As
filed with the Securities and Exchange Commission
on October 22, 2007 |
Registration
No. ______________
|
Delaware
|
2834
|
88-0363465
|
(State
or other jurisdiction of
|
(Primary
Standard Industrial
Classification
Code Number)
|
(I.R.S.
Employer
|
Incorporation
or organization)
|
Identification
No.)
|
2850
Telegraph Ave.
Berkeley,
CA 94705
(510)
281-7700
|
(Address
and telephone number of principal executive offices and principal
place of
business)
|
Mr.
Peter M. Strumph
Chief
Executive Officer
Nile
Therapeutics, Inc.
2850
Telegraph Ave.,
Suite 310
Berkeley,
CA 94705
Telephone:
(510)
281-7700
Facsimile:
(510) 288-1310
(Name
and address of agent for service)
|
Copies
to:
Ira
L. Kotel, Esq.
Dickstein
Shapiro, LLP
1177
Avenue of the Americas
New
York, NY 10036
Telephone:
(212) 277-6686
Facsimile:
(212) 277-6501
|
Title
of each class of
securities
to be registered
|
Number
of shares to be registered (1)
|
Proposed
maximum offering price per unit
|
Proposed
maximum
aggregate
offering
price
|
Amount
of
registration
fee
|
|||||||||
Common
stock, par value $.001 per share
|
8,641,999
|
$
|
4.40
|
(2)
|
$
|
38,024,796
|
$
|
1,167
|
|||||
Common
stock, par value $.001 per share
|
168,377
|
(3)
|
$
|
4.40
|
(2)
|
$
|
740,859
|
$
|
23
|
||||
Total
|
8,810,376
|
$
|
4.40
|
$
|
38,765,655
|
$
|
1,190
|
(1) |
This
registration statement shall also cover any additional shares of
common
stock that shall become issuable by reason of any stock dividend,
stock
split, recapitalization or other similar transaction effected without
the
receipt of consideration that results in an increase in the number
of the
outstanding shares of common stock.
|
(2) |
Estimated
solely for the purpose of calculating the registration fee in accordance
with Rule 457(c) of the Securities Act of 1933, as amended, based
upon the
average of the bid and asked price of our Common Stock on October
18,
2007, a date within five business days prior to the date of filing
the
registration statement, on the OTC Bulletin
Board.
|
(3) |
Represents
shares of common stock issuable upon exercise of outstanding
warrants.
|
SUMMARY
|
|
5
|
THE
OFFERING
|
8
|
|
RISK
FACTORS
|
|
9
|
SAFE
HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT
OF
1995
|
18
|
|
MANAGEMENT’S
DISCUSSION AND PLAN OF OPERATIONS
|
|
20
|
DESCRIPTION
OF BUSINESS
|
22
|
|
MANAGEMENT
|
|
28
|
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
|
|
36
|
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS
|
|
38
|
MARKET
FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
|
|
38
|
USE
OF PROCEEDS
|
|
40
|
DETERMINATION
OF OFFERING PRICE
|
|
40
|
SELLING
STOCKHOLDERS
|
|
40
|
PLAN
OF DISTRIBUTION
|
|
45
|
DESCRIPTION
OF SECURITIES
|
|
47
|
ANTI
TAKEOVER EFFECTS OF CERTAIN PROVISIONS OF OUR CERTIFICATE OF INCORPORATION
AND DELAWARE LAW
|
|
48
|
DISCLOSURE
OF SEC POSITION ON INDEMNIFICATION FOR SECURITIES ACT
LIABILITIES
|
|
48
|
CHANGES
IN AND DISAGREEMENT WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE
|
|
48
|
ABOUT
THIS PROSPECTUS
|
|
49
|
VALIDITY
OF COMMON STOCK
|
|
49
|
EXPERTS
|
|
49
|
TRANSFER
AGENT
|
|
49
|
WHERE
YOU CAN FIND MORE INFORMATION
|
49
|
|
GLOSSARY
OF TERMS
|
|
50
|
FINANCIAL
STATEMENTS
|
|
F-1
|
|
Common
stock offered
|
8,810,376
shares
|
|
|
|
|
Common
stock outstanding before the offering(1)
|
24,099,716
shares
|
|
|
|
Common
stock outstanding after the offering(2)
|
24,268,053
shares
|
|
Use
of Proceeds
|
We
will receive none of the proceeds from the sale of the shares by
the
selling stockholders, except for the warrant exercise price upon
exercise
of the warrants, which would be used for working capital and other
general
corporate purposes
|
|
|
OTC
Bulletin Board Symbol
|
NILT.OB
|
(1)
|
Based
on the number of shares outstanding as of September 30,
2007.
|
(2) |
Assumes
the issuance of all shares offered hereby that are issuable upon
exercise
of warrants.
|
· |
continue
to undertake pre-clinical development and clinical trials for our
product
candidates;
|
· |
seek
regulatory approvals for our product
candidates;
|
· |
in-license
or otherwise acquire additional products or product
candidates;
|
· |
implement
additional internal systems and infrastructure;
and
|
· |
hire
additional personnel.
|
· |
continuing
to undertake pre-clinical development and clinical trials for our
product
candidates;
|
· |
participating
in regulatory approval processes;
|
· |
formulating
and manufacturing products; and
|
· |
conducting
sales and marketing activities.
