There you go. Hello. Good afternoon. I think we're in the final session of the day, so I'll try to make this brief so folks can get on with their evening. Optimi Health is a Princeton, British Columbia, not to be confused, I've been asked, with Princeton, New Jersey, located company, with offices in Vancouver as well as La Jolla, California, which is a recent addition, including myself. This company was started in 2020 as a company that was producing psychedelics, specifically natural psilocybin. The space at the time was uncertain as to which way it was going to go. The founders were in the cannabis business, which somewhat makes sense given the Canadian lineage.
It was founded by the Wilson family as well, which was the Lululemon founders, as well as another family that ran a company now called BC Green, which is one of the larger cannabis companies. This space has clearly gone a completely different path, and as a result, there's a bunch of fallout over the course of the last five, six years. I was an interested investor in this company along the way, have been an investor pretty much my whole career. Ended up finding that once we got into this year's timeframe, you had a number of things evolving, which led Optimi down a path of producing the natural psilocybin that they were in Canada for Special Access that then went to Australia, potentially then gaining distribution in both Canada on a broader basis, as well as the U.S.
As a direct-to-clinic psychedelic manufacturer, we are in market today, which is unusual. We currently have distribution in Australia, as mentioned, which opened to clinical use in 2024. It's gated. It's gone quite slow. There's 26 clinics we're currently in in Australia. That should go to about 100 over the course of the next year. Still small dollars. We're talking about clinic with maybe two therapists or clinicians times two patients per day. You can run the math. Australia is definitely focused on gaining broader access, but it's still limited market generally. But what it looks like is effectively the largest clinical trial in the world for natural psilocybin. What's happened now is Canada has something called a Special Access Program, which is very difficult to gain access. You have to lobby your politician, then submit that to your doctor if you've tried 10 other things.
As a result, there is now legislation pending as of June that was proposed by a conservative MP that said, "Let's take that relationship from the government to the patient, to the doctor to the patient." That legislation could end up fast-tracking a bit more quickly even here in the U.S. for a variety of reasons we can discuss here in a moment. As a result of that, we bought a phase II trial for natural psilocybin recently, and we also bought a phase III MDMA trial. MDMA, as folks may know, is a 100-year-old formulation. As a result, you've got Resilient, formerly Lykos, who submitted to the FDA two years ago, botched that submission substantially. It's backed by Antonio Gracias, the whole Elon Musk crowd.
They have resubmitted recently quietly, and there are actually some rumors that, and I cannot say if they are valid or not, that Trump is trying to get potentially might be MDMA rescheduled prior to the midterms even to get a win on psychedelics, which sounds far-fetched, and we are not banking on that by any means. That Trump executive order in April lit a fire under many different agencies, including the FDA, including, of course, HHS, where RFK has been a proponent of psychedelics since inception of his term. Now even the DEA is thinking through the lens of, okay, what do we need to do here, right, to actually accommodate and get to a place where psychedelics could potentially be rescheduled to Schedule 3? Not broadly, but perhaps in a bifurcated manner, which we will talk about here in a moment. We are vertically integrated.
We literally grow mushrooms in a GMP vaccine-level facility in Princeton, British Columbia. We have identified every possible species, which most folks focus on cubensis as we do, and then multiple strains, literally hundreds of strains. As a result, we have gotten down to a singular strain that we have then extracted, and then put in capsule format that then is then shipped globally for either research purposes. If you are in the U.S., you are a research group, you have a DEA license to take in Schedule I substances, we can correspondingly ship you product. In the U.K. it is the same, pretty much around the world, and then, of course, Australia. It is through, in Canada, something called a Drug Establishment Licence. We have been through Health Canada’s process, and at this point, they are actually asking us for guidance because in Australia we provided the same.
As a result, we have a couple markets perspectively opening, we will see here in the next year or two. We, of course, serve a major market of treatment-resistant depression and PTSD, which in the U.S. is obviously quite large as it is in both Canada and Australia, as well as globally. There are many other indications. If anyone in the room has had any experience with psychedelics, there is a whole pathway, in fact, that will probably end up being an indication of the psychedelic street around addiction. In fact, the founder of AA used to advocate mushrooms as a way to reduce your dependency on alcohol because it has that effect. It is interesting that there are many indications that could further expand that market. I wrote up a thing on LinkedIn and I said, "Are psychedelics the GLP for the mind?
