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.
News Provided by ACCESSWIRE via QuoteMedia
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
Partnered with SRx Health Solutions and BioScript Solutions to Build Out a Network of NeonMind-branded Specialty Mental Health Clinics Across Canada
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 plans to launch 10 specialty mental health clinics over the next 3 years through alliances with SRx Health Solutions and BioScript Solutions, leading Canadian specialty healthcare services and medical treatment providers
Approximately 1 in 10 Canadians use health services annually for mood and anxiety disorders, according to a Canadian government report, Mood and Anxiety Disorders in Canada. Major health care institutions are acknowledging the increasing burden of the crisis and the need to provide support access to treatments, including Ontario Health's Roadmap to Wellness which will invest $3.8 billion into mental health; Veterans Affairs Canada is launching new mental health benefits and insurance companies are providing coverage to new mental health treatments.
New, effective treatments for mood and anxiety disorders have been developed with proven benefits to patients, including intravenous ketamine (IV-Ket) and neurostimulation. These treatments require short visits to a clinic typically lasting 2 hours or less. NeonMind's research reveals there is a lack of available and conveniently located clinics providing these treatments. NeonMind's Specialty Mental Health Clinics division is executing on its strategy to increase availability of these treatments by building out clinic locations with our trusted partners that are leading providers of specialty medical treatments with a network of hundreds of established clinic locations.
"By partnering with SRx Health Solutions and BioScript, we can leverage their established clinic network and operational excellence in specialty medical treatments to introduce our mental health treatments in an expedient and capital efficient manner and importantly, working with an infrastructure that enables scaling" said Rob Tessarolo, President & CEO of NeonMind Biosciences. "With very little upfront costs for each location, we expect to be able to open NeonMind clinics in at least 10 new communities over the next few years and are pleased to offer this referral service to medical doctors and their patients who recognize the benefits of IV-Ket and neurostimulation but are not set up to deliver the treatments in their own clinics."
NeonMind plans to launch its first treatment location this summer in Mississauga, Ontario in 2022. Its innovative business model allows it to launch each location with substantial savings in launch costs by launching within an existing clinic location. The alliances mean NeonMind can avoid high leasehold improvements and overhead and is able to share costs on medical staffing.
Initially NeonMind clinics will offer IV-Ket, a validated treatment that was recently added to the Canadian guidelines. IV-Ket requires a licensed clinic setup and a team of specially trained healthcare professionals which most medical clinics cannot achieve and therefore are not able to provide this treatment. NeonMind is closing the treatment gap by offering medical doctors a trusted referral partner for their patients to get access to IV-Ket.
NeonMind's inaugural specialty mental health clinic will be 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.
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
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“Participants and analysts have known that the psychedelic opportunity is ultimately a long game that requires public policy progression alongside pharmaceutical advancement and innovation. Ultimately, a watershed moment could lead to a waterfall effect across the industry."
— Naseem Husain, Horizons ETFs
"I see the US Food and Drug Administration approving one or both of these compounds (psilocybin and MDMA) and a new medical model and industry will be birthed in 2024 and 2025."
— Andrew DeAngelo, Forbes
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Psychedelics Market 2023 Year-End Review
Psychedelics Market Forecast: Top Trends That Will Affect Psychedelics in 2024
The psychedelics industry is maturing after the investment boom of 2020 and 2021, and patient long-term investors looking for opportunities to diversify their portfolios have options when it comes to exposure.
As clinical trials and research continue to demonstrate the potential benefits of psychedelic-assisted therapy (PAT), companies in the space are attracting more attention. The Investing News Network (INN) spoke with Naseem Husain, senior vice president and exchange-traded fund (ETF) strategist at Horizons ETFs, to get his thoughts on 2023.
"Compared to the market fervor in 2020/2021, like (2022), 2023 was a quieter and colder year in the psychedelics marketplace. This past year, no major catalysts emerged and there was continued consolidation in the industry — a trend that will likely continue," the expert said during the interview, emphasizing the period's slowness.
