SAN DIEGO, March 21, 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 fourth quarter and year ended
December 31, 2016, and provided an
update on its clinical pipeline and other corporate
developments.
Highlights from, and Subsequent to, the Quarter Ended
December 31, 2016
"We made
excellent progress with multiple pipeline programs in 2016.
We continued enrolling patients into the Phase 2 trial of our
selective androgen receptor modulator VK5211 for hip fracture,
initiated a Phase 2 trial with our novel thyroid receptor beta
agonist VK2809 in fatty liver disease and hypercholesterolemia,
began planning for a proof-of-concept trial with VK2809 in GSD Ia,
a new orphan indication, and reported positive proof-of-concept
data from our second thyroid receptor agonist, VK0214, in an in
vivo model of the orphan disease X-linked
adrenoleukodystrophy. We expect this momentum to continue in
2017 as we plan to announce the results from the hip fracture study
mid-year, followed later in the year by the results from the fatty
liver and hypercholesterolemia trial. Each of these events
will mark a key milestone for the company, providing clinical data
in indications that each represent significant potential revenue
opportunities," stated Brian Lian,
Ph.D., chief executive officer of Viking. "We are also
continuing our strategic partnerships with the Kennedy Krieger
Institute and Duke University, which
together provide valuable support as we work to advance our two
orphan programs into clinical development. We believe VK2809
in GSD Ia and VK0214 in X-ALD each represent important
opportunities to apply our novel science to areas of high unmet
medical need. Finally, we were able to accomplish all of this
while maintaining a lean operating model, ending the year with a
strong cash position at over $13
million, and retaining access to approximately $14 million in additional funding through our
current equity line and ATM program."
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 120
total 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 data from
this study to be available in mid-2017.
- Phase 2 clinical trial of VK2809 in hypercholesterolemia and
fatty liver disease is progressing. 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 up to 80 patients with
hypercholesterolemia and fatty liver disease. The company
currently expects to complete this trial in late 2017.
- New program initiated to evaluate VK2809 for the
treatment of glycogen storage disease type Ia (GSD Ia).
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.
- Evaluation of VK0214 in X-linked adrenoleukodystrophy
(X-ALD) advancing. 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 Q4 2016, the company, in collaboration with
the Kennedy Krieger Institute, initiated a longer-tem study to
evaluate the effects of VK0214 in this model. Initial results
from this study are expected to be available in 2Q17.
- Funding secured to advance GSD Ia program. In
February 2017, Viking entered into an
agreement with a dedicated healthcare investment fund to support
the initial clinical development of the company's GSD Ia
program. With this funding, 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.
Financial Highlights
Quarter Ended December 31, 2016 and 2015
Research and development expenses for the three months ended
December 31, 2016 were $2.6 million compared to $3.2 million for the same period in 2015. The
decrease was primarily due to decreased activities related to third
party manufacturing of our clinical-stage drug
candidates.
General and administrative expenses for the three months ended
December 31, 2016 were $1.1 million compared to $1.4 million for the same period in 2015. The
decrease was primarily due to decreases in stock-based compensation
expense.
For the three months ended December 31,
2016, Viking reported a net loss of $3.6 million, or $0.18 per share, compared to a net loss of
$5.1 million, or $0.56 per share, in the corresponding period in
2015.
Year Ended December 31, 2016
and 2015
Research and development expenses for the year ended
December 31, 2016 were $9.0 million compared to $7.0 million for the same period in 2015. The
increase in research and development expenses was primarily related
to increases in expenses related to clinical trial activity for our
VK5211 and VK2809 programs and preclinical efforts for our VK0214
program.
General and administrative expenses for the year ended
December 31, 2016 were $4.8 million compared to $5.0 million for the same period in 2015. The
decrease in general and administrative expenses was primarily
related to a decrease in stock-based compensation expense, offset
by an increase in costs related to being a publicly traded
company.
For the year ended December 31,
2016, Viking reported a net loss of $14.7 million, or $0.90 per share, compared to a net loss of
$23.4 million, or $3.68 per share, in the comparable period in
2015. The decrease in net loss in the year ended December 31, 2016 was primarily due to a change
in fair value of accrued license fees expense of $9.4 million recorded in 2015 with no comparable
expense in 2016.
Balance Sheet as of December 31,
2016
At December 31, 2016, Viking held
cash, cash equivalents and investments totaling $13.2 million. As of February 28, 2017, Viking had 23,825,425 shares
of common stock outstanding.
