Thanks for joining us for our third day at the Leerink Partners Conference in Miami. I'm Marc Goodman, one of the biopharma analysts. We're lucky to have Srinivas Rao, who is the CEO of AtaiBeckley, for our next session. I'm gonna let you just- Yeah Make an opening comment before we kinda jump into it, but thank you for joining us. Yeah. Thanks for having me. Yeah, as mentioned, Srini Rao, CEO and Co-Founder of AtaiBeckley. AtaiBeckley is a company that's really focused on mental health conditions, ones with very large unmet medical needs. We're really focused currently on depression, the depression space, as well as social anxiety disorder. We have a pipeline that's fairly advanced at this point and really moving along, so three assets. The first is something called BPL-003. That is an intranasal formulation of Mebufotenin or 5-MeO-DMT, so it's a psychedelic compound, in development for treatment-resistant depression. We have a second asset, VLS-01. That is DMT in an oral thin film formulation, also in TRD phase II-B. Then finally, we just recently had results for the third asset, EMP-01, which is R-MDMA, and that was tested in an exploratory study in social anxiety disorder. We have three assets. Yeah to go through here. Yeah. Yeah. Yeah. Make sure everybody understands. I mean, I think the first thing is, well, let's start with BPL-003, and it's 5-MeO-DMT. I think that's probably a product that people are less familiar with than some of the others. Maybe you could just describe, like, how does that work any differently than maybe an LSD or a psilocybin. Yeah. DMT, psilocybin, LSD, et cetera, these are all considered classical psychedelics. What that means is they hit 5-HT2A, and that seems to be absolutely required to get that psychedelic effect. They are all different, however. They all hit a lot of other receptors. Subjectively, they tend to be different. People just note a very different experience across all these compounds. You know, this one tends to have a lot of 5-HT1A. That's what really drives the pharmacology, maybe underlying the different subjective effects. It's a little bit hard to know that at this point. In general, what these compounds are doing is sort of twofold. The first is they are causing very large amounts of neuroplasticity, and they're doing this in the context of marked network disruption. It turns out where the neuroplasticity is kind of focused is in circuits that are dysregulated in many psychiatric indications, including depression. Rumination is prominent and negative, you know, sort of negative self-referential thoughts are common with both anxiety and depression, and those circuits are the ones that get altered acutely. Their activity gets altered acutely in this context of high levels of neuroplasticity. That's what we think is happening broadly, and again, there are some subtleties here with 5-HT1A also modulating that. What proof of concept do we have that this product actually helps depression? Yeah. We actually ran a large phase II-B study and reported the results last year. I think it was in July of last year. Substantial trial. It was roughly 75 for two of the arms. We had a 12 mg high dose. We had a 0.3 mg low dose, and that was about 45 for the intermediate dose of 8 mg. The initial hypothesis going into that was that we, I should say it's one administration primary at four weeks, I mean, eight weeks of blinded follow-up, then an open label extension, where it's one additional dose and another eight weeks of follow-up. Okay. The initial hypothesis was that there'd be a therapeutic index difference between the eight and the 12. We are anticipating better efficacy with the 12, but, you know, maybe some more side effects, adverse events. What we found is that numerically, 8 mg is actually superior in terms of efficacy and adverse effects. I mean, both were very well tolerated, but adverse effects were lower with the 8 mg. Actually, that's what we decided to move forward with. Efficacy at the four-week primary endpoint was pretty comparable to what you see with SPRAVATO monotherapy, et cetera, but SPRAVATO requires eight doses over four weeks to get to that level of efficacy. This was one dose and getting to that level of efficacy. This is the MADRS score. Mm-hmm. What kind of change on the MADRS score was this? You know, 6.2 point change. Yeah. 6.2-point change. Yeah. That's delta versus placebo. Yes. I mean, that's pretty substantial. It's very substantial. Yeah. Okay. We have a great study, and then what did we do? What did you decide? We reported out the open label extension results. Those were very supportive as well. Yeah. The second dose added to the efficacy. Yeah. Talk about that a second. I think that's important because I think one of the big questions everyone has, and we still have, is, you know, duration, right? I mean, that's a big, big deal here. Yeah. Just slow that and just give us a sense of what happened in the open label. Yeah. In terms of