Conference call scheduled for 4:30 p.m. ET today
SAN DIEGO, April 26, 2023 /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 first quarter ended March 31, 2023, and provided an update on its clinical pipeline and other corporate developments.
Highlights from the Quarter Ended March 31, 2023, and Other Recent Events:
"The first quarter of 2023 was an exceptional period for Viking," stated Brian Lian, Ph.D., chief executive officer of Viking. "Early in the quarter, we announced completion of enrollment in the Phase 2b VOYAGE study of our lead thyroid hormone receptor beta agonist VK2809 in patients with NASH and fibrosis, and we expect to report data for the primary endpoint of this study in the second quarter. Later in the quarter, we announced results from the first Phase 1 study of our dual incretin receptor agonist VK2735, demonstrating encouraging safety and tolerability, along with positive signs of clinical efficacy, and we expect to initiate a Phase 2 trial in patients with obesity around mid-year. In conjunction with the announcement of Phase 1 results for VK2735, we announced the initiation of a Phase 1 trial to evaluate an oral formulation of this important compound, and we continue to explore further expansion of our weight loss platform. Finally, at the end of the quarter we completed a successful public offering of common stock, strengthening our balance sheet and providing the resources to support the company through multiple clinical catalysts over the coming quarters."
Pipeline and Corporate Highlights
First Quarter 2023 Financial Highlights
Research and development expenses for the three months ended March 31, 2023 were $11.0 million compared to $12.6 million for the same period in 2022. The decrease was primarily due to decreased expenses related to clinical studies, pre-clinical studies and third-party consultants, partially offset by increased expenses related to salaries and benefits, stock-based compensation and regulatory service costs.
General and administrative expenses for the three months ended March 31, 2023 were $9.5 million compared to $3.7 million for the same period in 2022. The increase was primarily due to increased expenses related to legal and patent services, stock-based compensation and salaries and benefits.
For the three months ended March 31, 2023, Viking reported a net loss of $19.5 million, or $0.25 per share, compared to a net loss of $16.1 million, or $0.21 per share, in the corresponding period in 2022. The increase in net loss and net loss per share for the three months ended March 31, 2023 was primarily due to the increase in general and administrative expenses, noted previously, partially offset by increased interest income compared to the same period of 2022.
Balance Sheet as of March 31, 2023
At March 31, 2023, Viking held cash, cash equivalents and short-term investments of $135.7 million, compared to $155.5 million as of December 31, 2022.
Conference Call
Management will host a conference call to discuss the company's first quarter 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 3, 2023 by dialing (877) 344-7529 from the U.S. or (412) 317-0088 from outside the U.S. and entering conference ID # 1110653. 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, with three compounds currently in clinical trials. 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. Data from a Phase 1 trial evaluating VK2735 (dosed subcutaneously) for metabolic disorders demonstrated an encouraging safety and tolerability profile as well as positive signs of clinical benefit. The company also recently initiated a Phase 1 study to evaluate an oral formulation of VK2735. 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 and cash resources. 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, 2022, 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. Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except per share amounts) (Unaudited) | ||||||||
Three Months Ended | ||||||||
2023 | 2022 | |||||||
Revenues | $ | - | $ | - | ||||
Operating expenses: | ||||||||
Research and development | 11,008 | 12,555 | ||||||
General and administrative | 9,529 | 3,690 | ||||||
Total operating expenses | 20,537 | 16,245 | ||||||
Loss from operations | (20,537) | (16,245) | ||||||
Other income (expense): | ||||||||
Amortization of financing costs | (28) | (12) | ||||||
Interest income, net | 1,034 | 154 | ||||||
Total other income, net | 1,006 | 142 | ||||||
Net loss | (19,531) | (16,103) | ||||||
Other comprehensive loss, net of tax: | ||||||||
Unrealized gain (loss) on securities | 501 | (893) | ||||||
Foreign currency translation gain (loss) | (17) | 31 | ||||||
Comprehensive loss | $ | (19,047) | $ | (16,965) | ||||
Basic and diluted net loss per share | $ | (0.25) | $ | (0.21) | ||||
Weighted-average shares used to compute basic | 78,352 | 77,413 |
Viking Therapeutics, Inc. Consolidated Balance Sheets
(In thousands, except share and per share amounts) | ||||||||
March 31, | December 31, | |||||||
(Unaudited) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 18,362 | $ | 36,632 | ||||
Short-term investments – available for sale | 117,302 | 118,853 | ||||||
Prepaid clinical trial and preclinical study costs | 9,878 | 8,144 | ||||||
Prepaid expenses and other current assets | 3,926 | 3,411 | ||||||
Total current assets | 149,468 | 167,040 | ||||||
Right-of-use assets | 1,346 | 1,418 | ||||||
Deferred financing costs | 48 | 38 | ||||||
Deposits | 33 | 33 | ||||||
Total assets | $ | 150,895 | $ | 168,529 | ||||
Liabilities and stockholders' equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 3,799 | $ | 8,529 | ||||
Other accrued liabilities | 11,541 | 13,114 | ||||||
Lease liability, current | 309 | 304 | ||||||
Total current liabilities | 15,649 | 21,947 | ||||||
Lease liability, net of current portion | 1,181 | 1,260 | ||||||
Total long-term liabilities | 1,181 | 1,260 | ||||||
Total liabilities | 16,830 | 23,207 | ||||||
Commitments and contingencies (Note 8) | ||||||||
Stockholders' equity: | ||||||||
Preferred stock, $0.00001 par value: 10,000,000 shares authorized at | - | - | ||||||
Common stock, $0.00001 par value: 300,000,000 shares authorized at | 1 | 1 | ||||||
Treasury stock at cost, 2,193,251 shares at March 31, 2023 and December 31, 2022 | (6,795) | (6,795) | ||||||
Additional paid-in capital | 453,057 | 445,267 | ||||||
Accumulated deficit | (311,580) | (292,049) | ||||||
Accumulated other comprehensive loss | (618) | (1,102) | ||||||
Total stockholders' equity | 134,065 | 145,322 | ||||||
Total liabilities and stockholders' equity | $ | 150,895 | $ | 168,529 |
Last Trade: | US$65.87 |
Daily Change: | 1.24 1.92 |
Daily Volume: | 5,928,600 |
Market Cap: | US$7.300B |
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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, with three compounds currently in clinical trials. Viking’s research and development activities leverage...
CLICK TO LEARN MOREViking 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, with three compounds currently in clinical trials. Viking’s research and development activities leverage...
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