NEW YORK, March 17, 2026 — AtaiBeckley Inc. (NASDAQ: ATAI) (“AtaiBeckley” or “Company”), a clinical-stage biotechnology company dedicated to transforming patient outcomes through the development of rapid-acting, durable, and convenient mental health treatments, today announced the peer-reviewed publication of results from its ongoing four-part Phase 2a study (NCT05660642) evaluating BPL-003 (mebufotenin benzoate nasal spray) in patients with treatment-resistant depression (TRD). Published in the Journal of Psychopharmacology, the newly reported data stem from Cohort 1 – a 12-week, open-label trial administering a single 10 mg intranasal dose of BPL-003 to 12 patients with moderate-to-severe TRD who were not using concurrent antidepressants. BPL-003 led to a mean reduction of 12.6 points in Montgomery–Åsberg Depression Rating Scale (MADRS) total scores by Day 2 (from a baseline mean of 27.5 to 14.8), with this improvement sustained over 12 weeks, resulting in a mean MADRS score of 14.5 at Day 85. A response rate (≥50% MADRS reduction) of 54.5% was observed from the day after dosing through Day 85, and 63.6% of patients achieved remission (MADRS ≤10) at one or more time points. Mean Snaith-Hamilton Pleasure Scale (SHAPS) scores also improved from 8.4 at baseline to 1.5 at Day 85, indicating the absence of anhedonia. BPL-003 was well tolerated, with no serious adverse events and no treatment discontinuations due to adverse events. Most adverse events were transient and mild-to-moderate in severity.
Following a successful End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) announced in March 2026, the Phase 3 development program for BPL-003 in TRD remains on schedule for initiation in Q2 2026.
“The publication of these findings in the Journal of Psychopharmacology marks a significant scientific milestone. In this first cohort, we observed a rapid 12.6-point mean reduction in MADRS scores by Day 2, which persisted over 12 weeks with a single dose,” said Srinivas Rao, Co-Founder and Chief Executive Officer of AtaiBeckley. “We are proud to be advancing a novel treatment designed to deliver rapid, long-lasting results and integrate smoothly into clinical care. With Phase 3 on track to begin in Q2 2026, these peer-reviewed results strengthen our confidence in BPL-003’s potential to meaningfully address a critical unmet need for patients living with treatment-resistant depression.”
Clinical Development Update
The Phase 2a trial consists of four cohorts. Results from Parts 1, 2, and 3 have been previously announced. The first patient has been dosed in the Part 4 cohort, which is evaluating a two-dose induction regimen (8 mg + 8 mg) of BPL-003 in TRD patients taking specified antidepressants, with initial data expected in Q4 2026.
About BPL-003
BPL-003 is a patent-protected, proprietary intranasal formulation of mebufotenin benzoate, delivered via a nasal spray device used in a previously approved drug product. Designed to provide rapid and durable effects from a single dose with a short psychedelic duration, BPL-003 is being studied 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 additional claims pending in multiple jurisdictions.
About AtaiBeckley Inc.
AtaiBeckley is a clinical-stage biotechnology company committed to transforming patient outcomes through the development of rapid-acting, durable, and convenient mental health treatments. AtaiBeckley’s pipeline of innovative therapies includes BPL-003 (mebufotenin benzoate nasal spray) for TRD, VLS-01 (DMT buccal film) for TRD, and EMP-01 ((R)-MDMA HCI) for social anxiety disorder. BPL-003 is in Phase 3 planning, while VLS-01 and EMP-01 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 drive breakthroughs in mental health through transformative interventional psychiatry therapies that can seamlessly integrate 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 these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these terms. Forward-looking statements include, among others, express or implied statements regarding: our business strategy and plans; expectations for the outcome of regulatory discussions on BPL-003 development; expectations for advancing into Phase 3 studies in adults with TRD and related milestones; expectations for the design of the Phase 3 program; and the potential benefits of BPL-003 for patients with TRD.
Forward-looking statements are not guarantees but involve known and unknown risks and uncertainties that could cause actual results to differ materially from projections, including, without limitation, the key factors described in the “Risk Factors” section of our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”), which may be updated periodically in our quarterly reports and other SEC filings. AtaiBeckley disclaims any obligation to update or revise any forward-looking statements in this press release, except as required by applicable law.
Contact Information:
Investors:
Jason Awe, PhD
VP, Investor Relations
IR@ataibeckley.com
Media:
Charlotte Chorley
Associate Director, Communications
PR@ataibeckley.com