|
· |
delay
commercialization of, and our ability to derive product revenues
from, our
product candidates;
|
· |
impose
costly procedures on us; or
|
· |
diminish
any competitive advantages that we may otherwise
enjoy.
|
· |
perceptions
by members of the health care community, including physicians, about
the
safety and effectiveness of our
drugs;
|
· |
cost-effectiveness
of our products relative to competing
products;
|
· |
availability
of reimbursement for our products from government or other healthcare
payers; and
|
· |
effectiveness
of marketing and distribution efforts by us and our licensees and
distributors, if any.
|
· |
We
may be unable to identify manufacturers on acceptable terms or at
all,
because the number of potential manufacturers is limited and subsequent
to
NDA approval, the FDA must approve any replacement contractor. This
approval would require new testing and compliance inspections. In
addition, a new manufacturer may have to be educated in, or develop
substantially equivalent processes for, production of our products
after
receipt of FDA approval, if any.
|
· |
Our
third-party manufacturers might be unable to formulate and manufacture
our
drugs in the volume and of the quality required to meet our clinical
and
commercial needs, if any.
|
· |
Our
future contract manufacturers may not perform as agreed or may not
remain
in the contract manufacturing business for the time required to supply
our
clinical trials or to successfully produce, store and distribute
our
products.
|
· |
Drug
manufacturers are subject to ongoing periodic unannounced inspection
by
the FDA, the Drug Enforcement Agency, and corresponding state agencies
to
ensure strict compliance with good manufacturing practice and other
government regulations and corresponding foreign standards. We do
not have
control over third-party manufacturers’ compliance with these regulations
and standards.
|
· |
developing
drugs;
|
· |
undertaking
pre-clinical testing and human clinical
trials;
|
· |
obtaining
FDA and other regulatory approvals of
drugs;
|
· |
formulating
and manufacturing drugs; and
|
· |
launching,
marketing and selling drugs.
|
· |
the
degree and range of protection any patents will afford us against
competitors including whether third parties will find ways to invalidate
or otherwise circumvent our
patents;
|
· |
if
and when patents will issue;
|
· |
whether
or not others will obtain patents claiming aspects similar to those
covered by our patents and patent applications;
or
|
· |
whether
we will need to initiate litigation or administrative proceedings
which
may be costly whether we win or
lose.
|
· |
obtain
licenses, which may not be available on commercially reasonable terms,
if
at all;
|
· |
redesign
our products or processes to avoid
infringement;
|
· |
stop
using the subject matter claimed in the patents held by
others;
|
· |
pay
damages; or
|
· |
defend
litigation or administrative proceedings which may be costly whether
we
win or lose, and which could result in a substantial diversion of
our
valuable management resources.
|
· |
government
and health administration
authorities;
|
· |
private
health maintenance organizations and health insurers;
and
|
· |
other
healthcare payers.
|
|
·
|
the
risk that we may not successfully develop and market our products,
and
even if we do, we may not become
profitable;
|
|
·
|
risks
relating to the progress of our research and
development;
|
|
·
|
risks
relating to significant, time-consuming and costly research and
development efforts, including pre-clinical studies, clinical trials
and
testing, and the risk that clinical trials may be delayed, halted
or fail;
|
|
·
|
risks
relating to the rigorous regulatory approval process required for
any
products that we may develop independently, with our development
partners
or in connection with any of our collaboration arrangements;
|
|
·
|
the
risk that changes in the national or international political and
regulatory environment may make it more difficult to gain U.S. Food
and
Drug Administration, (FDA) or other regulatory approval of our drug
product candidates;
|
|
·
|
risks
that the FDA or other regulatory authorities may not accept any
applications we file;
|
|
·
|
risks
that the FDA or other regulatory authorities may withhold or delay
consideration of any applications that we file or limit such applications
to particular indications or apply other label
limitations;
|
|
·
|
risks
that, after acceptance and review of applications that we file, the
FDA or
other regulatory authorities will not approve the marketing and sale
of
our drug product candidates;
|
|
·
|
risks
relating to our drug manufacturing operations, including those of
our
third-party suppliers and contract
manufacturers;
|
|
·
|
risks
relating to the ability of our development partners and third-party
suppliers of materials, drug substance and related components to
provide
us with adequate supplies and expertise to support manufacture of
drug
product for initiation and completion of our pre-clinical and clinical
studies;
|
|
·
|
risks
relating to the transfer of our manufacturing technology to third-party
contract manufacturers;
|
|
·
|
the
risk that recurring losses, negative cash flows and the inability
to raise
additional capital could threaten our ability to continue as a going
concern;
|
|
·
|
other
risks and uncertainties detailed in “Risk Factors” and in the documents
incorporated by reference in this registration
statement.
|
· |
operating
expenses, including expanded general and administrative expenses;
and
|
· |
research
and development expenses, including the costs incurred with respect
to
applications to conduct clinical trials in the U.S. for our lead
product,
CD-NP, and pre-clinical testing of
2NTX-99.
|
·
|
the
progress of research activities;
|
·
|
the
number and scope of research
programs;
|
·
|
the
progress of pre-clinical and clinical development
activities;
|
·
|
the
progress of the development efforts of parties with whom we may enter
into
research and development agreements;
|
·
|
the
amount of sub-licensing revenue
earned;
|
·
|
our
ability to maintain current research and development programs and
to
establish new research and development and licensing
arrangements;
|
·
|
the
cost involved in prosecuting and enforcing patent claims and other
intellectual property rights; and
|
·
|
the
cost and timing of regulatory
approvals.
