BLUE BELL, Pa.--(BUSINESS WIRE)--Inovio Pharmaceuticals, Inc. (NYSE AMEX:INO) today reported financial
results for the quarter ended September 30, 2010.
Total revenue was $1.3 million and $3.8 million for the three and nine
months ended September 30, 2010, compared to $3.6 million and $6.5
million for the three and nine months ended September 30, 2009,
respectively.
Total operating expenses for the three and nine months ended September
30, 2010, were $5.8 million and $17.7 million as compared to $7.2
million and $16.7 million for the three and nine months ended September
30, 2009.
The net loss attributable to common stockholders for the three and nine
months ended September 30, 2010, was $1.4 million, or $0.01 per share,
and $11.3 million, or $0.11 per share, as compared with a net loss
attributable to common stockholders of $2.9 million, or $0.03 per share,
and $17.1 million, or $0.26 per share, for the three and nine months
ended September 30, 2009.
Revenue
Revenue from license fees and milestone revenue was $133,000 and
$381,000 for the three and nine months ended September 30, 2010, as
compared to $2.1 million and $4.6 million for the three and nine months
ended September 30, 2009. The decreases in the respective periods were
mainly due to no revenue being recognized under the terminated Wyeth
collaboration and licensing agreement as a result of the cancellation of
the agreement in July 2009.
During the three and nine months ended September 30, 2010, Inovio
recorded grant and miscellaneous revenue of $1.1 million and $3.4
million, respectively, as compared to $1.5 million and $1.8 million for
the three and nine months ended September 30, 2009. The decrease for the
comparable three month periods was primarily due to lower revenue
recognized from our contract with the National Institute of Allergy and
Infectious Diseases (NIAID). The increase for the comparable nine month
periods was primarily due to more revenue recognized from our contract
with the NIAID during the first and second quarters of 2010.
Operating Expenses
Research and development expenses for the three and nine months ended
September 30, 2010, were $3.0 million and $8.8 million as compared to
$3.4 million and $5.6 million for the three and nine months ended
September 30, 2009. The decrease in research and development expenses
for the comparable three month periods was primarily due to lower costs
related to work performed for the NIAID, lower costs related to our
subsidiary, VGX Animal Health, as well as lower severance expenses. The
increase in research and development expenses for the comparable nine
month periods was primarily due to higher costs related to work
performed for the NIAID and PATH Malaria Vaccine Initiative contracts,
outside services and contract labor related to research and development
projects, outside engineering professional services related to
CELLECTRA® development, clinical trials, and greater employee headcount
on average throughout the respective periods.
General and administrative expenses, which include business development
expenses and amortization of intangible assets, for the three and nine
months ended September 30, 2010, were $2.9 million and $9.0 million as
compared to $3.8 million and $11.1 million for the three and nine months
ended September 30, 2009. The decrease for the comparable three and nine
month periods was primarily due to a decrease in legal and other
expenses associated with the merger and other corporate matters. The
decrease was partially offset by higher amortization expense as a result
of the intangible assets that were acquired from VGX Pharmaceuticals and
higher personnel costs due to greater employee headcount on average
throughout the respective periods.
Net Loss Attributable to Common Stockholders
The $5.7 million decrease in net loss attributable to common
stockholders for the nine months ended September 30, 2010, compared with
the same period in 2009, resulted primarily from a decrease in the loss
related to the change in fair market value of our investment in VGX
International as of September 30, 2010, increase in other income from
the revaluation of registered common stock warrants, increase in grant
and miscellaneous revenue and a decrease in general and administrative
expenses.
Capital Resources
As of September 30, 2010, cash and cash equivalents plus short term
investments in certificates of deposit were $23.5 million, compared to
$30.3 million in cash and cash equivalents as of December 31, 2009. This
change primarily resulted from the use of cash for research and
development as well as general and administrative expenses, offset by
$3.0 million received from VGX International in connection with the
March 2010 Collaboration and License Agreement.
