Mydecine: Psilocybin Sciences

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Mydecine: Psilocybin Sciences

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.

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

Show notes:

 

TRANSCRIPT

 Transcribed by https://otter.ai ** Subject to error

Alex 0:00
You're listening to the mushroom revival podcast.

Lera 0:12
Hello Friends Today we have the pleasure of speaking with Josh Bart who is the CEO of myosin, a Canadian biotech company who aims to increase efficiencies in fungal pharmacology. They have a specialty in psilocybin, but focus on all functional mushrooms medicine has operations in Denver, Colorado, where they've built a 7500 square foot lab dedicated to the research and development of these unique fumble compounds. We also discuss the economy of psilocybin as it is seen through the lens of medicine and similar emerging businesses. And we apologize in advance for the some of the noise issues in this interview. But without further ado, we bring you Josh March. Josh, thank you so much for joining us today to talk about medicine. Could you tell us a bit about yourself, and then give us the one on one pitch to medicine?

Josh 1:02
Sure. First of all, thank you for having me. Excited to be here. myself. My name is Josh Bart's. I'm the co founder and CEO of medicine innovations group, personally born and raised in Denver, Colorado, still reside here in Denver, Colorado part of the year and then I'm fortunate enough to also reside in San Juan, Puerto Rico. As far as medicine innovations group medicine innovations group is kind of a global company focused on both both first in general first and second generation novel therapeutics revolving around different psychedelic compounds. So what we've been doing is basically taking nature's natural design of compounds like psilocybin and cillessen, using that as a template, which has a ton of great features, and then improving and making iterations from a pharmaceutical lens standpoint, upon those initial designs to make them more applicable to therapy to make them more acceptable in the FDA, eyes, etc. Things like shelf stability, being able to control HalfLife, etc, to make them much more scalable as well. And then additionally, medicine has invested heavily in a technology platform by the name of mind leap, which we're getting ready in the next couple of weeks here to roll out mainly 2.0. We're incredibly excited about that. But mainly 2.0 is a community based really advanced HIPAA compliant telehealth platform that really kind of gives it gives a solution to some of this the scalability issues. as it pertains to the psychotherapy protocols that's associated with some of these treatments. It's very onerous to expect patients to travel sometimes over state lines, sometimes over country lines for several psychotherapy interactions that don't actually involve any substances taking at all that are one on one interactions, both pre and post treatments, that again, are no substances taken at all so mildly provides a platform that those interactions can take place remotely as well as mainly 2.0, which will have a ton of additional features things like yoga classes, Breck breathwork classes, ancillary services, that, again, are community based that are from best in class providers that really promote the overall mental health and well being. So that's kind of mildly our that's kind of medicine as as a company, our two main focuses, as far as indications are concerned, are PTSD and addiction,

Alex 3:32
and how yourself, did you get introduced to the fungal world or the world of entheogens?

Josh 3:39
Sure, so, you know, professionally, I spent over a decade in the cannabis space. So I was I was a third legal cannabis license granted in the state of Colorado, which is really the first kind of for profit business structure on the planet. Right. So we really innovated that, in Colorado, I built a fully vertically integrated national company, it was really one of the first if not the first to do as a state, a multi state operation, single brand, etc, but was a fully vertically integrated company, and had a vast access to a multitude of of the business and really saw what cannabis could do from a healing perspective. And then really understood kind of, you know, the different compounds that were associated with the cannabis plant, which ultimately ended up which which is why I ended up partnering with with David Michaels. And, and and Rob Roscoe, our CEO and CSO, who came out of out of a company by the name of eboo, which was a Colorado startup initially, really focused on the pharmacology aspect and under understanding individually what these compounds did, and then looking at the entourage effect and with the ultimate goal of having kind of predictive outcomes in November of 2018 eboo was acquired by canopy growth for 429 million for the patent portfolio that they had had built and really understanding that we got together and kind of started talking about kind of the world of fungi in the world of mycology and how it was relatable to kind of the cannabis plant from potential standpoint. But the world of fungi is much more vast and the potential is, is much more vast as well and also less understood. Right? There hasn't been nearly amount now they're starting to be an onslaught of significant research being done on both the functional mushroom side as well as a psychedelic side. But as far as the potential it's really untapped. So it was an incredibly exciting opportunity and something that we jumped in, really headfirst. And that's how Madison was born.

