SAN DIEGO, Oct. 28, 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 third quarter and nine months ended
September 30, 2020, and provided an
update on its clinical pipeline and other corporate
developments.
Highlights from the Quarter Ended September 30, 2020:
"The third quarter at Viking was highlighted by continued
pipeline progress, with enrollment now ongoing in two important
clinical programs," stated Brian
Lian, Ph.D., chief executive officer of Viking
Therapeutics. "The Phase 2b
VOYAGE study of our lead NASH program, VK2809, continues and we
anticipate completion of enrollment in the first half of
2021. In addition, at the EASL conference in August, we
presented new data from the prior 12-week study of VK2809,
demonstrating consistent liver fat reductions across high risk
subgroups, as well as durable efficacy maintained four weeks after
completion of dosing. With respect to our VK0214 program for
X-linked adrenoleukodystrophy, we are excited to have moved this
important program into the clinic, with the announcement of a Phase
1 SAD/MAD study in healthy subjects. Pending successful
completion, in 2021 we plan to initiate a Phase 1b study
in patients with X-ALD. Both of these clinical trials
continue to advance despite disruptions resulting from the COVID-19
pandemic. Finally, to support both of these programs, we
continue to judiciously manage our balance sheet and ended the
quarter with $255 million in
cash."
Pipeline and Corporate Highlights
- Phase 2b VOYAGE study of
VK2809 in biopsy-confirmed non-alcoholic steatohepatitis (NASH) and
fibrosis continues. 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. 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.
Despite disruption from the coronavirus pandemic, the majority of
our U.S. clinical sites are open for enrollment. The company plans
to expand the number of clinical sites over the next few months to
include over 80 U.S. clinical sites and more than 90 sites
globally. The company anticipates completion of enrollment in the
first half of 2021.
- New data from VK2809 Phase 2 trial highlighted during podium
presentation at EASL 2020. New data from the company's prior
12-week Phase 2 study evaluating VK2809 in the treatment of
non-alcoholic fatty liver disease and hypercholesterolemia were
highlighted during an oral presentation at the 2020 EASL meeting.
The newly reported data demonstrated that patients treated with
VK2809 experienced highly durable, statistically significant
reductions in liver fat content that were maintained at Week 16,
four weeks after completion of dosing in the 12-week study. The
results showed that among VK2809-treated patients, the median
reduction in liver fat content was 45.4% at Week 16, compared to an
18.7% reduction for placebo (p=0.0053). Additionally, at Week 16,
70.4% of all VK2809-treated patients maintained a response, defined
as experiencing ≥ 30% relative reduction from baseline in liver fat
content (p=0.0083). Of note, 100% of patients receiving 5 mg daily
doses of VK2809 maintained a response at Week 16.
Additionally, new analyses of Week 12 study results demonstrated
significant reductions in liver fat content among patients
receiving VK2809 as compared to placebo regardless of the presence
of common risk factors for NASH, including baseline levels of
alanine aminotransferase (ALT) above the upper limit of normal (ALT
> xULN), body mass index (BMI) ≥ 30, hypertension and Hispanic
ethnicity.
The overall results from this study, including these new durability
data, as well as the observed consistent efficacy across high risk
subgroups, provide strong rationale for further development of
VK2809 in the setting of NASH, and may indicate opportunities for
multiple dosing strategies, including chronic, intermittent, or the
potential cycling of treatment modalities.
- Initiated Phase 1 trial evaluating VK0214 for the treatment
of X-ALD. VK0214 is a novel, orally available thyroid receptor
beta agonist being evaluated as a potential treatment for X-linked
adrenoleukodystrophy (X-ALD), a devastating disease for which there
is currently no therapeutic treatment. 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, key biomarkers of
disease, suggesting a potential therapeutic benefit.
During the third quarter, the company advanced this program into
clinical development by initiating a Phase 1 first-in-human trial.
