Agreement and 2021 Equity Incentive Plan
PARTICIPANT:
Signature:
Print Name:
ATTACHMENT I
Restricted Stock Unit Award Agreement
DYADIC INTERNATIONAL, Inc.
2021 Equity Incentive Plan
Pursuant to the attached Restricted Stock Unit Award Grant Notice (the " Grant Notice”) and this Restricted Stock Unit Award Agreement (this " Agreement”), Dyadic
International, Inc. (the "Company”) has granted you a Restricted Stock Unit Award (the " Award”) under its 2021 Equity Incentive Plan (the "Plan”) for the number of restricted
stock units ("Restricted Stock Units”) indicated in the Grant Notice.
Capitalized terms not expressly defined in this Agreement or the Grant Notice but defined in the Plan shall have the same definitions as are set forth in the Plan.
The terms of your Award, in addition to those set forth in the Grant Notice, are as follows.
1. GRANT OF THE AWARD. Your Award represents the right to be issued on a future date one share of Common Stock (subject to any adjustment under Section 3 below)
for each Restricted Stock Unit that vests in accordance with the Grant Notice and this Agreement. As of the Date of Grant, the Company shall credit to a bookkeeping
account maintained by the Company for your benefit (the "Account”) the number of Restricted Stock Units subject to your Award. This Award was granted in
consideration of your services to the Company or an affiliate.
2. VESTING; ACCELERATED VESTING UPON A CORPORATE TRANSACTION. Subject to the limitations contained in this Agreement and unless otherwise provided
in a written employment agreement between you and the Company, your Award shall vest, if at all, in accordance with the vesting schedule set forth in the Grant Notice.
Unless otherwise provided in a written employment agreement between you and the Company, vesting shall cease upon your Termination of Service and the Restricted
Stock Units credited to the Account that were not vested on the date of such termination shall be cancelled and you shall have no further right, title or interest in or to
such Restricted Stock Units or the shares of Common Stock to be issued in respect of the Restricted Stock Units.
3. CAPITALIZATION ADJUSTMENTS. The number of Restricted Stock Units issuable is subject to the adjustment from time to time as provided in Section 14.2 of the Plan.
Any additional Restricted Stock Units or shares of Common Stock that become subject to your Award pursuant to this Section 3 shall be subject, in a manner determined
by the Board, to the same vesting restrictions, restrictions on transfer, and time and manner of delivery as applicable to the other Restricted Stock Units and shares of
Common Stock covered by your Award. Notwithstanding the provisions of this Section 3, no fractional share or right for a fractional share of Common Stock shall be
created pursuant to this Section 3. Any fraction of a share shall be rounded down to the nearest whole share.
4. SECURITIES LAW COMPLIANCE. You shall not be issued any shares of Common Stock under your Award unless the issuance of the shares of Common Stock
issuable in respect of your Award is (a) then registered under the Securities Act or (b) the Company has determined that such issuance would be exempt from the
registration requirements of the Securities Act. Your Award must also comply with other applicable laws and regulations governing your Award, and you shall not receive
such shares of Common Stock if the Company determines that such receipt would not be in material compliance with such laws and regulations.
5. TRANSFER RESTRICTIONS. Prior to the time that shares of Common Stock have been delivered to you, you may not transfer, pledge, sell or otherwise dispose of your
Award or the shares of Common Stock issuable in respect of your Award, except as expressly provided in this Section 5. For example, you may not pledge shares of
Common Stock that may be issued in respect of your Restricted Stock Units as security for a loan. The restrictions on transfer set forth herein shall lapse upon delivery to
you of shares of Common Stock in respect of your vested Restricted Stock Units.
(a) Death. Your Award and the shares of Common Stock issuable in respect of your Award are transferable by the laws of descent and distribution. At your death,
vesting of your Award shall cease and your executor or administrator of your estate shall be entitled to receive, on behalf of your estate, any shares of Common
Stock or other consideration issuable in respect of your Award that vested but were not issued before your death.
(b) Domestic Relations Orders. Upon receiving written permission from the Board or its duly authorized designee, and provided that you and the designated
transferee enter into transfer and other agreements required by the Company, you may transfer your right to receive the distribution of shares of Common Stock
or other consideration hereunder, pursuant to a domestic relations order that contains the information required by the Company to effectuate the transfer. You
are encouraged to discuss the proposed terms of any division of your Award with the Company prior to finalizing the domestic relations order to verify that you
may make such transfer, and if so, to help ensure the required information is contained within the domestic relations order.
