Full Press Release Details
Conference call scheduled for 4:30 p.m. ET today
SAN DIEGO, March 7, 2018 -- 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, 2017, and provided an update on its clinical pipeline and other corporate developments.
Highlights from, and Subsequent to, the Quarter Ended December 31, 2017
"The last year has been transformative for Viking as we announced positive clinical data for our lead program, VK5211 for hip fracture, advanced our Phase 2 clinical trial evaluating VK2809 for liver disease, and achieved multiple milestones with our earlier-stage programs targeting glycogen storage disease type Ia (GSD Ia) and X-linked adrenoleukodystrophy (X-ALD)," stated Brian Lian, Ph.D., chief executive officer of Viking. "To support our continued progress, in February 2018 we raised an additional $63 million in gross proceeds, providing resources to support multiple programs through key inflection points. Our recent financings have also strengthened Viking's shareholder base through the addition of multiple fundamental, long-term life science investors, and we appreciate their support. Looking to the balance of 2018, we plan to submit the detailed results from the VK5211 study for presentation at a scientific conference, initiate a proof-of-concept study of VK2809 in GSD Ia, announce top-line data from our ongoing Phase 2 study of VK2809 in fatty liver disease and hypercholesterolemia, and file an investigational new drug (IND) application for VK0214 in X-ALD. Each of these events represents an exciting potential milestone for the company."
Pipeline and Corporate Highlights
Top-line data showed that the Phase 2 trial achieved its primary endpoint, demonstrating statistically significant, dose dependent increases in lean body mass, less head, following treatment with VK5211 as compared to placebo. The study also achieved important secondary endpoints, demonstrating statistically significant increases in appendicular lean body mass and total lean body mass for all doses of VK5211, compared to placebo. While not powered for significance, patients receiving VK5211 demonstrated numerical improvements in certain exploratory assessments of functional performance, including the 6-minute walk test and short physical performance battery, compared with placebo. In addition, VK5211 demonstrated encouraging safety and tolerability in this study, with no drug-related serious adverse events (SAEs) reported. Viking plans to meet with the appropriate regulatory agencies in the second half of 2018 to discuss next steps for this program and is evaluating options for advancing VK5211, including partnering.
Financial Highlights
Fourth Quarter Ended December 31, 2017 and 2016
Research and development expenses for the three months ended December 31, 2017 were $3.0 million compared to $2.6 million for the same period in 2016. The increase was primarily due to increased activities related to our VK2809 clinical development program.
General and administrative expenses for the three months ended December 31, 2017 were $1.4 million compared to $1.1 million for the same period in 2016. The increase was primarily due to increases in salaries and benefits-related expense.
For the three months ended December 31, 2017, Viking reported a net loss of $4.1 million, or $0.14 per share, compared to a net loss of $3.6 million, or $0.18 per share, in the corresponding period in 2016. The increase in net loss for the three months ended December 31, 2017 was primarily due to the increase in research and development expenses and general and administrative expenses noted previously.
Twelve Months Ended December 31, 2017 and 2016
Research and development expenses for the twelve months ended December 31, 2017 were $13.7 million compared to $9.0 million for the same period in 2016. The increase in research and development expenses was primarily related to increases in expenses related to clinical trial activity for our VK5211 and VK2809 programs and preclinical efforts for our VK0214 program, third party manufacturing of our clinical-stage drug candidates, as well as regulatory and other consulting services provided by certain third-party consultants.
General and administrative expenses for the twelve months ended December 31, 2017 were $5.3 million compared to $4.8 million for the same period in 2016. This increase was
primarily due to increases in salaries and benefits-related expense, offset by a decrease in non-cash stock compensation expense.
For the twelve months ended December 31, 2017, Viking reported a net loss of $20.6 million, or $0.79 per share, compared to a net loss of $14.7 million, or $0.90 per share, in the comparable period in 2016. The increase in net loss for the twelve months ended December 31, 2017 was primarily due to the increase in research and development expenses and general and administrative expenses noted previously as well as a decrease in the change in fair value of debt conversation feature liability.
Balance Sheet as of December 31, 2017
At December 31, 2017, Viking held cash, cash equivalents and investments totaling $20.6 million. In February 2018, Viking sold an aggregate of 12,650,000 shares of its common stock resulting in gross proceeds of $63.3 million before deducting underwriting discounts and commissions and other offering expenses. As of February 28, 2018, Viking had 50,898,802 shares of common stock outstanding.
Management will host a conference call to discuss the company's fourth quarter financial results today at 4:30 pm Eastern time. 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 14, 2018 by dialing (877) 344-7529 from the U.S. or (412) 317-0088 from outside the U.S. and entering conference ID #10117261. 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, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders. The company's research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients' lives. Viking has exclusive worldwide rights to a portfolio of five therapeutic programs in clinical trials or preclinical studies, which are based on small molecules licensed from Ligand Pharmaceuticals Incorporated. The company's clinical programs include VK5211, an orally available, non-steroidal selective androgen receptor modulator, or SARM, in Phase 2 development for the treatment and prevention of lean body mass loss in patients who have undergone hip fracture surgery, VK2809, a small molecule thyroid beta agonist in Phase 2 development for hypercholesterolemia and non-alcoholic fatty liver disease, and VK0612, a first-in-class, orally available drug candidate in Phase 2 development for type 2 diabetes. Viking is also developing novel and selective agonists of the thyroid beta receptor for GSD Ia and X-linked adrenoleukodystrophy, as well as two earlier-stage programs targeting metabolic diseases and anemia.
