The information in this
preliminary prospectus supplement is not complete and may be
changed. This preliminary prospectus supplement and the
accompanying prospectus are not an offer to sell securities and
are not soliciting an offer to buy these securities in any
jurisdiction where the offer or sale is not permitted.
Filed
Pursuant to Rule 424(b)(5)
Registration
No. 333-165786
SUBJECT TO COMPLETION, DATED
APRIL 6, 2011
PRELIMINARY
PROSPECTUS SUPPLEMENT
(To Prospectus dated May 6,
2010)
Inhibitex, Inc.
Shares
Common Stock
We are offering up
to shares
of our common stock, $.001 par value per share. Our common
stock is listed on the Nasdaq Capital Market under the symbol
INHX. On April 5, 2011, the last reported sale price
of our common stock on the Nasdaq Capital Market was $4.95 per
share.
Investing in our securities involves a high degree of risk.
See Risk Factors beginning on
page S-7
of this prospectus supplement.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or passed upon the adequacy or accuracy of this
prospectus supplement or the accompanying prospectus. Any
representation to the contrary is a criminal offense.
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Per Share
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Total
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Public offering price
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$
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$
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Underwriting discounts and commissions
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$
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$
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Proceeds, before expenses, to us
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We have granted the underwriters a
30-day
option to purchase, on the same terms and conditions set forth
below, a maximum
of
additional shares of common stock solely to cover
over-allotments.
Delivery of the shares of our common stock offered hereby is
expected to be made on or about April , 2011.
Sole Book-Running Manager
Deutsche Bank
Securities
The date of this prospectus supplement is
April , 2011.
TABLE OF
CONTENTS
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Page No.
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Prospectus Supplement
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S-1
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S-2
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S-3
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S-7
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S-27
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S-28
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S-29
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S-31
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S-31
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S-31
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S-31
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Prospectus Dated May 6, 2010
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You should rely only on the information contained in, or
incorporated by reference into, this prospectus supplement and
contained in, or incorporated by reference into, the
accompanying prospectus or any free writing prospectus, as
modified and superseded pursuant to Rule 412 under the
Securities Act of 1933, as amended, or the Securities Act. We
have not, and the underwriters have not, authorized anyone to
provide you with different information. No dealer, salesperson
or other person is authorized to give any information or to
represent anything not contained in this prospectus supplement
and the accompanying prospectus. You should not rely on any
unauthorized information or representation. This prospectus
supplement is an offer to sell only the securities being offered
hereby and only under circumstances and in jurisdictions where
it is lawful to do so. You should assume that the information in
this prospectus supplement, the accompanying prospectus and any
free writing prospectus is accurate only as of the date on the
front of the applicable document and that any information we
have incorporated by reference is accurate only as of the date
of the document incorporated by reference, regardless of the
time of delivery of this prospectus supplement, the accompanying
prospectus or any free writing prospectus, or any sale of a
security.
ABOUT
THIS PROSPECTUS SUPPLEMENT
This document is in two parts. The first part is the prospectus
supplement, including the documents incorporated by reference,
which describes the specific terms of this offering. The second
part, the accompanying prospectus, including the documents
incorporated by reference, provides more general information.
Generally, when we refer to this prospectus, we are
referring to both parts of this document combined. We urge you
to carefully read this prospectus supplement and the
accompanying prospectus, and the documents incorporated herein
and therein, before buying any of the securities being offered
under this prospectus supplement. This prospectus supplement may
add, update or change information contained in the accompanying
prospectus. If the information varies between this prospectus
supplement and the accompanying prospectus, you should rely on
the information contained in this prospectus supplement;
provided that if any statement in one of these documents is
inconsistent with a statement in another document having a later
date the statement in the document having the later date
modifies or supersedes the earlier statement in accordance with
Rule 412 under the Securities Act.
Market data and industry statistics used throughout this
prospectus supplement, the accompanying prospectus and the
documents incorporated by reference herein and therein are based
on independent industry publications, reports by market research
firms and other published independent sources. Although we
believe these sources are credible, we have not independently
verified the data or information obtained from these sources.
Accordingly, investors should not place undue reliance on this
information. By including such market data and information, we
do not undertake a duty to update or provide that data in the
future.
When used in this prospectus supplement and the accompanying
prospectus, the terms Inhibitex, we,
our and us refer to Inhibitex, Inc., a
Delaware corporation, and its subsidiaries, unless otherwise
specified or unless the context requires otherwise.
This prospectus supplement, the accompanying prospectus and the
information incorporated by reference herein and therein may
include trademarks, service marks and trade names owned by us or
other companies. All trademarks, service marks and trade names
included or incorporated by reference into this prospectus
supplement, the accompanying prospectus or any related free
writing prospectus are the property of their respective owners.
S-1
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus supplement, the accompanying prospectus and the
documents incorporated by reference into these documents contain
forward-looking statements within the meaning of
Section 27A of the Securities Act and Section 21E of
the Securities Exchange Act of 1934, as amended, or the Exchange
Act. Forward-looking statements deal with our current plans,
intentions, beliefs and expectations and statements of future
economic performance. Statements containing terms such as
believe, do not believe,
plan, expect, intend,
estimate, anticipate and other phrases
of similar meaning are considered to contain uncertainty and are
forward-looking statements. These forward-looking statements
include, without limitation, statements relating to:
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our ability to successfully advance the clinical development of
INX-189 and FV-100;
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the expected timing of future milestones and events, and our
development plans associated with INX-189 and FV-100 or any of
our product candidates;
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our ability to successfully execute our strategy;
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the timing and our plans to initiate a Phase 2 clinical trial
for INX-189 to further assess its safety, tolerability and
antiviral activity;
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the timing and our plans to nominate another hepatitis C
virus (HCV) nucleotide polymerase inhibitor for
advancement into investigational new drug application
(IND) enabling preclinical studies;
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the timing and our plans to complete a full evaluation of the
Phase 2 FV-100 data set and post hoc analyses, conduct
additional market research, including reimbursement, pricing,
and competitive analyses, etc., and develop our potential future
developmental plans for FV-100;
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our intent to establish strategic licenses, collaborations or
partnerships in the future to accelerate the development and
commercialization of our product candidates;
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the number of months that our current cash, cash equivalents,
and short-term investments will allow us to operate without
raising additional capital;
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potential future revenue from collaborative research agreements,
partnerships, license agreements or materials transfer
agreements; and
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our ability to generate product-related revenue in the future.
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In addition, from time to time we or our representatives have
made or will make forward-looking statements orally or in
writing. Furthermore, such forward-looking statements may be
included in various filings that we make with the Securities and
Exchange Commission (SEC) or press releases or oral
statements made by or with the approval of one of our authorized
executive officers. These forward-looking statements are subject
to certain known and unknown risks and uncertainties, as well as
assumptions that could cause actual results to differ materially
from those reflected in these forward-looking statements.
Factors that might cause actual results to differ include, but
are not limited to, those set forth under Risk
Factors, in our most recent Annual Report on
Form 10-K
and in our future filings made with the SEC. Readers are
cautioned not to place undue reliance on any forward-looking
statements contained herein, which reflect managements
opinions only as of the date hereof. Except as required by law,
Inhibitex undertakes no obligation to revise or publicly release
the results of any revisions to any forward-looking statements.
You are advised, however, to consult any additional disclosures
we have made or will make in our reports to the SEC on
Forms 10-K,
10-Q
and
8-K.
All
subsequent written and oral forward-looking statements
attributable to us or persons acting on our behalf are expressly
qualified in their entirety by the cautionary statements
contained in this prospectus supplement and the accompanying
prospectus.
S-2
PROSPECTUS
SUPPLEMENT SUMMARY
This summary highlights certain information about us, this
offering and information appearing elsewhere in this prospectus
supplement, in the accompanying prospectus and in the documents
we incorporate by reference. This summary is not complete and
does not contain all of the information that you should consider
before investing in our securities. You should read this entire
prospectus supplement and the accompanying prospectus carefully,
including the information referred to under the heading
Risk Factors in this prospectus supplement, and the
financial statements and other information incorporated by
reference in this prospectus supplement and the accompanying
prospectus, when making an investment decision.
Inhibitex is a biopharmaceutical company focused on the
development of differentiated anti-infective products to prevent
or treat serious infections. Our research and development
efforts are currently focused on oral, small molecule compounds
to treat viral infections, and in particular, chronic infections
caused by HCV and herpes zoster, also referred to as shingles,
which is caused by the varicella zoster virus (VZV).
Currently available antiviral therapies that are used to treat
these and other infections have a number of therapeutic
limitations, including inadequate potency, significant adverse
side effects, complex and inconvenient dosing schedules and
diminishing efficacy due to the emergence of drug-resistant
viruses. We believe that our antiviral drug candidates have the
potential to address a number of these limitations, as well as
unmet medical needs in their respective intended indications. In
addition to our antiviral programs, we have also licensed the
rights to certain intellectual property from our MSCRAMM protein
platform to Pfizer, Inc. (Pfizer) for the
development of active vaccines to prevent staphylococcal
infections.
Our lead product candidates are INX-189, a nucleotide polymerase
inhibitor we are developing to treat infections caused by HCV,
and FV-100, an orally available nucleoside analogue prodrug
which we are developing to treat shingles (herpes
zoster). We recently announced top-line safety and
antiviral data from our Phase 1b multiple ascending dose trial
in HCV genotype 1 treatment-naïve patients and top-line
data from a Phase II clinical trial of FV-100 in shingles
patients. Our preclinical pipeline includes other nucleotide
polymerase inhibitors, or protides, which we are developing to
treat infections caused by HCV. We are currently developing
plans to further evaluate the safety and antiviral activity of
INX-189 in a Phase 2 program that we anticipate could begin in
the third quarter of 2011. We have also licensed to Pfizer the
rights to use certain intellectual property for its use in the
development of staphylococcal vaccines.
We have retained all worldwide rights to both INX-189 and FV-100
and intend to explore establishing strategic collaborations,
partnerships and alliances that we believe can accelerate the
development and commercialization of our antiviral product
candidates through clinical development, manufacturing and
commercialization.
Recent
Developments
INX-189
:
In March 2011, we announced top-line
safety and antiviral data from its multiple ascending dose Phase
1b clinical trial of INX-189. 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
log
10
IU/mL,
respectively. INX-189, dosed once-daily at 50 mg for one
day, followed by 9 mg for six days, achieved a median HCV
RNA reduction from baseline of -0.50
log
10
IU/mL.
The median HCV RNA decline from baseline observed in patients
that received placebo was -0.20
log
10
IU/mL.
INX-189, dosed once-daily in combination with RBV for seven days
at 9 mg and 25 mg, resulted in median HCV RNA
reductions from baseline of -0.75 and -1.56
log
10
IU/mL, respectively. The median HCV RNA decline from baseline
observed in patients that received placebo and RBV was 0.04
log
10
IU/mL.
In addition to these median reductions in viral load, clinically
meaningful decreases in alanine transaminase (ALT) levels were
observed for patients receiving INX-189 at all dose levels, and
no patients experienced viral breakthrough. Additional data
available from the Phase 1b study indicate that INX-189 was
generally well tolerated. There was one serious adverse event
(atrial fibrillation) reported in a subject treated with RBV and
placebo. All other reported adverse events were mild or
moderate, with the most common adverse event in
S-3
INX-189 treated subjects being headache. There were no
discontinuations of treatment due to adverse events and there
were no adverse events related to changes in clinical laboratory
evaluations or ECGs.
Our
Product Candidates
The following table summarizes key information regarding our
anti-infective product candidates:
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Stage of
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Marketing
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Drug Candidate
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Indication
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Development
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Rights
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Antivirals
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INX-189
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Treatment of Chronic
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Clinical
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Inhibitex
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Hepatitis C Infection
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(Phase 1b
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HCV Nucleotide Polymerase Inhibitors
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Treatment of Chronic
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Preclinical
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Inhibitex
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Hepatitis C Infection
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FV-100
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Treatment of Herpes
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Clinical
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Zoster
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(Phase 2
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(shingles)
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Antibacterials
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Staphylococcal Vaccines
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Active Vaccine to Prevent
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Clinical
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Pfizer
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S. aureus infections
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(Phase 1
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Aurexis
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Treatment of S. aureus
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Clinical
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Bloodstream Infections
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(Phase 2
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Our
Strategy
Our goal is to become a leading biopharmaceutical company that
develops differentiated products that can prevent and treat
serious infections. In order to achieve this strategic goal, we
intend to employ the following strategies:
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Focus Our Resources on the Development of Our Antiviral
Product Candidates
. In the near-tern, we plan to focus our
resources primarily on further developing INX-189, and other HCV
nucleoside polymerase inhibitors, for the treatment of chronic
hepatitis C, and FV-100 for the reduction of
shingles-associated pain and the prevention of PHN. More
specifically, we intend to:
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Further evaluate the safety and antiviral activity of INX-189 in
a Phase 2 program that we anticipate could begin in the third
quarter of 2011;
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Nominate another HCV nucleotide polymerase inhibitor for
advancement into IND-enabling good laboratory practices
(GLP) preclinical studies in 2011; and
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S-4
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Complete a full evaluation of the Phase 2 FV-100 data and
post hoc analyses, conduct additional market research, including
reimbursement, pricing, and competitive analyses, etc. and
finalize our potential future developmental plans for FV-100.
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Seek Strategic Collaborations to Accelerate the Development
of Our Product Candidates to Optimize Economic Returns while
Managing Risk
. We intend to explore establishing strategic
licenses and collaborations, partnerships, alliances or enter
into other transactions in the future with pharmaceutical or
biopharmaceutical companies with greater clinical development,
manufacturing and commercialization capabilities that we believe
can accelerate the development
and/or
commercialization of INX-189 and FV-100.
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Continue to support our existing license and collaboration
agreement with Pfizer for the development of staphylococcal
vaccines as needed
. In 2010, Pfizer initiated a Phase I
trial of the SA3Ag vaccine, which includes intellectual property
covered under our license agreement with them. Pfizer is
responsible for all preclinical, clinical and commercial
activities relating to the program, while we maintain
intellectual property covered under the license and provide
additional research support as needed.
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We have not received regulatory approval to sell or market any
of our current or past product candidates, nor do we currently
have any commercialization capabilities. Therefore, it is
possible that we may never successfully derive any commercial
revenues from any of our existing or future product candidates.
Corporate
Information
We were incorporated in Delaware in May 1994. Our principal
executive offices are located at 9005 Westside Parkway,
Alpharetta, Georgia 30009. Our telephone number is
(678) 746-1100.
Our website is
www.inhibitex.com
. Information contained
on our website is not incorporated by reference into and does
not constitute part of this prospectus.
S-5
The
Offering
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Common stock offered by us in this offering
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shares.
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Common stock to be outstanding immediately after this offering
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shares.
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Use of proceeds
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We intend to use the net proceeds from this offering for working
capital and general corporate purposes, including a Phase 2
clinical trial for INX-189, and research and development
expenses related to our other development programs. See
Use of Proceeds on
page S-27
of this prospectus supplement.
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NASDAQ Capital Market Symbol
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INHX.
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Risk factors
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This investment involves a high degree of risk. See Risk
Factors beginning on
page S-7
of this prospectus supplement.
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The number of shares of our common stock that will be
outstanding immediately after this offering as shown above is
based on 62,439,215 shares outstanding as of March 31,
2011. The number of shares outstanding as of March 31,
2011, as used throughout this prospectus supplement, unless
otherwise indicated, excludes:
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6,860,800 shares of common stock issuable upon the exercise
of stock options outstanding as of March 31, 2011 at a
weighted average exercise price of $1.60 per share;
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2,020,328 shares of common stock reserved for future
issuance under our equity incentive plans as of March 31,
2011; and
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12,868,100 shares of common stock issuable upon exercise of
warrants outstanding as of March 31, 2011 at a weighted
average exercise price of $1.14 per share with expiration dates
ranging from May 12, 2011 to September 26, 2018.
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Except as otherwise indicated, all information in this
prospectus supplement assumes no exercise by the underwriters of
their over-allotment option.
S-6
RISK
FACTORS
An investment in our securities involves a substantial risk
of loss. You should carefully consider these risk factors,
together with all of the other information included or
incorporated by reference in this prospectus supplement and the
accompanying prospectus, as modified and superseded pursuant to
Rule 412 under the Securities Act, before you decide to
invest in our securities. The occurrence of any of the following
risks could harm our business. In that case, the trading price
of our common stock could decline, and you may lose all or part
of your investment. Additional risks and uncertainties not
presently known to us or that we currently deem immaterial may
also impair our operations. You should also refer to the other
information contained in this prospectus supplement and the
accompanying prospectus or incorporated by reference herein and
therein, including our financial statements and the notes to
those statements and the information set forth under the heading
Special Note Regarding Forward-Looking
Statements.
Risks
Related to this Offering
We
will have broad discretion in how we use the proceeds, and we
may use the proceeds in ways in which you and other shareholders
may not agree with.
We intend to use the net proceeds from this offering for working
capital and general corporate purposes, including further
development of our product candidates. Our management will have
broad discretion in the application of the proceeds from this
offering and could spend the proceeds in ways that do not
necessarily improve our operating results or enhance the value
of our common stock.
Investors
in this offering will suffer immediate and substantial dilution
in the net tangible book value per share of our common
stock.
Because the price per share in this offering is substantially
higher than the net tangible book value per share of common
stock, investors in this offering will suffer immediate and
substantial dilution in the net tangible book value per share of
our common stock. Based on an offering price of
$ per share, if you purchase
securities in this offering, you will suffer immediate and
substantial dilution of approximately
$ per share in the net tangible
book value of our common stock. See Dilution on
page S-28
for a more detailed discussion of the dilution you will incur in
connection with this offering.
Risks
Relating to our Development of our Product Candidates
All of
our product candidates are in the early stages of development
and their commercial viability remains subject to the successful
outcome of current and future preclinical studies, clinical
trials, regulatory approvals and the risks generally inherent in
the development of pharmaceutical product candidates. If we are
unable to successfully advance or develop our product
candidates, our business will be materially
harmed.
In the near-term, failure to successfully advance the
development of one or more of our product candidates may have a
material adverse effect on us. To date, we have not successfully
developed or commercially marketed, distributed or sold any
product candidates. The success of our business depends
primarily upon our ability to successfully advance the
development of our product candidates through preclinical
studies and clinical trials, have these product candidates
approved for sale by the United States Food and Drug
Administration (FDA) or regulatory authorities in
other countries, and ultimately have our product candidates
successfully commercialized by us or a strategic collaborator.
