Cinclus Pharma Holding AB (publ) ($CINPHA)

Welcome to Cinclus Pharma Q1 Report 2026. [Operator Instructions] Now I will hand the conference over to CEO, Christer Ahlberg. Please go ahead.

Thank you very much, and hello, and welcome to Cinclus Pharma's first quarter 2026 earnings call. As you already know now, I'm Christer Ahlberg and CEO of Cinclus Pharma. And with me here today, I also have our CFO, Magnus Christensen; and our R&D Director, Margit Mahlapuu. We will walk you through the key developments from the first quarter. Thereafter, we will be happy to answer any questions you may have. So let's go in then directly to the presentation. And as you know, this -- our lead asset, linaprazan glurate, is the next-generation PCAB built around one defining property, sustained around-the-clock acid control that differentiates this substance from both PPIs and from the rest of the PCABs, especially in severe erosive GERD, which is our target population. The patient population we are addressing is a large and underserved, roughly approximately 90 million patients worldwide and 10 million are people or patients from U.S. and Europe. And these patients do have a severe erosive GERD and a substantial share of them are not adequately healed on today's standard of care, including PCABs. The gap is what makes the specialty-driven commercial opportunity rather than a primary care one. Better healing and better symptom control translate directly into clinical and commercial differentiation. So that's important for us. Our Phase III program based on the strong Phase II results we generated previously began in last year in October and our first study, HEEALING 1 has had a very good progress, and we will learn more about that later in this presentation. And as we -- and we actually -- we are approaching full enrollment and -- in this HEEALING 1 study, and we have now good visibility on the time lines with expected top line results in Q4 already in this year. This will, of course, be a major value catalyst. And as I said, Margit will tell you more about this later during this presentation. Our program is well derisked at this stage. We have a robust clinical data package alignment from both FDA and EMA, our regulatory strategy, and we are -- have a very well-defined CMC plan also aligned with the authorities. PCABs are gaining really global momentum, now available in more than 30 countries, and increasingly incorporated into treatment guidelines, which is important, further validating -- I mean, this is further validating the mechanism of action and expanding the long-term commercial opportunity for linaprazan glurate, our substance. We have, as you know, already, a license agreement with Zentiva in Europe worth up to EUR 220 million. And this cooperation works well -- very well. We also have a license agreement with Sinorda for selected markets in Asia. And in fact, as we already have communicated, linaprazan glurate is now launched in China by Sinorda's partner during the Q1. Sinorda partner is HuaDong. And now we have ongoing local reimbursement application. But in the last -- in the end of last year, we actually received the national reimbursement in China. So that's very positive. This chart is a slide makes -- I mean, the chart this makes a simple but important point. I mean we -- how well a drug controls gastric acid over 24-hour, they predicts how well it heal it -- I mean, it will heal the erosive GERD. The relationship is totally linear as you see. It doesn't matter if we're talking about PPIs or other PCABs. The biomarkers is there and the correlation is there for all of these drugs. This is, I mean, a central scientific argument for our program. Our acid control is the biomarker that drives healing in this disease. And the more of the day you can keep the gastric pH above 4, the greater chances you have to heal the patients. And that is precisely the variable and the differentiation factor, which linaprazan glurate is differentiated, how it's positioned and how we have built and developed the product. This slide illustrates the number of hours that pH in the stomach is below pH 4 with different treatment alternatives. You can see the evolution of this -- of the market for decades here, where you start with the H2 blockers. On the top row, you can see the acid control in percentage over the 24 hours, meaning pH above 4. And in the diagram there, you can see the number of hours where you are below pH 4. Below pH 4 gives you -- there is a risk -- each hour you are below, there is a risk that you actually get erosions and symptoms based on the -- I see the content coming up in the esophagus. H2 blockers, 16 hours below pH 4. We had an incremental development when PPI came to the market. You can see the giant leap there. That was the reason why they became so popular and become the most sold drug in the world. We can now see the pH is -- have another giant leap going into the first-generation of PCABs from PPIs, and that's the reason why PCABs have become so popular. They improved the acid control. But you can see the same giant leap between the first-generation PCAB to our drug, linaprazan glurate in number of hours improvement. And this is the reason why -- to believe why you can do this again. I mean this is the reason to believe how to differentiate and position the product. So we actually have now have a solution of the product here and the solution of the disease and how to help the patients with severe erosive GERD. But if you also look into this clinically and not only from acid control perspective, we can actually plot in the data into this diagram or biomarker diagram that we