Delaware
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84-1475642
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(State
or jurisdiction
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(I.R.S.
Employer
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of
incorporation or organization)
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Identification
No.)
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Dr.
Jonathan Lewis
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Copies
to:
|
Chief
Executive Officer
|
Alan
M. Gilbert, Esq.
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ZIOPHARM
Oncology, Inc.
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Maslon
Edelman Borman & Brand, LLP
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1180
Avenue of the Americas, 19th Floor
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90
South 7th Street, Suite 3300
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New
York, NY 10036
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Minneapolis,
Minnesota 55402
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Telephone:
(646) 214-0700
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Telephone:
(612) 672-8200
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Facsimile:
(646) 214-0711
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Facsimile:
(612) 642-8381
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(Name,
address and telephone number of agent for service)
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Large
accelerated filer ¨
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Accelerated
filer ¨
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Non-accelerated
filer ¨
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Smaller
reporting company þ
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(Do
not check if a smaller reporting company)
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Title of Each Class of
Securities to be Registered
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Amount to be
Registered (1) (2)
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Proposed Maximum
Offering Price Per
Unit (3)
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Proposed Maximum
Aggregate
Offering Price (3)
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Amount of
Registration Fee (3)
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|||||
Common
stock, par value $.001 per share
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5,683,291 shares
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$1.89
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$10,741,419.99
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$599.37
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(1)
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There
is also being registered hereunder an indeterminate number of additional
shares of common stock as shall be issuable pursuant to Rule 416 to
prevent dilution resulting from stock splits, stock dividends or similar
transactions.
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(2)
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Includes
2,910,954 shares of common stock issuable upon the exercise of outstanding
warrants.
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(3)
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Estimated
solely for the purpose of calculating the registration fee in accordance
with Rule 457 of the Securities Act based upon a $1.89 per share average
of high and low prices of the registrant’s common stock on the Nasdaq
Capital Market on September 21,
2009.
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Page
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||
Prospectus
Summary
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1
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Risk
Factors
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5
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Cautionary
Note Regarding Forward Looking Statements
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17
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Use
of Proceeds
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17
|
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Selling
Stockholders
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18
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Plan
of Distribution
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21
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Disclosure
of Commission Position on Indemnification for Securities Act
Liabilities
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23
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About
This Prospectus
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23
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Where
You Can Find More Information
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24
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Incorporation
of Certain information by Reference
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24
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Validity
of Common Stock
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25
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Experts
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25
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·
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ZIO-101,
or darinaparsin (ZinaparTM),
is an anti-mitochondrial (organic arsenic) compound covered by issued
patents and pending patent applications in the U.S. and in foreign
countries. A form of commercially available inorganic arsenic
(arsenic trioxide [Trisenox ®]; “ATO”) has been approved in the United
States, the European Union, and Japan for the
treatment of acute promyelocytic leukemia (“APL”), a precancerous
condition. In the United States, ATO is on the compendia listing for the
therapy of multiple myeloma, and has been studied for the treatment of
various other cancers. Nevertheless, ATO has been shown to be
toxic to the heart, liver, and brain, which limits its use as an
anti-cancer agent. ATO carries a “black box” warning for ECG
abnormalities since arsenic trioxide has been shown to cause QT interval
prolongation and complete atrioventricular block. QT
prolongation can lead to a torsade de pointes-type ventricular arrhythmia,
which can be fatal. Inorganic arsenic has also been shown to
cause cancer of the skin and lung in humans. The toxicity of
arsenic is generally correlated to its accumulation in organs and
tissues. Our preclinical and clinical studies to date have
demonstrated that darinaparsin is considerably less toxic than inorganic
arsenic, particularly with regard to cardiac toxicity. In vitro testing of
darinaparsin using the National Cancer Institute’s human cancer cell panel
demonstrated activity against a series of tumor cell lines including lung,
colon, brain, melanoma, ovarian, and kidney cancer. Moderate
activity was shown against breast and prostate cancer tumor cell
lines. 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. Results indicate significant activity against the HuT
78 cutaneous T-cell lymphoma, the NK-G2MI natural killer-cell NHL,
KARPAS-299 T-cell NHL, SU-DHL-8 B-cell NHL, SU-DHL-10 B-cell NHL and
SU-DHL-16 B-cell NHL cell lines. Preclinical studies have also established
anti-angiogenic properties of darinaparsin and provided support for the
development of an oral capsule form of the drug, and established synergy
of darinaparsin in combination with other approved anti-cancer
agents.
