Thank you for standing by. My name is Kate, and I will be your conference operator today. At this time, I would like to welcome everyone to atai Life Sciences and Beckley Psytech conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a Q&A 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. I would now like to turn the call over to Ashleigh Barreto, Head of Investor Relations at atai Life Sciences. Please go ahead. Thank you, Operator, and good morning, everyone. Before we begin, I'd like to remind everyone that this call will contain forward-looking statements, which are subject to risks and uncertainties. Any statements regarding future events, results, or expectations are forward-looking statements. Please note that these forward-looking statements reflect our 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 a recently filed 10-K available on our website or at sec.gov. I'd like to now turn the call over to the host for today, our Co-Founder and CEO, Dr. Srinivas Rao. Srini, over to you. Thank you, Ashleigh, and thanks to everybody in attendance. We are really excited today to announce the business combination between atai Life Sciences and Beckley Psytech. We believe this combination is going to be very synergistic and unlock a lot of value for both patients and shareholders. Before stepping into some of the details, I do want to hand it over to Cosmo to give a little bit of context around Beckley and his views on the combination as well. Cosmo? Thanks so much, Srini. Hi, everyone. Yeah, this is a very, very exciting time for me personally and for Beckley Psytech. The backstory of Beckley is that it was co-founded by my mother and I. My mother, Amanda Feilding, sadly passed away very recently, and she had devoted her entire life to the scientific research of psychedelics, how they work in the brain, and how they can be used to help patients in need. Beckley Psytech was the latest chapter in that mission, and the aim was to really take the next step of developing these compounds into approved, licensed, and accessible pharmaceutical medicines for patients with mental health conditions. We've been doing that since 2019. We're about to read out a large phase IIb, and if that goes well, we think this is the perfect time to join forces with atai Life Sciences for the kind of later-stage development as a combined company. We've already been working together with atai for about a year and a half. They were early backers and shared our vision. We know each other already, and we're very excited to take the next step. I'll pass back over to Srini. Thank you, Cosmo. As you can tell, we're really excited about this combination, Atai Beckley. The resulting company is going to have a really focused pipeline of differentiated psychedelic products. We have a management team that's incredibly experienced. This is a wholly owned pipeline, which is a major point of differentiation from atai and Compass Pathways. Many near-term milestones are important inflection points for the company, a strong IP portfolio, and the consolidated company is in a much better position to raise funds for subsequent clinical development. Let's go to the next slide. This is a quick summary of the deal terms. I'm not going to go into this in a ton of detail, but the important points to note are that this is an all-stock transaction. Essentially, the non-Atai Beckley shareholders will receive 105 million shares of atai newly issued shares. That's approximately 34% of the pro forma company. I'll be leading the combined company, and the executive team will consist of members from both atai and Beckley. The deal is subject to close based upon some pre-established or pre-negotiated success criteria around this upcoming phase IIb trial. We do anticipate the transaction to close in the second half of this year, subject, of course, to standard approvals. Go to the next slide. Here is the combined management team. I mentioned that I'll continue as CEO of the company. Cosmo will be coming on board as Chief Strategy Officer, and Rob Conley will be joining as Chief Research and Development Officer. Between the folks on the screen, there are literally many decades of experience in publicly traded drug development companies across many different therapeutic areas, certainly a lot of experience in psychiatry and indeed psychedelics more recently. Really excited to be working hand in hand with all of these folks on this slide. Go to the next slide. This is the pipeline of the combined company. Again, really differentiated psychedelic products across different areas of incredible unmet medical needs. We have BPL-003, EMP-01. We're talking about that in a lot more detail, both in treatment-resistant depression, EMP-01, which is our oral formulation of R-MDMA in social anxiety disorder. Finally, we do have a discovery pipeline as well that we look to bring forward, including non-hallucinogenic compounds, I should mention, that we look to bring forward in the clinic in the next couple of years. Go to the next slide. As I mentioned, it's