Thank you very much, and hi everyone and welcome to Cinclus Pharma's third quarter 2025 earnings call. Here with me today, I also have our CFO Maria Engström, and our R&D Director Margit Mahlapuu.

We will present the latest development from the Q3 2025 and the upcoming news flow. After And and we After this presentation, we will be happy to to answer any questions you you may have.

Before we begin, just some I would like to share a quick reminder with our listeners that during today's call, you may we may make forward-looking statements that involve known and unknown risks, uncertainties, and other important factors beyond the company's control that could cause the company's actual results and performance or achievements to be materially different from expected results, performance, or achievements expressed or implied by such forward-looking statements. Please note that these forward-looking statements made during this call speak only as of today's date, and the company undertakes no obligation to update them to reflect subsequent events or circumstances other than the extent required by law.

With that said, let's go then into the business. You all of the listeners here, not maybe not all, but many of you, you know about our our substance, linaprazan glurate, which is our next-generation P-CAB.

We definitely have designed it to deliver a unique 24-hour acid control, and we also have the fastest onsets of action observed to the date in the class overall. This is definitely a possibility to position the product to become best-in-class.

We have finalized our Phase 2 with very strong results demonstrating high healing rates, especially in the severe erosive GERD patients. Now we have also initiated the the Phase 3 program, which is definitely a very, very big milestone for us as a company, an important step towards an approval later on.

The first patient has been enrolled. You will learn more about that today, and and I would say that the study the Phase 3 first Phase 3 study remains significantly and clinically derisked.

We also have very much supported by clear regulatory strategy and extensive preclinical and clinical validation, the program overall looks very derisked. Our commercial focus, though, remains on patients with with severe erosive GERD, where you find the most highest unmet medical need and where also linaprazan glurate's superior acid control can actually deliver the greatest benefit.

I think that's important, and that is something that we will develop more into the future as well. With this unique profile, unique pharmacokinetic-pharmacodynamic profile provides a strong differentiation versus both PPIs on the market currently, but also against all other P-CABs on the market and in the market in the future.

Also this this unique profile support a specialty commercial model, which also is important for the future commercialization. Also it's interesting to follow, actually, that we see an increasing global momentum when it comes to P-CABs overall globally where it has been launched.

Now we actually see that P-CABs are available in in in over 30 countries. They are also taking over from from PPIs in in the market where they have been launched, and integrated into treatment guidelines for erosive GERD.

It looks very promising for the for the class class overall. Going to the next slide, where we're looking into the correlation between healing and pH level.

As you can see on this slide, there is a clear linear relationship between the 24-hour gastric acid control above pH 4 and healing of erosive GERD. The more intragastric pH stays above 4, the higher the healing rates observed at 4 and 8 weeks.

This relationship is consistent across multiple studies and thousands, thousands of patients. When you look at PPIs, first-generation P-CABs like vonoprazan, or new compounds like tegoprazan, so it's it's it's you can see the relationship everywhere.

You can say that overall, you can see that PPIs, the current standard of care, reach approximately 60% to 70% of acid control, the first generation of P-CABs something between 60% to 85%. We, as a unique next-generation product, we come close to 100% or 96% in in our studies.

It's a it's it's really a unique possibility here. The this correlation reinforces that acid control is the key biomarker for clinical healing, and it's exactly where linaprazan glurate differentiates with with it's with our superior 24-hours control and and the fastest onset of action.

If you just look into the to the next slide, this slide builds on the previous one and illustrates how the correlation between pH above 4 and healing is fully aligned with the data from from from other studies, and especially from vonoprazan US Phase 3 trial. As shown here, from that study, lansoprazole 30 mg maintains pH above 66% of the time, and resulting in approximately 70% healing rate after 8 weeks for for these patients severe patients.

In comparison, in the same study, of the vonoprazan 20 mg achieved 85% pH above pH 4, corresponding to to approximately 90% of healing rate after 8 weeks. It's spot on on the on the line which we just mentioned.

What you also can see then, if you look into our study, or where we have shown 96% pH above 4, and if you plot it in into the same line here, you you see that we it will translate into nearly complete healing for for the most severe erosive GERD patients. This is is very strong data.