durability, it's worth actually going back to the core study. Yeah. At eight weeks, we still had, I believe it was around a 5.5 point delta, between placebo and active- Mm-hmm in the 8 mg arm. When you gave the additional dose, you actually, with 8 mg and then everybody got 12 mg Mm-hmm. ... in the open label. The group that got 8 mg originally and then 12 mg continued to actually get better, and you saw remission, a response remission rates about 80% and roughly at two-thirds, 66%-ish, at the end of it, that total of 16 weeks and two doses. Right. Really good results. The nice thing about BPL is both BPL and VLS, the second asset, is that they're short duration psychedelics. They were designed to fit into the paradigm that J&J has established for SPRAVATO. Ideally, what our label will look like, and that's the data that we're generating, is that you come in, you get dosed, all the subjective and physiologic effects for the most part wrap up well within two hours. Most patients are actually ready for discharge in about 90 minutes. You are then monitored for two hours, and then you are medically assessed and you go home. That's basically what SPRAVATO has. Right. That's. Is that four hours? Two. T-two that you're having the experience? No, it's actually less than that. two for the experience and the wrap-up is what you're saying? Yeah. Yeah. In other words, you know, we had a readiness for discharge questionnaire that was really based upon the summary based on approval of SPRAVATO. You know, the things that they looked at. Right. SPRAVATO's basically you take the intranasal and then you wait two hours. Yeah. Right? It's that same thing here, is what we're hoping. Right. That's the data we're generating. Yours is dosed how? Intranasal. Intranasal. Just like SPRAVATO. It's the same thing. Yeah. I wanna go back to the data for one second. Yeah. I wanna talk about the experience. The data basically showed that after eight weeks you had the 5.5- Yeah. Delta, and then you said everybody, the open label. Yep. The 8-mg people went to 12, the 12 went to 12. The 0.3 also. Yeah. 0.3, right, through. There was a clear break from the 0.3, so there was no issue there. Where were we out at that extra time, and how long was the extra time open label? That was another eight weeks. Eight weeks. Okay. That was a final data point there, and there was the continued kind of improvement in the MADRS over that period of time. Mm-hmm. Which is really interesting. That was if you went from eight to 12 or 12 to 12. It didn't matter. Eight to 12 actually looked better weirdly than 12-12. Yeah. Big picture, if you you know, I mentioned that numerically eight looked better than 12. Yeah. Yeah. I think the issue with the 12 was it was probably a little bit too high a dose. Mm-hmm. Right? I mean, we had a little bit more anxiety that was generated there, for example. No one's really done this before, like true dose ranging. Like with, you know, psilocybin and LSD there was a lot of data from, you know, literature about what sort of a dose you should use. Here we altered the pharmacokinetics, we changed the route of administration. Typically 5-MeO-DMT is sort of inhaled, right, when used recreationally, so very different pharmacokinetics. We actually did proper dose ranging in a phase I. We picked, you know, as normal the MTD essentially, right? That's what you normally run into a phase II. Yep. You do something lower than that, and that's exactly what happened here. Right. What you're thinking here is that it was over the course of that extra eight weeks, so 16 weeks. Yeah. People were dosed twice. Total of twice. Yeah. Total twice. Is that, you know, how you're thinking right now? Yeah. Twice every six weeks, is that kind of how you're thinking about this? Or- Not so much. It may not even be that much. No, it isn't. We just announced the results of our end-of-phase II meeting. Mm-hmm. What we aligned with the agency on is two trials, two phase III t rials. The first has about 350 patients. It has three arms, so it has true placebo, it has a 4-mg dose, and it has an 8-mg dose. Mm-hmm. That's two, one, two. Mm-hmm. Primary endpoint's four weeks, just like the phase II, and that's important. 12 weeks total of blinded. Okay. There's an open label, and I'll get to that in a minute. The second phase III trial is very similar to that. It's only two arms, so it's just eight and 0. Right. It's two doses within that four weeks, so two, you know, basically dose at day one, then 14, then the primary endpoint like 28. Then, you know, again, 12 weeks of total blinded, so eight weeks more of that. Right. That's what we intend, that's what we assume is something. We'd like to give the doctors flexibility in terms of induction. Right. You have 1 or 2 doses. The open label is a dose every 12 weeks nominally, but it can be moved up to 8 weeks if the patient is, you know, having kind of a recrudescence of their symptoms. Right. Interesting. Yeah. Okay. 