Welcome, everyone, and thank you for joining the H.C. Wainwright 28th Annual Global Investment Conference. My name is Joshua Korsen, and I am a Senior Equity Research Associate. With me today, I would like to introduce our presenters, Dane Stevens, Chief Executive Officer, and Robert Martin, Chief Strategy Officer of Optimi Health. The floor is yours.
Thanks so much, Joshua. Optimi Health is a direct-to-clinic psychedelic drug manufacturer, ticker symbol OPTH. We would like to thank H.C. Wainwright for having us present at this conference. I will introduce Dane Stevens here in a moment as we roll through the deck. Standard disclaimers up front. In terms of investment highlights, we are commercial today, so not many psychedelic companies, if any, we believe, can claim that. I think we are the only NASDAQ-listed company with product in-market, shipping currently to Australia via their Authorised Prescriber Scheme, and also providing both psilocybin and MDMA via Canada's Special Access Program. We are vertically integrated with a facility in Princeton, British Columbia, which manufactures and encapsulates and ships our product to Australia and throughout Canada, as well as to testing sites throughout the world. Our main differentiation is we are a naturally extracted psilocybin.
As many of the folks on the call may know, drug developers spend time on synthetic formulations. There is a large market globally for natural psilocybin specifically, that is effectively a gray market at this point, which we have obviously no interest in being part of. However, we would like to see an authenticated version in market as it has become the case here in Australia, and then additionally, potentially in Canada, and then of course, the U.S. is moving reasonably quickly, more recently on the psychedelic front with psilocybin front and center, along with ibogaine, MDMA, and others. We are serving a very large market, as folks are probably aware, via PTSD or treatment-resistant depression.
We have got a lot of global optionality, given our early success in Australia, with a number of countries we will go through in a moment, to potentially also commercialize and bring drugs to market around the world. Our early mover advantage is really having two drugs currently in market in their effective generic or off-label format, with ibogaine being the third in development given the recent Trump initiative. With that, I will turn it over to Dane. He recently returned from Australia, visiting with a number of clinics that we service there, just to talk about the patient experience, the two products we currently ship to Australia. Or actually three, including the microdose, which are psilocybin, MDMA, and then as mentioned, ibogaine is in development, which we were already working on, given our Health Canada license to do so across any psychedelic.
And have had inquiries, it seems daily since the Trump announcement from around the world. We do expect to potentially have an ibogaine completed product by year-end. We are currently sourcing the APIs, as we had been prior to the Trump announcement, and we have just accelerated that program. With that, I will turn it over to Dane to talk about the founding of the company. Dane is a co-founder, along with three other folks. The Wilson family probably being the most notable. JJ Wilson from Lululemon is the chairman of the company. The company, as mentioned, is located primarily in Princeton, however, also in Vancouver. We just recently up-listed here in May of 2026.
Awesome. Thanks, Rob. A little bit of history. Optimi is a company that I founded six years ago. We are based out of Vancouver, British Columbia, Canada, and our production facilities are three hours east of Vancouver. We are not a classic, I always say this, we are not a classic drug development story. We are a commercial stage pharmaceutical company. What we focus on is actually making the products, as Rob mentioned, naturally derived psilocybin in a 5 milligram capsule, which today is being prescribed in Australia for treatment-resistant depression. We have a 40 milligram and 60 milligram MDMA capsules that we make on-site as well, under our Health Canada issued license to treat PTSD in Australia. As well, both of these drugs are used to supply clinical trials to various groups that are studying these programs.
One of the reasons we got into this today, I think it is always important, is that we saw very early on, we come from Canada, where we have had legal cannabis since 2017. We have had special access programs to access these products for many years. We looked at it and thought, nine out of 10 statistically, drugs do not make it through the clinical trial programs or drug development programs and make it to treat a patient outside of that. For us, we focused on the manufacturing and believed that from the very beginning, even though people thought we were a little bit crazy, was to actually focus on the manufacturing of the products. It turned out that thesis was correct as Australia rescheduled, and now we are seeing Canada have Bill C-286 come to light and hopefully some rescheduling there as well.
