AtaiBeckley Inc: 1Q26: Psychedelic Pipeline Advancing with Data Readouts in 4Q26

研报英文原文证据摘录

AtaiBeckley Inc: 1Q26: Psychedelic Pipeline Advancing with Data Readouts in 4Q26

13 May 2026

AtaiBeckley Inc

In 4Q26, ATAI will report topline placebo-controlled Ph2 Elumina data for VLS-

01 (TRD), which we expect to be the largest catalyst for the stock in 2026. Mgmt.

believes hitting stat. sig. on the primary endpoint (MADRS at Week 4) and

showing a delta of 3-4 points or more for VLS-01 120mg over placebo would be

a good outcome that supports further development. Mgmt. is also interested in

seeing how the two-dose induction regimen (Day 1 and Week 2) performs on

durability; while primary endpoint is at Week 4, the double-blind period will collect

data up to Week 14. Mgmt. noted it’s possible the second booster dose only

modestly improves efficacy (recall CMPS’ data where second dose was less

impactful than expected), but could be important for enhancing durability.

Elumina contains a second treatment period, where patients completing the first

14-week period are randomized to VLS-01 120mg vs. 60mg for 2 weeks. Mgmt.

clarified this portion of the study was intended to generate data across multiple

doses in the therapeutic range (looking for potential dose response), where others

have adopted similar dosing in their studies at the FDA’s request, such as CMPS’

COMP360 with 25mg vs. 10mg and DFTX’s DT120 with 100µg vs. 50µg.

On EMP-01 in SAD, ATAI intends to conduct an additional dose-ranging study

(pending capital availability) prior to initiating a Ph3 registrational program.

Mgmt. had selected the maximum tolerated dose (MTD) of 225mg for the Ph2a

study, and emphasized doing more dose-ranging work and optimizing study

design before committing to larger registrational trials. Given the LSAS efficacy

endpoint is a behavior-focused scale, mgmt.