Q2 2026 Cinclus Pharma Holding publ AB Earnings Call

August 19, 2026

Speaker #2: Your line is muted.

Speaker #3: Call recording is on.

Speaker #4: Welcome to the Cinclus Pharma Q2 report 2026. For the first part of the conference call, participants will be in listen-only mode. During the Q&A session, participants are able to ask questions by dialing #5 on their telephone keypad.

Operator 2: 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 #5 on their telephone keypad. Now I will hand the conference over to CEO Christer Ahlberg and CFO Magnus Christensen. Please go ahead.

Operator: 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.

Speaker #4: Now I will hand the conference over to CEO Krister Ahlberg and CFO Magnus Christensen. Please go ahead.

Speaker #5: Thank you, and hi, everyone, and welcome to Cinclus Pharma's second quarter 2026 earnings call. I am Krister Ahlberg, and I'm CEO of Cinclus Pharma. With me here today, I also have our CFO, Magnus Christensen.

Christer Ahlberg: 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.

Speaker #5: 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.

Speaker #5: Our lead asset: Lina Proton Lurate, is the next-generation PCAB, and we offer and that substance offers sustained around-the-clock asset control that distinguishes it 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.

Speaker #5: And it's also for severe erosive GERD. This patient population we are addressing is large and underserved. Roughly 10 million people across the US 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.

Christer Ahlberg: Roughly 10 million people across the US 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 Q4, 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.

Speaker #5: 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's our goal.

Speaker #5: Our Phase 3 program, Healing One, began in September 2025, and I'm very pleased to report that it has now completed total enrollment. In early July, we announced that we had exceeded the protocol-specified target number of patients.

Speaker #5: So that was very good news for us. Healing One top-line results are expected in the fourth quarter, as already communicated before, of this year, which of course could give us a potential major value inflection point for the company.

Speaker #5: Our program is de-risked at this stage. We have a robust clinical data package, and alignment from both the US FDA and the European EMA regarding our regulatory strategy.

Christer Ahlberg: We have a robust clinical data package alignment, both from the US 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 biggest pharma company in China. We are restricted to give any details on that about the launch at this stage. 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. It's, of course, a very important validation of the drug. We see that the first generation PCABs are rapidly gaining traction.

Speaker #5: And we have a well-defined CMC plan, which we already have communicated before. Lina Proton Lurate has, in 2026, been launched in China, as planned, through our Synarda licensing agreement, and also through their partner Huadong, which is the second biggest pharma company in China.

Speaker #5: We have also been restricted from giving any details 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.

Speaker #5: And we are, of course, excited that we have seen the first commercial launch of Lina Proton Lurate globally. And it's, of course, a very important validation of the drug.

Speaker #5: 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 are increasingly adapting recommendations.

Christer Ahlberg: PCABs are now available in more than 30 countries globally, and local treatment guidelines increasingly adopting recommendations. That's, 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 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, and 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 8 European countries.

Speaker #5: And that's, 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 pump inhibitors, like Losec and Nexium, and other products in that group.

Speaker #5: If you look into the enrollment completed for the Phase 3 study, we are very pleased with the execution of the first Phase 3 study, Healing One, which has developed according to our plans since the start last fall.

Speaker #5: We announced in early July that our enrollment in the study was completed, and at that time we had randomized 521 patients, exceeding our protocol-specified target of 501 patients.

Speaker #5: The total number of patients in the study now is actually 523, and the study is being conducted across eight European countries. The primary endpoint is superiority to lansoprazole.

Christer Ahlberg: The primary endpoint is superiority to lansoprazole. That's unique primary endpoint. We're going to deliver it in healing of the severe erosive GERD patients, the LA grade C and D. We're going to deliver that after 4 weeks of treatment. Key secondary endpoints cover healing, of course, and symptom relief through 4 weeks, but also through 8 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 US 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.

Speaker #5: That's the unique primary endpoint, and we're going to deliver it in healing of the severe erosive GERD patients, the LA grade C and D. And we're going to deliver that after four weeks of treatment.

Speaker #5: Key secondary endpoints cover healing, of course, and symptom relief through four weeks, but also through eight weeks—for both C and D patients, and, of course, all patients.

