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Item 1. Business

2025-03-26 compared with 2024-03-28 · 221 added, 167 removed, 59 unchanged (87% 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 research organizations to carry out the Company’s activities.

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

On December 31, 2015, the Company sold its industrial technology business to Danisco USA (“Danisco”), the industrial biosciences business of DuPont (NYSE:

DD) (the “DuPont Transaction”).

As part of the DuPont Transaction, Dyadic retained co-exclusive rights to the C1-cell protein production 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-cell protein production 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 licensed in by Danisco.

After the DuPont Transaction, the Company has been focused on building innovative microbial protein production platforms to address the growing demand for global protein bioproduction utilizing its advanced microbial platforms to develop and manufacture prophylactic, therapeutic, and nutritional biopharmaceutical products for human and animal health and wellness.

Our Technology

Our mission is to leverage our proprietary highly productive, and scalable microbial fungal protein production platforms to meet the growing demand for proteins in both human and animal health markets worldwide.

Additionally, we aim to enable the rapid development and large-scale manufacturing of cost-effective proteins, metabolites, and other biologic products, extending beyond pharmaceutical applications in areas such as food, nutrition, and wellness.

The C1-cell protein production platform 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.

Potential applications to be produced from C1-cells 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.

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.

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 our C1-cell protein production platform 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 also developed the Dapibus™ thermophilic filamentous fungal-based microbial protein production platform to enable the rapid development and large-scale manufacture of cost-effective proteins, metabolites, and other biologic products for use in non-pharmaceutical applications, including food, nutrition, and wellness.

We believe that our microbial cell line possesses distinctive characteristics compared to conventional filamentous fungal cells.

Moreover, we believe that our protein production platforms offer potential competitive advantages in the discovery, development, and manufacturing of biologic medicines and vaccines, compared to certain other legacy biopharmaceutical expression systems, which include but are not limited to:

High retention of target secreted protein through downstream processing

No requirement for viral (i.e., CHO and Baculovirus) or endotoxin (i.e., E.

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.

High Productivity

Robust and versatile growth conditions High yields of secreted protein

Low viscosity due to C1’s unique morphology

Proven at both small and large scale, ranging from laboratory microtiter plates, shaker flasks, single use and/or stainless-steel microbial fermenters Stable and correctly folded monoclonal antibodies (mAbs), having binding, neutralizing and certain other properties similar to CHO produced mAbs

Develop stable C1-cell lines for protein production in ~ 60 days

Production time savings of ~30 days over CHO-cell production (C1:

12-14 days vs.

CHO 41-54 days) Manufacturing ~ 3-4 batches of C1 produced mAbs in the same time it takes to make 1 batch using CHO-cells

Faster product release –No requirement for viral (i.e., CHO and Baculovirus) or endotoxin (i.e., E.

coli) removal allowing for earlier product release

High yields and rapid manufacturing cycle times reduce costs and shrink manufacturing footprint

C1-cells can be grown using low-cost and readily available cGMP media; C1 media < 1/20 of the cost of CHO cell media

No requirement for viral or endotoxin removal, which simplifies processing compared to CHO, Baculovirus and E.

coli, saving time and money

The biotechnology and biopharmaceutical industry is intensely competitive.

There is continuous demand for innovation and speed, and as the vaccine and therapeutic markets evolve, there is always the risk that a competitor may be able to develop other compounds or drugs that are able to achieve similar or better results for indications.

Potential competition includes major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies, universities, and other research institutions.

Many of these competitors have substantially greater financial, technical, and other resources, such as larger research and development staff and experienced marketing and manufacturing organizations with established sales forces.

Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies.

Currently, we are not aware of other companies pursuing a business model similar to what we are developing under our microbial filamentous fungal-based protein production platform.

However, our competitors using other protein production platforms who are significantly larger and better capitalized than us, could potentially adopt strategies similar to our and even 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 operating in the human health and animal health fields.

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

Unlike in human and animal health, 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 non-pharmaceutical applications, such as food, nutrition, and wellness.

We believe that our microbial fungal based protein production platforms, including C1 and Dapibus™, have significant potential to become an alternative to several traditional production technologies currently used in the biopharmaceutical industry to produce vaccines, monoclonal antibodies, and other therapeutic proteins for both the human and animal health markets.

C1 has some inherent benefits and potential competitive advantages compared to CHO cells, E.

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

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.

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 process media.

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 the easiest, cheapest, and quickest method for recombinant protein expression and are often used in laboratory settings as well as commercial production of certain non-glycosylated proteins.

However, they produce toxic and pyrogenic cell wall components that may make them less suitable to produce biopharmaceuticals or food components.

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.

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.

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

Disadvantages include the typically lower protein titers than C1-cells and traditional yeast cells have a greater number of higher N and O glycosylation structures.

