AtaiBeckley issues 2026 outlook, flags multiple clinical milestones
Published: 08:56 08 Jan 2026 EST
AtaiBeckley NV (NASDAQ:ATAI, XETRA:9VC) has outlined its outlook for 2026, highlighting anticipated clinical milestones and recent corporate developments ahead of its participation in the JP Morgan 44th Annual Healthcare Conference in San Francisco later this month.
The clinical-stage biotechnology company said it enters 2026 following the completion of the strategic combination of atai Life Sciences and Beckley Psytech, and its recent redomiciliation to the United States.
“Following the strategic combination of atai Life Sciences and Beckley Psytech completed last year and the recent corporate redomiciliation to the United States, we enter 2026 with meaningful momentum and a clear vision for the impact AtaiBeckley can deliver for people living with difficult-to-treat mental health conditions,” AtaiBeckley CEO Dr Srinivas Rao said in a statement.
“Our pipeline is maturing at a pivotal moment for innovation in the mental health treatment landscape, and with financial resources expected to support operations into 2029, we are well prepared to execute.”
Among its key programs, AtaiBeckley reported continued progress with BPL-003, a mebufotenin benzoate nasal spray being developed for treatment-resistant depression (TRD) and alcohol use disorder.
In July 2025, the company reported positive topline results from the eight-week, quadruple-masked, dose-finding core stage of a Phase 2b trial in TRD, which met its primary and key secondary endpoints. Both 8 mg and 12 mg single doses showed statistically significant reductions in depressive symptoms compared with a low-dose active control through Week 8.
Additional positive topline data from an open-label extension study were reported in November 2025, indicating that a second 12 mg dose administered eight weeks after the initial treatment was generally well-tolerated and produced sustained antidepressant effects for up to two months.
The company said it expects to provide guidance on its Phase 3 clinical program for BPL-003 in the first quarter of 2026, with trial initiation anticipated in the second quarter, pending the outcome of a scheduled end-of-Phase 2 meeting with the US Food and Drug Administration.
An additional cohort in an open-label Phase 2a study of BPL-003 in TRD is planned to begin in the first quarter of 2026, with initial data expected in the fourth quarter.
AtaiBeckley also outlined upcoming data for VLS-01, a dimethyltryptamine buccal film for TRD. Topline results are anticipated in the second half of 2026 from Elumina, a Phase 2, multicenter, double-blind, randomized, placebo-controlled trial evaluating repeated doses in 142 patients.
For EMP-01, an oral R-enantiomer of MDMA being studied for social anxiety disorder, the company noted that the last patient completed the final visit in an exploratory Phase 2a study in the fourth quarter of 2025, with topline data expected in the first quarter of 2026. In December 2025, AtaiBeckley also announced the issuance of a new US patent covering EMP-01, which is expected to provide exclusivity through 2043.
On the corporate front, AtaiBeckley said it completed its redomiciliation from the Netherlands to the United States in December 2025, with shares of the former entity exchanged on a one-for-one basis for common stock of the newly formed Delaware company.
The company’s shares continue to trade on Nasdaq under the symbol ‘ATAI.’ It also reported that its common stock was added to the Nasdaq Biotechnology Index in December 2025.
“Our presence at the JP Morgan Healthcare Conference provides us with an important opportunity to engage with investors and strategic partners and highlight the progress we’ve made so far and the value we believe AtaiBeckley is positioned to deliver in the months and years ahead,” Dr Rao concluded.
