SAN DIEGO, Nov. 5, 2019 /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,
2019, and provided an update on its clinical pipeline and
other corporate developments.
Highlights from the Quarter, and Subsequent to September 30, 2019:
"The last few months have been an exciting and productive period
at Viking as we prepare for important near-term milestones," stated
Brian Lian, Ph.D., chief executive
officer of Viking Therapeutics. "With respect to our thyroid
receptor beta agonist VK2809, in the third quarter we completed key
chronic toxicity studies to support long-term dosing in
humans. This work, along with data from completed clinical
and other non-clinical studies, formed the basis of an IND
application that was submitted to the FDA to initiate a Phase
2b study of VK2809 in patients with
biopsy-confirmed NASH. With respect to VK0214, our second
thyroid receptor beta agonist, we continued the IND-enabling work
that will allow us to initiate clinical development, including a
proof-of-concept study in patients with X-ALD, in the first half of
next year. In addition to advancing our clinical programs,
we've also maintained a tight focus on operating expenses, and
ended the quarter with approximately $290
million in cash and equivalents. We believe our
current balance sheet is sufficient to see us through multiple
value inflection points."
Pipeline and Corporate Highlights
- Investigational New Drug (IND) application filed for Phase
2b study of VK2809 in
biopsy-confirmed non-alcoholic steatohepatitis (NASH).
VK2809 is an orally available small molecule agonist of the thyroid
hormone receptor that possesses selectivity for liver tissue, as
well as the beta receptor subtype, suggesting promising therapeutic
potential in a range of lipid disorders, including NASH. In
September 2018, we announced positive
results from a Phase 2 trial of VK2809 in patients with
hypercholesterolemia and non-alcoholic fatty liver disease.
This Phase 2 trial evaluated VK2809 doses of 5 mg daily, 10 mg
daily, 10 mg every other day, or placebo, for 12 weeks. The
trial achieved its key primary and secondary endpoints,
demonstrating potent reductions in liver fat content and plasma
lipids.
The company recently completed chronic toxicity studies to support
long-term dosing of VK2809 in humans. The results from
certain of these studies, along with additional clinical and
non-clinical data, formed the basis of an IND application that was
recently filed with the FDA's Division of Gastrointestinal and
Inborn Errors Products (DGIEP). A new IND is required as the
existing IND is filed with the FDA's Division of Metabolic and
Endocrinology Products, while most NASH drugs are reviewed in
DGIEP. Pending clearance of the IND, the company plans to
initiate a Phase 2b study of VK2809
in patients with biopsy-confirmed NASH.
- IND-enabling work for VK0214 ongoing; Clinical studies
expected to begin 1H20. VK0214 is being evaluated as
a potential treatment for X-linked adrenoleukodystrophy, or X-ALD -
a devastating disease for which there is no therapeutic
treatment. X-ALD is caused by a defect in the ABCD1
peroxisomal transporter. This defect can result in an
accumulation of very long chain fatty acids in plasma and tissue,
which is believed to contribute to the severe cerebral and motor
neuron toxicities that are characteristic of the disease. To date,
results from in vitro and in vivo studies have
demonstrated that administration of VK0214 results in a significant
reduction of very long chain fatty acids in both plasma and tissue,
potentially leading to a therapeutic benefit. These promising
results for VK0214 were achieved through the company's ongoing
collaboration with the Kennedy Krieger Institute – one of the
world's leading X-ALD research centers. IND-enabling work for
VK0214 continues to advance and the company plans to initiate a
Phase 1 clinical trial in 1H20.
- Balance sheet remains strong with approximately $290 million in cash. Viking completed
the third quarter of 2019 with $288.1
million in cash, cash equivalents, and short-term
investments.
- Upcoming investor events. Viking management will
participate in the following upcoming investor events:
William Blair Boston Innovation
Day (at AASLD)
Date: November 12,
2019
Location: Boston, MA
Stifel 2019 Healthcare
Conference
Dates: November 19 - 20,
2019
Location: Lotte New York Palace Hotel, New York, NY
Jefferies London Healthcare
Conference
Dates: November 20 - 21,
2019
Location: Waldorf Hilton London, London
UK
Biotech Showcase
2020
Dates: January 13 – 15,
2020
Location: Hilton San Francisco Union Square, San Francisco, CA
Q3 and Nine-Month 2019 Financial Highlights
Third Quarter Ended September 30,
2019 and 2018
Research and development expenses for
the three months ended September 30,
2019 were $5.3 million
compared to $5.7 million for the same
period in 2018. The decrease in expenses was primarily due to
decreased stock-based compensation, manufacturing for our drug
candidates and clinical and pre-clinical studies, partially offset
by increased expenses related to services provided by third-party
consultants.
General and administrative expenses for the three months ended
September 30, 2019 were $2.2 million compared to $1.7 million for the same period in 2018.
The increase in expenses was primarily due to increased stock-based
compensation, services provided by third-party consultants and
professional fees, partially offset by decreased expenses related
to salaries and benefits.