Lera 5:41
Yeah, you have a lot under your belt, and it's cool that I'm seeing, you know, Madison using psilocybin and functional mushrooms. And you're pioneering a lot of r&d with within both of those spaces. And could you talk about neuro farm like Who are these people and what I know you guys are working with traumatized military populations. But yeah, if you could kind of describe the relationship you have with with neuro pharma Inc.

Josh 6:08
Sure. So neuro farm was actually our first acquisition that we did. So we fully acquired neuro farm neuro farm is now a part of myosin so so the entity of neuro farm is no longer in existence. However, the team of neuro farm and also their their vision, their operations, etc, is now one of our key and leading initiatives. So our chief medical officer, which we were fortunate enough to be able to acquire during that transaction, as well as Dr. CASS jetley. Dr. Rick has gently just retired in February after 31 years in the Canadian Armed Forces, the last 10 years, he was the chief of psychiatry for the entire Canadian Armed Forces. But I spent, you know, 31 years, obviously dealing hand in hand with different traumatic PTSD, etc, addiction that that revolves heavily around both the current active as well as veteran populations. He's one of the world's expert leading experts. He's chaired a number of NATO boards globally, around the topics of PTSD in the veterans population, and kind of through that, we've been able to attract really the who's who, from a variety of different governmental agencies, militaries, etc, most mostly retired, etc, but the rank of colonel are above that have really been pioneering PTSD research globally for the last, you know, three decades. So through that, obviously, inherently, we have launched our phase two, a clinical study around PTSD, utilizing psilocybin assisted psychotherapy, as a generation one treatment for the treatment of PTSD. So if you reverse back to the 1950s 1960s, when there was a ton of clinical research being done on kind of this blanket depressive disorder, right, so 1950s 1960s, PTSD was not an indication that didn't happen until the 1980s, when they actually classified it as an indication when they were like, you know, these nightmares, all these other things, what's really going on here, there's much more than just blanket depressive disorders. But if you look at the 1950s 1960s, when they were treating very successfully treating this blanket Depressive Disorder, With psilocybin assisted psychotherapy, and other psychedelics as well, but specifically, in our case, psilocybin, if you look at the derivatives of some of these patients that were being treated, it's from very traumatic events, so things like Holocaust survivors, or war, veterans, etc, that were coming home with these crazy traumatic experiences, and really nowhere to turn. And then again, they were successfully treating obviously 1960s, early 1970s, all of that was halted for political and bureaucratic reasons, right, that obviously we don't agree with. But we're very happy that this resurgence of, of treatments, so we're building up a very large body of evidence that we know that this this treatment works, and will work very successfully. So that's really what kind of the basis of why we launched our PTSD studies. So now we have approved test sites throughout Europe to in Europe that are military focused three and in in Canada, University of Alberta, Royal, Ottawa, Western Ontario, and then three in the United States that are very veterans focused as well, very prolific sites that we'll be announcing here soon. And the idea is, again, is to really understand right now, there's more questions than we have answers, but we do know what works but we don't know what the best protocols for instance, are, or is it 50 milligrams or 25 milligrams, etc. So we're doing a phase two a, as an investigator study to really hone in on the best protocols to move into our phase three that will be happening, hopefully, you know, late 2020 to 2023, etc. So something that we're very excited about,

Alex 9:54
there hasn't been much research into, you know, the different molecules inside psilocybin containing mushrooms, and you know, there's preliminary research, a lot of people are most concerned about psilocybin and cillessen. But there's other molecules like nor cillessen, bio system nor bio system, etc. These are a company focused on exploring these, this entourage effects of the multiples of different compounds inside of these mushrooms.

Josh 10:26
Yeah, the answer to your question is, is absolutely. So this morning, actually, we announced put out a press release that at the University of Alberta, which is where the vast majority of our psychedelic research takes place, we have identified and now classified, over 40 active compounds that have never been discovered, or classified, or categorized from psychedelic producing mushrooms. we screened over 25 different varietals to actually uncover what these compounds are. And then something really unique at the University of Alberta that we have access to is their AI technology. So we're able to effectively instantaneously take a number of compounds, and instantaneously screen them to find out if they're active or not, right. So something that five years ago would have taken a decade for individuals to do and millions of dollars were able to do very inexpensively and quickly and efficiently. So what we're finding is exactly what you indicated that there's much more going on, in these psilocybin producing mushrooms and just psilocybin or cillessen, which we we didn't know, or we, I guess anecdotally knew, if you look at kind of ancient shamanistic practices going way, way back, right? When they use silicided mushrooms for shamanistic practices, or whatever it might be, in many cases, they have two or three different varietals that are used for different things, right. So what that's telling you is that they have different effects, obviously, which means that there's much more going on than just psilocybin or cillessen. There's an interaction of different trip domains, compounds, etc. So, obviously, we're very interested in understanding that. And I think that these compounds, which is really interesting to us, especially with our AI technologies, hold the potential to go far outside of just mental health, right? Everybody's focused on just serotonin receptor basis, which is fine, because they know that psilocybin and cillessen bind to different serotonin receptors, but nobody's really looking at outside the box. So what we're able to do with our AI technology, is, again, instantaneously take these compounds that now we know are active, and screen them against millions of receptor basis to see where the unique hits are. So, you know, we're really pioneering some very interesting research up there. And we're going to continue to expand upon our library of genetics that we can, you know, really, really kind of rip apart on an individual level, we like to call it the Coinstar of, of compounds, take them down on an individual level, understand what they do individually understand the potential and then look to maybe reformulate and put them together for the ultimate goal of of trying to eliminate things like anxiety, etc, to be able to have really the ultimate formula, if you will.

