SAN DIEGO, Aug. 1, 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 second quarter ended June 30, 2019, and provided an update on its
clinical pipeline and other corporate developments.
Highlights from the Quarter, and Subsequent to June 30, 2019:
"The second quarter was an especially active period at
Viking, highlighted by our presentation of additional
VK2809 clinical data, as well as continued progress toward our
planned Phase 2b study in
biopsy-confirmed NASH," stated Brian
Lian, Ph.D., chief executive officer of Viking
Therapeutics. "New data presented at EASL from our
completed Phase 2a study of VK2809 further validated the
compound's potency at reducing liver fat and plasma lipids, even at
the lowest evaluated dose of 5 mg per day, and provided additional
encouraging safety data. As we look to the second half of the
year, we've been working diligently to prepare for our next study,
which will be a Phase 2b study in
patients with biopsy-confirmed NASH. We currently expect to
file an IND with the FDA's GI division and initiate this study
by year-end. In addition to our progress with VK2809, we
continue to advance our IND-enabling work for VK0214 for the
treatment of X-ALD and expect to initiate a Phase 1 clinical trial
in the first half of 2020. Finally, to support these
endeavors, we continue to carefully manage spending. We completed
the quarter with over $290 million in
cash, which we believe is sufficient to support operations through
multiple important clinical milestones."
Pipeline and Corporate Highlights
- VK2809 Phase 2 data presented at the Late-Breaker poster
session of the 2019 EASL conference. In the second quarter, the
company presented additional data from the completed Phase 2 study
of VK2809 in patients with non-alcoholic fatty liver disease
(NAFLD) and hypercholesterolemia. As previously disclosed, these
results demonstrated that VK2809 doses as low as 5 mg daily
produced statistically significant reductions in liver fat content,
as well as improvements in plasma lipids. Patients receiving VK2809
also experienced statistically significant improvements in response
rates, defined by the proportion of patients experiencing at least
a 30% or 50% relative reduction in liver fat, compared with
placebo. VK2809 was well-tolerated at all doses in this study, with
no serious adverse events reported among patients receiving either
VK2809 or placebo. These results were presented in April at the
Late-Breaker poster session at the annual meeting of the European
Association for the Study of the Liver (EASL), in Vienna, Austria.
- Pre-IND package submitted for VK2809; Initiation of Phase
2b NASH trial planned in 2H19.
The company recently submitted a pre-investigational new drug
(pre-IND) meeting briefing package to the Food and Drug
Administration (FDA) for VK2809 and expects to receive
written feedback from the agency in the coming weeks. 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 the Division of Gastroenterology and Inborn
Errors Products. The company expects to file an IND application for
VK2809 and initiate a Phase 2b study
in patients with biopsy-confirmed non-alcoholic steatohepatitis
(NASH) in 2H19.
- Continued progress with IND-enabling work for VK0214;
Initiation of Phase 1 trial planned in 1H20. VK0214 is being
evaluated as a potential treatment for X-linked
adrenoleukodystrophy (X-ALD), a devastating disease caused by a
defect in a peroxisomal transporter called ABCD1. Defects in this
transporter are believed to contribute to an accumulation of very
long chain fatty acids (VLCFAs), and the resulting neuronal and
neuromuscular toxicities observed in X-ALD patients. VK0214 is an
orally available, small molecule thyroid receptor agonist that
possesses similar characteristics to VK2809, including selectivity
for the beta receptor subtype. To date, results from in
vitro and in vivo studies of VK0214 have been
encouraging. Administration of VK0214 has been shown to stimulate
the metabolism of VLCFAs, resulting in a significant reduction of
these lipids in both plasma and tissue. IND-enabling work for this
program continues to advance and the company plans to initiate a
Phase 1 clinical trial in 1H20.
- Kathy Rouan, Ph.D. appointed
to Viking board of directors. The company recently announced
the appointment of Kathy Rouan,
Ph.D. to its board of directors. With nearly 30 years of
pharmaceutical industry experience, Dr. Rouan provides Viking with
drug discovery and development expertise across a broad range of
therapeutic areas including gastroenterology, cardiovascular,
immune-inflammation and oncology.
- Balance sheet remains strong with over $290 million in cash and equivalents. Viking
completed the second quarter of 2019 with approximately
$293 million in cash, cash
equivalents, and short-term investments.
