Good day, and thank you for standing by. Welcome to the Zealand Pharma Results for Q1 2025 conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during this session, you will need to press star 1, 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1, 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Adam Langer, Vice President, Investor Relations. Please go ahead.
Thank you, Operator, and thank you to everyone for joining us today to discuss Zealand Pharma's results for the first three months of 2025. You can find the related company announcement on our website at zealandpharma.com. As described on slide two, I caution listeners that during this call, we will be making forward-looking statements that are subject to risks and uncertainties. Turning to slide three and the agenda. With me today are the following members of Zealand Pharma's management team: Adam Steensberg, President and Chief Executive Officer; Henriette Wennicke, Chief Financial Officer; and David Kendall, Chief Medical Officer. All speakers will be available for the Q&A session along with Eric Cox, Chief Commercial Officer. Moving to slide four, I will turn the call over to Adam Steensberg, President and CEO.
Thank you, Adam, and thanks to everyone for joining today. Zealand has never been in a stronger position than we are today, financially, organizationally, and in terms of our clinical development pipeline. Our vision is to become a key player in the future management of obesity, and we now have the strongest possible foundation to realize this vision. We have a differentiated mid-to-late-stage obesity pipeline and recently entered a historic and transformative collaboration with Roche on petrelintide. The agreement with Roche includes co-development and co-commercialization rights, a 50/50 profit sharing in the U.S. and Europe, and adds a new product candidate to our pipeline in the form of petrelintide CT388. We look very much forward to embarking on this partnership with Roche, aiming to establish the leading amylin franchise with petrelintide as a future foundational therapy for weight management.
Both of our late-stage rare disease programs have a clear path forward. We remain committed to bringing these programs to patients as quickly as possible while actively exploring partnership opportunities. During the last two years, we have significantly strengthened the organization to prepare ourselves for this unique next phase of accelerated growth, and importantly, we have secured enough capital to fund our journey towards profitability. In the last period, we have seen geopolitical and market uncertainty. In general, I believe Zealand Pharma is in a strong position to meet these challenges as we expand our operations and invest for accelerated growth. Our strong capital situation allows us to progress towards profitability with confidence, and our execution power has been significantly improved both due to the strengthening of our organization and due to the Roche partnership for petrelintide, where they are responsible for setting up commercial manufacturing and supply.
We believe that amylin analogs hold the potential to become the future leading category for weight management. The increasing body of clinical evidence supporting the safety, tolerability, and efficacy of amylin analogs has de-risked the amylin, the protein site program as well. In fact, there has been a short-acting amylin analog on the market approved for diabetes for more than 20 years, and in December last year, we saw phase three data with another long-acting amylin analog that appeared to have a safe and well-tolerated profile, further de-risking the class. Thus, in petrelintide, we are based on the clinical data reported to date and due to the molecular-specific attributes, confident in our best-in-class potential and thus a unique opportunity to build the leading amylin-based franchise for weight management.
Turning to slide five, we have a strong focus on building the foundation for the next phase of accelerated growth for Zealand. Fueled by the partnership with Roche, we can now increase our efforts on several fronts, including significant new investments in the research pipeline targeting obesity and inflammation. Due to the type of partnership agreement that we have entered with Roche for petrelintide, retaining equal strategic rights and 50/50 profit sharing in the US and Europe, Zealand has the potential to become a very different company in just a few years, and we need to have a pipeline that reflects such a company. In recent months, we have strengthened the organization across all layers. Steven Smith, a recognized leader in obesity and metabolism clinical research, has joined us as Medical Advisor in obesity.
Steven will be central in advancing our obesity research and clinical development programs in our pursuit of addressing one of the biggest healthcare challenges of our time. In April, we were excited to welcome Utpal Singh as our Chief Scientific Officer and new member of the executive team at Zealand Pharma. Utpal brings nearly 25 years of industry experience spanning the full drug discovery and development lifecycle, most recently as Senior Vice President of Small Molecule Discovery at Lilly, where he spent more than 18 years. Utpal will lead the discovery and clinical translation of peptide medicines, leveraging technologies including data science and AI to enhance our discovery process. Hence, Utpal will drive the next wave of differentiated innovative therapies at Zealand Pharma and will be instrumental in building the company into an enduring and generational biotech. This leads me to slide six.