|
· |
preclinical
laboratory tests, animal studies, and formulation
studies;
|
· |
submission
to the FDA of an IND for human clinical testing, which must become
effective before human clinical trials may
begin;
|
· |
adequate
and well-controlled human clinical trials to establish the safety
and
efficacy of the drug for each
indication;
|
· |
submission
to the FDA of an NDA;
|
· |
satisfactory
completion of an FDA inspection of the manufacturing facility or
facilities at which the drug is produced to assess compliance with
current
good manufacturing practices, or cGMPs;
and
|
· |
FDA
review and approval of the NDA.
|
Name
|
Age
|
Positions
|
Peter
M. Strumph
|
42
|
Chief
Executive Officer and Director
|
Daron
Evans
|
34
|
Chief
Financial Officer
|
Jennifer
Hodge
|
39
|
Vice
President, Development
|
Pedro
Granadillo
|
60
|
Director
|
Peter
M. Kash
|
46
|
Director
|
Joshua
A. Kazam
|
30
|
Director
|
David
M. Tanen
|
36
|
Secretary
and Director
|
Paul
Mieyal
|
38
|
Director
|
Scott
L. Navins
|
36
|
Treasurer
|
Name
and
Principal
Position
|
Year
|
Salary
|
Bonus
(1)
|
|
Option
Awards (2)
|
Total
|
|||||||||||||
Peter
M. Strumph
Chief
Executive Officer
|
2006
|
$
|
-0-
|
$
|
-0-
|
(3)
|
|
$
|
-0-
|
$
|
-0-
|
||||||||
Daron
Evans
Chief
Financial Officer
|
2006
|
$
|
-0-
|
$
|
-0-
|
(4)
|
|
$
|
-0-
|
$
|
-0-
|
||||||||
Jennifer
Hodge
Vice
President, Development
|
2006
|
$
|
-0-
|
$
|
-0-
|
(5)
|
|
$
|
-0-
|
$
|
-0-
|
||||||||
Allan
Gordon (6)
Chief
Executive Officer
|
2006
|
$
|
-0-
|
$
|
-0-
|
$
|
-0-
|
$
|
-0-
|
||||||||||
Joshua
Kazam (7)
President
|
2006
|
$
|
-0-
|
$
|
-0-
|
$
|
-0-
|
$
|
-0-
|
||||||||||
Geoffrey
Alison (8)
President
|
2006
|
$
|
-0-
|
$
|
-0-
|
$
|
-0-
|
$
|
-0-
|
Name
of Beneficial Owner
|
Shares
of Our
Common
Stock
Beneficially
Owned (#)(1)
|
Percentage
of Our
Common
Stock
Beneficially
Owned (%)(1)
|
Peter
M. Strumph (2)
2850
Telegraph Avenue, Suite #310
Berkeley,
CA 94705
|
0
|
*
|
Daron
Evans (3)
2850
Telegraph Avenue, Suite #310
Berkeley,
CA 94705
|
0
|
*
|
Wexford
Capital LLC (4)
411
West Putnam Avenue
Greenwich,
CT 06830
|
2,623,619
|
10.88%
|
RIT
Capital Partners, Plc
27
St. James Place
London,
UK SW1A 1NR
|
1,741,690
|
7.23%
|
David
M. Tanen (5)
689
Fifth Avenue, 14th Floor
New
York, NY 10022
|
1,507,705
|
6.26%
|
Peter
M. Kash (6)
689
Fifth Avenue, 14th Floor
New
York, NY 10022
|
1,492,796
|
6.19%
|
Joshua
A. Kazam (7)
689
Fifth Avenue, 14th Floor
New
York, NY 10022
|
1,231,820
|
5.11%
|
Scott
L. Navins
689
Fifth Avenue, 14th Floor
New
York, NY 10022
|
206,912
|
*
|
Pedro
Granadillo
7218
Tory Lane
Naples,
FL 34108
|
27,588
|
*
|
Paul
Mieyal
411
West Putnam Avenue
Greenwich,
CT 06830
|
0
|
*
|
Dr.
Allan Gordon (8)
6936
Bristol Dr.
Berkeley,
CA 94705
|
593,743
|
2.46%
|
Directors
and named executive officers as a group, 8 individuals (9)
|
4,853,652
|
19.65%
|
Quarter
ended
|
High
Bid
|
Low
Bid
|
March
31, 2005
|
6.00
|
5.10
|
June
30, 2005
|
6.00
|
5.00
|
September
30, 2005
|
NA
|
NA
|
December
30, 2005
|
6.50
|
4.10
|
March
31, 2006
|
6.90
|
3.50
|
June
30, 2006
|
NA
|
NA
|
September
29, 2006
|
7.50
|
3.50
|
December
29, 2006
|
6.50
|
3.50
|
March
30, 2007
|
3.50
|
0.77
|
June
29, 2007
|
2.05
|
2.00
|
September
28, 2007
|
4.30
|
1.15
|
·
|
that
is a “reported security” as that term is defined by SEC rule, including
securities listed on the Nasdaq Stock Market, the New York Stock
Exchange
or the American Stock Exchange,
|
·
|
that
is issued by an investment company,
|
·
|
that
is a put or call option issued by the Options Clearing House,
|
·
|
that
has a price of $5.00 or more,
|
·
|
that
is registered, or approved for registration upon notice of issuance,
on a
national securities exchange that makes transaction reports available,
subject to restrictions provided in the
rule,
|
·
|
that
is authorized, or approved for authorization upon notice of issuance,
for
quotation on NASDAQ, subject to restrictions provided in the rule,
or
|
·
|
whose
issuer has (i) net tangible assets of more than $2,000,000 if the
issuer
has been in business for at least 3 continuous years, and $5,000,000
if
the issuer has been in business less than 3 years, or (ii) average
revenue
of at least $6,000,000 for the last 3 years.
