As
filed with the Securities and Exchange Commission on April
3,
2006
|
Registration
No. 333-129680
|
Delaware
|
2834
|
84-1475642
|
(State
or other jurisdiction of
|
(Primary
Standard Industrial
Classification
Code Number)
|
(I.R.S.
Employer
|
Incorporation
or organization)
|
Identification
No.)
|
|
1180
Avenue of the Americas, 19th
Floor
New
York, NY 10036
(646)
214-0700
|
||
(Address
and telephone number off principal executive offices and principal
place
of business)
|
Dr.
Jonathan Lewis
Chief
Executive Officer
ZIOPHARM
Oncology, Inc.
1180
Avenue of the Americas, 19th Floor
New
York, NY 10036
Telephone:
(646) 214-0700
Facsimile:
(646) 214-0711
(Name,
address and telephone number of agent for service)
|
Copies
to:
William
M. Mower, Esq.
Alan
M. Gilbert, Esq.
Maslon
Edelman Borman & Brand, LLP
90
South 7th Street, Suite 3300
Minneapolis,
Minnesota 55402
Telephone:
(612) 672-8200
Facsimile:
(612) 642-8381
|
PROSPECTUS
SUMMARY
|
|
3
|
|
RISK
FACTORS
|
|
6
|
|
NOTE
REGARDING FORWARD-LOOKING STATEMENTS
|
|
14
|
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
|
15
|
|
DESCRIPTION
OF BUSINESS
|
|
21
|
|
MANAGEMENT
|
|
30
|
|
EXECUTIVE
COMPENSATION
|
|
33
|
|
CHANGES
IN OUR CERTIFYING ACCOUNTANT
|
|
38
|
|
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
|
|
39
|
|
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS
|
|
40
|
|
MARKET
FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
|
|
42
|
|
USE
OF PROCEEDS
|
|
43
|
|
SELLING
STOCKHOLDERS
|
|
44
|
|
PLAN
OF DISTRIBUTION
|
|
55
|
|
DESCRIPTION
OF CAPITAL STOCK
|
|
57
|
|
DISCLOSURE
OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT
LIABILITIES
|
|
57
|
|
ABOUT
THIS PROSPECTUS
|
|
58
|
|
WHERE
YOU CAN FIND MORE INFORMATION
|
|
58
|
|
VALIDITY
OF COMMON STOCK
|
|
58
|
|
EXPERTS
|
58
|
||
FINANCIAL
STATEMENTS
|
F-1
|
· |
ZIO-101
is
an organic arsenic compound covered by issued U.S. patents and
applications internationally. A form of commercially available
inorganic
arsenic (arsenic trioxide (Trisenox®) or ATO) has been approved for the
treatment of acute promyelocytic leukemia (APL), a precancerous
condition,
and is on the compendia listing for the therapy of multiple myeloma
as
well as having been studied for the treatment of various other
cancers.
Nevertheless, ATO has been shown to be toxic to the heart and liver,
limiting its use as an anti-cancer agent. Inorganic arsenic has
also been
shown to cause cancer of the skin and lung in humans. The toxicity
of
arsenic generally is correlated to its accumulation in organs and
tissues.
To date, the Company’s preclinical and Phase I studies have demonstrated
that ZIO-101 (and organic arsenic in general) is considerably less
toxic
than inorganic arsenic, particularly with regard to heart toxicity.
In
vitro testing of ZIO-101 using the National Cancer Institute’s human
cancer cell panel detected activity against lung, colon, brain,
melanoma,
ovarian and kidney cancer. Moderate activity was detected against
breast
and prostate cancer. In addition to solid tumors, in vitro testing
in both
the National Cancer Institute’s cancer cell panel and in vivo testing in a
leukemia animal model demonstrated substantial activity against
hematological cancers (cancers of the blood and blood-forming tissues)
such as leukemia, lymphoma, myelodysplastic syndromes and multiple
myeloma.
|
· |
ZIO-201,
or isophosphoramide mustard (IPM), is a proprietary stabilized
metabolite
of ifosfamide that is also related to cyclophosphamide. A patent
application for pharmaceutical composition has been filed.
Cyclophosphamide and ifosfamide are alkylating agents. The Company
believes cyclophosphamide is the most widely used alkylating agent
in
cancer therapy and is used to treat breast cancer and non-Hodgkin’s
lymphoma. Ifosfamide has been shown to be effective in high dose
by
itself, or in combination in treating sarcoma and lymphoma. Although
ifosfamide-based treatment generally represents the standard of
care for
sarcoma, it is not licensed for this indication by the FDA. Our
preclinical studies have shown that, in animal and laboratory models,
IPM
evidences activity against leukemia and solid tumors. These studies
also
indicate that ZIO-201 has a better pharmacokinetic and safety profile
than
ifosfamide or cyclophosphamide, offering the possibility of safer
and more
efficacious therapy with ZIO-201. Ifosfamide is metabolized to
IPM. In
addition to IPM, another metabolite of ifosfamide is acrolein,
which is
toxic to the kidneys and bladder. The presence of acrolein can
mandate the
administration of a protective agent called mesna, which is inconvenient
and expensive. Chloroacetaldehyde is another metabolite of ifosfamide
and
is toxic to the central nervous system, causing “fuzzy brain” syndrome for
which there is currently no protective measure. Similar toxicity
concerns
pertain to high-dose cyclophosphamide, which is widely used in
bone marrow
and blood cell transplantation. Because ZIO-201 is independently
active—without acrolein or chloroacetaldehyde metabolites—the Company
believes that the administration of ZIO-201 may avoid many of the
toxicities of ifosfamide and cyclophosphamide without compromising
efficacy. In addition to anticipated lower toxicity, ZIO-201 (and
without
the coadministration of mesna) may have other advantages over ifosfamide
and cyclophosphamide. ZIO-201 likely cross-links DNA differently
than
ifosfamide or cyclophosphamide metabolites, resulting in a different
activity profile. Moreover, in some instances ZIO-201 appears to
show
activity in ifosfamide- and/or cyclophosphamide-resistant cancer
cells.
|
|
Common
stock offered
|
7,462,095
shares
|
|
|
|
|
Common
stock outstanding before the offering(1)
|
7,272,992
shares
|
|
|
|
|
Common
stock outstanding after the offering(2)
|
7,755,399
shares
|
|
|
|
|
Common
Stock OTC Bulletin Board symbol
|
ZIOP
|
(1)
|
Based
on the number of shares outstanding as of March 27, 2006, not including
1,576,980 shares issuable upon exercise of various warrants and
options to
purchase our common stock.
|
(2) |
Assumes
the issuance of all shares offered hereby that are issuable upon
exercise
of warrants.
|
·
|
Continue
to undertake preclinical development and clinical trials for product
candidates;
|
·
|
Scale
up the formulation and manufacturing of our product candidates;
|
·
|
Seek
regulatory approvals for product candidates;
|
·
|
Implement
additional internal systems and infrastructure; and
|
·
|
Hire
additional personnel.
|
·
|
Continuing
to undertake preclinical development and clinical
trials;
|
·
|
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; and
|
·
|
Diminish
any competitive advantages that we may otherwise enjoy.
|
·
|
Unforeseen
safety issues;
|
·
|
Determination
of dosing issues;
|
·
|
Lack
of effectiveness during clinical trials;
|
·
|
Slower
than expected rates of patient recruitment;
|
·
|
Inability
to monitor patients adequately during or after treatment; and
|
·
|
Inability
or unwillingness of medical investigators to follow our clinical
protocols.
|
·
|
Perceptions
by members of the health care community, including physicians,
regarding
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 the
FDA must
approve any replacement contractor. This approval would require
new
testing and compliance inspections. In addition, a new manufacturer
would
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
needs
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 Administration (the “DEA”), and
corresponding state agencies to ensure strict compliance with good
manufacturing practices and other government regulations and corresponding
foreign standards. We do not have control over third-party manufacturers’
compliance with these regulations and standards.
|
·
|
If
any third-party manufacturer makes improvements in the manufacturing
process for our products, we may not own, or may have to share,
the
intellectual property rights to the innovation.
|
·
|
Developing
drugs;
|
·
|
Undertaking
preclinical 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;
|
·
|
Abandon
an infringing drug candidate;
|
·
|
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.
|
·
|
ZIO-101
is an organic arsenic compound covered by issued U.S. patents and
applications internationally. A form of commercially available
inorganic
arsenic (arsenic trioxide (Trisenox®) or ATO) has been approved for the
treatment of acute promyelocytic leukemia (APL), a precancerous
condition,
and is on the compendia listing for the therapy of multiple myeloma
as
well as having been studied for the treatment of various other
cancers.
Nevertheless, ATO has been shown to be toxic to the heart and liver,
limiting its use as an anti-cancer agent. Inorganic arsenic has
also been
shown to cause cancer of the skin and lung in humans. The toxicity
of
arsenic generally is correlated to its accumulation in organs and
tissues.
Our preclinical and phase I clinical studies to date have demonstrated
that ZIO-101 (and organic arsenic in general) is considerably less
toxic
than inorganic arsenic, particularly with regard to heart toxicity.
In
vitro testing of ZIO-101 using the National Cancer Institute’s human
cancer cell panel detected activity against lung, colon, brain,
melanoma,
ovarian and kidney cancer. Moderate activity was detected against
breast
and prostate cancer. In addition to solid tumors, in vitro testing
in both
the National Cancer Institute’s cancer cell panel and in vivo testing in a
leukemia animal model demonstrated substantial activity against
hematological cancers (cancers of the blood and blood-forming tissues)
such as leukemia, lymphoma, myelodysplastic syndromes and multiple
myeloma.
|
·
|
ZIO-201,
or isophosphoramide mustard (IPM), is a proprietary stabilized
metabolite
of ifosfamide that is also related to cyclophosphamide. A patent
application for pharmaceutical composition has been filed.
Cyclophosphamide and ifosfamide are alkylating agents. The Company
believes cyclophosphamide is the most widely used alkylating agent
in
cancer therapy and is used to treat breast cancer and non-Hodgkin’s
lymphoma. Ifosfamide has been shown to be effective in high dose
by
itself, or in combination in treating sarcoma and lymphoma. Although
ifosfamide-based treatment generally represents the standard of
care for
sarcoma, it is not licensed for this indication by the FDA. Our
preclinical studies have shown that, in animal and laboratory models,
IPM
evidences activity against leukemia and solid tumors. These studies
also
indicate that ZIO-201 has a better pharmacokinetic and safety profile
than
ifosfamide or cyclophosphamide, offering the possibility of safer
and more
efficacious therapy with ZIO-201. Ifosfamide is metabolized to
IPM. In
addition to IPM, another metabolite of ifosfamide is acrolein,
which is
toxic to the kidneys and bladder. The presence of acrolein can
mandate the
administration of a protective agent called mesna, which is inconvenient
and expensive. Chloroacetaldehyde is another metabolite of ifosfamide
and
is toxic to the central nervous system, causing “fuzzy brain” syndrome for
which there is currently no protective measure. Similar toxicity
concerns
pertain to high-dose cyclophosphamide, which is widely used in
bone marrow
and blood cell transplantation. Because ZIO-201 is independently
active—without acrolein or chloroacetaldehyde metabolites—we believe that
the administration of ZIO-201 may avoid many of the toxicities
of
ifosfamide and cyclophosphamide without compromising efficacy.
In addition
to anticipated lower toxicity, ZIO-201 (and without the co-administration
of mesna) may have other advantages over ifosfamide. In preclinical
studies ZIO-201 likely cross-links DNA differently than ifosfamide
or
cyclophosphamide metabolites, resulting in a different activity
profile.
