Core Insights - Dyadic Applied BioSolutions has announced a significant expansion of its collaboration with Fermbox Bio, enhancing their joint capabilities in producing animal-free proteins and enzymes for various applications [1][2][3] Group 1: Collaboration Expansion - The expanded partnership allows Fermbox Bio to manufacture and commercialize a broader portfolio of Dyadic-developed proteins and enzymes using the Dapibus™ and C1 expression systems [1][2] - This collaboration will enable both companies to incorporate products developed on Fermbox Bio's proprietary microbial platforms into their joint portfolio, enhancing the diversity and competitiveness of their offerings [2][6] Group 2: Market Impact - The agreement is expected to accelerate product development, shorten commercialization timelines, and strengthen the companies' reach into high-growth markets, particularly in recombinant proteins for life sciences and food and nutrition [2][4] - The demand for sustainable, economically viable animal-free ingredients continues to increase, positioning the companies favorably in the market [2] Group 3: Leadership Comments - Joe Hazelton, President & COO of Dyadic, emphasized that the collaboration enhances Dyadic's go-to-market capabilities by combining high-productivity microbial platforms with Fermbox's manufacturing infrastructure [3] - Subramani "Subbu" Ramachchandrappa, CEO of Fermbox Bio, highlighted the commitment to collaboratively leverage complementary capabilities to develop and scale a broad pipeline of precision fermentation-derived bioproducts [4]

Core Insights - Dyadic Applied BioSolutions has entered into a commercial agreement with Opes Diagnostics Limited to support the launch of its recombinant proteins for serum-free cell culture media applications in various markets [1][2][4] Company Overview - Dyadic is a global biotechnology company that produces precision-engineered, animal-free proteins and enzymes for life science, food & nutrition, and bioindustrial markets [1][5] - The company utilizes proprietary microbial expression platforms to manufacture recombinant proteins, which are designed to enable customers to develop more efficient and sustainable products [5] Partnership Details - Under the agreement, Opes will leverage its existing relationships to identify potential customers primarily in Europe, Israel, and Asia, facilitating market entry for Dyadic's recombinant protein portfolio [2][3] - The collaboration aims to enhance the penetration of Dyadic's products in industries such as research, diagnostics, cultured meat, and biomanufacturing [3][4] Market Strategy - The partnership is expected to drive the adoption of Dyadic's cell culture media products into expanding markets, transitioning the company from development activities to broader commercial engagement [4]

Core Viewpoint - Dyadic International is positioned at a commercial inflection point with multiple products entering the market and active revenue streams, focusing on scalable, animal-free recombinant protein solutions for various sectors [2]. Company Overview - Dyadic International was founded in 1979 and has a history of innovation in industrial biomanufacturing, particularly in the industrial enzymes business, which was acquired by DuPont for $75 million in 2015 [4]. - The company has transitioned its focus towards producing high-value input proteins in sustainable and predictable areas, moving away from traditional animal-derived proteins [4][5].

Summary of Dyadic International Conference Call - December 09, 2025 Company Overview - **Company**: Dyadic International (NasdaqCM:DYAI) - **Industry**: Biomanufacturing, Life Sciences, Food Nutrition, Bio-Industrial Markets - **Focus**: Scalable, animal-free recombinant protein solutions Key Points and Arguments 1. **Commercial Inflection Point**: Dyadic is at a significant commercial inflection point with multiple products entering the market and active revenue engines [2][4][30] 2. **Transition from R&D to Commercialization**: The company has shifted focus from R&D and grant-based revenues to commercial applications, particularly in non-therapeutic areas that do not require FDA review [3][5][30] 3. **Product Launch Timeline**: Dyadic expects multiple product launches starting in 2025 and continuing through 2027, with a focus on life sciences, food nutrition, and bio-industrial segments [4][10][32] 4. **Platform Technologies**: The company utilizes two main platforms, C1 and Dapibus, designed for speed, productivity, scale, and low cost, to produce recombinant animal-free protein solutions [7][9][30] 5. **Market Segments**: - **Life Sciences**: Focus on cell culture media, cell and gene therapy, and high-value proteins like human transferrin and albumin [11][15][19] - **Food Nutrition**: Targeting the alternative protein market, particularly non-animal dairy and functional food proteins, with a market size estimated at $50-$70 billion [12][22] - **Bio-Industrial**: Re-entering the market through partnerships, focusing on cellulosic enzymes with a market size of approximately $6 billion [13][14][23] 6. **Revenue Generation Strategy**: Dyadic employs a three-pillar strategy: buy, brand, and build, allowing for direct sales, licensing, and partnerships to monetize its technology [9][10][19] 7. **Partnerships**: Collaborations with companies like Proliant Health and Fermbox Bio are expected to drive revenue growth and product launches [16][23][29] 8. **Regulatory Advantages**: The focus on non-therapeutic products allows for faster market entry, with timelines of 12-18 months from proof of concept to revenue [5][18][31] 9. **Financial Projections**: The company anticipates meaningful revenue growth starting in early 2026, with a revenue run rate of approximately $12 million needed to reach cash flow positive status [33][37] Additional Important Information - **Innovation and Technology**: Dyadic has access to CRISPR technology, enhancing its ability to optimize production strains [4][30] - **Market Trends**: The shift towards sustainable and predictable proteins is driving demand for Dyadic's products, particularly in the context of growing consumer preference for non-animal sources [3][12] - **Future Outlook**: The company is positioned for significant growth with a layered revenue approach, leveraging existing partnerships and expanding its product portfolio [26][27][32] This summary encapsulates the key insights from the Dyadic International conference call, highlighting the company's strategic direction, market opportunities, and financial outlook.

