AtaiBeckley Inc. (ATAI) saw its stock climb 7.8% to $4.14 on Tuesday, following the announcement that the company has initiated Phase 3 clinical trials for its lead depression candidate, BPL-003. The move marks a significant transition into late-stage testing for the biopharmaceutical firm, which specializes in psychedelic-based therapies.
CEO Srinivas Rao disclosed the development during the H.C. Wainwright 7th Annual Neuro Perspectives Hybrid Conference on June 15. “We just actually initiated our phase III program,” Rao stated, according to a transcript. The company had previously flagged the topic in a June 3 SEC filing, noting that management would discuss program updates at investor meetings throughout the month.
BPL-003 is a mebufotenin benzoate nasal spray being evaluated for treatment-resistant depression. The Phase 3 program consists of two studies: ReConnection-1, which will enroll approximately 350 patients, and ReConnection-2, with around 230 participants. Both trials will use the Montgomery-Åsberg Depression Rating Scale (MADRS) to measure changes in depressive symptoms at week four, based on clinician assessments.
AtaiBeckley now boasts three late-stage psychedelic compounds, with BPL-003 taking the lead. The company reported cash, cash equivalents, and short-term securities totaling $209.9 million as of March 31, which management believes is sufficient to fund operations into 2029. “Through our anticipated Phase 3 topline readouts,” Rao said, emphasizing the financial runway.
The company’s first-quarter net loss widened to $29.8 million from $26.4 million in the same period last year, driven by higher research and development costs. Despite the increased spending, investors have responded positively to the advancement of BPL-003, which has already received FDA breakthrough therapy designation based on earlier Phase 2b data showing rapid antidepressant effects lasting up to eight weeks.
AtaiBeckley faces competition in the psychedelic therapeutics space. Compass Pathways reported in February that its COMP360 psilocybin drug met its primary endpoint in a second Phase 3 trial for treatment-resistant depression. Meanwhile, GH Research published Phase 2b data for its inhaled mebufotenin candidate, GH001, in JAMA Psychiatry in March. Rao highlighted a potential advantage for BPL-003, noting that its psychedelic effects typically resolve within 90 minutes to two hours, offering a shorter in-clinic experience.
Phase 3 trials carry inherent risks, including potential delays, failure to meet endpoints, safety concerns, or regulatory hurdles. AtaiBeckley’s SEC filings caution that all statements regarding trial timelines, regulatory decisions, and cash runway are forward-looking and not guarantees of future results.
Looking ahead, the company expects to release topline results from the VLS-01 Elumina Phase 2 study and the first data from BPL-003 Phase 2a Part 4 in the fourth quarter of this year. BPL-003 Phase 3 topline data are anticipated in early 2029.
