Newly created role of Chief Patient Officer reinforces Compass' vision of working to achieve broad and equitable access to COMP360, if approved
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Awakn Announces Opening of Four Additional AWKN-001 Phase 3 Trial Sites
Awakn Life Sciences Corp. (CSE: AWKN) (OTCQB: AWKNF) (FSE: 954) ("Awakn" or the "Company"), a clinical-stage biotechnology company developing therapeutics for substance use and mental health disorders, announces the opening of four additional clinical trial sites: University Hospitals Sussex NHS Foundation Trust; South London and Maudsley NHS Foundation Trust; Greater Manchester Mental Health NHS Foundation Trust; and University Hospitals Plymouth NHS Trust. This brings the total active trial sites to 7 in the landmark 'MORE-KARE' Phase 3 trial of AWKN-001 for severe AUD.
AWKN-001 is an investigational, novel medication-assisted treatment for severe AUD, consisting of an N-methyl-D-aspartate receptor-modulating drug (ketamine) delivered intravenously (IV) in combination with manualized psycho-social support for severe AUD.
The MORE-KARE study, or the Multicentre Investigation of Ketamine for Reduction of Alcohol Relapse, is co-funded by a partnership between the UK's Medical Research Council (MRC) and the National Institute for Health and Care Research (NIHR), and Awakn Life Sciences Corp. It is managed by the Exeter Clinical Trials Unit at the University of Exeter.
The Phase 3 trial aims to evaluate the efficacy of a single treatment cycle of AWKN-001. Participants will be randomly allocated into a trial arm, receiving different doses of ketamine infusion along with psycho-social support sessions from a trial therapist. The specific dose and type of psychological support for each participant will be randomly assigned by a computer. Both participants and the research team will be blinded to the assigned dose/support.
Anthony Tennyson, CEO, Awakn, commented: "The expansion of trial sites marks a significant milestone in our mission to address the pressing need for innovative treatments for AUD. We are confident that AWKN-001, has the potential to change the standard of care for individuals suffering from severe alcohol use disorder in the UK, offering them a novel, more effective treatment pathway."
Prof. David Nutt, Chief Research Officer of Awakn, added: "The opening of these additional sites accelerates our ability to gather robust clinical data, essential for bringing this groundbreaking treatment to more patients. With the support of the UK's leading research institutions, we are well-positioned to demonstrate the effectiveness of AWKN-001."
This study is the largest of its kind investigating ketamine-assisted therapy for AUD. The total trial cost is estimated at £2.4 million / CAD 4.2 million, with Awakn contributing £0.8 million / CAD 1.4 million. The trial is being conducted at eight National Health Service (NHS) sites across the UK.
About AWKN-001
AWKN-001 is an investigational, novel medication-assisted treatment for severe AUD, consisting of an N-methyl-D-aspartate receptor-modulating drug (ketamine) delivered intravenously (IV) in combination with manualized psycho-social support in the UK market only.
A phase 2 trial was successfully completed with efficacy proven, achieving 86% abstinence on average over the 6 months post-treatment versus 2% pre-trial and a 50% reduction in Heavy Drinking Days versus placebo.
A phase 3 clinical trial ("MORE KARE") is being run by the University of Exeter. This trial is co-funded by the Efficacy and Mechanism Evaluation (EME) Programme - a partnership between the UK's National Institute for Health Research (NIHR) and the Medical Research Council (MRC) - and Awakn Life Sciences Corp.
About Awakn Life Sciences Corp.
Awakn Life Sciences Corp. is a clinical-stage biotechnology company developing therapeutics targeting substance use and mental health disorders. Awakn has a near-term focus on AUD, a condition affecting approximately 29 million adults in the US and approximately 40 million in the US and key European markets for which the current standard of care is inadequate. Our goal is to provide breakthrough therapeutics to addiction sufferers in desperate need and our strategy is focused on commercialising our R&D pipeline across multiple channels.
www.awaknlifesciences.com | LinkedIn | X (formerly Twitter)
About the University of Exeter
The University of Exeter is the sponsor of this clinical trial with overall trial management, data management and statistical analysis provided in collaboration with the Exeter Clinical Trials Unit (University of Exeter). At the University of Exeter, we combine teaching excellence and high levels of student satisfaction with world class research at our campuses in Exeter and Cornwall. We are a member of the Russell Group of leading research-intensive universities.
