Compass Pathways Archives - Page 2 of 2 - Green Market Report

Debra BorchardtDecember 1, 2021
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COMPASS Pathways plc (Nasdaq: CMPS)  announced further results from its groundbreaking phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression (TRD). Compass said that additional analyses of primary and secondary endpoints validated topline findings and provided more insights into safety data. The objective of the trial was to find the appropriate dose for a larger, pivotal phase III program, which COMPASS said it expects to begin in 2022.

The study investigated three doses of COMP360 psilocybin (1mg, 10mg, 25mg) in 233 patients with TRD. The results showed that a single 25mg dose of COMP360 demonstrated a highly statistically significant and clinically relevant reduction in depressive symptom severity after three weeks, with rapid and durable treatment response. The 25mg group vs the 1mg group showed a -6.6 difference on the MADRS* depression scale at week 3 (p<0.001). In the 25mg group, 36.7% (29 patients) showed response* at week 3 and 29.1% (23 patients) were in remission* at week 3. Furthermore, at the end of the trial at week 12, 24.1% (19 patients) were sustained responders*. Additional analyses of primary and secondary endpoints have supported these results.

Professor Guy Goodwin, Chief Medical Officer, COMPASS Pathways, said: “Our additional analyses underline the robustness of our findings that a single high dose of COMP360 psilocybin, given in conjunction with psychological support, led to a rapid and sustained response for many patients. This phase IIb study was designed to determine the optimal COMP360 dose for our phase III programme, evaluating safety and efficacy at the primary endpoint at week 3. Additionally, we observed consistent improvement in measures of anxiety, positive and negative affect, quality of life, daily functioning, cognition, and self-reported depression. We believe this could make a tremendous difference to patients suffering with treatment-resistant depression, who have few options available to them. Remember, a quarter of the 25mg group maintained response, as measured by the MADRS, at 12 weeks after a single administration with no other antidepressant medication. This finding in itself is unprecedented.”

Analyses of exploratory measures including anxiety, self-reported depression, positive and negative affect, and functioning, showed greater improvements for patients receiving a 25mg dose of COMP360 psilocybin compared with those receiving a 1mg dose after three weeks, both with psychological support. Further analysis is ongoing and full trial results will be submitted for publication in a peer-reviewed journal. The data will be reviewed with regulators early next year.

Sidney Zisook MD, Director of the University of California San Diego Residency Training Program, a Distinguished Professor of Psychiatry at UCSD, and a Principal Investigator on the trial, said, “Many of the participants in this study had suffered for years with severe and crippling depressive disorders despite multiple treatment trials with traditional antidepressant medications and therapies. To see so many experience a robust and sometimes persisting response – and a new, brighter, more positive attitude – during the course of the study, was immensely gratifying and hopeful.”


Debra BorchardtAugust 11, 2021
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Compass Pathways plc (Nasdaq: CMPS) reported its financial results for the second quarter of 2021 and gave an update on recent progress across its business. Compass reported a net loss for the three months ending June 2021 was $17.5 million, or $0.44 loss per share, (after including non-cash share-based compensation expense of $1.9 million) compared with $16.2 million, or $1.65 loss per share, during the same period in 2020 (after including non-cash share-based compensation expense of $9.7 million).

The company is sitting comfortably on a pile of cash. Compass reported cash and cash equivalents of $316.3 million as of June 2021 versus $190.3 million as of December 2020. “In May 2021, we closed an underwritten public offering, including the full exercise of the underwriters’ greenshoe option, and received net cash proceeds of approximately $154.8 million, after deducting underwriting discounts and commissions and other offering expenses.”

Compass also reported that the research and development (R&D) expenses were $11.4 million for the quarter versus $6.7 million during the same period in 2020. Of this increase, $4.7 million reflected increased development activities and $1.4 million related to hiring additional staff, as COMPASS progresses its COMP360 psilocybin therapy in TRD, and continues to explore additional indications and therapeutic approaches. There was a reduction of $1.7 million in non-cash share-based compensation expense compared with the same period in the prior year

George Goldsmith, Chairman, CEO, and Co-founder, COMPASS Pathways, said, “We have completed psilocybin therapy administration in our COMP360 phase IIb trial, a significant milestone in our journey to bring new therapies to patients suffering with treatment-resistant depression. This is the largest trial ever conducted in psilocybin therapy, and it was done amid the lockdowns and challenges of the COVID pandemic. We are well-positioned for recruitment to phase III, pending results from the phase IIb study, which are expected later this year.”

