SAB Biotherapeutics (SABS) investor relations material

Company and product overview

• Clinical-stage biotech focused on a human anti-thymocyte immunoglobulin for newly diagnosed type 1 diabetes patients.

• Lead asset entering a pivotal phase II-B clinical trial, expected to be best-in-class based on comparative data.

Differentiation and mechanism of action

• Rabbit ATG, the current standard, is effective but causes serum sickness and cannot be redosed due to immunogenicity.

• Human ATG induces durable T cell exhaustion without immunogenicity, allowing for redosing.

• MELD study data show efficacy at lower doses without lymphodepletion, decoupling efficacy from lymphodepletion.

• Human ATG preserves Tregs and does not cause lymphodepletion, supporting a similar mechanism to rabbit ATG.

Regulatory and clinical trial design

• FDA increasingly accepts C-peptide as a sufficient endpoint for approval, supported by recent regulatory trends and advocacy.

• Current pivotal trial stratifies by age and baseline C-peptide, with a run-in for adult safety before including adolescents and children.

• Two active dose levels are being tested, aiming for optimal efficacy with minimal side effects.

• C-peptide measured via two-hour mixed meal tolerance test at multiple time points, with primary endpoint at 12 months.

• Study powered at 80% to detect a 40% effect size, using raw data from prior TN19 study for modeling.

• HbA1c is a secondary endpoint, with any reduction considered clinically meaningful.