Zealand Pharma A/S/ADR (ZLDPF) Q2 2026 Earnings Call Transcript

Thank you, everyone, for joining us today to discuss Zeeland Pharma's results for the first half of 2026.

The related company announcement is available on our website at zeelandpharma.com. As outlined on the slide, I would like to remind listeners that during today's call, we will be making forward-looking statements that are subject to risks and uncertainties. Turning to today's agenda, joining me on this call is Adam Steensburg, President and Chief Executive Officer, David Kendall, Chief Medical Officer, and Henrietta Venneke, Chief Financial Officer. All speakers will be available for the Q&A session. I'll now hand the call over to Adam.

Thank you, Eric, and welcome, everyone. In the first half of 2026, we delivered on the key objectives we set out at the start of the year and drew significant progress across our pipeline. I'm pleased to walk through those accomplishments today. Starting with Petrenatide, we reported positive Supreme 1 results, demonstrating double-digit weight loss with a tolerability profile consistent with placebo. On the back of that data, we confirmed advancement into Phase 3 registrational trials initiating in the second half of this year. So full speed ahead. On Cervalutide, our partner Böger Ingelheim reported positive Synchronize-1 and Synchronized Massal results, delivering competitive weight loss and targeted liver fat reduction, pointing to the potential for sustained improvements in metabolic health. What is compelling is that Cervalutide targets the fat that actually drives poor metabolic health. And I believe that that is an increasingly important value proposition as this category matures. BI also solidified their commitment and excitement around Servilotype by announcing an expansion of the development program with four new and additional Phase IIIb trials initiating in 2026. On the early pipeline, we have initiated a Phase 1b clinical trial in plaque psoriasis with CP9830 and a first in human clinical trial with our GIP agonist CP6590. So real momentum in building out the next wave of innovation. In May, we initiated a 200 million US dollar share buyback program, a statement for our strong commitment to returning capital to shareholders when we have the flexibility to do so. And finally, as announced yesterday, we monetized our royalty rights to a non-strategic asset through the 100 million U.S. dollar agreement with Royalty Pharma for Rosfatide, which will be redeployed back into our strategic priorities and long-term growth initiatives. This has been a very strong half year and execution across our business, and we remain focused on advancing our programs to get these medicines to patients as fast as we can. Before I hand over the call to David, I want to briefly mention what we witnessed at the American Diabetes Association meeting in June this year. The messages on key unmet medical needs in chronic weight management was clear. tolerability, treatment persistence, and patient experience. ADA opened with a symposium on amylin that spoke directly to these gaps. And what struck me the most was not the data, it was the framing. The speakers, all key opinion leaders in their BC space, laid out a hypothetical treatment paradigm for chronic weight management. This felt like a real shift in how the field is starting to think about treatment sequencing. And I think it maps closely to how we see the role of petrinside. For the majority of patients, the proposal was to start with a long-action amylin as a first-line therapy. The logic here is simple. Why start with a very cumbersome treatment when a more benign one can deliver the weight loss? most patients are actually after. For the patients with higher BMI and or complications at GLP-1 with established evidence or higher efficacy dual or triple agonist could be the option. Then if those paths fail short of the patient's needs, escalate to combination therapy or biotic surgery. This narrative is now being proposed by the broader scientific community as a logical way to think about chronic weight management. What I find validating is that this is exactly the value proposition we have been building for Petrillion Tide, a benign, highly tolerable therapy delivering double-digit weight loss for patients starting their weight loss journey with the option to add or escalate if need of more. With that, I will turn over the call to our Chief Medical Officer, David Kendall, to walk through the progress across our pipeline. David.