going to be a very busy year for atai. We've got many upcoming milestones. The one that we're going to be talking the most about today, of course, is the BPL-003 phase IIb, and that's the results of which are forthcoming. Rob will give a little bit more color on the trial itself and what we can expect from that. VLS-01, we recently discussed that recently announced initiation and paid first patient dose, top-line results first quarter of next year. Exactly the same for EMP-01, top-line at the beginning of next year. Finally, RL-007 is being developed for cognitive impairment and schizophrenia, clearly a non-psychedelic compound, very different than the others. We are anticipating top-line results from a large phase IIb in the middle of this year. Go to the next slide. Okay, let's talk a little bit about the market opportunity. Again, this is all of the psychedelic compounds that I mentioned are utilizing an interventional psychiatry paradigm. This is essentially for individuals with more treatment refractory conditions, be it depression, social anxiety disorder, or generalized anxiety disorder. The patient comes into the clinic, is administered something, or has some intervention performed upon them. This is done on an intermittent basis. Traditionally, this has been things like rTMS. More recently, it's been ketamine. Of course, we can let's go to the next slide. We can talk a little bit about Spravato, which is the first pharmacotherapy that was approved as part of the interventional psychiatry paradigm for treatment-resistant depression. The important things to note here is that despite a slow start, Spravato did achieve blockbuster status last year. $930 million of that was actually from the United States, and that was based on approximately 50,000 patients and a relatively small commercial sales force. Spravato is administered under a REMS program, and there are approximately 5,000 clinics in the United States that are certified to deliver Spravato. This is the exact commercial footprint that we wish that we'll be looking to utilize when both BPL-003 and VLS-01 are launched. There is good efficacy with Spravato. The challenge with Spravato is the frequency of administration. It is complicated to administer in the sense that there are just many, many visits to the doctor's office. This is an induction and maintenance paradigm per label. Induction takes eight weeks, and it is 12 administrations during those eight weeks. After that, maintenance is once a week to every two weeks, the minimum amount that is needed to keep the patient in remission. Some people have mentioned this is almost like a second job. It approximately can be up to almost three weeks out of your life per year being dedicated to getting this kind of a therapy. There is lots of room for improvement on Spravato. Let's go to the next slide. All right, I mentioned broadly that psychedelics do seem to have more durable efficacy compared to ketamine and esketamine. That has certainly been evidenced with psilocybin, but also more recently with LSD as an example. Instead of efficacy that lasts days or most of a week to two weeks, like you see with ketamine, with esketamine and ketamine, here you can see efficacy that can go up many months, indeed almost up to a year in some cases. Okay, let's go to the next slide here, and let's talk a little bit about the BPL-003 and VLS-01. Again, these are short-duration compounds. The idea is to fit into the same paradigm that's been established by Spravato. We'll talk a little bit more about that on the next slide. The compounds and these products themselves are differentiated. BPL-003 is nebuprenorphine, and VLS-01 is DMT or dimethyltryptamine. Both have the potential to be both first-in-class and best-in-class for their respective compounds. Pharmacologically differentiated, 5-HT1A focus for nebuprenorphine, much more of a 5-HT2A focus for dimethyltryptamine. Both are transmucosal, so there's some overlap there, but different route. BPL-003 is intranasal. It's a dry powder. Intranasal, of course, is very much like Spravato. VLS-01 is transmucosal, but with a thin film. It's basically a Listerine strip. Again, two-hour duration. Broadly, we have very good patent coverage for both assets in the United States. We have both composition of matter, and we have methods of treatments that are issued, and we are obviously pursuing additional coverage. Let's go to the next slide. Again, we've talked about Spravato in the two-hour paradigm. BPL-003 and VLS-01 are right there with it. All of the other compounds that are in development are either much longer per administration or involve a more complex paradigm. Multiple doses in a given day, for example, with another product that's also utilizing 5-MeO-DMT or, for example, LSD, where the psychedelic effects can last 8/ 10/ 12 hours. This is simplified. It makes it easy for patients. It simplifies things for doctors as well. It's a paradigm that both groups are familiar with. Okay, let's go to the next slide. All right, let's do a deeper dive