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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
     
 
FORM 8-K
     
 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
 
Date of Report (date of earliest event reported): March 26, 2024
     
 
Dyadic International, Inc.
(Exact name of registrant as specified in its charter)
     
 
     
Delaware
(State or other jurisdiction of incorporation or organization)
000-55264
(Commission File Number)
45-0486747
(I.R.S. Employer Identification Number)
     
1044 North U.S. Highway One, Suite 201
Jupiter, FL 33477
(Address of principal executive offices and zip code)
 
(561) 743-8333
(Registrant’s telephone number, including area code)
 
N/A
 (Former Name or Former Address, if Changed Since Last Report)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Securities registered pursuant to Section 12(b) of the Act
 
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, par value $0.001 per share
DYAI
The NASDAQ Stock Market LLC
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
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. ☐
 






 
Item 2.02. Results of Operations and Financial Condition
 
On March 28, 2024, Dyadic International, Inc. (“Dyadic”, or the “Company”) issued a press release announcing its financial results for the year ended December 31, 2023 and recent Company progress. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference into this Item 2.02.
 
The information in this Item 2.02, including the information set forth in Exhibit 99.1, is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of such section. Such information shall not be incorporated by reference in any filing under the Securities Act of 1933 (the “Securities Act”), as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
 
Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. 
 
(b)
 
On March 26, 2024, the board of directors (the “Board”) of the Company appointed current member of the Board Patrick Lucy as its Chairman, succeeding the current Chairman Michael Tarnok, effective immediately Also on March 26, 2024, Mr. Tarnok notified the Board of his decision to retire as a director of the Board, effective at the Company’s annual meeting to be held in June 2025. Mr. Tarnok intends to continue to serve as a director until such date. Mr. Tarnok’s decision to retire was not due to any disagreement with the Company on any matter relating to the Company’s operations, policies or practices.
 
Also on March 26, 2024, Dr. Barry C. Buckland notified the Board of his decision to retire as a director of the Board, effective at the Company’s annual meeting to be held in June 2024. Dr. Buckland’s decision to retire was not due to any disagreement with the Company on any matter relating to the Company’s operations, policies or practices.
 
(c)
 
Also on March 26, 2024, the Board appointed Joseph Hazelton, its current Chief Business Officer, to the position of Chief Operating Officer, effective immediately. For the biography of Mr. Hazelton, age 48, see “Our Executive Officers” in the Company’s definitive proxy statement on Schedule 14A, filed with the Securities and Exchange Commission on April 26, 2023.  There are no transactions involving Mr. Hazelton required to be disclosed under Item 404 of Regulation S-K. To the extent the Company enters into a material compensatory arrangement, or materially amends an existing compensatory arrangement, with Mr. Hazelton in connection with this appointment, the Company will make the required public disclosure with the Securities and Exchange Commission.
 
Item 7.01. Regulation FD Disclosure.
 
On March 28, 2024, the Company issued a press release announcing the aforementioned changes in board and management leadership roles. A copy of the press release is furnished herewith as Exhibit 99.2 and is incorporated herein by reference.
 
The information in this Item 7.01, including the information set forth in Exhibit 99.2, is furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of such section. Such information shall not be incorporated by reference into any filing under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
 
Item 9.01. Financial Statements and Exhibits
 
 
(d) Exhibits
 
   
Exhibit
Number
Description
 
     
99.1
 
99.2 Dyadic announces change in board and management leadership roles press release dated March 28, 2024  
104 Cover page Interactive Data File (embedded within the Inline XBRL document)  
 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
Date: March 28, 2024
 
 
Dyadic International, Inc.
     
 
By:
/s/ Mark A. Emalfarb
 
Name:
Mark A. Emalfarb
 
Title:
Chief Executive Officer
 
 
EX-99.1 2 ex_599795.htm EXHIBIT 99.1 ex_599795.htm

Exhibit 99.1

 

 

 

dyadic.jpg

 

DYADIC REPORTS 2023 FULL YEAR RESULTS AND RECENT COMPANY PROGRESS

 

 

Closed a $6.0 million convertible note in a private placement, with a conversion price of $1.79 and no warrants

 

Reported positive topline data from First-In-Human Phase 1 trial demonstrated clinical safety and antibody response for DYAI-100 a recombinant protein receptor binding domain (RBD) booster vaccine candidate for protection against COVID-19 infection

