Inhibitex Reports Second Quarter 2007 Financial Results.Completion of FermaVir Acquisition Expected in September Preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. FV-100 Data Supports Advancement into Clinical Trials ATLANTA -- Inhibitex, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :INHX) today announced its financial results for the second quarter ended June 30, 2007. The Company reported that it held $56.6 million in cash, cash equivalents and short-term investments as of June 30, 2007, as compared to $61.4 million at December 31, 2006. The Company also reported that FermaVir Pharmaceuticals recently announced favorable fa·vor·a·ble adj. 1. Advantageous; helpful: favorable winds. 2. Encouraging; propitious: a favorable diagnosis. 3. data from its preclinical studies preclinical studies, n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. of FV-100, a potent, orally bioavailable bicyclic bi·cy·clic also bi·cy·cli·cal adj. 1. Consisting of or having two cycles. 2. Botany Composed of or arranged in two distinct whorls, as the petals of a flower. 3. nucleoside analogue nucleoside analogue n. Any of a group of antiviral drugs that inhibit the viral enzyme reverse transcriptase and are used in the treatment of HIV infection. being developed for the treatment of shingles shingles: see herpes zoster. shingles or herpes zoster Acute viral skin and nerve infection. Groups of small blisters appear along certain nerve segments, most often on the back, sometimes after a dull ache at the site; pain becomes , which supports the initiation of a clinical development program for FV-100. Inhibitex previously announced in April that it has entered into a definitive merger agreement to acquire FermaVir. Pending the completion of this acquisition and subject to U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) review, Inhibitex anticipates advancing FV-100 into a single ascending ascending /as·cend·ing/ (ah-send´ing) having an upward course. ascending progressing to higher levels, usually used in reference to the nervous system. dose trial in healthy volunteers during the fourth quarter of 2007. "During the second quarter we made considerable progress in our strategy to build a pipeline of high-value antivirals and capitalize on Cap´i`tal`ize on` v. t. 1. To turn (an opportunity) to one's advantage; to take advantage of (a situation); to profit from; as, to capitalize on an opponent's mistakes s>. the potential of our MSCRAMM MSCRAMM Microbial Surface Components Recognizing Adhesive Matrix Molecules platform, setting the stage for what we anticipate will be a dynamic second half of the year," stated Russell H. Plumb, president and chief executive officer of Inhibitex. "We are on track to close the acquisition of FermaVir in September, and based on the recent preclinical data for FV-100, we believe the compound can enter clinical development in the fourth quarter. Furthermore, we anticipate making a decision on a lead candidate from FermaVir's series of cytomegalovirus cytomegalovirus (sī'təmĕg'əlōvī`rəs), member of the herpesvirus family that can cause serious complications in persons with weakened immune systems. (CMV CMV cytomegalovirus. CMV abbr. 1. controlled mechanical ventilation 2. cytomegalovirus Cytomegalovirus (CMV) ) compounds by year-end. We have also been particularly active on the business development front, and based on the status of our multiple discussions, we believe that over the next six months we will be able to achieve our goals of in-licensing one or more additional antiviral antiviral /an·ti·vi·ral/ (-vi´ral) destroying viruses or suppressing their replication, or an agent that so acts. an·ti·vi·ral adj. compounds to expand our emerging antiviral pipeline and enter into a collaboration or otherwise determine a pathway to support the advancement of Aurexis into a well-powered, Phase II proof-of-concept trial." Second Quarter 2007 Financial Results The Company reported a net loss for the second quarter of 2007 of $2.3 million, as compared to $7.7 million for the second quarter of last year. For the six months ended June 30, 2007, net loss was $1.9 million, as compared to $16.7 million for the same period in 2006. Basic and diluted di·lute tr.v. di·lut·ed, di·lut·ing, di·lutes 1. To make thinner or less concentrated by adding a liquid such as water. 2. To lessen the force, strength, purity, or brilliance of, especially by admixture. net loss per share was $0.08 for the second quarter of 2007 as compared to $0.25 per share for the second quarter of 2006. For the six months ended June 30, 2007, basic and diluted net loss per share was $0.06 as compared to $0.55 for the same period of 2006. The significant improvement in net loss in 2007, as compared to 2006, was principally due to a substantial decrease in research and development expenditures and lower general and administrative expenses, primarily the result of the discontinuation dis·con·tin·u·a·tion n. A cessation; a discontinuance. Noun 1. discontinuation - the act of discontinuing or breaking off; an interruption (temporary or permanent) discontinuance of the development of the Company's Veronate program in 2006, as well as higher revenue and a significant increase in other income for the six months ended June 30, 2007, offset in part by lower net interest income. The Company's results of operations in the second quarter of 2007 include a $0.3 million charge for severance and termination benefits, which was recorded as a general and administrative expense. Revenue for the second quarter of 2007 was $0.7 million as compared to $0.2 million for the second quarter of 2006. For the six months ended June 30, 2007, revenue was $1.4 million as compared to $0.5 million for the same