09.05.2008 22:24:00
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Therapeutic DNA Vaccine Company Inovio Biomedical Reports First Quarter 2008 Financial Results
Inovio Biomedical Corporation (AMEX: INO) ("Inovio”)
today reported financial results for the quarter ended March 31, 2008.
Total revenue for the quarter ended March 31, 2008, was $653,000,
compared with $504,000 for the same period in 2007. For the first
quarter, revenue consisted of license fees and milestone payments, and
amounts earned from collaborative research and development arrangements.
Total operating expenses for the quarter ended March 31, 2008, was $4.0
million, compared with $4.8 million for the same period in 2007.
The net loss attributable to common stockholders for the quarter ended
March 31, 2008, was $3.0 million, or $0.07 per share, compared with a
net loss attributable to common stockholders of $3.8 million, or $0.10
per share for the same period in 2007.
Revenue
Revenue from license fees and milestone payments for the quarter ended
March 31, 2008, was $193,000, compared with $234,000 for the same period
in 2007. The decrease in license fees and milestone payments for the
three months ended March 31, 2008, compared with the same period in
2007, was primarily due to less revenue recognized from the Merck
licensing agreement as this agreement was fully amortized during 2007,
offset by higher revenue recognized from license agreements for our
GeneSwitch®
technology.
Revenue recorded under collaborative research and development
arrangements for the quarter ended March 31, 2008, was $460,000,
compared with $248,000 for the same period in 2007. The increase in
revenue under collaborative research and development arrangements during
the three months ended March 31, 2008, compared with the same period in
2007, was primarily due to an increase in Wyeth billings based on our
collaborative agreement related to the commercialization of the Elgen®
device, offset by slightly lower Merck collaborative research billings.
Billings from research and development work performed pursuant to the
Wyeth and Merck agreements are recorded as revenue when the related
research expenditures are incurred.
There was no grant and miscellaneous revenue for the three months ended
March 31, 2008, compared with $21,000 for the same period in 2007. The
decrease in grant and miscellaneous revenue was mainly due to no revenue
being recognized from the U.S. Army grant due to completion of the
defined project.
Operating Expenses
Research and development expenses for the quarter ended March 31, 2008,
were $1.6 million compared with $2.5 million for the same period in
2007. The decrease in research and development expenses for the three
months ended March 31, 2008, compared with the same period in 2007, was
primarily due to a decrease in clinical trial expenses associated with
patient enrollment, clinical site costs, data collection and monitoring
costs, and costs related to the use of outside Clinical Research
Organizations ("CROs”)
and Clinical Research Associates ("CRAs”).
These decreases were offset by higher costs associated with the
expansion of our in-house engineering and research expertise.
General and administrative expenses, which include business development
expenses and amortization of intangible assets, for the quarter ended
March 31, 2008, were $2.4 million compared with $2.3 million for the
same period in 2007. The increase in general and administrative expenses
for the three months ended March 31, 2008, compared to the same period
in 2007, was primarily due to an increase in outside consulting services
related to the effort to partner our SECTA therapy program and other
corporate advisory services, and an increase in legal fees associated
with intellectual property, business development efforts and other
corporate legal matters, offset by lower employee share-based
compensation expense.
Net Loss Attributable to Common Stockholders
The decrease in net loss attributable to common stockholders for the
three months ended March 31, 2008, compared with the same period in
2007, resulted primarily from the increase in collaborative research and
development revenue and the decrease in research and development
operating expenses, as described above.
Capital Resources
We ended the first quarter of 2008 with cash and short-term investments
of $11.3 million and working capital of $9.5 million, compared with
$27.3 million in cash and short-term investments and $25.6 million in
working capital as of December 31, 2007. The decrease in working capital
during the three months ended March 31, 2008, was primarily due to the
reclassification of $12.7 million of auction rate security ("ARS”)
investments from short-term to long-term assets. The remaining decrease
in working capital was primarily due to expenditures related to our
research and development and clinical trial activities, as well as
various general and administrative expenses related to consultants,
legal, accounting and audit, corporate development, and investor
relations activities.
