Zealand Pharma A/S

Welcome and thank you for joining us today to discuss Zeeland's results for the first quarter of 2024. With me today are the following members of Zeeland's management team. Adam Steenspert, President and Chief Executive Officer, Henrietta Winnecke, Chief Financial Officer, and David Kendall, Chief Medical Officer. You can also find the related company announcement and interim report on our website at zeelandpharma.com. As described on slide two, I caution listeners that we will be making forward-looking statements that are subject to risks and uncertainties. Moving to slide three, I will turn the call over to Adam Steensberg, President and CEO. Adam?

Thank you, Anna, and thanks to everyone for joining today. I'm very pleased with the performance of our business in the first month of 24. The progress we have made sets us up for an extremely exciting next few months with key clinical results from all our programs targeting obesity and continuous productive interactions with the FDA on our two rare disease programs. We have completed the phase 1B multiple ascending dose trial with protrinitide and the investigator-led dream trial with dapiglutide. Both programs are on track for top-line results here in the second quarter. For betrinotype, we aim to develop this molecule as an alternative to the GLV-1-based therapies for weight loss and, importantly, weight maintenance, as we believe the specific mode of action could provide a better patient experience and address some of the shortcomings associated with GLV-1-based therapies. With dapiglutide, we have a truly differentiated GLP-1 containing molecule designed to provide significant weight loss with the added potential to address the low-grade inflammation associated with metabolic diseases. Through the DREAM trial, we expect to mainly gain mechanistic insights into the effects of the GLP-1 and GLP-2 receptor components. as this trial only included lower doses of dabigrutide and thus will be less informative on the weight loss potential. In the second half of the year, however, we expect top-line data from a 13-week dose titration trial investigating significantly higher doses of dabigrutide. In February, our partner, Berner Ingelheim, reported groundbreaking top-line results from a Phase II trial with servilutide in mesh, providing evidence of effect on fibrosis and thus a clear differentiation that positions Cervulotide as a potential future leading incretin-based weight loss medication. Results from this trial will be presented at the ESO Congress here in early June. In rare diseases, we now have PDUVA goal dates for both dasyclogon in congenital hyperinsulinism and for plipactotide in short bowel syndrome in the fourth quarter. Lastly, we significantly strengthened our balance sheet through a private placement with two renowned international investors in early January, securing a runway into 2027. Moving to slide four. With the strong start of the year, we remain on track to deliver on our key priorities for 2024. We look forward to important clinical results for both quaterniontide and dabiglutide that we anticipate will position us to advance into large comprehensive Phase IIb trials and thus significantly expand our efforts towards developing the next generation of obesity treatments to address what we believe is the largest healthcare challenge we have seen in modern times. For the past year, we have already made significant investments into the organizational capabilities required to deliver on this next development phase and we expect to accelerate those efforts as we progress through the year. Our two rare disease assets, dasyclogon in congenital hyperinsulinism and Gepakrutide for short bowel syndrome, are an active review by the FDA with the DUFA dates in Q4. In parallel with the regulatory process, we are engaging in partnership discussions for future commercialization. We are also advancing our preclinical programs targeting chronic inflammation towards the clinic and expect to initiate first in human trials with our K1.3 iron channel blocker this year. We intend to provide an update on the potential next steps with the complement C3 inhibitor in due course. Moving to slide five, I will now turn over the call to our chief medical officer, David Kendall, to discuss our R&E pipeline. David.