6. DATE OF ISSUANCE OF COMMON STOCK. Subject to the satisfaction of the tax withholding obligation set forth in Section 11 of this Agreement, promptly following
the vesting date, and in any event no later than March 15 of the calendar year following the calendar year in which such vesting occurs, the Company shall issue and
deliver to you one share of Common Stock (subject to any adjustment under Section 3 above) for each Restricted Stock Unit that vests on the applicable vesting date. The
form of delivery (e.g., a stock certificate or electronic entry evidencing such shares) shall be determined by the Company. The issuance of shares of Common Stock in
respect of the Restricted Stock Units is intended to comply with Treasury Regulation Section 1.409A-1(b)(4) and shall be construed and administered in such a manner.
7. DIVIDENDS. You shall receive no benefit or adjustment to your Award with respect to any cash dividend, stock dividend or other distribution that does not result from
an Equity Restructuring or other adjustment pursuant to Section 14.2 of the Plan ; provided, however, that this sentence shall not apply with respect to any shares of
Common Stock that are delivered to you in connection with your Award after such shares have been delivered to you.
8. RESTRICTIVE LEGENDS. The shares of Common Stock issued in respect of your Award shall be endorsed with any appropriate securities law legends as determined by
the Company.
9. EMPLOYMENT AGREEMENT. If you have entered into a written employment agreement with the Company, then in the event of any inconsistency between a provision
contained in your employment agreement and a provision contained in this Agreement, the Grant Notice or the Plan, the provision that is more favorable to you shall
prevail.
10. AWARD NOT A SERVICE CONTRACT. Your Award is not an employment or service contract, and nothing in your Award shall be deemed to create in any way
whatsoever any obligation on your part to continue in the employ of the Company or an affiliate, or of the Company or an affiliate to continue your employment. In
addition, nothing in your Award shall obligate the Company or an affiliate, their respective stockholders, Boards of Directors, officers or Employees to continue any
relationship that you might have as a Director or Consultant for the Company or an affiliate.
11. RESPONSIBILITY FOR TAXES. You acknowledges that, to the extent permitted by applicable law, regardless of any action taken by the Company or, if different, any
affiliate employing or retaining you (the "Employer”), the ultimate liability for all income tax, social insurance, payroll tax, fringe benefits tax, payment on account or other
tax-related items related to your participation in the Plan and legally applicable to you ("Tax-Related Items ”) is and remains your responsibility and may exceed any
amount actually withheld by the Company or the Employer. You further acknowledges that the Company and/or the Employer (i) make no representations or undertakings
regarding the treatment of any Tax-Related Items in connection with any aspect of the Restricted Stock Units, including, but not limited to, the grant, vesting or settlement
of the Restricted Stock Units and the subsequent sale of Common Stock acquired pursuant to such settlement and the receipt of any dividends, and (ii) do not commit to
and are under no obligation to structure the terms of the grant or any aspect of the Restricted Stock Units to reduce or eliminate your liability for Tax- Related Items or
achieve any particular tax result.
12. WITHHOLDING OBLIGATION. In the event your Restricted Stock Units are subject to the withholding obligation of the Company or the Employer, prior to any
relevant taxable or tax withholding event, to the extent permitted by applicable law and as applicable, you agree to make arrangements satisfactory to the Company and/or
the Employer to satisfy all Tax-Related Items. In this regard, you authorize the Company and/or the Employer, or their respective agents, at their discretion, to satisfy any
withholding obligations for Tax-Related Items by one or a combination of the following:
(a) withholding from Participant’s wages or other cash compensation paid to Participant by the Company and/or the Employer; or
(b) instructing a broker on Participant’s behalf to sell Shares otherwise issuable to Participant upon vesting of the RSUs sufficient to generate net proceeds
sufficient to satisfy the Company’s minimum statutory withholding obligations with respect to the income recognized by Participant upon the vesting of the
RSUs (based on minimum statutory withholding rates for all tax purposes, including payroll and social security taxes, that are applicable to such income) and the
net proceeds of such sale shall be submitted to the Company;
(c) withholding Shares to be issued upon settlement of the RSUs, provided the Company only withholds the number of Shares necessary to satisfy no more than the
maximum applicable statutory withholding amounts;
(d) Participant’s payment of a cash amount (including by check representing readily available funds or a wire transfer); or
(e) any other arrangement approved by the Committee and permitted under applicable law;
all under such rules as may be established by the Committee and in compliance with the Company’s Security Trading Policy and 10b5-1 Trading Plan Policy. Until
determined otherwise by the Company, clause (ii) will be the method by which such withholding obligations are satisfied.
