t
PROSPECTUS
SUPPLEMENT
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Filed
Pursuant to Rule 424(b)(5)
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(To
Prospectus dated September 21, 2009)
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File
No. 333-161453
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ZIOPHARM
Oncology, Inc.
15,484,000
Shares
Warrants
to Purchase 8,206,520 Shares
Common
Stock
We are
offering 15,484,000 shares of our common stock, par value $0.001 per share,
and warrants to purchase up to 7,742,000 shares of our common stock
pursuant to this prospectus supplement and the accompanying
prospectus. The common stock and warrants will be sold in units, with
each unit consisting of one share of common stock and a warrant to purchase 0.50
of a share of our common stock at an exercise price of $4.02 per
share. Each unit will be sold at a purchase price of
$3.10. Units will not be issued or certificated. The shares of common
stock and warrants are immediately separable and will be issued
separately. We are also issuing warrants to purchase up to an
aggregate of 464,520 shares of our common stock at an exercise price of
$4.02 per share to the underwriters as underwriting
compensation. See “Underwriting” beginning on page S-12
of this prospectus supplement for more information regarding these
arrangements.
Our
common stock is listed on the NASDAQ Capital Market under the symbol “ZIOP.” On
December 3, 2009, the last reported sale price of our common stock on the NASDAQ
Capital Market was $3.66 per share. There is no established public
trading market for the offered warrants and we do not expect a market to
develop. In addition, we do not intend to apply for listing of the warrants on
any national securities exchange.
Investing
in our securities involves risks. See “Risk Factors” beginning on
page S-7 of this prospectus supplement.
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Per
Unit
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|
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Total
|
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Public
offering price
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|
$ |
3.1000 |
|
|
$ |
48,000,400.00 |
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Underwriting
discounts and commissions
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$ |
0.1674 |
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$ |
2,592,021.60 |
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Proceeds,
before expenses, to us
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$ |
2.9326 |
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$ |
45,408,378.40 |
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Delivery
of the shares of the securities offered hereby is expected to be made on or
about December 9, 2009.
Neither
the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined if this prospectus
supplement or the accompanying prospectus is truthful or complete. Any
representation to the contrary is a criminal offense.
JMP
Securities
|
Rodman
& Renshaw, LLC
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The date
of this prospectus supplement is December 4, 2009.
TABLE
OF CONTENTS
Prospectus
Supplement
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Page
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About
This Prospectus
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S-1
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Prospectus
Supplement Summary
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S-2
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Risk
Factors
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S-7
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Special
Note Regarding Forward-Looking Statements
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S-8
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Use
of Proceeds
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S-8
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Dilution
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S-9
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Description
of Securities We are Offering
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S-10
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Underwriting
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S-12
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Where
You Can Find More Information
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S-14
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Incorporation
of Certain Information by Reference
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S-14
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Legal
Matters
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S-15
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Experts
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S-15
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Prospectus
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Page
|
About
This Prospectus
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i
|
Prospectus
Summary
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1
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Risk
Factors
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4
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Special
Note Regarding Forward-Looking Statements
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4
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Ratio
of Earnings to Fixed Charges
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5
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Use
of Proceeds
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5
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Plan
of Distribution
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5
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Description
of Capital Stock
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6
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Description
of Warrants
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14
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Certain
Provisions of Delaware Law, the Certificate of Incorporation and
Bylaws
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16
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Where
You Can Find More Information
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17
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Incorporation
of Certain Information by Reference
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18
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Legal
Matters
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18
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Experts
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18
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ABOUT
THIS PROSPECTUS
This
prospectus supplement is part of a registration statement that we filed with the
Securities and Exchange Commission (the “SEC”), using a “shelf” registration
process. This document has two parts. The first part is the prospectus
supplement, which describes the specific terms of the offering. The second part
is the accompanying prospectus, which describes more general information, some
of which may not apply to the offering. You should read both this prospectus
supplement and the accompanying prospectus, together with the additional
information described under the heading “Where You Can Find More
Information.”
You
should rely only on the information contained or incorporated by reference in
this prospectus supplement, in the accompanying prospectus, in any other
prospectus supplement and in any free writing prospectus filed by us with the
SEC. We have not, and the underwriters have not, authorized any other person to
provide you with different information. If anyone provides you with different or
inconsistent information, you should not rely on it. We are not, and the
underwriters are not, making an offer to sell these securities in any
jurisdiction where the offer or sale is not permitted. You should assume that
the information appearing in this prospectus supplement, the accompanying
prospectus and the documents incorporated by reference is accurate only as of
each of their respective dates. Our business, financial condition, results of
operations and prospects may have changed since those dates. To extent that any
statement that we make in this prospectus supplement differs from or is
inconsistent with statements made in the accompanying prospectus or any
documents incorporated by reference therein, the statements made in this
prospectus supplement will be deemed to modify or supersede those made in the
accompanying prospectus and such documents incorporated by reference
therein.
Unless
the context otherwise requires, references in this prospectus supplement to
“ZIOPHARM Oncology,” “ZIOPHARM,” “we,” “us,” and “our” refer to ZIOPHARM
Oncology, Inc.
This
prospectus supplement, the accompanying prospectus, and the information
incorporated herein and therein by reference includes trademarks, service marks
and trade names owned by us or other companies. All trademarks, service marks
and trade names included or incorporated by reference into this prospectus
supplement or the accompanying prospectus are the property of their respective
owners.
PROSPECTUS
SUPPLEMENT SUMMARY
This
summary highlights certain information about us, this offering and information
appearing elsewhere in this prospectus supplement, in the accompanying
prospectus and in the documents we incorporate by reference. This summary is not
complete and does not contain all of the information that you should consider
before investing in our securities. You should read this entire prospectus
supplement and the accompanying prospectus carefully, including the information
referred to under the heading “Risk Factors” in this prospectus supplement
beginning on page S-7, and the risk factors and the financial statements and
other information contained in our filings with the SEC which have been
incorporated by reference in this prospectus supplement and the accompanying
prospectus, when making an investment decision.
Our
Company
ZIOPHARM
Oncology, Inc. is a biopharmaceutical company that is seeking to develop and
commercialize a diverse, risk-sensitive portfolio of in-licensed cancer drugs
that can address unmet medical needs through enhanced efficacy and/or safety and
quality of life. Our principal focus is on the licensing and development of
proprietary small molecule drug candidates that are related to cancer
therapeutics already on the market or in development and can be administered by
intravenous (“IV”) and/or oral capsule forms. We believe this
strategy will result in lower risk and expedited drug development programs with
product candidates having a low cost of manufacturing to address changing
reimbursement requirements around the world. While we may
commercialize our products on our own in North America, we recognize that
favorable clinical trial results can be better addressed by partnering with
companies with the requisite financial resources and commercialization
bandwidth. The Company could also negotiate the right to complete
development and to enter into commercialization arrangements in certain other
geographies. Our three product candidates are darinaparsin (ZinaparTM,
ZIO-101), palifosfamide (ZymafosTM,
ZIO-201), and indibulin (ZybulinTM,
ZIO-301), with both darinaparsin and palifosfamide having completed phase
II clinical trials in refractory hematological malignancies
and advanced sarcoma, respectively, and with favorable interim results
also reported on the palifosfamide randomized phase II trial (PICASSO) in the
front- and second-line setting of soft tissue sarcoma (STS). The
interim results were subsequently reported at the Connective Tissue Oncology
Society’s (CTOS) annual meeting after enrollment in the PICASSO trial was
terminated early at 67 patients. The Company’s focus had been on
completing enrollment in the palifosfamide randomized Phase II trial in support
of a planned registration trial for palifosfamide in combination with
doxorubicin versus doxorubicin alone in the front- and second-line setting of
STS. We anticipate the initiation of such a trial as early as the
first half of 2010. Our more recent focus includes
having requested an end of Phase II meeting with the U.S. Food and
Drug Administration (FDA) not only for palifosfamide but also for darinaparsin,
the latter with regard to a potential registration trial in the first half of
2010 of darinaparsin in combination with CHOP versus CHOP alone in the
front-line setting of peripheral T-cell lymphoma, while at the same time
progressing with the initiation of the indibulin Phase I portion of a Phase I-II
trial in breast cancer involving a dosing schedule developed preclinically by
the Company’s consultant Dr. Larry Norton, also expected in the first half of
2010.
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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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Phase I
testing of the intravenous (IV) form of darinaparsin in solid tumors and
hematological cancers has been completed. The Company reported
clinical activity and, importantly, a safety profile from these studies as
predicted by preclinical results. The Company subsequently completed
Phase II studies in advanced myeloma and primary liver cancer and is nearing
completion of a Phase II study in certain other hematological
cancers. In addition, the Company is completing two Phase I studies
with an oral capsule form of darinaparsin. At the May 2009 annual
meeting of the American Society of Clinical Oncology (“ASCO”), the Company
reported favorable results from the trial with IV-administered darinaparsin in
lymphoma, particularly peripheral T-cell lymphoma (“PTCL”). In the
ongoing Phase I trials, also reported at the ASCO annual meeting, preliminary
data primarily in solid tumors indicate the oral form is active and well
tolerated. The Company is presently initiating data collection for
completing the IV Phase II trial with intention of meeting with the U.S. Food
and Drug Administration (“FDA”) to progress the IV program into a potentially
pivotal trial in PTCL as early as the first half of 2010. The Company
intends to fund that trial most likely from potential partnering and
other third party arrangements. We expect that the oral Phase I
program will continue to completion with establishment of a maximum
tolerated dose (“MTD”).
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ZIO-201,
or palifosfamide (ZymafosTM),
is the active metabolite of ifosfamide, a compound chemically related to
cyclophosphamide. 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 FDA 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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Following
Phase I study, Phase II testing of the intravenous form of palifosfamide as a
single agent to treat advanced sarcoma has been completed. In both
Phase I and Phase II testing, palifosfamide has been administered without the
“uroprotectant” mesna, and the toxicities associated with acrolein and
chloroacetaldehyde have not been observed. The Company reported
clinical activity of palifosfamide when used alone in the Phase II study
addressing advanced sarcoma. Following review of the preclinical
combination studies, clinical data, and discussion with sarcoma experts, the
Company initiated a Phase I dose escalation study of palifosfamide in
combination with doxorubicin in patients with metastatic or unresectable soft
tissue sarcoma. The Company reported favorable results and safety
profile from this study at this year’s ASCO annual meeting. In light
of reported favorable Phase II clinical activity data and with the combination
of palifosfamide with doxorubicin well tolerated in the Phase I trial and
evidencing activity, the Company initiated a Phase II randomized controlled
trial in the second half of last year to compare doxorubicin plus palifosfamide
to doxorubicin alone in patients with front and second-line metastatic or
unresectable soft tissue sarcoma. With regard to an interim
analysis of this trial and as a result of reaching a pre-specified efficacy
milestone and following safety and efficacy data review by the Data Committee,
sarcoma experts, and the Company’s Medical Advisory Board, the decision was
reached to formally stop enrollment in the trial on October 13,
2009. Subsequently, further positive interim data from the trial was
presented at the 15th Annual Connective Tissue Oncology Society (“CTOS”) meeting
held on November 6, 2009. The Company plans to initiate a
registration trial following and end of phase II meeting with FDA and further
regulatory review of the palifosfamide program to date. The Company
is also developing an oral capsule form of palifosfamide to be studied
clinically following further data from the IV trials and subject to partnering
or the availability of other sources of funding. The Company is also
considering additional Phase II trials in other solid tumors as funding becomes
available. Orphan Drug Designation for palifosfamide has been
obtained in both the United States and the European Union for the treatment of
soft tissue sarcomas.
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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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Preclinical
studies with indibulin demonstrate significant and broad antitumor activity,
including activity against taxane-refractory cell lines. The
cytotoxic activity of indibulin was demonstrated in several rodent and human
tumor cell lines derived from prostate, brain, breast, pancreas, lung, ovary,
and cervical tumor tissues and in rodent tumor and human tumor xenograft
models. In addition, indibulin was effective against multidrug
resistant tumor cell lines (breast, lung, and leukemia) both in vitro and in
vivo. Indibulin is potentially safer than other tubulin
inhibitors. No neurotoxicity has been observed at therapeutic doses
in rodents and in the ongoing Phase I trials. Indibulin has also
demonstrated synergy with approved anti-cancer agents in preclinical studies.
