2/9/2022

speaker
Operator

Welcome to the Viking Therapeutics 2021 Fourth Quarter and Year-End Financial Results Conference Call. At this time, all participants are in a listen-only mode. Following management's prepared remarks, we will hold a Q&A session. To ask a question at that time, please press the star key followed by 1 on your touch-tone phone. If anyone has difficulty hearing the conference, please press star 0 for operator assistance. As a reminder, this conference call is being recorded today, February 9th, 2022. I would now like to turn the conference over to Vikings Manager of Investor Relations, Stephanie Diaz. Please go ahead, Stephanie.

speaker
Stephanie Diaz
Manager of Investor Relations

Hello, and thank you all for participating in today's call. Joining me today is Brian Lanz, Vikings President and CEO, and Greg Zante, Vikings CFO. Before we begin, I'd like to caution that comments made during this conference call Today, February 9, 2022, will contain forward-looking statements under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Vikings' expectations regarding its development activities, timelines, and milestones. Forward-looking statements are subject to risk and uncertainties that could cause actual results to differ materially and adversely, and reported results should not be considered as an indication of future performance. These forward-looking statements speak only as of today's date, and the company undertakes no obligation to revise or update any statement made today. I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters. I'll now turn the call over to Brian Leon for his initial comments.

speaker
Brian Lanz
President and CEO

Thanks, Stephanie, and thanks to everyone dialed in by phone or listening on the webcast. Today, we'll review our fourth quarter and full year 2021 financial results. and provide an update on recent developments and progress with our pipeline programs and operations. 2021 was a very productive year for Viking. During the year, we continued to make progress with our lead program, VK2809, currently in a Phase IIb study for patients with biopsy-confirmed NASH and fibrosis, opening additional clinical trial sites and continuing enrollment of new patients. We expect to complete enrollment of this trial and report top-line data by year end. In 2021, we also reported data from the first in-human study of VK0214, our second thyroid receptor beta program, demonstrating the compound's impressive safety, tolerability, and preliminary lipid-lowering effects. Following completion of the first in-human study, we initiated a Phase 1b study in patients with X-linked adrenal leukodystrophy, a rare neurodegenerative disease for which there is no cure. We were recently informed that the FDA has placed this study on clinical hold pending completion of an additional preclinical study, and we expect to submit the results of this study in the second quarter. Finally, in recent months, we expanded our clinical pipeline with the addition of a new internally developed program targeting the GLP-1 and GIP receptors for metabolic disorders. We reported two posters from this program at Obesity Week in November, and last month announced the initiation VK2735. I'll have more to say about these programs in a few minutes, but I'd like to highlight as we reflect on the past 12 to 18 months that Viking has transformed over the past several quarters from a company with one clinical program to a company with three active clinical programs across a diverse range of indications with important data inflections for each expected in the next 12 to 18 months. The breadth and depth of our clinical and preclinical pipeline represent an important progression from a single program story into a diversified biopharmaceutical company with programs advancing in multiple important indications. We are proud of the progress we've made and see the last 12 months as providing an important base from which we will advance multiple programs into late-stage development. I'll provide further detail on our operations and development activities after we review our fourth quarter and year-end financial results. I'll turn the call over to Greg Dante, Vikings CFO.

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