SAN DIEGO, Aug. 9, 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 second quarter ended June 30,
2018, and provided an update on its clinical pipeline and
other corporate developments.
Highlights from, and Subsequent to, the Quarter Ended
June 30, 2018
"Viking continued to make excellent progress with multiple
programs in the second quarter," stated Brian Lian, Ph.D., chief executive officer of
Viking Therapeutics. "With respect to VK5211, our novel
selective androgen receptor modulator (SARM), we are honored to
have an opportunity to present the results of our Phase 2 study in
hip fracture patients at the plenary session of the upcoming
conference of the American Society for Bone and Mineral
Research. We are also very pleased to have completed
enrollment in the Phase 2 trial of our novel thyroid receptor beta
agonist VK2809 in patients with non-alcoholic fatty liver disease
(NAFLD) and elevated LDL cholesterol. We look forward to
reporting the results from this study in the fall. Finally,
both of our rare disease programs continued to advance toward
clinical development. With respect to our glycogen storage
disease (GSD) Ia program, we expect to initiate dosing with VK2809
in a proof-of-concept study later this quarter. And, with
respect to our VK0214 program in X-linked adrenoleukodystrophy
(X-ALD), we are conducting the pre-IND work that should allow us to
initiate a proof-of-concept trial in 2019."
Pipeline and Corporate Highlights
- VK5211 Phase 2 study results selected for plenary
presentation at ASBMR annual meeting. VK5211 is an orally
available, non-steroidal SARM designed to selectively stimulate
muscle and bone formation with reduced activity in peripheral
tissues such as skin and prostate. In July
2018, the American Society for Bone and Mineral Research
(ASBMR) selected the results of the company's Phase 2 study of
VK5211 in hip fracture for presentation as part of the oral plenary
session at the ASBMR 2018 annual meeting. The presentation,
scheduled for September 30, will
highlight the efficacy, safety and tolerability data from the
completed Phase 2 clinical trial. The ASBMR 2018 annual meeting is
being held September 28 –
October 1, 2018 in Montreal, Quebec, Canada.
- Enrollment completed in Phase 2 clinical trial of VK2809 in
NAFLD and hypercholesterolemia. 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 certain metabolic and liver diseases. During
the second quarter, enrollment was completed in the company's
ongoing Phase 2 study, which is evaluating VK2809 in patients with
NAFLD and elevated LDL cholesterol. Patients have been 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. The company
expects to announce results from this study in the second half of
2018.
- First patient dosing planned for proof of concept study of
VK2809 in GSD Ia. GSD Ia is a rare 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. 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 third
quarter of 2018.
- IND-enabling work for VK0214 in X-ALD advancing, 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 has initiated IND-enabling
work for this program and plans to file an IND to conduct a
proof-of-concept study in X-ALD in 2019.
- Balance sheet strengthened through $78 million equity financing. In the second
quarter of 2018, Viking raised approximately $78 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. As of June 30,
2018, the company had $142.2
million in cash, cash equivalents and short-term
investments.
Financial Highlights
Second Quarter Ended June 30,
2018 and 2017
Research and development expenses for the three months ended
June 30, 2018 were $5.2 million compared to $3.7 million for the same period in 2017.
The increase was primarily due to increased expenses related to
certain pre-clinical study efforts, use of third party consultants
and stock-based compensation, partially offset by decreased
manufacturing activities for certain of our drug
candidates.
General and administrative expenses for the three months ended
June 30, 2018 were $1.7 million compared to $1.3 million for the same period in 2017.
The increase was primarily due to increased expenses related to
stock-based compensation, salaries and benefits, and franchise
taxes.
For the three months ended June 30,
2018, Viking reported a net loss of $6.7 million, or $0.13 per share, compared to a net loss of
$5.2 million, or $0.21 per share, in the corresponding period in
2017. The increase in net loss for the three months ended
June 30, 2018 was primarily due to
the increase in research and development expenses noted
previously.
Six Months Ended June 30, 2018
and 2017
Research and development expenses for the six months ended
June 30, 2018 were $8.3 million compared to $7.2 million for the same period in 2017.
The increase was primarily due to increased expenses related
to certain pre-clinical study efforts, use of third party
consultants and stock-based compensation, partially offset by a
decrease in manufacturing of certain drug candidates and clinical
trial activities related to our VK5211 program.
General and administrative expenses for the six months ended
June 30, 2018 were $3.5 million compared to $2.7 million for the same period in 2017.
The increase was primarily due to increased expenses related to
stock-based compensation, salaries and benefits, legal, and
franchise taxes.
For the six months ended June 30,
2018, Viking reported a net loss of $10.2 million, or $0.21 per share, compared to a net loss of
$10.4 million, or $0.45 per share, in the corresponding period in
2017. The net loss for the six months ended June 30, 2018 was consistent with the net loss in
the corresponding period in 2017 primarily due to the increase in
research and development expenses noted previously offset by an
increase in other income related to the decrease in the fair value
of the debt conversion feature liability.
Balance Sheet as of June 30,
2018
At June 30, 2018, Viking held
cash, cash equivalents and short-term investments totaling
$142.2 million. As of
July 31, 2018, Viking had 60,657,794
shares of common stock outstanding.
