PLYMOUTH MEETING, Pa.,
Nov. 10, 2014 /PRNewswire/ -- Inovio
Pharmaceuticals, Inc. (NASDAQ: INO) today reported financial
results for the quarter ended September 30,
2014.
Total revenue was $1.8 million and
$8.0 million for the three and nine
months ended September 30, 2014,
compared to $9.5 million and
$11.7 million for the same periods in
2013.
Total operating expenses were $10.2
million and $36.5 million for
the three and nine months ended September
30, 2014, compared to $8.7
million and $23.3 million for
the same periods in 2013.
The net loss attributable to common stockholders for the three
and nine months ended September 30,
2014, was $7.2 million, or
$0.12 per share, and $28.7 million, or $0.49 per share, compared to $30.9 million, or $0.64 per share, and $50.6
million, or $1.15 per share,
for the same periods in 2013.
The $23.7 million and $21.9 million decrease in net loss attributable
to common stockholders for the three and nine months ended
September 30, 2014, compared with the
same periods in 2013 resulted primarily from a higher non-cash
accounting expense in 2013 related to the change in fair value of
common stock warrants based on a required quarterly mark to market
adjustment to reflect changes in the Company's stock price, which
increased significantly during 2013.
Revenue
We are receiving ongoing revenue for payments received from
Roche under our ongoing collaborative research and development
arrangement. The decrease in revenue for the comparable periods was
primarily due to the large up-front payment associated with the
partnership agreement concluded with Roche in 3Q 2013.
Operating Expenses
Research and development expenses for the three and nine months
ended September 30, 2014, were
$7.0 million and $24.9 million, compared to $5.4 million and $15.0
million for the same periods in 2013. The increase for the
three and nine month periods was primarily related to work
conducted under our Roche partnership and expenses relating to
preparations for future clinical trials. General and administrative
expenses for the three and nine months ended September 30, 2014, were $3.2 million and $11.6
million versus $3.3 million
and $9.3 million for the same periods
in 2013. Increased non-cash stock-based compensation also
contributed to the overall increase in operating expenses.
Capital Resources
As of September 30, 2014, cash and
cash equivalents and short-term investments were $100.9 million compared with $52.7 million as of December 31, 2013. This
increase was primarily due to the net proceeds from our
March 2014 financing and warrants and
options exercised during the period.
As of September 30, 2014, the
company had 60.5 million shares outstanding and 66.6 million fully
diluted.
Based on management's projections and analysis, the Company
believes that cash, cash equivalents and short-term investments are
sufficient to meet its planned working capital requirements through
the end of 2017, excluding its planned phase III clinical trial of
VGX-3100. The Company expects to raise additional capital to fund
this study.
Inovio's balance sheet and statement of operations is provided
below. Form 10-Q providing the complete 2014 third quarter
financial report can be found at:
http://ir.inovio.com/secfilings.
Corporate Update
Clinical Development
In the third quarter, Inovio released top line efficacy data
from its randomized, placebo-controlled, double-blind phase II
clinical trial (HPV-003) for VGX-3100, its SynCon®
immunotherapy against HPV-caused pre-cancers and cancers delivered
with its CELLECTRA® electroporation device. The primary
endpoint, histologic regression, was evaluated 36 weeks after the
first treatment. In the per protocol analysis of this
three-immunization regimen, CIN2/3 resolved to CIN1 or no disease
in 53 of 107 (49.5%) women treated with VGX-3100 compared to 11 of
36 (30.6%) who received placebo. This difference was statistically
significant (p<0.025). Intent to treat results were also
statistically significant. There was also a high level of complete
CIN 2/3 clearance.
This trial also demonstrated virological clearance of HPV 16 or
18 from the cervix in conjunction with histopathological regression
of cervical dysplasia to CIN1 or no disease, a secondary endpoint
of the trial, in 43 of 107 (40.2%) VGX-3100 recipients compared to
5 of 35 (14.3%) placebo recipients (p<0.025). Robust T-cell
activity was detected in subjects who received VGX-3100 compared to
those who received placebo.
