Thank you for standing by. My name is Carly, and I will be your conference operator today. At this time, I would like to welcome everyone to the Atai BPL-003 Phase 2B data conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question-and-answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. Thank you. I would now like to turn the call over to Ashley Barretto, Head of Investor Relations at Atai Life Sciences. Please go ahead. Thank you, Operator, and good morning, everyone. Joining me on the call today are Dr. Srinivas Rao, Chief Executive Officer and Co-founder of Atai; Cosmo Fielding Mellen, Chief Executive Officer and Co-founder of Beckley Psytech; Dr. Robert Conley, Chief Scientific and Medical Officer of Beckley Psytech; and Dr. Kevin Craig, Chief Medical Officer of Atai. Before we begin, I would like to remind everyone that this call will contain forward-looking statements, which are subject to risk and uncertainties. Any statements regarding future events, results, or expectations are forward-looking statements. Please note that these forward-looking statements reflect your opinions only as of the date of this call. We undertake no obligation to revise or update these forward-looking statements in light of new information or future events, except as required by law. Information concerning factors that could cause actual results to differ materially from those contained in or implied by such forward-looking statements are discussed in greater detail in our recently filed 10-K, available on our website or on sec.gov. I'd now like to turn the call over to the host, Dr. Srinivas. Srini, over to you. Thank you, Ashley, and I want to take this opportunity to welcome everybody to this call. We are thrilled to announce the results of the Phase 2B trial of BPL-003 in treatment-resistant depression. The trial, in summary, exceeded all our expectations, and we're going to have the team kind of walk you through that data. 1st, I'm going to hand it off to to give you kind of a quick overview of the results. Cosmo? Thanks, Srini. This is very exciting for me personally and for the company, but also, I believe, for patients in need. As you mentioned, the Phase 2B of BPL-003 has met its primary and 2ndary endpoints, demonstrating the single dose of BPL-003 induces a rapid, robust, and durable antidepressant effect. This means, as you said, we've met the success criteria, and we're moving forward to the next stage of the strategic combination. What BPL-003 has shown for the 1st time, really, in a large, properly controlled study with a long-blinded follow-up, is that a short-timing clinic with a psychedelic with a short psychedelic effect can show really durable antidepressant effects. With both the 8-mg and the 12 mg doses, we saw highly statistically significant and clinically meaningful reductions on the MADRS scores compared to the active comparator 0.3. That was at all time points. From the day after dosing all the way out to two months of blinded follow-up, we showed that a single dose had this really robust antidepressant effect. That is really, really exciting for patients. In addition to that, the drug was generally well tolerated at all dose levels. There were no serious drug-related adverse events. 99% of the adverse events were mild or moderate. Importantly, there were no suicide-related safety signals in the treatment arms. This Phase 2B data puts us in a really strong position to move forward into Phase 3 rapidly. We believe the 8-mg dose is a really great dose to take in as our lead dose into Phase 3. With the sites that we've got in the U.S., Europe, and Australia, they are currently finishing up the open-label extension where we all look at a 2nd dose and the effect of a 2nd dose for people eight weeks after that 1st dose. They are also ready to start Phase 3 as soon as possible. We really think we can move this very quickly into the next Phase of development. Overall, again, what was really encouraging is that BPL-003 was shown to require a very short time in clinic. This single dose administration with a two-hour in-clinic treatment time really fits into the paradigm that's been established by Spravato and sets us apart from other psychedelics in the space, as well as setting us apart from Spravato because what we've shown is a single dose has comparable or even superior efficacy to Spravato after eight doses at one month. We are really excited about that. To go into more detail, I'll pass over to Rob. Thanks very much, Cosmo. I'm excited to share our study overview and the top-line results of our study today. Next slide, please. Depression remains a very serious mental illness and a life-changing condition that affects millions of people in the U.S. and around the world. It is the 2nd leading cause of disability worldwide. About a third of the cases of depression are considered to be poorly responsive, treatment-resistant. We are addressing a major mental health need and really a public health need with this development program. Next slide, please. This study is a worldwide study. It was done under an IND with the FDA. Half the sites were in the U.S. With what I'm about to show you, the positive results of this study, as Cosmo had said earlier, we're ready to have an end-of-Phase 2 meeting as we develop our data and move into Phase 3 rapidly. This is the 1st and only, to this point, large controlled clinical study with mebufotenin. We think it's going to be very critical for development in this field. Next slide, please. This is the overall study design. The people who went into this study had treatment-resistant depression. That means in a single episode of depression, they had failed at least two different trials of oral SSRI antidepressant medication. A lot of people were on medication, about 2/3. Those people were washed out of their drug. This was monotherapy in this study after washout and qualification. People were randomized to take either 12 mgs, 8-mgs, or 0.3 mgs of our study drug. The 0.3 mgs was chosen as a dose that we looked at mebufotenin in our 1st trials, our Phase 1 trials, and knew that this was not a dose that produced a psychedelic effect, but there were some physical and physiologic effects that mimic the higher doses. The FDA really was very interested at the time we designed this study to have a super low dose as a masking condition to help with the blinding of the study. We chose that. As we go into the future, we will very much likely, in fact, almost certainly, be doing placebo-controlled studies. What I'm going to show to you today is the core of the study, which is an eight-week blinded period of observation. In our overall study design, after that eight-week blinded period, people had an optional redosing. That'll be in our later data reports of what happened with that. There is a redosing in the overall study design, but what you're going to see right now is the effects of just one dose of mebufotenin. Next slide. This again, just to emphasize that the core that I'll show today is this eight-week blinded period. During this time, our primary outcome measure was the MADRS score, which is a well-known depression rating score. Most of my data will relate to that. We've done a number of other looks at how depressed people were, how they were adapting to their life. We'll be showing that in future dates. Today, we'll focus on our top-line data of MADRS outcomes. In this study also, patients received psychological support. That meant that before they got the drug, they were oriented to what was going to happen to them. During the drug administration period, there were two people in the room. That was an FDA mandate. These people were not doing psychotherapy. They were really coached. We looked at the audio tapes from the room to make sure that people were not really doing any psychotherapy. They were