Hello. Welcome back, everyone. I'm joined by Payton Nyquvest, the CEO of Numinus Wellness. So this is one of the leaders on the delivery side for both novel and traditional psychiatric services. They've been heavily involved in the psychedelics medicine space, and have relationships with many of the leaders across that industry. So before we get into our conversation, Payton, why don't you give us a brief two to three-minute overview of what it is that Numinus is all about?
Yeah. So Numinus was founded about seven years ago, and, you know, to your opening comments, really kind of focus on the delivery side of, you know, traditional mental health therapies, and then, you know, as more and more kind of novel interventions come online, like ketamine-assisted therapy, as well as, you know, we've been very involved as a clinical trial site management organization. We've been the number one enrollment site for pretty much all the major psychedelic studies to date. You know, how do we incorporate those interventions into, you know, the mental health space? And, that's really been our focus. You know, ketamine-assisted therapy obviously is, you know, the first sort of approved psychedelic therapy that we've had access to, and we've sort of been at the forefront of that for quite some time now.
Not just on the sort of delivery side from the client perspective, but also, you know, spending a lot of time building out the reimbursement infrastructure, the operating SOPs, you know, really what it takes to integrate these practices into, you know, a multidisciplinary mental health offering, which is, you know, primarily what the infrastructure is there and supporting at the moment. And, yeah, you know, looking towards the future, obviously, you know, it's been an interesting year with what's happened with Lykos and kind of the FDA process that they've been in. But, you know, the second half of this year, frankly, you know, we're very excited.
You've seen a number of Phase II and now, you know, Phase III studies start to kick off, and, I think, you know, while the Lykos ruling from the FDA may feel like a little bit of a setback, I also think it's been a huge learning opportunity for the drug developers, and I think it's also really brought back to the focus of, you know, what does implementation look like? What does this model really look like in a clinic?
Mm-hmm
A nd we're really excited about, you know, what the next year looks like.
Yeah. So given your unique perspective as someone who's involved with pretty much everyone in the space, I would like to dedicate a little bit of time to talk about, you know, what happened with that, Lykos FDA decision. What were the main hang-ups from the FDA, and how generalizable are they to others in the space at large?
You know, I think you have to kind of look at the protocol and how Lykos is, you know, sort of looking at their treatment, right? You've seen ketamine models where, you know, the focus and approval of that was really kind of drug focused, and it sort of left it up to the market to figure out what, you know, delivery of that was gonna look like. Certainly, you have your REMS and things like that, but you know, you've seen a kind of broad diversity in regards to what that offering is, everything from, you know, sort of ketamine-only dosing to, you know, high touch, lots of therapy, lots of support.
You know, I think if, if we draw from a lot of the learnings there over the last couple of years, you know, you, you've seen the market kind of swing from really drug-dependent or drug-focused to understanding that, you know, it really does matter that the sort of therapeutic container that these, these sort of offerings are, are being included in. And so, you know, I think if you go back six, seven months ago, breakthrough therapy status, the results were quite compelling. It was sort of this feeling of a foregone conclusion of this was going to be approved.
You know, in my own opinion, if you sort of look at the history of MAPS and Lykos, you know, it's been in this container of nonprofit, a lot of advocacy work, and, you know, they made the decision to split those two companies out a year ago. I probably would have preferred to see that happen sooner, because, you know, while a lot of that advocacy work has been crucial to the space, it's not something the FDA really overly pays attention to. And so, you know, they're in this process now with the FDA of understanding, you know, what they're gonna wanna see in regards to, you know, how they might approach another Phase III, or what additional data is needing to be captured. But, you know, this is.
I think what's important to remember is the FDA doesn't really regulate therapy, right? The FDA regulates the drug. And I think there was a lot of emphasis on the therapy, which is just sort of outside of their wheelhouse. And so that's where I think a little bit of that fell short with the FDA. And so I think, you know, if you review the panel, there was a lot of questions that came up in that panel, which as a person who understands it, you kind of scratch your head and, you know, wonder why a lot of those questions are relevant. But it's their process, right? So I think, you know, Lykos now has... You know, they've got some very strong funding partners. My assumption is they're probably gonna.
Understand really, really acutely what the FDA is going to want to see, and come back with a very thorough plan to move to approval after probably gathering a little bit more data.