Thank you, Adam. I will start with an overview of our pipeline. The first half of 2026 has been incredibly exciting and was one of the busiest six-month stretches in our company's history. We shared initial Phase I data for our novel KV1.3 ion channel blocker, reported Phase II results for petrolentide, and as Adam mentioned, presented these data at the American Diabetes Association's scientific sessions. And our partners at Beringer Ingelheim presented results from two Phase III studies with cervidatide. Beyond these readouts, we continue to advance our pipeline in other important ways. We confirm plans for initiation of a registrational phase 3 program for petrelentide as monotherapy, and we will initiate the phase 2 Zenergy trial, evaluating the petrelentide and asepatide combination. As Adam also mentioned, we advanced our early stage portfolio, including both the novel KV1.3 ion channel blocker and our GIP agonist. Furthermore, for our rare disease programs, the Phase III EASE-V trial for glopaglutide in short bowel syndrome continues to progress well, and we successfully completed the EASE-II and EASE-III extension trials, which will support the long-term efficacy and safety of glopaglutide. We look forward to sharing these data at scientific congresses in 2027. We have delivered a remarkable string of clinical milestones in the past six months, a real testament to the incredibly committed and talented teams we have at Zeeland Pharma. Let's now turn to our Phase 2 Zupreme 1 results, which we firmly believe support the unique potential of Petrolentide as a future first-choice therapy for people living with obesity. Petrolentide delivered double-digit weight loss with no apparent plateau over 42 weeks of treatment in a study population that was generally balanced between women and men. What stands out in these data is not solely the clinically meaningful weight reduction, it is the tolerability profile observed. More than three-quarters of the gastrointestinal events reported with betrelentide were mild, were transient in nature, and occurred predominantly during dose escalation. More importantly, up to 98% of participants successfully escalated to their target maintenance dose. When looking at the adverse event rates, in particular the reports of diarrhea, constipation, and vomiting, they are strikingly similar rates in those treated with petrelentide as compared to those receiving placebo treatment, supporting a GI tolerability profile that is comparable to placebo. Together, these data point to the potential of Petrelentide to fill a critical gap in chronic weight management, namely a highly tolerable therapy that delivers the weight reduction that the majority of those seeking weight management desire, with exceptional tolerability and the potential to support long-term adherence. With these data in hand, we and Roche have made the decision to advance Petrelentide monotherapy into a Phase III registrational program on track to initiate later this year. We look forward to sharing more details around that program once those studies begin. We are also on track to report top-line results for the Phase 2 Zupreme 2 study with petrelentide in participants with overweight or obesity and coexisting type 2 diabetes in the second half of this year. Zupreme 2 has enrolled approximately 200 adults with a balanced gender representation, comparing three doses of petrelentide with placebo over 28 weeks of treatment. The primary endpoint is percentage change in body weight from baseline, while key secondary endpoints include change from baseline in hemoglobin A1c and changes in cardiovascular risk markers, including fasting lipids. We are also expanding our petrelentide franchise with the initiation of the Phase II Zinergy trial, evaluating petrelentide in combination with antisepatide, Roche's potential best-in-class GLP-1 GIP receptor dual agonist. Zinergy is a comprehensive dose-finding study designed to identify an optimized ratio of petrelentide and antisepatide. The study includes six arms, three different dose regimens of the petrelentide and antiseptide combination, along with petrelentide monotherapy, antiseptide monotherapy, and placebo treatment groups. Participants will receive petrelentide and antiseptide as separate injections, allowing us to explore multiple combinations before committing to a fixed-dose, single-cartridge, co-formulated combination in Phase 3. This study will enroll adults with obesity or overweight and at least one weight-related comorbidity with the primary endpoint of percentage change in body weight from baseline to week 40. As we have seen in separate phase 2 studies, patrelantide's impressive tolerability profile paired with antisepatide's strong efficacy makes this combination a compelling and natural next step in the development of our portfolio. We believe it has the potential to deliver both substantial weight loss and improvements in cardiovascular risk markers while maintaining a competitive tolerability profile for patients who will benefit from additional weight loss efficacy. Turning to cerviditide, our partner Beringer Ingelheim reported detailed results from two phase three trials at the American Diabetes Association scientific sessions this year, and I would like to spend a moment on these exciting results. The 76-week synchronized one trial in participants living with overweight or obesity met its primary endpoint, with cerviditide delivering up to 16.6% weight loss from baseline compared to 3.2% with placebo. What we would like to further highlight today is data from the pre-specified MRI sub-study that looks beyond the top-line number and assesses body composition following weight loss, a view of specifically what kind of weight is actually being lost. Relative to baseline, cervidutide achieved up to a 34% reduction in visceral fat, the metabolically harmful fat that sits around the organs and drives cardiometabolic risk, alongside a 63% reduction in liver fat content. Lean mass loss accounted for no more than 11.3% of the total tissue mass change at the highest dose. This is a body composition profile we believe supports sustained meaningful improvements in metabolic health. This is a differentiation point we believe will become increasingly important as the field moves beyond weight loss alone as the benchmark and focuses on overall improvements in metabolic health status. The 48-week synchronized MASLD trial in participants living with overweight or obesity and metabolic dysfunction-associated steatotic liver disease, or MASLD, with evidence of inflammation and or fibrosis also met both of its primary endpoints. Liver fat normalization was achieved by 6 out of 10 participants treated with cervidotide for 48 weeks, with an associated mean weight loss of up to 12%. On tolerability, what we're seeing is broadly consistent with what is expected across GLP-1 based therapies. It is worth providing some additional context here, as the synchronized program used a stricter titration protocol than is typical in clinical practice or in many other clinical trials, with limited flexibility for slower up titration, dose adjustment, or temporary interruption of study drugs. In a number of cases, participants were required per protocol to discontinue rather than adjust treatment. We and our partner, Beringer-Ingelheim, believe this contributed to both the GI event and discontinuation rates observed. We were also particularly excited to see Beringer-Ingelheim expand the cervidotide program with four phase three studies, including Elevate Liver, assessing preservation of cardiac structure and function in people with MASLD or early MASH. The newer programs, including the liverage study, incorporate more flexible, patient-centered titration strategies to better reflect real-world use and support tolerability. Altogether, this reflects the breadth of opportunity for cervidutide across the cardiometabolic and liver disease spectrum, a focus beyond brute force weight loss and toward overall metabolic health. lastly i want to mention that synchronized 2 and synchronized cvot the long-term cardiovascular outcome trial represent key upcoming readouts both expected this year we look forward to those readouts as we continue to believe cerviditide is well positioned as a highly differentiated option addressing obesity and its most serious metabolic consequences turning now to our early stage immunology candidate zp9830 our novel kv1.3 ion channel blocker kv1.3 is a potassium ion channel selectively upregulated on effector memory t cells the cells that drive much of the tissue damage in autoimmune and inflammatory diseases through the release of pro-inflammatory cytokines blocking kv1.3 may dampen specific pathogenic immune activity while preserving the protective function of the broader immune system. That selectivity is what makes ZP9830 a genuine pipeline and a product opportunity across a broad range of cell-mediated autoimmune diseases. Building on the positive Phase 1a single ascending dose results, we have now initiated a Phase 1b trial in approximately 30 participants with plaque psoriasis. This eight-week trial will evaluate the safety tolerability, pharmacokinetics, pharmacodynamics, and clinical efficacy of ZP9830 with treatment emergent adverse events as the primary endpoint. We look forward to progressing this candidate through phase 1b and to report top-line results from the ongoing multiple ascending dose trial, part of the phase 1 trial, later this year. The Zeeland teams are both energized and excited with the clinical development progress we've made thus far in 2026, and I look forward to providing additional updates going forward. And with that, I'll turn the call over to our Chief Financial Officer, Henrietta Vennecke, who will review our financial results for the first six months of 2026. Henrietta?

