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COMPASS Pathways plc announces financial results and business highlights for the second quarter 2021

  • Phase IIb COMP360 psilocybin therapy trial for treatment-resistant depression (TRD) close to completion; on track to report data by end of 2021
  • Partnership being developed with leading UK institutions to accelerate psychedelic research and develop new models of mental health care in the UK
  • Guy Goodwin appointed Chief Medical Officer and Danielle Schlosser appointed Senior Vice-President, Clinical Innovation
  • “Everyone has a story: talking about mental health” podcast launched to eliminate stigma and open up dialogue
  • Conference call today at 1:00pm UK (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 second quarter 2021 and gave an update on recent progress across its business.

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.”

Mr Goldsmith added, “We continue to invest in the expansion of our portfolio through new indications for psilocybin therapy and the discovery of new psychedelic compounds. We expect to see data this year from the investigator-initiated study of COMP360 psilocybin therapy in cancer patients, currently underway at Maryland Oncology Hematology at the Aquilino Cancer Center, and plan to begin new studies in other indications over the next few months.”

Business highlights

  • Phase IIb clinical trial of COMP360 psilocybin therapy for TRD close to completion
    • COMP360 psilocybin therapy has now been given to 233 patients, exceeding 216 target
    • On track to report top-line data by end of 2021
    • Dose-finding study comparing 25mg and 10mg of COMP360 psilocybin with 1mg, given in conjunction with psychological support from specially trained therapists
    • World’s largest psilocybin therapy trial, taking place in 22 sites across 10 countries
  • Continued investment in the expansion of the COMPASS portfolio, exploring new indications through investigator-initiated studies (IISs) and new compounds through our Discovery Center
    • IIS at Maryland Oncology Hematology at the Aquilino Cancer Center, in the US, for COMP360 psilocybin therapy in cancer, due to finish and report data this year
  • Partnership being developed to accelerate psychedelic research and develop new models of mental health care in the UK
    • Memorandum of Understanding signed with South London and Maudsley NHS Foundation Trust and the Institute of Psychiatry, Psychology and Neuroscience at King’s College London
    • Partnership intended to include research into areas of unmet need such as depression, post-traumatic stress disorder (PTSD) and anorexia nervosa
    • COMPASS is part of the working group that helped to establish mental health as one of the seven critical missions of the UK Government’s new life sciences strategy
  • Team strengthened by new hires in all functions, with significant expansion in R&D and Digital
    • Professor Guy Goodwin appointed Chief Medical Officer, bringing deep experience and leadership in psychiatry; Professor Goodwin is Emeritus Professor of Psychiatry at The University of Oxford
    • Danielle Schlosser PhD appointed Senior Vice-President, Clinical Innovation, to lead therapist research and training, bringing her clinical experience in behavioural health and expertise in digital health innovation. Dr Schlosser joins from Verily Life Sciences, a sister company to Google
    • Leadership hires in clinical science, regulatory affairs, clinical safety, quality and manufacturing, in preparation for phase III, new compounds and additional indications
  • Eight patents now granted covering COMPASS’s novel crystalline polymorphic psilocybin, psilocybin formulations, methods of manufacturing psilocybin, and use of psilocybin for the treatment of psychiatric and neurological indications
    • Numerous additional patent applications under review including three Patent Cooperation Treaty (PCT) applications
  • New podcast launched: “Everyone has a story: talking about mental health”
    • Aims to encourage dialogue around mental health challenges, in order to eliminate stigma and secure better care for those who are suffering