We are focused on developing new and better treatment options for people with overweight and obesity to tackle one of the greatest healthcare challenges of our time. We are still in the very early days of the evolution of this market. In the US, only about 2% of eligible patients with overweight and obesity are on pharmacotherapy today. Despite the availability of once-weekly GLP-1-based therapies, real-world treatment persistence remains a challenge, and the number of patients benefiting long-term from these treatments has not yet seen a substantial improvement. There is thus a significant unmet medical need for therapies that can deliver effective weight loss, but with an improved tolerability and acceptability compared to current therapies on the market, including a lower frequency and milder severity of gastrointestinal adverse events so that patients may have a more positive experience and can better achieve, and importantly, maintain a healthy weight loss.
In a weight loss maintenance setting, we believe that gastrointestinal adverse events like diarrhea, constipation, and this feeling of having lost your appetite experienced by many patients on a GLP-1-based therapy are just as important as the more commonly discussed nausea and vomiting. While all GLP-1s and once-monthly injectable GLP-1s may help expand the overall GLP-1 class, we view them more as complementary approaches rather than distinct alternatives. With the potential for an improved gastrointestinal tolerability profile and differentiated mechanism of action that makes people feel full faster rather than suppressing their appetite, we believe that amylin analogs can be the preferred choice for the vast majority of people with overweight and obesity, both during weight loss and, importantly, in the weight loss maintenance setting.
With that, let's move to slide seven as I turn over the call to our Chief Medical Officer, David Kendall, to discuss our R&D pipeline.
David.
Thank you, Adam. Today, I would like to focus my remarks on the continued advancement of our obesity programs, in particular, petrelintide, following the announcement of our exciting partnership with Roche. I will also provide a brief update on our other ongoing development and regulatory activities. Let's move to slide eight. We now have the opportunity, together with our partner Roche, to establish the leading amylin-based franchise for weight management and rapidly expand into obesity-related comorbidities. We remain committed to advancing petrelintide as standalone therapy targeting 15-20% weight loss and better patient experience with improved gastrointestinal and overall tolerability and acceptability. We believe such a product profile has the potential to address the unmet medical needs for the majority of people living with overweight and obesity, thus positioning petrelintide as a foundational therapy.
We also maintain that petrelintide has the potential as a best-in-class therapy as this asset is both physically and chemically stable with no fibrillation at physiologic pH, and petrelintide was developed so that it can be co-administered and co-formulated with other peptide-based therapies. The broad collaboration scope with Roche allows us to explore and unlock the full potential of petrelintide and reach as many patients with overweight and obesity as possible. Together, we will leverage the advantageous attributes of petrelintide and explore the candidate in combination with other agents, starting with a fixed-dose combination product of petrelintide and CT388, a potential best-in-class GLP-1 GIP receptor dual agonist and Roche's lead incretin asset.
One novel concept that we find interesting with the petrelintide CT388 fixed-dose combination product is to maximize the dose of the generally better tolerated non-incretin agent petrelintide, adding the optimized dose of the incretin-based GLP-1 GIP therapy for people who both need and desire more weight loss and/or improved glycemic control without materially compromising tolerability. Together with Roche, we look forward to initiating phase two trials with the petrelintide CT388 fixed-dose combination product in early 2026 and to explore other potential petrelintide-based combination products as we move forward. Turning to slide nine for an update on the status of petrelintide phase two Zupreme program. In December 2024, we initiated a large and comprehensive phase two trial with petrelintide in people with overweight or obesity.
Zupreme one is a dose-finding trial assessing the safety and efficacy of five doses of petrelintide versus placebo over 42 weeks of treatment. We were also excited to announce the completion of enrollment for this trial in March 2025, just three months after trial initiation, and we look very much forward to reporting top-line results from Zupreme one in the first half of 2026. In April 2025, we also announced the initiation of Zupreme two, a phase two trial of petrelintide in persons with overweight or obesity and coexisting type 2 diabetes. In this population, data suggest that amylin agonism may potentially deliver weight loss comparable with that observed in the non-diabetes population. Another potentially important differentiation opportunity with amylin agonists as compared to GLP-1-based therapies, where attenuation of weight loss has been consistently observed when comparing those with diabetes to those without diabetes.
