Mydecine Innovations Group (NEO: MYCO) is a company we’ve been watching closely over the past several months. The company was just recently listed on the NEO stock exchange, and we had CSO Rob Roscow by to speak with us recently on about Mydecine’s phase 2 clinical trials on PTSD. To learn more, we’ve also invited Dr. Rakesh Jetley, Mydecine Chief Medical Officer, to discuss how in his perspective, a psychedelic experience may not just be key for treating PTSD but may teach us a great deal about how psychedelics make the brain open to new ideas.
Here’s a few of the highlights:
“Something unique” about veterans and combat veterans
Dr. Jetley “came to the trauma world naturally,” he says. He served for 31 years in the military, and in that time, he was deployed to Rwanda, the middle east, and Kandahar. He experienced firsthand the feeling of helplessness that even missions of peacekeeping can bring in the face of atrocities. “All of those kinds of operational experiences take a toll in different ways on people,” Jetley says.
Around 2000, the Canadian armed forces began PTSD clinics, and Dr. Jetley worked closely with them as Director and psychiatrist. He began with all the best evidence-based treatments and practices to treat PTSD. However, after a number of years, Jetley says “you become the second opinion guy.” The failure to treat some cases of PTSD made him open to exploring treatment combined with a psychedelic experience.
Jetley emphasizes he’s not trying to diminish the suffering of victims of sexual trauma, physical violence, or motor accidents. But the reality is that combat veterans in particular responded less well to evidence-based treatments currently available – as many as half of the veteran patients responded poorly or not at all.
What makes them so different?
PTSD in combat veterans is complicated, and there is no one reason to blame as the cause for current modes of PTSD treatment being ineffective. Jetley says that the nature of the trauma could be a factor, that there are multiple traumas over a time as opposed a single episode. It could be that it’s coupled with traumatic grief if they have lost colleagues while serving. Or it could be a newer concept that Dr. Jetley says he and some of his peers have been exploring, which they call “moral injury” – guilt and shame coming from transgressions witnessed or things they haven’t done.
There’s also complications that arise due to ethos and conditioning. A soldier’s ethos, Jetley says, is mission first, family second, ‘me’ third. And when you become ill or injured, you have to reverse that pyramid, put yourself even ahead of your family.
How a psychedelic experience might help veterans suffering from PTSD
That ethos is why Dr. Jetley says “… we have trouble accessing the emotions, the feelings, just partly based on the psyche, based on the conditioning, based on how they’re trained.” So Jetley thought a psychedelic might cause necessary changes in brain and perspective. Veterans with PTSD are being given one to three psychedelic experiences over a few weeks or months coupled with psychotherapy.
The results so far? “We’ve never seen something like this before,” Jetley says. The psychedelic experience combined with psychotherapy and more traditional psychotherapeutic techniques seems to hold better and make lasting changes.
How do you take a product of nature, recognize its medical potential and turn that into a medicine that’s reliable in clinical practices? That is a question Mydecine Innovations Chief Science Officer Rob Roscow contemplates every single day as he drives towards fulfilling the objectives of Mydecine’s three main operational pillars: IP/R&D, Clinical Trials and Technology.
An experienced research head, Mr. Roscow has been in this position before. Prior to joining Mydecine Innovations last May, he served as Director of Research at Ebbu, a multi-platform cannabinoid research and technology firm based in Colorado. He was tasked with activities such as operating the world’s first cannabis genomic editing facility, focusing on cannabinoid yield enhancements, filing patents, and developing a cannabis tissue culture lab.
Ebbu’s subsequent $429 million acquisition by Canopy Growth provided the segue for Mr. Roscow to focus his attention on the transformational medical mushroom space by co-founding Mydecine Group.
Among Mr. Roscow’s primary tasks will be to integrate Mydecine’s industry-leading MindLeapHealth platform across in assisted-therapy apparatus. The base technology has many benefits by allowing users to track their mood and habits pertaining to mental health over time. It also allows user to interact with a catalog of activity with their therapist to achieve optimal outcomes.
Telemedicine apps have become an integral part of today’s post-COVID landscape, with Mydecine CEO Josh Bartch recently estimating that: “Seven-tenths or eight-tenths of the equation are one-on-one psychotherapy meetings between psychotherapists and patients with no substances taken at all.” The company views MindLeap as a critical platform to properly integrate and scale with the majority pf patient interactions conducted away from a physical office.
According to Grand View Research, the global telemedicine market size was estimated at USD 55.9 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 22.4% from 2021 to 2028.
In the embedded interview, Rob Roscow goes into granular detail on how Mydecine is working to unlock the potential of its mycology research.
Growing biotech company becomes latest in a wave of migrations and graduations to NEO
NEO is excited to announce that Mydecine Innovations Group (“Mydecine” or the “Company”), a psychedelics-inspired biotech and life sciences company, is now listed on the NEO Exchange, following a voluntary delisting from the Canadian Securities Exchange. Mydecine is now trading on NEO under the symbol NEO:MYCO.
With a focus on developing and commercializing innovative solutions to improve mental health and enhance vitality, Mydecine is building out a robust R&D pipeline of nature-sourced, psychedelic-assisted therapeutics, novel compounds, therapy protocols, and unique delivery mechanisms.