Speaker #5: So all grades as well: A, B, C, and D. The study will be followed by our second and final Phase 3 study, Healing Two, that will also evaluate maintenance therapy, and will be done at clinical sites in both Europe and in the US as well.

Speaker #5: Healing Two is planned to initiate following Healing One top-line results. This slide highlights our Healing One progress. We screened the last patient in June and reached the enrollment target, randomizing the last patient in July.

Speaker #5: The remaining milestones prior to the top-line results are: last patient treated, which we expect within a few weeks, and also last patient last visit, expected to be in September or October, this fall.

Christer Ahlberg: The remaining milestones prior the top line results are 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 Q4 of the year. We have good visibility over the remaining timeline of the study. This slide you have seen before, but it's 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 at this stage. Acid control is the biomarker that drives healing in this.

Speaker #5: Which will end the clinical phase. Thereafter, the remaining steps will be data cleaning and database lock, and the final readout, which we expect during the fourth quarter of the year.

Speaker #5: We have good visibility over the remaining timeline of the study. This slide you have seen before, but it's very important. It shows how well a drug controls gastric acid over a 24-hour day and predicts how well it heals the erosive GERD patients.

Speaker #5: The relationship is linear, as you can see, whether you look at PPIs or PCABs. That is the central scientific argument for the Lina Proton at this stage, as its control is the biomarker that drives healing in.

Speaker #5: And the more of the day—the 24-hour period—you can keep gastric pH above 4, the better it is for the patients. And that is precisely the variable on which linaprazan glurate is differentiated, but also what we have done—what we have had as an aim and objective when we have developed the product from the beginning.

Christer Ahlberg: And 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 kinds of drugs. With the old H2 blockers, you can see to the left, such as Zantac, that were launched during the '70s. pH was below 4 during 16 hours per day, but still it was a dramatic improvement compared to have nothing.

Speaker #5: This slide illustrates the number of hours the pH in the stomach is below pH 4, with different treatments, giving the treatment alternatives available in the market and over the decades, and the history of the development of these kinds of drugs.

Speaker #5: With the old H2 blockers, you can see to the left, such as Zantac, that were launched during the '70s, pH was below 4 during 16 hours per day.

Speaker #5: But still, it was a dramatic improvement compared to having nothing. And this drug became the most sold drug in the world, and actually built Glaxo into the big pharma company it is today.

Christer Ahlberg: 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 proton pumps inhibitor that came to the market in the end of '80s and the beginning of '90s. Here you can see a reduction between 7 to 14 hours with PPIs below pH 4. As you have known, these drugs Losec, Prilosec, NEXIUM, became the most sold drug in the world the same time. That actually built Astra and AstraZeneca to what it is today. So these drugs are important for companies and when they are developing the company.

Speaker #5: Looking into the development and the next step for the proton pump inhibitors that came to the market at the end of the '80s and the beginning of the '90s, you can see here a reduction between 7 to 14 hours with PPIs below pH 4.

Speaker #5: And that, as you have known, these drugs—Losec, Prilosec, Nexium—became the most sold drugs in the world at the same time. And that actually built Astra and AstraZeneca toward what it is today.

Speaker #5: So these drugs are important for companies, and when they are developing the company. And also, 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 the US.

Christer Ahlberg: Also 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 the US, where you can see that you have another dramatic step downwards in hours of pH below 4. Actually, what they managed to do in Japan, where it was launched first, was to become the most sold drug in Japan. With close to $1 billion US in sales only there. So 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.

Speaker #5: Where you can see that you drop, you have another dramatic step downwards in hours of pH below 4. And actually, what they managed to do in Japan, where it was launched first, was to become the most sold drug in Japan.

Speaker #5: And with close to $1 billion in sales only there. So, of course, acid control improvement matters to actually build the market and to build companies launching these kinds of products.

Speaker #5: And what you now can see then is our studies show that linaprazan glurate has a unique ability to deliver pH below 4 for only one hour per day.

Christer Ahlberg: 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 that. 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 and the last study that has been performed, the phase III trials being performed in US 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 is actually interesting to see.

