Viking Therapeutics, Inc.

successfully achieved both its primary and secondary endpoints. Patients receiving VK2809 at doses as low as 5 milligrams daily demonstrated highly statistically significant reductions in liver fat content, as well as improvements in LDL cholesterol. VK2809 also performed well on secondary measures in this study, demonstrating significant reductions in other plasma lipids, such as triglycerides, apolipoprotein B, and lipoprotein A. Follow-up data presented at the 2020 EASL conference showed that treatment with VK2809 resulted in durable reductions in liver fat with the majority of patients remaining responders four weeks after completion of the study. Importantly, no serious adverse events were reported in this trial among patients receiving VK2809 or placebo. We believe that VK2809's exceptional low dose potency in reducing liver fat and plasma lipids, its durable effect, and its safety and tolerability profile to date establish it as a best-in-class compound for the potential treatment of patients with NASH and fibrosis. Notably, VK2809's lipid lowering effects may lead to improved cardiovascular benefits in treated patients. This is a critical advantage in a field where multiple competitive mechanisms in development are associated with elevations in lipids that are known to increase cardiovascular risk. Following the promising results observed in our 12-week Phase 2A study, we initiated the Phase 2B study to evaluate VK2809 in patients with NASH. This trial, called VOYAGE, is a randomized, double-blind, placebo-controlled, multi-center trial designed to assess the efficacy, safety, and tolerability of VK2809 in patients with biopsy-confirmed NASH and fibrosis. The study is enrolling patients across five treatment arms, and the target population includes patients with F2 and F3 fibrosis, as well as up to 25% with F1 fibrosis. The primary endpoint of the study will evaluate the change in liver fat content as assessed by magnetic resonance imaging proton density fat fraction from baseline to week 12 in patients treated with VK2809 as compared to patients receiving placebo. Secondary objectives include the evaluation of histologic changes assessed by hepatic biopsy after 52 weeks of treatment. Through the third quarter, enrollment and dosing in voyage continued at sites in the U.S. and abroad. We continue to navigate a challenging clinical environment, and we expect to complete enrollment and announce top-line data in 2022. I'll now provide an update on our VK0214 program, which is our second orally available small molecule thyroid hormone receptor beta agonists. BK0214 is currently in development for the treatment of X-linked adrenoleukodystrophy, or XALD. XALD is a rare and often fatal metabolic disorder characterized by a breakdown in the protective barriers surrounding brain and nerve cells. The disease, for which there is no FDA-approved therapeutic, is caused by mutations in a gene known as ABCD1, which encodes a peroxisomal transporter of very long-chain fatty acids. As a result of these mutations, transporter function is impaired and patients are unable to efficiently metabolize very long chain fatty acids. The resulting accumulation of these compounds is believed to contribute to the onset and progression of clinical signs and symptoms in patients with XALD. What makes VKO214 a promising potential therapeutic in this setting stems from the key regulatory role played by the thyroid hormone beta receptor on the expression of an alternative very long chain fatty acid transporter known as ABCD2. Various preclinical models have demonstrated that increased expression of ABCD2 can lead to improved and potentially normalized very long chain fatty acid metabolism. For this reason, we believe that VK0214's potent activation of the thyroid hormone beta receptor may represent a potential therapeutic approach to the treatment of XALD. Last year, we initiated a randomized, double-blind, placebo-controlled, single ascending and multiple ascending dose phase one study of VK0214 in healthy volunteers. The objectives of the study were to evaluate the safety, tolerability, and pharmacokinetics of VK0214 administered orally once daily for up to 14 days. This study successfully achieved its primary objective with VK0214 shown to be safe and well tolerated at all doses evaluated. No serious adverse events were reported and no treatment or dose-related trends were observed for gastrointestinal side effects, vital signs, or cardiovascular measures. Treatment with VKO214 demonstrated dose-dependent exposures, no evidence of accumulation, and a half-life consistent with anticipated once-daily oral dosing. A secondary objective of the study was to evaluate laboratory assessments, including a lipid panel, to determine potential pharmacodynamic effects following exposure to VK0214. The results showed that subjects who received VK0214 experienced reductions in LDL cholesterol, triglycerides, apolipoprotein B, and lipoprotein A following 14 days of treatment. Many of the observed lipid reductions achieved statistical significance, though the study was not powered to demonstrate statistical significance on laboratory assessments. Given these positive results, Earlier this year, we initiated the Phase 1b study of VK0214 in patients with the adrenomyeloneuropathy, or AMN, form of XALD. AMN is the most common form of XALD, affecting approximately 50% of those with the disease. Clinical manifestations include progressive leg weakness, incontinence, and sexual dysfunction. Our Phase 1b study is a multicenter, randomized, double-blind, placebo-controlled trial in adult male patients with AMN. The study is initially targeting enrollment across three cohorts, placebo, VKO214 dosed at 20 milligrams daily, and VKO214 dosed at 40 milligrams daily. Depending on a blinded review of preliminary safety, tolerability, and pharmacokinetic data, additional dosing cohorts may be pursued. The primary objectives of the study are to evaluate the safety and tolerability of VKO214 administered once daily over a 28-day dosing period. In addition, the study will assess the efficacy of VKO214 at lowering plasma levels of very long-chain fatty acids and evaluate the pharmacokinetics of VKO214 in this population. Enrollment in this study is ongoing, and we currently expect top-line results to be available in 2022. In addition to our ongoing clinical trials targeting NASH with VK2809 and XALD with VK0214, we have been working hard to expand our pipeline of novel, best-in-class therapeutics