The availability of an oral capsule formulation of indibulin creates significant
commercial opportunity because no oral capsule formulations of microtubulin
inhibitors are currently on the market in the United States.
Indibulin,
as a single agent, has completed a Phase I trial in Europe and additional Phase
I trials are nearing completion in the U.S. in patients with advanced solid
tumors and the Company has reported clinical activity at well-tolerated doses
using a continuous dosing scheme without the development of clinically relevant
peripheral neuropathy. Following encouraging results obtained with
indibulin in combination with erlotinib, and 5-FU in preclinical models, two
Phase I combination studies were initiated with Tarceva® in one and Xeloda® in
another and are reaching completion. Favorable activity and safety
profile of oral indibulin with oral Xeloda® were reported at ASCO’s annual
meeting in May 2009. Preclinical work with consultant Dr. Larry
Norton to explore dose scheduling for the clinical setting have been completed
and were also reported at the ASCO meeting, supporting the Company’s plan to
initiate the Phase I portion of a Phase I/II breast cancer trial using a dose
schedule established preclinically.
Subject
to obtaining appropriate funding, we intend to continue with clinical
development of IV palifosfamide for soft tissue sarcoma and as the appropriate
circumstances would dictate, to initiate a clinical study with the oral form
following the United States Food and Drug Administration approval; with IV
darinaparsin, for PTCL and with the further development of the oral form; and
with oral indibulin, for solid tumors and in particular breast
cancer. However, the successful development of our product candidates
is highly uncertain. Product development costs and timelines can vary
significantly for each product candidate, are difficult to accurately predict,
and will require us to obtain additional funding, either alone or in connection
with partnering arrangements. Various statutes and regulations also
govern or influence the manufacturing, safety, labeling, storage, record keeping
and marketing of each product. The lengthy process of seeking
approval and the subsequent compliance with applicable statutes and regulations
require the expenditure of substantial resources. Any failure by us
to obtain, or any delay in obtaining, regulatory approvals could materially,
adversely affect our business. To date, we have not received approval
for the sale of any drug candidates in any market and, therefore, have not
generated any revenues from our drug candidates.
Corporate
Information
We were
originally incorporated in Colorado in September 1998 (under the name Net
Escapes, Inc.) and later changed our name to “EasyWeb, Inc.” in February 1999.
We were re-incorporated in Delaware on May 16, 2005 under the same name. On
September 13, 2005, we completed a “reverse” acquisition of privately held
ZIOPHARM, Inc., a Delaware corporation. To effect this transaction, we caused
ZIO Acquisition Corp., our wholly-owned subsidiary, to merge with and into
ZIOPHARM, Inc., with ZIOPHARM, Inc. surviving as our wholly owned subsidiary. In
accordance with the terms of the merger, the outstanding common stock of
ZIOPHARM, Inc. automatically converted into the right to receive an aggregate of
approximately 97.3% of our outstanding common stock (after giving effect to the
transaction). Following the merger, we caused ZIOPHARM, Inc. to merge with and
into us and we changed our name to “ZIOPHARM Oncology, Inc.” Although EasyWeb,
Inc. was the legal acquirer in the transaction, we accounted for the transaction
as a reverse acquisition under generally accepted accounting
principles. As a result, ZIOPHARM, Inc. became the registrant with
the Securities and Exchange Commission and the historical financial statements
of ZIOPHARM, Inc. became our historical financial statements.
Our
executive offices are located at 1180 Avenue of the Americas, 19th Floor, New
York, NY 10036, and our telephone number is (646) 214-0700. Our internet site is
www.ziopharm.com. None of the information on our internet site is part of this
prospectus supplement or the accompanying prospectus.
The
Offering
We are
offering shares of our common stock and warrants to purchase shares
of our common stock to purchasers pursuant to this prospectus supplement and the
accompanying prospectus. The common stock and warrants will be sold
in units, with each unit consisting of one share of common stock and a warrant
to purchase 0.50 of a share of common stock.
Common
stock offered
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15,484,000 shares
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|
|
Warrants
|
Warrants
to purchase up to 8,206,520 shares of our common stock will be
offered in this offering, including warrants to purchase up to an
aggregate of 7,742,000 shares of our common stock as part of the
units offered hereby and warrants to purchase up to an
additional 464,520 shares as underwriter compensation. The warrants
will have a term of five years and will be exercisable at any time after
the date of issuance at an exercise price of $4.02 per share. This
prospectus supplement also relates to the offering of the shares of common
stock issuable upon exercise of the warrants. For additional
information regarding the warrants, see “Description of Securities We are
Offering – Warrants ” below.
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|
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Common
stock outstanding after this offering
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41,192,287 shares
(assuming none of the warrants issued in the offering are
exercised)
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Use
of Proceeds
|
We
expect to use the net proceeds from this offering for general corporate
purposes, which may include the initiation of pivotal clinical trials for
some of our drug candidates, and general and administrative
expenses.
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|
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Risk
Factors
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See
“Risk Factors” and other information included or incorporated by reference
in this prospectus supplement and the accompanying prospectus for a
discussion of factors you should carefully consider before deciding to
invest in our securities.
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|
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Listing
|
Our common stock is
listed on the NASDAQ Capital Market under the symbol “ZIOP.” The last
reported price of our common stock on December 3, 2009 was $3.66 per
share. There is no established public trading market for the
offered warrants and we do not expect a market to develop. In addition, we
do not intend to apply for listing of the warrants on any national
securities
exchange.
|
The
amounts above are based on 25,708,287 common shares outstanding as of December
2, 2009 and assume no exercise of outstanding options or warrants since that
date. The number of common shares expected to be outstanding after this offering
excludes:
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·
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3,151,249
shares of our common stock issuable upon the exercise of outstanding stock
options as of December 2, 2009, including those issued under our 2003
Stock Option Plan, having a weighted average exercise price of $2.74 per
share;
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|
·
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1,246,068
shares of our common stock reserved for future issuance under our 2003
Stock Option Plan;
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·
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7,813,627
shares of our common stock issuable upon the exercise of outstanding
warrants as of December 2, 2009 with a weighted-average exercise price of
$4.22 per share; and
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|
·
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8,206,520 shares
of common stock issuable upon the exercise of the warrants to be issued in
this offering, including those to be issued as underwriting compensation,
at an exercise price of $4.02 per
share.
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RISK FACTORS
In considering whether to purchase
the securities, you should carefully consider all the information we have
included or incorporated by reference in this prospectus supplement and the
accompanying prospectus. In particular, you should carefully consider the
following risk factors, the factors listed in “Forward-Looking Statements” and
those commencing on page 7 of the accompanying prospectus, as well as those
incorporated by reference into this prospectus supplement and the accompanying
prospectus from the reports we file with the Securities and Exchange Commission
.. You should carefully review all the information in this prospectus supplement
and the accompanying prospectus about these securities.
Since
we have broad discretion in how we use the proceeds from this offering, we may
use the proceeds in ways with which you disagree.
We have
not allocated specific amounts of the net proceeds from this offering for any
specific purpose. Accordingly, our management will have significant flexibility
in applying the net proceeds of this offering. You will be relying on the
judgment of our management with regard to the use of these net proceeds, and you
will not have the opportunity, as part of your investment decision, to assess
whether the proceeds are being used appropriately. It is possible that the net
proceeds will be invested in a way that does not yield a favorable, or any,
return for us. The failure of our management to use such funds effectively could
have a material adverse effect on our business, financial condition, operating
results and cash flow.
There
is no minimum offering amount required to consummate this offering.
There is
no minimum offering amount which must be raised in order for us to consummate
this offering. Accordingly, the amount of money raised may not be sufficient for
us to meet our business objectives. Moreover, if only a small amount of money is
raised, all or substantially all of the offering proceeds may be applied to
cover the offering expenses and we will not otherwise benefit from the offering.
In addition, because there is no minimum offering amount required, investors
will not be entitled to a return of their investment if we are unable to raise
sufficient proceeds to meet our business objectives.
Investors
in this offering will pay a much higher price than the book value of our
stock.
If you
purchase units in this offering, you will incur an immediate and substantial
dilution in net tangible book value of $2.46 per share, based upon our tangible
net book value as of September 30, 2009 but after giving effect to the sale by
us of the common stock and warrants in this offering and assuming no exercise of
the warrants offered hereby.
There
is no public market for the warrants to purchase common stock in this
offering.
There is
no established public trading market for the warrants being offered in this
offering, and we do not expect a market to develop. In addition, we do not
intend to apply for listing the warrants on any securities exchange or other
trading market. Without an active market, the liquidity of the warrants will be
limited.
SPECIAL
NOTE REGARDING
FORWARD-LOOKING
STATEMENTS
This
prospectus supplement and the accompanying prospectus contain, and the documents
incorporated by reference herein and therein may contain, forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933, as
amended (the “Securities Act”), and Section 21E of the Securities Exchange Act
of 1934, as amended (the “Exchange Act”). These statements relate to
future events or to our future financial performance and involve known and
unknown risks, uncertainties and other factors which may cause our actual
results, performance or achievements to be materially different from any future
results, performances or achievements expressed or implied by the
forward-looking statements. Forward-looking statements may include, but are not
limited to statements about:
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·
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the
progress of preclinical and clinical trials involving our drug
candidates;
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·
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the
progress of our research and development
programs;
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·
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the
risk that final trial data may not support interim analysis of the
viability of our drug candidates;
|
|
·
|
the
benefits to be derived from relationships with our
collaborators;
|
|
·
|
the
receipt or anticipated receipt of regulatory clearances and
approvals;
|
|
·
|
our
ability to adequately protect our intellectual property
rights;
|
|
·
|
our
estimates of future revenues and profitability;
and
|
|
·
|
our
estimates regarding our capital requirements and our need for additional
financing.
|
In some
cases, you can identify forward-looking statements by terms such as “may,”
“will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,”
“believes,” “estimates,” “projects,” “predicts,” “potential” and similar
expressions intended to identify forward-looking statements. These statements
reflect our current views with respect to future events and are based on
assumptions and subject to risks and uncertainties. Given these uncertainties,
you should not place undue reliance on these forward-looking statements. We
discuss many of these risks in greater detail under the heading “Risk Factors”
in this prospectus supplement and the accompanying prospectus and in our reports
filed from time to time under the Securities Act and/or the Exchange
Act. We encourage you to read these filings as they are
made.
Further,
any forward-looking statement speaks only as of the date on which it is made,
and we undertake no obligation to update any forward-looking statement or
statements to reflect events or circumstances after the date on which such
statement is made or to reflect the occurrence of unanticipated events. New
factors emerge from time to time, and it is not possible for us to predict which
factors will arise. In addition, we cannot assess the impact of each factor on
our business or the extent to which any factor, or combination of factors, may
cause actual results to differ materially from those contained in any
forward-looking statements.
USE OF PROCEEDS
We expect
the net proceeds from this offering to be approximately $45.2 million,
after deducting the underwriting discounts and commissions, as described in
“Underwriting,” and other estimated offering expenses payable by us, which
include legal, accounting and printing fees.
We intend
to use the net proceeds from the sale of the securities under this prospectus
supplement for general corporate purposes, including the initiation of pivotal
clinical trials for our drug candidates, darinaparsin and palifosfamide, working
capital, and general operating and administrative expenses. However,
as of the date of this prospectus supplement, we cannot specify with certainty
all of the particular uses of the proceeds from this offering. Accordingly, we
will retain broad discretion over the use of such proceeds. Pending the use of
the net proceeds from this offering as described above, we intend to invest the
net proceeds in investment-grade, interest-bearing instruments.
DILUTION
The net
tangible book value of our common stock on September 30, 2009 was approximately
$3.9 million, or approximately $0.15 per share, based on 25,571,301 shares of
our common stock outstanding as of September 30, 2009. Net tangible
book value per share represents the amount of our total tangible assets, less
our total liabilities, divided by the total number of shares of our common stock
outstanding. Dilution in net tangible book value per share to new investors
represents the difference between the amount per unit paid by purchasers of
securities in this offering and the net tangible book value per share of our
common stock immediately afterwards. Without taking into account any other
changes in net tangible book value after September 30, 2009, other than the sale
of 15,484,000 units offered by us hereby at a price of $3.10 per unit
and after deducting underwriting discounts and commissions and our estimated
offering expenses, our net tangible book value at September 30, 2009 would have
been approximately $26.3 million, or approximately $0.64 per share.
