Viking Therapeutics Reports Fourth Quarter and Year-End 2019

|Feb 26|magazine36 min read

SAN DIEGO, Feb. 26, 2020 /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 fourth quarter and year ended December 31, 2019, and provided an update on its clinical pipeline and other corporate developments.

Highlights from the Quarter and Year-Ended December 31, 2019:

"We made excellent progress with our lead programs in 2019, setting the company up for an exciting year in 2020," stated Brian Lian, Ph.D., chief executive officer of Viking Therapeutics.  "In the fourth quarter, we announced the initiation of the VOYAGE Phase 2b study of our novel thyroid receptor agonist VK2809, for non-alcoholic steatohepatitis (NASH).  We are currently in the process of executing this trial in the U.S. and anticipate opening sites outside the U.S. in the months ahead.  We were also recently informed that an abstract highlighting additional data from the prior 12-week Phase 2 study of VK2809 has been selected for a podium presentation at the upcoming International Liver Conference, or EASL, in April.  We look forward to sharing the data in this prestigious forum.  We've also made progress with our second thyroid receptor beta agonist, VK0214, for the treatment of X-linked adrenoleukodystrophy (X-ALD), and we expect to file an IND in the second quarter to initiate clinical development with this molecule.  The continued advancement of these programs is supported by our strong balance sheet.  We ended the year with $275 million in cash and equivalents, which we believe is sufficient to support development of our pipeline through multiple clinical milestones."

Pipeline and Corporate Highlights

  • Phase 2b VOYAGE study underway evaluating VK2809 in biopsy-confirmed NASH. 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). This trial achieved its primary and secondary endpoints, demonstrating potent reductions in liver fat content and plasma lipids among patients receiving VK2809 compared with placebo.


    During 2019, the company completed multiple studies to support long-term dosing of VK2809 in humans. The results of these studies, along with additional clinical and non-clinical data, formed the basis of an IND application that was filed with the FDA's Division of Gastrointestinal and Inborn Errors Products (DGIEP). Following clearance of the IND, in November 2019 Viking initiated the Phase 2b VOYAGE trial evaluating VK2809 in patients with biopsy-confirmed NASH.


    The VOYAGE 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 will target 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 underway at U.S. sites, with ex-U.S. sites expected to open later this year.
  • Additional VK2809 Phase 2 data to be highlighted in podium presentation at EASL. The company was recently informed that an abstract describing additional data from the completed 12-week Phase 2 trial of VK2809 in patients with NAFLD and hypercholesterolemia has been accepted for oral presentation at the 2020 International Liver Congress, hosted by the European Association for the Study of the Liver (EASL). The presentation is scheduled for April 17, 2020 at 4:30 pm CET.
  • VK0214 IND filing for X-ALD expected in 2Q20. VK0214 is being evaluated as a potential treatment for X-linked adrenoleukodystrophy (X-ALD), a devastating disease for which there is 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. IND-enabling work for VK0214 continues to advance and the company plans to file the IND in 2Q20, followed by initiation of a proof-of-concept study in humans.
  • Balance sheet remains strong with approximately $275 million in cash. Viking completed the fourth quarter of 2019 with $275.6 million in cash, cash equivalents and short-term investments.
  • Upcoming investor events. Viking management will participate in the following upcoming investor events:

Raymond James & Associates' 41st Annual Institutional Investors Conference
Date: March 1- 4, 2020
Location: JW Marriott Grand Lakes, Orlando, FL

Cowen 40th Annual Healthcare Conference
Dates: March 2 – 4, 2020
Location: Boston Marriott Copley Place, Boston, MA

32nd Annual Roth Conference
Dates: March 15 – 17, 2020
Location: Ritz Carlton, Dana Point, CA

Oppenheimer 30th Annual Healthcare Conference
Dates: March 17 - 18, 2020
Location: InterContinental New York Barclay, New York, NY

William Blair Biotech Focus Conference
Dates: April 1 - 2, 2020
Location: St. Regis Hotel, New York, NY

Needham Healthcare Conference
Dates: April 14 - 15, 2020
Location: Westin Grand Central Hotel, New York, NY