Inovio also issued 506,800 shares at an average price of $1.12 per share
with net proceeds to the Company of $549,000. These shares were sold
under an At-the-Market Equity Offering, the details of which were filed
with the SEC under an 8-K on August 27, 2010. This Offering allows the
company to sell shares from time-to-time at its discretion through an
agent into the market.
Based on management’s projections and analysis, the company believes
that its cash and cash equivalents are sufficient to meet our planned
working capital requirements through the end of first quarter 2012.
Corporate Update
Corporate Development
During the quarter, the PATH Malaria Vaccine Initiative (MVI) agreed to
provide follow-on funding to continue evaluation and development of
Inovio's malaria DNA vaccine candidate in non-human primates.
Inovio and the University of Pennsylvania received a grant of $3.1
million from the National Institutes of Health (NIH) Director's Office
to further fund Inovio's universal SynCon(TM) flu vaccine development.
The company was acknowledged by the Philadelphia Business Journal
as part of the Journal's inaugural Life Sciences Awards by their naming
of Dr. Joseph Kim, President & CEO, as Life Sciences CEO of the Year and
by also recognizing the company with awards as Best Local Research-Based
Company and Best Incubator Graduate (VGX Pharmaceuticals, which merged
with Inovio Biomedical in June 2009 began as a start-up vaccine
development company in Philadelphia's University City Science Center
Incubator.)
Preclinical Development
Subsequent to the quarter end, a peer-reviewed research article, "Prototype
development and preclinical immunogenicity analysis of a novel minimally
invasive electroporation device," describing the development of
Inovio’s new intradermal, minimally-invasive DNA vaccine delivery device
was published in the prestigious journal Gene Therapy. This very
low voltage device does not penetrate the skin and further enhances the
previously established tolerability of Inovio's electroporation devices.
Clinical Development
During the quarter, Inovio announced it achieved best-in-class immune
responses in its Phase I dose escalation study of VGX-3100, its DNA
vaccine to treat pre-cancerous cervical dysplasias and cervical cancers
caused by human papillomavirus (HPV) types 16 and 18. This vaccine
targets HPV E6 and E7 proteins and is delivered via in vivo
electroporation. All dose groups developed significant antibody and
T-cell immune responses; notably, in the third and final dose group,
five of six (83%) patients developed unprecedented T-cell responses not
achieved by any other non-replicating vaccine platform in humans.
VGX-3100 delivered using Inovio's proprietary CELLECTRA® intramuscular
electroporation delivery device was generally safe and well tolerated at
all dose levels. There were no vaccine-related serious adverse events;
reported adverse events and injection site reactions were mild to
moderate and required no treatment. Inovio is planning to start a Phase
II clinical study in the first quarter of 2011.
The Phase I clinical study assessing Inovio's PENNVAXTM-B DNA
vaccine delivered using its proprietary electroporation technology in a
preventive setting fully completed enrollment of 48 healthy volunteers.
The multi-center study is being conducted by Inovio's clinical
collaborator, the HIV Vaccine Trials Network (HVTN), at several clinical
sites under a protocol designated HVTN-080. Inovio expects to report
interim data from this study in Q4 2010.
A new Phase I study, called RV262, began to evaluate a combination DNA
prime/MVA vector boost regimen that was developed to protect against
diverse subtypes of HIV-1 prevalent in North America, Europe, Africa,
and South America. The National Institute of Allergy and Infectious
Diseases (NIAID), part of the U.S. National Institutes of Health (NIH),
is sponsoring the study, which will enroll 92 total participants and is
designed to assess safety and immune responses. The study is being
conducted by the U.S. Military HIV Research Program (MHRP) through its
clinical research network in the US, East Africa and Thailand. This
clinical trial was designed to test a unique prime-boost preventive HIV
vaccination strategy aimed at global coverage. The prime is Inovio’s
plasmid DNA vaccine, PENNVAXTM-G.
About Inovio Pharmaceuticals, Inc.