We expect to complete the Zupreme 2 trial in the first half of 2026. The clinical development of petrelintide is progressing very well, and together with Roche, we are excited to leverage insights from the Zupreme program to guide the design of a comprehensive and ambitious phase 3 registrational program for petrelintide in weight management. Turning to slide 10 for some remarks on survodutide and dapiglutide. Survodutide, a dual glucagon GLP-1 receptor agonist, is in late-stage development for both obesity and metabolic dysfunction-associated steatohepatitis or MASH. In the first quarter of 2025, Boehringer Ingelheim completed enrollment in the phase 3 SYNCHRONIZE cardiovascular outcomes trial, marking full enrollment in all trials in the phase 3 obesity program. We look forward to top-line data from the first phase 3 trial in people with overweight or obesity anticipated in the first half of 2026.
Boehringer Ingelheim expects to launch survodutide in 2027 or 2028, and if successful, survodutide could be the third incretin-based therapy to market, and it would be the first approved dual glucagon GLP-1 receptor agonist in this exciting era of novel weight loss therapies. Survodutide holds best-in-class potential for the treatment of obesity and MASH. We are very excited about the ongoing phase three program in people with MASH, which represents the largest ever Phase Three MASH program with an incretin-based therapy and the only program to also include people with compensated cirrhosis. MASH is one of the most prevalent and serious obesity-related comorbidities with significant unmet medical needs. It is estimated that one-third of people with overweight and obesity have MASH.
With best-in-class MASH data presented last year from a 48-week phase two trial, we believe survodutide has the potential to become the preferred therapy in a very large and growing market, benefiting patients who urgently need more and better treatment options. Dapiglutide is designed as a potent GLP-1 receptor agonist targeting significant weight reduction and offers the potential to also leverage GLP-2 pharmacology to improve gut barrier function and address the low-grade inflammation associated with metabolic disease. We look forward to presenting the results from part one of the phase one B dose titration trial with dapiglutide at the American Diabetes Association's 85th scientific sessions in June 2025. In the second quarter of 2025, we also look forward to reporting top-line results from part two of the phase one B trial investigating higher doses of dapiglutide over 28 weeks of treatment with subsequent initiation of a phase two trial.
Moving to slide 11 and a brief update on our rare disease programs. For dasiglucagon in congenital hyperinsulinism, resubmission of part one of our original new drug application and the subsequent submission of part two are contingent on an inspection classification upgrade of our third-party manufacturer's facility. While we await the potential classification upgrade, we are implementing a supply contingency plan in parallel, including qualification of an alternative supplier to ensure that we can bring this product to patients in need as quickly as possible. For glopaglutide, for the treatment of short bowel syndrome with intestinal failure, we successfully completed the type A meeting with the U.S. FDA in March 2025.
We have now ensured alignment on the trial design of the phase three EASE-5 trial so that it can support regulatory submission in the U.S., and we remain on track to initiate EASE-5 in the second half of 2025, and we expect to share more details on the trial design later this year. We also still anticipate submitting a marketing authorization application in the second half of 2025 to support the approval of glopaglutide in the EU. With that, I would now like to turn the call over to our Chief Financial Officer, Henriette Wennicke, to review our financial results for the first quarter of 2025. Henriette?
Thanks, David, and hello, everyone. Let's turn to slide 12 and the income statement. Revenue in the first three months of 2025 was DKK 8 million, mainly driven by the license and development agreement for dasiglucagon with Novo Nordisk. Revenue from the initial upfront payment of $1.4 billion related to the collaboration and license agreement with Roche will be accounted for upon closing of the agreement, which we expect in the second quarter of 2025. Research and development expenses of DKK 290 million are mainly driven by the development of petrelintide, including the last phase two Zupreme one trial and preparation for the phase two Zupreme two trial, which was initiated in April 2025. Sales and marketing expenses of DKK 37 million are mainly driven by pre-commercial activities associated with our rare disease assets.
General and admin expenses of DKK 65 million reflect the continued strengthening of organizational capabilities as we prepare the organization for the Roche partnership, as well as investment in IT infrastructure and our patent portfolio. Net financial items of DKK 70 million are mainly driven by interest income from the excess liquidity invested in market-held securities. Let's move to slide 13 and the cash position. As of March 31, 2025, cash equivalent and marketable securities total DKK 8.5 billion. As mentioned, we expect to receive the $1.4 billion upfront payment from Roche in the second quarter of 2025, equal to approximately DKK 9.2 billion. Upon closing of the transaction, this will bring our cash position to roughly DKK 18 billion. I can confidently say that we are in an extremely solid financial position.