there to help a person if they were anxious or upset. They could give PRN medication if it was needed for anxiety. That was never needed during the study time, during the time of administration. Afterwards, people were allowed to check in two or three times with a Zoom call to make sure they were integrating back into their life. This is not a study of psychotherapy. This is a study of a drug effect. Next slide, please. I'm going to show you the top-line data right now. Next. 1st is our demographics. Not to belabor it, the most important thing is that the three arms of the study, 0.3 mgs, 8-mgs, and 12 mgs, were well-balanced. The same type of people went into each arm. Again, these people were moderately to severely ill with their depression. They tended to be ill for more than two years and had failed, again, at least two drugs within their depression episodes. These were very ill and very persistently ill people. Next slide. Now I'd like to show you the outcome of this study from our single-dose design. What you see here is what we think is very good news. If you look at the top gray line, that is the outcome of that low-dose study, the low-dose arm that I told you about. Here you do see a little bit of change. This is very similar to, for example, what we see in the Spravato label, where they looked at similar dosing over time, but they actually had to give the dose eight times over the 1st month. This is data from our single dose. You do see a little bit of fall in that arm. That's expected. The drug arms, on the other hand, show rapid separation. Day two, there's already significant separation in both the 8 and 12-mg arm. By day eight, we have pretty much a complete drug effect, it looks like, with both 8 and 12 showing a marked separation from the pseudoplacebo. Day 29, which is our primary endpoint, we actually have a 12-point fall in that 8-mg arm. That does persist out to day 57. Statistically, these lines are flat, so they really do look like we have an effect that begins at day eight and goes out for two months. This is the core of what we've discovered, really, is 1st off, the drug effect seems to persist. If you get better, you seem to stay well on this agent. The other one that we were really trying to look at here is what's the best dose. We thought 8 and 12 might likely be good doses from our earlier preclinical and clinical data. What we saw here is something we hoped for but didn't necessarily expect, was that 8 looked as good as 12. In general, giving a lower dose with better efficacy or the same efficacy is a good thing. Lower doses tend to have fewer side effects. You'll see that more as we show that, that we're happy to see the efficacy that we saw in the 8-mg arm. Next slide, please. Another way we looked at things is with predefined responder and remission rates. To be a responder, you had to at least lose 50% of your MADRS score over the course of the study. That means if you went in with a MADRS score of 40, it had to be 20 or below to hit responder. I'm saying that because it's important to know that if you're not a responder, it doesn't mean you're a non-responder. We had many partial responders in this study, which we'll report more on later. At this high level of response rate, you see again the similar effect that by day eight, about a third of our subjects are hitting this response criterion. They stay that way. They have here their responder at day eight. You tend to be a responder through day 57. The people in these groups tend to be the same people over time. The response seems to be very resilient on this agent. Another way of defining these things is remission. Remission is even a higher bar. Here you have to have a MADRS score of 10 or less. That level has been seen clinically as a score that means basically you do not meet depression criteria anymore. The people are beginning to really enter into what you would think of as a recovery Phase. By day eight, a quarter of our subjects on the 8 mg arm hit that level. That stays that way through the two months. Now you do see somewhat of a difference between 8 and 12 mgs, a little bit less on 12. We're not sure why that is right now. We do think it's not so much a U-shaped curve or anything like that, but it's more likely that we've hit an efficacy plateau that 8 is literally as good as 12. And often, as you go up on dose but don't go up on efficacy, you may lose a little bit of effect because of side effects or other things. We're looking at this more. But we think the overall sum from the line graph I showed you before and what we see here right now is that, in a sense, 8 is enough, that we really have hit a good efficacy dose that we can take forward into our future studies. Next slide. I'd like to show you a bit about the side effects. Here, there are treatment-emergent side effects within the study. As you see, 1st, the 0.3 mg is not without side effects. About a third of our subjects did report some. We did expect, as I mentioned, that there might be some physiologic effects with this. We think that helps with masking or blinding. That is what we've seen. There are obviously more side effects on the active drug arms, 8 and 12 mgs. What you see here is that 8 looks a little better than 12. It's not without side effects, but it does appear to be a little better than 12. Importantly, 99% of our treatment-emergent events were mild or moderate. There were no drug-related serious adverse events. The majority of our treatment-emergent events resolved on the day of dosing. Actually, 70-some percent did. Blood pressure and heart rate were some areas of special interest we looked into. Serotonergic agents in general are known to cause blood pressure changes. We looked at that very carefully within the study. Importantly, while we found a slight increase in blood pressure and heart rate, they resolved within an hour. We did not hit the level of serious adverse events or needed treatment intervention for that time. In essence, the drug was able to clear that cardiovascular hurdle and looks very safe in that regard. Also, we looked at dischargeability. This study was at least four hours in length. No one went home, as it were, early on. We asked our investigators to rate whether or not a person could go home beginning at 90 minutes. This is different than what you'll see from some other sponsors because able to go home means the psychedelic event is over with, the person is psychologically clear, they're neurologically and medically clear. It is a thorough criterion. We developed a rating instrument with the FDA to test this out. The majority of our patients, in fact, over 70%, were rated as able to be discharged at the 90-minute window the 1st time we looked. Over half of the ones that didn't make it at 90 minutes made it at 120. There were some that were longer than that. This drug is really meeting the criterion that the very large majority of people can literally go home from the clinic, we think, within two hours. We'll test that more as we move into Phase 3, but we think this critical criteria is being met. The next slide. Another thing of special interest is suicide-related safety signals. Here, fortunately, we got a negative signal. There were very low rates of treatment-emergent suicidal ideation. A quarter of the people who went into the study have suicidal ideation. This is, unfortunately, very much part and parcel of the depression experience. No one could have an active intent or behavior and be randomized in the study. This is something that's more of a chronic condition. Here, we found some subjects still had that problem as they went into the study. It was rated as potentially a drug-emergent-related suicidal event. It was not new in anybody. This was in people who had it before. Also, importantly, as a person beginning to have intent or behavior, in