Good day, and thank you for standing by. Welcome to the Zealand Pharma Webcast and Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you will need to press star one and one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one and one again. Please be advised that today's conference is being recorded. I would now like to turn the conference over to your first speaker today, Anna Krassowska, Vice President of Investor Relations and Corporate Communications. Please go ahead. Thank you. Welcome, and thank you for joining us today to discuss the top-line results announced earlier from the Phase 1B trial with our long-acting amylin analog, petrelintide. With me today to present and discuss the data are Adam Steensberg, President and Chief Executive Officer, and David Kendall, Chief Medical Officer. Our Chief Financial Officer, Henriette Wennicke, is also on the call today for the Q&A that will follow after the presentation. You can find the related company announcement on our website at zealandpharma.com. As described on Slide 2, I caution listeners that we will be making forward-looking statements that are subject to risks and uncertainties. Moving to Slide 3, I will now turn the call over to Adam Steensberg, President and CEO. Adam? Thank you, Anna, and thanks for everyone for joining the call today. Today is a very important day for Zealand Pharma. We are extremely pleased to report the top-line data from the Phase 1 16-week trial with petrelintide, which we are developing as a monotherapy for weight management. These data position petrelintide as a potential best-in-class amylin analog for weight management and reaffirm our conviction in petrelintide as an alternative to GLP-1-based therapies. With the potential for GLP-1-like weight loss and the very benign GI tolerability profile observed in trials today, we believe that petrelintide has the potential to become the backbone of therapy for weight management in the future. Moving to Slide 5 and our R&D pipeline, which includes truly differentiated obesity assets, two rare disease assets with best-in-class potential, both of which have PDUFA dates with the U.S. FDA in the fourth quarter, and two assets focused on chronic inflammation, which are both ready for first-in-human clinical trials. The focus of today's call will, of course, be on the Phase 1B top-line results with petrelintide. Turning to Slide 6. We believe that the obesity pandemic and the associated comorbidities represent the greatest healthcare challenge of our time. Obesity is associated with premature excessive death, and more than 220 complications and comorbidities can be ascribed to obesity, including serious chronic diseases like liver disease, cardiovascular disease, type 2 diabetes, kidney disease, Alzheimer. According to WHO, 2 billion people globally are now considered overweight and obese. In the U.S. alone, prevalence of overweight and obesity is rapidly approaching 50% of the population. Thus, the prevalence of obesity is still rising despite the launch of the first therapies to address this global healthcare challenge. Treatment rates globally are only approximately 2%-3% of the addressable population. Moving to slide 7. Considering the magnitude of the obesity pandemic, we believe there is a need for novel and alternative treatment options with a different mechanism of action than the GLP-1-based therapies approved today. We have seen the approval of the first successful rollout of the first two once-weekly GLP-1-based therapies to address this global healthcare challenge. In Phase 3 clinical trials of longer duration, they have demonstrated potential for 15%-21% mean weight loss in patients with obesity, and positive outcomes on several obesity-related comorbidities. On the flip side, GLP-1-based therapies are associated with a number of gastrointestinal adverse events, including nausea, vomiting, diarrhea, and constipation. Recent data suggest that up to 30% of patients with obesity on a GLP-1 treatment stop within a month before they reach target dose, and within one year, up to 60%-70% of obese patients withdraw from treatment. Thus, we believe there is a need for therapies that can help patients who cannot tolerate GLP-1-based therapies, or who would be looking for an alternative solution to maintain a weight loss. The 16-week data reported today significantly increases our confidence in the potential of petrelintide to represent an alternative to GLP-1-based therapies for the management of overweight, overweight and obesity. We are targeting GLP-1-like weight loss of 15%-20% in long-term Phase 3 clinical trials, with a potential for high quality weight loss, implying increased preservation of lean body mass. Importantly, petrelintide offers a differentiated mechanism of action, reducing food intake by increasing satiety for a different and potentially better patient experience. We are also confident that petrelintide has the potential for a significantly improved GI tolerability profile compared to GLP-1 receptor agonist, suggesting both lower frequency and milder severity of gastrointestinal adverse events, which is an important point of differentiation in weight maintenance. With that, let's move to Slide 9, as I will turn over the call to our Chief Medical Officer, David Kendall, who will present the top-line