Thank you, and hi everyone, and welcome to Cinclus Pharma second quarter 2026 earnings call. I am Christer Ahlberg, and I'm CEO of Cinclus Pharma.

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 P-CAB. That substance offers sustained, around-the-clock acid control that distinguishes it from the current standard of care with proton pump inhibitors, the PPIs, and also all other P-CABs available in the market and also into development in the market.

It's also for severe erosive GERD. This patient populations 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. 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. Our Phase 3 program, Healing 1, began in September 2025, and I'm very pleased to report that it has completed enrollment totally now.

In early July, we announced that we had exceeded protocol-specified target number of patients. That was a very good news for us.

Healing 1 topline results are expected in the fourth quarter, already communicated before, of this year, which, of course, could give us a potential major value inflection point for the company. Our program is derisked at this stage.

We have a robust clinical data package, alignment both from the US FDA and the European EMA, our regulatory strategy, and 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 10-second 10-second biggest pharma company in China.

We are, although, restricted to give 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. We are, of course, excited that we have seen the first commercial launch of linaprazan glurate globally, and it's, of course, a very important validation of the drug.

We see that the first-generation P-CABs are rapidly gaining traction. P-CABs 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 P-CABs 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.

If we look into the enrollment complete of the Phase 3 study, we are very pleased with the execution of the first Phase 3 study, Healing 1, 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 at that time, we had randomized 521 patients, exceeding our protocol-specified target of 501 patients.

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

That'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 four weeks of treatment. Key secondary endpoints cover healing, of course, and symptom relief through four weeks, but also through eight weeks for both C and D patients, but also, of course, all patients, all grades as well, A, B, C, and D.

The study will be followed by our second and final Phase 3 study, Healing 2, that will also evaluate maintenance therapy and will be done at clinical sites in both Europe and in US as well. Healing 2 is planned to initiate following Healing 1 topline results.

This slides highlights our Healing 1 progress. We screen the last patient in June and randomized last patient in July.

The remaining milestones prior the topline results are last patient treated that we expect within 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 finally readout that we expect during the fourth quarter of the year.

We have good visibility over the remaining timeline of the study. This slide you have seen before, but it'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 P-CABs.

That is the central scientific argument for the linaprazan at this stage. Acid control is the biomarker that drives healing in this disease, 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 a aim and objective when we have developed the product from the beginning. This slide illustrate the number of hours pH in the stomach is below pH 4 with the treatment alternatives available in the market and over the decades and the history of the development of this kind 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. 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 pump inhibitor that came to the market in the end of '80s and the beginning of '90s, here you can see reduction between 7 to 14 hours with PPIs below pH 4. That, 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. These drugs are important for companies and when they are developing the company.

Also when we see now the next step in this evolution, you see that the first generation of P-CABs were launched in the 2015 and now in 2024 in 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 became the most sold drug in Japan.

With a close to $1 billion in sales only there. Of course, acid control improvement matter to actually build a market and to build companies launching this 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 1 hour per day. This is a major improvement to all existing treatment alternatives on the market and in the development, highlighting a significant market potential, as you understand then.

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 time and healing of these patients, we also wanted to control this and double-check if it works also for P-CABs, and the last studies that has been performed, the Phase 3 trials been 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's actually interesting to see when you plot in this results into the curve that we showed you before, the biomarker curve, it's spot on.

It's perfectly spot on related also to this curve. If you just look at the acid control of lansoprazole is 63% after 8 weeks.

In the results of the clinical studies of the Phase 3 clinical studies of tegoprazan and vonoprazan in US, Europe, they came to conclusion of 68% to 72%, and that's perfectly on the line of the biomarker line here showed you before. Going further then into tegoprazan, they have a acid control of 75%, and actually, their clinical data showed 83% in the Phase 3 trial after 8 weeks of the C and D patients.

If you just compare 75% into this curve, you see it's perfectly on the line of 80%-plus in healing. Also looking into the vonoprazan, they have a little bit higher acid control up to 85%.

If you look at their clinical data from the Phase 3, they have 91.7% of the C and D patients healing after 8 weeks. It's also perfectly spot on the curve as well.

