Gubra A/S Aktie

All right. So, it's 1:00 p.m., and we're ready to get started. So, good afternoon, everyone, and a very warm welcome to Gubra's first-ever Capital Markets event of this type. My name is Adam, Head of Investor Relations at Gubra. And, yes, on behalf of the entire team, we are very happy that you have decided to spend the next couple of hours with us, whether you're here in person or joining us virtually.

Today is, of course, a great opportunity for Gubra to share more about the company, our pipeline and the ambitions for the years ahead. I think probably many of you have seen the press release that we issued this morning, outlining some of the key messages that we intend to discuss in further detail during the presentations today. Just a very quick reminder that, of course, today, we will be talking about the company's 2030 strategy.

So, we will be making forward-looking statements that are subject to risks and uncertainties. Just a few key words on the agenda for today. We will start with our CEO, Markus Rohrwild, who will walk us through Gubra's strategy and ambitions towards 2030. We'll then move into our biotech business unit, including a presentation on our drug discovery platform and overview of the pipeline.

And then we will have an external perspective from Professor Juleen Zierath on the importance of skeletal muscle health, both in an obesity setting, but also more broadly. And then we'll do a deep dive on Gubra's lead proprietary program, GUB-UCN2. After the biotech presentations, we'll do our first Q&A session, followed by a 30-minute-ish break.

And then in the second half, we'll cover Gubra Ventures, our CRO business and capital allocation strategy. And we'll then wrap up with another round of Q&A and some concluding remarks. And of course, for those of you here in person, we hope that many of you are able to stay afterwards for the reception, where I think there should be a good opportunity to also continue the discussions more informally.

All right. So just a brief intro to our first speaker for today. Markus joined Gubra in September last year, bringing more than 25 years of experience in the pharmaceutical and biotech industries. Before joining Gubra, he held senior global leadership positions at Novartis, including as Head of the Cardiometabolic and Ophthalmology business franchises.

He has also served as CEO of several biotech ventures within the Roivant Group. Markus holds a PhD in biological and biomedical sciences from Harvard University. And with that, I will hand it over to Markus to get us started.

Thank you, Adam. Welcome to our R&D event in rainy London. I'm really excited about today's event because Gubra is at an inflection point, and we have set ourselves a new ambition. So we would like our investors to understand where the company is today, where we aim to be in 2030 and why we are confident that we have a credible path to get there.

For the ones maybe also on the webcast who do not know Gubra so well, here are a couple of facts. Gubra is a revenue-generating clinical-stage bioscience company founded in 2008, almost 20 years of scientific expertise in metabolic diseases and peptide therapeutics. We have a validated discovery platform validated through clinical assets and validated through major partnerships with big pharma and biotech. And we also run a very successful growing CRO.

Since the IPO in 2023, the company really has shown strong execution the IPO primarily on the basis of our CRO equity story. Today, we have really demonstrated great potential on the biotech pipeline side. Today, we have 4 assets in clinical development. We have 6 active partnerships with pharma and biotech. Our CRO serves 17 out of the top 20 pharma companies.

And in the last 2 years alone, we have received over $400 million in upfronts and milestone payments from our existing partnership. So that's a great foundation for a new ambition. And I would like to point out our new ambition is based on a very, very solid foundation, and we are evolving and scaling a successful model. Now, where do we want to go?

By 2030, we would like to have 8 to 10 assets in clinical development. We like to bring forward 1 to 2 drug development candidates from our own discovery unit every year. We will be active in 3 therapeutic areas. Of course, metabolic diseases will still play a major role, but we will venture into age-related functional decline, and we will also establish a presence in immunology and inflammation.

By 2030, we will also operate 2 to 3 ventures and create additional value through our growing and successful CRO. What makes Gubra unique? Gubra's business model is unique. We are working with 3 synergistic business units. We have biotech, our key value driver, which discovers and develops novel peptide therapeutics towards clinical proof of concept.

We have our venture unit, which is investing capabilities in great science adjacent to our core therapeutic areas. And we have our CRO, serving external customers but at the same time enabling our internal innovation infrastructure. So, a unique model, but actually quite simple. We serve a single customer. It's the pharmaceutical industry, and we serve a single industry need. It's a need for new innovative medicines.

So, how do we do that? We basically focus between drug discovery and clinical proof of concept; that is a sweet spot for Gubra. Our CRO provides scientific expertise, competitive advantage, and cash flow to Gubra. Our biotech unit creates new peptide therapeutics, which we partner with pharma companies in return for milestone payments and royalties.

And our ventures augment our pipeline via new structures in collaboration with financial investors but also strategic investors. So a point to make, we have multiple ways to create and realize value. In terms of the foundation of our new ambition, I'd like to point out that our platform, our discovery and development platform, is fully validated.

Multiple assets have made it into the clinic. We have made very substantial deals, including our deal with AbbVie last year. And we can rely on this platform to bring new innovative molecules into clinical development. Our pipeline today already has multiple high-value assets, and we will continue to grow that pipeline.

Today, you will hear a lot about GUB-UCN2, our new long-acting urocortin-2 analog. It's a great example of a high-value asset, and Thomas will go into that. We have also assembled an excellent leadership team, and I'm excited that you will hear from all of them today. And another point I'd like to make is the strategic optionality we have today in the company to decide whether we want to bring forward assets a little bit longer towards clinical proof of concept.

Strategic partnering is still a very important aspect. But today, we have more optionality. So this is our leadership team. Let me introduce our speakers today. We have Louise here, our Chief Scientific Officer, an expert in peptide therapeutics. We have Thomas, a leader in translational medicine and early clinical development.

We have Zoe, our Head of Gubra Ventures, a distinguished scientist and company builder. We have Kristian here, our CFO, my right hand, making sure we allocate capital in the right way. And last but not least, we have Trine here today, who has led our CRO business very successfully for many years.

Now translating this into strategic priorities, our key priority is to build a broader pipeline, more key assets in our pipeline, driving value for the company. GUB-UCN2 is certainly our next big thing. Then we will multiply our growth engines. Obesity has been a real fantastic growth engine for us. We have 3 clinical assets in the pipeline just on obesity.

But we want to apply peptide therapeutics to other areas where there's a high medical need and high commercial opportunity. And we believe age-related functional decline is an excellent space we would like to venture in, and we will also establish a presence in immunology and inflammation. On top of that, advancing our technology remains on our forefront.

Longer-acting peptides, oral delivery, macrocyclic peptides, and also continuing our great progress in terms of automation, robotics, and use of AI, all with maintaining a high flexibility and optionality in terms of our strategic progress and investment. A quick word on technology because you'll hear more about this later in the talk by Louise, but also on Trine, and maybe you have seen the great images in the other room about brain and muscle imaging.

We have been using AI-enabled peptide design for many years. And this is an important part of how fast we can deliver new drug development candidates next to our in-house in vivo capabilities. 3D imaging in our CRO is really cutting edge. It's amazing what we can do today in whole-brain imaging and on muscle imaging in conjunction with AI analysis.

And you can probably imagine a company like us here creating tremendous amounts of data sets, and to distill insights out of that, AI is helpful. So we will -- we are actually an early adopter of AI across the company and certainly something where we are standing out. I'd like to emphasize that our R&D platform is disease-agnostic.

We have been very successful in metabolic diseases, but peptides can be applied in multiple areas of biology and indications. We've done a solid analysis on which spaces we feel we can add a lot of value as Gubra and with the capabilities of Gubra, and age-related functional decline seems like a future space of opportunity.

And we do have an opportunity to venture in the space today with GUB-UCN2 because the biology allows us to also address muscle health, sarcopenia, for example, right? On top of that is a broad space of immunology where peptides can add value. And here, we are currently evaluating multiple assets for business development and licensing, and those could be good ones for our first ventures.

I'm very excited about UCN2. This biology will build a new therapeutic space. It's a multi-indication asset. It will go way beyond obesity, and it's a major opportunity for Gubra. We invest substantially behind our clinical program, which has just started. You will hear more about this, but also through a very compelling preclinical program, which will make clear that this asset has multiple indications and the potential to become a major, major asset for the company.

Now a new ambition also needs capital. And you probably know from Gubra that we have always been very disciplined in capital allocation, and that essentially will not change. We invest behind evidence. We are really focused around value inflection points in the context of Gubra; that means clinical proof of concept. Reaching this stage and partnering our assets will create substantial value.

An example of that is the long-acting amylin we have partnered with AbbVie, and Thomas and also Kristian will talk about that. Now, we are in a good solid financial situation. Our current cash position is complemented by the proceeds out of our CRO as well as by the milestone payments coming in the next years from our existing and future partnerships. So all of this together will make our ambition possible.

Keep in mind, the area we are focusing on, discovery to clinical proof of concept, does not require major capital allocation. We don't invest in expensive Phase IIb or Phase III. That's usually what our partners contribute. So our goal of creating 8 to 10 assets in clinical development, including our proprietary, venture, and partnered assets, is not outside our reach, and it's financeable.

Also the fact that we want to have 1 to 2 drug development candidates every year from our own drug discovery is within reach. We just have doubled our R&D capacity in Horsholm with a new building this year. And I'm confident that we will continue to bring out new exciting medicines, adding value with 2 or 3 ventures launched and operated in lean asset-centric companies by 2030.

And of course, I believe our CRO, our preclinical specialist CRO, is differentiated. We focus on high-value areas to add value for our pharma and biotech clients, and that will continue to grow and will remain very profitable for us. And with this, I will hand over to Louise.

Thank you, Markus. My name is Louise, and I will take you through the biotech unit. And the biotech unit is Gubra's core value driver. This is where we take innovative ideas, turn them into differentiated peptide therapeutics and take them to clinical proof of concept. Fulfilling the pipeline is a core focus for all pharma and biotech companies globally, and many rely on sourcing external innovation.

Gubra is part of the solution. Over the years, we have built a strong pipeline of differentiated assets. At the center is an AI-driven drug discovery platform, streaMLine. The strength of the platform has consistently been validated through multiple clinical assets and partnerships with leading pharma and biotech companies.

At Gubra, we are peptide experts. All the work we do is done using an in-house developed AI-driven drug discovery platform, streaMLine. A core advantage is that the platform combines AI-driven design and data analysis with high-throughput wet-lab screening of multiple peptide libraries, thousands of peptides. We use multiparameter optimization. So, this means that we don't just optimize 1 parameter at a time; we optimize all parameters simultaneously.

In the end, this will enable us to save time and identify better molecules at speed. Over the years, streaMLine has repeatedly generated multiple peptide assets with blockbuster potential. Beyond streaMLine, continued platform innovation is key to make sure that Gubra remains at the forefront of peptide therapeutics. So the current toolbox that we have today already provides a strong foundation for pipeline expansion.

We have streaMLine at the center, complemented with capabilities within de novo design, multi-agonism, and peptide-peptide conjugates. And we continue to innovate towards 2030. Technologies of particular interest to us are long-acting technologies to enable less frequent dosing, but also macrocyclic peptides, which could be an important enabler and a first step towards oral delivery of peptides.

Collectively, this will support a 2030 strategic ambition of building a broader late-stage clinical pipeline and increase the number of development candidates that we can generate every year. So, many companies have a drug discovery platform, but the core strength of the platform is measured by the quality of the output and whether these assets can repeatedly go into the clinic.

Our platform has consistently generated differentiated peptide therapeutics that have advanced into clinical development. This is evident from the pipeline shown here. This pipeline is a direct result of the power and efficiency of our drug discovery platform. It covers both our internal proprietary assets that are not yet partnered and our partnered assets that have been progressed through strong partnerships.

Starting with our internal proprietary assets. The most advanced internal asset is the long-acting UCN2 analog currently in Phase I for the treatment of obesity. And you will learn much more about that later from Thomas. And at the same time, we continue to advance the next wave of future opportunities for Gubra, including new assets within obesity, but also beyond obesity, for example, sarcopenia and cachexia.

Turning to the partnered programs. The 2 most advanced programs are the Phase II partnerships within obesity with AbbVie and Boehringer Ingelheim. Beyond obesity, we also have other highly interesting programs in collaboration with leading biotech companies. We have the Hemab, the Amylyx and the Camurus collaborations, and they truly illustrate the platform's versatility and opportunity to go beyond obesity and consistently generate differentiated peptide therapeutics across a broad range of therapeutic areas.

But now let's take a closer look into some of these assets. Starting with obesity. At Gubra, we have been dedicated to treating and understanding obesity since the company's inception. And over the years, we have built deep scientific expertise all the way from discovery to clinical translation. And today, we'll take a closer look at some of these assets, each designed with a differentiated profile compared to current standard of care and with blockbuster potential.

But before getting into the data, let's just take a step back and take a closer look at the overall obesity treatment landscape and where the field is heading. Because it's no secret that obesity continues to be a growing global health care challenge, and there is a well-acknowledged need for novel treatment approaches. By 2035, it's estimated that more than half of the global population will be living with overweight and obesity.

And at the same time, treatment penetration is really low with less than 2% receiving active treatment. So there is a huge unmet medical need here. And one of the core issues is that today we're actually treating obesity as if it's 1 disease, but it's not. Obesity is a complex heterogeneous disorder. Different patients have different biologies and different needs. So we need more tools in the toolbox if we want to treat all patients efficiently.

For the past decades, a core question with obesity treatment has been, can we make patients lose weight? This was the focus for the first generation of obesity treatments really spearheaded by the first generation of incretin therapeutics, the GLP-1s. The focus for the current wave has been to maximize efficacy and improve tolerability. Here, we've seen the introduction of alternative and complementary modes of action.

We've seen amylins, dual and triple agonistic concepts emerging, and there has been amazing progress. But it's also well acknowledged that body weight reduction is not just fat mass. Lean mass actually accounts for 25% to 40% of the weight loss. And lean mass is muscles, it's bones, it's internal organs. So it's basically all the tissue that we would ideally like to preserve when we're trying to lose weight.

Therefore, we believe that the next wave of obesity treatment will increasingly focus on the quality and not just the quantity. So in other words, improve body composition by maximizing fat mass loss and improve muscle mass and function. That is where the field is going, and Gubra's pipeline is strategically positioned to meet these emerging trends.

So across our proprietary and partnered portfolio, we now have 3 clinical-stage assets in our pipeline, each addressing obesity from a different biological angle to address important unmet medical needs in the growing obesity treatment landscape. We have ABBV-295 by engaging with the amylin receptor biology. We have the triple agonist by engaging with 3 complementary modes of action involved in body weight reduction.

And finally, we have an internal long-acting proprietary UCN2 analog building on a completely novel concept of improving body composition and muscle health. Now let's take a closer look at some of these assets. Starting with the triple agonist. This is a long-acting first-in-class triple agonist, and it targets the GLP-1, GIP, and Y2 receptors to engage in 3 complementary modes of action involved in body weight reduction.

From a biological perspective, this is highly attractive. GLP-1 and GIP are 2 well-known incretin receptors with well-established effect on glucose and body weight regulation. Adding the Y2 component introduces a non-incretin mode of action, and the Y2 receptor is an important regulator of hunger. So the underlying scientific hypothesis is that by engaging with these 3 complementary modes of action, we can achieve better body weight control compared to engaging with each receptor individually.

So the program was discovered in collaboration with Boehringer Ingelheim, and they're now responsible for advancing it through the clinic. And after seeing positive Phase I data showing a favorable safety profile and a body weight reduction, they have now initiated the Phase II study. The study will enroll 300 participants, and the primary endpoint is body weight reduction after 42 weeks of treatment. We see this as further validation of the asset's potential and of Gubra's discovery capabilities.

Now let's turn to amylin. Amylin offers an attractive alternative to current standard of care. Amylin is an antagonist peptide hormone released from the pancreatic beta cells, and it has a well-established role in glucose and energy regulation. And importantly, amylin is not an incretin. It activates a different set of receptors and mediates the effect by a distinct and complementary mode of action compared to GLP-1s. So this means that amylin can be used as a stand-alone treatment or in combination with an incretin.

So the class of amylin have repeatedly shown to deliver competitive body weight reduction with a favorable tolerability profile. This is evident from these 2 clinical data sets. On the first set here, you see the Phase II data from the Phase II trial with eloralintide. Here, you can see that eloralintide can produce a competitive body weight reduction. On the other slide, we have the Phase III data with cagrilintide. Here, you can see that cagrilintide can deliver body weight reduction that is clinically relevant with a favorable safety profile.

So, you can say that's exactly the type of biology we're talking about when we're talking about expanding the toolbox for patients living with obesity and why we find it so compelling in context of 295. 295 is a differentiated amylin analog discovered at Gubra, out-licensed to AbbVie. It has a balanced receptor profile on the amylin and calcitonin receptors just like native amylin, and it has a very long half-life of 11 to 12 days. This means that there is the potential to go with every second weekly dosing or even monthly dosing.

In addition, it has a delayed time to Cmax. So this means that there's an almost built-in titration in the molecule, which could potentially explain the favorable tolerability profile. Across the comprehensive Phase I studies, 295 has consistently demonstrated competitive clinical data. Early signs of body weight reduction were seen in the SAD study. Here, 1 injection with 295 led to a body weight reduction. This was further substantiated in the 6-week MAD study, where 6 weeks of treatment with 295 led to an almost 8% reduction in body weight. And finally, in the 12/13-week MAD study, 295 delivered almost 10% reduction in body weight.

Across all studies, 295 was well tolerated, AEs were predominantly mild GI-related and transient. So there's another Phase 1b study ongoing right now with ABBV-295. This study will include a bigger proportion of female participants and a higher BMI range, and this is to generate data in a more representative patient population. But now let's take a detailed look at data from the 12- plus 13-week MAD study.

This slide shows detailed data from the Phase I study presented recently by AbbVie at EASD. What you can see is that 295 delivers a competitive body weight reduction, dose-dependent, of almost 10%. I also want you to pay attention to 2 of the dose cohorts here, the yellow one and the green one. Here, we see competitive body weight reduction with every second weekly dosing or even monthly dosing. And remember that this is in a patient population being predominantly male with a lower BMI range.

So key highlights here is that 295 delivers meaningful body weight reduction of almost 10%. It has a favorable safety profile, and the pharmacokinetics supports every second weekly or even monthly dosing. So, based on these encouraging data, AbbVie has now initiated the Phase II study. This is a comprehensive study enrolling 360 participants, 6 active treatment groups, and the primary endpoint is body weight reduction after 32 weeks of treatment. This is to get timely data for a potential Phase III study, while treatment will continue through Week 52.

So to summarize here, the class of amylin provides an attractive treatment alternative compared to current standard of care. 295 is a differentiated amylin analog that has the potential to become an important tool in the obesity treatment toolbox. It also exemplifies the Gubra Biotech operating model, where we take a differentiated peptide, take it to clinical proof of concept, and generate further value through strong partners.

Beyond obesity, we also have 3 highly interesting programs in collaboration with leading biotech companies. The Hemab collaboration centers around the long-acting plasmin inhibitor that we have discovered in collaboration with Hemab for treatment of bleeding disorders. Hemab has now initiated the Phase I study with this asset. Next, we have the long-acting GLP-1 receptor antagonist discovered in collaboration with Amylyx for treatment of post-bariatric hypoglycemia. Amylyx is now running the IND-enabling activities with this asset. And finally, we have the PTH analog that is being formulated in Camurus' FluidCrystal technology to generate long-acting treatments for patients with hypoparathyroidism.

So, collectively, these programs demonstrate the versatility of our drug discovery platform to repeatedly generate differentiated peptide assets across multiple disease areas. And you can say that's exactly the versatility that gives us the opportunity to think beyond obesity and to go into new therapeutic areas in the future.

So, to summarize, the biotech is Gubra's core value driver. This is where we take innovative ideas, turn them into differentiated peptide therapeutics, and take them to clinical proof of concept. Over the years, we have built a strong pipeline enabled by AI-driven drug discovery platform, streaMLine. The strength of the platform has consistently been validated through multiple clinical-stage assets and partnerships with leading pharma and biotech companies.

We have a competitive obesity pipeline. Across our internal and partner portfolio, we now have 3 clinical-stage assets, each addressing obesity from a different biological angle to address important unmet medical needs in the growing obesity market. Beyond obesity, we also have 3 other highly interesting programs with strong partners. These programs demonstrate the versatility of our drug discovery platform and the opportunity to go beyond obesity.

And that's exactly what we want to do, use the same underlying discovery capabilities to repeatedly generate differentiated peptide therapeutics and build a much broader clinical-stage pipeline with time. And with that, thank you for your attention, and I'm happy to turn over to Juleen, who will talk about the importance of skeletal muscle health.

All right. Thanks a lot, Louise. All right. So my background over the years really is on skeletal muscle health. And I think my role here is to do some frame setting and to give you some of the physiology and maybe the molecular biology on why muscle health is important to think about. And muscle is really one of your largest organs in your whole body, and it's incredibly important for maintaining metabolic health.

So it's a major site of glucose disposal and insulin sensitivity. It's a key organ in regulating substrate metabolic homeostasis. And it communicates with other tissues through muscle-derived signals. And I'll mention some later, but they're called myokines. And so it's a real communicator to the whole body. Muscle is really important for physical function. It's important for locomotion. It provides strength and power for everyday movements. It's critical for mobility, for balance, for independence for people throughout the lifespan. And impaired muscle function is associated with poor physical performance.

Now if we think about sort of the lifespan, muscle mass and strength is important and declines with aging. So we see this in the clinic. And if you can maintain muscle mass and muscle function, that promotes resilience and independence in individuals as they're aging. We also see that there's a rising incidence of obesity, and muscle function and muscle health is really compromised with obesity. So muscle health extends well beyond preserving lean mass. And I'm just going to give you some examples about what is muscle health.

So if you look at sort of a cross-section of the thigh, you can see the muscle in the pink colors, you see the bone, you see the fat surrounding the leg. We try to analyze muscle for its quality. So how much muscle is in that leg, and we can do that by measuring the mass of muscle through noninvasive techniques, DEXA, for example. We can look at the quality of muscle, not only the mass, but the quality, what's the condition of the muscle. And we look at the architecture, and we can do that again through noninvasive tools, and we can look at something called myosteatosis, how much fat is, kind of, coming into the muscle itself. How many fibrosis molecules are around the muscle that compromise its quality.

And we also measure muscle function. What can the muscle do? And that can be measured physiologically by looking at strength and physical performance. And this is done by looking at gait speed, grip strength, and other tests that we can do. So it's not just about the amount of muscle we have. It's about the quality and the function of muscle. And these are important things to think about when we think about targeting muscle.

Now when we look at obesity and aging, both of those factors can compromise muscle health. And again, muscle is your largest organ in your body. It's really important. And with obesity, 1 in 4 people globally are going to be expected to be living with obesity. And I mentioned already this myosteatosis. As people have increased visceral adiposity, they also have an infiltration of fat into their muscle that compromises the function of muscle. It impairs the muscle metabolism. It impairs insulin sensitivity, and it leads to this cardiometabolic syndrome. And it reduces the quality of muscle and the function, the performance that people have based on their reduced muscle quality.

With aging, we see that 1 in 6 people globally are aged. They're going to be either equal to or more than 60 by 2035, which is, I'm already 60, so I'm in that category now. And what we worry about with aging is something called sarcopenia. With aging, there's a progressive loss of muscle mass. There's a decline that we all feel in strength and power as we age, and there's reduced physical function and resilience. So both of those aspects are really important when we think about muscle health. And with the weight loss that we're seeing, muscle health may be already impaired before significant weight loss.

So let me dial into some of this weight loss. It's been a revolution in the field to see the therapeutics that have been helping people with obesity lose weight. They lose a lot of weight. But weight loss is not always fat loss. And that's one of the concerns that we have in the clinic. People have been able to lose between 60% and 75% of fat mass, which is extraordinary. But at the same time, they're losing 25% to 40% of lean mass. And that is a cause for concern.

What we in the clinic want to try to do is preserve lean mass, and that is the muscle, the body water, the organs, and other lean tissues. So it's a balance. Not all of weight loss is going to be the kind of weight loss we want to achieve. We want to lose the fat mass. We want to preserve the lean mass. And here are some examples. So I just got back from the EASD meeting, and this slide was everywhere. Everybody is talking about the weight loss we see with the incretins.

This is some data from the SURMOUNT-4 study with tirzepatide. You've all seen this curve. It's remarkable. People are losing 20% of body mass. And as long as they stay on the drug, they do quite well, and they keep the body mass down. But we're seeing that if people come off the drug, and this is only after 36 weeks of treatment, people come off the drug and they stop treatment, they start to gain back body mass. And 2/3 of the weight loss is regained within a year.

And the cause for concern is that if you look over here, the weight loss, 67% loss of fat mass, 33% loss of lean mass. The cause for concern is that when individuals are regaining weight, they're gaining disproportionately, the more fat mass is gained. So when they come off the drug, they gain mass, the mass they gain is fat mass, and they're not gaining back the lean mass, a cause for concern. So the long-term studies in older individuals also suggest that the fat may be regained more readily than the lean tissue. So how can we put a brake on that?