Follow Viking on Twitter @Viking_VKTX.
Forward-Looking Statements
This press release contains forward-looking statements regarding Viking Therapeutics, including statements about Viking's expectations regarding its development activities, timelines and milestones, as well as the company's goals and plans regarding VK5211, VK2809 and VK0214 and their respective prospects, and potential future sales of shares under the company's stock purchase agreements. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially 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 VK5211 and VK2809; risks that prior clinical and preclinical results may not be replicated; and risks regarding regulatory requirements, among others. These forward-looking statements speak only as of the date hereof. Viking disclaims any obligation to update these forward-looking statements.
Viking Therapeutics, Inc.
Statements of Operations and Comprehensive Loss
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Revenues | $ | - | $ | - | $ | - | $ | - | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 3,033,018 | 2,647,469 | 13,741,186 | 9,000,499 | ||||||||||||
| General and administrative | 1,394,235 | 1,090,054 | 5,329,003 | 4,846,776 | ||||||||||||
| Total operating expenses | 4,427,253 | 3,737,523 | 19,070,189 | 13,847,275 | ||||||||||||
| Loss from operations | (4,427,253 | ) | (3,737,523 | ) | (19,070,189 | ) | (13,847,275 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Change in fair value of debt conversion feature liability | 632,628 | 620,087 | 344,928 | 1,064,170 | ||||||||||||
| Amortization of debt discount | (258,152 | ) | (431,227 | ) | (1,282,631 | ) | (1,788,088 | ) | ||||||||
| Amortization of financing costs | (33,516 | ) | (92,849 | ) | (571,044 | ) | (138,701 | ) | ||||||||
| Interest income (expense), net | 1,820 | (3,098 | ) | 1,271 | (21,928 | ) | ||||||||||
| Total other income (expense) | 342,780 | 92,913 | (1,507,476 | ) | (884,547 | ) | ||||||||||
| Net loss | (4,084,473 | ) | (3,644,610 | ) | (20,577,665 | ) | (14,731,822 | ) | ||||||||
| Other comprehensive loss, net of tax: | ||||||||||||||||
| Unrealized gain (loss) on securities | (16,212 | ) | (755 | ) | (12,877 | ) | 478 | |||||||||
| Comprehensive loss | $ | (4,100,685 | ) | $ | (3,645,365 | ) | $ | (20,590,542 | ) | $ | (14,731,344 | ) | ||||
| Basic and diluted net loss per share | $ | (0.14 | ) | $ | (0.18 | ) | $ | (0.79 | ) | $ | (0.90 | ) | ||||
| Weighted-average shares used to compute basic and diluted net loss per share | 29,871,781 | 19,930,096 | 25,978,098 | 16,278,292 |
Viking Therapeutics, Inc.
| December 31, 2017 (unaudited) | December 31, 2016 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 8,988,478 | $ | 3,075,502 | ||||
| Short-term investments - available for sale | 11,587,478 | 10,075,058 | ||||||
| Prepaid clinical trial costs | 886,873 | 541,603 | ||||||
| Prepaid expenses and other current assets | 388,969 | 282,666 | ||||||
| Total current assets | 21,851,798 | 13,974,829 | ||||||
| Deferred public offering and other financing costs | 269,613 | 521,538 | ||||||
| Deposits | - | 39,341 | ||||||
| Total assets | $ | 22,121,411 | $ | 14,535,708 | ||||
| Liabilities, convertible notes and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,529,935 | $ | 1,203,888 | ||||
| Other accrued liabilities | 2,256,543 | 1,237,122 | ||||||
| Accrued interest | 21,960 | 34,894 | ||||||
| Convertible notes payable, current portion (net of discount of $404,437 and $675,589 at December 31, 2017 and 2016, respectively) | 3,450,540 | 3,269,582 | ||||||
| Debt conversion feature liability | 1,397,597 | 731,048 | ||||||
| Total current liabilities | 8,656,575 | 6,476,534 | ||||||
| Deferred rent | - | 16,307 | ||||||
| Total long-term liabilities | - | 16,307 | ||||||
| Total liabilities | 8,656,575 | 6,492,841 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.00001 par value: 10,000,000 shares authorized at December 31, 2017 and 2016; no shares issued and outstanding at December 31, 2017 and 2016 | - | - | ||||||
| Common stock, $0.00001 par value: 300,000,000 shares authorized at December 31, 2017 and 2016; 35,817,104 shares issued and outstanding at December 31, 2017 and 20,823,873 shares issued and outstanding at December 31, 2016 | 358 | 208 | ||||||
| Additional paid-in capital | 94,339,179 | 68,326,818 | ||||||
| Accumulated deficit | (80,854,932 | ) | (60,277,267 | ) | ||||
| Accumulated other comprehensive loss | (19,769 | ) | (6,892 | ) | ||||
| Total stockholders' equity | 13,464,836 | 8,042,867 | ||||||
| Total liabilities and stockholders' equity | $ | 22,121,411 | $ | 14,535,708 |
Follow Viking on Twitter @Viking_VKTX.
Vida Strategic Partners
Stephanie Diaz (Investors)