No one knew GLPs were coming. They hit the market. Now they are the biggest drug in the world, and you could end up in a scenario where everyone with any, from anxiety, depression, through dependency, PTSD, et cetera, could end up realizing that this is that nature's elixir that gets them to a better spot without a dependency on a daily or weekly or monthly medication. It only requires one, two, maybe three doses, and you have moved on. That is frankly why the drug companies do not love it, because they want you dependent on their drug for a long period of time. It would be our preference, and we are probably the do-gooders and antagonists in the space. We are backed by a billionaire family, so they have made their money. They are more focused on providing access.
When we talk through the lens of our experience, people are usually surprised that in Australia, for instance, we have had zero adverse effects. Folks have generally had a great experience. Sometimes it is not that effective because their neurology and physiology does not take in the medicine the same way someone else's might. We also are huge advocates of a guided process, right? This is what the FDA has been specifically focused on. In fact, the hearings they had in September that we attended, they were focused almost exclusively on how you administer psychedelics. They had a number of the state program providers in those hearings walk through that on a pretty rapid basis to give them general discovery around what is the best way to go.
The VA has gotten quite active, which as folks probably know, there are 6.4 million vets in the U.S., 200,000 apparently qualify for psychedelic treatment. They are going, which is why the Ibogaine Initiative, frankly, made it to the top of the stack. They are going to Mexico, Costa Rica. They are going to places they should not have to gain access to various psychedelics. The number two at the VA, a guy named Andrew Gradison, has pretty much made it his initiative. He said, "Listen, we did not get it right with ketamine. We are focused on how to get it right for vets with psychedelics. We have all the facilities around the country." In San Diego, where I live, it is a massive military town. They have a huge hospital.
He is like, "We are trying to carve out space in our facilities so someone can go through that corresponding four to six-hour therapy session where you integrate psychedelics and correspondingly come out on the other end with some form of relief, which depending on your corresponding indication." So you have got a lot of global optionality on rescheduling. Our huge differentiation, and we focus primarily on natural psilocybin via Health Canada. We have license to potentially produce any psychedelic, including LSD, any DMT alternative. In fact, Ibogaine is actually not Schedule I in Canada. When Trump's initiative went forth, we already had the APIs under review. It is a bark, if you are not familiar, from Iboga, and then there is a number of other APIs within that formulation. We just fast-tracked that program, and we said there is cardiac risk associated with Ibogaine.
We are not making a judgment on whether that psych is better than another, but just given it is not nearly as far along as others that have much lower risk profiles. We went ahead and just proceeded with the plan to manufacture. By year-end, for largely research purposes only, we will have Ibogaine available for all the. We get literally a call on Ibogaine every other day, just given that Trump initiative. So we figured why not at least offer it in some format to folks in market. Supply to patients today, it is an extract, as mentioned. We also produce a microdose of the same, MDMA and then Ibogaine, as mentioned, in British Columbia. We uplisted. We can talk about the stock here in a moment.
As you can probably tell, our CEO's not here because literally we're so operationally focused and just given the capital source of the company historically, we were initially CSE listed, and that was pretty much for Canadian regulatory purposes. Now we're U.S. listed for U.S. regulatory purposes. So we're the primary owners of the stock, the contingent of the families, plus investors like myself own over 50% of the company. It's been an interesting ride on the NASDAQ thus far. I was not an advocate. I was actually saying maybe I should go private. At the end of the day, I think on the margin, once I'm a U.S.-listed company, that does help. Obviously opening a U.S. presence down at a biotech hub like La Jolla is not a bad idea either. So huge market as people may know.
It's obviously about a tenth of the size in the corresponding markets I just mentioned, but Canada's an interesting one, given our relationship with Health Canada, how things are trending. We could end up being a significant market player over the course of the next year or two, depending on how fast the parliamentary system works through. What's interesting is that they don't have the same attendant agencies. They rely on the FDA primarily for drugs that make it to market in Canada, as is a lot of the rest of the world. Cannabis, they screwed up, frankly, as a country. Now you've got Carney in power, and he's effectively trying to bring innovation and industry back to Canada, given the tariff war.