“Today marks another significant milestone for not only Mydecine as a company, but for our shareholders and future patients, as we commence trading on the NEO Exchange,” remarked Josh Bartch, CEO & Chairman of Mydecine Innovations Group. “Mydecine is a group of entrepreneurs, changemakers, believers, and forward thinkers and we are incredibly excited to share that common thread with the NEO Exchange. We are looking forward to increased liquidity, exposure, transparency and visibility, as well as access to a larger pool of institutional investors, both in Canada and the U.S., alike. This increased access ensures that we will continue to have the necessary resources to achieve each and every one of our goals.”
With today’s launch on the NEO Exchange, Mydecine has become the latest in a wave of corporate migrations and graduations to NEO.
“Mydecine is paving the way for incredible breakthroughs and we are thrilled to support their success as the Company’s listing exchange of choice,” commented Jos Schmitt, President and CEO of NEO. “Psychedelic therapeutic treatments have the potential to offer life-altering relief to millions of people around the world who suffer from mental health and addiction issues. We look forward to providing Mydecine with enhanced visibility and greater access to capital on our tier-one exchange so they can continue the great work they are doing.”
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About NEO Exchange
NEO Exchange is a progressive stock exchange that brings together investors and capital raisers within a fair, efficient, and service-oriented environment. Fully operational since June 2015, the NEO Exchange puts investors first and provides access to trading all Canadian-listed securities on a level playing field. The NEO Exchange lists non-venture companies and investment products seeking a stock exchange that enables investor trust, quality liquidity, and broad awareness including unfettered access to market data.
Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is an emerging biotech and life sciences company dedicated to developing and commercializing innovative solutions for treating mental health problems and enhancing vitality. The company’s world-renowned medical and scientific advisory board is building out a robust R&D pipeline of nature-sourced psychedelic-assisted therapeutics, novel compounds, therapy protocols, and unique delivery systems. Mydecine has exclusive access to a full cGMP certified pharmaceutical manufacturing facility with the ability to import/export, cultivate, extract/isolate, and analyze active mushroom compounds with full government approval through Health Canada. Mydecine also operates out of a state-of-the-art mycology lab in Denver, CO, USA to focus on genetic research for scaling commercial cultivation of rare (non-psychedelic) medicinal mushrooms. Watch the Mydecine corporate video, here.
Mydecine Innovations Group Inc. (CSE:MYCO) (OTC:MYCOF) (FRA:0NFA) Continues to Advance Research & Development Initiatives in the Field of Natural Medicines
Prior to his monumental comeback at the age of 54, former World Heavyweight Boxing Champion Mike Tyson was delivered a message from a frog.
More precisely, he received the message from a psychedelic sourced from the venomous Colorado River Toad, also known as the Sonoran Desert Toad, known as 5-MeO-DMT (aka “5-MeO” or “frog venom”).
“I took the [5-MeO-DMT] and the medicine told me to get into shape,” Tyson said to USA Today.[1] “It really blew my mind. It told me to come back and start getting in shape.”
With the help of the psychedelic, Tyson lost more than 100 pounds for a major exhibition bout against Roy Jones Jr.—his first fight in 15 years.
Said to be more transcendent and less visual than its plant-based cousin DMT, 5-MeO-DMT can be a stronger experience for some.
Most 5-MeO trips are kept to under an hour, and require far smaller dose sizes than other psychedelics.
But even more impressive is the fast-acting psychedelic’s potential, which researchers at Johns Hopkins have discovered can bring about improvements in depression and anxiety.[2]
The potential for psychedelics to treat mental health issues is truly on the precipice of a major breakout—especially as acceptance of this once taboo form of treatment begins to make its way into mainstream medicine conversations.
Tyson is not alone, being among elite athletes who have looked to psychedelics to turn their life around.
Former Los Angeles Lakers star Lamar Odom successfully used the psychedelic drugs ketamine and ibogaine to combat his drug addiction[3]—crediting the drugs with saving his life.
There are other success stories, including those of NHL Enforcers Riley Cote[4] and Daniel Carcillo,[5] former NFL player Kerry Rhodes,[6] and former UFC MMA Fighters Ian McCall[7] and Dean Lister,[8] utilizing previously taboo treatments such as ayahuasca, ketamine, ibogaine, psilocybin, MDMA, and now 5-MeO-DMT.
Now these treatments are shifting from anecdotal to potential alternative medicinal reality, with the advent of clinical trials being advanced by some of the world’s top psychedelic and mental health professionals, including doctors, scientists, and molecular researchers.
Some analysts are projecting the psychedelics medicine industry to reach $6.85 billion by 2027.[9] As psychedelic companies gain acceptance within the investment community, there is an opportunity to review these companies in a new light.
Recently, a new psychedelics ETF began trading in January, and others are emerging to meet the demand, with two surpassing the US$1 billion market cap threshold.
Highlighted within this group of psychedelic companies is one company underpinned by thought leaders in medicine and science, warranting further due diligence and review: Mydecine Innovations Group Inc. (CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA).
