SAN DIEGO, Nov. 3, 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 third quarter and nine months ended
September 30, 2021, and provided an
update on its clinical pipeline and other corporate
developments.
Highlights from the Quarter Ended September 30, 2021 and Other Recent
Events:
"The third quarter was a busy and productive time for
Viking as we continued to make progress with our lead clinical
programs targeting NASH and X-ALD, and expanded our pipeline with
an additional program for metabolic disorders," stated Brian Lian, Ph.D., chief executive officer of
Viking. "Enrollment continues in our Phase 2b VOYAGE trial evaluating VK2809, our novel
thyroid hormone beta receptor agonist, in patients with NASH and
fibrosis. During the quarter, we also continued enrollment in our
Phase 1b clinical trial evaluating
VK0214, our second thyroid hormone beta receptor agonist, in
patients with X-ALD. VK0214 has demonstrated a promising
therapeutic profile in preclinical and clinical studies to
date. In addition to our clinical activities, earlier this
week we presented two posters at ObesityWeek®, the
annual meeting of The Obesity Society, highlighting promising
initial data from a series of novel, internally developed dual
agonists of the GLP-1 and GIP receptors. These compounds
produced significant improvements in metabolic profile in an in
vivo model of NASH and obesity, and we expect to begin clinical
development with this program in the coming months. Finally,
supporting our development activities is a strong balance sheet
that has positioned the company well to advance our clinical
programs into late-stage development."
Pipeline and Corporate Highlights
- Phase 2b VOYAGE study
evaluating VK2809 for the treatment of NASH ongoing.
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. The compound has
demonstrated promising therapeutic potential in a range of lipid
disorders, including non-alcoholic steatohepatitis (NASH). A
prior 12-week Phase 2a study evaluating VK2809 in patients with
non-alcoholic fatty-liver disease and hypercholesterolemia,
successfully achieved both its primary and secondary endpoints,
with treated patients demonstrating highly statistically
significant reductions in liver fat content as well as improvements
in LDL-cholesterol (LDL-C). Patients receiving VK2809 in this
study also demonstrated significant reductions in other plasma
lipids, such as triglycerides, apolipoprotein b, and lipoprotein
(a). These data suggest important cardiometabolic benefits
for patients, a distinction that may represent an advantage
compared with mechanisms that have been associated with elevations
in lipids known to increase cardiovascular risk. No serious
adverse events were reported in this trial among patients receiving
VK2809 or placebo. Findings from follow-up evaluations of the
Phase 2a data, most recently in an oral presentation during the
2020 EASL conference, where the compound's durability and breadth
of activity across various NASH risk factors were highlighted,
continue to strengthen the promising therapeutic profile of
VK2809.
VK2809 is currently being evaluated in a Phase 2b trial in patients with NASH. This trial,
called VOYAGE, 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. The study is targeting enrollment of 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 third quarter, screening and enrollment continued at
both U.S. and ex-U.S. study sites, and the company expects to
report the initial data from this trial in 2022.
- Phase 1b proof-of-concept
trial evaluating VK0214 in X-ALD patients underway.
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 are currently no pharmacologic treatment options.
Earlier this year, the company completed the first clinical study
of VK0214; a randomized, double-blind, placebo-controlled, single
ascending dose and 14-day multiple ascending dose Phase 1 study
evaluating the safety, tolerability, and pharmacokinetics of VK0214
in healthy volunteers. This study successfully achieved its
primary objective, with VK0214 shown to be safe and well-tolerated
at all doses evaluated.
Subjects receiving VK0214 in the 14-day multiple ascending dose
study experienced reductions in LDL-C, triglycerides, and other
plasma lipids, many of which reached statistical
significance. No serious adverse events were reported in the
Phase 1 study, and no treatment- or dose-related trends were
observed for gastrointestinal side effects, vital signs, or
cardiovascular measures. Treatment with VK0214 demonstrated
dose-dependent exposures, no evidence of accumulation, and a
half-life consistent with anticipated once-daily oral dosing.
