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COMPASS Pathways announces publication in Frontiers in Psychiatry of paper on therapist training programme for psilocybin therapy

COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, has shared details of its comprehensive and rigorous therapist training programme for psilocybin therapy, in a paper jointly written with a group of academic researchers, and published in Frontiers in Psychiatry today. The programme sets out a formal and scalable methodology for psychological support in psilocybin therapy. It is currently being used to train therapists taking part in COMPASS’s phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression, as approved by the US Food and Drug Administration (FDA), as part of COMPASS’s Investigational New Drug (IND) application.

In psilocybin therapy, patients are given a dose of psilocybin, a psychedelic substance, in conjunction with psychological support from specially trained therapists. COMPASS developed the therapist training programme alongside leading experts in mental health and psychedelic research, including William A Richards (Johns Hopkins Bayview Medical Center, US), Elizabeth Nielson (NYS Psychiatric Institute, NYU School of Medicine, US), Riikka Ajantaival (Clinical Research Institute, Helsinki University Central Hospital, Finland), Peter Gasser (private practice, Switzerland), Sara J Tai (University of Manchester, UK), Brian D Richards (Johns Hopkins Bayview Medical Center, Sheppard and Enoch Pratt Hospital, and Aquilino Cancer Center, US), and Frederick Reinholdt (King’s College London, UK). The programme uses a new and manualised approach drawing from evidence-based psychotherapeutic approaches, and currently comprises four components: an online learning platform; in-person training; applied clinical training; and ongoing individual mentoring and professional development.

In previous psilocybin studies, the approach to psychological support often varied between research sites, making it difficult to replicate and distinguish the specific effects of psilocybin from concurrent therapeutic interventions. Equally, training in the provision of psychological support had not been defined and evaluated. This manualised training programme begins to address this gap and is the start of a process that will continue to be refined and adapted as clinical trials of psilocybin therapy progress.

Dr William A Richards, a psychologist and research affiliate in the Psychiatry Department of the Johns Hopkins University School of Medicine, Bayview Medical Center, and a co-author of the paper, said, “The psychological support is an integral element of psilocybin therapy and must be provided by trained therapists. The development of a structured and formalised training programme aims to ensure we deliver psilocybin therapy in a way that considers physical and psychological safety, with consistently high quality support.”

Therapists who participated in the training reported that the combination of didactic and experiential learning helped them to build conceptual understanding and develop their skills in the therapeutic approach. From the programme feedback, the clinical training and engagement in participant care, under the guidance of experienced therapists, were considered to be the most beneficial and challenging aspects of the training.

Ekaterina Malievskaia, Chief Innovation Officer and Co-founder, COMPASS Pathways, said, “Psilocybin therapy has the potential to make a difference to millions of people suffering with mental health challenges, and our priority is to develop evidence-based innovations that are safe and effective for patients. High quality clinical training for therapists is an essential part of this. Our training programme is the result of early and ongoing collaboration with many experts and we are grateful for all their contributions. We will continue to evolve our training programme as we progress COMP360 psilocybin therapy through clinical trials. We hope that this first step encourages collaboration among therapist training providers, as we work towards bringing psilocybin therapy to all who might benefit.”

About COMPASS Pathways

COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we are currently conducting a phase IIb clinical trial of psilocybin therapy for TRD in 22 sites across Europe and North America. We are headquartered in London, UK, with offices in New York, US. Our vision is a world of mental wellbeing. www.compasspathways.com

Availability of other information about COMPASS Pathways

Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com),  and on social media (LinkedIn), including but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “anticipate”, “believe”, “contemplate”, “estimate”, “predict”, “potential”, “continue” and “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond COMPASS’s control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

These risks, uncertainties, and other factors include, among others, the risk that benefits of our methodology of psychological support in psilocybin therapy may be less effective than we believe, that preclinical and clinical development is lengthy and uncertain, and therefore our preclinical studies and clinical trials may be delayed or terminated, or may never advance to or in the clinic, and those risks and uncertainties described under the heading “Risk Factors” in COMPASS’s Prospectus filed with the US Securities and Exchange Commission (SEC) on 21 September 2020 and in subsequent filings made by COMPASS with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, COMPASS disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on COMPASS’s current expectations and speak only as of the date hereof.