Thanks, David, and hello, everyone. I'll start by focusing on the strength of our balance sheet. We ended the first six months of 2026 with a significant cash position of 14.5 billion DKK. As a reminder, while we have recognized the revenue from the phase 3 initiation development milestone of 3.7 billion DKK, we will only receive the payment from us later this year when we actually start the study. We continue to focus on active balance sheet management. This is evidenced by the launch of the 200 million US dollar share buyback program in Q2 and the announcement yesterday of the 100 million US dollar royalty monetization of a non-core asset via the agreement with royalty pharma for Rusparteit. I'm very pleased with this agreement which converts a future potential royalty stream into immediate capital And we will continue to leverage our strong financial position to invest into future growth opportunities in line with our strategic priorities. Beyond our near-term commitment with the existing clinical pipeline, this means expanding our capabilities to build a leading pipeline for the long term. drawing on our deep expertise in metabolic health and peptide innovation and complementing this with external innovation through partnerships that allow us to expand into other modalities, just like the partnership with OTR therapeutics on small molecules. Moving to the income statement for the first six months of the year. Revenue was $4.5 billion DKK, driven by recognition of the Phase III initiation development milestones of $3.7 billion DKK and the first anniversary payment of $798 million DKK from the collaboration and Leisner agreement with Roche. Operating expenses totaled $1.2 billion DKK. The vast majority of that was dedicated to research and development, reflected continued investment in the petroleum-type franchise, including preparation for the Phase 3 program with patrillion-tide monotherapy and the Synergy Phase 2 combination trial that David described earlier on. Expenses also reflect increased investments into our research program, clinical advancements of early stage assets, as well as the ongoing Phase 3 with blepid 2 glutide. Net financial items amounted to a positive 292 million DKK for the period, reflecting exchange rate adjustments on our USD-dominated holdings and interest income for our investments in marketable securities and cash equivalents. As a result, profit for the first six months of 2026 was 3.5 billion DKK. Now let's briefly move on to the outlook for the full year There are no changes to our financial guidance Of 4.5 billion DKK in collaboration revenue for 2026 And we continue to expect operating expenses In the range of 2.7 to 3.3 billion DKK Mainly driven by R&D activities And with respect to the royalty sale agreement With royalty pharma for Rusparteid just announced yesterday, we will receive 50 million US dollars in cash in Q3 and the remaining 50 million US dollars at the first anniversary of closing of the agreement. And I would like to highlight that the anniversary payment is not linked to anything else than time. And with that, I will turn the call back to Adam for concluding remarks.

Thank you, Henriette. Leveraging our momentum, we look forward to several important milestones and catalysts ahead in 2026. These include data from additional key trials in the synchronized program with cervidotide, continuous clinical advancement of petrinitide franchise, and the progress across our early states programs. With that, thank you all for your attention. I will now turn over the call to the operator, and we'll be happy to address your questions.

Thank you. We will now begin the question and answer session. If you wish to ask a question, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. We will take our first question. The first question comes from Hackon Hembro Jorgensen from Danks Bank. Please go ahead, your line is open.

Great, thanks for taking my questions. On the combination product of pretilintide and insipatide, can you clarify your dose ranging approach? Is pretilintide held constant around its maximally effective dose while insipatide dose altercation varies or are both components varied? And secondly, on the KV 1.3 channel blogger, how should we expect the future progression of this molecule to unfold? Will you run multiple phase one indications in parallel or wait for more data before deciding where to focus? Thank you.

