Delaware
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13-3304550
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(State
or other jurisdiction of
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(I.R.S.
Employer
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incorporation
or organization)
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Identification
Number)
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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,
|
·
|
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,
|
·
|
increase
our authorized capital,
|
·
|
create
any new classes or series of stock with rights senior to the common
stock,
|
·
|
issue
any shares of our 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,
|
·
|
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,
|
·
|
merge
with another entity,
|
·
|
sell
or dispose of any of our assets, including the sale or license
of our
intellectual property,
|
·
|
change
the number of directors,
|
·
|
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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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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·
|
seek
a buyer for all or a portion of our business;
or
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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;
|
·
|
adverse
results in preclinical safety or toxicity
studies;
|
·
|
lower
than expected recruitment or retention rates of subjects in a clinical
trial;
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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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longer
treatment time required to demonstrate effectiveness or determine
the
appropriate product dose;
|
·
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lack
of sufficient supplies of the product
candidate;
|
·
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adverse
medical events or side effects in treated
subjects;
|
·
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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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·
|
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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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;
|
·
|
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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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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·
|
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;
|
·
|
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;
|
·
|
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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·
|
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;
|
·
|
warning
letters;
|
·
|
civil
or criminal penalties;
|
·
|
fines;
|
·
|
injunctions;
|
·
|
product
seizures or detentions;
|
·
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import
bans;
|
·
|
voluntary
or mandatory product recalls and publicity
requirements;
|
·
|
suspension
or withdrawal of regulatory
approvals;
|
·
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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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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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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;
|
·
|
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
|
·
|
could
breach, or fail to perform as agreed, under the manufacturing
agreement.
|
·
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attract
and retain skilled scientific and research
personnel;
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·
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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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·
|
be
early entrants to the market; and
|
·
|
manufacture,
market and sell our products, independently or through
collaborations.
|
·
|
incur
debt in excess of $2,000,000;
|
·
|
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;
|
·
|
increase
our authorized capital;
|
·
|
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;
|
·
|
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;
|
·
|
merge
with another entity;
|
·
|
sell
or dispose of any of our assets, including the sale or license of
our
intellectual property;
|
·
|
change
the number of directors;
|
·
|
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.
|
·
|
quarterly
fluctuations in results of
operations;
|
·
|
material
weaknesses in our internal control over financial
reporting;
|
·
|
the
announcement of new products or services by us or
competitors;
|
·
|
sales
of common stock by existing stockholders or the perception that
these
sales may occur;
|
·
|
adverse
judgments or settlements obligating the combined company to pay
damages;
|
·
|
negative
publicity;
|
·
|
loss
of key personnel;
|
·
|
developments
concerning proprietary rights, including patents and litigation
matters;
and
|
·
|
clinical
trial or regulatory developments in both the United States and
foreign
countries.
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SHARES
|
|
SHARES
|
|||||||||||||
|
BENEFICALLY
|
|
BENEFICALLY
|
|||||||||||||
|
OWNED
BEFORE
|
SHARES
|
OWNED
AFTER
|
|||||||||||||
|
OFFERING(1)
|
BEING
|
OFFERING(2)
|
|||||||||||||
SELLING
STOCKHOLDER
|
NUMBER
|
PERCENT
|
OFFERED
|
NUMBER
|
PERCENT
|
|||||||||||
Baker/Tisch
Investments, L.P. (3)
|
70,971
|
2.67
|
%
|
3,397
|
67,574
|
2.55
|
%
|
|||||||||
Baker
Biotech Fund I, L.P.(4)
|
2,740,840
|
51.45
|
%
|
131,208
|
2,609,632
|
50.22
|
%
|
|||||||||
Baker
Brothers Life Sciences, L.P. (5)
|
7,438,590
|
74.20
|
%
|
356,095
|
7,082,495
|
73.25
|
%
|
|||||||||
14159,
L.P. (6)
|
240,276
|
8.5
|
%
|
11,502
|
228,774
|
8.13
|
%
|
|||||||||
Baker
Brothers Investments II, L.P.(7)
|
9,323
|
*
|
%
|
446
|
8,877
|
*
|
%
|
|||||||||
Atticus
Global Advisors, Ltd. L.P. (8)
|
1,750,000
|
40.36
|
%
|
83,775
|
1,666,225
|
39.18
|
%
|
|||||||||
Green
Way Managed Acct. Series, Ltd.(9)
|
250,000
|
8.81
|
%
|
11,968
|
238,032
|
8.43
|
%
|
|||||||||
Rodman
& Renshaw, LLC (10)
|
624,106
|
*
|
%
|
29,877
|
594,229
|
*
|
%
|
(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.
|
(3)
|
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.
|
·
|
ordinary
brokerage transactions and transactions in which the broker-dealer
solicits purchasers;
|
·
|
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;
|
·
|
an
exchange distribution in accordance with the rules of the applicable
exchange;
|
·
|
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
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
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);
|
·
|
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
|
·
|
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.
