AtaiBeckley (ATAI) H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Company overview and differentiation

• Focuses on transforming mental health treatment with a broad pipeline targeting anxiety, depression, substance use disorder, cognitive impairment, and schizophrenia.

• Founded in 2018, motivated by personal experiences with unmet needs in mental health care.

• Pipeline includes programs at various clinical stages, including exposure to phase III through a stake in Compass Pathways.

• Emphasizes innovation in neuropsychiatry, inspired by recent paradigm shifts like Spravato.

Regulatory landscape and industry context

• Recent FDA rejection of MDMA-assisted therapy highlighted the need for standard trial designs and robust efficacy data.

• Guidance for psychedelic therapies aligns with established standards, requiring efficacy independent of non-standardized therapy.

• Companies like Compass and J&J have advanced without specific new guidance, showing a path forward.

Key clinical programs and timelines

• VLS-01: Oral DMT formulation for treatment-resistant depression, phase II trial to enroll 142 patients, readout expected end of next year.

• EMP-01: R-MDMA for social anxiety disorder, phase II trial starting later this year, readout also expected end of next year.

• BPL-003: Intranasal psychedelic in partnership, phase IIb trial to complete enrollment by year-end, with readout a few months later.

• RL-007: Non-psychedelic pro-cognitive compound for cognitive impairment in schizophrenia, phase IIb trial with 234 patients, topline data expected mid-next year.

• IBX-210: Reformulated ibogaine for opioid use disorder, moving into phase I/IIa to address safety and commercial viability.