This represents an immediate increase in net tangible book value of
approximately $0.49 per share to existing shareholders and an immediate
dilution in net tangible book value of $2.46 per share to investors in this
offering. Our net tangible book value calculation assumes no exercise of the
warrants offered hereby.
The
following table illustrates this per share dilution:
Public
offering price per unit
|
|
|
|
|
|
$3.10 |
|
Net tangible book value per share as of September
30, 2009
|
|
|
$0.15 |
|
|
|
|
|
Increase in net tangible book value per share
attributable to this offering
|
|
|
$0.49 |
|
|
|
|
|
Net
tangible book value per share as of September 30, 2009, after giving
effect to this offering
|
|
|
|
|
|
|
$0.64 |
|
Dilution
per share to new investors in the offering
|
|
|
|
|
|
|
$2.46 |
|
Investors
that purchase common stock upon exercise of the warrants offered hereby may
experience dilution depending on our net tangible book value at the time of
exercise.
The
amounts above are based on 25,571,301 common shares outstanding as of September
30, 2009 and assume no exercise of outstanding options or warrants since that
date. The number of common shares expected to be outstanding after this offering
excludes:
|
·
|
3,151,249
shares of our common stock issuable upon the exercise of outstanding stock
options, including those issued under our 2003 Stock Option Plan, having a
weighted average exercise price of $2.74 per
share;
|
|
·
|
1,246,068
shares of our common stock reserved for future issuance under our 2003
Stock Option Plan;
|
|
·
|
7,950,613
shares of our common stock issuable upon the exercise of warrants
outstanding at September 30, 2009 with a weighted-average exercise price
of $4.18 per share; and
|
|
·
|
8,206,520 shares
of common stock issuable upon the exercise of warrants to be issued in
this offering, including those to be issued as underwriting compensation,
at an exercise price of $4.02 per
share.
|
To the
extent options or warrants outstanding as of September 30, 2009 have been or may
be exercised or other shares have been issued, there may be further dilution to
investors.
DESCRIPTION
OF SECURITIES WE ARE OFFERING
In this
offering, we are offering 15,484,000 units, consisting of 15,484,000
shares of common stock and warrants to purchase 7,742,000 shares of common
stock. Each unit consists of one share of common stock and warrants to purchase
0.50 of a share of common stock at an exercise price of $4.02 per
share. We are also issuing warrants to purchase up to an aggregate
of 464,520 shares of our common stock at an exercise price of $4.02 per
share to the underwriters as underwriting compensation. This
prospectus supplement also relates to the offering of shares of our common stock
upon exercise, if any, of the warrants.
Common
Stock
The
material terms and provisions of our common stock are described under the
caption “Description of Capital Stock” starting on page 7 of the accompanying
prospectus.
Warrants
The
material terms and provisions of the warrants being offered pursuant to this
prospectus supplement are summarized below. This summary is subject to, and
qualified in its entirety by, the form of warrant included as an exhibit to our
Current Report on Form 8-K that will be filed with the SEC in connection with
this offering.
Exercisability. The
warrants will have a term of five years. The warrants issued as part of the
units offered hereby will be exercisable at any time following the date of
issuance and the warrants issued as underwriting compensation will be
exercisable at any time after six months following the date of issuance. The
warrants will be exercisable, at the option of each holder, upon the surrender
of the warrants to us and the payment in cash, or in the case of a cashless
exercise described below, by delivery of shares of common stock by the holder
equal in value to the exercise price of the shares being acquired upon exercise
of the warrants. The holder will not have the right to exercise any portion of
the warrant if the holder, together with its affiliates, would beneficially own
in excess of 9.99% (the “Maximum Percentage”) of the number of shares of our
common stock outstanding immediately after the exercise, provided however, that
upon 61 days’ prior written notice, the holder may increase the Maximum
Percentage to 19.99%. If shares are not delivered to the holder of any warrant
within three trading days of such holder’s due exercise thereof, and prior to
the time such shares are received, the holder purchases shares of our
common stock to deliver in satisfaction of a sale by the holder of shares to be
issued upon such exercise (a “Buy-in”), then we will be required to pay the
holder the amount by which the total purchase price paid for common stock as a
result of the Buy-in (including brokerage commissions, if any) exceeds the
proceeds received by such holder as a result of the sale to which such Buy-in
relates.
Cashless Exercise. If there
is no effective registration statement registering the issuance of shares of
common stock issuable upon exercise of the warrants issued to purchasers in this
offering, then such warrants may be exercised by means of a “cashless exercise”
in which the holder will be entitled to surrender a portion of the shares of
common stock subject to the warrant in lieu of cash for the exercise price. The
warrants to be issued in this offering as underwriting compensation may be
exercised by means of a “cashless exercise” at any time during which such
warrants are exercisable.
Exercise Price. The exercise
price per share of common stock purchasable upon exercise of the warrants issued
in this offering, including those being issued as underwriting compensation, is
$4.02. The exercise price is subject to appropriate adjustment in the event of
stock dividends, stock splits, stock combinations, reclassifications or similar
events affecting our common stock.
If, any
time prior to the four year anniversary of the warrants’ initial issue date, we
sell or issue shares of our common stock, rights, options or warrants
to purchase shares of our common stock, other rights for shares of our common
stock, or securities convertible or exchangeable into shares of our common
stock, in any case at a price per share less than the than applicable warrant
exercise price, then in each such case the warrant exercise price will be
reduced to the price determined by multiplying the exercise price in effect
immediately prior to such issuance by a fraction, (A) the numerator of which
will be the number of shares of our common stock outstanding immediately prior
to such issuance plus the number of shares which the aggregate consideration
received for such issuance would purchase at the exercise price in effect
immediately prior to such issuance, and (B) the denominator of which will be the
number of shares of our common stock outstanding immediately after such
issuance; provided, however, that no such sale or issuance will reduce the
warrant exercise price to an amount less than $0.50 (which $0.50 floor is
subject to appropriate adjustment in the event of stock dividends, stock splits,
stock combinations, reclassifications or similar events affecting our common
stock). In determining whether a sale or issuance is at a price per share
less than the than applicable warrant exercise price, we will take into account
any consideration received by us for such sale or issuance, any consideration
required to be paid upon the exercise, conversion, or exchange, as applicable,
of the issued securities and the fair market value of all other consideration
(if other than cash). Any adjustment to the warrant exercise price
made upon the issuance of convertible securities, and any subsequent adjustments
based thereon, will be recomputed upon any expiration or termination of
conversion rights in order to reflect the issuance of only the number of shares
actually issued upon the conversion and the actual consideration received.
Notwithstanding the foregoing, the following issuances will not trigger
adjustments in the warrant exercise price: (i) the issuance of securities upon
the exercise or conversion of any convertible securities issued by us prior to
the date hereof (unless the conversion price, exercise price or number of shares
issuable thereunder is amended, modified or changed), (ii) the grant of options,
warrants, common stock or other convertible securities (but not including any
amendments to such instruments) under any stock option, restricted stock plan or
stock purchase plan approved by us and our stockholders, and the issuance of
common stock in respect thereof, or (iii) the issuance of securities in a
transaction that otherwise results in an adjustment to the warrant exercise
price.
Transferability. The warrants
issued in the offering may be transferred at the option of the warrant holder
upon surrender of the warrants to the Company with the appropriate instruments
of transfer.
Effect of Fundamental
Transaction. If (i) we merge or consolidate with or into another
entity, in which our stockholders as of immediately prior to the transaction own
less than a majority of the outstanding stock of the surviving entity, (ii) we
sell of all or substantially all of our assets in one or a series of related
transactions, (iii) a tender or exchange offer is completed pursuant to which
all or substantially all of our stockholders are permitted to tender or exchange
their shares for other securities, cash or property and would result in our
stockholders immediately prior to such offer owning less than a majority of the
outstanding stock thereafter, (iv) if we reclassify our common stock or
effect any compulsory share exchange pursuant to which our common stock is
effectively converted into or exchanged for other securities, cash or property,
(v)
we consummate a stock purchase transaction or other business combination with a
third party whereby that third party acquires more than the 50% of our
outstanding common stock, or (vi) we consummate a transaction in which any
“person” or “group” (as these terms are used for purposes of Sections 13(d) and
14(d) of the Securities Exchange Act of 1934, as amended) is or becomes the
“beneficial owner” (as defined in Rule 13d-3 under the Securities Exchange Act
of 1934, as amended) of a majority of the voting power represented by our
outstanding common stock (each a “Fundamental Transaction”), then the
holder of any warrants will thereafter receive upon exercise of the
warrants the same amount and kind of securities, cash or property to which
a holder of the number of shares of common stock then issuable upon the exercise
or conversion of such warrants would have been entitled upon such
transaction. Notwithstanding
the foregoing, in the event of a Fundamental Transaction, we or the surviving
company (as applicable) will be required, at the warrant holder’s option,
exercisable at any time within 90 days after the Fundamental Transaction, to
purchase the warrant from such holder by paying to such holder an amount of cash
equal to the Black Scholes Value of the remaining unexercised portion of such
holder’s warrant as of the date that the Fundamental Transaction is consummated.
As used herein, “Black Scholes Value” means the value of such holder’s warrant
based on the Black and Scholes Option Pricing Model obtained from the “OV”
function on Bloomberg determined as of the day of the closing of the applicable
Fundamental Transaction for pricing purposes and reflecting (i) a risk-free
interest rate corresponding to the U.S. Treasury rate for a period equal to the
remaining term of the warrant as of such date of request, (ii) an expected
volatility equal to the greater of 100% and the 100 day volatility obtained from
the HVT function on Bloomberg as of the day immediately following the public
announcement of the applicable Fundamental Transaction, (iii) the underlying
price per share used in such calculation shall be the sum of the price per share
being offered in cash, if any, plus the value of any non cash consideration, if
any, being offered in the Fundamental Transaction, and (iv) a 365 day
annualization factor.
Rights Upon Distribution of
Assets. If at any time while the warrant is outstanding, we declare or
make any dividend or other distribution of our assets (or rights to acquire our
assets) to holders of our common stock, by way of return of capital or
otherwise, then in each such case we shall will distribute such assets pro rata
to the warrant holder on the record date or date of effectiveness, as the case
may be, fixed for determining the holders of common stock entitled to
participate therein, in an amount equal to the amount that such holder would
have been entitled to receive had such holder’s warrants been exercised in full
(without regard to any limitations on the exercise of the warrants) immediately
prior to the time for determination of the holders of common stock entitled to
participate in such distribution.
UNDERWRITING
We are
offering the securities described in this prospectus supplement through
underwriters. JMP Securities LLC and Rodman & Renshaw, LLC
are acting as co-lead
managers of
the offering. We have
entered into a firm commitment underwriting agreement with the underwriters.
Subject to the terms and conditions of the underwriting agreement, we have
agreed to sell to the underwriters, and each underwriter has severally agreed to
purchase, at the public offering price less the underwriting discount set forth
on the cover page of this prospectus supplement, the number of units listed next
to its name in the following table:
Underwriter
|
|
Number
of Units
|
|
JMP
Securities LLC
|
|
|
8,602,222 |
|
Rodman
& Renshaw, LLC
|
|
|
6,881,778 |
|
Total
|
|
|
15,484,000 |
|
The
underwriting agreement provides that the obligations of the underwriters to pay
for and accept delivery of the units offered by this prospectus supplement are
subject to the approval of certain legal matters by their counsel and certain
other conditions. The underwriters are committed to purchase
all the units offered by us if they purchase any units. The underwriting
agreement also provides that if an underwriter defaults, the purchase
commitments of non-defaulting underwriter(s) may also be increased or the
offering may be terminated.
Commission
and Expenses
The
underwriters have advised us that they propose to offer the units to the public
at the public offering price set forth on the cover page of this prospectus
supplement and to certain dealers at that price less a concession not in excess
of $0.1004 per share.
The
following table shows the per unit and total underwriting discount to be paid to
the underwriters.
Underwriting
discount per unit
|
|
$ |
0.1674 |
|
Total underwriting
discount
|
|
$ |
2,592,021.60 |
|
We
estimate that the total fees and expenses payable by us, excluding underwriting
discounts, will be approximately $200,000, which includes up to $125,000 that we
have agreed to reimburse the underwriters for the fees incurred by them in
connection with the offering.
In
compliance with the guidelines of FINRA, the maximum consideration or discount
to be received by any FINRA member or independent broker dealer may not exceed
8% of the aggregate amount of the securities offered pursuant to this prospectus
supplement.
