COMPASS Pathways (CMPS) investor relations material

Clinical development and regulatory progress

• Two phase III trials for COMP360 in treatment-resistant depression (TRD) showed highly significant results, with NDA filing completion expected in Q4 2026 and potential launch in H1 2027.

• COMP360 received Breakthrough Therapy designation and a Priority Review Voucher, enabling a rolling submission and potentially expedited FDA review.

• DEA and state rescheduling processes are being prepared to enable timely market entry after FDA approval, with launch timing expected in the first half of 2027.

• A late-stage trial for PTSD is underway, designed as a single registrational study, leveraging existing infrastructure and showing promising early efficacy signals.

Product profile, dosing, and safety

• COMP360 is expected to have a broad label for TRD, with dosing likely two to four times per year, based on clinical trial data.

• The product offers a differentiated profile compared to SPRAVATO, with fewer required administrations and greater durability of effect.

• REMS requirements are anticipated to be similar to SPRAVATO, but with a longer monitoring period (six hours vs. two hours).

• Safety data support both monotherapy and adjunctive use with SSRIs, with label language expected to be agnostic regarding combination therapy.

Commercial launch and market preparation

• Approximately 8,000 clinics are currently certified for multi-hour treatments, with rapid growth expected by launch.

• Sales force hiring has begun, contingent on approval, to cover all certified sites and referring physicians.

• Strategic collaborations and medical science liaison teams have engaged extensively with clinics to prepare for implementation.

• New CPT codes specific to psychedelic treatments have been secured, and a J-code application is planned to optimize reimbursement and buy-and-bill economics.