Conference Call
Management will host a conference call to discuss the company's
second 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
August 16, 2018 by dialing (877)
344-7529 from the U.S. or (412) 317-0088 from outside the U.S. and
entering conference ID # 10122508. 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. The
company's clinical 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 to patients who received
placebo. The company's second clinical program is evaluating
VK2809, a small molecule thyroid beta agonist in a Phase 2 trial
for the treatment of non-alcoholic fatty liver disease and
hypercholesterolemia. The company is also developing VK0612,
a first-in-class, orally available drug candidate in Phase 2
development for type 2 diabetes. Additional programs include
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. Viking holds exclusive worldwide rights to
a portfolio of five therapeutic programs in clinical trials or
preclinical studies, 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 VK5211, VK2809 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 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, 2017, 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,
|
|
|
|
2018
|
|
|
2017
|
|
|
2018
|
|
|
2017
|
|
Revenues
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
5,221
|
|
|
|
3,716
|
|
|
|
8,264
|
|
|
|
7,243
|
|
General and
administrative
|
|
|
1,704
|
|
|
|
1,267
|
|
|
|
3,466
|
|
|
|
2,708
|
|
Total operating
expenses
|
|
|
6,925
|
|
|
|
4,983
|
|
|
|
11,730
|
|
|
|
9,951
|
|
Loss from
operations
|
|
|
(6,925)
|
|
|
|
(4,983)
|
|
|
|
(11,730)
|
|
|
|
(9,951)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value
of debt conversion feature liability
|
|
|
37
|
|
|
|
571
|
|
|
|
1,398
|
|
|
|
848
|
|
Amortization of debt
discount
|
|
|
(146)
|
|
|
|
(337)
|
|
|
|
(404)
|
|
|
|
(768)
|
|
Amortization of
financing costs
|
|
|
(30)
|
|
|
|
(422)
|
|
|
|
(60)
|
|
|
|
(520)
|
|
Interest income
(expense), net
|
|
|
392
|
|
|
|
(1)
|
|
|
|
573
|
|
|
|
(3)
|
|
Total other income
(expense), net
|
|
|
253
|
|
|
|
(189)
|
|
|
|
1,507
|
|
|
|
(443)
|
|
Net loss
|
|
|
(6,672)
|
|
|
|
(5,172)
|
|
|
|
(10,223)
|
|
|
|
(10,394)
|
|
Other comprehensive
loss, net of tax:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized (loss) gain
on securities
|
|
|
(38)
|
|
|
|
2
|
|
|
|
(127)
|
|
|
|
1
|
|
Comprehensive
loss
|
|
$
|
(6,710)
|
|
|
$
|
(5,170)
|
|
|
$
|
(10,350)
|
|
|
$
|
(10,393)
|
|
Basic and diluted net
loss per common share
|
|
$
|
(0.13)
|
|
|
$
|
(0.21)
|
|
|
$
|
(0.21)
|
|
|
$
|
(0.45)
|
|
Weighted-average
shares used to compute basic and diluted net loss per
share
|
|
|
52,767
|
|
|
|
24,119
|
|
|
|
48,730
|
|
|
|
23,241
|
|
Viking
Therapeutics, Inc. Balance Sheets
|
|
(In thousands,
except share and per share amounts)
|
|
|
|
June 30,
2018
|
|
|
December 31,
2017
|
|
|
|
(Unaudited)
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
34,610
|
|
|
$
|
8,988
|
|
Short-term investments
– available for sale
|
|
|
107,556
|
|
|
|
11,587
|
|
Prepaid clinical trial
and preclinical study costs
|
|
|
1,499
|
|
|
|
887
|
|
Prepaid expenses and
other current assets
|
|
|
593
|
|
|
|
389
|
|
Total current
assets
|
|
|
144,258
|
|
|
|
21,851
|
|
Deferred public
offering and other financing costs
|
|
|
210
|
|
|
|
270
|
|
Total
assets
|
|
$
|
144,468
|
|
|
$
|
22,121
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
1,493
|
|
|
$
|
1,529
|
|
Other accrued
liabilities
|
|
|
2,612
|
|
|
|
2,257
|
|
Accrued interest,
current
|
|
|
—
|
|
|
|
22
|
|
Convertible notes
payable, current (net of discount of $0 and $404 at June 30, 2018
and December 31, 2017, respectively)
|
|
|
—
|
|
|
|
3,451
|
|
Debt conversion
feature liability, current
|
|
|
—
|
|
|
|
1,398
|
|
Total current
liabilities
|
|
|
4,105
|
|
|
|
8,657
|
|
Total
liabilities
|
|
|
4,105
|
|
|
|
8,657
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
Preferred stock,
$0.00001 par value: 10,000,000 shares authorized at June 30, 2018
and December 31, 2017; no shares issued and outstanding at June 30,
2018 and December 31, 2017
|
|
|
—
|
|
|
|
—
|
|
Common stock, $0.00001
par value: 300,000,000 shares authorized at June 30, 2018 and
December 31, 2017; 60,652,794 and 35,817,104 shares issued and
outstanding at June 30, 2018 and December 31, 2017,
respectively
|
|
|
1
|
|
|
|
—
|
|
Additional paid-in
capital
|
|
|
231,587
|
|
|
|
94,339
|
|
Accumulated
deficit
|
|
|
(91,078)
|
|
|
|
(80,855)
|
|
Accumulated other
comprehensive loss
|
|
|
(147)
|
|
|
|
(20)
|
|
Total stockholders'
equity
|
|
|
140,363
|
|
|
|
13,464
|
|
Total liabilities and
stockholders' equity
|
|
$
|
144,468
|
|
|
$
|
22,121
|
|
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SOURCE Viking Therapeutics, Inc.