SAN DIEGO, July 29, 2020 /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 and six months ended
June 30, 2020, and provided an update
on its clinical pipeline and other corporate developments.
Highlights from the Quarter Ended June
30, 2020:
"During the second quarter, we continued enrolling our Phase
2b VOYAGE clinical trial evaluating
VK2809 in patients with biopsy-confirmed NASH and fibrosis," stated
Brian Lian, Ph.D., chief executive
officer of Viking Therapeutics. "Despite ongoing challenges
due to the pandemic, we are encouraged that sites continue to come
back online, and we remain on track to open ex-U.S. sites in the
coming months. We continue to anticipate completion of
enrollment in VOYAGE in the first half of next year. We have
also made excellent progress with our second thyroid hormone
receptor agonist, VK0214, for the treatment of X-linked
adrenoleukodystrophy, and recently filed an investigational new
drug application with the FDA to initiate the clinical development
of this important molecule. Pending IND clearance, we plan to
initiate a Phase 1 study with VK0214 later this quarter. As
we expand our clinical development activities, we continue to
carefully manage our cash resources. We are pleased to have
ended the quarter with $263 million
in cash, which provides the resources to achieve multiple
value-driving milestones for our clinical programs."
Pipeline and Corporate Highlights
- U.S. enrollment continuing in Phase 2b VOYAGE
study of VK2809 in biopsy-confirmed non-alcoholic steatohepatitis
(NASH) and fibrosis – ex-U.S. sites scheduled to open in Q3
2020. 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, and has
demonstrated promising therapeutic potential in a range of lipid
disorders, including NASH. In 2019, the company initiated the
Phase 2b VOYAGE trial. This
trial is a randomized, double-blind, placebo-controlled,
multicenter study designed to assess the efficacy, safety and
tolerability of VK2809 in patients with biopsy-confirmed NASH and
fibrosis ranging from stages F1 to F3. The study is targeting
enrollment of approximately 340 patients across five treatment
arms: 1.0 mg daily; 2.5 mg daily; 5.0 mg every other day; 10.0 mg
every other day; and placebo.
The primary endpoint of the study will evaluate the relative change
in liver fat content, as assessed by magnetic resonance imaging,
proton density fat fraction (MRI-PDFF) from baseline to Week 12 in
subjects treated with VK2809, as compared to placebo.
Secondary objectives include evaluation of histologic changes
assessed by hepatic biopsy after 52 weeks of dosing. U.S.
enrollment is continuing and we remain on schedule to begin opening
ex-U.S. sites during the third quarter of 2020.
- New data from VK2809 Phase 2 trial to be highlighted in
podium presentation at EASL. An abstract describing
additional data from the company's completed 12-week Phase 2 trial
of VK2809 in patients with non-alcoholic fatty liver disease
(NAFLD) and hypercholesterolemia has been selected for oral
presentation at the 2020 International Liver Congress, hosted by
the European Association for the Study of the Liver (EASL).
As a reminder, this study successfully achieved its primary and
secondary efficacy endpoints, demonstrating median relative
reductions in liver fat ranging from 53.8% to approximately 60%,
and response rates of up to 100%, both of which represent
unprecedented efficacy from an oral agent. Due to the
COVID-19 pandemic, the EASL conference was postponed from the
originally-scheduled April 15-19
dates until August 27-29, 2020, and
will take place virtually. The VK2809 Phase 2 data
presentation is scheduled for Friday, August
28th.
- IND filed for VK0214 for the treatment of X-ALD – expect to
initiate clinical development in Q3 2020. VK0214 is being
evaluated as a potential treatment for X-linked
adrenoleukodystrophy (X-ALD), a devastating disease for which there
is currently 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, findings 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 were achieved
through the company's ongoing collaboration with the Kennedy
Krieger Institute – one of the world's leading X-ALD research
centers. The company recently filed an Investigational New
Drug (IND) application for VK0214. Following clearance of the
IND, the company plans to initiate a Phase 1 study of VK0214 in the
third quarter of 2020.
- Balance sheet remains strong with over $260 million in cash. Viking
completed the second quarter of 2020 with $263 million in
cash, cash equivalents and short-term investments.