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:

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

Disadvantages include the comparably lower protein yields than C1 and the need for an added viral inactivation step.

We believe that our microbial protein production platforms hold the potential to become leading protein production platforms for developing and manufacturing proteins across various sectors, including biopharmaceuticals, food, nutrition, wellness, drug formulation, and research diagnostics, based on our platform's capability to expedite development processes, achieve high protein yields, scale efficiently, utilize low-cost media, and ultimately reduce production costs.

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.

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

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

and foreign governmental agencies, we continue to believe that the biopharmaceutical market is an attractive opportunity to apply our C1-cell protein production platform.

The Company continues to evaluate potential opportunities to expand the application of our C1-cell protein production platform, and is currently focused on the following 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.

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

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Drug formulation, research diagnostic and reagents

Alternative proteins for food, health and wellness

The use of biologic medicines, for applications such as infectious disease vaccines and therapeutics are growing significantly.

However, biologic medicines are in many cases limited and expensive for both patients and health care systems.

The Company believes that lack of access and high cost is, in part, the result of the following bottlenecks in the development and manufacture of biologic medicines:

Extended stable cell line development timelines

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

Expensive, often royalty stacked, production media in the case of CHO cell lines

Long production time for stable CHO cell lines

Previously underfunded development efforts for more efficient next-generation gene expression systems

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

Such a platform could facilitate the rapid and high titer production of difficult to express proteins resulting in greater patient access and more affordable biopharmaceuticals.

We believe that our C1-cell protein production platform has the potential to be an alternative to CHO, Baculovirus and other traditional expression systems to produce proteins for vaccines, therapeutics, diagnostics, alternative foods, nutrition and wellness and other biological products.

Our Research Partners and Contract Research Organizations (CROs)

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

Research and Development Agreement with VTT Technical Research Centre of Finland, Ltd ( “ VTT ” )

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 the Company’s C1-cell protein production platform to ensure a safe and efficient expression system for use in speeding up the development and lowering the cost of manufacturing pharmaceutical products and processes.

(“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 our C1-cell protein production platform.

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

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.

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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 CR2O, a contract research organization, to manage and support further preclinical and clinical development of DYAI-100, 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 for other reasons could lead to delays or inability to realize our research and commercial objectives.

The Company, supplemented by third party funding is also further developing its Dapibus™ protein production platform for use in non-pharmaceutical applications, such as food, nutrition, and wellness.

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

C1 Production Host Improvement Programs

The Company has research and development agreements with VTT, Eleszto Genetika (Budapest, Hungary), other CROs and service and technical providers to further improve its C1-cell protein production platform to become an even more robust, versatile, and efficient therapeutic protein production platform.

Ongoing projects include, among others:

(i) improving the C1 genetic tools, (ii) further reducing the background protease(s) levels by identifying and deleting certain protease genes and/or modifying C1 fermentation processes, (iii) developing high expression C1 cell lines by precision engineering, (iv) developing C1 cell lines to express several potential vaccine and drug candidates and (v) modifying the glycosylation pathway of C1 cells in order for C1 to express certain mAbs and other proteins with mammalian like glycosylation structures and to eliminate or modify certain unwanted glycan structures such as N and O-glycosylation.

We continue to generate a growing amount of data that demonstrates different C1-produced proteins are properly folded and are biologically active:

Further development of DYAI-100 (SARS-CoV-2 RBD) vaccine candidate by preparing C1 cell lines that express and produce effective antigens against different variants of the SARS-CoV-2 RBD in order to implement the FDA recommendation to produce annual multivalent vaccines against SARS-CoV-2 that are suitable for the annual global threat.

Developing additional antigens that were produced by C1 (e.g., SARS-CoV-2 Full Spike Protein, hemagglutinin (HA) and Neuraminidase (NA)) which were not only produced at high levels, but they were also importantly shown to be safe, effective, and protective in several animal trials and in the case of influenza a challenge test carried out by Oslo University demonstrated the potential of C1 produced antigens for seasonal and pandemic influenza.

Developing C1-cells to express complex proteins such as conjugating antigens to ferritin nanoparticles, scFv (MHCII) and trimerization domains to increase efficacy.

Developing the C1-cell protein production platform for expressing mAbs at relatively high levels and high quality (e.g., data from more than one large pharma collaborator demonstrated that the binding kinetics of mAbs produced from C1 are virtually indistinguishable from the binding kinetics of reference mAbs which were produced in CHO cells).

Success in glycoengineering C1 cells to express mAbs that have human-like glycan structures.

Expressed a number of third-party monoclonal antibodies (mAbs) which were assayed by multiple third parties who reported that the neutralizing and binding activity assays demonstrated great similarity between C1-produced mAb and CHO-produced mAbs.

