Our first presenting company is Alpha Cognition with CEO Michael McFadden. Mr. McFadden, please take it away.
Thank you, Robert, and thank you everyone for your interest in Alpha Cognition. Today, I'll provide an update on the company, our lead product, ZUNVEYL, and our commercialization efforts that are underway in the U.S. All statements I make today may contain forward-looking statements. The implications of those are on this slide, and I ask all audience members to read this slide if you have questions on the implications of those statements. Now, I'll kick off. For those who may not be familiar with Alpha Cognition's lead compound, it's a product called ZUNVEYL. It's a benzgalantamine, this product that was approved by the FDA for the treatment of mild to moderate Alzheimer's disease, which is a broad label indication that could be used in 80% of patients that suffer from Alzheimer's dementia. This product was approved in the third quarter of 2024.
We launched in April of this year, so our commercial launch is underway. We are focused on the long-term care or nursing home market with our initial commercialization efforts. In the first quarter of launch, we generated over 1,500 prescriptions. While we're not providing revenue guidance for the year, we are providing expense guidance, and that'll be in the range of $34 million- $38 million. We're targeting profitability in 2027. The company believes it has the capital to achieve profitability with our current efforts. We also have licensed ZUNVEYL in an ex-U.S. market in Asia with our partner CMS Pharma, and we've initiated a number of R&D advancements with the compound. Announcements will be forthcoming as we're successful in obtaining ZUNVEYL approval in multiple countries across Asia. You should begin to see that in the first quarter of 2026. A bit about Alzheimer's disease.
Alzheimer's disease symptoms are typically communicated as a slow decline in memory, cognitive function, or behavioral issues that are inconsistent with a person's character or current behavior patterns. Drugs like ours belong to a class called the acetylcholinesterase inhibitor class. Our drug is an acetylcholinesterase inhibitor. It is also an α7 nicotinic modulator. A bit about the class. It's a very large class therapeutic area. Levy and prescriptions are written every year for patients that suffer from these symptoms, and the drugs in this class are used readily as initial first-line therapy all the way through end of life. About 40% of patients, once they are their lifespan, once they have Alzheimer's disease, is spent in an assisted living or long-term care facility. We feel this fits really well with our commercialization strategy. However, the physicians that treat these patients, three-fourths of them are dissatisfied with the current medicines.
That's primarily due to side effect issues such as diarrhea, nausea, vomiting, insomnia, and it can also be due to loss of efficacy with one of the compounds in the class. It seems to lose efficacy after about eight months of therapy. Additionally, patients are dissatisfied and they vote with their feet. 55% of patients that initiate therapy will stop that therapy within 12 months, which is indicative of a side effect profile that makes these drugs challenging to take. We think that sets the stage for a product like ours, ZUNVEYL, to be highly disruptive in this class. Let me talk about ZUNVEYL, what it is. This is a prodrug of galantamine. Galantamine was a Johnson & Johnson-approved drug back in the early 2000s, deemed the most efficacious drug by most ever approved for Alzheimer's disease. The drug was beset by side effects and tolerability challenges.
It wasn't really ever used in a significant manner because it was so hard for patients to take. Once the product lost patent exclusivity, the lead scientists for the Johnson & Johnson program modified the chemical structure and added benzoyl ester or gluconate salt for increased solubility. We added a proprietary coating around a tablet formulation of this drug, which allows the drug to bypass the GI tract, the small intestine, with active drug release. This minimizes many of the side effects seen with other drugs in this class. Our drug is then subject to first pass metabolism where the tablet coating is filled out, the esters lead to active drug release occurs in the brain. We get about 15% more drug in the brain where it's supposed to work, and we minimize delivery of drug in the GI tract and small intestine where it shouldn't be present.
Thus, we believe we have a really well-tolerated compound with active effects in the brain, which is the goal of this drug class when physicians treat it. Now, I mentioned this is a very techy slide. I'll mention two things about our compound. It has an effect on acetylcholine. It increases acetylcholine synapse of the brain. The impact of that is improved cognition. It also, though, more profoundly modulates the α7 nicotinic receptor. This is important because it stimulates a pathway in your brain called the cholinergic pathway, which enables you to remember, enables you to process what other people are saying, and react to that. Additionally, our drug has a downstream effect on other receptors like dopamine and glutamate, which are responsible for effect on behaviors that can occur with Alzheimer's disease. These behaviors typically are most commonly aberrant motor behavior: pacing, repeating, scratching, pulling, or agitation, anxiety.