About The National Institute for Health and Care Research (NIHR)
The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:
- Funding high quality, timely research that benefits the NHS, public health and social care;
- Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services;
- Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research;
- Attracting, training and supporting the best researchers to tackle complex health and social care challenges;
- Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system;
- Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.
NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through UK Aid from the UK government.
About the Medical Research Council
The UKRI Medical Research Council is at the forefront of scientific discovery to improve human health. Founded in 1913 to tackle tuberculosis, the MRC now invests taxpayers' money in some of the best medical research in the world across every area of health. Thirty-three MRC-funded researchers have won Nobel prizes in a wide range of disciplines, and MRC scientists have been behind such diverse discoveries as vitamins, the structure of DNA and the link between smoking and cancer, as well as achievements such as pioneering the use of randomised controlled trials, the invention of MRI scanning, and the development of a group of antibodies used in the making of some of the most successful drugs ever developed.
Today, MRC-funded scientists tackle some of the greatest health problems facing humanity in the 21st century, from the rising tide of chronic diseases associated with ageing to the threats posed by rapidly mutating micro-organisms. The Medical Research Council is part of UK Research and Innovation.
Notice Regarding Forward-Looking Information
This news release contains certain forward-looking information and forward-looking statements, as defined in applicable securities laws (collectively referred to herein as "forward-looking statements"). Forward-looking statements reflect current expectations or beliefs regarding future events or the Company's future performance. All statements other than statements of historical fact are forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "continues", "forecasts", "projects", "predicts", "intends", "anticipates", "targets" or "believes", or variations of, or the negatives of, such words and phrases or state that certain actions, events or results "may", "could", "would", "should", "might" or "will" be taken, occur or be achieved, including statements relating the business of the Company. All forward-looking statements, including those herein are qualified by this cautionary statement.
Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include, but are not limited to: fluctuations in general macroeconomic conditions; the business plans and strategies of the Company; the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; fluctuations in securities markets; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; expectations regarding the size of the addiction market; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements.
Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking information. For more information on the Company, investors are encouraged to review the Company's public filings on SEDAR at www.sedar.com. The Company disclaims any intention or obligation to update or revise any forward- looking information, whether as a result of new information, future events or otherwise, other than as required by law.
Investor Enquiries:
Anthony Tennyson, CEO, Awakn Life Sciences
anthony.tennyson@awaknlifesciences.com
416-270-9566
Compass Pathways Appoints Steve Levine, M.D., as Chief Patient Officer
Compass Pathways plc (Nasdaq: CMPS) ("Compass"), a biotechnology company dedicated to accelerating access to evidence-based innovation in mental health, today announced the appointment of Steve Levine, M.D., as Chief Patient Officer, effective immediately. In this newly developed executive team role, Dr. Levine will be responsible for ensuring that patient-centric strategies are embedded across the organization and that treatments and initiatives developed by the company are focused on addressing unmet needs in current clinical care and are designed to improve patient outcomes.
"Steve has spent the past four years working to deeply understand barriers to care for patients living with serious mental health conditions and he is committed to helping find solutions to address those barriers," said Kabir Nath, CEO of Compass Pathways. "Steve shares a passion for our mission to bring better options to people who urgently need them, and I am delighted to welcome him onto the executive leadership team and into the newly developed Chief Patient Officer role."
Dr. Levine has been a member of the Compass team since 2020, serving as Senior Vice President of Patient Access. Dr. Levine is a board-certified psychiatrist who has spent his career working across multiple facets of the healthcare system to improve people's lives through creating access to innovation. Dr. Levine completed his internship and residency in psychiatry at New York - Presbyterian Hospital/Weill Cornell Medical Center. He then completed a fellowship subspecialty training in psychosomatic medicine/psycho-oncology at Memorial Sloan Kettering Cancer Center/New York - Presbyterian Hospital. Prior to Compass, he led the company he founded in 2010, Actify Neurotherapies, that built new models of care delivery across the US for interventional psychiatry treatments. He has published extensively in both peer-reviewed journals and popular media, presented to both professional and lay audiences around the world, served in leadership roles for professional societies and not-for-profit entities, and received numerous awards for leadership and service. Dr. Levine is also an adjunct professor at Rutgers Medical School.
