SAN DIEGO, May 2, 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 first quarter ended March 31, 2019, and provided an update on its
clinical pipeline and other corporate developments.
Highlights from the Quarter, and Subsequent to March 31, 2019:
"The progress and momentum we achieved during 2018 have
continued into 2019," stated Brian
Lian, Ph.D., chief executive officer of Viking
Therapeutics. "At the recent EASL conference, we announced
positive new data from our Phase 2 trial of VK2809 in patients with
fatty liver disease and hypercholesterolemia demonstrating
impressive efficacy at doses as low as 5 mg daily. Even at
these lower exposures, VK2809 shows potent liver fat reduction and
improvements in plasma lipids that are on par with the previously
reported 10 mg doses. These data provide further evidence
that VK2809's unique liver-targeted mechanism may lead to enhanced
tissue exposures, allowing for greater flexibility in dosing.
In addition, VK2809's predictable PK, encouraging safety, and
excellent tolerability continue to indicate an exciting therapeutic
profile in the setting of NASH. The observed reduction in
LDL-C and other lipids also suggests potential cardiovascular
benefits, an important consideration in this patient
population. We remain on track to initiate a Phase
2b study of VK2809 in
biopsy-confirmed NASH later this year."
Pipeline and Corporate Highlights
- Positive VK2809 Phase 2 data presented at the Late-Breaker
poster session of the 2019 EASL conference. The company
recently announced additional data from the low-dose 5 mg cohort in
the Phase 2 trial of VK2809 in patients with non-alcoholic fatty
liver disease (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 a 50% relative reduction in liver fat, compared
with patients receiving 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 were presented at
the Late-Breaker poster session at the annual meeting of the
European Association for the Study of the Liver (EASL) in
Vienna, Austria. The company
expects to file an investigational new drug (IND) application for
VK2809 and initiate a Phase 2b study
in patients with biopsy-confirmed NASH in 2H19.
- Advancing IND-enabling work for VK0214 in X-linked
adrenoleukodystrophy (X-ALD); IND filing planned in
2H19. VK0214 is a novel, orally available small molecule
thyroid receptor agonist that possesses selectivity for the beta
receptor subtype. The company is evaluating VK0214 as a potential
treatment for X-ALD, a devastating disease caused by a defect in a
peroxisomal transporter called ABCD1. Data from in vitro and
in vivo studies have demonstrated that activation of the
thyroid beta receptor may stimulate the metabolism of very long
chain fatty acids, which are believed to contribute to the neuronal
toxicities observed in X-ALD patients. The company is continuing to
progress VK0214 through IND-enabling work with a goal of filing an
IND in 2H19 to allow initiation of a proof-of-concept study in
X-ALD.
- Balance sheet remains strong with approximately $300 million in cash and equivalents. Viking
completed the first quarter of 2019 with $298.7 million in cash, cash equivalents, and
short-term investments.
- Upcoming investor events. Viking management will
participate in the following May and June investor events:
SunTrust Robinson Humphrey
5th Annual Life Science Summit
Dates: May 7 – 8, 2019
Location: Lotte New York Palace, New
York, NY
B. Riley FBR Annual Investor
Conference
Dates: May 22 – 23, 2019
Location: Beverly Hilton, Beverly Hills,
CA
Jefferies 2019 Global
Healthcare Conference
Dates: June 4 – 7, 2019
Location: Grand Hyatt, New York,
NY
9th Annual LD Micro
Invitational
Dates: June 4 – 5, 2019
Location: Luxe Sunset Hotel, Bel Air,
CA
Raymond
James 2019 Life Sciences and MedTech Conference
Dates: June 18 – 19, 2019
Location: Lotte New York Palace, New
York, NY
Q1 2019 Financial Highlights
Research and development expenses for the three months ended
March 31, 2019 were $4.5 million compared to $3.0 million for the same period in 2018.
The increase was primarily due to increased manufacturing expenses
related to our drug candidates, pre-clinical study efforts, use of
third-party consultants, stock-based compensation and salaries and
benefits, partially offset by a decrease in clinical study
expenses.
General and administrative expenses for the three months ended
March 31, 2019 were $2.3 million compared to $1.8 million for the same period in 2018.
The increase was primarily due to increased expenses related to
stock-based compensation, salaries and benefits and use of
third-party consultants.
For the three months ended March 31,
2019, Viking reported a net loss of $4.9 million and a basic net loss per share of
$0.07, compared to a net loss of
$3.6 million and a basic net loss per
share of $0.08 in the corresponding
period in 2018. The increase in net loss for the three months
ended March 31, 2019 was primarily
due to the increase in research and development and general and
administrative expenses noted previously. This was partially offset
by an increase in interest income during the three months
ended March 31, 2019 and the
elimination of the change in the fair value of debt conversion
feature liability as well as amortization of debt discount due to
the Company's repayment of debt in May 2018. The decrease in
net loss per share for the three months ended March 31, 2019 is primarily due to the additional
shares outstanding at March 31, 2019
versus those outstanding at March 31,
2018, given the additional shares issued by the Company in
June and September 2018, through
public equity offerings.
