AtaiBeckley NV (NASDAQ:ATAI, ETR:9VC) reported continued clinical and operational progress during the third quarter of 2025, advancing multiple programs targeting treatment-resistant depression (TRD) and other mental health conditions.
During the quarter, the company’s lead candidate BPL-003, a mebufotenin (5-MeO-DMT) benzoate nasal spray, was granted Breakthrough Therapy designation by the US Food and Drug Administration (FDA) for TRD.
AtaiBeckley also reported positive topline results from the open-label extension of its global Phase 2b trial, which showed that a second 12 mg dose administered eight weeks after an initial treatment was generally well tolerated and produced additional antidepressant effects sustained for up to two months.
The company completed an End-of-Phase 2 meeting with the FDA and expects to provide guidance on the Phase 3 clinical program for BPL-003 in the first quarter of 2026, with trial initiation anticipated in Q2.
AtaiBeckley also advanced its VLS-01 (buccal film DMT) program for TRD, expanding enrollment in the Phase 2 Elumina trial across the US, Australia, and the UK. Topline data is expected in the second half of 2026.
In addition, patient enrollment was completed for the exploratory Phase 2a study of EMP-01, an oral R-MDMA compound for social anxiety disorder, with results anticipated in the first quarter of 2026.
Further, AtaiBeckley reported progress in the discovery of novel 5-HT2A receptor agonists with non-hallucinogenic potential. The company received a multi-year, milestone-driven grant worth up to $11.4 million from the National Institute on Drug Abuse to support the early-stage development for opioid use disorder.
Corporate developments during the quarter included the completion of the strategic combination between Atai Life Sciences and Beckley Psytech, forming AtaiBeckley. The company’s shareholders also ratified plans to redomicile to the US, with completion expected around year-end 2025.
In October, AtaiBeckley raised approximately $150 million through a public offering, extending its cash runway into 2029, which includes funding through expected topline data from the first Phase 3 trial of BPL-003.
As of September 30, 2025, AtaiBeckley held $114.6 million in cash, cash equivalents, and short-term securities, compared with $72.3 million at year-end 2024. The increase primarily reflected proceeds from equity issuances, offset by operating expenses and debt repayments.
Research and development expenses totaled $14.7 million during Q3, up from $12.4 million a year earlier, mainly due to higher clinical program costs.
General and administrative expenses rose to $14.5 million from $10.3 million, reflecting legal and professional costs tied to the Beckley Psytech merger and US redomiciliation process.
AtaiBeckley reported a net loss attributable to shareholders of $61.1 million for the third quarter, compared with a net loss of $26.3 million in the same period last year. The latest quarter included a $32.6 million non-cash expense related to changes in the fair value of certain assets and liabilities.