Delaware
|
84-1475642
|
|
(State
or Other Jurisdiction of Incorporation or Organization)
|
(IRS
Employer Identification No.)
|
|
1180
Avenue of the Americas, 19th
Floor, New York, NY
|
10036
|
|
(Address
of Principal Executive Offices)
|
(Zip
Code)
|
Page
|
|||
PART
I
|
|||
Item
1.
|
Description
of Business
|
4
|
|
Item
2.
|
Description
of Property
|
19
|
|
Item
3.
|
Legal
Proceedings
|
20
|
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
20
|
|
PART
II
|
|||
Item
5.
|
Market
for Common Equity, Related Stockholders Matters and Small Business
Issuer
Purchases of Equity Securities
|
20
|
|
Item
6.
|
Management’s
Discussion and Analysis or Plan of Operation
|
20
|
|
Item
7.
|
Financial
Statements
|
26
|
|
Item
8.
|
Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosures
|
27
|
|
Item
8A.
|
Controls
and Procedures
|
27
|
|
Item
8B.
|
Other
Information
|
28
|
|
PART
III
|
|||
Item
9.
|
Directors,
Executive Officers, Promoters and Control Persons; Compliance with
Section
16(a) of the Exchange Act
|
29
|
|
Item
10.
|
Executive
Compensation
|
29
|
|
Item
11.
|
Security
Owners of Certain Beneficial Owners and Management and Related
Stockholders Matters
|
29
|
|
Item
12.
|
Certain
Relationships and Related Transactions
|
29
|
|
Item
13.
|
Exhibits
|
30
|
|
Item
14.
|
Principal
Accountant Fees and Services
|
31
|
|
Signatures
|
32
|
||
Exhibit
Index
|
33
|
·
|
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.
|
·
|
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.
|
|
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
|
·
|
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.
|
|
Phase I testing of ZIO-101 is ongoing with two safety and dose finding studies at The University of Texas M. D. Anderson Cancer Center (“MDACC”). As of December 2, 2005, monitored safety data for 8 patients enrolled in the ongoing phase I clinical study (blood cancers) through to completion at the 109 mg/m2 (milligrams per meter squared) dose-level cohort are available. The ongoing phase I study in solid cancers recently completed the 420 mg/m2/d x 5 d dose level with no dose limiting toxicities identified. Monitored safety data, as of November 30, 2005, is available for 16 subjects through to completion of enrollment at the 214 mg/m2 dose level cohort. The Company has seen encouraging signs of clinical activity in both of these studies including impact on blood and bone marrow blast cells in patients with acute myelogenous leukemia (AML) and one patient with metastatic renal cell carcinoma where metastasis to the brain resolved. The Company recently initiated a phase I/II advanced multiple myeloma study to be conducted in the U.S., Canada and Europe designed to determine maximum tolerated dose and to assess clinical activity in this specific indication. This study began at a dose of 109 mg/m2 utilizing the same dosing regimen as the ongoing phase I studies. The Company expects to pursue registration in the U.S. for the treatment of advanced multiple myeloma with a potentially pivotal trial to begin in 2007. |
·
|
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.
|
|
Phase
I testing of ZIO-201 is ongoing at two sites in the U.S. (Karmanos
Cancer
Center at Wayne State University in Detroit and Premiere Oncology
in Los
Angeles). This study is treating patients at a dose of 787 mg/m2
with no
dose limiting toxicities identified. IPM has been administered without
the
“uroprotectant” mesna and the toxicities associated with acrolein and
chloroacetaldehyde have not been observed. Kidney toxicity seen with
ifosfamide has occurred in the higher dose cohorts. One patient with
advanced mesothelioma continues to have stable disease following
15 cycles
of therapy with ZIO-201 as a single agent. The Company recently initiated
a phase I/II trial in advanced sarcoma at The University of Texas
M. D.
Anderson Cancer Center. The MDACC will be joined by additional centers
in
the U.S., Canada and Europe in the coming months. A phase II study
in
patients with advanced sarcoma utilizing a modified dosing regimen
in the
U.S. is expected to initiate in the first half of 2006 and plans
for a
phase I/II study in pediatric sarcoma are well advanced. The Company
expects to pursue registration in the U.S. for the treatment of advanced
sarcoma and a pivotal trial to begin in
2007.
|
· |
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
|
$
|
—
|
|
|
Page
|
Audited
Financial Statements of ZIOPHARM Oncology, Inc.:
|
|
|
Report
of Independent Registered Public Accounting Firm
|
|
F-1
|
Balance
Sheets as of December 31, 2005 and 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
|
S
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
|
Statements
of Changes in Convertible Preferred Stock and Stockholders’ Equity
(Deficit) for the Year Ended December 31, 2005 and 2004 and For the
Period
from Inception (September 9, 2003) through December 31,
2003
|
|
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 Period
|
For
the Period
|
|||||||||
For
the
|
Twelve
|
from
Inception
|
from
Inception
|
||||||||||
|
Twelve
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
|
)
|
(9516,923
|
)
|
|||||||||||||||
|
|||||||||||||||||||||||||
Balance
at December 31, 2005
|
-
|
$
|
-
|
$
|
-
|
7,248,115
|
$
|
7,248
|
$
|
22,559,034
|
$
|
(15,364,356
|
)
|
$
|
7,201,926
|
1. | ORGANIZATION |
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
|
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.