|
Selling
Stockholder
|
Shares
Beneficially Owned Before Offering (a)
|
Maximum
Number of
Shares
to be Sold
Pursuant
to this
Prospectus
|
Number
of Shares Offered by Selling Stockholder upon Exercise of Certain
Warrants
|
Percentage
Beneficial Ownership of Voting Securities After
Offering (b)
|
A.
Lapidot Pharmaceuticals (1)
|
17,518
|
17,518
|
-
|
*
|
Alan
Mendelson
|
11,576
|
10,524
|
1,052
|
*
|
Albert
H. Keller
|
37,703
|
36,651
|
1,052
|
*
|
Albert
Milstein
|
23,153
|
21,049
|
2,104
|
*
|
Albert
Reichman
|
55,016
|
50,806
|
4,210
|
*
|
Arnold
Feld
|
27,588
|
27,588
|
-
|
*
|
Aviv
Raiz
|
34,734
|
31,577
|
3,157
|
*
|
Barry
Goodman
|
11,576
|
10,524
|
1,052
|
*
|
Beck
Family Partners, LP (2)
|
110,236
|
108,132
|
2,104
|
*
|
Beechwood
Ventures, LLC (3)
|
40,570
|
38,466
|
2,104
|
*
|
Bonnie
Kazam (4)
|
73,648
|
10,524
|
1,052
|
*
|
Bristol
Investment Fund, Ltd. (5)
|
230,456
|
192,343
|
10,525
|
*
|
Bruce
Lipnick
|
28,993
|
27,941
|
1,052
|
*
|
Clal
Insurance, Ltd. (6)
|
174,157
|
174,157
|
-
|
*
|
Dana
Freyer
|
11,576
|
10,524
|
1,052
|
*
|
Daniel
Nissanoff
|
11,576
|
10,524
|
1,052
|
*
|
David
and Susan Wilstein, TTEES of the Century Trust (7)
|
164,717
|
38,466
|
2,104
|
*
|
Dennis
Lee Berman
|
17,416
|
17,416
|
-
|
*
|
Dikla
Insurance Company Ltd. - Nostro (8)
|
3,481
|
3,481
|
-
|
*
|
Dikla
Insurance Company Ltd. - Siudi (8)
|
10,447
|
10,447
|
-
|
*
|
Diversified
Fund, Ltd. (9)
|
20,283
|
19,231
|
1,052
|
*
|
ECOrg,
LLC (10)
|
104,205
|
94,732
|
9,473
|
*
|
Ed
Steinberg
|
20,286
|
19,234
|
1,052
|
*
|
Ezra
Kazam (11)
|
11,576
|
10,524
|
1,052
|
*
|
GMM
Capital, LLC (12)
|
335,515
|
132,669
|
4,210
|
1.39%
|
Harel
Insurance Company Ltd. - Clali (8)
|
13,932
|
13,932
|
-
|
*
|
Harel
Insurance Company Ltd. - Mishtatfot (8)
|
104,499
|
104,499
|
-
|
*
|
Harel
Insurance Company Ltd. - Nostro (8)
|
45,283
|
45,283
|
-
|
*
|
Harel
Pension Fund Management Ltd. (8)
|
17,416
|
17,416
|
-
|
*
|
Harel
Provident Funds, Ltd. - Taoz (8)
|
27,867
|
27,867
|
-
|
*
|
Harel
Provident Funds, Ltd.-Gmisha (8)
|
10,447
|
10,447
|
-
|
*
|
Harel
Provident Funds, Ltd.-Keren Hishtalmut (8)
|
10,447
|
10,447
|
-
|
*
|
Harel
Provident Funds, Ltd.-Otzma (8)
|
104,499
|
104,499
|
-
|
*
|
Henry
Rothman
|
23,153
|
21,049
|
2,104
|
*
|
High
Glen Properties. Ltd. (13)
|
17,926
|
17,926
|
-
|
*
|
Hila
Karah
|
11,576
|
10,524
|
1,052
|
*
|
HSBC
Private Bank (Suisse) SA
|
348,336
|
348,336
|
-
|
1.45%
|
Inversiones
Mirachonda, SL (14)
|
102,643
|
38,466
|
2,104
|
*
|
Iota
Investors LLC (15)
|
1,926,944
|
1,910,103
|
16,841
|
7.99%
|
Irvin
Kessler
|
133,395
|
129,185
|
4,210
|
*
|
Ivan
and Lisa Kauffman Family Trust (16)
|
115,782
|
105,257
|
10,525
|
*
|
Jacob
Gottlieb
|
194,117
|
126,310
|
12,631
|
*
|
JD
Management Partners (17)
|
17,416
|
17,416
|
-
|
*
|
Jeff
Berman
|
17,416
|
17,416
|
-
|
*
|
Jonathan
Abodeely
|
17,416
|
17,416
|
-
|
*
|
Joseph
Sitt
|
57,987
|
55,883
|
2,104
|
*
|
Jospeh
Tabak
|
23,153
|
21,049
|
2,104
|
*
|
Kanfei
Investments, LLC (18)
|
41,086
|
38,982
|
2,104
|
*
|
Larich
Assoc. (19)
|
20,283
|
19,231
|
1,052
|
*
|
Leiden
Overseas (20)
|
23,153
|
21,049
|
2,104
|
*
|
Leon
Recanati
|
46,312
|
42,102
|
4,210
|
*
|
Leonard
Grunstein
|
26,123
|
26,123
|
-
|
*
|
Leumi
Overseas Trust Corporation Limited As TTEE for the BTL Trust (21)
|
81,145
|
