Item 1. Business
Item 1.
Business
Overview
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.
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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:
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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.
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Bacterial: 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.
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Yeast: 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.
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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.
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Trichoderma: 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.
Competition
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.
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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.
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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.
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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
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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.:
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Reagents & Biotech – Affordable recombinant enzymes and proteins enhance molecular biology workflows, diagnostics, and biopharmaceutical research.
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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.
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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.
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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:
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Recombinant vaccines and drugs for animal and human health
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New innovative biotherapeutics
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Biosimilars / Biobetters non-Glycosylated/Glycosylated protein markets
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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:
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Extended timelines for stable cell line development and manufacturing
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Insufficient titers and overall yields
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High production costs, due to expensive media and other consumables
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Long production cycles for stable mammalian and insect (i.e., baculovirus) cell lines
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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.
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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:
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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.
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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
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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:
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Continued development and refinement of Dapibus™ to enhance overall robustness, versatility, and efficiency.
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Generation of Dapibus™ production strains specifically engineered for applications in dairy processing, biofuels, biogas, biorefining enzymes, and alternative protein production.
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Ongoing improvement of genetic engineering tools to accelerate strain development and optimize expression profiles.
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Identification and targeted deletion of background protease genes to further reduce proteolytic activity, thereby improving yield and product quality.
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Modification and refinement of both fermentation protocols and downstream purification processes to increase production efficiency and reduce cost of goods.
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Development of high expression Dapibus™ cell lines through precision engineering techniques to meet the growing demand for cost‐effective protein production.
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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.
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Recent advancements demonstrate the platform’s capability to produce properly folded, biologically active proteins:
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Expansion of the platform for human and bovine serum albumin and other recombinant proteins for therapeutic, drug formulation, research, and diagnostic applications.
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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.
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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.
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Expression of complex proteins, including conjugated antigens, scFv (MHCII), and trimerization domains to enhance efficacy.
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Successful monoclonal antibody (mAb) production, with C1produced mAbs showing binding kinetics virtually identical to CHO-produced mAbs.
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Glycoengineering of C1 cells to produce mAbs with human-like glycan structures and third-party validation of C1-produced mAbs' neutralizing and binding activity.
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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.
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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
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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.
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In March 2024, the Company entered into a co-promotion agreement with Biftek Co. for the promotion of growth media supplement for cell culture.
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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.
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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.
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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
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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™.
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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.
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In 2024, the Company initiated development of recombinant human alpha-lactalbumin for use in the pharmaceutical, nutraceutical, medical nutrition, and infant formula markets.
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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.
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The Company has produced four casein proteins and is in active discussions with potential collaborators.
Reagent Proteins & DNA/RNA Enzymes
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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.
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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
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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.
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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.
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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.
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Pharmaceutical Programs
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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.
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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
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H5 Avian Influenza (“Bird Flu”) Vaccine Candidate (in collaboration with ViroVax, LLC):
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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.
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Pre-commercial research and validation efforts are actively underway to support potential strategic partnerships and licensing opportunities.
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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
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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.
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Poultry & Cattle Applications:
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Poultry: 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.
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Cattle: 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. For additional discussion on the effect of existing or probable governmental regulations on our business, see “Item 1A. Risk Factors—Risks Related to Government Regulations and Environmental, Social, and Governance Issues.”
Employees
As of December 31, 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. U.S. patents, as well as most foreign patents, are generally effective for 20 years from the date the earliest patent application was filed. In some cases, the patent term may be extended to recapture a portion of the term lost during the U.S. FDA regulatory review or because of U.S. Patent and Trademark Office (“USPTO”) delays in prosecuting the application. The duration of foreign patents varies similarly, in accordance with local law.
Currently, Dyadic owns or has exclusive rights to 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 “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.
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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.