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Item 1. Business

2026-03-25 compared with 2025-03-26 · 478 added, 276 removed, 4 unchanged (99% of the section changed)

Dyadic International, Inc.

(“Dyadic”, “we”, “us”, “our”, or the “Company”) is a global biotechnology platform company based in Jupiter, Florida with operations in the United States and a satellite office in the Netherlands, and it utilizes several third-party consultants and contract research organizations to carry out the Company’s activities.

Over the past two plus decades, the Company developed a gene expression platform for producing commercial quantities of industrial enzymes and other proteins, and previously licensed this technology to third parties, such as Abengoa Bioenergy SA, BASF SE, Codexis, Inc.

and others, for use in industrial (non-pharmaceutical) applications.

This technology is based on the Thermothelomyces heterothallica (formerly known as Myceliophthora thermophila ) fungus, which the Company named C1.

For the past nine years since the Company sold its industrial technology business to Danisco USA (“Danisco”), the industrial biosciences business of DuPont (NYSE:

DD) (the “DuPont Transaction”), the Company has been 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 and for other biologic products for use in non-pharmaceutical applications.

As part of the DuPont Transaction, Dyadic retained co-exclusive rights to its proprietary and patented C1 protein production platform (the “C1 platform”) for use in all human and animal pharmaceutical applications, and currently, the Company has the exclusive ability to enter into sub-license agreements (subject to the terms of the license and to certain exceptions) for use in all human and animal pharmaceutical applications.

Danisco retained certain rights to utilize the C1 platform in pharmaceutical applications, including the development and production of pharmaceutical products, for which it will be required to make royalty payments to Dyadic upon commercialization.

In certain circumstances, Dyadic may owe a royalty to either Danisco or certain licensors of Danisco, depending upon whether Dyadic elects to utilize certain patents either owned by Danisco or in licensed by Danisco.

After the DuPont Transaction, the Company has directed its efforts toward advancing the C1 platform to address the increasing global demand for the development and manufacturing of prophylactic and therapeutic biopharmaceuticals for human and animal health.

The Company’s biopharmaceutical development efforts have been centered on enhancing the capability of the C1 platform to produce stable, properly folded, and functional proteins for pharmaceutical applications, including vaccines and monoclonal antibodies.

In addition to improving the quality and productivity of the C1 platform, the Company has sought to validate its platform for human use through a series of fully funded biopharmaceutical projects, extensive animal studies utilizing C1-produced proteins, and in 2024, the successful completion of a Phase 1 first-in-human study for a vaccine antigen produced using C1, which demonstrated its safety for human applications.

Recognizing the longer development timelines, clinical testing, and regulatory requirements associated with human and animal pharmaceutical products, the Company has refined its core business strategy to expand into recombinant (non-animal derived) alternative proteins for non-pharmaceutical applications in research, nutrition, and industrial markets.

To address these opportunities, the Company has developed and launched the Dapibus™ Protein Production Platform (“Dapibus™”), which supports various applications within the alternative proteins field, namely in Life Sciences, Food & Nutrition, and Bioindustrial applications.

Given the reduced developmental costs, shorter timelines, and fewer regulatory requirements associated with alternative proteins, Dapibus™ has enabled the Company to generate near-term recurring revenue while continuing to build long-term value through C1 for pharmaceutical applications.

The Company anticipates achieving commercialization of certain alternative protein products in 2025 through a combination of existing collaborations and internal manufacturing efforts.

Dyadic Protein Production Technology

The Company is focused on utilizing its proprietary, highly productive, and scalable microbial fungal protein production platforms C1 and Dapibus™ to address the increasing global demand for non-animal-derived proteins in both pharmaceutical and non-pharmaceutical applications.

By applying its industrially validated, efficient, and cost-effective bioproduction technology to high-value markets such as human therapeutics and alternative food and nutrition, the Company aims to facilitate the rapid development and large-scale manufacturing of proteins, enzymes, and other biologic products.

Through targeting key products within its core business segments, the Company seeks to address global health and nutrition challenges by providing innovative, accessible, and economically viable solutions.

C1 is a versatile thermophilic filamentous fungal expression system customized for the development and production of biologic products including enzymes and other proteins for human and animal health that may offer potential competitive advantages compared to certain other legacy biopharmaceutical expression systems in the discovery, development, and cost-effective manufacturing of biologic medicines and vaccines.

Potential applications to be produced from C1 include protein antigens, ferritin nanoparticles, virus-like particles (“VLPs”), monoclonal antibodies (“mAbs”), Bi/Tri-specific antibodies, Fab antibody fragments, Fc-fusion proteins, as well as other therapeutic enzymes and proteins.

The Company participates in multiple funded research collaborations with certain leading animal and human pharmaceutical companies.

