Ardea Biosciences Reports Recent Accomplishments and Announces Third Quarter and Year-to-Date 2009 Financial Results
Press Release
Source: Ardea Biosciences, Inc.
On 8:00 am EST, Friday November 6, 2009
Companies:Ardea Biosciences, Inc.
SAN DIEGO, Nov. 6 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA - News), a biotechnology company focused on the development of small-molecule therapeutics for the treatment of gout, cancer and human immunodeficiency virus (HIV), today reported recent accomplishments and financial results for the third quarter and nine months ended September 30, 2009.
"Since our last quarterly update, we have confirmed the activity of RDEA594 in gout patients, and we have initiated the four planned studies in our broad-based Phase 2 development program," commented Barry D. Quart, PharmD, Ardea's president and chief executive officer. "The Phase 2a results demonstrate the ability of RDEA594 to normalize renal excretion of uric acid in patients that have gout due to their inability to excrete sufficient amounts of uric acid. These under-excretors of uric acid make up approximately 90% of the patients with hyperuricemia and gout, and are the primary target population for RDEA594," added Dr. Quart.
Recent Accomplishments
On October 19, 2009, we presented at the 2009 American College of Rheumatology (ACR) / Association of Rheumatology Health Professionals (ARHP) Annual Scientific Meeting in Philadelphia, Pennsylvania, additional data from the first cohort of an ongoing Phase 2a proof-of-concept study of RDEA594, our lead product candidate in development for the treatment of hyperuricemia and gout. Important highlights from this study were:
All patients receiving RDEA594 experienced a dose-related reduction in serum uric acid levels and a majority achieved a reduction in serum urate to levels less than 6 mg/dL.
60% (6/10) of patients in this group who excrete less than normal amounts of uric acid in their urine responded to therapy by achieving a reduction in serum urate to levels less than 6 mg/dL after two weeks of treatment.
RDEA594 also produced significant reductions in serum urate in patients with mild to moderate renal impairment, with 83% (5/6) of these patients responding after two weeks of treatment. Gout patients with mild to moderate renal impairment represent a substantial portion of the gout patient population and are often not effectively treated with allopurinol.
RDEA594 was also well tolerated in this study, with no serious adverse events and no premature discontinuations due to adverse events in patients receiving RDEA594.
Ardea also presented at the ACR/ARHP meeting data from preclinical drug-drug interaction studies demonstrating RDEA594's potential to be used in combination with allopurinol and febuxostat (Uloric®, Takeda Pharmaceutical Company Limited; Adenuric®, Ipsen) and an update from a 3- and 6-month assessment of chronic toxicity in rats and monkeys, respectively, showing no organ toxicity at doses up to 300 mg/kg/day.
Clinical Development Efforts and Important Upcoming Clinical Development Milestones
All studies in our RDEA594 Phase 2 clinical development program have been initiated. These studies include a Phase 2b single-agent dose-response study evaluating the safety and urate-lowering effects of 200, 400 and 600 mg of RDEA594 in 140 gout patients (RDEA594-202), a Phase 2b combination study evaluating RDEA594 as an add-on to allopurinol in approximately 100 patients who do not respond adequately to allopurinol alone (RDEA594-203), a drug-drug interaction study with febuxostat in healthy volunteers (RDEA594-105), and a study in gout patients with renal impairment (RDEA594-204).
We expect to provide results from the second cohort of our ongoing Phase 2a proof-of-concept study evaluating RDEA594 in combination with allopurinol and Study RDEA594-105, along with an update on progress in RDEA594-204, in December 2009. We expect RDEA594-202 to complete enrollment in 2009, with results anticipated in the first quarter of 2010. We also expect to report results from RDEA594-203 in the first quarter of 2010.
In coordination with our commercial partner, Bayer HealthCare AG (Bayer), we continue to progress our ongoing Phase 1/2 study of RDEA119 in combination with sorafenib (Nexavar®, Bayer and Onyx Pharmaceuticals) and our ongoing Phase 1 monotherapy study of RDEA119 in advanced cancer patients.
Third Quarter and Year-to-Date 2009 Financial Results
As of September 30, 2009, we had $59.6 million in cash, cash equivalents, and short-term investments, and $1.4 million in receivables, compared to $57.7 million in cash, cash equivalents, and short-term investments, and $0.4 million in receivables as of December 31, 2008. The increase in cash, cash equivalents and short-term investments and receivables for the first nine months of 2009 was primarily due to the receipt of a $35.0 million non-refundable, upfront license fee and the expected reimbursement of third-party development costs associated with our MEK inhibitor program under our license agreement with Bayer, offset by the use of cash to fund our clinical-stage programs, personnel costs and for other general corporate purposes.
We anticipate that our existing cash, cash equivalents, and short-term investments will be sufficient to fund our operating activities through the first quarter of 2011. This current financial projection includes forecasted expenses associated with the RDEA594 Phase 2 and Phase 3 programs anticipated for that period, combined with expense reductions from our recent restructuring. This projection does not include any milestone payments under our license agreement with Bayer, proceeds from future partnering activities or financings, or potential payments under our asset purchase agreement with Valeant.
Revenues totaled $9.2 million and $14.7 million for the three and nine months ended September 30, 2009, respectively. There were no revenues for the three months ended September 30, 2008 and revenues totaled $0.3 million for the nine-month period ended September 30, 2008. The revenues earned during the first nine months of 2009 resulted from the recognition of a portion of the upfront, non-refundable license fee and reimbursement of third-party development costs under our license agreement with Bayer. The $35.0 million upfront license fee is being recognized on a straight-line basis over a period of approximately 13 months, which is the anticipated timeframe in which the Company expects to complete all of its obligations under the license agreement. The revenue earned in fiscal 2008 resulted from the research services we provided under our master services agreement with Valeant, which has since terminated by its terms.
The net loss applicable to common stockholders for the three and nine months ended September 30, 2009 was $2.5 million and $24.5 million, or $0.13 per share and $1.36 per share, respectively, compared to a net loss applicable to common stockholders for the same periods in 2008 of $14.2 million and $42.4 million, or $0.95 per share and $2.98 per share, respectively. The net loss applicable to common stockholders for the three and nine months ended September 30, 2009 included non-cash charges of $1.3 million and $4.3 million, or $0.07 per share and $0.24 per share, respectively, for stock-based compensation expense. For the same period in 2008, we reported non-cash charges of $1.3 million and $3.7 million, or $0.09 per share and $0.26 per share, respectively, for stock-based compensation expense.
The decrease in net loss applicable to common stockholders between these periods was primarily a result of the increase in revenues noted above for the same period, and a decrease in operating expenses, mainly due to reduced discovery research and clinical development expenditures as we continue to focus our resources on our gout-related programs, RDEA594 and RDEA684. In addition, during the third quarter of 2009, we realized savings from our restructuring plan of approximately $1.1 million. These decreases were partially offset by severance-related restructuring charges of approximately $0.1 million and $0.8 million for the three and nine months ended September 30, 2009, respectively, an increase in interest expense in connection with our growth capital loan and capital lease obligations entered into in the second half of 2008 and a decline in interest income due to lower average interest rates as compared to 2008.
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