It's a pleasure to be here with Soleno Therapeutics for the next panel here. We have Anish Bhatnagar, CEO, and Jim Mackaness, CFO. Thanks both for being here. Maybe we can just start with kind of a quick overview of the recent quarter and anything you kind of wanted to specifically highlight, and then we can dive into some Q&A. Sure. Firstly, thanks for having us, James. So, as you know, our last quarter, Q3, was outstanding. We had 397 start forms. We had revenues of $66 million, which was double of Q2. We were profitable and were moving forward with about more than 130 million lives covered. So, from an access perspective, very positive quarter as well. So, overall, things have moved forward quite significantly. As you also might have seen, we had a stock buyback yesterday. We believe the market has undervalued what we are doing, so it made a lot of sense. Makes sense. And yeah, I mean, I think, like you said, objectively, it's like $100 million in two quarters, profitable, et cetera. I think what may have spooked investors a little bit, which is the commentary maybe suggesting that scripts were flattening coming into 4Q in October. Can you maybe kind of walk through that again? Is that sort of the right takeaway from your messaging? Yeah, it's not the right takeaway because we actually, if you think back at the time before launch, we always said that we don't know if there's going to be a bolus because there's never really been a drug launch for hyperphagia in PWS. We don't know if there's going to be a bolus. And based on our conversation with key opinion leaders and large practices, we saw that patients would be coming in for their regular visits and getting the script. So, to us, it was always going to be a slow build of patient scripts and revenues. Now, we did see a bolus, and it was a very large bolus. And as we were trying to explain, we think that the bolus starts to slow down in the July time frame. And when you look at August, September scripts, the new patient starts were lower, and October seemed similar to the others. So, for us, it's normal cadence of what we expected, and we think this is what we need. So, if we can keep a cadence like this, and we had in Q2 and Q3 combined 10% of the TAM in six months. So, if we can conservatively hit another 10% of the TAM in the next 9 to 12 months and do the same again, this is going to be a billion-dollar drug at the end of that. Yeah, okay. That makes sense. And I guess as we think about 4Q in general, how should we be thinking about patient growth specifically? Do you expect to see kind of net patient growth in 4Q, or is it maybe going to take longer to get through some of these kind of dynamics that you guys kind of highlighted previously? I think we will continue to see net patient adds. There's no doubt in our minds about that because if you look at our discontinuation rates, if you're in the 8%-10% zone, even if you are normalizing that towards what we think will happen in the longer term, we're still going to be having net patient adds for a while to come. So, we don't have any doubts about that. In terms of Q4 and going into early next year, we think the cadence that we have seen in late in Q3 and early in Q4 should continue. It's going to be lumpy with holidays and what have you, but we think in the intermediate to long term, this will smooth out. Yeah, okay. And I guess as we think about to 2026 and kind of next year, it sounds like we're not reaching any sort of plateauing in terms of what you think in terms of patient growth from here. Yeah, we don't see a plateau. We think that just reminding you of the TAM of 10,000, this is a rare disease, but it's clearly not ultra rare. There's a lot of patients out there, and we don't need all the patients, and not every patient is a candidate. So, as you know, the claims data shows about 12,500. We think our TAM is somewhat smaller than that at 10,000, and we're at only 10% of the TAM. Yeah, yeah, okay. So, yeah, 10% of the TAM. And I mean, it sounds like you think we could be at 20% of the TAM next year. A year from now, yes. Yeah, okay, okay. And it sounds like that 10,000 is still the right TAM to think about in terms of even as you kind of seen this play out in the real world. Yeah, I mean, we learn as we go. This is a new indication, but today we don't have reason to believe that the TAM is different. Yeah, yeah, okay, great. And then, yeah, I guess just generally, and you're kind of sort of answering it, but as you look at sort of how the street's modeling in 2026 and kind of beyond, are people being too optimistic, not optimistic enough? And I know you can't be specific, but just curious your perspective on how the investment community is thinking about it and if there's any sort of disconnect. I'm going to let Jim answer that. Sure, yes. No, I think long term, the way it's being modeled is great. It is a sizable opportunity, and I think the models reflect that ultimate commercial opportunity that we can get to. So, it's very exciting. I think, as you said, the goal is for the 10% of the first six months, add another 10% the next 9 to 12 months, and continue to do that. You can see this thing becoming a significant size in two, three years. I'd also comment that when we talk about that 10,000, really to emphasize that, I think that's identified patients. That's patients in claims. It's not a prevalence. So, we literally have analytics going on to target them to get core patterns to better reach it. So, there's another number of reasons why we have confidence of being able to continue to sort of penetrate further and further as time goes by. Yeah, yeah, that makes sense. And I guess in the context of all of that, is that kind of why you did this buyback yesterday? And yeah, maybe just any more color on kind of what gave you the confidence to trigger that? Obviously, you're profitable now and have the