Psychedelic Invest’s second Investor Hotseat live stream event aired live on Thursday, June 9th. Host, Dustin Robinson, of Iter Investments, was joined by Dr. Chris Witowski of Psilera Bioscience. Chris was asked a series of intense questions that kept his energy levels, and his sweat levels, high,
This interview taught us a lot about all of the exciting things Psilera has going on right now. We look forward to following up with Dr. Chris as Psilera continues on its path of innovation and commercialization.
Hello everyone. Welcome to the second episode of investor Hot Seat. My name is Dustin Robinson and I am your host. I’m the Managing Principal of eater investments, which is a venture capital firm that invests in early stage psychedelic companies, including the company we have on our episode today. While there are plenty of media platforms that are covering the psychedelic space as an investor, I just didn’t think they were asking the questions that I was curious about. So we launched investor hot seat with the intention of asking those questions, the questions that I wanted to know as an investor the tough questions that CEOs need to be prepared to answer. Just to be clear, this is for informational purposes only, we are not soliciting investment. And we have the full terms of conditions that we encourage you to go see on our homepage of the psychedelic invest website, we just pulled up those, that legal disclaimer right here. But you can view that also on the psychedelic invest.com homepage as well. The agenda for each episode will be five minutes where our CEO will be presenting that will be followed by 30 minutes q&a, that myself will be asking. And then we will reserve five to 10 minutes for the audience to ask any of their questions. So if you have any questions whatsoever, you do not need to wait till the end, you can just drop them in the comments box. And we’ll make sure that we get to them after I’m done with my questions. So without further ado, I’d like to welcome Chris with Toski, the CEO of Solera. Chris, I’m going to pass it to you for your presentation. And then you’re you’re going to jump into a q&a. You have five minutes and you’re on the clock.
All right. Thanks, Dustin. And thank you all for being here. First of all, I wanted to congratulate you Dustin for a great inaugural interview with Anthony last week with awaken, he has a brilliant accent, I will do my best. I’m a little froggy. But I’m, again, happy to be here. So let me tell you a little bit about Solera. We are a biotechnology company. And we are taking first generation psychedelics things like DMT Dimethyltryptamine, psilocybin and solutions lowson being the other active ingredient from psilocybin and optimizing these compounds. And we’re doing this work in one of two ways, either by formulation, creating ways to deliver these compounds more effectively than what’s currently being done. And as well making small chemical modifications to them, so that we can create better optimized compounds, whether that’s reducing off target effects, like hallucinations, and creating more scalable treatments, we see a major issue potentially with the industry and, and how you commercialize these psychedelic therapies and having, you know, multiple therapists observed the patient over a, you know, four to six hour, sometimes longer treatment. And again, within the United States, the psychotherapy
based treatment protocols are really not covered by insurance companies. So you know, how, again, do patients actually access this treatment. So our platform, our company is really focused on ways to optimize these therapies. And my background, personally, as a natural product scientist, I have my PhD in chemistry, and over 60% of all drugs have really been derived from nature. So what we’re doing at Solera, is just really optimizing these compounds in ways that, you know, I think a lot of others maybe really haven’t taken the same approach.
And, you know, one of the ways that we’re looking to tackle first and indication is social anxiety disorder, anxiety disorders, affects 40 million people within the United States, obviously, coming out of the pandemic. You know, creating social interactions, again, is something that maybe people will be uncomfortable with. These types of afflictions have increased 25%, since the pandemic. So again, this creates an opportunity to create new and innovative ways to really treat people. And our compounds really can be broadly applied across the UK. I’ll say this quite a bit today, but CNS, so that’s the central nervous system. So this covers depression, anxiety, substance use disorder, PTSD, largely these compounds interact within the brain across all of these disorders. So it’s our task as researchers here at Solera to figure out exactly and precisely which of our compounds and formulations work. So I know I maybe have another couple of minutes, but I’ll throw it back to you, Dustin, for the q&a session.
Awesome. Thank you, Chris. Appreciate it. You did a good job of quickly explaining something I know you guys are doing so much. So hard to kind of boil it down into into into five minutes. So I want to start off one of the things as an investor we’d like to understand is the why. So I know you and your co founder, Jackie, you got started very early in this nascent industry. So could you just talk to us a little bit about how you met Jackie, and what really inspired you guys to start Solera?
Yeah, so I’ve known Jackie, Dr. Von somm. for over 10 years, we actually worked on our PhD programs together and natural product drug discovery. So again, working on various related projects, what we’re doing today, she and myself both interacted across various federal forms of drug discovery. Together, we have over 30 years
have drug discovery and development experience. So, you know, this is something that we’ve been doing our entire careers and really just so happened to find ourselves and a once in a lifetime opportunity to do this for mental health and CNS disorders. Um, you know, some of the other ways that we have worked together is actually within the cannabis industry. I was an early employee for a startup back in 2015, brought Jackie into the company and together, I mean, we helped build a multibillion dollar company within that industry. Together, our projects were largely focused on different formulation techniques and how we deliver these compounds to patients and largely focusing on non combustible inhalation, whether it be metered dose inhalers and nebulizers. A lot of transdermal products, gels and patches.
