All right, perfect. Maybe I'll just kick this off, in the sake of time. Sure. Appreciate everyone—appreciate everyone joining, for this fireside chat with Alpha Cognition. We have Michael McFadden, the CEO of Alpha Cognition, ACOG, on the line here today, along with Boris Peaker, who is our Head of Research and Managing Director here at Titan Partners. This is a fireside chat format, so Boris has some pre-canned questions that he'll go through with Michael, but, with all the attendees on the line, please feel free to put any questions in the chat below. We want to make this as conversational as possible throughout the time here today. Boris, maybe with that, floor is yours, and Michael, and all the investors on the line here. Thanks for the time. All right, thanks, Jason. Michael, thanks for joining us. Happy to be here. Let's dive right in. Obviously, the investor focus is on the ZUNVEYL commercial adoption, and you've reported $2.3 million in sales in the third quarter. Can you remind us again on the key performance metrics that you're monitoring, the commercial launch, and what these metrics suggest about the total addressable market size? Yeah, so we look at, we're in the long-term care market, as a reminder to everyone. Long-term care is defined as nursing home or full care, entities that manage Alzheimer's patients. That market size is about a $2.2 billion market size. As we focus on the market, the KPIs that we look at are physician prescribing and repeat orders. We look at nursing home orders and nursing home repeat orders. Both KPIs are important for breadth and depth of the market. We also look at adherence rates, utilization of 10 mg versus 5, which is an indication of efficacy and tolerability. Then we look at payer metrics, plans covered, and all lives covered without restriction. Those are the primary KPIs that we're following and managing to at this point in time. Great. Let's dive into those just to kind of understand how those are evolving. We'll just take them in the order that you outlined them. Maybe let's start with the physician prescribing and repeat orders and the same kind of question on nursing homes and repeat orders. Where are we right now on those KPIs? Where do you see the target market is, and how do we get from here to there? Yeah, let me start with the nursing home. We target about 5,000 nursing homes. There are about 15,000 in the United States, 5,000 specialized in Alzheimer's, and they're outsized in the number of patients that reside in those, in those entities. We have about 600 homes that cumulatively have written prescriptions to date. Of note, about 550 homes wrote orders in Q3. We're seeing a 60% refill or reorder rate in the homes that we're calling on. We're going to see those numbers exponentially grow over the coming quarters as we reach more homes, homes feel comfortable with ZUNVEYL, and begin to utilize ZUNVEYL on its own. On HCP writers, we have about 3,000 medical directors, about 1,000 psychiatrists that we target, total about 4,000. We have about 576 writers in Q3, and cumulatively, we're approaching 700 writers since launch. About what we expected, but we'll see those numbers move into the four-digit numbers in 2026. We're also seeing with the prescribers, about 2/3 are repeating orders. To date, that number's a little bit lower than we'll see at steady state because many doctors are writing it for the first time in the quarter, so they haven't had a chance to write a second prescription. We'll see those numbers grow also over the coming quarters. Yeah. From a payer perspective, payers, we have a single payer contract right now. About 15% of their covered lives have come online. With that contract, we anticipate a second contract this month from another PBM, and we'll see the lives from that, that PBM manage, come online in the first two quarters of next year. Gotcha. What about the utilization? You mentioned about 10 mg versus 5 mg dose. Where are we at between those two doses, and how does you see that going forward? It's about 50/50 now. About 50% of patients are on a 5 mg, 50% are on 10 mg. It's about what we expected with the growth in prescriptions month over month. We should see, ultimately, at steady state, about 75% of patients on a 10 mg, and the remaining patients on either a 5 mg or 15 mg. It's an indication that the drug is really well tolerated, and that doctors are able to titrate it to an efficacious dose. Gotcha. In terms of pricing, remind us how the different pricing works for different doses. We have flatline pricing across all doses, and as a reminder, we took price in September. Our WAC price for all three doses is $820 WAC per month. Gotcha. With that WAC, how does the gross-to-net change? Gross-to-net this quarter will be about $600. And then at steady state, we anticipate gross-to-net to be about $500. When you say steady state, what is that, 2 years-3 years out, or? Yeah, about three years out. Yeah, as we have all, as we have a cohort of the payers that come online where we have contracts that have been initiated, and that'll take about three years total, we'll see that gross-to-net be about $500. Now, is there—I guess the question of why the specific timing of a price increase now, and do you see the opportunity for price increases kind of on an annual basis going forward, or some other schedule that makes the most sense? We felt like we had price increase opportunity here because it had, one, no impact on the payer contracts that we are about to bring forward, so we could be a little more aggressive on price. Number two, we had some market intel that basically said we could take price, and we've seen no impact from that price increase thus far. Third, we will encounter some impact from Medicaid, federal pricing, et cetera, in 