SAN DIEGO, July 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 second quarter and six months ended
June 30, 2021, and provided an update
on its clinical pipeline and other corporate developments.
Highlights from the Quarter Ended June
30, 2021:
"During the second quarter of 2021, we continued to make good
progress with our lead program VK2809 for the treatment of NASH and
fibrosis. Concurrently, we successfully completed the first
clinical study of our VK0214 program, and initiated a Phase
1b study with VK0214 in patients with
the adrenomyeloneuropathy form of X-ALD," stated Brian Lian, Ph.D., chief executive officer of
Viking. "Screening and enrollment continue at a steady pace
in our 52-week Phase 2b VOYAGE study
of VK2809 in patients with biopsy-confirmed NASH. Based on
data to-date, we believe VK2809 will be a best-in-class therapeutic
and are optimistic about its potential in the setting of
NASH. With respect to our VK0214 program, last month we
reported the results of our first-in-human Phase 1 study of VK0214
in healthy volunteers. The study achieved its primary and
secondary objectives, demonstrating encouraging safety and
tolerability, along with significant reductions in key lipids.
Based on these results, we initiated a Phase 1b clinical trial in patients with
adrenomyeloneuropathy and are excited to move this program
forward. We expect to report data from both the VOYAGE trial
and the Phase 1b study of VK0214 in
2022. Finally, we continue to carefully manage our cash and
maintain a strong balance sheet to support our ongoing trials as
well as potential future clinical studies."
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. The compound has demonstrated promising therapeutic
potential in a range of lipid disorders, including non-alcoholic
steatohepatitis (NASH). The company's 12-week Phase 2a study
in patients with non-alcoholic fatty liver disease and
hypercholesterolemia successfully achieved its primary and
secondary endpoints. Top-line results showed that
VK2809-treated patients had 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%. VK2809 also
demonstrated an encouraging safety and tolerability profile.
Follow-on data from this study demonstrated VK2809's efficacy was
maintained four weeks after the last study dose. Importantly,
reductions in other lipids such as low-density lipoprotein
cholesterol (LDL-C), apolipoprotein B (ApoB), and lipoprotein(a)
[Lp(a)] produced by VK2809 suggest important cardiometabolic
benefits for patients, a distinction that may represent an
advantage compared with other mechanisms in development for
NASH that have been associated with elevations in lipids known to
increase cardiovascular risk.
VK2809 is currently being evaluated in the company's Phase
2b VOYAGE trial. 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 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 second quarter, screening and enrollment continued at
both U.S. and ex-U.S. study sites. The company expects to
report the initial data from this study in 2022.
- Phase 1 study evaluating VK0214 achieves primary and
secondary objectives; Phase 1b
proof-of-concept trial 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 is currently no pharmacologic treatment option.
In September 2020, the company
initiated a Phase 1 first-in-human study of VK0214. This
trial was a randomized, double-blind, placebo-controlled, single
ascending and multiple ascending dose study in healthy
volunteers. The primary objective of the study was to
evaluate the safety and tolerability of VK0214 administered orally
for up to 14 days. The secondary objective was to evaluate
the pharmacokinetics of VK0214 following single and multiple oral
doses. The first portion of the study evaluated single doses
of VK0214; in the second portion of the study subjects received
VK0214 once daily for 14 days. Subsequent cohorts in both
parts of the study received successively higher VK0214 doses.
In June, the company announced that the study had successfully
achieved its primary objective, showing VK0214 to be safe and
well-tolerated at all doses evaluated, and no serious adverse
events were reported. Further, results demonstrated dose-dependent
exposures, no evidence of accumulation following multiple doses,
and a half-life consistent with anticipated once-daily dosing
regimens.
A secondary objective of the study was to evaluate laboratory
assessments, including a lipid panel to determine potential
pharmacodynamic effects following exposure to VK0214. The
results showed that subjects who received VK0214 experienced
reductions in LDL-C, triglycerides, and ApoB following 14 days of
treatment at all VK0214 doses. Many of the observed lipid
reductions achieved statistical significance, though the study was
not powered to demonstrate statistical significance on laboratory
assessments.
