R&D and production of fungi-derived compounds and pharmaceuticals
After successful exits from cannabis businesses, Bartch and co-founders Rob Roscow and Damon Michaels (now chief scientific officer and COO, respectively), made a play to be first movers in psilocybin and other fungus-derived compounds when they launched Mydecine Innovations Group (CSE: MYCO; OTC: MYCOF; FSE: 0NFA) in early 2020.
"We had all recently taken exits and were looking at what was going to be the next project we were going to be working on," says Bartch. "We started looking at fungi sources as a whole from a compound level, and what these compounds can do. It's really incredible the number of compounds and enzymes in the fungal kingdom, and they do everything from oil remediation to plastic remediation to breaking down wood down . . . to psychedelics and mental health compounds."
"We decided to isolate the compounds in both psychedelic mushrooms and functional mushrooms and really study those in the best way and find where they're applicable, and we came out with Mydecine Innovations Group."
Bartch highlights three focal points for the company: developing IP; clinical research; and developing complementary technology platform, MindLeap.
Front and center: PTSD in veterans. "We chose veterans for a number of reasons," says Bartch. "We understood the benefit of treating the veteran population. Historically speaking, veterans in clinical trials have a zero percent dropout rate. Obviously, this is very beneficial when you're trying to derive pure data. Also, there isn't a single pharmaceutical drug currently on the market that's made for PTSD. Everything is made for different indications . . . and prescribed off-label for PTSD."
"Every 72 minutes in the United States a veteran commits suicide," he adds. "They're prescribing them drugs -- Wellbutrin, Zoloft, Prozac -- that one of the main side effects is suicide. It's very ass-backwards, it's ineffective, it's dangerous."
A colonel in the Canadian Armed Forces himself, Mydecine Chief Medical Officer Dr. Rakesh Jetly has advised both NATO and the Canadian Armed Forces on mental health. "After teaming up with Rakesh, we acquired their company," says Bartch.
Research on Mydecine's PTSD treatments is underway. "We started launching clinical studies throughout the globe," says Bartch, highlighting collaborations in Europe and Canada. "We're finalizing a partnership with the USDA. We'll be adding New York, L.A., San Diego, and Boston as VA test sites to be able to administer our Phase II clinical studies," says Bartch. "The goal is to push the first iteration through . . . and basically make it more compatible with a therapy setting and clinical setting."
Mydecine's MindLeap technology platform facilitates treatment and will be part of future clinical research. "Being able to take care of the psychotherapy protocols remotely on a HIPAA-compliant app we own is obviously very advantageous for us as well as the potential patient."
Bartch says 80 to 90 percent of a psychedelic treatment program is "psychotherapy without any sort of substance being taken at all. You have three to five preemptive, preparatory meetings talking about your goals, building a rapport with you and the psychotherapist, understanding the positives and negatives of the whole experience."
When it comes to the "one to three macro-doses" of psychedelic compounds, he notes, "There are going to be a limited number of sites where you can administer treatment," says Bartch. "We're very confident that VA hospitals will be approved test sites to administer that, and in Canada, it'll be a similar situation."
Bartch says addiction treatment is another application, and it comes down to certain fairly universal experiences. "The barriers in your brain are dropping, and your predisposed notions are going out the window. Essentially, your brain is becoming unadulterated, allowing the psychotherapy protocols to be effective."
Mydecine grows its source mushrooms at a facility in Jamaica. "It's a unique situation where we can cultivate at scale a wide variety of mushrooms," says Bartch. "For them, it's an agricultural product. There are absolutely no illegalities at all."
The company is able to transfer material to partners via a reciprocal license at the University of Alberta in Canada. "We can legally export out of Jamaica and we can legally receive at our cGMP pharmaceutical manufacturing plant at a research facility at the University of Alberta," says Bartch. "University of Alberta is top 50 in the world for pharmaceutical drug discovery."
That makes for a turnkey operation for licensed customers engaged in psilocybin research: "We can take it from A to Z, from start to finish."
With a scientific board of 35 supporting a staff of about 20 employees, the company operates a 7,500-square-foot specialty mycology lab in Denver. "That is where we isolate the compounds in functional [non-psychedelic] mushrooms," says Bartch. "These are mushrooms that are well-known in consumer packaged goods lines."
Ultimately, the goal is to develop more efficient methods to produce the isolated compounds at a commercial scale. "We like to call it functional mushrooms 2.0," says Bartch. "We develop the IP set around to license it to consumer packaged goods companies."
Bartch says co-founder Roscow was on the bleeding edge of cannabis genetics research for ebbu, which was acquired by Canopy Growth in 2018. "They were really the first to discover CBN, CBG, unique tryptamines and compounds that are now widely known," says Bartch. "Rob is one of the smartest people you will find on the planet. . . . He very much preferred a startup's free rein in terms of being able to create."
The co-founders see a white space in fungi not dissimilar to cannabis a decade ago. "A lot of research needs to be done, but that's what we set out to do," says Bartch. "If you look at shamanistic practices over the years, in many cases they have five different types of mushroom varieties and they use them for very different things. What that tells you is, just logically, is that there's much more going on than just psilocybin in these mushroom varieties. Keeping that same kind of notion for us and our science team, we want to understand it very much like they did at ebbu. What else is going on there? What we're finding is there's a ton of unclassified , very active tryptamines that are working either synergistically or against each other. We don't really know, but were quickly finding out."
"We're identifying, isolating, classifying, synthesizing these molecules," he adds. "Once you can understand the whole picture, then you can pick and choose like a sound board if you will of which ones you want to use together to hopefully create the perfect outcome, and that is very patentable."
Challenges: "Obviously, the pandemic is a challenge," says Bartch, noting it made collaborating with various higher education institutions difficult if not impossible to launch clinical trials.
"Public acceptance is one of our greatest hurdles," he adds. "People are so stuck in their ways of taking pharmaceutical drugs -- a pill will fix everything, even though it's incredibly dangerous and incredibly ineffective, and what we're offering is a non-invasive, non-addictive substance that has in many cases 70 to 80 percent success rate off of one to three treatments with no known side effects."
"Just because of the positioning of psychedelics throughout history, these people think if they take mushrooms, they're going to think they're an orange for the rest of their life and never come out of it. That's simply not true. Administered properly, these are very safe and effective treatments."
Opportunities: Millions suffer from PTSD and addiction, but treatment options are limited, says Bartch. "Obviously, addiction and PTSD run hand in hand, but are both very, very large populations."
Providing materials for licensed researchers all over the world is another opportunity: "We can provide at-scale, cGMP psilocybin that is both synthesized and naturally derived . . . human use at the end of Q1 ," says Bartch. "We'll be able to provide it significantly cheaper than what is out there right now."
Needs: Talent, Bartch anticipates a capital raise in Q1 2021 and 10 to 20 new hires by early 2022.
A profile boost is another big need. "We need support -- people getting behind our message and behind our vision and really listening to our educational tools," says Bartch. "We do a Mydecine Speaker Series. This is a free event where we bring our scientific advisory board and medical advisory board members, some of the top researchers in the world, and it's an open forum and a live, hour-and-and-a-half event."
"The goal is to spread awareness about our cause and psychedelics as a whole and psychedelics and psychotherapy as a whole, and spread the awareness that this is a new wave, and it's not the bogeyman and it's a very effective treatment that the mainstream should really adopt."
Bartch concludes, "We need people to tune in and be open to something that's against the norm."