AtaiBeckley Inc. (ATAI) Earnings Call Transcript & Summary

Hi, everyone, and welcome to day 4 of the 2021 Credit Suisse Healthcare Conference. I'm Judah Frommer. I cover biotech here at CS. And we're thrilled to have a tie with us. There's been some news in the space that we'll get into. But 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. And I figure we could just jump right into Q&A before we get to the news of the week. Maybe you could just first, talk about the data platform. And maybe a good place to start is just the level of unmet need in neurocyte and mental health and what the impetus was for creating the platform.

Sure. I'm happy to. Thanks for inviting us over to a little bit on our story and also the founding story that you mentioned because our -- 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 or not finding any help or healing in the system that alludes to the significant unmet need that you mentioned. And what we realized is not only that the treatment options are, yes, so insufficient today. So we don't have any really rapid acting and durable effects when it comes to antidepressants for instance. So seeing the friends and family members going through this journey realized or made us realize that there needs to be more innovation in this space and that we need to do more. And it also made us realize how large that problem is indeed. So it's really 1 billion people globally suffering from mental health disorders, and that's the diagnosed cases. Mental health is still very much stigmatized. So you could also assume that these numbers, in fact, quite higher. So we really start 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. And there are multiple assets within the platform. How should we think about kind of this balance of -- I think people 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? And is there a mission to go after psychedelics? Or is that just one aspect of the portfolio in a way to address unmet need?

Yes. That's a very, very interesting question. So I guess it really goes back also here to the founding story, to me, basically saw for some 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, [Indiscernible] psychedelic psychotherapy was what really helped him through this phase in a very, very sustainable way. So that was the starting point, and that's why we were initially intrigued in the group of psychedelic, compound group of psychedelic triptans to really in a rigorous way research the potential of these compounds in neurosis. And from there, quickly realized also when Srini came on board that there is so much more interesting innovation potential pharmacology, but also digital approaches out there that can equally has a -- can have a really significant impact once approved for patients. So what's interesting -- so 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. And ideally, there's also an angle of potentially disease-modifying angle. Something that, of course, in your side hasn't been really achieved over the last decades. So 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.

Yes. Yes, it certainly does. And 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?

Yes. No, happy to. So -- on the compound selection side, so whenever we onboard a new program or onboarded a new program in the past, for us, it was important that given the historically rather low likelihood of successes that we are designing in an operating model with the intention to really increase that likelihood of success. And basically, we applied kind of a 3-layered approach. On an asset level, we're looking and are still looking at compounds with prior evidence in humans. So that means that we have a good understanding of the safety profile that and at least anecdotally or biomarker signals pointing to the efficacy of the compound in the respective indication. And that holds true for psychodelic and non-psychodelic compounds. So that's a very important part on the asset level or in the compound level. And then we're basically applying a very staggered or milestone-based approach to capital allocation. And that is also rooted in how we're developing those compounds. So we usually form a company around the IP, the compound when we incubate the company. When we acquire a company, we want to -- yes, we basically also don't fully integrate it into a type, but keep the founders incentivized in an entrepreneurial way. So we usually have a majority ownerships. But the delta of -- 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 focused on their program to execute in their name that on the compound indication that they're set out with. And then 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. So basically on that way to POC identify together with them based on the clinical development plan, value inflection points. And when they hit, we provide additional funding. And when they're not hit, then that allows us as a tie also to reallocate funds to areas where we believe we have a higher ROI and a higher likelihood of success. So that allows us real truth-seeking approach versus a success-seeking approach. And the portfolio element that's in the third layer, so you mentioned we have -- we're not a one asset buyer company. We have a portfolio approach a platform approach developing multiple compounds for multiple indications with a truly differentiated pharmacology with respect to the asset compounds that we're developing, that approach in itself also contributes us allowing -- yes, that allows us to take greater risks as it's nonbinary. And we can be more also here truth seeking very success seeking unlike one asset biocompany.

