Enhanced clinic enables greater access to ketamine and Spravato™ treatments
TORONTO, ON / ACCESSWIRE / January 13, 2021 / Novamind Inc. (CSE: NM) (“Novamind” or the “Company”), a mental health company specialized in psychedelic medicine, announces the expansion and optimization of its Cedar Psychiatry clinic in Layton, Utah (“Layton Clinic”), the largest clinic in the Company’s network.
The redesigned Layton Clinic now offers improved treatment rooms to accommodate a higher number of ketamine and Spravato™ (esketamine) treatments. The Layton Clinic expansion comes in response to a significant increase in demand for ketamine therapies across Novamind’s mental health clinics. In 2020 alone, the Cedar Psychiatry clinic network facilitated over 20,000 client visits, an increase of over 100 percent compared to the same period in 2019.
“The demand for mental health services continues to increase dramatically and we are responding by improving access to our most innovative treatments,” said Dr. Reid Robison, Chief Medical Officer and Director of Novamind. “The enhanced clinic layout enables us to serve more clients with evidence-based treatments, including ketamine and future FDA approved psychedelics.”
Cedar Psychiatry has gained years of experience in effectively managing the challenges associated with offering its clients access to novel medications such as Spravato™ and anticipated FDA-approved psychedelics. Cedar Psychiatry’s expertise includes inventory logistics, coordinating reimbursement with insurance providers and compliance with each medications’ unique Risk Evaluation and Mitigation Strategy (REMS).
“Enhancing service offerings at our Layton clinic goes to the heart of our mission, which is to increase our clients’ access to alternative mental health treatments,” said Yaron Conforti, CEO and Director of Novamind. “In 2021, Novamind will address the increasing demand for innovative mental health services by growing our network of Cedar Psychiatry clinics within Utah and into new jurisdictions.”
As a leading provider of ketamine therapy in the United States, Cedar Psychiatry has administered over 4,000 ketamine sessions and over 1,700 Spravato™ treatments since its founding in 2016. The Cedar Psychiatry clinic network has four locations in Utah, in Salt Lake City, Layton, Orem and Springville. For more information on the clinics, please visit our website.
About Novamind
Novamind is a leading mental health company enabling safe access to psychedelic medicine through a network of clinics, retreats, and clinical research sites. Novamind provides ketamine-assisted psychotherapy and other novel treatments through its network of Cedar Psychiatry clinics and operates Cedar Clinical Research, a contract research organization specialized in clinical trials and evidence-based research for psychedelic medicine. Both Cedar Psychiatry and Cedar Clinical Research are wholly-owned subsidiaries of Novamind. For more information on how Novamind is enhancing mental wellness and guiding people through their entire healing journey, visit novamind.ca.
Contact Information
Novamind
Yaron Conforti, CEO and Director
Telephone: +1 (647) 953 9512
Forward-Looking Statements
This news release contains forward-looking statements. All statements other than statements of historical fact included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations including the risks detailed from time to time in the Company’s public disclosure. The reader is cautioned not to place undue reliance on any forward-looking information. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable laws.
MindMed to Commence Groundbreaking LSD Microdosing Study Evaluating Benefits on Neuroplasticity, Sleep, Cognitive Enhancement Variables and Immune System Response on the Human Body
NEW YORK, Jan. 12, 2021 /PRNewswire/ — MindMed (NEO: MMED), (OTCQB: MMEDF), (DE: MMQ), a leading psychedelic medicine biotech company today announced an innovative randomized placebo-controlled study evaluating the effects of daytime and evening administration of low doses of LSD on cognitive performance, sleep quality, mood, neuroplasticity markers, emotion regulation, quality of life, and immune system response.
The study will provide an additional research pathway for MindMed’s psychedelic Microdosing Division and will immediately integrate with MindMed’s plans in digital therapeutics through its newly formed Albert unit for digital medicine. The new study will be conducted in collaboration with Dr. Kim Kuypers of Maastricht University in the Netherlands, a global, leading authority on the microdosing of psychedelics.
Dr. Kuypers said, “I am excited about this new study which combines a variety of measures ranging from self-reporting and cognitive tasks to health and sleep parameters, bringing us closer to the mechanism of action behind the claimed benefits of microdosing.”
In order to advance the scientific understanding of microdosing for clinical purposes, the randomized placebo-controlled study will specifically measure the effects of microdoses of LSD on neuroplasticity markers such as BDNF plasma levels, as well as on various sleep measures, mood, cognitive performance, emotion regulation, quality of life, and immune system response. MindMed is integrating innovative digital tracking devices and software into the study to better assess LSD’s effects on various digital clinical markers on the human body.
MindMed’s President and Head of Clinical, Dr. Miri Halperin Wernli, commented on the groundbreaking new study saying, “Over the past 15 years there has been growing interest in psychedelic microdosing and its potential enhancing effects on the human body. We now aim to use digital medicine techniques to expand the measurements enabling us to track and understand cognitive performance, various behavioral variables, productivity, and mood indicators. We believe that such measurements may offer an efficient way of determining a response loop for better understanding how microdosing can affect the human body. With this study we are seeking to gather scientific and controlled data that we hope will contribute to the discovery of potential therapeutic applications for these psychedelics microdosing paradigms as innovative treatment modalities.”
In addition to this study, MindMed’s Microdosing Division under the leadership of Dr. Halperin Wernli is undertaking a commercial Phase 2a Adult ADHD clinical trial evaluating microdoses of LSD. Dr. Kim Kuypers and Dr. Matthias Liechti will serve as principal investigators for the initial clinical trial of this commercial program.
