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Atai Life Sciences (ATAI) investor relations material

Atai Life Sciences TD Cowen's 5th Annual Novel Mechanisms in Neuropsychiatry & Epilepsy Summit summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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TD Cowen's 5th Annual Novel Mechanisms in Neuropsychiatry & Epilepsy Summit summary17 Sep, 2025

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.

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Next Atai Life Sciences earnings date

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Q3 202514 Nov, 2025
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Frequently asked questions

Atai Life Sciences N.V. is a clinical-stage biopharmaceutical company focusing on the acquisition, incubation, and development of therapeutics aimed at treating a range of mental health disorders such as depression, anxiety, addiction, among others. The company is developing a decentralized platform approach to expedite the development of effective mental health treatments. The company is headquartered in Berlin, Germany, and its shares are listed on the NASDAQ.

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