Inhibitex, Inc. (Nasdaq: INHX), today announced its financial
results for the first quarter ended March 31, 2009. The Company
held cash, cash equivalents and short-term investments of $29.2
million at March 31, 2009, as compared to $33.1 million at December
31, 2008.
�We continue to make notable progress with FV-100 and our HCV
nucleoside polymerase inhibitor program,� stated Russell H. Plumb,
president and chief executive officer of Inhibitex, Inc. �We have
initiated a Phase II trial with FV-100, which we foresee completing
around the middle of next year. We have also commenced IND-enabling
preclinical studies with a lead compound, INX-189, from our highly
potent series of NS5b inhibitors. We recently presented preclinical
data on INX-189, demonstrating its favorable potency,
pharmacokinetic and toxicity profile. We believe that nucleoside
polymerase inhibitors have the potential to play a pivotal role in
the combination of direct antiviral therapies for the treatment of
HCV infections, and we look forward to completing the requisite GLP
preclinical studies with INX-189 that will support the filing of an
IND in the first half of next year.�
First Quarter 2009 Financial Results
The Company reported a net loss for the first quarter of 2009 of
$4.2 million, as compared to a net loss of $3.5 million in the
first quarter of last year. Basic and diluted net loss per share
was $0.10 for the first quarter of 2009 as compared to basic and
diluted net loss per share of $0.08 per share for the first quarter
of 2008. The increase in net loss and net loss per share in the
first quarter of 2009 was the result of lower revenues from
collaborative license and development agreements, lower net
interest income and higher research and development expense, offset
by a reduction in general and administrative expense.
Revenue for the first quarter of 2009 was $0.3 million as
compared to $0.8 million in the first quarter of 2008. The $0.5
million decrease in revenue was primarily the result of certain
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 $3.5 million in
the first quarter of 2009 from $3.4 million in the first quarter of
2008. The increase of $0.1 million was primarily the result of an
increase of $0.3 million in direct costs incurred in connection
with the clinical development of FV-100 and the Company�s HCV
preclinical development program, offset by a $0.2 million decrease
in salaries, benefits and share-based compensation.
General and administrative expense decreased to $1.1 million in
the first quarter of 2009 from $1.3 million in the first quarter of
2008. This decrease of $0.2 million was primarily related to a
decrease in salaries, benefits and share-based compensation.
The Company recorded non-cash, share-based compensation expense
of $0.2 million in the first quarter of 2009, of which $0.1 million
was recorded as research and development expense and $0.1 million
as general and administrative expense.
For the quarter ended March 31, 2009, net interest income
decreased to $0.1 million from $0.5 million in the first quarter of
2008 as a result of lower interest rates and lower cash and
investment balances.
Recent Corporate Developments
FV-100 � On May 8, 2009 the Company reported it had initiated a
Phase II clinical trial of FV-100, its highly potent compound in
development for the treatment of herpes zoster (shingles). The
Phase II clinical trial is a well-controlled, double-blind
randomized study comparing two different once-a-day doses of FV-100
to an active control (valacyclovir). The Company anticipates
enrolling approximately 350 patients in the trial, who will be
equally randomized to one of the three treatment arms. In addition
to further evaluating its safety, the objectives of the trial
include: evaluating the therapeutic benefit of FV-100 in reducing
the severity and duration of acute shingles-related pain; the
incidence of post herpetic neuralgia (PHN); the time to lesion
healing; and the use of concomitant pain medications.
In February 2009, the Company reported that it had completed its
Phase I clinical trials of FV-100. The trials included both a
single and multiple ascending dose study in subjects aged 18-55, as
well as a separate study conducted in subjects 65 years of age or
older. The Company reported that in all three trials there were no
serious adverse events reported, and FV-100 appeared to be well
tolerated at all dose levels. Additionally, pharmacokinetic data
demonstrated that all doses of FV-100 maintained mean plasma levels
of its active form that support the evaluation of once-a-day dosing
in Phase II. The Company recently presented data from its Phase I
studies at the 22nd Annual International Conference on Antiviral
Research (ICAR).
