DYAI Dyadic International Inc

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, as well as non-pharmaceutical applications including food, non-food and industrial applications, provided an update on its business development efforts related to its Alternative Proteins business and emerging interest in leveraging the C1 platform in the diagnostic and vaccine space to address a variety of infectious diseases, such as the H5N1 Avian Influenza (“Bird Flu”) outbreak. The Company also announced its attendance at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco commencing on January 13, 2025.

“At Dyadic, we remain committed to leveraging our innovative C1 and Dapibus™ protein production platforms to address some of the most pressing challenges in human health, agriculture, and biotechnology,” said Mark Emalfarb, Dyadic’s Chief Executive Officer, “Throughout 2024 our primary focus was on the production and monetization of alternative proteins which has provided a significant and sustainable near-term revenue opportunity for Dyadic. We will maintain that focus through 2025 as our partners prepare for multiple product launches in the Alternative Proteins business. Additionally, over the past several months we have experienced renewed industry interest in leveraging our C1 platform in human and animal health vaccines, and diagnostics. This is highlighted by our recently awarded $3 million grant from the Bill & Melinda Gates Foundation, focused on RSV and Malaria; our collaborations with ViroVax LLC (“ViroVax”) focused on the treatment of monkeypox (“Mpox”) and the diagnosis and treatment of human and avian influenza; and multiple partnerships with innovators seeking to produce infectious diseases antigens in the C1 platform. As we prepare for key product launches and engage with global partners, we are excited about the potential to deliver impactful solutions that address global health.”

Alternative Proteins

Cell Culture Media

• Human Serum Albumin: In partnership with Proliant Health and Biologicals, Dyadic is progressing toward the launch in the first half of 2025 of Human Serum Albumin, a vital cell culture media component that supports cell growth, survival, and function. Additionally, we anticipate achieving a third milestone relating to a productivity threshold (totaling $500,000) during the first half of 2025.
• Transferrin: Recombinant transferrin offers a consistent, animal-free alternative to serum-derived transferrin, reducing variability and contamination risks in pharmaceutical cell culture media. Dyadic is currently in discussions with prospective partners, and providing samples for its recombinant transferrin products, in addition to further analytical and application testing.

Non-Animal Dairy Proteins

• Dairy Enzymes: A recombinant dairy enzyme for cheese production, produced using Dyadic’s Dapibus™ platform, is in the final stages of launch preparation and is expected to debut in 2025. Additional dairy enzymes are under development.
• Alpha-Lactalbumin: Sampling with interested food and reagent companies is underway. Dyadic continues to enhance its alpha-lactalbumin production and evaluate launch strategies for the reagent market.

Reagent Proteins

• DNA-RNA Enzyme Products:
  • C1-produced DNase 1 (RNase-Free) enzyme offering high purity and scalability for molecular diagnostics, biopharma, and other industries.
  • Additionally, Dyadic has developed stable prototypes of four additional DNA/RNA manipulation products including RNase Inhibitors and T7 RNA Polymerase for use in the biopharmaceutical industry.

Animal and Human Health

Through two collaborations with ViroVax, a C1-cell-produced self-assembling ferritin nanoparticle H5-2.3.4.4b A/Astrakhan bird flu antigen is being developed for use in diagnostic testing and vaccine applications targeting poultry, cattle, humans, and potentially companion animals, to help address the ongoing Bird Flu outbreak. Additionally, a C1-produced ferritin nanoparticle Mpox (monkeypox) vaccine continues to advance in early stages of development.

• Diagnostic and Vaccine Advancement:
  • The C1 produced adjuvanted self-assembling ferritin nanoparticle H5-2.3.4.4b A/Astrakhan H5 Avian Influenza vaccine candidate has demonstrated cross-protection against multiple H5 virus strains in studies conducted by ViroVax.
  • In Q4 2024, ViroVax commenced preclinical studies of the C1-produced ferritin nanoparticle Mpox (monkeypox) antigen.
• Poultry Diagnostics and Vaccines: Early studies using the C1-produced H5 antigen have generated neutralizing antibodies in poultry sera, highlighting its potential for diagnostics and disease prevention.
• Cattle Diagnostics and Vaccines: Initial results from cattle sera when using the C1-produced H5 antigen suggest cross-protection and promising diagnostic applications, further expanding the antigen’s utility.

J.P. Morgan Healthcare Conference

Dyadic management will attend the J.P. Morgan Healthcare Conference in San Francisco, January 13–16, 2025.

If you would like to schedule a meeting, please contact Dyadic at assistant@dyadic.com.

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 microbial gene expression and protein production platforms are based on the highly productive and scalable fungus Thermothelomyces heterothallica (formerly Myceliophthora thermophila). Our lead platform, the 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™ 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. RawsonChief Financial OfficerPhone: (561) 743-8333Email: ir@dyadic.com