'Cause we can do that because we're a short duration. That's. Yeah. That's the key. I mean, our durability numerically frankly was actually better than psilocybin. Yeah. If you look at the slopes. Yeah. Right? I mean, the only reason we're doing this is because, you know, most people getting SPRAVATO are actually getting it every week, and so people can tolerate a Yeah. short duration to our experience. Right. I mean, some, not many, but some people will have, again, their symptoms are gonna start coming back, so we wanna be able to catch it early. Right. That's why we have the eight week. Is there any way to describe the experience on a relative basis to SPRAVATO or to psilocybin or, you know? Spravato is different, right? I mean, that's a dissociative. Yeah. You have perceptual alterations, particularly in the early doses. Colors may shift and things like that, but it's not a true psychedelic experience. The other compounds in question, LSD, DMT, psilocybin are true psychedelic. Right ... compounds. It's a little hard right now to actually fully compare what the effects look like in any kind of detail. We're analyzing that. Mm-hmm. We did something called the MEQ30 in this particular trial. That's the Mystical Experiences Questionnaire, 30 questions, that attempts to characterize the nature and the depth of the psychedelic experience. Yeah. We haven't really got all that data just yet. Yeah. What you've seen so far is that people enjoyed the experience? Did they- Yeah. Not enjoy the, you know. No. Well, they enjoyed the experience. Right. They found it to be meaningful to them. Right. 90% of folks where the second dose was offered, we talked about the open label. Yeah. It wasn't available at all sites immediately. Mm-hmm. where it was eligible, 90, 85% rather did Yeah Did get it. The intensity of the experience on a relative basis to LSD. Which is probably the most intense, I guess. Yeah. Depends on the dose, right? Yeah. There are a couple of scales that look at subjective intensity. Yeah kind of acutely, so those are the SIRS, which is literally that, Subjective Intensity Rating Scale. 25 mg of psilocybin is sort of in the seven to 10 range. You're not pegging out at, you know, 10. Mm-hmm. The 8 mg is kind of in that same range. 12 is really on the higher end of that range. It's similar. Yeah. To psilocybin in terms of overall intensity, not necessarily the nature of it. That latter part we still have to manage. Right. Let's talk about the other two assets and then let's come back and talk about, you know, just commercial. Sure. How you're thinking about each one of them fitting Yeah, yeah. to the landscape and stuff. Let's move to the second asset. Tell us about that one, the VLS-01. Yeah. VLS-01 is an oral thin film formulation of DMT, so dimethyltryptamine. Sounds a lot like 5-methoxy-N,N-dimethyltryptamine. It is very different pharmacologically. DMT, you know, 5-methoxy-N,N-dimethyltryptamine is kind of the active moiety in the toad venom, right? This one is the active moiety in ayahuasca. Mm-hmm Which is a brew, that's, you know, that has been used in different ceremonies and stuff in South America. That's where that originated. There was previous data on ayahuasca being effective in treatment-resistant depression in a small double-blind placebo-controlled trial. More recently, there was a publication of IV DMT, so very different PK, and also showing efficacy that was about 33, 34 patients total. Good efficacy there too. You know, relatively de-risked assets certainly compared to 5-methoxy-N,N-dimethyltryptamine. Our trial there is a phase II-B, as I mentioned. It's 142 patients, roughly, so it's 71x two arms. Here we're doing two-dose induction. We've got placebo and then two-dose induction. It looks a lot like that second phase III. Two doses, two weeks apart, primary endpoint at four weeks. Mm-hmm. 12 weeks of follow-up. Again, looks a lot like the phase III- Right. for the other asset. Okay. Yeah. From a proof of concept there, you're basically referring to the publication of ayahuasca in a different formulation that's Ayahuasca is very different. DMT and 5-methoxy-N,N-dimethyltryptamine are not orally bioavailable. Yeah. They get kind of broken down, before getting absorbed. Ayahuasca is a brew that people drink ceremonially. Yeah. It's multiple plants, but the key plant is Psychotria viridis, and that's where the DMT is. You put another plant in there's a couple of different ones that give you a monoamine oxidase inhibitor. That's what allows oral bioavailability, such as it is. Yeah. You know? That's how. But it's a very different pharmacokinetic profile, low and slow. It's a 4 or 5-hour experience. That's what I was getting ready to ask. Yeah. It's 4-5 hours. Yeah. Interesting. Yeah. The phase II is about to start. Is that what you're? No, the phase Well into it. Two is well into it. We will have results in the second half of this year. Oh, okay. Yeah. That's great. Yeah. It's about a