AtaiBeckley Inc. (NASDAQ:ATAI, XETRA:9VC) has reported its fourth quarter and full-year 2025 financial results, highlighting progress across several clinical programs targeting mental health disorders and outlining upcoming milestones for its pipeline.
The clinical-stage biotechnology company said it remains on track to initiate a Phase 3 pivotal program for BPL-003, its mebufotenin benzoate nasal spray for treatment-resistant depression (TRD), in the second quarter of 2026.
The timeline follows a successful End-of-Phase 2 meeting with the US Food and Drug Administration, which indicated support for advancing the therapy into late-stage studies and provided feedback on the potential regulatory pathway.
The planned Phase 3 program will consist of two randomized, placebo-controlled trials, ReConnection-1 and ReConnection-2, evaluating the therapy in adults with TRD. Each study will include a 12-week core trial followed by a 52-week open-label extension. Topline results from the core studies are expected by early 2029.
The company is also advancing VLS-01, a dimethyltryptamine (DMT) buccal film designed to fit within a two-hour interventional psychiatry treatment model for TRD. Topline data from the Phase 2 Elumina study are anticipated in the second half of 2026.
Another program, EMP-01, an oral R-enantiomer of MDMA being studied for social anxiety disorder, recently reported results from an exploratory Phase 2a trial. The study met its primary safety and tolerability objective and showed placebo-adjusted improvements on the Liebowitz Social Anxiety Scale, along with a higher responder rate compared with placebo.
During 2025, the company also completed a strategic combination between atai Life Sciences and Beckley Psytech, forming AtaiBeckley. The company subsequently redomiciled to the United States as a Delaware-incorporated firm headquartered in New York and was added to the NASDAQ Biotechnology Index in December.
Srinivas Rao, AtaiBeckley’s CEO, said the company has entered a pivotal executions phase following the strategic combination of atai Life Sciences and Beckley Psytech, and US redomiciliation.
“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,” Rao said.
“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.”
As of December 31, 2025, the company reported cash, cash equivalents, and short-term securities of $220.7 million, up from $72.3 million a year earlier. The increase was primarily driven by $291.1 million in net proceeds from equity-related issuances and $9.1 million from the sale of equity holdings, partially offset by operational spending and other payments related to the Beckley Psytech transaction and debt repayment.
Research and development expenses totaled $53.1 million for the full year, compared with $55.5 million in 2024, reflecting lower personnel and consulting costs partly offset by higher clinical and manufacturing spending.
General and administrative expenses rose to $65.1 million for the year from $47.5 million, largely due to legal and professional service costs associated with the Beckley Psytech combination and the company’s redomiciliation to the United States.
AtaiBeckley reported a net loss attributable to stockholders of $660 million for 2025, compared with a loss of $149.3 million in the prior year. The 2025 results included approximately $530 million in non-cash acquisition-related research and development expenses linked to the Beckley Psytech transaction.
The company said its current cash position is expected to fund operations into 2029, including through the anticipated topline readouts from the planned Phase 3 studies of BPL-003.
Further, AtaiBeckley plans to discuss the BPL-003 Phase 3 development strategy and the broader commercial opportunity in treatment-resistant depression during a virtual investor day scheduled for March 6.
“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,” Rao concluded.