About MindMed
MindMed is a leading psychedelic medicine biotech company that discovers, develops and deploys psychedelic inspired medicines and therapies to address addiction and mental illness. The company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including Psilocybin, LSD, MDMA, DMT and an Ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to the company’s groundbreaking approach to developing the next-generation of psychedelic inspired medicines and therapies.
MindMed trades on the Canadian exchange NEO under the symbol MMED. MindMed is also traded in the United States under the symbol MMEDF and in Germany under the symbol MMQ.
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and performance of Mind Medicine (MindMed) Inc. (“MindMed”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, MindMed’s and its collaborators’ ability to continue to conduct research and clinical programs, MindMed’s ability to manage its supply chain, product sales of products marketed by MindMed and/or its collaborators (collectively, “Products”), and the global economy; the nature, timing, and possible success and therapeutic applications of Products and Product candidates and research and clinical programs now underway or planned; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Product candidates and new indications for Products; unforeseen safety issues resulting from the administration of Products and Product candidates in patients, including serious complications or side effects in connection with the use of MindMed’s Products and product candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict MindMed’s ability to continue to develop or commercialize Products; ongoing regulatory obligations and oversight impacting Products, research and clinical programs, and business, including those relating to patient privacy; uncertainty of market acceptance and commercial success of Products and Product candidates and the impact of studies on the commercial success of Products and Product candidates; the availability and extent of reimbursement of Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; competing drugs and product candidates that may be superior to Products and Product candidates; the extent to which the results from the research and development programs conducted by MindMed or its collaborators may be replicated in other studies and lead to therapeutic applications; the ability of MindMed to manufacture and manage supply chains for multiple products and product candidates; the ability of MindMed’s collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labelling, distribution, and other steps related to MindMed’s Products and product candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of MindMed to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement to be cancelled or terminated without any further product success; and risks associated with intellectual property of other parties and pending or future litigation relating thereto, other litigation and other proceedings and government investigations relating to MindMed and its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on MindMed’s business, prospects, operating results, and financial condition. Any forward-looking statements are made based on management’s current beliefs and judgment. MindMed does not undertake any obligation to update publicly any forward-looking statement.
The strategic partnership between Mind Cure and ATMA will bridge access to research locations for psychedelic drug research while providing patient data for iSTRYM, Mind Cure’s digital therapeutics platform.
VANCOUVER, BC, Jan. 12, 2021 /CNW/ – Mind Cure Health Inc. (CSE: MCUR) (OTCQB: MCURF) (FRA: 6MH) (“Mind Cure” or the “Company”) is pleased to announce the signing of a non-binding letter of intent (the “LOI“) for strategic investment and commercial cooperation with ATMA Journey Centers Inc. (“ATMA“), a Calgary-based organization. ATMA is the first commercial treatment center in Canada to announce providing psychedelic-assisted therapy for a section 56 exempt patient. The LOI is intended to help Mind Cure secure an equity position within ATMA, empowering the Company with access to a global release strategy for iSTRYM, as well as international locations for translational research on novel molecules and treatment protocols.
“ATMA’s clinicians possess a proven track record of advocacy and innovation driving toward the therapeutic benefits of psychedelic medicine for patients in the treatment of mental health and wellness. Mind Cure is extremely excited to join ATMA in the renaissance that is disrupting mental health care by partnering with one of the pioneers in the therapeutic psychedelics industry,” said Kelsey Ramsden, President & CEO, Mind Cure. “With Mind Cure’s therapeutic tool, iSTRYM, along with ATMA’s pivotal achievement as the care provider for Canada’s most recent section 56(1) exempt patient, mental health care in Canada is making history. We are thrilled to work with the best-in-class to drive our focus on accelerating our research and technology platforms.”
Mind Cure’s partnership with ATMA is an exciting opportunity for researchers and therapists to participate in each of Mind Cure’s research programs focused on pain, neuroregeneration, migraines, and cluster headaches. The proposed investment will facilitate the syndication of Mind Cure’s psychedelic drug protocols and the use of Mind Cure’s proprietary technology, iSTRYM, to optimize treatment for ATMA clients.
The deployment of capital will also advance speed and scale for data enrichment of iSTRYM, providing the AI-driven platform with access to patient data as ATMA targets domestic and international healing and treatment centers.
“Psilocybin-assisted therapy offers healing and understanding that is unmatched by traditional methods. Patients dealing with end-of-life anxiety, pain, depression, trauma, and addiction have been at the mercy of ineffective and underwhelming treatments for much too long. The resources are here, and we are extremely grateful to be at the frontlines of this world-changing, innovative, and extremely alleviating solution, to help bring peace to sufferers,” said David Harder, co-CEO, ATMA Journey Centers Inc. “We are witnessing an inflection point for mental health treatment as the commitment to wellness in Canada takes a huge step forward.”
Pursuant to the LOI, the parties intend to negotiate the terms of definitive agreements (the “Definitive Agreements“), which will provide for, among other things an initial $500,000 investment by Mind Cure in ATMA, participation by Mind Cure in ATMA’s future financings, and the exclusive use of iSTRYM throughout ATMA’s business. There can be no assurance that the Definitive Agreements will be entered into or that the investment or commercial transactions will be completed on the terms proposed in the LOI or at all.
