SAN DIEGO, March 7, 2018 /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, 2017, and provided an
update on its clinical pipeline and other corporate
developments.
Highlights from, and Subsequent to, the Quarter Ended
December 31, 2017
"The last year has been transformative for Viking as we
announced positive clinical data for our lead program, VK5211 for
hip fracture, advanced our Phase 2 clinical trial evaluating VK2809
for liver disease, and achieved multiple milestones with our
earlier-stage programs targeting glycogen storage disease type Ia
(GSD Ia) and X-linked adrenoleukodystrophy (X-ALD)," stated
Brian Lian, Ph.D., chief executive
officer of Viking. "To support our continued progress, in
February 2018 we raised an additional
$63 million in gross proceeds,
providing resources to support multiple programs through key
inflection points. Our recent financings have also
strengthened Viking's shareholder base through the addition of
multiple fundamental, long-term life science investors, and we
appreciate their support. Looking to the balance of 2018, we
plan to submit the detailed results from the VK5211 study for
presentation at a scientific conference, initiate a
proof-of-concept study of VK2809 in GSD Ia, announce top-line data
from our ongoing Phase 2 study of VK2809 in fatty liver disease and
hypercholesterolemia, and file an investigational new drug (IND)
application for VK0214 in X-ALD. Each of these events
represents an exciting potential milestone for the company."
Pipeline and Corporate Highlights
- Phase 2 clinical trial of VK5211 in patients recovering from
hip fracture meets primary and secondary endpoints.
VK5211 is an orally available, non-steroidal selective androgen
receptor modulator (SARM) designed to selectively stimulate muscle
and bone formation with reduced activity in peripheral tissues such
as skin and prostate. In November
2017, the company announced positive results from a 12-week,
Phase 2 clinical trial of VK5211 in patients who recently suffered
a hip fracture.
Top-line data showed that the Phase 2 trial achieved its primary
endpoint, demonstrating statistically significant, dose dependent
increases in lean body mass, less head, following treatment with
VK5211 as compared to placebo. The study also achieved
important secondary endpoints, demonstrating statistically
significant increases in appendicular lean body mass and total lean
body mass for all doses of VK5211, compared to placebo. While
not powered for significance, patients receiving VK5211
demonstrated numerical improvements in certain exploratory
assessments of functional performance, including the 6-minute walk
test and short physical performance battery, compared with placebo.
In addition, VK5211 demonstrated encouraging safety and
tolerability in this study, with no drug-related serious adverse
events (SAEs) reported. Viking plans to meet with the
appropriate regulatory agencies in the second half of 2018 to
discuss next steps for this program and is evaluating options for
advancing VK5211, including partnering.
- 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. This study is evaluating two potential
indications: hypercholesterolemia 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-cholesterol after 12 weeks compared to
placebo. Secondary and exploratory endpoints include assessments of
changes in liver fat content, inflammatory markers, and plasma
lipids. This trial continues to enroll new patients and the company
expects to announce results in the second half of 2018.
- Proof-of-concept study of VK2809 in GSD Ia expected to begin
in 1H18. 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. In 2017, the company announced positive
findings from an in vivo study evaluating VK2809 as a
potential treatment for GSD Ia. In this study, 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 demonstrated VK2809's potent, rapid-acting effects in liver
tissue and support advancement of the candidate into the clinic.
The company plans to begin dosing patients in a Phase 1 clinical
trial in the second quarter of 2018.
- IND-enabling work for VK0214 in X-ALD underway. VK0214
is a novel, orally available small molecule thyroid receptor
agonist that possesses selectivity for the beta receptor subtype.
Data from an in vivo proof-of-concept study of VK0214 in
X-ALD were presented at the 87th Annual Meeting of the American
Thyroid Association, in Victoria, British
Columbia. 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 thyroid receptor beta (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 support for the role of selective TRb activation as a
potential therapeutic approach to the disease. The company plans to
file an IND for VK0214 in X-ALD in the fourth quarter of 2018.