Offering congratulations to Dr. Levine on his expanded role as Chief Patient Officer at Compass Pathways, Debbie Plotnick, Executive Vice President for State and Federal Advocacy at Mental Health America (MHA), stated, "Listening to people impacted by mental health conditions and prioritizing their needs and desires for new types of therapies, and working to assure access to them, are shared core values of Compass and MHA."
"I've spent my career pursuing better outcomes and experiences for those living with serious mental health conditions. At Compass, I believe we have an opportunity to transform lives by creating, and making accessible, truly new options," said Dr. Levine. "I am excited about the opportunity that I have in this new role to help transform patient care."
About Compass Pathways
Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are living with mental health challenges and who are not helped by existing standards of care. We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthesized psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).
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.
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, statements regarding our expectations regarding the impact of executive team appointments; the safety or efficacy of investigational COMP360 psilocybin treatment as a treatment for mental health conditions, including TRD, PTSD or anorexia nervosa; the potential for the pivotal phase 3 program in TRD or other trials to support regulatory filings and approvals; our ability to obtain regulatory approval and adequate coverage and reimbursement; our ability to transition from a clinical-stage to a commercial-stage organization and effectively launch a commercial product, if regulatory approval is obtained; and our expectations regarding the benefits of our investigational COMP360 psilocybin treatment . 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: uncertainties associated with risks related to clinical development which is a lengthy and expensive process with uncertain outcomes, and therefore our clinical trials may be delayed or terminated and may be more costly than expected; the results of early-stage clinical trials of our investigational COMP360 psilocybin treatment may not be predictive of the results of later stage clinical trials; our need for substantial additional funding to achieve our business goals and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our clinical trials; our efforts to obtain marketing approval from the applicable regulatory authorities in any jurisdiction for our investigational COMP360 psilocybin treatment may be unsuccessful; our efforts to commercialize and obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; our ability to successfully manage executive team changes and our ability to retain key personnel; and those risks and uncertainties described under the heading "Risk Factors" in Compass's most recent annual report on Form 10-K or quarterly report on Form 10-Q, the prospectus supplement related to the proposed public offering we plan to file and in other reports we have filed with the U.S. Securities and Exchange Commission ("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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250121036635/en/
Enquiries Â
Media: media@compasspathways.com
Investors: Stephen Schultz, stephen.schultz@compasspathways.com , +1 401 290 7324
News Provided by Business Wire via QuoteMedia
Compass Pathways Appoints Steve Levine, M.D., as Chief Patient Officer
Newly created role of Chief Patient Officer reinforces Compass' vision of working to achieve broad and equitable access to COMP360, if approved
Compass Pathways plc (Nasdaq: CMPS) ("Compass"), a biotechnology company dedicated to accelerating access to evidence-based innovation in mental health, today announced the appointment of Steve Levine, M.D., as Chief Patient Officer, effective immediately. In this newly developed executive team role, Dr. Levine will be responsible for ensuring that patient-centric strategies are embedded across the organization and that treatments and initiatives developed by the company are focused on addressing unmet needs in current clinical care and are designed to improve patient outcomes.
"Steve has spent the past four years working to deeply understand barriers to care for patients living with serious mental health conditions and he is committed to helping find solutions to address those barriers," said Kabir Nath, CEO of Compass Pathways. "Steve shares a passion for our mission to bring better options to people who urgently need them, and I am delighted to welcome him onto the executive leadership team and into the newly developed Chief Patient Officer role."
