SAN DIEGO, March 13, 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 fourth quarter and year ended
December 31, 2018, and provided an
update on its clinical pipeline and other corporate
developments.
Highlights from the Quarter, and Subsequent to December 31, 2018:
"The past year has been a transformative period for Viking, and
we are excited to continue this momentum in 2019," stated
Brian Lian, Ph.D., chief executive
officer of Viking Therapeutics. "We were particularly pleased
in 2018 to have presented positive Phase 2 data from our novel
thyroid receptor beta agonist VK2809 in non-alcoholic fatty liver
disease at the AASLD conference, and honored that these results
were featured in the Best of AASLD conference highlights. We
plan to present additional, new results from this study at the
upcoming EASL conference in April, and remain on-track to file an
IND to initiate a study in biopsy-confirmed NASH later this year.
In addition, pre-IND work for our second thyroid receptor
agonist VK0214 continues to progress, and we plan to file an IND to
initiate clinical development by the end of the year. Thanks
to successful fundraising efforts in 2018, we ended the year with
more than $300 million on our balance
sheet, and are now capitalized to reach major inflection points for
multiple programs. Entering 2019, we are focused on executing
our operating plans and enthusiastic about the future development
of our pipeline."
Pipeline and Corporate Highlights
- Phase 2 study of VK2809 in patients with NAFLD and elevated
LDL-C highlighted at 2018 AASLD. VK2809 is a novel, orally
available small molecule thyroid receptor antagonist that possesses
selectivity for liver tissue, as well as the beta receptor subtype,
suggesting promise in certain metabolic and liver diseases,
including non-alcoholic steatohepatitis (NASH). In November 2018, the company's positive top-line
results from a 12-week Phase 2 study of VK2809 were presented at
the annual meeting of the American Association for the Study of
Liver Diseases (AASLD) as part of the Late-Breaking Abstract Oral
Session. The trial findings were also named to the Best of AASLD,
which highlighted the contributions of particular importance at the
annual meeting. The company is currently preparing to initiate a
Phase 2b study of VK2809 in
biopsy-confirmed NASH, which is anticipated to begin in the second
half of 2019.
- Additional VK2809 Phase 2 data to be presented at the
Late-Breaker poster session of the upcoming 2019 EASL
conference. The company recently received additional data from
the low-dose 5 mg cohort in the Phase 2 trial of VK2809 trial in
NAFLD and hypercholesterolemia. The results demonstrated that
patients receiving VK2809 experienced statistically significant
reductions in liver fat content relative to placebo, as well as
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.
Consistent with prior data from the 10 mg cohorts, VK2809 was well
tolerated when dosed at 5 mg daily, and no serious adverse events
were reported among patients receiving either VK2809 or placebo.
These results will be presented at the Late-Breaker poster session
at the upcoming annual meeting of the European Association for the
Study of Liver (EASL), April 11-14,
2019 in Vienna,
Austria.
- IND-enabling work for VK0214 in X-linked
adrenoleukodystrophy (X-ALD) progressing, IND filing planned
in 2019. VK0214 is a novel, orally available small molecule
thyroid receptor agonist that possesses selectivity for the beta
receptor subtype. The company is continuing to progress VK0214
through IND-enabling work, with a current goal of filing an IND in
2019 to allow initiation of a proof-of-concept study in X-ALD.
- Phase 2 study results of VK5211 in patients recovering from
hip fracture highlighted at ASBMR 2018 Annual Meeting. 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 the fourth quarter, Viking announced positive new
findings from the company's Phase 2 trial of VK5211 in patients
recovering from hip fracture during the plenary session of the
Annual Meeting of the American Society for Bone and Mineral
Research (ASBMR). In addition, the abstract received the 2018 Most
Outstanding Clinical Abstract Award from the conference organizers.
Among the notable results from this study was the observation that
patients receiving VK5211 gained weight, added muscle, and lost fat
content compared with patients receiving placebo. The company is
continuing to explore partnering and licensing opportunities that
will allow us to optimize the value of VK5211.
- Balance sheet sufficient to support operations through at
least 2021. In 2018, Viking raised approximately $315 million in gross proceeds through the
issuance of common stock, and completed 2018 with approximately
$302 million in cash, cash
equivalents, and short-term investments. The company currently
expects these resources to be sufficient to support operations
through at least the 2021 timeframe.