What we're seeing is, well, this could be a market that Canada wants to be first in market in socialized medicine, so it's of course then covered, which is a big deal, which we could talk about relative to the state programs down here, which are not. So that's literally the bottle and capsules that our product comes in. The cost to the patient is CAD 300-C AD 500 depending on dosage. That's substantially less than what Compass or any of the other corresponding companies are likely to charge for an initial dose of the synthetics that are currently being developed. In fact, Compass has said point-blank, they're not going into Australia because our product's already there and it's effective, and there is no way they can compete on price. The more expensive aspect of any psychedelic treatment is the chair time.
It's the therapist guiding you through that process, and that is where insurance coverage is really a requirement because it becomes unaffordable for most folks. So in the state programs, you're not covered by insurance. So you have a number of non-profits, for instance, Heroic Hearts is a great one here in New York, where they will fund a veteran's journey through any one of those state programs so they don't have to come out of pocket, the CAD 5,000 or CAD 10,000 or maybe CAD 15,000 that the journey might cost. MDMA, as mentioned, is interesting. We'll see where Resilient goes, but if that somehow is rescheduled to Schedule 3 here in the near term, we would likely end up being a supplier because there's plenty of illegal MDMA factories here in New York.
It might end up being like cannabis and a lot of them convert, but those cannabis providers ended up being very poor operators. We have a vaccine-level facility that is effectively producing MDMA in its actual format as intended. These are the trials, as mentioned. This is going to cost us more capital than we currently have. We went ahead and did a very cost-effective, relative to what an ELOC usually costs, with our primary shareholder, which is interesting because ELOC providers usually just want the fees associated. He is one of the larger holders of our company, our stock, was the lead investor on the small deal we did to uplist to NASDAQ, and said, "Listen, if you guys find that this isn't for you, feel free to cancel any time.
Go to a proper secondary." We also did the ELOC because we are also buyers of our own stock, so if we are going to buy stock, we would like capital to go to the company. So we figured, why not, at least. So those trials will require more than the CAD 9 million or so we have. Again, the CAD 15 million was about doing the minimum and avoiding dilution, and there are some restrictions around insiders participating in a NASDAQ uplist, as you are probably familiar. So we were restricted on how much we could participate. As mentioned, vertically integrated cultivation sourcing, that is a big deal. If you ever had any experience trying to grow psychedelic mushrooms, it is a bit of a challenging exercise.
To get to a specific species and then strain, and then consistently grow it, I sometimes equate it to a great sourdough starter.
You just need to have that be consistent every time so that you have the same end result and the same product every time. So our Chief Science Officer is a chemist, which makes sense, relative versus a PhD or MD, et cetera, because he has effectively gotten to a point and we have had it tested throughout various organizations, and it is remarkably consistent, and it is a natural product, which is interesting because that is hard to do. You are growing a plant for all intents and purposes. We go through the extraction API, which stabilization with respect to API specifically, that we further add to the alchemy, the formulation, and then of course, quality control and release, and then export and dispensing. As mentioned, this is all vertically integrated within the Princeton facility. It is an established commercial process. As mentioned, Spravato is a great example.
You got 5,000 ketamine clinics doing some sort of generic compound. Who knows where they are necessarily getting the corresponding APIs for that particular compound. So Spravato came along, initially didn't have market reception, and then it kind of took off when people had. Ketamine is interestingly not actually a psychedelic, it is an anesthesia, but end of the day, people have had some positive effects. But that is a great example of what might happen to Compass's drug when it is potentially approved next year. But behind that, there is still a massive generic ketamine market, and we are effectively not even a generic. We are a specific natural psilocybin strain that has followed this corresponding process.
So it is an interesting market and theory for generic ketamine is far larger even than the $2 billion that Spravato has produced. So in Australia, as mentioned, exporting from Canada, local pharmacy delivers medicine to a clinic.
