We are here to transform the patient experience in mental health care – and to help some of the millions of people suffering with mental health challenges who have not been helped by existing treatments.

COMPASS was created in 2016 by our co-founders who experienced first-hand just how difficult it can be to find adequate mental health care for a loved one. Six years later, our goal remains the same: to reduce mental health suffering, at scale, through evidence-based approaches.

We are working on a number of mental health illnesses, but our first focus has been on treatment-resistant depression (TRD) because more than 100 million people around the world suffer with TRD. The burden on patients and their families is enormous, but the stigma around mental health challenges means that their stories often go unspoken and unheard.

Thank you to Trish, Dee, and Eric for speaking out about what it’s like to live with TRD.

Dear friends of COMPASS Pathways,

We started COMPASS because we wanted to transform the lives of those suffering with serious mental illness. In 2021, we made significant progress toward this goal.

We are working at a relentless pace, driven by the significant and growing unmet need in mental health care. As Covid recedes from being a global pandemic, the toll on mental health will become even more apparent. There are far too many patients today who have not been helped by existing treatments and who need new options. Our team and research partners are fully committed to developing new therapies to reduce this suffering, at scale. We are also working closely with regulators, payers and health systems, early in the process, to ensure far-reaching and generational impact by making any approved therapy reimbursed and accessible to all who might benefit.

2021 key accomplishments

The highlight of the year was the positive results from our COMP360 psilocybin therapy phase IIb trial in patients suffering with treatment-resistant depression, or TRD. This randomised, controlled, double-blind trial is the largest psilocybin therapy study ever completed. It demonstrated rapid and sustained response for patients receiving a single 25mg dose of COMP360 psilocybin with psychological support. The trial has provided COMPASS with a wealth of data and evidence to support our moving forward into phase III studies, often the final step before submitting a new drug application with the FDA. We are also developing the evidence required by payers to ensure reimbursed access. Regulatory approval must go hand-in-hand with reimbursement so patients can benefit regardless of their ability to pay. Plans for these studies will be finalised over the next few months, following discussion with regulators as part of our ongoing dialogue with them.

We also made important progress in a number of other areas of our business:

• Completed an open-label exploratory study of COMP360 psilocybin therapy in TRD patients who remained on their SSRI antidepressants, which signalled that COMP360 could be used as monotherapy or as adjunctive therapy, providing greater choice for patients and their physicians
• Expanded COMP360 psilocybin development into the indication of post-traumatic stress disorder (PTSD), another area of significant unmet need
• Reported positive results from two investigator-initiated studies using our COMP360 psilocybin, one of which was published in The New England Journal of Medicine
• Appointed several new senior executives, including Dr Guy Goodwin as our Chief Medical Officer, Mike Falvey as our Chief Financial Officer, and Matt Owens as our General Counsel and Chief Legal Officer; welcomed Dr Wayne J Riley to our Board of Directors
• Received new patent grants, bringing our portfolio to 10 patents, covering composition, formulation and method of use
• Expanded development of new psychedelic compounds through growth of our Discovery Center and a partnership with Dr Matthias Grill of MiHKAL GmbH
• Raised an additional $144 million in gross proceeds through an oversubscribed financing, ensuring that we are well-capitalised to proceed with our plans
• Supported important external initiatives such as the British Neuroscience Association’s Scholars programme to promote diversity in neuroscience

2022 milestones

We are expecting another year of great progress, with milestones to include:

• An end-of-phase II meeting with the FDA and launch of our phase III programme of COMP360 psilocybin therapy in TRD
• Publication of COMP360 clinical data in a peer-reviewed journal and at medical conferences
• Progression of our phase II COMP360 psilocybin therapy trial in PTSD
• Launch of COMP360 clinical development programmes in additional indications
• Implementation of our data and technology strategy to support our predictive and preventative model of mental health care
• Scaling up of our therapist training platform to support our phase III programme
• Development of new compounds through our Discovery Center and other collaborations
• Strategic partnerships to accelerate research that will transform mental health care
• Expansion of our Centres of Excellence
• Additional patent grants, further strengthening our commercial exclusivity

