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Compass Pathways Establishes Strategic Collaboration with HealthPort to Inform the Potential Delivery of COMP360 Synthesized Psilocybin Treatment in Underserved Communities

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Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation announced today it is entering into a strategic collaboration with HealthPort, a multi-site comprehensive community health organization. HealthPort employs an integrated model centered around social determinants of health and this collaboration will help inform the potential delivery of COMP360 synthesized psilocybin treatment in underserved communities, if FDA approved. This agreement with HealthPort expands the set of collaborations that Compass has established representing a broad spectrum of settings where people living with treatment resistant depression (TRD) receive their care in the United States.

HealthPort offers an integrated model of care aimed at helping those with behavioral health conditions and people impacted by poverty, disability and trauma. HealthPort is an evidence-based practice supporting thirteen dimensions of social determinants of health, including the coordination of an integrated outpatient mental health and addictions health clinic. HealthPort has been operating facility, residential, and mobile based interventions of care in the lower Eastern Shore of Maryland for the past 45 years.

Together, Compass and HealthPort will learn about the challenges and barriers to equitable access to new mental health treatments and they will conduct research into training and care reimbursement processes for COMP360, if approved. The companies will explore how investigational COMP360 synthesized psilocybin treatment might fit into an integrated health delivery practice similar to HealthPort. This exploration is designed to provide a template for potential future implementation and delivery of COMP360 within community care settings across the US. COMP360 is a synthesized, proprietary formulation of psilocybin under investigation as a treatment for certain difficult-to-treat mental health conditions, including treatment resistant depression (TRD).

“We are proud to collaborate with Compass Pathways and to contribute to learning how COMP360 psilocybin treatment may be most effectively delivered to patients in underserved communities, if that treatment receives all necessary approvals for TRD,” said Dimitrios Cavathas, CEO of HealthPort. “We are committed to addressing the social determinants of health that impact our community members and collaborating with Compass will help further our mission to serving the unique needs of our people.”

“We strive to improve mental healthcare for every person who needs help, and we recognize the challenges to access for underserved populations and the potential for innovative treatments, such as COMP360, to lessen existing disparities, if approved,” said Steve Levine, Chief Patient Officer of Compass Pathways. “We are thrilled to join forces with a leading integrated community health center, such as HealthPort, to further refine our understanding of how COMP360 psilocybin treatment could be delivered to patients in the future and, together, advance equitable access to mental healthcare.”

About Compass Pathways’ strategic collaborations

Compass is forming a comprehensive and diverse set of collaborations to inform how investigative COMP360 synthesized psilocybin treatment can be integrated into different types of healthcare delivery systems in the US.

Compass also has previously announced collaboration agreements with Greenbrook TMS, a leading provider of interventional psychiatric treatments such as Spravato and transcranial magnetic stimulation; 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; Reliant Medical Group, an Optum company and integrated primary and specialty care organization; Journey Clinical, a leading psychedelic-assisted psychotherapy platform in the US; and Mindful Health Solutions, one of the US’s leading providers of innovative behavioral health care.

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 synthesized psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US 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 and San Francisco in the US. 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”, “should”, “expect”, “intend”, “plan”, “believe”, “estimate”, “predict”, “possible”, “potential” 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 strategic collaboration agreement and its other collaborations; Compass’s ability to continue to advance its research, obtain regulatory approval or develop plans to bring investigational 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; the possibility of unfavorable results from additional clinical trials of investigational COMP360 psilocybin treatment or from subsequent analysis of existing data or new data received from additional ongoing and future studies of investigational COMP360 psilocybin treatment; Compass’s efforts to obtain marketing approval from the applicable regulatory authorities in any jurisdiction for investigational COMP360 or any of future product candidates may be unsuccessful; Compass’s efforts to obtain coverage and reimbursement for its investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; the risk that this collaboration with HealthPort or one or more of our previously announced collaborations will not continue or will not achieve the expected benefits; uncertainties regarding the ability to develop a scalable and cost-effective delivery model for investigational COMP360 psilocybin treatment, if approved; the risk that market adoption and access to investigational 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250429198140/en/

Contacts

Enquiries
Media: Dana Sultan-Rothman, media@compasspathways.com, +1 484 432 0041
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324

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