Core Insights - Dyadic Applied BioSolutions and BRIG BIO have signed a Development and Commercialization Agreement to jointly develop and commercialize recombinant bovine alpha-lactalbumin [1][2] Partnership Overview - The partnership aims to leverage Dyadic's innovation capabilities and BRIG BIO's expertise in dairy and medical nutrition to produce scalable, cost-effective animal-free alpha-lactalbumin for various nutrition markets [2][6] - BRIG BIO will fully fund the development program and obtain a global commercial license for Dyadic's production strains, while Dyadic will receive milestone payments and revenue participation from commercial sales [3] Market Potential - The global market for alpha-lactalbumin is projected to grow from approximately USD 760 million in 2025 to over USD 1.6 billion by 2035, driven by demand in infant formula and medical nutrition [4][5] - The shift towards high-purity, functional proteins and the advantages of precision-fermented alpha-lactalbumin over traditional dairy sources are expected to support long-term adoption by global nutrition brands [5] Leadership Commentary - Dyadic's President & COO highlighted that the agreement positions the company to benefit from milestone and royalty revenue, as well as co-marketing rights, emphasizing the alignment of both companies' strengths [7] - BRIG BIO's CEO noted that the collaboration will enhance their ability to deliver high-quality, precision-fermented dairy proteins, addressing global food uncertainty [8] Company Profiles - Dyadic Applied BioSolutions specializes in producing recombinant proteins for life sciences, food and nutrition, and bio-industrial markets, utilizing its proprietary microbial platforms [9] - BRIG BIO focuses on developing scalable, functional recombinant dairy proteins, emphasizing precision fermentation to secure high-performance nutritional products [10]

