DYAI Dyadic International Inc

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Delaware	000-55264	45-0486747
(State or other jurisdiction of incorporation or organization)	(Commission File Number)	(I.R.S. Employer Identification Number)

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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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

Item 1.01

Entry into a Material Definitive Agreement.

Item 7.01

Regulation FD Disclosure.

Item 9.01

Financial Statements and Exhibits.

Exhibit Number	Description
10.1(1)	Grant Agreement between Dyadic International, Inc. and the Bill & Melinda Gates Foundation, dated as of November 16, 2024
99.1	Dyadic International Press Release Dated November 21, 2024
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

	Dyadic International, Inc.
	By:	/s/ Mark A. Emalfarb
	Name:	Mark A. Emalfarb
	Title:	Chief Executive Officer

Certain identified information in this exhibit has been excluded from the exhibit because it is both not material and is the type that the registrant treats as private or confidential. Information that has been omitted has been noted in this document with a placeholder identified by the mark “[***]”.

 

 

 

 

GRANT AGREEMENT

 

Investment ID [***]

 

AGREEMENT SUMMARY & SIGNATURE PAGE

 

 

GRANTEE INFORMATION
Name:	Dyadic International Inc.
Tax Status:	Not exempt from federal income tax under U.S. IRC § 501(c)(3) You confirm that the above information is correct and agree to notify the Foundation immediately of any change.
Expenditure Responsibility:	This Agreement is subject to "expenditure responsibility" requirements under the U.S. Internal Revenue Code.
Mailing Address:	1044 North US Highway One, Suite 201, Jupiter, FL 33477, USA
Primary Contact:	[***]

 

FOUNDATION INFORMATION
Mailing Address:	[***]
Primary Contact:	[***]

 

AGREEMENT INFORMATION
Title:	Production of mAb in Thermothelomyces heterothallica C1 expression system
“Charitable Purpose":	To produce low-cost monoclonal antibodies to protect vulnerable populations in LMICs from infectious diseases including malaria and RSV
"Start Date":	Date of last signature
"End Date":	August 31, 2026
This Agreement includes and	This Agreement Summary & Signature Page and: [***]
incorporates by this
reference:

 

THIS AGREEMENT is between Dyadic International Inc. ("You" or "Grantee") and the Bill & Melinda Gates Foundation ("Foundation"), and is effective as of date of last signature. Each party to this Agreement may be referred to individually as a "Party" and together as the "Parties." As a condition of this grant, the Parties enter into this Agreement by having their authorized representatives sign below.

 

By:

DYADIC INTERNATIONAL INC.

 

 

Title [***]

 

Date [***]

 

By:

BILL & MELINDA GATES FOUNDATION         

[***]

     Title [***]

Date [***]

 

GRANT AGREEMENT

 

Investment ID [***]

 

ATTACHMENT A

 

GRANT AMOUNT AND REPORTING & PAYMENT SCHEDULE

 

GRANT AMOUNT

 

The Foundation will pay You the total grant amount specified in the Reporting & Payment Schedule below. The Foundation's Primary Contact must approve in writing any Budget cost category change of more than [***].

 

REPORTING & PAYMENT SCHEDULE

 

[***]

 

REPORTING

 

[***]

 

ACCOUNTING FOR PERSONNEL TIME

 

[***]

 

 

REPORTING & PAYMENT SCHEDULE
Investment Period	Target, Milestone, or Reporting Deliverable	Due By	Payment Date	Payment Amount (U.S.$)
	[***]	[***]	[***]	[***]
[***]	[***]	[***]
[***]	[***]	[***]	[***]	[***]
	[***]	[***]
[***]	[***]	[***]

 

 

[***]
[***]	[***]	[***]
[***]	[***]	[***]
[***]	[***]	[***]
[***]	[***]	[***]	[***]	[***]
[***]	[***]	[***]
[***]	[***]	[***]
[***]	[***]	[***]
Total Grant Amount				$3,092,136.00

 

GRANT AGREEMENT

 

Investment ID [***]

 

ATTACHMENT B

 

TERMS & CONDITIONS

 

 

This Agreement is subject to the following terms and conditions.

 

PROJECT SUPPORT         

 

PROJECT DESCRIPTION AND CHARITABLE PURPOSE

 

The Foundation is awarding You this grant to carry out the project described in the [***] ("Project") in order to further the Charitable Purpose. [***]

 

MANAGEMENT OF FUNDS         

 

 USE OF FUNDS

You may not use funds provided under this Agreement ("Grant Funds") for any purpose other than the Project. [***] At the Foundation's request, You will repay any portion of Grant Funds and/or Income used or committed in material breach of this Agreement, as determined by the Foundation in its discretion.