Financial highlights

  • Net loss for the three months ended 30 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)
  • Net loss for the six months ended 30 June 2021 was $30.2 million, or $0.79 loss per share, (after including non-cash share-based compensation expense of $3.6 million) compared with $24.8 million, or $2.61 loss per share, during the same period in 2020 (after including non-cash share-based compensation expense of $11.4 million)
  • Research and development (R&D) expenses were $11.4 million for the three months ended 30 June 2021, compared with $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
  • R&D expenses were $18.2 million for the six months ended 30 June 2021, compared with $12.0 million during the same period in 2020. Of this increase, $5.3 million reflected increased development activities and $2.2 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 $1.8 million in non-cash share-based compensation expense compared with the same period in the prior year
  • General and administrative (G&A) expenses were $8.2 million for the three months ended 30 June 2021, compared with $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
  • G&A expenses were $14.9 million for the six months ended 30 June 2021, compared with $14.4 million during the same period in 2020. The increase was attributable to an increase of $3.3 million and $3.1 million respectively in personnel expenses and facilities and other expenses, offset against a decrease of $6.1 million in non-cash share-based compensation expenses
  • Cash and cash equivalents were $316.3 million as of 30 June 2021, compared with $190.3 million as at 31 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

Conference call

The COMPASS Pathways management team will host a conference call at 1.00pm UK (8.00am ET) on 11 August 2021. The call can be accessed by dialing (833) 665-0659 from the United States, +1 (914) 987-7313 internationally, and 0800 028 8438 from the UK, followed by the conference ID: 3495828.

The call will also be webcast on the investors section of the COMPASS Pathways website (ir.compasspathways.com) and 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 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. Forward-looking statements include express or implied statements relating to, among other things, COMPASS’s business strategy and goals, COMPASS’s expectations regarding its ongoing preclinical work and clinical trials, including the timing of the release of clinical data, COMPASS’s plans to expand the potential indications it may address and to develop new potential compounds or technologies, and COMPASS’s ability to hire, retain and develop personnel. 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 annual report on Form 20-F filed with the US Securities and Exchange Commission (SEC) on 9 March 2021 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, +1 401-290-732

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Guy Goodwin joins COMPASS Pathways as Chief Medical Officer

COMPASS announces changes to its Executive Team

COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, announced that it has appointed eminent psychiatrist, Professor Guy Goodwin FMedSci, as Chief Medical Officer.

Guy Goodwin is Emeritus Professor of Psychiatry at The University of Oxford. He was formerly WA Handley Chair of Psychiatry and Head of the University’s Department of Psychiatry. His research interests have long been in the treatment of mood disorder and the application of neuroscience and technology in understanding its neurobiology, with a focus on developing new treatments.

Professor Goodwin is a Fellow of the American College of Neuropsychopharmacology, and former President of the British Association for Psychopharmacology and of the European College of Neuropsychopharmacology. He is also an Emeritus Senior Investigator on the faculty of the UK National Institute for Health Research, and a Thomson Reuters highly cited researcher (top 1% in field). He is currently Medical Director at P1vital, a clinical research and healthcare organisation.

Professor Goodwin said: “I have been working with COMPASS in an advisory capacity since the beginning of the phase IIb clinical trial of psilocybin therapy for treatment-resistant depression. I am now delighted to be taking a more active role in bringing this innovative therapy to patients who desperately need new options in psychiatry.”

COMPASS also announced that Piers Morgan, Chief Financial Officer, will be leaving towards the end of 2021, to take up a new position in CellCentric, a clinical stage oncology company.

George Goldsmith, CEO and Co-founder, COMPASS Pathways, said: “Guy Goodwin is a deeply experienced psychiatrist, an outstanding leader in the field who is wholly committed to patient care. We are so pleased to welcome him to the team and look forward to working together to transform mental health care for patients.”

George added: “Piers Morgan has been a tremendous CFO for COMPASS. He led our successful IPO last year and follow-on raise earlier this year, and helped us to build a strong finance function as we transitioned to life as a public company. We will miss him enormously and wish him well as he moves on to help another company, towards the end of the year. A new CFO will be appointed and announced in due course.”

