Conference call scheduled for 4:30 p.m. ET today
- Phase 2 VENTURE Trial of GLP-1/GIP Agonist VK2735 in Obesity
Fully Enrolled; Results Expected 1H24
- Phase 2b VOYAGE Study
Evaluating VK2809 for the Treatment of NASH and Fibrosis Ongoing;
Histology Results Expected 1H24
- Phase 1 Trial of Oral VK2735 Continues to Enroll; Results
Expected 1Q24
- Strong Quarter-End Cash Position of $376M
SAN
DIEGO, Oct. 25, 2023 /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, 2023, and provided an
update on its clinical pipeline and other corporate
developments.
Highlights from the Quarter Ended September 30, 2023, and Other Recent
Events:
"The third quarter of 2023 has been an exciting period for
Viking," stated Brian Lian, Ph.D.,
chief executive officer of Viking. "We filed an IND for a Phase 2
trial for our newest program, VK2735, for obesity, and subsequently
initiated the Phase 2 VENTURE study to assess the efficacy of this
compound over a 13-week treatment period. As we recently
announced, the high level of interest in this trial allowed us to
enroll the study more rapidly than anticipated, and to exceed our
original enrollment target. We also continued enrollment in a
Phase 1 study evaluating an oral formulation of VK2735 to determine
its preliminary safety, tolerability, and pharmacokinetic and
pharmacodynamic profile. We expect to report data from both
of these studies in the first half of 2024. We also continued
to advance our best-in-class thyroid hormone receptor beta agonist,
VK2809, for NASH and fibrosis, and remain on track to report the
histology results from the 52-week VOYAGE study in the first half
of next year. As we advance our pipeline, we remain
disciplined with our finances and maintain a strong balance sheet
of approximately $376 million. We
expect this to provide operating runway through value-creating
milestones for each of our programs."
Pipeline and Recent Corporate Highlights
- Initiated Phase 2 VENTURE Trial Evaluating Dual
GLP-1/GIP Agonist VK2735 in Patients with Obesity; Results Expected
1H24. VK2735 is a
wholly owned dual agonist of the glucagon like peptide-1, or GLP-1
receptor, and the glucose dependent insulinotropic polypeptide, or
GIP receptor, for the potential treatment of various metabolic
disorders such as obesity, non-alcoholic steatohepatitis (NASH),
and certain rare disorders.
During the first quarter of 2023, the company
announced positive results from a Phase 1 single ascending dose
(SAD) and multiple ascending dose (MAD) clinical trial of VK2735,
which demonstrated that treatment with VK2735 was safe and
well-tolerated following weekly dosing for 28 days in healthy obese
volunteers. In the SAD portion of the Phase 1 study, VK2735
demonstrated promising safety and tolerability, as well as a
predictable pharmacokinetic profile. Following single
subcutaneous doses, VK2735 demonstrated a half-life of
approximately 170 to 250 hours and excellent therapeutic
exposures.
In the 28-day MAD portion of the study, VK2735
demonstrated encouraging safety and tolerability, and positive
signs of clinical activity. All cohorts receiving VK2735
experienced reductions in mean body weight from baseline, ranging
up to 7.8%. Cohorts receiving VK2735 also demonstrated
reductions in mean body weight relative to placebo, ranging up to
6.0%. Statistically significant differences compared to
placebo were maintained or improved at the Day 43 follow-up time
point, 21 days after the last dose of VK2735 was
administered.
VK2735 also demonstrated
encouraging safety and tolerability following repeated
dosing. The majority of observed adverse events (98%) were
reported as mild or moderate, and the majority of gastrointestinal
(GI)-related adverse events (99%) were also reported as mild or
moderate.
These results were featured earlier this month
in an oral presentation at ObesityWeek®, the annual
meeting of the Obesity Society. The presentation highlighted the
previously reported safety, tolerability, and weight loss findings,
as well as new data demonstrating VK2735's impact on liver fat and
plasma lipids. Notably, after four weekly doses of VK2735,
subjects in the Phase 1 trial reported liver fat reductions of up
to 47% from baseline (placebo-adjusted, p<0.01). Among subjects
with non-alcoholic fatty liver disease (NAFLD), placebo-adjusted
reductions in liver fat reached approximately 59% (p<0.01).
