Compass Pathways, a leading player in psychedelic-based mental health treatments, has announced a significant delay in the release of data from its Phase 3 trial for COMP360, a psilocybin-based therapy aimed at treating treatment-resistant depression. Alongside this timeline shift, Compass will also lay off 30% of its workforce, including senior management positions, to concentrate resources solely on advancing COMP360.
Initially, the company anticipated data from the first of its Phase 3 trials, dubbed COMP005, by summer 2024. However, logistical challenges, particularly with multiple-dose scheduling, have pushed this deadline to the second quarter of 2025. Compass CEO Kabir Nath highlighted that the complexity of managing psychedelic-naive patients and coordinating therapy sessions at various sites have extended the trial duration beyond earlier expectations.
The delay impacts both of Compass’s key studies. The second trial, COMP006, which features three active arms, will now have results delayed until late 2026. Nath cited concerns over maintaining blinding procedures—a response to recent FDA scrutiny, especially following the agency’s rejection of Lykos Therapeutics’ MDMA therapy. This added layer of caution will require that COMP006 data be held back until all patients complete a 26-week follow-up.
Compass’s shift in priorities has led to a streamlined organizational focus on COMP360. By year’s end, the company will halt all non-COMP360 preclinical projects and is actively exploring options for externalizing its digital health assets. These digital tools were developed to assist in therapist training, patient preparation, and post-therapy integration but will no longer be supported in-house.
The company’s restructuring comes as Compass aims to maximize the runway of its $207 million cash reserves, which it expects to last through at least 2026. Despite these moves to ensure COMP360’s advancement, Compass’s stock price fell 16% in premarket trading, reflecting investor concerns over the prolonged timeline and layoffs.
Compass Pathways, founded with a mission to innovate mental health treatments, is betting heavily on COMP360 to drive future success. As the psychedelic treatment landscape continues to evolve, all eyes will be on Compass to deliver on the promise of psilocybin-based therapy amidst a challenging regulatory and operational environment.