Lock-up
Agreements
We and
each of our directors and executive officers are subject to lock-up agreements
that prohibit us and them, subject to certain exceptions, from offering for
sale, selling, contracting to sell, pledging, granting any option, right or
warrant to purchase, or otherwise transferring or disposing of, any shares of
our common stock or any securities convertible into or exercisable or
exchangeable for shares of our common stock for a period of 90 days from the
date of this prospectus supplement without the prior written consent of JMP Securities LLC
as the representative of the underwriters. The lock-up agreement does not
prohibit our executive officers from transferring shares of our common stock to
us to cover taxes payable upon the lapse of restrictions on previously awarded
restricted stock grants and permits our directors to sell limited amounts of
shares for the same purpose. The lock-up agreement does not prohibit us from
issuing shares upon the exercise or conversion of securities outstanding on the
date of this prospectus supplement. The lock-up provisions do not prevent us
from selling shares to the underwriters pursuant to the underwriting agreement,
or from granting options to acquire securities under our existing stock option
plans or issuing shares upon the exercise or conversion of securities
outstanding on the date of this prospectus supplement.
The
lock-up period in all of the lock-up agreements is subject to extension if
(i) during the last 17 days of the lock-up period we issue an earnings
release or material news or a material event relating to us occurs or
(ii) prior to the expiration of the lock-up period, we announce that we
will release earnings results during the 16-day period beginning on the last day
of the lock-up period, in which case the restrictions imposed in these lock-up
agreements shall continue to apply until the expiration of the 18-day period
beginning on the issuance of the earnings release or the occurrence of the
material news or material event, unless JMP Securities LLC waives the extension
in writing.
Price
Stabilization; Short Positions and Penalty Bids
Until the
distribution of the units of common stock and warrants is completed, SEC rules
may limit the underwriters from bidding for and purchasing shares of our common
stock.
In
connection with this offering, the underwriters may engage in transactions that
stabilize, maintain or otherwise make short sales of our common stock and may
purchase our common stock on the open market to cover positions created by short
sales. Short sales involve the sale by the underwriters of a greater number of
shares than they are
required to purchase in this offering. The underwriters may close out any short
position by purchasing shares in the open market.
A short
position is more likely to be created if the underwriters are concerned that
there may be downward pressure on the price of the shares in the open market
after pricing that could adversely affect investors who purchase in this
offering. A “stabilizing bid” is a bid for or the purchase of common stock on
behalf of the underwriters in the open market prior to the completion of this
offering for the purpose of fixing or maintaining the price of the shares of
common stock. A “syndicate covering transaction” is the bid for or purchase of
common stock on behalf of the underwriters to reduce a short position incurred
by the underwriters in connection with the offering.
Similar
to other purchase transactions, the underwriters’ purchases to cover the
syndicate short sales may have the effect of raising or maintaining the market
price of our shares or preventing or retarding a decline in the market price of
our shares. As a result, the price of our shares may be higher than the price
that might otherwise exist in the open market.
In
connection with this offering, the underwriters may also engage in passive
market making transactions in our common stock on the Nasdaq Capital Market in
accordance with Rule 103 of Regulation M during a period before the
commencement of offers or sales of shares of our common stock in this offering
and extending through the completion of distribution. A passive market maker
must display its bid at a price not in excess of the highest independent bid of
that security. However, if all independent bids are lowered below the passive
market maker's bid, that bid must then be lowered when specified purchase limits
are exceeded.
Neither
we, nor the underwriters make any representation or prediction as to the
direction or magnitude of any effect that the transactions described above may
have on the price of our common stock. In addition, neither we nor the
underwriters make any representation that the representative will engage in
these transactions or that any transaction, if commenced, will not be
discontinued without notice.
Indemnification
We have
agreed to indemnify the underwriters against certain liabilities, including
liabilities under the Securities Act, and liabilities arising from breaches of
representations and warranties contained in the underwriting agreement. We have
also agreed to contribute to payments the underwriters may be required to make
in respect of such liabilities.
WHERE
YOU CAN FIND MORE INFORMATION
We are a
reporting company and file annual, quarterly and current reports, proxy
statements and other information with the SEC. You may read and copy these
reports, proxy statements and other information at the SEC’s public reference
room at 100 F. Street, N.E., Washington, D.C. 20549 or at the SEC’s other public
reference facilities. Please call the SEC at 1-800-SEC-0330 for more information
about the operation of the public reference rooms. You can request copies of
these documents by writing to the SEC and paying a fee for the copying
costs. In addition, the SEC maintains an Internet site at http://www.sec.gov
that contains reports, proxy and information statements and other information
regarding issuers that file electronically with the SEC. Our SEC
filings are available on the SEC’s Internet site.
INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
We are
allowed to incorporate by reference information contained in documents that we
file with the SEC. This means that we can disclose important information to you
by referring you to those documents and that the information in this prospectus
supplement is not complete and you should read the information incorporated by
reference for more detail. We incorporate by reference in two ways. First, we
list certain documents that we have already filed with the SEC. The information
in these documents is considered part of this prospectus supplement. Second, the
information in documents that we file in the future will update and supersede
the current information in, and incorporated by reference in, this prospectus
supplement.
We
incorporate by reference the documents listed below and any future filings we
will make with the SEC under Section 13(a), 13(c), 14 or 15(d) of the
Securities Exchange Act of 1934, as amended, or the Exchange Act (other than
information furnished in Current Reports on Form 8-K filed under Item 2.02
or 7.01 of such form):
|
·
|
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, 2009, June
30, 2009, and September 30, 2009, filed on May 15, 2009, August 14, 2009,
and November 11, 2009,
respectively;
|
|
·
|
Current
Reports on Form 8-K filed on June 1, 2009, June 4, 2009, September 15,
2009, October 14, 2009, and November 6, 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.
|
We will
provide to each person, including any beneficial owner, to whom a prospectus
supplement is delivered, a copy of any or all of the information that has been
incorporated by reference in this prospectus supplement but not delivered with
this prospectus supplement. You may request a copy of this information at no
cost, by writing or telephoning us at the following address or telephone
number:
ZIOPHARM
Oncology, Inc.
1180
Avenue of the Americas, 19th Floor
New York,
NY 10036
Attention:
President
Telephone:
(646) 214-0700
You
should rely only on the information incorporated by reference or provided in
this prospectus supplement or the accompanying prospectus. We have not
authorized anyone else to provide you with different information. You should not
assume that the information in this prospectus supplement is accurate as of any
date other than the date on the front of this prospectus
supplement.
LEGAL
MATTERS
The
validity of the issuance of the securities offered hereby will be passed upon by
our counsel, Maslon Edelman Borman & Brand, LLP, Minneapolis,
Minnesota. The underwriters are being represented in connection with
this offering by Goodwin Procter LLP, New York, New York.
EXPERTS
The
financial statements incorporated in this prospectus supplement by reference
from the Company’s Annual Report on Form 10-K for the year ended
December 31, 2008 have been audited by Vitale, Caturano & Company,
P.C., (whose name has been changed to Caturano and Company, P.C. effective May
1, 2009), as stated in their report incorporated in this prospectus supplement
by reference, and have been so incorporated in reliance upon the report of such
firm given upon their authority as experts in accounting and
auditing.
PROSPECTUS
$75,000,000
ZIOPHARM
Oncology, Inc.
Common
Stock, Preferred Stock,
Warrants
and Debt Securities
We may
offer and sell any combination of common stock, preferred stock, warrants and
debt securities, with a total initial offering price of up to
$75,000,000.
This
prospectus provides a general description of securities we may offer and sell
from time to time. Each time we sell these securities, we will provide their
specific terms in a supplement to this prospectus. This prospectus supplement
may also add, update or change information contained in this prospectus. You
should read this prospectus and the applicable prospectus supplement carefully
before you invest in any securities. This prospectus may not be used to
consummate a sale of securities unless accompanied by the applicable prospectus
supplement.
We
may offer and sell these securities, from time to time, to or through one or
more underwriters, dealers and agents, or directly to purchasers, on a
continuous or delayed basis, at prices and on other terms to be determined at
the time of offering. If we use agents, underwriters or dealers to sell the
securities, we will name them and describe their compensation in a prospectus
supplement.
Our
common stock is listed on the Nasdaq Capital Market under the symbol
“ZIOP.” On September 10, 2009, the closing price of our common stock,
as reported on the Nasdaq Capital Market, was $1.71. We urge
prospective purchasers of our common stock to obtain current information about
the market prices of our common stock.
Neither
the Securities and Exchange Commission nor any state securities commission has
approved or disapproved these securities or determined if this prospectus is
truthful or complete. A representation to the contrary is a criminal
offense.
The date
of this Prospectus is September 21, 2009.
TABLE
OF CONTENTS
|
Page
|
About
This Prospectus
|
i
|
Prospectus
Summary
|
1
|
Risk
Factors
|
4
|
Special
Note Regarding Forward-Looking Statements
|
4
|
Ratio
of Earnings to Fixed Charges
|
5
|
Use
of Proceeds
|
5
|
Plan
of Distribution
|
5
|
Description
of Capital Stock
|
7
|
Description
of Debt Securities
|
9
|
Description
of Warrants
|
16
|
Certain
Provisions of Delaware Law, the Certificate of Incorporation and
Bylaws
|
18
|
Where
You Can Find More Information
|
19
|
Incorporation
of Certain Information by Reference
|
20
|
Legal
Matters
|
20
|
Experts
|
20
|
ABOUT
THIS PROSPECTUS
This
prospectus is part of a registration statement that we filed with the Securities
and Exchange Commission, or SEC, using a “shelf” registration process. Under
this shelf registration process, from time to time, we may sell any combination
of the securities described in this prospectus in one or more offerings, up to a
total dollar amount of $75,000,000. This prospectus provides you with a general
description of the securities we may offer. Each time we offer and sell
securities under this prospectus, we will provide a prospectus supplement that
will contain more specific information about the terms of the applicable
offering. We may also add, update or change in the prospectus supplement any of
the information contained in this prospectus. This prospectus, together with the
applicable prospectus supplement(s) and the documents incorporated by reference
into this prospectus and such supplement(s), includes all material information
relating to this offering. To the extent there is a conflict between the
information contained in this prospectus and the prospectus supplement, you
should rely on the information in the prospectus supplement; provided that, if
any statement in one of these documents is inconsistent with a statement in
another document having a later date — for example, a document incorporated by
reference in this prospectus or any prospectus supplement — the statement in the
document having the later date modifies or supersedes the earlier statement.
Please carefully read both this prospectus and any prospectus supplement,
together with the additional information described below under “Where You Can
Find More Information,” before buying securities in this offering.
You
should rely only on the information contained or incorporated by reference in
this prospectus or a prospectus supplement. We have not authorized any other
person to provide you with different information. If anyone provides you with
different or inconsistent information, you should not rely on it. This
prospectus and the accompanying supplement to this prospectus do not constitute
an offer to sell or the solicitation of an offer to buy any securities other
than the registered securities to which they relate, nor do this prospectus and
the accompanying supplement to this prospectus constitute an offer to sell or
the solicitation of an offer to buy securities in any jurisdiction to any person
to whom it is unlawful to make such offer or solicitation in such jurisdiction.
You should not assume that the information contained in this prospectus and the
accompanying prospectus supplement is accurate on any date subsequent to the
date set forth on the front cover of this document or that any information we
have incorporated by reference is correct on any date subsequent to the date of
the document incorporated by reference, even though this prospectus and any
accompanying prospectus supplement is delivered or securities sold on a later
date.
This
prospectus may not be used to consummate a sale of our securities unless it is
accompanied by a prospectus supplement.
PROSPECTUS
SUMMARY
The
following is a summary of this prospectus. Because it is only a summary, it does
not contain all of the detailed information contained elsewhere in this
prospectus or in the documents incorporated by reference into this prospectus or
included as exhibits to the registration statement that contains this
prospectus. Accordingly, you are urged to carefully review this prospectus
(including all documents incorporated by reference into this prospectus) in its
entirety. Unless otherwise indicated, “ZIOPHARM,” our “Company,”
“we,” “us,” “our” and similar terms refer to ZIOPHARM Oncology,
Inc.
