Viking Therapeutics, Inc. (“Viking”) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, announced its financial results for the third quarter and nine months ended September 30, 2022, and provided an update on its clinical pipeline and other corporate developments.
Highlights from the Quarter Ended September 30, 2022, and Other Recent Events:
“The first three quarters of 2022 have been very productive, and we look forward to announcing the results of three clinical trials in the coming quarters,” stated Brian Lian, Ph.D., chief executive officer of Viking. “With respect to our lead compound, VK2809 for the treatment of NASH and fibrosis, we expect to complete enrollment in our Phase 2b VOYAGE trial by the end of the year, and report data for the primary endpoint of this study in the first half of 2023. During the quarter, the Phase 1 study evaluating our dual incretin receptor agonist candidate, VK2735, continued to enroll and we expect to report the initial data from this study in early 2023. In addition, our Phase 1b trial evaluating VK0214 in X-ALD patients resumed during the quarter and we expect to report data from this trial in the first half of 2023. Finally, we ended the third quarter with $155 million in cash, which provides the runway to advance each of these clinical programs into later stage development.”
Pipeline and Corporate Highlights
- VK2809 Phase 2b VOYAGE Study On Track to Complete Enrollment in Q4 2022; Data Expected in 1H 2023. VK2809 is an orally available, small molecule agonist of the thyroid hormone receptor that is selective for liver tissue as well as the beta isoform of the receptor. The compound has demonstrated encouraging therapeutic potential in liver disorders, producing significant reductions in liver fat and plasma lipids in non-alcoholic fatty liver disease (NAFLD) patients with elevated lipids.
As previously reported, the company’s 12-week Phase 2a trial of VK2809 in patients with hypercholesterolemia and NAFLD successfully achieved both its primary and secondary endpoints, demonstrating significant reductions in liver fat and plasma lipids. Patients treated with VK2809 experienced up to 60% mean relative reductions in liver fat content, and 88% of patients receiving VK2809 experienced at least a 30% reduction in liver fat content. The observed reductions in liver fat were durable, with the majority of patients remaining responders four weeks after completion of dosing. The study also demonstrated a promising safety and tolerability profile for VK2809. No serious adverse events were reported, and the rate of gastrointestinal disturbances such as nausea and diarrhea was lower among VK2809 treated vs. placebo patients. Further, patients treated with VK2809 experienced a reduction in plasma lipids. The elevation of such lipids, including LDL-cholesterol, triglycerides and atherogenic proteins, have been correlated with increased cardiovascular risk. The company believes that the lipid lowering characteristics of VK2809, combined with its safety, significant liver-fat reduction and oral dosing, distinguish it from other drugs in development for this indication and strengthen its position as a best-in-class therapeutic.
Given these findings, Viking initiated the VOYAGE study, a Phase 2b study designed to evaluate VK2809 in patients with non-alcoholic steatohepatitis (NASH) and fibrosis. VOYAGE is a randomized, double-blind, placebo-controlled, multicenter trial designed to assess the efficacy, safety and tolerability of VK2809 in patients with biopsy-confirmed NASH and fibrosis. The target population includes patients with at least 8% liver fat content as measured by magnetic resonance imaging proton density fat fraction, as well as F2 and F3 fibrosis. Up to 25% of patients may have F1 fibrosis provided that they also possess at least one additional risk factor. The primary endpoint of the study will evaluate the change in liver fat content 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.
During the third quarter, enrollment in VOYAGE continued. The company remains on track to complete enrollment by year-end and report data for the primary endpoint in the first half of 2023.
- Phase 1 Study of Dual GLP-1/GIP Agonist VK2735 Continues to Enroll: Data Expected in Early 2023. In early 2022, Viking announced the initiation of a Phase 1 clinical trial of VK2735 for the potential treatment of various metabolic disorders. VK2735 is a dual agonist of the glucagon like peptide-1, or GLP-1 receptor, and the glucose dependent insulinotropic polypeptide, or GIP, receptor.
Initial data from this program, which were presented last November at the annual meeting of The Obesity Society, demonstrated that GIP receptor activity improved upon the metabolic effects achieved through activation of the GLP-1 receptor alone. Importantly, these presentations highlighted significant improvements in weight loss, glucose control and insulin sensitivity among diet-induced obese mice following treatment with the company’s compounds as compared to a GLP-1 mono-agonist, when administered at the same dose for the same period of time. VK2735 treated animals also demonstrated reductions in liver fat content that were generally larger than those observed among animals treated with a GLP-1 mono-agonist.