Though the sample size was limited, these results may
indicate VK2735's potential benefit in patients with various forms
of fatty liver disease.
The ObesityWeek presentation also highlighted
VK2735's effects on plasma lipids. Despite normal baseline
plasma lipid levels among these healthy volunteers, treatment with
VK2735 produced encouraging reductions from baseline in total
cholesterol (up to 21%), low-density lipoprotein cholesterol
(LDL-C; up to 23%), and apolipoprotein B [Apo(B); up to 21%].
During the third quarter, Viking initiated the
Phase 2 VENTURE trial, evaluating VK2735 in patients with
obesity. The VENTURE trial is a randomized, double-blind,
placebo-controlled multicenter study that is evaluating the safety,
tolerability, pharmacokinetics, and weight loss efficacy of VK2735,
administered subcutaneously, once weekly for 13 weeks. The
trial was designed to enroll approximately 125 adults who are obese
(BMI ≥30 kg/m2), or adults who are overweight (BMI ≥27
kg/m2) with at least one weight-related comorbid
condition. Due to heightened clinician and patient interest,
the trial's enrollment target was increased to 176 patients from
the original target of 125 patients. The primary endpoint of
the study will assess the percent change in body weight from
baseline to Week 13 among patients treated with VK2735 as compared
with placebo, with secondary and exploratory endpoints evaluating a
range of additional safety and efficacy measures. The
VENTURE trial will evaluate weekly VK2735 doses of up to 15 mg,
compared to the 10 mg top dose evaluated in the prior Phase 1 MAD
study.
The company recently announced completion of
enrollment in VENTURE and expects to report the results from this
study in 1H24.
- Phase 1 Trial Evaluating Novel Oral Formulation of VK2735
Continues to Enroll; Data Expected in 1Q24. Concurrent
with the announcement of results from the Phase 1 trial of the
subcutaneous injectable formulation of VK2735, Viking initiated a
Phase 1 clinical study to evaluate a novel oral formulation of
VK2735. The company believes the potential to provide both
subcutaneous and oral dosage forms may represent an important
option for patients, and may significantly expand the market
opportunity for VK2735.
The Phase 1 study, which is an extension of the
SAD/MAD Phase 1 trial described above, is a randomized,
double-blind, placebo-controlled trial in healthy adults with a
minimum BMI of 30 kg/m2. The primary objective of
the study is to evaluate the safety and tolerability of VK2735
administered as an oral tablet once daily for 28 days. The
secondary objective is to evaluate the pharmacokinetics of orally
administered VK2735 in healthy subjects. Exploratory
pharmacodynamic measures include assessments of changes in body
weight and other metrics.
The company expects to report the initial
data from the oral formulation Phase 1 study in 1Q24.
- Phase 2b VOYAGE Study
Evaluating VK2809 for the Treatment of NASH and Fibrosis Ongoing;
Histology Results Expected 1H24. VK2809 is an orally available,
small molecule agonist of the thyroid hormone receptor that is
selective for liver tissue as well as the beta isoform of the
receptor. During the second quarter, the company announced positive
top-line results from the Phase 2b
VOYAGE study evaluating VK2809 in patients with
biopsy-confirmed NASH and fibrosis. The study achieved its
primary endpoint, with patients receiving VK2809 experiencing
statistically significant reductions in liver fat content from
baseline to Week 12 as compared with placebo. The median relative
change from baseline in liver fat as assessed by magnetic resonance
imaging, proton density fat fraction (MRI-PDFF) ranged from 38% to
55% for patients receiving VK2809. Importantly, up to 85% of
patients receiving VK2809 experienced at least a 30% relative
reduction in liver fat content (p<0.0001), a level of reduction
that is associated with greater likelihood of histologic
improvement in NASH. Additionally, VK2809-treated patients
demonstrated statistically significant reductions in low-density
lipoprotein cholesterol (LDL-C), triglycerides, and atherogenic
lipoproteins, all of which have been correlated with cardiovascular
risk. These findings support prior data demonstrating that VK2809
may offer a cardio-protective benefit through its robust reduction
in plasma lipids.