2026. So we felt like it behooved us to take that price a bit earlier than we normally would have. On a go-forward basis, anticipate a 3% price increase on a yearly basis here forward. Gotcha. Do you think all of that is going to eventually work its—that 3% is going to work its way into the net price, or you think? Probably, yeah. Yes? Probably, probably 2/3 of it will work its way into net price. Gotcha. Okay, that's helpful. Maybe let's talk a little more broader about the—who are the key stakeholders in the prescribing decision, and what is the key message resonating with these stakeholders specifically? There are four key stakeholders. The first is a Medical Director. Medical Directors are assigned care, full care for the patients in a nursing home. They are usually an internal medicine doctor, primary care doctor, and they treat full patient care. They also treat Alzheimer's, most specifically the cognitive aspects of Alzheimer's for patients. They are our primary customer, and we call on these doctors every week, every day, in the nursing home. Number two, customer for us is the psychiatrist. They are a consultant Psychiatrist. Psychiatrists are called upon to treat the behaviors that manifest themselves as a symptom of Alzheimer's disease. These behaviors are things like aberrant motor behavior, agitation, anxiety, apathy. They are very common in Alzheimer's patients. In fact, 90% of Alzheimer's patients would have some behavior exhibit itself on a year, a year-over-year basis. The Psychiatrists treat the behaviors. We call on the Psychiatrists because we've observed that our product has very robust effects on the behaviors that are most common in Alzheimer's patients, and it falls in line with our indication. The third customer group that we call under the home itself, and that's typically Director of Nursing. They manage the care for the patients, and they're often the first to observe symptomatology in the home. We educate the nurses on our product. Last but not least is the Pharmacy, and specifically the Consultant Pharmacists, because they make treatment recommendations for Alzheimer's patients on a monthly basis. They review charts for every single patient in every home in the United States every month, and they are looking to make treatment recommendations to aid the doctors in their treatment of these patients. We call on the Consultant Pharmacists as well. Gotcha. Who were the kind of the initial adopters, and who are the kind of the more difficult group to reach over time or require a little more effort among these four stakeholders? I'll speak to two of the stakeholders. The Medical Directors that treat cognition, they have a very broad view of the Alzheimer's patient. The message aspects from the ZUNVEYL message that resonated with them are lower GI incidents with ZUNVEYL, no insomnia with ZUNVEYL versus other drugs in the category, which commonly have a 20%-30% incident rate of either of those side effects. That message resonates with them because they want patients to be able to tolerate their med well if they're going to use a drug to treat these types of patients. I think the other area of messaging that resonates with them is the cognitive effects and the dual MOA that ZUNVEYL has, because often patients that are treated typically with Aricept or donepezil as their primary drug lose efficacy or seem to lose efficacy. The doctors tell us over a matter of 2 quarters-3 quarters after initiation. They are looking for a drug that they can put the patient on that will have robust efficacy that they can dose to a therapeutic effect. They are a first customer. Those are the area of messaging that resonate with them. What we've discovered over the summer months, with the impact on behaviors with ZUNVEYL, is the psychiatrists are going to be a key customer for the company as we move forward. They are called in to treat the behaviors. There is high need to treat and high urgency to treat patients that are exhibiting these behaviors because the behaviors are so disruptive to the nursing home environment and the home, and often to the patient and/or their family. The Psychiatrists respond really well to the behavioral impact for ZUNVEYL, and its effect on—we use a, the scale NPI. It's a measurement that looks at behavior and drug response and behaviors with Alzheimer's disease. They have been very responsive to that behavioral element of ZUNVEYL therapy. The Pharmacists look more at polypharmacy and the impact of all drugs that may be used to treat an Alzheimer's patient, and how can they lower drug use. They respond really well to a drug that has no insomnia because they can remove potentially sleep meds from the patient's treatment protocol. They respond well to a drug that has low GI incidents because they can remove adjunct therapies that may be used to manage nausea, diarrhea, for a patient. They also are most interested in the behavioral treatment, just like the psychiatrists would be, because they are looking to reduce antipsychotic and psychotropic use, which is very common for other drugs in the category, to try to treat the behaviors, because those drugs have limited effect. Slightly different messaging with each of the customer groups, but those are the messages we've seen resonate really well. If we look at these patients, you know, assuming that the patients that started on treatment in 2025 are the initial adopters, what fraction of them are just totally new patients to this drug class versus maybe switching from Aricept? I would say almost all patients have been tried. 