And really having a lot of interactions with patients is something that we took away from that industry and, and really taking that into Solera. Today, and how we think about the end patient first, and what are they going to be comfortable with using?
You know, I think sometimes within the industry, we can surround ourselves with people and maybe an echo chamber a little bit that sinks, everyone is going to want to experience a psychedelic therapy. And, you know, I think broadly, I think maybe we’ll get there but at least in the short term, you know, I think the ways that we can deliver compounds that are more traditionally prescribed, you know, take home therapies, and things like this, that aren’t mind altering that aren’t ego dissolving, I think are things that really can make a difference right away. And obviously, I think this is going to solve some major problems and how we scale these therapies to millions upon millions of people that need it. Absolutely. And the way I think of Solera is kind of in three divisions, you have your your two delivery systems, you have the transdermal patch, and the nasal spray, as well, you have second you have your NCAA ease. And then third, you have your brain platform. So I want to start off with your transdermal DMT patch. So my fund, we’ve seen a lot of different companies looking to develop transdermal technology. We’ve also seen several companies that are looking to develop DMT and other delivery methodologies. What what’s unique about your particular transdermal patch, and why did you decide to use DMT as the compound as opposed to some of the other traditional traditional psychedelic compounds?
Yeah, so why don’t we take the first part, and just say that, you know, sorry about that, need to keep moving here to keep our lights on in the office. Um, I would say, you know, all the verticals of our company, whether that be formulation, whether it be NCS and our technology platform are highly synergistic. These aren’t separate projects, they all intertwine and really wrap around DMT itself. So DMT is the core structure that we are looking to optimize formulation wise, and with our NCD platform. And we’re aggregating all this data within our platform. So again, all of this really is intertwined with our various projects.
DMT is a great compound, it’s safe, it is actually naturally produced in the brains of humans. So it’s obviously there for a reason, and how do we harness and deliver this compound more safely, and more effectively and less invasive than what’s currently being done with intravenous needles currently, so again, I mentioned some of our background, both the founders of Solera are with transdermal technology. So we’ve commercialized develop these products before. So we were very uniquely engrained into this technology.
And something that we’re really excited about, because the anti has efficacy at lower doses of non psychedelic doses or sub psychedelic, for instance. So this has been proved out in in preclinical studies looking specifically at neurons so they can create the neuroplasticity that other psychedelics have, but at lower doses, as well in behavioral studies. DMT is also active for anxiety disorders, depression, as well at sub psychedelic doses. So how do we harness this DMT patch is almost an ideal microdose delivery system in that, you know, we can develop a very low dose sustainable delivery system over multiple days. And it’s something that can ultimately be taken home by the end patients.
without the fear of hallucinations, and a DMT patch, again, kind of covered all of these various aspects. And we’re really looking forward to bringing this product into patients for the first time, happy to announce we are actively filing our ind and hope to do so the next couple of months and, you know, with with some luck and good feedback from the FDA, we’ll be dosing humans very, very soon. And that’s very exciting. So so one thing we talk a lot about on this show is patents. So it’s great to have a technology it’s
Bruce agreed to prove that it’s safe and efficacious. But as an investor, we’d like to understand, you know, what is that moat? What is your patent position, and I know you guys have a very strong priority date on your DMT, transdermal patch. But one of the requirements with patents is that they’re non obvious and inventive. And so from what I understand you guys are using a known compound DMT. And you’re also using a known delivery system. So I like for you to explain what about your DMT transdermal patch makes it non obvious and inventive?
Yeah, that’s a great question, Dustin. So like you said, an early priority date is the first filing date that you have to overview your invention. So for us the the DMT patch goes way back to May of 2020. So really, at the infancy of, of the industry, we really spent, we founded the company in 2019. And spent the first year in stealth mode, just understanding what had been done research wise, understanding the prior art, and where we could find areas where we could patent and create novel IP within our development pipeline. So we saw the transdermal delivery of DMT as being a particular area where nothing else had been done, no one has created similar products, no one has characterized these products, no one has demonstrated the DMT can be even delivered transdermally. So these are all things that we included within our patent application. Again, we created a lot of different prototypes with examples of different adhesive systems, different excipients, all the different things that can increase the delivery of DMT through skin membrane. And this is a very similar approach that we’ve taken in the past both myself and Jackie, in the cannabis industry. And we’re successful there together, Jackie, and I hold more than 10 patents. So, you know, this is something that we’ve really done over our careers. And, you know, without, you know, trying to forecast with the the US Patent Office, the world Patent Office will say, you know, I think we’re in a very strong position to really have issued IP around our DMT patch. Got it. And as you mentioned, you guys are focused on social anxiety disorder with your transdermal patch. Can you talk to me a little bit of why you decided to choose that indication? And also, I’d like to understand a little bit better why you believe your sub hallucinogenic approach will be effective for this particular indication?
Yeah, again, another great question. So social anxiety, like I mentioned, coming out of the pandemic is an area that we think is going to continue to have strong demand from a, you know, a patient standpoint.
Over 40 million people are affected by anxiety disorders just within the United States. And when you look at the current standards of treatment for social anxiety, it’s things like SSRIs, which are really only for chronic use, and not necessarily acute social settings, or benzodiazepines. So I mean, these are compounds that are over prescribed, they have issues with addictive potential drug drug interactions, overdoses. So, you know, both the current standards of care for social anxiety really can be approved upon and have not been improved upon in many, many decades.
