AtaiBeckley (ATAI) investor relations material

Pipeline overview and clinical progress

• Three late-stage psychedelic compounds in development: BPL-003 (phase III), VLS-01 (phase II-B readout in Q4), and EMP-01 (phase II-A completed).

• BPL-003 is an intranasal, short-duration psychedelic for treatment-resistant depression, with phase III trials (ReConnection-1 and -2) underway.

• VLS-01 targets treatment-resistant depression with an oral thin film formulation, aiming for phase III advancement based on efficacy, durability, and tolerability.

• EMP-01, an R-MDMA oral formulation, showed promising results in social anxiety disorder, with further guidance expected soon.

• Early-stage pipeline includes AI-driven discovery of non-hallucinogenic pro-cognitive therapeutics.

Clinical trial design and regulatory alignment

• BPL-003 phase III program includes two trials: ReConnection-1 (single dose, 12-week follow-up) and ReConnection-2 (two-dose induction, 8-week follow-up), both with open-label extensions.

• Dose selection for BPL-003 based on phase II data: 8 mg chosen for optimal efficacy and tolerability over 12 mg.

• Placebo control and dose-ranging design address functional unblinding and regulatory expectations.

• Primary endpoint at week four aligns with regulatory precedent and minimizes clinical risk.

• FDA alignment achieved on trial design, safety database, and intermittent dosing schedule (every 8–12 weeks).

Safety, tolerability, and adjunctive use

• Safety profile consistent with class effects: mild to moderate nausea, headache, cardiovascular changes, and transient nasal irritation.

• Short duration of BPL-003 limits exposure to adverse effects compared to longer-acting psychedelics.

• No significant difference in efficacy or safety when BPL-003 is used adjunctively with SSRIs/SNRIs; further data expected by year-end.

• Open-label extensions will inform on relapse prevention, maintenance, and retreatment strategies.