AtaiBeckley presented pivotal results from its randomized, double-blind Phase 2b study of BPL-003 (mebufotenin benzoate) nasal spray in ninety adults with treatment-resistant depression at the ACNP Annual Meeting in Nassau, The Bahamas. Single intranasal doses of 8 mg and 12 mg produced statistically significant reductions in Montgomery–Åsberg Depression Rating Scale (MADRS) total scores versus a 0.3 mg sub-perceptual control at all post-dose timepoints through Day 28 (p<0.01). Both active arms demonstrated rapid onset of antidepressant effect within four hours and sustained improvement reaching mean MADRS score drops of 15 points by Day 7. Tolerability was favorable, with most adverse events rated mild or moderate and resolving within two hours, supporting advancement to Phase 3 trials.

In a second poster, AtaiBeckley’s non-clinical team detailed in vitro and in vivo pharmacology of 5-MeO-DMT. Binding assays showed high affinity agonism at 5-HT₁A and 5-HT₂A receptors (Ki values of 12 nM and 9 nM, respectively). Rodent models exhibited enhanced synaptic marker expression and increased dendritic spine density in the prefrontal cortex 24 hours post-administration. Pharmacokinetic analysis in rats revealed a plasma half-life of 45 minutes and brain exposure correlating with neuroplasticity markers. These data underscore 5-MeO-DMT’s potential to induce rapid neuroadaptive changes relevant to mood disorder treatment.

Recognition of the BPL-003 poster in the Hot Topics Session—the ACNP’s most selective forum—validates AtaiBeckley’s clinical approach and strengthens the case for Breakthrough Therapy designation by the U.S. Food and Drug Administration. The company plans to initiate two global Phase 3 studies in Q3 2026, enrolling up to 600 patients across North America and Europe, with primary endpoints of change in MADRS at Day 7 and remission rates at Day 28. Parallel non-hallucinogenic 5-HT₂A agonist programs will enter lead optimization in mid-2026, leveraging insights from the 5-MeO-DMT pharmacology profile to expand therapeutic options for opioid use disorder and TRD.

Formed through the November 2025 merger of atai Life Sciences N.V. and Beckley Psytech Limited, AtaiBeckley is a clinical-stage biotechnology company dedicated to developing rapid-acting, durable, and convenient mental health therapies. Its pipeline includes BPL-003 for TRD and alcohol use disorder, VLS-01 (DMT buccal film) for TRD, and EMP-01 (oral R-MDMA) for social anxiety disorder, all in Phase 2 development. The company is also advancing discovery programs targeting novel, non-hallucinogenic 5-HT₂A agonists for psychiatric and substance use disorders, with the goal of integrating new interventional psychiatry treatments into standard healthcare practice.