76,935
|
4,210
|
*
|
Life
Science Capital (22)
|
87,082
|
87,082
|
-
|
*
|
Linda
Ann Hamilton TTEE, Linda Ann Hamilton Rev. Trust
UAD 08-08-2000 (23)
|
20,286
|
19,234
|
1,052
|
*
|
Lyon
Roth
|
17,416
|
17,416
|
-
|
*
|
Martin
Granoff
|
115,782
|
105,257
|
10,525
|
*
|
Mehmet
Oz
|
40,570
|
38,466
|
2,104
|
*
|
Michael
Chisek
|
17,416
|
17,416
|
-
|
*
|
Michael
Crockett
|
11,035
|
11,035
|
-
|
*
|
Millennium
Partners
|
376,884
|
376,884
|
-
|
1.56%
|
Naftali
Investments, Ltd. (24)
|
28,982
|
27,930
|
1,052
|
*
|
Norman
Kraftchuk & Associates Ltd.
(The
Rose Corporation) (25)
|
8,704
|
8,704
|
-
|
*
|
Novatrust
Ltd. As TTEES of the Sirius Trust (26)
|
451,160
|
192,340
|
10,525
|
1.87%
|
Pedro
Granadillo (27)
|
27,588
|
27,588
|
-
|
*
|
Peter
Kash (28)
|
1,492,796
|
10,524
|
1,052
|
8.94%
|
Peter
Kiernan
|
174,168
|
174,168
|
-
|
*
|
Renato
Negrin
|
34,833
|
34,833
|
-
|
*
|
RIT
Capital Partners, Plc. (29)
|
1,741,690
|
1,741,690
|
-
|
7.23%
|
Robert
I. Falk
|
119,712
|
55,535
|
2,104
|
*
|
Robert
Israel
|
15,061
|
14,009
|
1,052
|
*
|
Robert
Klein
|
23,153
|
21,049
|
2,104
|
*
|
Robert
Koffman
|
20,283
|
19,231
|
1,052
|
*
|
Seymour
and Star Sacks
|
9,655
|
9,655
|
-
|
*
|
Shimon
Katz
|
33,647
|
32,595
|
1,052
|
*
|
Speisman
Family 2000, LP (30)
|
20,283
|
19,231
|
1,052
|
*
|
Stahler
Investments, LLC (31)
|
59,018
|
56,914
|
2,104
|
*
|
Stephen
Evans
|
11,311
|
11,311
|
-
|
*
|
Stephen
Thompson
|
27,588
|
27,588
|
-
|
*
|
Steve
Warner
|
11,576
|
10,524
|
1,052
|
*
|
Steven
Koffman
|
20,283
|
19,231
|
1,052
|
*
|
Troy
W. and Allison K. Thacker
|
34,833
|
34,833
|
-
|
*
|
Wechsler
& Co, Inc. (32)
|
46,312
|
42,102
|
4,210
|
*
|
Wexford
Spectrum Investors, LLC (15)
|
696,675
|
696,675
|
-
|
2.89%
|
FCC
Ltd. (33)
|
11,576
|
10,524
|
1,052
|
*
|
Yitzhak
Dankner
|
156,544
|
150,229
|
6,315
|
*
|
(a)
|
Assumes
the exercise of all warrants held by such selling
stockholder.
|
(b)
|
Assumes
the exercise of all warrants
outstanding.
|
(1)
|
Mr.
Ami Lapidot, Chairman of the selling stockholder, holds voting and/or
dispositive power over the shares held by the selling
stockholder.
|
(2)
|
Mr.
Ronald Beck, general partner of the selling stockholder, holds voting
and/or dispositive power over the shares held by the selling
stockholder.
|
(3)
|
Mr.
Kalman Renov, managing member of the selling stockholder, holds voting
and/or dispositive power over the shares held by the selling
stockholder.
|
(4)
|
The
selling stockholder is the mother of Mr. Joshua Kazam, a director
of the
Company, and the spouse of Mr. Ezra Kazam, who is also a selling
stockholder.
|
(5)
|
Mr.
Paul Kessler, managing member of the selling stockholder, holds voting
and/or dispositive power over the shares held by the selling
stockholder.
|
(6)
|
Mr.
Avigdor Kaplan, the CEO of the selling stockholder, holds voting
and/or
dispositive power over the shares held by the selling
stockholder.
|
(7)
|
Mr.
David Wilstein, trustee of the selling stockholder, holds voting
and/or
dispositive power over the shares held by the selling
stockholder.
|
(8)
|
Harel
Insurance Investments and Financial Services Ltd. owns each of the
selling
stockholders except for Dikla Insurance Company Ltd. - Nostro and
Dikla Insurance Company Ltd. - Siudi, both in which Harel holds a
65%
ownership interest in.
|
(9)
|
Ms.