show -- that I showed you earlier. Now we have also all the data, all the healing data from both vonoprazan and now also from tegoprazan, the second PCAB in U.S. And what you can see here is they have compared their drug also to the PPI, lansoprazole. What you can see here is that it's perfectly spot on to the linear correlation here. With lansoprazole on 63% pH control, the data shows healing rate of the C and D in 8 weeks of 60% to around 70% (sic) [ 68% to 72% ]. Tegoprazan just last week presented their healing data with 75% acid control, they delivered approximately 80% healing data on C and D patients. And previously, we already know about vonoprazan acid control between 65% to 85% and with a healing rate of approximately 90%. As we already have communicated and what we have seen in our data is that we have acid control of 96%. So it will be very interesting to follow now the top line results from our first pivotal Phase III trial coming up later this year. So it looks indeed very promising here. So if I just go to summarize the differentiation factor now that we become more and more obvious how to promote this product as best-in-class, where you can see the acid control of the linaprazan glurate compared in the middle there with 96% in comparison to PPI 40% to 70% and first-generation PCABs vonoprazan 63% to 85% and tegoprazan now in 75%. We have a very fast onset. We reached full effect and -- already after the first dose in an hour. And that is, of course, important for many of the different perspectives. The good acid control gives us a very good effect. We have in our Phase II data in the best cohort there delivered 93% -- 55% units better healing effect in the severe patient in 4 weeks compared to the lansoprazole. So 55% units in -- different in delta. And that should be in comparison what we now see with vonoprazan and tegoprazan, the products that now have ambitions then for U.S., where they have a delta effect, delta approximately of 15% to 20% on 2 to 8 weeks. So this is a huge difference, as you can see. We have more than the double delta compared to what they have. Our ambition is to heal patients in half the time, 4 weeks instead of 8 weeks, which is the standard of this treatment, thanks to this fast and great acid control. And of course, we are looking into the symptom relief and delivering superiority there as well, especially focusing on the nighttime symptom, which is something that every second patient is complaining about, especially pain during nighttime. So this is how we're going to differentiate the product. Also, I just wanted to mention things about the financing -- structured financing we finalized during the quarter. So in March, we entered into a long-term structured credit agreement with Claret Capital Partners, Europe's largest independent growth debt fund manager. The total amount is up to EUR 28 million. The financing is divided into 4 tranches. Structure a secured loan facility with warrants and convertibles and is aligned with key clinical and operational milestones in our program. We draw down an initial EUR 8 million tranche, and that's tranche A at signing already in March. This new capital allows us to look beyond the HEEALING 1 readout. And I mean, to begin the preparatory work for the next pivotal HEEALING 2 trial in parallel rather than do it sequentially. So we can -- I mean, the intention is that we can move efficiently toward our final Phase III milestone while minimizing the dilution of existing shareholders. It does also contribute to financing the remaining development and prelaunch activity of linaprazan glurate. So this is an important deal that we have done, and it will be very supportive for the future. So just key summaries of the key events. In February, we received positive feedback from the EMA on the CMC, the Chemistry, Manufacturing and Controls strategy for linaprazan glurate. EMA confirmed that our planned CMC approach is well aligned with the requirement from -- for the upcoming marketing authorization application. We got similar positive FDA feedback from U.S. last autumn, and we now have consistent alignment from both agency in Europe and U.S. on our CMC strategy. This is really important. Also, FDA provided a positive assessment of our nonclinical development plan following a scientific advice meeting. They concluded that based on the current data package, no additional toxicology studies are required ahead of the future NDA submission. This reduces the development risk and contributes to a more time and resource efficient path to the filing. In February, as you also know now, FDA clarified in a publication in The New England Journal of Medicine that a single adequate well-controlled pivotal study complemented by supported evidence will become the new standard for drug approval in the U.S., including for common diseases. And that's, of course, eGERD, erosive GERD is included in that. This confirms that our current Phase III program is considered as sufficient basis for regulatory submission in the U.S. in addition to the European ones. And as I also just mentioned, we signed a EUR 28 million financing agreement with Claret Capital and where -- which EUR 8 million is already drawn in March. Also, I just mentioned, our licensee, Sinorda and the local partner, HuaDong has during the quarter launched linaprazan glurate on the Chinese market, which, of course, is an important milestone for us. So to conclude, we have continued to take important steps and have strengthened our position in this past quarter. So with that, I will pass it to Margit for Phase III HEEALING 1 study update. Margit, so please go ahead.

