This meeting is being recorded. The Numinus Mental Health Company. Numinus is a TSX-listed company with the ticker NUMI. It also trades on the OTCQX under the symbol NUMIF. Welcome, Peyton. It's great to see you again. Good to see you. Thanks, Robert. Okay, lots of news flow coming out of the psychedelic sector and your company in particular, a lot of talking points. Starting with the big picture, there are several positive catalysts that have come into play for the psychedelics and Numinus in recent weeks and months. Let's start with MAPS, MDMA-assisted therapy candidate for PTSD, which has completed its long clinical trial process with two very successful phase III studies. The consensus view is that it is now a nailed uncertainty that MDMA will become the first Schedule I psychedelic to become federally legalized in the U.S. Can you share with us any insight that you may have, perhaps based on the discussions you've had with MAPS, which is a major collaborating partner of Numinus, about the timeframe we can expect the FDA to green light the therapy? Can you follow that up with your thoughts on how quickly you think Health Canada could follow up? Yeah, I think, you know, MAPS has put out a very successful first phase I or first phase III clinical trial. Their second one is expected to be reported on soon. They have already put out guidance that it's not only in line with the first phase III results but improves them. I, and I think with that, you know, something that doesn't maybe get considered as much as well is that the FDA has granted Breakthrough Therapy status to MDMA-assisted therapy, which, you know, is essentially a program that's created by the FDA to help fast track through the clinical trial process and get into market. Don't quote me exactly on this, but I think it's over 95% of drugs that have been granted Breakthrough Therapy status get approved by the FDA. You know, I think what's kind of reconfirmed that is, and I know we're going to talk about this, too, but is the American Medical Association's intention to approve a long form billing, a billing code for long form psychedelic therapy that was spearheaded by MAPS and Compass. You know, MAPS is now shifting gears from being a kind of research entity into a commercialization entity. You know, the sort of general guidance is somewhere kind of mid to the back half of next year is when we would see approval. I think Health Canada is probably going to be in lockstep with that, and we hope to help support that conversation and transition. As most people know, the clinical trial work that MAPS is doing was not beholden just to the United States. It was done in the U.S., or it was done in Canada, it was done in Australia, Europe, Israel. With that trial work being done quite diversely, I think it helps with kind of this global effort that MAPS is looking at with MDMA being approved, not just in the United States but really a international effort. Assuming that approval is given, and as the scenario is most likely that it will, affordability is the key condition for mainstreaming the use of the therapy. On that topic, we've already mentioned it to you by passing here. A second positive catalyst, and one which has arguably not been given as much attention as it probably deserves, is the recent approval by the American Medical Association of its first insurance billing code for a for the long form psychedelic-assisted theraphy, which you mentioned, and that's going to become effective, according to them, from the start of 2024. Mm-hmm. Can you elaborate to us, for us, the significance of the approval and what it means in practical terms for reimbursement from day one. Yeah it comes into effect? Yeah, you know, I think it's a huge step forward. You know, Numinus is grateful to we get about 80% of our ketamine services get reimbursed under insurance in the United States. We're one of the largest reimbursed ketamine providers in the country. All to say that, you know, the billing codes is a huge step forward, and I think a very strong signal around accessibility. I do think in the early goings, though, it's gonna take some time, and I think that's where Numinus is quite uniquely positioned because we have those relationships with insurance providers, with ketamine, and because we've built this sort of financial infrastructure to include reimbursement and billing and all that kind of needs to go into that. There'll be some complexities around reimbursement for the drug, plus reimbursement for the therapy. It's just, it's gonna be a lot of heavy lifting for a lot of the more owner-operated locations to be able to build that kind of infrastructure. That's, you know, through the Numinus network, one of the things that we're really prioritizing in regards to what we can offer and license to other folks is, you know, that reimbursement. To also give people a sense, you know, one of the challenges that the industry is gonna meet in the early goings as well is, as an example, for our ketamine reimbursement in any given month, you know, our AR department is offside by up to a couple million CAD, and we can carry that because we're a larger organization, and we know that the money's coming from insurance and stuff like that. For a smaller owner-operated location, they just can't carry that kind of overhead over month-end. They've got rent to pay, practitioners to pay, and things like that. I think to just talk about accessibility as well, though, you know, there's the cost of the therapy gets talked about a lot. If you think