Compass Pathways keeps plugging away with its psilocybin study trials

Compass Pathways plc (Nasdaq: CMPS) reported its financial results for the first quarter of 2024 ending in March with no revenue yet to report. The net loss for the quarter was $35.2 million, or $0.55 loss per share versus last year’s $24.2 million, or $0.57 loss per share for the same period.

Financial update

Research and development expenses increased to $24.9 million over last year’s $19 million in 2023. The increase was expected as the company progressed with its COMP360 phase 3 clinical trials, and increased personnel expenses due to increased R&D headcount. Similarly, general and administrative expenses inched up to $13.7 million over last year’s $12.8 million.

Looking at the balance sheet, cash and cash equivalents were $262.9 million versus $220.2 million at the end of 2023. Compass raised an additional $63.5 million in the first quarter through ATM facility and proceeds from the exercise of warrants.

The company said it will have enough cash to get it to 2026. Compass also said it was expecting to spend between $32 million to $38 million in the second quarter. The full-year 2024 net cash used in operating activities is expected to be in the range of $110 million to $130 million and assumes the 2023 R&D tax credit is received in the fourth quarter of 2024.

The company’s long-term debt was $29.1 million as of March 31, 2024, compared with $28.8 million as of December 31, 2023.

COMP360 update

CEO Kabir Nath said, “We were pleased to see the positive results from the phase 2 PTSD study, a condition with significant unmet need and limited therapeutic options for the people who live with it. PTSD is a logical extension for COMP360 psilocybin treatment as there is significant overlap in patients living with treatment-resistant depression and PTSD. These strong data enable us to explore the optimal path forward to advance clinical development in PTSD alongside our phase 3 pivotal program in TRD, which is on track for initial data this year. We also continue to prepare for commercialization of COMP360 in TRD if approved by the FDA and have established collaborations with important mental health providers in the US to investigate models for the delivery of COMP360 psilocybin treatment at scale in diverse care settings.”

Compass reported that the Phase 3 program for drug-resistant depression is ongoing and composed of two pivotal trials. The pivotal trial 1 (COMP005) is a single-dose monotherapy with top-line data expected in the fourth quarter of 2024. The pivotal trial 2 (COMP006) is a fixed repeat dose monotherapy, and top-line data is expected in mid-2025.

Compass also stated that it was getting early positive results for the treatment of post-traumatic stress disorder with COMP360. It is exploring a path forward for that use.

Management changes

Compass also told investors that Chief Development Officer Trevor Mill will be leaving the company. He led the development of the COMP360 program in TRD, launched programs in PTSD and anorexia nervosa, and was instrumental in guiding the exploration of additional early pipeline opportunities.

It seems he will be replaced with Michael Gold, MD, who will join Compass as Chief Research and Development Officer, effective May 20, 2024. Gold will work with Guy Goodwin, Compass’s Chief Medical Officer, to continue developing COMP360 in TRD and other indications, and to explore and advance other potential pipeline opportunities.

Compass has seen a shift in its management teams. As recently as March, its co-founders, George Goldsmith and Ekaterina Malievskaia, resigned from the company’s board of directors. They co-founded the company in 2016.

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