results. David? Thank you, Adam, and thank you all for joining us. I am extremely excited and pleased to share our top-line results from our 16-week Phase 1 trial of petrelintide. As outlined by Adam, amylin agonism offers a unique and distinct mechanism for achieving weight loss in people with overweight and obesity. Treatment with amylin agonists represent an exciting potential alternative to incretin-based therapies. Amylin agonism reduces body weight by enhancing satiety and restoring leptin sensitivity, a mechanism that is in contrast to the reduction in appetite and prospective food intake that occur with GLP-1-based therapies. Furthermore, non-clinical data have demonstrated that amylin agonists, including petrelintide, offer the potential to preserve lean body mass and therefore provide higher quality weight loss when compared to incretin-based treatments. In addition, both our own observations and clinical observation with other amylin analogs have demonstrated improvements in cardiovascular risk factors such as blood pressure, lipids, and markers of vascular inflammation without increasing heart rate, supporting the potential for improving cardiovascular risk. Our long-acting amylin analog, petrelintide, is a 36 amino acid acylated peptide based on the sequence of human amylin. Petrelintide has a 10-day half-life, making it suitable for weekly administration. The compound is stable at neutral pH, minimizes fibrillation, and can be both co-administered and co-formulated with other peptide-based therapies. In vitro studies have demonstrated that petrelintide activates both key amylin receptors and the closely related calcitonin receptor, a basic mechanism that we believe is important for the therapeutic effects of amylin analogs on body weight. We have previously presented data demonstrating that short-term treatment with lower doses of petrelintide can achieve weight loss of more than 5% in healthy, lean, and overweight and obese individuals. In this 6-week study, petrelintide was assessed to be very well tolerated, and all reported gastrointestinal adverse events were mild. These data were presented in full at Obesity Week 2023. Moving now to Slide 10 and the trial design of Part Two of our Phase 1B study. Petrelintide was evaluated in a randomized, double-blind, placebo-controlled Phase 1B trial, enrolling a total of 48 adults with overweight and obesity. Participants were randomized into one of three dose cohorts, assessing multiple ascending doses of petrelintide using a dose titration scheme or to placebo. Study medication was administered weekly for 16 weeks, followed by a 9-week follow-up period. Note that study participants randomized to the two higher dose cohorts received the maximum assigned maintenance dose for a period of only 6-8 weeks. Importantly, in this trial, there was no specific diet or activity intervention provided. Today, we are pleased to report the top-line data from an interim analysis for safety, tolerability, and change in body weight at 16 weeks at the end of the active treatment period. The full analysis of trial data will include an additional 2 months of post-treatment follow-up for safety, and full results from this trial are planned for presentation at an upcoming scientific congress. Moving now to Slide 11. Shown here is a summary of key baseline characteristics of the participants enrolled in this trial. In contrast to many weight loss studies previously reported, approximately 80% of the participants in this trial were male. Median age was 49 years, while median body weight was 92 kilograms, with a median BMI of 29 across the study participants. All groups were well-matched for baseline characteristics. On Slide 12, we show the reductions in body weight observed. The reduction in mean body weight across the three dose cohorts was 4.8%, 8.6%, and 8.3% from baseline after 16 weeks of treatment, while placebo treatment resulted in a mean body weight loss of 1.7%. Importantly, and consistent with our observations from earlier studies with petrelintide, all participants on active treatment lost weight during the 16 weeks of study, and the weight loss appeared to be on a continued downward trajectory throughout the active treatment period. In addition, review of data from individual participants supports that separation at the higher dose is possible with longer treatment duration in a larger study population. We find these data to be even more compelling in light of the fact that the study population was predominantly male with a relatively lower BMI, and these results were achieved in the absence of any background lifestyle modification. Moving now to Slide 13 and the tolerability profile. Petrelintide was assessed to be both safe and well-tolerated in the trial, with no serious or severe adverse events, and the safety profile observed was consistent with our earlier studies. All gastrointestinal or GI adverse events were mild, except for two moderate events, including nausea and vomiting, reported by one participant who discontinued treatment after the third dose. Notably, no other participants discontinued treatment due to adverse events, and no other participants reported vomiting, and there were only 2 reports of diarrhea, both of which were mild. Overall, nausea was reported by 16.7%-33.3% for active