Alpha Cognition Inc. (ACOG)
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Investor Update

Jan 28, 2025

Speaker 4

Good afternoon, everyone, and welcome to today's call where we will be discussing Alpha Cognition's commercial launch strategy for ZUNVEYL, an FDA-approved treatment for mild to moderate Alzheimer's disease. Before we begin, please note this presentation contains certain statements that reflect current views and expectations of Alpha Cognition with respect to its business and future events, including statements regarding the company's commercial plans and strategies for ZUNVEYL. These are based on current expectations, beliefs, assumptions, estimates, and forecasts about the company's Alzheimer's disease treatment landscape and the markets in which it operates, particularly the care market in the U.S. and abroad. Investors are cautioned that all forward-looking statements involve risks and uncertainties. No assurance that forward-looking information or the material factors or assumptions used to develop such forward-looking information are accurate.

We make no obligation to release publicly any updates or revisions to any voluntary statements found in the company's securities filings. Now, it would be my pleasure to turn the call over to Michael McFadden, Chief Executive Officer of Alpha Cognition.

Michael McFadden
CEO, Alpha Cognition

Thank you, Robert. Thanks, everybody, for joining this afternoon. We're really excited to update you on Alpha Cognition's commercial progress and to give you the opportunity to hear from two experts in the long-term care treatment arena today. I'll introduce them shortly. As a reminder for everyone, we have our approved product, ZUNVEYL. It's indicated for the treatment of mild to moderate Alzheimer's. So we have a broad label indication, the product was approved by FDA in July, and we plan to initiate commercialization in March of this year. The market's a large market, the 11 million prescription market. However, this is a market that's characterized by high dissatisfaction with almost all stakeholders that treat or manage Alzheimer's disease. It's also an area that's characterized by high discontinuation.

In fact, one out of two patients who take one of the agents in this therapeutic class will discontinue that drug the first year. Now, we believe ZUNVEYL has been designed to minimize some of the treatment-limiting side effects that occur with other drugs, and we also know that we'll have some of the best outcomes data to utilize in our commercialization activities as we launch ZUNVEYL. Our initial launch strategy is to launch into the long-term care segment of the market. That's a $2 billion opportunity for the company, and Lauren will speak more detailed on our launch strategy and some of the tactics we plan to execute. I will update the group, though, on the overall company goals for 2025 and what we expect to accomplish the remainder of this year. First, I'll start with the commercial launch.

The most important thing this company will do over the course of the next 12 months is to launch ZUNVEYL successfully into the long-term care segment. So we plan to do that with a commercial team. Lauren will speak to that, as I mentioned, in a few moments. But I'll speak to the support that undergirds that commercial team and our progress to date. The company's hired operational, legal, compliance, pharmacovigilance, safety, and sales leadership roles, all of which will support our customer-facing team and the infrastructure of this launch. We've done that on time, and we've done that on budget to date. Secondly, our manufacturing process is proceeding according to plan. We just had product roll off the line yesterday, and our manufacturing is going on time and also on budget to date. We plan to have product in the sales channel the third week in March.

The company's also committed to manage our expenditures in 2025 very diligently to make sure that we can move this company to break-even status in three years. Now, to have a successful launch, you have to have medical support and medical information that supports the product. And we aggressively will submit seven abstracts and/or publications or manuscripts for publication this year in 2025. So you'll begin to see some of the information on ZUNVEYL the latter part of this year, early next year, and that will support our launch. The company also plans to initiate one phase IV study, which will strengthen the dataset for ZUNVEYL. We'll announce more details as that study is underway. Third, from a business development standpoint, we've completed this year our first ex-U.S. deal. We completed a deal with CMS Pharma, which is a Hong Kong-based, fully integrated pharmaceutical company.

They have a very strong focus on neuroscience conditions. We're excited about the deal. It provides $6 million in early-stage payments for the company. It will also provide an additional $38 million in sales and regulatory milestones as we progress the asset in Asia. The company will also receive high single-digit royalties when the product's commercialized. And we believe this deal not only will provide additional capital for the company, it's also going to provide additional data to support ZUNVEYL. And it provides certainly strong evidence that we can conduct deals ex-U.S.. In fact, we plan to pursue an additional deal this year. We think we can close another deal ex-U.S. before end of year, which will provide additional capital and also royalties for the company. And last, from a company focus, we plan to advance our pipeline. Let me speak to that.

So we plan to use our business development dollars to advance our sublingual formulation for mild to moderate Alzheimer's disease. We plan to complete formulation work in 2025 and also to complete pharmacokinetic studies for that compound. The significance of this is if those pharmacokinetic studies demonstrate comparability with our intranasal formulation, we should be able to leverage already existing toxicity, pharmacokinetic, ADME, and phase I study data for that program. So we could move rapidly, assuming that data demonstrates positive results for the company. We also plan to complete an FDA meeting for our late-stage combination asset for moderate to severe Alzheimer's disease. The purpose of the meeting will be to align with the FDA on next steps for the program. And then lastly, we plan to complete a proof of concept study for acute pancreatitis.

