Zealand Pharma A/S

Good day and thank you for standing by. Welcome to the Zealand Pharma results for Q3 2024 conference call. At this time all participants are in a listen only mode. After the speaker's presentation there will be a question and answer session. To ask a question during the session you will need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1, 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Anna Kraskowska, Vice President, Investor Relations and Corporate Communications. Please go ahead.

Thank you. Welcome and thank you for joining us today to discuss Zeeland's results for the first nine months of 2024. With me today are the following members of Zeeland's management team. Adam Steinsberg, President and Chief Executive Officer, Henrietta Wittnicker, Chief Financial Officer, David Kendall, Chief Medical Officer, and Eric Cox, Chief Commercial 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 Stainsberg, President and CEO. Adam?

Thank you, Anna, and thanks to everyone for joining today. I'm extremely pleased with the achievements that we have made in the first part of 2024. At Obesity Week on Tuesday, we presented detailed data from the 16-week Phase 1 trial with Petrinatide, our long-acting aminine analog, which we are developing as an alternative to GLB1-based therapies for the management of overweight and obesity. We believe that these results strongly support that Petrinatide is very well tolerated and could provide a better patient experience than incretin-based therapies while providing similar degrees of weight loss. We expect the first participant in the Phase IIb trial with Petrientide to be dosed very soon. And we are also now exploring collaboration opportunities with large pharma companies. With the right partnership, we believe we have an opportunity to not only develop Petrientide as an alternative to GLP-1-based therapies, but also a potential future foundational of first-line therapy for weight management. In that regard, I'm pleased that with us on the call today for the first time is Eric Cox, who recently joined our management team in the role as Chief Commercial Officer. Eric brings 25 years of commercial and business development experience from biotech and leading global biopharma companies. He'll be a very important contributor as we explore co-development and co-commercialization opportunities. for our differentiated obesity programs. We are also very pleased to have reported positive and encouraging top line data from part one of the phase 1B trial with our GP1, GP2 dual agonist dabiglutide. We believe that this candidate holds the potential to be a first in class therapy for obesity and inflammation related comorbidities. The reported data gives us the confidence needed to progress Babiglutide into a comprehensive Phase IIb trial, which is planned to be initiated in the first half of 2025. On the back of the impressive Phase II data with servolutide en masse presented earlier this year, our partner Berner Ingelheim recently announced the initiation of a large global Phase III program for servolutide en masse. Berner also announced that cervidotide has received U.S. FDA breakthrough therapy designation for the treatment of adults with non-cirrhotic mass and moderate or advanced fibrosis. There is a significant overlap between obesity and mass. And with the clinical data reported to date, the ambitious Phase III program, and the recognition by regulators, we believe that cervidotide holds potential as a leading inquisitive therapy for obesity and mass. Turning to slide four, I would like to emphasize the reasons why we are so excited about the potential of betrunentide. We have seen the impact of the first two once-weekly GFP1-based therapies to be approved. In phase three clinical trials of longer duration, they have demonstrated potential for 15 to 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. Real-world data suggests that up to 30% of patients with obesity on a GLP-1 treatment stop within a month before reaching their target dose, and that within one year, only 60% to 70% of patients withdraw from treatment. With Petranitide, we are targeting DLB1-like weight loss of 15% to 20% in longer-term phase 3 trials, with potential for higher quality weight loss and a different and better patient experience. As evident by recent data with Petranitide presented at a BCTV, we are confident that Petranitide has potential for significantly improved GI tallability profile compared to DLB1, receptor agonist, suggesting both lower frequency and milder severity of GI adverse events. And with that, let's move to slide five, as I turn over the call to our Chief Medical Officer, David Kendall, to discuss our R&D pipeline. David?