Inhibitex, Inc. (NASDAQ: INHX) today announced its financial
results for the fourth quarter and year ended December 31,
2008.
�We are pleased with the progress we have made over the last
year, resulting in the achievement of three primary goals,� stated
Russell H. Plumb, President and CEO of Inhibitex, Inc. �These goals
were to successfully complete our Phase I program for FV-100,
identify a lead candidate from our series of HCV nucleoside
polymerase inhibitors for further preclinical development, and
reduce our overhead costs to extend our cash runway in this
challenging business environment. Accordingly, we believe we are
well positioned to move our development programs to the next level
in 2009. Subject to FDA review, we plan on initiating a Phase II
clinical trial of FV-100 in shingles patients in the second quarter
of 2009. Further, we are encouraged with the preclinical data
observed to-date with respect to several of our HCV compounds, and
consequently have initiated advanced preclinical studies with a
lead candidate. Subject to the successful completion of all
requisite IND-enabling studies, our goal is to file an IND for our
HCV program in the first half of 2010. Finally, we ended 2008 with
over $33 million on hand, which exceeded our year-end cash target
and supports our development goals through 2009 and into the second
half of 2010.�
Fourth Quarter 2008 Financial Results
As of December 31, 2008, the Company reported that it held $33.1
million in cash, cash equivalents and short-term investments. The
Company reported a net loss for the fourth quarter of 2008 of $3.5
million, which was the same net loss as the fourth quarter of 2007.
Further, basic and diluted net loss per share was $0.08 for the
fourth quarter of both 2008 and 2007.
Revenue for the fourth quarter of both 2008 and 2007 was $0.8
million. Revenue consists of periodic research-associated support
and license fees recognized by the Company related to existing
license and development agreements.
Research and development expense for the fourth quarter of 2008
was $3.6 million, as compared to $3.5 million in the fourth quarter
of 2007. The $0.1 million increase in 2008 was primarily the result
of a $0.4 million increase in direct costs associated with the
clinical development of FV-100 and the Company�s HCV and HIV
preclinical development programs, offset by a $0.3 million decrease
in various indirect expenses.
General and administrative expense decreased to $1.0 million in
the fourth quarter of 2008 from $1.5 million in the fourth quarter
of 2007. The decrease of $0.5 million was primarily the result of a
$0.2 million reduction in salaries, benefits and share-based
compensation and a $0.3 million decrease in facility-related and
other various expenses.
The Company recorded total share-based compensation expense of
$0.2 million, or $0.01 per share, in the fourth quarter of 2008, of
which $0.1 million was recorded as research and development expense
and $0.1 million as general and administrative expense.
For the twelve months ended December 31, 2008, the Company
reported a net loss of $13.2 million, as compared to $41.5 million
for the same period in 2007. Basic and diluted net loss per share
for the twelve months ended December 31, 2008 was $0.31, as
compared to $1.22 for the same period of 2007. The significant
decrease in net loss and net loss per share for the twelve months
ended December 31, 2008 was primarily due to a non-cash, in-process
research and development charge of $32.6 million the Company
recorded in the third quarter of 2007 in connection with its
acquisition of FermaVir Pharmaceuticals, Inc., as well as an
increase in revenue and a decrease in general and administrative
expense, offset in part by an increase in research and development
expense associated with the clinical development of FV-100 and the
preclinical development of the Company�s HCV nucleoside polymerase
inhibitor program, and a decrease in other income and net interest
income in 2008.
Recent Corporate Developments
FV-100 � In February 2009, the Company reported that it had
completed its planned Phase I clinical trials of FV-100. The
recently completed trials include both a multiple ascending dose
study in subjects aged 18-55 and a separate study conducted in
subjects 65 years of age or older. The Company reported that in
both 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
maintained mean plasma levels of the active form of FV-100 that
support the evaluation of once-a-day dosing in future trials. These
safety and pharmacokinetic findings were consistent with those
observed in the Company�s Phase I single ascending dose trial, the
results of which were reported at ICAAC last year. The Company
plans to present the full data from these studies at the 22nd
Annual International Conference on Antiviral Research (ICAR) in
Miami, Florida, May 3-7, 2009.
HCV Nucleoside Polymerase Inhibitors - In February 2009, the
Company also reported it had selected several compounds from its
series of proprietary HCV nucleoside polymerase inhibitors for
further evaluation in additional preclinical studies. The decision
to proceed into these studies was based on favorable results from
completed in vitro and preclinical in vivo studies, in which the
candidates demonstrated excellent potency in various HCV replicon
assays, a rapid conversion to the triphosphate in human
hepatocytes, and favorable pharmacokinetic and toxicity properties
in orally dosed primates and rodents. The Company plans on
presenting preclinical data from this program at the 44th Annual
Meeting of the European Association for the Study of the Liver
(EASL), in Copenhagen, Denmark, April 22 � 26, 2009 and at the 22nd
Annual International Conference on Antiviral Research (ICAR) in
Miami, Florida, May 3-7, 2009.
NASDAQ Listing Transfer � On December 23, 2008, the Company
received written notification that NASDAQ had suspended enforcement
of its minimum bid price and market valuation requirement for all
listed companies until April 20, 2009, and that based upon NASDAQ�s
decision, the Company has until July 10, 2009 to regain compliance
with NASDAQ's minimum bid price requirement.
License and Development Agreement with 3M - The Company was
notified by 3M that it has discontinued its efforts to further
develop and commercialize certain antibody-based diagnostics for
infectious diseases and therefore will conclude its license and
commercialization agreement with the Company effective March 22,
2009. As a result, all MSCRAMM-related intellectual property
sublicensed to 3M for the development of antibody-based infectious
disease diagnostics will revert back to the Company. The
termination of this agreement will not have any effect on the
Company�s current or planned operating results or financial
position.