- Financings raise approximately $78
million. In the fourth quarter of 2017 and first quarter
of 2018 Viking received a total of approximately $78.0 million in gross proceeds through the
issuance of common stock. These proceeds will be used to support
the company's ongoing development programs, partnering efforts and
other corporate activities.
Financial Highlights
Fourth Quarter Ended December 31,
2017 and 2016
Research and development expenses for the three months ended
December 31, 2017 were $3.0 million compared to $2.6 million for the same period in 2016.
The increase was primarily due to increased activities
related to our VK2809 clinical development program.
General and administrative expenses for the three months ended
December 31, 2017 were $1.4 million compared to $1.1 million for the same period in 2016.
The increase was primarily due to increases in salaries and
benefits-related expense.
For the three months ended December 31,
2017, Viking reported a net loss of $4.1 million, or $0.14 per share, compared to a net loss of
$3.6 million, or $0.18 per share, in the corresponding period in
2016. The increase in net loss for the three months ended
December 31, 2017 was primarily due
to the increase in research and development expenses and general
and administrative expenses noted previously.
Twelve Months Ended December 31,
2017 and 2016
Research and development expenses for the twelve months ended
December 31, 2017 were $13.7 million compared to $9.0 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 twelve months ended
December 31, 2017 were $5.3 million compared to $4.8 million for the same period in 2016.
This increase was primarily due to increases in salaries and
benefits-related expense, offset by a decrease in non-cash stock
compensation expense.
For the twelve months ended December 31,
2017, Viking reported a net loss of $20.6 million, or $0.79 per share, compared to a net loss of
$14.7 million, or $0.90 per share, in the comparable period in
2016. The increase in net loss for the twelve months ended
December 31, 2017 was primarily due
to the increase in research and development expenses and general
and administrative expenses noted previously as well as a decrease
in the change in fair value of debt conversation feature
liability.
Balance Sheet as of December 31,
2017
At December 31, 2017, Viking held
cash, cash equivalents and investments totaling $20.6 million. In February 2018, Viking sold an aggregate of
12,650,000 shares of its common stock resulting in gross proceeds
of $63.3 million before deducting
underwriting discounts and commissions and other offering
expenses. As of February 28,
2018, Viking had 50,898,802 shares of common stock
outstanding.
Conference Call
Management will host a conference call to discuss the company's
fourth 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
March 14, 2018 by dialing (877)
344-7529 from the U.S. or (412) 317-0088 from outside the U.S. and
entering conference ID #10117261. 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 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
December 31,
|
|
|
Year Ended
December 31,
|
|
|
|
2017
|
|
|
2016
|
|
|
2017
|
|
|
2016
|
|
Revenues
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
3,033,018
|
|
|
|
2,647,469
|
|
|
|
13,741,186
|
|
|
|
9,000,499
|
|
General and
administrative
|
|
|
1,394,235
|
|
|
|
1,090,054
|
|
|
|
5,329,003
|
|
|
|
4,846,776
|
|
Total operating
expenses
|
|
|
4,427,253
|
|
|
|
3,737,523
|
|
|
|
19,070,189
|
|
|
|
13,847,275
|
|
Loss from
operations
|
|
|
(4,427,253)
|
|
|
|
(3,737,523)
|
|
|
|
(19,070,189)
|
|
|
|
(13,847,275)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value
of debt conversion feature liability
|
|
|
632,628
|
|
|
|
620,087
|
|
|
|
344,928
|
|
|
|
1,064,170
|
|
Amortization of debt
discount
|
|
|
(258,152)
|
|
|
|
(431,227)
|
|
|
|
(1,282,631)
|
|
|
|
(1,788,088)
|
|
Amortization of
financing costs
|
|
|
(33,516)
|
|
|
|
(92,849)
|
|
|
|
(571,044)
|
|
|
|
(138,701)
|
|
Interest income
(expense), net
|
|
|
1,820
|
|
|
|
(3,098)
|
|
|
|
1,271
|
|
|
|
(21,928)
|
|
Total other income
(expense)
|
|
|
342,780
|
|
|
|
92,913
|
|
|
|
(1,507,476)
|
|
|
|
(884,547)
|
|
Net loss
|
|
|
(4,084,473)
|
|
|
|
(3,644,610)
|
|
|
|
(20,577,665)
|
|
|
|
(14,731,822)
|
|
Other comprehensive
loss, net of tax:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss)
on securities
|
|
|
(16,212)
|
|
|
|
(755)
|
|
|
|
(12,877)
|
|
|
|
478
|
|
Comprehensive
loss
|
|
$
|
(4,100,685)
|
|
|
$
|
(3,645,365)
|
|
|
$
|
(20,590,542)
|
|
|
$
|
(14,731,344)
|
|
Basic and diluted net
loss per share
|
|
$
|
(0.14)
|
|
|
$
|
(0.18)
|
|
|
$
|
(0.79)
|
|
|
$
|
(0.90)
|
|
Weighted-average
shares used to compute basic
and
diluted net loss per share
|
|
|
29,871,781
|
|
|
|
19,930,096
|
|
|
|
25,978,098
|
|
|
|
16,278,292
|
|
Viking
Therapeutics, Inc.
