AtaiBeckley (ATAI) 25th Annual Needham Virtual Healthcare Conference summary

Company overview and strategic priorities

• Focused on late-stage clinical development of short-duration psychedelic-based neuroplastogens for mental health indications with large unmet needs.

• Pipeline includes BPL-003 (intranasal 5-MeO-DMT, entering phase III for TRD), VLS-01 (oral DMT, phase II for TRD), and EMP-01 (oral R-MDMA, positive phase I/II in social anxiety disorder).

• Merger of atai and Beckley in late 2023 brought BPL-003 into the portfolio and redomiciled the company to the US.

Industry landscape and recent developments

• Multiple late-stage data readouts in psychedelics have increased credibility and investor interest in the sector.

• Major acquisitions by AbbVie and Otsuka signal strategic validation of psychedelic therapies.

• Johnson & Johnson’s Spravato has surpassed $2 billion in annual sales, highlighting commercial potential.

Differentiation and clinical data for BPL-003

• BPL-003 offers rapid onset and short duration (psychedelic effects resolve in 90 minutes), fitting into a 2-hour clinic visit, unlike LSD or psilocybin which require all-day monitoring.

• Phase II data showed a 6.2-point improvement at 4 weeks and sustained benefit at 8 weeks, with over 80% of patients ready for discharge at 2 hours.

• Durability of effect is robust, with many patients maintaining remission for several months and flexible redosing options (8-12 weeks) planned for phase III.