|
|
·
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ZIO-201,
or palifosfamide (ZymafosTM),
is the active metabolite of ifosfamide, a compound chemically related to
cyclophosphamide and bendamustine. Patent applications covering
proprietary forms of palifosfamide for pharmaceutical composition and
method of use have been filed in the U.S. and
internationally. Like cyclophosphamide, ifosfamide and
bendamustine, palifosfamide is a DNA alkylating agent, a form of cancer
therapy to treat a wide range of solid tumors and hematological
malignancies. The Company believes that cyclophosphamide is the
most widely used alkylating agent in cancer therapy, with significant use
in the treatment of breast cancer and non-Hodgkin’s lymphoma. Bendamustine
has been recently approved and successfully launched by Cephalon in the
U.S. and Europe to treat certain hematological
malignancies Ifosfamide has been shown to be effective at
high doses in the treatment of sarcoma and lymphoma, either by itself or
in combination with other anticancer agents. Ifosfamide is
approved by the U.S. Food and Drug Administration as a
treatment for testicular cancer while ifosfamide-based treatment is a
standard of care for sarcoma, although it is not licensed for this
indication by the FDA. Preclinical studies have shown that
palifosfamide has activity against leukemia and solid
tumors. These studies also indicate that palifosfamide may have
a better safety profile than ifosfamide or cyclophosphamide because it
does not appear to produce known toxic metabolites of ifosfamide, such as
acrolein and chloroacetaldehyde. Acrolein, which is toxic to
the kidneys and bladder, can mandate the administration of a protective
agent called mesna, which is inconvenient and
expensive. Chloroacetaldehyde 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. Palifosfamide has evidenced activity against
ifosfamide- and/or cyclophosphamide-resistant cancer cell
lines. Also in preclinical cancer models, palifosfamide was
shown to be orally active and encouraging results have been obtained with
palifosfamide in combination with doxorubicin, an agent approved to treat
sarcoma.
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·
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ZIO-301,
or indibulin (ZybulinTM),
is a novel, orally available small molecular-weight inhibitor of tubulin
polymerization that was acquired from Baxter Healthcare and is the subject
of numerous patents worldwide, including the United States, the European
Union and Japan. The microtubule component, tubulin, is one of
the more well established drug targets in cancer. Microtubule
inhibitors interfere with the dynamics of tubulin polymerization,
resulting in inhibition of chromosome segregation during mitosis and
consequently inhibition of cell division. A number of marketed
IV anticancer drugs target tubulin, such as the taxane family members,
paclitaxel (Taxol®), docetaxel (Taxotere®) , the Vinca alkaloid family
members, vincristine and vinorelbine, and the new class of epothilones
with IxempraTM marketed. This class of agents is typically the
mainstay of therapy in a wide variety of indications. In spite of their
effectiveness, the use of these drugs is associated with significant
toxicities, notably peripheral
neurotoxicity.
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Common
stock covered hereby
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5,683,291
shares
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Common
stock outstanding before the offering (1)
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25,571,301
shares
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Common
stock outstanding after the offering (2)
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28,482,255
shares
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Common
Stock Nasdaq Capital Market symbol
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ZIOP
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(1)
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Based
on the number of shares outstanding as of September 24, 2009, not
including 11,171,529 shares issuable upon exercise of various warrants and
options to purchase common stock.
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(2)
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Assumes
the issuance of all shares covered hereby that are issuable upon exercise
of outstanding warrants.
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·
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continue
to undertake clinical trials for product
candidates;
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·
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scale-up
the formulation and manufacturing of our product
candidates;
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·
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seek
regulatory approvals for product
candidates;
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·
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implement
additional internal systems and infrastructure;
and
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·
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hire
additional personnel.