Depending on the withholding method, the Company may withhold or account for Tax-Related Items by considering applicable statutory withholding rates or other
applicable withholding rates, including up to the maximum permissible statutory rate for your tax jurisdiction(s) in which case you will have no entitlement to the
equivalent amount in Common Shares and will receive a refund of any over-withheld amount in cash in accordance with applicable law. If the obligation for Tax-Related
Items is satisfied by withholding in Common Stock, for tax purposes, you will be deemed to have been issued the full number of shares of Common Stock subject to the
vested Restricted Stock Units, notwithstanding that a number of the shares of Common Stock are held back solely for the purpose of satisfying the withholding obligation
for Tax-Related Items.
You agree to pay to the Company and/or the Employer any amount of Tax-Related Items that the Company and/or the Employer may be required to withhold or account
for as a result of your participation in the Plan that cannot be satisfied by the means previously described. The Company has no obligation to deliver shares of Common
Stock or proceeds from the sale of such shares of Common Stock to you until you have satisfied the obligations in connection with the Tax-Related Items as described in
this Section.
13. UNSECURED OBLIGATION. Your Award is unfunded, and as the holder of your Award you shall be considered an unsecured creditor of the Company with respect to
the Company’s obligation, if any, to issue shares of Common Stock or other property pursuant to this Agreement. You shall not have voting or any other rights as a
stockholder of the Company with respect to the shares of Common Stock issuable in respect of the Restricted Stock Units. Upon and following the settlement of the
Restricted Stock Units, you shall be the record owner of the shares of Common Stock underlying the Restricted Stock Units unless and until such shares are sold or
otherwise disposed of, and as record owner you shall be entitled to all rights of a stockholder of the Company (including voting rights). Nothing contained in this
Agreement, and no action taken pursuant to its provisions, shall create or be construed to create a trust of any kind or a fiduciary relationship between you and the
Company or any other person.
14. NOTICES. Any notices provided for in your Award, this Agreement or the Plan shall be given in writing and shall be deemed effectively given upon receipt or, in the case
of notices delivered by mail by the Company to you, five days after deposit in the United States mail, postage prepaid, addressed to you at the last address you provided
to the Company. Notwithstanding the foregoing, the Company may, in its sole discretion, decide to deliver any documents related to participation in the Plan and your
Award by electronic means or to request your consent to participate in the Plan by electronic means. You hereby consent to receive such documents by electronic
delivery and, if requested, to agree to participate in the Plan through an on-line or electronic system established and maintained by the Company or another third party
designated by the Company.
15. APPLICABILITY OF THE PLAN. Your Award and this Agreement are subject to all of the provisions of the Plan, the provisions of which are hereby made a part of your
Award and are further subject to all interpretations and amendments of the Plan which may from time to time be promulgated and adopted pursuant to the Plan. In the
event of any conflict between the provisions of this Agreement and those of the Plan, the provisions of the Plan shall control.
16. SEVERABILITY. If all or any part of this Agreement or the Plan is declared by any court or governmental authority to be unlawful or invalid, such unlawfulness or
invalidity shall not invalidate any portion of this Agreement or the Plan not declared to be unlawful or invalid. Any Section of this Agreement or the Plan (or part of such a
Section) so declared to be unlawful or invalid shall, if possible, be construed in a manner which will give effect to the terms of such Section or part of a Section to the
fullest extent possible while remaining lawful and valid.
17. EFFECT ON OTHER EMPLOYEE BENEFIT PLANS. The value of your Award subject to this Agreement shall not be included as compensation, earnings, salaries or
other similar terms used when calculating your benefits under any employee benefit plan sponsored by the Company or any affiliate, except as such plan otherwise
expressly provides. The Company expressly reserves its right to amend, modify or terminate any of the Company’s or any affiliate’s employee benefit plans.