The reinforced acid controls is the single most important determinant of of healing, and the linaprazan glurate superior pharmacodynamic profile provides a clear competitive advantage over both PPIs and other P-CABs. Taking this together, this supports our Phase 3 dose selection and underpins our confidence in achieving best-in-class outcomes in in the ongoing Healing 1 study.

Also, I wanted to mention a little bit about the the market overall, which I started the presentation with. Looking into the P-CABs, the global P-CAB market continued to expand rapidly, and driven by strong demand for fast and durable acid control, and that shows also the unmet medical need.

In the US, for instance, Phathom's vonoprazan launch is progressing well. The company projects approximately $170 to $175 million in sales this year, and they already nearly have 800,000 prescriptions filled to date.

Actually, they expect profitability during next year, 2026. We also foresee and expect an NDA of tegoprazan submitted in this quarter by the companies called Sebela, and that further expanding the US category visibility, obviously.

As I said initially, P-CABs are now available in more than 25, 30 markets worldwide, reflecting a broad clinical and commercial adaptation. In Japan, the first adaptor market, P-CABs account for approximately 44% of the entire acid blocker segment.

As as at the at the peak, they were close to $1 billion in in sales only in Japan. In Korea, South Korea, 4 P-CABs already approved, and they represent approximately 23% of all acid blocker prescriptions, and they have a double-digit annual growth.

It definitely continue to displace PPIs. In other markets such India, we're seeing rapid uptake, more than 20 brands launched, 13 licensing deals signed, and treatment guidelines updated to recommend first-line use for P-CABs.

In Mexico and South in Latin America, P-CABs has reached number position number 3 in market within just 2 years, already outpricing traditional PPIs. Everywhere where P-CABs are launched, it looks very promising.

Combined, these trends highlight a clear global shift towards P-CABs, reinforcing the strong commercial potential for linaprazan glurate as the next-generation best-in-class therapy. Let's go in then to to the events during the quarter.

During the third quarter, as we already have mentioned here, we received positive feedback from regulatory authorities allowing us to initiate the the Phase 3 Healing 1 study. We're going to evaluate, as then erosive GERD patients, all grades, focusing on on the primary endpoint where we would like to deliver superiority for the severe erosive GERD patients in 4 weeks.

We have now initiated the Phase 3 trial, which will enroll approximately 500 patients in up to 100 clinical sites in in 7 European countries. We have dosed the first patients, and you will soon learn more about that, and that so that actually happened during October.

That is, of course, an important milestone for us as a company and also for the substance, of course. We have also presented an abstract at the biggest European congress in Berlin, highlighting the positive data from optimized tablet formulation developed for the Phase 3 and also for for the commercialization later on.

In addition, important step forward an NDA, we received positive feedback from the FDA following the CMC meeting, confirming alignment on our manufacturing and quality strategy in preparation for an NDA submission. With that said, I will hand over now to to Margit to present regarding the updates on on the ongoing Phase 3 Healing 1 study.

Please go ahead, Margit.

Thank you. I will give a brief summary of the status of our Phase 3 study, Healing 1.

As Christer already mentioned, the first patient in this trial was screened in mid-September and dosed in early October. In total, we are aiming to enroll about 500 patients in up to 100 clinical sites across 7 European countries.

Our primary endpoint is superiority in relation to comparator lansoprazole in healing of severe patients, which means LA grade C/D patients, after 4 weeks of treatment. We will also monitor a number of key secondary endpoints where the focus is on healing and symptom relief both at 4 and 8 weeks of treatment, and both in patients with severe GERD, which is then C/D-grade patients, but also in all patients, which would mean then LA grade A to D patients.

Overall, the patient recruitment has started really well and is fully aligned with our projections. You see on your right side of the slide the line diagram where the planned recruitment is shown in green and the actual recruitment rate is shown in yellow color.

You see that the actual and planned screening of patients are fully aligned. As of mid-November, we have recruited approximately 10% of patients, which is according to our plan.