Inovio is developing a new generation of vaccines, called DNA vaccines,
to treat and prevent cancers and infectious diseases. These SynCon™
vaccines are designed to provide broad cross-strain protection against
known as well as newly emergent strains of pathogens such as influenza.
These vaccines, in combination with Inovio’s proprietary electroporation
delivery devices, have been shown to be safe and generate significant
immune responses. Inovio’s clinical programs include HPV/cervical
dysplasia and cancer (therapeutic), avian flu (preventive), and HIV
vaccines (both preventive and therapeutic). Inovio is developing
universal influenza and other vaccines in collaboration with scientists
from the University of Pennsylvania. Other partners and collaborators
include Merck, National Cancer Institute, U.S. Military HIV Research
Program, HIV Vaccines Trial Network, National Microbiology Laboratory of
the Public Health Agency of Canada, 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 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 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, our ability to successfully
integrate Inovio and VGX Pharmaceuticals, 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, 2009, our Form 10-Q for the
nine months ended September 30, 2010, 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
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2010
|
|
December 31,
2009
|
|
|
|
(Unaudited)
|
|
|
|
ASSETS
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
19,391,860
|
|
|
$
|
30,296,215
|
|
|
Short-term investments—certificates of deposit
|
|
|
4,109,934
|
|
|
|
—
|
|
|
Short-term investments—auction rate securities
|
|
|
—
|
|
|
|
10,397,530
|
|
|
Auction rate security rights
|
|
|
—
|
|
|
|
3,145,156
|
|
|
Accounts receivable
|
|
|
178,655
|
|
|
|
259,207
|
|
|
Accounts receivable from affiliated entity
|
|
|
37,048
|
|
|
|
58,853
|
|
|
Prepaid expenses and other current assets
|
|
|
313,319
|
|
|
|
309,865
|
|
|
Prepaid expenses and other current assets from affiliated entity
|
|
|
241,390
|
|
|
|
99,980
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
24,272,206
|
|
|
|
44,566,806
|
|
|
Fixed assets, net
|
|
|
340,820
|
|
|
|
343,457
|
|
|
Intangible assets, net
|
|
|
11,654,897
|
|
|
|
12,968,934
|
|
|
Goodwill
|
|
|
10,113,371
|
|
|
|
10,113,371
|
|
|
Investment in affiliated entity
|
|
|
12,651,529
|
|
|
|
12,330,802
|
|
|
Other assets
|
|
|
284,128
|
|
|
|
305,547
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
59,316,951
|
|
|
$
|
80,628,917
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
Accounts payable and accrued expenses
|
|
$
|
3,016,557
|
|
|
$
|
3,445,750
|
|
|
Accounts payable and accrued expenses due to affiliated entity
|
|
|
477,769
|
|
|
|
445,091
|
|
|
Accrued clinical trial expenses
|
|
|
360,163
|
|
|
|
299,261
|
|
|
Line of credit
|
|
|
—
|
|
|
|
12,114,760
|
|
|
Common stock warrants
|
|
|
510,055
|
|
|
|
2,774,850
|
|
|
Deferred revenue
|
|
|
485,288
|
|
|
|
270,326
|
|
|
Deferred revenue from affiliated entity
|
|
|
375,000
|
|
|
|
—
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
5,224,832
|
|
|
|
19,350,038
|
|
|
Deferred revenue, net of current portion
|
|
|
79,736
|
|
|
|
82,594
|
|
|
Deferred revenue from affiliated entity, net of current portion
|
|
|
