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AtaiBeckley Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business and Clinical Update
Phase 3 pivotal program initiation for BPL-003 in treatment-resistant depression remains on track for Q2 2026 following successful End‑of‑Phase 2 meeting with
About this update from Ataibeckley Inc.
[{"type":"text","content":"Phase 3 pivotal program initiation for BPL-003 in treatment-resistant depression remains on track for Q2 2026 following successful End‑of‑Phase 2 meeting with the U.S. Food and Drug AdministrationOn-track for VLS-01 Phase 2 Elumina trial topline data readout anticipated in H2 2026Exploratory Phase 2a trial of EMP-01 in Social Anxiety Disorder met its primary safety and tolerability objective and demonstrated clinically meaningful improvements across key efficacy measuresCash runway through the planned early-2029 topline readouts from both Phase 3 pivotal studiesVirtual Investor Day scheduled for March 6, 2026 NEW YORK, March 06, 2026 (GLOBE NEWSWIRE) -- AtaiBeckley Inc. (NASDAQ: ATAI) (“AtaiBeckley” or the “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 fourth quarter and full year 2025 financial results and provided key regulatory, clinical and business updates. “Following our strategic combination of atai Life Sciences and Beckley Psytech, and U.S. redomiciliation, we have entered a pivotal execution phase,” said Srinivas Rao, M.D., Ph.D., Chief Executive Officer and Co-Founder of AtaiBeckley. “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. 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. 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.” Program Updates and Anticipated MilestonesBPL-003: mebufotenin benzoate nasal spray for TRD In March 2026, the Company announced a successful End‑of‑Phase 2 meeting with the FDA regarding the development of BPL‑003 for treatment‑resistant depression (TRD), a debilitating and chronic condition affecting millions of people around the world but with limited rapid-acting treatment options.The FDA ind...