Speaker #5: This is a major improvement over all existing treatment alternatives on the market and in development, highlighting a significant market potential, as you understand it.

Speaker #5: This is really the end of the treatment ladder, you could say. I mean, now you have reached the goal that also can help the severely ill patients.

Speaker #5: And also, if you remember the slide I showed you before with the biomarker relating the linear correlation between acid control and time, and healing of these patients.

Speaker #5: We also wanted to control this and double-check if it works also for PCABs. And the last studies that have been performed, the phase 3 trials, have been performed in the US and Europe with vonoprazole, tegoprazole, and they have used the same comparator of the PPI, lansoprazole.

Speaker #5: And if you start from the beginning here with the acid control of each of these drugs, lansoprazole is actually interesting to see. When you plot these results into the curve that we showed you before, the biomarker curve, it’s spot on.

Christer Ahlberg: When you plot in these results into the curve that we showed you before, the biomarker curve, it is perfectly spot on related also to this curve. If you look at the acid control of lansoprazole, it is 63% after 8 weeks. In the results of the phase III clinical studies of tegoprazan and vonoprazan in US and Europe, they came to conclusion of 68% to 72%. That is perfectly on the line of the biomarker line here, showed you before. Going further then into the tegoprazan, they have acid control of 75%. Actually, their clinical data showed 83% in the phase III trial after 8 weeks of the C and D patient. If you just compare 75% into this curve, you see it is perfectly on the line of 80-plus percent in healing.

Speaker #5: It's perfectly spot-on, related also to this curve. So if you actually look at the acid control of Lansoprazole, it's 63% after eight weeks.

Speaker #5: And in the results of the clinical studies—the phase 3 clinical studies—of tegoprazole and vonoprazole in the US and Europe, they came to a conclusion of 68 to 72%.

Speaker #5: And that's perfectly on the line, which is the biomarker line here I showed you before. Going further then into the Tegoprazole, they have an acid control of 75%.

Speaker #5: And actually, their clinical data showed 83% in the Phase 3 trial after eight weeks for the CND patient. And if you just compare 75% to this curve, you see it's perfectly on the line of 80-plus percent in healing.

Speaker #5: And also, looking into the vonoprazan, they have a little bit higher acid control—up to 85%. And if you look at their clinical data from the Phase 3, they have 91.7% of the CND patients healing after eight weeks.

Christer Ahlberg: Also looking into the vonoprazan, they have 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 8 weeks. It is also perfectly spot on the curve as well. You can really predict outcomes 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 8 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.

Speaker #5: And it's also perfectly spot-on the curve as well. So you can really predict outcomes with this data, with this curve. And therefore, it's very interesting to see that we have 96%, and it will be very interesting to follow our healing rates after eight weeks for the CND patients coming to the end of the year, when we know absolutely in our Phase 3 trial.

Speaker #5: But of course, our ambition is to have in absolute figures also the best healing rates for the CND 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.

Christer Ahlberg: 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, where 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% to 20% delta versus the same comparator, lansoprazole, after 2 and 8 weeks. Of course, we want to have the best healing rates, but we also want to deliver the best delta, the effect difference between ourselves and the PPI that we are comparing with, and that is the same as vonoprazan and tegoprazan has done. We will have a uniqueness in reaching the best-in-class positioning here.

Speaker #5: Where we, in our Phase 2 trial, delivered a 55% delta in absolute percentage figures—93% versus 38% for the PPIs. That’s 55 percentage units in difference.

Speaker #5: If you're looking into the other PCABs, they have delivered something between 15% to 20% delta compared to the same comparator, lansoprazole, after two and eight weeks.

Speaker #5: And of course, we want to have the best healing rates, but we also want to deliver the best delta—the effect difference between ourselves and the PPI that we're comparing with.

Speaker #5: And that's the same as what vonoprazole and tegoprazole have 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, both in daytime symptoms and in nighttime symptoms.

Christer Ahlberg: On top of that, we also want to deliver superiority in symptom relief versus the PPI, 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 asset 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 them to you, Magnus.

Speaker #5: And if we can do that, which we have good chances to do, this could definitely be a game changer and a unique position—best-in-class position—that no one has delivered before.