HCV Nucleoside Polymerase Inhibitors - The Company has selected
a lead compound, INX-189, from its series of proprietary HCV
nucleoside polymerase inhibitors for further evaluation in
IND-enabling preclinical studies. The Company presented preclinical
data from its HCV program at the 44th Annual Meeting of the
European Association for the Study of the Liver (EASL) in April and
at ICAR earlier this month.
NASDAQ Listing Transfer � On March 24, 2009, the Company
received written notification that NASDAQ had suspended enforcement
of its minimum bid price and market valuation requirement for all
listed companies until July 20, 2009, and that based upon NASDAQ�s
decision, the Company has until October 12, 2009 to regain
compliance with NASDAQ's minimum bid price requirement.
Conference Call and Webcast Information
Russell H. Plumb, president and chief executive officer of
Inhibitex, Inc. and other members of management will review the
Company�s first 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. EST.
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 May 12 until June 12, 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 # 322241. A live audio webcast
of the call and the archived webcast will be available in the News
and Events section of the Inhibitex website at
http://www.inhibitex.com.
About Shingles and FV-100
Shingles, also known as herpes zoster, is an infection caused by
the reactivation of varicella zoster virus (VZV), the same virus
that causes chicken pox. Worldwide, it is estimated that there are
more than 2.5 million new cases of shingles each year. Shingles is
generally characterized by skin lesions, acute infection-related
pain, and in many cases, post herpetic neuralgia (PHN), a painful
and sometimes debilitating condition that can last for months or
possibly more than a year. While shingles can develop in
adolescents or adults of any age, it occurs predominantly in those
40 years of age and older.
Published in vitro studies have demonstrated that FV-100, an
orally available bicyclic nucleoside analogue, is 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 its
pharmacokinetic profile, support the potential for a once daily
dose of FV-100 to reduce the severity, duration and incidence of
shingles-related symptoms, including acute pain and PHN.
About HCV
Hepatitis C is a disease of the liver caused by the hepatitis C
virus (HCV). It is estimated that approximately 4 million Americans
and 170 million individuals worldwide are infected with HCV. HCV
can cause chronic liver disease, cirrhosis and cancer, and is the
leading cause of liver transplant in the United States. Inhibitex
is developing a series of phosphoramidate nucleoside analogues, or
protides, which target the RNA-dependent RNA polymerase (NS5b) of
HCV. The Company believes that its protides possess several
pharmacological advantages over nucleosides alone, including a
significant increase in antiviral activity, higher concentrations
of the triphosphate in liver, and potentially less toxicity due to
reduced systemic exposure.