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 fourth quarter 2008 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 March 13 until April 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 # 316302. 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
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
greater than 2.5 million 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 a
favorable pharmacokinetic profile, provides the potential for a
once-a-day dose of FV-100 to reduce the incidence and severity 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, which include a
significant increase in antiviral activity, higher concentrations
of the triphosphate in liver, improved bioavailability 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
and prevent serious infectious diseases. In addition to FV-100 and
its HCV nucleoside polymerase inhibitors, the Company�s preclinical
pipeline includes a series of 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 Company being well positioned to
move its development programs to the next level in 2009; the
anticipated timing and initiation of a Phase II clinical trial of
FV-100; the potential for FV-100 to be dosed once-a-day and reduce
the incidence and severity of shingles-related symptoms, including
acute pain and PHN; plans to present full data from its Phase I
studies of FV-100 at the ICAR meeting in May 2009; plans to present
preclinical data on its HCV compounds at the EASL meeting in April
2009 and at the ICAR meeting in May 2009; the Company�s belief that
its HCV protides possess several pharmacological advantages over
nucleosides alone; the Company�s goal to file an IND for its HCV
program in the first half of 2010; and the length of time that
existing cash resources may support the Company�s operations and
development plans 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 of: the Company not obtaining
regulatory approval on a timely basis, or at all, to advance the
development of an HCV clinical candidate into clinical trial or
FV-100 into Phase II clinical trials; either the Company, the FDA,
or an investigational review board suspending or terminating the
clinical development of FV-100 for lack of safety, manufacturing
issues or other clinical reasons; 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; the results of ongoing
or future preclinical studies of the Company�s lead HCV candidate
not supporting its further development; obtaining, maintaining and
protecting the intellectual property incorporated into and
supporting the commercial viability of the Company�s product
candidates; the Company not being able to maintain 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
for the year ended December 31, 2007, as filed with the Securities
and Exchange Commission, or SEC, on March 14, 2008 and its
Quarterly Reports on Form 10-Q for the quarters ended March 31,
2008, June 30, 2008 and September 30, 2008, as filed with the SEC
on May 9, 2008, August 12, 2008 and November 10, 2008,
respectively. 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)
� �
December 31, �
December 31, 2008
2007 �
ASSETS Current assets: Cash and cash
equivalents $ 11,507,137 $ 14,178,143 Short-term investments
21,634,880 36,088,309 Prepaid expenses and other current assets
621,797 1,058,426 Accounts receivable �
108,558 �
44,988 Total current assets 33,872,372 51,369,866
Property and equipment, net. 2,328,707 2,564,345 Other long-term
assets �
31,876 �
� Total assets
$ 36,232,955 $
53,934,211 �
LIABILITIES AND STOCKHOLDERS�
EQUITY Current liabilities: Accounts payable $ 1,276,215 $
1,160,351 Accrued expenses 1,001,047 6,605,253 Current portion of
notes payable 312,500 312,500 Current portion of capital lease
obligations 254,291 698,151 Current portion of deferred revenue
441,667 441,667 Other current liabilities �
224,922 �
154,824 Total current liabilities 3,510,642 9,372,746
Long-term liabilities: Notes payable, net of current portion
390,625 703,125 Capital lease obligations, net of current portion
387,892 68,710 Deferred revenue, net of current portion 237,500
387,500 Other liabilities, net of current portion �
1,279,994 �
1,202,328 Total long-term
liabilities �
2,296,011 �
2,361,663 Total
liabilities 5,806,653 11,734,409 Stockholders' equity: Preferred
stock, $.001 par value; 5,000,000 shares authorized at December 31,
2008 and December 31, 2007; none issued and outstanding � � Common
stock, $.001 par value; 75,000,000 shares authorized at December
31, 2008 and December 31, 2007; 43,380,570 and 42,785,318 shares
issued and outstanding at December 31, 2008 and December 31, 2007,
respectively 43,381 42,785 Common stock warrants 13,742,630
15,551,492 Accumulated other comprehensive (loss) income 111,450
106,480 Additional paid-in capital 243,825,057 240,634,018
Accumulated deficit �
(227,296,216) �
(214,134,973) Total stockholders' equity �
30,426,302 �
42,199,802 Total liabilities
and stockholders' equity
$
36,232,955
$
53,934,211
�
INHIBITEX, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(unaudited)
� �
Three Months Ended Twelve Months Ended
December 31, December 31, 2008 �
2007
2008 �
2007 Revenue: License fees and milestones $
412,500 $ 412,500 $ 1,650,000 $ 1,650,000 Collaborative research
and development 375,000
375,000
1,500,000
1,125,000
Grants and other revenue � - � - � - � 28,500 Total revenue 787,500
787,500 3,150,000 2,803,500 Operating expense:
Research and development
3,566,097 3,542,524 12,548,430 42,585,988
General and administrative
� 991,936 � 1,450,911 � 5,075,048 � 6,300,863 Total operating
expense � 4,558,033 � 4,993,435 � 17,623,478 � 48,886,851 Loss from
operations (3,770,533) (4,205,935) (14,473,478) (46,083,351)
Other income (expense), net
68,094 24,668 87,651 1,969,216 Interest income, net � 153,402 �
656,763 � 1,224,584 � 2,654,753
Net loss
$ (3,549,037)
$
(3,524,504)
$ (13,161,243)
$
(41,459,382)
�
Basic and diluted net loss per
Share
$ (0.08) $
(0.08) $ (0.31)
$ (1.22) � Weighted average shares used
to compute basic and diluted net loss per share � 43,379,164 �
42,504,849 � 43,090,432 � 34,026,250 �
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