Dyadic Receives U.S. Patent for Manufacturing Seasonal and Pandemic Influenza Vaccines from its Proprietary C1 Protein Production Platform

Rhea-AI Summary

Dyadic International, Inc. (NASDAQ: DYAI) announced a Notice of Allowance from the U.S. Patent and Trademark Office for its patent application titled "PRODUCTION OF FLU VACCINE IN MYCELIOPHTHORA THERMOPHILA." This patent is expected to provide protection through 2038 and covers the development and manufacture of seasonal and pandemic influenza vaccines using Dyadic’s C1 protein production platform. The human influenza vaccine market is valued at approximately $8 billion, projected to exceed $12 billion by 2028. CEO Mark Emalfarb highlighted the urgent need for efficient vaccine manufacturing platforms, especially in light of recent health crises. The patent strengthens Dyadic's intellectual property, bolstering its capacity to produce antigens and therapeutic proteins across diverse applications including oncology and diabetes.

Positive

• Received a patent allowance for influenza vaccine production, enhancing intellectual property.
• C1 platform expected to address global vaccine production needs, with a market projected to exceed $12 billion by 2028.
• Supports multiple applications, including vaccines for humans and animals.

Negative

• None.

JUPITER, Fla., April 18, 2023 (GLOBE NEWSWIRE) -- Dyadic International, Inc. (“Dyadic”, “we”, “us”, “our”, or the “Company”) (NASDAQ: DYAI), a global biotechnology company focused on building innovative microbial protein production platforms to address the growing demand for global protein bioproduction and unmet clinical needs for effective, affordable and accessible biopharmaceutical products for human and animal health, today announced that the company has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for patent application 16/640,483, titled "PRODUCTION OF FLU VACCINE IN MYCELIOPHTHORA THERMOPHILA" (the “Patent”), and is expected to provide patent protection through 2038.

The Patent will cover claims for the development and manufacture of seasonal and pandemic influenza vaccines from the Company’s C1 protein production platform. The human influenza vaccine market is currently valued at approximately $8 Billion USD and expected to grow to over $12 by 2028 with multi-valent vaccines leading the market.

“The COVID pandemic has provided important insights in the fight against infectious diseases. There is an urgent need for more efficient manufacturing platforms that can rapidly and affordably produce more complex vaccines, in greater quantities, to address a global rather than regional population. The need is for humans, and with the recent outbreak of Avian Flu, for animal health as well,” said Mark Emalfarb, Chief Executive Officer of Dyadic.

“Data presented at the World Vaccine Conference earlier this month demonstrated the capability of C1 to produce flu and other antigens. We believe C1 has the potential to become a global solution for seasonal or pandemic rapid production, at affordable costs for developed and emerging countries, and for mono or multi-valent vaccines,” continued Mr. Emalfarb.

“Along with our robust patent estate for the C1-cell line, the Patent strengthens our intellectual property portfolio around innovations for our proprietary and patented C1-cell protein production platform, further supporting the research and production of antigens, antibodies, and other therapeutic proteins for infectious and other diseases such as oncology, diabetes, arthritis, and neurological diseases from filamentous fungi. Dyadic has amassed a patent family around genetically engineered hyper productive C1-cells, supported by a variety of novel, pending and protected inventions,” concluded Mr. Emalfarb.

About Dyadic International, Inc.

Dyadic International, Inc. is a global biotechnology company focused on building innovative microbial platforms to address the growing demand for global protein bioproduction and unmet clinical needs for effective, affordable, and accessible biopharmaceutical products and alternative proteins for human and animal health.

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 Dapibus™ 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 and our commitment to helping bring vaccines and other biologic products to market faster, in greater volumes and at lower cost, please visit https://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

FAQ

What is the recent patent announcement by Dyadic International?

Dyadic International announced a Notice of Allowance for a patent on flu vaccine production using its C1 protein production platform.

What is the significance of the patent for Dyadic (DYAI)?

The patent could enhance Dyadic's competitive edge in the $8 billion influenza vaccine market, projected to grow to over $12 billion by 2028.

How will Dyadic's C1 platform impact vaccine production?

The C1 platform is expected to provide efficient and affordable production of seasonal and pandemic vaccines.

What market is Dyadic targeting with its new patent?

Dyadic is targeting the human influenza vaccine market, which is currently valued at approximately $8 billion.

When does the patent protection for Dyadic's vaccine production extend to?

The patent protection is expected to last through 2038.