Hi everyone, and welcome to day four of the 2021 Credit Suisse Healthcare Conference. I'm Judah Frommer. I cover biotech here at CS, and we're thrilled to have Atai with us. There's been some news in the space that we'll get into. First, let me introduce Florian Brand, CEO, Srinivas Rao, Chief Scientific Officer, and [Chad Mester], who recently joined as Head of IR. Thanks again for your participation, everyone. I figured we could just jump right into Q&A before we get to the news of the week. Maybe we could just first talk about the Atai platform. Maybe a good place to start is just the level of unmet need in neuropsych and mental health and what the impetus was for creating the platform.
Sure. I'm happy to. Thanks for inviting us over to share a little bit on our story and also the founding story that you mentioned, because I think it's important to mention that we came to this through very personal experiences, seeing friends and family members suffer from mental health disorders and not finding any help or healing in the system. That alludes to the significant unmet need that you mentioned. What we realized is not only that the treatment options are so insufficient today, we do not have any really rapid-acting and durable effects when it comes to antidepressants, for instance. Seeing the friends and family members going through this journey made us realize that there needs to be more innovation in this space and that we need to do more. It also made us realize how large that problem is indeed.
It is really a billion people globally suffering from mental health disorders, and that is the diagnosed cases. Mental health is still very much stigmatized, so you could also assume that these numbers in fact are quite higher. We really started out through this motivation to really make a leap forward for patients applying this platform approach to really catalyze innovation in this space.
Okay. That makes sense. There are multiple assets within the platform. How should we think about kind of this balance of, I think some people that are newer to the story think this is just a psychedelic approach to neuropsych, but how do we think about the balance of psychedelic and non-psychedelic assets on the platform? Is there a mission to go after psychedelics, or is that just one aspect of the portfolio and a way to address unmet need?
Yeah, that's a very, very interesting question. I guess it really goes back also here to the founding story. We basically saw firsthand the transformational impact that psychedelic-assisted therapy can have. In the case of Lars, who is also a co-founder, he was diagnosed with a treatment-resistant depression, and ultimately, psilocybin-assisted psychotherapy was what really helped him through this phase in a very, very sustainable way. That was the starting point, and that's why we were initially intrigued in the group of psychedelics, compound group of psychedelics, tryptamines, to really, in a rigorous way, research the potential of these compounds in neuropsych. From there, quickly realized also when Srini came on board that there's so much more interesting innovation potential from oncology, but also digital approaches out there that can equally have a really significant impact once approved for patients.
What's interesting, we're actually very agnostic when it comes to mechanism or small molecules or digital therapeutics. For us, it's really important that the approaches that we are developing are really, truly differentiated, and that when it comes to small molecules, we really see large effect sizes. Ideally, there's also an angle of a potentially disease-modifying angle, something that, of course, in neuropsych hasn't been really achieved over the last decades. I hope that clarifies a little bit, I guess, why we have a portion of psychedelics and why we also have other compounds and also digital therapeutics on our platform.
Yeah, yeah, it certainly does. Another aspect of the strategy that's maybe a little bit differentiated, and we get questions on sometimes, can you talk us through kind of the business development approach and the idea to maybe not always have full ownership in the companies or the assets or compounds that you're working with, and how should we think about business development and kind of pipeline expansion going forward?
Yeah, no, happy to. On the compound selection side, whenever we onboard a new program or onboard a new program in the past, for us, it was important that given the historically rather low likelihood of successes, we are designing an operating model with the intention to really increase that likelihood of success. Basically, we applied kind of a three-layered approach. On an asset level, we were looking and are still looking at compounds with prior evidence in humans. That means that we have a good understanding of the safety profile and at least anecdotally or biomarker signals pointing to the efficacy of the compound in the respective indication. That holds true for psychedelic and non-psychedelic compounds. That is a very important part on the asset level or on the compound level.