Our
Company
ZIOPHARM
Oncology, Inc. is a biopharmaceutical company that is seeking to develop and
commercialize a diverse, risk-sensitive portfolio of in-licensed cancer drugs
that can address unmet medical needs through enhanced efficacy and/or safety and
quality of life. Our principal focus is on the licensing and development of
proprietary small molecule drug candidates that are related to cancer
therapeutics already on the market or in development and can be administered by
intravenous (“IV”) and/or oral capsule forms. We believe this
strategy will result in lower risk and expedited drug development programs with
product candidates having a low cost of manufacturing to address changing
reimbursement requirements around the world. While we may
commercialize our products on our own in North America, we recognize that
favorable clinical trial results can be better addressed by partnering with
companies with the requisite financial resources. The Company could
also negotiate the right to complete development and marketing in certain
geographies especially for certain limited (niche) indications. Although we are
currently in Phase I and/or II studies for three product candidates identified
as darinaparsin (ZinaparTM, ZIO-101), palifosfamide (ZymafosTM, ZIO-201), and
indibulin (ZybulinTM, ZIO-301), the Company’s current focus is on palifosfamide
and more specifically on completing initial enrollment of the ongoing randomized
Phase II trial with palifosfamide to support a registration trial for
palifosfamide in combination with doxorubicin in the front- and second-line
setting of soft tissue sarcoma. We anticipate the initiation of such
a trial as early as the first half of 2010.
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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 and the European Union for the treatment of acute
promyelocytic leukemia (“APL”), a precancerous condition. 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 detected activity against a series of tumor cell lines
including 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. 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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Phase I
testing of the intravenous form of darinaparsin in solid tumors and
hematological cancers has been completed. The Company reported
clinical activity and, importantly, a safety profile from these studies as
predicted by preclinical results. The Company subsequently completed
Phase II studies in advanced myeloma and primary liver cancer and is nearing
completion of a Phase II study in certain other hematological
cancers. In addition, the Company is completing two Phase I studies
with an oral capsule form of darinaparsin. At the May 2009 annual
meeting of the American Society of Clinical Oncology (“ASCO”), the Company
reported favorable results from the trial with IV-administered darinaparsin in
lymphoma, particularly peripheral T-cell lymphoma (“PTCL”). In the
ongoing Phase I trials, also reported at the ASCO annual meeting, preliminary
data primarily in solid tumors indicate the oral form is active and well
tolerated. The Company is actively seeking a partner or other sources
of funding to progress the IV program into a potentially pivotal trial in PTCL
as early as the first half of 2010 as well as to complete the oral Phase I
program. If we cannot find a partner or otherwise raise the capital
for continuing the darinaparsin programs, our intent is to complete the ongoing
studies included in the Company’s current estimate of expenses and then place
the development program for darinaparsin on hold.
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ZIO-201,
or palifosfamide (ZymafosTM), is the active metabolite of ifosfamide, a
compound chemically related to cyclophosphamide. 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 and ifosfamide,
palifosfamide is an alkylating agent. 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. More importantly, 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 ("FDA") 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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Following
Phase I study, Phase II testing of the intravenous form of palifosfamide as a
single agent to treat advanced sarcoma has been completed. In both
Phase I and Phase II testing, palifosfamide has been administered without the
“uroprotectant” mesna, and the toxicities associated with acrolein and
chloroacetaldehyde have not been observed. The Company reported
clinical activity of palifosfamide when used alone in the Phase II study
addressing advanced sarcoma. Following review of the preclinical
combination studies, clinical data, and discussion with sarcoma experts, the
Company initiated a Phase I dose escalation study of palifosfamide in
combination with doxorubicin in patients with metastatic or unresectable soft
tissue sarcoma. The Company reported favorable results and safety
profile from this study at the ASCO annual meeting. In light of
reported favorable Phase II clinical activity data and with the combination of
palifosfamide with doxorubicin well tolerated in the Phase I trial and
evidencing activity, the Company initiated a Phase II randomized controlled
trial in the second half of last year to compare doxorubicin plus palifosfamide
to doxorubicin alone in patients with front and second-line metastatic or
unresectable soft tissue sarcoma. Data from the initial patients in
this trial are expected to shape a registration trial in the same setting which
is expected to initiate as early as the first half of 2010. The study
is currently actively enrolling and, in conjunction with ASCO, the initial drug
safety monitoring committee meeting concluded to continue enrollment as
planned. The Company is also developing an oral capsule form of
palifosfamide to be studied clinically following further data from the IV trials
and partnering or other sources of funding. The Company is also
considering additional Phase II trials in other solid tumors as funding becomes
available. Orphan Drug Designation for palifosfamide has been
obtained in both the United States and the European Union for the treatment of
soft tissue sarcomas.
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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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Preclinical
studies with indibulin demonstrate significant and broad antitumor activity,
including activity against taxane-refractory cell lines. The
cytotoxic activity of indibulin was demonstrated in several rodent and human
tumor cell lines derived from prostate, brain, breast, pancreas, lung, ovary,
and cervical tumor tissues and in rodent tumor and human tumor xenograft
models. In addition, indibulin was effective against multidrug
resistant tumor cell lines (breast, lung, and leukemia) both in vitro and in
vivo. Indibulin is potentially safer than other tubulin
inhibitors. No neurotoxicity has been observed at therapeutic doses
in rodents and in the ongoing Phase I trials. Indibulin has also
demonstrated synergy with approved anti-cancer agents in preclinical studies.
The availability of an oral capsule formulation of indibulin creates significant
commercial opportunity because no oral capsule formulations of microtubulin
inhibitors are currently on the market in the United States.
Indibulin,
as a single agent, has completed a Phase I trial in Europe and additional Phase
I trials are nearing completion in the U.S. in patients with advanced solid
tumors and the Company has reported clinical activity at well-tolerated doses
using a continuous dosing scheme without the development of clinically relevant
peripheral neuropathy. Following encouraging results obtained with
indibulin in combination with erlotinib, and 5-FU in preclinical models, two
Phase I combination studies were initiated with Tarceva® in one and Xeloda® in
another and are reaching completion. Favorable activity and safety
profile of oral indibulin with oral Xeloda® were reported at ASCO’s annual
meeting in May 2009. Preclinical work with consultant Dr. Larry
Norton to explore dose scheduling for the clinical setting have been completed
and were also reported at the ASCO meeting, supporting the Company’s plan,
subject to the availability of additional funding, to initiate a Phase I/II
breast cancer trial using a dose schedule established
preclinically.
Subject
to obtaining appropriate funding, we intend to continue with clinical
development of IV palifosfamide for soft tissue sarcoma and to initiate a
clinical study with the oral form following the United States Food and Drug
Administration approval; with IV darinaparsin, for PTCL and with the further
development of the oral form; and with oral indibulin, for solid tumors and in
particular breast cancer. However, the successful development of our
product candidates is highly uncertain. Product development costs and
timelines can vary significantly for each product candidate, are difficult to
accurately predict, and will require us to obtain additional funding, either
alone or in connection with partnering arrangements. Various statutes
and regulations also govern or influence the manufacturing, safety, labeling,
storage, record keeping and marketing of each product. The lengthy
process of seeking approval and the subsequent compliance with applicable
statutes and regulations require the expenditure of substantial
resources. Any failure by us to obtain, or any delay in obtaining,
regulatory approvals could materially, adversely affect our
business. To date, we have not received approval for the sale of any
drug candidates in any market and, therefore, have not generated any revenues
from our drug candidates.
Corporate
Information
We were
originally incorporated in Colorado in September 1998 (under the name Net
Escapes, Inc.) and later changed our name to “EasyWeb, Inc.” in February 1999.
We were re-incorporated in Delaware on May 16, 2005 under the same name. On
September 13, 2005, we completed a “reverse” acquisition of privately held
ZIOPHARM, Inc., a Delaware corporation. To effect this transaction, we caused
ZIO Acquisition Corp., our wholly-owned subsidiary, to merge with and into
ZIOPHARM, Inc., with ZIOPHARM, Inc. surviving as our wholly owned subsidiary. In
accordance with the terms of the merger, the outstanding common stock of
ZIOPHARM, Inc. automatically converted into the right to receive an aggregate of
approximately 97.3% of our outstanding common stock (after giving effect to the
transaction). Following the merger, we caused ZIOPHARM, Inc. to merge with and
into us and we changed our name to “ZIOPHARM Oncology, Inc.” Although EasyWeb,
Inc. was the legal acquirer in the transaction, we accounted for the transaction
as a reverse acquisition under generally accepted accounting
principles. As a result, ZIOPHARM, Inc. became the registrant with
the Securities and Exchange Commission and the historical financial statements
of ZIOPHARM, Inc. became our historical financial statements.
Our
executive offices are located at 1180 Avenue of the Americas, 19th Floor, New
York, NY 10036, and our telephone number is (646) 214-0700. Our internet site is
www.ziopharm.com. None of the information on our internet site is part of this
prospectus.
RISK
FACTORS
As with
most pharmaceutical product candidates, the development of our product
candidates is subject to numerous risks, including the risk of delays in or
discontinuation of development from lack of financing, inability to obtain
necessary regulatory approvals to market the products, unforeseen safety issues
relating to the products and dependence on third party collaborators to conduct
research and development of the products. Because we are a
development stage company with a limited history of operations, we are also
subject to many risks associated with early-stage companies. For a
more detailed discussion of the risks you should consider before purchasing
shares of our common stock, you should carefully consider the specific risks
discussed under “Risk Factors” in the applicable prospectus supplement and in
our filings with the Securities and Exchange Commission that are incorporated by
reference in this prospectus and such prospectus supplement.
SPECIAL
NOTE REGARDING
FORWARD-LOOKING
STATEMENTS
This
prospectus contains, and the documents incorporated by reference herein and in
any prospectus supplement hereto may contain, forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as amended (the
“Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as
amended (the “Exchange Act”). These statements relate to future
events or to our future financial performance and involve known and unknown
risks, uncertainties and other factors which may cause our actual results,
performance or achievements to be materially different from any future results,
performances or achievements expressed or implied by the forward-looking
statements. Forward-looking statements may include, but are not limited to
statements about:
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the
progress of preclinical and clinical trials involving our drug
candidates;
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the
progress of our research and development
programs;
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the
benefits to be derived from relationships with our
collaborators;
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the
receipt or anticipated receipt of regulatory clearances and
approvals;
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our
estimates of future revenues and profitability;
and
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our
estimates regarding our capital requirements and our need for additional
financing.
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In some
cases, you can identify forward-looking statements by terms such as “may,”
“will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,”
“believes,” “estimates,” “projects,” “predicts,” “potential” and similar
expressions intended to identify forward-looking statements. These statements
reflect our current views with respect to future events and are based on
assumptions and subject to risks and uncertainties. Given these uncertainties,
you should not place undue reliance on these forward-looking statements. We
discuss many of these risks in greater detail under the heading “Risk Factors”
in the applicable prospectus supplement and in our reports filed from time to
time under the Securities Act and/or the Exchange Act. We encourage
you to read these filings as they are made.
Further,
any forward-looking statement speaks only as of the date on which it is made,
and we undertake no obligation to update any forward-looking statement or
statements to reflect events or circumstances after the date on which such
statement is made or to reflect the occurrence of unanticipated events. New
factors emerge from time to time, and it is not possible for us to predict which
factors will arise. In addition, we cannot assess the impact of each factor on
our business or the extent to which any factor, or combination of factors, may
cause actual results to differ materially from those contained in any
forward-looking statements.
RATIO
OF EARNINGS TO FIXED CHARGES
The
following table shows our ratio of earnings to fixed charges for the periods
indicated.
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Six Months
Ended
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Fiscal Year Ended December 31,
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June 30,
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$ In Thousands, Except Ratio
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2004
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2005
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2006
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2007
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2008
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2009
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Ratio of earnings to fixed
charges(1)
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- |
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- |
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- |
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- |
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- |
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- |
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Deficiency
of earnings to fixed charges(2)
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$ |
(5,687 |
) |
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$ |
(9,517 |
) |
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$ |
(17,857 |
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$ |
(26,608 |
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$ |
(25,231 |
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$ |
(5,738 |
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(1)
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In
each of the periods presented, no earnings were sufficient to cover fixed
charges.
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(2)
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The
deficiency of earnings is equivalent to net income (loss) before tax
benefit (provision) and extraordinary
gain.
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USE
OF PROCEEDS
We will
retain broad discretion over the use of the net proceeds to us from the sale of
our securities offered by this prospectus. Unless we indicate otherwise in the
applicable prospectus supplement, we anticipate that any net proceeds will be
used for working capital and general corporate purposes. We will set forth in
the applicable prospectus supplement our intended use for the net proceeds
received from the sale of securities sold pursuant to that prospectus
supplement.
