Viking 2018 financials and corporate update

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, 2018, and provided an update on its clinical pipeline and other corporate developments.

Highlights from the Quarter, and Subsequent to December 31, 2018:

“The past year has been a transformative period for Viking, and we are excited to continue this momentum in 2019,” stated Brian Lian, Ph.D., chief executive officer of Viking Therapeutics.  “We were particularly pleased in 2018 to have presented positive Phase 2 data from our novel thyroid receptor beta agonist VK2809 in non-alcoholic fatty liver disease at the AASLD conference, and honored that these results were featured in the Best of AASLD conference highlights.  We plan to present additional, new results from this study at the upcoming EASL conference in April, and remain on-track to file an IND to initiate a study in biopsy-confirmed NASH later this year.  In addition, pre-IND work for our second thyroid receptor agonist VK0214 continues to progress, and we plan to file an IND to initiate clinical development by the end of the year.  Thanks to successful fundraising efforts in 2018, we ended the year with more than $300 million on our balance sheet, and are now capitalized to reach major inflection points for multiple programs.  Entering 2019, we are focused on executing our operating plans and enthusiastic about the future development of our pipeline.”

Pipeline and Corporate Highlights

• Phase 2 study of VK2809 in patients with NAFLD and elevated LDL-C highlighted at 2018 AASLD. VK2809 is a novel, orally available small molecule thyroid receptor antagonist that possesses selectivity for liver tissue, as well as the beta receptor subtype, suggesting promise in certain metabolic and liver diseases, including non-alcoholic steatohepatitis (NASH). In November 2018, the company’s positive top-line results from a 12-week Phase 2 study of VK2809 were presented at the annual meeting of the American Association for the Study of Liver Diseases (AASLD) as part of the Late-Breaking Abstract Oral Session. The trial findings were also named to the Best of AASLD, which highlighted the contributions of particular importance at the annual meeting. The company is currently preparing to initiate a Phase 2b study of VK2809 in biopsy-confirmed NASH, which is anticipated to begin in the second half of 2019.
• Additional VK2809 Phase 2 data to be presented at the Late-Breaker poster session of the upcoming 2019 EASL conference. The company recently received additional data from the low-dose 5 mg cohort in the Phase 2 trial of VK2809 trial in NAFLD and hypercholesterolemia. The results demonstrated that patients receiving VK2809 experienced statistically significant reductions in liver fat content relative to placebo, as well as statistically significant improvements in response rates, defined by the proportion of patients experiencing at least a 30% or 50% relative reduction in liver fat, compared with placebo. Consistent with prior data from the 10 mg cohorts, VK2809 was well tolerated when dosed at 5 mg daily, and no serious adverse events were reported among patients receiving either VK2809 or placebo. These results will be presented at the Late-Breaker poster session at the upcoming annual meeting of the European Association for the Study of Liver (EASL), April 11-14, 2019 in Vienna, Austria.
• IND-enabling work for VK0214 in X-linked adrenoleukodystrophy (X-ALD) progressing, IND filing planned in 2019. VK0214 is a novel, orally available small molecule thyroid receptor agonist that possesses selectivity for the beta receptor subtype. The company is continuing to progress VK0214 through IND-enabling work, with a current goal of filing an IND in 2019 to allow initiation of a proof-of-concept study in X-ALD.
• Phase 2 study results of VK5211 in patients recovering from hip fracture highlighted at ASBMR 2018 Annual Meeting. VK5211 is an orally available, non-steroidal selective androgen receptor modulator (SARM) designed to selectively stimulate muscle and bone formation with reduced activity in peripheral tissues such as skin and prostate. In the fourth quarter, Viking announced positive new findings from the company’s Phase 2 trial of VK5211 in patients recovering from hip fracture during the plenary session of the Annual Meeting of the American Society for Bone and Mineral Research (ASBMR). In addition, the abstract received the 2018 Most Outstanding Clinical Abstract Award from the conference organizers. Among the notable results from this study was the observation that patients receiving VK5211 gained weight, added muscle, and lost fat content compared with patients receiving placebo. The company is continuing to explore partnering and licensing opportunities that will allow us to optimize the value of VK5211.
• Balance sheet sufficient to support operations through at least 2021. In 2018, Viking raised approximately $315 million in gross proceeds through the issuance of common stock, and completed 2018 with approximately $302 million in cash, cash equivalents, and short-term investments. The company currently expects these resources to be sufficient to support operations through at least the 2021 timeframe.
• Upcoming investor events. Viking management will participate in the following March investor events:

31^st Annual ROTH Conference
Updated Time/Date: 12:00 p.m. PT on Monday, March 18, 2019 (webcast available)
Location: Ritz-Carlton Laguna Niguel, Dana Point, CA
Room: Pink – Salon 5

Oppenheimer’s 29^th Annual Healthcare Conference
Time/Date: 11:30 a.m. ET on Wednesday, March 20, 2019
Location: Westin New York Grand Central Hotel, New York
Room: Consulate Room

Q4 and Full-Year 2018 Financial Highlights

Fourth Quarter Ended December 31, 2018 and 2017

Research and development expenses for the three months ended December 31, 2018were $5.1 million compared to $3.0 million for the same period in 2017.  The increase was primarily due to increased pre-clinical study efforts, manufacturing expenses related to our drug candidates, use of third party consultants and stock-based compensation, partially offset by a decrease in clinical study expenses.

General and administrative expenses for the three months ended December 31, 2018were $1.9 million compared to $1.4 million for the same period in 2017.  The increase was primarily due to increased expenses related to stock-based compensation, salaries and benefits, and legal and patent expenses.

For the three months ended December 31, 2018, Viking reported a net loss of $5.2 million, or $0.07 per share, compared to a net loss of $4.1 million, or $0.14 per share, in the corresponding period in 2017.  The increase in net loss for the three months ended December 31, 2018 was primarily due to the increase in research and development expenses noted previously, partially offset by an increase in other income related to the increase in interest income. The decrease in net loss per share for the three months ended December 31, 2018 is primarily driven by the additional shares outstanding at December 31, 2018 versus those outstanding at December 31, 2017, given the additional shares issued by the Company during 2018, primarily through public equity offerings.

Twelve Months Ended December 31, 2018 and 2017

Research and development expenses for the twelve months ended December 31, 2018 were $19.0 million compared to $13.7 million for the same period in 2017.  The increase was primarily due to increased expenses related to pre-clinical study efforts, use of third party consultants, stock-based compensation, and manufacturing related to our drug candidates, partially offset by a decrease in clinical study expenses.

General and administrative expenses for the twelve months ended December 31, 2018 were $7.1 million compared to $5.3 million for the same period in 2017.  The increase was primarily due to increased expenses related to stock-based compensation, salaries and benefits, professional services, use of third party consultants, insurance, legal and patent expenses, and franchise taxes.

For the twelve months ended December 31, 2018, Viking reported a net loss of $22.1 million, or $0.38 per share, compared to a net loss of $20.6 million, or $0.79 per share, in the corresponding period in 2017.  The increase in net loss for the twelve months ended December 31, 2018 was primarily due to the increase in research and development expenses and general and administrative expenses noted previously offset by an increase in other income related to the decrease in the fair value of the debt conversion feature liability, as well as an increase in interest income.  The decrease in net loss per share for the twelve months ended December 31, 2018 is primarily driven by the additional shares outstanding at December 31, 2018 versus those outstanding at December 31, 2017, given the additional shares issued by the Company during 2018, primarily through public equity offerings.

https://www.biospace.com/article/releases/viking-therapeutics-reports-fourth-quarter-and-year-end-2018-financial-results-and-provides-corporate-update/