If our pharmacokinetic studies demonstrate good data and our proof of concept study data demonstrates positive endpoints, we think this could provide a path to an IND for this condition. So a lot going on with the company. But let me reiterate, the most important and key focus for the company is to have a successful commercial launch and operationalize ZUNVEYL in the commercial marketplace. Now, let me introduce our speakers for the day. I'm going to introduce them all at once, and then they'll hand off to each other as the program progresses. First, I'll introduce Cathy Parker. Really excited to have Cathy with us today. She's Vice President of Outcomes Centered Healthcare at Eventus. Now, for those of you who don't know, Eventus, it's one of the country's leading providers of in-person value-based primary care and behavioral health services for people residing in long-term care.

It's a multi-state company that has many employees and hundreds of nursing homes that they manage. Cathy previously served as Director of Value-Based Care for this organization. She was a co-founder of Extended Care Specialists, one of the largest long-term care provider organizations in Indiana. She's a registered nurse, nurse practitioner, has 20 years' experience both caring for patients and leading teams. We're excited to have Cathy. After she speaks, Dr. Hany Mohamed will speak. He's the Director of Clinical Services for LI Script. Now, he brings 20 years' experience both in pharmacy expertise retail and pharmacy expertise long-term care. So, breadth of experience in pharmacy. Dr. Mohamed's board-certified in geriatric pharmacy. He's board-certified in medication therapy management. He serves as a consultant for many companies in the pharmaceutical and biopharmaceutical segment.

So he has a breadth of experience that he'll be able to share both in how our product fits in the marketplace, and then just the role of a consultant pharmacist in an operational pharmacy and what difference does that make for a pharmaceutical company like ours. And then lastly, many of you know Lauren D'Angelo, our COO. Lauren brings a breadth of experience in commercialization. She'll speak to the specifics of our commercialization strategy. This will be her 16th launch, by the way. She's 15 launches, 20 years' experience. I always say we're fortunate to have Lauren, one of the best marketers in the industry. She'll wrap our program. Then we'll turn it over to you for questions you may have for the group. So without further ado, let me turn it over to Cathy. Cathy?

Cathy Parker
VP of Outcomes Centered Healthcare, Eventus

Thank you, Michael. I wanted to just start off by talking about why it matters to treat Alzheimer's disease in the nursing home. In my experience, the majority of residents in nursing homes have some issues with cognition. About 70% of the patients in long-term care have Alzheimer's disease or related dementia. The reason they end up in the nursing home is because they have cognitive impairment where they're not able to live at home safely. Maybe they're wandering or they just need more help throughout the day with their activities of daily living, which means feeding themselves, cooking for themselves, grooming themselves, etc. They end up in a long-term care setting. Really, treatment of Alzheimer's dementia. There's a clinical perspective and also a business perspective that folks may not really realize. This is a devastating disease.

My own grandmother had Alzheimer's disease, and she had played the organ in our church for 50 years and lived with my grandfather. They were married over 70 years, and as her dementia progressed, she wasn't able to stay in her home safely. She was wandering at night, but this is a devastating disease where if it's not treated, the progression can be very rapid. There's a cognitive decline where memory loss is more rapid. There's increased risk of death earlier. Behavioral issues can occur, like in my grandmother's situation. She started cursing and becoming agitated, and she was the most gentle, humble soul there ever was. A lot of these folks are wandering. Their risk of falling doubles. They have issues sometimes swallowing. They have a hard time getting their words out.

And just, again, those activities of daily living, of dressing themselves, showering themselves, feeding themselves, all those things decline. And if it's untreated, this happens at a very rapid pace, which can be just very concerning and difficult for the family members as well as the patients themselves. So there's a clinical approach, but there's also a business approach. And for the buildings, the nursing homes, for those folks that have dementia, there are situations where they look at star ratings, where these are results that are published online for the public to see. And these star ratings look at basically the results of the number of wounds in a nursing home, sleep issues, the number of falls, urinary tract infections, the percentage of antipsychotic medications, and then also the management of the patients and their ability to remain independent.

So you may not look at it from a nursing home perspective, but if a nursing home has poor star ratings because they have bad measures in these categories, those results are published online, which can affect subsequent referrals. So there are current approaches to Alzheimer's disease management, and it really is a team approach. We have the pharmacological aspect of it, also the psychosocial aspect of it, where we look to have the social workers, the nursing staff, families, caregivers that are really kind of helping manage the disease management over the course of the disease. So really, we try to identify shared goals and try to minimize that progression and then adapt as the issues of dementia progress over the years. So as someone becomes more confused or has swallowing difficulties, issues with sleep, and we personalize that treatment plan.

And then oftentimes, the patient isn't able to tolerate medications that they're on, and we have to adapt with our treatments to manage those side effects or adverse effects of medication. So we have several current treatment options. Right now, the first line recommendation is the acetylcholinesterase inhibitors. However, like Michael mentioned at the beginning of his part, one out of two patients can't tolerate these medications. So very high discontinuation rate due to side effects. And as you look at this list of four medications, you'll see that a common theme is GI side effects. So I've seen this over and over again clinically. In fact, I had one patient who could not tolerate medications. And some of the things that happen are the folks have nausea and diarrhea, which can subsequently cause weight loss.