Enquiries:

Media: Tracy Cheung, tracy@compasspathways.com, +44 7966 309024
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401-290-7324

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COMPASS Pathways plc to participate in Canaccord Genuity’s New Paradigms and Treatment Approaches in Mental Health Conference

COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that members of its management team will participate in Canaccord Genuity’s New Paradigms and Treatment Approaches in Mental Health Conference. George Goldsmith, Chairman, CEO and Co‑founder, will deliver the opening day keynote at 12:30pm ET on 3 February.

An audio webcast of the keynote presentation will be available on the “Events” page of the Investors section of the COMPASS website at https://ir.compasspathways.com/news-events/events. A replay will be available for 30 days following the event.

About COMPASS Pathways

COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we are currently conducting a phase IIb clinical trial of psilocybin therapy for TRD, in 21 sites across Europe and North America. We are headquartered in London, UK, with offices in New York, US. Our vision is a world of mental wellbeing. www.compasspathways.com

Enquiries:

Media: Tracy Cheung, tracy@compasspathways.com, +44 7966 309024
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401-290-7324

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COMPASS Pathways establishes Centre of Excellence with Sheppard Pratt to accelerate research and improve patient experience in mental health care

COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, is establishing its first Centre of Excellence in collaboration with The Sheppard Pratt Institute for Advanced Diagnostics and Therapeutics in Baltimore, Maryland, United States.

The Centre of Excellence will model the “clinic of the future”, showcasing the best thinking in science, therapy, technology, and design. Working as a research facility and innovation lab, it will generate evidence to shape therapy models in mental health care, train and certify therapists, conduct clinical trials including proof-of-concept studies, and prototype digital solutions to improve patient experience. The first wave of research will focus on COMPASS’s investigational COMP360 psilocybin therapy, which comprises administration of COMP360 psilocybin with psychological support from specially trained therapists.

Sheppard Pratt is one of the world’s leading research institutes in mental health and one of the top psychiatric hospitals in the United States. It is a leader in clinical service delivery, supporting more than 70,000 patients annually in its local community, as well as across 42 states and 19 countries. The Centre of Excellence will be led by Scott Aaronson MD, Director of Clinical Research at Sheppard Pratt, a distinguished fellow of the American Psychiatric Association and a fellow of the American College of Psychiatrists.

The Centre of Excellence will be built on the Sheppard Pratt Towson campus and will include at least four state-of-the-art psychedelic therapy rooms, as well as facilities for research and training. In addition to a capital investment to support the design and building work, COMPASS will fund research studies into psilocybin therapy and other therapies, led by Dr Aaronson.

Dr Aaronson said, “The Centre of Excellence will enable us to carry out new research in the use of psilocybin therapy for a range of mental illnesses, such as depression, obsessive-compulsive disorder and post-traumatic stress disorder, among others. We are already using COMP360 psilocybin in two investigator-initiated studies in psilocybin therapy for severe treatment-resistant depression and for bipolar type II depression. We can see the enormous potential that this therapy could have on the lives of millions of people with mental health conditions around the world.”

Harsh K Trivedi MD, MBA, President and CEO of Sheppard Pratt, said, “We are delighted to collaborate with COMPASS on their first Centre of Excellence. There is a tremendous unmet need to provide access to high-quality mental health care, and forging this relationship allows us to transform the delivery of care on a global scale. With great vision and continued investment, we have the potential to revolutionise mental health care treatment and bring innovative solutions to patients as quickly as possible.”

George Goldsmith, CEO and Co‑founder, COMPASS Pathways plc, said, “We want to transform mental health care, which today is not good enough for far too many people. Sheppard Pratt has a long history of excellence in clinical service delivery and commitment to its community of patients. Our Centres of Excellence, beginning with this centre led by the distinguished team at Sheppard Pratt, will help to accelerate our combined work so that we can bring evidence-based innovation, on a large scale, to the people who need it the most.”