other words, are they suicidal? We did not find that at all in any of the drug arms. We passed through that criterion too. It appears that there's a negative signal here. We're very glad to see that level of safety with the drug. Next slide. In the study, 90% of the participants completed the whole study. There was only one drug administration, so they did not have to take any extra drug. They were able to complete all the ratings and did everything they were supposed to to finish up the two-month follow-up period. That's critical for our analysis plan. If you have too high of a dropout rate, it's hard to know that your data is valid. We had set up our statistical plan to assume we might have as high as a 15% dropout rate. Only having a 10% really allowed us to feel very secure that our analysis plan was good, met, and we can really trust the data that we're showing you. Of those people who completed the study, they then were eligible to potentially take another dose in the open study. And 85% of the eligible participants did want to roll over into the open-label study. This did not mean that they were in relapse. This meant that the clinician and the patient thought they maybe could benefit from another dose. This is very exploratory to understand how often one should redose and how the redoses will look. We will be able to report that data later. In our Phase 3 studies, we will be looking at much more criterion-based redosing to understand how often the drug has to be given. This will give us some data to help us develop our Phase 3 plan. Next, I'd like to sum things up. Our key achievements now are that what I've just shown you is that buprenorphine in our study has shown a rapid, robust, and durable therapeutic benefit. It seems to last for at least two months. Responders remain responders. Good tolerability profile, very acceptable data. We're glad to have the negative suicide finding. We do see that two hours in the treatment clinic time seems to fit into our model, which is critical. We do feel that we've now found good support for advancing 8-mgs into our Phase 3. Very soon, we'll have new data points to consider as in our development program. You'll see on the right-hand side that our top-line data from our open-label extension study, which I had mentioned to you, showing the safety, efficacy, and durability of the 2nd dose. We hope to have them in the third quarter of this year. Our top-line data from another Phase 2 open-label study, which is looking at a different induction model. It's giving the drug twice over the course of a couple of weeks. One dose and then two weeks later, another dose. That's being done right now to make sure we have the best efficacy marker. Important to know with the current study that we have right now, the single-dose induction model, if that replicates, we do have an approvable product. We want to make sure we're giving as much benefit to people as we can. We're studying this to help us inform our Phase 3 plan. Finally, we intend to file an end-of-Phase 2 meeting request with the FDA in the third quarter of 2025. Those are some upcoming looks over the horizon of what we'll be doing. Next, I'd like to turn things back over to Srinivas to help us move forward and sum things up. Thank you, Rob, for that detailed review. Now, let's talk a little bit about BPL as it relates to competitors, specifically Spravato. Next slide, please. Now, let's talk a little bit more about Spravato, which has been a game changer for the treatment-resistant depression space, as it's the 1st approved drug that utilizes the interventional psychiatry paradigm, which we'll talk about a little bit more in a 2nd. Spravato, last year, did achieve blockbuster status. About $930 million of that was achieved in the United States. Interestingly enough, there's about 5,000 clinics that are certified to deliver Spravato. They treated about 40,000-50,000 patients, to the best of our understanding, in 2024. This is out of a total of 3 million patients with treatment-resistant depression. Really a very small drop in the bucket. The interventional psychiatry paradigm that Spravato uses is as follows. Essentially, the patient comes in, is administered a single dose of Spravato. They're then monitored for at least two hours afterwards. They're allowed to be discharged. While each individual visit is fairly straightforward, as I described, there are just many administrations that have to occur over the course of a year. The 1st four weeks involve two administrations per week, so a total of eight administrations. Weeks five through eight actually involve once-a-week administration. Then subsequent to that, in the maintenance Phase, administration is every two weeks or less. However, we have learned that many subjects do, in fact, get dosed on a weekly basis. Next slide, please. Interestingly enough, BPL-003 and BLS-01 were both designed from the outset to fit into this two-hour paradigm. This was obviously work that was done several years ago. The anticipation was that the marketing might of J&J would ultimately prevail here. Of course, as we just talked about, that was, in fact, the case. Atai Beckley is in a unique position now as the company with the only assets that are designed to fit into this two-hour paradigm, with single administration, two hours of follow-up, and then potential discharge thereafter. These two assets are, of course, BPL-003 and BLS-01. Everything else is either longer duration, still a Sybin, MDMA, LSD, etc., or involves a more complex paradigm, like a multi-dose administration of 5-MeO-DMT. Again, we view the two-hour paradigm as really important for commercial scalability. Next slide, please. Of note, the efficacy that we are seeing with BPL-003 is actually very similar to what was observed with Spravato in their monotherapy trial. That is shown on the slide. The MADRS curves are there on the left-hand side. The two data points at the top or the two curves at the top are the placebo responses, and those at the bottom are the active drug responses. While there is a little bit of difference or divergence in the 1st dosing or the 1st dosing day, you see that the two curves basically coalesce over time. By the time you get out to four weeks, the efficacy that's seen with both of these, placebo versus drug, is almost indistinguishable. What's important to note, however, is that to achieve that efficacy with Spravato, it took eight administrations, each two hours long, each obviously requiring transport to and from the doctor's office. With BPL, this degree of efficacy was achieved with a single administration. Rob had walked you through both the remission and responder data. You can see on the right-hand side that essentially both of these data, both BPL and Spravato, look pretty much the same, again, certainly by the time you get out to the four-week time point. All right. Let's go to the next slide, please. This is kind of a quick overview of the differences between Spravato and BPL-003. Again, both are delivered in this, well, we certainly anticipate BPL-003 being delivered in an interventional psychiatry paradigm. They both require a degree of predose education and counseling. There's also some follow-up from a safety perspective afterwards. We've talked a lot about the two-hour treatment paradigm, the two-hour window for discharge. Again, the big difference here, BPL-003, we anticipate an induction paradigm that consists of only one or two doses versus the eight doses and up to 12 doses, in fact, with Spravato over the course of eight weeks. That durability is really the key here with BPL-003. That two-month durability certainly suggests that going forward, maintenance could consist of a dose given every two to three months. And that's certainly something that we're building towards. Next slide, please. All