Oct. 29, 2009 (PR Newswire) -- SAN DIEGO, Oct. 29 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS), a biopharmaceutical company dedicated to improving patient care by developing novel medicines for the treatment of hepatitis C, today reported its financial results and program highlights for the third quarter ended September 30, 2009.
"During the third quarter, we initiated dosing HCV patients in our Phase II combination study of ANA598 and today are announcing the full enrollment of the first cohort in this study," said Steve Worland, Ph.D., President and CEO of Anadys. "We are pleased with the speed of enrollment for the first cohort and maintain our expectation to receive initial 28-day safety and response data from this cohort by year-end. Patients are scheduled to continue receiving ANA598 through 12 weeks, and we expect to receive the remaining on-treatment data from both cohorts in the study during the first half of next year."
Financial Results
As of September 30, 2009, the Company's cash, cash equivalents and securities available-for-sale totaled $25.4 million compared to $27.9 million as of December 31, 2008. The decrease in cash, cash equivalents and securities available-for-sale is the result of year-to-date cash utilization partially offset by proceeds received from a "registered direct" offering of common stock and warrants in early June 2009.
Research and development expenses were $4.0 million for the third quarter of 2009, compared to $7.6 million for the third quarter of 2008. The $3.6 million decrease was primarily attributable to a $1.8 million decrease in ANA598 development costs and a $1.5 million decrease in ANA773 development costs and to a lesser extent cost savings associated with our strategic restructuring initiated in June 2009. During the third quarter of 2008 we incurred a significant increase in development costs associated with our ANA598 program related to our then on-going Phase I healthy volunteer clinical trial, the initiation of long-term chronic toxicology studies and the manufacturing of additional drug substance to support the long-term chronic toxicology studies. ANA598 development costs during the third quarter of 2009 were primarily related to the initiation of our Phase II combination study. ANA773 development costs during the third quarter of 2008 were primarily driven by costs associated with the initiation of our Phase I clinical trial for the treatment of hepatitis C. During the third quarter of 2009, ANA773 development costs were primarily related to close-out costs associated with this trial.
General and administrative expenses were $2.0 million for the third quarter of 2009, compared to $2.1 million for the third quarter of 2008. The $0.1 million decrease primarily resulted from cost savings associated with our strategic restructuring initiated in June 2009.
Operating expenses were $6.0 million for the third quarter of 2009, compared to $9.7 million for the third quarter of 2008. Included as a component of Anadys' operating expenses were non-cash, share-based expenses of $0.6 million and $0.7 million for the third quarter of 2009 and 2008, respectively.
The net loss was $7.7 million for the third quarter of 2009, compared to a net loss of $9.3 million for the third quarter of 2008. Included in the net loss for the third quarter of 2009 is a $1.9 million loss resulting from an increase between June 30, 2009 and September 30, 2009 in the liability associated with common stock warrants issued in conjunction with our "registered direct" financing in early June 2009. Basic and diluted net loss per common share was $0.21 in the third quarter of 2009, compared to $0.32 in the third quarter of 2008. Non-cash share-based expense resulted in a $0.02 and $0.03 increase in basic and diluted net loss per share for the third quarter of 2009 and 2008, respectively.
For the nine months ended September 30, 2009, Anadys reported a net loss of $23.0 million, compared to $23.9 million for the same period last year. Basic and diluted net loss per common share was $0.71 and $0.83 for the nine months ended September 30, 2009 and 2008, respectively.
Development Program Highlights
ANA598
ANA598 is the Company's non-nucleoside HCV polymerase inhibitor currently in Phase II development.
-- Phase II Combination Study. Following FDA allowance of the study
protocol in late July, Anadys commenced dosing in the Phase II
combination study of ANA598 in early September. The first cohort in
this trial is now fully enrolled. Anadys expects to receive initial
28-day safety and viral load response data from the first cohort by
year-end and to receive the remaining on-treatment safety and response
data from both cohorts in this trial during the first two quarters of
2010. In the ongoing Phase II study, treatment-naive genotype 1
patients are to receive ANA598 or placebo in combination with Pegasys®
(peginterferon alfa-2a) and Copegus® (ribavirin, USP), a current
standard of care (SOC), for 12 weeks at dose levels of 200 mg or 400 mg
twice daily (bid), each with a loading dose of 800 mg bid on day one.
After week 12, patients are scheduled to continue to receive SOC alone.
Patients who have undetectable levels of virus at weeks 4 and 12 will be
randomized to stop all treatment at either week 24 or 48.