year and change behind BPL-003 essentially. Okay. Now let's move to the third asset. Yeah 'cause I wanna get to the whole commercial business model stuff. Yeah, yeah. Of course. Tell us about EMP-01. Yeah. EMP-01 is a single enantiomer of MDMA. MDMA has been tested for PTSD, shown reasonable results, but there were a lot of confounds with the studies that were conducted. Yeah. This is the one. It makes sense that it should work. Yeah. When we tested R-MDMA. We looked at the racemate. The S-MDMA is actually very amphetamine-like, and so it causes tolerability concerns. The R enantiomer is much more serotonergic, so we thought that's where most of the beneficial effects are really coming from. That's what we wanted to test. We tested that in the phase I trial. We found some really interesting results. I mean, the compound was much more traditionally psychedelic and we had much more in the way of psychedelic effects, but it maintained some of these entactogenic, empathogenic effects that MDMA has. A really unique profile. We wanted to explore that a little bit further. This one is orally bioavailable, so this is, you know, this was powder in a cap for the phase II-A. With the phase II-A, we decided let's do two things. Number one, learn more about this compound, and number two, let's go look at a different indication. 'Cause most of the trials currently with psychedelics are in anxiety or depression. Mm-hmm including our own, right? We wanted to go look at something different that also had large unmet medical need, and that was social anxiety disorder. Huge indications like, you know, 15 million people approximately, or 15-18. There's, you know, if even if you just say arbitrarily about a third of those are quote-unquote treatment-resistant, that's still twice as large as treatment-resistant depression, and there's no competition right now. There are three old approvals from the early 2000s. Two SSRIs and then one SNRI. Yeah. Those were line extensions. Those are the only approvals, but there was a regulatory endpoint. We threw that in. Exploratory study, primary endpoint was safety, 'cause again, we wanted to understand the drug. Secondary endpoint was a so-called LSAS, so Liebowitz Social Anxiety Scale. That was the regulatory- Yeah, that's the endpoint. Yeah. A small study, unpowered, 70 patients total, 35 times two. What we found was that at six weeks we had an effect that was very comparable to what SSRIs, et cetera, get at eight to 12 weeks. The key here is that the LSAS doesn't measure a symptom like the MADRS does. Mm-hmm. The MADRS. Your symptoms can change quickly, right? You can ask the MADRS four, five, six hours after you take the drug and you'll see a marked improvement, right? You can't assess behavioral change that quickly, right? It just doesn't make sense. Yeah. You don't know what your behavior's going to be. You need to actually be exposed to situations where you can actually be tested, right? Yeah. That you test yourself. You know, it takes time to get, as I said, behavioral change. We were seeing behavior change by six weeks in a way that is unlikely to be seen. You know, there was a pattern here. Mm-hmm. There was both fear, which is what SSRIs tend to address, you know, they kind of blunt your fear response, but you were also seeing avoidance behaviors change very quickly. This is more like CBT, you know, cognitive behavioral therapy. That was really cool. The KOLs that we worked with were really excited by those results. It's a very, you know, again, positive trial from an efficacy perspective for what it is, an exploratory study, so we're pretty excited about that. This is the R-isomer of MDMA. Yeah You, has anyone tested the R- isomer before? It turns out to be hard to test. Normally, when you wanna test a single enantiomer, you just purify it, right? Yeah You use a chiral column or something, and you can clean. You can get the enantiomer. It turns out to be difficult because you don't get good purity that way. You have to enantiomerically, you know, do stereospecific synthesis to get that. We had to go through that process, got very pure compound that way. There have been people that have certainly been toying with R-MDMA, but some of it probably had a fair amount of S-MDMA contaminants. Right. Okay. This product is just a simple capsule that you take. At this moment it is, yeah. Right. That's, is that the goal? I mean, we're still looking into that. Yeah Right now the subjective effects for this are around six hours. It's fine because it's an early-stage asset. Certainly, the two leads are fitting the SPRAVATO mold. Right This is more like a psilocybin in terms of total duration. It is shorter, one would anticipate, than an LSD, which are the other two. You know, those are the two programs. Yeah. I don't really know exactly where we end up. LSD could be seven hours or eight hours. eight hours, 10. I mean, Yeah, I mean. That's just, you know, we looked at LSD in different