Yes, that makes a lot of sense. And 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. So 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. So clearly, the concept of developing compounds that don't have composition of matter patents isn't new, right? There's many compounds that fall into that class, many naturally occurring compounds, right? So fish oils, for example, Lovaza and Vascepa comes to mind. So there is obviously a lot of precedent here. I mean there's lots of different angles that one could use. Certainly, you have [Indiscernible] chemical entity, but -- and the provision for the 30-month stay on the strictly IP front, you have beyond competition matter of method of treatment claims. You have a lot of competition matter potentially around some aspects of chemistry, right? So crystals and polymer salt forms and things can provide pretty solid ability to block depending on their applications, particularly vis-a-vis manufacturer of those compounds. There are a lot of things that I usually refer to as label claims. I mean when you're -- they come that refer to things like the dose, the dosage, the frequency of dosing, the sort of the constraints around dosing. That I think is a really rich area for compounds that are psychodelic, right? Because the dosing paradigm is very complicated. It's very different than what is useful than popping a pill every morning or maybe twice a day. So there's lots of avenues around that. Obviously, that requires some data. And as that gets pulled in, of course, that will change. And of course, we'll talk about COMPASS here in a little bit. Another critical element from our perspective is, in fact, the digital therapeutics. So it should be noted for the naturally occurring compounds the psychedelic compounds that we're developing, we're building a digital wrap around it, building these things as putting these together and developing them as combination products. So 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 cyber. Obviously, provides a whole another level of protection, right? Just even if no part of that was patent protected, it's so very hard to take those 2 things apart. And of course, we will have -- we have patents filed and we have a number of patents issued on our digital therapeutics as well, so that also provides a pretty important ability to back. Last comment is that we are viewing these as generations, right? So we have naturally occurring first-generation compounds now in the context of a [ antigenics ], for example, we're already -- we've got completely new chemical entities. We've generated 250, actually closer to 300 compounds at this point. Completely new scaffold, is not seen before, very high potency, very good selectivity. So 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. And 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.

Yes. So sorry [Indiscernible] very pleased to chime in. So I think what's important and probably, as Srini already mentioned, our approach, I guess, as part of the IP and also all the second-generation compounds that we're developing, we really developed with kind of this commercialization angle in mind. So with the greatest hurdles if you have psychedelic-assisted therapy is how do you scale this? How do you get this out to to as many patients as possible. To your point, there has been with SPRAVATO already a compound that is associated of -- that has to be administered in an inpatient setting. So 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 in to that existing paradigm. So not to reinvent [ missly ] create multiple treatment paradigms that you have to kind of each build out on its own, but it's just leverage an existing platform. so that we can achieve a scale that also benefits patients ultimately as they can access it also in an easier way. And that treatment window is that 2 hours. So we were designing the compounds to have a duration of effect of 45 to 1 hour -- 45 minutes to 1 hour, to really slot into this paradigm. And we have seen a good development over the last years, luckily. So have a critical infrastructure now in place. In our perspective, we are still a little bit out from commercialization stage. So 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 yes, is doing the research and potentially will partner going forward and have the optionality also to be involved on the commercial side, but we believe that we'll not necessarily involve kind of brick-and-mortar clinics. Yes, Srini, I don't know if you want to kind of chime in on that one.

Yes. 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 arcetamine, it's a little less critical. We're really developing that for at-home use. But for the true psychodelic compounds, as Florian pointed out, because of the pharmacokinetics of DMT as well as the Southern RNA, we can actually use formulation technologies really kind of limit the duration of psychodelic effect pretty significantly. It's too as well as 20 minutes. But in our case, looking really right around 45 minutes of the time frame. And again, to sort of slot into what J&J is already building there. And 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 the duration of psychodelic effect and durability of response. It's a very interesting question and something that obviously we -- once we start developing these compounds, we'll get some insights on. But the way we're structuring it is through our digital application, we kind of always assume that there will be some redosing, right? So it's always been the assumption that because of the shorter duration of psychedelic effect, you'll have to redose more frequently. But we don't necessarily want this on a fixed schedule. So in time, maybe not the next drop, 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. So as you're probably aware, that means on a fixed redose schedule. It's twice a week 4 weeks and once a week for 4 weeks. We'd like to go to walk away from that a little bit, adapt it to the patient.

That makes a lot of sense. And speaking of durability, maybe we could jump into specific assets here, and we'll start obviously with the COMP360 readout earlier this week. I think heading into this readout, I think you guys had spoken a bunch about assessing rapidity of onset and durability as being 2 kind of key areas you'd be looking at. So maybe we can start there. Kind of what did you see? Maybe you can work in kind of a dose dependency as well, but important for psychodelics is obviously that they were quickly, but you want to see them them last for a while, too. So what do you see there?