Carlo Pagani, president of the selling stockholder, holds voting
and/or
dispositive power over the shares held by the selling stockholder.
|
(10)
|
Ms.
Linda A. Hamilton, Ms. Mary Tanner Hackney, Mr. Jeffrey L. Dyment
and/or
Ms. Lynn E. Coleman hold voting and/or dispositive power over the
shares
held by the selling stockholder.
|
(11)
|
The
selling stockholder is the father of Mr. Joshua Kazam, a director
of the
Company, and the spouse of Mrs. Bonnie Kazam, who is also listed
as a
selling stockholder.
|
(12)
|
Mr.
Isaac Dabah, managing member of the selling stockholder, holds
voting
and/or dispositive power over the shares held by the selling
stockholder.
|
(13)
|
Mr.
John Ulmer, the President of the selling stockholder, holds voting
and/or
dispositive power over the shares held by the selling
stockholder.
|
(14)
|
Mr.
Jose Luis Diaz-Rio, Director of the selling stockholder, holds voting
and/or dispositive power over the shares held by the selling
stockholder.
|
(15)
|
Wexford
Capital is a registered Investment Advisor and also serves as an
investment advisor or sub-advisor to the members of the selling
stockholders. Mr. Charles E. Davidson and Mr. Joseph M. Jacobs are
controlling members of Wexford Capital hold voting and/or dispositive
power over the shares held by the selling stockholder. A Vice President
of
Wexford Capital, Dr. Paul Mieyal, is one of the Company’s
Directors.
|
(16)
|
Mr.
Joseph Martello, Trustee of the selling shareholder, holds voting
and/or
dispositive power over the shares held by the selling
stockholder.
|
(17)
|
Mr.
Jeffrey L. Dyment, the President of the selling stockholder, holds
voting
and/or dispositive power over the shares held by the selling
stockholder.
|
(18)
|
Mr.
Dov Perlysky, managing member of the selling stockholder, holds voting
and/or dispositive power over the shares held by the selling
stockholder.
|
(19)
|
Mr.
Lawrence Gross and Mr. Richard Hirsch, partners of the selling
stockholder, hold voting and/or dispositive power over the shares
held by
the selling stockholder.
|
(20)
|
Mr.
Shai Pilpel, the Chairman of the selling stockholder, holds voting
and/or
dispositive power over the shares held by the selling
stockholder.
|
(21)
|
Mr.
John Le M. Germain, Director of the selling stockholder, holds voting
and/or dispositive power over the shares held by the selling
stockholder.
|
(22)
|
Mr.
Robert Sinclair, director of the selling stockholder, holds voting
and/or
dispositive power over the shares held by the selling
stockholder.
|
(23)
|
Ms.
Linda A. Hamilton, Trustee, holds voting and/or dispositive power
over the
shares held by the selling stockholder.
|
(24)
|
Mr.
Meir Hadar, President and CEO of the selling stockholder, holds voting
and/or dispositive power over the shares held by the selling
stockholder.
|
(25)
|
Mr.
Norman E. Kraftchuck, President of the selling stockholder, holds
voting
and/or dispositive power over the shares held by the selling
stockholder.
|
(26)
|
Novatrust,
Ltd., trustee of the selling stockholder, holds voting and/or dispositive
power over the shares held by the selling stockholder.
|
(27)
|
The
Selling Stockholder is a director of the Company.
|
(28)
|
The
selling stockholder is a director and substantial stockholder of
the
Company and was a director of Old Nile, a predecessor of the Company.
Excludes 496,589 shares of our common stock held by Mr. Kash’s wife as
custodian for the benefit of each of their four minor children under
the
UGMA and 165,530 shares of our common stock held by the Kash Family
Foundation.
|
(29)
|
Mr.
Duncan Budge, director of the selling stockholder, holds voting and/or
dispositive power over the shares held by the selling
stockholder.
|
(30)
|
Mr.
Aaron Speisman, General Partner of the selling stockholder, holds
voting
and/or dispositive power over the shares held by the selling
stockholder.
|
(31)
|
Ms.
Esther Stahler, managing member of the selling stockholder, holds
voting
and/or dispositive power over the shares held by the selling
stockholder.
|
(32)
|
Norman
J. Wechsler holds voting and/or dispositive power over the shares
held by
the selling stockholder
|
(33)
|
Mr.
Yacoz Reizman, Chairman of the selling stockholder, holds voting
and/or
dispositive power over the shares held by the selling
stockholder.
|
agonist
|
A
drug that can combine with a receptor on a cell to produce a physiological
reaction.
|
atherothromboticg
|
The
formation of a clot in an artery that is characterized by a thickening
and
fatty degeneration of that vessel's inner coat.
|
A
thickening and hardening of the artery walls characterized by fatty
deposits in and fibrosis
of
the inner layer of the arteries.
|
|
cardiovascular
|
Of,
relating to, or involving the heart and blood vessels.
|
chimeric
|
Of
or related to an individual, organ, or part consisting of pieces
of
diverse genetic constitution.
|
claudication
|
Cramping
pain and weakness in the legs and especially the calves on walking
that
disappears after rest and is usually associated with inadequate blood
supply to the muscles.
|
natriuretic
|
Of
or related to the excretion of sodium in the urine.
|
congestive
heart failure
|
Heart
failure in which the heart is unable to maintain adequate circulation
of
blood in the tissues of the body or to pump out the venous blood
returned
to it by the venous circulation resulting in an accumulation of blood
in
the vessels and fluid in the body tissues.
|
diabetic
nephropathy
|
Kidney
disease and resultant kidney function impairment due to the long-standing
effects of diabetes on the glomeruli (capillary blood vessels in
the
kidney which are actively involved in the filtration of the blood).