About COMPASS Pathways

COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we are currently conducting a phase IIb clinical trial of psilocybin therapy for TRD, in 21 sites across Europe and North America. We are headquartered in London, UK, with offices in New York, USA. Our vision is a world of mental wellbeing. www.compasspathways.com

About Sheppard Pratt

Sheppard Pratt is the largest private, non-profit provider of mental health, substance use, developmental disability, special education, and social services in the United States. A nationwide resource, Sheppard Pratt provides services across a comprehensive continuum of care, spanning both hospital and community-based resources. Since its founding in 1853, Sheppard Pratt has been innovating the field through research, best practice implementation, and a focus on improving the quality of mental health care on a global level. Sheppard Pratt has been consistently ranked as a top national psychiatric hospital by US News & World Report for 30 years.

Forward-looking statements

This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding COMPASS’s expectations of its future working relationship with Sheppard Pratt, expectations of plans for and the success of its first Centre of Excellence, and expectations about the efficacy of COMP360. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to COMPASS’s relationship with Sheppard Pratt, the ability of Sheppard Pratt to undertake or advance its research projects, and those risks and uncertainties described under the heading “Risk Factors” in COMPASS’s Prospectus filed with the US Securities and Exchange Commission (SEC) on 21 September 2020 and in subsequent filings made by COMPASS with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, COMPASS disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on COMPASS’s current expectations and speak only as of the date hereof.

Availability of other information about COMPASS

Investors and others should note that COMPASS communicates with its investors and the public using the company website (www.compasspathways.com), the investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that COMPASS posts on these channels and websites could be deemed to be material information. As a result, COMPASS encourages investors, the media, and others interested in COMPASS to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on COMPASS’s investor relations website and may include additional social media channels. The contents of COMPASS’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Media enquiries:

Tracy Cheung, tracy@compasspathways.com, +44 7966 309024

Amy Lawrence, amy@compasspathways.com, +44 7813 777919

Tamara Chumley, tchumley@sheppardpratt.org, +1 410 938 3157

Investors enquiries:

Stephen Schultz, stephen.schultz@compasspathways.com, +1 401-290-7324

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COMPASS Pathways plc to participate in HC Wainwright and ICR investor conferences

COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that members of its management team will participate in two investor conferences during the week of 11 January 2021.

George Goldsmith, Chairman, CEO and Co‑founder, and Lars Wilde, President, Chief Business Officer, and Co‑founder, will be participating in a fireside chat available on demand from 11 to 14 January in conjunction with the HC Wainwright BioConnect 2021 Conference.

George Goldsmith and Lars Wilde will also present a business update and hold a fireside chat at 12:15 pm ET on 14 January at the Westwicke Healthcare Day at the ICR Conference 2021.

Audio webcasts of the fireside chats will be available on the “Events” page of the Investors section of the COMPASS website at https://ir.compasspathways.com/news-events/events. A replay of events will be available for 30 days following the event.

About COMPASS Pathways

COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we are currently conducting a phase IIb clinical trial of psilocybin therapy for TRD, in 21 sites across Europe and North America. We are headquartered in London, UK, with offices in New York, USA. Our vision is a world of mental wellbeing.

Enquiries:

Media: Tracy Cheung, tracy@compasspathways.com, +44 7966 309024
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401-290-7324

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COMPASS Pathways News | December 2020 Issue

Dear friends,

It goes without saying that 2020 has been a challenging year for everyone. The devastation caused by the COVID-19 pandemic will leave an impact for years to come – on the economy, on employment, on our physical health, and on our mental health.

We were in a global mental health crisis even before COVID arrived, and it is more important than ever that we find a way to deliver better outcomes in mental health care for more people. At COMPASS, we are grateful that we have been able to continue our work throughout the year, with our highly engaged team working remotely, as well as collaboration, support and flexibility from so many people including partners, researchers, and investors. As I reflect on this year, I want to express my gratitude for everyone who has helped us to make progress towards our goal of transforming mental health care.

Unmet need in mental health care

In September this year we became a public company, listing our stock on Nasdaq and raising $146.6 million. Most of this money will be used to fund our clinical development, including our clinical trials of COMP360 psilocybin therapy and our therapist training activities, as well as our R&D programmes, and work on digital technologies. We are grateful to all our past, existing and new investors – your support reflects an understanding of the growing unmet need in mental health care, and allows us to advance our research with continued pace and rigour.