The company recently announced and closed a bought deal financing of C$17.25 million, announced uplisting to the NASDAQ, and was just included in the inaugural psychedelics-inspired ETF.
With several clinical trials announced in 2020 and early 2021, including involvement with the first lab-based study co-sponsored by the National Institute for Health Research at Imperial College of London, and a Phase 2A clinical study on PTSD in veterans, EMS, and front-line workers, Mydecine continues to approach research and development with cautious optimism as their programs develop.
7 Reasons Why We’re Watching Mydecine Innovations Group Inc. (CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA)
World-Renowned Medical and Scientific Advisory is building out a robust R&D pipeline of nature-sourced psychedelic-assisted therapeutics, novel compounds, therapy protocols, and unique delivery systems.
Exclusive Access to a Full cGMP Certified Pharmaceutical Manufacturing Facility with the ability to import/export, cultivate, extract/isolate, and analyze active mushroom compounds with full government approval through Health Canada.
Operates Out of a State-of-the-Art Mycology Lab in Denver, CO to focus on genetic research for scaling commercial cultivation of rare (non-psychedelic) medicinal mushrooms
Seven Patent Pending Applications That Represent Thousands of Inventions with multiple layers of protection on the company’s proprietary medical development pipeline.
Proprietary Digital Health Platform, Mindleap, allows Mydecine to generate revenue in the fast-growing US$41.4 billion telemedicine market
Numerous Clinical Trials are currently underway, including a Phase 2A clinical trial on PTSD in Veterans, EMS, and Front Line Workers, a First-of-its-Kind Microdose Study, and Preclinical Animal Work for a Late-State Addiction Study aiming at a Mechanistic Understanding of Psilocybin.
Numerous Novel Next Generation Drugs Under Development:Mydecine is currently developing numerous novel next generation drugs for the treatment of various indications to improve upon the first generation of psychedelic medicines
Combatting the Mental Health Crisis with Psychedelics
COVID-19 is taking its toll on all of us, including rising deaths of despair[10] and an urgent mental health crisis among health workers.[11]
A recent study that screened 402 survivors of COVID-19 found that 55% presented a clinical score for at least one mental disorder, including anxiety (42%), insomnia (40%), depression (31%), PTSD (28%), and OCD (20%).[12]
Anxiety disorders are the most common mental illness in the US, affecting 40 million adults—or 18.1% of the population every year.[13]
Sadly, only 36.9% of those suffering receive treatment, and MORE THAN HALF of people who take antidepressants never get relief.[14]
In cases of Veterans with PTSD, several patients are put on SSRIs, however, only 20-30% of patients achieve complete remission.[15]
SOMETHING needs to change.
Thankfully, we’re witnessing what’s being deemed a “Paradigm Shift in Psychiatric Research and Development.”[16]
That paradigm shift is coming from PSYCHEDELICS.
Now, we’re seeing mainstream coverage being given to the novel mental health approach on 60 Minutes,[17]Forbes,[18]Fox Business,[19]NPR,[20] and Today.[21]
A new wave of mental health sufferers are turning towards small doses of psychedelics, known as “micro-dosing”, to cope with depression and anxiety,[22] or even to achieve higher levels of concentration and creativity,[23] as experts are saying that “legalization is inevitable” for treatments involving psilocybin and other psychedelic treatments.
Mydecine Innovations Group Inc. (CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA) is establishing psychedelic-based therapies, and addressing the unmet needs of high-risk constituents.[24]
The concept is to assist those who have been failed by the current regime of SSRIs and other established antidepressants.
Mydecine’s(CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA) ongoing research to date includes clinicals using psilocybin therapy for PTSD[25] (which has been featured in FORBES[26]), a clinical trial initiative with leading European Research Institute Leiden University Medical Center of the Netherlands,[27] and the first lab-based study of established microdosers at Macquarie University in Australia.[28]
An Evolving Industry Gaining Traction
While therapists are looking at innovative therapies to treat patients, the investment communities within Wall Street and Silicon Valley are also investigating new ways to approach the psychedelic sector. [29]
Naysayers of whether this type of “new medicine” could ever get mainstream acceptance were silenced, when Compass Pathways (backed by ATAI Life Sciences AG), received FDA breakthrough therapy designation on a psilocybin treatment, perhaps better known as the active medical ingredient in magic mushrooms.[30]
ATAI has raised more than US$100 million from major investors such as PayPal co-founder Peter Thiel—and later this year, they are expected to go public at a valuation of US$1-2 billion.[31]
Mydecine continues to expand its technical platforms and outreach with its available and downloadable app: MindLeap.
Through its proprietary Mindleap platform, Mydecine is also giving practitioners the ability to aid their patients better through telehealth abilities and an AI-powered progress monitoring program.
Mindleap is an after-care smart app platform that not only connects patients with their therapists, but also can significantly improve upon monitoring progress, provide follow-up treatment, and give patients other beneficial activities such as meditation, breathing work, and yoga instruction.
Mindleap currently has over 60 specialists with thousands of downloads to date, and is available on both iOS and Android devices.