On top of this, we will receive in total $250 million in anniversary payments over two years and potential development milestones of up to $1.2 billion, with the vast majority of these development milestones linked to initiation of phase three trials with petrelintide monotherapy. I'm not only confident that we can fully meet all our financial obligations under the Roche partnership for petrelintide, but also that our solid financial position provides ample flexibility to invest beyond petrelintide, including in our early-stage research pipeline targeting obesity and inflammation, and to further strengthen our organizational capabilities in preparation for the growth journey ahead. Based on our current clinical and organizational plans, we project that we have the financial strength to take Zealand Pharma all the way to profitability with no need to raise additional capital. This is truly a pivotal milestone for the company.
Turning to slide 14 and the financial guidance, I will keep this short as there are no changes to the outlook for the year compared to what we outlined in February 2025. We confirmed the financial guidance on net operating expenses, which we are expected to be between DKK 2 billion-DKK 2.5 billion, excluding transaction-related costs associated with the Roche partnership agreement. We expect these transaction-related costs to be approximately DKK 200 million in 2025. With that, I will move to slide 15 and turn the call back to Adam for concluding remarks.
Thank you, Henriette. The first quarter of 2025 was truly historic for Zealand Pharma, but I'm even more excited about what's to come. Some of the key catalysts over the next 12 months are highlighted on this slide. First and foremost, we look forward to initiating our collaboration with Roche once the agreement is closed, which is expected here in the second quarter. Regarding clinical data, we will report additional results from the phase 1b trial with dapiglutide later this quarter, and in the first half of 2026, I'm particularly excited about the phase 2 top-line results with petrelintide and top-line results for the phase 3 obesity trials with survodutide. Moving to slide 16, as a final note, I encourage all of you to save the date for Zealand Pharma's Capital Markets Day on December 11, 2025, in London.
The event will feature speakers of our management team as well as thought leaders in obesity. We will speak in more details about this day later in the year and hope to see many of you there, either in person or online. Thank you all. I will now turn over the call to the operator for questions.
Thank you. As a reminder, to ask a question, you will need to press star 1, 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1, 1 again. We will take our first question, and your first question comes from the line of Michael Novod from Nordea. Please go ahead. Your line is open.
Thank you very much, Michael Novak from Nordea. Two questions, one to petrelintide and one to dapiglutide. On petrelintide, maybe can you try to elaborate more on at least the early discussions you had with Roche when you did sort of the deal? I know you can't really talk together right now until the deal is closed, but the early discussions around different ratios for the amylin versus GLP-1 in order to try to improve tolerability, also with focus on how the initial data looked for CT388. Secondly, for glopaglutide, and I know it's already just out of the gates from one big collaboration, but maybe you can try to talk about how you try to plan for outlicensing of glopaglutide.
Will we see you already in the second half of this year trying to sort of close a deal on glopaglutide, or do we have to wait until potential launch in Europe or that you are progressing further towards the market in the U.S.? Thanks.
Thank you, Michael. I will hand over the first question to David, and then the second question to Eric to talk about our efforts on GLP-1 partnering. David, will you take the first question, please?
Happy to, and Michael, thanks for the question. I think while these are early days, and to your point, we will only fully engage with our Roche partner on detailed discussions once the clearance period is completed. In those discussions and in sharing some detail around the data you and others have seen from their public disclosure of the CT388 program, there is significant effect at relatively lower milligram doses with CT388. I believe the 8 milligram dose performed quite well. Of course, the very rapid titration scheme that was used in their early-phase program has not given full clarity around how one can optimize tolerability of that incretin-based therapy.
As we said in the prepared remarks, I think our goal, once we see phase two data from both Zupreme one, as well as the first of the CT388 programs, we will have a much better sense of where tolerability can be optimized and formulation can be optimized to do, as I described in my remarks, maximizing petrelintide and optimizing the 388 program. To predict on a milligram basis at this point prior to phase two data being available would be premature. Given both what we know about each asset, what we have learned from the CagriSema program, we think we can certainly maximize the weight-reducing capacity and further optimize that tolerability and acceptability profile. More to follow, Michael. Eric, over to you.
