SAN DIEGO, Aug. 9, 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 second quarter ended June 30,
2017, and provided an update on its clinical pipeline and
other corporate developments.
Highlights from, and Subsequent to, the Quarter Ended
June 30, 2017
"We are excited about the progress we've made during the past
several months, particularly with respect to our VK5211 and VK2809
programs. We completed enrollment in our Phase 2 trial of
VK5211 in patients recovering from hip fracture surgery, and look
forward to announcing the results in the fourth quarter. We
also completed the opening of all planned clinical sites in our
VK2809 Phase 2 trial for non-alcoholic fatty liver disease (NAFLD)
and hypercholesterolemia and continue to enroll new patients.
In addition, we announced positive results from a study of VK2809
in a model of diet-induced NASH, which showed statistically
significant reductions in fibrosis, liver collagen, liver
steatosis, and the NAFLD activity score (NAS). The histologic
improvements observed in this study suggest an encouraging
potential benefit in settings such as NASH and glycogen storage
disease (GSD)," stated Brian Lian,
Ph.D., chief executive officer of Viking.
"Our orphan drug programs also advanced during the
quarter. We are currently preparing to file an
Investigational New Drug (IND) application for VK2809 for the
treatment of patients with GSD Ia and plan to initiate a
proof-of-concept study for this indication later this year.
And, through our collaboration with the Kennedy Krieger Institute,
we recently completed a 25-week in vivo study of our second
thyroid receptor agonist, VK0214, in a model of X-linked
adrenoleukodystrophy (X-ALD). We plan to report the results
from this study later this quarter. In order to support our
development activities, we strengthened our balance sheet during
the quarter by raising gross proceeds of $4.3 million, providing a financial runway into
2018. Finally, we also expanded our board of directors with
the appointment of Charles A. Rowland,
Jr., an experienced biopharma finance executive. As
Viking's pipeline grows and matures, we expect Charlie's financial
and operational expertise will prove invaluable."
Pipeline and Corporate Highlights
- Enrollment completed in Phase 2 clinical trial of VK5211 in
patients recovering from hip fracture surgery. 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 Phase 2 clinical trial is a randomized,
double-blind, placebo-controlled, parallel group 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 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. Viking expects to announce
results from this trial in the fourth quarter of 2017.
- 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. The company has recently completed all
planned site openings for the trial and is actively 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 plasma lipids. In an effort to facilitate enrollment in this
study, the company, following discussions with the FDA, recently
amended the trial protocol to widen certain eligibility criteria,
while maintaining the rigor and integrity of the trial. This
protocol amendment is currently being implemented across all sites.
The company expects to announce the results from this trial in the
first half of 2018.
- Results from an in vivo evaluation of VK2809 in a
model of diet-induced NASH demonstrated broad histologic benefits
including an improvement in fibrosis. In June, Viking announced
additional data supporting the efficacy and unique liver-targeting
mechanism of VK2809. Results showed statistically significant
reductions in fibrosis, liver collagen, liver and plasma lipids,
and the non-alcoholic fatty liver disease activity score (NAS),
which is a composite measure of steatosis, inflammation and
ballooning. Highlights from this study include:
-
- Liver triglyceride content was reduced by 70% compared to
vehicle control (p<0.0001), and by 56% compared to active
control (p<0.0001)
- Liver cholesterol content was reduced by 65% compared to
vehicle control (p<0.0001) and by 58% compared to active control
(p<0.0001)
- Liver fibrosis was reduced by 50% compared to vehicle control
(p=0.01) and by 21% compared to active control (p=0.3)
- Liver collagen content was reduced by 60% compared to vehicle
control (p<0.005) and by 49% compared to active control
(p=0.07)
- Liver hydroxyproline content was reduced by 46% compared to
vehicle control (p=0.01) and by 36% compared to active control
(p=0.06)
- Animals treated with VK2809 experienced a 40% mean improvement
in NAS after eight weeks compared to vehicle-treated controls
(p<0.0001; average baseline NAS 5.7; n = 12/cohort); and 50% of
VK2809-treated animals demonstrated at least a two-point
improvement in NAS compared with no vehicle-treated animals
demonstrating at least a two-point improvement (p=0.01)
- No animals treated with VK2809 demonstrated a worsening in NAS
vs. approximately 60% of vehicle-treated animals demonstrating a
worsening (p<0.0001)
- Treatment with VK2809 also produced significant reductions in
plasma triglycerides and cholesterol.