18. AMENDMENT. This Agreement may not be modified or amended except by an instrument in writing, signed by a duly authorized representative of the Company,
provided that no such amendment materially adversely affecting your rights hereunder may be made without your written consent. However, the Board reserves the right
to change, by written notice to you, the provisions of this Agreement in any way it may deem necessary or advisable to carry out the purpose of the Award as a result of
any change in applicable laws or regulations or any future law, regulation, ruling or judicial decision, provided that any such change shall be applicable only to rights
relating to that portion of your Award which is then subject to restrictions as provided herein.
19. COMPLIANCE WITH SECTION 409A OF THE CODE. Your Award is intended to be exempt from the application of Section 409A of the Code, including but not limited
to, by reason of complying with the "short-term deferral” rule set forth in Treasury Regulation Section 1.409A-1(b)(4) and any ambiguities herein shall be interpreted
accordingly. Notwithstanding the foregoing, if it is determined that your Award fails to satisfy the requirements of the short-term deferral rule and is otherwise not exempt
from and determined to be deferred compensation subject to Section 409A of the Code, your Award shall comply with Section 409A to the extent necessary to avoid
adverse personal tax consequences and any ambiguities herein shall be interpreted accordingly. If it is determined that your Award is deferred compensation subject to
Section 409A and you are a "specified employee” (within the meaning set forth in Section 409A(a)(2)(B)(i) of the Code) as of the date of your "separation from service” (as
defined in Section 409A), then the issuance of any shares of Common Stock that would otherwise be made upon the date of your separation from service or within the first
six months thereafter shall not be made on the originally scheduled date and shall instead be issued in a lump sum on the date that is six months and one day after the date
of the separation from service, with the balance of such shares issued thereafter in accordance with the original vesting and issuance schedule set forth above, but if and
only if such delay in the issuance of such shares is necessary to avoid the imposition of adverse taxation on you in respect of such shares under Section 409A of the
Code. Each installment of shares of Common Stock that vests is intended to constitute a "separate payment” for purposes of Treasury Regulation Section 1.409A-2(b)(2).
20. AWARD SUBJECT TO COMPANY CLAWBACK OR RECOUPMENT . To the extent permitted by applicable law, the Restricted Stock Units or any Common Stock
issued in settlement thereof will be subject to clawback or recoupment pursuant to any compensation clawback or recoupment policy adopted by the Board or required by
law during the term of your service with the Company or its affiliates.
21. MISCELLANEOUS.
(a) The Company may assign any of its rights under the Grant Notice, this Agreement and the Plan to one or more assignees, and all covenants contained in the
Grant Notice, this Agreement and the Plan shall inure to the benefit of, and be enforceable by, the Company’s successors and assigns. All obligations of the
Company under the Grant Notice, this Agreement and the Plan shall be binding on any successor to the Company, whether the existence of such successor is
the result of a direct or indirect purchase, merger, consolidation or otherwise, of all or substantially all of the business and/or assets of the Company. Your rights
and obligations under your Award may only be assigned with the prior written consent of the Company.
(b) You agree upon request to execute any further documents or instruments necessary or desirable in the sole determination of the Company to carry out the
purposes or intent of your Award.
(c) You acknowledge and agree that you have reviewed this Agreement, the Grant Notice and the Plan in their entirety, have had an opportunity to obtain the advice
of counsel prior to executing and accepting your Award, and fully understand all provisions of your Award.
(d) This Agreement shall be subject to all applicable laws, rules and regulations, and to such approvals by any governmental agencies or national securities
exchanges as may be required.
ATTACHMENT II
2021 EQUITY INCENTIVE PLAN
Exhibit 21.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Exhibit 23.1
We consent to the incorporation by reference in Registration Statements No. 333-258755 and 333-231712 on Form S-8, and Registration Statement No. 333-273829 on Form S-3 of
Dyadic International, Inc. of our report dated March 28, 2024, on the consolidated balance sheet of Dyadic International, Inc. as of December 31, 2023, and the consolidated
statement of operations, stockholders’ equity and cash flows for the year ended, appearing in this Annual Report on Form 10-K.