About ATMA Journey Centers Inc. and SYNTAC Institute
ATMA is a private healthcare company with the mission of delivering effective and innovative healing and transformative experiences that awaken the inner healer and promote a deeper connection with the self, with others, and with the beauty of the world. ATMA is the first private sector service provider in Canada to announce psychedelic-assisted therapy provision under the approval of Health Canada’s Section 56(1) exemption, which will allow ATMA to provide psilocybin-assisted therapy to those seeking psychedelic assisted therapy.
ATMA’s founding members, David Harder, Greg Habstritt, and Vu Tran, also founded SYNTAC Institute, a non-profit organization with the mission of bringing the healing and transformative power of psychedelic medicine and psychedelic-assisted therapy to Canadians. SYNTAC has been an influential participant in the Canadian psychedelic medicine industry and operates Catalyst Presents, a series of conferences and summits in Canada focused on psychedelics.
About Mind Cure Health Inc.
Mind Cure exists as a response to the current mental health crisis and urgent calls for effective treatments. Mind Cure believes in the need to reinvent the mental health care model for patients and practitioners to allow psychedelics to advance into common and accepted care.
Mind Cure is focused on identifying and developing pathways and products that ease suffering, increase productivity, and enhance mental health. Mind Cure is interested in exploring diverse therapeutic areas beyond psychiatry, including digital therapeutics, neuro-supports, and psychedelics, all to improve mental health.
On Behalf of the Board of Directors
Kelsey Ramsden, President & CEO
Phone: 1-888-593-8995
Forward-Looking Information
Certain statements in this news release may constitute “forward-looking information” within the meaning of applicable securities laws (also known as forward-looking statements). Forward-looking information involves known and unknown risks, uncertainties and other factors, and may cause actual results, performance or achievements or industry results, to be materially different from any future results, performance or achievements or industry results expressed or implied by such forward-looking information. Forward-looking information generally can be identified by the use of terms and phrases such as “anticipate”, “believe”, “could”, “estimate”, “expect”, “feel”, “intend”, “may”, “plan”, “predict”, “project”, “subject to”, “will”, “would”, and similar terms and phrases, including references to assumptions. Some of the specific forward-looking information in this news release includes, but is not limited to, statements with respect to: the conclusion of the transactions and negotiation of the Definitive Agreements contemplated by the LOI on the terms disclosed herein, or at all; ATMA conducting additional psychedelic-assisted therapy; the disruption of mental health care through psychedelic-based therapies; the development of iSTRYM and incorporation into ATMA’s business; the relationship with ATMA accelerating the development of Mind Cure’s research and technology platforms; participation of researchers and therapists in Mind Cure’s research programs; Mind Cure’s investment facilitating the syndication of Mind Cure’s psychedelic drug protocols and the development of those protocols; protocols and iSTRYM to optimize treatment for ATMA clients and driving greater access to patient data for the AI-driven digital therapeutics platform; the roll-out of domestic and international treatment centres by ATMA; the realization of an inflexion point for mental health treatment; and Mind Cure’s collection of data from ATMA’s section 56 exempt clients.
Forward-looking information is based on a number of key expectations and assumptions made by Mind Cure, including, without limitation: the COVID-19 pandemic impact on the Canadian economy and Mind Cure’s business, and the extent and duration of such impact; no change to laws or regulations that negatively affect Mind Cure’s business; there will be a demand for Mind Cure’s products and ATMA’s clinics in the future; no unanticipated expenses or costs arise; Mind Cure will be able to continue to identify products that make them ideal candidates for providing solutions for treating mental health; the partnership with ATMA will help Mind Cure achieve its business goals; and Mind Cure will be able to operate its business as planned. Although the forward-looking information contained in this news release is based upon what Mind Cure believes to be reasonable assumptions, it cannot assure investors that actual results will be consistent with such information.
Forward-looking information is provided for the purpose of presenting information about management’s current expectations and plans relating to the future and readers are cautioned that such statements may not be appropriate for other purposes. Forward-looking information involves significant risks and uncertainties and should not be read as a guarantee of future performance or results as actual results may differ materially from those expressed or implied in such forward-looking information. Those risks and uncertainties include, among other things, risks related to: the impacts of the COVID-19 pandemic on the Canadian economy, Mind Cure’s industry and Mind Cure’s business, which may negatively impact, and may continue to negatively impact, Mind Cure and may materially adversely affect Mind Cure’s investments, results of operations, financial condition, and Mind Cure’s ability to obtain additional equity or debt financing, and satisfy its financial obligations; general economic conditions; future growth potential; competition for mental health and wellness investments; Mind Cure’s partnership with ATMA may not help Mind Cure achieve its business goals; iSTRYM, and its database function may not be successfully developed or help to optimize protocols and enhance scientific research; and changes in legislation or regulations. Management believes that the expectations reflected in the forward-looking information contained herein are based upon reasonable assumptions and information currently available; however, management can give no assurance that actual results will be consistent with such forward-looking information. Additional information on the risk factors that could affect Mind Cure can be found under “Risk Factors” in Mind Cure’s final prospectus which is available on SEDAR at www.sedar.com.
The forward-looking information contained herein is expressly qualified in its entirety by this cautionary statement. Forward-looking information reflects management’s current beliefs and is based on information currently available to Mind Cure. The forward-looking information is stated as of the date of this news release and Mind Cure assumes no obligation to update or revise such information to reflect new events or circumstances, except as may be required by applicable law.
The CSE has neither approved nor disapproved the contents of this press release and the CSE does not accept responsibility for the adequacy or accuracy of this release.
