ABOUT
THIS PROSPECTUS
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1
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OUR
BUSINESS
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2
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RISK
FACTORS
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5
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FORWARD-LOOKING
STATEMENTS AND CAUTIONARY STATEMENTS
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18
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USE
OF PROCEEDS
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19
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SELLING
STOCKHOLDERS
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20
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PLAN
OF DISTRIBUTION
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24
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LEGAL
MATTERS
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25
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EXPERTS
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25
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WHERE
YOU CAN FIND MORE INFORMATION
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25
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INCORPORATION
OF CERTAIN DOCUMENTS BY REFERENCE
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26
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·
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ALT-2074
is a glutathione peroxidase mimetic in clinical development for
reducing
the morbidity and mortality of patients with diabetes following
a
myocardial infarction. ALT-2074 has demonstrated potential efficacy
in
animal models of heart attack and in a 20-patient clinical trial
in
ulcerative colitis. Our goal is to develop ALT-2074 in acute coronary
syndrome as a targeted drug for high risk diabetic patients. The
compound
has demonstrated the ability to reduce infarct size by approximately
85
percent in a mouse model of heart attack called ischemia reperfusion
injury. It is currently being evaluated in a clinical trial for
evidence
of myocardial protection following angioplasty in high-risk diabetic
patients. This Phase 2 clinical study was opened for enrollment
in Israel,
in May 2006. We expect to report results of this trial in the first
half
of 2008. In June 2007, we initiated a Phase 2 study using ALT-2074
in
diabetic patients, testing positive for a marker of increased
cardiovascular risk (haptoglobin genotype testing). Patients are
being
treated with ascending doses of ALT-2074 or placebo for 28 days
as we
track inflammatory biomarkers and functional improvement in their
reverse
cholesterol transport. Results from this study are anticipated
in the
first quarter of 2008.
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·
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Alagebrium
chloride or alagebrium (formerly ALT-711), is an advanced glycation
end-product crosslink breaker being developed for diastolic heart
failure
(“DHF”) and diabetic nephropathy. Alagebrium has demonstrated potential
efficacy in two clinical trials in heart failure, as well as in
animal
models of heart failure, nephropathy, hypertension and erectile
dysfunction (“ED”). These diseases represent rapidly growing markets of
unmet medical needs, particularly common among diabetic patients.
The
compound has been tested in approximately 1,000 patients, which
represents
a sizeable human safety database, in a number of Phase 2 clinical
studies
in another cardiovascular indication.
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·
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incur
debt in excess of $2,000,000,
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·
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authorize
securities at a price per share less than the price per share at
which the
Series B Preferred Stock has been sold under the Purchase Agreement,
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·
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increase
our authorized capital,
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·
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create
any new classes or series of stock with rights senior to the common
stock,
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·
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issue
any shares of our Series A Preferred Stock, other than in accordance
with
our shareholder rights plan,
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·
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amend
any provision of our Certificate of Incorporation or Bylaws that
changes
the rights of the Series B Preferred Stock,
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·
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pay
or declare any dividend on any of our capital stock,
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·
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purchase
or redeem any securities,
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·
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issue
any securities to employees other than pursuant to our 2005 Stock
Plan, or
increase the number of shares of common stock reserved for issuance
under
the 2005 Stock Plan,
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·
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liquidate,
dissolve or wind-up,
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·
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merge
with another entity,
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·
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sell
or dispose of any of our assets, including the sale or license
of our
intellectual property,
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·
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change
the number of directors,
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·
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amend
any portion of our Certificate of Incorporation or Bylaws,
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·
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materially
change the nature of our business,
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·
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intentionally
take any action that may result in our stock no longer being approved
for
quotation on the AMEX or NASDAQ, or that would cause our common
stock to
no longer be registered pursuant to Section 12 of the Securities
Exchange
Act of 1934, or
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·
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amend
any material agreement that has been filed with the Securities
and
Exchange Commission.
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·
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delay,
reduce the scope of or eliminate one or more of our development
programs;
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·
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obtain
funds through arrangements with collaboration partners or others
that may
require us to relinquish rights to some or all of our technologies,
product candidates or products that we would otherwise seek to
develop or
commercialize ourselves;
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·
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license
rights to technologies, product candidates or products on terms
that are
less favorable to us than might otherwise be
available;
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·
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seek
a buyer for all or a portion of our business;
or
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·
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wind
down our operations and liquidate our assets on terms that are
unfavorable
to us.