Thank you so much. I will give a brief update on enrollment of subjects in our Phase III ongoing study, HEEALING 1. And in general, patient inclusion have followed our projections throughout the trial. You can see the development of screened patients on the right side of the slide. And at this point in time, we have about 20% -- about 85% of study patients screened and more than 2/3 of study participants have been randomized to the treatment. And provided that we have had this stable screen enrollment pace, we can also feel confident to say that the last patient will be screened within the coming months. The top line results are expected to be available during the last quarter of this year as has been communicated before. So in a short recap of the study, we will include or randomize about patients in about 100 clinical sites across 8 European countries. So treatment time is 8 weeks and the primary endpoint is superiority to our comparator in healing of patients of severe eGERD, which means LA grade C/D patients at 4 weeks of treatment. And we have several key secondary endpoints, including healing and symptom relief both at 4 and 8 weeks of treatment, both in C/D patients and in all patients. All patients are referring to the LA grade A patients. And after the top line results from HEEALING 1 available, we will then initiate second healing study, including also maintenance study, which will also involve patients in U.S. So that was a short summary of HEEALING 1.

Okay. Let's go to the financials then. But thank you very much, Margit. It looks very promising, and everything goes according to plan when it comes to this important pivotal Phase III trial for us. So that's very good. Thank you. So Magnus, go -- please go ahead with financials. Sorry.

Thank you, Christer. Yes. Here, you can see Q1 2026 financial highlights. And if we look at the cash balance, we ended the quarter with a cash balance of SEK 476 million compared with SEK 487 million at the end of 2025, giving us a continued flexibility as we advance the HEEALING 1 study and prepare for the HEEALING 2 study. Total cash flow for the quarter was minus SEK 12.7 million compared with minus SEK 42 million in the same period last year. And during the quarter, as Christer mentioned, we received the first drawdown under the Claret financing agreement, approximately SEK 86 million before transaction costs, which supported the quarter's overall cash flow. R&D remained a clear driver of our cost base at 91% of operating expenses and R&D expenses were SEK 91 million in the quarter compared with SEK 38 million last year and is mainly reflecting the ongoing Phase III study as patients are recruited and screened as Margit just mentioned. Operating loss for the quarter was SEK 90 million -- almost SEK 91 million compared with SEK 47 million in Q1 last year, and the increase reflects the higher activity level in the Phase III program. At the end of the quarter, we had 22 FTEs and in total, 17 employees and 27 consultants were affiliated with the company at the period end. Overall, our first quarter reflects the focused investment in the Phase III execution together with the added financial flexibility from the Claret facility. And if we move to Slide 12, here, you can see the financial overview year-to-year. And if we look at the net sales, they amounted to SEK 10 million compared with SEK 0 million last year, and the revenue consisted partly of the license income from the Zentiva partnership in Europe and partly of revenue from Sinorda in China. Operating expenses increased year-to-year to around SEK 100 million and is driven primarily by the higher R&D spending as the Phase III program moved into active execution phase. Administrative expenses also increased modestly, mainly due to consultancy fees and higher rental costs following the move to new premises as we mentioned before. Net loss for the quarter was around SEK 88.8 million compared with SEK 33.7 million last year. And if we finally look at the balance sheet, as I mentioned, we have cash at the end of the period was SEK 476 million. Equity at the end of the period was SEK 281 million compared with SEK 369 million at the end of 2025. Liabilities for the quarter reflected both the ongoing prioritization of the Zentiva upfront payment and the first tranche on the Claret financing facility. Current liabilities increased mainly due to interest-bearing liabilities of almost SEK 46 million and convertibles and warrants of SEK 33 million arising from debt financing. And overall, our financial position remains aligned with our Phase III execution plan. And after the first Claret drawdown, we estimate the current working capital is sufficient into the third quarter of 2027 according to our current plan and assumptions. And with that, I will hand back over to Christer.

