COMPASS Pathways PLC (NASDAQ: CMPS)

COMPASS Pathways PLC (NASDAQ: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health to help people live happier and healthier lives. The company aspires to create the next generation of psychedelic therapies based on a safe and effective approach that optimizes patient outcomes. COMPASS is motivated by the need to find better ways to help and empower people suffering with mental health challenges who are not helped by existing therapies. The company is pioneering the development of a new model of psilocybin therapy, in which psilocybin is administered in conjunction with psychological support. Its focus is on treatment-resistant depression (TRD), a subset of major depressive disorder (MDD) comprising patients who are inadequately served by the treatment paradigm. It has developed a proprietary, high-purity polymorphic crystalline formulation of psilocybin, COMP360.

COMPASS is evaluating its COMP360 psilocybin therapy through rigorous research and clinical trials, as well as extensive engagement with regulatory agencies. The company’s research, development, and work with regulatory agencies in countries across North America and 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 TRD. COMPASS has also launched a sponsored clinical research program in post-traumatic stress disorder (PTSD).

Patients’ needs are at the heart of the company’s purpose, and they are the reason behind every decision made. From care delivery to how therapies are integrated into health systems, COMPASS always focuses on patient perspectives as the company charts a path toward medical access, irrespective of ability to pay. The company believes patients deserve a treatment approach that ensures quality, safety and efficacy. COMPASS is generating data that ensure regulatory bodies, payers, and health systems can objectively assess the role that COMP360 psilocybin therapy could play in today’s mental health care. The company is headquartered in London, with offices in New York and San Francisco.

Clinical Trials

COMP360 has been designated a Breakthrough Therapy by the U.S. Food and Drug Administration (FDA) for TRD. COMPASS recently announced results of a Phase 1 study showing the feasibility of administering COMP360 psilocybin to up to six healthy participants simultaneously, with 1-to-1 support. The study, peer-reviewed and published in The Journal of Psychopharmacology under the title “The effects of psilocybin on cognitive and emotional functions in healthy participants: results from a phase I CQ, randomized CQ, placebo-controlled trial involving simultaneous psilocybin administration and preparation,” was conducted by the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London in 2019. The results also showed there were no short nor long term detrimental effects on thinking patterns or processing of emotions.

The study looked at the effects of two doses of COMP360 psilocybin (10mg and 25mg), compared with placebo, in 89 healthy male and female adult volunteers. The participants were randomized in a 1:1:1 ratio to receive 10mg COMP360 (n=30), 25mg COMP360 (n=30), or placebo (n=29). The investigational drug was administered simultaneously to up to six participants, who all received 1-to-1 psychological support from trained therapists throughout the session, which lasted about six hours. The study involved a 12-week follow up period. There were no serious adverse events, and COMP360 psilocybin was found to be well-tolerated with no clinically relevant negative effects on cognitive function.

The company also has completed a Phase 2b clinical trial of psilocybin therapy for TRD in 22 sites across Europe and North America. This was the largest randomized, controlled, double-blind psilocybin therapy clinical trial ever conducted. The topline data showed a statistically significant 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. COMPASS is also running a Phase 2 clinical trial of COMP360 psilocybin therapy for PTSD.

Market Outlook

According to a report from ResearchAndMarkets, the global psychedelic drugs market is expected to grow from $3.21 billion in 2021 to a value of $6.33 billion in 2026, a CAGR of 14.5 percent during the forecast period. Market growth is due to a large unmet need for mental health treatment driving the adoption of psychedelic drugs. North America is predicted to remain the largest region in the psychedelic drugs market due to a surge of clinical trials, massive investments, regulatory support and widespread public awareness. The continent accounts for half of the revenue in the global psychedelic drugs market and should be worth $3.184 billion by the end of the forecast period. The strong presence of companies and ongoing clinical trials are also expected to be drivers of the regional market.

Management Team

George Goldsmith is chairman, CEO and co-founder of COMPASS. His early training and experience involve a blending of cognitive psychology, clinical psychology and computer science. The first company he founded was a pioneer in collaborative software and was acquired by Lotus Development. He later created TomorrowLab, and eventually joined McKinsey as CEO of TomorrowLab@McKinsey. In 2002, George founded Tapestry Networks, an organization committed to improving leadership performance and effective governance. He still serves as Tapestry Networks’ Non-Executive Chairman.

Ekaterina Malievskaia, M.D., is Chief Innovation Officer and co-founder of COMPASS. She earned her medical degree from St. Petersburg Medical Academy in Russia, and then moved to the U.S. for her Internal Medicine residency. She worked in private practice, academic medicine and public health for more than 15 years and was a Clinical Instructor of Medicine at Mount Sinai School of Medicine and a Research Professor at City University of New York. She founded COMPASS Pathways with her husband, George Goldsmith, in 2016.

Anne Benedict is Chief People Officer at COMPASS. Her experience includes 10 years of HR consulting at Mercer, organizational development roles at Disney-ABC, nine years of talent management and people responsibilities in marketing services at Interpublic Group, and three years leading People at Infor, a global enterprise software company with 17,000 employees in over 60 countries. She graduated magna cum laude with a bachelor’s degree in science/psychology from McGill University and holds a master’s degree in industrial/organizational psychology from the University of Waterloo.