Good afternoon. Next up, we have Arun from Coya Therapeutics.
Thank you. Good morning, everybody, and thank you. Really appreciate it. There are these famous people I'm going to start naming, and you'll see the connection to Coya. Lou Gehrig, the baseball player, the former Yankee. He was called the Iron Horse because he played more than 2,000 games without missing one, right? Stephen Hawking, physicist, astrophysicist that has done some amazing work that has made advances in this world. Bruce Willis, movie actor, most popular for Die Hard movies, right? And Ronald Reagan, of course, our president who famously brought down the wall, right? What do these people have in common, and why am I talking about them? Our vision at Coya is to make the stories of not just these famous people, but make the stories of everybody be about their life and not about the disease that all of these people had.
What was common in all these people I talked to you about is they suffered from severe neurodegenerative diseases. In the case of Lou Gehrig, the disease is named after him. It's amyotrophic lateral sclerosis. Cut short his career. His record was held for a long time until Cal Ripken Jr. broke it finally, right? Stephen Hawking, again, a patient with ALS, famously known for doing complex physics while sitting on a ventilator in a wheelchair. Bruce Willis, recently diagnosed with frontotemporal dementia, a very progressive disease that, as the word defines, causes dementia, but also other forms of physical issues later in life. Ronald Reagan, of course, everybody knows the famous story of his people putting leaves in the swimming pool, and he suffered from Alzheimer's and dementia towards the end of his life.
Our vision at Coya is to make these diseases livable diseases, stop the progression, and allow people to lead a normal life. That is the ultimate goal that we are working towards. Before I go into our technology and what we do, I wanted to highlight some of the key things that we do at Coya and why we believe that we have a strong story. One, our science is strong. We target a particular cell in the white blood cells that bring down inflammation. By bringing down neuroinflammation, we can address a lot of these diseases. We target diseases, as I just told you, with a high unmet need. What does this do? It allows for a faster regulatory pathway.
The new FDA commissioner only two days ago announced that he plans to revamp the FDA to be more efficient in approving drugs for diseases such as ALS and FTD and rare diseases where patients today have really no choice. We have de-risked our approach by taking targets that are established in other disease areas and applying them to neurodegenerative diseases. We are not expecting to see any surprise safety issues, et cetera. All of these diseases have a high commercial value, over $10 billion in value just of the diseases we are pursuing. Our lead product has the potential across all these diseases I talked to you about, which is why we call it a pipeline within a product. Our cash flow is strong, and our cap table is clean. We have $38 million approximately when we reported our earnings last time.
It takes us well into 2026. We have line of sight to non-dilutive money on a steady basis coming into Coya, which is a unique differentiator a company like ours has for the market cap that we have in our fold. I'll get into a little bit more detail about our partnership with a company called Dr. Reddy's, a $13 billion multinational company. We have a very accomplished management team and board. Everybody in our management team has created value and has been great at execution, not just at Coya, but in previous companies they've been at as well. Our board has top pharma people and former pharma people. We have the former CEO of Bayer, Dieter Weinand, on our board. We have the former Commerce Secretary under the previous Trump administration, Wilbur Ross, on our board as well.
We have a very strong board and management team. We also have a strong investor base. We have David Einhorn, Greenlight Capital is our largest shareholder at 9.9%. We have a biotech fund, AIGH, that has a pretty reasonable interest in us as well. The management team collectively has about an 8% position, including many of us bought when window opened last time shares in the open market. I told you the diseases we're focused on, and these diseases have immense commercial potential. What we want to be able to do is to make a difference for these patients. I'm one of those people who strongly believe that if we do what's right for the patient, these sales will come.
It's really about making sure that we are keeping the patient at the center of what we do, help develop the right drugs, and all of this will come. ALS, we have the potential to be in the market if everything goes well as early as 2027, over a $1 billion potential in the United States alone, over $3 billion globally. Similarly, all the other diseases can be pretty significant. Of course, when you get into Alzheimer's disease and Parkinson's disease, the size can get pretty large. It really depends on what population we target in those. I'm not going to go too deep into the science. If any of you are interested, I'm happy to talk to you deeper about that after this presentation. But very briefly, what we do is analogous to keeping the spark plugs working. Our neurons are like spark plugs, essentially.