targeting areas of unmet need in metabolic and endocrine disorders. To this end, earlier this week, we reported the first data from an internally developed program targeting novel dual agonists of the glucagon-like peptide 1, or GLP-1, and the glucose-dependent insulinotropic peptide or GIP receptors. Agonists of the GLP-1 receptor have demonstrated consistent benefits in diseases such as type 2 diabetes by improving insulin sensitivity, reducing plasma glucose, and reducing overall body weight. As a result of these therapeutic effects, multiple GLP-1 receptor agonists have been approved for both diabetes and obesity. More recently, the focus in this area has turned to the development of therapies that can maintain post-activation of the GLP-1 receptor while also activating other important receptors related to metabolic control. One of these approaches has been to simultaneously target the GIP receptor to provide enhanced stimulation of insulin secretion, thereby improving overall glucose control. The GIP receptor is known to regulate insulin secretion and to provide modest activation of the glucagon receptor. A single molecule with combined activity at both the GLP-1 and GIP receptors may therefore provide improved metabolic benefit relative to activation of either single receptor alone. Indeed, recent clinical data have demonstrated that dual GLP-1-GIP agonists not only provide excellent glucose control, but also potent reductions in body weight. In 2019, we initiated an exploratory program targeting novel dual agonists of the GLP-1 and GIP receptors. This program has evolved nicely, and we have been pleased with our progress and portfolio to date. We are excited to now be in the position to share some of the early data generated by this program. Earlier this week, we presented two posters at Obesity Week, the annual meeting of the Obesity Society, highlighting certain preclinical studies conducted in an in vivo model of obesity. The results of these studies demonstrate that in this model, the addition of GIP receptor activity improves upon the observed effects resulting from activation of the GLP-1 receptor alone. Weight loss, glucose, and insulin effects were enhanced in the Viking series of dual agonists compared with the effects observed with the GLP-1 agonist comparator, semaglutide, when administered at the same dose for the same length of time. In separate studies, the effect sizes observed with the Viking series of dual agonists were similar to those observed following treatment with Terzepatide, a dual GLP-1 GIP receptor agonist currently in clinical development. Reductions in liver fat content were generally numerically larger among animals treated with the Viking compounds relative to the liver fat reductions observed among trizepatite-treated animals. Highlights from the poster presentations include results showing that treatment with our novel dual agonists for 21 days resulted in statistically significant mean reductions in body weight of up to 27% relative to vehicle treatment. In addition, treatment with our dual agonists resulted in statistically significant mean reductions in blood glucose of up to 23% and plasma insulin reductions of up to 57% relative to vehicle treatment. In a separate 14-day study, treatment with our novel dual agonists resulted in statistically significant mean reductions in plasma triglycerides of up to 37% relative to vehicle. In this study, treatment with our compounds also resulted in statistically significant mean reductions in liver triglycerides of up to 49% relative to vehicle treatment. In general, Data from these studies demonstrated statistically significant improvements on these measures compared with the control cohort that received treatment with semaglutide. Results were also comparable to those observed among the control cohort of animals treated with the development stage dual agonist triseptide. We are highly encouraged by these early results and look forward to presenting additional data from this program at future scientific meetings. Based on the results from these and other preclinical studies, We plan to initiate clinical studies with a lead compound from this program in the coming months. We are excited to be advancing this new program, and we will provide additional information on the trial design and other details at the appropriate time. As we advance our clinical programs and expand our therapeutic pipeline, we're also keenly focused on the prudent management of our balance sheet. As Greg noted earlier, we ended the third quarter with approximately $216 million in cash. We believe this provides us with the resources to complete our ongoing clinical studies and advance our programs well into later stage development. In conclusion, we remain focused on the development of first in class and or best in class therapeutics for the treatment of metabolic and endocrine disorders. We believe our clinical track record establishes the company as a leader in the field and we continue to advance our existing clinical programs as well as explore new opportunities to create value for patients, clinicians, and investors. Our lead program evaluating VK2809 for the treatment of NASH and fibrosis is progressing through the Phase 2B Voyage Study, and we expect to complete enrollment and report initial data from this study in 2022. Our second clinical candidate, VK0214, for the treatment of XALD, is in an ongoing Phase 1B study in patients with adrenomyeloneuropathy and we expect to complete this study in 2022. Finally, as a result of our internal efforts to expand our pipeline, earlier this week we announced the initial results from a series of novel dual agonists of the GLP-1 and GIP receptors, which have shown promise in preclinical models. We expect to initiate clinical development of a lead compound from this series in the coming months. This concludes our prepared comments for today. Thanks again for joining us, and we'll now open the call for questions. Operator?

Yes, thank you. At this time, we will begin the question and answer session. To ask a question, you may press star, then 1 on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star, then 2. At this time, we will pause momentarily to assemble the roster. And today's first question comes from June Lee with Truist Securities.

Hi, thanks for the update and for taking our questions. The first question is, are you able to disclose where you are in the enrollment of Voyage? And can we expect the data in the first half or second half of 22? And I have a follow-up.