SAB Biotherapeutics (SABS) investor relations material

Company overview and lead asset

• Lead asset SAB-142 is a multi-specific T-cell engager for autoimmune disease, in Phase IIb for newly diagnosed type 1 diabetes.

• SAB-142 is based on a proprietary Tc Bovine platform, enabling production of human anti-thymocyte globulin with long-term exclusivity.

• Management team has experience in drug approval, commercialization, and company transactions.

• Positive Phase I results in 2025 validated the mechanism of action and safety profile, enabling a $175M PIPE financing.

• Phase IIb pivotal trial (SAFEGUARD) launched, targeting newly diagnosed T1D patients.

Differentiation and clinical data

• SAB-142 is a human version of Thymoglobulin, offering similar efficacy but improved safety and redosability.

• Phase I data showed 0% serum sickness and durable T-cell exhaustion, with key markers PD-1 and TIGIT induced.

• SAB-142 preserves regulatory T cells (Tregs), unlike Tzield, which may contribute to superior efficacy.

• Dosing regimen is two days versus Tzield’s 12 days, offering significant patient convenience.

SAFEGUARD study design and progress

• SAFEGUARD is a Phase IIb trial in T1D patients within 100 days of diagnosis, ages 5–40, with three arms (high dose, low dose, placebo).

• Primary endpoint is one-year C-peptide preservation; secondary endpoints include HbA1c, Time in Range, hypoglycemic events, and insulin use.

• Study is 80% powered to show a 40% preservation effect on C-peptide, using historical data from the TN19 Thymoglobulin study.

• Enrollment is on track, with strong site and patient enthusiasm.