period in 2006. The increase in revenue in 2007 was primarily the result of the amortization of an upfront license fee received in January 2007 and periodic research-associated support fees received by the Company related to the license and development agreement it entered into with 3M Company. Research and development expense for the second quarter of 2007 was $1.7 million, as compared to $6.0 million during the second quarter of 2006. The $4.3 million decrease in 2007 was the result of: a $1.8 million decrease in expenditures for the manufacture of clinical trial materials related to the Veronate program; a $1.0 million decrease in direct clinical trial expenses; a $1.2 million decrease in salaries, benefits and share-based compensation expense related to previously announced staff reductions; and a $0.3 million decrease in various other expenses primarily due to a reduction in sponsored research activities, depreciation and facility-related expenses and the use of laboratory supplies. For the six months ended June 30, 2007 research and development expense decreased to $3.2 million from $13.5 million for the same period in 2006. The $10.3 million decrease was the result of: a $4.0 million decrease in direct clinical trial expenses and a $2.5 million decrease in expenditures for the manufacture of clinical trial materials related to the Veronate program; a $2.3 million decrease in salaries, benefits, and share-based compensation expense related to previously announced staff reductions; and a $1.5 million decrease in various other expenses primarily due to reduced patent-related legal fees, sponsored research activities, depreciation and facility-related expense and the use of laboratory supplies. General and administrative expense decreased to $2.0 million in the second quarter of 2007 as compared to $2.6 million for the second quarter of 2006. The decrease of $0.6 million was primarily the result of: a decrease of $0.5 million in salaries, benefits, and share-based compensation expense associated with previously announced staff reductions; a $0.2 million decrease in market research and professional fees that were incurred in 2006 for the planned commercialization of Veronate that were not incurred in 2007; and a decrease in various other expenses of $0.2 million, offset in part by a $0.3 million charge for severance and termination benefits. For the six months ended June 30, 2007, general and administrative expense decreased to $3.3 million from $5.4 million for the same period in 2006. The decrease of $2.1 million was primarily due to: a $1.3 million reduction in market research and professional fees, which was the result of $0.8 million in market research and professional fees for expenses that were incurred in 2006 for the planned commercialization of Veronate that were not incurred in 2007 and proceeds of $0.5 million received in the first quarter of 2007 from a favorable mediation mediation, in law, type of intervention in which the disputing parties accept the offer of a third party to recommend a solution for their controversy. Mediation has long been a part of international law, frequently involving the use of an international commission, settlement for litigation-related legal fees incurred by the Company in prior years; a decrease of $0.7 million in salaries, benefits and share-based compensation expense associated with previously announced staff reductions; and a decrease in various other expenses of $0.4 million, offset by a $0.3 million charge for severance and termination benefits. The Company recorded total stock compensation expense of $0.4 million, or $0.01 per share, in the second quarter of 2007, of which $0.1 million was recorded as research and development expense and $0.3 million was recorded as general and administrative expense. For the six months ended June 30, 2007, the Company recorded total stock compensation expense of $0.9 million, or $0.03 per share, of which $0.2 million was recorded as research and development expense and $0.7 million was recorded as general and administrative expense. Other income for the six months ended June 30, 2007, increased to $2.0 million from $0.1 million in the same period of 2006 as a result of a gain on the sale of excess raw materials for $1.9 million in 2007. The cash proceeds from this sale were received by the Company in July 2007. Recent Corporate Developments Acquisition of FermaVir - On April 10, 2007, the Company announced that it had entered into a definitive merger agreement with FermaVir. The transaction is being structured as a stock-for-stock exchange. Inhibitex expects an amended S-4 filing for the transaction to be filed and become effective shortly, and subject to approvals by the stockholders of both corporations and the satisfaction of other conditions, the transaction is expected to close in September 2007. Progress with FermaVir Pipeline - FermaVir's development-stage pipeline includes FV-100, a highly potent, orally bioavailable bicyclic nucleoside analogue for the treatment of shingles, and a series of preclinical compounds for the treatment or prevention of CMV. On August 8, 2007, FermaVir announced favorable preclinical results for FV-100 that it and Inhibitex believe support the initiation of a clinical development program for FV-100. The conclusions from the studies were that the compound was safe and well tolerated in rats and dogs over the ranges and duration of exposure examined and that the pharmacokinetics pharmacokinetics /phar·ma·co·ki·net·ics/ (fahr?mah-ko-ki-net´iks) the action of drugs in the body over a period of time, including the processes of absorption, distribution, localization in tissues, biotransformation, and excretion. in both species suggests the potential for a once-a-day dosing regimen regimen /reg·i·men/ (rej´i-men) a strictly regulated scheme of diet, exercise, or other activity designed to achieve certain ends. reg·i·men n. 1. . Separately, a series of CMV compounds are currently being screened for potency potency /po·ten·cy/ (po´ten-se) 1. the ability of the male to perform coitus. 