Atai Life Sciences (ATAI) investor relations material

Key clinical data and program updates

• Phase 2b data for BPL-003 showed a significant MADRS difference at day 29, with durable response out to eight weeks; open-label durability data expected in Q3.

• Second dosing in the open-label extension aims to confirm durability and potentially increase remission rates, targeting 40–50% with repeat dosing.

• Additional analyses include anxiety, anhedonia, and disability using GAD-7 and SHAPS scales, with interest in subgroup responses.

• No further extension for the current trial; phase 3 will include an open-label extension over a year.

• 8 mg dose of BPL-003 advanced due to similar efficacy but better safety compared to 12 mg; higher dose had more adverse events.

Regulatory and trial design considerations

• End of phase 2 meeting with FDA to be requested this quarter; breakthrough therapy designation application prepared.

• Phase 3 design will likely use a true placebo and a middle psychedelic dose to address unblinding and expectancy effects.

• Study initiation for phase 3 targeted for early next year, with patient enrollment around mid-year; timelines depend on regulatory alignment.

• Evolving FDA guidance emphasizes abuse potential, durability of effect, and openness to dosing with underlying antidepressants.

• Safety monitoring requirements and professional guidelines are under discussion, with hopes for data-driven adjustments.

Pipeline and operational updates

• VLS-01, an oral transmucosal DMT, is in phase 2 for TRD; 120 mg dose selected for better tolerability.

• Phase 2 design for VLS-01 includes two doses two weeks apart, with a 12-week follow-up; incremental benefit from second dose anticipated.

• Recruitment for VLS-01 is slower due to limited site capacity and complex Schedule I requirements.

• EMP-01 is being developed for social anxiety disorder, targeting a large, underserved market with unique compound properties.