Compass Pathways Joins Forces with Leading Mental Health Organizations to Mark First-Ever U.S. Treatment-Resistant Depression (TRD) Awareness Day

Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care, today announced the first-ever TRD Awareness Day in the U.S., a day dedicated to recognizing and advocating for individuals, caregivers and communities impacted by TRD. The campaign is being amplified by leading mental health organizations, including National Alliance on Mental Illness (NAMI), Mental Health America (MHA) and the Depression and Bipolar Support Alliance (DBSA).

TRD is a form of depression distinct from major depressive disorder (MDD) that is estimated to affect approximately 4 million people in the U.S., of whom fewer than 5% are currently on a TRD-indicated treatment.^1,2,3 For many, the journey to recognizing TRD can involve years of cycling through antidepressant treatments that aren't providing meaningful relief, with an impact extending across work, school, relationships and daily life. TRD Awareness Day was established to increase understanding of this condition, help people recognize its signs earlier, and encourage conversations about finding the support they need.

“For too many people living with TRD, the daily challenges of the condition are compounded by feeling misunderstood, judged or even blamed when treatments don’t work,” commented Leah Wentworth, PhD, NAMI’s National Director of Science and Research. “TRD’s impact extends to their families and caregivers as they help their loved ones navigate the condition. As we recognize the first TRD Awareness Day, we have an important opportunity to bring greater visibility to this community, challenge the stigma and misunderstanding surrounding TRD, and remind those affected that they are not alone.”

A new survey found that of those living with TRD, nearly 95% describe themselves as either functioning but struggling, surviving day-to-day or barely getting by.⁴ Further, nearly two in three caregivers say TRD impacts the whole family's social, physical and/or mental health with more than half reporting that caregiving has taken a major toll on their own mental health.⁴ These results underscore how the burden of TRD extends beyond the individual and directly affects caregivers and loved ones, as well. The full report will be shared in a future communication.

“People living with treatment-resistant depression deserve to know that their experiences are recognized, their voices matter and there are people working alongside them to drive meaningful change,” said Steve Levine, M.D., Chief Patient Officer, Compass Pathways. “At Compass, we are deeply committed to the TRD community and to elevating the experiences of patients and caregivers as we work to address the significant unmet needs that remain. By bringing greater awareness to TRD, we can help build a future where people facing this condition feel understood, better supported and more hopeful about what may be possible.”

“When depression continues despite multiple treatment attempts, many people do not realize they may be experiencing TRD,” said Sagar V.Parikh, M.D., FRCPC, DBSA Scientific Advisory Board Vice Chair. “TRD Awareness Day can help both patients and clinicians better understand that this is a distinct condition, separate from major depressive disorder and recognize when it may be time to ask different questions about care strategies. Greater awareness is an important step towards helping people find the support they need and deserve.”

For additional information and resources about TRD, visit the National Alliance on Mental Illness (NAMI), Depression and Bipolar Support Alliance (DBSA) or Mental Health America (MHA).

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 Jersey.

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; 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; 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; 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; 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.

1. Wing V, et al. Poster S97 Contemporary Estimate of the National Prevalence of Treatment-Resistant Depression in the United States. Presented at ADAA 2026.
2. IQVIA.
3. Data on file.
4. Compass Pathways. Survey of Patients and Caregivers Living with Treatment-Resistant Depression. Data on file. 2026.

View source version on businesswire.com: https://www.businesswire.com/news/home/20261014923063/en/