COMPASS Pathways (CMPS) TD Cowen 45th Annual Healthcare Conference summary

Clinical program updates

• Two pivotal phase III trials for COMP360 in treatment-resistant depression are underway, with six-week primary endpoint data expected next quarter and 26-week data in the second half of 2026.

• The phase II-B study showed about 25% remission after a single dose at 12 weeks, supporting further development.

• Both phase III trials are designed to meet FDA guidance, including 26-week blinded periods and 52-week safety data.

• Limited top-line data disclosure will include the primary endpoint difference and a high-level safety summary, focusing on suicidality if present.

• A late-stage PTSD program is being designed following promising phase II data.

Market landscape and unmet need

• Treatment-resistant depression affects over 3 million in the US, with only two approved drugs, one rarely prescribed and the other being esketamine.

• The current treatment pathway involves multiple lines of pharmacotherapy, with many patients unsatisfied by existing options.

• Esketamine and somatic therapies are increasingly used, highlighting the rise of interventional psychiatry.

Trial design and methodology

• COMP005 is a placebo-controlled study with a 2:1 randomization, while COMP006 uses three active doses and allows for retreatment.

• Both studies run blinded for 26 weeks, with an open-label dose at week 26 to maintain patient retention.

• Strict site selection and patient entry criteria are used to minimize professional patients and psychedelic seekers.

• Prior psychedelic experience is capped at 15% in phase III, with stratification across arms.