Thank you, David. Michael, thanks for the question. I think with regard to the GLP-1 partnering, I think there's been a lot of interest even prior to the APRA announcement. I think we're very encouraged by the dialogue we're having. We'll still see that begin to progress. I don't think we have a clear timeline on exactly when things will be moving forward, but there is quite a bit of interest here, which I think is very encouraging as we move forward. I think just hold tight, and we'll better see where we move with this. We are very encouraged with the conversations we've had, and they've been very productive at this point.
Okay. Great. Thank you very much.
Thank you. We will take our next question. Your next question comes from the line of Andy Shea from William Blair. Please go ahead. Your line is open.
Great. Thanks for taking our question. Adam, I think you mentioned briefly in your prepared remarks about this topic, but I'm curious about the team's take on the maintenance opportunity. Specifically, how do you envision designing studies to answer relevant clinical questions? Do you plan to do this in a phase two setting, or based on available PK data, it could be seamlessly incorporated in the phase three program?
Okay. Thanks for your question. I will start by providing some more thoughts here, and maybe David will add some flavors. In general, I think if you look into the space so far, most companies have actually focused on weight loss. In order to achieve health, which is why we are here, you need to make sure that patients stay on therapy. We think what we are seeing right now, once you let the current medicines in the hands of patients and they are in a real-world setting, many patients struggle to stay on therapy. As we mentioned before, our understanding is that it is mostly not due to the common, you can say, known side effects to the GLP-1s of nausea and vomiting.
Many patients, once they have achieved their weight loss and get into the weight maintenance phase, it's actually side effects such as diarrhea, constipation, and this thing that you lose your appetite that is a problem. I think the other thing that is a problem is that if you are too aggressive with how much you push your weight loss, let's say a very ambitious patient achieving 30% weight loss, that person may struggle to maintain such a dramatic weight loss because most people actually, once they get further into life, also would like to engage in social gatherings around food. Many patients simply feel they have to change their life too much if they have these dramatic weight losses.
This is why we are super excited about petrelintide, because we think it has a more benign profile towards GI tolerability, and most importantly, maybe because it works on appetite basis, where it makes you feel full faster. It will basically not reduce your appetite, but just make you feel full faster. The other thing that the industry has failed a little bit is to explore, and I think that is what your question alluded to, how to dose these drugs in the maintenance phase. This is something that we, of course, anticipate that we will discuss further with Roche, how to address that, because as I said before, we think it's actually the most important phase to focus on. How do we make sure that we optimize both for the weight loss, but also for weight maintenance with a drug like petrelintide?
It is clearly something that we expect to discuss further with Roche once we get the collaboration going. David, do you want to add some more to that?
Yeah, just a couple of points, and thank you, Andi. I agree and aligned with Adam that I think looking at the opportunity to both design and execute what I'll call clinically practical clinical utility studies, how will people utilize petrelintide and/or its combination in real life, not solely this arms race to a bigger number over a relatively short period of time. I think we have learned quite clearly that these will not be drug withdrawal studies other than perhaps a switch from one class of agent to another, for example, coming off an incretin-based therapy to an amylin-based therapy, if that's a patient's desire or is of clinical interest. I think in addition to what Adam has provided, there are characteristics of amylin agonists, some of which we've learned from pramlintide in its history.
First is that satiety signal rather than this anhedonic food aversion signal, as Adam alluded to. That is not appealing to a lot of people, meaning avoiding food, whereas having the opportunity to maintain some degree of appetite but feeling full fast is important. Remember too, there are mechanisms that we only partially understand, and that's the leptin sensitization. If you can maintain sensitivity to the signal that comes from adipose tissue, namely leptin, will that allow you to continue to maintain a higher quality weight loss, not just a greater degree of weight loss? All of these will be parts of what I hope we can assess in these later clinical usefulness, clinical application studies.
Thanks. Thanks, Andi.
Thanks, Andi.
Thank you. We will take our next question. Your next question comes from the line of Prakhar Agrawal from Cantor Fitzgerald. Please go ahead. Your line is open.
