SAN DIEGO, Feb. 17, 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 fourth quarter and year ended
December 31, 2020, and provided an
update on its clinical pipeline and other corporate
developments.
Highlights from the Quarter and Year Ended December 31, 2020:
"2020 was a strong and productive year for Viking," stated
Brian Lian, Ph.D., chief executive
officer of Viking. "Despite the challenges posed by the
global pandemic, we continued to open clinical sites and proceed
with enrollment in our 52-week Phase 2b VOYAGE trial evaluating VK2809 in patients
with NASH and fibrosis. Importantly, in the face of a
COVID-19 resurgence in recent months, the majority of our U.S.
sites remain open, and we continue to add both U.S. and ex-U.S.
sites. We currently expect to complete enrollment in the
second half of 2021. With respect to our VK0214 program for
X-linked adrenoleukodystrophy, we made excellent progress in 2020
and were pleased to announce last fall the initiation of a
first-in-human study with this important molecule. Pending
successful completion of the Phase 1 single ascending and multiple
ascending dose study, we plan to initiate a
Phase 1b trial in X-ALD patients. On the personnel
side, we recently announced the appointment of Marianne Mancini to the position of COO and Greg
Zante to CFO. Both Marianne and Greg have exhibited strong
leadership in the management of Viking's clinical operations and
financial strategy, respectively, and we are pleased to appoint
them to these roles within the organization."
Pipeline and Corporate Highlights
- Phase 2b VOYAGE study
evaluating VK2809 in biopsy-confirmed non-alcoholic steatohepatitis
(NASH) and fibrosis continues to enroll; new sites opened in the
U.S. and Europe. 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.
During the fourth quarter of 2020, the company continued to enroll
at our U.S. sites, and opened new clinical sites outside the
U.S. The resurgence of the pandemic in recent months
continues to impact enrollment projections. As a result, the
company now expects to complete enrollment of this trial in the
second half of 2021.
- New data from prior VK2809 Phase 2 trial highlighted in EASL
podium presentation. In the third quarter of 2020, new data
from the company's prior 12-week Phase 2 study evaluating VK2809 in
patients with non-alcoholic fatty liver disease and
hypercholesterolemia were highlighted in a podium presentation at
the annual meeting of the International Liver Conference (EASL).
These data demonstrated that patients treated with VK2809 continued
to experience durable, statistically significant reductions in
liver fat content 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 maintained
at 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
demonstrated a response at Week 16.
The presentation also highlighted additional Week 12 results that
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 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.
- Phase 1 SAD/MAD Study of VK0214 Ongoing; Expect to Initiate
Proof-of-Concept Trial in X-ALD Patients in 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 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.
In the third quarter of 2020, the company initiated a Phase 1
first-in-human trial of VK0214. 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
potential clinical development in the setting of X-ALD. The company
expects to complete the SAD/MAD study in the first half of 2021.
Pending evaluation of the results, Viking plans to initiate a Phase
1b proof-of-concept trial in patients
with X-ALD.
- Key appointments to senior management team. Viking
recently announced the appointments of Marianne Mancini as the company's chief
operating officer, and Greg Zante as chief financial officer. Over
the years, Ms. Mancini and Mr. Zante have exhibited strong
leadership in clinical operations and financial strategy,
respectively.
Prior to her appointment as COO, Ms. Mancini served as Viking's
senior vice president of clinical operations. She has more than 30
years of experience in the pharmaceutical and biotech industry, and
has overseen the clinical advancement of the company's VK2809,
VK0214, and VK5211 programs. As COO, Ms. Mancini is responsible for
key clinical and regulatory activities related to our pipeline
programs.
Mr. Zante has nearly 25 years of financial management experience at
public and private companies in the biotechnology and accounting
industries, and most recently served as Viking's senior vice
president of finance. Mr. Zante's contributions to the company's
financial strength and stability have well-positioned Viking to
achieve important clinical milestones with both lead candidates. As
CFO, Greg plays an important role in the management of the
company's financial, business development and investor-relations
activities.
