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.
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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
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Compass Pathways plc (Nasdaq: CMPS) ("Compass"), a biotechnology company dedicated to accelerating access to evidence-based innovation in mental health, today reported its financial results for the third quarter 2024 and an update on recent business progress.
"Ensuring the success of our lead COMP360 program is our absolute priority. We remain confident that COMP360 can be an effective therapy for patients with serious mental illness and our focus on delivering new treatment options for patients living with treatment-resistant depression remains paramount," said Kabir Nath, Chief Executive Officer of Compass Pathways. "The shift in the phase 3 pivotal program timeline has forced us to look carefully at our operations and ensure that every resource is focused on this goal. As such, we have made the difficult decision to reduce our workforce and exit activities that are not directly tied to the completion of the trials, regulatory filing and commercialization if approved. These are necessary strategic decisions that we believe will position the COMP360 program for success."
Business highlights
COMP360 psilocybin treatment in TRD
The 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 pivotal COMP005 trial data is expected in the second quarter 2025. In addition, as a result of the increased regulatory scrutiny on functional unblinding, the company has decided to shift the data release for COMP006 until after the 26-week time point and the completion of the blinded portion has been reached for all patients to protect against the risk of unblinding. With this change, Compass now expects data for COMP006 in the second half of 2026.
Prioritization of resources
As a result of changing timelines for the phase 3 trials, we will be reducing our workforce by approximately 30%, including eliminating some senior management positions, to further focus the organization and its capital resources on successfully delivering the COMP360 program. Our non-COMP360 preclinical efforts will be stopped and we are exploring a potential externalization for our digital health tools.
Financial highlights
Financial Guidance
Fourth quarter 2024 net cash used in operating activities is expected to be in the range of $37 million to $43 million. The full-year 2024 net cash used in operating activities is expected to be in the range of $114 million to $120 million. The cash position at September 30, 2024, is expected to be sufficient to fund operating expenses and capital expenditure requirements at least into 2026.
Conference call
The management team will host a conference call at 8:00 am ET (12:00 pm UK) on October 31, 2024. A live webcast of the call will be available on the Compass Pathways website at Third Quarter 2024 Financial Results. The webcast will also be on the Investors section of the Compass Pathways website 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. 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.
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", "will", "could", "would", "expect", "intend", "plan", "anticipate", "believe", "potential" and "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, our financial guidance; our business strategy and goals, our expectations and projections about the company's future cash needs and financial results; our plans for a strategic reorganization, including a reduction in workforce, and our expectations regarding impact and cost savings from our planned reduction in workforce; 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 expectations regarding the benefits of our investigational COMP360 psilocybin treatment; and our plans, expectations and ability to achieve our goals related to the research collaboration agreements. 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 our 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: we will require substantial additional funding to achieve our business goals, including to repay the term loan facility, 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 research and development efforts; the availability of future tranches under the term loan facility is dependent, in part, on the approval of the lender, achievement of certain milestones and other factors; clinical development is lengthy and outcomes are uncertain, and therefore our phase 3 clinical trials in TRD and our other clinical trials may be delayed or terminated; 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 efforts to obtain marketing approval from the applicable regulatory authorities in any jurisdiction for COMP360 or any of future product candidates may be unsuccessful; the risk that our research collaborations will not continue or will not be successful; and our efforts to 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 our 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 . Except as required by law, we disclaim 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 our current expectations and speak only as of the date hereof.
