SELLAS Life Sciences Reports AML Pipeline Milestones and $114 Million Capital Position Heading Into Pivotal 2026

SHERIDAN, WYOMING - April 14, 2026 - SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) reported full-year 2025 financial results on March 19, 2026, disclosing $71.8 million in cash and cash equivalents as of December 31, 2025, and an additional $42.6 million in warrant exercise proceeds received in Q1 2026. The New York-based biopharmaceutical company advanced two lead oncology candidates simultaneously: galinpepimut-S (GPS), a WT1-targeting cancer immunotherapeutic in a pivotal Phase 3 trial for acute myeloid leukemia (AML), and SLS009 (tambiciclib), a selective CDK9 inhibitor now enrolling in a Phase 2 first-line AML study. The combined clinical and financial momentum positions SELLAS for multiple potential data readouts before year-end 2026.

Business impact

SELLAS ended 2025 with a combined available capital base approaching $114 million when accounting for Q1 2026 warrant proceeds, providing runway to support concurrent Phase 2 and Phase 3 trial operations across the US and Europe. The warrant exercise proceeds signal ongoing investor participation and reduce near-term dilution risk relative to equity offerings. Capital efficiency is further supported by the IMPACT-AML agreement, under which a European collaborative network absorbs costs associated with site activation and patient enrollment across European centers - a structure that extends geographic reach without proportional capital outlay. Management characterized 2026 as a pivotal year for the company given the depth of near-term clinical catalysts across both programs.

GPS and SLS009 clinical advancement

The Phase 3 REGAL trial of GPS in AML is advancing toward final analysis, triggered upon reaching 80 events. GPS targets the Wilms tumor 1 (WT1) protein - ranked by the National Cancer Institute as a top immunotherapy priority and expressed in 20 or more cancer types - and is licensed globally from Memorial Sloan Kettering Cancer Center. On the SLS009 side, the first patient was enrolled in March 2026 in a randomized Phase 2 study (NCT04588922) designed for approximately 80 newly diagnosed AML patients unlikely to benefit from standard venetoclax/azacitidine therapy. Topline data from this trial are expected in Q4 2026. Positive Phase 2 data for SLS009 in relapsed/refractory AML had already been reported at ASH 2025, establishing a clinical foundation for the first-line expansion.

European expansion via IMPACT-AML

In January 2026, SELLAS entered an agreement with IMPACT-AML, a European collaborative initiative dedicated to advancing innovative AML treatments. Under the arrangement, the IMPACT-AML network conducts a clinical study of SLS009 and provides access to multiple European clinical sites and patient populations. US enrollment in the SLS009 first-line trial was planned for Q1 2026, with European enrollment anticipated in Q2 2026. The company's protocol incorporates predictive biomarker models and AI-assisted precision medicine tools to identify patients most likely to respond, specifically targeting a population with limited benefit from existing standard-of-care regimens.

Upcoming data and sector presence

Preclinical data for SLS009 are scheduled for presentation at the American Association for Cancer Research Annual Meeting, April 17-22, 2026, at the San Diego Convention Center. The data show that SLS009 lowers the apoptotic threshold in AML cells by suppressing critical survival pathways, including reduced MCL-1 expression and increased active caspase-3 levels. SLS009 is licensed from GenFleet Therapeutics (Shanghai), Inc., for territories outside Greater China, and SELLAS positions it as a potential best-in-class CDK9 inhibitor with reduced toxicity and increased potency compared to other CDK9 inhibitors in development.

Key facts:

  • $71.8 million cash as of December 31, 2025; $42.6 million in additional warrant exercise proceeds received in Q1 2026
  • Phase 3 REGAL trial of GPS in AML awaiting final analysis upon reaching 80 events
  • First patient enrolled in Phase 2 SLS009 first-line AML trial (NCT04588922) in March 2026; topline data expected Q4 2026
  • SLS009 preclinical data to be presented at AACR Annual Meeting, April 17-22, 2026, San Diego
  • IMPACT-AML agreement enables capital-efficient European site expansion for the SLS009 clinical program
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