|
SEC
registration fee
|
|
$
|
83.52 |
|
Accounting
fees and expenses
|
|
$
|
5,000
|
|
Legal
fees and expenses
|
|
$
|
25,000
|
|
TOTAL
|
|
$
|
30,083.52
|
|
(a) |
The
undersigned registrant hereby
undertakes:
|
(1)
|
To
file, during any period in which offers or sales are being made,
a
post-effective amendment to this registration
statement:
|
(i) |
To
include any prospectus required by Section 10(a)(3) of the Securities
Act of 1933;
|
(ii) |
To
reflect in the prospectus any facts or events arising after the
effective
date of the registration statement (or the most recent post-effective
amendment thereof) which, individually or in the aggregate, represent
a
fundamental change in the information set forth in the registration
statement. Notwithstanding the foregoing, any increase or decrease
in
volume of securities offered (if the total dollar value of securities
offered would not exceed that which was registered) and any deviation
from
the low or high end of the estimated maximum offering range may
be
reflected in the form of prospectus filed with the SEC pursuant
to
Rule 424(b) if, in the aggregate, the changes in volume and price
represent no more than a 20% change in the maximum aggregate offering
price set forth in the “Calculation of Registration Fee” table in the
effective registration statement;
and
|
(iii)
|
To
include any material information with respect to the plan of distribution
not previously disclosed in the registration statement or any material
change to such information in the registration
statement.
|
(2)
|
That,
for the purpose of determining any liability under the Securities
Act of
1933, each such post-effective amendment shall be deemed to be
a new
registration statement relating to the securities offered therein,
and the
offering of such securities at that time shall be deemed to be
the initial
bona fide offering thereof.
|
(3)
|
To
remove from registration by means of a post-effective amendment
any of the
securities being registered which remain unsold at the termination
of the
offering.
|
(4)
|
That,
for the purpose of determining liability under the Securities Act
of 1933
to any purchaser:
|
(i) |
Each
prospectus filed by the registrant pursuant to Rule 424(b)(3) shall
be deemed to be part of the registration statement as of the date
the
filed prospectus was deemed part of and included in the registration
statement: and
|
(ii) |
Each
prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5),
or (b)(7) as part of a registration statement in reliance on
Rule 430B relating to an offering made pursuant to
Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing
the information required by section 10(a) of the Securities Act of
1933 shall be deemed to be part of and included in the registration
statement as of the earlier of the date such form of prospectus
is first
used after effectiveness or the date of the first contract of sale
of
securities in the offering described in the prospectus. As provided
in
Rule 430B, for liability purposes of the issuer and any person that
is at that date an underwriter, such date shall be deemed to be
a new
effective date of the registration statement relating to the securities
in
the registration statement to which that prospectus relates, and
the
offering of such securities at that time shall be deemed to be
the initial
bona fide offering thereof. Provided, however, that no statement
made in a
registration statement or prospectus that is part of the registration
statement or made in a document incorporated or deemed incorporated
by
reference into the registration statement or prospectus that is
part of
the registration statement will, as to a purchaser with a time
of contract
of sale prior to such effective date, supersede or modify any statement
that was made in the registration statement or prospectus that
was part of
the registration statement or made in any such document immediately
prior
to such effective date.
|
(b) |
The
undersigned registrant hereby undertakes that, for purposes of
determining
any liability under the Securities Act of 1933, each filing of
the
registrant’s annual report pursuant to Section 13(a) or
Section 15(d) of the Securities Exchange Act of 1934 (and, where
applicable, each filing of an employee benefit plan’s annual report
pursuant to section 15(d) of the Securities Exchange Act of
1934) that is incorporated by reference in the registration statement
shall be deemed to be a new registration statement relating to
the
securities offered therein, and the offering of such securities
at that
time shall be deemed to be the initial bona fide offering
thereof.
|
(c) |
Insofar
as indemnification for liabilities arising under the Securities
Act of
1933 may be permitted to directors, officers and controlling persons
of
the registrant pursuant to the foregoing provisions, or otherwise,
the
registrant has been advised that in the opinion of the Securities
and
Exchange Commission such indemnification is against public policy
as
expressed in the Securities Act and is, therefore, unenforceable.
In the
event that a claim for indemnification against such liabilities
(other
than the payment by the registrant of expenses incurred or paid
by a
director, officer or controlling person of the registrant in the
successful defense of any action, suit or proceeding) is asserted
by such
director, officer or controlling person in connection with the
securities
being registered, the registrant will, unless in the opinion of
its
counsel the matter has been settled by controlling precedent, submit
to a
court of appropriate jurisdiction the question whether such
indemnification by it is against public policy as expressed in
the
Securities Act and will be governed by the final adjudication of
such
issue.
|
SYNVISTA THERAPEUTICS, INC. | ||
|
|
|
By: | /s/ Noah Berkowitz | |
Noah Berkowitz, M.D., Ph.D. |
||
President and Chief Executive Officer |
Signature
|
Title
|
Date
|
||
/s/
Noah Berkowitz
|
President,
Chief Executive Officer and Director
|
September
28, 2007
|
||
Noah
Berkowitz, M.D., Ph.D.
