Gubra A S

Good day and welcome to the Goobra earnings release Q4 2024. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star, followed by the number one if you are listening via the phone, or submit via the Q&A box on the webcast page. And finally, I would like to advise all participants that this call is being recorded. Thank you. I'd now like to welcome Henrik Lowe, CEO, to begin the conference. Henrik, over to you.

Thank you very much, operator, and welcome to everyone on this call. Today we'll be presenting the Annual Report 2024, and I'm Henrik Lowe, I'm the CEO of Gruber, and I also have with me Louise Dalbury, our Chief Scientific Officer, and Christian Borbos, our Chief Financial Officer. So Gubra is a research powerhouse. We have a core research engine and we are specialized in preclinical research within metabolic diseases. This core research engine we can use to deliver research services, CRO, to external customers and the other part of the business, With DNP, that is where we are using the core research engine to advance our own internal pipeline programs. So we've been growing steadily over many years, actually 30% yearly revenue growth over a very long period of time. And now we are 260 colleagues. all gathered here at our site near Copenhagen, Denmark, apart from our colleagues in the Boston sales office. In the service business, we are servicing 16 out of top 20 pharma companies in the world. It's a testimony to the high quality and specialized expertise that we can deliver in our services. so in 2024 we experienced strong performance across gopro in the service business the cro we have a revenue growth of 31 percent and that is compared to the 20 to 15% growth that we were expecting in the beginning of the year. So a remarkable growth, and that is actually on top of another remarkable growth year back in 2023. We also saw very solid EBIT margins in the service business, 30%, and that also came in slightly higher than originally expected. For the pipeline part of the business, the DNP, we were expecting one to two new partnerships and we ended up making one new partnership. So that was also within expected range. And last but not least, last year we presented clinical results from the group AMI SAD phase one study and they were very encouraging and to our satisfaction. So we will get further into some of this today. I'm just there, I'm shifting slide. So some of the operational highlights of the year, as mentioned in the AMELIM program, we did release the SAD data in November. We have a multiple ascending dose study, which is progressing to plan. And we are now revealing that we will be giving some interim results from the MAD study in April 25, so in April this year. And that is a specification compared to previously announced where we said it will be in the first half of this year. But now we can reveal that it will be in April. Another pipeline program which is highly interesting we find is our UCN2 program for healthy weight loss. We are advancing it at speed and the preclinical talks is currently ongoing. And we are ramping up for a phase one study with this program late this year or early next year. As mentioned, we entered into a new partnership that was with Amelix. It's a very interesting partnership where we are together with our partner developing a novel long-acting GLP-1 receptor antagonist. So it's within the treatment of post-bariatric hypoglycemia and other rare diseases. And last but not least, as mentioned, a significant growth in the service business, 31% revenue growth, and primarily driven by a very strong interest in our obesity services and kidney-related services. And for the CRO business, we saw an EBIT that was up by 44%. year over year. In the annual report, we're also shedding some light to our new 2030 strategy. And I'll shed some light on a few aspects here. So in the pipeline and models part of Gubra, we are still very enthusiastic and ambitious. We have upped our ambitious expectations. So where we previously said we would have one to two fully owned programs in the clinic, we now say that we will aim for one to three fully owned programs in the clinic. Also, we are now saying that we will be developing one to two new flagship areas. And starting out, we will be looking into women's health, where we see a number of factors that makes this a very interesting area for us. We see a significant unmet need. We see a growing interest across the industry in And we also see a range of diseases where we can build on the knowledge and expertise that we already have in-house. So based on these factors, we expect it to be an area that can contribute in the future to both the service business and the pipeline business of Goobra. Another aspect which we are mentioning here is that for the core research engine, We have experienced this exciting growth over several years, and it means we have been expanding heavily here. And now we're actually saying that we will purposely limit the growth in CRO revenue that's going into the core research engine in 2025. So we will limit it to a growth of 10 to 20%. And that is because we would like to ensure that it stays as sharp and strong as possible to enable the future growth of Gubra and the future pushing forward of our pipeline assets. So we'll actually also go in and work a little bit on the balance, how we are using the core research engine. We'll be spending more resources on the pipeline in 2025 compared to previous years. And that's why we are, as mentioned, purposely limiting the influx of service studies to the core research. All right. I think that's enough on my part. I will hand over the word to Louise.

