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Mydecine Innovations Group Announces Launch of Mindleap Version 2.0

DENVER, July 13, 2021 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO: 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 is pleased to announce that its subsidiary Mindleap Health (“Mindleap”), is launching the 2.0 version of its virtual health platform on July 30, 2021 (see Mindleap.com), which provides the infrastructure to support the conscious and trustworthy adoption of psychedelics into the broader categories of mental health and inner wellness.

“We are providing a platform that can help transform the lives of millions of people,” said Mindleap Interim CEO & Technical Director William Cook. “Our aim is to bring conscious and trustworthy support for people on their daily mental-health journey while also supporting life-changing healing experiences.”

Mindleap is designed to support users via a number of complementary features, including a media library that contains guided meditations, sound journeys, and educational content about inner wellness and psychedelic medicines. Mindleap’s media content is developed in partnership with world-class researchers and practitioners who study and practice various aspects of psychedelic medicines and treatments, mental health, and neuroscience. Some of the guests featured on Mindleap 2.0 content include leading researchers such as David Erritzoe, MD, Ph.D. from Imperial College of London, John Cline, Ph.D. from Yale, as well as Gregory Wells, PhD, and Marcela Ot’alora G. from MAPS.

Mindleap 2.0 also features a focus on the community that allows users to get to know and learn from mental health specialists via media and written posts. Once users are ready, they can schedule and attend encrypted video support sessions via the platform and receive guidance from psychedelic integration or inner wellness specialists. Users can monitor and log various aspects of their inner wellness via the updated private health journal. Additionally, they have the option to temporarily share their health journal with a specialist during a private video support call, to help specialists develop a better understanding of how they’re doing.

“The platform provides the optimal community space for users to develop trust in and connect with support professionals,” said Nicholas Martin, Mindleap’s Director of Specialists & Community. “Users will be able to connect with integration specialists who have demonstrated experience and training from psychedelic integration training programs.”

Mindleap is also being designed to support patient care and monitoring that supports clinical trials, including those being run by Mindleap’s parent company, Mydecine Innovations Group. Together, Mindleap’s content library, health journal, community platform, video support sessions, and practice management portal make it an advanced bundled solution that is paving the way for the future of mental health.

About Mydecine Innovations Group

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 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.

About Mindleap Health

Mindleap Health Inc., a wholly-owned subsidiary of Mydecine, is a virtual healthcare company that offers technology solutions that allow people to improve their mental health and wellbeing. Mindleap is a virtual health platform that provides our users with inner wellness resources to assist them in their daily mental-health journey. Mindleap features a community of professionals, a private health journal, and an ever-expanding content library that includes meditations and psychoeducation materials from experts in mental health. Mindleap provides the space for users to videoconference with professionals who can support them in psychedelic integration, as well as their inner wellness journeys more broadly. The Mindleap infrastructure is designed to foster the conscious and trustworthy adoption of psychedelics into a widely accepted approach to mental health and inner wellness.

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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.

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.

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Psychedelic Finance Interview with Damon Michaels, Director, COO, & Co-Founder

Damon Michaels is the Chief Operations Officer of Mydecine Innovations Group. Prior to joining MIG, Mr. 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. In November of 2018, ebbu was acquired for CAD $429m by Canopy Growth for being the cutting edge leader in cannabinoid science. Over the last decade, Mr. Michaels has been in leading roles with multiple large brands throughout the cannabis vertical in Colorado and California. Outside of the cannabis industry, he 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.

 

What made you personally want to get involved in psychedelics?

Ever been to a really good awe-inspiring magic show that left you walking out of the auditorium questioning reality? I always knew that there was more to life than what meets the eye, but sometimes there’s more than seeing with believing. After you’ve undergone a real psychedelic experience, it kills your ego. You establish greater empathy for others, and come to the realization that all things are connected. You also realize that there is so much more to life, consciousness, and healing, than we ever thought possible and I knew I wanted to find a way to one day take it mainstream to help awaken and heal others.

Why is Mydecine focused on building for both psychedelic medicines and psychedelic assisted therapies?

Our dedicated clinical research team has been studying psychedelic therapeutics for decades. We strongly believe there is a two-part equation to help solve the mental and social disorders that people may be suffering from prior to their psychedelic therapy. Simply think of consuming psilocybin, the psychedelic precursor chemical found in “magic mushrooms”, as a reset switch for your brain to help physically get the brain back on track. After the psychedelic experience, the back-end therapy is designed to walk you through the second stage of the healing process to make sure you don’t fall back into old habits or routines that could retrigger the original disorder. Mydecine is initially targeting PTSD and combating smoking addiction with a two-stage combination of medicine and therapy.

How did you develop your state-of-the-art mycology laboratory?

After we scouted multiple locations around the Denver area, we landed on the perfect environment for our mycology lab we call MYCOM (Mydecine Center of Mycology), which is also our US headquarters. It was once an FDA approved lab for probiotic research, so it had a great built-in layout for what we needed. After shaking hands with the landlord and locking down the lease, we brought in our elite group of staff who have extensive backgrounds in mycology research, genetics, and chemical analytics, to help us outfit the lab with our own design and equipment needed to conduct our ongoing studies around non-psychedelic medicinal functional mushrooms. Additionally, we have also started the process to get this lab under a DEA license to research and analyze psychedelic mushrooms as well.

What types of research are you currently focused on?

We are an emerging research driven biotech company, developing a vast IP portfolio, so we’re dedicated to all types of necessary research. Our company’s primary R&D focuses around our novel drug discovery and design of entheogenic, empathogenic, and nootropic compounds, therapeutic protocols, clinical trials, genetic experiments, artificial intelligence, patent design, and chemical analysis from fungal sources.