We're basically applying a very staggered or milestone-based approach to capital allocation. That is also rooted in how we're developing those compounds. We usually form a company around the IP, the compound, when we incubate a company. When we acquire a company, we basically also don't fully integrate it into Atai, but keep the founders incentivized in an entrepreneurial way. We usually have majority ownerships, but the delta to the 100% ownership is then really the founders that we want still to have skin in the game to keep the institutional knowledge in-house and also to foster a culture of innovation, of risk-taking, and also make them very much focus on their program to execute in their, so laying that on the compound indication that they're set out with.
On the capital allocation side that I mentioned earlier, we're dedicated to really fund those programs and companies and to POC and do that in a very milestone-based approach. Basically, on that way to POC, identify together with them based on the clinical development plan, value inflection points. When they hit, we provide additional funding. When they're not hit, that allows us as Atai also to reallocate funds to areas where we believe we have a higher ROI and a higher likelihood of success. That allows us a real truth-seeking approach versus a success-seeking approach. The portfolio element, that's in the third layer. You mentioned we're not a one-asset bio company. We have a portfolio approach, a platform approach, developing multiple compounds for multiple indications with a truly differentiated pharmacology with respect to the compounds that we're developing.
That approach in itself also contributes to us allowing, yeah, that allows us to take greater risks as it's non-binary, and we can be more also here truth-seeking versus success-seeking, unlike a one-asset bio company.
Yeah, that makes a lot of sense. Another question that we get on this strategy is around IP, which makes sense, right? You're working with naturally occurring compounds in certain instances. How should we think about patent protection for your products, and what are some of the maybe IP wrappers that you guys are using to ensure that there's protection here?
Sure. I'll jump in on this one. Clearly, the concept of developing compounds that do not have composition of matter patents is not new, right? There are many compounds that fall into that class, many naturally occurring compounds, right? Fish oils, for example, LOVAZA and VASCEPA come to mind. There is obviously lots of precedent here. I mean, there are lots of different angles that one could use. Certainly, you have Hatch-Waxman for a new chemical entity, and the provision for the 30-month stay. On the strictly IP front, beyond composition of matter, you have method of treatment claims. You have a lot of composition of matter potentially around some aspects of chemistry, right? Crystals and polymorphs, solid forms and things can provide pretty solid ability to block depending on the ramifications, particularly vis-à-vis manufacturer of those compounds.
There are a lot of things that I usually refer to as label claims. I mean, when you refer to things like the dose, the dosage, the frequency of dosing, the constraints around dosing. That I think is a really rich area for compounds that are psychedelic, right? Because the dosing paradigm is very complicated. It's very different than what is used than popping a pill every morning or maybe twice a day. There are lots of avenues around that, obviously, that require some data. As that gets pulled in, of course, that'll change. Of course, we'll talk about Compass here in a little bit. Another critical element from our perspective is, in fact, the digital therapeutics.
It should be noted that for the naturally occurring compounds, the psychedelic compounds that we're developing, we're building a digital wrap around it, building these things, putting these together and developing those combination products. Combination products, by definition, are it's a drug and a device. The device in this case is either software as a medical device or, in fact, hardware in the context of Psyber. Obviously, it provides a whole another level of protection, right? Just even if no part of that was patent- protected, it's still very hard to take those two things apart. Of course, we have patents filed, and we have a number of patents issued on our digital therapeutics as well. That also provides a pretty important ability to block. Last comment is that we're viewing these as generations, right?
We have naturally occurring first-generation compounds now in the context of entheogenics, for example. We've got completely new chemical entities. We've generated 250, actually closer to 300 compounds at this point. Completely new scaffolds, not seen before, very high potency, very good selectivity. We're also looking at cleaning up and improving on nature's products and coming up with new chemical entities that do, in fact, have composition.
Okay. That's really helpful. Maybe just last one kind of on the general approach here. Can you help us think about kind of the state of infrastructure in the U.S. to support commercialization of psychedelic therapeutics and then also maybe how the regulatory environment is evolving as well?