SOURCE Mind Cure Health Inc.
For further information: Investor Relations: investors@mindcure.com 1-888-593-8995
— Phase II Clinical Trial Expected to Commence First Half of 2021 —
NEW YORK, Jan. 12, 2021 /PRNewswire/ — atai Life Sciences (“atai” or the “Company”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced that it has acquired a majority stake in Recognify Life Sciences (“Recognify”), an entity developing a treatment for Cognitive Impairment associated with Schizophrenia (“CIAS”). Recognify’s lead compound, “RL-007”, previously called FSV7-007, has exhibited a modulating effect on three mechanisms that are central to learning and memory: the cholinergic, NMDA and GABA type B receptor systems.
Recognify’s RL-007 is a Phase II ready asset that has previously been evaluated in nine clinical studies – seven Phase I studies and two Phase II studies – with a total of 508 unique subjects having been dosed to date. Importantly, three of these clinical trials demonstrated improvements in verbal learning and memory, including in a large Phase II study of subjects with peripheral neuropathic pain.
RL-007 preliminarily exhibited pro-cognitive effects on exploratory endpoints in pain patients, an experimental cognitive paradigm, and healthy volunteers. Preclinically, it demonstrated pro-cognitive effects in healthy young animals, age-associated memory loss, and models of cholinergic-deficits. RL-007 also showed anxiolytic properties in animal models of unconditioned anxiety. Finally, it has been shown to enhance long term potentiation in rat hippocampal slices, indicating a direct action on mechanisms and brain regions involved with learning and memory processes.
“Millions of people suffer from CIAS globally, and it is a very damaging disorder that can often lead to dire consequences. In part, this is due to the cognitive deficits associated with the condition,” said Srinivas Rao, MD, PhD, Co-Founder & Chief Scientific Officer of atai Life Sciences. “Currently, there is a large patient population with unmet medical needs as there are no approved treatments for CIAS. We find the previous studies of RL-007 to be very promising in its modulating effect and look forward to launching our Phase II clinical trial focused on its use as a treatment of CIAS.”
“We are highly encouraged by the pro-cognitive results observed in the RL-007 clinical trials to date,” added Matthew Pando, PhD, CEO and Co-Founder of Recognify Life Sciences. “It is our privilege to join the atai family to further demonstrate the clinical potential of this compound, in particular, in the treatment of CIAS. atai will provide the necessary resources and support to advance Recognify Life Sciences to the next stage.”
“RL-007 is unique in that it enhances mechanisms of neuronal signaling, learning and memory, but apparently without the side effects associated with other compounds acting on these mechanisms,” said Dr. Thomas Südhof, Co-Founder of Recognify Life Sciences and 2013 Nobel laureate in Physiology or Medicine. “The combination of its pro-cognitive effects and safety profile make it an ideal candidate to treat CIAS patients and other fragile patient populations suffering from cognitive decline.”
About atai Life Sciences
atai is a clinical-stage biotechnology company aiming to transform the treatment of mental health disorders. The Company was founded in 2018 as a direct response to the significant and growing unmet needs of mental health patients worldwide, lack of innovation and new insights into substances that may be overlooked or underused in the mental health treatment landscape, including psychedelic compounds and digital therapeutics. atai’s platform model combines funding, enabling technologies, supportive infrastructure and personnel with deep expertise to build programs focused on psychedelic and other compounds having differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai endeavors to responsibly accelerate the development of new medicines across its business entities, seeking to bridge the gap between what the mental healthcare system currently provides and what patients need. atai is headquartered in Berlin, with offices in New York and San Diego. For more information, please visit www.atai.life.
Vancouver, British Columbia, Canada – January 12, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD62, WKN: A2P8K3) (the “Company”) is pleased to announce its plans to initiate another intellectual property strategy that will utilize its patented transmucosal thinstrip delivery method (“thinstrip delivery method”) in combination with its proprietary biosynthetic psilocybin, developed by its wholly-owned subsidiary, Vocan Biotechnologies Inc. (“Vocan”).
The Company’s existing thinstrip delivery method has been patented for use with THC and CBD (CannaStripsTM) and has the potential for use with all naturally occurring compounds, including psilocybin
Through cutting-edge research by the Company’s team at Vocan, a cost effective method for producing biosynthesized psilocybin has been developed. This low cost method of psilocybin production, in combination with the incorporation of psilocybin into the Company’s thinstrip technology, will result in an innovative and first-to-market delivery method of psilocybin for medical purposes.
Core One’s objective in developing the psilocybin thinstrips is to assist with the delivery of revolutionary psychedelic treatment methods to address mental health conditions such as depression, anxiety and addictions.
Methods of accurate dosing and effective delivery of psilocybin have gone relatively under-researched, and current methods utilized by companies using traditional oral delivery methods can cause hallucinations, digestive issues, and inaccurate dosages resulting in undesired side effects. The Company’s patented sublingual transmucosal (orally dissolvable) thinstrip technology, for the delivery of psilocybin, will aim to address these issues, and anticipates the provision of many potential advantages and benefits such as the rapid dissolving and onset of action to the bloodstream, as well as concentration control and time released dosing. Thinstrip delivery technology is a natural, non-toxic, biodegradable, biocompatible composite, which is user friendly. The sublingual polymer thinstrip, with nano particulated active ingredients, skips the digestive system and is absorbed directly into the bloodstream through the membranes in the mouth, resulting in optimum bioavailability (absorption percentage) of the active ingredients. Direct delivery to the bloodstream means that dosages can be less potent with the same affect.
