ADDED
Dollar), the risk of an economic slowdown or recession in the U.S., instability in the banking system, overall market volatility in the U.S.
or the UK, including as a result of, among other factors, geopolitical conflict (such as, the war between Russia and Ukraine and conflict in the Middle East), international tensions or instability (including from the effects of announced or future tariff increases), significant changes in U.S.
References to we, our, us and the Company refer to Compass Pathways plc.
We expect to incur losses for the foreseeable future and may never achieve or maintain profitability; Unless and until we generate product revenue and achieve and sustain profitability, we will continue to need additional financing to fund our operations and capital expenditures.
If we are unable to do so, our commercialization prospects would be limited and our business would be harmed; In our clinical trials, we currently rely on specially trained, licensed healthcare professionals working at third-party clinical trial sites and upon regulatory approval we expect to continue to rely on healthcare professionals working at third-party sites, to monitor and safeguard participants during administration of our COMP360 psilocybin treatment.
In 2018, we received Breakthrough Therapy designation from the U.S.
Food and Drug Administration, or the FDA, for COMP360 for the treatment of TRD.
In 2025, we completed enrollment for each of the two pivotal trials in our Phase 3 program evaluating our COMP360 psilocybin treatment in TRD.
Each of the two pivotal trials has a long-term follow-up component.
Pivotal trial 2 (COMP006) (n=581): a fixed repeat dose monotherapy using three dose arms: 25mg, 10mg and 1mg.
REMOVED
Dollar, the risk of economic slowdown or recession in the U.S., instability in the banking system, overall market volatility in the U.S.
or the UK, including as a result of, among other factors, the ongoing war between Russia and Ukraine, conflict in the Middle East, the potential for significant changes in U.S.
We expect to incur losses for the foreseeable future and may never achieve or maintain profitability; We will need substantial additional funding to complete the development and commercialization of our investigational COMP360 psilocybin treatment.
Our outstanding warrants may not be exercised for cash before such warrants expire and we may not receive any additional proceeds from such warrants.
Our ability to raise additional funds may be adversely impacted by macroeconomic conditions, changing regulatory conditions, and disruptions to and volatility in the credit and financial markets in the U.S.
In addition, during the review process of COMP360, and prior to any potential approval, the FDA and/or other regulatory bodies may require additional data, including with respect to whether COMP360 has abuse or misuse potential, which may delay approval and any potential rescheduling process; COMP360 contains controlled substances, the use of which may generate public controversy.
Adverse publicity or public perception regarding COMP360, in particular, and psilocybin-based treatments, in general, or our future investigational treatments using psilocybin may negatively influence the success of these treatments; Clinical drug development is a lengthy and expensive process with uncertain timelines and uncertain outcomes.
We have experienced delays in recruitment for our clinical trials of COMP360 psilocybin treatment, which has increased the costs of our Phase 3 clinical trials and caused delays in expected timing to complete such clinical trials.
If we experience additional delays in the future for our clinical trials of COMP360 psilocybin treatment, we or our future collaborators may be unable to obtain required regulatory approvals, and therefore we will be unable to commercialize our investigational COMP360 psilocybin treatment on a timely basis or at all, which will adversely affect our business; COMP360 psilocybin treatment may have serious adverse, undesirable or unacceptable side effects which may delay or prevent marketing approval.
If third-party sites fail to recruit and retain a sufficient number of qualified healthcare professionals or effectively manage such professionals, as applicable, our clinical trials may be delayed and our business, financial condition and results of operations would be materially harmed; Intellectual property rights of third parties could adversely affect our ability to develop or commercialize our investigational treatments, such that we could be required to litigate or obtain licenses from third parties in order to develop or market our investigational treatments.