Moreover, in some instances ZIO-201 appears to show activity in
ifosfamide- and/or cyclophosphamide-resistant cancer
cells.
|
· |
Fees
and milestone payments required under the license agreements relating
to
our existing product candidates and additional in-licensed candidates;
|
· |
Clinical
trial expenses, including the costs incurred with respect to the
conduct
of clinical trials for ZIO-101 and ZIO-201 and preclinical costs
associated with back-up candidates ZIO-102 and ZIO-202;
|
· |
Costs
related to the scale-up and manufacture of ZIO-101 and
ZIO-201;
|
· |
Rent
for our facilities; and
|
· |
General
corporate and working capital, including general and administrative
expenses.
|
· |
changes
in the focus and direction of our research and development
programs;
|
· |
competitive
and technical advances;
|
· |
costs
of commercializing any of product
candidates;
|
· |
costs
of filing, prosecuting, defending and enforcing any patent claims
and any
other intellectual property rights;
|
· |
or
other developments.
|
Payments
due by Period
|
||||||||||||||||
Total
|
Less
than 1 Year
|
1
-
3 Years
|
4
-
5 Years
|
After
5 Years
|
||||||||||||
Operating
lease
|
$
|
846,151
|
$
|
189,776
|
$
|
398,038
|
$
|
258,337
|
$
|
—
|
·
|
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
|
Jonathan
Lewis, M.D., Ph.D.
|
|
47
|
|
Director
& Chief Executive Officer
|
Richard
Bagley
|
|
62
|
|
Director,
President, Chief Operating Officer & Treasurer
|
Robert
Peter Gale, M.D., Ph.D, DSc.
|
|
60
|
|
Senior
Vice President Research
|
Murray
Brennan, M.D.
|
|
66
|
|
Director
|
James
Cannon
|
|
67
|
|
Director
|
Senator
Wyche Fowler, Jr., JD
|
|
65
|
|
Director
|
Gary
S. Fragin
|
|
59
|
|
Director
|
Timothy
McInerney
|
|
45
|
|
Director
|
Michael
Weiser, M.D., Ph.D.
|
|
43
|
|
Director
|
|
|
|
|
|
|
|
|
|
Annual
Compensation
|
|
|
Long-Term
Compensation
Awards
|
|
|||
Name
and Principal Position
|
|
|
Year
|
|
|
Salary
($)
|
|
|
Bonus
($)
|
|
|
Other
Annual
Compensation
($)
|
|
|
Securities
Underlying
Options
(#)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr.
Jonathan Lewis,
|
2005
|
|
|
350,000
|
|
|
250,000
|
(2)
|
|
5,657
|
|
|
141,950
|
|
||
Chief
Executive Officer (1)
|
|
|
2004
|
|
|
344,167
|
|
|
500,000
|
(3)
|
|
9,099
|
|
|
268,653
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Richard
E. Bagley,
|
|
|
2005
|
|
|
250,000
|
|
|
50,000
|
(5)
|
|
660
|
|
|
90,614
|
|
President,
Chief Operating
Officer
and Treasurer
(4)
|
|
|
2004
|
|
|
43,750
|
|
|
75,000
|
(6)
|
|
4,057
|
|
|
150,668
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr.
Robert Peter Gale,
|
|
|
2005
|
|
|
250,000
|
|
|
150,000
|
(8)
|
660
|
|
|
25,048
|
|
|
Senior
Vice President Research (7)
|
|
|
2004
|
|
|
239,583
|
|
|
150,000
|
(9)
|
|
2,543
|
|
|
25,110
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
David
C. Olson
Former
Chief Executive
Officer
(10)
|
|
|
2005
2004
2003
|
|
|
57,500
0
0
|
|
|
—
—
—
|
|
|
—
—
—
|
|
|
—
—
—
|
|
(1)
|
Dr.
Lewis became Chief Executive Officer effective upon the Company’s
September 13, 2005 merger with ZIOPHARM, Inc. Prior to the merger,
Dr.
Lewis served as Chief Executive Officer of ZIOPHARM, Inc. since
January 8,
2004. All compensation reported for fiscal year 2004 represents
amounts
received from ZIOPHARM, Inc. Compensation reported for fiscal year
2005
represents amounts received from ZIOPHARM, Inc. prior to the September
13,
2005 merger and amounts received from the Company from and after
the
merger.
|
(2)
|
Includes
a guaranteed bonus of $250,000 for work performed in fiscal 2005
that was
paid on January 15, 2006.
|
(3)
|
Includes
a signing bonus of $250,000 paid on February 23, 2004 and a guaranteed
bonus of $250,000 for work performed in fiscal 2004 that was paid
on April
22, 2005.
|
(4)
|
Mr.
Bagley became President, Chief Operating Officer and Treasurer
effective
upon the Company’s September 13, 2005 merger with ZIOPHARM, Inc. Prior to
the merger, Mr. Bagley served President and Chief Operating Officer
of
ZIOPHARM, Inc. since July 2004 and as Treasurer of ZIOPHARM, Inc.
since
March 2005. All compensation reported for fiscal year 2004 represents
amounts received from ZIOPHARM, Inc. Compensation reported for
fiscal year
2005 represents amounts received from ZIOPHARM, Inc. prior to the
September 13, 2005 merger and amounts received from the Company
from and
after the merger.
|
(5)
|
Includes
a year-end bonus of $25,000 received by Mr. Bagley on December
30, 2005;
also includes $25,000, a portion of his 2005 guaranteed bonus,
that Mr.
Bagley was accrued as of December 31, 2005 but which is not payable
until
July 31, 2006.
|
(6)
|
Includes
a signing bonus of $50,000 received by Mr. Bagley on July 30, 2004,
and
$25,000, a portion of his 2004 guaranteed bonus, that was accrued
as of
December 31, 2004 but was paid in July 15,
2005.
|
(7)
|
Dr.
Gale became Senior Vice President Research effective upon the Company’s
September 13, 2005 merger with ZIOPHARM, Inc. Prior to the merger,
Dr.
Gale served as Sr. Vice President Research of ZIOPHARM, Inc. since
January
15, 2004. All compensation reported for fiscal year 2004 represents
amounts received from ZIOPHARM, Inc. Compensation reported for
fiscal year
2005 represents amounts received from ZIOPHARM, Inc. prior to the
September 13, 2005 merger and amounts received from the Company
from and
after the merger.
|
(8)
|
Includes
a guaranteed bonus of $150,000 for work performed in fiscal 2005
that was
paid on January 31, 2006.
|
(9)
|
Includes
a guaranteed bonus of $150,000 for work performed in fiscal 2004
that was
paid on April 16, 2005.
|
(10)
|
Mr.
Olson resigned as an executive officer effective upon the Company’s
September 13, 2005 merger with ZIOPHARM, Inc. Upon closing of the
merger,
the Company paid Mr. Olson a one-time fee of $57,500 pursuant to
his
December 9, 2004 employment agreement. Mr. Olson received no other
cash
compensation from the Company for services rendered in his capacity
as an
executive officer during fiscal years 2003, 2004 and 2005.
|
Name
|
|
|
Number
of
Securities
Underlying
Options
Granted
(#)
|
|
|
Percent
of
Total
Options
Granted
to
Employees
In
Fiscal
Year
|
|
|
Exercise
or
Base
Price
($/share)
|
|
|
Expiration
Date(s)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr.
Jonathan Lewis (1)
|
|
|
87,789
|
|
|
19.8
|
%
|
$
|
4.31
|
|
|
6/8/15
|
Dr.
Jonathan Lewis (1)
|
|
|
54,161
|
|
|
12.2
|
%
|
$
|
4.31
|
|
|
9/13/15
|
Richard
E. Bagley (2)
|
|
|
63,197
|
|
|
14.23
|
%
|
$
|
4.31
|
|
|
6/8/15
|
Richard
E. Bagley (2)
|
|
|
27,417
|
|
|
6.17
|
%
|
$
|
4.31
|
|
|
9/13/15
|
Dr.
Robert Peter Gale
|
|
|
25,048
|
|
|
5.6
|
%
|
$
|
4.31
|
|
|
6/8/15
|
David
C. Olson
|
|
|
0
|
|
|
0
|
%
|
|
—
|
|
|
—
|
(1) |
Options
were granted pursuant to an anti-dilution provision pursuant to
which Dr.
Lewis was entitled to purchase no less than 5% of the Company’s common
stock until such time as the Company has raised $25 million in
financing.
Dr.
Lewis has waived his rights to receive further option grants pursuant
to
such anti-dilution
provision.
|
(2) |
Options
were granted pursuant to an anti-dilution provision pursuant to
which Mr.
Bagley was entitled to purchase no less than 3% of the Company’s common
stock until such time as the Company has raised $25 million in
financing.
Mr.
Bagley has waived his rights to receive further option grants pursuant
to
such anti-dilution
provision.
|
|
|
|
|
|
|
|
|
|
Number
of Unexercised
Securities
Underlying
Options
at FY-End (#)
|
|
|
Value
of Unexercised
In-the-Money
Options at FY-End ($)(1)
|
|
||||||
Name
|
|
|
Shares
Acquired
on Exercise (#)
|
|
|
Value
Realized
($)
|
|
|
Exercisable
|
|
|
Unexercisable
|
|
|
Exercisable
|
|
|
Unexercisable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr.
Jonathan Lewis
|
|
|
0
|
|
|
0
|
|
|
136,868
|
|
|
273,735
|
|
$
|
283,892
|
|
$
|
567,783
|
|
Richard
Bagley
|
|
|
0
|
|
|
0
|
|
|
80,427
|
|
|
160,855
|
|
$
|
78,011
|
|
$
|
156,022
|
|
Dr.
Robert Peter Gale
|
|
|
0
|
|
|
0
|
|
|
8,370
|
|
|
41,879
|
|
$
|
23,528
|
|
$
|
47,056
|
|
David
C. Olson
|
|
|
0
|
|
|
0
|
|
|
0
|
|
|
0
|
|
|
—
|
|
|
—
|
|
(1) |
Based
on the difference between the option exercise price and the closing
sale
price of the Company’s common stock on December 30, 2005 (the last trading
day prior to the end of the Company’s 2005 fiscal year), which was
$3.25.
|
Name
and Address of Beneficial Owner
|
|
Shares
of
Common
Stock
Beneficially
Owned
(#)(1)
|
|
Percentage
of
Common
Stock
Beneficially
Owned
(%)
|
|
||
|
|
|
|
|
|
|
|
Dr.
Jonathan Lewis
|
|
|
273,736
|
(2)
|
|
3.63
|
%
|
Richard
E. Bagley
|
|
|
80,428
|
(3)
|
|
1.09
|
%
|
Robert
Peter Gale
|
|
|
16,741
|
(4)
|
|
*
|
|
Murray
Brennan
|
|
|
7,515
|
(5)
|
|
*
|
|
James
Cannon
|
|
|
7,515
|
(5)
|
|
*
|
|
Hon.
Wyche Fowler
|
|
|
7,515
|
(5)
|
|
*
|
|
Gary
S. Fragin
|
|
|
7,515
|
(5)
|
|
*
|
|
Timothy
McInerney
|
|
|
79,972
|
(6)
|
|
1.10
|
%
|
Michael
Weiser
|
|
|
126,526
|
(7)
|
|
1.73
|
%
|
All
current executive officers and directors
|
|
|
607,463
|
(8)
|
|
7.85
|
%
|
as
a group
|
|
|
|
|
|
|
|
Mibars,
LLC (9)
365
West End Avenue
New
York, NY 10024
|
|
|
1,214,456
|
|
|
16.70
|
%
|
Lindsay
A. Rosenwald
|
|
|
|
|
|
|
|
787
Seventh Avenue, 48th Floor
|
|
|
|
|
|
|
|
New
York, NY 10019
|
|
|
1,323,606
|
(10)
|
|
17.52
|
%
|
Atlas
Equity I, Ltd.
