Good morning, everyone. I'm Sumanth Kulkarni, a senior biotechnology analyst at here at Canaccord Genuity, and it's my pleasure to have Atai here with us today. Atai is a mental health-focused company, and as you know, mental health is is really a crisis, and there's not too many companies taking it on in the at the scale at which Atai is attempting to take this on. So for that, we thank you, and thanks for making the time here. We have our Co-CEO, Srini Rao, with us today. So I'll turn it over to Srini to make a few opening remarks, and then we'll go straight into Q&A. Perfect. Yeah, thank you so much, Sumanth, for having me here. As Sumanth indicated, we are focused on mental health. We have a pipeline currently of seven assets that are in clinical development, that range from basically phase IIb all the way down to phase I, looking at cognitive impairment associated with schizophrenia, multiple assets, and treatment-resistant depression. Recently announced that we're pursuing social anxiety disorder with one of our assets and also looking at opioid use disorder. There's quite a bit going on, lots of readouts over the course of the next 18 months or so. So I'll start with one of your trials. It's a Beckley product, BPL-003. You had really interesting phase II data, and there's another phase II that's coming. We now know that you expect to complete that trial or patient enrollment by the end of this year. When could we see data on that? Yeah. So, the next steps on that—s o, as you said, we, you know, it's an asset that we're looking at for treatment-resistant depression. We had a phase IIa that was open label, gave some really nice directional data in terms of durability, so, you know, increased our pre-test probability for a large double-blind, placebo-controlled trial. That trial, the guidance has been that we'll be completing enrollment at the end of this year. The plan is to basically PR when the last patient's enrolled, and then, of course, from there, we can, we'll be able to give some more guidance as to when top-line will be available. Got it. So that could be a, like, a 2025 event? It's— I mean, we've given ourselves a little bit of latitude there, so it's around the end of the year is kind of where we're— Okay. What we're thinking. Understood. Yeah. So it would be remiss of me. Actually, I should have started with this, but, let's go back to Lykos. It's, it's kind of the topic of the day on psychedelic therapeutics, and we saw what happened with the unfortunate FDA outcome there. How does that—y eah, I think those were Lykos-specific issues, but how does that whole experience help you in learning on what to do right with all your programs? Yeah, it's obviously, it's a great question. It's something that's come up a fair amount over the last little bit. So, you know, just to keep, get everybody up to speed, Lykos had submitted an NDA for MDMA for the treatment of PTSD. It was a very atypical package that was submitted, and the PDUFA date was actually on Sunday, but they got their response on Friday, which was a CRL requiring another phase III trial. So, you know, of the potential outcomes, this was, to me, I mean, it was, you know, it was pretty high probability as a CRL, just, you know, looking at the direction that things went. Also, looking at their trials, right? They were small studies, and essentially, what we anticipate the agency has asked for is a more traditional phase III trial to kind of bolster and augment what they did. Obviously, it's had some reverberations in the space, but again, a lot of this has been specific to Lykos, and in fact, SPRAVATO was approved as a psychedelic-adjacent compound, if you will, and that was approved in 2019, sailed through advisory committee, sailed through the approval process as well, first round approval. So, I view SPRAVATO as being more the predicate here. Now, in terms of what we—y ou know, in terms of learnings, I mean, clearly, this—because one of the strange things about it is they positioned it as MDMA-assisted therapy. Right. Which is a little strange in terms of construction because the FDA doesn't regulate therapy. Now, certainly, there have been approvals, for example, in the opioid space for medication-assisted therapy. It's on top of standard care. That's a known approach to developing drugs. Here, they actually came up with the novel therapy, and then, so that's inactive, if you will, and then they had an active drug. So, of course, that's something that we and other companies have been avoiding. You know, really, the focus on therapy is not something that, you know, we put much stock on at this point. I'm glad you brought up the classic examples, SPRAVATO, right? There's been a lot of, lot of discussion around functional unblinding. Yeah. Clearly, that's never been an impediment to product approval, as long as the trial is done right. If you had to get by that functional unblinding issue, quote-unquote, would that be done by establishing good dose dependence? Yeah. That's certainly part of it, right? So dose dependence is an important element of that. Durability of response is another really important element. So, the argument being that—y ou know, so, actually, COMPASS did a very nice job already in their phase IIb trial. So they compared 1 mg to 10 mg, to 25 mg, 1 mg being the functional placebo, if you will, in this case. And what they found is that the 10 mg, that which was robustly psychedelic, did