Full Press Release Details
SAN DIEGO, March 21, 2017 -- 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, 2016, and provided an update on its clinical pipeline and other corporate developments.
Highlights from, and Subsequent to, the Quarter Ended December 31, 2016
"We made excellent progress with multiple pipeline programs in 2016. We continued enrolling patients into the Phase 2 trial of our selective androgen receptor modulator VK5211 for hip fracture, initiated a Phase 2 trial with our novel thyroid receptor beta agonist VK2809 in fatty liver disease and hypercholesterolemia, began planning for a proof-of-concept trial with VK2809 in GSD Ia, a new orphan indication, and reported positive proof-of-concept data from our second thyroid receptor agonist, VK0214, in an in vivo model of the orphan disease X-linked adrenoleukodystrophy. We expect this momentum to continue in 2017 as we plan to announce the results from the hip fracture study mid-year, followed later in the year by the results from the fatty liver and hypercholesterolemia trial. Each of these events will mark a key milestone for the company, providing clinical data in indications that each represent significant potential revenue opportunities," stated Brian Lian, Ph.D., chief executive officer of Viking. "We are also continuing our strategic partnerships with the Kennedy Krieger Institute and Duke University, which together provide valuable support as we work to advance our two orphan programs into clinical development. We believe VK2809 in GSD Ia and VK0214 in X-ALD each represent important opportunities to apply our novel science to areas of high unmet medical need. Finally, we were able to accomplish all of this while maintaining a lean operating model, ending the year with a strong cash position at over $13 million, and retaining access to approximately $14 million in additional funding through our current equity line and ATM program."
Pipeline and Corporate Highlights
Financial Highlights
Quarter Ended December 31, 2016 and 2015
Research and development expenses for the three months ended December 31, 2016 were $2.6 million compared to $3.2 million for the same period in 2015. The decrease was primarily due to decreased activities related to third party manufacturing of our clinical-stage drug candidates.
General and administrative expenses for the three months ended December 31, 2016 were $1.1 million compared to $1.4 million for the same period in 2015. The decrease was primarily due to decreases in stock-based compensation expense.
For the three months ended December 31, 2016, Viking reported a net loss of $3.6 million, or $0.18 per share, compared to a net loss of $5.1 million, or $0.56 per share, in the corresponding period in 2015.
Year Ended December 31, 2016 and 2015
Research and development expenses for the year ended December 31, 2016 were $9.0 million compared to $7.0 million for the same period in 2015. 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.
General and administrative expenses for the year ended December 31, 2016 were $4.8 million compared to $5.0 million for the same period in 2015. The decrease in general and administrative expenses was primarily related to a decrease in stock-based compensation expense, offset by an increase in costs related to being a publicly traded company.
For the year ended December 31, 2016, Viking reported a net loss of $14.7 million, or $0.90 per share, compared to a net loss of $23.4 million, or $3.68 per share, in the comparable period in 2015. The decrease in net loss in the year ended December 31, 2016 was primarily due to a change in fair value of accrued license fees expense of $9.4 million recorded in 2015 with no comparable expense in 2016.
Balance Sheet as of December 31, 2016
At December 31, 2016, Viking held cash, cash equivalents and investments totaling $13.2 million. As of February 28, 2017, Viking had 23,825,425 shares of common stock outstanding.
To participate on the conference call, please dial (877) 870-4263 from the U.S. or (412) 317-0790 from outside the U.S. In addition, following the completion of the call, a telephone replay will be accessible until April 3, 2017 by dialing (877) 344-7529 from the U.S. or (412) 317-0088 from outside the U.S. and entering conference ID #
10102405. 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 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.
