Psilocybin

LONDON & NEW YORK--(BUSINESS WIRE)-- $CMPS #Biotech --Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced the election of Kathleen Tregoning to its Board of Directors at the annual general meeting of shareholders. Ms. Tregoning is expected to serve on the Compensation and Leadership Development Committee and the Nominating and Corporate Governance Committee. She brings extensive experience guiding biopharmaceutical companies through periods of growth and transformation, with expertise spanning corporate strategy, external affairs, public policy and patient access. “With two successful Phase 3 trials meeting the primary endpoint, a transformative clinical pro COMP360, and a rolling NDA submission and review now underway, Compass is strongly positioned to make our goal of securing an FDA approval a reality. Compass is entering a stage where experience in external engagement, public policy, and patient access matters more than ever,” said Kabir Nath, Chief Executive Officer of Compass Pathways. “Kathleen has built and led these functions at scale across multiple biopharma organizations, and she brings the perspective we need as we work to potentially deliver a new treatment option to people living with treatment-resistant depression. We are delighted to welcome her to the Board.” Ms. Tregoning most recently served as Chief Corporate Affairs Officer and Head of Commercial Strategy at Cerevel Therapeutics, where she guided the company through a period of significant growth, culminating in its acquisition by AbbVie in 2024. Previously, she served as Executive Vice President, External Affairs at Sanofi, where she led an integrated organization overseeing global market access, public policy, government affairs, communications, patient advocacy and corporate social responsibility. Prior to Sanofi, Ms. Tregoning spent more than a decade at Biogen in corporate affairs. Earlier in her career, Ms. Tregoning served as a professional staff member in the United States Congress, holding health policy roles across various committees. She currently serves on the Board of Directors of Spero Therapeutics, Inc. (Nasdaq: SPRO). Ms. Tregoning earned a B.A. in International Relations from Stanford University and an M.A. in Public Policy from the Harvard Kennedy School. “COMP360 has the potential to offer a groundbreaking option and renewed hope for people living with treatment-resistant depression, a population that has waited far too long for innovation,” said Kathleen Tregoning. “Compass is laying the groundwork to engage patients, providers, policymakers, and payers. As the company progresses toward regulatory review and potential commercialization, expanding education and access will be as critical as the science itself. At a time when the need for new mental health treatment options is more urgent than ever, I am honored to join the Board and look forward to supporting the team as they work to bring COMP360 to the patients who need it the most.” About Compass Pathways 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 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the U.S. 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 in the U.S. We envision a world where mental health means not just the absence of illness but the ability to thrive. Forward-looking statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “anticipate”, “believe”, “contemplate”, “estimate”, “predict”, “potential”, “continue” and “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, statements regarding our expectations regarding our business strategy and goals; our expectations regarding the safety or efficacy of our investigational COMP360 psilocybin treatment, including as a treatment for TRD or PTSD; any implication that past results will be predictive of future results; our plans and expectations regarding our clinical trials, including our ongoing phase 3 trials in TRD and our phase 2b/3 trial in PTSD; our expectations regarding the timing of our rolling submission of a new drug application, or NDA, for COMP360 psilocybin treatment in TRD and the timing of the review by the Food and Drug Administration, or FDA, of such NDA, including potential acceleration due to the grant of rolling review and award of a Commissioner’s National Priority Voucher, or CNPV, for COMP360 psilocybin treatment in TRD; our expectations regarding the potential benefits of being selected for Commissioner's National Priority Voucher pilot program, including without limitation, reduced review timelines following submission of a new drug application; our expectations regarding potential commercial launch timelines and our commercial readiness; the potential for the pivotal phase 3 program in TRD to support regulatory filings and approvals on an accelerated basis or at all; our efforts and our ability to obtain regulatory approval and adequate coverage and reimbursement; our ability to transition from a clinical-stage to a commercial-stage organization and effectively launch a commercial product, if regulatory approval is obtained, on an accelerated timeline or at all; and our expectations regarding the benefits of our investigational COMP360 psilocybin treatment. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Compass’s control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: uncertainties associated with risks related to clinical development which is a lengthy and expensive process with uncertain outcomes, and therefore our clinical trials may be delayed or terminated and may be more costly than expected; that the full results and safety data from our Phase 3 clinical trials in TRD may not be consistent with the preliminary results to date; that the rolling review process and/or the Commissioner's National Priority Voucher pilot program may not actually lead to a faster FDA review or approval process; that the Commissioner’s National Priority Voucher pilot program does not change the safety and efficacy standards for approval or the quality of evidence necessary to support approval of COMP360 and our efforts to obtain FDA approval, or approval from regulatory authorities in other jurisdictions, for our investigational COMP360 psilocybin treatment may be unsuccessful; that our efforts to commercialize and obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; that we may not be able to retain key personnel; and those risks and uncertainties described under the heading “Risk Factors” in Compass’ most recent annual report on Form 10-K or quarterly report on Form 10-Q and in other reports we have filed with the U.S. Securities and Exchange Commission (“SEC”), which are available on the SEC’s website at . Except as required by law, Compass disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Compass’ current expectations and speak only as of the date hereof. Contacts Enquiries Media: Dana Sultan-Rothman, media@compasspathways.com Investors: Stephen Schultz, stephen.schultz@compasspathways.com , +1 401 290 7324