SAN DIEGO, Aug. 14 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. , a company focused on the discovery and development of small-molecule therapeutics for the treatment of human immunodeficiency virus (HIV), gout, cancer and inflammatory diseases today reported recent accomplishments and financial results for the three and six months ended June 30, 2008.
"We made significant progress during the second quarter, reporting promising preclinical and clinical data from all of our programs, including the final results of our Phase 2a study with RDEA806, our lead non-nucleoside reverse transcriptase inhibitor (NNRTI) in HIV patients, and preclinical data demonstrating the mechanism by which RDEA594, our lead product candidate for the treatment of gout patients, lowers serum uric acid levels. We also initiated a Phase 2a proof-of-concept study of RDEA806, a prodrug of RDEA594, which should allow us to provide an early confirmation of RDEA594's activity in the target population of gout patients. Finally, we strengthened our management team, board of directors and scientific advisory board through key appointments," said Barry D. Quart, PharmD, Ardea Biosciences' President and CEO.
"The second half of the year should be equally productive as we plan to initiate a Phase 2b clinical study with RDEA806 in HIV patients and a Phase 1 study of RDEA594 in normal healthy volunteers. We also plan to progress our 2nd generation NNRTI and MEK inhibitors into Phase 1 clinical studies by the end of the year," added Dr. Quart.
Additionally, we announced the appointment of Craig A. Johnson to our Board of Directors and John W. Beck as Senior Vice President, Finance and Operations and Chief Financial Officer and the expansion of our inflammatory disease Scientific Advisory Board with the addition of international gout specialist, Dr. Fernando Perez-Ruiz.
Upcoming Clinical Development Milestones
We expect to achieve the following significant milestones before the end of the year:
Second Quarter and Year-to-Date 2008 Financial Results
As of June 30, 2008, we had $42.7 million in cash, cash equivalents and short-term investments, compared to $66.2 million as of December 31, 2007. The $23.5 million decrease in cash, cash equivalents and short-term investments during the first half of 2008 was due to the use of cash to fund our preclinical and clinical programs, increased personnel costs and for other general corporate purposes, including our facility relocation.
The net loss applicable to common stockholders for the three and six months ended June 30, 2008 was $15.7 million and $28.2 million, or $1.10 per share and $2.03 per share, respectively, compared to a net loss applicable to common stockholders for the same periods in 2007 of $5.4 million and $8.9 million, or $0.57 per share and $0.94 per share, respectively. The net loss applicable to common stockholders for the three and six months ended June 30, 2008 included non-cash charges of $1.3 million and $2.4 million, or $0.09 per share and $0.17 per share, respectively, for stock-based compensation expense. For the same periods in 2007, we reported non-cash charges of $0.2 million and $0.4 million, or $ 0.02 per share and $0.04 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 primarily due to increased research and development expenses related to the continued development and progression of our preclinical and clinical product candidates and increased general and administrative expenses to support that effort and our overall growth.
Revenue for the six months ended June 30, 2008 was $0.3 million, compared to $0.9 million and $1.8 million for the three and six months ended June 30, 2007, respectively. There were no revenues for the three months ended June 30, 2008. Historically, our revenues have resulted from the research services we provide under our master services agreement with Valeant Research and Development, Inc. (Valeant) for their preclinical neuropharmacology program. 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.
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 HIV, gout, cancer and inflammatory diseases. We have four 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 2nd generation NNRTI for the treatment of HIV, RDEA427, in a human micro-dose pharmacokinetic study and have selected it for clinical development. RDEA594, our lead product candidate for the treatment of gout, is in preclinical development. We are also seeking to provide an early confirmation of RDEA594's activity in gout patients with hyperuricemia in a Phase 2a study using its prodrug, RDEA806. We are evaluating our lead MEK inhibitor, RDEA119, in a Phase 1 study in advanced cancer patients, and have completed a Phase 1 study of RDEA119 in normal healthy volunteers as a precursor to trials in patients with inflammatory diseases. Lastly, we have evaluated our 2nd 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, RDEA427, RDEA594, RDEA119, RDEA436 and our other compounds, the timing and results of our preclinical, clinical and other studies 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, and costs associated with our drug discovery and development programs and 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.
CONTACT: Investors, John Beck of Ardea Biosciences, +1-858-652-6523,
jbeck@ardeabio.com; or Media, Edie DeVine of WeissComm Partners,
+1-415-946-1081, edevine@wcpglobal.com, for Ardea Biosciences