Yeah. So one of the things that we did see on the AdCom in particular was a lot of discussion about the importance of therapist training.
Mm-hmm
H aving a safe and reputable provider to provide a safe environment, given that, you know, these patients are under the influence of a psychoactive drug, and then also consistency across delivery.
Yeah.
So could you talk a little bit about what Numinus does to ensure all of those things, in particular on the training side, because you do have your own training program?
Mm-hmm. Mm-hmm. Yeah, like, you know, I can't emphasize enough the importance of training and, you know, and really the sort of infrastructure that's there that's needed to be able to really support these people in the way that they need. And I think, you know, when we think about mental health drugs, you know, this is a very big shift from the way that we've treated these different indications in the past, right? Where it's been, you know, whether it's an SSRI or an antidepressant, it's something that you're taking on a daily basis. It's not got that kind of therapeutic support. And, you know, the framing that I think we need to think about these interventions is it's an intervention, right? It's.
I akin it to, you know, if you're going in for a knee surgery, for an example, right? You don't want somebody who's, you know, just had a new scalpel approved or something that they've never worked with before, and they say, "Okay, great, I'm gonna throw that into the toolbox," and similarly for the patient, you know, this is an intervention, and if you go back to the knee surgery analogy, you know, you can approach that with really good prehab and taking care of yourself, go into that intervention, then do really good rehabilitation after, and the chances of that intervention being successful are high.
Mm-hmm.
If you go in, don't take care of yourself, you know, go downhill skiing all the way up until the intervention, get the intervention and start downhill skiing and not taking care of yourself after as well, the chances of that intervention being successful are fairly low, and I think that's education on both the provider side and the client side as well. You know, over the last number of years, you've seen a huge amount of interest in the space, but I think coming back to the real importance, and it was one of the things we were really happy to see with the AdCom and the comments from the FDA, is that, you know, qualified sites with qualified practitioners who have a certain.
Yeah
A mount of training are crucial. And so we've focused quite a bit over the last number of years around what does good training look like and what does good support look like? And we've had an advantageous, you know, kind of point of view on that, not just from the work we've done on the clinical side with ketamine and the amount of experience that we've gathered, but also because we've been involved with so many different clinical trials and a lot of those clinical trials being carried out with our own practitioners and with our own clients in our clinics, is we have seen in sort of a real-world context of what it actually takes to take somebody into one of those protocols and then support them after the fact.
Yeah. So I would also like to touch a little bit on functional unblinding, right? This is something that did come up.
Okay
D uring the AdCom, and as you mentioned, for some of us in the space, this was a bit confusing why this came up, because it is a known issue. But you are involved with COMPASS, you're involved with MindMed, you're involved in many of the major trials in the space. Can you talk a little bit about how you design around functional unblinding? And then, you know, given that this is not exclusive to psychedelics, pretty much anything that is a psychiatric drug does have a certain degree of functional unblinding. So given the extra focus that is placed on accounting for this, could it be said that the psychedelic medicine trials are actually among the more robust trials that have ever been done in psychiatry?
Absolutely. And, you know, I think, not to digress on this too much, but, you know, if you look at what happened in the '70s, I mean, thousands of clinical trials with psychedelics were carried out.
Mm.
And so, you know, the understanding around, you know, the blinding issues and things like that is something that the industry has been well aware of for a long time. And I think going back to the AdCom, you know, I think that was maybe one of the missteps that happened with Lykos is really educating the AdCom on, you know-
Mm
The process they went through around the blinding issue. Which, you know, again, I think a lot of people, you know, look at the feedback that happened there and kind of say, like: "You know, well, where was the planning around a lot of this?" But Lykos did spend a considerable amount of time with the FDA trying to address this blinding issue. And, you know, a clinical trial protocol doesn't just magically happen, you have to get approval.
Yeah
F rom the FDA in order to do that. And so, you know, they had gotten the go-ahead from the FDA around the blinding issue. But to your point, it is a huge challenge with all psychedelic therapies and clinical trial work that's being done at the moment. It's pretty clear and obvious really early whether you've got a placebo or whether you got 150 mics of LSD. You'll know fairly quickly, and for a fairly long period of time, where somebody's gonna be at. So it is a challenge with the clinical trial work that's being done, but to your point, you know, the robustness of these trials and the way that the drug developers are approaching them is very significant.
