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]