SAB Biotherapeutics (SABS) investor relations material

Strategic vision and clinical focus

• Mission centers on transforming Type 1 Diabetes care by developing disease-modifying therapies, not just symptom management.

• Lead asset SAB-142 is a fully human anti-thymocyte immunoglobulin, aiming for long-term exclusivity via proprietary TcBovine platform.

• Targeting newly diagnosed Stage 3 Type 1 Diabetes patients, focusing on preserving beta cell function and insulin independence.

• Plans to expand into Stage 2 patients and those beyond 100 days post-diagnosis, broadening the addressable market.

• Chronic dosing model allows for patient accumulation over time, increasing market potential.

Clinical development and trial design

• Phase 1 study completed in 2024 showed SAB-142 did not cause serum sickness or anti-drug antibodies and enabled redosing.

• SAFEGUARD pivotal trial is a global, two-part study in newly diagnosed patients aged 5–40, with 159 participants and three arms (2.5 mg/kg, 1.5 mg/kg, placebo).

• Primary endpoint is C-peptide preservation at one year; secondary endpoint is HbA1c improvement.

• Study design includes age stratification and step-down enrollment from adults to pediatrics for safety.

• Enrollment expected to complete by end of 2026, with data readout in the second half of 2027.

Mechanism of action and differentiation

• SAB-142 induces T-cell exhaustion while preserving regulatory T-cells, promoting self-tolerance and beta cell preservation.

• Fully human design avoids serum sickness and immunogenicity issues seen with rabbit-derived Thymoglobulin, allowing for chronic redosing.

• Dose selection for pivotal trial based on Phase 1 data showing durable T-cell exhaustion at 1.5 and 2.5 mg/kg.