90% + patients have been tried on another therapy in this class. Very, very few new to treatment in the nursing home market. And almost all patients are on donepezil or Aricept. It has 70% + of the market, and most doctors use it as a first-line drug. We will often see patients being switched from Aricept to ZUNVEYL, and we anticipate that'll continue over the next few years that we're in the market. Is that primarily cost-driven just because Aricept is so much cheaper? It's primarily, well, it definitely there's a cost element. All drugs in the class are generic except ZUNVEYL. Doctors will use generic drugs, but they used Aricept as a mainstay product for 20 years. Some of it's historical. Number two, it's deemed the lesser of the problematic drugs in the class. The doctors will say it has less side effects than the other choices that they may have. They'll try to use the drug with the least amount of side effects. That said, they'll acknowledge that a third of patients have GI side effects on Aricept. 20%-30% have sleep difficulties or insomnia with Aricept. A large number of patients will lose efficacy over time. It's not a drug without issues. It just has less issues than the other choices that doctors may have. Got it. Let's maybe talk a little about distribution. How many distributors do you currently have? How many do you think you need to really penetrate this market? and also, as we think about these distributors coming online, how much of the sales is going into inventory build? Yeah. There are three primary distributors that have 90% of this market: Cencora, Cardinal Health, and McKesson are the three primaries. We have contracts with all, and they distribute our product. Every pharmacy in the country, every nursing home in the country has a way to get drug next day or even same day if they so choose. We will potentially add additional distributors next year. These would be specialty distributors that specialize in long-term care distribution or distributors that have a niche market for which we may have a robust presence in. We intend to add 3-5 additional distributors next year, and that'll give us 100% of market. Now, from an inventory build standpoint, the data is very, very choppy, and it probably will be for another two quarters, the next two quarters of our launch, because the wholesalers are trying to assess how much inventory they need, and we're growing at a rapid clip. It becomes difficult for them to make those assessments and figure out how much inventory they need to stock. We do see adjustments in inventory, both high and low, and have seen that over the last two quarters. We'll continue to see that over the next two quarters as well until we hit more of a normal predictable state for ZUNVEYL. Got it. Is there significant use outside of the nursing homes? Just curious if some of the distributors are seeing use there, and then if what the process of getting drugs there is, is it available at some pharmacies? Yeah, ZUNVEYL is available at any pharmacy in the country, but we see a very small minority of our use outside of long-term care. That is primarily because our salespeople are spending 100% of their time in the long-term care channel. We do have inbound requests for drug or requests on how to get ZUNVEYL. If a doctor chooses to do that, we help them. Any patient could pick the drug up at any pharmacy in the country. We would anticipate that will remain fairly small until we shift our salesforce attention to neurology, which would be our next submarket that we would enter. Got it. As we think about inventory build, just circling back on a prior question, if we look at, let's say, specifically in the 3Q numbers, do you have a sense out of the $2.3 million reported in ZUNVEYL sales in 3Q, what of that may be just inventory build from new distributors? Yeah, I don't think it was new distributors. I think it was existing distributors, and there was probably a 2 week -3 week inventory build, with one of those distributors. We anticipate that has washed through the channel as of this month, and inventory levels appear to be very normal. The caveat is it's still very choppy. As we accelerate in some markets, we see inventory numbers go up and down, and we'll continue to see that over the next two quarters. Got it. But in terms of dollar terms, what is a 2 week -3 week inventory build? I don't have a, I don't have a number on that, but I would say it was not material to the 2.3. Got it. Do you expect them to build some inventory before price increases going forward? If they can anticipate price increases, and that's what happened in September, they anticipated we were going to do something with price. They built some inventory ahead of that pricing increase. I think they will make, they'll be, they'll make speculative decisions on how they adjust their inventory on a go-forward basis, which is not unusual in the wholesaler channel. Got it. Let's talk a little bit about payer contracting. I mean, we touched on it a little bit, but I want to expand on it. Maybe how many covered lives do you have today, and how should, how is that expected to increase over the next, let's say, 12 months- 18 months? The Medicare D market, we're in the Part D, D as in dog, Part D coverage for ZUNVEYL. It's managed by four primary PBMs. There's Humana, CVS, CSI, Optum. They manage a ± 25% of the market. It's almost equal amounts of the market that each manages. We have one of those PBMs under contract today, and 15% of their lives have come online. We anticipate a second contract this month with a second PBM, and then we anticipate 25%-50% of that PBM's lives will come online within the first six months of next year. In 2026, we would anticipate a third contract, with the same corresponding percentages of lives coming online. That will give us critical mass in the market, allow the launch to inflect based on ease of use for physicians who want to prescribe ZUNVEYL. Got it. Is there a significant value in adding a