Thank you, Hogan. On the combination study, which, of course, we are extremely excited to get going and progress as we understand how important this could be for the future patient care. As we have discussed a few times before, the profile of a combination between an amylin and a GLT-1-GIP actually holds the potential to address several different patient segments, including those living with the highest degree of obesity could also be patients who lives with both obesity and type 2 diabetes and other situations. And the specific combinations and which molecules we titrate and the specific titration ranges is something we will probably have to keep a little bit preparatory for some time as we build a very competitive profile for this combination product for the future. But as we have mentioned a few times, we could consider quite a number of different patient needs to be addressed by this combination product. And we are extremely excited about getting it going and progressing it together with Roche. On KV1.3, it's very clear, as David also mentioned, it has this pipeline in a product potential because KV1.3 and these T-effector memory cells are so central to the immune reaction in autoimmune diseases, but actually also in certain inflammation seen in metabolic diseases, we would definitely envision a broader program as we get later into development. but it's too early to comment on which indications we specifically will pursue beyond psoriasis. Thank you, Hogan. Thank you.

Thank you. We will take our next question. And the question comes from the line of Mowit Ransal from Wells Fargo Securities. Please go ahead. Your line is open.

Thank you very much for taking my questions. So I have a couple of questions, one on servo and then one on patrinotide. So on servo, the key question when you talk to doctors is that glucagon agonism does have a benefit in like liver fat reduction and all that. However, the question is, would you be able to show a differentiation against a GLP-1 or GLP-GIP based on the traditional MASH endpoints because they are more, you know, histology-related endpoints. Or you may have to come up with some unique endpoints or an outcome trust like Lily is doing something of that sort that you may have to do to prove that this is GLPGIP plus kind of drug. Secondly, on patenotide, so one key theme, especially looking at the data for BCT was that doctors love the fact that you could actually tighten only once and then you could get to a tisipatide-like weight loss. So for Petri, given the safety profile is pretty good here, do you see a possibility on differentiation on the dosing, dose titration part, which would be very appealing to the primary care doctors? Thank you.

Thank you for your question. And I will just touch upon the second question on patrinotide and then hand over to David on cervirutide. But on patrinotide and titration, I think it's actually an important thing to think about that when we look into how patrinotide is being dosed, we actually see this more as dose escalation. We have just gotten so used to talk about dose titration when we think about the GR3-1s because they are so intolerable molecules, the GR3-1s, that you have to carefully titrate them. You go up in dose, then you find out the patients can't tolerate it, and you step down in dose. Then you try again a few weeks later, and so on and so forth. That's a very, very cumbersome journey to get to the effective doses that delivers the weight losses that people like to talk about. With betrinotide, as David mentioned, people can follow the dose escalation, meaning that you don't need to titrate up and down. So it's a very simple stepwise approach, as you see with many general medicines in other categories. And if you think about our phase two study, you also saw quite significant weight loss at the lower doses. So I think as a field, when we start to talk about the amylines, we need to get used to talk about dose escalation rather than titration. It's two very different situations between the amylines and the GLP-1s. So, David, will you talk about CERVO and the glucagon component for mass resolution?

I'm happy to, Adam, and thanks for the question. I think you hit on one of the key points, which is the glucagon agonism that's added to the cerviditide molecule. Clearly, we have a belief, and our Berger-Ingelheim partners have a belief, that the glucagon signal and its ability to alter specifically how free fatty acid is trafficked and metabolized in the liver is distinct from the pure incretin mechanism or GLP-1 agonism. I think one has to look no further than the phase two data that were reported now two years ago at the liver meetings in Europe where the improvements in fibrosis and resolution of MASH with cervidutide, at least based on those phase two data, are what we would consider best in class in terms of potential. That does not mean that other mechanisms, GLP-1 agonism alone with senaglutide, GLP-1 GIP agonism with trazeptide, will have an effect, presumably much of that driven through reductions in body weight specifically. But we and our BI partners firmly believe that that glucagon signal has a critically important role in what is the primary insult that is driving the trafficking of fat into the liver, in this case, modifying that through the glucagon signal. The preliminary results from synchronized mass hold also showed that six in 10 had resolution of liver fat, albeit in a lower risk population. So I think those are two very important data points that suggest that while weight reducing therapies alone are very effective, that adding this glucagon signal may carry very important additional effects at specifically targeting not just MASLD, but MASH, the F2, F3, and ultimately F4 populations. So, obviously, more to come with the leverage program, but exciting data to date, we believe, supporting this unique mechanism. Thank you very much.

Thank you. We will take our next question. Your next question comes from Alana Shamsi from Jefferies. Please go ahead. Your line is open.

Hi, thank you. Thanks for taking my questions. Firstly, on amylin therapies, interested to hear if you hear of any illegal or unapproved use of amylins, including petrolentide, in the same way that's been seen for drugs such as retrotutide. And then secondly, on GIP, could you walk us through how you're thinking about the development strategy from here? Specifically, what do you see as the most attractive commercial positioning for a GIP-based therapy? And what could combination trials look like?

