AtaiBeckley Participates in the 64th Annual ACNP Meeting with Two Scientific Poster Presentations and Hot Topic Presentation
Rhea-AI Summary
AtaiBeckley (NASDAQ: ATAI) presented new clinical and preclinical data at the 64th Annual ACNP Meeting (Jan 12–15, 2026) in Nassau, Bahamas. A Phase 2b double-blind study of intranasal BPL-003 (mebufotenin benzoate) showed that a single 8 mg or 12 mg dose produced a significant, rapid, and sustained antidepressant effect versus a 0.3 mg sub-perceptual control at all timepoints, with both active doses reported as well-tolerated. The BPL-003 poster was selected for the Hot Topics Session. A separate preclinical poster on 5-MeO-DMT reported pharmacology, pharmacokinetics, and potential neuroplasticity-relevant effects supporting further investigation. The company said these results support moving toward Phase 3 evaluation for BPL-003.
Positive
- Phase 2b single-dose BPL-003 (8 mg and 12 mg) showed significant, rapid antidepressant effects versus 0.3 mg control
- Both active BPL-003 doses were reported as well-tolerated
- BPL-003 poster was selected for ACNP Hot Topics Session, indicating high scientific recognition
- Preclinical data for 5-MeO-DMT support pharmacology, pharmacokinetics, and neuroplasticity-related mechanisms
Negative
- Results are from a Phase 2b single-dose study and require confirmation in Phase 3 trials
- Preclinical 5-MeO-DMT findings are not clinical efficacy evidence and need clinical validation
News Market Reaction
On the day this news was published, ATAI declined 1.89%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
ATAI slipped 0.27% while peers showed mixed moves (e.g., ATNF up 2.92%, QURE/RAPP/SYRE/VERV modestly down), and no peers appeared in the momentum scanner, indicating stock-specific trading rather than a sector-wide move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Jan 08 | 2026 outlook update | Positive | -0.8% | Outlined positive BPL-003 data, pipeline milestones, and funding into 2029. |
| Dec 30 | Redomiciliation | Positive | +2.8% | Completed move to Delaware with 1:1 share exchange and governance benefits. |
| Dec 23 | Index inclusion | Positive | +0.7% | Added to Nasdaq Biotechnology Index after capital raises and program advances. |
| Dec 11 | Patent grant | Positive | +2.1% | New U.S. patent for EMP-01 with exclusivity to 2043 and Phase 2a plans. |
| Nov 19 | Leadership changes | Neutral | -4.2% | Announced leadership reshuffle and new executives on the board and team. |
Recent news shows mostly positive corporate and clinical catalysts, with three of four positive events followed by gains, but one notable divergence where a constructive 2026 outlook coincided with a slight decline.
Over the last few months, AtaiBeckley reported several strategic and clinical milestones. It was added to the Nasdaq Biotechnology Index on Dec 22, 2025 after raising about $300 million and advancing late-stage programs. A U.S. patent for EMP-01 provides exclusivity through 2043, and the company completed redomiciliation to Delaware with about 99% shareholder approval. A 2026 outlook on Jan 8, 2026 highlighted positive Phase 2b BPL-003 data and funding into 2029. Today’s ACNP presentations build directly on those BPL-003 and 5‑MeO‑DMT developments.
Regulatory & Risk Context
The company has an effective S-3ASR filed on September 29, 2025 for registered securities resale, with at least 3 prospectus supplements (including a 424B7) already used. This framework provides flexibility for registered transactions by existing holders without specified aggregate amount in the summary.
Market Pulse Summary
This announcement highlights new Phase 2b and preclinical data for BPL-003 and 5‑MeO‑DMT, reinforcing AtaiBeckley’s focus on treatment-resistant depression and mood disorders. The single 8 mg and 12 mg intranasal doses showed rapid, sustained effects versus a 0.3 mg control, and the work on neuroplasticity-related mechanisms adds scientific depth. Recent milestones, including index inclusion and patent expansion, frame this as part of an ongoing late-stage pipeline build-out, while the existing S-3ASR underscores continued capital markets flexibility.
Key Terms
treatment-resistant depression medical
phase 2b medical
5-methoxy-n,n-dimethyltryptamine medical
5-meo-dmt medical
pharmacokinetic medical
5-ht receptor agonist medical
neuroplasticity medical
nasal spray medical
AI-generated analysis. Not financial advice.
NEW YORK, Jan. 16, 2026 (GLOBE NEWSWIRE) -- AtaiBeckley Inc. (NASDAQ: ATAI) (“AtaiBeckley” or “Company”), a clinical-stage biotechnology company on a mission to transform patient outcomes by developing rapid-acting, durable and convenient mental health treatments, today announced its participation in the 64th Annual Meeting of the American College of Neuropsychopharmacology (ACNP), which took place on 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 also selected for inclusion in the prestigious Hot Topics Session - a highly competitive forum reserved for the most compelling and impactful new findings across neuropsychopharmacology. 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.
In addition, 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.
Commenting on the Company’s participation at ACNP, Dr Kevin Craig, Chief Medical Officer at AtaiBeckley said, “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 underscores the strength and impact of our clinical findings in treatment-resistant depression. We’re 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 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.
About AtaiBeckley Inc.
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.
For the latest updates and to learn more about the AtaiBeckley mission, visit www.ataibeckley.com or follow the Company on LinkedIn and on X.
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 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.
Contact Information
Investor Contact:
IR@ataibeckley.com
Media Contact:
PR@ataibeckley.com
Note: This announcement has not been sanctioned by the ACNP.
FAQ
What did AtaiBeckley (ATAI) present about BPL-003 at ACNP 2026?
Why is the BPL-003 poster selection as an ACNP Hot Topic important for ATAI?
Does the ACNP data mean BPL-003 is approved for treatment-resistant depression?
What did AtaiBeckley report about 5-MeO-DMT preclinical research at ACNP?
Will AtaiBeckley move BPL-003 into Phase 3 based on the ACNP presentations?