We cannot assure you that the results of our ongoing preclinical
studies or clinical trials will support or justify the continued
development of our product candidates, or that we will receive
approval from the FDA, or similar regulatory authorities in
other countries, to advance the development of our product
candidates.
Our product candidates must satisfy rigorous regulatory
standards of safety and efficacy before we can advance or
complete their clinical development or they can be approved for
sale. To satisfy these standards, we must engage in expensive
and lengthy preclinical studies and clinical trials, develop
acceptable
S-7
manufacturing processes, and obtain regulatory approval of our
product candidates. Despite these efforts, our product
candidates may not:
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offer therapeutic or other medical benefits over existing drugs
or other product candidates in development to treat the same
patient population;
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be proven to be safe and effective in current and future
preclinical studies or clinical trials;
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have the desired effects;
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be free from undesirable or unexpected effects;
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meet applicable regulatory standards;
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be capable of being formulated and manufactured in commercially
suitable quantities and at an acceptable cost; or
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be successfully commercialized by us or by collaborators.
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Even if we demonstrate favorable results in preclinical studies
and early-stage clinical trials, we cannot assure you that the
results of late-stage clinical trials will be favorable enough
to support the continued development of our product candidates.
A number of companies in the pharmaceutical and
biopharmaceutical industries have experienced significant
delays, setbacks and failures in all stages of development,
including late-stage clinical trials, even after achieving
promising results in preclinical testing or early-stage clinical
trials. Accordingly, results from completed preclinical studies
and early-stage clinical trials of our product candidates may
not be predictive of the results we may obtain in later-stage
trials. Furthermore, even if the data collected from preclinical
studies and clinical trials involving any of our product
candidates demonstrate a satisfactory safety and efficacy
profile, such results may not be sufficient to support the
submission of a NDA or a Biologic License Application
(BLA) to obtain regulatory approval from the FDA in
the United States (U.S.) or other similar regulatory
agencies in other jurisdictions, which is required to market and
sell the product.
Our product candidates will require significant additional
research and development efforts, the commitment of substantial
financial resources, and regulatory approvals prior to advancing
into further clinical development or being commercialized by us
or collaborators. We cannot assure you that any of our product
candidates will successfully progress through the drug
development process or will result in a commercially viable
product. We do not expect any of our product candidates to be
commercialized by us or collaborators for at least several years.
If the
actual or perceived therapeutic benefits or the safety profile
of INX-189 are not equal to or better than other competing
anti-viral treatments approved for sale or in clinical
development, or if the dosing of INX-189 is not amenable to
combination with other existing or future anti-viral therapies
for the treatment of chronic hepatitis C, we may terminate the
development of INX-189 at any time, or our ability to generate
significant revenue from the sale of INX-189, if approved, may
be limited and our potential profitability could be
harmed.
We are aware of a number of companies developing various classes
of direct acting antiviral product candidates for the treatment
of chronic hepatitis C, some of which are of a similar
class to INX-189. Many of these product candidates are further
advanced in clinical development than INX-189, therefore their
time to approval and commercialization may be sooner than that
for INX-189. Accordingly, if at any time we believe that INX-189
may not provide meaningful therapeutic benefits, perceived or
real, equal to or better than our competitors compounds,
or we believe that INX-189 may not have as favorable a safety
profile as potentially competitive compounds, or we believe
INX-189 may not be amendable for use in a combination therapy
with existing or future treatments for chronic hepatitis C,
we may delay or terminate the future development of INX-189 at
any time. We cannot provide any assurance that future
preclinical studies or clinical trials of INX-189 will
demonstrate any meaningful therapeutic benefits over potentially
competitive compounds in development or an acceptable safety
profile sufficient to justify its continued development, or
whether INX-189 is amenable to combination therapy with the
current standard of care or future approved antivirals for the
treatment of hepatitis C.
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Our
product candidates may exhibit undesirable side effects when
used alone or in combination with other approved pharmaceutical
products or investigational new drugs, which may delay or
preclude their further development or regulatory approval, or
limit their use if approved.
Throughout the drug development process, we must continually
demonstrate the safety and tolerability of our product
candidates to obtain regulatory approval to further advance
their clinical development or to market them. Even if our
product candidates demonstrate biologic activity and clinical
efficacy, any unacceptable adverse side effects or toxicities,
when administered alone or in the presence of other
pharmaceutical products, which can arise at any stage of
development, may outweigh their potential benefit. In
preclinical studies and clinical trials we have conducted to
date, our product candidates have demonstrated an acceptable
safety profile, although these studies and trials have involved
a small number of subjects or patients over a limited period of
time. We may observe adverse or significant adverse events or
drug-drug interactions in future preclinical studies or clinical
trials of these product candidates, which could result in the
delay or termination of their development, prevent regulatory
approval, or limit their market acceptance if they are
ultimately approved.
The
safety or antiviral profile of INX-189 may differ in combination
therapy with other existing or future drugs used to treat
chronic hepatitis C, and therefore may preclude its further
development or approval, which could materially harm our
business.
It is anticipated that in the future, the optimized treatment of
chronic hepatitis C will involve the combination of at
least two or more antiviral compounds. Accordingly, Phase 2 and
Phase 3 clinical trials of other investigational direct acting
antiviral agents, some similar to INX-189, are now being
conducted in combination with the current standard of care.
Therefore, the clinical development and commercialization
pathway for INX-189, or any other product candidate we may
develop in the future for the treatment of chronic
hepatitis C, will likely require that it be evaluated in
clinical trials in combination with other currently-approved
antivirals or those still in development. Even if INX-189
demonstrates meaningful therapeutic benefits equal to or better
than other similar compounds in development, an acceptable
safety profile, and a dose amenable to combination therapy in
Phase 2 and other future-stage clinical trials, when combined
with other existing or HCV therapies, it may demonstrate
unexpected side effects. We cannot assure you that INX-189 will
be amenable for use in combination with existing or future
antiviral HCV therapies in clinical development. Further, to
evaluate INX-189 in combination therapy with other antivirals in
clinical development may require us to establish collaborations,
licensing arrangements or alliances with third parties. There is
no assurance we will be able to enter into such arrangements on
favorable terms, or at all.
The
development of INX-189 in combination with other drugs may
present additional risks beyond those inherent in the drug
development of INX-189 administered alone.
We are developing INX-189 to treat chronic infections caused by
HCV. Potential therapeutic regimens currently being tested, or
anticipated to be tested in the future, include INX-189 in
combination with:
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pegylated interferon and ribavirin, which in combination are
considered to be the current standard of care;
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pegylated interferon alone;
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ribavirin alone;
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other yet-to-be-approved direct acting antiviral agents
currently in clinical development; and
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pegylated interferon and/or ribavirin plus one or more direct
acting antiviral agents in clinical development or approved for
sale in the future.
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These potential therapeutic regimens and planned clinic studies
of INX-189 in combination with other approved and unapproved
agents are subject to regulatory, commercial, manufacturing, and
other risks that may be additional to the risks of developing a
product candidate that is not used in combination. Regulatory
guidelines for the use of direct acting antiviral drugs are
evolving in the United States, Europe, and other countries. We
anticipate that regulatory guidelines and regulatory agency
responses to our and our competitors development programs
will continue to change, resulting in the risk that our
activities may not
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meet unanticipated new standards or requirements, which could
lead to delay, additional expense, or potential failure of our
development activities. Our development program for INX-189 may
involve the testing of it in combination with unapproved product
candidates, which may increase the risk of significant adverse
effects or clinical failure.
In order for us to pursue this combination strategy, we may need
to engage the interest of other bio-pharmaceutical or
pharmaceutical companies to do so, as we do not have another
direct antiviral to combine with INX-189. Our ability to engage
this interest will be impacted by other companies
perceived need to combine with an agent such as INX-189, as well
as the risk involved in combining their agent with an unapproved
product candidate such as INX-189. If they establish criteria
for combination that we have not yet satisfied with INX-189, we
could experience difficulties or delays in pursuing such
combination trials. If we are unable to combine INX-189 with
other unapproved direct acting antiviral agents, our business
prospects could be harmed.
There
is no assurance that in future clinical studies of INX-189,
where it may be dosed for longer duration or in combination with
other agents, that we will be able to identify safe and
tolerable doses that result in clinical benefit, as measured by
the clearance of the virus and sustainability of such
clearance.
Future clinical development of INX-189 is anticipated to include
trials where INX-189 will be dosed for up to 12 weeks, and
potentially longer, with current standard of care and/ or other
approved or unapproved direct acting antivirals. The
recently-completed Phase 1b study evaluated the safety,
tolerability and antiviral activity of several doses of INX-189
for seven days. It is possible that the safety and tolerability
of INX-189 over longer durations of treatment may be inferior to
that observed at the same dose levels at a shorter duration of
treatment. If the tolerability of doses of INX-189 required for
long-term treatment of HCV patients is unacceptable or
unfavorable relative to competitive product candidates, then the
prospects for developing
INX-189
as a
treatment for chronic hepatitis C may be diminished,
causing our business to be harmed.
If the
actual or perceived therapeutic benefits of FV-100 are not
sufficiently different from existing generic drugs currently
used to treat shingles or reduce or prevent shingles-associated
pain and PHN, we may terminate the development of FV-100 at any
time, or our ability to generate significant revenue from the
sale of FV-100, if approved, may be limited and our potential
profitability could be harmed.
Valacyclovir, famciclovir and acyclovir are existing generic
drugs currently used to treat shingles patients. Generic drugs
are compounds that have no remaining patent protection, and
generally have an average selling price substantially lower than
drugs that are protected by patents and intellectual property
rights. Unless a patented drug can differentiate itself from
generic drugs treating the same condition or disease in a
clinically meaningful manner, the existence of generic
competition in any indication may impose significant pricing
pressure on patented drugs. Accordingly, if at any time we
believe that FV-100 may not provide meaningful therapeutic
benefits, perceived or real, over these existing generic drugs,
we may delay or terminate its future development. We cannot
provide any assurance that later-stage clinical trials of FV-100
will demonstrate any meaningful therapeutic benefits over
existing generic drugs sufficient to justify its continued
development. Further, if we successfully develop FV-100 and it
is approved for sale, we cannot assure you that any real or
perceived therapeutic benefits of FV-100 over generic drugs will
result in it being prescribed by physicians or commanding a
price higher than the existing generic drugs.
If the
results of preclinical studies or clinical trials for our
product candidates, including those that are subject to existing
or future license or collaboration agreements, are unfavorable
or delayed, we could be delayed or precluded from the further
development or commercialization of our product candidates,
which could materially harm our business.
In order to further advance the development of, and ultimately
receive regulatory approval to sell, our product candidates, we
must conduct extensive preclinical studies and clinical trials
to demonstrate their safety and efficacy to the satisfaction of
the FDA or similar regulatory authorities in other countries, as
the case may be. Preclinical studies and clinical trials are
expensive, complex, can take many years to complete, and have
highly uncertain outcomes. Delays, setbacks, or failures can
occur at any time, or in any phase of preclinical or clinical
testing, and can result from concerns about safety or toxicity,
a lack of demonstrated efficacy or
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superior efficacy over other similar products that have been
approved for sale or are in more advanced stages of development,
poor study or trial design, and issues related to the
formulation or manufacturing process of the materials used to
conduct the trials. The results of prior preclinical studies or
clinical trials are not necessarily predictive of the results we
may observe in later stage clinical trials. In many cases,
product candidates in clinical development may fail to show
desired safety and efficacy characteristics despite having
favorably demonstrated such characteristics in preclinical
studies or earlier stage clinical trials.
In addition, we may experience numerous unforeseen events
during, or as a result of, preclinical studies and the clinical
trial process, which could delay or impede our ability to
advance the development of, receive regulatory approval for, or
commercialize our product candidates, including, but not limited
to:
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communications with the FDA, or similar regulatory authorities
in different countries, regarding the scope or design of a trial
or trials;
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regulatory authorities or institutional review boards
(IRBs) not authorizing us to commence or conduct a
clinical trial at a prospective trial site;
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enrollment in our clinical trials being delayed, or proceeding
at a slower pace than we expected, because we have difficulty
recruiting patients or because participants drop out of our
clinical trials at a higher rate than we anticipated;
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our third party contractors, upon whom we rely for conducting
preclinical studies, clinical trials and manufacturing of our
trial materials, may fail to comply with regulatory requirements
or meet their contractual obligations to us in a timely manner;
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having to suspend or ultimately terminate our clinical trials if
participants are being exposed to unacceptable health or safety
risks;
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regulatory authorities or IRBs requiring that we hold, suspend
or terminate our preclinical studies and clinical trials for
various reasons, including non-compliance with regulatory
requirements; and
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the supply or quality of drug material necessary to conduct our
preclinical studies or clinical trials being insufficient,
inadequate or unavailable.
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Even if the data collected from preclinical studies or clinical
trials involving our product candidates demonstrate a
satisfactory safety and efficacy profile, such results may not
be sufficient to support the submission of a NDA or BLA to
obtain regulatory approval from the FDA in the U.S., or other
similar foreign regulatory authorities in foreign jurisdictions,
which is required for us to market and sell the product.
If
third party vendors upon whom we rely to conduct our preclinical
studies or clinical trials do not perform or fail to comply with
strict regulations, these studies or trials of our product
candidates may be delayed, terminated, or fail, or we could
incur significant additional expenses, which could materially
harm our business.
We have limited resources dedicated to designing, conducting and
managing preclinical studies and clinical trials. We have
historically relied, and intend to continue to rely, on third
parties, including clinical research organizations, consultants
and principal investigators, to assist us in designing,
managing, monitoring and conducting our preclinical studies and
clinical trials. We rely on these vendors and individuals to
perform many facets of the drug development process, including
certain preclinical studies, the recruitment of sites and
patients for participation in our clinical trials, maintenance
of good relations with the clinical sites, and ensuring that
these sites are conducting our trials in compliance with the
trial protocol and applicable regulations. If these third
parties fail to perform satisfactorily, or do not adequately
fulfill their obligations under the terms of our agreements with
them, we may not be able to enter into alternative arrangements
without undue delay or additional expenditures, and therefore
the preclinical studies and clinical trials of our product
candidates may be delayed or prove unsuccessful. Further, the
FDA may inspect some of the clinical sites participating in our
clinical trials in the U.S., or our third-party vendors
sites, to determine if our clinical trials are being conducted
according to Good Clinical Practice (GCP)
regulations. If we or the FDA determine that our third-party
vendors are not in compliance with, or have not conducted our
clinical trials according to, applicable regulations we may be
forced to delay, repeat or terminate such clinical trials.
S-11
We
have limited capacity for recruiting and managing clinical
trials, which could impair our timing to initiate or complete
clinical trials of our product candidates and materially harm
our business.
We have limited capacity to recruit and manage the clinical
trials necessary to obtain FDA approval or approval by other
regulatory authorities. By contrast, larger pharmaceutical and
bio-pharmaceutical companies often have substantial staffs with
extensive experience in conducting clinical trials with multiple
product candidates across multiple indications. In addition,
they may have greater financial resources to compete for the
same clinical investigators and patients that we are attempting
to recruit for our clinical trials. As a result, we may be at a
competitive disadvantage that could delay the initiation,
recruitment, timing and completion of our clinical trials and
obtaining regulatory approvals, if at all, for our product
candidates.
We and
our collaborators must comply with extensive government
regulations in order to advance our product candidates through
the development process and ultimately obtain and maintain
marketing approval for our products in the U.S. and
abroad.
Product candidates that we or our collaborators are developing
require regulatory approval to advance through clinical
development and to ultimately be marketed and sold, and are
subject to extensive and rigorous domestic and foreign
government regulation. In the U.S., the FDA regulates, among
other things, the development, testing, manufacture, safety,
efficacy, record-keeping, labeling, storage, approval,
advertising, promotion, sale and distribution of pharmaceutical
and biopharmaceutical products. Our product candidates are also
subject to similar regulation by foreign governments to the
extent we seek to develop or market them in those countries. We,
or our collaborators, must provide the FDA and foreign
regulatory authorities, if applicable, with preclinical and
clinical data, as well as data supporting an acceptable
manufacturing process, that appropriately demonstrate our
product candidates safety and efficacy before they can be
approved for the targeted indications. None of our product
candidates has been approved for sale in the U.S. or any
foreign market, and we cannot predict whether we or our
collaborators will obtain regulatory approval for any product
candidate we are developing or plan to develop. The regulatory
review and approval process can take many years, is dependent
upon the type, complexity, novelty of, and medical need for the
product candidate, requires the expenditure of substantial
resources, and involves post-marketing surveillance and
vigilance and ongoing requirements for post-marketing studies or
Phase 4 clinical trials. In addition, we or our collaborators
may encounter delays in, or fail to gain, regulatory approval
for our product candidates based upon additional governmental
regulation resulting from future legislative, administrative
action or changes in FDA policy or interpretation during the
period of product development. Delays or failures in obtaining
regulatory approval to advance our product candidates through
clinical development, and ultimately commercialize them, may:
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adversely impact our ability to raise sufficient capital to fund
the development of the program candidates;
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adversely affect our ability to further develop or commercialize
any of our product candidates;
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diminish any competitive advantages that we or our collaborators
may have or attain; and
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adversely affect the receipt of potential milestone payments and
royalties from the sale of our products or product revenues.
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Furthermore, any regulatory approvals, if granted, may later be
withdrawn. If we or our collaborators fail to comply with
applicable regulatory requirements at any time, or if
post-approval safety concerns arise, we or our collaborators may
be subject to restrictions or a number of actions, including:
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delays, suspension or termination of clinical trials related to
our products;
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refusal by regulatory authorities to review pending applications
or supplements to approved applications;
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product recalls or seizures;
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suspension of manufacturing;
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withdrawals of previously approved marketing
applications; and
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fines, civil penalties and criminal prosecutions.
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Additionally, at any time we or our collaborators may
voluntarily suspend or terminate the preclinical or clinical
development of a product candidate, or withdraw any approved
product from the market, if we believe
S-12
that it may pose an unacceptable safety risk to patients, or if
the product candidate or approved product no longer meets our
business objectives. The ability to develop or market a
pharmaceutical product outside of the U.S. is contingent
upon receiving appropriate authorization from the respective
foreign regulatory authorities. Foreign regulatory approval
processes typically include many, if not all, of the risks and
requirements associated with the FDA regulatory process for drug
development and may include additional risks.
