Ardea Biosciences, Inc. (Nasdaq:RDEA), a biotechnology company
focused on the discovery and development of small-molecule
therapeutics for the treatment of gout, human immunodeficiency
virus (HIV), cancer and inflammatory diseases, today reported
recent accomplishments, announced fourth quarter and full-year 2008
financial results and provided key upcoming clinical development
milestones and financial guidance for 2009.
�Since our last annual update we have advanced all of our
clinical stage programs and replenished our balance sheet with two
successful financings in a very difficult funding environment. We
are particularly pleased with the progress we have made with
RDEA594, which we have successfully advanced through preclinical
development and into a series of Phase�1 clinical studies in
healthy volunteers. We plan to continue RDEA594�s rapid progress by
completing a Phase 2 dose-ranging study in gout patients in 2009.
The approximately $39 million added to our balance sheet in the
fourth quarter of 2008 from a growth capital loan and private
placement of common stock and warrants should allow us to fund
operations well beyond the expected completion of the Phase 2 study
without requiring any additional cash infusions,� commented Barry
D. Quart, PharmD, Ardea�s president and chief executive
officer.
Recent Accomplishments
- In December 2008, we completed a
single ascending dose Phase 1 clinical study of RDEA594 in normal
healthy volunteers, demonstrating that single doses of up to 600 mg
of RDEA594 were well tolerated, with linear increases in drug
levels observed throughout the dose ranges investigated, and with
up to an 11-hour elimination half life. A dose-related decrease in
serum uric acid was observed, with overall reductions compared to
placebo of up to 30% over the first 24 hours, which is about twice
that observed in prior studies with a single 800 mg dose of
RDEA806, RDEA594�s prodrug, given as an enteric-coated tablet;
- In December 2008, we completed a
$30.6 million gross proceeds private placement of 2,737,336 newly
issued shares of common stock and warrants to purchase 684,332
shares of common stock at a total purchase price of $11.17 per
unit, with each unit consisting of one share of common stock and
one warrant to purchase 0.25 shares of common stock;
- In November 2008, we received an
$8.0 million growth capital loan from Oxford Finance Corporation
and Silicon Valley Bank;
- In October 2008, based on
positive in vitro synergy data, we initiated a Phase 1/2 study of
RDEA119 in combination with sorafenib (Nexavar�, Onyx
Pharmaceuticals and Bayer HealthCare) in advanced cancer patients;
and
- We have continued to prepare
RDEA806 for further clinical development by obtaining additional
regulatory approvals to conduct our planned international Phase 2b
HIV study and by successfully completing a number of important
safety and toxicology studies including a Thorough QT study.
Results from the Thorough QT study demonstrated that QTc intervals
were not increased by any dose of RDEA806 tested. In addition, the
study provided information on the lack of pharmacokinetic
differences between Caucasians and African-Americans. These results
provide further support for RDEA806�s cardiac safety profile as
well as its potential to improve current standard-of-care therapy
as ethnicity-based differences in metabolism, which can lead to
increased side effects in African-Americans, have been documented
with efavirenz (Sustiva�, Bristol-Myers Squibb).
Important Upcoming Clinical Development Milestones
- Complete our ongoing multiple
ascending dose Phase 1 study of RDEA594 in normal healthy
volunteers in the first quarter of 2009;
- Complete our ongoing Phase 2a
proof-of-concept study of RDEA594�s prodrug, RDEA806, in the target
population of gout patients in the first quarter of 2009;
- Initiate a Phase 2 dose-ranging
study of RDEA594 in gout patients in the first half of 2009;
- Identify a clinical candidate
from our next generation URAT1 inhibitor program in the first half
of 2009;
- Complete and report results from
our ongoing Phase 1/2 study of RDEA119 in combination with
sorafenib in patients with advanced cancer in the second half of
2009;
- Complete and report results from
our ongoing Phase 1 monotherapy study of RDEA119 in patients with
advanced cancer in the second half of 2009; and
- Initiate a Phase 2b clinical
study of RDEA806 in HIV patients in 2009 following the
establishment of a corporate partnership.
2008 Financial Results
As of December 31, 2008, we had $57.7 million in cash, cash
equivalents, and short-term investments compared to $66.2�million
as of December�31, 2007. The decrease in cash, cash equivalents and
short-term investments for the year ended December 31, 2008 was due
to the use of our financial resources to fund our clinical and
preclinical programs, increased personnel costs, and for other
general corporate purposes, partially offset by the proceeds
received from our growth capital loan and the sale of equity
securities in the fourth quarter of 2008.
The net loss applicable to common stockholders for the three and
twelve months ended December 31, 2008 was $12.7 million and $55.1
million, or $0.82 per share and $3.79 per share, respectively,
compared to a net loss applicable to common stockholders for the
same periods in 2007 of $9.1 million and $25.3 million, or $0.86
per share and $2.55 per share, respectively. The net loss
applicable to common stockholders for the three and twelve months
ended December 31, 2008 included non-cash charges of $1.4 million
and $5.1 million, or $0.09 per share and $0.35 per share,
respectively, for stock-based compensation expense. For the same
periods in 2007, we reported non-cash charges of $0.6 million and
$1.4 million, or $0.05 per share and $0.14 per share, respectively,
for stock-based compensation expense. The increase in net loss
applicable to common stockholders and net loss applicable to common
stockholders per share between these periods was due primarily to
increased research and development expenses related to the
continued development and progression of our clinical and
preclinical programs, increased general and administrative expenses
to support that effort and our overall growth.
