Page
|
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PROSPECTUS
SUMMARY
|
1
|
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RISK
FACTORS
|
5
|
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NOTE
REGARDING FORWARD-LOOKING STATEMENTS
|
15
|
|||
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
|
16
|
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DESCRIPTION
OF BUSINESS
|
21
|
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MANAGEMENT
|
30
|
|||
EXECUTIVE
COMPENSATION
|
33
|
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CHANGES IN OUR CERTIFYING ACCOUNTANT | 37 | |||
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
|
38
|
|||
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS
|
40
|
|||
MARKET
FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
|
43
|
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USE
OF PROCEEDS
|
43
|
|||
SELLING
STOCKHOLDERS
|
44
|
|||
PLAN
OF DISTRIBUTION
|
45
|
|||
DESCRIPTION
OF CAPITAL STOCK
|
47
|
|||
DISCLOSURE
OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT
LIABILITIES
|
48
|
|||
ABOUT
THIS PROSPECTUS
|
48
|
|||
WHERE
YOU CAN FIND MORE INFORMATION
|
48
|
|||
VALIDITY
OF COMMON STOCK
|
49
|
|||
EXPERTS
|
49
|
· |
ZIO-101
is
an organic arsenic compound covered by an issued U.S. patent 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. The Company’s preclinical studies
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. Leukemia is a cancer that begins in blood-forming
tissue
such as the bone marrow and causes large numbers of blood cells to
be
produced and enter the bloodstream. Lymphomas are cancers that begin
in
cells of the immune system. Myelodysplastic syndromes, also called
preleukemia or smoldering leukemia, are diseases in which the bone
marrow
does not function normally.
|
·
|
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. 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 the toxicities of ifosfamide
and
cyclophosphamide without compromising efficacy. In addition to anticipated
lower toxicity, ZIO-201 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
|
2,520,632
shares
|
|||
Common
stock outstanding before the offering (1)
|
7,248,115
shares
|
|||
Common
stock outstanding after the offering
|
7,248,115
shares
|
|||
Common
stock OTC Bulletin Board trading symbol
|
ZIOP
|
(1)
|
Based
on the number of shares outstanding as of October 31, 2005, not including
1,403,959 shares issuable upon exercise of various warrants and options
to
purchase our common stock.
|
· |
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 an issued U.S. patent
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 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. 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 the toxicities of ifosfamide
and
cyclophosphamide without compromising efficacy. In addition to
anticipated
lower toxicity, ZIO-201 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.
|
· |
fees
and milestone payments required under the license agreements
relating to
our existing product 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.
|
· |
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.
|
65
|
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.
|
42
|
Director
|
Annual
Compensation
|
Long-Term
Compensation Awards
|
|||||||||||||||
Name
and Principal Position
|
Year
|
Salary
($)
|
Bonus
($)
|
Other
Annual Compensation ($)
|
Securities
Underlying Options (#)
|
|||||||||||
Dr.
Jonathan Lewis,
|
||||||||||||||||
Chief
Executive Officer (1)
|
2004
|
344,167
|
500,000
|
(2)
|
9,099
|
|
268,653
|
|||||||||
Richard
Bagley,
|
||||||||||||||||
President,
Chief Operating Officer and Treasurer (3)
|
2004
|
43,750
|
75,000
|
(4)
|
4,057
|
150,668
|
||||||||||
Dr.
Robert Peter Gale,
|
||||||||||||||||
Senior
Vice President Research (5)
|
2004
|
239,583
|
150,000
|
(6)
|
2,543
|
25,110
|
||||||||||
David
C. Olson
|
||||||||||||||||
Former
Chief Executive Officer (7)
|
2004
|
0
|
—
|
—
|
—
|
|||||||||||
2003
|
0
|
—
|
—
|
—
|
||||||||||||
2002
|
0
|
—
|
—
|
—
|
(1)
|
Dr.
Lewis became our Chief Executive Officer effective as of the
Merger. Prior
to the Merger, Dr. Lewis served as Chief Executive Officer
of ZIOPHARM,
Inc. since January 8, 2004.
|
(2)
|
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.
|
(3)
|
Mr.
Bagley became the President, Chief Operating Officer and Treasurer
of the
Company effective as of the Merger. Prior to the Merger, Mr.
Bagley served
President and Chief Operating Officer of ZIOPHARM, Inc. since
July 21,
2004 and as Treasurer of ZIOPHARM, Inc. since March, 2005.
|
(4)
|
Mr.
Bagley received a signing bonus of $50,000 on July 15, 2004
and was due
$25,000, a portion of his guaranteed bonus, as of December
31,
2004.
|
(5)
|
Dr.
Gale became the Company’s Senior Vice President Research effective as of
the Merger. Prior to the Merger, Dr. Gale served as Senior
Vice President
Research of ZIOPHARM, Inc. since January 15, 2004.
|
(6)
|
Includes
a guaranteed bonus of $150,000 for work performed in fiscal
2004 that was
paid on April 16, 2005.
|
(7)
|
During
fiscal year 2004, Mr. Olson received no cash compensation for
services
rendered in his capacity as our President, Chief Operating
Officer and
Treasurer. Mr. Olson resigned as an executive officer effective
upon the
Merger and, in connection with the Merger, we paid Mr. Olson
a one-time
fee of $57,500 pursuant to his December 9, 2004 employment
agreement.
|
Name
|
Number
of Securities Underlying Options Granted (#)
|
Percent
of Total Options Granted to Employees In Fiscal
Year
|
Exercise
of Base Price ($/share)
|
Expiration
Date(s)
|
|||||||||
Dr.
Jonathan Lewis (1)
|
25,674
|
5.2%
|
|
$0.08
|
1/8/14
|
||||||||
Dr.
Jonathan Lewis (1)
|
242,979
|
48.9%
|
|
$0.08
|
1/27/14
|
||||||||
Richard
Bagley (2)
|
150,668
|
30.4%
|
|
$1.70
|
7/1/14
|
||||||||
Dr.
Robert Peter Gale
|
2,567
|
0.5%
|
|
$0.44
|
1/15/14
|
||||||||
Dr.
Robert Peter Gale
|
22,543
|
4.5%
|
|
$0.44
|
1/27/14
|
||||||||
David
C. Olson
|
0
|
0%
|
|
—
|
—
|
(1)
|
The
number of securities underlying options is subject to an anti-dilution
provision pursuant to which Dr. Lewis is 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.
|
(2)
|
The
number of securities underlying options is subject to an anti-dilution
provision pursuant to which Mr. Bagley is entitled to purchase no
less
than 3% of the Company’s common stock until such time as the Company has
raised $25 million in financing.
|
Name
|
Shares
Acquired on Exercise (#)
|
Value
Realized ($)
|
Number
of Unexercised Securities Underlying Options at FY-End (#) Exercisable
/
Unexercisable
|
Value
of Unexercised In-the-Money Options at FY-End ($) Exercisable /
Unexercisable(1)
|
|||||||||
Dr.