H.C. Wainwright & Co. Global Life Sciences Conference
Dates: April 19 - 21, 2020
Location: Grosvenor House, London, UK

Q4 and Full-Year 2019 Financial Highlights

Fourth Quarter Ended December 31, 2019 and 2018

Research and development expenses for the three months ended December 31, 2019 were $6.5 million compared to $5.1 million for the same period in 2018.  The increase was primarily due to increased expenses related to clinical studies, with the initiation of the VOYAGE study during the quarter and manufacturing for our drug candidates, partially offset by decreased expenses related to pre-clinical studies and services provided by third-party consultants. 

General and administrative expenses for the three months ended December 31, 2019 were $2.4 million compared to $1.9 million for the same period in 2018.  The increase was primarily due to increased expenses related to stock-based compensation and professional fees.

For the three months ended December 31, 2019, Viking reported a net loss of $7.5 million, or $0.10 per share, compared to a net loss of $5.2 million, or $0.07 per share, in the corresponding period in 2018.  The increase in net loss and net loss per share for the three months ended December 31, 2019 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 2019 as compared to prevailing interest rates during the fourth quarter of 2018.

Twelve Months Ended December 31, 2019 and 2018

Research and development expenses for the twelve months ended December 31, 2019 were $23.6 million compared to $19.0 million for the same period in 2018.  The increase was primarily due to increased expenses related to manufacturing for our drug candidates, clinical studies, services provided by third-party consultants and salaries and benefits, partially offset by decreased expenses related to pre-clinical studies. 

General and administrative expenses for the twelve months ended December 31, 2019 were $9.1 million compared to $7.1 million for the same period in 2018.  The increase was primarily due to increased expenses related to stock-based compensation, services provided by third-party consultants, insurance expense, legal and patent expenses and professional fees.  

For the twelve months ended December 31, 2019, Viking reported a net loss of $25.8 million, or $0.36 per share, compared to a net loss of $22.1 million, or $0.38 per share, in the corresponding period in 2018.  The increase in net loss for the twelve months ended December 31, 2019 was primarily due to increased research and development and general and administrative expenses noted previously, partially offset by increased interest income as well as the elimination of expenses related to the change in fair value of the debt conversion feature liability due to the repayment of the promissory note issued to Ligand Pharmaceuticals, Inc. in May 2018.  The decrease in net loss per share for the twelve months ended December 31, 2019 was primarily driven by the additional weighted average shares outstanding at December 31, 2019 versus those outstanding at December 31, 2018, given the public equity financings that occurred during 2018.

Balance Sheet as of December 31, 2019

At December 31, 2019, Viking held cash, cash equivalents and short-term investments totaling $275.6 million and had 72,413,602 shares of common stock outstanding. 

Conference Call

Management will host a conference call to discuss the company's fourth quarter and year-end 2019 financial results today at 4:30 pm Eastern.  To participate on 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 March 5, 2020 by dialing (877) 344-7529 from the U.S. or (412) 317-0088 from outside the U.S. and entering conference ID # 10139005.  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.

About Viking Therapeutics, Inc. 

Viking Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel, orally available, first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders.  Viking's research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients' lives.  The company's clinical programs include VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders, is currently being evaluated in a Phase 2b study for the treatment of biopsy-confirmed NASH.  In a Phase 2 trial for the treatment of NAFLD and elevated LDL-C, patients who received VK2809 demonstrated statistically significant reductions in LDL-C and liver fat content compared with patients who received placebo.  The company is also developing VK0214, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of X-linked adrenoleukodystrophy (X-ALD).

Viking's other programs include VK5211, an orally available, non-steroidal selective androgen receptor modulator (SARM).  In a Phase 2 trial in patients recovering from hip fracture, patients who received VK5211 experienced significant improvements in measures of lean body mass compared with patients who received placebo.  Other programs also include VK0612, a first-in-class, orally available drug candidate in Phase 2 development for the treatment of type 2 diabetes as well as two earlier-stage programs targeting metabolic diseases and anemia.  The company holds exclusive worldwide rights to a portfolio of five therapeutic programs, including those noted above, which are based on small molecules licensed from Ligand Pharmaceuticals Incorporated.