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. Forward-looking statements include express or implied statements relating to, among other things, the efficacy of COMP360 psilocybin therapy as a treatment for depression, the expected timing for reporting data related to COMP360, COMPASS’s business strategy and goals, COMPASS’s ability to continue to advance its research, including COMP360, and COMPASS’s expectations regarding the benefits of its psilocybin therapy, including COMP360. 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 research 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 annual report on Form 20-F filed with the US Securities and Exchange Commission (SEC) on 9 March 2021 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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Danielle Schlosser joins COMPASS Pathways from Verily Life Sciences to lead clinical innovation and therapist training

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COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, announced that it has appointed Danielle Schlosser PhD as Senior Vice-President, Clinical Innovation. Dr Schlosser will lead COMPASS’s Therapy Research and Training team, bringing her clinical experience in behavioural health and experience in digital health innovation.

Danielle Schlosser joins COMPASS from Verily Life Sciences, a sister company to Google, where she was Behavioural Health Lead, overseeing the launch of several products including digital measurement capabilities and clinical care initiatives. Danielle is a member of the World Economic Forum’s Global Future Council on Mental Health, and Chair of OneFifteen Health, a non-profit recovery ecosystem helping people who struggle with addiction and mental health disorders. She is also an Assistant Professor of Psychiatry at the University of California San Francisco.

Dr Schlosser said: “I am passionate about improving the mental health and wellbeing of people, at scale, and am inspired by COMPASS’s work and rapid progress in this area. I look forward to working with the team to bring therapies to patients who desperately need better options.”

Ekaterina Malievskaia MD, Chief Innovation Officer and Co-founder, COMPASS Pathways, said: “I am delighted to welcome Danielle to the team. Her clinical and digital innovation expertise will accelerate our work as we move towards a phase III clinical trial, and adds to the tremendous strength we now have in our digital and AI team. COMPASS continues to grow rapidly – we are now a team of 100 people, having expanded in a number of areas, including R&D, manufacturing, quality, and digital. This will enable us to work even more quickly, progressing our psilocybin therapy for treatment-resistant depression, expanding our portfolio into other areas of unmet need, and transforming mental health care. We all remain as committed as ever to bringing innovation to patients who aren’t helped by existing treatments.”

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. Forward-looking statements include express or implied statements relating to, among other things, the efficacy of COMP360 psilocybin therapy as a treatment for depression, the expected timing for reporting data related to COMP360, COMPASS’s business strategy and goals, COMPASS’s ability to continue to advance its research, including COMP360, and COMPASS’s expectations regarding the benefits of its psilocybin therapy, including COMP360. 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 research 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 annual report on Form 20-F filed with the US Securities and Exchange Commission (SEC) on 9 March 2021 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 joins forces with King’s College London and South London and Maudsley NHS Foundation Trust to accelerate psychedelic research and develop new models of mental health care in the UK

COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, has signed a Memorandum of Understanding (MoU) with South London and Maudsley NHS Foundation Trust (SLaM) and the Institute of Psychiatry, Psychology and Neuroscience (IoPPN) at King’s College London, aimed at advancing psychedelic research and developing ambitious new models of care for mental health in the UK.

The three parties are keen to collaborate on a multi-year partnership that reflects their commitment to delivering innovation in mental health care. This collaboration is intended to include research into COMP360 psilocybin therapy and other novel therapies that may be developed by COMPASS in areas of unmet need such as depression, post-traumatic stress disorder (PTSD) and anorexia nervosa. It is also intended to include training therapists in psychedelic therapy, generating real-world evidence, prototyping digital solutions, and building state-of-the-art facilities for research as well as for modelling the “mental health care clinic of the future”.

David Bradley, Chief Executive of South London and Maudsley NHS Foundation Trust, said, “We believe this collaboration could accelerate much-needed research that will translate into evidence-based and direct patient care for people who use our services. This is a really exciting prospect and has the potential to change people’s lives for the better.”

Professor Allan Young, Head of Academic Psychiatry at King’s IoPPN, said, “We have been in partnership with SLaM at the Maudsley Biomedical Research Centre since 2007, and with COMPASS on COMP360 psilocybin therapy research since 2018. By combining our strengths in biomedical research, clinical trials, clinical care, translational science, training, and digital innovation, we can create a world-class centre of excellence in mental health.”

