Zealand Pharma A/S

Thank you, operator. Welcome, and thank you for joining us today to discuss Zeeland's interim results for the first six months of 2023. With me today are the following members of Zeeland's management team. Adam Steenke, President and Chief Executive Officer, Henrietta Benke, 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, we will be making forward-looking statements that are subject to risks and uncertainties. With that, I will turn the call over to Adam Stainsberg, President and CEO. Adam?

Thank you, Anna, and thanks to everyone for joining today. I will begin on slide three. I'm very proud of what CELAN has achieved in the first six months of 2023. With a strong focus on R&D, We have successfully progressed our product candidates within obesity, rare diseases, and type 1 diabetes. Also, we have significantly strengthened our balance sheet to ensure a cash runway until mid-26. Of course, the big news of today is Bernhard Engelheim's announcement that they are advancing Cevutotide, co-invented with Zealand Pharma, into three global phase 3 clinical trials in people living with overweight and obesity. We are very encouraged by the phase two results presented at this year's ADA conference in June, and certainly share Boehringer's excitement about the potential for Sivertotype and the phase three trials expected to start in the second half of the year. Also in our obesity portfolio, we presented results from the phase one single ascending dose trial at ADA in June, demonstrating profound reduction in body weight after only one week of dosing of our long-acting amylin analog. Then in July, we announced top-line results from part one of the phase one multiple ascending dose trial demonstrating improved weight loss after six weeks of once-weekly treatment with lower doses of CP8396. Based on the significant weight reductions and mild adverse event profile, we have started part two of the multiple ascending dose trial, assessing both longer duration of treatment and higher doses of CP8396. And we look very much forward to seeing those data and announcing them in the first half of 2024. With dasycluvagone, we are excited about the regulatory submissions to the US FDA for the treatment of congenital hyperinsulinism and the regulatory submission to the European Medicines Agency for the treatment of severe hypoglycemia. Moving to slide four, we are well on track to deliver on the strategic objectives that we have had outlined for 2023. In the second half of the year, we expect to submit the new drug application for the US FDA for clopacritide for the treatment of short bowel syndrome. Also in the second half, We expect to initiate the 13-week dose titration trial with dabiglutide, our dual GLP-1, GLP-2 receptor agonist, and complete preclinical activities with CP6590, our GIP analog. The dialogues with potential partners for our rare disease programs are progressing according to plan, and we aim to enter into a partnership agreement for Dasikluogon in congenital hyperinsulinism in the second half of this year. Moving to slide five, I will now turn over the call to our CMO, David Kendall, to present our R&D pipeline and the recent results from our BCT portfolio. David.

Thank you, Adam. Today, I will focus my remarks on the most recent results from two of our product candidates targeting obesity, namely the Phase 2 results with the dual glucagon GLP-1 receptor agonist, Cervodutide, presented at the American Diabetes Association Scientific Sessions in June, and the top-line results from Part 1 of the Phase 1B Multiple Ascending Dose Trial with our long-acting amylin analog, ZP8396, announced in July. Turning to slide six, most people living with overweight and obesity who are candidates for pharmacologic therapy will benefit from weight loss of between 15% and 25%. While there are several promising pipeline candidates from a number of companies targeting weight loss in this range, there remains a significant treatment gap and unmet medical need to target the complications of obesity and improve tolerability of treatment. Bringing differentiated anti-obesity treatments to the market that address the different needs of obesity subpopulations and improve tolerability will be critically important. Please turn your attention to slide seven. Obesity is a complex disease that is amenable to pharmacologic treatments that target a number of unique metabolic pathways. We anticipate that the future treatment landscape in obesity will contain several categories of molecules Today, this is dominated by molecules with a GLP-1 receptor backbone, including dual and triple agonists that target several important metabolic pathways. We are incredibly excited about the potential for our amylin agonist in the management of overweight and obesity and firmly believe that amylin agonism holds significant potential for offering substantial weight loss and the potential for a better tolerability profile when compared with the GLP-1-based therapies. Amilin is a validated non-incretin mechanism and has been shown to be very effective both as monotherapy and in combination with GLP-1-based treatments. We also believe that the success of future anti-obesity treatments will be determined by their effects on both body weight and important features of differentiation, including targeting comorbidities, improving tolerability, and offering alternatives to these incretin-based mechanisms. On slide eight, we outline our portfolio of novel and differentiated assets for the potential treatment of overweight and obesity, highlighting the mechanistic rationale behind each molecule. Our therapeutic approach aims to, one, achieve increased weight loss, and two, provide additional effects to address specific comorbidities, and three, improve tolerability. Each molecule is differentiated through peptide target, design, or formulation. Turning to slide 9 and recent clinical data, positive results from the Beringer-Ingelheim-sponsored Phase II dose-finding trial with servodutide, the glucagon GLP-1 receptor dual agonist targeting energy intake and energy expenditure, were presented at the American Diabetes Association Scientific Sessions in San Diego in June of this year. This study in individuals with overweight or obesity demonstrated significant and dose-dependent reductions in body weight of up to 19% after 46 weeks of treatment. Up to 40% of participants receiving servodutide achieved body weight reductions of more than 20% at the end of study. As illustrated by the figures, body weight reductions had not yet plateaued at week 46, indicating that further reductions are likely to be observed with longer treatment duration. Please now turn to slide 10. In July, we announced additional positive topline results from Part 1 of the Phase 1b Multiple Ascending Dose Trial with our long-acting amylin analog, ZP8396. demonstrating mean weight loss of more than 5% in healthy, lean, and overweight people with multiple doses of ZP8396 at both 0.6 and 1.2 milligrams administered once weekly over six weeks. These data compared to the mean weight loss of 2.6, 3.6, and 4.2% observed following single-dose administration of 0.7, 1.4, and 2.4 milligrams of ZP8396 administered in the single ascending dose trial reported earlier this year. In the most recent Phase 1b study, ZP8396 was judged to be well tolerated with no serious or severe adverse events and no withdrawals from the study. Gastrointestinal side effects were the most common adverse event reported, all were mild and most occurred within two days of the initial dose. We are very encouraged and believe that the weight loss observed are on par with the results reported in initial studies of incretin and GLP-1-based therapies. In addition, we believe that the tolerability of ZP8396 offers the possibility of a considerable improvement over the adverse event profiles reported with these incretin-based therapies. We have recently initiated Part 2 of the Multiple Ascending Dose Trial, which is a 16-week study exploring significantly higher doses of ZP8396 utilizing a dose titration scheme, and these study results are expected in mid-2024. With these data, our confidence in the potential of our long-acting amylin analog to achieve substantial weight reduction in people living with overweight and obesity has significantly increased. And we believe that ZP8396 can play an important role as monotherapy to achieve and maintain weight loss and thus provide an alternative to GLP-1-based therapies. In addition, ZP8396 may play an important role in combination with incretin-based therapies in those individuals who will benefit from additional weight loss and help in maintaining that weight loss. Now turning to slide 11. My final remarks today are related to our congenital hyperinsulinism program and the new drug application for doziglucagon, which we are pleased to have submitted to the US FDA in June of this year. We believe that doziglucagon, if approved, can be an important and effective treatment option for this rare and devastating disease. This program represents a significant opportunity for Zeeland to address a major unmet medical need for these children and their families As Adam has mentioned, discussions with potential partners are progressing as planned, and we aim to enter into a partnership agreement for dasi glucagon in congenital hyperinsulinism in the second half of this year. With that, I would now like to turn the call over to our Chief Financial Officer, Henrietta Venike, to review our financial results for the first six months of 2023. Henrietta?