AtaiBeckley Doses Last Patient in VLS-01 Phase 2b TRD Study; Plans Phase 3 in Major Depressive Disorder

156 patients randomized in multi-center, double-blind, placebo-controlled Phase 2b Elumina trial; topline data anticipated in Q4 2026 (ClinicalTrials.gov: NCT06524830 ) AtaiBeckley plans to advance VLS-01 into major depressive disorder (MDD) in Phase 3, with generalized anxiety disorder (GAD) as a potential follow-on indication VLS-01 and BPL-003 (in Phase 3 development for treatment-resistant depression with Breakthrough Therapy Designation) together positioned to address patients across the spectrum of mood and anxiety disorders NEW YORK, July 06, 2026 (GLOBE NEWSWIRE) -- AtaiBeckley Inc. (NASDAQ: ATAI) (“AtaiBeckley” or “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 that the last patient has been dosed in Elumina, its Phase 2b clinical trial evaluating VLS-01 in adults living with treatment-resistant depression (TRD). The study randomized 156 patients, with topline data expected in Q4 2026. Study Overview Investigational product: VLS-01 Formulation: Proprietary oral transmucosal film formulation of N,N-Dimethyltryptamine (DMT) Mechanism of action: Serotonin agonist at 5HT 1 /2/6/7 receptors Indication: Treatment-resistant depression Study name: Elumina Design: Multi-center, double-blind, randomized, placebo-controlled Phase 2b. 156 patients randomized 1:1 ClinicalTrials.gov identifier NCT06524830 Primary outcome: VLS-01 versus placebo mean change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Day 29 Secondary and exploratory outcomes: Placebo-adjusted mean change from Baseline in MADRS total score at weeks 6 and 14, Columbia-Suicide Severit...