We
have limited experience in the development of small molecule
antiviral product candidates and therefore may encounter
difficulties developing our product candidates or managing our
operations in the future.
Our two lead antiviral product candidates, INX-189 and FV-100,
are chemical compounds, also referred to as small molecules. We
have limited experience in the discovery, development and
manufacturing of these small molecule antiviral compounds. In
order to successfully develop these product candidates, we must
continuously supplement our research, clinical development,
regulatory, medicinal chemistry, virology and manufacturing
capabilities through the addition of key employees, consultants
or third-party contractors to provide certain capabilities and
skill sets that we do not possess. We cannot assure you that we
will be able to attract or retain such qualified employees,
consultants or third-party contractors with appropriate small
molecule antiviral drug development experience. In the event we
cannot attract such capabilities or successfully develop or
manage our antiviral pipeline, our business could be materially
harmed.
If we
are unable to retain or attract key employees, advisors or
consultants, we may be unable to successfully develop our
product candidates in a timely manner, if at all, or otherwise
manage our business effectively.
We have adopted an operating model that largely relies on the
outsourcing of a number of responsibilities and key activities
to third-party consultants and contract research and
manufacturing organizations in order to advance the development
of our product candidates. Therefore, our success depends in
part on our ability to retain highly qualified key management,
personnel and directors to develop, implement and execute our
business strategy, operate the company and oversee the
activities of our consultants and contractors, as well as
academic and corporate advisors or consultants to assist us in
this regard. We are currently highly dependent upon the efforts
of our management team. In order to develop our product
candidates, we need to retain or attract certain personnel,
consultants or advisors with experience in a number of
disciplines, including research and development, clinical
trials, medical matters, government regulation of
pharmaceuticals, manufacturing, formulation and chemistry,
business development, accounting, finance, human resources and
information systems. Although we have not experienced material
difficulties in retaining key personnel in the past, we may not
be able to continue to do so in the future on acceptable terms,
if at all. If we lose any key managers or employees, or are
unable to attract and retain qualified key personnel, directors,
advisors or consultants, the development of our product
candidates could be delayed or terminated and our business may
be harmed.
If
third-party contract manufacturers upon whom we rely to
formulate and manufacture our product candidates do not perform,
fail to manufacture according to our specifications or fail to
comply with strict regulations, our preclinical studies or
clinical trials could be adversely affected and the development
of our product candidates could be delayed or terminated or we
could incur significant additional expenses.
We do not own or operate any manufacturing facilities. We have
historically contracted with third-party contract manufacturers
and organizations to formulate and manufacture the preclinical
and clinical materials we use to test our product candidates in
development. We intend to continue to rely on third-party
contractors, at least for the foreseeable future, to formulate
and manufacture these preclinical and clinical materials. Our
reliance on third-party contract manufacturers exposes us to a
number of risks, any of which could delay or prevent the
completion of our preclinical studies or clinical trials, or the
regulatory approval or commercialization of our product
candidates, result in higher costs, or deprive us of potential
product revenues. Some of these risks include:
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our third-party contractors failing to develop an acceptable
formulation to support later-stage clinical trials for, or the
commercialization of, our product candidates;
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our contract manufacturers failing to manufacture our product
candidates according to their own standards, our specifications,
current good manufacturing practices (cGMPs) or
otherwise manufacturing material that we or the FDA may deem to
be unsuitable in our clinical trials;
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our contract manufacturers being unable to increase the scale
of, increase the capacity for, or reformulate the form of our
product candidates. We may experience a shortage in supply, or
the cost to manufacture our products may increase to the point
where it adversely affects the cost of our product candidates.
We cannot assure you that our contract manufacturers will be
able to manufacture our products at a suitable scale, or we will
be able to find alternative manufacturers acceptable to us that
can do so;
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our contract manufacturers placing a priority on the manufacture
of their own products, or other customers products;
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our contract manufacturers failing to perform as agreed or not
remain in the contract manufacturing business; and
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our contract manufacturers plants being closed as a result
of regulatory sanctions or a natural disaster.
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Manufacturers of pharmaceutical products are subject to ongoing
periodic inspections by the FDA, the U.S. Drug Enforcement
Administration (DEA) and corresponding state and
foreign agencies to ensure strict compliance with FDA-mandated
cGMPs, other government regulations and corresponding foreign
standards. While we are obligated to audit their performance, we
do not have control over our third-party contract
manufacturers compliance with these regulations and
standards. Failure by our third-party manufacturers, or us, to
comply with applicable regulations could result in sanctions
being imposed on us or the drug manufacturer from the production
of other third-party products. These sanctions may include
fines, injunctions, civil penalties, failure of the government
to grant pre-market approval of drugs, delays, suspension or
withdrawal of approvals, seizures or recalls of product,
operating restrictions and criminal prosecutions, any of which
could significantly and adversely affect our business.
In the
event that we need to change our third-party contract
manufacturers, our preclinical studies, clinical trials or the
commercialization of our product candidates could be delayed,
adversely affected or terminated, or such a change may result in
significantly higher costs.
Due to regulatory restrictions inherent in an IND, NDA or BLA,
various steps in the manufacture of our product candidates may
need to be sole-sourced. In accordance with cGMPs, changing
manufacturers may require the re-validation of manufacturing
processes and procedures, and may require further preclinical
studies or clinical trials to show comparability between the
materials produced by different manufacturers. Changing our
current or future contract manufacturers may be difficult for us
and could be costly, which could result in our inability to
manufacture our product candidates for an extended period of
time and therefore a delay in the development of our product
candidates. Further, in order to maintain our development time
lines in the event of a change in our third-party contract
manufacturer, we may incur significantly higher costs to
manufacture our product candidates.
Our
industry is highly competitive and subject to rapid
technological changes. As a result, we may be unable to compete
successfully or develop innovative products, which could harm
our business.
Our industry is highly competitive and characterized by rapid
technological change. Key competitive factors in our industry
include, among others, the ability to successfully advance the
development of a product candidate through preclinical and
clinical trials; the efficacy, toxicological, safety, resistance
or cross-resistance, and dosing profile of a product or product
candidate; the timing and scope of regulatory approvals, if ever
achieved; reimbursement rates for and the average selling price
of competing products and pharmaceutical products in general;
the availability of raw materials and qualified contract
manufacturing and manufacturing capacity; manufacturing costs;
establishing and maintaining intellectual property and patent
rights and their protection; and sales and marketing
capabilities. If ultimately approved, INX-189 or FV-100, or any
other product candidate we may develop, would compete against
existing therapies or other product candidates in various stages
of clinical development that we believe may potentially become
available in the future for the treatment of chronic
hepatitis C, shingles-associated pain and the prevention of
staphylococcal infections.
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Some of the large pharmaceutical companies that currently market
products that would compete with our product candidates, if
approved, include, but are not limited to: Merck and Roche in
the hepatitis C market and GlaxoSmithKline and Merck in the
shingles market.
In addition to existing therapies, there are many other
pharmaceutical and biopharmaceutical companies developing
numerous direct acting antiviral product candidates across
various classes for the treatment for chronic hepatitis C,
including, but not limited to, Abbott, Achillion, Anadys,
Bristol Myers Squibb, Gilead, Idenix, Pfizer,
Johnson & Johnson, Pharmasset and Vertex, which may
compete with INX-189 or any other HCV nucleotide polymerase
inhibitor we may develop in the future. Most of the product
candidates being developed by these companies, and in particular
those that belong to the class of compounds referred to as
protease inhibitors, are further advanced in their clinical
development than INX-189. Further, Pharmasset and Idenix are
developing nucleotide analogues, which are similar to the
approach we are using for INX-189. Moreover, their lead
nucleotide analogues have advanced further in clinical
development and are currently in Phase 2 clinical trials.
While there are many direct acting antivirals in various stages
of clinical development, none has yet to be approved for sale by
the FDA or the European Medicines Agency (EMEA).
However, it is widely anticipated that one or two protease
inhibitors may be approved for sale by the FDA in 2011.
Accordingly, the competitive landscape for the treatment of
chronic hepatitis C is expected to be highly dynamic over
the next five to ten years. In order to compete effectively in
this market in the future, we believe a direct acting antiviral
will need to demonstrate a favorable toxicity profile,
sufficient potency across most or all HCV genotypes, high
resistance barriers, and be amenable to combination with other
direct acting antivirals in a low fixed oral dose.
Developing pharmaceutical product candidates is a highly
competitive, expensive and risky activity with a long business
cycle. Many organizations, including the large pharmaceutical
and biopharmaceutical companies that have existing products on
the market or in clinical development that could compete with
INX-189 or FV-100 have substantially more resources than we
have, and much greater capabilities and experience than we have
in research and discovery, designing and conducting preclinical
studies and clinical trials, operating in a highly regulated
environment, manufacturing drug substances and drug products,
and marketing and sales. Our competitors may be more successful
than we are in obtaining FDA or other regulatory approvals for
their product candidates and achieving broad market acceptance
once they are approved. Our competitors drugs or product
candidates may be more effective, have fewer negative side
effects, be more convenient to administer, have a more favorable
resistance profile, or be more effectively marketed and sold
than any drug we, or our potential collaborators, may develop or
commercialize. New drugs or classes of drugs from competitors
may render our product candidates obsolete or non-competitive
before we are able to successfully develop them or, if approved,
before we can recover the expenses of developing and
commercializing them. We anticipate that we or our collaborators
will face intense and increasing competition as new drugs and
drug classes enter the market and advanced technologies or new
drug targets become available. If our product candidates do not
demonstrate any competitive advantages over existing drugs, new
drugs or product candidates, we or our future collaborators may
terminate the development or commercialization of our product
candidates at any time.
We anticipate that our product candidates, and in particular
FV-100 if successfully developed and approved, will compete
directly or indirectly with existing generic drugs. Generic
drugs are drugs whose patent protection has expired, and
generally have an average selling price substantially lower than
drugs protected by intellectual property rights. Unless a
patented drug can differentiate itself from a generic drug in a
meaningful manner, the existence of generic competition in any
indication may impose significant pricing pressure on competing
patented drugs.
We also face, and will continue to face, intense competition
from other companies for collaborative arrangements with
pharmaceutical and biopharmaceutical companies, and for
attracting investigators and clinical sites capable of
conducting our preclinical studies and clinical trials. These
competitors, either alone or with their collaborators, may
succeed in developing technologies or products that are safer,
more effective, less expensive or easier to administer than
ours. Accordingly, our competitors may succeed in obtaining FDA
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or other regulatory approvals for their product candidates more
rapidly than we can. Companies that can complete clinical
trials, obtain required regulatory approvals and commercialize
their products before their competitors may achieve a
significant competitive advantage, including certain patent and
FDA marketing exclusivity rights that could delay the ability of
competitors to market certain products. We cannot assure you
that product candidates resulting from our research and
development efforts, or from joint efforts with our
collaborators, will be able to compete successfully with our
competitors existing products or products under
development.
Our
research and development efforts may not result in additional
HCV product candidates being discovered, which could limit our
ability to generate revenues in the future.
Our research and development efforts may not lead to the
discovery and development of any additional product candidates
that would be suitable for further preclinical or clinical
development to treat HCV. The development of additional HCV
product candidates requires significant research and preclinical
studies as well as a substantial commitment of resources. Many
lead compounds that appear promising in preclinical studies fail
to progress to become product candidates in clinical trials.
There is a great deal of uncertainty inherent in the research
and development process and, as a consequence, in our ability to
advance the development of other promising HCV product
candidates.
Our sponsored research with academic and commercial
institutions may be subject to restriction and change, which
could harm our ability to discover new HCV polymerase
inhibitors.
We expect to continue to collaborate with chemists and
biologists at academic and commercial institutions that assist
us in our research and preclinical development efforts of HCV
nucleotide polymerase inhibitors. Some of our product candidates
were discovered with the research assistance of these chemists
and biologists. Most of the scientists who have contributed to
the discovery of our product candidates are not our employees
and are employed by other institutions that may have other
commitments or may elect not to contract with us in the future,
which would limit their future availability to us.
We do
not have significant internal drug discovery capabilities, and
therefore we are primarily dependent on in-licensing or
acquiring development programs from third parties in order to
obtain additional product candidates.
We are currently focused on developing additional HCV nucleoside
polymerase inhibitor compounds. If in the future we decide to
further expand our pipeline, we will be largely dependent on
in-licensing or acquiring product candidates as we do not have
significant internal discovery capabilities at this time.
Accordingly, in order to generate and expand our development
pipeline, we have relied, and will continue to rely, on
obtaining discoveries, new technologies, intellectual property
and product candidates from third parties through sponsored
research, in-licensing arrangements or acquisitions. We may face
substantial competition from other biotechnology and
pharmaceutical companies, many of which may have greater
resources than we have, in obtaining these in-licensing,
sponsored research or acquisition opportunities. Additional
in-licensing or acquisition opportunities may not be available
to us on terms we find acceptable, if at all. In-licensed
compounds that appear promising in research or in preclinical
studies may fail to progress into further preclinical studies or
clinical trials. Our research and development efforts may not
lead to the nomination of any additional product candidates that
would be suitable for further preclinical or clinical
development. The discovery of additional product candidates
requires significant time, as well as a substantial commitment
of personnel and financial resources. There is a great deal of
uncertainty inherent in our research efforts and as a
consequence our ability to expand our development pipeline with
additional product candidates may not be successful.
If a
product liability claim is successfully brought against us for
uninsured liabilities, or such claim exceeds our insurance
coverage, we could be forced to pay substantial damage awards
that could materially harm our business.
The use of any of our existing or future product candidates in
clinical trials and the sale of any approved pharmaceutical
products may expose us to significant product liability claims.
We currently have product
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liability insurance coverage for our clinical trials in the
amount of $5.0 million. Such insurance coverage may not
protect us against any or all of the product liability claims
that may be brought against us in the future. We may not be able
to acquire or maintain adequate product liability insurance
coverage at a commercially reasonable cost or in sufficient
amounts or scope to protect us against potential losses. In the
event a product liability claim is brought against us, we may be
required to pay legal and other expenses to defend the claim, as
well as uncovered damage awards resulting from a claim brought
successfully against us. In the event any of our product
candidates are approved for sale by the FDA and commercialized,
we may need to substantially increase the amount of our product
liability coverage. Defending any product liability claim or
claims could require us to expend significant financial and
managerial resources, which could have an adverse effect on our
business.
If our
use of hazardous materials results in contamination or injury,
we could suffer significant financial loss.
Our research activities involve the controlled use of certain
hazardous materials and medical waste. Notwithstanding the
regulations controlling the use and disposal of these materials,
as well as the safety procedures we undertake, we cannot
eliminate the risk of accidental contamination or injury from
these materials. In the event of an accident or environmental
discharge or exposure, we may be held liable for any resulting
damages, which may exceed our financial resources and have an
adverse effect on our business.
Risks
Relating to the Commercialization of our Product
Candidates
We may
delay or terminate the development of a product candidate at any
time if we believe the perceived market or commercial
opportunity does not justify further investment, which could
materially harm our business.
Even if the results of preclinical studies and clinical trials
that we have conducted to-date or may conduct in the future
support further development of one or more of our product
candidates, we may delay, suspend or terminate the future
development of a product candidate at any time for strategic,
business, financial or other reasons, including the
determination or belief that the emerging profile of the product
candidate is such that it may not receive FDA approval, gain
meaningful market acceptance, generate a significant return to
shareholders, or otherwise provide any competitive advantages in
its intended indication or market.
If we
fail to enter into collaborations, license agreements or other
transactions with third parties to accelerate the development of
our product candidates, we will bear the risk of developmental
failure.
We plan to seek out-licensing opportunities as a way to
accelerate the development of any of our product candidates.
There is no guarantee that we will enter into a future
transaction on favorable terms, or at all, or that discussions
will initiate or progress on our desired timelines. Completing
transactions of this nature is difficult and time-consuming.
Potentially interested parties may decline to re-engage or may
terminate discussions based upon their assessment of our
competitive, financial, regulatory or intellectual property
position or for any other reason. Furthermore, we may choose to
defer consummating a transaction relating to any of our product
candidates until additional clinical data is obtained. If we
decide do not actively pursue a transaction until we have
additional clinical data, we and our stockholders will bear the
risk that our product candidate fails prior to any future
transaction.
If we
fail to enter into or maintain collaborations or other sales,
marketing and distribution arrangements with third parties to
commercialize our product candidates, or otherwise fail to
establish marketing and sales capabilities, we may not be able
to successfully commercialize our products.
We currently have no infrastructure to support the
commercialization of any of our product candidates, and have
little, if any, experience in the commercialization of
pharmaceutical products. Therefore, if our product candidates
are successfully developed and ultimately approved for sale, our
future profitability will depend largely on our ability to
access or develop suitable marketing and sales capabilities. We
anticipate that we will need to establish relationships with
other companies, through license and collaborations agreements,
to commercialize our product candidates in the U.S. and in
other countries around the world. To the extent that we enter
into these license and collaboration agreements, or marketing
and sales arrangements with other
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companies to sell, promote or market our products in the
U.S. or abroad, our product revenues, which may be in the
form of indirect revenue, a royalty, or a split of profits, will
depend largely on their efforts, which may not be successful. In
the event we develop a sales force and marketing capabilities,
this may result in us incurring significant costs before the
time that we may generate any significant product revenues. We
may not be able to attract and retain qualified third parties or
marketing or sales personnel, or be able to establish marketing
capabilities or an effective sales force.
If
government and third party payers fail to provide adequate
reimbursement or coverage for our products or those we develop
through collaborations, our revenues and potential for
profitability will be harmed.
In the U.S. and most foreign markets, our product revenues,
and therefore the inherent value of our product candidates, will
depend largely upon the reimbursement rates established by
third-party payers for such product candidates or products. Such
third-party payers include government health administration
authorities, managed-care organizations, private health insurers
and other similar organizations. These third-party payers are
increasingly challenging the price and examining the cost
effectiveness of medical products, services and pharmaceuticals.
In addition, significant uncertainty exists as to the
reimbursement status, if any, of newly approved drugs or
pharmaceutical products. Further, the comparative effectiveness
of new compounds over existing therapies and the assessment of
other non-clinical outcomes are increasingly being considered in
the decision by these payers to establish reimbursement rates.