Yeah. Should I start?
Yeah.
Please do, chime in. I think what's important, and partly Srini already mentioned, our approach, I guess, is part of the IP angle. All the second-generation compounds that we're developing, we really develop with kind of this commercialization angle in mind. The greatest hurdles, if you have psychedelic-assisted therapy, is how do you scale this? How do you get this out to as many patients as possible? To your point, there has been with Spravato already a compound that is dissociative that has to be administered in an inpatient setting. We believe that the most straightforward way here is to really leverage an existing infrastructure and design our compounds to slot in or to fit into that existing paradigm.
Not to reinvent, basically create multiple, yeah, treatment paradigms that you have to kind of each build out on its own, but leverage an existing platform so that we can achieve, yeah, a scale that also benefits patients ultimately as they can access it also in an easier way. That treatment window is that two hours. We are designing the compounds to have a duration of effect of 45 minutes to one hour to really slot into this paradigm. We have seen a good development over the last years, luckily. We have a critical infrastructure now in place. In our perspective, we are still a little bit out from commercialization stage.
That gives us a little bit more time also to be involved to have that infrastructure ready while we, as a company, perceive us really as an R&D-focused company that, yeah, is doing the research and potentially will partner going forward and have the optionality also to be involved on the commercial side. We believe that will not necessarily involve kind of brick-and-mortar clinics. Yeah. Srini, I don't know if you want to kind of chime in on that one.
Yeah. I think one of the important points is the focus on compounds that do, in fact, have a shorter duration. I mean, in the case of our ketamine, it's a little less critical. We're really developing that for at-home use. For the true psychedelic compounds, as Florian pointed out, because of the pharmacokinetics of DMT as well as of [psilocybin] RNA, we can actually use formulation technologies to really kind of limit the duration of psychedelic effect pretty significantly. It's to as little as 20 minutes. In our case, looking really right around the 45 minutes sort of timeframe. Again, to sort of slot into what J&J is already building there. One of the important questions that does come up is around sort of redosing strategies and things. I mean, we don't really understand the relationship between duration of psychedelic effect and durability of response.
It's a very interesting question and something that obviously once we start developing these compounds, we'll get some insights on. The way we're structuring it is through our digital application, we've kind of always assumed that there will be some redosing, right? It's always been the assumption that because of the shorter duration of psychedelic effect, you'll have to redose more frequently. We don't necessarily want this on a fixed schedule. In time, maybe not the next trial, but in time, the plan is to actually have the digital therapeutic help guide decision-making, help guide the physician's decision-making on when patients should be redosed. As you're probably aware, ketamine is on a fixed redose schedule, it's twice a week, four weeks, and once a week for four weeks.
We'd like to be able to walk away from that a little bit, adapt it to the patient.
That makes a lot of sense. Speaking of durability, maybe we could jump into the specific assets here. We'll start obviously with the COMP360 readout earlier this week. I think heading into this readout, you guys had spoken a bunch about assessing rapidity of onset and durability as being two kind of key areas you'd be looking at. Maybe we can start there. Kind of what did you see? Maybe you can work in kind of a dose dependency as well. Important for psychedelics is obviously that they work quickly, but you want to see them last for a while too. What did you see there?
Yeah. I mean, it's always good to see the results replicate in a robust trial, right? I mean, I think that's the most important thing. The trial hit its primary endpoint and hit it quite well, right? That was obviously pretty critical to this compound and this space. The rapidity of efficacy was also very encouraging, right? It really nailed it 24 hours out. Previous demonstrations had not been quite so precise or as rigorous, let's put it that way, right? This was a really robust effect that it was occurring 24 hours out. As we've discussed in the past, one of the important differentiators of psilocybin is the durability of response, right? A single administration lasting for weeks, months.
