COMPASS Pathways (CMPS) KOL Event summary

Introduction and agenda

• Provided updates on COMP360 programs for PTSD and TRD, including pivotal trial designs, commercial readiness, and FDA acceptance of the IND for PTSD, enabling a late-stage clinical trial launch.

• Announced completion of enrollment in the second phase III TRD trial and accelerated launch timelines, with commercial preparations for TRD advancing toward year-end readiness.

• Outlined agenda: clinical rationale, trial design, commercial preparedness, integration into care networks, fireside chat, and Q&A.

KOL background and credentials

• Presenters included company leadership and external experts such as Dr. Gary Small, Dr. Geoffrey Grammer, Myriam Barthes, and Dimitri Cavathas, representing academic, clinical, and care delivery backgrounds.

Market insights and analysis

• PTSD affects over 13 million adults in the U.S. annually, with a $230 billion economic burden, limited treatment innovation, and only two FDA-approved medications.

• TRD impacts about 4 million U.S. adults, with high comorbidity, mortality, and societal costs, and only two approved medicines.

• Existing TRD treatments like Spravato are effective but operationally burdensome and underutilized; interventional psychiatry infrastructure is expanding.