And so I had a resident that had moved in newly to the nursing home, and they'd lost over 30-some pounds in the last year. And after I was talking with the family, they gave me history that this person had been referred to a gastroenterologist, worked up with a colonoscopy. And obviously, this person became weaker, was falling at home, still having diarrhea, and the family couldn't care for him. Well, after getting a thorough history, I realized this person was on donepezil, and it had started about a year ago. And obviously, this patient had a side effect of diarrhea, and it had gone on for over a year and caused significant weight loss. So once we ended up getting that patient off the donepezil, their diarrhea stopped. They started gaining weight again, but unfortunately, their progression with dementia did rapidly continue.

Another side effect we see that's a common theme is insomnia. So if you pair this with someone who's confused and wandering and up at night, it's really a recipe for disaster of them wandering outside their home or wandering around other units and other patients' rooms in the nursing home. So that also can be troubling and concerning. It's also a side effect for the second medication listed, the rivastigmine. The nice thing about this medication, even though there's moderate outcomes data with it, is that it's a patch. But oftentimes, these folks that are confused will take the patches off. So compliance, you may think a patch helps with compliance, but if they're confused and they don't understand why something's on their skin, they'll pick this off. It can also cause a high rate of skin irritation. These people have very thin, fragile skin as they age.

So oftentimes, we see rashes, and the tolerance to this medication also can be very low as well. It can still cause some GI side effects even in the patch form. And again, that insomnia can also be a problem. We've got galantamine, which is once or twice daily dosing. This has the strongest outcomes data. But again, we run into that same thing with GI side effects. And then the memantine is the last one, which is actually an add-on therapy, but it has some marginal efficacy and can cause some dizziness. So again, paired with that, with someone who's confused, can increase their risk for falls. We also have to watch out for those folks with kidney issues because we have to dose adjust.

So what I typically find in long-term care, especially, is folks come in and they haven't been able to tolerate medications, or maybe they're on a lower dose of these medications, and they haven't been able to reach optimum therapy. And so we really haven't been able to maximize limiting their disease progression. So this is why I'm excited about a product like ZUNVEYL. We have talked recently about the GI side effects and how it could be limiting for patients that we're trying to slow the progression of their dementia. So now that we're going to have an option where those folks, one out of two that haven't been able to tolerate it, and even the ones that have tolerated it, a lot of those folks, we can't get to maximum dose because of those GI side effects or the insomnia.

So I'm excited about a product where really the tolerance can be greater. And it's really another tool in our toolbox to give hope to families, also to patients of slowing that progression. So again, proper treatment with the less side effects, I'll be able to maximize treatment and reduce cognitive decline along with their mortality risk and minimize risk of skin breakdown. If folks have diarrhea, they're going to be more likely to have skin breakdown on their backside or be prone to urinary tract infections or dehydration and weight loss and falls. So again, from an operational standpoint, from the nursing home, they're going to like this because their star ratings are going to be improved with less fall risk, less weight loss, again, less wounds, all those quality measures that are built into those star ratings that they're judged on by CMS.

So again, I'm excited again about having minimization of those GI issues. Another aspect with the nursing home is these buildings are really working short-staffed. So if you have CNAs and nurses that are trying to give meds to 40 people and you've got folks that have diarrhea, that's a lot of staff time trying to manage those folks and help them with activities of daily living. So if we can improve their diarrhea symptoms, their GI symptoms, their insomnia, and also lessen the risk of falls and wounds, that's going to help, especially with the staff burden that they're already challenged with. So in summary, I'm excited about a new product that we're going to be able to help slow the progression with dementia.

It'll be proven for that and also minimize the GI side effects and insomnia where current treatments are not helpful or have that risk for.

Hany Mohamed
Director of Clinical Services, LI Script

Thank you, Catherine, so much. So I'm curious to talk a little bit about how pharmacists play a role in the LTC setting. And they have two major roles that they play. One can be an operational pharmacist or a vendor pharmacist, and the other one is consultant pharmacist. And before I get into their responsibilities, I just want to kind of let you know the differences between what happens in the community and what happens in a long-term care facility when it comes to our residents. Remember, these residents don't have a choice of what pharmacy that dispenses their meds to or what physician kind of sees their patients. So in LTC, the operational pharmacists and the consultant pharmacists are pretty much contracted with the facilities, and they have a little bit more leverage and impact in optimizing medication therapy.

In the operational pharmacy, pretty much they're responsible for purchasing and dispensing their medication to our residents, doing high clinical assessments called drug utilization reviews, where they check for allergies and they check for duplicate therapy, etc., and resolving third-party payer insurance coverage issues and helping the facilities getting branded drugs covered, which can, where the benefit most likely outweighs the risk for other alternative medications for that patient's condition. On the consultant side, they do individual monthly charts for medication reviews. They also do medication therapy management, make sure the meds kind of match the diagnosis, and they're looking for unnecessary medication or medications being used to resolve other side effects of other medications and make recommendations to ensure optimization for medication.