Thank you for your questions. I'll just address the first one and then hand over the question on GIP to David. We have not heard specific illegal use or compounded or imported use of petrinetide. Of course, it's something we monitor closely as we have seen these things with other products. So it's something we have to monitor closely going forward. David, will you take the second one?

Yeah, happy to, Adam. And as regards amylin, it's worth noting that pramlentide approved simulin has been available, indicated as an adjunct to insulin therapy, but we do know of both data published with pramlentide in the weight-reducing space and some use as an adjunct to weight management, not illegal use, just use of a licensed compound. Your question on GIP and its potential in the metabolic health space, I think there is much to learn about GIP agonism. We see reports each day on both agonist and antagonist approaches, but clearly GIP through its myriad effects on both beta cell function, islet cell function, potentially on bone health and muscle mass, clearly has, with the dual agonist molecules, shown great promise. Now, what is less well understood is how can this be combined with other classes of therapies, in particular non-increutin therapies, such as petrolentide. So clearly having an effective GIP agonist compound that is safe and well-tolerated, that's what the phase one trial will assess for us that can and likely will be used in multiple combinations this is another molecule as is the history of zealand that we believe can be readily co-formulated and administered with a number of other metabolically active peptides not limited to the ingratin hormones, but as an adjunct to a number of peptide hormone therapies. So right now, this is step one, just as others have developed these standalone molecules that will allow some freedom in formulation and dose selection, as opposed to being tied into a fixed dual agonist molecule. Much more to come in future earnings calls and with data becoming available.

Thank you. We will take our next question. Your next question comes from the line of Rajan Sharma from Goldman Sachs. Please go ahead. Your line is open.

Thanks for taking my questions. I've got a couple. So, firstly, just on the petrolyntide and ecapitide combination, could you just outline your target product profile there? We've also seen some data for Lilly's aloralintide interceptide combination in the EASD abstracts. Is that a level of efficacy that you think is achievable with the Petri combination? And could you maybe just talk about potential other areas of differentiation there? And then second question, just on the royalty agreement that you announced last night, could you just maybe talk about the rationale for the timing that looking at the balance sheet and your previous communication, it doesn't feel like there is an obvious need for capital immediately. So I just wanted to understand what the rationale was for doing that deal and doing it now.

Thank you for your question, Regan. I'll take the first one and hand over the second question to Henriette. On the petrinitide and incipitide combination, I would say there are opportunities to address multiple patient needs with such a combination. And rather than just pursuing the weight loss Olympics, which I think I've been calling a few times that we should stop to care about, we should think about what are the true future patient needs. If you think about a more mature chronic therapy market, most patients will likely start on a monotherapy and then only step into combination therapies if their needs are not solved by a monotherapy. The combination of an amylin and a GIP in our minds looks to be fantastic for those patients who need more. So that could be a patient who started on endosipatide and wanted more and then you add a combination or it could be the other way around as I explained and as many physicians discussed at ADA this year that you start on petrinotide for instance what we think is the most tolerable approach to achieve a weight loss and if you then find out you need more then you step up to a combination between the two products. Where the combination of course looks extremely attractive with the data that are available, broadly speaking, from amidine and GLD-1-DIP combinations is also in patients living with obesity and type 2 diabetes because it seems like we can address both the weight loss and the glycemic deficiencies in a strong way. So I would say when we think about how to develop combination therapies for the future and not the current market, it's extremely important to think about what is the profile needed and not just try to run for the highest number. In particular, not if you then achieve very high dropout rates or a lot of GI side effects when you achieve those numbers. So I think you need to have a more balanced view when you view these data readouts in the future. At least how we think about designing these studies is about what is the future patient needs? What are the profiles of such combination products that could make them highly successful in a future, a more complex treatment world rather than just running after specific numbers. So I hope this addresses partly your question and then I'll hand over to you, Henrietta.

Thanks, Adam. And thanks for the question, Roshan. So you can say this royalty stream, of course, very passive. I think Ruspative as a product and an asset in our pipeline was maybe forgotten a bit by some. This was a good opportunity and we saw a good appetite to actually get this deal done at this time. I think it's an opportunity for us to take this cash and redeploy it into some other activities and opportunities we have in the pipeline. And of course, this was a very passive ownership we had on this product and other strategic assets that doesn't really fit, you can say, our future ambitions and vision. So we will redeploy this cash and put it into future opportunities.

Thank you.

Thank you. We will take our next question. Your next question comes from Suzanne van Vultsen from Van Lanshot Kempen. Please go ahead. Your line is open.

Hi, this is Anna. I'm for Suzanne. Thank you for taking our questions. So could you elaborate on your view on the wider landscape and weight loss with now orals available on the anticipated launches of Ego2Ti at the prototype? How do you expect your treatment paradigm to change with increasingly more options that affect the needs for efficacy and safety and convenience? And where do you believe the opportunity will sit?