Jonathan Lewis
|
0
|
0
|
0
/
268,653
|
0
/
1,136,873
|
|||||||||
Richard
Bagley
|
0
|
0
|
0
/
150,668
|
0
/ 393,982
|
|||||||||
Dr.
Robert Peter Gale
|
0
|
0
|
0
/
25,110
|
0
/ 97,237
|
|||||||||
David
C. Olson
|
0
|
0
|
0
/
0
|
0
/
0
|
(1)
|
Value
of unexercised in-the-money options on December 31, 2004 is based
on a
$2.16 per share value of ZIOPHARM, Inc. stock ($4.31 per share of
the
Company's common stock on a post-Merger basis), as determined
by the
ZIOPHARM, Inc. Board of Directors at such time. As of December 31,
2004,
no trades of the Company’s common stock had been conducted on the
Over-the-Counter Bulletin Board.
|
Name
and Address of Beneficial Owner
|
Shares
of
Common
Stock
Beneficially
Owned (#)(1)
|
Percentage
of
Common
Stock
Beneficially
Owned (%)
|
|||||
Dr.
Jonathan Lewis (2)
|
136,868
|
1.85%
|
|||||
Richard
Bagley (3)
|
80,428
|
1.10%
|
|||||
Robert
Peter Gale (4)
|
8,371
|
*
|
|||||
Murray
Brennan (5)
|
7,515
|
*
|
|||||
James
Cannon (5)
|
7,515
|
*
|
|||||
Hon.
Wyche Fowler (5)
|
7,515
|
*
|
|||||
Gary
S. Fragin (5)
|
7,515
|
*
|
|||||
Timothy
McInerney (6)
|
79,972
|
1.10%
|
|||||
Michael
Weiser (7)
|
126,526
|
1.74%
|
|||||
All
current executive officers and directors
as
a group (8)
|
462,225
|
6.11%
|
|||||
Mibars,
LLC
365
West End Avenue
New
York, NY 10024
|
1,214,456
|
16.76%
|
|||||
Lindsay
A. Rosenwald (9)
787
Seventh Avenue, 48th Floor
New
York, NY 10019
|
1,498,087(9)
|
|
19.89%
|
||||
Atlas
Equity I, Ltd.
181
W. Madison, Suite 3600
Chicago,
IL 60602
|
695,797
|
9.60%
|
|||||
Lester
E. Lipschutz
1650
Arch Street, 22nd Floor
Philadelphia,
PA 19103
|
463,864(10)
|
|
6.40%
|
||||
David
C. Olson (11)
6025
South Quebec Street, Suite 135
Englewood,
CO 80111
|
60,980(11)
|
|
*
|
(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
136,868 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
8,371 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 319,575
shares issuable upon the exercise of convertible securities that
are
currently exercisable or will become exercisable within the next
60
days.
|
(9)
|
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 737,777
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.
|
(10)
|
Includes
463,864 shares held by separate trusts for the benefit of Dr. Rosenwald
or
his family with respect to which Mr. Lifschutz is either trustee
or
investment manager and has investment and voting power. Dr. Rosenwald
disclaims beneficial ownership of these
shares.
|
(11)
|
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
corporation is wholly-owned by Mr.
Olson.
|
|
Price
Range
|
||||||
Fiscal
Year 2005 (Quarter Ended)
|
High
|
Low
|
|||||
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
|
Shares
|
Number
of
|
Percentage
|
|
Beneficially
|
Outstanding
Shares
|
Bedeficial
|
|
Owned
Before
|
Offered
by Selling
|
Ownership
After
|
|
Selling
Stockholder
|
Offering
(1)
|
Stockholder
|
Offering
(2)
|
Lindsay
A. Rosenwald (3)
|
1,498,087
|
476,678
|
13.56%
|
Michael
Weiser
|
126,526
|
83,445
|
*
|
Jason
Stein
|
83,445
|
83,445
|
-
|
Jeffrey
Serbin
|
91,036
|
91,036
|
-
|
Stephen
Rocamboli
|
40,677
|
40,677
|
-
|
Jay
Lobell
|
59,156
|
59,156
|
-
|
Jillian
Hoffman
|
7,590
|
7,590
|
-
|
William
Corcoran
|
12,145
|
12,145
|
-
|
Kyle
Kuhn
|
6,072
|
6,072
|
-
|
David
Butera
|
60,723
|
60,723
|
-
|
Peter
Barber
|
3,036
|
3,036
|
-
|
Anil
Chenthitta
|
3,036
|
3,036
|
-
|
Matthew
Wyckoff
|
3,036
|
3,036
|
-
|
David
Nussbaum
|
3,036
|
3,036
|
-
|
Timothy
McInerney
|
69,972
|
59,205
|
*
|
Michael
Rosenman
|
31,854
|
12,145
|
*
|
John
Knox
|
9,108
|
9,108
|
-
|
Jennifer
McNealy
|
5,465
|
5,465
|
-
|
John
Cipriano
|
5,465
|
5,465
|
-
|
Elena
Ridloff
|
5,465
|
5,465
|
-
|
Louis
Smookler
|
12,145
|
12,145
|
-
|
Donna
Lozito
|
6,072
|
6,072
|
-
|
Scott
Katzmann
|
28,817
|
9,108
|
*
|
John
Papadimitropoulos
|
3,036
|
3,036
|
-
|
Basil
Christakos
|
6,072
|
6,072
|
-
|
Eric
Lee
|
3,036
|
3,036
|
-
|
Timothy
Shands
|
3,036
|
3,036
|
-
|
Claudia
Donat
|
3,036
|
3,036
|
-
|
John
Best
|
1,822
|
1,822
|
-
|
Elbert
Chu
|
1,822
|
1,822
|
-
|
Allison
Robbins
|
1,518
|
1,518
|
-
|
Jamie
Cabibihan
|
1,768
|
1,768
|
-
|
Bernard
Gross
|
10,285
|
1,518
|
*
|
Peter
Kash
|
83,445
|
83,445
|
-
|
David
Tanen
|
12,145
|
12,145
|
-
|
Jill
Meleski
|
19,674
|
3,036
|
*
|
Aaron
Rollins
|
3,036
|
3,036
|
-
|
Delores
Ferraro
|
1,518
|
1,518
|
-
|
Kristen
Plonisch
|
1,518
|
1,518
|
-
|
Marion
Birch
|
1,518
|
1,518
|
-
|
Nicole
Netolicky
|
1,518
|
1,518
|
-
|
Elizabeth
Marrero
|
1,518
|
1,518
|
-
|
Gabriel
Pilaloa
|
1,518
|
1,518
|
-
|
Demitrios
Marras
|
1,518
|
1,518
|
-
|
Kathleen
Fogerty
|
1,518
|
1,518
|
-
|
Danielle
Flatly
|
1,518
|
1,518
|
-
|
Jeana
Sommers
|
1,808
|
1,518
|
-
|
Karl
Ruggeberg
|
9,368
|
1,518
|
*
|
Mibars,
LLC
|
1,214,456
|
1,214,456
|
-
|
Joshua
Kazam and Joia Kazam JTWROS
|
12,145
|
12,145
|
-
|
Mark
O. Thornton
|
8,370
|
8,370
|
-
|
Chase Financing, Inc. |
83,348
|
83,348
|
|
Total
|
2,520,632
|
*
|
Less
than 1%
|
(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 such selling
stockholder.
