BLUE BELL, Pa.--(BUSINESS WIRE)--Inovio Pharmaceuticals, Inc. (NYSE AMEX: INO) today reported financial
results for the quarter ended June 30, 2010.
Total revenue was $1.1 million and $2.5 million for the three and six
months ended June 30, 2010, compared to $2.5 million and $2.9 million
for the three and six months ended June 30, 2009, respectively.
Total operating expenses for the three and six months ended June 30,
2010, were $6.1 million and $11.9 million as compared to $5.5 million
and $9.4 million for the three and six months ended June 30, 2009.
The net loss attributable to common stockholders for the three and six
months ended June 30, 2010, was $7.6 million, or $0.07 per share, and
$9.9 million, or $0.10 per share, as compared with a net loss
attributable to common stockholders of $10.7 million, or $0.19 per
share, and $14.1 million, or $0.28 per share, for the three and six
months ended June 30, 2009.
Revenue
Revenue from license fees and milestone revenue was $175,000 and
$248,000 for the three and six months ended June 30, 2010, as compared
to $2.3 million and $2.5 million for the three and six months ended June
30, 2009. The decrease in revenue under license fees and milestone
revenue for the three and six month periods ended June 30, 2010,
compared to the comparable periods in 2009, was mainly due to no revenue
being recognized under the Wyeth collaboration and licensing agreement
as a result of the cancellation of the agreement in July 2009.
During the three and six months ended June 30, 2010, Inovio recorded
grant and miscellaneous revenue of $960,000 and $2.3 million,
respectively, as compared to $114,000 and $216,000 for the three and six
months ended June 30, 2009. The increase in grant and miscellaneous
revenue was primarily due to revenue recognized from our contract with
the National Institute of Allergy and Infectious Diseases (“NIAID”) of
$945,000 and $1.8 million for the three and six months ended June 30,
2010, compared to $68,000 for both the three and six months ended June
30, 2009.
Operating Expenses
Research and development expenses for the three and six months ended
June 30, 2010, were $3.1 million and $5.8 million as compared to $1.2
million and $2.1 million for the three and six months ended June 30,
2009. The increase in research and development expenses for the three
and six months ended June 30, 2010, compared to the comparable periods
in 2009, was primarily due to higher costs related to work performed for
the NIAID and PATH Malaria Vaccine Initiative contracts, higher outside
services and contract labor expenses related to research and development
projects, higher outside engineering professional services related to
CELLECTRA® development, higher clinical trial costs and higher personnel
costs due to greater employee headcount on average throughout the
respective periods.
General and administrative expenses, which include business development
expenses and the amortization of intangible assets, for the three and
six months ended June 30, 2010, were $3.0 million and $6.1 million as
compared to $4.3 million and $7.3 million for the three and six months
ended June 30, 2009. The decrease in general and administrative expenses
for the three and six months ended June 30, 2010, compared to the
comparable periods in 2009, 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 $4.2 million decrease in net loss attributable to common
stockholders for the six months ended June 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 June 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 June 30, 2010, cash and cash equivalents plus short term
investments in certificates of deposit were $22.2 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. 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 2011.
Corporate Update
Corporate Development
During the quarter, Inovio and its collaborators from Drexel University,
Cheyney University, and the University of Pennsylvania received a $2.8
million grant to develop a DNA vaccine to treat hepatitis C virus (HCV).
The grant will fund pre-clinical studies to test the safety and effect
on the immune system of Inovio's novel vaccines designed to treat
persons who are chronically infected with hepatitis C virus and have not
responded to currently available therapies. People with chronic HCV
infection face an increased risk of developing hepatocellular cancer, a
difficult-to-treat cancer with a poor prognosis.
The company was awarded "Best Early Stage Biotech" Vaccine Industry
Excellence Award at the World Vaccine Congress.
The company changed its name from Inovio Biomedical to Inovio
Pharmaceuticals, Inc. to better reflect its business focus.
Preclinical Development
During the quarter, the peer-reviewed journal Molecular Therapy
published a paper highlighting that in a head-to-head comparison with a
Merck adenovirus serotype 5 (Ad5) vaccine, considered to be the most
immunogenic among viral vectors, an Inovio optimized SynConTM DNA
vaccine delivered using its proprietary electroporation technology
demonstrated numerous advantages in both magnitude and breadth of immune
responses produced in non-human primates.
