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05/13/09 - Inhibitex Reports First Quarter 2009 Financial Results
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ATLANTA, GA - Inhibitex, Inc. (Nasdaq: INHX), announced its financial results for the first quarter ended March 31, 2009. The Company held cash, cash equivalents and short-term investments of $29.2 million at March 31, 2009, as compared to $33.1 million at December 31, 2008.
First Quarter 2009 Financial Results
The Company reported a net loss for the first quarter of 2009 of $4.2 million, as compared to a net loss of $3.5 million in the first quarter of last year. Basic and diluted net loss per share was $0.10 for the first quarter of 2009 as compared to basic and diluted net loss per share of $0.08 per share for the first quarter of 2008. The increase in net loss and net loss per share in the first quarter of 2009 was the result of lower revenues from collaborative license and development agreements, lower net interest income and higher research and development expense, offset by a reduction in general and administrative expense.
Revenue for the first quarter of 2009 was $0.3 million as compared to $0.8 million in the first quarter of 2008. The $0.5 million decrease in revenue was primarily the result of certain upfront license fees received by the Company in 2007 and 2008 being fully amortized to revenue as of the end of 2008, and to a lesser extent, lower periodic research-associated support fees received by the Company.
Research and development expense increased to $3.5 million in the first quarter of 2009 from $3.4 million in the first quarter of 2008. The increase of $0.1 million was primarily the result of an increase of $0.3 million in direct costs incurred in connection with the clinical development of FV-100 and the Company’s HCV preclinical development program, offset by a $0.2 million decrease in salaries, benefits and share-based compensation.
General and administrative expense decreased to $1.1 million in the first quarter of 2009 from $1.3 million in the first quarter of 2008. This decrease of $0.2 million was primarily related to a decrease in salaries, benefits and share-based compensation.
The Company recorded non-cash, share-based compensation expense of $0.2 million in the first quarter of 2009, of which $0.1 million was recorded as research and development expense and $0.1 million as general and administrative expense.
For the quarter ended March 31, 2009, net interest income decreased to $0.1 million from $0.5 million in the first quarter of 2008 as a result of lower interest rates and lower cash and investment balances.
Recent Corporate Developments
FV-100 – On May 8, 2009 the Company reported it had initiated a Phase II clinical trial of FV-100, its highly potent compound in development for the treatment of herpes zoster (shingles). The Phase II clinical trial is a well-controlled, double-blind randomized study comparing two different once-a-day doses of FV-100 to an active control (valacyclovir). The Company anticipates enrolling approximately 350 patients in the trial, who will be equally randomized to one of the three treatment arms. In addition to further evaluating its safety, the objectives of the trial include: evaluating the therapeutic benefit of FV-100 in reducing the severity and duration of acute shingles-related pain; the incidence of post herpetic neuralgia (PHN); the time to lesion healing; and the use of concomitant pain medications.
In February 2009, the Company reported that it had completed its Phase I clinical trials of FV-100. The trials included both a single and multiple ascending dose study in subjects aged 18-55, as well as a separate study conducted in subjects 65 years of age or older. The Company reported that in all three trials there were no serious adverse events reported, and FV-100 appeared to be well tolerated at all dose levels. Additionally, pharmacokinetic data demonstrated that all doses of FV-100 maintained mean plasma levels of its active form that support the evaluation of once-a-day dosing in Phase II. The Company recently presented data from its Phase I studies at the 22nd Annual International Conference on Antiviral Research (ICAR).
HCV Nucleoside Polymerase Inhibitors - The Company has selected a lead compound, INX-189, from its series of proprietary HCV nucleoside polymerase inhibitors for further evaluation in IND-enabling preclinical studies. The Company presented preclinical data from its HCV program at the 44th Annual Meeting of the European Association for the Study of the Liver (EASL) in April and at ICAR earlier this month.
NASDAQ Listing Transfer – On March 24, 2009, the Company received written notification that NASDAQ had suspended enforcement of its minimum bid price and market valuation requirement for all listed companies until July 20, 2009, and that based upon NASDAQ’s decision, the Company has until October 12, 2009 to regain compliance with NASDAQ's minimum bid price requirement.
About Shingles and FV-100: Shingles, also known as herpes zoster, is an infection caused by the reactivation of varicella zoster virus (VZV), the same virus that causes chicken pox. Worldwide, it is estimated that there are more than 2.5 million new cases of shingles each year. Shingles is generally characterized by skin lesions, acute infection-related pain, and in many cases, post herpetic neuralgia (PHN), a painful and sometimes debilitating condition that can last for months or possibly more than a year. While shingles can develop in adolescents or adults of any age, it occurs predominantly in those 40 years of age and older.
About HCV: Hepatitis C is a disease of the liver caused by the hepatitis C virus (HCV). It is estimated that approximately 4 million Americans and 170 million individuals worldwide are infected with HCV. HCV can cause chronic liver disease, cirrhosis and cancer, and is the leading cause of liver transplant in the United States. Inhibitex is developing a series of phosphoramidate nucleoside analogues, or protides, which target the RNA-dependent RNA polymerase (NS5b) of HCV. The Company believes that its protides possess several pharmacological advantages over nucleosides alone, including a significant increase in antiviral activity, higher concentrations of the triphosphate in liver, and potentially less toxicity due to reduced systemic exposure.
About Inhibitex: Inhibitex, Inc., headquartered in Alpharetta, Georgia, is a biopharmaceutical company focused on developing products to treat serious infectious diseases. In addition to FV-100, its clinical-stage product candidate, the Company’s preclinical pipeline includes a series of HCV nucleoside polymerase and HIV integrase inhibitors. Inhibitex has also licensed the use of its proprietary MSCRAMM® protein technology to Wyeth for the development of staphylococcal vaccines. For additional information about the Company, please visit www.inhibitex.com.
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