|
(3) |
In
addition to 476,678 shares of common stock being offered hereunder,
this
amounts includes to 221,011 shares issuable upon the exercise
of warrants
held by Dr. Rosenwald, 62,621 shares issuable upon the exercise
of
warrants granted to Paramount BioCapital Investments, LLC, of
which Dr.
Rosenwald is the managing member, and 737,777 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, Inc.:
|
||
Report
of Vitale, Caturano & Company
|
F-1
|
|
Balance
Sheets as at December 31, 2004 and December 31, 2003
|
F-2
|
|
Statements
of Operations for the Year Ended December 31, 2004 and For
the Periods
from Inception (September 9, 2003) through December 31, 2003
and 2004
|
F-3
|
|
Statements
of Stockholders’ Equity (Deficit) for the Year Ended December 31, 2004 and
For the Periods from Inception (September 9, 2003) through
December 31,
2003 and 2004
|
F-4
|
|
Statements
of Cash Flows for the Year Ended December 31, 2004 and For
the Periods
from Inception (September 9, 2003) through December 31, 2003
and 2004
|
F-5
|
|
Notes
to Consolidated Financial Statements
|
F-7
|
|
Audited
Financial Statements of EasyWeb, Inc.:
|
||
Report
of Cordovano and Honeck, P.C.
|
F-21
|
|
Balance
Sheets as of December 31, 2004
|
F-22
|
|
Statements
of Operations for the Year Ended December 31, 2004, and December
31,
2003
|
F-23
|
|
Statement
of Stockholders’ Deficit for the Year Ended December 31,
2004
|
F-24
|
|
Statement
of Cash Flows for the Years Ended December 31, 2004, and December
31,
2003
|
F-25
|
|
Notes
to Financial Statements
|
F-26
|
Unaudited
Interim Financial Statements of ZIOPHARM Oncology,
Inc.:
|
||
Balance
Sheets as of September 30, 2005 (unaudited) and December 31,
2004
|
F-32
|
|
Statement
of Operations for the three and nine months ended September 30,
2005 and
2004 and for the period from inception (September 9, 2003) to
September
30, 2005
|
F-33
|
|
Statement
of Cash Flows for the nine months ended September 30, 2005 and
2004 and
for the period from inception (September 9, 2003) to September
30,
2005
|
F-34
|
|
Statement
of changes in Convertible Preferred Stock and Stockholders’
Equity/(Deficit) for the nine months ended September 30, 2005
(unaudited)
and for the year ended December 31, 2004 and for the period from
inception
(September 9, 2003) to December 31, 2003
|
F-35
|
|
Notes
to Unaudited Financial Statements
|
F-36
|
ZIOPHARM,
Inc.
|
||
(A
Development Stage Enterprise)
|
||
Balance
Sheets
|
||
December
31, 2004 and 2003
|
||
|
|
|
2004
|
2003
|
||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
1,026,656
|
$
|
402,363
|
|||
Prepaid
expenses and other current assets
|
117,571
|
—
|
|||||
Total
current assets
|
1,144,227
|
402,363
|
|||||
Property
and equipment, net
|
240,733
|
—
|
|||||
Deposits
|
60,046
|
—
|
|||||
$
|
1,445,006
|
$
|
402,363
|
||||
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
709,947
|
$
|
62,499
|
|||
Accrued
expenses
|
879,376
|
—
|
|||||
Total
current liabilities
|
1,589,323
|
62,499
|
|||||
Commitments
and contingencies
|
|||||||
Stockholders'
equity (deficit):
|
|||||||
Series
A convertible preferred stock,
|
|||||||
$.001
par value; 20,000,000 shares authorized; no
|
|||||||
shares
issued and outstanding at December 31, 2004
|
|||||||
and
December 31, 2003, respectively
|
—
|
—
|
|||||
Common
stock, $.001 par value; 30,000,000 shares
authorized;
|
|||||||
5,512,500
and 500,000 shares issued and outstanding
|
|||||||
at
December 31, 2004 and December 31, 2003, respectively
|
5,513
|
500
|
|||||
Additional
paid-in capital
|
5,697,603
|
499,500
|
|||||
Deficit
accumulated during the development stage
|
(5,847,433
|
)
|
(160,136
|
)
|
|||
Total
stockholders' equity (deficit)
|
(144,317
|
)
|
339,864
|
||||
$
|
1,445,006 |
$
|
402,363 |
ZIOPHARM,
Inc.
|
|||
(A
Development Stage Enterprise)
|
|||
Statements
of Operations
|
|||
Year
Ended December 31, 2004 and
|
|||
For
the Periods from Inception (September 9, 2003) through December
31, 2003
and 2004
|
|||
For
the Period
|
For
the Period
|
|||||||||
from
Inception
|
from
Inception
|
|||||||||
(September
9, 2003)
|
(September
9, 2003)
|
|||||||||
Year
Ended
|
through
|
through
|
||||||||
December
31,
|
December
31,
|
December
31,
|
||||||||
2004
|
2003
|
2004
|
||||||||
Research
contract revenue
|
$
|
—
|
$
|
—
|
$
|
—
|
||||
Operating
expenses:
|
||||||||||
Research
and development, including
|
||||||||||
costs
of research contracts
|
2,126,607
|
—
|
2,126,607
|
|||||||
General
and administrative
|
3,581,959
|
160,634
|
3,742,593
|
|||||||
Total
operating expenses
|
5,708,566
|
160,634
|
5,869,200
|
|||||||
Loss
from operations
|
(5,708,566
|
)
|
(160,634
|
)
|
(5,869,200
|
)
|
||||
Interest
income
|
21,269
|
498
|
21,767
|
|||||||
Net
loss
|
$
|
(5,687,297
|
)
|
$
|
(160,136
|
)
|
$
|
(5,847,433
|
)
|
|
Basic
and diluted net loss per share
|
$
|
(1.19
|
)
|
$
|
(1.02
|
)
|
||||
Weighted
average common shares outstanding
|
||||||||||
used
to compute basic and diluted net loss per share
|
4,794,692
|
156,336
|
ZIOPHARM,
Inc.
