COMPASS Pathways (CMPS) investor relations material

Regulatory and clinical development updates

• FDA open to a rolling NDA submission and review for COMP360 in treatment-resistant depression (TRD), with potential submission in late next year and possible launch by year-end, accelerating previous timelines by 9–12 months.

• Expectation of priority review due to breakthrough designation, with potential to beat the PDUFA date.

• Second Phase III study (COMP006) fully enrolled ahead of schedule; primary endpoint data from both Phase III studies to be disclosed in Q1 next year.

• 26-week long-term data from the second study expected in early Q3, serving as the final NDA submission component.

• FDA not requiring efficacy data beyond six weeks but will review safety of redosing and long-term safety data.

Commercialization and market strategy

• Approximately 6,000 Spravato treatment centers exist, growing 35–40% year over year, with only 60,000 patients treated out of 4 million eligible, indicating significant market opportunity.

• Commercial launch will focus on these established centers, leveraging existing staff and infrastructure.

• Foundational commercial efforts include strategic collaborations, MSL education, government affairs, and HEOR work to prepare for payer discussions.

• Accelerated commercial activities will include building marketing, operations, sales force, and market access functions.

• Sales force will be smaller and targeted compared to traditional antidepressant launches, focusing on 5,000–6,000 prescribers and referring physicians.

Product positioning, pricing, and payer access

• COMP360 positioned as requiring fewer treatments than Spravato, potentially reducing patient and caregiver burden.

• Anticipated to be available via specialty pharmacy and buy-and-bill, with favorable payer positioning expected due to limited competition in TRD.

• Pricing analog likely to be Spravato, but focus will be on per patient, per annual cost rather than per dose.