SAB Biotherapeutics Secures $95M, FDA Accepts C-Peptide Surrogate in SAFEGUARD Trial
SABS•SAB Biotherapeutics enrolled Part A of its 159-patient SAFEGUARD Phase 2b T1D trial and initiated Part B, projecting completion by year-end 2026 with FDA acceptance of C-peptide AUC as a surrogate endpoint. The company raised $95 million and held $217.6 million in cash at March 31, funding operations through 2028.
1. Q1 Financial Results
For the quarter ended March 31, SAB Biotherapeutics reported cash, cash equivalents and available-for-sale securities of $217.6 million, research and development expenses of $13.4 million (versus $7.7 million year-ago) and general and administrative expenses of $6.6 million (versus $3.1 million), resulting in a net loss of $18.9 million.
2. SAFEGUARD Trial Progress
The Phase 2b SAFEGUARD trial activated multiple sites globally, fully enrolled Part A’s 12 adult patients and launched Part B’s 147 participants. Enrollment is on schedule to finish by year-end 2026, targeting topline data in 2H 2027, and the FDA confirmed C-peptide AUC as an acceptable surrogate endpoint.
3. Phase 1 Data Highlights
Phase 1 data for SAB-142 showed three of four treated participants maintained or improved C-peptide levels at Day 120 and mean glycemic time in range rose from 73% to 85% without higher insulin use, demonstrating the therapy’s mechanism of action and favorable safety profile.
4. Funding and Manufacturing
On March 19, the company closed a public offering and over-allotment, raising approximately $95 million in gross proceeds, and on April 29 secured a multi-year manufacturing agreement with Emergent BioSolutions to support clinical and future commercial production of SAB-142.
