COMPASS Pathways (CMPS) Investor presentation summary

Transforming mental health care with COMP360

• COMP360 demonstrated consistent, robust efficacy in three late-stage trials for treatment-resistant depression (TRD), with over 1,000 participants showing statistically significant results and rapid, durable symptom reduction up to 26 weeks.

• The drug targets large, underserved markets: approximately 4 million TRD and 13 million PTSD patients in the U.S.

• COMP360 is positioned for an accelerated regulatory path, with rolling NDA submission underway, FDA National Priority Review Voucher granted, and anticipated launch in the first half of 2027.

• Commercial readiness includes established site-of-care infrastructure, payer discussions, and provider training to support launch.

• The company holds a robust patent portfolio, with exclusivity expected beyond 2038, and has a seasoned management team with deep industry experience.

Clinical efficacy and safety in TRD

• Phase 3 trials (COMP005 and COMP006) showed rapid onset of action, with significant MADRS score improvements as early as the day after dosing and sustained effects through 26 weeks.

• 25–39% of participants achieved clinically meaningful reductions in depression at week 6, with many maintaining response or achieving remission after additional dosing.

• COMP360 was generally well-tolerated; most adverse events were transient and occurred on the day of administration, with serious adverse events low and similar across dose groups.

• The trials included diverse patient populations with chronic, severe depression and multiple failed prior treatments.

• Duration of current depressive episode was the strongest predictor of non-response in TRD.

Commercial and operational readiness

• COMP360 prescribing and dosing are designed to integrate into current clinical practice, with administration at certified centers and reimbursement pathways established.

• Over 7,500 interventional psychiatry clinics in the U.S. are preparing to offer COMP360, leveraging established practice patterns and infrastructure.

• Strategic collaborations with major health systems and providers are informing launch strategies and patient care pathways.

• Advanced commercial launch preparations are underway, including payer engagement, distribution, and patient support mechanisms.