According to the World Health Organization, almost 350 million people worldwide were affected by depression in 2016. Common antidepressant drugs help maintain the balance of various hormones and chemicals in the brain which assists in the treatment of depression.
The Center for Disease Control and Prevention (CDC), reported that the percentage of people above the age of 12 years using antidepressants in the U.S. rose 12.7% in 2011-2014. According to MedGadget, the antidepressant drug market was valued at $13.69 billion in 2018 and is expected to reach $15.88 billion by 2025. The CDC said that in the U.S., antidepressants were the most commonly prescribed drugs in 2013 and from over 16 million long term users, around 70% are female.
“One of the critical issues surrounding the use of psilocybin is accurate dosing in oral delivery methods. Our breakthrough technology is a game changer in the psychedelic space and has the potential to revolutionize the way patients receive psychedelics as medicine and reduce over concentrations and resulting adverse effects.” stated Dr. Robert E.W. Hancock, Executive Chairman of the Company.
About Core One Labs Inc.
Core One Labs Inc. is a research and technology company focused in life sciences and on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy. The Company has developed a patent pending thin film oral strip (the “technology”) which dissolves instantly when placed in the mouth and delivers organic molecules in precise quantities to the bloodstream, maintaining excellent bioavailability. With this technology, the Company intends to further develop its technology to focus on delivering psychedelic molecules with an initial focus on psilocybin. Core One also holds an interest in walk-in medical clinics which maintain a database of over 200,000 patients combined. Through research and development in these clinics, including the integration of its intellectual property related to psychedelic treatments and novel drug therapies, the Company intends to work towards regulatory approval for research that advances psychedelic-derived treatments for mental health disorders.
Core One Labs Inc.
Joel Shacker
Chief Executive Officer
FOR MORE INFORMATION, PLEASE CONTACT:
info@core1labs.com
1-866-347-5058
Cautionary Disclaimer Statement:
The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.
Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management’s current estimates, beliefs, intentions and expectations. They are not guarantees of future performance. The Company cautions that all forward looking statements are inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Such factors include, among other things: risks and uncertainties relating to the Company’s limited operating history and the need to comply with environmental and governmental regulations. In addition, marijuana remains a Schedule I drug under the United States Controlled Substances Act of 1970. Although Congress has prohibited the US Justice Department from spending federal funds to interfere with the implementation of state medical marijuana laws, this prohibition must be renewed each year to remain in effect. Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information. In addition, psilocybin is currently a Schedule III drug under the Controlled Drugs and Substances Act (Canada) and it is a criminal offence to possess substances under the Controlled Drugs and Substances Act (Canada) without a prescription. Health Canada has not approved psilocybin as a drug for any indication. Core One Labs Inc. does not have any direct or indirect involvement with illegal selling, production, or distribution of psychedelic substances in jurisdictions in which it operates. While Core One Labs Inc. believes psychedelic substances can be used to treat certain medical conditions, it does not advocate for the legalization of psychedelics substances for recreational use. Core One Labs Inc. does not deal with psychedelic substances, except within laboratory and clinical trial settings conducted within approved regulatory frameworks.
With so many new IPOs and companies launching in the psychedelic industry it’s important to fully evaluate the major factors of success or failure in the industry. There are various steps that companies take to have a drug approved and to successfully complete them it takes years and tens of millions of dollars. The further ahead a company moves in the approval process, the more valuable the company becomes, and that is why there is so much excitement for Compass Pathways (CMPS) . Institutional and retail investors are in a frenzy to get a position. The company is in Phase 2b and has received a “Breakthrough Therapy” designation from the FDA, meaning that their therapy has the potential to be more effective than available medications.
Currently there are only a handful of companies that have:
Access to psychedelic compounds
A clear idea of the disorder they are targeting, also known as drug indication
Are actively running a clinical trial.
It’s important for investors to be mindful of the stage a company is in and to fully evaluate if a company they are investing in has the potential to be successful.
The only companies that have Phase 2 clinical trials now are Compass Pathways, Mind Medicine (MMEDF) , Cybin Inc. (CLXPF) , and Mydecine Innovations Group (MYCOF) . Here’s an analysis of these biotech players and we highlight the most undervalued company in the industry.
What is the Drug Discovery Process?
The drug development process being undertaken is to ensure these treatments are safe and effective for consumption.
The drug is investigated and screened tested on animals to prove safety (can be skipped since psilocybin has been proven safe and effective)
Investigational drug application to FDA and Health Canada is submitted that includes, drug composition, formulation and manufacturing process
Clinical Trial Plan including selection of location
Recruitment of volunteers
Analysis of findings and submission
Approved to move to next Phase in larger population
Psychedelic Companies with Phase 2 Trials Valuation Comparison
Biotechnology companies are hard to value as it’s hard to predict success of clinical trials. Biotech companies are unique types of investments that can either pay off handsomely or end with a complete loss of capital. One of the best ways to value a company is by looking at the size of the addressable market and estimating the potential market penetration.
The reason Compass Pathways is leading the charge in psychedelics is they have a drug that is more effective than anything available, has a total addressable market of 16 million adults, and can upend this entire market as a whole.
What key parameters to look for valuing biotech companies?