The company reported that its general and administrative (G&A) expenses were $8.2 million for the quarter versus $11.0 million during the same period in 2020. The decrease was attributable to reductions of $6.1 million and $0.5 million respectively in non-cash share-based compensation and legal and professional fees, offset against an increase of $1.8 million and $2.0 million respectively in personnel expenses and facilities and other expenses.

Psilocybin Update

Compass noted that its Phase IIb clinical trial of COMP360 psilocybin therapy for TRD was close to completion and the company said it was on track to report top-line data by end of 2021. COMP360 psilocybin therapy has now been given to 233 patients, exceeding 216 targets. A dose-finding study comparing 25mg and 10mg of COMP360 psilocybin with 1mg, given in conjunction with psychological support from specially trained therapists. It is the world’s largest psilocybin therapy trial, taking place in 22 sites across 10 countries.


StaffMay 13, 2021
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3min14740

COMPASS Pathways plc (Nasdaq: CMPS) reported its financial results for the first quarter of 2021. The net loss was $12.7 million, or $0.35 loss per share (after including non-cash share-based compensation expense of $1.7 million), versus $8.6 million, or $0.93 loss per share, during the same period in 2020 (after including non-cash share-based compensation expense of $1.7 million)

Research & development (R&D) expenses were $6.9 million versus $5.2 million during the same period in 2020. Compass said that $1.4 million reflected increased development activities, including hiring additional staff, as COMPASS progresses its COMP360 psilocybin therapy in TRD, and continues to explore additional indications and therapeutic approaches

George Goldsmith, Chairman, CEO and Co-founder, COMPASS Pathways, said, “Our recent financing gives us additional resources to work even faster and to expand our efforts, grow our team, and focus on developing new indications, new compounds and new technologies, building on our leadership position in psilocybin therapy and mental health care. Far too many people are suffering with mental health challenges today. We are focused on developing evidence-based therapies that can make a difference and be accessible to as many patients as possible who might benefit. The COMP360 data published in the New England Journal of Medicine showed promising signals in a small investigator-initiated study. We are approaching the completion of our phase IIb trial of COMP360 psilocybin therapy for treatment-resistant depression, and on track to report data by the end of the year.”

The company still has plenty of cushion as it develops its products. Pro-forma cash and cash equivalents were $179.5 million as of March 31, 2021, compared with $190.3 million on December 31, 2020. On May 4, 2021, following the end of the reporting period, COMPASS completed a public offering of 4,000,000 American Depositary Shares at a price of $36.00 per ADS for total gross proceeds of $144 million.

Granted Patents

Two new patents were granted by the US Patent and Trademark Office for Compass. The patents cover oral formulations of COMPASS’s synthetic psilocybin in the treatment of MDD and Compass’s high-purity crystalline psilocybin (including the form used in COMP360), pharmaceutical formulations containing crystalline psilocybin, and methods of treating MDD with crystalline psilocybin. Compass’s innovation has now been recognized with six granted patents, including three in the US, two in the UK, and one in Germany


Debra BorchardtMarch 9, 2021
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Psychedelic medicine company Compass Pathways plc (Nasdaq: CMPS) reported its financial results for the fourth quarter and year-end 2020 and gave an update on recent progress across its business. Compass delivered a net loss for the quarter ending in December 2020 was $18.8 million, or $0.52 loss per share versus last year’s net loss of $7.6 million, or $0.90 loss per share for the same period in 2019. The earnings beat the average analyst estimate according to Yahoo Finance which was for a loss of $1.05. The stock was trading slightly higher and was lately selling at $39. The average price target for the stock is $65.

For the full year, Compass reported a net loss of $60.3 million, or $3.55 loss per share (after including non-cash share-based compensation expense of $18.0 million) versus 2019’s net loss of $19.6 million, or $2.62 loss per share, during the same period in 2019 (after including non-cash share-based compensation expense of $3.3 million).

“Mental health is an urgent crisis and this has only been exacerbated by the COVID-19 pandemic,” said George Goldsmith, Chairman, CEO and Co-founder, Compass Pathways. “At COMPASS we remain committed to transforming mental health care and helping patients who are suffering and aren’t helped by existing treatments. Our phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression is actively recruiting and we plan to report data from this trial at the end of the year. We are also continuing preclinical research into new indications, new compounds and new technologies, working with partners through our Centre of Excellence, our Discovery Center, and a number of investigator-initiated studies, as well as developing a strong team.”