George Goldsmith, CEO and Co‑founder, COMPASS Pathways, said: “So many of us know people who are suffering with mental health issues, but are not helped by existing treatments. We are dedicated to providing new ways of caring for people on their journey to mental wellbeing – but we cannot do this alone. This partnership would help to amplify our combined efforts so we can bring evidence-based innovation, on a large scale, to people in the UK.”

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 completing 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. Forward-looking statements include express or implied statements relating to, among other things, the efficacy of COMP360 psilocybin therapy as a treatment for depression, COMPASS’s business strategy and goals, including the success of its strategy to develop additional therapies for the treatment of depression as well as other mental health illnesses, COMPASS’s ability to continue to advance its research, including with respect to COMP360 and other potential therapies, and COMPASS’s expectations regarding the benefits of its psilocybin therapy, including COMP360, and other therapies it may develop. 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 research 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 annual report on Form 20-F filed with the US Securities and Exchange Commission (SEC) on 9 March 2021 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.

About South London and Maudsley NHS Foundation Trust

South London and Maudsley NHS Foundation Trust is a large and complex multi-site provider of mental health services – providing the widest range of NHS mental health services in the UK. We aim to make a difference to lives by seeking excellence in all areas of mental health and wellbeing. We also provide substance misuse services for people who are addicted to drugs and alcohol. Our 5,000 staff serve a local population of 1.3 million people. We offer more than 260 services including inpatient wards, outpatient and community service. We provide care for 41,000 patients in the community in Lambeth, Southwark, Lewisham and Croydon. As well as serving the communities of south London, we provide more than 20 specialist services for children and adults across the UK including perinatal services, eating disorders, psychosis and autism.

About King’s College London

King’s College London is one of the top 35 UK universities in the world and one of the top 10 in Europe (QS World University Rankings, 2020/21) and among the oldest in England. King’s has more than 31,000 students (including more than 12,800 postgraduates) from some 150 countries worldwide, and some 8,500 staff.

King’s has an outstanding reputation for world-class teaching and cutting-edge research. In the 2014 Research Excellence Framework (REF), eighty-four per cent of research at King’s was deemed ‘world-leading’ or ‘internationally excellent’ (3* and 4*).

Since our foundation, King’s students and staff have dedicated themselves in the service of society. King’s will continue to focus on world-leading education, research and service, and will have an increasingly proactive role to play in a more interconnected, complex world. Visit our website to find out more about Vision 2029, King’s strategic vision to take the university to the 200th anniversary of its founding.

World-changing ideas. Life-changing impact: https://www.kcl.ac.uk/news/kings-news

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 launches new podcast “Everyone has a story: talking about mental health”

COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, launched a new podcast today – “Everyone has a story: talking about mental health”.

The podcast will feature influential guests who will talk about their mental health journeys, share their personal stories, and discuss critical issues in mental health care, including compassion and patient access. Everyone has a story: talking about mental health aims to open up dialogue about mental health challenges, to reduce stigma and to secure better care for those who are suffering.

The first episode will feature mental health campaigner and former UK government health minister, Sir Norman Lamb, who is currently Chair of South London and Maudsley NHS Foundation Trust and Chairman of the Children’s and Young People’s Mental Health Coalition in the UK. He joins COMPASS Pathways CEO and Co-founder George Goldsmith to talk about the experiences of dealing with mental health difficulties in their own families, the impact of COVID-19, and the challenges facing mental health care systems today.

Sir Norman Lamb said: “It’s really important to open up about mental health. Our family has been touched by mental ill health just like most families. Talking about our experiences makes it a little easier for others to seek help when they are worried about what’s going on in their head. I hope the podcast will contribute to this public discussion. We have made real progress over the last 10 years in reducing stigma relating to mental ill health but we still have a long way to go to complete the revolution!”

