SAN DIEGO, Nov. 8, 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 third quarter ended September 30, 2017, and provided an update on its
clinical pipeline and other corporate developments.
Highlights from, and Subsequent to, the Quarter Ended
September 30, 2017
"The last few months have been an exciting time at Viking as we
continued moving forward with multiple pipeline programs.
Since our last update we presented positive data from three
different programs at scientific conferences, which served to
underscore the depth and quality of our pipeline. Looking
ahead, we remain on track to announce by year-end the results from
a Phase 2 trial of our novel SARM program VK5211 in patients
recovering from hip fracture," stated Brian
Lian, Ph.D., chief executive officer of Viking. "We
are also continuing to enroll patients in the Phase 2 trial of our
novel thyroid receptor beta agonist VK2809 in hypercholesterolemia
and fatty liver disease, and we expect to complete this study in
the first half of 2018. With respect to our orphan programs,
we made progress with both VK2809 in glycogen storage disease and
VK0214 in X-ALD and we're excited by recent results from each
program. On the corporate side, during the quarter we entered
into stock purchase agreements for up to $16.25 million with an institutional investor,
providing financing flexibility. We also added to our Board
of Directors through the appointment of Charles A. Rowland, Jr., an experienced
biopharma finance executive."
Pipeline and Corporate Highlights
- Phase 2 clinical trial of VK5211 in patients recovering from
hip fracture surgery nearing completion; data expected 4Q 2017.
VK5211 is a novel, orally available, non-steroidal small molecule
selective androgen receptor modulator (SARM) which has been shown
to have stimulatory effects on lean body mass and bone mineral
density, and may offer significant benefits to patients recovering
from hip fracture surgery. The Phase 2 clinical trial is a
randomized, double-blind, placebo-controlled, parallel group
international study designed to evaluate the efficacy, safety and
tolerability of VK5211 in patients recovering from hip fracture
surgery. A total of 108 patients have been randomized to receive
oral once-daily VK5211 doses of 0.5 mg, 1.0 mg, 2.0 mg, or placebo
for 12 weeks. The study's primary endpoint will evaluate 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 pharmacokinetics.
- Phase 2 clinical trial of VK2809 in non-alcoholic fatty
liver disease (NAFLD) 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. 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-cholesterol after 12
weeks compared to placebo. Secondary and exploratory endpoints
include assessments of changes in liver fat content, inflammatory
markers, and plasma lipids. The company expects to complete this
trial in the first half of 2018.
- Final results from in vivo evaluation of VK2809 in a
model of diet-induced NASH presented at The Liver Meeting®
2017, the annual meeting of the American Association for the
Study of Liver Diseases (AASLD), in Washington D.C. Results from this study
demonstrated statistically significant reductions in fibrosis,
steatosis and the NAFLD activity score in animals treated with
VK2809 compared with vehicle-treated controls. Gene expression
analyses demonstrated significant improvements in multiple genes
related to fibrosis, steatosis, and metabolic control. The
presentation received a Presidential Poster of Distinction Award
from the AASLD, awarded to the top 10% of presentations.
- Results from in vivo proof-of-concept study of VK2809
in glycogen storage disease type Ia (GSD Ia) presented at the 13th
International Congress of Inborn Errors of Metabolism (ICIEM),
in Rio De Janeiro, Brazil. Results
from this study demonstrated that VK2809 produced statistically
significant improvements in multiple measures of metabolic control
compared with vehicle. Treatment with VK2809 led to significant
reductions in liver triglycerides, liver weight, and other
metabolic markers in the glucose-6-phosphatase (G6PC) knockout
mouse model, which is intended to replicate the impairment of this
enzyme's function in patients with GSD Ia. The results highlighted
VK2809's potent, rapid-acting effects in liver tissue. 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.
- Data from in vivo proof-of-concept study of VK0214 in
X-linked adrenoleukodystrophy (X-ALD) presented at the 87th Annual
Meeting of the American Thyroid Association, in Victoria, British Columbia. VK0214 is a novel,
orally available small molecule thyroid receptor agonist that
possesses selectivity for the beta receptor subtype. The results of
this study demonstrated that long-term (25 week) treatment with
VK0214 produced statistically significant reductions in plasma and
tissue levels of very long chain fatty acids (VLCFAs) compared to
vehicle-treated controls. VLCFA levels in central nervous system
(CNS) tissues were also significantly reduced, suggesting a
potential direct benefit in both brain and spinal cord. Treatment
with VK0214 was also shown to stimulate significant increases in
ABCD2 transporter expression in CNS tissue, providing further
evidence of its effect beyond plasma exposures. These study results
were consistent with the proposed mechanism of TRb-mediated
reductions in VLCFA levels, as ABCD2 is regulated by TRb and known
to play a role in VLCFA metabolism. The successful outcome of this
work serves to provide additional support for the role of selective
thyroid receptor beta (TRb) activation as a potential therapeutic
approach to the disease.
