Inhibitex, Inc. (NASDAQ:INHX, the “Company”) today announced its
financial results for the third quarter ended September 30, 2011
and provided an update on several recent corporate developments,
including top-line safety and antiviral data from the first cohort
in its ongoing clinical trial designed to evaluate higher doses of
INX-189, an oral nucleotide polymerase inhibitor, being developed
to treat chronic infections caused by hepatitis C virus (HCV),
administered as monotherapy or in combination with ribavirin for
seven days.
“We are very pleased with the progress we have made in the
clinical development of INX-189 over the past several months, as
well as the continued potent, dose-dependent antiviral activity it
is demonstrating as monotherapy in genotype 1 treatment-naïve HCV
patients,” stated Russell H. Plumb, President and CEO of Inhibitex,
Inc. “We look forward to expanding the scope of our Phase 2 program
to include interferon-free combinations of INX-189 with other
antiviral agents in HCV genotype 1, 2, and 3 patients in 2012.”
Recent Corporate Developments
INX-189 for Chronic Hepatitis C – The Company today
reported top-line safety and antiviral data from the first cohort
of its ongoing clinical trial of INX-189, which is primarily
designed to further evaluate the safety, tolerability,
pharmacokinetics and antiviral activity of higher doses of INX-189,
administered as monotherapy, or in combination with ribavirin, for
seven days in treatment-naïve patients with chronic HCV genotype 1.
In this study, 200 mg INX-189, dosed once-daily for seven days,
continued to demonstrate potent and dose-dependent antiviral
activity with a median HCV RNA reduction from baseline of -4.25
log10 IU/mL. Further, 200 mg INX-189 was generally well tolerated,
and there were no serious adverse events (SAE) or dose dependent
adverse events (AE) observed.
In September, the Company announced the initiation of this
trial, which includes other planned cohorts of 100 mg INX-189 dosed
once daily in combination with ribavirin, 100 mg INX-189 dosed
twice daily as monotherapy, 100 mg INX-189 dosed with food, and
possibly higher monotherapy doses of INX-189. Earlier this year,
the Company reported positive top-line safety and antiviral data
from its initial multiple ascending dose Phase 1b clinical trial of
INX-189, whereby INX-189, when dosed once-daily at 9 mg, 25 mg, 50
mg and 100 mg for seven days, demonstrated dose-dependent antiviral
activity with median HCV RNA reductions from baseline of -0.64,
-1.00, -1.47, and -2.53 log10 IU/mL, respectively.
The Company also reported today that it has initiated a Phase 1
drug/drug interaction study in healthy volunteers of INX-189 and an
HCV direct acting antiviral compound, the objective of which is to
evaluate the safety, tolerability and pharmacokinetics of the two
compounds in contemplation of the Company expanding its Phase 2
clinical development program to include interferon-free
combinations of INX-189 with other antiviral agents in HCV genotype
1, 2, and 3 patients in 2012. The Company anticipates that this
study will be completed by year-end.
In September, the Company also announced the commencement of a
90-patient randomized, placebo controlled, response-guided, Phase 2
clinical trial to evaluate the safety, tolerability and antiviral
activity of INX-189 in combination with pegylated interferon and
ribavirin in chronic HCV-infected genotype 2 and 3 treatment-naïve
patients. This ongoing clinical trial is designed to evaluate three
once-daily doses of INX-189 (25 mg, 50 mg and 100 mg) administered
in combination with pegylated interferon and ribavirin for 12
weeks, and includes a control arm in which patients will receive
placebo and standard of care treatment (a combination of pegylated
interferon and ribavirin for 24 weeks). Each INX-189 combination
treatment cohort in the trial is expected to include 25 patients,
and the control arm is expected to include 15 patients. Patients in
the INX-189 containing treatment arms that achieve an extended
rapid viral response, or eRVR, defined as having HCV RNA below the
level of detection after 28 days and 12 weeks of dosing, will stop
all therapy after 12 weeks. Those patients who do not achieve an
eRVR will continue receiving pegylated interferon and ribavirin for
12 additional weeks. Patients will be followed for 24 weeks after
end-of-treatment to determine if they achieve a sustained viral
response (SVR), which is the currently accepted definition of cure
for chronic HCV infections. The Company anticipates completing
enrollment in this trial around year end.