Comparing Mental Health Psychedelic Stocks
At the end of 2020, the first-ever Psychedelics ETF was announced, which includes 17 companies in the US and Canada, and began trading on January 26, 2021, under the ticker PSYK on the NEO exchange. Announced among and included in that group of 17 was Mydecine Innovations Group Inc. (CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA).
Let’s take a look at some of the other Big Pharma/Mental Health Medicine Stocks.
*Market cap and share price taken from Yahoo Finance on March 9, 2021
As you can see, Mydecine(CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA) is already far along in the licensing process when compared to its peers.
Economic Advantages from Mushroom Research
Out of all of Mydecine’s advantages in the field of developing new medicines, perhaps its largest is its relationship with the University of Alberta, which holds an 11-year-old aged Schedule I license to research, develop, and produce a number of unique APIs (Active Pharmaceutical Ingredients) from their naturally-sourced cGMP psychedelic extracts.
Through this partnership, Mydecine (CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA) has established the World’s First Natural-Sourced cGMP Psilocybin supply for Global Research, Sales, and Distribution.[35]
Currently, scientists are paying $7,000 to $10,000 per gram[36] for synthetic mushroom ingredients—whereas MYCO can legally derive and produce the real organic version of the same ingredients for significantly lower than what is currently available.
Mydecine’s Upcoming Timeline
Mydecine’s Thought Leadership
Mydecine(CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA) has assembled a talented team of thought leaders, whose accomplishments include:
100+ published peer-reviewed studies/papers
World-class team coming from Pfizer, Novartis, Yale, Imperial College, and Canadian, US, and EU Militaries
Proven medical development and approval experience
30+ years of combined psychedelic industry experience
Joshua Bartch, Director, CEO & Co-Founder Bartch’s entrepreneurial career took off in 2009 when he co-founded AudioTranscriptionist.com and founded the Denver-based dispensary, Doctors Orders. Following these ventures, Mr. Bartch founded a boutique investment firm that operated throughout the US and Canadian markets. In 2014, Bartch co-founded Cannabase.io, the USA’s most significant legal and sophisticated pot wholesale platform. In 2015, Cannabase.io was acquired by Helix TCS.
Damon Michaels, Director, COO & Co-Founder Prior to joining MIG, Michaels was consulting for various hemp businesses through his company, Emerald Baron. Before that, he served as GM for the leading multi-platform cannabinoid research and technology firm based in Colorado called ebbu, which was acquired by Canopy Growth for CA$429 million in November 2018. Michaels developed a national snowboard brand with his team, was one of four entrepreneurs who created Colorado’s first-ever glass recycling company, and was on the business development team for a Google Ventures Company.
Robert Roscow, MA – CSO & Co-Founder With expertise in genomics, evolution, and molecular biology, Roscow has previously worked at both Canopy Growth and ebbu, where he ran the genetics divisions. He has filed multiple patents and holds numerous publications under his belt, including Nature and Rolling Stone.
Professor Eric Vermetten MD, Ph.D. Colonel, an internationally recognized leader in the treatment of PTSD and other mental disorders and an active Colonel of the Dutch military. He is also professor of Medical-Biological and Psychiatric Aspects of Psychotrauma, LUMC/University of Leiden. The chair was established by Arq Psychotrauma Research and the Dutch Ministry of Defense. Eric Vermetten is an active clinical psychiatrist at the MGGZ in Utrecht (Military Mental Health care). From 1991 he has been linked to several universities as a researcher, including Stanford University, Yale University, and Emory University.
Dr. Vermetten has published over 300 articles and book chapters on topics ranging from large longitudinal studies following soldiers’ deployments to innovative approaches to treatment. He continues to be a leader within the international psych traumatology community within NATO and beyond.
Dr. Rakesh Jetly, OMM, CD, MD, FRCPC is currently the Head of the Centre of Excellence on Mental Health in Ottawa, Ontario, and an associate professor of psychiatry at Dalhousie University, and the University of Ottawa. He has published numerous articles in professional journals and presents nationally and internationally on such topics as post-traumatic stress disorder and operational psychiatry.
Carl Castro is the research director for the USC Center for Innovation and Research on Veterans and Military Families. Castro has authored more than 150 scientific articles and reports in numerous areas and currently serves as chair of a NATO research group on military mental health training. He serves as an advisor for several Department of Defense research panels focused on psychological health.
7 Investment Highlights of Mydecine Innovations Group Inc. (CSE:MYCO) (OTCQB:MYCOF) (FRA: 0NFA)
Management, research teams, partners (military, scientists, researchers) and one of the original senior marketing executives that launched Red Bull in the US
Substances Dealer’s Licenses from Health Canada that allow Mydecine (CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA) the ability to cultivate, import, export, extract, and commercialize psilocybin and other functional mushroom products.
Technology and Analytics from the Mindleap platform that’s connected to clinics across the globe, providing TONS of data that’s privacy protected, and can improve upon the AI capabilities of this state-of-the-art telemedicine service.
Equipped for industry leading research through 7,500 sq ft Colorado Lab
Access to Top 15 Global Research through the University of Alberta.
Low-cost cultivation that’s capable of deriving APIs from mushrooms at a cost of pennies per gram when scientists are currently paying $7,000-$10,000 per gram for synthetically derived ingredients, giving HUGE leverage to complete clinical studies.