About Inhibitex
Inhibitex, Inc., headquartered in Alpharetta, Georgia, is a
biopharmaceutical company focused on developing products to treat
serious infectious diseases. In addition to FV-100, its
clinical-stage product candidate, the Company�s preclinical
pipeline includes a series of HCV nucleoside polymerase and HIV
integrase inhibitors. Inhibitex has also licensed the use of its
proprietary MSCRAMM� protein technology to Wyeth for 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 potential to complete the Phase
II clinical trial of FV-100 around the middle of next year; the
number of patients the Company plans to enroll in its Phase II
trial of FV-100; the potential for nucleoside polymerase inhibitors
to play a pivotal role in the combination of direct antiviral
therapies for HCV; the potential for FV-100 to be dosed once-a-day
and reduce the severity, duration and incidence of shingles-related
symptoms, including acute pain and PHN; the Company�s belief that
its HCV protides possess several pharmacological advantages over
nucleosides alone; and the Company�s plan to complete IND enabling
studies and file an IND for INX-189 in the first half of 2010, are
forward looking statements. These intentions, expectations, or
potential 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 that: the Company is not able to qualify a
sufficient number of sites or enroll patients at its anticipated
rate in the Phase II trial; either the Company, the FDA, or a
safety review board suspends or terminates the Phase II trial of
FV-100 for safety, manufacturing or other reasons; the safety
results of the Phase II clinical trial of FV-100 do not support its
further development; FV-100 does not prove to have a therapeutic
benefit equal to or greater than valacyclovir in reducing
shingles-related symptoms in patients to be clinically relevant or
commercially viable; the results of future preclinical studies of
the Company�s lead HCV candidate not supporting its further
development; the Company not obtaining regulatory approval on a
timely basis, or at all, to advance the development of an HCV
clinical candidate into clinical trials; 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, 2008, as filed with the Securities and Exchange
Commission, or SEC, on March 23, 2009. 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)
� � �
March 31, �
December 31, 2009
2008 �
ASSETS Current assets: Cash and cash
equivalents $ 8,486,293 $ 11,507,137 Short-term investments
20,702,172 21,634,880 Prepaid expenses and other current assets
557,731 621,797 Accounts receivable �
157,524 � �
108,558 � Total current assets 29,903,720 33,872,372
Property and equipment, net. 2,137,074 2,328,707 Other long-term
assets �
32,533 � �
31,876 � Total assets
$ 32,073,327 �
$
36,232,955 � � �
LIABILITIES AND STOCKHOLDERS�
EQUITY Current liabilities: Accounts payable $ 1,705,638 $
1,276,215 Accrued expenses 1,030,641 1,001,047 Current portion of
notes payable 312,500 312,500 Current portion of capital lease
obligations 190,718 254,291 Current portion of deferred revenue
191,667 441,667 Other current liabilities �
204,031 �
�
224,922 � Total current liabilities 3,635,195
3,510,642 Long-term liabilities: Notes payable, net of current
portion 312,500 390,625 Capital lease obligations, net of current
portion 338,237 387,892 Deferred revenue, net of current portion
200,000 237,500 Other liabilities, net of current portion �
1,238,376 � �
1,279,994 � Total long-term
liabilities �
2,089,113 � �
2,296,011 �
Total liabilities 5,724,308 5,806,653 Stockholders' equity:
Preferred stock, $.001 par value; 5,000,000 shares authorized at
March 31, 2009 and December 31, 2008; none issued and outstanding �
� Common stock, $.001 par value; 75,000,000 shares authorized at
March 31, 2009 and December 31, 2008; 43,509,860 and 43,380,570
shares issued and outstanding at March 31, 2009 and December 31,
2008, respectively 43,510 43,381 Common stock warrants 13,742,231
13,742,630 Additional paid-in capital 244,000,488 243,825,057 Other
comprehensive income 54,689 111,450 Accumulated deficit �
(231,491,899 ) �
(227,296,216 ) Total
stockholders' equity �
26,349,019 � �
30,426,302 � Total liabilities and stockholders'
equity
$
32,073,327
�
$
36,232,955
� � �
INHIBITEX, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(unaudited)
� �
Three Months Ended March 31, 2009 �
2008 Revenue: License fees and milestones $ 37,500 $ 412,500
Collaborative research and development � 250,000 � � 375,000 �
Total revenue 287,500 787,500 Operating expense: Research and
development 3,497,060 3,406,047 General and administrative �
1,071,490 � � 1,341,568 � Total operating expense � 4,568,550 � �
4,747,615 � Loss from operations (4,281,050 ) (3,960,115 ) Other
income (loss), net (8,151 ) 11,426 Interest income, net � 93,518 �
� 500,890 �
Net loss
$
(4,195,683
)
$
(3,447,799
)
� �
Basic and diluted net loss per
share
$ (0.10 ) $
(0.08 ) � Weighted average shares used to
compute basic and diluted net loss per share � 43,427,976 � �
42,791,069 �
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