Balance Sheet as of March 31,
2019
At March 31, 2019, Viking held
cash, cash equivalents and short-term investments totaling
$298.7 million. As of
April 30, 2019, Viking had 72,047,657
shares of common stock outstanding.
Conference Call
Management will host a conference call to discuss the company's
first 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
May 9, 2019 by dialing (877) 344-7529
from the U.S. or (412) 317-0088 from outside the U.S. and entering
conference ID # 10131006. 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 and its 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 VK5211 and VK2809; 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 March
31,
|
|
|
2019
|
|
|
2018
|
Revenues
|
|
$
|
—
|
|
|
$
|
—
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
|
|
4,496
|
|
|
|
3,043
|
General and
administrative
|
|
|
2,310
|
|
|
|
1,762
|
Total operating
expenses
|
|
|
6,806
|
|
|
|
4,805
|
Loss from
operations
|
|
|
(6,806)
|
|
|
|
(4,805)
|
Other income
(expense):
|
|
|
|
|
|
|
|
Change in fair value
of debt conversion feature liability
|
|
|
—
|
|
|
|
1,361
|
Amortization of debt
discount
|
|
|
—
|
|
|
|
(258)
|
Amortization of
financing costs
|
|
|
(30)
|
|
|
|
(30)
|
Interest income
(expense), net
|
|
|
1,914
|
|
|
|
181
|
Realized loss on
investments
|
|
|
(2)
|
|
|
|
—
|
Total other income
(expense), net
|
|
|
1,882
|
|
|
|
1,254
|
Net loss
|
|
|
(4,924)
|
|
|
|
(3,551)
|
Other comprehensive
loss, net of tax:
|
|
|
|
|
|
|
|
Unrealized gain (loss)
on securities
|
|
|
374
|
|
|
|
(89)
|
Comprehensive
loss
|
|
$
|
(4,550)
|
|
|
$
|
(3,640)
|
|
|
|
|
|
|
|
|
Net loss per common
share
|
|
|
|
|
|
|
|
Basic
|
|
$
|
(0.07)
|
|
|
$
|
(0.08)
|
Diluted
|
|
$
|
(0.07)
|
|
|
$
|
(0.10)
|
|
|
|
|
|
|
|
|
Weighted-average
shares used to compute net loss per share
|
|
|
|
|
|
|
|
Basic
|
|
|
71,755
|
|
|
|
44,649
|
Diluted
|
|
|
71,755
|
|
|
|
45,306
|
Viking
Therapeutics, Inc.
|
Balance
Sheets
|
(In thousands,
except share and per share amounts)
|
|
|
|
March 31, 2019
|
|
|
December 31, 2018
|
|
|
(Unaudited)
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
14,343
|
|
|
$
|
24,779
|
Short-term investments
– available for sale
|
|
|
284,375
|
|
|
|
276,741
|
Prepaid clinical trial
and preclinical study costs
|
|
|
168
|
|
|
|
335
|
Prepaid expenses and
other current assets
|
|
|
251
|
|
|
|
278
|
Total current
assets
|
|
|
299,137
|
|
|
|
302,133
|
Right-of-use
assets
|
|
|
794
|
|
|
|
—
|
Deferred public
offering and other financing costs
|
|
|
120
|
|
|
|
150
|
Deposits
|
|
|
29
|
|
|
|
29
|
Total
assets
|
|
$
|
300,080
|
|
|
$
|
302,312
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
1,676
|
|
|
$
|
959
|
Other accrued
liabilities
|
|
|
2,961
|
|
|
|
3,591
|
Lease liability,
current
|
|
|
281
|
|
|
|
—
|
Total current
liabilities
|
|
|
4,918
|
|
|
|
4,550
|
Deferred
rent
|
|
|
—
|
|
|
|
12
|
Lease liability, net
of current portion
|
|
|
588
|
|
|
|
—
|
Total long-term
liabilities
|
|
|
588
|
|
|
|
12
|
Total
liabilities
|
|
|
5,506
|
|
|
|
4,562
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
Stockholders' equity:
|
|
|
|
|
|
|
|
Preferred stock,
$0.00001 par value: 10,000,000 shares authorized at March 31, 2019
and December 31, 2018; no shares issued and outstanding at March
31, 2019 and December 31, 2018
|
|
|
—
|
|
|
|
—
|
Common stock, $0.00001
par value: 300,000,000 shares authorized at March 31, 2019 and
December 31, 2018; 72,027,657 and 71,742,043 shares issued and
outstanding at March 31, 2019 and December 31, 2018,
respectively
|
|
|
1
|
|
|
|
1
|
Additional paid-in
capital
|
|
|
402,464
|
|
|
|
401,090
|
Accumulated
deficit
|
|
|
(107,842)
|
|
|
|
(102,918)
|
Accumulated other
comprehensive loss
|
|
|
(49)
|
|
|
|
(423)
|
Total
stockholders' equity
|
|
|
294,574
|
|
|
|
297,750
|
Total liabilities and
stockholders' equity
|
|
$
|
300,080
|
|
|
$
|
302,312
|
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SOURCE Viking Therapeutics, Inc.