- Upcoming investor events. Viking management will
participate in the following March investor events:
31st Annual ROTH
Conference
Updated Time/Date: 12:00
p.m. PT on Monday, March 18, 2019 (webcast available)
Location: Ritz-Carlton Laguna Niguel, Dana Point, CA
Room: Pink – Salon 5
Oppenheimer's 29th
Annual Healthcare Conference
Time/Date: 11:30 a.m. ET on Wednesday, March 20, 2019
Location: Westin New York Grand Central Hotel, New York
Room: Consulate Room
Q4 and Full-Year 2018 Financial Highlights
Fourth Quarter Ended December 31,
2018 and 2017
Research and development expenses for the three months ended
December 31, 2018 were $5.1 million compared to $3.0 million for the same period in 2017.
The increase was primarily due to increased pre-clinical study
efforts, manufacturing expenses related to our drug candidates, use
of third party consultants and stock-based compensation, partially
offset by a decrease in clinical study expenses.
General and administrative expenses for the three months ended
December 31, 2018 were $1.9 million compared to $1.4 million for the same period in 2017.
The increase was primarily due to increased expenses related to
stock-based compensation, salaries and benefits, and legal and
patent expenses.
For the three months ended December 31,
2018, Viking reported a net loss of $5.2 million, or $0.07 per share, compared to a net loss of
$4.1 million, or $0.14 per share, in the corresponding period in
2017. The increase in net loss for the three months ended
December 31, 2018 was primarily due
to the increase in research and development 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 December 31, 2018 is primarily driven by the
additional shares outstanding at December
31, 2018 versus those outstanding at December 31, 2017, given the additional shares
issued by the Company during 2018, primarily through public equity
offerings.
Twelve Months Ended December 31,
2018 and 2017
Research and development expenses for the twelve months ended
December 31, 2018 were $19.0 million compared to $13.7 million for the same period in 2017.
The increase was primarily due to increased expenses related to
pre-clinical study efforts, use of third party consultants,
stock-based compensation, and manufacturing related to our drug
candidates, partially offset by a decrease in clinical study
expenses.
General and administrative expenses for the twelve months ended
December 31, 2018 were $7.1 million compared to $5.3 million for the same period in 2017.
The increase was primarily due to increased expenses related to
stock-based compensation, salaries and benefits, professional
services, use of third party consultants, insurance, legal and
patent expenses, and franchise taxes.
For the twelve months ended December 31,
2018, Viking reported a net loss of $22.1 million, or $0.38 per share, compared to a net loss of
$20.6 million, or $0.79 per share, in the corresponding period in
2017. The increase in net loss for the twelve months ended
December 31, 2018 was primarily due
to the increase in research and development expenses and general
and administrative expenses noted previously 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
twelve months ended December 31, 2018
is primarily driven by the additional shares outstanding at
December 31, 2018 versus those
outstanding at December 31, 2017,
given the additional shares issued by the Company during 2018,
primarily through public equity offerings.
Balance Sheet as of December 31,
2018
At December 31, 2018, Viking held
cash, cash equivalents and short-term investments totaling
$301.5 million. As of
February 28, 2019, Viking had
71,986,022 shares of common stock outstanding.
Conference Call
Management will host a conference call to discuss the company's
fourth quarter and year-end 2018 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 March 20, 2019 by dialing (877)
344-7529 from the U.S. or (412) 317-0088 from outside the U.S. and
entering conference ID # 10128574. 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, VK5211 and
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, VK5211, 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, 2017, and our next Annual Report on
Form 10-K 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.
