COMPASS Pathways(CMPS) - 2025 Q2 - Quarterly Results

Second Quarter 2025 Business Highlights The company announced positive Phase 3 results for COMP360 in TRD and is advancing its PTSD clinical program COMP360 Psilocybin Treatment in TRD (Treatment Resistant Depression) The company announced positive primary endpoint results from its first Phase 3 trial (COMP005) for COMP360 in treatment-resistant depression, demonstrating a statistically significant and clinically meaningful reduction in symptoms at 6 weeks with no unexpected safety findings. The second Phase 3 trial (COMP006) is enrolling well, with 26-week data anticipated in the second half of 2026, and the company is exploring pathways for an accelerated regulatory filing - Achieved a positive primary endpoint in the first COMP360 Phase 3 trial (COMP005), showing a highly statistically significant and clinically meaningful reduction in depression symptoms at 6 weeks after a single administration[3][5][6] - The second pivotal Phase 3 trial (COMP006) is continuing to enroll, with 26-week data expected in the second half of 2026[5][6] - A Data Safety Monitoring Board (DSMB) review found no unexpected safety findings and no clinically meaningful imbalance in suicidal ideation in either Phase 3 study[6] - The company is exploring options for a potential accelerated filing of COMP360 for TRD based on the positive Phase 3 data[5] COMP360 Psilocybin Treatment in PTSD (Post Traumatic Stress Disorder) Following a positive Phase 2 open-label study announced in May 2024, which showed COMP360 was well-tolerated and demonstrated rapid, durable symptom improvement, the company is now finalizing the design for a late-stage clinical trial for PTSD - The company is finalizing the design for a late-stage clinical trial for COMP360 in PTSD[7] - The trial design is informed by a Phase 2 study where a single administration of COMP360 was well-tolerated and showed rapid and durable symptom improvement from baseline[7] Corporate and Financial Highlights Key corporate developments include board changes, a review of financial performance, and updated financial guidance Board of Directors Update Justin Gover, the former CEO of GW Pharmaceuticals, has been appointed to the Compass Pathways Board of Directors. Concurrently, Dr. Linda McGoldrick will retire from her board position at the end of October after more than five years of service - Justin Gover, former CEO of GW Pharmaceuticals, was appointed to the Board of Directors[9] - Dr. Linda McGoldrick is set to retire from the Board at the end of October after over 5 years of service[9] Financial Highlights For Q2 2025, Compass reported a net loss of $38.4 million, slightly up from $38.1 million in Q2 2024, influenced by a non-cash loss on warrant liabilities. For the first six months of 2025, the net loss decreased to $56.3 million from $73.3 million year-over-year, primarily due to a significant non-cash gain on warrant liabilities. R&D expenses rose due to advancing Phase 3 trials, while G&A expenses declined. The company ended the quarter with a strong cash position of $221.9 million | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Net Loss | $38.4M | $38.1M | $56.3M | $73.3M | | Net Loss Per Share | $0.41 | $0.56 | $0.62 | $1.11 | | R&D Expenses | $30.3M | $29.1M | $61.2M | $54.0M | | G&A Expenses | $12.6M | $14.3M | $31.3M | $27.9M | - The significant variability in reported net loss was primarily driven by non-cash fair value adjustments related to warrant liabilities, which resulted in a $2.5 million loss in Q2 2025 and a $16.9 million gain in H1 2025[9][14] - Cash and cash equivalents were $221.9 million as of June 30, 2025, compared to $165.1 million as of December 31, 2024[14] Financial Guidance The company projects its full-year 2025 net cash used in operating activities to be in the range of $120 million to $145 million. Its cash position of $221.9 million as of June 30, 2025, is expected to be sufficient to fund operations and capital expenditures into 2027 - Full year 2025 net cash used in operating activities is expected to be between $120 million and $145 million[11] - The cash position as of June 30, 2025, is expected to provide a cash runway into 2027[5][11] Financial Statements Detailed financial statements provide an overview of the company's balance sheet and operational performance Condensed Consolidated Balance Sheets As of June 30, 2025, total assets grew to $293.5 million from $213.7 million at year-end 2024, driven by an increase in cash to $221.9 million. Total liabilities rose substantially to $131.0 million from $59.0 million, primarily due to the recognition of $74.4 million in warrant liabilities. Consequently, total shareholders' equity increased modestly to $162.6 million | Balance Sheet Item (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $221,881 | $165,081 | | Total assets | $293,536 | $213,666 | | Warrant liabilities | $74,398 | $0 | | Total liabilities | $130,981 | $58,971 | | Total shareholders' equity | $162,555 | $154,695 | Condensed Consolidated Statements of Operations and Comprehensive Loss For the second quarter of 2025, the company reported a net loss of $38.4 million, nearly flat compared to a $38.1 million loss in Q2 2024. For the six months ended June 30, 2025, the net loss improved to $56.3 million from $73.3 million in the prior-year period. This improvement was largely due to a $16.9 million non-cash gain from the change in fair value of warrant liabilities. Operating expenses for the six-month period increased to $92.5 million from $81.9 million, driven by higher research and development costs | Statement of Operations (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Research and development | $30,325 | $29,069 | | General and administrative | $12,608 | $14,253 | | Loss from operations | $(42,933) | $(43,322) | | Fair value change of warrant liabilities | $(2,540) | $0 | | Net loss | $(38,403) | $(38,101) | | Statement of Operations (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Research and development | $61,205 | $53,970 | | General and administrative | $31,344 | $27,925 | | Loss from operations | $(92,549) | $(81,895) | | Fair value change of warrant liabilities | $16,920 | $0 | | Net loss | $(56,267) | $(73,288) | Company Information and Disclosures This section provides an overview of Compass Pathways and standard forward-looking statement disclosures About Compass Pathways Compass Pathways is a biotechnology company dedicated to advancing mental health treatments. Its primary focus is the development of COMP360, an investigational synthetic psilocybin therapy. This therapy has received Breakthrough Therapy designation from the U.S. FDA and an Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) - The company is a biotechnology firm focused on accelerating patient access to evidence-based innovation in mental health[12] - Its lead program is the development of investigational COMP360 synthetic psilocybin treatment, which has received FDA Breakthrough Therapy and UK ILAP designations for treatment-resistant depression (TRD)[12] Forward-looking Statements This section provides a standard safe harbor statement, cautioning that the press release includes forward-looking statements concerning financial guidance, clinical trial timelines, regulatory approval prospects, and commercialization plans. These statements are subject to significant risks and uncertainties, such as clinical development outcomes, funding availability, and regulatory challenges, which could cause actual results to differ materially from expectations - The press release contains forward-looking statements regarding financial guidance, clinical trial timelines (including Phase 3 TRD data), potential for regulatory filings, and commercialization plans[15] - These statements are not guarantees and involve known and unknown risks, including uncertainties in clinical development, the need for additional funding, and potential for unsuccessful marketing approval efforts[16]