So 2 big questions in the field are, with the weight loss therapies, can we further improve the quality of weight loss, and can improvements in muscle health translate into meaningful functional benefits? And we want to lose the fat mass, but we want to preserve the lean mass or maybe even build the lean mass. All right. So there's multiple biological approaches that are being explored today, and I'll give you some kind of outlines about some of these approaches. And in the next slide, I'll kind of go into some of the molecular mechanisms for what some of these approaches are trying to achieve.

And so we've heard a lot about myostatin, which is a myokine. It's something that's released from muscle and it talks to muscle. And its normal job is to promote muscle -- its important job is to really function on muscle growth and regulation. And myostatin inhibitors can really relieve the inhibitory signals on muscle growth. They can increase muscle mass, they can reduce fat mass. But today, it's not been consistently translated into improvements in physical function and better physical outcomes on the muscle function.

Another approach is inhibin beta E signaling, and this primarily works on the fat tissue. It's called a hepatokine. It's something secreted from the liver. It talks to the fat. And this approach can release a break on adipose tissue lipolysis. It can reduce fat while preserving lean mass. But also like the myostatin inhibitors, this approach has not shown efficacy in improving physical function today.

The other approach we've heard a little bit from Louise is urocortin or the UCN analogs. And this is a strategy to improve muscle protein turnover, so you can promote protein synthesis, you can reduce protein breakdown, and this is one way to maintain muscle mass. There's a potential to preserve or increase muscle mass. And this has been shown to improve muscle function, and it's also been shown to have some cardiorenal benefits, and I'll show you some data for that.

So these emerging approaches can improve body composition through many different mechanisms. And if we look at the myostatin approach, I mentioned this is something that's called a myokine. It's released from muscle. It acts on muscle. And normally, what it does, its normal job is to decrease muscle protein synthesis and increase protein degradation. And this approach is to use antibodies to block myostatin -- to block the myostatin molecule, and it inhibits the receptor binding and it alters the signaling. And what it will then do is increase muscle protein synthesis and decrease protein degradation. And it's a way in which one can maintain muscle mass.

And there are some clinical approaches already out there, myostatin inhibitors, where bimagrumab is a molecule already been tested in clinical trials, a 48-week trial, where this therapy has been shown to lead to a modest reduction in body weight, a 25% loss in total fat mass. And at the same time, there's a very modest improvement in lean mass, and this is the blue bars. And if you compare that to sema, you can see that it's very much equal in terms of its body weight loss and its effect on weight loss, fat mass loss, but sema causes a loss in total lean mass.

So the idea here is that the bima is one approach to be able to lose fat mass and at the same time, have a weight neutral for lean mass. And I think what's very intriguing is that when individuals are getting a combination dose of bima and sema together, they have a pretty striking change in body weight. They have an even more robust change in total fat mass, but they do not have a change in lean mass. So it's one way in which one can dial down fat mass and dial up potentially or maintain lean mass. So body composition can be improved. But in this case, the functional benefits on the preservation of muscle mass have not been convincingly demonstrated.

The other approach I mentioned earlier is this inhibin beta E, which is a molecule that is secreted from the liver and it talks to the fat cells. So it's a way of communicating between liver and fat cells. And its normal job then is to be released from the liver, talk to the receptors on the fat cells. And normally, what it does is it downregulates lipolysis and it increases fat storage. And the approach here would be to block the production of inhibin beta E, block it in the liver so that it cannot talk to the fat cell. And it would put a brake on the fat cells to increase lipolysis and decrease fat storage.

So it's a way in which one can then target weight management independent of body food intake. And so -- and this is an experiment where there's been an siRNA approach that targets the liver that can silence the production of inhibin beta E. And what it does then in a time-dependent analysis where it's 1 dose treatment, you've got 3 months and 6 months treatment, and it's been shown to lead to a reduction in visceral fat mass, and this is the fat mass that really one wants to target in the clinic, the body fat.

There's a reduction in total fat mass, and there is an increase in lean mass, and they're body weight neutral. That's because you're losing fat and you're increasing lean mass. And so this is one approach to improve body composition, but the effects again on physical function remain to be established. So these are 2 approaches that are already being tested.

Now urocortin analogs are unique in that they target not only one organ, they can target muscle and fat. And these peptides are physiologically produced from multiple organs in the body. And this approach with these analogs is to target both muscle and fat. And targeting muscle, the receptors are highly expressed in the muscle cells. They promote anabolic or growth-promoting effects in muscles, and they improve metabolic signaling. And there's preclinical evidence in animal models for preserved or even increased muscle mass, and there's preclinical evidence for improved muscle function. And that is something we don't see with the other approaches. So it really does something more, and it affects the adipose tissue.

So the urocortin analogs can regulate the fat metabolism. They promote lipolysis. They basically burn fat out of the fat cells. They lead to energy mobilization, and there's preclinical evidence for a preferential fat mass reduction. And as I mentioned earlier, this is a tissue effect that goes beyond appetite regulation. So this approach is interesting because it holds promise for fat loss with preserved or even increased muscle mass. And I'll give you some examples.

So these are preclinical studies. They're all done in rodents. And the first 2 panels, the left and the middle, are a study actually from my lab, and they're in a mouse model where the mice have been fed with a high-fat diet for weeks. So they become obese and they become insulin resistant. And these mice are either sedentary or they are given wheels and they can run in a cage. And we found that when we treat the animal with the UCN peptides, they reduce their fat mass. And in the middle panel, we take out a muscle from the animal and we weigh it, we can show that with the UCN treatment, they have an increase in muscle mass.

In a study where we've done some casting where we've immobilized animals and their muscles atrophy, we can show that there is a loss of muscle mass in the blue bars. If we immobilize -- sorry, if we immobilize the animal in the green and treat them with this vehicle, they have an atrophy in the muscle. And if we treat them with the UCN peptides, they maintain their muscle mass even though they're immobilized. So this would have some implications for bed rest or sarcopenia that UCN2 peptides could preserve muscle force with immobilization.

So the other thing that this approach has beyond the myostatin inhibitors and the inhibin beta E is that they have cardiorenal protective qualities to them. And there's preclinical and clinical studies that provide evidence to suggest this. So if we look at the cardiovascular effects, this has been demonstrated in humans. There's been effects on cardiac output, left ventricle ejection fraction effect, and there's reduced systemic and peripheral vascular resistance, and this has been seen in even healthy people and people with heart failure. And the renal effects have been shown in preclinical models where there's improved creatinine clearance, reduced renal injury and inflammation. And these effects may be both direct and they have -- because of the hemodynamics that we can see. And I'll dial into some of the primary data that supports these assertions.

So this is the cardiovascular parameters. It's a study in humans where people have been infused with urocortin-2 analogs, and you've got the control in the blue and the dark is the urocortin-2 analog that's been infused into these people, and it shows that it improves cardiac output. It shows it improves blood pressure. And in an ovine model, it's been shown that there is an improvement in urine sodium excretion and also kidney markers of inflammation, fibrosis are also improved by these relatively short-term exposures to urocortin-2 analogs.

So just the take-home message here is that, first of all, muscle health is incredibly important for physical function and healthy aging. Weight loss, it's not all the same. Chronic weight management should extend beyond weight loss per se, and we should focus on preservation of lean body mass, looking for healthier body composition and function. And the urocortin biology offers potential across not only body composition, muscle function, but also the cardiorenal health parameters. So that's a little bit of the science behind the molecules. And with that, I'm going to turn over to Thomas, and you will probably dive deep into your portfolio here.

Thank you, Juleen. So my name is Thomas. I'm Chief Medical and Development Officer at Gubra, and I would like to discuss our development program, GUB-UCN2. And I would also like to highlight why we believe that GUB-UCN2 could be the next potential value driver for the company. So we have just heard obesity treatment is really entering a new era. Incretin therapeutics have demonstrated how much weight loss we can really achieve with pharmacotherapy. However, we do see a substantial reduction in fat mass, which is desired, but also a reduction in lean mass, including skeletal muscle mass, which is undesired.

So the next opportunity is to improve what patients lose, what they keep and how they function. GUB-UCN2 has the potential to address exactly that gap by improving body composition and potentially also improving physical function. So today, I will explain you the preclinical data set supporting the value proposition. I will talk about how we intend to translate that into the clinic and how we view the broader indication expansion potential in order to maximize the value of GUB-UCN2. So the presentation will follow the 3 areas summarized on this slide.

I will first briefly summarize the mechanism of action and walk you really through the preclinical data set. I will then talk about how we translate the findings into the clinic and how we test what parts of the biology really materialize in a clinical setting. And finally, I'll come back how we use this data set along with additional clinical and preclinical data to think about further indication expansion. So let's start off with the mechanism of action and the preclinical data set. So you have seen this slide before. Native urocortin-2 signals through a receptor called CRHR2 and the peripheral biology involves the target tissue that is really relevant for the therapeutic purpose we are developing GUB-UCN2 for.

So specifically adipose tissue and muscle tissue. In the adipose tissue, UCN2 can reduce fat mass. In the muscle tissue, UCN2 can drive anabolic processes, inhibit catabolic processes and drive oxidative metabolism. And that together is the biological rationale for developing GUB-UCN2 in obesity with the purpose of improving body composition. The biology extends beyond adipose tissue and muscle into the heart and into the kidneys where we have seen that UCN2 can improve cardiac function, can drive natriuresis and diuresis in the kidney. And that in itself is the biological rationale for thinking about indication expansion opportunities into the cardiorenal space.

So on the left-hand side of the slide, you see the key product characteristics of our UCN2 analog, which we are calling GUB-UCN2. It's a 38 amino acid peptide, which is highly potent and highly selective for the CRHR2 receptor, and it's formulated for a convenient once-weekly subcutaneous administration. So the development ambition is derived from the biology and from what we would like to achieve for the patients, driven by medical need. We would like to start off with looking at healthy body composition, right, with a question, can we really reduce fat mass and improve muscle mass.

Improvement of muscle mass is a good thing to do. But the next question, of course, is does it translate into improved muscle function, right, and improved physical function and improved muscle strength. And that's the second aspect we are going to address. The third question is, how are we going to use GUB-UCN2 in the clinic? Is it going to be used as a monotherapy in combination with available obesity treatments or potentially as a follow-on treatment once patients have achieved substantial weight loss. This is what we are going to address both in the preclinical as well as in the clinical setting.

And finally, I spoke about it briefly, how do we lift the full value of GUB-UCN2 by looking into indication expansion opportunities, right? And across all these indications, we are looking at once-weekly subcutaneous administration of GUB-UCN2. So now let me dive into the preclinical data set. So we have evaluated GUB-UCN2 in 2 species in mice and in rats, and we used obesity models based on high fat diets for both species. And what is really common across species, and I'll walk you through the data in a second, is that we can indeed improve body composition.

We do see a substantial reduction of fat mass and preservation or increase of lean mass. So the first data set on this slide shows data in mice that were treated for 4 weeks with GUB-UCN2. And you do see on the left-hand side that we see a dose-dependent reduction in body weight. And you see in the middle graph that this body weight reduction is predominantly driven by a reduction in fat mass while we maintain lean mass in these animals. And body weight reduction and reduction of fat mass came with additional improvement of other metabolic parameters.

So we have an improvement in glucose metabolism. You see on the left-hand side here, glucose-related hemoglobin A1c, and that goes down as does triglycerides and total cholesterol. So this is also a favorable metabolic profile that we are achieving with GUB-UCN2 treatment. So we have also evaluated GUB-UCN2 in rats, and this slide summarizes data from a 12-week treatment study. Monotherapy was evaluated and compared with treatment with semaglutide and the combination treatment. The mono treatment is depicted here by the green bars. And you can see in the middle and on the right-hand side that we do achieve a substantial reduction in fat mass, and we do see a substantial increase in lean mass.

The overall effect was weight neutral with GUB-UCN2 as a monotherapy. If you look at semaglutide, which are the purple bars, we do see the expected weight reduction. But what we see in contrast to GUB-UCN2 is a reduction in fat mass, but also a slight reduction in lean mass. If we now combine both treatments, we can maintain the weight reduction that we have seen with semaglutide in the combination, but we can favorably modify the body composition by further decreasing fat mass and increasing lean mass. This is exactly the desired profile that we would be looking for.

So we have now also thought about what are other potential combination partners for GUB-UCN2, and we specifically looked at tirzepatide and an amylin analog. And the next slide shows the data from a treatment experiment using tirzepatide as a comparator and as a combination partner. GUB-UCN2 monotherapy, again, is depicted by the green bars, where we see exactly the same effect here already after 4 weeks of treatment. And we do see that we have a substantial reduction in fat mass and increase in lean mass with a weight neutral effect.

Tirzepatide behaves as expected. It reduces body mass. These are the aqua bars, but it also reduces beyond fat mass lean mass. And if you again combine and these are the dark blue bars, we do see that we can maintain body weight, but further reduce fat mass and increase muscle mass. Exactly the same pattern with an amylin. And cagrilintide was used in this specific experiment, again, a treatment period of 4 weeks with the same findings for GUB-UCN2 monotherapy. Amylin therapy alone resulted in the expected body weight reduction.

And again, we did observe a reduction in fat mass and a reduction in lean mass. With the combination, we got a much better body composition and that we could further reduce the fat mass and increase the lean mass. So this basically tells us that GUB-UCN2 has a favorable effect on body composition, and it does so as monotherapy as well as a combination partner with available obesity treatments or those that are in development. So the next question, of course, is, and Juleen already touched on that, do we actually have an effect on muscle volume and muscle mass itself?

The data I have shown you here are lean mass, of which skeletal muscle is only part of. So we use Gubra's 3D imaging technology to analyze the muscle volume in the hindlimb of these rats. And Trine will speak about the technology in a little bit more detail later on, but the processing involves a clearing of the tissue, a light sheet imaging, building of a hindlimb atlas and then AI-based analysis of the skeletal muscle volume of the hindlimb. And you can see on the right-hand side how the analysis looks like. And here, we very clearly demonstrate that, yes, muscle volume drives at least in part the increase in the lean mass that I have shown you on the previous slides.

So we have now thought about how could GUB-UCN2 be used in the clinic, right? What happens if we discontinue semaglutide, for example, switch to UCN2 or add UCN2 at a later point in time in patients that have been pretreated. And the preclinical setting is reflected here on this slide. So we have conducted a 7-week study where we put obese animals on a monotherapy with GUB-UCN2. These are the green -- is the green line and with semaglutide, this is the purple line. Vehicle-treated animals are the gray line. These are basically the control groups for the experiment.

And you can appreciate that with semaglutide, we did observe the expected body weight reduction, but it came really at the expense of a loss of lean mass. So we have now switched therapy after 3 weeks into the experiment. And this is what the vertical dotted line presents on the graphs. So first, we discontinued semaglutide. So as expected, we did observe an increase in body weight all the way back to vehicle-treated animals. And interestingly, that gain in body weight was almost exclusively driven by an increase in fat mass. You can very nicely see that in the middle graph.

So if we are now switching from semaglutide to UCN2, that means we still continue -- discontinue semaglutide, put the animals on UCN2, we see exactly the same weight curve but the body composition is quite different. The body composition is now driven by a maintenance of the low fat mass that we have achieved in the first 3 weeks and the weight gain is almost exclusively driven by lean mass. So it's quite the contrary that then what we observed with discontinuation of semaglutide. So if we now add UCN2 to semaglutide at a later point in time, we observed the same favorable effect on body composition that we have observed when we initiate both treatments at the same time.

We again see a further reduction in fat mass and a further increase in lean mass. And again, the same question is the increase in lean mass we are seeing in this experiment also driven by increase in muscle mass? The answer to that is yes. You see the absolute weight of the different muscles of a hindlimb of the animal, the EDL muscle, soleus and tibialis anterior and across all muscles, we did observe an increase in muscle mass. So with this preclinical data set, we have shown that GUB-UCN2 drives a favorable body composition with reduced fat mass, increase in lean mass.

We have shown that increase in lean mass is at least in part driven by an increase in muscle mass, which is desired. We have demonstrated that it works as a monotherapy, that it works in conjunction with obesity treatments and that it works as a follow-on treatment. With that, we have now moved the program forward into clinical development. And we have now started a very comprehensive Phase I/IIa clinical trial to look at safety, tolerability, PK and also relevant pharmacodynamic endpoints. It's, as I said, a comprehensive trial. We are targeting an enrollment of approximately 188 participants.

These will be either healthy participants in the SAD portion of the trial or participants with obesity in Part 2 and 3 of the trial. We will test GUB-UCN2 as a monotherapy and as an adjunct to an incretin-based therapy, and we will be looking at body composition and body function endpoints. So this is how the trial is phased. We are currently in the SAD portion of the trial in healthy participants. The key data set we are getting out of this is safety, tolerability and PK as well as the dose selection for the MAD portion of the trial. The data are expected to read out in the first half of '27.

We are then moving on into an obese population in the MAD portion of the trial. Here, the participants will be treated for 6 weeks. And we are going to collect initial data on body composition in the MAD portion of the trial to understand if we get the directional changes that we have seen in preclinical species. And the data set from the MAD trial is expected end of '27, early '28. Subsequent to that, we will be moving into a 16-week treatment arm where we have multiple populations and multiple treatment regimens. And this will allow us to do a full assessment of the effect on body composition as well as muscle function endpoints.

So how are we going to assess body composition and muscle function in the clinical trial? So we will be utilizing MRI imaging for body composition assessments. And Juleen has already pointed out multiple technologies that are available to actually do that. We have decided to go with an MRI because we can really distinguish between muscle volume and other components that are part of the lean mass and that are basically summarized in a lean mass readout with DEXA scan. So we will be looking at subcutaneous adipose tissue. We will be looking at visceral adipose tissue.

We will be looking at fat-free tissue and at muscle volume. The muscle volume is given here by the red color. We then go one step deeper and also image the tie muscles. And Juleen also explained the reason for that because it's not only muscle volume that drives function, it's also muscle quality. And with an MRI technology, we can really look into intra and intramuscular fat and look at potential improvement of muscle quality as a contributor to a functional impact. The functional assessments will include 2 one bucket you might be familiar, is called a short physical performance battery, and that includes 3 tests that we are doing.

It's gait speed, sit to stand and balance. And these are tests that look at very different domains, mostly related really to the lower body because that is very important for movement and independence, which includes mobility, lower limb function and static balance. And the second bucket will be a set of tests where we look at muscle strength, and we will be performing very standardized knee extension tests where we can evaluate lower limb static and dynamic strength. So this, all in all, will allow us to fully assess what biology from the preclinical species is translatable into the clinic.

And it will also guide us in terms of further progressing the asset into other indications. As I indicated, obesity will be our entry point for UCN2. But we are interested in expanding the indication potential beyond obesity. And this slide, again, you have seen it before, puts GUB-UCN2 into the context of our therapeutic area strategy. It sits along with the partnered assets within the core obesity TA, but we really view that as a transition asset that based on functional muscle functional assessments will really allow us to determine if we can drive forward into conditions that are characterized by muscle-wasting and loss of muscle function.

And one of those indications that we are very interested in is sarcopenia. And the rationale for sarcopenia really follows from the relationship between muscle decline and loss of independence. And as you can see here on the left-hand side of the slide, as we age, we lose muscle function and muscle mass declines by 10% per decade in individuals aged 50 and older. This is quite a lot. And at some point, we arrive at a threshold where daily activities become challenging and individuals also potentially lose independence. And this is what we would like to avoid.

Demographics, as depicted in the middle of the slide, increases the need of the scale. And you see that by 2060, it's projected that we have 20% of the population in an age group that might actually be affected by sarcopenia. So we are really talking about a large population. But the population is already pretty large. Now if you look at the left-hand side -- on the right-hand side of the slide, where we have prevalence of 10% to 27% already now in individuals 60 years of age and older. And that extends well beyond obesity. We see that in individuals with a number of underlying diseases like chronic kidney disease, heart failure, COPD and cancer cachexia.

So it's really a growing population and across multiple disease settings. And why is sarcopenia important? If you are looking at this slide, it nicely summarizes the meta-analysis across 35 studies looking at really the impact of sarcopenia on older individuals. So we have almost 99,000 older individuals that drive this analysis. And here, we see a 2.8x higher risk of disability with sarcopenia and an approximately 2x higher risk of falls, fractures and death. So there is quite a significant medical need. And this is basically the basis for the value proposition of GUB-UCN2 in sarcopenia, high unmet medical need associated with an aging population with an increasing and aging population and a therapeutic white space with no approved therapies currently, right? So we are looking at lifestyle management mainly in this population.

So this slide puts GUB-UCN2 into the broader development vision we have for the asset. We start off with body composition, which is very relevant for obesity, either as a monotherapy or in conjunction with available obesity treatments. And clinical data demonstrating functional benefit would also enable us to move into muscle-wasting conditions such as sarcopenia, as I indicated before. We have also spoken about the general mechanism of action and the biology beyond adipose tissue and muscle, in particular, the cardiorenal space is of interest.

And here, we could envision GUB-UCN2 playing a role in improving cardiac and renal function and also improving maladaptive remodeling that we do see in a number of underlying cardiorenal diseases. Long term, GUB-UCN2 could be utilized in the context of healthy aging to preserve mobility and prolonged independence. Each of these indications require their own clinical evidence and their own clinical development program. What is important for us now really is to focus on obesity, deliver the initial clinical data set, understand the translatability of the biology, and that will guide how we embark into indication expansion for GUB-UCN2.

So let me leave you with 3 key messages. Number 1, we have a very compelling preclinical data set that demonstrates that GUB-UCN2 really has the desired impact on body composition in multiple relevant obesity models. Number 2, we have set up a comprehensive clinical program to test the question at hand, which is, do we see the same improvement in body composition with an effect on physical function in the clinic. And number 3, data from the clinical program will guide how we further think about the development of GUB-UCN2 beyond obesity and how we intend to realize the full commercial potential of the asset. So with that, I would like to thank you for your attention. I would like to hand it back over to Adam to moderate the Q&A session. Thank you.

Yes. So thanks a lot, Thomas. I'll now invite Markus, Louise and Juleen back on to the stage, and then we can open the floor for questions focusing on the biotech presentations. Of course, more than welcome also to ask questions of broader strategic character as addressed by Markus in the opening remarks. So please, if you have any questions, raise your hand. We have a handheld mic that we can pass along. So virtual attendees can also hear what we're saying. We'll start here with Thomas. Go ahead.

Thomas from SEB. So a few questions on UCN2 maybe. So first of all, we recently saw Roche also entering the space. So can you maybe highlight a bit on your understanding on your compound compared to the one from Hanmi? Receptor selectivity, PK, whatever we have of understanding here? And then maybe second question, Thomas, you just showed sort of a broad-based increase in muscle volume across the rat leg, I think it was. Do you have any data on cardiac muscle volume as well? So is there any, say, observation, any signs of cardiac hypertrophy, for example, here? So anything we should be concerned about? And also in addition to that, maybe you do highlight the potential in the cardiorenal setting. But does this maybe also highlight that there could potentially be a risk in cardiovascular risk for healthy CV? So just focusing on the weight loss, but in patients without any cardiorenal comorbidities. Can I ask another one?

Let's start with -- yes, I can maybe start off with addressing the questions, Thomas. So with regards to the Hanmi compound and competitor compounds, your first question, right? So I think, first of all, it really shows that there is really substantial interest, right, in the community and in the industry in the biology of UCN2. And we have heard about why that is. It's really a very interesting and very differentiated biology. So at this point in time, the data that are available are very limited, right, on all the different assets, and there are currently no clinical data available, right?

We have multiple clinical programs ongoing, and we will really need to wait and compare the clinical readouts in order to determine, right, whether there is room for differentiation across the assets with the data that are available, this is a challenge. So then with regards to your questions around effects on the heart, we have very closely looked at effects at cardiac effects. And that included basically pharmacodynamic assessments in the relevant disease models and included assessments like the one that you were specifically asking for in our tox program. And from both perspectives, I can say that from a tox perspective, we have no concern with regards to cardiac hypertrophy.

And the contrary is actually the case, right? If you are looking at disease models, for example, heart failure, ischemic heart failure due to LAD ligation, and we have spoken about the data before, then we actually do see an improvement in left ventricular function that is similar or even better than what can be achieved with standard of care. So there is really a case to be made to really develop GUB-UCN2 in cardiovascular indications. I think that addresses probably.

This is Romy from Kempen. I have 2 questions. The first is that there is some evidence out there of differences of acute and chronic effects of corticotropin-releasing hormone receptor 2 agonism potentially due to receptor desensitization. So I was wondering how you're thinking about the durability of effects on adipose tissue and the energy mobilization that you were talking about earlier with sustained UCN2 exposure. Have you also looked at potential desensitization preclinically? And then my next question on strategic -- on the 2030 strategy. So you mentioned you have strategic optionality there. So as you expand your preclinical pipeline, looking at 8 to 10 assets. So how do you envisage continuing to partner most programs around Phase II development? Or do you see Gubra retaining greater ownership maybe to capture more downstream value?

Thomas, let's start with the first 2 related question and perhaps Markus, you can...