Follow Viking on Twitter @Viking_VKTX.

Forward-Looking Statements

This press release contains forward-looking statements regarding Viking Therapeutics, Inc., under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its development activities, timelines and milestones, including the Company's expected timing for an IND filing in X-ALD for VK0214 and plans for opening sites outside the U.S. in the Company's VOYAGE Phase 2b study, as well as the company's goals and plans regarding VK2809 and its prospects. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: risks associated with the success, cost and timing of Viking's product candidate development activities and clinical trials, including those for VK2809 and VK0214; risks that prior clinical and preclinical results may not be replicated; risks regarding regulatory requirements; and other risks that are described in Viking's most recent periodic reports filed with the Securities and Exchange Commission, including Viking's Annual Report on Form 10-K for the year ended December 31, 2019, including the risk factors set forth in that filing. These forward-looking statements speak only as of the date hereof.  Viking disclaims any obligation to update these forward-looking statements except as required by law.

Statements of Operations and Comprehensive Loss

 

(In thousands, except per share amounts)




Three Months Ended December 31,



Year Ended December 31,




2019

(Unaudited)



2018

(Unaudited)



2019



2018


Revenues


$



$



$



$


Operating expenses:

















Research and development



6,451




5,089




23,559




19,040


General and administrative



2,422




1,948




9,128




7,121


Total operating expenses



8,873




7,037




32,687




26,161


Loss from operations



(8,873)




(7,037)




(32,687)




(26,161)


Other income (expense):

















Change in fair value of debt conversion feature liability












1,398


Amortization of debt discount












(404)


Amortization of financing costs



(46)




(30)




(146)




(120)


Interest income, net



1,469




1,839




7,050




3,236


Realized gain (loss) on investments






(12)




4




(12)


Total other income, net



1,423




1,797




6,908




4,098


Net loss



(7,450)




(5,240)




(25,779)




(22,063)


Other comprehensive loss, net of tax:

















Unrealized gain (loss) on securities



(145)




(306)




435




(403)


Comprehensive loss


$

(7,595)



$

(5,546)



$

(25,344)



$

(22,466)


Basic and diluted net loss per share


$

(0.10)



$

(0.07)



$

(0.36)



$

(0.38)


Weighted-average shares used to compute basic and diluted net loss per share



72,115




71,340




71,959




57,580


 

Viking Therapeutics, Inc.

Balance Sheets




(In thousands, except share and per share amounts)






December 31,

2019



December 31,

2018









Assets









Current assets:









Cash and cash equivalents


$

8,377



$

24,779


Short-term investments – available for sale



267,261




276,741


Prepaid clinical trial and preclinical study costs



7,458




335


Prepaid expenses and other current assets



405




278


Total current assets



283,501




302,133


Right-of-use assets



598





Deferred public offering and other financing costs



128




150


Deposits



29




29


Total assets


$

284,256



$

302,312


Liabilities, convertible notes and stockholders' equity









Current liabilities:









Accounts payable


$

2,431



$

959


Other accrued liabilities



4,044




3,591


Lease liability, current



302





Total current liabilities



6,777




4,550


Deferred rent






12


Lease liability, net of current portion



360





Total long-term liabilities



360




12


Total liabilities



7,137




4,562


Commitments and contingencies









Stockholders' equity:









Preferred stock, $0.00001 par value: 10,000,000 shares authorized at December 31, 2019 and 2018; no shares issued and outstanding at December 31, 2019 and 2018







Common stock, $0.00001 par value: 300,000,000 shares authorized at December 31, 2019 and 2018; 72,413,602 shares issued and outstanding at December 31, 2019 and 71,742,043 shares issued and outstanding at December 31, 2018



1




1


Additional paid-in capital



405,803




401,090


Accumulated deficit



(128,697)




(102,918)


Accumulated other comprehensive income (loss)



12




(423)


Total stockholders' equity



277,119




297,750


Total liabilities and stockholders' equity


$

284,256



$

302,312


 

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SOURCE Viking Therapeutics, Inc.