Inhibitex, Inc. (NASDAQ:INHX) today announced its financial
results for the fourth quarter and year ended December 31, 2010,
and provided an update on recent clinical and corporate
developments.
“We are very pleased with the progress we have made over the
past year in advancing our antiviral pipeline, which culminated in
establishing clinical proof of concept for both FV-100, which we
are developing to treat shingles, and more recently, INX-189, which
we are developing to treat chronic infections caused by hepatitis C
virus,” stated Russell H. Plumb, President and CEO of Inhibitex,
Inc. “Looking ahead in 2011, we expect to complete our Phase 1b
trial of INX-189 in the near-term and are developing plans to
further evaluate its safety and antiviral activity in a Phase 2
program that we estimate could begin in the third quarter of 2011.
Further, over the next several months we anticipate completing our
evaluation of the potential clinical and regulatory pathways and
commercial opportunities for FV-100, and look forward to
determining the possible next steps in its development.”
Clinical Development Highlights
- INX-189: Earlier this quarter, the
Company announced favorable interim results from a Phase 1b study
of INX-189 in HCV genotype 1 patients where INX-189, its nucleotide
polymerase inhibitor, demonstrated a clinically meaningful
antiviral effect (>1 log10 IU/mL reduction in baseline viral
load) in seven days of monotherapy at a relatively low (25mg)
once-daily dose.
- FV-100: In December 2010, the Company
successfully completed a first-in-patient, Phase 2 clinical trial
in shingles patients where a once-daily dose of 400mg FV-100
demonstrated the potential to reduce both the sub-acute pain and
the incidence of post herpetic neuralgia (PHN) associated with
shingles infections.
Fourth Quarter 2010 Financial Results
As of December 31, 2010, the Company held $19.6 million in cash,
cash equivalents and short-term investments.
The Company reported a net loss for the fourth quarter of 2010
of $7.0 million, as compared to a net loss of $4.7 million in the
fourth quarter of 2009. The $2.3 million increase in net loss in
the fourth quarter of 2010 was primarily the result of higher
research and development expense, and to a lesser extent, higher
general and administrative expense and lower net interest income,
offset in part by an increase in other income. Basic and diluted
net loss per share was $0.11 for the fourth quarter of 2010
compared to $0.08 for the fourth quarter of 2009. The increase in
net loss per share in the fourth quarter of 2010, as compared to
the fourth quarter of 2009, was due to the higher net loss, offset
in part by an increase in the weighted average number of shares
outstanding.
Research and development expense increased to $6.6 million in
the fourth quarter of 2010 from $4.3 million in the fourth quarter
of 2009. This $2.3 million increase was primarily due to a $1.7
million increase in direct costs incurred in connection with the
initiation of a Phase 1b clinical trial of INX-189 in November of
2010 and to a lesser extent, the completion of a Phase 2 clinical
trial of FV-100 in the December of 2010, as well as an increase of
$0.6 million in non-direct expenses associated with higher
consulting and professional fees and compensation and share-based
compensation expense.
General and administrative expense increased to $1.2 million in
the fourth quarter of 2010 from $0.7 million in the fourth quarter
of 2009. The increase of $0.5 million was primarily the result of
an increase in legal and professional fees and compensation and
share-based compensation expense.
Other income increased to $0.5 million in the fourth quarter of
2010 from zero in the fourth quarter of 2009 due to the receipt of
$0.5 million Therapeutic Tax Credit grant in the fourth quarter of
2010 that was not received in 2009.
Year End 2010 Financial Results
For the year ended December 31, 2010, the Company reported a net
loss of $22.7 million, as compared to $17.6 million for 2009. Basic
and diluted net loss per share for the year ended December 31,
2010, was $0.37, as compared to $0.38 for 2009. The $5.1 million
increase in net loss in 2010 was primarily the result of higher
research and development expense associated with a Phase 2 clinical
trial of FV-100, the initiation of a Phase 1 clinical program for
INX-189 in mid-2010 and an increase in other non-direct research
and development costs, as well as higher general and administrative
expense and lower net interest income, offset in part by higher
revenues from a collaborative license and development agreement and
net other income. The slight decrease in net loss per share in 2010
was due to an increase in the weighted average number of shares
outstanding, offset by the higher net loss.
Revenue increased to $1.9 million in 2010 from $1.2 million in
2009 due to the receipt of a $0.7 million milestone payment in the
first quarter of 2010 that did not occur in 2009.
Research and development expense increased to $21.0 million in
2010 from $15.4 million in 2009, primarily due to a $4.9 million
increase in direct costs incurred in connection with a Phase 2
clinical trial of FV-100 that was conducted throughout 2010 and the
initiation of a Phase 1 clinical program of INX-189 in mid-2010, as
well as an increase of $0.7 million in non-direct expenses
associated with higher consulting and professional fees and
compensation and share-based compensation expense.
