COMPASS Pathways plc to announce fourth quarter and full year 2021 financial results on 24 February 2022

COMPASS Pathways plc to announce fourth quarter and full year 2021 financial results on 24 February 2022

LONDON, United Kingdom, Feb. 17, 2022 (GLOBE NEWSWIRE) — 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 fourth quarter and full year 2021, and provide an update on recent business developments on 24 February 2022.

The management team will host a conference call at 8:00am ET (1:00pm UK) on 24 February. The call can be accessed by dialing (833) 665-0659 from the United States, (914) 987-7313 internationally, and 0800 028 8438 from the UK, followed by the conference ID: 2825279.

The call will also be webcast 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 have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. This was the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever conducted, and our topline data showed a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also running a phase II clinical trial of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD). COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the 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.        

Enquiries

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

Two thirds of physicians surveyed believe psilocybin therapy has potential benefit for patients with treatment-resistant depression

Two thirds of physicians surveyed believe psilocybin therapy has potential benefit for patients with treatment-resistant depression

COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, and Sermo, a global leader in physician insights, today announced findings from a survey of Sermo physician members that showed two thirds (66%) of doctors surveyed believe psilocybin therapy has potential therapeutic benefit for patients with treatment-resistant depression (TRD).

More than 320 million people globally suffer with major depressive disorder (MDD)[i], the leading cause of disability worldwide and one of the fastest growing mental health illnesses[ii]. About a third of these patients – 100 million people – aren’t helped by existing therapies and suffer with TRD[iii].

Psilocybin therapy is an approach being investigated for the treatment of mental health challenges, including TRD. It combines the pharmacological effects of a synthesised version of psilocybin, a psychoactive substance that is an active ingredient in some species of mushrooms, with psychological support[iv].

The survey of 259 Sermo member physicians, sponsored by COMPASS, was conducted in November 2021 and completed by participants from the US, the UK, France, Italy, Denmark, Spain and the Netherlands. Doctors were asked their views on the future of psychiatric therapy and the potential role of psilocybin therapy.

Key survey findings:

  • 66% of doctors surveyed believe psilocybin therapy has potential benefit for patients with TRD
  • 50% would prescribe psilocybin therapy, if it was approved; 32% are undecided
  • The greatest potential advantages to psilocybin treatment are believed to be: improved efficacy in treatment-resistant conditions (30%), rapid onset of action (26%), and different mechanism of action from existing therapies (19%)
  • The greatest potential barriers to treatment were cited as: needing a dedicated space for six to eight hours (28%), lack of trained therapists in a new model of psychological support (21%), and office infrastructure (15%)
  • Opinions on the optimal setting for psilocybin administration varied by region: 50% of European respondents said hospital; 42% of US respondents said specialised network of centres
  • Physicians also noted the need to educate healthcare professionals on the potential benefits of psilocybin therapy and on how to incorporate the therapy into their practice, if approved

“Severe mental illnesses, such as treatment-resistant depression, have affected too many people in society for too long. Physicians are looking for new approaches to accelerate the healing process, particularly for patients for whom current therapies have failed,” said Murali Doraiswamy MBBS, FRCP, Professor of Psychiatry and Behavioural Sciences at Duke University School of Medicine, and an advisor to Sermo.

Dr Guy Goodwin, Chief Medical Officer, COMPASS Pathways, said: “These findings underline the fact that physicians need more options in helping patients suffering with treatment-resistant depression. COMPASS is developing COMP360 psilocybin therapy through a rigorous programme of research in the hope that we can offer just such an option. It’s very encouraging to see that so many doctors see the potential that psilocybin could have and these insights will help us to understand how to introduce COMP360 psilocybin, with psychological support, into medical systems, if approved.”

-Ends-

Survey methodology   

The survey was designed to assess attitudes towards the use of psilocybin therapy in general, in psychiatry. The survey was conducted online via Sermo’s RealTime platform and the random sample of physicians received compensation for their time and expertise. Survey limitations include sampling bias, inability to deduce causality from opinion polls, confounding variables not measured, and other factors.

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 have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. This was the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever conducted, and our topline data showed a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also running a phase II clinical trial of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD). COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the 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 safety or efficacy of psilocybin therapy, including COMP360, as a treatment for depression, COMPASS’s business strategy and goals, including its ability to launch and commercialise products, COMPASS’s expectations for the timing of its pivotal phase III programme and the potential for that or other trials to support regulatory filings and approvals, COMPASS’s ability to continue to advance its research or develop plans to bring its product candidates to patients, including  COMP360, clinicians’ perceptions of the potential advantages and efficacy of COMP360 in relation to other available therapies, including any new therapies that may be approved for the indications we are investigating, and COMPASS’s expectations regarding the benefits of psilocybin therapy and the effectiveness of its executive team. 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 Sermo

Sermo turns physician experience, expertise, and observations into actionable insights for the global healthcare community. Engaging with more than 1.3 million HCPs across 150 countries, the company provides physicians with a social platform and unique community that fosters impactful peer-to-peer collaboration & discussions about issues that are important to them and their patients. Sermo offers on demand access to physicians via a suite of proprietary technology to provide business intelligence that benefits pharmaceutical, healthcare partners, and the medical community at large. To learn more, visit www.sermo.com.

