About COMPASS Pathways

COMPASS Pathways plc (COMPASS) operates as a mental health care company. The company is pioneering the development of a new model of psilocybin therapy, in which the company’s investigational COMP360 psilocybin is administered in conjunction with psychological support. COMP360 is the company’s proprietary psilocybin formulation that includes its pharmaceutical-grade polymorphic crystalline psilocybin, optimized for stability and purity. The company’s COMP360 psilocybin therapy - combining COMP360 psilocybin with psychological support from specially trained therapists - could offer a new approach to treatment of serious mental health conditions, including treatment-resistant depression, or TRD, a subset of major depressive disorder, or MDD, anorexia-nervosa and post-traumatic stress disorder, or PTSD. The company’s initial focus is on TRD comprising patients who are inadequately served by the treatment paradigm. In 2018, the company received Breakthrough Therapy designation from the FDA for COMP360 for the treatment of TRD. In 2019, the company completed a Phase 1 clinical trial administering COMP360, along with psychological support, to 89 healthy volunteers. In this trial, the company observed that COMP360 was generally well-tolerated and supported continued progression of Phase 2b studies. The company also demonstrated the feasibility of administering COMP360 psilocybin to up to six healthy participants simultaneously, with 1:1 support. In November 2021, the company announced positive topline results from its Phase 2b clinical trial evaluating COMP360 in conjunction with psychological support for the treatment of TRD. On November 3, 2022, The New England Journal of Medicine, the world’s leading peer-reviewed medical journal, published the positive results from the company’s Phase 2b trial. This is the largest, randomized, controlled, double-blind psilocybin therapy clinical trial completed as of December 31, 2022. The objective of the phase 2b study was to evaluate the efficacy and safety of a single dose of investigational COMP360 psilocybin (25mg or 10mg), compared to 1mg, in patients with TRD. The company commenced its Phase 3 program evaluating its COMP360 psilocybin therapy in TRD. The Phase 3 program is composed of two pivotal trials, each with a long-term follow-up component. The pivotal program design is as follows: Pivotal trial 1 (COMP005) (n=255): a single dose (25mg) monotherapy compared with placebo. This trial is designed to replicate the treatment response seen in the company’s Phase 2b trial (n=233). The company expects top-line data in summer of 2024. Pivotal trial 2 (COMP006) (n= 568): a fixed repeat dose monotherapy using three dose arms: 25mg, 10mg and 1mg. This trial is designed to investigate whether a second dose can increase treatment responders and/or improve responses observed in the company’s Phase 2b trial and explore the potential for a meaningful treatment response from repeat administration of COMP360 10mg. The company expects top-line data by mid-2025. Beyond TRD, the company has ongoing Phase 2 trials in anorexia nervosa and PTSD. The company also provides support to research institutions conducting investigator-initiated studies, or IISs, with COMP360 psilocybin in areas of serious unmet need. These are signal-generating studies that may provide signals for new potential indications that it can explore further and may bring into its development pipeline. For example, the University of California San Diego School of Medicine completed an IIS of COMP360 psilocybin in anorexia nervosa and presented positive data from this study at the Society of Biological Psychiatry Annual Meeting in May 2022. Based on the data generated in this IIS, the company decided to proceed with a Phase 2 clinical trial for anorexia nervosa. Additional IIS studies are underway in a number of other indications, including autism, body dysmorphic disorder, suicidal ideation and severe TRD. Strategy The key elements of the company’s strategy are to advance its Phase 3 registrational program for its investigational COMP360 psilocybin therapy for the treatment of TRD; expand its investigational COMP360 psilocybin therapy into new indications; explore other compounds and therapies to address areas of unmet need; maximize the reach and value of its investigational COMP360 psilocybin therapy by creating a new model for mental health care; and use digital technology to improve access to and the impact of its investigational COMP360 psilocybin therapy. Patents and Other Intellectual and Proprietary Rights Patents and Patent Applications The company’s U.S. Patent No 10,519,175, was granted on December 31, 2019, with claims directed to methods of treating treatment-resistant depression with oral dosage formulations of COMPASS’s high-purity crystalline psilocybin (including COMP360). Three Third Party Observations were previously filed during the pendency of the application, each considered by the Examiner and found to not be a barrier to patentability. A Petition for post-grant review