fourth at that point, or three is? Three, three, three gives us critical mass for, for just adds to that. We'll, you know, we'll see what happens with the fourth PBM. It's not unusual to have three or four in the MedD marketplace, but we certainly will put a competitive offer in front of all the PBMs, and we hope to get, you know, three or four would allow the company to achieve what we've communicated, which is cash flow break even in 2027, with relative ease. Got it. Okay. That's helpful. Maybe let's talk a little about clinical development. Mm-hmm. Let's maybe start with the Converge and Beacon trial. What is, remind us what these trials are and what the objective is? Yeah. Converge is a really interesting trial. It's a retrospective data analysis of ZUNVEYL in the long-term care Alzheimer's market. It's an analysis of ZUNVEYL in this market to determine tolerability, dosing, polypharmacy impact, and efficacy. The reason this trial is important is it'll give us about 400 patients' data in the trial. The data set is used to publish in long-term care channels to long-term care audiences and will be used with payers to position ZUNVEYL appropriately in an area where there's very limited data, meaning long-term care has very limited data sets in long-term care. We're really excited about Converge and what that data can show us. Beacon is a real-world. Hold on. Let's just close the loop on Converge. Maybe I asked too broad a question initially. Sure. On the Converge, yeah, specifically, who is conducting this study and, what's the timeline for seeing the results? Yeah. We'll initiate the study in Q1. We're partnering with the teaching institution for the study. They have a pharmacoeconomic group that will manage the study data for the company in concert with our medical team here at Alpha Cognition. The study will initiate in Q1. We anticipate the study results will be completed in Q3, and top-line data will be provided in Q3 by the company. Correspondingly after that, we'll publish multiple data sets from that study that will enter the public domain and long-term care markets for multiple quarters after. What are the primary endpoints that you were looking at? We just want to understand what we should look at at some point once the data is published from our perspective. How do you think that resonates with the key stakeholders? Yeah. We'll look at tolerability, as a primary endpoint. We'll look at polypharmacy impact as a secondary endpoint, and we'll look at dosing and adherence rates also as a primary, all of which are really important for the long-term care marketplace, especially in the Alzheimer's class where adherence, adherence is an issue. Polypharmacy is a significant issue, and there's not been a lot of data on tolerability for this patient population. Got it. And is that something that's going to, I'm assuming, become the promotional literature going forward, for you guys? We will see what the data set results in, but we anticipate this will be used both with, in promotion with payers, with long-term care entities, and then from a medical-to-medical standpoint, by our medical team. Got it. Let's maybe go on to the Beacon trial. Yeah. Beacon is a real-world evidence study to determine the impact of ZUNVEYL in a long-term care setting. We'll be looking at cognition as a primary, behavioral results as a primary, and tolerability data, in 200 patients in the long-term care setting. We had planned to initiate that trial in Q1, and we'll complete the trial end of 2026. The significance of this data set, it provides 200 patients of data, with behavioral results and cognition results in the long-term care patient. For those of you who may not be as familiar with the long-term care marketplace, there's a dearth of data and data sets in the long-term care market. This will be one of the only data sets that will be published in the last few years in long-term care within the Alzheimer's space. We will use the data as a company, promotionally, to communicate ZUNVEYL tolerability, ZUNVEYL behavioral impact, ZUNVEYL cognition, and we'll use it with payers, PBMs and health plans for positioning of ZUNVEYL and why it should be considered a good formulary choice for their patient populations. If we contrast the two studies, Converge and Beacon, are they going to be largely similar? One is just retrospective, the other one is prospective, or is there, because both are in the long-term care setting? Converge, Converge, retrospective, Beacon, prospective, Beacon, Beacon providing behavioral assessment for patients by providers and treaters of drug. Converge, simply looking at retrospective data analysis in the long-term care setting across a variety of stakeholders and providers. Got it. Are there other studies to potentially benchmark the results of these trials in? Is there an Aricept equivalent to us for us to keep in mind? There's not really. There's been a dearth of data in the long-term care market over the last decade. There've been some study data looking at the meta-analysis data looking at behaviors, but it's all been in outpatient settings. That has been across multiple continents in the globe. There's not been really long-term care data to assess this particular patient population that we have seen. How do you see data being significantly different in the long-term care setting, let's say, outside versus the more traditional setting? The patients are, the patients are comorbid in the long-term care setting. They're, they're a sicker patient type. The institutional setting itself provides some uniqueness. These patients are also on a higher number of medicines that impact polypharmacy and the utilization of how physicians do and can treat the patient versus an outpatient setting. You'd have an earlier