Enquiries

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

[i] WHO (2017). Depression and Other Common Mental Disorders Global Health Estimates [Online]. Available at: https://apps.who.int/iris/bitstream/handle/10665/254610/WHO-MSD-MER-2017.2-eng.pdf [Accessed 21 October 2021]

[ii] WHO (2012). Depression: A Global Crisis [Online]. Available at: https://www.who.int/mental_health/management/depression/wfmh_paper_depression_wmhd_2012.pdf [Accessed 21 October 2021]

[iii] Al-Harbi KS. Treatment-resistant depression: therapeutic trends, challenges, and future directions. Patient Preference and Adherence. 2012; 6: 369–388

[iv] Ross et al, 2016; Griffiths et al, 2016; Carhart-Harris et al, 2016

COMPASS selected for addition to NASDAQ Biotechnology Index

COMPASS selected for addition to NASDAQ Biotechnology Index

COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced it has been selected for addition to the Nasdaq Biotechnology Index (Nasdaq: NBI), effective from market open on 20 December 2021. The NBI is designed to track the performance of a set of securities listed on The Nasdaq Stock Market (Nasdaq) that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark. For this year’s annual reconstitution, 120 securities will be added to the Index and 16 will be removed.

George Goldsmith, CEO and Co-founder of COMPASS Pathways, said, “Our inclusion in the index will enable us to potentially reach new audiences as we continue to deliver our clinical development programme of COMP360 psilocybin therapy with the goal of helping patients suffering with the most challenging issues in mental health.”

The NBI is widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Exchange traded funds (ETFs) that track the NBI include the ProShares Ultra NASDAQ Biotechnology ETF (BIB), ProShares UltraShort NASDAQ Biotechnology ETF (BIS), Invesco NASDAQ Biotech UCITS ETF (SBIO), and iShares Nasdaq Biotechnology Index Fund (IBB), among others.

For more information about the NASDAQ Biotechnology Index visit Overview for NBI (nasdaqomx.com).

-Ends-

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 have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. This was the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever conducted, and our topline data showed a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also running a phase II clinical trial of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD). COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the 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 safety or efficacy of COMP360 psilocybin therapy as a treatment for depression, COMPASS’s expectations for the timing of its pivotal phase III programme and the potential for that or other trials to support regulatory filings and approvals, COMPASS’s business strategy and goals, the future accessibility of COMP360 psilocybin therapy, COMPASS’s ability to continue to advance its research, including COMP360, COMPASS’s expectations regarding the benefits of its psilocybin therapy, including COMP360 and COMPASS’s ability to advance new psychedelic compounds in other areas of unmet mental health need. 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

COMPASS Pathways announces changes in Executive Team

COMPASS Pathways announces changes in Executive Team

Matthew Owens appointed General Counsel and Chief Legal Officer;
Lars Wilde, Chief Business Officer and Co-founder, to move into senior advisory role

 
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 appointed Matthew Owens as General Counsel and Chief Legal Officer. Mr Owens will join COMPASS on 1 February 2022. The company also announced that Lars Wilde, President, Chief Business Officer and Co-founder, will be moving into a senior advisory role with COMPASS from 1 January 2022.

Matthew Owens joins COMPASS from Novartis International, where he is Global Head Legal, Digital, with responsibility for developing and executing legal and IP strategy. He has been with Novartis since 2010, also serving as Senior Legal Counsel, and as Head Legal, Strategic Partnerships and Digital. Named “Most Innovative European In-House Lawyer 2015” by the Financial Times, Mr Owens is highly experienced in leading legal teams in the fields of digital transformation, biotech and innovation. Prior to Novartis, he was Senior Counsel at Solvay Pharmaceuticals, and Corporate Counsel at Mettler-Toledo. He holds a Bachelor of Arts (Pre-Law & Political Science, History & Criminology) from Capital University, Columbus, Ohio, and a JD (Doctor of Law) from Capital University Law School where he was a Presidential Scholar. He is a lecturer  at the University of Zurich Law School’s Europa Institute.

Matthew Owens said: “COMPASS is bringing innovation to mental health care, and I am so excited to be joining them. I am passionate about digital health and improving the patient experience and look forward to working with the COMPASS team as they continue to develop new therapies supported by digital technologies.”

Lars Wilde joined COMPASS in 2017 as a co-founder and has been instrumental to the company’s many achievements in a number of strategic and operational areas, including fundraising, business development, and the development of its Discovery Center.

Lars Wilde said: “We have built an amazing company at COMPASS and I am grateful to everyone who continues to support us. We are the clear leader in developing psilocybin therapy for unmet mental health needs, initially in treatment-resistant depression, and now moving into PTSD and other disease areas. We are building a portfolio of new psychedelic compounds through our Discovery Center and partnerships. We have raised more than $429 million and we have established a strong team of more than 120 talented, passionate and dedicated people. Above all, we have maintained our commitment to patients and to our goal of transforming mental health care. This is a natural time for me to transition to an advisory role and I am proud to be able to continue working with COMPASS.”