We are very excited about the direct-to-clinic model that we have built. We are in 26 clinics today, I should say, in Australia. We are hoping to be in about 100 by the end of 2027, and we are very proud of that. We are one of the only companies, as Rob mentioned, that is actively treating patients outside of a clinical trial that is listed on the NASDAQ. The next question I normally get is how did we finance this? Predominantly through my family's company, our family office, and then Chip Wilson, who is, as Rob mentioned, very notable for Lululemon and Amer Sports. He has been one of our longest-standing advisors and shareholders, and his son, JJ Wilson, is our chairman.
It has been six years of putting this together and finally getting to this point of true commercialization, which we are excited to understand a little bit more, as everybody is, what the U.S. market looks like with psilocybin and MDMA, knowing that both of those drugs are being submitted to have registration and access for Americans. We are obviously focused on just Canada and Australia today, and we are excited to look past that. I think one of the things that also we get asked is how many states have psychedelic legislation, which is around 26. We are keenly looking at the markets as they grow and treating significant unmet needs.
We are also focused on federal approval, of course, of those state programs. We are not currently providing to those state programs, nor would we without federal approval, just to clarify.
Correct. Yes.
Additional.
Yeah. We did go through. We have an FDA site license number from the FDA. Upon a commercial market for the drugs that we make, we would be able to enter that market shortly thereafter. Just to clarify, Robert Martin, you are right. Thank you.
In terms of the drugs we offer, I think folks on this call are probably pretty familiar with psilocybin in its natural or botanical format, is how the FDA classifies it. We could talk through what rescheduling looks like for a botanical versus synthetic. There is something called bifurcated rescheduling, which would mean they would potentially reschedule a synthetic first, which may be the case with the Compass drug that is in phase III trials now, and then subsequently, potentially reschedule the broader generic or natural substance, which is what we provide. Then MDMA, as folks probably know, is a 100-year-old recipe, 100-plus-year-old recipe, that you can certainly make in an alternate synthetic format, but is not really necessary. I think there is a number of initiatives, including the most recent resubmission by Resilient, formerly Lykos, on MDMA specifically, which Dane can talk to you.
But MDMA is also, within the psychedelic realm, considered quite effective for a number of issues. Then, of course, back to the GMP manufacturing. We are cultivating and sourcing the APIs, as mentioned with ibogaine. We grow the mushrooms on site for psilocybin, and then we go through the extraction API process. We formulate. Our Chief Science Officer is a chemist by training. We, of course, go through quality control and then release, and then, of course, export and dispensing via a Drug Establishment Licence with Canada, which people may be familiar with, and as well as an excellent relationship with Health Canada and approvals accordingly for pretty much every psychedelic. Initially, Ibogaine is not a scheduled substance, so we also have ability to manufacture that as well, in addition to pretty much every other psychedelic.
Yeah
LSD, et cetera, DMT on down.
I would just say also, I think the easiest way to explain this is that we have a vaccine-level facility that is licensed to make these drugs and the products that we make, specifically MDMA right now and psilocybin as finished drug products. Those are able to be prescribed for whatever indication the country allows. So, for example, in Australia, it is specifically psilocybin for TRD and MDMA for PTSD. But in a situation like the Czech Republic, which has recently rescheduled psilocybin, or potentially in Canada, the same product that we are selling into the Australian market and studying at a clinical trial in the U.K. can be prescribed for whatever the doctor and the patient want to do with that. So it can be indication agnostic between all of the ones that I think everybody on this call is going to be familiar with, PTSD, MDD, TRD.
I think that's a key differentiator for this company, is that we went regulatory first. We have Health Canada on site watch us manufacture these products to a high level where it's a commercially available product today, which is again, I think our key differentiator at this company.
Australia has really been a case study. Not to say the U.S. will necessarily follow their lead, nor would Canada. Canada is more likely, frankly, to. We're seeing, of course, with Mark and the One Canada initiative to foster innovation and new industries. Healthcare, other than as a service provider, is not a significant industry in Canada, but the psychedelic industry broadly certainly could be. Canada is actually moving a bit faster with a recent June proposal than the U.S., and it has the ability, just from a political, infrastructure perspective, to possibly move faster than the U.S., which we'll talk about here in a moment. With respect to case studies, ketamine is an interesting example of a both off-label generic as well as a developed drug via J&J's SPRAVATO.
