Inhibitex, Inc. (NASDAQ:INHX) (the “Company”) today announced
its financial results for the third quarter ended September 30,
2010 and its recent corporate developments.
“With the recent completion of enrollment in our Phase 2 trial
of FV-100 in shingles patients and the initiation of a Phase 1b
trial of INX-189 in patients with chronic hepatitis C, we are now
positioned to have top-line data available from both of these
important proof of concept studies during the next several months,”
stated Russell H. Plumb, President and CEO of Inhibitex, Inc. “We
particularly welcome the opportunity to assess the anticipated
anti-viral synergy of INX-189 in combination with ribavirin for
seven days in our Phase 1b study, which we believe will allow us to
better define the appropriate doses of INX-189 to consider
evaluating in future clinical trials.”
Third Quarter Financial Results
As of September 30, 2010, the Company held $24.2 million in
cash, cash equivalents and short-term investments.
The Company reported a net loss in the third quarter of 2010 of
$5.3 million, as compared to a net loss of $4.5 million in the
third quarter of 2009. Basic and diluted net loss per share was
$0.08 for the third quarter of 2010 as compared to $0.10 in the
third quarter of 2009. The $0.8 million increase in net loss in the
third quarter of 2010 was attributable to higher research and
development expenses. The decrease in net loss per share for the
third quarter of 2010 was the result of an 18.7 million 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 $4.7 million in
the third quarter of 2010 from $3.9 million in the third quarter of
2009 due to a $0.8 million increase in direct costs incurred in
connection with the initiation of a Phase 1a clinical trial of
INX-189 in May of 2010 and the ongoing enrollment of the Phase 2
clinical trial of FV-100.
Recent Corporate Developments
FV-100 for Shingles – In October 2010, the Company announced
that it had completed enrollment in a Phase 2 clinical trial of
FV-100 in shingles (herpes zoster) patients. The objectives of the
trial are to further evaluate the safety of FV-100 and its
potential therapeutic benefit in reducing the severity and duration
of shingles-associated pain, the incidence of post herpetic
neuralgia (PHN), and the time to heal shingles-related lesions. The
Phase 2 trial is a well-controlled, double-blind study of 350
shingles patients, aged 50 years and older with shingles-associated
pain, randomized equally to one of three treatment arms: 200 mg or
400 mg FV-100 administered orally once daily, or 1,000 mg
valacyclovir administered orally three times per day. The Company
anticipates top-line data from the trial will be available later
this quarter.
INX-189 for Chronic Hepatitis C – In November 2010, the Company
announced that it had initiated a Phase1b, multiple ascending dose
(MAD) clinical trial of INX-189, its nucleotide polymerase
inhibitor in development for the treatment of chronic infections
caused by hepatitis C virus (HCV). The trial, which is being
conducted under an IND in the United States, is a double-blind,
placebo-controlled, dose escalation study designed to evaluate the
safety, tolerability, pharmacokinetics and anti-viral activity of
INX-189, administered orally once-daily, in treatment naïve
patients with HCV genotype 1. Each treatment cohort will include 10
patients, eight of which will receive INX-189 and two of which will
receive placebo. The first cohort in the Phase 1b study will
receive 9 mg of INX-189 once daily. In addition to evaluating
INX-189 as monotherapy, the Company intends to evaluate two dose
levels of INX-189, administered once-daily for seven days, in
combination with ribavirin, which is one of the drugs currently
approved for the treatment of HCV. The dose levels of INX-189 to be
evaluated in combination with ribavirin will be determined based
upon the results of the monotherapy cohorts. The Company
anticipates that top-line safety and anti-viral data from this
trial will be available in the first quarter of 2011.
In September 2010, the Company announced that it has
successfully completed a Phase1a, first-in-man, single ascending
dose trial of INX-189. In this trial, 42 healthy volunteers
received either a single oral dose of INX-189, ranging from 3 mg to
100 mg, or placebo. The Company plans to present detailed results
from this trial during a future scientific meeting. Preliminary
data from the Phase 1a trial indicated that INX-189 was generally
well tolerated at all dose levels; there were no drug-related
serious adverse events, no dose-related trends in frequency or type
of adverse events, and no grade II or higher laboratory abnormality
adverse events or clinically significant changes in ECGs.
Furthermore, the Company believes that the pharmacokinetic data
from this study further supports INX-189’s potential for once-daily
(QD) dosing.
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 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. EST. 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. EST on November 10 until December 9, 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 # 359917. 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 bicyclic nucleoside
analogue, is significantly more potent against VZV and can inhibit
its replication substantially faster than any other anti-viral
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 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
Chronic hepatitis C is a disease of the liver caused by 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,
referred to as protides, which target and inhibit the RNA-dependent
RNA polymerase (NS5b) of HCV. The Company believes that, based on
in vitro data, INX-189 is the most potent HCV nucleotide polymerase
inhibitor currently in clinical development, and that preclinical
studies of INX-189 support its potential as a potent, once-daily
oral therapy amenable to low fixed-dose combination with other
anti-virals for the treatment of patients with chronic hepatitis C
infections.