Thank you for those questions. I'll start and maybe David will add some color to some of my comments. On the all segment and the GLP-1s, of course, as we are seeing right now, they have opened up the market, and at least according to the manufacturers of these medicines, they are very much getting new patients on board who have not been candidates for their injectable GLP-1s. What we still need to see is, of course, how people manage to stay on these therapies. Will it truly change how we have seen the GLP-1s being used, where we know after three months, we have 30% who have dropped off and after a year only 20% are still on and I really have to remind us all that obesity is a chronic disease and it should be considered a chronic treatment. So this thing that we get on and get off is probably not the way we would address obesity for the future and that's why we are so focused on developing medicines that can give patients the weight loss that the majority of patients are looking for which is a double digit number. If you ask patients, broadly speaking, 80% in our surveys at least suggest that they would be looking for weight loss below 20%. What is important is that we are only, I would say, four to five years into the treatment of what we consider the biggest healthcare challenge of our time, obesity and all the metabolic consequences of living with obesity. So it is a very dynamic market. And as we will see more tools and in particular differentiated tools getting to the market, It will, of course, also be more complex treatment algorithms. One thing where I think we'll see a major shift is that instead of just looking at specific patients and saying this treatment is for that patient or this treatment is for that patient, we'll start to consider treatment of obesity as a weight loss journey. Meaning you start on one product and then you see where you get on that one. And if you don't achieve your goals or if you can't tolerate it, you get on another product. And then you see where that gets you to, or you get on combination products. That's how we treat other chronic diseases. And that's the complexity that we are trying to develop our portfolio for. And this is also coming back to why we are so excited about the profile of petrinotype, because we think it's the logical starting point for most patients, ultimately, when they start a weight loss journey. And then only if they need more weight loss, you will start to consider other more cumbersome modalities or combination therapies. So a more mature market, you should view patients as being on a journey towards achieving their goals and not just as this product fits this patient forever. So it will be more complex. We think we have the pipeline to actually address key aspects of the need of the future.

And it will be exciting. thank you david do you have further yeah yeah adam i'll add a couple of points and i will re-emphasize anna that these are therapies for a lifetime for that weight loss journey that adam described we are still early in this journey and the currently available therapies are really limited to a single incretin-based approach. And much of the clinical development has been in those with what I'll call more substantial or advanced, perhaps end-stage obesity with serious complications like cardiovascular risk, liver disease. The orals are still a minority of the prescriptions as we see the data, weekly injectables are quite readily adopted given both the efficacy. It is that dose escalation, de-escalation, and complexity. To Adam's point, I think historically we have seen in chronic disease that treatment options and their availability with different characteristics, different user profiles don't say for this patient choose X, but actually, as Adam described, allow us to impart upon a weight loss journey in serving those individuals who live with overweight, obesity. I will provide some historical context because I was around and working at a small company, Emelin Pharmaceutical, when Xenotide was launched, and the world looked at us and said, well, we have insulin. Why would we need alternatives to insulin in the diabetes space? And subsequent to that time, GLP-1s were adopted more broadly, DPP-4 inhibitors, SGLT-2 inhibitors. We came to a place where options became really the norm to consider in the management of the chronic disease of type 2 diabetes. In this case, that patient experience, initiating therapy that you can readily or simply dose escalate to an effective dose. And I remind the listeners that even the one and two and a half milligram doses of petrelantide reported in Zupreme 1 had significant near double digit weight loss. So we are not talking about ineffective therapies that in fact, across the board, that tolerability we think can serve an incredibly important need as more and more patients in more and more settings, not just specialty settings, embark upon that weight loss journey. So there will be room to evolve this market over the next five to 10 years, just as we've seen, as Adam mentioned, with other chronic diseases.

Thank you. We will take our next question. Your next question comes from the line of Vandyshe from William Blair. Please go ahead. Your line is open.

Thanks for taking our questions. So at ADA, we heard several investigators discussing the outperformance of placebo arm patients. And I'm just curious if you and Roche have thought about ways to potentially mitigate this kind of recent phenomenon. We also have a second question about 9830, the KV1.3 inhibitor. You mentioned about the potential for a pipeline within a compound, and I'm curious about the upcoming Phase I-B trial. Do you have or will you have any PD biomarkers available for that trial to really support that assertion that we can look forward to?

Thank you for your questions, Andy. I will hand them over to David, both on the placebo responder rates of easy studies, but also on KV1.3.