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·
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Continuing to undertake
preclinical development and clinical
trials;
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·
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Participating in regulatory
approval processes;
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·
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Formulating and manufacturing
products; and
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·
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Conducting sales and marketing
activities.
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·
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decreased
demand for our product candidates;
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·
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injury
to our reputation;
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·
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withdrawal
of clinical trial participants;
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·
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withdrawal
of prior governmental approvals;
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·
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costs
of related litigation;
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·
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substantial
monetary awards to patients;
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·
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product
recalls;
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·
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loss
of revenue; and
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·
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the
inability to commercialize our product
candidates.
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·
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delay
commercialization of, and our ability to derive product revenues from, our
product candidates;
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·
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impose
costly procedures on us; and
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·
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diminish
any competitive advantages that we may otherwise
enjoy.
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·
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unforeseen
safety issues;
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·
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determination
of dosing issues;
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·
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lack
of effectiveness during clinical
trials;
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·
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slower
than expected rates of patient
recruitment;
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·
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inability
to monitor patients adequately during or after treatment;
and
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·
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inability
or unwillingness of medical investigators to follow our clinical
protocols.
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·
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perceptions
by members of the health care community, including physicians, regarding
the safety and effectiveness of our
drugs;
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·
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cost-effectiveness
of our products relative to competing
products;
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|
·
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availability
of reimbursement for our products from government or other healthcare
payers; and
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·
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effectiveness
of marketing and distribution efforts by us and our licensees and
distributors, if any.
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·
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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.
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·
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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.
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·
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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.
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·
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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.
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·
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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.
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·
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developing
drugs;
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·
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undertaking
preclinical testing and human clinical
trials;
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·
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obtaining
FDA and other regulatory approvals of
drugs;
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·
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formulating
and manufacturing drugs; and
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·
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launching,
marketing, and selling drugs.
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·
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perceptions
by members of the health care community, including physicians, about the
safety and effectiveness of our
drugs;
|
|
·
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pharmacological
benefit and cost-effectiveness of our products relative to competing
products;
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·
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availability
of reimbursement for our products from government or other healthcare
payors;
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·
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effectiveness
of marketing and distribution efforts by us and our licensees and
distributors, if any; and
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·
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the
price at which we sell our
products.
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·
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government
and health administration
authorities;
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·
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private
health maintenance organizations and health insurers;
and
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·
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other
healthcare payers.
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·
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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;
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·
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if
and when patents will be issued;
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·
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whether
or not others will obtain patents claiming aspects similar to those
covered by our patents and patent applications;
or
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|
·
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whether
we will need to initiate litigation or administrative proceedings that may
be costly whether we win or lose.
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Selling Stockholder
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Shares
Beneficially
Owned Before
Offering (1)
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Total Shares
Offered
By Selling
Stockholder (2)
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Shares
Beneficially
Owned After
Offering (3)
|
Percentage of
Beneficial
Ownership
After
Offering (3)
|
||||||||||||
Brookline
Ziopharm Investment Fund, LLC (4)
|
1,863,012 | (5) | 1,863,012 | 0 | 0 | % | ||||||||||
Hartwell
Davis Jr.
