Zealand Pharma A/S

Good day and thank you for standing by. Welcome to the Zeeland Pharma results for Q3 2023 conference call and webcast. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, please press star 1 and 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 and 1 again. Please note that today's conference is being recorded. I would now like to have the conference over to your first speaker, Anna Krasovska, Head of Investor Relations. Please go ahead.

Anna Krasovska Thank you, Operator. Welcome, and thank you for joining us to discuss VLIN's interim results for the first nine months of 2023. With me today are the following members of VLIN's management team. Adam Steinsberg, President and Chief Executive Officer, Henrietta Vinica, Chief Financial Officer, and David Kendall, Chief Medical Officer. You can also find the related company announcement and interim report on our website at www.lilandpharma.com. As described on slide 2, we will be making forward-looking statements that are subject to risks and uncertainties. With that, I will turn the call over to Adam Steensban, President and CEO. Adam?

Thank you, Anna, and thanks to everyone for joining today. I'll begin on slide 3. In the third quarter, we saw strong progress across several programs in our pipeline, supported by a solid financial development. Subrutatide advancing into global phase three trials is an important step in Sealand's long-term commitment to bring forward novel therapies for obesity and obesity-related diseases. With the launch of the synchronized trials, Boehringer will be only the third company to initiate a phase three program in this new era of weight loss therapies. We see obesity and related comorbidities as the biggest healthcare challenge of our time. And we believe that CELAN is uniquely positioned to help address this global pandemic, which we'll be discussing further in details at our obesity R&D event in December. In early October, we presented clinical data from multiple ascending dose trials with our long-acting amylin analog at Obesity Week. The data we have seen so far strongly support our confidence in this molecule as a next-generation treatment for overweight and obesity, with potential for weight loss comparable to the GLP-1-based therapies with improved tolerability. For dapaglutide, We have initiated the 13-week dose titration trial to evaluate higher doses than those investigated in the ongoing investigator-led DREAM trial. Dabiglutide is a truly differentiated GLD1-containing molecule, and we are very excited about evaluating its potential to address not only obesity, but also low-grade inflammation associated with metabolic disease. In the third quarter, We have also secured significant regulatory progress on our rare disease assets, including a U.S. FDA priority review and a PDUFA date of December 30th for part one of our NDA for dashing luergon in congenital hyperinsulinism. Henriette will review the financial results in details. Here, I will just mention the revenue recognized in the third quarter for milestones from existing partnerships, which contribute to our solid financial position. Moving to slide four, we are delivering on the strategic objectives that we outlined for the year and remain on track to submit the glipagrutide new drug application for short bowel syndrome to the US FDA this quarter. The C-Land team has also completed non-clinical activities to support potential first in human clinical trials with our GIP analog as well as the KV1.3 ion channel blocker and the complement C3 inhibitor partnered with Alexion. On partnering, we remain engaged in discussions for dasigruvin in CHI, while also preparing for making the product available to patients in the US as soon as possible after a potential approval. While we do believe that FDA's decision to split the NDA into two parts secures the most efficient regulatory review process, this has introduced some complexity in the partnering discussions. And our focus is to secure a partnership that best supports our long-term strategic goals and maximizes value creation. We therefore recognize that a partnership may be pushed into 2024 when we have further clarity on the label and importantly, a PDUFA decision on part one of the NDA. For Gepaglutide in SPS, we expect to engage in more detailed discussions with potential partners once we have submitted the NDA to the FDA. Moving to slide five, I will now turn over the call to our Chief Medical Officer, David Kendall, to discuss our R&D pipeline. David.