Reported Phase 1 clinical data, including healthy volunteer, redosing, and T1D cohorts supporting SAB-142's favorable safety profile, redosability, and continued clinical development
Raised $175 million in an oversubscribed private placement with leading institutional and strategic investors to fully fund SAFEGUARD
Strong cash position with operational runway through 2028
MIAMI, March 09, 2026 (GLOBE NEWSWIRE) -- SAB Biotherapeutics, Inc. (NASDAQ:SABS), a clinical-stage biopharmaceutical company developing human anti-thymocyte immunoglobulin (hATG) for type 1 diabetes (T1D) and other autoimmune diseases, today announced financial results for the full year 2025 and provided business highlights.
"2025 marked an important year of execution for SAB. We delivered Phase 1 clinical data for SAB-142, completed a $175 million oversubscribed financing with high quality investors including Sanofi, and advanced SAB-142 into our registrational Phase 2b SAFEGUARD study with the first patient dosed," said Samuel J. Reich, CEO, SAB BIO. "In 2026, our focus is on enrolling SAFEGUARD. We are encouraged by current momentum and remain on track to complete enrollment by year end with topline data expected in the second half of 2027. We also expect to share additional Phase 1 data and support the initiation of an investigator led study as we continue to build the clinical foundation for SAB-142 in T1D."
Recent Pipeline Achievements and Anticipated Milestones for SAB-142
Phase 2b SAFEGUARD Study
Initiated and dosed multiple patients in the SAFEGUARD (SAFety and Efficacy of human anti-thymocyte immunoGlobUlin SAB-142 ARresting progression of type 1 Diabetes) clinical trial of SAB-142 as a novel, potentially best-in-class, disease-modifying immunotherapeutic approach in development to treat T1D by delaying the progression of disease.
Activated multiple clinical trial sites in the U.S., Australia, and New Zealand.
On May 29, 2025, the Company held a constructive Type B meeting with the U.S. Food and Drug Administration (FDA).
The FDA provided guidance leading to alignment on the design and advancement of our Phase 2b SAFEGUARD study.
SAB confirmed its intent with the FDA to utilize the data from the SAFEGUARD study as supportive evidence for future regulatory approval.
Enrollment is ongoing and the Company is on track to complete enrollment in SAFEGUARD by the end of 2026 with topline data expected in 2H 2027.
Phase 1 Data in Healthy Volunteer, Redosing, and T1D Cohorts
Reported positive confirmatory clinical results from the Phase 1 study of SAB-142 in healthy volunteers, redosing, and T1D cohorts in December 2025.
Data confirmed SAB-142 does not cause serum sickness and has low/no immunogenicity at any dose and in all cohorts, including redosed healthy volunteers.
Transient lymphopenia, an on-target marker of target engagement and pharmacodynamic activity, was observed after dosing and rapidly corrected to baseline within ...