For the three months ended September 30,
2019, Viking reported a net loss of $5.7 million, or $0.08 per share, compared to a net loss of
$6.6 million, or $0.11 per share, in the corresponding period in
2018. The decrease in net loss and net loss per share for the
three months ended September 30, 2019
was primarily due to increased interest income recorded in the
third quarter of 2019 versus that recorded in the same period of
2018.
Nine Months Ended September 30,
2019 and 2018
Research and development expenses for the nine months ended
September 30, 2019 were $17.1 million compared to $14.0 million for the same period in 2018.
The increase in expenses was primarily due to increased
manufacturing for our drug candidates, pre-clinical studies,
salaries and benefits and services provided by third-party
consultants, partially offset by decreased expenses related to
clinical studies.
General and administrative expenses for the nine months ended
September 30, 2019 were $6.7 million compared to $5.2 million for the same period in 2018.
The increase in expenses was primarily due to increased stock-based
compensation, services provided by third-party consultants and
professional fees.
For the nine months ended September 30,
2019, Viking reported a net loss of $18.3 million, or $0.25 per share, compared to a net loss of
$16.8 million, or $0.32 per share, in the corresponding period in
2018. The increase in net loss for the nine months ended
September 30, 2019 was primarily due
to the increased research and development and general and
administrative expenses noted previously, partially offset by
increased interest income as well as the elimination of expenses
related to the change in fair value of the debt conversion feature
liability due to the repayment of the Ligand Note in May
2018. The decrease in net loss per share for the nine months
ended September 30, 2019 was
primarily driven by the additional weighted average shares
outstanding at September 30, 2019
versus those weighted average shares outstanding at September 30, 2018, given the public equity
financings that occurred during 2018.
Balance Sheet as of September 30,
2019
At September 30, 2019, Viking held
cash, cash equivalents and short-term investments totaling
$288.1 million and had 72,255,876
shares of common stock outstanding.
Conference Call
Management will host a conference call to discuss the company's
third quarter 2019 financial results today at 8:30 a.m. Eastern. 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 12, 2019 by dialing (877)
344-7529 from the U.S. or (412) 317-0088 from outside the U.S. and
entering conference ID # 10136700. 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 is a clinical-stage biopharmaceutical company focused
on the development of novel, orally available, first-in-class or
best-in-class therapies for the treatment of metabolic and
endocrine disorders. Viking's research and development
activities leverage its expertise in metabolism to develop
innovative therapeutics designed to improve patients' lives.
The company's clinical programs include VK2809, a novel, orally
available, small molecule selective thyroid hormone receptor beta
agonist for the treatment of lipid and metabolic disorders,
including non-alcoholic steatohepatitis (NASH). In a Phase 2
trial for the treatment of non-alcoholic fatty liver disease
(NAFLD) and elevated LDL-C, patients who received VK2809
demonstrated statistically significant reductions in LDL-C and
liver fat content compared with patients who received
placebo. The company is also developing VK0214, a novel,
orally available, small molecule selective thyroid hormone receptor
beta agonist for the treatment of X-linked adrenoleukodystrophy
(X-ALD).
Viking's other programs include VK5211, an orally available,
non-steroidal selective androgen receptor modulator. In a
Phase 2 trial in patients recovering from hip fracture, patients
who received VK5211 experienced significant improvements in
measures of lean body mass compared with patients who received
placebo. Other programs also include VK0612, a
first-in-class, orally available drug candidate in Phase 2
development for the treatment of type 2 diabetes as well as two
earlier-stage programs targeting metabolic diseases and
anemia. The company holds exclusive worldwide rights to a
portfolio of five therapeutic programs, including those noted
above, which are based on small molecules licensed from Ligand
Pharmaceuticals Incorporated.
Follow Viking on Twitter @Viking_VKTX.
Forward-Looking Statements
This press
release contains forward-looking statements regarding Viking
Therapeutics, Inc., under the safe harbor provisions of the U.S.
Private Securities Litigation Reform Act of 1995, including
statements about Viking's expectations regarding its development
activities, timelines and milestones, as well as the company's
goals and plans regarding VK2809, VK0214 and their respective
prospects. Forward-looking statements are subject to risks and
uncertainties that could cause actual results to differ materially
and adversely 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 VK2809 and
VK0214; risks that prior clinical and preclinical results may not
be replicated; risks regarding regulatory requirements; and other
risks that are described in Viking's most recent periodic reports
filed with the Securities and Exchange Commission, including
Viking's Annual Report on Form 10-K for the year
ended December 31, 2018, and subsequent Quarterly Reports on
Form 10-Q, including the risk factors set forth in those filings.
These forward-looking statements speak only as of the date
hereof. Viking disclaims any obligation to update these
forward-looking statements except as required by law.
Viking
Therapeutics, Inc.
