AtaiBeckley clinical pipeline advances toward multiple late-stage data catalysts, Jefferies says

AtaiBeckley Inc. (NASDAQ:ATAI, XETRA:9VC) is moving toward a series of late-stage clinical inflection points in its psychedelic drug pipeline, with multiple Phase III and Phase II readouts expected over the next several years that could help define the outlook for its $1B portfolio, according to Jefferies analysts.

Following the company’s Q1 results and corporate update, the firm highlighted multiple programs targeting treatment-resistant depression (TRD) and related psychiatric conditions, including BPL-003, VLS-01, and EMP-01, as key drivers of upcoming clinical and data readouts.

Jefferies noted that BPL-003, an intranasal 5-MeO-DMT candidate that received Breakthrough Therapy Designation in October 2025, is set to begin two Phase III trials in the second quarter of 2026. The studies are expected to enroll about 650 patients in total, with primary efficacy assessed at Week 4 and blinded treatment lasting 12 weeks, followed by a long-term extension period. Final data from the program are anticipated in early 2029.

The analysts pointed to mid-stage results as supporting confidence in the program, citing Phase IIb data that showed rapid and durable improvements in depression symptoms following a single dose. The Phase III design includes both single-dose and repeated-induction dosing arms intended to evaluate efficacy, durability, and retreatment patterns.

“We think BPL-003, possibly one to two doses per year, is competitive to [Johnson & Johnson’s] Spravato, does up to 52 times per year,” they wrote.

Jefferies also highlighted VLS-01, a buccal film formulation of DMT, which is expected to report Phase II TRD data in the fourth quarter of 2026. The study will evaluate dosing over a 14-week period, with primary outcomes measured earlier in the trial. The analysts noted that results from this program could serve as a near-term catalyst for the stock.

In addition, EMP-01, an oral R-MDMA candidate being studied for social anxiety disorder, is awaiting further development decisions following early Phase IIa data that showed supportive efficacy signals.

More broadly, Jefferies described the psychedelic drug class as gaining momentum amid a series of positive clinical readouts and an evolving regulatory environment, including increased FDA engagement with novel psychiatric therapies.

The analysts also pointed to existing commercial precedent in rapid-acting depression treatments as a reference point for potential market adoption if late-stage trials are successful.