SELLAS Life Sciences Nears Pivotal Phase 3 REGAL Trial Readout with 78 Events, Reports Strong Cash Position

summarizeSummary

SELLAS Life Sciences announced that its pivotal Phase 3 REGAL trial is on the cusp of final data analysis with 78 of 80 events recorded, alongside reporting a strong cash position of $114.6 million (pro forma).

check_boxKey Events

• Pivotal Phase 3 REGAL Trial Nearing Readout

  The Contract Research Organization for the pivotal Phase 3 REGAL trial of Galinpepimut-S (GPS) in AML informed the company that 78 events have occurred as of May 11, 2026. Final analysis will be conducted following the 80th event, signaling an imminent data readout.

• Strong Cash Position Reported

  SELLAS reported $107.1 million in cash and cash equivalents as of March 31, 2026, with an additional $7.5 million received in Q2 2026 to date through warrant exercises, providing a robust financial runway.

• SLS009 Phase 2 Trial Progressing

  Ongoing dosing of patients in the Phase 2 trial of SLS009 in newly diagnosed first-line AML is underway, with topline data expected in Q4 2026.

• Q1 2026 Financial Results

  The company reported a net loss of $8.4 million for the first quarter of 2026, compared to $5.8 million for the same period in 2025, reflecting increased R&D and G&A expenses for clinical development.

auto_awesomeAnalysis

This filing provides a critical update on SELLAS Life Sciences' pivotal Phase 3 REGAL trial, indicating that 78 of the 80 required events have occurred. This means the final data analysis and readout for this key trial in Acute Myeloid Leukemia (AML) are imminent, representing a major value inflection point for the company. Additionally, the company reported a robust cash position of $107.1 million as of March 31, 2026, further bolstered by $7.5 million from warrant exercises in Q2 2026, providing a strong financial runway as it approaches these significant clinical milestones.