There are multiple other behaviors that do occur with disease. Our product has demonstrated pretty robust effects with those behaviors. Now, let me talk about the class. That's how the drug, that's what the drug is, how it works. Let me talk about the class and talk about differentiation. We believe that ZUNVEYL has versus the leading compounds that are used. I'll go through the class and then talk about those differentiation points. The class is led by a drug called donepezil or ARICEPT. It's a generic compound. This drug is used in about 70% of patients that have Alzheimer's disease. A second drug is Exelon. It's typically used as a patch formulation. The patch is used in an attempt to bypass drug effects in the gut and minimize GI side effects.
To some degree, that is true, but this drug also has a number of issues with skin because it's a patch with skin rips, skin tears, bleeding, skin irritation, etc. That drug is commonly used about 20% of the time. Then galantamine is seldom used. It's less than 5% of all patients. There are a number of patients that are untreated, also in this class. Either they have tried and failed all drugs, or they have tried and failed at least two. Now, how does our drug differ from the current drugs that are available for patients to take and doctors to try? It really is in three areas of differentiation. Number one is tolerability. Our drug has been purposely designed with prodrug technology. We have a delayed-release compound.
We have a proprietary coating that prevents active drug release in the GI tract, and that minimizes side effects that are commonly seen with other agents in this therapeutic area. In our clinical work, less than 2% of patients had GI issues. Since we have launched the drug into the U.S. market, we've had two reports of GI side effects in over 1,000 patients on medication. We're not saying that more side effects haven't occurred. That's what's been reported to the company, but it bodes that we have a well-tolerated compound. Number two, our drug has 0% incidence of insomnia. The two leading compounds in this class have a 30% incidence of insomnia or sleep disruption. That's very important for an Alzheimer's patient.
If you can't sleep in this therapeutic area, your disease degradates fairly rapidly, and a good night's sleep minimizes many issues, not including disease degradation, but minimizes nighttime awakening and mobility challenge patients from having issues of falls. Number three, our drug differentiates from other drugs on proven cognitive effects and functional performance. We use data out of Europe that demonstrates galantamine, the active modality of our drug, has strongest effects on cognition and had the strongest effect on progression of disease, meaning delay in progression of disease. Last but not least, our drug has a strong effect on behavioral symptoms that do occur about 80% of the time with Alzheimer's patients, and that's primarily due to its effect with glutamate and α7 nicotinic modulation.
This is a very important aspect of drug care in this class because many patients suffer from these behaviors, and that leads to institutionalization, and/or if they're in a facility, it leads to significant challenges from staff in managing these patients. Now, let me speak to our launch strategy, how the company has gone to market, and our focus over the course of the coming months and weeks. We have chosen the largest segment in this market. It's called the long-term care. You see it on this slide, LTC. That's the nursing home market in the U.S. Why? It's the largest market. It represents a $2 billion opportunity for ZUNVEYL. Number two, it is highly concentrated. About 75% of patients in a long-term care facility have Alzheimer's disease.
Number three, we believe it has the fewest payer restrictions, so it allows us to get drug to patient without some of the challenges that would be present in the commercial marketplace. Four, the doctors who treat these patients are highly concentrated. They have long-term care practices. Basically, all they do is treat patients in nursing home settings, and they're very seasoned and experienced in treating Alzheimer's disease. We can manage this with a very small sales footprint. We have about 50 salespeople. That gives us critical mass in the market and provides stay state on a go-forward basis for the company. Two additional comments in long-term care. There are 1.2 million patients in long-term care facilities. 70% have Alzheimer's disease. That represents about 850,000 patients. There's a very large patient population in this disease area for us to target.
About half of these patients are stopping their medication over the course of a year. It's typically due to side effect issues. They can't tolerate their medicine or the medicine has lost effect from a cognitive symptomatology, and the patients are looking for, or the doctors are looking for, an alternative treatment regimen for those patients. I'll speak to where our sales footprint is. We have about 50 salespeople across the United States. They're typically in large metro markets where high concentrations of patients reside. We call on medical directors. We call on the nursing home itself, typically the Director of Nursing, and we call on consultant psychiatrists. These are psychiatrists who typically will ascertain and consult on behavioral issues that occur with Alzheimer's disease. These are our three targets. To date, we have called on almost 2,000 nursing homes.
We have about 15% of those homes that have written prescriptions or processed orders for ZUNVEYL. We've called on over 1,500 doctors, and about 400 of those physicians have written orders for ZUNVEYL, with about two-thirds repeating those prescriptions. We think that bodes really well for the future. It builds a good foundation in this category for the company. We expect to see that exponentially grow over the coming quarters as our team spends more time with the physicians, educating them on the class, educating them on our drug, and the physicians have some experience with the medication to understand how to use it and to understand the tolerability profile and what patients might benefit from this therapy.
