Let's talk about Cinclus Pharma and our substance drug candidate linaprazan glurate, and specifically also the disease gastric acid reflux disease, or severe erosive GERD, specifically, we're going to talk about today. We are in a market where we actually have a huge, large unmet medical need, and our substance definitely have a blockbuster sales potential when it will be approved in some years. We also have a substance that clearly are differentiated versus other alternatives in the market, and where we have a unique acid control 24 hours, which I will come back to. And also, we're talking now, we have our first phase III trial coming closer to the readout actually in weeks or months in Q4. So it's a very interesting potential value inflection point for us and the catalyst for the company overall. Let's look into the market. This is a huge market. We're talking about in U.S. and Europe, 130 million patients suffering from GERD or reflux disease. This is a disease that we have seen many different alternatives over the decades, but for the most severe patients suffering most from this disease, we see approximately 20 million patients globally, whereof 10 million are from U.S. and Europe. In this population, we know that up to approximately 50%, every second patient are not healed, with the ordinary drugs like Losec and Nexium. Almost every second patient are complaining from pain still after PPI treatments. So this is a huge, big market. We are also treating chronic disease. It's chronic patients. They never get better. They can actually progress in the disease. If you don't heal them, then there is of course, a risk of progressing to more severe diseases like cancer. It's a very dynamic market with many different switch opportunities, which is perfect for a product coming in and launching as best in class. This disease is very much caused by acid content going in the wrong direction up into the esophagus. That cause pain, but also it cause erosions or actually it's frying up the mucosa in the esophagus. And of course, for the severe patient, it's really tough disease. The only way to actually to heal these patients and help them is to make sure that you more or less cut the acid production in the stomach, or at least get full control of it so you have pH level above four in the content. Our substance is the one that actually can deliver that. We can deliver it 24 hours. We have 96% acidic control over the 24 hours period. You can see the other alternatives that exist in the market. We started up with the PPIs, who became the most sold drugs in the world with Nexium and Losec. Less acidic control. First generation of PCAB, the new class, which we also represent. We can see now, 60%-85% acid control. That was enough to become the most sold drug in Japan, where they were launched with $1 billion there in sales only. So this is a huge market, and now we actually have a unique product actually that can deliver full acid control that's needed for helping these patients. We also have seen that in our phase II trial, that we actually really help the severe patients. We actually ordered it there in the phase II were superior versus the PPIs, which is definitely important to launch a product in this sector. Now we are waiting to repeat that results in the HEEALING 1, the first pivotal phase III trial that we will have the readout in Q4. When it comes to the commercialization, we can say that we have a really good partner already in Europe, where we are working together with a company, Zentiva, previously owned by Sanofi and Advent. We have a deal value up to EUR 220 million, but also looking into the royalty possibility, 20%, which is definitely very good royalty. Also have in mind, I said about Japan before, with $1 billion in sales, launching the first PCAB. Europe is actually 4x bigger in population and the price level comparable with Japan. So of course, 20% royalty could be a really interesting future for us. In China, as we speak, we have a launch going on there together with Sinorda and Huadong Medicine, and it looks very promising. The first quarters now, we have full reimbursement in China, good pricing, and the buildup of the drug there looks perfectly in line with plans. Last but not least then, is the U.S. rights, which we actually by purpose are waiting to sign with an industrial partner. Of course, we want to see and read out the first phase III HEEALING study first before going forward with the U.S. market. When we launch, we will have at least 10 years in U.S. and Europe with full protection. So that is, of course, very good period to work on. In U.S. and Europe, we actually have patent until 2042. The clear path to approval is also there. We only have one phase III trial to go, and that should be initiated directly after the first phase III trial that will end now in the next quarter. We have an expected approval time of 2030 after the readout of the last study clinical trial. Cash runway is also there. We have another year to go, so we have a good margin to get the results from the first pivotal trial to actually fund the last trial in this program. Just to summary then, before going open up for questions. This is an interesting, at least what I can see, an investment case where we have definitely a very interesting substance, meeting an unmet medical need within the sector with a huge sales potential. We have seen it within this market before, that when you launch products in this market, there are so many patients. Even though we are focusing on the niche population, 10 million in U.S. and Europe and 20 million total globally, we definitely can have a great chance to reach a blockbuster sales. The product is fully differentiated and well-positioned compared to any other product in the area with more or less 24-hour acid control, 96% acid control, and that's unique within the market. That's what needed actually to help the severe patient and actually meet the unmet medical need here. As I said, now we are very excited. In weeks or months, we will have the results from our first pivotal trial, and that of course, it's a very interesting milestone for us also from a development point of view, but also from a commercial point of view. With that said, I open up for Q&As. Thank you. Do you have any questions in the room? Natasha just needs to find the microphone. We'll start. Yeah. Then we'll go to you. You go ahead, sir. Exactly. Thank you for the presentation. I think my main question, I am a medical doctor, and certainly these types of drugs, at least in our area in Belgium, are one of the most overprescribed drugs in the entire medical industry. What I'm trying to understand is how accurate maybe are those data of 10 million patients. Is that based on the prescription of the current patients? Because in Belgium, certainly a lot of these people end up once on a PPI and just stay on the PPI. Yeah. The data is based on epidemiological data. That's definitely the 10 million is part of the severe population. You can always say that something is overprescribed. Of course, it's a matter of the demand from the patients, of course, but this is not a mild disease. We are talking about the severe erosive GERD patients with full erosions in the esophagus, frying up the mucosa there. This is the most severe patients. If they are not healed, then of course, there is a risk of progressing the disease into other more severe. This is not an OTC drug compared to— Can I follow up on this? Yes, absolutely. Because that's interesting, because it changes the complete business dynamics of this drug. Because the PPIs, they are given or prescribed for many years often, meaning that you can offer them for a very low price if you're a pharmaceutical company. If you're indeed treating a very severe disease, probably you have a protocol where it's only being prescribed for a limited amount of time, and it also changes the economics for your return. How do you look at that? Well, we have seen the first PCABs been launched in the U.S. now, and the healing course is approximately $ 1,200. Then, of course, it's on top up with a maintenance treatment in average four or five months, in average. Of course, these patients are relapsing when they finish their maintenance, so there will be more healing courses coming up. But of course, we need to also study the maintenance treatment in the next trial as well, where we will include six months of treatment. Natasha. It's very interesting that you secured a European commercial partner. Was it Zentiva? Yes. Pretty early before even the readout. Why did they commit so early? What would you say about the positioning of this drug? Yeah. Well, of course, you can imagine they were owned by Advent, one of the biggest private equity company in the world. You can imagine their due diligence when they went through our database. What they saw then in Europe, as you mentioned here, PPIs are very, very cheap drugs, and they are used OTC. If you are going to have a price reimbursement here in Europe, then of course you need to develop as much distance between yourself and the PPIs. We are the only PCAB can actually offering that. What we see in our phase II is already there, showing superiority with a very minor population. This is very potent drug and that what they saw, obviously, and that's what they invested in. Thank you so much, Christer.
Loading workspace