General and administrative expense increased to $4.1 million in
2010 from $3.6 million in 2009. The increase of $0.5 million was
primarily the result of an increase in legal and professional fees
and compensation and share-based compensation expense incurred in
the fourth quarter of 2010.
Other income increased to $0.5 million in 2010 from zero in 2009
due to the receipt of $0.5 million Therapeutic Tax Credit grant in
the fourth quarter of 2010 that was not received in 2009.
Recent Corporate Developments
INX-189 for Chronic Hepatitis C – In January 2011, the
Company reported favorable preliminary interim safety and antiviral
data from the first two monotherapy cohorts of its ongoing Phase 1b
clinical trial of INX-189. The Company reported that INX-189, dosed
once-daily at 9mg and 25mg for seven days, demonstrated potent
antiviral activity with a mean HCV RNA reduction from baseline
levels of -0.71 and -1.03 log10 IU/mL, respectively. In addition to
the mean reductions in viral load, clinically meaningful decreases
in alanine transaminase (ALT) levels were observed for patients
receiving INX-189 at both dose levels, and no patients experienced
viral breakthrough. There were no serious adverse events reported,
no discontinuations due to an adverse event, and no adverse events
related to changes in clinical laboratory evaluations. All reported
adverse events were mild or moderate and were not dose dependent.
In addition, the pharmacokinetics of the 9mg and 25mg doses in
HCV-infected patients were comparable to those observed in healthy
volunteers.
The Phase 1b 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 antiviral activity of INX-189, administered
orally once-daily for seven days in HCV genotype 1 treatment-naïve
patients. Each treatment cohort in the trial is comprised of 10
patients, eight that receive INX-189 and two that receive placebo.
In addition to the 9mg and 25mg dose cohorts, the Company will
enroll three more INX-189 monotherapy cohorts in the trial,
including a recently-added 100mg cohort, as well as two cohorts
that will receive 9mg and 25mg of INX-189 once daily for seven days
in combination with ribavirin. The Company anticipates completing
this ongoing Phase 1b trial around the end of the first quarter of
2011.
In February 2011, the Company reported that the U.S. Food and
Drug Administration (FDA) designated the investigation of INX-189
as a Fast Track development program. Fast Track programs are
designed to facilitate the development and expedite the review of
new drugs that are intended to treat serious or life threatening
conditions and that demonstrate the potential to address unmet
medical needs.
FV-100 for Shingles – In December 2010, the Company
reported top-line safety and efficacy data from its Phase 2
clinical trial of FV-100, an oral antiviral compound being
developed to treat shingles, including the reduction of
shingles-associated pain and the incidence of PHN. The study
included 350 shingles patients and compared two once-daily doses of
FV-100 (200mg and 400mg) to valacyclovir, one of the most
commonly-used antiviral drugs to treat shingles. Valacyclovir was
administered three times per day at 1,000 mg per dose.
Numerically favorable treatment differences were observed for
both doses of FV-100 as compared to valacyclovir for the primary
endpoint of the study, defined as the reduction in the severity and
duration of shingles-associated acute pain over the first 30 days,
or the Burden of Illness (BOI30 AUC), although these treatment
differences were not statistically significant. There were also
numerically favorable treatment differences observed for key
secondary pain endpoints, including a 14% relative reduction in the
severity and duration of shingles-associated pain over 90 days
(BOI90 AUC) and a 39% relative reduction in the incidence of PHN
for the 400mg dose of FV-100. The trial was not powered to
demonstrate statistically significant treatment differences between
the arms with respect to these and other secondary endpoints.
FV-100 was generally well tolerated at both dose levels, and
demonstrated a similar adverse event profile as compared to
valacyclovir. All three treatment arms showed a relatively low
proportion of adverse and serious adverse events. The Company is
currently performing various analyses of the full Phase 2 data set
and an evaluation of various clinical, regulatory and commercial
pathways for the potential future development of FV-100, which it
anticipates concluding in the first half of 2011.
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 and year-end 2010 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 March 11 until April 11, 2011, 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 # 366809. 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 HCV and INX-189
Chronic hepatitis C is a disease of the liver caused by HCV,
which can result in cirrhosis and cancer, and is the leading reason
for 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 one of the most potent HCV nucleotide polymerase
inhibitor currently in clinical development, and that results from
preclinical studies and its Phase 1 trials of INX-189 to-date
support its potential as a once-daily oral antiviral therapy
amenable to fixed-dose combination with other antivirals for the
treatment of patients with chronic hepatitis C infections.
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 antiviral agent
currently approved for the treatment of shingles. Inhibitex
believes these characteristics, a favorable pharmacokinetic
profile, and the results of a recently-completed Phase 2 trial
support the potential of FV-100 as a once-daily oral therapy to
reduce the incidence, severity and duration of shingles-associated
pain and PHN.
