3D MEDICINES (01244): 3D189 Global Pivotal Phase III REGAL Trial Reaches Prespecified Number of Events

3D MEDICINES (01244) announced the latest significant progress on 3D189 (Galinpepimut-S, GPS), a collaborative project with SELLAS Life Sciences Group, Inc. (SELLAS). 3D189 is the company's second product approaching commercialization, an investigational therapy for the treatment of acute myeloid leukemia (AML), and if approved, it will become the world's first WT1 cancer vaccine. The company obtained exclusive development and commercialization rights to 3D189 in Greater China in 2020. As of October 28, 2026, the pivotal Phase III REGAL trial evaluating GPS in AML patients has reached the prespecified 80 events (deaths), triggering the final analysis of the study. The REGAL trial is an event-driven overall survival study. Following the 80th event, SELLAS will conduct database lock, unblinding of study data, and statistical analysis of the primary endpoint data. After completion of this analysis, SELLAS will, in accordance with the trial's prespecified Statistical Analysis Plan (SAP), announce the preliminary top-line results for the trial's primary endpoint this quarter.