SELLAS Adds SLS009 Pancreas Work as REGAL Near Readout

The Tip Desk · August 11, 2026 · 3 min read

Cash and cash equivalents stood at $138.3 million as of June 30, 2026, after the late-stage biopharma company posted a $9.6 million net loss, or $0.05 a share, in the second quarter.

SELLAS Life Sciences Group (SLS), a late-stage clinical biopharmaceutical company developing cancer therapies, said it is approaching the prespecified 80th event in the Phase 3 REGAL trial of galinpepimut-S (GPS) in acute myeloid leukemia, the trigger for the final efficacy analysis and, if successful, a potential biologics license application.

President and Chief Executive Officer Angelos Stergiou said the second quarter was an important period of execution as the company advanced both GPS and SLS009. The company said it will announce when the 80th event occurs, which will trigger database lock, blinded data review, statistical analysis, unblinding and disclosure of topline results.

The contract research organization reported 78 events as of May 11, 2026, in the first-quarter update. The second-quarter release did not give a new event count.

Enrollment in the 80-patient Phase 2 trial of SLS009 in newly diagnosed first-line AML reached 28 patients, with dosing continuing and topline data still expected in the fourth quarter of 2026. The study includes patients who become refractory early to azacitidine/venetoclax, identified through transcriptomics, genomics and proteomics models.

The company also reported preclinical indications of SLS009 efficacy in advanced pancreatic ductal adenocarcinoma resistant to RAS inhibitors, with clinical development preparations ongoing at a top-tier academic institution. The first-quarter update did not highlight that pancreatic work.

Research and development expenses were $6.3 million for the quarter ended June 30, 2026, compared with $3.9 million a year earlier. The increase was primarily due to manufacturing costs, clinical and regulatory consulting, and clinical trial expenses in preparation for a potential GPS BLA after the REGAL final analysis.

General and administrative expenses were $4.4 million, versus $3.0 million a year earlier, due to higher professional fees and non-cash stock-based compensation.

The net loss was $9.6 million, or $0.05 a share, compared with a net loss of $6.6 million, or $0.07 a share, in the second quarter of 2025. Weighted-average common shares outstanding, basic and diluted, were 189.2 million.

Interest income was $1.02 million in the three months ended June 30, 2026.

Cash and cash equivalents totaled approximately $138.3 million as of June 30, 2026, up from $107.1 million as of March 31, 2026. The first-quarter release noted an additional $7.5 million in proceeds received in the second quarter to date through warrant exercises.

GPS is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein. The company is also developing SLS009 (tambiciclib), which it described as a differentiated small-molecule CDK9 inhibitor. Data in the release suggested a high response rate in AML patients with unfavorable prognostic factors, including ASXL1 mutation.

For the six months ended June 30, 2026, research and development expenses were $11.4 million and general and administrative expenses were $8.5 million. The net loss for that six-month period was $18.0 million, or $0.10 a share.

The company intends to support clinical development of SLS009 in pancreatic cancer at a top-tier academic institution after the preclinical results.