Every 8-K that SAB Biotherapeutics, Inc. Warrant (SABSW) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow SABSW and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full SABSW filings page.
SAB Biotherapeutics, Inc. (SABS) announced that the U.S. FDA granted Fast Track designation to SAB-142, an immunotherapy being developed for people with new-onset Stage 3 type 1 diabetes (T1D).
SAB-142 is being evaluated in the registrational Phase 2b SAFEGUARD study in people within 100 days of diagnosis; enrollment is expected to be completed in Q4 2026, with topline data anticipated in 2H 2027. An investigator-led Phase 3 study, PRISE-hATG, is designed to evaluate SAB-142 in people with Stage 3 T1D from 100 days to two years following diagnosis.
SAB Biotherapeutics, Inc. filed a current report describing a new grant-funded clinical study of its lead candidate SAB-142 in type 1 diabetes. Breakthrough T1D has awarded a grant to support the PRISE‑hATG trial, led by Dr. Michael J. Haller at the University of Florida.
The PRISE‑hATG study will evaluate SAB‑142 in patients with Stage 3 type 1 diabetes who are between 100 days and two years from diagnosis, a group that typically falls outside earlier-stage trials. SAB BIO will co-fund the trial, which is designed to assess whether SAB‑142 can preserve C‑peptide and modulate immune responses. The study complements SAB BIO’s ongoing Phase 2b SAFEGUARD trial of SAB‑142 in newly diagnosed Stage 3 patients.
SAB Biotherapeutics, Inc. held its 2026 Annual Meeting of Stockholders on June 18, 2026. A total of 59,349,534 shares were present in person or by proxy out of 77,966,409 shares entitled to vote, representing approximately 76.12% of the outstanding common stock and establishing a quorum.
Shareholders elected four Class II directors for three-year terms: David Zaccardelli, Pharm.D., David Link, MBA, Katie Ellias, and Andrew Moin. Each received over 44 million votes in favor, with broker non-votes of 10,994,436 reported for each nominee.
Stockholders also ratified EisnerAmper LLP as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2026, with 59,319,363 votes for, 3,373 against, and 26,798 abstentions.
SAB Biotherapeutics, Inc. entered into a Master Manufacturing Services Agreement with Emergent BioSolutions Canada Inc. for clinical and commercial production of its SAB-142 product at Emergent’s Canadian facility. The agreement becomes a long-term framework once SAB-142 receives U.S. FDA approval.
After any FDA approval, the agreement runs for five years and includes a minimum aggregate spend of $36 million over that post-approval term. Emergent has the exclusive right to manufacture SAB-142 during the term, while SAB Biotherapeutics may use alternative sources only when Emergent cannot or declines to supply.
The agreement includes multiple termination rights, including for insolvency, non-payment, material breach, mutual agreement, or extended force majeure. If Emergent terminates due to SAB Biotherapeutics’ insolvency, non-payment, or material breach, SAB Biotherapeutics must pay Emergent an amount equal to the minimum annual aggregate spend for each remaining calendar year, less saved costs.
SAB Biotherapeutics reported new Phase 1 data for its fully human anti-thymocyte globulin candidate SAB-142 in adults with established type 1 diabetes. In the six-person cohort, four participants received SAB-142 and two received placebo.
All four treated participants preserved C-peptide, with three classified as super responders showing increases above baseline through Day 120, while the placebo patient showed a decline consistent with disease progression. Treated participants’ continuous glucose monitoring time in range improved from 73% at baseline to 85% at Day 120 without higher exogenous insulin use.
Biomarker data indicated CD4+ T conventional cell exhaustion without immunodepletion, supporting SAB-142’s intended mechanism. A registrational Phase 2b SAFEGUARD trial in newly diagnosed Stage 3 type 1 diabetes is ongoing, with topline data expected in the second half of 2027.
SAB Biotherapeutics (SAB BIO) reported additional Phase 1 data for its lead Type 1 diabetes therapy SAB-142. In a small cohort of six adults with established Stage 3 T1D, four participants receiving SAB-142 at 2.5 mg/kg showed preserved or increased C-peptide levels at Day 120, while the single placebo completer showed a decline consistent with expected disease progression.
The company highlights biomarker evidence of T‑cell exhaustion supporting the drug’s intended mechanism and notes a previously established Phase 1 safety profile without serum sickness and with transient, reversible lymphopenia. These results supported advancing SAB-142 into the global registrational Phase 2b SAFEGUARD trial in newly diagnosed Stage 3 T1D patients, with topline data planned for the second half of 2027.