SABS - 1Q26; C-Peptide AUC Recognized as Surrogate Endpoint for Accelerated Approval; Phase IIb Registrational Study Progressing into Part B; Enrollment Completion by YE26

研报英文原文证据摘录

SABS - 1Q26; C-Peptide AUC Recognized as Surrogate Endpoint for Accelerated Approval; Phase IIb Registrational Study Progressing into Part B; Enrollment Completion by YE26

May 12, 2026

Yatin Suneja yatin.suneja@guggenheimpartners.com SABS - 1Q26; C-Peptide AUC Recognized as

212 518 9565 Surrogate Endpoint for Accelerated Approval; Phase

Iris Gao, Ph.D.

iris.gao@guggenheimpartners.com IIb Registrational Study Progressing into Part B;

212 518 9013 Enrollment Completion by YE26 Min Lee, Ph.D.

min.lee@guggenheimpartners.com

212 823 6744 Key Message: SABS reported 1Q26 earnings with summarized corporate updates and

Delma Caiati, M.D., Ph.D. clinical development progress. Our key takeaways: (1) SABS announced the receipt of

delma.caiati@guggenheimpartners.com written confirmation from the FDA that C-peptide AUC is acceptable as a surrogate

617 859 4606 endpoint to support accelerated approval, which, we agree with the company, can

de-risk regulatory uncertainty in new onset T1D where no therapeutic is approved to Eddie Hickman, Ph.D.

eddie.hickman@guggenheimpartners.com date. (2) The ongoing registrational Phase IIb SAFEGUARD study (n=159; Exhibit 1)

212 518 9904 of SAB-142, a fully human anti-thymocyte globulin (hATG), in new onset Stage 3 T1D

is progressing well. In 1Q26, SABS completed enrollment of 12 adult patients in the

dose-ranging Part A, and initiated the randomized, double-blind, placebo-controlled

Part B, which will also enroll pediatric and adolescent patients. The Data Monitoring

SABS BUY Committeeenrollment completion(DMC) hasandapprovedtopline thedatafirstarestepdownon track fortoYE26patientsandages2H27,12respectively,and older. Fullper

SAB Biotherapeutics, Inc. mgmt. (3) SABS previously presented T1D patient data from the Phase I study at IDS