Welcome to our Annual Review 2023

Dear Friends of Compass Pathways,

Urgent need

A year ago, I noted how privileged I felt to join Compass at such a crucial juncture; my enthusiasm for our mission has only deepened since then.

Our dedication to innovation in mental health care is more vital than ever, as millions continue to grapple with mental health challenges–we all know someone affected, including many of us personally.

Momentum increasing

The pressing need for improved care options continues to spur momentum for psychedelic treatments.

We’ve witnessed significant strides in the regulatory landscape, signalling a shift towards increasing acceptance. Notable developments include the US Food and Drug Administration (FDA) issuing draft guidance for the clinical investigation of psychedelic drugs and the European Medicines Agency updating guidelines to incorporate psychedelic therapy for depression. These regulatory advancements reflect a growing acknowledgment of the therapeutic potential of psychedelics.

We also welcome Lykos Therapeutics’ submission of a landmark New Drug Application for their post-traumatic stress disorder (PTSD) therapy to the FDA, a noteworthy milestone in mental health care. More broadly, we saw continued public interest in the potential of psychedelics which underscores the urgency and importance of our work.

In August, our success in securing up to $285 million in funding was a highly significant achievement. Not only did this bolster our financial position, but it also attracted sophisticated healthcare and biotech investors who recognise the promise of our rigorous efforts. We view this new investment as validation of our evidence-based approach to developing psychedelic medicines.

Evidence pursued

The establishment of the Centre for Mental Health Research and Innovation in collaboration with King’s College London (KCL) and the South London and Maudsley NHS Foundation Trust in November marked a tangible milestone in our journey, at the same time initiating our phase 3 trials in the UK. This unique partnership serves as a focal point for COMP360 research, offering a space for psilocybin treatment sessions, therapist training, and the development of digital technologies to support personalised care.

Our global phase 3 programme, the largest ever study of psilocybin treatment, continues to progress. To facilitate the conduct of our studies, we’ve introduced three new digital products aimed at streamlining workflows and enhancing data collection. Additionally, comprehensive therapist training ensures that our clinical trial execution remains rigorous.

Evidence generated

The publication of further data from our phase 2b study in the Journal of Affective Disorders and the study of COMP360 psilocybin treatment alongside SSRI antidepressants in the prestigious journal Neuropsychopharmacology underscores our commitment to advancing the field. Beyond treatment-resistant depression (TRD), our research extends to other mental health disorders, and we were pleased to see promising data published from investigator-initiated studies in cancer-related depression (May), anorexia nervosa (July), and bipolar type II depression (December).

Access

As we await study results, we’ve begun preparations for potential regulatory approval and subsequent commercialisation.

In 2023 we published papers focusing on optimising psilocybin treatment outcomes and addressing current terminology limitations. Additionally, we published several papers exploring the application of generative AI and large-language models to analyse psychological support sessions, aiming to enhance care provision. Embracing digital innovation is pivotal in our journey towards precision medicine in mental health and underscores our commitment to improving outcomes. Expanding digital tools and partnerships remains essential as we progress towards commercialisation.

We’re proud to have worked with Lykos Therapeutics to establish a new CPT III code with the American Medical Association, for in-person monitoring and intervention services during administration of psychedelic treatments. This is a vital step to enable reimbursement from payers in the US, which is critical to ensuring broad and equitable access.

Partnerships finalised in late 2023 and announced in early 2024 with healthcare providers like Greenbrook TMS and Hackensack Meridian Health aim to optimise care delivery and ensure broad access to COMP360, if approved.

The strengthening of our leadership team with the appointments of Teri Loxam as Chief Financial Officer and Daphne Karydas to our Board of Directors brings invaluable expertise to our organisation. Their extensive experience in the pharmaceutical and biotechnology sectors will be instrumental as we navigate the complexities of drug development and commercialisation.

The establishment of our Diversity, Equity, and Inclusion (DEI) Council reflects our commitment to fostering a more diverse and inclusive workplace. By focusing on various workstreams, including digital accessibility, therapist diversity, and patient engagement, the council has helped accelerate our progress towards a more equitable organisation and a treatment model that is more diverse, inclusive, and equitable.

Looking to the future

2024 will be a critical year for Compass as we anticipate our first pivotal data announcement. We look forward to primary endpoint data from our first phase 3 study in TRD and results from our phase 2 open-label study in PTSD.

Strong phase 3 data would keep us on a path to seek regulatory approval of COMP360 psilocybin treatment, potentially transforming mental health care for those failed by current standards.

Amidst these developments, our unwavering commitment to addressing the urgent need for improved mental health care remains paramount and drives us forward.