Thank you. So moving on to the drug discovery and partnership part of the business. And let me just start by saying here we're peptide experts. we discover novel peptide-based drug candidates either alone or with a partner. And all our work is done using an internal developed streamlined drug discovery platform. And using this platform, we can quickly develop a peptide hit molecule into a novel IP protected development candidate. So the platform takes advantage of AI and machine learning, which is combined with high throughput wet lab screening We screen multiple peptide libraries, thousands of peptides, and we use multi-parameter optimization, which saves time and enables the identification of better molecules faster. So the Streamline platform is key in the buildup of a pipeline. So here you see the group of pipeline in green, the internal programs. The most advanced one is an AMLIN program where we released positive top line results from the SAD study back in November. Next in line is a UCN2 program within high quality weight loss, also headed towards the clinic. Additionally, we have a range of other early stage programs. Then we have the ACIDs developed through various partnerships. You can see the first four here is with Boehringer Ingelheim, And you might recall the small asterisk next to the top program saying that it has been discontinued within obesity. New information here is that BI is exploring the potential for the compound in other disease area. We also have a collaboration with Hemat within bleeding disorders and with Amalix within the post bariatric hypoglycemia, the new collaboration. But let's take a closer look at some of these programs. starting with group AMI along acting amylin analog and group AMI is in development for weight management indication and could be positioned as both an alternative on addition to incutin-based treatment. Group AMI has a balanced receptor on the amylin and calcitonin receptors, just like native amylin, and it has a half-life compatible with once-weekly dosing. Importantly, Gupami is chemically and physically stable at neutral pH, allowing co-formulation with other anti-obesity agents. So in November, we released top-line phase 1A results for Gupami. The single ascending dose study was a very traditional dose escalation study, and doses covered range from 0.5 to 6 mg. It was a randomized study. double-blinded within cohorts, and placebo-controlled study, enrolling a total of 48 subjects. In this study, we showed that group AMI was very well tolerated with adverse events being predominantly GI-related, mild, and transient. Group AMI had a long half-life of 11 days, and a single dose of group AMI reduced body weight dose-dependently, and the effect was sustained throughout the study. So we are very excited pleased about this positive result, supporting further development of group AMI. So we are currently testing group AMI in the multiple ascending dose part of the study. The study outline is shown on the slide here. And in this part of the study, we're also including females. The study consists of two parts, a part A, where subjects are dosed for six weeks, two cohorts, and a part B, where subjects are dosed for 12 weeks, three cohorts. And it's from part A, the first two cohorts, where we're looking very much forward to present interim results in April. So moving on to another very exciting program in our pipeline. So this program builds on a new mechanism where we use long acting UCN2 analog to induce a muscle sparing weight loss. And this is interesting. Because with current weight management strategies, it's well acknowledged that lean mass accounts for 20 to 40% of the weight loss. And lean mass, it's bones and it's muscles. Therefore, we think it's time now to focus on the quality of the weight loss rather than just the quantity. By this, we mean that we want to maximize the loss of fat mass while preserving or even increasing lean mass. And then we want the potential for cardiorenal upside. In preclinical animal models, we have shown that we can obtain all this with a long-acting UCN2 analog, which holds potential to become the next generation of anti-obesity treatment. We have designed a selective UCN2 analog. It has excellent formulation properties and allometric scaling from data in mice, rats, and minipigs supports a once-weekly dosing profile in humans. So if we look at these data from a study conducted in diet-induced obese rats, you can see that by itself, the UCN2 analog doesn't change body weight much. But when we look at body composition, that's when we start to see the real changes here. You can see that the UCN2 analog increases lean mass and decreases fat mass. So basically, you can say that we're turning fat into muscles. You can also appreciate that other weight-lowing agents such as Imaclotype decreases both lean and fat mass. When we combine a UCN2 analog with weight-lowing agents such as Imaclotype, you can see that we can completely prevent the lean mass loss and drive the fat mass loss even further. So we are currently planning for clinical testing. We have initiated the non-clinical tox program and we plan to initiate a phase one clinical study late 25, early 26.