181
W. Madison, Suite 3600
Chicago,
IL 60602
|
|
|
695,797
|
|
|
9.57
|
%
|
Lester
E. Lipschutz
|
|
|
|
|
|
|
|
1650
Arch Street, 22nd Floor
|
|
|
|
|
|
|
|
Philadelphia,
PA 19103
|
|
|
463,864
|
(11)
|
|
6.38
|
%
|
David
C. Olson (10)
|
|
|
|
|
|
|
|
6025
South Quebec Street, Suite 135
|
|
|
|
|
|
|
|
Englewood,
CO 80111
|
|
|
26,480
|
(12)
|
|
*
|
|
(1) |
Beneficial
ownership is determined in accordance with SEC rules, beneficial
ownership
includes any shares as to which the security or stockholder has
sole or
shared voting power or investment power, and also any shares which
the
security or stockholder has the right to acquire within 60 days
of the
date hereof, whether through the exercise or conversion of any
stock
option, convertible security, warrant or other right. The indication
herein that shares are beneficially owned is not an admission on
the part
of the security or stockholder that he, she or it is a direct or
indirect
beneficial owner of those
shares.
|
(2) |
Includes
273,736 shares issuable upon the exercise of stock options that
are
currently exercisable or will become exercisable within the next
60
days.
|
(3) |
Includes
80,428 shares issuable upon the exercise of stock options that are
currently exercisable or will become exercisable within the next
60
days.
|
(4) |
Includes
16,741 shares issuable upon the exercise of stock options that
are
currently exercisable or will become exercisable within the next
60
days.
|
(5) |
Includes
7,515 shares issuable upon the exercise of stock options that are
currently exercisable or will become exercisable within the next
60
days.
|
(6) |
Includes
20,767 shares issuable upon the exercise of warrants that are currently
exercisable or will become exercisable within the next 60
days.
|
(7) |
Includes
35,566 shares issuable upon the exercise of warrants and 7,515
shares
issuable upon the exercise of stock options that are currently
exercisable
or will become exercisable within the next 60
days.
|
(8) |
Includes
464,813 shares issuable upon the exercise of convertible securities
that
are currently exercisable or will become exercisable within the
next 60
days.
|
(9) |
Based
on the most recent Form 3 filed with the Securities and Exchange
Commission on September 23, 2005. Mibars, Inc. is a wholly-owned
subsidiary of Paloma International L.P.; S. Donald Sussman, the
controlling person of Paloma International L.P., may be deemed
to
beneficially own the shares of common stock beneficially owned
by Paloma
International L.P.
|
(10) |
Excludes
463,864 shares held by certain trusts for the benefit of Dr. Rosenwald
and
his family for which Dr. Rosenwald disclaims beneficial ownership.
Includes 221,011 shares issuable upon the exercise of warrants
granted to
Dr. Rosenwald and 62,621 shares issuable upon the exercise of warrants
granted to Paramount BioCapital Investments, LLC, of which Dr.
Rosenwald
is the managing member, both such warrants are currently exercisable
or
will become exercisable within the next 60 days. Also includes
563,296
shares that Dr. Rosenwald has the right to acquire from existing
stockholders under certain circumstances pursuant to the terms
of pledge
agreements between Dr. Rosenwald and such
stockholders.
|
(11) |
Includes
463,864 shares held by separate trusts for the benefit of Dr. Rosenwald
or
his family with respect to which Mr. Lipschutz is either trustee
or
investment manager and has investment and voting power. Dr. Rosenwald
disclaims beneficial ownership of these
shares.
|
(12) |
Mr.
Olson served as the Company’s Chief Executive Officer for the full fiscal
years indicated until the consummation of the Merger. Share amounts
include 50 shares held by Associate Capital Consulting, Inc. and
17,314
shares held by Summit Financial Relations, Inc., each of which
is
wholly-owned by Mr. Olson.
|
|
|
Price
Range
|
|
||||
Fiscal
Year 2005 (Quarter Ended)
|
|
High
|
|
Low
|
|
||
December
31, 2005
|
$
|
6.00
|
$
|
3.25
|
|||
September
30, 2005
|
|
$
|
0.40
|
|
$
|
0.00
|
|
June
30, 2005
|
|
$
|
0.05
|
|
$
|
0.00
|
|
March
31, 2005
|
|
$
|
0.05
|
|
$
|
0.00
|
|
|
|
|
|
|
|
|
|
Fiscal
Year 2004 (Quarter Ended)
|
|
High
|
|
Low
|
|
||
December
31, 2004
|
|
$
|
0.00
|
|
$
|
0.00
|
|
September
30, 2004
|
|
$
|
0.00
|
|
$
|
0.00
|
|
June
30, 2004
|
|
$
|
0.00
|
|
$
|
0.00
|
|
March
31, 2004
|
|
$
|
0.00
|
|
$
|
0.00
|
|
Plan
category
|
|
Number
of Securities
to
be Issued
Upon
Exercise of
Outstanding
Options
(A)
|
|
Weighted-
Average
Exercise
Price of
Outstanding
Options
(B)
|
|
Number
of
Securities
Remaining
Available
for
Future
Issuance
Under
Equity
Compensation
Plans
(Excluding
Securities
Reflected
in Column (A)
|
|
|||
|
|
|
|
|
|
|
|
|||
Equity
compensation plans approved by security holders:
|
|
|
|
|
|
|
|
|||
2003
Stock Option Plan
|
|
|
973,639
|
|
$
|
2.56
|
|
|
278,796
|
|
Total:
|
|
|
973,639
|
|
$
|
2.56
|
|
|
278,796
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity
compensation plans not approved by stockholders:
|
|
|
|
|
|
|
|
|
|
|
None
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Selling
Stockholder
|
Shares
Beneficially
Owned
Before
Offering
(1)
|
Number
of
Outstanding
Shares
Offered
by Selling
Stockholder
|
Number
of Shares
Offered
by Selling
Stockholder
upon
Exercise
of
Certain
Warrants
|
Percentage
Beneficial
Ownership
After
Offering
(2)
|
||||||
Robert
Guercio
|
7,515
|
7,515
|
0
|
—
|
||||||
Ennio
DePianto
|
6,012
|
6,012
|
0
|
—
|
||||||
Millennium
Partners, L.P.
|
231,932
|
231,932
|
0
|
—
|
||||||
Michael
A. Mullen
|
5,010
|
5,010
|
0
|
—
|
||||||
Philip
J. Abdalla and Joyce V. Abdalla JTWROS
|
6,012
|
6,012
|
0
|
—
|
||||||
Frank
Calcutta
|
12,524
|
12,524
|
0
|
—
|
||||||
The
Henry H. Bahr QTIP Trust Dated 2/22/88
|
11,597
|
11,597
|
0
|
—
|
||||||
The
Bahr Family Limited Partnership
|
11,597
|
11,597
|
0
|
—
|
||||||
Robert
L. Bahr Revocable Trust 1985 U/A dated 3-14-85
|
3,826
|
3,826
|
0
|
—
|
||||||
Stephen
C. Rabbitt
|
10,019
|
10,019
|
0
|
—
|
||||||
Delaware
Charter Guarantee Trust FBO
Richard
S. Simms II Keogh Plan
|
3,479
|
3,479
|
0
|
—
|
||||||
Lind
Family Investments LP
|
8,117
|
8,117
|
0
|
—
|
||||||
John
and Debbra Landsberger Family Trust
|
12,524
|
12,524
|
0
|
—
|
||||||
Balanced
Investment, LLC
|
46,386
|
46,386
|
0
|
—
|
||||||
Riverside
Contracting LLC
|
12,524
|
12,524
|
0
|
—
|
||||||
Walter
B. Martin and Paloma Munoz JTWROS
|
5,798
|
5,798
|
0
|
—
|
||||||
MSB
Family Trust DTD 6/25/93
Michael
Blechman, TTEE
|
23,194
|
23,194
|
0
|
—
|
||||||
Richard
S. Simms II and Cynthia Simms JTWROS
|
3,479
|
3,479
|
0
|
—
|
Selling
Stockholder
|
Shares
Beneficially
Owned
Before
Offering
(1)
|
Number
of
Outstanding
Shares
Offered
by Selling
Stockholder
|
Number
of Shares
Offered
by Selling
Stockholder
upon
Exercise
of
Certain
Warrants
|
Percentage
Beneficial
Ownership
After
Offering
(2)
|
||||||
Lawrence
M. Silver
|
17,000
|
17,000
|
0
|
—
|
||||||
Rick
J. Goad
|
10,019
|
10,019
|
0
|
—
|
||||||
Barry
Lind Revocable Trust
|
46,386
|
46,386
|
0
|
—
|
||||||
Stephen
N. Kitchens and Martha M. Kitchens JTWROS
|
23,194
|
23,194
|
0
|
—
|
||||||
Wayne
K. Adams
|
8,000
|
8,000
|
0
|
—
|
||||||
Jerrold
Abrahams
|
6,958
|
6,958
|
0
|
—
|
||||||
Shoup
Revocable Trust DTD April 29, 2003
|
11,598
|
11,598
|
0
|
—
|
||||||
Shea
Ventures, LLC
|
23,193
|
23,193
|
0
|
—
|
||||||
National
Investors Services Corp.
FBO
Stephen J. Nelson
|
23,194
|
23,194
|
0
|
—
|
||||||
James
C. Shepler and Diana B. Shepler JTWROS
|
6,958
|
6,958
|
0
|
—
|
||||||
Steven
Lisi
|
14,027
|
14,027
|
0
|
—
|
||||||
Phil
Lifshitz
|
23,195
|
23,195
|
0
|
—
|
||||||
Louis
Sanzo, Jr.
|
5,010
|
5,010
|
0
|
—
|
||||||
Barry
P. McIntosh
|
5,798
|
5,798
|
0
|
—
|
||||||
Hill
Blalock, Jr.
|
23,195
|
23,195
|
0
|
—
|
||||||
Joel
Braun
|
5,798
|
5,798
|
0
|
—
|
||||||
Far
Ventures
|
10,019
|
10,019
|
0
|
—
|
||||||
Brino
Investment Ltd.
|
5,798
|
5,798
|
0
|
—
|
||||||
OZF
Investments LLC
|
115,966
|
115,966
|
0
|
—
|
||||||
Tisu
Investment Ltd.
|
17,395
|
17,395
|
0
|
—
|
||||||
Edmund
A. Debler
|
17,033
|
17,033
|
0
|
—
|
||||||
Daniel
Krieger
|
5,798
|
5,798
|
0
|
—
|
||||||
Andrew
W. Albstein and Carolyn Albstein JTWROS
|
23,194
|
23,194
|
0
|
—
|
||||||
Elizabeth
R. Moore
|
5,798
|
5,798
|
0
|
—
|
||||||
Ursuline
Co.
|
12,524
|
12,524
|
0
|
—
|
||||||
Carl
S. Sorenson
|
11,597
|
11,597
|
0
|
—
|
||||||
Carucci
Family Partners
|
34,790
|
34,790
|
0
|
—
|
||||||
Anthony
J. Ottavio
|
12,524
|
12,524
|
0
|
—
|
||||||
Daniel
J. Kevles and Betty Ann Kevles JTWROS
|
8,117
|
8,117
|
0
|
—
|
||||||
Gavin
Kent
|
5,798
|
5,798
|
0
|
—
|
Selling
Stockholder
|
Shares
Beneficially
Owned
Before
Offering
(1)
|
Number
of
Outstanding
Shares
Offered
by Selling
Stockholder
|
Number
of Shares
Offered
by Selling
Stockholder
upon
Exercise
of
Certain
Warrants
|
Percentage
Beneficial
Ownership
After
Offering
(2)
|
Michael
Luftman
|
5,798
|
5,798
|
0
|
—
|
||||||
Anthony
J. Gerace
|
11,598
|
11,598
|
0
|
—
|
||||||
Isaac
R. Dweck
|
23,193
|
23,193
|
0
|
—
|
||||||
Fae
Moore
|
5,798
|
5,798
|
0
|
—
|
||||||
Ben
Heller
|
61,000
|
61,000
|
0
|
—
|
||||||
Elizabeth
Maas
|
5,798
|
5,798
|
0
|
—
|
||||||
Robert
Masters
|
11,597
|
11,597
|
0
|
—
|
||||||
Klaus
Kretschmer
|
46,591
|
46,591
|
0
|
—
|
||||||
Dean
Glasser
|
3,757
|
3,757
|
0
|
—
|
||||||
Murry
J. McCabe
|
34,790
|
34,790
|
0
|
—
|
||||||
Cooper
A. McIntosh, MD
|
11,597
|
11,597
|
0
|
—
|
||||||
Harry
Newton and Susan Newton JTWROS
|
17,534
|
17,534
|
0
|
—
|
||||||
Nicholas
Ponzio
|
24,048
|
24,048
|
0
|
—
|
||||||
Gary
J. Strauss
|
23,194
|
23,194
|
0
|
—
|
||||||
Scott
D. Whitaker
|
11,597
|
11,597
|
0
|
—
|
||||||
Wolcot
Capital, Inc.
