COMPASS Pathways (CMPS) TD Cowen 46th Annual Health Care Conference summary

Key clinical trial results

• Phase III studies (005 and 006) showed statistically significant MADRS score improvements at all measured time points, with rapid onset and sustained effects up to 26 weeks after administration.

• A second dose provided additional benefit, increasing both the depth and breadth of response, with remission rates rising to 40% in some groups.

• Consistency in primary endpoints and durability of response was observed across multiple trials, including long-term follow-up.

• The 10 mg dose showed inconsistent results and will not be the initial focus for regulatory filing, though it is being explored in PTSD trials.

• Quality of life and patient-reported outcomes will be included in future data releases, with more comprehensive analyses expected in early Q3.

Clinical and commercial implications

• A 25% reduction in MADRS is considered clinically meaningful, translating to significant improvements in patient quality of life.

• Rapid identification of responders within 24 hours is highly differentiated from current TRD treatments, offering hope and potentially life-saving benefits.

• Safety profile is favorable, with a low barrier to trying the treatment due to quick response and minimal safety concerns.

• Existing infrastructure for similar treatments (e.g., SPRAVATO) can be leveraged for administration and monitoring, minimizing operational changes.

• REMS requirements are expected to be similar to SPRAVATO, with licensed healthcare providers on site and standard monitoring protocols.

Regulatory and strategic updates

• Ongoing, collaborative relationship with the FDA, with data submitted on a rolling basis and breakthrough designation accelerating timelines.

• No shortcuts in development; robust trial designs and comprehensive safety data support regulatory filings.

• The company is not prioritizing the Commissioner's voucher due to limited added value given the accelerated review process.

• Real-world evidence post-approval will help refine patient profiles and further inform commercial strategy.

• Conference presentations and additional data releases are planned for later in the year.