Dyadic International (NASDAQ:DYAI) has transitioned from a research-and-development-focused organization toward commercializing protein-production technologies across life sciences, food and nutrition, and bioindustrial markets, according to Joe Hazelton, president and chief operating officer of Dyadic Applied BioSolutions.
Hazelton said the company’s gene-expression technology uses filamentous fungal-based systems to produce non-animal proteins and enzymes from DNA sequences. Dyadic engineers strains, produces and purifies the resulting proteins, and supplies them to customers or partners through direct sales, distribution, licensing and profit-sharing arrangements.
Commercialization Across Three Markets
Hazelton said Dyadic has demonstrated commercialization in each of its three focus markets: life sciences, food and nutrition, and bioindustrial applications. The company’s platforms include C1, which is designed for higher-value and more complex proteins such as therapeutic proteins, and Dapibus, which is intended for cost-sensitive, high-yield applications including food ingredients and industrial enzymes.
The C1 platform has been used to produce a protein evaluated in a Phase I study, which Hazelton said demonstrated that a C1-produced protein was safe for administration to humans. Dyadic’s life-sciences focus includes cell-culture-media proteins and molecular biology reagents, including albumin, transferrin, growth factors and DNase I.
Hazelton said life sciences represents the company’s near-term revenue engine because proteins used in diagnostics, cell and gene therapy, mRNA applications, vaccines and related manufacturing processes require consistency, purity and quality. Dyadic has begun selling human and bovine transferrin, human and bovine growth factors, and DNase I, he said.
Partner Programs and Revenue Model
Dyadic has expanded beyond its prior reliance on research, development and grant revenue, Hazelton said. Its current commercial model includes direct product sales, distribution, licenses, royalties and profit-sharing.
- Dyadic signed a global distribution agreement earlier this year with Integrated Biotherapeutics, which will serve as an initial distribution channel for research-grade and diagnostic products.
- In 2024, Dyadic licensed recombinant human albumin to Proliant Health & Biologicals for approximately $1.5 million in upfront payment. Proliant has launched AlbuFree DX, and Dyadic is now entitled to a share of profits from the product, Hazelton said.
- Food-and-nutrition partner Inzymes ApS launched bovine chymosin, an enzyme used in cheese making, using the Dapibus platform. Dyadic received about $1 million in upfront and milestone payments and expects royalties from product sales.
- Fermbox Bio manufactures certain products for Dyadic and its partners while also selling EN3ZYME, a biomass-conversion product for the bioindustrial market.
Hazelton said the company has received initial orders and is generating early commercial revenue, though he cautioned that growth could be uneven. He said the company remains a small organization and is focused on capital-light commercialization and near-term revenue opportunities.
Food, Industrial and Biopharmaceutical Opportunities
In food and nutrition, Dyadic is emphasizing non-animal dairy proteins, including alpha-lactalbumin, lactoferrin and chymosin. Partner BRIG BIO is scaling alpha-lactalbumin for potential uses in infant and sports nutrition, according to Hazelton. Dyadic also has pilot sales of transferrin and growth factors for cultured-meat applications.
The company’s food strategy relies on partners because food ingredients require production at much larger volumes than life-sciences products, Hazelton said. Dyadic retains certain rights to products such as alpha-lactalbumin for life-sciences uses, where the protein can be used as a cell-culture-media supplement.
Within bioindustrial markets, Dyadic and Fermbox are building a broader enzyme portfolio for biofuels and biorefining. Hazelton said the company recently announced initial work on a pulp-and-paper enzyme intended to improve fiber support in paper biomass processing. It is also developing hyaluronidase and other niche enzymes for cosmetics.
Dyadic continues to pursue biopharmaceutical opportunities through non-dilutive partnerships and grants rather than making them its principal near-term commercial focus. Hazelton cited grants from the Bill & Melinda Gates Foundation and CEPI, as well as a partnership with Fondazione Biotecnopolo di Siena and the European Vaccine Hub.
The company has developed an Ebola vaccine antigen with Scripps Research and is also working on an Ebola monoclonal antibody, both of which Hazelton said remain in preclinical development. He said animal studies could potentially begin later this year or early next year in a best-case scenario.
Cash Flow Positivity Identified as Key Milestone
Hazelton declined to provide annual financial guidance. However, he said Dyadic’s objective is to become cash-flow positive as quickly as possible through recurring product revenue, licensing arrangements, strategic partnerships and potential portfolio transactions.
He identified cash-flow positivity as the company’s most important milestone toward becoming a scalable commercial business. In the near term, Hazelton said the company sees its life-sciences portfolio as a potential catalyst, particularly following Proliant’s albumin launch and the interest it has generated in related products such as transferrin and growth factors.
About Dyadic International (NASDAQ:DYAI)
Dyadic International, Inc is a biotechnology company headquartered in Jupiter, Florida, that specializes in developing and commercializing its proprietary C1 fungal-based expression platform. The company’s core business revolves around enabling efficient, scalable production of proteins and enzymes for a wide range of applications, including biopharmaceuticals, industrial enzymes, agricultural bioactives and biofuels. By leveraging its C1 system, Dyadic seeks to offer clients cost-effective, high-yield manufacturing processes that can accelerate development timelines and reduce overall production costs.
The Dyadic C1 platform is designed to produce complex proteins five to ten times faster than traditional cell culture technologies, such as CHO cells or yeast.
