SAN DIEGO, Aug. 5, 2011 /PRNewswire/ -- Ardea Biosciences,
Inc. (Nasdaq: RDEA), a biotechnology company focused on the
development of small-molecule therapeutics for the treatment of
serious diseases, today reported recent accomplishments and
financial results for the second quarter and six months ended
June 30, 2011.
"Since our last quarterly update, we presented exciting initial
results from the ongoing extension portion of our Phase 2b trial of
lesinurad demonstrating high rates of sustained uric acid lowering
and patient response over week 28 of the study at all doses,"
commented Barry D. Quart, PharmD, president and chief executive
officer. "These results, together with the impressive efficacy and
safety profile established in previous studies, position lesinurad
very well for our upcoming Phase 3 clinical studies."
Recent Accomplishments and Important Upcoming Events
- In May 2011, we presented
additional positive results from the primary dosing and ongoing
extension periods of our Phase 2b study (Study 203) adding
lesinurad to allopurinol in patients who did not achieve target
serum urate (sUA) levels on allopurinol alone, as well as other
preclinical and clinical data from our lesinurad development
program, at the Annual European Congress of Rheumatology hosted by
the European League Against Rheumatism (EULAR). Highlights
included:
- Results from the ongoing, blinded extension portion of Study
203 showed that 91 percent of patients receiving lesinurad in
combination with allopurinol achieved sUA levels below the
clinically important target of 6 mg/dL after 28 weeks of dosing. In
addition, continued reductions in sUA were observed beyond the
initial 28 days of dosing with the majority of the responding
patients remaining on the 200 mg dose of lesinurad thus far in the
extension portion. The combination has been generally well
tolerated in the ongoing extension portion of Study 203.
- Results from the completed 28-day main portion of the study
showing, at the highest lesinurad dose tested, the number of
patients taking the combination who achieved the target sUA level
of below 6 mg/dL was more than three times the number of patients
who achieved the target on allopurinol alone. This translated into
an overall response rate of 87 percent using a "last observation
carried forward", or LOCF, analysis. The combination of lesinurad
and allopurinol was generally well tolerated in the 28-day main
portion of Study 203.
- Results from a completed preclinical study showing that
lesinurad is an active inhibitor of the OAT4 transporter, a uric
acid transporter in the kidney believed to be responsible for the
hyperuricemia caused by the anti-hypertensive diuretic agent,
hydrochlorothiazide. As hypertension is a common co-morbid
condition in gout patients, this secondary lesinurad activity may
benefit gout patients taking this common treatment for
hypertension. Consistent with these preclinical results, a high
level of response was observed with lesinurad in the subset of
patients receiving thiazide diuretics in Study 203.
- In June 2011, we presented data
from a completed, multi-center, Phase 1, monotherapy,
dose-escalation study of BAY-86-9766 (RDEA119) in advanced cancer
patients at the 2011 American Society of Clinical Oncology (ASCO)
Annual Meeting. BAY 86-9766 (RDEA119) is a potent and highly
selective inhibitor of mitogen-activated ERK kinase (MEK) for the
treatment of cancer being developed under a global license
agreement with Bayer Healthcare.
- We are currently preparing for the commencement of Phase 3
studies of lesinurad which will focus on patients who do not reach
target serum uric acid levels with, or are intolerant to, the
current standard of care, allopurinol. In anticipation of
these studies, we recently initiated two observational studies in
patients with chronic gout who will receive allopurinol.
Given the low response rate typically observed with
allopurinol and its well established side effect profile, we expect
a substantial number of patients from these studies will be
eligible to enroll directly into our Phase 3 studies.
- During the third quarter of 2011, we expect to report the
results of an "End of Phase 2" meeting with the FDA for
lesinurad.
- Our next generation URAT1 inhibitor for gout, RDEA3170, has
received regulatory approval for Phase 1 dosing, which we expect
will commence in the third quarter of 2011.
Second Quarter and Year-to-Date 2011 Financial
Results
As of June 30, 2011, we had
$141.3 million in cash, cash
equivalents and short-term investments and $1.7 million in receivables, compared to
$80.6 million in cash, cash
equivalents and short-term investments and $17.0 million in receivables as of
December 31, 2010.
The net increase in cash, cash equivalents and short-term
investments in 2011 was due primarily to our public offering of
common stock, which was completed in February 2011 and resulted in net proceeds to us
of $78.1 million, and the receipt in
January 2011 of a $15.0 million milestone payment under our global
license agreement with Bayer HealthCare (Bayer). These
increases were partially offset by the use of cash to fund our
clinical-stage programs, personnel costs and for other general
corporate purposes. The decrease in receivables in this
period was due to the receipt of the $15.0
million milestone payment from Bayer.
Revenues totaled $2.2 million and
$3.9 million for the three and six
months ended June 30, 2011,
respectively, and $3.5 million and
$6.8 million for the three and six
months ended June 30, 2010,
respectively. The revenue earned in 2010 and 2011 was
primarily from the recognition of a portion of the $35.0 million upfront, non-refundable license fee
and reimbursement of third-party development costs under our global
license agreement with Bayer. The decrease in revenues for
the three and six months ended June 30,
2011 was due primarily to an increase in our estimate of the
time period required to complete our obligations under the license
agreement to June 2012, which is the
period over which we are recognizing the remaining portion of the
upfront license fee.