not have the same efficacy as 25, did not separate from the 1 mg dose statistically. So they showed that it was independent of the psychedelic product, and they also showed durability. The argument being that if it's just due to functional unblinding, these are treatment-resistant patients, it'll go back to baseline more rapidly. So they did a nice job with that. That's absolutely an important element of what we and other companies are doing. Another important point of distinction here is that there was functional unblinding of the patients, which is a known phenomenon. But in the case of Lykos, there was functional unblinding of therapists, and that was a bit more problematic. So I mentioned the therapy's kind of, you know, it was ad hoc. It was also not particularly standardized, so there was a lot of latitude for each therapist in terms of what they could do, and they were actually sitting with the patient while they were undergoing the psychedelic or psychedelic-related experience— they could then change. They will, of course, being humans, will change their response and how they approach therapy with those patients. So again, lots of nuance here that made it very difficult to assess the independent efficacy of the drug. And then there were other issues on the safety side, that there were inadequate collection of data, small sample size. So assessing risk also turned out to be challenging. Got it. So we'll get back to the atai pipeline now. Yeah. VLS-01 had a promising phase I data in healthy volunteers. I think people sometimes underestimate the importance of formulation and things like that. Yeah. This is a transmucosal film, an oral film. You said you had a short psychedelic experience. Given that this is an oral transmucosal film, is there any difference in the quality of the experience that one might have versus the other routes of dosing? So that's a great question. You know, there's a lot of anecdotes around, you know, the experience, the subjective experience with 5-methoxy-DMT and DMT. There is. You know, one of the factors here is, of course, pharmacokinetics, and I think that's kind of what you're getting at. So if you inhale it, it's a very different experience for DMT than if you take it as ayahuasca. So ayahu— you know, DMT is the active in ayahuasca. There, the experience is closer to, you know, 5, 6 hours. So here we have roughly 2 hours, not a super abrupt pharmacokinetic, you know, a rate of rise. So it's the subjects in the trial, particularly the dose that we are moving forward into phase II, found it to be a very useful, very helpful, and positive experience for them. These are subjects. They're not patients. So if you inhale it, you basically end up snowing the patient, right? So, particularly if it's pulmonary inhalation or I V push, same, same concept. Yeah, basically, the patient is kind of out of it. We have patients who were, you know, arousal all the way through. We actually asked them the intensity of the experience, and they were able, they were able to answer that question. If you inhale or push a large amount, that doesn't really occur. What could that mean to the durability of the treatment effect? Right. So that's something that we need to get data on. I mean, I think that's a short answer to it. So we have two data sets that'll give us some real insights on that. Right. So we have the BPL-003 data set. That's a phase IIb that'll be generating results. We talked about that, so we'll have that soon. That's a single administration with eight weeks of follow-up. So a single administration that's blinded, and we can get a sense of how long it lasts. We just announced, well, we talked about more publicly the VLS-01 phase II design, and there we actually have two doses. Yep. We will—y ou know, because we might as well answer some different questions with this trial than the BPL-003 trial. You know, they're different compounds, but they're both short acting. So there we'll get a sense of what's the additive benefit, and again, 12 weeks of follow-up there. Okay. What made you choose treatment-resistant depression, or TRD, as an indication versus going after a broader MDD population or major depressive disorder? Yeah, so it's interesting right now. By the time you get to a psychedelic or even to a branded product you know, it's the patient population that you're looking at is functionally treatment-resistant. Right. Right? So the standard of care is a patient comes in, they're given an SSRI. You wait for a while, usually around two months or so. Then if that didn't work, you give them something else, something to augment it. That could be buspirone. That could be an atypical antipsychotic as an add-on. There's a few other choices as well. Wait another eight weeks and see if that works. So now, by definition, they are treatment-resistant. So treatment-resistant depression is y ou've failed two adequate courses of therapy in the current episode of depression. So, it's actually kind of the same thing. Right. We know if you look at literature, that folks with true treatment-resistant depression that have failed, again, two courses, have much higher healthcare utilization, et cetera. There are some pricing arguments for why one should pursue treatment-resistant versus MDD. Right. How about from a clinical trial perspective? Because we saw COMPASS, right? You have two different ballgames in Europe versus the U.S. Because Europe tends to be