Viking Therapeutics Reports Second Quarter 2016 Financial Results And Provides Corporate Update
SAN DIEGO, Aug. 10, 2016 /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 second quarter of 2016, and provided an update on its clinical pipeline and other corporate developments.
Highlights from, and Subsequent to, the Quarter Ended June 30, 2016
"During the second quarter, we made important progress with key pipeline programs, including our two Phase 2 clinical programs, VK5211 for hip fracture and VK2809 for hypercholesterolemia and fatty liver disease," stated Brian Lian, Ph.D., chief executive officer of Viking. "We completed the opening of all U.S. sites for VK5211, expanded the study to Europe, and enrolled the first European patients. We also made excellent progress toward the initiation of our upcoming VK2809 Phase 2 study, and expect to begin screening patients for enrollment this month. Both programs continue to advance, and we expect to report data in the first half of 2017. In addition to our clinical progress, we achieved an early but important preclinical milestone and announced positive results from a proof-of-concept study of VK0214 in an in vivo model of X-linked adrenoleukodystrophy (X-ALD). Finally, during the second quarter we completed a successful offering of common stock and warrants, raising $10.8 million and further strengthening our balance sheet."
Pipeline and Corporate Highlights
- Completed opening all planned U.S. sites for the ongoing Phase 2 clinical trial of VK5211 in hip fracture recovery patients. VK5211 is a novel, orally available, non-steroidal small molecule selective androgen receptor modulator (SARM) which has been shown to have a stimulatory effect on lean body mass and bone mineral density, and may offer significant benefits to patients recovering from hip fracture surgery. The company also began its previously-announced expansion of this study to include up to 17 EU sites. Viking currently expects the trial to be completed in 2Q17.
- Finalized preparations to initiate a Phase 2 clinical trial of VK2809 in hypercholesterolemia and fatty liver disease. VK2809 is a novel, orally available small molecule thyroid receptor agonist that possesses selectivity for liver tissue as well as the beta receptor subtype, suggesting promise in this patient population. The upcoming trial will be a randomized, placebo-controlled, parallel group, multicenter trial in up to 80 patients, designed to evaluate the effects of VK2809 on plasma lipids and liver fat following 12 weeks of dosing. Viking expects to begin screening patients for this trial later this month, and to complete the study in 2Q17.
- Presented positive data from a Phase 1b clinical trial of VK2809 in subjects with mild hypercholesterolemia at the 65th Annual Scientific Session & Expo of the American College of Cardiology (ACC). The results demonstrated substantial and clinically meaningful reductions in subjects' low-density lipoprotein cholesterol (LDL-C), triglycerides, and improvements in other measures following 14 days of treatment. The presentation received a prestigious Best Poster award from the ACC.
- Announced positive top-line results from an in vivo proof-of-concept study of VK0214 for X-linked adrenoleukodystrophy (X-ALD). This study showed that VK0214 rapidly reduced plasma very long chain fatty acid (VLCFA) levels by more than 25% in treated animals compared with vehicle controls (p < 0.01). The study successfully achieved its primary objective, which was to demonstrate the ability of VK0214 to lower plasma VLCFA levels after six weeks of treatment. As the accumulation of VLCFAs is believed to contribute to the underlying pathology of X-ALD, these data provide support for the continued evaluation of VK0214 in this indication. Detailed results will be presented at the upcoming meeting of the American Thyroid Association, as outlined below.
- Completed a public offering of common stock and warrants, including the underwriters' full exercise of the over-allotment option, generating gross proceeds of approximately $10.8 million.
Upcoming Data Presentations from Pipeline Programs
- VK5211: A Phase 1 Study of the Selective Androgen Receptor Modulator VK5211 in Elderly Males and Females
Poster presentation
5th Fragility Fracture Network Global Congress
Rome, September 1, 2016 - VK5211: Design of a Clinical Study to Determine the Effects of the Selective Androgen Receptor Modulator VK5211 on Hip Fracture Recovery in Elderly Subjects
Poster and oral presentation Named A Top 15 Conference Poster
5th Fragility Fracture Network Global Congress
Rome, September 2, 2016 - VK0214: Evaluation of the Thyroid Hormone Receptor Agonist VK0214 in an In Vivo Model of X-Linked Adrenoleukodystrophy
Poster presentation
86th Annual Meeting of the American Thyroid Association
Denver, Colorado, September 23, 2016 - VK2809: Reduction of Atherogenic Lipoprotein (a) and Apolipoprotein B in Humans With the Selective Thyroid Receptor Beta Agonist VK2809
Poster presentation
American Heart Association Scientific Sessions 2016
New Orleans, Louisiana, November 14, 2016
Financial Highlights
Second Quarter Ended June 30, 2016 and 2015
Research and development expenses for the three months ended June 30, 2016 were $2.4 million compared to $1.1 million for the same period in 2015. The increase was primarily due to increased activities related to our ongoing VK5211 Phase 2 clinical trial and planning for the initiation of our VK2809 Phase 2 clinical trial.
General and administrative expenses for the three months ended June 30, 2016 decreased to $1.2 million from $1.5 million for the same period in 2015. The decrease was primarily due to a decrease in stock-based compensation offset by increased staffing and other costs associated with being a publicly traded company following the close of the company's initial public offering in May 2015.
For the three months ended June 30, 2016, Viking reported a net loss of $3.7 million, or $0.22 per share, compared to a net loss of $7.9 million, or $1.07 per share, in the corresponding period in 2015. The decrease in net loss for the three months ended June 30, 2016 was primarily due to the change in fair value of accrued license fees expense of $4.4 million in 2015 with no comparable expense in 2016 and a decrease in general and administrative expenses offset by an increase in research and development expenses.
Six Months Ended June 30, 2016 and 2015
Research and development expenses for the six months ended June 30, 2016 were $4.2 million compared to $1.2 million for the same period in 2015. The increase was primarily due to increased activities related to our ongoing VK5211 Phase 2 clinical trial and planning for the initiation of our VK2809 Phase 2 clinical trial and increased staffing.
General and administrative expenses for the six months ended June 30, 2016 increased to $2.6 million compared to $1.8 million for the same period in 2015. The increase was primarily due to increased staffing and other costs associated with being a publicly traded company following the close of the company's initial public offering in May 2015.
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