Welcome to Cinclus Pharma Q2 report 2026. For the first part of the conference call, the participants will be in listen-only mode. During the questions- and- answers session, participants are able to ask questions by dialing pound key five on their telephone keypad. Now I will hand the conference over to CEO Christer Ahlberg and CFO Magnus Christensen. Please go ahead. Thank you, and hi, everyone, and welcome to Cinclus Pharma second quarter 2026 earnings call. I am Christer Ahlberg, and I am CEO of Cinclus Pharma, and with me here today, I have also our CFO, Magnus Christensen. We will walk you through the key developments from the second quarter, after which we will be happy to answer any questions you may have. Our lead asset, linaprazan glurate, is the next generation PCAB, and that substance offers sustained around-the-clock acid control that distinguishes from the current standard of care with the proton pumps inhibitors, the PPIs, and also all other PCABs available in the market and also in the development in the market. It is also for severe erosive GERD. This patient population we are addressing is large and underserved. Roughly 10 million people across the U.S. and Europe live with severe erosive GERD, and a substantial share of them are not adequately healed or treated by today's standard of care. This makes this a specialty driven commercial opportunity rather than a primary care one. Better healing and better symptom control translate directly into clinical and commercial differentiation, and that is our goal. Our phase III program, HEEALING1, began in September 2025, and I am very pleased to report that it has completed enrollment total now. In early July, we announced that we had exceeded protocol-specified target number of patients. So that was a very good news for us. HEEALING1 top-line results are expected in the fourth quarter, already communicated before of this year, which, of course, could give us a potential major value inflection point for the company. Our program is de-risked at this stage. We have a robust clinical data package alignment, both from the U.S. FDA and the European EMA, our regulatory strategy. We have a well-defined CMC plan which we already have communicated before. Linaprazan glurate has, in 2026, been launched in China as planned through our Sinorda licensing agreement and also through their partner HuaDong, which is the 10th second biggest pharma company in China. We are restricted to give any details on that about the launch at this stage. But of course, it looks very promising and good, and we are progressing very well during the launch in China. We are, of course, excited that we have seen the first commercial launch of linaprazan glurate globally, and it is, of course, a very important validation of the drug. We see that the first generation PCABs are rapidly gaining traction. PCABs are now available in more than 30 countries globally, and local treatment guidelines increasingly adopting recommendations, and that is of course very good for us. There is no doubt that the PCABs are about to take over the market from the current standard treatment with proton pumps inhibitors like Losec and Nexium and other products in that group. If you look into the enrollment complete of the phase III study, we are very pleased that with the execution of the first phase III study, HEEALING1, that has developed according to our plans since the start last fall. We announced in early July that our enrollment in the study was completed. At that time, we had randomized 521 patients, exceeding our protocol-specified target of 501 patients. The total number of patients in the study now is actually 523 patients, and the study is being conducted across eight European countries. The primary endpoint is superiority to lansoprazole. That is unique primary endpoint, and we are going to deliver it in healing of the severe erosive GERD patients, the LA grade C and D. We are going to deliver that after four weeks of treatment. Key secondary endpoints cover healing, of course, and symptom relief through four weeks but also through eight weeks for both C and D patients but also, of course, all patients, so all grades as well, A, B, C, and D. The study will be followed by our second and final phase III study, HEEALING2, that will also evaluate maintenance therapy and will be done at clinical sites in both Europe and in U.S. as well. HEEALING2 is planned to initiate following HEEALING1 top-line results. This slide highlights our HEEALING1 progress. We screened the last patient in June and reached enrollment target randomized last patient in July. The remaining milestones prior the top line results. Our last patient treated that we expect within a few weeks, and also the last patient last visit expected to be in September, October this fall, which will end the clinical phase. Thereafter, the remaining steps will be data cleaning and database lock and final readout that we expect during the fourth quarter of the year. We have good visibility over the remaining timeline of the study. This slide you have seen before, but it is very important. It shows how well a drug controls gastric acid over a 24 hours day predicts how well it heals the erosive GERD patients. The relationship is linear, as you can see, whether you look at PPIs or PCABs. That is the central scientific argument for the linaprazan glurate at this stage. Acid control is the biomarker that drives healing in this disease. The more of the day, the 24 hours, you can keep gastric pH above 4, the better it is for the patients. That is precisely the variable on which linaprazan glurate is differentiated, but also what we have had as an aim and objective when we have developed the product from the beginning. This slide illustrates a number of hours pH in the stomach is below pH 4, which different treatment, giving the treatment