- Balance sheet remains strong with approximately $250 million in cash. Viking completed the
fourth quarter of 2020 with $248.4
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:
10th Annual SVB
Leerink Global Healthcare Conference
Dates: February 24
- 26, 2021
Raymond
James 2021 Institutional Investors
Conference
Dates: March 1 - 3, 2021
H.C. Wainwright Global Life
Sciences Conference
Dates: March
9 – 10, 2021
33rd Annual Roth
Conference
Dates: March 15 –
17, 2021
Oppenheimer's 31st
Annual Healthcare Conference
Dates: March 16 – 17, 2021
20th Annual Needham
Healthcare Conference
Dates: April
12 – 15, 2021
Fourth Quarter and Full-Year 2020 Financial
Highlights
Fourth Quarter Ended December 31,
2020 and 2019
Research and development expenses for the three months ended
December 31, 2020 were $9.0 million compared to $6.5 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
manufacturing for the company's drug candidates and services
provided by third-party consultants.
General and administrative expenses for the three months ended
December 31, 2020 were $2.2 million compared to $2.4 million for the same period in 2019.
The decrease was primarily due to decreased expenses related to
legal and patent services, professional fees and salaries and
benefits, partially offset by increased expenses related to
insurance.
For the three months ended December 31,
2020, Viking reported a net loss of $10.9 million, or $0.15 per share, compared to a net loss of
$7.5 million, or $0.10 per share, in the corresponding period in
2019. The increase in net loss and net loss per share for the
three months ended December 31, 2020
was primarily due to the 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 fourth quarter of 2020 as compared to
prevailing interest rates during the fourth quarter of 2019.
Twelve Months Ended December 31,
2020 and 2019
Research and development expenses for the twelve months ended
December 31, 2020 were $31.9 million compared to $23.6 million for the same period in 2019.
The increase was primarily due to increased expenses related to
clinical studies, salaries and benefits, stock-based
compensation and manufacturing for the company's drug candidates,
partially offset by decreased expenses related to services provided
by third-party consultants, pre-clinical studies and travel.
General and administrative expenses for the twelve months ended
December 31, 2020 were $10.7 million compared to $9.1 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,
partially offset by decreased expenses related to services provided
by third-party consultants, professional fees, legal and patent
expenses, and travel.
For the twelve months ended December 31,
2020, Viking reported a net loss of $39.5 million, or $0.54 per share, compared to a net loss of
$25.8 million, or $0.36 per share, in the corresponding period in
2019. The increase in net loss and net loss per share for the
twelve months ended December 31, 2020
was primarily due to the increases in research and development and
general and administrative expenses noted previously, as well as
decreased interest income primarily due to the decline in interest
rates throughout the twelve months ended December 31, 2020 as compared to prevailing
interest rates during same period in 2019.
Balance Sheet as of December 31,
2020
At December 31, 2020, Viking held
cash, cash equivalents and short-term investments of $248.4 million, compared to $275.6 million as of December 31, 2019.
