Sellas Reports $10.1 Million Q3 Net Loss Ahead of GPS Readout
Third-quarter 2026 R&D expenses rose to $7.0 million; cash and cash equivalents were $134.7 million as of September 30 as the company prepared a potential GPS biologics license application.
SELLAS Life Sciences Group, Inc. (SLS), a late-stage clinical biopharmaceutical company developing cancer therapies, reported research and development expenses of $7.0 million and a net loss of $10.1 million, or $0.05 a share, for the third quarter ended September 30, 2026. The company said the pre-specified 80th event in its Phase 3 REGAL trial of galinpepimut-S (GPS) in acute myeloid leukemia occurred in October 2026, triggering database lock and blinded review ahead of a topline primary-endpoint readout the company expects this month.
That milestone closed a sequence that had still been waiting on the 80th event when the company reported second-quarter results. President and Chief Executive Officer Angelos Stergiou said the company is focused on completing the final analysis and that, if successful, GPS could be a transformative new immunotherapy for AML patients in second complete remission.
Research and development expenses were $7.0 million for the quarter ended September 30, 2026, compared with $4.2 million in the third quarter of 2025. The company said the nine-month increase in research and development expenses, to $18.4 million from $11.3 million a year earlier, was primarily due to manufacturing costs, clinical and regulatory consulting, and clinical trial expenses in preparation for a potential Biologics License Application for GPS following the final analysis of REGAL.
General and administrative expenses were $4.3 million in the third quarter. The net loss was $10.1 million, or $0.05 a share, versus a $9.6 million, or $0.05 a share, net loss in the second quarter.
Cash and cash equivalents were $134.7 million as of September 30, 2026, down from $138.3 million as of June 30. Stergiou said the company is well positioned to further advance its programs.
Enrollment in the 80-patient Phase 2 trial of tambiciclib (SLS009) in newly diagnosed first-line AML reached 40 patients, up from 28 reported at the end of the second quarter. Enrollment and dosing continue, and preliminary topline data remain expected in the fourth quarter of 2026.
The company also said it will present completed Phase 2 data of SLS009 in combination with azacitidine and venetoclax in relapsed or refractory AML at the 68th American Society of Hematology meeting in December 2026. Patients with relapsed/refractory monocytic AML achieved a 54% overall response rate and a median overall survival of 5.8 months; patients with TP53-mutated AML achieved a 57% overall response rate and a median overall survival of 8.8 months, which the company said compared favorably to historical outcomes of about 2.5 months in those adverse-risk settings.
In September, SELLAS presented preclinical data on SLS009 in patient-derived organoid models of pancreatic ductal adenocarcinoma, including a model resistant to the RAS inhibitor daraxonrasib and a combination with the BET inhibitor ZEN3694, at an AACR pancreatic-cancer conference. The company said the findings support further investigation of CDK9 inhibition to enhance RAS-directed therapy and potentially address MYC-associated resistance, and that it is continuing preparations for clinical development in that indication.
For the nine months ended September 30, 2026, research and development expenses were $18.4 million and general and administrative expenses were $12.8 million. The net loss for the nine months was $28.1 million, or $0.15 a share.
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