SAB Biotherapeutics Announces Confirmatory Data From Phase 1 Trial Of SAB-142 In Single- And Multiple-Ascending Dose Among Healthy Volunteers, Including Re-Dosed Cohort, And T1D Patients

• Phase 1 data confirms SAB-142 does not cause serum sickness and has low/no immunogenicity at any dose and in all cohorts, including redosed healthy volunteers
   
• Study results support the chronic dosing of SAB-142 in an outpatient setting for the treatment of stage 3 autoimmune type 1 diabetes
   
• Phase 2b SAFEGUARD trial underway and recruiting at multiple sites around the world
   

MIAMI, Dec. 17, 2025 (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 positive, confirmatory data from a Phase 1 trial of SAB-142 in a single- and multiple-ascending dose among healthy volunteers (n=62), including a re-dosed cohort, and T1D patients (n=6). The study met its primary objectives to establish a safety profile and characterize pharmacodynamic activity enabling SAB-142 to advance to Phase 2b clinical development in the SAFety and Efficacy of human anti-thymocyte immunoGlobUlin SAB-142 ARresting progression of type 1 Diabetes (SAFEGUARD) clinical trial, now underway.

In the Phase 1 trial, nine (9) cohorts of healthy volunteers (HVs) and one (1) cohort of T1D patients were dosed with a single 0.03-4.5mg/kg dose or multiple doses of SAB-142.

SAB-142 was well-tolerated in both healthy volunteers and T1D patients. SAB-142 demonstrates a safety profile superior to rabbit anti-thymocyte immunoglobulin (rATG) as the data from the Phase 1 trial confirmed SAB-142 does not cause serum sickness (0%, N=0/68) and there were no adverse events (AEs) associated with anti-drug antibodies (ADAs; 0%, N=0/68) at any dose in any cohort, including in the redosed HVs.

In all treated participants, there were no drug-related serious adverse events (SAE). Most AEs were mild and associated with day 1-2 infusions, with only Grade 1 flu-like symptoms and transient infusion-site reactions including pruritus and tenderness. The most common AE was headache, which is consistent with typical AEs for T-cell modifying therapies.