Livingston, New Jersey
March 28, 2024
/s/ Crowe LLP
Consent of Independent Registered Public Accounting Firm
Exhibit 23.2
We consent to the incorporation by reference in the Registration Statements on Form S-3 (File No. 333-273829) and Form S-8 (File No. 333-258755 and 231712) of our report dated
March 29, 2023, with respect to the consolidated financial statements of Dyadic International, Inc. and Subsidiaries as of and for the year ended December 31, 2022, included in this
annual report on Form 10-K.
/s/ Mayer Hoffman McCann P.C.
St. Petersburg, Florida
March 28, 2024
Certification of Principal Executive Officer
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
and Securities and Exchange Commission Release 34-46427
Exhibit 31.1
I, Mark A. Emalfarb, certify that:
1.
I have reviewed this annual report on Form 10-K of Dyadic International Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light
of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition,
results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-
15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and we have:
a.
b.
c.
d.
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;
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally
accepted accounting principles;
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
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; and
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.
b.
Date:
By:
Name:
Title:
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
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.
March 28, 2024
/s/ Mark A. Emalfarb
Mark A. Emalfarb
Chief Executive Officer
Certification of Principal Executive Officer
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
and Securities and Exchange Commission Release 34-46427
Exhibit 31.2
I, Ping W. Rawson, certify that:
1.
I have reviewed this annual report on Form 10-K of Dyadic International Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light
of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition,
results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-
15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and we have:
a.
b.
c.
d.
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;
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally
accepted accounting principles;
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
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; and
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.
b.
Date:
By:
Name:
Title:
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
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.
March 28, 2024
/s/ Ping W. Rawson
Ping W. Rawson
Chief Financial Officer
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 32.1
In connection with the Annual Report of Dyadic International Inc. (the "Company") on Form 10-K for the year ended December 31, 2023 as filed with the Securities and Exchange
Commission on the date hereof (the "Report"), I, Mark A. Emalfarb, certify, pursuant to 18 U.S.C. ss. 1350, as adopted pursuant to ss. 906 of the Sarbanes-Oxley Act of 2002, that to
my knowledge:
(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date:
By:
Name:
Title:
March 28, 2024
/s/ Mark A. Emalfarb
Mark A. Emalfarb
Chief Executive Officer
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 32.2
In connection with the Annual Report of Dyadic International Inc. (the "Company") on Form 10-K for the year ended December 31, 2023 as filed with the Securities and Exchange
Commission on the date hereof (the "Report"), I, Ping W. Rawson, certify, pursuant to 18 U.S.C. ss. 1350, as adopted pursuant to ss. 906 of the Sarbanes-Oxley Act of 2002, that to
my knowledge:
(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date:
By:
Name:
Title:
March 28, 2024
/s/ Ping W. Rawson
Ping W. Rawson
Chief Financial Officer
Dyadic International, Inc
POLICY FOR THE
RECOVERY OF ERRONEOUSLY AWARDED COMPENSATION
Exhibit 97
A.
OVERVIEW
In accordance with the applicable rules of The Nasdaq Stock Market (the "Nasdaq Rules”), Section 10D and Rule 10D-1 of the Securities Exchange Act of 1934, as
amended (the "Exchange Act”) ("Rule 10D-1”), the Board of Directors (the "Board”) of Dyadic International, Inc. (the "Company”) has adopted this Policy (the "Policy”) to
provide for the recovery of erroneously awarded Incentive-based Compensation from Executive Officers. All capitalized terms used and not otherwise defined herein shall have the
meanings set forth in Section H, below.
B.
RECOVERY OF ERRONEOUSLY AWARDED COMPENSATION
(1) In the event of an Accounting Restatement, the Company will reasonably promptly recover the Erroneously Awarded Compensation Received in accordance with
Nasdaq Rules and Rule 10D-1 as follows:
(i)
After an Accounting Restatement, the Compensation Committee (if composed entirely of independent directors, or in the absence of such a committee, a majority
of independent directors serving on the Board) (the "Committee”) shall determine the amount of any Erroneously Awarded Compensation Received by each
Executive Officer and shall promptly notify each Executive Officer with a written notice containing the amount of any Erroneously Awarded Compensation and a
demand for repayment or return of such compensation, as applicable.