into BPL-003. With that, I'm going to actually hand it off to Rob to take you through it. Thank you, Srini. Hello, everyone. I'm very happy to be a part of our new combined effort and really looking forward to our work together. Please show the next slide. What you're going to see here is the results from our phase I work, which was done in normal controls, who had never been exposed before to psychedelic medication. We thought this was important because there have been concerns with psychedelic medication that they might be hard to tolerate. We wanted to test this out in many ways in the most vulnerable population possible, a group of people who were not experienced with psychedelics. What you see here, the top curve is the blood levels. It looks at the blood level of BPL-003 going up and down over time. You see there's good dose proportionality, but importantly, the medication is cleared from the body within 60 minutes to 90 minutes. The bottom slide, you see every two minutes we checked on the psychedelic effect with people asking them how they were feeling and where they were on a psychedelic scale. You see that also going up and down really very much matched to the blood level. Here it's what we really do think. What Srini was talking about a lot in the earlier slides, that this short time in the clinic is very important. We feel very confident that this is going to happen with this agent as we move forward into studies because we're showing it here from the beginning with normal controls. Also, we use psychedelic naive people because we were concerned that people might not tolerate the medication well. We wanted to test that. Turned out they did. There were some side effects, mostly things like nasal irritation, but those tended to clear right away during the psychedelic episode. Importantly, about 90% of the people who had taken this agent in the phase 1 study when asked were willing to take it again. We asked everybody, and about 90% said they definitely would. The next slide, please. That phase I data allowed us to move into a series of phase IIa studies. These are unblinded studies, but we looked at treatment-resistant people, people who had failed two drugs in the clinic while they were depressed and were remaining depressed. Our first study was with a single dose of BPL-003 monotherapy. We did this because that's kind of the safety issue whenever you're doing a new agent. You want to make sure people are only on that agent and not other confounding medications. People were followed over time. I'll show you this data in just a minute. We've completed that data set. The second study we did was people who, again, were poorly responsive to depression, but they were on SSRIs. So they were on an antidepressant. They didn't have to stop. There have been concerns that being on SSRIs might mitigate the psychedelic effect and lead to less efficacy. There also have been safety concerns that maybe it would be less safe, particularly in a cardiovascular perspective. What I can tell you, what we found in this, and I'll show you efficacy in a moment, is from a safety standpoint, we're very fortunate. We did not have any serious adverse events or adverse events that were more than what we saw with monotherapy. This agent was well tolerated. We sort of answered that safety hurdle. We're also doing a third study of two administrations of BPL-003. We're doing this because we want to make sure we have exactly the right clinical administration profile as we plan our move into phase III and thought this would be very important data to collect. You'll see the safety and efficacy in just a moment here now. Let me have the next slide, please. This is from that first study. These people, this is monotherapy. People were not on any background SSRI medication, but they all had treatment-resistant depression, failing two drugs while they were depressed and remaining depressed. What you see here is after this single administration of BPL-003 that within a day, their MADRS scores, which is a method of clinically detecting depression level, went down quite a bit and stayed down. You see the line looking flat over the course of 85 days. We followed people up for actually almost three months in this study. Also, we a priori defined responders and remitters. A responder had to lose at least 50% of their pre-existing MADRS score, and a remitter had a MADRS score that fell below 10, which is clinically recognized as a score equivalent with not being depressed. Really kind of a complete remission from depression. Importantly here, you see that about half of the subjects met this responder criteria, which is losing 50% is a high bar of response. Importantly, they stayed down over the course of the three months. The same people who responded stayed responsive. Remission, even this higher bar, again, occurred quickly and stayed over the three-month follow-up period. This medication in the open study seemed to not only work quickly, but last quite a while over the three-month follow-up. Patients were considered