Gubra A S

Thank you for standing by. My name is Gail, and I will be your operator for today. At this time, I would like to welcome each and every one of you to the group first quarter 2025 earnings release. All lines have been placed on mute to prevent any background noise. After the speech 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 on your telephone keypad. If you would like to withdraw your question, kindly press star one again. Thank you. It is now my pleasure to turn today's call over to Gubre to start the presentation. Please go ahead.

Thank you very much, Operator. It's our pleasure today to present first quarter results for you. Starting out, GUPRA is a hybrid business model company. We are experts in preclinical research into metabolic disease and neighboring scientific areas. We have built a core research accelerator, meaning we have all the labs and testing facilities in-house in order to progress preclinical programs. And this core research accelerator we use to provide services to external clients as well as to mature our internal research programs so that is the cro business the external clients and the pipeline business the dnp business for the internal programs Today we are roughly 270 colleagues and in the service part of Goobra, we're working with a long list of various clients, 16 out of top 20 pharma companies in the world either are or have been clients of Goobra. So diving into the update from the recent quarter, The biggest piece of news was, of course, our landmark agreement with AbbVie on the Group AMI Ameline program. According to the terms of the agreement, we are granting AbbVie a global right to develop and commercialize Group AMI for various treatments, but of course, especially with a focus on obesity treatment. For the economics of the deal, they are quite significant and they are giving substantial economic freedom to Gubra. We have received $350 million in the upfront payment, and there is a milestone package of 1.875 billion as part of the deal, as well as tiered royalties on net sales. Also, In early April, we presented interim data from the ongoing multiple ascending dose trial. And there we could present the top line data from the first two cohorts. They confirmed what we did see in the single ascending dose part of the trial, generally Gubami was very safe. It was well tolerated. We saw the only expected, mainly GI related adverse events, and they were generally mild. Also, we did see a very interesting weight loss when we treated with Gubami for six weeks. and the weight gain in the placebo group was approximately two percent whereas the weight loss in the two milligram treatment group was approximately minus seven point eight percent so an almost ten percent difference between placebo and active also we have a new data in the ucn2 program that's our next in line obesity treatment And the dataset that we now have is confirming the previous findings that using UCN2, you can actually answer the weight loss that you get with current weight management treatments so that it is a loss of pure fat mass and no longer a loss of lean body mass. Furthermore, we saw in this data set that if you have been on one of the current treatments and lost some lean body mass, we can actually restore the lean body mass that was lost. So a super exciting data set, and we will also be presenting some more details from that today. Also today in the quarterly update, we give numbers for the service business, the CRO business. We saw a revenue in the CRO business of 51 million DKK, which is slightly below the revenue that we saw in the same period last year. We generally experience solid interest from our clients. So especially in Europe, that is the case. Going on to the pipeline, just a brief look at the pipeline. Currently, we have an impressive seven partnerships ongoing with the last edition of the EV partnership. Also, we still have five Unpartnered programs, as you can see, UCN2 being the most advanced of these, and also we are preparing this for first in-man study, which we expect to start early next year. And just a slide here on the ADVI licensing deal. As mentioned, according to the terms of the agreement, we grant a global license to ADVI for the further development and commercialization of the Group AMI Amilin program. In the deal terms, we received US$350 million upfront. We have received that. And also, there is a milestone package which can amount to 1.875 billion US dollars. On top of that, we will be receiving tiered royalties on net sales. So with this, I will hand over the word to Gubra CSO Louise Dahlberg.