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·
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slower
than expected patient enrollment due to the nature of the protocol,
the
proximity of subjects to clinical sites, the eligibility criteria
for the
study, competition with clinical trials for other drug candidates
or other
factors;
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·
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adverse
results in preclinical safety or toxicity
studies;
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·
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lower
than expected recruitment or retention rates of subjects in a clinical
trial;
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·
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inadequately
trained or insufficient personnel at the study site to assist in
overseeing and monitoring clinical
trials;
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·
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delays
in approvals from a study site’s review board, or other required
approvals;
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·
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longer
treatment time required to demonstrate effectiveness or determine
the
appropriate product dose;
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·
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lack
of sufficient supplies of the product
candidate;
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·
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adverse
medical events or side effects in treated
subjects;
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·
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lack
of effectiveness of the product candidate being tested;
and
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·
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regulatory
changes.
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·
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ongoing
preclinical or clinical study results may indicate that the product
candidate is not safe or effective;
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·
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the
FDA may interpret our preclinical or clinical study results to
indicate
that the product candidate is not safe or effective, even if we
interpret
the results differently; or
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·
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the
FDA may deem the processes and facilities that our collaborative
partners,
our third-party manufacturers or we propose to use in connection
with the
manufacture of the product candidate to be
unacceptable.
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·
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collaborators
may fail to adequately perform the scientific and preclinical studies
called for under our agreements with
them;
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·
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collaborators
have significant discretion in determining the efforts and resources
that
they will apply to these
collaborations;
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·
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collaborators
may not pursue further development and commercialization of our
product
candidates or may elect not to continue or renew research and development
programs based on preclinical or clinical study results, changes
in their
strategic focus or available funding or external factors, such
as an
acquisition that diverts resources or creates competing
priorities;
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·
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collaborators
may delay clinical trials, provide insufficient funding for a clinical
program, stop a clinical study or abandon a product candidate,
repeat or
conduct new clinical trials or require a new formulation of a product
candidate for clinical testing;
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·
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collaborators
could independently develop, or develop with third parties, products
that
compete directly or indirectly with our products or product candidates
if
the collaborators believe that competitive products are more likely
to be
successfully developed or can be commercialized under terms that
are more
economically attractive; collaborators with marketing and distribution
rights to one or more products may not commit enough resources
to their
marketing and distribution;
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·
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collaborators
may not properly maintain or defend our intellectual property rights
or
may use our proprietary information in such a way as to invite
litigation
that could jeopardize or invalidate our proprietary information
or expose
us to potential litigation;
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·
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disputes
may arise between us and the collaborators that result in the delay
or
termination of the research, development or commercialization of
our
product candidates or that result in costly litigation or arbitration
that
diverts management attention and resources;
and
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·
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collaborations
may be terminated and, if terminated, may result in a need for
additional
capital to pursue further development of the applicable product
candidates.
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·
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restrictions
on the products, manufacturers or manufacturing
processes;
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·
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warning
letters;
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·
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civil
or criminal penalties;
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·
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fines;
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·
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injunctions;
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·
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product
seizures or detentions;
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·
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import
bans;
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·
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voluntary
or mandatory product recalls and publicity
requirements;
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·
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suspension
or withdrawal of regulatory
approvals;
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·
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total
or partial suspension of production;
and
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·
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refusal
to approve pending applications for marketing approval of new drugs
or
supplements to approved
applications.
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·
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could
encounter difficulties in achieving volume production, quality
control and
quality assurance and suffer shortages of qualified personnel,
which could
result in their inability to manufacture sufficient quantities
of drugs to
meet our clinical schedules or to commercialize our product
candidates;
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·
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could
terminate or choose not to renew the manufacturing agreement, based
on
their own business priorities, at a time that is costly or inconvenient
for us;
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·
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could
fail to establish and follow FDA-mandated cGMP, as required for
FDA
approval of our product candidates, or fail to document their adherence
to
cGMP, either of which could lead to significant delays in the availability
of material for clinical study and delay or prevent filing or approval
of
marketing applications for our product candidates;
and
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·
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could
breach, or fail to perform as agreed, under the manufacturing
agreement.
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·
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attract
and retain skilled scientific and research
personnel;
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develop
technologically superior products;
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·
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develop
competitively priced products;
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obtain
patent or other required regulatory approvals for our
products;
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·
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be
early entrants to the market; and
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·
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manufacture,
market and sell our products, independently or through
collaborations.