ready for discharge within a couple of hours after administration of the medication. That followed along with what we expected to see in our phase I data. Again, overall, the medication was well tolerated. I'll show you more of the side effects later. Next slide. This is the second study where patients were on SSRI medication. They were on antidepressants, were not responding to them, but they were allowed to stay on their medications. Again, they were given one dose of BPL-003. You see again that there was a rapid fall in the mean overall MADRS score. It went down to almost 10, and it stayed that way over the course of the three-month follow-up period. You also see now with the predetermined response and remission criteria that we had a very high level of response and remission. Again, it persisted over time. We had no new safety signals detected with SSRIs. We had that clean safety profile. We had a very high level of response. I will caution you to not compare things too much just yet because these are small open studies. We'll know more as we go in time. Importantly, as we prepare to work with the FDA and other regulatory agencies to move into phase III, we're hoping this allows us to have the choice of moving into adjunct therapy as well as monotherapy, which will give the drug its best chance in the clinic to reach the most number of people that could be helped. We think that's very important. There are no tolerability and really no safety changes that would prevent that. Efficacy, at least in this open study, looks quite good. The next slide. This is the side effect profile. In this, we see that people, now this is from all of our phase I or all of our part 1 and part 2 safety studies in phase IIa, forgive me, in our open phase II studies. There is some administration site discomfort that typically is a fullness or some irritability or pain in the nose. That typically resolves within the psychedelic experience itself. Some nausea and vomiting. For these, we did look at this pretty carefully. What we found is that we did not have people who had a very serious emesis, meaning gastric contents coming up. It was more something that could be called very serious hypersalivation or some uncomfortness. That also tended to resolve very clearly within the episode. Other events mostly were resolving on the first day. You can see that 97% of the events were considered mild or moderate. There were no serious adverse events. 90% of the events, as I was mentioning earlier, did actually resolve during the day of dosing. Most were really resolving on their own. All actually resolved without intervention. We did not have to treat any of these other than care and watchful waiting. The AE profile of this drug in treatment-resistant patients is similar to what we have seen in healthy volunteers. The subjects we are asking in these studies would be willing to take this as a treatment again. Over 90% were very willing to take it as a treatment again. From both our phase I and phase II studies, we feel that we found a drug that does have this short effect in the clinic, is efficacious, seems to persist over time, and importantly, is tolerable to people. They're willing to experience this even if they would need retreatment in the future. Next slide. This is that phase IIb study that I was alluding to. This is a blinded study. It is 12 mg, one administration, again, importantly, 8 mg versus 0.3 mg. This is a so-called pseudoplacebo dose. We studied in phase 1 the clinical effect of 0.3 mg, and essentially there is none. There is no psychedelic effect. It does mirror some of the side effects of the other doses. In many ways, it is thought to be a nice masking condition. True placebo is important too. We will probably move to things like that within our phase III study. In this study, in order to have a good masking condition, we decided to go with the ultra-low dose, this 0.3 mg. Here, after the single administration, this is monotherapy. Again, for safety reasons, we did not have all that SSRI data when we first designed and started this study. We followed people for now two months in a blinded fashion. After two months, they were allowed an optional next dose if they and their clinicians wanted them to have that. What we will see soon is how well do people respond on MADRS scores. Does the score stay down over the course of two months? Does it statistically beat the low-dose design? We may see dose ranging between 8 mg-12 mg. That's why we have the lower dose of 8 mg in there to be able to try to detect that. Also to be able to see some other life-changing events, like can people return to work or other things. You can follow that up better as you follow people for a couple of months. We'll have some much longer-term data in people as the people who are redosed or followed for two more months after their redosing. Now, that's an open redosing, so that won't be blinded. The blinded study will give us pretty good data for both acute efficacy as well as persistence, which we think is very important. Next