|
24,048
|
24,048
|
0
|
—
|
||||||
Joseph
J. Vale
|
115,966
|
115,966
|
0
|
—
|
||||||
Carolyn
N. Taylor
|
3,507
|
3,507
|
0
|
—
|
||||||
David
P. Luci
|
2,319
|
2,319
|
0
|
—
|
||||||
Atlas
Equity I, Ltd.
|
695,797
|
695,797
|
0
|
—
|
||||||
Alan
H. Auerbach
|
5,798
|
5,798
|
0
|
—
|
||||||
Gregory
J. Dovolis
|
10,019
|
10,019
|
0
|
—
|
||||||
Michele
Markowitz
|
5,798
|
5,798
|
0
|
—
|
||||||
Praful
Desai
|
5,010
|
5,010
|
0
|
—
|
||||||
Eric
Reed
|
5,010
|
5,010
|
0
|
—
|
||||||
Delaware
Charter Guarantee Trust FBO Mark Berg IRA
|
57,612
|
57,612
|
0
|
—
|
||||||
Nicole
Berg
|
57,612
|
57,612
|
0
|
—
|
||||||
Ivy
Scheinholz Revocable Trust U/A Dated 1/26/05
|
5,010
|
5,010
|
0
|
—
|
||||||
S.
Alan Lisenby
|
25,049
|
25,049
|
0
|
—
|
||||||
Judah
Schorr
|
34,790
|
34,790
|
0
|
—
|
||||||
Mark
Mazzer
|
6,262
|
6,262
|
0
|
—
|
||||||
Domaco
Venture Capital Fund
|
5,799
|
5,799
|
0
|
—
|
Selling
Stockholder
|
Shares
Beneficially
Owned
Before
Offering
(1)
|
Number
of
Outstanding
Shares
Offered
by Selling
Stockholder
|
Number
of Shares
Offered
by Selling
Stockholder
upon
Exercise
of
Certain
Warrants
|
Percentage
Beneficial
Ownership
After
Offering
(2)
|
Fiserv
Securities, Inc. A/C/F Jack Polar IRA
|
5,799
|
5,799
|
0
|
—
|
||||||
Paul
D. Newman and Judith E. Newman JTWROS
|
6,012
|
6,012
|
0
|
—
|
||||||
Neil
J. Laird
|
6,012
|
6,012
|
0
|
—
|
||||||
Rachel
Family Partnership
|
34,790
|
34,790
|
0
|
—
|
||||||
Baruch
Z. Halberstam
|
5,798
|
5,798
|
0
|
—
|
||||||
Paul
J. Solit
|
5,798
|
5,798
|
0
|
—
|
||||||
Lucile
Slocum
|
10,019
|
10,019
|
0
|
—
|
||||||
Harvey
Lustig and Ronnie Lustig JTWROS
|
5,010
|
5,010
|
0
|
—
|
||||||
Stephen
H. Lebovitz
|
1,002
|
1,002
|
0
|
—
|
||||||
Joe
L. Key and Mary Lynn Key JTWROS
|
1,002
|
1,002
|
0
|
—
|
||||||
Delaware
Charter Guarantee & Trust Co.
FBO
Howard M. Tanning MD IRA
|
25,049
|
25,049
|
0
|
—
|
||||||
Gitel
Family Partnership, LP
|
23,193
|
23,193
|
0
|
—
|
||||||
Joseph
Strassman and Barbara Strassman
|
6,958
|
6,958
|
0
|
—
|
||||||
David
G. Pudelsky and Nancy H. Pudelsky JTWROS
|
10,019
|
10,019
|
0
|
—
|
||||||
Louis
R. Reif
|
22,544
|
22,544
|
0
|
—
|
||||||
John
O. Dunkin
|
6,012
|
6,012
|
0
|
—
|
||||||
Michael
Pinney
|
2,505
|
2,505
|
0
|
—
|
||||||
Neel
B. Ackerman and Martha N. Ackerman JTWROS
|
25,049
|
25,049
|
0
|
—
|
||||||
Fiserv
Securities, Inc. A/C/F Ronald M. Lazar, STD IRA
|
5,799
|
5,799
|
0
|
—
|
||||||
RL
Capital Partners, LP
|
11,598
|
11,598
|
0
|
—
|
||||||
Neil
Herskowitz
|
6,262
|
6,262
|
0
|
—
|
||||||
Anthony
G. Polak “S”
|
5,799
|
5,799
|
0
|
—
|
||||||
Fiserv
Securities, Inc. A/C/F Anthony G. Polak Std. IRA
|
5,799
|
5,799
|
0
|
—
|
||||||
Tim
P. Cooper
|
4,634
|
4,634
|
0
|
—
|
||||||
Benito
Bucay
|
11,597
|
11,597
|
0
|
—
|
Selling
Stockholder
|
Shares
Beneficially
Owned
Before
Offering
(1)
|
Number
of
Outstanding
Shares
Offered
by Selling
Stockholder
|
Number
of Shares
Offered
by Selling
Stockholder
upon
Exercise
of
Certain
Warrants
|
Percentage
Beneficial
Ownership
After
Offering
(2)
|
Edwin
A. Buckham and Wendy F. Buckham, JTWROS
|
11,597
|
11,597
|
0
|
—
|
||||||
Laya
Perlysky 2003 Grantor Retained Annuity Trust
|
23,193
|
23,193
|
0
|
—
|
||||||
Kinder
Investments L.P.
|
34,790
|
34,790
|
0
|
—
|
||||||
Reuben
Taub
|
12,524
|
12,524
|
0
|
—
|
||||||
Waterspout
Investments Pte Ltd
|
4,639
|
4,639
|
0
|
—
|
||||||
Matador
Investments Pte Ltd.
|
16,235
|
16,235
|
0
|
—
|
||||||
Ramsay
Investments Pte. Ltd.
|
2,319
|
2,319
|
0
|
—
|
||||||
Mega
International Corporation
|
8,581
|
8,581
|
0
|
—
|
||||||
Alfred
Abraham
|
4,639
|
4,639
|
0
|
—
|
||||||
Paul
Sallwasser and Teri Sallwasser JTWROS
|
17,395
|
17,395
|
0
|
—
|
||||||
William
S. Tyrell
|
4,000
|
4,000
|
0
|
—
|
||||||
Alan
J. Young
|
26,000
|
26,000
|
0
|
—
|
||||||
William
McCahey and Lisa Krivacka JTWROS
|
5,799
|
5,799
|
0
|
—
|
||||||
Dennis
F. Steadman
|
5,799
|
5,799
|
0
|
—
|
||||||
John
H. Miller, CGM IRA Custodian Smith Barney #670-80424-18
|
6,262
|
6,262
|
0
|
—
|
||||||
Paul
Bermanski and Barbara Bermanski JTWROS
|
11,597
|
11,597
|
0
|
—
|
||||||
Tokenhouse
Trading Pte. Ltd.
|
46,386
|
46,386
|
0
|
—
|
||||||
James
E. Daly, CGM IRA Custodian #670-80477
|
6,262
|
6,262
|
0
|
—
|
||||||
Howard
Sorkin
|
23,193
|
23,193
|
0
|
—
|
||||||
Janis
H. Camp
|
5,798
|
5,798
|
0
|
—
|
||||||
Robert
McEntire
|
46,387
|
46,387
|
0
|
—
|
||||||
Andrew
H. Sabreen and Carol Sabreen JTWROS
|
11,597
|
11,597
|
0
|
—
|
||||||
Michael
Blechman and Barry J. Lind, Tenants in Common
|
11,597
|
11,597
|
0
|
—
|
||||||
Paul
F. Berlin
|
5,798
|
5,798
|
0
|
—
|
||||||
Eli
Jaconson
|
23,194
|
23,194
|
0
|
—
|
||||||
Andrew
W. Schonzeit
|
12,524
|
12,524
|
0
|
—
|
||||||
Nora
O’Donoghue
|
5,798
|
5,798
|
0
|
—
|
||||||
Mario
Pasquel and Begona Miranda JTWROS
|
16,235
|
16,235
|
0
|
—
|
Selling
Stockholder
|
Shares
Beneficially
Owned
Before
Offering
(1)
|
Number
of
Outstanding
Shares
Offered
by Selling
Stockholder
|
Number
of Shares
Offered
by Selling
Stockholder
upon
Exercise
of
Certain
Warrants
|
Percentage
Beneficial
Ownership
After
Offering
(2)
|
Suzanne
Schiller
|
5,010
|
5,010
|
0
|
—
|
||||||
William
S. Silver and Elinor Silver JTWROS
|
6,012
|
6,012
|
0
|
—
|
||||||
Suzette
T. Seigel
|
5,798
|
5,798
|
0
|
—
|
||||||
Robert
J. Sechan II
|
5,798
|
5,798
|
0
|
—
|
||||||
Coqui
Capital Partners
|
57,984
|
57,984
|
0
|
—
|
||||||
Carolyn
P. Dietrich
|
6,007
|
6,007
|
0
|
—
|
||||||
Smithfield
Fiduciary LLC
|
231,932
|
231,932
|
0
|
—
|
||||||
Michael
S. Walsh
|
5,798
|
5,798
|
0
|
—
|
||||||
Keith
Rubenstein
|
5,798
|
5,798
|
0
|
—
|
||||||
Dr.