Yes, I can start off, Louise, you might want to chime in. It's indeed correct, right, that there are effects that are different, right, if you compare chronic and acute administration, right, in particular, if you're looking at insulin sensitivity and glucose metabolism. And we have not really looked very specifically at receptor desensitization. However, we have compared really the effect of different treatment regimens and treatment duration -- if you compare that, we see that pharmacodynamics is building up with continued treatment duration, which may suggest that this effect is really realizable with chronic administration.

Yes. I think you covered it really, really nicely, Thomas. And you can say you can draw some parallels with regards to GIP receptor antagonism and agonism that also to some extent, can result in the same pharmacodynamic readout. As Thomas alluded to here, we have explored UCN2 treatment for many, many, many weeks in preclinical animal species and have seen consistent competitive results here.

And with regards to your second question, I think it will really depend on the asset -- for some assets, clinical proof of concept may be achieved with grade Ib assets while others will be Phase IIa. For some assets, we may believe we have all the capabilities to -- we need to drive it to such point. For some assets, a potential partner may be really valuable to take an asset earlier. So we will do those decisions asset specific, understanding what is our core contribution and how much value we can generate in-house and what's the best for Gubra. I don't want to generalize that we will develop all assets to make it Phase IIb ready. Because all different indications have specific Phase I programs in terms of how much patients would I need, how much capital do I need to invest, what's the risk benefit to this particular target and biology. So we'll make those trade-off decisions. But for the ones we can do it, we'll probably do it because then, of course, the value inflection, what I get at a partnering stage will be higher.

I think Rune has a hand over here.

Yes Rune from DNB Carnegie. So also on UCN2, first of all, obesity pricing has come down. UCN2 will be an add-on. What do you see the willingness to pay for UCN2 on top of GLP-1? And then back to potential partner discussions. With UCN2, you clearly have a road map for the opportunity. But in the past, you have partnered and then fully out-licensed the assets to the partner, and they decide what happens afterwards. So with this road map, should we be thinking that you would take a stake like a 50-50 partnership on UCN2? Or are you still willing to fully out-license and then maybe not get the potential that you're outlining here today?

Yes, those are 2 very good questions. I think pricing in a market which is more becoming a chronic market over time plays an important role. People will pay for outcomes, right? Obesity is a highly consumer-driven market, right? And people will pay for performance. In the combinations, if you look at other areas like cardiometabolic diseases, type 2 diabetes, respiratory, the prices have come down within the combination, right? That will probably also happen in an obesity context, but the innovation piece will always be priced at a level where you can still have substantial value. But that is a driver.

And I think in terms of what will be the actual partnership depends on the partner, what does the partner bring? What can we still bring into the development piece where we can add value. Some of our partners we have on the triple agonist on the amylin are very good, right? AbbVie is an excellent partner, driving multiple programs, multiple ideas forward, exploring different combinations. They're all in on the asset, right? And I think I feel very comfortable that AbbVie is driving the program. Similar also on the BI side, very keen on driving the program forward as fast as possible because it's a unique triple, first-in-class triple.

So I think for those 2 partners, I wouldn't worry, right? So if we find the right partner, I will probably continue to give them the control over the development program. It also depends on what stage of capabilities in later-stage development we are building over time. But I think at the point today, the deal structure, the partnership structure we have with AbbVie is probably a good blueprint within the time line of our strategic plan until 2030.

Yes. Morten, go ahead.

Morten Larsen, ABG Sundal Collier. First to Juleen, thanks for the presentation. Obesity is a super volatile and fast-moving market and UCN2 may be on the market in 5, 7 years. How would you see the role of a, let's say, a stand-alone project or monotherapy UCN2 in that market in 5 to 7 years? What combination products would you ultimately see this teamed up with?

Part of it, I think, depends on the staging of where people are in their journey of weight loss and maintenance. So I think it would be important to have it early. People are losing weight rapidly tend to be losing more lean mass and that, that you'd want to mitigate that as early as you could. So I'd probably want to have that early when you start to dial down the weight loss. I think females tend to lose a lot more lean mass. So you could think about the sex and also the age of the individual where they're in their weight loss journey. I know I'm not being very specific, and that's what you want. But I think it's going to be more of this precision health, but not to the actual individual, but maybe to classifications of individuals and phenotypes in that journey of weight loss. And I mean I'm a muscle physiologist. So my bias is that I think there's a big role for it, not only with obesity, but with cachexia, injury and aging along the way.

Okay. Second to Markus. You talked about 8 to 10 clinical stage assets. Just to clarify, that is the absolute number you're going to target. It's not the total number you're going to come in and if anyone drops off, right?

Sorry, maybe you clarify again the question.

Okay. 8 to 10 clinical assets by 2030. That's the total number in 2030. What happens if someone drops off or is pruned out?

Yes. This is a total number. Yes, it's a total number. Of course, some of those development programs, it's not sure that will continue. But I think this is why we're also giving a range of 8 to 10. We have 4 today, right? And with our productivity internally plus selective opportunities from the ventures side, I'm very confident that 8 to 10 is realistic.

Okay. Obesity, super volatile and fast-moving market. You already have 3 obesity assets out of those 8 to 10. You want to lean even more into obesity. But as you said, super volatile now with prices coming down half. Is this really the right way to go to be even more obesity focused long term?

Well, we talked a little bit about expanding our TA focus to age-related functional decline and immunology and inflammation. Those are markets which are rapidly developing. So there's great opportunity for us. Those 8 to 10 assets will certainly not be in obesity alone. But given we have 3 already, they will still have a substantial part of our value generation also by 2030. But we are diversifying our pipeline. And we're also lucky to have a disease-agnostic R&D platform, so we can diversify.

Rajan has a question.

It's Rajan Sharma from Goldman Sachs. So firstly, just on the use of MRI versus DEXA scan in the Phase I for UCN2. Has there been any -- I know it's quite early in the field, but has there been any discussion with regulators around that and some agreement there? Just wondering that as this field emerges, if regulatory bodies and potentially academia move towards DEXA scan versus MRI, are you kind of wrongfooted there? So just wanted to understand the level to which you've had those conversations. And then secondly, AbbVie running a combination trial of GUB-295, I guess is it ABBV-295 with lutikizumab in HS. Conscious it's not your trial and you won't be leading it, but you know Amylin pretty well. So I just wanted to understand your take on the rationale for running that trial. And then I've got a third, but maybe I'll do that afterwards, if that makes sense.

Let's start with the first 2. So perhaps, Thomas, I don't know if you can start with MRI versus DEXA and any regulatory input and then we can move afterwards to Louise on 295.

Yes. So it's a good question, right? And DEXA has been the tool of choice, right, for a long time to look at body composition, right, and look at fat mass, look at lean mass. The challenge is that we now have novel mechanisms that are being explored that target a very specific compartment within lean mass, right? And the assessment of lean mas in itself is not sufficient any longer to determine if we have the desired pharmacodynamic effect or not. So we need to move away from DEXA to methods that are more suitable to what we expect from a mechanistic perspective.

MRI is the first step in that direction. You see that now more and more utilized across clinical trials, but the compounds that are using them are not far enough so that regulatory alignment did happen, right? This is an open discussion. Beyond MRI, there are other biomarkers that are being in development that might be much easier to implement in later programs. In currently and correlate with MRI imaging to understand what is really the best biomarker then to carry forward in the development program. For now, we think MRI is really the tool of choice relative to the mechanism of action and what we would like to show.

Good. And then the second question, just to reiterate, I think that was on AbbVie's communication around initiating Phase II trial with 295 and lutikizumab for HS. So perhaps I know it's limited what we can speculate, but perhaps we have some comments, Louise.

Yes. So definitely, you can say, again, it's up to AbbVie to comment on the specific rationale for entering this study. What we know is that a large patient population with HS also, to some extent, obese and overweight. So from that perspective, there is a huge rationale in also reducing body weight in such a study. You can also say that it really shows that AbbVie believes in the potential of 295, not just within obesity, but also beyond obesity. And that is a strong signal for them to be sending.

Okay. Perfect. And then last one was again on UCN2. Kind of hear the comments that you will explore beyond obesity. And I guess if you were to see a very, very strong signal on muscle strength, for example, and there was potential in maybe kind of neuromuscular disorders, would you consider maybe pausing the development in obesity just because thinking from an economic perspective, it's probably a little bit more attractive to be in rare muscular disorders, whether that's an add-on therapy. And I guess, what would you need to see in the Phase I to justify development outside of the obesity space?

Well, I guess that's highly speculative.

That's highly, highly speculative, right? I think we need to see what part of the biology is really translatable into the clinic, right, and really understand if we can have an impact on function. Function is driven by multiple aspects. It's not only the volume, it's the quality of the muscle, it's the capillarization, it's the neuromuscular coupling. There are multiple aspects that need to come together, right, in order to drive muscle function. And this is what we need to further understand, right? And if data are available, we can evaluate and then we can determine what is the right development pathway forward, right? For now, I think the focus is really on getting the data.

Thanks a lot. Any additional questions before we do a break? No, it doesn't seem to be the case. All right. I think please ignore the 3:30 p.m. reconvene. I think we should reconvene here at 3:10. So 10 minutes past 3. Let's do a 30 minutes break.

Thanks a lot.

[Break]

So good afternoon. Welcome back from the break to the audience online, but also here in front of me in London. My name is Zoe. I'm Head of Gubra Ventures. This is our third and most recently launched business unit at Gubra. And before the break, you heard about the strength of our scientific platform, our R&D capabilities and the progress we've made in advancing our internal pipeline.

For the next 15 minutes or so, I'm going to tell you what Gubra Ventures is, why we've launched it now and how it fits into the broader Gubra organization. But before I do that, let me make it absolutely clear what Gubra Ventures is not. And Gubra Ventures is not a corporate venture fund. Instead, you can think of it as our external innovation arm of Gubra. And since we launched in March, we've reviewed over 150 opportunities. And what that's taught us is the pool of external innovation is large, and there is a lot of opportunity for Gubra to apply what we've learned and our expertise to those opportunities. However, to date, we have not yet launched a venture, and that's because we are applying the same high bar to Gubra Ventures that we apply to our internal pipeline progression decision-making.

So what are we seeking? We're looking for credible science, derisked path to development and something where Gubra can really add an asymmetric upside to the opportunity. So how does Gubra Ventures sit within the broader Gubra model? Well, Gubra CRO is our value enabler, and you're going to hear about that shortly from Trine. You've already heard that Gubra Biotech is our value driver. Gubra Ventures is our value accelerator. And what do we mean by that? What we've built at Gubra over the last 2 decades is not just a peptide platform. We've built a proven R&D engine with all the capabilities spanning discovery, translational pharmacology, preclinical and clinical development, but also a proven partnering platform.

Building new tech is a very high investment endeavor. And at Gubra, we don't believe that we need or want to build everything internally. Instead, we will bridge external innovation to use what we already have internally to drive further pipeline value. So what you can see is what we're going to do is broaden the innovation footprint at Gubra with limited capital risk.

So why do we believe now is the right time to launch Gubra Ventures? Successful venture creation requires much more than credible science. Many early biotech companies need to build from scratch all the capabilities that we already have at Gubra today to advance an interesting scientific idea into the clinic. We already have discovery. We already have deep expertise in core therapeutic areas. We understand how to turn a molecule into something that's clinically developable. But importantly, we also have a very strong operational infrastructure. And that means we can focus incremental capital on experiments, decisions and the next milestones to create true value with what we already have today. And that's the core advantage of Gubra Ventures.

So the strategic rationale has 4 parts. We will strengthen our innovation pipeline through external assets and venture creation. We will be able to expand into new disease areas and also new technology areas or modalities beyond our current biotech and CRO focus. We will generate financial returns that can then be reinvested to support future growth at Gubra. And we will build and advance assets using our existing innovation and development engine.

Now selectivity is really central to this model. I've mentioned we've looked at 150-plus assets to date in the last 6 months, and we've got a very deliberately high rejection rate. We must have a clear and active role in creating future value and quality and strategic fit matter much more than transaction volume. So how do we translate strategy into an operating model? We intend to create lean asset-centric companies that leverage our integrated capabilities to really accelerate this value creation. And we will start by bringing in assets and using Gubra functions early. So we do not intend to build large structures around assets, but rather use what we already have today to develop those assets further. At the early stages, we expect this to be a low capital need and a rather straightforward governance with the Gubra majority.

So we will concentrate that early capital on the advancement of the asset to the next milestone. Then when we approach the clinic in IND-enabling, we will add a dedicated team as evidence and capital needs increase, and that will really depend on the skills and capabilities that we need. We still intend at this stage to be a Gubra majority venture, but we will start the outreach to selected investor partners.

Moving into the clinic, of course, the capital needs will step up as well the needs within the venture. And here, we expect to bring in more capabilities in the ventures, but also selected investor partners to share the capital and development risk as we progress those assets forward to the key clinical proof of concept. At that point, we then see several routes to value creation. So we can take the route that Gubra has traditionally done to date, that's partnering. It also includes strategic transactions. But of course, there is a possibility we will continue ownership of these assets and progress those further within Gubra itself.

The principle is consistent. We will match capital, capabilities and ownership of the asset to the needs of that asset. So what is it that we're looking for at Gubra Ventures? We have 3 levers. There's the stage of development. We have the modalities that we can work with and there's also the therapeutic areas that we want to focus on. The aim of Gubra Ventures is to maximize the value opportunity by creating synergies between our existing strengths and the external innovation landscape across all 3 levers.

In simple terms, we see 2 real routes to create value. The first is Discovery Ventures. This is complementary external tech paired with Gubra's scientific and peptide platform through partnerships to expand StreamLine beyond our core therapeutic areas. The second approach, and this is where we're focusing the majority of our efforts at the moment is asset-centric. This is where we're looking for opportunities from development candidate stage through to Phase I that already have some level of technical validation and are therefore, to some extent, derisked either through derisking of the modality, derisking of the target or derisking of what we know about that therapeutic area. The intention is that we will diversify but stay very close to our scientific and CRO advantages.

So in other words, we will diversify without losing focus. We will look in our core therapeutic areas of metabolic and cardiorenal, but we're also expanding into immunology and inflammation. So how do we see this expansion into new therapeutic areas? You've already seen a version of this slide before, and this is how ventures fits into that. So obesity, cardiovascular and renal metabolic disease remains our therapeutic area of core. We have deep expertise in this space. It's the foundation on which Gubra is built and that we are recognized for. We have strong leadership in this area, and we will continue to look for opportunities here, potentially expanding beyond peptides.

Age-related functional decline is the logical expansion for new ventures as we leverage our increasing expertise and leadership in this area, and we're actively looking at opportunities in this space. But I also want to talk a little bit about immunology and inflammation and why we see that as another frontier for us to expand into. Immunology and inflammation is a very large therapeutic area. And despite the advances that we've seen with biologics over the last couple of decades, there's still a huge unmet patient need. There are emerging opportunities in this space as we understand more and more about the biology and underlying pathophysiology in part thanks to those biologics that have already led the way.

We also see increasing interest in peptides in immunology and inflammation. For example, last week, we saw an incredibly high-value deal where Gilead acquired a very early Phase I asset from a stealth biotech called PepStar, targeting IL-23 receptor, a very well-validated target in I&I. And this is a peptide asset acquired for over $1 billion. That tells us that there is an appetite for peptides in I&I, and we're only just starting.

Therefore, we see an attractive venture profile for I&I. This is emerging biology, a high level of pharma interest and subsequently investor interest and multiple routes to eventual downstream value. And I'd like to finish with 3 messages. We are going to use ventures to expand into new therapeutic areas and new modalities to create differentiated value for Gubra. We are going to accelerate the development of those assets through using our integrated capabilities that already exist today. And then we are going to repeat a scalable engine to create more shots on goal and multiple paths to long stream value. We reviewed more than 150 opportunities by maintaining that same high bar for the selection of those opportunities, and we'll be working with selected investor partners as those assets mature and the clinical capital needs increase. And our ambition is to launch at least 2 ventures by 2030. And this is why we call Ventures Gubra's Accelerator.

In practical terms, it's a way for us to broaden our pipeline, diversify our potential future growth and apply our scientific platform to more areas of high unmet need. So I thank you for your time, and I'll now hand over to Trine.

Thank you, Zoe. I'm very excited to be here today. My name is Trine. I'm Gubra's CRO. Yes. So we're leading in the metabolic and fibrotic preclinical CRO industry. We have a proven track record of delivering profitable growth above market average and substantial value to our customers. This is not by coincidence. This is by design. So today, our customers are facing substantial challenges. Speed and innovation, drug discovery is accelerating these years and companies are competing to progress their drug discovery projects as fast as possible with a high-quality data as possible. And this is where the CRO adds value.

We are Gubra's core value enabler. We provide deep scientific and translational expertise, reproducible disease models and advanced technology platforms, and we combine it with reliable, high-quality data and execution. This is really our value proposition to our customers, with our internal customers, the Biotech and Ventures and our external customers.

Gubra was founded as CRO back in 2008. We started out in diabetes and obesity, and we built our strong scientific platform on this foundation, and this is the legacy that we are building our future on today. So we invested in obesity even before it was recognized as a disease. We're also part of the early efforts characterizing liraglutide. And so we built a strong metabolic platform. And in 2014, we spotted a trend in the market. In dialogues with our customers, our network, conversations with academia, publications and conferences, we spotted a trend revolving around fibrosis in the liver. There was an unmet need in the market and no available treatment.

So we decided to expand from our stronghold in the metabolic into fibrosis and MASH. And in the beginning, I said our success is not built on coincidence, it's by design. Let me use MASH as an example of how we have built a successful playbook for creating differentiated, high-quality services and created market leadership. So as I said, in NASH, we started -- we spotted the trend early, and we invested ahead of demand. We developed a clinically translatable GAN DIO-NASH model. And very importantly, we built it ready to scale from the offset.

To enhance speed, precision and data quality, we use machine learning to go from manual scoring of liver sections to AI-assisted histopathology. Also here, we were ahead of the curve, building AI and machine learning directly into our service delivery. We were first in the market with this translational disease model for NASH, and we built early commercial leadership and loyal customer trust.

In 2024, the LITMUS Consortium also recognized the MASH model for clinically top ranked for clinic translatability. And it is now considered a golden standard model in the market. So this is the element of the successful playbook that we have. We invest ahead of demand. We expand from our existing scientific platform, translational platform. We apply cutting-edge technologies, and we gained first-mover advantage in the market. And it is with this playbook close to heart that we've also expanded into other disease areas such as, for example, the kidney area, IPF, lung fibrosis and most recently, sarcopenia and women's health. And I think it will be hard to find a company in the industry working in obesity, in NASH, in kidney diseases that have not worked with us over the years. And our ambition is to continuously innovate and expand from our strongholds to be ahead of the curve. And this model is really amplified by us using cutting-edge technologies.

So as we venture into new disease areas, we always -- it's always accompanied by our strong technology platform in 2D and 3D imaging. And this is an example of our 3D imaging platform. We invested early also ahead of the curve in 3D imaging in 2017. And this technology is really part of revolutionizing the understanding of disease progression and drug distribution. So we started in the brain where we can visualize the entire brain at a cellular resolution to understand the treatment effects. And this is really important for our customers when making drug discovery decisions.

We can map the drug distribution throughout the brain to really evaluate delivery technologies such as the blood-brain barrier shuttles, and also, we use whole-brain c-Fos mapping to show which brain regions respond to treatment, which is also especially helpful in obesity research. And so we transform complex 3D images into quantitative insight through automated analysis and this interactive visualization. And as Thomas was talking about previously, we also have used the technology in other organs, such as, for example, the sarcopenic muscles that you see here where we can measure muscle volumes within an intact hindlimb here being which muscles respond to treatment.

We can quantify vascularization, nerve density and fibrosis to better understand changes in the muscle tissue and we can enable direct measurement of skeletal muscle changes. So this helps customers across therapies aimed at preserving muscle during weight loss or sarcopenia. Also here, I hope you can appreciate the beautiful 3D imaging of an entire ovary in 3D. We can count the [ ovarian ] follicles and to really assess treatment effects without sectioning bias. This technology is what differentiates us also in the market. It's our competitive edge. And while technology is differentiating us at Gubra, automation, digitalization and robotization is really what makes this differentiation scalable.

So automation allows us to increase throughput and consistency without scaling cost and headcount proportionally. This is also an example from our 3D imaging lab where we have high throughput light sheet microscopy. We can handle data from more than 800 brains per month and fully automated staining and sample handling. This robot that we've built, it can also handle hundreds of samples at one time. In this way, we invest heavily in increasing throughput, quality and consistency while reducing manual labor. And this is enhancing the value for our customers and also for profitability at Gubra.

So the commercial value of our entire capabilities combined is really demonstrated by customers choosing to work with us. We've worked with 17 of the top 20 pharmas hundreds of biotechs globally. We have trusted long-term customer relationships, high Net Promoter Score of close to 70, and we have demonstrated a historic growth above market average. Our ambition towards 2030 is to continue to grow from our strongholds at around 10% towards 2030. This decision also -- the strength also become increasingly important in volatile market conditions as we have seen in the past 12 to 18 months. But the market is returning and we see it evolving in our direction as well.

So the market for services in metabolic and fibrotic diseases is still growing. Biotech funding has rebounded. More preclinical R&D is being outsourced towards 2030 and beyond. And there's the growing scientific complexity is also increasing the value of highly specialized services. And this is where our value proposition is extremely clear. We provide deep scientific, translatable expertise, reproducible disease models and highly advanced cutting-edge technologies and high-quality, consistent data and execution. So we're well positioned to -- we believe, to capture the growth that we foresee in obesity, in NASH, in kidney diseases. And we also believe that we can -- that these areas in sarcopenia and women's health represent attractive opportunities for us in the future.

Both areas fit our playbook very well. There's an unmet need in the market, no or few available treatments. There's a growing focus in drug discovery on these diseases and in academia as well, and we have invested ahead of demand. There's a strong fit with our scientific and translational platform and scientific expertise, and we can combine it with our leading 2D and 3D imaging capabilities. So this is why we expect to have an attractive first-mover advantage in these 2 disease areas.

Our ambition towards 2030 is to remain a leader in this industry. We've shown that we can deliver profitable growth year-over-year above market average. We've shown that we have the guts and the brains to invest early ahead of the back demand. We have the capabilities. We have the customer trust, and we have the strategy to scale this competitive advantage towards 2030.

Thank you for your attention. And now I will hand it over to Kristian.

Thank you, Trine, and it's a pleasure to talk about one of my favorite topics, capital allocation. My name is Kristian. I'm CFO in Gubra. So you heard my colleagues speaking about where we play and how do we win and our strategy towards 2030. Capital allocation is really how to turn this strategy into action to create long-term shareholder value. What assets we prioritize under what conditions, what activities we fund. So it's a real pleasure to be here to talk about that across Gubra.

So if you look across Gubra and starting with the Biotech discovery business here, I've graded the different business activities in terms of capital intensity. This is significantly less capital intensive compared to biotech development. Our discovery engine is where we develop novel differentiated peptides. We invest to master new type of peptide technologies like Louise talked about, macrocyclic peptides, oral delivery, long-acting peptides to really stay at the top of the peptide field.

When we have assets, of interest, we progress them and we make data-driven decision. I will come back to that shortly because when Louise delivers something to Thomas' organization, the Biotech development, all we know is that costs will rise. So it's so important to only progress those assets, which will have high potential and weighing risk and return. So we'd rather, as Zoe also said, progress few assets rather than striving to build a large pipeline. So very selective in our choices and data-driven decisions.

The ventures is essentially an extension of the Biotech business. We want to have more shots on goal, more biotech assets in development. But importantly, the venture is a vehicle to progress assets but with limited capital at risk. So essentially, we can put an asset in an asset company, get external funding at the project level and have the ability to progress more assets without committing too much capital.

The CRO business is a service business. So in terms of capital intensity is fundamentally different. There we invest to develop new service areas, new technology areas, as Trine talked about in the 3D imaging field, opening up new areas like sarcopenia, women's health, where Gubra invest ahead of everyone else. So we are willing -- when we have a conviction that we think an area where we can master and we think demand is there, we're willing to invest to broaden out our service catalog of offerings so we can remain the preclinical specialist and the go-to place for preclinical tests.

The biotech business, everyone that has worked in the biotech business knows that the capital requirements increase alongside the development stages. So in order to drive the R&D efficiency, it's so important to make all development decisions based on rigorous data. So whenever we progress an asset, we also have a lot of assets that do not pass the bar. So we have this failing fast concept. So whenever we're looking at the assets at certain development stages, has some on whereas others will not progress because again, the capital commitment, the capital requirements increase significantly and especially as you approach and go into the clinic, it's so important to be selective.

And as Markus talked about, we want to drive our assets to pre -- sorry, clinical proof of concept, and we want to make sure we have really strong assets that we enter when we enter the clinic. So you can think of us as an asset portfolio manager. We look at the assets and we choose the assets we want to fund and proceed. Of course, a really great example is the amylin asset. That project started in 2018 and starting working with the molecule and ensuring we had all the properties we would like from a peptide.

