Full Press Release Details
Viking Therapeutics Reports Third Quarter 2015 Financial Results and Provides Corporate Update
SAN DIEGO, CA - November 5, 2015 - Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders, today announced financial results for the third quarter of 2015 and provided an update on its clinical pipeline and other corporate developments.
Highlights from, and Subsequent to, the Quarter Ended September 30, 2015
"We are excited about the rapid progress we have made with our clinical pipeline, highlighted by VK5211, our novel small molecule selective androgen receptor modulator (SARM) in development for patients recovering from hip fracture," said Brian Lian, Ph.D., president and chief executive officer of Viking. "In a short amount of time, we successfully completed a safety, tolerability and pharmacokinetic study in healthy elderly subjects. Following that, we initiated a Phase 2 trial designed to evaluate VK5211 in the hip fracture setting. We believe that VK5211 may stimulate the formation of new bone and muscle, which may benefit patients recovering from hip fracture surgery, a population that frequently experiences accelerated losses of bone and muscle. In addition to VK5211, we continue working to advance our novel thyroid beta agonist, VK2809, into a Phase 2 trial in patients with hypercholesterolemia and fatty liver disease. We plan to initiate this trial by the end of 2015 and expect both Phase 2 trials to be completed in 2016. Overall, we continue to execute according to our operational and financial plans."
Pipeline and Corporate Highlights
Financial Highlights
Third Quarter Ended September 30, 2015
Research and development expenses for the three months ended September 30, 2015 were $2.5 million compared to $0.8 million for the same period in 2014. The increase was primarily due to increased activities related to the planned initiation of Phase 2 clinical trials for VK5211 and VK2809.
General and administrative expenses for the three months ended September 30, 2015 increased to $1.8 million compared to $0.4 million for the same period in 2014. The increase was primarily due to increased staffing and other costs associated with being a publicly traded company following the close of the company's initial public offering in May 2015.
For the three months ended September 30, 2015, Viking reported a net loss of $4.7 million, or $0.53 per share, compared to a net loss of $0.3 million, or $0.06 per share, in the corresponding period in 2014. The increase in net loss and net loss per share in the three months ended September 30, 2015 was primarily due to increased research and development and general and administrative expenses following the close of the company's initial public offering.
Nine Months Ending September 30, 2015
Research and development expenses for the nine months ended September 30, 2015 were $3.7 million compared to $22.1 million for the same period in 2014. The decrease in research and development expenses was primarily related to the company recording a one-time $21.7 million license fee liability as research and development expense during the nine months ended September 30, 2014. The decrease in research and development expenses during the nine months ended September 30, 2015 were partially offset by increases in the costs of manufacturing and clinical activities associated with advancing the company's drug candidates and increases in personnel-related costs, including non-cash stock-based compensation.
General and administrative expenses for the nine months ended September 30, 2015 increased to $3.6 million compared to $1.0 million for the same period in 2014. The increase in general and administrative expenses was due to increased staffing and other costs of being a publicly traded company following the close of the company's initial public offering and additional non-cash stock-based compensation expense.
For the nine months ended September 30, 2015, Viking reported a net loss of $18.3 million, or $2.69 per share, compared to a net loss of $23.3 million, or $5.84 per share, in the comparable period in 2014. The decrease in net loss and net loss per share in the nine months ended September 30, 2015 was primarily due to not having the one-time license fee liability charge in the nine months ended September 30, 2015, which was recorded in the corresponding period in 2014 as well as additional shares outstanding following the close of the company's initial public offering in May. The decrease was partially offset by an increase in the expense associated with the fair value of accrued license fees.
Balance Sheet as of September 30, 2015
At September 30, 2015, Viking had cash, cash equivalents and investments totalling $17.5 million. As of November 5, 2015, Viking had 9,678,312 shares of common stock outstanding.
More detailed financial information and analysis may be found in Viking's Quarterly Report on Form 10-Q, which will be filed on or about November 5, 2015 with the Securities and Exchange Commission.
