BPL-003 Demonstrates Rapid and Durable Antidepressant Effects in Treatment-Resistant Depression; Phase 2a Data Published in Journal of Psychopharmacology; Phase 3 Program on Track for Q2 2026 Initiation

AtaiBeckley (NASDAQ: ATAI) reported peer-reviewed Phase 2a Cohort 1 results for BPL-003 in treatment-resistant depression (TRD).

Rhea-AI Summary

AtaiBeckley (NASDAQ: ATAI) reported peer-reviewed Phase 2a Cohort 1 results for BPL-003 in treatment-resistant depression (TRD). A single 10 mg intranasal dose produced a mean MADRS reduction of 12.6 points by Day 2 (27.5 to 14.8), sustained to Day 85 (14.5).

Response rate ≥50% was 54.5% through Day 85; 63.6% achieved remission at one or more timepoints. SHAPS improved from 8.4 to 1.5. No serious adverse events or withdrawals were reported. Phase 3 remains on track to initiate in Q2 2026 after a successful EOP2 meeting.

Positive

• Mean MADRS reduction of 12.6 points by Day 2
• Sustained mean MADRS score of 14.5 at Day 85 on single dose
• 54.5% response rate (≥50% MADRS reduction) through Day 85
• 63.6% remission at one or more timepoints
• SHAPS improved from 8.4 to 1.5, indicating reduced anhedonia
• No serious adverse events and no withdrawals due to adverse events

Negative

• Small cohort size: 12 patients, limiting statistical power
• Open-label design in Cohort 1 may introduce bias in efficacy estimates
• Cohort 1 excluded patients on concomitant antidepressants, limiting generalizability

Market Context

This announcement highlights peer-reviewed Phase 2a data for BPL-003 showing rapid and durable antid...

Analysis

This announcement highlights peer-reviewed Phase 2a data for BPL-003 showing rapid and durable antidepressant effects and improved SHAPS scores with a benign safety profile. It reinforces the program’s path toward Phase 3 initiation in Q2 2026, following a successful FDA End-of-Phase 2 meeting. Investors may track upcoming Part 4 data expected in Q4 2026, progress on the broader psychiatry pipeline, and any further use of the effective S-3ASR shelf.

Key Figures

BPL-003 dose: 10 mg intranasal Cohort size: 12 patients MADRS reduction: 12.6 points +5 more

BPL-003 dose

10 mg intranasal

Single dose in Phase 2a Cohort 1 TRD patients

Cohort size

12 patients

Moderate-to-severe TRD, no concomitant antidepressants

MADRS reduction

12.6 points

Mean decrease by Day 2 from baseline in Cohort 1

Baseline MADRS

27.5

Mean score at baseline in Cohort 1

Day 85 MADRS

14.5

Mean score at Week 12 after single dose

Response rate

54.5%

≥50% MADRS reduction from day after dosing to Day 85

Remission rate

63.6%

Patients achieving MADRS ≤10 at ≥1 timepoint

SHAPS change

8.4 to 1.5

Mean Snaith-Hamilton Pleasure Scale from baseline to Day 85

Previous Clinical trial Reports

5 past events · Latest: Mar 10

Same Type 5 events

1. Mar 10

   Phase 3 planning

   24h Move

   +6.4%

   Outlined BPL-003 Phase 3 timing, Breakthrough status, and broader pipeline milestones.

2. Mar 03

   FDA EOP2 meeting

   24h Move

   +0.3%

   Reported successful End-of-Phase 2 FDA meeting and dual pivotal Phase 3 support.

3. Feb 26

   EMP-01 Phase 2a

   24h Move

   -14.1%

   Shared positive Phase 2a topline EMP-01 data in Social Anxiety Disorder with safety met.

4. Nov 10

   BPL-003 Phase 2b OLE

   24h Move

   -0.2%

   Announced positive Phase 2b OLE BPL-003 results showing durable second-dose effects.

