SAB Biotherapeutics (NasdaqCM:SABS) FY Conference Transcript

Summary of SAB Biotherapeutics FY Conference Call Company Overview - Company: SAB Biotherapeutics (NasdaqCM:SABS) - Lead Program: SAB-142, a human anti-thymocyte globulin for newly diagnosed type one diabetes patients [3][4] Industry Context - Target Disease: Type one diabetes, which currently has no approved therapies [5] - Market Opportunity: - Stage two diabetes market estimated at $250 million peak sales - Stage three market includes 64,000 newly diagnosed patients annually, potentially exceeding $5 billion depending on pricing and market share [44][45] Core Product Insights - SAB-142: - Developed to address safety issues associated with thymoglobulin, a rabbit-derived anti-thymocyte globulin [4][6] - Phase two b trial (Safeguard study) is pivotal, aiming to demonstrate definitive efficacy [5][26] - Raised $175 million to fund the Safeguard study [47] Clinical Development - Phase One Study: - Demonstrated no serum sickness or anti-drug antibodies, indicating safety for chronic dosing [10][11] - Showed mechanism of action similar to thymoglobulin, inducing T cell exhaustion while preserving T regulatory cells [10][11] - Phase Two Safeguard Study: - Patients will be dosed every six months, with data expected by the end of 2027 [17][31][32] - Study powered to show 40% preservation of C-peptide at one year, with historical data suggesting thymoglobulin achieved 50% [30] Competitive Landscape - Primary Competitor: T Shield, which has received FDA recognition for its potential in treating type one diabetes [36][38] - Regulatory Clarity: FDA confirmed the Safeguard study as registrational, providing confidence in the path to approval [26] Future Directions - Expansion Plans: - Potential to treat stage two patients and explore other autoimmune conditions [39][41] - Emphasis on immunomodulation for patients undergoing cell therapy [41] Financial Position - Capitalization: - Recently raised $175 million, expected to fund operations through 2028 [47] Key Takeaways - SAB Biotherapeutics is positioned to address a significant unmet need in type one diabetes with its lead product, SAB-142, which offers a safer alternative to existing therapies. - The company is well-capitalized to advance its clinical trials and has a clear regulatory pathway, enhancing its potential for market entry and success.