CMPS COMPASS Pathways Plc
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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Psilocybin
Treatment Resistant Depression
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Phase 2b
Phase 2b
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Investigator-initiated study shows remission in major depression symptoms for 50% of participants
London, UK – 20 October 2021
COMPASS Pathways plc (NASDAQ:CMPS) ("COMPASS"), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, welcomed the topline data shared today from an open-label study of psilocybin therapy for depression in cancer patients. Within one week of a single administration of COMP360 psilocybin therapy, 50% of participants achieved remission in depression symptoms, which was sustained for the eight week follow-up period.This investigator-initiated feasibility study was conducted by Maryland Oncology Hematology at the Aquilino Cancer Center in Rockville, Maryland, USA. It was an open-label study involving 30 patients with cancer diagnosis and major depressive disorder (MDD), all of whom completed the study. Half of the participants had previously been treated for their current episode of depression with antidepressants and all were receiving active treatment for cancer; 19 participants had no previous experience with psychedelic substances. Patients were given a 25mg dose of COMP360 psilocybin in conjunction with psychological support from specially trained therapists, following the COMP360 psilocybin therapy protocol. Unlike earlier psilocybin therapy trials for depression in cancer, this study was not restricted to patients with late-stage cancer. The Maryland team also pioneered simultaneous group administration in a cancer care centre, with two to four patients being given psilocybin at the same time, with 1:1 therapist support. This tested the value of group support for cancer patients as well as the potential for increased scalability in providing psilocybin therapy in real world settings.
COMP360 psilocybin therapy was found to be generally well tolerated with no treatment-related serious adverse events. Adverse effects seen on the day of dosing were as expected from experience in healthy volunteer groups and included headache, changes in sensory perception and mood alteration.
Patients were assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), a clinician-administered symptom questionnaire. A sustained response rate (a decrease of ≥50% in the MADRS score from baseline observed at any visit up to and including week 3, and also fulfilled at week 8) was seen by 24 patients; 15 patients showed remission of depression symptoms (a MADRS score <10) one week after a single dose of psilocybin, which was sustained up to eight weeks. The 30 patients in the study began with an average MADRS score of 25.9, representing moderate depression. After psilocybin therapy, the average score dropped by 19.1 points. The study investigators noted that this was an open-label study in which neither patients nor raters were blinded, so there is a significant risk that the results incorporate a large expectancy bias.
Dr Manish Agrawal, medical oncologist, Co-director of Clinical Research at the Aquilino Cancer Center, and the trial's Principal Investigator, said: "A cancer diagnosis can change the course of a patient's life. For complete cancer care, we need to focus on whole-person healing and include the mental wellbeing of our patients. This is not widely addressed today, but it's time to do something about it. These study results have shown that psilocybin therapy may be helpful with MDD in cancer, and we look forward to doing further analysis and following up with additional studies. While it's premature to draw any definitive conclusions from this study, simultaneous administration appears to be well tolerated and feasible, and the results are promising and worthy of further research."
Professor Guy Goodwin, Chief Medical Officer, COMPASS Pathways, said: "These preliminary findings suggest COMP360 psilocybin therapy was well tolerated by cancer patients with major depressive disorder. It is promising to see that this may be a feasible fast-acting therapy for depressed patients with a significant physical co-morbidity. This would certainly be welcome in conditions where depression is difficult to treat in a timely way."
Professor Goodwin added: "This open-label MDD study is very different from the randomised, controlled, double-blinded phase IIb study that COMPASS has conducted for patients with treatment-resistant depression. Nevertheless, it has given a positive signal of the potential for COMP360 psilocybin therapy, and we are delighted to see that a number of patients showed signs of improvement. We are now considering how we take this forward with future studies as we continue to develop a broad portfolio of therapies in areas of significant unmet need in mental health care."
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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 PathwaysInvestors 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 statementsThis 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, the benefits of additional patent protection to help achieve these goals, COMPASS's expectations regarding the benefits of its psilocybin therapy; and the potential for topline, preliminary open label data from an investigator-initiated study using COMP360 psylocibin therapy to be predictive of results in other trials involving 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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London, UK – 19 October 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 been granted its fourth patent by the US Patent and Trademark Office (USPTO). This is COMPASS's first patent with claims covering its Form A hydrate psilocybin. The Form A hydrate is distinct from the anhydrate psilocybin for which the company has already been granted eight patents in the US, UK, Germany and Hong Kong, and which is used in COMP360, COMPASS's synthesised psilocybin formulation being developed for psilocybin therapy in treatment-resistant depression.The new patent, US Patent No 11,149,044, was granted on 19 October 2021, with composition claims to an alternative crystalline psilocybin, pharmaceutical formulations containing crystalline psilocybin and methods of treating major depressive disorder with the crystalline psilocybin.