Public sentiment has also been caught by the desperate need for better mental health care. This was clearly demonstrated in November in the US state of Oregon, where voters passed Measure 109 to begin a process to legalise psilocybin therapy for medical use. We share the same long-term goals of Measure 109: to provide options for the many people who suffer with mental health challenges for whom existing treatments don’t work. However, we believe that psilocybin therapy needs to be approved by medical regulators, with evidence generated in large-scale clinical trials, so that it can be assessed on safety, efficacy and quality, and made accessible to all who might benefit, through national and local health systems.

COMP360 psilocybin therapy trial for treatment-resistant depression

A huge thank you to our clinical trial teams in North America and Europe who have worked so hard to overcome the challenges of running a clinical trial during a global pandemic. The safety of patients and our teams is always our highest priority, and this has guided all our discussions over when and how to reopen sites that were closed during the initial lockdowns in March 2020. We have been able to safely resume our phase IIb clinical trial, with the use of new procedures and equipment, including clear plastic masks.

We recently welcomed our 21st trial site, The Charité in Berlin, bringing our research through this trial to 10 countries in North America and Europe.

Our research partners

We have a bold ambition to transform mental health care. We know we cannot do this alone, and are fortunate to work with researchers across the world to accelerate the development of innovative treatments and bring them to patients. Thank you to all our research partners for your continued collaboration.

In August we 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 optimised psychedelic and other early-stage compounds targeting the 5HT2A receptor – one of the receptors in the brain that is recognised as a promising target in the treatment of mental health challenges.

We are also providing funding and support to the Aquilino Cancer Center at Adventist HealthCare Shady Grove Medical Center, in Rockville, MD, which has begun the first clinical trial of psilocybin therapy with simultaneous administration and one-on-one patient support to treat depression in cancer patients.

Last month we joined the Psychiatry Consortium, an international collaboration of medical research charities and pharmaceutical companies focused on the challenge of identifying and validating novel drug targets for mental health illnesses. We will work alongside Psychiatry Consortium members and academic partners to advance research projects, providing support through access to funding, expertise, and commercialisation know-how.

Our energetic and mission-driven team

We couldn’t do any of this without our amazing team and our board, both made up of talented and dedicated individuals, who have been simply outstanding during a challenging and extremely busy year.

In recent months, we have welcomed Linda McGoldrick as non-Executive Director; Greg Ryslik as Senior Vice President, Data Science, Machine Learning and Digital Health Research; Steve Levine as Vice President of Patient Access; Sarah Bateup as Head of Therapy Research and Training; and Stephen Schultz as Senior Vice President, Investor Relations. COMPASS is now a team of more than 60 people and continuing to grow. We are ably supported by a wider network of suppliers, partners and advisers, and we are proud and grateful to work with all of you.

From left to right: Linda McGoldrick, Greg Ryslik, Steve Levine, Sarah Bateup, and Stephen Schultz 

Thank you to everyone who has continued to support us, observe our work, or send us messages. We look forward to sharing more progress with you in 2021, as we work together to realise our vision of a world of mental wellbeing.

We wish you and your loved ones all the very best for the holidays and the New Year.

Warm regards,
Ekaterina

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COMPASS Pathways plc announces financial results for third quarter 2020

Highlights include $146.6 million IPO, continued progress with phase IIb psilocybin therapy clinical trial, strengthened board and leadership team, and launch of Drug Discovery Center


Third quarter and post-period highlights:

  • Completed upsized initial public offering (IPO) on Nasdaq, raising $146.6 million
  • Continued to progress phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression
  • Strengthened board and leadership team with appointments of Linda McGoldrick as non-Executive Director; Greg Ryslik as Senior Vice President, Data Science, Machine Learning and Digital Health Research; and Stephen Schultz as Senior Vice President, Investor Relations
  • Established Drug Discovery Center with the University of the Sciences in Philadelphia, PA

Conference call today at 1.00pm GMT (8.00am ET)

COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported its financial results for the third quarter of 2020 and gave an update on recent progress across its business.

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.”