Once again, we saw that in the context of this compound and this trial, we saw roughly, well, over 2x improvements in remission scores and response scores as they function even out at 12 weeks. Once again, I think all of the primary things were hit. There are learnings here, of course, in terms of dose ranging and stuff, how to think about how to think about when a patient needs to be redosed, etc., things that we will need to dig into these data a little bit more to truly understand that. The fundamental, the investment thesis around psilocybin, I think, was ultimately met with this trial.
Yeah. That makes a lot of sense. Just on the safety side of things, obviously, it's a tough population to kind of delineate safety signals in. What did you see there? What kind of encourages you on that side?
I mean, there was really nothing that was unexpected there, really, right? I know people have made some hay around the suicidal behaviors and ideation and things that seems to be not necessarily dose related. I mean, it seems to be more heavily skewed towards a higher dose. The ends are small, and I think it's worth emphasizing that. We will have to see how this progresses. Per the call with the management team, the statement was made that these are people that didn't respond, right? The ones that took the 25 mg and didn't respond, I guess in that context, it also makes sense. I mean, we can anticipate you shouldn't expect everybody to respond. Of course, those that didn't will continue to have a tough course, right? These are behaviors you'd anticipate in this patient population, right?
As for the dose response, let's see how that plays out over the course of the subsequent trials.
Yeah. Yeah, I think that because some of the feedback we've gotten is like, "Hey, there's an FDA meeting that needs to be held before you kind of progress this asset." Assuming everything goes well there, and that's largely housekeeping, what do you hope to kind of discover further as you move into ideally a phase III? Is it dose? Is it durability? Kind of what are the specific questions you're still hoping to have answered more clearly?
I mean, obviously, we're not privy to those discussions that Compass is having both internally and with the FDA, right? This is all just public guidance, of course. Again, just stepping back and looking at the data, the limited data should be noted as presented, there was nothing that really bothered me from that. Of course, it's really going to be digging into the details. Considering that this is something that has only been tested, I mean, they've been tested in lots of trials, but they're all small trials and they're academic studies, right? They tend to, they may not have been as rigorous as one would like, certainly, and one would anticipate for an industry-sponsored trial. To see this replicate the way it did in a large study in multiple countries, multiple sites in the middle of COVID, I think was very encouraging.
Yeah. That makes sense. We should mention you guys have, I think, it's still a 19% plus stake in Compass officially. The broader read-through here was always going to be to psychedelic drug development, right? What do you see in terms of read-throughs? Maybe not necessarily to specific assets within your platform. Maybe it is to specific assets, but maybe more generally in terms of moving the field forward.
I view these results as incredibly encouraging, right? It certainly validates the underlying hypothesis. Even if you just think about the primary for a minute, right? This is three weeks out from administration. Just ponder that for a second because that's never been demonstrated previously and certainly not this robustly. I mean, ketamine really never went out beyond a week. A couple of studies may have looked at about 14 days, but that was really about it. To hit the primary so robustly at 21 days was pretty remarkable. Fundamentally validating from that perspective speaks to the entire approach of using, well, showing the benefit even on top of therapy, right? I mean, this was much more rigorous in terms of the sort of therapy that was involved. Obviously, it has important implications for us.
We're thinking through our phase II trials in light of these data. Things that encourage me is just the duration of effect and how that's going to, how decisions around redosing are going to be made. Again, we were sort of already there. I mean, this was kind of an important element for us from the very outset. It's like, how do you slot into things, into an existing infrastructure? How do you minimize the overhead required at the doctor's office and for the patient? I mean, in terms of sitters and everything, how can we kind of minimize that? Digital therapeutics have played an important part of that. Of course, short duration likely makes things easier. This is a hypothesis that we have to test. The requirements for a sitter are probably a lot lower.
We want to be able to do this digitally, so to speak. We have Psyber, which is developing hardware for this ultimately, that will provide a digital guide with sort of built-in capability as well as potentially telemedicine, etc. We have a lot of different angles here that I think really do, I mean, they build on this story quite well.
Okay.