treatment groups and 16.7% with placebo treatment. In addition, only a low number of participants reported injection site reactions, all of which were mild. No anti-drug antibodies were observed. The tolerability profile reported in this trial further demonstrate the potential for an improved patient experience as compared to that reported in both clinical trials and with the clinical use of incretin-based therapies. In their totality, these results strongly reinforce our conviction that petrelintide has the potential to be an effective monotherapy as a treatment for overweight and obesity, and furthermore, offers the potential as an alternative to incretin-based therapies for both achieving and maintaining weight loss. We look forward to presenting the full results and analyses from part 2 of this multiple ascending dose trial at a scientific conference later this year. Turning to slide 14, these exciting and compelling data provide us the confidence and necessary information to rapidly progress our plans for initiation of a comprehensive Phase 2B trial of petrelintide monotherapy, which we expect to initiate in the second half of 2024. The draft study design is shown here. This larger trial, with longer treatment exposure, will enroll more than 400 adults with overweight or obesity, and will compare multiple doses of petrelintide or placebo over an estimated 42 weeks of treatment with up to 5 dosing arms. Consistent with other studies of treatments for overweight and obesity, the primary endpoint will be percentage change in body weight from baseline, and the study plans include a number of key secondary and exploratory endpoints, including assessments of body composition. We very much look forward to advancing the development of this exciting asset, and we truly believe that petrelintide offers the unique opportunity to establish a new class of standalone therapies for the treatment of overweight and obesity. And before concluding, I would like to express our thanks to the devoted study team, the investigators, and most importantly, to the volunteers who participated in this study. We are indebted to all of these individuals for the execution of this trial and look forward to progressing petrelintide development in the months and years ahead. Moving now to Slide 16, I would like to turn the call back to Adam for concluding remarks. Thank you, David. Let me put the 16-week data into a bit of context. We believe petrelintide, based on its molecular specific attributes and the clinical data reported in the Phase 1B multiple ascending dose trial, holds potential as a best-in-class amylin analog that could become a leading backbone therapy for future weight management. With all the caveats for indirect cross trial comparisons, including differences in trial designs and baseline characteristics, the 16-week data further increases our confidence that with Phase 2 and 3 trials of longer duration, we will achieve our target product profile of 15%-20% mean weight loss, and thus represent a clear alternative to GLP-1-based therapies. We look very much forward to initiating the comprehensive Phase 2B trial with petrelintide in the second half of 2024, while we will continue to increase our investment in CMC upscaling and clinical trials to further explore the potential of petrelintide in obesity and related comorbidities. Turning to slide 17, for a brief summary of the target product profile of petrelintide. In addition to the potential of 15%-20% mean weight loss in trials of longer duration, as well as the potential for preservation of muscle mass, which we'll learn more about in our Phase 2B trial, petrelintide offers the differentiation mechanism of action that reduces food intake by restoring sensitivity to leptin and increasing satiety, in contrast to GLP-1 receptor agonist that suppresses appetite. Amylin agonism is the first non-incretin that has demonstrated potential as a monotherapy for GLP-1- like weight loss. Petrelintide also offers potential for significantly improved GI tolerability, which would be a very important point of differentiation, both for the proportion of people with overweight and obesity who cannot tolerate a GLP-1, but also for people who would simply be like, be looking to try something else. Remember that in today's world, despite the generally low GLP-1 treatment persistence, there are no alternatives yet. With that, I would like to thank you all and will now turn over the call to the operator for questions. Thank you. To ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. We will now go to your first question. One moment, please. Your first question comes from the line of Julian Harrison from BTIG. Please go ahead. Hi, congratulations on these data, and thank you for taking my questions. I'm curious if there was any time-dependent trend in the nausea adverse events. Did they happen earlier on, and resolve, from there, or was the timing more sporadic? Yeah, Julian, this is David. Thanks for your question and the kind congratulations. The nausea trend was, in fact, that the majority of events were occurred early in the treatment and dose escalation phase. And in fact, the vast majority were transient, and there was a significant decrease in the reported rates of nausea over the course of treatment. So, a pattern that, again, further, I