The patient receives his treatment at the clinic. We are now being reimbursed in Australia, or sorry, the patient is, of course, being reimbursed for all that chair time plus the drug itself. It is a great case study. As I said, it literally looks like the largest clinical trial in the world for natural psilocybin. Global scheduling is underway, as people may be familiar. You have Schedule I. It was a 1970, 1971 accord that basically said all psychedelics are Schedule I globally. That has been now over the last 50 years, tested and retested by every academic institution under the sun that has basically said this psilocybin specifically, non-addictive. It has had no significant adverse effects, no deaths that could be attributed to the actual product itself. It has to do with sort of attendant psychosis, et cetera, or self-harm.
At the end of the day, it is less harmful than your average aspirin, literally. You look through that lens and you say, "Well, what is the FDA really trying to protect us from?" We have said this in the past. It is about the traditional process that they have had in place for many years, which the medical universe has adopted, which tries to get you to the quickest, most efficient method of whatever that drug is, whatever it is treating, and the corresponding indication it is directed. For psychedelics, I think folks have recognized it is a different method of delivery, and it is also a different intention. As a result, neurology is the least well-known amongst all the corresponding medical specialties, and I think even neurologists, psychiatrists, et cetera, will tell you that, and they are learning more every day.
I think everything that was in the 1970, 1971 accord has effectively been debunked, and we are now in a scenario where the broad-based medical universe is starting to adopt and adhere and frankly promote the potential for psychedelics broadly, both here in the U.S. and globally. Trump is obviously a huge advocate. He is also not a big fan of incumbency. The FDA has created a lot of incumbents. Eli Lilly bought AtaiBeckley, a major psych company, for $2.8 billion several months ago, so they clearly know it is pacing this way. The prospective bet, I suppose, you would be making in making an investment in Optimi is that it is broader access and that natural psilocybin ends up being rescheduled from one to three. Possibly, in fact, the NIH in 2018 suggested that psilocybin, natural psilocybin specifically, went from Schedule not one to three, but Schedule IV.
That is broader access, even less restricted because of the lack of any harm and the non-addictive qualities, which are some of the conditions of you being Schedule I. They just do not apply, and Schedule IV is just a less restrictive category. A lot has happened. This Thomas’ Bill I mentioned, it is named after a patient who died after advocating for Special Access Program, being denied. As a result, there is now an MP sponsoring that bill on the conservative side. When that bill came out, just given the Wilson family connection, we got a call immediately from that MP just to understand more. He asked to come see us. We originally had a lunch scheduled in Van.
Then he said, "I'd really love to come see the facility." So he took the three-hour drive to Princeton and took a whole full-day tour in September, just a month ago, of the facility. And he said, "Listen, guys, there's nothing more I'd like than for this bill to be hijacked by the liberals because this is not a partisan issue. This is a patient issue. This is our constituents who are asking us for access to psychedelics broadly." And you, at this point, are the largest and leading company in the space in our country, so it makes a lot of sense. FDA, as mentioned, had some hearings in September. They're having some more hearings on botanical. I just want to clarify, we are not following a botanical pathway. Seems like we might or should, but just given the extraction process, it does follow the traditional FDA pathway.
So those trials we've got are Canadian trials, just to be clear, and will convert. What happens in that scenario is you can take the data from that phase II trial and then apply it to phase III in the U.S., and you can actually still run those trials in other countries, which we will continue to do so in Canada. So we will be potentially, if those trials go as planned and we move to phase III in market, perhaps sometime in 2028 or thereabouts. But again, we are following that pathway that has been set by the FDA to adhere to all the corresponding components. New Mexico just moved toward general availability for medicinal purposes, in addition to Colorado and Oregon, as folks may know.
Psychedelics are also decriminalized in a few places, which doesn't really mean anything because then it's just people going to go grow them on their own, is really what. So in Oakland and Santa Cruz, California, in Seattle, which decriminalized everything. As a result, those state programs, we've talked to all of them. We have great visibility into them. And they said, "Listen, our issue is we can't afford to run these service centers because we're trying to subsidize pricing to create access," and they can't even guarantee that the supply is necessarily going to be there. And then they have to get folks within the world of psychology and therapy to act as guides, which is an expensive proposition. So they too would love to see federal regulatory shift so that insurance would then cover those sessions.
