SELLAS Life Sciences posts $10.1M Q3 loss as pivotal leukemia trial results approach
The biotech company expects to report Phase 3 REGAL trial results in the fourth quarter after reaching its final analysis milestone.
SELLAS Life Sciences recorded a reported third quarter loss of $10.1 million as investors await pivotal clinical trial results for its experimental acute myeloid leukemia treatment.
The New York based biotechnology company is developing galinpepimut S, also known as GPS, a cancer immunotherapy being evaluated in its Phase 3 REGAL trial.
On October 28, SELLAS announced that the study had reached its prespecified 80th event, triggering the final analysis of its primary endpoint measuring overall survival.
The company said it would proceed with database lock, unblinding and statistical analysis before releasing preliminary results during the fourth quarter of 2026.
SELLAS is also developing SLS009, an experimental CDK9 inhibitor being evaluated in combination with existing treatments for acute myeloid leukemia.
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Earlier this month, the company announced Phase 2 findings showing response rates of 54% among patients with monocytic AML and 57% among those with TP53 mutations at its selected dose.
Median overall survival reached 5.8 months and 8.8 months, respectively, in the two patient subgroups. The company plans to present the findings at the American Society of Hematology annual meeting in December.
SELLAS expects additional topline results from its ongoing Phase 2 trial of SLS009 in newly diagnosed leukemia patients during the fourth quarter.
The company previously reported $138.3 million in cash and cash equivalents as of June 30, providing funding for its clinical development programs.
Disclosure: This article was edited by Estefano Gomez. For more information on how we create and review content, see our Editorial Policy.
