SAN DIEGO, April 28, 2021 /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, 2021, and provided an update on its
clinical pipeline and other corporate developments.
Highlights from the Quarter Ended March 31, 2021:
"During the first quarter of 2021, we continued to build on the
significant progress made during 2020 with both of our thyroid
hormone beta receptor agonist programs," stated Brian Lian, Ph.D., chief executive officer of
Viking. "We continue to enroll patients in our 52-week Phase
2b VOYAGE trial evaluating VK2809 in
NASH and fibrosis, and expect to complete enrollment in the second
half of 2021. With respect to our second thyroid hormone beta
receptor agonist program, VK0214, we are nearing completion of a
Phase 1 single ascending and multiple ascending dose study in
healthy volunteers. Pending the results, we expect to
initiate a Phase 1b study of VK0214
in X-ALD patients this summer. On the corporate side, our
balance sheet remains solid, and we ended the first quarter with
approximately $242 million in cash,
providing ample runway to achieve important milestones with each of
our clinical programs."
Pipeline and Corporate Highlights
- Enrollment continues in Phase 2b VOYAGE study evaluating VK2809 for the
treatment of NASH. 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 non-alcoholic steatohepatitis (NASH). Phase 1
studies in healthy volunteers as well as in subjects with mild
hypercholesterolemia have shown that treatment with VK2809 produces
significant reductions in plasma lipids, including LDL-cholesterol,
triglycerides, and atherogenic proteins. A prior 12 week Phase 2a
study in patients with non-alcoholic fatty liver disease and
hypercholesterolemia successfully achieved its primary and
secondary endpoints, with VK2809-treated patients demonstrating
significant reductions in plasma lipids, and median relative
reductions in liver fat of up to approximately 60%. In addition,
approximately 88% of VK2809-treated patients in this study
experienced relative reductions in liver fat content of ≥30%.
The company's ongoing Phase 2b VOYAGE
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.
During the first quarter of 2021, enrollment in VOYAGE continued at
sites in both the U.S. and Europe. The company currently
remains on track to complete enrollment in this trial in the second
half of 2021.
- Phase 1 study evaluating VK0214 in healthy volunteers
ongoing; Phase 1b study in X-ALD to
begin mid-2021. VK0214 is a novel, orally available
thyroid hormone receptor beta agonist being evaluated as a
potential treatment for X-linked adrenoleukodystrophy (X-ALD), a
rare neurodegenerative disease for which there is currently no
pharmacologic treatment option. 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, key
biomarkers of disease, in both plasma and tissue, suggesting a
potential therapeutic benefit.
In 2020, the company initiated a Phase 1 first-in-human clinical
trial of VK0214. This trial is a randomized,
double-blind, placebo-controlled, single ascending dose (SAD) and
multiple ascending dose (MAD) study in healthy subjects. The
primary objective of the study is to evaluate the safety,
tolerability, and pharmacokinetics of single and multiple oral
doses of VK0214. The results will also inform potential
dosing levels for a planned Phase 1b
study in patients with X-ALD. At present, dosing in healthy
volunteers is nearing completion and, pending a review of the
results, the company expects to initiate the Phase 1b trial mid-year.
- Strong balance sheet provides runway to complete multiple
key clinical milestones. Viking completed the first
quarter of 2021 with $241.7 million in cash, cash
equivalents and short-term investments.
- Upcoming investor events. Viking management will
participate in the following upcoming investor events, all of which
will be virtual:
7th Annual Truist
Securities Life Sciences Summit
Dates: May 4 - 5,
2021
SVB Leerink CybeRx Series:
Liver Disease Day
Date: June 17, 2021
Raymond James Human Health
Innovations Conference
Dates: June 21 - 23, 2021
Q1 2021 Financial Highlights
Research and development expenses for the three months ended
March 31, 2021 were $11.5 million compared to $8.0 million for the same period in 2020.
The increase was primarily due to increased expenses related to
clinical studies, manufacturing for the company's drug candidates,
salaries and benefits and stock-based compensation, partially
offset by decreased expenses related to pre-clinical studies.
General and administrative expenses for the three months ended
March 31, 2021 were $2.7 million compared to $3.0 million for the same period in 2020.
The decrease was primarily due to decreased expenses related to
stock-based compensation, legal and patent services, salaries and
benefits and travel, partially offset by increased expenses related
to professional fees and insurance.
For the three months ended March 31,
2021, Viking reported a net loss of $14.0 million, or $0.19 per share, compared to a net loss of
$9.7 million, or $0.13 per share, in the corresponding period in
2020. The increase in net loss and net loss per share for the
three months ended March 31, 2021 was
primarily due to an increase in research and development expenses,
partially offset by a decrease in general and administrative
expenses, as noted previously, as well as decreased interest income
primarily due to the decline in interest rates available throughout
the first quarter of 2021 as compared to prevailing interest rates
during the first quarter of 2020.