The Company is presenting two abstracts at the upcoming annual
meeting of the American Association for the Study of Liver Diseases
(AASLD) in San Francisco beginning November 4, 2011. On
August 2, 2011, AASLD posted the titles of these abstracts on
its website, which are:
- Antiviral Activity and Safety of
INX-08189, a Nucleotide Polymerase Inhibitor, Following 7-Days of
Oral Therapy in Naïve Genotype-1 Chronic HCV Patients
- Preclinical Characterization of a
Series of Highly Potent Phosphorodiamidate Nucleotide Analogue
Inhibitors of Hepatitis C Polymerase.
FV-100 – In August, the Company announced its intentions to file
a protocol and other associated submissions, including a patient
reported outcomes (PRO) dossier, to the FDA for a proposed Phase 2b
trial of FV-100 in order to obtain feedback on the protocol, its
PRO methodology, and a regulatory pathway that could potentially
support an indication for the reduction of shingles-associated pain
and/or the incidence of post-herpetic neuralgia (PHN). The Company
anticipates submitting these documents to the FDA this month.
Subject to satisfactory regulatory review and feedback concerning
the proposed clinical endpoints and the potential to support an
indication for the reduction of shingles-associated pain and/or
incidence of PHN, the Company will determine whether it will
initiate the proposed Phase 2b study of FV-100 in 2012.
Third Quarter 2011 Financial Results
As of September 30, 2011, the Company held $53.7 million in
cash, cash equivalents, short-term and long-term investments.
The Company reported a net loss in the third quarter of 2011 of
$5.3 million, which was the same net loss it reported in the third
quarter of 2010. While the net loss in each of these quarters was
essentially the same, the net loss in the third quarter of 2011
resulted from an increase in milestone revenue earned in the
quarter that was offset by higher research and development expense.
Basic and diluted net loss per share was $0.07 for the third
quarter of 2011, as compared to $0.08 for the third quarter of
2010.
Revenue for the third quarter of 2011 increased to $1.3 million
from $0.3 million in the third quarter of 2010 due to a $1.0
million milestone earned and received from our licensee and
collaborator, Pfizer, Inc. associated with the initiation of a
Phase 1/ 2 clinical trial of a 4-antigen Staphylococcus aureus (S.
aureus) vaccine (SA4Ag) during the quarter.
Research and development expense increased to $5.7 million in
the third quarter of 2011 from $4.7 million in the third quarter of
2010. The $1.0 million increase was primarily due to a $0.4 million
increase in direct costs incurred with the initiation of both the
Phase 2 genotype 2/3 clinical trial of INX-189 and the additional
clinical trial of INX-189 designed to evaluate higher doses of
INX-189 administered as monotherapy or in combination with
ribavirin for seven days, as well as an increase in non-direct
expenses of $0.6 million related to an increase in research and
development personnel and higher use of laboratory supplies.
General and administrative expense was $0.9 million in the third
quarter of 2011, which was the same amount as reported in the third
quarter of 2010.
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 2011 operating results and financial
position, as well as provide a general update on recent corporate
developments 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 November 4, 2011 until December 4,
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 # 382037. 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 Inhibitex
Inhibitex, Inc. is a biopharmaceutical company focused on
developing products to prevent and treat serious infectious
diseases. The Company’s clinical-stage pipeline includes two Phase
2 development programs for which it has retained all future rights:
INX-189, a nucleotide polymerase inhibitor in development for the
treatment of chronic hepatitis C infections and FV-100, a
nucleotide polymerase inhibitor in development for the treatment of
shingles-associated pain. The Company also has additional HCV
nucleotide polymerase inhibitors in preclinical development and has
licensed the use of its proprietary MSCRAMM® protein platform to
Pfizer for the development of a staphylococcal vaccine, which is
currently being evaluated in a Phase 1/2 clinical trial. 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’s plan to evaluate the
safety, tolerability, pharmacokinetics and antiviral activity of
additional doses of INX-189 administered as monotherapy or in
combination with ribavirin for seven days in its ongoing trial; the
Company’s plan to expand the scope of its Phase 2 development
program of INX-189 to include interferon-free combinations in HCV
genotype 1, 2, and 3 patients in 2012; the time in which the
Company anticipates completing an ongoing drug/drug interaction
study in healthy subjects; the time in which the Company
anticipates completing enrollment in its ongoing Phase 2 clinical
trial, and; the Company’s intention to file a protocol for a Phase
2b clinical trial of FV-100 and other related submissions to the
FDA this month and obtain feedback from the agency prior to
determining whether it will initiate the proposed Phase 2b study of
FV-100 in 2012, 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, Pfizer, the FDA,
a data safety monitoring board, or an institutional review board
(IRB) delaying, limiting, suspending or terminating the clinical
development of INX-189, FV-100, or the staphylococcal vaccine at
any time for a lack of safety, tolerability, biologic activity or
efficacy, commercial viability, regulatory issues, or any other
reason; the Company’s ability to secure and use qualified
third-party clinical and preclinical research and data management
organizations to assist it in initiating and conducting planned
clinical trials and preclinical studies; third party contract
manufacturers not fulfilling their contractual obligations or
otherwise performing satisfactorily in the future; the Company’s
ability to manufacture and maintain sufficient quantities of
preclinical and clinical trial material on-hand to complete planned
preclinical studies and clinical trials on a timely basis; and
other cautionary statements contained elsewhere herein and in its
Annual Report on Form 10-K for the year ended December 31, 2010 and
its Quarterly Report on Form 10-Q for the period ended March 31,
2011 and June 30, 2011,as filed with the Securities and Exchange
Commission, or SEC, on March 16, 2011, May 6, 2011 and August 9,
2011, 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. VictrelisTM is a trademark of Schering Corp., a subsidiary of
Merck & Co. Inc.