Corporate highlights

In September 2020, we completed our IPO of 8,625,000 American Depositary Shares (ADSs) representing 8,625,000 ordinary shares at a price of $17.00 per ADS. This included 1,125,000 additional ADSs issued upon the exercise in full by the underwriters of their option to purchase additional ADSs. The total gross proceeds from the offering were $146.6 million. All ADSs sold in the offering were offered by COMPASS. The ADSs began trading on the Nasdaq Global Select Market on 18 September 2020.

Business highlights

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. We are working closely with our trial sites to carefully assess the ongoing COVID-19 situation and will always put the safety of patients and our teams above everything else.

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 organisations, 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.

On 5 August 2020, we 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 optimised psychedelic and other early stage compounds targeting the 5HT2A receptor, a receptor in the brain that is recognised as a promising target in the treatment of mental health illnesses.

In July 2020, we were granted our 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. Our 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.

We continue to work with a number of academic and other partners to accelerate research or to provide our COMP360 psilocybin for use in their independent studies. We are providing funding and support to the Aquilino Cancer Center at Adventist HealthCare Shady Grove Medical Center, in Rockville, MD, which recently launched the first clinical trial of psilocybin therapy with simultaneous administration and one-on-one patient support to treat depression in cancer patients.

Earlier this month, we joined the Psychiatry Consortium, an international collaboration of medical research charities and pharmaceutical companies focused on the challenge of identifying and validating novel drug targets to address the unmet therapeutic needs of people living with mental health conditions. We will work alongside Psychiatry Consortium members and academic partners to advance research projects, providing support through access to funding, expertise, and commercialisation know-how. The Psychiatry Consortium seeks project proposals from the global psychiatric research community via biannual open calls for applications – the next call for applications will open in January 2021.

Financial highlights

Cash position: We held cash and cash equivalents of $196.5 million as of 30 September 2020, compared with $67.6 million at 30 June 2020. This is expected to fund operations into 2023.

Research & development expenses: R&D expenses were $6.9 million for the three months ended 30 September 2020, compared with $3.1 million during the same period in 2019. The change was primarily related to increased activities associated with our ongoing development of COMP360, increased share-based compensation, and other increases in personnel costs to support the development of COMP360.

R&D expenses were $18.8 million for the nine months ended 30 September 2020, compared with $8.0 million during the same period in 2019. The change was primarily related to increased activities associated with our ongoing development of COMP360, increased share-based compensation, and other increases in personnel costs to support the development of COMP360.

General and administrative expenses: G&A expenses were $6.6 million for the three months ended 30 September 2020, compared with $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.

G&A expenses were $21.1 million for the nine months ended 30 September 2020, compared with $5.9 million during the same period in 2019. $9.7 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.

Other income (expense), net: Other income (expense), net was a net expense of $3.1 million for the three months ended 30 September 2020, compared with a net income of $0.6 million during the same period in 2019. $4.3 million of the increase in net expense related to foreign exchange losses.

Other income (expense), net was a net expense of $1.5 million for the nine months ended 30 September 2020, compared with a net income of $1.9 million during the same period in 2019. $3.3 million of the increase in net expense related to foreign exchange losses.

Net loss: The net loss for the three months ended 30 September 2020 was $16.7 million, or $1.30 loss per share, (after including non-cash share-based compensation expense of $5.2 million), compared with $5.7 million, or $0.73 loss per share, during the same period in 2019 (after including non-cash share-based compensation expense of $1.8 million).

The net loss for the nine months ended 30 September 2020 was $41.5 million, or $3.90 loss per share, (after including non-cash share-based compensation expense of $16.6 million), compared with $12.0 million, or $1.68 loss per share, during the same period in 2019, (after including non-cash share-based compensation expense of $2.5 million).

Conference call

The COMPASS Pathways management team will host a conference call at 1.00pm GMT (8.00am ET) on 12 November 2020. The call can be accessed by dialling (833) 665-0659 from the United States, +1 (914) 987-7313 internationally, and 0800 028 8438 from the UK, followed by the conference ID: 9377988.

The call will also be webcast live on the investors section of the COMPASS Pathways website (ir.compasspathways.com). The webcast will be archived for 30 days.