What kind of difficulties do you face in balancing international regulations and working within regulatory frameworks in the US, Canada, and Jamaica? How have you been able to legally export psilocybin and how will that evolve moving forward?

It’s always a balancing act to develop systems and operate between multiple regulated government bodies, but that is partly what our expert team of attorneys are on retainer for. They make sure that we do everything by-the-book in the eyes of the law. Months ago, we successfully and legally completed the first-ever international shipment of psilocybin containing mushrooms from Jamaica to Canada. This was facilitated under a Health Canada Schedule I Dealer’s License that is possessed by our R&D lab in Alberta. Currently, we are only supporting the feedstock of our own drug design and clinical trials. However, as things evolve, we hope to be able to commercially supply to a regulated market once we get FDA approval. After that, we can open up the doors further to collaboration and begin exporting to third party clinical trials, research groups, government entities and other licensed facilities that may be in need of our top tier product supply on a global scale.

How do you manage the different areas of focus at Mydecine and cohesively bring them all together?

Very carefully while putting work in many long hours of the day! Honestly, we probably couldn’t have pulled it off the way we did and as fast as we did it, if we weren’t a remotely structured company with access to modern day technologies that we all knowingly take for granted. Mydecine was founded at the height of Covid-19 in March of 2020, so we were forced to build the company remotely and put very strong telecommunication skills in place. Being mostly remote has opened up the doors much wider to human capital which allowed us to handpick the best team of constituents from around the world. If we could only hire locally from a designated city, it’s doubtful that we would have been able to put together the team we did. Everyone on the team jives really well together and are all hardworking passionate individuals that are as loyal as they come. This helps quite a lot when we’re all focused and working together to accomplish common goals.

How will your recent partnership with Applied Pharmaceutical Innovation allow you to further develop your novel compounds?

API’s exclusive partnership with us gives Mydecine carte blanche access to a research facility worth over $100M in assets along with access to an incredible group of world-class scientists. This has helped Mydecine to further our research and expand at a faster pace than we ever could have if we tried to build out a CGMP pharmaceutical grade research lab on our own. The lab has all of the technical, fundamental, and experimental capabilities needed to legally import, extract, process, research, analyze, produce, manufacture, sell, distribute, and export psychedelic Schedule I substances such as psilocybin, psilocin, and MDMA. The lab at API is the ultimate pharmaceutical environment we needed to discover and characterize countless molecules found in mushrooms and to also have the ability to take our novel drugs from pre-clinical trials all the way through to phase 4 clinical studies.

What is the biggest misconception that people have about psychedelics?

I can at least speak for psilocybin/psilocin, because that is what we’re primarily focused on. I think the biggest misconception is that these compounds are harmful, toxic, unsafe for use, and have zero medicinal value. This is completely untrue as psilocybin alone is safer than caffeine, and there is zero risk of dependency and abuse. There is ample historical data from many of the world’s top universities to show that psilocybin/psilocin have plenty of legitimate medical uses.

How did Mydecine choose what areas to focus on for clinical trials and why did you ultimately land on PTSD and smoking cessation?

From the get-go, we focused our efforts on PTSD and eventually added smoking cessation, because they are both indications that we personally hold close to our hearts. Unfortunately, many of our team members have had to deal with the traumatic repercussions of a friend, colleague, or loved one taking their own life as a result of suffering from severe PTSD. Understanding the potential healing power of psychedelic medicine and wanting to target this indication is what prompted Mydecine to fully acquire NeuroPharm, a dedicated psychedelic industry entity geared towards PTSD relief in veterans and frontline workers using psychedelic-assisted psychotherapy. One of the amazing team members that came along with the acquisition is Dr. Rakesh Jetly (Mydecine’s Chief Medical Officer) who we fully admire and respect from what he’s accomplished in his career already. As of February of this year, Dr. Jetly has fully retired from a 31-year career with the Canadian Armed Forces with the last decade holding the position as Head of Psychiatry. He knows all too well the devastating effects of PTSD more than anyone we know and knew there had to be a better solution than what currently exists within the limited options of Western medicine. This led Dr. Jetly to spend many years studying psychedelic medicine and it’s safe and effective uses with treatment resistant patients. Neuropharm’s clinical trial developments and its patients are now fully under Mydecine’s care and we couldn’t be more thankful to be working alongside Dr. Jetly as we continue to expand the efforts he and his team initially started. Currently, there are no prescribed medications in the market specifically designed for PTSD.

As for smoking cessation, we know based on historical data, which recently has been developed out of Johns Hopkins University, led by Dr. Matthew Johnson (who we’re huge fans of), showed major promise to help people kill their addiction to deadly nicotine. There is over a 60% success rate using psychedelic therapy for smoking cessation. Other products that are currently on the market have a much lower rate. CHANTIX has been the leading prescribed drug for nicotine addiction, but with only a 20% one-year success rate. CHANTIX was also just recalled a few weeks ago due to the discovery of carcinogens found within it.

What trend do you think is emerging in the world of psychedelics and what impact do you see that having?

One trend that is catching on quickly in the medical field and throughout the media, is that we are all starting to see an increasing number of people who are accepting and willing to try psychedelic-assisted psychotherapy as more education and research is revealed. For mental health treatment, it’s safe, effective, what more could you ask for?. It finally gives people an alternative rather than having to take a pill the rest of their life that may do more harm than good. Kind of a no-brainer (pun intended)! Once these novel drugs go through the traditional path of FDA approval (hoping to achieve breakthrough status) and eventually get approval, doctors can prescribe this medicine to their patients and we will see a new wave of healing on a global scale that we’ve never seen before in modern history. It’s time to normalize psychedelic medicine and therapy and open up mainstream accessibility.

Can you tell us more about Mydecine’s digital health platform?

