Atai Beckley N.V. disclosed that the Phase IIb open‑label extension of its intranasal mebufotenin benzoate, BPL‑003, produced robust and sustained antidepressant effects. The study enrolled 126 patients in the core phase and 107 in the extension; a 12 mg dose administered eight weeks after the core study yielded additional rapid and clinically meaningful improvements that persisted for up to eight weeks. In the core cohort, the 0.3 mg group achieved a mean MADRS reduction of 14.0 points at Day 57, while the 8 mg group recorded a 22.3‑point reduction, an 81 % responder rate and a 67 % remission rate. The pooled 8 mg/12 mg cohort reported a 19‑point mean reduction, a 63 % responder rate and a 48 % remission rate, with safety and tolerability consistent with earlier studies.
The data support advancing the 8 mg dose into a Phase III program and reinforce the company’s Breakthrough Therapy designation for BPL‑003. An End‑of‑Phase 2 meeting with the U.S. Food and Drug Administration is scheduled, and guidance on the Phase III design is expected in the first quarter of 2026, with trial initiation planned for the second quarter pending FDA discussions. The results validate the company’s intermittent‑dose paradigm, offering a short psychedelic duration that can be integrated into existing clinical workflows and potentially reduce the burden on patients and providers.
Srinivas Rao, Atai Beckley’s CEO, emphasized that the new data “provide compelling support that redosing with BPL‑003 may deliver additional and durable antidepressant effects in patients with treatment‑resistant depression while maintaining a favorable safety and tolerability profile.” He added that the 2‑hour clinic time required for the 12‑mg dose is comparable to the Spravato paradigm, underscoring the practical advantages of the intermittent‑dose approach.
Financially, Atai Beckley has faced declining revenue growth and negative net and operating margins, with a cash runway that extends to 2029. The company’s heavy investment in clinical development and limited commercial revenue have contributed to these headwinds. Despite the financial challenges, the positive clinical data are expected to bolster investor confidence and support future financing efforts needed to sustain the Phase III program.
BPL‑003 remains the lead asset in Atai Beckley’s pipeline, which also includes VLS‑01 (a DMT buccal film) and EMP‑01 (an oral R‑MDMA) in Phase II development. The company was formed in November 2025 through the combination of atai Life Sciences and Beckley Psytech, bringing together complementary scientific expertise. The intermittent‑dose paradigm positions BPL‑003 against competitors such as Compass Pathways and the established Spravato therapy. Investors have responded positively to the robust efficacy data and Breakthrough Therapy designation, although valuation concerns persist due to the company’s financial constraints.
The positive OLE results reinforce Atai Beckley’s trajectory toward regulatory approval, but the financial headwinds underscore the need for continued capital raising and efficient resource allocation. The company’s next steps include the FDA meeting, Phase III trial design, and potential partnership or funding to sustain development and bring BPL‑003 to market.
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