alternatives available in the market and over the decades and the history of the development of these kind of drugs. With the old H2 blockers, you can see to the left, such as Zantac, that were launched during the 1970s. pH was below 4 during 16 hours per day, but still it was a dramatic improvement compared to have nothing. This drug became the most sold drug in the world and actually built Glaxo to the big pharma company as it is today. Looking into the development into the next step, for the PPI that came to the market in the end of the 1980s and the beginning of the 1990s. Here you can see a reduction between 7- 14 hours, with PPIs, below pH 4. As you have known, these drugs, Losec, Prilosec, Nexium, became the most sold drug in the world at the same time. That actually built Astra and AstraZeneca to what it is today. These drugs are important for companies and when they are developing the company. When we see now the next step in this evolution, you see that the first generation of PCABs were launched in 2015, and now in 2024 in U.S., where you can see that you drop, you have another dramatic step downwards in hours of pH below 4. What they managed to do in Japan, where it was launched first, was to became the most sold drug in Japan. With a close to $1 billion in sales only there. Of course, acid control improvement matter to actually build the market and to build companies launching these kind of products. What you now can see then is our studies show that linaprazan glurate have a uniqueness to deliver pH below 4 only one hour per day. This is a major improvement to all existing treatment alternatives on the market and in the development, highlighting a significant market potential, as you understand them. This is really the end of the treatment ladder, you can say. Now you have reached the goal that also can help the severe ill patients. Also, if you remember the slide I showed you before with the biomarker relating the linear correlation between acid control and healing of these patients. We also wanted to control this and double-check if it works also for PCABs. The last study that has been performed, the phase III trials being performed in U.S. and Europe, with vonoprazan, tegoprazan, and they have used the same comparator of the PPI lansoprazole. If you start from the beginning here with the acid control of each of these drugs, lansoprazole, it's actually interesting to see. When you plot in these results into the curve that we've shown you before, the biomarker curve, it's perfectly spot on related also to this curve. If you actually look at the acid control of lansoprazole is 63% after eight weeks. In the results of the clinical studies of the phase III clinical studies of tegoprazan and vonoprazan in U.S. and Europe, they came to conclusion of 68%-72%. That's perfectly on the line of the biomarker line here, showed you before. Going further then into the tegoprazan, they have acid control of 75%, and actually their clinical data showed 83% in the phase III trial after eight weeks of C and D patient. If you just compare 75% into this curve, you see it's perfectly on the line of 80+% in healing. Looking into the vonoprazan, they have a little bit higher acid control, up to 85%. If you look at their clinical data from the phase III, they have 91.7% of the C and D patients healing after eight weeks, and it is also perfectly spot on the curve as well. You can really predict outcomes with this data, with this curve. Therefore, it is very interesting to see that we have 96%, and it will be very interesting to follow our healing rates after eight weeks for the C and D patients coming to the end of the year. Then we know absolutely in our phase III trial. Of course, our ambition is to have in absolute figures also the best healing rates for the C and D patients, but not only the best healing rates, we also will look into, thanks to our unique acid control. We also want to have the biggest effect difference compared to the PPIs, the biggest delta as we call it. We in our phase II trial delivered 55% delta in absolute percentage figures, 93% versus 38% of the PPIs. That is 55% units in difference. If you look into the other PCABs, they have delivered something between 15%-20% delta versus the same comparative lansoprazole after two and eight weeks. Of course, we want to have the best healing rates, but we also want to deliver the best delta, the effect difference between ourself and the PPI that we are comparing with. That is the same as vonoprazan and tegoprazan has done. So we will have a uniqueness in reaching the best in class positioning here. On top of that, we also want to deliver superiority in symptom relief versus the PPI, which both in daytime symptoms but also in nighttime symptoms. If we can do that, which we have good chance to do, this could definitely be a game changer and a unique position, best in class position that no one has delivered before. That is, of course, something that we have tried, and that is, of course, done thanks to the uniqueness of our acid control. That was the aim from the beginning when we developed this product from the very beginning, that we should have total acid control, which also could have a chance to help the most severe patients. Okay, I think I stop there, and then let us go into some financials, and I hand over then to you, Magnus. Thank you, Christer. If we are turning to our second quarter results we ended the quarter two with a cash balance of SEK 388 million, which is including the structure financing agreement drawn under the Claret facility in quarter one this year. The cash flow in the quarter amounts to SEK -88 million which reflects the continued focus on this investment on HEEALING1 execution and its upcoming milestones. The R&D expenses remain the clear driver of our cost base at 89% of operating expenses in quarter