Welcome, and thank you for listening in on today's presentation of the top-line results from the GUBamy Phase I-A Single Ascending Dose Clinical Trial. So I'm Henrik Blou, and I'm the CEO of Gubra. And Gubra is a Copenhagen Nasdaq-listed company. And we are experts in preclinical research within metabolic and fibrotic diseases. And since our inception back in 2008, we have created a core preclinical research engine, which we use to provide preclinical research services to outside customers and to advance our internal pipeline programs. We are serving 16 out of the top 20 pharma companies in the world, among a lot of other clients. And more than half of our revenue in the service business is from customers in the U.S. And that is why we have a small sales team based in Boston. However, the remainder of my 250 colleagues are all based in Copenhagen, Denmark. Our pipeline, we have 11 peptide programs. Eight of these are within obesity. Today we will be focusing on the GUBamy Amylin program, which is the most advanced, not yet partnered program in our pipeline. Within weight management, obesity therapies, there are treatment options on the market today. However, there are still unmet needs. GUBamy has potential both in the form as a monotherapy, but also as part of a combination treatment regimen. The top-line results we present today show that in this trial, the GUBamy compound was well tolerated. It had a very long half-life. We also saw signs of early target engagement in the form of a sustained body weight loss. All this means that we see direct support for further developing the GUBamy program. Now I will leave the word to Gubra's Chief Scientific Officer, Louise Dalbøge, please. Thank you, Henrik. But let's just take a step back. I want to give you an introduction to amylin biology and explain why we're really excited about this asset and see a huge potential here. So amylin is an endogenous peptide hormone. It's produced in the pancreatic beta cells, and it's well established that amylin plays an important role in energy and glucose homeostasis. 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-1. This means that there is substantial potential of combining amylin with incretin-based therapies to drive weight loss even further. So despite having many beneficial properties, the amylin backbone has some inherent liabilities that make it unsuitable as a drug. It has a short half-life, and it fibrillates. Therefore, at Gubra, we have designed GUBamy. GUBamy circumvents all the undesired properties of the amylin backbone while maintaining the beneficial biological properties. GUBamy has been designed to have a balanced receptor profile on the amylin and calcitonin receptor, just like native amylin. Additionally, it has a very long half-life, compatible with once-weekly dosing in humans. Importantly, GUBamy is physically and chemically stable at neutral pH. This allows co-formulation with other anti-obesity agents. In preclinical animal models, we have shown that the body weight-lowering properties of amylin are also seen with GUBamy. Here, we see a very nice body weight reduction both alone, but also when combined with incretin-based therapy, we see a very nice additive weight loss. Finally, GUBamy has a very long patent exclusivity. Altogether, GUBamy holds potential to become the next generation of anti-obesity therapy. So now over to Mads Axelsen, our Chief Medical Officer. He will present the top-line result from the SAD study. Thank you, Louise. Today we are here to present the results from the SAD GUBamy study. We start out with the trial design. This is a very traditional dose escalation design, starting out with a low dose, 0.5 milligram, treating all subjects, evaluating safety before moving into the next dose cohort. The doses covered in this study are from 0.5 milligrams to six milligram. The study was a randomized double-blind within cohorts. In each cohort, two placebo subjects were included and six active. A total of eight subjects per cohort and 48 subjects in total. This is a subcutaneous injection of GUBamy. The study was executed at a site at a CRO in the U.K. We included males lean to overweight, but otherwise healthy. In the next slide, we have shown the subjects actually enrolled in the study. This is a table of all dosing groups, placebo, GUBamy from low dose to the highest dose, and showing the mean age across the dosing group. And they look very comparable across the dosing groups. As mentioned, all males included in the study. When we look at the body weight at baseline and the BMI, these are also similar across dosing groups and appear to be slightly overweight as a group as such. Importantly, none of the subjects enrolled in the study had diabetes or signs of diabetes. So the primary objective of the study is to look at safety and tolerability. And for that, we have looked at the treatment-emergent adverse events. This is shown on this table, again showing all the dosing groups. And in the first row, we show all treatment-emergent adverse events reported in the study. When we look on the second row, we see that the severity in these AEs are all mild. Apart from two in the 3.5 and six milligram doses, one was associated with a GI side effect. The other was not related to GI side effect. Importantly, no severe, no serious adverse events. And all subjects completed the study as planned. When we look into a little bit more details on the type of AEs that we captured in this study, GI side effect is known to be associated with anti-obesity therapy. And also here, we see that there is a tendency to more AEs in the higher dosing groups, starting out at the two milligram dose and then increasing with the numbers with the higher dose. When we look more specifically on