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Effective immediately, Albert Labs International Corp. will be reinstated for trading.
The Company has rectified the situation that gave rise to the suspension.
CSE Bulletin: Reinstatement - Albert Labs International Corp.
_________________________________
Avec effet immédiat, Albert Labs International Corp. sera réintégré aux fins de négociation.
La Société a rectifié la situation ayant donné lieu à la suspension.
| Date : | Le 7 juillet/July 2023 |
| Symbol(s)/Symbole(s) : | ABRT |
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If you have any questions or require further information please contact Listings at (416) 367-7340 or E-mail: Listings@thecse.com.
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Canadian Investment Regulatory Organization Trade Resumption - ABRT
Trading resumes in:
Company: Albert Labs International Corp.
CSE Symbol: ABRT
All Issues: Yes
Resumption (ET): 12:00 PM
CIRO can make a decision to impose a temporary suspension (halt) of trading in a security of a publicly-listed company. Trading halts are implemented to ensure a fair and orderly market. CIRO is the national self-regulatory organization which oversees all investment dealers and trading activity on debt and equity marketplaces in Canada .
SOURCE Canadian Investment Regulatory Organization (CIRO) – Halts/Resumptions
View original content: https://www.newswire.ca/en/releases/archive/July2023/07/c3496.html
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Albert Labs Receives preliminary acceptance of 35 Novel Inventive Claims for Patent Protected Manufacturing Technology
- Albert Labs has received preliminary acceptance of 35 novel inventive claims as part of its published International PCT Patent Application (No. PCT/CA2022/051281).
- The Company's proprietary manufacturing methodology, developed and validated in-house at Albert Labs' Vancouver facility, facilitates the production and scaling of highly potent yields of its KRN Active Pharmaceutical Ingredient (API).
- This protected technology provides industry-leading outputs of psilocybin, with sixteen times the amount of psilocybin per mass unit of mycelia. It also ensures standardization, consistency, and a reduced risk of contamination from research to commercial GMP production levels.
- Albert Labs is at the forefront of pharmaceutical-grade psilocybin manufacturing, providing long-term value throughout targeted clinical milestones and across key jurisdictions and licence indications.
Albert Labs International Corp. (CSE: ABRT) (the "Company" or "Albert Labs"), a fully-integrated biopharmaceutical drug discovery company bringing innovative medicines to patients with unmet mental health needs, is pleased to announce the preliminary acceptance of 35 novel inventive claims to comply with PCT 33(3) under its International PCT Patent Application (No. PCTCA2022051281).
Led by inventors Ali Gulamhusein , Dr. Jean Saayman , and Chand Jagpal , the Albert Labs team has validated a proprietary manufacturing technology that facilitates the production and scaling of highly potent yields of fungi biomass. It is currently used to manufacture the fungi biomass for KRN-101, a fixed-ratio unique medicine which contains a spectrum of key metabolites, including psilocybin and baeocystin.
The acceptance of novel inventive claims under the PCT is an important tool that secures effective and robust protection for their inventions in multiple countries.
This technology provides industry-leading outputs of psilocybin, with sixteen times the amount of psilocybin per mass unit of mycelia, while also ensuring standardization, consistency, and a reduced risk of contamination from research to commercial GMP production levels.
It is used for the production of fungi biomass in bioreactors and includes a novel method of increasing the yield of mycelium in a stirred tank with artificial substrates, providing protection from shear forces, and increasing growth. Furthermore, the novel methodology ensures less clumping and pelletization, with increased access to oxygen and nutrients encouraging large-scale biomass production.
There are several advantages to mycelium growth compared to farmed fruiting body growth for psilocybin production, including higher yields, faster growth, easier manipulation, lower contamination risk, and more sustainable production. This is an ideal production technology for a GMP laboratory facility compared to fruiting body growth.
This technology places Albert Labs at the forefront of pharmaceutical-grade psilocybin manufacturing, reducing the cost of production and increasing the ability to scale. This provides the Company with retained, long-term value throughout targeted clinical milestones and across key jurisdictions and licence indications.
Follow the links here to view our published Patent Application , and International Search Report and Written Opinion .