right. Now, let's talk a little bit more about next steps. Next slide, please. In summary, Atai and Beckley are better together as Atai Beckley. We have this focused pipeline of rapid-acting, short-duration therapies for mental health. We have an experienced management team, again, a combination of both Atai and Beckley. We have a fully owned pipeline with 1st-in-class potential. This is a major change from Atai from previous years. We have many near-term milestones. These include some of the data that are forthcoming around BPL-003 itself, but also large Phase 2B readout from BLS-01 and a Phase 2A readout from EMP-01, all of which will be in the 1st quarter of next year. We have talked a little bit about the commercial scalability of our products, particularly BLS-01 and BPL-003. We have a very strong IP portfolio. Finally, there are long-term financial synergies, obviously, by bringing these two companies together. Next slide, please. I'm not going to go into this in a lot of detail because this is a bit of a rehash from a presentation a couple of weeks ago. As I mentioned, these data were critical for a critical gate for moving forward with the strategic combination of Atai Beckley. Just to reiterate, this is an all-stock transaction. The non-Atai Beckley shareholders in Beckley Psytech will receive 105 million new shares. That's about 31% of the pro forma. The combined company will be led by me. As I mentioned, the executive team will be a combination of Atai and Beckley management. The transaction is expected to close later this year, subject to shareholder approval. Next slide, please. I'm very happy to share this combined and simplified pipeline, which consists of BPL-003 as the lead. This is the furthest along, obviously. As we've discussed, we're going to be prepping to bring this forward in the Phase 3. BLS-01 in a Phase 2B trial currently. Again, as I mentioned, readout in the 1st quarter of next year. EMP-01 is a very interesting asset, very differentiated. It's R-MDMA, very unique properties were observed in the Phase 1. We're looking at this in a different indication than most other people are currently investigating, which is social anxiety disorder, Phase 2A readout in Q1 of 2026. Of course, we do have a range of interesting early-stage assets, discovery-stage assets, including non-hallucinogenic compounds, reputatively non-hallucinogenic compounds. Next slide, please. All right. In summary, and as discussed, I mean, obviously, in the Phase 2B trial, BPL-003 demonstrated robust efficacy acutely. Equally importantly, it demonstrated that a single administration resulted in statistically significant durability out to eight weeks. That's a very important point. Drug was very well tolerated, and suicide-related safety signals were absent. We also confirmed the short-duration nature of BPL-003, with the vast majority of patients being discharge-ready by two hours. Finally, as mentioned, BPL-003 has a strong IP position, with issued US patents covering both composition of matter on the salt as well as on the formulation. Next slide, please. With that, I'd like to open it up to questions. I'll hand it off to the operator. Atai, I would like to remind everyone, in order to ask a question, press star, then the number one on your telephone keypad. We'll pause for just a moment to compile the Q&A roster. Your 1st question comes from Andrew Tsai with Jefferies. Hey, Srinivas, Cosmo, and team, congratulations on the robust data set. Thanks for taking my questions. With this data set and this kind of durability that you're seeing out to week eight, what do you think is ultimately going to be the redosing paradigm? Is your mind still set at two months and then redose? Or could it look like, hypothetically speaking, something like three to six months? I ask because presumably fewer doses per year has positive implications to price and commercial sales and convenience and all that. Thank you. Thank you, Andrew. I really appreciate the kind words regarding the data. Of course, we're very excited about these data as well as the fundraise today. To answer your question, obviously, these data go out to eight weeks. One of the things that we're exploring going forward is really two-dose induction. Two-dose induction could potentially get more subjects into remission. We anticipate the durability being more or less the same. We'll obviously explore a little bit further in subsequent trials to take it out to 12 weeks. We anticipate right now some kind of a redosing in sort of the two to three-month window. Of course, that's still subject to change. We have some additional analyses that are forthcoming. That's kind of where we're at currently. Of course, as you point out, that's a huge, huge improvement over the standard of care with Spravato, which, again, right now is about once every two weeks per label, two weeks or less per label, but does tend to be dosed as frequently as once a week in many subjects. Makes sense. In addition to, as we think about news flow over the coming months, can we expect you to seek a breakthrough designation sometime this year? If so, how confident do you think you would get one with this Phase 2 data set? Yeah. I mean, we haven't gone into the details of our regulatory interactions. Of course, we'll announce as things come up. Obviously, we think this is kind of a game changer for the space, so something that we'll take a look at. Okay. Very good. Thank you. Congrats. Thanks. Your next question comes from Ritu Barretto with TD Cowen. Good morning, guys. Congrats, everyone, on this data. 1 question on efficacy and then a couple on safety and tolerability. Guys, if you look at the responder and remission rates on slide 13, do you have the consistency rate, I guess, between patients on their day 29 and day 57 remission and responder? Or do you have a rough estimate as to the overlap of those patients that remitted or responded between those dates? Okay. Actually, I'm going to hand that off to Rob. I think you're just talking about sustained response, more or less. Yep. Yeah. Okay. Yeah. Yeah. Hi. Thanks for your question. Yes, we are looking into that right now. We will have those precise numbers pretty soon. In general, we are seeing the same people who respond at day eight continue to respond out through day 57. Yeah, the responders and remitters seem to be very resilient. They move into that category and stay there. The retreatment in the open label, will it be the same dose as what patients were randomized into in the controlled Phase? I'm just wondering what sort of investigation may be done if 8-mgs is the right dose for everyone. If there may be data in your clinical trial looking at patients who either didn't remit or maybe even didn't respond at 8 and how they may respond at 12 mg at some point. Is there any other question? Oh, yeah. Absolutely. Yeah. Would you like me to take that for you? Yes, Rob. Go for it. Yeah. Sorry. Yeah. Yes, that's a good question. We really were dose exploring in this study. For our retreatment Phase right now, we have used 12 mgs. That's what we had guessed as the high dose, and we wanted to test that dose in the study. However, we are going to look at retreatment with 8 and with others. You make a good point that if you do not respond at 1 dose level, do you respond at another? We'll be looking at that, but I doubt it. I actually think that probably 8 is going to be the response dose. As Srini mentioned, it may be that an increased initiation dose frequency, giving two doses a couple of weeks apart, might be a bit better than just the 1 dose. That data is to come. Right now, the vast majority of the people who got the open retreatment were getting 12. We'll probably be changing that in the future, obviously, to see if an 8 redosing will be adequate. Given our acute data, I think it will be. Understood. And then just moving on to tolerability, I've gotten just a few questions from clients on the administration site pain and discomfort. Can you speak to that a little bit? And then can you tell us what the longest sort of discharge period was? We're looking for sort of the outside error bars for a patient in this study to basically be discharge-ready. Thanks. Sure. 2 different answers there. 