Episode two, to be released in July, will feature Grammy-award nominated singer, New York Times bestselling author and mental health advocate, Jewel, who will be talking about how she overcame her mental health challenges as a teenager, how she maintains her mental wellbeing today, and her Inspiring Children’s Foundation.

Jewel said: “As kids, we’re not taught mental hygiene and emotional hygiene in the same way that we’re taught, say, dental hygiene. And yet our teeth are nowhere near as important as learning how to curate our thoughts. We need to teach a new emotional language, one that will help children and young people to take charge of their own happiness. That starts by having the conversations and talking openly about mental health, as we’re doing through this podcast.”

George Goldsmith said: “We are living through a growing mental health care crisis. Even before COVID, one in four people experienced some form of mental health challenge, with more than 320 million people around the world suffering with depression. One person dies from suicide every 40 seconds, and in that time 20 more people attempt it. Mental health care remains woefully inadequate for the vast majority of sufferers and stigma is still a huge issue.

“Our vision at COMPASS is a world of mental wellbeing, a world in which there is no stigma around mental health, and people have choices in how they manage their mental health care. We hope the stories that unfold on “Everyone has a story” will inspire listeners to share their own experiences, and open up conversations everywhere about mental health and mental health care.”

Subscribe to “Everyone has a story: talking about mental health” on the COMPASS website or by searching for it on your favourite podcast app.

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 the Company communicates with its investors and the public using its website (www.compasspathways.com), its 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 posted on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in the Company 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 the Company’s website or these channels, or any other website that may be accessed from the 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. Forward-looking statements include express or implied statements relating to, among other things, the safety profile of COMP360 and the efficacy of COMP360 psilocybin therapy as a treatment for depression, COMPASS’s business strategy and goals, COMPASS’s ability to continue to advance its research, including COMP360, and COMPASS’s expectations regarding the benefits of its COMP360 psilocybin therapy. 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 research 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 annual report on Form 20-F filed with the US Securities and Exchange Commission (SEC) on 9 March 2021 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

Posted on

COMPASS Pathways completes COMP360 psilocybin therapy administration for 216 patients in large-scale phase IIb psilocybin therapy trial for treatment-resistant depression

COMPASS on track to report data in late 2021

COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that it has completed psilocybin administration to the target 216 patients in its phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression. This is the world’s largest psilocybin therapy trial to date.

The trial is a randomised controlled, double-blinded, dose-ranging study, investigating the safety and efficacy of psilocybin therapy and comparing a 25mg and 10mg dose of COMP360 psilocybin with a 1mg dose, administered in conjunction with psychological support from specially trained therapists. The 216th patient in the trial had their psilocybin session late last week. Although the target of 216 patients has been achieved and enrolment has now been closed, all enrolled patients who are in the run-in period and have not yet had their psilocybin therapy session, will remain in the trial. This means the number of patients included in the final analysis will be approximately 230, with all psilocybin sessions expected to be completed by 8 July.

Patients are followed-up for 12 weeks after their psilocybin session. COMPASS remains on track to report data in late 2021.

Sue Stansfield PhD, Senior Vice-President, Clinical Operations, COMPASS Pathways, said, “Thank you to everyone on the team and to all our partners and trial sites who have kept this trial going over the last year, despite the pandemic. The safety of patients and of our teams has always been our first priority, and we have introduced measures such as air filtration units and therapists wearing clear masks, to ensure patients were as comfortable as possible in the midst of all the COVID precautions.”

George Goldsmith, CEO and Co-founder, COMPASS Pathways, said, “Completing recruitment to our trial is a tremendous milestone and a huge step forward towards our goal of getting psilocybin therapy to patients in need. We are fortunate to be doing this in collaboration with hundreds of talented and dedicated people from our 22 trial sites in 10 countries – including investigators, raters, study coordinators and nurses, therapists, and pharmacists – as well as our supply chain and clinical research partners. This has been an amazing effort by the whole team, who are delivering the world’s largest psilocybin therapy clinical trial, in the middle of a pandemic, and with all the uncertainties and changes brought on by national lockdowns and site closures.