contexts, but the commercial viability of that was always something that we had some. Yeah concerns about. Psilocybin is probably six- four to six seven, yeah. It can absolutely go over. Yeah Your patient shows up late, they eat a big breakfast when they're not supposed to, so it kinda slows down absorption. Right They just have a longer experience, or they just have, you know, blood pressure that remains elevated. I mean, that happens, right? Yeah. It happens with SPRAVATO. Yep You need to monitor them. You can't discharge them. I mean, with psilocybin, you maybe have a little bit of cushion. Yeah a little bit of buffer. LSD, I don't know how you have much in the way of buffer. Yeah. These three products, let's just go through. We have this one we're just talking about. Yeah EMP-01, which right now is an oral, and you're talking about a six-hour effect. Yep This is kind of how you're seeing it right now. It wraps up, like I said, fully, full resolution within six hours. Yeah, six hours. You have the VLS-01, so that is how long? Right around two hours also. That's a two-hour experience. Yep. Okay. The first product we talked about is a two-hour experience. I mean under. Both of those are under two hours. Right We anticipate full resolution by 2, yeah. We can just put them into. Yep SPRAVATO business model, so to speak. That's right. That's That's right. That's it. Exactly. That's it. Instead of trying to break out of the- Yeah As far as duration, we're still exploring it, but it's looking like you're experimenting with this double dose type of idea too, right? I mean, that's. Yes 'Cause that's what Compass was trying. Correct to do a little bit too. You know, obviously they're exploring as well. Yes, of course. Everyone's exploring here. Okay. Let's talk about, like, the landscape of, you know, how these psychedelics fit into the world of whether it's depression or whether it's anxiety or social anxiety, whatever it is. Talk about, like, the infrastructure that's out there, what you expect that infrastructure to change by the time, you know, your product gets in, how you'd like to help the infrastructure change. Yeah Just give us a sense of how you think about this? Yeah. This space, it's basically, these are all entries into a space called interventional psychiatry, right? Yeah. This is different than normal psychiatry from back in the day, where, you know, if you have a recalcitrant patient, you come in and then they give you something, and you go home and take it chronically, right? That was the model. Ketamine, there were devices, right? Yeah. rTMS and things like that. Yep. That's where interventional psychiatry, in a sense, started. I mean, you could argue it started even earlier with electroconvulsive therapy. In terms of mainstream adoption, it was really rTMS. The next big change there was ketamine, off-label. Right. IV or IM ketamine. Why was that revolutionary? It's that it allowed for rapid symptom relief, right? Yeah. All the SSRIs and SNRIs and atypicals and blah, blah. Yeah They all take a long time. Yeah. Months. It's pretty modest efficacy. Yeah. Ketamine had rapid efficacy. The problem is it does not have durability, right? You have to take it frequently. Yep. SPRAVATO was the first real branded product that is in this model of interventional psychiatry. That, obviously J&J brought this to market. We are all so lucky it was J&J, 'cause they had to do a lot of work. Yeah to get this to where it is. It was $1.7 billion-ish last year. Yeah. Probably closer to $3 billion this year. Right It's done. The strange thing is, for the first two years, it wasn't much of anything, 'cause they didn't report the numbers, so they couldn't. They did. Well, it wasn't material to them. I was gonna say, they weren't material. Yeah. I mean, in all fairness to them, this got approved in 2019, and then launched essentially into COVID. Yeah In an interventional psych thing. Yeah, that's true. That wasn't great. Yeah. It, they did do a lot of work in setting up these clinics, understanding all the reimbursement and everything else. That is the infrastructure that we want to exploit directly. Right We had a KOL panel. We actually had an Investor Day on Friday. We walked through the data, the end-of-phase II meeting. We also walked through IP, which is quite robust for us. Importantly, we walked through the commercial. We had the KOLs. The KOLs were basically like, you know, "There is no reason I wouldn't switch everybody from SPRAVATO," I mean, "to this." Because SPRAVATO is again 70% of individuals are getting it every week. You're losing a day out of your life every week. Yep That is just nuts. It also geographically constrains you. You're not driving. Well, you can drive there, but you're not driving back. Yep Right? Those Uber rides are gonna add up if they're far away. Essentially, the decision that many people are having to make is, I want to feel better or I want to have a life. Mm. By that, I mean hold down