COMPASS Pathways : To our community –

Happy New Year!

As we embark on a new year, we wanted to take a moment to thank you for your ongoing commitment to our company, reflect on our accomplishments as a community, and share our vision for the future.

Our mission

At COMPASS Pathways, our mission is to accelerate patient access to evidence-based innovation in mental health to help people live happier and healthier lives. We aspire to create the next generation of psychedelic therapies based on a safe and effective approach that optimises patient outcomes. With that as our guiding focus, we are evaluating and developing psychedelic therapies, starting with our COMP360 psilocybin therapy, through rigorous research and clinical trials, as well as extensive engagement with regulatory agencies.

Our research, development, and work with regulatory agencies in countries across North America, Europe and in the UK, are driven by the need to establish COMP360 psilocybin therapy as a safe, validated, and effective way to address mental health conditions in the 21st century, starting with treatment-resistant depression (TRD). We have also launched a sponsored clinical research programme in post-traumatic stress disorder (PTSD).

Patients' needs are at the heart of our purpose, and they are the reason behind every decision we make. From care delivery to how therapies are integrated into health systems, we always focus on patient perspectives as we look to chart a path towards medical access, irrespective of ability to pay. Our patients deserve a treatment approach that ensures quality, safety, and efficacy. Hence, it is our responsibility to take the ethical and practical path to generate the data that ensures regulatory bodies, payers, and health systems can objectively assess the role that COMP360 psilocybin therapy could play in today's mental health care landscape.

Looking back at what we've achieved

We are grateful for the progress we've made together. To date, our ongoing in-depth conversations with payers and regulatory agencies are allowing us to develop a detailed road map for global regulatory approval and reimbursement requirements.

In 2021, we made history. We completed the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever done with our phase IIb study of COMP360 psilocybin therapy for TRD, and showed a rapid and sustained response for patients receiving a single 25mg dose of COMP360 psilocybin with psychological support. In line with the way we always do things here at COMPASS, the trial was designed with input from multiple regulatory agencies and payers. This study is an important step in the development of what appears to us to be a true clinical breakthrough.

We have also completed an exploratory study of COMP360 psilocybin therapy in combination with SSRI antidepressant use, with results showing comparable treatment outcomes to those seen in patients in our phase IIb trial (in which patients were withdrawn from their SSRI before they received COMP360 psilocybin therapy). This challenges the widely-held belief that the use of SSRI medication together with psilocybin could interfere with psilocybin's therapeutic effect and suggests that COMP360 psilocybin therapy could be available to a broader group of patients including those who have difficulty transitioning off antidepressants.

As mentioned, we also successfully launched our clinical research programme in PTSD - a major milestone for COMPASS during the year.

We have taken the bold step of subjecting our business model to the rigours of the public markets, becoming the first company working with psychedelics to list successfully on NASDAQ. Over the past 15 months, we have earned our place in NASDAQ's biotech index fund. We have developed a patent portfolio based on our innovative advancements. This portfolio is grounded in COMP360, our purified psilocybin drug candidate and continues to expand as we evaluate the nuances of therapeutic interactions with patients using a multitude of different data sources and digital approaches. We firmly believe this strategy will enable us to transform and accelerate patient access to evidence-based innovation in mental health care, particularly in areas of high unmet medical need. We have faith in the extensive technical and legal expertise of patent offices around the world that have reviewed our advancements. We stand behind the innovation we have developed and the science behind our patents.

Looking ahead

In 2022, we will continue to work towards achieving our mission. We are laser focused on applying scientific rigour and extensive research to develop, through the regulatory system, our product candidates to help ensure quality, safety, efficacy, and availability to every patient in need. We will:

• Launch phase III of our COMP360 psilocybin therapy clinical trial programme for TRD
• Continue to support leading researchers in their initial exploration of how our therapy might help patients suffering with anorexia nervosa, bipolar depression, body dysmorphic disorder, major depression associated with life-threatening illnesses, and suicidality
• Develop partnerships and Centres of Excellence with health systems
• Continue to build digital solutions and refine our therapy model

We will pursue these critical endeavours using an evidence-based approach that is rooted in data and can be regulated, reimbursed, and accessible to those who need it most.

Our team at COMPASS looks forward to a promising future. It is our hope that through our work, we will move closer to a world where COMP360 psilocybin therapy and other innovative, life affirming therapies are an integrated part of mental health care systems everywhere. A major step closer to a world of mental wellbeing.

Thank you. May the new year carry us onward and upward!

Warm regards,

George Goldsmith
CEO and Co-founder, COMPASS Pathways