First-of-its-Kind clinical trials (featured in Forbes), with a current pipeline of 8 studies lined up through 2021, through 7 different respected research institutions.
With recent landmark progress in legalization efforts around the world, it’s clear we are in a psychedelic renaissance. In its wake has come a wave of innovation and the emergence of new-age pioneers in the space. Mydecine Innovations Group (CSE:MYCO) (OTC:MYCOF) (FSE:0NFA) is an example of a company that is far ahead of the curve. Based out of Denver, Mydecine has established itself as a leader in the emerging field of psychedelic-assisted treatments for mental health.
Earlier this week, Director and CEO Josh Bartch sat down with the Dales Report to discuss how the past 12 months have been monumental to both the psychedelics industry and Mydecine.
What Makes Mydecine Unique?
There are a few key differentiators that place Mydecine in a league of its own. Whether it’s their R&D or the actual production of drugs, the company has a rare combination of capabilities. Josh explains these in more detail, “One thing about Mydecine that’s incredibly unique is that we’re fully vertically integrated, So as it pertains to psychedelic assisted psychotherapy, we really have an A-Z capability.” This comprehensive pipeline gives Mydecine a unique advantage when it comes to clinical trials. With a full set of operations in-house Mydecine can rapidly innovate.
Evidently, Mydecine has taken full advantage of its integrated supply chain with a global clinical trial infrastructure with sites approved throughout Canada, Europe and the United States.
Despite Mydecine’s vast array of capabilities, the company’s mission can be broken down into a few defining elements. As Josh lays it out, “Mydecine Innovations Group really now has become a global company with really three main focuses: One is IP and R&D and our drug development pipeline is in that branch. Two is our clinical trial development and three is going to be our technology platform MindLeap.”
During the last few months, the clinical pipeline has been in full swing with Mydecine announcing an upcoming phase 2A trial which will center around exploring psilocybin-assisted therapy for the treatment of PTSD in veterans and emergency personnel. In a global display of research capability, the clinical trials will take place across 3 continents with the goal of establishing the safety and efficacy of psychedelic administered psychotherapy in a supervised setting.
On the technological side, Mydecine has been continuing development of the “Mindleap” platform which will allow them to administer psychotherapy protocols remotely. With a growing number of people avoiding in person health services at the moment, the mindleap platform is proving to be especially relevant. The company believes this key differentiator will strengthen the connection between patients and healthcare providers.
Josh explains in more detail, “So I think something that’s really important to remember is that this is psychedelic-assisted psychotherapy. Seven-tenths or eight-tenths of the equation are one-on-one psychotherapy meetings between psychotherapists and patients with no substances taken at all… So if we can aggregate with what we’ve been able to do with MindLeap, professionals that have been trained in the psychotherapy protocol under one roof and give patients access to be able to take the seven or eight-tenths of the equation, remotely, obvious vastly increases the scalability of the treatment.”
Mydecine encompasses the new era of medicine, making it a one stop shop for psychedelic treatment and innovation. To watch for in 2021: Mindleap recently announced a 2.0 coming to the platform to deliver ancillary services that are complementary to the psychotherapy. In the coming months, Mydecine has its sights set on uplisting to the NEO and Nasdaq exchanges.
Company Appoints Former Novartis Norway CEO as President of European Operations, and Partners with Dr. David Erritzoe in the set up of a novel collaborative psychopharmacology/psychedelic research clinic between Imperial College London and a major mental health NHS Trust in London
DENVER, March 16, 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 therapeutic medicine for mainstream use, announced that it has appointed Michel Rudolphie, former CEO and President of Make-A-Wish International and former Novartis Norway CEO, as President of the Company’s European Operations. In addition to adding new leadership, the Company also announces that it has partnered with Principal Investigator Dr. David Erritzoe at Imperial College London (ICL) to conduct leading research in the expanding field of psychedelics, as well as the creation of a novel collaborative psychopharmacology/psychedelic research clinic between ICL and a major mental health NHS Trust in London.
In an effort to further develop the Company’s international footprint and expand upon its existing clinical research efforts, Michel has been appointed to develop and lead Mydecine’s strategy, business development and comprehensive success across Europe. In addition, he will oversee Mydecine’s European clinical research initiatives and partnerships including its current Phase 2a clinical trials of psilocybin-assisted psychotherapy to treat chronic PTSD in veterans and EMS personnel at Leiden University Medical Centre in the Netherlands.
Michel, a Dutch citizen with a MSc and MBA in Healthcare Management and Policy from Erasmus University in Rotterdam, has an impressive career record in the healthcare industry, with a succession of leadership positions at Novartis for 14 years, including four years serving as CEO of Novartis Norway.
“We have significant plans in 2021 to capitalize on the international renaissance for psychedelics-based therapies amongst the medical community and researchers. European universities and other research organizations, particularly those in the U.K. and Netherlands, have shown great enthusiasm and determination to better understand the science of how these drugs work and how they can be utilized to help people suffering from PTSD,” said Josh Bartch, CEO of Mydecine. “In our conversations with Michel, it quickly became clear that his extensive experience in the international pharmaceutical space coupled with his knowledge of developing and executing partnerships with both non-profit and for-profit organizations would be a great asset to our growth. His impressive personal qualifications and as importantly, his demonstrated passion and commitment to advocating for enhanced PTSD treatment for uninformed individuals, perfectly aligns with the vision and mission of Mydecine and we are thrilled to add him to our senior management team.”
