Thank you very much, and hello and welcome to Cinclus Pharma's fourth quarter and full year 2025 earnings call. As you already heard, I'm Christer Ahlberg, I'm the CEO of Cinclus Pharma, and with me here today, I have our R&D Director Margit Mahlapuu and our Interim CFO Patrik Nordgren.

We will present the latest developments from the Q4 2025 and the upcoming news flow, after which we will be happy to answer any question you might have. Let's go to the first, and as we are a public company, be aware of the disclaimer.

I will not read it through for you, but nevertheless, it's good to have there so you're aware of that. Going to the first slide then, just a summary of Cinclus Pharma and our lead candidate, linaprazan glurate.

This substance represents the new class, P-CABs, within the gastric acid-related diseases. This belongs to the next generation of the P-CABs and have a unique possibility to deliver 24-hour acid control.

That's the first of all P-CABs to actually have a chance to do that, with 96% acid control over the 24 hours. With that, we also can address the high unmet medical need still exists within this area, in this class, among especially the severe erosive GERD patients.

They require and they need full acid control, actually, to be healed and to get symptom control. Within this target population, we are targeting approximately 10 million patients in US and in Europe, and globally, the same number, approximately 19 to 20 million patients.

It's a huge blockbuster potential also in this target population, and in this specialty pharma position of this product. We have delivered a very good Phase II data, good healing data, and now we are going to repeat this data and the outcome of the Phase II.

The ambition is that to show superiority in the first Phase III trial called Heal 1. We expect to have the results of that in the end of this year.

Beyond our core market, P-CABs are also gaining global momentum. That's clear.

We can see now that they are launched and available in more than 30 countries across the world, and actually the growth is growing quite significantly, and they are taking over after PPIs, I would say, in the markets where they have been launched. They are now also incorporated in many guidelines, and definitely we can see that this is further validating the mechanism of action and the safety and efficacy, and also the commercial opportunity for linaprazan glurate going forward.

If we look into the different territories, if you go to US first, where we have a launch of vonoprazan by Phathom, 2025 was the first full year of launch, and they recently announced the revenue of approximately $175 million over 2025, with more than 1 million prescriptions filled during the year. That's very encouraging, and also it will be interesting to follow this forward, and they have also guided that they will reach profitability in the second part of 2026.

We also see in US that the second P-CAB, the first generation P-CAB, is on his way. We have a submission early this year, or where tegoprazan most likely will be launched by Sebela in 2027.

Going then further to the other markets across Asia, we can see that in Japan, we have already seen that Takeda launched vonoprazan some years ago, 2015, and they have now 44% market share in value of all the reflux treatments available in Japan. In Korea, the same market share is approximately 23% and with a high growth rate, double-digit year-on-year growth.

In China, plenty of P-CABs now are approved and are launched. Our substance, linaprazan glurate, is also approved and will be launched during the 20 during this year, after we have received price and reimbursement approval from 1st of January in 2026.

Beyond Asia, we can see also in South America P-CABs taking market shares. In Mexico, for instance, the first P-CAB reached number three in the market position within two years, with a also very good pricing outpricing the PPIs.

Taking these together, these trends underscore a clear global shift towards P-CABs and reinforce the significant commercial opportunity for the next-generation agent such as linaprazan glurate. Also, a little bit about the treatment and the differentiation with our substance compared to the other P-CABs.

We have been discussing this many times before. Importance of the biomarker, which is very much established within this area, where you can see a linear correlation between the percent of reaching pH above 4 in this acidic content in the stomach.

If you can reach that close to 100%, the longer you can reach that during the 24 hours, the more patients and you can heal. That correlation is totally linear, as you can see.

As we have delivered 96% acid control, we definitely will come very close to 100% in healing. You can also put these kind of figures into this curve and you will see the correlation thoroughly and robust versus the healing rates every PPIs and P-CABs has deliver in the past.