Expenses

The company noted that research & development expenses (R&D) were $4.5 million for the fourth quarter versus $4.6 million during the same period in 2019. For the full year, R&D expenses were $23.4 versus $12.6 million in 2019, reflecting increased investment in the ongoing phase IIb COMP360 psilocybin therapy clinical programme for TRD.

General and administrative expenses (G&A) were $7.0 million for the fourth quarter versus $2.8 million in 2019. Of the increase, $0.5 million was related to share-based compensation expenses. G&A expenses were $28.0 million for the 12 months ended 31 December 2020, compared with $8.6 million during the same period in 2019. Of this increase, $10.2 million was related to share-based compensation expenses.

The company listed the following business highlights:

Business highlights

  • Continued progress with phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression (TRD)
    – On track to report data end of 2021
    – New site added in London, UK, bringing trial to 22 sites in 10 countries
  • Signal-generating, exploratory psilocybin therapy research underway in a range of indications
    – COMPASS has the right to exclusively license new IP generated through these investigator-initiated studies
  • Launch of first Centre of Excellence at Sheppard Pratt, Baltimore
    – Centres of Excellence are research facilities and innovation labs that COMPASS anticipates will model the ”clinic of the future”, showcasing the most advanced thinking in science, therapy, technology and design
  • Expansion of Discovery Center in the US
    – Discovery Center expanded beyond initial sponsored research agreement with University of the Sciences (Philadelphia, PA) to include collaborations with world-leading scientists from laboratories at UC San Diego, School of Medicine, and Medical College of Wisconsin, in a virtual network

Debra BorchardtNovember 12, 2020
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5min18110

Psychedelic company Compass Pathways plc (Nasdaq: CMPS) reported its financial results for the third quarter of 2020 and gave an update on recent progress across its business. The company reported a net loss of $16.6 million and essentially no income as the company is focused on research at this time. The company has cash of $196.5 million as of 30 September 2020, which is expected to fund operations into 2023.

George Goldsmith, Chairman, CEO and Co-founder, Compass Pathways, said, “This has been a significant quarter, with an IPO that gives us the funds needed to advance our mission and transform mental health care. Recent hires for the company build further important expertise within our strong leadership team, including in data science and digital health, which will be core to the future of mental health care. We remain fully focused on execution of our phase IIb trial investigating our COMP360 psilocybin therapy for treatment-resistant depression and, with scientific partners in our recently established Drug Discovery Center, are also evaluating the potential of early stage compounds to address mental health challenges.”

Expenses

R&D expenses were $6.9 million for the quarter versus $3.1 million during the same period in 2019. The change was primarily related to increased activities associated with the company’s ongoing development of COMP360, increased share-based compensation, and other increases in personnel costs to support the development of COMP360. G&A expenses were $6.6 million for the quarter versus $3.1 million during the same period in 2019. $2.1 million of the increase was related to share-based compensation expenses, and there were also increases in legal and professional fees, personnel and consulting expenses, and facilities costs.

Company Update

Compass said in a statement, “We have continued to make steady progress with our phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression. We are opening a new trial site in Berlin, Germany, this month, bringing our trial to 21 sites in 10 countries. While the COVID-19 pandemic has impacted our trial, our plan to report data from this trial in late 2021 remains unchanged.”

On 5 August 2020, the company entered into a sponsored research agreement with the University of the Sciences in Philadelphia, PA, to establish a Drug Discovery Center. The Center is exploring and developing optimized psychedelic and other early-stage compounds targeting the 5HT2A receptor, a receptor in the brain that is recognized as a promising target in the treatment of mental health illnesses.

In July 2020, Compass was granted its second UK patent, adding to our US patent and German utility model, and including claims covering crystalline psilocybin, pharmaceutical formulations, medical uses, and a method of manufacturing. The US patent, granted in December 2019, was the subject of a petition for post-grant review, filed on 21 February 2020; the petition was dismissed on the merits on 20 August 2020.

