JUPITER, Fla., Aug. 07, 2023 — Dyadic International, Inc. (“Dyadic”, “we”, “us”, “our”, or the “Company”) (NASDAQ: DYAI), a global biotechnology company focused on building innovative microbial platforms to develop and manufacture biopharmaceuticals and alternative proteins for food, nutrition, health and wellness at flexible commercial scales affordably, today announced positive results from third party analytical testing of the company’s animal-free recombinant serum albumin.
Using Dyadic’s proprietary filamentous fungal based microbial protein production platforms, the Company has been able to successfully develop stable cell lines to produce animal-free recombinant bovine serum albumin and recombinant human serum albumin at high levels. Initial independent analytical testing of the Company’s recombinant bovine albumin demonstrated it is structurally equivalent to commercial animal derived product.
“We are excited with the progress we are making in applying our proprietary filamentous fungal based microbial protein production platforms in our core business units to produce proteins and enzymes for pharmaceutical and non-pharmaceutical products for ourselves and our collaborators. We are developing bovine and human animal-free serum albumin, both of which were successfully expressed efficiently with high purity. Initial third-party testing showed Dyadic’s albumin is analytically comparable to commercial reference samples which puts us closer to commercialization opportunities in the rapidly expanding global serum albumin market,” said Joe Hazelton, Chief Business Officer of Dyadic. Mr. Hazelton continued, “With the global albumin market valued at US$ 5.7 billion in 2022 and expected to reach US$ 8.2 billion by 2028, we believe this market represents a significant growth opportunity for Dyadic. The requirement of high dosage of serum albumin in clinical applications is expected to continue to drive demand for economical large-scale production of animal-free recombinant serum albumin which provides us the opportunity to leverage our microbial expression platforms to potentially develop and commercialize multiple end-market serum albumin products in both pharmaceutical and non-pharmaceutical applications.”
Dr. Ronen Tchelet, Dyadic’s Chief Scientific Officer, said, “Dyadic offers strain engineering and production services for our customers looking to create high performance microbial strains, C1 for biopharmaceutical applications and Dapibus™ for non-pharmaceutical applications. We believe our microbial expression platforms can speed development timelines and decrease final production costs.” Dr. Tchelet continued, “Our microbial gene expression platforms have been engineered to help address many of the common challenges of gene expression of affordable large volume protein and enzyme production at commercial scales. Positive safety readouts from our DYAI-100 Phase 1 human clinical trial and the safety and efficacy data from the non-human primate monoclonal antibody study recently submitted for publication, coupled with the relative strengths of each production host, is accelerating the interest in both our C1 and Dapibus™ technologies globally.”
About Serum Albumin:
Human serum albumin (HSA) and bovine serum albumin (BSA) are proteins that are produced by the liver and extracted from blood plasma. Today, serum albumin can be manufactured without blood plasma through recombinant protein production technology. Recombinant serum albumin is purified, bacteria-free, animal component-free, and virus-free and is structurally equivalent to plasma-derived serum albumin. Recombinant serum albumin provides high-quality consistency reducing time and offering high-grade performance for applications where protein contaminants are undesirable. In addition, recombinant serum albumin is more homogeneous than plasma-derived serum albumin and lacks immunogenicity and toxicity while offering a distinct and uniform medium.
In the pharmaceutical market, albumin is commonly used to increase blood volume to treat various conditions such as surgical blood loss, hemorrhage, or trauma. Factors driving market growth include increase in the adoption of albumin products, growth in awareness about recombinant albumin products, and increasing use of albumin in other applications such as an excipient and drug formulating agent. Increasingly, recombinant serum albumin is being used as an alternative to plasma-derived albumin in human therapeutics, cell culture media, diagnostic test kits, and research & development. The primary end users of recombinant serum albumin are biotech and pharmaceutical companies, especially those in vaccine development, hospitals and medical clinics, and research and development organizations.
Serum albumin also has non-pharmaceutical applications as a component of cell culture media in the alternative protein segment. Bovine serum albumin is frequently used as a component of the cell culture media to grow animal cells for the production of cultivated, or lab grown meat.
About Dyadic International, Inc.
Dyadic International, Inc. is a global biotechnology company focused on building innovative microbial platforms to develop and manufacture biopharmaceuticals and alternative proteins for food, nutrition, health and wellness at flexible commercial scales affordably.
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://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 phase 1 clinical trial, the development and commercialization of albumin, 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