Business of Albert Labs International Corp.
Albert Labs is a fully-integrated biopharmaceutical drug discovery company bringing innovative medicines to patients with unmet mental health needs. Its team of experts leverage advanced culture technology and natural extraction, coupled with a comprehensive regulatory approach, to accelerate the development of mental health drugs, for which patient needs are both urgent and unmet. Albert Labs looks to develop solutions through an approved, fast-track clinical pathway focusing on Real World Evidence (RWE). RWE studies are a recognised clinical pathway, heavily used in oncology and recently, in the successful development of COVID-19 vaccines.
Through collaborations with research institutions, hospital centres and government agencies, Albert Labs uses existing clinical infrastructure to deliver and improve patient access to its treatment. Albert Labs' first drug target, KRN-101, is a potential solution for cancer-related anxiety, a market of over 15 million people with roughly 1 million new sufferers each year. From this initial focus, Albert Labs will address broader mental health concerns, reported to affect over a billion people worldwide.
The Company's goal is to deliver effective medicines to those who suffer with their mental health in the shortest possible time without compromising safety and/or quality, while also providing significant returns to shareholders.
Albert Labs (CSE: ABRT) (FSE: VB50) is publicly listed on the Canadian Securities Exchange (CSE) .
You can find more details about Albert Labs on our website here .
ON BEHALF OF THE BOARD OF DIRECTORS
Albert Labs International Corp.
 Dr. Michael Raymont
 Chief Executive Officer, Chairman
Cautionary Statement
This news release includes forward-looking statements that are subject to assumptions, risks, and uncertainties. Statements in this news release that are not purely historical are forward-looking statements, including without limitation any statements concerning the Company's intentions, plans, estimates, beliefs, or expectations regarding the future. Although the Company believes that any such intentions, plans, estimates, beliefs, and expectations in this news release are reasonable, there can be no assurance that any such intentions, plans, beliefs, and expectations will prove to be accurate.
The Company cautions readers that all forward-looking statements, including without limitation those relating to the Company's future operations and business prospects, are based on assumptions none of which can be assured, and are subject to certain risks and uncertainties that could cause actual events or results to differ materially from those indicated in the forward-looking statements. Readers are advised to rely on their evaluation of such risks and uncertainties and should not place undue reliance on forward-looking statements.
Any forward-looking statements are made as of the date of this news release, and the Company assumes no obligation to update the forward-looking statements or to update the reasons why actual events or results could or do differ from those projected in the forward-looking statements. The Company assumes no obligations to update any forward-looking statements, whether as a result of new information, future events, or otherwise unless required by the applicable securities laws.
SOURCE Albert Labs International Corp.
View original content to download multimedia: https://www.newswire.ca/en/releases/archive/May2023/02/c1221.html
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Albert Labs announces Private Placement - April 24, 2023
- Albert Labs has announced a private placement for gross proceeds of up to CAD $3,000,000 , with the first tranche offered at CAD $0.08 /Unit
- 80% of the Company's First In-Human trial has funding arranged, including a cash rebate from the Australian Government for an estimated CAD $1,200,000 (43.5% of eligible trial costs) , and a CAD $830,000 strategic investment from Cantheon Capital LLC .
- Proceeds will be used for:
- KRN-101 Toxicology and First In-Human trials in 2023
- Clinical Trial Application for its late-stage Real World Evidence trials in the United Kingdom (MHRA)
- IND Filing (FDA)
- Implementation of Expanded Drug Discovery Pipeline
- OTC Quotation and Investor Relations Programme
- G&A
- If you are interested in participating in this financing round, please contact us at: ir@albertlabs.com
Albert Labs International Corp. (CSE: ABRT) (the "Company" or "Albert Labs"), a fully-integrated biopharmaceutical company bringing innovative prescription medicines to patients with unmet mental health needs, has announced a non-brokered private placement for gross proceeds of up to CAD $3,000,000 (the "Offering").
The first tranche of the Offering is at a price of CAD $0.08 per Unit (the "Units"), with intermediate closings taking place as determined by the Company.