About Inhibitex
Inhibitex, Inc. 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-daily and
reduce the incidence, severity and duration of shingles-related
symptoms, including acute pain and PHN; the Company’s plans to
present detailed results from its Phase 2 FV-100 trial during a
future scientific meeting. the Company’s belief that INX-189 is the
most potent HCV nucleotide polymerase inhibitor currently in
clinical development; the results of preclinical studies of INX-189
supporting its potential as a potent, once-daily oral therapy
amenable to low fixed dose combination with other anti-virals; the
Company’s belief that the pharmacokinetic data from a recently
completed Phase 1a trial further supports INX-189’s potential for
once-daily dosing; the anticipated anti-viral synergy of INX-189
dosed in combination with ribavirin allowing the Company to better
define the most appropriate doses of INX-189 to consider evaluating
in future clinical trials; and the anticipated time when top-line
safety and anti-viral data will be available from the Phase 1b
trial of INX-189, 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 data
safety monitoring board, 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, tolerability,
anti-viral activity, or any other reason; FV-100 not demonstrating
sufficient activity or potential 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; the Company or its clinical
investigators not being able to enroll HCV patients in the Phase 1b
trial on a timely basis; INX-189 not demonstrating any meaningful
anti-viral synergy with ribavirin in patients enrolled in the Phase
1b trial and thereby not providing any additional insight as to
which doses of INX-189 to consider in future combination studies,
if any; 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 and June 30, 2010, as filed with the SEC on May 13, 2010 and
August 12, 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)
September 30, December 31, 2010
2009 ASSETS Current
assets: Cash and cash equivalents $ 9,059,783 $ 11,290,332
Short-term investments 15,117,103 26,625,496 Prepaid expenses and
other current assets 580,125 831,196 Accounts receivable
63,797 61,062 Total
current assets 24,820,808 38,808,086 Property and equipment, net.
1,226,699 1,621,392 Other long-term assets
42,110 40,290 Total
assets
$ 26,089,617 $
40,469,768 LIABILITIES AND
STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $
1,656,587 $ 1,590,804 Accrued expenses 2,102,460 1,537,637 Current
portion of notes payable 182,292 78,125 Current portion of capital
lease obligations 212,618 207,100 Current portion of deferred
revenue 166,667 191,667 Other current liabilities
234,309 202,531
Total current liabilities 4,554,933 3,807,864 Long-term
liabilities: Notes payable, net of current portion 364,583 546,875
Capital lease obligations, net of current portion 22,113 180,792
Deferred revenue, net of current portion — 87,500 Other
liabilities, net of current portion
927,681
1,096,629 Total long-term
liabilities
1,314,377
1,911,796 Total liabilities 5,869,310 5,719,660
Stockholders' equity: Preferred stock, $.001 par value; 5,000,000
shares authorized at September 30, 2010 and December 31, 2009; none
issued and outstanding — — Common stock, $.001 par value;
150,000,000 shares authorized at September 30, 2010 and December
31, 2009; 62,280,110 and 61,559,782 shares issued and outstanding
at September 30, 2010 and December 31, 2009, respectively 62,280
61,560 Common stock warrants 11,281,056 12,133,216 Accumulated
other comprehensive income 6,502 8,977 Additional paid-in capital
269,382,091 267,432,572 Accumulated deficit
(260,511,622 )
(244,886,217 )
Total stockholders' equity
20,220,307
34,750,108 Total liabilities and
stockholders' equity
$ 26,089,617
$ 40,469,768
INHIBITEX, INC.
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
(unaudited)
Three Months Ended Nine Months Ended
September 30, September 30, 2010
2009 2010
2009 Revenue: License fees and milestones $
37,500 $ 37,500 $ 824,167 $ 112,500 Collaborative research and
development 250,000
250,000
750,000
750,000
Total revenue 287,500 287,500 1,574,167 862,500 Operating
expense:
Research and development
4,700,987 3,945,464 14,406,501 11,123,072
General and administrative
877,177 831,264 2,860,052
2,840,108 Total operating expense 5,578,164
4,776,728 17,266,553
13,963,180 Loss from operations (5,290,664 ) (4,489,228 )
(15,692,386 ) (13,100,680 ) Other (expense) income, net (1,107 )
1,562 14,607 39,634 Interest income, net 18,309
15,929 52,374 164,368
Net loss
$ (5,273,462 )
$
(4,471,737
)
$ (15,625,405 )
$
(12,896,678
)
Basic and diluted net loss per
Share
$ (0.08 ) $
(0.10 ) $ (0.25
) $ (0.30 )
Weighted average shares used to compute basic and diluted
net loss per share 62,248,265 43,545,057
61,884,023 43,499,678
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