In 2018, Michel joined Make-A-Wish International as CEO and President and was responsible for moving the international headquarters from Phoenix, Arizona to the Netherlands, in addition to assembling a new team and developing the foundation’s internal and external strategy. Prior to joining Make-A-Wish, he served as the CEO and President of the Dutch Cancer Society, the largest health charity in the Netherlands. He has also previously served in a number of senior management roles within the healthcare industry including as CEO of Bioness and Vice President of European Operations for Nucletron, a global medical device company specializing in innovative products used for cancer treatment.
“Throughout my career, I have leveraged my experiences in the healthcare sector to advance both start up and mature companies through their various stages of development,” said Michel. “I’m very excited to join the Mydecine team, which has outstanding expertise in new approaches to innovative solutions for treating mental health and enhancing vitality. Having built a culture of scientific excellence, and building a global network among leading research collaborators, Mydecine is poised for its next evolution in meeting compelling patient needs in mental illness and mental disorder.”
With regard to Mydecine’s work with ICL and Dr. Erritzoe, the research to be undertaken in the new NHS-based research clinic is set out to cover:
Experimental psychopharmacology research in healthy populations and in addictions, obsessive compulsive disorder, eating disorders, and affective disorders;
Proof of concept studies and clinical trials testing efficacy, safety and mechanisms using a range of doses from micro- to macro-doses of psychedelics and associated compounds;
Use of multimodal human brain imaging to investigate mechanisms behind the actions of classic psychedelics and ketamine.
Part of Dr. Erritzoe’s current work includes studies that evaluate the science and efficacy of different doses of psychedelics in order to uncover mechanisms of actions and effects on brain plasticity, and cognitive and emotional processes. “The research of Dr. Erritzoe, who has published extensively on the science of psychedelics and microdosing, is critical to advancing the scientific efficacy of psychedelic medicines, and the results of studies from his team will be of critical importance as we develop the drug design and protocols for future controlled studies led by Mydecine,” said Mr. Bartch. “We are honored to be working with the Centre for Psychedelic Research and the new NHS-based research clinic as they progress and collect this important information to ensure safe use of psychedelics with the goal of producing the best possible outcomes for patients.”
Dr. Erritzoe is a Clinical Senior Lecturer in Psychiatry at Imperial College London. Alongside his clinical work in medicine/psychiatry, he conducts psychopharmacological research, using brain-imaging techniques such as PET and MRI. He was trained in PET imaging at Columbia University in New York and later undertook a PhD at University Hospital Rigshospitalet in Copenhagen. Since 2009 he has been involved in post-doc imaging research in the neurobiology of addictions and major depression at Imperial, and, together with Professor David Nutt and Dr. Carhart-Harris, he investigates mechanisms and therapeutic potential of MDMA and classic psychedelics.
“It is a very interesting time for psychedelic science and we are privileged and thankful to have received support to start an exciting new research clinic based at St Charles Hospital in CNWL Mental Health NHS Foundation Trust that will allow us to expand our clinical psychopharmacological research conducted from the Centre for Psychedelic Research at Imperial,” said Dr. Erritzoe. “Mydecine supports the expansion of ongoing work in the Centre at ICL and their contributions and enthusiasm for furthering this important work.”
About Mydecine Innovations Group
Mydecine Innovations Group™ (CSE: MYCO) (OTC:MYCOF) (FSE:0NFA) is an emerging biotech and life sciences company dedicated to developing and commercializing innovative solutions for treating mental health problems and enhancing vitality. The company’s world-renowned medical and scientific advisory board is building out a robust R&D pipeline of nature-sourced psychedelic-assisted therapeutics, novel compounds, therapy protocols, and unique delivery systems. Mydecine has exclusive access to a full cGMP certified pharmaceutical manufacturing facility with the ability to import/export, cultivate, extract/isolate, and analyze active mushroom compounds with full government approval through Health Canada. Mydecine also operates out of a state-of-the-art mycology lab in Denver, CO to focus on genetic research for scaling commercial cultivation of rare (non-psychedelic) medicinal mushrooms.
At the heart of Mydecine’s core philosophy is that psychedelic-assisted psychotherapy will continue to gain acceptance in the medical community with many of the world’s best accredited research organizations demonstrating its remarkable clinical effectiveness. Mydecine recognizes the responsibility associated with psychedelic-assisted therapy and will continue to position itself as a long-term leader across the spectrum of clinical trials, research, technology, and global supply. Mydecine has also successfully completed multiple acquisitions since its inception.
For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.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 information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. 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, risks regarding the COVID-19 pandemic, 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.