These partnerships are strategically engaged to leverage the potential of C1 in the development of innovative vaccines and drugs, as well as biosimilars and/or biobetters, which we believe will contribute to advancements in medical science and healthcare.

The Company believes C1 possesses unique characteristics that distinguish it from conventional filamentous fungal cells.

C1 offers potential competitive advantages in the discovery, development, and manufacturing of biologic medicines and vaccines compared to certain legacy biopharmaceutical expression systems.

It allows for streamlined purification processes, retaining target secreted proteins efficiently through downstream processing without the need for viral (e.g., CHO (Chinese Hamster Ovary) and Baculovirus) or endotoxin (e.g., E.

coli) removal.

The platform also demonstrates high productivity, thriving under robust and versatile growth conditions while yielding large amounts of secreted protein with low viscosity due to C1’s unique morphology.

Its robustness has been proven across scales, from laboratory microtiter plates and shaker flasks to single-use and stainless-steel microbial fermenters, producing stable, correctly folded mAbs with properties comparable to CHO-produced mAbs.

Dapibus™ holds similar promise for cost-effective production of traditionally costly recombinant and animal derived proteins and enzymes such as serum albumin and dairy proteins.

Dapibus™ is designed to enable the rapid development and large-scale manufacture of cost-effective enzymes, proteins, metabolites, and other biologic products for non-pharmaceutical applications, including food, nutrition, and wellness.

This platform enables streamlined purification processes, ensuring strong retention of the target secreted protein through downstream processing, with no requirement for endotoxin (e.g., E.

coli) removal.

It also boasts high productivity, supporting robust and versatile growth conditions that yield large amounts of secreted protein, while its unique morphology maintains low viscosity at large scales.

Additionally, Dapibus™ demonstrates exceptional robustness, with proven scalability from laboratory microtiter plates and shaker flasks to single-use and industrial-scale stainless-steel microbial bioreactors.

Furthermore, it enables the production of glycosylated proteins, expanding its versatility for various biologic applications.

The Company believes that C1 and Dapibus™, have significant potential to become an alternative to several traditional production technologies currently used in pharmaceutical and non-pharmaceutical applications to produce antigens for use in vaccines, monoclonal antibodies, therapeutic proteins, reagents, food, and nutritional proteins The Company’s platforms have some inherent benefits and potential competitive advantages compared to CHO cells, E.

coli , Pichia pastoris , and Insect Cells (i.e., Baculovirus) as discussed below:

Mammalian cells:

Currently the preferred production host for most complex protein therapeutics due mainly to their ability to produce proteins with human-like glycosylation and regulatory acceptance.

This market is dominated by CHO cells.

Disadvantages include the longer duration required for cell line development, fermentation, and increased costs associated with production media and longer and more costly downstream processing steps.

Bacteria such as E.

coli are currently an easy, inexpensive, and rapid method for recombinant protein expression often used in laboratory settings as well as commercial production of certain non-glycosylated proteins.

However, bacterial platforms produce toxic and pyrogenic cell wall components that may make them less suitable for the production of biopharmaceuticals or other alternative proteins.

Moreover, insoluble expression, a frequent outcome in bacterial expression, is challenging with regard to cost of goods due to the need for refolding and its direct impact on reduced overall yields and resultant waste streams.

In contrast to bacteria, yeast, such as Pichia pastoris , do not produce potentially toxic and pyrogenic cell wall components.

Moreover, the genetic tools for yeast production are advanced and enable continued engineering of new strains that may become more suitable than CHO cell lines.

Disadvantages include lower protein production of select targets and traditional yeast cells have a greater number of higher N and O glycosylation structures.

Insect cells:

Insect cells (i.e., Baculovirus) offer protein expression with post-translational modifications like mammalian cells, ease of scale-up, and simplified cell growth readily adapted to high-density suspension culture for large-scale expression.

Baculovirus expression systems are used for producing recombinant protein, especially for vaccine antigens.

Disadvantages include lower protein titers when compared to other platforms and the need for an additional viral inactivation step.

One of the leading filamentous fungal platforms for bioindustrial and food protein production.

Disadvantages may include a high level of extracellular proteases, which can degrade recombinant proteins and lower expression levels for heterologous proteins compared to other systems.

The biotechnology industry is intensely competitive.

The continuous demand for innovation, efficiency, and speed creates opportunities for the advantages of Dyadic’s C1 and Dapibus™ platforms, however, as the Company’s target markets evolve, there is always the risk that a competitor may be able to develop other technologies that are able to achieve similar or better results.

Currently, we are not aware of other companies pursuing a business model similar to what we are developing with our protein production platforms.

However, our competitors using other protein production platforms who are significantly larger and better capitalized, could potentially adopt similar strategies and implement them at a faster pace.

