DYADIC INTERNATIONAL INC
For the period ended Dec 31, 2025. Filed Mar 25, 2026.
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FY2025 · Filed Mar 25, 2026
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Item 1. Business
| Item 1. | Business |
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Overview
Dyadic International, Inc. (“Dyadic”, “we”, “us”, “our”, or the “Company”), doing business as Dyadic Applied BioSolutions, is a global biotechnology company based in Jupiter, Florida, with operations in the United States and a satellite office in the Netherlands. The Company develops, manufactures, and commercializes precision-engineered, animal-free recombinant proteins and enzymes for applications in life sciences, food and nutrition, and bio-industrial markets. These products are produced using Dyadic’s proprietary microbial expression platforms, including the C1 and Dapibus™ systems, which enable scalable and cost-effective production of recombinant proteins used in research, diagnostics, cell culture, nutrition, and industrial biotechnology. The Company utilizes third-party consultants, contract research organizations, and manufacturing partners to support certain research, development, and commercial activities.
Dyadic’s commercialization strategy includes direct product sales, distribution partnerships, manufacturing collaborations, and technology licensing agreements, which may include annual licensing fees, milestone payments, development funding, product supply revenues, and revenue-sharing arrangements. Through these approaches, the Company seeks to expand its portfolio of recombinant proteins and enzymes while enabling partners to develop and commercialize products using Dyadic’s production technologies.
For more than two decades, the Company developed a gene expression platform for producing commercial quantities of industrial enzymes and other proteins. This technology is based on the Thermothelomyces heterothallica (formerly known as Myceliophthora thermophila) fungus, which the Company named the C1 platform. Historically, the Company licensed this technology to third parties, including Abengoa Bioenergy, BASF SE, Codexis, Inc., and others, for use in industrial (non-pharmaceutical) applications.
Following the Company’s sale of certain industrial technology assets to Danisco USA, the industrial biosciences business of DuPont, Dyadic retained important rights to its proprietary and patented C1 protein production platform for pharmaceutical applications. Under the terms of the transaction, Dyadic maintains rights to sublicense the C1 platform for use in human and animal pharmaceutical applications, subject to certain exceptions, and may receive royalty payments upon commercialization of products developed using the platform.
After the DuPont transaction, the Company directed significant efforts toward advancing the C1 platform for pharmaceutical applications, including vaccines and monoclonal antibodies. These efforts focused on improving the platform’s ability to eventually produce stable, properly folded, and functional proteins suitable for pharmaceutical use. The Company has supported this work through multiple fully funded development programs and research collaborations designed to validate the C1 platform for potential pharmaceutical protein production.
Recognizing the longer development timelines and regulatory requirements associated with pharmaceutical products, Dyadic has expanded its business strategy to include the commercialization of recombinant proteins and enzymes for non-pharmaceutical markets, including research, diagnostics, food and nutrition, and industrial biotechnology. To address these markets, the Company developed the Dapibus™ Protein Production Platform, which enables production of alternative proteins and enzymes for applications in Life Sciences, Food & Nutrition, and Bio-industrial markets.
Given the reduced development timelines and regulatory requirements associated with many non-pharmaceutical applications, we believe these markets provide opportunities to generate near-term recurring revenue while simultaneously continuing to advance the C1 platform for pharmaceutical applications. The Company has recently achieved commercialization of certain recombinant protein products through a combination of partner collaborations and internal production activities, including the launch of AlbuFree™ DX recombinant human albumin by Proliant Health and Biologicals and recombinant DNase I through Dyadic’s collaboration with Fermbox Bio (“Fermbox”), which is now available for research and molecular biology applications
Effective August 1, 2025, the Company began doing business as Dyadic Applied BioSolutions. This rebranding reflects the Company’s strategic transition toward a commercially focused biotechnology company delivering applied protein and enzyme solutions through its patented and proprietary Dapibus™ and C1 gene expression platforms.