the type of AEs, nausea was the most frequently reported one. We had a few cases of vomiting and a series of other GI-related side effects, also mainly in the higher dose groups. Interestingly, when we look at the metabolism AEs, which is the second most frequently reported group of AEs, decreased appetite was also reported in a dose-dependent manner, starting with the 3.5 milligram and increasing in number with the higher doses. As for other injectable, we also looked at the injection site reactions, and a majority of these were associated with pain and were also seen in the higher dose groups, probably associated with the higher volume that is delivered in the higher dose groups, so a dose-dependent GI side effect, nausea and vomiting, mild transient, and primarily reported at the higher doses. Importantly, also to mention here is that all AEs were resolved during the study, and a majority of these were resolved within a few days. The secondary endpoint in this study was the pharmacokinetics. And this is shown on this slide, where we have shown the PK curve from all doses, from low dose until the highest doses. And you can see that the maximum concentration and the area under the curve is increased with increasing doses, supporting the dose proportionality of the compound. When we look at the half-life, is the decline of the slope of the graph. You can also see that this seems to be almost parallel, confirming that the 270 hours of T half is consistent across the six dosing groups. A long half-life of 11 days suitable for once-weekly dosing. Finally, we go to the exploratory endpoint, looking at the pharmacodynamics. Here we show the change in body weight in percentage over time. This graph shows all the dosing groups. Placebo in black in the top, the three lowest dose group in bluish colors, and the three highest dose groups in the reddish colors. You can appreciate that there is a dose response with increasing weight loss, with increasing dosages for the full dose range. When we look at the placebo group alone compared to the three highest dose group, we see that there is a sustained weight loss throughout the six-week period. For the placebo group, we see a weight gain between 0.5% and 1% over the six-week period. For the three highest dosages, we see a weight loss already from day four, and the weight is sustained throughout the six-week period. The weight loss in the three highest dose groups goes from 1.8% - 3.2% throughout. So this concludes the results from the SAD study. I would just like to remind you that we also have a multiple ascending dose part of the study. The study design is shown on this slide. There's a part A and a part B. Part A is a six-week dosing of two dose levels without titration and a part B with titration and treatment for 12 weeks. Again, a randomized double-blind within-cohorts, placebo-controlled, including 52 subjects, and in this part of the study, we also include females in the study. This study was initiated with the first dose in September of this year. We expect to be able to present interim results from the part A in the first half of next year and complete the full study by end of 2025. So with that, the conclusion of the study, GUBamy dosed once in a dose range from 0.5 to six milligrams. GUBamy was well tolerated, with adverse events being predominantly GI-related. They were mild. They were transient. GUBamy had a favorable pharmacokinetic profile with a half-life of 11 days, supporting once-weekly dosing. A single dose of GUBamy reduced body weight dose-dependently. The effect was sustained for the duration of the six-week trial. Mean body weight reduction in all the high dose groups, 3.5-6 milligrams, reached approximately 3% during the six-week trial period, compared to a weight increase of approximately 1% in the placebo group. These results support further development of the GUBamy for a weight management indication, and as mentioned, the MAD trial is ongoing, with interim results expected in the first half of next year. Thank you so much for your attention. If you wish to ask a question, please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key six on your telephone keypad. The next question comes from Suzanne van Voorthuizen from VLK. Weight loss. Sorry, can you hear me? Now we can, Suzanne. Okay. Hi there. Congrats on the data. My first question relates to the weight loss graphs. It is interesting to see the curves and the sustained effect. And then I guess it depends a bit on what time point you look at. But do we understand correctly that the delta versus placebo is even a bit more than 4% at day 22? And would it be possible to indicate what that maximum delta is exactly? And then I have a follow-up. Hello, Mads Axelsen here. Thank you for your question, Suzanne. I think we gave kind of the average of the weight loss over time for the period. We haven't really looked at the specific time point, and what you are looking for is the placebo-corrected weight difference. Is that correctly understood? All right. Yeah. So I don't think we have that specific number as such. But I think our message is that we do see kind of a level of around 3% that is maintained throughout, as compared to the placebo, a slight increase of approximately 1%. So we have not been looking at the specific time points, with what is the maximum difference between the two. Got it. Thank you. And then my second question relates to the half-life of 11 days. Can you elaborate if you continue to see GUBamy as a once-weekly drug, or could this half-life potentially enable less frequent dosing? How should we think about this? And to what extent should we think that the half-life can benefit the tolerability profile in the future as well? Thank you. Yeah. Hi. Yeah. So it's correct that we have a very long half-life for GUBamy. 