SELLAS Life Sciences' Phase 3 REGAL AML Trial Hits 80th Survival Event, Triggering Final Analysis for Galinpepimut-S

SELLAS Life Sciences Group (NASDAQ: SLS) said its pivotal Phase 3 REGAL trial of galinpepimut-S (GPS) in acute myeloid leukaemia has reached the pre-specified 80th overall survival event, triggering the study's final analysis. The company will now lock the database, unblind the data and run the primary endpoint statistical analysis, with preliminary topline results expected later this quarter. REGAL is a randomized registrational trial testing GPS as maintenance therapy in AML patients who achieved a second complete remission. The primary endpoint is overall survival; secondary endpoints include leukaemia-free survival. In December 2025, SELLAS reported 72 events recorded as of December 26, 2025, with the study still fully blinded. GPS, licensed from Memorial Sloan Kettering Cancer Center, targets the WT1 protein. SELLAS reported $138.3 million in cash and equivalents as of June 30, 2026. The stock closed Wednesday at $10.38, down 14.71%, and fell another 0.52% to $10.33 in pre-market trading, within a 52-week range of $1.39 to $15.88.