Hi. Thank you for taking my questions and congrats on all the progress. I had two on Zupreme 2 in overweight obesity with type 2 diabetes. Number one, what will be the top doses tested in Zupreme 2? Would it be similar to Zupreme 1 in obesity without type 2 diabetes? Second question, early data suggested weight loss benefit for amylin in type 2 diabetes should track closer to obesity, but we did not really see that materializing with CagriSema redefined 2 trial. I am wondering if the team had any thoughts here as it relates to the amylin plus GLP-1 combination, and would you still expect amylin monotherapy to have similar weight loss in type 2 diabetes and obesity? Thank you.
Thanks for your question. I will just provide a few notes and then hand it over to David. We are kind of limited by the top dose that we are also exploring in the Zupreme 1, so it will be the similar top dose we explore in Zupreme 2. As David said at his call, we clearly believe that amylin analogs have the potential to provide similar weight loss in patients with type 2 diabetes as in patients without type 2 diabetes. I think if you carefully look into the CagriSema data and compare that to what was achieved with Sema as a monotherapy, it was actually a very significant additional weight loss that Novo observed in a type 2 obese population, probably close to doubling the weight loss.
We think that is a very strong achievement, especially because we do not think that you can say in that molecule, you can say the amylin component has been utilized to its fullest extent. We think it is a low dose of amylin compared to what we progress with. We have a lot of confidence still in this patient group. David, any further comments?
Yeah, I'll just reemphasize, Adam, what you said. That, Prakhar, is that in the CagriSema program, at least our perspective is that once again, if you can maximize the exposure to an amylin agonist and you don't have a profound need for the potent glucose-lowering component of incretin-based therapy, you can either remove or certainly minimize the exposure to the incretin-based therapy. To Adam's point, I don't think we saw the full potential of the amylin agonist in that program. Obviously, Zupreme 2 is a standalone amylin agonist only, where we anticipate that the data will tell us that comparable level of weight reduction. Certainly, both data historically from the pramlintide studies and more recently the phase two data with petrelintide in the type 2 diabetes phase two study support this hypothesis.
Of course, that's why we execute the trials, and I think we will better understand both the dose response, which, as Adam said, are similar doses at the top end, and the capacity to maintain weight loss potential with an amylin agonist alone.
Thank you.
Thank you.
Thank you. We will take our next question. Your next question comes from the line of Suzanne van de Vroomen from Van Lanschot Kempen. Please go ahead. Your line is open.
Hello, team. Thanks a lot for taking my question. This is Chiara Montironi on behalf of Suzanne van de Vroomen. I was wondering, for the petrelintide phase 2b readouts next year, what should we expect a top-line release to include, and what would you consider a good result? I was also wondering whether these phase 2 studies will include measurements of body composition or any biomarkers that may feed into the potential of amylin for better quality of fat versus lean mass loss. Thank you.
Thanks. I'll just start and then hand over to David as well. We do include measurements of body composition using MRI. Good result. It's actually, I would say, probably too early to comment on that one. What we are aiming for is ultimately in phase three to have a product that demonstrates 15%-20% weight loss. Of course, the readout here only goes up to 48 weeks, and we will continue for phase three studies for longer. It's not only the number, it's also, of course, the slope of the curves at that time that defines what a good outcome is. As long as we are confident that we can achieve that profile, we would be more than happy.
As we have also alluded to several times on this call, very important is to understand the tolerability profile, which we think will be the key driver of differentiation compared to the GLP-1s. David, any further?
Yeah, two comments in addition, Adam. The first related to MR, which I think is an important measure of body comp, remembering that this allows us to look specifically at fat mass, not just lean versus non-lean mass. A bit more discrimination, which I think will help us better understand what is translated from the data that have been observed in non-clinical models. The second, as Adam alluded to, is not just the slope of the line, but are we seeing clear separation of doses so that we can approach the regulatory authorities at the end of phase two and say, "We have clear designs on specific doses for phase three execution." I think it is important to remember that given that tolerability is one of the things that we believe will allow us to differentiate petrelintide, the titration scheme is monthly.
Again, as in my response to Prakhar, this is not a race to the greatest number, but rather an understanding of can we support the tolerability and acceptability profile and still see a trajectory that, as Adam alluded to, takes us to the 15%-20% GLP-1 monotherapy-like weight loss. In general terms, those are the things we will be looking at at the end of phase two and with those top-line results.
Thank you very much.
Thank you.
