SAB Biotherapeutics (SABS) investor relations material

Strategic vision and clinical focus

• Mission centers on changing the course of type 1 diabetes with new treatments, not just symptom management.

• Lead drug SAB-142 is a fully human anti-thymocyte immunoglobulin in pivotal phase II-B, aiming to delay or halt disease progression.

• Platform technology uses transchromosomic cows to produce fully human IgG, providing multi-level IP protection and no biosimilar pathway.

• Management team has deep biotech expertise, supporting value creation and patient impact.

• 2025 marked a pivotal year with positive phase I results and full funding for the pivotal trial.

Clinical development and trial design

• Phase I trial showed no serum sickness, no immunogenicity, and reliable redosing, confirming safety and mechanism of action.

• SAB-142 induces T cell exhaustion while preserving Tregs, differentiating it from competitors and supporting best-in-class claims.

• SafeGUARD phase II-B trial is enrolling globally, targeting newly diagnosed patients aged 5–40, with dosing every six months.

• Primary endpoint is stimulated C-peptide at one year; secondary endpoint is HbA1C.

• FDA has agreed the SafeGUARD study is pivotal; company expects data readout in late 2027.

Market opportunity and competitive landscape

• Type 1 diabetes is a multi-billion-dollar market with 10 million affected globally and 64,000 new US diagnoses annually.

• Stage 3 patients represent the largest market, with no current drug available; SAB-142 aims for significant penetration.

• Tzield is approved for stage 2 but requires burdensome dosing; SAB-142 offers easier regimen and potential superior efficacy.

• SAB-142 can be redosed, unlike Thymoglobulin and Tzield, addressing chronic disease needs.

• Plans for future label expansion into stage 2 and other autoimmune indications.