"That being said, clinical trials take time, and participants and analysts have known that the psychedelic opportunity is ultimately a long game that requires public policy progression, alongside pharmaceutical advancement and innovation. Ultimately, a watershed moment could lead to a waterfall effect across the industry," Husain added.
According to Research Nester, the psychedelic drug market was worth US$3 billion in 2022. If it grows at the firm's estimated compound annual growth rate of 14 percent, the market will be worth more than US$12 billion by 2035.
“There are 22 million American adults suffering from depression, 300 million people worldwide. So unfortunately, there's a very large unmet need and a massive market opportunity,” Cybin (NYSEAMERICAN:CYBN) CEO Doug Drysdale explained in an end-of-year conversation with INN. “The (depression and anxiety) market is maybe around a US$40 billion potential. If you add in other potential indications … like postpartum depression, alcohol use disorder or eating disorders, you're looking at a total addressable market of maybe US$100 billion annually.”
Here INN looks back on the psychedelics space in 2023 and highlights key developments and trends.
As more people struggle with mental health and the addiction crisis worsens, a growing body of evidence suggests that psychedelic substances may offer much-needed relief. Researchers have continued to demonstrate that these treatments can be used to treat a variety of mental health disorders, and may reduce healthcare costs as well.
This has sparked a shift in the US legislative landscape, with increasing bipartisan support for psychedelic drug reform. At the federal level, President Joe Biden has expressed his expectation that psychedelic therapies will be approved in specific circumstances, and in 2023, the Food and Drug Administration (FDA) took steps to facilitate the development of psychedelic therapies when it released a comprehensive guide for clinical investigations.
At the state level, Oregon and Colorado have emerged as pioneers in the regulated use of psychedelics, with Oregon granting its first license for a healing center in March after officially legalizing PAT in January. Likewise, Colorado passed its Regulated Natural Medicine and Legalization Act in July, and will progressively implement various PATs.
While some states have introduced legislation to legalize or decriminalize psychedelics, the legislative process can be slow and outcomes uncertain. For example, while Oklahoma has approved HB 3414 to increase research, other legislation is still working its way through the system, such as New York's Psychedelic Law Enforcement Reform Act.
In October, California Governor Gavin Newsom signed a bill to immediately allow doctors to prescribe psychedelic treatments if the substances are rescheduled. However, he vetoed SB 58, which sought to decriminalize the possession and personal use of a selected group of psychedelics, after it had already passed through the Senate and Assembly. Newsom said his reason for vetoing the bill was that it failed to meet guidelines that would criminalize possession outside of medical clearance. It also didn’t satisfy the criteria for treatment guidelines, such as dose information.
Outside the US, other countries have also been taking steps to regulate and explore the therapeutic potential of psychedelics. Canada, the US' northern neighbor, is one example — on a provincial level, Alberta enacted a new policy at the start of 2023 that regulates psychedelic drugs for mental health treatment.
Federally, most psychedelic therapies remain illegal. However, Canadians continue to lobby for increased access to these treatments, and in rare cases can be approved for PATs that are undergoing clinical trials through the country’s Special Access Program. Last year, the Senate’s Subcommittee on Veteran Affairs published a report calling on governments at all levels to perform a large-scale research program on PATs, as the treatments have the potential to greatly help military veterans, an underserved demographic for which mental health struggles are common.
One company making this a focus is the veteran-founded Apex Labs, whose psilocybin product APEX-90 was recently approved for a 160 macro-dose clinical trial starting in the first quarter of 2024. However, ahead of the trial, a Canadian military veteran with treatment-resistant depression was approved for the treatment through the Special Access Program; they received a dose on November 2 in Vancouver accompanied by psychotherapy.
For its part, Australia has taken a different approach. On July 1, legalization took effect for MDMA and psilocybin for the medical treatment of post-traumatic stress disorder (PTSD) and depression, respectively, in tandem with therapy.