Platform Capabilities
Dyadic’s Dapibus™ and C1 production platforms are engineered microbial expression systems designed to produce recombinant proteins optimized for high-yield, low-cost, and scalable protein production. These platforms combine advanced strain engineering, fermentation optimization, and downstream processing capabilities, including the use of modern genome editing technologies such as CRISPR/Cas9, to support efficient production of proteins across multiple markets. Building on Dyadic’s prior experience in large-scale microbial fermentation, these platforms support applications in:
| ● | Cell culture media (e.g., albumin, transferrin, fibroblast growth factor (“FGF”)) |
| ● | Diagnostics and research reagents (e.g., DNase1) |
| ● | Functional food ingredients (e.g., alpha-lactalbumin, caseins, lactoferrin) |
| ● | Sustainable industrial enzymes (e.g., biomass and pulp/paper enzymes) |
By targeting high-value proteins in expanding non-pharmaceutical markets, Dyadic is building a commercial pipeline that aligns with global trends in sustainability, animal-free manufacturing, and bio-based innovation. Simultaneously, we continue to explore partnering opportunities for the use of our platforms in pharmaceutical development where appropriate.
In 2025, Dyadic entered into a non-exclusive license agreement with ERS Genomics for the use of CRISPR/Cas9 gene editing technology to support strain engineering and production optimization across its microbial expression platforms. Access to CRISPR-based genome editing tools enables the Company to more efficiently modify host strains used in its protein production systems and may support improvements in strain productivity, product quality, and development timelines for recombinant proteins and enzymes developed internally or with partners.
Dapibus™ Protein Production Platform
To accelerate commercialization across its core sectors, Dyadic developed the Dapibus™ platform—a proprietary expression system designed to produce high-value, non-animal proteins and enzymes for non-pharmaceutical markets including life sciences, food and nutrition, and bio-industrial sectors.
Dapibus™ is expected to enable faster development, lower production costs, and simplified regulatory pathways compared to therapeutic biologics, which Dyadic believes will allow it to address growing demand for sustainable, functional ingredients across a range of industries. The Dapibus™ platform supports applications in life sciences, food and nutrition, and bio-industrial sectors.
Dyadic was able to commercialize multiple Dapibus™-enabled products starting in early 2026 through a combination of strategic partnerships and internal manufacturing initiatives.
C1 Protein Production Platform
Dyadic’s proprietary C1 expression system is a patented, thermophilic fungal platform (Thermothelomyces heterothallica fungus) developed for the cost-effective, large-scale production of proteins. Originally used to manufacture industrial enzymes, Dyadic has engineered C1 into a high-yield, scalable platform for biopharmaceutical applications.
Following the 2015 sale of its industrial enzyme business to Danisco USA (a DuPont subsidiary), Dyadic retained co-exclusive rights to the C1 platform for human and animal pharmaceutical use, including the exclusive ability to sub-license C1 for human and animal pharmaceutical use (subject to specific conditions). Danisco holds certain retained rights but is obligated to pay Dyadic royalties on any future pharmaceutical commercialization. Dyadic may owe downstream royalties to Danisco or its licensors depending on specific patent usage.
Strategic Advantages and Applications
C1 is designed to address key bottlenecks in biologics manufacturing, offering potential advantages over legacy systems (e.g., CHO, E. coli, and baculovirus), including:
| ● | High-yield expression of secreted proteins with minimal viscosity and simplified downstream purification. |
| ● | Avoidance of viral and endotoxin removal processes required by mammalian or bacterial systems. |
| ● | Proven scalability across lab and industrial fermenters, with demonstrated success producing correctly folded monoclonal antibodies (“mAbs”) comparable to CHO-derived equivalents. |
C1 is being applied to develop a range of therapeutic and Life Science proteins, including:
| ● | Therapeutics: Vaccines, monoclonal and multi-specific antibodies. |
| ● | Life Sciences: Recombinant transferrin, albumin, fibroblast growth factor (FGF), DNase I, RNase inhibitors, reagents, and enzymes for diagnostics, cell culture, and biopharmaceutical manufacturing. |
Dyadic is engaged in multiple funded collaborations with pharmaceutical and biotech partners exploring C1’s use in innovative diagnostic, vaccine and therapeutic development.