- Entered into stock purchase agreements for up to
$16.25 million. During the third
quarter, the company entered into common stock purchase agreements
for up to $16.25 million with an
institutional investor. Under the terms of the agreements, Viking
will control the timing and amount of any future sale of shares of
common stock to the investor.
- Appointed Charles A. Rowland,
Jr., to board of directors. Mr. Rowland has more than 30
years of biopharmaceutical industry experience spanning financial
management and strategic business operations. During his career, he
has acted as CEO, CFO or a director for numerous biotech companies
at Viking's stage, providing valuable guidance on financings, drug
development operations and commercialization.
Financial Highlights
Third Quarter Ended September 30,
2017 and 2016
Research and development expenses for the three months ended
September 30, 2017 were $3.5 million compared to $2.1 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, preclinical
efforts for our VK0214 program as well as services provided by
certain third-party consultants.
General and administrative expenses for the three months ended
September 30, 2017 were $1.2 million which was consistent with
$1.2 million for the same period in
2016.
For the three months ended September 30,
2017, Viking reported a net loss of $6.1 million, or $0.22 per share, compared to a net loss of
$3.8 million, or $0.20 per share, in the corresponding period in
2016. The increase in net loss for the three months ended
September 30, 2017 was primarily due
to the increase in research and development expenses noted
previously and an increase in expense related to the change in fair
value of debt conversion feature liability.
Nine Months Ended September 30,
2017 and 2016
Research and development expenses for the nine months ended
September 30, 2017 were $10.7 million compared to $6.4 million for the same period in 2016. 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, third party manufacturing of our clinical-stage drug
candidates, as well as regulatory and other consulting services
provided by certain third-party consultants.
General and administrative expenses for the nine months ended
September 30, 2017 were $3.9 million compared to $3.8 million for the same period in 2016. This
small increase was primarily due to increases in salaries and
benefits, offset by a decrease in non-cash stock compensation
expense.
For the nine months ended September 30,
2017, Viking reported a net loss of $16.5 million, or $0.67 per share, compared to a net loss of
$11.1 million, or $0.74 per share, in the comparable period in
2016. The increase in net loss for the nine months ended
September 30, 2017 was primarily due
to the increase in research and development expenses noted
previously.
Balance Sheet as of September 30,
2017
At September 30, 2017, Viking held
cash, cash equivalents and investments totaling $9.8 million. As of October 31, 2017, Viking had 28,498,847 shares of
common stock outstanding.
Conference Call
Management will host a conference call to discuss the
company's third 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 November 16, 2017 by
dialing (877) 344-7529 from the U.S. or (412) 317-0088 from outside
the U.S. and entering conference ID # 10113999. 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 non-alcoholic
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.
Follow Viking on Twitter @Viking_VKTX.
Forward-Looking Statements
This press release contains forward-looking statements
regarding Viking Therapeutics, 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,
and potential future sales of shares under the company's recent
stock purchase agreements. 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, including those for VK5211 and
VK2809; risks that prior clinical and preclinical results may not
be replicated; and risks regarding regulatory requirements, among
others. 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
September
30,
|
|
|
