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…
ntal 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
The pivotal Phase 3 program will include two studies, ReConnection-1 and ReConnection-2, enrolling about 350 and 230 patients, respectively. Both studies will evaluate change from baseline in Montgomery–Åsberg Depression Rating Scale (MADRS) scores at Week 4 as the primary endpoint and will include a 52-week open-label extension. AtaiBeckley also said initial data from Part 4 of its Phase 2a BPL-003 study, evaluating a two-dose induction approach combined with SSRIs, remains on track for Q4 2026.
The company’s VLS-01 program, a dimethyltryptamine (DMT) buccal film for treatment-resistant depression, continues to progress through the Elumina Phase 2 trial, with topline data expected in the fourth quarter of 2026. In addition, AtaiBeckley highlighted results from its EMP-01 Phase 2a trial in social anxiety disorder (SAD). The company said the oral R-MDMA candidate demonstrated “clinically meaningful and consistent improvements” across clinician-rated symptoms, patient-reported experiences and behavioral outcomes.