Jeffrey R. Shapiro
|
5,798
|
5,798
|
0
|
—
|
||||||
Bernard
Wachsman
|
5,798
|
5,798
|
0
|
—
|
||||||
Concordia
Partners L.P.
|
175,341
|
175,341
|
0
|
—
|
||||||
The
Lindsay A. Rosenwald 2000
Irrevocable
Trust U/A dated 5/24/2000
|
231,932
|
231,932
|
0
|
—
|
||||||
The
Lindsay Rosenwald 2000 Family Trust U/A dated 12/15/00
|
231,932
|
231,932
|
0
|
—
|
||||||
Mark
J. Ahn
|
5,798
|
5,798
|
0
|
—
|
||||||
Jeffrey
Kraws & Patricia Kraws
|
5,798
|
5,798
|
0
|
—
|
||||||
Jack
B. Petersen
|
5,798
|
5,798
|
0
|
—
|
||||||
Charles
Earl Cartmill
|
11,597
|
11,597
|
0
|
—
|
||||||
Robert
J. Whetten
|
11,597
|
11,597
|
0
|
—
|
||||||
Paramount
BioCapital, Inc.
|
62,621
|
0
|
62,621
|
—
|
||||||
Steven
Markowitz
|
6,480
|
0
|
6,480
|
—
|
||||||
Fabio
Migliaccio
|
2,504
|
0
|
2,504
|
—
|
||||||
Denise
Mormile-Liglino
|
1,252
|
0
|
1,252
|
—
|
||||||
Michael
Mullen
|
13,534
|
0
|
13,534
|
—
|
||||||
Robert
Petrozzo
|
11,083
|
0
|
11,083
|
—
|
||||||
Joseph
Sorbara
|
6,480
|
0
|
6,480
|
—
|
||||||
Robert
D. Millstone
|
3,479
|
0
|
3,479
|
—
|
||||||
Steven
A. Sherman
|
1,739
|
0
|
1,739
|
—
|
||||||
Sandgrain
Securities, Inc.
|
579
|
0
|
579
|
—
|
||||||
Lindsay
A. Rosenwald
|
1,323,606(3)
|
476,678
|
221,011
|
8.35%
|
Selling
Stockholder
|
Shares
Beneficially
Owned
Before
Offering
(1)
|
Number
of
Outstanding
Shares
Offered
by Selling
Stockholder
|
Number
of Shares
Offered
by Selling
Stockholder
upon
Exercise
of
Certain
Warrants
|
Percentage
Beneficial
Ownership
After
Offering
(2)
|
Michael
Weiser
|
126,526
|
83,445
|
35,566
|
*
|
||||||
Harris
Lydon
|
22,349
|
0
|
22,349
|
—
|
||||||
Timothy
McInerney
|
79,972
|
59,205
|
20,767
|
*
|
||||||
Michael
Rosenman
|
31,854
|
0
|
19,709
|
*
|
||||||
Scott
Katzman
|
28,817
|
0
|
19,709
|
*
|
||||||
Jill
Meleski
|
19,674
|
0
|
16,638
|
*
|
||||||
Bernard
Gross
|
10,285
|
0
|
8,767
|
*
|
||||||
Karl
Ruggeberg
|
9,368
|
0
|
7,850
|
*
|
||||||
Jeana
Somers
|
1,808
|
0
|
290
|
*
|
||||||
Everest
Capital (f/k/a Four Brothers
Investment
Holding)
|
12,524
|
12,524
|
0
|
—
|
||||||
Future
Global Holding, Inc.
|
626
|
626
|
0
|
—
|
||||||
Valeo
Partners, LLC
|
6,262
|
6,262
|
0
|
—
|
||||||
The
Holding Company
|
4,384
|
4,384
|
0
|
—
|
||||||
Melvyn
I. Weiss
|
12,524
|
12,524
|
0
|
—
|
||||||
Issac
M. Dabah
|
10,019
|
10,019
|
0
|
—
|
||||||
Lillian
Hahn
|
3,131
|
3,131
|
0
|
—
|
||||||
Donna
Kash & Peter Kash JT TEN
|
5,010
|
5,010
|
0
|
—
|
||||||
Pearl
Capital LP (f/k/a Weisenberg Real Estate LP)
|
1,252
|
1,252
|
0
|
—
|
||||||
David
J. Bershad
|
3,131
|
3,131
|
0
|
—
|
||||||
NTP
Partners
|
3,131
|
3,131
|
0
|
—
|
||||||
Aaron
Speisman
|
1,566
|
1,566
|
0
|
—
|
||||||
Joseph
Friedman Trust
|
1,252
|
1,252
|
0
|
—
|
||||||
Robert
Falk
|
1,252
|
1,252
|
0
|
—
|
||||||
335
MAD LLC (f/k/a/ Beck Technologies LLC)
|
3,757
|
3,757
|
0
|
—
|
||||||
Yitzhak
Nissan
|
1,252
|
1,252
|
0
|
—
|
||||||
Alan
Clingman
|
1,252
|
1,252
|
0
|
—
|
||||||
Benjamin
Feinswog Trust
|
3,757
|
3,757
|
0
|
—
|
||||||
Henry
and Monica Millin
|
1,252
|
1,252
|
0
|
—
|
||||||
Robert
Klein
|
1,252
|
1,252
|
0
|
—
|
||||||
Kanter
Family Foundation
|
1,879
|
1,879
|
0
|
—
|
||||||
The
University of Texas M.D. Anderson
|
250,487
|
250,487
|
0
|
—
|
||||||
Lawrence
Alpert
|
500
|
500
|
0
|
*
|
Selling
Stockholder
|
Shares
Beneficially
Owned
Before
Offering
(1)
|
Number
of
Outstanding
Shares
Offered
by Selling
Stockholder
|
Number
of Shares
Offered
by Selling
Stockholder
upon
Exercise
of
Certain
Warrants
|
Percentage
Beneficial
Ownership
After
Offering
(2)
|
Associate
Capital Consulting Inc.
|
50
|
50
|
0
|
*
|
||||||
Vicki
D E Barone
|
25
|
25
|
0
|
*
|
||||||
Edward
W Bellarose
|
100
|
100
|
0
|
*
|
||||||
Black
Marlen Inc
|
100
|
100
|
0
|
*
|
||||||
Craig
M Blake
|
50
|
50
|
0
|
*
|
||||||
Darrell
J Brunken
|
25
|
25
|
0
|
*
|
||||||
Scot
Bryant
|
100
|
100
|
0
|
*
|
||||||
Charles
Schwab & Co. Inc.
|
100
|
100
|
0
|
*
|
||||||
John
Cleaver & Karen Cleaver JTTEN
|
100
|
100
|
0
|
*
|
||||||
William
D. Cronin
|
100
|
100
|
0
|
*
|
||||||
Michael
M Edmonds
|
100
|
100
|
0
|
*
|
||||||
Doyle
S Elliott
|
25
|
25
|
0
|
*
|
||||||
Tyler
Floor
|
3,750
|
3,750
|
0
|
*
|
||||||
William
R Going
|
25
|
25
|
0
|
*
|
||||||
B
Kathleen Goldstone
|
25
|
25
|
0
|
*
|
||||||
Allen
R Goldstone
|
25
|
25
|
0
|
*
|
||||||
Timothy
S Greufe
|
150
|
150
|
0
|
*
|
||||||
C.
Eugene Gronning
|
1,250
|
1,250
|
0
|
*
|
||||||
Michael
Gundzik
|
100
|
100
|
0
|
*
|
||||||
Johanna
Guttman & Robert Herskowitz JTEN
|
10,750
|
10,750
|
0
|
*
|
||||||
Mark
Hatsis
|
1,500
|
1,500
|
0
|
*
|
||||||
Anderson
J Henshaw
|
100
|
100
|
0
|
*
|
||||||
Brad
Henshaw
|
100
|
100
|
0
|
*
|
||||||
Brent
Henshaw
|
13,709
|
13,709
|
0
|
*
|
||||||
Brent
Henshaw
|
250
|
250
|
0
|
*
|
||||||
Robert
Herskowitz
|
4,000
|
4,000
|
0
|
*
|
||||||
Al
Hoff
|
100
|
100
|
0
|
*
|
||||||
James
E Hosch
|
100
|
100
|
0
|
*
|
||||||
Joseph
W. Hovorka
|
1,667
|
1,667
|
0
|
*
|
||||||
Reed
Jensen
|
1,250
|
1,250
|
0
|
*
|
||||||
Key
Investments
|
2,500
|
2,500
|
0
|
*
|
Selling
Stockholder
|
Shares
Beneficially
Owned
Before
Offering
(1)
|
Number
of
Outstanding
Shares
Offered
by Selling
Stockholder
|
Number
of Shares
Offered
by Selling
Stockholder
upon
Exercise
of
Certain
Warrants
|
Percentage
Beneficial
Ownership
After
Offering
(2)
|
Bryant
Kligerman
|
100
|
100
|
0
|
*
|
||||||
Harvey
Levin
|
25
|
25
|
0
|
*
|
||||||
VLA
LLP
|
50
|
50
|
0
|
*
|
||||||
Curtis
M McQueen
|
50
|
50
|
0
|
*
|
||||||
Mathew
Meister c/o Beeman Holdings
|
25
|
25
|
0
|
*
|
||||||
Gary
Mendenhall
|
25
|
25
|
0
|
*
|
||||||
Jeffrey
Myers
|
25
|
25
|
0
|
*
|
||||||
Jeffrey
Myers
|
1,667
|
1,667
|
0
|
*
|
||||||
Morri
L Namaste
|
100
|
100
|
0
|
*
|
||||||
National
Financial Services LLC
|
25
|
25
|
0
|
*
|
||||||
NF
Clearing Inc.
|
75
|
75
|
0
|
*
|
||||||
Robert
E Ohman
|
25
|
25
|
0
|
*
|
||||||
David
C. Olson
|
9,116
|
9,116
|
0
|
*
|
||||||
Thomas
B. Olson
|
5,000
|
5,000
|
0
|
*
|
||||||
Butternut
Partners
|
5,000
|
5,000
|
0
|
*
|
||||||
Jeff
Peterson
|
1,250
|
1,250
|
0
|
*
|
||||||
Barbara
Petrinsky
|
442
|
442
|
0
|
*
|
||||||
Merrill
Lynch Pierce Fenner & Smith Inc.
|
25
|
25
|
0
|
*
|
||||||
Brad
Rhodes
|
200
|
200
|
0
|
*
|
||||||
Jeff
Rodriguez
|
25
|
25
|
0
|
*
|
||||||
Lamar
F Schild
|
500
|
500
|
0
|
*
|
||||||
Sanford
Schwartz
|
25
|
25
|
0
|
*
|
||||||
Susan
Schwartz
|
25
|
25
|
0
|
*
|
||||||
Scott
Shovea
|
50
|
50
|
0
|
*
|
||||||
Don
F. Sims
|
50
|
50
|
0
|
*
|
||||||
Carlene
Smith
|
25
|
25
|
0
|
*
|
||||||
Michael
J Stallone
|
200
|
200
|
0
|
*
|
||||||
Summit
Financial Relations Inc.