Given the safety, tolerability and lipid-reducing activity observed
in healthy volunteers, the company recently initiated a Phase
1b clinical trial in patients with
X-ALD. The Phase 1b trial is a multi-center,
randomized, double-blind, placebo-controlled 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. Clinical manifestations
include progressive leg weakness, incontinence, and sexual
dysfunction. The study is initially targeting enrollment
across three cohorts: placebo, VK0214 20 mg daily, and VK0214 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 and pharmacodynamics of VK0214 following 28 days
of dosing in this population. The company expects top-line
results from this study to be available in 2022.
- Strong balance sheet provides runway to complete multiple
key clinical milestones. Viking ended the second quarter
of 2021 with $228.3 million in cash, cash equivalents and
short-term investments.
- Upcoming investor events. Viking management will
participate virtually in the following upcoming investor
events:
BTIG Virtual Biotechnology
Conference
Dates: August 9 - 10, 2021
Citi's 16th Annual
Biopharma Virtual Conference
Dates: September 8 - 10,
2021
H.C. Wainwright 23rd
Annual Global Investment Conference
Dates: September
13 - 15, 2021
Oppenheimer Fall Healthcare
Life Sciences & MedTech Summit
Dates: September 20
- 23, 2021
Cantor Fitzgerald Virtual
Global Healthcare Conference
Dates: September 27 – 29
Second Quarter and Six Month Financial
Highlights
Second Quarter Ended June 30,
2021 and 2020
Research and development expenses for the three
months ended June 30, 2021 were
$12.8 million compared to
$7.8 million for the same period in
2020. The increase was primarily due to increased expenses
related to clinical and preclinical studies, partially offset by
decreased expenses related to manufacturing for the company's drug
candidates, salaries and benefits and stock-based compensation.
General and administrative expenses for the three months ended
June 30, 2021 were $2.7 million compared to $2.8 million for the same period in 2020.
The decrease was primarily due to decreased expenses related to
salaries and benefits and stock-based compensation, partially
offset by increased expenses related to third-party consultants,
professional fees and insurance.
For the three months ended June 30,
2021, Viking reported a net loss of $15.4 million, or $0.20 per share, compared to a net loss of
$9.6 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 June 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 second quarter of 2021 as compared to prevailing interest rates
during the second quarter of 2020.
Six Months Ended June 30, 2021
and 2020
Research and development expenses for the six months ended
June 30, 2021 were $24.3 million compared to $15.8 million for the same period in 2020.
The increase was primarily due to increased expenses related to
clinical and preclinical studies, manufacturing for the company's
drug candidates and stock-based compensation, partially offset by
decreased expenses related to services provided by third-party
consultants.
General and administrative expenses for the six months ended
June 30, 2021 were $5.4 million compared to $5.8 million for the same period in 2020.
The decrease was primarily due to decreased expenses related to
stock-based compensation, salaries and benefits, legal and travel,
partially offset by increased expenses related to professional
fees, insurance and services provided by third-party
consultants.
For the six months ended June 30,
2021, Viking reported a net loss of $29.4 million, or $0.38 per share, compared to a net loss of
$19.3 million, or $0.27 per share, in the corresponding period in
2020. The increase in net loss and net loss per share for the
six months ended June 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 throughout the six
months ended June 30, 2021 as
compared to prevailing interest rates during same period in
2020.
Balance Sheet as of June 30,
2021
At June 30, 2021, Viking held
cash, cash equivalents and short-term investments of $228.3 million, compared to $248.4 million as of December 31, 2020.
Conference Call
Management will host a conference call to discuss the company's
second 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
August 4, 2021 by dialing (877)
344-7529 from the U.S. or (412) 317-0088 from outside the U.S. and
entering conference ID #10157666. 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 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 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.