As expected in the beginning of the trial, the recruitment is always a little bit slower as the sites are being activated, and then as the trial proceeds, the recruitment also accelerates. The topline results from Healing 1 are anticipated in second half of 2026.

After the topline results have been obtained, we will start second healing study and also maintenance study, which will proceed both in Europe and in US. Now on this slide, you see the 7 countries who are participating in Healing 1 trial.

The countries are listed on your left side. On the right side of the slide, you see where the clinical sites are localized.

Here, every red flag indicates a city where we have clinical sites. In many cities, of course, we have many sites, the number of flags do not correspond to the number of active sites.

We have also decided to add some additional sites who have expressed interest to join the trial, and we expect the regulatory approval for these sites in early spring 2026. Now I leave over for financials.

Thank you, Margit. Then we go to the Q3 financial highlights, and we ended the third quarter with the cash position of 540 million SEK, providing us with a solid runway into Phase 3 program.

Cash flow for the quarter was -49 million SEK, mainly reflecting increased R&D spending as the Healing 1 Phase 3 study is now underway. R&D expenses totaled approximately 46 million SEK, including the first-patient-in milestone payment of 3.5 million SEK.

The R&D represented 86% of total operating expenses, compared to an average of 83% over the past eight quarters, underscoring our continued investment focus on clinical execution. We also saw an increase in number of coworkers, primarily due to the addition of specialized consultants supporting the Phase 3 program and ongoing regulatory activities.

Overall, our operating loss for the quarter was approximately 44 million SEK, in line with expectations and consistent with the company's planned growth phase. Then moving on to the year-over-year financial comparison.

Net sales totaled 9.7 million SEK in the third quarter. This primarily reflects the periodisation of the upfront payment from Zentiva related to the out-licensing agreement for Europe.

The recognition follows the cost allocation across the ongoing Phase 3 program. Operating expenses increased by 14.7 million SEK year-over-year, mainly due to initiation of the Phase 3 study, where the 3.5 milestone for the first patient in was included.

EBIT was -44 million SEK compared with -39 million SEK in the same quarter last year, driven by the higher R&D spend associated with the start of the pivotal study. Financial net improved by 0.7 million SEK, primarily due to interest income on cash holdings and favorable foreign exchange effects.

Net profit for the quarter was -40.7 million SEK, compared to -36.5 million SEK last year, also here reflecting the higher operating cost had for Phase 3 execution. Going to the balance sheet.

The cash in the end of the period was 540 million SEK, compared with 644 million SEK at the same time last year. This follows, of course, our increased R&D activity with the Phase 3 study.

Non-current assets increased by 9.6 million SEK, mainly relating to leasing of new office spaces. Other current assets rose by 24.7 million SEK, driven by prepayments to the Phase 3 CRO, and some CMC activities.

Non-current liabilities increased by 55.9 million SEK. This was linked to the Zentiva contract liability, representing deferred revenue beyond one year.

Current liabilities increased by 50.6 million, reflecting the short-term portion of the same Zentiva contract. Overall, our financial position remains strong with sufficient resources to support the ongoing Phase 3 trial and advance our preparations toward commercial readiness.

Then we go to the shareholder slide, and this slide show the structure at the end of September 2025. The 15 largest shareholder together hold approximately 56% of the company's shares, demonstrating a stable and long-term oriented ownership base.

Our cornerstone IPO investor remain significant shareholders, including Trellix [Impact?] , the Fourth AP Fund, Linc, Eir [Investments?]

, and [Ale Venture?] .

These investors have continued to provide strong institutional support since the IPO, reflecting confidence in Cinclus Pharma's long-term value creation potential. Our founding shareholders, Peter Unger, Kjell Andersson, Mikael Dahlström, and [Müleff?]

Holding and Lennart Hansson collectively hold about 14% of the company, maintaining close alignment with the company's mission and strategy. The cornerstone investors account for roughly 24% of the shares, which together with the founders represent nearly 40% combined ownership.

This consistent and engaged shareholder base provides both stability and strategic continuity as we advance linaprazan glurate through late-stage development and prepare for commercialization. Over to you, Christer.