Expressed a number of other types of therapeutic proteins, such as bi-specifics, tri-specifics and Fc-fusion proteins, at relative high yields compared to other production hosts and high quality (e.g., expressed a third party bi-specific antibody which was assayed by the third party in an in vitro cellular activity assay which indicated that dose response curves for the C1 expressed bi-specific antibody were very similar to the CHO expressed bi-specific antibody).

Developed the C1-cell protein production platform to express human and bovine serum albumin and other recombinant proteins with therapeutic, drug formulation, and research diagnostic applications.

Glycosylated Therapeutic Programs and Potential Nivolumab Commercialization Program

The Company’s longer-term objective, which will require substantially more time and capital, is to apply the C1-cell protein production platform for the large therapeutic glycoprotein market.

We believe that the rapid advances being made in genomics and synthetic biology, make the C1 fungal cell line a promising candidate to further engineer glycosylation pathways:

(i) to produce therapeutic proteins having human-like glycoforms structures such as G0, G2, G0F, and G2F; (ii) to reduce or eliminate O-glycosylation; and (iii) to create potentially improved immunogenicity in the case of vaccines.

The initial steps to develop C1 strains that produce mAbs with mammalian-like glycosylation are progressing at VTT.

Based on research results we have to date, the Company believes that our C1-cell protein production platform has the potential to become a useful platform for the development and production of therapeutic glycoproteins with human-like or potentially even superior glycan structures.

We believe that, if successful, the glycoengineering of C1 cells may help to position the C1 protein production platform to be an important production platform for developing and manufacturing glycosylated antibodies and other glycoproteins.

These initial glycoengineered C1 cells have to date shown reduced gene expression levels when compared to the non-glycoengineered C1 cells.

Several approaches are now being applied to reach our main goal – to develop cell line(s) that resemble the 3 main goals:

(i) to produce therapeutic proteins having human-like glycoform structures, (ii) to produce therapeutic proteins at high level and (iii) to produce stable therapeutic proteins.

We continue the development of Nivolumab (Opdivo®) as a potential biosimilar/biobetter immunotherapeutic biologic drug for human metastatic cancers, including melanoma, lung, and other cancers.

The aim of this program is to express Nivolumab (mAb) with a glycoprotein structure like Nivolumab produced in CHO cells.

So far, C1 produced Nivolumab has been produced with similar glycosylated structures and the development of high producing C1 cell line that expresses a lower cost biosimilar/Biobetter Nivolumab as part of its glycoengineering program for glycoprotein Immunoglobulin G (IgG) monoclonal antibodies is ongoing.

This project has proved the concept that C1-cell protein production platform can be applied to several very high value therapeutic or preventative monoclonal antibodies.

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

DYAI-100, a C1-SARS-CoV-2 recombinant protein RBD vaccine candidate, is the first C1-expressed protein tested in humans.

The Phase 1 randomized, double-blind, placebo-controlled trial was designed as a first-in-human trial to assess the clinical safety and antibody response of DYAI-100, produced using the C1 platform and administered as a booster vaccine at two single dose levels in healthy volunteers.

Following the regulatory clearance from the South African Health Products Regulatory Authority (SAHPRA), the trial was initiated in 1Q 2023 with the last patient visit occurring in 3Q 2023.

On November 29, 2023, the Company announced the top-line safety results, indicating that the study had met its primary endpoint that both the low and high dose levels of the vaccine are safe and well tolerated among participants.

Additionally, the vaccine has been shown to induce immune responses at both dose levels, suggesting its potential efficacy in generating protective immunity against the target virus.

On March 25, 2024, the Company entered into a funded research collaboration with a top ten pharmaceutical company to develop a vaccine antigen and a monoclonal antibody produced from the C1 technology.

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

In March 2024, a manuscript of preclinical studies on C1 produced monoclonal antibody in non-human primates and hamsters was published in the prestigious peer-reviewed journal Nature Communications.

A non-human primate challenge study completed dosing of a C1 produced COVID-19 monoclonal antibody that had previously demonstrated broad neutralization and protection against Omicron (BA.1 and BA.2) and the other earlier variants of concern in hamsters.

Preliminary results obtained from the challenge study with the SARS-CoV-2 Delta virus on non-human primates demonstrated potential high protection.

This was the first time a C1-produced monoclonal antibody was used in a non-human primate study validating the safety and efficacy of a C1 produced antibody for infectious diseases.

At the NIIMBL conference in February 2024, the Company showcased our project data and research results generated from the NIIMBL Grant received by the Company under the previously announced White House’s American Rescue Plan.

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 Dyadic’s C1 protein production platform 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.

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.

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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 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 protein expression platforms.

On February 6, 2024, the Company announced it has signed a fully funded evaluation agreement including a commercial option with an undisclosed leading global biopharmaceutical company to design and produce recombinant proteins using Dyadic’s C1 filamentous fungal-based microbial protein production platform.