“Time will tell, but the Australian announcement is likely the biggest ‘positive’ event for the space and could provide a model for other jurisdictions to emulate,” Husain said. “If a major country like Australia is able to successfully administer psychedelic medicines, that could prove a catalyst for Canada and other Commonwealth nations.”
The use of psychedelics for therapeutic purposes continued building momentum in 2023 as clinical trials investigating the efficacy of these substances for treating a range of mental health conditions reached new milestones.
One of the more notable trials of 2023 was Compass Pathways' (NASDAQ:CMPS) investigation of the effectiveness of its product, COMP360, in treating bipolar II depression. This was the first study of PAT on bipolar disorder. The results, which were published in JAMA Psychiatry on December 6, suggest that psilocybin combined with psychotherapy could be an effective and safe treatment for bipolar II depression. The company is also studying the use of COMP360 to treat mental health disorders such as anorexia, PTSD and treatment-resistant depression, among others.
Another significant development in the field of psychedelic therapies was the publication of positive results from MindMed’s (NASDAQ:MNMD,NEO:MMED) Phase 2b trial of its LSD-based product MM-120, which was being investigated as a potential treatment for generalized anxiety disorder. According to the company’s website, there is also evidence to suggest that MM-120 could be effective for treating chronic pain and substance use disorders. MindMed’s share price rose by 7 percent following the news. The company plans to move on to Phase 3 trials in 2024.
Cybin, another player in the psychedelics industry, reported positive topline data from Phase 2 clinical trials of CYB003 for major depressive disorder. “(It’s) really unprecedented to see 80 percent of patients in remission after two doses. I don't think we've ever seen anything like that in depression, ever,” Cybin’s Drysdale commented to INN about the results. The US Patent and Trademark Office granted the company a patent for its product on December 6.
Finally, MAPS Public Benefit, a subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), submitted a new drug application to the FDA in December following positive results from Phase 3 trials that studied the efficacy of its MDMA-assisted therapy for treating PTSD. On January 5, MAPS Public Benefit announced it was changing its name to Lykos Therapeutics as it begins to focus on product commercialization pending FDA approval of its treatment.
The market for psychedelic therapies is evolving, and with the changing landscape there will be challenges that must be addressed. In a December 2022 research paper, experts explored the economic considerations surrounding PAT, including market dynamics and the potential for growth and consolidation in the space.
Bruce Campbell, president and portfolio manager at StoneCastle Investment Management, discussed MindMed in a market call with BNN Bloomberg: “One of the risks they obviously have with a company like (MindMed), they're going to need to continually raise money over time, much like the cannabis sector has done, to kind of build out their operations. So they're nowhere near the point where they're going to be cashflow positive. So you do have to be aware that if the stock runs up it could pull back on financing, and it's probably a position that you want to trade around.”
Campbell’s comments specifically address MindMed, but they also speak to the broader challenges and risks associated with investing in the psychedelics industry, including the need for ongoing funding and the potential volatility.
While some clinical trials have yielded promising results, companies must still overcome the complexities of patenting and commercializing their products. One issue that could hinder profitability is that psychedelic compounds are naturally occurring substances that may be difficult to protect under existing intellectual property laws.
To address this challenge, companies in the psychedelics industry are exploring a range of strategies, including developing novel formulations of compounds, combining them with other ingredients to create proprietary products and leveraging their expertise and data to establish a competitive advantage.
For example, Numinus Wellness (TSX:NUMI,OTCQX:NUMIF) made significant changes to its business in 2023 in order to increase its revenue, including launching a clinic licensing platform called Numinus Network, expanding its practitioner training programs and partnering with Healing Commercial Real Estate to find more clinics for its services. The company also closed operations at its non-revenue-producing Numinus Bioscience research lab.
After turning its focus to revenue-generating activities, Numinus reported significant growth in revenue in the fourth quarter of 2023, including US$5 million from the company’s wellness clinics.