We may also need to conduct post-marketing clinical trials in
order to demonstrate the cost-effectiveness of our products.
Such studies may require us to commit a significant amount of
management time and financial resources. We cannot assure you
that any products we successfully develop will be reimbursed in
part, or at all, by any third-party payers in any countries.
Domestic and foreign governments continue to propose legislation
designed to expand the coverage, yet reduce the cost, of
healthcare, including pharmaceutical drugs. In some foreign
markets, governmental agencies control prescription drugs
pricing and profitability. In the U.S., significant changes in
federal health care policy have been recently approved and will
mostly likely result in reduced reimbursement rates in the
future. We expect that there will continue to be federal and
state proposals to implement more governmental control over
reimbursement rates of pharmaceutical products. In addition, we
expect that increasing emphasis on managed care and government
intervention in the U.S. healthcare system will continue to
put downward pressure on the pricing of pharmaceutical products
domestically. Cost control initiatives could decrease the price
that we receive for any of our product candidates that may be
approved for sale in the future, which would limit our revenues
and profitability. Accordingly, legislation and regulations
affecting the pricing of pharmaceutical products may change
before our product candidates are approved for sale, which could
further limit or eliminate reimbursement rates for our product
candidates. Further, pressure from social activist groups, whose
goal it is to reduce the cost of drugs, particularly in less
developed nations, may also place downward pressure on the price
of drugs, which could result in downward pressure on the prices
of our products in the absence of generic competition.
If any
product candidates that we develop independently or through
collaborations are approved but do not gain meaningful
acceptance in their intended markets, we are not likely to
generate significant revenues or become
profitable.
Even if our product candidates are successfully developed and we
or a collaborator obtain the requisite regulatory approvals to
commercialize them in the future, they may not gain market
acceptance or utilization among physicians, patients or third
party payers. The degree of market acceptance that any of our
product candidates may achieve will depend on a number of
factors, including:
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the therapeutic efficacy or perceived benefit of the product
relative to existing therapies, if they exist;
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the timing of market approval and the existing market for
competitive drugs;
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the level of reimbursement provided by payers to cover the cost
of the product to patients;
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the net cost of the product to the user or payer;
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the convenience and ease of administration of our product;
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the products potential advantages over existing or
alternative therapies;
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the actual or perceived safety of similar classes of products;
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the actual or perceived existence, prevalence and severity of
negative side effects;
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the effectiveness of sales, marketing and distribution
capabilities; and
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the scope of the product label approved by the FDA.
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There can be no assurance that physicians will choose to
prescribe or administer our products, if approved, to the
intended patient population. If our products do not achieve
meaningful market acceptance, or if the market for our products
proves to be smaller than anticipated, we may not generate
significant revenues or ever become profitable.
Even
if we or a collaborator achieve market acceptance for our
products, we may experience downward pricing pressure on the
price of our products due to social or political pressure to
lower the cost of drugs, which would reduce our revenue and
future profitability.
Pressure from social activist groups and future government
regulations, whose goal it is to reduce the cost of drugs, also
may put downward pressure on the price of drugs, which could
result in downward pressure on the prices of our products in the
future.
We may
be unable to successfully develop a product candidate that is
the subject of collaboration if our collaborator does not
perform, terminates our agreement or delays the development of
our product candidate.
We expect to continue to enter into and rely on license and
collaboration agreements or other business arrangements with
third parties to further develop
and/or
commercialize our existing and future product candidates. Such
collaborators or partners may not perform as agreed upon or
anticipated, fail to comply with strict regulations, or elect to
delay or terminate their efforts in developing or
commercializing our product candidates even though we have met
our obligations under the arrangement. For example, if an
existing or future collaborator does not devote sufficient time
and resources to our collaboration arrangement, we may not
realize the full potential benefits of the arrangement, and our
results of operations may be adversely affected.
A majority of the potential revenue from existing and future
collaborations will likely consist of contingent payments, such
as payments for achieving development or regulatory milestones
and royalties payable on the sales of approved products. The
milestone and royalty revenues that we may receive under these
collaborations will depend primarily upon our
collaborators ability to successfully develop and
commercialize our product candidates. In addition, our
collaborators may decide to enter into arrangements with third
parties to commercialize products developed under our existing
or future collaborations using our technologies, which could
reduce the milestone and royalty revenue that we may receive, if
any. In many cases, we will not be directly involved in the
development or commercialization of our product candidates and,
accordingly, will depend entirely on our collaborators. Our
collaboration partners may fail to develop or effectively
commercialize our product candidates because they:
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do not allocate the necessary resources due to internal
constraints, such as limited personnel with the requisite
scientific expertise, limited capital resources, or the belief
that other product candidates or other internal programs may
have a higher likelihood of obtaining regulatory approval or may
potentially generate a greater return on investment;
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do not have sufficient resources necessary to fully support the
product candidate through clinical development, regulatory
approval and commercialization;
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are unable to obtain the necessary regulatory approvals;
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re-evaluate the importance and their support for developing our
product candidate pipeline due to a change in management,
business operations or financial strategy.
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In addition, a collaborator may decide to pursue the development
of a competitive product candidate developed outside of our
collaboration with them. Conflicts may also arise if there is a
dispute about the progress of, or other activities related to,
the clinical development or commercialization of a product
candidate, the achievement and payment of a milestone amount,
the ownership of intellectual property that is developed during
the course of the collaborative arrangement, or other licensing
agreement terms. If a collaboration partner fails to develop or
effectively commercialize our product candidates for any of
these reasons, we may not be able to replace them with another
partner willing to develop and commercialize our
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product candidates under similar terms, if at all. Similarly, we
may disagree with a collaborator as to which party owns newly or
jointly-developed intellectual property. Should an agreement be
revised or terminated as a result of a dispute and before we
have realized the anticipated benefits of the collaboration, we
may not be able to obtain certain development support or
revenues that we anticipated receiving. We may also be unable to
obtain, on terms acceptable to us, a license from such
collaboration partner to any of its intellectual property that
may be necessary or useful for us to continue to develop and
commercialize the product candidate. We cannot assure you that
any product candidates will emerge from our relationships with
Pfizer or any other future collaboration agreements we may enter
into for any of our product candidates.
If we
are unable to adequately protect or expand our intellectual
property related to our current or future product candidates,
our business prospects could be harmed.
Our success depends in part on our ability to:
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obtain and maintain intellectual property rights;
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protect our trade secrets; and
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prevent others from infringing on our proprietary rights or
patents.
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We will be able to protect our proprietary intellectual property
rights from unauthorized use by third parties only to the extent
that our proprietary rights are covered by valid and enforceable
patents or are effectively maintained as trade secrets. The
patent position of pharmaceutical and biopharmaceutical
companies involves complex legal and factual questions, and,
therefore, we cannot predict with certainty whether we will be
able to ultimately enforce our patents or proprietary rights.
Therefore, any issued patents that we own or otherwise have
intellectual property rights to may be challenged, invalidated
or circumvented, and may not provide us with the protection
against competitors that we anticipate.
The degree of future protection for our proprietary intellectual
property rights is uncertain because issued patents and other
legal means afford only limited protection and may not
adequately protect our rights or permit us to gain or keep our
competitive advantage. Our future patent position will be
influenced by the following factors:
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we or our licensors may not have been the first to discover the
inventions covered by each of our or our licensors pending
patent applications and issued patents, and we may have to
engage in expensive and protracted interference proceedings to
determine priority of invention;
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our or our licensors pending patent applications may not
result in issued patents;
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our or our licensors issued patents may not provide a
basis for commercially viable products, may not provide us with
any competitive advantages, or may be challenged by third
parties; and
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third parties may develop intellectual property around our or
our licensors patent claims to design competitive
intellectual property and ultimately product candidates that
fall outside the scope of our or our licensors patents.
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Because of the extensive time required for the development,
testing and regulatory review and approval of a product
candidate, it is possible that before any of our product
candidates can be approved for sale and commercialized, our
relevant patent rights may expire, or such patent rights may
remain in force for only a short period following approval and
commercialization. Patent expiration could adversely affect our
ability to protect future product development and, consequently,
our operating results and financial position. Also, patent
rights may not provide us with adequate proprietary protection
or competitive advantages against competitors with similar
technologies. The laws of certain foreign countries do not
protect our intellectual property rights to the same extent as
do the laws of the U.S. and those countries may lack
adequate rules and procedures for defending our intellectual
property rights. For example, we may not be able to prevent a
third party from infringing our patents in a country that does
not recognize or enforce patent rights, or that imposes
compulsory licenses on or restricts the prices of life-saving
drugs. Changes in either patent laws or in interpretations of
patent laws in the U.S. and other countries may diminish
the value of our intellectual property.
We may not develop or obtain rights to products or processes
that are patentable. Even if we or our licensors do obtain
patents, such patents may not adequately protect the products or
technologies we own or have
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licensed, or otherwise be limited in scope. In addition, we may
not have total control over the patent prosecution of subject
matter that we license from others. Accordingly, we may be
unable to exercise the same degree of control over this
intellectual property as we would over our own. Others may
challenge, seek to invalidate, infringe or circumvent any
pending or issued patents we own or license, and rights we
receive under those issued patents may not provide competitive
advantages to us. We cannot assure you as to the degree of
protection that will be afforded by any of our issued or pending
patents, or those licensed by us.
If a
third party claims we are infringing on its intellectual
property rights, we could incur significant expenses, or be
prevented from further developing or commercializing our product
candidates.
Our success will also depend on our ability to operate without
infringing the patents and other proprietary intellectual
property rights of third parties. This is generally referred to
as having the freedom to operate. The biotechnology
and pharmaceutical industries are characterized by extensive
litigation regarding patents and other intellectual property
rights. The defense and prosecution of intellectual property
claims interference proceedings and related legal and
administrative proceedings, both in the U.S. and
internationally, involve complex legal and factual questions. As
a result, such proceedings are lengthy, costly and
time-consuming and their outcome is highly uncertain. We may
become involved in protracted and expensive litigation in order
to determine the enforceability, scope and validity of the
proprietary rights of others, or to determine whether we have
the freedom to operate with respect to the intellectual property
rights of others.
Patent applications in the U.S. are, in most cases,
maintained in secrecy until approximately 18 months after
the patent application is filed. The publication of discoveries
in the scientific or patent literature frequently occurs
substantially later than the date on which the underlying
discoveries were made. Therefore, patent applications relating
to products similar to our product candidates may have already
been filed by others without our knowledge. In the event that a
third party has also filed a patent application covering our
product candidate or other claims, we may have to participate in
an adversarial proceeding, known as an interference proceeding,
in the U.S. Patent and Trademark Officer, or the USPTO, or
similar proceedings in other countries, to determine the
priority of invention. In the event an infringement claim is
brought against us, we may be required to pay substantial legal
fees and other expenses to defend such a claim and, if we are
unsuccessful in defending the claim, we may be prevented from
pursuing the development and commercialization of a product
candidate and may be subject to injunctions
and/or
damage awards.
We are aware of other companies that have filed patent
applications with respect to other nucleotide polymerase
inhibitors to treat chronic hepatitis C in the
U.S. and other countries. In the future, the USPTO or a
foreign patent office may grant patent rights to our product
candidates or other claims to third parties. Subject to the
issuance of these future patents, the claims of which will be
unknown until issued, we may need to obtain a license or
sublicense to these rights in order to have the appropriate
freedom to further develop or commercialize them. Any required
licenses may not be available to us on acceptable terms, if at
all. If we need to obtain such licenses or sublicenses, but are
unable to do so, we could encounter delays in the development of
our product candidates, or be prevented from developing,
manufacturing and commercializing our product candidates at all.
If it is determined that we have infringed an issued patent and
do not have the freedom to operate, we could be subject to
injunctions,
and/or
compelled to pay significant damages, including punitive
damages. In cases where we have in-licensed intellectual
property, our failure to comply with the terms and conditions of
such agreements could harm our business.
It is becoming common for third parties to challenge patent
claims on any successful product candidate or approved drug. If
we or our collaborators become involved in any patent
litigation, interference or other legal proceedings, we could
incur substantial expense, and the efforts of our technical and
management personnel will be significantly diverted. A negative
outcome of such litigation or proceedings may expose us to the
loss of our proprietary position or to significant liabilities,
or require us to seek licenses that may not be available from
third parties on commercially acceptable terms, if at all. We
may be restricted or prevented from developing, manufacturing
and selling our product candidates in the event of an adverse
determination in a judicial or administrative proceeding, or if
we fail to obtain necessary licenses.
We cannot be sure that any patents will be issued or that
patents licensed to us will be issued from any of our patent
applications or, should any patents issue, that we will be
provided with adequate protection against
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potentially competitive products. Furthermore, we cannot be sure
that patents issued or licensed to us will be of any commercial
value, or that private parties or competitors will not
successfully challenge these patents or circumvent our patent
position in the U.S. or abroad. In the absence of adequate
patent protection, our business may be adversely affected by
competitors who develop comparable technology or products.
Confidentiality
agreements with employees and others may not adequately prevent
disclosure of trade secrets and other proprietary information
and may not adequately protect our intellectual
property.
We rely on trade secrets to protect our technology, especially
where we do not believe patent protection is obtainable, or
prior to us filing patent applications on inventions we may make
from time to time. However, trade secrets are difficult to
protect. In order to protect our proprietary technology and
processes, we also rely in part on confidentiality and
intellectual property assignment agreements with our corporate
partners, employees, consultants, outside scientific
collaborators and sponsored researchers and other advisors.
These agreements may not effectively prevent disclosure of
confidential information nor result in the effective assignment
to us of intellectual property, and may not provide an adequate
remedy in the event of unauthorized disclosure of confidential
information or other breaches of the agreements. In addition,
others may independently discover our trade secrets and
proprietary information, and in such case we could not assert
any trade secret rights against such party. Enforcing a claim
that a third-party illegally obtained and is using our trade
secrets is difficult, expensive and time consuming, and the
outcome is unpredictable. In addition, courts outside the
U.S. may be less willing to protect trade secrets. Costly
and time-consuming litigation could be necessary to seek to
enforce and determine the scope of our proprietary rights, and
failure to obtain or maintain trade secret protection could
adversely affect our competitive business position.
Risks
Related to Owning Our Common Stock
We
have experienced operating losses since our inception. We expect
to continue to incur such losses for the foreseeable future and
we may never become profitable.
Since inception (May 13, 1994) and through
December 31, 2010, we have incurred a cumulative deficit of
approximately $268 million. Our losses to date have
resulted principally from:
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costs related to supporting our research programs and the
preclinical and clinical development of our product
candidates; and
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general and administrative costs relating to supporting our
operations.
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We anticipate incurring losses from operations for the
foreseeable future, as we plan to continue to conduct research,
preclinical studies and conduct extensive and expensive clinical
trials for our product candidates. We cannot assure you that we
will ever generate direct or royalty revenue from the sale of
products, or ever become profitable.
Our
revenues, expenses and results of operations may be subject to
significant fluctuations, which will make it difficult to
compare our operating results from period to
period.
Until we, or a collaborator, have successfully developed one of
our product candidates, we expect that substantially all of our
revenue will result from payments we receive under collaborative
arrangements or license agreements where we grant others the
right to use our intellectual property or know-how. We may not
be able to generate additional revenues under existing or future
collaborative agreements. Furthermore, payments potentially due
to us under our existing or any future collaborative
arrangements, including any milestone and up-front payments, are
intermittent in nature and are subject to significant
fluctuation in both timing and amount, or may never be earned or
paid. Further, our existing collaboration arrangement and most
likely, any future collaborations allow our partner to terminate
the agreement on relatively short notice. Our quarterly and
annual operating costs and revenues may become highly volatile,
and comparisons to previous periods may be difficult to make.
Therefore, our historical and current revenues may not be
indicative of our ability to achieve additional
payment-generating milestones or events in the future. We expect
that our operating results will also vary significantly from
quarter to quarter and year to year as a result of the
initiation, success or failure of preclinical studies or
clinical trials, the timing of the formulation and manufacture
of our product candidates, or other development related factors.
Accordingly, our revenues and
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results of operations for any period may not be comparable to
the revenues or results of operations for any other period.
The
reporting requirements of being a publicly-traded company
increase our overall operating costs and subject us to increased
regulatory risk.
As a publicly-traded company in the U.S., we are subject to the
reporting requirements of the Securities Exchange Act of 1934,
as amended, or the Exchange Act, the Sarbanes-Oxley Act of 2002,
or the Sarbanes-Oxley Act, and the listing requirements of the
NASDAQ Stock Market LLC. Section 404 of the Sarbanes-Oxley
Act requires that we maintain effective internal control over
financial reporting and disclosure controls and procedures. In
particular, we must perform system and process evaluation and
testing of our internal control over financial reporting to
allow management to assess the effectiveness of our internal
control over financial reporting and our independent auditor
will perform their own assessment on our internal control over
financial reporting. This testing is expensive and requires the
attention of our limited management resources. The various
financial reporting, legal, corporate governance and other
obligations associated with being a publicly-traded company
require us to incur significant expenditures and place
additional demands on our board of directors and executive
officers, as well as other administrative, operational, and
financial resources. If we are unable to comply with these
requirements in a timely and effective manner, we
and/or
our
executive officers may be subject to sanctions by the SEC, and
our ability to raise additional funds in the future maybe
impaired and ultimately affects our business. We will continue
to incur additional expenses as a result of being a
publicly-traded company.
In order to develop our product candidates and support our
operations beyond 15 months from December 31, 2010 and
continue as a going concern, we expect that we will need to
raise additional capital. Such capital may not be available to
us on acceptable terms, if at all, which could materially harm
our business and business prospects.