Additionally, in this category, we'll be looking for clinical and/or strategic partnerships with pharmacies, long-term care facilities from an educational perspective and/or other perspectives to strengthen the ZUNVEYL promotional opportunity in long-term care. I'm always asked about payer. How is the drug covered? Can doctors get the drug if they write the drug? Yes, they can. We've made early advancements in the category by solidifying our first national contract with one of the PBMs. This accounts for about 17 million potential lives that can be unrestricted. It'll take about six months for this to work through the system as PBMs sell the benefit designed to downstream clients like health plans, and they make determinations on how they're going to cover the drug. We also have a reimbursement team that's supporting our efforts with the nursing home providers, and they assist with prior authorizations when and where those exist for ZUNVEYL.
As you may be aware, most new drugs are prior authorized when they launch in their first year. Our drug is no exception. Our reimbursement team really helps guide and work with the doctors to obtain approvals for ZUNVEYL. A bit on the financials. We generated about $1.7 million in revenue our first quarter. It's about what we expected, and we anticipate that will grow steadily this year. We should have a sharp acceleration in 2026 as doctors have worked through the initial trial of ZUNVEYL, and they are figuring out where this drug may fit in their protocol or in a patient type that they would use with regularity. Additionally, we've managed expenses fairly tightly. We'll see some increase in expenses in the last two quarters of the year, but we're guiding to $3 4 million-$38 million range on our expenses for the company.
This puts us on a path to profitability in 2027. We're excited that the company will begin generating cash in a very short window of time. If we achieve average or normal penetration in this class, we could have a $200 million- $600 million drug potential with ZUNVEYL. That would be a drug that's taking 10%- 25% of market, which we think this drug has the potential to do based on the differentiation it has shown in the marketplace. We additionally raised some additional capital in the last few weeks. We raised $35 million, adding to our balance sheet. The company is sitting with slightly under $70 million in cash on a go-forward basis. Now, I've talked about ZUNVEYL. I'll close the presentation with two slides, one on pipeline. We have two pipeline assets that we're advancing for the company.
We have a sublingual asset that we are working on formulation work right now. We will run a PK study on that drug, announce those results in early 2026. We think that can lead to an IND with FDA for the treatment of mild to moderate Alzheimer's disease. Now, why you might ask, are we using or testing a sublingual product to bring that forward? 20% of patients have difficulty swallowing or can't swallow at all. Those patients today use the patch or have someone mash their tablet and mix it in applesauce and then have to administer the medicine to them. We think a sublingual that dissolves on your tongue in five seconds will be a welcome alternative to the choices that physicians and healthcare providers have today. Secondly, we have a product that we're advancing for treatment of cognitive impairment with concussion or mild traumatic brain injury.
We'll have additional data on that product mid-part of next year. We think that toxicity work that we're doing with that compound will lead to an IND at the end of 2026. That's an exciting area and a very large area, $13 billion market opportunity in concussion for the company. Additionally, we have a number of milestone events left to complete this year. We're on track to complete those milestones. Next year, it's a year of sales, it's a year of drug approvals, it's a year of advancement of our pipeline, probably the most exciting year in the company's history. There are a lot of things to be excited about with what the company is trying to do. You can't do that without a great team. We have a great team. I have about 35 years of experience. My 16th product launch, Lauren D'Angelo, is our Chief Operating Officer.
She also has 15 drug launches, and this is her 16th. We're celebrating that together. Henry Du leads our finance and accounting, and then Denis Kay is our Chief Science Officer. Denis has spent over a decade on this compound. I call him the world expert in ZUNVEYL. We bring a good experienced commercialization team to the ZUNVEYL story, and we're very excited about what we can deliver in the US marketplace for our shareholders. I'll leave our cap table here as our time is coming to an end. I'll turn it maybe back over to Robert to take questions from the audience. There's a Q&A bar, by the way, at the top or bottom of your screen. Feel free to drop in your questions, and Robert and I will try to manage those with the time remaining. Robert? I'm seeing one question here on cap table.
We just raised some capital. This cap table is pre-capital raise. You'll see some additional shares go into the cap table. It will be about 27 million shares post that capital raise. That cap table will be updated in the days to come. Stay tuned for that information. Robert, other questions?