slide. All right. Next, we do have a very strong IP position with our compound. To describe that for you, I'm going to turn things back over to Cosmo. Thanks, Rob. A quick overview. Mubifosinine itself is a naturally occurring compound. We have focused our IP strategy on BPL-003, our proprietary formulation of mubifosinine benzoate. What we've shown is it has superior properties to other salt forms and the free base in terms of higher permeation, less irritation, greater stability, and dose-proportional pK. These are novel and non-obvious advantages that have allowed us to build a strong IP portfolio that extends out to 2043 already. That includes multiple composition of matter patents as well as methods of use patents and methods of synthesis patents. They have been granted in the U.S., Europe, U.K., and beyond. We have many additional patents pending, so we expect to be able to extend that patent term beyond 2043 in the coming years. In addition to that, we expect to have regulatory exclusivity provide additional protections upon approval of BPL-003. Next slide. To summarize, I'm going to hand over to Srini. Thank you, Rob. Thank you, Cosmo. Fundamentally, we think that both Atai and Beckley are much stronger together than separately. We have this opportunity to create some really important, impactful psychedelic treatments for a range of unmet medical needs in mental health. We have products that we are the leader. Between BPL-003 and VLS-01, we are the leader in short treatment time or short-duration compounds. We have patent protections that are quite robust across the portfolio. The compounds are both first-in-class and best-in-class for their respective drug classes, nebufetine for BPL-003 and DMT for VLS-01. We talked extensively about the BPL-003 phase IIb readout, which is forthcoming. We have, as I mentioned, multiple phase II readouts over the course of the next 12 months. Finally, we think that the combination, a single public entity, fully unlocks the value of both the atai and Beckley Psytech assets. With that, I'm going to open things up to questions. At this time, I would like to remind everyone, in order to ask a question, please press star, then the number one on your telephone keypad. We will pause for just a moment to compile the Q&A roster. Our first question comes from the line of Andrew Tsai with Jefferies. Your line is open. Hi, good morning. Congrats on this merger. Cosmo, again, my condolences about your mother. Nonetheless, thanks for taking my question. It's exciting to see this news. My question is around the threshold for success in this upcoming phase IIb data for the deal to close. Is the threshold higher than what you've powered for the primary endpoint? Does that success criteria also include no new safety signals as part of that agreement? Thank you. Hey there, Andrew. Thank you for the kind words. The success criteria are outlined in our filing. I mean, fundamentally, it's Statsig on the primary, and there's some other criteria around safety, particularly around SAEs. I mean, they would address the concern that you outlined vis-à-vis powering. I don't know if Rob or Cosmo, if you have anything to add to that. I can jump in real quickly. We did power the study in a manner to show statistical significance with a good separation that's very similar to other antidepressants and psychedelic antidepressants. To my knowledge, I'm pretty sure this is true, actually, that there's no difference in the terms of deal. It's not a higher bar. It's the same bar that we'd already set and powered for. Perfect. Thank you. Your next question comes from the line of Ritu Baral with TD Cowen. Your line is open. Hi, guys. This is Athena On for Ritu Baral. Subject to the closing of this transaction, how should we think about the prioritization of your pipeline following the 003 data readout, upon which you have BPL-003 and EMP-01? Are you thinking of licensing other products or any other business kind of strategic opportunities moving forward? Thank you. Thanks, Athena. I think what we can say is that we've got plenty to chew on between the four assets that we've got moving through the clinic at this point. Obviously, BPL-003 is the lead at this point. Then we've got the BPL as a pretty rapid follower just behind it, currently for the same indication. I personally am a little reticent to say one way or another regarding other business development. But again, as I said, we've got plenty going on at the moment. Recognify, of course, is their RL-007 readout is also forthcoming and sort of on top of the BPL readout. There may be some sort of transaction on that. We'll see once we get the results in hand. Thank you. I do actually have another follow-up question. Have you had any FDA interactions recently, and how were the cadence of those interactions given movement in the agency? Thank you. We don't normally go into details on FDA or regulatory interactions, but yes, the answer is yes. We have had multiple interactions. Specifically, I can say around BPL-003 and so far, so