We anticipate that our existing cash and cash equivalents and
short-term investments on hand as of December 31, 2010,
together with proceeds we expect to receive from our existing
license and collaboration agreement will enable us to operate
for approximately 15 months. This estimate does not include
the direct costs associated with continuing the clinical
development of INX-189 beyond the recently-completed Phase 1b
clinical trial or FV-100 beyond the recently completed Phase 2
trial or the impact of any other significant transaction or
change in strategy or development plans in the future. We
currently do not have any commitments for future funding, nor do
we anticipate that we will generate significant revenue from the
sale of any products in the foreseeable future. Therefore, in
order to meet our anticipated liquidity needs beyond
15 months to continue the development of our product
candidates, or possibly sooner in the event we enter into other
transactions or change our strategy or accelerate our
development plans, we will need to secure additional capital. If
we do not raise additional capital in the short term and
continue with our development plans our liquidity guidance may
be less than 15 months. We would expect to fund the company
primarily through the sale of additional common stock or other
equity securities, as well as through proceeds from licensing
agreements, strategic collaborations, forms of debt financing,
or any other financing vehicle. Funds from these sources may not
be available to us on acceptable terms, if at all, and our
failure to raise such funds could have a material adverse impact
on our future business strategy, plans, financial condition and
results of operations. If adequate funds are not available to us
on acceptable terms in the future, we may be required to delay,
reduce the scope of, or eliminate one or more of our research
and development programs, or delay or curtail our preclinical
studies and clinical trials. If additional capital is not
available to us on acceptable terms, we may need to obtain funds
through license agreements, or collaborative or partner
arrangements pursuant to which we will likely relinquish rights
to certain product candidates that we might otherwise choose to
develop or commercialize independently, or be forced to enter
into such arrangements earlier than we would prefer, which would
likely result in less favorable transaction terms. Additional
equity financings may be dilutive to holders of our common
stock, and debt financing, if available, may involve significant
payment obligations and restrictive covenants that restrict how
we operate our business.
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The timing and extent of our future financing needs will depend
on many factors, some of which are very difficult to predict and
others that may be beyond our control, including:
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our clinical development plans for INX-189, FV-100 and any of
our product candidates, or any changes in our strategy;
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the variability, timing and costs associated with conducting
clinical trials, the rate of enrollment in such clinical trials
and the results of these clinical trials;
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the variability, timing and costs associated with conducting
preclinical studies, and the results of these studies;
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the cost of formulating and manufacturing preclinical and
clinical trial materials to evaluate our product candidates;
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whether we receive regulatory approval to advance the clinical
development of our product candidates in a timely manner, if at
all;
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the cost and time to obtain regulatory approvals required to
advance the development of our product candidates;
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the scope and size of our research and development efforts;
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the terms and timing of any collaborative, licensing and other
arrangements that we may establish in the future;
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future payments we may receive or make under existing or future
license or collaboration agreements, if any;
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the cost to maintain a corporate infrastructure to support being
a publicly-traded company; and
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the cost of filing, prosecuting, and enforcing patent and other
intellectual property claims.
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The
price of our common stock price has been highly volatile, and
your investment in us could suffer a decline in
value.
The market price of our common stock has been highly volatile
since the completion of our initial public offering in June
2004. The market price of our common stock is likely to continue
to be highly volatile and could be subject to wide fluctuations
in response to various factors and events, including but not
limited to:
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our ability to successfully advance our product candidates
through preclinical and clinical development;
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disclosure of any favorable or unfavorable data from our
preclinical studies or clinical trials, or other regulatory
developments concerning our clinical trials, the formulation and
manufacturing of our product candidates, or those of our
competitors;
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our ability to manage our cash burn rate at an acceptable or
planned level;
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the approval or commercialization of new products by us or our
competitors, and the disclosure thereof;
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announcements of scientific innovations by us or our competitors;
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rumors relating to us or our competitors;
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public concern about the safety of our product candidates, or
similar classes of compounds;
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litigation to which we may become subject;
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actual or anticipated variations in our annual and quarterly
operating results;
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changes in general conditions or trends in the biotechnology and
pharmaceutical industries;
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changes in drug reimbursement rates or government policies
related to such reimbursement;
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announcements by us or our competitors of significant
acquisitions, strategic partnerships, joint ventures or capital
commitments;
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new regulatory legislation adopted in the U.S. or abroad;
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changes in patent legislation in the U.S. or abroad;
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our failure to achieve or meet equity research analysts
expectations or their estimates of our business or prospects, or
a change in their recommendations concerning us, the value of
our common stock or our industry in general;
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termination or delay in any of our existing or future
collaborative arrangements;
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future sales of equity or debt securities, or the perception
that such future sales may occur;
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the sale of shares held by our directors or management;
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S-24
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the loss of our eligibility to have shares of our common stock
traded on the NASDAQ Capital Market due to our failure to
maintain minimum listing standards or other listed markets;
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changes in accounting principles;
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failure to comply with the periodic reporting requirements of
publicly-owned companies under the Exchange Act and the
Sarbanes-Oxley Act; and
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general economic conditions and capital markets.
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In addition, the stock market in general, and more specifically
the NASDAQ Capital Market, upon which our common stock trades,
and the market for smaller biotechnology stocks in particular
have historically experienced significant price and volume
fluctuations. Volatility in the market price for a particular
biotechnology companys stock has often been unrelated or
disproportionate to the operating performance of that company.
Market and industry factors may seriously harm the market price
of our common stock, regardless of our operating performance.
Due to this volatility, investors may be unable to sell their
shares of our common stock at or above the price they paid,
which could generate losses.
Future
issuances of shares of our common stock may cause our stock
price to decline, even if our business is doing
well.
The issuance of a significant number of shares of our common
stock, or the perception that such future sales could occur,
including sales by our directors, executive officers, and other
insiders or their affiliates, could materially and adversely
affect the market price of our common stock and impair our
ability to raise capital through the sale of additional equity
securities at a price we deem appropriate.
If we
raise additional capital in the future, your ownership in us
could be diluted or require us to relinquish
rights.
Any issuance of equity we may undertake in the future to raise
additional capital could cause the price of our common stock to
decline, or require us to issue shares at a price that is lower
than that paid by holders of our common stock in the past, which
would result in those newly issued shares being dilutive. If we
obtain funds through a debt financing or through the issuance of
debt or preferred securities, these securities would likely have
rights senior to your rights as a common stockholder, which
could impair the value of our common stock. Any debt financing
we enter into may include covenants that limit our flexibility
in conducting our business. We also could be required to seek
funds through arrangements with collaborators or others, which
might require us to relinquish valuable rights to our
intellectual property or product candidates that we would have
otherwise retained.
Insiders
and affiliates continue to have substantial control over us,
which could delay or prevent a change in control.
As of December 31, 2010, our directors and executive
officers, together with their affiliates, beneficially owned, in
the aggregate, approximately 25.1% of the outstanding shares of
our common stock. As a result, these stockholders, acting
together, may have the ability to delay or prevent a change in
control that may be favored by other stockholders and otherwise
exercise significant influence over all corporate actions
requiring stockholder approval, irrespective of how our other
stockholders may vote, including:
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the appointment of directors;
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the appointment, change or termination of management;
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any amendment of our certificate of incorporation or bylaws;
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the approval of acquisitions or mergers and other significant
corporate transactions, including a sale of substantially all of
our assets; and
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the defeat of any non-negotiated takeover attempt that might
otherwise benefit the public stockholders.
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A
significant number of shares of our common stock are subject to
issuance upon exercise of outstanding warrants, which upon such
exercise could result in dilution to our security
holders.
As of December 31, 2010, there were outstanding warrants to
purchase an aggregate of 12,868,100 shares of our common
stock. These warrants had a weighted average exercise price of
$1.14. The exercise price
and/or
S-25
the number of shares issuable upon exercise of our outstanding
warrants may be adjusted in certain circumstances and subject to
certain limitations, including upon the occurrence of certain
reclassifications or mergers or certain subdivisions or
combinations of the common stock, and the issuance of certain
stock dividends. Although we cannot determine at this time which
of these warrants may ultimately be exercised, it is reasonable
to assume that a warrant may be exercised if the exercise price
thereof is below the market price of our common stock at the
time of exercise. To the extent any of our outstanding warrants
are exercised in the future, additional shares of our common
stock will be issued that will be eligible for resale in the
public market, which could result in dilution to our security
holders. The issuance of additional securities upon the exercise
of warrants could also have an adverse effect on the market
price of our common stock.
We do
not anticipate paying cash dividends in the foreseeable future,
and accordingly, stockholders must rely on appreciation in the
price of our common stock for any return on their investment in
us.
We anticipate that we will retain our earnings, if any, for
future growth and therefore do not anticipate paying cash
dividends in the future. As a result, only appreciation in the
price of our common stock will provide a return to stockholders.
Our
amended and restated certificate of incorporation, our amended
and restated bylaws, as well as Delaware law contain provisions
that could discourage, delay or prevent a change in our control
or our management.
Provisions of our amended and restated certificate of
incorporation, bylaws and the laws of Delaware, the state in
which we are incorporated, may discourage, delay or prevent a
change in control of us or a change in management that
stockholders may consider favorable. These provisions:
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establish a classified, or staggered, Board of Directors so that
not all members of our board may be elected at one time;
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set limitations on the removal of directors;
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limit who may call a special meeting of stockholders;
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establish advance notice requirements for nominations for
election to our Board of Directors or for proposing matters that
can be acted upon at stockholder meetings;
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prohibit stockholder action by written consent, thereby
requiring all stockholder actions to be taken at a meeting of
our stockholders; and
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provide our Board of Directors with the ability to designate the
terms of and issue a new series of preferred stock without
stockholder approval.
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These provisions could discourage proxy contests and make it
more difficult for you and other stockholders to remove and
elect directors and take other corporate actions. These
provisions could also limit the price that investors might be
willing to pay in the future for shares of our common stock.
S-26
USE OF
PROCEEDS
We expect the net proceeds from this offering to be
approximately $ million, or
approximately $ million if
the underwriters exercise in full their over-allotment option to
purchase additional shares of common stock, after deducting the
estimated underwriting discounts and commissions and estimated
offering expenses payable by us.
We currently intend to use the net proceeds we receive from the
sale of the shares in this offering for working capital and
general corporate purposes, including a Phase 2 clinical trial
for INX-189, and research and development expenses related to
our other development programs. Pending such uses, the net
proceeds will be held in highly liquid investments.
This expected use of net proceeds of this offering represents
our current intentions based upon our present plans and business
conditions. As of the date of this prospectus supplement, we
cannot specify with certainty all of the particular uses for the
net proceeds to be received upon the completion of this
offering. Accordingly, our management will have broad discretion
in the application of the net proceeds, and investors will be
relying on the judgment of our management regarding the
application of the proceeds of this offering.
The amount and timing of our expenditures will depend on several
factors, including the progress of our research and development
efforts and the amount of cash used by our operations. Pending
their uses, we plan to invest the net proceeds of this offering
in short-term, investment-grade securities.
S-27
DILUTION
If you invest in our common stock in this offering, your
ownership interest will be diluted to the extent of the
difference between the public offering price per share and the
pro forma net tangible book value per share of our common stock
after this offering. Our net tangible book value on
December 31, 2010 was approximately $13.8 million, or
approximately $0.22 per share of common stock based upon
62,423,358 shares outstanding. Net tangible book value per
share is determined by dividing our net tangible book value,
which consists of tangible assets less total liabilities, by the
number of shares of our common stock outstanding on that date.
Without taking into account any other changes in our net
tangible book value after December 31, 2010, other than to
give effect to our receipt of the estimated net proceeds from
the sale
of shares
at an offering price of $ per
share, less the underwriting fees and our estimated offering
expenses, our net tangible book value as of December 31,
2010, after giving effect to the items above, would have been
approximately $ million, or
$ per share. This represents an
immediate increase in net tangible book value of
$ per share of common stock to our
existing shareholders and an immediate dilution in net tangible
book value of $ per share of
common stock to purchasers of shares in this offering. The
following table illustrates this calculation on a per share
basis:
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Public offering price per share
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$
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Net tangible book value per share as of December 31, 2010
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$
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0.22
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Increase in net tangible book value per share attributable to
the offering
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As-adjusted net tangible book value per share after giving
effect to the offering
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Dilution in net tangible book value per share to new investors
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$
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If the underwriters exercise in full their over-allotment option
to
purchase additional
shares of common stock in this offering, our net tangible book
value per share after the offering would be
$ per share, the increase in the
net tangible book value per share to existing stockholders would
be $ per share and the dilution to
new investors purchasing common stock in this offering would be
$ per share at the public offering
price.
The foregoing discussion excludes the following, each stated as
of December 31, 2010:
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6,860,800 shares of common stock issuable upon the exercise
of stock options outstanding as of December 31, 2010 at a
weighted average exercise price of $1.84 per share;
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1,934,048 shares of common stock reserved for future
issuance under our equity incentive plans as of
December 31, 2010; and
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12,868,100 shares of common stock issuable upon exercise of
warrants outstanding as of December 31, 2010 at a weighted
average exercise price of $1.14 per share with expiration dates
ranging from May 12, 2011 to September 26, 2018.
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S-28
UNDERWRITING
We have entered into an underwriting agreement with Deutsche
Bank Securities Inc., as representative of the underwriters
named below, with respect to the common stock subject to this
offering. Subject to the terms and conditions of the
underwriting agreement, the underwriters have severally agreed
to purchase from us the number of shares of common stock listed
next to each underwriters name below at a public offering
price less the applicable underwriting discounts and commissions
set forth on the cover page of this prospectus supplement.
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Number
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Underwriter
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of Shares
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Deutsche Bank Securities Inc
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Total
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The underwriting agreement provides that the obligations of the
several underwriters to purchase the shares of common stock
offered hereby are subject to certain conditions precedent and
that the underwriters will purchase all of the shares of common
stock offered by this prospectus supplement, other than those
covered by the over-allotment option described below, if any of
these shares are purchased.
We have been advised by the underwriters that the underwriters
propose to
offer
of the shares of common stock to the public at the public
offering price set forth on the cover of this prospectus
supplement and to dealers at a price that represents a
concession not in excess of $ per
share under the public offering price. The underwriters may
allow, and these dealers may re-allow, a concession of not more
than $ per share to other dealers.
After the initial public offering, the underwriters may change
the offering price and other selling terms.
We have granted to the underwriters an option, exercisable not
later than 30 days after the date of this prospectus
supplement, to purchase a number of additional shares of common
stock equal to fifteen percent (15%) of this offering. The price
for such additional shares shall be the public offering price
less the underwriting discounts and commissions set forth on the
cover page of this prospectus supplement. The underwriters may
exercise this option only to cover over-allotments made in
connection with the sale of the common stock offered by this
prospectus supplement. To the extent that the underwriters
exercise their option, the underwriters will become obligated,
subject to conditions, to purchase such additional shares of
common stock. We will be obligated, pursuant to the option, to
sell these additional shares of common stock to the underwriters
to the extent the option is exercised. If any shares are
purchased with this over-allotment option, the underwriters will
purchase shares in approximately the same proportion as shown in
the table above.
The underwriting discounts and commissions per share are equal
to the public offering price per share of common stock less the
amount paid by the underwriters to us per share of common stock.
The underwriting discounts and commissions
are % of the initial public
offering price, subject to the provisions described above. We
have agreed to pay the underwriters the following discounts and
commissions, assuming either no exercise or full exercise by the
underwriters of their over-allotment option, as follows:
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Total Fees
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Without
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With Full
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Exercise of
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Exercise of
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Over-
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Over-
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Fee per
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Allotment
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Allotment
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share
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Option
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Option
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Discounts and commissions paid by us
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$
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$
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$
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We have agreed to pay Trout Capital LLC a financial advisory fee
equal to $100,000, which amount will reduce the total
underwriting discounts to be paid to the underwriters.
S-29
We estimate that our share of the total expenses of this
offering, excluding underwriting discounts and commissions, will
be approximately $ .
We have agreed to indemnify the underwriters against some
specified types of liabilities, including liabilities under the
Securities Act, and to contribute to payments the underwriters
may be required to make in respect of any of these liabilities.
Each of our officers and directors have agreed not to offer,
sell, contract to sell or otherwise dispose of, or enter into
any transaction that is designed to, or could be expected to,
result in the disposition of any shares of our common stock or
other securities convertible into or exchangeable or exercisable
for shares of our common stock or derivatives of our common
stock owned by these persons prior to this offering or common
stock issuable upon exercise of options or warrants held by
these persons for a period of 60 days after the date of
this prospectus supplement without the prior written consent of
Deutsche Bank Securities Inc. This consent may be given at any
time without public notice. Transfers or dispositions can be
made during the
lock-up
period in the case of gifts or for estate planning purposes
where the donee signs a
lock-up
agreement. We have entered into a similar agreement with the
underwriters. There are no agreements between the underwriters
and any of our stockholders or affiliates releasing them from
these
lock-up
agreements prior to the expiration of the 60 day period
Notwithstanding the foregoing, if (1) during the last
17 days of the 60 day restricted period, we issue an
earnings release or material news or a material event relating
to us occurs; or (2) prior to the expiration of the
60 day restricted period, we announce that we will release
earnings results during the
16-day
period following the last day of the 60 day restricted
period, then in each case the restrictions described above will
continue to apply until the expiration of the
18-day
period beginning on the date of the release of the earnings
results or the occurrence of material news or a material event
relating to us (unless the extension is waived in writing by
Deutsche Bank Securities Inc.).
The underwriters have advised us that they do not intend to
confirm sales to any account over which they exercise
discretionary authority.
In connection with the offering, the underwriters may purchase
and sell shares of our common stock in the open market. These
transactions may include short sales, purchases to cover
positions created by short sales and stabilizing transactions.
Short sales involve the sale by the underwriters of a greater
number of shares than they are required to purchase in the
offering. Covered short sales are sales made in an amount not
greater than the underwriters option to purchase
additional shares of common stock from us in the offering. The
underwriters may close out any covered short position by either
exercising their option to purchase additional shares or
purchasing shares in the open market. In determining the source
of shares to close out the covered short position, the
underwriters will consider, among other things, the price of
shares available for purchase in the open market as compared to
the price at which they may purchase shares through the
over-allotment option.
Naked short sales are any sales in excess of the over-allotment
option. The underwriters must close out any naked short position
by purchasing shares in the open market. A naked short position
is more likely to be created if the underwriters are concerned
that there may be downward pressure on the price of the shares
in the open market prior to the completion of the offering.
Stabilizing transactions consist of various bids for or
purchases of our common stock made by the underwriters in the
open market prior to the completion of the offering.
Purchases to cover a short position and stabilizing transactions
may have the effect of preventing or slowing a decline in the
market price of our common stock. Additionally, these purchases
may stabilize, maintain or otherwise affect the market price of
our common stock. As a result, the price of our common stock may
be higher than the price that might otherwise exist in the open
market. These transactions may be effected on The NASDAQ Capital
Market, in the
over-the-counter
market or otherwise.