Detailed study findings will be submitted for publication in a
peer-reviewed medical journal. Inovio plans to independently
advance VGX-3100 into a phase III registration study with target
patient characteristics and a treatment regimen similar to the
phase II study. The Company expects to complete its end-of-phase-II
meeting with the FDA in 2015 and begin treating women in a phase
III study in early 2016.
Inovio has broadened its therapeutic HPV franchise to include
other precancers caused by HPV infection such as vulvar, vaginal,
and other anogenital neoplasia as well as cancers of the cervix,
head & neck, and anogenital areas. Inovio is conducting phase
I/IIa clinical studies of VGX-3100 against HPV-caused cervical
cancer and head and neck cancer. Both of these studies incorporate
an immune activator, DNA-based IL-12, which has been shown to
further boost already high levels of antigen-specific T cells
generated by the immunotherapy. This combination is designated
INO-3112.
Further expanding its HPV portfolio, Inovio launched a
compassionate phase I clinical trial in patients with HPV-caused
aerodigestive cancer. This study is testing Inovio's immunotherapy,
INO-3106, alone or in combination with DNA-based IL-12 in subjects
with HPV-6 associated invasive aerodigestive malignancies who have
exhausted other treatment options (chemotherapy, radiation and
surgery). Successful results could open a path to pursuing an FDA
orphan designation (special status granted for therapies for rare
diseases) for aerodigestive cancers.
Inovio plans to initiate an exploratory human study for
INO-1400, its hTERT DNA immunotherapy, for breast, lung and
pancreatic cancers by the end of 2014. hTERT is over-expressed in
85% of cancers. As a result, this immunotherapy has the potential
to serve as a "universal" immune therapeutic agent for cancer.
INO-1400 represents the first of several new broadly applicable
cancer-specific antigens in Inovio's growing oncology product
development pipeline that we intend to advance into human
studies.
In collaboration with Roche, Inovio expects to advance its
prostate cancer immunotherapy, INO-5150, into a phase Ia/Ib
clinical trial in 2015 in patients with castrate resistant prostate
cancer. The study will assess a comprehensive set of parameters and
combinations of (i) INO-5150, (ii) additional new prostate cancer
antigens that the team has been developing under the Roche/Inovio
research collaboration, and (iii) Roche's portfolio of
immunomodulatory drugs including checkpoint inhibitors. The
initiation of this trial will trigger a milestone payment from
Roche.
Also in collaboration with Roche, Inovio intends to launch a
phase I/IIa clinical trial for its hepatitis B immunotherapy,
INO-1800, in early 2015. The initiation of this trial will also
trigger a milestone payment from Roche.
Inovio's multi-antigen SynCon® immunotherapy
targeting hepatitis C virus, INO-8000 (a.k.a. VGX-6500) is being
studied in a phase I/IIa clinical trial in Korea in collaboration
with GeneOne Life Sciences, Inc. The companies expect to report
phase I data from this clinical trial in 2015. Inovio intends to
launch a related multi-site study with INO-8000 in the US.
Inovio expects to initiate a phase I study for its global,
multi-clade PENNVAX®-GP preventive and therapeutic HIV
DNA vaccine candidate. Development of this product was funded in
part by a $25 million NIH contract.
Initiation of this study may be delayed from the 4Q 2014 to 1Q
2015.
Inovio published positive animal data from its Ebola DNA
immunotherapy in 2013. In 3Q 2014 we announced our intent to
advance this immunotherapy (INO-4200), which is designed to target
multiple strains of Ebola, in a phase I clinical trial in the first
half of 2015 in collaboration with GeneOne Life Sciences, Inc.
(Inovio owns a minority share interest in GeneOne). Upon successful
completion of the phase I trial, the companies will jointly seek
additional third party support and resources to further develop and
commercialize this product.