5. Jul 25

   Inidascamine miss

   24h Move

   -6.7%

   Reported Phase 2b inidascamine trial did not meet primary endpoint in CIAS.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

treatment-resistant depression (TRD), Phase 2a, Montgomery–Åsberg Depression Rating Scale (MADRS), Snaith-Hamilton Pleasure Scale (SHAPS), +4 more

8 terms

treatment-resistant depression (TRD) medical

"evaluating BPL-003 (mebufotenin benzoate nasal spray) in patients with treatment-resistant depression (TRD)."

Treatment-resistant depression (TRD) is a form of major depression that does not improve after trying two or more standard therapies such as common antidepressants or talk therapy; think of it as a lock that doesn’t open with the usual keys. It matters to investors because patients with TRD represent a large, unmet medical need that drives demand for new drugs and devices, but developing effective treatments often involves longer, riskier and more expensive clinical testing and regulatory review — which can mean bigger potential rewards and bigger risks.

Phase 2a medical

"ongoing four-part Phase 2a study (NCT05660642) evaluating BPL-003"

Phase 2a is an early stage in testing a new medical treatment or drug, where the main goal is to assess its safety and find the right dosage. For investors, this stage indicates whether the treatment shows initial promise before moving on to larger, more definitive studies; progress here can influence expectations for future development and potential success.

Montgomery–Åsberg Depression Rating Scale (MADRS) medical

"produced a mean Montgomery–Åsberg Depression Rating Scale (MADRS) total score reduction"

The Montgomery–Åsberg Depression Rating Scale (MADRS) is a clinician‑administered questionnaire that scores the severity of depressive symptoms across several areas such as mood, sleep, appetite and concentration. Investors monitor MADRS changes in clinical trial results because it offers a consistent, numerical readout of whether a treatment is improving depression; larger, sustained score improvements can increase the odds of regulatory approval, market uptake and revenue forecasts.

Snaith-Hamilton Pleasure Scale (SHAPS) medical

"Mean Snaith-Hamilton Pleasure Scale (SHAPS) scores also improved from 8.4"

A short patient questionnaire that measures anhedonia — the reduced ability to feel pleasure — by asking how much enjoyment people get from everyday activities, similar to a quick customer-satisfaction score for mood. Investors watch it because regulators and drug developers use changes on this scale as a clinical-trial endpoint to show whether a therapy improves core symptoms, which can affect approval chances, market value and commercial prospects.

anhedonia medical

"to 1.5 at Day 85, indicating an absence of anhedonia."

Anhedonia is the reduced ability to feel pleasure or interest in things that used to be enjoyable, like hobbies, socializing, or eating; think of it as a dimmer switch turning down the joy in everyday activities. For investors, it matters because anhedonia is a common symptom targeted by drugs, therapies, and diagnostics, so its prevalence and how well treatments address it can affect clinical trial outcomes, regulatory approval prospects, market demand, and a healthcare company's valuation.

End-of-Phase 2 (EOP2) meeting regulatory

"Following a successful End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration"

An end-of-phase 2 (EoP2) meeting is a formal discussion between a drug developer and regulators to review mid-stage clinical results and agree on the design, size and success measures of the pivotal Phase 3 trials needed for approval. For investors, the meeting is like a road-test report with a traffic plan: a favorable outcome reduces uncertainty about whether the program can reach approval, shortens timelines and clarifies likely costs and risks.

Phase 3 program medical

"the Phase 3 program for BPL-003 in TRD remains on track for initiation in Q2 2026."

A phase 3 program is the final, large-scale testing of a drug or therapy in many patients to confirm it works, to track side effects, and to compare it with existing treatments before regulators decide on approval. For investors, the outcome of a phase 3 program is crucial because positive results greatly increase the chance of market authorization and future sales, while negative results can halt a product’s commercial prospects—think of it as a full-scale field test before launch.