These potential competitors include multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies, universities, governmental agencies, and other research institutions that are in the operating pharmaceutical sector.

Moreover, smaller or early-stage companies may emerge as significant competitors, particularly through collaborative arrangements with large, established companies.

In non-pharmaceutical applications, several other companies have and are actively engaged in utilizing filamentous fungal microorganisms for the development and manufacture of low-cost proteins, metabolites, and other biological products for use in food, nutrition, and wellness.

Our Industry and Potential Markets

Non-Pharmaceutical Applications

The demand for non-animal-derived enzymes and proteins is rapidly increasing across various industries, driven by advancements in biotechnology, sustainability initiatives, and evolving consumer preferences.

In the reagents sector, non-animal derived proteins are being utilized in diagnostic applications, research tools, and industrial processes, offering a sustainable and ethically responsible alternative to traditional animal-derived proteins.

Within the food industry, the shift toward plant-based and fermentation-derived proteins is accelerating as consumers seek sustainable, allergen-free, and ethically sourced protein alternatives.

Additionally, the alternative protein market—including cell-cultured, microbial, and precision fermentation-derived proteins—is experiencing significant growth as companies strive to meet the rising demand for environmentally friendly scalable, and sustainable protein solutions.

The Company believes that Dapibus™ is well-positioned to address these expanding markets by providing cost-effective, scalable, and high-quality non-animal proteins for use in reagents, food, and other alternative protein applications.

Dapibus™ has begun to generate revenue within non-pharmaceutical applications and the Company has selectively focused on these rapidly growing markets and prioritized our commercial focus accordingly.

Cell culture media products:

A nutrient-rich solution designed to support the growth, maintenance, and proliferation of cells tailored to specific cell types within alternative protein, research or biopharmaceutical applications.

DNA/RNA manipulation products:

Reagents used in the modification, amplification, sequencing, and analysis of DNA and RNA for gene editing, MRNA, and other synthetic biology applications, serving research, diagnostics, biopharmaceutical, and agricultural biotechnology sectors.

Non-Animal dairy protein and enzyme products:

Proteins and enzymes produced through fermentation, precision fermentation, or plant-based processes to replicate the functional and nutritional properties of traditional dairy components catering to the sustainable and animal-free dairy alternatives market

Bioindustrial protein and enzyme products:

Proteins and enzymes used to enhance process efficiency, sustainability, product performance and reduce reliance on harsh chemicals for applications like food/feed additives, biomass conversion, fiber modification, and eco-friendly textile processing.

As demand for more sustainable products in the alternative proteins segment grows, we believe recombinant protein and enzyme products offer clear advantages in overcoming cost, purity, and consistency challenges.

By enabling scalable and controlled production, recombinant technologies reduce reliance on animal-derived or chemically synthesized alternatives while improving efficiency and performance.

These benefits position recombinant enzyme and protein solutions as key enablers in the expansion of sustainable reagent, food, nutrition, and industrial applications.:

Reagents & Biotech – Affordable recombinant enzymes and proteins enhance molecular biology workflows, diagnostics, and biopharmaceutical research.

Nutritional & Food Ingredients – Lower production costs enable widespread adoption of recombinant dairy proteins, alternative meats, and functional food enzymes, meeting the rising demand for non-animal and precision-fermented ingredients.

Industrial Applications – Economically viable recombinant enzymes facilitate greener, more efficient bioprocessing in biofuels, biogas, textiles, pulp and paper, and waste management, displacing conventional chemical-intensive methods.

Consistency & Purity – Recombinant production enables high batch-to-batch consistency with minimal variability, reducing impurities and contamination risks compared to animal-derived or chemically synthesized alternatives.

The Company believes Dapibus™ unlocks significant market opportunities within the alternative proteins segment by addressing key challenges related to cost, scalability, and quality.

By leveraging the platform to produce cost-effective, high-quality non-animal derived proteins for non-pharmaceutical applications, the Company can capitalize on near-term revenue opportunities.

These applications benefit from shorter commercialization timelines, lower development costs, and a more streamlined regulatory pathway compared to pharmaceutical products, accelerating market entry and adoption.

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.

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.

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.

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.

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.

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

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.

Based on feedback received from our collaborators and our ongoing discussions with leading pharmaceutical and biotechnology companies, contract manufacturing organizations, leading academic institutions, as well as U.S.

and foreign governmental agencies, we believe that the biopharmaceutical market remains an attractive opportunity to apply C1.

The Company continues to evaluate potential opportunities to expand the application of C1, and is currently focused on the following markets:

Recombinant vaccines and drugs for animal and human health

New innovative biotherapeutics

Biosimilars / Biobetters non-Glycosylated/Glycosylated protein markets

Drug formulation, research diagnostic and reagents

The demand for biologic medicines, including infectious disease vaccines and therapeutics, has grown significantly in the post-COVID-19 healthcare landscape.