With that said, I think it's interesting to look into the comparison here and the evolution of the different drugs over the years. On the top row there, you can see the acid control, 24-hour acid control over pH 4, which is the biomarker, an important to reach to have a chance to heal patients, especially the severe patients.

From the left side, you see the evolution, 33% acid control of the H2, 40% to 70% for the PPIs, and then 70% to 85% for the first generation P-CABs, including tegoprazan and vonoprazan, and then our substance, linaprazan glurate, with 96%. If you flip the coin then and look into how many hours actually that means for patients having pH below 4 during the 24 hours, that the acidic content has a chance actually to fry the mucosa in the esophagus and also stop potential healings.

With H2 blockers, you can see 16 hours below pH 4, which is the majority of the time of the 24 hour. That's the reason why PPI became the most sold drugs in the world later on when they were introduced to the market, because you see the giant leap, the development in the incremental benefit here.

You improve the acid control to 7 to 13 hours below pH 4 instead of 16 hours. Now you can see that's another reason and history repeat itself again.

You see that 4 to 7 hours P-CABs, first generation P-CAB, deliver, and that's of course an improvement compared to the PPIs, as you can see. This is reason to believe why they actually have succeeded so well in the markets where they have been launched.

You can see now, we have reached how to solve this acidic issues. We are now down to more or less a complete acid control and only one hour left below pH 4, which is unique, no one is close to that.

You can see the incremental benefit that we deliver compared to the first-generation P-CABs is actually similar compared to what they delivered versus PPIs, and also similar difference compared to what PPIs delivered to H2 blockers. This is definitely a chance to actually deliver this again.

This is, in a nutshell, the differentiation we are looking to versus the first-generation P-CABs in the future. Also wanted to give you a little bit of updates on our partnerships.

As we delivered during 2025 a very good partnership deal together with Zentiva, which definitely validate the substance. This is the first partnership deal in Europe and we have the chance to become the first in Europe.

This is interesting to see, because of course Zentiva could have gone with any other P-CABs, but they choose to go with our because we, as you saw now, deliver the best chances actually to differentiate versus PPIs and have the best chances to deliver a very good price in Europe. With that said, we have now ongoing work together with them, both in price and reimbursement development, but also when it comes to manufacturing and preparation of the commercialization.

The start of this partnership looks very promising, and works very good. As I also mentioned, we have the partner in China, Sinorda.

They have now an approval of the price and reimbursement, and they, together with Huadong, preparing the launch for 2026. Let's go in then to the quarter and what we have delivered during the quarter.

During the fourth quarter, we dosed the first patient in our first Phase III trial, Heal 1. That is designed to confirm the efficacy of linaprazan glurate in patients with erosive GERD.

This is definitely a really big and important key milestones for us as well as for the program. We also presented positive data during the UEGW in Berlin from optimized commercialization-ready tablet formulation.

That's selected for both Phase III, but also for the future commercial product as well. In addition to this, we have also received positive feedback from FDA and alignment on our proposed CMC strategy following on a meeting in October.

That further supporting our NDA preparation plans there. Beyond clinical and regulatory progress, we strengthen our commercial position through the presentation of our sponsored abstract at ISPOR Europe, highlighting the clinical and economic burden of PPI treatment failures.

We also hosted a virtual event in December focused on real-world clinical practice in erosive GERD, which was very popular as well. We also announced key corporate developments, including the recruitment of Magnus Kristensson as CFO.

Also, as I mentioned now, the granting of China's National Reimbursement Listing for linaprazan glurate, supporting broad access ahead of an expected 2026 launch. Going to what happens after the period, in January, we received a positive assessment from the FDA regarding our nonclinical development plan for linaprazan glurate.

Importantly, the agency confirmed that no additional tox studies are required ahead of the future NDA submission, reinforcing the robustness of our development package. We also received positive feedback from EMA, European Medicines Agency, on our planned chemistry, manufacturing, and control strategy, the CMC strategy.