On October 25, 2023, the Company announced that it has entered into a new research collaboration with the Vaccine and Immunotherapy Center (“VIC”) at Massachusetts General Hospital to express vaccine antigens for influenza A and other infectious diseases, as part of VIC's $5.88 million award from the Department of Defense (“DoD”).

On September 26, 2023, the Company entered into a development and commercialization agreement with bYoRNA combining bYoRNA’s novel eukaryotic “bio” RNA platform with Dyadic’s industrially proven C1 protein production platform to provide the pharmaceutical industry with a potentially more cost-efficient platform for manufacturing large quantities of lower cost mRNA, enabling access to mRNA vaccines and drugs to a broader global population.

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

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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-cell protein production platform has been completed.

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.

Since then, the Company has expanded the Phibro/Abic Agreement to include additional research projects to develop vaccines and treatments for companion and livestock animal diseases.

Non-pharmaceutical Programs

Dyadic’s newly developed Dapibus™ filamentous fungal based microbial protein production platform is reengineered 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.

Given Dyadic’s industrial heritage, the expertise to rapidly achieve commercial scale within margin sensitive markets such as food and nutrition enzymes, provides our partners with the ability to move from demonstration to commercial production quickly and efficiently.

We are actively applying our proprietary Dapibus™ platform 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:

In March 2024, the Company executed a term sheet with a global albumin manufacturer and distributor to develop and license Dyadic’s recombinant serum albumin initially for diagnostic and research-grade purposes.

Animal-free recombinant serum albumin projects were initiated for use in potential non-pharmaceutical applications such as a component of cell culture media in nutrition, health, and food.

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

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

for the promotion of growth media supplement for cell culture.

The Company has commenced a development program to produce recombinant transferrin for use in cell culture media for the alternative protein industry, and initial production via our microbial platform was successful.

The Company is currently providing samples of recombinant bovine serum albumin for application testing as growth media for the cultured meat industry.

Non-animal Dairy Products

In September 2023, the Company entered into a development and exclusive license agreement to commercialize certain non-animal dairy enzymes used in the production of food products using Dapibus™ and received an upfront payment of $0.6 million in October 2023.

The Company believes it has achieved the specified target yield level required for a milestone payment.

The Company has developed a highly productive strain and is providing samples of recombinant alpha-lactalbumin, a whey protein, to interested collaborators.

The Company has initiated a beta-lactoglobulin animal-free recombinant whey protein project in early 2024.

The Company has commenced a recombinant lactoferrin development program and expects to provide samples of the product in the third quarter of 2024.

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

Bio Industrial Products

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

On March 8, 2024, the Company issued an aggregate principal amount of $6.0 million of its 8.0% Senior Secured Convertible Promissory Notes due March 8, 2027 (the “Convertible Notes”) in a private placement in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended.

The purchasers of the Convertible Notes include immediate family members and family trusts related to Mark Emalfarb, our President and Chief Executive Officer and a member of our Board of Directors, including The Francisco Trust, an existing holder of more than 5% of the Company’s outstanding common stock.

For the year ended December 31, 2023, the Company received approximately $1.3 million from the sale of its equity interest in Alphazyme LLC (“Alphazyme”).

Dyadic previously received its equity as part of the consideration for the grant of a non-exclusive license to certain of Dyadic's technology.

Dyadic has the right to receive milestone and royalty payments based on potential sales of C1-expressed products by Alphazyme.

Dyadic also has the potential to receive additional payments based on future sales of Alphazyme's existing products.

In April 2023, the Company received a Notice of Allowance from the U.S.

Patent and Trademark Office (USPTO) for patent application 16/640,483, titled “PRODUCTION OF FLU VACCINE IN MYCELIOPHTHORA THERMOPHILA” (the “Patent”), and is expected to provide patent protection through 2038.

The Patent will cover claims for the development and manufacture of seasonal and pandemic influenza vaccines from the Company’s C1 protein production platform.

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 biotechnology company that operates in the United States, we are subject to extensive regulation.

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.

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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 “Risk Factors—Risks Related to Government Regulations and Environmental, Social, and Governance Issues.”

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.

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The duration of foreign patents varies similarly, in accordance with local law.

Currently, Dyadic owns or has exclusive rights to seven (7) patent families, of which five (5) entered the national phase.

The other two (2) applications are at the international (Patent Cooperation Treaty, PCT) phase.

There are currently one (1) patent and five (5) pending patent applications in the United States, one patent in South Africa, and eighteen (18) additional patent applications in a variety of jurisdictions including Europe and China.

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.

Our patent position and proprietary rights are subject to various risks and uncertainties.

Please read the “Risk Factors” in Item 1A of this Annual Report for information about certain risks and uncertainties that may affect our patent position and proprietary rights.

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.

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What changed 10-K

Item 1. Business