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, INX-189
and FV-100, 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 a staphylococcal vaccine, which is currently being
evaluated in Phase 1 clinical trials.
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 it will take
the Company to conclude its assessment of the FV-100 Phase 2 data
and the compound’s potential clinical, regulatory and commercial
pathways; the potential for FV-100 to be dosed once daily and
reduce the incidence, severity and duration of shingles-associated
pain and PHN; the Company plans to enroll additional cohorts in the
ongoing Phase 1b trial of INX-189; the time frame in which a Phase
2 clinical program of INX-189 can be initiated; the Company’s
belief that INX-189 is one of the most potent HCV nucleotide
polymerase inhibitor currently in clinical development; the results
of preclinical studies and the Phase 1 trials of INX-189 to-date
supporting its potential as a once-daily oral antiviral amenable to
fixed dose combination with other antivirals; and the anticipated
time when the ongoing Phase 1b trial of INX-189 will be completed,
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, antiviral
activity, commercial viability, or any other reason; FV-100 not
demonstrating sufficient activity or potential in reducing the
incidence and severity of shingles-related pain and PHN, to be
clinically relevant or commercially viable; the Company or its
clinical investigators not being able to enroll additional HCV
patients in the Phase 1b trial on a timely basis; 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, June 30, 2010, and
September 30, 2010, as filed with the SEC on May 13, 2010, August
12, 2010, and November 15, 2010, 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, 2010
2009 ASSETS Current assets: Cash and cash equivalents
$ 8,554,151 $ 11,290,332 Short-term investments 11,014,747
26,625,496 Prepaid expenses and other current assets 599,042
831,196 Accounts receivable
178,654
61,062 Total current assets 20,346,594
38,808,086 Property and equipment, net. 1,090,029 1,621,392 Other
long-term assets
52,514
40,290 Total assets
$
21,489,137 $
40,469,768 LIABILITIES AND
STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $
2,768,020 $ 1,590,804 Accrued expenses 2,917,347 1,537,637 Current
portion of notes payable 243,056 78,125 Current portion of capital
lease obligations 180,792 207,100 Current portion of deferred
revenue 129,167 191,667 Other current liabilities
238,703 202,531
Total current liabilities 6,477,085 3,807,864 Long-term
liabilities: Notes payable, net of current portion 303,819 546,875
Capital lease obligations, net of current portion — 180,792
Deferred revenue, net of current portion — 87,500 Other
liabilities, net of current portion
867,455
1,096,629 Total long-term
liabilities
1,171,274
1,911,796 Total liabilities 7,648,359 5,719,660
Stockholders' equity: Preferred stock, $.001 par value; 5,000,000
shares authorized at December 31, 2010 and December 31, 2009; none
issued and outstanding — — Common stock, $.001 par value;
150,000,000 shares authorized at December 31, 2010 and December 31,
2009, respectively; 62,423,358 and 61,559,782 shares issued and
outstanding at December 31, 2010 and December 31, 2009,
respectively 62,423 61,560 Common stock warrants 11,145,558
12,133,216 Accumulated other comprehensive income 542 8,977
Additional paid-in capital 270,187,742 267,432,572 Accumulated
deficit
(267,555,487 )
(244,886,217 ) Total stockholders' equity
13,840,778 34,750,108
Total liabilities and stockholders' equity
$
21,489,137
$
40,469,768
INHIBITEX, INC.
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
(unaudited)
Three Months Ended Twelve Months Ended
December 31, December 31, 2010 2009
2010 2009 Revenue: License fees and milestones $
37,500 $ 37,500 $ 861,667 $ 150,000 Collaborative research and
development 250,000 250,000 1,000,000 1,000,000 Grants and other
revenue - - - -
Total revenue 287,500 287,500 1,861,667 1,150,000 Operating
expense:
Research and development
6,634,226 4,269,994 21,040,727 15,393,066
General and administrative
1,199,623 711,574 4,059,675
3,551,682 Total operating expense
7,833,849 4,981,568 25,100,402
18,944,748 Loss from operations (7,546,349 )
(4,694,068 ) (23,238,735 ) (17,794,748 ) Other income (expense) ,
net 489,466 (3,099 ) 504,073 36,535 Interest income, net
13,018 3,844 65,392
168,212
Net loss
$ (7,043,865 ) $ (4,693,323 ) $ (22,669,270 ) $ (17,590,001 )
Basic and diluted net loss per
Share
$ (0.11 ) $
(0.08 ) $ (0.37
) $ (0.38 )
Weighted average shares used to compute basic and diluted
net loss per share 62,351,121 56,056,996
62,001,757 46,664,811
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