|
17,314
|
17,314
|
0
|
*
|
||||||
James
H Swalwell & Judith A Swalwell JTTEN
|
50
|
50
|
0
|
*
|
||||||
Thomas
M. Vickers
|
5,000
|
5,000
|
0
|
*
|
||||||
James
J Trainor
|
125
|
125
|
0
|
*
|
Selling
Stockholder
|
Shares
Beneficially
Owned
Before
Offering
(1)
|
Number
of
Outstanding
Shares
Offered
by Selling
Stockholder
|
Number
of Shares
Offered
by Selling
Stockholder
upon
Exercise
of
Certain
Warrants
|
Percentage
Beneficial
Ownership
After
Offering
(2)
|
Thomas
M. Vickers Revocable Trust
|
5,000
|
5,000
|
0
|
*
|
||||||
Thomas
M. Vickers
|
250
|
250
|
0
|
*
|
||||||
Douglas
A Wilkerson & Leola A Wilkerson JTTEN
|
25
|
25
|
0
|
*
|
||||||
Lyn
C Wilkerson
|
30
|
30
|
0
|
*
|
||||||
Derek
J. Zappa
|
100
|
100
|
0
|
*
|
||||||
Robert
J. Zappa
|
24,000
|
24,000
|
0
|
*
|
||||||
Albert
J. Zirkelbach
|
50
|
50
|
0
|
*
|
||||||
Jason
Stein
|
83,445
|
83,445
|
0
|
—
|
||||||
Jeffrey
Serbin
|
91,036
|
91,036
|
0
|
—
|
||||||
Stephen
Rocamboli
|
40,677
|
40,677
|
0
|
—
|
||||||
Jay
Lobell
|
59,156
|
59,156
|
0
|
—
|
||||||
Jillian
Hoffman
|
7,590
|
7,590
|
0
|
—
|
||||||
William
Corcoran
|
12,145
|
12,145
|
0
|
—
|
||||||
Kyle
Kuhn
|
6,072
|
6,072
|
0
|
—
|
||||||
David
Butera
|
60,723
|
60,723
|
0
|
—
|
||||||
Peter
Barber
|
3,036
|
3,036
|
0
|
—
|
||||||
Anil
Chenthitta
|
3,036
|
3,036
|
0
|
—
|
||||||
Matthew
Wyckoff
|
3,036
|
3,036
|
0
|
—
|
||||||
David
Nussbaum
|
3,036
|
3,036
|
0
|
—
|
||||||
Michael
Rosenman
|
31,854
|
12,145
|
0
|
*
|
||||||
John
Knox
|
9,108
|
9,108
|
0
|
—
|
||||||
Jennifer
McNealy
|
5,465
|
5,465
|
0
|
—
|
||||||
John
Cipriano
|
5,465
|
5,465
|
0
|
—
|
||||||
Elena
Ridloff
|
5,465
|
5,465
|
0
|
—
|
||||||
Louis
Smookler
|
12,145
|
12,145
|
0
|
—
|
||||||
Donna
Lozito
|
6,072
|
6,072
|
0
|
—
|
||||||
Scott
Katzmann
|
28,817
|
9,108
|
0
|
*
|
||||||
John
Papadimitropoulos
|
3,036
|
3,036
|
0
|
—
|
||||||
Basil
Christakos
|
6,072
|
6,072
|
0
|
—
|
||||||
Eric
Lee
|
3,036
|
3,036
|
0
|
—
|
||||||
Timothy
Shands
|
3,036
|
3,036
|
0
|
—
|
||||||
Claudia
Donat
|
3,036
|
3,036
|
0
|
—
|
||||||
John
Best
|
1,822
|
1,822
|
0
|
—
|
||||||
Elbert
Chu
|
1,822
|
1,822
|
0
|
—
|
Selling
Stockholder
|
Shares
Beneficially
Owned
Before
Offering
(1)
|
Number
of
Outstanding
Shares
Offered
by Selling
Stockholder
|
Number
of Shares
Offered
by Selling
Stockholder
upon
Exercise
of
Certain
Warrants
|
Percentage
Beneficial
Ownership
After
Offering
(2)
|
Allison
Robbins
|
1,518
|
1,518
|
0
|
—
|
||||||
Jamie
Cabibihan
|
1,768
|
1,768
|
0
|
—
|
||||||
Bernard
Gross
|
10,285
|
1,518
|
0
|
*
|
||||||
Peter
Kash
|
83,445
|
83,445
|
0
|
—
|
||||||
David
Tanen
|
12,145
|
12,145
|
0
|
—
|
||||||
Jill
Meleski
|
19,674
|
3,036
|
0
|
*
|
||||||
Aaron
Rollins
|
3,036
|
3,036
|
0
|
—
|
||||||
Delores
Ferraro
|
1,518
|
1,518
|
0
|
—
|
||||||
Kristen
Plonisch
|
1,518
|
1,518
|
0
|
—
|
||||||
Marion
Birch
|
1,518
|
1,518
|
0
|
—
|
||||||
Nicole
Netolicky
|
1,518
|
1,518
|
0
|
—
|
||||||
Elizabeth
Marrero
|
1,518
|
1,518
|
0
|
—
|
||||||
Gabriel
Pilaloa
|
1,518
|
1,518
|
0
|
—
|
||||||
Demitrios
Marras
|
1,518
|
1,518
|
0
|
—
|
||||||
Kathleen
Fogerty
|
1,518
|
1,518
|
0
|
—
|
||||||
Danielle
Flatly
|
1,518
|
1,518
|
0
|
—
|
||||||
Jeana
Sommers
|
1,808
|
1,518
|
0
|
—
|
||||||
Karl
Ruggeberg
|
9,368
|
1,518
|
0
|
*
|
||||||
Mibars,
LLC
|
1,214,456
|
1,214,456
|
0
|
—
|
||||||
Joshua
Kazam and Joia Kazam JTWROS
|
12,145
|
12,145
|
0
|
—
|
||||||
Mark
O. Thornton
|
8,370
|
8,370
|
0
|
—
|
||||||
Chase
Financing, Inc.
|
83,348
|
83,348
|
0
|
—
|
||||||
Total
|
|
6,979,688
|
482,407
|
(1) |
Beneficial
ownership is determined in accordance with SEC rules, beneficial
ownership
includes any shares as to which the security or stockholder
has sole or
shared voting power or investment power, and also any shares
which the
security or stockholder has the right to acquire within 60
days of the
date hereof, whether through the exercise or conversion of
any stock
option, convertible security, warrant or other right. The indication
herein that shares are beneficially owned is not an admission
on the part
of the security or stockholder that he, she or it is a direct
or indirect
beneficial owner of those
shares.
|
(2) |
Assumes
sales of all shares by the selling
stockholder.
|
(3) |
In
addition to 476,678 shares of common stock and 221,011 shares
issuable
upon the exercise of warrants being
offered hereunder, this amount includes 62,621
shares issuable upon the exercise of warrants granted to Paramount
BioCapital
Investments, LLC, of which Dr. Rosenwald is the managing member,
and
563,296 shares that Dr.
Rosenwald has the right to acquire from existing stockholders
under
certain circumstances pursuant to the
terms of pledge agreements between Dr. Rosenwald and such stockholders.
Excludes 463,864 shares held
by certain trusts for the benefit of Dr. Rosenwald and his family
for
which Dr. Rosenwald disclaims beneficial
ownership.
|
·
|
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;
|
·
|
short
sales;
|
·
|
through
the writing or settlement of options or other hedging transactions,
whether through an options exchange or
otherwise;
|
·
|
broker-dealers
may agree with the selling stockholder to sell a specified number
of such
shares at a stipulated price per
share;
|
·
|
a
combination of any such methods of sale;
and
|
·
|
any
other method permitted pursuant to applicable
law.
|
|
|
Page
|
Audited
Financial Statements of ZIOPHARM Oncology, Inc.:
|
|
|
Report
of Independent Registered Accounting Firm
|
|
F-1
|
Balance
Sheets as at December 31, 2005 and December 31, 2004
|
|
F-2
|
Statements
of Operations for the Years Ended December 31, 2005 and 2004, For
the
Period from Inception (September 9, 2003) through December 31,
2003, and
For the Period from Inception (September 9, 2003) through December
31,
2005
|
|
F-3
|
Statements
of Cash Flows for the Years Ended December 31, 2005 and 2004, For
the
Period from Inception (September 9, 2003) through December 31,
2003, and
For the Period from Inception (September 9, 2003) through December
31,
2005
|
|
F-4
|
Statement
of Changes in Convertible Preferred Stock and Stockholders’
Equity/(Deficit) for the Years Ended December 31, 2005 and 2004,
For the
Period from Inception (September 9, 2003) through December 31,
2003, and
For the Period from Inception (September 9, 2003) through December
31,
2005
|
|
F-6
|
Notes
to Consolidated Financial Statements
|
|
F-7
|
|
|
|
ZIOPHARM
Oncology, Inc.
|
|||||||
(A
Development Stage Enterprise)
|
|||||||
Balance
Sheets
|
|||||||
|
|
|
|||||
|
December
31, 2005
|
December
31, 2004
|
|||||
ASSETS
|
|
|
|||||
Current
assets:
|
|
|
|||||
Cash
and cash equivalents
|
$
|
8,880,717
|
$
|
1,026,656
|
|||
Prepaid
expenses and other current assets
|
211,837
|
117,571
|
|||||
Total
current assets
|
9,092,554
|
1,144,227
|
|||||
|
|||||||
Property
and equipment, net
|
269,702
|
240,733
|
|||||
|
|||||||
Deposits
|
5,700
|
60,046
|
|||||
Other
non current assets
|
124,343
|
–
|
|||||
|
|||||||
Total
assets
|
$
|
9,492,299
|
$
|
1,445,006
|
|||
|
|||||||
|
|||||||
|
|||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
835,997
|
$
|
709,947
|
|||
Accrued
expenses
|
1,418,819
|
879,376
|
|||||
Total
current liabilities
|
2,254,816
|
1,589,323
|
|||||
Deferred
rent
|
35,557
|
–
|
|||||
Commitments
and contingencies (Note 6)
|
|||||||
|
|||||||
|
|||||||
Stockholders'
equity (deficit):
|
|||||||
Common
stock, $.001 par value; 280,000,000 shares
authorized;
|
|||||||
7,248,115
and 2,761,625 shares issued and outstanding
|
|||||||
at December
31, 2005 and 2004, respectively
|
7,248
|
2,761
|
|||||
Additional
paid-in capital
|
22,559,034
|
5,700,355
|
|||||
Deficit
accumulated during the development stage
|
(15,364,356
|
)
|
(5,847,433
|
)
|
|||
Total
stockholders' equity (deficit)
|
7,201,926
|
(144,317
|
)
|
||||
|
|||||||
Total
liabilities and stockholders' equity (deficit)
|
$
|
9,492,299
|
$
|
1,445,006
|
ZIOPHARM
Oncology, Inc.
|
|||||||||||||
(A
Development Stage Enterprise)
|
|||||||||||||
Statements
of Operations
|
|||||||||||||
For
the years ended December 31, 2005 and 2004,
for
the period from inception (September 9, 2003) through
December
31, 2003, and for the period from inception
(September
9, 2003) through December 31, 2005
|
|||||||||||||
|
|
|
For
the Period
|
For
the Period
|
|||||||||
|
|
|
from
Inception
|
from
Inception
|
|||||||||
For
the
|
For
the
|
(September
9,
|
(September
9,
|
||||||||||
|
Year
|
Year
|
2003)
|
2003)
|
|||||||||
|
Ended
|
Ended
|
through
|
through
|
|||||||||
|
December
31,
2005
|
December
31,
2004
|
December
31,
2003
|
December
31,
2005
|
|||||||||
|
|
|
|
|
|||||||||
Revenue
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
|||||
|
|||||||||||||
Operating
expenses and other income:
|
|||||||||||||
Research
and development, including
|
|||||||||||||
costs
of research contracts
|
5,593,850
|
2,126,607
|
-
|
7,720,457
|
|||||||||
General
and administrative
|
4,193,553
|
3,581,959
|
160,634
|
7,936,146
|
|||||||||
Total
operating expenses
|
9,787,403
|
5,708,566
|
160,634
|
15,656,603
|
|||||||||
|
|||||||||||||
Loss
from operations
|
(9,787,403
|
)
|
(5,708,566
|
)
|
(160,634
|
)
|
(15,656,603
|
)
|
|||||
|
|||||||||||||
Interest
income
|
270,479
|
21,269
|
498
|
292,247
|
|||||||||
Net
loss
|
$
|
(9,516,923
|
)
|
$
|
(5,687,297
|
)
|
$
|
(160,136
|
)
|
$
|
(15,364,356
|
)
|
|
|
|||||||||||||
|
|||||||||||||
Basic
and diluted net loss per share
|
$
|
(2.32
|
)
|
$
|
(2.37
|
)
|
$
|
(2.04
|
)
|
||||
|
|||||||||||||
Weighted
average common shares outstanding used to
|
|||||||||||||
compute
basic and diluted net loss per share
|
4,101,514
|
2,402,017
|
78,320
|
ZIOPHARM
Oncology, Inc.