PLAN
OF DISTRIBUTION
We
may sell the securities covered by this prospectus:
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to
or through one or more underwriters or
dealers;
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directly
to purchasers, or to purchasers through agents;
or
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through
a combination of any of these methods of
sale.
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We may
distribute the securities offered hereby:
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from
time to time in one or more transactions at a fixed price or prices, which
may be changed from time to time;
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at
market prices prevailing at the times of
sale;
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at
prices related to such prevailing market prices;
or
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We will
describe the method of distribution of the securities in the applicable
prospectus supplement.
We may
determine the price or other terms of the securities offered under this
prospectus by use of an electronic auction. We will describe how any auction
will determine the price or any other terms, how potential investors may
participate in the auction and the nature of the obligations of the underwriter,
dealer or agent in the applicable prospectus supplement.
Underwriters,
dealers or agents may receive compensation in the form of discounts, concessions
or commissions from us or our purchasers (as their agents in connection with the
sale of the securities). In addition, underwriters may sell securities to or
through dealers, and those dealers may receive compensation in the form of
discounts, concessions or commissions from the underwriters and/or commissions
from the purchasers for whom they act as agent. These underwriters, dealers or
agents may be considered to be underwriters under the Securities Act. As a
result, discounts, commissions, or profits on resale received by the
underwriters, dealers or agents may be treated as underwriting discounts and
commissions. Each applicable prospectus supplement will identify any such
underwriter, dealer or agent, and describe any compensation received by them
from us. Any initial public offering price and any discounts or concessions
allowed or re-allowed or paid to dealers may be changed from time to
time.
We may
enter into agreements that provide for indemnification against certain civil
liabilities, including liabilities under the Securities Act, or for contribution
with respect to payments made by the underwriters, dealers or agents and to
reimburse these persons for certain expenses.
We may
grant underwriters who participate in the distribution of the securities an
option to purchase additional securities to cover over-allotments, if any, in
connection with the distribution. Underwriters or agents and their associates
may be customers of, engage in transactions with, or perform services for us in
the ordinary course of business.
In
connection with the offering of the securities, certain underwriters and selling
group members and their respective affiliates, may engage in transactions that
stabilize, maintain or otherwise affect the market price of the securities.
These transactions may include stabilization transactions effected in accordance
with Rule 104 of Regulation M promulgated by the SEC pursuant to which these
persons may bid for or purchase securities for the purpose of stabilizing its
market price.
The
underwriters in the offering may engage in overallotment, stabilizing
transactions, short covering transactions and penalty bids in accordance with
rules and regulations under the Securities Exchange Act of 1934, as amended (the
“Exchange Act”). Overallotment involves sales in excess of the offering size,
which create a short position. Stabilizing transactions permit bids to purchase
the underlying security so long as the stabilizing bids do not exceed a
specified maximum. Short covering transactions involve purchases of the
securities in the open market after the distribution is completed to cover short
positions. Penalty bids permit the underwriters to reclaim a selling concession
from a dealer when the securities originally sold by the dealer are purchased in
a covering transaction to cover short positions. Those activities may cause the
price of the securities to be higher than it would otherwise be. If commenced,
the underwriters may discontinue any of these activities at any
time.
DESCRIPTION
OF CAPITAL STOCK
Pursuant
to our certificate of incorporation, as amended and restated to date, our
authorized capital stock consists of 280,000,000 shares, comprised of
250,000,000 shares of common stock, par value $.001 per share, and 30,000,000
shares of preferred stock, par value $.001 per share. As of September 10, 2009,
there were 21,790,964 shares of common stock and no shares of preferred stock
issued and outstanding. Our common stock is traded on the Nasdaq
Capital Market under the symbol “ZIOP”.
The
following description summarizes the material terms of our capital stock. This
summary is, however, subject to the provisions of our certificate of
incorporation and bylaws. For greater detail about our capital stock, please
refer to our certificate of incorporation and bylaws.
Common
Stock
Voting. The holders of our
common stock are entitled to one vote for each outstanding share of common stock
owned by such stockholder on every matter properly submitted to the stockholders
for their vote. Stockholders are not entitled to vote cumulatively
for the election of directors. At any meeting of the stockholders, a
quorum as to any matter shall consist of a majority of the votes entitled to be
cast on the matter, except where a larger quorum is required by law, by our
certificate of incorporation or by our bylaws.
Dividend Rights. Holders of
our common stock are entitled to receive ratably dividends and other
distributions of cash or any other right or property as may be declared by the
registrant’s Board of Directors out of our assets or funds legally available for
such dividends or distributions. The dividend rights of holders of common stock
are subject to the dividend rights of the holders of any series of preferred
stock that may be issued and outstanding from time to time.
Liquidation Rights. In the
event of any voluntary or involuntary liquidation, dissolution or winding up of
our affairs, holders of our common stock would be entitled to share ratably in
our assets that are legally available for distribution to stockholders after
payment of liabilities. If we have any preferred stock outstanding at such time,
the holders of such preferred stock may be entitled to distribution and/or
liquidation preferences that require us to pay the applicable distribution to
the holders of preferred stock before paying distributions to the holders of
common stock.
Conversion, Redemption and
Preemptive Rights. Holders of our common stock have no conversion,
redemption, preemptive, subscription or similar rights.
The
transfer agent and registrar for our common stock is American Stock Transfer and
trust Company.
See
“Certain Provisions of Delaware Law, the Company’s Certificate of Incorporation
and Bylaws and the Company’s Stockholder Rights Plan” for a description of
provisions of the Company’s certificate of incorporation and bylaws which may
have the effect of delaying, deferring or preventing changes in the Company’s
control.
Preferred
Stock
The
following description of preferred stock and the description of the terms of any
particular series of preferred stock that we choose to issue hereunder and that
will be set forth in the related prospectus supplement are not complete. These
descriptions are qualified in their entirety by reference to the certificate of
designation relating to that series. The rights, preferences, privileges and
restrictions of the preferred stock of each series will be fixed by the
certificate of designation relating to that series.
The board
of directors has the authority, without stockholder approval, subject to
limitations prescribed by law, to provide for the issuance of the shares of
preferred stock in one or more series, and by filing a certificate pursuant to
the applicable law of the State of Delaware, to establish from time to time the
number of shares to be included in each such series, and to fix the designation,
powers, preferences and rights of the shares of each series and the
qualifications, limitations or restrictions, including, but not limited to, the
following:
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the
number of shares constituting that
series;
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dividend
rights and rates;
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rights
and terms of redemption (including sinking fund provisions);
and
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rights
of the series in the event of liquidation, dissolution or winding
up.
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All
shares of preferred stock offered hereby will, when issued, be fully paid and
nonassessable and will not have any preemptive or similar rights. Our board of
directors could authorize the issuance of shares of preferred stock with terms
and conditions that could have the effect of discouraging a takeover or other
transaction that might involve a premium price for holders of the shares or
which holders might believe to be in their best interests.
We will
set forth in a prospectus supplement relating to the series of preferred stock
being offered the following items:
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the
title and stated value of the preferred
stock;
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the
number of shares of the preferred stock offered, the liquidation
preference per share and the offering price of the preferred
stock;
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the
dividend rate(s), period(s) and/or payment date(s) or method(s) of
calculation applicable to the preferred
stock;
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whether
dividends are cumulative or non-cumulative and, if cumulative, the date
from which dividends on the preferred stock will
accumulate;
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the
procedures for any auction and remarketing, if any, for the preferred
stock;
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the
provisions for a sinking fund, if any, for the preferred
stock;
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the
provision for redemption, if applicable, of the preferred
stock;
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any
listing of the preferred stock on any securities
exchange;
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the
terms and conditions, if applicable, upon which the preferred stock will
be convertible into common stock, including the conversion price (or
manner of calculation) and conversion
period;
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voting
rights, if any, of the preferred
stock;
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a
discussion of any material and/or special United States federal income tax
considerations applicable to the preferred
stock;
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the
relative ranking and preferences of the preferred stock as to dividend
rights and rights upon the liquidation, dissolution or winding up of our
affairs;
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any
limitations on issuance of any class or series of preferred stock ranking
senior to or on a parity with the class or series of preferred stock as to
dividend rights and rights upon liquidation, dissolution or winding up of
our affairs; and
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any
other specific terms, preferences, rights, limitations or restrictions of
the preferred stock.
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The
transfer agent and registrar for any series of preferred stock will be set forth
in the applicable prospectus supplement.
DESCRIPTION
OF DEBT SECURITIES
This
description is a summary of the material provisions of the debt securities and
the related indenture. We urge you to read the form of indenture filed as an
exhibit to the registration statement of which this prospectus is a part because
the indenture, and not this description, governs your rights as a holder of debt
securities. References in this prospectus to an “indenture” refer to the
particular indenture under which we may issue a series of debt
securities.
General
The terms
of each series of debt securities will be established by or pursuant to a
resolution of our board of directors and set forth or determined in the manner
provided in an officers’ certificate or by a supplemental indenture. Debt
securities may be issued in separate series without limitation as to aggregate
principal amount. We may specify a maximum aggregate principal amount for the
debt securities of any series. The particular terms of each series of debt
securities will be described in a prospectus supplement relating to such series,
including any pricing supplement. The prospectus supplement will set forth
specific terms relating to some or all of the following:
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any
limit on the aggregate principal
amount;
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the
person who shall be entitled to receive interest, if other than the record
holder on the record date;
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the
date the principal will be payable;
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the
interest rate, if any, the date interest will accrue, the interest payment
dates and the regular record dates;
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the
place where payments may be made;
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any
mandatory or optional redemption
provisions;
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if
applicable, the method for determining how the principal, premium, if any,
or interest will be calculated by reference to an index or
formula;
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if
other than U.S. currency, the currency or currency units in which
principal, premium, if any, or interest will be payable and whether we or
the holder may elect payment to be made in a different
currency;
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the
portion of the principal amount that will be payable upon acceleration of
stated maturity, if other than the entire principal
amount;
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any
defeasance provisions if different from those described below under
“Satisfaction and Discharge;
Defeasance”;
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any
conversion or exchange provisions;
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any
obligation to redeem or purchase the debt securities pursuant to a sinking
fund;
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whether
the debt securities will be issuable in the form of a global
security;
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any
subordination provisions, if different from those described below under
“Subordination”;
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any
deletions of, or changes or additions to, the events of default or
covenants; and
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any
other specific terms of such debt
securities.
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Unless
otherwise specified in the prospectus supplement, the debt securities will be
registered debt securities. Debt securities may be sold at a substantial
discount below their stated principal amount, bearing no interest or interest at
a rate which at the time of issuance is below market rates.
Exchange
and Transfer
Debt
securities may be transferred or exchanged at the office of the security
registrar or at the office of any transfer agent designated by us.
We will
not impose a service charge for any transfer or exchange, but we may require
holders to pay any tax or other governmental charges associated with any
transfer or exchange.
In the
event of any potential redemption of debt securities of any series, we will not
be required to:
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issue,
register the transfer of, or exchange, any debt security of that series
during a period beginning at the opening of business 15 days before the
day of mailing of a notice of redemption and ending at the close of
business on the day of the mailing;
or
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register
the transfer of or exchange any debt security of that series selected for
redemption, in whole or in part, except the unredeemed portion being
redeemed in part.
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We may
initially appoint the trustee as the security registrar. Any transfer agent, in
addition to the security registrar, initially designated by us will be named in
the prospectus supplement. We may designate additional transfer agents or change
transfer agents or change the office of the transfer agent. However, we will be
required to maintain a transfer agent in each place of payment for the debt
securities of each series.
Global
Securities
The debt
securities of any series may be represented, in whole or in part, by one or more
global securities. Each global security will:
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be
registered in the name of a depositary that we will identify in a
prospectus supplement;
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be
deposited with the depositary or nominee or custodian;
and
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bear
any required legends.
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No global
security may be exchanged in whole or in part for debt securities registered in
the name of any person other than the depositary or any nominee
unless:
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the
depositary has notified us that it is unwilling or unable to continue as
depositary or has ceased to be qualified to act as
depositary;
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an
event of default is continuing; or
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the
Company executes and delivers to the trustee an officers’ certificate
stating that the global security is
exchangeable.