“We’d like to recognise and thank everyone who helped to make this trial happen, including all the patients who participated. We are now looking forward to completing the trial, and analysing and sharing the data later in the year. COMPASS is well financed following our recent fundraising of over $165m. We expect to be ready to commence phase III trials as soon as we receive regulatory support to do so, based on our phase IIb results.”

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. Forward-looking statements include express or implied statements relating to, among other things, the efficacy of COMP360 psilocybin therapy as a treatment for depression, the expected timing for reporting data related to COMP360, COMPASS’s business strategy and goals, COMPASS’s ability to continue to advance its research, including COMP360, and COMPASS’s expectations regarding the benefits of its psilocybin therapy, including COMP360. 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 research 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 annual report on Form 20-F filed with the US Securities and Exchange Commission (SEC) on 9 March 2021 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

Posted on

COMPASS Pathways becomes Founding Supporter of the British Neuroscience Association’s inaugural Scholars programme

Programme aims to support students from under-represented ethnic groups

COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, has become a Founding Supporter of the British Neuroscience Association’s (BNA) inaugural Scholars programme, which aims to support students from under-represented ethnic groups to thrive in neuroscience, and build a supportive community through networking opportunities, bursaries and mentorship.

COMPASS’s involvement is part of its ongoing commitment to fostering, cultivating and preserving a bold culture of equity, diversity and inclusion (EDI) within the company and in the wider neuroscience and health care communities.

George Goldsmith, CEO and Co-founder of COMPASS Pathways, said: “COMPASS Pathways is proud to be a Founding Supporter of the BNA’s Scholars programme. We are fully committed to equitable access in all areas of our research and our work, and we are excited about driving this agenda forward with the BNA and other founding partners, in support of neuroscience students.”

COMPASS is one of eight Founding Supporters, alongside Bristol Neuroscience (University of Bristol), DeepMind, Gatsby Foundation, Guarantors of Brain, International Brain Research Organization (IBRO), MSD and the UK Dementia Research Institute.

BNA President, Rik Henson, said: “Our Founding Supporters represent the breadth of the neuroscience sector, covering academic, commercial, and third sector organisations, all united in the goal of improving EDI in neuroscience. We are delighted to welcome COMPASS Pathways to the programme, given its leadership in mental health care, as well as our close alignment to its values and its approach to EDI.”

The cohort of seven students accepted onto the BNA Scholars programme was announced in March 2021. Each student will be matched with a mentor and remain on the programme for three years.

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 the Company communicates with its investors and the public using its website (www.compasspathways.com), its 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 posted on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in the Company 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 the Company’s website or these channels, or any other website that may be accessed from the 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. Forward-looking statements include express or implied statements relating to, among other things, the safety profile of COMP360 and the efficacy of COMP360 psilocybin therapy as a treatment for depression, COMPASS’s business strategy and goals, COMPASS’s ability to continue to advance its research, including COMP360, and COMPASS’s expectations regarding the benefits of its COMP360 psilocybin therapy. 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 research 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 annual report on Form 20-F filed with the US Securities and Exchange Commission (SEC) on 9 March 2021 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

Posted on

COMPASS Pathways plc to participate in JMP Securities and H.C. Wainwright 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 in June.

George Goldsmith, Chairman, CEO and Co-founder, and Lars Wilde, President, Chief Business Officer, and Co-founder, will be participating in a fireside chat at the JMP Securities Life Sciences Conference at 10:30 am ET on 16 June.

George Goldsmith and Lars Wilde will be presenting a corporate update at the H.C. Wainwright Psychedelics in Psychiatry and Beyond Virtual Conference, which will be available for streaming at 9 am ET on 17 June. Lars Wilde will also be participating in H.C. Wainwright’s “Patient Experience and Commercial Considerations When Launching Psychoactive Agents in Psychiatry” panel discussion at 2 pm ET.

Members of the management team will be holding investor meetings at both conferences.

