COMPASS Pathways (CMPS) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Current status and regulatory progress

• Rolling submission for COMP360 in treatment-resistant depression (TRD) is underway, with FDA review started and completion expected in Q4 2024.

• An executive order led to a National Priority Voucher for accelerated review, targeting a launch in the first half of 2027.

• All required data for NDA submission are in hand, with integration of studies and safety data as the final clinical module steps.

• Late-stage, potentially registrational study in PTSD has commenced, targeting another underserved market.

Clinical data and product differentiation

• COMP360 shows rapid onset, durable effect, and requires fewer doses compared to SPRAVATO, the only other approved TRD drug.

• Open label data from COMP005 informs dosing expectations (2–4 doses/year) and supports commercial planning and payer negotiations.

• Physicians value open label data for real-world analogs, while double-blind data supports scientific rigor.

• Dosing flexibility is built into the anticipated label, allowing physician discretion based on patient response.

Patient experience and site logistics

• COMP360 administration involves a single, multi-hour session with minimal site burden, contrasting with frequent SPRAVATO visits.

• Sites already equipped for SPRAVATO can accommodate COMP360 without additional buildout or staffing.

• Monitoring is typically via CCTV, with multidisciplinary teams circulating; constant in-room presence is not required.

• Emotional responses are expected due to patient population, but no unique psilocybin-specific risks identified.