Good morning, everyone. Welcome to our third day of our 37th Piper Sandler Healthcare Conference. My name is Yasmeen Rahimi. I'm a senior biotech analyst here at Piper Sandler. Really thrilled to have the team from Soleno Therapeutics here, Anish and Jim, thank you for being here. Thank you for having us. Congrats on getting VYKAT XR approved, on track. You have had a strong, successful launch. So really, lots of kudos goes to you guys from the heart for your hard work on getting this drug to patients. So lots to cover. I guess the first question is, I think that when you reported the quarter, the number of patient forms had decreased when we went from 2Q into 3Q. Maybe, what do you see in the quarter right now to instill confidence that the VYKAT XR launch is continuing to be on track? Good question, Yaz, and I think the bottom line for us is that we don't see anything different in the business opportunity. We see this as a large, rare opportunity with nothing else available to treat hyperphagia and PWS. We see this as a business that's building steadily over time. As you've seen, we did 10% of our TAM, which is about 1,000 patients in the first six months, and as we've said, we think that if we can keep a cadence of doing another 10% in the next 9-12 months and repeating that, this is going to be a long-term, sustainable business. I will say that it's important to look at the entire universe of metrics and not just the start forms, so start forms is also the number of active patients. It's also the discontinuation rates. It's also the lives covered and its net revenue. If you look at all of that, I think this is a business that's doing really well. Okay, and Team, if you look at the current consensus as of December 1st, I think the expectations are for 4Q to be at $83.3 million, and then I think if you look at, maybe let's start there. Do you think it's a fair projection? I'll let Jim take that. Yes, well, so given that we're not giving revenue guidance, we're not going to comment specifically on the quarter. I do think, just back to Anish's comment, and I think the analysts who follow us have really identified this to be a very compelling and large commercial opportunity, so that aligns with our thinking. Team, if you look at sort of year 2026, I think it's projected VYKAT XR is going to do $463 million peak sales. I know you have your own expectations, right, for sort of where you want to be at maybe a year and a half, two years at launch. Help us understand if that's also a fair expectation to be already just really remarkable, right, in an orphan launch to be surrounded to $500 million peak sales? So again, without getting into revenue guidance, I think what we've looked at and we see in the models is, to your point, if you look at a few years, you see this definitely getting north of $1 billion. So we do think this is on a very exciting trajectory. Okay. Obviously, you guys have a really incredible pulse on how VYKAT XR launch is going. Maybe help us understand what trends you're observing, right, in terms of the prescriber base, the depth of the prescriptions, the repeat writers. Just give us sort of what you're seeing. Yeah, so to be successful, as you can imagine, needs to be deep in the KOL accounts, and it needs to be broad, because as we've indicated in the past, we see about 40% of the TAM, about 4,000 patients, either being prescribed to or influenced by about 300 healthcare providers, and the rest of it is sort of the long tail, so it's important for us to do both, and we are doing both. We've said that more than half of these top 300 accounts have written. Most have rewritten, and when you think about the long tail, we've had close to 500 prescribers in the first six months, which nobody thought was going to be possible, so we're continuing to do the work, and part of this involves things like inside sales, the virtual sales team, which we've been expanding. They're the ones who are doing the outreach. Okay. And Team, I think help us understand what is sort of start forms. I guess, what do you want to see in terms of start forms to feel confident in continued uptake? I think, obviously, the initial start forms were just patients who were super excited to get on VYKAT XR. Some docs had already started warehousing them. But what do you think is a reasonable cadence on a monthly basis or a quarterly basis? Yeah. So to go back to what we've indicated, we think that doing 10% of the TAM in 9-12 months is a very reasonable way to do this. But remember, you have to take all the other metrics with it. And we think it's not just the start forms, but look at the active patients, look at the number of people who are getting reimbursed, and you look at all the channels that we're getting payments through. So all of that, we think, is the right way to think of this. Okay. And maybe give us also a little bit of color on where you are in market access, right? Are you getting any pushbacks? Is there any denials? What frequency is that occurring, and what work are you doing? So that part of the story, I think, has gone really well also because 130+ million lives covered, payments coming through all channels, whether it's Medicaid, Medicare, or commercial, more than 40 states reimbursing on the Medicaid side, the three largest PBMs having favorable policies in place. All of these things are kind of extraordinary if you think about an indication where nothing had been approved until now. So we are really happy with where we are on the access side, and we see the story growing. A lot of it, I think, is related to the education that our team has done. And that started prior to approval. We had our team going out to various fairs, doing disease state awareness. And as you can imagine, it's not difficult for people to see that this is a disease that needs to be treated. Okay. Is there any improvements that are left to do? Given that you're, I mean, it seems like it's