SAN DIEGO, Feb. 26 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. , a clinical-stage biopharmaceutical company dedicated to improving patient care by developing novel medicines in the areas of hepatitis C and oncology, today reported its financial results and highlights for the fourth quarter and year-ended December 31, 2008.
“2008 was a very productive year at Anadys,” said Steve Worland, Ph.D., Anadys’ President and CEO. “We resumed clinical development activities and positioned our HCV programs for viral load data, which we now have begun to see. We have established ANA598 as a potent antiviral, demonstrating in three days a greater viral load decline as a single agent than has been reported for any other non-nucleoside polymerase inhibitor. And today we are reporting that we have seen preliminary indications of antiviral activity with ANA773, our oral inducer of endogenous interferons that acts via the TLR7 pathway. We believe that ANA598, and potentially ANA773, hold promise to become important parts of future combination regimens to treat HCV patients.”
Financial Results
As of December 31, 2008, the Company’s cash, cash equivalents and securities available-for-sale totaled $27.9 million.
During the fourth quarter of 2008 the Company had no revenue, compared to $0.2 million for the same quarter of 2007. The revenue in the fourth quarter of 2007 was primarily derived from the successful completion of our screening collaboration with Aphoenix, Inc.
Research and development expenses were $6.9 million for the fourth quarter of 2008 and 2007. During the fourth quarter of 2008, cost savings derived from Anadys’ completed strategic restructuring were offset by significant increases in development costs for ANA598 and ANA773.
General and administrative expenses were $2.0 million for the fourth quarter of 2008, compared to $1.8 million for the fourth quarter of 2007. The $0.2 million increase primarily resulted from an increase in facility related costs.
Operating expenses were $8.9 million for the fourth quarter of 2008, compared to $8.8 million for the fourth quarter of 2007. Included as a component of Anadys’ operating expenses were non-cash, share-based expenses of $0.7 million and $0.6 million for the fourth quarter of 2008 and 2007, respectively.
The net loss was $8.5 million for the fourth quarter of 2008, compared to a net loss of $7.8 million for the fourth quarter of 2007. Basic and diluted net loss per common share was $0.30 in the fourth quarter of 2008, compared to $0.27 in the fourth quarter of 2007. Non-cash share-based expense resulted in a $0.02 increase in basic and diluted net loss per share for the fourth quarter of 2008 and 2007.
During the twelve months ended December 31, 2008 the Company had no revenue, compared to $24.1 million for the same period in 2007. The revenue recognized in 2007 was primarily derived from the amortization of upfront and milestone payments under a prior collaboration and additionally the recognition of previously deferred revenue upon termination of the collaboration. Operating expenses during the twelve months ended December 31, 2008 were $34.1 million compared to $36.9 million for the twelve months ended December 31, 2007. The decrease in operating expenses was a result of cost savings derived from Anadys’ completed restructuring partially offset by increases in development costs for ANA598 and ANA773. For the twelve months ended December 31, 2008, Anadys reported a net loss of $32.4 million, compared to $9.2 million for the same period last year. Basic and diluted net loss per common share was $1.13 for the twelve months ended December 31, 2008, compared to $0.32 for the same period in 2007.
Development Program Highlights
ANA598
ANA598 is an investigational oral non-nucleoside polymerase inhibitor that Anadys is developing for the treatment of chronic hepatitis C virus (HCV) infection. ANA598 has recently demonstrated potent antiviral activity at the first dose level in an ongoing short-term study in HCV patients. The magnitude of viral load decline seen at the first dose level was greater than has been reported for any other non-nucleoside polymerase inhibitor in a monotherapy study. A number of clinical, toxicology and manufacturing activities are underway which, if successful in the short-term, should position ANA598 to be ready in mid-2009 for Phase II studies in combination with current standard of care. In December 2008, Anadys announced that the U.S. Food and Drug Administration granted Fast Track Designation to ANA598 as a treatment for chronic HCV infection.
ANA773
ANA773 is an oral prodrug of a small molecule inducer of endogenous interferons that acts via the toll-like receptor 7 (TLR7) pathway. Anadys has completed 3-month toxicology and pharmacology studies in animals that demonstrated stable induction of interferon-dependent pathways at doses that led to no adverse findings. Anadys is exploring ANA773 in two early clinical studies, one in HCV patients that is being conducted in the Netherlands and one in oncology patients that is being conducted in the United States.
Webcast of Conference Call
Anadys will host a conference call at 5:00 p.m. EST today to discuss its fourth quarter and year-end financial results and highlights and to provide an update on its development programs. 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 93047283. The webcast and telephone replay will be available through March 5, 2009.
About Anadys
Anadys Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company dedicated to improving patient care by developing novel medicines in the areas of hepatitis C and oncology. For the treatment of chronic hepatitis C, the Company is developing two potentially complementary agents, ANA598, a non-nucleoside polymerase inhibitor and ANA773, an oral inducer of endogenous interferons that acts via the TLR7 pathway. The Company is also developing ANA773 for the treatment of cancer.
Safe Harbor Statement
Statements in this press release that are not strictly historical in nature constitute “forward-looking statements.” Such statements include, but are not limited to, references to (i) the potency, safety and tolerability profile of ANA598 seen to date, which may not be duplicated in future cohorts at higher doses or future clinical studies of longer duration; (ii) the preliminary indications of antiviral activity with ANA773 and next steps for the program; (iii) the potential for ANA598 and ANA773 to become important parts of future combination regimens to treat HCV patients; (iv) the ability of ANA598 to be ready for Phase II studies in mid-2009; and (v) expectations regarding the timing of receiving data. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause Anadys’ actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. For example, the results of preclinical studies and early clinical trials may not be predictive of future results, and Anadys cannot provide any assurances that ANA598 or ANA773 will not have unforeseen safety issues, will have favorable results in ongoing or future clinical trials or will receive regulatory approval. In addition, Anadys’ results may be affected by competition from other biotechnology and pharmaceutical companies, its effectiveness at managing its financial resources, its ability to enter into collaborations around its product candidates, its ability to successfully develop and market products, difficulties or delays in its preclinical studies or clinical trials, difficulties or delays in manufacturing its clinical trials materials, the scope and validity of patent protection for its products, regulatory developments involving its product candidates and its ability to obtain additional funding to support its operations. Risk factors that may cause actual results to differ are more fully discussed in Anadys’ SEC filings, including Anadys’ Form 10-K for the year ended December 31, 2007 and Anadys’ Form 10-Q for the quarter ended September 30, 2008. All forward-looking statements are qualified in their entirety by this cautionary statement. Anadys is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
CONTACT: Investor, James T. Glover, SVP, Operations & CFO of Anadys
Pharmaceuticals, Inc., +1-858-530-3763, jglover@anadyspharma.com; or Media,
Ian Stone, ian.stone@russopartnersllc.com or David Schull,
david.schull@russopartnersllc.com, both of Russo Partners, LLC,
+1-619-528-2220, for Anadys Pharmaceuticals, Inc.
Web site: http://www.anadyspharma.com/