cash, but confidence that it was the right sort of decision. Yeah, I think we saw the disconnect in the near-term value being reflected in the share price and what we think is the ultimate value for one. To your point, a little bit of an unusual instrument to use, but we find ourselves in a little bit of an unusual time. And then, as you said, I think the backdrop is we had over $500 million of cash. We are cash flow positive. We anticipate remaining cash flow positive. So, this just seemed like a very good opportunity to take advantage of this and put the ASR in place. Yeah, yeah, makes sense. Okay. Any other specific comments you want to make in terms of how to think about kind of patient growth from here into next year before we dive into some of the underlying kind of dynamics here of the launch? No, I think we just want to have people remember the overall TAM of 10,000 because people asked us, you've asked us about slowdowns and such. We're six months into launch. We have 10% of the TAM. It's been a tremendous launch. So, I think there's a lot of positives there. Yeah, yeah, makes sense. So, yeah, maybe kind of diving into some of these underlying launch dynamics. You mentioned, obviously, on the call, some patients were kind of coming off early or maybe prematurely based on their AE profile that wouldn't warrant a discontinuation. Who are these patients? Are these patients at community settings? Just curious if you could kind of help characterize who these patients are. And it sounds like you're already getting some back on therapy, but be good to kind of understand that dynamic a little bit more. Yeah, so I'm going to give you the glass half-full version of that question. So, our discontinuation rates have been 8% - 10% so far, right? We've talked about long-term discontinuation rates in the range of moving up to about 15% in our long-term clinical data. Overall adherence expecting in the range of about 80%. So, the numbers that we're talking about right now are small. So, when you think about discontinuations, we see a side effect profile of the drug, which is very similar to what we saw in the clinical trials. So, peripheral edema or things related to fluid retention, as well as things related to hyperglycemia, form sort of the main aspects of patients who discontinue. And I would say that a small minority of them have been serious, but most of them have been non-serious events. So, it's these non-serious events that we think are not necessarily not good candidates. We actually think that they can be on drug. They just need to be titrated through better. And that's what we are seeing when I referred to the fact that patients have started coming back on drug. Yeah, makes sense. And you asked, sorry, about who are they and where are they from. I would say that if you are a patient who has significant comorbidities, if you are extremely heavy, you are likely to be a candidate who will run into these kinds of problems. Anecdotally, I would say that one would like to think that if you're an inexperienced physician out there, you probably have a higher discontinuation rate. But at the same time, they also have very few patients. So, overall numbers remain small, and it's hard for us to kind of specify which patient is more likely to be in trouble other than the ones that have the comorbidities. Yeah, yeah, makes sense. And yeah, the reason I ask kind of where these patients were is because I feel like when we've talked to docs, there's maybe sort of a bifurcation where KOLs, these high-volume prescribers who are very familiar with the drug, have no issues or everything is green flags versus maybe some, to your point, of smaller practices, but in the community setting, are maybe a little bit more looking for some color around guidelines and how best to use this drug. I guess, is that a dynamic you are seeing play out? And I know KOLs have talked about it. You guys have talked about it, putting outside of more guidelines on kind of how best to use this drug. Is that something that you think is going to kind of help the broader sort of prescribing community? Yeah, it absolutely will. And you're right that if you're a physician, even an endocrinologist who's not familiar with the disease and with the drug, you are more likely to want some help. So, we're doing a lot of things. There's a lot of peer-to-peer physician education that's going on. We have a speakers' bureau. A number of experts are conducting events where they will host a number of other physicians who want to talk about the drug. We have an expert on demand program, which we have used. So, there are KOLs who are available to a physician who wants to talk about a patient or a specific drug, and they'll have a half-an-hour call with you, walk you through the situation, et cetera. So, all of that is helpful, and we think that things like guidelines will also help and from what we understand, there are a group of KOLs working on it. We're supporting the effort, and that will be helpful too. PWSA USA, which is an advocacy organization, has a set of FAQs on their website, which we think is also helpful. Yeah, yeah, makes sense. And do we want to get into some of the patient dynamics in a little bit more detail, but maybe again, in terms of these high-volume prescribers, are they at all sort of reaching capacity with how many patients they can put on this drug? Just curious what the dynamics specifically look like there in some of those bigger practices. Absolutely not. From what we understand, in fact, the very specific example, we spoke with the KOL just a few days ago. This is a person who has about more than 100 patients on practice. They expect about 60%, 70% of them to be on drug, and they have put only about a third of them on drug so far. And their biggest challenge is, just like many other KOL practices, it's an extremely busy practice, and it's nearly