However, access to these medicines remains limited due to high costs for both patients and healthcare systems.

The Company believes that these challenges are, in part, the result of key bottlenecks in the development and manufacturing of biologic medicines, including:

Extended timelines for stable cell line development and manufacturing

Insufficient titers and overall yields

High production costs, due to expensive media and other consumables

Long production cycles for stable mammalian and insect (i.e., baculovirus) cell lines

Historically underfunded development of more efficient next-generation protein production systems

The Company believes that the biopharmaceutical industry would benefit from an innovative protein production platform that is safe, efficient, reliable, and cost-effective.

Such a platform could enable the rapid and high-titer production of difficult-to-express proteins, improving patient access and reducing costs.

The Company’s C1 platform has the potential to serve as an alternative to CHO, insect cells (i.e.

Baculovirus), yeast and other traditional expression systems for the production of proteins used in vaccines, therapeutics, diagnostics, and other biologic products.

Our Research Partners and CROs

Currently, the Company is conducting its C1 research and other internal and external third-party programs with several contract research organizations as follows:

Research and Development Agreement with VTT Technical Research Centre of Finland, Ltd

Since September 2016, the Company has been working with VTT Technical Research Centre of Finland, Ltd.

(“VTT”), a third-party contract research organization, to further modify and improve C1 to ensure a safe and efficient expression system for use in accelerating development and lowering the cost of manufacturing pharmaceutical and non-pharmaceutical products and processes.

VTT is one of the leading research and technology organizations in Europe, and it has conducted research and development on fungi and other microorganisms for more than three decades.

VTT is continuing their development work to further develop C1.

The Company has extended its research contract with VTT multiple times to continue developing C1 for therapeutic protein production, including C1 host system improvement, glycoengineering, protease deletion, and management of third-party target protein projects.

A significant portion of the research and development activities at VTT are being funded by the Company’s third-party collaborators.

Other CROs and cGMP Manufacturers

The Company works with several other research providers, cGMP manufacturers, and contract research organizations from time to time, which are important to achieve the Company’s scientific and business objectives.

These entities include but are not limited to 53Biologics (Valladolid, Spain), Fermbox Bio (Bangalore, KA, India), and Eleszto Genetika (Budapest, Hungary).

These arrangements are typically work for hire on an as-needed basis;

however, certain of these programs, if negatively impacted due to resource availability, disagreements, or other reasons could lead to delays or inability to realize our research and commercial objectives.

Our Research and Development ( “ R&D ” ) Programs

Internal Research Programs

Production Host Improvements:

The Company continued to invest in and advance Dapibus™.

In conjunction with Eleszto Genetika (“EG”), our internal and third party research and development initiatives are focused on both enhancing the robustness, versatility, and efficiency of Dapibus™ and developing new Dapibus™ production strains for a range of non-pharmaceutical applications—including dairy, biofuels, biogas, biorefining enzymes, and alternative proteins.

Key ongoing research and development projects include, but are not limited to, the following:

Continued development and refinement of Dapibus™ to enhance overall robustness, versatility, and efficiency.

Generation of Dapibus™ production strains specifically engineered for applications in dairy processing, biofuels, biogas, biorefining enzymes, and alternative protein production.

Ongoing improvement of genetic engineering tools to accelerate strain development and optimize expression profiles.

Identification and targeted deletion of background protease genes to further reduce proteolytic activity, thereby improving yield and product quality.

Modification and refinement of both fermentation protocols and downstream purification processes to increase production efficiency and reduce cost of goods.

Development of high expression Dapibus™ cell lines through precision engineering techniques to meet the growing demand for cost‐effective protein production.

Execution of a range of analytical methods and quality assessments to ensure that the developed strains and processes meet stringent performance and regulatory standards

The Company collaborates with VTT, Eleszto Genetika, and other CROs and technical service providers to enhance C1 for greater robustness, versatility, and efficiency in protein production.

Key initiatives include improving C1 genetic tools, reducing background protease levels, precision engineering high-expression C1 cell lines, developing C1-expressed vaccine and drug candidates, and glycoengineering C1 cells for mammalian-like glycosylation.

Recent advancements demonstrate the platform’s capability to produce properly folded, biologically active proteins:

Expansion of the platform for human and bovine serum albumin and other recombinant proteins for therapeutic, drug formulation, research, and diagnostic applications.

Further development of DYAI-100 (SARS-CoV-2 RBD) vaccine candidate, including multivalent antigen expression to align with FDA recommendations for annual SARS-CoV-2 vaccines.

High-yield production of SARS-CoV-2 Full Spike Protein, hemagglutinin (HA), and neuraminidase (NA), with demonstrated safety and efficacy in animal trials, including an Oslo University challenge study for influenza.

