SELLAS Life Sciences Group, Inc. (SLS) reported first-quarter 2026 financial results and highlighted progress across its late-stage oncology pipeline, as the company moves closer to a major clinical milestone in its pivotal Phase 3 REGAL trial in acute myeloid leukemia.
The company said 78 of the 80 required events in the REGAL study have now occurred, bringing SELLAS within reach of the final analysis that will determine whether its lead immunotherapy, Galinpepimut-S (GPS), can improve outcomes for patients with relapsed AML.
Financial Results
SELLAS reported a net loss of $8.4 million, or $0.05 basic and diluted loss per share for the first quarter of 2026, compared with a net loss of $5.8 million, or $0.07 basic and diluted loss per share in the same quarter of 2025.
The company attributed the higher loss primarily to increased research and development spending tied to the REGAL trial and preparation for a potential biologics license application.
R&D expenses rose to $5.1 million, up from $3.2 million in Q1 2025, driven by higher manufacturing, consulting, and clinical trial costs.
G&A expenses increased to $4.1 million, compared with $2.9 million a year earlier, reflecting higher professional fees and stock-based compensation.
SELLAS ended the quarter with $107.1 million in cash and equivalents, supported by warrant exercises that added another $7.5 million early in Q2 2026.
REGAL Phase 3 Trial Approaches Final Analysis
The pivotal Phase 3 REGAL trial is evaluating GPS in AML patients who achieved complete remission after second-line salvage therapy. The study's final analysis will be triggered once 80 events (deaths) occur.
As of May 11, 2026, 78 events had been recorded, with SELLAS remaining blinded to outcomes until the database lock and statistical review are completed.
The company said it will announce when the 80th event occurs and expects the readout to be a major catalyst for the program.
SLS009 Advances in Earlier-Line AML
SELLAS is also progressing SLS009 (tambiciclib), a selective CDK9 inhibitor designed to block cancer cell survival pathways.
Key updates include:
-An 80-patient Phase 2 study in newly diagnosed, first-line AML patients has begun dosing. Topline data are expected in Q4 2026.
-Preclinical data at AACR showed SLS009 induced apoptosis in AML cell lines, including those with high-risk ASXL1 and TP53 mutations, and reduced MCL-1 and survivin levels within hours of treatment.
CEO Angelos Stergiou said the company is "entering an exciting time" with two programs advancing toward meaningful clinical milestones.
SLS has traded between $1.39 and $6.14 over the past year. The stock closed Tuesday's trading at $5.22, down 0.57%. During overnight trading, the stock traded at $6.09, up 16.67%.
For comments and feedback contact: editorial@rttnews.com
Business News
May 08, 2026 15:50 ET Manufacturing and services sector survey results and labor market data from main economies were the highlight on the economics news front this week. Factory orders and jobs report dominated the news flow in the U.S. Similarly, industrial production data from German garnered attention in Europe. In Asia, purchasing managers’ survey results from China and the central bank decision from Australia were in focus.