Highlights: 6-week top-line data from Part A of COMP005 phase 3 trial in treatment resistant depression on track for late June Phase 3 COMP006 in TRD on track for 26-week data second half of 2026 Cash position of $260.1 million at March 31, 2025 Conference call on May 8 at 8:00 am ET (1:00 pm UK)
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported its financial results for the first quarter 2025 and provided an update on recent progress across its business.
“We eagerly await the upcoming topline 6-week data readout, on track for late June, the first data from our pivotal phase 3 COMP360 program in treatment resistant depression.” said Kabir Nath, Chief Executive Officer. “Our continued progress reinforces Compass’ leadership in psychedelic therapy development, which we believe represents the next generation of mental health therapeutic options and can lead to significant value creation.”
COMP360 psilocybin treatment in TRD (Treatment Resistant Depression)
- The pivotal phase 3 clinical program of COMP360 psilocybin treatment in TRD is the largest-to-date randomized, controlled, double-blind psilocybin treatment clinical program.
- All participants have completed dosing in part A of the COMP005 phase 3 trial for TRD and top-line 6-week (primary endpoint) data are expected in late June.
- 26-week COMP005 data is expected once all participants in the COMP006 trial have completed part A of the COMP006 trial.
- COMP006 26-week data is expected in the second half of 2026.
- Recent 52-week data from an observational follow-up study published on COMP360 demonstrated a durable treatment response and a median time to depressive event of 92 days (n=252) on a single 25mg administration and 189 days (n=58) for the 25mg subgroup that continued into the COMP004 long-term extension
COMP360 psilocybin treatment in PTSD (Post Traumatic Stress Disorder)
- Company designing late-stage clinical trial program
- Phase 2 open label 12-week safety and tolerability study (n=22) announced in May 2024, showed COMP360 was well tolerated and demonstrated both rapid and durable improvement in symptoms from baseline observed following a single administration.
- Net loss for the three months ended March 31, 2025, was $17.9 million, or $0.20 net loss per share: basic, $0.24 net loss per share: diluted, compared with $35.2 million, or $0.55 loss per share basic and diluted, during the same period in 2024. The decrease in net loss for the quarter was primarily driven by a $19.5 million non-cash gain on fair value adjustment related to our warrant liabilities. As the fair value of the warrants fluctuates with our share price and other market inputs, this adjustment can result in significant variability in our reported net loss.
- Non-cash share-based compensation for the three months ended March 31, 2025 was $3.9 million compared with $5.1 million for the same period in 2024.
- Research and development expenses were $30.9 million for the three months ended March 31, 2025, compared with $24.9 million during the same period in 2024. The increase was primarily attributable to development expenses associated with advancing our late-stage COMP360 phase 3 clinical trials partially offset by decreased personnel and non-cash share-based compensation expenses due to decreased staffing levels associated with the strategic reorganization that took place in the fourth quarter of 2024.
- General and administrative expenses were $18.7 million for the three months ended March 31, 2025, compared with $13.7 million during the same period in 2024. The increase was primarily attributable to issuance costs related to the 2025 Financing as well as expenses associated with consulting, accounting and legal advice.
- Gain on change in fair value of warrants for the three months ended March 31, 2025, was $19.5 million compared with $0.0 million during the same period in 2024.
- Cash and cash equivalents were $260.1 million as of March 31, 2025, compared with $165.1 million as of December 31, 2024.
- An additional $140.4 million net cash raised in the first quarter of 2025.
Full year 2025 net cash used in operating activities is expected to be in the range of $120 million to $145 million. The cash position at March 31, 2025 is expected to be sufficient to fund operating expenses and capital expenditure requirements at least through the planned 26-week data read-out from the COMP006 study, which is expected in the second half of 2026.
The management team will host a conference call at 8:00 am ET (1:00 pm UK) on May 8, 2025. A live webcast of the call will be available on the Compass Pathways website at First Quarter 2025 Financial Results.
Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthesized psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).
Compass is headquartered in London, UK, with offices in New York and San Francisco in the US. We envision a world where mental health means not just the absence of illness but the ability to thrive.