COMPASS Pathways plc Q1 FY2025 earnings call

• Completed dosing of all participants in Part A of 005 trial, with top line results expected in late June for three key efficacy measures in TRD. • Safety data on 005 trial is reviewed by DSMB, with request for DSMB comment on suicidality. • Phase 3 trial 006 is ongoing globally, on track for 26-week results in H2 2026. • 52-week safety and efficacy data from COMP004 published, showing long-term benefits of COMP360 in TRD. • Strategic collaboration with HealthPort to focus on community-based delivery to underserved patient populations. • Strong financial position with $260M cash and cash equivalents at end of March, expecting to fund operations through 006 26-week data readout. • Working on final design for late-stage clinical program in PTSD.

No specific product segment financial performance details provided in the transcript.

• Awaiting 005 top line results in late June. • Expecting 006 26-week results in the second half of 2026. • Net cash used in operations for 2025 expected to be within $120 million to $145 million range. • Continued work on final design for late-stage clinical program in PTSD.

• Risks described in most recent quarterly report on Form 10-Q and subsequent SEC filings. • Suicidality monitoring and potential signal vs. noise in data interpretation. • Variability in placebo effect and high variability in the psychedelic space. • Potential pharma tariffs and their impact on manufacturing costs.

Q: Can you highlight key takeaways from the 52-week follow-up data on durability and appropriate dose?

A: Guy Goodwin mentioned data isn't definitive but shows 25 mg dose has longer durability in some subgroups, with 25 mg being the preferred dose for Phase 3.

Q: What's the base case for placebo effect in 005 study and how to contextualize effect size?

A: Guy Goodwin stated placebo response is expected due to frequent hospital visits and positive attention, with expectation of over a 3-point difference on MADRS scale being clinically significant.

Q: Thoughts on DSMB commentary on suicidality and background rate in TRD study?

A: Guy Goodwin noted suicidality is a core feature of TRD, FDA not concerned about Phase 3 likelihood, and expectation of no important differences between arms.

Q: Characterize HealthPort collaboration and their involvement in Spravato delivery?

A: Steve Levine said HealthPort is a community clinic serving underserved populations, has experience delivering Spravato, and is motivated to deliver new treatments if approved.

Q: Potential pharma tariffs and manufacturing supply chain?

A: Kabir Nath said product is manufactured in UK, plans to add US manufacturing, and tariffs would be considered in pricing.

Q: Patient profile in COMP006 vs Phase 2b?

A: Guy Goodwin said recruitment criteria are the same, so patient profiles are similar.

Q: Optimal time frame for suicidality not attributable to COMP360 and FDA interactions on psychedelics?

A: Guy Goodwin said will assess data as it comes, and no changes in day-to-day FDA interactions noted.

Q: Interpretation of 52-week study in TRD program and use of antidepressants in trials?

A: Steve Levine said durability up to 6 weeks is groundbreaking, and antidepressants are likely to be co-administered in practice.