Features include increased urine protein and declining kidney function.
Severe diabetic nephropathy can lead to kidney failure and end-stage
renal
disease.
|
equimolar
|
Of
or relating to an equal number of moles.
|
hypotension
|
Abnormally
low pressure of the blood.
|
in
vitro
|
Outside
the living body and in an artificial environment.
|
in
vivo
|
In
the living body of a plant or animal.
|
mean
arterial pressure
|
A
measurement that takes account of pumped blood flow in the arteries
and is
the best measure of the pressure of blood pumped to an
organ.
|
metabolic
disease
|
An
illness resulting from the body's malfunction in the chemical changes
in
living cells by which energy is provided for vital processes and
activities and new material is assimilated.
|
microvascular
disease
|
An
illness related to or constituting the part of the circulatory system
made
up of minute vessels.
|
nitric
oxide
|
Synthesized
within cells by NO synthase, NO relaxes smooth muscles and has been
implicated almost universally in the functioning of a variety of
cellular
processes.
|
nitric
oxide-donating properties
|
The
ability to release nitric oxide.
|
pathological
|
Altered
or caused by disease
|
peptide
|
Two
or more amino acids formed by combination of the amino group of one
acid
with the carboxyl group of another.
|
pharmacodynamics
|
A
branch of pharmacology dealing with the reactions between drugs and
living
systems.
|
pharmacokinetics
|
The
study of the bodily absorption, distribution, metabolism, and excretion
of
drugs.
|
pharmacologic
actions
|
The
properties and reactions of drugs especially with relation to their
therapeutic value.
|
platelet
aggregation
|
The
clumping of many small blood-based bodies that generally assists
in blood
clotting by adhering to each other and epithelium.
|
prostacyclin
|
A
cyclic fatty acid that inhibits aggregation of platelets, and dilates
blood vessels.
|
prothrombotic
|
Of
or related to the promotion of blood clot formation.
|
renal
|
Relating
to, involving, affecting, or located in the region of the kidneys.
|
synthetic
|
Of,
relating to, or produced by chemical or biochemical synthesis; produced
artificially.
|
thrombotic
|
Of
or related to blood clot formation.
|
thromboxane
|
A
substance that is produced by platelets, causes constriction of vascular
and bronchial smooth muscle, and promotes blood
clotting.
|
vasculature
|
The
disposition or arrangement of blood vessels in an organ or part of
the
body.
|
vasodilator
|
An
agent that widens the lumen of blood
vessels.
|
|
Page
|
Independent
Auditor's Report
|
F-1
|
Balance
Sheet as of June 30, 2007
|
F-2
|
Statements
of Operations for the six month period ended June 30, 2007 and the
period
from August 1, 2005 (inception) to June 30, 2007
|
F-3
|
Statement
of Stockholders’ Equity (Deficit) for the period from August 1, 2005
(inception) to June 30, 2007
|
F-4
|
Statements
of Cash Flows for the six month period ended June 30, 2007 and the
period
from August 1, 2005 (inception) to June 30, 2007
|
F-5
|
Notes
to Financial Statements
|
F-6
|
ASSETS
|
||||
|
||||
Current
assets
|
||||
Note
receivable - employee, current portion
|
15,559
|
|||
Prepaid
expenses
|
26,760
|
|||
|
207,513
|
|||
|
||||
Property
and equipment, net of accumulated
|
||||
depreciation
of $4,774
|
59,674
|
|||
Note
receivable - employee, net of current portion
|
31,117
|
|||
Intangible
assets, net of accumulated
|
||||
amortization
of $1,807
|
41,511
|
|||
Deposits
|
33,400
|
|||
|
$
|
373,215
|
||
|
||||
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
||||
|
||||
Current
liabilities
|
||||
Accounts
payable and accrued expenses
|
$
|
804,313
|
||
Accrued
interest - convertible notes payable
|
302,466
|
|||
Due
to related party
|
84,109
|
|||
|
1,190,888
|
|||
|
||||
Convertible
notes payable
|
4,000,000
|
|||
|
5,190,888
|
|||
|
||||
Commitments
and contingencies
|
||||
(Notes
1, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12)
|
||||
|
||||
Stockholders'
equity (deficit)
|
||||
|
||||
Common
stock, $.001 par value; 25,000,000 shares
|
||||
authorized,
5,000,000 issued and outstanding
|
5,000
|
|||
Additional
paid-in capital
|
7,167
|
|||
Deficit