The Phase 1 trial is a randomized, double-blind,
placebo-controlled, single ascending dose (SAD) and multiple
ascending dose (MAD) study in healthy subjects. The primary
objectives of the study include evaluation of the safety,
tolerability, and pharmacokinetics of single and multiple oral
doses of VK0214, as well as the identification of VK0214 doses for
further clinical development in the setting of X-ALD. Upon
successful completion of the SAD/MAD study, the company plans in
2021 to advance this program into a proof-of-concept trial in
patients with X-ALD.
- Balance sheet remains strong with over $255 million in cash. Viking completed the
third quarter of 2020 with $255.3
million in cash, cash equivalents and short-term
investments.
- Upcoming investor events. Viking management will
participate in the following upcoming investor events:
Stifel 2020 Healthcare
Conference
Dates: November 16 - 18, 2020
Virtual Format
H.C. Wainwright BIOCONNECT 2021
Conference
Dates: January 11 - 14, 2021
Virtual Format
10th Annual SVB
Leerink Global Healthcare Conference
Dates: February 23
- 25, 2021
Format TBD
Raymond
James 2021 Institutional Investors
Conference
Dates: March 1 - 3, 2021
Virtual Format
Third Quarter and First Nine Months of 2020 Financial
Highlights
Research and development expenses for the three months ended
September 30, 2020 were $7.1 million compared to $5.3 million for the same period in 2019.
The increase was primarily due to increased expenses related to
clinical studies, 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
September 30, 2020 were $2.7 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, salaries and benefits and insurance
expenses, partially offset by decreased expenses related to legal
services and travel.
For the three months ended September 30,
2020, Viking reported a net loss of $9.3 million, or $0.13 per share, compared to a net loss of
$5.7 million, or $0.08 per share, in the corresponding period in
2019. The increase in net loss and net loss per share for the
three months ended September 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 third quarter of 2020 as compared to prevailing
interest rates during the third quarter of 2019.
First Nine Months Ended September 30,
2020 and 2019
Research and development expenses for the nine months ended
September 30, 2020 were $22.9 million compared to $17.1 million for the same period in 2019.
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 services provided by
third-party consultants and pre-clinical studies.
General and administrative expenses for the nine months ended
September 30, 2020 were $8.5 million compared to $6.7 million for the same period in 2019.
The increase was primarily due to increased expenses related to
stock-based compensation, salaries and benefits and insurance
expenses, partially offset by decreased expenses related to
services provided by third-party consultants, professional fees and
travel.
For the nine months ended September 30,
2020, Viking reported a net loss of $28.5 million, or $0.39 per share, compared to a net loss of
$18.3 million, or $0.25 per share, in the corresponding period in
2019. The increase in net loss and net loss per share for the
nine months ended September 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 nine months of 2020 as compared to prevailing
interest rates during the first nine months of 2019.
Balance Sheet as of September 30,
2020
At September 30, 2020, Viking held
cash, cash equivalents and short-term investments of $255.3 million compared to $275.6 million as of December 31, 2019.
