SAB Biotherapeutics (SABS) Citigroup’s Biopharma Back to School Summit 2026 summary

SAB-142 approach

• Fully human multispecific IgG immunomodulator designed to target immune cells involved in beta-cell destruction while preserving regulatory T cells.

• Treatment goal is durable beta-cell preservation through safe, predictable redosing, rather than a one-time immune reset; potential use spans presymptomatic through established-onset T1D.

Early clinical signals

• Early C-peptide preservation signals were reported in T1D patients more than 2 years from diagnosis.

• Single and repeat dosing showed low immunogenicity, preserved Tregs, an increased T-cell exhaustion signature, and predictable PK upon redosing.

• Safety findings included no lymphodepletion, cytopenias, serum sickness, or WBC/RBC decrease; CRS was Grade 1/mild. Repeat dosing may support a twice-yearly regimen.

Clinical development progress

• SAFEGUARD plans 159 patients ages 5–40 with new-onset Stage 3 T1D; Part A has 12 patients and Part B has 147 across dose-ranging and placebo-controlled arms.

• More than 60 sites are activated, enrollment has accelerated with younger pediatric patients included, and last patient enrollment is expected in Q4 2026.

• SAFEGUARD dosing is IV, with induction split over two days and 1.5 mg/kg maintenance every six months; the primary endpoint is stimulated C-peptide by 2-hour MMTT at 12 months (48 weeks).

• Top-line SAFEGUARD data are expected in 2H 2027; a long-term extension is planned to provide two-year durability data and support chronic dosing.

• PRISE extends evaluation to Stage 3 T1D diagnosed up to 2 years earlier, with 108 patients ages 5–40 across three cohorts; primary endpoint is stimulated C-peptide at 12 months.