Conference call scheduled for 4:30 p.m. ET today
SAN DIEGO, Feb. 8, 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 fourth quarter and year ended December 31, 2022, and provided an update on its clinical pipeline and other corporate developments.
Highlights from the Quarter Ended December 31, 2022, and Other Recent Events:
"Our progress throughout 2022 has positioned Viking for an exciting year in 2023, and we expect to report data from all three of our active clinical programs this year," 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 have completed enrollment in our Phase 2b VOYAGE trial, and we expect to report initial data, including the trial's primary endpoint, in the second quarter of 2023. The Phase 1 study evaluating our dual-agonist compound, VK2735, continues to progress and we expect to report the initial data from this study later this quarter. Finally, our Phase 1b trial evaluating VK0214 in X-ALD patients continues to enroll and we expect to report data from this trial later this year. Importantly, we are starting the year with a strong cash position of approximately $155 million, providing an operating runway that extends beyond the key milestones for our clinical programs."
Pipeline and Corporate Highlights
Fourth Quarter and Full-Year 2022 Financial Highlights
Fourth Quarter Ended December 31, 2022 and 2021
Research and development expenses for the three months ended December 31, 2022 were $16.2 million compared to $9.8 million for the same period in 2021. The increase was primarily due to increased expenses related to pre-clinical studies, manufacturing for the company's drug candidates, clinical studies, stock-based compensation, and salaries and benefits, partially offset by decreased expenses related to third-party consultants.
General and administrative expenses for the three months ended December 31, 2022 were $4.1 million compared to $2.7 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, partially offset by decreased expenses related to third-party consultants.
For the three months ended December 31, 2022, Viking reported a net loss of $19.6 million, or $0.26 per share, compared to a net loss of $12.4 million, or $0.16 per share, in the corresponding period in 2021. The increase in net loss and net loss per share for the three months ended December 31, 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.
Twelve Months Ended December 31, 2022 and 2021
Research and development expenses for the year ended December 31, 2022 were $54.2 million compared to $45.0 million for the same period in 2021. The increase was primarily due to increased expenses related to manufacturing for the company's drug candidates, pre-clinical studies, salaries and benefits and stock-based compensation, partially offset by decreased expenses related to third-party consultants and clinical studies.
General and administrative expenses for the year ended December 31, 2022 were $16.1 million compared to $10.7 million for the same period in 2021. The increase was primarily due to increased expenses related to legal services, stock-based compensation, salaries and benefits and insurance, partially offset by decreased expenses related to professional fees and third-party consultants.
For the year ended December 31, 2022, Viking reported a net loss of $68.9 million, or $0.90 per share, compared to a net loss of $55.0 million, or $0.71 per share, in the corresponding period in 2021. The increase in net loss and net loss per share for the year ended December 31, 2022 was primarily due to the increase in research and development expenses and general and administrative expenses, noted previously.
Balance Sheet as of December 31, 2022
At December 31, 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 fourth quarter and full-year 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 February 15, 2023 by dialing (877) 344-7529 from the U.S. or (412) 317-0088 from outside the U.S. and entering conference ID # 8094886. 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. 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 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. Statements of Operations and Comprehensive Loss (In thousands, except per share amounts) (Unaudited) | |||||||||||||||
Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
Revenues | $ | — | $ | — | $ | — | $ | — | |||||||
Operating expenses: | |||||||||||||||
Research and development | 16,178 | 9,847 | 54,234 | 44,981 | |||||||||||
General and administrative | 4,105 | 2,663 | 16,121 | 10,701 | |||||||||||
Total operating expenses | 20,283 | 12,510 | 70,355 | 55,682 | |||||||||||
Loss from operations | (20,283) | (12,510) | (70,355) | (55,682) | |||||||||||
Other income (expense): | |||||||||||||||
Amortization of financing costs | (8) | (12) | (59) | (18) | |||||||||||
Interest income, net | 732 | 159 | 1,589 | 703 | |||||||||||
Realized loss on investments, net | — | — | (42) | — | |||||||||||
Foreign exchange gain | — | 7 | — | 7 | |||||||||||
Total other income, net | 724 | 154 | 1,488 | 692 | |||||||||||
Net loss | (19,559) | (12,356) | (68,867) | (54,990) | |||||||||||
Other comprehensive gain (loss), net of tax: | |||||||||||||||
Unrealized gain (loss) on securities | 518 | (379) | (295) | (495) | |||||||||||
Foreign currency translation gain (loss) | 141 | — | (258) | — | |||||||||||
Comprehensive loss | $ | (18,900) | $ | (12,735) | $ | (69,420) | $ | (55,485) | |||||||
Basic and diluted net loss per common share | $ | (0.26) | $ | (0.16) | $ | (0.90) | $ | (0.71) | |||||||
Weighted-average shares used to compute basic and | 76,587 | 78,058 | 76,834 | 77,198 |
Viking Therapeutics, Inc. Balance Sheets (In thousands, except share and per share amounts) | |||||||
December 31, 2022 | December 31, 2021 | ||||||
(Unaudited) | |||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 36,632 | $ | 26,371 | |||
Short-term investments – available for sale | 118,853 | 175,732 | |||||
Prepaid clinical trial and preclinical study costs | 8,144 | 7,806 | |||||
Prepaid expenses and other current assets | 3,411 | 619 | |||||
Total current assets | 167,040 | 210,528 | |||||
Right-of-use assets | 1,418 | 25 | |||||
Deferred financing costs | 38 | 76 | |||||
Deposits | 33 | 33 | |||||
Total assets | $ | 168,529 | $ | 210,662 | |||
Liabilities and stockholders' equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 8,529 | $ | 1,444 | |||
Other accrued liabilities | 13,114 | 7,305 | |||||
Lease liability, current | 304 | 29 | |||||
Total current liabilities | 21,947 | 8,778 | |||||
Lease liability, net of current portion | 1,260 | — | |||||
Total long-term liabilities | 1,260 | — | |||||
Total liabilities | 23,207 | 8,778 | |||||
Commitments and contingencies | |||||||
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 | |||||
Additional paid-in capital | 445,267 | 425,614 | |||||
Accumulated deficit | (292,049) | (223,182) | |||||
Accumulated other comprehensive loss | (1,102) | (549) | |||||
Treasury stock at cost, 2,193,251 shares at December 31, 2022, no shares | (6,795) | — | |||||
Total stockholders' equity | 145,322 | 201,884 | |||||
Total liabilities and stockholders' equity | $ | 168,529 | $ | 210,662 |
Last Trade: | US$54.51 |
Daily Change: | 1.09 2.04 |
Daily Volume: | 2,524,565 |
Market Cap: | US$6.040B |
November 19, 2024 November 12, 2024 November 04, 2024 October 31, 2024 October 28, 2024 |
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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