S-30
The underwriters or their affiliates have provided investment
banking services to us in the past and may do so in the future.
They receive customary fees and commissions for these services.
LEGAL
MATTERS
The validity of the securities offered hereby will be passed
upon for us by Dechert LLP, New York, New York. Certain legal
matters relating to the offering will be passed upon for the
underwriters by Goodwin Procter LLP, New York, New York.
EXPERTS
The consolidated financial statements of Inhibitex, Inc.
appearing in Inhibitex, Inc.s Annual Report
(Form 10-K)
for the year ended December 31, 2010, and the effectiveness
of Inhibitex, Inc.s internal control over financial
reporting as of December 31, 2010 have been audited by
Ernst & Young LLP, independent registered public
accounting firm, as set forth in their reports thereon, included
therein, and incorporated herein by reference. Such consolidated
financial statements are incorporated herein by reference in
reliance upon such reports given on the authority of such firm
as experts in accounting and auditing.
WHERE YOU
CAN FIND MORE INFORMATION
We are subject to the information requirements of the Exchange
Act and, in accordance therewith, file annual, quarterly and
special reports, proxy statements and other information with the
SEC. You may read and copy any document we file at the
SECs Public Reference Room at 100 F Street,
N.E., Washington, D.C. 20549. You may call the SEC at
1-800-SEC-0330
for further information on the operation of the Public Reference
Room. These documents also may be accessed through the
SECs electronic data gathering, analysis and retrieval
system, or EDGAR, via electronic means, including the SECs
home page on the Internet (www.sec.gov).
This prospectus supplement is part of a registration statement
we filed with the SEC relating to the securities we may offer.
As permitted by SEC rules, this prospectus supplement does not
contain all of the information we have included in the
registration statement and the accompanying exhibits and
schedules we filed with the SEC. You may refer to the
registration statement, exhibits and schedules for more
information about us and the securities. The registration
statement, exhibits and schedules are available at the
SECs public reference room or through its website.
INCORPORATION
BY REFERENCE
The SEC allows us to incorporate by reference the
information we have filed with it, which means that we can
disclose important information by referring you to those
documents. The information we incorporate by reference is an
important part of this prospectus supplement and the
accompanying prospectus, and later information that we file with
the SEC will automatically update and supersede this
information. We incorporate by reference into this prospectus
supplement and the accompanying prospectus the following
documents that we have filed with the SEC and all documents
filed with the SEC under Sections 13(a), 13(c), 14 or 15(d)
of the Exchange Act subsequent to the date of this prospectus
supplement and prior to the termination of the offering:
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our annual report on
Form 10-K
for the fiscal year ended December 31, 2010, filed with the
SEC on March 16, 2011;
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our current reports on
Form 8-K,
filed with the SEC on January 10, 2011; March 11,
2011; and March 31, 2011; and
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the description of our Common Stock and Preferred Stock
contained in the registration statement on
Form 8-A,
filed on May 21, 2004, and all amendments and reports
updating such description.
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S-31
Upon oral or written request and at no cost to the requester, we
will provide to any person, including a beneficial owner, to
whom a prospectus is delivered, a copy of any or all the
information that has been incorporated by reference in this
prospectus but not delivered with this prospectus. All requests
should be made to: Inhibitex, Inc., 9005 Westside Parkway,
Alpharetta, GA 30009, Attn: Corporate Secretary. You should rely
only on the information incorporated by reference or provided in
this prospectus. We have not authorized anyone to provide you
with different information. You should not assume that the
information in this prospectus or the documents incorporated by
reference is accurate as of any date other than the date on the
front of this prospectus or those documents.
S-32
PROSPECTUS
$100,000,000
Common Stock
Preferred Stock
Warrants
Rights
Debt Securities
Units
We may issue, from time to time at prices and on terms to be
determined at or prior to the time of the offering, up to
$100,000,000 of any combination of the securities described in
this prospectus, either individually or in units. This
prospectus describes the general terms of these securities and
the general manner in which these securities will be offered. We
will provide you with specific terms of any offering in one or
more supplements to this prospectus. The prospectus supplements
will also describe the specific manner in which these securities
will be offered and may also supplement, update or amend
information contained in this document. You should carefully
read this prospectus and any prospectus supplement, as well as
any documents incorporated by reference into this prospectus or
any prospectus supplement, before you invest. Our securities may
be sold directly by us to you, through agents designated from
time to time or to or through underwriters or dealers. For
additional information on the methods of sale, you should refer
to the section entitled Plan of Distribution in this
prospectus and in the applicable prospectus supplement. If any
underwriters or agents are involved in the sale of our
securities with respect to which this prospectus is being
delivered, the names of such underwriters or agents and any
applicable fees, commissions or discounts and over-allotment
options will be set forth in a prospectus supplement. The price
to the public of such securities and the net proceeds that we
expect to receive from such sale will also be set forth in a
prospectus supplement.
Our Common Stock is quoted on the NASDAQ Capital Market under
the symbol INHX. On May 4, 2010, the last
reported sale price for our Common Stock was $2.69.
This prospectus may not be used to consummate sales of
securities unless accompanied by a prospectus supplement.
Investing in our securities involves a high degree of risk.
See Risk Factors beginning on Page 5 for
information that you should consider before investing in our
securities.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or passed upon the adequacy or accuracy of this
prospectus. Any representation to the contrary is a criminal
offense.
The date of this prospectus is
May 6, 2010
TABLE OF
CONTENTS
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2
ABOUT
THIS PROSPECTUS
This prospectus is part of a registration statement that we
filed with the Securities and Exchange Commission, or SEC,
utilizing a shelf registration process. Under this
shelf registration process, we may offer shares of our common
stock and preferred stock, various series of debt securities
and/or
warrants, or rights to purchase any of such securities, either
individually or in units, in one or more offerings, with a total
value of up to $100,000,000. This prospectus provides you with a
general description of the securities we may offer. Each time we
offer a type or series of securities under this prospectus, we
will provide a prospectus supplement that will contain specific
information about the terms of that offering. The prospectus
supplement may also add, update or change information contained
in this prospectus. You should carefully read both this
prospectus and any prospectus supplement together with
additional information described under the heading WHERE
YOU CAN FIND MORE INFORMATION before making an investment
decision.
We have not authorized any person to give any information or to
make any representation in connection with this offering other
than those contained or incorporated by reference in this
prospectus, and, if given or made, such information or
representation must not be relied upon as having been so
authorized. This prospectus does not constitute an offer to sell
or a solicitation of an offer to buy by anyone in any
jurisdiction in which such offer to sell is not authorized, or
in which the person is not qualified to do so or to any person
to whom it is unlawful to make such offer or solicitation.
Neither the delivery of this prospectus and the accompanying
prospectus supplement, nor any sale hereunder and thereunder
shall, under any circumstances, create any implication that
there has been no change in our affairs subsequent to the date
set forth on the front of such document, that the information
contained herein and the accompanying prospectus supplement is
correct as of any time subsequent to the date set forth on the
front of such document, or that any information incorporated by
reference is correct as of any time subsequent to the date set
forth on the front of such document.
Any statement made in this prospectus or in a document
incorporated or deemed to be incorporated by reference in this
prospectus will be deemed to be modified or superseded for
purposes of this prospectus to the extent that a statement
contained in any prospectus supplement or in any other
subsequently filed document that is also incorporated or deemed
to be incorporated by reference in this prospectus modifies or
supersedes that statement. Any statement so modified or
superseded will not be deemed, except as so modified or
superseded, to constitute a part of this prospectus. See
Incorporation of Certain Documents by Reference in
this prospectus.
Unless otherwise specified, references in this prospectus to
Inhibitex, the Company, we,
our and us refer to Inhibitex, Inc.
3
ABOUT
INHIBITEX, INC.
We are a biopharmaceutical company focused on the development of
differentiated anti-infective products to prevent or treat
serious infections. Our research and development efforts are
currently focused on small molecule antiviral compounds, and in
particular, orally-available therapies to treat herpes zoster,
or shingles, and chronic infections caused by hepatitis C
virus, or HCV. Currently available antiviral therapies have a
number of therapeutic limitations that include inadequate
potency, significant adverse side effects, complex dosing
schedules, inconvenient methods of administration, and
diminishing efficacy due to the emergence of drug-resistant
viruses. We believe that our antiviral drug candidates have the
potential to address a number of these limitations as well as
unmet clinical needs in their respective intended indications.
In addition to our antiviral programs, we have also licensed the
rights to certain intellectual property from our MSCRAMM protein
platform to Pfizer Inc. for the development of active vaccines
to prevent staphylococcal infections.
Our lead product candidate, FV-100, is an orally available
nucleoside analogue prodrug being developed for the treatment of
herpes zoster, which is caused by varicella zoster virus. We
have initiated a Phase II clinical trial of FV-100. The
Phase II trial is a well-controlled, double-blind study
comparing two arms of FV-100 to an active control (valacyclovir).
Our preclinical pipeline includes INX-189, the lead compound
from our series of nucleotide polymerase inhibitors, or
protides, which we are developing to treat infections caused by
HCV. We have completed the requisite good laboratory practices
preclinical studies needed to support the filing of an
investigational new drug application, or IND, for INX-189 with
the United States Food and Drug Administration, or FDA. We
anticipate filing an IND for INX-189 shortly, and subject to FDA
review, anticipate initiating a Phase I clinical trial of
INX-189 in the first half of 2010.
We have retained all worldwide rights to both FV-100 and INX-189
and intend to establish strategic collaborations, partnerships
and alliances that we believe can accelerate the development and
commercialization of our antiviral product candidates beyond
clinical proof of concept by utilizing the financial, clinical
development, manufacturing and commercialization capabilities of
a leading pharmaceutical company.
We have not received regulatory approval to sell or market any
of our current or past product candidates, nor do we have any
commercialization capabilities; therefore, it is possible that
we may never successfully derive any commercial revenues from
any of our existing or future product candidates.
Inhibitex
®
and
MSCRAMM
®
are registered trademarks of Inhibitex, Inc.
Corporate
Information
We were incorporated in Delaware in May 1994. Our principal
executive offices are located at 9005 Westside Parkway,
Alpharetta, Georgia 30009. Our telephone number is
(678) 746-1100.
Our website is
www.inhibitex.com
. Information contained
on our website is not incorporated by reference into and does
not constitute part of this prospectus.
4
RISK
FACTORS
Investing in our securities involves a high degree of risk.
Before making an investment decision, you should carefully
consider the specific risks set forth under the caption
Risk Factors in the applicable prospectus
supplement, and under the caption Risk Factors under
Item 1 of Part 1 of our Annual Report on
Form 10-K
for the fiscal year ended December 31, 2009, which is
incorporated by reference into this prospectus, and any other
document that is incorporated by reference into this prospectus
or the applicable prospectus supplement.
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus and the documents incorporated herein by
reference contain forward-looking statements. These
forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied
by the forward-looking statements. In some cases, you can
identify forward-looking statements by terms such as
may, will, should,
could, would, expect,
plan, intend, anticipate,
believe, estimate, project,
predict, forecast,
potential, likely or
possible, as well as the negative of such
expressions, and similar expressions intended to identify
forward-looking statements. There may be events in the future
that we are unable to predict accurately, or over which we have
no control. Before you purchase our securities, you should read
this prospectus and the documents that we reference or
incorporate by reference in this prospectus or registration
statement of which this prospectus is a part, completely and
with the understanding that our actual future results may be
materially different from what we expect. Our business,
financial condition, results of operations, and prospects may
change. We may not update these forward-looking statements, even
though our situation may change in the future, unless we have
obligations under the federal securities laws to update and
disclose material developments related to previously disclosed
information. We qualify all of the information presented or
incorporated by reference in this prospectus, and particularly
our forward-looking statements, by these cautionary statements
USE OF
PROCEEDS
Unless otherwise provided in the applicable prospectus
supplement, we intend to use the net proceeds from the sale of
the securities (including proceeds, if any, received from the
exercise of warrants sold by us) for general corporate purposes,
which may include the development and commercialization of our
product candidates, working capital, capital expenditures,
licensing rights to intellectual property and acquisitions of
other businesses, technologies and compounds. When any
particular securities are offered, the respective prospectus
supplement relating to that offering will set forth our intended
use of the net proceeds received from the sale of those
securities. Our management will have broad discretion in the
allocation of the net proceeds of the offering. Pending the
application of the net proceeds for these purposes, we expect to
invest such proceeds in short-term, interest-bearing instruments
or other investment-grade securities.
5
GENERAL
DESCRIPTION OF SECURITIES
We, directly or through agents, dealers or underwriters
designated from time to time, may offer, issue and sell,
together or separately, up to $100,000,000 aggregate offering
price of:
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shares of our common stock, par value $.001 per share; or
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shares of our preferred stock, par value $.001 per share; or
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Warrants to purchase our Common Stock, Preferred Stock
and/or
Debt
Securities; or
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Rights to purchase our Common Stock, Preferred Stock or other
Securities described herein; or
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Debt Securities; or
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any combination of the foregoing, either individually or as
units consisting of one or more of the foregoing, each on terms
to be determined at the time of sale.
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When any particular securities are offered, a supplement to this
prospectus will be delivered with this prospectus which will set
forth the terms of the offering and sale of the offered
securities as well as complete descriptions of the security or
securities to be offered pursuant to the prospectus supplement.
The summary descriptions of securities included in this
prospectus are not meant to be complete descriptions of each
security.
DESCRIPTION
OF CAPITAL STOCK
Our certificate of incorporation authorizes the issuance of up
to 150,000,000 shares of common stock, par value $.001 per
share, and up to 5,000,000 shares of preferred stock, par
value $.001 per share. As of March 25, 2010, we had
outstanding 61,562,606 shares of common stock and no shares
of preferred stock.
The following descriptions of our common stock and preferred
stock are qualified in their entirety by reference to our Eighth
Amended and Restated Certificate of Incorporation, as amended to
date, and our Amended and Restated By-laws. For information on
how to obtain copies of our Amended and Restated Certificate of
Incorporation, as amended to date, and our Amended and Restated
By-laws, see WHERE YOU CAN FIND MORE INFORMATION on
page 20 of this prospectus.
Common
Stock
Holders of our common stock are entitled to one vote for each
share held on all matters submitted to a vote of stockholders
and do not have cumulative voting rights. Accordingly, holders
of a majority of the shares of common stock entitled to vote in
any election of directors may elect all of the directors
standing for election. Holders of common stock are entitled to
receive proportionately any dividends as may be declared by our
board of directors, subject to any preferential dividend rights
of outstanding preferred stock.
In the event of our liquidation, dissolution or winding up, the
holders of common stock are entitled to proportionately receive
our net assets available for distribution after the payment of
all debts and other liabilities and subject to the prior rights
of any outstanding preferred stock. Holders of our common stock
have no preemptive, subscription, redemption or conversion
rights. The rights, preferences and privileges of holders of
common stock are
6
subject to, and may be adversely affected by, the rights of the
holders of shares of any series of preferred stock that we may
designate and issue in the future.
Preferred
Stock
Our certificate of incorporation authorizes us, without further
vote or action by the stockholders, to issue up to an aggregate
of 5,000,000 shares of preferred stock in one or more
series. Each series of preferred stock will have such number of
shares, designations, preferences, voting powers, qualifications
and special or relative rights or privileges as shall be
determined by our board of directors, which may include, among
others, dividend rights, voting rights, redemption and sinking
fund provisions, liquidation preferences, conversion rights and
pre-emptive rights.
The issuance of preferred stock, while providing desired
flexibility in connection with possible acquisitions and other
corporate purposes, could adversely affect the voting power or
other rights of the holders of common stock, and could make it
more difficult for a third party to acquire, or could discourage
a third party from attempting to acquire, a majority of our
outstanding voting stock. We cannot determine the actual impact
or effect of the issuance of any of this preferred stock upon
the rights of the holders of our common stock until the board
issues or determines the specific rights of this preferred stock.
Anti-Takeover
Effects or Provisions of Delaware Law and Our Amended and our
Charter Documents
We are subject to the provisions of Section 203 of the
Delaware General Corporation Law. Subject to certain exceptions,
Section 203 of the Delaware General Corporation Law
prohibits a publicly-held Delaware corporation, such as us, from
engaging in a business combination with an
interested stockholder for a period of three years
after the date of the transaction in which the person became an
interested stockholder, unless the interested stockholder
attained such status with the approval of our board of directors
or unless the business combination is approved in a prescribed
manner. A business combination is defined to include
a merger or asset sale involving the interested stockholder or
any other transaction resulting in a financial benefit to the
interested stockholder. Subject to various exceptions, an
interested stockholder is a person who, together
with affiliates and associates, owns, or within the past three
years did own, 15% or more of a corporations voting stock.
This statute could prohibit or delay the accomplishment of
mergers or other takeover or change in control attempts with
respect to us and, accordingly, may discourage attempts to
acquire us.
In addition, certain provisions of our amended and restated
certificate of incorporation and our amended and restated
by-laws may have the effect of delaying, deferring or preventing
a tender offer or takeover attempt that our stockholders might
deem to be in their best interests. These provisions are
designed to encourage persons seeking to acquire us to initiate
such a transaction through arms-length negotiations with
our board of directors. The existence of these provisions could
adversely affect the prevailing price of our common stock or
limit the price that others might be willing to pay in the
future for shares of our common stock. These provisions include:
Stockholder Action; Special Meeting of
Stockholders.
Stockholders may not take action by
written consent, but only at a duly called annual or special
meeting of our stockholders. Special meetings of our
stockholders may be called only by the chairman of our board of
directors, our chief executive officer, or a majority of our
board of directors, and in no event may stockholders call a
special meeting. Thus, without approval by the chairman of the
board of directors, our chief executive officer or a majority of
the board of directors, our stockholders may not take action
between annual meetings.
Advance Notice Requirements for Stockholder Proposals and
Director Nominations.
A stockholder seeking to bring
business before an annual meeting of our stockholders, or to
nominate candidates for election as directors at an annual
meeting of our stockholders, must provide timely notice of his
or her intention in writing. To be timely, a stockholders
notice must be delivered to our secretary, at our principal
executive offices, not less than 90 days nor more than
120 days prior to the first anniversary of the date of the
previous years annual meeting of our stockholders.
