SAN DIEGO, May 10, 2017 /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 first quarter ended March 31, 2017, and provided an update on its
clinical pipeline and other corporate developments.
Highlights from, and Subsequent to, the Quarter Ended
March 31, 2017
"We continued to make solid progress with multiple programs in
the first quarter," stated Brian
Lian, Ph.D., chief executive officer of Viking. "The
Phase 2 trial of our selective androgen receptor modulator (SARM)
VK5211 for hip fracture is nearing full enrollment, targeting
up to 120 patients with recent fractures. The Phase 2 trial
of our novel thyroid receptor agonist VK2809 in fatty liver disease
and hypercholesterolemia is also continuing to enroll new
patients. We expect to report initial results from the VK5211
study later this summer, and expect to complete the VK2809 trial in
the second half of the year. In addition, we continue to
advance our two orphan disease programs, both of which have the
potential to produce first-in-class therapies for serious unmet
medical needs. In the second half of the year we plan to file
an IND and initiate a proof-of-concept study of VK2809 in glycogen
storage disease, type Ia (GSD Ia). We also recently completed
an extended dosing study of VK0214 in an in vivo model of
X-linked adrenoleukodystrophy (X-ALD) and expect to announce
the results during the second quarter of 2017. On the
corporate side, we recently amended our Loan and Security Agreement
with Ligand to extend the maturity date of our loan to May
2018. As a result, we are in a stronger financial position
and able to focus on our important upcoming data readouts."
Pipeline and Corporate Highlights
- Phase 2 clinical trial of VK5211 in patients recovering from
hip fracture surgery nearing complete enrollment. VK5211
is a novel, orally available, non-steroidal small molecule
selective androgen receptor modulator (SARM) which has been shown
to have a stimulatory effect on lean body mass and bone mineral
density, and may offer significant benefits to patients recovering
from hip fracture surgery. The ongoing international trial
continues enrolling patients with recent fractures, targeting up to
120 subjects across four treatment arms. Patients receive
once daily oral doses of VK5211 for 12-weeks, and will be assessed
for changes in lean body mass, the trial's primary endpoint, as
well as various exploratory endpoints evaluating functional and
quality of life measures. Viking currently expects initial
data from this study to be available late this summer.
- Phase 2 clinical trial of VK2809 in fatty liver disease and
hypercholesterolemia continues to enroll. VK2809 is a
novel, orally available small molecule thyroid receptor agonist
that possesses selectivity for liver tissue as well as the beta
receptor subtype, suggesting promise in this patient
population. The ongoing trial is enrolling patients with
elevated LDL cholesterol (LDL-C) and non-alcoholic fatty liver
disease. Patients are randomized to receive once-daily oral
doses of VK2809 or placebo for 12 weeks followed by a four-week
off-drug phase. The trial's primary endpoint will evaluate
the effect of VK2809 treatment on LDL-C after 12 weeks compared to
placebo. Secondary and exploratory endpoints include
assessments of changes in liver fat content, inflammatory markers,
and liver stiffness. The company currently expects to complete
this trial in the fourth quarter of 2017.
- Proof-of-concept study to evaluate VK2809 for the treatment
of glycogen storage disease type Ia (GSD Ia) planned for
2H17. GSD Ia is an orphan genetic disease that results in
an excess accumulation of glycogen and lipids in the liver,
potentially leading to hepatic steatosis, hepatic adenomas, and
hepatocellular carcinoma. Initial results from an in
vivo proof-of-concept study showed that treatment with VK2809
produced rapid and substantial reductions in liver triglyceride
content, liver weight and liver weight as a percentage of body
weight compared with vehicle-treated controls. Mean liver
triglyceride content was reduced by more than 60% in VK2809-treated
animals relative to vehicle-treated control animals, while average
liver weight was reduced by more than 30% vs. controls.
Complete results from this study, which is being conducted under a
sponsored research agreement between Duke
University and Viking, will be presented at a future
scientific meeting. The company plans to file an
Investigational New Drug (IND) application for VK2809 for the
treatment of patients with GSD Ia and initiate a human
proof-of-concept study in the second half of 2017.
