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Zealand Pharma A/S
8/11/2022
Good day and thank you for standing by. Welcome to the Zillian Farmer's second quarter 2022 financial results 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. And to ask a question during the session, you will need to slowly press star 1 and then 1 on your telephone. You will then hear an automated message advising that your hand is raised. Please note that today's conference is being recorded. I would now like to hand over to your speaker, Anna Krasowska. Please go ahead.
Thank you, operator. Welcome and thank you for joining us today to discuss VLIN's second quarter results for 2022. I'm Anna Krasowska, Vice President of Investor Relations and Corporate Communications at VLIN. With me today are the following members of VLIN's management team. Adam Stainsbeth, President and Chief Executive Officer, Matt Dallas, Senior Vice President and Chief Financial Officer, and David Kendall, Chief Medical Officer. You can find the related company announcement and supporting information on our website at zeelandpharma.com. I would like to point out that we will be making forward-looking statements that are subject to risks and uncertainties. These statements are valid only as of today, and the company assumes no obligation to update them except as required by law. Please refer to recent filings for a more complete picture of risks and other factors. With that, I will turn the call over to President and CEO Adam Sainstra. Adam?
Thank you, Anna, and thanks to everyone for joining today. Please turn to slide three. This has been a busy quarter for the company, and I'm really happy with the progress we have made on multiple fronts following the announcement of our strategy to prioritize investments into R&D. In light of these changes, I'm pleased that we completed the sales of Vigo to Mankind in May. For the Sigalock Rescue Pen, we are in advanced partner discussions, and I hope to provide an update on this front soon. In the second quarter, we strengthened our balance sheet. First, by amending the existing node purchase agreement with Oberland Capital, and secondly, by executing a private placement with certain institutional investors. This has extended our cash runway beyond important clinical milestones. As part of the restructuring activities, we continue to focus on improving our operational effectiveness and implementing corporate cost reductions. Earlier this week, we announced the decision to end the non-liquid ADS program, which has been in place since August 17. Today, the American depository shares accounts for less than 1.5% of the total share capital. And by consolidating our listing to Nasdaq Copenhagen, we believe we can maintain trading flexibility for global investors while achieving certain operating efficiencies for the company and reducing costs. Following those corporate updates, I would like to touch on the clinical pipeline to briefly review some of the progress and upcoming milestones before I turn the call over to David Kendall for additional details and color. Key priorities are shown on slide four. As we review the pipeline, I want to draw your attention to the revised timelines related to static lupine bi-hormonal artificial pancreas system. This is a consequence of focusing our resources as we execute our new strategy. and not a reflection of our for the program. In May, we announced positive results from the phase three trial of DASIGluogon in infants with congenital hyperinsulinism, or CHI. We are preparing a new drug application, or NDA, for DASIGluogon, and following our pre-NDA meeting with the FDA, we now anticipate submission in the first quarter of 23. At the scientific sessions of the American Diabetes Association in June, we presented Phase 1 data for dabiglutide, our long-acting DLD1-DLD2 dual agonist, showing encouraging weight loss in healthy volunteers. This data has given us the confidence to move this molecule forward in obesity, as also announced in June. In July, we achieved last patient last visit in EaseSBS1. our phase three trial with glipaglutide in short viral syndrome, and now look forward to seeing the results late in the quarter. At the upcoming European Association for the Study of Diabetes annual meeting in September, our partner, Boerner Ingelheim, will present phase two data for the gluagon GLT1 receptor dual agonist in patients with type two diabetes. And finally, we anticipate initial phase one clinical data from our Ameline analog later in the year. And with that, I will now turn over the call to David Kendall. David was appointed C-Lens chief medical officer in June, and for the past two years, he has been serving as a senior global medical advisor to the company. And before joining us, he has held senior leadership positions in clinical and academic medicine and in the biopharmaceutical industry. We're extremely excited to harness his broad experience in diabetes and metabolic diseases that spans more than 35 years. David.
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