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·
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incur
debt in excess of $2,000,000;
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·
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authorize
securities at a price per share less than the price per share that
the
Series B Preferred Stock has been sold under the Series B Purchase
Agreement;
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·
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increase
our authorized capital;
|
·
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create
any new classes or series of stock with rights senior to the common
stock;
|
·
|
issue
any shares of Series A Preferred Stock, other than in accordance
with our
shareholder rights plan;
|
·
|
amend
any provision of our Certificate of Incorporation or Bylaws that
changes
the rights of the Series B Preferred Stock;
|
·
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pay
or declare any dividend on any of our capital stock;
|
·
|
purchase
or redeem any securities;
|
·
|
issue
any securities to employees other than pursuant to our 2005 Stock
Plan, or
increase the number of shares of common stock reserved for issuance
under
the 2005 Stock Plan;
|
·
|
liquidate,
dissolve or wind-up;
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·
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merge
with another entity;
|
·
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sell
or dispose of any of our assets, including the sale or license of
our
intellectual property;
|
·
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change
the number of directors;
|
·
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amend
any portion of our Certificate of Incorporation or Bylaws;
|
·
|
materially
change the nature of our business;
|
·
|
intentionally
take any action that may result in our stock no longer being approved
for
quotation on the AMEX or NASDAQ, or that would cause our common
stock to
no longer be registered pursuant to Section 12 of the Securities
Exchange
Act of 1934; or
|
·
|
amend
any material agreement that has been filed with the Securities
and
Exchange Commission.
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·
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quarterly
fluctuations in results of
operations;
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·
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material
weaknesses in our internal control over financial
reporting;
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·
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the
announcement of new products or services by us or
competitors;
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·
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sales
of common stock by existing stockholders or the perception that
these
sales may occur;
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·
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adverse
judgments or settlements obligating the combined company to pay
damages;
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·
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negative
publicity;
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·
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loss
of key personnel;
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·
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developments
concerning proprietary rights, including patents and litigation
matters;
and
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·
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clinical
trial or regulatory developments in both the United States and
foreign
countries.
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SHARES
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SHARES
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|||||||||||||
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BENEFICALLY
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BENEFICALLY
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|||||||||||||
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OWNED
BEFORE
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SHARES
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OWNED
AFTER
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|||||||||||||
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OFFERING(1)
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BEING
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OFFERING(2)
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SELLING
STOCKHOLDER
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NUMBER
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PERCENT
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OFFERED
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NUMBER
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PERCENT
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|||||||||||
Baker/Tisch
Investments, L.P. (3)
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70,971
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2.67
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%
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3,397
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67,574
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2.55
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%
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Baker
Biotech Fund I, L.P.(4)
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2,740,840
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51.45
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%
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131,208
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2,609,632
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50.22
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%
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|||||||||
Baker
Brothers Life Sciences, L.P. (5)
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7,438,590
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74.20
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%
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356,095
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7,082,495
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73.25
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%
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|||||||||
14159,
L.P. (6)
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240,276
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8.5
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%
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11,502
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228,774
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8.13
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%
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|||||||||
Baker
Brothers Investments II, L.P.(7)
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9,323
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*
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%
|
446
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8,877
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*
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%
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|||||||||
Atticus
Global Advisors, Ltd. L.P. (8)
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1,750,000
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40.36
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%
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83,775
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1,666,225
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39.18
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%
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|||||||||
Green
Way Managed Acct. Series, Ltd.(9)
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250,000
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8.81
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%
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11,968
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238,032
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8.43
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%
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|||||||||
Rodman
& Renshaw, LLC (10)
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624,106
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*
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%
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29,877
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594,229
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*
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%
|
(1)
|
Percentages
prior to the offering are based on 2,586,377 shares
of common stock that were issued and outstanding as of August 22,
2007. We
deem shares of common stock that may be acquired by an individual
or group
within 60 days of August 22, 2007 pursuant to the exercise of options
or warrants or the conversion of convertible securities to be outstanding
for the purpose of computing the percentage ownership of such individual
or group, but such shares are not deemed to be outstanding for
the purpose
of computing the percentage ownership of any other individual or
entity
shown in the table.
|
(2)
|
We
do not know when or in what amounts the selling stockholders may
offer for
sale the shares of common stock pursuant to this offering. The
selling
stockholders may choose not to sell any of the shares offered by
this
prospectus. Because the selling stockholders may offer all or some
of the
shares of common stock pursuant to this offering, and because there
are
currently no agreements, arrangements or undertakings with respect
to the
sale of any of the shares of common stock, we cannot estimate the
number
of shares of common stock that the selling stockholders will hold
after
completion of the offering. For purposes of this table, we have
assumed
that the selling stockholders will have sold all of the shares
covered by
this prospectus upon the completion of the
offering.