So with social anxiety disorder, what we’re able to do in a clinical setting is actually provide very precise ways of monitoring patients that aren’t just the self reported metrics. And, you know, when you look at large doses of psychedelics and the typical trials, you know, the self reported metrics are great, because large doses of psychedelics for many, many people are life changing events. So, you know, of course, self reporting before a psychedelic dose, and after a psychedelic dose, you’re gonna get a huge delta or change between base state and post dose. But with a microdose type patch setting, you really need better ways to to precisely identify what the product is doing. And, you know, what this allows us to do is put somebody a patient with social anxiety and a public speaking event and and really stress them out. And then we can measure cortisol levels, blood pressure, heart rate, with a placebo or with our products. And with these quantitative measures, what we can ultimately do is reduce the amount of patients that we need, say in a phase two trial, if we were doing so self reported metrics, you would probably need 1000 or more patients, but with more quantitative measures, we can reduce that to maybe a couple 100 patients. So you know, really just looking at a phase two trial, we’re able to save, you know, $10 million or more just in the clinical development of that product.
Great and so good. You say, I know you mentioned that you’re just filing your ind. So you haven’t dosed humans with this DMT transdermal patch, but you’ve done some animal work, can you could you talk a little bit about what the preclinical work that you’ve done thus far and what it’s showing.
Yeah, so we’re showing great delivery over multiple days right now is three
At a delivery rate with a patch. Obviously, once we start dosing humans, the some of that might change. But that’s why we are looking for the phase one trial to really inform us for dosage into a phase two.
You know, other preclinical data shows that DMT is active at sub psychedelic levels. Again, it’s an endogenous compound. So it’s produced within the brains of humans and many other animals. So just harnessing a way to get the compound into the bloodstream systemically, and monitor what it’s going to do. So we have, you know, great conviction that this is going to be a product that can ultimately surpass some of the the current standards of care, like SSRIs. And benzodiazepines, and ultimately, I think, can be a product used by many, many people that are afflicted. And just so I’m understanding that the normal psychedelic paradigm that we’re working in is that the psychedelic compounds will be taken at a clinic. But in your instance, you guys are trying to use you know, sub or even non hallucinogenic doses, what what is actual the delivery? Are you expecting that people will be taking, you know, putting on your patch? Right, before they have some sort of social event? Or do they use the patch on a weekly basis? What’s, what do you expect the delivery to look like of this transdermal patch? Yeah, with a transdermal patch, there is sort of an accumulation period for the drug to reach into the plasma in order to have sort of the the sustained benefits. So, you know, what we anticipate in some level is, you know, getting ready to go into a social situation, applying a patch beforehand. And then, you know, letting the patch habits effects. The great thing about DMT is it does have a very short half life. So if a patient wants to remove the patch, once they do so, literally, within minutes, the drug effects will start to fade off. So it is something that, you know, we are designing more for acute settings, as opposed for more of a chronic use. But ultimately, you know, we’re going to let the clinical data sort of inform what’s the best way to use the patch. Got it. Awesome. And so so that’s the DMT, transdermal patch, obviously, a whole lot more questions I could be asking, but I want to make sure we we move on to some of the other divisions that you have. So your new chemical entities. So what you guys are doing, how are your new chemical entities improving upon some of the other psychedelic compounds? And what is some of your preclinical work showing with respect to some of your lead? MCs? Yeah, thanks for asking Dustin, we’re really excited about what our NCS can do. So from the gecko, what we’ve really tried to design is ways that we can reduce hallucinogenic effects in, in these compounds. And, you know, we believe with this, we can develop more traditional take home medications, you know, reducing some of the the clinical dosing, you know, improve access for patients. And we’re really starting to see this play out now with a number of our MCS and preclinical studies,
I would say, with a few compounds that we’ve dosed already, we’re showing that hallucinations only occur at very, very, very high doses, like 1015 times what it would take, say, traditionally DMT, or psilocybin. So this includes a much broader range where we can dose these compounds. And in our preclinical studies, we’re also looking at a number of behavioral tests for antidepressant effects, anxiety, lytic effects for anxiety, and substance use disorder. I will say with with depression, in particular, we’re seeing some very, very promising activity. So the forced swim test is what’s used for any antidepressant in development. So, with one of our compounds, CL 001, we’ve shown that it is more as active as psilocybin at psychedelic doses of psilocybin and psychedelic doses, our compound is as effective without hallucinations. And, you know, this is something that has really never been demonstrated before. And, you know, really to simplify, what we’re doing is we are just putting one atom onto DMT onto Cillessen onto psilocybin, and we can neutralize hallucinogenic effects. And we are creating new chemistry in the process, we have a very, very talented team of synthetic medicinal chemists, Computational chemists, myself and Jackie are, are really working on this project too. And, you know, by placing one atom to remove all of those side effects is incredible. And creating novel chemistry in the process means that we have a myriad of other changes that we can also make on the compound to say make them more orally bioavailable, reducing some side effects that other serotonin receptors which are responsible for heart abnormalities. So
you know, from an IP perspective, these compositions of matter are really, really crucial and valuable for a biotech company like ourselves. And I’m happy to say that we have about 140,000 compounds within our patent application.
