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Compass Pathways (NASDAQ:CMPS), one of the key players in the psychedelics biotech space, reported its financial results for the fourth quarter of 2023.
Numbers:
With Teri Loxam as the new CFO starting March 1, the Compass team is reportedly getting ready for commercialization.
"[We] have commenced a number of collaborations with mental health providers in the U.S. to understand the patient care experience and to investigate models for the delivery of scalable COMP360 psilocybin treatment within various care settings, if approved by the FDA," said CEO Nath.
Insofar, the company has signed for research collaborations with Greenbrook TMS and Hackensack Meridian Health toward exploring and developing potential commercial delivery templates for its psilocybin treatment, should it be federally approved.
The latest financial report states that the cash position by Dec. 31, 2023 paired with the net cash raised to date in Q4 2024 "is expected to be sufficient to fund operating expenses and capital expenditure requirements into late 2025."
For upcoming Q1 2024 results, Compass expects the quarterly net cash used in operating activities to be between $17 million to $23 million and full-year 2024 within the $110 million to $130 million range.
Headquartered in London and with offices in New York and San Francisco, Compass is a mental healthcare company pioneering the development of a new model of psilocybin treatment consisting of a proprietary formulation of synthetic psilocybin ("COMP360") administered in conjunction with psychological support.
COMP360 has received the Breakthrough Therapy designation by the FDA, as well as the Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD.)
The company began conducting its Phase 3 clinical program of psilocybin treatment in TRD in 2023. "The largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted" is composed of two pivotal trials with an integrated, long-term outcomes component to inform about the duration of response as well as the potential effect of retreatment.
Trial 1 (COMP 005) is a single-dose monotherapy administered to 255 patients with TRD. "Some enrollment delays" have resulted in "a slight delay to our guidance for that trial," said CEO Kabir Nath. Topline results for this study are expected in Q4 2024.
Meanwhile, Trial 2 (COMP 006) is a fixed repeat-dose monotherapy administered in 568 patients with TRD. For this significantly large study, topline data is expected by mid-2025
Compass is also conducting Phase 2 clinical studies of psilocybin treatment for anorexia nervosa. The company has recently shared solid results of the COMP360 treatment in bipolar II depression, and will share a full data set from its Phase 2 study on psilocybin for PTSD treatment in Spring 2024 following an initial safety data readout in late 2023
Tune in to the latest management team's conference call on published earnings.
Photo: Benzinga edit with photo by Pexels.
Posted In: CMPS