Financial Data and Key Metrics Changes - Total revenues for Q3 2025 decreased to $1,165,000 from $1,958,000 in the same period a year ago, primarily due to declines in research and development revenue and license and milestone revenue [23][24] - Research and development expenses increased to $572,000 from $460,000 year-over-year, driven by a rise in active internal research initiatives [24] - Net loss for Q3 2025 increased to $1,976,000 or $0.06 per share compared to a loss of $203,000 or $0.01 per share in the same period last year [25] Business Line Data and Key Metrics Changes - The Life Sciences segment is now operating as a product company, manufacturing and supplying lab-grade materials for multiple recombinant proteins [5][6] - The recombinant human albumin program is advancing towards a commercial launch in early 2026, with significant milestone payments received from ProLiant [6][7] - The first bulk purchase order for a Dyadic produced protein was achieved in October, validating the market readiness of the technology [8] Market Data and Key Metrics Changes - The cell culture media market is identified as a dynamic growth area, requiring consistent animal-free proteins for scalability and regulatory confidence [6] - The market for DNase one is approximately $250 million for recombinant products, with a broader market of $1.5 billion for all production methods [32] - The animal-free dairy protein market is expected to exceed $20 billion by 2035, driven by demand for sustainable protein production [13] Company Strategy and Development Direction - The company is transitioning from a platform-centric R&D organization to a commercially focused biotechnology company with a growing portfolio of high-value products [4][5] - Dyadic has rebranded as Dyadic Applied Biosolutions and is enhancing its technology foundation with CRISPR Cas9 gene editing capabilities [4][5] - The strategy includes expanding customer engagement in key global markets, particularly in Asia, Europe, and North America [76] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's transformation and execution, highlighting the first commercial bulk sale as a pivotal moment [4][5] - The focus remains on accelerating product sales across life sciences and molecular biology reagent portfolios, with early commercial traction already underway [76] - The company anticipates growth in product revenue in life sciences and food and nutrition markets while maintaining operating expenses in line with the previous year [26] Other Important Information - The company received a total of $1,500,000 in milestone payments from ProLiant, with expectations to share in profits as albumin products enter the market [7] - Dyadic's collaboration with Intralink aims to accelerate market penetration in Japan and South Korea, leveraging local expertise for effective market reach [11][12] Q&A Session Summary Question: What does the new relationship with ERS Genomics bring to the portfolio? - The CRISPR license enhances the genetic toolbox, accelerating product development and improving optimization yields, providing a competitive advantage in various markets [29][30] Question: How should the DNase one opportunity be viewed for growth in 2026 and beyond? - The DNase one market is substantial, and the focus is on securing OEM agreements for bulk sales, with expectations for steady growth as higher margin segments are targeted [32][34] Question: What characteristics of customers are expected in the Asian markets for DNase one and transferrin? - The target customers include cell and gene therapy manufacturers and suppliers, focusing on bulk purchase orders rather than individual institutions [36][37] Question: Can you elaborate on the CRISPR ERS agreement structure? - The agreement involves improving fungal cell lines for efficiency and quality, with confidentiality around financial specifics, but it is not comparable to CRISPR applications in pharmaceuticals [45][46] Question: How is the infant nutrition product being marketed? - The goal is to mimic human breast milk and bovine milk, with a focus on regulatory hurdles and consumer acceptance, presenting a significant opportunity in the market [51][53]

Financial Performance - Total revenue for Q3 2025 decreased to $1,165,000, down from $1,958,000 in the same period last year, primarily due to a reduction in active collaborations and license revenue [15]. - Loss from operations for Q3 2025 increased to $1,925,000 compared to $203,000 for the same period last year [20]. - Net loss for Q3 2025 was $1,976,000 or $(0.06) per share, compared to a net loss of $203,000 or $(0.01) per share in the same period last year [20]. - Total revenue for Q3 2025 was $1,164,617, a decrease of 40.5% compared to $1,957,500 in Q3 2024 [27]. - Research and development revenue for Q3 2025 was $350,046, down 34.2% from $532,500 in Q3 2024 [27]. - Net loss for Q3 2025 was $1,976,012, compared to a net loss of $203,460 in Q3 2024 [27]. - Basic and diluted net loss per share for Q3 2025 was $0.06, compared to $0.01 in Q3 2024 [27]. - Total costs and expenses for Q3 2025 were $3,089,986, an increase of 43% from $2,160,114 in Q3 2024 [27]. Cash and Assets - Cash position as of September 30, 2025, was approximately $10.4 million, an increase from $9.3 million as of December 31, 2024 [13]. - Total current assets as of September 30, 2025, were $11,545,262, an increase from $9,827,668 as of December 31, 2024 [29]. - The company reported an increase in accounts receivable to $916,574 as of September 30, 2025, from $237,027 as of December 31, 2024 [29]. Liabilities and Equity - Total liabilities increased to $9,065,423 as of September 30, 2025, compared to $7,459,985 as of December 31, 2024 [29]. - Stockholders' equity as of September 30, 2025, was $2,607,334, up from $2,470,290 as of December 31, 2024 [29]. Research and Development - Research and development expenses for Q3 2025 increased to $572,000 from $460,000 in the same period last year, driven by more active internal initiatives [18]. - Grant revenue increased to $814,571 in Q3 2025, compared to no grant revenue in Q3 2024 [27]. Strategic Partnerships and Product Development - Dyadic secured a non-exclusive CRISPR/Cas9 license with ERS Genomics to enhance production capabilities and product performance [6]. - The company received a total of $1.5 million in milestone payments for the development of animal-free serum albumin, with ongoing revenue sharing anticipated from future sales [10]. - Dyadic advanced its international growth strategy by partnering with Intralink to expand in Japan and South Korea, targeting the biopharma market [6]. - Dyadic launched EN3ZYME™, an enzyme cocktail for converting agricultural residue into fermentable sugars, with initial deliveries completed under a partnership with Fermbox Bio [16]. General and Administrative Expenses - General and administrative expenses rose to $1,481,000 in Q3 2025, up from $1,298,000 in the same period last year, reflecting increased rebranding and business development costs [19].