Yes. I mean it's always good to see the results replicate in a robust trial, right? So I mean I think that's the most important thing. The trial hit its primary endpoint and hit it quite well, right? So that was obviously pretty critical to this compound in this space. The rapidity of efficacy was also very encouraging, right? So it really nailed the 24 hours out. Previous demonstrations had not been quite so precise or as rigorous, let's put it that way, right? So this was a really robust effect that it was going 24 hours out. As we've discussed, one of the -- in the past that one of the important differentiators of [ silosivans ] as a durability of response, right? So a single administration lasting for weeks, months. And once again, we saw that in this -- in the context of this compound. We in this trial, we saw roughly over 2x improvements in remission scores and response scores as a function even out of 12 weeks. So once again, I think all of the primary things were hit. There's a lot -- there's learnings here, of course, in terms of dose ranging and stuff. How to think about when a patient needs to be redosed, et cetera, things that we'll need to be -- we'll have to dig into these data a little bit more to truly understand that. But the fundamental the investment thesis around [ silosivans ] I think, was optimally met with this trial.

Yes. That makes a lot of sense. And just on the safety side of things, obviously, it's a tough population to kind of delineate safety signals in. So what do you see there? What kind of encouraged you on that side?

I mean there was really nothing that was unexpected there, really, right? So I know people have made some hair around the suicidal behaviors and ideation and things that that seems to be not necessarily does relate I mean, well, it seems to be more heavily skewed towards the higher dose. The ends are small. I think it's worth emphasizing that. And so we will have to see how this progresses. Per the call with the management team, the statement was made at these are people that we didn't respond, right? So the ones that took the 25 milligrams, didn't respond. I guess, in that context, it also makes sense. I mean we can't anticipate linking you shouldn't expect everybody to respond. And of course, those that didn't -- will continue to have a tough course, right? So these are behaviors you'd anticipate in this patient population, right? So as for the dose response, let's see how that plays out over the course of the subsequent trials.

Yes. So -- yes, 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. What do you -- assuming everything goes well there and that's largely housekeeping, what do you hope to kind of discover further as you move into ideally Phase III? Is it dose? Is it durability? What kind of -- what are the specific questions you're still hoping to have answered more clearly?

Well, I mean, obviously, we're not privy to those discussions that COMPASS is having both internally and with the FDA, right? So this is all just public guidance, of course. So again, just stepping back in like the data -- the limited data, should we know that is 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? And they tend to -- they may not have been as rigorous as one would like, certainly as one would anticipate for an industry-sponsored trial. So 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.

Yes, that makes sense. And we should mention you guys have I think that it's still a 19% plus stake in COMPASS officially. But the broader read-through here was always going to be to psychedelic drug development, right? So what do you see in terms of read-throughs, maybe not necessarily to specific assets within your wear platform, maybe it is to specific assets, but maybe more generally in terms of moving the field forward.

Well, again, 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? So this is 3 weeks out from administration. Just ponder that for a second because that's never been demonstrated previously and certainly not this robustly. I mean [Indiscernible] really never went out beyond a week. A couple of studies may have looked at about 14 days, but that was really about to hit the primary [ serobus ] at 21 days was pretty remarkable. So 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 sort of therapy that was involved. Obviously, has important implications for us, we're thinking through our Phase II trials in light of these data. And 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 are going to play an important part of that, of course, short duration likely makes things easier, this hypothesis that we have to test. But the requirements for cider are probably a lot lower, and we want to be able to do this digitally, so to speak, and we have cyber, which is developing hardware for this. Ultimately, that will provide a digital guide. And with sort of built-in capability as well as potentially telemedicine, et cetera. So we've got a lot of different angles here that I think really do -- I mean, they build on the story quite well.

To add to this very briefly. I think it's also important to realize that -- or to emphasize that some people were like very much maybe even overexcited and looking at psychedelic like a panacea, right? We purposefully designed 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. So I think that's important to mention. So yes, that we have a wide array of tools available for patients and that there is most likely not this one compound that -- or with this one therapy that everyone will respond to, hence, also our approach and also the importance to look at 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.

Yes, that's a really excellent point. I mean, so we -- in terms of psychedelics, we've got at least 3, right, 3 different pharmacologies. So we've certainly got DMT that shares a lot of overlap with psilocybin, but we've also got an RNA, which really doesn't ibogaine is completely unique onto itself. And then arcadamine 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 give a patient will respond to, but that's obviously something that we want to generate over the course of time. And in terms of precision medicine, I mean, certainly, there's a lot of interest in that, and 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 a remark that is one of the leaders in the metabolomics space and formed. I mean she was the founder of metabolome outside of our academic appointments. So we're partnering with them for a precision psychiatry approach non-psychedelic but really focusing on particular subsets of the treatment-resistant depression population, where in mitochondrial energetics may be playing a key role. So yes, I mean, broadly speaking, this concept of precision medicine is really key here. And of course, trying to reduce the kind of the complexity around the diversity indication is something that we're really focused on.