Asians and I would say we have a very good claim to these compounds being issued. And just so I’m understanding your NCS correctly with respect to the non hallucination part are your intentions, I’m assuming art so that it doesn’t hit the five HTT to a receptor that is responsible for the hallucinations? Are you looking to essentially still hit all the other receptors that some of these compounds hit? Are there other particular receptors that you guys are looking to maybe not hit with your new chemical entities? Yeah, so five, HD to a is just one receptor. Within the serotonin system, there are 14 or so that are known today. And that is responsible for causing hallucinations, but no psychedelic is specific just to that one receptor. So it’s the term commonly used is called poly pharmacology or promiscuity. So all of these compounds interact with a myriad of glutamate of dopamine, serotonin, Andrew nergic. So we’re trying to keep all that other chemistry the same, just remove activity at one receptor. And, you know, we’ve shown that we can reduce the hallucinations there. And that opens up, you know, a number of possibilities across new indications. So most Psychedelic
Studies, omit patients for history of psychosis and schizophrenia, because agonism or, you know, basically, inducing HT five HT to a effects really exacerbates these inpatients. So just by turning off that one receptor, again, this is really going to open up who we can dose and who has access to these compounds.
Got it. And so, you know, I want to really dig into this sub hallucinogenic dosage stuff, because, you know, our fun, we have a very strong conviction around macro dosing, there has been a lot of very, very strong research, most of our investment dollars have gone towards macro dosing. Solera is actually the only company that we’ve actually invested in from a sub hallucinogenic proach. But we still are developing, you know, our thesis around that as a fund and trying to understand it better and really understand the full landscape as far as other research going on that that is demonstrating any sort of efficacy there. So maybe it would be helpful for why you have such confidence that the sub hallucinogenic doses will be will be effective, whether it be the research that maybe you have done or other research that you think is compelling. Yeah, I mean, first and foremost, I would say our data shows that non hallucinogenic compounds can still be effective in these indications. You know, one of the earliest, psychedelic the first psychedelic compound approved for depression was actually s ketamine and this is marketed by Johnson and Johnson as approved in 2019. So ketamine does not interact at all with serotonin receptors, especially five HT to a the one that we talked about, which is responsible for the hallucinations, but ketamine, and all other psychedelic compounds really do share a common mechanism of action. So ketamine, again, with the same properties of antidepressant effects doesn’t interact with this one receptor. So just saying that we don’t have this one effects. For us, it’s a side effect. It’s an off target effect. It’s something that’s not necessary for therapeutic benefit. So yeah, I would say our data shows this across a number of compounds. There are other researchers who have shown similar effects that you don’t necessarily need hallucinogenic doses or a hallucinogenic substance in order to have therapeutic benefits. I mean, all antidepressants on the market currently, except for ketamine, or non psychedelic.
And ultimately, again, I think it comes back to indication specific dosing. So let’s say something like neurodegenerative disorders like Alzheimer’s or dementia, you know, these types of patient populations likely don’t need a hallucinogenic dose. But we’ve shown with our compounds that we are targeting areas of the brain that are responsible for learning and memory, there are other serotonin receptors that are beneficial in these and our compounds are pretty selective at these receptors. And we do have really positive learning and mood benefits. So you know, we think this is an area where these compounds can be specifically applied. And we’re actually actively applying for grants for Alzheimer’s funding in order to pursue these projects for new indications just outside of neuro psychiatric disorders. But I think when you couple the underlying potential of these two kind of meliorate mood and make people feel better, and if you’re able to get a drug on the market just for that in these patients subtypes of Alzheimer’s disease and dementia, you can then have a product on the market and then dose patients over a longer period of time and see how it’s interacting with them. Is there any disease modification is their learning and memory improving or not getting worse? So these are areas where I think, you know, indications for
cific is going to play a large part into whether it’s a hallucinogenic dose or not. Absolutely. And, you know, I’d like to press on this topic a little bit more since we are on investor hotseat, I’m sure some of our viewers are a little bit skeptical about some of this stuff that you’re saying I’m sure we have a lot of people who are, you know, strong advocates of that mystical experience. And a lot of the some of the top researchers have said that it’s really in that mystical experience where you, you’re able to have that new understanding and kind of rewire your brain and kind of reprocess some of the things that might be causing some of your indication. So are there certain indications that you think maybe the sub hallucinogenic doses will not be effective, for example, with PTSD, where it’s very trauma based, and right now with maps is research with MDMA psychedelic assisted therapy, a lot of it is that you know, that five H to a activity that allows them to, or at least it seems like it’s a five H C, to a activity that allows them to kind of reprocess that trauma and come at it from kind of a different place and think of it in a different way. So are there particular indications that you think maybe won’t be able to be addressed in a sub lucid energetic dose?
