atai Life Sciences entering 'catalyst-rich period,' Jefferies says
Published: 11:18 18 Mar 2025 EDT
atai Life Sciences (NASDAQ:ATAI, ETR:9VC) is entering a pivotal period with data from several key trials expected in 2025 and 2026, analysts at Jefferies have highlighted following the company's fourth quarter update.
“We see a catalyst-rich period with five-plus Phase 2/3 central nervous systems/neuro readouts in 2025 to 2026,” the analysts wrote in a note to clients.
These upcoming readouts and a friendlier administration may improve market sentiment towards atai.
Analysts highlighted the upcoming release of data from a Phase 2b trial of BPL-003, a 5-MeO-DMT therapy for treatment-resistant depression, expected in mid-2025. BPL-003 is being advanced by private biotechnology firm Beckley Psytech, in which atai is invested.
The trial, which is set to conclude enrollment in March 2025, will provide insight into the compound's efficacy, with a focus on MADRS (Montgomery-Åsberg Depression Rating Scale) improvement. atai is aiming for a 5-point benefit over placebo at Day 28.
This aligns with prior promising results from an open-label Phase 2a study, where BPL-003 showed substantial remission rates, further supported by prior positive data from GH001's inhaled 5-MeO-DMT for similar indications, the analysts highlighted.
High-potential trials
“For BLP-003, we think a breakthrough therapy designation is possible post Phase 2b data,” Jefferies wrote.
The analysts noted that atai’s portfolio includes several other high-potential trials in addition to BPL-003.
RL-007, a GABA/nicotinic modulator, will provide Phase 2b data on cognition and neurocognitive performance in schizophrenia in mid-2025. This follows promising early-stage data indicating strong efficacy on cognition, a critical aspect of managing schizophrenia.
The company also has two Phase 2 trials in 2026: EMP-01 (R-MDMA) for social anxiety and VLS-01 (DMT) for treatment-resistant depression, both of which have shown early promise in Phase 1 studies.
The analysts repeated their ‘Buy’ rating on atai and awarded it a $5 price target, implying upside of about 240% from its share price at the time of writing.