The VOYAGE data also confirmed previously
reported results demonstrating VK2809's encouraging safety and
tolerability profile. After 12 weeks, 94% of treatment
related adverse events among patients receiving VK2809 were
reported as mild or moderate. As in prior studies, VK2809
demonstrated excellent GI tolerability, with rates of nausea,
diarrhea, stool frequency, and vomiting similar among
VK2809-treated patients compared to placebo.
The company expects to report data from the
secondary and exploratory objectives of the study, including the
evaluation of histologic changes assessed by hepatic biopsy after
52 weeks of treatment, in the first half of 2024.
- VOYAGE Primary Endpoint Results Selected for Late Breaking
Presentation at The Liver Meeting, 2023. The results for the
primary endpoint of the VOYAGE Phase 2b study have been selected for poster
presentation at the upcoming meeting of the American Association
for the Study of Liver Diseases (AASLD). Abstract 48541, titled
"The Novel Thyroid Hormone Receptor Beta Agonist VK2809
Significantly Reduces Liver Fat in Patients with NASH and Fibrosis,
Results from the Primary Endpoint of the Ongoing Phase 2b VOYAGE Study," will be presented at the Late
Breaking Poster Session, scheduled for Monday, November 13 at 1:00 pm ET.
- Phase 1b Study of VK0214 in
X-ALD Continues to Enroll. 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 neurogenerative disease for which there are currently no
pharmacologic treatment options.
Results from a prior Phase 1 study of VK0214 in
healthy volunteers successfully achieved its primary and secondary
endpoints demonstrating dose-dependent exposures, no evidence of
accumulation, and a half-life consistent with once-daily dosing.
VK0214 demonstrated encouraging safety and tolerability in this
study, with no serious adverse events observed and no differences
reported for GI side effects such as nausea or diarrhea among
subjects treated with VK0214 compared with placebo.
Following completion of the Phase 1 study, the
company initiated a Phase 1b study of
VK0214 in patients with the adrenomyeloneuropathy, or AMN, form of
X-ALD, which is the most common form of the disorder. The Phase
1b trial is a randomized,
double-blind, placebo-controlled multi-center study in adult male
patients with AMN. The primary objectives of the study are to
evaluate the safety and tolerability of VK0214 administered orally,
once daily for 28 days. The study also includes an evaluation of
the pharmacokinetics of VK0214 in AMN patients, as well as an
exploratory assessment of changes in plasma levels of very long
chain fatty acids.
The Phase 1b study
continues to enroll, and the company expects to complete enrollment
in 4Q23.
- Strong Quarter-End Cash Position of $376M. During the second quarter, Viking
closed a public offering of common stock, which raised gross
proceeds of $287.5 million,
significantly strengthening the company's cash position. As of the
end of the third quarter, the company held approximately
$376 million in cash, cash
equivalents, and marketable securities. These funds will support
the ongoing expansion of Viking's development pipeline, allowing
advancement of these programs through important clinical
milestones.
- Upcoming Investor Events. Viking management will
participate in the following upcoming investor events:
Truist Securities BioPharma
Symposium
New York,
NY
November 8 – 9,
2023
UBS Biopharma
Conference
Miami Beach,
FL
November 8 – 9,
2023
Stifel 2023 Healthcare
Conference
New York,
NY
November 14 – 15,
2023
Jefferies London Healthcare
Conference
London,
UK
November 14 – 16,
2023
Evercore ISI HealthCONx
Conference
Miami,
FL
November 28 – 30,
2023
Third Quarter and Nine Month Financial Highlights
Third Quarter Ended September 30,
2023 and 2022
Research and development expenses for the three months ended
September 30, 2023, were $18.4 million compared to $12.0 million for the same period in 2022.
The increase was primarily due to increased expenses related to
pre-clinical studies, clinical studies, stock-based compensation,
salaries and benefits and third-party consultants, partially offset
by decreased expenses related to manufacturing for drug
candidates.
General and administrative expenses for the three months ended
September 30, 2023, were $8.9 million compared to $4.2 million for the same period in 2022.
The increase was primarily due to increased expenses related to
legal and patent services, stock-based compensation, third-party
consultants and salaries and benefits.
