BPL-003 Phase 3 preparation on track for Q2 2026 after successful FDA End-of-Phase 2 meeting, AtaiBeckley highlights 2026 Investor Day milestones

BPL-003 (mebufotenin benzoate nasal spray) is positioned for Phase 3 initiation in Q2 2026 after a successful FDA End-of-Phase 2 meeting, with the program intended to start two parallel pivotal trials (ReConnection-1 and ReConnection-2). Phase 3 design includes a 12-week randomized, double-blind, placebo-controlled core study, followed by a 52-week open-label extension with individualized retreatment based on pre-specified criteria. The update ties the plan to prior Breakthrough Therapy Designation and positive Phase 2b results in treatment-resistant depression (TRD), including rapid antidepressant effects at Day 2 and durable improvements through about eight weeks, plus higher response and remission with an optional second dose. AtaiBeckley also reiterates its cash runway into early 2029 and emphasizes commercial and operational readiness. The company describes a scalable, clinic-compatible treatment model aligned with existing interventional psychiatry workflows, aiming to avoid requiring in-session psychotherapy and to support broader patient access.