Speaker #5: And 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.

Speaker #5: Okay, I think I'll stop there. Let's go into some financials, and I'll hand over to you, Magnus.

Speaker #1: Thank you, Christer. If we turn to our second quarter results, we ended Q2 with a cash balance of SEK 388 million, which is included in the structured financing agreement drawn under the clarified facility in Q1 this year.

Magnus Christensen: Thank you, Christer. If we are turning to our Q2 results. We ended Q2 with a cash balance of 388 million SEK, which is included in the structural financing agreement drawn under the Claret facility in Q1 this year. The cash flow in the quarter amounts to -88 million SEK, which reflects the continued focus and on this investment on HEEALING1 execution and its upcoming milestones. The R&D expenses remain the clear driver. Our cost base at 89% of operating expenses in Q2, compared with the average of 87% over the prior four quarters. If you are looking at the year-over-year comparison for Q2, net sales were almost 2 million SEK, and the revenue consisted primarily of the license income from the Zentiva partnership for conversion of linaprazan glurate in Europe.

Speaker #1: The cash flow in the quarter amounts to minus 88 million SEK, which reflects the continued focus and investment on Helicon-1 execution and its upcoming milestones.

Speaker #1: R&D expenses remain the clear driver of our cost base at 89% of operating expenses in Q2, compared with an average of 87% over the prior four quarters.

Speaker #1: And if you're looking at the year-over-year comparison for Q2, let's say almost SEK 2 million, and the revenue consists primarily of the license income from the Centiva partnership.

Speaker #1: For the conversation of Linoprazole Durate in Europe, the revenue from the Centiva deal, which includes an upfront payment of €13 million in Q2 2025, is being periodized across the Phase 3 studies.

Magnus Christensen: The revenue from Zentiva deal, which include an upfront payment of 30 million EUR in Q2 2025, is being periodized across the phase III studies. Operating expenses were 96 million SEK, driven by the ongoing phase III study activity. EBIT was -95 million SEK, reflecting the higher R&D expenses associated with the full phase III execution. If you look on the financial net line, we recorded 16.3 million SEK, and that is consistently duration of the structuring of the Claret facility as going from cash in bank and the interest payments to Claret facility mainly. Net loss for the quarter was almost 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.

Speaker #1: Operating expenses were SEK 96 million, driven by the ongoing Phase 3 study activity. EBIT was minus SEK 95 million, reflecting the higher R&D expenses associated with the full Phase 3 execution.

Speaker #1: And if you look at the financial net line, we recorded SEK 16.3 million, and that's consisting mainly of the duration of the structure of the facility.

Speaker #1: This comes from cash in bank and the interest payments, to clarify facility mainly. Net loss for the quarter was almost SEK 79 million, and it's driven by the higher R&D expenses from the ongoing phase 3 study.

Speaker #1: And if we look at the balance sheet, we see that the non-current assets have increased. That's primarily reflecting the leasing liabilities for the new office premises.

Speaker #1: Other current assets decreased, mainly due to prepayments to the CRO, and that's in line with the contract that we have. Cash decreased by $200 million.

Magnus Christensen: 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 200 million, with the 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 30 million, mainly representing the contract liability from the Zentiva deal, which is periodized beyond one year. The current liabilities increased by 100, and they 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 hand back over to Christer.

Speaker #1: With the $86 million structured financing drawdown, partially offsetting the increased R&D expenses as the Phase 3 activity ramped to full execution. Non-current liabilities decreased by almost $30 million.

Speaker #1: Mainly representing the contract liability from the Centiva deal, which is periodized beyond one year. And the current liabilities increased by 100, and that's primarily driven by the structured financing in debt convertibles and warrants.

Speaker #1: Plus the short-term contract liability from the Centiva deal. And with this, I hand back over to Christer.

Speaker #2: Okay. Thank you, Magnus. Thank you for these figures. And that brings us to the end of our formal remarks. Before we open the line for questions, a few important dates ahead:

Christer Ahlberg: Okay. Thank you, Magnus. Thank you for those 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 11 November this year, and the Q4 results will be reported on 17 February 2027. Of course, we look forward to keeping you updated on the remaining steps of the HEEALING1 study and results of the Q4 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.

