AtaiBeckley Enters 2026 with Positive Outlook, BPL-003 Clinical Trial Data Strong

Dr Srinivas Rao, Co-Founder and Chief Executive Officer of AtaiBeckley, said: "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. 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. Our presence at the J.P. 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." BPL-003: mebufotenin benzoate nasal spray for treatment-resistant depression and alcohol use disorder: Reported positive topline data from the eight-week, quadruple-masked, dose-finding, core stage of the Phase 2b clinical trial evaluating the efficacy and safety of a single dose of BPL-003 in patients with treatment-resistant depression in July 2025. The study met its primary and all key secondary endpoints, and BPL-003 demonstrated rapid, robust and durable antidepressant effects with a single dose. Both 8 mg and 12 mg single doses of BPL-003 showed statistically significant and clinically meaningful reductions in depressive symptoms at all time points of the study compared to a 0.3 mg low-dose active control out to Week 8. Reported positive topline data from the eight-week open-label extension study of the Phase 2b clinical trial of BPL-003 in patients with TRD in November 2025. The findings showed that a 12 mg dose of BPL-003, administered eight weeks after an initial dose, was generally well-tolerated and produced additional clinically meaningful antidepressant effects that were sustained for up to two months. Company anticipates providing guidance on the BPL-003 Phase 3 clinical program in Q1'26 with Phase 3 trial initiation in Q2'26, pending outcome of the scheduled End-of-Phase 2 meeting with the U.S. Food and Drug Administration. Initiation of an additional cohort in an open-label Phase 2a study of BPL-003 in patients with TRD planned in Q1'26, with initial data expected in Q4'26. The study will evaluate a two-dose induction regimen of BPL-003, where patients who are also taking defined antidepressants will be given an 8 mg dose of BPL-003 followed by a second 8 mg dose two weeks later, and then followed for a further 10 weeks. VLS-01: dimethyltryptamine buccal film for TRD: Company anticipates topline data from Elumina, the Phase 2, multicenter, double-blind, randomized, placebo-controlled trial of repeated doses of VLS-01 in 142 patients with TRD in H2'26. EMP-01: Oral R-enantiomer of 3,4-methylenedioxy-methamphetamine for social anxiety disorder Announced granting of new patent covering EMP-01 from the United States Patent and Trademark Office in December 2025. US patent No. 12,492,178 includes claims to a highly-crystalline form of (R)-MDMA HCl and is expected to provide exclusivity through 2043. Last patient last visit in the exploratory Phase 2a study of EMP-01 in approximately 70 adults with social anxiety disorder occurred in Q4 '25, with topline data expected in Q1'26.