SAB Biotherapeutics (SABS) investor relations material

Executive summary

• SAB-142, a fully human anti-thymocyte immunoglobulin, is the lead candidate for type 1 diabetes, advancing in the phase II-B SAFEGUARD trial with positive phase I data showing C-peptide preservation, improved glycemic control, and a favorable safety profile.

• SAFEGUARD trial enrollment is on track globally, with Part A (dose-ranging in adults) completed and Part B (randomized, placebo-controlled) enrolling pediatric, adolescent, and adult patients; completion is expected by year-end 2026 and topline data in the second half of 2027.

• FDA confirmed C-peptide as a surrogate endpoint for accelerated approval, de-risking the regulatory path.

• Proprietary platform enables production of disease-targeted hIgG without human plasma donors, providing a competitive barrier.

• Manufacturing agreement with Emergent BioSolutions positions the company for clinical and commercial readiness.

Financial highlights

• Ended Q1 2026 with $217.6 million in cash, cash equivalents, and available-for-sale securities, supporting operations through 2028.

• Completed a public offering in March 2026, raising $95 million in gross proceeds and $86.4 million in net proceeds, with an additional $7.2 million from underwriters' option.

• R&D expenses were $13.4 million in Q1 2026, up 74–75% year-over-year, reflecting increased investment in SAB-142 and SAFEGUARD.

• G&A expenses rose to $6.6 million in Q1 2026, up 112–113% year-over-year, mainly due to higher stock-based compensation, payroll, and personnel costs.

• Net loss was $18.9 million for Q1 2026, compared to $5.2 million in Q1 2025.

Outlook and guidance

• SAFEGUARD enrollment expected to complete by year-end 2026, with top-line data anticipated in the second half of 2027.

• Operational runway secured through 2028, supporting clinical and pre-commercial activities.

• Plans to pursue global regulatory approvals, initially focusing on the U.S. and Europe.

• Anticipates continued losses as development and commercialization efforts progress; may seek additional funding through equity, debt, or collaborations.