Alex 13:22
And this scanning technology isn't just for, you know, entheogenic mushrooms, this is for all mushrooms and potentially pretty much all biomaterials, right, all plant based, you know, materials and things like that. So that that's really exciting. Obviously, entheogenic mushrooms have a lot more economic incentive right now. But, you know, it's also very exciting for our understanding of the natural world around us, especially just we know such a small fraction of the natural world around us, but to you know, look under the hood, so to speak of what is actually going on, right if we ingest some of these, you know, bio substances, how is that interacting with our body and to gain a deeper understanding and also for the pharmaceutical pharmaceutical industry of you know, how can we create new drugs for people that can really have a great impact on their life or even help better understand the whole plant right if you know we have herbalist or whatever? What's going on what are those actives and have a wider view so is that kind of what you're doing with medicine, Health Sciences is is looking using this technology for you know, functional mushrooms and more mushrooms that just the entheogenic ones

Josh 14:51
100% So, obviously, you have your usual suspects. So just just so your your listeners understand. So we have really two kind of divisions, right one is medicine, health sciences, we have a dedicated 7500 square foot lab. here in Colorado, it's really the first kind of, of it's kind of a specialty mycology lab with end to end technology capabilities. Ranging from all the benchtop that you could ever want to HPLC to you name it, we pretty much have it in that facility. And we're looking at specifically functional mushrooms and different compounds found in mushrooms like cordia seps, Accordia, cept, and but looking at ways to kind of refine and piggyback off of some of Rob's work that he did in the cannabis base, he was the first to use CRISPR, cast nine gene editing technology on the cannabis plant to isolate different character traits and create a single ies compound cannabis plant. So a CBD only plant a CBG only plant, a THC only plant, obviously resulting in a much more fruitful plant, specifically to that compound, right, it's not wasting energy on on different compounds of interest. Same thing is true in these different functional mushroom basis. So we are not interested in really producing end user products. We're more of a scientifically driven IP company that really wants to increase efficiencies and look at the ways to, you know, create new genetics that exploit compounds of interest, but also, like you said, understand, much more fruitfully I guess, and much more in depth, what are these compounds doing? And what are their potential, so we know things like restaurants, christenings and Lion's Mane or kordia, septin, etc, can be really good for a variety of things, because there's been some baseline research, but nothing, nothing was much more in depth from that. And there's also a very limited supply in these mushrooms, right, like personal interest means occupy maybe 1%, or 2%. Same thing as as like a psilocybin or cillessen. And in a psilocybin producing mushroom, right? It's a very small percentage base of the overall composition of the mushroom, right, and, you know, looking at ways to isolate those compounds create genetics have specifically produced that compounds much more fruitfully, but like you said, also classify a significant which we're doing a significant amount of other compounds that could be of interest or potentially could be, you never know, the next penicillin, right? I mean, that came from a fungal source, and it was kind of an accident, so you don't know what you're stumble upon. But what we do know is that, you know, the fungal world is, is incredibly exciting, from a multitude of different aspects. So,

Alex 17:32
I really like that approach. And I respect it, because a lot of people say, say, quarter sets, for example, are, you know, only concerned with quarter sippin, you know, and that's the most famous compound in there, or in entheogenic, mushrooms only consists concerned with psilocybin, so to speak, or cillessen. And so to do to look under the hood, but then also be able, if there's other compounds that are actives, or they help with the entourage effect, we can use this technology to enhance it, right. And this is what we've seen in cannabis, this is what we've seen. You know, even in in micro remediation, this is how we make it on the industrial scale, right? Sure, there's naturally occurring fungi that can degrade toxic waste, but we can use this technology. If we know the enzymes, we can enhance a fungal species to produce more of them to right to, to better degrade that toxic waste. And same. If we know these pathways to produce compounds, we just produce more of them. So it's more sustainable, more economical, to produce less mushrooms with more more bang for your buck, so to speak. And, you know, it's probably better for the environment in the long run, you only have to produce so much to get that those supportive effects in the body. So I think that's really, really cool what you guys are doing?

