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, CEO of Cinclus Pharma.

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. Let's go in then directly to the presentation.

As you know this, our lead asset, linaprazan glurate, is the next-generation P-CAB built around one defining property: sustained, round-the-clock acid control that differentiates this substance from both PPIs and from the rest of the P-CABs, especially in severe erosive GERD, which is our target population. The patient population we are addressing is large and underserved, roughly approximately 19 million patients worldwide, and 10 million are people or patients from US and Europe.

These patients do have severe erosive GERD, and a substantial share of them are not adequately healed on today's standard of care, including P-CABs. 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 3 program, based on the strong Phase 2 results we generated previously, began in last year in October.

Our first study, Healing 1, has had a very good progress, and we will learn more about that later in this presentation. We actually are approaching full enrollment in this Healing 1 study, and we have now good visibility on the timelines with expected topline 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 have a very well-defined CMC plan, also aligned with authorities. P-CABs are gaining really global momentum, now available in more than 30 countries and increasingly incorporated into treatment guidelines, which is important, 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 Sentiva in Europe worth up to €220 million. This cooperation works well very well.

We also have a license agreement with Sinorda for selected markets in Asia. In fact, as we already have communicated, linaprazan glurate is now launched in China by Sinorda's partner during the Q1.

Sinorda's partner is Huadong. Now we have ongoing local reimbursement application, but in the end of last year, we actually received the national reimbursement in China, so that's very positive.

This makes a simple, but important point. How well a drug controls gastric acid over 24-hour day predicts how well 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 P-CABs.

The biomarker is there, and the correlation is there for all of this drugs. This is a central scientific argument for our program.

Our acid control is the biomarker that drives healing in this disease. The more of the day you can keep the gastric pH above 4, the greater the chances you have to heal the patients.

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 the market for decades here, where you started with the H2 blockers. On the top row, you can see the acid control in percentage over the 24 hours, meaning pH above 4.

In the diagram there, you can see the number of hours where you are below pH 4. Below pH 4, there is a risk, each hour you are below, there is a risk that you actually get erosions and symptoms based on the acidic 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 have another giant leap going into the first generation of P-CABs from PPIs, and that's the reason why P-CABs have become so popular. They improve the acid control.

You can see the same giant leap between the first-generation P-CAB to our drug, linaprazan glurate, in number of hours improvement. This is the reason why to believe why you can do this again.

This is the reason to believe how to differentiate and position the product. We actually have now a solution of the product here and a solution of the disease and how to help the patient with severe erosive GERD.

If you also look into this clinically, not only from acid control perspective, we can actually plot in the data into this diagram, a biomarker diagram 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 P-CAB in US.

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 rates of the C and D in eight weeks of 60 to 60 around 70%. Tegoprazan, just last week presented their healing data with 75% acid control.

They delivered approximately 80% healing data on C and D patients. Previously we already know about vonoprazan acid control between 65% to 85% and with an 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%. It will be very interesting to follow now the topline results from our first pivotal Phase 3 trial coming up later this year.

It looks indeed very promising here. If I just going to summarize the differentiation factor now that will 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 P-CABs, vonoprazan 63% to 85% and tegoprazan now in 75%.

We have a very fast onset that we reach full effect and already after the first dose in an hour. That is of course important for many different perspectives.

The good acid control gives us a very good effect. We have in our Phase 2 data in the best cohort there delivered 55% units better healing effect in the severe patients in four weeks compared to the lansoprazole.

So 55% units in delta. That should be in comparison what we now see with vonoprazan and tegoprazan, the products that now have ambitions then for US, where they have a delta approximately of 15% to 20% on two to eight weeks.

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, four weeks instead of eight weeks, which is the standard of this treatment thanks to fast and great acid control. Of course we are looking into the symptom relief and delivering superiority there as well, especially focusing on the nighttime symptoms, which is something that every second patient is complaining about, especially pain during nighttime.

This is how we're going to differentiate the product. Also, I just wanted to mention things about the structured financing we finalized during the quarter.

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 €28 million.

The financing is divided into four tranches, structured as secured loan facility with warrants and convertibles, and is aligned with key clinical and operational milestones in our program. We draw down an initial €8 million tranche, and that's Tranche A at signing already in March.

This new capital allows us to look beyond the Healing 1 readout and to begin the preparatory work for the next pivotal Healing 2 trial in parallel rather than do it sequentially. The intention is that we can move efficiently toward our final Phase 3 milestone while minimizing the dilution of existing shareholders.

It has also contributed to financing the remaining development and pre-launch activity of linaprazan glurate. This is an important deal that we have done and it will be very supportive for the future.

