SAB Biotherapeutics, Inc. 8-K

What Happened

• On March 10, 2026, SAB Biotherapeutics (SAB BIO) issued a press release and presentation reporting additional data from its Phase 1 HUMAN anti‑thymocyte biologic first‑in‑MAN trial of SAB‑142. The company reported that adult patients with established type 1 diabetes (T1D) in the trial showed early signals consistent with preservation of C‑peptide (a measure of residual insulin-producing beta‑cell function) through Day 120 after dosing.
• The Phase 1 T1D cohort included six adults (ages 19–40): four received SAB‑142 at 2.5 mg/kg and two received placebo. All participants had Stage 3 T1D (diagnosed 28–40 months prior), residual beta function at baseline (C‑peptide >0.2 nmol/L), and at least one T1D autoantibody. SAB‑142–treated participants (n=4) showed no decrease in C‑peptide at Day 120 vs baseline (mean values increased above baseline), while the placebo participant who completed Day 120 showed a decline consistent with expected disease progression. One placebo subject discontinued early for personal reasons.
• The company compared results to a modeled historical placebo trajectory (TN19 study, Haller et al., Diabetes 2019) and reported divergence by Day 120, which SAB BIO says supports a pharmacodynamic effect consistent with beta‑cell preservation. The press release and presentation are furnished as Exhibits 99.1 and 99.2 to the 8‑K.

Key Details

• Date filed: March 10, 2026 (8‑K; press release and presentation furnished).
• T1D cohort size: 6 adults total — 4 treated (SAB‑142 2.5 mg/kg), 2 placebo (1 placebo completed Day 120).
• Primary efficacy timing reported: End of Study Day 120 post‑administration (MMTT C‑peptide AUC endpoint).
• Comparison: Divergence from both study placebo arm and modeled TN19 placebo trajectory by Day 120 (TN19 slope used: –0.6206 per week estimate).

Why It Matters

• Preservation of C‑peptide is an objective sign of maintained beta‑cell function; early signals in this Phase 1 cohort suggest SAB‑142 may have the intended pharmacodynamic effect in adults with established T1D.
• These are preliminary, small‑sample Phase 1 results (n=6) and are not conclusive evidence of clinical benefit; investors should view them as early clinical signals that may support further development but subject to the usual clinical and regulatory risks.
• The company included standard forward‑looking disclaimers; additional details and risks are available in SAB BIO’s SEC filings and investor materials.