Thank you very much for that presentation. It sounds as if ZUNVEYL has addressed and solved some of the GI issues that have held back the use of these acetylcholinesterase inhibitors. Your target market at this point is the long-term care and nursing home facilities. Are you planning to address some of the mild to moderate patients, or is that something that you're expecting to go after once the sublingual form is approved?
We are addressing mild to moderate today. Most of the patients actually in a nursing home are mild to moderate Alzheimer's patients. About 80%- 90% of patients in a nursing home have mild to moderate Alzheimer's disease. That's the only area we promote in, and certainly we're focused on those patients today in the long-term care setting. To your point, in the neurology segment and the primary care segment, there are many, many more patients out in the marketplace. Those markets actually represent a $1.5 billion opportunity in neurology for the company. We do plan to advance and launch into the neurology segment once we achieve break-even status for the company. We look forward to that in 2027, being able to launch a neurology force into the neurology market. Today, we have neurologists that are already writing product.
We have primary care and internal medicine doctors already writing product for their patients. They can get the product. Patients can buy our product at the pharmacy. It's covered with their Copay or their MedD plan typically. They can get it, but our focused effort in that segment will come in about a year, a little over a year.
Sure. Okay. Your choice of segments addresses many of the problems that the patients in nursing homes are facing. That sounds like a very good choice and a great initial starting point. You mentioned the two mechanisms of action. Would these apply to other neurological conditions?
Yeah, that's a great question. When people hear the word α7 nicotinic modulation, if you're a pharmacologist or you have a science background, you immediately go to 20 different conditions this drug could be used for. Indeed, that's probably true. A small company like ours, our road to success, our road to rewarding shareholders is really focused. We will maintain focus with the Alzheimer's market that we're in. We are exploring cognitive impairment with mild traumatic brain injury, same assets, same drug, same active modality in that category because the condition does parallel some of the issues in Alzheimer's disease: mental confusion, slowing of mental processing, inability to remember, inflammation in the brain. Our drug does seem to have an effect in all of those areas. We think it likely has a good chance of demonstrating success in the mild traumatic brain injury.
There are additional probably 8- 12 indications that we will look at over the future to determine if we choose to advance the product in other conditions.
Okay. Just one question on sales. Do you know the actual size of the acetylcholinesterase inhibitor market and the peak sales of Razadyne, the base molecule that you've improved on? I know it's not a fair comparison because you've got an extra mechanism of action. If you were to replace Razadyne on a unit volume or take market share for the acetylcholinesterase inhibitors, any ballpark estimates of where you would be?
Yeah, that's a great question. I'm going to go back to one of the slides to let everybody see an illustration as I talk about this. The long-term care acetylcholinesterase inhibitor market is a $2 billion market in the U.S. The neurology psychiatry market is $1.5 billion. Add those together, $3.5 billion market. PCP and other add another $2 billion to that. In total, you're looking at a market size that is about $6 billion- $7 billion in the acetylcholinesterase inhibitor class. It's a huge market. The interesting thing about this market, one reason we're so excited about it, almost every product that has launched in the category has achieved billion-dollar sales. Donepezil, multi-billion-dollar sales at peak, Razadyne, multi-billion-dollar sales at peak. Galantamine, to your point, Robert, it probably had the weakest of all of the drug sales, but it still achieved $250 million in sales for that compound.
We see that as a base case for what this drug can deliver. We think that with the differentiation that we have, we could see something much north of that if we're able to execute well in both long-term care and ultimately in neurology.
It sounds the team that you've assembled has tremendous experience in launching drugs in these fields. I think you've certainly stacked the deck in your favor. The size of the opportunity is enormous. Without asking market share questions, it sounds as if you wouldn't need to be the best drug in the category, even though you are.
Yeah, we think we are. We think the drug's highly disruptive in that regard as multiple differentiation points. You're right. A drug with modest differentiation should be able to achieve north of $200 million in the long-term care segment alone and north of $300 million -$400 million in total category. We believe our drug has many more differentiation points. That's one reason we're excited about potential upside for ZUNVEYL. That said, we have to execute well. We have to educate the doctors, their staffs. We have to communicate the scientific information on our drug so that doctors do feel comfortable with it and then work with all of the associations for guidelines and strategic opportunities, which is what the company's focused on doing.
Terrific. Thank you very much. This is a very interesting presentation, and I'll be looking forward to following the company and the sales progression.
Thank you, Robert. Thanks to our audience for joining in. Thank you for your interest in Alpha Cognition. You're welcome to follow us at alphacognition.com. You can sign up for updates. Our stock symbol is ACOG, so you can put us on your stock trackers. We welcome your followership and cheering us on as we try to have a great US launch.