You can really predict outcomes with this data, with this curve. Therefore, it's 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 when we know absolutely in our Phase 3 trial.

Of course, our ambition is to have, in absolute figures, also the best healing rates for the C and D patients. 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 2 trial, delivered 55% delta in absolute percentage figures, 93% versus 38% of the PPIs.

That's 55% units in difference. If you look into the other P-CABs, 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 comparing with, and that's the same as vonoprazan and tegoprazan has done. 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, 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. 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. I think I stop there, and let's go into some financials, and I hand over then to you, Magnus.

Thank you, Christer. If you're turning to our second quarter results, we ended quarter two with a cash balance of 388 million SEK, which is including the structured financing agreement drawn under the Kreos facility in quarter one this year.

The cash flow in the quarter amounts to -88 million SEK, which reflects the continued focus and our investment on Healing 1 execution and its upcoming milestones. The R&D expenses remained a clear driver of our cost base at 89% of operating expenses in quarter two, compared with the average of 87% over the prior four quarters.

If you're looking at the year-over-year comparison for Q2, net sales were almost 2 million SEK, and the revenue consisting primarily of the licensing income from the Sobi partnership for commercialization of linaprazan glurate in Europe. The revenue from the Sobi deal, which include an upfront payment of €30 million in Q2 2025, is being periodized across the Phase 3 studies.

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

If you look under financial net line, we recorded 16.3 million SEK, and that's consisting mainly the revaluation of the structured financing of the Kreos facility, as well as interest in bank and interest payments to Kreos facility, mainly. Net loss for the quarter was almost 79 million SEK and is driven by the higher R&D expenses from the ongoing Phase 3 study.

If you look at the balance sheet, the non-current asset has increased, and that's primarily reflecting the leasing liabilities for the new office premises. 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 SEK, with the 86 million structured financing drawdown partially offsetting the increased R&D expenses as the Phase 3 activity ramped full execution. Non-current liabilities decreased by almost 30 million SEK, mainly representing the contract liability from the Sobi deal, which is periodized beyond one year.

The current liabilities increased by 100, and they're primarily driven by the structured financing in debt, convertibles, and warrants, plus a short-term contract liability from the Sobi deal. With this, I hand back over to Christer.

Thank you, Magnus. Thank you for these figures.

That brings us to the end of our formal remarks. Before we open the line for questions, a few important dates ahead.

The Q3 results will be reported on November 11th this year, and the Q4 results will be reported on February 17th next year, 2027. Of course, we look forward to keeping you updated on the remaining steps of the Healing 1 study and results of the fourth quarter of this year, the defining clinical milestones ahead for the company.

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

Hi. Thanks for the presentation, and thanks for taking my question.

I have one on Healing 1, you ended up randomizing 523 patients versus 501. Was it simply because there was patients being still in screening when you reached the target, or was that a deliberate decision, and does it have any meaningful impact on the study power in the end?

It's a very easy question. We had patients still in screening when we reached it.

Of course, from an ethical point of view, you want to give all patients the possibility to be enrolled. Nothing more than that.

Okay. That makes sense.

Maybe just a second on Healing 2. You've started preparing for the trial.

How much of the work can be done before the Healing 1 readout? I guess the question being how quickly after the results could you start the trial and enrolling patients?

Of course what we do now is that we are preparing the protocol for the studies. We are working with picking the right CRO, we are having the requests out there.

Then, of course, we have also dialogue with authorities, we make sure that we have everything in place as fast as possible, 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 Healing 1. Also, one advantage is that we have now, of course, is, as you have seen, we have executed this Healing 1 study very fast, recruitment time of 9 months, I would say, more than 500 patients.

We have a very good collaboration with both the 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, of course, good for the feasibility of selecting the sites also in next study, which may make it maybe hopefully, and that's our ambition, is to have a more flying start with higher recruitment early stage in the study. Because otherwise normally it takes some kind of long time before you're up and running with the sites and recruitment.

That's 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 Healing 2.

Okay. Thank you very much, and that's all for me.

Good morning, and thanks for taking my questions. The first question is on Healing 1.

