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 announced fourth quarter and full-year 2011
financial results.
"The proceeds of $157.6 million from our recent financing, added
to our existing cash balance, put us in an excellent financial
position," commented Barry D. Quart, PharmD, Ardea's president and
chief executive officer. "We believe these resources should fund
operations beyond the estimated primary endpoint dates of all four
of the planned Phase 3 studies of lesinurad that are now fully
underway."
Recent Accomplishments
- On February 6, 2012, we completed an underwritten public
offering of approximately 9.8 million shares of our common stock,
including the full exercise of the underwriter's overallotment
option. Net proceeds from the sale of the shares, before expenses
and after deducting underwriting discounts and commissions, were
approximately $157.6 million.
- On December 19, 2011, we announced the initiation of the first
of four planned Phase 3 clinical trials in our development program
for lesinurad. The lesinurad Phase 3 development program is
expected to involve approximately 2,000 gout patients at sites
around the world. The remaining Phase 3 studies in the program
began shortly thereafter and are now fully underway.
- On November 7, 2011, we presented at the 2011 ACR/ARHP Annual
Scientific Meeting additional positive clinical results from the
ongoing extension period of a Phase 2b study (Study 203) of
lesinurad in combination with allopurinol. Since that meeting, all
patients continuing in the ongoing extension period of the Phase 2b
study have completed a total of 48 weeks of blinded treatment. Also
at that conference, we presented an analysis of the
pharmacokinetics, efficacy and safety profile of lesinurad in
patients with mild to moderate renal impairment, as well as initial
clinical results from a Phase 1 study of RDEA3170, our
next-generation URAT1 inhibitor. Highlights from these
presentations included:
- Results from the ongoing extension period of Study 203
demonstrated consistent, sustained reductions in serum urate (sUA)
levels, with 90 percent of patients on combination therapy at week
44 reaching the medically recommended target of sUA less than 6
mg/dL. Study 203 evaluates lesinurad in combination with
allopurinol in gout patients with elevated sUA who did not
adequately reach target sUA levels on standard doses of allopurinol
alone. The combination of lesinurad and allopurinol has been
generally well tolerated in this study, with adverse events similar
to allopurinol alone.
- Results from multiple completed studies demonstrated that the
sUA-lowering effects of lesinurad in gout patients with mild to
moderate renal impairment were consistent with that of patients
with normal renal function. Lesinurad was generally well tolerated
in these studies with a similar safety profile in subjects with
normal or impaired renal function.
- Initial results from a Phase 1 study in healthy volunteers of
RDEA3170, our next-generation product candidate for the treatment
of gout, demonstrated a greater than 60 percent mean decrease in
sUA, which was sustained for 36 hours, with a single 40 mg
dose.
Fourth Quarter and Year-End 2011 Financial
Results
As of December 31, 2011, we had $96.0 million in cash, cash
equivalents and short-term investments and $1.4 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 and decrease in receivables in 2011 was due primarily
to our February 2011 public offering of common stock, which
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.
Revenues totaled $1.7 million and $7.3 million for the three and
twelve months ended December 31, 2011, respectively, and $17.3
million and $27.4 million for the three and twelve months ended
December 31, 2010, respectively. The decrease in revenues in 2011
as compared to 2010 was primarily due to the recognition in the
fourth quarter of 2010 of the first $15.0 million milestone payment
under our license agreement with Bayer. There were no milestones
recognized in 2011. In addition, the decrease was due to an
extension of the estimated time period required to complete our
obligations under the license agreement to June 2012, which is the
period over which we are now recognizing the remaining portion of
the upfront license fee.
For the three and twelve months ended December 31, 2011, total
operating expenses increased to $32.5 million and $94.0 million,
respectively, from $17.8 million and $68.6 million for the same
periods in 2010. Total operating expenses for the three and twelve
months ended December 31, 2011 included non-cash, stock-based
compensation charges of $2.8 million, or $0.10 per share, and $10.6
million, or $0.40 per share, respectively, compared to $1.8
million, or $0.08 per share, and $10.8 million, or $0.49 per share,
for the same periods in 2010. The increase in total operating
expenses between the three and twelve months ended December 31,
2011, compared to the same periods in 2010, was primarily a result
of an increase in development expenses due to the progression of
lesinurad into Phase 3 clinical studies and the initiation of a
Phase 1 study for our next-generation product candidate for the
chronic treatment of gout, RDEA3170, as well as an increase in
consulting and professional outside services and personnel and
related costs to support these increased development
activities.
Net loss for the three and twelve months ended December 31, 2011
was $30.8 million, or $1.15 per share, and $86.6 million, or $3.26
per share, respectively, compared to a net loss for the same
periods in 2010 of $0.6 million, or $0.03 per share, and $41.6
million, or $1.91 per share. The increase in net loss between the
three-month periods and the twelve-month periods was due primarily
to the revenue and operating expense fluctuations described above.
The increase in net loss per share for the three and twelve months
ended December 31, 2011 compared to the same periods in 2010 was
mainly due to the increase in net loss 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 Twelve Months Ended
December 31, December 31,
(Unaudited)
-------------------- --------------------
2011 2010 2011 2010
--------- --------- --------- ---------
Revenues:
Milestones $ -- $ 15,000 $ -- $ 15,000
License fees 1,076 1,077 4,306 8,100
Sponsored research 73 358 391 358
Reimbursable research and
development costs 520 896 2,608 3,961
--------- --------- --------- ---------
Total revenues 1,669 17,331 7,305 27,419
Operating expenses:
Research and development 26,890 14,288 74,425 52,110
General and administrative 5,614 3,538 19,539 16,452
--------- --------- --------- ---------
Total operating expenses* 32,504 17,826 93,964 68,562
Loss from operations (30,835) (495) (86,659) (41,143)
Other income (expense):
Interest income 83 84 383 364
Interest expense (22) (172) (314) (866)
Other income, net -- (13) 9 14
--------- --------- --------- ---------
Total other income (expense) 61 (101) 78 (488)
--------- --------- --------- ---------
Net loss $ (30,774) $ (596) $ (86,581) $ (41,631)
========= ========= ========= =========
Basic and diluted net loss per
share $ (1.15) $ (0.03) $ (3.26) $ (1.91)
========= ========= ========= =========
Shares used in computing basic
and diluted net loss per share 26,867 23,214 26,543 21,823
========= ========= ========= =========
* Includes $2.8 million and $10.6 million in non-cash, stock-based
compensation expense, for the three and twelve months ended December 31,
2011, respectively, as compared to $1.8 million and $10.8 million,
respectively, for the same periods in 2010.
Condensed Consolidated Balance Sheet Data
(in thousands)
December 31, December 31,
2011 2010
-------------- ----------------
Cash, cash equivalents and short-term
investments $ 95,996 $ 80,612
Total assets $ 104,229 $ 100,454
Total stockholders' equity $ 82,247 $ 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, our lead product
candidate for the chronic treatment of gout, is a once-daily, oral
inhibitor of the URAT1 transporter that has entered Phase 3
clinical development. Our next-generation URAT1 inhibitor,
RDEA3170, is currently in Phase 1 clinical development. BAY 86-9766
(RDEA119) is a potent and specific inhibitor of mitogen-activated
ERK kinase (MEK) for the treatment of cancer being developed by
Bayer HealthCare under a global license agreement with Ardea. 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, BAY 86-9766 (RDEA119), RDEA3170 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.
Contact: John Beck Ardea Biosciences, Inc. (858) 652-6523
Email Contact
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