George Goldsmith, CEO and Co-founder, COMPASS Pathways, said: "We are focused on developing the best therapies and bringing them to patients who are not helped by existing therapies in mental health care. With each new patent grant, the USPTO is recognising our innovation, enabling us to continue to do the highest quality clinical research and to broaden our portfolio of evidence-based therapies for patients who urgently need better options."
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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 PathwaysInvestors 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 statementsThis 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, the benefits of additional patent protection to help achieve these goals, and COMPASS's expectations regarding the benefits of its 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 7423
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London, UK, Sept. 21, 2021 (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 management will participate in two upcoming investor conferences as follows:
- Maxim Group and M-Vest Mental Health Advances in Mental Health, Psychedelics and Non-Psychedelics Virtual Conference: "Clinics and Commercialization: Scaling psychedelics to meet the needs of the mental health space" and "Depression: Spravato opened the door - what comes next?" panels at 12:00pm and 2:00pm ET on September 22, 2021
- Cantor Virtual Global Healthcare Conference: fireside chat at 10:40am ET on September 30, 2021
Links to these webcasts 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.
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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.
Enquiries
Media: Tracy Cheung, tracy@compasspathways.com, +44 7966 309024
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7423
- Maxim Group and M-Vest Mental Health Advances in Mental Health, Psychedelics and Non-Psychedelics Virtual Conference: "Clinics and Commercialization: Scaling psychedelics to meet the needs of the mental health space" and "Depression: Spravato opened the door - what comes next?" panels at 12:00pm and 2:00pm ET on September 22, 2021
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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 acquired an intellectual property (IP) portfolio including patent applications covering a variety of psychedelic and empathogenic substances. The IP was developed together with inventor Matthias Grill PhD, founder and CEO of MiHKAL GmbH in Basel, Switzerland, who will be working with COMPASS on an exclusive research project to develop new product candidates.
The substances covered in the IP portfolio include a variety of psychedelic and empathogenic compounds, some of which are prodrugs - pharmacologically inactive compounds which are metabolised inside the body to produce an active drug. The new substances include novel derivatives of known compounds, increasing the confidence in therapeutic effects and safety profile while offering optimised characteristics.
Dr Matthias Grill has been involved in psychedelic chemistry research for over 15 years, gaining his PhD at the Max Planck Institute. He has held positions as Head of R&D at Arbolea GmbH, Lipomed AG and THC Pharm GmbH, and has synthesised psychedelic substances for a number of human research studies, including at the University of Basel and the National Institute of Mental Health in the Czech Republic.
Dr Grill said: "Chemistry still happens inside the flask and not on paper. Inspired by the work of chemists like Albert Hofmann and Alexander Shulgin, I am proud to be developing these evolved compounds in Switzerland, where many of the initial psychedelics were first researched and synthesised. We are creating novel candidates to address many of the mental health challenges we face today."
Lars Wilde, Chief Business Officer, President and Co-founder, COMPASS Pathways, said: "We are delighted to be working with Matthias and MiHKAL GmbH. This agreement will strengthen and expand our IP and development portfolio with new compounds. We plan to move some of these compounds into clinical development within the next two years, taking us closer to our goal of helping patients with urgent unmet needs in mental health care."
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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 statementsThis 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 potential efficacy of compounds included in the acquired IP portfolio in treating mental health illnesses, COMPASS's expectation to progress and the expected timing for progressing one or more of the compounds included in the acquired IP portfolio into preclinical study and clinical development, COMPASS's business strategy and goals, COMPASS's ability to continue to advance its research, including COMP360 and any product candidates that are selected from the acquired compounds, 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 7423
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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, has engaged Hamilton Morris, the research scientist and film-maker, as a full-time consultant, who will be working primarily at the COMPASS Discovery Center, based at University of the Sciences in Philadelphia (USciences) in the United States. Mr Morris will be advising COMPASS on research related to new psychedelic compounds that could be developed into therapies in areas of unmet mental health need.Hamilton Morris is the creator and director of the documentary series Hamilton's Pharmacopeia, in which he investigates the chemistry, history, and cultural impact of various psychoactive drugs. He also carries out chemistry research at USciences, alongside the COMPASS Discovery Center team there, led by Dr Jason Wallach, Assistant Professor of Pharmaceutical Sciences at USciences.
Mr Morris said: "For over a decade, Jason and I have worked together studying the chemistry and pharmacology of psychedelics. Working with the COMPASS team will allow us to make strides in developing novel psychedelics that could have tremendous medical and scientific value."
Lars Wilde, Chief Business Officer, President and Co-founder, COMPASS Pathways, said, "I am delighted to welcome Hamilton to our team. He is already well known for his deep knowledge and his enthusiasm. I believe his expertise will further enhance our world-class team of scientists who are finding new compounds for our portfolio of therapies for patients who are suffering with serious mental health challenges."
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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, 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 7423