Conference Call
To participate on the conference
call, 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 April 3, 2017 by dialing (877) 344-7529 from the
U.S. or (412) 317-0088 from outside the U.S. and entering
conference ID # 10102405. 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, expectations regarding an IND
application for VK2809, and Viking's ability to use its equity line
and ATM program for raising 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)
|
|
|
|
Three Months Ended
December 31,
|
|
|
Year Ended
December 31,
|
|
|
|
2016
|
|
|
2015
|
|
|
2016
|
|
|
2015
|
|
Revenues
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
2,647,469
|
|
|
|
3,219,414
|
|
|
|
9,000,499
|
|
|
|
6,966,842
|
|
General and
administrative
|
|
|
1,090,054
|
|
|
|
1,400,889
|
|
|
|
4,846,776
|
|
|
|
5,029,636
|
|
Total operating
expenses
|
|
|
3,737,523
|
|
|
|
4,620,303
|
|
|
|
13,847,275
|
|
|
|
11,996,478
|
|
Loss from
operations
|
|
|
(3,737,523)
|
|
|
|
(4,620,303)
|
|
|
|
(13,847,275)
|
|
|
|
(11,996,478)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value
of accrued license fees
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(9,381,848)
|
|
Change in fair value
of debt conversion feature liability
|
|
|
620,087
|
|
|
|
(216,841)
|
|
|
|
1,064,170
|
|
|
|
(1,043,478)
|
|
Amortization of debt
discount
|
|
|
(431,227)
|
|
|
|
(240,516)
|
|
|
|
(1,788,088)
|
|
|
|
(893,502)
|
|
Amortization of
financing costs
|
|
|
(92,849)
|
|
|
|
—
|
|
|
|
(138,701)
|
|
|
|
—
|
|
Interest expense,
net
|
|
|
(3,098)
|
|
|
|
(13,303)
|
|
|
|
(21,928)
|
|
|
|
(88,682)
|
|
Total other income
(expense)
|
|
|
92,913
|
|
|
|
(470,660)
|
|
|
|
(884,547)
|
|
|
|
(11,407,510)
|
|
Net loss
|
|
|
(3,644,610)
|
|
|
|
(5,090,963)
|
|
|
|
(14,731,822)
|
|
|
|
(23,403,988)
|
|
Other comprehensive
loss, net of tax:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss)
on securities
|
|
|
(755)
|
|
|
|
(4,848)
|
|
|
|
478
|
|
|
|
(7,370)
|
|
Comprehensive
loss
|
|
$
|
(3,645,365)
|
|
|
$
|
(5,095,811)
|
|
|
$
|
(14,731,344)
|
|
|
$
|
(23,411,358)
|
|
Basic and diluted net
loss per share
|
|
$
|
(0.18)
|
|
|
$
|
(0.56)
|
|
|
$
|
(0.90)
|
|
|
$
|
(3.68)
|
|
Weighted-average
shares used to compute basic
and diluted net loss
per share
|
|
|
19,930,096
|
|
|
|
9,012,768
|
|
|
|
16,278,292
|
|
|
|
6,355,869
|
|
Viking
Therapeutics, Inc.
|
Balance
Sheets
|
|
|
|
December 31,
2016
(unaudited)
|
|
|
December 31,
2015
|
|
Assets
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
3,075,502
|
|
|
$
|
768,550
|
|
Short-term investments
– available for sale
|
|
|
10,075,058
|
|
|
|
13,335,499
|
|
Prepaid expenses and
other current assets
|
|
|
824,269
|
|
|
|
1,097,599
|
|
Total current
assets
|
|
|
13,974,829
|
|
|
|
15,201,648
|
|
Deferred public
offering and other financing costs
|
|
|
521,538
|
|
|
|
157,455
|
|
Deposits
|
|
|
39,341
|
|
|
|
80,000
|
|
Total
assets
|
|
$
|
14,535,708
|
|
|
$
|
15,439,103
|
|
Liabilities,
convertible notes and stockholders' equity
(deficit)
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
1,203,888
|
|
|
$
|
592,414
|
|
Other accrued
liabilities
|
|
|
1,237,122
|
|
|
|
1,384,398
|
|
Accrued
interest
|
|
|
34,894
|
|
|
|
—
|
|
Convertible notes
payable, current portion (net of discount of $675,589 and $0 at
December 31, 2016 and 2015, respectively)
|
|
|
3,269,582
|
|
|
|
—
|
|
Debt conversion
feature liability
|
|
|
731,048
|
|
|
|
—
|
|
Total current
liabilities
|
|
|
6,476,534
|
|
|
|
1,976,812
|
|
Accrued interest,
non-current
|
|
|
—
|
|
|
|
183,611
|
|
Convertible notes
payable (net of discount of $0 and $348,460 at December 31, 2016
and 2015, respectively)
|
|
|
—
|
|
|
|
2,151,540
|
|
Debt conversion
feature liability
|
|
|
—
|
|
|
|
2,370,903
|
|
Deferred
rent
|
|
|
16,307
|
|
|
|
31,239
|
|
Total long-term
liabilities
|
|
|
16,307
|
|
|
|
4,737,293
|
|
Total
liabilities
|
|
|
6,492,841
|
|
|
|
6,714,105
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
Preferred stock,
$0.00001 par value: 10,000,000 shares authorized at December 31,
2016 and 2015; no shares issued and outstanding at December 31,
2016 and 2015
|
|
|
—
|
|
|
|
—
|
|
Common stock, $0.00001
par value: 300,000,000 shares authorized at December 31, 2016 and
2015; 20,823,873 shares issued and outstanding at December 31, 2016
and 9,683,741 shares issued and outstanding at December 31,
2015
|
|
|
208
|
|
|
|
97
|
|
Additional paid-in
capital
|
|
|
68,326,818
|
|
|
|
54,277,716
|
|
Accumulated
deficit
|
|
|
(60,277,267)
|
|
|
|
(45,545,445)
|
|
Accumulated other
comprehensive loss
|
|
|
(6,892)
|
|
|
|
(7,370)
|
|
Total stockholders'
equity
|
|
|
8,042,867
|
|
|
|
8,724,998
|
|
Total liabilities and
stockholders' equity
|
|
$
|
14,535,708
|
|
|
$
|
15,439,103
|
|
Follow Viking on Twitter @Viking_VKTX.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/viking-therapeutics-reports-fourth-quarter-and-year-end-2016-financial-results-and-provides-corporate-update-300427037.html
SOURCE Viking Therapeutics, Inc.