Yeah, I think for things that really have deep rooted trauma, or, you know, suicidal ideation, treatment, resistant depression, things that are really rooted into who a person is, those large psychedelic doses can just break someone’s thought pattern with one or two doses. So, you know, that’s something that, you know, maybe a longer micro dosing protocol might be able to do. But, you know, when you look at the effectiveness of what’s being done, it’s, it’s certainly I think, areas like, you know, major depressive disorder, things like that might be better suited for large psychedelic doses. Again, I’m a little skeptical and how you commercialize a product and make that viable over the long term. But certainly, you know, I think the hallucinogenic nature can be beneficial. For some people, it’s just, you know, we’re looking at ways to overcome some of the problems, you don’t necessarily need the large hallucinogenic dose for neuroplasticity. And that’s creating some of these new thought patterns, new neural pathways. And, again, it’s our data and other support that you don’t need a hallucinogenic experience in order to induce neuroplasticity. Got it? Um, so I want to now pivot to the third division, this probably the division that I’m most excited about your computational chemistry platform that you guys call brain could could you describe the development and commercialization flow for this platform? And what makes your platform different from some of the other companies that also have platforms looking to develop NCAA ease? Yeah, great question. Thanks for asking. Dustin. So, you know, we call our computational platform brain so you might hear me refer to it as brain. So let me just explain to you a little bit about what computational chemistry is. So we we have a number of receptors within our brain like serotonin, endocrinologic, etc, that we’ve crystallized these proteins, so we know what they look like in a 3d map. So now we can use computers to then model these proteins and our drugs, they are NCS and put them into the protein to see how well they bind. So instead of having to physically synthesize these compounds, have the biologist put them in the receptor, get the data out. I mean, we can do this very, very rapidly and scale much, much quicker using computational chemistry. So computational chemistry is a newish field in the last couple of decades. But we really have a great team working on this project. We have Dr. Dan Santiago, who actually was trained under that the head of Schrodinger, which is the major Computational Chemistry platform. Dr. Steven Austin is a biomolecular physicist who allows us to do things that no one else can do. And also Dr. Bryce Allen, who is a world renowned data scientist, who literally wrote a book on it, of how to incorporate data, and he’s allowing us to incorporate real world evidence. So we know a lot about serotonin receptors, we know a lot about psychedelic drugs. So incorporating this data into the platform makes it much more reliable, much more predictable. So again, computational chemistry, typically what you have is a static receptor. And this is something that most people will put their ligand in, okay, it binds you get a result. However, this receptor does not exist like this in the body, there is water floating around it is actively moving. So we’re what we’re doing is actually using really physics based technique to solve ate the protein in a more natural state, allow it to move around and putting our ligand in there. So we’re not just seeing how well it actually binds. But we’re also seeing functionally How does it work? So this provides us insights into the mechanism of action. So we actually have novel insights that no one else has created just by doing these types of studies and we’re able to optimize compound on an atom by atom
on bases on a very, very small scale that, again, traditional techniques don’t allow us to do.
Absolutely. And I think some of you guys who are listening may understand why me and not as a scientist, I’ve brought onboard to my team, some of the brightest scientists to help me understand some of the some of the things Chris is describing. So I know enough to be dangerous. But you know, this this industry, it’s a very complicated industry to invest in. Obviously, it’s similar to biotech in a lot of respects, but you kind of have the additional aspect of it being psychedelics, that just creates another level of complexity as an investor. Um, so it seems that your your brain platform has a ton of potential, we’ve looked at other companies looking to build platforms as well. But these platforms generally are very expensive to build out. So can you? Could you explain to me where exactly you are in the development of this brain platform? What else still needs to be done? And and how much do you think it will cost to really build out a truly robust platform, you don’t actually Dustin, this computational platform in terms of cost efficiency is much, much greater than then what we’re doing, say, on the synthetic side, or on the clinical side. So you know, this, you know, cost input versus ROI is massive on this computational platform. So again, I mentioned, you know, our ability to scale with this is much greater than we can with traditional methods. And this will put your your costs into a better perspective. So let’s say we have a million NCS that we want to screen. And actually, with our computational platform, we can screen 1500 compounds per hour. So if we wanted to go through those million compounds, it took us about a month to get all the data and aggregate it. But in a traditional sense, other biotech companies doing the synthesized and test method, I mean, it would take them a decade or longer 10s of millions of dollars to do so we’re saving both time and money, by using this platform the way we are,
you know, your question about, you know, what do we need, in order to scale this even better? You know, again, the cost efficiency here is really, really great, you know, I would say, with another million or $2 million, we can really incorporate in a lot more biological data, and this is data that we’re generating on our NCS, we can add to our head counts, we can, you know, really process this data much better. And, ultimately, what we’re doing now is, we have a large data set, I mean, we’re actively collecting data, that computer so my left here, humming away, and, you know, we’re now looking at pattern recognition using AI, you know, advanced machine learning to, to look at some of these different interactions, so that we can now be able to predict better predict, you know, which compounds are going to be useful for specific indications. And, you know, this really is the next frontier and something that we’re really, really excited about. Got it. So I want to move into kind of your commercialization strategy, like you mentioned, your brain has already developed, you know, sounds like hundreds of 1000s of different compounds, and you have your, your DMT patch, you have the inter nasal delivery system. So, from a commercial a strategic commercialization perspective, are you looking to take all these compounds through through, you know, full clinical trials? Or do you expect at some point that you’ll likely license these compounds out and partner with someone else? And if so, how far down the clinical trial phase? Do you plan to take these various different programs that you have?