They are firing and communicating. When they communicate and fire well, everything works well in the nervous system. Everything is going well. The minute those spark plugs start misfiring, what happens is similar to what happens in an engine. It either stalls, it does not start properly, or it does not start at all, right? That is exactly what happens in neurodegenerative diseases, where when the neurons stop communicating properly, when they start getting sick and when they eventually die, it leads to the different neurodegenerative diseases, whether it is ALS, whether it is Parkinson's, whether it is Alzheimer's, and so on. We fundamentally address the neuroinflammation that drives this. Diseases like ALS and FTD are like forest fires. They rage and they spread fast, and patients tend to have a very short lifespan after diagnosis. Diseases like Parkinson's and Alzheimer's, patients tend to live longer. They are like burning embers of coal.
They take time to do the damage, but they eventually do the same damage. We are addressing inflammation at the fundamental level, at the neuronal level that then addresses everything downstream. We have seen great results so far. The clinical results we have seen to date give us a lot of confidence that our approach is working. We have shown consistently across multiple diseases that we stop the progression of these diseases. Nobody today has any drug in the market or any data that shows that we're able to stop the progression. Stopping the progression is the holy grail right now. I mean, cure would be the super dream, but right now, if we can just keep patients from not getting worse, that is a big win in itself. I already talked about this.
Our lead product, COYA 302, which is a proprietary combination of a low-dose interleukin-2 and a CTLA-4. Again, happy to go deep into the science on any of this in our one-on-ones or after the meeting. We're pursuing it in multiple diseases. Our lead program is in ALS. We expect to start a registration phase 2B study this summer, this fall. That is one study. If the results are good, we will likely get approval from the Food and Drug Administration and allow us to get to the market in 2027 in a market that the last product to launch and subsequently withdrawn made $650 million the first year that it was launched. This is a market where the uptake is going to be rapid. Insurance reimbursement is strong, and globally, access will be pretty reasonable.
For ALS, we have entered into a partnership with this company called Dr. Reddy's. Their ticker symbol is RDY. They're about a $13 billion market cap, depending on their stock price. It's a $700 million deal. This really is one of the things that, from a business perspective, differentiates us as a company. For a $100 million company, we have a partnership that gives us steady line of sight to non-dilutive money, which means as investors, it is unlikely that we're going to be doing a lot of raising capital market and so on because we have something that many others don't have, a non-dilutive line of sight to cash. We will be getting $8.4 million later this year when we start this clinical trial from Dr. Reddy's. Again, this is not an exchange for equity. This is non-dilutive cash coming into the company.
We're already well positioned from cash, and this $8.4 million will be coming later on in this year as well. We have line of sight to another $40 million in the next couple of years. Of course, a caveat to all of this is we have to hit our milestones. And then up to $600 million plus in sales milestone and mid-teen % royalties on the sales as well. We could be in a unique place where for a biotech company, we could be cash flow positive in 2027, 2028, which is not something you hear from a biotech company too often. Now I'm going to get a little bit into the disease and ALS, just very briefly. The score called ALS-FRS, don't worry about what it means. The lower the score, the worse the patient is doing.
Patients typically decline about one point a month today with all the therapies that are available to them. This is from a large database that comes out of Mass General and Harvard University. One point a month means six points in six months, 12 points in one year approximately. What does that mean clinically? Six points is the difference between a patient walking with a cane versus being on a wheelchair, as an example. Twelve points is the difference between walking with a cane and being on a ventilator. In patients, this can happen in one year or two years from diagnosis. Most ALS patients die three to four years after diagnosis. What you see on the other side is the drugs. One has been already withdrawn because it does not work, but the drugs that are currently in the market do not work.
We did a study, and what we saw is that we stopped the progression of ALS. The patients came in with a score around 33.5, which means they're mild to moderate ALS patients. They're already symptomatic. At the end of the study, six months, there was no change. As I showed you in the previous slide, 33.5 should have been around 27, 28, 26, but we were at 33.5. This is dramatic. This is really exciting for us. At one year, they barely dropped. They dropped by about one point when they should have dropped by about 12 points. When we stopped them, what you see in the pink line, they started declining at the rate of one point a month. That is also important to keep note that the minute we stopped the therapy, the patients started declining again, which tells us that it is working.
