Engages Thrive Health, a Leading Digital Patient Care Platform to Streamline Care Programs and Data Collection
NeonMind Biosciences Inc. (CSE:NEON)(OTCQB:NMDBD)(FRA:6UF) ("NeonMind'' or the "Company"), announced today it has advanced its strategy to streamline access to treatments at its specialty mental health clinics with Thrive Health in preparation of opening its inaugural clinic located in Mississauga, Ontario
The recent inclusion of intravenous ketamine for mood and anxiety disorders (IV-Ket) in the Canadian guidelines as a recommended treatment is a testament to the value of this treatment, and a growing number of institutions are providing coverage for IV-Ket treatment, setting the precedent for further coverage. Using Thrive Health's robust care management platform to collect patient profiles, manage care programs, and measure treatment outcomes allows us to improve payment coverage for our treatments and better serve our patients.
"We are seeing greater institutional coverage for IV-Ket treatment which is a testament to the treatment's value to the health system," said Rob Tessarolo, President & CEO of NeonMind. "Institutional reimbursement validates the treatment in Canada, and we are primed for increased demand for this treatment".
Rob Tessarolo also added, "NeonMind is focused on improving treatment outcomes and being able to collect and analyze treatment data throughout our network of clinics will provide a more robust value story for adoption of our treatments and establishing payment coverage for our patients. Working with leading digital healthcare platforms such as Thrive Health enables us to deploy our strategies with scale."
NeonMind will be working with Thrive Health, a trusted digital care platform used by many hospitals and clinics and selected as the official partner by Health Canada in the development of the Canada COVID-19 app.
NeonMind's inaugural specialty mental health clinic is located at 89 Queensway West, Suite 604, Mississauga, Ontario, L5B 2V2. For more information related to NeonMind's specialty clinics, please email medicalinformation@neonmind.com.
About Thrive Health Inc.
Thrive Health was founded in 2016 by a diverse group of patients, clinicians, researchers, parents, and students who came together to help patients going through complex health journeys, working to put people at the center of their care. Thrive's platform powers health, wellness and care solutions for organizations by empowering individuals with compelling digital experiences. Thrive operates across North America, headquartered in Vancouver BC, and is on a mission to make healthcare work better for everyone.
For more information about Thrive Health, visit https://welcome.thrive.health/
About NeonMind Biosciences Inc.
NeonMind operates two divisions: (i) a pharmaceutical division engaged in drug development of psychedelic compounds with two lead psilocybin-based drug candidates targeting obesity; and (ii) a medical services division focused on launching specialty mental health clinics that integrate psychedelic therapeutics into traditional psychotherapy settings.
In its pharmaceutical division, NeonMind has two distinct psilocybin drug development programs targeting obesity. NeonMind's lead candidate, NEO-001, employs psilocybin as an agonist at the serotonin 5- HT2A receptor, which is involved in the hallucinogenic effect of psychedelics. The Company's second drug candidate, NEO-002, employs low-dose psilocybin as an agonist at the 5-HT2C receptor, which controls appetite.
NeonMind and its strategic partners are building NeonMind-branded specialty mental health clinics in Canada that incorporate evidence-backed innovative treatments to address a variety of mental health needs. For more information on NeonMind, visit www.NeonMindBiosciences.com.
CONTACT:
Rob Tessarolo, President & Chief Executive Officer, NeonMind Biosciences Inc.
rob@neonmind.com
Tel: 416-750-3101
The Canadian Securities Exchange has not reviewed, approved nor disapproved the contents of this news release.
Cautionary Statement Regarding Forward-Looking Statements
Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or NeonMind's future performance. The use of any of the words "could", "expect", "believe", "will", "projected", "estimated" and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on NeonMind's current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, NeonMind's drug development plans, its ability to retain key personnel, and its expectation as to the development of its intellectual property and other steps in its preclinical and clinical drug development constitute forward-looking information. Actual results and developments may differ materially from those contemplated by forward-looking information. Readers are cautioned not to place undue reliance on forward-looking information. The statements made in this press release are made as of the date hereof. NeonMind disclaims any intention or obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as may be expressly required by applicable securities laws.
SOURCE: NeonMind Biosciences Inc.
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Initiates Medical Adoption Program with Impetus Digital, a Leading Healthcare Platform for Virtual Medical Education
NeonMind Biosciences Inc. (CSE:NEON)(OTCQB:NMDBD)(FRA:6UF) ("NeonMind'' or the "Company"), an integrated drug development and wellness company focused on bringing innovative psychedelic-based treatments to people suffering from obesity and mental health disorders, announced today it has advanced its strategy to enhance access to treatments at its specialty mental health clinics with Impetus Digital in preparation of opening its inaugural clinic located in Mississauga, Ontario
Intravenous ketamine for mood and anxiety disorders (IV-Ket) was recently included in the Canadian guidelines as a recommended treatment. As a testament to the value of IV-Ket treatments, a growing number of prescribers and their patients are seeking access to this treatment with further opportunities to expand the prescriber base through medical education.
"This is an exciting time for this ground-breaking treatment in Canada as success in adopting novel treatments is vastly enhanced by strong clinical evidence," said Rob Tessarolo, President & CEO of NeonMind. "Guideline inclusion means that Canadian medical leadership has reviewed the evidence and recommend the use of IV-Ket for treatment".
