SAB Biotherapeutics (NasdaqCM:SABS) 2026 Conference Transcript

Summary of SAB Biotherapeutics Conference Call Company Overview - Company: SAB Biotherapeutics (NasdaqCM:SABS) - Focus: Development of new medicines for type 1 diabetes, aiming to change the course of the disease rather than just treat symptoms [2][3] Industry Context - Market Opportunity: Type 1 diabetes represents a major unmet medical need with no approved drugs currently available, creating a multi-billion dollar market opportunity [3][6] - Patient Demographics: Approximately 64,000 new patients are diagnosed with type 1 diabetes each year [6] Key Product Information - Lead Asset: SAB-142, an anti-thymocyte immunoglobulin that is fully human [2][15] - Mechanism of Action: SAB-142 induces T cell exhaustion while preserving regulatory T cells (Tregs), which is critical for self-tolerance [11][15] - Clinical Trials: Currently in a pivotal phase 2b trial named SAFEGUARD, targeting newly diagnosed patients within 100 days of diagnosis [28][43] Clinical Trial Details - Phase 1 Study: Completed in 2024, demonstrated safety and absence of serum sickness or anti-drug antibodies [17][22] - Dosing for SAFEGUARD: Two doses being tested: 2.5 mg/kg and 1.5 mg/kg [19][20] - Primary Endpoint: C-peptide preservation at one year, with a target of 40% preservation considered clinically meaningful [44][47] - Enrollment Timeline: Expected to complete enrollment by the end of 2026, with data anticipated in the second half of 2027 [43] Competitive Landscape - Competitors: Tzield, which is under review for approval in stage 3 type 1 diabetes, has shown regulatory clarity and a potential path for approval based on C-peptide preservation [53] Commercial Strategy - Market Preparation: Early commercial activities are underway, including the hiring of David Zaccardelli as chairman, who has experience in successful drug launches [49] - Addressable Market: Focus on newly diagnosed patients and potential expansion to stage 2 patients, which could significantly increase the market size [50][51] Financial Health - Cash Position: SAB Biotherapeutics had approximately $140 million in cash at the end of 2025, sufficient to fund operations through 2028 [54] Additional Insights - Regulatory Strategy: Engaging with regulatory agencies to ensure a clear path for approval and to establish a favorable safety profile before moving to younger patient populations [29][30] - Long-term Vision: The company aims to develop therapies that can preserve beta cell function in earlier stages of type 1 diabetes, potentially leading to a functional cure [50][51]