New Team Members

Our team has continued to expand and we have been pleased to welcome several new colleagues to our leadership team during the quarter and post-period. Linda McGoldrick joined our board of directors in September 2020, bringing healthcare and life sciences experience from a range of public and private companies, and non-profit organizations, including Financial Health Associates International, Zillion Inc, Veos plc, and Kaiser Permanente International. In 2018, Linda was appointed by the Governor of Massachusetts to serve on the state’s Health Information Technology Commission. Greg Ryslik PhD joined us on 9 November 2020 as Senior Vice President, Data Science, Machine Learning and Digital Health Research, and Stephen Schultz will join us on 1 December 2020 as Senior Vice President, Investor Relations. Greg is a data scientist and AI (artificial intelligence) executive; he is an instructor at Stanford Continuing Studies and has held senior positions at Mindstrong and at Tesla Inc. Stephen has more than 30 years’ experience in investor relations and joins us from GW Pharmaceuticals; he has previously held senior roles at Amarin Corporation, Acusphere, and Shareholder.com. Earlier in the quarter, Steve Levine MD joined us as Vice President, Patient Access; Steve was formerly Founder and CEO at Actify Neurotherapies. Sarah Bateup was appointed Head of Therapy Research and Training, having previously been Chief Clinical Officer at Ieso Digital Health.


William SumnerOctober 7, 2020
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Psychedelic drugs like psilocybin are a game changer in the world of mental health sciences. There is a growing body of evidence that suggests psilocybin has the potential to help treat anxiety, depression, and post-traumatic stress disorder (PTSD). As scientific interest in psilocybin grows, so too does the attention of investors; many of whom cannot help but see the market similarities between psychedelics, pharmaceuticals, and the cannabis industries.

Indeed, the functional non-psychedelic and gourmet mushroom markets as a whole is poised for explosive growth over the next few years. By 2024 the market is expected to grow to $34.3 billion in sales according to ResearchAndMarkets.com. Recognizing the huge opportunities in these other fungi markets, dozens of companies have sprung up hoping to cash in on the psychedelic mushroom space, like Compass Pathways (NASDAQ: CMPS).

As one of the more high profile companies investigating psilocybin-based therapies, Compass has been enjoying the investor spotlight for the last several months, especially after recently announcing an upsized IPO of more than $127 million. With high profile backers like PayPal billionaire Peter Thiel, Compass has become the company du jour of the psychedelic space, but regulatory uncertainty and issues of scaling still haunt the company’s path to market.

As evidenced by the decades-long disconnect between state and federal cannabis laws, both lawmakers and regulators are slow to embrace substances that carry the social stigma of the War on Drugs, even when there is a large body of evidence suggesting therapeutic potential.

Even if Compass is able to bring a substance to market, it will be subject to heavy restrictions and a long scheduling process, which will significantly stymie any market rollout. In their IPO filing, the company admits as much.

“In addition, the scheduling process may take significantly longer than the 90-day deadline set forth in the CSA, thereby delaying the launch of our investigational COMP360 psilocybin therapy in the United States,” reads the filing.

Further, standing in the way of Compass’ dreams of market primacy is the issue of scaling. The company’s primary source of psilocybin comes from laboratory synthesis, which is prohibitively expensive. Due to the high cost of synthetic psilocybin production, Compass charges their customers anywhere between $7,000-$10,000 USD per gram, averaging out to around $13.20 per milligram.

In comparison, whole-mushroom extraction is significantly cheaper, costing around $0.76 per gram to extract psilocybin, assuming the source of the mushrooms are from a black market dealer. Now, if you can legally produce your own mushrooms, the costs only continues to decline.

Currently, the only company in the world that can legally produce pharmaceutical-grade psilocybin from whole-mushroom extraction is Mydecine Innovations Group (CSE: MYCO). Equipped with a Health Canada Schedule 1 Controlled Drugs and Substances Dealer’s Licence, Mydecine can not only produce whole-mushroom psilocybin extractions, but they can also transfer, sell, and export the substance as well. 

While Compass seems to be mired in regulatory uncertainty south of the Canadian border, Mydecine is quietly conducting, in collaboration with the Dutch Royal Army, the world’s first clinical trials into the efficacy of psilocybin in treating Post-Traumatic Stress Disorder.  Leading these efforts is a science team with a surprisingly deep bench of experts, including a seven-time Nobel Prize nominee and the former chair of the NATO research group on military mental health training.

Though Compass may have a head start, Mydecine has a much clearer path to market; due in no small part to the lack of regulatory uncertainty surrounding Mydecine’s efforts and the company’s ability to produce psilocybin at significantly lower prices. With a solid foundation moving forward, Mydecine seems poised for growth. The question is, will investors take notice?

 


Debra BorchardtSeptember 1, 2020
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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%.

Psilocybin Treatments

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.”
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