NEW YORK, NY — January 16, 2026 — Leads & Copy —
AtaiBeckley Inc. (NASDAQ: ATAI), a clinical-stage biotechnology company focused on developing mental health treatments, announced its participation in the 64th Annual Meeting of the American College of Neuropsychopharmacology (ACNP). The meeting took place January 12 – 15, 2026, in Nassau, The Bahamas.
The Company presented new clinical and preclinical data supporting its development of transformative mental health therapies in two poster presentations and a Hot Topic Presentation.
Dr. David Feifel, Professor Emeritus of Psychiatry at the University of California, San Diego and Founder and President of the Kadima Neuropsychiatry Institute, presented efficacy and safety data from AtaiBeckley’s Phase 2b study of BPL-003 (mebufotenin benzoate) nasal spray in patients with treatment-resistant depression (TRD).
Dr. Feifel’s poster, titled ‘Rapid Antidepressant Effect of Intranasal BPL-003 (5-methoxy-N,N-dimethyltryptamine) in Treatment-Resistant Depression: A Phase 2b Double-Blind Study,’ was selected for inclusion in the Hot Topics Session.
The poster showed that a single 8 mg or 12 mg dose of BPL-003 resulted in a significant, rapid, and sustained antidepressant effect compared with a 0.3 mg sub-perceptual dose control at all timepoints in the study, and that both active dose levels were well-tolerated. The findings indicate the potential benefits of intranasal BPL-003 in the treatment of TRD and highlight the need for further investigation in Phase 3 trials.
Dr. Michelle Kokkinou, Senior Scientist, Non-Clinical Development at AtaiBeckley, presented a preclinical poster titled ‘The Pharmacological, Pharmacokinetic and Potential Neuroplasticity-Related Profile of 5-MeO-DMT (mebufotenin), a 5-HT Receptor Agonist for the Treatment of Mood Disorders.’
The study investigated in vitro binding, in vivo pharmacokinetics, efficacy and potential mechanism of action of 5-MeO-DMT preclinically. The findings support effects of 5-MeO-DMT that are potentially relevant to its therapeutic use for the treatment of mood disorders, and highlight therapeutic approaches for targeting neuroplasticity alterations thought to be implicated in individuals with mood disorders.
According to Dr Kevin Craig, Chief Medical Officer at AtaiBeckley, the company is pleased that the Phase 2b BPL-003 results were selected for poster presentation and recognized as a Hot Topic at ACNP. Dr. Craig also stated the company is equally pleased that the preclinical work exploring the pharmacology of 5-MeO-DMT was accepted for presentation. According to Dr. Craig, these presentations showcase the breadth of the company’s science and commitment to creating breakthroughs in mental health.
BPL-003 is a patent-protected, proprietary intranasal formulation of mebufotenin benzoate, administered via a nasal spray device used in a previously approved drug product. BPL-003 is designed to deliver rapid and durable effects from a single dose, with a short psychedelic duration, and is being investigated as a potential therapy for treatment-resistant depression (TRD) and alcohol use disorder (AUD).
BPL-003 has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration and is covered by granted US, UK and European composition-of-matter patents, with multiple further claims pending in various jurisdictions.
AtaiBeckley is a clinical-stage biotechnology company on a mission to transform patient outcomes by developing rapid-acting, durable and convenient mental health treatments. It was formed through the strategic combination of atai Life Sciences N.V. and Beckley Psytech Limited in November 2025.
AtaiBeckley’s pipeline of novel therapies includes BPL-003 (mebufotenin benzoate nasal spray) for treatment-resistant depression (TRD), VLS-01 (DMT buccal film) for TRD and EMP-01 (oral R-MDMA) for social anxiety disorder, which are in Phase 2 clinical development. It is also advancing a drug discovery program to identify novel, non-hallucinogenic 5-HT2AR agonists for opioid use disorder and TRD. These programs aim to create new possibilities in mental health by providing effective, commercially scalable and convenient interventional psychiatry therapies that can integrate seamlessly into healthcare systems.
Investor Contact:
IR@ataibeckley.com
Media Contact:
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Source: AtaiBeckley Inc.