In June 2021, the company initiated a
four-week Phase 1b study of VK0214.
This trial is a randomized, double-blind,
placebo-controlled, multi-center study in adult male patients with
the adrenomyeloneuropathy (AMN) form of X-ALD. AMN is the
most common form of X-ALD, affecting approximately 50% of those
with the disease. The study is initially targeting enrollment
across three cohorts: placebo, VK0214 dosed at 20 mg daily, and
VK0214 dosed at 40 mg daily. Pending a blinded review of
preliminary safety, tolerability, and pharmacokinetic data,
additional dosing cohorts may be pursued.
The primary objectives of the study are to evaluate the safety and
tolerability of VK0214 administered once-daily over a 28-day dosing
period, and to assess the efficacy of VK0214 at lowering plasma
levels of very long chain fatty acids (VLCFAs) in patients with
AMN. Secondary objectives include an evaluation of the
pharmacokinetics of VK0214 in this population. The company
currently expects top-line results from this study to be available
in 2022.
- Data from new program focused on dual incretin receptor
agonists presented at
ObesityWeek® 2021. The company
recently announced results from preclinical studies of a
wholly-owned, internally developed series of dual-acting agonists
of the glucagon-like peptide-1, or GLP-1, and the glucose-dependent
insulinotropic polypeptide, or GIP, receptors. These
compounds may provide therapeutic benefit in a range of metabolic
disorders, such as NASH, obesity, and type 2 diabetes.
Initial data from this program were presented this week in two
posters at ObesityWeek 2021, the annual meeting of The Obesity
Society.
Highlights from the posters include:
-
- Treatment with Viking dual agonists for 21 days resulted in
mean reductions in body weight of up to 27% relative to vehicle
(p<0.0001), compared with a mean reduction of 18% among
semaglutide-treated animals (p<0.0001 vs. semaglutide)
- Treatment with Viking dual agonists resulted in mean reductions
in blood glucose of up to 23% relative to vehicle (p<0.0001),
compared with a mean reduction of 7% among semaglutide-treated
animals (p<0.0001 vs. semaglutide)
- In the same study, treatment with Viking dual agonists resulted
in mean reductions in plasma insulin of up to 57% relative to
vehicle (p<0.0001), compared with a mean reduction of 35% among
semaglutide-treated animals (p = non-significant vs.
semaglutide)
- In a separate 14-day study, treatment with Viking dual agonists
resulted in mean reductions in body weight of up to 28% vs. vehicle
(p<0.0001) and plasma glucose of up to 26% vs. vehicle
(p<0.0001) that were comparable to mean reductions observed
among tirzepatide-treated animals of 29% and 25%, respectively, vs.
vehicle
- Treatment with Viking dual agonists resulted in mean reductions
in plasma triglycerides of up to 37% relative to vehicle (p=0.004)
compared with a 29% mean reduction among tirzepatide-treated
animals (p = non-significant vs. tirzepatide)
- Treatment with Viking dual agonists resulted in mean reductions
in liver triglycerides of up to 49% relative to vehicle (p=0.01),
compared with a 19% mean reduction among tirzepatide-treated
animals (p<0.05 vs. tirzepatide)
Based on the results from these
and other preclinical studies, the company plans to initiate
clinical development of a lead candidate from this program in the
coming months.
- Strong balance sheet continues to support advancement of
clinical programs into late stage development. Viking ended the
third quarter of 2021 with approximately $216 million in cash, cash equivalents and
short-term investments.
- Upcoming investor events. Viking management will
participate virtually in the following upcoming investor
events:
Stifel 2021 Virtual Healthcare
Conference
Dates: November 15 - 17, 2021
H.C. Wainwright BioConnect 2022
Conference
Dates: January 10 -13, 2022
BIO One-on-One Partnering at
JPM
Dates: January 10 - 14, 2022
Third Quarter and Nine Month Financial Highlights
Third Quarter Ended September 30,
2021 and 2020
Research and development expenses for the three months ended
September 30, 2021 were $10.8 million compared to $7.1 million for the same period in 2020. The
increase was primarily due to increased expenses related to
manufacturing for the company's drug candidates, clinical and
pre-clinical studies and services provided by third-party
consultants, partially offset by decreased expenses related to
salaries and benefits and stock-based compensation.
