SAB Biotherapeutics (SABS) investor relations material

Clinical development progress

• SAFEGUARD pivotal study for SAB-142 is progressing well, with last patient enrollment expected in Q4 2026.

• Over 60 sites are activated, and enrollment has accelerated by including younger pediatric patients.

• The primary endpoint is C-peptide preservation at 48 weeks, with a focus on enrolling sufficient pediatric patients for statistical power.

• Top-line data from SAFEGUARD is anticipated in the second half of 2027.

• A long-term extension will provide two-year durability data, supporting chronic dosing.

Regulatory and approval strategy

• FDA accepts C-peptide preservation as a surrogate endpoint for accelerated approval in type 1 diabetes.

• Full approval will require demonstration of clinical benefit, with HbA1c reduction as a key secondary endpoint.

• Other secondary endpoints include insulin use, hypoglycemic events, and time in glucose range.

• If only the primary endpoint is met, accelerated approval remains an option, with a commitment to show clinical benefit post-approval.

Commercial opportunity and strategy

• U.S. market opportunity for SAFEGUARD is estimated at $4 billion, with potential to reach double-digit billions with label expansions.

• PRIZE trial could double the eligible patient population upon label expansion, providing an initial market surge.

• Redosing every six months and long-term use could lead to a compounding patient base and revenue.

• Initial commercial focus will be on academic centers and KOLs, with expansion to community endocrinologists supported by medical education.