Mydecine saw the huge upside opportunity with Mindleap Health, which is why we decided to acquire it early on. With everything going remote due to Covid, it couldn’t have been better timing to resurrect Mindleap and give users the convenient ability to connect with a mental health specialist wherever they are in the world at any time of the day. Mindleap is very unique as it is the first mental health application to bring psychedelic treatment and inner wellness together. We’re very excited for Mindleap right now, because 2.0 is about to launch on iOS and Android platforms this month, which will give the user a lot more options to reach their mental health success by adding other integrations into the Mindleap platform (i.e. yoga, breathwork, nutrition, etc.). Mindleap also collects data from wearables such as watches to help the specialists understand the user more than ever before. This in turn helps the specialists develop the best path for the user to achieve their mental health goals. All data is secure and is managed strictly by the user, Mindleap does not sell any of the data, and the platform itself is HIPAA compliant. Mindleap will also be a great medical tool for Mydecine and other research organizations to better manage clinical trials in regards to psychedelic integration therapy.

Who is someone doing important work in the world of psychedelics? Who you think more people should be aware of and what companies do you see that are also on the path to succeed?

There is absolutely no way I can just narrow that down to one person. First off, I want to start off by saying our amazing staff and Mydecine’s Scientific Advisory Board Members are absolute rock stars. Outside of our direct team, a handful of others I commend in psychedelics are people like Dr. Matthew Johnson – who I mentioned earlier, Rick Doblin, David Nichols, Dennis McKenna, Rachel Yehuda, Daniel Carcillo and Paul Stamets just to name a few, but there are plenty of others. The leading industry companies that I personally see doing real work out there next to Mydecine are (in no particular order): MAPS; Cybin; Entheotech; Numinus; MagicMed; CaamTech; Gilgamesh; The Beckly Foundation. I’m sure there are other companies doing significant work as well, but these are the companies that come to mind.

Overall, we truly hope this industry breaks the mold of classic dog-eat-dog scenarios of other major industries and finally finds a way to create a strong network of collaboration, so that we all rise together in this renaissance.

 

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Always do your own research and make your own investment decisions. This is not a solicitation to purchase or sell securities. Psychedelic Finance is not a registered investment advisor and does not purport to provide investment advice, whether implied or otherwise. Psychedelic Finance does not independently verify the accuracy or the truth of the statements or representations made by issuers. This message is meant for information and educational purposes only and Psychedelic Finance does not intend for this information to be used to inform an investment decision.

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Mydecine CEO Josh Bartch Speaks on Psilocybin and Smoking Cessation

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We’ve spoken with Mydecine Innovation Group (NEO: MYCO) (OTCMKTS: MYCOF) about the exciting possibilities of using psychedelics to treat PTSD and other disorders of addiction. Today, Josh Bartch, co-founder and CEO discusses the possibility of Mydecine using the compounds MYCO-001 and 004 to enable smoking cessation.

Here’s some highlights from the interview.

Roth Capital gives Mydecine a ‘buy’ rating and $3/share price target

For investors who may have missed the news, RCP initiated coverage with a “Buy” Rating and C$3.00 price target. That’s a 916.94% premium to Mydecine’s closing price of $0.295/share before market open on June 22. That’s a projection the company rises 916% higher than its current trading price within the next twelve months.

Mydecine advantage: other smoking cessation drugs in the market dangerous and ineffective

Bartch says that even if you look at an analogous product of MYCO-001, the efficacy data shows rates “astronomically higher” than other anti-smoking drugs on the market. Most drugs meant for smoking cessation, he says, have efficacy rates in the single digits. Psilocybin has shown efficacy rates as high as 85% in a 12 month abstinence study.

Also to their detriment, the currently-available smoking cessation pharmaceuticals come with a long list of side effects at the best of times, including depression, suicidal tendencies, and weight gain. Chantix, one of the current top drugs available for smoking cessation, was also recently voluntarily recalled by Pfizer for containing elevated levels of a cancer-causing substance.

The safety of psilocybin, on the other hand, has been proven. Compared to the pharmaceuticals, it’s also curative; smoking cessation drugs currently commercially available have to be taken over a longer course, or in some cases, even in perpetuity, opposed to a single macro-dose of psilocybin.

Mydecine could still be undervalued, says Bartch

Bartch says that everyone at Mydecine was extremely pleased with the RCP report. Part of RCP’s valuation of Mydecine was based on claiming only half a percent of the total smoking cessation market, which would still give the drug approximately $2.5bn in sales by 2031 – not a small number at all.

RCP’s valuation was also based on MYCO-001 alone. 001 is Mydecine’s purified single molecule of psilocybin, and analogous to a synthetic form except the company retains freedom to operate since there are no patent claims to infringe upon, says Bartch.

MYCO-004 is templated upon 001 and is a refined product. It provides the same experience, but is condensed to about a 2 hour delivery time as opposed to 4-8 hours with pure psilocybin. This makes the molecule much more scalable and applicable to a therapy setting, he adds.

Smoking cessation a huge possible market for Mydecine

Bartch says that to date Chantix has been producing $1.2bn globally in revenue, $900m in the US alone. A smoking cessation drug would only need a very small part of a market pie that’s predicted to be $60bn 2026 to be a huge success.

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The Next Step for Legal Mushrooms—Losing the Trip

The latest push in the burgeoning psychedelic industry is to lose the whole pesky “psychedelic” element, and it has a surprise backer in the late Bob Marley.

The shroom industry is calling them “functional mushrooms”—a tip of the spear marketing move attempting to legitimize the image of fungi as medicine, without promising far-out, potentially transformative trips that most people associate with psychedelics.