And they also educate the interdisciplinary team at the facilities to kind of help them with their quality assurance, quality improvement, get them ready for audits. And the main thing is ensuring medication safety and efficacy on both sides. Okay. So what's the flow? What happens when a patient gets admitted or gets readmitted into our facility? Well, the operational side gets to see the resident first. Remember, these residents coming from the hospital or clinical community, they actually come in with no medication. They cannot bring the medication from the hospital, nor can they bring their medication from the facility. So the vendor pharmacists have to do a very thorough analysis on duplication, drug-to-drug interactions, and allergies, and try to get coverage for a continuation of therapy. And this transition of care coming from the hospital, coming from the community causes a great disruption in assessment.

We're trying to a lot of these hospitalizations, rehospitalizations are very preventable. Of course, the elderly of the geriatric population, specialized officers are highly susceptible to these going back and forth into the hospital due to physiological factors because of their age and chronic comorbid conditions can result from it. On the consulting side, they have to come and review these resident charts every 30 days. It's actually federally mandated. It's a law brought down by CMS, Centers for Medicare & Medicaid Services, to actually review a chart when a patient comes in with 30 days. And thereafter, and also, it's mandated on the facility side to put protocols and regulations for that to actually happen. And what consultant pharmacists are actually looking for is drug-diagnosis mismatch. They're trying to reduce medication, looking for unnecessary medications or medications that can actually cause side effects, and they add on.

I've seen a lot of times a patient can be continuing the most popular Alzheimer's medication called donepezil. And along the lines in the facility, they develop something called insomnia, and then they add on a hypnotic. And this is where consultant pharmacists can come in and actually recommend changing it to a more safer maintenance medication for their dementia medication to not only help the resident with the Alzheimer's dementia, but also discontinue that hypnotic that might cause more risk than benefit. And also, they're more proactive in their analysis where they're looking for potential weight gain. They're looking for increased risk of ulcers. They're looking for other patients actually improving in their ADLs, such as walking, eating, dressing, bathing. So this is all medication-related therapy that can help be improved by both entities and the recommendation of the expertise in the geriatric population.

So we kind of leave the heavy load when it comes to diagnosing and assessment, obviously, to the medical staff and the nursing staff. But we definitely hold hands together. One thing I learned in pharmacy school is the provider, the pharmacy, and the resident, if the collaboration is not strong, all fails. So our goal is to obviously optimize efficacy and minimize safety. And especially with the consultants, when they go into facilities, we want to make sure that administration of medication, the formulations of the medication is actually adaptable to our residents and how their conditions are presented to be. So seeing if they're taking it one or two times a day or taking it with food, helping out our nursing staff because there are our eyes and ears to our residents.

I mean, Cathy kind of touched upon this, but I mean, I see this very common in our facilities. You see the limited amount of options that us pharmacists have in recommending or continuing therapy for Alzheimer's dementia. A lot of our residents definitely have sleep disturbances and insomnia, GI side effects for most of them, nausea, vomiting, diarrhea, GI upset. And then, as Cathy mentioned with the rivastigmine patches, they'll face skin issues. And a lot of these residents kind of just either stop their medication. It's not effective, or they're actually refusing the medication when the nursing staff is administering to them.

We get a lot of calls on the vendor side where the nurse has said, or nursing is telling us, "Listen, can you tell us any other options we can give because my patient keeps refusing it, refusing the maintenance medication?" And that, in turn, can obviously have more rapid kind of decline due to decrease in adherence and compliance. As a pharmacist, we always want to hear medication that can help, are more tolerable and increase adherence and compliance. The risk of polypharmacy, adding on a medication to treat side effects of the maintenance medication due to behavior issues. Also, the risk of the need to use restraints. That's something we don't want happening to our residents in the facility. Decreased quality of life and functional capacity.

And then that can also intensify the burden of our nursing staff who's helping us, again, our eyes and ears and telling us the symptoms and the progress of our patients. And that, taking it to another level, the reputation of our LTC facilities when it comes to their quality measures, which kind of affects our facilities measure because of the risk of hospitalization, rehospitalization, and keeping the facilities competitive. So speaking of quality measures, about a third of our long-stay quality measures are either directly or indirectly related to medication use. And like I mentioned earlier, a lot of these residents don't have a lot of choices. They're just continuing therapy and tolerating and putting other medications to subside the side effects, or they're just refusing the medication and just stop taking them. So a lot of potential negative outcomes can be happening.

As you can see in the middle column here with medication-related use, especially ones that are continuing therapy with the insomnia, the GI upset, the nausea, vomiting, the diarrhea. The possible negative results that can happen from that is falls, dizziness, dehydration, weight loss. Then the facilities get dinged on a quality measure side with the rates of hospitalization, rehospitalization, the rates of these patients, increased risk of injury, infection, and also affecting their functional daily living with their walking and eating. Then those who are being untreated or refuse medication, they develop somnolence, dizziness, and obviously can have more rapid cognitive decline and can develop into agitation or even psychosis. Those can increase the risk of falls and fractures and quality of life. That becomes just a very vicious cycle.

