BLUE BELL, Pa., March 17, 2014 /PRNewswire/ -- Inovio
Pharmaceuticals, Inc. (NYSE MKT: INO) today reported financial
results for the fourth quarter and year ended December 31, 2013.
Total revenue was $1.7 million and
$13.5 million for the quarter and
year ended December 31, 2013, as
compared to $1.1 million and
$4.1 million for the same periods in
2012.
Total operating expenses for the quarter and year and ended
December 31, 2013, were $9.7 million and $33.0
million as compared to $7.4
million and $27.6 million for
the same periods in 2012.
The loss from operations prior to other income (expenses) for
the quarter and year ended December 31,
2013, was $8.0 million, or
$0.04 per share, and $19.5 million, or $0.11 per share, as compared with $6.2 million, or $0.04 per share, and $23.5
million, or $0.17 per share,
for the quarter and year ended December 31,
2012.
The net loss attributable to common stockholders for the quarter
and year ended December 31, 2013, was
$15.5 million, or $0.07 per share, and $66.0
million, or $0.36 per share,
as compared with a net loss attributable to common stockholders of
$659,000, or $0.00 per share, and $19.7
million, or $0.14 per share,
for the quarter and year ended December 31,
2012.
The $14.8 million and $46.4 million increase in net loss attributable
to common stockholders for the quarter and year ended December 31, 2013, compared with the same periods
in 2012, resulted primarily from a non-cash accounting expense
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 the year.
Dr. J. Joseph Kim, Inovio's
President and CEO, said, "By all measures, 2013 was a prolific year
for Inovio. We reported data reinforcing our claim to best-in-class
T cell immune responses among active immunotherapies. We concluded
a valuable and technically validating partnership with a leading
oncology company, Roche. We announced multiple cancer and
infectious disease product advancements. Subsequent to year end, we
closed the largest financing in the company's history with highly
respected institutional biotechnology investors, extending our
operating runway through 2017 and allowing us to proactively
advance various product and technology programs. We look forward to
the phase II efficacy and immune response data we will release
mid-year. In terms of our technology, product pipeline, people, and
capital resources, we are well-positioned and our team is working
hard to create another year of important strides."
Revenue
The increase in revenue for the annual period was primarily due
to $9.2 million of revenue recognized
from our agreement with Roche. This revenue from Roche consisted of
an amortized portion of their upfront payment plus development fees
paid for work conducted by Inovio in Q4.
Operating Expenses
Research and development expenses for the quarter and year ended
December 31, 2013, were $6.4 million and $21.4
million as compared to $4.4
million and $18.0 million for
the same periods in 2012. General and administrative expenses for
the quarter and year ended December 31,
2013, were $4.3 million and
$13.6 million, compared to
$2.9 million and $10.8 million for the quarter and year ended
December 31, 2012.
Capital Resources
As of December 31, 2013, cash and
cash equivalents plus short-term investments were $52.6 million compared with $13.7 million as of December 31, 2012.
On March 7, 2013, the Company closed an underwritten
offering of 27,377,266 shares of common stock and warrants to
purchase an aggregate of up to 13,688,633 shares of common stock.
The shares and warrants were sold in units at a price of
$0.55 per unit, with each unit
consisting of one share of common stock and a warrant to purchase
0.5 shares of common stock at an exercise price of $0.7936 per share.
During the year ended December 31,
2013, the Company sold 15,700,668 shares of common stock
under its ATM common stock sales agreement for net proceeds of
$18.9 million, with an average price
of $1.24 per share. We have exhausted
all available proceeds under this ATM agreement and this agreement
is now terminated. Warrants and stock options to purchase
23,090,211 shares of common stock were exercised for total proceeds
to the Company of $19.8 million.
As of December 31, 2013, the
company had 210.3 million shares outstanding and 240.9 million
fully diluted.
Subsequent to the quarter, the exercise of warrants and stock
options amounted to 7,519,039 shares, with total proceeds to the
Company of $10.1 million.
On March 4, 2014, the Company
closed an underwritten public offering of 21,810,900 shares of the
Company's common stock, including 2,844,900 shares of common stock
issued pursuant to the underwriter's exercise of its overallotment
option, at a price of $2.90 per
share. The gross proceeds of this offering were approximately
$63.3 million. Net proceeds to the
Company, after deducting the underwriter's discounts and commission
and other estimated offering expenses payable by the Company, were
approximately $59.2 million.
As of March 7, 2014, the company
had 239.6 million shares outstanding.
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.
Inovio's balance sheet and statement of operations are provided
below. Form 10-K providing the complete 2013 annual financial
report can be found at: http://ir.inovio.com/secfilings.