As part of its focus on practitioner training, Numinus announced a partnership with MAPS in June, for which it submitted a clinical trial application to Health Canada. The purpose of the trial is to study how healthcare practitioners could establish protocols and procedures for MAPS’ MDMA-assisted therapy and identify any potential challenges. If successful, Numinus has plans to incorporate the therapy into its repertoire of PAT education and training programs.
While regulatory considerations are an important factor in the growth and development of the PAT industry, another trend affecting the sector is the increasing consolidation of the market through mergers and acquisitions.
“We've seen a huge amount of consolidation over the last couple of years, down from maybe 60 reported psychedelic companies to frankly only about a half a dozen now that are really focused on drug development,” Drysdale noted. Two such examples in 2023 were Cybin’s acquisition of Small Pharma and Otsuka’s (TSE:4578) acquisition of Mindset.
As the PAT sector develops, concerns are also arising, especially when it comes to the need for companies to balance affordable and equitable access to treatment as they pursue growth and expansion.
To this end, Beckley Waves, a venture studio that works exclusively with practitioners in the psychedelics space, established the New Ethics Council in June. The council is composed of experts who will be able to provide guidance on best practices. Among them is Beckley Waves founder Amanda Fielding, who has been an influential presence in the industry for generations, pouring over 55 years of research into the benefits of psychedelic experiences.
Looking back on recent developments in the psychedelics industry, it’s clear that in 2023 the field made significant strides in terms of clinical research, as well as some regulatory progress.
Of course, uncertainties still lie ahead in this young sector. “Despite positive broader market performance across other major indices, risk-off sentiment from 2022 persisted throughout 2023, which has led to a greater gulf between the psychedelic and biotech industries and other sectors,” said Husain.
Don’t forget to follow us @INN_LifeScience for real-time news updates!
Securities Disclosure: I, Meagen Seatter, hold no direct investment interest in any company mentioned in this article.
Editorial Disclosure: The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.
Additional information on investing in psychedelics stocks — FREE
As research into psychedelic drugs continues to produce positive results, policymakers are taking note.
With promising clinical trials, increasing public acceptance and a growing desire for psychedelic-assisted therapies (PATs), the sector seems to be poised for significant growth in the coming years.
Heading into 2024, the Investing News Network (INN) turned to industry insiders to dig into what might be in store for the psychedelics market. Read on to learn what they had to say.
Psychedelics companies are seeing a growing influx of funding and support thanks to positive clinical trial results.
“I think we've seen a shift in the last maybe three or four months of the year where more institutions are starting to look back at the psychedelic space again,” Cybin (NYSEAMERICAN:CYBN) CEO Doug Drysdale said in an interview with INN. “We had Steven Cohen's fund, Point72, make a significant investment in Cybin. They came in on our (at-the-market offering), and a number of other institutions are paying attention now as the sector is maturing.”
In addition, Lykos Therapeutics, which just changed its name from MAPS Public Benefit, secured US$100 million in Series A funding from a group of private investors in January 2024.
Lykos was previously focused on developing PATs for a range of mental health disorders, but after completing Phase III trials for its MDMA-assisted therapy for post-traumatic stress disorder in 2023, and then submitting a new drug application (NDA) to the US Food and Drugs Administration (FDA) in December, the company has changed its focus to bringing its MDMA treatment to market. The funding will be used to support these ongoing efforts.
Several of the same investors also recently contributed to a US$3.3 million funding round for Beckley Waves, a venture studio formed exclusively for the development of the psychedelics industry.
The regulatory landscape for these psychedelic substances will play a crucial role in shaping the market, with drug reform and decriminalization efforts having the potential to unlock significant growth opportunities.
While the current legislative landscape for psychedelics bears some similarities to that of the cannabis industry, there are also key differences, namely psychedelics companies' sole focus on therapeutic applications.
“In my opinion, the psychedelics industry is completely different than the cannabis market,” said Naseem Husain, senior vice president and exchange-traded fund (ETF) strategist at Horizons ETFs. “One is a medical and biotechnology opportunity, while another is primarily focused on retail, at least in the North American market. While both have legal barriers to overcome that could result in growth, the psychedelic pipeline is about pharmaceutical and regulatory development and less so about marketing and distribution like we’ve seen in the hyper-competitive cannabis sector.”