Yes. That's a really good point. And maybe moving into ketamine. So I think the big question is always how does our ketamine compare to SPRAVATO. I think you touched on, Florian, like the administration could be quicker hopefully, you don't need to be watched. But what are just kind of the high-level comparison points you'd call out there?

Yes. The most important thing is a greater therapeutic index. That's the premise of this compound. So if you look at esketamine, basically, the therapeutic dose is the same as the dose that causes associated side effects and other side effects. And that's -- if you go back to the summary basis of approval for that compound, you can see that certainly the associated effects was something that really dissuaded in part, but those are important symptoms that dissuaded the FDA from allowing at-home use. So 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. And of course, that's a totally different paradigm, right? That makes makes things a lot more straightforward in terms of being able to address a very large market.

Yes. And can you just remind us of kind of the existing data set that you have with our currently, I mean kind of what got you interested in the compound and how you're designing the Phase II trial?

Yes, absolutely. So the data was primarily -- was almost exclusively preclinical, right? So it was, why did this even come to be? I mean people have been interested in ketamine they showed that it was a nice enterprise in the early 2000s. And then everybody focused on the NMDA antagonism right? That was sort of the logical thing, and that's presumably why esketamine well, why the J&J made a decision on esketamine this is over a decade ago. But of course, the data has been more complicated since then. Some compounds have worked, some compounds have not worked despite being NMDA antagonist or certainly nothing is really made it through the Phase III onward. So that's really what prompted some investigators go look at the other in [Indiscernible] see what's going on there. And they found that despite being a very low potency NMDA antagonist, it actually is a higher potency anti-depressant. And in animal models, it seems to have a therapeutic index in so far as abuse liability is being driven by anti antagonism, they did find a nice separation there. It was run at multiple labs, and it was done with many different animal models or experimental paradigm. So that was really quite encouraging. And then more recently, there was a publication, albeit a small one, a small trial, there was 7 subjects, open label, treatment resistant depression. And they did IV parade just like we're doing. And they found a very nice response that looks very much like ketamine but it was devoid of any kind of dissociated effect. So that's currently the totality of the data. Again, a lot of it is preclinical, but then also very compelling data. We did a Phase I trial, and we had some results that we had a poster at our presentation in September. But long and short of it is the -- at higher doses, it looks a lot like ketamine or esketamine. I don't know a big surprise there. At lower doses, it really doesn't -- it's pretty good void of any kind of dissociative activity. The doses that were used in the previous study was that we confirmed the lack of dissociative effects. So we're actually moving forward with 30 and 60. 30 had no effects on it from an dissociative perspective, 60 had essentially minimal or very limited effects, good tolerability profile overall. So those are what we're going to be testing in our Phase III, shouldn't be a shock or what the design looks like it's double-blind, placebo-controlled, 3 parallel arms of those 2 doses plus, of course, placebo, MADRS 24 hours is the primary.

Okay. Perfect. And maybe moving into one of your nonpsychedelic assets where you had some news recently, RO 007 cognitive impairment associated with schizophrenia. So what did you like in terms of the data you saw in this one. This one has been in humans before and a lot of people, but not necessarily tested for this indication. So what kind of drew you to this asset?

Well, I mean, the unmet need is massive. I think everybody recognizes that. I mean this is a -- schizophrenia is debilitating condition. And of course, people think of just the positive symptoms, the hallucinations, et cetera, but that's probably not really the driver of institutionalization and inability to work, et cetera. It's really the cognitive impairments and negative symptoms that really are driving a lot about. So anything that can really address that, of course, would be huge. The data with this compound was interesting. It was -- it's a complex compound from a pharmacological perspective, but phenotypically and behaviorally in animal models that was procognitive low doses and analgesic at high doses. In human is a pretty similar pattern was found, even though the focus has always been on analgesia. And interestingly, in one of the Phase I trials that was focused on cognition as a scopolamine challenge trial that did find this benefit on cognition, but they also found a shift in quantitative EEG. So 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 moves us to spend the time to just do this somewhat more sequentially. So that's what we did with this first trial. It's a biomarker-focused study, folks at schizophrenia that are on stable doses of their meds that have cognitive impairment, which is, again, the vast majority of these individuals. Dose them for 5 doses, I believe, and then sort of pre and post quantitative EEG. And what we were looking for primarily was a shift -- a spectral shift. So from lower frequencies to higher frequencies, that was the main thing. And that was just to replicate what have been seen in normal healthy volunteers given scopolamine. Secondarily, we want 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 are not putting a lot of stock in this behavior, right? Can you actually measure any kind of changes in cognition. So this initial analysis was just looking at spectral shifts, quantitative EEG. Again, just 8 patients. It's not huge. It was just to see whether or not there is anything that would any there really. And we did see some compelling signals on that and just in quantitative EEG there. And it was enough to at least make the decision to move the trial, the prep work for the next trial forward. But of course, we will have to look at the totality of data. We've got 3 additional cohorts, and we'll make a final decision at that point.