Thank you. We will take our next question. Your next question comes from the line of Charlie Hayward from Bank of America. Please go ahead. Your line is open.
Thank you for taking my questions. The first one is, your peer talked yesterday to still seeing an average stay time on the GLP-1 of around seven months. I appreciate some of that is supply and payer-driven. Where do you think, or what's your vision for where you could get to for petrelintide monotherapy stay time in the future, especially in the context of maintenance therapy? Secondly, on your comment about needing a pipeline to reflect the future company, and you're sort of saying petrelintide program is obviously fairly de-risked, and acknowledging that your GIP agonist has not moved for a while, could you talk about your ambition for future R&D in this sort of cardiometabolic space beyond the current portfolio? Any targets you see particularly interesting? Any unmet needs you expect to evolve? Thank you.
Thanks for your question. Yeah, and we agree to the observations around the average stay time for the GLP-1s, around seven months. I think it's really important when you discuss that seven months that you also appreciate that it's in a therapy area where there are not many other choices. While you can say it may be quite similar to what we see in other chronic therapy areas, the fact is it's not because people get on other brands or other modalities. It's because they stop treatment, which is super negative because ultimately you only achieve health outcomes if you achieve weight loss and maintain that weight loss. There's a huge task ahead for the industry to make sure we develop weight loss agents that can help people not only lose weight, but also help them maintain those weight losses.
Therefore, we, of course, have a much higher ambition for how long patients should stay on an amylin. We really think because we have been so excited about seeing now the first medical tools that can help people lose weight, I think somehow in that conversation, we forgot about the patients. We forgot about we are just humans who want to live a normal life, a little bit healthier life. Many patients, once they have achieved the weight loss, are not ready to make the commitment of carrying the burden of diarrhea, constipation, and that thing that you have lost your appetite. We think it will create a significant new opportunity with petrelintide if we can continue to provide the results we have seen thus far.
Of course, if you think about the market opportunity, if you can maintain patients on treatment for longer, that really is something that drives up volumes instead of having to go out and capture new patients constantly, as we see right now is the case for the current launches. We are, you can say, very positive on the opportunity to help patients stay on longer with a category like amylin, in particular with petrelintide. On the future pipeline, it's too early for me to comment on it, except that we will increase our investments big time. You can say December 11, that's probably where you will get the full vision for how we think about driving the pipeline forward.
Of course, it's also already today obvious from our pipeline chart that we have opportunities within the chronic inflammation immunology with the KB1.3 as an example, which is right now in phase one, which holds potential really to, you can say, become a pipeline within a program. You should expect to hear more in December, maybe also a little earlier, but have the full picture at our capital markets day in December. Thanks for the question.
Thank you.
Thank you. We will take our next question. Your next question comes from the line of Sean Hennessy from Jefferies. Please go ahead. Your line is open.
Hi. Thanks for taking my questions. There are two for me, please. How will you define success in the phase two dapiglutide study that you expect to initiate during the second half of the year? Although I appreciate it's still quite far away, could you give us some initial thoughts on the potential topics for the Capital Markets Day in December? Thank you very much.
Thanks. I think success for us with that, that is we are aiming for, you can say, a confirmation that we can achieve GLP-1-like weight loss with this program once we have explored the full dosing potential over 28 weeks. As David also alluded to, and maybe David, do you want to provide more comments? It's really the opportunity to differentiate in how well we address inflammation, which gives us high confidence in this program. Because honestly speaking, we don't think the world needs that many more GLP-1s unless they are compared to what we already have in late clinical development out there, unless they're truly differentiated on parameters that go beyond just weight loss. I think it's time we move beyond that weight loss number and think about what is the true value you bring to patients with these novel opportunities.
On the Capital Markets Day, there's no question that a lot of the theme will be around the obesity, how we see the market develop, how we see our product opportunities fitting into that space. Having key opinion leaders also talking, you can say, around some of the dynamics in the biology. We will share more light around where we expect the early pipeline to develop in the coming years. It will be hopefully a very content-rich day, which also provides a very clear direction for our ambition in the coming years. David, do you want to provide further to the deputy?
