Gubra A/S ($GUBRA)
Earnings Call Transcript · May 6, 2026
Earnings Call Speaker Segments
Operator
OperatorWelcome to the conference call. [Operator Instructions]. Now I will hand the conference over to the speakers. Please go ahead.
Markus Rohrwild
ExecutivesGood 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.
Louise Dalboge
ExecutivesYes. 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.
Thomas Langenickel
ExecutivesYes. 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.
Zoe Johnson
ExecutivesThank 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.
Trine Hamann
ExecutivesThank 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.
Kristian Borbos
ExecutivesThank 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
Operator[Operator Instructions] The next question comes from Thomas Bowers from SEB.
Thomas Bowers
AnalystsA 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?
Markus Rohrwild
ExecutivesThank you very much, Thomas. And actually, Thomas will answer those questions.
Thomas Langenickel
ExecutivesYes. 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.
Thomas Bowers
AnalystsCan 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?
Thomas Langenickel
ExecutivesSo 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.
Operator
OperatorThe next question comes from Suzanne van Voorthuizen from Kempen.
Suzanne van Voorthuizen
AnalystsThis 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?
Markus Rohrwild
ExecutivesThank you very much, Suzanne. So Kristian will take the first question, Louise will take then second and the third.
Kristian Borbos
ExecutivesJust 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.
Louise Dalboge
ExecutivesYes. 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.
Operator
OperatorThe next question comes from Rajan Sharma from Goldman Sachs.
Rajan Sharma
AnalystsA 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?
Markus Rohrwild
ExecutivesThe question goes to Thomas.
Thomas Langenickel
ExecutivesYes. 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
Operator[Operator Instructions]
Kristian Borbos
ExecutivesOkay. 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.
Louise Dalboge
ExecutivesYes. 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.
Kristian Borbos
ExecutivesOkay. 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.
Markus Rohrwild
ExecutivesWell, 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.
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