tracking well. Is there any modifications or room for improvement for 2026? I would say our work is stellar, and I think the cadence will continue. However, it's fair to point out there's always going to be some payer or the other or some state or the other which is going to have a problem, and so those things need to be worked through, but overall, we think it's going well. Okay. And then in the third quarter, you reported 1,043 starts, right, 10% of the TAM. How do you reconcile that 764 active patients you also reported? Yeah. So maybe I can help there, perhaps, and just explain how the flow works. So the start forms come in from, obviously, the prescribers. And they go into our, I think most folks know we have one specialty pharmacy hub that handles them. And so then they'll go through a little bit of making sure the forms filled out correctly, etc., etc., and some benefit analysis. There may be a small handful that get canceled, if you like, and don't make it through. But after the analysis, what'll happen is there'll be the first fill of the prescription. And so that basically turns it into what you might call the active drug. But that kind of takes time. We've said, think of it in 30 days, if you like, for a process. Each one, again, with small numbers, so it's a little bit all over the board. But let's say 30 days for a start form to work its way through. So there's always a little bit, if you like, in backlog. Then you get basically said to the prescription being filled. That turns, if we like to call it maybe gross active patients, because then there's the discontinuation rate that we've talked to. So that nets you down to the sustainable active patient number that you see. So that's how you walk it across. Then perhaps the other thing I'd throw in there is within that active patient number, you've got to remember that a portion of that is free and a portion of it is paid. And so that's basically how it breaks down. Okay. Helpful. Team, maybe another question is, and I don't think you've provided that, and I'm sure this is a metric will be, what is the refill rate at this point, and at what junction can you actually start communicating sort of? So you're right. We haven't given numbers around it, but I think it's fair to assume that the refill rate is strong if you look at our net revenue. So we think we need some more time to get to steady state, but I think it's a fair assumption to say it's a strong number. Okay. And Team, maybe help us understand free drug accessibility, how that's determined. Out of the 764 that are on active drug, how many of them are on free drug? And maybe explain to us how you determine sort of the eligibility of free drug, bridging them to getting a paid script. Right. So as Jim was indicating, a key part of triaging patients once you get a start form is doing a benefits assessment. So the physician who's prescribing the drug has an option to check a box that says quick start, which means wants to start this patient right away. So the benefits assessment in those cases is abbreviated, and they'll probably be put on drug quickly. It'll be a relatively small number, and they'll probably stay on free drug until the benefits assessment has been completed. And as you can imagine, majority of these cases, you will get them through to paid drug. The second category for free drug is bridge. So think of a clinical trial patient, for example, who we know is going to go on commercial regardless of what happens. You can bridge them until their assessment is done. And the third one, which is true free drug, is PAP. And that's usually a minority of the free drug. And these are people who we have assessed that they will never meet the criteria for getting reimbursed by anyone, so we want them on drugs. So all of these categories together at steady state in rare launches total about 20%. And people go sort of in and out of these. But right now, you're not in 20% because you said very small. We're low. That's correct. We're lower. Okay. At what point, I mean, the year is coming to an end. So a lot of clients are trying to figure out if you're contemplating to pre-announcing fourth quarter or even giving guidance for 2026. So how do you think about that? We prefer not to pre-announce, but we are contemplating. It's on the table. And as far as guidance is concerned, we need some more time to get to steady state. What are the challenges right now that presents itself to not give guidance? I think it's a lot of the components we've just talked about. It's the rate that it's all about rate. The rate the start form turns into a fill script. What is the proportion of free drug to paid at a stable basis, if you like? What is the stable gross to net? So these are things that we see trending into steady state, if you like. And so as we get the confidence that we're sort of approaching that, that gives us the confidence to be able to sort of give revenue guidance and make everybody's life a bit easier. Okay. And maybe the next bucket of questions are directed on physician education and awareness. Maybe, obviously, help us understand where you are in the process. I think on the last call, you guys highlighted how you started to really get the patient voice available to really share sort of the positive experience patients have with VYKAT XR. So help us understand what work has been done in terms of education of docs and the doc-to-doc communication. Yeah. This is obviously a big part of what our marketing teams do. It starts with disease state education. Obviously, if you're a KOL, you're familiar with the disease. You don't really need to be taught anything about it. But if you are one of many prescribers who don't have many patients with PWS, it's really important for you to understand hyperphagia, how it's taken care of, how do you diagnose it early, how do you treat it. So we have a lot of educational materials around that. There's webinars around that that