COMPASS Pathways (CMPS) investor relations material

Regulatory and commercialization updates

• NDA filing for COMP360 is on track for completion in Q4, with rolling submissions already underway and active FDA review in progress.

• A national priority review voucher and Breakthrough Therapy designation may expedite FDA review, with a potential PDUFA date targeted for early 2027.

• DEA rescheduling is required post-approval, with timelines influenced by recent executive orders encouraging expedited review.

• Launch is anticipated in the first half of 2027, with preparations to be launch-ready by the end of this year.

• Active engagement with payers is ongoing to ensure reimbursement and access upon launch.

Product differentiation and clinical impact

• COMP360 offers rapid, durable effects for treatment-resistant depression, with significant improvement seen after a single dose and durability lasting at least six months.

• Safety profile is favorable, with most adverse events being mild, transient, and occurring on the day of administration.

• The product is positioned as transformational for both patients and the industry, with a focus on scientific rigor and patient safety.

• Launch strategy emphasizes education and support for prescribers and sites to ensure a positive experience and minimize barriers.

• The patient experience involves a largely silent, six-hour monitored session, contrasting with more frequent, shorter visits required by alternatives like SPRAVATO.

Market landscape and commercial strategy

• The prescriber base is highly concentrated, with fewer than 10,000 current SPRAVATO prescribers, allowing targeted outreach and support.

• Big pharma interest in the space is seen as validation, but the company expects several years on market before major competitors enter.

• Pricing strategy is being developed, with payers showing strong interest due to the product's rapid and durable efficacy in a difficult-to-treat population.

• The launch will leverage existing infrastructure built for SPRAVATO, enabling faster adoption and scaling.

• Initial ramp is expected to be slow to ensure quality experiences, but a rapid acceleration is anticipated once barriers are removed and positive outcomes are established.