disease and a more healthy patient. Got it. Is compliance much higher in the nursing home setting than, let's say, in the home? Compliance is higher in the nursing home setting because medications are administered to the patient by a med tech on a daily basis. Yes, the adherence rate should be higher if the patient could tolerate the medicine. The issues in the nursing home market that would affect adherence are the patients just cannot tolerate the medicine, and they cannot tolerate the medicine either because the medication has side effects or it is interfering with other medications they may be on. The doctors have to adjust those medicines. Got it. Is there an opportunity to potentially work some of this data into the product label? Not from, not from Converge or Beacon. Those are not label-enabling studies. A third study we're doing called Resolve, we anticipate will be label-enabling. Yeah. We'll get to Resolve in a second. What about any kind of industry treatment guidelines or recommendations? What would Beacon and Converge be able to help with that? I think Beacon could be helpful in that, in terms of guidelines, because this is a therapeutic area where the drugs that exist outside of ZUNVEYL have very limited effectiveness in treatment of behaviors in the Alzheimer's patients. Most of the meta-analysis data that has been published indicates that donepezil and rivastigmine have modest to no effect in the treatment of behaviors with the Alzheimer's patient. If we can demonstrate, and we will demonstrate with Beacon, we believe that ZUNVEYL has a robust effect in the treatment of behaviors, that will be helpful, we believe, to psychiatrists who are treating and managing these behaviors and adjusting how they think about ZUNVEYL relative to a donepezil or rivastigmine for a patient with Alzheimer's disease who may be manifesting apathy, aberrant motor behavior, or agitation or anxiety. Which group sets these guidelines? There are multiple groups that set guidelines. The PALTmed has guidelines for treatment of Alzheimer's disease. The Alzheimer's Association has guidelines for the treatment of Alzheimer's disease. There is the Neurology Association, which also has treatment guidelines. Three major groups. Got it. Are any of them specifically focused on the nursing home settings or are they more general? PALTmed is specifically focused on nursing home setting and assisted living. Got it. How long does it take to revise those guidelines if you have data in hand? They're revised routinely, but there is not a, for PALTmed, there is not a specific timeline that is set where they update the guidelines on a routine basis. Got it. Once you have data in hand, the plan is to meet with these groups and see how to work forward. Yeah. More importantly, I think there's a plan from a company perspective to also talk with the health plans and the physicians that are using these treatments, to justify the use of ZUNVEYL in the treatment of these behaviors that, you know, manifest themselves commonly with Alzheimer's patients and would allow the physicians to justify why they're using ZUNVEYL versus other treatment options that they may have. Got it. Okay. That's helpful. Let's move on to the Resolve study you briefly touched on. Can you give us an overview of that trial? Yeah. Resolve is a phase four observational trial in Alzheimer's patients in an outpatient setting that will evaluate ZUNVEYL efficacy and tolerability in treating behaviors associated with mild to moderate Alzheimer's disease. It'll also assess caregiver burden in the outpatient setting and will assess multiple aspects of tolerability with these patients. The trial will enroll about 100 patients across the country and it'll initiate in Q1 of 2026. We think the trial will take about a year to enroll. The impact of this trial is it'll give us outpatient data and caregiver burden and ZUNVEYL impact on behaviors in the outpatient setting, which will be able to correspond compared to Beacon in the long-term care setting. We also believe the data for tolerability could be label-enabling from this trial, and certainly Resolve would be promotional for our sales team. Gotcha. This is a single-arm study, right? Single-arm, yeah. Got it. Have you had any discussion with the FDA what it would take to incorporate that into the label? We've had discussions with FDA, when our NDA was approved. We have some guidance, but not specifically to Resolve itself. Got it. Should we assume that if the data looks encouraging, there's a reasonable chance that it will be in the label or I don't know what the precedent is in this situation? Yeah. There is precedent for other phase IV observational studies to have data that is label-enabling. Certainly this fits within the FDA guidelines for promotion that we can, our sales team could use this data for promotion with physicians that we call on. I would, our assumption is that we will be able to add the tolerability data into label and we will be able to promote, our sales team will be able to promote data from Resolve in our sales efforts with practitioners. Got it. That's helpful. Maybe let's talk a little about the sublingual formulation. What is the objective of creating that formulation and where you are in that development? The sublingual is important because in the Alzheimer's category, about 20% of patients have aphasia or dysphagia, meaning they have difficulty or inability to swallow a tablet or a capsule. Today, those patients would be either given a patch formulation of rivastigmine, that is a patch that goes on the torso or arm of their body, because they have difficulty swallowing or cannot swallow, or the medication that they have is ground, if it's a tablet, or opened, if it's a capsule, and mixed with applesauce or