(a)
For Incentive-based Compensation based on (or derived from) the Company’s stock price or total shareholder return, where the amount of Erroneously
Awarded Compensation is not subject to mathematical recalculation directly from the information in the applicable Accounting Restatement:
i.
ii.
The amount to be repaid or returned shall be determined by the Committee based on a reasonable estimate of the effect of the Accounting
Restatement on the Company’s stock price or total shareholder return upon which the Incentive-based Compensation was Received; and
The Company shall maintain documentation of the determination of such reasonable estimate and provide the relevant documentation as
required to the Nasdaq.
(ii)
The Committee shall have discretion to determine the appropriate means of recovering Erroneously Awarded Compensation based on the particular facts and
circumstances. Notwithstanding the foregoing, except as set forth in Section B(2) below, in no event may the Company accept an amount that is less than the
amount of Erroneously Awarded Compensation in satisfaction of an Executive Officer’s obligations hereunder.
(iii)
(iv)
To the extent that the Executive Officer has already reimbursed the Company for any Erroneously Awarded Compensation Received under any duplicative
recovery obligations established by the Company or applicable law, it shall be appropriate for any such reimbursed amount to be credited to the amount of
Erroneously Awarded Compensation that is subject to recovery under this Policy.
To the extent that an Executive Officer fails to repay all Erroneously Awarded Compensation to the Company when due, the Company shall take all actions
reasonable and appropriate to recover such Erroneously Awarded Compensation from the applicable Executive Officer. The applicable Executive Officer shall be
required to reimburse the Company for any and all expenses reasonably incurred (including legal fees) by the Company in recovering such Erroneously Awarded
Compensation in accordance with the immediately preceding sentence.
(2) Notwithstanding anything herein to the contrary, the Company shall not be required to take the actions contemplated by Section B(1) above if the Committee
(which, as specified above, is composed entirely of independent directors or in the absence of such a committee, a majority of the independent directors serving on the Board)
determines that recovery would be impracticable and any of the following [two][three] conditions are met:
(i)
(ii)
The Committee has determined that the direct expenses paid to a third party to assist in enforcing the Policy would exceed the amount to be recovered. Before
making this determination, the Company must make a reasonable attempt to recover the Erroneously Awarded Compensation, documented such attempt(s) and
provided such documentation to the Nasdaq;
or
Recovery would likely cause an otherwise tax-qualified retirement plan, under which benefits are broadly available to employees of the Company, to fail to meet
the requirements of Section 401(a)(13) or Section 411(a) of the Internal Revenue Code of 1986, as amended, and regulations thereunder.
C.
DISCLOSURE REQUIREMENTS
The Company shall file all disclosures with respect to this Policy required by applicable U.S. Securities and Exchange Commission ("SEC”) filings and rules.
D.
PROHIBITION OF INDEMNIFICATION
The Company shall not be permitted to insure or indemnify any Executive Officer against (i) the loss of any Erroneously Awarded Compensation that is repaid, returned or
recovered pursuant to the terms of this Policy, or (ii) any claims relating to the Company’s enforcement of its rights under this Policy. Further, the Company shall not enter into
any agreement that exempts any Incentive-based Compensation that is granted, paid or awarded to an Executive Officer from the application of this Policy or that waives the
Company’s right to recovery of any Erroneously Awarded Compensation, and this Policy shall supersede any such agreement (whether entered into before, on or after the
Effective Date of this Policy).
E.
ADMINISTRATION AND INTERPRETATION
This Policy shall be administered by the Committee, and any determinations made by the Committee shall be final and binding on all affected individuals.
The Committee is authorized to interpret and construe this Policy and to make all determinations necessary, appropriate, or advisable for the administration of this Policy
and for the Company’s compliance with Nasdaq Rules, Section 10D, Rule 10D-1 and any other applicable law, regulation, rule or interpretation of the SEC or Nasdaq promulgated
or issued in connection therewith.
F.
AMENDMENT; TERMINATION
The Committee may amend this Policy from time to time in its discretion and shall amend this Policy as it deems necessary. Notwithstanding anything in this Section F to
the contrary, no amendment or termination of this Policy shall be effective if such amendment or termination would (after taking into account any actions taken by the Company
contemporaneously with such amendment or termination) cause the Company to violate any federal securities laws, SEC rule or Nasdaq rule.
G.