Clinical Development
During the quarter, Inovio announced it had completed enrollment of all
subjects for its phase I trial of its therapeutic cervical cancer
vaccine (VGX-3100) targeting the E6 and E7 proteins of human
papillomavirus (HPV) types 16 and 18. In the first two dose cohorts, six
of 12 vaccinated subjects (50%) developed significant antigen-specific
CTL (killer T-cell) responses, with average CTL responses increasing in
a dose-related fashion. Ten of the 12 patients (83%) developed strong
antibody responses. The vaccine has been well tolerated with an
acceptable safety profile in all subjects tested. Interim immunology and
safety results from the third and final dose group are expected to be
reported in September.
Inovio immunized the first subject in its U.S. Phase I clinical trial to
evaluate its SynCon™ H5N1 (avian) influenza DNA vaccine, VGX-3400X. This
study represents the first step in demonstrating Inovio's novel
universal influenza vaccine approach, which aims to overcome the
constraints of current annual strain and subtype-specific influenza
vaccines by developing a single vaccine to potentially protect against
existing and newly emergent strains within multiple targeted subtypes,
such as H5N1 and H1N1, posing risk to humans.
About Inovio Pharmaceuticals, Inc.
Inovio is developing a new generation of vaccines, called DNA vaccines,
to treat and prevent cancers and infectious diseases. The company’s
SynCon™ vaccines are designed to provide broad cross-strain protection
against known as well as newly emergent strains of pathogens such as
influenza. When delivered with Inovio’s proprietary electroporation
delivery devices the vaccines have been shown to be safe and generate
significant immune responses. Inovio’s clinical programs include
HPV/cervical cancer (therapeutic), avian flu, and HIV vaccines (both
preventive and therapeutic). Inovio is developing universal influenza
vaccines in collaboration with scientists from the University of
Pennsylvania and National Microbiology Laboratory of the Public Health
Agency of Canada. Other partners and collaborators include Merck,
ChronTech, University of Southampton, National Cancer Institute, HIV
Vaccines Trial Network, 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
six months ended June 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
|
|
CONDENSED CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2010
|
|
|
|
December 31,
2009
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
|
$
|
14,951,754
|
|
|
|
|
$
|
30,296,215
|
|
|
Short-term investments—certificates of deposit
|
|
|
|
|
7,248,192
|
|
|
|
|
|
—
|
|
|
Short-term investments—auction rate securities
|
|
|
|
|
2,494,513
|
|
|
|
|
|
10,397,530
|
|
|
Auction rate security rights
|
|
|
|
|
5,487
|
|
|
|
|
|
3,145,156
|
|
|
Accounts receivable
|
|
|
|
|
159,701
|
|
|
|
|
|
259,207
|
|
|
Accounts receivable from affiliated entity
|
|
|
|
|
2,028,481
|
|
|
|
|
|
58,853
|
|
|
Prepaid expenses and other current assets
|
|
|
|
|
427,752
|
|
|
|
|
|
409,845
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
|
|
27,315,880
|
|
|
|
|
|
44,566,806
|
|
|
Fixed assets, net
|
|
|
|
|
383,285
|
|
|
|
|
|
343,457
|
|
|
Intangible assets, net
|
|
|
|
|
12,133,461
|
|
|
|
|
|
12,968,934
|
|
|
Goodwill
|
|
|
|
|
10,113,371
|
|
|
|
|
|
10,113,371
|
|
|
Investment in affiliated entity
|
|
|
|
|
10,047,218
|
|
|
|
|
|
12,330,802
|
|
|
Other assets
|
|
|
|
|
284,128
|
|
|
|
|
|
305,547
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
|
|
$
|
60,277,343
|
|
|
|
|
$
|
80,628,917
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses
|
|
|
|
$
|
2,479,269
|
|
|
|
|
$
|
3,445,750
|
|
|
Accounts payable and accrued expenses due to affiliated entity
|
|
|
|
|
335,380
|
|
|
|
|
|
445,091
|
|
|
Accrued clinical trial expenses
|
|
|
|
|
342,926
|
|
|
|
|
|
299,261
|
|
|
Line of credit
|
|
|
|
|
1,012,891
|
|
|
|
|
|
12,114,760
|
|
|
Common stock warrants
|
|
|
|
|
1,048,626
|
|
|
|
|
|