Speaker #2: The Q3 results will be reported on November 11th this year, and the Q4 results will be reported on February 17th next year, 2027. And, of course, we look forward to keeping you updated on the remaining steps of the Healing One study.

Speaker #2: 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.

Speaker #3: 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.

Operator 2: If you wish to ask a question, please dial #5 on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial #6 on your telephone keypad. The next question comes from Clémence Thiers from Stifel. Please go ahead.

Operator: If you wish to ask a question, please dial #5 on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial #6 on your telephone keypad. The next question comes from Clémence Thiers from Stifel. Please go ahead.

Speaker #3: The next question comes from Clemens Thierre from Stiefel. Please go ahead.

Speaker #4: Hi, thanks for the presentation and thanks for taking my question. I have one on Healing One. So, you ended up randomizing 523 patients versus 501.

Clémence Thiers: 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 stat sign in the end?

Speaker #4: Was it simply because I 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 static in the end?

Speaker #2: It's a very easy question. We had patients still in screening when we reached it. And of course, you want to give—I mean, from an ethical point of view—you want to give all patients the possibility to be enrolled.

Christer Ahlberg: 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.

Speaker #2: So nothing more than that.

Clémence Thiers: Okay

Christer Ahlberg: Nothing more than that.

Speaker #4: But that makes sense. And maybe just a second on Healing Two. So you've started preparing for the trial. How much of the work can be done before the Healing One readout?

Clémence Thiers: 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?

Speaker #4: And I guess the question is, how quickly after the result could you start the trial and begin enrolling patients?

Speaker #2: Well, I mean, of course, what we could do and what we do now is that we—I mean, we are prepared, I mean, of course, we are preparing the protocol, the—for the studies.

Christer Ahlberg: 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 a 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.

Speaker #2: We are working with, I mean, picking the right CRO. So we have the requests out there, and then, of course, we also have dialogue with the authorities.

Speaker #2: So we make sure that we have everything in place as fast as possible, so you do it as seamlessly as possible. So, I mean, that is what we are working on now.

Speaker #2: And the more we can do now, the faster it will go thereafter, after the results of the Healing One. And also, one advantage that we have now, of course, as you have seen, I mean, we have executed this Healing One study, I mean, very fast.

Speaker #2: Recruitment time of nine months. I would say more than 500 patients. So we have a very good collaboration, both with the CRO in this case and also because we have picked the right sites.

Christer Ahlberg: We have a very good collaboration both to CRO in this case then, but also we have picked the right sites. We know the high delivery sites here and the high performers. That is, of course, good for the feasibility of selecting the sites also in next study, which may make it maybe, hopefully, and that is our ambition is to have a more flying start with higher recruitment early stage in the study. Otherwise, normally it takes some kind of 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 patients in the end of the studies. We want to have this recruitment pace as early as possible also for the HEEALING2.

Speaker #2: So we know the high delivery sites here and the high performers. And that, of course, is good for the feasibility of selecting the sites also in the next study.

Speaker #2: Which makes it maybe, hopefully—and that's our ambition—to have a more flying start with higher recruitment at an early stage in the study. But otherwise, normally, it takes quite a long time before you're up and running with the sites.

Speaker #2: And recruitment. So the most and that's also the question the answer on your first question that when you are up and running, and having many sites very actively, they recruit a lot of patients in the end of the studies.

Speaker #2: So we want to have this recruitment pace as early as possible, also for the Healing II.

Speaker #4: Okay. Thank you very much. That's all from me.

Clémence Thiers: Okay. Thank you very much. That is all for me.

Speaker #3: The next question comes from Arvid Nykatter from DNB Carnegie. Please go ahead.

Operator 2: The next question comes from Arvid Necander from DNB Carnegie. Please go ahead.

Operator: The next question comes from Arvid Necander from DNB Carnegie. Please go ahead.

Speaker #5: Good morning, and thanks for taking my questions. So, the first question is on Healing One. Now that enrollment is complete, how much visibility do you have on the available patient population, including this continuation, protocol deviations, and disease severity splits on central review?