Corporate Update
Corporate Development
In a major corporate development for the Company, Roche and
Inovio entered into an exclusive worldwide license agreement to
research, develop and commercialize Inovio's highly-optimized,
multi-antigen DNA vaccine products targeting prostate cancer and
hepatitis B. Roche licensed Inovio's therapeutic vaccines INO-5150
for prostate cancer and INO-1800 for hepatitis B as well as the use
of Inovio's CELLECTRA® electroporation technology for
delivery of these vaccines. Roche also obtained an option to
license additional vaccine candidates for prostate cancer in
connection with a funded collaborative research program.
Roche agreed to an upfront payment to Inovio of $10 million (paid in the fourth quarter), will
pay all preclinical and clinical development costs for these
products, and will make milestone payments potentially up to
$412.5 million upon reaching certain
development and commercial milestones for INO-5150 and INO-1800.
Additional development milestone payments could be made to us if
Roche pursues other indications with INO-5150 or INO-1800. Inovio
is entitled to receive up to double-digit tiered royalties on
product sales.
Inovio has continuing discussions with other large
pharmaceutical companies interested in potential strategic
partnerships to advance the development of Inovio's numerous
SynCon® immunotherapy and vaccine products.
Inovio and the U.S. Army Medical Research Institute of
Infectious Diseases (USAMRIID) received a $3.5 million grant from the National Institute of
Allergy and Infectious Diseases (NIAID) to advance the development
of Inovio's next generation DNA vaccine delivery device capable of
simultaneously administering multiple synthetic vaccines via skin
surface electroporation.
Inovio was recognized with Vaccine Industry Excellence (ViE)
Awards for "Best Early Stage Biotech" and "Best Therapeutic
Vaccine," for its HPV vaccine, VGX-3100, at the World Vaccine
Congress.
Clinical Development
Inovio previously reported that its SynCon®
immunotherapy against HPV-caused pre-cancers and cancers
(VGX-3100), delivered with its CELLECTRA®
electroporation device, achieved best-in-class T-cell immune
responses that generated a strong killing effect against cells
targeted by this therapeutic vaccine. Inovio has completed
enrollment and treatment of patients in its double-blinded,
placebo-controlled, randomized phase II clinical trial (HPV-003)
focused on cervical dysplasia and expects to report unblinded
efficacy and immune response data in mid-2014. Inovio has initiated
preparatory activities for a potential phase III study and also
plans to initiate phase I/IIa studies of VGX-3100 against
HPV-caused cervical cancer and head and neck cancer in 2014.
In partnership with Roche, we intend to launch our prostate
cancer immunotherapy (INO-5150) phase I in the first half of 2014.
Preclinical results indicated that this therapeutic vaccine induced
potent antibody and T-cell responses in animal models, initial
evidence that our concept for a DNA vaccine comprising a broader
set of antigens delivered with electroporation may improve the
breadth and effectiveness of a prostate cancer immunotherapy. The
start of this study will trigger the first milestone payment from
Roche.
Inovio and Roche are conducting the preclinical work required to
advance INO-1800, Inovio's hepatitis B therapeutic vaccine, into a
phase I/IIa clinical trial in early 2015. Prior preclinical data
showed that INO-1800 generated robust T-cell and antibody responses
that led to the elimination of targeted liver cells in mice,
indicating the potential to treat human hepatitis B infection and
prevent progression of the infection to liver cancer.
Phase I data from Inovio's PENNVAX®-B preventive HIV
DNA vaccine (in non-infected patients) was published in the
Journal of Infectious Diseases. The results showed
best-in-class T-cell responses, with delivery with Inovio's
optimized electroporation technology achieving a seven-fold
increase (7% to 52%) in the response rate of subjects with robust
CD8+ killer T-cells compared to delivery without electroporation.
We are analyzing the immune response data from a separate study in
HIV-infected patients and will prepare a paper for submission to a
peer-reviewed scientific journal. Knowledge gained from these
studies of this single-clade HIV vaccine has been incorporated into
the Company's globally-oriented, multi-clade PENNVAX-GP, which is
now Inovio's primary preventive and therapeutic HIV DNA vaccine
candidate. Inovio expects the phase I study for this new vaccine to
begin in the second half of 2014.
Inovio and its partner VGX International announced that VGX
initiated a phase I clinical trial of Inovio's highly optimized
therapeutic hepatitis C (HCV) DNA vaccine (INO-8000/VGX-6150),
which includes Inovio's DNA-based IL-28 immune activator and is
delivered with its CELLECTRA® device. Published
preclinical results from this multi-antigen SynCon® HCV
vaccine demonstrated robust T-cell responses in the liver as well
as in the periphery. This study is being fully funded by VGX and is
being conducted at multiple study sites in Korea to test safety,
tolerability, and immunogenicity. We are planning to launch a US
clinical study in 2014, which would be dependent upon external
funding.