Just what are “functional mushrooms”? They’re basically legal fungi supplements boasting various health benefits, none of which are hallucinatory, mind-expanding, or especially psychedelic in nature.

But Silo Wellness, a Canadian-based company that currently offers a range of guided magic mushroom retreats in the coastal resort mecca of Montego Bay, Jamaica (where many psychedelic drugs are legal), is hoping these shroomy supplements can help capture the emerging psychedelic market, valued at roughly US$4.5 billion as of 2020. And they’re doing this with celebrity brand recognition.

Silo has partnered with the family of the late reggae pioneer Bob Marley to launch Marley One, a functional mushroom line—tinctures incorporating mushrooms such as lion’s mane, chaga, and reishi—while eyeing an eventual, legal, psychedelic product. As Silo CEO Douglas K. Gordon describes it, in terms consistent with Marley’s own Rastafarian beliefs, “It goes more to plant medicine; it goes more to mindfulness. It goes more to embracing the fact that the Earth has its own capacity for healing.”

Rita Marley (who prefers to be addressed as Mrs. Marley), widow of the late Bob, echoes these sentiments in a statement. “Bob and I followed a strict natural diet that included mushrooms of all kinds,” Ms. Marley said. “We were always mindful of what we consumed and held a deep respect for nature’s bounty—knowing that what we take from the Earth and put into our bodies affects our minds and spirits, too.”

Mindful eating and respect for nature: that’s all well and good. But where do the psychedelics fit in? Excepting, of course, the worshipful use of cannabis (or ganja) as a sacrament, Rastafarianism generally abhors the consumption of other drugs. The only reference I could track down to Bob Marley himself speaking about psychedelics was in a September 1976 issue of High Times magazine. Asked if he has ever taken LSD, Marley responded: “Me hear ‘bout people who do it. No, me meet people who do it, an’ dem tell me.”

But attitudes around psychedelics are changing rapidly. And so, it follows, some Rastafarian attitudes may well be changing with them.

“Modern science is slow,” Mrs. Marley wrote. “Only now is it catching up with what Indigenous communities and practitioners have known to be true for millennia… From a Rastafarian perspective, I don’t discriminate. We honor and respect all of nature’s bounty that Jah has blessed us with and whether through ganja or fungi, we seek, above all, a greater oneness with the world around us.”

The Silo-Marley partnership speaks to ways in which the ongoing “shroom boom” seems to be following from the cannabis playbook. In many ways, comparisons between psilocybin and cannabis are, at a chemical level, largely useless. They’re different drugs, with wildly different effects and applications. Still, in the (still largely hypothetical) marketplace of legal shrooms, it helps to think of functional mushrooms as the CBD to psilocybin’s THC: a kissing cousin, with (alleged) medical and therapeutic benefits, useful largely as a way of destigmatizing the use of a more potent compound.

Gordon, himself a veteran of medicinal CBD, draws the comparison. “We looked at the lessons from the cannabis and CBD landscape,” he said. “We have that final mile to the consumer; we have a brand that they can understand, they can believe in, and they’re curious to find out more.”

On the one hand, functional mushrooms can seem like training wheels, acclimating users to the very idea of consuming fungi, and fostering curiosity about the effects profile of psychedelic mushrooms. On another, they can feel a bit like they’re stealing psychedelic valour: benefitting from the ever-building buzz around the benefits of psychedelics, while offering none of those same benefits. Really, these fungi supplements aren’t much different from medicinal mushrooms one might find at Asian supermarkets or herbal supplements stores. Just, you know, trippier. Or at least trippier-seeming. And it remains unclear just how much demand there is for such products from consumers.

The Marleys—who currently lend their name and iconic branding to a cannabis line, a coffee company, and a range of BlueTooth speakers and earbud headphones, and who, in 2017, appointed Rohan Marley as family’s own “brand ambassador”—aren’t the only ones moving into the “functional mushroom” space. Rapper and weed entrepreneur Berner, the guy behind the U.S.-based cannabis brand Cookies, recently launched Caps By Cookies, a CBD/functional mushroom with distinctly psychedelic branding, despite its lack of psychedelic outcomes.

Denver-based Mydecine, another player attempting to capitalize on the increased legitimacy afforded psychedelics, is developing function mushroom products as another potentially lucrative skew. Last week, Vancouver-based NeonMind unveiled a line of branded functional mushroom-infused coffee products.

It’s an interesting play, suggesting the widespread beshrooming of a whole sector of the health and wellness industries. But anyone hoping for a proper, psychedelic, totally legal, Marley-approved trip will have to wait for actual psilocybin mushrooms to enter the legal market, still some time away even in drug progressive places like Canada (and some U.S. states). For the super eager, there’s always those swanky Montego Bay retreats, replete with guided psychedelic sessions. Bob Marley claimed that “herb is the healing of the nation.”  For his family, fungus now seems to work that same magic.

Posted on

The Next Step for Legal Mushrooms—Losing the Trip

The latest push in the burgeoning psychedelic industry is to lose the whole pesky “psychedelic” element, and it has a surprise backer in the late Bob Marley.

The shroom industry is calling them “functional mushrooms”—a tip of the spear marketing move attempting to legitimize the image of fungi as medicine, without promising far-out, potentially transformative trips that most people associate with psychedelics.

Just what are “functional mushrooms”? They’re basically legal fungi supplements boasting various health benefits, none of which are hallucinatory, mind-expanding, or especially psychedelic in nature.

But Silo Wellness, a Canadian-based company that currently offers a range of guided magic mushroom retreats in the coastal resort mecca of Montego Bay, Jamaica (where many psychedelic drugs are legal), is hoping these shroomy supplements can help capture the emerging psychedelic market, valued at roughly US$4.5 billion as of 2020. And they’re doing this with celebrity brand recognition.