That market has grown quite phenomenally in just a few years' time, and it feels like the FDA is trying to get in front of that scenario as well as the peptide and GLP scenario, where they're trying to understand the generic version or generic versions of psychedelics and possibly regulate those through a broader rescheduling. We're seeing a variety of initiatives that we'll talk through in a moment on the regulatory front. In the meantime, maybe Dane can just talk through a little more on Australia and what that's looked like over the last year or so.
Yeah. We shipped in our first MDMA capsules about almost two years ago now, and our psilocybin capsules, not quite a year ago, but very soon. By the time this maybe goes out, it'll be a year since we've been in market with both drugs. It's a very linear process with the drugs that we manufacture at our facility. We're allowed to actually finish the packaging and do everything on-site and release the products directly to the pharmacy partner in Australia. What happens then is the patient and the psychiatrist would order the medicine from a pharmacy, and the product that we make and have shipped into Australia would end its way at the clinic, where the Authorised Prescriber would hand it over to the patient, and they would do their journey.
Further to that, very recently, we have insurance reimbursement from Medibank, which is Australia's largest private healthcare insurer. Along with if you are a veteran, you get government reimbursement for the treatment that you are doing, plus the product. It is a very interesting case study, as Robert Martin mentioned. It is a fully functioning market where these drugs have been rescheduled for many years now. There has been zero serious adverse effects to date, which we are very proud of, using our product or any of the products that are in the market. It is a fantastic example, and one that I know that Canada is going to be looking at to duplicate as they put that through the House of Commons.
In terms of global rescheduling, I think folks are likely aware of the Trump initiative in April, then he just reaffirmed it a few days ago here in August. Between frankly, today and the time of the conference, who knows what could potentially happen, given how fast things seem to be moving. In the U.S., there is a September 14th FDA hearings that we will be in attendance, and perhaps be called, and we will find that out by the time we are at the conference, to testify given our experience in Australia and generally. At this point, as folks know, in the U.S. specifically, Schedule I for both psilocybin, MDMA, and pretty much every other psychedelic. The potential for it to go to Schedule II, more likely Schedule III, Schedule II is less likely.
Schedule III is better for the industry broadly, is accepted medical use covered by insurers. Everything that is effectively happening in Australia for us now. Of course, Trump is a huge advocate. He has got RFK. We have got a recent new appointee to the FDA, that also seems favorable with respect to the industry and wanting it to be available to patients in a reasonable timeframe moving forward. It has really been an inflection year. I think what we have seen since the executive order. Czech Republic is another country we will talk about here in a moment, which is obviously central to Europe broadly, along with Switzerland as a potential point of access. We have got the FDA seeking guidance, as mentioned, on the September 14 hearings, then we have got additional states, as Dane Stevens mentioned, continuing to come online. Compass Pathways going through phase III.
By year-end, early next year, we will have a further indication of where they land, which seems very likely that they will have a psychedelic drug in market sometime in the next 12 - 18 months. Of course, ATAI Life Sciences was recently acquired by Eli Lilly and Company, which also has drugs in development that will be in market, I think it is in 2029 or 2030. There is certainly a number of companies working on various drugs that could potentially come to market over the coming years. This is the global regulated access framework. Australia, as mentioned, Canada, Switzerland, the U.K., U.S., Germany, Czech Republic, and New Zealand. We have got a fairly large global audience as potential customers. Just with Australia and Canada, we believe we could generate pretty significant revenue depending on how those programs continue to roll out.
Australia has been a bit gated as they have no marketing for drugs over there, and it is really one by one in terms of the therapists coming online. That has been effectively doubling quarter-over-quarter. As Dane mentioned, we are seeing clinics come online at a similar pace. So that market alone could be of significance to us. We seem to be the primary provider at this point in Australia. Canada as well, a bit larger size, could also come online, as mentioned, if Bill C-286 and another bill start to fast track a bit over the course of the next year. In terms of other-
I was just going to add, too. Sorry, Rob, you are on a roll. It has been six years of starting this, and I think it is just adding context to how fast things have gone in the last year. Even the last six months has been incredible to see. You get the leader of the U.S. and then one of the most polarizing and popular people on the planet talking about this has been really huge for us. We are obviously keenly looking at what comes next. Thanks.