|
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.
|
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.
|
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
|
10.9
|
Form
of Employee Non-Qualified Stock Option Agreement granted under 2003
Stock
Option Plan
|
10.10
|
Form
of Director Non-Qualified Stock Option Agreement granted under 2003
Stock
Option Plan
|
23.1
|
Consent
of Independent Registered Public Accounting Firm - Vitale, Caturano
&
Company, Ltd.
|
31.1
|
Certification
of Chief Executive Officer pursuant to Securities Exchange Act Rule
13a-15(e)/15d-15(e) as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
31.2
|
Certification
of Chief Financial Officer pursuant to Securities Exchange Act Rule
13a-15(e)/15d-15(e) as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
32.1
|
Certification
of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as
adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
32.2
|
Certification
of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as
adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
ZIOPHARM ONCOLOGY, INC. | ||
|
|
|
Date: March 20, 2006 | By: | /s/ Jonathan Lewis |
Jonathan Lewis |
||
Chief
Executive Officer
(Principal Executive
Officer)
|
|
|
|
Date: March 20, 2006 | By: | /s/ Richard Bagley |
Richard Bagley |
||
President,
Chief
Financial Officer, Treasurer and Chief Operating Officer
(Principal
Financial and Accounting
Officer)
|
Signature
|
Title
|
Date
|
|
/s/ Jonathan Lewis | |||
Jonathan
Lewis
|
Director
and Chief Executive Officer (Principal Executive Officer)
|
March
20, 2006
|
|
/s/ Richard Bagley | |||
Richard
Bagley
|
Director,
President, Chief Financial Officer, Treasurer and Chief Operating
Officer
(Principal Accounting and Financial Officer)
|
March
20, 2006
|
|
Murray
Brennan
|
Director
|
March
20, 2006
|
|
/s/ James Cannon | |||
James
Cannon
|
Director
|
March
20, 2006
|
|
/s/ Timothy McInerney | |||
Timothy
McInerney
|
Director
|
March
20, 2006
|
|
Wyche
Fowler, Jr.
|
Director
|
March
20, 2006
|
|
/s/ Gary S. Fragin | |||
Gary
S. Fragin
|
Director
|
March
20, 2006
|
|
/s/ Michael Weiser | |||
Michael
Weiser
|
Director
|
March
20, 2006
|
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.
|
4.6
|
Form
of Option for the Purchase of Shares of Common Stock dated October
15,
2004 and issued to The University of Texas M.D. Anderson Cancer Center.
|
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.
|
10.1
|
2003
Stock Incentive Plan (incorporated by reference to Exhibit 10.1 to
the
Registrant’s Registration Statement on Form SB-2 (SEC File No. 333-129020)
filed October 14, 2005).
|
10.2
|
Employment
Agreement dated January 8, 2004, between the Registrant and Dr. Jonathan
Lewis (incorporated by reference to Exhibit 10.2 to the Registrant’s
Registration Statement on Form SB-2 (SEC File No. 333-129020) filed
October 14, 2005).
|
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
|
10.9
|
Form
of Employee Non-Qualified Stock Option Agreement granted under 2003
Stock
Option Plan
|
10.10
|
Form
of Director Non-Qualified Stock Option Agreement granted under 2003
Stock
Option Plan
|
23.1
|
Consent
of Independent Registered Public Accounting Firm - Vitale, Caturano
&
Company, Ltd.
|
31.1
|
Certification
of Chief Executive Officer pursuant to Securities Exchange Act Rule
13a-15(e)/15d-15(e) as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
31.2
|
Certification
of Chief Financial Officer pursuant to Securities Exchange Act Rule
13a-15(e)/15d-15(e) as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
32.1
|
Certification
of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as
adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
32.2
|
Certification
of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as
adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
No. DT-1 |
55,125
Shares
|
If to the Holder: |
DEKK-Tec,
Inc.
c/o
Lee Roy Morgan
725
Topaz Street
New
Orleans, LA 70124-3623
|
|
If to the Company: |
ZIOPHARM,
Inc.
