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
Second Quarter and Year-to-Date 2011 Financial ResultsAs 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
(Unaudited)Six Months Ended
(Unaudited)2011201020112010Revenues: License fees
4,853 Sponsored research132—222— Reimbursable research and development costs9671,0951,5711,942Total revenues2,1763,5213,9466,795Operating expenses: Research and development15,52712,88428,24223,135 General and administrative4,7693,3199,0186,246Total operating expenses20,29616,20337,26029,381Loss from operations(18,120)(12,682)(33,314)(22,586)Other income (expense): Interest income98111205180 Interest expense(98)(229)(232)(490) Other income, net613926Total other income (expense)6(105)(18)(284)Net loss
(22,870)Basic and diluted net loss per share
(1.11)Shares used in computing basic and diluted net loss per share 26,68722,55626,24120,568Condensed Consolidated Balance Sheet Data(in thousands)June 30,
2010Cash, cash equivalents and short-term investments
100,454Total stockholders' equity
77,123About 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.
|SOURCE Ardea Biosciences, Inc.|
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