- Evaluation of VK2809 in an in vivo model of
non-alcoholic steatohepatitis (NASH) recently completed.
VK2809 was recently evaluated in a model of diet-induced NASH,
designed to reflect many aspects of the disease, including
steatosis, inflammation, and fibrosis. Initial results from this
study are expected to be available in the second quarter of
2017.
- Evaluation of VK0214 in an in vivo model of X-linked
adrenoleukodystrophy (X-ALD) recently completed. VK0214
is a novel, orally available small molecule thyroid receptor
agonist that possesses selectivity for the beta receptor
subtype. Encouraging initial results from an in vivo
study of VK0214 in the ABCD1 knockout model of X-ALD were presented
at the American Thyroid Association meeting in September
2016. This study successfully achieved its primary objective,
demonstrating the ability of VK0214 to lower plasma very long chain
fatty acids (VLCFAs) after six weeks of treatment. The
accumulation of VLCFAs is believed to contribute to the underlying
pathology of X-ALD. Following this initial study, in the
fourth quarter of 2016, the company, in collaboration with the
Kennedy Krieger Institute, initiated a longer-term study to
evaluate the effects of VK0214 in this model. Initial results
from this study are expected to be available in the second quarter
of 2017.
- Amended Loan and Security Agreement with Ligand, extending
loan maturity date to May 2018.
Financial Highlights
Quarter Ended March 31, 2017
and 2016
Research and development expenses for the three months ended
March 31, 2017 were $3.5 million compared to $1.9 million for the same period in 2016. The
increase was primarily due to increased activities related to our
clinical trials for our VK5211 and VK2809 programs, third party
manufacturing of our clinical-stage drug candidates, and
pre-clinical efforts for our VK0214 program.
General and administrative expenses for the three months ended
March 31, 2017 were $1.4 million consistent with $1.4 million for the same period in 2016.
For the three months ended March 31,
2017, Viking reported a net loss of $5.2 million, or $0.23 per share, compared to a net loss of
$3.6 million, or $0.40 per share, in the corresponding period in
2016.
Balance Sheet as of March 31,
2017
At March 31, 2017, Viking held
cash, cash equivalents and investments totaling $12.3 million. As of April 30, 2017, Viking had 23,925,425 shares of
common stock outstanding.
Conference Call
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 17, 2017
by dialing (877) 344-7529 from the U.S. or (412) 317-0088 from
outside the U.S. and entering conference ID # 10106263. 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, and expectations
regarding an IND application for VK2809. 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)
|
|
|
|
|
|
|
Three Months
Ended
March
31,
|
|
|
|
2017
|
|
|
2016
|
|
Revenues
|
|
$
|
—
|
|
|
$
|
—
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
3,528,150
|
|
|
|
1,877,178
|
|
General and
administrative
|
|
|
1,440,512
|
|
|
|
1,390,239
|
|
Total operating
expenses
|
|
|
4,968,662
|
|
|
|
3,267,417
|
|
Loss from
operations
|
|
|
(4,968,662)
|
|
|
|
(3,267,417)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Change in fair value
of debt conversion feature liability
|
|
|
277,698
|
|
|
|
96,547
|
|
Amortization of debt
discount
|
|
|
(431,227)
|
|
|
|
(400,657)
|
|
Amortization of
financing costs
|
|
|
(98,179)
|
|
|
|
—
|
|
Interest expense,
net
|
|
|
(1,530)
|
|
|
|
(15,461)
|
|
Total other income
(expense), net
|
|
|
(253,238)
|
|
|
|
(319,571)
|
|
Net loss
|
|
|
(5,221,900)
|
|
|
|
(3,586,988)
|
|
Other comprehensive
gain (loss), net of tax:
|
|
|
|
|
|
|
|
|
Unrealized gain (loss)
on securities
|
|
|
(607)
|
|
|
|
7,175
|
|
Comprehensive
loss
|
|
$
|
(5,222,507)
|
|
|
$
|
(3,579,813)
|
|
Basic and diluted net
loss per share
|
|
$
|
(0.23)
|
|
|
$
|
(0.40)
|
|
Weighted-average
shares used to compute basic
and
diluted net loss per share
|
|
|
22,352,921
|
|
|
|
9,015,778
|
|
Viking
Therapeutics, Inc.