Thank you. Just to summarize then the financial statements, what we could see when it comes to the run rate, we are financed in 20 into 2027 over the readout of the Healing 1 study, the first Phase 3 trial, which is estimated to be topline results in the second half of 2026.

That looks promising. All the other milestones reflect, I would say, a steady execution across clinical, regulatory, and CMC fronts as well as financially.

This is definitely a strong foundation as advance linaprazan glurate through the Phase 3 trial, first Phase 3 trial here now. Before we just leave this meeting and for questions, I just would like to highlight our upcoming KOL event, December 11th, titled Healing the Unhealed: Redefining Acid Control in Erosive GERD.

The session will feature Professor Prateek Sharma, a world-renowned gastroenterologist, educator, and researcher who has authored more than 550 publications and contributed extensively to advance in the diagnosis and management of erosive GERD diseases. Professor Sharma will discuss the current burden and clinical impact of GERD and erosive GERD, and the strength and limitation of PPIs, the emerging role of P-CABs in improving acid control and healing erosive disease, and illustrative patient cases that underscore real-world challenges and unmet needs.

We look forward to informative session. With that said, I will now open for questions, Q&A session.

Good morning. Thanks for taking my questions.

You mentioned that P-CABs are taking a growing share of the market, and I'm just wondering if that has any implications on future trial designs. You've got a superiority study in Healing 1 versus lansoprazole.

Do you anticipate that there'll be the need to change that should you proceed to the Healing 2 study and use vonoprazan as a comparator, or do you think that trial design still holds up? Thanks.

Good question. What we can say is that, of course, both from a commercial point of view, but also from a regulatory point of view, we will not change the comparator in this.

We will use the same comparator as the other P-CABs has used, lansoprazole, we will have an indirectly comparison. The reason why we stay with PPIs is mostly from regulatory point of view because we need to have the registered products in the market when we set up the studies.

We cannot, from a regulatory point of view, compare with a drug that is not approved, for instance, in Europe. We need to stick with this.

Of course, as I tried also to describe here earlier, is that the key aspect here is definitely the acid control. Since the biomarker with acid control in relation to healing is such strong and linear, the most important is, of course, to deliver the best acid control in class, and that is the argument actually why we also will have a very good and also the rational behind why we will have a very good healing as well as symptom control for these severe patients.

Of course, we are looking into factors in the trial to become superior, of course, in healing, but also in symptom relief. That will be definitely the differentiation factor that is not delivered by the other P-CABs.

We will also include this when we have the data. The hope is to include this in the label, and the ambition is to include this in the label, and that by itself will differentiate also versus the other that do have non-inferior labels.

Thank you. Perhaps if I could just ask one on the market dynamics or Yes, please.

Yeah. what you foresee happening in the period over while you're still running the Phase 3s, with tegoprazan potentially launching in the meantime?

How do you see, particularly in the US, things changing in terms of uptake of relative drugs?

That's a relevant. Firstly, before going into US, we can say in Europe we might be the first P-CAB on the market.

It looks possible, but let's see. That is the first step.

In US, it looks like we can be the number 3. Therefore, we always have planned to have a product that is designed to deliver the best acid control, which is the biomarker, which is the prove to have a reason to be in the market.

We definitely will focus all on the severe patients that we still have an unmet medical need, and that will be the case also in the future. You see, the best P-CAB what it seems to be when it comes to acid control is vonoprazan except for ours, linaprazan.

In tegoprazan, it looks like they have a little bit less acid control compared to vonoprazan. In that case, they will not add an additional to vonoprazan.

Of course, when we get in, our ambition is to become best-in-class, and there will always be patients that are not healed by the first-generation P-CABs, but also we know that market is very dynamic. Also in vonoprazan studies, 25% of the patients relapsing within 6 months, and it's higher figures what we understand in tegoprazan.

The patient will come back to the physicians again after relapsing. In that position, you have definitely a switch possibility.

Since there are so many patients, just talking about the severe patients, we're talking about in US 4, 5 million patients, and definitely there will be a space for a superior acid control product even though it will not be first. The market will be there and definitely is still will be a very big dynamic market when we enter.

