Inhibitex, Inc. (NASDAQ:INHX) today announced its financial
results for the first quarter ended March 31, 2011 and provided an
update on recent clinical and corporate developments.
“Over the last few months we have achieved several important
milestones and objectives,” stated Russell H. Plumb, President and
CEO of Inhibitex, Inc. “We believe the positive safety and
antiviral results of our Phase 1b study of INX-189 support
advancing it into Phase 2 studies, which we plan to initiate in the
third quarter of 2011. Further, our recently-completed financing
provides us with additional strategic flexibility and the capital
resources to support the progress of INX-189 through these planned
Phase 2 studies.”
Recent Highlights
- Reported positive top-line safety and
antiviral data from a multiple ascending dose Phase 1b clinical
trial of INX-189, a nucleotide polymerase inhibitor in development
to treat chronic hepatitis C infection
- The FDA granted INX-189 “Fast Track”
status
- The completion of a $54 million public
offering
Near-Term 2011Goals
- Initiate a Phase 2 clinical development
program for INX-189 in HCV genotype 1, 2 and 3 patients that
demonstrates the compound’s potent pan-genotypic antiviral activity
and high genetic barrier to resistance in combination therapy
- Nominate a second HCV nucleotide
polymerase inhibitor for advancement into IND-enabling preclinical
development in the second half of 2011
- Complete the ongoing strategic review
of and finalize potential developmental plans for FV-100 in
mid-2011
Recent Corporate Developments
INX-189 for Chronic Hepatitis C: In March 2011, the Company
announced positive top-line safety and antiviral data from its
multiple ascending dose Phase 1b clinical trial of INX-189, an oral
nucleotide polymerase inhibitor being developed to treat chronic
infections caused by hepatitis C virus (HCV). INX-189, dosed
once-daily at 9, 25, 50 and 100 mg for seven days, demonstrated
potent and 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 median HCV RNA decline from baseline
observed in patients that received placebo was -0.20 log10 IU/mL.
Further, INX-189, dosed once-daily in combination with ribavirin
for seven days at 9 mg and 25 mg resulted in median HCV RNA
reductions from baseline of -0.75 and -1.56 log10 IU/mL,
respectively. The median HCV RNA change from baseline observed in
patients that received placebo and ribavirin was +0.04 log10 IU/mL.
In addition, data from the Phase 1b study indicate that (i) no
patients experienced viral breakthrough, (ii) INX-189 was generally
well tolerated, and (iii) clinically meaningful decreases in
alanine transaminase (ALT) levels were observed for patients
receiving INX-189.
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. Under the FDA Modernization
Act of 1997, 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.
Public Offering: In April 2011, the Company announced it had
completed a public offering of 13,182,927 shares of its common
stock, at a purchase price of $4.10 per share, for an aggregate
offering amount of $54 million. The net proceeds to the
Company, after underwriting discounts and commissions and other
offering expenses, were approximately $50.6 million.
First Quarter 2011 Financial Results
As of March 31, 2011, the Company held $13.0 million in cash,
cash equivalents and short-term investments. This amount does not
include $50.6 million in net proceeds from the public offering that
closed on April 12, 2011.
The Company reported a net loss for the first quarter of 2011 of
$7.5 million, as compared to a net loss of $4.8 million in the
first quarter of 2010. The $2.7 million increase in net loss in the
first quarter of 2011 was primarily the result of higher research
and development expense and lower revenues, and to a lesser extent,
higher general and administrative expense and lower net interest
income. Basic and diluted net loss per share was $0.12 for the
first quarter of 2011 as compared to $0.08 for the first quarter of
2010.
Revenue decreased to $0.3 million in the first quarter of 2011
from $1.0 million in the first quarter of 2010 as a result of a
$0.7 million milestone payment earned by the Company in the first
quarter of 2010 that did not recur in the first quarter of
2011.
Research and development expense increased to $6.6 million in
the first quarter of 2011 from $4.8 million in the first quarter of
2010. The $1.8 million increase was due to a $2.1 million increase
in direct costs incurred in connection with the Phase 1b clinical
trial of INX-189 and a net increase of $0.1 million in non-direct
expenses, offset in part by a decrease of $0.4 million in direct
costs associated with the completion of the Phase 2 clinical
program of FV-100.
General and administrative expense increased to $1.2 million in
the first quarter of 2011 from $1.0 million in the first quarter of
2010. The increase of $0.2 million was the result of an increase in
salaries, benefits and share-based compensation expense as well as
market research expenses related to the FV-100 program.
Financial Guidance
Based upon the $13.0 million in cash, cash equivalents and
short-term investments on hand as of March 31, 2011, and the $50.6
million in net proceeds from its recently-completed public
offering, the Company currently anticipates that it has sufficient
financial resources to support its planned operations into the
first quarter of 2013. This estimate does not include the impact of
any additional financing or other significant transactions,
milestone payments, license fees or a change in strategy or
clinical development plans in the future.
