NEW YORK, Jan. 16, 2026 — AtaiBeckley Inc. (NASDAQ: ATAI) (“AtaiBeckley” or “Company”), a clinical-stage biotechnology company dedicated to improving patient outcomes through the development of rapid-acting, long-lasting, and convenient mental health treatments, announced its participation in the 64th Annual Meeting of the American College of Neuropsychopharmacology (ACNP). The meeting took place from January 12-15, 2026, in Nassau, The Bahamas. The Company presented new clinical and preclinical data supporting its development of transformative mental health therapies through 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 also selected for the prestigious Hot Topics Session. This highly competitive forum is reserved for the most compelling and impactful new findings in neuropsychopharmacology. The poster demonstrated that a single 8 mg or 12 mg dose of BPL-003 resulted in a significant, rapid, and sustained antidepressant effect compared to a 0.3 mg sub-perceptual dose control at all study timepoints. Both active dose levels were well-tolerated. These findings suggest the potential benefits of intranasal BPL-003 in treating TRD and underscore the need for further investigation in Phase 3 trials.
Additionally, 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.’ This study examined the preclinical in vitro binding, in vivo pharmacokinetics, efficacy, and potential mechanism of action of 5-MeO-DMT. The findings support effects of 5-MeO-DMT that may be relevant to its therapeutic use for mood disorders and highlight therapeutic strategies for targeting neuroplasticity alterations believed to be implicated in individuals with mood disorders.
Commenting on the Company’s participation at ACNP, Dr. Kevin Craig, Chief Medical Officer at AtaiBeckley, stated, “We are delighted that our Phase 2b BPL-003 results were not only selected for poster presentation but also recognized as a Hot Topic, one of the most competitive and prestigious categories at ACNP. This distinction highlights the strength and impact of our clinical findings in treatment-resistant depression. We are equally pleased that our preclinical work exploring the pharmacology of 5-MeO-DMT was accepted for presentation. Together, these presentations showcase the breadth of our science and our commitment to creating breakthroughs in mental health.”
About BPL-003
BPL-003 is a proprietary, patent-protected intranasal formulation of mebufotenin benzoate, administered via a nasal spray device previously used in an approved drug product. BPL-003 is designed to provide rapid and durable effects from a single dose, with a short psychedelic duration. It is being investigated as a potential therapy for treatment-resistant depression (TRD) and alcohol use disorder (AUD). BPL-003 has received Breakthrough Therapy designation from the U.S. Food and Drug Administration and is covered by granted U.S., U.K., and European composition-of-matter patents, with multiple additional claims pending in various jurisdictions.
About AtaiBeckley Inc.
AtaiBeckley is a clinical-stage biotechnology company focused on transforming patient outcomes by developing rapid-acting, durable, and convenient mental health treatments. It was established 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, all of which are in Phase 2 clinical development. The company 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 offering effective, commercially scalable, and convenient interventional psychiatry therapies that can be seamlessly integrated into healthcare systems.
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Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. We intend for such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “anticipate,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things: our business strategy and plans; the potential, success, and timing of development and progress of trials and related milestones of our product candidates such as BPL-003; expectations regarding our intellectual property portfolio; and the plans and objectives of management for future operations, research and development, and capital expenditures.
Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors described in the section titled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”), as such factors may be updated from time to time in AtaiBeckley’s other filings with the SEC. AtaiBeckley disclaims any obligation to update or revise any forward-looking statements contained in this press release, other than to the extent required by applicable law.
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Note: This announcement has not been sanctioned by the ACNP.