I'll speed this up because we're probably almost out of time. It's definitely compounding the global regulated access across all these countries. We're now in the Czech Republic talking through with a various distributor that could potentially be a partner. Switzerland's kind of a medical tourism space, as people may know. The U.K. is running trials. In fact, there's another company that just raised money from four biotech funds that's running a phase II trial in the U.K. with our product, just to give you an idea. So we are seemingly the default in natural psilocybin, if you want to think about the category. We just put the comps up there so people understood where people are. There's a great website, too, called Psychedelic Alpha, if you're interested, that has every one of these trials, where they're at in phase. And of course, Atai was just recently purchased.
As you may know, Definium is focused on LSD. You've got all the corresponding different psychedelics that folks are centered around. So ability to thrive in various scenarios. It's a, what, a CAD 20 million, CAD 25 million market cap company. It's like the great, from our perspective, obviously, we're the core investors, so we have long-term conviction, but it's just a great option. Why would you own it? If you own Compass, you own Definium, you own any one of the names in this space, how would you not want to own some piece of our company? It just seems obvious. We're doing the circuit, talking to the analysts, doing the investment banking route, all the things you would imagine. You've got some scenarios where the U.S. could, things could just derail, right?
You could just go bifurcated, and it could just be Compass for two years, and you could just wait on. That's why we got in line at the FDA with the phase II. Even the phase III on MDMA. So we're in that process now, which we think is necessary, just to generally expand the business, with the U.S. pharma market being the largest in the world. You've got the executive order accelerating. Trump can't wave a magic wand and make psychedelics legal. I'm sure the Supreme Court would overrule that pretty quickly. DEA would probably have something to say. You need all the corresponding FDA processes to actually happen so that there's codes applied, physicians can submit, insurance reimburses, everything else happens as a result.
Again, Compass to date, all the things I've just mentioned, catalysts ahead are really the continued Australian expansion, the phase II trial as I mentioned, the phase III trial. Of course, Ibogaine, it'll just primarily be for research purposes. Compass is likely, it looks like, to potentially get through phase III and be commercial at some point next year. It'd be great. Because, again, we're not subject to their patent protection, et cetera. We have a different product, right, for all intents and purposes. So it's an interesting scenario when at the point we're eventually commercial because the price differential will be significant and the efficacy will be the same, and some folks even argue better with natural psilocybin across the medical community even. The management team has mentioned, Chip's been great, just generally supportive. He's pretty busy trying to take Lululemon back, as you may know.
He's in a proxy battle trying to get a couple of board members in. Also Amer Sports, which you may know that stock. It's a $20 billion or $30 billion market cap apparel company that he owns a big slug of. Harley's advisor is kind of a wellness guru. JJ, our chair, these guys are all entrepreneurs, right? This is three families that built three different businesses in Vancouver ranging in size from billions to hundreds of millions to tens of millions. So you have an awesome management team that really is, sure, it's a wealth creation vehicle for shareholders, and people want to hear that from us, and I suppose for the current shareholders. This is a company that is focused on access, right? It's providing psychedelic medicine to folks globally with these initial markets underway.
We just brought on Michael to run the trials. He was at U of C Calgary and made a ton of sense to bring on. Then myself, I just joined the company in July just to kind of run the gamut on U.S. regulatory primarily. Then we may start hiring as well in the U.S. If we were to hire, for instance, a U.S. CFO, we'd probably locate him right there in Ohio with me and other folks that may be regulatory specific. So yeah, I think that's it. CAD 9.2 million post the deal. Again, we raised the minimum. We have the ELOC out there. That 17% is underrepresented. That's just the direct find of the individuals. As mentioned, it's over 50% if you collect all the family offices and folks affiliated with the individuals. We've done all this with CAD 30 million. That's the crazy part.
I mean, Atai raised CAD 1.5 billion, sold for CAD 2.8 billion. So super capital efficient. That just shows you how scrappy we've been as an entrepreneurial company and gotten to this point. So why Optimi? Commercial today, path to registration, natural differentiation, a bit of a moat, some policy tailwinds, and some optionality around where that goes. With that, I will take questions. If there are any. It is four something, so.
Oh, Psychedelic Alpha. Yeah, it's a great website.
Yeah, great website. Highly recommend. There is a bunch of NIH studies as well if you are interested. There is a ton out of multiple universities. Yale has got a huge psych group. The whole UC system has a huge psych group. Yeah, there is kind of validation up and down the aisle, which is great.
