Compass Pathways Announces U.S. Grant Program Recipients for the Development of Post-Approval COMP360 Provider Training

Five organizations awarded grants, above the planned three, as a result of a competitive selection process with highly qualified applicants Training guidance is designed to prepare healthcare providers to deliver high-quality treatment experiences to patients receiving COMP360, if approved

Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care, announced today the U.S. grant program recipients to create training programs for healthcare providers (HCPs) that will be involved in the delivery of psychedelic treatments, such as COMP360 psilocybin. These programs are intended to address both the need for foundational training in psychedelics, as well as ensuring HCPs are well-prepared to care for patients receiving treatment with COMP360 following its expected commercial launch, if approved.

The recipients were selected through a competitive application process based on their expertise and proven ability to develop and deliver high-quality training at scale. They will remain independent training and education providers, retaining ownership and control of their training programs, content, faculty selection, and educational design, consistent with ACCME Standards for Integrity and Independence in Accredited Continuing planned Education, with Compass providing the grant program funding and recognizing them as grant awardees. In all, five organizations were awarded the grant, expanded from the originally three recipients due to the overall quality of applicants:

• CME Outfitters, LLC (Radnor, PA)
• Emory University (Atlanta, GA)
• Fluence International, Inc. (Bronx, NY)
• Integrative Psychiatry Institute, LLC (Longmont, CO)
• Strata Mental Health Solutions, LLC (Atlanta, GA)

“As the leader in psychedelic treatment, we believe advancing COMP360 to reach patients requires doing it the right way – with scientific rigor, detailed intention and an unwavering focus on patient safety, access and experience,” said Dr. Steve Levine, Chief Patient Officer at Compass Pathways. “COMP360 represents a distinctly new approach to treatment-resistant depression management, and we recognize that delivering this model of care requires a care workforce with the right skills and capabilities to offer a high-quality experience from preparation, treatment administration, and through follow-up. We are thrilled to work with the organizations selected through a competitive review process, and confident in their ability to help drive system readiness for what we believe to be the future of mental health care.”

Compass has also created guidance documents for real-world delivery and consistent training guidance available upon request. These documents, developed independently by Compass, are separate from the training programs developed by grant awardees, and may serve as resources for others to develop trainings. Interested HCPs may submit requests to: USMedInfo@compasspathways.com.

About Compass’ U.S. healthcare provider training grant program

The Compass U.S. HCP training grant program is designed to support foundational training in psychedelics, as well as the additional development of structured, high-quality training to accompany the expected U.S. commercial launch of COMP360 for TRD. Compass provides grant funding to support awardees in independently developing training content, delivery platforms, and materials as part of operational readiness across sites of care post approval. Applicants were asked to demonstrate experience and capabilities in psychedelics training design, delivery, and governance; ability to scale; focus on access and inclusion; and regulatory alignment, among other aspects.

About treatment resistant depression (TRD)

Depression, one of the most common mental health disorders, significantly impacts relationships, work performance, overall quality of life, and is associated with an increased risk of suicide. Major depressive disorder (MDD) has been ranked as the third cause of the burden of disease worldwide in 2008 by the World Health Organization (WHO), which has projected that this disease will rank first by 2030.

It is estimated that approximately 4 million patients in the U.S. with MDD live with TRD¹. TRD is broadly defined as an inadequate response to two or more appropriate courses of approved medications. TRD has a significantly greater impact on individuals compared to MDD, leading to residual symptoms, poorer quality of life, increased comorbidities, higher mortality, and an increased risk of suicide compared to non-treatment resistant MDD.

About Compass Pathways

We believe mental health patients deserve the possibility of a better future. Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care. Our initial focus is developing COMP360 psilocybin, a proprietary, investigational, synthetic psilocybin treatment under evaluation for treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD). COMP360 is a potentially first-in-class treatment and has Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA), as well as Innovative Licensing and Access Pathway (ILAP) designation in the UK for TRD. We are leading the world’s largest classic psychedelic clinical program in TRD, and building upon that robust foundation, we are executing a late-stage trial evaluating COMP360 for PTSD, another condition with high unmet need. Our goal is to advance treatments that move the field of psychiatry towards treatment options that offer rapid onset and sustained durability with infrequent dosing.

Compass is headquartered in London, UK, with a U.S. office in New York.

We are driven by our purpose of unlocking pathways to be – opening futures filled with possibility. Together, we are on an ambitious journey toward enabling people living with mental health conditions to find clarity through self-discovery, because every journey needs a Compass.

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 business strategy and goals; our plans and expectations regarding this U.S. healthcare provider training grant program and the availability of training programs for U.S. healthcare providers; the potential for our current or any future clinical trials to support regulatory filings and approvals for COMP360 psilocybin treatment; our expectations regarding the safety or efficacy of our investigational COMP360 psilocybin treatment, including as a treatment for treatment of TRD and PTSD; 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; our expectations regarding our commercial readiness and scalability of infrastructure and training programs to deliver treatment at scale, if regulatory approval is obtained; 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; our need for substantial additional funding to achieve our business goals and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our clinical trials; our efforts to obtain marketing approval from the applicable regulatory authorities in any jurisdiction for our investigational COMP360 psilocybin treatment may be unsuccessful; our efforts to commercialize and obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; the risk that this U.S. healthcare provider training grant program will not continue or will not achieve its goals or that the training programs for U.S. healthcare providers will not be available or achieve the anticipated benefits 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.

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