Silo has partnered with the family of the late reggae pioneer Bob Marley to launch Marley One, a functional mushroom line—tinctures incorporating mushrooms such as lion’s mane, chaga, and reishi—while eyeing an eventual, legal, psychedelic product. As Silo CEO Douglas K. Gordon describes it, in terms consistent with Marley’s own Rastafarian beliefs, “It goes more to plant medicine; it goes more to mindfulness. It goes more to embracing the fact that the Earth has its own capacity for healing.”

Rita Marley (who prefers to be addressed as Mrs. Marley), widow of the late Bob, echoes these sentiments in a statement. “Bob and I followed a strict natural diet that included mushrooms of all kinds,” Ms. Marley said. “We were always mindful of what we consumed and held a deep respect for nature’s bounty—knowing that what we take from the Earth and put into our bodies affects our minds and spirits, too.”

Mindful eating and respect for nature: that’s all well and good. But where do the psychedelics fit in? Excepting, of course, the worshipful use of cannabis (or ganja) as a sacrament, Rastafarianism generally abhors the consumption of other drugs. The only reference I could track down to Bob Marley himself speaking about psychedelics was in a September 1976 issue of High Times magazine. Asked if he has ever taken LSD, Marley responded: “Me hear ‘bout people who do it. No, me meet people who do it, an’ dem tell me.”

But attitudes around psychedelics are changing rapidly. And so, it follows, some Rastafarian attitudes may well be changing with them.

“Modern science is slow,” Mrs. Marley wrote. “Only now is it catching up with what Indigenous communities and practitioners have known to be true for millennia… From a Rastafarian perspective, I don’t discriminate. We honor and respect all of nature’s bounty that Jah has blessed us with and whether through ganja or fungi, we seek, above all, a greater oneness with the world around us.”

The Silo-Marley partnership speaks to ways in which the ongoing “shroom boom” seems to be following from the cannabis playbook. In many ways, comparisons between psilocybin and cannabis are, at a chemical level, largely useless. They’re different drugs, with wildly different effects and applications. Still, in the (still largely hypothetical) marketplace of legal shrooms, it helps to think of functional mushrooms as the CBD to psilocybin’s THC: a kissing cousin, with (alleged) medical and therapeutic benefits, useful largely as a way of destigmatizing the use of a more potent compound.

Gordon, himself a veteran of medicinal CBD, draws the comparison. “We looked at the lessons from the cannabis and CBD landscape,” he said. “We have that final mile to the consumer; we have a brand that they can understand, they can believe in, and they’re curious to find out more.”

On the one hand, functional mushrooms can seem like training wheels, acclimating users to the very idea of consuming fungi, and fostering curiosity about the effects profile of psychedelic mushrooms. On another, they can feel a bit like they’re stealing psychedelic valour: benefitting from the ever-building buzz around the benefits of psychedelics, while offering none of those same benefits. Really, these fungi supplements aren’t much different from medicinal mushrooms one might find at Asian supermarkets or herbal supplements stores. Just, you know, trippier. Or at least trippier-seeming. And it remains unclear just how much demand there is for such products from consumers.

The Marleys—who currently lend their name and iconic branding to a cannabis line, a coffee company, and a range of BlueTooth speakers and earbud headphones, and who, in 2017, appointed Rohan Marley as family’s own “brand ambassador”—aren’t the only ones moving into the “functional mushroom” space. Rapper and weed entrepreneur Berner, the guy behind the U.S.-based cannabis brand Cookies, recently launched Caps By Cookies, a CBD/functional mushroom with distinctly psychedelic branding, despite its lack of psychedelic outcomes.

Denver-based Mydecine, another player attempting to capitalize on the increased legitimacy afforded psychedelics, is developing function mushroom products as another potentially lucrative skew. Last week, Vancouver-based NeonMind unveiled a line of branded functional mushroom-infused coffee products.

It’s an interesting play, suggesting the widespread beshrooming of a whole sector of the health and wellness industries. But anyone hoping for a proper, psychedelic, totally legal, Marley-approved trip will have to wait for actual psilocybin mushrooms to enter the legal market, still some time away even in drug progressive places like Canada (and some U.S. states). For the super eager, there’s always those swanky Montego Bay retreats, replete with guided psychedelic sessions. Bob Marley claimed that “herb is the healing of the nation.”  For his family, fungus now seems to work that same magic.

Follow John Semley on Twitter.

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Mydecine: Innovative Solutions for Treating Mental Health

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Mydecine Innovations mushrooms pschedelics

Any time you have an emerging sector like psychedelic medicine, where every week new players are going public, it’s hard to determine who has real substance, a real infrastructure and real potential.

On June 22, 2021, Mydecine Innovations Group Inc. separated itself from the pack when Roth Capital Partners gave the company’s stock a “Buy” rating, citing the “blockbuster potential” of its smoking cessation therapies.

Mydecine, an emerging biotech and life sciences company, is the first to treat smoking cessation and post-traumatic stress disorder (PTSD) with MYCO-001, a pure psilocybin from natural fungal sources. They now join a short list of companies to be covered in the psychedelic assisted psychotherapy space that includes Cybin Inc. (NEO:CYBN) (OTCQB:CLXPF) and Field Trip Health Ltd. (CSE:FTRP; FTRP.WT; OTCQX:FTRPF)

According to Elemer Piros, Ph.D., Managing Director and Senior Research Analyst at Roth Capital Markets “If Mydecine gets to the commercial stage, they are looking at enormous multibillion dollar markets with very little competition. Even if you look at the risk adjusted net present value of their lead programs, the intrinsic value of the company is over a billion dollars in our estimate.”

