AtaiBeckley (ATAI) Maxim Group’s 2024 Healthcare Virtual Summit summary

Portfolio and development strategy

• Focused on internally developed assets for depression, anxiety, opioid use disorder, and schizophrenia, with a shift from a broad platform to a more concentrated portfolio.

• Key assets include VLS-01 (oral DMT), EMP-01 (R-MDMA), DMX-1002 (IV ibogaine), BPL-003 (short-acting psychedelic), and RL-007 (for cognitive impairment in schizophrenia).

• BPL-003 trial enrollment to complete late this year, with readout soon after; VLS-01 and EMP-01 phase II trials to start later this year, with mid-next-year readouts.

• RL-007 phase IIb readout expected mid-next year; company maintains a stake in Compass Pathways.

• Portfolio pruning has led to a focus on high-value assets, with Beckley as the only recent addition.

Short-acting psychedelic focus and market rationale

• Emphasis on compounds fitting a two-hour treatment window, aligning with the successful Spravato (esketamine) paradigm.

• Short-acting psychedelics aim to improve patient and doctor logistics, scalability, and throughput compared to current standards.

• Approximately 5,000 centers are equipped for Spravato administration, making the market accessible for smaller companies.

• Products are designed to be easily integrated into existing treatment frameworks.

Clinical trial design and regulatory considerations

• Lessons from recent regulatory setbacks (e.g., Lykos/MAPS MDMA rejection) have informed robust trial designs, including larger sample sizes and established endpoints.

• Strategies to mitigate functional unblinding and ensure data quality are in place, drawing from successful Spravato and Compass Pathways approaches.