a job and, you know, be part of the kids' life and all that kind of stuff. Yeah. We think we can fix that problem, and we can fix it in the same context, you know, to our relatively easy experience. The other thing that the KOLs really highlighted was just how exhausting those long, longer psychedelic experiences can be, right? You end up coming out of those tired and wiped out. Mm-hmm. Yeah, if you think. You know, we've been talking about 2 hours, 6 hours, 8 hours. The other metric you can sort of think about is where the most intense experience is and how long that is. Like, we talk about SIRS and SDI. Yeah. Like, a four, five, six and above, right? That's really short for SPRAVATO and, I mean, for VLS-01 and BPL. It's, you know, it's 30 minutes, maybe an hour at the top end. Right. For the other drugs, it's three to six hours. Four, you know, three hours, four hours, five hours, somewhere. Right. Right. It's so much shorter. I think that's a really exhausting, emotionally draining element and you just don't have it. Right with ours. How many of these sites exist today that would use your product, so to speak, that would offer? Yeah Your product if it was approved? Right now, you get different numbers in terms of the number of sites. Yeah that are in the United States, have gone through the REMS process. It's somewhere between 5,000 and 6,000. Okay. As of about a year ago, we learned that about 600+ were actually responsible for about 80% of revenue. It's really on the order of 10%-15% are driving much of the revenue. 600 sites. You've spoken to some of these people at- Yeah these sites. Yeah, yeah. Are these one-off places that have five rooms or are they a big center that, you know, has a lot of doctors and, you know, just kind of? I think, I mean, the ones we talked to were more in the former mold. Uh-huh. Actually, that's not true. The academic sites do have multiple docs. Right. ... and many rooms. Yeah. I mean, just give people a sense of like. Yeah. What it looks like, one typical place looks like. Yeah. The one that I'm The economics. Yeah. The one that I'm most familiar with is one in San Diego. A guy named David Feifel. He was one of the KOLs who was up there. Basically, wonderful facility. You walk into the doctor's office, obviously get checked in. There are multiple rooms in the back. Mm-hmm. He's running clinical trials, but he's mainly doing ketamine, esketamine. Mm-hmm I think mainly esketamine at this point and rTMS. You basically are inside this room, comfy chair, you're kind of reclined a bit. You're given the drug. I, rTMS is different, but you're given these drugs, and eye shades, music is basically what happens. There's AV monitoring, and pulse ox, and blood pressure. You're in a room by yourself. You're in a room by yourself. It's a small room, and there's. Yes. ... how many of these rooms at Feifel's office? Wow. Five or- I was gonna say maybe six or seven. Close enough. Yeah. Yeah. Yeah. There's six or seven that could be doing this at the same time. They are typically doing it at the same time. Somebody could be in there for 6 hours on a study for psilocybin, and someone could be in there for 2 hours on a study for you. Yeah. No, I'm talking about just the clinical study as a research side. Yeah. The clinical side is all the ketamine, esketamine. Mm-hmm. The other side is doing these longer duration studies. Right. All right. If all of these products are approved- Yeah Let's just say all three of yours are an offering, everybody else who you're, you know, so to speak, competing with out there, everybody's there. Yeah. How do you think this plays out? I mean- Well- It's like a menu? Like, you know- Yeah. Which one would you like? Maybe to a degree. The thing with treatment-resistant depression in particular is it's a very untapped market. Yeah. We've been talking about the numbers for SPRAVATO. It is around. The TRD on a conservative estimate is just around 3 million people. Yeah, I believe that. We are tapping about 3% of that with SPRAVATO now, and that's what's giving you almost $2 billion in revenue. Yeah. That's how to think about it. We do have currently two assets in TRD. They are by far the most convenient assets. Again, it's worthwhile, you know, don't take my word for it, right? I mean, it's worthwhile listening to the KOLs. Yeah Talk about how important that short duration is. It's important for the patient for the reasons I outlined, you know, in terms of how exhausting the experience can be. It's also critical from the site perspective. It turns out to be very exhausting. You know, in the case of psychedelics, the FDA wants someone in the room. It's just this old thing that. In the office, not necessarily. In the room. in the room with them. In the room. Someone has to sit in the room? Yeah. In the real world, someone has to sit in the room, do you think? In the real world, that's a different story. We don't know. I'm just talking about the clinical trials. Right what the agency. 