I think, you know, one of the pieces of feedback around Lykos was just the size or the sample size that they took from around the Phase III, and I think, you know, that also points to the fact of, you know, these trials are hard to do. They're not easy, and enrollment is a challenge. That's, you know, where we've been fortunate and very successful is we have been one of those number one enrollment sites. That does come down to just making sure that you've got, you know, the right people, and you know, the right infrastructure in place to be able to execute on these trials.
All right, and so, you know, you do stand to benefit pretty significantly on the approval of really any psychedelic medicine.
Mm-hmm.
But now that, you know, COMPASS looks like it's the nearest. We're waiting probably somewhere in the range of a year, give or take a couple months, for their second Phase III readout.
Mm.
So in the interim, in that near term, could you talk a little bit about your plans to help move Numinus towards profitability and grow your revenue base?
Yeah, to your point, I think COMPASS and Usona, in my mind, are probably the two closest at the moment, and you know, I think both groups have been very thoughtful around their study design, and you know, I think they've taken a lot of learning, obviously, from what's happened with Lykos here over the last little bit. But you know, yeah, to your point, we've always built the company not to be beholden to any one particular approval. We do stand to benefit from anybody that gets approved, and I think going back, you know, to what we were mentioning in the beginning, is that these modalities are always gonna be done in the broader context of a diversified behavioral health offering.
You're not gonna see kinda standalone off- you know, organizations that are just doing one particular psychedelic treatment.
Yeah.
And so that's always what we built it on, and so, you know, ketamine therapy for us continues to be very successful. I'm sure you probably saw the most recent Janssen numbers, but continue to be extremely successful. And I think, you know, the awareness around these different modalities continues to broaden. And we continue to just be rooted in behavioral healthcare. So we've continued to reduce the burn rate as much as possible. The clinics that we have down in the U.S. continue to improve quarter over quarter. Saw a little bit of a setback through a slower season at the early part of last year, but other than that, things continue to trend in the right direction.
And our clinical trial business really continues to thrive, especially as these larger trials are now kicking off, too. So I would say between those two things, we've seen increased profitability and, you know, obviously, the market's been a significant challenge over the last year or couple years. Can't get into it too much, but we've continued to explore avenues around potential M&A opportunities that continue to benefit, you know, the direction that Numinus continues to head in, while helping support, you know, any of the overhead. And, you know, where we see the huge opportunity in growth, not just, you know, this year, but, you know, kinda zooming out and looking at the next couple years, is Numinus probably has more experience in this space in serving clients than anybody else.
And we've looked at the last couple years at, you know, how can we benefit, you know, this space in the greatest way possible? And so we've been building out a kind of a licensing platform where we can license out all of that operational infrastructure that we've built to be able to support clinics who want to be able to integrate these different modalities into their practice, but don't have the resources and infrastructure to be able to build and incorporate that into their practice.
Yeah, and I think, most recently, Janssen was reporting somewhere in the annualized range exceeding $1 billion now.
Mm-hmm.
So it really shows how ketamine has taken off, and a big part of that is having that delivery infrastructure.
Yeah. Yeah, absolutely, and it... You know, I think you look at. It's really been, what, two years now that that drug's been sort of in the marketplace.
Yeah
A nd so it's been incredible to see the growth, and we spend a lot of time with the Janssen folks. And, you know, I think you've continued to, through this process, see best practices really be prioritized, and that's really where, you know, we've continued to position ourselves, not just with ketamine therapy, but then, as you mentioned, you know, looking at these other modalities where, you know, the price point is gonna be higher.
Mm.
And so people, you know, when they're looking to find a place to go and do this work, you know, the importance of a standard of care that can, you know, hopefully give them the relief that they're looking for, especially for, you know, the investment, whether it be insurance-based or not.
Yeah, and now, could you talk a little bit about the benefits to providing a range of services? Because Numinus provides everything from, I mean, pretty low-level wellness all the way up-
Mm-hmm
T o interventional psychiatry. You do some TMS. So if you talk about how is that something that allows you to create not only recurring revenue, but create a pipeline as patients, if they don't respond to something earlier, can move on to more aggressive treatments?
