Atai Beckley (ATAI) Company Report

AtaiBeckley outlined its 2026 pipeline strategy in January, with its lead candidate BPL-003 for treatment-resistant depression having met its primary and all key secondary endpoints in Phase 2b. The company expects Phase 3 guidance in Q1 2026 and trial initiation by mid-year.
The company's financial resources are projected to support operations into 2029.
Other pipeline assets include VLS-01, a DMT buccal film, with Phase 2 data expected in the second half of 2026, and EMP-01, an oral R-MDMA compound, with Phase 2a results anticipated this quarter.
AtaiBeckley was added to the NASDAQ Biotechnology Index in December following its formation through the merger of atai Life Sciences and Beckley Psytech, and a new patent extends exclusivity for its R-MDMA compound through 2043.

13 hours ago

Press Release

Atai Life Sciences Announces Positive Phase 2A Top-Line Data for EMP-01 in Social Anxiety Disorder

ATAI

New Projects/Investments

Atai Life Sciences reported positive top-line results from its exploratory Phase 2A trial of EMP-01, an oral R-MDMA candidate, for social anxiety disorder (SAD).
The study, which included 70 patients, demonstrated a well-tolerated safety profile with only mild or moderate adverse events and no severe or serious adverse events.
Key efficacy findings at day 43 included a least squared mean treatment difference of 11.85 points on the LSAS total score and a 45% responder rate (CGI-I score of two or less) in the EMP-01 group, compared to 14% in the placebo group.
The number needed to treat (NNT) for EMP-01 was less than three, indicating a clinically meaningful benefit comparable to or better than existing pharmacotherapies for SAD.

1 day ago

Transcript

Beckley Psytech Announces Positive Phase 2A Top-Line Results for EMP-01 in Social Anxiety Disorder

ATAI

New Projects/Investments

Beckley Psytech announced positive top-line results from its exploratory phase 2A trial of EMP-01 for social anxiety disorder (SAD).
At day 43, EMP-01 demonstrated a least squared mean treatment difference of 11.85 points on the LSAS total score and a standardized effect size of 0.45 compared to placebo.
The trial also showed a high responder rate, with nearly 50% of patients in the EMP-01 group achieving a CGI-I score of 2 or less, versus 14% in the placebo group, resulting in a favorable Number Needed to Treat (NNT) of less than 3.
These results support further development of EMP-01 in SAD, with future plans including larger studies and exploration of optimal dosing frequency.

1 day ago

Transcript

Atai Beckley Reports Positive Phase IIa EMP-01 Data for Social Anxiety Disorder

ATAI

New Projects/Investments

Beckley Psytech, an Atai Life Sciences company, reported positive top-line results from its exploratory phase IIa trial of EMP-01 in social anxiety disorder (SAD).
The study, which included 70 patients, demonstrated a well-tolerated safety profile with no severe or serious adverse events.
Key efficacy signals showed a least squared mean treatment difference of 11.85 points on the LSAS between EMP-01 and placebo, and a number needed to treat (NNT) of less than three for responders (CGI-I score of two or less).
These results are considered clinically meaningful and support the further development of EMP-01 for SAD.

1 day ago

Transcript

AtaiBeckley announces positive Phase 2a top-line results for EMP-01 in Social Anxiety Disorder

ATAI

AtaiBeckley announced positive top-line results from its exploratory Phase 2a study of EMP-01 (R-MDMA) for Social Anxiety Disorder (SAD) on February 26, 2026.
The study demonstrated a favorable and manageable safety and tolerability profile, with no severe or serious treatment-emergent adverse events (TEAEs) reported, and all TEAEs being mild to moderate. Drug-related TEAEs were consistent with expected psychedelic effects and were transient.
EMP-01 showed clinically meaningful improvement in efficacy, with a Least Squares Mean Treatment Difference of -11.85 (p-value 0.036) on the Liebowitz Social Anxiety Scale (LSAS) total score compared to placebo.
Further efficacy analysis indicated that 48.6% of EMP-01 patients were responders (CGI-I = 1 or 2) compared to 14.7% for placebo, resulting in a Number Needed to Treat (NNT) of 2.95.
Benchmarking data suggests EMP-01's clinical activity, including its effect size and NNT, is comparable to or potentially superior to currently approved SSRIs and SNRIs for SAD.

1 day ago

Presentation

AtaiBeckley Outlines Clinical Milestones and Merger Details

ATAI

M&A

New Projects/Investments

Guidance Update

AtaiBeckley (formerly Atai) recently completed a merger with Beckley Psytech and is focused on developing short-duration psychedelic products, similar to Spravato.
For its lead asset, BPL-003, the company expects to provide guidance on end-of-phase II meeting results in Q1 2026 and plans to initiate phase III trials in Q2 2026.
Phase II-B data for BPL-003 in treatment-resistant depression demonstrated 65-70% remission rates at week 16, with no apparent impact on efficacy or durability compared to longer-duration psychedelics, and was well tolerated.
Upcoming data readouts include EMP-01 (phase II-A in social anxiety disorder) in Q1 2026 and VLS-01 (phase II-B in treatment-resistant depression) in 2nd half 2026.

