SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) reported its financial results for the third quarter ended September 30, 2026, and provided an update on its clinical pipeline. The company announced that it expects to release topline primary endpoint results for its Phase 3 REGAL trial of Galinpepimut-S (GPS) in acute myeloid leukemia (AML) this month.
The Phase 3 REGAL trial is evaluating GPS in AML patients who have achieved complete remission following second-line salvage therapy. In October 2026, the company announced that the required pre-specified 80th event had occurred, triggering the database lock and blinded data review procedures. The company stated that the 80th event occurred in October 2026.
In its AML program, SELLAS is also advancing SLS009 (tambiciclib). The company reported that 40 patients have been enrolled in a Phase 2 trial of SLS009 in newly diagnosed AML. Preliminary topline data from this trial is expected in the fourth quarter of 2026. Additionally, data from a completed Phase 2 study of SLS009 in combination with azacitidine and venetoclax for relapsed or refractory AML will be presented at the 68th American Society of Hematology (ASH) Annual Meeting in New Orleans on December 12–15, 2026. The data showed a 54% overall response rate (ORR) in patients with relapsed or refractory monocytic AML and a 57% ORR in patients with TP53-mutated AML, with median overall survival (mOS) of 5.8 months and 8.8 months, respectively.
Regarding financial performance, SELLAS reported research and development expenses of $7.0 million for the third quarter of 2026, compared to $4.2 million in the same period of 2025. General and administrative expenses were $4.3 million for the third quarter of 2026, compared to $2.9 million in the prior year. The company recorded a net loss of $10.1 million for the quarter, or $0.05 per share, compared to a net loss of $6.8 million, or $0.06 per share, in the prior year.
As of September 30, 2026, the company held $134.7 million in cash and cash equivalents, up from $71.8 million at the end of 2025. The company noted that the increase in cash was primarily due to the exercise of warrants and the issuance of common stock during the period.