Cougar Biotechnology, Inc. (NASDAQ: CGRB), a biotechnology
company engaged in the in-license and development of clinical stage
cancer drug candidates, today reported its financial results for
the first quarter ended March 31, 2009.
First Quarter 2009 Financial Results
For the quarter ended March 31, 2009, Cougar reported a net loss
applicable to common stock of $23.3 million, or $1.12 per share,
compared to a net loss applicable to common stock of $6.4 million,
or $0.31 per share, for the quarter ended March 31, 2008. Total
operating expenses for the first quarter of 2009 were $23.5
million, an increase of $15.8 million compared to the first quarter
of 2008.
Research and development expenses for the first quarter of 2009
were $20.1 million, compared to $5.9 million for the first quarter
of 2008. The increase in research and development expenses in the
first quarter of 2009 resulted primarily from costs associated with
the Company�s ongoing Phase III trial (COU-AA-301) of CB7630
(abiraterone acetate) in prostate cancer patients who have failed
treatment with chemotherapy, and the initiation of a Phase III
trial (COU-AA-302) of CB7630 in chemotherapy-na�ve prostate cancer
patients. Research and development expenses included $1.6 million
of non-cash stock-based compensation in the first quarter of 2009
versus a credit of $0.3 million in the first quarter of 2008.
General and administrative expenses for the first quarter of
2009 were $3.3 million, compared to $1.8 million for the first
quarter of 2008. The increase in expenses was attributable to
higher professional fees related to contract negotiations with
clinical sites involved with the Company�s Phase III trials, as
well as business development expenses. General and administrative
expenses in the first quarter of 2009 included $0.9 million of
employee non-cash stock-based compensation expense, which
represents an increase of $0.5 million from the first quarter of
2008.
Net cash used in operating activities in the first quarter of
2009 was $15.2 million, compared to $15.4 million in the fourth
quarter of 2008. As of March 31, 2009, cash, cash equivalents and
investment securities available-for-sale totalled $75.8 million,
compared to $91.0 million as of December 31, 2008. The decline from
the year-end 2008 balance is largely attributable to expenditures
required to advance our drug candidates through clinical trials and
the additional infrastructure needed to support our drug
development activities.
�During the first quarter of 2009, we achieved several important
milestones for the CB7630 program, including obtaining agreement
with the U.S. Food and Drug Administration under a Special Protocol
Assessment for a Phase III clinical trial of our lead drug
candidate CB7630 in chemotherapy-na�ve castration-resistant
prostate cancer patients, and soon thereafter initiating the
COU-AA-302 Phase III trial,� said Alan H. Auerbach, Chief Executive
Officer and President. �In addition, we continued to report
positive data from the ongoing CB7630 Phase II clinical trials at
the 2009 ASCO Genitourinary Cancers Symposium during the
quarter.
�We continue to be committed to maintaining our focus on
creating shareholder value during 2009 and we look forward to
continuing to aggressively advance our clinical program for CB7630.
More specifically, we look forward to continuing to progress our
two ongoing Phase III trials for CB7630 in prostate cancer and
advance our ongoing Phase I/II trial of CB7630 in breast cancer as
well. In 2009, we also anticipate reporting Phase I results from
the Phase I/II trial of CB3304 in multiple myeloma and potentially
initiating the Phase II portion of the trial,� Mr. Auerbach
added.
About Cougar Biotechnology
Cougar Biotechnology, Inc. is a Los Angeles-based biotechnology
company, established to in-license and develop clinical stage
drugs, with a specific focus on the field of oncology. Cougar�s
oncology portfolio includes CB7630, a targeted inhibitor of the
17alpha-hydroxylase/c17,20 lyase enzyme, which is currently being
tested in Phase III clinical trials in prostate cancer and a Phase
I/II trial in breast cancer; CB3304, an inhibitor of microtubule
dynamics, which is currently in a Phase I trial in multiple
myeloma; and CB1089, an analog of vitamin D, which has been
clinically tested in a number of solid tumor types.
Further information about Cougar Biotechnology can be found at
www.cougarbiotechnology.com.
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. These statements are often, but not always, made through the
use of words or phrases such as �anticipates,� �expects,� �plans,�
�believes,� �intends,� and similar words or phrases. These
forward-looking statements include, without limitation, statements
related to the timing, progress and anticipated results of the
clinical development, regulatory processes and the benefits to be
derived from Cougar�s drug development programs, including the
potential advantages of CB7630 and its potential for use in the
treatment of castration- resistant prostate cancer and in
second-line treatment settings. Such statements involve risks and
uncertainties that could cause Cougar�s actual results to differ
materially from the anticipated results and expectations expressed
in these forward-looking statements. These statements are only
predictions based on current information and expectations and
involve a number of risks and uncertainties. Actual events or
results may differ materially from those projected in any of such
statements due to various factors, including the risks and
uncertainties inherent in clinical trials, and drug development and
commercialization, including the uncertainty of whether results of
prior clinical trials of CB7630 will be predictive of results of
later stage clinical trials, including COU-AA-301 and COU-AA-302.
For a discussion of these and other factors, please refer to
Cougar�s annual report on Form 10-K for the year ended December 31,
2008, as well as other subsequent filings with the Securities and
Exchange Commission. You are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the
date hereof. This caution is made under the safe harbor provisions
of the Private Securities Litigation Reform Act of 1995. All
forward-looking statements are qualified in their entirety by this
cautionary statement and Cougar undertakes no obligation to revise
or update this press release to reflect events or circumstances
after the date hereof.
(Tables to Follow)
COUGAR BIOTECHNOLOGY, INC. (A DEVELOPMENT STAGE
COMPANY) CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS (in thousands, except per share
amounts) � � � Period from May 14, 2003 Three Months Ended (date of
March 31, inception) to � 2009 � � 2008 � March 31, 2009 �
Operating expenses: General and administrative $ 3,338 $ 1,755 $
26,899 Research and development 20,105 5,907 115,171 Depreciation �
74 � � 53 � � 435 � Totals � 23,517 � � 7,715 � � 142,505 � Loss
from operations � (23,517 ) � (7,715 ) � (142,505 ) Other income
(expenses): Interest income 159 1,316 7,313 Interest expense - -
(1,312 ) Other income (expense) � 38 � � (27 ) � (1,703 ) Net loss
(23,320 ) (6,426 ) (138,207 )
Accretion of dividends on
preferred stock
- - (1,583 )
Accretion of issuance costs on
preferred stock
� - � � - � � (445 ) Net loss applicable to common stock $ (23,320
) $ (6,426 ) $ (140,235 )
Net loss per common share - basic
and diluted
$ (1.12 ) $ (0.31 )
Weighted-average common shares
outstanding - basic and diluted
� 20,770,336 � � 20,550,882 � Comprehensive loss, net of tax: Net
loss $ (23,321 ) $ (6,427 ) $ (138,206 )
Other comprehensive income -
unrealized gain on investment securities
� (34 ) � - � � (15 ) Total comprehensive loss $ (23,355 ) $ (6,427
) $ (138,221 ) � �
COUGAR BIOTECHNOLOGY, INC. (A
DEVELOPMENT STAGE COMPANY) CONDENSED CONSOLIDATED BALANCE
SHEET DATA (in thousands) � March 31, December 31, � 2009 � �
2008 � Current assets: Cash and cash equivalents $ 48,186 $ 40,768
Investment securities available-for-sale, at fair value 27,616
50,226 Total assets 79,042 93,823 Total liabilities 18,645 12,687
Total stockholders� equity 60,397 81,136
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