General and administrative expenses for the three months ended
September 30, 2021 were $2.6 million compared to $2.7 million for the same period in 2020. The
decrease was primarily due to decreased expenses related to
salaries and benefits, partially offset by increased expenses
related to stock-based compensation, insurance and legal
services.
For the three months ended September 30,
2021, Viking reported a net loss of $13.2 million, or $0.17 per share, compared to a net loss of
$9.3 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 September 30, 2021 was
primarily due to the increase in research and development expenses,
partially offset by the decrease in general and administrative
expenses, noted previously, as well as decreased interest income
primarily due to the decline in interest rates available throughout
the third quarter of 2021 as compared to prevailing interest rates
during the same period in 2020.
Nine Months Ended September 30,
2021 and 2020
Research and development expenses for the nine months ended
September 30, 2021 were $35.1 million compared to $22.9 million for the same period in 2020. The
increase was primarily due to increased expenses related to
clinical and pre-clinical studies, manufacturing for the company's
drug candidates, services provided by third-party consultants and
stock-based compensation, partially offset by decreased expenses
related to salaries and benefits.
General and administrative expenses for the nine months ended
September 30, 2021 were $8.0 million compared to $8.5 million for the same period in 2020. The
decrease was primarily due to decreased expenses related to
salaries and benefits, stock-based compensation and legal services,
partially offset by increased expenses related to insurance,
professional fees and services provided by third-party
consultants.
For the nine months ended September 30,
2021, Viking reported a net loss of $42.6 million, or $0.55 per share, compared to a net loss of
$28.5 million, or $0.39 per share, in the corresponding period in
2020. The increase in net loss and net loss per share for the nine
months ended September 30, 2021 was
primarily due to the increase in research and development expenses,
partially offset by the decrease in general and administrative
expenses, noted previously, as well as decreased interest income
primarily due to the decline in interest rates available throughout
the nine months ended September 30,
2021 as compared to prevailing interest rates during same
period in 2020.
Balance Sheet as of September 30,
2021
At September 30, 2021, Viking held
cash, cash equivalents and short-term investments of $216.1 million, compared to $248.4 million as of December 31, 2020.
Conference Call
Management will host a conference call to discuss the company's
third 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 November 10, 2021 by dialing (877) 344-7529 from
the U.S. or (412) 317-0088 from outside the U.S. and entering
conference ID #10160763. 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
2a 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's second clinical candidate is 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 1b clinical
trial in patients with the adrenomyeloneuropathy (AMN) form of
X-ALD. 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. The company is also developing
a wholly-owned series of novel dual agonists of the GLP-1 and GIP
receptors, for the potential treatment of metabolic disorders.