This crucial distinction could create greater accessibility for the patients who need these treatments. More and more practitioners are being allowed to administer psychedelic drugs via trials, and certain US states and Canadian provinces have legalized PATs or developed regulatory mechanisms to make them accessible, such as Health Canada’s Special Access Program. Even Australia, a country that has maintained a strict stance on cannabis, has approved the legal therapeutic use of MDMA and psilocybin, although some scientists have called the decision rushed.
In some cases, patients are circumventing federal roadblocks either by procuring illicit substances on their own, or by seeking treatment through private institutions. For example, psychedelic integration therapy, which helps individuals process and integrate insights gained during a psychedelic experience, is available in Vancouver, BC, but often at an exorbitant cost, and patients are left to source psychedelic compounds on their own.
What Drysdale and other market participants hope to achieve through their therapies is affordable and effective treatment, which needs Health Canada or FDA approval to be accessible.
“What we're doing is we are creating and producing synthetic, modified molecules, GMP manufactured, hoping to be FDA approved, prescribed by a doctor, reimbursed by your insurance company,” he said. “And I think that's what you need to attract the attention of patients who are already depressed and dealing with stuff. I think that some may go seek natural mushrooms, but if we can make these treatments really accessible through this regulated route first, then I think that's the most reliable and less risky way of providing really significant access.”
Could 2024 be the year for psychedelic drug reform? Some experts think the answer could be yes.
“I see the FDA approving one or both of these compounds (psilocybin and MDMA) and a new medical model and industry will be birthed in 2024 and 2025,” Andrew DeAngelo said in a Forbes article on cannabis and psychedelics market predictions for 2024. However, he also acknowledged that the industry is often unpredictable.
That said, there has been some progress on that front.
As mentioned, Lykos has now submitted an NDA to the FDA for its MDMA treatment, and the company requested a priority review because of the FDA’s designation of MDMA as a breakthrough therapy. If the FDA accepts the application, the process will take six months with a priority review or 10 months with a regular review.
If the FDA ultimately approves the treatment, MDMA would need to be moved from Schedule I to Schedule II, opening the door for other practitioners who have potential therapies in their pipelines.
While legalization is widely expected in the future, opinions vary on how quickly it will come. For instance, the American Medical Association predicts that most states will have legalized psychedelics by 2037 — that means current investors might still need to wait a while before they start seeing high returns on investment.
“Participants and analysts have known that the psychedelic opportunity is ultimately a long game that requires public policy progression alongside pharmaceutical advancement and innovation. Ultimately, a watershed moment could lead to a waterfall effect across the industry,” Husain said.
The evidence suggests that the psychedelics industry could be on the brink of significant growth in the coming years, but with some caveats. While clinical trial results have been promising and public acceptance is growing, the regulatory landscape will play a critical role in shaping the future of the market.
With the right regulations and approvals in place, psychedelics could revolutionize mental health treatments by offering affordable and effective therapies to those who need them.
Don’t forget to follow us @INN_LifeScience for real-time news updates!
Securities Disclosure: I, Meagen Seatter, hold no direct investment interest in any company mentioned in this article.
Editorial Disclosure: The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.
Additional information on investing in psychedelics stocks — FREE
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 23 rd Annual Needham Virtual Healthcare Conference at 8:00am ET on April 9, 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 such event. For more information, please visit investor section of compasspathways.com.
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 suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the U.S. 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 COMP 360 psilocybin therapy in TRD, the largest randomized, controlled, double-blind psilocybin therapy clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing a statistically significant (p www.compasspathways.com .
Availability of other information about Compass Pathways
Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including, but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
Enquiries
Media: Amy Lawrence, amy@compasspathways.com , +44 7813 777 919
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 patient access to evidence-based innovation in mental health, today announced that Board Chair and co-founder George Goldsmith and fellow co-founder Ekaterina Malievskaia have resigned their seats on the company's board of directors, effective March 29, 2024.