|
|||||||||||||
(A
Development Stage Enterprise)
|
|||||||||||||
Statements
of Cash Flows
|
|||||||||||||
For
the Years Ended December 31, 2005 and 2004,
for
the period from inception (September 9, 2003)
through
December 31, 2003, and for the period from
inception
(September 9, 2003) through December 31, 2005
|
|||||||||||||
|
|
|
|
|
|||||||||
|
For
the
|
For
the
|
For
the Period
|
For
the Period
|
|||||||||
Twelve
|
Twelve
|
from
Inception
|
from
Inception
|
||||||||||
|
Months
|
Months
|
(September
9, 2003)
|
(September
9, 2003)
|
|||||||||
|
ended
|
ended
|
through
|
through
|
|||||||||
|
December
31, 2005
|
December
31, 2004
|
December
31, 2003
|
December
31, 2005
|
|||||||||
Cash
flows from operating activities:
|
|
|
|
|
|||||||||
Net
loss
|
$
|
(9,516,923
|
)
|
$
|
(5,687,297
|
)
|
$
|
(160,136
|
)
|
$
|
(15,364,356
|
)
|
|
Adjustments
to reconcile net loss to net cash
|
|||||||||||||
used
in operating activities:
|
|||||||||||||
Depreciation
and amortization
|
101,232
|
33,953
|
-
|
135,185
|
|||||||||
Stock-based
compensation
|
98,755
|
703,116
|
-
|
801,871
|
|||||||||
Change
in operating assets and liabilities:
|
|||||||||||||
(Increase)
decrease in:
|
|||||||||||||
Prepaid
expenses and other current assets
|
(94,266
|
)
|
(117,571
|
)
|
-
|
(211,837
|
)
|
||||||
Other
noncurrent assets
|
(124,343
|
)
|
-
|
-
|
(124,343
|
)
|
|||||||
Deposits
|
54,346
|
(60,046
|
)
|
-
|
(5,700
|
)
|
|||||||
Increase
in:
|
|||||||||||||
Accounts
payable
|
126,050
|
647,448
|
62,499
|
835,997
|
|||||||||
Accrued
expenses
|
539,443
|
879,376
|
-
|
1,418,819
|
|||||||||
Deferred
rent
|
35,557
|
-
|
-
|
35,557
|
|||||||||
Net
cash used in operating activities
|
(8,780,149
|
)
|
(3,601,021
|
)
|
(97,637
|
)
|
(12,478,807
|
)
|
|||||
|
|||||||||||||
Cash
flows from investing activities:
|
|||||||||||||
Purchases
of property and equipment
|
(130,201
|
)
|
(274,686
|
)
|
-
|
(404,887
|
)
|
||||||
Net
cash used in investing activities
|
(130,201
|
)
|
(274,686
|
)
|
-
|
(404,887
|
)
|
||||||
|
|||||||||||||
Cash
flows from financing activities:
|
|||||||||||||
Stockholders'
capital contribution
|
-
|
-
|
500,000
|
500,000
|
|||||||||
Proceeds
from issuance of common stock, net
|
4,815
|
4,500,000
|
-
|
4,504,815
|
|||||||||
Proceeds
from issuance of preferred stock, net
|
16,759,596
|
-
|
-
|
16,759,596
|
|||||||||
Net
cash provided by financing activities
|
16,764,411
|
4,500,000
|
500,000
|
21,764,411
|
|||||||||
|
|||||||||||||
Net
increase in cash and cash equivalents
|
7,854,061
|
624,293
|
402,363
|
8,880,717
|
|||||||||
|
|||||||||||||
Cash
and cash equivalents, beginning of period
|
1,026,656
|
402,363
|
-
|
-
|
|||||||||
|
|||||||||||||
Cash
and cash equivalents, end of period
|
$
|
8,880,717
|
$
|
1,026,656
|
$
|
402,363
|
$
|
8,880,717
|
ZIOPHARM
Oncology, Inc.
(A
Development Stage Enterprise)
Statements
of Cash Flows (continued)
For
the Years Ended December 31, 2005 and 2004,
for
the period from inception (September 9, 2003)
through
December 31, 2003, and for the period from
inception
(September 9, 2003) through December 31, 2005
|
|
For
the
|
For
the
|
For
the Period
|
For
the Period
|
||||||||||
Twelve
|
Twelve
|
from
Inception
|
from
Inception
|
||||||||||
Months
|
Months
|
(September
9, 2003)
|
(September
9, 2003)
|
||||||||||
ended
|
ended
|
through
|
through
|
||||||||||
December
31, 2005
|
December
31, 2004
|
December
31, 2003
|
December
31, 2005
|
||||||||||
Supplementary
disclosure of cash flow information:
|
|||||||||||||
Cash
paid for interest
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
|||||
|
|||||||||||||
Cash
paid for income taxes
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
|||||
Supplementary
disclosure of noncash investing and financing
activities:
|
|||||||||||||
Warrants
issued to placement agent, in connection with preferred stock
issuance
|
$
|
1,682,863
|
$
|
-
|
$
|
-
|
$
|
1,682,863
|
ZIOPHARM
Oncology, Inc.
|
||||||||||||||||||||||||||||
(A
Development Stage Enterprise)
|
||||||||||||||||||||||||||||
Statement
of Changes in Convertible Preferred Stock and Stockholders' Equity
(Deficit)
|
||||||||||||||||||||||||||||
For
the Years Ended December 31, 2005 and 2004,
for
the period from inception (September 9, 2003)
through
December 31, 2003, and for the period from
inception
(September 9, 2003) through December 31, 2005
|
Convertible
Preferred Stock and Warrants
|
Stockholder's
Equity (Deficit)
|
||||||||||||||||||||||||
Series
A
Convertible
Preferred
Stock
|
Warrants
to Purchase Series A
Convertible
Preferred
Stock
|
Common
Stock
|
Additional
Paid-in
|
Deficit
Accumulated
during
the
Development
|
Total
Stockholders'
Equity/
|
||||||||||||||||||||
Shares
|
Amount
|
Warrants
|
Shares
|
Amount
|
Capital
|
Stage
|
(Deficit)
|
||||||||||||||||||
Stockholders'
contribution, September 9, 2003
|
-
|
$
|
-
|
$
|
-
|
250,487
|
$
|
250
|
$
|
499,750
|
$
|
-
|
$
|
500,000
|
|||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
-
|
(160,136
|
)
|
(160,136
|
)
|
|||||||||||||||
Balance
at December 31, 2003
|
-
|
-
|
-
|
250,487
|
250
|
499,750
|
(160,136
|
)
|
339,864
|
||||||||||||||||
Issuance
of common stock
|
-
|
-
|
-
|
2,254,389
|
2,254
|
4,497,746
|
-
|
4,500,000
|
|||||||||||||||||
Issuance
of common stock for services
|
256,749
|
257
|
438,582
|
-
|
438,839
|
||||||||||||||||||||
Fair
value of options/warrants issued for nonemployee services
|
-
|
-
|
-
|
-
|
-
|
264,277
|
-
|
264,277
|
|||||||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
-
|
(5,687,297
|
)
|
(5,687,297
|
)
|
|||||||||||||||
|
|||||||||||||||||||||||||
Balance
at December 31, 2004
|
-
|
-
|
-
|
2,761,625
|
2,761
|
5,700,355
|
(5,847,433
|
)
|
(144,317
|
)
|
|||||||||||||||
|
|||||||||||||||||||||||||
Issuance
of Series A convertible preferred stock (net of expenses of $1,340,263
and
warrant costs of $1,682,863)
|
4,197,946
|
15,076,733
|
-
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||||
Fair
value of warrants to purchase Series A convertible preferred stock
|
-
|
-
|
1,682,863
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||||
Issuance
of Common stock to EasyWeb Shareholders
|
189,922
|
190
|
(190
|
)
|
-
|
-
|
|||||||||||||||||||
Conversion
of Series A convertible preferred stock @ $0.001 into $0.001 common
stock
on September 13, 2005 at an exchange ratio of .500974
|
(4,197,946
|
)
|
(15,076,733
|
)
|
(1,682,863
|
)
|
4,197,946
|
4,198
|
16,755,398
|
-
|
16,759,596
|
||||||||||||||
Issuance
of common stock due to exercise of stock options
|
-
|
-
|
-
|
98,622
|
99
|
4,716
|
-
|
4,815
|
|||||||||||||||||
Fair
value of options/warrants issued for nonemployee services
|
-
|
-
|
-
|
-
|
-
|
98,755
|
-
|
98,755
|
|||||||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
-
|
(9,516,923
|
)
|
(9,516,923
|
)
|
|||||||||||||||
|
|||||||||||||||||||||||||
Balance
at December 31, 2005
|
-
|
$
|
-
|
$
|
-
|
7,248,115
|
$
|
7,248
|
$
|
22,559,034
|
$
|
(15,364,356
|
)
|
$
|
7,201,926
|
1. | ORGANIZATION (continued) |
2.
|
SUMMARY
OF SIGNIFICANT ACCOUNTING
POLICIES
|
2.
|
SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES…continued
|
For
the year ended December 31,
|
For
the period
from
inception
(September
9, 2003)
to
December 31,
|
|||||||||
2005
|
2004
|
2003
|
||||||||
Net
loss:
|
||||||||||
As
reported
|
$
|
(9,516,923
|
)
|
$
|
(5,687,297
|
)
|
$
|
(160,136
|
)
|
|
Stock-based
compensation expense included in reported net loss
|
98,755
|
703,116
|
—
|
|||||||
Stock-based
compensation expense under the fair value-based method
|
(942,888
|
)
|
(813,095
|
)
|
—
|
|||||
Pro
forma net loss
|
$
|
(10,361,056
|
)
|
$
|
(5,797,276
|
)
|
$
|
(160,136
|
)
|
|
|
||||||||||
Basic
and diluted net loss per share:
|
||||||||||
As
reported
|
$
|
(2.32
|
)
|
$
|
(2.37
|
)
|
$
|
(2.04
|
)
|
|
Pro
forma
|
$
|
(2.53
|
)
|
$
|
(2.41
|
)
|
$
|
(2.04
|
)
|
2.
|
SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES…continued
|
|
2005
|
2004
|
2003
|
|||||||
Expected
life
|
5
years
|
5
years
|
—
|
|||||||
Expected
volatility
|
109%
- 114
|
%
|
134
|
%
|
—
|
|||||
Dividend
yield
|
0
|
%
|
0
|
%
|
—
|
|||||
Weighted
average risk-free interest rate
|
3.77
- 4.39
|
%
|
3.6
|
%
|
—
|
3.
|
PROPERTY
AND EQUIPMENT
|
|
Estimated
|
|
|
|||||||
|
Useful
Life
|
|
|
|||||||
|
(Years)
|
2005
|
2004
|
|||||||
|
|
|
|
|||||||
Software,
Office & Computer equipment
|
3
|
$
|
349,527
|
$
|
274,686
|
|||||
Leasehold
Improvements
|
3
|
43,004
|
—
|
|||||||
Manufacturing
Equipment
|
5
|
12,357
|
—
|
|||||||
|
|
404,888
|
274,686
|
|||||||
Less
- accumulated depreciation and amortization
|
|
135,186
|
33,953
|
|||||||
|
|
$
|
269,702
|
$
|
240,733
|
4.
|
ACCRUED
EXPENSES
|
|
2005
|
2004
|
|||||
|
|
|
|||||
Employee
compensation
|
$
|
441,668
|
$
|
506,391
|
|||
Professional
services
|
76,649
|
42,767
|
|||||
Research
and development consulting services
|
69,466
|
8,340
|
|||||
Clinical
consulting services
|
369,439
|
37,667
|
|||||
Manufacturing
services and manufacturing consulting services
|
388,563
|
212,211
|
|||||
Founders
fee
|
—
|
60,000
|
|||||
Accrued
vacation
|
6,765
|
—
|
|||||
Other
|
66,269
|
12,000
|
|||||
|
$
|
1,418,819
|
$
|
879,376
|
5.
|
RELATED
PARTY TRANSACTIONS
|
6.
|
COMMITMENTS
AND CONTINGENCIES
|
|
Operating
|
|||
|
Leases
|
|||
2006
|
$
|
189,776
|
||
2007
|
192,499
|
|||
2008
|
205,539
|
|||
2009
|
195,105
|
|||
2010
|
63,232
|
|||
|
|
|||
|
$
|
846,151
|
6.
|
COMMITMENTS
AND CONTINGENCIES...continued
|
6.
|
COMMITMENTS
AND CONTINGENCIES...continued
|
7.
|
INCOME
TAXES
|
|
December
31,
|
December
31,
|
|||||
|
2005
|
2004
|
|||||
Net
operating loss carryforwards
|
$
|
2,550,081
|
$
|
494,881
|
|||
Start-up
and organizational costs
|
3,392,774
|
1,502,217
|
|||||
Research
and development credit carryforwards
|
293,606
|
81,670
|
|||||
Accrued
bonus
|
16,779
|
200,343
|
|||||
Depreciation
|
14,419
|
(4,102
|
)
|
||||
Other
|
56,042
|
8,816
|
|||||
Net
deferred tax assets
|
6,323,701
|
2,283,825
|
|||||
Deferred
tax asset valuation allowance
|
(6,323,701
|
)
|
(2,283,825
|
)
|
|||
|
$ |
—
|
$
|
—
|
8.