- 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. The company plans to file an 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 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. In the
fourth quarter of 2016, the company, in collaboration with the
Kennedy Krieger Institute, initiated a long term in vivo
study to evaluate the effects of VK0214 in the ABCD1 knockout model
of X-ALD. This study has recently been completed and initial
results are expected to be available later this quarter.
- Completed private placement raising $4.3 million in gross proceeds. Funds from
the private placement will be used for general corporate purposes
including the company's ongoing Phase 2 trials for VK5211 and
VK2809, and advancing these programs into later stage development.
In addition, these funds will support the preclinical and early
clinical development of our GSD la and X-ALD programs.
- Appointed Charles A. Rowland,
Jr., to the Viking 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
Second Quarter Ended June 30,
2017 and 2016
Research and development expenses for the three months ended
June 30, 2017 were $3.7 million compared to $2.4 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
preclinical efforts for our VK0214 program.
General and administrative expenses for the three months ended
June 30, 2017 were $1.3 million compared to $1.2 million for the same period in 2016. This
small increase was primarily due to increases in salaries and
benefits and legal expenses, offset by a decrease in non-cash stock
compensation expense.
For the three months ended June 30,
2017, Viking reported a net loss of $5.2 million, or $0.21 per share, compared to a net loss of
$3.7 million, or $0.22 per share, in the corresponding period in
2016. The increase in net loss for the three months ended
June 30, 2017 was primarily due to
the increase in research and development expenses noted
previously.
Six Months Ended June 30, 2017
and 2016
Research and development expenses for the six months ended
June 30, 2017 were $7.2 million compared to $4.2 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, as well as third party manufacturing of our clinical-stage
drug candidates.
General and administrative expenses for the six months ended
June 30, 2017 were $2.7 million compared to $2.6 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 six months ended June 30,
2017, Viking reported a net loss of $10.4 million, or $0.45 per share, compared to a net loss of
$7.3 million, or $0.56 per share, in the comparable period in
2016. The increase in net loss for the six months ended
June 30, 2017 was primarily due to
the increase in research and development expenses noted
previously.
Balance Sheet as of June 30,
2017
At June 30, 2017, Viking held
cash, cash equivalents and investments totaling $12.1 million. As of July 31, 2017, Viking had 27,697,284 shares of
common stock outstanding.
Conference Call
Management will host a conference call to discuss the company's
second 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
August 16, 2017 by dialing (877)
344-7529 from the U.S. or (412) 317-0088 from outside the U.S. and
entering conference ID # 10110737. 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 and VK2809 and their respective prospects. 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
June
30,
|
|
|
Six Months
Ended
June
30,
|
|
|
|
2017
|
|
|
2016
|
|
|
2017
|
|
|
2016
|
|
Revenues
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
3,715,379
|
|
|
|
2,371,058
|
|
|
|
7,243,529
|
|
|
|
4,248,236
|
|
General and
administrative
|
|
|
1,267,364
|
|
|
|
1,206,995
|
|
|
|
2,707,876
|
|
|
|
2,597,233
|
|
Total operating
expenses
|
|
|
4,982,743
|
|
|
|
3,578,053
|
|
|
|
9,951,405
|
|
|
|
6,845,469
|
|
Loss from
operations
|
|
|
(4,982,743)
|
|
|
|
(3,578,053)
|
|
|
|
(9,951,405)
|
|
|
|
(6,845,469)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value
of debt conversion feature liability
|
|
|
570,676
|
|
|
|
412,050
|
|
|
|
848,374
|
|
|
|
508,597
|
|
Amortization of debt
discount
|
|
|
(336,656)
|
|
|
|
(524,977)
|
|
|
|
(767,883)
|
|
|
|
(925,634)
|
|
Amortization of
financing costs
|
|
|
(421,781)
|
|
|
|
—
|
|
|
|
(519,960)
|
|
|
|
—
|
|
Interest expense,
net
|
|
|
(1,130)
|
|
|
|
(1,813)
|
|
|
|
(2,660)
|
|
|
|
(17,275)
|
|
Total other income
(expense), net
|
|
|
(188,891)
|
|
|
|
(114,740)
|
|
|
|
(442,129)
|
|
|
|
(434,312)
|
|
Net
loss
|
|
|
(5,171,634)
|
|
|
|
(3,692,793)
|
|
|
|
(10,393,534)
|
|
|
|
(7,279,781)
|
|
Other comprehensive
gain (loss), net of tax:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss)
on securities
|
|
|
1,500
|
|
|
|
(6,591)
|
|
|
|
893
|
|
|
|
584
|
|
Comprehensive
loss
|
|
$
|
(5,170,134)
|
|
|
$
|
(3,699,384)
|
|
|
$
|
(10,392,641)
|
|
|
$
|
(7,279,197)
|
|
Basic and diluted net
loss per share
|
|
$
|
(0.21)
|
|
|
$
|
(0.22)
|
|
|
$
|
(0.45)
|
|
|
$
|
(0.56)
|
|
Weighted-average
shares used to compute basic and
diluted net loss per share
|
|
|
24,118,887
|
|
|
|
17,105,374
|
|
|
|
23,240,782
|
|
|
|
13,060,576
|
|
Viking
Therapeutics, Inc.
