BLUE BELL, Pa.--(BUSINESS WIRE)--Inovio Pharmaceuticals, Inc. (NYSE AMEX: INO) today reported financial
results for the quarter ended March 31, 2010.
Total revenue for the quarter ended March 31, 2010, was $1.4 million,
compared with $369,000 for the same period in 2009. Total operating
expenses for the quarter ended March 31, 2010, were $5.8 million,
compared with $3.9 million for the same period in 2009. The net loss
attributable to common stockholders for the quarter ended March 31,
2010, was $2.3 million, or $(0.02) per share, compared with a net loss
attributable to common stockholders of $3.5 million, or $(0.08) per
share for the same period in 2009.
Revenue
The increase in revenue was due to an increase in grant and
miscellaneous revenue for the quarter ended March 31, 2010, to $1.3
million, compared to $102,000 for the same period in 2009. The increase
was primarily due to revenues recognized from our contract with the
National Institute of Allergy and Infectious Diseases (“NIAID”) and the
PATH Malaria Vaccine Initiative (“MVI”) of $835,000 and $239,000,
respectively, and from the Department of Defense (“U.S. Army”) grant of
$200,000. The NIAID contract provides for a total potential value of
$23.5 million to fund research and development for HIV DNA-based
vaccines delivered via our proprietary electroporation system ($21.3
million over five years starting September 2008, with two one-year
options valued at $1.2 million and $1.1 million). PATH is an
international nonprofit organization funded by private donors. We have a
research program and agreement with the PATH MVI to evaluate in a
preclinical feasibility study our SynConTM DNA vaccine
development platform to target antigens from malaria-causing Plasmodium
species. The agreement with MVI was for $685,000 and ran through
February 2010. The U.S. Army grant of $933,000, running through May
2010, is funding research and development of DNA-based vaccines,
delivered via our proprietary electroporation system, against
bio-warfare and bioterror attacks.
The revenue increase was somewhat offset by a decline in license fees
and milestone revenue for the quarter to $74,000, compared to $213,000
for the same period in 2009. This decrease was mainly due to no revenues
recognized under the Wyeth collaboration and licensing agreement as a
result of the cancellation of the agreement in July 2009.
Operating Expenses
Research and development expenses for the quarter ended March 31, 2010
were $2.7 million, compared to $964,000 for the same period in 2009. The
increase was primarily due to higher costs related to work performed for
the NIAID and MVI contracts, other outside services and contract labor
expenses related to research and development projects, outside
engineering professional services related to CELLECTRA® development,
clinical trials and a greater employee headcount.
General and administrative expenses, including business development
expenses, were $3.1 million for the quarter ended March 31, 2010,
compared to $3.0 million for the same period in 2009. The increase was
primarily due to higher amortization expense as a result of the
intangible assets acquired from VGX, greater employee headcount and a
higher consultant stock option expense resulting from stock options
acquired from VGX.
Net Loss Attributable to Common Stockholders
The $1.2 million decrease in net loss attributable to common
stockholders for the quarter ended March 31, 2010, as compared to the
same period in 2009, resulted primarily from the increase in grant and
miscellaneous revenue recognized, an increase in other income from the
revaluation of registered common stock warrants and the gain from the
change in fair market value of our investment in VGX International as of
March 31, 2010. This decrease was somewhat offset by an increase in
general and administrative as well as research and development expenses.
Capital Resources
We ended the first quarter of 2010 with cash and cash equivalents plus
short term investments in certificates of deposit of $25.7 million, as
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, we believe
that our cash, cash equivalents and short-term investments are
sufficient to meet our planned working capital requirements through the
second half of 2011.
Corporate Update
Corporate Development
In January 2010, Mark L. Bagarazzi, M.D., was appointed chief medical
officer to lead clinical development and regulatory activities for
Inovio's next-generation vaccines for the treatment and prevention of
influenza, HIV, other infectious diseases and cancers. Dr. Bagarazzi
joined Inovio from Merck & Co., where he was director of worldwide
regulatory affairs for vaccines and biologics.
Also in January 2010, Inovio expanded its existing license agreement
with the University of Pennsylvania, adding exclusive worldwide licenses
for technology and intellectual property for novel DNA vaccines against
pandemic influenza, Chikungunya, and foot-and-mouth disease. The
amendment also encompasses new chemokine and cytokine molecular adjuvant
technologies. The technology was developed in the University of
Pennsylvania laboratory of Professor David B. Weiner, a pioneer in the
field of DNA vaccines, and chairman of Inovio's scientific advisory
board.
In March 2010, Inovio entered into a Collaboration and License Agreement
with VGX International. Under the Agreement, Inovio granted VGX
International an exclusive license to Inovio’s SynConTM
universal influenza vaccine delivered with electroporation to be
developed in certain countries in Asia. As consideration for the license
granted to VGX International, the Company will receive a payment of $3
million as a research and development initiation fee which is reflected
in the Company’s accounts receivable from affiliated entity at March 31,
2010.
Clinical Development
In February 2010, we reported immune responses from the second,
intermediate dose group of our therapeutic cervical cancer vaccine
(VGX-3100) phase I clinical study. The antigen-specific antibody and
T-cell immune responses from this dose group significantly exceeded
levels reported in the first dose group, suggesting a dose response.
Subsequent to quarter end, we announced completion of enrollment of this
study. We expect to report the third and final dose group in late Q3 or
Q4, 2010.
