CORRECTING and REPLACING Introgen Therapeutics Reports First Quarter 2008 Financial Results
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INTROGEN THERAPEUTICS REPORTS FIRST QUARTER 2008 FINANCIAL RESULTS
Introgen Therapeutics, Inc. (NASDAQ: INGN) announced today its financial
results for the quarter ended March 31, 2008.
During the quarter, the Company’s cash, cash
equivalents and short-term investments decreased $5.9 million as a
result of the use of those resources to conduct its business, which is
consistent with the anticipated decrease in the amount of these
resources consumed compared to the previous quarter ended December 31,
2007. Introgen’s cash, cash equivalents and
short-term investments were $16.5 million at March 31, 2008.
Revenue was $186,000 for the quarter ended March 31, 2008, compared to
revenue of $468,000 for the quarter ended December 31, 2007 and $322,000
for the quarter ended March 31, 2007. Operating expense was $7.2 million
for the quarter ended March 31, 2008, compared to operating expenses of
$10.3 million for the quarter ended December 31, 2007 and $6.4 million
for the quarter ended March 31, 2007, which includes $1.0 million, $2.2
million and $1.3 million, respectively, of expense related to
share-based compensation.
The Company’s net loss was $2.4 million, or
$0.05 per share, for the quarter ended March 31, 2008. These results
compare to a net loss of $9.5 million, or $0.22 per share, for the
previous quarter ended December 31, 2007 and a net loss of $5.6 million,
or $0.13 per share, for the comparable quarter ended March 31, 2007.
As we experience a reduction in certain ADVEXIN®
registration program expenses associated with completion of various
regulatory tasks, we anticipate using approximately $5.5 million of our
cash, cash equivalents and short-term investments to conduct our
business during the second quarter of 2008. In subsequent periods, we
anticipate efficiency gains in our activities that will allow us to
pursue our business objectives using approximately $5 million or less of
those resources per quarter.
ADVEXIN Phase 3 Data Presentations
We anticipate top line data from the Company’s
Phase 3 clinical trial will be presented in the second quarter 2008. The
primary objective of our Phase 3 study was to demonstrate safety,
efficacy and utility providing medical benefit for ADVEXIN in comparison
to Methotrexate, in patients with recurrent, refractory squamous cell
carcinoma of the head and neck.
These data will be the basis for ADVEXIN regulatory submissions in the
United States and in Europe during the second quarter of 2008.
About ADVEXIN
ADVEXIN p53 therapy is a targeted molecular therapy with broad
applicability in a wide range of tumor types and clinical settings
because it targets one of the most fundamental and common molecular
defects, abnormal p53 tumor suppressor function, associated with cancer
initiation, progression and treatment resistance. ADVEXIN has
demonstrated increased survival and tumor growth control in recurrent
head and neck cancer patients. ADVEXIN has demonstrated clinical
activity in a number of solid tumor types in multiple Phase 1, 2 and 3
clinical trials conducted worldwide.
Forward-Looking Statements
Statements in this release that are not strictly historical may be "forward-looking”
statements, including those relating to Introgen’s
future success with its ADVEXIN clinical and research programs for the
treatment of cancer, regulatory submissions in the U.S. and Europe and
Introgen’s financial performance. Only the FDA
and EMEA can determine whether ADVEXIN can be marketed in the United
States and Europe. The actual results may differ from those described in
this release due to risks and uncertainties that exist in Introgen’s
operations and business environment, including Introgen’s
stage of product development and the limited experience in the
development of gene-based drugs in general, dependence upon proprietary
technology and the current competitive environment, history of operating
losses and accumulated deficits, reliance on collaborative
relationships, and uncertainties related to clinical trials, the safety
and efficacy of Introgen’s product
candidates, the ability to obtain the appropriate regulatory approvals,
Introgen’s patent protection and market
acceptance, as well as other risks detailed from time to time in Introgen’s
filings with the Securities and Exchange Commission, including its
filings on Form 10-K and Form 10-Q. Introgen undertakes no obligation to
publicly release the results of any revisions to any forward-looking
statements that reflect events or circumstances arising after the date
hereof.
Editor's Note: For more information on Introgen Therapeutics, or for a
menu of archived press releases, please visit Introgen’s
website at www.introgen.com.
INTROGEN THERAPEUTICS, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEET
MARCH 31, DECEMBER 31, 2008 2007 (Unaudited)
(Thousands)
CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS $16,479 $14,905
MARKETABLE SECURITIES 0 10,165
OTHER CURRENT ASSETS 462 706
PROPERTY AND EQUIPMENT, NET 4,321 4,442
OTHER ASSETS 260 265
TOTAL ASSETS $21,522 $30,483
ACCOUNTS PAYABLE, ACCRUALS AND OTHER CURRENT LIABILITIES $6,903 $7,240
NOTES PAYABLE, NET OF CURRENT PORTION 7,014 7,155
OTHER LONG TERM LIABILITIES 22 79
TOTAL LIABILITIES 13,939 14,474
NON-CONTROLLING INTEREST IN CONSOLIDATED SUBSIDIARY 2 6
TOTAL STOCKHOLDERS' EQUITY 7,581 16,003
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $21,522 $30,483 INTROGEN THERAPEUTICS, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENT OF OPERATIONS (Unaudited)
THREE MONTHS ENDED MARCH 31, 2008 2007 (Thousands except per share information.)
CONTRACT SERVICES, GRANT AND OTHER REVENUE $186 $322
OPERATING EXPENSES: RESEARCH AND DEVELOPMENT 4,682 3,175 GENERAL AND ADMINISTRATIVE 2,531 3,267
TOTAL OPERATING EXPENSES 7,213 6,442
LOSS FROM OPERATIONS (7,027) (6,120)
REALIZED GAIN ON SALE OF MARKETABLE SECURITIES 4,388 0 INTEREST INCOME, INTEREST EXPENSE AND OTHER INCOME, NET 234 517
LOSS BEFORE NON-CONTROLLING INTEREST IN CONSOLIDATED SUBSIDIARY ($2,405) ($5,603)
NON-CONTROLLING INTEREST IN CONSOLIDATED SUBSIDIARY 4 (14)
NET LOSS (2,401) (5,617)
NET LOSS PER SHARE, BASIC AND DILUTED ($0.05) ($0.13)
SHARES USED IN COMPUTING BASIC AND DILUTED NET LOSS PER SHARE 44,007 43,655