'Cause I was kind of imagining those six rooms with the little camera in the corner and. Yeah Someone sitting in the main office. Yeah. Oh- With a panel. Yeah. Yeah. Mrs. Smith in room five needs. Yeah, that's what happens. Yeah Some help. Okay, let's go see Mrs. Smith. Is that, you know, or you're saying someone's actually sitting with Mrs. Smith? With the psychedelics, because of a long and sordid history. Mm The agency has been requiring, initially two people in the room, but now they've softened it to one person in the room. Right As long as there's AV monitoring. Yeah. The storied history, well, some of it is just, you know, there was a publication from Johns Hopkins kind of reviewing all the very ancient literature. Yeah. They always had a couple people in the room. More importantly, we talked a little bit about MDMA. There were allegations of sexual assault that Yeah occurred during some of those clinical trials, and that's why they now have two people. It's the most ludicrous scenario. Yeah. I mean, it's like, okay. Right. Okay. In the real world, once we have multiple products and the FDA's probably not involved anymore really, right? Right. Right. Because unless- It'll probably shift. Yeah. Yeah, it probably will shift. What about the economics? Yeah, the economics are. How much are you gonna make? How much are these sites gonna make first, you know, for your product, for instance? Right now what we're estimating for SPRAVATO, I mean, what we've seen for SPRAVATO is over 70 or 70% are getting every week dosing at the high dose, and so that's around $65,000 a year just in drug costs, and then there's additional CPT codes for reimbursement of the clinic time. Mm-hmm. Just the insurance is paying for both, but just drug costs is $65,000. Obviously we think we can improve on that. You know, we certainly are improving on it in terms of durability. We think we can also. I mean, you're not paying for all that time in the. You know, there's the other CPT codes, which are not as. They don't give you the same level of reimbursement, but they do give you some. Mm-hmm. The insurance company won't be paying for it. Our value prop for the sites is very straightforward. I mean, we allow each room to be used for multiple patients in a day, right? Just like SPRAVATO. That's what the high volume docs wanna see. Right. The longer duration drugs do not do that. There is another CPT code, as I mentioned, for just time and chair. That is much lower than actual dosing with these buy-and-bill models that these docs are using. They get the most money, you know, just, again, kinda crassly, they get the most money for each dosing, and not for chair time. Mm-hmm. They want that. They want that kind of flexibility to get patients in. Things happen, right? Someone doesn't show up. If you have booked a room for an entire day, you're out. That's it. Yeah. Right? In this case, you certainly have more patients, and you can probably call them in also if you need to. Right. I mean, when I'm thinking through it, of course, I think people would like a good experience, and they wanna feel better, right? Yeah. That's number one. Yeah, yeah. Number one. You know, if we have multiple products that make you feel better, great. Now we can kinda move to the next level of, okay, well, how long am I gonna feel great? Yeah. If that's kind of all equal to, then you move to the next level and you say, "Well- Convenience How?" Yeah, convenience. Yeah. Exactly. I mean, I'd much rather only spend two hours than six hours. Yeah Kinda goes without saying. Yeah. You know, if everything else were equal. If everything else is equal. You know what I mean? Like, I think that's your point. It's like. It is. That's exactly it. It's like we're basically starting to put data out there where Yeah That's kinda the case. That's kinda the case. You know, there's other pragmatic considerations. We've talked a little bit about, you know, having a sitter in there, in that room, turns out to be very exhausting for the sitter. It's a long day. Yeah. Right? This way, they kinda can go through multiple patients. Yeah. Yeah. I mean, I know we're out of time, so. Yeah, I know. So Just looked over there. I'm like, "Wow, okay. Okay. That went fast. That did go fast. It's a very interesting conversation, and I'm just fascinated by this stuff. I mean, it feels like it's like the industrialization of this. Yeah Right? Yeah. And s- 'cause- Medicalization. Yeah. Yeah 'Cause what you were describing before, you know, two in the room and all that stuff, that, I mean, that was the early days, right? Yeah. I mean, there's a lot of just. This is much different. It is. The companies are a lot more very professional, corporate companies like yourselves and some of these others. Yeah. Absolutely. That's good for everybody. It is, absolutely. Yeah. Thank you for joining us. That was great. Marc, a real pleasure. Yeah. As always. I really enjoyed it. Yeah. Thank you.