Nov 20, 2025, 11:30 AM

Transcript

ATAI Discusses Clinical Pipeline Milestones and Beckley Psytech Merger

ATAI

M&A

New Projects/Investments

Guidance Update

ATAI completed a merger with Beckley Psytech, now operating as AtaiBeckley, to advance short-duration psychedelic products.
Key upcoming clinical milestones include guidance on BPL-003 end-of-phase 2 meeting results in Q1 2026, initiation of BPL-003 Phase 3 trials in Q2 2026, top-line results for EMP-01 Phase 2a in social anxiety disorder in Q1 2026, and VLS-01 Phase 2b results in treatment-resistant depression in the second half of 2026.
The lead asset, BPL-003, demonstrated 65-70% remission rates at week 16 in its Phase 2b trial for treatment-resistant depression, with a well-tolerated safety profile and an estimated 4-6 doses per year in the real world.
ATAI holds issued patents for BPL-003, covering the salt and transmucosal delivery.

Nov 20, 2025, 11:30 AM

Transcript

AtaiBeckley Details Psychedelic Pipeline Progress and Upcoming Milestones

ATAI

M&A

New Projects/Investments

Guidance Update

AtaiBeckley, formed by a recent merger with Beckley Psytech, is advancing a pipeline of short-duration psychedelic treatments, including its lead asset BPL-003 (5-MeO-DMT) for treatment-resistant depression.
BPL-003 demonstrated 65-70% remission rates at week 16 in Phase 2b trials. Guidance on the results of an end-of-phase 2 meeting request is expected in Q1 2026, with Phase 3 trials planned to initiate in Q2 2026.
Upcoming clinical milestones include top-line results for EMP-01 (R-MDMA) in social anxiety disorder in Q2 2026 and VLS-01 (DMT compound) in treatment-resistant depression in H2 2026.
The company holds issued patents for BPL-003, covering the salt and transmucosal delivery.

Nov 20, 2025, 11:30 AM

Transcript

Atai Beckley N.V. Reports Q3 2025 Financial Results and BPL-003 Breakthrough Therapy Designation

ATAI

Earnings

M&A

Guidance Update

Atai Beckley N.V. reported a net loss of $61.1 million for the third quarter of 2025, compared to $26.3 million for the same period in 2024. Research and development expenses were $14.7 million, and general and administrative expenses were $14.5 million for Q3 2025.
As of September 30, 2025, the company had $114.6 million in cash, cash equivalents, and short-term securities. Including proceeds from an approximate $150 million public offering closed in October, the company expects its liquid assets to fund operations into 2029.
The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for BPL-003 (mebufotenin benzoate nasal spray) for treatment-resistant depression (TRD). An End-of-Phase 2 meeting with the FDA for BPL-003 is scheduled, with guidance on the Phase 3 clinical program anticipated in the first quarter of 2026.
The company also reported positive topline data from the Phase 2b open-label extension study of BPL-003 and completed enrollment in the exploratory Phase 2a trial of EMP-01 for social anxiety disorder. Additionally, AtaiBeckley was awarded a grant by the National Institute on Drug Abuse (NIDA) worth up to $11.4 million for the development of novel 5-HT2A/2C receptor agonists for opioid use disorder.

Nov 12, 2025, 12:19 PM

8-K

ATAI Presents Positive BPL-003 Phase IIb Open-Label Extension Study Data and Outlines Phase III Plans

ATAI

New Projects/Investments

Guidance Update

ATAI announced positive results from the BPL-003 Phase IIb open-label extension study for Treatment Resistant Depression (TRD), demonstrating a 63% response rate and 48% remission rate in subjects who received an 8mg or 12mg dose in the core study, following a second dose.
The drug was well tolerated, with the majority of treatment-emergent adverse events classified as mild or moderate and transient. A single serious drug-related adverse event occurred, which resolved the next day.
The 8mg dose of BPL-003 has been selected for future Phase III studies due to its favorable safety profile and similar efficacy compared to the 12mg dose. After a second dose, the 8mg arm achieved an 81% responder rate and 67% remission rate at day 57.
BPL-003 was granted Breakthrough Therapy Designation by the US FDA for adults with TRD.
ATAI anticipates receiving feedback from the FDA on the end-of-Phase II meeting in the first quarter of next year (2026) and plans to initiate Phase III studies in the second quarter of next year (2026).