AtaiBeckley targets Q2 start for Phase 3 depression trial as pipeline advances

AtaiBeckley Inc. (NASDAQ:ATAI, XETRA:9VC) is preparing to motorboat its pivotal Phase 3 programme for its pb treatment-resistant slump therapy successful the 2nd 4th of 2026, portion projecting its currency reserves volition enactment operations into 2029 arsenic the institution advances aggregate intelligence wellness attraction candidates done objective development.

In a connection released alongside the company’s archetypal 4th net connected Tuesday, AtaiBeckley said its Phase 3 ReConnection programme for BPL-003, a mebufotenin benzoate nasal spray being developed for treatment-resistant slump (TRD), remains connected way to statesman successful Q2 2026 pursuing an End-of-Phase 2 gathering with the US Food and Drug Administration.

The pivotal Phase 3 programme volition see 2 studies, ReConnection-1 and ReConnection-2, enrolling astir 350 and 230 patients, respectively. Both studies volition measure alteration from baseline successful Montgomery–Åsberg Depression Rating Scale (MADRS) scores astatine Week 4 arsenic the superior endpoint and volition see a 52-week open-label extension.

AtaiBeckley besides said archetypal information from Part 4 of its Phase 2a BPL-003 study, evaluating a two-dose induction attack combined with SSRIs, remains connected way for Q4 2026.

The company’s VLS-01 program, a dimethyltryptamine (DMT) buccal movie for treatment-resistant depression, continues to advancement done the Elumina Phase 2 trial, with topline information expected successful the 4th fourth of 2026.

In addition, AtaiBeckley highlighted results from its EMP-01 Phase 2a proceedings successful societal anxiousness upset (SAD). The institution said the oral R-MDMA campaigner demonstrated “clinically meaningful and accordant improvements” crossed clinician-rated symptoms, patient-reported experiences and behavioral outcomes.

As of March 31, 2026, AtaiBeckley reported cash, currency equivalents and short-term securities of $209.9 million, compared with $220.7 cardinal astatine the extremity of 2025. The institution said its existent currency presumption is expected to money operations done anticipated BPL-003 Phase 3 topline readouts, with runway into 2029.

Research and improvement expenses for the 4th roseate to $17.4 cardinal from $11.3 cardinal a twelvemonth earlier, driven chiefly by accrued objective improvement enactment for BPL-003, VLS-01 and EMP-01, on with higher personnel-related costs pursuing the company’s strategical operation with Beckley Psytech successful November 2025.

General and administrative expenses accrued to $14.4 cardinal from $10.6 cardinal successful the prior-year quarter, portion nett nonaccomplishment attributable to stockholders widened to $29.8 cardinal from $26.4 cardinal a twelvemonth earlier.