 

Entered into several fully funded vaccine and antibody projects covering more than twelve targets since announcing topline clinical safety data from First-In-Human Phase 1 trial

 

Executed a term sheet to utilize our microbial protein production platforms to develop production strains for the production of recombinant serum albumin initially for diagnostic and cell culture applications

 

Announced strategic partnership to develop affordable rabies prophylactics and vaccines using C1-cell protein production platform

 

Advanced collaboration with Israel Institute for Biological Research (IIBR) targeting bio-threats and emerging disease solutions

 

Announced a partnership with Cygnus Technologies to develop and supply a C1 Host Cell Protein ELISA Assay Kit to support batch release testing for C1-based products

 

Reported multiple new research and license agreements with Massachusetts General Hospital, bYoRNA (for mRNA), and others  

 

Expanded collaboration with Phibro/Abic to develop vaccines and treatments for companion and livestock animal diseases

 

Published manuscript of preclinical studies on C1 produced monoclonal antibody in non-human primate and hamsters in prestigious peer-reviewed journal Nature Communications

 

Cash and investment grade securities of $13.3m, including the $6.0 million convertible note financing

 

Changes in board and management leadership roles have been reported in a separate press release this morning

 

Financial results and business update conference call scheduled for 5:00 pm ET today

 

JUPITER, FL / March 28, 2024 (GLOBAL NEWSWIRE) Dyadic International, Inc. (“Dyadic”, “we”, “us”, “our”, or the “Company”) (NASDAQ: DYAI), a biotechnology company focused on the efficient large-scale manufacture of proteins for use in human and animal vaccines and therapeutics and for use in non-pharmaceutical applications including food, nutrition, and wellness, today announced its financial results for the year end 2023 and highlighted recent Company progress.

 

“In 2023, Dyadic achieved significant milestones in unlocking the potential of its microbial platforms. One of the highlights was the successful completion of a Phase 1 clinical trial, with positive topline data affirming the safety of Dyadic’s C1 platform in humans,” said Mark Emalfarb, Dyadic’s President and Chief Executive Officer. “We believe this milestone not only establishes the safety of our platform but also lays a solid foundation for C1 technology’s future applications in human and animal vaccines and therapeutics. Additionally, our progress made across pharmaceutical and non-pharmaceutical market segments, including human health, animal health, and alternative proteins, underscores Dyadic’s commitment to innovation and its ability to address diverse areas of need within the biotechnology and food industries. We are grateful for the collaborative efforts of our partners and the dedication of our management team and staff providing invaluable contributions to Dyadic’s success. Dyadic’s achievements in 2023 reflect our commitment to advancing our microbial platforms for various applications and its dedication to improving human and animal health while also addressing the challenges of sustainable food production.”

 

Mr. Emalfarb continued, “As we move forward into 2024, our company remains committed to advancing the Dapibus™ platform, specifically tailored for non-pharmaceutical applications in sectors including food, nutrition, health, and wellness. To achieve this objective, we have refined our business development strategies, concentrating on core areas where our technologies can make the most significant impact in the shortest amount of time. This approach involves targeting multiple core verticals simultaneously and exploring new opportunities that align with our overall strategy.”

 

“In addition to operational advancements, we also strengthened our financial position with the issuance of $6.0 million in convertible notes which will be used to accelerate and exploit our strategic objective of near-term revenue generating products and opportunities for pharmaceutical and non-pharmaceutical applications. We believe that we are well-positioned, both financially and scientifically, to execute our strategic plan with enhanced capabilities and resources. We are excited about the prospects ahead and remain dedicated to delivering value to our customers and stakeholders.” Mr. Emalfarb concluded.

 

Dyadic is committed to empowering its partners and collaborators in the development of effective antigens, antibodies and other therapeutic proteins for the prevention, diagnosis, and treatments worldwide. Through an enhanced global outreach strategy, Dyadic is actively advancing its proprietary microbial platform technology to develop products such as recombinant human and bovine albumin, alongside biologic vaccines, antibodies, and other biopharmaceutical solutions. By building a robust pipeline of opportunities, Dyadic believes it can significantly impact global health, fostering a brighter and healthier future through innovation and strategic collaboration.

 

Recent Company Progress

 

Corporate 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.

 

The Company announced changes in the leadership roles of the Board and senior management team. Details of these changes are included in a separate press release issued this morning, March 28, 2024.

