Conference call scheduled for 4:30 p.m. ET today
- Reported Positive Top-Line Results from Phase 2b VOYAGE Study of VK2809 in Patients with
Biopsy-Confirmed NASH, Showing up to 55% Median Liver Fat
Reduction; 52 Week Biopsy Results Expected 1H24
- Phase 2 Study of Dual GLP-1/GIP Agonist VK2735 in Obesity
Planned for 3Q23
- Phase 1 Trial of Oral VK2735 Ongoing; Results Expected
4Q23
- Strong Quarter-End Cash Position of $393M
SAN
DIEGO, July 26, 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 second quarter and six months ended
June 30, 2023, and provided an update
on its clinical pipeline and other corporate developments.
Highlights from the Quarter Ended June
30, 2023, and Other Recent Events:
"In the second quarter of 2023 Viking continued to build on the
momentum achieved in the first quarter, following the successful
Phase 1 results of the dual incretin receptor agonist VK2735 for
obesity," stated Brian Lian, Ph.D.,
chief executive officer of Viking. "During the second quarter, we
reported top-line data from our Phase 2b VOYAGE study of VK2809 in patients with
biopsy-confirmed NASH and fibrosis. The results demonstrated
robust efficacy on the primary endpoint of reduction in liver fat
at 12 weeks, and reaffirmed prior data showing VK2809's promising
tolerability and safety profile. We remain on track to report
the histology data from VOYAGE in the first half of 2024.
With our lead obesity candidate, VK2735, we expect to initiate a
Phase 2 trial later this quarter, and report results in the first
half of 2024. In addition, the Phase 1 trial of our novel
oral formulation of VK2735 continues to enroll, and we expect to
report the initial results from this study later this year.
We ended the second quarter with approximately $393 million, placing us in a strong financial
position, with runway to execute through multiple potential
value-creating events."
Pipeline and Recent Corporate Highlights
- Reported Positive Top-Line Results from Phase 2b VOYAGE Study of VK2809 in Patients with
Biopsy-Confirmed NASH. 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 its Phase 2b VOYAGE study evaluating VK2809 in patients
with biopsy-confirmed non-alcoholic steatohepatitis (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, 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.
The VOYAGE data thus far support previous findings indicating
that VK2809 may offer a cardio-protective benefit.
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 gastrointestinal (GI) tolerability, with
rates of nausea, diarrhea, stool frequency, and vomiting similar
among VK2809-treated patients compared to placebo.
The top-line Phase 2b VOYAGE findings support the company's belief
that VK2809's broad lipid-lowering properties, combined with its
safety, excellent tolerability, significant liver-fat reduction,
and oral route of administration, establish it as a best-in-class
therapeutic for the treatment of NASH. 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.
- Initiation of Phase 2 Study of VK2735 in Obese Patients
Planned for 3Q23 Following Positive Phase 1 Data Demonstrating
Significant Weight Loss, Promising Safety and
Tolerability. 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,
NASH, and certain rare disorders. Initial in vivo data
from the company's dual agonist program demonstrated improvements
in weight loss, glucose control and insulin sensitivity among
diet-induced obese mice following treatment with Viking's compounds
as compared to a GLP-1 mono-agonist, when administered at the same
dose for the same period of time. VK2735-treated animals also
demonstrated reductions in liver fat content that were generally
larger than those observed among animals treated with a GLP-1
mono-agonist.
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 addition, treatment with VK2735 led to mean
weight loss of up to 18 pounds from baseline.
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, a Tmax (time to reach maximum
plasma concentration) ranging from approximately 75 to 90 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.
Importantly, VK2735 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 GI-related adverse events (99%) were
also reported as mild or moderate. No subjects were
discontinued for nausea, vomiting, or GI adverse events.
Notably, despite robust activation of the incretin receptor
pathways, no hypoglycemia was reported. The company
believes that the tolerability data from this study indicate that
higher doses may be achieved with longer titration windows.
Further dose escalation is planned in future clinical studies.
Based on these positive results, the company
plans to initiate a Phase 2 study of VK2735 in patients with
obesity in 3Q23.