NCT05660642 technical

"ongoing four-part Phase 2a study (NCT05660642) evaluating BPL-003"

An NCT number is the unique identifier assigned to a clinical trial when it is registered on ClinicalTrials.gov; think of it like a serial number that points to the trial’s public file. Investors use this identifier to look up a trial’s purpose, design, enrollment, locations and status so they can gauge scientific progress, timing for results or regulatory decisions, and the potential impact on a company’s value.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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NEW YORK, March 17, 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 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 come from Cohort 1 – a 12 week, open-label trial of a single 10 mg intranasal dose of BPL-003 in 12 patients with moderate-to-severe TRD who were not taking concomitant antidepressants. BPL-003 produced a mean Montgomery–Åsberg Depression Rating Scale (MADRS) total score reduction of 12.6 points by Day 2 (from a baseline mean of 27.5 to 14.8), which was sustained over 12 weeks to 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 timepoints. Mean Snaith-Hamilton Pleasure Scale (SHAPS) scores also improved from 8.4 at baseline to 1.5 at Day 85, indicating an absence of anhedonia. BPL-003 was well tolerated with no serious adverse events and no treatment withdrawals 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 program for BPL-003 in TRD remains on track for initiation in Q2 2026.

“The publication of these findings in the Journal of Psychopharmacology is an important scientific milestone. In this first cohort, we saw a rapid 12.6-point mean reduction in MADRS scores by Day 2, which was sustained through 12 weeks on 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, durable results and integrate conveniently into clinical care. With Phase 3 on track to initiate in Q2 2026, these peer-reviewed results reinforce 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 comprises four cohorts. Results from Parts 1, 2 and 3 have been previously announced. The first patient has been dosed in the Part 4 cohort, evaluating a two-dose induction regimen (8 mg + 8 mg) of BPL-003 in TRD patients receiving defined antidepressants, with initial data expected in Q4 2026.

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. 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 ((R)-MDMA HCI) for social anxiety disorder. BPL-003 is in Phase 3 planning, 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 create breakthroughs in mental health through transformative 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; expectations regarding the outcome of regulatory discussions regarding the development of BPL 003; expectations regarding the advancement into Phase 3 studies in adults with TRD and related milestones; expectations regarding the design of the Phase 3 program; and the potential benefits of BPL-003 for patients with TRD.

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 our quarterly reports and 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:
Investors:
Jason Awe, PhD
VP, Investor Relations
IR@ataibeckley.com

Media:
Charlotte Chorley
Associate Director, Communications
PR@ataibeckley.com

FAQ

What were the key efficacy results for ATAI's BPL-003 in Phase 2a Cohort 1?

BPL-003 produced a mean MADRS reduction of 12.6 points by Day 2 and sustained to Day 85. According to AtaiBeckley, cohort mean MADRS fell from 27.5 to 14.8 by Day 2 and was 14.5 at Day 85 in 12 patients.

How many patients showed response or remission in the ATAI BPL-003 Phase 2a Cohort 1?

A 54.5% response rate (≥50% MADRS reduction) was observed through Day 85 and 63.6% achieved remission. According to AtaiBeckley, these rates were recorded across the 12-patient open-label Cohort 1.

What safety findings did AtaiBeckley report for BPL-003 in the Phase 2a Cohort 1 study?

BPL-003 was well tolerated with no serious adverse events and no discontinuations for adverse events. According to AtaiBeckley, most adverse events were transient and mild-to-moderate in severity in the 12-patient cohort.

When will ATAI begin the Phase 3 program for BPL-003 in TRD?

Phase 3 for BPL-003 is on track to initiate in Q2 2026 following a successful EOP2 meeting. According to AtaiBeckley, the company announced the Phase 3 start timing after FDA End-of-Phase 2 discussion in March 2026.

What limitations should investors note about the Phase 2a Cohort 1 results for ATAI's BPL-003?

Cohort 1 included only 12 patients and used an open-label design, limiting statistical power and generalizability. According to AtaiBeckley, Cohort 1 also excluded patients on concomitant antidepressants.

What is the next clinical milestone for ATAI's BPL-003 after the Phase 2a publication?

The immediate next milestone is Phase 3 initiation in Q2 2026 and initial Part 4 data expected in Q4 2026. According to AtaiBeckley, Part 4 will evaluate a two-dose induction regimen in patients on defined antidepressants.