Okay. Thank you, Magnus. Thank you. So I mean, this brings us to the end of our formal remarks. Before we open for the line for questions, a few important dates ahead. Our Annual General Meeting will be held in May 21. We will report the second quarter in August 19 and the third quarter in the 11th of November. And of course, we will keep you updated on our Phase III study, expected top line in the fourth quarter. Exciting times. So a potential key value inflection point in the end of -- in the last quarter of this year. So with that, I would like to open for the line for questions. So operator, please go ahead.

[Operator Instructions] The next question comes from Georg Tigalonov-Bjerke from ABG Sundal Collier.

This is Georg from ABG calling. I have 2, please. Firstly, are you able to provide some guidance on how OpEx is expected to develop over the remainder of the year, perhaps using Q1 as a reference point? Secondly, I'm curious whether you could say a few words about the recent somewhat unusual block sale of shares conducted by one of your former Board members.

Okay. Thank you, Georg, for your questions. I mean, normally, we do not guide in the future-looking costs. But what we have said is, of course, that we have cash now with current activities into Q3 '27. And as you know, the -- most of the cash is going to the Phase III trial, which is ongoing now for full speed. And that, of course, is costly. And -- but that, of course, in the end of the period, we will -- I mean, the cost level will go down, but it will be kind of cost intensive the next quarters as well. But as I said, I mean, our estimate is that we have cash -- good cash position into Q3 '27. The next question you had was regarding one of the major shareholders or one of the old founders. He is 75 years old and retired from the Board in December and -- last year and has no -- as such, no involvement in or visibility into the company's operations anymore. We were also surprised by the transaction and how it was handled, but he has not given any formal statement related to the sale, but the company has no reason to believe that he has another motive and the diversify -- diversify of his personal financial exposures. So -- and there is nothing new in the company. And as you have seen, the Phase III trial looks very promising and everything goes in the right direction as we wanted for the company. So it was, I mean, a big surprise also for us, unfortunately. Any other questions?

The next question comes from Arvid Necander from DNB Carnegie.

So the first one on enrollment with about 85% of patients screened, but only about 2/3 randomized. Is this an expected timing lag between screening and randomization? Or does it represent a higher-than-expected screening failure rate? And if so, should we read anything into this in terms of time lines or the final study population? And then secondly, on the tegoprazan data at DDW, now that we have the final or the full data set, how do you expect this to influence competitive dynamics across the PCAB drug class? Those are my questions.