Yeah, absolutely, and I think that will be the model going forward. You know, as an example, you know, we did about, I wanna say about 120,000 appointments last year, and, you know, nobody is coming to a clinic saying, "Hey, I wanna do psychedelic therapy," right? They come to a clinic saying, "I've got anxiety, I've got depression, I've got suicidality, and I need support for that," and you know, to build out that pipeline of really just trying to meet people where they're at, and then properly supporting them, you know, through that journey, and that's everything from medicine management all the way to, you know, ketamine-assisted therapy or other, right?
And so to your point, I think that pipeline is important, but also, you know, you can't just take someone at a moment's notice and say, "Okay, we're gonna slot you in for LSD therapy.
Mm.
There's a process that you need to be able to take people through. I think you know the final thing to really emphasize in this as well is you know from a clinic owner perspective you're... diversified model where you can you know we sort of see this as maybe a clinic is offering one of these modalities MDMA or psilocybin or other. Most of those treatments are about a four- to eight-hour intervention which is you know a very significant kind of business model change for a clinic owner whose you know most of their practice has been built around one-hour treatments you know kind of filling a room with six to eight people a day and now you're shifting to you know using one room potentially for the whole day for a whole client.
That diversified model is really, really important to your point around not just a pipeline, but being able to build a sustainable financial model for clinic owners as well.
Now, you recently did do a bit of consolidation in Canada. Can you talk about your strategy and your refocus on the U.S. market?
Yeah, you know, the Canadian healthcare space is really challenging. You know, even just talking about ketamine in particular, there's still very limited reimbursement for ketamine-assisted therapy in Canada, whereas in the U.S., you know, about 80%-90% of all of our ketamine treatments get covered under insurance. So as we were kind of looking at, you know, where a lot of the costs coming from, a significant amount of our costs were coming from our Canadian operations. And so, we moved those operations to another company where we still have a relationship with them around the infrastructure and training side of things. But the United States just offers a much more favorable environment for things like reimbursement.
Right.
And that will be our focus, you know, for the future.
All right. And then before we move on to talking about next steps, timelines, and catalysts, I'd like to see if you could just discuss a little bit about the difficulty of gaining reimbursement and deploying these therapies, in particular for smaller providers, and how this might feed into the Numinus Network platform.
Yeah. You know, that's where we've had a ton of focus. You know, as I mentioned, ketamine, we're still one of the largest reimbursed providers in the country, and I think a lot of people assume, you know, a drug gets approved, it gets a DIN number, and naturally, you just get reimbursement for it, and that's just not the case. You've really gotta work with your providers. We work with, you know, dozens of different insurance providers to get that reimbursement for clients, and, you know, that's something that we look to really leverage with, you know, this licensing model, which, you know, is on one hand, as I mentioned with ketamine, where it's a bit of a lower price point than some of these other interventions, but still, you know, a significant investment for people.
But reimbursement will be a huge gating factor for these other modalities, right? You've seen, you know, even some of the initial feedback around the Lykos protocol being, you know, quite expensive. And, you know, for an owner-operated clinic, which is what most mental health clinics are, in the United States, they just. They don't have the resources or infrastructure to go out and build what they need to build to be able to ensure that reimbursement.
And so that, for us, is gonna be a huge focus as we look towards the future in this licensing model is, you know, how do we get insurance reimbursement and just good financial services and hygiene incorporated into these clinics who, you know, want this to be a part of their practice, but it's not necessarily the whole focus for them?
All right, thank you. And before we part ways, could you just briefly walk us through what are the next key events that investors should watch?
Mm-hmm
F rom Numinus?
Yeah, as I mentioned, you know, we have focused a lot on some M&A activity that, you know, we're looking forward to being able to talk about in the next couple of months, but also, you know, as we look towards some of the readouts of the next trials, which, you know, we're probably six months to 12 months from starting to see some of that start to take place, that's, for us, is where we see, you know, a lot of excitement, and in the meantime, we continue to do everything we can to continue to build better and better, you know, financial results for the investors and for the clinics, and, you know, that's been very successful for us.
So I think the next couple of rounds of financials will be quite encouraging, and as I mentioned, now with the clinical trial business really getting into a full swing, I think that's gonna make some pretty good adjustments for us as we look at the next kind of six to 12 months.
All right. Well, thank you for joining us, Payton. Lots to look forward to from Numinus, as well as the space at large.
Thank you. Appreciate it.
All right, take care. Have a great day.