a more centralized healthcare system, it is much easier to identify someone who's failed two courses of therapeutics versus in the U.S., where systems are more fragmented, and you saw a little bit of a push out on the timeline for COMPASS on their trial because of that. They wanted to get the right patient in, right? Yeah. Which is commendable because you do want to get the right patient in. How—w hat's that going to mean for your TRD program, that kind of logistical hurdle? I mean, I think, you know, that's a fair point, that there's, you know, there's certainly more literature review or, you know, a chart review, I should say, for each individual patient, to ensure that they meet screening criteria. Generally speaking, that's pretty limited. It's not adding a ton more. It is a smaller population of patients. Because again, in a clinical trial situation, you can pick and choose, right? Yeah. Someone that could have their very first depressive episode could walk into the trial. In the real world, there won't be. It'll be the same thing. I mean, TRD and MDD in this context with a branded product will probably be exactly the same thing. Got it. And conceptual question: You have 5-MeO-DMT, that's the BPL-003 product. You have DMT, which is VLS-01. Is there a type of patient that might be better suited to one versus the other? The short answer is we don't know yet, right? So there's a couple of differences between those products. I mean, the API, the drug substance itself, as you point out, it's two different compounds. The two different compounds have different pharmacology. So 5-methoxy-DMT has different receptor binding. It actually is more focused on 5-HT1A; 5-HT2A is where the psychedelic effects are thought to come from. But the products themselves are different, right? So one is they're both transmucosal. One is intranasal transmucosal the other one is an oral transmucosal. So there may be preferences by the patients as well. Mm-hmm. Got it. BPL is, you know, obviously a little bit further along as well. Sure. It's about a year, and change, ahead. Yep. Which one would be the shorter experience or more intense one? I'd say they're pretty comparable at this point. It obviously depends a great deal on dosing. I will say that the dose that we are moving forward with in our phase II, 120 mg, was well tolerated. In fact, it has the potential to be best in class because we only had 1 out of 14 subjects report nausea, no vomiting. One of the lower rates on headaches as well, no local effects, no local tolerability concerns. It was well, again, very well tolerated. So yeah. Okay. How long do you think it would take for your phase II trial with VLS-01 to read out? We're currently guiding that we'll have top line around the end of next year. Just going back to BPL-003, you expect to finish patient enrollment by the end of this year. You're allowing yourself some time to figure out exactly when you could report the data. So, is there a situation where we could see top-line data on your primary endpoint, as well as durability data at the same, in the same release? I don't know what the details of that are at this moment. I don't think we've fully mapped that out, but it would be fairly typical to kind of provide those data. So, don't want to commit to it at the moment, but I think that's a, you know, primary, plus a couple of key secondaries is pretty standard. Got it. So, there's a chance we could see some durability data that exceeds that timeline? Yeah. Okay. Moving on to EMP-01, it's R-MDMA. Yeah. Could you compare and contrast that with the regular MDMA? Yep. So, yeah, it was. You know, our initial hypothesis around going after the R enantiomer was that it was going to be better tolerated than the racemic mixture, and the reason for that is S-MDMA is really more of a stimulant. Yeah. It's got more dopaminergic activity, it looks a lot like a stimulant. So, folks with PTSD do have more cardiovascular risk factors, obviously, a concern then with something that's a stimulant. So, that was the initial hypothesis. What we found in the phase I was that the compound was just remarkably different. We actually found that it has characteristics of a psychedelic compound. Now, part of this is because we are able to push the dose, right? So, the dose of MDMA is around 150 mg. And that's obviously only 75 mg of R-MDMA. So, you know, 225 mg is incredibly well tolerated. At that point, we were starting to see these... Well, lower than that. We were starting to see psychedelic effects. And it was just this curious mix of MDMA-like properties and psychedelic-like properties, but even the psychedelic properties were atypical. You know, there was this notion that there was visual changes, but the visual changes were different than what you see with psilocybin, for example. They were reframing of the patient's life or the subject's life, in this case. So, it was a really interesting profile. We spent some time thinking about it. Of course, there was no clarity on MAPS at that time, or Lykos, I should say, where that was going to head. But some of the features that we saw around self-compassion, et cetera, suggest that there may be other indications that would also be amenable to this product, and that's how we ended up going after social anxiety disorder. Yep. That was going to be my question. Yeah. Just give us some more color around social anxiety. What would be a primary outcome on that