Nine Months
Ended
September
30,
|
|
|
|
2017
|
|
|
2016
|
|
|
2017
|
|
|
2016
|
|
Revenues
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
3,464,639
|
|
|
|
2,104,794
|
|
|
|
10,708,169
|
|
|
|
6,353,030
|
|
General and
administrative
|
|
|
1,226,892
|
|
|
|
1,159,488
|
|
|
|
3,934,768
|
|
|
|
3,756,721
|
|
Total operating
expenses
|
|
|
4,691,531
|
|
|
|
3,264,282
|
|
|
|
14,642,937
|
|
|
|
10,109,751
|
|
Loss from
operations
|
|
|
(4,691,531)
|
|
|
|
(3,264,282)
|
|
|
|
(14,642,937)
|
|
|
|
(10,109,751)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value
of debt conversion feature liability
|
|
|
(1,136,074)
|
|
|
|
(64,514)
|
|
|
|
(287,700)
|
|
|
|
444,083
|
|
Amortization of debt
discount
|
|
|
(256,596)
|
|
|
|
(431,227)
|
|
|
|
(1,024,479)
|
|
|
|
(1,356,861)
|
|
Amortization of
financing costs
|
|
|
(17,568)
|
|
|
|
(45,852)
|
|
|
|
(537,528)
|
|
|
|
(45,852)
|
|
Interest income
(expense), net
|
|
|
2,111
|
|
|
|
(1,556)
|
|
|
|
(548)
|
|
|
|
(18,832)
|
|
Total other expense,
net
|
|
|
(1,408,127)
|
|
|
|
(543,149)
|
|
|
|
(1,850,255)
|
|
|
|
(977,462)
|
|
Net loss
|
|
|
(6,099,658)
|
|
|
|
(3,807,431)
|
|
|
|
(16,493,192)
|
|
|
|
(11,087,213)
|
|
Other comprehensive
gain (loss), net of tax:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain on
securities
|
|
|
2,442
|
|
|
|
649
|
|
|
|
3,334
|
|
|
|
1,233
|
|
Comprehensive
loss
|
|
$
|
(6,097,216)
|
|
|
$
|
(3,806,782)
|
|
|
$
|
(16,489,858)
|
|
|
$
|
(11,085,980)
|
|
Basic and diluted net
loss per share
|
|
$
|
(0.22)
|
|
|
$
|
(0.20)
|
|
|
$
|
(0.67)
|
|
|
$
|
(0.74)
|
|
Weighted-average
shares used to compute basic and diluted net loss per share
|
|
|
27,469,784
|
|
|
|
18,991,971
|
|
|
|
24,665,941
|
|
|
|
15,052,139
|
|
Viking
Therapeutics, Inc.
|
Balance
Sheets
|
|
|
|
September 30,
2017
|
|
|
December 31,
2016
|
|
|
|
(Unaudited)
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
2,568,063
|
|
|
$
|
3,075,502
|
|
Short-term investments
– available for sale
|
|
|
7,270,719
|
|
|
|
10,075,058
|
|
Prepaid clinical trial
costs
|
|
|
1,346,171
|
|
|
|
541,603
|
|
Prepaid expenses and
other current assets
|
|
|
340,121
|
|
|
|
282,666
|
|
Total current
assets
|
|
|
11,525,074
|
|
|
|
13,974,829
|
|
Deferred public
offering and other financing costs
|
|
|
275,029
|
|
|
|
521,538
|
|
Deposits
|
|
|
39,341
|
|
|
|
39,341
|
|
Total
assets
|
|
$
|
11,839,444
|
|
|
$
|
14,535,708
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
1,555,472
|
|
|
$
|
1,203,888
|
|
Other accrued
liabilities
|
|
|
2,837,392
|
|
|
|
1,237,122
|
|
Accrued interest,
current
|
|
|
9,982
|
|
|
|
34,894
|
|
Convertible notes
payable, current (net of discount of $662,588 and $675,589 at
September 30, 2017 and December 31, 2016, respectively)
|
|
|
3,180,411
|
|
|
|
3,269,582
|
|
Debt conversion
feature liability, current
|
|
|
2,030,226
|
|
|
|
731,048
|
|
Total current
liabilities
|
|
|
9,613,483
|
|
|
|
6,476,534
|
|
Deferred
rent
|
|
|
—
|
|
|
|
16,307
|
|
Total long-term
liabilities
|
|
|
—
|
|
|
|
16,307
|
|
Total
liabilities
|
|
|
9,613,483
|
|
|
|
6,492,841
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
Preferred stock,
$0.00001 par value: 10,000,000 shares authorized at September 30,
2017 and December 31, 2016; no shares issued and outstanding at
September 30, 2017 and December 31, 2016
|
|
|
—
|
|
|
|
—
|
|
Common stock, $0.00001
par value: 300,000,000 shares authorized at September 30, 2017 and
December 31, 2016; 28,498,847 and 20,823,873 shares issued and
outstanding at September 30, 2017 and December 31, 2016,
respectively
|
|
|
285
|
|
|
|
208
|
|
Additional paid-in
capital
|
|
|
78,999,693
|
|
|
|
68,326,818
|
|
Accumulated
deficit
|
|
|
(76,770,459)
|
|
|
|
(60,277,267)
|
|
Accumulated other
comprehensive loss
|
|
|
(3,558)
|
|
|
|
(6,892)
|
|
Total stockholders'
equity
|
|
|
2,225,961
|
|
|
|
8,042,867
|
|
Total liabilities and
stockholders' equity
|
|
$
|
11,839,444
|
|
|
$
|
14,535,708
|
|
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SOURCE Viking Therapeutics, Inc.