Inhibitex, Inc. (NASDAQ:INHX) (the "Company") today announced its financial results for the second quarter ended June 30, 2010.
“Our financial results and clinical progress during the second quarter reflect our continued commitment to executing our operating and clinical development plans in an effective and disciplined manner”
"Our financial results and clinical progress during the second quarter reflect our continued commitment to executing our operating and clinical development plans in an effective and disciplined manner," stated Russell H. Plumb, President and CEO of Inhibitex, Inc. "We advanced INX-189, our HCV nucleotide polymerase inhibitor, into a first-in-man, single ascending dose study in the second quarter, and we are on track to complete this study during the third quarter. In addition, our ongoing Phase II trial of FV-100 in shingles patients is enrolling well, and with the favorable independent data safety monitoring board recommendation we received in July to continue enrollment as planned, we expect to have top-line data from the trial available in the fourth quarter."
Second Quarter Financial Results
As of June 30, 2010, the Company held $29.3 million in cash, cash equivalents and short-term investments. The Company reported a net loss in the second quarter of $5.6 million, as compared to a net loss of $4.2 million in the second quarter of 2009. Basic and diluted net loss per share was $0.09 for the second quarter of 2010 as compared to $0.10 in the second quarter of 2009. The $1.4 million increase in net loss in the second quarter of 2010 was the result of higher research and development expense, lower net interest income and a slight increase in general and administrative expense. The decrease in net loss per share for the second quarter of 2010 was the result of an increase in the number of weighted-average shares outstanding as compared to 2009, offset in part by the increase in net loss.
Research and development expense increased to $4.9 million in the second quarter of 2010 from $3.7 million in the second quarter of 2009, due principally to a $1.5 million increase in direct costs incurred in connection with the clinical development of INX-189 and to a lesser extent, the clinical development of FV-100, offset in part by a $0.3 million decrease in non-direct expenses.
Recent Corporate Developments
FV-100 for Shingles - In July 2010, the Company reported that the independent data safety monitoring board (DSMB) responsible for reviewing safety data from the Company's ongoing Phase II clinical trial of FV-100 met, as scheduled, after the Company had provided it with complete 30-day follow-up safety data on the third quartile (75%) of the patients that the Company plans to enroll in the trial. Based upon its review, the DSMB recommended that the trial continue as planned, without modification.
INX-189 for Chronic Hepatitis C - In May 2010, the Company announced that it had initiated a Phase I double-blind, placebo-controlled, single ascending dose study to evaluate the safety and pharmacokinetics of INX-189 in healthy volunteers. The study, which is being conducted in the U.S. under an Investigational New Drug application filed with the FDA, is designed to evaluate up to six escalating doses of INX-189. Each dose cohort will include eight subjects, six of which will receive INX-189 and two of which will receive placebo. The Company expects to complete this study in the third quarter of 2010 and thereafter plans to advance INX-189, subject to FDA review, into a Phase 1b multiple ascending dose clinical trial to evaluate its safety and viral kinetics in treatment naïve patients with chronic hepatitis C.