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 first quarter 2011 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, 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 May 6, 2011 until June 6, 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 # 371739. 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 pipeline includes FV-100, which is in Phase
2 clinical development for the treatment of shingles, and INX-189,
a nucleotide polymerase inhibitor in Phase 1b clinical development
for the treatment of chronic hepatitis C infections. 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
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’s belief that the
positive safety and antiviral results of its Phase 1b study of
INX-189 support advancing it into Phase 2 studies; the time frame
in which a Phase 2 clinical program of INX-189 can be initiated and
the nature and extent of the contemplated studies; the Company’s
plans to nominate a second HCV nucleotide polymerase inhibitor for
advancement into IND-enabling preclinical development in the second
half of 2011; the anticipated time frame in which the Company plans
to conclude its strategic review of the FV-100 program and finalize
potential developmental plans for FV-100; the Company’s belief that
its recently-completed financing provides additional strategic
flexibility and capital resources to support the progress of
INX-189 through planned Phase 2 studies; and the Company’s belief
that it has sufficient financial resources to support its planned
operations into the first quarter of 2013, 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, limiting, suspending
or terminating the clinical development of FV-100 or INX-189 at any
time for a lack of safety, tolerability, anti-viral activity,
commercial viability, regulatory issues, or any other reason;
FV-100 not demonstrating sufficient activity or potential in
reducing the incidence and severity of shingles-related sub-acute
pain or PHN to be clinically relevant or commercially viable; the
Company not being able to identify and nominate an additional HCV
nucleotide polymerase to enter IND-enabling preclinical studies on
a timely basis, if at all; obtaining, maintaining and protecting
the intellectual property incorporated into and supporting the
commercial viability of the Company’s product candidates; the
Company not maintaining expenses, revenues and other cash
expenditures substantially in line with planned or anticipated
levels and other cautionary statements contained elsewhere herein
and in its Annual Report on Form 10-K for the year ended December
31, 2010, as filed with the Securities and Exchange Commission, or
SEC, on March 16, 2011. 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, 2011
2010 ASSETS Current
assets: Cash and cash equivalents $ 10,036,760 $ 8,554,151
Short-term investments 3,001,485 11,014,747 Prepaid expenses and
other current assets 365,973 599,042 Accounts receivable
82,730 178,654 Total
current assets 13,486,948 20,346,594 Property and equipment, net.
915,074 1,090,029 Other long-term assets
85,395
52,514 Total assets
$ 14,487,417 $
21,489,137 LIABILITIES AND
STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $
1,795,289 $ 2,768,020 Accrued expenses 3,656,534 2,917,347 Current
portion of notes payable 243,056 243,056 Current portion of capital
lease obligations 125,335 180,792 Current portion of deferred
revenue 341,667 129,167 Other current liabilities
432,941 238,703
Total current liabilities 6,594,822 6,477,085 Long-term
liabilities: Notes payable, net of current portion 243,055 303,819
Other liabilities, net of current portion
802,698 867,455
Total long-term liabilities
1,045,753
1,171,274 Total liabilities 7,640,575
7,648,359 Stockholders' equity: Preferred stock, $.001 par value;
5,000,000 shares authorized at March 31, 2011 and December 31,
2010; none issued and outstanding — — Common stock, $.001 par
value; 150,000,000 shares authorized at March 31, 2011 and December
31, 2010, respectively; 62,439,215 and 62,423,358 shares issued and
outstanding at March 31, 2011 and December 31, 2010, respectively
62,439 62,423 Common stock warrants 11,145,558 11,145,558
Accumulated other comprehensive (loss) income 1,081 542 Additional
paid-in capital 270,663,911 270,187,742 Accumulated deficit
(275,026,147 )
(267,555,487 )
Total stockholders' equity
6,846,842
13,840,778 Total liabilities and
stockholders' equity
$
14,487,417
$
21,489,137
INHIBITEX, INC.
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
(unaudited)
Three Months Ended March 31,
2011 2010 Revenue:
License fees and milestones $ 37,500 $ 749,167 Collaborative
research and development 250,000 250,000
Total revenue 287,500 999,167 Operating expense: Research
and development 6,572,810 4,789,615 General and administrative
1,197,183 1,024,041 Total operating
expense 7,769,993 5,813,656 Loss from
operations (7,482,493 ) (4,814,489 ) Other income, net 8,638 3,520
Interest income, net 3,195 17,816
Net loss
$
(7,470,660
)
$
(4,793,153
)
Basic and diluted net loss per share
$ (0.12 ) $
(0.08 )
Weighted average shares used to compute
basic and diluted net loss per share
62,437,220 61,561,030
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