Inovio's SynCon® universal H1N1 influenza vaccine
generated antibody response rates with protective equivalency
relative to a conventional seasonal vaccine while uniquely
possessing the advantage of generating protective immune responses
against diverse unmatched strains. We are analyzing the data and
preparing a paper for submission to a peer-reviewed scientific
journal. The Company is seeking additional grant funding and
partnerships to further develop its potentially paradigm-changing
flu products.
Preclinical Development
Inovio continues to expand its cancer immunotherapy pipeline as
its primary product focus. The next of several products to move
from research into clinical development is INO-1400, Inovio's hTERT
DNA-based cancer immunotherapy. INO-1400 generated robust and broad
immune responses that were 18-fold higher than the previous best
results of a peer's hTERT therapeutic vaccine, broke the immune
system's tolerance to its self-antigens, induced T-cells with a
tumor-killing function, and increased the rate of survival when
delivered with Inovio's CELLECTRA® electroporation
technology. Because high levels of hTERT expression are found in
85% of human cancers, this antigen has potential as the basis of a
"universal" cancer therapeutic. Inovio plans to initiate INO-1400
clinical trials to treat breast, lung and pancreatic cancers in the
second half of 2014.
By year end 2014, we aim to have SynCon constructs designed for
a priority set of cancer-associated antigens that we believe are
the most promising targets in the battle against cancer. These
antigens will in aggregate encompass a variety of different cancer
types and will provide Inovio with a rich cancer product portfolio
to be internally developed or partnered, potentially in combination
with checkpoint inhibitors or other complementary technologies.
In 2013, Inovio also reported the publishing in peer-reviewed
scientific journals of multiple papers highlighting positive
preclinical immune response and efficacy data for DNA vaccines
against malaria and Ebola and Marburg filoviruses. Similarly, we
reported published data highlighting new technology developments
for DNA-based monoclonal antibodies and a gene therapy to stimulate
blood vessel growth, limb function recovery, and survival from limb
necrosis and amputation, which may be beneficial for the treatment
of critical limb ischemia (CLI) and other forms of peripheral
arterial disease (PAD).
Inovio has established a strong track record of publishing our
research data and development progress in peer-reviewed
publications. We look forward to 2014 as another productive
year for preclinical and clinical advancements.
About Inovio Pharmaceuticals, Inc.
Inovio is revolutionizing vaccines to prevent and treat today's
cancers and challenging infectious diseases. Its SynCon®
vaccines, in combination with its proprietary electroporation
delivery, are generating best-in-class immune responses, with
therapeutic T-cell responses exceeding other technologies in terms
of magnitude, breadth, and response rate. Human data to date have
shown a favorable safety profile. Inovio's lead vaccine, a
therapeutic against HPV-caused pre-cancers and cancers, is in phase
II. Other phase I and preclinical programs target prostate, breast,
and lung cancers as well as HIV, influenza, malaria and hepatitis.
Partners and collaborators include Roche, the University of Pennsylvania, NIH, HIV Vaccines Trial
Network, National Cancer Institute, U.S. Military HIV Research
Program, University of Southampton, US Dept. of Homeland Security,
University of Manitoba and PATH Malaria
Vaccine Initiative. More information is available at
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, 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, 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, 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.
