COMPASS Pathways (CMPS) investor relations material

Clinical development and data insights

• Two phase III trials in treatment-resistant depression showed highly significant efficacy and strong safety, with six-week and six-month data available; six-month data for the second trial expected early Q3.

• COMP360 demonstrated rapid efficacy (less than 24 hours) and durable response up to six months after one or two treatments, outperforming current standard SPRAVATO.

• Second dose in COMP006 increased clinically meaningful response rates from 25% to nearly 40% compared to single dose in COMP005.

• Ongoing studies will inform optimal dosing regimens and support payer and physician guidance; 52-week follow-up data for both trials will be available during the FDA review process.

Regulatory and commercialization strategy

• Rolling NDA submission and review process with the FDA is underway, supported by stable and collaborative interactions with the psychiatric division.

• Breakthrough Therapy designation and Commissioner's Priority Review Voucher (CNPV) could accelerate review timelines to as little as 1–2 months.

• DEA rescheduling expected within 90 days post-approval, with 90% of the U.S. population in states planning to reschedule within 30 days of federal action.

• Commercial readiness is prioritized, with sales force training and site preparation planned during the interim between approval and launch.

Market landscape and site capacity

• Over 4,000 new sites capable of delivering multi-hour in-office treatments came online in 2025, reflecting rapid infrastructure growth.

• Sites are enthusiastic and have significant unused capacity, having built infrastructure in anticipation of new treatments like COMP360.

• REMS requirements are expected to mirror SPRAVATO, focusing on safe use and site certification without restricting medical practice.

• Economics favor further expansion of treatment centers if demand increases.