Joshua Bartch, Director, CEO and Co-Founder of Mydecine could not be happier with the validation the Roth rating provides his company. “Roth Capital Partners is an incredibly reputable institution, and Elemer Piros is a very, very smart individual and a seasoned health care analyst. They don’t go out and initiate coverage on anybody.”

“It’s a huge validator for us because they did a very deep dive on the company. Elmer Piros interviewed our patent attorney along with our entire drug development team at the University of Alberta, so he really got to understand the business from start to finish. At the end of it all, Roth decided that they were comfortable enough to give us a very, very strong rating.”

Bartch was also quick to add, “These are not paid-for research reports. These are independently sourced.”

Roth’s coverage has been a positive event for the company. The market reacted to the news almost immediately with an uptick in trading volume and a significant jump in their stock price.

The “Buy” recommendation from Roth came mostly on the strength of Mydecine’s work on smoking cessation. Piros assumed a 5% market penetration and extrapolated out from there. This positive outlook is further supported by promising data from Johns Hopkins that shows efficacy rates in excess of 80% (12 months of complete abstinence) for individuals who had been smoking for more than 30 years and had tried to quit more than 5 times. It’s welcome news considering that 1 in 5 people in the United States die from smoking cigarettes each year.

But Bartch is convinced that Mydecine can drastically outperform Roth’s market penetration estimate considering work that has started on its second-generation drug MYCO-004, a patch-delivered tryptamine, that can be administered in a significantly shorter timeframe.

Typically, the effects of psilocybin can last 6 to 8 hours. When coupled with therapy involving trained professionals, treatment can get onerous and expensive. MYCO-004 is expected to last only 2 hours which should make psilocybin-based therapy much more viable from a commercialization and a scalability standpoint.

Bartch also sees new indications for this kind of treatment. “It’s important to note that our treatment for smoking cessation is something that can be adapted for addiction as a whole. That’s a much larger market.”

To top it all off, Pfizer Inc. (PFE.N) recently paused distribution of their market leading anti-smoking drug Chantix out of concerns it contains a carcinogen. “Our largest competitor just got taken off the shelves, which was totally unexpected,” Bartch declared. “Now it’s a wide-open market and we have by far the best drug available.”

It‘s definitely an exciting time for Mydecine, with more positive coverage expected in the weeks and months ahead. “We’ve been talking to a number of very well-known banks. Once they do a deep dive on the company and really dissect our IP, our novel molecule libraries, the infrastructure, and the team, as well as the current clinical trials and the data being produced, it’s an incredibly compelling story and it’s also much deeper and much more robust than meets the public eye.” If Bartch is right, all eyes will be on Mydecine.

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Mydecine to launch Phase 2A clinical trial on psilocybin assisted psychotherapy to treat PTSD in veterans

Mydecine to launch Phase 2A clinical trial on psilocybin assisted psychotherapy to treat PTSD in veterans
Mydecine is well-funded to advance its IP portfolio and carry out advanced clinical trials with its proprietary psychedelic molecule MYCO – 001

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By Uttara Choudhury

Mydecine Innovations Group Inc (NEO:MYCO) (OTCMKTS:MYCOF) (FRA:0NFA) is the first company to treat post-traumatic stress disorder (PTSD) and smoking cessation with the natural form of psilocybin (MYCO – 001).

The Denver, Colorado-based biotech is gearing up to launch a Phase 2A clinical trial on psilocybin-assisted psychotherapy to treat PTSD in veterans. Mydecine hopes to achieve safer and more accurate psychedelic-led psychotherapy results in a supervised setting.

“We are waiting for final approval on our Investigational New Drug before launching our Phase 2A PTSD clinical study in the late third quarter, or early fourth quarter,” Mydecine co-founder and CEO Joshua Bartch told Proactive in an interview.

Psilocybin is a tryptamine that binds to serotonin receptor 5-HT2A in the brain. At certain doses, the psilocybin elicits profound changes in consciousness and has great potential in treating mental health disorders.

Mydecine is well-funded to grow its IP portfolio and carry out advanced clinical trials with its proprietary psychedelic molecule MYCO – 001.

Roth Capital recently initiated coverage on Mydecine with a ‘Buy’ rating and a C$3 price target, citing the “blockbuster potential” of MYCO – 001 for PTSD peaking at “$3 billion five years after introduction (2027).”

Mydecine has identified four patentable lead drug candidates which include MYCO – 001, a pure psilocybin from natural fungal sources; MYCO – 003, a psilocybin-based formula with reduced anxiety potential; and MYCO – 004, a patch delivered tryptamine compound.

A serial entrepreneur, Bartch co-founded the Cannabase.io cannabis wholesale platform which was acquired by Helix TCS.

Proactive sat down with CEO Bartch to learn about Mydecine’s clinical calendar and how it is leading the charge in psilocybin and psychedelic-assisted therapeutics.

Proactive: What is Mydecine’s value proposition and why should investors care?

Mydecine has a very unique approach — we are focused on first and second-generation therapeutics derived from psychedelic molecules. The reason why this is important is our paths to approval. We have both short and long-term goals on that path and obviously the infrastructure to support both initiatives.

In our first generation, we are already in a Phase 2A PTSD and a late-stage addiction study. There’s our MYCO–001, a pure psilocybin from natural fungal sources. For the first time, a company has been able to take a natural fungal source, extract the psilocybin and take it down to 99.9% purity so it is analogous to the synthetic versions of the COMP360 products that are out in the market in clinical studies. But remember we are pulling it from a natural source, so we have full freedom to operate without infringing on any patents.

We have novel approaches to our second generation of medicines. We address things like controllability, reducing the experience time down to a more controllable hour or two depending on the indications — safety rails and we look at things like shelf stability. Psilocybin has a single molecule — it is not oxygen stable. We’ve been able to address that problem. As a single molecule psilocybin is also not skin permeable, but we’ve tailored a molecule to permeate the skin through unique fast delivery mechanisms, while making the uptick time and controllability more accurate.