Dyadic believes the C1 platform’s combination of scalability, speed, and efficiency makes it a compelling alternative for global bioproduction—supporting near- and long-term opportunities in both commercial and strategic licensing partnerships.
Pipeline Overview
Dyadic is targeting high-growth, non-pharmaceutical markets with a focus on sustainable, animal-free proteins and enzymes. The Company’s Dapibus™ platform is engineered to deliver cost-effective, scalable production of high-quality proteins for use in life sciences, food and nutrition, and bio-industrial sectors. These markets are experiencing rapid growth driven by the demand for ethical, allergen-free, and environmentally sustainable alternatives to animal-derived ingredients.
Dapibus™ is generating revenue from non-pharma applications and continues to advance through a focused pipeline of commercial-stage and development-stage programs.
Life Sciences
Dyadic is developing and commercializing a portfolio of recombinant proteins and enzymes for life sciences applications, including cell culture media, diagnostics, molecular biology reagents, and bioprocessing inputs. Using its C1 and Dapibus™ protein production platforms, the Company is focused on producing animal-free alternatives to commonly used proteins and enzymes that support research, diagnostics, and biomanufacturing. Several of these products have recently entered commercial launch or early market introduction through partner collaborations and direct product offerings.
Cell Culture Media and Reagent Proteins
Dyadic is leveraging its microbial production platforms to produce high-value, animal-free growth media components used in biopharmaceutical manufacturing, diagnostics, and emerging biotechnology applications.
Recombinant Serum Albumin: In partnership with Proliant Health and Biologicals, Dyadic supported development of AlbuFree™ DX, a recombinant human albumin product produced using Dyadic’s proprietary expression technology. Proliant announced the commercial launch of AlbuFree™ DX in 2026 for research and diagnostic applications. Under the terms of the agreement, Dyadic receives a share of profits from Proliant’s commercial sales of recombinant human albumin products and has received development and milestone payments associated with the program.
Recombinant Transferrin: Dyadic has developed an animal-free transferrin designed for use in cell culture media, diagnostics, and research applications. Early testing has demonstrated performance comparable to commercially available recombinant reference standards. Dyadic is pursuing commercialization through direct sales and distribution partnerships.
Recombinant Fibroblast Growth Factor (FGF): Dyadic has developed recombinant bovine FGF proteins used to support cell proliferation in cell culture systems. Initial evaluation and sampling activities are underway, with early commercial sales initiated in certain research applications.
DNA and RNA Enzymes
Dyadic is expanding its existing product portfolio to include additional enzymes used in molecular biology, diagnostics, and nucleic acid processing applications.
DNase I (RNase-free): Dyadic completed development and production validation of recombinant DNase I used for molecular biology and bioprocessing applications. In March 2026, Dyadic and Fermbox announced the launch of animal-origin-free recombinant DNase I (RNase-free), representing the first commercialized product under the companies’ expanded collaboration.
RNA/DNA Enzyme Portfolio: Dyadic continues development of additional enzymes used for nucleic acid processing, including RNase inhibitors, T7 RNA polymerase, DNA ligase, and polymerases, with ongoing optimization and evaluation for research and diagnostic applications.
Food and Nutrition Applications
Dyadic is developing and supporting commercialization of animal-free dairy proteins and food enzymes through a combination of internal development programs and partner collaborations. Using its Dapibus™ protein production platform, the Company is pursuing opportunities in dairy alternatives, functional nutrition ingredients, and food processing enzymes.
Non-Animal Dairy Enzyme Program: Under a development and exclusive license agreement signed in 2023 with Inzymes ApS, Dyadic has received upfront payment and milestone payments totaling approximately $1.45 million related to development and commercialization achievements. Development activities have been completed, and Inzymes has announced plans to commercialize recombinant non-animal bovine chymosin, a key enzyme used in cheese production and dairy processing, in 2026. Dyadic remains eligible to receive royalties on future commercial sales.
Recombinant Bovine Alpha-Lactalbumin: Dyadic developed an improved first-generation production strain in 2024. The protein has demonstrated comparability to commercial benchmarks and continues to undergo characterization and evaluation for potential applications in dairy alternatives and nutritional products.