Okay. Good. Thank you, Arvid, for that question -- these questions. Firstly, I can say that this -- I mean, screen failure rate is according to plan, approximately 50%. So that is just what we have expected. And there is, of course, the screening period is, I mean, more than 4 weeks. So that's also a delay in that, not a delay, but that's how the procedure works. When it comes to -- always when it comes to studies like this, I mean, this is a big study. It's a little bit slow in the beginning and the last month, the pace is increasing significantly if you have done your work as you should. So the pace now is -- with screening is on all-time levels. So that is the reason I would say that we are screening very high -- with very high pace in all the -- in most of the sites just now. And therefore, since we have more -- I mean, since there are 4 weeks between screened and randomized, so that is the outcome of that. So nothing to -- I mean, nothing to worry about is exactly according to what we have seen and what we have planned. And that's actually, I would say, very good. I mean we are following our plans. And that is, of course, that's something that pleased me well. I mean this is very good performance from my team here. So -- and then when it comes to the other question regarding tegoprazan, as you might have seen then, they published and reported -- announced their results last week during the DDW in Chicago. And we were there, of course, and learned a lot. And what you could see is this is perfectly in line to what we could estimate before. We saw the results with their acid control a little bit lower than vonoprazan. We should not expect any other results than we now see with a little bit more than 80% of the C and D patients in 8 weeks, which is totally in line with what I showed you before according to the biomarker and the correlation between acid control and healing. And also, it seems also that they have a little bit faster onset compared to the vonoprazan. So that's also what we have seen before in the acid control curves from them. And yes, so it's nothing to -- it's perfectly in according to our plan, how to differentiate ourselves versus the first-generation PCABs. We have, with 96% acid control, great chance now to deliver best-in-class results of both acid control, but also in healing and in symptom relief. And that is what we will see now, hopefully then in the Phase III trial coming up in the end of the year. And when we listen and discuss this with our key opinion leaders and the market, there is a good chance that we can deliver that. And of course, that will be seen as a clinical, I mean, relevant differentiation and position for our product. And that is very promising then for the future. And we -- and looking into also regarding the market dynamics now with 2 PCABs, not yet. Tegoprazan will come -- will launch most likely next year in 2027. But I think that's good for the class and for the market because then there are 2 players talking about PCABs instead of 1 player talking about vonoprazan. So now we're going to start to discuss the class instead of the unique substances. And that's good for us. It's good preparation for us coming out as best-in-class drug and gives us good opportunity also to target high PCAB users as well in U.S. And that's, of course, good for us coming in as #3 in the U.S. But also, it's good also to see that we definitely still have the chance to be first in Europe with the best-in-class potential here as well. So that's -- yes, I mean, I think this just supports what we have said before. Okay. Anything else? Any other questions?

[Operator Instructions] The next question comes from Joseph Hedden from Rx Securities.

So with the financing agreement with Claret in place and the ability to streamline and speed up the start of your second Phase III trial, assuming positive results from HEEALING 1, what kind of time lines could you be looking at for the second pivotal study in terms of start the study and potential time line to results?

I mean we are -- I mean, if we now look at what we have said that we can start preparing the HEEALING 2 now and do that in parallel. And the more you can do that, normally, it's from the timing of the signing of the healing -- of the study before you're having first patient in into the trial is normally 6 to 8 months or something like that. And of course, that period is not for free. And the more we get there, the sooner we can start. But in any case, our intention is to start this in next year. And the sooner -- and the more we can work on it now, the sooner we can initiate it. And of course, we are also a little bit dependent on the results of the HEEALING 1 study as well. So we cannot -- we would like to see that and have the full report from that before starting up everything. So it's not -- I mean, so we can actually gain from that kind of information when we finalize the HEEALING 2 study. Was that an answer on your question or...

Yes, sure.

But also, yes, we will come back more on the timings on the HEEALING 2 later directly either before or after the readout of the phase -- of the HEEALING 1. So you will learn much more about that in the next coming months and year. So...

There are no more phone questions at this time. So I hand the conference back to the speakers for any written questions or closing comments.

Okay. I'm also looking if we have any written questions here. Yes, there are some questions regarding the sales from one of the founder, but I think I have already responded to that. And then also regarding the Claret deal, well, I mean, what we have said is that -- I mean, the Claret deal, I mean, what we can see on the tranches there is that we have 4 different tranches when it comes to Claret. And that's -- I mean, the intention with that is that the tranches should be used when we have had value inflection points according to our development steps. And the Tranche B and C are in total EUR 8 million. And the Tranche C is conditioned upon positive top line data from HEEALING 1. And Tranche B could, of course, with that saying, could be -- yes, I mean, so -- and also the second -- the last tranche, Tranche B is also dependent on condition upon positive top line results of the HEEALING 2. So definitely very much supporting and aligned with the development steps. And yes, and the difference between B and C is that the Tranche B is a convertible loan and the Tranche C is a term loan. So that's the difference. Okay. I think we stop there if there are no other questions. And I wish you a great day, and I hope to stay in touch and come back with more information regarding the HEEALING 1 study in relatively near future then. So thank you very much for your interest in Cinclus Pharma, and have a nice day. Thank you.