Thanks, Andy, and thanks, Adam. Placebo response is obviously, I think, something we all think about, but in well-executed trials where you provide additional support to the individuals who participate in your trials, I think it is now quite well understood that in general, a 2% to 3% body weight reduction on average across trials can be expected. I think there are two critically important things that will allow us to better understand that. Remember, placebo-controlled trials are not part of clinical practice, meaning that change from baseline when you are on active drug with the same lifestyle counseling support interventions is really for us and I think for clinicians a key endpoint. Placebo correction is obviously important for regulatory approval. I think two things can shed additional light on that. One is the degree to which you have to support patients who achieve that placebo-associated weight reduction. The second is in trials that have open-label extension, when patients treated with placebo then switch to active drug, how significant is the clinical response? Similarly, longer trials, as is required to have 52 weeks on steady state dosing, also allow you to see the lack of sustainability of many of the placebo treated groups. So I think all of those are taken as one part of the business. We don't want to enroll patients and leave them unsupported in the population that should receive placebo. So that is obviously an important part of the regulatory pathway. The 9830 question as regards the phase 1B approach in psoriasis. Psoriasis has a number of approaches that are both approved and in active investigation. But it is an important, as I'll describe it, sentinel disease where you have skin lesions, plaque size, POSSE scores, et cetera, that can be utilized even over short term to get a glimpse, if not an early indication of the pharmacodynamic response. That said, is this the only pathway down which will go? Absolutely not, as Adam alluded to earlier, having the opportunity to address other inflammatory diseases, other diseases where or disease states where inflammation may play an important role in associated comorbidities such as MASH, such as cardiovascular and peripheral vascular disease. So the pipeline in a product really relates to what we see as the opportunity of the T-cell and T-effector memory cell mediated or driven disease states, the psoriasis study being the first sentinel look at the potential to impact not just markers of inflammation, but clinical measures like plaque size and Posse score.

Thank you.

Thank you. We will take our next question. Your next question comes from Martin Brenno from Nordea. Please go ahead. Your line is open.

Thank you very much for taking my questions. I just have two questions shifting gears a little bit here, but maybe just coming back to your previous commentary about the external opportunities that you have as part of your strategic priorities. Can you maybe just put a few words on how this is tracking? What kind of assets are you primarily looking for and where do you see the biggest gaps in your pipeline that you might not be able to close organically? And second to that, on the early pipeline, can you just help me understand what your top priority is? We will get multiple phase one, phase two initiations. Can you just elaborate a little bit on that? And should we expect inflammation as a category to become a strategic indication for CNN Pharma on the medium term here? would be my question. And then just final question, sorry for the many questions here. But when we look at all the therapies, I get the commentary that it's not a great part of the overall category today, but with the trajectory we're seeing, that most likely will have a pretty decent size of the total market over the medium term. So just wondering how you see Ceylon Pharma tapping into that opportunity. Thank you for taking my questions.

Thank you for your questions. And if I'll just start with number one, the strategic priorities, when we think about external opportunities, I think you should really think a little bit along what we also announced last year in December with OTR, where it's a collaboration with more of a platform company who can help us tap into modalities where we are not as established ourselves yet. So this was a small molecule drug discovery collaboration where we then apply our strong metabolic know-how and then take the products, of course, forward. So similarly, when we are looking into the focus for our external opportunities right now are in the early stages as we expand the modalities that we are going to work on beyond peptides. So that is the clear focus right now. As you can see, we are quite busy in the clinical part of the pipeline. And how we think about developing the pipeline, it's really that overarching theme of metabolic health. So beyond obesity, of course, beyond weight loss, but really how do we help people have a longer health span, not just a lifespan, but living healthy longer. And a component, as David also alluded to, of course, a strong component within that metabolic disturbances we see associated with obesity and the metabolic challenge situation that many find themselves in today is, of course, inflammation. So you could see inflammatory targets being part of sealants innovation, but when it's more specifically towards specific indications that are, you know, autoimmune diseases that are established, that's where you should expect us to, at one point before we get to the market, have partnerships in place. So we have dedicated companies to work on those pathways. KV1.3 is a good example because it's a pipeline in a product. Of course, there will be certain areas where we would not take the lead ourselves ultimately, but have a partner doing so. So that would be the strategy for that. On the oral therapies, we do see a significant opportunity with oral therapies, in particular once we move beyond the GLP-1s, because an oral GLP-1 doesn't address the biggest issue with the GLP-1s, which is the side effects that many people fail to tolerate them. But of course, as we think about this market in 10, 15, 20 years from now, we also expect oils to play an increasingly important part. And that's one good example is why we engaged in a partnership with OTR. We have other opportunities. So we are really thinking about the future. But if you think about it, an injectable, convenient injection once a week is actually, as we have seen with the success, not only in obesity, but also in diabetes with the DL1, despite their quite cumbersome use, a quite attractive profile. Thank you. Thank you.

Thank you. We will take our next question. Your next question comes from Kerry Holford from Berenboe. Please go ahead.

Your line is open. oh thank you for taking my questions um petrol in tide mono just in terms of timing adam you stated it was now full speed ahead in your intro and i think we'd all agree speed to market is important uh just intrigued to hear the latest on this because obviously we saw the headline phase two back in march we don't see any phase three trials yet listed on clinicaltrials.gov but we do see the details for the phase two combo which is scheduled to start in September so is it fair to assume that phase three mono will start after phase two and what else are you now waiting on in conjunction with Welsh to to move into and actually start the phase three mono question from a financial point of view also following that royalty farmer agreement interested to hear whether you're looking at any other royalty agreements that you may have internally, which could be capitalized and redeployed in this way. And then if I can squeeze a final one in on Servidu Tide, the body composition data are clearly interesting, but of course the debate ADA was on tolerability. To your earlier point, are you able to tell us whether any of the new phase 3s that are planned will allow for slower dose titration to improve the AE profile and discontinuation rate.