impossible for them to fit someone in sort of last minute. So, the bolus that they had, the third of the patients that they put on early on were people who were really sort of banging down the doors and trying to get in. But they believe that going forward for the rest of their patients, they will prescribe them when they see them in the normal cadence. And we know that the normal cadence for these people is one to two times a year. So, we don't think these practices are sort of maxing out at all. We think there's a lot of room there. Okay, okay, great. Makes sense. And then, yeah, maybe kind of diving into some of the discontinuation rates, et cetera. Again, you mentioned 8% related to AEs, 10% overall. I think that was better than I would have maybe even thought and better than I feel like we see with a lot of drugs. Where do you think that's kind of going to shake out over time, and what kind of gives you confidence to manage that to your kind of target goal, whatever that may be? Yeah, it's a good question, and our best gauge for that is our clinical trial data. So, in the long term, we saw about a 15% discontinuation rate. We think you can add some more to it for persistence, et cetera. We think an overall adherence rate of about 80% makes sense. And it's obviously something we'll have to manage, and part of the efforts are related to education. And this is not just physician education. It's also caregiver education. So, we've talked about this more recently that we have nurse educator teams out there, the intent of whom is to be the primary people that families can reach out to if there's an issue. So, they obviously can't provide medical advice, but they can provide advice on, "Hey, you don't need to wait for two weeks to call your doctor. You need to call them today. And if you need to go into the hospital, they'll tell you to do that." So, we think all of these things will help, but we think that overall, we should be able to manage it in that zone. Yeah, okay, makes sense. And just kind of on that point with prescribers, now that I think of it, I think on the call, Meredith mentioned you're adding prescribers on a daily basis. Is that right? And then, two, how is that sort of active prescribing base kind of building over time? Obviously, there's a lot of patients, a lot of unique prescribers that have written the drug, but in terms of those that are kind of continuing to write the drug, is that building as well over time? Yeah, I think it's fair to say we have a lot of repeat scripts from physicians. A lot of the one-off prescribers are truly one-off in the sense that you could be an endocrinologist in the field who has one or two PWS patients, and you wrote a script for them. But at the same time, these are people who could write more scripts because, as you may remember, we think that our top 300 physicians are either directly prescribing to or influencing prescriptions of about 4,000 patients. That still leaves about 6,000 patients. So, there's a lot of patients out there. So, we think that the KOL practices will continue to write, and we think a lot of these one-off prescribers, once they have experience, should be repeat writers as well. Yeah, yeah, but either way, there's a lot of prescribers who have a really small practice who. Correct. So, that makes sense. Okay, great. And then, yeah, in terms of discontinuations, this discontinuation rate, obviously, a piece of that is efficacy. We're now kind of six-plus months into the launch. Be curious if you have any sort of perspectives on what efficacy is starting to look like in the real world and how your confidence in that kind of helps inform your plan or your goal for where you think you can manage discontinuations too. Yeah, and just a correction on that narrative. I think there's this feeling out there that there's some kind of go, no-go decision at six months. It's not really the case because the data shows you that maximal effects of the drug are in six to nine months. But it also shows you that you start to see efficacy not too long after you start drug. And we are hearing numerous anecdotes from the field now, which are talking about these sort of efficacy things that are happening. And I'll give you an example. There's an adult who lives in a group home in the Midwest. This is a person who I believe is early to mid-40s. Parents live in Florida, much older. And one of their pain points is the fact that they have to go to this location to pick her up and bring her back for holidays, vacations, et cetera. And this is a person for whom planes have had to be turned back because of their food-seeking behaviors. And this is a person who is now able to travel alone. So, these things are subtle and may not matter to someone who doesn't actually live and breathe PWS. But things like that, things like a 12-year-old who sits through a four-hour temple service is unheard of. Doesn't ask for food for another four hours after that. That's unheard of. And these are the anecdotes that we're hearing. So, I think the efficacy piece is something that will play out over time, and for now, it is playing out the way we expected it to. Yep, yep. No, that's really helpful. And then just on sort of the safety side of the equation, I know you guys have, on the earnings call, you've shared some interesting color on sort of how real-world safety is playing out, and it's lower rates than what you saw in the trial. Maybe just kind of walk through that again and just, again, your overall confidence in how safety has kind of played out in the real world. Yeah, I think it's fair to say that the most common adverse events remain what we saw in the clinical trials. So, if you look at the label, events related to hyperglycemia, to peripheral edema and fluid retention, to rash, to hypertrichosis, these are sort of common things that you see. When you look at rates, what we talked