Balance Sheet as of March 31,
2021
At March 31, 2021, Viking held
cash, cash equivalents and short-term investments of $241.7 million, compared to $248.4 million as of December 31, 2020.
Conference Call
Management will host a conference call to discuss the company's
first quarter 2021 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
May 5, 2021 by dialing (877) 344-7529
from the U.S. or (412) 317-0088 from outside the U.S. and entering
conference ID #10153769. 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 potential treatment of X-linked
adrenoleukodystrophy (X-ALD). VK0214 is currently being
evaluated in a Phase 1 first-in-human clinical trial. 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 potential initiation and
completion of clinical studies in X-ALD for VK0214 and plans for
completion of the company's VOYAGE Phase 2b study, as well as the company's goals and
plans regarding VK0214, VK2809 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; 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, 2020, 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,
|
|
|
|
2021
|
|
|
2020
|
|
Revenues
|
|
$
|
—
|
|
|
$
|
—
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
11,535
|
|
|
|
7,987
|
|
General and
administrative
|
|
|
2,693
|
|
|
|
2,961
|
|
Total operating
expenses
|
|
|
14,228
|
|
|
|
10,948
|
|
Loss from
operations
|
|
|
(14,228)
|
|
|
|
(10,948)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Amortization of
financing costs
|
|
|
(21)
|
|
|
|
(45)
|
|
Interest income,
net
|
|
|
239
|
|
|
|
1,304
|
|
Realized gain on
investments, net
|
|
|
—
|
|
|
|
2
|
|
Total other income,
net
|
|
|
218
|
|
|
|
1,261
|
|
Net loss
|
|
|
(14,010)
|
|
|
|
(9,687)
|
|
Other comprehensive
loss, net of tax:
|
|
|
|
|
|
|
|
|
Unrealized loss on
securities
|
|
|
(50)
|
|
|
|
(824)
|
|
Comprehensive
loss
|
|
$
|
(14,060)
|
|
|
$
|
(10,511)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
|
$
|
(0.19)
|
|
|
$
|
(0.13)
|
|
Weighted-average
shares used to compute basic and diluted net loss per
share
|
|
|
74,782
|
|
|
|
72,356
|
|
Viking
Therapeutics, Inc.
Balance
Sheets
(In thousands,
except share and per share amounts)
|
|
|
|
March 31,
2021
|
|
|
December 31,
2020
|
|
|
|
(Unaudited)
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
16,805
|
|
|
$
|
29,117
|
|
Short-term investments
– available for sale
|
|
|
224,874
|
|
|
|
219,269
|
|
Prepaid clinical trial
and preclinical study costs
|
|
|
7,559
|
|
|
|
7,276
|
|
Prepaid expenses and
other current assets
|
|
|
625
|
|
|
|
442
|
|
Total current
assets
|
|
|
249,863
|
|
|
|
256,104
|
|
Right-of-use
assets
|
|
|
249
|
|
|
|
321
|
|
Deferred financing
costs
|
|
|
27
|
|
|
|
48
|
|
Deposits
|
|
|
—
|
|
|
|
29
|
|
Total
assets
|
|
$
|
250,139
|
|
|
$
|
256,502
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
4,848
|
|
|
$
|
3,988
|
|
Other accrued
liabilities
|
|
|
7,789
|
|
|
|
7,811
|
|
Lease liability,
current
|
|
|
279
|
|
|
|
330
|
|
Total current
liabilities
|
|
|
12,916
|
|
|
|
12,129
|
|
Lease liability, net
of current portion
|
|
|
—
|
|
|
|
29
|
|
Total long-term
liabilities
|
|
|
—
|
|
|
|
29
|
|
Total
liabilities
|
|
|
12,916
|
|
|
|
12,158
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
Preferred stock,
$0.00001 par value: 10,000,000 shares authorized
at March 31, 2021 and December 31, 2020; no shares issued and
outstanding at March 31, 2021 and December 31, 2020
|
|
|
—
|
|
|
|
—
|
|
Common stock, $0.00001
par value: 300,000,000 shares authorized
at March 31, 2021 and December 31, 2020; 77,178,081 and
73,215,940 shares issued and outstanding at March 31, 2021 and
December 31, 2020, respectively
|
|
|
1
|
|
|
|
1
|
|
Additional paid-in
capital
|
|
|
419,528
|
|
|
|
412,589
|
|
Accumulated
deficit
|
|
|
(182,202)
|
|
|
|
(168,192)
|
|
Accumulated other
comprehensive loss
|
|
|
(104)
|
|
|
|
(54)
|
|
Total stockholders'
equity
|
|
|
237,223
|
|
|
|
244,344
|
|
Total liabilities and
stockholders' equity
|
|
$
|
250,139
|
|
|
$
|
256,502
|
|
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SOURCE Viking Therapeutics, Inc.