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(3)
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The
number of shares beneficially owned before the offering includes
56,777
shares of common stock issuable upon conversion of Series B Preferred
Stock and 14,194 shares of common stock issuable upon conversion
of Series
B Preferred Stock issuable upon exercise of the warrants that are
exercisable beginning as of the date of issuance of the Warrants
for a
period of five years at an exercise price of $2.50 per share. The
number
of shares being offered consists of 3,397 shares of common stock
issuable
upon conversion of Series B Preferred Stock. Felix Baker and Julian
Baker,
as managing members, have the power to vote or dispose of the securities
owned by Baker Biotech Fund I, L.P.
|
(4)
|
The
number of shares beneficially owned before the offering includes
2,192,672
shares of common stock issuable upon conversion of Series B Preferred
Stock and 548,168 shares of common stock issuable upon conversion
of
Series B Preferred Stock issuable upon exercise of the warrants
that are
exercisable beginning as of the date of issuance of the Warrants
for a
period of five years at an exercise price of $2.50 per share. The
number
of shares being offered consists of 131,208 shares of common stock
issuable upon conversion of Series B Preferred Stock. Felix Baker
and
Julian Baker, as managing members, have the power to vote or dispose
of
the securities owned by Baker/Tisch Investments,
L.P.
|
(5)
|
The
number of shares beneficially owned before the offering includes
5,950,872
shares of common stock issuable upon conversion of Series B Preferred
Stock and 1,487,718 shares of common stock issuable upon conversion
of
Series B Preferred Stock issuable upon exercise of the warrants
that are
exercisable beginning as of the date of issuance of the Warrants
for a
period of five years at an exercise price of $2.50 per share. The
number
of shares being offered consists of 356,095 shares of common stock
issuable upon conversion of Series B Preferred Stock. Felix Baker
and
Julian Baker, as managing members, have the power to vote or dispose
of
the securities owned by Baker Brothers Life Sciences,
L.P.
|
(6)
|
The
number of shares beneficially owned before the offering includes
192,221
shares of common stock issuable upon conversion of Series B Preferred
Stock and 48,055 shares of common stock issuable upon conversion
of Series
B Preferred Stock issuable upon exercise of the warrants that are
exercisable beginning as of the date of issuance of the Warrants
for a
period of five years at an exercise price of $2.50 per share. The
number
of shares being offered consists of 11,502 shares of common stock
issuable
upon conversion of Series B Preferred Stock. Felix Baker and Julian
Baker,
as managing members, have the power to vote or dispose of the securities
owned by 14159, L.P.
|
(7)
|
The
number of shares beneficially owned before the offering includes
7,458
shares of common stock issuable upon conversion of Series B Preferred
Stock and 1,865 shares of common stock issuable upon conversion
of Series
B Preferred Stock issuable upon exercise of the warrants that are
exercisable beginning as of the date of issuance of the Warrants
for a
period of five years at an exercise price of $2.50 per share. The
number
of shares being offered consists of 446 shares of common stock
issuable
upon conversion of Series B Preferred Stock. Felix Baker and Julian
Baker,
as managing members, have the power to vote or dispose of the securities
owned by Baker Brothers Investments II,
L.P.
|
(8)
|
The
number of shares beneficially owned before the offering includes
1,400,000
shares of common stock issuable upon conversion of Series B Preferred
Stock and 350,000 shares of common stock issuable upon conversion
of
Series B Preferred Stock issuable upon exercise of the warrants
that are
exercisable beginning as of the date of issuance of the Warrants
for a
period of five years at an exercise price of $2.50 per share. The
number
of shares being offered consists of 83,775 shares of common stock
issuable
upon conversion of Series B Preferred Stock. Timothy R. Barakett
may be
deemed to have control over the voting or disposition of the securities
owned by Atticus Global Advisors, Ltd.
L.P.
|
(9)
|
The
number of shares beneficially owned before the offering includes
200,000
shares of common stock issuable upon conversion of Series B Preferred
Stock and 50,000 shares of common stock issuable upon conversion
of Series
B Preferred Stock issuable upon exercise of the warrants that are
exercisable beginning as of the date of issuance of the Warrants
for a
period of five years at an exercise price of $2.50 per share. The
number
of shares being offered consists of 11,968 shares of common stock
issuable
upon conversion of Series B Preferred Stock. Timothy R. Barakett
may be
deemed to have control over the voting or disposition of the securities
owned by Green Way Managed Account Series, Ltd.
|
(10) |
The
number of shares beneficially owned before the offering includes
624,106
shares of common stock issuable upon exercise of warrants.
The number of
shares being offered consists of 29,877 shares of common stock
issuable
upon exercise of warrants to purchase our common stock that are
exercisable beginning as of the date of issuance of the warrants
for a
period of five years at an exercise price of $2.50 per share.
