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 fourth quarter and year ended December 31, 2008.
For the quarter ended December 31, 2008, Cougar reported a net
loss applicable to common stock of $21.5 million, or $1.04 per
share, compared to a net loss applicable to common stock of $7.7
million, or $0.43 per share, for the quarter ended December 31,
2007. Net loss applicable to common stock for the year ended
December 31, 2008, was $59.8 million, or $2.90 per share, compared
to a net loss of $32.2 million, or $2.17 per share, for the year
ended December 31, 2007.
Total operating expenses for the fourth quarter of 2008 were
$21.9 million, an increase of $13.3 million compared to the fourth
quarter of 2007. Included in the total operating expenses for the
fourth quarters of 2008 and 2007 were non-cash stock-based
compensation expenses of $1.5 million and $2.0 million,
respectively. Total operating expenses for the year ended December
31, 2008, were $63.1 million, compared to $34.1 million in 2007, an
increase of $29.0 million. Total operating expenses for the years
ended December 31, 2008 and 2007, included non-cash stock-based
compensation expenses of $5.4 million and $7.0 million,
respectively. The increase in operating expenses in 2008 was
primarily driven by clinical development expenses for CB7630
(abiraterone acetate) and increased headcount, principally related
to growth in the company's clinical development and regulatory
affairs departments.
Research and development expenses for the fourth quarter of 2008
were $18.4 million, compared to $6.7 million for the fourth quarter
of 2007. Research and development expenses for the fourth quarters
of 2008 and 2007 included non-cash stock-based compensation
expenses of $0.6 million and $1.5 million, respectively. Total
research and development expenses for the year ended December 31,
2008, were $52.9 million, compared to $27.3 million in 2007. The
increase in research and development expenses in the fourth quarter
of 2008 was primarily driven by the costs of our ongoing Phase III
trial for our lead compound CB7630 in metastatic
castration-resistant prostate cancer patients who have failed
docetaxel-based chemotherapy (COU-AA-301), as well as the costs
associated with preparing for our anticipated Phase III trial of
CB7630 in metastatic castration-resistant prostate cancer patients
who have not yet received chemotherapy (COU-AA-302). Research and
development expenses for the years ended December 31, 2008 and
2007, included non-cash stock-based compensation expenses of $2.8
million and $5.9 million, respectively.
General and administrative expenses for the fourth quarter of
2008 were $3.4 million, compared to $1.8 million for the fourth
quarter of 2007. General and administrative expenses for the fourth
quarters of 2008 and 2007 included non-cash stock-based
compensation expenses of $0.9 million and $0.5 million,
respectively. Total general and administrative expenses for the
year ended December 31, 2008, were $10.0 million, compared to $6.8
million in 2007. General and administrative expenses for the years
ended December 31, 2008 and 2007, included non-cash stock-based
compensation expenses of $2.6 million and $1.5 million,
respectively.
Net cash used in operating activities for the year ended
December 31, 2008, was $44.7 million, compared to $23.1 million in
2007. Net cash used in operating activities for the quarter ended
December 31, 2008, was $15.4 million compared to $8.2 million in
the corresponding period of 2007. The increased use of cash for
both the quarter and year to date is primarily due to the ongoing
costs of our COU-AA-301 Phase III trial, as well as the costs
associated with preparation for our COU-AA-302 Phase III trial. As
of December 31, 2008, cash, cash equivalents and investment
securities available-for-sale totalled $91.0 million, compared to
$135.3 million as of December 31, 2007. The decline from the
December 31, 2007, balance largely reflects the expenditures
required to advance our drug candidates through their various
clinical trials and the additional infrastructure needed to support
the advancement of our drug candidates.
�2008 brought many significant achievements and advancements for
Cougar, as our lead drug candidate CB7630, abiraterone acetate,
entered into Phase III clinical trials and we continued to report
positive Phase I and Phase II data for CB7630 at various medical
conferences throughout the year,� said Alan H. Auerbach, Chief
Executive Officer and President.