Yeah, great question. So you know, we really are experts in drug discovery and development. So that’s really our sandbox. And that’s where we like to play. You know, our goal from all along is to develop a very unique pipeline of formulations and compounds and prove these out to a point where now, this is an asset that others would be interested in acquiring or partnering with us to take forward into later phases of clinical trial. This is a traditional way that biotech companies operate to bring in non dilutive revenue without commercializing their own drug products, you know, as you and your listeners probably know, I mean, just to commercialize one drug, assuming everything goes right, you need at least $100 million to do this. And then you have to have Salesforce to commercialize it. So you know, that’s obviously a lot of risk on the company, to then, you know, try to push that forward. So with the model that we’re using, really de risked the pipeline quite a bit. And we have a number of ways that we’re doing that, say, with our computational platform,
you know, I would say we are in active discussions with a number of pharmaceutical companies, the interest there is real with mental health with CNS. And these compounds, especially ones that are differentiated from, you know, say pro drugs or other deuterated compounds, I would say there’s there’s quite a bit of tangible interest there.
I would say we are very close to actually announcing our first pharmaceutical partnership and one that we actually hope to do very, very soon. So we’ll keep you in the loop as we finalize this agreement. Very exciting. And you know, I think it’s just great for the industry to get better.
Big Pharma involved, we saw the deal that Otsuka did with mindset where they licensed out a couple of their femme families of chemical entities. And, you know, whenever I hear Big Pharma getting involved, I think it’s just a very positive sign for the industry. So you kind of touched on, you know, how you know, some of the expenses, it’s very expensive to do some of the different things you’re doing or like that you’re planning to, hopefully outlay sense eventually to kind of bring down some of those costs. But with these three divisions, there’s certainly going to be, you know, a lot of costs involved. So can you tell me how much capital have you guys raised thus far? And what are the main? And what do you think you’ll need to really hit your next milestones? And what are those next milestones that you want to hit? Yeah, I mean, I’m extremely proud of how capital efficient we’ve been so far as a company, you know, we’ve, we’ve stayed very lean, we have seven full time employees, six of these are scientists, Masters or PhD level. All of mais, most of these are scientists and researchers. You know, it’s one of the reasons that we’ve stayed a private company just to not incur a lot of, you know, overhead costs, IR costs, you know, costs of going public accounting, those sorts of things kind of add up and really distract what we need to do, which at this stage is really innovative science and research and development. So to date, we’ve raised just a little under $3 million. Some of this is a non dilutive actually a grant matching program here with the university, we are actually affiliated with the University of South Florida, we’re a private company, but we work within the incubator program. So again, we have access to a lot of resources and equipment, which keeps our overhead costs really low, and allow us to operate very efficiently and generate the data today, which with only $3 million, I really doubt there’s another company in the space who has been as efficient and as productive as we have. Um, you know, with that being said, like you said, there there are, you know, aces to bring in more capital to accelerate our projects. And, you know, again, we are a private company, so I won’t get into any specifics.
But I would say within the next couple of years, we are looking to bring in between five and $7 million.
And this will accelerate a lot of our programs. I mentioned the IND filing for our DMT patch, you know, a really big milestone for us. And getting into a phase one is a big milestone for any company is first inhuman dosing. Really excited about that project will also have our our NC E program. So we already have tenancies that are synthesized. Some of these are still undergoing testing, looking at various behavioral tests for depression, anxiety, substance use. So over the next 12 months or so we’ll have a myriad of data on these new compounds. I do mention with patents, with our early filing date, we are looking at the beginning of 2023. And we anticipate to have multiple patent issuances, which I think is going to be a big milestone within the industry, because a lot of people are really going after the same things and kind of waiting for some of those to flesh out until you really see kind of who are the emergent leaders within the industry. So we’re very confident in where we stand with IP. And, you know, I think over the next six or eight months, we’ll really you know, have many patents in hand. And lastly, with computational platform, I mentioned how cost effective this is, we’re going to continue developing this, you know, potentially adding to our headcount or other ways to to really expand what our capabilities are in terms of data processing, finding new ways to screen these compounds. You know, we have 140,000 compounds and with the the application of computational chemistry, we’re going to have a very robust data set not looking at our compounds, but others as well. And really matching these two ways where we think we can be really effective in the clinic. Absolutely. So I have this one more question. I wanted to let the audience know, feel free to drop any questions, we’re gonna get to them and in just a minute after my next question, so if you have any questions, drop them in the comments box, and we’re gonna get to those in just a minute. So last question I want to ask is, is about your collaboration with Nida? So a lot of the viewers may not know what NIDA is. So could you discuss a little bit about what NIDA is and what you guys are looking to achieve with this collaboration?
Yeah, so NIDA is actually the National Institute on Drug Abuse. It is a government agency who typically looks at the negative effects of, you know, maybe drugs of abuse. However, we we’ve struck up a partnership with them, and we are looking at, you mentioned our DMT intranasal formulation. Again, this is a way to overcome the intravenous dosing of DMT, which is commonly done. So we’re going to actually have top line data for our intranasal formulation and animals very, very soon. As well, we’ll have ind enabling studies with them looking at the pharmacokinetics, the metabolite profile, and some other pharmacodynamic
metrics for our two LEED NC EAS that we select out of the 10 that we’re currently gathering data with. So again, you
You know, we’re striking up partnerships with government. You know, I think our data is very solid and very robust. And, you know, I think the validity of what we’re producing whether would be with pharma government, universities, I think is really, really special. Awesome, you survived my questions. You did a good job, Chris, we’re gonna we’re gonna see how you deal with the audience’s questions. So I’m gonna go to the first question from 420 RX, she says, Will the transdermal approach bypass cardiac cardiac or rhythmic issues being triggered?
