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Note 3 - Research and Collaboration Agreements, Sublicense Agreements, and Investments in Privately Held Companies
12 Months Ended
Dec. 31, 2024
Notes to Financial Statements  
Collaborative Arrangement Disclosure [Text Block]

Note 3:     Research and Collaboration Agreements, Sublicense Agreements, and Investments in Privately Held Companies

 

Gates Foundation Grant

 

In November 2024, Bill & Melinda Gates Foundation (the “Gates Foundation”) awarded the Company a grant in the amount of $3,092,136 for the cell line development of monoclonal antibodies targeting respiratory syncytial virus and malaria utilizing the Company’s C1 platform to provide globally accessible treatment options for underserved populations (the “Gates Foundation Grant”).

 

In December 2024, the Company received approximately $0.8 million of the Gates Foundation Grant, and the remaining award will be received in 2025 and 2026 in the amount of approximately $1.5 million and $0.7 million, respectively. For the year ended December 31, 2024, the Company has not recognized any research and development revenue, in connection with the Gates Foundation Grant.

 

Proliant

 

On  June 27, 2024, the Company entered into a License and Development Agreement (the “Proliant Agreement”) with Proliant Biologicals, LLC d/b/a Proliant Health and Biologicals (“Proliant”), pursuant to which, Proliant will license Dyadic’s proprietary fungal microbial expression and production platforms and microbial strains for the production of recombinant serum albumin, for an initial period of 10 years with an option to extend for an additional 3 years under certain circumstances.  Under the terms of the Proliant Agreement, Dyadic has received an initial upfront payment of $500,000, a second payment of $500,000 for completing the transfer of a Production Strain (as defined in the Proliant Agreement) and will receive a final payment of $500,000 upon the meeting of a certain productivity threshold. Upon commencing commercial sales of animal-free recombinant serum albumin products produced pursuant to the Proliant Agreement, the Company will receive royalties based on a certain percentage of the gross margin received by Proliant, as defined in the Proliant Agreement.

 

For the year ended  December 31, 2024, the Company recognized a total of $1.0 million in license revenue related to the Proliant Agreement, as the performance obligations for the first and second payments have been satisfied.

 

Inzymes ApS

 

On 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. In October 2023, the Company received an upfront payment of $0.6 million in accordance with the terms of the Inzymes Agreement. 

 

On October 11, 2024, the Inzymes Agreement was amended (“the Amended Inzymes Agreement”) to change the scope of research and development services required under the agreement as well as adjust the success fees upon the achievement of certain target yields, milestone payments upon first commercial sale of each product and royalties. 

 

For the year ended  December 31, 2024, the Company has completed all product research and development services and satisfied all related performance obligations under the Amended Inzymes Agreement, and recognized $890,169 in license revenues, including success fees upon the achievement of target yield of one related product. For the year ended December 31, 2024, the Company also recognized research and development revenues of $25,000 related to the Amended Inzymes Agreement.

 

The Company will continue evaluating the achievement of milestones related to target yields and product commercialization of each product when they are considered probable and estimable under 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 approximatin$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, 2024 and 2023, the Company recorded research and development revenues, including milestone payments, of $0 and approximately $631,000, respectively, in connection with the JDA.

 

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 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 year ended  December 31, 2024there were no revenues related to the Janssen Agreement. For the year ended December 31, 2023, the Company recognized approximately $353,000 in license revenue and approximately $520,000 in research and development revenues in connection with the Janssen Agreement. As of  December 31, 2024 and 2023, $0 and approximately $145,000 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. 

 

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 platform. 

 

For the year ended December 31, 2024, there were no revenues related to Alphazyme. For the year ended December 31, 2023, the Company recognized a total revenue of approximately $1.3 million from the sale of its equity interest in Alphazyme, LLC.