INHIBITEX, INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(unaudited)
September 30,
December 31, 2011 2010 ASSETS
Current assets: Cash and cash equivalents $ 15,985,299 $ 8,554,151
Short-term investments 36,702,869 11,014,747 Prepaid expenses and
other current assets 1,380,336 599,042 Accounts receivable
105,402 178,654
Total current assets 54,173,906 20,346,594
Property and equipment, net
687,734 1,090,029 Long-term investments 999,870
--
Other long-term assets
78,740
52,514 Total assets
$
55,940,250 $
21,489,137 LIABILITIES AND
STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $
2,649,345 $ 2,768,020 Accrued expenses 2,537,305 2,917,347 Current
portion of notes payable 243,056 243,056 Capital lease obligations
22,113 180,792 Deferred revenue 41,667 129,167 Other current
liabilities
258,382
238,703 Total current liabilities 5,751,868
6,477,085 Long-term liabilities: Notes payable, net of current
portion 121,527 303,819 Other liabilities, net of current portion
688,830 867,455
Total long-term liabilities
810,357
1,171,274 Total liabilities
6,562,225 7,648,359 Stockholders' equity: Preferred stock, $.001
par value; 5,000,000 shares authorized at September 30, 2011 and
December 31, 2010; none issued and outstanding
--
--
Common stock, $.001 par value; 150,000,000 shares authorized at
September 30, 2011 and December 31, 2010, respectively; 78,286,957
and 62,423,358 shares issued and outstanding at September 30, 2011
and December 31, 2010, respectively 78,287 62,423 Common stock
warrants 8,309,413 11,145,558 Accumulated other comprehensive
(loss) income (33,006 ) 542 Additional paid-in capital 326,584,914
270,187,742 Accumulated deficit
(285,561,583 )
(267,555,487 ) Total stockholders' equity
49,378,025
13,840,778 Total liabilities and stockholders'
equity
$
55,940,250
$
21,489,137
INHIBITEX, INC.
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
(unaudited)
Three Months Ended Nine
Months Ended September 30, September 30,
2011 2010 2011 2010
Revenue: License fees and milestones $ 1,012,500 $ 37,500 $
1,087,500 $ 824,167 Collaborative research and development
250,000 250,000 750,000
750,000 Total revenue 1,262,500 287,500 1,837,500 1,574,167
Operating expense:
Research and development
5,675,394 4,700,987 16,847,529 14,406,501
General and administrative
888,887 877,177 3,051,202
2,860,052 Total operating expense 6,564,281
5,578,164 19,898,731
17,266,553 Loss from operations (5,301,781 ) (5,290,664 )
(18,061,231 ) (15,692,386 ) Other (expense) income, net (7,118 )
(1,107 ) 1,484 14,607 Interest income, net 32,434
18,309 53,651 52,374
Net loss
$ (5,276,465 ) $ (5,273,462 ) $ (18,006,096 ) $ (15,625,405 )
Basic and diluted net loss per Share
$ (0.07 ) $
(0.08 ) $ (0.25
) $ (0.25 )
Weighted average shares used to compute basic and diluted
net loss per share 78,119,694 62,248,265
71,933,556 61,884,023
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