In biotech, you need to have patience. So it takes years to progress the assets and the amylin made it through various development stages, whereas some other ideas did not because we have high bars and those assets will progress, they have the properties we would like to see from our peptides. We started the Phase III back in '23. And then a year later, we had the first clinical results. And just a few months after that, we made the landmark deal with AbbVie of USD 2.2 billion, including a very sizable upfront of USD 350 million. So here, we turned an investment of around USD 25 million into USD 2.2 billion. So quite a high return on invested capital.

And we also returned funds to shareholders also last year in terms of an extraordinary dividend. So a very good blueprint case in how you should expect and how we want to develop our assets and that we are very selective among those we progress. The amylin, ABBV-295 is not the only strong asset we have partnered out. We also have the triple agonist as Louise and Thomas talked about, the Hemab collaboration, the Amylyx collaboration and the Camurus collaboration.

So a number of recurring, hopefully, also in the future recurring revenue streams that provide us with good funding to fund the investments in new R&D assets. Just repeating a little bit what Zoe said on Gubra Ventures. So here, we have the ability to get really interesting science without taking too much risk. So we can in-license an asset, put it in an asset company, get external funding at the company, asset level, project level and then Gubra will contribute with capital, and we will also invite investors to that project.

So it's really a way to accelerate our biotech business without taking too much risk. It's a way to get more shots on goal because we're very mindful of having capital discipline. And this is a vehicle that we can use to drive more assets in parallel without, again, taking too much risk and too much capital commitments.

CRO business. As I said, in terms of capital requirements, it's fundamentally different compared to the other areas. This is a service business that ever since the start has been profitable and growing. So a very asset-light business and very high return on invested capital. So over the last 10 years, it has generated around 14% revenue growth. That's double up compared to the overall industry and profitable. And that's part of having high customer trust. We service 17 out of the top 20 largest pharma companies plus a vast number of biotech clients and they return to Gubra to get the preclinical results to make their next development decision.

So we stand out with our quality and our speed. So Trine talked about Gubra investing ahead of the curve. We go into areas which we think we can master and we get the first-mover advantage. The fatty liver, the MASH field was one example, and we pioneered also in 3D imaging technologies. Now we are looking into women's health, sarcopenia, areas we think we can master and where we can build a strong position as a preclinical specialist provider, be provider to use for preclinical services.

Just a few words on our solid financial foundation. So we have a strong balance sheet. At June 30 this year, we had around $140 million in cash. That is before the milestones from AbbVie, the $50 million and the $10 million (sic) [ EUR 10 million ] from Boehringer. So a very strong financial foundation. The CRO business continues to generate recurring cash flow over the years. So that's another source of funding or cash flow. We have the partner programs, the existing partner programs, and we also have the potential, of course, to enter into new partnership providing recurring revenue.

So multiple revenue streams across the company that gives us financial flexibility to execute our strategy towards 2030. So summing up, it's really important that we invest where we have an edge, where we have a scientific competitive edge, that's where we prioritize our capital allocation. And we selectively choose assets to progress and fund them. And equally important, we deselect assets that doesn't live up to our bar. And we fund it progressively. Each and every asset in the biotech business needs to live up to our rigorous requirements to what we want to see in a peptide. And we also have the venture unit as a possible vehicle to accelerate our biotech business without taking too much capital at risk.

With that, I leave the field open for questions.

Thanks a lot, Kristian. So yes, we will be joined by Zoe, Trine as well as Markus again. And yes, same as before, I'm very happy to address your questions. So please raise your hand if you would like to ask a question. We have a mic that we pass along here. I think perhaps we should start here with Theodora.

I think my questions are going to be directed at Zoe. Still trying to wrap my head around the ventures business. So I was just wondering how do you think about allocating capital between internally developing assets and financing the ventures. So what will ultimately determine what asset stays in Gubra because you also mentioned that, that's also an option of keeping it on or develop through the venture model?

And then a second one, it was previously communicated that the first venture target was for the second half of this year. So I was just wondering when we can expect anything on the first transaction.

Thanks for the questions. So starting with your first question. Of course, what we've described today is that we have an internal pipeline, and we also have Gubra Ventures. And assets will either be brought in under a typical BD in-licensing into our pipeline or when it makes sense, we will create ventures around it. And I think as we progress ventures and we start announcing ventures, you'll understand maybe the model will make more sense, but it's really the asset will go where it has the best home. And I'll leave Kristian to answer any capital allocation questions in a moment.

I think your second question was when will we launch the first venture. You've heard that we've looked at and reviewed a lot of opportunities to date. We're really excited about the advanced opportunities that we have in front of us. And we're as eager to tell you about our first venture as you probably are to hear about it, and that will come in due time.

You want me to expand. I think you could place it in a venture or at Gubra A/S level, I think it depends on both the strategic fit and the financial requirements. So in case the financial requirements are significant, it is a developed assets, then it might be suited for a venture. And if it fits extremely well into the current therapeutic areas, maybe that is more suitable for the Gubra A/S rather than a venture. But then there are gray zones in between. So I think we selectively will look at each asset by asset and how we should develop it as best as possible.

Go ahead, Thomas. Next set of questions.

Thomas from SEB. So maybe just on the CRO division of business. So assuming that you were to maybe even divest that part of the business, what would be the sort of the key risk of weakening or is there any key risks here that we should assume in regards to weaken the biotech business and then maybe also when looking at access to expertise and also operational synergies. So that's my first question.

And then just a bit follow-up on venture. Can you maybe disclose how many opportunities are you actually actively looking at as of today? And then just for clarification during the presentation, what kind of key milestones are you sort of trying to establish once you decide to go with a venture?

Great. Okay. That was 3 questions. So I think for the first question on CRO and potential considerations around divestment, I guess that was essentially the question. I think we can start with Markus addressing that question, and we'll move on to the next ones afterwards.

Yes. I think today, we have no plans to separate the CRO. Keep in mind, the CRO beyond providing nondilutive cash flow to the company has an inherent strategic part to the company. We have the scientific expertise in CRO, all the preclinical models. And it's also a reason why our biotech unit can go from a drug development candidate towards from a peptide to a backbone to a drug development candidate within less than 18 months. So I think there is a substantial strategic value of CRO to the company. And I think the 3 units today work very synergistic and allow us to create value in different ways. So I think the strategic value of the CRO is very important to us at the moment.

Great. And then on the venture, I think Zoe, so you can start here.

Yes, with pleasure. So I'd say we've got a healthy number of opportunities that we're currently looking at and certainly sufficient that we can be confident that at least one will turn into a concrete opportunity in the coming months. I think to answer to your other question, we're taking very much a portfolio risk approach. So of the opportunities in front of us today, some of those could actually be integrated into the pipeline. Others would make sense to become a venture. And they really span everything from development candidate stage through to very close to Phase I and also cover some of our core flagship areas we've talked about. So we're really taking a very diversified approach to what we're looking at the advanced stage to make sure that we are really maximizing the opportunities in front of us.

Yes. Perhaps Morten right next to Thomas.

A question on ventures and questions on CRO. On the venture part, just to help me understand, what would be a typical amount of cash you would allocate to one deal? And do you have some internal IRR requirements for such a deal?

Do you want to take...

You can take that one.

Well, the answer, Morten, is we don't have a specific number we want to allocate to a particular asset. It depends on the development stage of the asset, the size of the disease area and the risk and return. So it's a very general answer to, but it's a very honest general answer. It depends on the asset characteristics. So I think you have to wait a little bit to see the first venture and then we provide an indication of one venture.

That also means you don't have an IRR requirement for the deals in the ventures?

No. So we're not operating like a corporate venture fund. This is really about maximizing our pipeline opportunities, as I said, using what we already have today to generate future value.

Okay. To CRO business. Can you help us explain how you get to that plus 10% growth in that business? The market growth, well, you showed some slide actually showing that the market is going to grow faster than 10%. So how do you get to 10%? That's one.

Two, there's a big rise in Chinese biotech right now, and you guys are not really playing into that. In fact, you guys are very European-centric, which is probably growing slower than the other markets. What is your strategic plans to diversify it outside of Europe?

So for the first question on the 10% growth, I think we have seen the last 12 to 18 months how quickly things can also change and how volatile this market is. So I think 10% is a realistic growth target for us with the portfolio and how we're growing the company in the disease areas that we're focusing on, new opportunities that we will leverage in the future. So I think this is a solid target for -- towards 2030.

In regards to China, obviously, it's a rapidly growing market, and we do see competition from China, especially on price. However, as I was explaining in the presentation as well, scientific complexity is increasing and the need for highly differentiated services, applying cutting-edge technologies and reliable high-quality data is also imminent. So this is where our value proposition is key.

But you don't plan to open an office in Beijing, for example?

That's not currently part of our plans.

Okay. Final question just on this. What has been the growth in the number of projects you have taken? We can see the revenue growth, what has been the growth in number of projects.

So number of projects, new studies that we can take in, in the CRO business. So I think we make a solid business case on the different disease areas that we're venturing into and putting in probabilities and growth rates, it's hardly in volatile market conditions. And we do see a growing market, but it's still uncertain how quickly growth will rebound. Biotech funding has rebounded in '26, but how quickly will we get the benefits of this. There are still some uncertainties built into the models. I think 10% growth towards 2030 is solid.

Very final, if I may, one more.

Yes [indiscernible].

There was no mention of your margin target in the CRO business. You started out with was a 35% EBIT margin, now it's 25%. Where are we going?

So we are guiding on 10% to 15% EBIT margin this year. And we are continuously expanding our commercial activities, driving top line growth and really having a very disciplined cost structure. So this is the balance that we're trying to strike while also growing while also investing in the CRO. So finding that healthy balance is 10% to 15% this year and long term, I think the guidance target.

Well, we don't have an explicit guidance. But you've seen where we've been in the recent years, above 20%. So it's clearly an aspiration to have a strong profitable business without putting an explicit target on where we want to be, right? So we have a good track record of generating profitable growth in the area. And in certain years, the smaller biotech clients, there's a little bit of volatility in those, but the big pharma companies, they provide a solid base for our revenue.

So whenever you see Gubra CRO revenue fluctuating, it's primarily the smaller clients, just as you saw in '23 and '24, we were growing by 30% each year. In '25, the biotech climate was a little less supportive, didn't affect our larger clients, but it affects the delta of the smaller clients. So the volatility comes from the biotech clients, not from the big pharma. They continue to place studies at Gubra. I think we expanded -- I think we had 14 or 15 of the top 20 big pharma companies some 3, 4 years back. Now we have 17. So we see these big pharma companies as a strong foundation and a validation of our preclinical services. And we've been profitable each and every year since 2008 and we will remain to generate return on investment.

Great. Thanks a lot for those questions. Rune, go ahead.

Yes. Rune from DNB Carnegie. So 2 questions on Venture. First of all, you talked about the portfolio approach, but you are targeting 2 to 3 deals until '30. That doesn't really comprise a portfolio. And the second, you talked about 150-plus assets being evaluated. What part of that amount has been Gubra saying no and the other part, the partner saying, we don't want to do this with Gubra or the deal terms that Gubra is offering is not good enough. I'm trying to understand the value proposition that you're offering and how that is perceived.

Yes, 2 great questions. Let me start with the second one first. Almost all of those 150 that we have not progressed have been Gubra saying no. In fact, I'd say all of them so far. And actually, what we're offering is a really attractive proposition to asset holders, and these could be either distressed assets coming from venture-backed biotech in the area that we're working on at the moment, and as I'm sure you know better than me, there's not a lot of venture capital for this early-stage assets. So there's actually a large number of opportunities sitting in Gubra's sweet spot.

So we actually offer a really attractive path to value creation outside of having to raise venture capital. So we're actually seeing a lot of interest in this model. So I'm not worried about that. Regarding your second point, I'd say not every opportunity under in our advanced assessment will make it to a venture for both reasons, it could be us or it could be the partner. So we're taking a portfolio approach when we have the time and energy spent on moving those towards a final deal. But of course, we do not intend, and you've heard me say that and Kristian as well, to have more than 2 to 3 ventures by 2030. So really, we know we're going to be very confident that when we do a deal, it's the right deal and it will somewhere land in our portfolio derisked approach.

And maybe I can add out of 8 to 10 assets in the clinic, if 2 or 3 come from ventures, I think I would consider that a reasonable contribution.

Great. Thanks a lot, Rune. Any additional questions from the audience? Yes Theodora over to you.

I have 2 questions, if that's okay. So the first one is on the CRO business. So you spoke during the presentation and also before that you see women's health as being a key driver of growth there. I was just wondering how that's been tracking so far versus your expectations?

And then secondly, just on capital allocation. So you've spoken, I guess, in detail about how you intend to invest within each of the segments. But I was just wondering how you think about how you split your investment across the segments because, I guess, by the nature of it, by choosing to invest in CRO versus biotech, for example, you're limiting the growth in the other segments.

Thanks a lot. Yes. So let's start with the CRO-related question.

Yes, thank you for that question. As I said in the presentation, we are investing ahead of the curve, and this is definitely also the case in women's health. However, we are seeing an increase in incoming requests for our services. There's a focus in drug discovery, both in big pharma companies and in biotech. And from the time that this interest is arising until it becomes materializes into revenue, it takes some time. But we do see traction in this area, both from pharma companies and from biotech companies.

So in terms of capital allocation, if I should take that, Trine. So fortunately, Trine runs a profitable business. So she can choose with our own funds activities to develop. And this is not an asset-heavy industry. It's adding essentially FTEs to develop areas where we have a conviction that they will -- that we can master those areas. So it's a relatively limited capital requirements to develop new areas, but it takes time. So you can't really purchase an asset to master women's health or sarcopenia. We need to develop that area over years. And we started in '24, and now we're starting to see traction, right? So we need to have patience. But in terms of capital allocation, it's limited.

Great. Thank you, Kristian, and thanks for the questions. Any additional questions? No, it doesn't seem to be the case. All right. So that concludes the presentations and the Q&A. We'll now hand it over to Markus for a few closing remarks as we conclude.

Well, first of all, I would like to thank everybody here in London for participation and also for the people on the webcast. This first R&D Day for Gubra was really an exciting event for us, and it was the first time where we could talk about our new ambition and how we want to address our ambition. So I would like to leave you with 3 thoughts or key messages. Remember, Gubra has great differentiated science and a platform which is disease agnostic. We can create innovation beyond metabolic diseases.

Also remember, we have a very valuable pipeline already. The value creation, which will come from adding multiple high-value assets to that already existing pipeline like GUB-UCN2 will be substantial if we reach our aspiration of having 8 to 10 assets in the clinic. And the aspect that our strategic optionality has substantially improved with our business unit model gives us now more flexibility to allocate our capital and focus on programs and projects which provide the highest value to Gubra and to shareholders.

So the ambition we have put forward today 8 to 10 clinical assets, 1 to 2 new drug development candidates every year, working in 3 therapeutic areas, creating value with 2 to 3 operating ventures plus our very successful CRO, I think, should resonate. And I think we are capable of getting there, and we have the right team in place and the right capital to deliver on that aspiration. And it's all about scaling the successful model we have already. We have a great foundation. And with this, I thank you very much and see you soon, hopefully.

Good afternoon, everybody. Thank you for everybody attending and listening to this discussion today with Gubra. My name is Cailin McGurk. I'm a member of the investment banking team at Morgan Stanley.

Just before we get started, like other sessions at our conference there are some important disclosures for which you'll need to refer to the Morgan Stanley disclosure research website www.morganstanley.com/researchdisclosures. And if you have any further questions please reach out to your Morgan Stanley sales representative. I'm not sure how much outreach we get on the disclosures, but just for good measure.

So, Markus, it's a pleasure to have, not Gubra for the first time, but you for the first time attending our conference in New York. We were just discussing, it's effectively your 1-year anniversary at Gubra. You know, maybe, and we'll talk a little bit about who Gubra is today, but maybe just 1 or 2 minutes on your background, what attracted you to join this company? And then we've got lots of interesting topics to cover.

Well, thank you very much for inviting me, Cailin. It's a real pleasure to be here. I have a research background. I'm a scientist, a structural biologist. I spent many years in pharmaceutical research and management, more recently more in the biotech environment before I joined Gubra. What attracted me to Gubra was essentially seeing a unique opportunity to grow a company forward. Gubra has tremendous potential, and it's about realizing this potential and also with a great team and a great board, so I got immediately attracted to the opportunity and after 12 months I can really say Gubra is a unique place.

And it is a unique company and for those listening who may be a little bit more or less familiar, how would you describe Gubra today in terms of, you know, what the company, who you are, what your core competencies are, and as you joined and were excited about the opportunity, where you see the most potential value creation going forward?

Yes, in a simple concept, Gubra is a clinical stage bioscience company with a unique business model. We have 3 units; a biotech unit which discovers and develops novel peptide therapeutics to clinical proof of concept. At this stage, we would partner those assets with pharmaceutical companies. Our discovery platform is validated. We have multiple assets in the clinic. Our partnership and business model is validated based on the series of partnership deals the company has done.

On top of this, we have a very successful CRO serving external customers, but being an integral part of our innovation platform. And on top of that, we now have a new unit, Gubra Ventures, which enables us to invest our capabilities into high quality science adjacent to our core therapeutic areas. So overall, I see the vast majority of value growth in the biotech pipeline and that is also our focus.

We've had a couple of your partners also attending our conference. And for those that are less familiar, you've been very successful in terms of the early development and collaborations that you've struck on the obesity side. You now have 2 Phase II assets with 2 very, well-known and well-respected companies being AbbVie and obviously Boehringer Ingelheim. What does that tell you, the audience and us, about Gubra's competence and capabilities. And we'll start in the obesity field because that's obviously very large and important. And certainly you've seen 2 of these programs announced to progress in the very recent months.

Yes, I think I can talk a little bit about how the obesity market is developing and how this is reflected in our pipeline. So the obesity market has grown tremendously, and the field has advanced tremendously. Initially, it was about demonstrating a clinically reasonable loss of weight, how much weight can you lose in a period of time. Now it's more about complementary and additional mode of action which has the promise to deliver additional efficacy, tolerability, or also benefits to particular patient populations. There is additional focus on body composition and muscle health outcomes. And we also believe that combination therapy will be very important to deliver specific to the needs of certain patient populations. So -- and if you look at those 3 areas, I think that is clearly reflected in our current pipeline with the GGY triple partnered with Boehringer, with the amylin partnered with AbbVie, and also our own use of GUB-UCN2, the long-acting urocortin-2 agonist.

And we want to cover all 3 of those. Maybe we'll start because AbbVie recently announced their intention to progress. It's now called ABBV-295. It had a different name when I remember when you did the deal, they've signaled that they're moving that forward. It's an Amylin as you will go into, as you talked about your view on the evolution of the obesity treatment paradigm, what role do you foresee or Amylin broadly and then obviously ABBV-295? And then after that we'll talk about some of the next steps and updates from your partner on that program.

Yes, great. I think for the class, the Amylin class has already shown promising clinical efficacy. I see a favorable tolerability and safety profile and potentially also an opportunity for a more longer treatment cycles, right? So, I think if I look now at ABBV-295 particularly, we have seen great Phase I data, top line data this year, where the compound demonstrated about 10% weight loss in a period of 12 to 13 weeks, and taking a look at the patient population, which was like 88% male and also with a BMI on average around 30, this is actually very meaningful weight loss data and I think that is very, very promising. And on top of that, the compound achieved similar weight loss, with biweekly or monthly administration. So I think it's maybe -- it's going to be a great profile.

And there's some important next steps there on ABBV-295, I think they've talked about presentation at EASD. Relative to the data that's been put out into the public domain, is there anything that you can share in terms of what that update may be, what that patient population may look like relative to the data from earlier this year?

Yes. I think we have seen the top line data. There will be a fuller data set. We get nuances on efficacy and also on the safety and tolerability profile. So that will be important to understand the drug in the full context of this trial. On top of that, there is a Phase Ib trial is running in the U.S. in a more representative study population with BMI between 30 and 45. There's also a much larger portion of female study participants. And this trial runs a little bit longer, 20 weeks. So I think that was going to be a very important data set to inform further development of the drug on top of, of course, the ongoing Phase II trial. But I think taking together those 2 trials that will give us a good indication on how this particular compound will translate into clinical efficacy and safety.

And maybe one more last question on ABBV-295. Obviously, with the very intriguing data that has come out in relation to the broader amylin class, there's some debates about JAK versus selective. Where do you, based on the work that you had done at Gubra, think that the collaboration that you have with AbbVie has the potential to differentiate versus other approaches that are out there?

Yes. I think at the moment, that will be speculation, right? And I probably want to go -- I don't want to go there. What we know for sure is that we have a very long-acting molecule with proven efficacy. And I think the ongoing trials will definitely show what the profile of the drug will be.

Should we maybe change tack to the other Phase II program that you have with one of your partners, Boehringer Ingelheim in the era and with all of the excitement about triples, this is also a triple, but a slightly different triple. So maybe talk about the sort of target selection there and the NPY2 biology?

Yes. So a different triple, but equally exciting. So the concept behind this triple is basically to combine the well-established incretin biology with the central regulator of food intake NPY2. And taken together, you double down on food intake and that should provide the basis -- the fundamental basis to demonstrate deeper and more durable weight loss. So that's basically the concept behind it. And Phase II has now started. And so hopefully, this exciting complementary mechanism will show great clinical efficacy and safety and will give us an indication on the positioning of the drug.

More importantly or as importantly, moving on to your third, you probably have more, but at least the next most advanced obesity program at Gubra, which is against a very exciting new target area of biology, which is UCN2. So you've made great progress here. I think there's -- we've seen some transaction activity very recently in the UCN2 space. What makes you excited about the [ target ] and maybe link that back to some of the trends that you foresee in obesity and where the remaining unmet need is?

So our long-acting urocortin-2 agonist has an exciting biology. Preservation of muscle and muscle health is becoming a more important topic. If you substantially lose weight, you not only lose fat mass, but you also lose lean mass and a part of that is skeletal muscle. Skeletal muscle is very important, and it is a determinant of physical function, mobility and metabolic health. And also for the elderly population, the maintenance of muscle mass and function is super critical to live a healthy life. So I think this is exactly where UCN2 comes in. In preclinical studies, we have demonstrated substantial additional reduction of fat mass. And at the same time, UCN2 prevents the loss of lean mass and even to some extent, increases lean body mass.

So I think this is a very promising profile. And in our ongoing Phase I/IIa trial, we are really looking at this in a comprehensive way to explore the biology, both as a mono compound, but also in combination with incretin-based therapies for maximum impact for patients in different populations. So the trial is quite exciting. It has 3 parts. We start with classical SAD trial in a healthy population, followed by an MAD trial in obese patients for 6 weeks of treatment with multiple doses. And then the third part where we have 16 weeks of treatment with multiple doses as a monotherapy and in combination. So the overall package on Phase IIa study plus our preclinical evidence in totality will be a very rich data set. So we are very excited about this compound.

Now moving into obesity is sort of the clear first step. But we believe there is substantially more potential beyond obesity in areas where muscle health and muscle function is important. So it will also have a substantial commercial potential. So that's an exciting area for us where we will invest significantly going forward. I think you mentioned the recent deal between Genentech and Hanmi. Obviously, that is very exciting to see because it validates the potential of the biology and a first pharma company has made a strategic move into the field. We, of course, welcome additional science in the field. We are among the front runners on the UCN2 biology. And I mean, we as a company, we have made a deliberate decision not to partner UCN2 and to complete our Phase IIa program to maximize the potential of the asset for Gubra when we partnered.

One last question, and we'll move on to some of the other business areas outside of weight management and obesity. Perhaps it's still early days. As you say, you've seen validation of the approach, the recent deal between Hanmi and Genentech. As you sort of scan the competitive landscape for urocortin-2, do you think there is likely to be differences as we've seen in the sort of GLP-1 space or more similar than different, and it's going to boil down to the quality of the package and the quality of the development or possibly just too soon to tell?

Yes, it's a little bit too soon because there's no clinical data published on any of those compounds. I think the field is getting more competitive as more people realize the value of the biology. I think we certainly have focused on the quality of our package. And I think this is how -- for Gubra at least, that is the best way to deliver high quality to potential partners.

Moving on maybe to just sort of more broadly where Gubra sort of sees the opportunity from a development standpoint, your legacy and sort of strength has clearly been in weight management, metabolic disease, clearly validated by the partners that you've attracted. But I think you're increasingly talking about the potential and the interest of Gubra as being more agnostic around therapy area. What -- how should we sort of think about your intention or ambitions to move out of obesity into other areas?

Yes, that's a good question. I think over almost 20 years, Gubra has built tremendous experience in metabolic diseases and obesity. So there is no question that this is an important area for us and also will continue to be an important area for us. Having said this, our streaMLine discovery platform, our translational capabilities and clinical capabilities are relatively disease agnostic. So we can enter in spaces where peptides have high value beyond obesity as well. Of course, we will look at this selectively, and it will be capability-led, right? But we certainly have the capabilities to enter in other disease areas. And that is one aspect we will also cover in our upcoming R&D Day on October 27 in London.

And I'll come back to that just so we can dig into at the end, what's the full agenda that we can expect at that event will be. Maybe moving on to the CRO business. This was part of the foundation of the company, has been an incredibly important and successful business for you historically. But I guess in the context of today's environment with some of the headwinds we had faced from a budgetary and sort of broader spend standpoint, what is your perspective on the environment in which your CRO business is operating today?