The ongoing Phase 1 trial is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study. The SAD portion of the study is enrolling healthy adults, while the MAD portion of the study is enrolling healthy adults with a minimum body mass index of 30 kilograms per meter squared. 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 trial 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.
During the third quarter, the study continued enrolling new subjects and the company expects to report the initial data from this study in early 2023.
- Phase 1b Study of VK0214 in X-ALD Ongoing; Data Expected in 1H 2023. 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 neurogenerative disease for which there are currently no pharmacologic treatment options.
In 2020, Viking initiated a randomized, double-blind, placebo-controlled, SAD and MAD Phase 1 study of VK0214 in healthy volunteers. This study successfully achieved its primary and secondary endpoints as VK0214 demonstrated dose-dependent exposures, no evidence of accumulation, and a half-life consistent with anticipated once daily dosing. VK0214 demonstrated encouraging safety and tolerability in this study, with no SAEs observed and no differences reported for gastrointestinal side effects such as nausea or diarrhea among subjects treated with VK0214 compared with placebo. After 14 days of treatment, subjects who received VK0214 also experienced reductions in LDL-cholesterol, triglycerides, apolipoprotein B and lipoprotein (a). Many of these lipid reductions achieved statistical significance, though the study was not powered to demonstrate statistical significance on lipid assessments.
In 2021, 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 randomized, double-blind, placebo-controlled multi-center study in adult male patients with AMN. The primary objectives of the study are to evaluate the safety and tolerability of VK0214 administered orally, once-daily for 28-days. The study also includes an evaluation of the pharmacokinetics of VK0214 in AMN patients, as well as an exploratory assessment of changes in plasma levels of very long chain fatty acids.
The company expects to report the results from this trial in 1H 2023.
- Strong balance sheet to support advancement of clinical programs into late stage development. Viking ended the third quarter of 2022 with $155 million in cash, cash equivalents and short-term investments.
- Upcoming investor events. Viking management will participate in the following upcoming investor events:
Stifel 2022 Healthcare Conference
New York City, NY
November 15 – 16, 2022
BIO One-on-One Partnering, JPM Week
San Francisco, CA
January 9 – 12, 2023
Third Quarter and Nine Month Financial Highlights
Third Quarter Ended September 30, 2022 and 2021
Research and development expenses for the three months ended September 30, 2022 were $12.0 million compared to $10.8 million for the same period in 2021. The increase was primarily due to increased expenses related to manufacturing for the company’s drug candidates, salaries and benefits, pre-clinical studies and stock-based compensation, partially offset by decreased expenses related to the company’s clinical studies and third-party consultants.
General and administrative expenses for the three months ended September 30, 2022 were $4.2 million compared to $2.6 million for the same period in 2021. The increase was primarily due to increased expenses related to legal services, stock-based compensation and salaries and benefits.
For the three months ended September 30, 2022, Viking reported a net loss of $15.8 million, or $0.21 per share, compared to a net loss of $13.2 million, or $0.17 per share, in the corresponding period in 2021. The increase in net loss and net loss per share for the three months ended September 30, 2022 was primarily due to the increase in research and development expenses and general and administrative expenses, noted previously, compared to the same period of 2021.
Nine Months Ended September 30, 2022 and 2021
Research and development expenses for the nine months ended September 30, 2022 were $38.1 million compared to $35.1 million for the same period in 2021. The increase was primarily due to increased expenses related to manufacturing for the company’s drug candidates, salaries and benefits and stock-based compensation, partially offset by decreased expenses related to the company’s clinical studies, pre-clinical studies and third-party consultants.
General and administrative expenses for the nine months ended September 30, 2022 were $12.0 million compared to $8.0 million for the same period in 2021. The increase was primarily due to increased expenses related to legal services, stock-based compensation and salaries and benefits.
For the nine months ended September 30, 2022, Viking reported a net loss of $49.3 million, or $0.64 per share, compared to a net loss of $42.6 million, or $0.55 per share, in the corresponding period in 2021. The increase in net loss and net loss per share for the nine months ended September 30, 2022 was primarily due to the increase in research and development expenses and general and administrative expenses, noted previously.
Balance Sheet as of September 30, 2022
At September 30, 2022, Viking held cash, cash equivalents and short-term investments of $155 million, compared to $202 million as of December 31, 2021.