It's doing what it's supposed to do. Of course, it also means that the patients have to take the drug for their lifetime. As I said before, our vision is if we can stop and keep people on this flat line, that will be a huge, huge win. Nobody's shown this. This data was compelling enough. We have met with the FDA. We have talked to them. I won't go into the details, but we're going to do a phase 2B study, a registration study, a well-controlled placebo-controlled study in approximately 120 patients. We have a lot of good criteria that make sure that the right types of patients are coming in. We'll be measuring a lot of things, including that endpoint I just showed you, the ALS-FRS, which is the endpoint the FDA approves a product for ALS on.
We anticipate beginning, starting this trial in the second half of this year. It is a pretty fast trial because it is a six-month endpoint. We can submit to the FDA at the end of when all the patients have completed six months. We plan to continue the study past six months into a year to get more survival data and additional data, but we can file in six months. Currently, there are very few trials in the ALS space. We believe, based on our conversations with the various hospitals around the United States and Canada, which is where we plan to do the studies, there is a lot of enthusiasm. In fact, our Chief Medical Officer gets a lot of emails from patients wanting to be part of this trial. We believe that the recruitment can be reasonably fast.
It won't take us that long to get to the top line once we start this study. As I mentioned, we also pursue frontotemporal dementia, a related disease to ALS. There's a genetic component to ALS, and there's a non-genetic component. 80% of patients have no genetic connection. The medical terminology is sporadic, which is a fancy way of saying nobody has a clue why these patients get ALS. 20% of the patients carry a couple of genes, SOD1 mutation, C9ORF72. There are certain mutations that put patients, people at extremely high, unfortunately, almost 100% risk that they will either develop ALS or frontotemporal dementia. We are proceeding also with FTD. We're hoping to have some data to share with the market in the not-so-distant future, hopefully.
Our science was exciting enough, and our data to date in ALS and Alzheimer's disease combined together really impressed the Alzheimer's Drug Discovery Foundation, a top-notch foundation that is very high science, high scientific rigor. They invested $5 million in Coya to support our moving forward into a clinical trial in frontotemporal dementia. We will be starting; we will have the top-line results from an ongoing small trial, hopefully relatively soon, and that will help us inform the design of the phase II-B trial. Again, it will be very similar to the ALS trial, where it will be a double-blind randomized control trial. We expect to file that with the FDA towards the end of this year. We also have other assets in our pipeline, and I will talk to you a little bit about those in a second.
Our proprietary low-dose interleukin-2 COYA 301, we presented data in patients with Alzheimer's disease. Again, I think what you're going to see is a consistency in our response across these three diseases. We're stopping progression, which nobody has shown to date. Again, it's a double-blind randomized control study. We did a smaller study earlier, which I'm not showing here to you, which was only eight patients, which showed that we stopped the cognitive decline in Alzheimer's disease. We stopped the patients from declining in their cognitive ability. This really impressed the Gates Foundation and the Alzheimer's Association, and they funded the study entirely. We spent very little, maybe $200,000 of Coya's money in running this trial.
That's the other thing we have done well as a company is almost every data I'm showing you, we generated using so little of our own cash, which is why we are able to have such a low cash burn rate for a biotech company. Again, something I believe truly differentiates us from our peers. I'm not going to go into the details, but consistency in our story. Cognitive decline was stabilized, meaning patients did not get worse. This is not something you see. The approved drugs that are in the news every day from Eli Lilly, Biogen, they slowed down the progression of Alzheimer's disease by about 20%, meaning patients are still declining in their cognitive function. You're just kind of postponing it or slowing it down a bit. What we saw in this study is that we're again stopping cognitive function decline.
It's measured by these scores called ADAS-COG, which is all cognitive measure scores that the FDA approves of. We also saw in the spinal tap of these patients something called A beta 42 go up. For those of you that are familiar with the Alzheimer's science, when A beta 42 in the spinal cord goes up, it means plaque is being removed from the brain. That's a good thing. We remove plaque in a slow manner, and that's not our primary mechanism. Our primary mechanism, as I told you before, is stopping inflammation, stopping that forest fire, stopping that burning embers from spreading to begin with. We hit it at the source. By not removing plaque really fast, we don't see a side effect that you probably see on the news with these Alzheimer's drugs, which is why their sales are being highly limited.
