Introgen Therapeutics Reports Second Quarter 2008 Financial Results and Recent Corporate Highlights
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Introgen Therapeutics, Inc. (NASDAQ: INGN), a developer of targeted
molecular therapies for cancer, announced today its financial results
for the quarter and six months ended June 30, 2008, and highlighted
recent corporate and product developments.
Recent Highlights
Announced positive data from Phase III clinical trial of ADVEXIN®
therapy for recurrent, refractory head and neck cancer, and presented
supporting survival data at the American Society of Gene Therapy
Annual Meeting and the American Association for Cancer Research’s
Cancer Clinical Trials and Personalized Medicine Conference
ADVEXIN demonstrated a statistically significant increased
survival benefit compared to methotrexate in p53 biomarker
population
ADVEXIN demonstrated a statistically significant increase in tumor
response compared to methotrexate in p53 biomarker population
ADVEXIN is well tolerated with less serious side effects compared
to conventional cancer therapies
ADVEXIN and methotrexate are effective in different and
complementary groups of patients dependent upon patients’
p53 biomarker profiles
Submitted ADVEXIN Biologics License Application (BLA) to the United
States Food and Drug Administration (FDA) and Marketing Authorization
Application (MAA) to the European Medicines Evaluation Agency (EMEA)
Established Introgen Technical Services to pursue contract production,
process development and manufacturing services
Formed strategic alliance with the Texas A&M University System to
address opportunities for process development and production of
therapeutics, vaccines, delivery systems and devices for human and
veterinary applications.
Second Quarter 2008 Financial Results
During the quarter, the company’s cash, cash
equivalents and short-term investments decreased $5.5 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 as compared to the quarter ended June 30, 2007.
Introgen’s cash, cash equivalents and
short-term investments were $11.0 million at June 30, 2008.
Revenue was $121,000 for the quarter ended June 30, 2008, compared to
revenue of $82,000 for the quarter ended June 30, 2007. Operating
expense was $6.6 million for the quarter ended June 30, 2008, compared
to operating expense of $8.3 million for the quarter ended June 30,
2007, which includes $1.1 million and $1.5 million, respectively, of
expense related to share-based compensation. Operating expense for the
second quarter declined primarily as a result of the completion of
activities associated with the ADVEXIN®
regulatory filings in both the U.S. and Europe.
The company’s net loss was $6.3 million, or
$0.14 per share, for the quarter ended June 30, 2008. These results
compare to a net loss of $7.7 million, or $0.18 per share, for the
comparable quarter ended June 30, 2007.
Six Months Financial Results
Revenue was $307,000 for the six months ended June 30, 2008, compared to
revenue of $404,000 for the six months ended June 30, 2007. Operating
expense was $13.9 million for the six months ended June 30, 2008,
compared to operating expenses of $14.7 million for the six months ended
June 30, 2007, which includes $2.2 million and $2.8 million,
respectively, of expense related to share-based compensation.
The company’s net loss was $8.7 million, or
$0.20 per share, for the six months ended June 30, 2008. These results
compare to a net loss of $13.4 million, or $0.31 per share, for the six
months ended June 30, 2007.
About Introgen
Introgen Therapeutics, Inc. is a biopharmaceutical company focused on
the discovery, development and commercialization of targeted molecular
therapies for the treatment of cancer and other diseases. Introgen is
developing molecular therapeutics, immunotherapies, vaccines and
nano-particle tumor suppressor therapies to treat a wide range of
cancers using tumor suppressors, cytokines and genes. Introgen maintains
integrated research, development, manufacturing, clinical and regulatory
departments and operates multiple manufacturing facilities including a
commercial scale cGMP manufacturing facility.
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
JUNE 30, DECEMBER 31, 2008 2007 (Unaudited)
(Thousands)
CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS $ 11,016 $ 14,905
MARKETABLE SECURITIES 0 10,165
OTHER CURRENT ASSETS 535 706
PROPERTY AND EQUIPMENT, NET 4,074 4,442
OTHER ASSETS
253
265
TOTAL ASSETS $ 15,878 $ 30,483
ACCOUNTS PAYABLE, ACCRUALS AND OTHER CURRENT LIABILITIES $ 6,474 $ 7,240
NOTES PAYABLE, NET OF CURRENT PORTION 7,022 7,155
OTHER LONG TERM LIABILITIES
6
79
TOTAL LIABILITIES
13,502
14,474
NON-CONTROLLING INTEREST IN CONSOLIDATED SUBSIDIARY 2 6
TOTAL STOCKHOLDERS' EQUITY
2,374
16,003
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 15,878 $ 30,483 INTROGEN THERAPEUTICS, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENT OF OPERATIONS (Unaudited)
THREE MONTHS ENDED SIX MONTHS ENDED JUNE 30,
JUNE 30,
2008
2007
2008
2007
(Thousands except per share information.)
CONTRACT SERVICES, GRANT AND OTHER REVENUE $ 121
$ 82
$ 307
$ 404
OPERATING EXPENSES: RESEARCH AND DEVELOPMENT 4,154 4,763 8,836 7,938 GENERAL AND ADMINISTRATIVE
2,490
3,533
5,021
6,800
TOTAL OPERATING EXPENSES
6,644
8,296
13,857
14,738
LOSS FROM OPERATIONS (6,523 ) (8,214 ) (13,550 ) (14,334 )
REALIZED GAIN ON SALE OF MARKETABLE SECURITIES 0 0 4,388 0 INTEREST INCOME, INTEREST EXPENSE AND
OTHER INCOME, NET
177
451
411
968
LOSS BEFORE NON-CONTROLLING INTEREST IN CONSOLIDATED SUBSIDIARY
($6,346 )
($7,763 )
($8,751 )
($13,366 )
NON-CONTROLLING INTEREST IN CONSOLIDATED SUBSIDIARY
0
14
4
0
NET LOSS
(6,346 )
(7,749 )
(8,747 )
(13,366 )
NET LOSS PER SHARE, BASIC AND DILUTED
($0.14 )
($0.18 )
($0.20 )
($0.31 )
SHARES USED IN COMPUTING BASIC AND DILUTED NET LOSS PER SHARE
44,014
43,801
44,010
43,728