With respect to the reclassification of ARS investments, we originally
purchased six high-grade ARSs, issued primarily by municipalities, for
approximately $13.6 million. In March 2008, our investment advisor
informed us that decreased market liquidity for this type of security
caused the valuation of these investments to fall below par. At March
31, 2008, we recorded on our consolidated balance sheet an unrealized
loss of $829,000 on these investments and reclassified $12.7 million as
a long-term asset.
These securities retain the AAA/AA ratings they had when we purchased
them, and have yielded uninterrupted interest payments that we receive
on a monthly basis directly from the issuers. The lack of liquidity may
require us to hold the ARSs until they are redeemed by the issuer or to
maturity, but we believe the decline in their liquidity and fair value
is temporary. We expect that liquidity of these investments is not
required to fund our operations during the next twelve months.
Corporate Update
The operational highlights for the first quarter included the results
reported by our partners from ongoing DNA vaccine clinical studies,
adding further positive interim results to data reported in 2007. A
summary of these results follows, covering clinical studies using
Inovio's electroporation delivery technology.
First, interim data from a phase I clinical trial at the Moffitt Cancer
Center demonstrated that a DNA-based immunotherapy (plasmid IL-12)
against metastatic melanoma, delivered using Inovio's electroporation
delivery technology, was safe and well-tolerated. Despite starting from
nominal dose levels and without reaching dose-limiting toxicity, this
therapy achieved evidence of durable local and systemic tumor
regression. Of 19 patients with both treated and untreated distal
lesions, two (10%) showed complete regression of all lesions (including
distal untreated lesions), suggesting a systemic effect of the therapy.
Additional patients (42%) showed a systemic response resulting in stable
disease or objective regression of untreated lesions.
Second, Tripep AB reported preliminary results from the first patient to
complete treatment with Tripep's therapeutic hepatitis C virus (HCV)
vaccine, ChronVac-C(R), which was delivered using Inovio's
electroporation-based DNA delivery system. In this phase I/II clinical
study, the treatment was shown to be tolerable and safe. Samples taken
before, during and after treatment showed that before vaccination the
patient did not have a detectable cell-mediated immune response against
HCV but such an immune response became detectable after treatment was
completed. It is known that patients who spontaneously clear their
infection have also developed this type of immune response. Five
patients had been treated as of the reporting date and no unexpected
side effects had been observed.
Third, the University of Southampton presented interim data from its
phase I/II clinical study of an experimental DNA-based prostate cancer
vaccine, indicating that the combination of this DNA vaccine and
electroporation DNA delivery was safe and well-tolerated. The study had
completed recruitment of 30 patients and vaccination was ongoing at the
third (highest) dose level. Monitoring of antibody responses had been
completed for the 20 patients at the first and second dose levels to
week 16. Monitoring of CD4 cellular immunity had been completed for the
10 patients at the lowest dose. Patients treated using electroporation
displayed higher levels of antibody and cellular immune responses:
13 of 20 patients developed increases in anti-DOM (the immunostimulant
sequence from tetanus) antibody by week 16 after three vaccinations.
Of these increased responses, 4 of 10 were in the arm without
electroporation; 9 of 10 were in the electroporation arm. Antibody
responses were generally higher in patients treated using
electroporation compared to those treated with the DNA vaccine alone
(without electroporation).
In 9 of 10 patients in the low dose cohort, increases in CD4 responses
(cellular immunity) were observed. The use of electroporation-based
DNA delivery appears to increase the level of anti-DOM CD4 responses.
We are pleased with the positive additional results reported from
multiple DNA vaccine clinical studies and look forward to additional
data being reported through 2008.
About Inovio Biomedical Corporation
Inovio Biomedical (AMEX: INO) is focused on developing multiple
DNA-based immunotherapies and DNA vaccines. Inovio is a leader
in developing human applications of electroporation using brief,
controlled electrical pulses to increase cellular uptake of a useful
biopharmaceutical. Human data has shown that Inovio’s
electroporation-based
DNA delivery technology can significantly increase gene expression
and immune responses from DNA vaccines. Immunotherapy partners include
Merck, Wyeth, Vical, University of Southampton, Moffitt Cancer Center,
the U.S. Army, National Cancer Institute, and International Aids Vaccine
Initiative. Inovio’s technology is protected
by an extensive patent portfolio covering in vivo
electroporation. More information is available at www.inovio.com.
