Atai Beckley (ATAI) Company Report

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).

Nov 10, 2025, 1:00 PM

Transcript

Atai Beckley N.V. Files Prospectus Supplement for Share Resale

ATAI

M&A

Atai Beckley N.V. (formerly ATAI Life Sciences N.V. ) filed a prospectus supplement on November 5, 2025, covering the resale of up to 5,316,238 common shares.
These common shares have a €0.10 par value per share.
The resale is intended to satisfy registration rights granted to selling securityholders in connection with the Company's acquisition of the remaining issued share capital of Beckley Psytech Limited.

Nov 5, 2025, 1:36 PM

8-K

AtaiBeckley N.V. completes strategic combination

ATAI

M&A

New Projects/Investments

Board Change

ATAI Life Sciences N.V. and Beckley Psytech Limited successfully completed their strategic combination on November 5, 2025, forming AtaiBeckley N.V., a clinical-stage biopharmaceutical company focused on mental health therapies.
The combined entity's pipeline features BPL-003 (mebufotenin benzoate nasal spray), a Phase 3-ready asset for treatment-resistant depression (TRD) that has received FDA Breakthrough Therapy designation, alongside Phase 2 assets VLS-01 and EMP-01.
ATAI Life Sciences' shareholders approved the combination and corporate redomiciliation on November 4, 2025, with approximately 98% of votes cast in favor.
AtaiBeckley anticipates its cash, cash equivalents, short-term investments, and other liquid assets will fund operations into 2029, covering the period through anticipated topline data from the first Phase 3 trial of BPL-003.

Nov 5, 2025, 12:47 PM

8-K

ATAI Life Sciences Completes Public Offering and Underwriters' Option Exercise

ATAI

New Projects/Investments

ATAI Life Sciences N.V. announced the closing of its public offering on October 20, 2025, which included the full exercise of the underwriters' option to purchase additional common shares.
The offering of 27,283,750 common shares at a price of $5.48 per share generated approximately $149.5 million in aggregate gross proceeds.
The company anticipates that these net proceeds, combined with existing liquid assets, will be sufficient to fund operations into 2029.
These funds are primarily allocated to advance clinical development, including the Phase 3 clinical program for BPL-003, and completing Phase 2 trials for VLS-01 and EMP-01.

Oct 21, 2025, 1:30 PM

8-K

ATAI Life Sciences and Beckley Psytech Announce FDA Breakthrough Therapy Designation for BPL-003

ATAI

New Projects/Investments

M&A

ATAI Life Sciences and Beckley Psytech announced on October 16, 2025, that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation (BTD) to BPL-003 (mebufotenin benzoate) nasal spray for adult patients with treatment-resistant depression (TRD).
The BTD expedites development for serious conditions and follows positive topline results from Beckley Psytech's Phase 2b study, which showed rapid and durable antidepressant effects from a single dose of BPL-003.
The Phase 3 clinical program for BPL-003 is anticipated to initiate in the second quarter of 2026, subject to alignment with the FDA.

Oct 16, 2025, 8:52 PM

8-K

ATAI Life Sciences and Beckley Psytech Receive FDA Breakthrough Therapy Designation for BPL-003

ATAI

New Projects/Investments

M&A

ATAI Life Sciences and Beckley Psytech announced that the U.S. FDA granted Breakthrough Therapy designation (BTD) to BPL-003 (mebufotenin benzoate) nasal spray for adult patients with treatment-resistant depression (TRD).
The BTD was granted following positive topline results from Beckley Psytech’s Phase 2b study, which demonstrated rapid and durable antidepressant effects from a single dose of BPL-003.
This designation is expected to expedite the development timelines and regulatory reviews for BPL-003, with Phase 3 trials anticipated to begin in the second quarter of 2026.