2,430,444
|
|
|
|
—
|
|
|
Deferred rent, net of current portion
|
|
|
49,670
|
|
|
|
11,338
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
7,784,682
|
|
|
|
19,443,970
|
|
|
|
|
|
|
|
|
Stockholders’ equity:
|
|
|
|
|
|
Inovio Pharmaceuticals, Inc. stockholders’ equity:
|
|
|
|
|
|
Common stock
|
|
|
103,467
|
|
|
|
102,746
|
|
|
Additional paid-in capital
|
|
|
239,243,028
|
|
|
|
237,577,970
|
|
|
Accumulated deficit
|
|
|
(188,544,705
|
)
|
|
|
(177,224,433
|
)
|
|
Accumulated other comprehensive income
|
|
|
116,656
|
|
|
|
105,796
|
|
|
|
|
|
|
|
|
Total Inovio Pharmaceuticals, Inc. stockholders’ equity
|
|
|
50,918,446
|
|
|
|
60,562,079
|
|
|
Non-controlling interest
|
|
|
613,823
|
|
|
|
622,868
|
|
|
|
|
|
|
|
|
Total stockholders’ equity
|
|
|
51,532,269
|
|
|
|
61,184,947
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity
|
|
$
|
59,316,951
|
|
|
$
|
80,628,917
|
|
|
|
|
|
|
|
|
|
|
|
|
INOVIO PHARMACEUTICALS, INC
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
|
|
2010
|
|
|
|
2009
|
|
|
|
2010
|
|
|
|
2009
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
License fee and milestone revenue
|
|
$
|
133,080
|
|
|
$
|
2,143,239
|
|
|
$
|
381,381
|
|
|
$
|
4,631,711
|
|
|
Revenue under collaborative research and development arrangements
|
|
|
—
|
|
|
|
32,885
|
|
|
|
—
|
|
|
|
120,227
|
|
|
Grant and miscellaneous revenue
|
|
|
1,143,463
|
|
|
|
1,470,337
|
|
|
|
3,403,410
|
|
|
|
1,755,562
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
1,276,543
|
|
|
|
3,646,461
|
|
|
|
3,784,791
|
|
|
|
6,507,500
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
2,951,067
|
|
|
|
3,412,130
|
|
|
|
8,764,891
|
|
|
|
5,557,057
|
|
|
General and administrative
|
|
|
2,881,994
|
|
|
|
3,830,703
|
|
|
|
8,959,745
|
|
|
|
11,097,617
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
5,833,061
|
|
|
|
7,242,833
|
|
|
|
17,724,636
|
|
|
|
16,654,674
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(4,556,518
|
)
|
|
|
(3,596,372
|
)
|
|
|
(13,939,845
|
)
|
|
|
(10,147,174
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
Interest income/(expense), net
|
|
|
14,714
|
|
|
|
(26,620
|
)
|
|
|
62,869
|
|
|
|
(22,903
|
)
|
|
Other income/(expense), net
|
|
|
522,760
|
|
|
|
(2,903,174
|
)
|
|
|
2,226,932
|
|
|
|
(3,108,570
|
)
|
|
Gain/(loss) from investment in affiliated entity
|
|
|
2,604,311
|
|
|
|
3,564,283
|
|
|
|
320,727
|
|
|
|
(3,804,397
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(1,414,733
|
)
|
|
|
(2,961,883
|
)
|
|
|
(11,329,317
|
)
|
|
|
(17,083,044
|
)
|
|
Net loss attributable to non-controlling interest
|
|
|
4,585
|
|
|
|
13,697
|
|
|
|
9,045
|
|
|
|
17,427
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to Inovio Pharmaceuticals, Inc.
|
|
$
|
(1,410,148
|
)
|
|
$
|
(2,948,186
|
)
|
|
$
|
(11,320,272
|
)
|
|
$
|
(17,065,617
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Loss per common share — basic and diluted:
|
|
|
|
|
|
|
|
|
|
Net loss per share attributable to Inovio Pharmaceuticals, Inc.
stockholders
|
|
$
|
(0.01
|
)
|
|
$
|
(0.03
|
)
|
|
$
|
(0.11
|
)
|
|
$
|
(0.26
|
)
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares
outstanding
— basic and diluted
|
|
|
102,928,096
|
|
|
|
93,909,945
|
|
|
|
102,832,795
|
|
|
|
65,415,951
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|