Compass Pathways Stock Earnings Reports

COMPASS Pathways announced a potential 9–12 month acceleration of its launch plans for COMP360 in treatment-resistant depression (TRD) driven by strong execution in the Phase III COMP006 trial and constructive FDA interactions supporting a potential rolling NDA submission. Key operational points: COMP005 met its primary endpoint with a highly statistically significant and clinically meaningful result; COMP006 enrollment is complete and management plans to unblind and disclose Part A 9‑week data alongside COMP005 26‑week data in Q1 (likely late Q1), with COMP006 26‑week data expected in early Q3 next year—anticipated to be the final gating item for the NDA. The company is pulling forward commercialization readiness (market access, sales/org planning, IT, payer engagement) while continuing regulatory and CMC work. They finalized a late‑stage PTSD protocol and expect to start that program next year. Financially, cash and equivalents were $186M at 9/30, debt under the Hercules facility was $31.3M, cash used in Q3 was $35M, and management expects 2025 net operating cash burn of $120M–$145M (including a UK R&D tax credit timing uncertainty), with runway into 2027. Management reiterated supportive FDA dialogue, readiness for potential advisory committee review, and confidence that sites currently delivering SPRAVATO can generally administer COMP360 with modest incremental changes.