Rob Tessarolo also added "NeonMind is now focused on improving availability of access points for IV-Ket treatments with its setup of a network of clinic locations throughout Canada in partnership with leading specialty treatment companies with hundreds of clinic locations already established. We are also focusing on improving education and adoption of our treatments using proven commercial strategies. Working with a leading digital platform provider such as Impetus Digital will help disseminate medical education and enhance adoption of this important treatment".
NeonMind will be working with Impetus Digital's InSite Platform®, a trusted platform for virtual medical education to enhance adoption of IV-Ket treatments. This platform will enable us to establish prescriber confidence to include IV-Ket in their treatment toolset and how to refer patients to NeonMind clinics. Impetus Digital has been integral in successful pharmaceutical and healthcare treatment launches in Canada.
NeonMind's inaugural specialty mental health clinic is located at 89 Queensway West, Suite 604, Mississauga, Ontario, L5B 2V2. For more information related to NeonMind's specialty clinics, please email medicalinformation@neonmind.com.
About Impetus Digital
Headquartered in Toronto, Ontario, Impetus Digital helps life science organizations across the globe virtualize their in-person meetings, events, and programs, including medical education and product launches. They do this through their best-in-class InSite Touchpoints™ and InSite Events™ offerings, delivered with White-Glove™ service and 360° coverage and care. Leveraging their large portfolio of cutting-edge, life science-specific online collaboration tools, clients can seamlessly gather insights from, and collaborate with, internal and external stakeholders. To find out more about Impetus Digital, visit www.impetusdigital.com or book a demo at www.meetwithimpetus.com
About NeonMind Biosciences Inc.
NeonMind operates two divisions: (i) a pharmaceutical division engaged in drug development of psychedelic compounds with two lead psilocybin-based drug candidates targeting obesity; and (ii) a medical services division focused on launching specialty mental health clinics that integrate psychedelic therapeutics into traditional psychotherapy settings.
In its pharmaceutical division, NeonMind has two distinct psilocybin drug development programs targeting obesity. NeonMind's lead candidate, NEO-001, employs psilocybin as an agonist at the serotonin 5- HT2A receptor, which is involved in the hallucinogenic effect of psychedelics. The Company's second drug candidate, NEO-002, employs low-dose psilocybin as an agonist at the 5-HT2C receptor, which controls appetite.
NeonMind and its strategic partners are building NeonMind-branded specialty mental health clinics in Canada that incorporate evidence-backed innovative treatments to address a variety of mental health needs. For more information on NeonMind, go to www.NeonMindBiosciences.com.
CONTACT:
Rob Tessarolo, President & Chief Executive Officer, NeonMind Biosciences Inc.
rob@neonmind.com
Tel: 416-750-3101
The Canadian Securities Exchange has not reviewed, approved nor disapproved the contents of this news release.
Cautionary Statement Regarding Forward-Looking Statements
Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or NeonMind's future performance. The use of any of the words "could", "expect", "believe", "will", "projected", "estimated" and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on NeonMind's current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, NeonMind's drug development plans, its ability to retain key personnel, and its expectation as to the development of its intellectual property and other steps in its preclinical and clinical drug development constitute forward-looking information. Actual results and developments may differ materially from those contemplated by forward-looking information. Readers are cautioned not to place undue reliance on forward-looking information. The statements made in this press release are made as of the date hereof. NeonMind disclaims any intention or obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as may be expressly required by applicable securities laws.
SOURCE:NeonMind Biosciences Inc.
News Provided by ACCESSWIRE via QuoteMedia
To Deliver Low Dose Intravenous Ketamine for Mood and Anxiety Disorders, a Recommended Treatment by Canadian Guidelines, Upon Clinic Licensing
NeonMind Biosciences Inc. (CSE:NEON)(OTCQB:NMDBF)(FRA:6UF) ("NeonMind'' or the "Company"), an integrated drug development and wellness company focused on bringing innovative psychedelic-based treatments to people suffering from obesity and mental health disorders, announced today it is setting up to offer low dose intravenous ketamine therapy for mood and anxiety disorders (IV-Ket) as an initial treatment at its recently announced, inaugural specialty mental health clinic location in Mississauga, Ontario, pending clinic licensing
NeonMind's Mississauga clinic represents its initiative to establish and operate a network of NeonMind-branded specialty clinics. These clinics will deliver in demand mental health treatments to underserved areas throughout Canada. Specialty services to be offered will incorporate innovative, evidence-based interventional psychiatric treatments for a variety of mental health disorders.
Rob Tessarolo, President & CEO of NeonMind, commented, "This represents the latest step in our plan to become a specialty mental health clinics operator. We are building a clinic infrastructure that supports psychiatric treatment using innovative medicines such as ketamine, as well as other emerging therapies with strong evidence of efficacy and safety, in an effort to provide long-lasting solutions to a growing population of patients suffering from mental health. Following our recent clinic opening announcements, we are working quickly to stand these facilities up, with our Mississauga location in the final process for equipment setup and licensing."
NeonMind's Site Medical Director for its Mississauga specialty clinic location, Dr. Bhayana, has low dose IV-Ket treatment for mood and anxiety disorders as part of his scope of practice and will be overseeing the clinic with three private infusion rooms and operational capabilities that can support high volumes of IV-Ket treatments. There is now strong clinical evidence that IV-Ket is an efficacious and safe treatment for mood and anxiety disorders which has led to its inclusion as a treatment option in Canadian guidelines. Additional psychedelic-based therapies have a growing body of evidence on their efficacy in treating mental health disorders and NeonMind will look to incorporate these novel therapies as they are authorized. The Mississauga clinic is expected to begin treatment services in the second half of 2022.