two, compared with the average of 87% over the prior [inaudible] quarters. If you are looking at the year-over-year comparison for Q2, net sale was almost SEK 2 million, and the revenue consisted primarily of the license income from the Zentiva partnership for conversation of linaprazan glurate in Europe. The revenue from Zentiva deal, which include an upfront payment of EUR 30 million in Q2 2025, is being periodized across the phase III studies. Operating expenses were SEK 96 million, driven by the ongoing phase III study activity. EBIT was SEK -95 million, reflecting the higher R&D expenses associated with the full phase III execution. If you look on the financial net line, we recorded SEK 16.3 million, and that is consisting mainly the revaluation of the structured financing of the Claret facility, as well as interest in bank and the interest payments to Claret facility mainly. Net loss for a quarter was almost SEK 79 million, and is driven by the high R&D expenses from the ongoing phase III study. If we look at the balance sheet, we have the non-current asset has increased, and that is primarily reflecting the leasing liabilities for the new office premises. Other current assets decreased mainly due to prepayments to the CRO, and that is in line with the contract that we have. Cash decreased by SEK 200 million, with the SEK 86 million structured financing drawdown partially offsetting the increased R&D expenses as the phase III activity ramped full execution. Non-current liabilities decreased by almost SEK 30 million, mainly representing the contract liability from the Zentiva deal, which is periodized beyond one year. The current liabilities increased by SEK 100 million, and are primarily driven by the structured financing in debt, convertibles and warrants, plus the short-term contract liability from the Zentiva deal. With this, I will hand back over to Christer. Okay. Thank you, Magnus. Thank you for these figures. That brings us to the end of our formal remarks. Before we open the line for questions, a few important dates ahead. The Q3 results will be reported on November 11th this year, and the Q4 results will be reported on February 17th next year, 2027. Of course, we look forward to keeping you updated on the remaining steps of the HEEALING1 study and results of the fourth quarter of this year, the defining clinical milestones ahead for the company. With that, I would like to open the line for questions. Operator, please go ahead. If you wish to ask a question, please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key six on your telephone keypad. The next question comes from Clemence Thiers from Stifel. Please go ahead. Hi. Thanks for the presentation, and thanks for taking my question. I have one on HEEALING1. You ended up randomizing 523 patients versus 501. Was it simply because there was patient being still in screening when you reached the target, or was that a deliberate decision, and does it have any meaningful impact on that stat signal in the end? It is a very easy question. We had patients still in screening when we reached it, and of course, from an ethical point of view, you want to give all patients the possibility to be enrolled. Nothing on that. Okay. That makes sense. Maybe just a second on HEEALING2. You have started preparing for the trial. How much of the work can be done before the HEEALING1 readout? I guess the question being how quickly after the result could you start the trial and enrolling patients? Well, of course, what we could do and what we do now is that we are preparing the protocol for the studies. We are working with picking the right CRO. We are having the requests out there. Then, of course, we have also dialogue with the authorities. We make sure that we have everything in place as fast as possible so you can do it as seamless as possible. That is what we are working on now. The more we can do now, the faster it will go thereafter, after the results of the HEEALING1. Also one advantage is that we have now, of course, is as you have seen, we have executed this HEEALING1 study very fast. Recruitment time of nine months, I would say, more than 500 patients. We have a very good collaboration with both the CRO in this case, but also we have picked the right sites. We know the high delivery sites here and the high performers. That, of course, is good for the feasibility of selecting the sites also in the next study, which makes it maybe, hopefully, and that is our ambition, to have a more flying start with higher recruitment early stage in the study. Otherwise, normally it takes some long time before you are up and running with the sites and recruitment. That is also the answer on your first question, that when you are up and running and having many sites very actively, they recruit a lot of patient in the end of the studies. We want to have this recruitment pace as early as possible also for HEEALING2. Okay. Thank you very much. That is all from me. The next question comes from Arvid Necander from DNB Carnegie. Please go ahead. Good morning, and thanks for taking my questions. The first question is on HEEALING1. Now that enrollment is complete, how much visibility do you have on the available patient population, including discontinuations, protocol deviations, and disease severity splits on central review? I guess in summary, has all of this been broadly in line with your assumptions when you powered the study? My second question is on HEEALING2. How much of the protocol is now effectively done? Aside from selecting a single dose and enrolling patients both in the United States and in Europe, are there any significant changes in the study design versus HEEALING1? Those are my questions. Thanks. Okay. Yeah. The first question is, of course, a little bit early to say yet. Now, of course, still it is blind as we have no insight on results or anything