2. the relationship between the therapeutic effect of a drug and the dose necessary to achieve that effect. 3. , toxicity toxicity /tox·ic·i·ty/ (tok-sis´i-te) the quality of being poisonous, especially the degree of virulence of a toxic microbe or of a poison. , and pharmacokinetics, and a decision on the selection of a lead candidate is expected to be made by the end of 2007. Financial Guidance Assuming the completion of the pending FermaVir acquisition in September 2007 as anticipated and subject to the regulatory and clinical progress of its development programs, the Company estimates that its cash burn for the second half of 2007 will range from $10-$12 million, which assumes an estimated $4.5-$5 million reduction in accrued expenses Accrued Expense An accounting expense recognized in the books before it is paid for. It is a liability, usually current. These expenses are typically periodic and documented upon a company's balance sheet due to the high probability of collection. recorded as of June 30, 2007. For the calendar year 2008, the Company anticipates that its net cash burn will range from $11-$13 million. This financial guidance does not consider the financial or operating impact of any other in-licensing, acquisition or merger transaction or advancing the clinical development of Aurexis through a collaboration or otherwise in the future. 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 second quarter 2007 operating results and financial position, the status of the FermaVir transaction and its FV-100 program, as well as provide a general update on the Company via webcast and conference call today at 8:30 a.m. ET. To access the conference call, please dial 866-356-4279 (domestic) or 617-597-5394 (international) and reference the access code 68475069. A replay of the call will be available from 10:30 a.m. EDT EDT abbr. Eastern Daylight Time EDT Eastern Daylight Time EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York EDT on August 9, until September Until September is a 1984 romantic drama set in France. It stars Karen Allen as an American tourist in Paris who falls in love with a married Frenchman (Thierry Lhermitte). External links 8, 2007, at midnight. To access the replay, please dial 888-286-8010 (domestic) or 617-801-6888 (international) and reference the access code 67965064. A live audio webcast of the call and the archived webcast will be available in the Investors section of the Inhibitex website http://www.inhibitex.com under the Upcoming Events category. About Inhibitex Inhibitex, Inc., headquartered in Alpharetta, Georgia Alpharetta is a city in Fulton County, Georgia, United States. As of 2006 census estimates, the city had a total population of 43,424[1]. Selected for its location next to a spring, it began as a campground, and was originally known as , is a biopharmaceutical company focused on the development of products that can treat, prevent or diagnose diagnose /di·ag·nose/ (di´ag-nos) to identify or recognize a disease. di·ag·nose v. 1. To distinguish or identify a disease by diagnosis. 2. serious infections. In addition to its strategy of building a pipeline of antiviral products through in-licensing or acquisition, the Company has several programs and collaborations based upon its proprietary MSCRAMM([R])protein platform, including its Phase II program for Aurexis,a humanized monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing being developed for the treatment of serious staphylococcus aureus Staphylococcus au·re·us n. A bacterium that causes furunculosis, pyemia, osteomyelitis, suppuration of wounds, and food poisoning. Staphylococcus aureus Staphylococcus pyogenes bloodstream blood·stream n. The flow of blood through the circulatory system of an organism. bloodstream the blood flowing through the circulatory system in the living body. infections. The Company has license and collaboration agreements with Wyeth for the development of staphylococcal staphylococcal pertaining to Staphylococcus spp. staphylococcal clumping test used as a means of measuring the quantity of fibrinogen-split products in a sample of blood. vaccines and with 3M, which is developing diagnostics products based on the Company's MSCRAMM platform. For additional information about the Company, please visit www.inhibitex.com. Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement This press release contains forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts included in this press release, including statements regarding the Company's strategic focus on acquiring and developing a pipeline of antiviral development programs; its goal to obtain additional antiviral development programs through in-licensing or acquisition; its goal to enter into a collaboration or determine a pathway to advance the clinical development of Aurexis; the Company's anticipated cash burn in 2007 and 2008; the anticipated closing of the pending transaction with FermaVir; the potential initiation of a single ascending dose study of FV-100 in healthy volunteers; and the potential to identify a lead CMV candidate are forward-looking statements. These plans, intentions, expectations or estimates may not actually be achieved and various important factors could cause actual results or events to differ materially from the forward-looking statements that the Company makes, including risks related to: its ability to find suitable