[No new info in this PR other than the financials. VRUS is well capitalized: cash as of 12/31/09 was $51.8M, and $43.5M was raised in the recent private placement (#msg-35234913); thus, the cash balance as of today is $95M less what has been burned during 2009 to date. VRUS does not hold quarterly CC’s. Please see actual PR for financial tables.]
PRINCETON, N.J., Feb. 9 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS - News), a clinical stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections, reported operational highlights and financial results for the fiscal quarter ended December 31, 2008.
Financial Results
Revenues were $0.5 million during each of the quarters ended December 31, 2008 and December 31, 2007 and reflect amortization of up-front and subsequent collaborative and license payments received from Roche.
Net cash used in operating activities was $15.3 million for the quarter ended December 31, 2008 as compared to $17.1 million for the quarter ended December 31, 2007. Pharmasset held $51.8 million in cash and cash equivalents and short term investments at the end of the fiscal first quarter.[This excludes the $43.5M raised during February.]
Total costs and expenses for the quarter ended December 31, 2008 were $18.1 million as compared to $13.2 million for the same period in 2007. The increased operating expenses for the quarter ended December 31, 2008 were primarily the result of an increase in phase 3 registration clinical trial expenses for clevudine for the treatment of chronic hepatitis B (HBV) infection, as well as increased preclinical development expenses for our second generation HCV product candidate, PSI-7851.
Pharmasset reported a net loss attributable to common stockholders of $18.3 million, or $0.78 per share for the quarter ended December 31, 2008, as compared to a net loss attributable to common stockholders of $12.2 million, or $0.57 per share for the quarter ended December 31, 2007.
Recent Highlights[as previously reported]:
-- In November 2008, Roche initiated the INFORM-1 trial, a potentially ground-breaking study to investigate the activity of a combination of two oral antiviral molecules to treat hepatitis C virus (HCV) in the absence of interferon. The study will investigate the combination of Pharmasset's R7128 with InterMune's R7227, a protease inhibitor;
-- On January 11, 2009, Pharmasset announced that the company and its development partner, Roche, had agreed with the FDA on the design for a phase 2b trial with R7128, a nucleoside inhibitor of HCV, slated to initiate in the first calendar quarter of 2009;
-- On January 30, 2009, Pharmasset filed an IND for PSI-7851, a nucleotide inhibitor of HCV, with the FDA and expects to initiate a Phase 1 clinical trial to study safety and pharmacokinetics in healthy volunteers at the end of the first calendar quarter of 2009;
-- On January 30, 2009, Pharmasset and Bukwang Pharm. Co., Ltd. entered into an amendment of their license agreement covering clevudine. The amendment expands the territories in which Pharmasset has been granted rights to include Australia, Japan, New Zealand and Taiwan;
-- On February 5, 2009, Pharmasset completed a registered direct offering that raised net proceeds of $43.5 million.
"We had a very productive start to 2009, filing an IND for PSI-7851, our second generation nucleotide for HCV and, strengthening our balance sheet by raising $43.5 million in a tough financial market" stated Schaefer Price, President and Chief Executive Officer. "Our goal remains to build a leading franchise of nucleoside inhibitors for hepatitis C and B. Our plan is to provide updates throughout the year on all of our programs, including the first antiviral data on PSI-7851 in the second half of 2009."
Calendar Year 2009 Anticipated Milestones:
-- Roche initiates phase 2b study of R7128 in first quarter of 2009;
-- Complete enrollment of clevudine registration trials at end of first quarter of 2009;
-- Initiate Phase 1 studies with PSI-7851 in the first quarter of 2009;
-- Report interim results from INFORM-1 trial in second quarter of 2009[presumably at EASL];
-- Report interim results from 28 day add-on study with R7128 in non-responder, HCV genotype 2 and genotype 3 patients in first half of 2009;
-- Report interim results from 28 day add-on study with R7128 in treatment naive, HCV genotype 1 patients in first half of 2009;
-- Report phase 1 antiviral data with PSI-7851 in second half of 2009.
About Pharmasset
Pharmasset is a clinical stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is on the development of oral therapeutics for the treatment of hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV).
Pharmasset is currently developing three product candidates. Clevudine, for the treatment of chronic HBV infection, is enrolling Phase 3 clinical trials for registration in North, Central and South America and Europe, among other countries. Clevudine is already approved for HBV in South Korea and marketed by Bukwang Pharmaceuticals in South Korea under the brand name Levovir. R7128, an oral treatment for chronic HCV infection, has completed a 4-week clinical trial in combination with Pegasys® plus Copegus® through a strategic collaboration with Roche. Racivir, which is being developed for the treatment of HIV in combination with other approved HIV drugs, has completed a Phase 2 clinical trial. Pharmasset also anticipates initiating phase 1 studies with its second generation nucleotide inhibitor for HCV, PSI-7851 in the first quarter of 2009.‹
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