Revenue for the three and twelve months ended December 31, 2008
was $44,000 and $0.3 million, respectively, compared to $0.3
million and $3.1 million for the three and twelve months ended
December 31, 2007, respectively. Historically, our revenues have
resulted from the research services we have provided under our
master services agreement with Valeant Research and Development,
Inc. (Valeant). The decrease in revenues from 2007 levels is due to
the earlier than anticipated identification of a clinical
development candidate from that program and Valeant�s subsequent
reduction in the utilization of our research and development
services. The master services agreement has since terminated by its
terms.
Excluding the proceeds from our growth capital loan and sale of
equity securities in the fourth quarter of 2008, our cash usage for
2008 was $46.8 million, which was in line with previously provided
2008 cash usage guidance of between $45 million and $50
million.
2009 Financial Guidance
As of December�31, 2008, we had a total of $57.7�million in
cash, cash equivalents and short-term investments. Excluding any
proceeds that we may receive from future business development or
financing activities, we anticipate our 2009 cash usage to be
between $38�million and $43�million.
� � �
ARDEA BIOSCIENCES, INC.
�
Condensed Consolidated
Statements of Operations
(in thousands, except per share
amounts)
�
Three Months Ended
December 31,
(Unaudited)
Twelve Months Ended
December 31,
2008 � 2007 2008 � 2007 Collaboration revenues $ 44 $ 268 $ 304 $
3,095 � Operating expenses: Research and development 10,711 7,260
44,858 23,103 General and administrative � 1,994 � � 2,653 � �
11,921 � � 7,566 � Total operating expenses 12,705 9,913 56,779
30,669 � Loss from operations (12,661 ) (9,645 ) (56,475 ) (27,574
) � Other income, net: Interest income 210 440 1,524 2,128 Interest
expense (204 ) � (215 ) � Other income (expense) � (11 ) � 187 � �
171 � � 375 � Total other income, net (5 ) 627 1,480 2,503 � � � �
Net loss � (12,666 ) � (9,018 ) � (54,995 ) � (25,071 ) � Non-cash
dividends on Series A preferred stock �
�
� �
(60
)
�
(60
)
�
(240
)
� Net loss applicable to common stockholders $ (12,666 ) $ (9,078 )
$ (55,055 ) $ (25,311 ) � Basic and diluted net loss per share
applicable to common stockholders
$
(0.82
)
$
(0.86
)
$
(3.79
)
$
(2.55
)
�
Shares used in computing basic and
diluted net loss per share applicable to common stockholders
�
�
15,453
� �
�
10,583
� �
�
14,544
� �
�
9,934
� � � � � � � �
Condensed Consolidated Balance
Sheet Data
(in thousands)
� December 31,
2008
December 31,
2007
� Cash, cash equivalents and short-term investments $ 57,743 $
66,215 Total assets $ 61,475 $ 68,840 Total stockholders� equity $
45,958 $ 63,739 �
About Ardea Biosciences, Inc.
Ardea Biosciences, Inc., of San Diego, California, is a
biotechnology company focused on the discovery and development of
small-molecule therapeutics for the treatment of gout, HIV, cancer
and inflammatory diseases. We have five product candidates in
clinical trials and others in preclinical development and
discovery. Our most advanced product candidate is RDEA806, a
non-nucleoside reverse transcriptase inhibitor (NNRTI), which has
successfully completed a Phase 2a study for the treatment of
patients with HIV. We have evaluated our second-generation NNRTI
for the treatment of HIV, RDEA427, in a human micro-dose
pharmacokinetic study and have selected it for clinical development
based on a plasma half-life of greater than 40 hours. RDEA594, our
lead product candidate for the treatment of hyperuricemia and gout,
is being evaluated in Phase 1 clinical trials. We are evaluating
our lead MEK inhibitor, RDEA119, in a Phase 1/2 study in
combination with sorafenib (Nexavar�, Onyx Pharmaceuticals, Bayer
HealthCare) and as a single agent in a Phase 1 study, both in
advanced cancer patients, and have completed a Phase 1 study in
normal healthy volunteers as a precursor to trials in patients with
inflammatory diseases. Lastly, we have evaluated our
second-generation MEK inhibitor for the treatment of cancer and
inflammatory diseases, RDEA436, in a human micro-dose
pharmacokinetic study and have selected it for clinical
development.
Statements contained in this press release regarding matters
that are not historical facts are "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Such
statements include, but are not limited to, statements regarding
our plans and goals, the expected properties and benefits of
RDEA806, RDEA594, RDEA427, RDEA119, RDEA436 and our other compounds
and the timing and results of our preclinical, clinical and other
studies, sufficiency of our cash resources and our financial
performance. Risks that contribute to the uncertain nature of the
forward-looking statements include risks related to the outcome of
preclinical and clinical studies, risks related to regulatory
approvals, delays in commencement of preclinical and clinical
studies, costs associated with our drug discovery and development
programs, and risks related to the outcome of our business
development activities. These and other risks and uncertainties are
described more fully in our most recently filed SEC documents,
including our Annual Report on Form 10-K and our Quarterly Reports
on Form 10-Q, under the headings "Risk Factors." All
forward-looking statements contained in this press release speak
only as of the date on which they were made. We undertake no
obligation to update such statements to reflect events that occur
or circumstances that exist after the date on which they were
made.
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