atai Life Sciences shares gain momentum ahead of pivotal trial readouts

atai Life Sciences (NASDAQ:ATAI, ETR:9VC)’ stock is poised to climb significantly, driven by a series of clinical catalysts this year and next, analysts at Jefferies wrote following the release of the company’s first quarter results.

The analysts repeated their ‘Buy’ rating and $5 price target on atai, which traded up 11.8% at $1.60 on Thursday afternoon.

Jefferies highlighted in a note that atai is approaching a critical phase in its development pipeline.

"atai has multiple Phase 2/3 datasets over the next three to nine months that could strengthen the narrative psychedelics have an important place in psychiatry, by potentially showing profound and durable efficacy for hard-to-treat $1 billion+ central nervous system disorders," they wrote.

Among the most anticipated catalysts is mid-2025 Phase 2b data for BPL-003, a psychedelic intranasal 5-MeO-DMT formulation being developed by Beckley Psytech, in which atai holds a 34% equity stake.

The study is testing BPL-003 in treatment-resistant depression (TRD), with a randomized, controlled 8-week design involving 196 patients.

Despite not directly controlling the program, Jefferies expects a positive readout would significantly benefit atai.  "A positive readout should still yield upside to atai stock,” they wrote.

The analysts estimate that if BPL-003 reaches $1 billion in peak sales, applying a 3x revenue multiple, a 65% chance of success, and atai’s 33.6% ownership stake, the asset could be worth over $650 million to atai, more than double the company’s $280 million market cap at the time of writing.

The trial is comparing 12mg and 8mg doses to a sub-active 0.3mg dose at the 4-week MADRS primary endpoint.

Jefferies noted that while the sub-active dose may still show some efficacy, "We’d like to see a 5-point MADRS separation at Week 4,” they wrote.

For context, they point to Spravato, Johnson & Johnson’s esketamine nasal spray for TRD, which showed a -5.1 to -6.8 placebo adjusted MADRS at Day 28 in a Phase 4 monotherapy TRD study.

The analysts also highlighted comparisons with GH Research’s GH001, another 5-MeO-DMT candidate that posted a much larger placebo-adjusted MADRS benefit at Day 8.

However, they cautioned: "BPL-003’s subactive 0.3mg should show an effect and its primary endpoint is Day 28, so we’d expect a smaller MADRS delta."

Additional catalysts

Atai also has a small 7% stake in COMPASS Pathways, which is set to report Phase 3 results for COMP360, its oral psilocybin program in TRD, by late June.

Two additional programs are expected to report data in Q1 2026.

For EMP-01 (oral R-MDMA) in social anxiety disorder, a Phase 2 placebo-controlled trial is following two 225mg doses administered 4 weeks apart. EMP-01 showed differentiated subjective experiences compared to racemic MDMA in earlier studies, the analysts noted.

The other trial is evaluating VLS-01 (buccal film DMT) in TRD, testing two 120mg doses across two weeks with MADRS assessments at Week 4 and follow-up through Week 14. The analysts see potential for differentiated attributes compared to the standard of care and other DMT approaches, including fast-acting properties for shorter clinic visits and durable effects for episodic dosing. 

“We are most keen on BPL-003 in TRD, VLS-01 for TRD, and EMP-01 for social anxiety,” Jefferies wrote. “Importantly, these compounds can fit in the two-hour, in-clinic treatment paradigm established by Spravato in TRD. Also, overall sentiment could improve with a friendlier administration.”