good. I mean, generally speaking, the cadence and the responses have been very, have been not surprising. We've had good response from the folks at the agency. No deviations at this point to note. I know that's not been true across all companies, but so far, so good for us. I don't know, Rob or Cosmo, if there's anything else that you want to add vis-à-vis BPL. Yeah, I think on our side. Yeah, go ahead, Cosmo. Yeah, exactly. No, exactly. I mean, the big one that we'll be preparing for is subject to the phase IIb data that we'll read out soon. We'll be preparing for the end of phase II meeting with the FDA. We already have an IND in place, which is important to note. This study is being conducted in the U.S. as well as other countries. We believe if the data is good, we have a very clear path forward into phase III, but that will be subject to the end of phase II meeting and other meetings beyond. Got it. Thank you. Your next question comes from the line of Sumant Kulkarni with Canaccord Genuity. Your line is open. Good morning. Thanks for taking our questions, Cosmo. Our condolences to you and your family on your mother's passing. At the same time, it is really nice to see all the work done translating into what could be bigger and better things for patients. I have a couple of questions. First, how quickly did administration site discomfort resolve post-dosing of BPL-003? And is that an important real-world variable? Cosmo, maybe I will let you answer the first bit around your family. Then maybe, Rob, you could jump in on the site reactions. Yeah. No, thank you very much for mentioning my mother. It's a sad time for the family, but it was a beautiful ending to a wonderful life. She was very excited about this transaction. She was asking about it till the very last day. It is good news for her too. Just quickly on the site administration pain, and Rob will be able to talk in more detail. This is something that is completely standard for any intranasal formulation. It's short-lasting. There is no kind of damage or anything like that. It's been checked. It is literally just a kind of intranasal administration. I would say that the important thing is that we've had really good patient acceptability up to this point. In the phase I and the phase IIa studies where we've asked patients whether they'd be willing to do this treatment again, we've had very high percentages of people saying they would be able to do it again. The tolerability and the patient acceptability looks very good so far. Thanks. The follow-up, either in phase III or in real-world practice, would this involve one or more doses of BPL-003 during the same treatment? Given what you know as of now, how are you thinking about the redosing paradigm? Just big picture on this. I mean, we have always emphasized this Spravato paradigm, and that is typically just at least one dose. I mean, it's a single dose in time, right? You just administer the compound, and you do not do any sort of redosing. That is what we anticipate for both of these, right? There may be—you may put it in both nostrils. That is a different issue, but really a single dose for each visit. Just to keep things simple, there is no additional checking in with the patient. There is no additional redosing at some point, like say an hour later or 45 minutes later. Keep it simple is what we are really focusing on here. Got it. Thank you. Your next question comes from the line of Patrick Trucchio with H.C. Wainwright. Your line is open. Thanks. Good morning. And Cosmo, condolences to you. And just team, I have a couple of follow-up questions. I guess the first is just how will—assuming BPL-003 is brought in, how will you distinguish this program relative to the VLS-01 program? How will these two compounds kind of fit into the pipeline? Are there different patients and different populations that each may be relevant in? And then separately, regarding BPL-003, how should we think about this next phase IIb readout just relative to the other short-acting psychedelics in clinical development? How comparable are these programs from one to another, the phase IIb trials from one to another? How should we think about the next steps from here? The pivotal phase III program, what will that look like? Additional details there would be great. Thanks, Patrick. I think you've just hit upon the very definition of a first-world problem. Let's see how these two proceed. I mean, as I've mentioned in the slides and we've discussed one-on-one, there are some pretty significant differences between these two products. The compounds themselves are different. They're pharmacologically differentiated. Certainly, if you look at anecdotal reports, there are marked differences in the subjective experiences between 5-MeO-DMT and DMT. In our respective phase Is, there have been some differences that were noted. Of course, those are small studies, and we'll look to the phase II results first. I do want to mention that, as I said in the slide presentation, the blockbuster status of Spravato is based on