Preclinical Development
In the third quarter, data was published from a study of
Inovio's DNA immunotherapy for C. difficile, a bacterial infection
that causes severe intestinal distress and symptoms such as
diarrhea, nausea, colitis, sepsis, and even death. This immune
therapy, delivered with electroporation, produced high levels of
neutralizing antibodies that protected 100% of mice and non-human
primates from a lethal dose of C. difficile toxin. The data was
published in Infection and Immunity in a paper titled, "An
Optimized, Synthetic DNA Vaccine Encoding the Toxin A and Toxin B
Receptor Binding Domains of Clostridium difficile Induces
Protective Antibody Responses In Vivo." This vaccine is being
tested in collaboration with Dr. Michele
Kutzler at Drexel University.
Clostridium difficile infection is a major source of morbidity and
mortality in the US, with half a million cases and
approximately 30,000 deaths annually and a significant related
healthcare cost.
Corporate Development
Subsequent to the quarter, the Defense Advanced Research
Projects Agency (DARPA) awarded $12.2
million for a collaborative study that will be conducted by
scientists from the Perelman School of Medicine at the University of Pennsylvania; Inovio Pharmaceuticals;
and MedImmune, the global biologics research and development arm of
AstraZeneca. Together, the group will develop and assess DNA-based
monoclonal antibodies (mAbs) for influenza and antibiotic resistant
bacteria. This collaboration aims to demonstrate that the DNA
plasmids containing optimized DNA sequences encoded to generate
disease-specific mAbs can activate sufficient quantities of
specific antibodies in the body to be protective against a pathogen
challenge. Successful completion of the initial preclinical
activities under the DARPA grant will lead to clinical studies on
selected product candidates to be funded under a future increment
to the award.
Inovio transferred its U.S. stock exchange listing from the NYSE
MKT to the NASDAQ Global Select Market on September 15, 2014, retaining the trading symbol
INO. During the quarter, Inovio was added to the Russell Global,
Russell 2000® and Russell Microcap®
Indexes.
Adding to the breadth of Inovio's management team, Ms.
Jennifer Laux was appointed
Vice President, Commercial Development. She is responsible for
developing Inovio's commercialization strategy for its growing
portfolio of oncology and infectious disease DNA immunotherapies.
Ms. Laux has over 20 years of experience in life sciences marketing
and served in senior cardiovascular marketing roles for Boehringer
Ingelheim and Merck. She holds an MBA in Marketing from the
Wharton School, an MA in International Studies from
the University of Pennsylvania, and a BA in International
Relations from Georgetown
University.
Inovio continues to work toward partnerships with other large
pharmaceutical companies interested in Inovio SynCon®
immunotherapy and vaccine products.
About Inovio Pharmaceuticals, Inc.
Inovio is revolutionizing the fight against cancer and
infectious diseases. Our immunotherapies uniquely activate
best-in-class immune responses to prevent and treat disease, and
have shown clinically significant efficacy with a favorable safety
profile. With an expanding portfolio of immune therapies, the
company is advancing a growing preclinical and clinical stage
product pipeline. Partners and collaborators include Roche,
University of Pennsylvania, NIH, HIV
Vaccines Trial Network, National Cancer Institute, U.S.
Military HIV Research Program, and University of
Manitoba. For more information, visit www.inovio.com.
