2020 was a momentous year, in which fundamental assumptions of how we live and work were challenged on a global scale. We also saw an unprecedented appreciation of the role that science, medicines and vaccines play in improving public health. And a greater understanding of how medicine and vaccine developers can work closely with regulators to get products clinically tested and approved in record times. While many of us long for the way things were before the pandemic, I hope some of these systemic changes in how we bring innovation to patients are here to stay.

Attention has been rightly focused on physical health aspects of COVID-19. However, many people are now also recognising the burden on mental health, arising from the fear, stress, economic uncertainty and social isolation that we have experienced in the last year. The pandemic has had an impact on us all, not least on those who have been directly affected by the disease including patients, families and frontline workers. The effects are likely to be felt for months and years after we learn how to live alongside COVID.

A mental health care crisis

Even before the pandemic, mental health care was in crisis. At COMPASS we talk about the fact that “everyone has a story”, whether that’s about themselves or a family member, friend or colleague. Mental health care today works for some but is not good enough for far too many people. Our company has a strong sense of purpose – we are committed to bringing evidence-based innovation to more people and to finding ways to help all those who are suffering.

As a team, we have been fortunate to be able to carry on with our work throughout the last year, seeing each other every day, albeit on a screen, and continuing to collaborate with people around the world in clinical trial sites, research institutions and other organisations. Our team spirit has shone through organised events such as the COMPASS Summer and Winter Games (in compensation for the postponed Olympics), comedy nights and quizzes, and a fundraising campaign for a group of London homeless charities. More than a third of the company has joined since we’ve been working remotely but apart from not knowing everyone’s height, we are getting to know each other quickly, perhaps helped by the gallery window into everyone’s home.

Importantly, we have been making continued progress on our phase IIb clinical trial of COMP360 psilocybin therapy in treatment-resistant depression (TRD), now in 22 sites in 10 countries, with data expected at the end of the year. We have been extremely impressed by the creativity and commitment of everyone involved in minimising the disruption from COVID across all our trial sites.

Our first clinical trial is in TRD because of the huge unmet need in this area and the significant impact of this illness on people’s lives. We have also been expanding our COMP360 psilocybin therapy programme into other areas of need, through signal generating investigator-initiated studies which are exploring indications including anorexia, body dysmorphic disorder, bipolar type II disorder, and major depressive disorder in cancer patients. If promising signals are found in these studies, we will consider moving them into phase II development programmes.

We also have an active preclinical programme, which completed over 20 new studies in 2020. In addition, our newly expanded Discovery Center is exploring optimised psychedelic compounds. We envision some of these projects progressing to clinical development programmes over the next few years, again focused in areas of unmet medical need.

Our work in psilocybin therapy takes an integrative approach, with the combination of medicine, psychological support and digital technologies. We have steadily added capability in our therapist training area so we can train and support the therapists required for our phase III programme. Ultimately, we aim to create a precise, predictive and preventative model of care for patients who are not served by the current system. With your support, we have now raised over $250 million since our initial financing in the summer of 2017. This is enabling us in our mission to accelerate patient access to evidence-based innovation.

Transforming the patient experience in mental health care

Transforming the patient experience in mental health care means that we must work closely with leaders in clinical care. In addition to working with academic centres on investigator-initiated studies, we have established the first in a planned network of Centres of Excellence, where we can research and prototype the delivery of this new model of care in psychiatry. All of this must be grounded in a deep understanding of the needs and interests of patients. We have been privileged to work with the Depression and Bipolar Support Alliance (DBSA), listening to and learning from their groups of patients, or peers, as they are called. Our commitment to broad patient access inspired our support for the Grady Trauma Project in Atlanta, a research study into mental health care needs and attitudes to psychedelic therapy, in marginalised communities.

We are a mental health care company, but our first work is in developing psilocybin therapy, because that’s where we see the greatest promise for patients. Others agree and several moves towards psilocybin legalisation and access have recently taken place in the US and Canada. In Oregon, for example, a measure was passed to develop legal ways of providing access to psilocybin therapy. We have always been clear that the regulatory route – rather than the legislative route – is the best way to assure patients of the safety, efficacy and quality of any medicine. This route is also the most likely way to have a therapy be reimbursed, making it accessible to more people.

Over the last year we have been inspired by so many people – health workers, scientists, vaccine developers, patients, our own families and friends. I have been inspired by our COMPASS team who bring our values – compassionate, bold, rigorous, inclusive – to life every day. I’d like to thank them for everything they do. This report reflects their work and their dedication to patients and a world of mental wellbeing.

We are all grateful for the support of our investors who make this work possible.

Warm regards,

Financial highlights

^* includes $13.5 million of losses on foreign exchange and change in the fair value of convertible notes, offset against a benefit of $4.2 milion from R&D tax credits

^** includes $1.2 million of losses on foreign exchange and change in the fair value of convertible notes, offset against a benefit of $2.7 million from R&D tax credits

Business highlights

Lockdowns haven’t held us back in the last year. We took big steps forward in fundraising, strengthening our team, executing our clinical trial programme, progressing patient access strategies, and beginning to develop new compounds, indications and technologies. Here are some highlights.

We are a mental health care company

Our mission is to accelerate patient access to evidence-based innovation in mental health. We focus our efforts on those who are not helped by current treatments. Our first priority is to bring COMP360 psilocybin therapy to some of the millions of people who suffer with treatment-resistant depression (TRD).

We are pioneering the development of this therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. The US Food and Drug Administration (FDA) has designated COMP360 a Breakthrough Therapy for TRD, and we are conducting a phase IIb clinical trial in 22 sites across Europe and North America.

We are also exploring other areas of unmet need in mental health, beyond TRD. We want to reduce the underlying stigma associated with mental health. By understanding that “everyone has a story” and putting the patient at the heart of what we do, we can transform mental health care and the patient experience of it.

We live by our values of being compassionate, bold, rigorous and inclusive. Many of us at COMPASS have been personally touched by mental health challenges and know that existing care options are not good enough. We are determined to reduce the personal and economic burden of mental health suffering, as we take strides towards our vision of a world of mental wellbeing.

Our primary focus remains on psilocybin therapy for treatment-resistant depression (TRD), the convergence of a highly promising medicine with an area of huge unmet medical need.

Alongside psilocybin therapy for TRD, we are beginning to build a pipeline of new indications, new compounds and new technologies. In this effort we are fortunate to be collaborating with knowledgeable partners who share our values and our goals. We are working together to improve patient experience and patient outcomes, through access to evidence-based innovation.

Here are a few of our partners and some of the things we’re working on.

Lars Wilde, President and Chief Business Officer, COMPASS Pathways