atai Life Sciences Achieves Milestone Quarter with Positive BPL-003 Trial Data and Planned Beckley Psytech Merger.

atai Life Sciences reported positive topline data from its Phase 2b trial of BPL-003 for treatment-resistant depression, a single intranasal dose delivering rapid, robust and durable antidepressant effects lasting up to eight weeks. The company plans to merge with Beckley Psytech, creating a combined entity focused on short in-clinic, psychedelic-based mental health therapies. atai also reported $95.9 million in cash and cash equivalents, with an additional $50 million in committed funding secured in July.

atai Life Sciences has announced positive topline data from its Phase 2b trial of BPL-003, an intranasal mebufotenin benzoate for treatment-resistant depression (TRD). The trial demonstrated rapid, robust, and durable antidepressant effects with a single dose, lasting up to eight weeks. The company also plans to merge with Beckley Psytech, aiming to create a global leader in psychedelic-based mental health therapies.

The Phase 2b trial, conducted at 38 sites across six countries, enrolled 193 patients with moderate to severe TRD. Participants were randomly assigned to receive a single dose of 12 mg, 8 mg, or a 0.3 mg comparator. The study met its primary and all key secondary endpoints, showing statistically significant reductions in depressive symptoms as early as one day after dosing and maintaining effects until week 8.

BPL-003 was generally well-tolerated, with 99% of treatment-emergent adverse events being mild or moderate. No drug-related serious adverse events or suicide-related safety signals were reported. The majority of patients were deemed ready for discharge at the 90-minute post-dose assessment.

atai Life Sciences also reported $95.9 million in cash and cash equivalents, with an additional $50 million in committed funding secured in July. The company plans to submit an End-of-Phase 2 meeting request to the U.S. Food and Drug Administration (FDA) in the third quarter of 2025.

References:
[1] https://www.psychiatrictimes.com/view/recent-updates-in-psychopharmacology-insights-in-schizophrenia-adhd-and-treatment-resistant-depression
[2] https://www.marketscreener.com/news/atai-life-sciences-reports-second-quarter-2025-financial-results-and-recent-corporate-updates-ce7c51d9d98cf124