|
Balance
Sheets
|
|
|
|
June 30,
2017
|
|
|
December 31,
2016
|
|
|
|
(Unaudited)
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
3,393,651
|
|
|
$
|
3,075,502
|
|
Short-term investments
– available for sale
|
|
|
8,689,630
|
|
|
|
10,075,058
|
|
Prepaid clinical trial
costs
|
|
|
1,732,789
|
|
|
|
541,603
|
|
Prepaid expenses and
other current assets
|
|
|
447,932
|
|
|
|
282,666
|
|
Total current
assets
|
|
|
14,264,002
|
|
|
|
13,974,829
|
|
Deferred public
offering and other financing costs
|
|
|
17,568
|
|
|
|
521,538
|
|
Deposits
|
|
|
39,341
|
|
|
|
39,341
|
|
Total
assets
|
|
$
|
14,320,911
|
|
|
$
|
14,535,708
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
1,304,711
|
|
|
$
|
1,203,888
|
|
Other accrued
liabilities
|
|
|
2,418,355
|
|
|
|
1,237,122
|
|
Accrued interest,
current
|
|
|
59,333
|
|
|
|
34,894
|
|
Convertible notes
payable, current (net of discount of $919,184 and $675,589 at June
30, 2017 and December 31, 2016, respectively)
|
|
|
3,050,427
|
|
|
|
3,269,582
|
|
Debt conversion
feature liability, current
|
|
|
894,152
|
|
|
|
731,048
|
|
Total current
liabilities
|
|
|
7,726,978
|
|
|
|
6,476,534
|
|
Deferred
rent
|
|
|
6,054
|
|
|
|
16,307
|
|
Total long-term
liabilities
|
|
|
6,054
|
|
|
|
16,307
|
|
Total
liabilities
|
|
|
7,733,032
|
|
|
|
6,492,841
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
Preferred stock,
$0.00001 par value: 10,000,000 shares authorized at June 30, 2017
and December 31, 2016; no shares issued and outstanding at June 30,
2017 and December 31, 2016
|
|
|
—
|
|
|
|
—
|
|
Common stock, $0.00001
par value: 300,000,000 shares authorized at June 30, 2017 and
December 31, 2016; 27,697,284 and 20,823,873 shares issued and
outstanding at June 30, 2017 and December 31, 2016,
respectively
|
|
|
277
|
|
|
|
208
|
|
Additional paid-in
capital
|
|
|
77,264,402
|
|
|
|
68,326,818
|
|
Accumulated
deficit
|
|
|
(70,670,801)
|
|
|
|
(60,277,267)
|
|
Accumulated other
comprehensive loss
|
|
|
(5,999)
|
|
|
|
(6,892)
|
|
Total stockholders'
equity
|
|
|
6,587,879
|
|
|
|
8,042,867
|
|
Total liabilities and
stockholders' equity
|
|
$
|
14,320,911
|
|
|
$
|
14,535,708
|
|
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SOURCE Viking Therapeutics, Inc.