Dr. Levine has been a member of the Compass team since 2020, serving as Senior Vice President of Patient Access. Dr. Levine is a board-certified psychiatrist who has spent his career working across multiple facets of the healthcare system to improve people's lives through creating access to innovation. Dr. Levine completed his internship and residency in psychiatry at New York - Presbyterian Hospital/Weill Cornell Medical Center. He then completed a fellowship subspecialty training in psychosomatic medicine/psycho-oncology at Memorial Sloan Kettering Cancer Center/New York - Presbyterian Hospital. Prior to Compass, he led the company he founded in 2010, Actify Neurotherapies, that built new models of care delivery across the US for interventional psychiatry treatments. He has published extensively in both peer-reviewed journals and popular media, presented to both professional and lay audiences around the world, served in leadership roles for professional societies and not-for-profit entities, and received numerous awards for leadership and service. Dr. Levine is also an adjunct professor at Rutgers Medical School.
Offering congratulations to Dr. Levine on his expanded role as Chief Patient Officer at Compass Pathways, Debbie Plotnick, Executive Vice President for State and Federal Advocacy at Mental Health America (MHA), stated, "Listening to people impacted by mental health conditions and prioritizing their needs and desires for new types of therapies, and working to assure access to them, are shared core values of Compass and MHA."
"I've spent my career pursuing better outcomes and experiences for those living with serious mental health conditions. At Compass, I believe we have an opportunity to transform lives by creating, and making accessible, truly new options," said Dr. Levine. "I am excited about the opportunity that I have in this new role to help transform patient care."
About Compass Pathways
Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are living with mental health challenges and who are not helped by existing standards of care. We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthesized psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).
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.
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, statements regarding our expectations regarding the impact of executive team appointments; the safety or efficacy of investigational COMP360 psilocybin treatment as a treatment for mental health conditions, including TRD, PTSD or anorexia nervosa; the potential for the pivotal phase 3 program in TRD or other trials to support regulatory filings and approvals; our ability to obtain regulatory approval and adequate coverage and reimbursement; our ability to transition from a clinical-stage to a commercial-stage organization and effectively launch a commercial product, if regulatory approval is obtained; and our expectations regarding the benefits of our investigational COMP360 psilocybin treatment . 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: uncertainties associated with risks related to clinical development which is a lengthy and expensive process with uncertain outcomes, and therefore our clinical trials may be delayed or terminated and may be more costly than expected; the results of early-stage clinical trials of our investigational COMP360 psilocybin treatment may not be predictive of the results of later stage clinical trials; our need for substantial additional funding to achieve our business goals and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our clinical trials; our efforts to obtain marketing approval from the applicable regulatory authorities in any jurisdiction for our investigational COMP360 psilocybin treatment may be unsuccessful; our efforts to commercialize and obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; our ability to successfully manage executive team changes and our ability to retain key personnel; and those risks and uncertainties described under the heading "Risk Factors" in Compass's most recent annual report on Form 10-K or quarterly report on Form 10-Q, the prospectus supplement related to the proposed public offering we plan to file and in other reports we have filed with the U.S. Securities and Exchange Commission ("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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250121036635/en/
Enquiries Â
Media: media@compasspathways.com
Investors: Stephen Schultz, stephen.schultz@compasspathways.com , +1 401 290 7324
News Provided by Business Wire via QuoteMedia
Compass Pathways Announces Pricing of Underwritten Offering
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced the pricing of an underwritten offering of 24,014,728 American Depositary Shares ("ADSs") and in lieu of ADS, to certain institutional investors, pre-funded warrants to purchase up to 11,044,720 ADSs. Each ADS and pre-funded warrant shall be accompanied by a warrant ("ADS Warrant") to purchase one ADS, which has an exercise price of $5.796 per ADS, representing a 40% premium to the last sale price and will be exercisable following a specified data milestone. The offering price is $4.275 per ADS and accompanying ADS Warrant, and $4.2649 per pre-funded warrant and accompanying ADS Warrant. All of the securities are to be sold by Compass. The offering is expected to close on or about January 13, 2025, subject to satisfaction of customary closing conditions.
The offering was led by Deep Track Capital and included participation from high quality new and existing investors.
The gross proceeds to Compass from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $150 million, and up to approximately $353 million if the ADS Warrants are fully exercised for cash.