Gross proceeds raised will be used for pharmacokinetic and toxicology studies to advance the Company's primary drug target, the natural psilocybin-based KRN-101, towards it's Real World Evidence trial for regulatory approval in the United Kingdom and IND filing in the United States ; the proceeds will also be used for an OTC quotation, investor relations programme, general and administrative expenses and any financing fees.
Each Unit is comprised of one common share (the "Common Share") and one-half of one whole Common Share purchase warrant (each whole warrant, a "Warrant") with each whole Warrant entitling the holder to purchase one additional Common Share of the Company at a price of CAD $0.12 per Share for a period of 12 months from the date of issuance. In the event that the Company's common shares have a closing price on the CSE of greater than CAD $0.15 per common share for a period of 10 consecutive trading days, the Company may accelerate the expiry date of the Warrants by giving notice to the holders thereof and, in such case, the Warrants will expire on the 30th day after the date on which such notice is given to the holder by the Company.
All securities issued in connection with the Offering will be subject to a hold period of four months plus a day from the date of issuance and the resale rules of applicable securities legislation.
Business of Albert Labs International Corp.
Albert Labs is a fully-integrated biopharmaceutical company bringing innovative prescription medicines to patients with unmet mental health needs. Its team of experts leverage advanced culture technology and natural extraction, coupled with a comprehensive regulatory approach, to accelerate the development of mental health drugs, for which patient needs are both urgent and unmet. Albert Labs looks to develop solutions through an approved, fast-track clinical pathway focusing on Real World Evidence (RWE). RWE studies are a recognised clinical pathway, heavily used in oncology and recently, in the successful development of COVID-19 vaccines.
Through collaborations with research institutions, hospital centres and government agencies, Albert Labs uses existing clinical infrastructure to deliver and improve patient access to its treatment. Albert Labs' first drug target, KRN-101, is a potential solution for cancer-related anxiety, a market of over 15 million people with roughly 1 million new sufferers each year. From this initial focus, Albert Labs will address broader mental health concerns, reported to affect over a billion people worldwide.
The company's goal is to deliver effective medicines to those who suffer with their mental health in the shortest possible time without compromising safety and/or quality, while also providing significant returns to shareholders.
Albert Labs (CSE: ABRT) (FSE: VB50) is publicly listed on the Canadian Securities Exchange (CSE).
You can find more details about Albert Labs on our website here.
ON BEHALF OF THE BOARD OF DIRECTORS
Albert Labs International Corp.
Dr. Michael Raymont
Chief Executive Officer, Chairman
Cautionary Statement
This news release includes forward-looking statements that are subject to assumptions, risks, and uncertainties. Statements in this news release that are not purely historical are forward-looking statements, including without limitation any statements concerning the Company's intentions, plans, estimates, beliefs, or expectations regarding the future. Although the Company believes that any such intentions, plans, estimates, beliefs, and expectations in this news release are reasonable, there can be no assurance that any such intentions, plans, beliefs, and expectations will prove to be accurate.
The Company cautions readers that all forward-looking statements, including without limitation those relating to the Company's future operations and business prospects, are based on assumptions none of which can be assured, and are subject to certain risks and uncertainties that could cause actual events or results to differ materially from those indicated in the forward-looking statements. Readers are advised to rely on their evaluation of such risks and uncertainties and should not place undue reliance on forward-looking statements.
Any forward-looking statements are made as of the date of this news release, and the Company assumes no obligation to update the forward-looking statements or to update the reasons why actual events or results could or do differ from those projected in the forward-looking statements. The Company assumes no obligations to update any forward-looking statements, whether as a result of new information, future events, or otherwise unless required by the applicable securities laws.
SOURCE Albert Labs International Corp.
