SELLAS Life Sciences Group, Inc. (SLS), a late-stage clinical biopharmaceutical company, reported financial results for the full year 2025, reflecting a narrower net loss and provided a clinical pipeline update.
For 2025, net loss shrank to $26.86 million, or $0.25 per share, from $30.88 million, or $0.50 per share, in the prior year.
SELLAS investigational candidates currently include Galinpepimut-S (GPS), a cancer immunotherapeutic agent that targets the WT1 protein, which is present in 20 or more cancer types, and SLS009, a highly selective small-molecule inhibitor of cyclin-dependent kinase 9 (CDK9).
SELLAS' cancer programs target diverse indications in haematological cancers and solid tumours, including Acute Myeloid Leukaemia (AML).
GPS is licensed globally from Memorial Sloan Kettering Cancer Centre and SLS009 is licensed from GenFleet Therapeutics (Shanghai), Inc., for uses outside of Greater China.
-GPS or Galinpepimut-S in Acute Myeloid Leukaemia
SELLAS noted that it is advancing toward the final analysis of the pivotal Phase 3 REGAL trial of Galinpepimut-S (GPS) in patients with Acute Myeloid Leukaemia (AML) who have achieved complete remission following second-line salvage therapy.
Currently in the Phase 3 REGAL trial, SELLAS expects to reach the pre-specified 80 events to proceed to database lock completion, statistical analysis, unblinding, and disclosure of topline results.
"If positive, REGAL could position GPS as a first- and best-in-class immunotherapeutic option in this AML population and serve as a significant value-inflexion point for SELLAS," said Angelos Stergiou, President and Chief Executive Officer of SELLAS.
- SLS009 in Acute Myeloid Leukaemia
Phase 2 trial of SLS009 evaluated SLS009 in combination with Azacitidine and Venetoclax for the treatment of patients with r/r AML with myelodysplastic syndrome-related changes after prior VEN-based treatment and reported encouraging results.
Also, for SLS009, following the positive Phase 2 results in r/r AML, SELLAS has now dosed the first patient in the expansion cohort evaluating SLS009 in newly diagnosed, first-line AML patients.
Also, in January 2026, SELLAS entered into a strategic collaboration with IMPACT-AML to expand SLS009 in Europe.
Under the agreement, IMPACT-AML's STREAM clinical network will conduct a study of SLS009 in combination with Azacitidine and Venetoclax in newly diagnosed AML patients.
The enrollment of approximately 40 patients in Europe is anticipated in the second quarter of 2026.
Angelos Stergiou added, "Based upon continued progress in our GPS and SLS009 clinical programs in AML, we believe 2026 is shaping up to be a pivotal year for SELLAS."
-Cash Balance
As of December 31, 2025, SELLAS' cash and cash equivalents totalled approximately $71.8 million, and the firm subsequently received an additional $42.6 million in proceeds from the exercise of previously outstanding warrants in the first quarter of 2026.
SLS has traded between $0.95 and $6.14 in the last year. The stock closed Thursday's trade at $5.20, up 5.05%.
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