1st, for the administration site pain and discomfort, we lumped a couple of things together in this one. Basically, it was a feeling of nasal fullness or irritation. It usually lasted a very short period of time, 15 minutes around that time. That was basically resolving into the psychedelic experience. In other words, when this nasal puff was given, people feel it. It honestly might be a little bit uncomfortable. It was not intolerable. Nobody was upset by it, or they had to continue on because the nasal puff had gone on. It was not a clinically unmanageable situation. When the psychedelic experience occurs, basically, people did not talk about the nasal experience anymore. At the end of the day, pretty much it was then resolved. That was what was up with nasal discomfort. It was not a terrible pain. You had a 2nd part to your question? Yeah. The sort of outside bound of. Oh, the outside bounds for the dischargeability. Yeah. We have worked with the FDA to develop a discharge readiness questionnaire. And we're still working on that is the answer. What we found is that 70-some% of the people, the 1st time they were checked at 90 minutes, were discharge-ready. That meant that they both had a clearance of their psychological or psychedelic effects, neurologically clear, cardiovascular clear. They were literally ready to go home. About another half of those, so getting up to about 85%, were clear the next time they were checked at 120 minutes. We had a few more at 150. That was basically the grouping. In this questionnaire, we had a question where some of our investigators were being very conservative. They checked off 240 minutes. In their notes, they noted that people were clear, but they knew the protocol lasted for four hours. They said, "Oh, you're not ready into it. Your protocol is done." We'll look at the FDA with that question. For us, the outlying number was 240. Then literally, everyone went home at that point. It wasn't as if they were waiting to clear. In other words, we have all these ratings that they're clear, their metabolic status was okay, their cardiovascular status was okay. They were just waiting because of the protocol. I think it's going to be around 150 minutes. Also remember, this is one where, kind of like in the Spravato label, you don't have to have everyone wait until the outliers make it, as it were. You can clear someone as soon as they're ready to go home. With Spravato, they have to wait for two hours. Then they can check people, and people can go home. Here, we hope that most people will go home after 90 minutes. Some will be a little bit longer than that. Right now, I would say the outlier number, I think, we're at 150. It might be a little bit longer than that. We'll work with the FDA to improve this interview so we don't have the investigator confusion. Understood. Thank you. Thanks, Ritu. Your next question comes from Pete Stavropulos with Cantor Fitzgerald. Hi, Srinivas, Cosmo, and team. Congratulations on these data. Thank you for taking our questions. The 8-mg and the 12 mg doses, they seem to perform similarly in terms of responder rates, at least the 1st 57 days. There seems to be some differences in remission rate. Was there any meaningful differences in the duration of the active period, meaning perceptual changes between the two arms, or any differences in the depth of perceptual changes? Was the average time they were ready for discharge the same? Yeah. That's a great question. The bottom line is that the differences between the two doses were pretty marginal. I'm going to let Kevin take that in a little bit more detail. Yeah. Thanks, Srinivas. Yeah. Too, I think completely back up Srinivas. The differences between the 8 and the 12 in terms of discharge readiness were very similar. We need no differences there. In terms of the depth of the experience, again, broadly overlapping. Remember that we selected these doses to be overlapping in terms of PK and in terms of psychedelic experience, the 12 being slightly higher. The body of the distributions were broadly overlapping. When we looked at the MEQ scores, very little difference between the 8 and the 12. All right. Thank you. Now two questions for the OLLE. You have the 12 mg dose once the subjects roll over. Can you help us understand why you chose to do it at a fixed time point rather than being triggered by an additional administration based on predefined criteria, such as a particular score on the MADRS? What are you hoping to learn by this? All right. Kevin? Yeah. Sure. I think there are a couple of ways. Of course, without the data, the core data to hand, it may be quite difficult to make that decision. I mean, we're particularly interested both in the efficacy of the 2nd dose and on the safety and tolerability, the theory being that perhaps a previous psychedelic dose may improve things in terms of safety and tolerability, taking time around, less anxiety, etc. The way that the program was constructed was that there was a choice, both patient choice and investigator choice. Patients could decide that they are in remission and do not want another dose. We did not have fast criteria on having to have a certain MADRS score. I think we were kind of interested in the group that were sort of responders, whether we could drive further response and drove other people into remission. Clearly, I think as we go forward, we'll think about how that redosing strategy should look. That was the thinking behind the OLLE. All right.One last question. Generally speaking, oh, go ahead. Sorry. No. Go ahead, Srinivas. Sorry. I was just going to add one comment. I mean, you don't want to make the redosing criteria too stringent or too complex as a general statement. How often MADRS is really used in clinical practice is open to debate. So having more in terms of both patient and physician judgment and input, I think, is going to be a little bit cleaner going forward. I mean, obviously, all these things are going to end up in the label. This is something that we're very cognizant of. Okay. And 1 last question, if you don't mind. Again, for the OLLE, it's 12 mg dose. I guess some participants are going to get 4 mgs and 8-mgs approximately 10 minutes apart. What's the rationale for the biphasic dosing and expectations? Hey, Rob, you want to take that one? Yeah. Thanks. We were exploring a number of different dosing paradigms when we 1st designed these studies, which was about three years ago. At that point, we really did not know what was going to be the most tolerable and the safest way to give it. The rationale for the 4 and 8 was if there was a lot of nasal problems or some other side effect problems when it was being 1st initiated at 12, that 4 plus 8 would be better. We have not seen that, honestly. We have actually seen that the single dose works very well. It is tolerable. We do not really need to do that splitting. I do not think we are going to do any more of this dose splitting in the future. I am not sure of that. We have not made all of our final decisions. That is why we were doing it. We were exploring the most tolerable regime. You will see a couple of different paradigms there that we looked at to gather the data to make the choices we are going to make now to go forward, which will very likely be with a single administration. As we have said, with 8, any 1 time, it will just be the one puff with very likely the 8-mgs. All right. Thank you for taking