View original content to download multimedia: https://www.newswire.ca/en/releases/archive/April2023/24/c3868.html
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Albert Labs announces Strategic Investment from Cantheon Capital LLC for First In-Human Trials
Highlights:
- Cantheon Capital, one of the largest global pharmaceutical psychedelics venture capital firms, sign terms for ~CA$830,000 (£500,000) of funding to Albert Labs , allocated towards its first in-human clinical trials in 2023
- Albert Labs is nearing their first in-human studies on its primary drug candidate, KRN-101, a psilocybin-based, natural pharmaceutical product
- Albert Labs' first human trials, due to commence in Q2 2023, will be carried out in partnership with industry leading clinical research partner, iNGENu CRO as previously announced . The trials will take place in Australia , providing the Company with the additional benefit of access to a 43.5% cash reimbursement on all eligible related costs equating to a further benefit of ~CA$1.2 million
- Albert Labs recognised in Canadian Venture for "Revolutionizing Mental Health Drug Development"
Albert Labs International Corp. (CSE: ABRT), the "Company" or "Albert Labs"), a fully-integrated biopharmaceutical company bringing innovative prescription medicines to patients with unmet mental health needs, has announced a strategic investment from prominent psychedelic pharmaceutical investment fund, Cantheon Capital LLC ("Cantheon Capital").
On 23 March 2023 , the Company entered into an agreement which sees Cantheon Capital sign funding terms for ~CA$830,000 (£500,000) of Convertible Debentures to support financing of Albert Labs' forthcoming clinical trials in 2023.
Cantheon Capital's investment mandate is focussed on pharmaceutical companies with near term catalysts for high-value generation, deploying capital to support with achieving major drug development milestones.
This investment comes on the cusp of the third major milestone for Albert Labs . The first, an extensive drug discovery programme, the second, the completion of pre-clinical studies, and the third, to be commenced shortly, being KRN-101 administered to humans for the first time.
KRN-101 is an IP-protected, psilocybin-based pharmaceutical product, for which Albert Labs will seek regulatory approval across global medical regulatory jurisdictions.
This investment will be entirely allocated towards Albert Labs' first in-human studies, to be conducted by iNGENu in Australia , which are due to take place in Q2 2023 .
- From commencement to completion (including clinical outputs), the study will run for 3-months
- The study will cost a total of ~CA$2.7 million, and will be funded through:
- Cantheon Capital investment of: ~CA$830,000
- Australian Government R&D rebate (43.5% of eligible costs): ~CA$1.2 million
- Albert Labs cash contribution: ~CA$670,000
- Upon completion KRN-101 will be validated as a safe pharmaceutical product
- This study will enable submissions for late-stage Real World Evidence trials in the United Kingdom and the United States , pursuing Special Access Programs' and accelerated licensing
Aaron Ray , General Partner of Cantheon Capital, commented: "We are pleased to partner with Albert Labs and excited by what we see as a huge growth proposition for 2023. First in-human studies are significant for any early-stage pharmaceutical company. Reaching this milestone is reflective of the incredible amount of work that has gone into delivering KRN-101. The company will benefit greatly from carrying out these trials in Australia with iNGENu, the leading CRO for the burgeoning entheogen drug development space.
Beyond the investment itself, we look forward to supporting the company with our deep expertise in pharmaceutical research and commercialization. We are highly selective in the companies we choose to invest into but in the case of Albert Labs , we were attracted by their ability to accelerate product through the regulatory channels and clinical trials pathways to hasten the timeline to commercialization."
Dr. Michael Raymont , CEO of Albert Labs , stated: "We are delighted to come to this agreement with Cantheon Capital, one of the most sophisticated later stage psychedelics venture capital firms in the world, and feel it serves as a real statement of confidence in our growth as a company and the upside potential of our product that will help improves the lives of millions of patients globally. We are a differentiated offering within the industry, holding extensive intellectual property protection and a unique regulatory strategy focussed on speed to market. We look forward to building upon the significant progress to date with some key clinical milestones in the year ahead."
Further to the announcement of this investment, Albert Labs has been recognised in Canadian Venture for "Revolutionizing Mental Health Drug Development".
Canadian Venture commented:
- " Albert Labs is a leading pharmaceutical drug development company that is revolutionizing mental health drug development."
- "It's team of experts leverage advanced culture technology and natural extraction, coupled with a comprehensive regulatory approach, to accelerate the development of mental health drugs."
Are you an Albert Labs investor yet? Let's talk.
