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Conference call scheduled for 4:30 p.m. ET today
SAN DIEGO, Oct. 26, 2022 /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 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
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, 2023Third 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.Conference Call
Management will host a conference call to discuss the company's third quarter 2022 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 November 2, 2022 by dialing (877) 344-7529 from the U.S. or (412) 317-0088 from outside the U.S. and entering conference ID # 8398407. Those interested in listening to the conference call live via the internet may do so by visiting the Webcasts page of Viking's website at http://ir.vikingtherapeutics.com/webcasts. An archive of the webcast will also be available on the Webcasts page of the company's website for 30 days.About Viking Therapeutics, Inc.
Viking Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel 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, which is currently being evaluated in a Phase 2b study for the treatment of biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis. In a Phase 2a trial for the treatment of non-alcoholic fatty liver disease (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 VK2735, a novel dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors for the potential treatment of various metabolic disorders. VK2735 is currently being evaluated in a Phase 1 clinical trial. In the rare disease space, the company is developing VK0214, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the potential treatment of X-linked adrenoleukodystrophy (X-ALD). VK0214 is currently being evaluated in a Phase 1b clinical trial in patients with the adrenomyeloneuropathy (AMN) form of X-ALD. The company holds exclusive worldwide rights to a portfolio of five therapeutic programs, including VK2809 and VK0214, which are based on small molecules licensed from Ligand Pharmaceuticals Incorporated.
For more information about Viking Therapeutics, please visit www.vikingtherapeutics.com. 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 clinical and preclinical development programs. 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 VK2735, VK0214, VK2809, and the company's other incretin receptor agonists; 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, 2021, and subsequent Quarterly Reports on Form 10-Q, including the risk factors set forth in those filings. 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.
Viking Therapeutics, Inc.
Statements of Operations and Comprehensive Loss
(In thousands, except per share amounts)
(Unaudited)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2022
2021
2022
2021
Revenues
$
—
$
—
$
—
$
—
Operating expenses:
Research and development
11,959
10,795
38,056
35,134
General and administrative
4,237
2,608
12,016
8,038
Total operating expenses
16,196
13,403
50,072
43,172
Loss from operations
(16,196)
(13,403)
(50,072)
(43,172)
Other income (expense):
Amortization of financing costs
(27)
35
(51)
(6)
Interest income, net
450
125
857
544
Realized loss on investments, net
-
—
(42)
—
Total other income, net
423
160
764
538
Net loss
(15,773)
(13,243)
(49,308)
(42,634)
Other comprehensive loss, net of tax:
Unrealized loss on securities
110
19
(813)
(116)
Foreign currency translation loss
(223)
—
(399)
—
Comprehensive loss
$
(15,886)
$
(13,224)
$
(50,520)
$
(42,750)
Basic and diluted net loss per common share
$
(0.21)
$
(0.17)
$
(0.64)
$
(0.55)
Weighted-average shares used to compute basic and diluted net loss per share
76,505
78,009
76,917
76,908
Viking Therapeutics, Inc.
Balance Sheets
(In thousands, except share and per share amounts)
September 30,
2022
December 31,
2021
(Unaudited)
Assets
Current assets:
Cash and cash equivalents
$
29,408
$
26,371
Short-term investments – available for sale
125,615
175,732
Prepaid clinical trial and preclinical study costs
9,167
7,806
Prepaid expenses and other current assets
956
619
Total current assets
165,146
210,528
Right-of-use assets
1,489
25
Deferred financing costs
15
76
Deposits
33
33
Total assets
$
166,683
$
210,662
Liabilities and stockholders' equity
Current liabilities:
Accounts payable
$
3,142
$
1,444
Other accrued liabilities
10,620
7,305
Lease liability, current
299
29
Total current liabilities
14,061
8,778
Lease liability, net of current portion
1,337
—
Total long-term liabilities
1,337
—
Total liabilities
15,398
8,778
Commitments and contingencies (Note 8)
Stockholders' equity:
Preferred stock, $0.00001 par value: 10,000,000 shares authorized at September 30, 2022 and December 31, 2021; no shares issued and outstanding at September 30, 2022 and December 31, 2021
—
—
Common stock, $0.00001 par value: 300,000,000 shares authorized at September 30, 2022 and December 31, 2021; 76,688,478 and 78,248,401 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively
1
1
Additional paid-in capital
432,330
425,614
Accumulated deficit
(272,490)
(223,182)
Accumulated other comprehensive loss
(1,761)
(549)
Treasury stock at cost, 2,193,251 shares at September 30, 2022, no shares at December 31, 2021
(6,795)
—
Total stockholders' equity
151,285
201,884
Total liabilities and stockholders' equity
$
166,683
$
210,662
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SOURCE Viking Therapeutics, Inc.