COMPASS Pathways (CMPS) investor relations material

Regulatory and industry landscape

• Political and regulatory support for psychedelic treatments is seen as a tailwind, with leadership at HHS, FDA, and VA expressing urgency to address unmet mental health needs, especially in treatment-resistant depression and PTSD.

• FDA remains engaged and responsive, with ongoing dialogue and breakthrough therapy designation facilitating frequent interactions.

• The company has applied for the commissioner's priority voucher and scheduled a Type B meeting with the FDA this quarter to discuss data and potential accelerated filing scenarios.

• No significant changes in the FDA team composition; engagement and support remain strong.

Clinical trial progress and data insights

• Phase 2b study in treatment-resistant depression showed robust, statistically significant results at both three and six weeks, with a 25mg dose outperforming an active comparator.

• Recent top-line data from the first phase 3 trial (COM005) demonstrated a clinically meaningful and statistically significant separation from placebo at week six after a single administration.

• The DSMB issued a clean safety statement for patients in both phase 3 trials, with no new safety signals or imbalances.

• The upcoming 26-week dataset from part B of the phase 3 trial will provide comprehensive efficacy and safety data, including durability and retreatment effects.

Market positioning and commercialization

• Major biopharma interest in the psychedelic space is growing, with ongoing conversations and validation from recent industry activity.

• Confident in ability to commercialize in the US due to unique skill sets and experience; may seek partners for ex-US markets.

• Less frequent administration compared to SPRAVATO could reduce patient and caregiver burden and potentially demonstrate greater value.

• Interventional psychiatry infrastructure has scaled, with over 6,000 sites delivering SPRAVATO, supporting future commercial scale.