Moving into the next phase

As we prepare to move our COMP360 psilocybin therapy into phase III development, COMPASS itself moves into the next phase, with a rapidly growing team of talented and committed people, a strong operational and financial base, and the support of many excellent partners. We continue our work with a keen focus on our values of being compassionate, bold, rigorous and inclusive, and take seriously our responsibility for bringing effective therapies to patients as quickly and safely as possible.

We are all especially grateful to the patients on our trials who have contributed to deepening our understanding of how to help them and countless others as we seek to create a world of mental wellbeing.

With deep appreciation,

Chairman, CEO and Co-founder

In 2021 we made history with the completion of the world’s largest psilocybin therapy clinical trial. This was one of many highlights in a year in which we took a giant leap forward in our work to transform mental health care.

*TRD = treatment-resistant depression, *PTSD = post-traumatic stress disorder

Positive results from COMP360 phase IIb clinical trial

In 2021, we completed the world’s largest psilocybin trial – a randomised, controlled, double-blind phase IIb study of COMP360 psilocybin, given in conjunction with psychological support from specially trained therapists, to 233 patients.

The topline data showed a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. Patients also showed improvements in other areas including quality of life measures.

*TRD = treatment-resistant depression

Launch of phase II study of COMP360 psilocybin therapy for PTSD

We have launched a phase II study into our second clinical indication, PTSD, another area of high unmet need.

This multi-centre, fixed-dose open-label study will enrol 20 participants to evaluate the safety and tolerability of COMP360 psilocybin therapy in people who suffer with PTSD resulting from trauma experienced as adults. The study will begin at The Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London.

*PTSD = post-traumatic stress disorder

Building a pipeline of new compounds through expanded preclinical research

In addition to the preclinical work at our Discovery Center in the US, we are partnering with Dr Matthias Grill of MiHKAL GmbH in Switzerland on a research project to develop new product candidates. The substances being explored include a variety of psychedelic and empathogenic compounds, some of which are prodrugs – pharmacologically inactive compounds which are metabolised inside the body to produce an active drug.

We have made good progress with screening and developing new compounds through our expanding preclinical programme, and plan to move some of these into clinical development within the next two years.

Founding Supporter of the British Neuroscience Association’s Scholars programme

We are delighted to be a Founding Supporter of the British Neuroscience Association (BNA)’s inaugural Scholars programme, set up to support students from under-represented ethnic groups to thrive in neuroscience, and build a supportive community through networking opportunities, bursaries and mentorship. This sponsorship is part of our ongoing commitment to equity, diversity and inclusion (EDI) in our industry and our workplace.

We are deeply grateful to all the patients involved in our clinical trials and the therapists who support them – our company exists to transform mental health care, and we couldn’t do it without them.

Last year, we developed our charters: our commitments to how we will work with patients and therapists, developed with their input and reflecting their needs. Our charters are one way in which we hold ourselves accountable to working in a responsible and ethical way, with the people whose lives are being impacted by our clinical trials.

One year later, we’ve reflected on the ways in which we’ve made progress towards meeting these commitments, and the work that there is still to do. Our whole team is focused on doing more, every day, as we move closer to achieving our goal of accelerating patient access to evidence-based innovation in mental health.

Warm regards,

Ekaterina
Ekaterina Malievskaia MD, Chief Innovation Officer and Co-founder

Our commitments to patients

We will report on our progress towards achieving these commitments annually, and update them to reflect patient needs, as we work to bring psilocybin therapy to everyone who might benefit from it.

Our commitments to therapists

We will report on our progress towards achieving these commitments annually, and update them to reflect therapist needs, as we work to bring psilocybin therapy to everyone who might benefit from it.