Recombinant Human Alpha-Lactalbumin: Development was initiated in 2024 for potential applications in infant formula, medical nutrition, nutraceuticals, and related nutritional products.
Recombinant Human Lactoferrin: Dyadic developed a production cell line in 2024 for potential use in nutritional, antimicrobial, and immune-support applications. Additional optimization and characterization activities are ongoing.
Casein Proteins: Dyadic has produced four recombinant casein variants and continues discussions with potential partners regarding development and commercialization opportunities.
In December 2025, Dyadic entered into a Development and Commercialization Agreement with The Protein Collective B.V. (“BRIG BIO”), a Netherlands-based developer of recombinant dairy ingredients, to jointly develop and commercialize recombinant bovine alpha-lactalbumin. Under the agreement, BRIG BIO will fund development activities and receive a global commercial license to production strains developed using Dyadic’s Dapibus™ expression system. Dyadic is eligible to receive development funding, milestone payments, and revenue participation tied to future commercial sales.
Also in December 2025, Dyadic announced the expansion of its strategic collaboration with Fermbox to support the development, manufacturing, and commercialization of animal-free proteins and enzymes across life sciences, food and nutrition, and bio-industrial markets.
Bio-Industrial Applications
Dyadic is developing and supporting commercialization of industrial enzymes and proteins used in biomass processing, biofuels, and other industrial biotechnology applications. Using its proprietary microbial production platforms, including Dapibus™, the Company collaborates with partners to develop and manufacture enzymes designed to improve process efficiency, reduce costs, and support sustainable industrial production.
A key focus of Dyadic’s bio-industrial efforts is the development and commercialization of enzyme products used to convert agricultural residues and other biomass feedstocks into fermentable sugars for downstream fermentation and bio-based production.
In collaboration with Fermbox, Dyadic developed EN3ZYME™, an enzyme cocktail produced using the Dapibus™ protein production platform that enables the conversion of agricultural residue into fermentable cellulosic sugars. Initial enzyme deliveries have been completed under Fermbox’s purchase orders, and Dyadic participates in commercial sales through a profit-sharing arrangement with Fermbox.
In December 2025, Dyadic and Fermbox announced an expanded strategic collaboration to support the development, manufacturing, and commercialization of additional animal-free proteins and enzymes across life sciences, food and nutrition, and bio-industrial markets. Under the expanded collaboration, the companies intend to leverage Dyadic’s microbial protein production technologies and Fermbox’s fermentation and scale-up capabilities to accelerate commercialization of new products.
Dyadic continues to evaluate additional opportunities for industrial enzymes and related applications, including biomass processing, biofuels, and other industrial biotechnology markets.
Biopharmaceutical Programs and Strategic Platform Validation
While Dyadic is primarily focused on non-therapeutic markets, its C1 platform remains a validated and differentiated solution for biopharmaceutical manufacturing, addressing key industry bottlenecks by reducing costs, shortening development timelines, and enabling high-yield production. The platform continues to attract interest from pharmaceutical companies, contract development and manufacturing organizations (“CDMOs,”), academic institutions, and government agencies for applications including recombinant vaccines and therapeutics (human and animal), biobetters and biosimilars, diagnostic reagents, and difficult-to-express proteins.
Dyadic advances selected biopharmaceutical programs through fully funded collaborations with global health organizations, government agencies, and research institutions. These programs provide non-dilutive funding while validating C1’s capabilities in vaccine and antibody production and supporting broader platform adoption.
