INHX Inhibitex, Inc. (MM)

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,” 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.

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 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, dial (877) 407-9210 (domestic) or (201) 689-8049 (international). A replay of the call will be available from 11:00 a.m. EDT on August 11 until September 10, 2010 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 # 354732. 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.

About Shingles and FV-100

The Company is developing FV-100 to treat herpes zoster, also commonly referred to as shingles, which is an infection caused by the reactivation of varicella zoster virus (VZV), the same virus that causes chicken pox. Published in vitro studies have demonstrated that FV-100, an orally available nucleoside analogue, is significantly more potent against VZV and can inhibit its replication substantially faster than any other antiviral agent currently approved for the treatment of shingles. Inhibitex believes these characteristics, plus a favorable pharmacokinetic profile, support the potential of FV-100 as a highly potent, once-daily oral therapy to reduce the incidence, severity and duration of shingles-related symptoms, including acute pain and post herpetic neuralgia (PHN).

About HCV and INX-189

Hepatitis C is a disease of the liver caused by the hepatitis C virus (HCV), which causes liver disease, cirrhosis and cancer, and is the leading cause of liver transplants in the United States. Inhibitex is developing a series of proprietary nucleotide inhibitors, which it refers to as protides, which target and inhibit the RNA-dependent RNA polymerase (NS5b) of HCV. The Company believes that INX-189 is the most potent HCV nucleotide polymerase inhibitor in clinical development, and that preclinical studies of INX-189 support its potential as a highly potent, once-per-day oral therapy amenable to low fixed-dose combination with other antivirals for the treatment of patients with chronic hepatitis C infections.

About Inhibitex

Inhibitex, Inc., headquartered in Alpharetta, Georgia, is a biopharmaceutical company focused on developing products to treat and prevent serious infectious diseases. In addition to its two clinical-stage programs, FV-100 and INX-189, the Company’s pipeline includes other HCV nucleotide inhibitors in preclinical development. It has also licensed its proprietary MSCRAMM® protein platform to Pfizer for its use in the development of staphylococcal vaccines.

For additional information about the Company, please visit www.inhibitex.com.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than historical facts included in this press release, including statements regarding: the anticipated time when top-line data from the ongoing Phase II clinical trial of FV-100 will be available; the potential for FV-100 to be dosed once-per-day and reduce the incidence, severity and duration of shingles-related symptoms, including acute pain and PHN; the anticipated time when the ongoing, first-in-man single ascending dose study of INX-189 will be completed; the Company’s plans to advance INX-189 into a Phase 1b multiple ascending dose study; the Company’s belief that INX-189 is the most potent HCV nucleotide polymerase inhibitor in clinical development; and the results of preclinical studies of INX-189 supporting its potential as a highly potent, once-per-day oral therapy amenable to low fixed dose combination with other antivirals for the treatment of patients with chronic hepatitis C infection are forward looking statements. These intentions, expectations, or results may not be achieved in the future and various important factors could cause actual results or events to differ materially from the forward-looking statements that the Company makes, including the risk of: the Company, the FDA, a DSMB, or an institutional review board (IRB) delaying, suspending or terminating the clinical development of FV-100 or INX-189 at any time for a lack of safety or tolerability, manufacturing issues or any other reason; FV-100 not demonstrating sufficient efficacy in reducing the incidence and severity of shingles-related symptoms, including acute pain and PHN, to be clinically relevant or commercially viable; undisclosed data demonstrating the existence of a more potent HCV nucleotide inhibitor in clinical development; obtaining, maintaining and protecting the intellectual property incorporated into and supporting the commercial viability of the Company’s product candidates; and other cautionary statements contained elsewhere herein and in its Annual Report on Form 10-K for the year ended December 31, 2009, as filed with the Securities and Exchange Commission, or SEC, on March 26, 2010 and its Quarterly Reports on Form 10-Q for the quarter ended March 31, 2010, as filed with the SEC on May 13, 2010. 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.

Inhibitex® and MSCRAMM® are registered trademarks of Inhibitex, Inc.

 

INHIBITEX, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(unaudited)

      June 30,     December 31, 2010 2009   ASSETS Current assets: Cash and cash equivalents $ 6,907,451 $ 11,290,332 Short-term investments 22,390,181 26,625,496 Prepaid expenses and other current assets 678,726 831,196 Accounts receivable   67,857     61,062   Total current assets 30,044,215 38,808,086 Property and equipment, net. 1,340,401 1,621,392 Other long-term assets   35,683     40,290   Total assets $ 31,420,299   $ 40,469,768       LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $ 2,304,142 $ 1,590,804 Accrued expenses 1,418,515 1,537,637 Current portion of notes payable 121,528 78,125 Current portion of capital lease obligations 218,884 207,100 Current portion of deferred revenue 441,667 191,667 Other current liabilities   228,835     202,531   Total current liabilities 4,733,571 3,807,864 Long-term liabilities: Notes payable, net of current portion 425,347 546,875 Capital lease obligations, net of current portion 68,313 180,792 Deferred revenue, net of current portion 12,500 87,500 Other liabilities, net of current portion   986,562     1,096,629   Total long-term liabilities   1,492,722     1,911,796   Total liabilities 6,226,293 5,719,660 Stockholders' equity: Preferred stock, $.001 par value; 5,000,000 shares authorized at June 30, 2010 and December 31, 2009; none issued and outstanding — — Common stock, $.001 par value; 150,000,000 shares authorized at June 30, 2010 and December 31, 2009; 62,135,924 and 61,559,782 shares issued and outstanding at June 30, 2010 and December 31, 2009, respectively 62,136 61,560 Common stock warrants 11,631,670 12,133,216 Accumulated other comprehensive (loss) income (1,683 ) 8,977 Additional paid-in capital 268,740,043 267,432,572 Accumulated deficit   (255,238,160 )   (244,886,217 ) Total stockholders' equity   25,194,006     34,750,108   Total liabilities and stockholders' equity $ 31,420,299   $ 40,469,768    

INHIBITEX, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

        Three Months Ended Six Months Ended June 30, June 30, 2010     2009 2010     2009 Revenue: License fees and milestones $ 37,500 $ 37,500 $ 786,667 $ 75,000 Collaborative research and development   250,000    

250,000

    500,000    

500,000

  Total revenue 287,500 287,500 1,286,667 575,000 Operating expense:

Research and development

4,915,899 3,680,548 9,705,514 7,177,608

General and administrative

  958,834     937,354     1,982,875     2,008,844   Total operating expense   5,874,733     4,617,902     11,688,389     9,186,452   Loss from operations (5,587,233 ) (4,330,402 ) (10,401,722 ) (8,611,452 ) Other (expense) income, net 12,194 46,223 15,714 38,072 Interest income, net   16,249     54,921     34,065     148,439  

Net loss

$ (5,558,790 )

$

(4,229,258

)

$ (10,351,943 )

$

(8,424,941

)

   

Basic and diluted net loss per share

$ (0.09 ) $ (0.10 ) $ (0.17 ) $ (0.19 )   Weighted average shares used to compute basic and diluted net loss per share   61,835,222     43,524,715     61,698,884     43,476,613