Summary of Dyadic International Conference Call Company Overview - **Company**: Dyadic International (Ticker: DYAI) - **Industry**: Biotechnology, specifically focusing on recombinant proteins and enzymes for life sciences, food, nutrition, and bioindustrial applications - **Key Personnel**: Joe Hazelton, President and COO, with prior experience at Novartis Pharmaceuticals [2][3] Core Points and Arguments - **Strategic Shift**: Dyadic has transitioned from a platform-based organization to a product-focused company, emphasizing high-growth non-therapeutic markets to generate revenue more quickly and reliably [2][3][4] - **Technology Platforms**: The company utilizes two main platforms: - **C1 Adaptabus**: Focused on producing high-yield, animal-free recombinant proteins for life sciences and biopharmaceuticals [3][4] - **Dapivis**: Designed for food, nutrition, and bioindustrial markets, offering lower-cost production of proteins and enzymes [8][9] - **Market Opportunities**: Dyadic targets a total addressable market of approximately $25 billion across various sectors, including life sciences, food, nutrition, and bioindustrial applications [4][32] - **Revenue Generation**: The company is moving towards commercialization with initial revenue streams from partnerships and product launches expected in 2025 and beyond [11][12][35] Financial Projections - **Cash Flow Positive**: Dyadic anticipates becoming cash flow positive by the end of 2026, with a low annual burn rate of $4 million to $5 million [34][35] - **Revenue Ramp**: The company expects significant revenue growth driven by partnerships, particularly in the cell culture media market, which is projected to be a billion-dollar opportunity [36][37] Market Segments and Products - **Life Sciences**: Targeting a $10 billion market, focusing on cell culture media, diagnostics, and therapeutic proteins [8][12] - **Key Products**: Recombinant human albumin, transferrin, and growth factors, which are critical for biomanufacturing [14][15] - **Food and Nutrition**: Estimated at $11 billion, focusing on non-animal dairy and functional proteins [17][18] - **Partnerships**: Collaborations with companies like Enzymes for non-animal dairy enzymes, with expected product launches in late 2025 [17][28] - **Bioindustrial**: Aiming for a $100 billion market, focusing on enzymes for biomass conversion and other industrial applications [10][20] Competitive Advantages - **High Yield and Low Cost**: Dyadic's platforms are designed to produce high-quality, sustainable, and ethically sourced proteins at competitive costs, addressing the market shift towards non-animal solutions [6][32] - **Faster Time to Market**: The company emphasizes shorter development cycles compared to traditional biopharmaceuticals, allowing for quicker revenue generation [11][24] Partnerships and Collaborations - **Strategic Partnerships**: Dyadic has established partnerships with key players in the industry, such as Proliant Health and Biologicals, to leverage their distribution networks and expertise [13][36] - **Funding and Grants**: The company has secured funding from organizations like the Gates Foundation and is involved in initiatives like the European Vaccine Hub, which supports its biopharmaceutical programs [30][31] Conclusion - **Inflection Point**: Dyadic is at a critical juncture, transitioning from R&D reliance to active commercialization of products, with a strong focus on non-therapeutic markets that promise quicker revenue streams [33][34] - **Future Outlook**: The company is optimistic about its growth trajectory, with expectations of profitability within three years as it capitalizes on its innovative platforms and market opportunities [35][37]