Thank you for your question. So I'll take the first and the last and then hand over the middle question to you, Henriette. On timing of petroleum-type mono, I can assure you it's full speed ahead, and I cannot comment on if it's before or after. We'll start the COMPO study, but I can assure you that it's full speed ahead, as both us and we understand the importance of getting to market as early as possible with this potentially very important first choice medicine. On servitotide, I think it's fair to expect that the titration scheme has been changed for the new phase 3b studies that have been the four studies that have been initiated this year. Also, because Boehringer have already been outstating that for the leverage program, So the program targeting MASH, they have actually a different titration scheme. And you also heard, if you participated at the ADA, that the presenters there described that it does lead to a different experience on these drugs and this at least perceived side effects. That was what we heard at least. So, yes, we would assume the titration to be more reflecting what is being used in liverage. And there they have indicated that the titration is different. and really, again, highlighting that Beringer have initiated a phase 3b study to inform how to dose this product in the real world. So our clear assumption is that it will have a tolerability profile which is comparable to the other DLB ones once you allow more flexibility in the dosing. And that's why we are so excited. At least we also see Beringer's excitement around the program. Enoyele?

Thanks, Adam. So, of course, what we do always is to look at our balance sheet and see how we optimize and also how we deploy capital. And you can say this was an example of active, you could say, capital allocation. Of course, all our assets and all our agreements are listed in our annual report, so it should not be a surprise. But as always, as you know, we look for opportunities both to get cash in and cash out at the right time. And this, I think, was a good example of that.

Thank you. We will take our next question. Your next question comes from the line of Mathis Gries. Danil from KBC Securities. Please go ahead. Your line is open.

Hi, thanks for taking my question. I had one question on the KV13 inhibitor. Could it also be co-formulated with your other peptide drugs in obesity-related indications? Thanks. Thank you. That's a very interesting question, and it's definitely something we'll be looking into because the combination of both addressing metabolic disturbances and the underlying inflammatory components of metabolic diseases is highly interesting.

So good question, and we'll probably address it in more details at future calls and conferences.

Hi, Heidi. We'll take one more question.

Thank you. Please stand by. Your final question comes from the line of Pracar Agua from Accanto. Please go ahead. Your line is open.

Hi. Thank you so much for taking my questions, and congrats on all the progress. Uh, maybe firstly, uh, on Supreme too, if, if, um, Adam and David, if you can set expectations for Supreme too, on weight loss, HP1C and safety tolerability, given what we saw in Supreme one and anything on the baseline example, men versus women split, uh, that we should be aware for Supreme too. Uh, that's my first question. Uh, second question on the, uh, Petri plus Roche's GLP1 GIP agonist combo, um, one clarification, if you can elaborate on the form factor is this a single chamber device or something else and then last question maybe just broadly on the KV 1 1.3 of channel walker and psoriasis given what we are seeing with some of the oils in this space and psoriasis where do you think this MOA can differentiate especially with any context of oral take-toes and oral al-23 that are showing biologic like efficacy anything that you think that KV 1.3 could do better. Thank you so much.

Thank you, Bakay. I'll just answer your questions on Supreme 2. I would say it's a shorter study. Remember that. It will read out here in the second half. We will be looking to see, of course, both weight loss, but also placemic control and other parameters, how they read out. One of the key features of amylin in general, and that's, of course, also why we're excited about this program, is that it looks like amylin is as effective in driving weight loss in obese individuals living with type 2 diabetes as it is in those who do not have type 2 diabetes. So that's some of the aspects we will be looking for in this study. And of course, also understanding better how betranetide affects the glycemic situation for these patients. But again, I have to remind you that this study is not informing our phase 3 initiation, but it's a study we very much look forward to see the results and really also if we We can expect to see similar weight loss in patients with type 2 diabetes as in those who do not have diabetes. Remember, with the other ones, often you see around 30% less effect for weight loss in patients with type 2 diabetes. On the combination of the two products, I actually forgot what you asked about, but on KV1.3, sorry, but let me just answer on KV1.3. first on psoriasis. This is a small phase 1 B2A study to look for PD markers in a disease state. And psoriasis is only one potential indication we are pursuing. You should expect us to pursue multiple indications in parallel as we mature this program, if it's successful here in the early stages. Could you just repeat your second question?

It's on the form factor and the device.

Is it like a I think David mentioned this in his prepared remarks that we are applying two different cartridges in this study in order to inform the single cartridge use in the anticipated phase 3 program where it should be a single container.

Thank you so much.

Thank you. This concludes today's question and answer session. I'll now hand back to Adam Steensberg for closing remarks.

Thank you for attending and for all your questions today. We look forward to future announcements and updates and to connecting in the coming weeks and months. Thank you.