|
|||||||
(A
Development Stage Enterprise)
|
|||||||
Statements
of Changes in Stockholders' Equity (Deficit)
|
|||||||
Year
Ended December 31, 2004 and
|
|||||||
For
the Periods from Inception (September 9, 2003) through December
31, 2003
and 2004
|
|||||||
|
Deficit
|
||||||||||||||||||||||
Series
A
|
Accumulated
|
Total
|
||||||||||||||||||||
Convertible
|
Additional
|
during
the
|
Stockholders'
|
|||||||||||||||||||
Preferred
Stock
|
Common
Stock
|
Paid-in
|
Development
|
Equity
|
||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Stage
|
(Deficit)
|
||||||||||||||||
Stockholders'
contribution, September 9, 2003
|
—
|
$
|
—
|
500,000
|
$
|
500
|
$
|
499,500
|
$
|
—
|
$
|
500,000
|
||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
(160,136
|
)
|
(160,136
|
)
|
|||||||||||||
Balance
at December 31, 2003
|
—
|
—
|
500,000
|
500
|
499,500
|
(160,136
|
)
|
339,864
|
||||||||||||||
Issuance
of common stock
|
—
|
—
|
4,500,000
|
4,500
|
4,495,500
|
—
|
4,500,000
|
|||||||||||||||
Issuance
of common stock for services
|
—
|
—
|
512,500
|
513
|
438,326
|
—
|
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
|
—
|
$
|
—
|
5,512,500
|
$
|
5,513
|
$
|
5,697,603
|
$
|
(5,847,433
|
)
|
$
|
(144,317
|
)
|
ZIOPHARM,
Inc.
|
|||
(A
Development Stage Enterprise)
|
|||
Statements
of Cash Flows
|
|||
Year
Ended December 31, 2004 and
|
|||
For
the Periods from Inception (September 9, 2003) through
December 31, 2003
and 2004
|
|||
|
For
the Period
|
For
the Period
|
|||||||||
from
Inception
|
from
Inception
|
|||||||||
(September
9, 2003)
|
(September
9, 2003)
|
|||||||||
Year
Ended
|
through
|
through
|
||||||||
December
31,
|
December
31,
|
December
31,
|
||||||||
2004
|
2003
|
2004
|
||||||||
Cash
flows from operating activities:
|
||||||||||
Net
loss
|
$
|
(5,687,297
|
)
|
$
|
(160,136
|
)
|
$
|
(5,847,433
|
)
|
|
Adjustments
to reconcile net loss to net cash
|
||||||||||
used
in operating activities:
|
||||||||||
Depreciation
and amortization
|
33,953
|
—
|
33,953
|
|||||||
Stock-based
compensation
|
703,116
|
—
|
703,116
|
|||||||
Change
in operating assets and liabilities:
|
||||||||||
(Increase)
in:
|
||||||||||
Prepaid
expenses and other current assets
|
(117,571
|
)
|
—
|
(117,571
|
)
|
|||||
Increase
(decrease) in:
|
||||||||||
Accounts
payable
|
647,448
|
62,499
|
709,947
|
|||||||
Accrued
expenses
|
879,376
|
—
|
879,376
|
|||||||
Deposits
|
(60,046
|
)
|
—
|
(60,046
|
)
|
|||||
Net
cash used in operating activates
|
(3,601,021
|
)
|
(97,637
|
)
|
(3,698,658
|
)
|
||||
Cash
flows from investing activities:
|
||||||||||
Purchases
of property and equipment
|
(274,686
|
)
|
—
|
(274,686
|
)
|
|||||
Net
cash used in investing activities
|
(274,686
|
)
|
—
|
(274,686
|
)
|
|||||
Cash
flows from financing activities:
|
||||||||||
Stockholders'
capital contribution
|
—
|
500,000
|
500,000
|
|||||||
Proceeds
from issuance of common stock
|
4,500,000
|
—
|
4,500,000
|
|||||||
Net
cash provided by financing activities
|
4,500,000
|
500,000
|
5,000,000
|
|||||||
Net
increase in cash and cash equivalents
|
624,293
|
402,363
|
1,026,656
|
|||||||
Cash
and cash equivalents, beginning of period
|
402,363
|
—
|
—
|
|||||||
Cash
and cash equivalents, end of period
|
$
|
1,026,656
|
$
|
402,363
|
$
|
1,026,656
|
ZIOPHARM,
Inc.
|
|||
(A
Development Stage Enterprise)
|
|||
Statements
of Cash Flows…continued
|
|||
Year
Ended December 31, 2004 and
|
|||
For
the Periods from Inception (September 9, 2003) through
December 31, 2003
and 2004
|
|||
|
For
the Period
|
For
the Period
|
|||||||||
from
Inception
|
from
Inception
|
|||||||||
(September
9, 2003)
|
(September
9, 2003)
|
|||||||||
Year
Ended
|
through
|
through
|
||||||||
December
31,
|
December
31,
|
December
31,
|
||||||||
2004
|
2003
|
2004
|
||||||||
Supplementary
disclosure of cash flow information:
|
||||||||||
Cash
paid for interest
|
$
|
—
|
$
|
—
|
$
|
—
|
||||
Cash
paid for income taxes
|
$
|
—
|
$
|
—
|
$
|
—
|
2.
|
SUMMARY
OF SIGNIFICANT ACCOUNTING
POLICIES
|
2.
|
SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES…continued
|
2004
|
2003
|
||||||
Net
loss:
|
|||||||
As
reported
|
$
|
(5,687,297
|
)
|
$
|
(160,136
|
)
|
|
Stock-based
compensation expense included in reported net loss
|
703,116
|
—
|
|||||
Stock-based
compensation expense under the fair value-based method
|
(813,095
|
)
|
—
|
||||
Pro
forma net loss
|
$
|
(5,797,276
|
)
|
$
|
(160,136
|
)
|
|
Basic
and diluted net loss per share:
|
|||||||
As
reported
|
$
|
(1.19
|
)
|
$
|
(1.02
|
)
|
|
Pro
forma
|
$
|
(1.21
|
)
|
$
|
(1.02
|
)
|
2.