Core Viewpoint - Dyadic International, Inc. is transitioning from a technology development organization to a market-facing, revenue-focused biotechnology company, with significant advancements in its life sciences and nutrition pipelines, and a recent capital raise to support this shift [2][4]. Company Developments and Updates - The company completed a strategic leadership and operational transformation, rebranding as Dyadic Applied BioSolutions to emphasize commercial execution [4]. - Dyadic raised $5.3 million through an equity offering to enhance liquidity and fund pipeline and commercial growth [4][11]. - As of June 30, 2025, the company reported cash and equivalents of $7.3 million, down from $9.3 million at the end of 2024 [10]. Financial Highlights - Total revenue for Q2 2025 reached $967,000, a significant increase from $386,000 in the same period last year, driven by milestone revenues [12][13]. - Research and development expenses rose to $629,000 from $516,000 year-over-year, reflecting increased internal research initiatives [14]. - General and administrative expenses decreased by 10.6% to $1,437,000 compared to $1,608,000 in the previous year [15]. - The net loss for Q2 2025 was $1,794,000, an improvement from a net loss of $2,045,000 in the same quarter of the previous year [17]. Product Development and Partnerships - Dyadic is advancing its recombinant serum albumin and transferrin products, with expected commercial launches in 2025 [5]. - The company is also developing additional nucleic acid enzymes to meet growing demand for DNA/RNA manipulation tools, with results anticipated by late 2025 [6]. - Dyadic has achieved milestones in its partnership with the Gates Foundation, receiving $1.5 million in funding for monoclonal antibody development [12]. Market Focus - Dyadic's microbial production platforms are positioned to disrupt the cost, speed, and scalability of protein production across various markets, particularly as industries shift towards non-animal sources [2][4]. - The company is actively negotiating licensing and supply agreements for its recombinant alpha-lactalbumin and expects to launch additional non-animal dairy enzymes by late 2025 [12].

Company Overview - Dyadic is a bioprocessing platform company transitioning from R&D to commercial revenue generation[4, 10, 24] - The company has two validated platforms, C1 and Dapibus, targeting life sciences, food/nutrition, and bio-industrial markets[4, 24] - Dyadic's market capitalization is $3009 million as of July 21, 2025, with approximately $74 million in cash and investment-grade securities as of March 31, 2025[62] Market Opportunity - The company is targeting a $25 billion+ market opportunity across key segments[7, 62] - The recombinant food & nutrition market is estimated at ~$11 billion in 2025[16, 31] - The cell culture media market is estimated at ~$5 billion in 2025, while the molecular biology reagents market is estimated at ~$2 billion in 2025[25, 27] - The recombinant bio-industrial enzymes market is estimated at ~$6 billion in 2025[16, 36] Commercial Strategy - Dyadic is focused on non-therapeutic applications for near-term revenue generation[4, 20, 62] - The company utilizes three revenue pathways: strain licensing, strategic partnerships, and direct product sales[42] - Initial revenue streams are active, with multiple non-therapeutic protein products expected to launch over the next 12-36 months[7, 24]

DNase I Oncology Platform - The company is focused on advancing its proprietary DNase I technology platform to address multiple high-value cancer indications[2, 5] - DNase I targets Neutrophil Extracellular Traps (NETs) to improve immunotherapies and chemotherapies[2, 5] - DNase I digests both double and single-stranded DNA, as well as DNA:RNA hybrids, exposing cancer cells to the immune system and reducing therapy resistance[6] - Systemic administration of DNase I improves the efficacy of PD-1 blockade, resulting in the lowest tumor volume growth compared to either DNase I or anti-PD-1 alone[19] Pipeline and Clinical Development - The company's lead program, XBIO-015, combines systemic DNase I with chemotherapy for pancreatic carcinoma[7] - A Phase 1 study is planned, featuring dose escalation and expansion in subjects with locally advanced or metastatic solid tumors, with pancreatic cancer and other solid tumor indications[2, 40] - The company believes that an ORR greater than 50% or PFS greater than 9 months would be a meaningful improvement to the current standard of care for pancreatic cancer[45] Market Opportunity - The company is initially targeting pancreatic carcinoma, a multi-billion-dollar indication with significant unmet need, with a projected market of $48 billion by 2025[2, 39] - Approximately 62,000 people are diagnosed with pancreatic cancer annually, and approximately 50,000 die from it annually[39] - There were approximately 19 million new solid tumor cases in the U S in 2022, leading to approximately 6 million solid tumor-related deaths[46] Collaboration and Intellectual Property - The company is collaborating with VolitionRX to develop proprietary adoptive cell therapies potentially targeting multiple solid cancer types[2, 58] - VolitionRX is expected to fund the research program, with both parties sharing proceeds from commercialization or licensing of any resulting products[60] - The company has an IP portfolio covering the co-administration of Systemic DNase I with ICIs, radiation, and chemo, as well as DNase I for pancreatic cancer and DNase I-secreting CAR T cells[62, 64]