Just summaries of the key events. In February, we received positive feedback from the EMA on the CMC, the chemistry, manufacturing, and control strategy for linaprazan glurate.

EMA confirmed that our planned CMC approach is well aligned with the requirements for the upcoming marketing authorization application. We got similar positive FDA feedback from US last autumn, and we now have consistent alignment from both agencies in Europe and US on our CMC strategy.

This is really important. Also, FDA provided positive assessment of our non-clinical 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 US, including for common diseases. That's of course eGERD, erosive GERD is included in that.

This confirms that our current Phase 3 program is considered as sufficient basis for regulatory submission in the US in addition to the European ones. As I also just mentioned, we signed €28 million financing agreement with Claret Capital, which of €8 million is already drawn in March.

Also, as I just mentioned, our licensee, Sinorda, and their local partner, Huadong, has during the quarter launched linaprazan glurate on the Chinese market, which of course is an important milestone for us. To conclude, we have continued to take important steps and have strengthened our position in this past quarter.

With that, I will pass it to Margit for Phase 3 Healing 1 study update. Margit, please go ahead.

Thank you so much. I will give a brief update on enrollment of subjects in our Phase 3 ongoing study, Healing 1.

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.

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. Provided that we have had this stable screening enrollment pace, we can also feel confident to say that the last patient will be screened within the coming months, and the topline results are expected to be available during the last quarter of this year, as has been communicated before.

In a short recap of the study, we will include or randomize about [unclear] patients in about 100 clinical sites across eight European countries. Treatment time is eight weeks, and primary endpoint is superiority to our comparator in healing of patients of severe eGERD, which means LA Grade C/D patients, at four weeks of treatment.

We have several key secondary endpoints, including healing and symptom relief, both at four and eight weeks of treatment, both in C/D patients and in all patients. All patients then referring to the LA Grade A to D patients.

After the topline results from Healing 1 are available, we will then initiate second healing study, including also maintenance study, which will also involve patients in US. That was a short summary of Healing 1.

Let's go to the financials then. Thank you very much, Margit.

It looks very promising, and everything goes according to plan when it comes to this important pivotal Phase 3 trial for us. That's very good.

Thank you. Magnus, please go ahead with financials.

Thank you, Christer. Yes.

Here you can see Q1 2026 financial highlights. If we look at the cash balance, we ended the quarter with a cash balance of 476 million compared with 487 at the end of 2025, giving us a continued flexibility as we advance the Healing 1 study and prepare for the Healing 2 study.

Total cash flow for the quarter was -12.7 million compared with -42 in the same period last year. During the quarter, as Christer mentioned, we received the first drawdown under the Claret financing agreement, approximately 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. R&D expenses were 91 million in the quarter compared with 48 million last year, and is mainly reflecting ongoing Phase 3 study as patients are recruited and screened, as Margit just mentioned.

Operating loss for the quarter was 90 almost 91 million compared with 47 million in Q1 last year, and the increase reflects the higher activity level in the Phase 3 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 focused investment in the Phase 3 execution, together with the added financial flexibility from the Claret facility. If we move to slide 12, here you can see the financial overview year-to-year.

If we look at the net sales, and they amounted to 10 million compared with 0 last year. The revenue consisted partly of the licensing income from the Sentiva partnership in Europe and partly of revenue from Sinorda in China.

Operating expenses increased year-to-year to around 100 million and is driven primarily by the higher R&D expending as the Phase 3 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 88.8 million compared with 43.7 last year. If we finally look at the balance sheet, as I mentioned, the cash at the end of period was 476 million.

Equity at the end of period was 281 million compared with 369 at the end of 2025. Liabilities for the quarter reflected both the ongoing periodization of the Sentiva upfront payment and the first tranche under Claret financing facility.

Current liabilities increased mainly due to interest-bearing liabilities of almost 46 million and convertibles and warrants of 43 million arising from that financing. Overall, our financial position remains aligned with our Phase 3 execution plan.

After the first Claret drawdown, we estimate that current working capital is sufficient into the third quarter of 2027 according to our current plan and assumptions. With that, I will hand back over to Christer.

Okay. Thank you, Magnus.

Thank you. 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 21st, and we will report the second quarter in August 19 and the third quarter in the 11th of November.

Of course we will keep you updated on our Phase 3 study expected topline in the fourth quarter. Exciting times, a potential key value inflection point in the last quarter of this year.

With that, I would like to open for the line for questions. Operator, please go ahead.

If you wish to ask a question, please dial pound key 5 on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key 6 on your telephone keypad.

Hi. This is George from ABG calling.

Thank you for taking my questions. I have two, 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.

Thank you.

