SELLAS pivots on two AML bets: GPS Phase 3 REGAL final analysis and SLS009 first-line trial define whether either program reaches approval

SELLAS Life Sciences is a clinical-stage company developing two treatments for acute myeloid leukemia: GPS, a peptide vaccine not yet approved for maintenance AML patients, and SLS009, a targeted cancer drug not yet approved for newly diagnosed AML.

GPS is a peptide cancer vaccine in maintenance AML, with a Phase 3 REGAL trial at 78 of 80 pre-specified events and final analysis imminent. The thesis resolves on whether GPS demonstrates a statistically significant overall survival benefit in the REGAL final analysis. If GPS fails, the company depends entirely on SLS009 Phase 2 first-line data, where venetoclax-based combinations including approved ven-aza already dominate newly diagnosed AML.