our questions. Congratulations once again. Thank you. Thank you. Your next question comes from Sumant Kulkarni with Canaccord Genuity. Good morning. It's great to see these results and potential options opening up for patients. Thanks for taking our questions. I have three quick ones. 1st, what are your latest thoughts on intranasal dosing versus inhaled dosing? Is there any reason to believe that difference might lead to differential efficacy or safety? That's the 1st. I mean, so we've obviously spent some time thinking about this one. The challenge with inhaled, of course, or pulmonary delivery is that the pharmacokinetics can be very different. We've shared the pharmacokinetics with BPL-003 and, of course, VLS-01 for that matter. We have Tmax's, the time to get the peak concentration is sort of in the 10-20 minute range. Obviously, a concordant rate of rise, which I think is good for mitigating side effects, etc. Inhaled, obviously, gives you a very rapid PK. There's at least some data that you can either out there that that can lead to additional adverse events in terms of flashbacks and things of that nature. We had basically nothing in our trial, two subjects, actually. It was really sleep-related. I think we're firm believers in this route of administration and the PK that arises from it. Obviously, it does result in a somewhat longer psychedelic effect. But we view this as a feature and not a bug. We have this two-hour window. We do want to try and maximize that so the patients have an opportunity to get the maximum benefit during that period of time. I mean, big picture, we are obviously very, we think that, very bullish on this. There are other concerns with pulmonary. I have worked with pulmonary delivery in the past. The FDA has always had some challenges with that and always put some roadblocks up in terms of safety, etc. Lots of toxicology studies, etc., in a previous life and clinical monitoring. Again, let's see how that all plays out. Got it. The 2nd one is, given there are so many data points that can be released over time, psychedelic therapeutics appear to be eminently suitable to utilize this newly contemplated National Review Voucher Program for potential approval within 1 to 2 months of filing. Do you expect this pathway to be eventually viable for your filing? Are you planning to discuss this during your end-of-Phase two meeting, or will that meeting be purely related to Phase three design? That's a really great question. We have a number of touchpoints with the agency coming up, obviously. It's something that we'll be exploring without a doubt. There's somewhat limited details available on this pathway at this moment. We have been very focused on getting these data out there, cleaned up and out to the public. It's absolutely something that we're going to be exploring. Got it. The last one. Srinivas. Yeah. Sorry. It's Cosmo here. I just wanted to come in quickly on the inhaled versus intranasal. One other point that I think is worth highlighting here is that from a commercial perspective, intranasal is very, very similar to what Spravato has already established as the successful paradigm. We are using an Aptar device as per Spravato. The 5,000 clinics trained on Spravato, the change from that to BPL-003 is going to be extremely minimal. It's a single administration with an Aptar nasal device. I think that gives us a very significant commercial advantage over other routes of administration aside from the DMT. Got it. That's a really important point. Last one. As investors, we sometimes need to put the cart before the horse. Given you have these data now, what are your initial thoughts on a pricing paradigm? Will this type of therapeutic be priced annually regardless of number of doses in a year? Obviously, we're having those discussions internally. We'll provide some guidance as we get closer to launch. I think what we can broadly say is that all the companies in this space are sort of anchoring in one way or another to the pricing of Spravato. I think that's true in a sort of a big-picture sense. The details of that in terms of price per dose and how that corresponds to the number of doses over the course of a year, that's something that will obviously take some additional data to really support. Thank you. Your next question comes from Patrick Trucio with H.C. Wainwright. Patrick? Patrick? Patrick, your line is open. Hi. Sorry about that. Good morning. Congrats on the data. Just the 1st question I had is I was wondering if you had observed any delayed responders in either the 8 or 12 mg arms, patients who responded only after day 8 or day 29. 2ndly, as it relates to the OLLE study and the two-dose induction cohort, would you expect to have this data prior to the end-of-Phase two meeting with the FDA? Would you need to have this data in order to initiate the Phase three trial? Irrespective of initiation, I mean, we do anticipate all of these data relatively soon and certainly in line with the end-of-Phase 2 meeting. I'll take that bit. I'll let Rob take the 1st question. Yeah, that's a good question about the response pattern. What we've seen so far in looking at our curves is it looks like the vast majority of patients really do respond in that trajectory that you see with the mean line, meaning that they're a bit better the 2nd day and then almost fully responsive at day 8. We're very much looking for delayed responders. Now, again, our responder definition was that 50% or greater improvement. So remember, those are pretty robust response of people. Once we look better at the partial responders, 30% and 40% improvers, maybe we'll see that more delayed response. There's a very active data set. We're still looking at that. Yes, we will look to see if there's delayed responders. Yes, we'll see if there's a way to treat them. Don't have that for you yet. We're doing that analysis now. Great. And then, Patrick. Yeah. Sorry. Again, being real, I'm butting in here again. It's Cosmo. Just going back to your 1st question, I think one thing that we are very pleased about with the Phase two program in totality is that beyond this core part where it's characterizing a single dose, we will have data on patients on SSRIs. So we've already published that data, which is really encouraging for our Phase three. Also, we will have two-dose data both as an induction and as a maintenance model. If you think how other companies, for instance, Compass, who've done brilliant work, they didn't have that data moving into Phase three. They were still able to set up a Phase three with a two-dose induction paradigm. They didn't have data ahead of that to show what that might do, whereas we will. I think that's a very useful position for us to be in. That's a great point. Yeah. That's interesting. This question around functional blinding has come up. As discussed in the past, I think that this is something that's sort of common throughout neuropsychiatry. I'm just wondering, how is the program designed to sort of mitigate that impact? How do you see, especially as we now move into Phase three, what are some things that you can do to mitigate that impact or just sort of, as we look ahead to a potential advisory committee, address those concerns? Yeah. I think it's important to highlight functional blinding and what that term actually means, right? As you point out, functional blinding in the CNS space is pretty common, right? My example is always something like fluoxetine and paroxetine. If I give you those two drugs in a clinical study, you're going to pretty much know which compound you're on very quickly. That's really nothing new. The agency is pretty comfortable with that. Of course, dose ranging is pretty key there in the context of these acute or intermittent therapies. Getting durability data is really critical. I think that can be