Summary of SAB Biotherapeutics FY Conference Call Company Overview - **Company**: SAB Biotherapeutics (NasdaqCM:SABS) - **Industry**: Clinical-stage biotechnology - **Lead Asset**: Human anti-thymocyte immunoglobulin for treating newly diagnosed type 1 diabetes patients - **Current Phase**: Entering phase 2b clinical trial, considered pivotal with expectations of being a best-in-class product [2][4][12] Core Product Insights - **Comparison with Rabbit ATG**: - Rabbit anti-thymocyte globulin (ATG) is the global standard for organ transplant but has safety issues (serum sickness) and cannot be redosed due to immunogenicity [4][10] - SAB's product aims to preserve C-peptide and reduce HbA1c without the adverse effects associated with rabbit ATG [4][10] - **MELD Study Findings**: - Conducted in Europe, showed that a lower dose (0.5 mg/kg) of rabbit ATG was effective without lymphodepletion, decoupling efficacy from lymphodepletion [9][10] - Confirms that the mechanism of action for both rabbit ATG and SAB's product leads to C-peptide preservation and HbA1c reduction [10][11] Regulatory Landscape - **FDA Insights**: - The FDA is increasingly open to approving drugs based on C-peptide preservation alone, as demonstrated by the trajectory of Tzield, which was acquired by Sanofi [13][15] - The approval of Tzield indicates a clearer path for SAB's product, as it suggests that C-peptide is a sufficient endpoint for approval [15][16] Clinical Trial Design - **SAFEGUARD Study**: - The study will be stratified by age groups (adults, adolescents, children) to ensure a balanced representation [17][18] - C-peptide levels will be a primary endpoint, with a baseline requirement of 200 picomole per liter [32][34] - The study aims for an 80% power to show a difference in HbA1c [35] - **Future Trials**: - Plans for a confirmatory trial in Stage 2 patients, focusing on early intervention to preserve insulin production [36][39] Market Opportunity - **Unmet Medical Need**: - There is a significant demand for therapies in type 1 diabetes, with 65,000 new patients diagnosed annually and no approved drug currently available [43][44] - The ability to preserve beta cell mass could drastically improve patient outcomes and quality of life, addressing a major burden of disease management [42][44] - **Commercial Potential**: - The product is expected to fill a critical gap in treatment options for type 1 diabetes, which is currently managed through insulin and glucose monitoring without altering long-term outcomes [42][44] Additional Considerations - **Patient Impact**: - The emotional and social burden of managing type 1 diabetes is significant, and the introduction of a drug that preserves insulin production could alleviate some of these challenges [42][44] - **Community Engagement**: - Emphasis on understanding patient experiences and needs through direct engagement with the diabetes community [44]

Summary of SAB Biotherapeutics (SABS) Conference Call Company Overview - **Company**: SAB Biotherapeutics (SABS) - **Industry**: Biotechnology - **Focus**: Clinical stage biotech company specializing in human IgG products for autoimmunity, particularly type one diabetes (T1D) [4][5] Key Milestones and Developments - **Clinical Trials**: Recently completed Phase 1 trial for an anti-thymocyte globulin asset, focusing on T1D [4][12] - **Mechanism of Action**: The product aims to replicate the efficacy of rabbit antithymocyte globulin (thymoglobin) without the associated immunogenicity and serum sickness [12][15] - **Phase 2 SAFE Guard Study**: Planned to start in mid-2025, targeting newly diagnosed T1D patients within 100 days of diagnosis [42][56] Proprietary Technology - **Transchromosomic Cow Platform**: Unique in the world, allowing for the production of human IgG from genetically engineered cows [6][7] - **Advantages**: Higher plasma yield (60 times more than humans), robust immune response, and established infrastructure for animal care [9][10] Clinical Data Insights - **Phase 1 Trial Results**: - Doses ranged from 0.003 mg/kg to 2.5 mg/kg, with a focus on serum sickness and T cell markers [13][14] - Demonstrated activation of T cells leading to exhaustion signals without long-term lymphodepletion [14][18] - **Safety Profile**: No significant lymphodepletion observed; transient lymphopenia was expected and not clinically significant [22][24] Future Plans and Expectations - **Next Steps**: - Continue with Phase 2 study focusing on preservation of C peptide at one year [42] - Potential for redosing based on favorable safety and immunogenicity data [49][50] - **Expected Data Timeline**: Interim analysis expected within a year of trial start, with top-line data anticipated in mid-2027 [56][57] Market and Competitive Landscape - **Unique Positioning**: SAB Biotherapeutics is positioned as a leader in the development of human IgG therapies for autoimmune diseases, with a focus on unmet medical needs where existing rabbit products are not suitable [39][54] - **Physician Feedback**: Positive feedback from key opinion leaders (KOLs) regarding the preservation of Tregs and the dual exhaustion of CD4 and CD8 T cells [53][54] Additional Considerations - **Regulatory Path**: The product's safety profile and lack of immunogenicity are expected to facilitate regulatory approval [49][50] - **Broader Applications**: Potential future indications include scleroderma, lupus nephritis, and celiac disease, expanding the therapeutic scope beyond T1D [39][40]