So it is very important that we address these medication-related issues. Us as pharmacists will play a vital role, both the consultants and the vendor pharmacists in helping ensure medication optimization. Excuse me. So this is where ZUNVEYL may address both the treated and the untreated. And those who are untreated may, again, experience those adverse events. They might stop the donepezil, rivastigmine, or galantamine, but again, continue taking extra medication they don't need because of their insomnia or GI side effects and due to the transition of care going in and out of the hospital. And those who are treated, again, with the sleep disturbances and the GI upset. So as a pharmacist, we're always looking for an option that can optimize medication therapy, increase efficacy, reduce minimization of side effects.

ZUNVEYL definitely brings that option to us due to the limited options that we have and in turn help our nursing staff and also increase the reputation of our facility.

Lauren D'Angelo
COO, Alpha Cognition

Thank you, Dr. Mohamed. We believe we have a next-generation best-in-class treatment option with ZUNVEYL. And as you heard from our thought leaders today, there is a significant unmet need for better treatment options that patients can tolerate. HCPs are dissatisfied, caregivers are dissatisfied, and there's high, high drug dissatisfaction with this category. Now, what you see on the right are the key attributes we believe sets ZUNVEYL apart from the current options that are available. First and foremost, our drug was purposely designed to minimize absorption in the stomach to avoid overstimulation of the GI nervous system that could lead to less side effects. Secondly, ZUNVEYL is a proven medication. ZUNVEYL converts to active galantamine after first-pass metabolism, which allows us to claim the efficacy of galantamine, which is significant and sustained improvement in cognitive and functional performance.

On top of that, galantamine is the only acetylcholinesterase inhibitor, which, of course, is our active moiety, that has shown to significantly reduce the risk of developing severe dementia. And we believe that we see better efficacy with galantamine because of its dual mechanism of action. ZUNVEYL is not only an acetylcholinesterase inhibitor, it's also a nicotinic receptor modulator. So you've got two pathways that our drug is working on. And of course, as you heard from both of our speakers today, insomnia is a huge issue for these Alzheimer's patients. ZUNVEYL has no impact on sleep. We have zero incidence of insomnia in our label, and there's tons of data that's been published on galantamine that shows it actually improves sleep quality.

We're bringing the established efficacy of galantamine, but we've solved this tolerability issue that's associated with the drug, and we believe that makes us the best-in-class asset in this category. Now, let's talk a little bit about our initial go-to-market footprint. Now, our focus, as you've heard today, is on the long-term care segment. It's the largest volume. It's about 36% of the market, but it also offers us the most favorable market access conditions at launch. We know branded medications are used more commonly in the nursing home setting than they are in the retail or the outpatient setting. This signals to us. Physicians are willing to try newer and better agents for this really frail and vulnerable population. We also know that about 70% of residents in a nursing home will have access to our drug for a $0 copay.

Our plan is to establish market leadership into the long-term care segment, which is about a $2 billion opportunity for our company. Then we'll further expand into the retail setting, focusing on neurologists, which is about an additional $1.5 billion opportunity that we'll have for the company. Now, if you look a little bit deeper into the long-term care segment, Alzheimer's is a huge issue. It affects 7 out of 10 residents. It's the leading reason for placement into the home, and it's the leading cause of death. You just have this huge underserved population sitting in a really condensed market.

And if you think about the current dissatisfaction with current treatment options, the GI side effects, the insomnia, as you heard from our thought leaders today, this increases a lot of risk for those patients and also a ton of burden on the staff that's managing these patients. So when we put ZUNVEYL's product profile in front of those physicians who are treating these patients in the long-term care setting, 88% of them are likely to prescribe our drug. Now, let's talk a little bit about how we plan to execute from a sales force perspective. So what you see on the slide are two maps. The one on the top left represents the Alzheimer's patients that are living in nursing homes across the country. The deeper the blue, the more patients there are that exist.

The map in the middle with the highlights, that's where we plan to deploy our sales force. So as you can see, if you directly overlay these two maps, we are targeting the largest geographies with the highest concentration of long-term care dementia patients. Now, our strategy is to bring on an experienced account-based sales team with demonstrated success in long-term care. If you've heard our story before, you know that Michael and I have been in this space for over 15 years. We've launched several drugs in this segment. We know the sales reps that we need to bring onto this team to be successful. I can share a data point with you. We've already hired 75% of our territories.

If you look at the skill set of this group of people who have already accepted our offers, they've got 10 years on average of long-term care experience, and they've got 16 years of pharmaceutical sales experience. So we are bringing on just a really talented group of people who are going to be effective from day one. We're also obviously focusing on those top plans that matter to the Med D patient population. And then we're right now developing strategic and clinical partnerships with people like Dr. Mohamed and Cathy to ensure that those patients will get access to ZUNVEYL once we hit the market. Now, we've made a ton of progress over the last few months. I'm really excited about the payer work that we've completed. We're excited to announce that we've set our price at $749 per month wholesale acquisition cost.

This pricing is in line with the analog and market research that we've done for branded products in the space. We've most recently talked to those top five plans that represent more than three-fourths of the Part D enrollees. So they're the ones that are guiding us as we set this price for ZUNVEYL. We've got a differentiated asset, and we know that there's going to be a demand for it. Now, we're also on track to submit our Med D bids for 2026. And on top of that, we have identified those top pharmacies across this country who are servicing the homes that we plan to target. And we're having those conversations to ensure that once ZUNVEYL is available in the market, they're going to be willing and able to fill those orders.

