SAN DIEGO, Aug. 8, 2011 /PRNewswire/ -- 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 program highlights and financial results for the second quarter ended June 30, 2011.
Development Program Highlights
- Enrollment is complete in the Phase IIb study of setrobuvir (ANA598), in which setrobuvir is being tested in combination with pegylated interferon and ribavirin in hepatitis C patients. All patients are scheduled to complete their 12 week visit by the end of the third quarter of 2011 and the Company expects to release preliminary 12 week data shortly thereafter. Antiviral response data through 24 weeks are expected around year-end. Anadys also entered into its first cross-company clinical trial agreement to study setrobuvir in combination with another direct-acting antiviral (DAA) in healthy volunteers.
- Anadys was granted U.S. Patent No. 7,939,524, which recognizes the Company’s intellectual property rights to the composition of matter and methods of use for setrobuvir and related compounds.
- Anadys is finalizing preparations for a Phase IIa study of ANA773 in combination with ribavirin in HCV patients, which it expects to initiate in Europe during the third quarter of 2011. The Company expects to complete dosing in the first cohort in this study during the fourth quarter of 2011. Phase I clinical data for ANA773 from a previously completed cancer study was presented in June at the 2011 American Society of Clinical Oncology (ASCO) Annual Meeting. In this study, ANA773 showed a favorable safety and tolerability profile at doses that had desired effects on the innate immune system.
“Having completed enrollment in the Phase IIb study of setrobuvir with interferon and ribavirin, we have now turned our focus to the implementation of combination studies of setrobuvir with other DAAs,” said Steve Worland, Ph.D., President and CEO of Anadys. “In addition to the first agreement entered into this past quarter, we are currently taking steps to pursue additional DAA combination studies with setrobuvir in the near-term.”
Financial Results and Highlights
As of June 30, 2011, Anadys’ cash, cash equivalents and securities available-for-sale totaled $25.8 million compared to $38.0 million as of December 31, 2010. The decrease in cash, cash equivalents and securities available-for-sale is the result of cash utilization to fund operations during the first six months of 2011.
Total operating expenses were $8.5 million for the second quarter of 2011, compared to $4.7 million for the second quarter of 2010. Included as a component of Anadys’ operating expenses were non-cash, share-based expense of $0.4 million for the second quarter of 2011 and 2010.
Research and development expenses were $7.0 million for the second quarter of 2011, compared to $3.1 million for the second quarter of 2010. The $3.9 million increase was primarily attributable to a $3.5 million increase in setrobuvir (ANA598) development costs and a $0.7 million increase in ANA773 development costs.
General and administrative expenses were relatively consistent at $1.5 million for the second quarter of 2011 compared to $1.6 million for second quarter of 2010.
The net loss was $8.1 million for the second quarter of 2011, compared to a net loss of $3.0 million for the second quarter of 2010. Included as a component of net loss were non-cash gains of $0.4 million and $1.6 million for the second quarter of 2011 and 2010, respectively, resulting from a decrease in the liability associated with our common stock warrants. The warrants were issued in connection with a “registered direct” offering in June 2009. Basic and diluted net loss per common share was $0.14 in the second quarter of 2011, compared to $0.08 in the second quarter of 2010. Non-cash share-based expense resulted in a $0.01 increase in basic and diluted net loss per share for the second quarter of 2011 and 2010.
For the six months ended June 30, 2011, Anadys reported a net loss of $14.1 million, compared to $9.2 million for the same period last year. Basic and diluted net loss per common share were $0.25 for the six months ended June 30, 2011 compared to $0.24 for the same period last year.
Conference Call Webcast
Anadys will host a conference call and webcast at 5:00 pm Eastern Daylight Time today to discuss its second quarter 2011 financial results and highlights. A live webcast of the call will be available online at www.anadyspharma.com. A telephone replay will also be available approximately one hour after completion of the call. To access the telephone replay, dial 888-286-8010 (domestic) or 617-801-6888 (international), passcode 39592231. The webcast and telephone replay will be available through August 22, 2011.