Statements of
Operations and Comprehensive Loss
|
|
(In
thousands, except per share amounts)
(Unaudited)
|
|
|
|
Three Months
Ended
September
30,
|
|
|
Nine Months
Ended
September
30,
|
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
Revenues
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
5,279
|
|
|
|
5,687
|
|
|
|
17,108
|
|
|
|
13,951
|
|
General and
administrative
|
|
|
2,160
|
|
|
|
1,707
|
|
|
|
6,706
|
|
|
|
5,173
|
|
Total operating
expenses
|
|
|
7,439
|
|
|
|
7,394
|
|
|
|
23,814
|
|
|
|
19,124
|
|
Loss from
operations
|
|
|
(7,439)
|
|
|
|
(7,394)
|
|
|
|
(23,814)
|
|
|
|
(19,124)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value
of debt conversion feature liability
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
1,398
|
|
Amortization of debt
discount
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(404)
|
|
Amortization of
financing costs
|
|
|
(40)
|
|
|
|
(30)
|
|
|
|
(100)
|
|
|
|
(90)
|
|
Interest income,
net
|
|
|
1,742
|
|
|
|
824
|
|
|
|
5,581
|
|
|
|
1,397
|
|
Realized gain on
investments, net
|
|
|
6
|
|
|
|
—
|
|
|
|
4
|
|
|
|
—
|
|
Total other income,
net
|
|
|
1,708
|
|
|
|
794
|
|
|
|
5,485
|
|
|
|
2,301
|
|
Net loss
|
|
|
(5,731)
|
|
|
|
(6,600)
|
|
|
|
(18,329)
|
|
|
|
(16,823)
|
|
Other comprehensive
loss, net of tax:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss)
on securities
|
|
|
(82)
|
|
|
|
30
|
|
|
|
580
|
|
|
|
(97)
|
|
Comprehensive
loss
|
|
$
|
(5,813)
|
|
|
$
|
(6,570)
|
|
|
$
|
(17,749)
|
|
|
$
|
(16,920)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
|
$
|
(0.08)
|
|
|
$
|
(0.11)
|
|
|
$
|
(0.25)
|
|
|
$
|
(0.32)
|
|
Weighted-average
shares used to compute basic and diluted net loss per
share
|
|
|
72,040
|
|
|
|
61,232
|
|
|
|
71,907
|
|
|
|
52,943
|
|
Viking
Therapeutics, Inc.
Balance
Sheets
|
|
(In thousands,
except share and per share amounts)
|
|
|
|
September 30,
2019
|
|
|
December 31,
2018
|
|
|
|
(Unaudited)
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
30,952
|
|
|
$
|
24,779
|
|
Short-term investments
– available for sale
|
|
|
257,120
|
|
|
|
276,741
|
|
Prepaid clinical trial
and preclinical study costs
|
|
|
612
|
|
|
|
335
|
|
Prepaid expenses and
other current assets
|
|
|
572
|
|
|
|
278
|
|
Total current
assets
|
|
|
289,256
|
|
|
|
302,133
|
|
Right-of-use
assets
|
|
|
664
|
|
|
|
—
|
|
Deferred public
offering and other financing costs
|
|
|
173
|
|
|
|
150
|
|
Deposits
|
|
|
29
|
|
|
|
29
|
|
Total
assets
|
|
$
|
290,122
|
|
|
$
|
302,312
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
2,095
|
|
|
$
|
959
|
|
Other accrued
liabilities
|
|
|
3,802
|
|
|
|
3,591
|
|
Lease liability,
current
|
|
|
295
|
|
|
|
—
|
|
Total current
liabilities
|
|
|
6,192
|
|
|
|
4,550
|
|
Deferred
rent
|
|
|
—
|
|
|
|
12
|
|
Lease liability, net
of current portion
|
|
|
438
|
|
|
|
—
|
|
Total long-term
liabilities
|
|
|
438
|
|
|
|
12
|
|
Total
liabilities
|
|
|
6,630
|
|
|
|
4,562
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
Stockholders' equity:
|
|
|
|
|
|
|
|
|
Preferred stock,
$0.00001 par value: 10,000,000 shares authorized at September 30,
2019 and December 31, 2018; no shares issued and outstanding at
September 30, 2019 and December 31, 2018
|
|
|
—
|
|
|
|
—
|
|
Common stock, $0.00001
par value: 300,000,000 shares authorized at September 30, 2019 and
December 31, 2018; 72,255,876, and 71,742,043 shares issued and
outstanding at September 30, 2019 and December 31, 2018,
respectively
|
|
|
1
|
|
|
|
1
|
|
Additional paid-in
capital
|
|
|
404,581
|
|
|
|
401,090
|
|
Accumulated
deficit
|
|
|
(121,247)
|
|
|
|
(102,918)
|
|
Accumulated other
comprehensive income (loss)
|
|
|
157
|
|
|
|
(423)
|
|
Total
stockholders' equity
|
|
|
283,492
|
|
|
|
297,750
|
|
Total liabilities and
stockholders' equity
|
|
$
|
290,122
|
|
|
$
|
302,312
|
|
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SOURCE Viking Therapeutics, Inc.