By acquiring NeuroPharm and Mindleap Health, Mydecine has increased its assets and diversified into telehealth. Will acquisitions be a part of your growth strategy?

There’s definitely going to be a number of M&A transactions and consolidations as the industry progresses. You have a company like Mydecine that is well along its journey to the NASDAQ. We’ve raised tens of millions of dollars and have very solid infrastructure globally with approved clinical sites. With our exclusive partnership with Applied Pharmaceutical Innovation and the University of Alberta, we can literally go from A-to-Z on drug development with full cGMP certified pharmaceutical manufacturing capabilities on-site and in-house as well. You are going to start to see this divide between new companies that have smaller balance sheets, but potentially good IP. And later stage companies like Mydecine that have larger balance sheets and are further along in their market journey who will be able to acquire a number of these companies.

What is the kind of work that is being done at the Mydecine Center of Mycology?  

Our functional mushroom research happens in Denver, Colorado at our 7,500 square feet advanced mycology lab. This world-class lab is built around exploring medicinal mushrooms and the vast array of fungi medicinal compounds, which could potentially cure some of life’s biggest problems. We are looking at mushrooms like cordyceps, Lion’s Mane, reishi and others. We are breaking them down to the molecular level and developing unique IP around different genetics and compounds.

Our Chief Scientific Officer Robert Roscow is a well-known geneticist and worked at Canopy Growth and Ebbu where he ran their genetics division. He was the first to use CRISPR/Cas9 technology on the cannabis plant to isolate different character traits. We are doing the same thing with functional mushrooms and medicinal mushrooms, looking at what are the compounds of interest in these mushrooms.

You are evaluating PTSD, addiction, depression, anxiety, and other mental health conditions. Where are you with your clinical trials?  

In regard to PTSD, we have multiple global test sites — three in the US, three in Canada, which are all very well-known and prolific, and then there are two in Europe. We are carrying out clinical trials in three continents for the Phase 2A study of psychedelic treatments for PTSD in veterans and EMS personnel to achieve safer and more accurate psychedelic-led psychotherapy results in a supervised setting. We are waiting for final approval on our Investigational New Drug enabling studies before launching our Phase II PTSD clinical study this year.

We are taking the value that is currently present in natural molecules, such as the psilocybin molecule in MYCO-001, and adding in patentable safety features. MYCO – 001 is likely to be used at mid to late-stage clinical trials. In addition, we have a later stage addiction study that we will be launching later this year, or early next year.

So, you have an advanced clinical program calendar?

That is definitely a yes!

Mindleap is the only digital health platform that combines traditional telehealth with psychedelic medicine and mood, emotion, behavior tracking and analytics. Tell us about Mindleap.

We have invested significant time, money, and resources in Mindleap. We appointed William Cook as the interim CEO. At Raytheon, Cook designed the Patriot missile system software parameters for the US Army. He is a systems architect by profession and has a Master’s degree in marriage and family therapy. A West Point grad, Cook has been involved in massive builds and also has artificial intelligence expertise.

We have revamped Mindleap’s capabilities. At its core Mindleap was aimed at solving the issues that you have with psychedelic-assisted psychotherapy. You are looking at protocols that have tens of hours of psychotherapy associated with a single treatment. This is not accessible to everyday people as you have a limited number of locations/ketamine clinics where people can actually go and get treatments.

But when you look at the protocols, nine-tenths of the equation are therapy interactions between patient and therapist without any substance taken. These are interactions pre-and post-experience, and you have one or three possibly under the influence of a substance throughout the whole protocol. So, to be able to administer the treatments — seven, eight, or nine-tenths of the equation remotely — through a HIPAA-compliant telehealth app with trained professionals versed in the protocols is incredibly advantageous.

Mindleap 2.0 is set to launch in the coming weeks with more robustness to the platform. We have an educational platform that will share videos from top professionals, as well as audio clips with experts discussing what are psychedelics, how do they interact with our brains, what are the safety profiles of different substances, and what are the success rates? These are open questions and people don’t have easy access to professional advice.

Now you have this community-based app that individuals can go on for a low monthly subscription rate. They can not only access groups, and information, but find yoga, meditation, breathwork therapy classes, and ancillary services that promote overall mental health. We are incredibly excited about the overall product that we’ve been able to deliver.

Where do you see the psychedelic therapeutics industry five years from now, and what does this mean for your company?

You are going to see incredible advancement in the science behind these molecules and FDA approvals on a number of molecules for different indications — actually see real life treatments for individuals that have been suffering for ages with really no viable solution. We hope to be one of those making significant progress on clinical trials and the regulatory front.

Separately, one of the biggest hurdles to adoption is public acceptance of psilocybin and psychedelics. You’re looking at a substance that’s been taboo and is talked about as a party drug. However, when you look at the safety profiles of these substances, comparatively speaking to serotonin reuptake inhibitors (SSRI), a class of drugs that are typically used as antidepressants, they’re not even in the same ballpark in terms of their safety profile. Studies have shown that psilocybin and MDMA have no long-lasting effects.

Patients are also looking at one to three psychedelic-assisted therapy sessions to round out the whole protocol, compared to taking a pill every day of their lives. Most importantly, it is a curative solution, a very different proposition from popping a pill every day and feeling maybe better, maybe not! It’s a matter of time before the FDA grants approval for psychoactive compounds and psilocybin to be used therapeutically. Then you will see them enter the mainstream with profound implications for psychiatry and the treatment of mental disorders and addiction.