David Norton, lead independent director on the Compass board of directors, will become interim chair. Compass is running a global search for a permanent board chair, focused on recruiting a leader with a strong background in the biotechnology sector and broad strategic experience across the product lifecycle.
"When we started Compass eight years ago, we could not have imagined how the company would grow and mature," said George Goldsmith, outgoing board chair of Compass Pathways. "The company is on a strong, positive trajectory to develop psilocybin treatment under Kabir Nath's principled leadership. My commitment to transforming mental health care is unwavering. It is time to turn my attention to the next phase of making this vision a reality for patients, providers and health systems independent of any particular treatment modality."
"Everyone has a story, and too often this story includes the shortcomings of existing treatments and the pain and frustration of navigating the system," said Ekaterina Malievskaia. "I step down from the board convinced that the company is in good hands and on the right track financially, in its programs, and in preparation for a potential commercial launch to bring treatments to those in need. Innovation in mental health care remains as important to me as it was ten years ago, and I plan to continue to apply my experience and knowledge to the field."
"George and Katya leave an enduring legacy at Compass Pathways and across the field of mental health care," said David Norton. "Their leadership and compassion for people living with difficult-to-treat mental health conditions, their commitment to rigor and evidence, and their focus on ensuring broad and equitable access to innovation in mental health have moved us closer to achieving the vision they set when they launched the company: a world of mental wellbeing. Thanks to their leadership, Compass is in a strong position as it continues to execute its phase 3 program in treatment-resistant depression. We wish them all the best as they move into the next phase of their careers and continue their efforts to transform mental health care."
George and Ekaterina co-founded Compass Pathways in 2016. George served as Chief Executive Officer of the company from its founding until August 1, 2022, when Kabir Nath assumed the role. Ekaterina served as Chief Innovation Officer until she stepped down from her executive role in June 2023. This transition is a natural evolution as Compass has matured as a public company and progresses through late-stage clinical development and into commercial preparations.
Key accomplishments of their tenure at the company and on the board include:
David Norton is a former Company Group Chairman of Global Pharmaceuticals for Johnson & Johnson. He began his career with J&J in 1979 and held several positions across the company, including Company Group Chairman, Worldwide Commercial and Operations for the CNS/internal medicine franchise, Company Group Chairman for the pharmaceutical businesses in Europe, the Middle East and Africa, and Company Group Chairman for the pharmaceutical businesses in North America. He has been a member of the Compass board of directors since 2018, serving as lead independent director. He also serves on the board of directors of Forepont Capital.
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 current treatments. 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 been designated a Breakthrough Therapy by the U.S. 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 United States. Our vision is a world of mental wellbeing. www.compasspathways.com
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 "will", "may", "might", "could", "would", "should", "expect", "intend", "plan", "objective", "anticipate", "believe", "contemplate", "estimate", "predict", "potential", "continue" and "ongoing," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, Compass's expectations regarding its plans for a new board chair and Compass's expectations regarding its pivotal phase 3 program or other trials to support regulatory filings and approvals. 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: market risks and other market conditions; the timing and outcome of the Company's search for a new board chair; clinical development is lengthy and expensive process with uncertain outcomes, and therefore our clinical trials may be delayed or terminated and may be more costly than expected; we will require substantial additional funding to achieve our business goals and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our product development efforts; our efforts to obtain marketing approval from the applicable regulatory authorities in any jurisdiction for COMP360 or any future product candidates may be unsuccessful; establishing, maintaining, defending and enforcing our patents and other intellectual property rights covering our investigational COMP360 psilocybin treatment may be challenging and costly and our efforts to protect our patents and other intellectual property rights may be unsuccessful; our efforts to commercialize and to obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; our ability to successfully manage leadership changes; economic and geopolitical uncertainties 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.
Enquiries
Media: Amy Lawrence, amy@compasspathways.com , +44 7813 777 919
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324
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