Yes. The CRO unit has been very successful. Over the last 10 years, the CRO has delivered about 14% average growth every year, which is quite impressive. We are very specialized in metabolic models where we have gold standards in different aspects of metabolic disease. In the last 12 to 18 months, the CRO market was relatively challenging, and we have seen that directly in 2025, for example. Over the last 6 months, we have seen 11% revenue growth compared to the previous 6 months. So I think I'm quite confident that revenue will continue to grow, profitability will stabilize. So -- and our order book makes me confident about the overall aspiration for the year.

Long term, I think this will remain a very attractive business part. The pharma companies tend to outsource early preclinical work substantially and focus on areas where they can deliver -- focus on and deliver more value. So I believe this will be a market which will continue to grow and where we can compete with our innovative in vivo models very well. So -- but aside from the CRO being a successful commercial unit of Gubra, I really value the strategic aspect of the CRO as it relates to our innovation model and also into developing drugs because only -- because the CRO has the relevant in vivo models today, we can develop drugs from sort of a peptide backbone towards a drug development candidate in approximately 18 months, which is very competitive. So I see the combination of the CRO and the biotech business and the future ventures actually as very synergistic, and it's part of our unique model differentiating us from other biotech companies.

That sort of largely answered my last question on CRO, which was -- this is clearly a very different business from proprietary biotech or proprietary pipeline development. But I think what you were saying is the capabilities and the competency and the expertise is both incredibly important, but also synergistic with the broader business. And when you -- in the first couple of minutes, you sort of talked about the expansion into ventures and your ability to look externally as well as internally for future innovation. Talk a little bit for those who are less familiar about Gubra Ventures. What is the strategy? How do you look to create value? And what types of opportunities are going to be most relevant and most interesting for you going forward?

Yes. So again, Gubra Ventures is an opportunity to invest our capabilities in assets adjacent to our core areas. I think this will give us additional opportunity and to basically leverage what we have today as capabilities at the scale, which in the past, we were not able to do. And we can use this in a collaboration model with strategic and financial investors to quickly advance assets into clinical proof of concept and then long-term share economics on those assets. We are particularly interested in assets with exciting translational biology. So we can design really clinical trials, which are truly clinical proof of concept. So that is important.

And it is also important that we, as Gubra can add more than just capital to those ventures so that our preclinical and translational biology expertise can be fully leveraged. We will talk a little bit more about what we are currently focusing on and how the interaction between the units and the ventures will work at the R&D Day. But essentially, at the moment, we are building an opportunity funnel. We have not necessarily set a specific point where we will do the first venture, but it is important that it's the right quality of venture and that we do the right first deal for Gubra where we can add most value and also generate additional value for the company in the long run.

And any hints or insights into when we might be able to share some specific news or something more tangible in terms of what you've been up to at Gubra Ventures?

Yes, my lips are sealed.

Okay. Maybe October will come back by next year, definitely. Perfect. As you think about -- I think we've covered the out-licensed programs with your partners, your proprietary -- key proprietary program, UCN2, we haven't talked about everything there, Ventures, CRO. How do you sort of think about the optimal configuration between clearly having the ability to secure very attractive partners with the financial and other expertise to drive development versus continuing on your own and sort of developing your own pipeline further. You did allude to this when we were talking about UCN2 and the sort of clear intention and desire to progress that forward. How far do you want to go? Is this UCN2 specific case by case? How are you just thinking about that as you build your own pipeline going forward?

Yes. I think that's a very good question. The partnership model is working very well for Gubra and we have been able to capture substantial value for our partner programs. And that is the right business model for Gubra today. I mean what has changed in -- recently is that we have a better financial foundation that we have more expertise in clinical -- early clinical development. So we can decide on how long or how far do we push our own development versus partnering early, and we will do that based on our portfolio considerations, risk considerations, capital allocation and also what a potential partner can bring in.

Today, we have the option to be more driven towards and keeping some of the high-value assets longer. And UCN2 is a great example because we are investing towards a Phase IIb-ready asset to be partnered, right? It's very different from other deals we have done. And I think it will probably not be for every asset. And for some assets may be that it is actually good to partner a little bit early, but we will look at this in an asset-by-asset decision for sure. But we will focus on what we are good at. We are good at discovering drugs, doing the translational biology and moving assets towards clinical proof of concept.

And in our model, our partners bring in the late-stage development expertise, the commercial expertise, and we profit from those partnerships with long-term economics, which we are really investing into our portfolio. And I think that's a model which is working for Gubra today and will also be working for Gubra in the coming years. The difference will be that we try to capture as much value as possible by keeping some assets a little bit longer.

One last question on that, and then I do want to talk about what we're going to see over the next 12 to 18 months and maybe wrap up on your upcoming investor R&D event. I had the privilege of hosting another one of your collaboration partners yesterday, where you've done much earlier sort of scientific collaborations, which was with the team at Amylyx. I guess for these earlier-stage discovery type collaborations, will those remain interesting more on a case-by-case basis? Or how are you thinking about those going forward?

Yes. First, let me say that the Amylyx deal team are fantastic collaborators. We love to work with them, and they are great people and the collaboration is spectacular actually. So, in principle, the highest value which we can generate is to focus on proprietary assets and bring them forward. However, where there is a scientific synergy and where we believe we can add additional value and we can learn something, those type of scientific collaborations will always be an opportunity for Gubra, and all sorts of interesting things develop out of those collaborations. So I think they have a place in our heart.

And I spoke equally highly of you as a collaboration partner during my session with them yesterday. Maybe just 2 topics in the last few minutes that we have. Over the next 12 to 18 months, obviously, we -- potentially plenty of news and updates from some of your partnered programs. But what should investors be most focused on in terms of news flow?

Yes. I expect quite some news flow in that period. I mean, of course, Central to us is GUB-UCN2 program. We will see the first data from the program, results from the SAD part of the trial, the safety, tolerability and PK data. We will start the MAD trial. So -- and maybe there's also some external data around urocortin-2 agonist. So that will also be supportive for the class. Then, on ABBV-295, certainly, the Phase Ib top line data, we would expect that within the first half of next year, that will be exciting. And I mean the fact that we now have 2 Phase II programs partnered and the successful continued development is already another validation that our compounds can reach late-stage development and hopefully soon commercialization.

So overall, I think investors may have looked at us a year ago in terms of, "Oh, it's a promising company, a unique business model, really interesting early compounds versus next year, hopefully, we'll see some exciting clinical evidence on our molecules." And I think that hopefully will show the value of the company and what we can deliver. Obviously, only as a team across. And I think Gubra has a great leadership team and all of our 300 Gubies are fantastic, our secret sauce.

Very good. And maybe just one last one. Hopefully, investors will have the opportunity to attend in person. You're going to hold an investor R&D event in London, 27th of October. I understand part of the agenda there will be to talk more specifically about your long-term strategy and ambitions towards the end of the decade in 2030. Clearly, you can't prewire everything and give all the good stuff away at our conference as much as we would love you to. But anything further to add in terms of what's going to be interesting and exciting in terms of the updates you provide there?

Yes. So it will be our first R&D Day. And I hope for investors, it will be exciting to hear some more tangible description of our long-term strategy. So that is correct. So we'll describe our strategy towards 2030. We'll talk a little bit about our discovery focus and elements of what we talked before also beyond obesity. We'll talk, of course, about GUB-UCN2 program, the trial and the potential we see on this biology. I will talk more about ventures and our CFO and our whole concept on capital allocation. So it will be hopefully exciting and informative for investors.

Very good. And the Morgan Stanley team will certainly be there. So look, Markus, with that, I'll wrap up. We're bang on time. Thank you so much for attending. I appreciate you and the team making the trip across from Europe as always, and very much forward looking -- looking forward to having you back next year. It's going to be an exciting 12 to 18 months and even more. So watch this space. Thank you very much.

Yes. Thank you, Cailin, for the invitation.

Welcome to the conference call. [Operator Instructions]

Now I will hand the conference over to the speakers. Please go ahead.

Good morning, everyone, and welcome to Gubra's conference call covering our first half 2026 results. My name is Adam, new Head of Investor Relations at Gubra. And joining me today are members of Gubra's leadership team, who will take you through key developments for the company in the first six months of 2026 and our financial results. Following the presentation, we will open the call for questions. Before we begin, I would just caution listeners on Slide 2 here that we may make forward-looking statements that are subject to risks and uncertainties. And with that, I will hand over the call to our CEO, Markus, for opening remarks.

Thank you very much, Adam. Good morning, everyone. Welcome also from my side to our webcast. I'd like to give a couple of highlights of the company. In summary, I believe Gubra had a very good first half of the year across our entire business units. Gubra Biotech significantly advanced our R&D pipeline. And in the CRO, I think while we still have work to do, I see a promising trend based on new commercial initiatives and also continued cost discipline. And we have also now established a platform for Gubra Ventures. This is a new business unit at Gubra, and we are currently evaluating multiple deals.

And over the next couple of months, I hope we can announce the first Gubra Venture. At this point, I'd like to remind you that our business model is unique based on three synergistic business units. Gubra Biotech discovers and develops new peptide therapeutics up to clinical proof of concept. Gubra Ventures invests in exciting science adjacent to our flagship areas and our CRO while serving many external customers is an integral and very important part of our innovation in the biotech unit as well in our new ventures.

Let me highlight a couple of milestones which already have been achieved in the first half of the year. I'm just going to mention 3 of them. AbbVie reported highly encouraging Phase I MAD results for the long-acting amylin. I think this is very robust data and the start of the Phase II is imminent. Boehringer Ingelheim has already advanced the triple agonist in clinical Phase II. And we now have initiated an ambitious Phase I/IIa trial for our fully owned GUB-UCN2 program, our new mega program. And with this, I'd like to hand over to Louise.

Yes. Thank you, Markus. So let's take a look at our StreaMLine platform and how it enables our growing pipeline. So Gubra, we're true experts in peptide drug discovery. And our core edge is that all the work we do is done using an in-house developed drug discovery platform, StreaMLine. And the platform takes advantage of [Technical Difficulty] analysis, and this is combined with high throughput wet lab screening of multiple peptide libraries. So we use multiparameter optimization. So what this means is that we optimize all key drug properties at once. So ultimately, this enables us to save time and identify better molecules at speed.

So the StreaMLine platform has repeatedly delivered differentiated assets across a variety of therapeutic areas. So what you see here is the Gubra R&D pipeline. And since the last update, we have seen important progress. First of all, we have seen the initiation of a UCN2 program entering Phase I. Additionally, Boehringer Ingelheim has initiated Phase II development with the triple agonist and AbbVie still plans to initiate Phase II in Q3. Simultaneously, Hemab has expressed that they expect to initiate first-in-human trials with HMB-003 in the second half of '26.

And likewise, we have concluded the fourth collaboration project with Boehringer Ingelheim, a very early target discovery program. So at Gubra, we have been dedicated to treating and understanding obesity since the company's inception. And over the years, we have generated deep scientific expertise all the way from discovery to clinical translation. And today, we'll take a look at 3 of our most advanced anti-obesity assets, so they are each designed with a differentiated profile compared to current standard of care and with blockbuster potential.

But before getting into the data, let's just take a step back and take a broader look at the obesity landscape and where the market is heading because it's no secret that obesity continues to be a growing global health care challenge and there is a well-recognized need for novel treatment approaches. And for the past decades, the core question with obesity treatment has really been, can we make patients lose weight? Can we achieve clinically meaningful weight loss? And this has been the focus of the first wave and has really been spearheaded by the first generation of incretin-based treatment.

The focus on the current wave has been to maximize body weight reduction and improve tolerability. Here, we've seen the introduction of complementary and alternative mode of actions. We've seen the introduction of amylin analog as well as multimodal therapies, including dual and triple agonist. And the toolbox for patients have been significantly expanded here. But it's also well acknowledged that the body weight reduction is not just fat mass. Lean mass actually accounts for 20% to 45% of the weight loss. And lean mass, it's muscle, its bones, it's internal organs.

So it's all the tissue that we would ideally like to preserve when we are trying to lose weight. Therefore, we believe that the focus for the next wave will be quality with focus on body composition, maximizing fat mass loss and preserve or even enhance skeletal muscle mass. That's where the field is going. And Gubra's pipeline is strategically positioned to meet these emerging trends. So now let's take a look at some of these assets. First of all, we have the triple agonist, long-acting first-in-class. This asset targets the GLP-1, GIP and Y2 receptors to engage in complementary mode of action involved in body weight reduction.

This asset was discovered in collaboration with Boehringer Ingelheim, who now has sole responsibility for driving it forward. And after seeing encouraging Phase I data that demonstrated a favorable safety and tolerability profile along with encouraging weight loss, Boehringer Ingelheim has now initiated the Phase II in development yet. The study will enroll approximately 300 participants that are treated for 42 weeks. So we really see this as a true validation of both the assets' potential, but also Gubra's peptide discovery capabilities. So next, we have ABBV-295, the long-acting amylin analog that is now out-licensed to AbbVie. A core differentiator with the amylin class of compounds is the potential to deliver clinically relevant weight loss with a better tolerability profile.

So this means that amylin may represent the next distinct class of drugs for chronic weight management. ABBV-295 has consistently shown competitive results throughout a comprehensive Phase I program. The data from the MAD study was top line data was presented by AbbVie in March and here ABBV-295 showed a very competitive weight loss profile of almost 10% after just 12 weeks of treatment. And remember that this is in a lower BMI cohort with predominantly male participants. Importantly, ABBV-295 also revealed the potential for less frequent dosing.

So here, comparable weight loss was observed with every second weekly dosing or even once monthly dosing. In addition, ABBV-295 had a favorable safety and tolerability profile, adverse events were predominantly GI mild and transient. So the data from this study will be presented at EASD in September. Currently, ABBV-295 is being tested in an ongoing Phase Ib trial in people with obesity, higher BMI range and higher proportion of female participants and AbbVie still plans to initiate Phase II in Q3. And with that, I'm happy to hand over to Thomas, our CDMO (sic) [ CMDO ], who will talk more about our UCN2 program.

Thank you, Louise. So now let me turn to what makes GUB-UCN2 so compelling. So GUB-UCN2 is a long-acting agonist at the CRHR2 receptor. And that makes it really a very differentiated and novel mechanism of action that addresses key needs for people living with obesity. And as you can see on this slide, in adipose tissue, UCN2 lowers fat mass and lowers triglycerides. In the muscle tissue, which is actually the main tissue, the main target tissue for UCN2, it drives the buildup of muscle through anabolic and inhibition of catabolic effect, which also has a positive impact on insulin sensitivity.

And further evidence really points towards additional cardiorenal benefits as laid out on the slide. For me, there are actually 2 key takeaways on that slide. First, GUB-UCN2 is not really simply about weight loss. It really has the potential to fundamentally improve body composition by reduction of fat mass and by building muscle mass at the same time. The added muscle mass is really expected to provide a functional benefit to patients through improvement of strength and physical performance. And that really opens up two really compelling and attractive development path.

On one hand, using GUB-UCN2 as a differentiated monotherapy on the other hand, in conjunction with incretin-based therapies. The second key takeaway is that the opportunity is not about obesity alone. As I indicated, we have multiple effects on very differentiated tissues, which gives us the opportunity to develop GUB-UCN2 into multiple indications, in particular, if you are thinking about muscle wasting conditions and cardiorenal diseases, which gives GUB-UCN2 really a very broad development potential. So the preclinical data generated to date make the potential really tangible.

So I would like to share a data set with you really as an example of the use case for GUB-UCN2, where we investigated it as monotherapy and in combination with semaglutide in rats with obesity due to high fat diet. On the left-hand side, you can see that GUB-UCN2 really profoundly reduces fat mass, which is depicted by the green bar. When combined with semaglutide, we do see an additive effect beyond the effect that we do see with either treatment alone. The middle graph shows really the differentiation of GUB-UCN2. We do see that with this mechanism of action; we can really build lean mass of which muscle is really a predominant part.

And we can also rescue the loss of muscle mass that we see with semaglutide in this experimental setting. On the right-hand side, you see actually very nicely why body weight does not tell the full story. Monotherapy alone does not result in a reduction in body weight in this particular experimental setting. And that is because we reduce body fat and at the same time, balance it with a gain in muscle mass. Hence, the overall effect in this setting is neutral.

However, when combined with semaglutide, we continue seeing the weight reduction driven by semaglutide, but GUB-UCN2 really dramatically changes the composition of the weight loss that we are seeing in combination therapy. This is really a very, very attractive drug profile, right, reducing fat mass improving muscle mass and having the potential for a functional muscle improvement. So we are very excited about now moving this asset into clinical development.

And it's really an important inflection point for Gubra, right, moving a compelling preclinical package into a clinical opportunity. We have now initiated a very comprehensive Phase I/IIa clinical trial where we enroll healthy participants, but also people living with obesity and move the assessment from the single ascending dose to a multiple ascending dose and a multiple dose part with up to 16 weeks of treatment duration. Importantly, we are assessing GUB-UCN2 as monotherapy and as combination therapy with an incretin.

So in addition to the typical Phase I endpoints related to safety, tolerability and pharmacokinetics, the trial was really designed from the outset to provide a very comprehensive clinical data package looking at muscle mass and muscle function and also building the foundation really for indication expansion into muscle-wasting conditions and into cardiorenal diseases. So we will be able to speak more about the development program of GUB-UCN2 at our upcoming R&D event on October 27. So with that, I would like to conclude and hand it over to Zoë, our Head of Gubra Ventures.

Thank you, Thomas. So now we turn to Gubra Ventures, which is our value accelerator. And the message here is simple. We are using our internal engine to create additional routes to value via external innovation. So why are we doing this? Well, Gubra Ventures is built around four value accelerators. The first is increasing shots on goal by accessing external innovation, including novel assets and novel technologies that are complementary to Gubra's core. The second is expansion into new diseases and new technology areas.

The third is return via future exits for additional revenue stream beyond that of the CRO and the biotech pipeline. And the fourth is because this will not be a standing start so we can go faster, we can lower our dependencies on external service providers, and we can also use disciplined capital use to create these opportunities.

And why now? Well, Gubra is really uniquely positioned to build on the credible foundations that we've built and amplify those to produce these value accelerators. So the first foundation is our scientific and therapeutic area depth as well as our development capabilities. Secondly, we have a discovery platform that we can use for joint ventures to create new opportunities in the peptide therapeutic space.

And third, we'll use our integrated capabilities, know-how and shared infrastructure to bring those opportunities faster to the clinic. So in all these respects, Gubra will be bringing -- Gubra Ventures will be bringing more than capital. So in summary, we're expanding our innovation footprint by additional routes to return and turning what we do well into further value creation. And with that, I'll pass over to Trine.

Thank you so much for that, Zoë. The CRO is continuously an important value enabler for Gubra. For many years, we've had a strong record of solid growth and profitability, building best-in-class services for serving our customers, both externally and internally. We are considered a scientific leader. We have more than 18 years' experience working in the metabolic space and in particular, in obesity, and we serve 17 of top 20 pharmas globally. They really chose us because we can deliver complex models with high-quality, unbiased data at speed and with excellent scientific guidance.

So our ambition is really to stay ahead of the curve. We've done that always in the past, introducing obesity services very early on, MASH and kidney platforms. And now we're introducing -- we have introduced this year services in women's health and Sarcopenia, so this muscle platform and really trying to differentiate ourselves and open up new growth opportunities for the future. So it's this combination of deep scientific expertise and the trusted customer relationship and continuous service innovation that underpins the long-term strength of the CRO business.

After a few challenging quarters, we are seeing early signs of improvement across a number of different market indicators. In particular, biotech funding has rebounded strongly in 2026. And we also see a continued outsourcing trend among pharma companies, especially. And this is really driving demand in our industry. We have clear priorities. We want to maintain our leading position in the metabolic and fibrotic space. We want to also, as I said, expand into new interesting and attractive therapeutic areas and accelerate the development of the commercialization of our advanced 2D and 3D imaging platforms.

Besides that, we are also increasing our commercial activities, in particular, in U.S., we are expanding and combining this with a cost discipline, we really focus on regaining momentum. We've grown 11% since first -- second half of 2025. And we've also returned to positive profitability. So this is -- there's naturally some uncertainty around the revenue recognition, but we see a very sound order book, both with our external and internal customers.

Obesity remains our largest contributor revenue-wise, and we see a rebound in MASH and kidney studies, which is improving the commercial outlook for the second half of the year. So overall, we see -- we are cautiously optimistic about the next half year, and we want to convert this momentum that we're having now into profitable growth while continuing to strengthen the strategic importance of the CRO for that business. And now I will hand it over to you, Kristian.

Thank you, Trine. And just a little bit of clarification on the recognition of revenue. It is not uncertain that we recognize revenue. It's just when we sell in the CRO business, revenue will occur when we perform the studies, not uncertainty just if we recognize revenue. Just as a clarification. So with that, let's look at the financials, right, taking the Biotech business first. So this is a business that naturally has lumpiness in its revenue and earnings when upfront payment -- upstream upfront payments occur and when milestone payments occur.

And -- in the first half of '26, we had some milestone payments, but totaling DKK 30 million, but not, of course, to the same level as last year where we had the upfront payment from AbbVie of DKK 2.4 billion. So this lumpiness occurs each and every quarter as inherently in a Biotech business with partnership collaborations. And we know already in Q3, we will receive EUR 10 million from start-up of the Phase II for the triple agonist from Boehringer. So a very important payment that will -- that is already recognized in the books for Q3.

Taking the CRO business, as Trine said, we have seen a sequential improvement with revenue up 11% compared to the second half of last year. And as Trine also said, we're seeing an overall stronger demand situation, especially for our smaller clients. And the smaller clients are typically the swing factor in Gubra's earnings and revenue in the CRO business. Just as you saw in '23 and '24, there was a lot of influx of smaller clients in Gubra and a bit of the opposite in '25. And that has been to a large extent driven by the funding conditions and funding conditions are now improving. So we're looking into a quite sound order book for second half of '26.

Earnings, Q4, we had a small loss, and now we turned that into a small profit in first half. And we expect relatively sound earnings in the second half of this year. That brings me into the outlook. So short message, unchanged outlook for '26. Starting with the Biotech business, just as a reminder, we only guide on total cost. That means both internal costs and external costs for clinical trials, for example. And there we guide DKK 330 million to DKK 360 million. CRO business revenue growth, we expect growth in the range of 0% to 10% and an EBIT margin in the range of 10% to 15%.

So again, unchanged compared to the guidance we have provided earlier -- unchanged guidance also for the smaller business units, Ventures and Gubra Green. With that, I give the word over to Markus to speak a bit about the news flow going forward here. Please, Markus.

Thank you very much, Kristian. I'd like to end with the next value inflection points for Gubra, and I believe we are entering an exciting period of growth. The next important milestone for us is the start of Phase II for the long-acting amylin. And I think this is imminent. So there will be good news coming soon. And there will also more details be published about this molecule and the Phase I MAD study coming up. And looking forward in terms of clinical milestones in the first half of 2027, that will be exciting news as well. We have top line data for UCN2 in terms of the first part of the trial, the SAD part. We will initiate the second part, the MAD part. And what is also exciting is the Phase Ib top line data for ABBV-295.

I want to point out that this is in patients with -- which are truly obese up to BMI of 45 and with a higher female participation. So I think this will be exciting data. And out of our previously mentioned research collaborations with Hemab, also the first compound will enter first in human studies. On top of that, we will announce our first venture and I'm confident that we will see rejuvenated growth out of the CRO as well. So taken together all those already achieved milestones and our confident outlook, we have all good reasons to be ambitious about the second half of the year, but also for the future of the company.

And I'm equally excited to tell you more about our growth strategy at our Gubra Investor R&D event on October 27 in London. I will talk about the growth strategy, our ambitious growth strategy. We will talk about our pipeline, give some updates. We will present our UCN2 development strategy, its potential indications and other elements of our strategy. So please join us at the webcast or hopefully in person. It will certainly be an exciting day, and I'm looking forward to the presentation.

Good. Thanks a lot, Markus, and thank you to all our presenters as well. That takes us to the Q&A session. So operator, we are ready to take the first set of questions.

[Operator Instructions]

The next question comes from Thomas Bowers from SEB.

A few questions from my side here. So maybe just on UCN2. So the trial is now listed on ClinicalTrials. And I note that there's only one center now recruiting patients. So should we expect this to be a multicenter study? And how about the U.S. side? Should we expect that to come online at some point in time if you're planning for more here? And then secondly, also on UCN2, maybe just clarification on the primary efficacy endpoint here for the MAD part MAD on -- of the Phase I/IIa. So -- so are you primarily looking at type 2 diabetes-related muscle loss, maybe also obesity once you combine with the incretin to get this early signal?

Or should we also expect you to have data from potential cardiorenal patients with cardiorenal comorbidities? And then lastly, on UCN2, just to understand the incretin part, the combination here. Are you looking to sort of mirror the standard incretin titration? Or are you may be aiming to just go with a fixed low-dose incretin and then use that on top of the UCN2 titration? I'm a little bit curious on how you actually plan to combine this initially. And then my last question, just on the CRO business. So you're expecting a recovery in second half. Are this also reflecting that we could maybe come back to expecting double-digit growth beyond '26?