OTHER RECOVERY RIGHTS
This Policy shall be binding and enforceable against all Executive Officers and, to the extent required by applicable law or guidance from the SEC or Nasdaq, their
beneficiaries, heirs, executors, administrators or other legal representatives. The Committee intends that this Policy will be applied to the fullest extent required by applicable law.
Any employment agreement, equity award agreement, compensatory plan or any other agreement or arrangement with an Executive Officer shall be deemed to include, as a
condition to the grant of any benefit thereunder, an agreement by the Executive Officer to abide by the terms of this Policy. Any right of recovery under this Policy is in addition to,
and not in lieu of, any other remedies or rights of recovery that may be available to the Company under applicable law, regulation or rule or pursuant to the terms of any policy of
the Company or any provision in any employment agreement, equity award agreement, compensatory plan, agreement or other arrangement.
H.
DEFINITIONS
For purposes of this Policy, the following capitalized terms shall have the meanings set forth below.
(1) "Accounting Restatement” means an accounting restatement due to the material noncompliance of the Company with any financial reporting requirement under
the securities laws, including any required accounting restatement to correct an error in previously issued financial statements that is material to the previously issued financial
statements (a "Big R” restatement), or that would result in a material misstatement if the error were corrected in the current period or left uncorrected in the current period (a "little r”
restatement).
(2) "Clawback Eligible Incentive Compensation” means all Incentive-based Compensation Received by an Executive Officer (i) on or after the effective date of the
applicable Nasdaq rules, (ii) after beginning service as an Executive Officer, (iii) who served as an Executive Officer at any time during the applicable performance period relating to
any Incentive-based Compensation (whether or not such Executive Officer is serving at the time the Erroneously Awarded Compensation is required to be repaid to the Company),
(iv) while the Company has a class of securities listed on a national securities exchange or a national securities association, and (v) during the applicable Clawback Period (as
defined below).
(3) "Clawback Period” means, with respect to any Accounting Restatement, the three completed fiscal years of the Company immediately preceding the
Restatement Date (as defined below), and if the Company changes its fiscal year, any transition period of less than nine months within or immediately following those three
completed fiscal years.
(4) "Erroneously Awarded Compensation” means, with respect to each Executive Officer in connection with an Accounting Restatement, the amount of Clawback
Eligible Incentive Compensation that exceeds the amount of Incentive-based Compensation that otherwise would have been Received had it been determined based on the
restated amounts, computed without regard to any taxes paid.
(5) "Executive Officer” means each individual who is currently or was previously designated as an "officer” of the Company as defined in Rule 16a-1(f) under the
Exchange Act. For the avoidance of doubt, the identification of an executive officer for purposes of this Policy shall include each executive officer who is or was identified pursuant
to Item 401(b) of Regulation S-K or Item 6.A of Form 20-F, as applicable, as well as the principal financial officer and principal accounting officer (or, if there is no principal
accounting officer, the controller).
(6) "Financial Reporting Measures” means measures that are determined and presented in accordance with the accounting principles used in preparing the
Company’s financial statements, and all other measures that are derived wholly or in part from such measures. Stock price and total shareholder return (and any measures that are
derived wholly or in part from stock price or total shareholder return) shall, for purposes of this Policy, be considered Financial Reporting Measures. For the avoidance of doubt, a
Financial Reporting Measure need not be presented in the Company’s financial statements or included in a filing with the SEC.
(7) "Incentive-based Compensation” means any compensation that is granted, earned or vested based wholly or in part upon the attainment of a Financial
Reporting Measure.
(8) "Nasdaq” means The Nasdaq Stock Market.
(9) "Received” means, with respect to any Incentive-based Compensation, actual or deemed receipt, and Incentive-based Compensation shall be deemed received in
the Company’s fiscal period during which the Financial Reporting Measure specified in the Incentive-based Compensation award is attained, even if the payment or grant of the
Incentive-based Compensation to the Executive Officer occurs after the end of that period.
(10) "Restatement Date” means the earlier to occur of (i) the date the Board, a committee of the Board or the officers of the Company authorized to take such action if
Board action is not required, concludes, or reasonably should have concluded, that the Company is required to prepare an Accounting Restatement, or (ii) the date a court,
regulator or other legally authorized body directs the Company to prepare an Accounting Restatement.
Effective as of November 30, 2023.