However, if no annual meeting of stockholders was held in the
previous year or the date of the annual meeting of stockholders
has been changed to be more than 30 calendar days from the time
of the
7
previous years annual meeting, then a proposal shall be
received no later than the close of business on the tenth day
following the date on which notice of the date of the meeting
was mailed or a public announcement was made. Only our board of
directors or a committee thereof may nominate candidates for
election at a special meeting of our stockholders. Our Amended
and Restated By-Laws also specify requirements as to the form
and content of a stockholders notice. These provisions may
preclude stockholders from bringing matters before an annual
meeting of our stockholders or from making nominations for
directors at an annual or special meeting of our stockholders.
Authorized but Unissued Shares.
Our authorized but
unissued shares of common and preferred stock are available for
future issuance without stockholder approval, subject to any
limitations imposed by the NASDAQ Capital Market. These
additional shares may be utilized for a variety of corporate
needs, including acquisitions and raising additional funds. The
existence of authorized but unissued and unreserved common and
preferred stock could discourage an attempt by third parties to
obtain control of us by means of a proxy contest, tender offer,
merger or otherwise.
Classification of Board Members.
Our board of
directors is classified into three different classes of members,
as nearly equal in size as possible, with each class having its
own three-year term. Any one or more, or all, of the directors
may be removed by the holders of at least a majority of the
shares then entitled to vote at an election of directors only
for cause. Any vacancy on our board of directors, including a
vacancy resulting from an enlargement of the board, may only be
filled by vote of a majority of the directors then in office.
This classification of our board of directors, and the
limitations on the removal of directors and filling of
vacancies, may have the effect of making it more difficult for a
third party to acquire control of us, or of discouraging a third
party from acquiring control of us because at least two annual
meetings of stockholders, instead of one, generally will be
required to change the majority of our board of directors.
Transfer
Agent and Registrar
American Stock Transfer & Trust Company is the
transfer agent and registrar for our common stock. The transfer
agent and registrar for any series of preferred stock will be
named and described in the prospectus supplement for that series.
DESCRIPTION
OF DEBT SECURITIES
The following description, together with the additional
information we include in any applicable prospectus supplement,
summarizes the material terms and provisions of the debt
securities that we may offer under this prospectus and the
related indenture. While the terms we have summarized below will
apply generally to any future debt securities we may offer
pursuant to this prospectus, we will describe the particular
terms of any debt securities that we may offer in more detail in
the applicable prospectus supplement. If we indicate in a
prospectus supplement, the terms of any debt securities we offer
under that prospectus supplement may differ from the terms we
describe below.
We may offer debt securities from time to time, in one or more
offerings under this prospectus. We will issue any such debt
securities under an indenture that we will enter into with a
trustee to be named in the indenture. We have filed a form of
indenture as an exhibit to the registration statement of which
this prospectus is a part. The indenture will be qualified under
the Trust Indenture Act of 1939, as in effect on the date
of the indenture. We use the term debenture trustee
to refer to the trustee under the indenture.
The following summaries of material provisions of the debt
securities and the indenture are subject to, and qualified in
their entirety by reference to, all the provisions of the
indenture applicable to a particular series of debt securities.
General
The indenture provides that debt securities may be issued from
time to time in one or more series. The indenture does not limit
the amount of debt securities that may be issued thereunder, and
the indenture
8
provides that the specific terms of any series of debt
securities shall be set forth in, or determined pursuant to, an
authorizing resolution, an officers certificate
and/or
a
supplemental indenture, if any, relating to such series.
We will describe in each prospectus supplement the following
terms relating to a series of debt securities:
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the title or designation of the debt securities;
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any limit upon the aggregate principal amount of the debt
securities;
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the date or dates on which debt securities may be issued and on
which we will pay the principal on the debt securities;
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the interest rate, which may be fixed or variable, or the method
for determining the rate and the date interest will begin to
accrue, the date or dates interest will be payable and the
record dates for interest payment dates or the method for
determining such dates;
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the manner in which the amounts of payment of principal of,
premium or interest on the debt securities will be determined,
if these amounts may be determined by reference to an index
based on a currency or currencies other than that in which the
debt securities are denominated or designated to be payable or
by reference to a commodity, commodity index, stock exchange
index or financial index;
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the currency of denomination of the debt securities;
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if payments of principal of, premium or interest on the debt
securities will be made in one or more currencies or currency
units other than that or those in which the debt securities are
denominated, the manner in which the exchange rate with respect
to these payments will be determined;
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the place or places where the principal of, premium, and
interest on the debt securities will be payable, where debt
securities of any series may be presented for registration of
transfer, exchange or conversion, and where notices and demands
to or upon the Company in respect of debt securities may be made;
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the terms and conditions upon which we may redeem the debt
securities;
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any obligation we have to redeem or purchase the debt securities
pursuant to any sinking fund or analogous provisions or at the
option of a holder of debt securities;
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the dates on which and the price or prices at which we will
repurchase the debt securities at the option of the holders of
debt securities and other detailed terms and provisions of these
repurchase obligations;
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the denominations in which the debt securities will be issued,
if other than denominations of $1,000 and any integral multiple
thereof;
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the portion of principal amount of the debt securities payable
upon declaration of acceleration of the maturity date, if other
than the principal amount;
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whether the debt securities are to be issued at any original
issuance discount and the amount of discount with which such
debt securities may be issued;
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whether the debt securities will be issued in the form of
certificated debt securities or global debt securities, and, in
such case, the depositary for such global security or securities
and the terms and conditions, if any, upon which interests in
such global security or securities may be exchanged in whole or
in part for the individual securities represented thereby;
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provisions, if any, for the defeasance of the debt securities of
a series in whole or in part and any additional change in the
provisions related to satisfaction and discharge;
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the form of the debt securities;
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the terms and conditions upon which the debt securities will be
so convertible or exchangeable into securities or property of
another person, if at all, and any additions or changes, if any,
to permit or facilitate such conversion or exchange;
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whether the debt securities will be subject to subordination and
the terms of such subordination;
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provisions, if any, granting special rights to holders of the
debt securities upon the occurrence of specified events;
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any restriction or condition on the transferability of the debt
securities;
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any addition or change in the provisions related to compensation
and reimbursement of the trustee which applies to Securities of
such series;
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any addition to or change in the events of default described in
this prospectus or in the indenture with respect to the debt
securities and any change in the acceleration provisions
described in this prospectus or in the indenture with respect to
the debt securities;
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any addition to or change in the covenants described in this
prospectus or in the indenture with respect to the debt
securities; and
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any other terms of the debt securities, which may modify or
delete any provision of the indenture.
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We may issue debt securities that provide for an amount less
than their stated principal amount to be due and payable upon
declaration of acceleration of their maturity pursuant to the
terms of the indenture. We will provide you with information on
the federal income tax considerations and other special
considerations applicable to any of these debt securities in the
applicable prospectus supplement.
Conversion
or Exchange Rights
We will set forth in the prospectus supplement the terms, if
any, on which a series of debt securities may be convertible
into or exchangeable for our common stock or our other
securities. We will include provisions as to whether conversion
or exchange is mandatory, at the option of the holder or at our
option. We may include provisions pursuant to which the number
of shares of our common stock or our other securities that the
holders of the series of debt securities receive would be
subject to adjustment.
Consolidation,
Merger or Sale; No Protection in Event of a Change of Control or
Highly Leveraged Transaction
The indenture provides that we may not merge or consolidate with
or into another entity, or sell other than for cash or lease all
or substantially all our assets to another entity, or purchase
all or substantially all the assets of another entity unless we
are the surviving entity or, if we are not the surviving entity,
the successor, transferee or lessee entity expressly assumes all
of our obligations under the indenture or the debt securities,
as appropriate.
Unless we state otherwise in the applicable prospectus
supplement, the debt securities will not contain any provisions
that may afford holders of the debt securities additional
protection in the event we have a change of control or in the
event of a highly leveraged transaction (whether or not such
transaction results in a change of control), which could
adversely affect holders of debt securities.
Events of
Default Under the Indenture
The following are events of default under the indenture with
respect to any series of debt securities that we may issue:
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if we fail to pay interest when due and our failure continues
for 90 days and the time for payment has not been extended
or deferred;
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if we fail to pay the principal, or premium, if any, when due
whether by maturity or called for redemption;
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if we fail to pay a sinking fund installment, if any, when due
and our failure continues for 30 days;
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if we fail to observe or perform any other covenant relating to
such series contained in the debt securities of such series or
the indenture, other than a covenant specifically relating to
and for the benefit of holders of another series of debt
securities, and our failure continues for 90 days after we
receive written notice from the debenture trustee or holders of
not less than a majority in aggregate principal amount of the
outstanding debt securities of the applicable series; and
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if specified events of bankruptcy, insolvency or reorganization
occur as to us.
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No event of default with respect to a particular series of debt
securities (except as to certain events of bankruptcy,
insolvency or reorganization) necessarily constitutes an event
of default with respect to any other series of debt securities.
The occurrence of an event of default may constitute an event of
default under any bank credit agreements we may have in
existence from time to time. In addition, the occurrence of
certain events of default or an acceleration under the indenture
may constitute an event of default under certain of our other
indebtedness outstanding from time to time.
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If an event of default with respect to debt securities of any
series at the time outstanding occurs and is continuing, then
the trustee or the holders of not less than a majority in
principal amount of the outstanding debt securities of that
series may, by a notice in writing to us (and to the debenture
trustee if given by the holders), declare to be due and payable
immediately the principal (or, if the debt securities of that
series are discount securities, that portion of the principal
amount as may be specified in the terms of that series) of and
premium and accrued and unpaid interest, if any, on all debt
securities of that series. Before a judgment or decree for
payment of the money due has been obtained with respect to debt
securities of any series, the holders of a majority in principal
amount of the outstanding debt securities of that series (or, at
a meeting of holders of such series at which a quorum is
present, the holders of a majority in principal amount of the
debt securities of such series represented at such meeting) the
acceleration shall be deemed to have been waived, rescinded and
annulled if all events of default, other than the non-payment of
accelerated principal, premium, if any, and interest, if any,
with respect to debt securities of that series, have been cured
or waived as provided in the applicable indenture (including
payments or deposits in respect of principal, premium or
interest that had become due other than as a result of such
acceleration) and the Company has deposited with the indenture
trustee or paying agent a sum sufficient to pay all amounts owed
to the indenture trustee under the indenture, all arrears of
interest, if any, on the debt securities, and the principal and
premium, if any, on the debt securities that have become due
other than by such acceleration. We refer you to the prospectus
supplement relating to any series of debt securities that are
discount securities for the particular provisions relating to
acceleration of a portion of the principal amount of such
discount securities upon the occurrence of an event of default.
Subject to the terms of the indenture, if an event of default
under the indenture shall occur and be continuing, the debenture
trustee will be under no obligation to exercise any of its
rights or powers under such indenture at the request or
direction of any of the holders of the applicable series of debt
securities, unless such holders have offered the debenture
trustee reasonable indemnity. The holders of a majority in
principal amount of the outstanding debt securities of any
series will have the right to direct the time, method and place
of conducting any proceeding for any remedy available to the
debenture trustee, or exercising any trust or power conferred on
the debenture trustee, with respect to the debt securities of
that series, provided that:
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the direction so given by the holder is not in conflict with any
law or the applicable indenture; and
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subject to its duties under the Trust Indenture Act, the
debenture trustee need not take any action that might involve it
in personal liability or might be unduly prejudicial to the
holders not involved in the proceeding.
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A holder of the debt securities of any series will only have the
right to institute a proceeding under the indenture or to
appoint a receiver or trustee, or to seek other remedies if:
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the holder previously has given written notice to the debenture
trustee of a continuing event of default with respect to that
series;
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the holders of at least a majority in aggregate principal amount
of the outstanding debt securities of that series have made
written request, and such holders have offered reasonable
indemnity to the debenture trustee to institute the proceeding
as trustee; and
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the debenture trustee does not institute the proceeding, and
does not receive from the holders of a majority in aggregate
principal amount of the outstanding debt securities of that
series (or at a meeting of holders of such series at which a
quorum is present, the holders of a majority in principal amount
of the debt securities of such series represented at such
meeting) other conflicting directions within 60 days after
the notice, request and offer.
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These limitations do not apply to a suit instituted by a holder
of debt securities if we default in the payment of the
principal, premium, if any, or interest on, the debt securities.
We will periodically file statements with the applicable
debenture trustee regarding our compliance with specified
covenants in the applicable indenture.
11
Modification
of Indenture; Waiver
The debenture trustee and we may change the applicable indenture
without the consent of any holders with respect to specific
matters, including:
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to fix any ambiguity, defect or inconsistency in the
indenture; and
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to change anything that does not materially adversely affect the
interests of any holder of debt securities of any series issued
pursuant to such indenture.
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In addition, under the indenture, the rights of holders of a
series of debt securities may be changed by us and the debenture
trustee with the written consent of the holders of at least a
majority in aggregate principal amount of the outstanding debt
securities of each series (or, at a meeting of holders of such
series at which a quorum is present, the holders of a majority
in principal amount of the debt securities of such series
represented at such meeting) that is affected. However, the
debenture trustee and we may make the following changes only
with the consent of each holder of any outstanding debt
securities affected:
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extending the fixed maturity of the series of debt securities;
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reducing the principal amount, reducing the rate of or extending
the time of payment of interest, or any premium payable upon the
redemption of any debt securities;
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reducing the principal amount of discount securities payable
upon acceleration of maturity;
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making the principal of or premium or interest on any debt
security payable in currency other than that stated in the debt
security;
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impairing the right to institute suit for the enforcement of any
payment on or after the fixed maturity date of any series of
debt securities;
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materially adversely affect the economic terms of any right to
convert or exchange any debt securities; and
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reducing the percentage of debt securities, the holders of which
are required to consent to any amendment or waiver; or
modifying, without the written consent of the trustee, the
rights, duties or immunities of the trustee.
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Except for certain specified provisions, the holders of at least
a majority in principal amount of the outstanding debt
securities of any series (or, at a meeting of holders of such
series at which a quorum is present, the holders of a majority
in principal amount of the debt securities of such series
represented at such meeting) may on behalf of the holders of all
debt securities of that series waive our compliance with
provisions of the indenture. The holders of a majority in
principal amount of the outstanding debt securities of any
series may on behalf of the holders of all the debt securities
of such series waive any past default under the indenture with
respect to that series and its consequences, other than a
default in the payment of the principal of, premium or any
interest on any debt security of that series;
provided,
however,
that the holders of a majority in principal amount
of the outstanding debt securities of any series may rescind an
acceleration and its consequences, including any related payment
default that resulted from the acceleration.
Discharge
Each indenture provides that we can elect to be discharged from
our obligations with respect to one or more series of debt
securities, except for obligations to:
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register the transfer or exchange of debt securities of the
series;
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maintain paying agencies;
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hold monies for payment in trust;
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compensate and indemnify the trustee; and
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appoint any successor trustee.
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In order to exercise our rights to be discharged with respect to
a series, we must deposit with the trustee money or government
obligations sufficient to pay all the principal of, the premium,
if any, and interest on, the debt securities of the series on
the dates payments are due.
12
Form,
Exchange, and Transfer
We will issue the debt securities of each series only in fully
registered form without coupons and, unless we otherwise specify
in the applicable prospectus supplement, in denominations of
$1,000 and any integral multiple thereof. The indenture provides
that we may issue debt securities of a series in temporary or
permanent global form and as book-entry securities that will be
deposited with, or on behalf of, depositary named by us and
identified in a prospectus supplement with respect to that
series.
At the option of the holder, subject to the terms of the
indenture and the limitations applicable to global securities
described in the applicable prospectus supplement, the holder of
the debt securities of any series can exchange the debt
securities for other debt securities of the same series, in any
authorized denomination and of like tenor and aggregate
principal amount.
Subject to the terms of the indenture and the limitations
applicable to global securities set forth in the applicable
prospectus supplement, holders of the debt securities may
present the debt securities for exchange or for registration of
transfer, duly endorsed or with the form of transfer endorsed
thereon duly executed if so required by us or the security
registrar, at the office of the security registrar or at the
office of any transfer agent designated by us for this purpose.
Unless otherwise provided in the debt securities that the holder
presents for transfer or exchange or in the indenture, we will
make no service charge for any registration of transfer or
exchange, but we may require payment of any taxes or other
governmental charges.
We will name in the applicable prospectus supplement the
security registrar, and any transfer agent in addition to the
security registrar, that we initially designate for any debt
securities. We may at any time designate additional transfer
agents or rescind the designation of any transfer agent or
approve a change in the office through which any transfer agent
acts, except that we will be required to maintain a transfer
agent in each place of payment for the debt securities of each
series.
If we elect to redeem the debt securities of any series, we will
not be required to:
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issue, register the transfer of, or exchange any debt securities
of that series during a period beginning at the opening of
business 15 days before the day of mailing of a notice of
redemption of any debt securities that may be selected for
redemption and ending at the close of business on the day of the
mailing; or
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register the transfer of or exchange any debt securities so
selected for redemption, in whole or in part, except the
unredeemed portion of any debt securities we are redeeming in
part.
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Information
Concerning the Debenture Trustee
The debenture trustee, other than during the occurrence and
continuance of an event of default under the indenture,
undertakes to perform only those duties as are specifically set
forth in the indenture. Upon an event of default under the
indenture, the debenture trustee must use the same degree of
care as a prudent person would exercise or use in the conduct of
his or her own affairs. Subject to this provision, the debenture
trustee is under no obligation to exercise any of the powers
given it by the indenture at the request of any holder of debt
securities unless it is offered reasonable security and
indemnity against the costs, expenses and liabilities that it
might incur.
Payment
and Paying Agents
Unless we otherwise indicate in the applicable prospectus
supplement, we will make payment of the interest on any debt
securities on any interest payment date to the person in whose
name the debt securities, or one or more predecessor securities,
are registered at the close of business on the regular record
date for the interest.
Unless we otherwise indicate in the applicable prospectus
supplement, we will pay principal of and any premium and
interest on the debt securities of a particular series at the
office of the indenture trustee, or, at the option of the
Company, by check which we mail to the holder. Unless we
otherwise indicate in a prospectus supplement, we will designate
the corporate trust office of the debenture trustee our sole
paying agent for payments with respect to debt securities of
each series. We will name in the applicable prospectus
13
supplement any other paying agents that we initially designate
for the debt securities of a particular series. We will maintain
a paying agent in each place of payment for the debt securities
of a particular series.