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As long
as the depositary, or its nominee, is the registered owner of a global security,
the depositary or nominee will be considered the sole owner and holder of the
debt securities represented by the global security for all purposes under the
indenture. Except in the above limited circumstances, owners of beneficial
interests in a global security:
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will
not be entitled to have the debt securities registered in their
names;
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will
not be entitled to physical delivery of certificated debt securities;
and
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will
not be considered to be holders of those debt securities under the
indentures.
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Payments
on a global security will be made to the depositary or its nominee as the holder
of the global security. Some jurisdictions have laws that require that certain
purchasers of securities take physical delivery of such securities in definitive
form. These laws may impair the ability to transfer beneficial interests in a
global security.
Institutions
that have accounts with the depositary or its nominee are referred to as
“participants.” Ownership of beneficial interests in a global security will be
limited to participants and to persons that may hold beneficial interests
through participants. The depositary will credit, on its book-entry registration
and transfer system, the respective principal amounts of debt securities
represented by the global security to the accounts of its
participants.
Ownership
of beneficial interests in a global security will be shown on and effected
through records maintained by the depositary, with respect to participants’
interests, or any participant, with respect to interests of persons held by
participants on their behalf.
Payments,
transfers and exchanges relating to beneficial interests in a global security
will be subject to policies and procedures of the depositary.
The
depositary policies and procedures may change from time to time. Neither we nor
the trustee will have any responsibility or liability for the depositary’s or
any participant’s records with respect to beneficial interests in a global
security.
Payment
and Paying Agent
The
provisions of this paragraph will apply to the debt securities unless otherwise
indicated in the prospectus supplement. Payment of interest on a debt security
on any interest payment date will be made to the person in whose name the debt
security is registered at the close of business on the regular record date.
Payment on debt securities of a particular series will be payable at the office
of a paying agent or paying agents designated by us. However, at our option, we
may pay interest by mailing a check to the record holder. The corporate trust
office will be designated as our sole paying agent.
We may
also name any other paying agents in the prospectus supplement. We may designate
additional paying agents, change paying agents or change the office of any
paying agent. However, we will be required to maintain a paying agent in each
place of payment for the debt securities of a particular series.
All
moneys paid by us to a paying agent for payment on any debt security which
remain unclaimed at the end of two years after such payment was due will be
repaid to us. Thereafter, the holder may look only to us for such
payment.
Consolidation,
Merger and Sale of Assets
Except as
otherwise set forth in the prospectus supplement, we may not consolidate with or
merge into any other person, in a transaction in which we are not the surviving
corporation, or convey, transfer or lease our properties and assets
substantially as an entirety to, any person, unless:
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the
successor, if any, is a U.S. corporation, limited liability company,
partnership, trust or other entity;
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the
successor assumes our obligations on the debt securities and under the
indenture;
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immediately
after giving effect to the transaction, no default or event of default
shall have occurred and be continuing;
and
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certain
other conditions are met.
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Events
of Default
Unless
we inform you otherwise in the prospectus supplement, the indenture will define
an event of default with respect to any series of debt securities as one or more
of the following events:
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(1)
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failure
to pay principal of or any premium on any debt security of that series
when due;
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(2)
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failure
to pay any interest on any debt security of that series for 30 days when
due;
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(3)
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failure
to deposit any sinking fund payment when
due;
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(4)
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failure
to perform any other covenant in the indenture continued for 90 days after
being given the notice required in the
indenture;
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(5)
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our
bankruptcy, insolvency or reorganization;
and
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(6)
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any
other event of default specified in the prospectus
supplement.
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An event
of default of one series of debt securities is not necessarily an event of
default for any other series of debt securities.
If an
event of default, other than an event of default described in clause (5) above,
shall occur and be continuing, either the trustee or the holders of at least 25%
in aggregate principal amount of the outstanding securities of that series may
declare the principal amount of the debt securities of that series to be due and
payable immediately.
If
an event of default described in clause (5) above shall occur, the principal
amount of all the debt securities of that series will automatically become
immediately due and payable. Any payment by us on subordinated debt securities
following any such acceleration will be subject to the subordination provisions
described below under “Subordinated Debt Securities.”
After
acceleration the holders of a majority in aggregate principal amount of the
outstanding securities of that series may, under certain circumstances, rescind
and annul such acceleration if all events of default, other than the non-payment
of accelerated principal, or other specified amount, have been cured or
waived.
Other
than the duty to act with the required care during an event of default, the
trustee will not be obligated to exercise any of its rights or powers at the
request of the holders unless the holders shall have offered to the trustee
reasonable indemnity. Generally, the holders of a majority in aggregate
principal amount of the outstanding debt securities of any series will have the
right to direct the time, method and place of conducting any proceeding for any
remedy available to the trustee or exercising any trust or power conferred on
the trustee.
A holder
will not have any right to institute any proceeding under the indentures, or for
the appointment of a receiver or a trustee, or for any other remedy under the
indentures, unless:
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(1)
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the
holder has previously given to the trustee written notice of a continuing
event of default with respect to the debt securities of that
series;
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(2)
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the
holders of at least 25% in aggregate principal amount of the outstanding
debt securities of that series have made a written request and have
offered reasonable indemnity to the trustee to institute the proceeding;
and
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(3)
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the
trustee has failed to institute the proceeding and has not received
direction inconsistent with the original request from the holders of a
majority in aggregate principal amount of the outstanding debt securities
of that series within 90 days after the original
request.
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Holders
may, however, sue to enforce the payment of principal or interest on any debt
security on or after the due date without following the procedures listed in (1)
through (3) above.
Modification
and Waiver
Except as
provided in the next two succeeding paragraphs, the applicable trustee and we
may make modifications and amendments to the indentures (including, without
limitation, through consents obtained in connection with a tender offer or
exchange offer for, outstanding securities) and may waive any existing default
or event of default (including, without limitation, through consents obtained in
connection with a tender offer or exchange offer for, outstanding securities)
with the consent of the holders of a majority in aggregate principal amount of
the outstanding securities of each series affected by the modification or
amendment.
However,
neither we nor the trustee may make any amendment or waiver without the consent
of the holder of each outstanding security of that series affected by the
amendment or waiver if such amendment or waiver would, among other
things:
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change
the amount of securities whose holders must consent to an amendment,
supplement or waiver;
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change
the stated maturity of any debt
security;
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reduce
the principal on any debt security or reduce the amount of, or postpone
the date fixed for, the payment of any sinking
fund;
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reduce
the principal of an original issue discount security on acceleration of
maturity;
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reduce
the rate of interest or extend the time for payment of interest on any
debt security;
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make
a principal or interest payment on any debt security in any currency other
than that stated in the debt
security;
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impair
the right to enforce any payment after the stated maturity or redemption
date;
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waive
any default or event of default in payment of the principal of, premium or
interest on any debt security (except certain rescissions of
acceleration); or
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waive
a redemption payment or modify any of the redemption provisions of any
debt security;
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Notwithstanding
the preceding, without the consent of any holder of outstanding securities, we
and the trustee may amend or supplement the indentures:
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to
provide for the issuance of and establish the form and terms and
conditions of debt securities of any series as permitted by the
indenture;
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to
provide for uncertificated securities in addition to or in place of
certificated securities;
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to
provide for the assumption of our obligations to holders of any debt
security in the case of a merger, consolidation, transfer or sale of all
or substantially all of our assets;
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to
make any change that does not adversely affect the legal rights under the
indenture of any such holder;
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to
comply with requirements of the Commission in order to effect or maintain
the qualification of an indenture under the Trust Indenture Act;
or
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to
evidence and provide for the acceptance of appointment by a successor
trustee with respect to the debt securities of one or more series and to
add to or change any of the provisions of the indenture as shall be
necessary to provide for or facilitate the administration of the trusts by
more than one Trustee.
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The
consent of holders is not necessary under the indentures to approve the
particular form of any proposed amendment. It is sufficient if such consent
approves the substance of the proposed amendment.
Satisfaction
and Discharge; Defeasance
We may be
discharged from our obligations on the debt securities of any series that have
matured or will mature or be redeemed within one year if we deposit with the
trustee enough cash to pay all the principal, interest and any premium due to
the stated maturity date or redemption date of the debt securities.
Each
indenture contains a provision that permits us to elect:
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to
be discharged from all of our obligations, subject to limited exceptions,
with respect to any series of debt securities then outstanding;
and/or
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to
be released from our obligations under the following covenants and from
the consequences of an event of default resulting from a breach of certain
convenants, including covenants as to payment of taxes and maintenance of
corporate existence.
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To make
either of the above elections, we must deposit in trust with the trustee enough
money to pay in full the principal and interest on the debt securities. This
amount may be made in cash and/or U.S. government obligations. As a condition to
either of the above elections, we must deliver to the trustee an opinion of
counsel that the holders of the debt securities will not recognize income, gain
or loss for federal income tax purposes as a result of the action.
If any of
the above events occurs, the holders of the debt securities of the series will
not be entitled to the benefits of the indenture, except for the rights of
holders to receive payments on debt securities or the registration of transfer
and exchange of debt securities and replacement of lost, stolen or mutilated
debt securities.
Notices
Notices
to holders will be given by mail to the addresses of the holders in the security
register.
Governing
Law
The
indentures and the debt securities will be governed by, and construed under, the
law of the State of New York.
Regarding
the Trustee
The
indenture limits the right of the trustee, should it become a creditor of us, to
obtain payment of claims or secure its claims.
The
trustee is permitted to engage in certain other transactions. However, if the
trustee, acquires any conflicting interest, and there is a default under the
debt securities of any series for which they are trustee, the trustee must
eliminate the conflict or resign.
Subordination
Payment
on subordinated debt securities will, to the extent provided in the indenture,
be subordinated in right of payment to the prior payment in full of all of our
senior indebtedness (except that holders of the notes may receive and retain (i)
permitted junior securities and (ii) payments made from the trust described
under “Satisfaction and Discharge; Defeasance”). Any subordinated debt
securities also are effectively subordinated to all debt and other liabilities,
including lease obligations, if any.
Upon any
distribution of our assets upon any dissolution, winding up, liquidation or
reorganization, the payment of the principal of and interest on subordinated
debt securities will be subordinated in right of payment to the prior payment in
full in cash or other payment satisfactory to the holders of senior
indebtedness. In the event of any acceleration of subordinated debt securities
because of an event of default, the holders of any senior indebtedness would be
entitled to payment in full in cash or other payment satisfactory to such
holders of all senior indebtedness obligations before the holders of
subordinated debt securities are entitled to receive any payment or
distribution, except for certain payments made by the trust described under
“Satisfaction and Discharge; Defeasance.” The indenture requires us or the
trustee to promptly notify holders of designated senior indebtedness if payment
of subordinated debt securities is accelerated because of an event of
default.
We may
not make any payment on subordinated debt securities, including upon redemption
at the option of the holder of any subordinated debt securities or at our
option, if:
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a
default in the payment of the principal, premium, if any, interest, rent
or other obligations in respect of designated senior indebtedness occurs
and is continuing beyond any applicable period of grace (called a “payment
default”); or
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a
default other than a payment default on any designated senior indebtedness
occurs and is continuing that permits holders of designated senior
indebtedness to accelerate its maturity, and the trustee receives notice
of such default (called a “payment blockage notice) from us or any other
person permitted to give such notice under the indenture (called a
“non-payment default”).
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If the
trustee or any holder of the notes receives any payment or distribution of our
assets in contravention of the subordination provisions on subordinated debt
securities before all senior indebtedness is paid in full in cash, property or
securities, including by way of set-off, or other payment satisfactory to
holders of senior indebtedness, then such payment or distribution will be held
in trust for the benefit of holders of senior indebtedness or their
representatives to the extent necessary to make payment in full in cash or
payment satisfactory to the holders of senior indebtedness of all unpaid senior
indebtedness.
In the
event of our bankruptcy, dissolution or reorganization, holders of senior
indebtedness may receive more, ratably, and holders of subordinated debt
securities may receive less, ratably, than our other creditors (including our
trade creditors). This subordination will not prevent the occurrence of any
event of default under the indenture.
We are
not prohibited from incurring debt, including senior indebtedness, under the
indenture. We may from time to time incur additional debt, including senior
indebtedness.
We are
obligated to pay reasonable compensation to the trustee and to indemnify the
trustee against certain losses, liabilities or expenses incurred by the trustee
in connection with its duties under the indenture. The trustee’s claims for
these payments will generally be senior to those of noteholders in respect of
all funds collected or held by the trustee.
