SAB Biotherapeutics (SABS) investor relations material

Executive summary

• SAFEGUARD adult and adolescent cohorts are fully enrolled; pediatric enrollment is underway, with total enrollment expected in Q4 2026 and topline data in H2 2027.

• FDA granted SAB-142 Fast Track designation in October 2026 for new-onset Stage 3 T1D, enabling closer agency interaction but not ensuring approval or faster review.

• SAB-142 is a fully human anti-thymocyte immunoglobulin intended to preserve insulin-producing beta cells; its design may support long-term redosing with lower immunogenicity.

Financial highlights

• Q3 revenue was $0; operating expenses were $25.9M, up 104.3% YoY, and operating loss was $25.9M.

• Q3 R&D expense was $18.1M vs. $9.0M, mainly from SAFEGUARD clinical costs and headcount; G&A was $7.8M vs. $3.7M, reflecting personnel costs and stock compensation.

• Q3 net loss was $22.3M vs. net income of $45.4M in Q3 2025; prior-year results included a $62.0M warrant fair-value gain, while other income was $3.6M vs. $58.1M.

• Cash, cash equivalents and investment securities totaled $205.3M at September 30, 2026, including $13.4M gross proceeds from warrant exercises.

Outlook and guidance

• SAFEGUARD enrollment is expected to be completed in Q4 2026, with topline data expected in H2 2027.

• PRISE-hATG expects to dose its first patient in Q4 2026; it studies SAB-142 in patients 100 days to two years after diagnosis and may support a future label expansion.

• Cash resources are projected to fund operations through 2028, including planned PRISE costs and SAB-142 development and pre-commercial activities.

• R&D and G&A expenses are expected to rise with clinical development, hiring, manufacturing and potential commercialization preparation.