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

Clinical program updates

• Lead candidate COMP360, a synthetic psilocybin, is in phase III trials for treatment-resistant depression (TRD), with top-line six-week data from COMP005 expected next quarter and 26-week data in the second half of 2026.

• Phase III trials are designed to meet FDA guidance, including placebo control, durability, and 52-week safety data, with options for retreatment and open-label dosing at week 26.

• Limited top-line data disclosure will include primary endpoint results and a high-level safety summary, with specific attention to suicidality.

• Rigorous site and patient selection processes are in place to minimize professional patient and psychedelic seeker bias, using validated medical and pharmacy records.

• Psychological support in trials is standardized, non-directive, and distinct from psychotherapy, focusing on patient safety and education rather than therapeutic intervention.

Market landscape and commercial preparation

• TRD represents a significant unmet need, with only two approved drugs and millions affected; COMP360 aims to address this gap and potentially expand to broader populations.

• Active efforts are underway for state-level rescheduling to ensure timely market access post-approval, with legislative work already started.

• Commercial network development includes collaborations with interventional psychiatry networks and hospital systems, representing several hundred sites, with plans to expand as needed.

• Existing SPRAVATO sites, numbering in the hundreds, are considered suitable for COMP360 delivery due to their infrastructure and experience with TRD treatments.

PTSD program and future directions

• A late-stage program for PTSD is in design, following promising phase II open-label results and strong patient-reported outcomes, especially regarding symptom relief without trauma revisiting.

• PTSD is highly prevalent, chronic, and comorbid with depression, with patients often motivated for new treatment options.

• Future studies will likely involve VA participation and address the complex needs of this population.