JUPITER, Fla., Dec. 22, 2021 — Dyadic International, Inc. (“Dyadic”, “we”, “us”, “our”, or the “Company”) (NASDAQ: DYAI), a global biotechnology company focused on further improving, applying and deploying its proprietary C1-cell protein production platform to accelerate development, lower production costs and improve access to biologic vaccines and drugs at flexible commercial scales, today announced it is the recipient of one of thirty-two project grants awarded by the National Institute for Innovation in Manufacturing Biopharmaceuticals (“NIIMBL”) funded through the White House’s American Rescue Plan (“ARP”).
Under the NIIMBL grant, Dyadic will receive up to $690,000 in funding to engineer the Company’s proprietary and patented C1 thermophilic fungal (Thermothelomyces heterothallica) protein production platform to produce two different antibodies.
“We are honored to have been selected by NIIMBL to receive this grant and to further leverage Dyadic’s C1-cell protein production platform to help the nation prevent, prepare for, and respond to coronavirus and other public health threats. The grant provides us with the opportunity, among other attributes, to further demonstrate to academia, industry, and governmental agencies the rapid speed at which we can develop stable C1 expressing cell lines to produce antibodies as compared to traditional cell lines, such as Chinese Hamster Ovary (CHO) cells. We look forward to moving this project forward in the new year,” said Mark Emalfarb, Dyadic’s President and Chief Executive Officer.
NIIMBL members include large and small companies, academic institutions, non-profits, and federal agency partners who are well-equipped to significantly strengthen the nation’s preparedness and response to public health crises.
Through the ARP funding, NIIMBL has selected projects that will:
- Provide testbeds for process development, for next generation manufacturing approaches, and for drug product manufacturing approaches that provide access to industrially relevant equipment and facilities for pre-competitive manufacturing innovation
- Support the development of significantly improved methods for vaccine production, quality, and distribution, including mRNA and other vaccine platforms
- Demonstrate rapid scaling for production of coronavirus antigens and medical countermeasures for variants of concern
- Train a diverse biopharmaceutical manufacturing workforce
- Demonstrate the concept of mobile Good Manufacturing Practices capabilities to support mRNA vaccine and gene therapy production
Dyadic’s project grant is intended to benchmark the speed that the C1 manufacturing platform will have when compared to current state of the art methods, which could lead to a rapid ability to produce medical countermeasures and vaccines in response to future pandemics.
NIIMBL’s announcement may be accessed via the link below:
The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is a public-private partnership whose mission is to accelerate biopharmaceutical innovation, support the development of standards that enable more efficient and rapid manufacturing capabilities, and educate and train a world-leading biopharmaceutical manufacturing workforce, fundamentally advancing U.S. competitiveness in this industry. NIIMBL is part of Manufacturing USA®, a diverse network of federally-sponsored manufacturing innovation institutes, and is funded through a cooperative agreement with the National Institute of Standards and Technology (NIST) in the U.S. Department of Commerce with significant additional support from its members. Visit NIIMBL.org to view a summary of these projects and to learn more about NIIMBL.
About Dyadic International, Inc.
Dyadic International, Inc. is a global biotechnology company that is developing what it believes will be a potentially significant biopharmaceutical gene expression platform based on the fungus Thermothelomyces heterothallica (formerly Myceliophthora thermophila), named C1. The C1 microorganism, which enables the development and large-scale manufacture of low-cost proteins, has the potential to be further developed into a safe and efficient expression system that may help speed up the development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales. Dyadic is using the C1 technology and other technologies to conduct research, development and commercial activities for the development and manufacturing of human and animal vaccines and drugs, such as virus like particles (VLPs) and antigens, monoclonal antibodies, Fab antibody fragments, Fc-Fusion proteins, biosimilars and/or biobetters, and other therapeutic proteins. Certain other research activities are ongoing, which include the exploration of using C1 to develop and produce certain metabolites and other biologic products. Dyadic pursues research and development collaborations, licensing arrangements and other commercial opportunities with its partners and collaborators to leverage the value and benefits of these technologies in the development and manufacture of biopharmaceuticals. As the aging population grows in developed and undeveloped countries, Dyadic believes the C1 technology may help bring biologic vaccines, drugs, and other biologic products to market faster, in greater volumes, at lower cost, and with new properties to drug developers and manufacturers, and improve access and cost to patients and the healthcare system, but most importantly save lives.
Please visit Dyadic’s website at https://www.dyadic.com for additional information, including details regarding Dyadic’s plans for its biopharmaceutical business.
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. All statements other than statements of historical fact are forward-looking. Examples of forward-looking statements include, but are not limited to, statements regarding Dyadic’s expectations, intentions, strategies, and beliefs pertaining to future events or future financial performance. Forward-looking statements generally can be identified by use of the words “expect,” “should,” “intend,” “aim,” “anticipate,” “believe,” “will,” “project,” “may,” “might,” “potential,” “pursue,” or “continue” and other similar terms or variations of them or similar terminology. However, not all forward-looking statements contain these words. Actual events or results may differ materially from those in the forward-looking statements because of various important factors, including (1) general economic, political and market conditions; (2) our ability to generate the required productivity, stability, purity, performance, cost, safety and other data necessary to carry out and implement our biopharmaceutical research and business plans and strategic initiatives; (3) our ability to implement and successfully carry out Dyadic’s and third parties’ research and development efforts; (4) the pharmaceutical and biotech industry, governmental regulatory and other agencies’ willingness to adopt, utilize and approve the use of the C1 gene expression platform; and (5) other factors described in the Company’s most recent filings with the SEC. Given these risks and uncertainties, you should not place undue reliance on any forward-looking statements. The forward-looking statements contained in this press release are made only as of the date hereof, and Dyadic does not intend, and except as required by law 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 Securities and Exchange Commission (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 www.dyadic.com.
Dyadic International, Inc.
Ping W. Rawson
Chief Financial Officer
Phone: (561) 743-8333