|
SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES…continued
|
2004
|
2003
|
||
Expected
life
|
5
years
|
—
|
|
Expected
volatility
|
134%
|
—
|
|
Dividend
yield
|
3.6%
|
—
|
|
Weighted
average risk-free interest rate
|
0
%
|
—
|
3.
|
PROPERTY
AND EQUIPMENT
|
Estimated
|
||||||||||
Useful
Life
|
|
|||||||||
(Years)
|
2004
|
2003
|
||||||||
Computer
equipment
|
3
|
$
|
78,914
|
$
|
—
|
|||||
Office
equipment
|
3
|
|
179,193
|
—
|
||||||
Software
|
3
|
16,579
|
—
|
|||||||
274,686
|
—
|
|||||||||
Less
- accumulated depreciation and amortization
|
|
33,953
|
—
|
|||||||
$
|
240,733
|
$
|
—
|
3.
|
PROPERTY
AND EQUIPMENT...continued
|
4.
|
ACCRUED
EXPENSES
|
2004
|
2003
|
||||||
Employee
compensation
|
$
|
506,391
|
$
|
—
|
|||
Professional
services
|
42,767
|
—
|
|||||
Research
and development consulting services
|
258,218
|
—
|
|||||
Founders
Fee
|
60,000
|
—
|
|||||
Other
|
12,000
|
—
|
|||||
$
|
879,376
|
$
|
—
|
5.
|
RELATED
PARTY TRANSACTIONS
|
5.
|
RELATED
PARTY TRANSACTIONS...continued
|
6.
|
COMMITMENTS
AND CONTINGENCIES
|
Operating
|
||||
Leases
|
||||
2005
|
$
|
93,318
|
||
2006
|
103,434
|
|||
2007
|
114,103
|
|||
2008
|
121,455
|
|||
2009
|
87,699
|
|||
$
|
520,009
|
6.
|
COMMITMENTS
AND CONTINGENCIES...continued
|
6.
|
COMMITMENTS
AND CONTINGENCIES...continued
|
6.
|
COMMITMENTS
AND CONTINGENCIES...continued
|
7.
|
INCOME
TAXES
|
December
31,
|
December
31,
|
||||||
2004
|
2003
|
||||||
Net
operating loss carryforwards
|
$
|
494,881
|
$
|
26,118
|
|||
Start-up
and organizational costs
|
1,502,217
|
—
|
|||||
Research
and development credit carryforwards
|
81,670
|
—
|
|||||
Accrued
bonus
|
200,343
|
—
|
|||||
Depreciation
|
(4,102
|
)
|
—
|
||||
Other
|
8,816
|
—
|
|||||
Net
deferred tax assets
|
2,283,825
|
26,118
|
|||||
Deferred
tax asset valuation allowance
|
(2,283,825
|
)
|
(26,118
|
)
|
|||
|
$ |
—
|
$
|
—
|
8.
|
CONVERTIBLE
PREFERRED STOCK AND STOCKHOLDERS’
EQUITY
|
8.
|
CONVERTIBLE
PREFERRED STOCK AND STOCKHOLDERS’ EQUITY...continued
|
8.
|
CONVERTIBLE
PREFERRED STOCK AND STOCKHOLDERS’ EQUITY...continued
|
9.
|
STOCK
OPTION PLAN
|
|
Weighted-
|
||||||
|
Average
|
||||||
Number
of
|
Exercise
|
||||||
Shares
|
Price
|
||||||
Outstanding,
January 1, 2004
|
—
|
$
|
—
|
||||
Granted
|
1,170,826
|
0.63
|
|||||
Exercised
|
—
|
—
|
|||||
Canceled
|
—
|
—
|
|||||
Outstanding,
December 31, 2004
|
1,170,826
|
$
|
0.63
|
||||
Options
available for future grants
|
1,329,174
|
Options
Outstanding
|
Options
Exercisable
|
|||||||||||||||
Exercise
Price
|
Number
Outstanding
|
Weighted-
Average
Remaining
Contractual
Life
(Years)
|
Weighted-
Average
Exercise
Price
|
Number
Exercisable
|
Weighted-
Average
Exercise
Price
|
|||||||||||
$0.04
|
536,263
|
9.03
|
$
|
0.04
|
—
|
$
|
—
|
|||||||||
$0.22
|
100,250
|
9.08
|
$
|
0.22
|
—
|
$
|
—
|
|||||||||
$0.85
|
353,813
|
9.51
|
$
|
0.85
|
—
|
$
|
—
|
|||||||||
$2.16
|
180,500
|
9.98
|
$
|
2.16
|
500
|
$
|
2.16
|
|||||||||
1,170,826
|
9.33
|
$
|
0.63
|
500
|
$
|
2.16
|
Assets
|
||||
Current
Assets:
|
||||
Cash
|
$
|
21
|
||
Liabilities
and Shareholders’ Deficit
|
||||
Current
Liabilities:
|
||||
Accounts
payable
|
$
|
63
|
||
Accrued
liabilities
|
7,385
|
|||
Due
to officer (Note 2)
|
1,300
|
|||
Due
to affiliate (Note 2)
|
12,298
|
|||
Total
current liabilities
|
21,046
|
|||
Shareholders’
deficit (Notes 4 and 6):
|
||||
Common
stock, no par value; 30,000,000 shares authorized,
|
||||
5,746,200
shares issued and outstanding
|
156,050
|
|||
Stock
options outstanding
|
20,600
|
|||
Additional
paid-in capital
|
87,808
|
|||
Retained
deficit
|
(285,483
|
)
|
||
Total
shareholders’ deficit
|
(21,025
|
)
|
||
$
|
21
|
For
the Years Ended
|
|||||||
December
31,
|
|||||||
2004
|
2003
|
||||||
Operating
expenses:
|
|||||||
Stock-based
compensation (Note 2):
|
|||||||
Director
fees
|
$
|
5,000
|
$
|
—
|
|||
Related
party
|
5,000
|
—
|
|||||
Contributed
rent (Note 2)
|
6,000
|
6,000
|
|||||
Administrative
support
|
173
|
510
|
|||||
Contributed
administrative
|
|||||||
support
(Note 2)
|
11,827
|
11,490
|
|||||
Professional
fees
|
8,535
|
12,812
|
|||||
Web
site consulting and maintenance
|
150
|
120
|
|||||
Dues
and subscriptions
|
1,200
|
2,975
|
|||||
Depreciation
and amortization
|
—
|
486
|
|||||
Other
|
1,281
|
1,449
|
|||||
Total
operating expenses
|
39,166
|
35,842
|
|||||
Loss
before income taxes
|
(39,166
|
)
|
(35,842
|
)
|
|||
Income
tax provision (Note 3)
|
—
|
—
|
|||||
Net
loss
|
$
|
(39,166
|
)
|
$
|
(35,842
|
)
|
|
Basic
and diluted loss per share
|
$
|
(0.01
|
)
|
$
|
(0.01
|
)
|
|
Basic
and diluted weighted average
|
|||||||
common
shares outstanding
|
5,439,533
|
4,672,867
|
Outstanding
|
Additional
|
||||||||||||||||||
