On April 30, 2020 Viking Therapeutics, Inc. (Viking) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, reported its financial results for the first quarter ended March 31, 2020, and provided an update on its clinical pipeline and other corporate developments (Press release, Viking Global Investors, APR 30, 2020, View Source [SID1234556873]).

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Highlights from the Quarter Ended March 31, 2020:

"During the first quarter, we made continued progress on our Phase 2b VOYAGE clinical trial evaluating VK2809 in patients with biopsy-confirmed NASH and fibrosis," stated Brian Lian, Ph.D., chief executive officer of Viking Therapeutics. "We have been proactive in implementing steps to mitigate the potential impact of the coronavirus pandemic, and are closely monitoring this evolving challenge. We are encouraged that enrolled patients continue to receive treatment, new patients continue to enroll, and clinical site activations remain ongoing. That said, the pandemic has disrupted each of these activities on some level. We currently anticipate completion of enrollment in VOYAGE in the first half of 2021. In the first quarter, we also made progress with our second thyroid hormone receptor beta agonist, VK0214, for the treatment of X-linked adrenoleukodystrophy. We currently expect to submit an IND for VK0214 this summer and initiate clinical studies with this candidate in the third quarter. Finally, we remain vigilant in managing our balance sheet and ended the quarter with $269 million in cash and cash equivalents, which we believe provides sufficient runway to accomplish multiple development milestones."

Pipeline and Corporate Highlights

Enrollment continues in Phase 2b VOYAGE study evaluating VK2809 in biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis. 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, and has demonstrated promising therapeutic potential in a range of lipid disorders, including NASH. In September 2018, the company announced positive results from a 12-week Phase 2 trial of VK2809 in patients with hypercholesterolemia and non-alcoholic fatty liver disease (NAFLD). Patients receiving VK2809 in this study demonstrated potent reductions in liver fat content and plasma lipids compared with patients receiving placebo.

In 2019, the company initiated the Phase 2b VOYAGE trial. This trial 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 ranging from stages F1 to F3. The study is targeting enrollment of approximately 340 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. Enrollment is continuing at U.S. sites, with ex-U.S. sites expected to open later this year.

Additional data from VK2809 Phase 2 trial to be highlighted in podium presentation at EASL. An abstract describing additional data from the company’s completed 12-week Phase 2 trial of VK2809 in patients with NAFLD and hypercholesterolemia has been selected for oral presentation at the 2020 International Liver Congress, hosted by the European Association for the Study of the Liver (EASL). Due to the COVID-19 pandemic, this event has been postponed until August 25-28, 2020.

IND-enabling work near completion for VK0214 for the treatment of X-ALD – IND filing expected mid-year. VK0214 is being evaluated as a potential treatment for X-linked adrenoleukodystrophy (X-ALD), a devastating disease for which there is currently no therapeutic treatment. X-ALD is caused by a defect in the ABCD1 peroxisomal transporter. This defect can result in an accumulation of very long chain fatty acids in plasma and tissue, which is believed to contribute to the severe cerebral and motor neuron toxicities that are characteristic of the disease.

To date, findings from in vitro and in vivo studies have demonstrated that administration of VK0214 results in a significant reduction of very long chain fatty acids in both plasma and tissue, potentially leading to a therapeutic benefit. These promising results were achieved through the company’s ongoing collaboration with the Kennedy Krieger Institute – one of the world’s leading X-ALD research centers. The company plans to file an IND in mid-2020 and initiate clinical studies in the third quarter.

Balance sheet remains strong with approximately $270 million in cash. Viking completed the first quarter of 2020 with $269.2 million in cash, cash equivalents and short-term investments.

Upcoming investor events. Viking management will participate in the following upcoming investor events:
6th Annual SunTrust Robinson Humphrey Life Science Summit
Date: May 5- 6, 2020
Virtual Format

UBS Global Healthcare Conference
Dates: May 18 – 20, 2020
Virtual Format

Jefferies Global Healthcare Conference
Dates: June 2 –4, 2020
Virtual Format

Raymond James Healthcare Conference
Dates: June 16 – 17, 2020
Virtual Format

Q1 2020 Financial Highlights

Research and development expenses for the three months ended March 31, 2020 were $8.0 million compared to $4.5 million for the same period in 2019. The increase was primarily due to increased expenses related to our clinical studies, with the initiation of the Phase 2b VOYAGE study in November 2019, pre-clinical studies, and manufacturing for our drug candidates, partially offset by decreased expenses related to services provided by third-party consultants.

General and administrative expenses for the three months ended March 31, 2020 were $3.0 million compared to $2.3 million for the same period in 2019. The increase was primarily due to increased expenses related to stock-based compensation, legal expenses, and salaries and benefits, partially offset by decreased expenses related to services provided by third-party consultants and professional fees.

For the three months ended March 31, 2020, Viking reported a net loss of $9.7 million, or $0.13 per share, compared to a net loss of $4.9 million, or $0.07 per share, in the corresponding period in 2019. The increase in net loss and net loss per share for the three months ended March 31, 2020 was primarily due to increased research and development and general and administrative expenses noted previously, as well as decreased interest income due to the decline in interest rates throughout the first quarter of 2020 as compared to prevailing interest rates during the first quarter of 2019.

Balance Sheet as of March 31, 2020

At March 31, 2020, Viking held cash, cash equivalents and short-term investments totaling $269.2 million and had 72,562,863 shares of common stock outstanding.

Conference Call

Management will host a conference call to discuss the company’s first quarter 2020 financial results today at 4:30 pm Eastern. To participate in the conference call, please dial (844) 850-0543 from the U.S. or (412) 317-5199 from outside the U.S. In addition, following the completion of the call, a telephone replay will be accessible until May 7, 2020 by dialing (877) 344-7529 from the U.S. or (412) 317-0088 from outside the U.S. and entering conference ID # 10141875. Those interested in listening to the conference call live via the internet may do so by visiting the Investor Relations section of Viking’s website at www.vikingtherapeutics.com. An archive of the webcast will be available for 30 days on the company’s website at www.vikingtherapeutics.com.