- Upcoming investor events. Viking management will
participate in the following upcoming investor events:
Citi's 14th Annual
Biotech Conference
Dates: September 4
- 5, 2019
Location: Four Seasons Hotel, Boston,
MA
Morgan Stanley 17th
Annual Global Healthcare Conference
Dates: September 9 - 11, 2019
Location: Grand Hyatt, New York,
NY
Cantor Global Healthcare
Conference
Dates: October 2 - 4,
2019
Location: Intercontinental New York Barclay Hotel, New York, NY
Q2 and Six-Month 2019 Financial Highlights
Second Quarter Ended June 30,
2019 and 2018
Research and development expenses for
the three months ended June 30, 2019
were $7.3 million compared to
$5.2 million for the same period in
2018. The increase was primarily due to increased
manufacturing expenses related to our drug candidates, pre-clinical
study activities, salaries and benefits, use of third-party
consultants, and stock-based compensation expenses, partially
offset by a decrease in clinical study expenses.
General and administrative expenses for the three months ended
June 30, 2019 were $2.2 million compared to $1.7 million for the same period in 2018.
The increase was primarily due to increased stock-based
compensation expense, salaries and benefits, use of third-party
consultants and professional fees.
For the three months ended June 30,
2019, Viking reported a net loss of $7.7 million, or $0.11 per share, compared to a net loss of
$6.7 million, or $0.13 per share, in the corresponding period in
2018. The increase in net loss for the three months ended
June 30, 2019 was primarily due to
the increases in research and development expenses and general and
administrative expenses noted previously, partially offset by an
increase in other income related to the increase in interest
income. The decrease in net loss per share for the three
months ended June 30, 2019 was
primarily due to the additional shares outstanding at June 30, 2019 versus those outstanding at
June 30, 2018, given the additional
shares issued by the Company since June
2018, primarily through public equity offerings.
Six Months Ended June 30, 2019
and 2018
Research and development expenses for the six
months ended June 30, 2019 were
$11.8 million compared to
$8.3 million for the same period in
2018. The increase was primarily due to increased
manufacturing expenses related to our drug candidates, pre-clinical
study activities, salaries and benefits, use of third-party
consultants and stock-based compensation expense partially offset
by a decrease in clinical study expenses.
General and administrative expenses for the six months ended
June 30, 2019 were $4.5 million compared to $3.5 million for the same period in 2018.
The increase was primarily due to increased stock-based
compensation expense, salaries and benefits, use of third-party
consultants, corporate and professional fees.
For the six months ended June 30,
2019 Viking reported a net loss of $12.6 million, or $0.18 per share, compared to a net loss of
$10.2 million, or $0.21 per share, in the corresponding period in
2018. The increase in net loss for the six months ended
June 30, 2019 was primarily due to
increased research and development and general and administrative
expenses noted previously, partially offset by an increase in other
income related to the decrease in the fair value of the debt
conversion feature liability, as well as an increase in interest
income. The decrease in net loss per share for the six months
ended June 30, 2019 was primarily
driven by the additional shares outstanding at June 30, 2019 versus those outstanding at
June 30, 2018, given the additional
shares issued by the Company since June
2018, primarily through public equity offerings.
Balance Sheet as of June 30,
2019
At June 30, 2019, Viking held
cash, cash equivalents and short-term investments totaling
$292.6 million. As of
July 31, 2019, Viking had 72,204,380
shares of common stock outstanding.