NeonMind's inaugural specialty mental health clinic is located at 89 Queensway West, Suite 604, Mississauga, Ontario, L5B 2V2. For more information related to NeonMind's specialty clinics, please email medicalinformation@neonmind.com.
About NeonMind Biosciences Inc.
NeonMind operates two divisions: (i) a pharmaceutical division engaged in drug development of psychedelic compounds with two lead psilocybin-based drug candidates targeting obesity; and (ii) a medical services division focused on launching specialty mental health clinics that integrate psychedelic therapeutics into traditional psychotherapy settings.
In its pharmaceutical division, NeonMind has two distinct psilocybin drug development programs targeting obesity. NeonMind's lead candidate, NEO-001, employs psilocybin as an agonist at the serotonin 5- HT2A receptor, which is involved in the hallucinogenic effect of psychedelics. The Company's second drug candidate, NEO-002, employs low-dose psilocybin as an agonist at the 5-HT2C receptor, which controls appetite.
NeonMind and its strategic partners are building NeonMind-branded specialty mental health clinics in Canada that incorporate evidence-backed innovative treatments to address a variety of mental health needs. For more information on NeonMind, go to www.NeonMindBiosciences.com.
Rob Tessarolo, President & Chief Executive Officer, NeonMind Biosciences Inc.
rob@neonmind.com
Tel: 416-750-3101
Investor Relations:
KCSA Strategic Communications
Scott Eckstein/Tim Regan
neonmind@kcsa.com
Tel: 212-896-1210
The Canadian Securities Exchange has not reviewed, approved nor disapproved the contents of this news release.
Cautionary Statement Regarding Forward-Looking Statements
Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or NeonMind's future performance. The use of any of the words "could", "expect", "believe", "will", "projected", "estimated" and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on NeonMind's current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, NeonMind's drug development plans, its ability to retain key personnel, and its expectation as to the development of its intellectual property and other steps in its preclinical and clinical drug development constitute forward-looking information. Actual results and developments may differ materially from those contemplated by forward-looking information. Readers are cautioned not to place undue reliance on forward-looking information. The statements made in this press release are made as of the date hereof. NeonMind disclaims any intention or obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as may be expressly required by applicable securities laws.
SOURCE: NeonMind Biosciences Inc.
News Provided by ACCESSWIRE via QuoteMedia
Data Further Validates Psilocybin as a Drug Candidate for Obesity and Supports Development of NeonMind's Drug Programs NEO-001 and NEO-002
NeonMind Biosciences Inc. (CSE:NEON)(OTCQB:NMDBF)(FRA:6UF) ("NeonMind'' or the "Company"), an integrated drug development and wellness company focused on bringing innovative psychedelic-based treatments to people suffering from obesity and mental health disorders, announced today it has released preclinical data demonstrating the efficacy of psilocybin in reducing weight gain in obese subjects. In previous preclinical studies, NeonMind has shown efficacy in reducing weight gain in healthy subjects with normal weight. This latest study suggests a broader therapeutic potential of psilocybin in weight management and supports the current development track of NeonMind's drug candidates
The data from NeonMind's preclinical models revealed a novel finding for its drug candidates: the ability to target visceral fat. Increased visceral fat is linked to poorer cardiometabolic health and reduction in this type of fat is important in weight loss and better overall health outcomes. Additional findings from the preclinical models in obese subjects include:
The positive results further reinforce the drug development opportunity of NeonMind's two lead psilocybin-based drug candidates targeting obesity. Moreover, the novel findings provide opportunities to enhance their commercial profiles. These candidates include NEO-001, which employs psilocybin as an agonist at the serotonin 5- HT2A receptor, and NEO-002, which utilizes low-dose psilocybin as an agonist at the 5-HT2C receptor, which controls appetite.
"These latest findings show psilocybin's ability to modulate weight gain, which is absolutely critical for any drug candidate targeting obesity and weight loss," said Robert Tessarolo, President & CEO of NeonMind. "In two separate rodent studies, we have shown that psilocybin has efficacy in modulating weight in both obese and normal subjects. This is important given visceral fat is associated with increased comorbidities and poorer health outcomes. These findings show promise for the future development of psilocybin-based treatments for obesity, which may also lead to improved cardiovascular and metabolic health."
Dr. Alasdair Barr, primary investigator of NeonMind's preclinical study, commented, "These preclinical studies are bringing to light novel findings in an under-researched psychedelic modality: psilocybin-based weight management. We were able to explore key mechanisms that drive obese behavior and have come away with further evidence that psilocybin could potentially lead to a reduction in weight gain in various patient sub-types."
The manuscript has been submitted to a leading industry peer-reviewed journal for publication.
About NeonMind Biosciences Inc.
NeonMind operates two divisions: (i) a pharmaceutical division engaged in drug development of psychedelic compounds with two lead psilocybin-based drug candidates targeting obesity; and (ii) a medical services division focused on launching specialty mental health clinics that integrate psychedelic therapeutics into traditional psychotherapy settings.
In its pharmaceutical division, NeonMind has two distinct psilocybin drug development programs targeting obesity. NeonMind's lead candidate, NEO-001, employs psilocybin as an agonist at the serotonin 5- HT2A receptor, which is involved in the hallucinogenic effect of psychedelics. The Company's second drug candidate, NEO-002, employs low-dose psilocybin as an agonist at the 5-HT2C receptor, which controls appetite.