Forward-Looking Statements
This press release contains forward-looking statements regarding Viking Therapeutics, including statements about Viking's expectations regarding its development activities, expected timing for clinical trial screening, enrollment and completion and the announcement of clinical trial data, VK5211's, VK2809's and VK0214's potential to produce therapeutic benefits and create significant revenue opportunities for the company, expectations regarding an IND application for VK2809, and Viking's ability to use its equity line and ATM program for raising capital. 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; and risks regarding regulatory requirements, among others discussed in the "Risk Factors" section of our most recent periodic reports filed with the Securities and Exchange Commission (SEC), including our most recent Form 10-K and Form 10-Q, all of which you may obtain for free on the SEC's website at www.sec.gov. 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, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Revenues | $ | - | $ | - | $ | - | $ | - | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 2,647,469 | 3,219,414 | 9,000,499 | 6,966,842 | ||||||||||||
| General and administrative | 1,090,054 | 1,400,889 | 4,846,776 | 5,029,636 | ||||||||||||
| Total operating expenses | 3,737,523 | 4,620,303 | 13,847,275 | 11,996,478 | ||||||||||||
| Loss from operations | (3,737,523 | ) | (4,620,303 | ) | (13,847,275 | ) | (11,996,478 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Change in fair value of accrued license fees | - | - | - | (9,381,848 | ) | |||||||||||
| Change in fair value of debt conversion feature liability | 620,087 | (216,841 | ) | 1,064,170 | (1,043,478 | ) | ||||||||||
| Amortization of debt discount | (431,227 | ) | (240,516 | ) | (1,788,088 | ) | (893,502 | ) | ||||||||
| Amortization of financing costs | (92,849 | ) | - | (138,701 | ) | - | ||||||||||
| Interest expense, net | (3,098 | ) | (13,303 | ) | (21,928 | ) | (88,682 | ) | ||||||||
| Total other income (expense) | 92,913 | (470,660 | ) | (884,547 | ) | (11,407,510 | ) | |||||||||
| Net loss | (3,644,610 | ) | (5,090,963 | ) | (14,731,822 | ) | (23,403,988 | ) | ||||||||
| Other comprehensive loss, net of tax: | ||||||||||||||||
| Unrealized gain (loss) on securities | (755 | ) | (4,848 | ) | 478 | (7,370 | ) | |||||||||
| Comprehensive loss | $ | (3,645,365 | ) | $ | (5,095,811 | ) | $ | (14,731,344 | ) | $ | (23,411,358 | ) | ||||
| Basic and diluted net loss per share | $ | (0.18 | ) | $ | (0.56 | ) | $ | (0.90 | ) | $ | (3.68 | ) | ||||
| Weighted-average shares used to compute basic and diluted net loss per share | 19,930,096 | 9,012,768 | 16,278,292 | 6,355,869 |
Viking Therapeutics, Inc.
| December 31, 2016 (unaudited) | December 31, 2015 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 3,075,502 | $ | 768,550 | ||||
| Short-term investments - available for sale | 10,075,058 | 13,335,499 | ||||||
| Prepaid expenses and other current assets | 824,269 | 1,097,599 | ||||||
| Total current assets | 13,974,829 | 15,201,648 | ||||||
| Deferred public offering and other financing costs | 521,538 | 157,455 | ||||||
| Deposits | 39,341 | 80,000 | ||||||
| Total assets | $ | 14,535,708 | $ | 15,439,103 | ||||
| Liabilities, convertible notes and stockholders' equity (deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,203,888 | $ | 592,414 | ||||
| Other accrued liabilities | 1,237,122 | 1,384,398 | ||||||
| Accrued interest | 34,894 | - | ||||||
| Convertible notes payable, current portion (net of discount of $675,589 and $0 at December 31, 2016 and 2015, respectively) | 3,269,582 | - | ||||||
| Debt conversion feature liability | 731,048 | - | ||||||
| Total current liabilities | 6,476,534 | 1,976,812 | ||||||
| Accrued interest, non-current | - | 183,611 | ||||||
| Convertible notes payable (net of discount of $0 and $348,460 at December 31, 2016 and 2015, respectively) | - | 2,151,540 | ||||||
| Debt conversion feature liability | - | 2,370,903 | ||||||
| Deferred rent | 16,307 | 31,239 | ||||||
| Total long-term liabilities | 16,307 | 4,737,293 | ||||||
| Total liabilities | 6,492,841 | 6,714,105 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.00001 par value: 10,000,000 shares authorized at December 31, 2016 and 2015; no shares issued and outstanding at December 31, 2016 and 2015 | - | - | ||||||
| Common stock, $0.00001 par value: 300,000,000 shares authorized at December 31, 2016 and 2015; 20,823,873 shares issued and outstanding at December 31, 2016 and 9,683,741 shares issued and outstanding at December 31, 2015 | 208 | 97 | ||||||
| Additional paid-in capital | 68,326,818 | 54,277,716 | ||||||
| Accumulated deficit | (60,277,267 | ) | (45,545,445 | ) | ||||
| Accumulated other comprehensive loss | (6,892 | ) | (7,370 | ) | ||||
| Total stockholders' equity | 8,042,867 | 8,724,998 | ||||||
| Total liabilities and stockholders' equity | $ | 14,535,708 | $ | 15,439,103 |
Follow Viking on Twitter @Viking_VKTX.
Vida Strategic Partners
Stephanie Diaz (Investors)