In March 2010, our affiliate, VGX International, obtained Korean
approval to initiate a phase I clinical study of Inovio’s H5N1 influenza
vaccine candidate in Korea. Inovio expects to obtain FDA approval to
initiate a US phase I clinical trial in Q2 2010. These studies will
focus on safety and immunogenicity (levels of vaccine-induced immune
responses). In previously reported animal studies, this vaccine provided
100% protection of non-human primates against the H5N1 avian influenza
virus, including multiple unmatched avian influenza strains.
In April 2010, 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. Persons with chronic HCV
infection face an increased risk of developing hepatocellular cancer, a
difficult-to-treat cancer with a poor prognosis.
About Inovio Pharmaceuticals, Inc.
Inovio Pharmaceuticals is focused on the development of a new generation
of vaccines, called DNA vaccines, to prevent and treat cancers and
infectious diseases. The company’s SynCon™ “universal” vaccines are
designed to provide broad cross-strain protection against known as well
as newly emergent strains of pathogens such as influenza. Inovio’s
proprietary electroporation delivery technology has been shown by
initial human data to be safe and significantly increase gene expression
and immune responses. Inovio’s clinical programs include HPV/cervical
cancer (therapeutic), avian flu, and HIV vaccines. Inovio is developing
its universal influenza vaccines in collaboration with scientists from
the University of Pennsylvania, National Microbiology Laboratory of the
Public Health Agency of Canada, and NIH’s Vaccine Research Center. Other
partners and collaborators include Merck, ChronTech, University of
Southampton, National Cancer Institute, and HIV Vaccines Trial Network.
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
three months ended March 31, 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.
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INOVIO PHARMACEUTICALS, INC.
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CONDENSED CONSOLIDATED BALANCE SHEETS
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March 31,
2010
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December 31,
2009
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ASSETS
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Current assets:
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Cash and cash equivalents
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$
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17,710,983
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$
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30,296,215
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Short-term investments – certificates of deposit
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8,000,000
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—
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Short-term investments – auction rate securities
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10,836,476
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10,397,530
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Auction rate security rights
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2,706,210
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3,145,156
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Accounts receivable
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344,061
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259,207
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Accounts receivable from affiliated entity
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3,061,207
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58,853
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Prepaid expenses and other current assets
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463,562
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409,845
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Total current assets
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43,122,499
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44,566,806
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Fixed assets, net
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339,984
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343,457
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Intangible assets, net
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12,487,537
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12,968,934
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Goodwill
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10,113,371
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10,113,371
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Investment in affiliated entity
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13,374,976
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12,330,802
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Other assets
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283,478
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305,547
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Total assets
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$
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79,721,845
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$
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80,628,917
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LIABILITIES AND STOCKHOLDERS’ EQUITY
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Current liabilities:
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Accounts payable and accrued expenses
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$
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2,915,220
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$
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3,445,750
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Accounts payable and accrued expenses due to affiliated entity
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128,720
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445,091
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Accrued clinical trial expenses
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299,313
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299,261
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Line of credit
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12,097,634
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12,114,760
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Common stock warrants
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1,718,492
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2,774,850
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Deferred revenue
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151,532
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270,326
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Deferred revenue from affiliated entity
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375,000
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—
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Deferred rent
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1,917
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—
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Total current liabilities
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17,687,828
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19,350,038
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Deferred revenue, net of current portion
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72,580
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82,594
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Deferred revenue from affiliated entity, net of current portion
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2,617,944
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—
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Deferred rent, net of current portion
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23,844
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11,338
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Total liabilities
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20,402,196
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19,443,970
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Inovio Pharmaceuticals, Inc. stockholders’ equity:
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Common stock
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102,766
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102,746
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Additional paid-in capital
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238,008,428
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237,577,970
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Accumulated deficit
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(179,518,119
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(177,224,433
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Accumulated other comprehensive income
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110,656
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105,796
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Total Inovio Pharmaceuticals, Inc. stockholders’ equity
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58,703,731
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60,562,079
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Non-controlling interest
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615,918
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622,868
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Total stockholders’ equity
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59,319,649
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61,184,947
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Total liabilities and stockholders’ equity
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$
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79,721,845
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$
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80,628,917
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INOVIO PHARMACEUTICALS, INC.
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
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(Unaudited)
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Three Months Ended
March 31,
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2010
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2009
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Revenue:
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License fee and milestone revenue
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$
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73,610
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$
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213,098
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Revenue under collaborative research and development arrangements
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—
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54,458
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Grant and miscellaneous revenue
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1,299,779
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101,894
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Total revenue
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1,373,389
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369,450
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Operating expenses:
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Research and development
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2,730,595
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963,733
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General and administrative
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3,050,158
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2,966,142
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Total operating expenses
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5,780,753
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3,929,875
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Loss from operations
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(4,407,364
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(3,560,425
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Interest income, net
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34,561
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33,648
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Other income, net
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1,027,993
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62,282
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Gain from investment in affiliated entity
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1,044,174
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—
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Net loss
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(2,300,636
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(3,464,495
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Net loss attributable to non-controlling interest
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6,950
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—
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Net loss attributable to Inovio Pharmaceuticals, Inc.
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$
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(2,293,686
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$
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(3,464,495
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Loss per common share — basic and diluted:
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Net loss per share attributable to Inovio Pharmaceuticals, Inc.
stockholders
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$
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(0.02
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$
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(0.08
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Weighted average number of common shares outstanding — basic and
diluted
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102,757,083
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44,035,480
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Contacts
Investors:
Inovio Pharmaceuticals
Bernie Hertel, 858-410-3101
or
Media:
Richardson
& Associates
Jeff Richardson, 805-491-8313