All money we pay to a paying agent or the debenture trustee for
the payment of the principal of or any premium or interest on
any debt securities which remains unclaimed at the end of two
years after such principal, premium or interest has become due
and payable will be repaid to us, and the holder of the security
thereafter may look only to us for payment thereof.
Governing
Law
The indenture and the debt securities will be governed and
construed in accordance with the laws of the State of New York.
DESCRIPTION
OF WARRANTS
We may issue warrants for the purchase of common stock,
preferred stock
and/or
debt
securities in one or more series. We may issue warrants
independently or together with common stock, preferred stock
and/or
debt
securities, and the warrants may be attached to or separate from
these securities. While the terms summarized below will apply
generally to any warrants that we may offer, we will describe
the particular terms of any series of warrants in more detail in
the applicable prospectus supplement. The terms of any warrants
offered under a prospectus supplement may differ from the terms
described below.
We will file as exhibits to the registration statement of which
this prospectus is a part, or will incorporate by reference from
reports that we file with the SEC, the form of warrant
agreement, including a form of warrant certificate, that
describes the terms of the particular series of warrants we are
offering before the issuance of the related series of warrants.
The following summaries of material provisions of the warrants
and the warrant agreements are subject to, and qualified in
their entirety by reference to, all the provisions of the
warrant agreement and warrant certificate applicable to the
particular series of warrants that we may offer under this
prospectus. We urge you to read the applicable prospectus
supplements related to the particular series of warrants that we
may offer under this prospectus, as well as the complete warrant
agreements and warrant certificates that contain the terms of
the warrants.
General
We will describe in the applicable prospectus supplement the
terms of the series of warrants being offered, including:
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the offering price and aggregate number of warrants offered;
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the currency for which the warrants may be purchased;
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if applicable, the designation and terms of the securities with
which the warrants are issued and the number of warrants issued
with each such security or each principal amount of such
security;
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if applicable, the date on and after which the warrants and the
related securities will be separately transferable;
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in the case of warrants to purchase debt securities, the
principal amount of debt securities purchasable upon exercise of
one warrant and the price at, and currency in which, this
principal amount of debt securities may be purchased upon such
exercise;
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in the case of warrants to purchase common stock or preferred
stock, the number of shares of common stock or preferred stock,
as the case may be, purchasable upon the exercise of one warrant
and the price at which these shares may be purchased upon such
exercise;
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the effect of any merger, consolidation, sale or other
disposition of our business on the warrant agreements and the
warrants;
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the terms of any rights to redeem or call the warrants;
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any provisions for changes to or adjustments in the exercise
price or number of securities issuable upon exercise of the
warrants;
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the dates on which the right to exercise the warrants will
commence and expire;
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the manner in which the warrant agreements and warrants may be
modified;
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a discussion of any material or special United States federal
income tax consequences of holding or exercising the warrants;
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the terms of the securities issuable upon exercise of the
warrants; and
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any other specific terms, preferences, rights or limitations of
or restrictions on the warrants.
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Before exercising their warrants, holders of warrants will not
have any of the rights of holders of the securities purchasable
upon such exercise, including:
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in the case of warrants to purchase debt securities, the right
to receive payments of principal of, or premium, if any, or
interest on, the debt securities purchasable upon exercise or to
enforce covenants in the applicable indenture; or
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in the case of warrants to purchase common stock or preferred
stock, the right to receive dividends, if any, or payments upon
our liquidation, dissolution or winding up or to exercise voting
rights, if any.
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Exercise
of Warrants
Each warrant will entitle the holder to purchase the securities
that we specify in the applicable prospectus supplement at the
exercise price that we describe in the applicable prospectus
supplement. Holders of the warrants may exercise the warrants at
any time up to the specified time on the expiration date that we
set forth in the applicable prospectus supplement. After the
close of business on the expiration date, unexercised warrants
will become void.
Holders of the warrants may exercise the warrants by delivering
the warrant certificate representing the warrants to be
exercised together with specified information, and paying the
required amount to the warrant agent in immediately available
funds, as provided in the applicable prospectus supplement. We
will set forth on the reverse side of the warrant certificate
and in the applicable prospectus supplement the information that
the holder of the warrant will be required to deliver to the
warrant agent.
Upon receipt of the required payment and the warrant certificate
properly completed and duly executed at the corporate trust
office of the warrant agent or any other office indicated in the
applicable prospectus supplement, we will issue and deliver the
securities purchasable upon such exercise. If fewer than all of
the warrants represented by the warrant certificate are
exercised, then we will issue a new warrant certificate for the
remaining amount of warrants. If we so indicate in the
applicable prospectus supplement, holders of the warrants may
surrender securities as all or part of the exercise price for
warrants.
Governing
Law
Unless we provide otherwise in the applicable prospectus
supplement, the warrants and warrant agreements will be governed
by and construed in accordance with the laws of the State of New
York.
Enforceability
of Rights by Holders of Warrants
The warrant agent will act solely as our agent under the
applicable warrant agreement and will not assume any obligation
or relationship of agency or trust with any holder of any
warrant. A single bank or trust company may act as warrant agent
for more than one issue of warrants. A warrant agent will have
no duty or responsibility in case of any default by us under the
applicable warrant agreement or warrant, including any duty or
responsibility to initiate any proceedings at law or otherwise,
or to make any demand upon us. Any holder of a warrant may,
without the consent of the related warrant agent or the holder
of any other warrant, enforce by appropriate legal action its
right to exercise, and receive the securities purchasable upon
exercise of, its warrants.
15
Outstanding
Warrants
As of March 25, 2010, we had warrants outstanding to
purchase 14,047,015 shares of our Common Stock.
DESCRIPTION
OF RIGHTS
We may issue rights to our stockholders to purchase shares of
our common stock, preferred stock or the other securities
described in this prospectus. We may offer rights separately or
together with one or more additional rights, debt securities,
preferred stock, common stock, warrants, or any combination of
those securities, as described in the applicable prospectus
supplement. Each series of rights will be issued under a
separate rights agreement to be entered into between us and a
bank or trust company, as rights agent. The rights agent will
act solely as our agent in connection with the certificates
relating to the rights of the series of certificates and will
not assume any obligation or relationship of agency or trust for
or with any holders of rights certificates or beneficial owners
of rights. The following description sets forth certain general
terms and provisions of the rights that we may offer. The terms
of any rights offered under a prospectus supplement may differ
from the terms described below.
We will file as exhibits to the registration statement of which
this prospectus is a part, or will incorporate by reference from
reports that we file with the SEC, the form of rights agreement,
including a form of rights certificate, that describes the terms
of the particular rights we are offering before the issuance of
the related rights. The following summaries of material
provisions of the rights and the rights agreements are subject
to, and qualified in their entirety by reference to, all the
provisions of the rights agreement and rights certificate
applicable to the particular rights that we may offer under this
prospectus. We urge you to read the applicable prospectus
supplements related to the rights that we may offer under this
prospectus, as well as the complete rights agreements and rights
certificates that contain the terms of the rights.
We will describe in the applicable prospectus supplement the
terms of the rights being offered, including:
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the date of determining the stockholders entitled to the rights
distribution;
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the aggregate number of shares of common stock, preferred stock
or other securities purchasable upon exercise of the rights;
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the exercise price;
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the aggregate number of rights issued;
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the date, if any, on and after which the rights will be
separately transferable;
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the date on which the right to exercise the rights will
commence, and the date on which the right to exercise the rights
will expire;
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the method by which holders of rights will be entitled to
exercise;
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the conditions to the completion of the offering, if any;
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the withdrawal, termination and cancellation rights, if any;
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whether the rights are transferrable;
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whether there are any backstop or standby purchaser or
purchasers and the terms of their commitment, if any;
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whether stockholders are entitled to oversubscription rights, if
any;
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any applicable federal income tax considerations; and
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any other terms of the rights, including terms, procedures and
limitations relating to the distribution, exchange and exercise
of the rights, as applicable.
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Exercise
of Rights
Each right will entitle the holder of rights to purchase for
cash the principal amount of shares of common stock, preferred
stock or other securities at the exercise price provided in the
applicable prospectus supplement. Rights may be exercised at any
time up to the close of business on the expiration date for the
rights provided in the applicable prospectus supplement.
Holders may exercise rights as described in the applicable
prospectus supplement. Upon receipt of payment and the rights
certificate properly completed and duly executed at the
corporate trust office of the rights agent
16
or any other office indicated in the prospectus supplement, we
will, as soon as practicable, forward the shares of common
stock, preferred stock or other securities, as applicable,
purchasable upon exercise of the rights. If less than all of the
rights issued in any rights offering are exercised, we may offer
any unsubscribed securities directly to persons other than
stockholders, to or through agents, underwriters or dealers or
through a combination of such methods, including pursuant to
standby arrangements, as described in the applicable prospectus
supplement.
Governing
Law
Unless we provide otherwise in the applicable prospectus
supplement, the rights and rights agreements will be governed by
and construed in accordance with the laws of the State of New
York.
DESCRIPTION
OF UNITS
We may issue, in one more series, units consisting of common
stock, preferred stock, debt securities
and/or
warrants for the purchase of common stock, preferred stock
and/or
debt
securities in any combination. While the terms we have
summarized below will apply generally to any units that we may
offer under this prospectus, we will describe the particular
terms of any series of units in more detail in the applicable
prospectus supplement. The terms of any units offered under a
prospectus supplement may differ from the terms described below.
We will file as exhibits to the registration statement of which
this prospectus is a part, or will incorporate by reference from
reports that we file with the SEC, the form of unit agreement
that describes the terms of the series of units we are offering,
and any supplemental agreements, before the issuance of the
related series of units. The following summaries of material
terms and provisions of the units are subject to, and qualified
in their entirety by reference to, all the provisions of the
unit agreement and any supplemental agreements applicable to a
particular series of units. We urge you to read the applicable
prospectus supplements related to the particular series of units
that we may offer under this prospectus, as well as any related
free writing prospectuses and the complete unit agreement and
any supplemental agreements that contain the terms of the units.
General
Each unit will be issued so that the holder of the unit is also
the holder of each security included in the unit. Thus, the
holder of a unit will have the rights and obligations of a
holder of each included security. The unit agreement under which
a unit is issued may provide that the securities included in the
unit may not be held or transferred separately, at any time or
at any time before a specified date.
We will describe in the applicable prospectus supplement the
terms of the series of units being offered, including:
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the designation and terms of the units and of the securities
comprising the units, including whether and under what
circumstances those securities may be held or transferred
separately;
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any provisions of the governing unit agreement that differ from
those described below; and
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any provisions for the issuance, payment, settlement, transfer
or exchange of the units or of the securities comprising the
units.
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The provisions described in this section, as well as those
described under DESCRIPTION OF CAPITAL STOCK,
DESCRIPTION OF DEBT SECURITIES and DESCRIPTION
OF WARRANTS will apply to each unit and to any common
stock, preferred stock, debt security or warrant included in
each unit, respectively.
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Enforceability
of Rights by Holders of Units
Each unit agent will act solely as our agent under the
applicable unit agreement and will not assume any obligation or
relationship of agency or trust with any holder of any unit. A
single bank or trust company may act as unit agent for more than
one series of units. A unit agent will have no duty or
responsibility in case of any default by us under the applicable
unit agreement or unit, including any duty or responsibility to
initiate any proceedings at law or otherwise, or to make any
demand upon us. Any holder of a unit may, without the consent of
the related unit agent or the holder of any other unit, enforce
by appropriate legal action its rights as holder under any
security included in the unit.
PLAN OF
DISTRIBUTION
We may sell the securities to one or more underwriters for
public offering and sale by them and may also sell the
securities to investors directly or through agents, or through a
combination of such methods. Any such underwriter or agent
involved in the offer and sale of securities will be named in
the applicable prospectus supplement. We have reserved the right
to sell securities directly to investors on our own behalf in
those jurisdictions where and in such manner as we are
authorized to do so.
The distribution of the securities may be effected from time to
time in one or more transactions at a fixed price or prices,
which may be changed, or at market prices prevailing at the time
of sale, at prices related to prevailing market prices, or at
negotiated prices. Sales of Common Stock may be effected from
time to time in one or more transactions on the NASDAQ or in
negotiated transactions or a combination of those methods. We
may also, from time to time, authorize dealers, acting as our
agents, to offer and sell securities upon the terms and
conditions as are set forth in the applicable prospectus
supplement. In connection with the sale of securities,
underwriters or agents may receive compensation from us in the
form of fees, underwriting discounts or commissions and may also
receive commissions from purchasers of the securities for whom
they may act as agent. Underwriters may sell securities to or
through dealers, and those dealers may receive compensation in
the form of discounts, concessions or commissions from the
underwriters
and/or
commissions from the purchasers for whom they may act as agent.
Unless otherwise indicated in a prospectus supplement, an agent
will be acting on a reasonable efforts basis and a dealer will
purchase securities as a principal, and may then resell such
securities at varying prices to be determined by the dealer.
Any fees or underwriting compensation paid by us to underwriters
or agents in connection with the offering of securities, and any
discounts, concessions or commissions allowed by underwriters to
participating dealers, will be set forth in the applicable
prospectus supplement. Dealers and agents participating in the
distribution of securities may be deemed to be underwriters, and
any discounts and commissions received by them and any profit
realized by them on resale of the securities may be deemed to be
underwriting discounts and commissions. Underwriters, dealers
and agents may be entitled, under agreements entered into with
us, to indemnification against and contribution toward certain
civil liabilities, including liabilities under the Securities
Act, and to reimbursement by us for expenses. The terms of any
indemnification provisions will be set forth in a prospectus
supplement.
To facilitate an offering of a series of securities, persons
participating in the offering may engage in transactions that
stabilize, maintain, or otherwise affect the market price of the
securities. This may include over-allotments or short sales of
the securities, which involves the sale by persons participating
in the offering of more securities than have been sold to them
by us. In those circumstances, such persons would cover such
over-allotments or short positions by purchasing in the open
market or by exercising the over-allotment option granted to
those persons. In addition, those persons may stabilize or
maintain the price of the securities by bidding for or
purchasing securities in the open market or by imposing penalty
bids, whereby selling concessions allowed to underwriters or
dealers participating in any such offering may be reclaimed if
securities sold by them are repurchased in connection with
stabilization transactions. The effect of these transactions may
be to stabilize or maintain the market price of the securities
at a level above that which might otherwise prevail in the open
market. Such transactions, if commenced, may be discontinued at
any time. We make no representation or prediction as to the
direction or magnitude of any effect that the transactions
described
18
above, if implemented, may have on the price of our securities.
The underwriters, dealers and agents may engage in transactions
with us, or perform services for us, in the ordinary course of
business.
Each series of securities will be a new issue of securities and
may have no established trading market (other than our common
stock). Any common stock sold pursuant to a prospectus
supplement will be eligible for trading on the NASDAQ Capital
Market, subject, if required, to official notice of issuance, or
such other trading market as specified in a prospectus
supplement. Any securities sold pursuant to a prospectus
supplement, other than our common stock, may or may not be
listed on a national securities exchange or approved for trading
on any other trading market.
19
WHERE YOU
CAN FIND MORE INFORMATION
We file annual, quarterly and current reports, proxy statements
and other information with the Securities and Exchange
Commission, or SEC. You may read and copy any document we file
with the SEC at the public reference room maintained by the SEC
at 100 F Street, N.E., Washington, D.C. 20549.
Copies may also be obtained from the Public Reference Section of
the SEC at 100 F Street, N.E., Washington, D.C.
20549 at prescribed rates. You may obtain information on the
operation of the public reference room by calling the SEC at
1-800-SEC-0330.
In addition, the SEC maintains an Internet site
(http://www.sec.gov)
that contains reports, proxy and information statements and
other information regarding registrants who file electronically
with the SEC.
This prospectus is part of a registration statement that we
filed with the SEC. The registration statement contains more
information than this prospectus regarding us and our
securities, including certain exhibits and schedules. You can
obtain a copy of the registration statement from the SEC at the
address listed above or from the SECs Internet site
(http://www.sec.gov).
INCORPORATION
BY REFERENCE
The SEC allows us to incorporate by reference
information that we file with it, which means that we can
disclose important information to you by referring you to those
documents. The information incorporated by reference is an
important part of this prospectus, and information that we file
later with the SEC will automatically update and supersede this
information. We incorporate by reference the documents listed
below and any future filings we will make with the SEC under
Section 13(a), 13(c), 14 or 15(d) of the Securities
Exchange Act of 1934, or the Exchange Act, after the date of the
prospectus but before the termination of any offering made under
this prospectus and accompanying prospectus supplement:
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our annual report on
Form 10-K
for the fiscal year ended December 31, 2009, filed with the
SEC on March 26, 2010;
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our definitive proxy statements filed with the SEC on
April 27, 2009 and April 30, 2010;
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our current reports on
Form 8-K,
filed with the SEC on January 11, 2010, February 5,
2010, February 22, 2010 and March 23, 2010; and
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the description of our Common Stock and Preferred Stock
contained in the registration statement on
Form 8-A,
filed on May 21, 2004, and all amendments and reports
updating such description.
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Upon oral or written request and at no cost to the requester, we
will provide to any person, including a beneficial owner, to
whom a prospectus is delivered, a copy of any or all the
information that has been incorporated by reference in this
prospectus but not delivered with this prospectus. All requests
should be made to: Inhibitex, Inc., 9005 Westside Parkway,
Alpharetta, GA 30009, Attn: Corporate Secretary. You should rely
only on the information incorporated by reference or provided in
this prospectus. We have not authorized anyone to provide you
with different information. You should not assume that the
information in this prospectus or the documents incorporated by
reference is accurate as of any date other than the date on the
front of this prospectus or those documents.
LEGAL
MATTERS
The validity of the securities offered hereby will be passed
upon for us by Dechert LLP, New York, New York.
EXPERTS
The consolidated financial statements of Inhibitex, Inc.
incorporated by reference in the Inhibitex Inc. Annual Report
(Form 10-K)
for the year ended December 31, 2009, have been audited by
Ernst & Young LLP, independent registered public
accounting firm, as set forth in their report thereon,
incorporated by reference therein, and incorporated herein by
reference. Such consolidated financial statements are
incorporated herein by reference in reliance upon such report
given on the authority of such firm as experts in accounting and
auditing.
20
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