AtaiBeckley (ATAI) Canaccord Genuity 44th Annual Growth Conference & Private Company Showcase 2024 summary

Pipeline overview and clinical development

• Seven assets in clinical development, targeting cognitive impairment in schizophrenia, treatment-resistant depression, social anxiety disorder, and opioid use disorder.

• BPL-003 for treatment-resistant depression is completing enrollment by year-end, with top-line data guidance to follow.

• VLS-01, an oral transmucosal DMT film, showed promising phase I data; phase II top-line results expected by end of next year.

• EMP-01 (R-MDMA) is being developed for chronic social anxiety disorder, with trials using the LSAS as a primary endpoint and exploring durability over 12 weeks.

• RL-007 targets cognitive impairment in schizophrenia, with phase IIb data expected mid-2025; even small improvements are considered meaningful.

Regulatory and industry insights

• Recent FDA feedback on Lykos' MDMA program highlighted the need for traditional phase III trials and standardized therapy approaches.

• SPRAVATO's approval is seen as a more relevant precedent for psychedelic-adjacent compounds.

• Dose dependence and durability of response are key to addressing functional unblinding in psychedelic trials.

• Patient and therapist unblinding, as well as trial design and safety data collection, are critical regulatory considerations.

Strategic and financial direction

• Holds a strategic, though reduced, stake in COMPASS, with ongoing reassessment based on clinical data.

• Pipeline has been simplified, focusing on a smaller set of core assets and clearer business models.

• Commercialization strategy remains flexible: RL-007 likely to be partnered post-proof of concept, while psychedelic assets could leverage existing clinical infrastructure for direct commercialization.

• Open to partnerships or acquisition interest, especially as the mental health treatment landscape evolves.