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AtaiBeckley Inc. (NASDAQ:ATAI, XETRA:9VC) is preparing to launch its pivotal Phase 3 program for its lead treatment-resistant depression therapy in the second quarter of 2026, while projecting its cash reserves will support operations into 2029 as the company advances multiple mental health treatment candidates through clinical development. In a statement released alongside the company's first quarter earnings on Tuesday, AtaiBeckley said its Phase 3 ReConnection program for BPL-003, a mebufotenin benzoate nasal spray being developed for treatment-resistant depression (TRD), remains on track to begin in Q2 2026 following an End-of-Phase 2 meeting with the US Food and Drug Administration.

Phase 3 pivotal program initiation for BPL-003 in treatment-resistant depression on track for Q2 2026 VLS-01 Phase 2 Elumina topline results anticipated in Q4 2026 Consistent, convergent improvements demonstrated in EMP-01 Phase 2a trial across independent clinician-rated and patient-reported outcomes in Social Anxiety Disorder Cash and cash equivalents expected to fund operations through anticipated BPL-003 Phase 3 topline readouts, with runway into 2029 NEW YORK, May 12, 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 reported financial results for the first quarter ended March 31, 2026, and provided a business update across its clinical pipeline. First Quarter 2026 Highlights BPL-003 (TRD): Phase 3 pivotal ReConnection program on track to initiate in Q2 2026.

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The Trump administration's April 2026 executive order in support of psychedelic drugs may have flown under the radar for many investors in the midst of the Iran war and numerous other high-profile domestic political news stories, but the implications for this small but growing industry are tremendous. Indeed, within days, the FDA began to make moves, awarding national priority vouchers to select companies developing drugs in this category, thereby reducing drug review times considerably.

AtaiBeckley Inc. (NASDAQ:ATAI, XETRA:9VC) said on Monday it had received the Silver Award in OVID Health's 2026 Patient Participant Index, recognizing its collaboration with the Psychedelic Participant Advocacy Network (PsyPAN) to strengthen participant involvement in psychedelic clinical research. The clinical-stage biotechnology company said the award highlights a multiyear partnership aimed at incorporating the lived experiences of clinical trial participants into the development of mental health treatments.

NEW YORK, April 27, 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 it has received the Silver Award in OVID Health's 2026 Patient Participant Index (PPI), in collaboration with the Psychedelic Participant Advocacy Network (PsyPAN), in recognition of their joint efforts to strengthen participant partnership in psychedelic clinical research. The recognition highlights AtaiBeckley's multiyear collaboration with PsyPAN to integrate the lived experiences of clinical trial participants into the responsible development of novel mental health therapies and amplify these learnings across the sector.

NEW YORK, April 22, 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 expanded Phase 2a results for EMP-01 (oral R-MDMA) in adults with Social Anxiety Disorder (SAD) (n=70), demonstrating clinically meaningful and consistent improvements across clinician-rated symptoms, patient-reported experience, and real-world behavioral outcomes. At Day 43, EMP‑01 achieved a 38% reduction vs 15% on placebo (Hedges' g=0.84) on the patient-reported Social Phobia Inventory (SPIN), a 32% reduction vs 14% on placebo on the Subtle Avoidance Frequency Examination (SAFE), and a previously reported −11.9-point LS mean difference (LSMD) on the Liebowitz Social Anxiety Scale (LSAS) versus placebo (g=0.45), with 49% responder rates on both Clinical Global Impression-Improvement (CGI-I) (previously reported) and Patient Global Impressions of Change (PGI-C). EMP-01 was well tolerated, with no severe or serious adverse events.