about on the earnings call, we specifically looked at fluid retention-related events. And those events, at least from what we've seen and been reported, are lower than what we saw in the clinical trial setting. Now, obviously, this is post-marketing. Reporting is lower, but in general, that seems to be the case. And when we look at serious events, we don't see things that are on a percent basis very different from what we saw in the clinical trials. I think you have to bear in mind that when you're in a post-marketing setting, you are treating patients who are less controlled. You're also in a situation where physicians are not seeing their patients as often. So, you have to balance that, but overall, we think the safety profile is what we would have expected it to be. Yeah, okay, great. Yeah, and then I guess in the context of all of that, it'd be great to kind of hear your perspectives on what the overall prescriber, overall patient feedback is on kind of the real-world experience, what the patient advocacy groups are kind of saying. Just be great to get your perspectives on what the pulse is in this community in the real world. Yeah, we remain quite connected to the community. We work with them on all kinds of events, webinars, patient webinars, KOL events, et cetera. And we've continued to do that. Feedback has been very positive, and I think starting with logistics of treatment, starting with coverage, people have seen coverage like they have not seen in other rare disease settings with this launch. So, overall, feedback has been very positive. Okay, great. Then you kind of mentioned that there on the payer side of things, I mean, it seems like that's been going really well, but maybe if there's any more color you can sort of lay out in terms of if that's at all been a challenge or if it's really just more a matter of kind of when reimbursement comes through rather than if it comes through. Yeah, I would say we have been very fortunate with coverage. Part of it is related to the fact that our teams did a lot of disease state awareness type of education early on, even pre-launch. We have seen payments come through all channels, commercial, Medicare, as well as Medicaid. We have seen payments come in from 40 Medicaid states at this point. Medicare payments have come in. The three largest PBMs have policies in place. Policies, generally speaking, are pre-auth to label policies. We have started seeing reauthorizations, and those seem to be going through. I would say that from a coverage perspective, we're very pleased. We have more than 130 million lives covered. Now, when you look forward, it's always going to be a challenge, and we always have to kind of fight the fight. But as of now, things seem well. Awesome. Yeah, that was going to be one of my questions was, have you seen any reauths yet? Sounds like yes, and they've been kind of going through. What is sort of the criteria? Is there anything specific in terms of reauthorization? No, in general, we've seen physician attestations, which is what we expected to see. And I think the physician attestation also ends up being a sort of caregiver attestation, if you will, because a lot of time is spent by caregivers describing what they're seeing with the drug. So, we suspect this is probably the physician attestation as a result of a conversation with the caregiver, and that's what we were seeing right now. Yeah, okay. Makes sense. And then that was going to be the extension of that question is in terms of the conversation with the doctor, the family, what do you think that sort of looks like in terms of continuing on therapy? Is there any sort of formal efficacy assessment that they're going to do, or is it a little bit more kind of subjective based on how the caregiver thinks the patient's doing, for example? I think it's the latter. We don't see practices doing HQCTs. It's not practical, and it's not something that is built for clinical practice anyway. So, we think it's subjective, and it will continue to be so. Yeah, okay. Great. And then on pricing, obviously, it continues to seem like that is a tailwind. Do you expect patients, the average sort of weight of patients over time to kind of remain above what it was in the trial like we're seeing today? Is that sort of a, that's not a near-term thing that you think that's kind of over time, kind of the average weight will probably be above where it was in the trial? We think so. And the reason is that when you look at the claims data, we see patients who are 26 and below have a large number of touch points, and we think they'll be the early ones to come on therapy. And we think older patients will be later to come on therapy. So, obviously, older patients are a little heavier. So, we think the trend of being heavier than the clinical trial will continue. Okay. And within sort of a given weight band, are patients titrating all the way up to the highest dose? I'd say it's early, but in general, patients do titrate up to their target doses. There's exceptions. But as you may remember from our clinical trial data, pretty much everyone was able to. This is the real-world setting, and I'm sure we'll see some variability, but I'd say most patients do. Yeah, okay. And even in those kind of higher weight bands, no real access issues in terms of getting therapy reimbursed? Yeah, I mean, the way this works is that you get a start form, there's a benefits investigation, and if there are policies in place, you can get drug pretty quickly. If policies are not in place, then it can take a little longer. Not everyone will get coverage, and at some point, you do an assessment on whether or not you provide free drug to someone. But I would say overall, as we discussed, access has been pretty good. Yeah, yeah, okay. Great. Any other questions on sort of the U.S. launch or anything else you guys specifically wanted to highlight on the