Expression of complex proteins, including conjugated antigens, scFv (MHCII), and trimerization domains to enhance efficacy.

Successful monoclonal antibody (mAb) production, with C1produced mAbs showing binding kinetics virtually identical to CHO-produced mAbs.

Glycoengineering of C1 cells to produce mAbs with human-like glycan structures and third-party validation of C1-produced mAbs' neutralizing and binding activity.

Production of bi-specifics, tri-specifics, and Fc-fusion proteins at high yields and quality, with C1produced bi-specific antibodies demonstrating similar dose-response activity to CHO produced proteins.

Glycosylated Therapeutic Programs:

The Company aims to leverage its C1 platform for the large therapeutic glycoprotein market, requiring further investment in time and capital.

Advances in genomics and synthetic biology support the engineering of C1’s glycosylation pathways to:

(i) produce therapeutic proteins with human-like glycoforms (G0, G2, G0F, G2F), (ii) reduce or eliminate O-glycosylation, and (iii) enhance immunogenicity in vaccine applications.

Glycoengineering efforts at VTT are progressing, with early results demonstrating the potential of C1 as a viable platform for glycoprotein production.

The Company is refining approaches to optimize gene expression, aiming to develop stable C1 cell lines capable of producing human-like glycosylated therapeutic proteins at high yields.

Early results confirm that C1-produced Nivolumab exhibits similar glycosylation structures, reinforcing the platform’s potential for manufacturing high-value monoclonal antibodies and glycoproteins for therapeutic and preventative applications.

Non-pharmaceutical Programs

Dapibus™ was developed 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.

We believe the Company’s industrial heritage provides our partners with the ability to move from demonstration to commercial production quickly and efficiently.

The Company is actively utilizing Dapibus™ and other technologies to address the unmet need to reduce the production cost in the global market for non-pharmaceutical recombinant proteins.

Cell Culture Media Products

Recombinant Serum Albumin is a vital cell culture media component that supports cell growth, survival and function for use in cell culture media, diagnostics, and as a stabilizing agent for vaccine production.

The Company’s animal-free recombinant serum albumin projects were initiated in late 2022 using Dyadic pharmaceutical cell lines for use in potential therapeutic, product development, research, and/or diagnostic human and animal pharmaceutical applications.

In June 2024, the Company announced a development and commercialization partnership for recombinant serum albumin with Proliant Health and Biologicals (“Proliant”), a leading supplier of purified proteins for diagnostic, nutrition, and cell culture markets.

Prior to the agreement with Proliant, the Company completed initial testing of its recombinant albumin products with Certificates of Analysis issued demonstrating analytical comparability to reference standards.

In addition, Dyadic’s recombinant bovine albumin demonstrated comparable efficacy in cell proliferation of animal muscle cells to albumin products currently used in the cultured meat industry.

Under the terms of the Proliant Agreement, Dyadic has received an initial upfront payment of $500,000, a second payment of $500,000 for completing the transfer of a Production Strain (as defined in the Proliant Agreement) and will receive a final payment of $500,000 upon the meeting of a certain productivity threshold.

Upon commencing commercial sales of animal-free recombinant serum albumin products produced pursuant to the Proliant Agreement, the Company will receive royalties based on a certain percentage of the gross margin received by Proliant, as defined in the Proliant Agreement.

Proliant is progressing toward an expected commercial launch in 2025 as a key component of cell culture media.

In March 2024, the Company entered into a co-promotion agreement with Biftek Co.

for the promotion of growth media supplement for cell culture.

In 2024, the Company began a development program to produce recombinant transferrin for use in cell culture media and other applications.

Dyadic's recombinant transferrin is an animal-free alternative to serum-derived transferrin for use in cell culture media, diagnostic, research, and biopharmaceutical applications.

The Company has completed the initial analysis of its recombinant transferrin product and has Certificates of Analysis for recombinant bovine transferrin that demonstrate comparability to reference standards used in the testing.

In addition, the Company’s recombinant transferrin demonstrated comparable performance to a recombinant reference standard, highlighting its potential as a high-quality, cost-effective non-animal alternative for research and commercial bioprocessing applications.

In 2024, the Company conducted a development program to produce recombinant bovine fibroblast growth factor (“FGF”) for use in cell culture media and biopharmaceutical applications.

As a critical driver of cell growth and proliferation, recombinant FGF plays an essential role in biomanufacturing, regenerative medicine, and cell-based therapies, particularly in serum-free and chemically defined cell culture media.

Initial testing of the Company’s recombinant FGF demonstrated comparability to reference standard for use in cell culture media to proliferate animal muscle cells for the cultured meat industry.

In addition to further characterization and validation efforts, sampling initiatives are expected to begin in Q2 2025.