Now, I've never been more excited about a commercial team than I am about the one we're building here at Alpha Cognition. The commercial leadership team is completely filled. They're already on board. And if you look at the experience we've brought to the company, just my small leadership team alone, they're experts in their individual functional area. We've got 350 years of commercial experience, 150 years in long-term care specifically, and we've got 140 product launches under our belt. So everybody's excited. We're already working hand in hand, and we'll be ready to go in a few weeks when we launch ZUNVEYL. So in summary, as you've heard today, large but dissatisfied market, patients can't tolerate the current treatment options, huge market. And we believe that we are able to meet this unmet need with the differentiation and the profile that we have with ZUNVEYL.

Now, as Michael made very clear, we are 100% focused on this launch. We are gearing up and ready to go in a few weeks. But we also plan to complete our pipeline, get some work progressed this year where we should have our sublingual formulation complete. This will allow us to target about 20% of the population that can't swallow. I think you heard Cathy talk a little bit about this in her presentation. We'll complete our Bomb Blast Study that we've done in partnership with the DOD by the end of the year. And we plan to kick off preclinical work for Alpha-1062 and acute pancreatitis. So a lot of exciting stuff going on with the company. We really thank you for your interest today and you're interested in our story. And we're going to go ahead and open it up for questions.

Michael McFadden
CEO, Alpha Cognition

All right. If you have questions, you can put those in the Q&A section, and we'll just start taking those down. Right now, I'll kind of emcee this and then call on our respective speakers to answer questions that are suited to their area of expertise. So here's the first one. I think I'll take this one. It's, what is the benefit of the sublingual or intranasal delivery mechanism? Isn't the oral preferred? You're exactly right. For the majority of patients in the Alzheimer's segment, they will use the tablet or oral formulation. In fact, this is an oral formulation market. However, 20% of Alzheimer's patients have difficulty swallowing or cannot swallow at all. And for those patients, an alternative formulation would be helpful for them. Currently, they only have a patch to utilize as an alternative formulation.

We think the sublingual will be highly beneficial for that subset of patients. Here's the second question. Lauren, I'm going to give this one to you. Can you review the pricing and the payments process and reimbursement and why that may or may not be important first year? I'll stop there. There's a lot more, but I'll stop there.

Lauren D'Angelo
COO, Alpha Cognition

Sure. So the driving factor, or one of the largest factors on why we chose long-term care, is because it's not like the retail segment where a patient goes to a CVS or a Walmart and they abandon their treatment because a prior authorization needs to get completed or their copay is really, really high. In the long-term care segment, about 70% of patients are dual eligibles, meaning they're Medicaid, Medicare eligible. So their drug is covered by Part D at a $0 copay. Now, the way that it'll typically work is a doctor will write an order. It'll go to the pharmacy. There may or may not be a step edit in place. Well, they'll have to look to see if the patient has tried a generic. And then ultimately, the doctor signs medically necessary, and the drug gets approved.

It's really important to acknowledge that those patients who are in the long-term care segment have already tried. Most of them have already tried one of these medications. They've already been on probably one, two, or three generics. So by the time they get a prescription for ZUNVEYL, they've already checked that medical necessity box that they've had in generic, and they will get approval to our drug with or without formulary coverage. Now, in the background, my team is having conversations. There are five payers that represent more than 75% of the market. We're having those conversations. We're negotiating now. We will be in the bid process to get on formulary, but really important to highlight that these drugs will go through with or without coverage in the long-term care setting.

Michael McFadden
CEO, Alpha Cognition

Here's the question for Cathy. Cathy, I'm going to summarize the question here. A patient is currently in a nursing home. They have failed or have discontinued multiple agents, and they're currently not on any therapy. How do you think about that patient if a drug like ZUNVEYL comes to market, and what considerations would a treatment team make?

Cathy Parker
VP of Outcomes Centered Healthcare, Eventus

Sure. So first and foremost, like we talked about, the goals. So I would involve the staff, the family, and the patient if they're able to be part of the conversation. But we talk about goals, and most of the time, they're going to want to slow that progression of the disease as much as they can and remain independent in whatever aspects of their care they can. So I would get a thorough history about what they've tried in the past, what their reaction was. And again, most of the time, it's going to be GI or insomnia that has led to discontinuation. But then I would offer a drug like ZUNVEYL and again, kind of say that here's an option where we can help slow the progression as much as we can and help them maintain their independence.

Michael McFadden
CEO, Alpha Cognition

Thank you for that. So here's a question on revenues. It's, what revenues can we expect first year? Let me just comment in general. We're not providing revenue guidance as a company, but let me comment on expectations because I think that's important in long-term care launches and for assets like ZUNVEYL. We expect this product to take a hockey stick trajectory. So you should see modest sales first year. And then as that fourth quarter turns, you should see a sharp uptick that we anticipate will continue for the next four years of commercialization. Here's the why behind that because I'm often asked, well, why would it be slow the first year? It's an exciting product. You've got some differentiation. Why slow? Here's why. Practitioners will hear about the product the first quarter from our sales team. They will do some research. They'll do some diligence on the compound.