| ● | The Gates Foundation (2024 award, ~$3.1 million): Development of C1-produced monoclonal antibodies targeting RSV and malaria for low- and middle-income countries. Dyadic has generated stable production strains, with third-party validation demonstrating binding and neutralization comparable to mammalian-expressed antibodies. |
| ● | Coalition for Epidemic Preparedness Innovations (CEPI) / Fondazione Biotecnopolo di Siena (FBS) – FAST Program (2025, up to ~$2.4 million to Dyadic): Pandemic preparedness initiative focused on rapid development of recombinant protein vaccine antigens, including influenza candidates aligned with CEPI’s 100 Days Mission. |
| ● | European Vaccine Hub (EVH): Participation in a multi-country initiative to strengthen pandemic preparedness and vaccine development infrastructure. |
| ● | NIAID/NIH (LMIV): Successful tech transfer of the C1 platform enabling development of malaria vaccine candidates advancing toward potential clinical selection, with joint engagement with BARDA supporting broader U.S. government adoption. |
| ● | The Scripps Research Institute: Demonstrated expression of structurally correct prefusion RSV antigens with observed immunogenicity in preclinical studies, supporting development of multivalent respiratory vaccine candidates (including RSV, hMPV, and PIV3). |
| ● | Avian Influenza Programs: Successful expression of Clade 2.3.4.4b H5 trimeric antigen under the CEPI/FBS program, currently in preclinical evaluation as a pandemic influenza vaccine candidate, and development of a broad ELISA diagnostic for anti-H5 detection across multiple avian species. |
Additional collaborations further expand evaluation of the C1 platform:
| ● | Uvax Bio: Participation in a CEPI-supported Middle East Respiratory Syndrome coronavirus vaccine program. |
| ● | AdaptVac: Participation in a $12.4 million CEPI-supported filovirus vaccine program. |
| ● | Rabian (EUROSTARS RABIVA consortium): Development of a recombinant rabies vaccine candidate with partners Idevax and Artemis Bioservices; Dyadic holds a minority equity interest and may receive future milestones and royalties. |
Through these programs, Dyadic continues to evaluate licensing, collaboration, and commercialization opportunities, positioning the C1 platform as a competitive alternative to traditional expression systems such as CHO, yeast, and insect cells for biologics manufacturing.
Prior Clinical and Platform Validation
Dyadic previously advanced DYAI-100, a C1-produced COVID-19 vaccine candidate, through a Phase 1 clinical trial, which demonstrated favorable safety and immunogenicity results. While further development of the candidate has been paused, the study provided important clinical validation of the C1 platform for the production of recombinant vaccine antigens.
In addition, multiple peer-reviewed publications and collaborative studies have demonstrated the ability of the C1 platform to produce complex glycoproteins, monoclonal antibodies, and viral antigens with structural and functional properties comparable to proteins produced using mammalian and insect expression systems.
While Dyadic’s near-term commercialization efforts are focused on life sciences, food and nutrition, and bio-industrial markets, these biopharmaceutical collaborations provide continued validation of the C1 platform and may support future pharmaceutical licensing opportunities.
Licensing and Strategic Collaborations
Rubic One Health (South Africa)
In April 2023, Dyadic expanded its license agreement with Rubic to include vaccines and therapeutic proteins for both human and animal health in underserved African markets. The C1 platform tech transfer is complete. Dyadic is eligible to receive milestone payments, royalties, and marketing rights under the agreement. In 2024, Rubic initiated development of several livestock vaccines.
Phibro Animal Health / Abic Biological Laboratories
Dyadic entered an exclusive sublicense agreement with Abic, an affiliate of Phibro Animal Health Corporation, in February 2022. The agreement was expanded in March 2024 to include additional vaccines and treatments for livestock diseases.
Research and Development
Dyadic conducts internal and collaborative R&D to advance its microbial platforms across both pharmaceutical and non-pharmaceutical applications.
VTT Technical Research Centre of Finland
Since 2016, Dyadic has partnered with VTT Technical Research Centre of Finland (“VTT”), a leading European research institute, to enhance C1’s safety, productivity, and efficiency. VTT supports critical initiatives including glycoengineering, protease deletion, and therapeutic protein expression. Many projects at VTT are co-funded by Dyadic’s third-party collaborators.
Other CRO and CDMO Partnerships
Dyadic works with a global network of research providers and manufacturers, including 53Biologics (Spain), Fermbox (India), and Eleszto Genetika (Hungary). These partners support the Company’s R&D and scale-up activities across its platforms. While typically structured as work-for-hire engagements, disruptions to these collaborations could impact timelines or development outcomes.