|
328,766 | (6) | 328,766 | 0 | 0 | % | ||||||||||
DAFNA
LifeScience Ltd (7)
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47,000 | (8) | 47,000 | 0 | 0 | % | ||||||||||
DAFNA
LifeScience Market Neutral Ltd (7)
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39,600 | (9) | 39,600 | 0 | 0 | % | ||||||||||
DAFNA
LifeScience Select Ltd (7)
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187,374 | (10) | 187,374 | 0 | 0 | % | ||||||||||
Placifor
Investments Corp. (11)
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547,944 | (12) | 547,944 | 0 | 0 | % | ||||||||||
Timothy
McInerney (13)
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396,703 | (14) | 140,298 | 256,405 | 1.00 | % | ||||||||||
Essex
Woodlands Health Ventures Fund VI, L.P. (15)
|
2,954,184 | (16) | 657,532 | 2,296,652 | 8.85 | % | ||||||||||
Special
Situations Life Sciences Fund, L.P. (17)
|
932,671 | (18) | 547,946 | 384,725 | 1.50 | % | ||||||||||
Joia
and Joshua Kazam
|
79,036 | (19) | 54,794 | 24,242 | * | |||||||||||
Domaco
Venture Capital Fund (20)
|
27,400 | (21) | 27,400 | 0 | 0 | % | ||||||||||
Anthony
G. Polak
|
27,400 | (22) | 27,400 | 0 | 0 | % | ||||||||||
Anthony
G. Polak "S"
|
27,400 | (23) | 27,400 | 0 | 0 | % | ||||||||||
Jamie
Polak
|
27,400 | (24) | 27,400 | 0 | 0 | % | ||||||||||
Emily
L. Polak
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27,400 | (25) | 27,400 | 0 | 0 | % | ||||||||||
IRA
FBO Ronald M. Lazar, DTD 09/84, Pershing LLC as custodian
(26)
|
27,400 | (27) | 27,400 | 0 | 0 | % | ||||||||||
RL
Capital Partners (26)
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109,600 | (28) | 109,600 | 0 | 0 | % | ||||||||||
Far
Ventures, LLC (29)
|
30,019 | (30) | 20,000 | 10,019 | * | |||||||||||
Ralph
Finerman
|
21,916 | (31) | 21,916 | 0 | 0 | % | ||||||||||
Cynthia
K. Finerman
|
10,958 | (32) | 10,958 | 0 | 0 | % | ||||||||||
AAR
Associates, L.P. (33)
|
21,916 | (34) | 21,916 | 0 | 0 | % | ||||||||||
Hill
Blalock, Jr.
|
132,683 | (35) | 109,588 | 23,095 | * | |||||||||||
Cranshire
Capital LP (36)
|
273,972 | (37) | 273,972 | 0 | 0 | % | ||||||||||
GCA
Strategic Investment Fund Limited (38)
|
273,972 | (39) | 273,972 | 0 | 0 | % | ||||||||||
Kingsbrook
Opportunities Master Fund LP (40)
|
109,590 | (41) | 109,590 | 0 | 0 | % | ||||||||||
Harold
J. Meyers TTEE Harold J. & Paula P. Meyers Family Trust DTD 6/16/78
(42)
|
54,794 | (43) | 54,794 | 0 | 0 | % | ||||||||||
Rodman
& Renshaw, LLC (44)
|
53,992 | (45) | 53,992 | 0 | 0 | % | ||||||||||
Noel
Brown
|
5,267 | (46) | 5,267 | 0 | 0 | % | ||||||||||
Jainal
Bhuiyan
|
3,292 | (47) | 3,292 | 0 | 0 | % | ||||||||||
Noam
Rubinstein
|
3,292 | (48) | 3,292 | 0 | 0 | % | ||||||||||
Riverbank
Capital Securities, Inc. (49)
|
23,045 | (50) | 23,045 | 0 | 0 | % | ||||||||||
Scott
L. Navins
|
2,500 | (51) | 2,500 | 0 | 0 | % | ||||||||||
Griffin
Securities, Inc. (52)
|
145,908 | (53) | 6,931 | 138,977 | * |
*
|
Less
than 1%.
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(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.
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(2)
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Includes
outstanding shares of common stock and shares of common stock issuable
upon the exercise of warrants held by the selling
stockholder.
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(3)
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Assumes
sales of all shares offered under this prospectus by the selling
stockholder.
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(4)
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Madding
King has voting and investment control over the shares held by the selling
stockholder.
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(5)
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Includes
931,506 shares issuable upon the exercise of
warrants.
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(6)
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Includes
164,383 shares issuable upon the exercise of
warrants.
|
(7)
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Dr.
Nathan Fischel has voting and investment control over the shares held by
the selling stockholder.
|
(8)
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Includes
23,500 shares issuable upon the exercise of
warrants.
