The UK-based mental health company known for its psychedelic treatments, Compass Pathways has filed to go public this week. The company said it plans to list its American depositary shares on the Nasdaq under the ticker “CMPS”. The company reported total net losses of $13.2 million, $19.6 million and $24.8 million, respectively, for the fiscal years ended December 31, 2018 and December 31, 2019 and the six months ended June 30, 2020.
The company has raised $116 million so far. As of June 30, 2020, it had an accumulated deficit of $62.4 million. Its largest shareholder is Atai Life Sciences, which owns 29% of the stock. Other large shareholders include founders George Goldsmith and Ekaterina Malievskaia each with 16.5% of the company. Entities affiliated with Peter Thiel own 7.5%.
The company is known for its pioneering the development of a new model of psilocybin therapy, in which psilocybin is administered in conjunction with psychological support. “Our initial focus is on treatment-resistant depression, or TRD, a subset of major depressive disorder, or MDD, comprising patients who are inadequately served by the current treatment paradigm. The company noted in its filing that early signals from academic studies, using formulations of psilocybin not developed by us, have shown that psilocybin therapy may have the potential to improve outcomes for patients suffering with depression, with rapid reductions in depression symptoms and effects lasting up to six months, after administration of a single high dose.” The company noted that the depression market is seen as a $200 billion market.
“We have developed a proprietary, high-purity polymorphic crystalline formulation of psilocybin, COMP360. In 2019, we completed a Phase I clinical trial administering COMP360, along with psychological support, to 89 healthy volunteers, the largest randomized controlled clinical trial with psilocybin therapy to date. In this trial, we observed that COMP360 was generally well-tolerated. We are currently evaluating COMP360 in conjunction with psychological support in a Phase IIb trial and we plan to report data from this trial in late 2021.”
Use Of Proceeds
The company said it will use the proceeds raised to fund clinical trials, therapist training and other activities to support the development of its investigational COMP360 psilocybin therapy through completion of all ongoing trials through the end of Phase II meetings with the FDA. Compass will also fund research and clinical development activities related to its investigational COMP360 psilocybin therapy to support the progression of COMP360 as a therapy for other neuropsychiatric indications and further our mechanistic understanding of psilocybin. In addition, the money will be used to fund general business development activities, including strategic investments.
Phase 2 trials
Compass is currently conducting a randomized controlled Phase IIb clinical trial in 216 patients suffering with TRD, in 20 sites across North America and Europe. This dose-finding trial is investigating the safety and efficacy of COMP360 combined with psychological support, for the treatment of TRD, and aims to determine the optimal dose of COMP360, with three doses (1mg, 10mg, 25mg) being explored. The primary endpoint of this clinical trial is to evaluate the efficacy of COMP360, as assessed by the change in the Montgomery-Åsberg depression rating scale, or MADRS, a widely accepted scale for depression that has been used as a primary endpoint in pivotal trials of other depression treatments. This trial has been designed to capture a statistically significant reduction in MADRS. Compass plans to report data from this trial in late 2021.
“We are using digital technology in this Phase IIb trial, including an online portal to help patients prepare for their psilocybin experience, and a web-based “shared knowledge” interactive platform to complement therapist training. We are also collecting digital phenotyping information through the measurement of human-smartphone interactions. After the trial, these data will be compared with information collected from validated psychiatric scales, such as MADRS, to develop potential digital applications to help anticipate relapse of depression. In the future, we plan to expand our research into additional digital technologies to complement and augment our therapies.”