11 days is definitely compatible with a once-weekly dosing regimen. I think it would be fair to speculate if a different dosing regimen could be used for GUBamy. In the MAD study, we are going with once-weekly, but you could speculate that you could test out in other settings, right? What was the next? I'm sorry, the last part of the question. I missed that second. Yeah, the half-life effect on the tolerability profile. Yeah, that's correct, and that has definitely been discussed for other therapies, that if you have a low PK-to-PD ratio, so if you have a sustained exposure, then you can obtain better tolerability. Got it, and allow me to squeeze in one more. Henrik, can you remind us of your bargaining strategy for the asset? Thank you. Yeah, definitely. So of course, these data are key. We're very happy that this data set came out this nicely. And we continuously ensure to keep relevant parties informed. We have an opportunistic strategy here. We are discussing with various parties at any one time with regards to the pipeline assets we have. And when we see the right terms on the table, we will strike a deal. Thanks. Thank you for the next question. Thank you very much for the next question. From Martin Parkhøi from SEB. Please go ahead. Thanks, Martin Parkhøi. I just have to correct what popped into my eye, at least, that was how sustained the weight loss was. I read it in your press release, but it's still nice to see that as well. But can you explain a little bit why? Because we have to look at other studies, similar sizes, and also single dose injections, where we have seen weight losses going down to less than a half, and what is seen at peak, and also with a plasma half-life, which is roughly the same as yours. What do you believe that are the main reasons why you can sustain this as long as six weeks? Are there any possibility of it's just a chance finding? And then the second question, you of course alluded to that there's a dose-dependent effect on the side effect profile. But what on the efficacy profile? Because they are, and I understand that it is very few patients, but on the efficacy, the three high doses are very close to each other. Yeah. So maybe I'll go first with the body weight question here. So it's correct that we see sustained body weight throughout the study. It is a very impressive effect. And I would say that the reason for this, from our perspective, probably is the very long PK profile that we have with GUBamy, and it's something that we know that we have exposure for many days here. And it's something that we will explore further in clinical trials. And maybe I could add also to Louise's. I think you're kind of implying that we are reaching kind of the ceiling of the weight loss from a single dose. I think a repeated dose would probably tease out differences that may be in the three highest doses as well. So in a design that is in a trial that is designed to investigate efficacy, it probably will detail it out a little bit more than what we have today. Thank you. As a reminder, if you wish to ask a question, please dial pound key five on your telephone keypad. The next question comes from Morten Larsen from ABG Sundal Collier. Please go ahead. Hey, guys. Thanks for taking my question, and congrats on the data. A couple of questions from my side. One, probably a bigger picture. I was wondering if you could compare and contrast how you see GUBamy versus other amylins in development, and how you would expect these compare and contrast to play out in a potential partnering role, i.e., where would you be stronger? That's the first. Second, Henrik, how do you see these data play out in terms of impact on your corporate strategy, for example, about not funding beyond phase II-A? Let's start there. Thanks. Thank you very much. So yes, we do have a strategy of taking pipeline assets into the clinic and maximum to phase II-A. That is still the strategy of Gubra, and especially in an indication like this, I think it's important that the final steps towards the market, the very big trials, should be in the hands of a bigger player. So I think it suits nicely with our strategy here, and yeah, that's still the strategy of the company. With regards to your other question, the differentiating factor, I'll pass on the word to Louise. Yeah, definitely. So from our perspective, GUBamy is a very, very nice molecule. It has been designed to have some key features, meaning that it's soluble at neutral pH, and that means that we can co-formulate it with other anti-obesity agents. In addition, we have a very long half-life, 11 days, as shown here today. It's also really, really long. And we have long patent exclusivity as well with GUBamy, which is also a huge advantage. And finally, as also reported today here, we mainly see mild adverse events, even at higher doses, again suggesting a very favorable safety profile here. Thanks. If I can follow up with one more. If I'm being really nitty-gritty and nitpicking on the data, I may be able to see that one of your competitors has a faster onset of weight loss, i.e., after a few days. It may be nitpicking a little bit too much, but is this a fair assumption in what you're seeing? So I think it's within a few days, as you mentioned. I think as this product hits the market eventually, when it does, this will be a chronic treatment. So, the time, whether it's one or two days, I don't really think that is important for the patients treating with that. What may be more important is the tolerability profile and the sustained weight loss that we see across. So that is something that will be more clear from the clinical studies. But with the data we have now, that is how we look at the