Quarterly Earnings
- Overview
- Stock Information
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- Shareholder Services
- Corporate Presentation
Highlights From, and Subsequent to, the Three Months Ended
"We made significant progress over the past several months, achieving key milestones with multiple drug programs," said
Dr. Lian further commented, "In corporate news, Viking successfully completed its initial public offering (IPO) in the second quarter, which generated net proceeds of
Pipeline and Corporate Highlights
- Filed and activated the IND for the clinical development of VK5211, an orally available, non-steroidal SARM for acute hip fracture. The initial portion of the planned clinical studies will evaluate the safety, tolerability and pharmacokinetic profile of VK5211 in healthy elderly subjects. This will be followed by a randomized, double-blind, parallel group, placebo-controlled Phase 2 study to evaluate the efficacy, safety and tolerability of VK5211 in subjects with acute hip fracture. Approximately 120 subjects will be enrolled in the efficacy study with the primary objective of determining the effects of VK5211 on lean body mass after 12 weeks of treatment. Secondary and exploratory objectives include assessments of functional performance, quality-of-life and activities of daily living, as well as safety, tolerability and pharmacokinetic assessments. We expect to dose the first subjects in these studies this quarter and complete enrollment in mid-2016.
- Announced plans to conduct a Phase 2 trial of VK2809, a tissue selective agonist of the thyroid beta receptor, in patients with hypercholesterolemia and fatty liver disease. The planned Phase 2 study will be a randomized, double-blind, parallel group, placebo-controlled trial designed to evaluate the efficacy, safety and tolerability of VK2809 in approximately 100 patients with elevated LDL cholesterol and fatty liver disease. The primary objective of the trial will be to measure the effect of VK2809 treatment on LDL cholesterol levels after 12 weeks of dosing. Exploratory endpoints will examine changes in liver fat, inflammatory markers, insulin sensitivity and other measures. We expect to initiate this study in the fourth quarter and complete the study in 2016.
- Completed in vitro analyses of the novel thyroid beta agonists VK0214 and VK2809 in models of the orphan disease X-linked adrenoleukodystrophy (X-ALD). The results demonstrate that both VK0214 and VK2809 stimulate robust induction of the ABCD2 transporter. This transporter functions as a compensatory mechanism for clearance of very long chain fatty acids (VLCFA). It is believed that lowering VLCFA levels may benefit X-ALD patients by reducing the likelihood of toxicities related to VLCFA accumulation. We plan to initiate studies to evaluate both molecules in an in vivo model of disease during the third quarter. With positive results, we plan to file an IND and initiate clinical studies in 2016.
- Completed our IPO, including the underwriters' full exercise of their over-allotment option, generating net proceeds of approximately
$22.3 million .
- Expanded and strengthened our team by adding key staff in the areas of clinical development, clinical operations, manufacturing, project management and finance.
- Relocated and consolidated our corporate headquarters to a state-of-the-art facility in
San Diego, CA.