Common
Stock
|
Stock
|
Paid-In
|
Retained
|
||||||||||||||||
Shares
|
Amount
|
Options
|
Capital
|
Deficit
|
Total
|
||||||||||||||
Balance
at January 1, 2003
|
4,506,200
|
$
|
120,050
|
$
|
20,600
|
$
|
52,491
|
$
|
(210,475
|
)
|
$
|
(17,334
|
)
|
||||||
March
2003, sale of common stock
|
|||||||||||||||||||
($.05/share)
(Note 4)
|
200,000
|
10,000
|
—
|
—
|
—
|
10,000
|
|||||||||||||
Office
space and administrative support
|
|||||||||||||||||||
contributed
by an affiliate (Note 2)
|
—
|
—
|
—
|
17,490
|
—
|
17,490
|
|||||||||||||
Net
loss, year ended December 31, 2003
|
—
|
—
|
—
|
—
|
(35,842
|
)
|
(35,842
|
)
|
|||||||||||
Balance
at December 31, 2003
|
4,706,200
|
130,050
|
20,600
|
69,981
|
(246,317
|
)
|
(25,686
|
)
|
|||||||||||
March
2004, sale of common stock
|
|||||||||||||||||||
($.025/share)
(Note 4)
|
240,000
|
6,000
|
—
|
—
|
—
|
6,000
|
|||||||||||||
May
2004, common stock issued to an
|
|||||||||||||||||||
affiliate
to repay obligations ($.025/share)
|
|||||||||||||||||||
(Note
2)
|
400,000
|
10,000
|
—
|
—
|
—
|
10,000
|
|||||||||||||
May
2004, common stock issued to a
|
|||||||||||||||||||
related
party in exchange for services
|
|||||||||||||||||||
($.025/share)
(Note 2)
|
200,000
|
5,000
|
—
|
—
|
—
|
5,000
|
|||||||||||||
May
2004, common stock issued to a
|
|||||||||||||||||||
director
in exchange for director fees
|
|||||||||||||||||||
($.025/share)
(Note 2)
|
200,000
|
5,000
|
—
|
—
|
—
|
5,000
|
|||||||||||||
Office
space and administrative support
|
|||||||||||||||||||
contributed
by an affiliate (Note 2)
|
—
|
—
|
—
|
17,827
|
—
|
17,827
|
|||||||||||||
Net
loss, year ended December 31, 2004
|
—
|
—
|
—
|
—
|
(39,166
|
)
|
(39,166
|
)
|
|||||||||||
Balance
at December 31, 2004
|
5,746,200
|
$
|
156,050
|
$
|
20,600
|
$
|
87,808
|
$
|
(285,483
|
)
|
$
|
(21,025
|
)
|
For
the Years Ended
|
|||||||
December
31,
|
|||||||
2004
|
2003
|
||||||
Cash
flows from operating activities:
|
|||||||
Net
loss
|
$
|
(39,166
|
)
|
$
|
(35,842
|
)
|
|
Adjustments
to reconcile net loss to net cash
|
|||||||
used
by operating activities:
|
|||||||
Depreciation
and amortization
|
—
|
486
|
|||||
Stock-based
compensation
|
10,000
|
—
|
|||||
Office
space and administrative support
|
|||||||
contributed
by an affiliate (Note 2)
|
17,827
|
17,490
|
|||||
Changes
in operating assets and liabilities:
|
|||||||
Accounts
payable, accrued expenses
|
|||||||
and
due to affiliate
|
4,027
|
8,534
|
|||||
Net
cash used in
|
|||||||
operating
activities
|
(7,312
|
)
|
(9,332
|
)
|
|||
Cash
flows from financing activities:
|
|||||||
Proceeds
on loans from related parties
|
1,300
|
—
|
|||||
Repayment
of related party loans
|
—
|
(650
|
)
|
||||
Proceeds
from the sale of common stock
|
6,000
|
10,000
|
|||||
Net
cash provided by
|
|||||||
financing
activities
|
7,300
|
9,350
|
|||||
Net
change in cash
|
(12
|
)
|
18
|
||||
Cash,
beginning of period
|
33
|
15
|
|||||
Cash,
end of period
|
$
|
21
|
$
|
33
|
|||
Supplemental
disclosure of cash flow information:
|
|||||||
Cash
paid during the year for:
|
|||||||
Income
taxes
|
$
|
—
|
$
|
—
|
|||
Interest
|
$
|
—
|
$
|
—
|
Years
Ended
|
|||
December
31,
|
|||
2004
|
2003
|
||
U.S.
statutory federal rate
|
15.00%
|
15.00%
|
|
State
income tax rate, net of federal benefit
|
3.94%
|
3.94%
|
|
Permanent
differences
|
-8.62%
|
-9.24%
|
|
Net
operating loss for which no tax
|
|||
benefit
is currently available
|
-10.32%
|
-9.70%
|
|
0.00%
|
0.00%
|
Weighted
|
Weighted
Avg
|
||||||||||||
Options
|
Avg
|
Remaining
|
|||||||||||
Description
|
Options
|
Exercisable
|
Exercise
Price
|
Life
|
|||||||||
Outstanding
at January 1, 2003
|
100,000
|
100,000
|
|
$0.25
|
9
years
|
||||||||
Granted
|
—
|
—
|
—
|
—
|
|||||||||
Exercised
|
—
|
—
|
—
|
—
|
|||||||||
Expired/Cancelled
|
—
|
—
|
|
—
|
—
|
||||||||
Outstanding
at December 31, 2003
|
100,000
|
100,000
|
|
$0.25
|
8
years
|
||||||||
Granted
|
—
|
—
|
—
|
—
|
|||||||||
Exercised
|
—
|
—
|
—
|
—
|
|||||||||
Expired/Cancelled
|
—
|
—
|
—
|
—
|
|||||||||
Outstanding
at December 31, 2004
|
100,000
|
100,000
|
|
$0.25
|
7
years
|
a. |
Mergers
and acquisition;
|
b. |
Due
diligence studies, reorganizations,
divestitures;
|
c. |
Capital
structures, banking methods and
systems;
|
d. |
Periodic
reporting as to the developments concerning the general financial
markets
and public securities markets and industry which may be relevant
or of
interest or concern to the Company or the Company’s
business;
|
e. |
Guidance
and assistance in available alternatives for accounts receivable
financing
and/or other asset financing; and
|
f. |
Structural
recommendations to assist the Company’s capability to
finance.