The Company is currently providing samples of its recombinant cell culture media products such as transferrin and FGF for application testing as growth media for the biopharmaceutical and cultured meat industries in conjunction with ongoing protein characterization testing.

Non-animal Dairy Products

In September 2024, the Company received a milestone payment of $425,000 for achieving the specified target yield of a recombinant diary enzyme, which is expected to be commercialized in late 2025 or early 2026.

This milestone is in addition to the upfront payment of $600,000 received in 2023 when the Company entered a development and exclusive license agreement to commercialize certain non-animal dairy enzymes used in the production of food products using Dapibus™.

In late 2024, the Company developed an improved highly productive strain of recombinant bovine alpha-lactalbumin, a whey protein for the non-animal dairy industry.

Further development has demonstrated Dyadic’s alpha-lactalbumin product is comparable to other recombinant and animal derived products and a Certificate of Analysis has been issued.

In addition to active sampling efforts to interested collaborators, the Company is conducting further characterization of its alpha-lactalbumin product through functional and analytical assays.

In 2024, the Company initiated development of recombinant human alpha-lactalbumin for use in the pharmaceutical, nutraceutical, medical nutrition, and infant formula markets.

In 2024, the Company commenced a recombinant lactoferrin development program and initiated sampling efforts in late 2024.

The Company has developed a cell line to produce stable human recombinant lactoferrin protein for use in research and pharmaceutical applications as potential antimicrobial, anti-inflammatory, and immune-supportive products.

Ongoing optimization and characterization efforts are underway, and the Company expects to begin sampling efforts in 2H 2025.

The Company has produced four casein proteins and is in active discussions with potential collaborators.

Reagent Proteins & DNA/RNA Enzymes

The Company’s DNase-1 product is designed for use in molecular diagnostics, biopharma, and other industries is progressing toward commercial availability.

The Company has completed its development of DNASe-1, and a Certificate of Analysis has been issued for the product.

In addition to exploring licensing opportunities, Dyadic has partnered with an EU-based Contract Development and Manufacturing Organization (“CDMO”) to validate the production process for DNase-1 (RNase-Free) and to produce a research grade DNase-1 product by mid-2025.

Additionally, development efforts have begun to produce research grade DNA/RNA Polymerases, DNA Ligase, and RNase Inhibitor products.

Cell lines have been developed with optimization and analysis ongoing.

The Company has developed prototypes for four additional enzymes, including RNase Inhibitors and T7 RNA Polymerase, to support the growing demand for DNA/RNA manipulation tools.

Development and optimization are ongoing with results expected by the end of 2025.

Bio Industrial Products and Other Products

The Company has developed several enzymes that have the potential for use in multiple industries, such as nutrition, pulp and paper, biogas, biofuels and biorefining.

The Company is actively sampling bio industrial companies.

In 2023, the Company entered into a development and commercialization agreement with Fermbox Bio (“Fermbox”), a synthetic biology research and manufacturing company.

In May 2024, Fermbox announced the launch of EN3ZYME, a cutting-edge enzyme cocktail designed to enhance both the efficiency and cost-effectiveness of transforming pre-treated agri-based residues into fermentable, cellulosic sugars produced using Dyadic’s expression platforms.

In 2024, the Company began development of hyaluronidase, an enzyme that breaks down hyaluronic acid (HA), a key component of the extracellular matrix in connective tissues.

The Company is currently engaging and sampling hyaluronidase to interested parties for a variety of applications such as medical, aesthetic, reproductive, and infectious.

Pharmaceutical Programs

On February 13, 2024, the Company announced a strategic partnership with Cygnus Technologies®, part of Maravai LifeSciences® (Nasdaq:

MRVI), which has developed the C1 Host Cell Protein ELISA Kit for the quality release of products produced using Dyadic’s C1 and Dapibus™ platforms.

The C1 host cell kit is commercially available through Cygnus Technologies (C1 HCP ELISA Kit).

On February 21, 2024, the Company announced it has advanced its collaboration with the Israel Institute for Biological Research (IIBR) and its commercial arm Life Science Research Israel (LSRI), to target emerging disease solutions.

This partnership aims to leverage Dyadic’s expertise in microbial platforms for flexible scale protein bioproduction and the IIBR’s antibodies and antigens discovery capabilities to develop and manufacture innovative solutions for addressing emerging diseases and potential bio-threats.

Through this collaboration, both parties are working towards the development of effective treatments and vaccines to combat global health challenges with the intention of future commercialization (to date, the framework is non-binding and subject to the execution of a binding agreement to be negotiated by the parties) through collaborative out-licensing initiatives.

On February 28, 2024, the Company’s Dutch subsidiary, Dyadic Nederland BV, entered into a strategic partnership agreement and collaboration with Rabian BV (“Rabian”), a Dutch innovative SME founded by experienced entrepreneurs and vaccine scientists.