some similar food, and they're given the product, their medicine that way. We believe a sublingual that dissolves on the tongue within seconds is much easier to deliver medication for this patient population. It's about a $200 million opportunity based on our assessment and the market, and it's highly prevalent in the long-term care area of the market. We are undergoing and involved right now in formulation and tasting work for the formulation that will take place through Q1. We plan to run a pharmacokinetic study versus our tablet and a third formulation, which is an intranasal formulation, on a pharmacokinetic basis. We believe that data, the pharmacokinetics will be similar and we would be able to file an IND for Alzheimer's disease for the sublingual based on that PK study. Gotcha. Our precedent is, our tablet formulation used similar PK data to file IND, versus the intranasal. We're taking that as that path forward with the sublingual. Got it. What would it take to actually get the sublingual approved? We believe the FDA will, based on feedback that we've had from the agency, the agency will allow the company to receive credit for previous phase I data that the company has completed, and we would be able to move to a pivotal trial versus the tablet, with our sublingual. We would move to pivotal trial, we believe in early 2027. What would a pivotal trial look like? It'd probably be a bioequivalence trial with a tolerability assessment, for the sublingual, but TBD based on FDA feedback on how we'll proceed with that formulation. Got it. Okay. That's something for 2027. Mm-hmm. For us to think about. Got it. You think it's a $200 million opportunity that right now is not being served in any way with the current formulation. They are not grinding up right now and putting it with applesauce. They are doing that. And it's just most difficult to do that on an everyday basis for a patient. It's, it's challenging to get them to take the medicine or swallow the applesauce. It's often bitter and the patients don't like it, so they resist. And the patch version of rivastigmine, which is the primary patch version that's used in this market, is very challenging to take as well. It has to be put on a new, new area of the torso or arm each day, and it has to be rotated over the course of about 30 days. Patients end up with these red dots all over their torso and their arms. It looks like a rash, and the patch often is irritating or agitating to the patient, so they'll pull it off in the middle of the day. Adherence is an issue, and administration of the patch is also an issue. We believe a sublingual that one would give to the patient, they put it on their tongue and it dissolves almost instantly, in a matter of seconds, would be highly preferable to the other alternatives that they have today. Has anybody tried to develop a sublingual donepezil? I mean, is there a history of that? Almost everyone has taken the path of a patch. Rivastigmine actually had great, great success with their patch. They initiated the patch not necessarily for patients with aphasia or dysphagia, but to try to bypass the GI tract and minimize GI side effects. That was their rationale. Novartis created, at peak, a $600 million brand with their patch by bringing that product to market. To my knowledge, I've not seen the sublingual or a film strip utilized in this category, which is surprising based on the large number of patients that can't swallow. The sublingual film strip, is that using existing technology or is this some, some kind of a new formulation that you guys came up with on your own? No, we're using existing formulation with a, with a entity that has multiple products that they have taken through R&D with their technology. And we'll release the technology at a later date. Got it. I'm just trying to think also that if this is approved, the sublingual would create a new chemical entity in some way or new intellectual property protection? We believe it'll create new IP, but that'll be dependent on the data that we generate from the work that we're doing over the first two quarters of next year. It could be a new chemical entity, but that'll depend on benzgalantamine circulation in the system. Not to get too technical here, but it could, but we don't believe that will be the case. We believe that it will not be a new chemical entity. Gotcha. Okay. Things. TBD, the pharmacokinetic data will tell us that. Got it. Speaking of different formulation, you're also working on a Namenda combo. Can you talk about that and the strategy around that and the development timing? Yeah. A lower, lower priority for the company, this would be a combination for severe Alzheimer's disease. Severe Alzheimer's disease, about 10% of the market. These are defined as patients who have no ADLs, you know, they can't assist themselves in any way. And often, for moderate to severe patients, Namenda is used as a combination drug to increase the MOA or add a second mechanism for the drug, in our case, a third mechanism, for the drug, primarily to try to get some additional cognitive improvement. We will, we're not moving this program forward at the moment. We'll assess and move that program forward after we have an inflection point with the sublingual. Gotcha. And lastly, in terms of various unusual studies that you guys are doing, you're also doing a bomb blast study with the Department of Defense. Can you speak on that or the relationship with the Department of Defense over time? Yeah. We've completed the study. We released data on the study. We hit all primary endpoints of the study. This is a bomb blast, small mammal study where they administer a bomb blast to the animal. The animal is treated with drug. An assessment is made for behavior, cognitive effects for