like that, as you know. That is totally blind, and then we will not know anything about that before we have the results in Q4. When it comes to other things, everything so far, we should say that we have not closed the database yet. The study is still ongoing, so we do not have all data yet when it comes to the groups and discontinuation and things like that. We will have the last treated patient, as I mentioned, in a couple of weeks here. Nevertheless, it looks like everything goes according to plan, as what we can see now and what I can say now. That is the first question. Next question is you asked, Arvid, regarding the differences between HEEALING1 and HEEALING2. More or less, I would say, and I think it is important for everyone to understand, the outcome of this study is definitely the value inflection point. The outcome of this study is what we foresee and also will happen in the HEEALING2 study because the protocol will look very similar to each other. Of course, it might be that we fine-tune anything based on the results that we get. Overall, we do not expect to have any other outcome in the HEEALING2 versus the HEEALING1. From an analyst point of view, I would say the HEEALING1 study is the most important value inflection point. In the HEEALING1, we have two doses of linaprazan glurate patients. In the HEEALING2, our ambition is to go with only one dose. That might be the biggest difference. Otherwise, the endpoints will look similar and what we are measuring. Definitely, we do not expect to see any differences here. Did that answer your question? Okay. Let us go to other questions. Are there other questions from the audience? As a reminder, if you wish to ask a question, please dial pound key five on your telephone keypad. Okay. I think we have also some written questions which I can cover. There is a question regarding the cost of HEEALING1, if all the cost has been taken now, so the rest cash can be used for the preparation of HEEALING2. Yes. Well, no, everything is not taken yet. We have already communicated that we have cash into Q3 next year, and then including that is, of course, all costs for HEEALING1, but also some of the preparation for the HEEALING2. That is already communicated, and everything goes according to plan. Also, thoughts regarding NASDAQ listing. I assume that means in U.S. Of course, this is something that you always have in mind, especially depending on if you're going to have a commercialized yourself in U.S., then of course, that could be a solution. But there are no decisions or anything on that yet. That's much too early for us to say anything about now. We have another question regarding if the results of HEEALING1 will have any impact on the design of the scope of HEEALING2. It's actually the same question as Arvid just had raised. I would say, of course, it could be fine-tuned, but overall, it's more or less the same design, with the exception that we would like to reduce one dose of the linaprazan glurate. Reduce one of the dosing arms, so only one dosing arm. Then we had another question regarding vonoprazan, if they cannot just deliver twice daily or three times daily to overcome the 24 hours gap as a control. Well, it's not that easy, I have to say. Firstly, what we could say is that we have a better acid control once daily compared to what vonoprazan has. So we have the best acid control overall. What we also see, though, if they try to split their dose into two times per day, they don't gain anything, what we have seen in their own studies. Meaning that there is no reason to split the dose for them. This once daily dose is what they have used in the clinical trials and what they have used in the registration as we have now and what they are approved for. We see that when we split the dose though, if we have 100 mg as once daily, if we split that into 50 times two, even though once daily we are outperforming the other PCABs with acid control, and if we split the dose, we also gain quite a lot during the acute phase. What we do, again, is of course that we have a smoother acid control over the 24 hours, but we also make sure that we push all the patients above pH 4 24 hours, not only the easy-to-treat patients. We also push up the difficult-to-treat patient. The most severe patients that really suffer from this disease, we actually can have a chance to help them as well. That's unique. We have not seen anyone that can actually help these patients doing that with the product. Actually, the severe patients is also the patient group that definitely have the unmet medical need. This is not only a patient that suffer and complaining about some mild heartburns once in a while after a bar round in the day before. This is patient that really suffer from this. They have day-to-day business. Their quality of life is very, very low. They cannot sleep during nighttime. Also, they have a risk of progressing into cancer if they do not heal, these patients. This is a patient that really suffer from that acidic content in the stomach going up in the esophagus and really frying up the mucosa there. This is nothing to be compared with some mild heartburn that some actually might think that this disease is about. This is a really tough disease, have a huge impact on quality of life, and actually risking the patient's long-term health, and actually a risk of progressing into cancer. This patient population is the patients that we want to help with this drug. We have a chance, actually, once for all, to help this patient that no one has done before. Okay. Any other questions after today meeting? Otherwise, I will stop there, and thank you for the time. I am really looking forward coming back to you during Q4 with the results of our phase III trial. Let us stay in touch. Thank you very much for today meeting.
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