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·
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ordinary
brokerage transactions and transactions in which the broker-dealer
solicits purchasers;
|
·
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block
trades in which the broker-dealer will attempt to sell the shares
as agent
but may position and resell a portion of the block as principal
to
facilitate the transaction;
|
·
|
purchases
by a broker-dealer as principal and resale by the broker-dealer
for its
account;
|
·
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an
exchange distribution in accordance with the rules of the applicable
exchange;
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·
|
privately
negotiated transactions;
|
·
|
settlement
of short sales entered into after the effective date of the registration
statement of which this prospectus is a
part;
|
·
|
broker-dealers
may agree with the Selling Stockholders to sell a specified number
of such
shares at a stipulated price per
share;
|
·
|
through
the writing or settlement of options or other hedging transactions,
whether through an options exchange or otherwise;
|
·
|
a
combination of any such methods of sale;
or
|
·
|
any
other method permitted pursuant to applicable
law.
|
·
|
inspect
a copy of the Registration Statement, including the exhibits
and
schedules, without charge at the Public Reference
Room,
|
·
|
obtain
a copy from the SEC upon payment of the fees prescribed by the
SEC,
or
|
·
|
obtain
a copy from the SEC’s web
site.
|
·
|
Our
Annual Report on Form 10-K for the year ended December 31, 2006,
filed on
March 30, 2007 (File No.
001-16043);
|
·
|
Our
Annual Report on Form 10-K/A for the year ended December 31,
2006, filed
on April 30, 2007 (File No. 001-16043);
|
·
|
Our
Annual Report on Form 10-K/A for the year ended December 31,
2006, filed
on October 16, 2007 (File No.
001-16043);
|
·
|
Our
Quarterly Report on Form 10-Q for the quarter ended March 31,
2007, filed
on May 14, 2007 (File No.
001-16043);
|
·
|
Our
Quarterly Report on Form 10-Q for the quarter ended June 30,
2007, filed
on August 14, 2007 (File No. 001-16043);
|
·
|
Our
Quarterly Report on Form 10-Q for the quarter ended September 30,
2007, filed on November 14, 2007 (File No.
001-16043);
|
·
|
Our
Current Report on Form 8-K, filed on January 16, 2007 (File No.
001-16043);
|
·
|
Our
Current Report on Form 8-K, filed on January 22, 2007 (File No.
001-16043);
|
·
|
Our
Current Report on Form 8-K, filed on January 30, 2007 (File No.
001-16043);
|
·
|
Our
Current Report on Form 8-K, filed on February 2, 2007 (File No.
001-16043);
|
·
|
Our
Current Report on Form 8-K, filed on February 8, 2007 (File No.
001-16043);
|
·
|
Our
Current Report on Form 8-K, filed on April 5, 2007 (File No.
001-16043);
|
·
|
Our
Current Report on Form 8-K, filed on April 6, 2007 (File No.
001-16043);
|
·
|
Our
Current Report on Form 8-K, filed on April 11, 2007 (File No.
001-16043);
|
·
|
Our
Current Report on Form 8-K, filed on May 18, 2007 (File No.
001-16043);
|
·
|
Our
Current Report on Form 8-K, filed on June 7, 2007 (File No.
001-16043);
|
·
|
Our
Current Report on Form 8-K, filed on June 28, 2007 (File No.
001-16043);
|
·
|
Our
Current Report on Form 8-K, filed on July 25, 2007 (File No.
001-16043);
|
·
|
Our
Current Report on Form 8-K, filed on July 31, 2007 (File No.
001-16043);
|
·
|
Our
Current Report on Form 8-K, filed on September 13, 2007 (File No.
001-16043);
|
·
|
Our
Current Report on Form 8-K, filed on October 1, 2007 (File No.
001-16043);
|
·
|
The
portions of the Registrant’s Definitive Proxy Statement on Schedule 14A
that are deemed “filed” with the Commission under the Exchange Act, filed
on June 22, 2007;
|
·
|
The
description of our common stock, $0.01 par value per share, which
is
contained in our Registration Statement on Form 8-A, filed on
November 1,
1991, including any amendments or reports filed for the purpose
of
updating such description; and
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The
description of the Rights under the Registrant’s Stockholders’ Rights
Agreement (which are currently transferred with the Registrant’s common
stock) contained in the Registrant’s Registration Statement on Form 8-A
(File No. 000-19529), filed under the Exchange Act, filed on
August 4,
1995, including any amendment or report filed for the purposes
of updating
such description.
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