Okay. Thanks very much.

Thank you.

Hi. This is George.

Thank you for taking my questions. I have two.

Besides for modeling a financial runway into 2027, could you provide any additional guidance on how opex will increase as the Healing 1 trial ramps up? I'm particularly interested in the facing between Q4 and Q1.

Secondly, you keep hear Phathom's share price has really rallied lately, while the Cinclus share is relatively flat since June. You are obviously at a different stages, but still it would be interesting if you are able to share any thoughts or comments about that.

Thank you.

Yes, of course. Normally, as you have seen, as we have guided already, we are financed with current cash into 2027.

As you see, the burn rate now we have in Q3 was a little bit less than 50 million SEK. That, of course, will differ a little bit from quarter to quarter depending on the payment schedules for the CRO.

I would say that is approximately 50 million what you would expect. That is if you look into it, but it will differ a little bit over quarter to quarter.

That is the first answer. The second answer on Phathom's stock price.

That, of course, is very problematic for me to answer. What you could say is that it's interesting to see.

Thanks to their advancement and actually improvement in the launch now, the market is obviously looking to that, and that's the reason why you increasing. Of course, the gap between their market cap and our market cap has increased.

We have now delivered from what we have said that we should deliver. Now we have the Zentiva deal in hand, and the collaboration looks very promising.

After a huge due diligence, they actually choose our substance, which is definitely a validation. We have now executed the start of the clinical study, the Phase 3, and that also looks going according to plan, which also is good.

We foresee readout of that trial in the second half of next year. There are so many different signs together with the improvement and the increasing awareness and prescriptions of P-CABs overall in the world.

I would say, time will come also for us. It's definitely very problematic for us to say.

Obviously, we are delivering what we're supposed to do, and eventually, I suppose that we will also gain from that also when it comes to market cap.

Great. Thank you.

Hi, team. Thank you for taking my question.

Just a quick one on my side. You mentioned about possible additional sites to be activated.

How many are we talking about, and will these also be in Eastern Europe?

Yes. When you do a clinical studies, always you need to be planning for the next steps behind the corner, and that's what we do.

We make sure that we deliver the results in the second half of 2026. This is just a mitigation.

We talking about 10 sites, Margit? 10 to 15 sites, approximately, additional?

Margit, can you help me here?

Yes, and also for regulatory reasons, we primarily want to open new sites in the countries which are already included in the trial just because the regulatory process will be faster.

Just to mention, we still very confident with current sites. We will deliver the second half of 2026 the topline.

This is just more an insurance so that we always are prepared if something happens in the future. It's not nothing more than that.

Yes.

Got it. Thank you.

Let's see. We have some questions from the written questions.

We have something from China. What happens in China?

Do you have any response from Chinese patients yet? No.

We are waiting for the price and reimbursement process in China, which should come during this year. Normally it takes up to a year normally it takes a year to get price and reimbursement in China, and this is the case also here.

We expect to have the launch during next year in China. These are the plans for China.

Then the indication if there are any indication that we should get superiority in Phase 3. I think it's important to remember here our primary endpoint is superiority versus PPI in the first Phase 3 trial.

We have powered the study very high power, the chances to reach that, they are very, very high and good. Therefore, definitely and that is not only based on indications.

We are also basing that, of course, on the Phase 2 trial results that we had really good healing data already there with delivering the post-hoc analysis a superiority versus PPI, and now we're going to repeat that. Also it's based on the biomarker which I mentioned regarding the acid control.

It's also based on clinical data from other Phase 3 trials like vonoprazan trials. These together, we have put together the chances to reach this, and made a very conservative diagnose for this.

It looks very, very promising. We are confident that we can reach superiority in the Phase 3 trial.

Yes, and just clarification of the KOL event. That's an online event, absolutely.

We will send out the press release with the contacts and the links for that event in the next coming weeks. You will have it also.

It's an online event open for everyone. I think we stop there for now.

If there are no other questions, I thank you for your interest in Cinclus Pharma, and wish you a good day. Thank you very much.

Bye-bye.