|
a. |
Mergers
and acquisition;
|
b. |
Due
diligence studies, reorganizations,
divestitures;
|
c. |
Capital
structures, banking methods and
systems;
|
d. |
Periodic
reporting as to the developments concerning the general financial
markets
and public securities markets and industry which may be relevant
or of
interest or concern to the Company or the Company’s
business;
|
e. |
Guidance
and assistance in available alternatives for accounts receivable
financing
and/or other asset financing; and
|
f. |
Conclude
business and transactions necessary to keep the Company current
in all
public filings, a-float and in business until an aforementioned
business
transaction is closed, to include lending funds to the Company
when
absolutely necessary as has been done over the prior three years
at no
charge, allowing the Company to
survive.
|
a. |
Reincorporate
the Company in the State of
Delaware;
|
b. |
Authorize
the Board of Directors to implement a reverse stock split at a
ratio no
greater than 40:1;
|
c. |
Increase
the Company’s authorized capital by 250,000,000 shares (from 30,000,000 to
280,000,000);
|
ZIOPHARM
Oncology, Inc.
|
|||||||
(A
Development Stage Enterprise)
|
|||||||
Balance
Sheets
|
|||||||
September
30, 2005
|
December
31, 2004
|
||||||
|
Unaudited
|
||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
10,740,639
|
$
|
1,026,656
|
|||
Prepaid
expenses and other current assets
|
209,816
|
117,571
|
|||||
Total
current assets
|
10,950,455
|
1,144,227
|
|||||
Property
and equipment, net
|
232,862
|
240,733
|
|||||
Deposits
|
36,032
|
60,046
|
|||||
Other
non current assets
|
92,812
|
-
|
|||||
Total
assets
|
$
|
11,312,161
|
$
|
1,445,006
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
477,389
|
$
|
709,947
|
|||
Accrued
expenses
|
1,270,624
|
879,376
|
|||||
Total
current liabilities
|
1,748,013
|
1,589,323
|
|||||
|
- |
-
|
|||||
Commitments
and contingencies
|
|||||||
Stockholders'
deficit:
|
|||||||
Common
stock, $.001 par value; 280,000,000 shares
authorized;
|
|||||||
7,241,211
and 2,761,621 shares issued and outstanding
|
|||||||
at September
30, 2005 and December 31, 2004, respectively
|
7,241
|
2,761
|
|||||
Additional
paid-in capital
|
22,460,147
|
5,700,355
|
|||||
Deficit
accumulated during the development stage
|
(12,903,240
|
)
|
(5,847,433
|
)
|
|||
Total
stockholders' equity (deficit)
|
9,564,148
|
(144,317
|
)
|
||||
Total
liabilities and stockholders' equity (deficit)
|
$
|
11,312,161
|
$
|
1,445,006
|
ZIOPHARM
Oncology, Inc.
|
||||||||||||||||
(A
Development Stage Enterprise)
|
||||||||||||||||
Statements
of Operations
|
||||||||||||||||
For
the three and nine months ended September 30, 2005
and 2004 and for the
period from inception (September 9, 2003) through September
30, 2005
(unaudited)
|
||||||||||||||||
|
|
|
|
|
|
|
|
For
the Period
|
|
|||||||
|
|
|
|
|
|
|
|
|
|
from
Inception
|
|
|||||
For
the three
|
|
For
the three
|
|
For
the nine
|
|
For
the nine
|
|
(September
9,
|
||||||||
months
|
months
|
months
|
months
|
2003)
|
||||||||||||
|
|
ended
|
|
ended
|
|
ended
|
|
ended
|
|
through
|
|
|||||
|
|
September
30, 2005
|
|
September
30,
2004
|
|
September
30,
2005
|
|
September
30,
2004
|
|
September
30,
2005
|
||||||
Revenue
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
||||||
Operating
expenses and other income:
|
||||||||||||||||
Research
and development, including
|
||||||||||||||||
costs
of research contracts
|
1,318,608
|
425,428
|
4,279,687
|
425,428
|
6,406,294
|
|||||||||||
General
and administrative
|
1,541,740
|
928,174
|
2,953,830
|
2,646,084
|
6,696,423
|
|||||||||||
Total
operating expenses
|
2,860,348
|
1,353,602
|
7,233,517
|
3,071,512
|
13,102,717
|
|||||||||||
Loss
from operations
|
(2,860,348
|
)
|
(1,353,602
|
)
|
(7,233,517
|
)
|
(3,071,512
|
)
|
(13,102,717
|
)
|
||||||
Interest
income
|
94,231
|
5,229
|
177,710
|
15,471
|
199,477
|
|||||||||||
Net
loss
|
$
|
(2,766,117
|
)
|
$
|
(1,348,373
|
)
|
$
|
(7,055,807
|
)
|
$
|
(3,056,041
|
)
|
$
|
(12,903,240
|
)
|
|
Basic
and diluted net loss per share
|
$
|
(0.77
|
)
|
$
|
(0.52
|
)
|
$
|
(2.32
|
)
|
$
|
(1.34
|
)
|
||||
Weighted
average common shares outstanding used to
|
||||||||||||||||
compute
basic and diluted net loss per share
|
3,593,109
|
2,611,873
|
3,041,829
|
2,280,832
|
||||||||||||
ZIOPHARM
Oncology, Inc.