think exemplifies the tolerability profile that we have at least postulated, and certainly one that, for us represents, a very mild representation of nausea as a potential adverse event. Excellent. Thank you. And then two forward-looking questions, if I may. I'm curious, had this study been longer, at what point would you have expected efficacy to plateau? And then also, any comments with regards to expectations for body composition results in future readouts, that'd be greatly appreciated. Thank you. And maybe, this is Adam, I'll just start by addressing your last question, and turn over to David for the first one. I mean, I would say the preclinical evidence for preservation of muscle mass is really compelling and very strong observations, not only done with the petrelintide, but also across other amylin analogs. So it is something that we can say we have high expectations for and something we'll explore thoroughly in the Phase 2B study. And clearly something that could help further differentiate this opportunity as, not only you can say increasing the energy, increasing the muscle mass could be of health benefits, but also supporting increased resting energy metabolism, and thus, a more, you can say, pleasant way of maintaining your, your, your weight loss. David, maybe you wanna address the first question? Yeah, and in regards to your question or comment about plateau in clinical response, based on the data we've seen both in this study and the previous studies, we've seen no evidence of an early plateau in the treatment response. And as has been reported with cagrilintide and was seen previously with pramlintide, we would anticipate progressive weight loss over a period in excess of one year. Obviously, the Phase 2B that we have outlined will give us a further look at this over approximately one year of treatment. But as you likely know, the regulatory requirements now provide an opportunity to look out beyond 76 weeks of therapy. So where that plateau may occur, is, at least based on available evidence, likely at a year or beyond, and we would anticipate something very similar for petrelintide. Thank you. That's very helpful. Congrats again. Thanks. Thank you. Thank you. We will now take your next question. Your next question comes from the line of Michael Novod from Nordea. Please go ahead. Thank you very much. Michael Novod from Nordea. Sorry, there's some noise. I'm in an airport. A couple of questions from my side as well. First of all, can you go into detail around whether you'll be able to take sort of, dosing, somewhat, higher? Of course, we don't know your highest dose yet, but, looking at the Phase 2B, it's very comprehensive on the dosing side. Maybe a bit of details on whether you can actually take dosing, higher than what we're seeing, currently. And then, secondly, is there any rationale for the low, BMI? The BMI 29 is rather low, especially given the enrollment criteria going up much higher. Any rationale behind why you ended up around 29? And then lastly, is it fair to assume, also regarding muscle mass preservation, the link between calcitonin receptors and insulin sensitivity, so thereby also explaining, part of the potential rationale around muscle mass preservation? Thank you for your questions, Michael. I will start, and then David will provide further insight. As David mentioned also, with the higher doses, and as you can see from the data, then the two high doses, which are both very high doses, they achieve similar degree of weight loss in this study of 16 weeks duration. But there was also a clear trend, I would say, when you start to explore individual patient trends, that the highest of those doses would provide more weight loss with time. As we have also discussed previously, then we are actually at the max anticipated dose based on our tox exposure. So, I would say we have achieved very high doses that would not prevail us from, or prevent us from, actually going higher in later studies. But I think it's fair to say with where we are right now, we actually think we are in the relevant dosing span, and feel very confident to move into a Phase 2B with the current doses. As David also said before, we would expect you can say continuous weight loss, and also dose separations among the 2 higher doses in with longer drug duration. Then, David, maybe over to you on the BMI question and the muscle preservation versus the 2 receptors then. Yeah, and I'll add, Michael, thanks for your questions. That, the two doses you see as dose two and dose three are really high and highest, given where we started with part one of the study. But to your BMI question, you know, in this small study, we did not stratify for baseline BMI, and, you know, I will say it is in some ways, just the fortune of a small single-centered trial where the lower BMIs and the male preponderance, were observed. Neither were stratified in this study. My own thoughts is, you know, despite that, if anything, those characteristics may have muted the responses we see, and while we're quite pleased with the responses observed, other than the luck of randomization in small trials, and that BMI was consistent across the three treatment groups and placebo. Finally, your question about muscle mass, insulin sensitivity, and the role of calcitonin receptor versus