5Y6 Compass Pathways Plc

Compass Pathways enters into research collaboration agreement with Hackensack Meridian Health to develop optimal clinical model for investigational COMP360 psilocybin treatment, if FDA-approved
Compass Pathways plc (Nasdaq: CMPS) (“Compass”), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, and Hackensack Meridian Health (“HMH”), a leading not-for-profit health care organization and the largest, most comprehensive and truly integrated network in New Jersey, today announced that that they have entered into a research collaboration agreement to inform the delivery model design of investigational COMP360 psilocybin treatment, if FDA-approved. 

The collaboration between Compass and HMH aims to improve health outcomes and improve patient and provider experiences for mental health conditions such as treatment-resistant depression. Together they will work to understand the real-world challenges and opportunities of delivering care to those living with depression, to inform how future clinical trials of COMP360 psilocybin treatment are designed, and to understand how it will be delivered to patients, if approved. COMP360 is Compass’s investigational proprietary formulation of synthetic psilocybin, administered in conjunction with psychological support.

Hackensack Meridian Health offers a complete range of medical services, innovative research and life-enhancing care. The network has 18 hospitals and more than 500 patient care locations. The network’s notable distinctions include having the only #1 ranked adult and children's hospitals in New Jersey, as ranked by U.S. News & World Report, 2023-24. Hackensack University Medical Center is nationally-ranked by U.S. News & World Report in six specialties.

“We’re proud to collaborate with Compass Pathways, a leading biotechnology company aiming to create real change for people suffering with some of the most difficult-to-treat mental health conditions,” said Robert C. Garrett, FACHE, CEO of Hackensack Meridian Health. “Our network’s leadership in mental health and extensive experience in treating depression in clinical practice will inform how new mental health treatments may be accessed by patients in the future.” 

“Our collaboration with Hackensack Meridian Health will help us understand how investigational COMP360 psilocybin treatment, if approved, could be delivered to patients, and represents another important milestone in our mission to provide better treatment options for people who urgently need them,” said Kabir Nath, CEO of Compass Pathways. “As one of the largest, most comprehensive and truly integrated health care networks in the US, with a strong mission to improve clinical outcomes and transform healthcare delivery, HMH is a great collaboration partner for Compass.”

About Compass Pathways

Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by 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).

We have commenced a phase 3 clinical program of COMP360 psilocybin treatment in TRD, the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single 25mg dose of COMP360 psilocybin with psychological support. We are also conducting phase 2 clinical studies of COMP360 psilocybin treatment for post-traumatic stress disorder (PTSD) and anorexia nervosa.

Compass is headquartered in London, UK, with offices in New York and San Francisco in the United States. Our vision is a world of mental wellbeing. www.compasspathways.com.

About Hackensack Meridian Health

Hackensack Meridian Health is a leading not-for-profit health care organization that is the largest, most comprehensive and truly integrated health care network in New Jersey, offering a complete range of medical services, innovative research and life-enhancing care. The network has 18 hospitals and more than 500 patient care locations, which include ambulatory care centers, surgery centers, home health services, long-term care and assisted living communities, ambulance services, lifesaving air medical transportation, rehabilitation centers, urgent care centers, physician practice locations, and a fitness and wellness center. With more than 35,000 team members and 7,000 physicians, Hackensack Meridian Health is a distinguished leader in health care philanthropy and committed to the health and well-being of communities throughout New Jersey.

The network’s notable distinctions include having the only #1 ranked adult and children's hospitals in New Jersey, as ranked by U.S. News & World Report, 2023-24. Hackensack University Medical Center is nationally-ranked by U.S. News & World Report in six specialties. To learn more, visit www.hackensackmeridianhealth.org.

Availability of other information about Compass Pathways

Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward-looking statements

Compass Pathways:

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”, “will”, “could”, “would”, “expect”, “intend”, “plan”, “anticipate”, “believe”, “potential” and “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, the safety or efficacy of investigational COMP360 psilocybin treatment as a treatment for depression, post-traumatic stress disorder or anorexia nervosa, the potential for the pivotal phase 3 program or other trials to support regulatory filings and approvals, Compass’s business strategy and goals, Compass’s plans, expectations and ability to achieve its goals related to this research collaboration agreement; Compass’s ability to continue to advance its research, obtain regulatory approval or develop plans to bring COMP360 psilocybin treatment to patients, and Compass’s expectations regarding the benefits of its 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: clinical development is lengthy and outcomes are uncertain, and therefore Compass’s clinical trials may be delayed or terminated; the results early-stage clinical trials of investigational COMP360 psilocybin treatment may not be predictive of the results of later stage clinical trials; Compass’s efforts to obtain marketing approval from the applicable regulatory authorities in any jurisdiction for COMP360 or any of future product candidates may be unsuccessful, and Compass’s efforts to obtain coverage and reimbursement for its investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; the risk that this research collaboration with Hackensack Meridian Health will not continue or will not be successful; and those risks and uncertainties described under the heading “Risk Factors” in Compass’s 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 www.sec.gov. 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’s current expectations and speak only as of the date hereof.

Enquiries

Compass Pathways:

Media: Amy Lawrence, media@compasspathways.com, +44 7813 777 919Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324

Hackensack Meridian Health:

Media: Jessica Nussman, jessica.nussman@hmhn.org, 551-237-0984; Elizabeth Llorente, Elizabeth.Llorente@hmhn.org, 646-573-8487