Thanks a lot for those questions, Thomas. So I think the first 3 questions on UCN2, clinical trial site, single center versus multicenter and some trial design specific questions, we will go to Thomas. And then afterwards, a question on the CRO business, we'll go to Trine. But Thomas, on UCN2.

Yes, I'm happy to take the questions on UCN2. Thank you for that, Thomas. So with regards to the clinical trial site, we have deliberately selected one site for the current trial. And the reason for that is that we have really complex endpoints, right, around muscle function, muscle volume that really requires expertise at the site. We currently do not plan to expand beyond the site, but we will see how the trial is going to progress.

With regards to the overall development strategy and details to the clinical trial, Thomas, we will certainly provide an update at the October 27 R&D Day. But to address some of your points, we are certainly very interested in understanding how UCN2 performs both as a monotherapy and in conjunction with incretin therapy for the combination arms, we will certainly utilize commercialized products at the prescribed dosing regimens. I think that addresses the questions or did I forget?

I think you covered it all. And then the last question was on CRO expectations for second half of the year. And if there's anything we can say on getting back to double-digit growth.

So as I said, we see a positive trend in the market, and we expect to be able to follow guidance in the second half of 2026. Looking into '27, what we have been working on in 2026 is expanding our model portfolio to stand and be ahead of the curve on important growth areas relevant in the market, combined with our cost discipline and the initiatives we have taken on that side. So in '27, I am -- my hope is to get back to the long-term guidance, which is 10% growth. This is our ambition.

Just supplementing Trine. So the Gubra CRO business is a growth case. We've grown over the years by around 14% over the last couple of years, 14% annually. So -- but of course, there are some swings between certain years, but definitely, Gubra CRO is in a good position and there -- we want to grow the business 10% annually.

So we are now ready for the next question.

The next question comes from Rajan Sharma from Goldman Sachs.

I've got 2, one on the CRO and one on the Biotech business. Maybe just starting with UCN2. Could you just help us understand what are the most important endpoints that you'll be monitoring to support that target product profile there? What's your internal bar for success? And what would you need to see to justify further development for that asset when we see the data next year?

And then just on the CRO, I think obviously, you talked about expanding into women's health. Could you just give us an update on progress there in development? Just looking on your comments on Slide 23, it doesn't look like women's health is contributing commercially this year. When should we start to expect some contribution?

Good. Okay. Thanks a lot, Rajan. So let's start again with UCN2. Anything in addition that we can add on endpoints and what could justify progression from SAD part into the subsequent parts of the trial. We'll go to Thomas.

Yes. Rajan, we will generate data in this trial sequentially. In the SAD trial, we expect results on safety, tolerability and pharmacokinetics that would help us to determine how and which dose levels to move forward in the multiple ascending dose and in the multiple dose part of the trial. So we will start off with generating this data set and then continue generating endpoints around early efficacy readouts in the subsequent parts of the trial.

And as I indicated earlier, these will be measurements around body composition that really helps us to understand how much fat loss and muscle gain we can generate with this mechanism of action and whether that really translates into a functional muscle benefit, which would be important for us as success criteria.

The second question on CRO and the new therapeutic areas, women's health and Sarcopenia, any color we can add on contributions?

So the question was really to revenue from the women's health area. And there's a huge unmet medical need in the women's health area. And as I said before, we always really strive to be ahead of the curve in terms of developing our services and being ready for demand. And of course, women's health is an opportunistic on our side, but we really want to be ready when investment starts floating into this area. There's an unmet need. We have the capabilities to succeed also due to our advanced both model capabilities and 3D, 2D and 3D imaging capabilities.

So we're well positioned in this space also with the metabolic background that we have. But of course, it does take some time sometimes to build this market. On the muscle platform in Sarcopenia, we've seen actually a lot of traction already, and it's a service that we've just launched this year and in particular, from our internal customer at Gubra, we are seeing a high demand and also from external customers. But -- so here, the trajectory is faster. So -- but thank you for the question.

Good. Thanks a lot. Thanks a lot Trine, Thanks a lot Thomas, thank you for the question, Rajan. We are ready for the next set of questions.

The next question comes from Suzanne van Voorthuizen from Kempen.

This is Romy on for Suzanne. Just another follow-up on UCN2. So you highlight several potential indication expansion opportunities beyond obesity. So we're just wondering what specifically from the study next year will determine prioritizations next? And how soon can we expect this?

Right. I think that question goes to Thomas as well, indication expansion opportunities.

Yes. Suzanne, maybe 2 thoughts related to that. Number one, we are continuing to work on our preclinical profiling plan along with collecting the related cardiorenal endpoints in the ongoing clinical trial. And that in conjunction, will really help us to determine in which direction we'll drive the further development of UCN2. So we will be looking at cardiorenal endpoints also in the multiple dose part of the trial. That is a data set that will not be available at the beginning, but at the end of the trial.

Thanks a lot, Thomas. And currently, we do not see any additional questions from the audio platform. We have one question in writing here. So that relates to potential ex-dividend date in 2026. So I think the question is around whether we should expect a recurring dividend from Gubra, perhaps CFO, Kristian can address that.

Yes. We had a very pleasant situation last year where we announced an extraordinary dividend, a bit unusual for a biotech company. So remember, that was an extraordinary dividend on the back of the upfront payment for the amylin assets. And we have not declared dividends for this year. So yes, effectively, we don't pay out dividend in '26. And going forward, we will announce whether there will be a dividend or not. Again, remember, Gubra is a biotech company, and you should not expect recurring dividend each and every year.

Very good. Thanks a lot, Kristian. And thanks to everyone for attending and for the many questions. Thanks a lot. That concludes today's call. Yes, we look very much forward to connecting with many of you over the coming weeks and months and have a great day.

Welcome to the conference call. [Operator Instructions]. Now I will hand the conference over to the speakers. Please go ahead.

Good morning, everybody. Welcome to our Q1 investor call. I will go through a couple of highlights of the first quarter and then hand over to the team to continue. A quick reminder, Gubra operates via a business model involving 3 distinct but synergistic business units. We have our biotech unit where we discover and develop peptide therapeutics, and we have a validated platform with multiple obesity assets in clinical development. We have our CRO where we provide preclinical research services to external and internal customers. And we have also now established Gubra Ventures, where we invest in high-quality science adjacent to our core areas.

Given I've recently received questions, I also want to be clear that Gubra Ventures is not a corporate venture fund. Coming out a record year 2025. We have started 2026 with great momentum in our biotech pipeline. A few recent events. In the beginning of the year, we have started to expand our facilities here in Boston at the DTU Science Park. So we are significantly expanding our lab facilities, which is beneficial to our internal discovery group as well as our CRO that we can do more studies in the future. We have strengthened our clinical leadership with the recruitment of Thomas. Thomas is our Chief Development and Medical Officer. And given we will focus on clinical development of multiple assets in parallel in the future, this is an important step for the company.

We have also progressed on partner programs like Amylyx has selected a drug development candidate and is moving into IND-enabling studies. That's good news. We have also launched Gubra Ventures and Zoe Johnson has started in March to drive this forward. And in terms of our clinical pipeline, we have submitted GUB-UCN2 clinical trial application for an ambitious Phase I/IIa trial. And this is very exciting. This asset is a major opportunity for the company. On our partnered asset, there is also a great progress. AbbVie released ABBV-295 Phase I MAD data, 10% weight loss within 12 weeks in predominantly male and non-obese populations is actually very, very promising, and you will hear more about that later in the call.

In last week also announced that the triple agonist will move into Phase II by mid of the year. And also AbbVie will proceed with the 295 Phase II in Q3 2026. So this is quite exciting. We will have 2 discovered assets in Phase II this year and also starting the Phase I trial for UCN2. So great momentum in the biotech pipeline. This is our leadership team. You have seen most of them already. And on the lower panel, you see [ Thomas ] who has joined us in the first quarter. So in March, Grigo in February and Thomas in January. We will not talk about our upgrade of digital strategy, but this may be a topic for the future. But obviously, it's very important for us as well that our systems and AI strategy matches our growth ambition for the future.

I spend a moment talking about our business model because our 3 business units create one integrated value creation model. We have our biotech unit where our core discovery and development unit sits. This is clearly validated. We have 3 potential obesity blockbuster assets in clinical development. And we greatly benefit from the CRO by doing most of our preclinical work internally. So there's great synergy and also scientific synergy between the units. The CRO is a stand-alone commercial unit. It's operationally and structurally independent and serves a large number of external customers, both on the biotech and pharma segment.

Obviously, it's great that we also have business coming from our own biotech research and also from the ventures in the future. Our new ventures will greatly benefit from the other units. Of course, we have immediate access both to capabilities on the biotech side in the biotech unit as well as access to doing studies for the preclinical development of venture assets as well. And on top of that, our core functions support our new ventures, which are asset-centric companies, which we operate. So altogether, we have value creation through faster pipeline progression, a broader and more resilient portfolio and our structured capital allocation across the company.

We also have different path to monetization and timing with that business setup. We believe this setup also sets us apart in terms of agility and resilience compared to other companies in the market. We are also clear about where we play. CRO plays in the preclinical discovery segment. The biotech unit covers everything from discovery till early clinical development. Phase Ib/IIa is our sweet spot, which we use to partner our assets with pharma partners. And on the ventures, we are a little bit more flexible depending on the needs of our strategic and financial partners. But generally, that will be assets just by clinical development and enabling studies still also Phase II. With this, I hand over to our biotech leadership, hence our CSO, Louise.

Yes. Thank you, Markus. And just trying to make the camera work. Let's take a look at the StreaMLine platform and how it enables a growing pipeline. As we work with peptide experts, we discover novel peptide-based drug candidates either alone or with a partner. And all our work is powered by in-house developed drug discovery platform, StreaMLine. Using this platform, we can quickly go from idea to a novel IP-protected development candidate. The platform takes advantage of AI and machine learning, which combined with high throughput wet lab screening of multiple peptide libraries. We use multiparameter optimization with set time and enables the identification of better molecules faster. So the strength of our streamlined drug discovery platform is reflected across both our internal and partner pipeline.

UCN2, our proprietary multiple selling program origins directly from the platform. ABBV295, the long-acting amylin analog now out-licensed to AbbVie is another example of the platform's ability to deliver clinically differentiated candidates. Our collaborations with Amylyx, Camurus and Hemab further validate the platform reproducibility and track record of generating differentiated peptide assets across therapeutic areas. Since our last update, we have made important progress across the pipeline, including the CTA submission for UCN2 assets. We've also seen strong progression in our partners' clinical stage obesity program. AbbVie reported positive top line Phase I MAD results for in ABBV295 and it plans to advance the program into Phase II in Q3.

In addition, Boehringer Ingelheim has decided to move the obesity triple agonist into Phase II in mid-'26. So together, this positions us to have 2 partnered assets entering Phase II in '26. So as you can look, we have been dedicated to understanding and treating obesity since the company's inception. And over the years, we built deep scientific expertise in this field from early discovery to clinical translation.

Today, I'll highlight 3 of our most advanced obesity assets, each designed with a differentiated profile compared to current standard of care and with blockbuster potential. But before getting into the details, let me take a step back and look at the broader obesity landscape and where the field is heading. Obesity continues to be a growing health challenge with a well-recognized need for novel treatment approaches. And while current therapies can deliver substantial weight loss, lean body mass, primarily muscle bones and connective tissue accounts for approximately 20% to 45% of the weight loss. We believe that the next generation of treatments will increasingly focus on the quality of the weight loss, in other words, maximize fat mass loss of preserving or even increasing lean muscle mass. Differentiation will likely also come from improved tolerability, multi-target strategies and the ability to address comorbidities.

Gubra's pipeline is strategically positioned to meet these emerging trends. First, we have the long-acting amylin analog, ABBV295 now out-licensed to AbbVie. A key differentiator of the amylin class is the potential to deliver clinically meaningful weight loss with a favorable tolerability profile, supporting the growing focus on better tolerated obesity treatment. Secondly, we have the triple agonist developed in partnership with Boehringer Ingelheim. This asset reflects the trend towards multi-target approaches with potential to enhance efficacy through simultaneous engagement of receptors. And finally, we have the next-in-line UCN2 program. This program built on a novel mode of action, UCN2 is designed to address the emerging focus on body composition with the potential to decrease fat mass while preserving mass and function in combination with weight management therapy.

So let's take a closer look at these programs. Starting with the long-acting amylin analog in development for obesity. A key highlight this quarter was AbbVie reporting positive top line results from the Phase I multiple ascending dose study. In this study, once weekly dosing with 295 demonstrated a clinically meaningful weight loss of almost 10% after only 12 weeks of treatment. And importantly, comparable weight loss was also observed with less frequent dosing, including every other week and once monthly dosing, really highlighting the potential here for dosing flexibility. 295 demonstrated a favorable tolerability profile at all dose levels. Adverse events were predominantly GI-related, mild and transient. So taken together, these results are encouraging and support the potential of 295 to deliver a robust weight loss with a favorable solubility profile. So really further underscoring its potential as a differentiated therapeutic option in the evolving obesity treatment landscape. So the program is now advancing in a Phase Ib study in obese patients aiming for higher female population and the Phase II program is expected to begin Q3 this year.

So additionally, we have the triple agonist developed in partnership with Boehringer Ingelheim for the treatment of obesity. This long-acting first-in-class asset targets the GLP-1, the GIP and the [ NPY2 ] receptors to engage complementary pathways involved in body weight regulation. Following encouraging Phase I results shown a meaningful weight loss and a favorable safety profile, Boehringer Ingelheim has decided to advance the program into Phase II clinical development midyear. We see this as further validation of the asset potential as well as Gubra's scientific innovation and partnering capabilities. With that overview, I'll now hand over to Thomas, our CDMO, who will provide further details on the UCN2 program.

Yes. Thank you, Louise. UCN2 is Gubra's next mega program. Based on the differentiated mechanism of action of urocortin 2, our drug candidate group UCN2 has the potential to address a key unmet medical needs in metabolic and cardiorenal indications. Native UCN2 belongs to the family of corticotropin releasing hormones and is a highly selective endogenous agonist of the CRH (sic) [ CHRH ] receptor 2. This receptor is expressed in multiple relevant tissues and mediates the effect of UCN2. In the adipose tissue, UCN2 administration results in an acute lipolytic effect. Longer-term receptor activation results in a reduction of heat content of lymphocytes hence reduction of adipose tissue inflammation.

In the skeletal muscle, which is the main target tissue of UCN2, protein facilitates protein synthesis, anabolic effects and at the same time, inhibits catabolism. In addition, UCN2 improves mitochondrial function, oxidative metabolism resulting in increased fat oxidation, improved muscle quality. And based on these physiological effects of UCN2, administration of UCN2 is expected to result in both increased muscle volume and an improved muscle function. Cardiovascular effects of UCN2 include vasodilation, including a reduction of pre and after load, which along with the positive inotropic effect result in improved cardiac output. In addition, UCN2 elicits antifibrotic effects, which are thought to improve maladaptive fibrotic remodeling of the heart following injury.

Renal benefits of UCN2 are less in our study, but the expression of the receptor in the renal vasculature and proximal tumors suggest a potential real benefit based on improved renal fusion. Similar to the heart, antifibrotic effects would also contribute to improvement of renal fibrotic remodeling in the context of chronic kidney disease. So our drug candidate GUB-UCN2 is a 38 amino acid peptide engineered for high CRH receptor 2 selectivity and extended the half-life supporting once-weekly subcutaneous administration in humans. GUB-UCN2 has been comprehensively characterized in preclinical studies, each will including preclinical pharmacology studies and high fat diet-induced obese rats.

This slide summarizes results from a study in obese rats demonstrating that GUB-UCN2 selectively decreases fat mass and restores semaglutide-induced lean mass loss. The graph on the left-hand side shows the effect on fat mass. GUB-UCN2 alone drives a significant reduction in fat mass represented by the green bar. In combination with semaglutide, GUB-UCN demonstrates an additive effect on fat mass reduction as shown by the blue bar. So this reduction in fat mass was achieved while preserving and even improving lean mass as shown by the green bar in the middle graph. The loss of lean mass with semaglutide demonstrated by the purple bar was really prevented when GUB-UCN2 was co-administered with semaglutide as shown by the blue bar.

As expected with this mechanism of action, GUB-UCN2 resulted in an improved body composition and maintenance of semaglutide treatment-related weight loss as shown in the graph on the right-hand side. So based on a compelling preclinical package, we are now planning to enter clinical development in the second half of this year. As indicated earlier, our drug product candidate possess the desired pharmacological and [indiscernible] characteristics to support once-weekly subcutaneous dosing. Based on its mechanism of action, we expect favorable effect on body composition with an increase in muscle and decrease in fat mass alongside with an improvement of muscle quality when administered alone or in combination with incretin-based therapy.

As a consequence, we believe that GUB-UCN2 has the potential to improve muscle function and physical performance. We therefore target obesity drug-induced muscle loss as the first indication. But beyond that and based on potential favorable effects on insulin sensitivity and also glucose homeostasis as well as cardiac and renal function, we believe that GUB-UCN2 has very broad expansion potential into metabolic and cardiorenal indications. So we plan to discuss details of the planned trial and development strategy in GUB-UCN2 focused R&D Day following initiation of dosing in the clinic.

However, to provide an outlook already today, we are planning to execute a very ambitious Phase I/IIa trial in approximately 188 participants with the intent to investigate safety, tolerability and initial efficacy of GUB-UCN2 with regards to effects on muscle volume and muscle function, which we believe are very relevant and important endpoints for the indications we are pursuing. We are also investigating that as a monotherapy or in combination with incretin-based therapy. With that, I'm concluding on the UCN2 section and hand over to Zoe, our Head of Gubra Ventures.

Thank you, Thomas. Good morning. Gubra Ventures is our value accelerator, the newest business unit designed to amplify what the group already does exceptionally well. Ventures is a deliberate extension of Gubra's capabilities into external asset creation and company building, leveraging external capital with the group's scientific infrastructure as a competitive differentiator. So why Ventures? The strategic logic for Ventures rests on 4 pillars. First shots on goal. Our biotech pipeline is focused and disciplined, but there are validated biological hypotheses and external asset opportunities that fall outside of our core pipeline prioritization. These opportunities are where we're hunting for Ventures.

Second, disease and technology area expansion. The economic and innovation landscape is evolving rapidly, new biology, new modalities, new competitive dynamics. Some of the most interesting opportunities sit adjacent to our current focus in metabolic disease and immunology and inflammation. Ventures gives us a vehicle to explore those adjacencies with appropriate risk ring-fencing. Third, return on investment. Ventures is designed to generate financial returns through future exits, licensing, M&A or stand-alone value creation. This is a capital allocation story as much as a scientific one, and the BD and M&A levers are central to how that value is ultimately realized.

And then fourth, market intelligence. So by actively building in emerging areas, we stay close to the market to competitive signals and to where the field is moving. And in this case, 3 business units leverage synergies from early target exploration right through to clinical development. So the bottom line is that Ventures will build companies based on externally sourced assets using external capital where necessary and Gubra's infrastructure to deliver pipeline optionality, strategic intelligence and financial return. So why is Gubra uniquely positioned today? Why us, why now? The answer is that 2 things are converging. Gubra's platform is maturing. We have peptide discovery capabilities, optimization platforms, translational pharmacology and deep metabolic disease biology that took years to build. And at the same time, the innovation landscape is shifting. Many innovative ideas and programs are undercapitalized, positioned poorly or spun out without the scientific infrastructure to advance incredibly. And that's exactly where Gubra Ventures can add value. We bring genuine scientific differentiation to bear on externally sourced assets.

The key discipline here is moving beyond obesity in a structured way, expanding into adjacent disease areas where our CRO, peptide and platform expertise give us a real edge, not just a financial position. In terms of risk architecture, I just want to spend a moment here because it's obviously front of mind. And the right way to think about venture risk is at the portfolio level, not the individual venture level. Each venture will sit somewhere on 3 risk axes: scientific risk from novel biology through to validated pathways, technology risk from new modalities through to proven formats and clinical risk from early discovery and preclinical stage through to clinical stage assets. And no single venture needs to be low risk across all 3 dimensions. What matters is the portfolio in aggregate is diversified across those axes. A higher risk scientific fact may be paired with a more validated technology format or a novel biology program might be at clinical stage.

The portfolio construction logic manages exposure at the group level. And this is a meaningful departure from how individual biotech companies think about their pipelines, and it's one of the structural advantages of the ventures model. We're not betting on one asset. We're building a diversified basket of ventures, each lean and asset-centric with Gubra infrastructure underpinning all of them. And so finally, the collaboration model, and this is the heart of what I'm talking about and where the capital efficiency story lives. Ventures will be deliberately lean. We're not building a stand-alone infrastructure from scratch and each venture company will access shared [indiscernible] resources, CRO models and translational capabilities from Gubra CRO, peptide expertise and AI-driven discovery platforms from Gubra Biotech's StreaMLine infrastructure and development functions, including clinical development, CMC and toxicology. And core group functions will be shared across the organization.

What this means in practice is that a ventures company can operate with a fraction of the fixed cost base as a stand-alone biotech while accessing capabilities that most early-stage companies spends years and significant capital to build. And that's our structural edge. Our CRO in particular, is perceived by external partners as a key value enabler for ventures, and it makes the proposition credible and commercially attractive. And so to summarize, Gubra Ventures is a capital-efficient, scientifically differentiated vehicle for external asset creation and company building. It's built on Gubra's existing strengths and structured to deliver pipeline optionality, market intelligence and financial returns. We're at an early stage in the journey, and we're being deliberate about how we build, and we'll share more on pipeline sourcing, ventures and capital structure as those conversations mature. And with that, I'll hand over to my colleague, Trine, to talk about Gubra CRO. Thank you.

Thank you for that, Zoe. As Markus and Zoe mentioned, the CRO remains a core value enabler for Gubra. We've had a strong track record of stable growth in both revenue and EBIT over the years, and this has always laid a solid financial foundation for Gubra. The CRO is considered a scientific leader by our customers and our strategic direction to expand on that position is clear. We still see volatility in the market, and it is recovering slower than expected. Demands remained soft, especially in U.S. and among biotech, small biotech companies. Since Q4 2025, we have had a sequential improvement of 25% on top line growth. However, we are not where we need to be. We still experience longer decision cycles and increased competition on standard studies.

Despite this market outlook, we remain cautiously optimistic about a gradual recovery during the second half of 2026. We are encouraged by improving commercial signals and early indications of more activity across selected large pharma accounts and within obesity and MASH segments. To leverage this momentum and to get back to growth, we have one clear priority, which is to double down on commercial execution. We're expanding our presence in U.S., including an expansion of our sales team with 20%, and we're accelerating the launch of our women's health and sarcopenia platforms. We are also leveraging a key trend to use AI and machine learning in development of our services. This has always been an instrumental part of our way of working for years in 3D imaging and 2D histology, and we also leverage these technologies in our operational excellence efforts to digitalize our workflows end-to-end.

The CRO has a strong differentiated service portfolio, and we're serving 17 of the largest pharma companies globally. They work with us because they know we can consistently deliver complex models at scale with high-quality and unbiased data, and we can deliver at speed with flexibility and excellent scientific guidance. We always strive to be ahead of the curve, focusing on our world-class models and highly specialized technologies. Our newly launched models in women's health and sarcopenia are clear examples of that. And very soon, we will also be launching a new service focused on advanced behavioral analysis. As mentioned, our women's health platform is an example of where we are ahead of the curve. There is a huge unmet need in the entire women's health area. And we're driving innovation in this area, leveraging our preclinical models and advanced 3D imaging capabilities. We've already made strong progress in this area, and we position Gubra as a leading preclinical CRO in PCOS, polycystic ovary syndrome, POI, primary ovarian insufficiency and menopause.

As part of that progress, our 3D imaging team has developed an advanced whole organ imaging platform with absolute surgical quantification and a capability that we believe can be meaningful raising the standards for reproductive biology and toxicology research. This is an important as it enables a more complete and precise evaluation of ovarian tissue than conventional approaches have been able to do. This has a clear potential to significantly improve preclinical decision-making across both women's health and broader safety assessment programs.

We are already expanding commercial engagement across the market from specialist biotech companies to large pharma companies are increasing their focus on women's health. Taken together, our differentiated models, expanding customer dialogues and unique image expertise position us well to become a premium partner in preclinical compound evaluation for PCOS, POI and menopause over the coming years. And now I will hand it over to you, Kristian , presenting the financial results and outlook.

Thank you, Trine. And let's start with the results in the first quarter and the biotech business. As you can see here, we had an improvement in the first quarter, mainly driven by milestone from the Amylyx collaboration. And this is also what you see in different quarters and when we receive milestones, the results can be a bit lumpy as it was last year in a very positive fashion. So -- and we also had this milestone in the first quarter driving up the revenue and that was also the reason behind the improvement in earnings compared to the same quarter last year.