NeonMind and its strategic partners are building NeonMind-branded specialty mental health clinics in Canada that incorporate evidence-backed innovative treatments to address a variety of mental health needs. For more information on NeonMind, go to www.NeonMindBiosciences.com.
Rob Tessarolo, President & Chief Executive Officer, NeonMind Biosciences Inc.
rob@neonmind.com
Tel: 416-750-3101
Investor Relations:
KCSA Strategic Communications
Scott Eckstein/Tim Regan
neonmind@kcsa.com
Tel: 212-896-1210
The Canadian Securities Exchange has not reviewed, approved nor disapproved the contents of this news release.
Cautionary Statement Regarding Forward-Looking Statements
Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or NeonMind's future performance. The use of any of the words "could", "expect", "believe", "will", "projected", "estimated" and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on NeonMind's current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, NeonMind's drug development plans, its ability to retain key personnel, and its expectation as to the development of its intellectual property and other steps in its preclinical and clinical drug development constitute forward-looking information. Actual results and developments may differ materially from those contemplated by forward-looking information. Readers are cautioned not to place undue reliance on forward-looking information. The statements made in this press release are made as of the date hereof. NeonMind disclaims any intention or obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as may be expressly required by applicable securities laws.
SOURCE:NeonMind Biosciences Inc.
News Provided by ACCESSWIRE via QuoteMedia
NeonMind Biosciences Inc. (CSE:NEON)(OTCQB:NMDBF)(FRA:6UF) ("NeonMind'' or the "Company"), an integrated drug development and wellness company focused on bringing innovative psychedelic-based treatments to people suffering from obesity and mental health disorders, announced today it has filed a new patent application with the United States Patent and Trademark Office related to a novel mechanism of weight loss targeted to specific fat subtypes
The provisional patent application includes data derived from NeonMind's recent preclinical animal study, incorporating novel findings which indicate, in addition to reiterating weight modulation effects of psilocybin seen in previous studies, that the targeted reduction of specific fat subtypes may have beneficial effects on metabolic and cardiovascular health. The filing strengthens NeonMind's growing IP portfolio and differentiates the commercial profiles of its drug candidates. The Company plans to release further details of the study's findings.
If granted, the patent could support NeonMind's pharmaceutical assets until at least 2042. NeonMind's lead candidate, NEO-001, aims to produce neuropharmacological changes induced by psilocybin, in conjunction with psychotherapy, to achieve durable weight loss for patients suffering from obesity. NeonMind's additional drug candidate, NEO-002, employs low-dose psilocybin to control appetite.
"We are excited by the unique findings from our preclinical studies, which have demonstrated durable therapeutic benefits for weight management in the animal model. Importantly, our novel findings provide an opportunity for us to develop drugs with highly differentiated target product profiles and broad commercial opportunities," said Robert Tessarolo, President & CEO of NeonMind. "With the advancement of our research programs and continued expansion of our IP portfolio, NeonMind is positioning itself as a leading innovator in the development of novel psychedelic treatments focused on serving the weight management and obesity market, which has historically been underserved and where a new, effective approach is desperately needed to help people live fuller, healthier lives."
About NeonMind Biosciences Inc.
NeonMind operates two divisions: (i) a pharmaceutical division engaged in drug development of psychedelic compounds with two lead psilocybin-based drug candidates targeting obesity; and (ii) a medical services division focused on launching specialty mental health clinics that integrate psychedelic therapeutics into traditional psychotherapy settings.
In its pharmaceutical division, NeonMind has two distinct psilocybin drug development programs targeting obesity. NeonMind's lead candidate, NEO-001, employs psilocybin as an agonist at the serotonin 5- HT2A receptor, which is involved in the hallucinogenic effect of psychedelics. The Company's second drug candidate, NEO-002, employs low-dose psilocybin as an agonist at the 5-HT2C receptor, which controls appetite.
NeonMind and its strategic partners are building NeonMind-branded specialty mental health clinics in Canada that incorporate evidence-backed innovative treatments to address a variety of mental health needs. For more information on NeonMind, go to www.NeonMindBiosciences.com.
Rob Tessarolo, President & Chief Executive Officer, NeonMind Biosciences Inc.
rob@neonmind.com
Tel: 416-750-3101
Investor Relations:
KCSA Strategic Communications
Scott Eckstein/Tim Regan
neonmind@kcsa.com
Tel: 212-896-1210
The Canadian Securities Exchange has not reviewed, approved nor disapproved the contents of this news release.
Cautionary Statement Regarding Forward-Looking Statements
Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or NeonMind's future performance. The use of any of the words "could", "expect", "believe", "will", "projected","estimated" and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on NeonMind's current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, NeonMind's drug development plans, its ability to retain key personnel, and its expectation as to the development of its intellectual property and other steps in its preclinical and clinical drug development constitute forward-looking information. Actual results and developments may differ materially from those contemplated by forward-looking information. Readers are cautioned not to place undue reliance on forward-looking information. The statements made in this press release are made as of the date hereof. NeonMind disclaims any intention or obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as may be expressly required by applicable securities laws.
SOURCE:NeonMind Biosciences Inc.
News Provided by ACCESSWIRE via QuoteMedia
Highlights:
COMPASS Pathways Plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported its financial results for the first quarter 2025 and provided an update on recent progress across its business.
"We eagerly await the upcoming topline 6-week data readout, on track for late June, the first data from our pivotal phase 3 COMP360 program in treatment resistant depression." said Kabir Nath, Chief Executive Officer. "Our continued progress reinforces Compass' leadership in psychedelic therapy development, which we believe represents the next generation of mental health therapeutic options and can lead to significant value creation."