 

About COMPASS Pathways

COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we are currently conducting a phase IIb clinical trial of psilocybin therapy for TRD, in 21 sites across Europe and North America. We are headquartered in London, UK, with offices in New York, USA. Our vision is a world of mental wellbeing. www.compasspathways.com

 

Availability of other information about COMPASS Pathways

Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (Linkedin), including but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

 

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “anticipate”, “believe”, “contemplate”, “estimate”, “predict”, “potential”, “continue” and “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond COMPASS’s control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

These risks, uncertainties, and other factors include, among others: preclinical and clinical development is lengthy and uncertain, and therefore our preclinical studies and clinical trials may be delayed or terminated, or may never advance to or in the clinic; and those risks and uncertainties described under the heading “Risk Factors” in COMPASS’s Prospectus filed with the US Securities and Exchange Commission (SEC) on 21 September 2020 and in subsequent filings made by COMPASS with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, COMPASS disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on COMPASS’s current expectations and speak only as of the date hereof.

 

Enquiries

COMPASS Pathways
Tracy Cheung, tracy@compasspathways.com, +44 7966 309024
Amy Lawrence, amy@compasspathways.com, +44 7813 777919

Westwicke (for investor enquiries)
Stephanie Carrington, stephanie.carrington@westwicke.com, +1 646 277 1282

Posted on

COMPASS Pathways joins the Psychiatry Consortium in a collaboration to accelerate drug discovery in mental health care

COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, has joined the Psychiatry Consortium, an international collaboration to accelerate drug discovery and development in areas of urgent, unmet medical need.

The Psychiatry Consortium, managed by Medicines Discovery Catapult, is a strategic collaboration of leading medical research charities and pharmaceutical companies focusing on the challenge of identifying and validating novel drug targets to address the unmet therapeutic needs of people living with mental health conditions. COMPASS Pathways will work alongside Psychiatry Consortium members and academic partners to advance research projects, providing support through access to funding, expertise, and commercialisation know-how. The Psychiatry Consortium seeks project proposals from the global psychiatric research community via biannual open calls for applications – the next call for applications will open in January 2021.

Dr Gary Gilmour, Director of Preclinical Research, COMPASS Pathways, said, “The scale of today’s mental health crisis is huge, and is getting bigger every day. The Psychiatry Consortium is bringing leading experts and resources together to speed up and reinvigorate the drug discovery process, and we are proud to be part of it. By working towards a common goal, we can bring evidence-based innovations to the people who need them, as quickly as possible.”

About COMPASS Pathways

COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we are currently conducting a phase IIb clinical trial of psilocybin therapy for TRD, in 20 sites across Europe and North America. We are headquartered in London, UK, with offices in New York, USA. Our vision is a world of mental wellbeing. www.compasspathways.com

About the Psychiatry Consortium

The Psychiatry Consortium is a strategic collaboration of leading medical research charities and pharmaceutical companies focusing on the challenge of identifying and validating novel drug targets to address the unmet therapeutic needs of the people living with mental health conditions. The Psychiatry Consortium is managed by Medicines Discovery Catapult and supported by Wellcome. www.psychiatryconsortium.org

Forward-looking statements

This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding COMPASS’s expectations of its future working relationship with Psychiatry Consortium. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to the ability of Psychiatry Consortium to undertake or advance its research projects. Forward-looking statements contained in this announcement are made as of this date, and COMPASS undertakes no duty to update such information except as required under applicable law.

Enquiries

COMPASS Pathways
Tracy Cheung, tracy@compasspathways.com, +44 7966 309024
Amy Lawrence, amy@compasspathways.com, +44 7813 777919

Westwicke (for investor enquiries)
Stephanie Carrington, stephanie.carrington@westwicke.com, +1 646 277 1282

Posted on

COMPASS Pathways plc to announce third quarter 2020 financial results on 12 November 2020

COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that it will release financial results for the third quarter ended 30 September 2020, and provide an update on recent business developments, on 12 November 2020.

The management team will host a conference call at 1.00pm GMT (8.00am ET) on 12 November. The call can be accessed by dialling (833) 665-0659 from the United States, +1 (914) 987-7313 internationally, and 0800 028 8438 from the UK, followed by the conference ID: 9377988.

The call will also be webcast live on the Investors section of the COMPASS Pathways website. The webcast will be archived for 30 days.

