Seelos Therapeutics' stock slides 58% after trial of treatment for suicidal ideation has too few patients to meet endpoint

Seelos Therapeutics Inc.'s stock (SEEL) tumbled 58% in premarket trade Wednesday, after the company reported promising results from a trial of a treatment for Acute Suicidal Ideation and Behavior (ASIB) in adults with Major Depressive Disorder (MDD) but said a too-small sample size means the study did not meet its primary endpoint. Seelos enrolled 147 patients in the Phase 2 trial of SLS-002, intranasal racemic ketamine, below its target for 220 patients, which it blamed on financial constraints. The data from the 147 subjects were evaluated using the protocol-endpoint based on a depression rating scale and showed early and persistent reductions in symptoms of depression. "However, assuming the same treatment difference and standard deviation, analyses showed that the study would have achieved statistical significance for the primary endpoint, had the study reached full enrollment (220 patients)," the company said. Chief Medical Officer Tim Whitaker said the company believes SLS-002 can address a huge unmet need and is looking forward to talks with the Food and Drug Administration. The stock is up 47% in the year to date, while the S&P 500 has gained 15.7%.

-Ciara Linnane

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09-20-23 0800ET

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