Yeah, let's go. I did not bring any product for anyone to sample. Sorry. It is not legal here in the U.S. You should go through a therapist anyway and sit through a four to six-hour session. Not our product because we are not actually allowed to. But of course, that is what led the whole team down this sort of psychedelic path because Dane had significant experience. JJ had a significant experience. Because we have all been on, we are, for better or for worse, wellness-oriented individuals. As you know, my prior company was in the wellness space. Prior to that was capital markets, where I invested in a lot of wellness-related companies.
You have to be oriented from a mindset perspective, and you may or may not have an indication. There's a lot of medical tourism that does happen. A lot of those state programs just have people who want to try and see what effectively happens. That's not a super great use case. Again, you usually need to have a specific indication that you're trying to solve for. But we've seen the effects on people who have significant indications within our network, and they have come out the other side just in far better shape, great resolve. In fact, my wife is why I'm so focused on it because she was literally on, she's a high-performing entrepreneur, had a bunch of anxiety as a result, and her psychiatrist can't technically recommend psychedelics. But in California, there's a lot of different ways. There's a religious exemption, all these other things.
It turned out that she's like, "Well, I don't want to be putting on any of this stuff, SSRIs, et cetera, or even Xanax. I don't even want to have to take a Gabapentin. How do I avoid that?" Psychedelics allowed her to be able to do that, where you basically are off everything. She did a few, but yeah.
For example. Yeah.
Well, they can go once, and they could have a significant neurological impact. The regimen is, your psychiatrist or psychologist or therapist will run you through talk therapy. They probably have prescribed three or four things prior to that to try to get you to a better place. Then they'll decide to run a session, so they'll have a space defined that's usually calming in some way, in a room in their facility. You'll be scheduled for four to six hours, and the state facilities run in a very similar manner. You'll then show up for your session. You'll sort of ground, set some intentions as to what you're attempting, the memory and/or trauma you may have experienced.
Again, that might not even be something you're able to talk about at that moment, so you're just sort of centering it in your mind, even from that perspective. Then you'll end up taking the dose of prescribed psychedelic. It'll onset about 30 minutes. It'll peak at about two hours, and then it'll kind of dissipate over the following two hours. So there's a four to five-hour total span. What the therapist will guide you through is if you've had a significant. So MDMA's an initiating psychedelic because it basically gets you past all the fear and the inhibition in your mind. As a result, that's why it works for PTSD. Because someone who's been in warfare and had a significant traumatic event doesn't want to remember that event and is fearful every time they think about it.
MDMA effectively allows them to bypass, from a neurological perspective, that fear and be able to then talk through that significant traumatic event and then come out on the other side having a better grasp of why that had an impact on their life. Folks have said they've gone through that and come back on the other side and never need another dose of anything because that singular session got them to the point they needed. Yep. Then the second is sometimes follow-up. We've only seen as far as a third necessary. Sometimes people come back like a year later just because they want to reintegrate or think through an ancillary component of the trauma. That's pretty common. There's tons of people, though, that just do it for wellness. There's lots of people in Silicon Valley that have been microdosing LSD and psilocybin for years.
Steve Jobs used to say that LSD was how he got to multiple creative inflection points.
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It depends on the dosage. If you're in the one to 5 mg range with psilocybin specifically, it actually creates greater focus. What's interesting is it's not a euphoric sensation. It's literally, yes, if you go over 5 mg, you'll end up in a scenario where you'll visualize. Things become more vibrant. Colors are more acute. You will have not necessarily hallucination, but you'll start to see visions of various things. If you stay in the dosage level that's medically prescribed, what it's doing is sending more blood to the areas of your brain that don't get blood regularly, your default mode network has less blood, right? The framework that your brain is trying to constantly operate around is dampened substantially.
Areas of your brain that are, this is just sort of a layman's version of, are basically starting to fire and correspondingly letting you access memories and/or thoughts that you otherwise wouldn't want to think about. I joke that with AI and everything that's taking over the world and the anxiety that's being created, mushrooms might save the world. Literally, how else are we going to refoster creativity and folks damping their anxiety? I have a T-shirt I can wear next time. Totally. Any other questions? All right, great. Thank you so much.