It's called ARIA, which is amyloid-related imaging abnormality. In more simple words, what it means is because the plaque gets ripped off, and I don't mean to be graphic, it causes microbleeds. That's what happens. That's ARIA to these patients. That can be devastating. We don't see ARIA because we don't do it in the same mechanism as these beta amyloid drugs do. Some of the key takeaways from all of our studies is that we believe this combination approach of our COYA 301 with a CTLA-4, which is COYA 302, COYA 301 with a GLP-1 agonist, which I'll share with you in a second, is the way to go. Combinations is the way to address these complex diseases. Similar to oncology, similar to diabetes, similar to HIV, what works in these complex diseases is that one size doesn't fit all.
You have got to hit the disease in multiple angles, and that is exactly what we do. We are starting to see that it is working. It gives us a lot of confidence in our outcome in the bigger trials that are about to begin. Lastly, I just wanted to touch upon the GLP-1 combinations we have. Of course, GLP-1 has become a household name. These are the obesity drugs like Wegovy, Mounjaro. What is amazing about this is that we are developing a combination of our product with GLP-1s. Why, you may ask, and why in neurodegenerative diseases like Alzheimer's diseases? In January, and of course, we have known this for a while, but in January, there was a publication in Nature, which is one of the top medical journals. 1.5 million patients, diabetic patients, were studied by the VA healthcare system.
They looked at who took GLP-1s and who took other drugs to manage their diabetes, whether it's metformin, sulfonylureas, DPP-4 inhibitors. What was remarkable, and 1.5 million patients, what was remarkable is that patients who are on a GLP-1 for their diabetes had lower onset of dementia and lower progression of dementia. What we are showing is that combining our asset with GLP-1, 1 plus 1 is 3, not 2. We are synergistic. We work better, we work more effectively, and we have the intellectual property behind it. This is attractive for many reasons. One, obviously, scientifically, this is exciting. We think that there is an immense value-creating potential for Coya here. The GLP-1 companies love this concept because Cash Cow for Eli Lilly and Novo Nordisk is their GLP-1s. Patents are expiring in the early 2030s, late 2020s in some countries.
They are looking for ways to expand their footprint and keep their cash cows. We have the intellectual property for them to be able to do that. We also have the ability to take them to diseases that they have not been in. If you are a new company developing GLP-1s, you absolutely want to differentiate from Novo Nordisk and Eli Lilly because just coming in with weight loss is not your job with weight loss. We feel pretty excited about the value-creating potential around this. Just to wrap up, we have an exciting 2025 and 2026. What you are going to see from us is there is going to be a constant, hopefully constant, positive news flow from us. We have already delivered on a few of these. We have shared some more exciting data from Alzheimer's disease showing that we do address inflammation at the cellular level.
We, a couple of days ago, released our GLP-1 combination data showing it's synergistic. I think the market liked it based on the reaction. We have a bunch of other things coming. FTD data soon. We'll start the ALS trial. We'll get $8.4 million in non-diluted funding this year. We will file FTD with the FDA and so on. Almost on a weekly, monthly basis, I believe we are constantly building and creating value at Coya. I'll pause there and say thank you and happy to take any questions. Yeah, the question was, I said non-diluted and what's in it for the strategic partner, Dr. Reddy's. They get the rights to commercialize it in certain markets, and they give us royalty, mid-teen royalties in return. They get to keep the sales, part of the sales from it.
That's what's in it for them. And it's non-diluted because it's not in exchange for any equity in Coya. Next one here. No, it's a short answer, of course, unless you count our licensing revenue from Dr. Reddy's as profits. I've got to talk to our accountants on what I can officially say about it. But yes, we will be getting non-diluted cash coming into the company, but not through sales of a product. Sales, the earliest expectation we have, assuming everything goes well and the FDA approves, is 2026. How is the ALS product pricing? Yeah, I mean, obviously, the price will be determined a little bit by the data and our negotiations with the payers. But the last product that launched was priced at $200,000 a year and fully reimbursed by all major insurance players as well as by Medicare.
Also, the difficult provinces of Canada approved reimbursement really fast for those products because there is no other option for these patients. The nice thing about diseases like ALS and FTD is they do not break the payer's budget. That's what they're worried about, right? If you're an insurance company, you push back if you think suddenly 20 million people are going to be using it in a year because then you push back because it's going to break your budget. That's not the case with ALS, and it won't be good PR for them if they deny ALS and FTD patients as well. I think we're coming up on time, it seems, but our trials are going to be in the U.S. and Canada. That's our current plan. Thank you.