They want to make sure what they're hearing is accurate and good for patients. And they're going to try it on one or two patients. Then they're going to monitor those patients for a window of time and determine that they have a good experience. Did the patient respond well? Then they might try to have some more questions about the product, engage, do some more diligence, and they might try it on five or ten patients, a broader audience. And then they're going to look at those patients, monitor them, talk with the treatment team, determine if those patients have had good response. If that occurs, then they're thinking about, okay, where do I put this in my utilization pattern or protocol, or how might I use this product that seems to work really well? That process takes nine months.

So that's why we kind of guide it to set expectations on how the product will launch. We've learned to have launched multiple products in long-term care. They almost always take this trajectory. So I'd be looking for that as you're following the company. Here's a question for you, Dr. Mohamed. You mentioned you're reviewing charts in the nursing homes. You have to do that every month. Is that a law? That's the first question. And the second is, what type of medication or medication recommendation would you make if you saw something that needed to be changed to the doctor or the treatment team or the nursing home?

Hany Mohamed
Director of Clinical Services, LI Script

Thank you, Michael. To answer your first part of the question, yes, it is a law. It's actually mandated by CMS that the consultant pharmacist at the facilities, upon readmission or admission, and monthly, they're asked to review medication charts. Also, on the facility end, they have to actually mandate policies and procedures to ensure that. So on both ends, it's very important because CMS knows that medication-related problems are a big issue, and intensive pharmacist focus can help reduce those issues. When we look at charts, our goal as pharmacists is obviously improving efficacy and obviously reducing side effects and ensuring safety. So the biggest thing to a pharmacist that makes us really, really smile is adherence. Okay? We want to make sure these patients are compliant, they're adherent, they're tolerating their medication. And in turn, that's going to make everybody's life easier.

The most important is the resident's quality of life. Secondly, we're trying to minimize the amount of medications that residents are taking, okay, to reduce the risk of, A, drug-drug interactions, and B, side effects. Like I mentioned before, with these Alzheimer's medications that are out on the market, a lot of polypharmacy is happening. We all know that Alzheimer's is a progressive neurodegenerative disease. It doesn't stop, and that's why it just keeps on going. One of the biggest things, targets that we look at is reducing the insomnia medication that we use to treat insomnia, the medication we treat the diarrhea, the medication we're trying to treat the side effects of the GI. This is very important to us, and it could be the cause of that medication-related problem, which is the generic options that are out there.

So this is something that we always focus on and kind of pride ourselves on since we should be the medication experts. And how do we do that, Michael? We put consultations in the charts. First, like I said, on the operational side, the nurse can call us, "Hey, listen, what other options are there? Here's a good option. Here's a viable option." That maximizes obviously reduces and minimizes side effects. And then on the consultant side, they just put it in the eMAR system, in the electronic health record, "Hey." And then either the provider that's on the floor can either accept it or refuse it. And if they do refuse it, there can be ongoing discussions on, "Hey, let's talk about this patient's condition and assess the benefit versus risk of the other options." And we go from there.

Michael McFadden
CEO, Alpha Cognition

Thank you. That's really helpful and comprehensive. Lauren, question for you. How many LTC homes and/or doctors will the team target in 2025? What % of the LTC market will your team cover?

Lauren D'Angelo
COO, Alpha Cognition

Yeah, we're pushing upwards of 80%. So as I said, we've already filled 75% of our sales force. A few other territories we're going to have filled in the next couple of weeks, and we will reach the high 80% overall. So that map that I shared in the presentation, it's really focusing on those really, really highly condensed, large number of Alzheimer's patients in the nursing homes.

Michael McFadden
CEO, Alpha Cognition

And here's the second question on pricing. So you announced the $749 WAC price. How does that compare with other drugs or expectations in the market?

Lauren D'Angelo
COO, Alpha Cognition

Yeah, we're actually really excited when we made our final decision and set price for ZUNVEYL at $749. So right now, there are two other branded options in the market. They're not even close from a differentiation perspective. Namzaric, which you've heard us talk about quite a bit in our investor deck, it just took a 10% price increase. So they're now at about $620 WAC with no differentiation. So I think what drove our decision, if you guys had conversations with us over the summer and in the past, we really increased it based on what we heard from payers. We got out there most recently. We've talked to every payer that we need to win with in this space, and every single one of them said, "You need to go higher.

This drug is a premium product," and that's the feedback we got as it relates to the current options that are available. So that's where we're at, and we think we're directly in line with market research and the analogs in terms of.

Michael McFadden
CEO, Alpha Cognition

Here's the question, Lauren, for you. It's another market commercialization question. The main drug right now used in Alzheimer's disease, and which drug do we think ZUNVEYL is likely to replace?