CONSOLIDATED
BALANCE SHEETS
|
|
|
December 31,
|
|
2013
|
|
2012
|
|
(Unaudited)
|
|
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
|
33,719,796
|
|
$
|
5,646,021
|
Short-term
investments
|
18,905,608
|
|
8,034,001
|
Accounts
receivable
|
3,301,563
|
|
830,433
|
Accounts receivable
from affiliated entity
|
—
|
|
36,234
|
Prepaid expenses and
other current assets
|
637,433
|
|
471,328
|
Prepaid expenses and
other current assets from affiliated entity
|
2,057,350
|
|
887,167
|
Deferred tax
asset
|
61,839
|
|
62,728
|
Total current
assets
|
58,683,589
|
|
15,967,912
|
Restricted
cash
|
100,762
|
|
100,410
|
Fixed assets,
net
|
2,886,545
|
|
363,021
|
Investment in
affiliated entity
|
9,664,587
|
|
10,703,332
|
Intangible assets,
net
|
5,718,778
|
|
7,489,315
|
Goodwill
|
10,113,371
|
|
10,113,371
|
Common stock
warrants
|
717,500
|
|
267,200
|
Other
assets
|
402,075
|
|
134,193
|
Total
assets
|
$
|
88,287,207
|
|
$
|
45,138,754
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
Current
liabilities:
|
|
Accounts payable and
accrued expenses
|
$
|
5,444,508
|
|
$
|
3,181,574
|
Accounts payable and
accrued expenses due to affiliated entity
|
522,255
|
|
187,275
|
Accrued clinical
trial expenses
|
1,446,180
|
|
1,405,896
|
Common stock
warrants
|
19,540,583
|
|
2,859,899
|
Deferred
revenue
|
1,624,388
|
|
353,391
|
Deferred revenue from
affiliated entity
|
388,542
|
|
388,542
|
Total current
liabilities
|
28,966,456
|
|
8,376,577
|
Deferred revenue, net
of current portion
|
1,997,333
|
|
88,609
|
Deferred revenue from
affiliated entity, net of current portion
|
1,211,694
|
|
1,586,694
|
Deferred
rent
|
3,013,263
|
|
65,076
|
Deferred tax
liabilities
|
195,778
|
|
164,393
|
Total
liabilities
|
35,384,524
|
|
10,281,349
|
Commitments and
contingencies
|
|
Inovio
Pharmaceuticals, Inc. stockholders' equity:
|
|
Preferred stock—par
value $0.001; Authorized shares: 10,000,000, issued and outstanding
shares: 26 at both December 31, 2013 and December 31,
2012
|
—
|
|
—
|
Common stock—par
value $0.001; Authorized shares: 600,000,000 at December 31, 2013
and 300,000,000 at December 31, 2012, issued and outstanding:
210,304,821 at December 31, 2013 and 144,313,005 at
December 31, 2012
|
210,305
|
|
144,313
|
Additional paid-in
capital
|
348,109,661
|
|
263,897,116
|
Accumulated
deficit
|
(295,788,577)
|
|
(229,760,129)
|
Accumulated other
comprehensive (loss) income
|
(76,365)
|
|
73,362
|
Total Inovio
Pharmaceuticals, Inc. stockholders' equity
|
52,455,024
|
|
34,354,662
|
Non-controlling
interest
|
447,659
|
|
502,743
|
Total stockholders'
equity
|
52,902,683
|
|
34,857,405
|
Total liabilities
and stockholders' equity
|
$
|
88,287,207
|
|
$
|
45,138,754
|
Inovio
Pharmaceuticals, Inc.
CONSOLIDATED
STATEMENTS OF OPERATIONS
|
|
|
For the Year ended
December 31,
|
|
2013
|
|
2012
|
|
2011
|
|
(Unaudited)
|
|
|
|
|
Revenues:
|
|
|
|
|
|
Revenue under
collaborative research and development arrangements
|
$
|
9,239,547
|
|
$
|
82,536
|
|
$
|
156,397
|
Revenue under
collaborative research and development arrangements with affiliated
entity
|
425,000
|
|
577,467
|
|
411,459
|
Grants and
miscellaneous revenue
|
3,802,799
|
|
3,458,649
|
|
9,227,401
|
Total
revenues
|
13,467,346
|
|
4,118,652
|
|
9,795,257
|
Operating
expenses:
|
|
|
|
|
|
Research and
development
|
21,368,604
|
|
17,984,825
|
|
20,032,001
|
General and
administrative
|
13,643,074
|
|
10,778,359
|
|
11,988,796
|
Gain on sale of
assets
|
(2,000,000)
|
|
(1,151,000)
|
|
(587,000)
|
Total operating
expenses
|
33,011,678
|
|
27,612,184
|
|
31,433,797
|
Loss from
operations
|
(19,544,332)
|
|
(23,493,532)
|
|
(21,638,540)
|
Other income
(expense):
|
|
|
|
|
Interest and other
income, net
|
132,214
|
|
166,113
|
|
34,285
|
Change in fair value
of common stock warrants
|
(45,632,669)
|
|
1,982,620
|
|
8,690,658
|
(Loss) Gain on
investment in affiliated entity
|
(1,038,745)
|
|
1,631,819
|
|
(2,390,498)
|
Net
loss
|
(66,083,532)
|
|
(19,712,980)
|
|
(15,304,095)
|
Net loss attributable
to non-controlling interest
|
55,084
|
|
44,025
|
|
51,150
|
Net loss
attributable to Inovio Pharmaceuticals, Inc.
|
$
|
(66,028,448)
|
|
$
|
(19,668,955)
|
|
$
|
(15,252,945)
|
Loss per common
share—basic and diluted:
|
|
|
|
|
|
Net loss per share
attributable to Inovio Pharmaceuticals, Inc.
stockholders
|
$
|
(0.36)
|
|
$
|
(0.14)
|
|
$
|
(0.12)
|
Weighted average
number of common shares outstanding—basic and
diluted
|
184,351,090
|
|
136,509,247
|
|
126,239,336
|
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.