�We will continue to move forward aggressively with the clinical
development of CB7630 during 2009. Our ongoing COU-AA-301 Phase III
trial of CB7630 in patients with metastatic castration-resistant
prostate cancer who have failed docetaxel-based chemotherapy has
experienced rapid recruitment and we look forward to completing
recruitment in this trial shortly. We were also very pleased to
announce last month that we reached agreement with the U.S. Food
and Drug Administration under a Special Protocol Assessment for our
planned Phase III clinical trial of CB7630 in patients with
chemotherapy na�ve castration-resistant prostate cancer and we look
forward to initiating this Phase III trial (COU-AA-302) shortly. We
also anticipate that we will present preliminary data from our
Phase I/II trial of CB7630 in breast cancer during 2009 and further
anticipate that we will report preliminary data from our Phase I/II
trial of CB3304 (noscapine) in multiple myeloma during the year as
well," added Mr. Auerbach.
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 a Phase III clinical trial 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, its potential for use in the
treatment of castration resistant prostate cancer and in
second-line hormone and chemotherapy-na�ve treatment settings, and
the timing of presenting data from our ongoing clinical trials.
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. 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.
COUGAR BIOTECHNOLOGY, INC. (A DEVELOPMENT STAGE
COMPANY) CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS (in thousands, except per share amounts) � �
Period from May 14, 2003 Three Months Ended Year Ended (date of
December 31, December 31, inception) to � 2008 � � 2007 � � 2008 �
� 2007 � December 31, 2008 (unaudited) Operating expenses: General
and administrative $ 3,427 $ 1,825 $ 9,961 $ 6,786 $ 23,561
Research and development 18,435 6,709 52,892 27,277 95,066
Depreciation � 68 � � 34 � � 243 � � 83 � � 361 � Totals � 21,930 �
� 8,568 � � 63,097 � � 34,147 � � 118,987 � Loss from operations �
( 21,930 ) � ( 8,568 ) � ( 63,097 ) � ( 34,147 ) � ( 118,987 )
Other income (expenses): Interest income 343 874 3,097 2,775 7,155
Interest expense - - - - ( 1,312 ) Other income (expense) � 119 � �
- � � 182 � � ( 486 ) � ( 1,741 ) Net loss ( 21,468 ) ( 7,695 ) (
59,817 ) ( 31,858 ) ( 114,886 ) Accretion of dividends on preferred
stock - - - ( 310 ) (1,584 ) Accretion of issuance costs on
preferred stock � - � � - � � - � � ( 81 ) � (445 )
Net loss applicable to common
stock
$ ( 21,468 ) $ ( 7,695 ) $ ( 59,817 ) $ ( 32,249 ) $ ( 116,915 )
Net loss per common share - basic and diluted $ (1.04 ) $ (0.43 ) $
(2.90 ) $ (2.17 ) Weighted-average common shares outstanding -
basic and diluted � 20,693,593 � � 17,874,770 � � 20,640,413 � �
14,887,723 � Comprehensive loss, net of tax: Net loss $ ( 21,468 )
$ ( 7,695 ) $ ( 59,817 ) $ ( 31,858 ) $ ( 114,886 ) Other
comprehensive income - unrealized gain on investment securities �
19 � � - � � 19 � � - � � 19 � Total comprehensive loss $ ( 21,449
) $ ( 7,695 ) $ ( 59,798 ) $ ( 31,858 ) $ ( 114,867 ) �
COUGAR
BIOTECHNOLOGY, INC. (A DEVELOPMENT STAGE COMPANY)
BALANCE SHEET DATA (in thousands) � � December 31, December
31, 2008 2007 Current assets: Cash and cash equivalents $ 40,768 $
96,336 Investment securities available-for-sale, at fair value
50,226 39,002 Total assets 93,823 138,307 Total liabilities 12,687
3,628 Total stockholders� equity 81,136 134,679
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