SELLAS Life Sciences Nears Pivotal Trial Readout As Leukemia Pipeline Progresses

SELLAS Life Sciences Group Inc. (NASDAQ:SLS) reported first-quarter (Q1) 2026 financial results on Tuesday while highlighting progress across its acute myeloid leukemia (AML) pipeline. CEO Angelos Stergiou said the company continued advancing its clinical programs during the quarter while preparing for the anticipated data readout from its pivotal Phase 3 REGAL study. SELLAS will release the upcoming data after the study reaches its pre-specified 80th event threshold — a major milestone for the company. Read Also: AstraZeneca's Rare Disease Drug Shows Reduced Dependence On Calcium Supplements REGAL Trial Approaches Final Event Threshold SELLAS said the ongoing Phase 3 REGAL trial is evaluating GPS in AML patients who achieved complete remission following second-line salvage therapy. As of May 11, the study had recorded 78 events. Reaching 80 events will initiate database lock procedures, blinded data review, statistical analysis, and eventual topline disclosure. The company said it plans to provide another update once the final event threshold has been reached. SLS009 Expands Into Earlier-Line AML Treatment SELLAS also highlighted progress with SLS009, including the launch of an 80-patient Phase 2 study in newly diagnosed AML patients considered unlikely to benefit from standard therapies such as AZA/VEN treatment. Topline data from the study are expected in the fourth quarter of 2026. The company additionally pointed to preclinical findings presented at the 2026 American Association for Cancer Research meeting, showing that SLS009 promoted apoptosis in AML cell lines, including high-risk TP53 and ASXL1-mutant subtypes. According to SELLAS, the data also showed reductions in MCL-1 and surviving levels following treatment. SELLAS Reports Higher Expenses And Wider Loss R&D expenses rose to $5.1 million in the first quarter from $3.2 million a year earlier, primarily due to manufacturing, regulatory consulting, and clinical trial costs tied to potential preparation for a Biologics License Application for GPS. General and administrative expenses increased to $4.1 million from $2.9 million in the prior-year quarter. SELLAS reported a net loss of $8.4 million, or $0.05 per share, compared with a net loss of $5.8 million, or $0.07 per share, in the Q1 of 2025. The company ended the quarter with approximately $107.1 million in cash and cash equivalents. SELLAS also said it received an additional $7.5 million after quarter-end from the exercise of previously outstanding warrants. SLS Price Action: SELLAS Life Sciences Gr shares were up 19.92% at $6.26 at the time of publication on Wednesday, according to Benzinga Pro. Over the past month, SLS has gained about 31.8% versus a 8.8% rise in the S&P 500 and is up roughly 41% year-to-date compared to the index’s 7.5% gain. Read Also: Adam Schiff Accuses CFTC Chair Mike Selig Of 'Duplicitous' Behavior Over Sports Prediction Markets Image via Shutterstock/ Yomal2233