Awarded by Eurostars for the AVATAR project, a part of the European Partnership on Innovative SMEs, and co-funded by the European Union through Horizon Europe, Rabian will use the total funding leveraging its expertise in virology to develop a rabies vaccine using C1 to tackle the challenges posed by rabies, particularly in lower- and middle-income countries.

Dyadic is expected to receive an equity stake in Rabian, fully funded research and development costs, and specified product milestones and royalties upon commercialization.

In March 2024, a peer-reviewed study on a C1-produced monoclonal antibody was published in Nature Communications.

The study included preclinical trials in non-human primates and hamsters, demonstrating broad neutralization and protection against Omicron (BA.1, BA.2) and earlier COVID-19 variants.

A non-human primate challenge study with the SARS-CoV-2 Delta variant showed promising protection, marking the first validation of a C1-produced monoclonal antibody's safety and efficacy in primates for infectious diseases..

In April 2024, the Clinical Study Report was issued from the Phase 1 study of DYAI-100, a C1-SARS-CoV-2 recombinant protein RBD vaccine candidate and first C1 produced protein tested in humans conducted in collaboration with the Company’s commercialization partner, Rubic One Health.

The study met its primary endpoint demonstrating both the low and high dose levels of the vaccine are safe and well tolerated among participants.

Additionally, the vaccine induced immune responses at both dose levels, suggesting its potential efficacy in generating protective immunity against the target virus.

As the coronavirus has rapidly mutated away from the original strain, Dyadic and its DYAI-100 partner Rubic One Health determined exploring future COVID variants to be more feasible than continuing development of DYAI-100.

Rubic One Health, South Africa

In April 2023, the Company expanded the license agreement with South Africa’s Rubic One Health (“Rubic”) to include vaccines and therapeutic proteins beyond COVID-19 for both human and animal health markets.

This is a collaboration to develop end-to-end solutions to develop, manufacture, commercialize, and distribute affordable vaccines and biologics for human and animal health in underserved African countries.

Tech transfer of the C1 platform has been completed.

Under the license agreement, Dyadic is expected to receive certain marketing rights and other considerations, including milestones and royalty payments, from Rubic.

In 2024, Rubic began development of several livestock animal vaccines for the African market.

Phibro/Abic Sublicense Agreement

On February 8, 2022, the Company entered into an exclusive sublicense agreement with Abic Biological Laboratories Ltd (“Abic”), an affiliate of Phibro Animal Health Corporation (“Phibro”), based on an existing July 1, 2020, non-exclusive sublicense and development agreement (the “Phibro/Abic Agreement”), to provide services for a targeted disease.

On March 15, 2024, the Company expanded its collaboration with Phibro/Abic to develop vaccines and treatments for livestock animal diseases.

Fondazione Biotecnopolo di Siena (FBS)

In 2024, the Company entered a strategic collaboration with Fondazione Biotecnopolo di Siena (FBS), a non-profit foundation backed by the Italian government, including the Ministry of Health, Ministry of Economy and Finance, Ministry of Universities and Research, and Ministry of Enterprise and Made in Italy.

On March 20, 2025, the Company announced that it has received a funding award from CEPI to use C1 to accelerate the development of protein-based vaccines through the partnership with FBS.

Gates Foundation

On November 21, 2024, the Company announced that it has been awarded an approximately $3.0 million grant from the Gates Foundation for the cell line development of mAbs targeting respiratory syncytial virus and malaria utilizing the C1 platform to provide globally accessible treatment options for underserved populations.

C1 produced Ferritin Nanoparticle Vaccines

H5 Avian Influenza (“Bird Flu”) Vaccine Candidate (in collaboration with ViroVax, LLC):

A C1-produced, self-assembling ferritin nanoparticle antigen is under evaluation for diagnostics and vaccines across poultry, cattle, humans, and companion animals to help address the ongoing Bird Flu outbreak.

Pre-commercial research and validation efforts are actively underway to support potential strategic partnerships and licensing opportunities.

Mpox Vaccine Candidate (in collaboration with ViroVax):

A C1-produced ferritin nanoparticle Mpox vaccine candidate is in the early stage of preclinical development.

This project not only would expand our portfolio but also would reinforce the C1 platform’s proven ability to rapidly develop and produce cost-effective recombinant protein vaccine antigens.

Diagnostics & Vaccine Advancements

H5 Avian Influenza Cross-Protection:

The C1-produced adjuvanted ferritin nanoparticle H5-2.3.4.4b A/Astrakhan vaccine candidate has demonstrated cross-protection against multiple H5 virus strains in early-stage research, indicating a broad protective potential.