Josh 19:05
Yeah, no, absolutely. And it's something that we're very excited about as well. You know, it's the Medicine Center of mycology, my calm is what we call it in Colorado. And, you know, we were starting to look at opportunities to collaborate and offer intern programs with, you know, University of Denver, University of Colorado, many of our scientists come from those schools already. So, you know, to look at ways to offer internships because this is incredibly promising. An incredibly promising field, like you said, myco remediation, right? That's incredible that that can happen. And it's from a naturalistic source, right? So there's a ways that you can take that completely take that as a starting point and modify it to be much more effective and much more pointed, and you can really potentially solve a lot of the world's problems with these symbols, you know, this, this, this simple fungal sources. So, obviously, you know, that's not our main focus. Where, when anytime you build a business, you can't be have too many tentacles out there, especially startups, right? So we are hybrid on what we're doing. But at the same time, you know, we that doesn't mean that because of our capabilities, we can't have side projects or side interest, or a platform where other companies can come and utilize our space to collaborate, and maybe look at some of those other alternative potentials as well.

Lera 20:28
Yeah, this is so awesome. You guys are like a hub of discovery. And this spaces like this exists for cannabis now, and they did before for plants and other drugs, but to have a myco centric and myco literate lab, to the sophistication that you guys are going for is so exciting. And I think something that the United States has been way overdue for. So thanks for pioneering this and establishing it, I just have to say from the little that I do know about fungi, they are chemical machines, and the ability to look at their genetics, like I mean, there's so many fungi that have the genes to express a certain compound, but don't in nature, and you can change all these environmental factors. And they don't actually ever end up expressing that. But I mean, just that little bit of insight to how impressive a single species can be, how variety they can be 100%, I'm so excited that you're offering internships, and I hope our listeners got a little sparked up and were like, Hey, this is, you know, something I could look into? So could you maybe talk a little bit about that? When are you welcoming people? What, who's eligible to come in and work in this space? And what exactly can they do? At an intern level?

Josh 21:42
Sure. So you know, generally speaking, what we're looking at as either masters or PhD students from the surrounding area. So you know, we got a number of college campuses here, but University of Denver, the EU as it is known, see you the buffaloes, and then we have a couple campuses down downtown that are that are State University, Metropolitan State University, as well as CCD. So we're looking at, you know, either master's level or PhD students. Right now, we are in the process of getting ready to work with the universities to be approved. internships, so they're getting credit for coming to work for us, obviously, you know, we needed to get it to a point internally from from a company that our projects were far enough along, as well as our infrastructure was, was there to be respected and seen as a legitimate research facility, as well as a legitimate research company, which now you know, we're definitely there for sure. Something else too, that I want to touch on that that is kind of in the pipeline. So we're talking about my comm, which we think is really exciting, kind of the next generation of getting people in the younger generation excited about mycology is we're going to launch something here, and q3, or q4, we have a full classroom, in our facility. So something really unique about our facility that we were really excited about when we actually designed and built, built out the lab space. But we have about a 2000 1500 square foot classroom that we use as kind of a board room as well. But it's much bigger than that. And it has a stage and we built all the infrastructure to be able to put on for our classes for kind of the elementary, middle school level to do field trips. So we're going to start working with some of the local local schools and districts to be able to offer to bring their kids to come into the lab. And since we're not doing any psychedelic research at that lab, as of yet, we do have a DEA application and but as of right now, we're not doing anything around the psychedelics and it's completely legitimate to have them come in and learn about, you know, these different fungal sources get excited about the science and really kind of promote that next generation of potential mycologist or potential, you know, scientists that that may be unlocked the next big invention, so something that we're really passionate about, and we think is a really cool initiative as well.

