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Ardea Biosciences, Inc. Reports Third Quarter 2007 Operating and Financial Results

Posted on: Wednesday, 14 November 2007, 18:00 CST

CARLSBAD, Calif., Nov. 14 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. ("Ardea" or the "Company") , a company focused on the discovery and development of small-molecule therapeutics for the treatment of viral diseases, cancer and inflammatory diseases, today reported financial and operating results for the three months and nine months ended September 30, 2007.

Ardea reported a loss applicable to common stockholders of $7.4 million ($0.72 per basic and diluted share) on revenues of $1.1 million for the third quarter of 2007, compared to a profit of $116,000 ($0.01 per share) for the third quarter of 2006. For the nine months ended September 30, 2007, the Company lost $16.2 million ($1.67 per basic and diluted share) on revenues of $2.8 million, compared to a loss of $131,000 ($0.01 per share) for the corresponding nine-month period in 2006. During 2006, the Company had no revenue. The results for the quarter and nine months ended September 30, 2007 include respective non-cash charges of $421,000 ($0.04 per share) and $784,000 ($0.08 per share) for stock compensation expense. The difference between 2007 and 2006 results reflects Ardea's re-start and rebuilding of operations.

"This past quarter proved to be highly productive," said Barry D. Quart, President and CEO. "We made significant progress in advancing our business and in the development of our pipeline, achieving several important milestones." These include:

-- Completion of Phase 1 single-ascending-dose, multiple-ascending-dose, food-effect, and drug-interaction clinical studies of RDEA806, our lead non-nucleoside reverse transcriptase inhibitor (NNRTI) for HIV, in August of 2007; -- Presentation of four posters describing the favorable results of preclinical and Phase 1 clinical trials with RDEA806 during the 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); -- Completion, submission and FDA approval of our investigational new drug application (IND) for our lead mitogen-activated ERK kinase (MEK) inhibitor, RDEA119, allowing us to proceed to Phase 1 clinical trials in advanced cancer patients; and -- Presentation of RDEA119 preclinical data, showing favorable properties, including oral dosing, excellent selectivity and low central nervous system (CNS) penetration, at the American Association of Cancer Research (AACR), National Cancer Institute (NCI) and European Organization for Research and Treatment of Cancer (EORTC) International Conference on Molecular Targets and Cancer Therapeutics.

"We are well positioned for continued progress and success with our development programs in viral diseases, cancer and inflammatory diseases and are working to achieve several milestones in the next few months," added Dr. Quart. These include:

-- Initiation of a Phase 2a proof-of-concept trial with our lead NNRTI, RDEA806; -- Assessing a next-generation NNRTI from our follow-on program in a first-in-human micro-dosing study; -- Initiation of a Phase 1 advanced cancer clinical study of our lead MEK inhibitor, RDEA119; -- Initiation of a program to evaluate RDEA119 in inflammatory diseases; and -- Assessing a next-generation MEK inhibitor from our follow-on program in a first-in-human micro-dosing study.

On September 30, 2007, Ardea had a total of $35.6 million in cash, cash equivalents and short-term investments. Based on current projections, the Company expects cash, cash equivalents, and short-term investments on December 31, 2007 to be approximately $28 million. The Company expects its current cash resources to fund operations through 2008. These projections exclude the potential impact of any future business development or financing activity.

Approximately 11.8 million common equivalent shares were issued and outstanding on September 30, 2007, including 1.6 million common shares underlying outstanding convertible preferred stock.

About Ardea Biosciences, Inc.

Ardea Biosciences is focused on the discovery and development of small-molecule therapeutics for the treatment of viral diseases, cancer and inflammatory diseases. The Company plans to initiate clinical studies on four compounds this year. These include RDEA806, the Company's lead non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV, which recently completed Phase 1 clinical trials, RDEA119, a mitogen-activated ERK kinase (MEK) inhibitor for the treatment of cancer and inflammatory diseases, which has been cleared by the FDA to enter Phase 1 clinical trials, and a follow-on NNRTI and a follow-on MEK inhibitor, both of which are scheduled to enter first-in-human studies in the fourth quarter of 2007.

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: Ardea's goals, including its goal of initiating clinical studies on four compounds this year, the initiation of a program to evaluate RDEA119 in inflammatory diseases and its 2007 year-end cash projection. Risks that contribute to the uncertain nature of the forward-looking statements include: risks related to the outcomes of preclinical and clinical trials, risks related to regulatory approvals, delays in commencement of preclinical and clinical tests, and costs associated with internal development and in-licensing activities. These and other risks and uncertainties are described more fully in Ardea's most recently filed SEC documents, including its Annual Report on Form 10-K and 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. Ardea undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

ARDEA BIOSCIENCES, INC. (formerly IntraBiotics Pharmaceuticals, Inc) CONDENSED STATEMENTS OF OPERATIONS (In thousands, except per share amounts) (Unaudited) Three Months Ended Nine Months Ended September 30, September 30, 2007 2006 2007 2006 Sponsored Research Revenue $1,077 $- $2,827 $- Operating expenses: Research and development 7,114 - 15,843 7 General and administrative 1,785 463 4,913 1,677 Total operating expenses 8,899 463 20,756 1,684 Operating loss: (7,822) (463) (17,929) (1,684) Interest income 509 635 1,688 1,731 Other income, net 4 4 188 2 Net income (loss) (7,309) 176 (16,053) 49 Non-cash dividends on Series A preferred stock (60) (60) (180) (180) Net income/(loss) applicable to common stockholders $(7,369) $116 $(16,233) $(131) Basic net income/(loss) per share applicable to common stockholders $(0.72) $0.01 $(1.67) $(0.01) Diluted net income/(loss) per share applicable to common stockholders $(0.72) $0.01 $(1.67) $(0.01) Weighted average shares used to compute basic net income/(loss) per share applicable to common stockholders 10,182 9,334 9,716 9,316 Weighted average shares used to compute diluted net income/(loss) per share applicable to common stockholders 10,182 11,560 9,716 9,316 The accompanying notes are an integral part of these financial statements. Condensed Balance Sheet Data (In thousands) September 30, December 31, 2007 2006 Cash, cash equivalents and short-term investments $35,586 $48,669 Total assets $37,801 $50,240 Total stockholders' equity $34,620 $49,064

Ardea Biosciences, Inc.

CONTACT: Chris Krueger, Chief Business Officer of Ardea Biosciences,Inc., +1-760-602-9406

Web site: http://www.ardeabiosciences.com/

Source: PRNewswire-FirstCall

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