Okay. And when you talk about -- kind of moving the -- well, I guess there's this trial, and there's going to be the program forward. I think you have talked about makes sense to do a Phase IIa, given kind of the limited investigation in this -- with this asset in this patient population. Could there be something before you get to a IIb or will there be kind of a decision-making point in terms of what the next steps are within clinical development?

So we are still designing that next trial, but that next trial will be focused, of course, on cognition. Will it be a Tru2b that sets up for in the Phase II meeting, that we're still debating. It's -- again, it's nice data. It's great data that we saw so far in the first cohort, but it's quite a if you want to formally assess cognition, typically, these are quite large studies. And the question is, can we do something in between at the moment to further increase our comfort level as it regards to behavior or symptomatic improvement.

Okay. That's helpful. And 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 interestingly, the potential for GRX 971 to be an improved version of etifoxine, which has been used historically. So how should we think about that program? What gets you excited there?

Yes. I mean, so that's -- it's a new chemical entity, of course. So it's in a Phase I SAD MAD, SAD wrapped up and MAD is ongoing at the moment. I think the most important and most interesting piece of that trial is the quantitative EEG element there as well. So given the pharmacology of this compound, which is increasing production of neurosteroids, it allows us to start looking at certain patterns of quantitative EEG. This is entirely analogous to how Sage has approached their programs, right? So they developed allopregnanolone, one of those neurosteroids as well as derivatives of it, structural variance of it. And they typically have focused on quantitative EEG looking at beta augmentation, a particular bandwidth in the frequency spectrum on EEG that's what they were looking for is their target engagement biomarker and as serving anchor for dose ranging. And that's essentially what we're doing. We actually did a trial without etifoxine and we did, in fact, show targeting -- we showed data augmentation. And so we have a target, and of course, we've got PK out of that trial as well etifoxine. So we have something to look back at for our 917 program, and that's exactly what we're doing now. So very excited about seeing those quantitative EEG results in addition to, of course, safety and tolerability.

Okay. Great. And then 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.

Yes. So I mean, obviously, another naturally occurring psychedelic-like compound, and I say psychedelic-like because it's not pharmacologically like a cost called psychedelic -- And 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 8 hours, if not a little bit longer and then kind of this introspective phrase that occurs for many hours after that. So it's a very interesting compound. It's been particularly the use of this or the sort of the nexus of this compound has really been in substance use disorders for the most part. And they've shown some very interesting results. I mean this compound in the case of opioid use disorder 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. So again, really interesting anecdotal data, I'd say, I mean, lots of it, but still there's no double 1 placebo-controlled trials here. But that's what really got us excited. And 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. And 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. So this is just laying this on top, essentially. So 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. And then there's -- withdrawal symptoms are managed. And essentially what we're doing is that standard of care, we're just going to overlay. Yes, I began on top of that. They're usually monitored for several days after which, of course, would be completely appropriate with this compound.

Yes. Okay. In the last minute, actually maybe just turn it back to you guys. Anything we missed that's particularly topical with investors or that you'd want to get across?

Well, I mean, just again, this focus on our digital therapeutics has 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. So we did announce Introspect a while ago. And of course, that's moving along. We are in a UAT user acceptability testing study now. We'll have more to announce later on that front. And with cyber, that's moving quite well in terms of hardware. We'll be deploying both of these technologies into our Phase I/II trials that will be kicking off next year. So pretty excited about that.

Great. Okay. With that, I think we're bumping up against time. So thank you very much for the participation. We could keep going, but we got to turn it off somewhere. So thanks, guys, and we'll talk soon.

All right.

Thank you so much.

Take care, everyone.

Thank you.