Financial Performance - Total revenue for Q3 2025 was $1,164,617, a decrease of 40.5% compared to $1,957,500 in Q3 2024[15] - Research and development revenue for Q3 2025 was $350,046, down 34.2% from $532,500 in Q3 2024[15] - Grant revenue increased to $814,571 in Q3 2025, compared to $0 in Q3 2024[15] - Net loss for Q3 2025 was $1,976,012, compared to a net loss of $203,460 in Q3 2024, representing a significant increase in losses[15] - Basic and diluted net loss per common share for Q3 2025 was $0.06, compared to $0.01 in Q3 2024[15] - For the nine months ended September 30, 2025, Dyadic reported a net loss of $5,797,365, compared to a net loss of $4,258,279 for the same period in 2024, indicating an increase in losses of approximately 36.2%[19] - For the nine months ended September 30, 2025, total revenues were $2,524,819, a decrease of 5.7% compared to $2,678,013 for the same period in 2024[156] - The net loss for the nine months ended September 30, 2025, was $5,797,365, compared to a net loss of $4,258,279 for the same period in 2024, representing a 36.2% increase in losses[156] Assets and Liabilities - Total current assets rose to $11,545,262 as of September 30, 2025, up 17.5% from $9,827,668 as of December 31, 2024[14] - Total liabilities increased to $9,065,423 as of September 30, 2025, compared to $7,459,985 as of December 31, 2024, reflecting a 21.5% rise[14] - Total stockholders' equity as of September 30, 2025, was $2,607,334, an increase from $2,470,290 as of December 31, 2024[14] - The accumulated deficit increased to $91,883,845 as of September 30, 2025, from $86,086,480 as of December 31, 2024[14] - As of September 30, 2025, Dyadic's total cash, cash equivalents, and restricted cash amounted to $7,155,788, up from $5,921,614 at the end of the same period in 2024, representing a 20.9% increase[19] - As of September 30, 2025, the company held $10.4 million in cash, cash equivalents, and investment securities, an increase from $9.3 million as of December 31, 2024[155] Research and Development - The company expects to incur losses and negative cash flows as it continues to develop its Dapibus and C1 platforms, indicating ongoing investment in R&D[27] - Research and development costs for the three months ended September 30, 2025, totaled $571,872, an increase of 24.2% from $460,241 in the same period of 2024[76] - For the nine months ended September 30, 2025, research and development costs reached $1,696,230, up 13.2% from $1,498,593 in 2024[76] - Research and development expenses for outside contracted services increased to $1,357,727 for the nine months ended September 30, 2025, compared to $1,119,502 in 2024, reflecting a 21.3% rise[156] - Dyadic is conducting internal and collaborative R&D to advance its microbial platforms across both pharmaceutical and non-pharmaceutical applications[178] Grants and Collaborations - Dyadic received a grant of $3,092,136 from the Gates Foundation for the development of monoclonal antibodies, highlighting its focus on revenue-generating collaborations[34] - The Company received a grant of $3,092,136 from the Gates Foundation for monoclonal antibody development, with approximately $2.4 million received as of September 30, 2025[93][94] - A funding award of $4.5 million was received from CEPI to advance the C1 platform, with the Company set to receive up to $2.4 million as a subcontractor[98] - The Company recognized grant revenue of $287,209 and $462,754, respectively, related to the CEPI Grant for the three and nine months ended September 30, 2025[99] - Dyadic has received a total of approximately $2.4 million in funding from the Gates Foundation for developing low-cost monoclonal antibodies for malaria and RSV[188] Stock and Financing - The company issued 6,052,000 shares of common stock in Q2 2025, raising approximately $4,940,695 after offering costs[17] - The company completed an underwritten offering of 6,052,000 shares at a price of $0.95 per share, raising net proceeds of $4.9 million[37] - The Company issued senior secured convertible promissory notes with an aggregate principal amount of $6.0 million, with interest payable quarterly at a rate of 8% per annum[112][113] - As of September 30, 2025, the accrued interest on the Convertible Notes to related parties was $25,133 and to other third parties was $60,000[122] - The company granted 698,500 stock options during the nine months ended September 30, 2025, with an average exercise price of $1.71[135] Strategic Initiatives - Dyadic's strategic shift focuses on commercializing non-therapeutic proteins, aiming for faster revenue generation and broader market reach[25] - Dyadic expects to commercialize multiple Dapibus™-enabled products starting in 2025 through strategic partnerships and internal manufacturing initiatives[164] - Dyadic partnered with Intralink to expand its commercial efforts in Japan and South Korea, targeting high-value animal-free proteins[184] - Dyadic rebranded as Dyadic Applied BioSolutions and launched a redesigned corporate website to support commercial growth[184] Compliance and Taxation - The company has cured Nasdaq listing deficiencies and regained compliance with the minimum Market Value of Listed Securities and Minimum Bid Price requirements[189] - The Company is required to estimate income taxes in each jurisdiction it operates, considering current tax exposure and temporary differences in revenue and expense recognition[208] - Significant management judgment is necessary for determining the provision for income taxes and deferred tax assets[208] - The Company currently does not face U.S. federal, state, and local tax examinations for years prior to 2022[210] - There are no off-balance sheet arrangements reported by the Company[211]