Advancing the Dapibus™ Platform for Scalable Commercial Applications
Dyadic continues to enhance the Dapibus™ platform to meet growing demand for cost-effective, scalable protein production across non-pharmaceutical markets—including dairy, biofuels, biogas, biorefining, and alternative proteins. In collaboration with Eleszto Genetika and leading contract research organizations, key initiatives include:
| ● | Engineering new Dapibus™ strains tailored to specific industrial applications. |
| ● | Improving genetic tools to accelerate development and boost protein expression. |
| ● | Reducing background protease activity to increase stability, yields and product quality. |
| ● | Optimizing fermentation and purification processes to lower cost of goods sold. |
| ● | Developing high-expression cell lines to support large-scale commercial production. |
Demonstrating C1’s Biopharmaceutical Capabilities
In parallel, Dyadic continues to validate the C1 platform for biopharmaceutical applications with key partners such as VTT. Notable advancements include:
| ● | The development of high-yield production strains of human and bovine serum albumin, vaccine antigens (i.e., SARS CoV-2, Spike HA, NA, Mpox), and a number of complex biologics (ferritin nanoparticle antigens, scFvs, mAbs, Fc-fusions). |
| ● | VTT developed the initial C1 cell line used in the successfully completed DYAI-100 SARS-CoV-2 vaccine Phase 1 clinical study. |
| ● | mAbs produced in C1 showing comparable binding kinetics and glycosylation profiles to CHO cell-derived antibodies. |
| ● | Third-party validation of neutralizing and binding activities for C1-expressed antibodies and multi-specific biologics. |
These efforts position Dyadic’s platforms as versatile, low-cost solutions for both industrial and therapeutic protein markets, expanding commercial potential across multiple verticals.
Our Market Opportunity
Given the versatility of our robust portfolio of recombinant proteins that we expect to launch in the next two years, we believe that we are well-positioned to pursue a combined total addressable market of approximately over $25 billion across life sciences, food and nutrition, and bio industrial segments. The estimated total addressable market for our current recombinant solutions portfolio is comprised of opportunities in the following areas:
Life Sciences
Our products are being commercialized through a combination of direct product sales, distribution agreements, and manufacturing collaborations with companies that have established market access and distribution capabilities.
Cell Culture Media: Approximately $5 billion global market. We define total addressable market as approximately $2 billion global revenue opportunity for our recombinant solutions within the albumin, transferrin and growth factors markets. This was calculated using publicly available third-party data to estimate the recombinant protein shares for these products within the global cell culture media market. We will seek to serve the Cell Culture Media market, direct sales and OEM supply agreements for our recombinant cell culture media solutions, such as transferrin and growth factors to third-party manufacturers, distributors, repackagers and strain/platform licensing agreements key strategic partnerships with companies operating within the cell culture media space such as our commercial agreement with Proliant Health and Biologics to produce and commercialize recombinant human albumin.
Molecular Biology Reagents: Approximately $2 billion. We define total addressable market as the global revenue opportunity for our molecular biology reagents and recombinant DNase solutions in life science research. This was calculated using publicly available third-party data to estimate the recombinant protein shares for these products within the molecular biology reagent market. We will seek to serve the molecular biology reagent market through strain/platform licensing agreements, direct sales and OEM supply agreements for our recombinant molecular biology reagent solutions, such as DNASE-1 and others to third-party manufacturers, distributors, and repackagers.
Food and Nutrition:
The Company is pursuing opportunities in proteins used in infant nutrition, dairy alternatives, and other nutritional applications, as well as enzymes used in dairy processing, baking, brewing, and other food manufacturing processes.
Certain collaborations may include development funding, milestone payments, annual licensing fees, and potential revenue participation from commercial product sales.
We define total addressable market of approximately $11 billion as the global revenue opportunity for our recombinant solutions within the dairy protein, alpha-lactalbumin and functional proteins and dairy enzymes markets. This was calculated using publicly available third-party data to estimate the recombinant protein shares for these products within the Food and Nutritional market. We will seek to serve the Food and Nutrition market through direct sales and OEM supply agreements for our non-animal dairy, research products and other solutions to third-party manufacturers, distributors, repackagers and key strain/platform licensing agreements with strategic companies operating within the Food and Nutrition segment, such as our commercialization agreement with Inzymes to produce non-animal dairy enzymes markets.