mitigated. There's a clear path for that that's already been established. The functional blinding that tripped up Lycos was a little bit different. I mean, there were elements of what I just talked about. They didn't have dose ranging. Also importantly, they had essentially staff and therapists on blinding, right? That is a bit different. That was unusual. That was new to the agency. What I mean by those therapists on blinding is that you had a therapist that was with the patient prior to the dosing, during the dosing, and then after. That person obviously has a pretty good sense of what that patient was on. The problem there is that they can then adapt their therapy based on what the patient got. That was one of the concerns there. In terms of the current study, I mean, again, we saw a good placebo response in this trial, right? We want to see a placebo response. That speaks to the fact that patients were, in fact, blinded and did not have a very good sense necessarily of what compound they were on. I'll let Rob kind of handle the question about how many of the folks actually felt that they were on compound. Going forward, I think there's, again, sort of the key things going to Phase three are, again, making sure we have some additional dose ranging data, which is something that we're exploring. The agency has backed away a little bit from the sub-perceptual or sub-psychedelic dose approach in terms of that, which was a 0.3. They're more inclined for sponsors to use placebo. That's something that we're going to be looking into as well. Rob, I mean, I don't know if you have any follow-up to that. Yeah. That's a good answer, Srinivas. I'll just add a little bit to that. I would say one thing that's, or two things that are very important. One is our team, the treating team, meaning the administration team, provided some support to the patient. They weren't providing psychotherapy. They were not their primary psychiatry clinic. That was separate. We never took that over. Our raters, people talk about centralized rating. That means a person who's not connected at all with the study team, essentially through a video conference, does the rating. Importantly for us, one thing we found that actually worked that was a bit of a technical challenge, where we got it to work, is that the raters didn't even know what study visit the person was in. It could have been two days after administration. It could have been 57 days after administration. They were just doing this interview to see where they were at. Part of what really happens with blinding is what do the patients think, but also what do the raters think? We had raters who really were blinded to what was going on with the patients. They were not their patients. They were just rating them. They did not know what day, what treatment day it was. In other words, the raters did not. I think that all contributed to this and made us think we can present what is a truthfully blinded study to both subject and raters. Great. Congrats again. Thank you so much. Thank you. Thank you. Next question comes from Beatrice Fairburn with Varenberg. Hi. Thank you very much for taking the questions. I have two, if I may. My 1st question was on whether you could highlight any differences in the trial that you think are important compared with the Phase 2B from your competitor GH Research and explain how these may be important as we interpret the data. My 2nd question really was asking if you were seeing increasing interest from large pharma regarding partnering or M&A. Thank you. There's my two. Yeah. Maybe I'll start on that 1st one and then hand it off to Kevin. Fundamentally, the trial that we conducted is a pretty standard study for psychedelics. It is really in the mold of what Compass pioneered for their trial, right? This is a study that looked very similar. Indeed, most of the psychedelic trials that are out there look pretty similar. It is a dose or two doses. It is some blinded period and a primary endpoint that is somewhere in the four- to six-, maybe eight-week range, and then some extended period of blinded follow-up beyond that. More than one dose. That really kind of addresses some of the concerns that we've talked about already. This is a pretty typical trial. This is something the agency has responded well to already and will respond well to. Again, it's important to emphasize this trial was done under IND, as is also the VLS-01 study, I should also mention. I think the study that was conducted by GH, I mean, one of the things that made interpretation somewhat difficult, of course, is the eight-day blinded period only. You don't have an opportunity to really determine what the rate of decay is, etc., because it went straight into open-label dosing afterwards. There have been some challenges with the IND insofar as it's intensive with the subjects in terms of interaction with the staff. That led to a great deal of unblinding, or so it seems, right? They didn't know placebo responses was reported in that trial. Even adverse events, there were almost none in the placebo arm. Obviously, most of it was in the drug arm. I think there were a couple of things that made interpretation of that study more challenging. Again, it's an unusual, it's just an unusual design. Kevin, I don't know if you have anything, or Cosmo as well. I don't know if you have anything to add. Yeah. Thanks, Rudy. I mean, I think you hit the right points. I mean, I think the patient population was a bit different as well. Their baseline MADRS was a little lower in the GH study. And their duration of illness was significantly shorter. We had about two and a half years of depression in a current episode versus GH, which was about 13 months or just over a year. I think this is maybe a more treatment-responsive group as well. In the GH case, we had a more difficult-to-treat group in our study. I think the blinding and the duration of follow-up, I think, is important. I think we feel like we've got a trial that is broadly predictive of outcomes in Phase three because it looks a lot like trial design that we're going to run in Phase three. I think that's, from my perspective, something that counts in our favor. Can I add maybe a quick question? Yeah. Yeah. Thanks, Srinivas. I mean, clearly, as you said, a big difference is the dosing model. So we have a single administration, which can fit into two-hour in-clinic time. And it's a single model intranasal like Spravato. The individualized dosing regime with GH 001 is you have one dose of 6 mgs. Then you wait an hour. If you don't have a peak experience, you have a 2nd dose of a higher dose at 12 mgs. You wait an hour. If you don't have a big enough peak experience, you have a third dose of an 18-mg dose. You can have up to 36 mgs in a single session and three doses. Obviously, that's a much longer period of time that you're sat in the clinic as well. If you just look at the absolute MADRS drop, at day eight, they had a 15-point MADRS drop. With our 8-mg dose, at day 29, we had a 12-point MADRS drop. I think there's a very comparable level of efficacy. Obviously, we've shown a longer durability with the blinded follow-up. I think those are really, really important differences. Again, to come back to the point of kind of in terms of commercial viability, we have a device that has previously been approved by the FDA. It's very, very similar to what Spravato used, whereas an inhaled kind of volcano vaporizer or a proprietary vaporizer that's going to be planned for Phase three, I believe, is not something that has gone through that process before and is not something that Spravato clinics will be familiar with. I think those are some really, really important advantages as well. Yeah. I think that's where we separate. Clear. Thank you. My 2nd question. I'm sorry. Could you repeat the 2nd question? Yeah, of