Experienced Science team
Experienced Management Team
Intellectual property protection
Large addressable market
Potential Market Penetration Possible
Access to patients
Access to active ingredients
Unique R&D Capabilities
Scientific Community Collaborations
Compass Pathways
COMPASS Pathwaysoperates as a mental health care company in the UK and the U.S. It develops COMP360, a psilocybin formulation, which is in Phase IIb clinical trial to treat patients with treatment-resistant depression. The company is currently the most valuable and most well-known company in the industry and has raised over $250 million since its inception.
Current Market Cap: $1.57 Billion
Drug in development: COMP360 Psilocybin for Depression
Indication: Treatment Resistant Depression
Total Addressable Market: $1.12 billion by 2024
Stage: Phase 2B
Location: Multiple sites globally
Mind Medicine Inc.
Mind Medicine, also known as MindMed, is a neuro-pharmaceutical company that discovers, develops and deploys psychedelic inspired medicines to improve health, promote wellness and alleviate suffering. The company’s immediate priority is to address the opioid crisis by developing a non-hallucinogenic version of the psychedelic ibogaine. In addition, the company has established a microdosing division to conduct clinical trials of LSD microdosing for adult ADHD. The company has also added MDMA to its R&D pipeline to explore MDMA’s potential to treat mental health disorders.
Current Market Cap: $977 Million
Drugs in development: LSD for Adult ADHD, LSD for Suicide Headaches, Ibogaine for Addiction
Indication: Various
Total Addressable Market: Unknown but the largest of all studied companies
Stage: Phase 2a
Location: Multiple sites globally
Cybin Inc.
Cybin is a life sciences company advancing psychedelic pharmaceutical treatments for various psychiatric and neurological conditions. Cybin is developing technologies and delivery systems, aiming to improve bioavailability, to potentially achieve the desired medicinal effects of psychedelics at low dosage levels. The new delivery systems are expected to be studied through clinical trials to confirm safety and efficacy.
Current Market Cap: $203 Million
Drug in development: Sublingual Psilocybin Delivery Mechanism for Depression
Indication: Major Depressive Disorder
Total Addressable Market: $5.8 billion by 2025
Stage: Phase 2 A
Location: University of West Indies Jamaica
Mydecine Innovations Group
Mydecine Innovations Group is a life sciences company dedicated to developing and commercializing innovative solutions for treating mental health problems and enhancing well-being. The company’s world-renowned medical and scientific advisory board is progressing a robust R&D pipeline of psychedelic derived therapeutics, novel compounds, therapies, and controlled drug delivery systems. Mydecine has exclusive access to a full cGMP certified pharmaceutical manufacturing facility with the ability to import/export, extract, and analyze natural and synthetic psychedelic compounds with full government approval through Health Canada.
Mydecine was the first company to offer CGMP naturally sourced psilocybin and recently made history again by making the first legal export of Magic Mushrooms. Mydecine has a big focus on intellectual property and is utilizing genome technology (editing plants like what GW Pharma did in Cannabis) under the leadership of Rob Roscow the ex-Canopy Growth (CGC) head of genetics and at Mydecine’s U.S. and Canadian laboratories. The company now has over 20 kilos of psilocybin mushrooms – most in the industry – and has active ingredients for their trials at a fraction of the cost that Compass Pathways or Cybin ever can with their synthetic drugs.
Current Market Cap: $56 Million
Drug in development: Naturally Sourced Psilocybin
Indication: PTSD
Total Addressable Market: $10.6 B by 2026
Stage: Phase 2 A
Location: Multiple Sites Globally
As illustrated above, by making side by side comparisons of companies that are in Phase 2 trial studies, investors can quickly see the size of the addressable audience and the market cap of the company. This makes it easier to see if there is a stock that might have more room for upside than others. As the focus on psychedelic stocks increases, so do the valuations. There is concern that some company valuations have gotten ahead of themselves and investors may want to take that into consideration before hitting the buy button.
DENVER, Jan. 11, 2021 (GLOBE NEWSWIRE) — Mydecine Innovations Group (CSE: MYCO) (OTC: MYCOF) (FSE: 0NFA (“Mydecine” or the “Company’), an emerging biopharma and life sciences company committed to the research, development, and acceptance of alternative nature-sourced medicine for mainstream use, announced that it has appointed veteran corporate finance and capital markets professional, Gordon Neal to the Board of Directors. Additionally, Dean Ditto has joined the Company as Chief Financial Officer.
“MYCO continues to augment its C-Suite and board of directors with key independent, professional members to provide oversight into our governance policy to meet anticipated capital markets initiatives slated for this year,” said Josh Bartch, Chairman & CEO of Mydecine. “MYCO welcomes capital markets and governance veteran, Gordon Neal, as an independent director who, with his many years of board, board committee, and oversight experience will be invaluable in our corporate deliverables. Likewise, the addition of Dean Ditto as CFO will contribute to the Company’s commitment of strengthening internal controls, audit oversight and risk mitigation. His tenure with a Big 4 public accountant firm combined with 20 years of financial leadership makes him an added asset to our C-Suite team.”
“I thoroughly believe in the potential of psychedelic-assisted psychotherapy and I’m honored to have this opportunity to help Mydecine’s team be successful in the company’s future product commercialization efforts,” said Mr. Neal. “Over the years, as the founder of Neal McInerney Investor Relations, I was involved in marketing more than $4 billion in debt and equity financings as well as providing capital market strategies to multi-national companies and my passion for bringing innovative new therapies to the market for patients perfectly aligns with Mydecine’s mission as a global leader in the psychedelic space.”