U.S. launch? Go ahead, Jim. Yeah, one of the questions we sometimes get is the Symphony numbers that come out. So, yeah, we've been digging into those as well to try and sort of figure out what's going on there. A couple of things we know is obviously they're not getting the numbers out of the specialty pharmacy. They are tapping in, we believe, into the channel in a couple of different areas and then trying to sort of extrapolate from there. We know they're not covering all of the market, so we know it's a subset. And the algorithm seems to be a little bit off from what it's projecting. One of the things within that, as we've been able to deduce because we're talking to Symphony, is they appear to be counting the strengths. The 25, 75, 150 seems to trigger up. So, if you're going through titration, as you move through the strengths, it creates chatter in the noise. So, generally speaking, we just feel that it's not really projecting a really valid picture of where things are going because fundamentally, we still seem to, we're seeing new patients come in, and we're seeing the active patients number increase. So, that's our commentary on Symphony scripts, if it helps. Okay. No, that's really helpful. Makes sense. Great. Do you plan to pre-report at JP Morgan? Is that something that you guys are thinking about? We've been asked about it. Yeah. TBD? TBD. Okay. Great. Well, I think we can, it'd be great to kind of touch on EU. I think there's probably less relative attention there than there should be. It'd be great to kind of get your perspective on your confidence kind of ahead of a potential approval there and just kind of what that opportunity may look like. Yeah, the opportunity from a patients' numbers perspective is great. When you look at the EU4 plus the U.K., you see about 9,500 diagnosed patients. So, numerically, it makes sense. We have, as you know, we submitted the MAA, it was validated in May of this year. So, our projection is approximately a year from them for an approval decision. We received day 120 questions this quarter or last quarter, and we're working on the responses. Next step is for that submission and then what's called day 180 questions, which should come sort of late first quarter timeframe. Yep. Makes sense. And I know you've talked about historically there was some discussion with the EMA regulators around randomized withdrawal. Again, maybe that's kind of helpful context and sort of, again, informing your confidence kind of ahead of approval. Yeah. When we initially started discussing the program, we had proposed a six-month study both to the U.S. and the EU. The U.S. said, do a shorter study. The EMA said, do a longer study. And we had a conversation with the EMA about how it's impossible to do long-term randomized double-blind placebo-controlled studies and indications like PWS. And one of the mechanisms that they proposed at the time was to use strategies like randomized withdrawal to generate long-term control data. Now, obviously, our randomized withdrawal is not prospectively designed in that way, but we've ended up doing a randomized withdrawal, and the results have been pretty spectacular. So, our belief is that we should be able to prevail. The data set is the same as the U.S., in fact, probably more data given the long-term extension study. Yep, yep. Makes sense. Are you thinking about partnering in the EU at all? So, we are firmly on the fence on that one right now. There is a lot of interest in EU partnering. We are also equipped from a cash perspective to do it ourselves. We have done some high-level hiring in the EU already, and we are prepared to launch ourselves if we need to. But we should be making a decision on that in the relatively near future. Okay. Great. And then real quick, I know so Rhythm is going to have some data soon, presumably. Just curious your quick take on or perspective on kind of those data and just kind of maybe competition in general. Yeah, it'd be interesting to see the data. The only data we've seen from the Rhythm drug in PWS is a large randomized phase two study, which did not succeed. So, we're curious to see this data. I understand it's an open label study, phase two study. So, it's obviously non-registrational. So, if it's significant, perhaps they will have a program that will lead to approval a few years out at least. So, other than that, Ardvark obviously is running a study, which I understand will report out later in next year. And Acadia has failed. So, it remains, I would say, a fairly white space, blue sky situation for drugs in PWS. It's a big indication, a big unmet need, and space for others. Yeah, yeah. Makes sense. And maybe just in the last 30 seconds here, what do you think is next for Soleno? Do you think you guys are going to enlicense something over time? What do you kind of look at sort of the long-term future for Selena? Everything's on the table. I think it's fair to say we're very focused on the launch in the short term. But in the intermediate to long term, you will hear from us on organic as well as inorganic growth. Okay. Sounds good. Actually, last 10 seconds question for Jim. In terms of kind of spend going forward, anything notable kind of that may impact kind of the profitability trajectory? I think it's pretty straightforward. Obviously, profitable now, we intend to maintain profitability. We recognize that the real focus is growth in the VYKAT franchise. We'll continue to make judicious investments on the commercial side of that. A couple of things that will change the trajectory a little bit will be if we go Europe on our own, and that'll unfold in 2026. That may change the spend a little bit, and then ultimately the life cycle things through that. But well managed for where we are. Makes sense. Great. Well, I appreciate you both being here, and thanks everyone for listening in. Thanks, James. Thank you very much.