5Y6 Compass Pathways Plc

Compass Pathways and Journey Clinical establish research collaboration agreement to inform the training of healthcare providers and delivery model for COMP360 psilocybin treatment, if approved for treatment-resistant depression
Compass Pathways plc (Nasdaq: CMPS) (“Compass”), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, and Journey Clinical, a leading psychedelic-assisted psychotherapy platform with the largest network of licensed therapists focused on psychedelics in the US, today announced they have entered into a research collaboration agreement to inform the development of a scalable and practical delivery and healthcare provider training model for COMP360 psilocybin treatment, if approved for treatment-resistant depression (TRD).

The first phase of the collaboration comprises an in-depth information exchange on the COMP360 psilocybin treatment delivery model. Together, Compass and Journey Clinical will work to better understand the patient care experience, depression patient pathways and care reimbursement processes, and explore innovative care pathways for TRD patients, should COMP360 psilocybin treatment be approved. They will conduct research into therapist training, support, and education, and exchange information on treatment settings for psychedelic therapies.

Journey Clinical has built the necessary infrastructure to support broad access to new psychedelic treatments for mental health conditions, if and when approved. Their collaborative care model connects a dedicated medical team, licensed psychotherapists, and patients, supporting the delivery of psychedelic treatments responsibly and at scale, starting with ketamine-assisted psychotherapy. They have a network of over 2,000 therapists, an in-house model of therapist peer support and mentorship, and are partnered with leading therapist training providers.

“We are thrilled to be a research collaboration partner for Compass and to contribute towards how COMP360 psilocybin treatment may be delivered to patients across the US, if it receives regulatory approval,” said Jonathan Sabbagh, co-founder and CEO of Journey Clinical. “This collaboration with Compass is closely aligned with Journey Clinical’s aim to support the millions of people in the US living with mental illness to access psychedelic treatments safely and effectively.”

Compass has previously announced research collaboration agreements with Greenbrook TMS, a leading provider of interventional psychiatric treatments such as transcranial magnetic stimulation, and Hackensack Meridian Health, a leading not-for-profit health care organization and the largest, most comprehensive and truly integrated network in New Jersey, addressing the full continuum of care for people living with TRD.

“Compass is forming a comprehensive and diverse network of research collaborations to inform how COMP360 psilocybin treatment can be best integrated into the US health system,” said Kabir Nath, CEO of Compass Pathways. “As a leader in bringing psychedelic treatments to patients in the US safely, responsibly, and at scale, Journey Clinical will be a valuable collaboration partner for Compass. Together, we will further refine our understanding of how COMP360 psilocybin treatment could be delivered to patients in the future.”

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 Journey Clinical

Journey Clinical is on a mission to transform the growing mental health crisis by accelerating the mainstream adoption of legal, evidence-based Psychedelic-Assisted Psychotherapy as the standard of care for mental health, starting with Ketamine-Assisted Psychotherapy. They have built a leading platform for Psychedelic-Assisted Psychotherapy in the US. Therapists partner with Journey Clinical’s medical team, which acts as their in-house doctor, giving them access to a hospital system that supports their practice. Therapists also receive access to training, mentorship, community, and patient referrals, enabling them to grow their practice and to deliver the highest standard of care to their clients. Patients seeking these treatments are supported by a dedicated care team, composed of a licensed therapist of their choice and Journey Clinical medical providers collaborating to build a treatment plan that meets their needs and supports their recovery.

For more information, visit www.JourneyClinical.com. 

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 treatment-resistant 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 Journey Clinical will not continue or will not achieve the expected benefits; uncertainties regarding the ability to develop a scalable and practical delivery and healthcare provider training model for COMP360 psilocybin treatment; market adoption and access to COMP360 psilocybin treatment, if approved, may be limited 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

Journey Clinical:

Media: Alina Zolotareva, press@journey.clinicInvestors: Jonathan Sabbagh, investors@journey.clinic