Full Press Release Details
Conference call scheduled for 4:30 p.m. ET today
SAN DIEGO, May 9, 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 first quarter ended March 31, 2018, and provided an update on its clinical pipeline and other corporate developments.
Highlights from, and Subsequent to, the Quarter Ended March 31, 2018
"The first quarter has been an exciting and productive period for Viking as we built upon the momentum from 2017," stated Brian Lian, Ph.D., chief executive officer of Viking Therapeutics. "With our novel selective androgen receptor modulator (SARM) VK5211, for hip fracture, we continued working toward a planned meeting with the FDA on potential next steps for the program. We anticipate that this meeting will occur in the second half of the year. We also continued enrolling patients in the Phase 2 trial of our novel thyroid receptor beta agonist, VK2809 for non-alcoholic fatty liver disease (NAFLD) and hypercholesterolemia, and remain on track to announce data from this study in the second half of the year. Lastly, we continued to advance our rare disease programs targeting glycogen storage disease (GSD) and X-linked adrenoleukodystrophy (X-ALD). We expect to initiate a proof-of-concept trial for VK2809 in GSD Ia this quarter, and we plan to complete IND-enabling studies for VK0214 in X-ALD later this year. Each of these programs represents exciting future opportunities for Viking."
Pipeline and Corporate Highlights
In November 2017, the company announced positive results from a 12-week, Phase 2 clinical trial of VK5211 in patients who recently suffered a hip fracture. 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. 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 present detailed results from this study at a scientific meeting later in the year. The company is currently exploring options for advancing VK5211.
Financial Highlights
Three Months Ended March 31, 2018 and 2017
Research and development expenses for the three months ended March 31, 2018 were $3.0 million compared to $3.5 million for the same period in 2017. The decrease was primarily due to decreased manufacturing expenses for our drug candidates and a decrease in activities related to our VK5211 clinical development program, offset by an increase in certain pre-clinical efforts and an increase in the use of third party consultants.
General and administrative expenses for the three months ended March 31, 2018 were $1.8 million compared to $1.4 million for the same period in 2017. The increase was primarily due to increases in stock based compensation and salaries and benefits-related expenses.
For the three months ended March 31, 2018, Viking reported a net loss of $3.6 million, and a basic net loss per share of $0.08, compared to a net loss of $5.2 million, and a basic net loss per share of $0.23, in the corresponding period in 2017. The decrease in net loss for the three months ended March 31, 2018 was primarily due to the increase in income related to the decrease in fair value of debt conversion feature liability.
Balance Sheet as of March 31, 2018
At March 31, 2018, Viking held cash, cash equivalents and short-term investments totaling $77.5 million. As of April 30, 2018, Viking had 50,933,195 shares of common stock outstanding.
Management will host a conference call to discuss the company's first 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 May 16, 2018 by dialing (877) 344-7529 from the U.S. or (412) 317-0088 from outside the U.S. and entering conference ID # 10118827. 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. The company's clinical programs include VK5211, an orally available, non-steroidal selective androgen receptor modulator (SARM). In a Phase 2 trial in patients recovering from hip fracture, patients who received VK5211 experienced significant improvements in measures of lean body mass compared to patients who received placebo. The company's second clinical program is evaluating VK2809, a small molecule thyroid beta agonist in a Phase 2 trial for the treatment of non-alcoholic fatty liver disease (NAFLD) and hypercholesterolemia. The company is also developing VK0612, a first-in-class, orally available drug candidate in Phase 2 development for type 2 diabetes. Additional programs include 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. Viking holds exclusive worldwide rights to a portfolio of five therapeutic programs in clinical trials or preclinical studies, including those noted above, which are based on small molecules licensed from Ligand Pharmaceuticals Incorporated.
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 development activities, timelines and milestones, as well as the company's goals and plans regarding VK5211, VK2809 and VK0214 and their respective prospects. 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 VK5211 and VK2809; 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, 2017, 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)
| Three Months Ended March 31, | ||||||||
| 2018 | 2017 | |||||||
| Revenues | $ | - | $ | - | ||||
| Operating expenses: | ||||||||
| Research and development | 3,043 | 3,528 | ||||||
| General and administrative | 1,762 | 1,441 | ||||||
| Total operating expenses | 4,805 | 4,969 | ||||||
| Loss from operations | (4,805 | ) | (4,969 | ) | ||||
| Other income (expense): | ||||||||
| Change in fair value of debt conversion feature liability | 1,361 | 278 | ||||||
| Amortization of debt discount | (258 | ) | (431 | ) | ||||
| Amortization of financing costs | (30 | ) | (98 | ) | ||||
| Interest income (expense), net | 181 | (2 | ) | |||||
| Total other income (expense), net | 1,254 | (253 | ) | |||||
| Net loss | (3,551 | ) | (5,222 | ) | ||||
| Other comprehensive loss, net of tax: | ||||||||
| Unrealized loss on securities | (89 | ) | (1 | ) | ||||
| Comprehensive loss | $ | (3,640 | ) | $ | (5,223 | ) | ||
| Net loss per common share | ||||||||
| Basic | $ | (0.08 | ) | $ | (0.23 | ) | ||
| Diluted | $ | (0.10 | ) | $ | (0.23 | ) | ||
| Weighted-average shares used to compute net loss per share | ||||||||
| Basic | 44,649 | 22,353 | ||||||
| Diluted | 45,306 | 22,353 |
Viking Therapeutics, Inc.
(In thousands, except share and per share amounts)
| March 31, 2018 | December 31, 2017 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 36,356 | $ | 8,988 | ||||
| Short-term investments - available for sale | 41,112 | 11,587 | ||||||
| Prepaid clinical trial and preclinical study costs | 1,014 | 887 | ||||||
| Prepaid expenses and other current assets | 249 | 389 | ||||||
| Total current assets | 78,731 | 21,851 | ||||||
| Deferred public offering and other financing costs | 240 | 270 | ||||||
| Total assets | $ | 78,971 | $ | 22,121 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 658 | $ | 1,529 | ||||
| Other accrued liabilities | 1,889 | 2,257 | ||||||
| Accrued interest, current | 34 | 22 | ||||||
| Convertible notes payable, current (net of discount of $146 and $404 at March 31, 2018 and December 31, 2017, respectively) | 3,721 | 3,451 | ||||||
| Debt conversion feature liability, current | 37 | 1,398 | ||||||
| Total current liabilities | 6,339 | 8,657 | ||||||
| Total liabilities | 6,339 | 8,657 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.00001 par value: 10,000,000 shares authorized at March 31, 2018 and December 31, 2017; no shares issued and outstanding at March 31, 2018 and December 31, 2017 | - | - | ||||||
| Common stock, $0.00001 par value: 300,000,000 shares authorized at March 31, 2018 and December 31, 2017; 50,933,195 and 35,817,104 shares issued and outstanding at March 31, 2018 and December 31, 2017, respectively | 1 | - | ||||||
| Additional paid-in capital | 157,146 | 94,339 | ||||||
| Accumulated deficit | (84,406 | ) | (80,855 | ) | ||||
| Accumulated other comprehensive loss | (109 | ) | (20 | ) | ||||
| Total stockholders' equity | 72,632 | 13,464 | ||||||
| Total liabilities and stockholders' equity | $ | 78,971 | $ | 22,121 |
Vida Strategic Partners
Stephanie Diaz (Investors)