This press release contains certain forward-looking
statements relating to our business, including our plans to develop
electroporation-based drug and gene delivery technologies and DNA
vaccines and our capital resources. Actual events or results may
differ from the expectations set forth herein as a result of a
number of factors, including uncertainties inherent in pre-clinical
studies, clinical trials and product development programs
(including, but not limited to, the fact that pre-clinical and
clinical results referenced in this release may not be indicative
of results achievable in other trials or for other indications,
that the studies or trials may not be successful or achieve the
results desired, including safety and efficacy for VGX-3100, that
pre-clinical studies and clinical trials may not commence or be
completed in the time periods anticipated, that results from one
study may not necessarily be reflected or supported by the results
of other similar studies and that results from an animal study may
not be indicative of results achievable in human studies), the
availability of funding to support continuing research and studies
in an effort to prove safety and efficacy of electroporation
technology as a delivery mechanism or develop viable DNA vaccines,
our ability to support our broad pipeline of SynCon®
active immune therapy and vaccine products, the adequacy of our
capital resources, the availability or potential availability of
alternative therapies or treatments for the conditions targeted by
the company or its collaborators, including alternatives that may
be more efficacious or cost-effective than any therapy or treatment
that the company and its collaborators hope to develop, evaluation
of potential opportunities, issues involving product liability,
issues involving patents and whether they or licenses to them will
provide the company with meaningful protection from others using
the covered technologies, whether such proprietary rights are
enforceable or defensible or infringe or allegedly infringe on
rights of others or can withstand claims of invalidity and whether
the company can finance or devote other significant resources that
may be necessary to prosecute, protect or defend them, the level of
corporate expenditures, assessments of the company's technology by
potential corporate or other partners or collaborators, capital
market conditions, the impact of government healthcare proposals
and other factors set forth in our Annual Report on Form 10-K
for the year ended December 31, 2013, our Form 10-Q for the
quarter ended September 30, 2014, and
other regulatory filings from time to time. There can be no
assurance that any product in Inovio's pipeline will be
successfully developed or manufactured, that final results of
clinical studies will be supportive of regulatory approvals
required to market licensed products, or that any of the
forward-looking information provided herein will be proven
accurate.
INOVIO
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(Unaudited)
|
|
|
|
|
|
September 30,
2014
|
|
December 31,
2013
|
|
(Unaudited)
|
|
|
|
ASSETS
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
70,669,000
|
|
|
$
|
33,719,796
|
|
Short-term
investments
|
30,259,285
|
|
|
18,905,608
|
|
Accounts
receivable
|
1,621,994
|
|
|
3,301,563
|
|
Prepaid expenses and
other current assets
|
542,006
|
|
|
637,433
|
|
Prepaid expenses and
other current assets from affiliated entity
|
1,482,487
|
|
|
2,057,350
|
|
Deferred tax
asset
|
61,839
|
|
|
61,839
|
|
Total current
assets
|
104,636,611
|
|
|
58,683,589
|
|
Restricted
cash
|
—
|
|
|
100,762
|
|
Fixed assets,
net
|
4,634,058
|
|
|
2,886,545
|
|
Investment in
affiliated entity
|
8,998,375
|
|
|
9,664,587
|
|
Intangible assets,
net
|
5,006,658
|
|
|
5,718,778
|
|
Goodwill
|
10,113,371
|
|
|
10,113,371
|
|
Common stock
warrants
|
591,000
|
|
|
717,500
|
|
Other
assets
|
552,459
|
|
|
402,075
|
|
Total
assets
|
$
|
134,532,532
|
|
|
$
|
88,287,207
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
Accounts payable and