Balance
Sheets
|
|
|
|
|
|
|
|
|
|
March 31,
2017
|
|
|
December 31,
2016
|
|
|
|
(Unaudited)
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
4,359,046
|
|
|
$
|
3,075,502
|
|
Short-term investments
– available for sale
|
|
|
7,954,240
|
|
|
|
10,075,058
|
|
Prepaid clinical trial
costs
|
|
|
2,183,180
|
|
|
|
541,603
|
|
Prepaid expenses and
other current assets
|
|
|
177,451
|
|
|
|
282,666
|
|
Total current
assets
|
|
|
14,673,917
|
|
|
|
13,974,829
|
|
Deferred public
offering and other financing costs
|
|
|
439,349
|
|
|
|
521,538
|
|
Deposits
|
|
|
39,341
|
|
|
|
39,341
|
|
Total
assets
|
|
$
|
15,152,607
|
|
|
$
|
14,535,708
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
1,726,824
|
|
|
$
|
1,203,888
|
|
Other accrued
liabilities
|
|
|
1,655,342
|
|
|
|
1,237,122
|
|
Accrued interest,
current
|
|
|
—
|
|
|
|
34,894
|
|
Convertible notes
payable, current (net of discount of $0 and $675,589 at March 31,
2017 and December 31, 2016, respectively)
|
|
|
—
|
|
|
|
3,269,582
|
|
Debt conversion
feature liability, current
|
|
|
—
|
|
|
|
731,048
|
|
Total current
liabilities
|
|
|
3,382,166
|
|
|
|
6,476,534
|
|
Accrued interest,
non-current
|
|
|
47,113
|
|
|
|
—
|
|
Convertible notes
payable (net of discount of $244,362 and $0 at March 31, 2017 and
December 31, 2016, respectively)
|
|
|
3,713,029
|
|
|
|
—
|
|
Debt conversion
feature liability
|
|
|
453,350
|
|
|
|
—
|
|
Deferred
rent
|
|
|
10,862
|
|
|
|
16,307
|
|
Total long-term
liabilities
|
|
|
4,224,354
|
|
|
|
16,307
|
|
Total
liabilities
|
|
|
7,606,520
|
|
|
|
6,492,841
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
Preferred stock,
$0.00001 par value: 10,000,000 shares authorized at March 31, 2017
and December 31, 2016; no shares issued and outstanding at March
31, 2017 and December 31, 2016
|
|
|
—
|
|
|
|
—
|
|
Common stock, $0.00001
par value: 300,000,000 shares authorized at March 31, 2017 and
December 31, 2016; 23,925,425 and 20,823,873 shares issued and
outstanding at March 31, 2017 and December 31, 2016,
respectively.
|
|
|
239
|
|
|
|
208
|
|
Additional paid-in
capital
|
|
|
73,052,514
|
|
|
|
68,326,818
|
|
Accumulated
deficit
|
|
|
(65,499,167)
|
|
|
|
(60,277,267)
|
|
Accumulated other
comprehensive loss
|
|
|
(7,499)
|
|
|
|
(6,892)
|
|
Total stockholders'
equity
|
|
|
7,546,087
|
|
|
|
8,042,867
|
|
Total liabilities and
stockholders' equity
|
|
$
|
15,152,607
|
|
|
$
|
14,535,708
|
|
Follow Viking on Twitter @Viking_VKTX.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/viking-therapeutics-reports-first-quarter-2017-financial-results-and-provides-corporate-update-300455553.html
SOURCE Viking Therapeutics, Inc.