“I have a profound belief in Mydecine’s vision and mission,” said Mr. Ditto. “The Company’s commitment to developing treatments for veterans and others suffering from PTSD has resonated deeply with me. I look forward to working with the entire team to help shape the future of the Company.”
About Gordon Neal
Gordon Neal has more than 35 years’ experience in governance, corporate finance and investor relations. He founded Neal McInerney Investor Relations in 1991. Through marketing more than $4 billion in debt and equity financings, his company grew to be the second largest full-service Investor Relations firm in Canada with offices in Vancouver, Toronto and Los Angeles. His clients included; BCE, Nortel, Bell Canada International, Bell Mobility, Clearnet, Intrawest, Canaccord Capital, BMO Nesbitt Burns, and Blackberry (RIM). Prior to that, Mr. Neal was VP Corporate Development at MAG Silver Corp. where he provided capital market strategies and solutions to the board. He is currently the President of New Pacific Metals Corp. Mr. Neal has served on the boards of Falco Resources, Balmoral Resources, Americas Petrogas, Rockgate Capital, and Xiana Mining. Mr. Neal has raised more than $500 million for resources companies since 2004. Mr. Neal graduated from Dalhousie University with a B.Sc. in Biochemistry. He has also served as a member of the Dalhousie University Senate and Board of Governors.
About Dean Ditto
Dean Ditto is an experienced CFO who has helped middle market companies elevate the financial function, secure capital, drive growth and improve profits. He joins Mydecine from Sigue Corporation where he served as CFO and was responsible for leading the finance team in business planning, budgeting, financial analysis and accounting. In addition, he was a Big 4 public accountant at PricewaterhouseCoopers before progressing to leadership roles with increased responsibilities, including C-suite and corporate officer roles. His areas of expertise include SEC reporting, treasury, internal audit, controls, tax, risk management, compensation planning, facilities, vendor programs, payroll and 401k. His key accomplishments include leading a financial services company through a business turnaround that improved annual profits by $15 million through managing costs, restructuring debt, and discontinuing unprofitable operations. Mr. Ditto’s professional certifications include Certified Public Accountant and Certified Internal Auditor and he earned his MBA degree from the Kelley School of Business, Indiana University.
About Mydecine Innovations Group
Mydecine Innovations Group™ is a life sciences company dedicated to developing and commercializing innovative solutions for treating mental health problems and enhancing wellbeing. The company’s world-renowned medical and scientific advisory board is progressing a robust R&D pipeline of psychedelic derived therapeutics, novel compounds, therapies, and controlled drug delivery systems. Mydecine has exclusive access to a full cGMP certified pharmaceutical manufacturing facility with the ability to import/export, extract, and analyze natural and synthetic psychedelic compounds with full government approval through Health Canada.
For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR atwww.sedar.com or visit the Company’s website atwww.mydecine.com.
The Canadian Securities Exchange has neither approved nor disapproved the contents of this news release and accepts no responsibility for the adequacy or accuracy hereof. This news release contains forward-looking statements, which relate to future events or future performance and reflect management’s current expectations and assumptions. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation. This news release does not constitute an offer to sell securities and the Company is not soliciting an offer to buy securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. This news release does not constitute an offer of securities for sale in the United States. These securities have not and will not be registered under United States Securities Act of 1933, as amended, or any state securities laws and may not be offered or sold in the United States or to a U.S. Person unless so registered, or an exemption from registration is relied upon.
Appointments Complete New Top Management Team Under Leadership of Chairman and CEO Dr. Roger McIntyre
VANCOUVER, BRITISH COLUMBIA – January 11, 2021 – Champignon Brands Inc. (the “Company”), (CSE: SHRM) (FWB: 496) (OTCQB: SHRMF), Chairman and CEO Roger McIntyre today announced the Company’s appointment of Stephen R. Brooks as its new Chief Financial Officer and Peter Rizakos as the firm’s new General Counsel.
These appointments complete the Company’s new top management team put into place by Dr. McIntyre and the Champignon Board of Directors. Dr. McIntyre stated, “these new management additions ready us for the future where the Company’s clinical products and services will help meet the enormous public need that is creating significant public demand for improved, ketamine-based treatments that are capable of rapid response in persons with depression.”
Interim CFO Chris Hobbs, named to that position on December 8, 2020, pending the recruitment of a new CFO, remains with the Company as special adviser to Mr. Brooks concerning the British Columbia Securities Commission (BCSC) continuous disclosure review and cease trade order (CTO).
Dr. McIntyre applauded Mr. Hobbs “leadership, competence and professionalism” in taking over these duties on an interim basis in a complete and cooperative response to the BCSC process.
The Company’s growth strategy is international in scope and is proceeding even while the Company works with the BCSC toward conclusion of the continuous disclosure review, the lifting of the CTO and the resumption of trading of the Company’s securities on the Canadian Securities Exchange.
Dr. McIntyre said Champignon’s depression clinic network continues to emerge with current and imminent openings of treatment centres in Toronto, Ottawa, and Montreal. The expansion of the network will continue through Champignon’s Canadian Rapid Treatment Centre of Excellence (CRTCE).
Chief Financial Officer, Stephen R. Brooks
Stephen Brooks is a seasoned finance professional with over 25 years experience across a range of industries including telecommunications, sports, entertainment, media, and retail.
Mr. Brooks was formerly Chief Financial Officer of Sim International, a television and movie service provider, CFO of the Ottawa Senators NHL hockey club and Senior Vice-President, Business Operations, of the Toronto Blue Jays and Rogers Centre.