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Mydecine selects substance use disorder and smoking cessation for its psychedelic molecule MYCO-004

Mydecine Innovations Group Inc - Mydecine Innovations Group selects substance use disorder and smoking cessation for its psychedelic molecule MYCO-004
MYCO-004 was base templated from the company’s MYCO-001, pure psilocybin from natural fungal sources

By Patrick M. Graham

Mydecine Innovations Group (NEO:MYCO) (OTCMKTS:MYCOF) (FRA:0NFA) has selected substance use disorder and smoking cessation as the initial target indications for its proprietary psychedelic molecule MYCO-004.

MYCO-004 is a patch-delivered tryptamine compound and its properties include short duration (less than two hours), transdermal, precision dosing, and long-term compound stability.

Mydecine said it picked substance use disorder and smoking cessation for MYCO-004 as it addresses the underserved and drastic need for treatment.

READ: Mydecine Innovations kicks off machine learning-based drug discovery program with the University of Alberta

The company noted that there are 19.7 million American adults suffering from substance abuse disorder. Of those, 8.5 million suffer from both substance abuse disorder and mental health disorders.

Specific to nicotine addiction, the company said there is a current lack of efficiency and safety in the current nicotine treatments. Tobacco, and its active ingredient nicotine, is one of the most highly addictive substances in the world and one of the deadliest.

Mydecine said its MYCO-001, pure psilocybin from natural fungal sources, is in planning for late-stage clinical trials to treat smoking cessation, ensuring the quickest time course to regulatory approval.

MYCO-001’s analogous molecules have shown significantly higher efficacy rates in treating smoking cessation in well-known studies conducted by Johns Hopkins University while also showing significantly better safety profiles, the company added.

“We have taken a methodical and iterative staged approach in our drug development pipeline developing first and second-generation treatments to address some of society’s largest unmet needs,” said Mydecine CEO Josh Bartch in a statement. “MYCO-001 is our first iteration of a generation one drug for both smoking cessation and PTSD, which is currently in a late-stage clinical trial and we believe will be one of the first psychedelic treatments to receive approvals from the FDA.”

Bartch added: “Generation one analogous MYCO-001 pure psilocybin, in which MYCO-004 was base templated from, has shown efficacy rates as high as 85% in a study conducted out of Johns Hopkins University. MYCO-004 represents a second-generation improvement to replace the first generation of drugs with improved half-life control, uptake time, scalability and stability.”

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Mushroom Revival Podcast: Mydecine: Psilocybin Sciences

Published at MushroomRevival.com

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Click here to hear podcast.

Today we have the pleasure of speaking with Josh Bartch, the CEO of Mydecine, a research & development company with a special interest in psilocybin and psychoactive treatments. We discuss the origins of their work, their team, and current research and practices in the field.

Josh Bartch, Mydecine CEO
Click here to hear podcast.
‍Topics covered:
  • Mydecine’s mission and commitment to human benefit via fungal discovery
  • Psilocybin treatment for PTSD and other mental health concerns
  • Machine-learning based drug discovery
  • Formulation and commercialization of psychedelic therapeutics
  • The deficiencies in chemical compounds in psilocybe mushrooms
  • Varietals of psilocybin-containing mushrooms
  • Collaborative and intern opportunities at Mydecine’s facilities
  • Describing new compounds in functional mushrooms
  • Bureaucracy of importing and researching psychedelic mushrooms
  • Bioavailability of psilocybin
  • Managing ethical clinical research

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Roth Initiates Coverage On Mydecine Innovations With A 9x Price Target

By Shadd Dales

Investors of Mydecine Innovations Group (NEO: MYCO)(OTCMKTS: MYCOF) received a pleasant surprise Tuesday morning, drawing coverage from a firm that is making itself known in the psychedelics industry. Roth Capital Partners (RCP), a privately-owned investment banking firm dedicated to the smallcap public market—bestowed an eye-opening price target that instantly captured the market’s attention.

RCP initiated coverage on Mydecine with a “Buy” Rating and C$3.00 price target, which is a 916.94% premium to MYCO’s closing price of $0.295/share before market open on June 22. Not only did RCP recommend that investors buy Mydecine, it is projecting the company to rise 9-fold within the next twelve months. Quite the conviction call for a company in deep penny-stock territory in a sector which has been sputtering.

In its research note, the investment bank cites numerous catalysts to support its investment thesis, including:

• Mydecines ability to be the first psychedelic company to potentially use psilocybin to the PTSD and smoking cessation markets worldwide

• Mydecine plans to initiate and complete advanced clinical trials in PTSD (currently in Phase 2A) and smoking cessation with potential milestone achievements upcoming within 18-24 months

• Blockbuster potential for smoking cessation, in which research compound MYCO-001 could be introduced to the U.S. market in 2026; with a very small peak market penetration of 0.5%, the drug could have the potential to achieve approximately $2.5B in sales by 2031

Valuation

Roth’s 12-month price target of C$3/share is determined by calculating the after-tax, risk-adjusted net present value (NPV) of possible future cash flows from MYCO–001 projects. In their estimate, the probability-adjusted, fully taxed (21%) NPV (15%) of anticipated cash flows through 2035 is $1.1 billion, (US$2.50/share or C$3/share), matching its 12-month price objective.

Of course, Roth’s projections come with numerous forward-looking assumptions that are far from conclusive. The price target uses anticipated cash flows from a drug that hasn’t cleared Phase 2 trials, faces competing therapeutic research and won’t be on the market for another five years, at minimum.

But it also underscores the incredible rewards that wait for those that break through. Mydecine, engaged in Phase 2 trials and with target compounds selected, has a strong inferred risk/reward profile according to Roth. The market seemingly agrees, pushing Mydecine higher +16.95% on Tuesday on its best volume in six weeks.

TDR will have further coverage as events warrant.

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