Financial Highlights
Second Quarter Ending
Research and development expenses for the three months ended
General and administrative expenses for the three months ended
For the three months ended
Six Months Ending
Research and development expenses for the six months ended
General and administrative expenses for the six months ended
For the six months ended
Balance Sheet as of
At
More detailed financial information and analysis may be found in Viking's Quarterly Report on Form 10-Q, which will be filed on
About
Forward Looking Statements
This press release contains forward-looking statements regarding
Viking Therapeutics, Inc. | ||||
Statements of Operations and Comprehensive Loss | ||||
(Unaudited) | ||||
Three Months Ended June 30, |
Six Months Ended June 30, |
|||
2015 | 2014 | 2015 | 2014 | |
Revenues | $ — | $ — | $ — | $ — |
Operating expenses: | ||||
Research and development | 1,100,906 | 21,241,640 | 1,239,875 | 21,291,640 |
General and administrative | 1,526,008 | 513,991 | 1,848,079 | 673,729 |
Total operating expenses | 2,626,914 | 21,755,631 | 3,087,954 | 21,965,369 |
Loss from operations | (2,626,914) | (21,755,631) | (3,087,954) | (21,965,369) |
Other expenses: | ||||
Change in fair value of accrued license fees | 4,421,338 | 959,363 | 9,381,848 | 959,363 |
Change in fair value of debt conversion feature liability | 546,485 | (2,328) | 629,141 | 7,921 |
Amortization of debt discount | 240,515 | 60,603 | 412,471 | 66,982 |
Interest expense, net | 29,814 | 9,518 | 65,067 | 12,094 |
Total other expenses | 5,238,152 | 1,027,156 | 10,488,527 | 1,046,360 |
Net loss | (7,865,066) | (22,782,787) | (13,576,481) | (23,011,729) |
Basic and diluted net loss per share | $ (1.07) | $ (5.40) | $ (2.38) | $ (6.20) |
Weighted-average shares used to compute basic and diluted net loss per share | 7,331,861 | 4,221,757 | 5,711,735 | 3,709,557 |
Other comprehensive loss, net of tax: | ||||
Unrealized loss on securities | (12,461) | — | (12,461) | — |
Other comprehensive loss, net of tax | (12,461) | — | (12,461) | — |
Comprehensive loss | $ (7,877,527) | $ (22,782,787) | $ (13,588,942) | $ (23,011,729) |
Viking Therapeutics, Inc. | ||
Balance Sheets | ||
June 30, 2015 |
December 31, 2014 |
|
(Unaudited ) | ||
Assets | ||
Current assets: | ||
Cash and cash equivalents | $ 9,497,200 | $ 755,857 |
Short-term investments – available for sale | 12,162,251 | -- |
Prepaid expenses and other current assets | 610,198 | 17,827 |
Total current assets | 22,269,649 | 773,684 |
Deferred IPO financing costs | -- | 2,268,675 |
Other assets | -- | 775 |
Total assets | $ 22,269,649 | $ 3,043,134 |
Liabilities, convertible notes and stockholders' equity (deficit) | ||
Current liabilities: | ||
Accounts payable | $ 1,008,277 | $ 1,830,724 |
Accrued license fees | -- | 19,865,863 |
Other accrued liabilities | 119,647 | 380,257 |
Accrued interest | 121,111 | 77,222 |
Convertible notes payable, current portion (net of discount of $829,491 and $6,076 at June 30, 2015 and December 31, 2014, respectively) | 1,670,509 | 304,274 |
Debt conversion feature liability | 1,956,566 | 58,742 |
Total current liabilities | 4,876,110 | 22,517,082 |
Convertible notes payable (net of discount of $0 and $1,235,886 at June 30, 2015 and December 31, 2014, respectively) | -- | 1,264,114 |
Debt conversion feature liability | -- | 1,390,469 |
Total long-term liabilities | -- | 2,654,583 |
Total liabilities | 4,876,110 | 25,171,665 |
Commitments and Contingencies | ||
Stockholders' equity (deficit): | ||
Common stock, $0.00001 par value: 300,000,000 shares authorized at June 30, 2015 and 25,000,000 shares authorized at December 31, 2014; 9,783,312 shares issued and outstanding at June 30, 2015 and 6,000,000 shares issued and outstanding at December 31, 2014 | 98 | 60 |
Additional paid-in capital | 53,123,840 | 12,866 |
Accumulated other comprehensive loss | (12,461) | -- |
Accumulated deficit | (35,717,938) | (22,141,457) |
Total stockholders' equity (deficit) | 17,393,539 | (22,128,531) |
Total liabilities and stockholders' deficit | $ 22,269,649 | $ 3,043,134 |
CONTACT:
Viking Therapeutics, Inc.
Brian Lian, President and CEO
blian@vikingtherapeutics.com
858-704-4660
Vida Strategic Partners
Stephanie Diaz (Investors)
sdiaz@vidasp.com
415-675-7401
Tim Brons (Media)
tbrons@vidasp.com
(646) 319-8981