Alex 24:15
Thanks for doing that. I, I don't know if you've heard of the International medicinal mushroom conference, but a couple years ago, it was in nonton, China, and there was a few different companies I saw doing similar work to you have of you know, looking for new species of fungi, and a lot of times in very extreme settings, like, you know, Antarctica or in acid pools or whatever, or volcano Bay or whatever. And, and, you know, looking under the hood, looking what compounds are they're making a whole library, and then finding out what new compounds can be of use to humans, right. And so it's exciting to see that happening in the US and also myco education from, you know, I saw someone offering it, preschool to PhD school on my mycology in China. And we're just so far behind the US, but where we have a leg up, so to speak, is in this entheogenic research where you guys could find, you know, 40 compounds and these entheogenic mushrooms were so many countries, they don't have that opportunity. So that's really, really exciting. And I have kind of a funny question, because we interviewed Dr. David Nichols. And if you don't know who that is, yeah, yeah, he I mean, he's groundbreaking for any listeners, we probably have already released the episode. But at one time, he was the only person in the United States legally allowed to synthesize LSD and has been groundbreaking for psychoactive pharmacology. But, you know, we asked him, How he was able to transport these compounds, you know, from lab to lab, especially doing human clinical trials. And we thought it was so funny. He said, FedEx. Yeah. And so when you were just talking about, you know, transporting these these mushrooms or extracts or whatever it was from Jamaica to Alberta? How did you do that? And what kind of permits what was kind of the structure to go about that process?

Josh 26:29
Sure. So it took us It took us over six months, okay? Because you have this this weird dichotomy. So we have, we have a schedule One Health Canada dealer's license, that's housed at the University of Alberta, right through our exclusive partnership with applied pharmaceutical innovation. And under that, when you have any sort of drug development license, which is basically what it is, at its core, you have a number of different amendments, or allowance, if you will, that gives you you know, check the box. And you can do this basically. And what we have on that is a very robust kind of set of amendments. And one of those is import export, commercial scale extraction, etc. So we have the full capabilities to do everything around scheduled one, so we could do you know, anything that's scheduled one outside of just psilocybin, we could do anything that's scheduled one, but on the other side of the pond over in Jamaica, because and obviously, we know in Canada, right, it's a schedule one substance. In Jamaica, it's listed as an agricultural product, so no different than like a button mushroom that you put on right repeater, right. So you have this incredibly weird dichotomy where they see it as just no big deal. It's a it's a, you know, an agricultural product, and then it's a scheduled one, you know, substance that's incredibly serious. So it took us six months working with jam pro jam Pro is the agriculture oversight committee and in Jamaica, that oversees landport export of agricultural products, and then Health Canada, to develop protocols that they were both comfortable with, to be able to actually cultivate in Jamaica, run it, you know, get CEOs at University of West Indies, make sure that everything that we say is in the package is what it is, and then get the actual import permits from the export permits from Jamaica, and then the import permits from Health Canada to allow us to bring it in as far as as far as the shipping DHL so I mean, I gotta tell you, you know, when it when it when it comes to, you know, butterflies in your stomach or nerve racking, I must have refresh the screen on the tracking 1000 times a day, you know, because I'm like, this cannot be real, even though you have all of the legal paperwork that you've worked on, and you made sure all the eyes were dotted and T's were crossed. It's still just, it was the first in the world to ever do an international export or import of, of these these substances. Right. So it was definitely legally. Exactly. Legally, exactly. That's the caveat, the important caveat, but it still felt like you were you know, like you were you were crossing some sort of gray area or doing something wrong. So Right, right. You know, once it once it landed successfully, it was a big hurrah. Okay, less than that, you know, let's, let's do another one. But it was definitely interesting, for sure. And, and something that we've been able to take full advantage of. And again, so so why Jamaica is so important and kind of art and to go back to what we talked about, about the entourage effect. So when you look at substances that are explicitly illegal and the vast majorities of the jurisdictions globally, when you're bringing in those substances into a drug development license to be classified, it's very hard, right? It's like how do you take something from the street basically, and bring it into this drug development and have them be okay with it, right. So, the way that Health Canada and the DEA licenses as well but specifically for our purposes, Health Canada has The requirements is that the opposing jurisdiction or the originating jurisdiction has to have it either listed as fully legal, and you have to be able to prove that. So in Jamaica, we were able to do that, or it has to come from a reciprocal license, like a DEA license, or, you know, some sort of drug development license in some other jurisdiction, but they would have had to have brought their genetics in some way as well. So you're very limited to the ability to actually bring in varietals, from different areas, right. So Jamaica offered us this huge open door is a temporary, we don't know, but it doesn't really matter, because we've been able to do this for some significant amount of time. But we could come compile available genetics in Jamaica, and then ship those up to our world class research facility, that we have the ability to really rip them apart and find out what's going on, like you said, underneath the hood, so you know, really, really exciting stuff, really, really innovative stuff. And, and something that's been a lot of fun to be a part of, for sure.

