atai Life Sciences builds clinical momentum in first quarter of 2025
Published: 08:40 14 May 2025 EDT
atai Life Sciences (NASDAQ:ATAI, ETR:9VC) has kicked off 2025 with strong momentum across its clinical pipeline ahead of expected key data readouts later this year and into 2026.
Recent operational highlights include dosing the first patient in a Phase 2 trial of EMP-01 (oral R-MDMA) for social anxiety disorder and continued enrollment in the Elumina study evaluating VLS-01, a buccal film formulation of DMT, in treatment resistant depression.
Both programs are expected to deliver topline results in the first quarter of 2026.
“In the first quarter of 2025, we made meaningful progress across our pipeline, thus advancing our mission to transform the treatment of mental health conditions,” atai CEO Dr Srinivas Rao said in a statement.
“Dosing the first patient in our exploratory Phase 2 study of EMP-01 in social anxiety disorder represents a significant milestone in our quest to address an area of high unmet need with a novel therapeutic approach.”
Beckley Psytech’s Phase 2b trial of BPL-003, a mebufotenin-based intranasal therapy for treatment-resistant depression (TRD), remains on track for the release of topline data midyear.
Additional pipeline progress includes ongoing development of novel 5-HT2A receptor agonists with non-hallucinogenic properties, and continued advancement of RL-007, a pro-cognitive agent in Phase 2b development for cognitive impairment in schizophrenia through its investment in Recognify Life Sciences.
“Looking ahead, we are excited about the upcoming mid-year data readouts for BPL-003 in treatment-resistant depression and RL-007 in cognitive impairment associated with schizophrenia,” Dr Rao said.
“We believe that these milestones have the potential to reinforce our position as a leader in mental health innovation.”
Christian Angermayer, atai chairman, added: “Our progress this year reinforces my conviction in our mission and the long-term value we’re building, which is why I’ve continued to personally increase my investment in atai.”
“With a robust pipeline, strategic clarity, and growing momentum, we are well-positioned to deliver both transformative outcomes for patients in need and strong returns for shareholders,” Angermayer said.
Financial highlights
atai reported a net loss of $26.4 million in Q1 2025, roughly in line with the year-ago quarter.
Research and development (R&D) expenses held steady at $11.3 million, while general and administrative (G&A) costs decreased to $10.6 million from $12.6 million in the year-ago period.
The company ended the quarter with $108.2 million in cash and equivalents, strengthened by recent equity financings, and expects to be funded into 2027.