EMA confirmed alignment with requirement for the upcoming Marketing Authorization Application, further strengthening our regulatory readiness in both Europe as well as in US. With that, I will pass over this now to Margit to present more updates on the Heal 1 study, the Phase III study ongoing.

Thank you. I will provide update on Heal 1, which is our main operational focus at this point in time.

First patient in Heal 1 was dosed in October 2025, and we aim to recruit about 500 patients in up to 100 clinical sites in eight European countries. The treatment period is 8 weeks, and our primary endpoint is superiority compared to comparator in healing of patients with severe erosive GERD, which means an LA grade C/D subjects, at 4 weeks of treatment.

Secondary endpoints is healing and symptom relief both at 4 and 8 weeks of treatment, which is recorded both in C/D patients, but also in all patients, which means an LA grade A-D patients. Patient recruitment is proceeding according to the plan.

On the right side of the slide, you see the recruitment diagram where the actual recruitment is shown in yellow and recruitment projection is shown in green. As you see, we are currently a little bit above the projection line.

In total, we have randomized about one-third of the total study participants. Topline results are anticipated the second half of this year, and after the topline results are available, we are planning for the second healing study and also for the maintenance study.

This will proceed both in Europe and in US. Thank you.

Okay. Thank you, Margit.

Let's go in then to Patrik Nordgren to present the financials. Patrik, please go ahead.

Yeah. Thanks.

Turning to our fourth quarter results, we ended the quarter with a cash position of 487 million SEK, providing continued financial flexibility as we advance the Phase III Heal 1 study. Cash flow for the quarter was -53 million SEK, reflecting ongoing investments in the Phase III program.

R&D expenses amounted to 61 million SEK in Q4 as the study is now fully underway. R&D represented 80% of total operating expenses, compared to an average of approximately 82% over the past eight quarters, clearly demonstrating that the majority of our spend continues to be directed toward clinical development.

Operating loss for the quarter was 62 million SEK, consistent with the expected increase in activity following the initiation of Phase III. We also saw a continued increase in the number of coworkers, now totaling 45, primarily driven by additional consultants supporting clinical and regulatory execution.

Overall, our cost base reflects disciplined investment in our pivotal program while maintaining strong financial control. Now go to the year-over-year.

Looking at the year-over-year comparison for Q4, net sales totaled 13.6 million SEK, compared to 4.6 million SEK in Q4 last year. Revenues primarily reflected licensing income from Zentiva's partnership for Europe, as well as contributions from Sinorda in China.

As previously communicated, the €13 million upfront payment from Zentiva is being periodized over the Phase III program. Operating expenses increased year-over-year, mainly driven by higher R&D spending as patient enrollment and trial execution progressed during the quarter.

EBIT for Q4 was -62 million SEK, compared to -56.9 million SEK in same period last year, reflecting the higher Phase III activity level. Financial net was 0.9 million SEK, primarily related to interest income on cash balances.

Net loss for the quarter was 61.2 million SEK, compared to -54.3 million SEK last year, also, again, reflecting increased clinical investment. On the balance sheet, cash at the year end was 487 million SEK, compared to 566.7 million SEK at the end of 2024, which reflecting planned Phase III expenditures.

Non-current assets increased to 9.7 million SEK, mainly due to leasing of new office premises. Other current assets increased to 49.6 million SEK, primarily driven by CRO prepayments in line with the clinical program.

Non-current liabilities rose to 40.4 million SEK, largely reflecting the long-term portion of the Zentiva contract liability. Current liabilities increased to 136.8 million SEK, primarily representing the short-term portion of the same deferred revenue.

Overall, our financial position remains solid and well-aligned with our Phase III execution plan. Now over to the shareholder slide.

This slide presents our shareholder structure as of December 31, 2025. The 15 largest shareholders together hold approximately 55.3% of total shares, reflecting a stable and long-term oriented ownership base.