For the three months ended September 30,
2023, Viking reported a net loss of $22.5 million, or $0.23 per share, compared to a net loss of
$15.8 million, or $0.21 per share, in the corresponding period in
2022. The increase in net loss for the three months ended
September 30, 2023, was primarily due
to the increase in research and development expenses and general
and administrative expenses, noted previously, partially offset by
increased interest income compared to the same period in 2022.
Nine Months Ended September 30,
2023 and 2022
Research and development expenses for the nine months ended
September 30, 2023, were $43.3 million compared to $38.1 million for the same period in 2022. The
increase was primarily due to increased expenses related to
preclinical studies, stock-based compensation, salaries and
benefits, manufacturing for drug candidates, regulatory service
costs and third-party consultants, partially offset by decreased
expenses related to clinical studies.
General and administrative expenses for the nine months ended
September 30, 2023, were $28.2 million compared to $12.0 million for the same period in 2022. The
increase was primarily due to increased expenses related to legal
and patent services, stock-based compensation, salaries and
benefits and third-party consultants.
For the nine months ended September 30,
2023, Viking reported a net loss of $61.3 million, or $0.66 per share, compared to a net loss of
$49.3 million, or $0.64 per share, in the corresponding period in
2022. The increase in net loss for the nine months ended
September 30, 2023, was primarily due
to the increase in research and development expenses and general
and administrative expenses, noted previously, partially offset by
increased interest income compared to the same period in 2022.
Balance Sheet as of September 30,
2023
At September 30, 2023, Viking held
cash, cash equivalents and short-term investments of $376 million, compared to $155.5 million as of December 31, 2022.
Conference Call
Management will host a conference call to discuss the company's
third quarter 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 1, 2023, by dialing (877)
344-7529 from the U.S. or (412) 317-0088 from outside the U.S. and
entering conference ID # 6033713. 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 first-in-class or
best-in-class therapies for the treatment of metabolic and
endocrine disorders, with three compounds currently in clinical
trials. 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 VK2735, a novel dual agonist of the
glucagon-like peptide 1 (GLP-1) and glucose-dependent
insulinotropic polypeptide (GIP) receptors for the potential
treatment of various metabolic disorders. Data from a Phase 1 trial
evaluating VK2735 (dosed subcutaneously) for metabolic disorders
demonstrated an encouraging safety and tolerability profile as well
as positive signs of clinical benefit. The company recently
initiated a Phase 2 study to evaluate VK2735 in patients with
obesity. The company also recently initiated a Phase 1 study
to evaluate an oral formulation of VK2735. In the rare disease
space, the company is 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 VK2809 and VK0214, 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 clinical and preclinical development programs and cash
resources. 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 VK2735, VK0214, VK2809, and the company's other incretin
receptor agonists; risks that prior clinical and preclinical
results may not be replicated; risks regarding regulatory
requirements; 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, 2022, 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. Consolidated Statements of Operations and
Comprehensive Loss
|
|
(In thousands,
except per share amounts) (Unaudited)
|
|
|
|
Three Months
Ended
September 30,
|
|
|