Thank you very much, Adam. Today, I would like to focus my remarks on the continued advancement of our obesity program and also provide an update on the regulatory progress with our two rare disease assets. Turning to slide six, I will begin with petrolentide, our long-acting amylin analog. Amylin agonism provides a unique and distinct mechanism for achieving weight loss in people with overweight and obesity, and represents an exciting potential alternative to incretin-based treatments. Amylin agonism reduces body weight by enhancing satiety and restoring leptin sensitivity, in contrast to the reductions in appetite and prospective food intake that are observed with GLP-1-based therapies. Furthermore, non-clinical data have demonstrated that amylin agonists, including petrolentide, 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 observations 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. We have previously presented data demonstrating a mean weight loss of more than 5% in healthy, lean, and overweight and obese individuals after weekly doses of both 0.6 and 1.2 milligrams administered for six weeks, with these data presented in full at Obesity Week 2023. We remain both optimistic and excited about the potential for our amylin analog and are very encouraged by the significant weight loss observed, which is similar to results reported in initial short-term studies of GLP-1-based therapies. Importantly, we also believe that the tolerability profile of petrolatide offers the opportunity for a considerable improvement compared reported in clinical trials, and experienced in real-world settings with incretin-based treatments. We are on track and expect to report top-line data from the 16-week trial of petrolentide late this quarter. In this Phase 1b trial, we are exploring significantly higher doses of petrolentide using a dose titration scheme. and we anticipate this trial will inform both doses and dose titration schemes planned for a comprehensive Phase IIb trial, which is expected to initiate in the second half of 2024. In line with Adam's initial remarks, GLP-1-like weight loss after 16 weeks would reinforce our conviction that petrolentide has the potential to be an effective monotherapy We truly believe that with petrolentide, we have a unique opportunity to establish a new class of therapies for the treatment of overweight and obesity. Turning to slide seven and turning our attention to dapiglutide, our first-in-class and only-in-class dual GLP-1, GLP-2 receptor agonist. Dapiglutide is designed as a potent GLP-1 agonist targeting significant weight reduction and offers the potential to also leverage GLP-2 pharmacology and improve gut barrier function, as well as addressing the low-grade inflammation associated with metabolic disease, representing a truly differentiated incretin asset. In obesity, low-grade inflammation is thought to further drive many common comorbidities, and we believe that dual GLP-1, GLP-2 receptor agonism can play an important potential role not only targeting weight loss, but also directly affecting a number of key obesity-related comorbid conditions, including liver disease, cardiovascular disease, and neurodegenerative disease, including Alzheimer's. We anticipate reporting top-line data from the investigator-led Phase IIa DREAM trial in the coming weeks. DREAM was specifically designed to provide an initial assessment of the potential of dapiglutide to both reduce body weight and target low-grade inflammation, as well as address the well-described abnormalities in gut barrier function. The initial top-line data will focus on weight loss as well as safety and tolerability, and we look forward to further detailed results assessing inflammatory markers and gut biopsy findings, which will be presented at future scientific meetings. Speaking to the weight loss potential of dapiglutide, it is important to highlight that the DREAM trial is exploring dose strengths of DAPI up to 6.0 milligrams, which were also assessed in the previously reported multiple descending dose trial, where a mean relative reduction in body weight of 4.3% was observed after weekly doses over four weeks. In the ongoing Phase 1b trial, we are exploring significantly higher doses of dapaglutide over 13 weeks of treatment using a dose titration scheme and expect top-line data in the second half of 2024. These data will be used to more fully inform plans for the larger Phase 2b trial, which is expected to begin in the first half of 2025. Turning now to slide eight in the servodutide program, the glucagon GLP-1 receptor dual agonist being developed by Beringer Ingelheim. Beringer reported the exciting and impressive top line data from the phase two trial with servodutide in people with metabolic dysfunction associated steatohepatitis, or MASH, in February. These data demonstrated that 83% of participants treated with servodutide showed an improvement in biopsy measures of MASH without worsening of fibrosis, stages F1, F2, and F3, after 48 weeks when compared to placebo. Importantly, servodutide also met all secondary endpoints, including a statistically significant improvement in liver fibrosis. This is the first report demonstrating an improvement in fibrosis with a GLP-1-based therapy, providing evidence for differentiation among GLP-1-containing weight loss medications. We look very much forward to seeing these data presented in full at the upcoming European Association for the Study of the Liver Congress in Milan on June 7. Based on the positive results from the 46-week phase 2 trial in people with obesity and overweight presented last year at both the American Diabetes Association and the European Association for the Study of Diabetes, as well as the positive results from the previous 16-week phase 2 trial in type 2 diabetes patients, servodutide is now in phase 3 for the treatment of obesity and overweight, with recruitment into the trials progressing very well. Behringer have also communicated that they anticipate moving forward with Phase III studies in MASH as quickly as possible. Now turning to Slide 9 for an update on the regulatory status of our program for dosiglucagon in congenital hyperinsulinism. Following the complete response letter issued by the US FDA in December of last year identifying deficiencies at a third-party manufacturing facility that were not specific to dosiglucagon, have now resubmitted part one of our NDA, so-called original one, which targets dosing of daziglucagon up to three weeks duration. This NDA has now been accepted by the US FDA with the PDUFA goal date October 8, 2024. This represents a significant opportunity for Zealand to address a major unmet medical need for these children and their families. If approved, we plan to make daziglucagon available to U.S. healthcare professionals and patients as soon as possible and continue to actively engage with potential partners for future commercialization. We also expect to submit the additional analyses requested by the FDA from existing continuous glucose monitoring datasets in support of part two of the NDA for dosing beyond three weeks in the second half of 2024. We anticipate that longer-term therapy will be necessary for the vast majority of children living with congenital hyperinsulinism. Turning to slide 10 in clopaglitide, our long-acting GLP-2 analog that we believe has the potential to be the best in-class therapy for the treatment of adult patients with short bowel syndrome and intestinal failure who are dependent on parenteral support. As we have previously shared, the NDA for glipaglutide was submitted in December 2023 and is now under active review at the FDA with the PDUFA goal date of December 22nd, 2024. As with our CHI program, we are actively engaged in partnering discussions for glipaglutide. And with that, I would like to now turn the call over to our Chief Financial Officer, Henrietta Venicky, to review financial results for the first quarter of 2024. Henrietta?