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(9)
|
Includes
19,800 shares issuable upon the exercise of
warrants.
|
(10)
|
Includes
93,687 shares issuable upon the exercise of
warrants.
|
(11)
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Stephen
Robert Beidson, as director of the selling stockholder, has voting and
investment control over the shares held by the selling
stockholder.
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(12)
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Includes
273,972 shares issuable upon the exercise of
warrants.
|
(13)
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Mr.
McInereney serves as a member of the Company’s Board of
Directors.
|
(14)
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Includes
238,498 shares issuable upon the exercise of warrants and options to
purchase common stock.
|
(15)
|
R.
Scott Barry, as a managing director of the selling stockholder, has voting
and investment control over the shares held by the selling stockholder.
Mr. Barry disclaim beneficial ownership of such
shares.
|
(16)
|
Includes
711,542 shares issuable upon the exercise of
warrants.
|
(17)
|
AWM
Investment Company, Inc. (“AWM”) is the investment adviser to the Special
Situations Life Sciences Fund, L.P. (the "Life Sciences
Fund"). Austin W. Marxe and David M. Greenhouse are the
principal owners of AWM. Through their control of AWM, Messrs.
Marxe and Greenhouse share voting and investment control over the
portfolio securities of the Life Sciences
Fund.
|
(18)
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Includes
350,528 shares issuable upon the exercise of
warrants.
|
(19)
|
Includes
27,397 shares issuable upon the exercise of
warrants.
|
(20)
|
Jack
Polak has voting and investment control over the shares held by the
selling stockholder.
|
(21)
|
Includes
13,700 shares issuable upon the exercise of
warrants.
|
(22)
|
Includes
13,700 shares issuable upon the exercise of
warrants.
|
(23)
|
Includes
13,700 shares issuable upon the exercise of
warrants.
|
(24)
|
Includes
13,700 shares issuable upon the exercise of
warrants.
|
(25)
|
Includes
13,700 shares issuable upon the exercise of
warrants.
|
(26)
|
Ronald
Lazar has voting and investment control over the shares held by the
selling stockholder.
|
(27)
|
Includes
13,700 shares issuable upon the exercise of
warrants.
|
(28)
|
Includes
54,800 shares issuable upon the exercise of
warrants.
|
(29)
|
Steven
M. Farber and S. Edmond Farber each has voting and investment control over
the shares held by the selling
stockholder.
|
(30)
|
Includes
10,000 shares issuable upon the exercise of
warrants.
|
(31)
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Includes
10,958 shares issuable upon the exercise of
warrants.
|
(32)
|
Includes
5,479 shares issuable upon the exercise of
warrants.
|
(33)
|
Ralph
Finerman has voting and investment control over the shares held
by the selling stockholder..
|
(34)
|
Includes
10,958 shares issuable upon the exercise of
warrants.
|
(35)
|
Includes
54,794 shares issuable upon the exercise of
warrants.
|
(36)
|
Downsview
Capital, Inc. (“Downsview”) is the general partner of Cranshire Capital,
L.P. (“Cranshire”) and consequently has voting control and investment
discretion over securities held by Cranshire. Mitchell P. Kopin
(“Mr. Kopin”), President of Downsview, has voting control over
Downsview. As a result of the foregoing, each of Mr. Kopin and
Downsview may be deemed to have beneficial ownership (as determined under
Section 13(d) of the Securities Exchange Act of 1934, as amended) of the
shares of common stock beneficially owned by
Cranshire.
|
(37)
|
Includes
136,986 shares issuable upon the exercise of
warrants.
|
(38)
|
Lewis
N. Lester Sr., as Director the selling stockholder, has voting and
investment control over the shares held by the selling
stockholder.
|
(39)
|
Includes
136,986 shares issuable upon the exercise of
warrants.
|
(40)
|
Kingsbrook
Partners LP (“Kingsbrook Partners”) is the investment manager of
Kingsbrook Opportunities Master Fund LP (“Kingsbrook Opportunities”) and
consequently has voting control and investment discretion over securities
held by Kingsbrook Opportunities. Kingsbrook
Opportunities GP LLC (“Opportunities GP”) is the general partner of
Kingsbrook Opportunities and may be considered the beneficial owner of any
securities deemed to be beneficially owned by Kingsbrook
Opportunities. KB GP LLC (“GP LLC”) is the general partner of
Kingsbrook Partners and may be considered the beneficial owner of any
securities deemed to be beneficially owned by Kingsbrook
Partners. Ari J. Storch, Adam J. Chill and Scott M.