Conference Call
Management will host a conference call to discuss the company's
third 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
November 4, 2020 by dialing (877)
344-7529 from the U.S. or (412) 317-0088 from outside the U.S. and
entering conference ID #10148182. 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, 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
September
30,
|
|
|
Nine Months
Ended
September
30,
|
|
|
2020
|
|
|
2019
|
|
|
2020
|
|
|
2019
|
Revenues
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
7,116
|
|
|
|
5,279
|
|
|
|
22,882
|
|
|
|
17,108
|
General and
administrative
|
|
|
2,727
|
|
|
|
2,160
|
|
|
|
8,514
|
|
|
|
6,706
|
Total operating
expenses
|
|
|
9,843
|
|
|
|
7,439
|
|
|
|
31,396
|
|
|
|
23,814
|
Loss from
operations
|
|
|
(9,843)
|
|
|
|
(7,439)
|
|
|
|
(31,396)
|
|
|
|
(23,814)
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of
financing costs
|
|
|
(20)
|
|
|
|
(40)
|
|
|
|
(85)
|
|
|
|
(100)
|
Interest income,
net
|
|
|
576
|
|
|
|
1,742
|
|
|
|
2,920
|
|
|
|
5,581
|
Realized gain (loss)
on investments, net
|
|
|
(1)
|
|
|
|
6
|
|
|
|
14
|
|
|
|
4
|
Total other income,
net
|
|
|
555
|
|
|
|
1,708
|
|
|
|
2,849
|
|
|
|
5,485
|
Net loss
|
|
|
(9,288)
|
|
|
|
(5,731)
|
|
|
|
(28,547)
|
|
|
|
(18,329)
|
Other comprehensive
loss, net of tax:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss)
on securities
|
|
|
(379)
|
|
|
|
(82)
|
|
|
|
(58)
|
|
|
|
580
|
Comprehensive
loss
|
|
$
|
(9,667)
|
|
|
$
|
(5,813)
|
|
|
$
|
(28,605)
|
|
|
$
|
(17,749)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
|
$
|
(0.13)
|
|
|
$
|
(0.08)
|
|
|
$
|
(0.39)
|
|
|
$
|
(0.25)
|
Weighted-average
shares used to compute basic and diluted net loss per
share
|
|
|
72,643
|
|
|
|
72,040
|
|
|
|
72,496
|
|
|
|
71,907
|
Viking
Therapeutics, Inc.
|
Balance
Sheets
|
|
(In thousands,
except share and per share amounts)
|
|
|
|
September 30,
2020
|
|
|
December 31,
2019
|
|
|
(Unaudited)
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
3,870
|
|
|
$
|
8,377
|
Short-term investments
– available for sale
|
|
|
251,434
|
|
|
|
267,261
|
Prepaid clinical trial
and preclinical study costs
|
|
|
7,120
|
|
|
|
7,458
|
Prepaid expenses and
other current assets
|
|
|
710
|
|
|
|
405
|
Total current
assets
|
|
|
263,134
|
|
|
|
283,501
|
Right-of-use
assets
|
|
|
392
|
|
|
|
598
|
Deferred public
offering and other financing costs
|
|
|
68
|
|
|
|
128
|
Deposits
|
|
|
29
|
|
|
|
29
|
Total
assets
|
|
$
|
263,623
|
|
|
$
|
284,256
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
2,756
|
|
|
$
|
2,431
|
Other accrued
liabilities
|
|
|
6,636
|
|
|
|
4,044
|
Lease liability,
current
|
|
|
323
|
|
|
|
302
|
Total current
liabilities
|
|
|
9,715
|
|
|
|
6,777
|
Lease liability, net
of current portion
|
|
|
115
|
|
|
|
360
|
Total long-term
liabilities
|
|
|
115
|
|
|
|
360
|
Total
liabilities
|
|
|
9,830
|
|
|
|
7,137
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
Preferred stock,
$0.00001 par value: 10,000,000 shares authorized at September 30,
2020 and December 31, 2019; no shares issued and outstanding at
September 30, 2020 and December 31, 2019
|
|
|
—
|
|
|
|
—
|
Common stock, $0.00001
par value: 300,000,000 shares authorized at September 30, 2020 and
December 31, 2019; 72,921,472 and 72,413,602 shares issued and
outstanding at September 30, 2020 and December 31, 2019,
respectively
|
|
|
1
|
|
|
|
1
|
Additional paid-in
capital
|
|
|
411,082
|
|
|
|
405,803
|
Accumulated
deficit
|
|
|
(157,244)
|
|
|
|
(128,697)
|
Accumulated other
comprehensive income (loss)
|
|
|
(46)
|
|
|
|
12
|
Total stockholders'
equity
|
|
|
253,793
|
|
|
|
277,119
|
Total liabilities and
stockholders' equity
|
|
$
|
263,623
|
|
|
$
|
284,256
|
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SOURCE Viking Therapeutics, Inc.