+1 877 859 3684
Convertible Debentures
Cantheon Capital has signed terms with Albert Labs for an aggregate investment of GB£500,000 (~CA$830,000), provided in two (2) tranches, relating to their upcoming first in-human clinical trials. The tranches of the Convertible Debentures will be triggered by the commencement and first dosing events in the trials, which will evaluate Albert Labs' proprietary psilocybin-based pharmaceutical product, KRN-101.
The Convertible Debenture conversion price, if executed, shall be at a 20% discount to the closing price of the Company's common stock 20-day VWAP trading average, as quoted on the Canadian Securities Exchange ("CSE") the effective day of the Convertible Debenture, subject to a minimum of $0.05 (the "Conversion Price"). They include a 10% interest rate paid in cash annually in arrears, with an option to pay at the Company's election within the first 6 months of closing, subject to a 3% prepayment penalty. The Convertible Debentures include 100% warrant cover, exercisable at the same conversion price as the common shares upon issue, as approved by the CSE. In accordance with the terms, the conversion price per Common Share shall be adjusted to ensure that Cantheon and its affiliates shall not beneficially own, or have control or direction over, Common Shares in excess of 19.99% of the number of Common Shares issued and outstanding immediately after giving effect to the issuance of Common Shares issuable under the applicable tranche.
Completion of the Convertible Debentures remain subject to the final agreement and regulatory approvals, including from the CSE.
Business of Albert Labs International Corp.
Albert Labs is a fully-integrated biopharmaceutical company bringing innovative prescription medicines to patients with unmet mental health needs. Its team of experts leverage advanced culture technology and natural extraction, coupled with a comprehensive regulatory approach, to accelerate the development of mental health drugs, for which patient needs are both urgent and unmet. Albert Labs looks to develop solutions through an approved, fast-track clinical pathway focusing on Real World Evidence (RWE). RWE studies are a recognised clinical pathway, heavily used in oncology and recently, in the successful development of COVID-19 vaccines.
Through collaborations with research institutions, hospital centres and government agencies, Albert Labs uses existing clinical infrastructure to deliver and improve patient access to its treatment. Albert Labs' first drug target, KRN-101, is a potential solution for cancer-related anxiety, a market of over 15 million people with roughly 1 million new sufferers each year. From this initial focus, Albert Labs will address broader mental health concerns, reported to affect over a billion people worldwide.
The company's goal is to deliver effective medicines to those who suffer with their mental health in the shortest possible time without compromising safety and/or quality, while also providing significant returns to shareholders.
Albert Labs (CSE: ABRT) (FSE: VB50) is publicly listed on the Canadian Securities Exchange (CSE) .
You can find more details about Albert Labs on our website here .
ON BEHALF OF THE BOARD OF DIRECTORS
Albert Labs International Corp.
Dr. Michael Raymont
Chief Executive Officer, Chairman
Cautionary Statement
This news release includes forward-looking statements that are subject to assumptions, risks, and uncertainties. Statements in this news release that are not purely historical are forward-looking statements, including without limitation any statements concerning the Company's intentions, plans, estimates, beliefs, or expectations regarding the future. Although the Company believes that any such intentions, plans, estimates, beliefs, and expectations in this news release are reasonable, there can be no assurance that any such intentions, plans, beliefs, and expectations will prove to be accurate.
The Company cautions readers that all forward-looking statements, including without limitation those relating to the Company's future operations and business prospects, are based on assumptions none of which can be assured, and are subject to certain risks and uncertainties that could cause actual events or results to differ materially from those indicated in the forward-looking statements. Readers are advised to rely on their evaluation of such risks and uncertainties and should not place undue reliance on forward-looking statements.
Any forward-looking statements are made as of the date of this news release, and the Company assumes no obligation to update the forward-looking statements or to update the reasons why actual events or results could or do differ from those projected in the forward-looking statements. The Company assumes no obligations to update any forward-looking statements, whether as a result of new information, future events, or otherwise unless required by the applicable securities laws.
SOURCE Albert Labs International Corp.
View original content to download multimedia: https://www.newswire.ca/en/releases/archive/March2023/28/c6495.html
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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 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