Business Highlights
COMP360 psilocybin treatment in TRD (Treatment Resistant Depression)
COMP360 psilocybin treatment in PTSD (Post Traumatic Stress Disorder)
Financial highlights
Financial Guidance
Full year 2025 net cash used in operating activities is expected to be in the range of $120 million to $145 million. The cash position at March 31, 2025 is expected to be sufficient to fund operating expenses and capital expenditure requirements at least through the planned 26-week data read-out from the COMP006 study, which is expected in the second half of 2026.
Conference call
The management team will host a conference call at 8:00 am ET (1:00 pm UK) on May 8, 2025. A live webcast of the call will be available on the Compass Pathways website at First Quarter 2025 Financial Results .
About Compass Pathways
COMPASS Pathways Plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthesized psilocybin treatment, potentially a first in class treatment. 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. We envision a world where mental health means not just the absence of illness but the ability to thrive.
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 our financial guidance; our business strategy and goals; our expectations and projections about the company's future cash needs and financial results; our plans and expectations regarding our phase 3 trials in TRD, including our expectations regarding the time periods during which the results of the two Phase 3 trials will become available; the potential for the pivotal phase 3 program in TRD, any future trials in PTSD, or other trials to support regulatory filings and approvals; our expectations regarding the safety or efficacy of our investigational COMP360 psilocybin treatment, including as a treatment for treatment of TRD, PTSD, and anorexia nervosa; 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; the risk that our strategic collaborations will not continue or will not be successful; 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.
Condensed Consolidated Balance Sheets | |||||||
(unaudited) | |||||||
(in thousands, except share and per share amounts) | |||||||
(expressed in U.S. Dollars, unless otherwise stated) | |||||||
March 31, | December 31, | ||||||
2025 | 2024 | ||||||
ASSETS | |||||||
CURRENT ASSETS: | |||||||
Cash and cash equivalents | $ | 260,110 | $ | 165,081 | |||
Restricted cash | 379 | 389 | |||||
Prepaid expenses and other current assets | 44,979 | 35,821 | |||||
Total current assets | 305,468 | 201,291 | |||||
NON-CURRENT ASSETS: | |||||||
Operating lease right-of-use assets | 1,463 | 2,006 | |||||
Deferred tax assets | 4,028 | 3,774 | |||||
Long-term prepaid expenses and other assets | 8,176 | 6,595 | |||||
Total assets | $ | 319,135 | $ | 213,666 | |||
LIABILITIES AND SHAREHOLDERS' EQUITY | |||||||
CURRENT LIABILITIES: | |||||||
Accounts payable | $ | 8,584 | $ | 12,283 | |||
Accrued expenses and other liabilities | 11,194 | 14,495 | |||||
Debt, current portion | 8,988 | 5,513 | |||||
Operating lease liabilities - current | 1,233 | 1,725 | |||||
Total current liabilities | 29,999 | 34,016 | |||||
NON-CURRENT LIABILITIES | |||||||
Debt, non-current portion | 21,553 | 24,652 | |||||
Operating lease liabilities - non-current | 259 | 303 | |||||
Warrant liabilities | 71,857 | — | |||||
Total liabilities | $ | 123,668 | $ | 58,971 | |||
SHAREHOLDERS' EQUITY: | |||||||
Ordinary shares, £0.008 par value; 92,848,326 and 68,552,215 shares authorized, issued and outstanding at March 31, 2025 and December 31, 2024, respectively | 938 | 702 | |||||
Additional paid-in capital | 763,436 | 704,919 | |||||
Accumulated other comprehensive loss | (16,311 | ) | (16,194 | ) | |||
Accumulated deficit | (552,596 | ) | (534,732 | ) | |||
Total shareholders' equity | 195,467 | 154,695 | |||||
Total liabilities and shareholders' equity | $ | 319,135 | $ | 213,666 | |||
Condensed Consolidated Statements of Operations and Comprehensive Loss | |||||||
(unaudited) | |||||||
(in thousands, except share and per share amounts) | |||||||
(expressed in U.S. Dollars, unless otherwise stated) | |||||||
Three Months ended March 31, | |||||||
2025 | 2024 | ||||||
OPERATING EXPENSES: | |||||||
Research and development | $ | 30,880 | $ | 24,901 | |||
General and administrative | 18,736 | 13,672 | |||||
Total operating expenses | 49,616 | 38,573 | |||||
Loss from operations: | (49,616 | ) | (38,573 | ) | |||
OTHER INCOME (EXPENSE), NET: | |||||||
Fair value change of warrant liabilities | 19,460 | — | |||||
Benefit from R&D tax credit | 8,448 | 3,101 | |||||
Interest income | 2,386 | 2,260 | |||||
Foreign exchange gains (losses) | 2,133 | (783 | ) | ||||
Interest expense | (1,124 | ) | (1,098 | ) | |||
Other income | 803 | 128 | |||||
Total other income, net | 32,106 | 3,608 | |||||
Loss before income taxes | (17,510 | ) | (34,965 | ) | |||
Income tax expense | (354 | ) | (222 | ) | |||
Net loss | $ | (17,864 | ) | $ | (35,187 | ) | |
Net loss per share attributable to ordinary shareholders: basic | $ | (0.20 | ) | $ | (0.55 | ) | |
Weighted average ordinary shares outstanding: basic | 89,192,252 | 64,222,178 | |||||
Net loss per share attributable to ordinary shareholders: diluted | $ | (0.24 | ) | $ | (0.55 | ) | |
Weighted average ordinary shares outstanding: diluted | 98,641,624 | 64,222,178 | |||||
Net loss | $ | (17,864 | ) | $ | (35,187 | ) | |
Other comprehensive loss: | |||||||
Foreign exchange translation adjustment | (117 | ) | (36 | ) | |||
Comprehensive loss | $ | (17,981 | ) | $ | (35,223 | ) | |
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Enquiries Â
Media: Dana Sultan-Rothman, media@compasspathways.com , +1 484 432 0041
Investors: Stephen Schultz, stephen.schultz@compasspathways.com , +1 401 290 7324
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COMPASS Pathways Plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation announced today it is entering into a strategic collaboration with HealthPort, a multi-site comprehensive community health organization. HealthPort employs an integrated model centered around social determinants of health and this collaboration will help inform the potential delivery of COMP360 synthesized psilocybin treatment in underserved communities, if FDA approved. This agreement with HealthPort expands the set of collaborations that Compass has established representing a broad spectrum of settings where people living with treatment resistant depression (TRD) receive their care in the United States.
