SAB-142 - (SAFEGUARD)

October 13, 2026: SAB Biotherapeutics, Inc. (NASDAQ: SABS) said the FDA granted Fast Track designation to SAB-142 for treatment of individuals with new-onset Stage 3 type 1 diabetes. The company described SAB-142 as a potentially disease-modifying fully human anti-thymocyte immunoglobulin (hATG), and said the designation recognizes its potential to address an unmet medical need and could facilitate development and expedite review.

SAB-142 is being evaluated in the registrational Phase 2b SAFEGUARD study in patients within 100 days of a Stage 3 T1D diagnosis. Enrollment is expected to be completed in Q4 2026, with topline data anticipated in 2H 2027. The program is also supported by the investigator-led Phase 3 PRISE-hATG study, designed to evaluate SAB-142 in people with Stage 3 T1D from 100 days to two years after diagnosis.