the amylin, particularly the amylin one and three receptors. I think I'll stick with my party line that our understanding of amylin receptor biology is still in its infancy in many ways. But, based on the data we've seen, and understanding of the relationship between the two key amylin receptors and calcitonin, that all three are critical components of the weight effects of amylin agonists. Whether that preservation of muscle mass and the associated improvements in insulin sensitivity are related to one, two, or all three of those receptors, I think remains a part of our ongoing exploratory discovery work. So more data to follow would be what I would say on the latter. Thank you. Congrats again. It's really nice data. Thank you. Thank you. Your next question comes from the line of Prakhar Agrawal from Cantor Fitzgerald. Please go ahead. Hi. Congrats on the data, and, thanks for taking my question. So, on the baselines, you highlighted the high percentage of males, but most of the data for women showing better weight loss than males is from GLP-1 drugs. So I'm just curious as to, does the same trend hold for amylin as well? And does your prior data from part one or cagrilintide support this theory? And I had a couple of follow-ups. Yeah, thanks, Prakhar. I'll take that. Certainly the evidence does support that outside of GLP-1-based therapies, that weight loss in women is as great or greater than in men. And certainly, at least in the small numbers of subjects we observed in this trial, the women who were randomized to each of the three active treatment arms were the ones who were at the high end of the weight loss. So it bears true in our early experience for petrelintide, and I think will likely bear true for other weight loss therapies. And obviously, that will go into planning and stratification for our population for the Phase 2 study, so we get a much fairer representation of the effect in both men and women. Got it. Thank you. And just a couple of more questions. What was the magnitude of injection site reactions? I think you had that in mind, but at this point, do you think that the injection site reactions are differentiated versus cagrilintide? And lastly, any color on metabolic parameters, and do you think it's comparable or better than GLP-1 monotherapy? The reason I ask is these will be important if you want to develop, amylin as a monotherapy, given the outcomes benefit seen with GLP-1 drugs. Thank you, and congrats on the data. Yeah, thank you for that question. I can confirm that the, you can say, the frequency and also the severity of injection-site reactions were really low and mild. So we were really, you can say, confirming also our observations from the six-week study. So these are really low numbers of injection-site reactions. There were, you can say, one or two subjects who were actually, you can say, reporting most of those. So, so you can say on an overall, you can say, cohort, it was, I would say, impressively low numbers. So, so you can say, perhaps it also goes hand in hand with the fact that you can see from our release that we did also not observe any anti-drug antibodies. So we really feel that perhaps the, you can say, the construct of the petrelintide being able to formulate that neutral pH is something that is supporting, you can say, the observation of very low numbers of injection site reactions and also the absence, at least so far, of anti-drug antibodies. David, any further? Yeah, I'll reemphasize what Adam said. I mean, the preponderance of the reactions were reported by two individuals, and a mild was the grading of all of them. So I would say qualitatively, certainly, consistent with what we would call very low rates of injection site reactions. In terms of your question, Prakhar, on metabolic parameters, obviously, we have additional analyses to be completed from this data set. You're getting top lines, and we will begin exploring once the full safety data set is closed out in the next few weeks. But suffice it to say that, you know, metabolic parameters, including other measures of cardiovascular risk, like blood pressure, heart rate, will be part of our subsequent data disclosures, and really important information, to your point, to demonstrate the potential for protection beyond simple weight reduction. So more to follow, Prakhar. Thank you. Thank you. We will now go to our next question. Your next question comes from the line of Suzanne van Voorthuizen from Kempen. Please go ahead. Hi, team. Congrats on the data, and thanks for taking my questions. Firstly, on the dose levels, you are not disclosing yet, but you're saying you're within the relevant therapeutic band. So I was wondering for the Phase 2B, how those 5 dose levels differ from each other, if it's more in between doses or if there are other differences like frequency or titration. And my second question is on partnering, if you can elaborate once more on your thinking around the potential partnering of petrelintide and how this data set feeds into your thought process. Thank you. Thank you, Suzanne. Maybe I'll just start with the partnering discussions. We have been, I think, very clear that, as you can imagine, there is significant, and I think everybody understands that there is significant interest in this space, and our ultimate goal is also