HealthPort offers an integrated model of care aimed at helping those with behavioral health conditions and people impacted by poverty, disability and trauma. HealthPort is an evidence-based practice supporting thirteen dimensions of social determinants of health, including the coordination of an integrated outpatient mental health and addictions health clinic. HealthPort has been operating facility, residential, and mobile based interventions of care in the lower Eastern Shore of Maryland for the past 45 years.
Together, Compass and HealthPort will learn about the challenges and barriers to equitable access to new mental health treatments and they will conduct research into training and care reimbursement processes for COMP360, if approved. The companies will explore how investigational COMP360 synthesized psilocybin treatment might fit into an integrated health delivery practice similar to HealthPort. This exploration is designed to provide a template for potential future implementation and delivery of COMP360 within community care settings across the US. COMP360 is a synthesized, proprietary formulation of psilocybin under investigation as a treatment for certain difficult-to-treat mental health conditions, including treatment resistant depression (TRD).
"We are proud to collaborate with Compass Pathways and to contribute to learning how COMP360 psilocybin treatment may be most effectively delivered to patients in underserved communities, if that treatment receives all necessary approvals for TRD," said Dimitrios Cavathas, CEO of HealthPort. "We are committed to addressing the social determinants of health that impact our community members and collaborating with Compass will help further our mission to serving the unique needs of our people."
"We strive to improve mental healthcare for every person who needs help, and we recognize the challenges to access for underserved populations and the potential for innovative treatments, such as COMP360, to lessen existing disparities, if approved," said Steve Levine, Chief Patient Officer of Compass Pathways. "We are thrilled to join forces with a leading integrated community health center, such as HealthPort, to further refine our understanding of how COMP360 psilocybin treatment could be delivered to patients in the future and, together, advance equitable access to mental healthcare."
About Compass Pathways' strategic collaborations
Compass is forming a comprehensive and diverse set of collaborations to inform how investigative COMP360 synthesized psilocybin treatment can be integrated into different types of healthcare delivery systems in the US.
Compass also has previously announced collaboration agreements with Greenbrook TMS, a leading provider of interventional psychiatric treatments such as Spravato and transcranial magnetic stimulation; Hackensack Meridian Health, a leading not-for-profit health care organization and the largest, most comprehensive and truly integrated network in New Jersey, addressing the full continuum of care for people living with TRD; Reliant Medical Group, an Optum company and integrated primary and specialty care organization; Journey Clinical, a leading psychedelic-assisted psychotherapy platform in the US; and Mindful Health Solutions, one of the US's leading providers of innovative behavioral health 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. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthesized psilocybin treatment, potentially a first in class treatment. 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. We envision a world where mental health means not just the absence of illness but the ability to thrive.
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", "should", "expect", "intend", "plan", "believe", "estimate", "predict", "possible", "potential" and "ongoing," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, the safety or efficacy of investigational COMP360 psilocybin treatment as a treatment for treatment-resistant depression, post-traumatic stress disorder or anorexia nervosa, the potential for the pivotal phase 3 program or other trials to support regulatory filings and approvals, Compass's business strategy and goals, Compass's plans, expectations and ability to achieve its goals related to this strategic collaboration agreement and its other collaborations; Compass's ability to continue to advance its research, obtain regulatory approval or develop plans to bring investigational COMP360 psilocybin treatment to patients, and Compass's expectations regarding the benefits of its 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: clinical development is lengthy and outcomes are uncertain, and therefore Compass's clinical trials may be delayed or terminated; the results early-stage clinical trials of investigational COMP360 psilocybin treatment may not be predictive of the results of later stage clinical trials; the possibility of unfavorable results from additional clinical trials of investigational COMP360 psilocybin treatment or from subsequent analysis of existing data or new data received from additional ongoing and future studies of investigational COMP360 psilocybin treatment; Compass's efforts to obtain marketing approval from the applicable regulatory authorities in any jurisdiction for investigational COMP360 or any of future product candidates may be unsuccessful; Compass's efforts to obtain coverage and reimbursement for its investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; the risk that this collaboration with HealthPort or one or more of our previously announced collaborations will not continue or will not achieve the expected benefits; uncertainties regarding the ability to develop a scalable and cost-effective delivery model for investigational COMP360 psilocybin treatment, if approved; the risk that market adoption and access to investigational COMP360 psilocybin treatment, if approved, may be limited 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 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.