trial? So there are a couple of approvals. Yep. They're just really old. Yes. So, and there's a couple of different ways to pursue Social Anxiety Disorder. You can do it kind of acutely, and this, Vistagen is a company that's doing that w here you are looking at, you know, episodic or something that's, you know, that you're going out to a party, or you've got a public speaking engagement or something, and then you would just, in that case, you'd spray it. And so, there's an endpoint called SUDS for that. In the context of more chronic, social anxiety disorder, there's something called the LSAS, the Liebowitz Social Anxiety Scale, regulatory endpoint. The FDA is comfortable with that. It adds, asks a broad range of questions, two-week lookback period across a number of different kind of scenarios and how you would react to that. Right. So, this would be for a more chronic version of social anxiety, because clearly, you can't take this product and do a talk like this. No, I don't think that would be well advised. Maybe, I don't know. Maybe it helps. I have no idea. So chronic social anxiety disorder on that, how would you strike the market there? You have social anxiety disorder, acute versus chronic. Could you fractionate that? Yeah, I mean, I think that. So, there are some subtypes, obviously, social anxiety disorder, but it's really, for many individuals, it's a chronic condition, right? There are things that exacerbate it. Again, going to a party is one of those things that could exacerbate it, but and make it intolerable. But basically, what these folks end up doing is they avoid all these situations, and in avoiding these situations, it has an adverse impact on the quality of their life, right? Being holed up on a Friday night is maybe not the best thing and for mental health, right? So, I think they're kind of one and the same in many ways, and so obviously, what we're looking for, kind of like with MDMA and PTSD, is giving the product once or twice, in our case, with our phase II, it's twice. And then seeing how that looks in terms of durability, how it impacts their long-term, you know, reaction to social situations. How long would a session with EMP-01 last? So it's comparable to what you see with MDMA right now, because it's also oral. So MDMA and psilocybin are on the order of 5, 6 hours. Now, there are some avenues that we're looking at in terms of formulation that could bring that in. It's never gonna be 2 hours, but it could certainly bring it in, sort of in the 4-hour range. Got it. Something we're looking at, though. Yeah. And how would one measure durability in that context, in terms of a clinical trial? Yeah. So not that dissimilar to what we're doing with depression. So, you follow the patient out, and you can assess the LSAS way out at 12 weeks, as an example. Yeah. And then, of course, in subsequent trials, it would be even longer, so. Got it— and then why social anxiety versus generalized anxiety? There's just a lot less going on in social anxiety. On the other hand, it's got a huge unmet medical need, right? So there's a couple of approvals, SSRIs, and one SNRI, I believe. The last one was in 2003, so it's been a while. I don't know how much of an appreciation there has been over the years for social anxiety disorder in terms of its impact. Certainly, COVID has brought it to the fore, and particularly in younger individuals, right? I can speak to it myself, and I have three kids, one of which started high school when COVID hit, and it was really problematic for him. It remains problematic for him. These are kind of key years to develop, you know, your social skills. This is something that's going to be carried forward for some time, and it's kind of where depression was a while back, like a decade ago. Yep. So, lots of unmet need, recognition of that unmet need, but not a lot being developed for it. Got it. Do you expect to collect any depression-related measures during your social anxiety trials? In general, we would, yeah. Okay. Yeah. Is depression also a fair target for R-MDMA? Yeah, I mean, I think it would be given the characteristics that I described around some of the psychedelic-like characteristics, and, you know, we had a healthy population. There were certainly some movements on these things, but they were healthy, right? So, it could very well be a reasonable indication. Got it. There's quite a few things that opened up. Now, I want to caveat it appropriately that it was a small phase I trial. Yep. Right? So we need to get some replication on a larger study on the behavioral effects that we saw. Moving on to a non-psychedelic compound, RL-007. I just wanted to say RL-007. Yeah. No, of course. What do you expect to see in that phase IIb data set in mid-2025, and what would success look like? Because cognitive impairment associated with schizophrenia is an extremely tough indication. Yeah, agreed. And that was one of the reasons that we went after it, right? A huge unmet medical need. Companies have gone after it. There have been some phase IIs, there's been some phase II successes along the way, including with Boehringer Ingelheim's compound. But yes, generally, it's been a very challenging indication. So, you know, we're not—y ou know, success here is, you know, a little bit more modest, I guess. I mean, with the psychedelic, we're expecting relatively large effect sizes. Given the nature of this indication, we are looking even for small