Compass Pathways Shows Robust 2023 Year-End Results, Embraces Clinical Milestones For Psilocybin As Depression Treatment

Compass Pathways CMPS, one of the key players in the psychedelics biotech space, reported its financial results for the fourth quarter of 2023.

Numbers:

• Cash and cash equivalents were $220.2 million by December 31, 2023, up over 50% as compared to the amount held by December 31, 2022 ($143.2 million.)
• Yearly R&D expenses totaled $87.5 million, a 34% increase compared to the yearly 2022 expenses ($65.1 million.)
• Quarterly R&D expenses of $27.1 million, 36% up as compared to the $19.8 million spent during the same period in 2022. 
• Yearly general and administrative (G&A) expenses were $49.4 million, an 8% increase vs. the $45.4 million spent during the same period in 2022. 
• Quarterly G&A expenses of $11.3 million, an 8% decrease from the $12.4 million spent in the same period in 2022.
• Yearly net loss of $118.5 million (or $2.32 loss per share,) an almost 30% YoY increase  compared with the 2022 yearly net loss of $91.5 million (or $2.16 loss per share.)
• Quarterly net loss of $32.5 million (or $0.53 loss per share), a 5% YoY increase compared with $30.9 million (or $0.73 loss per share) during the same period in 2022.
• Long-term debt of $28.8 million by December 31, 2023, vs. $0 million by December 31, 2022.
• Additional $31.4 million net cash raised to date in Q1 2024.

Expected Financials For 2024

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. 

Behind Finances: The Clinical Pipeline

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

Now Read: Psilocybin-Assisted Therapy Achieves Positive Clinical Trial Results For Treating Generalized Anxiety

Tune in to the latest management team's conference call on published earnings.

Photo: Benzinga edit with photo by Pexels.