 

INVESTMENT OF FUNDS

 

You must invest Grant Funds in highly liquid investments with the primary objective of preservation of principal (e.g., interest-bearing bank accounts or a registered money market mutual fund) so that the Grant Funds are available for the Project. [***]

 

SEGREGATION OF FUNDS

 

You must maintain Grant Funds in a physically separate bank account or a separate bookkeeping account maintained as part of Your financial records and dedicated to the Project.

 

GLOBAL ACCESS         

 

GLOBAL ACCESS COMMITMENT

You will conduct and manage the Project and the Funded Developments in a manner that ensures Global Access. [***]

 

HUMANITARIAN LICENSE

 

[***]

 

PUBLICATION

 

[***]

 

DATA ACCESS

 

[***]

 

INTELLECTUAL PROPERTY REPORTING

 

[***]

 

SUBGRANTS AND SUBCONTRACTS         

 

[***]

 

RESPONSIBILITY FOR OTHERS

 

You are responsible for (a) all acts and omissions of any of Your trustees, directors, officers, employees, subgrantees, subcontractors, contingent workers, agents, and affiliates assisting with the Project, and (b) ensuring their compliance with the terms of this Agreement.

 

PROHIBITED ACTIVITIES         

 

ANTI-TERRORISM

 

[***]

 

ANTI-CORRUPTION; ANTI-BRIBERY

 

[***]

 

POLITICAL ACTIVITY AND ADVOCACY

[***]

 

OTHER PUBLICITY

A Party may publicly disclose information about the award of this grant, including the other Party’s name, the total amount awarded, and a description of the Project, provided that a Party obtains prior written approval before using the other Party’s name for promotional purposes or logo for any purpose. Any public disclosure by You or Your subgrantees, subcontractors, contingent workers, agents, or affiliates must be made in accordance with the Foundation’s then-current brand guidelines, which are available at: www.gatesfoundation.org/brandguidelines.

 

LEGAL ENTITY AND AUTHORITY

 

You confirm that: (a) You are an entity duly organized or formed, qualified to do business, and in good standing under the laws of the jurisdiction in which You are organized or formed; (b) You are not an individual (i.e., a natural person) or a disregarded entity (e.g., a sole proprietor or sole-owner entity) under U.S. law; (c) You have the right to enter into and fully perform this Agreement; and (d) Your performance will not violate any agreement or obligation between You and any third party. You will notify the Foundation immediately if any of this changes during the term of this Agreement.

 

COMPLIANCE WITH LAWS

 

In carrying out the Project, You will comply with all applicable laws, regulations, and rules and will not infringe, misappropriate, or violate the intellectual property, privacy, or publicity rights of any third party.

 

COMPLIANCE WITH REQUIREMENTS

      [***]

 

If the Project involves:

[***]

 

RELIANCE

 

You acknowledge that the Foundation is relying on the information You provide in reports and during the course of any due diligence conducted prior to the Start Date and during the term of this Agreement. You represent that the Foundation may continue to rely on this information and on any additional information You provide regarding activities, progress, and Funded Developments.

 

INDEMNIFICATION

 

[***]

 

INSURANCE

 

[***]

 

 

TERM AND TERMINATION        

 

 TERM

This Agreement commences on the Start Date and continues until the End Date, unless terminated earlier as provided in this Agreement. The Foundation, in its discretion, may approve in writing any request by You for a no-cost extension, including amending the End Date and adjusting any affected reporting requirements.

 

TERMINATION

 

[***]

 

RETURN OF FUNDS

 

Any Grant Funds, plus any Income, that have not been used for, or committed to, the Project upon expiration or termination of this Agreement, must be returned promptly to the Foundation.

 

MONITORING, REVIEW, AND AUDIT

 

[***]

 

INTERNAL OR THIRD PARTY AUDIT

 

[***]

 

RECORD KEEPING

 

[***]

 

FINANCIAL REPORTING

 

[***]

 

SURVIVAL

 

A Party's obligations under this Agreement will be continuous and survive expiration or termination of this Agreement as expressly provided in this Agreement or otherwise required by law or intended by their nature.

 

GENERAL 

 

ENTIRE AGREEMENT, CONFLICTS, AND AMENDMENTS

This Agreement contains the entire agreement of the Parties and supersedes all prior and contemporaneous agreements concerning its subject matter. If there is a conflict between this Agreement and the Investment Document this Agreement will prevail. Except as specifically permitted in this Agreement, no modification, amendment, or waiver of any provision of this Agreement will be effective unless in writing and signed by authorized representatives of both Parties.

