COMPASS Pathways Reports Q1 2023: Financials, Commercial Groundwork And Ongoing Phase 3 Trials

Mental healthcare biotech company advancing psilocybin therapy COMPASS Pathways plc CMPS reported its financial results for the first quarter 2023 ended March 31, 2023 and updated on recent business and clinical progresses.

In numbers:

• Cash and cash equivalents totaled $117.1 million as of March 31, 2023 compared to $143.2 million as of 31 Dec. 2022.

• Net loss was $24.2 million ($0.57 loss per share) compared to $21.2 million ($0.50 loss per share) in the first quarter of 2022.

• R&D expenses were $19.0 million compared to $15.4 million in the same period in 2022.

• G&A expenses were $12.8 million compared to $10.1 million in the same period in 2022.

During the second quarter so far, COMPASS raised an extra $26.9 million net cash through ATM facility to date. The company further announced an expected $22-$30 million net cash expense for operating activities for the second quarter, and a $85-$110 million yearly operating expense.

See also: COMPASS Pathways Shares Q4 & Year-End 2022 Financials, Advances Phase 3 Psilocybin Trials

CEO Kabir Nath says COMPASS’ two Phase 3 multi-site psilocybin trials for Treatment-Resistant Depression (TRD) are currently underway and on track, “indicating that with the necessary approvals and licenses in place, these sites can now focus completely on training and recruitment.”

Specifically, trial 1 (or COMP 005) is set to provide a single-dose monotherapy to some 255 participants, with topline data expected in the summer of 2024; and trial 2 (or COMP 006) is a fixed repeat-dose monotherapy assessed in 568 subjects, of which topline data is expected by mid-2025.

Nath also mentioned the company’s progress in laying the commercial groundwork for COMP360 through AMA’s approval of a CPT III code describing the support services required in psychedelic administration.

Additionally, COMPASS has continued to investigate COMP360 psilocybin therapy in preclinical and clinical trials, including those on anorexia-nervosa and PTSD, during this first quarter of 2023.

“It has been a quarter of steady, strong progress, including productive, ongoing dialogue about the design of our pivotal trials with FDA,” Nath concluded.

Photo: Benzinga edit with photo by anaterate and sergeitokmakov on Pixabay.