Conference Call
Management will host a conference call to discuss the company's
second quarter 2019 financial results today at 4:30 pm 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
August 8, 2019 by dialing (877)
344-7529 from the U.S. or (412) 317-0088 from outside the U.S. and
entering conference ID # 10132584. 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
June
30,
|
|
|
Six Months
Ended
June
30,
|
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
Revenues
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
7,333
|
|
|
|
5,221
|
|
|
|
11,828
|
|
|
|
8,264
|
|
General and
administrative
|
|
|
2,236
|
|
|
|
1,704
|
|
|
|
4,547
|
|
|
|
3,466
|
|
Total operating
expenses
|
|
|
9,569
|
|
|
|
6,925
|
|
|
|
16,375
|
|
|
|
11,730
|
|
Loss from
operations
|
|
|
(9,569)
|
|
|
|
(6,925)
|
|
|
|
(16,375)
|
|
|
|
(11,730)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value
of debt conversion feature liability
|
|
|
—
|
|
|
|
37
|
|
|
|
—
|
|
|
|
1,398
|
|
Amortization of debt
discount
|
|
|
—
|
|
|
|
(146)
|
|
|
|
—
|
|
|
|
(404)
|
|
Amortization of
financing costs
|
|
|
(30)
|
|
|
|
(30)
|
|
|
|
(60)
|
|
|
|
(60)
|
|
Interest income,
net
|
|
|
1,925
|
|
|
|
392
|
|
|
|
3,839
|
|
|
|
573
|
|
Realized loss on
investments
|
|
|
—
|
|
|
|
—
|
|
|
|
(2)
|
|
|
|
—
|
|
Total other income,
net
|
|
|
1,895
|
|
|
|
253
|
|
|
|
3,777
|
|
|
|
1,507
|
|
Net loss
|
|
|
(7,674)
|
|
|
|
(6,672)
|
|
|
|
(12,598)
|
|
|
|
(10,223)
|
|
Other comprehensive
loss, net of tax:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss)
on securities
|
|
|
288
|
|
|
|
(38)
|
|
|
|
662
|
|
|
|
(127)
|
|
Comprehensive
loss
|
|
$
|
(7,386)
|
|
|
$
|
(6,710)
|
|
|
$
|
(11,936)
|
|
|
$
|
(10,350)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
|
$
|
(0.11)
|
|
|
$
|
(0.13)
|
|
|
$
|
(0.18)
|
|
|
$
|
(0.21)
|
|
Weighted-average
shares used to compute basic and diluted net loss per
share
|
|
|
71,921
|
|
|
|
52,767
|
|
|
|
71,839
|
|
|
|
48,730
|
|
Viking
Therapeutics, Inc.
|
Balance
Sheets
|
(In thousands,
except share and per share amounts)
|
|
|
|
June 30,
2019
|
|
|
December 31,
2018
|
|
|
|
(Unaudited)
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
19,123
|
|
|
$
|
24,779
|
|
Short-term investments
– available for sale
|
|
|
273,513
|
|
|
|
276,741
|
|
Prepaid clinical trial
and preclinical study costs
|
|
|
343
|
|
|
|
335
|
|
Prepaid expenses and
other current assets
|
|
|
665
|
|
|
|
278
|
|
Total current
assets
|
|
|
293,644
|
|
|
|
302,133
|
|
Right-of-use
assets
|
|
|
730
|
|
|
|
—
|
|
Deferred public
offering and other financing costs
|
|
|
90
|
|
|
|
150
|
|
Deposits
|
|
|
29
|
|
|
|
29
|
|
Total
assets
|
|
$
|
294,493
|
|
|
$
|
302,312
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
1,870
|
|
|
$
|
959
|
|
Other accrued
liabilities
|
|
|
3,468
|
|
|
|
3,591
|
|
Lease liability,
current
|
|
|
288
|
|
|
|
—
|
|
Total current
liabilities
|
|
|
5,626
|
|
|
|
4,550
|
|
Deferred
rent
|
|
|
—
|
|
|
|
12
|
|
Lease liability, net
of current portion
|
|
|
513
|
|
|
|
—
|
|
Total long-term
liabilities
|
|
|
513
|
|
|
|
12
|
|
Total
liabilities
|
|
|
6,139
|
|
|
|
4,562
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
Stockholders' equity:
|
|
|
|
|
|
|
|
|
Preferred stock,
$0.00001 par value: 10,000,000 shares authorized at June 30, 2019
and December 31, 2018; no shares issued and outstanding at June 30,
2019 and December 31, 2018
|
|
|
—
|
|
|
|
—
|
|
Common stock, $0.00001
par value: 300,000,000 shares authorized at June 30, 2019 and
December 31, 2018; 72,173,489 and 71,742,043 shares issued and
outstanding at June 30, 2019 and December 31, 2018,
respectively
|
|
|
1
|
|
|
|
1
|
|
Additional paid-in
capital
|
|
|
403,630
|
|
|
|
401,090
|
|
Accumulated
deficit
|
|
|
(115,516)
|
|
|
|
(102,918)
|
|
Accumulated other
comprehensive income (loss)
|
|
|
239
|
|
|
|
(423)
|
|
Total
stockholders' equity
|
|
|
288,354
|
|
|
|
297,750
|
|
Total liabilities and
stockholders' equity
|
|
$
|
294,493
|
|
|
$
|
302,312
|
|
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SOURCE Viking Therapeutics, Inc.