AtaiBeckley announced its fourth quarter and full-year 2025 financial results and provided regulatory, clinical and business updates.

AtaiBeckley Inc. (NASDAQ: ATAI) ("AtaiBeckley" or the "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 fourth quarter and full year 2025 financial results and provided key regulatory, clinical and business updates.

"Following our strategic combination of atai Life Sciences and Beckley Psytech, and U.S. redomiciliation, we have entered a pivotal execution phase," said Srinivas Rao, M.D., Ph.D., Chief Executive Officer and Co-Founder of AtaiBeckley. "We received constructive feedback from the FDA on the Phase 3 development plan for BPL-003 in treatment-resistant depression, positioning us to initiate our pivotal program in the second quarter of 2026. We also reported positive topline results from our exploratory Phase 2a study of EMP-01 in Social Anxiety Disorder, which met its primary safety objective and demonstrated clinically meaningful improvements across key efficacy measures after just two administrations and without adjunct psychotherapy. With multiple clinical catalysts ahead and capital expected to fund operations into 2029, we believe AtaiBeckley is well positioned to advance a differentiated portfolio of rapid-acting mental health therapies."

Program Updates and Anticipated Milestones

BPL-003: mebufotenin benzoate nasal spray for TRD

In March 2026, the Company announced a successful End-of-Phase 2 meeting with the FDA regarding the development of BPL-003 for treatment-resistant depression (TRD), a debilitating and chronic condition affecting millions of people around the world but with limited rapid-acting treatment options.

The FDA indicated support for advancement into Phase 3 studies in adults with TRD and provided constructive feedback on the overall design and requirements for a potential NDA package for this indication.

The Phase 3 program is designed to include two pivotal studies, ReConnection-1 and ReConnection-2, each consisting of a 12-week, randomized, double-blind, placebo-controlled core study followed by a 52-week open-label extension (OLE):ReConnection-1:

Approximately 350 participants

Single-dose of BPL-003 across three treatment arms - 8 mg, 4 mg, and placebo (randomized 2:1:2)

Designed to replicate and extend Phase 2b treatment response and further characterize dose–response relationship for BPL-003

ReConnection-2:

Approximately 300 participants

Two-dose design (Day 1 and Day 15) across two arms - 8 mg BPL-003 and placebo (randomized 1:1)

Designed to evaluate if a two-dose induction model increases magnitude and durability of initial response

The primary endpoint in both pivotal trials will be the change from baseline in the MADRS total score at Week 4.

Both trials include a 52-week OLE allowing individualized 8 mg BPL-003 retreatment at 8- or 12-week intervals with the aim of maintaining remission.

Phase 3 program initiation remains on track for Q2 2026.

Topline data from the core studies of both ReConnection-1 and –2 anticipated by early 2029.

First patient dosed in the Part 4 cohort of the open-label Phase 2a study, evaluating a two-dose induction regimen (8 mg + 8 mg) of BPL-003 in TRD patients receiving defined antidepressants. Initial data expected in Q4 2026.

 

VLS-01: dimethyltryptamine (DMT) buccal film for TRD

VLS-01 is an investigational proprietary oral transmucosal film formulation of DMT applied to the buccal surface, designed to fit within the established two-hour interventional psychiatry treatment paradigm.

Phase 2 Elumina study topline data readout is anticipated in H2 2026.

 

EMP-01: Oral R-enantiomer of 3,4-methylenedioxy-methamphetamine (R-MDMA) for social anxiety disorder (SAD)

In February 2026, the Company reported topline results from the exploratory, randomized, double-blind, placebo-controlled Phase 2a trial of EMP-01 in SAD:Key findings:

Met primary safety and tolerability objective with a generally favorable and manageable profile

Clinically meaningful placebo-adjusted least squares mean reduction of 11.85 points on the Liebowitz Social Anxiety Scale (LSAS) at Day 43 (Hedges' g = 0.45; p-value = 0.036, one-tailed)

49% responder rate on Clinician Global Impression–Improvement (CGI-I) vs. 15% for placebo, corresponding to a Number Needed to Treat (NNT) of 2.95

Demonstrated improvements across Fear and Avoidance sub-domains of LSAS

In December 2025, the Company was granted a new U.S. patent covering the EMP-01 drug substance, extending expected exclusivity through 2043.

