AtaiBeckley (ATAI) investor relations material

Pipeline overview and clinical progress

• Three advanced assets target mental health: BPL-003 (intranasal 5-MeO-DMT), VLS-01 (oral DMT), and EMP-01 (R-MDMA).

• BPL-003 showed a 6.2-point MADRS improvement over placebo in phase IIb for treatment-resistant depression, with durable effects and high remission rates after two doses over 16 weeks.

• VLS-01 is in phase IIb for depression, with results expected in the second half of the year; it uses an oral thin film for rapid, short-duration effects.

• EMP-01, an R-isomer of MDMA, demonstrated promising behavioral changes in social anxiety disorder in a phase IIa exploratory study.

• All assets are designed for short-duration experiences, aligning with the SPRAVATO clinic model for efficient patient throughput.

Clinical trial design and regulatory alignment

• BPL-003 phase III will include two trials: one with three arms (placebo, 4 mg, 8 mg) and another with two arms (8 mg, placebo), both with primary endpoints at four weeks.

• Open-label extensions allow flexible dosing every 12 weeks, or as soon as eight weeks if symptoms recur.

• VLS-01 phase IIb mirrors the BPL-003 design, with two doses two weeks apart and a four-week primary endpoint.

• EMP-01 phase IIa focused on safety and the Liebowitz Social Anxiety Scale, showing efficacy comparable to SSRIs but with faster behavioral change.

• Regulatory discussions have enabled trial designs that prioritize both efficacy and patient convenience.

Market landscape and commercial strategy

• The interventional psychiatry market is expanding, with SPRAVATO clinics providing a ready infrastructure for new short-duration psychedelic therapies.

• Approximately 5,000–6,000 REMS-certified sites exist in the US, but 600 sites generate 80% of revenue.

• Short-duration drugs allow clinics to treat more patients per day, maximizing reimbursement and operational efficiency.

• The addressable market for treatment-resistant depression is estimated at 3 million, with current therapies reaching only 3%.

• Key opinion leaders indicate strong willingness to switch from SPRAVATO to more convenient, durable alternatives.