course. My 2nd question was really just asking if you're seeing any increasing interest from large pharma regarding partnering or M&A. Yeah. Absolutely. I think a lot of this has really stemmed from the fact that Spravato did, in fact, hit blockbuster status. I think there is a greater appreciation of the interventional psychiatry paradigm at this point and its viability. The fact that J&J, which is not prone to exaggeration, we will put it that way, is guiding over $3 billion or $3 billion by 2028, I believe, is also helping things. Yeah, absolutely. There has been a lot more interest over the course of the last, I do not know, six months or so. I mean, it has definitely been a bit of a change from what we saw before. Okay. Thank you. Of course. Your next question comes from Elmer Piros with Lucid Capital Markets. Yes. Good morning. What I'd like to ask is if there was any difference between the discontinuation rates between the 8 and the 12-mg arms, please? Of course. Hey, Kevin, do you want to take that one? Yes. I could just repeat that question again. Yeah. No, that's fine. I didn't hear it, so I broke up a bit. Yes. The discontinuation rates between if there was a difference between the 8 and the 12-mg arms, please. Very good. Yes. I think, I mean, the 1st thing to say is that we didn't have any discontinuations for adverse events. These were mostly lost to follow-up or withdrawal of consent, which I think is important. There was a slight preponderance of discontinuation in the 0.3-mg arm, which again is not surprising, but no real difference between the 8 and the 12. Okay. Okay. Also, if you wouldn't mind comparing the baseline characteristics or duration of illness in this current study versus the open-label trial that you conducted, if there was any, because there is a difference, absolute difference in the MADRS response. I was wondering if that comparison is fair. I'll let Kevin handle the details there. I do want to note that in general, when it's a blinded study, there will be differences in the response rates, right, because the patient doesn't know what drug they're going to get, what their intervention actually will be. It doesn't surprise me. In fact, I view that as a positive that there's a difference in the open-label data versus the blinded data. Kevin, feel free to add to that and also answer the balance of that question. Yeah. Sure. So I mean, I think, as you say, I mean, we know from the data that we've presented that the baseline on average is going to have dropped. Now, clearly, there will be people coming in on the 0.3-mg arm that will be dropping, potentially dropping further than those who are emitters coming through the core study. I mean, that is valid. I think we're more interested, I suppose, in the incremental effect in all patients as to whatever their baseline is at entry to the open label, where does it go from there? We sort of expect a differential response. Those that are coming in slightly higher, say, they're coming out of the 0.3-mg group, are expected to drop lower. We haven't, of course, got that open-label baseline data yet. I think that's a certain just knowing what's coming out of the core and what's going into the open label, we would expect, 1stly, differences by dose arm. Even, again, those that sort of, as Rob was talking about, those partial responders of 30%, what happens to those groups when they get a 2nd dose after eight weeks? Yes. Yes. Did I hear you correctly, Srinivas, that you're contemplating an intermediate dose or a dose between placebo and now the 8-mg dose in a pivotal trial? It's something that we're exploring, but obviously, haven't come to any conclusions. We have additional data sets that will be coming, additional analyses that will be coming in because what we're reporting now is just the top line. There will be some more stuff that comes in over subsequent weeks. Once we have that data in hand, obviously, we'll make a case to the agency and then align with them in terms of what that Phase three trial looks like and in terms of what doses we would have to include. Yes. You make a valid point that the key difference between the GH study and yours is that you included US patients. Was there a difference between US and ex-US outcomes? Patient outcomes? No. We did that analysis. It's not by country at this point, but it is U.S. versus ex-U.S. The responses are broadly the same. Yeah. Sorry about this silly housekeeping question, but at what price did you the offering was priced at? Good question. That was at close markets yesterday. It was $2.19, two point one nine cents. Thank you. Thank you very much. Thanks and congratulations. Of course. Thank you very much. Your final question comes from Simone Kulkarni with Canaccord Genuity. Thanks for this follow-up, which comes more from a nice-to-be-in-this-position perspective. Given we now have a couple of Phase two data sets in favor of the 5-MeO-DMT molecule in treatment-resistant depression, how are you thinking about prioritizing BPL-003 versus your VLS-01 DMT program, either financially or strategically? Yeah. So I mean, that's come up a couple of times. I mean, I would just view these as different products that have different properties, right? The molecule itself is quite different. Some of the subjective effects that we saw, we being both Atai and Beckley across respective Phase one trials, was a bit different, even though the PK was very similar. I think these are going to be different assets. Of course, we are going to run the Phase two beta completion, the one with VLS-01. We have opportunities there. I mean, TRD is a huge space. I mean, it's certainly well within the realms of possibility that we could develop both for TRD. The blockbuster status of Spravato was based, as far as we can tell, on approximately 50,000 patients, as I mentioned in the webinar itself. That's out of a total of 3 million patients. It's a huge total addressable market, and we certainly have options there. We're also looking at different subsets, right? I mean, there's anxious depression, etc., that one could certainly contemplate. There's MDD as well. So there's a few things that we're looking at here, and then we'll make some decisions once those data come in. Understood. Thanks. There are no further questions at this time. I will now turn the call back over to Dr. Srinivas for any closing remarks. 1st of all, thank you for all the great questions. I mean, obviously, this has been an incredible six months for Atai. It's been very transformative. We've obviously raised about $140 million so far. We've got continued support from our founder and chairman, Christian. We're also thrilled to have the backing and support and vote of confidence from Fair Inventors and some of the new funds that have come in over the course of these three raises. Obviously, these data are truly exciting and groundbreaking. We have met all the success criteria that were previously outlined for the strategic combination, the merger with Beckley. Looking forward to advancing that into the shareholder vote stage, which will be later this year and, again, closing sometime in the latter half of this year. Yeah, again, looking forward to presenting some additional data for the BPL-003 program over the course of the next several months in different formats, getting that end-of-Phase 2 meeting request in, and indeed getting this Phase 3 program going. As we've talked about sort of obliquely, we have VLS-01. Its Phase 2 data, Phase 2B, is going to be coming out in the 1st quarter of next year. We have a Phase 2A with EMP-01 in a different indication, which is social anxiety disorder. Very exciting year to look forward to as well. With that, I'm going to close. Again, thanks to everyone for their attention and great questions. Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.