More detailed analyses of the data will be described in upcoming scientific venues and are expected to inform next development steps.

 

Business Highlights

Completed the strategic combination in November 2025 between atai Life Sciences N.V. and Beckley Psytech Limited, creating AtaiBeckley, a global leader in transformative mental health therapies.

Completed the redomiciliation to the United States in December 2025 as a Delaware-incorporated company with headquarters in New York, NY.

AtaiBeckley Inc. was added to the NASDAQ Biotechnology Index (NBI) in December 2025.

The Company will host a Virtual Investor Day on March 6, 2026, centered on BPL-003 and the Phase 3 development strategy.

The Virtual Investor Day will feature:

Detailed overview of the BPL-003 Phase 3 program

Discussion of the commercial opportunity in treatment-resistant depression

Key opinion leader roundtable discussing the evolving psychedelic therapeutic landscape and operational considerations in interventional psychiatry

 

Upcoming Anticipated Milestones and Events

March 6, 2026: Virtual Investor Day

Q2 2026: Initiation of BPL-003 Phase 3 ReConnection-1 and ReConnection-2 trials

H2 2026: Topline data from VLS-01 Elumina Phase 2 study

Q4 2026: Initial data from Phase 2a BPL-003 Part 4 cohort

 

Consolidated Financial Results

Cash, cash equivalents, and short-term securities (primarily US treasuries): As of December 31, 2025, the Company had cash, cash equivalents and short-term securities of $220.7 million compared to $72.3 million of cash, cash equivalents, restricted cash and short-term securities as of December 31, 2024. The $148.4 million increase is primarily attributable to $291.1 million in net proceeds from equity-related issuances and $9.1 million in proceeds from sale of equity holdings, partially offset by $102.7 million used in operations, $21.8 million payoff of Hercules debt facility, $20.0 million in payments relating to the Beckley Psytech investment prior to the strategic combination, and $10.0 million investment in digital assets. The Company expects its cash, cash equivalents, short-term investments and other liquid assets to fund operations into 2029.

Research and development (R&D) expenses: R&D expenses were $19.0 million and $53.1 million for the three and twelve months ended December 31, 2025, respectively, as compared to $18.9 million and $55.5 million for the same prior year periods. The year-over-year full-year decrease of $2.4 million was primarily attributable to decreased personnel-related expenses and consulting services, partially offset by higher clinical program contract research organizations and manufacturing costs.

We recorded non-cash acquisition of in-process R&D expenses of $527.0 million and $530.0 million for the three and twelve months ended December 31, 2025, respectively, primarily relating to the strategic combination with Beckley Psytech.

General and administrative (G&A) expenses: G&A expenses for the three and twelve months ended December 31, 2025, were $25.1 million and $65.1 million, respectively, as compared to $11.3 million and $47.5 million in the same prior year periods. The year-over-year increase of $17.6 million was primarily attributable to increased legal and professional service expenses in connection with the Beckley Psytech strategic combination and the Company's redomiciliation to the United States, partially offset by decreases in personnel-related expenses.

Net income (loss): Net loss attributable to stockholders for the three and twelve months ended December 31, 2025, was $544.8 million and $660.0 million, respectively, as compared to $39.0 million and $149.3 million for the comparable prior year periods. Net loss attributable to stockholders for the twelve months ended December 31, 2025, includes $24.4 million non-cash reduction in the fair value of assets and liabilities, net, $14.2 million of non-cash stock-based compensation, and $10.7 million non-cash gain related to the investment in Beckley Psytech. Net loss attributable to stockholders for the twelve months ended December 31, 2024, includes $48.9 million non-cash reduction in the fair value of assets and liabilities, net and $25.5 million of non-cash stock-based compensation.

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