DENVER – March 10, 2021 — Mydecine Innovations Group (CSE: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine”), is pleased to announce that it has entered into an arrangement agreement dated March 10, 2020 (the “Arrangement Agreement”) with a newly-incorporated wholly-owned subsidiary, (“Spinco”). Under the Arrangement Agreement, Mydecine will transfer its [U.S.] Cannabis Assets (defined below) to SpinCo in accordance with a plan of arrangement pursuant to the Business Corporations Act (British Columbia) (the “Arrangement”), in consideration for approximately 10,000,000 common shares of Spinco (the “Spinco Shares”). The Spinco Shares will then be distributed to Mydecine’s shareholders on a pro rata basis. Upon completion of the Arrangement, Mydecine’s shareholders will own shares in two reporting issuers.
Spinco intends to apply to list its common shares on the Canadian Securities Exchange or the Aequitas Neo Exchange upon completion of the Arrangement.
The assets to be transferred to Spinco under the Arrangement will be all of the shares held by Mydecine in the following companies:
a) 1176392BC Ltd.
b) Alternative Distribution Company, LLC
c) Drink Fresh Water, LLC
d) New Age Farm Washington, LLC
e) Tealief Brands, LLC
f) Relyfe Brands, LLC
g) We are Kured, LLC
h) Trellis Holdings Oregon OP, LLC
(collectively, the “[U.S.] Cannabis Assets”).
Upon completion of the Arrangement, Mydecine’s principal business will focus on the development and commercialization of solutions for treating mental health problems through its psilocybin research and development and it will no longer be involved in the manufacturing or sale of cannabis and CBD products.
The Arrangement is subject to, among other things, the approval of the Supreme Court of British Columbia, the approval by the Mydecine shareholders at a special meeting to be held on a date to be announced in the future (the “Meeting”),regulatory and stock exchange approval and completion the Spinco Financing (as defined below).
Additional details of the Arrangement will be provided in a management information circular that will be mailed to all Mydecine shareholders prior to the Meeting. At the Meeting, shareholders will be asked to vote on a special resolution approving the Arrangement, among other resolutions.
Concurrently with the Arrangement, Spinco shall complete and offering of Spinco Shares for aggregate gross proceeds of a minimum of $2,500,000 and a maximum of $5,000,000 (the “Spinco Financing”). The price per share in connection with the Spinco Financing will be determined by the board of directors of Spinco at a later date.
The Arrangement will be a non-arm’s length transaction. There are no finder’s fee associated with the Arrangement or the Spinco Financing. The Arrangement is expected to close in May 2021.
About Mydecine Innovations Group
Mydecine Innovations Group™ (CSE: MYCO) (OTC:MYCOF) (FSE:0NFA) is an emerging biotech and life sciences company dedicated to developing and commercializing innovative solutions for treating mental health problems and enhancing vitality. The company’s world-renowned medical and scientific advisory board is building out a robust R&D pipeline of nature-sourced psychedelic-assisted therapeutics, novel compounds, therapy protocols, and unique delivery systems. Mydecine has exclusive access to a full cGMP certified pharmaceutical manufacturing facility with the ability to import/export, cultivate, extract/isolate, and analyze active mushroom compounds with full government approval through Health Canada. Mydecine also operates out of a state-of-the-art mycology lab in Denver, CO to focus on genetic research for scaling commercial cultivation of rare (non-psychedelic) medicinal mushrooms.
At the heart of Mydecine’s core philosophy is that psychedelic-assisted psychotherapy will continue to gain acceptance in the medical community with many of the world’s best accredited research organizations demonstrating its remarkable clinical effectiveness. Mydecine recognizes the responsibility associated with psychedelic-assisted therapy and will continue to position itself as along-term leader across the spectrum of clinical trials, research, technology, and global supply. Mydecine has also successfully completed multiple acquisitions since its inception.
Learn more at: https://www.mydecine.com/ and follow us on Facebook, Twitter, and Instagram.
For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.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 information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Forward looking-information in this news release includes, but is not limited to: statements with respect to completion of the Arrangement; benefits of the Arrangement; obtaining Shareholder and final court approval of the Arrangement; the listing of Spinco Shares on a stock exchange and timing thereof; anticipated Meeting date; the timing for mailing of an information circular; and holding the Meeting; completion of the Spinco Financing and timing of closing of the Arrangement. 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, risks regarding the COVD-19 pandemic, 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.
Damon Michaels, chief operating officer of emerging biotech and life sciences company Mydecine sat down with The Dales Report last week to discuss the company’s latest activity.
“We’re dedicated to taking a holistic approach toward making alternative medicine traditional medicine,” Michaels said in the interview.
Mydecine intends to do that by focusing heavily on drug development, as well as developing novel delivery systems. Michaels said the company will soon be conducting clinical trials “for the many safe and effective active and medicinal compounds found within fungi or mushrooms,” while CEO Jason Bartch announced recently that Mydecine is cultivating psilocybin mushrooms to be used in a phase two clinical trial for post-traumatic stress disorder.
Additionally, Michaels said the company is the first to establish a certified CGMP global supply chain for psychedelic medicinal mushrooms, and announced last week that it had completed the first-ever international export of psilocybin mushrooms out of Jamaica.
“We’ve also launched our own digital telehealth app, which is of course dedicated to psychedelic therapy,” Michaels added.