the animal through a series of tests. Then we autopsy the animal after study and look at, we analyze the brain in the study to look at impact on p-Tau and amyloid and other impacts to the brain post-drug use and without drug use to see if there was a difference. What we saw was what we expected to see: impact on p-Tau, multiple p-Tau, no toxicity with drug, improvement in cognition and cognitive effects of drug, and a drug that's safe and well tolerated, which is determined by body weight of the animal. All good endpoints, achieved by the data set that we generated with DOD. We plan to meet with the Department of Defense on next steps in the next two months, and that will determine what path we have, or what interest there is to potentially take the product forward with the Department of Defense. How would this be even developed for human use? Or is it going to be some kind of an animal rule, development process? No, it's because it's the same compound and we have, it's, it's, it's Alpha-1062. We already have a huge body of evidence, toxicity studies, pharmacodiligence studies, ADME studies, human studies on the compound itself. So we already have a breadth of data that demonstrates a product's safe. The question for the Department of Defense will be, is the product and can the product be effective and is it effective at what dose? And can the product be administered in a way that aligns with the needs of the soldier in theater who could be bomb blasted or who could be given a moderate or mild concussion that would preclude them from performing on the battlefield or performing in theater. There are some questions from an administration standpoint that the Department of Defense will need to answer, will need to answer as a company. Next steps are likely. We met with FDA on the program. Next steps are likely for this program, a 12-week tox study. We have two 28-day studies. We would run a 12-week tox study to demonstrate no toxicity in large mammal. We believe we have the data package to submit an IND for cognitive impairment with mild traumatic brain injury with that compound. We believe the FDA will give us credit for the two phase one studies we have with a different formulation, allow us to move to a phase two efficacy trial. We have completed phase one studies with an intranasal version of this compound. It demonstrated no toxicity, demonstrated effective dose. We believe we'll be able to do that with our sublingual formulation, based on feedback that we've already had with the agency in a pre-IND meeting. The goal is to develop it for patients with traumatic brain injury for recovery or? The goal, the goal would be the regulatory path forward that we believe is, the path that we want to take for the compound is for cognitive impairment with mild traumatic brain injury. That is assessed three months post-concussion. It is not acute, but it is assessed three months post-concussion. Most patients with concussion, or about half of patients with concussion, it resolves on its own. At three months, the placebo effect has washed out and the data clearly shows what a patient has, they are stuck with that, that remains with the patient over the next year of time. We would be looking at patients who have not resolved on their own, administering drug and determining if the cognitive impairment symptomatology resolves with active drug treatment. Got it. Let's switch back to some commercial discussions. Maybe let's talk a little bit about XUS strategy. Please discuss your partnership and the strategy in Asia. How should we be thinking about pricing and just commercial value in China and market size there? Yeah. The market size in China is about 10 million patients. About 8 million of those patients have mild to moderate Alzheimer's disease. It is a large market. They have an intensifying aging trend. Those numbers of patients are expected to grow significantly over the coming decade. The pricing has not been determined in China, but as one could expect, the pricing in China would be similar to other Asian and European countries, which would be a lower price point than the United States, but it is still to be determined on what the pricing is going to be for ZUNVEYL if approved by the Chinese regulatory authorities. We submitted in China and our file was accepted in July and that triggered an 18-month clock, which would correspond with a late 2026 approval. Gotcha. What should we expect, in terms of the economics to you guys, versus your partner? Yeah. We have milestone payments, based on approval and sales milestones that would occur in all Asian countries where the product would be commercialized. Then we have a high single-digit royalty from that agreement. We do not know what the economics are yet and will not know that until price is determined in each of the markets in which the product is approved. We expect three of those in 2026, three small markets followed by China, which is the large market opportunity for the company. You do not have any costs in terms of marketing or launching the drug in China. You are just collecting milestones and royalties. Is that correct? You're correct. Got it. Okay. We should start to see some potentially milestones and royalties start coming in in 2026. In 2026. Correct. In 2026. Okay. Let's talk a little about your financials. You guided to operating profitability in 2027. Can you explain what does that mean? What's included in this? What's excluded? Does that mean you can have a GAAP profitable for Q2 2027 or help us understand what that means? Yeah. So it includes SG&A and R&D, for operating profitability. We exclude non-cash items like depreciation, amortization. Those are not included in our calculation. So operating profitability in 2027. That's for the entire year, not