Yeah, I will add, Adam, to your comment. I think, as is noted, there will be myriad GLP-1-based therapies, and the differentiation is key. We have a number of non-clinical efforts ongoing to look at the biologic plausibility of addressing neuroinflammation, hepatic inflammation, vascular inflammation, generalized inflammation. Defining success beyond the weight-reducing capacity of DAPI will be finding those comorbidities or disease state targets where we believe DAPI can shine or outshine other incretin-based therapies. You could say it's threading a needle, but more importantly, it is, in our mind, finding those areas where either persistent or continued inflammation drives the disease process beyond weight management alone. We believe, as I alluded to, that that could be vascular inflammation, could be hepatic inflammation, could be neuroinflammation.
Success will start with the weight-reducing effects and then finding those specific areas where we think dapiglutide can shine most.
Thanks for that.
Thank you. Once again, if you wish to ask a question, please press star one, one on your telephone. We will take our next question. Your next question comes from the line of Oliver Burrow from Goldman Sachs. Please go ahead. Your line is open.
Hello. It's Oliver Burrow on for Goldman Sachs . Two questions. Firstly, on the amylin competitive landscape. We've seen some early data from AbbVie or Gubra's Gubamy, and there's some upcoming data from Lilly's Aloralentide ADA. Could you provide some perspectives on those two assets and why is petrelintide differentiated versus those assets? The second question on the Roche partnership. Could you discuss potential cost share structures on R&D? Are there any caps to spend for Zealand? Could you give us a sense of how much you and Roche plan to spend both on the development of petrelintide and the combination asset? Thank you very much.
Thanks a lot for your questions. If I start with the Roche, it's a true, you can say, 50/50 agreement where we will also share the cost in R&D, not when it comes to investments in manufacturing or building up the supply chain. That is the responsibility of Roche. From an R&D perspective, we will share the cost. As Henriette also alluded to during her part of the presentation, we are confident that with the cash we have at hand and the expected near-term milestones, we can cover our part and on top of that, increase investment significantly. We are not yet providing clear guidance for what that part will be. We, of course, have a defined clinical development program within the contract, which provides opportunities to expand beyond that if we decide to do that together with Roche.
We have ample opportunity to increase investments beyond the commitments we have into the program as it stands today in the plans, including pre-launch commercial activities. On the competitive landscape, you can say, of course, as we have also said for a long time, because amylin is such an attractive category, we should expect to see more competition in the future. We feel very confident around the best-in-class potential with petrelintide, which I think is also exemplified by the deal we announced recently and the consistency of the data that we have demonstrated across several clinical studies thus far. Also, you can say when we look at timelines to market, we feel very comfortable in the position that we are sitting in now, in particular also with Roche as a partner.
As everyone knows, and as you also alluded to, Lilly, they are expected to release data from their amylin-only analog later this year. They have just closed another amylin program, which was based on salmon calcitonin. I think that's a category that has repeatedly been closed, at least in how we understand the market. Now they are solely focused on an amylin-only molecule. We have not seen clinical data from that program, whether they're going to pursue only combination therapies ultimately with tezubitide or also monotherapy. We don't know. The collaboration between Gubra and AbbVie that was announced recently around that amylin analog are some years behind us. You can say so far, at least our understanding is it's a rather inconsistent data set that we have seen. Of course, we need to see more data.
Ultimately, we would expect more competition in this space, probably together with us. I mean, I would say Novo Nordisk is, of course, leading the efforts, not only with CagriSema, but also with this stated ambition of taking their amylin-analog CagriSema. We're going to try it into phase three development in the coming period. In that mix where you can say Novo is approaching phase three with CagriSema, and we look to be the next with what we believe a molecule that has best-in-class potential, we feel very, very confident in our, you can say, journey ahead. Ultimately, we would welcome more competition in this space because we truly think this is the category that can solve the topic we have discussed so much on this call about how do we help patients not only achieve a weight loss, but also weight maintenance.
We just feel that we are extremely well-positioned to lead that category with petrelintide. Also, as we discussed here now that we have the combination with CT388, which would address specific patient segments, further really building around petrelintide as a franchise and as a future foundational therapy for patients with obesity and associated diseases.
Awesome. Thank you.
There are no further questions. I would like to hand back for closing remarks.
With that, we would like to thank you all for attending and for your questions. We look forward to future announcements and updates and to connecting in the coming weeks and months. Thank you.
This concludes today's conference call. Thank you for participating. You may now disconnect.