COMPASS PATHWAYS PLC Condensed Consolidated Balance Sheets (unaudited) (in thousands, except share and per share amounts) (expressed in U.S. Dollars, unless otherwise stated) | |||||||
September 30, | December 31, | ||||||
2024 | 2023 | ||||||
ASSETS | |||||||
CURRENT ASSETS: | |||||||
Cash and cash equivalents | $ | 206,953 | $ | 220,198 | |||
Restricted cash | 389 | 440 | |||||
Prepaid expenses and other current assets | 26,319 | 40,658 | |||||
Total current assets | 233,661 | 261,296 | |||||
NON-CURRENT ASSETS: | |||||||
Operating lease right-of-use assets | 2,745 | 4,306 | |||||
Deferred tax assets | 4,414 | 3,336 | |||||
Long-term prepaid expenses and other assets | 6,518 | 7,049 | |||||
Total assets | $ | 247,338 | $ | 275,987 | |||
LIABILITIES AND SHAREHOLDERS' EQUITY | |||||||
CURRENT LIABILITIES: | |||||||
Accounts payable | $ | 8,233 | $ | 5,892 | |||
Accrued expenses and other liabilities | 13,522 | 11,301 | |||||
Debt, current portion | 2,156 | — | |||||
Operating lease liabilities - current | 2,300 | 2,411 | |||||
Total current liabilities | 26,211 | 19,604 | |||||
NON-CURRENT LIABILITIES | |||||||
Debt, non-current portion | 27,638 | 28,757 | |||||
Operating lease liabilities - non-current | 459 | 1,882 | |||||
Total liabilities | $ | 54,308 | $ | 50,243 | |||
SHAREHOLDERS' EQUITY: | |||||||
Ordinary shares, £0.008 par value; 68,409,068 and 61,943,471 shares authorized, issued and outstanding at September 30, 2024 and December 31, 2023, respectively | 699 | 635 | |||||
Additional paid-in capital | 700,273 | 621,645 | |||||
Accumulated other comprehensive loss | (16,542 | ) | (16,926 | ) | |||
Accumulated deficit | (491,400 | ) | (379,610 | ) | |||
Total shareholders' equity | 193,030 | 225,744 | |||||
Total liabilities and shareholders' equity | $ | 247,338 | $ | 275,987 | |||
COMPASS PATHWAYS PLC 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 September 30, | Nine Months ended September 30, | ||||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||||
OPERATING EXPENSES: | |||||||||||||||
Research and development | $ | 32,928 | $ | 21,526 | $ | 86,898 | $ | 60,379 | |||||||
General and administrative | 14,968 | 12,536 | 42,893 | 38,135 | |||||||||||
Total operating expenses | 47,896 | 34,062 | 129,791 | 98,514 | |||||||||||
Loss from operations: | (47,896 | ) | (34,062 | ) | (129,791 | ) | (98,514 | ) | |||||||
OTHER INCOME (EXPENSE), NET: | |||||||||||||||
Benefit from R&D tax credit | 4,084 | 2,685 | 10,894 | 9,521 | |||||||||||
Interest income | 1,977 | 1,015 | 6,645 | 2,357 | |||||||||||
Interest expense | (1,137 | ) | (1,080 | ) | (3,347 | ) | (1,080 | ) | |||||||
Foreign exchange gains (losses) | 4,452 | (1,997 | ) | 3,894 | 2,064 | ||||||||||
Other income | 191 | 112 | 486 | 106 | |||||||||||
Total other income, net | 9,567 | 735 | 18,572 | 12,968 | |||||||||||
Loss before income taxes | (38,329 | ) | (33,327 | ) | (111,219 | ) | (85,546 | ) | |||||||
Income tax expense | (173 | ) | (62 | ) | (571 | ) | (386 | ) | |||||||
Net loss | $ | (38,502 | ) | $ | (33,389 | ) | $ | (111,790 | ) | $ | (85,932 | ) | |||
Net loss per share attributable to ordinary shareholders—basic and diluted | $ | (0.56 | ) | $ | (0.67 | ) | $ | (1.67 | ) | $ | (1.81 | ) | |||
Weighted average ordinary shares outstanding—basic and diluted | 68,395,343 | 49,633,104 | 67,001,326 | 47,355,992 | |||||||||||
Net loss | $ | (38,502 | ) | $ | (33,389 | ) | $ | (111,790 | ) | $ | (85,932 | ) | |||
Other comprehensive gain (loss): | |||||||||||||||
Foreign exchange translation adjustment | 339 | (738 | ) | 384 | (599 | ) | |||||||||
Comprehensive loss | $ | (38,163 | ) | $ | (34,127 | ) | $ | (111,406 | ) | $ | (86,531 | ) | |||
View source version on businesswire.com: https://www.businesswire.com/news/home/20241031740397/en/
Enquiries
Media: Sally Bain, sally.bain@compasspathways.com , + 1 781 458 0443
Investors: Stephen Schultz, stephen.schultz@compasspathways.com , +1 401 290 7324
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Seelos Therapeutics, Inc. (OTCQB: SEEL) ("Seelos"), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced that its 2024 Annual Meeting of Stockholders (the "Annual Meeting"), which was previously postponed to Friday, October 25, 2024 from its originally scheduled date of Friday, September 27, 2024 has been further postponed. The Annual Meeting is now scheduled to be held virtually, via live webcast at www.virtualshareholdermeeting.comSEEL2024 on Monday, November 25, 2024 at 8:00 a.m., Eastern Time . The record date for the Annual Meeting, August 19, 2024 is unchanged and applies to the postponed Annual Meeting.