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, as well as
the company's goals and plans regarding its preclinical programs,
including those targeting dual incretin receptor agonists, and
their 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
VK0214, VK5211, VK2809, and the company's dual-incretin receptor
agonists; 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
September
30,
|
|
|
Nine Months
Ended
September
30,
|
|
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
|
Revenues
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
10,795
|
|
|
|
7,116
|
|
|
|
35,134
|
|
|
|
22,882
|
|
General and
administrative
|
|
|
2,608
|
|
|
|
2,727
|
|
|
|
8,038
|
|
|
|
8,514
|
|
Total operating
expenses
|
|
|
13,403
|
|
|
|
9,843
|
|
|
|
43,172
|
|
|
|
31,396
|
|
Loss from
operations
|
|
|
(13,403)
|
|
|
|
(9,843)
|
|
|
|
(43,172)
|
|
|
|
(31,396)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of
financing costs
|
|
|
35
|
|
|
|
(20)
|
|
|
|
(6)
|
|
|
|
(85)
|
|
Interest income,
net
|
|
|
125
|
|
|
|
576
|
|
|
|
544
|
|
|
|
2,920
|
|
Realized gain on
investments, net
|
|
|
—
|
|
|
|
(1)
|
|
|
|
—
|
|
|
|
14
|
|
Total other income,
net
|
|
|
160
|
|
|
|
555
|
|
|
|
538
|
|
|
|
2,849
|
|
Net loss
|
|
|
(13,243)
|
|
|
|
(9,288)
|
|
|
|
(42,634)
|
|
|
|
(28,547)
|
|
Other comprehensive
loss, net of tax:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss)
on securities
|
|
|
19
|
|
|
|
(379)
|
|
|
|
(116)
|
|
|
|
(58)
|
|
Comprehensive
loss
|
|
$
|
(13,224)
|
|
|
$
|
(9,667)
|
|
|
$
|
(42,750)
|
|
|
$
|
(28,605)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
|
$
|
(0.17)
|
|
|
$
|
(0.13)
|
|
|
$
|
(0.55)
|
|
|
$
|
(0.39)
|
|
Weighted-average
shares used to compute basic and diluted net loss per
share
|
|
|
78,009
|
|
|
|
72,643
|
|
|
|
76,908
|
|
|
|
72,496
|
|
Viking
Therapeutics, Inc.
Balance
Sheets
(In thousands,
except share and per share amounts)
|
|
|
|
September 30,
2021
|
|
|
December 31,
2020
|
|
|
|
(Unaudited)
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
11,264
|
|
|
$
|
29,117
|
|
Short-term investments
– available for sale
|
|
|
204,871
|
|
|
|
219,269
|
|
Prepaid clinical trial
and preclinical study costs
|
|
|
7,235
|
|
|
|
7,276
|
|
Prepaid expenses and
other current assets
|
|
|
915
|
|
|
|
442
|
|
Total current
assets
|
|
|
224,285
|
|
|
|
256,104
|
|
Right-of-use
assets
|
|
|
101
|
|
|
|
321
|
|
Deferred financing
costs
|
|
|
88
|
|
|
|
48
|
|
Deposits
|
|
|
—
|
|
|
|
29
|
|
Total
assets
|
|
$
|
224,474
|
|
|
$
|
256,502
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
2,852
|
|
|
$
|
3,988
|
|
Other accrued
liabilities
|
|
|
8,386
|
|
|
|
7,811
|
|
Lease liability,
current
|
|
|
115
|
|
|
|
330
|
|
Total current
liabilities
|
|
|
11,353
|
|
|
|
12,129
|
|
Lease liability, net
of current portion
|
|
|
—
|
|
|
|
29
|
|
Total long-term
liabilities
|
|
|
—
|
|
|
|
29
|
|
Total
liabilities
|
|
|
11,353
|
|
|
|
12,158
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
Preferred stock,
$0.00001 par value: 10,000,000 shares authorized at September 30,
2021 and December 31, 2020; no shares issued and outstanding at
September 30, 2021 and December 31, 2020
|
|
|
—
|
|
|
|
—
|
|
Common stock, $0.00001
par value: 300,000,000 shares authorized at September 30, 2021 and
December 31, 2020; 78,234,889 and 73,215,940 shares issued and
outstanding at September 30, 2021 and December 31, 2020,
respectively
|
|
|
1
|
|
|
|
1
|
|
Additional paid-in
capital
|
|
|
424,116
|
|
|
|
412,589
|
|
Accumulated
deficit
|
|
|
(210,826)
|
|
|
|
(168,192)
|
|
Accumulated other
comprehensive loss
|
|
|
(170)
|
|
|
|
(54)
|
|
Total stockholders'
equity
|
|
|
213,121
|
|
|
|
244,344
|
|
Total liabilities and
stockholders' equity
|
|
$
|
224,474
|
|
|
$
|
256,502
|
|
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SOURCE Viking Therapeutics, Inc.