For the three and six months ended June
30, 2011, total operating expenses increased to $20.3 million and $37.3
million, respectively, from $16.2
million and $29.4 million for
the same periods in 2010. Total operating expenses for the
three and six months ended June 30, 2011 included non-cash,
stock-based compensation charges of $2.8
million, or $0.10 per share,
and $5.2 million, or $0.20 per share, respectively, compared to
$1.8 million, or $0.08 per share, and $3.5
million, or $0.17 per share,
for the same periods in 2010. The increase in total operating
expenses between the three and six months ended June 30, 2011, compared to the same periods in
2010, was primarily a result of an increase in research and
development expense due to the continued development and
progression of lesinurad and our next-generation product candidate
for the chronic management of hyperuricemia in gout patients,
RDEA3170 and the increase in non-cash stock-based compensation
expense noted above as well as consulting and professional outside
services increases and increased personnel and related
expenses.
Net loss for the three and six months ended June 30, 2011 was $18.1
million, or $0.68 per share,
and $33.3 million, or $1.27 per share, respectively, compared to a net
loss for the same periods in 2010 of $12.8
million, or $0.57 per share,
and $22.9 million, or $1.11 per share. The increase in net loss
per share for the three and six months ended June 30, 2011 compared to the same periods in
2010 was mainly due to the increase in operating expenses noted
above, partially offset by an increase in weighted-average shares
outstanding in 2011 as a result of our April 2010 and
February 2011 public offerings of
common stock.
ARDEA
BIOSCIENCES, INC.
Condensed
Consolidated Statements of Operations
(in
thousands, except per share amounts)
|
|
|
Three Months
Ended
June
30,
(Unaudited)
|
|
Six Months
Ended
June
30,
(Unaudited)
|
|
|
|
2011
|
|
|
2010
|
|
|
2011
|
|
|
2010
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
License fees
|
$
|
1,077
|
|
$
|
2,426
|
|
$
|
2,153
|
|
$
|
4,853
|
|
Sponsored research
|
|
132
|
|
|
—
|
|
|
222
|
|
|
—
|
|
Reimbursable research and
development costs
|
|
967
|
|
|
1,095
|
|
|
1,571
|
|
|
1,942
|
|
Total revenues
|
|
2,176
|
|
|
3,521
|
|
|
3,946
|
|
|
6,795
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
15,527
|
|
|
12,884
|
|
|
28,242
|
|
|
23,135
|
|
General and
administrative
|
|
4,769
|
|
|
3,319
|
|
|
9,018
|
|
|
6,246
|
|
Total
operating expenses
|
|
20,296
|
|
|
16,203
|
|
|
37,260
|
|
|
29,381
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
(18,120)
|
|
|
(12,682)
|
|
|
(33,314)
|
|
|
(22,586)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
98
|
|
|
111
|
|
|
205
|
|
|
180
|
|
Interest expense
|
|
(98)
|
|
|
(229)
|
|
|
(232)
|
|
|
(490)
|
|
Other income, net
|
|
6
|
|
|
13
|
|
|
9
|
|
|
26
|
|
Total other
income (expense)
|
|
6
|
|
|
(105)
|
|
|
(18)
|
|
|
(284)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
$
|
(18,114)
|
|
$
|
(12,787)
|
|
$
|
(33,332)
|
|
$
|
(22,870)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per
share
|
$
|
(0.68)
|
|
$
|
(0.57)
|
|
$
|
(1.27)
|
|
$
|
(1.11)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic
and diluted net loss per share
|
|
26,687
|
|
|
22,556
|
|
|
26,241
|
|
|
20,568
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed
Consolidated Balance Sheet Data
(in
thousands)
|
|
|
|
June
30,
2011
(unaudited)
|
|
|
December
31,
2010
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and
short-term investments
|
$
|
141,321
|
|
$
|
80,612
|
|
Total assets
|
$
|
147,579
|
|
$
|
100,454
|
|
Total stockholders'
equity
|
$
|
128,867
|
|
$
|
77,123
|
|
|
|
|
|
|
|
|
|
About Ardea Biosciences, Inc.
Ardea Biosciences, Inc., of San Diego,
California, is a biotechnology company focused on the
development of small-molecule therapeutics for the treatment of
serious diseases. Lesinurad (RDEA594), our lead product candidate
for the chronic management of hyperuricemia in patients with gout,
is a once-daily, oral inhibitor of the URAT1 transporter. We
have completed Phase 2b clinical studies of lesinurad and continue
to advance the drug in longer term extensions in preparation for
Phase 3 development. Our next-generation URAT1 inhibitor,
RDEA3170, is currently in preclinical development. BAY 86-9766
(RDEA119) is a potent and specific inhibitor of mitogen-activated
ERK kinase (MEK) for the treatment of cancer being developed under
a global license agreement with Bayer HealthCare. BAY 86-9766
(RDEA119) is currently in a Phase 2 study in patients with
hepatocellular carcinoma in combination with sorafenib and a Phase
1/Phase 2 study in patients with advanced pancreatic cancer in
combination with gemcitabine.
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
lesinurad (RDEA594), BAY 86-9766 (RDEA119) and our other compounds
and the timing and results of our preclinical, clinical and other
studies. 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, including collaboration or license
agreements. 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.
(Logo:
http://photos.prnewswire.com/prnh/20091104/ARDEALOGO)
SOURCE Ardea Biosciences, Inc.