COMPASS Pathways (CMPS) investor relations material

Clinical development and trial updates

• Enrollment for the second phase III trial (006) is complete, marking a major milestone and locking in data timelines.

• Detailed data from both phase III trials (005 and 006) will be disclosed in Q1 next year, with final 26-week data from 006 expected in early Q3.

• Phase III trials are placebo-controlled and designed to meet FDA safety benchmarks, with clean safety profiles reported by the DSMB.

• Durability and efficacy data suggest patients may require two to five treatments per year, with ongoing adjunctive data collection for SSRI use.

• Retreatment criteria are based on MADRS scores, with expectations for a broad label allowing episodic retreatment.

Regulatory and submission strategy

• Positive and collaborative FDA interactions have enabled a potential rolling submission and accelerated review.

• Disclosure of part A of the 006 trial is being pulled forward to facilitate the rolling submission.

• Accelerated timelines could bring launch forward by 9-12 months, with all commercial preparations being expedited.

Commercial readiness and scalability

• Commercial efforts are ramping up, focusing on high-potential prescribers and leveraging existing Spravato infrastructure.

• New CPT codes for psychedelic treatments allow for more comprehensive billing, making delivery economically favorable for sites.

• Initial delivery will likely be one patient per room, with future efficiencies expected as sites gain experience.

• No therapy is required for administration; monitoring and support can be provided by any healthcare professional.

• There is a concentrated prescriber base, with 80% of Spravato volume coming from less than 1,000 prescribers.