Core Insights - Dyadic International, Inc. has successfully transitioned from a research and development-driven company to a commercially focused biotechnology solutions provider, enhancing its growth potential through strategic initiatives and partnerships [2][5]. Financial Highlights - Total revenue for Q3 2025 decreased to $1.165 million from $1.958 million in Q3 2024, attributed to a decline in research and development revenue and license and milestone revenue, partially offset by an increase in grant revenue [15]. - The company reported a net loss of $1.976 million or $(0.06) per share for Q3 2025, compared to a net loss of $203,000 or $(0.01) per share for the same period in the previous year [19]. - As of September 30, 2025, the company had cash and cash equivalents totaling approximately $10.4 million, an increase from $9.3 million as of December 31, 2024 [13]. Operational Highlights - Dyadic completed a strategic pivot to focus on commercial applications, rebranding as Dyadic Applied BioSolutions and launching a redesigned website to enhance commercial engagement [5][6]. - The company advanced multiple recombinant protein programs toward commercialization and received its first purchase order in the cell culture media and molecular biology reagent segments [5]. - Dyadic secured a non-exclusive CRISPR/Cas9 license with ERS Genomics, enhancing its genetic engineering capabilities for improved productivity and product quality [6]. Corporate Development - Dyadic is expanding its commercial efforts in Asia by partnering with Intralink to target the growing biopharma markets in Japan and South Korea [6]. - The company has achieved key milestones in developing low-cost monoclonal antibodies for malaria and RSV, receiving approximately $2.4 million in funding from a $3 million grant [11]. - Dyadic's animal-free transferrin and recombinant growth factors have shown promising results in cell proliferation testing, with initial purchase orders expected by the end of 2025 [12]. Research and Development - The company is actively developing animal-free serum albumin in collaboration with Proliant Health, expected to launch commercially in late 2025 or early 2026 [6]. - Dyadic's C1 platform has been validated for vaccine antigen production, demonstrating comparable efficacy to traditional methods [6].

Core Insights - ERS Genomics and Dyadic Applied BioSolutions have entered into a CRISPR/Cas9 license agreement, allowing Dyadic to utilize ERS' extensive patent portfolio to enhance its bioproduction capabilities [1][2][3] Company Overview - ERS Genomics holds a portfolio of over 100 patents worldwide related to CRISPR/Cas9 technology, covering applications across various cell types and synthetic biology [3][6] - Dyadic Applied BioSolutions specializes in producing precision-engineered, animal-free proteins and enzymes for the life sciences, food and nutrition, and bio-industrial markets [5] Agreement Details - The agreement enables Dyadic to integrate CRISPR-based gene editing into its production platforms, specifically the C1 and Dapibus systems, to improve strain performance and product quality [2][3] - Financial details of the agreement have not been disclosed [4] Strategic Implications - The collaboration is expected to accelerate Dyadic's internal product pipeline and enhance the development of customized production strains for partners [2] - ERS Genomics emphasizes the importance of responsible use of CRISPR technology, aiming to support a wide range of applications in life sciences and bio-industrial sectors [2][3]