 

 

Exhibit 99.1

 

DYAI-100 Phase 1 Clinical Trial

 

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 has 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.

 

Biopharmaceutical Programs

 

 

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 prestigious peer-reviewed journal Nature Communications. A non-human primate challenge study completed dosing of a C1 produced COVID-19 monoclonal antibody (mAb) 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 of approximately Є1.7 million 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.

 

 

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 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 a US $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.

 

 

Exhibit 99.1

 

Non-pharmaceutical Programs

 

Dyadic is advancing a pipeline of differentiated product candidates that leverage its microbial protein production platforms, including Dapibus™ which have demonstrated the ability and efficiency to enable the rapid development and large-scale manufacture of proteins at low cost in a wide range of non-pharmaceutical applications and commercial use.

 

 

Cell Culture Media Products

 

o

Recombinant Serum Albumin: In March 2024, the Company executed a term sheet with a large 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.

 

o

In March 2024, the Company entered into a co-promotion agreement with Biftek Co. for the promotion of growth media supplement for cell culture.

 

o

The Company is undergoing a project to produce recombinant transferrin for use in cell culture media for the alternative protein industry, and initial expression in our microbial platform was successful.

 

o

The Company is currently sampling recombinant bovine albumin for application testing as growth media for the cultured meat industry.

 

 

Non-animal Dairy Products

 

o

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.

 

o

The Company has developed a highly productive strain and is actively sampling recombinant alpha-lactalbumin, a whey protein, with interested collaborators.

 

o

The Company has initiated a beta-lactoglobulin animal-free recombinant whey protein project in early 2024.

 

o

The Company is undergoing a recombinant lactoferrin project, expected to begin sampling the product in the late second or early third quarter of 2024.

 

o

The Company has expressed 4 casein proteins and is in active discussions with potential interested collaborators.

 

 

Bio Industrial Products

 

o

The Company has developed a number of enzymes that have the potential for use in multiple industries, such as nutrition, biofuels and biorefining.

 

Financial Highlights

 

Cash Position: As of December 31, 2023, cash, cash equivalents, and the carrying value of investment-grade securities, including accrued interest, were approximately $7.3 million compared to $12.7 million on December 31, 2022. For the year ended December 31, 2023, the Company received a total of approximately $1.3 million in connection with the sale of Alphazyme LLC. On March 8, 2024, the Company raised $6.0 million in a private placement of convertible notes from existing shareholders.

 

Revenue: Total revenue for the year ended December 31, 2023, decreased to approximately $2,899,000 compared to $2,930,000 for the year ended December 31, 2022. The decrease in revenue was due to higher individual contract amounts on certain research funding during 2022.

 

Cost of Revenue: Cost of research and development revenue for the year ended December 31, 2023, decreased to approximately $1,976,000 compared to $2,123,000 for the year ended December 31, 2022. The decrease in cost of revenue was due to higher individual contract amounts on certain research funding during 2022.

 

R&D Expenses: Research and development expenses for the year ended December 31, 2023, decreased to approximately $3,297,000 compared to $4,501,000 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.

 

G&A Expenses: General and administrative expenses for the year ended December 31, 2023, decreased to approximately $5,817,000 compared to $6,422,000 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 in insurance premiums of $96,000, and other increases of $24,000.

 

Interest Income: Interest income for the year ended December 31, 2023, increased to approximately $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 $1,018,000 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.

 

Net Loss: Net loss for the year ended December 31, 2023, was approximately $6.8 million, or $(0.24) per share, compared to a net loss of $9.7 million, or $(0.34) per share, for the year ended December 31, 2022.

 

 

Exhibit 99.1

 

Conference Call Information

 

Date: Thursday, March 28, 2024 Time: 5:00 p.m. Eastern Time

Dial-in numbers: Toll Free: 877-407-0784 International: 201-689-8560

Conference ID: 13743567

 

Webcast Link: https://viavid.webcasts.com/starthere.jsp?ei=1650830&tp_key=065a3e040c

 

An archive of the webcast will be available within 24 hours after completion of the live event and will be accessible on the Investor Relations section of the Company’s website at www.dyadic.com. To access the replay of the webcast, please follow the webcast link above.

 

About Dyadic International, Inc.