This press release contains certain forward-looking statements
relating to our plans to develop our electroporation drug and gene
delivery technology. Actual events or results may differ from our
expectations as a result of a number of factors, including the
uncertainties inherent in 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 and that
results from one study may necessarily not be reflected or supported by
the results of other similar studies), the availability of funding to
support continuing research and studies in an effort to prove safety and
efficacy of Inovio’s technology as a delivery
mechanism, the availability or potential availability of alternative
therapies or treatments for the conditions targeted by Inovio or its
collaborators, including alternatives that may be more efficacious or
cost-effective than any therapy or treatment that Inovio and its
collaborators hope to develop, evaluation of potential opportunities,
issues involving patents and whether they or licenses to them will
provide Inovio 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 Inovio can finance or devote
other significant resources that may be necessary to prosecute, protect
or defend them, the level of corporate expenditures, assessments of our
technology by potential corporate or other partners or collaborators,
capital market conditions, and other factors set forth in our Annual
Report on Form 10-K for the year ended December 31, 2007, our 10-Q for
the three months ended March 31, 2008 and other regulatory filings from
time to time. There can be no assurance that any product in our product
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 proved accurate. INOVIO BIOMEDICAL CORPORATION CONDENSED CONSOLIDATED BALANCE SHEETS
March 31,2008
December 31,2007 (Unaudited) ASSETS Current assets:
Cash and cash equivalents
$
8,282,208
$
10,250,929
Short-term investments
2,991,300
16,999,600
Accounts receivable
476,844
1,139,966
Prepaid expenses and other current assets
618,738
613,656
Total current assets
12,369,090
29,004,151
Investments
12,720,720
—
Fixed assets, net
378,113
401,727
Intangible assets, net
6,066,315
6,186,430
Goodwill
3,900,713
3,900,713
Other assets
282,000
282,000
Total assets
$
35,716,951
$
39,775,021
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable and accrued expenses
$
1,364,551
$
1,807,305
Accrued clinical trial expenses
617,222
573,767
Common stock warrants
340,626
367,071
Deferred revenue
468,309
544,410
Deferred rent
64,234
61,946
Total current liabilities
2,854,942
3,354,499
Deferred revenue, net of current portion
4,246,508
4,335,806
Deferred rent, net of current portion
81,938
99,712
Deferred tax liabilities
934,500
950,250
Total liabilities
8,117,888
8,740,267
Stockholders’ equity:
Preferred stock
113
113
Common stock
43,875
43,815
Additional paid-in capital
171,098,210
170,730,621
Receivables from stockholders
(50,000
)
(50,000
)
Accumulated deficit
(142,869,035
)
(139,847,326
)
Accumulated other comprehensive (loss) income
(624,100
)
157,531
Total stockholders’ equity
27,599,063
31,034,754
Total liabilities and stockholders’
equity
$
35,716,951
$
39,775,021
INOVIO BIOMEDICAL CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
Three Months EndedMarch 31, 2008
2007 Revenue:
License fee and milestone payments
$
192,829
$
234,489
Revenue under collaborative research and
development arrangements
460,185
247,990
Grant and miscellaneous revenue
—
21,423
Total revenue
653,014
503,902
Operating expenses:
Research and development
1,597,388
2,516,411
General and administrative
2,401,505
2,291,161
Total operating expenses
3,998,893
4,807,572
Loss from operations
(3,345,879
)
(4,303,670
)
Interest income
298,749
223,068
Other income (expense)
25,421
339,305
Net loss
(3,021,709
)
(3,741,297
)
Imputed and declared dividends on preferred stock
—
(15,091
)
Net loss attributable to common stockholders
$
(3,021,709
)
$
(3,756,388
)
Amounts per common share — basic and
diluted:
Net loss per share attributable to common stockholders
$
(0.07
)
$
(0.10
)
Weighted average number of common shares outstanding —
basic and diluted
43,837,739
37,694,634
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