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Enquiries Â
Media: Dana Sultan-Rothman, media@compasspathways.com , +1 484 432 0041
Investors: Stephen Schultz, stephen.schultz@compasspathways.com , +1 401 290 7324
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Compass management will host a conference call at 8:00 am ET (1:00 pm UK)
COMPASS Pathways Plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that it will release financial results for the first quarter ended March 31, 2025, and provide an update on recent developments, on May 8, 2025.
Compass management will host a conference call at 8:00 am ET (1:00 pm UK) on May 8, 2025.
A live webcast of the call will be available on the Compass Pathways website at: First Quarter 2025 Financial Results. The webcast will be archived for 30 days.
About Compass Pathways
COMPASS Pathways Plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthesized psilocybin treatment, potentially a first in class treatment. 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. We envision a world where mental health means not just the absence of illness but the ability to thrive.
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Enquiries Â
Media: Dana Sultan-Rothman, media@compasspathways.com , +1 484 432 0041
Investors: Stephen Schultz, stephen.schultz@compasspathways.com , +1 401 290 7324
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Highlights:
COMPASS Pathways Plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, today announced that all participants have completed dosing in Part A of the COMP005 phase 3 trial for treatment resistant depression (TRD). Following pre-dosing activities, including washout from anti-depressant medications, if needed, participants received a single dose of either 25 mg of COMP360 or placebo. The Company is on track to disclose top-line 6-week primary endpoint results in late June.
"Completing dosing of all participants in Part A of our 005 trial marks a critical milestone in our mission to address the pressing unmet need in treatment resistant depression," said Kabir Nath, CEO Compass Pathways. "We are proud of this achievement which reflects our team's commitment to scientific rigor, operational excellence and potential to deliver a new treatment option to patients who have long been underserved. We are incredibly grateful to the participants, investigators and clinical sites that are making this study possible. We look forward to sharing the results of the 6-week primary endpoint in late June."
About the phase 3 COMP005 trial
To date, the COMP005 trial is the largest, multi-center study of an investigational, synthesized psilocybin to complete recruitment and will be the first pivotal program to report the efficacy of synthesized psilocybin for the treatment of TRD. In this randomized, double-blinded, placebo-controlled study, 258 participants with moderate-to-severe depression that have not responded to at least two or more prior treatments were dosed across 32 sites in the United States. This study aims to assess the efficacy and safety of a single dose of COMP360 25 mg versus placebo for reducing symptom severity in TRD.
The trial is comprised of three parts: Part A, which is blinded through 6 weeks, Part B, which remains blinded through week 26, and Part C, which is open-label from week 26 to week 52.
COMP360 is a synthesized, proprietary formulation of psilocybin under investigation as a treatment for certain difficult-to-treat mental health conditions.
About treatment resistant depression (TRD)
Depression is one of the most common mental health disorders and the largest contributor to disability globally according to the World Health Organization. Approximately 300 million people , representing 5% of the adult population, suffer from major depressive disorder (MDD) worldwide.
Approximately one-third of patients with MDD aren't helped by existing therapies and are at high risk of developing treatment-resistant depression. TRD is generally defined as an inadequate response to two or more appropriate courses of approved medications. TRD has a significantly greater impact on individuals compared to MDD, leading to residual symptoms, poorer quality of life, increased comorbidities, higher mortality, and an increased risk of suicide.
About Compass Pathways
COMPASS Pathways Plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthesized psilocybin treatment, potentially a first in class treatment. 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. We envision a world where mental health means not just the absence of illness but the ability to thrive.
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 business strategy and goals; our plans and expectations regarding our phase 3 trials in TRD, including our expectations regarding the time periods during which the results of the two Phase 3 trials will become available; our expectations regarding the time periods during which results of other pivotal trials of synthesized psilocybin will become available; the potential for the pivotal phase 3 program in TRD, any future trials in PTSD, or other trials to support regulatory filings and approvals; our expectations regarding the safety or efficacy of our investigational COMP360 psilocybin treatment, including as a treatment for treatment of TRD; our ability to obtain regulatory approval and adequate coverage and reimbursement; and our ability to transition from a clinical-stage to a commercial-stage organization and effectively launch a commercial product, if regulatory approval is obtained. 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; 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, 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/20250422821349/en/
Enquiries
Media: Dana Sultan-Rothman, media@compasspathways.com , +1 484 432 0041
Investors: Stephen Schultz, stephen.schultz@compasspathways.com , +1 401 290 7324
News Provided by Business Wire via QuoteMedia
Highlights:
COMPASS Pathways Plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, today announced the completion of recruitment in the COMP005 phase 3 trial for treatment resistant depression (TRD). The final participants are completing pre-dosing activities, including washout from anti-depressant medications, if necessary, and those eligible will receive a dose of either 25 mg of COMP360 or placebo.
"We are pleased that recruitment is complete in the 005 trial, bringing us one-step closer to delivering COMP360 as a potential first-in-class psilocybin treatment for patients with treatment resistant depression," said Kabir Nath, Chief Executive Officer of Compass Pathways. "We await completion of dosing of the last participant, a milestone that we will also announce in the coming weeks, and we look forward to sharing the results of the 6-week primary endpoint in late Q2."
COMP360 is a synthetic form of psilocybin under investigation as a treatment for certain difficult-to-treat mental health conditions when administered with psychological support.