- Phase 1 Trial Evaluating Novel Oral Formulation of VK2735
Continues to Enroll; Data Expected in
2H23. During the first quarter of 2023,
concurrent with the announcement of results from the Phase 1 trial
of the subcutaneous injectable formulation of VK2735, Viking
announced the initiation of 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.
This study, which is an extension of the SAD/MAD
Phase 1 trial for VK2735 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 plasma glucose.
The company expects to report the initial data
from the oral formulation Phase 1 study in 4Q23.
- 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.
In 2021, Viking announced the results from a
Phase 1 study of VK0214 in healthy volunteers. The study
successfully achieved its primary and secondary endpoints as VK0214
demonstrated 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. AMN is the most common form of X-ALD, affecting
approximately 50% of those with the disease. 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.
This Phase 1b
study continues to enroll, and the company expects to complete
enrollment in 2H23.
- Closed Successful Offering of Common Stock, Raising Gross
Proceeds of Approximately $288
Million. In 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 second quarter, the company held approximately $393 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.
Second Quarter and Six Month Financial Highlights
Second Quarter Ended June 30,
2023 and 2022
Research and development expenses for the three months ended
June 30, 2023, were $13.9 million compared to $13.5 million for the same period in 2022.
The increase was primarily due to increased expenses related to
pre-clinical studies, manufacturing for the company's drug
candidates, stock-based compensation, salaries and benefits and
third-party consultants, partially offset by decreased expenses
related to clinical studies.
General and administrative expenses for the three months ended
June 30, 2023, were $9.8 million compared to $4.1 million for the same period in 2022.
The increase was primarily due to increased expenses related to
legal and patent services, stock-based compensation and salaries
and benefits.
For the three months ended June 30,
2023, Viking reported a net loss of $19.2 million, or $0.19 per share, compared to a net loss of
$17.4 million, or $0.23 per share, in the corresponding period in
2022. The increase in net loss for the three months ended
June 30, 2023, was primarily due to
the increase in general and administrative expenses, noted
previously, partially offset by increased interest income compared
to the same period in 2022.
Six Months Ended June 30, 2023
and 2022
Research and development expenses for the six
months ended June 30, 2023, were
$24.9 million compared to
$26.1 million for the same period in
2022. The decrease was primarily due to decreased expenses related
to clinical studies, partially offset by increased expenses related
to manufacturing for the company's drug candidates, stock-based
compensation, salaries and benefits and regulatory services.
General and administrative expenses for the six months ended
June 30, 2023, were $19.4 million compared to $7.8 million for the same period in 2022. The
increase was primarily due to increased expenses related to legal
and patent services, stock-based compensation, and salaries and
benefits.
For the six months ended June 30,
2023, Viking reported a net loss of $38.8 million, or $0.44 per share, compared to a net loss of
$33.5 million, or $0.43 per share, in the corresponding period in
2022. The increase in net loss for the six months ended
June 30, 2023, was primarily due to
the increase in general and administrative expenses, noted
previously, partially offset by increased interest income compared
to the same period in 2022.
Balance Sheet as of June 30,
2023
At June 30, 2023, Viking held
cash, cash equivalents and short-term investments of $392.9 million, compared to $155.5 million as of December 31, 2022.
