COMPASS Pathways (CMPS) investor relations material

Clinical data and study outcomes

• Phase III COMP005 study showed that additional doses of COMP360 provided incremental and durable improvement in treatment-resistant depression, with benefits sustained up to one year.

• Consistent efficacy and safety profiles were observed across both COMP005 and COMP006 studies, with rapid and clinically meaningful reductions in MADRS scores.

• Multiple doses (up to three) demonstrated durable responses out to 52 weeks, with immediate benefit for responders.

Regulatory and launch timeline

• NDA filing is on track for completion in Q4, with all necessary clinical data in-house and final integrated safety summaries being prepared.

• Approval is anticipated in the first half of the following year, though timelines may vary due to limited regulatory precedents and DEA rescheduling requirements.

• Federal DEA rescheduling typically takes up to 90 days post-approval, with 93% of the US population in states that will reschedule within 30 days.

Commercial readiness and site preparation

• About 80% of SPRAVATO volume is concentrated in less than 2,000 sites, though over 8,000 interventional psychiatry centers are coming online, expanding rapidly in anticipation of new treatments.

• Sites REMS-certified for SPRAVATO are generally prepared for COMP360, with sales and field reimbursement teams being hired contingent on approval.

• Major commercial geographies, including top 30 states, are trigger states for rapid rescheduling.