Balance
Sheets
|
|
|
|
December 31,
2017
(unaudited)
|
|
|
December 31,
2016
|
|
Assets
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
8,988,478
|
|
|
$
|
3,075,502
|
|
Short-term investments
– available for sale
|
|
|
11,587,478
|
|
|
|
10,075,058
|
|
Prepaid clinical trial
costs
|
|
|
886,873
|
|
|
|
541,603
|
|
Prepaid expenses and
other current assets
|
|
|
388,969
|
|
|
|
282,666
|
|
Total current
assets
|
|
|
21,851,798
|
|
|
|
13,974,829
|
|
Deferred public
offering and other financing costs
|
|
|
269,613
|
|
|
|
521,538
|
|
Deposits
|
|
|
—
|
|
|
|
39,341
|
|
Total
assets
|
|
$
|
22,121,411
|
|
|
$
|
14,535,708
|
|
Liabilities,
convertible notes and stockholders'
equity
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
1,529,935
|
|
|
$
|
1,203,888
|
|
Other accrued
liabilities
|
|
|
2,256,543
|
|
|
|
1,237,122
|
|
Accrued
interest
|
|
|
21,960
|
|
|
|
34,894
|
|
Convertible notes
payable, current portion (net of discount of $404,437 and $675,589
at December 31, 2017 and 2016, respectively)
|
|
|
3,450,540
|
|
|
|
3,269,582
|
|
Debt conversion
feature liability
|
|
|
1,397,597
|
|
|
|
731,048
|
|
Total current
liabilities
|
|
|
8,656,575
|
|
|
|
6,476,534
|
|
Deferred
rent
|
|
|
—
|
|
|
|
16,307
|
|
Total long-term
liabilities
|
|
|
—
|
|
|
|
16,307
|
|
Total
liabilities
|
|
|
8,656,575
|
|
|
|
6,492,841
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
Preferred stock,
$0.00001 par value: 10,000,000 shares authorized at December 31,
2017 and 2016; no shares issued and outstanding at December 31,
2017 and 2016
|
|
|
—
|
|
|
|
—
|
|
Common stock, $0.00001
par value: 300,000,000 shares authorized at December 31, 2017 and
2016; 35,817,104 shares issued and outstanding at December 31, 2017
and 20,823,873 shares issued and outstanding at December 31,
2016
|
|
|
358
|
|
|
|
208
|
|
Additional paid-in
capital
|
|
|
94,339,179
|
|
|
|
68,326,818
|
|
Accumulated
deficit
|
|
|
(80,854,932)
|
|
|
|
(60,277,267)
|
|
Accumulated other
comprehensive loss
|
|
|
(19,769)
|
|
|
|
(6,892)
|
|
Total stockholders'
equity
|
|
|
13,464,836
|
|
|
|
8,042,867
|
|
Total liabilities and
stockholders' equity
|
|
$
|
22,121,411
|
|
|
$
|
14,535,708
|
|
Follow Viking on Twitter @Viking_VKTX.
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SOURCE Viking Therapeutics, Inc.