Compass intends to use the net proceeds from this offering, together with its existing cash and cash equivalents to fund its ongoing COMP005 and COMP006 Phase 3 trials in treatment-resistant depression with data expected in the second quarter of 2025 and second half of 2026, respectively. Net proceeds will also be used to accelerate a late-stage development program in PTSD, and for working capital and general corporate purposes.
TD Cowen, Cantor, Stifel and RBC Capital Markets are joint book running managers for the offering.
The securities are being offered by Compass Pathways pursuant to a Registration Statement on Form S-3 (File no. 333-282522) previously filed on October 7, 2024 and declared effective by the SEC on October 17, 2024, and Compass Pathways will also file a final prospectus supplement and accompanying prospectus relating to and describing the terms of the offering with the SEC. These documents can be accessed for free through the SEC's website at www.sec.gov .
When available, copies of the prospectus supplement and the accompanying prospectus relating to this offering may also be obtained from: TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, New York 10017, by telephone at (855) 495-9846 or by email at TD.ECM_Prospectus@tdsecurities.com ; Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, New York, 10022, or by email at prospectus@cantor.com ; Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, by telephone at (415) 364-2720 or by email at syndprospectus@stifel.com ; or RBC Capital Markets, LLC, Attention: Equity Syndicate Department, 200 Vesey Street, 8th Floor, New York, New York 10281; by phone at (877) 822-4089 or by email at equityprospectus@rbccm.com .
This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful before registration or qualification under the securities laws of that state or jurisdiction.
About Compass Pathways
Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are living with mental health challenges and who are not helped by existing standards of care. We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).
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.
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, statements regarding the completion of the offering on the anticipated terms or at all, the size and terms of the offering, the timing of the closing of the offering, the anticipated proceeds to be received in the offering (including, without limitation, the proceeds, if any, from the exercise of the warrants) and the expected use of such proceeds. 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: uncertainties associated with our ability to complete this offering on the anticipated terms or at all, including the satisfaction of customary closing conditions; general economic and market conditions and we may not receive any additional funds upon the exercise of the ADS warrants; as well as risks and uncertainties inherent in our business including risks related to clinical development which is a lengthy and expensive process with uncertain outcomes, and therefore our clinical trials may be delayed or terminated and may be more costly than expected; we will require substantial additional funding to achieve our business goals and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our clinical trials; and those risks and uncertainties described under the heading "Risk Factors" in Compass's most recent annual report on Form 10-K or quarterly report on Form 10-Q, the prospectus supplement related to the proposed public offering we plan to file and in other reports we have filed with the U.S. Securities and Exchange Commission ("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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250110715215/en/
Enquiries Â
Media: media@compasspathways.com ,
Investors: Stephen Schultz, stephen.schultz@compasspathways.com , +1 401 290 7324
News Provided by Business Wire via QuoteMedia
Compass Pathways Announces Pricing of Underwritten Offering
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced the pricing of an underwritten offering of 24,014,728 American Depositary Shares ("ADSs") and in lieu of ADS, to certain institutional investors, pre-funded warrants to purchase up to 11,044,720 ADSs. Each ADS and pre-funded warrant shall be accompanied by a warrant ("ADS Warrant") to purchase one ADS, which has an exercise price of $5.796 per ADS, representing a 40% premium to the last sale price and will be exercisable following a specified data milestone. The offering price is $4.275 per ADS and accompanying ADS Warrant, and $4.2649 per pre-funded warrant and accompanying ADS Warrant. All of the securities are to be sold by Compass. The offering is expected to close on or about January 13, 2025, subject to satisfaction of customary closing conditions.
The offering was led by Deep Track Capital and included participation from high quality new and existing investors.
The gross proceeds to Compass from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $150 million, and up to approximately $353 million if the ADS Warrants are fully exercised for cash.
Compass intends to use the net proceeds from this offering, together with its existing cash and cash equivalents to fund its ongoing COMP005 and COMP006 Phase 3 trials in treatment-resistant depression with data expected in the second quarter of 2025 and second half of 2026, respectively. Net proceeds will also be used to accelerate a late-stage development program in PTSD, and for working capital and general corporate purposes.
TD Cowen, Cantor, Stifel and RBC Capital Markets are joint book running managers for the offering.