 

Dyadic International, Inc. is a biotechnology company focused on the efficient large-scale manufacture of proteins for use in human and animal vaccines and therapeutics and for use in non-pharmaceutical applications including food, nutrition, and wellness.

 

Dyadic’s gene expression and protein production platforms are based on the highly productive and scalable fungus Thermothelomyces heterothallica (formerly Myceliophthora thermophila). Our lead technology, C1-cell protein production platform, is based on an industrially proven microorganism (named C1), which is currently used to speed development, lower production costs, and improve performance of biologic vaccines and drugs at flexible commercial scales for the human and animal health markets. Dyadic has also developed the DapibusTM 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.

 

With a passion to enable our partners and collaborators to develop effective preventative and therapeutic treatments in both developed and emerging countries, Dyadic is building an active pipeline by advancing its proprietary microbial platform technologies, including our lead asset DYAI-100 COVID-19 vaccine candidate, as well as other biologic vaccines, antibodies, and other biological products.

 

To learn more about Dyadic, please visit http://www.dyadic.com.

 

Safe Harbor Regarding Forward-Looking Statements

 

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act, including those regarding Dyadic International’s expectations, intentions, strategies, and beliefs pertaining to future events or future financial performance, such as the success of our clinical trial and interest in our protein production platforms, our research projects and third-party collaborations, as well as the availability of necessary funding. 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. Forward-looking statements involve many risks, uncertainties or other factors beyond Dyadic’s control. These factors include, but are not limited to, the following: (i) our history of net losses; (ii) market and regulatory acceptance of our microbial protein production platforms and other technologies; (iii) competition, including from alternative technologies; (iv) the results of nonclinical studies and clinical trials; (v) our capital needs; (vi) changes in global economic and financial conditions; (vii) our reliance on information technology; (viii) our dependence on third parties; (ix) government regulations and environmental, social and governance issues; and (x) intellectual property risks.

 

For a more complete description of the risks that could cause our actual results to differ from our current expectations, please see the section entitled “Risk Factors” in Dyadic’s annual reports on Form 10-K and quarterly reports on Form 10-Q filed with the SEC, as such factors may be updated from time to time in Dyadic’s periodic filings with the SEC, which are accessible on the SEC’s website and at www.dyadic.com. All forward-looking statements speak only as of the date made, and except as required by applicable law, Dyadic assumes no obligation to publicly update any such forward-looking statements for any reason after the date of this press release to conform these statements to actual results or to changes in our expectations.

 

Contact:

 

Dyadic International, Inc.

Ping W. Rawson

Chief Financial Officer Phone: (561) 743-8333

Email: ir@dyadic.com

 

 

Exhibit 99.1

 

DYADIC INTERNATIONAL, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

 

   

Years Ended December 31,

 
   

2023

   

2022

 

Revenues:

               

Research and development revenue

  $ 2,545,865     $ 2,683,244  

License revenue

    352,941       247,059  

Total revenue

    2,898,806       2,930,303  
                 

Costs and expenses:

               

Costs of research and development revenue

    1,975,849       2,123,193  

Research and development

    3,297,266       4,501,365  

General and administrative

    5,817,013       6,421,505  

Foreign currency exchange loss

    38,417       49,918  

Total costs and expenses

    11,128,545       13,095,981  
                 

Loss from operations

    (8,229,739 )     (10,165,678 )
                 

Other income:

               

Interest income

    416,686       180,420  

Gain on sale of Alphazyme

    1,017,592        

Other income

          250,000  

Total other income

    1,434,278       430,420  
                 

Net loss

  $ (6,795,461 )   $ (9,735,258 )
                 

Basic and diluted net loss per common share

  $ (0.24 )   $ (0.34 )
                 

Basic and diluted weighted-average common shares outstanding

    28,798,833       28,364,482  

 

See Notes to Consolidated Financial Statements in Dyadic’s Annual Report on Form 10-K filed with Securities and Exchange Commission on March 28, 2024.