accrued expenses
|
$
|
4,698,161
|
|
|
$
|
5,444,508
|
|
Accounts payable and
accrued expenses due to affiliated entity
|
94,250
|
|
|
522,255
|
|
Accrued clinical
trial expenses
|
1,259,690
|
|
|
1,446,180
|
|
Common stock
warrants
|
2,207,388
|
|
|
19,540,583
|
|
Deferred
revenue
|
254,542
|
|
|
1,624,388
|
|
Deferred revenue from
affiliated entity
|
413,541
|
|
|
388,542
|
|
Total current
liabilities
|
8,927,572
|
|
|
28,966,456
|
|
Deferred revenue, net
of current portion
|
2,898,775
|
|
|
1,997,333
|
|
Deferred revenue from
affiliated entity, net of current portion
|
930,444
|
|
|
1,211,694
|
|
Deferred
rent
|
4,535,722
|
|
|
3,013,263
|
|
Deferred tax
liabilities
|
195,778
|
|
|
195,778
|
|
Total
liabilities
|
17,488,291
|
|
|
35,384,524
|
|
Inovio
Pharmaceuticals, Inc. stockholders' equity:
|
|
|
|
|
|
Common
stock
|
60,458
|
|
|
52,577
|
|
Additional paid-in
capital
|
441,281,144
|
|
|
348,267,389
|
|
Accumulated
deficit
|
(324,498,886)
|
|
|
(295,788,577)
|
|
Accumulated other
comprehensive loss
|
(110,176)
|
|
|
(76,365)
|
|
Total Inovio
Pharmaceuticals, Inc. stockholders' equity
|
116,732,540
|
|
|
52,455,024
|
|
Non-controlling
interest
|
311,701
|
|
|
447,659
|
|
Total stockholders'
equity
|
117,044,241
|
|
|
52,902,683
|
|
Total liabilities
and stockholders' equity
|
$
|
134,532,532
|
|
|
$
|
88,287,207
|
|
INOVIO
PHARMACEUTICALS, INC
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
|
|
|
|
|
|
Three Months
Ended
September 30,
|
|
Nine Months
Ended
September 30,
|
|
2014
|
|
2013
|
|
2014
|
|
|
2013
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
Revenue under
collaborative research and development arrangements
|
$
|
1,114,952
|
|
|
$
|
8,388,760
|
|
|
$
|
5,658,460
|
|
|
$
|
8,417,330
|
|
Revenue under
collaborative research and development arrangements with affiliated
entity
|
112,500
|
|
|
106,250
|
|
|
366,964
|
|
|
318,750
|
|
Grants and
miscellaneous revenue
|
612,901
|
|
|
991,835
|
|
|
1,974,234
|
|
|
2,991,600
|
|
Total
revenues
|
1,840,353
|
|
|
9,486,845
|
|
|
7,999,658
|
|
|
11,727,680
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
7,017,805
|
|
|
5,438,405
|
|
|
24,850,566
|
|
|
14,964,599
|
|
General and
administrative
|
3,153,714
|
|
|
3,282,796
|
|
|
11,633,259
|
|
|
9,303,535
|
|
Gain on sale of
assets
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,000,000)
|
|
Total operating
expenses
|
10,171,519
|
|
|
8,721,201
|
|
|
36,483,825
|
|
|
23,268,134
|
|
Income (Loss) from
operations
|
(8,331,166)
|
|
|
765,644
|
|
|
(28,484,167)
|
|
|
(11,540,454)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other
income, net
|
97,174
|
|
|
46,787
|
|
|
218,249
|
|
|
123,638
|
|
Change in fair value
of common stock warrants
|
(113,980)
|
|
|
(34,952,210)
|
|
|
204,484
|
|
|
(39,579,704)
|
|
Gain (Loss) on
investment in affiliated entity
|
1,168,911
|
|
|
3,248,926
|
|
|
(666,212)
|
|
|
380,791
|
|
Net
loss
|
(7,179,061)
|
|
|
(30,890,853)
|
|
|
(28,727,646)
|
|
|
(50,615,729)
|
|
Net loss attributable
to non-controlling interest
|
1,486
|
|
|
13,443
|
|
|
17,337
|
|
|
41,611
|
|
Net loss
attributable to Inovio Pharmaceuticals, Inc.
|
$
|
(7,177,575)
|
|
|
$
|
(30,877,410)
|
|
|
$
|
(28,710,309)
|
|
|
$
|
(50,574,118)
|
|
Net loss per
common share attributable to Inovio Pharmaceuticals, Inc.
stockholders:
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
$
|
(0.12)
|
|
|
$
|
(0.64)
|
|
|
$
|
(0.49)
|
|
|
$
|
(1.15)
|
|
Diluted
|
$
|
(0.12)
|
|
|
$
|
(0.64)
|
|
|
$
|
(0.52)
|
|
|
$
|
(1.15)
|
|
Weighted average
number of common shares outstanding used in per share
calculations:
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
60,392,911
|
|
|
47,989,039
|
|
|
58,625,740
|
|
|
44,045,769
|
|
Diluted
|
60,602,831
|
|
|
47,989,039
|
|
|
58,936,414
|
|
|
44,045,769
|
|
CONTACTS:
Investors: Bernie
Hertel, Inovio Pharmaceuticals, 858-410-3101,
bhertel@inovio.com
Media: Jeff Richardson, Inovio
Pharmaceuticals, 267-440-4211, jrichardson@inovio.com
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SOURCE Inovio Pharmaceuticals, Inc.