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COMPASS Pathways(CMPS) - 2025 Q3 - Quarterly Report

Financial Performance - The company has not generated any revenue to date and does not expect to do so in the near future from therapeutic candidates[94] - As of September 30, 2025, the company reported net losses of $194.0 million and $111.8 million for the nine months ended September 30, 2025 and 2024, respectively[88] - The company has an accumulated deficit of $728.7 million as of September 30, 2025[88] - The net loss for Q3 2025 was $137.7 million, compared to a net loss of $38.5 million in Q3 2024, reflecting an increase of 357%[108] - For the nine months ended September 30, 2025, total operating expenses were $133.1 million, an increase of 3% from $129.8 million in the same period of 2024[108] - For the nine months ended September 30, 2025, net cash used in operating activities was $119.5 million, an increase of $42.0 million compared to the same period in 2024[119] Cash and Funding - The company had cash and cash equivalents of $185.9 million as of September 30, 2025, which is expected to fund operations into 2027[89] - The company reported a net cash provided by financing activities of $140.5 million for the nine months ended September 30, 2025, an increase of $76.9 million compared to the same period in 2024[121] - The company has funded $30.0 million of the $50.0 million available under the Hercules Loan Agreement[115] - The company has sold 5,491,836 ADSs under its ATM offering program, resulting in $54.8 million in net proceeds[115] Research and Development - The company received Breakthrough Therapy designation from the FDA for its COMP360 psilocybin treatment for treatment-resistant depression (TRD) in 2018[76] - The Phase 2b clinical trial for COMP360 demonstrated a statistically significant reduction in depressive symptom severity with a 25mg dose compared to a 1mg dose, achieving a p-value of p<0.001[79] - The company commenced its Phase 3 program for COMP360 in TRD at the beginning of 2023, consisting of two pivotal trials[77] - The first pivotal trial (COMP005) has enrolled 258 participants and achieved its primary endpoint[79] - The second pivotal trial (COMP006) has completed enrollment with 585 participants and is designed to investigate the effects of a second dose on therapeutic response[81] - The company expects to continue incurring significant R&D costs through the completion of its Phase 3 program for COMP360 psilocybin therapy[110] - The benefit from R&D tax credit increased to $16.7 million for the nine months ended September 30, 2025, compared to $10.9 million in the same period of 2024, reflecting higher R&D expenditures[114] - Research and development expenses for Q3 2025 were $27.3 million, a decrease of 17% from $32.9 million in Q3 2024[109] Operating Expenses - Total operating expenses for Q3 2025 were $40.5 million, down 15% from $47.9 million in Q3 2024[108] - General and administrative expenses for Q3 2025 were $13.2 million, a decrease of 12% from $15.0 million in Q3 2024[111] - The company anticipates ongoing increases in expenses associated with operating as a public company, including legal and accounting costs[122] - The company expects to incur significant commercialization expenses related to product manufacturing and pre-commercial activities as it advances its Phase 3 program for COMP360 in TRD[122] Market and Regulatory Status - The company qualifies as a "smaller reporting company" under the Securities Exchange Act of 1934, allowing it to utilize scaled disclosures[132] - Annual revenues are reported to be less than $100.0 million, which exempts the company from certain reporting requirements[132] - The company is not required to provide an attestation report on internal control over financial reporting due to its status as a smaller reporting company[132] - The threshold for non-affiliate voting and non-voting shares is set at less than $250.0 million for continued scaled disclosures[132] - There have been no material changes in market risk exposures affecting disclosures since the last Annual Report[133] Other Financial Metrics - The company recorded a fair value change of warrant liabilities amounting to $(101.3) million in Q3 2025, compared to no such expense in Q3 2024[108] - The benefit from R&D tax credit for Q3 2025 was $3.9 million, slightly down from $4.1 million in Q3 2024[108] - Accumulated trading losses for carry forward in the UK were $339.7 million as of December 31, 2024[106] - The company anticipates reduced personnel expenses in 2025 compared to 2024 due to a reorganization undertaken in Q4 2024[98]