Live audio webcasts of the talks will be available on the “Events” page of the Investors section of the COMPASS website. A replay of the webcast will be available for 30 days following the event. For more information, please visit ir.compasspathways.com.

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, USA. 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

Posted on

COMPASS Pathways and Kings College London publish cognition results from COMP360 psilocybin study in healthy volunteers

COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, has reported further results from a phase I study showing that its COMP360 psilocybin had no clinically-relevant negative effect on cognitive function, when administered to healthy adult volunteers with support from specially trained therapists.

The data (see poster) from the randomised, double-blind, placebo-controlled, phase I trial conducted at King’s College London, will be presented today at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, by Dr James Rucker, Consultant Psychiatrist and Senior Clinical Lecturer in Psychopharmacology at King’s College London’s Institute of Psychiatry, Psychology and Neuroscience (IoPPN). Initial results from the study were published in December 2019. The results published today present a more in-depth analysis of cognitive data and showed some trends of positive effects, but these were minor and call for further exploration in clinical populations.

The study looked at the effects of two doses of COMP360 psilocybin (10mg and 25mg) compared with placebo in 89 healthy male and female adult volunteers. The participants were randomised in a 1:1:1 ratio to receive 10mg COMP360 (n=30), 25mg COMP360 (n=30), or placebo (n=29). The drug was administered simultaneously to up to six participants, who all received 1:1 psychological support from trained therapists throughout the session.

Aspects of cognitive function were measured using the gold standard Cambridge Neuropsychological Test Automated Battery (CANTAB), one day prior to COMP360 administration (baseline), and one week and four weeks after administration.

Key results:
• These findings suggest that single doses of COMP360 do not exert clinically-relevant, negative effects in healthy volunteers on the cognitive functions assessed
• On some of the CANTAB measures, there were trends demonstrating, on average, better cognitive performance in the COMP360 groups by week four, compared with baseline. These findings call for further investigation in clinical populations
• The small sample size, and the fact that participants were typically highly educated, limit the generalisability of results
• As reported previously, there were no serious adverse events, and COMP360 psilocybin was found to be generally safe and well-tolerated

Dr Ekaterina Malievskaia, Chief Innovation Officer and Co-founder, COMPASS Pathways, said: “This study is an important part of our clinical development programme of psilocybin therapy for treatment-resistant depression (TRD). The results are encouraging and we are looking forward to reporting data from our phase IIb trial of COMP360 psilocybin therapy for treatment-resistant depression (TRD) later this year.”

Dr Rucker said: “This study, the largest randomised placebo-controlled trial of psilocybin to date, found that COMP360 psilocybin had no clinically-relevant negative effect on cognitive function. The results of the study are clinically reassuring and support further development of psilocybin therapy for patients with mental health conditions that have not improved with existing treatments, such as TRD.”

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

About King’s College London

King’s College London is one of the top 10 UK universities in the world (QS World University Rankings, 2018/19) and among the oldest in England. King’s has more than 31,000 students (including more than 12,800 postgraduates) from some 150 countries worldwide, and some 8,500 staff.
The Institute of Psychiatry, Psychology & Neuroscience (IoPPN) which is the premier centre for mental health and related neurosciences research in Europe. It produces more highly cited outputs (top 1% citations) on mental health than any other centre (SciVal 2019) and on this metric we have risen from 16th (2014) to 4th (2019) in the world for highly cited neuroscience outputs. World-leading research from the IoPPN has made, and continues to make, an impact on how we understand, prevent and treat mental illness and other conditions that affect the brain. https://www.kcl.ac.uk/ioppn @KingsIoPPN

Availability of other information about COMPASS Pathways

Investors and others should note that the Company communicates with its investors and the public using its website (www.compasspathways.com), its 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 posted on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in the Company 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 the Company’s website or these channels, or any other website that may be accessed from the 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. Forward-looking statements include express or implied statements relating to, among other things, the safety profile of COMP360 and the efficacy of COMP360 psilocybin therapy as a treatment for depression, COMPASS’s business strategy and goals, COMPASS’s ability to continue to advance its research, including COMP360, and COMPASS’s expectations regarding the benefits of its COMP360 psilocybin therapy. 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 research 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 annual report on Form 20-F filed with the US Securities and Exchange Commission (SEC) on 9 March 2021 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