Our IPO cornerstone investors together account for approximately 24.6% of total shares, and our founders collectively hold approximately 16.4%, maintaining strong alignment with shareholders. In total, cornerstone investors and founders together represent 40% ownership, providing strategic continuity and long-term commitment as we advance linaprazan glurate through Phase III and toward commercialization.

Okay. Thank you, Patrik.

This actually concludes the formal presentation, and before opening the line for questions, I would like to highlight few important upcoming dates at least. As you see there, we have the annual report in April, and also the report for the Q1, and followed also by the AGM in May.

With that, I think I would like to open the line for questions, and I suppose you will have a description on that now.

good morning, and thanks for taking my questions. The first one on the Heal 1 timeline, can you provide a little bit more detail on the expected trial progression from here and the milestones we should be tracking towards to support the H2 topline targets?

I guess mainly when do you expect to have all the patients randomized? Second one on pricing and tegoprazan.

I guess based on available data for tegoprazan, it seems like price would be the main lever for differentiation. How do you expect the P-CAB pricing dynamics to evolve following the launch of tegoprazan?

Thank you.

Let's start with the first question. Of course, we will continuously report the progress of the Heal 1 study.

As we now saw, we have one-third randomized. As you see and as the pace will speed up during the period of initiation of different sites, it's a step-by-step approach.

It will be massive recruitment in Q2 and close to summer. We then, of course, after the patients are dosed and randomized, they will be part of the study at least for 8 weeks and then with some weeks follow-up, safety follow-up.

That means that after the last dosed patient, before we can close the study, we need to have 12 weeks in treatment, so that's three months. As we have seen here, the primary endpoints, of course, the outcome of that will be reported as well as a number of other secondary endpoints.

We are as we speak discussing the different endpoints that we're going to report during the topline. It's a little bit too early to announce that yet.

We will come with that later on. Then, of course, after the topline results is presented, we will also have a publication in the next coming congress, DDW in US, that is in May 2027.

Then on top of that, we will add, of course, other data into the European Congress, UEGW, in the fall 2027 and combined with a full publication of the trial as well. It will be delivered step-by-step the information.

I think this is what I can say now and what I can give you for the time being. When it comes to the second question, can you repeat that again, Arvid?

I guess essentially how do you think the P-CAB pricing dynamics will evolve once tegoprazan is launched?

That is of course is a important questions. If you look at the data, they have not reported the data.

They have only reported the superiority and non-inferiority data. When it comes to healing, it's looked like that they are better than PPI, and nothing else should be expected.

When it comes to symptom relief, they're only comparing themselves versus placebo. That's a little bit complex to see whether they are better or not in symptom relief versus PPIs.

With that said, I think they will be very much of close in data compared to vonoprazan. Of course, it will be competition both in data, of course, but also in pricing in US in one or another way.

With that said, this is something that we have seen all the time that all the first-generation P-CABs are very similar and they are delivering more or less non-inferior data versus PPIs and among themselves. That's because, as acid control of tegoprazan is less compared to vonoprazan.

This is no surprise that the data is not very big difference, and actually maybe might be lower healing compared to vonoprazan. That's the reason why we have put so much of effort into our development and actually to deliver a product that actually can meet, firstly, the unmet medical need for the severe patients and then also being competitive versus the first generation, because from the history we know that acid control matter.

If you have a product that definitely deliver better acid control, that's a reason to believe that you also can help the most severe patients. That is of course something that we will negotiate with the pricing authorities and the pricing insurance company in US.

We do not expect that we will have any other step-through compared to the first generation of P-CABs, it will be most likely step-through via PPI to P-CABs, but not within the P-CABs group. Then is of course a matter of negotiation with the different insurance company what layer you will be actually recommended to.

That's the first. In Europe, of course, here we don't know whether we will be first or not, but the importance for us is to put as much distance between our product compared to the PPIs, you actually have the chance to get a good premium price also in Europe.