Maybe to add to this very briefly, I think it's also important to realize that or to emphasize that some people were very much maybe even overexcited and looking at psychedelics like a panacea, right? We purposefully designed kind of our approach with kind of a very differentiated pharmacology, having in mind that this patient population is super heterogeneous and not everyone will respond to every compound. I think that's important to mention. Yeah, that we have to have a wide array of tools available for patients and that there is most likely not this one compound or this one therapy that everyone will respond to. Hence also our approach and also the importance to look at, yeah, sophisticated biomarker strategies to really tailor and figure out which patient is really the right one for which therapy that we also the industry more broadly is developing.
Yeah. That's a really excellent point. I mean, in terms of psychedelics, we've got at least three, right? Three different pharmacologies. We certainly got DMT that shares a lot of overlap with psilocybin, but we've also got [psilocybin] RNA, which really doesn't. Ibogaine is completely unique unto itself. And then our ketamine glutamatergic, but very different, once again, very different pharmacology. The idea is to pick up different subsets of the population. Now, at the moment, I don't think there's really good data for prospectively figuring out which compound a patient will respond to. That's obviously something that we want to generate over the course of time. In terms of precision medicine, I mean, certainly there's a lot of interest in that. It has been challenging in this space.
We've partnered with a very good group out of Duke that has access to many thousands of individuals. It's Rima Kaddurah-Daouk that is one of the leaders in the metabolomics space and formed with, I mean, she was a founder of Metabolon outside of her academic appointment. So we're partnering with them for a precision psychiatry approach, non-psychedelic, really focusing on particular subsets of the treatment-resistant depression population, wherein mitochondrial energetics may be playing a key role. Yeah, I mean, broadly speaking, this concept of precision medicine is really key here. Of course, trying to reduce the kind of the complexity around the diversity of the indication is something that we're really focused on.
Yeah.
Yeah. That's a really good point. Maybe moving into ketamine. I think the big question is always, how does our ketamine compare to Spravato? I think you touched on Florian, right? The administration could be quicker. Hopefully, you don't need to be watched. What are just kind of the high-level comparison points you'd call out there?
Yeah. The most important thing is the greater therapeutic index. That's the premise of this compound. If you look at S-ketamine, basically the therapeutic dose is the same as the dose that causes dissociative side effects and other side effects. If you go back to the summary basis of approval for that compound, you can see that certainly the dissociative effects were something that really dissuaded in part. Those are important symptoms that dissuaded the FDA from allowing at-home use. If we can get a therapeutic index, if we can get a dose that is efficacious, that is substantially less than that which causes dissociation, I think we have a very compelling argument for at-home use. Of course, that's a totally different paradigm, right? That makes things a lot more straightforward in terms of being able to address a very large market.
Yeah. Can you just remind us of kind of the existing dataset that you have with arketamine? Kind of what got you interested in the compound and how you're designing the phase II trial?
Yeah. Absolutely. The data was primarily, it was almost exclusively preclinical, right? It was, why did this even come to be? I mean, people had been interested in ketamine. They showed that it was a nice antidepressant in the early 2000s. Everybody focused on the NMDA antagonism, right? That was sort of the logical thing. That is presumably why J&J made the decision around S-ketamine, right? This is over a decade ago. Of course, the data has been more complicated since then. Some compounds have worked. Some compounds have not worked despite being NMDA antagonists. Certainly, nothing has really made it through the phase III gauntlet. That is really what prompted some investigators to go look at the other enantiomer and see what is going on there.
They found that despite being a very low-potency NMDA antagonist, it actually is a higher-potency antidepressant. In animal models, it seems to have a therapeutic index. Insofar as abuse liability is being driven by NMDA antagonist, they did find a nice separation there. It was run at multiple labs, and it was done with many different animal models or experimental paradigms. That was really quite encouraging. More recently, there was a publication, albeit a small one, a small trial that was seven subjects, open label, treatment-resistant depression. They did IV ar ketamine just like we're doing. They found a very nice response that looks very much like ketamine, but it was devoid of any kind of dissociative effect. That is currently the totality of the data. Again, a lot of it is preclinical, but nonetheless, very compelling data.