Turning to the CRO business. Here, we saw a strong improvement compared to Q4 last year. So revenue increased by around 26% However, a small decline compared to same quarter last year. The main growth driver continues to be obesity, where Gubra is really, really strong. But as Trine also said, there's still macroeconomic uncertainty that continue to weigh on especially smaller biotech clients and longer decision cycles. Similar trend on earnings, an improvement in the first quarter, turning a small loss in Q4 into a small profit in the first quarter of '26. But again, we want to be at a different level when we conclude the year '26 and with the initiatives and the trends that Trine spoke about here just before.

Rounding off with the outlook and guidance. The Biotech guidance unchanged on the cost we guided for. In the CRO segment, we reduced our growth expectation slightly. So now we expect growth of 0% to 10% revenue growth for external revenue. Importantly, also with the business unit structure, we also sell internally services from the CRO business to the Biotech segment and that we expect to be around DKK 50 million. That's on top of the external revenue. With that, we have concluded our presentation and now open up for questions.

[Operator Instructions] The next question comes from Thomas Bowers from SEB.

A couple of questions. So firstly, maybe just to kick off with GUB-UCN2. Can you maybe elaborate a little bit on the reasons behind, you would say, longer than normal CTA process here? Should we interpret this purely as extended regulatory discussions around, for example, trial endpoints? Or is there anything in regards to the preclinical or tox-related data that has been a concern maybe requesting additional data? And then second to that, just what's your level of confidence in initiating the trial here in the second half? And are we likely looking at Q3 rather than Q4?

And then lastly, on UCN2. So in regards to the U.S. market, clear guidance from FDA in regards to that 5% weight loss guidelines. And with UCN 2, you are likely limited somewhat with the incremental weight loss as monotherapy. So do you see a viable path here without any new guidelines? And then also in addition to that combination with, for example, [indiscernible] should we expect UPN2 to demonstrate incremental weight loss on top of GLP-1? Or do you think a combination compared to placebo should be more than sufficient?

Thank you very much, Thomas. And actually, Thomas will answer those questions.

Yes. Thank you for the questions. So these are multiple questions, but let me go through them one by one. The first question related to the start of the clinical trial. The clinical trial application is still under review by the health authority, which is BfArM in Germany and the associated ethics committee. And this is not unusual for a trial of the complexity that I presented earlier in the slide, yes. Remember, this is a combined Phase I/IIa trial, yes, where we essentially combine 2 trials in one single clinical trial protocol with the appropriate patient population and the appropriate endpoints to really achieve clinical proof of concept, yes. And that results essentially in a very complex documentation with regards to key trial documents and administrative documents, particularly the clinical trial protocol form consent form and administrative documentation.

And for that reason, there are clarifying questions, in particular on the protocol on the ICF from the BfArM and the ethics committee that we are now addressing and discussing with the agency. Nonetheless, we anticipate approval of the clinical trial application in time for trial initiation in the second half of '26. So with regards to the second question related to body weight, here, just a reminder that GUB-UCN2 is not developed as an obesity drug. We do see really the advantage and the benefit for patients with this mechanism of action and the fact that we can favorably influence body composition. We can avoid that patients experience a loss of liver and muscle mass and can drive basically preservation of muscle function with this mechanism of action.

We expect that we have an additive effect on fat mass loss but would not see the drug being positioned within the obesity market. From that perspective, we do see that UCN2 would be used in combination with incretin-based therapies. And we have tested basically multiple incretin-based therapies and actually demonstrated that GUB-UCN2 is effective on top of those. And I just have shown you the semaglutide data today in the presentation. For indication expansions into other metabolic cardiorenal indications, there is, of course, the opportunity to evaluate UCN2 as a monotherapy. And based on the data that we are planning to generate in the clinical trial, I think we have then all options to actually explore the further positioning of UCN2 in the market. Thank you.

Can I just follow up just maybe just as a reminder, I have noted whether you disclosed it. But in the trial design of UCN2, are you also planning to already include a combination with incretin in the Phase IIa path?

So we would be actually discussing that at the R&D Day, which we initiate then after approval of the clinical trial and then we'll discuss really details not only of the trial, but also with regards to the strategy, right, and how we view positioning of the drug candidate in the context of the clinical trial design.

The next question comes from Suzanne van Voorthuizen from Kempen.

This is Suzanne from Kempen. Maybe first on the amylin and triple agonist programs, can you remind us of the partnership economics and what we should be expecting in terms of milestone payments on the start of the Phase II trials for each? And secondly, can you elaborate on the additional Phase I study that AbbVie has started with the amylin? What is similar or different in that study compared to the Phase I we've seen the data from already? And lastly, on the ventures part, does your previous guidance for first venture creation in the second half of this year still stand?

Thank you very much, Suzanne. So Kristian will take the first question, Louise will take then second and the third.

Just starting with the deal packages and the milestones and starting off with ABBV295, the amylin. So there's a number of milestones, both development milestones and sales milestones for a total deal package of USD 1.9 billion. On top of that comes royalties. We don't disclose the details of each milestone. But again, I want to reiterate both development and sales milestones for a total value of USD 1.9 billion. And essentially, the same level of detail that is what we also provide for the triple agonist. However, the deal package is somewhat lower there, is around EUR 240 million. And again, both development and sales milestones and royalties on top of that. But no details on the size and what triggers the individual milestones.

Yes. So to answer the second question here with regards to additional Phase I study that AbbVie is running and the core differences here compared to the former Phase I MAD study. So in the first study, that cohort primarily included male participants of a lower BMI group. And in the next study here that is run by AbbVie, it will be conducted in obese patients. So really aiming for a much higher BMI cohort, 30 to 45 is the inclusion criteria here. And in addition, the ambition is really also to increase the number of the females participating in the study. Then concerning the creation of our first venture, we are on track. We're currently evaluating a number of opportunities in line with the scope that I outlined in the main presentation, and we will be giving more details of those ventures at the R&D Day later this year.

The next question comes from Rajan Sharma from Goldman Sachs.

A couple around the UCN2 asset as well. So I realize there will be more details at the R&D Day, as you mentioned. But could you just help us understand some of the timelines here? And what are your expectations for potential first clinical data both in the obese or the obesity muscle preservation indication and then also beyond that? And then secondly, just maybe following up from a question earlier in terms of definition of obesity drug-induced muscle loss, how should we think about that? And how do you implement that into a clinical trial? There's, of course, an argument that muscle loss is an expected consequence of weight loss. So how do you isolate what may be sort of an unhealthy level of muscle loss in a clinical trial?

The question goes to Thomas.

Yes. So with regards to the trial timelines, I think we will be speaking in more detail about it once we have the trial approved, right, and the first patient to dose because that gives us then the confidence to speak about the timing of the incoming data. With regards to the obesity and obesity indication in the context of incretin therapy induced muscle loss, this is a very important question. And from our perspective, what is really relevant and important is muscle function and physical performance, not muscle volume or muscle mass itself. It's the benefit that we can bring to the patient that would differentiate GUB-UCN2 from other mechanisms in the market. And this is what we are looking to demonstrate in our first clinical program, and we demonstrate that there is a differentiated product from weight loss.

[Operator Instructions]

Okay. I think that seems to conclude the questions from the phone. We received a couple of written questions also. I think one of these has been answered already. Another question is also on our drug discovery programs for obesity and what could come next after the assets already discussed here. So I give that over to Louise.

Yes. Thank you for the question. And I would say that for early discovery programs, we are, of course, working really, really hard on advancing those. But the specific timing on activities here, I would not comment on today. I think we will leave that and then we will, of course, announce when we have anything to share.

Okay. Operator, it seems that there are no further questions. We don't have further written questions either. So I hand over to Markus to just some concluding comments.

Well, thank you very much for participation and your questions. I think Gubra has great momentum, and we have an ambitious growth aspiration and growth phase ahead of us. So we look forward to discuss our progress in the next call in the next quarter. Thank you very much.

Welcome to the conference call. [Operator Instructions] Now, I will hand the conference over to the speakers. Please go ahead.

Good morning. Welcome to the Gubra investor presentation. My name is Markus Rohrwild. I'm the CEO of Gubra. I'm joined here with our Chief Financial Officer, Kristian; our Chief Scientific Officer, Louise; our Chief Medical and Development Officer, Thomas; the Head of Gubra Ventures, Zoe; and the Head of the Gubra CRO, Trine.

I will present an overview about the company, and then we will move into the individual units. Just as a reminder, Gubra is a disease-agnostic techbio company and we have deep expertise in peptide therapeutics and preclinical research services.

Starting 2006 (sic) [ 2026 ], we will operate in 3 independent but synergistic business units. First, our Gubra Biotech unit, where we discover and develop peptide therapeutics to clinical proof of concept, our key value driver. Second, the Gubra CRO, where we deliver high-quality preclinical research services to external customers, but also for our internal units, Biotech unit and to Ventures.

And our new business unit, Gubra Ventures, where we incubate high-value assets adjacent to our core therapeutic areas to create and accelerate additional value, all based in our commitment to society in Gubra Green, partially served by our ESG initiatives, but also we are investing 10% of our pretax profits into green initiatives.

2025 was a record year for Gubra record revenue of $400 million, record operating profit of $325 million. Currently, our advanced pipeline is in obesity, but we will also move beyond metabolic diseases. The company has around 300 employees now, and we are significantly expanding our facilities to do even more research and to even do more contract research.

This is the historic growth journey of Gubra, and you can see 2025 stands out as a record year. This is driven by the deal with AbbVie where we out-licensed our amylin compound and the high upfront payment created the record revenues for 2025.

This is our management team. Since I started in September 2025 as the CEO, I've made some changes to the leadership team. I brought in a new Chief Medical Officer with Thomas, who is strengthening our drug development team. So, we, in the future, can develop multiple clinical assets in parallel. Zoe was recently announced as Head of Gubra Ventures. And also, we have recently announced Grigo as new Chief Technology Officer. Technology is very important for our innovation. We are a true techbio company. So, we are very glad that we were able to recruit Grigo.

A couple of key events in 2025. You're all aware of this. Obviously, the Amylin deal was a landmark deal for us, which not only proved the validity of our business model, but also delivered the strong financial results we are enjoying for 2025. We had a data readout on Amylin, early clinical data, which is very promising. We had fantastic preclinical data on our lead asset UCN2. You will hear and see more about that later in the presentation. And we did a couple of additional deals and partnerships, mentioning the Camurus partnership on -- the collaboration on PTH agent and also Boehringer Ingelheim has announced that they are advancing our triple agonist in obesity into mid-stage clinical development. So, 2025 was full of very valuable milestones for Gubra.

Now, we have a good foundation for growth. We are in a very good liquidity position. We have a world-class peptide and preclinical service company streamlined. We have a discovery platform, which can deliver from an idea to a drug development candidate, high-quality assets in a very short amount of time. And we also -- now we are ready to move into other areas beyond obesity to create more value and more clinical candidates.

So, if we look forward, you can expect that we will expand our pipeline. We will also focus on having multiple mega programs of high commercial value. One example is UCN2, which will have multi-indication programs and, of course, represents a significant value to our pipeline. We will also look into, in parallel, license complementary assets to our pipeline. And at the same time, we will strengthen our CRO by delivering new and innovative models for our customers worldwide.

Just to summarize, how we play and where we play, I'd like to mention that, again, we are now operating in 3 business units. We have our proprietary AI-based drug discovery platform in Gubra Biotech. Here, we will have a pipeline of high-value assets. Now we talk a lot about UCN2, but there is more to come. And we will develop these assets to clinical proof-of-concept for maximum value creation.

So CRO has done very well in recent years, and we have a world-class platform to serve our customers. And Trine will talk a little bit about also our new innovations and services in that space. So, we are very confident that this business will also in the future be very profitable. It's strategic value enabler also for our Biotech unit and our Ventures.

And our ventures are essentially lean and asset-centric spinouts of the company. They are operationally separated, but adjacent to our core areas, and we will do these together with financial and strategic partners to maximize value for us, all based on our commitment to society with Gubra Green.

To be a little bit more specific and clear about where we play in the 3 business units, I'd like to review this in more detail. So, our discovery is primarily preclinically in terms of our CRO services, where the CRO provides multiple high-quality models in the area of lead optimization and preclinical validation. Our CRO plays all the way from drug discovery to clinical proof of concept.

When I talk about clinical proof of concept, what I mean is Phase Ib results or Phase IIa, which essentially is a place of value creation and value inflection for our Biotech in the area of early drug development. And for Gubra Ventures, it's a little bit more flexible. But, generally speaking, we will look into -- for assets which are at the drug development stage, moving towards clinical proof of concept and beyond, but it also will depend on the needs and strategic imperatives of the partners and the particular assets we are playing with.

So, with this, I hand over to the Biotech unit and to Louise.

Thank you, Markus. So, let's take a look at the StreaMLine platform and how it enables a growing pipeline. So, at Gubra, we're peptide experts, and we discover novel peptide-based therapeutics either alone or with a partner. And all our work is powered by in-house developed drug discovery platform, StreaMLine. Using this platform, we can quickly go from idea to a novel IP-protected development candidate. And the platform takes advantage of AI and machine learning, which is combined with high throughput wet lab screening of multiple peptide libraries, thousands of peptides.

We use multiparameter optimization, which saves time and enables the identification of better molecules faster. So, the strength of a streamlined drug discovery platform is reflected across both our internal and partnered pipeline. UCN2, a proprietary high-quality weight loss asset now advancing towards the clinic origins directly from the platform.

In addition, ABBV-295, the long-acting amylin analog out-licensed to AbbVie exemplifies the platform's ability to deliver clinically-differentiated candidate. The Amylyx, Camurus and Hemab collaborations further validates the platform's reproducibility and track record of consistently generating differentiated peptide assets across therapeutic areas.

Since the last update, several important developments have taken place in the early pipeline. We have partnered a PTH program with Camurus. This collaboration combines Gubra's parathyroid hormone analog with Camurus' FluidCrystal technology to enable extended and patient-friendly dosing for patients with hypoparathyroidism.

With Amylyx, we have now nominated a development candidate, a long-acting GLP-1 receptor antagonist, now advancing into preclinical development. And the Hemab collaboration has, likewise, progressed into preclinical development. We've also added 2 new early-stage programs to the pipeline, a differentiated obesity asset and a Cachexia program, expanding our metabolic footprint beyond obesity.

At the same time, we have concluded the third collaboration with Boehringer Ingelheim, a very early target discovery program. And finally, as part of a disciplined portfolio review and prioritization process, we have decided to discontinue our GLP-1 monotherapy and Orexin programs to focus resources on higher priority opportunities.

At Gubra, we have been dedicated to understanding and treating obesity since the company's inception. And over the years, we've built deep scientific expertise in this field from early discovery to clinical translation. And today, I'll highlight 3 of our most advanced obesity assets, each designed with a differentiated profile compared to current standard of care and with blockbuster potential.

But before we go into the details, let's take a step back and consider the broader obesity landscape and where the next generation of therapy is heading. Obesity continues to be a growing global health care challenge with a well-recognized need for novel treatment approaches. And while current therapies have transformed treatment and can deliver substantial weight loss, lean body mass, primarily muscle, bones and connective tissue accounts for 20% to 45% of the weight loss.

We believe the next generation of treatment will increasingly focus on the quality of the weight loss. In other words, maximize fat muscle loss while preserving or even increasing lean muscle mass. In addition, differentiation will likely come from improved tolerability and multi-target strategies, including dual and triple receptor agonists. Gubra's pipeline is strategically positioned to meet these emerging trends.

First, we have the long-acting amylin analog, ABBV-295 now out-licensed to AbbVie. 295 is in development for weight management indication and could be positioned as an alternative on addition to incretin-based treatments. It features a balanced receptor profile on the amylin and calcitonin receptors, just like native amylin combined with an exceptionally long half-life of 11 days.

So, a key differentiating factor of the amylin class is the potential to deliver clinically-meaningful weight loss with a favorable tolerability profile. And interim data from the MAD study support this profile. Here, 295 was well tolerated with adverse events being predominantly mild and GI related and 295 demonstrated a dose-dependent weight loss of almost 8% compared with a 2% increase in the placebo group after just 6 weeks of treatment.

So, these findings reinforce the potential of amylin as a next-generation weight loss therapy with improved tolerability profile. The program is currently advancing in a Phase I MAD study led by AbbVie. Here, longer treatment durations are also being explored.

So, secondly, we have the triple agonist, long-acting first-in-class and developed in partnership with Boehringer Ingelheim. So, following encouraging Phase I data demonstrating meaningful weight loss and a favorable safety profile in patients and individuals with overweight and obesity, Boehringer Ingelheim has decided to progress the program into the next phase of clinical development.

And finally, we have our next in line internal obesity program focused on high-quality weight loss. This program builds on a novel mechanism, a long-acting UCN2 analog selectively targeting the corticotropin-releasing hormone receptor 2 and it's designed for once weekly dosing.

And with that overview, I'll now hand over to Thomas, our CDMO, who will provide further details on the UCN2 program.

Thank you, Louise. UCN2 provides a novel and differentiated mechanism of action for high-quality weight loss. And that actually means a strategic shift from pure reduction of body weight towards body re-composition, a loss of fat mass and at the same time, maintenance or increase of muscle mass, which is functionally very important.

So, UCN mediates its action through a specific receptor called CRHR2, which is expressed on muscle tissue, in adipose tissue and in the cardiovascular system. In the muscle, UCN2 mediates anabolic and suppresses catabolic effects. And it shifts the metabolism towards oxidative metabolism, which also results in loss of intramuscular fat. The result of that could be an improved muscle function and an improved metabolism of glucose.

In the adipose tissue, UCN2 inhibits lipid storage and reduces really significant fat mass and also reduces inflammation of the adipose tissue and the release of pro-inflammatory cytokines. In the cardiovascular system, we do see an increase in cardiac output, which is mainly driven by 2 effects: number one, a direct inotropic effect on cardiomyocytes and vasodilation, which results in a reduction of pre and after load. And together, we see cardiac output increase.

Longer-term administration of UCN2 also inhibits maladaptive, in particular hypertrophic and fibrotic remodeling that we see in a number of cardiovascular diseases. So, our compound, GUB-UCN2 is a long acting Urocortin-2 peptide analog. It's very highly selective for the CRHR2 receptor and suitable for once-weekly subcutaneous dosing.

The benefits we aim at exploring in the clinic are related to the mechanism of action that I alluded to earlier, including improved body composition with increased muscle mass and decreased fat mass; improved muscle function, which is very important from a patient perspective; and additional metabolic and cardiorenal benefits. All these benefits support the primary indication we are currently pursuing of obesity drug-induced muscle loss.

However, based on its mechanism of action, UCN2 also provides the opportunity for broad indication expansion opportunities. On one hand, we intends to explore and leverage favorable effects on metabolism and muscle to look into muscle wasting and loss, for example, type 2 diabetes-related muscle loss or sarcopenia. And based on its favorable cardiorenal effects, we are looking into ischemia-reperfusion injury, heart failure and chronic kidney disease indications.

Our very ambitious first-in-human Phase I/IIa clinical trial has just been submitted to the health authority for review. And it's a trial that was specifically designed not only to support the primary indication, but also to deliver data that would allow a meaningful regulatory interaction on the further development path of UCN2 and also help us to identify the best indication expansion opportunities. It's a trial that will explore UCN2 in 188 participants. These are participants with obesity with or without diabetes, and we will investigate UCN2 as monotherapy and in combination with incretin-based therapy.

We will, of course, evaluate safety, tolerability, PK, but also look at preliminary efficacy and here really focus on muscle volume, fat volume, muscle function endpoints and cardiorenal endpoints, which will help us to really fully unlock the potential of UCN2.

And with that, I would like to hand over to Trine Hamann, our Head of CRO.

Thank you for that, Thomas. I will be presenting Gubra CRO. Gubra was founded in 2008 as a preclinical CRO. And throughout the years, the CRO has laid a strong financial foundation for Gubra. We specialized preclinical CRO, primarily focused on metabolic and fibrotic diseases, where we work with 16 of top 20 pharmas and hundreds of smaller pharmas and biotech globally.

We combine our highly ranked translatable rodent models with advanced technologies, especially our models in MASH, obesity and kidney are best-in-class, and we are known for being able to handle high complexity and large studies. Besides launching women's health as a new disease area early in 2025, we also started working intensively on Sarcopenia, which is age-related loss of muscle. Here, we see a huge unmet medical need and an increasing age population. There are very few available animal models in this space, and we see high synergy with the metabolic space where we are already present.

Let me give an example of where we are world leading. We have, with our 3D imaging platform, built a highly automated whole organ platform with industry-leading throughput. We use custom design robotics and fully-automated light sheet microscopes where we can image up to 500 rodent organs per week. This is a scale that clearly differentiates us from traditional CROs that rely heavily on manual sampling handle.

For us, AI-driven analysis of large-scale image data sets is central to delivering clear and actionable results for the customers. For example, in obesity research, we visualize how the drug access the brain and activates the [ neural ] circuits controlling, for example, appetite. This enables direct comparison of compounds based on regional brain activity. This is highly scientific relevant and of high value to our customers.

So, this was a short introduction to the CRO, and I will now hand it over to Zoe, Head of Gubra Ventures.

Thank you, Trine. Let me briefly frame what we mean by Gubra Ventures, why we believe now it is the right moment and how this approach creates value for Gubra. First the what. A Venture for us is focused company creation around high potential science with a clear translational hypothesis. These are opportunities that sit naturally within Gubra's strengths that will benefit from being developed with their own strategic focus, governance and potentially external capital pathways.

Second, why now? Gubra's platforms and translational capabilities have reached a scale and maturity that allows us to pursue multiple parallel value creation paths. At the same time, external funding environment is increasingly rewarding focus, capital efficiency and clarity of strategy. We also at Gubra have a proven track record of working with trusted external partners, which makes this model practical and not just theoretical.

And finally, the how. Venture creation will allow earlier scientific derisking, sharper focus and greater strategic flexibility, all whilst preserving Gubra's core R&D engine. By placing the right assets in the right structures at the right time, we can support disciplined execution and create optionality downstream while remaining fully aligned with Gubra's strategic long-term priorities. So in short, Gubra Ventures is about focus, speed and thoughtful structuring using what Gubra already does very well to support sustainable value creation over time.

And with that, I'll hand over to Kristian. Thank you.

Thank you, Zoe. And let's turn to the financials, which is a very pleasant reading. So, in all aspects, it's been a strong result in the company's history, very high revenue of DKK 2.6 billion and a net profit of DKK 1.7 billion, of course, driven to some extent by -- or to a large extent by the AbbVie deal. I think the AbbVie deal is really important to emphasize. It's really a very good example of how we want to do it.

We develop novel peptides from our AI platform, take them into clinical proof of concept, then we out-license. So that is the footprint we want to do in other types of assets when we're going forward. So, I think this is a very good example in how we operate in our Biotech business.

We also, as you know, returned a significant amount to shareholders, DKK 1 billion in an extraordinary dividend. And still, despite that, we have a very strong liquidity position. So, a very, very good year in '25. And a strong outlook for '26. So, as we already talked about, we have 3 potential blockbuster obesity drugs in clinical development, and there's also a possibility to get some interesting readouts for at least 2 of them during '26. As Trine talked about, we have a very strong position in the CRO, and we had a good start to the year also here in '26. And with Ventures, we expect to launch our first venture in the second half of '26.

Looking into very briefly on the specific financials. Of course, Biotech business, a huge improvement in '25, driven by the upfront payment from the AbbVie deal and of course, also a significant improvement on earnings. Looking at the CRO business, we're down a bit compared to the record year '24. And the main delta has been the smaller biotech customers, especially in the U.S., where the funding environment for them has been a bit more challenging compared to recent years, so that's meaning longer decision cycles for placing orders with Gubra. We, nonetheless, have a pretty okay earnings still despite this decline, and we look to improve it in '26.

On the outlook, starting with the Biotech business, we'll spend a bit more in '26. That is primarily driven by the very ambitious and comprehensive clinical trial for UCM2 that plays on multiple indications. That is why we increased a bit compared to '25. CRO is a growth over and over for many years. In certain years, we could be slightly down. But in general, looking at the long-term picture, we want to grow it by 10%, and we expect to grow it by -- to 15% in '26 with a decent earnings.

With that, I hand over to Markus for some concluding remarks.

Thank you very much, Kristian. So, what are the things to watch out for Gubra 2026. I'd like to mention our UCM2 clinical development program. We expect to dose the first patient in the first half of the year, and we will disclose more details on the clinical trial design and the timing of the readouts in our R&D Day on June 30.

Moving ahead in terms of our discovery platform, we will invest in opportunities beyond obesity. So, we will add new flagship areas to our discovery and development focus areas. And also here, we will release more about our strategic plans in the middle of the year.

Our partnership model is a success model as shown by the deal with AbbVie. So we'll certainly aim to do more of these type of deals going forward. And pipeline expansion on the Biotech unit is, of course, a key value driver. So, it is very important for us to develop multiple assets in parallel so we can do more deals and we can bring more assets to clinical proof of concept.

So, we stop here and open up for questions.

[Operator Instructions] The next question comes from Thomas Bowers from SEB.

