Gubra A S

Welcome to the conference call. For the first part of the conference call, the participants will be in listen-only mode. During the questions and answers session, participants are able to ask questions by dialing pound key five on their telephone keypad. 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, GUPA operates via a business model involving three 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 COO, where we provide preclinical research services to external and internal customers. And we have also now established Cupra 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 Cupra 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 Herson at the DTU Science Park. So we are significantly expanding our lab facilities, which is beneficial to our internal discovery group, but as well as our COO, 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 medical officer and given the focus on clinical development of multiple assets in parallel in the future, this is an important step for the company. We have also progress on partner programs like MLX has selected a drug development candidate and is moving into IND enabling studies. That's good news. We have also launched a group of ventures. And Zoe Johnson has started in March to drive this forward. And in terms of our clinical pipeline, we have submitted a group UCM2 clinical trial application for an ambitious phase one to eight trial. And this is very exciting. This asset is a major opportunity for the company. On our partner asset, there is also great progress. ABV released ABVV295 Phase 1 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. going in line last week also announced that the triple agonist will move into phase two by mid of the year and also app we will proceed with the 295 phase two in q3 2026 so this is quite exciting we will have two goober discovered assets in phase two this year and also starting the phase one 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 the top talent, which has joined us in the first quarter. So in March, Grigio in February, and Thomas in January. We will not talk about our upgrade of digital strategy, but that 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 spent a moment talking about our business model because our three 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 three potential obesity blockbuster assets in clinical development, and we greatly benefit from the COO by doing most of our preclinical work internally. So there's great synergy and also scientific synergy between the units. The COO is a standalone commercial unit. It's operational 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 clinical development, 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. All together, we have value creation through faster pipeline progression, a broader and more resilient portfolio, and a structured capital allocation across the company. We also have different paths 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. The CEO plays in the preclinical discovery segment. The biotech unit covers everything from discovery to early clinical development. Phase 1b to phase 2a 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 prior clinical development and enabling studies till also phase two. This is I hand over to Our biotech leadership is our CSO, Louise.

Yeah, 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. At Guber, we're peptide experts. We discover novel peptide-based drug candidates, either alone or with a partner. And all our work is powered by our in-house technology. 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 is combined with high throughput Red Lab screening of multiple peptide libraries. We use multi-parameter optimization with such time and enables the identification of better molecules faster. So the strength of a streamlined drug discovery platform is reflected across both the internal and partner pipeline. UCN2, a proprietary muscle-preserving 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 Amelix, Camris and Hemap further validate the platform's reproducibility and track record of generating differentiated peptide acids across therapeutic areas. Since our last update, we have made important progress across the pipeline, including the CTA submission for UCM2 acid. We've also seen strong progression in our partner clinical stage obesity programs. AbbVie reported positive top-line phase 1 MAD results for ABPV295, and they plan to advance the program into phase 2 in Q3. In addition, Berger Ingelheim has decided to move the obesity triple agonist into phase 2 in mid-26. Together, this positions us to have two partner assets entering phase two in 26. So at Gubra, 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 three 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 while preserving or even increasing lean muscle mass. Differentiation will likely also come from improved tolerability, multi-target strategies, and the ability to address comorbidities. GroupRush pipeline is strategically positioned to meet these emerging trends. First, we have the long-acting amylin analog, ABBV295, now outlasted 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 treatments. 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 three receptors. And finally, we have the next in line UCN2 program. This program builds 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 lean 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 one 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 tolerability 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 1B study in obese patients aiming for higher female population. And the phase 2 program is expected to begin Q3 this year. 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 Y2 receptors to engage complementary pathways involved in body weight regulation. Following encouraging phase one results showing a meaningful weight loss and a favorable safety profile, Boehringer Ingelheim has decided to advance the program into phase two clinical development mid-year. We see this as further validation of the assets potential, as well as of GUPA's scientific innovation and partnering capabilities. With that overview, I'll now hand over to Thomas, a CDMO, who will provide further details on the UCN2 program.