We did a phase I trial, and we had some results that we've had a poster at our presentation in September. Long and short of it is, at higher doses, it looks a lot like ketamine or S-ketamine for them. Not a big surprise there. At lower doses, it really doesn't; it's pretty devoid of any kind of dissociative activity. At the doses that were used in the previous study, we confirmed the lack of dissociative effects. We're actually moving forward to 30 and 60. Thirty had no effects from a dissociative perspective. Sixty had essentially minimal or very limited effects. Good tolerability profile overall. Those are what we're going to be testing in our phase III. Shouldn't be a shock of what the design looks like. It's double-blind, placebo-controlled, three parallel arms of those two doses plus, of course, placebo.
[Madrass] 24 hours is the primary.
Okay. Perfect. Maybe moving into one of your non-psychedelic assets where you had some news recently, RL-007, cognitive impairment associated with schizophrenia. What did you like in terms of the data you saw in this one? This one's been in humans before and a lot of people, but not necessarily tested for this indication. What kind of drew you to this asset?
I mean, the unmet need is massive. I think everybody recognizes that. I mean, this is a schizophrenia is a debilitating condition. Of course, people think of just the positive symptoms, the hallucinations, etc., but that's probably not really the driver of institutionalization and inability to work, etc. It's really the cognitive impairments and negative symptoms that really are driving a lot of that. Anything that can really address that, of course, would be huge. The data with this compound was interesting. It's a complex compound from a pharmacological perspective. Phenotypically and behaviorally in animal models, it was pro-cognitive at low doses and analgesic at high doses. In humans, a pretty similar pattern was found, even though the focus has always been on analgesia. Interestingly, in one of the phase I trials that was focused on cognition, it was a scopolamine challenge trial.
They did find this benefit on cognition, but they also found a shift in quantitative EEG. The first thing was just to make sure that we can replicate that in this population because it is such a challenging population and such a challenging indication that really kind of behooves us to spend the time to just do this somewhat more sequentially. That is what we did with this first trial. It is a biomarker-focused study. Folks with schizophrenia that are on stable doses of their meds that have cognitive impairment, which is, again, the vast majority of these individuals, dosed them for five doses, I believe, and then did sort of pre and post quantitative EEG. What we were looking for primarily was a shift, a spectral shift. From lower frequencies to higher frequencies. That was the main thing.
That was just to replicate what had been seen in normal healthy volunteers given scopolamine. Secondarily, we wanted to look at both potentials and then the next level down. It's kind of icing on the cake, but it's such a small trial. We're not putting a lot of stock in his behavior, right? Can you actually measure any kind of changes in cognition? This initial analysis was just looking at spectral shifts, quantitative EEG. Again, just eight patients. It's not huge. It was just to see whether or not there was anything that was any there there, really. We did see some compelling signals on that and just some quantitative EEG there. It was enough to at least just make the decision to move the trial, the prep work for the next trial forward.
Of course, we will have to look at the totality of data. We've got three additional cohorts, and we'll make a final decision at that point.
Okay. When you talk about kind of moving the, I guess there's this trial and there's moving the program forward, I think you have talked about it makes sense to do a phase II A given kind of the limited investigation with this asset in this patient population. Could there be something before you get to a two B, or will there be kind of a decision-making point in terms of what the next steps are within clinical development?
We are still designing that next trial. That next trial will be focused, of course, on cognition. Will it be a true 2b that sets up for the phase II meeting? That we are still debating. Again, it is nice data. It is great data that we saw so far in the first cohort, but it is quite a, if you want to formally assess cognition, typically these are quite large studies. The question is, can we do something in between at the moment to further increase our comfort level as it regards behavioral or symptomatic improvement?