changes that, because they can be very meaningful for these patients, right? So the way to think about these drugs, realistically, is you'd likely use them in the context of some kind of behavioral therapy, occupational therapy, et cetera. And the idea is that it kind of allows, it opens up the patient to a little bit more receptivity to such therapy, such that over time, you can really change the course of their life, and that's the goal here, right? Got it. So, you saw some results from the Boehringer study, in terms of T-scores, in terms of what the—y ou know, where they netted out on the same endpoint that we're using, the MCCB. You know, obviously, something around those lines would be, would be fantastic. Yep. Are there any other portions of your pipeline that you'd like to highlight before we move on to some other general questions? No, I think we talked about most of it. I mean, obviously, BPL-003, we touched on as well. So yeah, that, that's coming up. Now I'll move on to some financial strategy, big picture type things. You have a stake in COMPASS. I do. I think it's 15.4% or something like that, at least. It's a little less than that. A little less than that now. Yeah. That's right. Um, yep. Yeah. What are your plans for that stake, and how would you approach that, given what might happen with COMPASS later this year or early next with their data set? Yeah. I mean, I would say that it's mainly a strategic or financial stake at this point. We were obviously very close to COMPASS for a long time. When we were both private, I was on the board. Florian was also on the Co-CEO, was also on the board, so heavily involved in a lot of their activities. Obviously, they went public before we did. That changed things. I fell off the board at that point, and then, as we were—y ou know, we've both been public for a while, there's very much a clear firewall there. They've also had subsequent rounds of equity raises, and that's pushed our stake in the company lower. Now, as a general statement, of course, you know, we always assess our position in the company, depending on results, et cetera. We, a few years ago, obviously made a decision to increase our stake based on the phase IIb data. But, you know, again, we'll reassess as data comes in. Got it. This is a question I sometimes get from investors. You know, investors like to see an end game sometimes, right? Yeah. So with atai, you are a collection of assets. You have so many in the mental health space. They're all very non-traditional type assets for the most part. You have data on those, and you've kind of de-risked them when you get into the clinic. But what is the end game for atai? Is it wanting to be a commercial organization by yourselves, doing everything like a traditional biopharma company would? Or would you get these products to a point and then let someone else fly with them? Yeah. I mean, I think we have optionality, on that point. So the story. You know, we were more complex earlier, at earlier times, right? So we did have more of. We had more companies under the umbrella. We had a more diverse set of, you know, business models or, you know, relationships with those companies. We have simplified that pretty significantly. So we have these, you know, we have EMP-01. We have VLS-01, the EMP-01. We didn't talk about the ibogaine that's going into a phase, a new registration, going into phase I. And then we have this stake in BPL or Beckley. So we have simplified things pretty significantly. Now, going back to the, you know, the question around commercialization, RL-007, we've always said— RL-007, another one, a GABA asset, we've always said that probably that's something that we would try and transact once we have proof of concept data. Yeah. That stands because phase III is going to be very large there. Right. Commercialization is really outside of the purview of a small company, realistically. Now, with the psychedelic assets, it is a tractable commercial problem, so we could go down that road if we chose to. So what I mean by that is J&J has done a fantastic job of establishing a number of clinical sites. I mean, that's how they're gonna be a blockbuster this year, right? Over $1 billion. They have about 4,500 clinics, give or take, that are administering a compound, their SPRAVATO, at this point. That's what we want to use. That's an infrastructure that we want to leverage. 4,500 sites, again, is tractable. That's a relatively small sales force that one could put, that one could put together. We have multiple assets that are kind of staged, that would all use that same infrastructure, so there is a compelling argument that one could have. Of course, we're not stupid, and if, you know, someone comes knocking on our door, then, you know, that's a different story. I mean, there, there are other companies, larger pharma companies, have expressed interest, right? Because J&J is doing quite well with this. Yeah. There are logistical challenges with SPRAVATO. You have to be in the clinic 12 times in 8 weeks. Sure. That's not great, right? So, there are other parties that are interested. I'm curious to see how things go with COMPASS as they start reporting out their two phase III trials, as they move towards NDA. We'll see how that, that plays out. Right. Yeah, so it's an evolving space. Very interesting. Yeah, absolutely. Thanks for making the time here, and we'll look out for catalysts. Sounds great. Thank you.