Compass Pathways Reports First Quarter 2025 Financial Results and Highlights Progress in Psychedelic Mental Health Therapies
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company pioneering innovative treatments for mental health conditions, today released its financial results for the first quarter ended March 31, 2025. The company also shared significant developments in its ongoing clinical programs, particularly its late-stage efforts in treatment-resistant depression (TRD) and emerging plans in post-traumatic stress disorder (PTSD).
As the mental health crisis continues to escalate globally, Compass Pathways remains committed to advancing evidence-based psychedelic therapies. The company’s lead candidate, COMP360, a proprietary formulation of psilocybin, is currently being evaluated in one of the largest clinical programs ever undertaken for psychedelic-assisted therapy. Compass aims to offer transformative treatment options for individuals with severe psychiatric disorders who have not responded to traditional therapies.
CEO Remarks
Kabir Nath, Chief Executive Officer of Compass Pathways, expressed optimism about the company’s trajectory and clinical milestones. “We eagerly await the upcoming topline six-week data readout from our pivotal COMP360 phase 3 trial, which remains on track for late June,” said Nath. “This data will be the first from our comprehensive phase 3 program in treatment-resistant depression and marks a significant milestone in the development of psychedelic therapies. Our consistent progress underscores Compass’ leadership in this emerging field, which we believe holds great promise as the next generation of mental health care.”
Clinical Program Highlights
COMP360 in Treatment-Resistant Depression (TRD)
The centerpiece of Compass Pathways’ clinical efforts is the COMP360 psilocybin therapy for TRD, a condition affecting millions of patients globally who do not respond adequately to existing antidepressant treatments. The company’s pivotal phase 3 program represents the largest randomized, controlled, double-blind clinical trial involving psilocybin therapy conducted to date.
Key updates from this program include:
- COMP005 Trial (Part A): All participants in part A of the COMP005 trial have completed dosing. The company anticipates releasing the top-line six-week efficacy data—representing the trial’s primary endpoint—by late June 2025. This will be the first pivotal data to emerge from Compass’ phase 3 program.
- 26-week Data Timeline: The full 26-week results from COMP005 are expected after completion of part A in the companion COMP006 trial. Compass projects that the 26-week data from COMP006 will be available in the second half of 2026.
- Long-term Durability Insights: Compass recently published 52-week follow-up data from an observational extension of earlier trials. This data showed a durable treatment response in patients who received a single 25mg dose of COMP360. Among the 252 participants observed, the median time to a new depressive event was 92 days. Notably, in a subgroup of 58 participants who continued into the COMP004 long-term extension, the median time to relapse extended to 189 days. These findings support COMP360’s potential for sustained symptom relief after just one administration.
COMP360 in Post-Traumatic Stress Disorder (PTSD)
Building on its success in TRD, Compass is now advancing COMP360 as a treatment for PTSD, a serious and often debilitating condition with few effective treatment options. The company is currently designing a late-stage clinical development program to evaluate COMP360 in this indication.
In May 2024, Compass reported positive results from a phase 2 open-label study assessing the safety and tolerability of COMP360 in individuals with PTSD. The 12-week study, which enrolled 22 participants, found that COMP360 was well tolerated and led to both rapid and sustained improvements in PTSD symptoms following a single administration. These encouraging results have laid the groundwork for Compass to expand its development pipeline into other trauma-related disorders.
Financial Performance – Q1 2025
Compass Pathways reported a net loss of $17.9 million for the first quarter of 2025, a significant improvement compared to a net loss of $35.2 million in the same quarter of 2024. On a per-share basis, this equated to a loss of $0.20 (basic) and $0.24 (diluted) per share, compared with a loss of $0.55 per share (basic and diluted) a year earlier.
The improved bottom line was largely driven by a non-cash gain of $19.5 million, stemming from a fair value adjustment on the company’s outstanding warrant liabilities. Because the fair value of these warrants is influenced by fluctuations in the company’s stock price and broader market conditions, this line item can introduce volatility into reported earnings.
Research and Development (R&D) Spending
R&D expenses rose to $30.9 million for the quarter, up from $24.9 million in Q1 2024. This increase reflects higher costs associated with advancing the late-stage COMP360 trials. However, these expenses were partially offset by reduced personnel and lower non-cash share-based compensation, following the company’s strategic reorganization in late 2024. This restructuring was aimed at streamlining operations and optimizing resources ahead of critical clinical milestones.
General and Administrative (G&A) Expenses
G&A expenses increased to $18.7 million, up from $13.7 million in the prior-year quarter. The increase was primarily related to costs associated with the company’s 2025 financing activities, along with elevated expenses for consulting, accounting, and legal services.
Share-Based Compensation
Non-cash share-based compensation totaled $3.9 million in Q1 2025, compared to $5.1 million in Q1 2024, reflecting a decline in headcount and stock-based awards post-restructuring.
Capital Position and Fundraising
As of March 31, 2025, Compass reported cash and cash equivalents totaling $260.1 million, representing a substantial increase from $165.1 million at the end of 2024. The company successfully raised $140.4 million in net proceeds during the first quarter of 2025, significantly bolstering its financial flexibility.
This strengthened capital position ensures that Compass has sufficient funding to support its operations through at least the release of the anticipated 26-week data from the COMP006 trial in the second half of 2026.
Looking ahead, Compass anticipates that net cash used in operating activities for the full year 2025 will range between $120 million and $145 million. This guidance reflects the company’s investment in advancing late-stage clinical programs and preparing for potential regulatory submissions.
Importantly, the company expects that its cash reserves as of the end of Q1 2025 will be adequate to fund both operating and capital expenditures through key upcoming data readouts and into the second half of 2026.
Compass Pathways enters the remainder of 2025 with strong clinical momentum and a fortified balance sheet. The upcoming data from the pivotal COMP005 trial in TRD represents a watershed moment for both the company and the broader field of psychedelic medicine. As Compass continues to pursue its vision of transforming mental health care, its work could have a profound impact on how serious psychiatric conditions are treated in the future.