Arvid Necander: 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 States and in Europe, are there any significant changes in the study design versus HEEALING1? Those are my questions. Thanks.

Speaker #5: And I guess, in summary, has all of this been broadly in line with your assumptions when you powered the study? And then my second question is on Healing Two.

Speaker #5: How much of the protocol is now effectively done, and aside from selecting a single dose and enrolling patients both in the States and in Europe, are there any significant changes in the study design versus Healing One?

Speaker #5: Those are my questions. Thanks.

Speaker #2: Okay, yeah. The first question is, of course, a little bit early to say yet. I mean, of course, still, it's blinders—we have no insight on results or anything like that.

Christer Ahlberg: Okay. The first question is, of course, a little bit early to say yet now. Of course, still it's 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, it looks everything so far, we should say that we have not closed the database yet. The study is still ongoing, so we don't 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. That's what we can see now and what I can say now. That is the first question.

Speaker #2: As you know, that is totally blind, and we will not know anything about that before we have the results in Q4. But also, I mean, when it comes to other things, it looks like so far we should say that we have not closed the database yet.

Speaker #2: I mean, the study is still ongoing, so we don't have all the data yet when it comes to the groups and this continuation and things like that.

Speaker #2: We will have the last treated patient, as I mentioned, in a couple of weeks here. But nevertheless, it looks like everything is going according to plan, as far as we can see now and as far as I can see now.

Speaker #2: So that is the first question. Next question is, you asked Arvid regarding the differences between Healing One and Healing Two. And more or less, I would say—and I think it's important for everyone to understand.

Christer Ahlberg: Next question is, you asked, Arvid, regarding the differences between HEEALING1 and HEEALING2. More or less, I would say, and I think it's 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. Of course, what we will do, hopefully, in the HEEALING1, we have two doses of linaprazan glurate patients.

Speaker #2: The outcome of this study is definitely the value inflection point. This outcome of the study is what we foresee and also what will happen in the Healing Two study.

Speaker #2: 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.

Speaker #2: But overall, we do not expect to have any other outcome in the Healing Two versus the Healing One. So, from an analysis point of view, I would say the Healing One study is the most, most important value inflection point.

Speaker #2: I also, of course—I mean, what we will do, hopefully—I mean, in the Healing One, we have two doses of healing of Linna Prasongrate patients.

Speaker #2: In the Healing Two, our ambition is to go with only one dose, so that might be the biggest difference. Otherwise, the endpoints will look similar.

Christer Ahlberg: 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. So definitely, we do not expect to see any differences here. Did that answer your question? Okay. Let's go to other questions. Are there other questions from the audience?

Speaker #2: And what we are measuring, so definitely, we do not expect to see any differences here. Did that answer your question? Okay.

Speaker #2: But let's go to other questions. Are there other questions from the audience?

Speaker #3: As a reminder, if you wish to ask a question, please dial the pound key followed by five on your telephone keypad.

Operator 2: As a reminder, if you wish to ask a question, please dial pound key 5 on your telephone keypad.

Operator: As a reminder, if you wish to ask a question, please dial pound key 5 on your telephone keypad.

Speaker #2: Okay. I think we also have some written questions, which I can cover. There is a question regarding the cost of Healing One—if all now—so the rest of the cash can be used for the preparation of Healing Two.

Christer Ahlberg: 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. So that is already communicated and everything goes according to plan. Also, thoughts regarding Nasdaq listing, I assume that means in US.

Speaker #2: Yes. Well, no, not everything is taken yet. I mean, we have already communicated that we have cash into Q3 next year, and included in that, of course, are all costs for Healing One.

Speaker #2: But also, some of the preparation for the Healing Two is already communicated, and everything is going according to plan. And also, thoughts regarding the Nasdaq listing.

Speaker #2: I assume that means in the US. And we have not—we have, I mean, of course, this is something that you always have in mind.

Christer Ahlberg: We have not. Of course, this is something that we always have in mind, especially depending on if you are going to have a commercialized yourself in US, then of course, that could be a solution, but there are no decisions or anything on that yet. So that is much too early for us to say anything about now. We have another question regarding if the results of HEEALING1 will have an impact on the design of the scope of HEEALING2. It is actually the same question as Aritman just had raised. I would say, of course, it could be fine-tuned, but overall it is 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.