You know the comps likely if you are in this space and you are listening to this broadcast. Compass Pathways, AtaiBeckley , Helus Pharma is also in Definium Therapeutics, all different psychedelics depending on the company. Again, these are all synthetics, so there is not another company that is currently in market and/or focused on natural psilocybin, specifically botanical psilocybin or a generic version of MDMA. So we have this various scenario slide, which is anyone's guess, given the regulatory framework here in the U.S. specifically. As mentioned, it does appear that Canada on bullet 4 may move a bit more quickly. Obviously we are a Canadian company, we spent a lot of time in the last few months with both that legislator as well as other folks that have an interest. It really does feel bipartisan there as well, which is great.
As mentioned, Mark has a One Canada initiative, so it could fall under that purview as well. We have got the FDA currently in evaluation with the September 14th discovery hearings, as mentioned. Of course, we have got the executive order continuing to push on the ibogaine initiative. We seem to have, as I may have mentioned, an inquiry a day on ibogaine around that initiative and just globally. In terms of catalysts upcoming, continued Australia expansion, which is why Dane was just spending a week over there and understanding our broader market. An ibogaine finished dose perhaps by year-end. Compass potentially moving forward on the synthetic front with respect to psilocybin, and the executive order implementation with respect to ibogaine specifically. Then you have got continued states coming online. New Mexico is the next likely to come online here by year-end.
Then, of course, the Canadian bill as mentioned.
Mm-hmm. I'll just add like, you know, we make these
Sure
Yeah, sorry, Robert. We make these products, and we're seeing now finally the commercial market opening up, whereas predominantly before, it was clinical trial supply. I think that's something that we're very excited to see, and then, as Robert mentioned, all these different markets coming online. Thanks.
The management team, as Dane mentioned, is led by Dane as CEO and Co-Founder, along with fellow Co-Founders JJ Wilson, Jacob, and Bryan. Bryan and Jacob, just for reference, run one of the largest cannabis companies, private cannabis companies, in British Columbia called BC Green. So they certainly understand distribution. They distribute their product globally, and the facility is built adjacent to their cannabis facilities in Princeton, British Columbia. Of course, we've got Chip as a supporter as well as Harley. Preston, as mentioned, is a chemist by training, and then myself on the management team. Apologies for whipping through this a bit quickly, but we were told we had 20 minutes, so we'll just go through the financial highlights briefly. We've got recent offering that happened in May for $15 million U.S.
We have 9.2 of that after all the fees and everything else associated, plus some debt we paid back. Then we have raised 30 in total, as Dane mentioned, most of which has come from the founders and investors like myself. I was originally involved in a couple of private placements that the company had done, all CSE listed. While it says 17%, if you include friends and family or broader, it is closer to 50%. Again, we are definitely eating our own cooking and spending a lot of time thinking about how to get our drugs into patients' hands globally. Now I will turn it back to Dane to close, and just give you some highlights of the
Sure
last slide here.
Yeah. The biggest one is we are actually commercial today. However this rolls out in terms of, we look at competitors or other companies that are developing specific products, the rescheduled environment levels the playing field for companies like ours to come in and actually be a direct competitor to anyone that wants to treat a patient, similar to how you have both on-label and off-label ketamine use throughout the country over 6,000 clinics. We focused a lot on actually making the products, as we mentioned before, how we went through that regulatory process. We knew from day one that someone actually has to make these psilocybin capsules and the MDMA capsules and now the ibogaine capsules for patients to use.
We look at the tailwinds, we look at how much we put into this business and understood it was going to be a journey, and we are finally feeling we are at the tipping point or inflection point, whatever you want to call it, and it is a very exciting time. I think that the team has done a great job of showing that there is a space for the manufacturer to come in and compete directly with drug developers. I appreciate everybody's time.
Yeah. Thank you so much.
Yeah. Okay, great.
Yeah, great. I want to thank our presenters for their informative presentation. Please feel free to reach out to management if you have any questions that come up.