Nine Months
Ended
September 30,
|
|
|
|
2023
|
|
|
2022
|
|
|
2023
|
|
|
2022
|
|
Revenues
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
18,379
|
|
|
|
11,959
|
|
|
|
43,304
|
|
|
|
38,056
|
|
General and
administrative
|
|
|
8,886
|
|
|
|
4,237
|
|
|
|
28,238
|
|
|
|
12,016
|
|
Total operating
expenses
|
|
|
27,265
|
|
|
|
16,196
|
|
|
|
71,542
|
|
|
|
50,072
|
|
Loss from
operations
|
|
|
(27,265)
|
|
|
|
(16,196)
|
|
|
|
(71,542)
|
|
|
|
(50,072)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of
financing costs
|
|
|
(2)
|
|
|
|
(27)
|
|
|
|
(62)
|
|
|
|
(51)
|
|
Interest income,
net
|
|
|
4,733
|
|
|
|
450
|
|
|
|
10,314
|
|
|
|
857
|
|
Realized loss on
investments, net
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(42)
|
|
Total other income,
net
|
|
|
4,731
|
|
|
|
423
|
|
|
|
10,252
|
|
|
|
764
|
|
Net loss
|
|
|
(22,534)
|
|
|
|
(15,773)
|
|
|
|
(61,290)
|
|
|
|
(49,308)
|
|
Other comprehensive
loss, net of tax:
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss)
on securities
|
|
|
221
|
|
|
|
111
|
|
|
|
305
|
|
|
|
(813)
|
|
Foreign currency
translation loss
|
|
|
(86)
|
|
|
|
(223)
|
|
|
|
(108)
|
|
|
|
(399)
|
|
Comprehensive
loss
|
|
$
|
(22,399)
|
|
|
$
|
(15,885)
|
|
|
$
|
(61,093)
|
|
|
$
|
(50,520)
|
|
Basic and diluted net
loss per share
|
|
$
|
(0.23)
|
|
|
$
|
(0.21)
|
|
|
$
|
(0.66)
|
|
|
$
|
(0.64)
|
|
Weighted-average shares
used to compute basic
and diluted net loss per share
|
|
|
99,846
|
|
|
|
76,505
|
|
|
|
92,481
|
|
|
|
76,917
|
|
Viking Therapeutics,
Inc. Consolidated Balance Sheets
|
|
(In thousands,
except share and per share amounts)
|
|
|
|
September 30,
2023
|
|
|
December 31,
2022
|
|
|
|
(Unaudited)
|
|
|
|
|
Assets
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
37,185
|
|
|
$
|
36,632
|
|
Short-term investments
– available-for-sale
|
|
|
339,056
|
|
|
|
118,853
|
|
Prepaid clinical trial
and preclinical study costs
|
|
|
4,389
|
|
|
|
8,144
|
|
Prepaid expenses and
other current assets
|
|
|
670
|
|
|
|
3,411
|
|
Total current
assets
|
|
|
381,300
|
|
|
|
167,040
|
|
Right-of-use
assets
|
|
|
1,200
|
|
|
|
1,418
|
|
Deferred financing
costs
|
|
|
130
|
|
|
|
38
|
|
Deposits
|
|
|
33
|
|
|
|
33
|
|
Total
assets
|
|
$
|
382,663
|
|
|
$
|
168,529
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
5,711
|
|
|
$
|
8,529
|
|
Other accrued
liabilities
|
|
|
7,375
|
|
|
|
13,114
|
|
Lease liability,
current
|
|
|
319
|
|
|
|
304
|
|
Total current
liabilities
|
|
|
13,405
|
|
|
|
21,947
|
|
Lease liability, net
of current portion
|
|
|
1,018
|
|
|
|
1,260
|
|
Total long-term
liabilities
|
|
|
1,018
|
|
|
|
1,260
|
|
Total
liabilities
|
|
|
14,423
|
|
|
|
23,207
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
Preferred stock,
$0.00001 par value: 10,000,000 shares authorized at September 30,
2023 and December 31, 2022; no shares issued and outstanding at
September 30, 2023 and December 31, 2022
|
|
|
—
|
|
|
|
—
|
|
Common stock, $0.00001
par value: 300,000,000 shares authorized at September 30, 2023 and
December 31, 2022; 100,028,828 shares issued and outstanding at
September 30, 2023 and 78,257,258 shares issued and outstanding at
December 31, 2022
|
|
|
1
|
|
|
|
1
|
|
Treasury stock at
cost, 2,193,251 shares at September 30, 2023 and December 31,
2022
|
|
|
(6,795)
|
|
|
|
(6,795)
|
|
Additional paid-in
capital
|
|
|
729,278
|
|
|
|
445,267
|
|
Accumulated
deficit
|
|
|
(353,339)
|
|
|
|
(292,049)
|
|
Accumulated other
comprehensive loss
|
|
|
(905)
|
|
|
|
(1,102)
|
|
Total stockholders'
equity
|
|
|
368,240
|
|
|
|
145,322
|
|
Total liabilities and
stockholders' equity
|
|
$
|
382,663
|
|
|
$
|
168,529
|
|
View original content to download
multimedia:https://www.prnewswire.com/news-releases/viking-therapeutics-reports-third-quarter-2023-financial-results-and-provides-corporate-update-301967860.html
SOURCE Viking Therapeutics, Inc