So, I mean, most of those cardiac issues are what we call a dose response. So the lower the dose, the lower the cardiac risk, the higher the dose, the Generally, the higher the blood pressure, the higher the potential for any of these cardiac issues to occur. So, you know, again, looking at a low dose, you know, I think we’ll be okay. But ultimately, you know, we do need that human data to kind of support the hypothesis there. Got it. We’re next we’re gonna go to Adam T, he says, how many milligrams with a pout patches be delivering over how long the body load of DMT can present even at micro doses? Have you guys observed this at all?
Yeah, so again, we are a private company. And, you know, trying to keep some things close to our chest, I would say, the dose ranges that we’re looking at for the patches are phase one is going to be selecting two doses of more of a lower dose as well as a higher dose to just look at, you know, whether maybe those cardiac issues are happening at higher doses, you know, whether we’re starting to see audio or visual disturbances at either the higher dose or the lower dose.
So yeah, I think we have a pretty robust handle on our phase one, trial and design. And and really, you know, first and foremost, it’s just really coming out of point of, Is this safe? Is this tolerable? I mean, I think one of the major things that we might be concerned about is maybe the irritability of the application site, but from our study so far, you know, we think this is going to be a very safe, very tolerable delivery system. Great, we’re gonna go to Jamie Jamie philippou Z. Her question is, have you done any combined therapies using CBD with a psychedelic
um, we personally have not. I am aware that our other
studies looking at this currently, you know, CBD is actually a pretty great anti inflammatory compound within the brain. So there could be potential synergies between that and psychedelics, psychedelics themselves, again, are pretty potent neuro anti inflammatory compounds. So, you know, whether it’s one combo or one drug or a combination of others, there could be potential. I will say though, from a an FDA standpoint, CBD actually is an approved drug, which makes things a little bit easier to work with. But when you start combining drugs, there’s more variables to contend with more potential side effects, you know, safety issues to contend with. So, we are trying to stick with a typical one compound one target approach. Absolutely. You run into all sorts of complications with combination therapies, but I will say one of our portfolio companies, we Sana, they’re doing a macro dose of psilocybin followed by a combination microdose of CBD and psilocybin. So if you’re interested in learning more about that kind of methodology, you may want to look into we sauna health. Next question is with Elaine Kim, she’s asking how would you consider at home sub hallucinogenic dosing? Versus the massive DM DM N reset theorized to cause neuroplasticity?
Yeah, so I’ll say for our NCAA ease, we have not looked at neuroplasticity yet. I do believe that is an area that we are going to investigate in the near future. I mean, we know the large psychedelic doses they’ve done fMRI. So, this is a way to look at the blood flow and brain and and create those different you know, blood flow interactions, the neuroplasticity type events. You know, other researchers have shown that non psychedelic compounds are sorry, non hallucinogenic compounds can promote neuroplasticity. So
that is sort of the the mechanism of action of that’s currently ascribed to psychedelics. I would say some of the work that we’re doing with our computational platform, maybe you don’t quite need the neuroplasticity at the high doses of psychedelic effects that you do. You know, our current hypothesis is it really is sort of the poly pharmacology it’s not just five HT to a, you really need other receptors at play in order to have these beneficial effects and we’re definitely seeing that on our end with our data. Got it and Elaine Kim had another comment. I’m not sure if this was just a follow under previous one but she asked about chronic dosing, medical supervision etc.
Yeah, again. I mean, once we get into the clinic, we’ll have much more information about this. You know, again, our goal is to have take home medications that people can take, without we’ll call it sub perceptual dosing without hallucinogenic effects. You know, our compounds have a very low abuse potential, we have done some studies preclinically to show, these aren’t activating brain, parts of the brain that are responsible for addiction and addictive potential even much, much lower than we’ve seen with psilocybin. So again, I think our paradigm is really starting to play out that we can develop non hallucinogenic compounds with targeted CNS activity. Got it? This is like a fire round, we’re firing a bunch of questions. So we got we got Rachel Teaneck, she’s got, she says, any consideration for pharmacogenomics and development of these pharmaceuticals?
A really great question, it’s an area that we are actively exploring. And it’s one of the areas where neuro psychiatry really is lacking. It’s just the biomarkers, how do we look at patient populations? Who will respond better to treatments there are some people that are looking at this specifically for five HTT to a, you know, people with those receptors with large doses are going to respond well, because they have a lot of receptors, but again, not looking necessarily at that paradigm. You know, how can we look at more specific, physiological or or biomarker based approaches to develop these compounds? It’s an area that we are again, actively exploring, and data that we can aggregate into our computational platform to make it more robust and more predictable into the clinic. Got it and for 20 RX is asking what classifies as sub No, is it no visual disturbance as opposed to non hallucinogenic?