KOLs have done for us. That's one. Two is peer-to-peer conversations. And these can take the form of events where a KOL will meet up with six or seven others, answer questions around dinner or whatever. Then the third is expert on demand. So the idea is that if you are a physician who's either not familiar with the prescription of VYKAT XR or has a question about it or has a specific question about a patient who's on VYKAT XR, you can literally pick up the phone and talk to an expert. And they will spend a half an hour with you. They're designated people who understand the drug, have used the drug extensively. So those are the key components of physician education. Okay, and how do you leverage the deep PWS-KOL network to influence these prescribing behavior of VYKAT XR adoption? So important. And as you can imagine, in any rare situation, you have certain KOLs who have a lot of experience, and there are others who learn from them. We are in this very interesting situation where it's a rare disease, but it's a very large rare disease. 10,000 patients, which is our TAM, 12,500 who are diagnosed. So while KOLs will treat a number of those, there'll be a number of those who will not go to the KOLs but be treated by someone else. And as I was mentioning, the peer-to-peer communications, the experts on demand are sort of more structured ways of doing it. But there's also other situations where a physician in the periphery will email a KOL or call a KOL and say, "I have such and so patient here, contemplating putting them on VYKAT XR. What do you think? How should I do this?" etc. There's a perception out among investors who think that, yes, you have a very great network of KOLs who have very vocally endorsed VYKAT XR, and given the strong launch, they wonder if those KOLs have already maximized their patient pool on VYKAT XR, and now it's more the focus of them to have, so could you maybe talk about, as you look at your network of experts, have they gotten to all their patients in their database and how much room is there left? So based on our conversations, our analysis, they have absolutely not. We believe that many of them have gone through a proportion of their patients. But as we have indicated in the past, our communications with them have been around the fact that their practices are packed. They can't just bring someone in and put them on VYKAT XR. They did some of that early on. But overall, we are now in a situation where these people will be offered VYKAT XRs if they come in for their typical visits. So a recent conversation with a KOL who has about 100+ patients suggested to us that 20%-30% of their patients are on, and they expect to put the rest or offer VYKAT XR to the rest as they come in over the next 6- 12 months. So we think that's typical of the situation. Okay. And maybe help us understand the key target. Who is the key target for the virtual sales team? And how are they focusing on which key physicians are of importance for them? So the virtual team is really targeting those physicians who in our claims data have, say, one or two or three patients. So it may or may not be worth it for an actual salesperson to go there, have a visit in person if the expected visit of the patient is months out. So we have our virtual sales team making these calls, trying to identify who these patients are. And we're using some pretty interesting ways to figure out when a patient might be visiting the doctor and targeting the actual sales rep to go in at that time. But the virtual teams are really targeting those who have very few patients. Okay, and of course, one of the questions that comes up is, is the sales team able to kind of help not only tell them about VYKAT XR and help them understand that there's accessibility to an expert network if they want to have more discussions, but what is the protocol by which they can help educate on sort of helping with how to titrate the close monitoring of the patients? Because I think if I step back and I look at maybe some of the learnings associated with some of the safety that was reported, it's maybe educating the docs on being more stringent, on more follow-up as needed, and staying on top as soon as a patient gets VYKAT XR. So, what is put in place once does the sales team cover those aspects? So the sales team, as you know, has to stick to the label. So they can have conversations around the label just based on what the label states. As you also know, when you want to go a step beyond that, we have MSLs. So we have a team of MSLs that is designed to address some of these deeper clinical type of issues. And that's at the physician end of things. And obviously, we have our clinical development teams who are physicians and in the company who also answer more detailed questions. And that's at the physician end. At the family caregiver end of things, we have our PACE team. So this is a team of nurse educators. The idea for them is to sort of be navigators for the family, talk about expectations of the drug, what titration should look like, what to expect in terms of side effects, if any, and what to do when those happen, etc. What is the normal sort of protocol if a patient is prescribed VYKAT XR? How soon are they recommended to visit their physician again, and at what frequency? So there's nothing that's defined in the label. And I think different physicians do it differently. I think it depends on their level of comfort. So if you're a physician who's prescribed it to 20, 30 people, you understand it, and you have a low-risk patient, maybe you don't need to see them very frequently. If you're a patient who is high risk because of comorbidities or other reasons, you might need to see them more frequently. Okay. And Team, I think we have heard, obviously, due to a short report, it's been shared always the negative feedback from patients. Help us understand, and these are isolated communications. So what is the current