about PTSD, there was some recent data that was posted that says that on average, a person suffering with PTSD is about almost a $20,000 a year burden on the system. If we think about the cost of MDMA therapy, and it's successful to actually cure PTSD, there's actually huge incentives to financially support this work because of, you know, its potential for alleviating that cost. That's something that's probably gonna come in at a price point below, you know, the annual average cost of someone suffering with PTSD. Got you. Okay, let's move on to how Numinus itself is positioning itself for the, you know, against the backdrop of these developments. Now, you've rolled out several strategic initiatives in recent months in preparation for legalization of MDA, MDMA and other psychedelic-based therapies that are likely to be approved in the next, over the next few years. Now, these initiatives include practitioner training programs and the launch of your clinic licensing and practitioner partner program. What are the goals that you have set for these initiatives? Can you provide us with an update on how these initiatives, since they were launched, are progressing towards those goals? Yeah. There's a couple of things to consider when we talk about MDMA and kind of the scaling up of being able to have that be accessed by the market. You know, one of the challenges that MAPS currently has at the moment is they can't be seen providing training for a drug that hasn't been approved yet as the drug developer. There's a unique opportunity for Numinus to really be able to advertise and offer that training in a aboveboard legal setting. You know, the biggest bottleneck for access is gonna be just trained practitioners. MAPS will not give MDMA, the drug, to anybody who hasn't had the appropriate training and supervision. We see a unique opportunity for Numinus to be able to offer that training. That's a revenue-generating activity for us. It's not a cost center. It's something that's a very strong revenue line for us, and we've built all of that infrastructure for scale. So it's something that we can utilize right now. You know, kind of in lockstep with that is, one, we have to train a lot of people to be able to offer the therapy, but two, we also have to give them a place to practice. You know, as I mentioned, the sort of infrastructure that's required to be able to offer MDMA therapy is quite significant. You know, just based off of our experience with opening integrative mental health centers that are focused on psychedelic therapy, the average cost of building one of those clinics from scratch, and in particular, all the operational infrastructure that's needed, is probably somewhere in the neighborhood of $1.5 million. That can take, you know, up to two years to get that implemented and into market. With our licensing program, we hope to be able to negate all of those costs with a turnkey solution for practitioners who want to get a location open and be able to operate day one, and utilize all of that operational infrastructure, inclusive of training, financial management, and support, clinic SOPs, protocols, all of the reimbursement infrastructure that we've created, marketing. We really give people the opportunity to, as I said, have a turnkey solution and get up and going, as soon as they're ready. Right. That makes, gives you, basically a very strong position in providing these services relative to other clinics and networks. Yeah. Yeah. Okay, on the back of these initiatives, just, continue that conversation. How quickly do you think you'll be able to roll out the MDMA-assisted therapy services across the Numinus network, once approved? What sort of, take-up for those services will you be able to accommodate based on your existing infrastructure? We've set up the organization to be ready to offer, you know, as soon as approval is there. Actually, you know, obviously, through the Special Access Program up in Canada, we're able to actually start making those applications now. We've done so for psilocybin, and there's definitely a window of opportunity with MDMA as well. You know, as I said, we see day one being able to do that. We wanna make sure that we're ensuring quality. I think that's gonna be extremely imperative in the early goings. We've, you know, unfortunately, seen this in the ketamine space, where there was a little bit of a race to the bottom from a quality standpoint, I just, I don't think that that can be sacrificed with MDMA. If you think again, about the size of the opportunity, you know, we have 14 million people in the United States that are diagnosed with post-traumatic stress disorder, and we don't have a good treatment for them. Up in Canada, about 3 million people with diagnosed post-traumatic stress disorder. It's a very, very large market and a very, very large opportunity to make a significant impact. Do you have any sort of ideas of what sort of traffic flow through you could actually absorb in the with the existing infrastructure? Yeah. We haven't given any guidance on that yet. We definitely will over the next little bit. You know, to give people a sense, I think last quarter, we had about 20,000 client appointments just with our current infrastructure. Obviously, that's a blend of talk therapy, ketamine therapy. If you think about, you know, the pipeline of people who are going to be coming to look for this treatment, we have an internal referral source that we can leverage to be able to get people, you know, into the pipeline, ready, prepared, and then