Lera 31:01
I'm so excited to continue following your work. I had another more specific question, just from like, looking at your website and looking at your r&d. You mentioned a psilocybin dosing technology. Is this just helping people understand, like a proper dose of psilocybin from macro versus micro dosing? Or like, what exactly does that mean?

Josh 31:26
Yeah, so there's a number of different dosing technologies that we've actually been able to develop at at Madison, and some that are very unique to us and more specifically, and something that I can talk about openly because a lot of these are still in development. And obviously, there's there's patent work around that. But what we've been able to do on on our myco 004 product, which is a second generation, that again, was a starting point for the these this from psilocybin or so sin. So silicided and cillessen. As compounds are not skin permeable, as they stand as a molecule, they don't penetrate the skin very well at all. That's why you see if there's a patch system that has like the myco slivers where they basically cut your skin, etc. We've been able with our drug development team, Dr. Dan Hoyer spent three decades designing small molecules of Pfizer, Novartis, and most recently was the head of small molecule design at Yale Medical Center, in conjunction with Rob Roscoe, our CSO. And then the faculty of pharmacology, which is ranked top 15 in the world at University of Alberta, to tailor and iterate these different molecules to have other features. So in prior research, for silicides been the most effective way to regulate dosing is intravenously. We just don't think that that's compatible with therapy. I don't like needles, most people don't like needles. And definitely if you're under this crazy experience that can potentially be very radical and mystical, if you will, as it's known, you know, you don't want to have something sticking in your arm, right? It could be you could have, it could have negative effects. So the second best that we saw as a patch delivery system, but again, you had an issue where the molecules don't permeate the skin, so we were able to actually modify the molecule to make it permeate the skin we have patent pending on that as well. So we can apply psilocybin and all psilocybin and silicides, SLS and like analogs, tryptamines, etc. all as all encompassing, and the same mechanistic changes to that molecule actually apply and work for all of the different molecules. But we can apply that Nat now to a patch delivery system, which is obviously very significant. The other component to myco 004, which is very unique, and also from the FDA lens. Very important is when your body is psilocybin, right? psilocybin as a molecule is not psychoactive your body metabolizes through the liver, and then it creates cillessen cillessen is the psychoactive compound. The reason why people don't use cillessen and drug development for the most part is because it's not oxidatively stable or shelf stable, right. So like when the mushroom blues bruise is blue. That's basically the degradation of psilocybin and cillessen. And that's why it's bruising blue turning into blue dye, which is obviously has no psychoactive or any sort of medicinal effects at all right, it's just basically ruined. So we were able to create a way to keep that molecule already converted to sosin, shelf stable, or significant amount of time, which obviously the FDA approves, but also what that does, is it makes it instantaneously psychoactive so obviously you don't wait time, which is incredibly beneficial. So, you know, you start to layer these different features, which creates a much better, much more scalable, and then lastly, we were able to tailor that molecule as well to create about a two hour half life so what you have in myco 004 is a cillessen like tryptamine that's full shelf stable skin permeable, and has about a two hour Half Life delivered on a patch system. We think it's an absolute amazing second generation, we also have about five layers of patent protection on that, on that actually actual discovery. So something that's very unique, very exciting that we've been working heavily on for quite some time.

Alex 35:20
If that's what you could tell us, I'm really curious what you have behind the scenes. That's, that's really incredible. And why why a patch, as opposed to, like Orly ingestible?

Josh 35:32
Yeah. So you know, again, we have the way to make it skin permeable, which if you look at some of these dissolvable strips that people are doing, right, it's just basically a breath mint with psilocybin, and then you swallowing it the same way. Right. It's, it's not it's not very good at permeating the skin. So unless they have our feature on it, that it really doesn't make it better in our opinion. But the answer to your question is, is, you know, we think that patch is is very compatible with, with therapy, one of our addiction protocols already, what's out in the in the public markets is a patch system to make them you know, to try to help them quit, it's very uneffective. But that's what's already attributed to it. But also it's it's soothing, and we think it's it's a very, very controllable uptake time, right, it doesn't, it goes directly through your skin into your blood. And then, you know, you're, you're off to the races. So it's very controllable. It's unique, a lot of people and in traditional pharmaceuticals, they don't use patch, because they're generic drugmakers trying to lower the cost down to next to nil, obviously, in this particular substance, or in psychedelic assisted psychotherapy, right, that you have 123 treatments where you're actually utilizing the substance. So cost is not so much of an issue, right? Because obviously, it's probably going to be a very expensive treatment. Either way, insurances is going to have to pay for it to make it viable. But anyways, needless to say, that's, that's why we, we chose for that specific product. But like you said, You know, I mean, we have libraries of compounds, libraries of invention. So we have other delivery mechanisms as well that are in development.