Conference Call
Management will host a conference call to discuss the company's
second 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
August 2, 2023, by dialing (877)
344-7529 from the U.S. or (412) 317-0088 from outside the U.S. and
entering conference ID # 7363621. 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 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
June
30,
|
|
|
Six Months
Ended
June
30,
|
|
|
|
2023
|
|
|
2022
|
|
|
2023
|
|
|
2022
|
|
Revenues
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
13,917
|
|
|
|
13,542
|
|
|
|
24,925
|
|
|
|
26,097
|
|
General and
administrative
|
|
|
9,823
|
|
|
|
4,089
|
|
|
|
19,352
|
|
|
|
7,779
|
|
Total operating
expenses
|
|
|
23,740
|
|
|
|
17,631
|
|
|
|
44,277
|
|
|
|
33,876
|
|
Loss from
operations
|
|
|
(23,740)
|
|
|
|
(17,631)
|
|
|
|
(44,277)
|
|
|
|
(33,876)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of
financing costs
|
|
|
(32)
|
|
|
|
(12)
|
|
|
|
(60)
|
|
|
|
(24)
|
|
Interest income,
net
|
|
|
4,547
|
|
|
|
253
|
|
|
|
5,581
|
|
|
|
407
|
|
Realized loss on
investments, net
|
|
|
—
|
|
|
|
(42)
|
|
|
|
—
|
|
|
|
(42)
|
|
Total other income,
net
|
|
|
4,515
|
|
|
|
199
|
|
|
|
5,521
|
|
|
|
341
|
|
Net loss
|
|
|
(19,225)
|
|
|
|
(17,432)
|
|
|
|
(38,756)
|
|
|
|
(33,535)
|
|
Other comprehensive
loss, net of tax:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss)
on securities
|
|
|
(417)
|
|
|
|
(31)
|
|
|
|
84
|
|
|
|
(924)
|
|
Foreign currency
translation loss
|
|
|
(5)
|
|
|
|
(207)
|
|
|
|
(22)
|
|
|
|
(176)
|
|
Comprehensive
loss
|
|
$
|
(19,647)
|
|
|
$
|
(17,670)
|
|
|
$
|
(38,694)
|
|
|
$
|
(34,635)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
|
$
|
(0.19)
|
|
|
$
|
(0.23)
|
|
|
$
|
(0.44)
|
|
|
$
|
(0.43)
|
|
Weighted-average shares
used to compute basic and diluted net loss per share
|
|
|
99,010
|
|
|
|
76,842
|
|
|
|
88,738
|
|
|
|
77,126
|
|
Viking Therapeutics,
Inc.
Consolidated Balance
Sheets
(In thousands,
except share and per share amounts)
|
|
|
|
June 30,
2023
|
|
|
December 31,
2022
|
|
|
|
(Unaudited)
|
|
|
|
|
Assets
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
69,519
|
|
|
$
|
36,632
|
|
Short-term investments
– available for sale
|
|
|
323,401
|
|
|
|
118,853
|
|
Prepaid clinical trial
and preclinical study costs
|
|
|
5,491
|
|
|
|
8,144
|
|
Prepaid expenses and
other current assets
|
|
|
960
|
|
|
|
3,411
|
|
Total current
assets
|
|
|
399,371
|
|
|
|
167,040
|
|
Right-of-use
assets
|
|
|
1,273
|
|
|
|
1,418
|
|
Deferred financing
costs
|
|
|
16
|
|
|
|
38
|
|
Deposits
|
|
|
33
|
|
|
|
33
|
|
Total
assets
|
|
$
|
400,693
|
|
|
$
|
168,529
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
5,611
|
|
|
$
|
8,529
|
|
Other accrued
liabilities
|
|
|
7,553
|
|
|
|
13,114
|
|
Lease liability,
current
|
|
|
314
|
|
|
|
304
|
|
Total current
liabilities
|
|
|
13,478
|
|
|
|
21,947
|
|
Lease liability, net
of current portion
|
|
|
1,100
|
|
|
|
1,260
|
|
Total long-term
liabilities
|
|
|
1,100
|
|
|
|
1,260
|
|
Total
liabilities
|
|
|
14,578
|
|
|
|
23,207
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
Preferred stock,
$0.00001 par value: 10,000,000 shares authorized at
June 30, 2023 and
December 31, 2022; no shares issued and outstanding
at June 30, 2023 and
December 31, 2022
|
|
|
—
|
|
|
|
—
|
|
Common stock, $0.00001
par value: 300,000,000 shares authorized at
June 30, 2023 and
December 31, 2022; 100,028,828 shares issued and
outstanding at June
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 June 30, 2023 and December 31,
2022
|
|
|
(6,795)
|
|
|
|
(6,795)
|
|
Additional paid-in
capital
|
|
|
724,754
|
|
|
|
445,267
|
|
Accumulated
deficit
|
|
|
(330,805)
|
|
|
|
(292,049)
|
|
Accumulated other
comprehensive loss
|
|
|
(1,040)
|
|
|
|
(1,102)
|
|
Total stockholders'
equity
|
|
|
386,115
|
|
|
|
145,322
|
|
Total liabilities and
stockholders' equity
|
|
$
|
400,693
|
|
|
$
|
168,529
|
|
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SOURCE Viking Therapeutics, Inc.