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COMPASS Pathways (CMPS) investor relations material

COMPASS Pathways Canaccord Genuity’s 45th Annual Growth Conference summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Canaccord Genuity’s 45th Annual Growth Conference summary12 Aug, 2025

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.

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Q3 202530 Oct, 2025
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Frequently asked questions

COMPASS Pathways Plc is a mental health care company developing psychedelic-based therapies for the treatment of mental health disorders. The company focuses on clinical research and development of psilocybin-assisted therapies for conditions such as treatment-resistant depression. The company is headquartered in London, United Kingdom, and its shares are listed on the NASDAQ.

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