As Psilocybin Trials Face Delays, Compass Pathways (CMPS) Cuts Workforce To Conserve Cash

Compass Pathways CMPS has announced delays for two key Phase 3 clinical trials involving its psilocybin program, widely seen as a leader in the psychedelic drug development space. As Endpoint News reported, the unexpected timeline shifts, unveiled in the company's third-quarter earnings report, have led to a 30% reduction in workforce, affecting 55 positions, including some senior management roles. 

Extended Timelines For Key Trials

Compass originally anticipated releasing data for its COMP005 Phase 3 trial by the fourth quarter of this year; however, this has now been postponed to the second quarter of 2025. COMP006, a second Phase 3 trial examining fixed psilocybin doses, has also been delayed by about a year, now targeting the second half of 2026 for data readouts.

CEO Kabir Nath acknowledged the delays stemmed from unexpected complexities in trial logistics, notably arranging therapist participation and scheduling multiple dosing sessions for patients. “We just underestimated…the complexity and the time it would take to get it done," Nath admitted. R&D chief Mike Gold has been working on site at various COMP005 trial locations to address operational bottlenecks.

Regulatory Considerations Impact Trial Adjustments

As Nath explained, the reason behind the COMP006 delay was to maintain trial blinding integrity, a critical factor in psychedelic research. Unlike typical trials, participants in psychedelic studies can often guess whether they received the active treatment, a phenomenon known as “functional unblinding.” Feedback from regulators following Lykos Therapeutics' recent MDMA trials highlighted this issue, leading Compass to tighten blinding controls to ensure robust data.

Also Read: FDA Public Meeting Reveals Federal Support For Psychedelics In PTSD Care

Financial Restructuring And Workforce Reduction

To manage cash flow and ensure funding through the COMP005 milestone, Compass has laid off 30% of its workforce, including top executives such as CCO Christopher Williams and CLO Matthew Owens. Preclinical research initiatives, including the development of a compound library, have also been put on hold. "We're going to put [the compound library] on the shelf," Nath commented, as the company refocuses on its Phase 3 efforts.

CFO Teri Loxam emphasized that the restructuring aims to preserve, rather than extend, cash reserves, allowing Compass to maintain operations up to the 2026 target. With $207 million in cash on hand, the company hopes the COMP005 results could catalyze new funding or partnership opportunities.

The workforce reduction will help focus resources on the COMP360 program, halting non-COMP360 preclinical efforts and exploring externalization for digital health tools.

"Our top priority is ensuring the success of our COMP360 program for treatment-resistant depression. We remain confident in its potential effectiveness. Due to shifts in our phase 3 program timeline, we are reducing our workforce by about 30% and exiting non-essential activities to concentrate on completing trials and regulatory processes," Nath stated.

Aiming For Scaled Commercial Application

Looking toward potential commercialization, Nath and Loxam addressed the challenges posed by the logistical requirements of COMP005, asserting that these should not hinder psilocybin’s broader uptake if approved. They anticipate that licensed psychiatric nurses or nurse practitioners could manage the administration of psilocybin, contrasting with Lykos' MDMA-assisted therapy model, which requires more intensive therapeutic involvement. Compass sees these healthcare professionals as providing “psychological support” rather than therapy, which they believe could streamline commercial scalability.

As Compass Pathways pushes forward, the delay in pivotal readouts and financial adjustments may set a cautious tone for the psychedelic therapeutics industry, where regulatory and logistical challenges remain significant hurdles for drug developers. Compass shares traded 23.02% lower at $4.76 per share at the moment of this publication early afternoon on Thursday.

Cover image made with AI