Speaker #2: I mean, especially depending on if you're going to commercialize yourself in the US. And of course, that could be a solution, but there are no decisions or anything on that yet.

Speaker #2: So that's much too early for us to say anything about now. We have another question regarding if the Healing One if the results of Healing One will have an impact on the design of the scope of Healing Two.

Speaker #2: It's actually the same question as Arvid just raised. And I would say, of course, it could be fine-tuned, but overall, it's more or less the same design.

Speaker #2: With the exception that we would like to reduce one dose of the Linna Prasongrate—reduce one of the dosing arms—so that there is only one dosing arm.

Speaker #2: And then we had another question regarding Vonoprazan. If they cannot just deliver twice daily or three times daily to overcome the 24-hour gap as a control.

Christer Ahlberg: Well, we had another question regarding vonoprazan, if they cannot just deliver twice daily or three times daily to overcome the 24 hours gap of acid control. Well, it is 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 do not gain anything, what we have seen in their own studies. Meaning that there is no reason to split the dose for them. Their 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.

Speaker #2: Well, it's not that easy, I have to say. Firstly, what we could say is that we have better acid control once daily, compared to what vonoprazan has.

Speaker #2: So, we have the best acid control overall. What we also see, though, is that if they try to split their dose into two times per day, they don't gain anything.

Speaker #2: What we have seen in their own studies means that there is no reason to split the dose for them. This 24-day, once-daily dose is what they have used in the clinical trials and what they have used in the registration as we have now.

Speaker #2: And what they are approved for. We see that when we split the dose, though, or if we have 100 milligrams as once daily, if we split that into 50 milligrams twice daily, we actually—even though once daily is—we are outperforming the other PCAPs with acid control.

Christer Ahlberg: We see that when we split the dose though, if we have 100 milligrams 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 gain 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 four 24 hours, not only the easy-to-treat patients. We also push up the difficult-to-treat patients, the most severe patients that really suffer from this disease, we actually can have a chance to help them as well. That is unique. We have not seen anyone that can actually help these patients doing that with a product.

Speaker #2: And if we split the dose, we also gain quite a lot. During the acute phase, what we do again is, of course, ensure that we have smoother acid control over the 24 hours.

Speaker #2: But we also reduce that, and we also make sure that we push all the patients above pH 4 for 24 hours, not only the easy-to-treat patients.

Speaker #2: We also push up the difficult-to-treat patients. And most severe patients that really suffer from this disease—we actually can have a chance to help them as well.

Speaker #2: And that's unique. That is, we have not seen anyone that can actually help these patients doing that with the product. And actually, the severe patients are also the patient group that definitely have the unmet medical need.

Christer Ahlberg: 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 low. They cannot sleep during nighttime. Also they have a risk of progressing into cancer if they do not heal, these patients. So 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.

Speaker #2: And this is not only patients that suffer and complain about some mild heartburns once in a while, after a bar round the day before.

Speaker #2: These are patients that really suffer from this. They cannot— they have day-to-day business, but they cannot— the quality of life is very, very low. They cannot sleep during nighttime.

Speaker #2: They also have a risk of progressing into cancer if they don't heal, these patients. So this is a patient that really suffers from the acid, the content in the stomach going up in the esophagus.

Speaker #2: And really frying up the mucosa there. And this is nothing to be compared with some mild heartburn that some actually might think this disease is about.

Speaker #2: This is a really tough disease. It has a huge impact on quality of life and actually risks the patient's long-term health, with the potential of progressing into cancer.

Christer Ahlberg: 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. So 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's 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. So, let us stay in touch. Thank you very much for today's meeting.

Speaker #2: So that these patient population is the patients that we want to help with this drug. And we have a chance, actually, once and for all, to help these patients—something that no one has done before.

Speaker #2: Okay, another question after today's meeting. Otherwise, I will stop there. Thank you for your time, and I'm really looking forward to coming back to you during Q4 with the results of our phase 3 trial.

Speaker #2: So let's stay in touch. Thank you very much for today's meeting.

Operator 1: The host has ended this call. Goodbye.

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