So, firstly, maybe if you could comment a little bit on the low end of your CRO revenue guidance growth range. So, I guess you have some positive impact from phasing from '25 with these new contracts signed in late '25. So, why should we think about you only getting to 5%? And also, can you maybe comment a little bit on the U.S. customer segment? Has that normalized? Or are you still seeing funding issues for, in particular, the smaller biotech customers?

And then a question on the margin outlook also for the CRO segment here. So, in 2025, you started above 25%, so 25% to 31%, if I remember correctly. So, what's the main driver for you now seeing 22% to 25% here in '26? Is that mainly because you're now entering new areas like sarcopenia? Or what's the main driver here?

And then lastly, just on Gubra Ventures. So, you can say, given the, I guess, Roivant like [indiscernible], so should we expect you to, in the medium -- near to medium term, sort of in-license new compounds? Or do you think you have plenty of internal noncore assets, you can maybe call them and for those seek external funding or capital?

Thank you very much for those great questions. First question goes to Trine, the profitability question goes to Kristian and then Zoe and I will talk about Ventures.

Thank you very much for the question, Thomas. So, the results in 2025 should really be seen in the light of, as Kristian said, 2 years of 30% consecutive growth. But we -- and we have seen headwinds in U.S., particularly in the Biotech segment. I will also say that markets have stabilized, and we do see improvement from 2025. So, we are cautiously optimistic about the clear signs of recovery.

There is still volatility in the market, I would say, but especially at the -- towards the end of 2025 and in 2026, capital has been flowing into the ecosystem. We see more IPOs, M&As and general activity also benefiting the biotechs.

So, my expectation would be that we, within the next, I would say, 3 to 4 to 5, 6 months, we'll see an uptick in the market and that we will benefit from that. We can already see that there are clear signs of recovery. Decision cycles still are relatively slow, but we remain positive that we will see increased activity, especially in the U.S. and also among biotechs in 2026.

And on the profitability, I think we invest to make a broader CRO, investing in women's health, investing in sarcopenia, still investing in some other areas. And that, of course, doesn't generate earnings immediately. So that's why you can say that we guide for 20% to 25% in EBIT margin, still a healthy EBIT margin, but it also is a function of investing in new areas, as you said.

Very good. I think Zoe.

Yes, happy to take the question, and thank you for referencing our shared history with Roivant. When it comes down to deciding what becomes a venture, it really comes down to strategic fit. So, whilst there may be opportunities in the Gubra pipeline, we are actively looking outside for opportunities. And as I mentioned, these will be opportunities that lie within Gubra's biological strength. So that could be peptide-based therapeutics in therapeutic areas outside of our core therapeutic area strength or alternative modalities that fit with our core translational capabilities in obesity and metabolism that maybe aren't peptides. So, more on that to come throughout the year.

We'll take the next question now.

The next question comes from Suzanne van Voorthuizen from Kempen.

This is Suzanne from Kempen. I have one for each business unit. Maybe first on the CRO and the growth guidance for the coming year. Timing-wise, how should we expect the growth over the course of the year? Is this more back-end loaded? Or should we already start to see a good growth from Q1?

Second one is on the Biotech side for UCN2, the Phase I is very elaborate. There are no time lines on data yet, but any color you can give on -- or give a sense of how long such a study would take? And I'm wondering if you need the full study enrolled and completed for data or if there's a possibility to release interim data?

And lastly, for the Ventures arm, as you build your portfolio, could you give some color on what that would look like, for example, could you describe the sort of phenotype that you think of currently for the typical Gubra Ventures assets?

Thank you very much, Suzanne. Trine will take the first question. I will take the question on UCN2 and then Zoe can answer the last question.

Yes. Thank you, Suzanne, for that question. As I explained just before, I think we do see a positive trend capital floating into the ecosystem. Q1 has been a solid start for us, but I do expect that Q2, we will be able to see the full effect of the positive trends and the stabilization in the market. Also, we do see positive signs in Europe, where we see increase -- an increase in venture funding and also EU has launched a huge venture program Biotech EU starting in '26, where we will hopefully also see an effect in the latter part of '26. So, from Q2, I really expect to see this uptick in sales.

In terms of the UCN2 trial, this trial is a very ambitious Phase I, Phase IIa trial. So it has multiple parts. And you are right to assume that there are multiple readouts in 2027 and 2028. So, we will disclose the design and our estimated time lines on June 30. Zoe?

Thanks, Markus. Yes, I think the question was what will we be looking for? What would be a typical phenotype of an asset for Gubra Ventures? Well, we would be looking for assets that have some strong preclinical validation so that we have a clear scientific hypothesis that is translatable into early clinical proof of concept. And that would really be to align with Gubra's core strengths. So that would be the kind of scope we'd be looking at late preclinical into early clinical. And then apart from that, I would say we're keeping this very disciplined. We're looking at assets on a case-by-case basis, and we don't have a one-size-fits-all model.

Good, we'll take the next question now.

The next question comes from [ Theodore Robedle ] from Goldman Sachs.

So, firstly, when should the market expect a data update from the Phase I MAD study for ABBV-295? And to what extent do you think that 295 should show differentiation versus eloralintide and versus other amylins, both in terms of weight loss efficacy and then in terms of safety and tolerability?

This question goes to Louise.

Yes. So, thank you for this question. So, with regards to data outlook from the MAD study, what AbbVie have communicated is that they expect to see data during this year, and that will guide the progression into Phase II, which they also expect to start here in '26. With regards to competitive position of 295, then again, it has been designed with a dual -- as a dual molecule targeting both the amylin and calcitonin receptors basically just like native amylin and it has a very, very long half-life. What we have seen in the interim data from the MAD study is that we can deliver substantial body weight reduction with a very nice tolerability profile. So, we see no reason as to why GUBamy or 295 should not perform equally well as to eloralintide.

[Operator Instructions]

Okay. Operator, are there any further questions to the call?

There are no more questions at this time. So, I hand the conference back to the speakers for any closing comments.

Okay. Thank you, everyone, for participating in a record year of '25 and a strong outlook for '26. We speak again at the next quarterly call. Thank you.

Markus. Let us first reflect on 2025, an astounding year for Gubra.

How would you sum up 2025 for us?

2025 was a defining year for Gubra. Record revenue of EUR 350 million, record operating profits of EUR 300 million.

A couple of things to highlight: Our landmark deal with AbbVie around Amylin. It validated our platform, but it also delivered the strongest financial performance in Gubra's history. Second, Boehringer Ingelheim decided to advance our triple agonist in obesity into further development. And thirdly, our partnerships with Camurus and Amylyx, which demonstrated the speed of our AI-driven, streaMLine platform, from idea to drug development candidate.

The CRO had fantastic business growth in the recent years, and we expect the CRO revenue to grow double digit in the coming years as well. Despite macroeconomic headwinds in 2025, our CRO remains a high-quality partner for our customers as well as our internal units.

How will Gubra drive growth from here on?

Starting this year, we will operate in three independent but synergistic business units. We do that to maximize value growth, but also agility in an increasing challenging macroeconomic environment.

Let me start with our latest business unit, the Gubra Ventures. The Ventures will incubate asset-centric, high-value opportunities beyond our own pipeline. Second, our key value driver, our biotech unit, where we discover and develop our own assets towards clinical milestones. And thirdly, our CRO, delivering high-quality research services for external customers, but also for our Ventures and for our biotech unit.

At the core of our business there is, of course, our commitment to the society. We do that partly by our ESG initiatives in all our three units, but also via Gubra Green, where we invest 10% of our pretax profits every year. For example, in 2025, we have built our own solar power plant. And by 2030, we expect to be carbon negative and electricity self-sufficient.

I would like to take a moment to zoom in on our pipeline. Is there anything in particular you would like to highlight from our pipeline?

In particular, I'd like to highlight our UCN2 mega program. It is our third obesity blockbuster going into the clinic, and we will initiate an ambitious Phase I/IIa clinical program in the first half of this year. The obesity market is changing. In the past, it was all about the big drop, how fast can you lose weight? But now it's all about quality. And UCN2 is the right product for this. It was designed to decrease fat mass and at the same time, maintain lean mass such as muscle.

What excites you the most about the year ahead?

Many things excite me at Gubra. It's our UCN2 mega program. It's about the company bringing the third blockbuster into the clinic. It's about our ambition to become a top biotech company in Europe, and it's about our people. The Gubbies, they make everything happen, right? They deliver our key initiatives and they are essentially our secret sauce behind everything. Our people, the Gubbies, are the magic behind Gubra.

Thank you for standing by. My name is Karen, and I will be your conference operator today. At this time, I would like to welcome everyone to the Gubra Quarter 3 2025 Earnings Release. [Operator Instructions]

I will now turn the call over to Markus Rohrwild, CEO. Please go ahead.

Good morning, everybody. Also welcome from my side. My name is Markus Rohrwild, I'm the CEO of Gubra. I'm joined here by Louise, our CFO; and our CFO, Kristian. So we will start with our presentation. I will give a general overview, followed by Louise and then the financial results by Kristian before I wrap up.

As you know, at the core of our strategy, we have a dual business model. We have our discovery and partnerships, our key value driver and our sales services, which are strong enabler for our internal pipeline as well as our partnering. Our CO business has had the market growth over the long run. We had 30% growth year-on-year, and we delivered great data and service to 16 out of top 20 customers who [indiscernible] area. Our primary focus in [indiscernible] demonstrated environment our business model.

Now let's look at the first 9 months, and I think this tough fix for itself office so the or also on the revenue side of [indiscernible] margin side, [indiscernible] fund of sales extraordinary sale, which has a significant utility. In terms of highlights of 2025, of course, our [indiscernible] has demonstrated a fantastic [indiscernible] in the results, and we look forward for instance, asset to begin in the first half of 2026. This program is developed [indiscernible] high-quality vehicle and we will hear more about this from [ BBC ]. I mentioned the [indiscernible] us, and we have also had an extra [indiscernible] dividend of [ DKK 1 billion ] retail. [indiscernible] has shown great results in [indiscernible] 5 now. And stage 1 will stay very good. We also have a good [indiscernible], which is -- so we strongly believe in the [ EBITDA ].

Our CO business has seen a slight decline driven by macroeconomic uncertainties because led to some delays in decision making on our customers [indiscernible] like at the end of the [indiscernible]. And of course, also now from our [indiscernible] company in September this year, and we like to see in the company full potential.

I'm handing over to Louise.

Yes. So thank you. So let's take a look at internal discovery pipeline. At Gubra, [indiscernible] with a partner. For our work is [indiscernible] in-house developed drug discovery platform streamline. Using this platform, we could develop a set target into a [indiscernible] as successive development candidates. The platform takes advances of AI [indiscernible] combined with the good relet screening as notable peptide lasers, thousands of data. He use multiparameter optimization, which this time and enables the identification of the monies part.

So what you see here is an overview of the Gubra [indiscernible] pipeline. This growing pipeline is at the best [indiscernible] of the power and efficiency of a streamline discovery platform and an extensive [indiscernible]. We represent the internal equipment [indiscernible] partner. Unless the launch is using to equipment to high [indiscernible]. We are advancing the diversified portfolio, up early stepped concern a strong growth for future opportunities. [indiscernible] reflecting successful collaborations with leading in discrete players. Key highlights is the top line of our Phase I and footprint is the biggest out licensing fee [indiscernible] for so far. This underscores both design to explain and [indiscernible] pipeline.

[indiscernible]. We have been dedicated to understanding conceding the [indiscernible] misconception of the company. So [indiscernible] expertise in this field for early discovery to several to clinical cases. And today, [indiscernible] 2 of the most advanced [indiscernible] to current standard of care. But let's go line into the data. Let's take a moment and look on the quarter [indiscernible] and what's the next generation [indiscernible] will likely focus on. So it's no secret that [indiscernible] continues to be a growing [indiscernible] opportunity. And [indiscernible] is has substantial below, we need more stores in the [indiscernible] if we want to take our patients [indiscernible]. In addition, this will acknowledge the [indiscernible] accounts its 20% to 40% of the [indiscernible]. There will be a plan shift in the next generation of seed with a focus on quality, [indiscernible].

In other words, we still aim to maximize that mess while serving our [indiscernible]. But this is the next generation of obesity assets to a different to improved solubility profile and [indiscernible] related to mobility. Gubra's pipeline. [indiscernible] is persistent to make this [indiscernible] we have announced active family analog ABBV-295, now outlicensed to [indiscernible]. [indiscernible] is the development for wealth management indication -- how could be persistent book has an alternative or add to interties business. [indiscernible] the results from. So a [indiscernible], it's well [ celebrated ] [indiscernible] of almost 8% in the 2-milligram compared with a 2% we gain in the placebo. After just 6 weeks of treatment. So these signs supports analyst successes to deliver 2 meaningful weight loss to have improved probability profile.

So next in line is the internal obesity program focused on high quality [indiscernible]. This program goes in a new mechanism. [indiscernible] in designed to deliver a set and more sustainable [ Fotios ] program. We have designed a selected new [ CMT ] analog with a target profile of [indiscernible]. You as content the emerging model for this patient, [indiscernible] be competition, increasing much on less, reducing flatness but also operating key obesity related to mobilities such as cardiovascular and kidney diseases. Today, pursuing on the [indiscernible].

Starting with muscle from this study in very good and that prudent extended period of time. We will see that [indiscernible] has a neutral effect on body weight. When it [indiscernible] mass and decreasing [ blackness ]. We can also appreciate the other [indiscernible] such as [indiscernible] and sadness. So when combined with semaglutide treatment. You can see that CMT really prevents the lean mass breakeven increases. [indiscernible] its, resin into macro type pre-feeded beat and CMT firmer completely restore the new mass and content that massive reduction. [indiscernible] business. So we're looking at data biomarker at the end of the study, we saw no retilevels were in line with the reduction in [indiscernible]. We also observed a decrease in plasma for [indiscernible]. This is a [indiscernible] reflecting less fat circulating in the blood stream with no changes in cholesterol. So collectively, this shows the epitope to deliver all beneficial metrified profile.

Looking [indiscernible] we advanced 3D imaging platform, best and live resin microscopy. This technology provides using wanted to attain volume of individual muscles in the [indiscernible]. You've seen this approach. We exit the [indiscernible] increases total loss volume in the highly octane [indiscernible]. Both of monotherapy were important also in combination with [indiscernible]. This indicates that we then tie analyzed muscle tissue. [indiscernible] CMC has concisely is shown to improve project [indiscernible]. Here, we expect these filings using a nonactive [indiscernible] to analog in a rat model of clinic heart failure. In this model, [indiscernible] has increased by permanent placation has the left interior [indiscernible]. This creates impact in the left [indiscernible]. So operating and please control assembly.

1 month after in my induction, once the state impairment is fully established and tie bidding in black. We achieved lower [indiscernible] standard of care combination as soon [indiscernible]. Animals succeeded for [indiscernible], which shows the marked reduction in private [indiscernible] to the animals versus [indiscernible]. In this setting, we [indiscernible] a significantly improved product demonstrating its ability to also improve by a function. [indiscernible] preclinical finance because new CMC has a differentiated by high-quality [indiscernible] with improvements in key obesity [indiscernible]. So we're now [indiscernible] and we expect to start the clinical study in the first half of next year.

So now, Kristian, over to you for an update on the financial results.

Thank you, Louise. And as we said in the beginning, the first 9 months has been nothing but fantastic for Gubra. And we had a revenue in the discovering partnership business of above DKK 2 billion, of course, affected by the AbbVie deal and the upfront payment there. We're also increasing our cost as fully as expected as we drive a number of projects for in parallel, of course, the amylin and [indiscernible] in particular, over and above an extremely strong results for Gubra the first 9 months of this year.

That was the results for the D&P unit. Looking at our CRO business, we have a very strong position in metabolic and fibrotic diseases. And in '25 in particular, we have been building out the women's health area, which is a growing area of importance for Gubra that we will speak more about in the future. We, of course, have our established area, obesity, kidney, mesh and so on. But definitely, women's health is an area that we spend more and more money to build up. And as I said, we will speak more about this in the future. As we also spoke about, we have wide variety of customers from the smaller buying customers to the very large big pharma customers. And we cater to 15 out of the top 20 big pharma customers. I will comment shortly what we're seeing in the first 9 months in the market dynamics, and I'll take that on the next.

So again, coming back to comments earlier. We had an extremely high growth rate for the last couple of years. And in '23 and '24, we grew this -- the [indiscernible] service business by 30% organic growth in both years higher than our overall ambition to grow 10% annually. This year, we've seen a slight decline with down 5% in the first 9 months compared to the same period last year, primarily as we face some macroeconomic headwinds affecting the conditions for our small biotech companies, where they are taking longer time to place new studies. When we look out, we see some signs of improvement, and the funding conditions seems to have improved a bit [indiscernible] company. So we sense a bit of optimism when we're looking at 3 quarters ahead.

Looking at the costs. As I said, we're building up the women's health area, and this is something that we can establish a good decision within. When revenue goes down a bit, it, of course, affects our margins and be hovering around the 20% EBIT margin for the first 9 months. Talking about the outlook for the full year '25. We did a minor revision. And we said that previously, there will be slightly below and we lever in '24 for the CRO segment, and I would say we've [indiscernible] 10% below for the full year margins unchanged and also the function expectations to the cost in our discovery and partnership segment. So overall, again, reiterating a fantastic 9 months for Gubra and record results by all measures.

I will hand over to Markus now for concluding remarks.

Very good. So what should you watch for? I think Gubra is preparing for the next wave of growth to the expansion of our pipeline and increased [indiscernible] efforts. So certainly, [indiscernible] moving into the clinic is for us, I think, the driver, and we are confident that we are on the runner [indiscernible] difference in, say, the gross market. Also, in terms of strategic areas and [indiscernible] where we already have a very, very good stronghold. So we're looking into this right now and there will be more [indiscernible]. To deal is [indiscernible] a good deal for us that, of course, we want to expand our partnership building on the apartment listing and we will still focus on being peptide innovation house and on the edge on designing needs that we [indiscernible].

Now over on the innovation side, of course, also for our CRO, it's extremely important that the brand and the cutting edge of innovation technology. And since it will be very important in support of our [indiscernible] as well as our [indiscernible]. This also our strategic growth levers and [indiscernible] here, and we can now go to Q&A segment.

So operator, we are ready to take questions, please.

[Operator Instructions] The first question comes from Thomas Bowers from SEB.

The next question comes from [indiscernible] from Goldman Sachs.

So firstly, please, could you provide your perspective on the [indiscernible] data from Lilly yesterday? What are the implications do you think for GUBamy? And do you think it can show similar efficacy? And then secondly, what are your expectations for the non weight-lowering benefits for GUBamy and the amylin class? In particular, do you think there's potential for cardiovascular benefit, for example?

Thank you very much for those excellent questions. I'll this question to Louise.

Definitely. So thank you this question. So just on a general notice we usually refrain from commenting directly on clinical data from other companies, but from the -- for the overall amylin plus the data looks promising. We see a huge potential in the class of amylin to deliver clinically relevant weight loss, well in line with the recent published data.

So for the second question regarding did you talk about the cardiovascular benefits or what was it related to?

So just what your expectations are in terms of any non-weight lowering benefits, so cardiovascular would be kind of the first example of that. But in terms of any other impacts you expect from the Amylin class?

6 Yes. So one, expectation is that, of course, we will need to see the true value in the clinical studies, the [indiscernible] clinical studies, but on a general notice losing weight usually translate into an overall improved beneficial metabolic profile also on the cardiovascular side.

The next question comes from [ Rami O'Connor ] from Van Lanschot Kampen.

I have 2, if I may. The first, I was wondering how you expect the areas of NASH and kidney to develop. Is obesity still remain a contributor? Or is your focus on NASH is being made towards the [indiscernible]? And the second, with [indiscernible] are you able to provide some color on anything related to trial design, [Technical Difficulty]? And will you also be exploring cardiac as you're seeing those benefits in a cost savings?

Yes. So definitely. So regarding biggest continues to the CRO revenue then obesity continues to be a key driver for the revenue for the Gubra, of course, we also see a result from [indiscernible] and kidney, but we are constantly expanding on our service option. So as Kristian also alluded to, we are establishing a women's health as a new important area for us to make sure that we'll be more competitive with pipeline of services in the CRO business.

Regarding -- and I lost you a little on the line there on the second question, but I believe you were talking to the trial design for the UCN2 program? So from that perspective, we haven't disclosed much yet on the clinical performance, but of course, we want to explore as many options as possible with such an asset. But usually, the Phase I clinical studies, they are designed to explore safety and [indiscernible].

Yes. I think we can talk more in one of the next calls.

[Operator Instructions] The next question comes from Thomas Bowers from SEB.

So actually, I'm sorry if I'm repeating one question because I sort of missed a few minutes. But I just wanted to ask, first of all, on the CRO business. So in regards to U.S. customers, so with the current order book, would you consider that to be within the normal range to secure that 10% year-over-year growth? Or is there still some catching up to do here in the U.S.?

And then in regards to '26, I know, of course, you're not guiding yet, but should we expect some sort of a catch-up effect from those CRO clients in the U.S. coming back now? So is the order book is going to be a little bit bigger for '26? Or are you still going to stick to your to your 10% limit in order to prioritize D&P? And then I think there was a question also on [indiscernible], but I'll just ask in regards to the whole concept here on selectivity to the eminent receptor, is there anything that makes you think differently now in regards to targeting -- or being more sort of nonselective so both targeting [indiscernible] and amylin or is this still something that is up for grabs, so to say? So any comments here would be appreciated.

Thank you very much. First question goes to Kristian, and Louise will comment on the second.

Yes. So when we talk about the funding climate for biotech customers, I think we have a sense that, that is improving a bit and that impacts the order intake for our CRO business. We have an overall ambition to grow our CRO business by around 10% every year, and we overshoot at this several times during the last couple of years. And in certain years, there are some headwinds as we had this year but again coming up from a very high level in '24.

So I think we see a slight improvement to the -- to help smaller customers see their ability to finance new preclinical studies. Then we'll see when we come back with the annual report how we guide for next year. It is just to provide you a little bit of insight into the biotech customers, which is 1 segment in our CRO business. So we see a slight improvement there and we hope that will continue going into '26.

Yes. So thank you for the second question. It is an ongoing discussion in the field of the amylin biology. To remind you, ABBV-295 as a balanced profile on the amylin [indiscernible] just like net, amylin, we saw a very large result from the MAD study with an almost 10% weight loss delivered by [indiscernible] we see huge pretension in this asset. So no, we haven't changed our perspective on this.

Since there's no one left in the Q&A queue, I will now turn the call over to Gubra management for written questions.

Okay. I can see there are no written questions either. So, Markus?

Well runoff. Thank you very much for your time today. I really appreciate your interest and questions about Gubra, and I look forward to our next call next time. Thank you.

Markus.

After your first few months as CEO at Gubra, can you share some of your reflections and ambitions for the company?

Over the past few months, I've come to appreciate how unique Gubra really is, great Science, strong execution and a financial foundation, which is really solid. Something you rarely see in biotech. At the core of our strategy, there is a dual business model. On the one side, the Biotech unit, our core value driver; and on the other side, our CRO, a powerful enabler, which is setting us apart. Looking ahead, we will expand our pipeline and explore new high-value therapeutic areas also beyond obesity and metabolics and strengthen our technology and preclinical entities to support this growth.

My ambition for the company is clear. We will advance multiple programs into the clinic and expand our partnerships also with the blueprint we have from our recent deal with AbbVie on Amylin. We will further strengthen our leading position as a peptide-centric, disease-agnostic techbio company.

On the biotech business and the internal R&D pipeline, is there a particular asset you would like to highlight?

Yes. UCN2 is our next major project. It's a selective, a long-acting urocortin-2 analog designed for what we call healthy weight loss, reducing fat and at the same time, maintain or even increase lean muscle mass. In preclinical studies, UCN2 has shown impressive results. It prevents lean mass loss typically seen in GLP-1 treated patients. It also improves cardiorenal markers. So it's a great candidate for a potential combination therapy.

In the third quarter, we also confirmed that UCN2 can promote muscle growth using our advanced 3D imaging technology. So as the next step, we will enter first-in-human trials with UCN2, and we remain firmly on track to do that in the first half of 2026.

How did the business perform in Q3? And what's the outlook for the CRO?

Our CRO had enjoyed remarkable long-term growth, over 70% since 2022. In the first 9 months of this year, we have seen a small decline, about 5% compared to the same period last year. That's driven by the market environment, macroeconomic trends, less biotech funding. It's just creating longer decision cycles at our customers.

Having said this, we will continue to drive best-in-class quality and speed, stay close to our customers and let our CRO be a key enabler for our biotech and partnering strategy.

Do you have any final thoughts you would like to share with us today on Gubra's performance and outlook?

I'd like to emphasize the great value potential across our businesses and also, of course, the record year-end results we will deliver as a group in 2025. Over the first 9 months, we have delivered earnings of more than EUR 270 million, driven by an exceptional deal with AbbVie where we licensed our Amylin.

Looking ahead, I think Gubra is well positioned for the next wave of growth. I'm very excited to work with my great and passionate team to unlock the full potential of the company.