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 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 entering 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 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 the company's development activities, timelines and milestones, VK5211's Phase 2 clinical trial, expected timing for completing the VK5211 clinical trial, VK5211's potential to produce therapeutic benefits, the timing for initiating and completing the proposed Phase 2 clinical trial and the submission of an investigational new drug (IND) application for VK2809, as well as VK2809's potential to produce therapeutic benefits. 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. 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 September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| Revenues | $ | - | $ | - | $ | - | $ | - | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 2,507,553 | 788,646 | 3,747,428 | 22,080,286 | ||||||||||||
| General and administrative | 1,780,668 | 360,403 | 3,628,747 | 1,034,132 | ||||||||||||
| Total operating expenses | 4,288,221 | 1,149,049 | 7,376,175 | 23,114,418 | ||||||||||||
| Loss from operations | (4,288,221 | ) | (1,149,049 | ) | (7,376,175 | ) | (23,114,418 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Change in fair value of accrued license fees | - | 695,251 | (9,381,848 | ) | (264,112 | ) | ||||||||||
| Change in fair value of debt conversion feature liability | (197,496 | ) | 413,703 | (826,637 | ) | 405,782 | ||||||||||
| Amortization of debt discount | (240,515 | ) | (196,669 | ) | (652,986 | ) | (263,651 | ) | ||||||||
| Interest expense, net | (10,312 | ) | (25,037 | ) | (75,379 | ) | (37,131 | ) | ||||||||
| Total other income (expense) | (448,323 | ) | 887,248 | (10,936,850 | ) | (159,112 | ) | |||||||||
| Net loss | (4,736,544 | ) | (261,801 | ) | (18,313,025 | ) | (23,273,530 | ) | ||||||||
| Other comprehensive loss, net of tax: | ||||||||||||||||
| Unrealized gain (loss) on securities | 7,613 | - | (4,848 | ) | - | |||||||||||
| Comprehensive loss | $ | (4,728,931 | ) | $ | (261,801 | ) | $ | (18,317,873 | ) | $ | (23,273,530 | ) | ||||
| Basic and diluted net loss per share | $ | (0.53 | ) | $ | (0.06 | ) | $ | (2.69 | ) | $ | (5.84 | ) | ||||
| Weighted-average shares used to compute basic and diluted net loss per share | 8,947,480 | 4,518,439 | 6,802,169 | 3,982,147 |
Viking Therapeutics, Inc.
| September 30, 2015 | December 31, 2014 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 2,140,115 | $ | 755,857 | ||||
| Short-term investments - available for sale | 15,349,507 | - | ||||||
| Prepaid expenses and other current assets | 1,442,629 | 17,827 | ||||||
| Total current assets | 18,932,251 | 773,684 | ||||||
| Deferred IPO financing costs | - | 2,268,675 | ||||||
| Other assets | 80,000 | 775 | ||||||
| Total assets | $ | 19,012,251 | $ | 3,043,134 | ||||
| Liabilities, convertible notes and stockholders' equity (deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 401,672 | $ | 1,830,724 | ||||
| Accrued license fees | - | 19,865,863 | ||||||
| Other accrued liabilities | 1,103,432 | 380,257 | ||||||
| Accrued interest | 152,361 | 77,222 | ||||||
| Convertible notes payable, current portion (net of discount of $588,976 and $6,076 at September 30, 2015 and December 31, 2014, respectively) | 1,911,024 | 304,274 | ||||||
| Debt conversion feature liability | 2,154,062 | 58,742 | ||||||
| Total current liabilities | 5,722,551 | 22,517,082 | ||||||
| Convertible notes payable (net of discount of $0 and $1,235,886 at September 30, 2015 and December 31, 2014, respectively) | - | 1,264,114 | ||||||
| Debt conversion feature liability | - | 1,390,469 | ||||||
| Deferred rent | 19,149 | - | ||||||
| Total long-term liabilities | 19,149 | 2,654,583 | ||||||
| Total liabilities | 5,741,700 | 25,171,665 | ||||||
| Commitments and contingencies ( Note 7 ) | ||||||||
| Stockholders' equity (deficit): | ||||||||
| Common stock, $0.00001 par value: 300,000,000 shares authorized at September 30, 2015 and 25,000,000 shares authorized at December 31, 2014; 9,783,312 shares issued and outstanding at September 30, 2015 and 6,000,000 shares issued and outstanding at December 31, 2014 | 98 | 60 | ||||||
| Additional paid-in capital | 53,729,783 | 12,866 | ||||||
| Accumulated deficit | (40,454,482 | ) | (22,141,457 | ) | ||||
| Accumulated other comprehensive loss | (4,848 | ) | - | |||||
| Total stockholders' equity (deficit) | 13,270,551 | (22,128,531 | ) | |||||
| Total liabilities and stockholders' equity (deficit) | $ | 19,012,251 | $ | 3,043,134 |
Viking Therapeutics, Inc.
Brian Lian, President and CEO
Vida Strategic Partners
Stephanie Diaz (Investors)