Yeah, it really depends on the dosage. So what I say our compounds are entirely non hallucinogenic, or psychedelic, you can’t really ask a mouse if they’re hallucinating, right? So you look at the head Twitch response. So this is something that is very correlated to human dosing, you basically measure how much the mouse is heads twitching. So we are we do see some head switches at very, very high doses, we’re talking like 100 200 milligrams per kilogram. I mean, these are way, way out of, you know, what we consider a typical, you know, therapeutic dose. Um, so at much lower doses, say, like, 10 milligrams per kilogram, these compounds are non hallucinogenic. And they are, you know, very beneficial for mood for things like anxiety and depression. Absolutely. And I’ll just point out that, you know, the animal head Twitch is something that has been used a lot. But of course, we still need to do human trials, right, so So animals don’t always get it, right. So we feel, you know, I know Chris is very confident that these are non hallucinogenic, or even sub hallucinogenic. But really, I kind of just warn the audience that in the industry in general, that you know, we don’t want to be overly confident with some of the animal research, it’s great if you’re getting not no head twitches is certainly indicative of not having a psychedelic experience. However, it’s also not definitive, that that will be the case in humans. So we’re gonna
one one comment to that, and maybe this is a novel insight for the hot seat. So one of our compounds or sorry, one related compounds, what we’re developing, has been dosed in humans for, you know, decades and has been shown to be non hallucinogenic. So that gives us more confidence that once we bridge into humans, we’ll continue to see non hallucinogenic responses. That’s great. Yeah, humans is what we want to see as investors. So so next question is from perseverance, lifestyle. She’s asking, you have so many exciting divisions inside your organization? What communication software do you use internally, to keep the teams connected and on the right page at the right time?
Yeah, so largely, we use the Google workspace to aggregate all of our data, all of our communications. You know, on the laboratory side, we use a software called bench Ling. And this is something that is actually compliant with FDA standards. Again, we are working with scheduled compounds. So that’s something we definitely have to keep on on good record. So it’s compliant with that it aggregates all of our data keeps it on the cloud. So you know, let’s say, God forbid, there’s something that goes wrong, or a lab notebook isn’t lost or misplaced, or, you know, gets wet. You know, we still have that data in the cloud. And, you know, that’s something that we can pull back, we can search for specific compounds, specific dates, even classes of compounds data associated with those compounds. So
yeah, it’s obviously a good question. Yeah. And the next question we got from Darren yell W. Essentially, he’s asking any particular skills needed to get involved in the psychedelic indie
straight, I guess, you know, it depends on which company you’re kind of working with. But I guess, Chris, I guess another way to frame the question, are you guys hiring? And what kind of skills? Are you guys looking for in the people that you’re bringing on board? Yeah, I mean, we’re always open to people with specific skill sets. But I would say in general, you know, having a neuroscience background or psychology background, depending on what type or what sector of the field you want to get into, I would say in general, right now there is a great need for for certified therapists to, to actually facilitate these treatments. There are a number of trainings going on, say at the University of Wisconsin, Madison, who is actually developing a master’s program. So they actively host the MDMA trials, the psilocybin trials, so you’re getting hands on experience with the patient. And these are protocols that I think are going to be pretty widespread and things that you can plug into? Well, I mean, there are, I think, map says, they’re going to need 30,000 therapists by 2030. And, you know, we are far short of that. So, you know, if that’s an area, I would say, there’s going to be, you know, a lot of opportunity in there. For us, you know, we are focused on, you know, hardcore science and neuroscience. So those are the types of people that we’re looking for internally. Yeah, and I always try to, you know, inspire people to try to get involved regardless of your background. I mean, I’m, I’m a, I’m an attorney, also a licensed CPA, I’m coming at it from an investment and a legal perspective. But all these companies are businesses, right, they need CFOs. They need assistance, they need account managers, they need, you know, different aspects. So certainly, it’s great to have kind of a science or a medical background. Certainly, there’s a huge need for trained therapists to deliver some of the psychedelic therapies. But also don’t be deterred. If you don’t have any of those particular hard skills. There’s there’s obviously opportunities for everyone. Adam T’s question when you mentioned DMT Are you guys referring to and then DMT or five me up? Yeah, and and Dimethyltryptamine. So the non methoxy compound that is the compound that we are focused on. And the follow up question from Adam T. Why did you guys decide on DMT formulation you ended on. So DMT is an endogenous compound produced in our brain, it is active at lower doses as opposed to other psychedelics. So this was done in comparison to psilocybin, ketamine, LSD, I think, five methoxy DMT as well. And it was the only compound to have the neuroplastic effects at lower doses, as well. DMT just so happens to be almost an ideal transdermal drug, having come from the cannabinoid world where these compounds are very oily, they don’t want to get through the skin, d and t is particularly good as very small molecule and getting through the skin having water solubility. So those are types of things as a formulator. That makes it really, really great.
Got it? And I think that is the last of our questions. I want to thank the audience for heating up the Hot Seat asking the questions that you asked Chris, thank you. You survived the hot seat. You did a great job. I really appreciate you being on the show. And hopefully we can have you on in the future as well. We’d love to do so. Thanks, Dustin. Have a good one, guys. Bye. Take care.