accumulated during the development stage
|
(4,829,840
|
)
|
||
|
(4,817,673
|
)
|
||
|
$
|
373,215
|
|
Six
months ended
June 30, 2007
|
Period
from
August , 205
(inception)
through
June
30, 2007
|
|||||
Revenues
|
$
|
-
|
$
|
380,835
|
|||
Grant
income
|
|||||||
|
|||||||
Operating
expenses
|
|||||||
Research
and development
|
1,421,277
|
4,130,683 | |||||
General
and administrative
|
721,496
|
901,353 | |||||
|
|||||||
|
2,142,773
|
5,032,036 | |||||
|
|||||||
Loss
from operations
|
(2,142,773
|
)
|
(4,651,201 | ) | |||
|
|||||||
Interest
income
|
23,962
|
123,827 | |||||
Interest
expense
|
(119,014
|
)
|
(302,466 | ) | |||
|
|||||||
Net
loss
|
$
|
(2,237,825
|
)
|
$
|
(4,829,840
|
)
|
|
|
|
|
|
|
|
|
|
|
|||||||
|
|
|
|
|
|
|
|
Common
Stock
|
||||||||||||||||
Shares
|
Amount
|
Additional
paid-in
capital
|
Deficit
accumulated
during
the
development
stage |
Total
|
||||||||||||
Issuance
of common
stock
to founders at
$0.001
per share
|
5,000,000
|
$
|
5,000
|
$
|
-
|
$
|
-
|
$
|
5,000
|
|||||||
|
||||||||||||||||
Founders'
shares
returned
to treasury
|
(500,000
|
)
|
-
|
-
|
-
|
-
|
||||||||||
|
||||||||||||||||
Issuance
of common
stock
to licensor at $0.001 pershare
|
500,000
|
-
|
500
|
500
|
||||||||||||
|
||||||||||||||||
Issuance
of stock
options
for services at $0.25
|
-
|
-
|
10,000
|
-
|
10,000
|
|||||||||||
|
||||||||||||||||
Net
loss, period from
August
1, 2005 (inception) to
December
31, 2006
|
-
|
-
|
-
|
(2,592,015
|
)
|
(2,592,015
|
)
|
|||||||||
|
||||||||||||||||
Balance
at December 31, 2006
|
5,000,000
|
5,000
|
10,500
|
(2,592,015
|
)
|
(2,576,515
|
)
|
|||||||||
|
||||||||||||||||
Net
loss, period from
January
1, 2007 to June 30, 2007
|
-
|
-
|
-
|
(2,237,825
|
)
|
(2,237,825
|
)
|
|||||||||
|
||||||||||||||||
Cancellation
of stock
options
issued in 2006 at $0.25
|
-
|
-
|
(3,333
|
)
|
-
|
(3,333
|
)
|
|||||||||
|
||||||||||||||||
Balance
at June 30, 2007
|
5,000,000
|
$
|
5,000
|
$
|
7,167
|
$
|
(4,829,840
|
)
|
$
|
(4,817,673
|
)
|
|
Six
months ended
June 30, 2007
|
Period
from
August 1, 2005
(inception)
through
June
30, 2007
|
|||||
Cash
flows from operating activities
|
|
|
|||||
Net
loss
|
$
|
(2,237,825
|
)
|
$
|
(4,829,840
|
)
|
|
Adjustments
to reconcile net loss to net
cash
used in operating activities
|
|||||||
Depreciation
and amortization
|
6,227
|
6,581
|
|||||
Stock
based compensation
|
(3,333
|
)
|
7,167
|
||||
|
|||||||
Changes
in operating assets and liabilities
|
|||||||
Increase
in prepaid expenses
|
(26,760
|
)
|
(26,760
|
)
|
|||
Increase
in deposits
|
(18,400
|
)
|
(33,400
|
)
|
|||
Increase
in accounts payable and accrued expenses
|
326,200
|
804,313
|
|||||
Increase
in accrued interest - notes payable
|
119,014
|
302,466
|
|||||
Increase
in due to related party
|
78,280
|
84,109
|
|||||
|
|||||||
Net
cash used in operating activities
|
(1,756,597
|
)
|
(3,685,364
|
)
|
|||
|
|||||||
Cash
flows from investing activities
|
|||||||
Purchase
of property and equipment
|
(47,585
|
)
|
(64,448
|
)
|
|||
Investment
in notes receivable - employee
|
(46,676
|
)
|
(46,676
|
)
|
|||
Cash
paid for intangible assets
|
(6,183
|
)
|
(43,318
|
)
|
|||
|
|||||||
Net
cash used in investing activities
|
(100,444
|
)
|
(154,442
|
)
|
|||
|
|||||||
Cash
flows from financing activities
|
|||||||
Proceeds
from sale of common stock
|
-
|
5,000
|
|||||
Proceeds
from sale of convertible notes payable
|
-
|
4,000,000
|
|||||
|
|||||||
Net
cash provided by financing activities
|
-
|
4,005,000
|
|||||
|
|||||||
Net
(decrease) increase in cash and cash equivalents
|
(1,857,041
|
)
|
165,194
|
||||
|
|||||||
Cash
and cash equivalents, beginning of period
|
2,022,235
|
-
|
|||||
|
|||||||
Cash
and cash equivalents, end of period
|
$
|
165,194
|
$
|
165,194
|
2 |
Significant
accounting
policies
|
3 |
License
agreement
|
4 |
Note
receivable -
employee
|
5 |
Convertible
notes
payable
|
6 |
Stockholder's
equity
|
7 |
Stock
based
compensation
|
Risk-free
interest rate
|
4.70
%
|
Volatility
|
62.67
%
|
Estimated
life in years
|
4
years
|
Dividends
paid
|
None
|
Options
|
Shares
|
Weighted-Average
Exercise
Price
|
|||||
2006
and prior
|
|
|
|||||
|
|
|
|||||
Options
granted
|
75,000
|
$
|