 

About COMPASS Pathways

COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we are currently conducting a phase IIb clinical trial of psilocybin therapy for TRD, in 20 sites across Europe and North America. We are headquartered in London, UK, with offices in New York, USA. Our vision is a world of mental wellbeing. www.compasspathways.com

 

Enquiries:

COMPASS Pathways
Tracy Cheung, tracy@compasspathways.com, +44 7966 309024
Amy Lawrence, amy@compasspathways.com, +44 7813 777919

Westwicke (for investor enquiries)
Stephanie Carrington, stephanie.carrington@westwicke.com, +1 646 277 1282

Posted on

COMPASS Pathways plc to participate in Berenberg and Evercore investor conferences

COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that members of its management team will participate in two upcoming online investor conferences.

On 13 November, COMPASS will be holding 1:1 investor meetings at the Berenberg US CEO Conference.

On 2 December, George Goldsmith, Chairman, CEO and Co‑founder, COMPASS Pathways, will host a fireside chat at 8.00am ET, at the Evercore ISI 3rd Annual HealthCONx Conference. COMPASS will also be holding 1:1 investor meetings at the conference from 1-2 December.

About COMPASS Pathways

COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we are currently conducting a phase IIb clinical trial of psilocybin therapy for TRD, in 20 sites across Europe and North America. We are headquartered in London, UK, with offices in New York, USA. Our vision is a world of mental wellbeing. www.compasspathways.com

Enquiries

COMPASS Pathways
Tracy Cheung, tracy@compasspathways.com, +44 7966 309024
Amy Lawrence, amy@compasspathways.com, +44 7813 777919

Westwicke (for investor enquiries)
Stephanie Carrington, stephanie.carrington@westwicke.com, +1 646 277 1282

Posted on

COMPASS Pathways plc to ring Nasdaq Stock Exchange opening bell in celebration of its successful $146.6 million IPO

COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, announced that it will ring the Nasdaq Stock Exchange opening bell today, in celebration of its recently completed initial public offering.

George Goldsmith, CEO and Co-founder, COMPASS Pathways, will be joined by members of the COMPASS team for the virtual ceremony, which will begin at approximately 9.20am Eastern Time, and can be viewed live at https://livestream.com/nasdaq/live and on the Nasdaq MarketSite Tower at 43rd Street and Broadway, New York, NY. The bell ringing will take place at 9.30am Eastern Time, signifying the start of the day’s trading session.

George Goldsmith said, “I am honoured to be ringing the Nasdaq opening bell on behalf of everyone at COMPASS Pathways. We are on a mission to transform mental health care and I know that every member of our 60-person team shares our strong sense of purpose and our determination to reduce the personal and economic burden of mental health suffering.

“We have a big vision. We see a world of mental wellbeing, a world in which mental health isn’t simply the absence of mental illness but the ability to flourish. Our first priority is to bring our psilocybin therapy to some of the millions of people who suffer with treatment-resistant depression. We want to develop new models of care, supported by evidence from clinical trials and in the real world.”

 

About COMPASS Pathways

COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we are currently conducting a phase IIb clinical trial of psilocybin therapy for TRD, in 20 sites across Europe and North America. We are headquartered in London, UK, with offices in New York, USA. Our vision is a world of mental wellbeing. www.compasspathways.com

 

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “anticipate”, “believe”, “contemplate”, “estimate”, “predict”, “potential”, “continue” and “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond COMPASS’s control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

These risks, uncertainties, and other factors include, among others: preclinical and clinical development is lengthy and uncertain, and therefore our preclinical studies and clinical trials may be delayed or terminated, or may never advance to or in the clinic; and those risks and uncertainties described under the heading “Risk Factors” in COMPASS’s Prospectus filed with the US Securities and Exchange Commission (SEC) on 21 September 2020 and in subsequent filings made by COMPASS with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, COMPASS disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on COMPASS’s current expectations and speak only as of the date hereof.

 

Enquiries

COMPASS Pathways
Tracy Cheung, tracy@compasspathways.com, +44 7966 309024
Amy Lawrence, amy@compasspathways.com, +44 7813 777919

Westwicke (for investor enquiries)
Stephanie Carrington, stephanie.carrington@westwicke.com, +1 646 277 1282