Bio-Industrial:
Dyadic collaborates with partners to develop and commercialize industrial enzymes used in applications such as biomass processing, biofuels production, and other industrial biotechnology markets. These collaborations may include manufacturing agreements, supply arrangements, or revenue-sharing structures for enzymes produced using Dyadic’s microbial production platforms. We define total addressable market of approximately $6 billion as the global revenue opportunity for our recombinant bio-industrial protein and enzyme solutions within, biofuels pulp, paper, textiles, cosmetics solutions and other applications. This was calculated using publicly available third-party data to estimate the recombinant protein shares for these products within the cellulosic Bio Industrial market. We will seek to serve the Bio-Industrial market through direct sales and OEM supply agreements for our biomass processing and other solutions to third-party manufacturers, distributors, repackagers and key strain/platform licensing agreements, with strategic companies operating within the Bio-Industrial markets, such as our commercialization agreement with Fermbox to produce cellulosic enzyme solutions for biomass processing. We believe we can leverage our proprietary microbial platforms, C1 and Dapibus™, as well as our growing portfolio of high-value input proteins to target these markets. For additional information, see “—Our Pipeline.”
Platform Strengths and Competitive Positioning
Dyadic’s proprietary C1 and Dapibus™ platforms are designed to offer a scalable, cost-effective alternative to traditional protein production systems across pharmaceutical and non-pharmaceutical applications. These platforms are engineered to produce vaccines, antibodies, enzymes, and nutritional proteins with greater efficiency, shorter development timelines, and lower cost of goods.
Compared to legacy expression systems, Dyadic’s platforms offer the following potential advantages:
| ● | CHO Cells (Mammalian): Industry standard for complex biologics but limited by long development cycles, high production costs, and complex purification requirements. |
| ● | E. coli (Bacterial): Fast and inexpensive, but often produces insoluble proteins requiring refolding and generates pyrogenic contaminants, limiting use in biologics and precision food applications. |
| ● | Yeast (e.g., Pichia pastoris): Lacks pyrogenic components and offers advanced genetic tools but can exhibit undesirable glycosylation and lower expression for certain targets . |
| ● | Insect Cells (Baculovirus): Used for vaccines and post-translational modifications but generally produce lower protein titers and require viral inactivation steps, adding time and cost. |
| ● | Filamentous Fungi: Aspergillus, Trichoderma which are commonly used in industrial enzyme production, less advanced for pharmaceutical proteins. |
Dyadic believes C1 and Dapibus™ combine the scalability of microbial systems with the productivity and versatility needed to serve diverse end markets—positioning the Company as a next-generation platform provider in the global protein production landscape.
Competition
We operate in highly competitive and rapidly evolving sectors that include biotechnology, life sciences, food and nutrition, and industrial bioprocessing. Our proprietary C1 and Dapibus™ microbial expression platforms are designed to offer cost-effective, scalable alternatives to traditional protein production systems. While we believe our platforms provide certain unique advantages in terms of yield, speed, and versatility, we face competition from both established and emerging players across our target markets.
In life sciences applications such as cell culture media components (e.g., albumin, transferrin, and growth factors) and molecular biology reagents (e.g., DNase, RNase inhibitors, and polymerases), we compete with many companies using mammalian (CHO), bacterial (E. coli), yeast, and insect cell expression systems. These technologies are well established and supported by large, well-capitalized organizations, which may enable them to commercialize competing products more rapidly or at greater scale than we can achieve initially.
In food and nutrition markets—including functional dairy proteins and non-animal enzymes—competition is intensifying due to the rise of precision fermentation and synthetic biology platforms. Several companies are actively developing recombinant proteins such as caseins, whey components, and bioactive peptides for use in dairy alternatives, infant nutrition, and wellness applications. While these markets present significant growth opportunities, many participants benefit from strong funding, strategic partnerships, and first-mover advantages.