Posted on

COMPASS Pathways plc announces financial results and business highlights for the first quarter 2021

  • New England Journal of Medicine publishes exploratory study showing signals of positive activity in COMP360 psilocybin compared with escitalopram for major depressive disorder
  • Two further US patents granted
  • Equity financing raises gross proceeds of $144 million
  • Phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression (TRD) on track to report data by end of 2021
  • Wayne J Riley MD joins Board of Directors and Anne Benedict is appointed Chief People Officer
  • Conference call today at 1:00pm UK (8:00am ET)

COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported its financial results for the first quarter 2021 and gave an update on recent progress across its business.

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.”

Business highlights

  • Phase IIb clinical trial of COMP360 psilocybin therapy for TRD continues to progress
    • On track to report top-line data by end of 2021
  • COMP360 data published in the New England Journal of Medicine
    • Signal-generating, exploratory research from independent study at Imperial College London (n=59) comparing the efficacy and mechanisms of action of psilocybin with a six-week course of escitalopram, a selective serotonin reuptake inhibitor (SSRI), for major depressive disorder (MDD)
    • Study showed signals of positive activity in COMP360 psilocybin when compared with escitalopram and concludes that psilocybin findings should be explored further in larger studies
    • COMP360 psilocybin was generally well-tolerated and there were no Serious Adverse Events
  • Two new patents granted by the US Patent and Trademark Office
    • 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 recognised with six granted patents, including three in the US, two in the UK, and one in Germany
  • Senior appointments
    • Wayne J Riley MD joins COMPASS’s Board of Directors. Wayne is President of the State University of New York Downstate Health Sciences University, Brooklyn, where he holds tenured professorships in internal medicine and health policy and management. He has a breadth of experience in clinical and academic medicine, research programme oversight, biotechnology, primary care, public health, healthcare management and policy, healthcare quality, academic health science centre administration, and government service
    • Anne Benedict is appointed COMPASS’s first Chief People Officer. Anne has more than 25 years of global experience in human resources, talent and organisational development, and will help COMPASS attract, retain and develop the talent and people we need to achieve our mission
  • Equity financing priced, raising gross proceeds of $144 million

Financial highlights

  • Net loss for the three months ended March 31, 2021, was $12.7 million, or $0.35 loss per share (after including non-cash share-based compensation expense of $1.7 million), compared with $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 for the three months ended March 31, 2021, compared with $5.2 million during the same period in 2020. Of this increase, $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
  • General and administrative (G&A) expenses were $6.7 million for the three months ended March 31, 2021, compared with $3.5 million during the same period in 2020. Of the increase, $1.4 million was related to increased personnel costs, $1.1 million related to additional facility and other administrative expenses, and $0.6 million related to increased legal and professional expenses
  • Pro-forma cash and cash equivalents was $179.5 million as of March 31, 2021, compared with $190.3 million at 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 (“ADSs”) at a price of $36.00 per ADS for total gross proceeds of $144 million.

Conference call

COMPASS Pathways’ management team will host a conference call at 1.00pm UK (8.00am ET) on 13 May 2021. 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: 4498819.

The call will also be webcast on the investors section of the COMPASS Pathways website (ir.compasspathways.com) and 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 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. Forward-looking statements include express or implied statements relating to, among other things, COMPASS’s business strategy and goals, COMPASS’s expectations regarding its ongoing preclinical work and clinical trials, including the timing of the release of clinical data, COMPASS’s plans to expand the potential indications it may address and to develop new potential compounds or technologies, and COMPASS’s ability to hire, retain and develop personnel. 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 annual report on Form 20-F filed with the US Securities and Exchange Commission (SEC) on 9 March 2021 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