- Upcoming investor events. Viking management will
participate in the following upcoming investor events:
William Blair Virtual Biotech
Focus Conference 2020
Dates: August 4 - 6,
2020
Virtual Format
BTIG Virtual Biotechnology
Conference 2020
Dates: August 10 - 11, 2020
Virtual Format
Citi's 15th Annual
BioPharma Virtual Conference
Dates: September 9 - 10,
2020
Virtual Format
Morgan Stanley Virtual
18th Annual Global Healthcare
Conference
Dates: September 14 - 18, 2020
Virtual Format
Cantor Global Virtual
Healthcare Conference
Dates: September 15 - 17,
2020
Virtual Format
Oppenheimer Fall Healthcare
Life Sciences & Med Tech Summit
Dates: September
21-23, 2020
Virtual Format
Second Quarter and First Six Months of 2020 Financial
Highlights
Second Quarter Ended June 30,
2020 and 2019
Research and development expenses for the three months ended
June 30, 2020 were $7.8 million compared to $7.3 million for the same period in 2019.
The increase was primarily due to increased expenses related to our
clinical studies, manufacturing for our drug candidates, salaries
and benefits and stock-based compensation, partially offset by
decreased expenses related to pre-clinical studies and services
provided by third-party consultants.
General and administrative expenses for the three months ended
June 30, 2020 were $2.8 million compared to $2.2 million for the same period in 2019.
The increase was primarily due to increased expenses related to
stock-based compensation, legal expenses and insurance expenses,
partially offset by decreased expenses related to services provided
by third-party consultants and travel.
For the three months ended June 30,
2020, Viking reported a net loss of $9.6 million, or $0.13 per share, compared to a net loss of
$7.7 million, or $0.11 per share, in the corresponding period in
2019. The increase in net loss and net loss per share for the
three months ended June 30, 2020 was
primarily due to the increases in research and development and
general and administrative expenses noted previously, as well as
decreased interest income due to the decline in interest rates
throughout the second quarter of 2020 as compared to prevailing
interest rates during the second quarter of 2019.
First Six Months Ended June 30,
2020 and 2019
Research and development expenses for the six months ended
June 30, 2020 were $15.8 million compared to $11.8 million for the same period in 2019.
The increase was primarily due to increased expenses related to our
clinical studies, manufacturing for our drug candidates, salaries
and benefits and stock-based compensation, partially offset by
decreased expenses related to services provided by third-party
consultants and pre-clinical studies.
General and administrative expenses for the six months ended
June 30, 2020 were $5.8 million compared to $4.5 million for the same period in 2019.
The increase was primarily due to increased expenses related to
stock-based compensation, legal expenses and insurance expenses,
partially offset by decreased expenses related to services provided
by third-party consultants, professional fees and travel.
For the six months ended June 30,
2020, Viking reported a net loss of $19.3 million, or $0.27 per share, compared to a net loss of
$12.6 million, or $0.18 per share, in the corresponding period in
2019. The increase in net loss and net loss per share for the
six months ended June 30, 2020 was
primarily due to the increases in research and development and
general and administrative expenses noted previously, as well as
decreased interest income due to the decline in interest rates
throughout the first half of 2020 as compared to prevailing
interest rates during the first half of 2019.
Balance Sheet as of June 30,
2020
At June 30, 2020, Viking held
cash, cash equivalents and short-term investments totaling
$263.0 million and had 72,758,342
shares of common stock outstanding.
Conference Call
Management will host a conference call to discuss the company's
second quarter 2020 financial results today at 4:30 pm Eastern. To participate in 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 5, 2020 by dialing (877)
344-7529 from the U.S. or (412) 317-0088 from outside the U.S. and
entering conference ID # 10145659. Those interested in
listening to the conference call live via the internet may do so by
visiting the Webcasts page of Viking's website at
http://ir.vikingtherapeutics.com/webcasts. An archive of the
webcast will also be available on the Webcasts page of the
company's website for 30 days.
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, which is currently being evaluated in a
Phase 2b study for the treatment of biopsy-confirmed
non-alcoholic steatohepatitis (NASH) and fibrosis. 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.