approximately 50,000 patients in the United States. That's out of 3 million patients with treatment-resistant depression. We believe that there's certainly space for more than one of these in treatment-resistant depression itself. I will also say that psychedelics in general are relatively—they're kind of agnostic to the diagnosis in a sense. They impact these underlying pathways that are dysfunctional in a range of psychiatric indications. There's certainly opportunity to expand or differentiate based on indication if that's the decision that we choose to make once we see all the results. I think that's really going to be the key here. I think that also is fundamental to some of your other questions. I mean, we certainly haven't guided on anything regarding phase III at this point, and it's going to be heavily dependent on getting the data from both phase IIs, quite frankly. Again, I will open it to Rob or Cosmo to add anything or any additional color to that. Thanks, Srini. I mean, I completely agree with what you're saying. I think we will see as data comes out how the different short-acting psychedelics differentiate and how some may be more appropriate for certain subpopulations than others. In terms of other short-duration psychedelic studies, I think one could highlight that our phase IIb with BPL-003 is a large kind of dose-ranging study. It's looking at a single dose, and it's blinded for two months. The aim there is to really properly characterize what a single dose of BPL-003 does in this patient population and really look at the durability. We will have additional data on a second dose after eight weeks as well. The real focus is on that first administration with a very simple treatment model in place. We think having dose-ranging and an active placebo are both very important parts of the study. The FDA certainly liked that. We think it should give us a good, clear path towards phase III. We think we are very much on track to be first to market with a short-duration psychedelic. Thanks. Your next question comes from the line of Harry Gillis at Berenberg. Your line is open. Hi. Thank you very much for taking the questions. I'd also like to share my condolences to Cosmo and also congratulations to all on what looks like to be a great deal. I appreciate you can't talk in too much detail now, and we don't want to get ahead of ourselves regarding the phase III trial design. As we do think of that, I'm just thinking whether you plan to maybe run one trial with an active placebo and one with a true placebo. Is that sort of the current guidance you're getting from the FDA? Also, how quickly do you think you could launch phase III trials provided the phase IIb is positive? Just as we approach the phase IIb readout, could you perhaps highlight any differences that you think are important compared with the phase IIb from your competitor, GH Research, and how that may be important as we interpret the data? Thank you. Yeah. Let me start with that last point on GH. If you kind of think about big picture, there's a couple of really key points around functional blinding of the patient. That has come up in different contexts that even predate psychedelics. Really looking at durability of response is kind of key here. Looking at those responses is also important. In the context, as Cosmo just said, the phase IIb that we'll be reading out very soon addresses both of those points squarely, right? There's two doses versus the subperceptual dose. We have a chance to compare these two doses. Indeed, there's eight weeks of blinded follow-up. I think these are the major points of differentiation from GH Research. GH Research had only eight days of blinded data. They did not have dose-ranging. Just because of the intensity of the paradigm with lots of interaction between the provider and the patient during the day of administration, there was a lot of unblinding, which is evidenced by the fact that there was really no placebo response. I think there are a lot of differences between these two trials. I think big picture, if you look broadly across all of the psychedelics, all of the trials in phase III look pretty similar, right? Be that LSD with MindMed or Compass, of course, or Cybin, Usona. Every one of these trials looks pretty similar. It's like one or two administrations and an extended blinded follow-up, typically in the sort of 8 week-12 week—typically 12 weeks, I believe, if not longer in the phase III. How the FDA will view the short-duration paradigm, the short-end point paradigm that GH is using, is currently unclear. They may get lucky with that one. I mean, I think the only company that really tried that was Sage. Of course, that did not work out, but did not work out for other reasons. We will have to see how that all plays out. Going back to the placebo point just for a second, the subperceptual dose was something that had been discussed and, of course, was pioneered by Compass. At least some of the feedback that we are hearing at this point is that the FDA is less concerned about