2,774,850
|
|
|
Deferred revenue
|
|
|
|
|
77,863
|
|
|
|
|
|
270,326
|
|
|
Deferred revenue from affiliated entity
|
|
|
|
|
375,000
|
|
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
|
|
5,671,955
|
|
|
|
|
|
19,350,038
|
|
|
Deferred revenue, net of current portion
|
|
|
|
|
86,693
|
|
|
|
|
|
82,594
|
|
|
Deferred revenue from affiliated entity, net of current portion
|
|
|
|
|
2,524,194
|
|
|
|
|
|
—
|
|
|
Deferred rent, net of current portion
|
|
|
|
|
41,879
|
|
|
|
|
|
11,338
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
|
|
8,324,721
|
|
|
|
|
|
19,443,970
|
|
|
|
|
|
|
|
|
|
|
|
|
Inovio Pharmaceuticals, Inc. stockholders’ equity:
|
|
|
|
|
|
|
|
|
|
Common stock
|
|
|
|
|
102,890
|
|
|
|
|
|
102,746
|
|
|
Additional paid-in capital
|
|
|
|
|
238,256,744
|
|
|
|
|
|
237,577,970
|
|
|
Accumulated deficit
|
|
|
|
|
(187,134,557
|
)
|
|
|
|
|
(177,224,433
|
)
|
|
Accumulated other comprehensive income
|
|
|
|
|
109,137
|
|
|
|
|
|
105,796
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Inovio Pharmaceuticals, Inc. stockholders’ equity
|
|
|
|
|
51,334,214
|
|
|
|
|
|
60,562,079
|
|
|
Non-controlling interest
|
|
|
|
|
618,408
|
|
|
|
|
|
622,868
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders’ equity
|
|
|
|
|
51,952,622
|
|
|
|
|
|
61,184,947
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity
|
|
|
|
$
|
60,277,343
|
|
|
|
|
$
|
80,628,917
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INOVIO PHARMACEUTICALS, INC
|
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
|
|
Six Months Ended
June 30,
|
|
|
|
|
|
|
|
2010
|
|
|
|
2009
|
|
|
|
2010
|
|
|
|
2009
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License fee and milestone revenue
|
|
|
|
|
$
|
174,691
|
|
|
|
$
|
2,275,374
|
|
|
|
$
|
248,301
|
|
|
|
$
|
2,488,472
|
|
|
Revenue under collaborative research and development arrangements
|
|
|
|
|
—
|
|
|
|
102,317
|
|
|
|
—
|
|
|
|
156,775
|
|
|
Grant and miscellaneous revenue
|
|
|
|
|
960,168
|
|
|
|
113,898
|
|
|
|
2,259,947
|
|
|
|
215,792
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue
|
|
|
|
|
1,134,859
|
|
|
|
2,491,589
|
|
|
|
2,508,248
|
|
|
|
2,861,039
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
|
3,083,229
|
|
|
|
1,181,194
|
|
|
|
5,813,824
|
|
|
|
2,144,927
|
|
|
General and administrative
|
|
|
|
|
3,027,593
|
|
|
|
4,300,772
|
|
|
|
6,077,751
|
|
|
|
7,266,914
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
|
|
6,110,822
|
|
|
|
5,481,966
|
|
|
|
11,891,575
|
|
|
|
9,411,841
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
|
|
(4,975,963
|
)
|
|
|
(2,990,377
|
)
|
|
|
(9,383,327
|
)
|
|
|
(6,550,802
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income/(expense), net
|
|
|
|
|
13,594
|
|
|
|
(29,931
|
)
|
|
|
48,155
|
|
|
|
3,717
|
|
|
Other income/(expense), net
|
|
|
|
|
676,179
|
|
|
|
(267,678
|
)
|
|
|
1,704,172
|
|
|
|
(205,396
|
)
|
|
Loss from investment in affiliated entity
|
|
|
|
|
(3,327,758
|
)
|
|
|
(7,368,680
|
)
|
|
|
(2,283,584
|
)
|
|
|
(7,368,680
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
(7,613,948
|
)
|
|
|
(10,656,666
|
)
|
|
|
(9,914,584
|
)
|
|
|
(14,121,161
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (gain)/loss attributable to non-controlling interest
|
|
|
|
|
(2,490
|
)
|
|
|
3,730
|
|
|
|
4,460
|
|
|
|
3,730
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to Inovio Pharmaceuticals, Inc.
|
|
|
|
|
$
|
(7,616,438
|
)
|
|
|
$
|
(10,652,936
|
)
|
|
|
$
|
(9,910,124
|
)
|
|
|
$
|
(14,117,431
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per common share — basic and diluted:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share attributable to Inovio Pharmaceuticals, Inc.
stockholders
|
|
|
|
|
$
|
(0.07
|
)
|
|
|
$
|
(0.19
|
)
|
|
|
$
|
(0.10
|
)
|
|
|
$
|
(0.28
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares
outstanding
— basic and diluted
|
|
|
|
|
102,811,417
|
|
|
|
57,303,620
|
|
|
|
102,784,297
|
|
|
|
50,743,262
|
|