Inhibitex reports net loss of $4.8M for first-quarter 2010

May 14 2010

Inhibitex, Inc. (NASDAQ:INHX) today announced its financial results for the first quarter ended March 31, 2010. The Company also announced that it has initiated a Phase I single ascending dose trial of INX-189, its lead HCV nucleotide polymerase inhibitor, in healthy volunteers under an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA).

“We are pleased with the progress made with both of our internally-driven antiviral development programs over the past quarter”

"We are pleased with the progress made with both of our internally-driven antiviral development programs over the past quarter," stated Russell H. Plumb, President and CEO of Inhibitex, Inc. "Our IND for INX-189 is now in effect and we have initiated a first-in-man study to evaluate its safety and pharmacokinetics. We have also completed two-thirds of the planned enrollment in our ongoing Phase II trial of FV-100, and continue to anticipate that top-line data from the completed trial will be available in the fourth quarter of 2010."

First Quarter Financial Results

As of March 31, 2010, the Company held $34.1 million in cash, cash equivalents and short-term investments. The Company had a net loss in the first quarter of $4.8 million, as compared to a net loss of $4.2 million in the first quarter of 2009. Basic and diluted net loss per share was $0.08 for the first quarter of 2010 as compared to $0.10 in the first quarter of 2009. The increase in net loss in the first quarter of 2010 was the result of higher research and development expense and lower net interest income, offset in part by higher revenues from a collaborative license and development agreement and a slight reduction in general and administrative expense. The decrease in net loss per share for the first quarter of 2010 was the result of an increase in the number of weighted-average shares outstanding as compared to 2009.

Revenue increased to $1.0 million in the first quarter of 2010 from $0.3 million in the first quarter of 2009. The $0.7 million increase was primarily the result of a milestone payment earned by the Company in January 2010.

Research and development expense increased to $4.8 million in the first quarter of 2010 from $3.5 million in the first quarter of 2009, due to a $1.4 million increase in direct costs primarily incurred in connection with the preclinical development of INX-189 and to a lesser extent, the clinical development of FV-100, offset in part by a $0.1 million decrease in non-direct expenses.

General and administrative expense decreased to $1.0 million in the first quarter of 2010 from $1.1 million in the first quarter of 2009. The decrease of $0.1 million was primarily the result of a reduction in various recurring corporate expenses.

Recent Corporate Developments

FV-100 - In April 2010, the independent Data Safety Monitoring Board (DSMB) responsible for reviewing data from the Company's ongoing Phase II clinical trial of FV-100 met, as scheduled, after the Company had provided it with 30-day follow-up safety data on the first half of the patients that the Company plans to enroll in the trial. Based upon its review, the DSMB unanimously recommended that the trial should continue, as originally designed, without modification. The Company also reported that a prospectively described interim analysis of the primary efficacy endpoint was conducted by an independent statistician on the first half of the patients to be enrolled in the trial, and, as expected, the statistician recommended that the trial continue to completion as designed.

INX-189 - The Company announced that it has initiated a Phase I double-blind, placebo-controlled, single ascending dose study to evaluate the safety and pharmacokinetics of INX-189 in healthy volunteers under an IND that was filed earlier this year with the FDA. The study, which is being conducted in the U.S., will evaluate up to six escalating doses of INX-189, ranging from 3 mg up to 200 mg. Each dose cohort will include eight subjects, six of which will receive INX-189 and two that will receive placebo.

Staphylococcal Vaccine - In January 2010, the Company announced that its licensee and collaborator, Pfizer, Inc., had initiated recruitment for a randomized, double-blind Phase I clinical trial to evaluate the safety, tolerability, and immunogenicity of three ascending dose levels of a 3-antigen Staphylococcus aureus (S. aureus) vaccine (SA3Ag) in 408 healthy adults. The vaccine contains an antigen originating from the Company's proprietary MSCRAMM^® protein platform. Pfizer is responsible for all clinical development, manufacturing and marketing of the vaccine. In January, the Company earned a payment of $0.7 million upon the achievement of this milestone and is eligible to receive future regulatory milestones, as well as royalties on any future net sales.