Lera 37:10
They have a chemistry question. And I'm not a chemist. I don't know if you can speak to this. But you talked about, you're not either. No, no, no, no, I'm not. We have much smarter people on my team, then. Okay. Well, that, but if you let me know the question, I'll give it a shot. Okay, so you are altering the psilocybin or cillessen molecules to be permeable through the skin. So when I when you look at this molecule, it's maybe not technically considered cillessen anymore, or it's close enough that it will still bind to the same receptors. But has your team investigated the difference between Orlando resting psilocybin versus doing your patch psilocybin with whatever extra items that you needed to latch on for it to go through the skin? And how much if at all? Do they differ in neuro chemistry?

Josh 38:01
Yeah, so So what we've been very cognitive of in designing that specific molecule is not changing the properties as it pertains to how it affects and binds to different receptor bases, but also the effects that it has on your body, right? These are iterations that change the structure that make it permeate the skin specifically, but as far as the effects that it has on humans, we believe through our preclinical studies, that they're going to be identical, there's no difference. Things that, you know, we're altering, as far as effects are concerned is half life. But as far as the mystical experience, what you're going to undergo the introspective ness of it, etc. We're not changing that, that that side of things at all, we hope.

Alex 38:51
So cannabis blew up, and you probably had a big hand in making that happen. Do you? Do you feel like psilocybin will be bigger? Or do you think there's a bottleneck because of the rules and regulations and laws, that it can only grow so much? in that kind of environment?

Josh 39:16
Yeah, so totally, totally different approach. Recreational market place for for cannabis, we see and have zero interest and a recreational suicide and or psychedelics market for that that matter at all. I think that you know, what people do on their own recreationally as their as their own their own choices and and listen, you know, if you want to go do some psychedelic mushrooms, that's fine, be nice, be safe, etc. but but if it's not in a controlled environment, it's not as effective to actually treat successfully elements, right, the psychotherapy protocols and the psychotherapy aspect of this is so important and if It's not coming from a trained clinician or therapist in a very controlled setting, sometimes you can have negative effects, etc. And ultimately that can ruin an industry for the masses. Right? I think that from a D krim standpoint, we're big proponents of it from a state program, as long as it's done responsibly. You know, we're big supporters of it. For instance, in Oregon, Dave cuplock, at emerge Law Group, I've worked with them in cannabis for over 10 years. I was one of the first licenses in Oregon as well. And he was one of the main architects on that bill out there. I think they took a responsible approach. So we wrote him a check, we supported that initiative. Unfortunately, we can't actually participate in the operational side of that, because it's state we're going after federal FDA approval on drugs and you just can't cross that. That line in the sand. It's a very, very strict line in the sand. But for us, anything that's done responsibly, that promotes the overall acceptance, like we are, we're big time supporters of right. But as far as as the way that the market is, and the size and potential of the market. Again, I think it's two totally different ballgames. One is a pharmaceutical marketplace that we're creating real FDA Health Canada global equivalent of drugs, that are displacing over $100 billion of dangerous, unsuccessful pharmaceutical drugs that people have have been complacent, taking for, you know, decades, for no apparent reason other than just not thinking outside the box, and not looking at what's already really kind of been in front of you. So you're displacing with much more effective treatments, huge amounts of dollars. So I think that this marketplace is significantly bigger than the cannabis industry. But again, it's a much more scientifically pharmaceutically LED marketplace, as opposed to a recreational side of things.

Lera 42:01
Totally. And like cannabis is something that people can participate in daily. But psilocybin doesn't seem like a habitual thing as much of a device, obviously, there's microdosing. But, you know, the goal of it is to, to stop consuming it right to be okay. So it is very different models. But it's great to see people who have gone through the legislation of legalizing cannabis into the mushroom space to do it right. The second time, right, this is a resurgence. And it's, it seems to be going really well, because responsible, really intelligent people are on board. Absolutely.

Alex 42:38
What, what worries you about this booming industry? Do you think there's there any caveats to the growing economy of psilocybin? I'm seeing companies pop up left and right, and going public, left and right. And, you know, there's a lot of money being poured into the space. And yeah, what is there anything that keeps you up at night, or, you know, you see as maybe a potential downfall?

