SAB BIO Reports Third Quarter Financial Results and Recent Business Highlights

Core Insights - SAB Biotherapeutics, Inc. has made significant progress in its clinical plans, particularly with the initiation of the registrational Phase 2b SAFEGUARD study for its lead candidate SAB-142 targeting type 1 diabetes (T1D) [2][5] - The company has activated multiple clinical trial sites globally and is on track to dose the first patient by the end of the year [5][6] - Recent presentations at major conferences showcased favorable safety data and a competitive dosing regimen for SAB-142, reinforcing its potential as a best-in-class treatment for Stage 3 T1D [2][6] Recent Highlights and Achievements - Initiated the registrational Phase 2b SAFEGUARD trial of SAB-142 in new-onset, Stage 3 autoimmune T1D patients [5][6] - Multiple trial sites activated in the US, Australia, and New Zealand, with ongoing enrollment [6] - Presented key data at EASD and ISPAD conferences, highlighting the favorable safety profile and immunomodulatory effects of SAB-142 [6] Clinical Data - The Phase 1 study results demonstrated a multi-specific mechanism of action with sustained immunomodulation [6] - Safety data indicated no serum sickness or anti-drug antibodies at the target dose [6] - The MELD-ATG study data presented at EASD further validated the mechanism of action for SAB-142, showing statistically significant preservation of C-peptide and improvement in glycemic control [6] Financial Results - As of September 30, 2025, the company reported cash, cash equivalents, and available-for-sale securities totaling $161.5 million, a significant increase from $20.8 million at the end of 2024 [11] - Research and development expenses for Q3 2025 were $9.0 million, up from $7.8 million in Q3 2024, reflecting ongoing investments in the SAB-142 program [11] - The company reported a net income of $45.4 million for Q3 2025, compared to a net loss of $10.3 million in Q3 2024 [11]