1180
Avenue of the Americas, 19th
Floor
New
York, NY 10036
Attn:
Chief Executive Officer
|
ZIOPHARM,
INC.
|
||
|
|
|
By: | /s/ Richard E. Bagley | |
|
||
Name: | Richard E. Bagley | |
Title | President & Chief Operating Officer |
Date: ___________________________ | Signature: ________________________________________________ |
Address: ________________________________________________ |
Date: ___________________________ | Signature: ________________________________________________ |
Address: ________________________________________________ |
Date: ___________________________ | Signature: ________________________________________________ |
Address: ________________________________________________ |
Number
of Shares:
27,616
Exercise
Price:
$0.02/share
|
|
Vesting
Schedule:
|
|
No.
of Shares
|
Vesting
Date
|
6,904
|
October
15, 2004
|
6,904
|
Upon
the dosing of the first patient in the first Phase III clinical trial
of
Licensed Product in the United States under a Company or Company
sublicense sponsored IND
|
13,808
|
Upon
the final approval by the FDA of the first NDA submitted by the Company
or
its sublicensee for a Licensed
Product
|
No.
MDACC-_
|
_______ Shares
|
ZIOPHARM INC. | ||
|
|
|
Date: | By: | |
Name: Jonathan Lewis, M.D. |
||
Title: Chief Executive Officer | ||
ATTEST: | ||
David
M. Tanen
Secretary
|
Date:
|
_______________
|
Signature:
|
____________________
|
|
Address:
|
______________________
|
Date:
|
_______________
|
Signature:
|
____________________
|
|
Address:
|
______________________
|
Date:
|
_______________
|
Signature:
|
____________________
|
|
Address:
|
______________________
|
Option
No.
|
Shares
subject to Option
(post-merger)
|
Aggregate
Exercise
Price
|
Vesting
Date
|
MDACC-1
|
12,556
|
$500.00
|
Upon
the filing of an IND for any Licensed Product that is covered by
the
Patent Rights entitled “Arsenic-Lipid Derivatives as a Treatment for
Cancer” (MDA04-076) (as defined in that certain License Agreement entered
into by and among the Company and the Board of Regents of the University
of Texas Systems dated August 27, 2004)(the “Vesting Date”). Options
remain exercisable for five years from the Vesting
Date.
|
MDACC-2
|
25,111
|
$250.00
|
Upon
the date on which the Company completes the dosing of the last patient
for
both the blood and solid tumor Phase I clinical trials for the first
Licensed Product (as defined in that certain License Agreement entered
into by and among the Company and the Board of Regents of the University
of Texas Systems dated August 27, 2004)(the “Vesting Date”). Options
remain exercisable for five years from the Vesting
Date.
|
MDACC-3
|
12,555
|
$250.00
|
Upon
the date on which the first patient is enrolled in a multi-center
Pivotal
Study for a Licensed Product (as defined in that certain License
Agreement
entered into by and among the Company and the Board of Regents of
the
University of Texas Systems dated August 27, 2004)(the “Vesting Date”).
Options remain exercisable for five years from the Vesting
Date.
|
If
to the Company:
ZIOPHARM
Oncology, Inc.
1180
Avenue of the Americas, 19th
Floor
New
York, NY 10036
Attn:
Chief Executive Officer
|
If
to Employee:
______________________________
______________________________
______________________________
|
Number of Shares: |
|
EMPLOYEE:
|
|
Exercise
Price:
|
$ /share | Name: | |
ZIOPHARM
Oncology, INC.
|
|||
By: | |||
Its: |
Vesting
Schedule:
|
||
No.
of Shares To Be Vested
|
Vesting
Date
|
|
If
to the Company:
ZIOPHARM
Oncology, Inc.
1180
Avenue of the Americas, 19th
Floor
New
York, NY 10036
Attn:
Chief Executive Officer
|
If
to Employee:
________________________________
________________________________
________________________________
|
Number of Shares: |
|
EMPLOYEE:
|
|
Exercise
Price:
|
$ /share | Name: | |
ZIOPHARM
Oncology, INC.
|
|||
By: | |||
Its: |
Vesting
Schedule:
|
||
No.
of Shares To Be Vested
|
Vesting
Date
|
|
If
to the Company:
ZIOPHARM
Oncology, Inc.
1180
Avenue of the Americas, 19th
Floor
New
York, Yew York 10036
Attn:
Chief Executive Officer
|
If
to Director:
_________________________________________
_________________________________________
_________________________________________
|
Number of Shares: |
|
DIRECTOR:
|
|
Exercise
Price:
|
$ /share | Name: | |
ZIOPHARM
Oncology, INC.
|
|||
By: |
(1)
|
The
Report fully complies with the requirements of Section 13(a) or 15(d)
of
the Securities Exchange Act of 1934; and
|
|
(2)
|
The
information contained in the Report fairly presents, in all material
respects, the financial condition and result of operations of the
Company.
|
(1)
|
The
Report fully complies with the requirements of Section 13(a) or 15(d)
of
the Securities Exchange Act of 1934; and
|
|
(2)
|
The
information contained in the Report fairly presents, in all material
respects, the financial condition and result of operations of the
Company.
|