Viking Therapeutics Reports Fourth Quarter and Year-End 2021 Financial Results and Provides Corporate Update

Conference call scheduled for 4:30 p.m. ET today

- Data From Three Clinical Programs Expected in the Next 12-18 Months

- Enrollment Continuing in Phase 2b VOYAGE Study Evaluating VK2809 for the Treatment of NASH

- Phase 1 SAD/MAD Trial of Dual GLP-1/GIP Agonist VK2735 Ongoing

- Balance Sheet Remains Strong With Over $200M in Cash to Support Advancement of Clinical Programs

SAN DIEGO, Feb. 9, 2022 /PRNewswire/ -- Viking Therapeutics, Inc. (Viking) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced its financial results for the fourth quarter and year ended December 31, 2021, and provided an update on its clinical pipeline and other corporate developments.

Highlights from the Quarter Ended December 31, 2021, and Other Recent Events:

"The past year was a productive time for Viking as we continued to make progress with our two most advanced clinical programs and further expanded our clinical pipeline with the addition of an important new program," said Brian Lian, Ph.D., chief executive officer of Viking Therapeutics.  "During the fourth quarter, enrollment continued in the Phase 2b VOYAGE trial evaluating our lead program, VK2809, for the treatment of NASH and fibrosis.  We expect to complete enrollment of this trial and report initial data by year-end.  With respect to our Phase 1b trial evaluating VK0214 for the treatment of X-ALD, we were recently informed that this study has been placed on clinical hold by the FDA, pending an additional preclinical study prior to continuation.  This request was not due to any findings from ongoing or previously completed studies, and we expect to submit the information in a timely fashion.  During the fourth quarter of 2021, we also announced an exciting addition to our pipeline, an internally developed dual agonist of the GLP-1 and GIP receptors, for the treatment of metabolic disorders.  Preclinical data from this program were presented at ObesityWeek®, in November, highlighting promising effects on body weight and metabolic profile. We recently announced the initiation of clinical studies of the lead compound from this program, VK2735, and expect to report initial data in the second half of the year.  Throughout these developments we've been fortunate to maintain a strong balance sheet with over $200 million in cash, and anticipate the runway to extend through multiple important data events."

Pipeline and Corporate Highlights

• Enrollment proceeding in Phase 2b VOYAGE study evaluating VK2809 for the treatment of NASH. VK2809 is an orally available small molecule agonist of the thyroid hormone receptor that possesses selectivity for liver tissue, as well as the beta receptor subtype. The compound has demonstrated promising therapeutic potential in a range of lipid disorders, including non-alcoholic steatohepatitis (NASH). A prior 12-week Phase 2a study evaluating VK2809 in patients with non-alcoholic fatty-liver disease and hypercholesterolemia successfully achieved both its primary and secondary endpoints. Patients receiving VK2809 demonstrated statistically significant median reductions in liver fat content ranging from 54% to 60%, as well as improvements in plasma LDL-cholesterol. The effects on liver fat were shown to be durable, with the majority of patients remaining responders four weeks after receiving the last dose in the study. 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). Further, the study demonstrated the encouraging safety and tolerability of VK2809, with no serious adverse events reported and numerically lower rates of gastrointestinal disturbances such as diarrhea reported among treated compared with placebo patients. The company believes that VK2809's potency, tolerability, and safety profile establish it as a best-in-class compound for the potential treatment of patients with NASH and fibrosis. VK2809 is currently being evaluated in a Phase 2b trial in patients with NASH. This trial, called VOYAGE, is a randomized, double-blind, placebo-controlled, multicenter study designed to assess the efficacy, safety and tolerability of VK2809 in patients with biopsy-confirmed NASH and fibrosis. The study is targeting enrollment of patients across five treatment arms: 1.0 mg daily; 2.5 mg daily; 5.0 mg every other day; 10.0 mg every other day; and placebo. The primary endpoint of the study will evaluate the relative change in liver fat content, as assessed by magnetic resonance imaging, proton density fat fraction (MRI-PDFF) from baseline to Week 12 in subjects treated with VK2809, as compared to placebo. Secondary objectives include evaluation of histologic changes assessed by hepatic biopsy after 52 weeks of dosing.During the fourth quarter, screening and enrollment continued at both U.S. and ex-U.S. study sites, and the company expects to complete enrollment and report initial data on the primary endpoint by the end of 2022.
• Phase 1b trial evaluating VK0214 in X-ALD patients on hold pending completion of preclinical study. VK0214 is a novel, orally available thyroid hormone receptor beta agonist being evaluated as a potential treatment for X-linked adrenoleukodystrophy (X-ALD), a rare neurodegenerative disease for which there are currently no pharmacologic treatment options. In June 2021, the company reported the results of a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) Phase 1 study of VK0214 in healthy volunteers. This study successfully achieved its primary and secondary objectives, 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 vital signs, cardiovascular measures, or gastrointestinal side effects such as diarrhea or nausea. Treatment with VK0214 demonstrated dose-dependent exposures, no evidence of accumulation, and a half-life consistent with anticipated once-daily oral dosing. Further, subjects who received VK0214 experienced reductions in LDL-cholesterol (up to 21% from baseline), triglycerides (up to 45% from baseline), apolipoprotein B (up to 28% from baseline) and lipoprotein (a) (up to 42% from baseline) 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 lipid assessments. Following completion of the SAD/MAD Phase 1 study, the company initiated a Phase 1b study of VK0214 in patients with the adrenomyeloneuropathy, or AMN, form of X-ALD. AMN is the most common form of X-ALD, affecting approximately 50% of those with the disease. The Phase 1b trial is a multi-center, randomized, double-blind, placebo-controlled study in adult male patients with AMN. The study is initially targeting enrollment across three cohorts: 20 mg daily, 40 mg daily, and placebo. The primary objectives of the study are to evaluate the safety and tolerability of VK0214 administered once-daily over a 28-day dosing period. In addition, the study includes an exploratory assessment of changes in plasma levels of very long chain fatty acids, and will evaluate the pharmacokinetics of VK0214 in this population. In January 2022, the company was informed that this trial had been placed on clinical hold by the FDA, pending completion of an additional preclinical study. The request was not due to any findings from ongoing or previously completed studies. Rather, the FDA informed the company that it considers the ongoing trial to be a Phase 2 trial rather than a Phase 1b. As a Phase 2 trial, FDA guidance requires that a rodent genotoxicity study is completed prior to initiation. The company expects to submit the requested data in the second quarter of 2022 with a goal to resume dosing in the study later this year.
• Phase 1 trial of novel dual incretin receptor agonist VK2735 underway. In November 2021, the company announced the results of in vivo studies evaluating a novel series of internally developed dual-acting agonists of the glucagon-like peptide-1, or GLP-1, and the glucose-dependent insulinotropic polypeptide, or GIP, receptors. As summarized below, these studies demonstrated the promising effects of these new compounds on body weight and other metabolic parameters.
• Data from dual incretin receptor agonist program presented at ObesityWeek® 2021. The company's wholly-owned, internally developed series of dual-acting agonists of the GLP-1 and GIP receptors were highlighted in two posters at ObesityWeek 2021, the annual meeting of The Obesity Society held in November 2021. Highlights from the posters include:
• Treatment with Viking dual agonists for 21 days resulted in mean reductions in body weight of up to 27% relative to vehicle (p