Lauren D'Angelo
COO, Alpha Cognition

Yeah. So the acetylcholinesterase inhibitors are the standard of care. So they're used first line every time. And really, if you break down the current market, donepezil has the market share. So they've got about 65% of the market. It's generic. Patients have likely, by the time they get to ZUNVEYL, they've already tried donepezil as that first-line generic. So we will actually, at market, we'll go after those patients who have failed donepezil, and we believe that we will replace the patch, that second option, and that will be where our target will be. It's also important to note that, and I'm sure the thought leaders mentioned this today, that as the disease progresses, the physician adds more and more treatment options. So ZUNVEYL is standard of care. It's going to be used in combination with the amyloid therapies.

It's going to be used in combination with the Rexulti, which is approved for agitation or the psychiatric behaviors. And it can be used in combination with memantine. Even though we have a mild to moderate patient or physicians add those drugs to the acetylcholinesterase inhibitors, so they can use ZUNVEYL in addition to those drugs.

Michael McFadden
CEO, Alpha Cognition

Here's a question. I'll take this one. It's, why would ZUNVEYL or Alpha-1062 work in acute pancreatitis? And why is that an area to look at? So here's the short answer to that question. There's preclinical evidence and data that suggests that galantamine and active moiety of ZUNVEYL reduces levels of pro-inflammatory cytokines and models of systemic inflammation. There's also evidence to suggest that enhancing the pathway by inhibiting acetylcholinesterase increases acetylcholine availability and the activation of alpha- 7. That modulation effect that this drug has will reduce inflammation, which could be helpful in pancreatitis, especially in the acute phase. So that's why we're looking at it. We think the MOA fits very nicely in acute pancreatitis. It's an area right now where no really good targeted treatment. It's mainly managed with opioids and pain medications, and it results in about 5% mortality. So it's a really serious condition.

There's a needed treatment there. But stay tuned. We'll be able to share more information on our compound toward the end of the year. Let's see. Lauren, here's a question for you on the market. You focus on long-term care if a neurologist wants this drug. Is it available to a neurologist or other people in, I guess, the retail marketplace?

Lauren D'Angelo
COO, Alpha Cognition

Absolutely. So we will be distributing our drugs through the standard traditional wholesaler model. So any pharmacy across the country can order our drug, and they're set up to do so. So we're going to where they are versus trying to create a whole new distribution model. And I also like to note that we've actually had an overwhelming response from neurologists. I've never seen so many emails in my pre-launch from an approval where physicians are reaching out, asking for a rep to go to their office. When and if, I should say if and when, we get those emails, we will still send our representative to a neurologist's office if it's within their long-term care territory when you've got a doctor asking to learn more about ZUNVEYL because they can get access to the drug. So we do expect a little bit of retail business.

There's also a lot of, as our thought leaders could probably share, there's a lot of physicians who treat long-term care, and they also have a doctor's office. So they will likely get spillover into the doctor's office that way as well.

Michael McFadden
CEO, Alpha Cognition

Two other questions I see here. I'll take them both. One is, are you providing full-year expense guidance? Yes. We've publicly stated that we plan to spend under $39 million for full year. That's full 2025. And we think that will maintain consistency over 2026. That expense level, combined with the revenues that we anticipate producing with this launch and the cash on hand, should allow the company to move to break even in year three. And then this is a, I guess this is a great question to wrap on. One more. Before I get to my question, we got time for a quick answer on this one, Lauren. Is there a fact sheet or information that investors could share if they have family members suffering from Alzheimer's disease? Where do they go to get information?

Lauren D'Angelo
COO, Alpha Cognition

Sure. So we're in process of developing the materials that'll be posted on the ZUNVEYL website once we're fully in launch and the drug's available. We've been careful not to provide any information because the drug is not available. You don't want to drive people into the doctor's office. Nothing frustrates the doctor more than when he rates the drug and it's not available. So we will have that information available on ZUNVEYL.com as soon as we launch our product. So we're looking at our reps will be in the field mid-March, and drug will be in channel mid-March, and we should have those fact sheets on the website at that time.

Michael McFadden
CEO, Alpha Cognition

Okay. This is a great wrap-up question here from one of the investors. I'm not making this up, guys. It actually came through in our Q&A, which is, "talk to investors about why they should invest in Alpha Cognition." What's the compelling thesis for investing in the company? Look, we've got a great market opportunity in the Alzheimer's category. It's a $9 billion market, so a really big market. We've got a highly differentiated approved product. So we de-risk the opportunity to invest in a pharmaceutical company. And we think because of the differentiation, this product can be very, very successful in this category. The company trades at what I think most investors would say is a discount to peers in this category with the asset that we have. So we'll leave it to investors to determine what the investment thesis is for them.

But we would say great asset, big market, high differentiation. And we've got a management and leadership team that's done this many, many times. This is, Lauren and I will be celebrating together our 32nd launch with this compound. So we've done this a couple of times. Our team around us has over a century experience in both pharmaceuticals, launches, and long-term care. So really excited about what we offer for investors, for patients, for caregivers, for other stakeholders who are affected by this terrible disease. We thank you for attending our update today. We hope it was valuable and a good use of your time. I also want to extend special thanks to Cathy, Penny, for taking their time to present to you today and provide perspective from their area of expertise. And with that, I think we close, Robert.

Thank you all for joining again, and have a good rest of your afternoon.

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