The Annual Meeting has been postponed due to an anticipated lack of quorum, and to provide further time to solicit proxies from the Company's stockholders. Seelos' Board of Directors unanimously recommends that you vote FOR the Board of Director nominees and FOR all other proposals identified in the Company's proxy statement for the Annual Meeting. Stockholders who have already cast their votes do not need to take any action, unless they wish to change or revoke their prior proxy or voting instructions, and their votes will be counted at the postponed Annual Meeting. For stockholders who have not yet cast their votes, we urge them to vote their shares now, so they can be tabulated prior to the postponed Annual Meeting.
About Seelos Therapeutics
Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare diseases.
For more information, please visit our website: https://seelostherapeutics.com , the content of which is not incorporated herein by reference.
IMPORTANT ADDITIONAL INFORMATION
Seelos has filed a definitive proxy statement with the Securities and Exchange Commission (the "SEC") on August 20, 2024 . STOCKHOLDERS ARE URGED TO READ THE PROXY STATEMENT (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) FILED BY SEELOS AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT ANY SOLICITATION. Stockholders may obtain a free copy of the proxy statement and the other relevant materials, and any other documents filed by Seelos with the SEC, at the SEC's web site at http://www.sec.gov or on the "SEC Filings" section of Seelos' website at https://seelostherapeutics.com .
Participants in the Solicitation
Seelos, its directors and executive officers and other members of management and employees will be participants in the solicitation of proxies with respect to a solicitation by Seelos. Information about Seelos' executive officers and directors, including information regarding the direct or indirect interests, by security holdings or otherwise, is available in Seelos' definitive proxy statement for its Annual Meeting, which was filed with the SEC on August 20, 2024 . To the extent holdings by our directors and executive officers of Seelos securities reported in the proxy statement for the Annual Meeting have changed, such changes have been or will be reflected on Statements of Change in Ownership on Forms 3, 4 or 5 filed with the SEC. These documents are or will be available free of charge at the SEC's website at http://www.sec.gov .
Forward-Looking Statements
Statements made in this press release, which are not historical in nature, constitute forward-looking statements related to Seelos for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements are based on Seelos' current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos' business and plans described herein include, but are not limited to, the risk of not receiving stockholder approval of any of the proposals to be presented at the Annual Meeting, the risks related to raising capital to fund its development plans and ongoing operations and risks related to Seelos' current stock price, as well as other risk factors and matters set forth in our periodic filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2023 , subsequent Quarterly Reports on Form 10-Q, including Seelos' Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 . Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
Contact Information:
Mike Moyer
Managing Director
LifeSci Advisors, LLC
250 West 55th St., Suite 3401
New York , NY 10019
(617) 308-4306
mmoyer@lifesciadvisors.com
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SOURCE Seelos Therapeutics, Inc.
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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 third quarter 2024 ending September 30, 2024, and provide an update on recent business developments, on October 31, 2024.
The management team will host a conference call at 8:00 am ET (12:00 pm UK) on October 31, 2024. To access the call, please register in advance here to obtain a local or toll-free phone number and your personal pin.
A live webcast of the call will be available on the Compass Pathways website at: Third Quarter 2024 Financial Results
The webcast will also be available on the Investors section of the Compass Pathways website. The webcast will be archived for 30 days.
About Compass Pathways
Compass Pathways plc (Nasdaq: CMPS) is a 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/20241024060255/en/
Enquiries
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