 

 

Exhibit 99.1

 

DYADIC INTERNATIONAL, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

 

   

December 31,

 
   

2023

   

2022

 

Assets

               

Current assets:

               

Cash and cash equivalents

  $ 6,515,028     $ 5,794,272  

Short-term investment securities

    748,290       6,847,270  

Interest receivable

    10,083       58,285  

Accounts receivable

    466,159       330,001  

Prepaid expenses and other current assets

    327,775       392,236  

Total current assets

    8,067,335       13,422,064  
                 

Non-current assets:

               

Operating lease right-of-use asset, net

    141,439        

Investment in Alphazyme

          284,709  

Other assets

    10,462       6,045  

Total assets

  $ 8,219,236     $ 13,712,818  
                 

Liabilities and stockholders’ equity

               

Current liabilities:

               

Accounts payable

  $ 656,445     $ 1,276,313  

Accrued expenses

    1,057,164       955,081  

Deferred research and development obligations

    490,113       40,743  

Deferred license revenue, current portion

          176,471  

Operating lease liability, current portion

    48,059        

Total current liabilities

    2,251,781       2,448,608  
                 

Deferred license revenue, net of current portion

          176,471  

Operating lease liability, net of current portion

    88,870        

Total liabilities

    2,340,651       2,625,079  
                 

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

    41,065       40,817  

Additional paid-in capital

    105,044,756       103,458,697  

Treasury stock, shares held at cost - 12,253,502

    (18,929,915 )     (18,929,915 )

Accumulated deficit

    (80,277,321 )     (73,481,860 )

Total stockholders’ equity

    5,878,585       11,087,739  

Total liabilities and stockholders’ equity

  $ 8,219,236     $ 13,712,818  

 

See Notes to Consolidated Financial Statements in Dyadic’s Annual Report on Form 10-K filed with Securities and Exchange Commission on March 28, 2024.

 

 
EX-99.2 3 ex_646031.htm EXHIBIT 99.2 ex_646031.htm

Exhibit 99.2

 

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Dyadic Announces Change in Board and Management Leadership Roles

 

JUPITER, FL – March 28, 2024 (GLOBE NEWSWIRE) – Dyadic International, Inc. (“Dyadic”, “we”, “us”, “our”, or the “Company”) (NASDAQ: DYAI), a biotechnology company focused on the efficient large-scale manufacture of proteins for use in human and animal vaccines and therapeutics and for use in non-pharmaceutical applications including food, nutrition, and wellness, today announced that Michael Tarnok is stepping down as Chairman of Dyadic’s board of directors (the “Board”) and that current member of the Board Patrick Lucy has been appointed to succeed him, in each case, effective immediately. Mr. Tarnok will continue to serve as a director through the end of his current term, which will end at the Company’s annual meeting in June 2025, at which time he expects to retire. In addition, Dr. Barry Buckland announced that he is retiring and therefore will not stand for re-election at the Company’s annual meeting in June 2024. The Board has decided not to fill the vacancy due to Dr. Buckland’s retirement which will result in a reduction of the size of the Board from seven to six members. Finally, Joseph Hazelton has been appointed Chief Operating Officer, effective immediately, and will oversee the day-to-day operations of the Company.

 

Mr. Lucy joined the Board in January 2021 and has serves on the company’s Science and Technology Committee. He is currently the President and Chief Executive Officer of RoslinCT US, a privately held cell therapy contract development and manufacturing organization based in Hopkinton, Massachusetts and Edinburgh, Scotland. Mr. Lucy has 33 years of experience in the biotechnology industry, including a founder of Pfenex Inc., a protein expression platform technology company that originated within The Dow Chemical Company (“Dow”). He was a member of the leadership team that led the commercial launch of the Pfenex Expression Technology™ platform in 2005 and participated in the spin out of the business from Dow in 2009 via a Series A venture financing. Throughout Pfenex’s history, Mr. Lucy led business/corporate development and portfolio strategy as Chief Business Officer and was a member of the team that successfully completed Pfenex’s initial public offering in 2014. During his tenure at Pfenex, Mr. Lucy completed over $1.5 billion dollars of partnership transactions, and Pfenex was ultimately acquired by Ligand Pharmaceuticals in October 2020 for up to $512 million.

 

"I am excited to assume the role as Chairman of the Dyadic board of directors. On behalf of the entire Dyadic team, I would like to thank Mike Tarnok for his leadership as Chairman over the past ten years,” said Mr. Lucy. “I believe that Dyadic is poised to monetize the many scientific advances we have made with our C1 gene expression system, including the completion of the first Phase 1 clinical study in 2023, and our new Dapibus™ platform that is focused on producing high value proteins for food, nutrition, and wellness. I look forward to working with Mark Emalfarb, our CEO, and Joe Hazelton in his new role as Chief Operating Officer and the rest of our talented management team and Board with a laser focus on maximizing shareholder value.”