In the bio-industrial segment, we face competition from multinational enzyme producers and microbial fermentation companies developing enzymes for applications such as biomass conversion, pulp and paper, and biofuels. Our strategy to collaborate with commercial partners, such as Fermbox, is intended to accelerate market entry and reduce capital intensity, but competitors may leverage larger sales networks and existing customer relationships.
There are a number of companies commercializing a diversified portfolio of non-animal recombinant proteins using yeast (i.e.,Pichia andSaccharomyces) and to a lesser extent filamentous fungal (i.e.,Aspergillus &Trichoderma) platforms. Given the pace of innovation and increasing interest in sustainable bioproduction, it is likely that existing or new competitors could develop similar capabilities or adopt comparable strategies in the future.
Additionally, academic institutions, contract development and manufacturing organizations (CDMOs), and government-funded initiatives may contribute to increased competition by advancing alternative production technologies or partnering with industry participants to bring new solutions to market.
Despite the competitive landscape, we believe our platforms offer certain compelling differentiation due to their scalability, productivity, cost efficiency and glycan profiles. However, there can be no assurance that we will be able to compete successfully against current or future competitors, or that advancements by others will not render our technologies or product candidates obsolete or non-competitive.
Government Regulation and Product Approval
As a small biotech company that operates in the United States, we are subject to extensive regulation. Government authorities in the United States (at the federal, state and local level) and in other countries extensively regulate, among other things, the research, development, testing, manufacturing, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing and export and import of drug products such as those we are developing. Product candidates that we develop must be approved by the FDA, before they may be legally marketed in the United States and by the appropriate foreign regulatory agency before they may be legally marketed in foreign countries. Generally, our activities in other countries will be subject to regulation that is similar in nature and scope as that imposed in the United States, although there can be important differences. For additional discussion on the effect of existing or probable governmental regulations on our business, see “Item 1A. Risk Factors—Risks Related to Government Regulations and Environmental, Social, and Governance Issues.”
Employees
As of December 31, 2025, the Company had 5 full-time employees, all of whom are located in the United States.
Intellectual Property
Patents are important to developing and protecting our competitive position. Our general policy is to seek patent protection in the United States, major European countries, and other jurisdictions as appropriate for our compounds and methods. U.S. patents, as well as most foreign patents, are generally effective for 20 years from the date the earliest patent application was filed. In some cases, the patent term may be extended to recapture a portion of the term lost during the U.S. FDA regulatory review or because of U.S. Patent and Trademark Office (“USPTO”) delays in prosecuting the application. The duration of foreign patents varies similarly, in accordance with local law.
Currently, Dyadic owns or has exclusive rights to six (6) patent families, all of which have entered the national phase. There are currently two (2) patents and four (4) pending patent applications in the United States, one patent in Russia, one patent in South Africa, and twenty-eight (28) additional patent applications in a variety of jurisdictions including Europe and China.
Our success is significantly dependent on our ability to obtain and maintain patent protection for C1 and Dapibus™, both in the United States and abroad. Our patent position and proprietary rights are subject to various risks and uncertainties. Please read the “Item 1A. Risk Factors” of this Annual Report for information about certain risks and uncertainties that may affect our patent position and proprietary rights.
We also rely upon unpatented confidential information to remain competitive. We protect such information principally through confidentiality agreements with our employees, consultants, outside scientific collaborators, and other advisers. In the case of our employees, these agreements also provide, in compliance with relevant law, that inventions and other intellectual property conceived by such employees during their employment shall be our exclusive property.
Available Information
Information that we furnish to or file with the Securities and Exchange Commission (the “SEC”), including the Company’s annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and any amendments to, or exhibits included in, these reports are made available for download, free of charge, through the Company’s website at www.dyadic.com as soon as reasonably practicable. The Company’s SEC filings, including exhibits filed therewith, are also available directly on the SEC’s website at www.sec.gov.
The Company may use its website as a distribution channel of material company information. Financial and other important information regarding the Company is routinely posted on and accessible through the Company’s website. Accordingly, investors should monitor this channel, in addition to following the Company’s press releases, SEC filings and public conference calls and webcasts. Information contained on the Company’s website is not part of this report.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.