|
CONVERTIBLE
PREFERRED STOCK AND STOCKHOLDERS’
EQUITY
|
8.
|
CONVERTIBLE
PREFERRED STOCK AND STOCKHOLDERS’ EQUITY...continued
|
9.
|
STOCK
OPTION PLAN
|
|
|
Weighted-
|
|||||
|
|
Average
|
|||||
|
Number
of
|
Exercise
|
|||||
|
Shares
|
Price
|
|||||
|
|
|
|||||
Outstanding,
January 1, 2004
|
1,250
|
$
|
20.00
|
||||
Granted
|
586,553
|
1.25
|
|||||
Exercised
|
—
|
—
|
|||||
Canceled
|
—
|
—
|
|||||
Outstanding,
December 31, 2004
|
587,803
|
$
|
1.29
|
||||
Granted
|
542,389
|
3.60
|
|||||
Exercised
|
(91,719
|
)
|
0.05
|
||||
Canceled
|
(64,834
|
)
|
3.29
|
||||
Outstanding,
December 31, 2005
|
973,639
|
$
|
2.56
|
||||
|
|||||||
Options
available for future grants
|
271,676
|
9.
|
STOCK
OPTION PLAN (continued)
|
|
Options
Outstanding
|
Options
Exercisable
|
||||||||||||||
Exercise
Price
|
Number
Outstanding
|
Weighted-
Average
Remaining
Contractual
Life
(Years)
|
Weighted-
Average
Exercise
Price
|
Number
Exercisable
|
Weighted-
Average
Exercise
Price
|
|||||||||||
|
|
|
|
|
|
|||||||||||
$0.08
|
268,654
|
8.07
|
$
|
0.08
|
89,551
|
$
|
.08
|
|||||||||
$0.44
|
25,111
|
8.07
|
$
|
0.44
|
8,370
|
$
|
.44
|
|||||||||
$1.70
|
176,750
|
8.52
|
$
|
1.70
|
58,917
|
$
|
1.70
|
|||||||||
$4.05
|
109,250
|
9.96
|
$
|
4.05
|
—
|
$
|
—
|
|||||||||
$4.31
|
392,624
|
9.41
|
$
|
4.31
|
115,345
|
$
|
4.31
|
|||||||||
$20.00
|
1,250
|
4.97
|
$
|
20.00
|
1,250
|
$
|
20.00
|
|||||||||
|
973,639
|
8.90
|
$
|
2.56
|
273,434
|
$
|
2.31
|
10.
|
WARRANTS
|
10.
|
WARRANTS
(continued)
|
Number
|
Issued
in connection with
|
Exercise
Price
|
Expiration
Date
|
|||||||
62,621
|
Services
performed
|
$
|
4.75
|
December
23, 2011
|
||||||
419,794
|
|
Placement
warrants for services performed
|
$
|
4.75
|
May
31, 2012
|
|||||
50,000
|
Services
performed
|
$
|
4.75
|
November
22, 2012
|
||||||
532,415
|
||||||||||
11.
|
Employee
Benefit Plan
|
SEC
registration fee
|
$
|
10,358.42
|
||
Legal
fees and expenses
|
20,690.82
|
|||
Accounting
fees and expenses
|
11,225.00
|
|||
Printing
and engraving expenses
|
5,849.00
|
|||
Miscellaneous
|
1,000.00
|
|||
$
|
49,123.24
|
Exhibit
No.
|
Description
of Document
|
2.1
|
Agreement
and Plan of Merger among the Registrant (formerly EasyWeb, Inc.),
ZIO
Acquisition Corp. and ZIOPHARM, Inc., dated August 3, 2005 (incorporated
by reference to Exhibit 10.1 to the Registrant’s Form 8-K filed August 9,
2005).
|
3.1
|
Certificate
of Incorporation of the Registrant (formerly EasyWeb. Inc.), as
filed with
the Delaware Secretary of State on May 16, 2005 (incorporated by
reference
to Exhibit 3.1 to the Registrant’s Registration Statement on Form SB-2
(SEC File No. 333-129020) filed October 14, 2005).
|
3.2
|
Certificate
of Merger dated September 13, 2005, relating to the merger of ZIO
Acquisition Corp. with and into ZIOPHARM, Inc. (incorporated by
reference
to Exhibit 3.1 to the Registrant’s Form 8-K filed September 19,
2005).
|
3.3
|
Certificate
of Ownership of the Registrant (formerly EasyWeb, Inc.) dated as
of
September 14, 2005, relating the merger of ZIOPHARM, Inc. with
and into
the Registrant and changing the Registrant’s corporate name from EasyWeb,
Inc. to ZIOPHARM Oncology, Inc. (incorporated by reference to Exhibit
3.2
to the Registrant’s Form 8-K filed September 19, 2005).
|
3.4
|
Bylaws,
as amended to date (incorporated by reference to Exhibit 3.3 to
the
Registrant’s Form 8-K filed September 19, 2005).
|
4.1
|
Specimen
common stock certificate. (incorporated by reference to Exhibit
4.1 to the
Registrant’s Registration Statement on Form SB-2 (SEC File No. 333-129020)
filed October 14, 2005).
|
4.2
|
Form
of Warrant issued to placement agents in connection with ZIOPHARM,
Inc.
2005 private placement (incorporated by reference to Exhibit 4.2
to the
Registrant’s Registration Statement on Form SB-2 (SEC File No. 333-129020)
filed October 14, 2005).
|
4.3
|
Schedule
identifying holders of Warrants in the form filed as Exhibit 4.2
to this
Report (incorporated by reference to Exhibit 4.3 to the Registrant’s
Registration Statement on Form SB-2 (SEC File No. 333-129020) filed
October 14, 2005).
|
4.4
|
Warrant
for the Purchase of Shares of Common Stock dated December 23, 2004.
(incorporated by reference to Exhibit 4.4 to the Registrant’s Registration
Statement on Form SB-2 (SEC File No. 333-129020) filed October
14,
2005).
|
4.5
|
Option
for the Purchase of Common Stock dated October 15, 2004 and issued
to
DEKK-Tec, Inc. (incorporated by reference to Exhibit 4.5 to the
Registrant’s Annual Report on Form 10-KSB filed (SEC File No. 000-32353)
March 20, 2006).
|
4.6
|
Form
of Option for the Purchase of Shares of Common Stock dated August
30, 2004
and issued to The University of Texas M.D. Anderson Cancer Center.
(incorporated by reference to Exhibit 4.6 to the Registrant’s Annual
Report on Form 10-KSB filed (SEC File No. 000-32353) March 20,
2006).
|
4.7
|
Schedule
identifying material terms of Options for the Purchase of Shares
of Common
Stock in the form filed as Exhibit 4.6 to this Report. (incorporated
by
reference to Exhibit 4.7 to the Registrant’s Annual Report on Form 10-KSB
filed (SEC File No. 000-32353) March 20, 2006).
|
5.1
|
Legal
opinion of Maslon Edelman Borman & Brand, LLP (incorporated by
reference to Exhibit 5.1 of the Registrant’s Registration Statement on
Form SB-2 (File 333-129020)).
|
5.2
|
Legal
opinion of Maslon Edelman Borman & Brand, LLP (incorporated by
reference to Exhibit 5.1 of the Registrant’s Registration Statement on
Form SB-2 (File 333-129680)).
|
10.3
|
Employment
Agreement dated January 15, 2004, between the Registrant and Dr.
Robert
Peter Gale (incorporated by reference to Exhibit 10.3 to the Registrant’s
Registration Statement on Form SB-2 (SEC File No. 333-129020) filed
October 14, 2005).
|
10.4
|
Employment
Agreement dated July 21, 2004, between the Registrant and Richard
Bagley
(incorporated by reference to Exhibit 10.4 to the Registrant’s
Registration Statement on Form SB-2 (SEC File No. 333-129020) filed
October 14, 2005).
|
10.5
|
Patent
and Technology License Agreement dated August 24, 2004, among ZIOPHARM,
Inc. (predecessor to the Registrant), the Board of Regents of the
University of Texas System on behalf of the University of Texas
M.D.
Anderson Cancer Center and the Texas A&M University System
(incorporated by reference to Exhibit 10.5 to the Registrant’s
Registration Statement on Form SB-2 (SEC File No. 333-129020) filed
October 14, 2005).++
|
10.6
|
License
Agreement dated October 15, 2004, between ZIOPHARM, Inc. (predecessor
to
the Registrant) and DEKK-Tec, Inc. (incorporated by reference to
Exhibit
10.6 to the Registrant’s Registration Statement on Form SB-2 (SEC File No.
333-129020) filed October 14,
2005).++
|
10.7
|
Form
of subscription agreement between the ZIOPHARM, Inc. and the investors
in
ZIOPHARM, Inc.’s private placement (incorporated by reference to Exhibit
10.7 to the Registrant’s Registration Statement on Form SB-2 (SEC File No.
333-129020) filed October 14, 2005).
|
10.8
|
Form
of Incentive Stock Option Agreement granted under 2003 Stock Option
Plan
(incorporated by reference to Exhibit 10.7 to the Registrant’s Annual
Report on Form 10-KSB (SEC File No. 000-32353) filed March 20,
2006).
|
10.9
|
Form
of Employee Non-Qualified Stock Option Agreement granted under
2003 Stock
Option Plan (incorporated by reference to Exhibit 10.8 to the Registrant’s
Annual Report on Form 10-KSB (SEC File No. 000-32353) filed March
20,
2006).
|
10.10
|
Form
of Director Non-Qualified Stock Option Agreement granted under
2003 Stock
Option Plan (incorporated by reference to Exhibit 10.9 to the Registrant’s
Annual Report on Form 10-KSB (SEC File No. 000-32353) filed March
20,
2006).
|
23.1
|
Consent
of Independent Registered Public Accounting Firm - Vitale, Caturano
&
Company, Ltd.
|
23.3
|
Consent
of Maslon Edelman Borman & Brand, LLP (included as part of Exhibit
5.1).
|
23.4
|
Consent
of Maslon Edelman Borman & Brand, LLP (included as part of Exhibit
5.2).
|
ZIOPHARM
Oncology, Inc.
|
||
|
|
|
By: |
/s/
Jonathan
Lewis
|
|
Jonathan
Lewis
|
||
Chief
Executive Officer
|
Signature
|
|
Title
|
|
Date
|
/s/
Jonathan Lewis
|
|
Director
and Chief Executive Officer
|
|
April
3, 2006
|
Jonathan
Lewis
|
|
(Principal
Executive Officer)
|
|
|
/s/
Richard E. Bagley
|
|
Director,
President, Treasurer and Chief
|
|
April
3, 2006
|
Richard
Bagley
|
|
Operating
Officer (Principal Accounting and Financial Officer)
|
|
|
*
|
|
Director
|
|
April
3, 2006
|
Murray
Brennan
|
|
|
|
|
*
|
|
Director
|
|
April
3, 2006
|
James
Cannon
|
|
|
|
|
*
|
|
Director
|
|
April
3, 2006
|
Timothy
McInerney
|
|
|
|
|
*
|
|
Director
|
|
April
3, 2006
|
Wyche
Fowler, Jr.
|
|
|
|
|
*
|
|
Director
|
|
April
3, 2006
|
Gary
S. Fragin
|
|
|
|
|
*
|
|
Director
|
|
April
3, 2006
|
Michael
Weiser
|
|
|
||
* By: /s/ Richard Bagley | ||||
Richard Bagley, Attorney-in-fact | ||||
Exhibit
No.
|
Description
of Document
|
23.1
|
Consent
of Independent Registered Public Accounting Firm - Vitale, Caturano
&
Company, Ltd.
|