that. In terms of having a functional control or active control, they are more—they do want those responses I mentioned, but it seems to be less critical to have the actual subperceptual. We will see. I mean, again, we haven't provided any color on that yet, and it's going to depend upon the results. Finally, on the phase III, again, all of it depends. The timeline for that, it all depends on the phase II results. We'll guide appropriately once we have that data, we've had a chance to digest it, we've had interactions with the FDA. Can I add one thing there, if that's all right? Another important distinction is the dosing model and the delivery method. BPL-003 is an intranasal formulation, and it's a single administration per clinic visit. I think we believe from a kind of regulatory and commercial uptake perspective, that has very significant advantages. The intranasal device is extremely similar to what Spravato currently uses and is being used widely in the U.S. and beyond already. Similarly, it is a single administration at the visit, just as per Spravato with this kind of two hours in the clinic model, whereas GH has a kind of an inhalation device, and they have an individualized dosing regimen where you have up to three doses per clinic visit, depending on a kind of subjective questionnaire. It is a more unusual approach. I think that is another important point of differentiation for BPL-003. Yeah. Critical point of differentiation. Thank you. Your next question comes from the line of Elmer Piros with Lucid Capital Markets. Your line is open. Yes. Good morning, everyone. Srini, I do not think—I mean, Compass was mentioned briefly here, but there is a big event obviously coming up. Do you still retain a stake in Compass Pathways? Yes, we do. We are just around 7%, +- 7%. Okay. Thank you. If you think about VLS-01, would you explore a different indication other than depression for that compound? I mean, I think this is all TBD. Once again, it depends on the results. We're pretty confident on depressive symptomatology at large with that compound. There have been sort of two data sets that have been generated with DMT that are double-blind placebo controlled, albeit small ones. One involving Ayahuasca with a seven-day endpoint and no monitoring beyond that. Small Pharma had one with an IV formulation. Around 25-30 patients in both of those. They are small, but they are placebo controlled. Let's see how this all plays out. We have lots of optionality between these two compounds. Of course, there are other indications that are intriguing, whether there are other forms of anxiety, including GAD or PTSD or other things. There is, again, plenty of optionality here. Thank you. Thank you very much, Trini. Maybe Cosmo, just one question on ELE-101. I would like to also offer my condolences. What will be the future of that compound now that it is not part of this transaction? Thanks so much, Elmer. Yeah. The ELE-101, the reason why it is being carved out is a couple of reasons. Firstly, obviously, with BPL-003 and VLS, both short-time in clinic assets being developed for depression, we thought a third in the pipeline might not be totally needed in terms of focusing the pipeline and the resources. In addition to that, we really believe ELE-101 has some really exciting initial data and a lot of potential to create additional value for shareholders and, more importantly, a real difference for patients. The idea is that that is going to be spun out. The combined company will still have a stake. It will be the existing shareholders having the same pro-rata ownership. We will look to create a company there that can develop ELE-101 as its lead asset. Yes. Thank you. Thank you very much. I will turn the call back over to Srini for closing remarks. All right. Again, very exciting day. We've been building toward this for a while, as I mentioned, and I've mentioned in different contexts that we, being Beckley and atai, made the decision to—atai made the decision to invest based on our familiarity with the team, our personal relationships with the team. We've been working together closely for 18 months now, and it's been a very fruitful interaction. We are very excited to actually take this next step. Truly looking forward to the readouts and starting with BPL-003, but again, RL-007, BPL-003, VLS-01, and EMP-01. It's going to be a very exciting year for the combined company. I want to thank all of you for your attendance and your great questions. Actually, with that, I'm going to hand it over to Cosmo for any additional closing remarks. Thanks, Srini. No, thank you, everyone, for your questions and support over this period. Like Trini, we are really, really excited about what's coming up over the next year or so and really excited about joining forces for that next chapter because we think it's exactly the right thing. We're going to make the most possible difference for patients by working together. Thank you to everyone who's got this over the line. Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.