Josh 43:08
Yeah. So I mean, I think that in any emerging markets, that you're taking something that's so taboo, for good, bad or ugly reasons, doesn't matter why, and bringing it and trying to get public acceptance, right, it's, it's very hard, and you have a lot of naysayers, and you have a lot of people hoping that you're going to fail. And you're also dealing with competitive landscapes of very large pharmaceutical companies that were potentially replacing very profitable drugs have, so they're also going to look at ways to you know, how do we poopoo this or look at ways that that you, you know, to make it look at it looked at or viewed in a negative connotation. And how that happens is by bad actors, bad players, and anytime that you see this emerging markets, and this many companies going public, this quickly, this late in the game with no IP, no substance, no nothing. Right. And they're just basically we call them PowerPoint companies, it's really bad for the industry, because all it is is just a stock promote, or something of that nature, that people are looking to make a quick buck. And ultimately, people are going to lose money on the deal. And nothing is going to happen fundamentally with the company and you're going to have a lot of, you know, very angry people. And that's what we that's what concerns us is the me to companies that jump out and just try to ride the wave with really no intention of discovering or helping people are really making any sort of scientific progress at all, or no ability to do that either. Right. So you know, that's concerning. Also, you know, it's concerning with kind of the attention anytime the spotlights Come on, on, on certain subjects. says these are incredibly safe substances if they're used, right, right, if the say if you look at a safety profile of suicide, and comparatively speaking to an SSRI, let's take it, it's not even comparable, right? Like this is much more safe than an SSRI or a traditional pharmaceutical. As far as side effects are concerned, and you're also only looking to use one to three macro doses in a traditional protocol, and it's curative, potentially, right? This isn't an everyday pill, etc, etc. But if it's not used properly, there is the potential for people to do things, when you're under the influence, that could really put a bad mark on the industry and make it look like this is just as crazy psychedelic experience. And something somebody jumped out of a window or something crazy like that, right? Because that does happen if it's not used responsibly. So the emergence of an ease to access potentially, when people see an underground market, that concerns me, because it's, it's just, you're always going to have, there's nothing bad that can happen about that right, unregulated markets, etc. So that that is very concerning for me, but ultimately, you know, when you when you take good companies, and there's a number of them in a space that we like, and we work with them, we support each other, etc. that are doing really good work with major research institution as well. Right. And ultimately, what wins is data. And it's it's, it's undeniable, how good the data and the science, you know, the different the different data points that are coming out of these clinicals, whether that's maps, or even compass, or a lot of the Hopkins work. You know, we're very close with a lot of guys over at Hopkins and and work collaboratively with them as well. But you know, that's what's ultimately going to take the naysayers to be supporters, his stories, word of mouth, and then ultimately, data is how you really convert the masses. So as long as that continues, and there's there's no bad players that emerge, that I think we should be fine.

Lera 47:02
Thank you for your insight. And then to kind of wrapping up questions. One is how can citizen scientists help you if at all, you know, people who are dedicated to the space and just want to support your awesome work? And to what does Madison need the most? Say, there's listeners who are in college right now or just are paying attention to the space? What do you guys what kind of minds Do you need to show up more than any other?

Josh 47:33
No, think it's necessarily, you know, what, what kind of minds do we need? citizen scientists, listen, I mean, write our info at please reach out to Midas and on LinkedIn, Facebook, etc. We'd love to collaborate, we love your ideas, we love to, to kick ideas off of you. Obviously, you know, from our lab perspective, we're very collaborative there as well, on the Colorado lab, the lab at the University of Alberta is obviously much more restrictive, we have, you know, a federal drug development license there. So the protocols are completely different. And collaboration is much more limited on what we can do. But us as a company, listen, I mean, we support the citizen scientist, as far as the type of mind that we need, you know, when when we need jobs, we'd like to employ everybody. But of course, that's just not realistic. When we need jobs, we post them on on LinkedIn, etc. And they're very pointed, very specific job titles. But keep your eyes out for that. If you are listening and look for, you know, kind of that next step that we're taking from human capital side, and it will happen, so stay tuned.

Lera 48:46
Lovely. Well, thank you so much for your time. I've super appreciate the work you're doing and for the hour that you've dedicated to answer our questions, and there are 1000s of listeners out there who will get a lot of value from this. Thank you, Josh. Thank you so much. I enjoyed it.

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Alex Dorr is the founder and CEO of Mushroom Revival. He launched Mushroom Revival with a mission to revive health with the power of mushrooms.

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