Compass Pathways PLC
NASDAQ:CMPS
Compass Pathways PLC
Compass Pathways Plc functions as an investment holding company. The company is headquartered in Altrincham, Cheshire and currently employs 116 full-time employees. The company went IPO on 2020-09-18. The firm is focused on treatment-resistant depression (TRD). The company is developing COMP360, a psilocybin formulation that includes its pharmaceutical-grade polymorphic crystalline psilocybin, optimized for stability and purity. Its COMP360 psilocybin therapy comprises administration of its COMP360 with psychological support from specially trained therapists with specific professional and educational qualifications. The psilocybin administration session lasts approximately six to eight hours, with patients supported by therapists in a non-directive manner. Psilocybin administration sessions are preceded by preparation sessions, in which patients are given a thorough orientation, and followed by integration sessions to help patients process the range of emotional and physical experiences facilitated by COMP360 administration.
Compass Pathways Plc functions as an investment holding company. The company is headquartered in Altrincham, Cheshire and currently employs 116 full-time employees. The company went IPO on 2020-09-18. The firm is focused on treatment-resistant depression (TRD). The company is developing COMP360, a psilocybin formulation that includes its pharmaceutical-grade polymorphic crystalline psilocybin, optimized for stability and purity. Its COMP360 psilocybin therapy comprises administration of its COMP360 with psychological support from specially trained therapists with specific professional and educational qualifications. The psilocybin administration session lasts approximately six to eight hours, with patients supported by therapists in a non-directive manner. Psilocybin administration sessions are preceded by preparation sessions, in which patients are given a thorough orientation, and followed by integration sessions to help patients process the range of emotional and physical experiences facilitated by COMP360 administration.
Accelerated Launch: COMPASS Pathways is moving up its potential launch timeline by 9 to 12 months, mainly due to faster trial enrollment and supportive FDA interactions.
Clinical Progress: The first Phase III trial (COMP005) met its primary endpoint, and enrollment in the second Phase III trial (COMP006) is now complete.
Upcoming Data: 9-week data from COMP006 and 26-week data from COMP005 will be disclosed together in Q1, with 26-week data from COMP006 expected in early Q3 next year.
NDA Filing: The company anticipates beginning a rolling NDA submission, pending key trial readouts, and has added regulatory resources to support the accelerated process.
Commercial Readiness: Commercial preparations are being pulled forward, with a focus on marketing, sales force planning, and payer engagement.
Cash Position: The company ended September with $186 million in cash, maintaining its runway into 2027.
PTSD Program: Design for a late-stage PTSD trial is finalized, with first patient in expected in the first quarter of next year.