Now that enrollment is complete, how much visibility do you have on the evaluable 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?

Then my second question is on Healing 2. 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 Healing 1? Those were my questions.

Thanks.

Okay. The first question is, of course, a little bit early to say yet now.

Of course, still it's blinded, we have no insight on results or anything like that as you know. That is totally blinded, and then we will not know anything about that before we have the results in Q4.

We should say that we have not closed the database yet. The study is still ongoing, 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 as what we can see now and what I can say now.

That is the first question. Next question is, you asked, Arvid, regarding the differences between Healing 1 and Healing 2.

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 Healing 2 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, but overall, we do not expect to have another outcome in the Healing 2 versus the Healing 1. From an analyst point of view, I would say the Healing 1 study is the most important value inflection point.

Of course, in the Healing 1, we have two doses of linaprazan glurate patients. In the Healing 2, our ambition is to go with only one dose, so that might be the biggest difference.

Otherwise, the endpoints will look similar, and what we are measuring. Definitely we do not expect to see any differences here.

Did that answer your question? Okay.

Let's go to other questions. Are there other questions from the audience?

Okay. I think we have also some written questions, which I can which which I can cover.

There is a question regarding the cost of Healing 1, if all the cost has been taken now so the rest cash can be used for the preparation of Healing 2. Yes.

No, it's not 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 Healing 1, but also some of the preparation for the Healing 2.

That is already communicated, and and everything goes according to plan. Also thoughts regarding Nasdaq listing.

I assume that means in in US. We have not We have of course, this is something that you always have in mind, I mean especially depending on if you're going to have a commercial commercialize yourself in US, then of course, that could be an an a solution.

There are no decisions or or anything on on that yet, so that's much too early for us to say anything about now. We have another questions regarding if the Healing 1 if the results of Healing 1 will have an impact on the design of the scope of Healing 2.

It's actually the same question as Arvid just had raised, and I would say of course, it could be fine-tuned, but overall the overall it it's more or less the same design, with exception that we would like to to reduce one dose of the linaprazan glurate. Reduce one of the dose dosing arms, only one dosing arm.

Then we had another question regarding vonoprazan, if they cannot just deliver twice daily or three times daily to overcome the 24 hours gap of acid control. It's not that easy, I have to say.

If that Firstly, what we could say is that we have a better acid control once daily compared to what vonoprazan has. We have the best acid control overall.

What we also see, though, if if they try to split their dose into twice two times per day, they don't gain anything. What we have seen in their own in their own studies, meaning that there is no reason to split the dose for them.

This 24 that their once-daily dose is what they have used in in the clinical trials, and what they have used in in the registration as we have now, and what they are approved for. We see that when we split the dose, those though, our if we have 100 mg as once once once daily, if we split that into 50 x 2, we actually, even though once daily is is we are we are outperforming the other P-CABs with 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 over the 24 hours, but we also reduce that we also make sure that we push all the patients above pH 4 24 hours, not only the 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 to to to help them as well. That's unique.

That is we have not seen anyone that can actually help these patients doing that with with with a product. Actually, the severe patients is also the patient group that definitely have the unmet medical need.

This is not only patient that suffer and complaining about some mild heartburns once in a while after after a bar bar round in in the day before. This is patients that really suffer from this.

They they they cannot they have day-to-day business, they cannot their quality of life is very, very low. They cannot sleep during nighttime.

They they get and it's and also they have a risk of progressing to cancer if they don't heal, these patients. This is a patient that really suffer from from that the acidic content in the stomach going up in the esophagus, and really frying up the mucosa there.

This is not nothing to be compared with with with some mild mild heartburn that some some actually might think that this this disease is about. This is a really tough disease, have a huge impact on quality of life, and actually risking that the patients' long-term health and actually progressing to a risk of progressing to cancer.

That these patient population is the patients that we want to help with this with this drug. We have a chance actually, once for all, to to help these patients that no one has done before.

Okay. Any other questions after today meeting?

Otherwise, I will stop there, and thank you for the time. I'm really looking forward coming back to you during Q4 with the results of our Phase 3 trial.

Let's stay in touch. Thank you very much for today meeting.