The atai Life Sciences (NASDAQ:ATAI, ETR:9VC) story has become more attractive following the release of robust Phase 2b trial results for BPL-003 in treatment-resistant depression, analysts at Jefferies believe.
BPL-003, an intranasal formulation of DMT developed in partnership in Beckley Psytech, demonstrated rapid, robust and durable antidepressant effects with a single dose.
Analysts at Jefferies upped their price target on atai to $7 from $6. Shares of atai have surged 25% on the results to $2.80.
They see BPL-003 as differentiated from other psychedelics due to its single-dose durability and short, 2-hour in-clinic paradigm.
“We believe the Street will understand the various nuances of BPL-003, COMP360 (psilocybin) and GH001 (inhaled 5-MeO-DMT) in terms of their drug profiles, study designs and trial execution,” they wrote.
“In any case, we believe Beckley has produced one of the most differentiated psychedelic datasets to date. In particular, we like BPL-003's single-dose durability, which has positive implications to sales.”
Jefferies estimates the product’s peak sales potential to exceed $1 billion, and with a 65%+ probability of success (PoS), values the program at over $2 billion.
Spravato sales are expected to reach $3 billion by 2027, despite the need for frequent dosing, up to 52 times a year. By contrast, BPL-003 may require only one dose every two to three months.
The analysts see atai’s stock climbing higher on a few events within the next three to nine months.
In the third quarter of 2025, the company is expected to release additional durability and redosing data from both an open-label extension (OLE) study and a two-dose induction study. These results will help shape the design of the upcoming Phase III trial for BPL-003.
In the second half of 2025, ATAI plans to meet with the FDA to discuss the regulatory path forward. This meeting may determine whether the existing Phase IIb data could serve as one of the two pivotal trials required for approval. The company also sees a potential opportunity to receive Breakthrough Therapy Designation (BTD) during this period.
Looking ahead to the first quarter of 2026, ATAI is scheduled to report Phase II results from two additional programs: VLS-01, a buccal film formulation of DMT for treatment-resistant depression, and EMP-01, an oral R-MDMA candidate being developed for social anxiety.
Jefferies also pointed to an improving macro backdrop, with Johnson & Johnson providing the commercial viability of their nasal esketamine spray Spravato and the Food and Drug Administration (FDA) and Department of Health and Human Services showing support for psychedelics.
Additionally, the FDA’s recently proposed “National Priority Vouchers” program could slash New Drug Application times from the typical 10 to 12 months to just one to two months.