Wallace are the sole managing members of Opportunities GP and GP LLC and
as a result may be considered beneficial owners of any securities deemed
beneficially owned by Opportunities GP and GP LLC. Each
of Kingsbrook Partners, Opportunities GP, GP LLC and Messrs. Storch, Chill
and Wallace disclaim beneficial ownership of these
securities.
|
(41)
|
Includes
54,795 shares issuable upon the exercise of
warrants.
|
(42)
|
Harold
J. Meyers, as Trustee of the selling stockholders, has voting and
investment control over the shares held by the selling
stockholder.
|
(43)
|
Includes
27,397 shares issuable upon the exercise of
warrants.
|
(44)
|
John
Bover, as Senior Managing Director of the selling stockholder, has voting
and investment control over the shares held by the selling
stockholder.
|
(45)
|
Includes
53,992 shares issuable upon the exercise of
warrants.
|
(46)
|
Includes
5,267 shares issuable upon the exercise of
warrants.
|
(47)
|
Includes
3,292 shares issuable upon the exercise of
warrants.
|
(48)
|
Includes
3,292 shares issuable upon the exercise of
warrants.
|
(49)
|
David
M. Tanen, Joshua A. Kazam and Peter M. Kash each has voting and investment
control over the shares held by the selling
stockholder.
|
(50)
|
Includes
23,045 shares issuable upon the exercise of
warrants.
|
(51)
|
Includes
2,500 shares issuable upon the exercise of
warrants.
|
(52)
|
Adrian
Stecyk has voting and investment control over the shares held by the
selling stockholder.
|
(53)
|
Includes
145,908 shares issuable upon the exercise of
warrants.
|
|
·
|
on
any national securities exchange or quotation service on which the
securities may be listed or quoted at the time of
sale;
|
|
·
|
in
the over-the-counter market;
|
|
·
|
in
transactions otherwise than on these exchanges or systems or in the
over-the-counter market;
|
|
·
|
through
the writing of options, whether such options are listed on an options
exchange or otherwise;
|
|
·
|
ordinary
brokerage transactions and transactions in which the broker-dealer
solicits purchasers;
|
|
·
|
block
trades in which the broker-dealer will attempt to sell the shares as agent
but may position and resell a portion of the block as principal to
facilitate the transaction;
|
|
·
|
purchases
by a broker-dealer as principal and resale by the broker-dealer for its
account;
|
|
·
|
an
exchange distribution in accordance with the rules of the applicable
exchange;
|
|
·
|
privately
negotiated transactions;
|
|
·
|
settlement
of short sales entered into after the effective date of the registration
statement of which this prospectus is a
part;
|
|
·
|
broker-dealers
may agree with the selling securityholders 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.
|
|
·
|
Annual
Report on Form 10-K for the fiscal year ended December 31, 2008,
filed on March 23, 2009;
|
|
·
|
Quarterly
Reports on Form 10-Q for the quarters ended March 31 and June 30, 2009,
filed on May 15 and August 14, 2009,
respectively;
|
|
·
|
Current
Reports on Form 8-K filed on each of June 1, 2009, June 4, and September
15, 2009; and
|
|
·
|
The
description of our common stock set forth in the registration statement on
Form 8-A registering our common stock under Section 12 of the Exchange
Act, which was filed with the SEC on September 20,
2006.
|
SEC
registration fee
|
$ | 599 | ||
Legal
fees and expenses
|
10,000 | |||
Accounting
fees and expenses
|
10,000 | |||
Printing
and engraving expenses
|
3,000 | |||
Miscellaneous
|
2,000 | |||
$ | 25,599 |
Item
15.
|
Indemnification
of Directors and Officers.
|
Exhibit No.
|
Description
|
|
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).