in-licensing, acquisition or merger opportunities for additional antiviral development programs or other third-parties willing to enter into a partnership, collaboration or alliance to advance the clinical development of Aurexis in a timely manner or on acceptable terms and conditions, if at all; Wyeth and/or 3M terminating or revising their respective agreements with the Company; the satisfaction of the conditions to the closing of the pending merger transaction with FermaVir, including approvals by the stockholders of both corporations; the Board of Directors of neither the Company nor FermaVir withdrawing its support for the pending merger transaction; the U.S. Food and Drug Administration, or FDA, permitting the initiation of a single ascending dose study as planned; the continued successful development of FermaVir's product candidates, including satisfactory regulatory activity; obtaining, maintaining and protecting the intellectual property incorporated into and supporting its product candidates; maintaining expenses, revenues and other cash expenditures substantially in line with planned or anticipated amounts; and other cautionary statements contained elsewhere herein and in its Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 2006, as filed with the Securities and Exchange Commission, or SEC, on March 16, 2007, and its Quarterly Report on Form 10-Q Form 10-Q See 10-Q. for March 31, 2007, as filed with the SEC on May 10, 2007. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release. There may be events in the future that the Company is unable to predict accurately, or over which it has no control. The Company's business, financial condition, results of operations, and prospects may change. The Company may not update these forward-looking statements, even though its situation may change in the future, unless it has obligations under the Federal securities laws to update and disclose material developments related to previously disclosed information. The Company qualifies all of the information contained in this press release, and particularly its forward-looking statements, by these cautionary statements. Additional Information about the Merger and Where to Find It In connection with the proposed merger, Inhibitex and FermaVir intend to file relevant materials with the Securities and Exchange Commission (SEC), including a registration statement on Form S-4 that will contain a prospectus and a joint proxy statement Proxy Statement A document containing the information that a company is required by the SEC to provide to shareholders so they can make informed decisions about matters that will be brought up at an annual stockholder meeting. . Investors and security holders of Inhibitex and FermaVir are urged to read these materials when they become available because they will contain important information about Inhibitex, FermaVir and the merger. The proxy statement, prospectus and other relevant materials (when they become available), and any other documents filed by Inhibitex and FermaVir with the SEC, may be obtained free of charge at the SEC's web site at www.sec.gov. In addition, investors and security holders may obtain free copies of the documents filed with the SEC by Inhibitex by directing a written request to: Inhibitex, 9005 Westside Parkway This article contains information about a planned or expected future road. It may contain information of a speculative nature and the content may change as the road's construction or completion approaches and more information becomes available. , Alpharetta, GA 30004, Attention: Investor Relations Investor relations The process by which the corporation communicates with its investors. ; and documents filed with the SEC by FermaVir by directing a written request to FermaVir, 420 Lexington Avenue, Suite 445, New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of , N.Y. 10170, Attention: Investor Relations. Investors and security holders are urged to read the proxy statement, prospectus and the other relevant materials when they become available before making any voting or investment decision with respect to the merger. Participants in the Solicitation solicitation In criminal law, the act of asking, inducing, or directing someone to commit a crime. The person soliciting another becomes an accomplice to the crime. The term also refers to the act of obtaining bribes, as well as to the crime of a prostitute who offers sexual Inhibitex and FermaVir and their respective directors, executive officers and employees may be deemed to be participants in the solicitation of proxies from the stockholders of Inhibitex and FermaVir in connection with the proposed transaction. Information regarding the special interests of these directors and executive officers in the merger transaction will be included in the proxy statement/prospectus referred to above. Additional information regarding the directors and executive officers of Inhibitex is also included in Inhibitex's Amendment No. 1 to the Annual Report on Form 10-K for year ended December 31, 2006. This document is available free of charge at the SEC's web site (www.sec.gov) and from Investor Relations at Inhibitex at the address set forth above. Additional information regarding the directors and executive officers of FermaVir is also included in FermaVir's Annual Report on Form 10-KSB for the year ended April 30, 2007. This document is available free of charge at the SEC's web site (www.sec.gov) and from Investor Relations at FermaVir at the address set forth above. Inhibitex([R]), MSCRAMM([R]), Veronate([R]), and Aurexis([R]) are registered trademarks of Inhibitex, Inc. [TABLE OMITTED] [TABLE OMITTED] |
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