George Goldsmith, CEO and Co-founder, COMPASS Pathways, said: “COMPASS has grown rapidly since its inception in 2016. Our mission and commitment to patients remain the same, but operationally we are a very different company and our executive team is changing to reflect this. Earlier this month, we announced the appointment of Mike Falvey as our new CFO, with experience in launching and commercialising innovation for patients. As General Counsel, Matt will bring significant expertise in technology, digital health and innovation. We are delighted to welcome him to our team and excited about working together to transform mental health care.”

George Goldsmith continued: “The three COMPASS co-founders have always worked closely and tirelessly to create a new type of company to transform mental health care. Without Lars, COMPASS would not be where it is today. He has helped transform us from a start-up to a well-funded Nasdaq-listed company with the best team, a strong pipeline, and a real opportunity to make a difference for patients. We will miss him being here every day but look forward to his continued contributions as a senior advisor and his support as a major shareholder. We are excited to see what Lars does next as we are sure it will be a success!”

-Ends-

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 have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. This was the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever conducted, and our topline data showed a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also running a phase II clinical trial of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD). COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the 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 safety or efficacy of COMP360 psilocybin therapy as a treatment for depression, COMPASS’s expectations for the timing of its pivotal phase III programme and the potential for that or other trials to support regulatory filings and approvals, COMPASS’s business strategy and goals, the future accessibility of COMP360 psilocybin therapy, COMPASS’s ability to continue to advance its research, including COMP360, COMPASS’s expectations regarding the benefits of its psilocybin therapy, including COMP360 and COMPASS’s ability to advance new psychedelic compounds in other areas of unmet mental health need. 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

The findings from COMPASS’s depression study keep coming!

COMPASS Pathways announces positive outcome of 25mg COMP360 psilocybin therapy as adjunct to SSRI antidepressants in open-label treatment-resistant depression study

COMPASS Pathways’ (CMPS) announced that patients taking SSRI antidepressants in conjunction with psilocybin therapy had similar outcomes and fewer side effects compared to those who withdrew from SSRIs before the study.

Five patients who withdrew from SSRIs had serious adverse effects, such as suicidal ideation, when given the largest dose. None of the patients on SSRIs had this experience. 

PDF of article

Michael Falvey joins COMPASS Pathways as Chief Financial Officer

Michael Falvey joins COMPASS Pathways as Chief Financial Officer

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 Michael Falvey as Chief Financial Officer, replacing Piers Morgan when he leaves the company, as previously announced, at the end of the year.

Michael Falvey is highly experienced in delivering financial and operational excellence in public and private growth companies. He joins COMPASS most recently from Karyopharm Therapeutics, where he led the financial strategy and prepared the financial infrastructure to support commercial operations as the company delivered pivotal clinical data and prepared to commercialise its first product.  Mr Falvey will assume the title of Chief Financial Officer on 1 January 2022.

Prior to Karyopharm Therapeutics, Mr Falvey served as Chief Financial Officer at several other high-growth companies including Seven Bridges Genomics, Analysis Group, Ahura Scientific, and Aspect Medical Systems, and as Vice-President, Finance, at Millennium Pharmaceuticals Inc. In addition to his healthcare experience, he has held financial positions at Fidelity Investments, Digital Equipment Corporation and General Electric. He holds a Master of Science in Management from the Sloan School of Management at the Massachusetts Institute of Technology and a Bachelor of Science from Georgetown University.

Michael Falvey said: “This is an exciting time to be joining COMPASS Pathways, following the publication of its positive phase IIb topline data earlier this month. They have already achieved so much – raising more than $425 million, completing the world’s largest, randomised, controlled psilocybin therapy clinical trial, creating new approaches in mental health care for treatment-resistant depression and now PTSD – and I look forward to being part of the team and contributing to its success.“

George Goldsmith, CEO and Co-founder, COMPASS Pathways, said: “Mike has an excellent reputation for executing business growth plans and a track record in building strong financial teams. He also has experience of launching and commercialising products which will be invaluable as we bring our COMP360 psilocybin therapy through clinical trials and develop our plans for bringing it to patients. We are so pleased to welcome him to our team and look forward to working together to transform mental health care.”

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 have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. This was the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever conducted, and our topline data showed a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also running a phase II clinical trial of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD). COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the 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 its ability to launch and commercialise products, COMPASS’s ability to continue to advance its research or develop plans to bring its products to patients, 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

More positive findings from biggest psilocybin trial

COMPASS Pathways announces further positive results from groundbreaking phase IIb trial of investigational COMP360 psilocybin therapy for treatment-resistant depression

COMPASS Pathways (CMPS) announced additional findings from the world’s largest psilocybin trial for depression. 

In addition to reduced depression scores, patients showed improvements in anxiety, daily functioning, cognition, and quality of life. Just one day after the treatment, patients had increased positive feelings such as “interested, excited, strong” and decreased negative feelings like “distressed, upset, afraid.” 

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