as soon as that approval is there, you know, being able to move people into therapy. Got it. Now, beyond the MDMA development we've just been talking about, there is a significant pipeline of I think, I believe there are more than 50 active psychedelic-focused clinical trials targeting a variety of mental health disorders that are currently in progress. Mm-hmm. You've actually recently announced through your Cedar Clinical Research division, which manages three clinical trial sites in the U.S., in Utah and Arizona. Numinus is participating in two of the more advanced programs, as you mentioned, Compass Pathways COMP360 Phase III program, investigating psilocybin-assisted therapy for treatment-resistant depression. There's more recently, MindMed's Phase II-B trial of its MM-120 program, evaluating LSD as a treatment for generalized anxiety disorder. Mm-hmm. Can you explain the importance and the benefits of those research partnerships for the whole- Yeah Numinus ecosystem? Yeah. I think the challenge that MAPS currently has in front of them is the same challenge that any drug developer in the psychedelic space is going to have. All of these drugs are being researched for psychedelic-assisted therapy, and the need for a service infrastructure is going to continue to be extremely important. There's a real... Where we see a really big opportunity is obviously, you know, ketamine was sort of the first opportunity that was there to be able to offer, you know, a psychedelic therapy. I think MDMA will really be, you know, quite a larger catalyst for that. With, you know, being able to use MDMA to really build out that infrastructure, there's then a very natural pathway for other drugs as they get approved, to be able to flow through that infrastructure as well. You know, for us to be able to be the clinical sites for those different trials, it gives us a very close look under the hood as to what is gonna be needed to be able to make sure that, you know, those treatments are able to be integrated and effective day one, once approved. Also, you know, we also get a very close look at when approval is going to happen and when do we need to be prepared for those next treatments as well. In the interim, you know, that business for us around being a clinical trial site management organization is, you know, one that's quite lucrative for us as well, and we've been able to demonstrate really being best in class, in that arena, so. Right. Good. Okay, one final question: It seems like the stars are aligning themselves for the use, the legal use of medical psychedelics, but yet your peers are in the wellness clinic sector are struggling, and even the some of the scaled-up networks have slid into financial distress. I know that diligent financial management has been a key part of your expansion strategy. Can you run through the cost initiatives that you have recently completed and their impact, particularly with respect to cash burn and your timeline for achieving operating profitability? Yeah. You know, we've always wanted to be able to provide scale, but we've known that this is gonna be a marathon, not a sprint. You know, I think a lot of our peers maybe moved a little too quickly without really understanding what's needed to create a sustainable platform. I think, you know, one of the big opportunities that we see is we've been able to demonstrate, you know, especially down in the U.S. on a clinic-by-clinic site, a margin of, you know, 30%-40% on site-by-site basis, which is a very attractive proposition for someone who wants to open a clinic. You know, with that, knowing that, you know, where the timeline was with MDMA and then obviously psilocybin and others, we've really focused on what are the sort of foundational pieces that we need to create today, and then how do we leverage those foundational pieces to provide scale while being, you know, less resource-intensive than rushing out and building a bunch of brick-and-mortar infrastructure. That's, you know, what's led us to this Numinus network platform. In terms of initiatives, we really kind of arrived at an opportune time, where a lot of the money we were spending was going towards building that infrastructure and then building the tools to be able to leverage it for scale. You know, a lot of the reduction that we saw opportunity for was around headcount of people who were building some of those tools that are now finished, whether that's our training platform, whether that's the Numinus network platform, launching of a lot of the new website, digital assets, things like that. Now with all of that complete, we've really focused our attention to not just revenue generation, but profitability and being prepared for when MDMA is there. I will say, you know, with all of the guidance that we've put out, none of that includes revenue from training MDMA therapists or offering MDMA therapy. All of that is incremental upside that we see. We've taken a very conservative and cautious approach to how we think about run rate over the next couple of years. With that, you know, obviously very excited about some of the potential opportunities there and really supporting MAPS in, you know, getting prepared for MDMA being approved this time next year. Great. I think we'll leave it at there today. Thank you, Peyton, for those, you know, informative insights. If there are any other questions for Peyton, please send them to me, and I'll pass them on. That leaves me to wish everybody a great rest of the day. Thanks, Robert. Appreciate it. Thanks, everybody.