For more information about Viking Therapeutics, please visit
www.vikingtherapeutics.com. 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, including the
company's expected timing for the initiation of clinical studies in
X-ALD for VK0214 and plans for opening sites outside the U.S. in
the company's VOYAGE Phase 2b study,
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 VK2809 and
VK0214; risks that prior clinical and preclinical results may not
be replicated; risks regarding regulatory requirements; risks
related to the COVID-19 pandemic; 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, 2019, 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,
|
|
|
|
2020
|
|
|
2019
|
|
|
2020
|
|
|
2019
|
|
Revenues
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
7,780
|
|
|
|
7,333
|
|
|
|
15,766
|
|
|
|
11,828
|
|
General and
administrative
|
|
|
2,826
|
|
|
|
2,236
|
|
|
|
5,787
|
|
|
|
4,547
|
|
Total operating
expenses
|
|
|
10,606
|
|
|
|
9,569
|
|
|
|
21,553
|
|
|
|
16,375
|
|
Loss from
operations
|
|
|
(10,606)
|
|
|
|
(9,569)
|
|
|
|
(21,553)
|
|
|
|
(16,375)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of
financing costs
|
|
|
(20)
|
|
|
|
(30)
|
|
|
|
(65)
|
|
|
|
(60)
|
|
Interest income,
net
|
|
|
1,040
|
|
|
|
1,925
|
|
|
|
2,344
|
|
|
|
3,839
|
|
Realized gain (loss)
on investments, net
|
|
|
14
|
|
|
|
—
|
|
|
|
15
|
|
|
|
(2)
|
|
Total other income,
net
|
|
|
1,034
|
|
|
|
1,895
|
|
|
|
2,294
|
|
|
|
3,777
|
|
Net loss
|
|
|
(9,572)
|
|
|
|
(7,674)
|
|
|
|
(19,259)
|
|
|
|
(12,598)
|
|
Other comprehensive
loss, net of tax:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain on
securities
|
|
|
1,145
|
|
|
|
288
|
|
|
|
321
|
|
|
|
662
|
|
Comprehensive
loss
|
|
$
|
(8,427)
|
|
|
$
|
(7,386)
|
|
|
$
|
(18,938)
|
|
|
$
|
(11,936)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
|
$
|
(0.13)
|
|
|
$
|
(0.11)
|
|
|
$
|
(0.27)
|
|
|
$
|
(0.18)
|
|
Weighted-average
shares used to compute basic and
diluted net loss per share
|
|
|
72,487
|
|
|
|
71,921
|
|
|
|
72,422
|
|
|
|
71,839
|
|
Viking
Therapeutics, Inc. Balance Sheets
|
|
(In thousands,
except share and per share amounts)
|
|
|
|
June 30,
2020
|
|
|
December 31,
2019
|
|
|
|
(Unaudited)
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
18,790
|
|
|
$
|
8,377
|
|
Short-term investments
– available for sale
|
|
|
244,212
|
|
|
|
267,261
|
|
Prepaid clinical trial
and preclinical study costs
|
|
|
6,702
|
|
|
|
7,458
|
|
Prepaid expenses and
other current assets
|
|
|
914
|
|
|
|
405
|
|
Total current
assets
|
|
|
270,618
|
|
|
|
283,501
|
|
Right-of-use
assets
|
|
|
462
|
|
|
|
598
|
|
Deferred public
offering and other financing costs
|
|
|
89
|
|
|
|
128
|
|
Deposits
|
|
|
29
|
|
|
|
29
|
|
Total
assets
|
|
$
|
271,198
|
|
|
$
|
284,256
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
3,209
|
|
|
$
|
2,431
|
|
Other accrued
liabilities
|
|
|
5,528
|
|
|
|
4,044
|
|
Lease liability,
current
|
|
|
316
|
|
|
|
302
|
|
Total current
liabilities
|
|
|
9,053
|
|
|
|
6,777
|
|
Lease liability, net
of current portion
|
|
|
198
|
|
|
|
360
|
|
Total long-term
liabilities
|
|
|
198
|
|
|
|
360
|
|
Total
liabilities
|
|
|
9,251
|
|
|
|
7,137
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
Preferred stock,
$0.00001 par value: 10,000,000 shares authorized
at June 30, 2020 and December 31, 2019; no shares issued and
outstanding at June 30, 2020 and December 31, 2019
|
|
|
—
|
|
|
|
—
|
|
Common stock, $0.00001
par value: 300,000,000 shares authorized
at June 30, 2020 and December 31, 2019; 72,758,342, and
72,413,602
shares issued and outstanding at June 30, 2020 and December 31,
2019, respectively
|
|
|
1
|
|
|
|
1
|
|
Additional paid-in
capital
|
|
|
409,569
|
|
|
|
405,803
|
|
Accumulated
deficit
|
|
|
(147,956)
|
|
|
|
(128,697)
|
|
Accumulated other
comprehensive income
|
|
|
333
|
|
|
|
12
|
|
Total stockholders'
equity
|
|
|
261,947
|
|
|
|
277,119
|
|
Total liabilities and
stockholders' equity
|
|
$
|
271,198
|
|
|
$
|
284,256
|
|
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SOURCE Viking Therapeutics, Inc.