|
||||
*
|
(principal
financial and accounting officer)
|
September
28, 2007
|
||
Jeffrey
P. Stein, CPA
|
||||
*
|
Director
|
September
28, 2007
|
||
Wayne
P. Yetter
|
||||
*
|
Director
|
September
28, 2007
|
||
Mary
C. Tanner
|
||||
/s/
John F. Bedard
|
Director
|
September
28, 2007
|
||
John
F. Bedard
|
||||
*By
Noah Berkowitz
|
||||
Attorney-in-fact |
EXHIBIT
NUMBER
|
DESCRIPTION
OF DOCUMENT
|
|
4.1
|
Form
of Series 1 Common Stock Purchase Warrant. (Incorporated by reference
to
Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on October
5, 2000, SEC File Number 001-16043.)
|
|
4.2
|
Form
of Series 2 Common Stock Purchase Warrant. (Incorporated by reference
to
Exhibit 4.3 to the Company’s Current Report on Form 8-K filed on October
5, 2000, SEC File Number 001-16043.)
|
|
4.3
|
Form
of Common Stock Purchase Warrant, dated July 2, 2004. (Incorporated
by
reference to Exhibit 4.10 to the Company’s Annual Report on Form 10-K for
the year ended December 31, 2004, SEC File Number
000-16043.)
|
|
4.4
|
Form
of Common Stock Purchase Warrant, dated January 5, 2005. (Incorporated
by
reference to Exhibit 4.11 to the Company’s Annual Report on Form 10-K for
the year ended December 31, 2004, SEC File Number
000-16043.)
|
|
4.5
|
Amended
and Restated Stockholder Rights Agreement between Synvista Therapeutics,
Inc. and American Stock Transfer & Trust Company, as Rights Agent,
dated as of July 27, 2005. (Incorporated by reference to Exhibit
4.1 to
the Company’s Registration Statement on Form 8-A/A filed on July 27, 2005,
SEC File Number 001-16043.)
|
|
4.6
|
Registration
Rights Agreement by and between Synvista Therapeutics, Inc. and
the
Purchasers named therein dated as of April 19, 2006. (Incorporated
by
reference to Exhibit 10.2 to the Registrant’s Registration Statement on
Form S-3 filed on May 31, 2006, SEC File No. 333-134584.)
|
|
4.7
|
Form
of Warrant issued to investors pursuant to the Securities Purchase
Agreement dated as of April 19, 2006, by and between the Company
and the
Purchasers named therein. (Incorporated by reference to Exhibit
10.27 to
the Registrant’s Registration Statement on Form S-3 filed on May 31, 2006,
SEC File No. 333-134584.)
|
|
4.8
|
Registration
Rights Agreement by and between Synvista Therapeutics, Inc. and
the
Purchasers named therein, dated as of September 13, 2006. (Incorporated
by
reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K
filed on September 19, 2006, SEC File No. 001-16043.)
|
|
4.9
|
Form
of Warrant issued to investors pursuant to the Securities Purchase
Agreement, dated as of September 13, 2006, by and between the
Company and
the Purchasers named therein. (Incorporated by reference to Exhibit
10.3
to the Registrant’s Current Report on Form 8-K filed on September 19,
2006, SEC File No. 001-16043.)
|
|
4.10
|
Series
B Preferred Stock and Warrant Purchase Agreement, as amended,
among
Synvista Therapeutics, Inc. and the Purchasers named therein,
dated as of
April 5, 2007 (Incorporated by reference to Annex A to the Company’s
Definitive Proxy Statement filed on June 22, 2007), SEC File
No.
001-16043.)
|
|
4.11
|
Form
of Preferred Stock Purchase Warrant issued to investors pursuant
to the
Series B Preferred Stock and Warrant Purchase Agreement. (Incorporated
by
reference to Exhibit 10.4 of Registrant’s Current Report on Form 8-K filed
on April 11, 2007, SEC File No. 001-16043.)
|
|
4.12
|
Registration
Rights Agreement by and between Synvista Therapeutics, Inc and
the
Purchasers named therein dated as of July 25, 2007. (Incorporated
by
reference to Exhibit 10.3 of Registrant’s Current Report on Form 8-K,
filed on April 11, 2007, SEC File No. 001-16043.)
|
|
5.1
|
Opinion
of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. (Incorporated
by
reference to Exhibit 5.1 of Registrant's Form S-3, filed on September
7,
2007, SEC File No. 333-145935.)
|
|
23.1*
|
Consent
of J.H. Cohn LLP.
|
|
23.2
|
Consent
of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. (Included
in
opinion of counsel filed as Exhibit 5.1). (Incorporated by reference
to
Exhibit 5.1 of Registrant's Form S-3, filed on September 7, 2007,
SEC File
No. 333-145935.)
|
|
24.1
|
Power
of Attorney. (Incorporated by reference to signature page by
Registrant's
Form S-3, filed on September 7, 2007, SEC File No.
333-145935.)
|