profile for GUBamy. Thanks. Maybe one more, if I may. On your adverse events and side effects, it looks like you're seeing more side effects in the 4.75 milligram group than in the six milligram. Is there something funny going on here, or how do you think about this effect? Yeah. So thank you for the question. I think it's so when you look at the number of events, they may be more in the 4.75. I think as we have concluded the study, we do see a tendency for a higher frequency in the higher doses. What is important here is when we do the repeated dose study and also when we introduce the titration, we believe, as also what has been seen with other incretins and amylines, that you can avoid at least the gastrointestinal side effects by introducing doses lower than your therapeutic dose. So that is the strategy that we will follow also in the MAD study to investigate how the tolerability would be with the titration step. So we will definitely start with a lower dose without the gastrointestinal side effect. That's how we will use these data to guide us in our titration schedule. Thanks. I have just one little bit of a cheeky one. Dare you try and guesstimate what kind of weight effect you may see over time percent in the petrelintide based on this? Sorry, could you repeat? Can we make any sort of extrapolation on what kind of weight loss you may see in the MAD trial based on what you've seen so far? So no, I don't think we should wander into that. We will, of course, in the MAD trial, primarily looking for safety and tolerability and pharmacokinetics in a regimen where we are dosing multiple times. And of course, also as an exploratory endpoint, be looking into weight loss. But I think it's too early days to start guessing where we could go. Thank you very much. There are no more questions at this time from the telephone lines. Okay. We have a few questions here on the written questions. So we have one question from Danske. It's the question I will read it up now. Do you target all three known amylin receptors, and any comments on the ratio between them? Yeah. So definitely, thank you for that question. So GUBamy has been designed to have a balanced receptor potency on the amylin and calcitonin receptors, just like native amylin. Okay. And then there's a follow-up question also on that. I understand you target the amylin and calcitonin in a one-to-one ratio, but are you targeting all? Yeah. We are targeting all amylin receptors, just like native amylin. Very good. I will move on to a few others. There's one asking, can you comment on why the weight loss peaks at day 22, but the half-life of the drug is 11 days? Yeah. And I think it's speaking a little bit into the very long duration of body weight loss that we see with GUBamy. Again, the half-life is 11 days, meaning that we actually have GUBamy on board for more than 11 days. So we will expect to see effects here while having the drug on board to a certain degree. Very good. Last but not least, it's a question if Gubra could imagine a Nasdaq listing in the U.S. I can take that one. And I mean, we listed one and a half years ago on Nasdaq Copenhagen. We're really pleased with that. And I mean, we take it from there. And if there's an opportunity to list in the U.S. in the future, we will make a decision on that. For now, we are quite pleased with being listed on Nasdaq Copenhagen. Okay. I think, oh, there's another question here before stopping here. How much higher do you plan to dose in the MAD trial? Yeah. Thank you for that question. I think the intent in the MAD, as I was also alluding to a little bit before, is to mitigate the gastrointestinal side effect and see if we can increase the dose in the repeated dose part of the trial. I cannot say what dose level we will get into. Data will show as we move into the MAD part of the study, but it is definitely part of the design that we will investigate higher doses in a repeated dose regimen. Okay. There's a last question also coming in here, so asking for a comparison between the GUBamy and the Petrelintide data in phase I-B trial part 2. It seems that Petrelintide has a stronger short-term weight loss effect. Yeah. Thank you for that question as well. And we will not be commenting on data from other trials. I think comparing between studies is definitely a difficult exercise, especially when it comes to small groups and so on. So focusing on our own data, we think it's a very strong data set that supports that we see a very consistent weight loss, and we see it's well tolerated. There's a very nice window where we can tolerate it, and there's an effect. And that's exactly what you're looking for in a therapy that should have all the legs to go to the market. So we are in all ways very pleased with the data set that we now have in our hands. Okay. There's still some questions coming in, and one question now that came in. Can you give any color on what a partnering agreement should look like from your side for GUBamy? Yes. So we have a long history of doing partnerships. It's been mainly in the preclinical phase. And now that we decided to move this into the clinics, and of course, we have built substantially more value into this program, and that should be reflected in a partnering agreement. However, we remain opportunistic, and we will evaluate various models for how a partnership could look like. Very good. It seems like there are no further questions unless there are more questions on the telephone line. I think we are ready to conclude here. Fantastic. So thank you, everyone, for listening in. And again, we are very pleased with the data set that we have presented to you today. And we are, of course, looking forward to the further development of this amylin asset. Thank you very much.