Statements of
Operations and Comprehensive Loss
|
|
(In thousands,
except per share amounts)
|
(Unaudited)
|
|
|
Three Months Ended
December 31,
|
|
Year Ended
December 31,
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
Revenues
|
$
|
—
|
|
$
|
—
|
|
$
|
—
|
|
$
|
—
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
5,089
|
|
|
3,033
|
|
|
19,040
|
|
|
13,741
|
General and
administrative
|
|
1,948
|
|
|
1,394
|
|
|
7,121
|
|
|
5,329
|
Total operating
expenses
|
|
7,037
|
|
|
4,427
|
|
|
26,161
|
|
|
19,070
|
Loss from
operations
|
|
(7,037)
|
|
|
(4,427)
|
|
|
(26,161)
|
|
|
(19,070)
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value
of debt conversion feature liability
|
|
—
|
|
|
633
|
|
|
1,398
|
|
|
345
|
Amortization of debt
discount
|
|
—
|
|
|
(258)
|
|
|
(404)
|
|
|
(1,283)
|
Amortization of
financing costs
|
|
(30)
|
|
|
(34)
|
|
|
(120)
|
|
|
(571)
|
Interest income,
net
|
|
1,839
|
|
|
2
|
|
|
3,236
|
|
|
1
|
Realized loss on
investments
|
|
(12)
|
|
|
—
|
|
|
(12)
|
|
|
—
|
Total other income
(expense)
|
|
1,797
|
|
|
343
|
|
|
4,098
|
|
|
(1,508)
|
Net loss
|
|
(5,240)
|
|
|
(4,084)
|
|
|
(22,063)
|
|
|
(20,578)
|
Other comprehensive
loss, net of tax:
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized loss on
securities
|
|
(306)
|
|
|
(16)
|
|
|
(403)
|
|
|
(13)
|
Comprehensive
loss
|
$
|
(5,546)
|
|
$
|
(4,100)
|
|
$
|
(22,466)
|
|
$
|
(20,591)
|
Basic and diluted net
loss per share
|
$
|
(0.07)
|
|
$
|
(0.14)
|
|
$
|
(0.38)
|
|
$
|
(0.79)
|
Weighted-average
shares used to compute basic and
diluted net loss per share
|
|
71,340
|
|
|
29,872
|
|
|
57,580
|
|
|
25,978
|
Viking
Therapeutics, Inc.
|
Balance
Sheets
|
|
(In thousands,
except share and per share amounts)
|
|
|
December 31,
2018
(unaudited)
|
|
December 31,
2017
|
Assets
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
24,779
|
|
$
|
8,988
|
Short-term investments
– available for sale
|
|
276,741
|
|
|
11,587
|
Prepaid clinical trial
and preclinical study costs
|
|
335
|
|
|
887
|
Prepaid expenses and
other current assets
|
|
278
|
|
|
389
|
Total current
assets
|
|
302,133
|
|
|
21,851
|
Deferred public
offering and other financing costs
|
|
150
|
|
|
270
|
Deposits
|
|
29
|
|
|
—
|
Total
assets
|
$
|
302,312
|
|
$
|
22,121
|
Liabilities,
convertible notes and
stockholders' equity
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
Accounts
payable
|
$
|
959
|
|
$
|
1,529
|
Other accrued
liabilities
|
|
3,591
|
|
|
2,257
|
Accrued
interest
|
|
—
|
|
|
22
|
Convertible notes
payable, current portion (net of discount of $0 and $404 at
December 31, 2018 and 2017, respectively)
|
|
—
|
|
|
3,451
|
Debt conversion
feature liability
|
|
—
|
|
|
1,398
|
Total current
liabilities
|
|
4,550
|
|
|
8,657
|
Deferred
rent
|
|
12
|
|
|
—
|
Total long-term
liabilities
|
|
12
|
|
|
—
|
Total
liabilities
|
|
4,562
|
|
|
8,657
|
Commitments and
contingencies
|
|
|
|
|
|
Stockholders' equity:
|
|
|
|
|
|
Preferred stock,
$0.00001 par value: 10,000,000 shares authorized at December 31,
2018 and 2017; no shares issued and outstanding at December 31,
2018 and 2017
|
|
—
|
|
|
—
|
Common stock, $0.00001
par value: 300,000,000 shares authorized at December 31, 2018 and
2017; 71,742,043 shares issued and outstanding at December 31, 2018
and 35,817,104 shares issued and outstanding at December 31,
2017
|
|
1
|
|
|
—
|
Additional paid-in
capital
|
|
401,090
|
|
|
94,339
|
Accumulated
deficit
|
|
(102,918)
|
|
|
(80,855)
|
Accumulated other
comprehensive loss
|
|
(423)
|
|
|
(20)
|
Total
stockholders' equity
|
|
297,750
|
|
|
13,464
|
Total liabilities and
stockholders' equity
|
$
|
302,312
|
|
$
|
22,121
|
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SOURCE Viking Therapeutics, Inc.