In US, of course, it will be a discussion on, but actually we believe if we have better data, our ambition is to put it in parity with the first generation of P-CABs, but of course, if the data is really good, as we expect, then why should we not ask for a premium compared to that? That is definitely a possibility as well.

Was that answer all questions,

Arvid? Absolutely.

I'll jump back in the queue. Thank you.

Okay. Other questions?

Good morning. Thanks for taking my questions.

Just on the potential second study that you will have coming up, as that's got a maintenance element, I was just wondering on what kind of duration you were expecting that to take. Then secondly, with the launch in China potentially happening later this year, I wondered if you could refresh our memories on the terms of the deal with Sinorda.

Thank you.

Thank you for the questions. Regarding the second healing study that will study the same type of patients when it comes to healing as we have done now in the Heal 1, but it will also study maintenance of the patients.

What you have seen in the maintenance study, both for Sebela and for Phathom, and what is standard these days is that you need to have a maintenance of 24 weeks measured. A little bit, yeah, you can say six months then.

That is what we will be evaluated and also submitted to the authorities. On top of that, we also, of course, will follow up with long-term safety follow-up, and for 100 patients needs at least be delivered 52 weeks of safety follow-up.

That is what we need to deliver, but we submit the application with 6 months data. That was the first question.

Second question was regarding China. What we can say there is that now, they are preparing the launch.

Sinorda signed a deal with Huadong in the end of last year, now they are together aligned preparing the launch. We have an agreement with Sinorda since many years, since 2015, where they actually have developed their formulation and clinical development program in China, and we have developed and prepared our formulation and development program for the Western world.

When it comes to the terms together with Sinorda, we have low double-digit figures that we will get on all the milestone payments, including both regulatory down payments as well as the sales milestones payments. We also have a royalty in China which is on very low level of one-digit royalty income for us on the net sales that actually Huadong are selling for.

That is what we have communicated before, and that's still a reminder on what we have there. In other markets like Japan and South Korea, for instance, which also is covered by Sinorda, we have a totally different setup where we have a profit share split between the companies.

Other questions?

Actually, we have some written questions. Here is a question from one person: "What are your views of Sebela Pharmaceuticals NDA submissions for the tegoprazan, and how does an eventual approval affect the future market dynamics for linaprazan glurate?"

Thank you for the question. That's an interesting question.

Most likely, they will be approved and launched in 2027. This is not a big problem for us, I think.

We need to remember. Firstly, actually, they have less acid control compared to vonoprazan, it's a little bit like a me-too product to vonoprazan, belongs to the first generation here as well.

We know also this market is so big. There are so many patients.

They have focusing quite a lot on the symptomatic patients, but also of course on erosive GERD. It seems like tegoprazan might have a faster onset compared to vonoprazan, so that might be a position that they will grab, and that of course very good for symptomatic patients.

There will be definitely a room for different positions in this market. When we had PPIs launched, we were six different PPIs in the market and all of them became blockbusters.

I also need to remind you there, the price level of PPIs were approximately in US 1 1 1 25% compared to what you have on the prices you have currently, and despite that, they became blockbusters. We need to remember, number of patients are so many.

We're talking about the most severe patients, we only in US have 4 million patients. If you add then 40% of patients still suffering from pain in US, we're talking about 40% of 60 more than 60 million.

It's so many patients suffering from this in US, the number of patients is enough for more than one player. We expect that in US we will be a handful of different P-CABs in the end, and this is according directly to our plan.

There is another question also: "How much of the upfront near-term milestones from Zentiva deal is yet to be received?" We have received the upfront.

That is received. We're still waiting for the near-term milestones, which will be part of the read-out of the Phase III trial, the first Heal 1 study.

When we have the report there, then the intention is to come with as a near-term milestone. I think that's it.

I think that was the question we have, if no one else want to add anything more. Then I think I stop there.

Thank you for your interest in Cinclus Pharma, and let's stay in touch. Have a nice day.

Thank you and bye.