The securities are being offered by Compass Pathways pursuant to a Registration Statement on Form S-3 (File no. 333-282522) previously filed on October 7, 2024 and declared effective by the SEC on October 17, 2024, and Compass Pathways will also file a final prospectus supplement and accompanying prospectus relating to and describing the terms of the offering with the SEC. These documents can be accessed for free through the SEC's website at www.sec.gov .
When available, copies of the prospectus supplement and the accompanying prospectus relating to this offering may also be obtained from: TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, New York 10017, by telephone at (855) 495-9846 or by email at TD.ECM_Prospectus@tdsecurities.com ; Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, New York, 10022, or by email at prospectus@cantor.com ; Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, by telephone at (415) 364-2720 or by email at syndprospectus@stifel.com ; or RBC Capital Markets, LLC, Attention: Equity Syndicate Department, 200 Vesey Street, 8th Floor, New York, New York 10281; by phone at (877) 822-4089 or by email at equityprospectus@rbccm.com .
This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful before registration or qualification under the securities laws of that state or jurisdiction.
About Compass Pathways
Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are living with mental health challenges and who are not helped by existing standards of care. We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).
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.
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, statements regarding the completion of the offering on the anticipated terms or at all, the size and terms of the offering, the timing of the closing of the offering, the anticipated proceeds to be received in the offering (including, without limitation, the proceeds, if any, from the exercise of the warrants) and the expected use of such proceeds. 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: uncertainties associated with our ability to complete this offering on the anticipated terms or at all, including the satisfaction of customary closing conditions; general economic and market conditions and we may not receive any additional funds upon the exercise of the ADS warrants; as well as risks and uncertainties inherent in our business including risks related to clinical development which is a lengthy and expensive process with uncertain outcomes, and therefore our clinical trials may be delayed or terminated and may be more costly than expected; we will require substantial additional funding to achieve our business goals and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our clinical trials; and those risks and uncertainties described under the heading "Risk Factors" in Compass's most recent annual report on Form 10-K or quarterly report on Form 10-Q, the prospectus supplement related to the proposed public offering we plan to file and in other reports we have filed with the U.S. Securities and Exchange Commission ("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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250110715215/en/
Enquiries Â
Media: media@compasspathways.com ,
Investors: Stephen Schultz, stephen.schultz@compasspathways.com , +1 401 290 7324
News Provided by Business Wire via QuoteMedia
Compass Pathways to Participate in December Investor Conferences
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that members of the executive management team will participate in the following investor conferences in addition to hosting investor meetings:
- 7 th Annual Evercore ISI HealthCONx Conference: Fireside chat at 10:25am ET on December 3, 2024
- Piper Sandler 36 th Annual Healthcare Conference: Fireside chat at 3:30pm ET on December 4, 2024
A live audio webcast of these events will be accessible here for 30 days following the events.
About Compass Pathways
Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are living with mental health challenges and who are not helped by existing standards of care. We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).
We have commenced a phase 3 clinical program of COMP360 psilocybin treatment in TRD, the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing a statistically significant (p
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.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241125241648/en/
Enquiries Â
Media: Sally Bain, sally.bain@compasspathways.com , + 1 781 458 0443
Investors: Stephen Schultz, stephen.schultz@compasspathways.com , +1 401 290 7324
News Provided by Business Wire via QuoteMedia
Compass Pathways to participate in Stifel 2024 Healthcare Conference
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that management will present at the Stifel 2024 Healthcare Conference at 10:55 am ET on November 19, 2024.
A live audio webcast of the presentation will be accessible from the "Events" page of the Investors section of the Compass website. A replay of the webcast will be accessible for 30 days following each event.
About Compass Pathways
Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are living with mental health challenges and who are not helped by existing standards of care. We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).
We have commenced a phase 3 clinical program of COMP360 psilocybin treatment in TRD, the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing a statistically significant (p
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.
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: Sally Bain, media@compasspathways.com , + 1 781 458 0443
Investors: Stephen Schultz, stephen.schultz@compasspathways.com , +1 401 290 7324
News Provided by GlobeNewswire via QuoteMedia
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