SAN DIEGO, April 23 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS), a 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 first quarter ended March 31, 2009.
"We have now concluded three Phase I trials of ANA598, including a study in HCV patients that demonstrated potent antiviral activity over three days," said Steve Worland, Ph.D., Anadys' President and CEO. "Coupled with very favorable results at three months in our chronic toxicology studies and ongoing manufacturing activities, the conclusion of these Phase I clinical studies positions the program to be ready in mid-2009 for the first Phase II study of ANA598 in combination with pegylated interferon and ribavirin, a study with the potential to demonstrate the impact of ANA598 on durable clinical benefit, known as SVR, in HCV patients."
As of March 31, 2009, the Company's cash, cash equivalents and securities available-for-sale totaled $20.8 million compared to $27.9 million as of December 31, 2008.
Research and development expenses were $6.9 million for the first quarter of 2009 compared to $6.0 million for the first quarter of 2008. The $0.9 million increase primarily resulted from a $1.7 million increase in development costs for ANA598 in the first quarter of 2009 compared to the first quarter of 2008, partially offset by a decrease in our ANA773 development costs. The ANA598 development costs were associated with our completed Phase Ib clinical trial which was initiated during September 2008, our 14-day healthy volunteer study which was initiated in February 2009 and our on-going long-term chronic toxicology studies which were initiated during September 2008. Our ANA773 development costs during the three months ended March 31, 2009 were primarily driven by our on-going Phase I clinical trial for the treatment of HCV.
General and administrative expenses remained relatively consistent at approximately $2.1 million for the first quarter of 2009 and $2.0 million for the first quarter of 2008.
Operating expenses were $8.9 million for the first quarter of 2009, compared to $8.1 million for the first quarter of 2008. Included as a component of Anadys' operating expenses were non-cash, share-based expenses of $0.7 million for the first quarter of 2009 and 2008.
The net loss was $8.8 million for the first quarter of 2009, compared to a net loss of $7.4 million for the first quarter of 2008. Basic and diluted net loss per common share was $0.30 in the first quarter of 2009 compared to $0.26 in the first quarter of 2008. Non-cash share-based expense resulted in a $0.02 increase in basic and diluted net loss per share for the three months ended March 31, 2009 and 2008.
Development Program Highlights
ANA598 is an investigational oral non-nucleoside polymerase inhibitor that Anadys is developing for the treatment of chronic hepatitis C virus (HCV) infection. Three Phase I trials, including one in HCV patients, are now completed and the program remains on track to be ready in mid-2009 for Phase II studies of ANA598 in combination with current standard of care. The actual timing for the initiation of Phase II studies may depend on a number of factors, including FDA review timelines, the timing of any potential transaction around ANA598 or ANA773, available cash resources and funding activities, and the engagement of clinical sites.
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 chronic Hepatitis C and oncology.
Webcast of Conference Call
Anadys will host a conference call at 5:00 pm Eastern Daylight Time today to discuss its first quarter 2009 financial results and highlights and to provide an update on its development programs, including a review of the ANA598 antiviral data that was presented at EASL. 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 85383527. The webcast and telephone replay will be available through May 7, 2009.
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, which may not be duplicated in future cohorts at higher doses or future clinical studies of longer duration; (ii) the potential for the first Phase II study of ANA598 to demonstrate the impact of ANA598 on durable clinical benefit (SVR) in HCV patients; (iii) the expectation that ANA598 will be active in long-term studies in combination with pegylated interferon and ribavirin and the ability to dose ANA598 for up to 48 weeks in future combination studies; (iv) the ability of Anadys to transition into Phase II studies of ANA598 during 2009; (v) the ability to proceed to the 2000 mg dose level in the ANA773 HCV patient study and the potential to see viral load reduction with a favorable tolerability profile at the higher dose; and (vi) expectations regarding the evolution of the market for HCV therapies. 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 and early clinical studies 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 transactions 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 future products 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, 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.
Condensed Consolidated Financial Statements Anadys Pharmaceuticals, Inc. Condensed Consolidated Statements of Operations (In thousands except per share amounts) (Unaudited) Three Months Ended March 31, 2009 2008 Operating expenses Research and development $ 6,876 $ 6,009 General and administrative 2,055 2,045 Total operating expenses(1) 8,931 8,054 Interest income and other, net 172 610 Net loss(1) $ (8,759) $ (7,444) Net loss per share, basic and diluted(1) $ (0.30) $ (0.26) Share used in calculating net loss per share, basic and diluted 28,838 28,697
(1) Includes non-cash operating expenses of $684 and $661 determined in accordance with Statement of Financial Accounts Standards No. 123(R), "Share-Based Payment" (SFAS No. 123(R)) or approximately $0.02 and $0.02 effect on basic and diluted net loss per common share for the three months ended March 31, 2009 and 2008, respectively. Research and development expense and general and administrative expense includes $328 and $356 of non-cash operating expenses determined in accordance with SFAS No. 123(R) for the three months ended March 31, 2009. Research and development expense and general and administrative expense includes $310 and $351 of non-cash operating expenses determined in accordance with SFAS No. 123(R) for the three months ended March 31, 2008.
Anadys Pharmaceuticals, Inc. Condensed Consolidated Balance Sheets (In thousands) March 31, December 31, 2009 2008 (Unaudited) (Audited) Assets Cash, cash equivalents and securities available-for-sale $ 20,845 $ 27,936 Other current assets 2,095 2,202 Noncurrent assets 1,243 1,536 Total assets $ 24,183 $ 31,674 Liabilities and Stockholders' Equity Current liabilities $ 6,224 $ 5,813 Other long-term liabilities 34 36 Stockholders' equity 17,925 25,825 Total liabilities and stockholders' equity $ 24,183 $ 31,674
|SOURCE Anadys Pharmaceuticals, Inc.|
Copyright©2009 PR Newswire.
All rights reserved