of the patent was filed on February 21, 2020 and was dismissed on the merits on August 20, 2020. On December 15, 2021, Freedom to Operate, Inc., filed a petition for post-grant review of U.S. Patent No. 10,947,257. The patent owner’s response was filed on March 29, 2022. On June 22, 2022, the United States Patent and Trademark Office (USPTO) denied institution of the post-grant review. Freedom to Operate, Inc. filed a request for rehearing on July 22, 2022, and a request for Precedential opinion panel on August 16, 2022. The USPTO Board denied the request for Precedential Opinion Panel (POP) review on February 10, 2023. The USPTO Board has not yet issued a final decision on the request for rehearing. On December 22, 2021, Freedom to Operate, Inc., filed a petition for post-grant review of U.S. Patent No. 10,954,259. The patent owner’s response was filed on April 11, 2022. On June 22, 2022, the USPTO denied institution of the post-grant review. Freedom to Operate, Inc. filed a request for rehearing on July 22, 2022, and a request for Precedential opinion panel on August 16, 2022. The USPTO Board denied the request for Precedential Opinion Panel (POP) review on February 10, 2023. The USPTO Board has not yet issued a final decision on the request for rehearing. The company’s U.K. patent, No GB2571696, was granted in May 2020 with claims directed to large scale manufacture of psilocybin, psilocybin made by said process and formulation comprising psilocybin made by said process. The Intention to Grant was sent in December 2019, and Third-Party Observations were filed in late January 2020, shortly before grant was originally scheduled. Grant of the patent was announced in the Patents Journal on May 27, 2020. This patent has an expiry date of October 8, 2037. On June 11, 2020, Kohn & Associates PLLC filed a request at the U.K. Intellectual Property Office to issue a post-grant opinion on the validity of the patent claims. On April 27, 2021, the agency issued a decision to refuse the request for an opinion finding that it was inappropriate in all the circumstances to issue such an opinion. No appeal to this decision was lodged within the required 28-day period. The company’s U.K. patent, No GB2572023, was granted in June 2020. This patent includes claims covering the company’s crystalline psilocybin (including the form used in COMP360), pharmaceutical formulations of crystalline psilocybin, medical uses of crystalline psilocybin (including for treatment-resistant depression), and a method of manufacturing crystalline psilocybin. The Intention to Grant was sent in December 2019, and Third-Party Observations were filed in late January 2020. A notification of grant was mailed June 23, 2020, and grant was announced in the Patents Journal on July 22, 2020. This patent has an expiry date of June 28, 2038. On August 27, 2020, Freedom to Operate, Inc. filed a request at the U.K. Intellectual Property Office to issue a post-grant opinion on the validity of the patent claims. On July 28, 2021 a non-binding opinion was issued by the agency finding that granted claims 1, 3 and 10-20 are not inventive. The company submitted an amendment to the patent claims and on November 5, 2021 the agency provided notice that the amended specification would be published for opposition in the Patents Journal on December 1, 2021. On December 17, 2021, the agency then issued a decision to not initiate revocation proceedings against the patent. On November 22, 2022, Porta Sophia filed a Third-Party Observation against international patent application WO2022/207746. Trademarks The company has pursued protection for its trademarks across Classes 5, 9, 10, 35, 41, 42, 44 or various combinations thereof. The company’s trademark portfolio includes filings for the COMPASS, COMPASS PATHWAYS, C Design, MYPATHFINDER, and CHANTERELLE marks in the United States, European Union, and the United Kingdom, as detailed in the chart below. The company owns registrations for the COMPASS, COMPASS PATHWAYS, and C Design marks in the United States, European Union, and the United Kingdom; and for the MYPATHFINDER mark in the United Kingdom. Applications are pending for the MYPATHFINDER mark in the United States and European Union; and for the CHANTERELLE mark in the United States. The company also owns trademark registrations and pending applications in other countries. Government Regulation The U.S. Foreign Corrupt Practices Act, to which the company is subject, prohibits corporations and individuals from engaging in certain activities to obtain or retain business or to influence a person working in an official capacity. Research and Development The company’s research and development expenses were $65.1 million for the year ended December 31, 2022. Competition The company faces competition from 501(c)(3) non-profit medical research organizations, including the Usona Institute. History The company was incorporated in June 2020 under the laws of England and Wales. It was formerly known as COMPASS Rx Limited and changed its name to COMPASS Pathways plc in August 2020.