Viking Therapeutics Reports First Quarter 2022 Financial Results and Provides Corporate Update

SAN DIEGO, April 27, 2022

• Completion of Enrollment in Phase 2b VOYAGE Study of VK2809 in Biopsy-Confirmed NASH Expected in 2H22   
• Phase 1 Study of Dual GLP-1/GIP Agonist VK2735 Ongoing; Results Expected by Year-End 
• Quarter-End Cash Balance of $185M Provides Runway Through Multiple Clinical Catalysts

SAN DIEGO, April 27, 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 first quarter ended March 31, 2022, and provided an update on its clinical pipeline and other corporate developments.

Highlights from the Quarter Ended March 31, 2022, and Other Recent Events:

"The first quarter of 2022 was a period of continued momentum at Viking, as we expanded our clinical portfolio and advanced our existing programs," stated Brian Lian, Ph.D., chief executive officer of Viking. "Early in the quarter, we announced the initiation of clinical development with our newest pipeline program, VK2735, a novel dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors, for the treatment of various metabolic disorders.  We expect to report the initial results from a Phase 1 trial of this compound later in the year.  During the quarter, we also continued enrollment in the ongoing Phase 2b study of our lead program VK2809 in patients with biopsy-confirmed NASH and fibrosis.  We expect to complete enrollment in this study in the second half of 2022.  With our rare disease program, VK0214, for X-linked adrenoleukodystrophy, during the first quarter we initiated activities to satisfy the FDA's request for an additional pre-clinical study.  We expect to submit the requested data to the Agency in the second quarter of this year and look forward to resuming clinical development of this important program.  We are advancing each of these programs while maintaining continued financial discipline.  We believe our quarter-end cash balance of $185 million provides a runway extending through important data readouts from each of our clinical programs."

Pipeline and Corporate Highlights

• Phase 2b VOYAGE study evaluating VK2809 for the treatment of NASH continues enrolling patients. 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 best-in-class therapeutic potential in a range of lipid disorders, including non-alcoholic steatohepatitis (NASH).
  
  The company previously announced positive results from a 12-week Phase 2a trial of VK2809 in patients with hypercholesterolemia and non-alcoholic fatty liver disease, which achieved both its primary and secondary endpoints, demonstrating potent reductions in liver fat content and plasma lipids.  Key results from the Phase 2a trial included data showing that 88% of patients receiving VK2809 experienced at least a 30% reduction in liver fat content at 12 weeks, including all patients receiving the trial's lowest dose of 5 mg daily.  In addition, patients receiving VK2809 experienced improvements in low-density lipoprotein cholesterol (LDL-C), triglycerides and atherogenic proteins.  These findings are of particular interest as the compound's lipid-lowering effects may lead to improved cardiovascular benefits, a significant advantage when compared to other drugs and mechanisms that have been shown to increase plasma lipids and potentially cardiovascular risk.  Patients treated with VK2809 in this study also experienced durable reductions in liver fat, with the majority remaining responders four weeks after completion of dosing.  This study also demonstrated the promising safety and tolerability profile of VK2809.  In contrast with other clinical programs in this area, patients treated with VK2809 reported lower rates of GI disturbances such as diarrhea or nausea compared with patients receiving placebo.  In addition, no serious adverse events were reported among patients receiving VK2809 or placebo.
  
  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 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 patients 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 first quarter, screening and enrollment continued at both U.S. and ex-U.S. study sites, and the company expects to complete enrollment in the second half of 2022.

• Preclinical study supporting Phase 1b VK0214 trial ongoing; On track to submit data to FDA in 2Q22. 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, Viking 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.  Treatment with VK0214 demonstrated dose-dependent exposures, no evidence of accumulation, and a half-life consistent with anticipated once-daily oral dosing.  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.
  
  Based on these findings the company initiated a Phase 1b study of VK0214 in patients with the adrenomyeloneuropathy (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 primary objectives of the study are to evaluate the safety and tolerability of VK0214 administered once-daily over a 28-day dosing period.  The study also includes an exploratory assessment of the impact of VK0214 on plasma levels of very long chain fatty acids, as well as an evaluation of the pharmacokinetics of VK0214 in these patients.
  
  In January 2022, the company was informed that this trial had been placed on clinical hold by the U.S. Food and Drug Administration (FDA or Agency).  The Agency requested that the company complete an additional preclinical study prior to continuation.  This request was not due to 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.  As a Phase 2 trial, regulatory guidance requires that a rodent genotoxicity study be completed prior to initiation.
  
  The company expects to complete the requested study and submit the results to the FDA later this quarter, with a goal of resuming dosing in the study as soon as possible thereafter.

• Phase 1 trial of dual GLP-1/GIP agonist VK2735 ongoing. In the first quarter, the company announced initiation of clinical development with VK2735 – an internally-developed compound targeting dual activation of the glucagon like peptide-1 (GLP-1) and the glucose dependent insulinotropic peptide (GIP) receptors. The company is advancing VK2735 for the potential treatment of a range of metabolic disorders.
  
  In November 2021, at the annual meeting of The Obesity Society, the company presented the first data from this program, highlighting improvements in metabolic profile among diet-induced obese (DIO) mice treated with the company's compounds as compared to control cohorts.  Specifically, weight loss, glucose control, and insulin sensitivity were enhanced following treatment with the company's dual agonists compared to the effects observed following treatment with the GLP-1 mono-agonist semaglutide, when administered at the same dose for the same time period.  Reductions in liver fat content were generally larger among animals treated with Viking's compounds relative to liver fat reductions observed among animals treated with semaglutide.  These results suggest that the addition of GIP receptor activity improves upon the effects achieved with activation of the GLP-1 receptor alone.   
  
  In the first quarter, the company announced the initiation of a Phase 1 clinical trial evaluating VK2735 in healthy volunteers.  The Phase 1 trial is a randomized, double-blind, placebo-controlled, SAD/MAD study in healthy adults. The primary objectives of the study include an evaluation of the safety and tolerability of single and multiple doses of VK2735 delivered subcutaneously, as well as the identification of doses suitable for further clinical development.  The study will also evaluate the pharmacokinetics of VK2735 following single and multiple doses. Exploratory pharmacodynamic assessments include evaluations of changes in body weight and liver fat content after four weeks of once-weekly administration.  Results from this study are expected to be available in the second half of the year.

• Strong balance sheet continues to support advancement of clinical programs into late stage development. Viking ended the first quarter of 2022 with $185 million in cash, cash equivalents and short-term investments.
  
  
• Upcoming investor events. Viking management will participate virtually in the following upcoming investor event:

H.C. Wainwright Annual Global Life Sciences Conference
Dates: May 23 - 25, 2022