When will SLS begin and conclude phase 3 trials

SELLAS Life Sciences (SLS) is currently in the process of conducting a Phase 3 clinical trial for its product GPS in acute myeloid leukemia (AML). The company has announced a positive interim analysis result for the REGAL trial, which has surpassed the results from the previous Phase 2 study.

1. **Interim Analysis Completion**: The interim analysis for the Phase 3 REGAL trial was completed in January 2025, and it successfully passed the event-driven (60 deaths) interim analysis for efficacy, futility, and safety. The Independent Data Monitoring Committee (IDMC) recommended continuation of the clinical trial without modification.
2. **Final Analysis and Timeline**: The final analysis for the Phase 3 REGAL trial is planned to be conducted once 80 events (deaths) are reached. SELLAS anticipates that 80 events will be reached in 2025.
3. **Next Steps**: Following the completion of the final analysis, SELLAS may submit the data to regulatory agencies for review, which could lead to potential approval for the treatment of AML. The exact timeline for the final analysis and potential approval will depend on various factors, including the progress of the trial and the regulatory review process.

In summary, SLS has already completed the interim analysis for its Phase 3 trial and is awaiting the final analysis, which is expected to be conducted by the end of 2025. The timeline for the final analysis and potential approval will depend on the progress of the trial and regulatory review.