 

Mark Emalfarb, Dyadic’s Chief Executive Officer commented, “Patrick has been an outstanding board member over the past three years and I am pleased that he has agreed to take on the role as Board Chairman at a pivotal time for Dyadic. We are accelerating commercialization of the C1 and Dapibus platforms for pharmaceutical and nonpharmaceutical applications. Under Michael Tarnok’s leadership, Dyadic has evolved from the industrial enzyme business and has developed a flexible, safe, and highly efficient platform for the development and production of biologics and we believe we are now poised to deliver impactful advancements that could potentially transform healthcare and food production. I could not be more pleased that Mike has agreed to complete his current term through June 2025, so we can continue to benefit from his expertise and guidance.”

 

Mr. Emalfarb continued, “Barry has been an invaluable member of our Science and Technology Committee and has contributed greatly to the numerous scientific achievements we have accomplished over the last six years. We will miss him and wish him well in his future endeavors.”

 

Mr. Emalfarb concluded, “Joe has been instrumental in refocusing the Company on core verticals with shorter-term revenue opportunities, playing a vital role in achieving strategic objectives. His promotion to Chief Operating Officer is well-deserved, and I'm confident he will further enhance Dyadic’s value by expanding the internal pipeline of high-value biologic products and accelerating the commercialization of assets like alpha-lactalbumin and recombinant human albumin.”

 

“I am very excited to take on these additional responsibilities and have a more active role in overall corporate direction and execution of our strategic business plans to accelerate and exploit short-term revenue producing products and opportunities for pharmaceutical and non-pharmaceutical applications. I look forward to expanding our internal pipeline improving our capability to develop more rapid custom solutions for collaborators and hastening the commercialization of current assets,” said Joe Hazelton, Dyadic’s new Chief Operating Officer.

 

 

About Dyadic International, Inc.

 

Dyadic International, Inc., is a biotechnology company focused on the efficient large-scale manufacture of proteins for use in human and animal vaccines and therapeutics and for use in non-pharmaceutical applications including food, nutrition, and wellness.

 

Dyadic’s gene expression and protein production platforms are based on the highly productive and scalable fungus Thermothelomyces heterothallica (formerly Myceliophthora thermophila). Our lead platform, C1-cell protein production platform, is based on an industrially proven microorganism (named C1), which is currently used to speed development, lower production costs, and potentially improve performance of biologic vaccines and drugs at flexible commercial scales for the human and animal health markets. Dyadic has also developed the DapibusTM 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.

 

Dyadic is focusing on leveraging its microbial platform technologies for itself and its collaborators in a wide range of applications, including human and animal vaccines, therapeutics, food, nutrition, wellness, and internal biological products.

 

To learn more about Dyadic please visit http://www.dyadic.com.

 

 

Safe Harbor Regarding Forward-Looking Statements

 

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including those regarding Dyadic International’s expectations, intentions, strategies, and beliefs pertaining to future events or future financial performance, such as the outcomes of the personnel changes described herein, as well as the success of our protein production platforms. 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. Forward-looking statements involve many risks, uncertainties or other factors beyond Dyadic’s control. These factors include, but are not limited to, the following: (i) our history of net losses; (ii) market and regulatory acceptance of our microbial protein production platforms and other technologies; (iii) competition, including from alternative technologies; (iv) the results of nonclinical studies and clinical trials; (v) our capital needs; (vi) changes in global economic and financial conditions; (vii) our reliance on information technology; (viii) our dependence on third parties; (ix) government regulations and environmental, social and governance issues; and (x) intellectual property risks. For a more complete description of the risks that could cause our actual results to differ from our current expectations, please see the section entitled “Risk Factors” in Dyadic’s annual reports on Form 10-K and quarterly reports on Form 10-Q filed with the Securities and Exchange Commission (“SEC”), as such factors may be updated from time to time in Dyadic’s periodic filings with the SEC, which are accessible on the SEC’s website and at www.dyadic.com. All forward-looking statements speak only as of the date made, and except as required by applicable law, Dyadic assumes no obligation to publicly update any such forward-looking statements for any reason after the date of this press release to conform these statements to actual results or to changes in our expectations.

 

Contact:

Dyadic International, Inc.

Ping W. Rawson

Chief Financial Officer

Phone: (561) 743-8333

Email: ir@dyadic.com