PR Newswire
SAN DIEGO, Nov. 10, 2016
SAN DIEGO, Nov. 10, 2016 /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 third quarter of 2016, and provided an update on its clinical pipeline and other corporate developments.
Highlights from, and Subsequent to, the Quarter Ended September 30, 2016
"The third quarter was an exciting and productive period at Viking. We continued to advance our lead Phase 2 clinical program, VK5211 for hip fracture, and have now opened 30 international sites to enrollment," stated Brian Lian, Ph.D., chief executive officer of Viking. "We also initiated our Phase 2 trial of VK2809 in patients with hypercholesterolemia and fatty liver disease, and have opened more than half of our planned 30 clinical sites. As we look ahead, we currently expect to have read outs from each study in the first half of next year. We also made important progress with our third program, VK0214, for X-linked adrenoleukodystrophy, and recently reported positive in vivo proof-of-concept data at a prestigious international conference. On the corporate side, we ended the quarter with more than $14 million in cash and entered into an agreement providing access to up to an additional $12 million in capital on attractive terms. This provides the company with stability and flexibility as we approach our important 2017 milestones."
Pipeline and Corporate Highlights
Upcoming Data Presentation from Pipeline Programs
Financial Highlights
Third Quarter Ended September 30, 2016 and 2015
Research and development expenses for the three months ended September 30, 2016 were $2.1 million compared to $2.5 million for the same period in 2015. The decrease was primarily due to decreased clinical manufacturing for our drug candidates offset by an increase in activities related to our ongoing VK5211 Phase 2 clinical trial and commencement of our VK2809 Phase 2 clinical trial.
General and administrative expenses for the three months ended September 30, 2016 decreased to $1.2 million from $1.8 million for the same period in 2015. The decrease was primarily due to a decrease in payroll and stock-based compensation related expenses.
For the three months ended September 30, 2016, Viking reported a net loss of $3.8 million, or $0.20 per share, compared to a net loss of $4.7 million, or $0.53 per share, in the corresponding period in 2015. The decrease in net loss for the three months ended September 30, 2016 was primarily due to the decreases in general and administrative expenses and research and development expenses noted above.
Nine Months Ended September 30, 2016 and 2015
Research and development expenses for the nine months ended September 30, 2016 were $6.4 million compared to $3.7 million for the same period in 2015. The increase was primarily due to increased activities related to our ongoing VK5211 Phase 2 clinical trial and commencement of our VK2809 Phase 2 clinical trial.
General and administrative expenses for the nine months ended September 30, 2016 increased to $3.8 million compared to $3.6 million for the same period in 2015. The increase was primarily due to increased costs associated with being a publicly traded company following the close of the company's initial public offering in May 2015.
For the nine months ended September 30, 2016, Viking reported a net loss of $11.1 million, or $0.74 per share, compared to a net loss of $18.3 million, or $2.69 per share, in the corresponding period in 2015. The decrease in net loss for the nine months ended September 30, 2016 was primarily due to the change in fair value of accrued license fees expense of $9.4 million in 2015 with no comparable expense in 2016, offset by the increase in research and development and general and administrative expenses noted above.
Balance Sheet as of September 30, 2016
At September 30, 2016, Viking held cash, cash equivalents and investments totaling $14.6 million. As of October 31, 2016, Viking had 20,170,264 shares of common stock outstanding.
Conference Call
Viking will host a conference call to discuss financial results and general corporate updates beginning at 4:30 p.m. Eastern Time on Thursday, November 10, 2016. To participate, 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 November 17, 2016 by dialing (877) 344-7529 from the U.S. or (412) 317-0088 from outside the U.S., and entering conference ID # 10094986. 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 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 Viking's ability to use its equity line with Aspire 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 | ||||||||||||||||
(Unaudited) | ||||||||||||||||
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| | Three Months Ended September 30, | | | Nine Months Ended September 30, | | ||||||||||
| | 2016 | | | 2015 | | | 2016 | | | 2015 | | ||||
Revenues | | $ | — | | | $ | — | | | $ | — | | | $ | — | |
Operating expenses: | | | | | | | | | | | | | | | | |
Research and development | | | 2,104,794 | | | | 2,507,553 | | | | 6,353,030 | | | | 3,747,428 | |
General and administrative | | | 1,159,488 | | | | 1,780,668 | | | | 3,756,721 | | | | 3,628,747 | |
Total operating expenses | | | 3,264,282 | | | | 4,288,221 | | | | 10,109,751 | | | | 7,376,175 | |
Loss from operations | | | (3,264,282) | | | | (4,288,221) | | | | (10,109,751) | | | | (7,376,175) | |
Other income (expense): | | | | | | | | | | | | | | | | |
Change in fair value of accrued license fees | | | — | | | | — | | | | — | | | | (9,381,848) | |
Change in fair value of debt conversion feature liability | | | (64,514) | | | | (197,496) | | | | 444,083 | | | | (826,637) | |
Amortization of debt discount | | | (431,227) | | | | (240,515) | | | | (1,356,861) | | | | (652,986) | |
Amortization of financing costs | | | (45,852) | | | | — | | | | (45,852) | | | | — | |
Interest expense, net | | | (1,556) | | | | (10,312) | | | | (18,832) | | | | (75,379) | |
Total other income (expense) | | | (543,149) | | | | (448,323) | | | | (977,462) | | | | (10,936,850) | |
Net loss | | | (3,807,431) | | | | (4,736,544) Werbung Mehr Nachrichten zur Viking Therapeutics Inc Aktie kostenlos abonnieren
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