COMPASS Pathways (CMPS) H.C. Wainwright 28th Annual Global Investment Conference summary

Clinical development and trial results

• COMP360, a synthetic psilocybin, demonstrated rapid onset and sustained durability in two phase III trials for treatment-resistant depression (TRD), with significant improvement seen as early as the next day and durability lasting up to 26 weeks after one or two doses.

• Open-label data extended durability findings to 12 months, with additional dosing at 26 weeks maintaining efficacy through one year.

• COMP360 requires only one to four treatments per year, a significant reduction compared to existing therapies like SPRAVATO, which may require 25-50 annual administrations.

• The phase III trials included nearly 900 patients and were blinded through 26 weeks, surpassing typical standards in psychiatric studies.

• A late-stage PTSD program is underway, following promising phase II results showing high remission rates and robust safety in an open-label study.

Regulatory and commercialization strategy

• Rolling NDA submission is nearly complete, with the clinical module to be finalized in Q4 2026 and anticipated approval in 2027.

• The National Priority Voucher and an executive order are expected to expedite FDA review and DEA rescheduling, potentially shortening timelines to approval and launch.

• Most states are prepared to reschedule within 30 days of federal action, covering about 93% of the US population.

• Launch readiness is targeted by year-end 2026, with commercial launch expected in the first half of 2027.

• Existing interventional psychiatry centers are already equipped to deliver COMP360, leveraging infrastructure and staff used for SPRAVATO and TMS.

Reimbursement and market access

• New CPT codes specific to psychedelic administration have been developed to ensure providers are reimbursed for all aspects of treatment, addressing gaps seen with SPRAVATO.

• These codes are currently in Category III and will progress to Category I post-approval, with field teams supporting sites in coding and reimbursement.

• Clinics benefit from longer in-clinic treatments, as new codes allow for hour-by-hour billing, reducing administrative complexity and maximizing revenue.