TRD is a condition in which individuals with major depressive disorder do not respond adequately to at least two different treatments. Depression is the leading cause of disability and ill health worldwide. Up to two-thirds of people with depression are not helped by the first antidepressant medication they try. Up to a third of people with depression are failed by multiple attempts at treatment.
The pivotal phase 3 clinical program of COMP360 psilocybin treatment in TRD is the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted. Top-line 6-week (primary endpoint) COMP005 data is expected late in the second quarter 2025 and 26-week COMP005 data is expected once all participants in the COMP006 trial have completed part A of the COMP006 trial. The COMP006 26-week data is expected in the second half of 2026.
About Compass Pathways
COMPASS Pathways Plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 psilocybin treatment, potentially a first in class treatment. 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 business strategy and goals; our plans and expectations regarding our phase 3 trials in TRD, including our expectations regarding the number of participants that will be dosed and the time periods during which the dosing of all participants will be completed and the results of the two Phase 3 trials will become available; the potential for the pivotal phase 3 program in TRD, any future trials in PTSD, or other trials to support regulatory filings and approvals; our expectations regarding the safety or efficacy of our investigational COMP360 psilocybin treatment, including as a treatment for treatment of TRD; our ability to obtain regulatory approval and adequate coverage and reimbursement; and our ability to transition from a clinical-stage to a commercial-stage organization and effectively launch a commercial product, if regulatory approval is obtained. 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; participants who have completed screening may not complete pre-dosing activities and enroll in our COMP005 trial; 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; 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, 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/20250326830443/en/
Enquiries Â
Media: Media, media@compasspathways.com
Investors: Stephen Schultz, stephen.schultz@compasspathways.com , +1 401 290 7324
News Provided by Business Wire via QuoteMedia
Highlights:
COMPASS Pathways Plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, today announced the publication of results from the COMP004 study, an observational 52-week follow-up from the Phase 2 COMP001 and COMP003 trials of COMP360 psilocybin treatment in patients with treatment-resistant depression (TRD). The COMP004 study's findings suggest that over a 52-week period, a single administration of 25 mg COMP360 psilocybin demonstrated a longer maintenance of antidepressant effects compared to the 1 mg and 10 mg doses.
The results of COMP004 build upon previous findings from the Phase 2b trial COMP001, which showed that a single 25mg dose of COMP360 psilocybin was associated with a rapid and highly statistically significant reduction in depressive symptoms compared to COMP360 1mg dose after three weeks (p
Key COMP004 findings
These COMP004 study data were published in the March edition of the Journal of Clinical Psychiatry.
COMP360 is a synthetic form of psilocybin under investigation as a treatment for certain difficult-to-treat mental health conditions when administered with psychological support.
"Treatment-resistant depression is a major public health challenge, affecting approximately 100 million people worldwide, and it is well understood that there is an urgent need for differentiated treatment options," said Dr. Guy Goodwin, Chief Medical Officer. "This study together with the Phase 2b (COMP001) suggest the potential of COMP360 to provide rapid and durable clinical benefits from a single administration. We continue to explore the full profile of COMP360 in our ongoing Phase 3 clinical development program and we look forward to seeing the first phase 3 data from our COMP005 trial in the second quarter."
TRD is a condition in which individuals with major depressive disorder do not respond adequately to at least two different treatments. Depression is the leading cause of disability and ill health worldwide. Up to two-thirds of people with depression are not helped by the first antidepressant medication they try. Up to a third of people with depression are failed by multiple attempts at treatment.
The pivotal phase 3 clinical program of COMP360 psilocybin treatment in TRD is the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted. Top-line 6-week (primary endpoint) COMP005 data is expected in the second quarter 2025 and 26-week COMP005 data is expected once all participants in the COMP006 trial have completed part A of the COMP006 trial. The COMP006 26-week data is expected in the second half of 2026.
About the COMP004 Trial
The COMP004 trial is a 52-week observational follow-up study on sixty-six participants from COMP001 (n=58 of which 22 participants were in the 25 mg arm, 19 participants were in the 10 mg arm and 17 participants were in the 1 mg arm) and COMP003 (n=8) trials to explore the long-term efficacy and safety of the three different doses of psilocybin (1 mg, 10 mg, and 25 mg) administered to patients with TRD as a monotherapy in COMP001 and 25 mg psilocybin administered as an adjunct to an SSRI in COMP003. Following completion of COMP001 or COMP003, as applicable, study participants had the option to enroll in COMP004 and there was a low rate of enrollment into COMP004. The analyses based solely on participants who enrolled in COMP004 are limited by the resulting selection bias.
About Compass Pathways
COMPASS Pathways Plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 psilocybin treatment, potentially a first in class treatment. 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 business strategy and goals; our plans and expectations regarding our phase 3 trials in TRD, including our expectations regarding the time periods during which the results of the two Phase 3 trials will become available; the potential for the pivotal phase 3 program in TRD, any future trials in PTSD, or other trials to support regulatory filings and approvals; our expectations regarding the safety or efficacy of our investigational COMP360 psilocybin treatment, including as a treatment for treatment of TRD; our ability to obtain regulatory approval and adequate coverage and reimbursement; and our ability to transition from a clinical-stage to a commercial-stage organization and effectively launch a commercial product, if regulatory approval is obtained. 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, including that the results from this long-term follow-up study may not be predictive of the results for our phase 3 program in TRD; 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; 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, 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/20250318973265/en/
Enquiries Â
Media: Media, media@compasspathways.com
Investors: Stephen Schultz, stephen.schultz@compasspathways.com , +1 401 290 7324
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