|
|
4.1
|
Amended
and Restated Certificate of Incorporation, as filed with the Delaware
Secretary of State on April 26, 2006 (incorporated by reference to Exhibit
3.1 to the registrant’s Current Report of Form 8-K filed April 26,
2006).
|
|
4.2
|
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).
|
|
4.3
|
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).
|
|
4.4
|
Bylaws,
as amended to date (incorporated by reference to Exhibit 3.3 to the
registrant’s Form 8-K filed September 19, 2005).
|
|
4.5
|
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).
|
|
4.6
|
Form
of Warrant to Purchase Common Stock issued to investors in the September
2009 private placement (incorporated by reference to Exhibit 4.1 to the
registrant’s Current Report on Form 8-K filed September 15,
2009).
|
|
4.7
|
|
Form
of Warrant to Purchase Common Stock issued to placement agents in the
September 2009 private placement (incorporated by reference to Exhibit 4.2
to the registrant’s Current Report on Form 8-K filed September 15,
2009).
|
4.8
|
Securities
Purchase Agreement between the registrant and each of the Purchasers
identified therein, dated September 9, 2009 (incorporated by reference to
Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed
September 15, 2009).
|
|
4.9
|
Registration
Rights Agreement between the registrant and each of the Holders identified
therein, dated September 9, 2009 (incorporated by reference to Exhibit
10.2 to the registrant’s Current Report on Form 8-K filed September 15,
2009).
|
|
5.1
|
Legal
opinion of Maslon Edelman Borman & Brand, LLP (filed
herewith).
|
|
23.1
|
Consent
of Independent Registered Public Accounting Firm - Caturano and Company,
P.C. (filed
herewith).
|
|
23.2
|
Consent
of Maslon Edelman Borman & Brand, LLP (included as part of Exhibit
5.1).
|
|
24.1
|
|
Power
of Attorney (included on signature page to this Registration
Statement).
|
Item
17.
|
Undertakings.
|
ZIOPHARM
Oncology, Inc.
|
||
By:
|
/s/ Jonathan
Lewis
|
|
Jonathan
Lewis
|
||
Chief
Executive Officer
|
Name
|
Title
|
Date
|
||
/s/ Jonathan Lewis
|
Director
and Chief Executive Officer
|
September 28,
2009
|
||
Jonathan Lewis
|
(Principal
Executive Officer)
|
|||
/s/ Richard E. Bagley
|
Director,
President, Treasurer and Chief
|
September 28,
2009
|
||
Richard E. Bagley
|
Operating
Officer (Principal Accounting
|
|||
and
Financial Officer)
|
||||
/s/ Murray Brennan
|
Director
|
September 28,
2009
|
||
Murray Brennan
|
||||
/s/ James Cannon
|
Director
|
September 28,
2009
|
||
James Cannon
|
||||
/s/ Timothy McInerney
|
Director
|
September 28,
2009
|
||
Timothy McInerney
|
||||
/s/ Wyche Fowler, Jr.
|
Director
|
September 28,
2009
|
||
Wyche Fowler, Jr.
|
||||
/s/ Gary S. Fragin
|
Director
|
September 28,
2009
|
||
Gary S. Fragin
|
||||
/s/ Michael Weiser
|
|
Director
|
|
September 28,
2009
|
Michael Weiser
|
Exhibit No.
|
Description
|
|
5.1
|
Legal
opinion of Maslon Edelman Borman & Brand, LLP.
|
|
23.1
|
Consent
of Independent Registered Public Accounting Firm - Caturano and Company,
P.C.
|
|
23.2
|
Consent
of Maslon Edelman Borman & Brand, LLP (included as part of Exhibit
5.1).
|
|
24.1
|
|
Power
of Attorney (included on signature page to this Registration
Statement).
|
1. The Shares have been duly
authorized and are validly issued, fully paid and nonassessable;
and
|
2. The Warrant Shares have been duly
authorized and, when issued against payment of the requisite exercise
price under the respective Warrants, will be validly issued, fully paid
and nonassessable.
|
Very
truly yours,
|
||
/s/
Maslon Edelman Borman & Brand,
LLP
|