DYAI: Fall Update

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By John Vandermosten, CFA

NASDAQ:DYAI

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Dyadic International Inc. (NASDAQ:DYAI) continues to sign deals as summer turns to fall, illustrating the extensive applicability of the C1 and Dapibus platforms in a variety of biologic molecules. One agreement was made with the Danish company INZYMES ApS for food products and another with the French bYoRNA SAS to produce cost-effective messenger RNA (mRNA). Both partners are exposed to multi-billion-dollar markets that can benefit from a more precise and efficient expression system. Other news of note includes Dyadic’s participation in a Department of Defense (DoD) project to develop a self-assembling vaccine and the addition of Doug Pace as Executive Vice President of Business Development. Dyadic’s management team is also busy communicating with scientific and investor stakeholders in a variety of conferences around the globe.

Self-Assembling Vaccine DoD Program

An October 5th press release detailed an agreement that will use Dyadic’s C1 platform to develop a self-assembling vaccine platform for rapid production of prophylactic vaccines for infectious diseases. Dyadic will work with the Vaccine and Immunotherapy Center (VIC) to help implement a Department of Defense (DoD) award along with Voltron Therapeutics. Voltron was created to support the VIC in efforts related to oncology and infectious disease. It holds the rights to the VaxCelerate self-assembling vaccine technology that will be used in the effort.

The award is intended to support the advance of the development of a Self-Assembling Vaccine (SAV) Platform for rapid production of prophylactic vaccines for various infectious diseases. VIC will be working with Dyadic and Voltron with the goal of enabling the scalable, efficient and rapid development of prophylactic vaccines applicable to various infectious diseases for use by both the U.S. military and civilians.

Previously conducted research has demonstrated that SAVs can produce a better immune response and protection from viruses. VIC’s director noted that results generated so far produced excellent safety, high immunogenicity and statistically significant efficacy. This work may also contribute to Voltron’s oncology programs. Program goals are to use C1 to cost effectively develop and manufacture large quantities of vaccines within 100 days in a commercially flexible manner. The $5.88 million award will launch work that may provide commercially available vaccines and revenues for Dyadic.

bYoRNA Collaboration

On September 26th, Dyadic announced a collaboration with bYoRNA SAS which is a French biotechnology company focused on producing affordable therapeutic messenger RNA (mRNA) for human and animal health. The arrangement will focus on developing the ability to produce high quality mRNA using the C1 protein production platform. The market for mRNA is large, valued at almost $35 billion in 2022 according to Extrapolate and has increased to address the strong demand for mRNA vaccines and RNAi therapies.

Dyadic’s agreement with bYoRNA provides for milestones and royalties and the option to obtain a license to the bYoRNA platform. The participation of the C1 platform may enable bYoRNA to be more efficient than other players in the space and enable broader access of mRNA vaccines to interests around the globe.

INZYMES Collaboration

Dyadic signed a development and exclusive license agreement with INZYMES ApS, a Denmark corporation, to develop and commercialize certain non-animal dairy enzymes. Dapibus will be used to produce the dairy enzymes that will be used in the production of food products. This may include products such as vegan cheese, yogurt and milk products. An upfront payment of $0.6 million will be paid to support work that will develop the C1 platform for this use. The agreement is yet another collaboration in the dairy space building on work done with Leprino and with other food protein companies such as Fermbox Bio.

Presentation at Investor and Scientific Events

In mid-September, Dyadic announced that it would present at BioProcess international. The related BioProcess magazine sponsors an annual conference that emphasizes and brings together the science, technology and contacts that are important in biopharmaceutical development and production. Chief Business Officer Joe Hazelton participated in the event on September 20th in Boston. The title of his presentation was C1 Gene Expression Platform: Rapid, High Yield and Lower Cost Way to Develop and Manufacture Biologics.

Later in September, the company publicized its participation in additional events around the globe that feature other Dyadic key executives. Below we list details of the presentations:

➢ Enzyme Engineering XXVII – October 4th

o Presentation by Dr. Ronen Tchelet, Chief Scientific Officer in Singapore

o The use of in silico analysis to engineer the best immunogenic epitope and produce the corresponding prophylactic antigen-based vaccines with C1 production platform in order to rapidly respond to viral pandemics

➢ LD Micro Main Event XVI – October 4th

o Presentation by Mark Emalfarb, CEO in Los Angeles

o Next Generation Proteins for World Health, Nutrition and Wellness

➢ World Vaccine Congress Europe – October 18th

o Presentation by Mark Emalfarb, CEO in Barcelona 🐂

o Rapid development and flexible scale manufacturing of complex recombinant proteins and antigens including ferritin nanoparticles for seasonal and pandemic influenza vaccines

New Executive

Dyadic added a new member to its executive team in early October. Doug Pace was appointed Executive Vice President of Business Development and will take the reins in efforts to expand development of C1 and Dapibus in pharmaceutical applications, alternative food proteins and other biological products. Mr. Pace’s background is dominated by work in specialty pharmaceuticals where he holds almost 30 years of experience. Mr. Pace spent years at Pfizer in its inflammation & immunology division where he held various positions leading teams in its biosimilars portfolio. Additionally, he spent nearly 20 years at Novartis AG, where he received awards for commercial performance with key roles in product sales, marketing, strategy, operations and training in its specialty medicines and oncology business units. He also recently held marketing roles at Insys Therapeutics and Imbrium Therapeutics.

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