enthusiasm among patients for VYKAT XR? You recently implemented the Soleno PACE Program. Help us understand what does this program do. Lots of positive stories coming out. And we have a website, vykatxr.com, and we've started posting stories there. So it's expected to be updated on an ongoing basis. And it's really gratifying to hear the good stories. Small examples. For us, it may seem small, but someone posted just a couple of days ago, and this is a public post, something about the fact that so-and-so has been on VYKAT XR for four weeks. Today was their birthday, and for the first time ever, they said they were full. We have another patient who's an adult, lives in a group home in the Midwest. Parents who are quite old live in Florida. And one of their biggest challenges is going and getting this now adult to visit them, so they have to go fly there. And there have been times in the past when this patient tried to travel alone. Planes have had to be turned back because of their food-related behaviors. That patient is now able to travel alone and see their family. So lots of these things, which to us may not seem like a big deal, but we see kind of a groundswell of these stories now. A lot of that is being shared on and that we can access analysts and investors as well. It appears that analysts and investors have more access to information than we do. So yes. Yes. We would like to listen to some positive news. Definitely, we're all for it. No, that's very helpful. And you talked about, right, that you have nurses in place that can actually communicate with the patients. And just maybe just the frequencies of accessibility. Is this something like if a patient or a family emails the nurse, what is the turnaround time and communication and being there for them? It should be nearly real-time. If you need a PACE team member, firstly, you have to consent for them to contact you. But once you do consent, you should be hearing back. You should be hearing from them pretty much immediately, and they should be available to you. Okay. Perfect. And then how do you see sort of patients, caregivers, and KOLs all working together continue to get the positive voice of VYKAT XR? Yeah. I think the education piece is so important. And what we have seen is as you bring more people into the fold with the KOLs, as they get more comfortable prescribing, dealing with what happens when these patients, when they're hyperphagia, it's treated, etc. And when you have caregivers who are familiar with the story as well, it makes for sort of the ideal situation where people are able to stay on drug and do well on drugs. Okay. Now, next few minutes is just regulatory. I think a question we get is, obviously, the FAERS database is part of the process, part of every drug to be reported. Maybe help us understand how much insight does this really provide to see events, rates on VYKAT XR as it occurs? It's kind of a novel situation that we are dealing with, and everyone is. I think we happen to be in launch mode, which makes it a little more interesting for people. I think the important thing is to look at the language on the FAERS website. It says that simply the fact that something is listed there does not actually mean attribution to the drug and that these things are not verified. So anyone can submit information to the FAERS database, and the rigor of the information is not like a clinical trial-related database. So I think you have to be careful in how you interpret that data. As the events have occurred, has that impacted at all your regulatory discussion with the agency? Has there been any outreach from the agency to review? I think it's fair to say that the adverse events that we have seen have been within the label, so when you think about what we have said in the past, it's hypertrichosis. It is fluid retention-related adverse events as well as hyperglycemia-related adverse events, so that is sort of the universe of what we have seen. Okay, but there's not a regulatory implication based on it because these are event rates that were posted that are on label in the clinical studies. I think the regulatory process, the approval process has already happened. These are the adverse events that they have seen. We have said publicly that the rates that we are seeing things right now appears to be well within what we have seen in the clinical trial situation. Are there any analogs of specialty launches in the orphan indication that could help to support the regulatory implication or that the FDA recognizes there are all these nuances in regards to patient populations that are naturally at a higher risk due to many comorbidities? It's hard to point to a specific analog, but I think it's fair to say that the FDA, other regulators are familiar with the idea that there are certain populations that are at risk and have a lot of comorbidities, so when you're evaluating data, when you're looking at safety signals, you definitely put that as part of your equation, and I'm sure the regulators will do that. Okay, and then I think a question that always comes up is, what confidence did you have that these events that are being reported continue to be on label and in line with the actual history of PWS? It's the natural history of PWS as well as the known safety profile of the drug. Yes, what we have seen so far appears to be one or the other. Okay. And then maybe one last question is, I know you guys recently reported that Day 120 Questions were received by EMA. And maybe just give us an update where you are in terms of your regulatory filing in Europe. So yes, we received Day 120 Questions, and we're expecting to put the response in over the next few weeks. Great. Well, Team, it's been a pleasure having you. You have a very, very busy schedule ahead of you today, so let's thank Jim and Anish for their thoughtful discussions, and very excited for VYKAT XR's continued strong launch. Thank you very much. Thank you.