Conference Call
Management will host a conference call to discuss the company's
fourth quarter and year-end 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 February 24, 2021 by dialing
(877) 344-7529 from the U.S. or (412) 317-0088 from outside the
U.S. and entering conference ID #10150687. 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
December 31,
|
|
|
Year Ended
December 31,
|
|
|
|
2020
|
|
|
2019
|
|
|
2020
|
|
|
2019
|
|
Revenues
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
9,048
|
|
|
|
6,451
|
|
|
|
31,931
|
|
|
|
23,559
|
|
General and
administrative
|
|
|
2,217
|
|
|
|
2,422
|
|
|
|
10,731
|
|
|
|
9,128
|
|
Total operating
expenses
|
|
|
11,265
|
|
|
|
8,873
|
|
|
|
42,662
|
|
|
|
32,687
|
|
Loss from
operations
|
|
|
(11,265)
|
|
|
|
(8,873)
|
|
|
|
(42,662)
|
|
|
|
(32,687)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of
financing costs
|
|
|
(21)
|
|
|
|
(46)
|
|
|
|
(106)
|
|
|
|
(146)
|
|
Interest income,
net
|
|
|
313
|
|
|
|
1,469
|
|
|
|
3,233
|
|
|
|
7,050
|
|
Realized gain on
investments
|
|
|
25
|
|
|
|
—
|
|
|
|
40
|
|
|
|
4
|
|
Total other income,
net
|
|
|
317
|
|
|
|
1,423
|
|
|
|
3,167
|
|
|
|
6,908
|
|
Net loss
|
|
|
(10,948)
|
|
|
|
(7,450)
|
|
|
|
(39,495)
|
|
|
|
(25,779)
|
|
Other comprehensive
loss, net of tax:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss)
on securities
|
|
|
(8)
|
|
|
|
(145)
|
|
|
|
(66)
|
|
|
|
435
|
|
Comprehensive
loss
|
|
$
|
(10,956)
|
|
|
$
|
(7,595)
|
|
|
$
|
(39,561)
|
|
|
$
|
(25,344)
|
|
Basic and diluted net
loss per share
|
|
$
|
(0.15)
|
|
|
$
|
(0.10)
|
|
|
$
|
(0.54)
|
|
|
$
|
(0.36)
|
|
Weighted-average
shares used to compute basic
and diluted net loss
per share
|
|
|
72,896
|
|
|
|
72,115
|
|
|
|
72,597
|
|
|
|
71,959
|
|
Viking
Therapeutics, Inc.
|
Balance
Sheets
|
|
(In thousands,
except share and per share amounts)
|
|
|
|
|
December 31,
2020
|
|
|
December 31,
2019
|
|
|
|
|
(unaudited)
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
29,117
|
|
|
$
|
8,377
|
|
Short-term investments
– available for sale
|
|
|
219,269
|
|
|
|
267,261
|
|
Prepaid clinical trial
and preclinical study costs
|
|
|
7,276
|
|
|
|
7,458
|
|
Prepaid expenses and
other current assets
|
|
|
442
|
|
|
|
405
|
|
Total current
assets
|
|
|
256,104
|
|
|
|
283,501
|
|
Right-of-use
assets
|
|
|
321
|
|
|
|
598
|
|
Deferred public
offering and other financing costs
|
|
|
48
|
|
|
|
128
|
|
Deposits
|
|
|
29
|
|
|
|
29
|
|
Total
assets
|
|
$
|
256,502
|
|
|
$
|
284,256
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
3,988
|
|
|
$
|
2,431
|
|
Other accrued
liabilities
|
|
|
7,811
|
|
|
|
4,044
|
|
Lease liability,
current
|
|
|
330
|
|
|
|
302
|
|
Total current
liabilities
|
|
|
12,129
|
|
|
|
6,777
|
|
Lease liability, net
of current portion
|
|
|
29
|
|
|
|
360
|
|
Total long-term
liabilities
|
|
|
29
|
|
|
|
360
|
|
Total
liabilities
|
|
|
12,158
|
|
|
|
7,137
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
Preferred stock,
$0.00001 par value: 10,000,000 shares authorized at December 31,
2020 and 2019; no shares issued and outstanding at December 31,
2020 and 2019
|
|
|
—
|
|
|
|
—
|
|
Common stock, $0.00001
par value: 300,000,000 shares authorized at December 31, 2020 and
2019; 73,215,940 shares issued and outstanding at December 31, 2020
and 72,413,602 shares issued and outstanding at December 31,
2019
|
|
|
1
|
|
|
|
1
|
|
Additional paid-in
capital
|
|
|
412,589
|
|
|
|
405,803
|
|
Accumulated
deficit
|
|
|
(168,192)
|
|
|
|
(128,697)
|
|
Accumulated other
comprehensive income (loss)
|
|
|
(54)
|
|
|
|
12
|
|
Total stockholders'
equity
|
|
|
244,344
|
|
|
|
277,119
|
|
Total liabilities and
stockholders' equity
|
|
$
|
256,502
|
|
|
$
|
284,256
|
|
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SOURCE Viking Therapeutics, Inc.