Poultry & Cattle Applications:

Early trials show that the C1-produced H5-2.3.4.4b A/Astrakhan antigen generates neutralizing antibodies, supporting its potential commercial viability for vaccines and diagnostic tools.

Preliminary diagnostic and vaccine development data suggest promising cross-protection, highlighting a significant opportunity in a broader market segment.

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.

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

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.

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:

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)

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.

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.

Protein Production Platform

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.

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.

Dapibus™ platform supports applications in life sciences, food and nutrition, and bio-industrial sectors.

was able to commercialize multiple Dapibus™-enabled products starting in early 2026 through a combination of strategic

partnerships and internal manufacturing initiatives.

Protein Production Platform

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.

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.

Advantages and Applications

is designed to address key bottlenecks in biologics manufacturing, offering potential advantages over legacy systems (e.g., CHO, E.

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.

is being applied to develop a range of therapeutic and Life Science proteins, including:

Therapeutics:

Vaccines, monoclonal and multi-specific

Life Sciences:

transferrin, albumin, fibroblast growth factor (FGF), DNase I, RNase inhibitors, reagents, and enzymes for diagnostics, cell culture,

and biopharmaceutical manufacturing.

is engaged in multiple funded collaborations with pharmaceutical and biotech partners exploring C1’s use in innovative diagnostic,

vaccine and therapeutic development.

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.

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.

is generating revenue from non-pharma applications and continues to advance through a focused pipeline of commercial-stage and development-stage

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.

Culture Media and Reagent Proteins

is leveraging its microbial production platforms to produce high-value, animal-free growth media components used in biopharmaceutical

manufacturing, diagnostics, and emerging biotechnology applications.

programs include:

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.

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.

and RNA Enzymes

is expanding its existing product portfolio to include additional enzymes used in molecular biology, diagnostics, and nucleic acid

processing applications.

programs include:

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.

and Nutrition Applications

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.

programs include:

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

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.

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.

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

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

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.

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

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.

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

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

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.

programs include:

Foundation (2024 award, ~$3.1 million):

Development of C1-produced monoclonal antibodies targeting RSV and malaria for low- and middle-income

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.

Vaccine Hub (EVH):

Participation in a multi-country initiative to strengthen pandemic preparedness and vaccine development infrastructure.

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.

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

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.

collaborations further expand evaluation of the C1 platform:

Participation in a CEPI-supported Middle East Respiratory Syndrome coronavirus vaccine program.

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;

a minority equity interest and may receive future milestones and royalties.

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.

Clinical and Platform Validation

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.

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.

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.

and Strategic Collaborations

One Health (South Africa)

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.

Animal Health / Abic Biological Laboratories

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.

and Development

conducts internal and collaborative R&D to advance its microbial platforms across both pharmaceutical and non-pharmaceutical applications.

Technical Research Centre of Finland

2016, Dyadic has partnered with VTT Technical Research Centre of Finland (“VTT”), a leading European research institute, to enhance C1’s safety, productivity, and

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.

CRO and CDMO Partnerships

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.

the Dapibus™ Platform for Scalable Commercial Applications

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

parallel, Dyadic continues to validate the C1 platform for biopharmaceutical applications with key partners such as VTT.

Notable advancements

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.

efforts position Dyadic’s platforms as versatile, low-cost solutions for both industrial and therapeutic protein markets, expanding

commercial potential across multiple verticals.

Market Opportunity

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:

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.

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

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.

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.

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.

collaborations may include development funding, milestone payments, annual licensing fees, and potential revenue participation from commercial

product sales.

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 :

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.”

Strengths and Competitive Positioning

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.

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.

coli (Bacterial):

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

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

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.

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.

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.

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.

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.

these markets present significant growth opportunities, many participants benefit from strong funding, strategic partnerships, and first-mover

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.

are a number of companies commercializing a diversified portfolio of non-animal recombinant proteins using yeast (i.e., Pichia

and Saccharomyces ) and to a lesser extent filamentous fungal (i.e., Aspergillus & Trichoderma ) platforms.

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

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.

Regulation and Product Approval

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.”

As of December 31, 2024, the Company had 6 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.

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.

Risk Factors—Risks

Related to Government Regulations and Environmental, Social, and Governance Issues.”

of December 31, 2025, the Company had 5 full-time employees, all of whom are located in the United States.

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.

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 seven (7) patent families, all of which have entered the national phase.

There are currently two (2) patents and six (6) pending patent applications in the United States, one patent in South Africa, and twenty-nine (29) 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.

Patent and Trademark

Office (“USPTO”) delays in prosecuting the application.

The duration of foreign patents varies similarly, in accordance with

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.

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 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.

Please read the “Item

Risk Factors” of this Annual Report for information about certain risks and uncertainties that may affect our patent position

and proprietary rights.

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.

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.

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.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business