to find a very committed partner who, just as us, would see petrelintide as potential future alternative to the GLP-1 based therapies, and with the data that we have at hand here, also something that could actually form the backbone of future management of obesity. With the data at hand, we also have been very clear that we will have more, you can say, progress discussions with some potential partners to see if we have a shared ambition for the product. Because, you know, at least before we approach Phase 3, we see, of course, a clear need to partner, to have somebody who can that can support us in a global reach, somebody who can help with investments in manufacturing for which will be quite significant investments in, if you are developing something that could become a leading therapy for weight management. So, having said that, we also, as we have communicated on this call, are very, very, you can say, committed and also firmly believe that we have all the skills to push this molecule forward. So, but in the next Phase, into Phase 2 B, and I will just remind everyone that we have, you can say, a long history in this space, including having taken other products all the way to the market. It's with a lot of confidence we move forward, but it's also with a clear ambition of finding a partner, when time is right. Then I'll hand over to you, David, for the question on the Phase 2B trial design. Thank you, Adam, and thanks, Suzanne. As you can see from the draft study construct, there are multiple dose arms proposed or at least available to us. I think, as Adam alluded to earlier, we certainly feel like we have the opportunity to extend this to the higher doses that we've assessed, and that pushes us to the limits we think of the appropriate high dose of the petrelintide that could be the most effective. But that does not mean we have yet, you know, had these data in hand long enough to fully assess, and then discuss with regulatory authorities the specific doses that we will go with. But, I think suffice it to say, that we will seek to evaluate all, but certainly these higher and highest doses, in Phase 3. The titration scheme, same set of considerations, meaning we wanna make this clinically relevant. Is faster, better, or should it fit with usual clinical practice? As you can hear from the tolerability profile, there is little need to make major adjustments in the titration scheme simply for tolerability, but if that allows us to achieve the higher doses even more, safely and with even greater tolerability, we will certainly take that under consideration as we rapidly progress our plans to complete the Phase 2 protocol. Great. Thank you. Thank you. Once again, if you would like to ask a question, please press star one oh one on your telephone keypad. We will now go to the next question. Your next question comes from the line of Lucy Codrington from Jefferies. Please go ahead. Hi, thank you for taking my question. Just a few left. Just firstly, I wonder if you can tell us in which dose cohort the patient that discontinued treatment was, and any indication as to why this patient may have been unable to tolerate when everyone else seemed to tolerate it so well? Secondly, just to clarify, the BMI of 29, the initial slides say median, but then the final, the comparative slide says mean. So I just wanted to check, is the mean and median both 29? And then for the Phase 2B, is the plan to include lifestyle interventions for the Phase 2B study, or are you planning to have a similar kind of clean trial for the Phase 2B? And if so, what's the rationale for that? Mm-hmm. Yeah, I think I'll stop there. Thank you. Thank you, Lucy, and I'll try to take them one at a time. If I miss components, Adam will hopefully fill the gaps. As regards the single subject who discontinued, that individual received a total of three doses, so the starting dose and one escalation, but actually had the symptoms reported as mild at the first injection, but those continued. And after the third injection, in the highest dose cohort, chose to discontinue. A couple of key components to understand, this individual remained at relatively lower doses at the time they discontinued, but did start at a slightly higher starting dose than we had built into the other dose cohorts. So, it you know, I hope taught us a fair amount, even though it's 1 subject, and obviously no other subjects reported anything similar or discontinued due to GI side effects or adverse events related to treatment. The weight median and mean, I can simply say they are the same. The lifestyle intervention, yes, we do anticipate in Phase 2B building in diet and activity recommendations into Phase 2B, as is recommended by the regulatory authorities. Given that this was a short proof of concept and dose and safety and tolerability study, it was not built in as essential in Phase 1B, but will be included in Phase 2B. Brilliant. Thank you so much. Thanks much. Thank you. There are currently no further questions. I will hand the call back to Adam Steensberg. Thank you. With that, we would like to thank all for attending and for your questions. We look very much forward to future announcements and updates. Have a good evening. Thank you. That concludes today's conference call. Thank you for participating. You may now disconnect.