Thank you, George, for your questions. We do not guide in future-looking costs, but what we have said is of course that we have cash now with current activities into Q3 '27.

As the most of the cash is going to the Phase 3 trial, which is ongoing now full speed. That of course is costly.

That of course in the end of the period, the cost level will go down, but it will be kind of cost intensive the next quarters as well. As I said, our estimates is that we have 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's 75 years old and retired from the board in December, last year, and has as such no involvements 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. The company has no reason to believe that he has any other motives than diversify of his personal financial exposures.

There is nothing new in the company. As you have seen, the Phase 3 trial looks very promising, and everything goes in the right direction as we want it for the company.

It was big big surprise also for us. Unfortunately.

Great. Thank you very much for answering my questions.

Any other questions?

Good morning and thanks for taking my questions. 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?

If so, should we read anything into this in terms of timelines or the final study population? 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 P-CAB drug class?

Those are my questions. Thanks.

Good. Thank you, Arvid, for these questions.

Firstly, I can say that this screen failure rate is according to plan, approximately 50%. That is just what we have expected.

Of course the screening period is more than four weeks, so that's also a delay in that. Not a delay, but that is how the procedure works.

When it comes to studies like this, this is a big study, it's a little bit slow in the beginning. The last months, the pace is increasing significantly if you have done your work as you should.

The pace now with screening is on all-time levels. That is the reason, I would say, that we are screening with very high pace in most of the sites just now.

Therefore, since there are four weeks between screened and randomized, so that is the outcome of that. Nothing to worry about.

It's exactly according to what we have seen and what we have planned. That's actually, I would say, very good.

We are following our plans, and that is of course something that pleased me well. This is very good performance from my team here.

Then when it comes to the other question regarding tegoprazan, as you might have seen then, they announced their results last week during the DDW in Chicago. We were there of course and learned a lot.

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 eight weeks, which is totally in line what I showed you before according to the biomarker and the correlation between acid control and healing.

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. It's perfectly according to our plan how to differentiate ourselves versus the first-generation P-CABs.

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. That is what we will see now hopefully then in the Phase 3 trial coming up in the end of the year.

When we listen and discuss this with our key opinion leaders and the market, there is a good chance that we can deliver that. Of course that will be seen as a relevant differentiation and position for our product.

That is very promising then for the future. Regarding the market dynamics now with two P-CABs, not yet, tegoprazan 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 two players talking about P-CABs instead of one player talking about vonoprazan.

Now we're going to start to discuss the class instead of the unique substances. 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 P-CAB users as well in US. That's of course good for us coming in as number three in US, 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.

I think this just support what we have said before.

Great. Thank you for that.

I'll jump back in the queue.

Okay. Anything else?

Another question?

Good morning and thanks for taking my question. With the financing agreement with Claret in place and the ability to streamline and speed up the start of your second Phase 3 trial, assuming positive results from Healing 1, what kind of timelines could you be looking at for the second pivotal study in terms of start the study and potential timeline to results?

Thank you.

If we now look what we have said that we can start preparing the Healing 2 now and do that in parallel. The more you can do that, normally it's from the timing of signing of the study before you're having first patient into the trial is normally 6 to 8 months or something like that.

Of course that period is not for free, and the more we get there, the sooner we can start. In any case, our intention is to start this in next year, and the more we can work on it now, the sooner we can initiate it.

Then of course we are also a little bit dependent on the results of the Healing 1 study as well. We would like to see that and have the full report from that before starting up everything.

We can actually gain from that kind of information when we finalized the Healing 2 study. Was that an answer on your question, or?

Yes, sure. Thanks very much.

We will come back more on the timings on the Healing 2 later directly either before or after the readout of the Healing 1. You will learn much more about that in the next coming months and year.

So.

I'm also looking if we have any written questions here. There are some questions regarding the sales from one of the founder, but I think I've already responded to that.

Then also regarding the Claret deal. What we can see on the tranches there is that we have four different tranches when it comes to Claret, and the intention with that is that the tranches should be used when we have had value inflection points according to our development steps.

The Tranche B and C are in total €8 million, and the Tranche C is conditional upon positive topline data from Healing 1. Tranche B could of course with that saying could be yeah.

Also the last tranche, Tranche D, is also conditional upon positive topline results of the Healing 2. Definitely very much supporting and aligned with the development steps.

The difference between B and C is that Tranche B is a convertible loan, and the Tranche C is a term loan. That's the difference.

I think we stop there if there are no other questions. I wish you a great day, and I hope to stay in touch and come back with more information regarding the Healing 1 study in relatively near future then.

Thank you very much for your interest in Cinclus Pharma, and have a nice day. Thank you.