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
June
30,
|
|
|
Six Months
Ended
June
30,
|
|
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
|
Revenues
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
12,804
|
|
|
|
7,780
|
|
|
|
24,340
|
|
|
|
15,766
|
|
General and
administrative
|
|
|
2,737
|
|
|
|
2,826
|
|
|
|
5,430
|
|
|
|
5,787
|
|
Total operating
expenses
|
|
|
15,541
|
|
|
|
10,606
|
|
|
|
29,770
|
|
|
|
21,553
|
|
Loss from
operations
|
|
|
(15,541)
|
|
|
|
(10,606)
|
|
|
|
(29,770)
|
|
|
|
(21,553)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of
financing costs
|
|
|
(21)
|
|
|
|
(20)
|
|
|
|
(41)
|
|
|
|
(65)
|
|
Interest income,
net
|
|
|
181
|
|
|
|
1,040
|
|
|
|
420
|
|
|
|
2,344
|
|
Realized gain on
investments, net
|
|
|
—
|
|
|
|
14
|
|
|
|
—
|
|
|
|
15
|
|
Total other income,
net
|
|
|
160
|
|
|
|
1,034
|
|
|
|
379
|
|
|
|
2,294
|
|
Net loss
|
|
|
(15,381)
|
|
|
|
(9,572)
|
|
|
|
(29,391)
|
|
|
|
(19,259)
|
|
Other comprehensive
loss, net of tax:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss)
on securities
|
|
|
(85)
|
|
|
|
1,145
|
|
|
|
(135)
|
|
|
|
321
|
|
Comprehensive
loss
|
|
$
|
(15,466)
|
|
|
$
|
(8,427)
|
|
|
$
|
(29,526)
|
|
|
$
|
(18,938)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
|
$
|
(0.20)
|
|
|
$
|
(0.13)
|
|
|
$
|
(0.38)
|
|
|
$
|
(0.27)
|
|
Weighted-average
shares used to compute basic and diluted net loss per
share
|
|
|
77,897
|
|
|
|
72,487
|
|
|
|
76,348
|
|
|
|
72,422
|
|
Viking
Therapeutics, Inc.
Balance
Sheets
(In thousands,
except share and per share amounts)
|
|
|
|
June 30,
2021
|
|
|
December 31,
2020
|
|
|
|
(Unaudited)
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
8,829
|
|
|
$
|
29,117
|
|
Short-term investments
– available for sale
|
|
|
219,429
|
|
|
|
219,269
|
|
Prepaid clinical trial
and preclinical study costs
|
|
|
8,254
|
|
|
|
7,276
|
|
Prepaid expenses and
other current assets
|
|
|
1,150
|
|
|
|
442
|
|
Total current
assets
|
|
|
237,662
|
|
|
|
256,104
|
|
Right-of-use
assets
|
|
|
176
|
|
|
|
321
|
|
Deferred financing
costs
|
|
|
7
|
|
|
|
48
|
|
Deposits
|
|
|
—
|
|
|
|
29
|
|
Total
assets
|
|
$
|
237,845
|
|
|
$
|
256,502
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
4,210
|
|
|
$
|
3,988
|
|
Other accrued
liabilities
|
|
|
8,463
|
|
|
|
7,811
|
|
Lease liability,
current
|
|
|
198
|
|
|
|
330
|
|
Total current
liabilities
|
|
|
12,871
|
|
|
|
12,129
|
|
Lease liability, net
of current portion
|
|
|
—
|
|
|
|
29
|
|
Total long-term
liabilities
|
|
|
—
|
|
|
|
29
|
|
Total
liabilities
|
|
|
12,871
|
|
|
|
12,158
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
Preferred stock,
$0.00001 par value: 10,000,000 shares authorized at June 30, 2021
and December 31, 2020; no shares issued and outstanding at June 30,
2021 and December 31, 2020
|
|
|
—
|
|
|
|
—
|
|
Common stock, $0.00001
par value: 300,000,000 shares authorized at June 30, 2021 and
December 31, 2020; 78,189,814 and 73,215,940 shares issued and
outstanding at June 30, 2021 and December 31, 2020,
respectively
|
|
|
1
|
|
|
|
1
|
|
Additional paid-in
capital
|
|
|
422,745
|
|
|
|
412,589
|
|
Accumulated
deficit
|
|
|
(197,583)
|
|
|
|
(168,192)
|
|
Accumulated other
comprehensive loss
|
|
|
(189)
|
|
|
|
(54)
|
|
Total stockholders'
equity
|
|
|
224,974
|
|
|
|
244,344
|
|
Total liabilities and
stockholders' equity
|
|
$
|
237,845
|
|
|
$
|
256,502
|
|
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SOURCE Viking Therapeutics, Inc.