Inhibitex, Inc. (Nasdaq: INHX), today announced its financial results for the third quarter ended September 30, 2009. The Company held cash, cash equivalents and short-term investments of $21.1 million at September 30, 2009, as compared to $33.1 million at December 31, 2008.
“We continue to make progress on all fronts, including the advancement of our differentiated antiviral development programs and most recently, the completion of a financing that we believe strategically positions us to develop both FV-100 and INX-189 through their respective clinical proof of concept trials,” stated Russell H. Plumb, President and CEO of Inhibitex, Inc. “We continue to anticipate completing our Phase II clinical trial of FV-100 in shingles patients around the middle of next year, and subject to the successful completion of ongoing GLP studies, believe we are on track to file an investigational new drug application and initiate a Phase I clinical trial of INX-189 in the first half of 2010.”
Third Quarter 2009 Financial Results
The Company reported a net loss for the third quarter of 2009 of $4.5 million, as compared to a net loss of $4.0 million in the third quarter of last year. Basic and diluted net loss per share was $0.10 for the third quarter of 2009 as compared to basic and diluted net loss per share of $0.09 per share in the third quarter of 2008. The increase in net loss and net loss per share in the third quarter of 2009 was the result of higher research and development expense, lower revenues from collaborative license and development agreements and lower net interest income, offset in part by a reduction in general and administrative expense.
Revenue decreased to $0.3 million in the third quarter of 2009 from $0.8 million in the third quarter of 2008. The $0.5 million decrease was primarily the result of 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 $3.9 million in the third quarter of 2009 from $3.5 million in the third quarter of 2008, primarily due to a $0.5 million increase in direct costs incurred in connection with the clinical development of FV-100 and the preclinical development of INX-189, offset in part by a $0.1 million decrease in other non-direct expenses.
General and administrative expense decreased to $0.8 million in the third quarter of 2009 from $1.5 million in the third quarter of 2008. This $0.7 million decrease consisted of a $0.3 million reduction in depreciation and facility-related expenses due to a loss on rent accrual in 2008 and a $0.4 million decrease in other expenses.
The Company updated its financial guidance in light of its recent financing, the clinical status of FV-100 and its preclinical and clinical development plans for INX-189. The Company currently anticipates that it will have between $36-$37 million in cash, cash equivalents and short-term investments on hand at the end of 2009, and that it has sufficient financial resources to support its planned operations through the end of 2011.
Financial guidance involves a high level of uncertainty and is subject to numerous assumptions and factors. These factors include, but are not limited to: the funding requirements and time it may take to conduct preclinical research, formulate and manufacture clinical trial materials and conduct clinical trials; the ability to enroll subjects or patients in clinical trials on a timely basis, if at all, and whether the results of these clinical trials are favorable; receiving regulatory approvals on a timely basis to proceed with the clinical development of a drug candidate; the cost of filing, prosecuting and enforcing patents or other intellectual property rights; changes in the Company’s strategy or development plans in the future; and the level of general and administrative expenses needed to support the Company’s business strategy and its publicly-traded status. In addition, the financial guidance does not consider or reflect the potential financial or operating impact of any additional alliances, licensing or collaboration agreements, or other similar transactions that may occur in the future.
Recent Corporate Developments
FV-100 - The Company has approximately 60 sites initiated and qualified to enroll patients in its Phase II clinical trial to evaluate the safety and biologic activity of FV-100 for the treatment of shingles.
INX -189 –During the third quarter, the Company advanced INX-189, its lead HCV protide polymerase inhibitor, into Good Laboratory Practice (GLP) studies based upon the results of extensive preclinical in vitro and in vivo studies.
NASDAQ Listing Transfer – In October 2009, the Company received written notification from The Nasdaq Stock Market (“Nasdaq”) stating that the closing bid price of the Company’s common stock had been at or above $1.00 per share for 10 consecutive business days, and therefore the Company had regained compliance with Nasdaq’s Listing Rule 5550(a)(2) and its delisting matter has been closed.
Private Placement Financing – In October, the Company completed a private placement of common stock and warrants to a group of new and existing institutional investors, raising gross proceeds of approximately $23 million. In connection with the private placement, the Company is required to file a registration statement on Form S-3 with the Securities and Exchange Commission to register the resale of shares of common stock and the shares of common stock issuable upon the exercise of the warrants issued pursuant to the financing.
Presentation at AASLD Meeting – Earlier this week, the Company presented preclinical pharmacokinetic data on INX-189 in a poster at the 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston, MA. A copy of the poster presentation is available on the Company’s website at www.inhibitex.com.
Conference Call and Webcast Information
Russell H. Plumb, president and chief executive officer of Inhibitex, and other members of management will review the Company’s third quarter 2009 operating results and financial position, as well as provide a general update on the Company via a webcast and conference call today at 9:00 a.m. EDT. To access the conference call, please dial (877) 407-8033 (domestic) or (201) 689-8033 (international). A replay of the call will be available from 11:00 a.m. EDT on November 6 until December 6, 2009 at midnight. To access the replay, please dial (877) 660-6853 (domestic) or (201) 612-7415 (international) and reference the account # 286 and the conference id # 336098. A live audio webcast of the call and the archived webcast will be available under the News and Events category on the Inhibitex website at http://www.inhibitex.com.