Thank you, Henrik. And now let's dive into some of our programs. Starting with the long-acting amylin analog, formerly known as GUP-AMY. And GUP-AMY is in development for weight management indication and could be positioned as both an alternative on addition to incutin-based. Of key differentiating features, GUP-AMY has a balanced receptor profile on the amylin and calcitonin receptors, just like native amylin. It has an exceptionally long half-life of 11 days. And GUP-AMY has been designed to be chemically and physically stable at neutral pH. This allows co-formulation with other anti-obesity agents. So GUP-AMY is currently being tested in a phase one multiple ascending dose study. The trial design is shown on this slide. The study is a typically randomized, double-blinded, placebo-controlled study enrolling both males and females. The study has two parts. Part A consisting of two cohorts receiving once weekly treatment for six weeks. This part has now been completed. Then there's part B, testing higher doses during a longer treatment period. This part is ongoing and progressing as planned. From part A, we announced strong interim clinical results here in April. The data confirmed the general picture from the SAD study with a high degree of consistency within cohorts. The study showed that group AMI was well tolerated with adverse events being predominantly GI-related mild and consistent with the SAD study. Group AMI demonstrated a remarkable dose-dependent weight loss. Mean weight loss in the 2 mg cohort was 7.8%, compared to weight gain in the placebo arm of 2% on day 43. The study also confirmed the favorable half-life of 11 days. So we're very excited about these positive results, which further supports the development of Group AMI for weight management indication and position Group AMI as best in class. So besides AMALYN, we're equally excited about our next in line internal obesity program. It's focused on high quality weight loss and it builds on a new mechanism using a long acting UCN2 analog designed to promote fat mass loss while preserving lean muscle mass. And this focus is critical because current weight loss strategies, lean mass typically account for 20 to 40% of the weight loss. We believe. The time has come now to focus on the quality of the weight loss and not just the quantity as a key differentiating factor for the next generation of obesity treatment. So here we're talking about maximizing the loss of fat mass while preserving or even increasing lean mass. In preclinical studies, our UCN2 analog have shown the ability to deliver this improved weight loss profile, along with cardiovenial benefits. So we have designed a very nice molecule, a selective UCN2 analog, excellent formulation properties, and allometric scaling from animals supports a once-weekly dosing profile in humans. In earlier studies in obese rats, We have shown that UCN2 combined with other weight lowering agents enhances fat mass loss while fully preventing lean mass loss typically induced by these agents. We've now extended these findings using much older obese rats treated over a substantially longer period to better mimic an older obese population. The study aimed to one, confirm potential of UCN2 to increase lean mass and reduce fat mass in older animals, and to assess if we can reverse lean mass loss induced by prior semaglutide treatment. And the results are striking. So UCN2 alone, as shown in green, modestly affects body weight, but significantly improves body composition. Semaglutide shown in dark purple, reduces both fat and lean mass. When combined with semaclutide treatment, as shown in blue, UCN2 fully prevents the lean mass loss. It even increases lean mass, and it drives fat mass even further. And in semaclutide pretreated rats, adding UCN2 from week three, as shown in pink, completely restored the lost lean mass and potentiated fat mass reduction. So this highlights UCN2's potential as both a protective and a restorative agent in combination treatment. So we're currently advancing UCN2 for the clinic. Initially, we discussed a 12-week study period, but we now are planning to extend it to 16 weeks And the primary objective is, of course, as always, safety and PICO. And we expect to initiate the phase one study early 2026.

Thank you, Louise. And just a few words on the financial, starting with the discovering partnership business. So the revenue was up slightly, but please bear in mind that the upfront payment that That follows the successful closure of the transaction, which happened here in Q2. So that does not feature in the Q1 account. And again, a very substantial amount with 350 million Danish, sorry, million dollars equivalent to 2.4 billion Danish, right? And you can also see the total costs are going up. That is as expected. And it's that we're driving now two programs in parallel, both Ameling and the non-clinical study. So that is fully as expected. Turning to the CRO business, we saw a slight decline in revenue. Sometimes there are little small differences between quarters. We still see a sound And when you have a large fixed cost base, as you have with salaries, that's the main cost component in the CRO business. Then, of course, we also saw a decline in EBIT. Turning to the outlook for the full year, we maintain that. And again, to reiterate for the CRO business, we see a sound order situation, and especially in Europe. and also for the dmp business where we have the cost guidance that is unchanged with that i'll leave the word over to the operator and we can take questions time i would like to remind everyone that in order to ask a question press start and the number one on your telephone keypad

We will pause for just a moment to compile the Q&A roster. Okay, so your first question comes from the line of Suzanne Van Verthuizen with Kempin. Please go ahead.

Hello, team. Thanks a lot for taking my question. This is Chiara Montironi on behalf of Suzanne from Kempin. So given the successful closure of the partnership with AbbVie, We were curious to know how you intend to use the upfront cash and potential milestones in the future. And if I may ask a second question, if you could provide more color on the Q1 numbers for the CRO business, if you see any seasonality or anything like that. Thanks a lot.

Thank you very much for the questions. Starting out, use of proceeds from the from the deal and allocation of capital. So we are, of course, in a very lucky situation with significant freedom for the company. And we are currently evaluating carefully all these possibilities. And we are still investing resources, analyzing M&A opportunities. We are also using resources looking into various areas where we can expand our pipeline or our service offerings, our disease area focus, and generally assessing the various opportunities for us to develop the company. So there is no specific new part to our communication at this point in time. We are still evaluating these new opportunities together with the Board of Groups. When it comes to the CRO revenue, we, as mentioned, still experience solid demand, especially from Europe. We see a bit of longer decision times from US-based companies. If that is just random or if it's a signal, it's difficult to say this soon. I would say we are not expecting this to influence the full year result of the service business. And we maintain our outlook for the year where we are looking to attend to a 20% growth.

Thanks a lot.

Once again, I would like to remind everyone that if you want to ask a question, press star on the telephone key. It seems that we don't have any questions now, and I would like to turn the call over to Gubra for the closing remarks. Please go ahead.

Thank you very much for listening in on this Q1 update from Gubra. We are looking forward to reconnecting again once we have the next quarterly update. Thank you.

to everyone that concludes today's call you may not all disconnect have a nice day ahead