Okay. That's helpful. In the last few minutes, we'll try to tick off a couple more programs. Maybe we could jump into GABA. That's one that's been getting a little bit more interest lately, the potential for GRX-917 to be an improved version of Etifoxine, which has been used historically. How should we think about that program? What gets you excited there?
Yeah. I mean, so it's a new chemical entity, of course. So it's in a phase I SAD and MAD. SAD wrapped up, and MAD is ongoing at the moment. I think the most important or most interesting piece of that trial is the quantitative EEG element there as well. Given the pharmacology of this compound, which is increasing production of neurosteroids, it allows us to start looking at certain patterns on quantitative EEG. This is entirely analogous to how Sage has approached their programs, right? They developed allopregnanolone, one of those neurosteroids, as well as derivatives of it, structural variants of it. They typically are focused on quantitative EEG, looking at beta augmentation, a particular band within the frequency spectrum on EEG. That's what they were looking for as their target engagement biomarker and as sort of an anchor for dose ranging. That's essentially what we're doing.
We actually did a trial with etifoxine, and we did, in fact, show targeting; we showed beta augmentation. We have a target, and of course, we got PK out of that trial as well for etifoxine. We have something to look back at for our 917 program, and that's exactly what we're doing now. Very excited about seeing those quantitative EEG results in addition to, of course, safety and tolerability.
Okay. Great. Maybe hopping over to Ibogaine, this is one that I think investors are familiar with from an experimental perspective, but maybe you could frame the market opportunity specifically in opioid use disorder and then some of the complications and how you're tackling them with administration of the drug.
Yeah. I mean, obviously, another naturally occurring psychedelic-like compound. I say psychedelic-like because it's not pharmacologically like a classical psychedelic. Moreover, the experience seems to be a little bit different. It's more putting you to a dream state that's pretty extended, at least eight hours, if not a little bit longer, than kind of this introspective phase that occurs for many hours after that. It's a very interesting compound. It's been particularly the use of this or the sort of the anecdotal use of this compound has really been in substance use disorders for the most part. They've shown some very interesting results. I mean, this compound, in the case of opioid use disorders, seems to really change the relationship that the patient has with the opioid as opposed to just sort of blunting cravings and things of that nature.
Again, really interesting anecdotal data, I'd say. I mean, lots of it, but still, there's no double-blind placebo-controlled trials here. That's what really got us excited. The target population that we're looking at is really those folks that are being detoxed on an inpatient basis, really being transitioned to nothing, which is different than necessarily from being transitioned to buprenorphine or something. These are people that are really being taken off any kind of support. It's an existing paradigm, which is nice. We don't have to build out a clinic chain. I mean, there's already over 650 of these sort of clinics, these sort of facilities, I should say. This is just laying this on top, essentially.
The way this works is the patient comes in, they're either transitioned to a short-acting opioid or not, but then they're basically completely cut cold turkey at that point. Their withdrawal symptoms are managed. Essentially, what we're doing is that standard of care, we're just going to overlay the Ibogaine on top of that. They're usually monitored for several days afterwards, which, of course, would be completely appropriate with this compound.
Yeah. Okay. In the last minute, maybe just turning back to you guys, anything we missed that's particularly topical with investors or that you'd want to get across?
I mean, just again, this focus on our digital therapeutics is being really kind of critical to a lot of what we're doing. It's something that does need to be brought up one more time. We did announce Introspect a while ago, and of course, that's moving along. We're in a UAT user acceptability testing study now. We'll have more to announce later on that front. With Psyber, that's moving quite well in terms of hardware. We'll be deploying both of these technologies into our phase I and II trials that will be kicking off next year. Pretty excited about that.
Great. Okay. With that, I think we're bumping up against time. Thank you very much for the participation. We could keep going, but we got to cut it off somewhere. Thanks, guys, and we'll talk soon.
All right. Thank you.
Thank you. Take care, everyone.
Thank you.