just hitting it in one quarter. Correct. Gotcha. Can you share with us what, what revenue needs to be in 2027 in order to do that? Or maybe flipping that around is how we should be thinking about SG&A or R&D. Yeah. Yeah. I'll share on the expense side because we're not providing revenue guidance. In 2026, we anticipate we'll spend in the range of $50 million-$55 million for the year. We think that'll be consistent, consistent, but maybe a little bit lower in 2027 because we won't have the clinical studies that will be ongoing at, in 2027 that will be ongoing in 2026. By that, I mean Beacon, Resolve, and Converge. Got it. Okay. That's helpful, to think about exactly. Should we see a significant increase in just sales and marketing spend going up next year or is that where the most investment's going to be? Yeah. That's where most investment's going to be. We have, I think we stated publicly that we are increasing our sales force size in 2026. That's well underway. We'll have a sales force of 50. We've increased our reimbursement team to manage the payer issues, and we're exploiting the psychiatry opportunity for symptomatology with behaviors that occurs in Alzheimer's patients by increasing our marketing spend to the psychiatrist, increasing our meeting presence where psychiatrists often meet, and increasing our publication strategy geared toward the psychiatry community, because we believe it's such a great opportunity for the company. You'll see some expenditure increases in all those areas in 2026 to take advantage of the opportunity. Got it. 2026 is going to be kind of a peak year, you said, for R&D and the decline just because the number of your studies is going to be winding down? It'll decline on the basis of a Resolve, Converge, and Beacon. We don't know yet what the FDA is going to allow us to do or what the path on the pipeline assets will be. TBD on what the spend is going to be for the R&D program for Alzheimer's disease for sublingual, and the R&D program will be for mild traumatic brain injury. Those are not included in our calculation on R&D spend for 2027. Got it. If those move into further development, that could then increase R&D spend in 2027. You're correct. Yeah. We're assuming that's going to have a positive ROI going forward. Yeah. Yeah. Makes sense. Let's also real quickly, in terms of the second tranche payment from your partner CMS, when should we be expecting to see that? Both on a cash and accrual basis. Yeah. We expect to see that this year. We're at the mercy of Chinese regulatory authorities for that payment to be submitted to the company. If the Chinese regulatory authorities don't meet their own timeline, that could delay into Q1 of next year. We're at the mercy of the regulatory authorities for that payment to be received by the company. The difference is really just either this quarter or the next quarter. Yeah. Based on the feedback we've had with the Chinese regulatory authorities, yes. How good are they generally at keeping that timeline? You have an official PDUFA like we do, right? I do not know exactly how to think about them. Yeah. They provide guidance. I won't comment on whether they meet their timelines routinely or not because this is our first entree with the regulatory authorities. They have a timeline. We're well within that timeline at the end of the year. Sometimes regulatory authorities need additional time to assess and they could certainly take that. It's their privilege to take that if they so choose. Got it. Okay. That's helpful. I guess maybe in the last couple of minutes, we've kind of gone through the key questions I wanted to ask. If maybe you could summarize the key catalysts, from the clinical development and anything else kind of relevant to the investor perspective in the next 12 months- 18 months? I think this is a commercialization story. I hear this often from our investment community, and everyone wants to see the inflection point from ZUNVEYL commercialization in the U.S. I think that's the thing to be looking for in 2026, and we should see inflection in 2026 from our commercialization activity. That will be something that I think carries the company forward as we execute from a data perspective. Which quarter do you want to? Yeah, I think it'll be the first half of the year that we'll be in the market a year in the second quarter. We should have some of the payer friction points removed in the second quarter. We anticipate we're going to see some inflection in that, in the second quarter of next year. That would make sense with the payer contracts that we have going into place in Q4 of this year and the one that we had in place in July of 2025. I think that's something to watch. I think the Beacon study provides a great moat for the company and treatment of behaviors. It will certainly strengthen our position with payers and then Resolve could be label enabling data for the company. We won't have that data until 2027, but we will have an interim analysis in the third quarter of 2026. That's something that investors should look for. We've been making great progress with our Asian partners, so we should see multiple country approvals in 2026, and those will begin to add some revenues to the company. The other thing is the IND for Alzheimer's disease with our sublingual. We should have feedback from the agency in 2026 on that program. That could be significant because the opportunity is significant at a $200 million + opportunity with sublingual. Great. That is a lot of things to look forward to over the next year. Michael, I appreciate your time. This was an interesting discussion, and we look forward to seeing your progress. Thank you, Boris. I appreciate the time, and thanks all for everyone for listening and your interest in the company.