Mydecine currently has a fully diluted market cap of close to $100 million, which happens to be less than other firms with plans for phase two clinical trials.
“Across the market, people keep saying that we’re the most undervalued stock there is in the psychedelic sector,” he said. “I feel like the value that we are currently building on is going to shine through once people really understand what’s going on behind the scenes.”
As far as differentiators go, Michaels emphasized that Mydecine is working to build a company that is strong, reliable, and trustworthy; one focused on “developing things that matter to others versus just targeting short-term monetary gains.”
“We really care about the food, fiber, and medicinal balance that fungi brings to life here on earth, and now it’s a responsibility [to] push for the science-backed education, the medicine and health-conscious products, the markets that really help sustain life,” he said.
Mydecine currently has an exclusive partnership with Applied Pharmaceutical Innovations (hosted out of the University of Alberta) through which it will be conducting research.
Michaels said the partnership is just one of several that have helped to prove out the company’s approach in the psychedelic space.
“When Mydecine was formed and founded, we finally had the vehicle that we needed to plug a lot of our resources in incredible people and networks and different companies, to finally plug them in and to work with them,” he said.
Mydecine’s telehealth app, Mindleap, has been in development for some time and Michaels says it has improved substantially since the company took on the project. He noted that since the company was founded at the start of the Coronavirus pandemic, the team at Mydecine has learned quickly to adapt and overcome.
“As the world moves into the new age of telemedicine, we knew that it was going to be perfect for the ecosystem we’re building here at Mydecine,” Michaels said. The app will provide a way for patients to receive remote therapy following a psychedelic experience. He noted that the app will be used in its clinical trials.
Last June, Mydecine acquired Neuropharm Inc., and transitioned Dr. Rakesh Jetly to become the company’s chief medical officer. Dr. Jetly recently retired from a 31-year-career as the head of psychiatry of the Canadian Armed Forces, something Michaels says fits well with the company’s current focus of PTSD.
Michaels said Jetly’s scientific advisory board is the “dream team” of doctors, professors, and researchers, and the company is looking forward to putting all the pieces together in trials.
“To be able to pair that with the best minds that are going after these types of treatments, I think that we’re really going to be uncovering how to make alternative medicine traditional medicine through these practices.”
Mydecine Innovations Group (CSE:MYCO) (OTCMKTS:MYCOF) CEO Joshua Bartch tells Proactive the Colorado-based emerging biotech and life sciences company is advancing towards a Phase 2 study to treat PTSD with its ‘purified’ psilocybin mushrooms.
Bartch says the group recently produced its first commercial harvest of 20 kilograms of psilocybin mushrooms at a private research and cultivation facility in Jamaica, which was exported into Canada at the University of Alberta.
It’s been an exciting news cycle for Mydecine Innovations (CNSX:MYCO) (OTCMKTS:MYCOF) in 2021, with the company being selected for inclusion in the Horizons Psychedelic ETF, raising capital, completing the first-ever international export of psilocybin mushrooms, and everything in between. This week, TDR sat down with Josh Bartch, Co-Founder & CEO of Mydecine, to put these recent company events in context.
A Diverse Mandate With A Simple Mission Statement
As we’ve recently profiled on The Dales Report, Mydecine Innovations is first and foremost an industry leader in the study of mycology, or the branch of biology concerned with the study of fungi. Although there are many moving parts, the company has a very simple mission statement: to unlock the full potential of fungi in both pharmacological and nutraceutical domains.
In recent times, the company has narrowed their focus along specific segments that will allow it to best maximize and monetize its vast research and technology assets. In the words of Josh Bartch:
“Mydecine Innovations Group really now has become a global company with really three main focuses: One is IP and R&D and our drug development pipeline is in that branch. Two is our clinical trial development and three is going to be our technology platform MindLeap.”
On the clinical side, Mydecine is undertaking an upcoming international Phase 2A study that will focus on psilocybin-assisted psychotherapy to treat chronic PTSD in veterans and EMS personnel. Similar to the Phase 2B psilocybin-assisted trials being conducted by Compass Pathways, Mydecine’s research will take place at various clinical sites across three continents, in an effort to establish the safety and efficacy of psychedelic administered psychotherapy in a supervised setting.
On the technology side, Mydecine boasts its industry-leading psychedelics telemedicine platform named MindLeap. With COVID-inspired lockdown driving global demand for telemedicine products and services to dizzying heights, the company believe its MindLeap technology is a key differentiator that will connect patients to health care providers. Josh Bartch explains to viewers how pivotal a properly functioning portal is to any psychotherapy-assisted program:
So I think something that’s really important to remember is that this is psychedelic-assisted psychotherapy. Seven-tenths or eight-tenths of the equation are one-on-one psychotherapy meetings between psychotherapists and patients with no substances taken at all… So if we can aggregate with what we’ve been able to do with MindLeap, professionals that have been trained in the psychotherapy protocol under one roof and give patients access to be able to take the seven or eight-tenths of the equation, remotely, obvious vastly increases the scalability of the treatment.”
Josh provides much more insight on the inner working of Mydecine’s operating plan. Watch the full interview below:
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