Prior to this, Mr. Brooks spent several years in senior finance roles with Rogers Communications Inc. and Rogers Media Inc., including having responsibility for US and Canadian public reporting requirements.
General Counsel, Peter Rizakos
Peter Rizakos brings to the position of General Counsel 30 years of experience as a corporate and securities lawyer and as an executive in a variety of roles in both established and early-stage businesses.
Most recently, Mr. Rizakos was President and CEO of a private mining company and General Counsel for Marret Asset Management Inc., a Canadian asset manager. He was also top legal officer for one of Canada’s leading investment fund companies.
Peter has extensive experience with both public and private companies, including implementation of growth strategies, capital-raising and asset acquisition, legal and regulatory compliance and on board and governance matters.
Professional Affiliations
Stephen Brooks served 10 years in public practice with Deloitte & Touche, LLP in Vancouver, UK, and New York. He is a Chartered Accountant and Chartered Professional Accountant in Ontario and BC and an alumnus of the University of British Columbia and Harvard Business School.
Peter Rizakos articled and practiced law at Blakes in Toronto. He is a member of the Law Society of Ontario, has an MBA from INSEAD and LLB from Osgoode Hall Law School.
Champignon Brands Inc. (https://braxiascientific.com) is a research-driven company specializing in breakthrough ketamine treatment for depression and other mental health conditions. The Company works closely with subsidiaries including AltMed Capital Corp. (“AltMed”). The Canadian Rapid Treatment Center of Excellence is wholly owned by AltMed.
ON BEHALF OF THE BOARD
“Dr. Roger McIntyre“ Dr. Roger McIntyre Chairman & CEO
Call emergency medical services immediately if you believe you are experiencing a medical emergency. Do not rely on communication through the Champignon Brands website of the emails/telephone numbers above for urgent medical needs. Champignon Brands Inc. does not provide medical advice. If you have any specific medical questions or are seeking advice, please consult with your health care provider.
Individual and institutional investors as well as advisors are invited to log-on to VirtualInvestorConferences.com to view the presentations
NEW YORK, Jan. 11, 2021 /PRNewswire/ — Virtual Investor Conferences® and KCSA Strategic Communications today announced that the presentations from the January 7th Cannabis Industry Virtual lnvestor Conference are now available for on-demand viewing at VirtualInvestorConferences.com.
All presentations will be available for 24/7 on-demand replay for 90 days. Investors, advisors and analysts may also download shareholder materials from the “virtual trade booth” for the next three weeks.
The following companies participated in the conference:
To facilitate investor relations scheduling, for more information about the program and to view a complete calendar of Virtual Investor Conferences, please visit
www.virtualinvestorconferences.com.
About Virtual Investor Conferences®
Virtual Investor Conferences is the leading proprietary investor conference series that provides an interactive forum for publicly-traded companies to meet and present directly with investors.
A real-time solution for investor engagement, Virtual Investor Conferences is part of OTC Market Group’s suite of investor relations services specifically designed for more efficient Investor Access. Replicating the look and feel of on-site investor conferences, Virtual Investor Conferences combine leading-edge conferencing and investor communications capabilities with a comprehensive global investor audience network.
About KCSA Strategic Communications
KCSA is a fully integrated communications agency specializing in public relations, investor relations and social media, with expertise in financial and professional services, technology, healthcare, digital media and cannabis. Since 1969, the firm has demonstrated strategic thinking and program execution that drives results for its clients in the ever-changing communications and digital landscape. The firm’s clients are its best references. For more information, please visit www.kcsa.com.
Cardinal Capital Partners and MindHealth BioMed Receives CSE
Conditional Listing Approval
Toronto, Ontario– – Cardinal Capital Partners Inc. (the “Company” or “Cardinal”) and MindHealth Biomed Corp. (“MindHealth”, and together with Cardinal, the “Parties”) are pleased to announce that they have received conditional approval from the Canadian Securities Exchange (the “CSE”) for listing of the common shares of the Company (the “Common Shares”) following the completion of the reverse takeover transaction (the “Transaction”) with Cardinal. Completion of the Transaction is subject to the satisfaction or waiver of conditions typical for a transaction of this nature. Listing on the CSE is subject to
completion of the Transaction the filing of standard documentation with the CSE.
It is expected that Cardinal will be re-named “Psyence Group Inc.” following the Transaction. For more details about the Transaction, see Cardinal’s news release dated September 14, 2020. Psyence Group Inc. intends to be a global platform for business and innovation leading the way in naturally derived psychedelic therapy and the development and commercialization of related technologies and products. The Parties are also pleased to advise that Cardinal and MindHealth shareholders voted 100% in favour of the Transaction in their respective Shareholder Meetings.
About Psyence Group
The Psyence Group intends to set the global standard for natural psychedelics. The executive team have international experience in the business of science-and medicine and include global experts in neurology, neuroscience and drug development. Psyence has built and operates one of the first federally licensed commercial psilocybin cultivation and production facilities. Psyence are pioneering the use of natural psilocybin for the long-term treatment of psychological trauma and its mental health consequences. The Psyence Group have a global footprint operating across multiple legal jurisdictions, through the advanced
provision of psychedelic therapy and experience, as well as market leading functional mushroom brands and product portfolio.
Psyence Contact Information
Lisa-Marie Iannitelli, Investor Relations
Email: ir@psyence.com
Website: www.psyence.com
Media Inquiries: media@psyence.com
General Information: info@psyence.com
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