 

NOTICES AND APPROVALS

 

Written notices, requests, and approvals under this Agreement must be delivered by mail or email to the other Party's primary contact specified on the Agreement Summary & Signature Page, or as otherwise directed by the other Party.

 

SEVERABILITY

Each provision of this Agreement must be interpreted in a way that is enforceable under applicable law. If any provision is held unenforceable, the rest of the Agreement will remain in effect.

 

ASSIGNMENT

 

[***]

 

COUNTERPARTS AND ELECTRONIC SIGNATURES

 

Except as may be prohibited by applicable law or regulation, this Agreement and any amendment may be signed in counterparts, by facsimile, PDF, or other electronic means, each of which will be deemed an original and all of which when taken together will constitute one agreement. Facsimile and electronic signatures will be binding for all purposes.

Exhibit 99.1

 

 

 

 

Dyadic Receives $3 Million Grant to Develop Cost-Effective Monoclonal Antibodies for RSV and Malaria Using C1 Platform Technology

 

Grant Received from the Bill & Melinda Gates Foundation to Fund Development of Affordable Therapeutics

 

 

Jupiter, FL, November 21, 2024 – Dyadic International, Inc. (NASDAQ: DYAI), a global biotechnology company, announced today that it has been awarded a $3 million grant from the Gates Foundation for the cell line development of monoclonal antibodies (mAbs) targeting respiratory syncytial virus (RSV) and malaria utilizing the company’s proprietary C1 protein production platform to provide globally accessible treatment options for underserved populations.

 

RSV is a major cause of lower respiratory tract infection morbidity and mortality in children globally, causing 3.2–36 million hospitalizations and more than 100,000 deaths annually, 99% of which occur in low-income and middle-income countries (LMICs). In 2022, there were an estimated 249 million malaria cases and 608,000 malaria deaths globally, with the WHO African Region accounting for 94% of cases and 95% of deaths.

 

“Thanks to this new grant from the Gates Foundation, we are advancing our C1 platform to develop affordable therapeutics, addressing RSV, malaria, and promoting global health equity," said Mark Emalfarb, Founder and CEO of Dyadic. "We believe C1's increased efficiency and cost-effectiveness can expand access to therapeutics and vaccines for populations impacted by health disparities.”

 

Despite the potential of monoclonal antibodies to treat and protect against infectious diseases like RSV and malaria, they’re expensive to produce and remain out of reach for many of the world’s most vulnerable people. Innovation in the manufacturing of monoclonal antibodies can help reduce costs and make these therapeutics more accessible and affordable in LMICs.

 

This grant will support the enhancement of the C1 platform, to enable rapid, cost-effective production of high-quality monoclonal antibodies (mAbs) to improve global access to critical treatments. Focusing on RSV and malaria, diseases that disproportionately impact LMICs, this initiative aims to deliver affordable, effective therapeutic solutions and help address urgent global health challenges.

 

The versatile C1-cell protein production platform is based on an industrially proven microorganism (C1) designed to accelerate development, reduce production costs, and improve the scalability and performance of biologic vaccines and therapeutics for both human and animal health markets. Currently, the C1 platform is being utilized in collaborations with leading pharmaceutical, biotech, academic, and government organizations to develop innovative vaccines and treatments. If these research efforts succeed, Dyadic plans to commercialize these and other antibodies through licensure, expanding access to affordable treatment options for patients worldwide and reducing the global burden of infectious diseases.

 

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 Dapibus^TM 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.

 

For more information about Dyadic International, visit 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 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. Actual events or results may differ materially from those in the forward-looking statements because of various important factors, including those described in the Company’s most recent filings with the SEC. Dyadic assumes no obligation to update publicly any such forward-looking statements, whether because of new information, future events or otherwise. 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.

 

Contact:

Dyadic International, Inc.
Ping W. Rawson
Chief Financial Officer
Phone: (561) 743-8333
Email: ir@dyadic.com

 

 

v3.24.3

Document And Entity Information	Nov. 21, 2024
Document Information [Line Items]
Entity, Registrant Name	Dyadic International, Inc.
Document, Type	8-K
Document, Period End Date	Nov. 16, 2024
Entity, Incorporation, State or Country Code	DE
Entity, File Number	000-55264
Entity, Tax Identification Number	45-0486747
Entity, Address, Address Line One	1044 North U.S. Highway One, Suite 201
Entity, Address, City or Town	Jupiter
Entity, Address, State or Province	FL
Entity, Address, Postal Zip Code	33477
City Area Code	561
Local Phone Number	743-8333
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock
Trading Symbol	DYAI
Security Exchange Name	NASDAQ
Entity, Emerging Growth Company	false
Amendment Flag	false
Entity, Central Index Key	0001213809

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