|
||||||||||
(A
Development Stage Enterprise)
|
||||||||||
Statements
of Cash Flows
|
||||||||||
For
the nine months ended September 30, 2005 and 2004
and for the period from
inception(September 9, 2003) through September 30,
2005
(unaudited)
|
||||||||||
|
|
|
|
|
|
|||||
|
|
|
|
|
|
For
the Period
|
|
|||
For
the
|
For
the
|
from
Inception
|
||||||||
|
|
Nine
months
|
|
Nine
months
|
|
(September
9, 2003)
|
|
|||
|
|
ended
|
|
ended
|
|
through
|
|
|||
|
|
September
30, 2005
|
|
September
30, 2004
|
|
September
30, 2005
|
||||
Cash
flows from operating activities:
|
||||||||||
Net
loss
|
$
|
(7,055,807
|
)
|
$
|
(3,056,041
|
)
|
$
|
(12,903,240
|
)
|
|
Adjustments
to reconcile net loss to net cash
|
||||||||||
used
in operating activities:
|
||||||||||
Depreciation
and amortization
|
72,519
|
25,177
|
106,472
|
|||||||
Stock-based
compensation
|
-
|
- |
703,116
|
|||||||
Change
in operating assets and liabilities:
|
||||||||||
Increase
in:
|
||||||||||
Prepaid
expenses and other current assets
|
(92,245
|
)
|
(52,054
|
)
|
(209,816
|
)
|
||||
Other
noncurrent assets
|
(92,812
|
)
|
-
|
(92,812
|
)
|
|||||
Increase
(decrease) in:
|
||||||||||
Deposits
|
24,014
|
(69,246
|
)
|
(36,032
|
)
|
|||||
Accounts
payable
|
(232,558
|
)
|
202,673
|
477,389
|
||||||
Accrued
expenses
|
391,248
|
387,103
|
1,270,624
|
|||||||
Net
cash used in operating activates
|
(6,985,641
|
)
|
(2,562,388
|
)
|
(10,684,299
|
)
|
||||
Cash
flows from investing activities:
|
||||||||||
Purchases
of property and equipment
|
(64,648
|
)
|
(133,077
|
)
|
(339,334
|
)
|
||||
Net
cash used in investing activities
|
(64,648
|
)
|
(133,077
|
)
|
(339,334
|
)
|
||||
Cash
flows from financing activities:
|
||||||||||
Stockholders'
capital contribution
|
-
|
-
|
500,000
|
|||||||
Proceeds
from issuance of common stock, net
|
4,676
|
4,500,000
|
4,504,676
|
|||||||
Proceeds
from issuance of preferred stock, net
|
16,759,596
|
-
|
16,759,596
|
|||||||
Net
cash provided by financing activities
|
16,764,272
|
4,500,000
|
21,764,272
|
|||||||
Net
increase in cash and cash equivalents
|
9,713,983
|
1,804,535
|
10,740,639
|
|||||||
Cash
and cash equivalents, beginning of period
|
1,026,656
|
402,363
|
-
|
|||||||
Cash
and cash equivalents, end of period
|
$
|
10,740,639
|
$
|
2,206,898
|
$
|
10,740,639
|
||||
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 nine months ended September 30, 2005 (unaudited),
For the Year ended
December 31, 2004 and
|
|||||||||||||||||||||||||
For
the Period from Inception (September 9, 2003) to December
31,
2003
|
|||||||||||||||||||||||||
Convertible
Preferred Stock and Warrants
|
|
Stockholder's
Equity (Deficit)
|
|
||||||||||||||||||||||
|
|
|
|
|
|
Warrants
to
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
|
|
|
Purchase
Series
A
|
|
|
|
|
|
|
|
Deficit
|
|
|
|
||||||||||
|
|
Series
A
|
|
Convertible
|
|
|
|
|
|
|
|
Accumulated
|
|
Total
|
|
||||||||||
|
|
Convertible
|
|
Preferred
|
Additional
|
during
the
|
Stockholders'
|
||||||||||||||||||
|
|
Preferred
Stock
|
|
Stock
|
|
Common
Stock
|
|
Paid-in
|
|
Development
|
|
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 (audited)
|
-
|
-
|
-
|
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 (audited)
|
-
|
-
|
-
|
2,761,625
|
2,761
|
5,700,355
|
(5,847,433
|
)
|
(144,317
|
)
|
|||||||||||||||
Issuance
of Series A convertible preferred stock
|
8,379,564
|
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
|
(8,379,564
|
)
|
(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
|
-
|
-
|
-
|
91,718
|
92
|
4,584
|
-
|
4,676
|
|||||||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
-
|
(7,055,807
|
)
|
(7,055,807
|
)
|
|||||||||||||||
Balance
at September 30, 2005 (unaudited)
|
-
|
$
|
-
|
$
|
-
|
7,241,211
|
$
|
7,241
|
$
|
22,460,147
|
$
|
(12,903,240
|
)
|
$
|
9,564,148
|
1.
|
BASIS
OF PRESENTATION AND
OPERATIONS
|
2. |
STOCK
BASED COMPENSATION
|
Three
months ended
September
30,
|
Nine
months ended
September
30,
|
||||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
Net
loss:
|
|||||||||||||
As
reported
|
$
|
(2,766,117
|
)
|
$
|
(1,348,373
|
)
|
$
|
(7,055,807
|
$
|
(3,056,041
|
)
|
||
Stock-based
compensation expense included in reported net loss
|
---
|
---
|
---
|
---
|
|||||||||
Stock-based
compensation expense under the fair value-based method
|
(176,297
|
)
|
(33,958
|
)
|
(340,197
|
)
|
(60,683
|
)
|
|||||
Pro
forma net loss
|
$
|
(2,942,414
|
)
|
$
|
(1,382,331
|
)
|
$
|
(7,396,004
|
)
|
$
|
(3,116,724
|
)
|
|
Basic
and diluted net loss per share:
|
|||||||||||||
As
reported
|
$
|
(0.77
|
)
|
$
|
(0.52
|
)
|
$
|
(2.32
|
)
|
$
|
(1.34
|
)
|
|
Pro
forma
|
$
|
(0.82
|
)
|
$
|
(0.53
|
)
|
$
|
(2.43
|
)
|
$
|
(1.37
|
)
|
Three
months ended
September
30,
|
Nine
months ended
September
30,
|
||||||
2005
|
2004
|
2005
|
2004
|
||||
Expected
life
|
5
years
|
5
years
|
5
years
|
5
years
|
|||
Expected
volatility
|
172%
|
134%
|
172%
|
114%
|
|||
Dividend
yield
|
0%
|
0%
|
0%
|
0%
|
|||
Weighted
average risk-free interest rate
|
4.01%
|
3.60%
|
4.01%
|
3.60%
|
3.
|
CONVERTIBLE
PREFERRED STOCK AND STOCKHOLDERS’
EQUITY
|
4.
|
RELATED
PARTY TRANSACTIONS
|
5.
|
STOCK
OPTION PLAN
|
6.
|
COMMITMENTS
AND CONTIGENCIES
|