Certain
Definitions
“indebtedness”
means:
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(1)
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all
indebtedness, obligations and other liabilities for borrowed money,
including overdrafts, foreign exchange contracts, currency exchange
agreements, interest rate protection agreements, and any loans or advances
from banks, or evidenced by bonds, debentures, notes or similar
instruments, other than any account payable or other accrued current
liability or obligation incurred in the ordinary course of business in
connection with the obtaining of materials or
services;
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(2)
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all
reimbursement obligations and other liabilities with respect to letters of
credit, bank guarantees or bankers’
acceptances;
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(3)
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all
obligations and liabilities in respect of leases required in conformity
with generally accepted accounting principles to be accounted for as
capitalized lease obligations on our balance
sheet;
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(4)
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all
obligations and other liabilities under any lease or related document in
connection with the lease of real property which provides that we are
contractually obligated to purchase or cause a third party to purchase the
leased property and thereby guarantee a minimum residual value of the
leased property to the lessor and our obligations under the lease or
related document to purchase or to cause a third party to purchase the
leased property;
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(5)
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all
obligations with respect to an interest rate or other swap, cap or collar
agreement or other similar instrument or agreement or foreign currency
hedge, exchange, purchase or other similar instrument or
agreement;
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(6)
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all
direct or indirect guaranties or similar agreements in respect of, and our
obligations or liabilities to purchase, acquire or otherwise assure a
creditor against loss in respect of, indebtedness, obligations or
liabilities of others of the type described in (1) through (5)
above;
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(7)
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any
indebtedness or other obligations described in (1) through (6) above
secured by any mortgage, pledge, lien or other encumbrance existing on
property which is owned or held by us;
and
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(8)
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any
and all refinancings, replacements, deferrals, renewals, extensions and
refundings of, or amendments, modifications or supplements to, any
indebtedness, obligation or liability of the kind described in clauses (1)
through (7) above.
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“permitted
junior securities” means (i) equity interests in the Company; or (ii) debt
securities of the Company that are subordinated to all senior indebtedness and
any debt securities issued in exchange for senior indebtedness to substantially
the same extent as, or to a greater extent than the notes are subordinated to
senior indebtedness under the indenture.
“senior
indebtedness” means the principal, premium, if any, interest, including any
interest accruing after bankruptcy, and rent or termination payment on or other
amounts due on our current or future indebtedness, whether created, incurred,
assumed, guaranteed or in effect guaranteed by us, including any deferrals,
renewals, extensions, refundings, amendments, modifications or supplements to
the above. However, senior indebtedness does not include:
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indebtedness
that expressly provides that it shall not be senior in right of payment to
subordinated debt securities or expressly provides that it is on the same
basis or junior to subordinated debt
securities;
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our
indebtedness to any of our majority-owned subsidiaries;
and
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subordinated
debt securities.
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DESCRIPTION
OF WARRANTS
General
We
may issue warrants for the purchase of our debt securities, preferred stock or
common stock, or any combination thereof. Warrants may be issued independently
or together with our debt securities, preferred stock or common stock and may be
attached to or separate from any offered securities. Each series of warrants
will be issued under a separate warrant agreement to be entered into between us
and a bank or trust company, as warrant agent. The warrant agent will act solely
as our agent in connection with the warrants. The warrant agent will not have
any obligation or relationship of agency or trust for or with any holders or
beneficial owners of warrants. This summary of certain provisions of the
warrants is not complete. For the terms of a particular series of warrants, you
should refer to the prospectus supplement for that series of warrants and the
warrant agreement for that particular series.
Debt
warrants
Debt
Warrants
The
prospectus supplement relating to a particular issue of warrants to purchase
debt securities will describe the terms of the debt warrants, including the
following:
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the
title of the debt warrants;
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the
offering price for the debt warrants, if
any;
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the
aggregate number of the debt
warrants;
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the
designation and terms of the debt securities, including any conversion
rights, purchasable upon exercise of the debt
warrants;
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if
applicable, the date from and after which the debt warrants and any debt
securities issued with them will be separately
transferable;
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the
principal amount of debt securities that may be purchased upon exercise of
a debt warrant and the exercise price for the warrants, which may be
payable in cash, securities or other
property;
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the
dates on which the right to exercise the debt warrants will commence and
expire;
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if
applicable, the minimum or maximum amount of the debt warrants that may be
exercised at any one time;
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whether
the debt warrants represented by the debt warrant certificates or debt
securities that may be issued upon exercise of the debt warrants will be
issued in registered or bearer
form;
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information
with respect to book-entry procedures, if any; the currency or currency
units in which the offering price, if any, and the exercise price are
payable;
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if
applicable, a discussion of material U.S. federal income tax
considerations;
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the
antidilution provisions of the debt warrants, if
any;
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the
redemption or call provisions, if any, applicable to the debt
warrants;
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any
provisions with respect to the holder’s right to require us to repurchase
the warrants upon a change in control or similar event;
and
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any
additional terms of the debt warrants, including procedures, and
limitations relating to the exchange, exercise and settlement of the debt
warrants.
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Debt
warrant certificates will be exchangeable for new debt warrant certificates of
different denominations. Debt warrants may be exercised at the corporate trust
office of the warrant agent or any other office indicated in the prospectus
supplement. Prior to the exercise of their debt warrants, holders of debt
warrants will not have any of the rights of holders of the debt securities
purchasable upon exercise and will not be entitled to payment of principal or
any premium, if any, or interest on the debt securities purchasable upon
exercise.
Equity
Warrants
The
prospectus supplement relating to a particular series of warrants to purchase
our common stock or preferred stock will describe the terms of the warrants,
including the following:
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the
title of the warrants;
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the
offering price for the warrants, if
any;
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the
aggregate number of warrants;
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the
designation and terms of the common stock or preferred stock that may be
purchased upon exercise of the
warrants;
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if
applicable, the designation and terms of the securities with which the
warrants are issued and the number of warrants issued with each
security;
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if
applicable, the date from and after which the warrants and any securities
issued with the warrants will be separately
transferable;
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the
number of shares of common stock or preferred stock that may be purchased
upon exercise of a warrant and the exercise price for the
warrants;
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the
dates on which the right to exercise the warrants shall commence and
expire;
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if
applicable, the minimum or maximum amount of the warrants that may be
exercised at any one time;
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the
currency or currency units in which the offering price, if any, and the
exercise price are payable;
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if
applicable, a discussion of material U.S. federal income tax
considerations;
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the
antidilution provisions of the warrants, if
any;
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the
redemption or call provisions, if any, applicable to the
warrants;
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any
provisions with respect to holder’s right to require us to repurchase the
warrants upon a change in control or similar event;
and
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any
additional terms of the warrants, including procedures, and limitations
relating to the exchange, exercise and settlement of the
warrants.
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Holders
of equity warrants will not be entitled:
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to
vote, consent or receive dividends;
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receive
notice as stockholders with respect to any meeting of stockholders for the
election of our directors or any other matter;
or
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exercise
any rights as stockholders of the
Company.
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CERTAIN
PROVISIONS OF DELAWARE LAW,
THE
CERTIFICATE OF INCORPORATION AND BYLAWS
Limitations
on Directors’ Liability
The
Certificate of Incorporation and our bylaws contain provisions indemnifying our
directors and officers to the fullest extent permitted by law. In addition, as
permitted by Delaware law, the Certificate of Incorporation provides that no
director will be liable to us or our stockholders for monetary damages for
breach of certain fiduciary duties as a director. The effect of this provision
is to restrict our rights and the rights of our stockholders in derivative suits
to recover monetary damages against a director for breach of certain fiduciary
duties as a director, except that a director will be personally liable
for:
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the
benefits to be derived from relationships with our
collaborators;
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any
breach of his or her duty of loyalty to the registrant or its
stockholders;
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acts
or omissions not in good faith which involve intentional misconduct or a
knowing violation of law;
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the
payment of dividends or the redemption or purchase of stock in violation
of Delaware law; or
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any
transaction from which the director derived an improper personal
benefit.
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This
provision does not affect a director’s liability under the federal securities
laws.
To the
extent that our directors, officers and controlling persons are indemnified
under the provisions contained in the Certificate of Incorporation, Delaware law
or contractual arrangements against liabilities arising under the Securities
Act, we have been advised that in the opinion of the Securities and Exchange
Commission such indemnification is against public policy as expressed in the
Securities Act, and is therefore unenforceable.
Provisions
that May Have an Anti-Takeover Effect
Certain
provisions set forth in our certificate of incorporation, bylaws and in Delaware
law, which are summarized below, are intended to enhance the likelihood of
continuity and stability in the composition of our Board of Directors and in the
policies formulated by our Board of Directors and to discourage certain types of
transactions that may involve an actual or threatened change of control. In that
regard, these provisions are designed to reduce our vulnerability to an
unsolicited acquisition proposal. The provisions also are intended to discourage
certain tactics that may be used in proxy fights. However, such provisions could
have the effect of discouraging others from making tender offers for our shares
and, as a consequence, they also may inhibit fluctuations in the market price of
our common stock that could result from actual or rumored takeover attempts.
Such provisions also may have the effect of preventing changes in our
management.
Blank Check Preferred Stock.
Our certificate of incorporation contains provisions that permit our Board of
Directors to issue, without any further vote or action by the stockholders, up
to 30,000,000 shares of preferred stock in one or more series and, with respect
to each such series, to fix the number of shares constituting the series and the
designation of the series, the voting powers (if any) of the shares of the
series, and the preferences and relative, participating, optional and other
special rights, if any, and any qualifications, limitations or restrictions, of
the shares of such series. As a result, our Board of Directors could authorize
the issuance of shares of preferred stock with terms and conditions that could
have the effect of delaying, deferring or preventing a transaction or a change
in control that might involve a premium price for holders of the registrant’s
common stock or otherwise be in their best interest.
Special Meetings of
Stockholders. Our bylaws provide that special meetings of stockholders
may be called only by the Board of Directors. Stockholders are not permitted to
call a special meeting of stockholders or to require that the Board of Directors
call such a special meeting.
Delaware
Takeover Statute.
In
general, Section 203 of the Delaware General Corporation Law prohibits a
Delaware corporation that is a public company from engaging in any “business
combination” (as defined below) with any “interested stockholder” (defined
generally as an entity or person beneficially owning 15% or more of the
outstanding voting stock of the corporation and any entity or person affiliated
with such entity or person) for a period of three years following the date that
such stockholder became an interested stockholder, unless: (1) prior to such
date, the board of directors of the corporation approved either the business
combination or the transaction that resulted in the stockholder becoming an
interested stockholder; (2) on consummation of the transaction that resulted in
the stockholder becoming an interested stockholder, the interested stockholder
owned at least 85% of the voting stock of the corporation outstanding at the
time the transaction commenced, excluding for purposes of determining the number
of shares outstanding those shares owned (x) by persons who are directors and
also officers and (y) by employee stock plans in which employee participants do
not have the right to determine confidentially whether shares held subject to
the plan will be tendered in a tender or exchange offer; or (3) on or subsequent
to such date, the business combination is approved by the board of directors and
authorized at an annual or special meeting of stockholders, and not by written
consent, by the affirmative vote of at least 662/3% of
the outstanding voting stock that is not owned by the interested
stockholder.
Section
203 of the Delaware General Corporation Law defines “business combination” to
include: (1) any merger or consolidation involving the corporation and the
interested stockholder; (2) any sale, transfer, pledge or other disposition of
10% or more of the assets of the corporation involving the interested
stockholder; (3) subject to certain exceptions, any transaction that results in
the issuance or transfer by the corporation of any stock of the corporation to
the interested stockholder; (4) any transaction involving the corporation that
has the effect of increasing the proportionate share of the stock of any class
or series of the corporation beneficially owned by the interested stockholder;
or (5) the receipt by the interested stockholder of the benefit of any loans,
advances, guarantees, pledges or other financial benefits provided by or through
the corporation.
WHERE
YOU CAN FIND MORE INFORMATION
We are a
reporting company and file annual, quarterly and current reports, proxy
statements and other information with the SEC. You may read and copy these
reports, proxy statements and other information at the SEC’s public reference
room at 100 F. Street, N.E., Washington, D.C. 20549 or at the SEC’s other public
reference facilities. Please call the SEC at 1-800-SEC-0330 for more information
about the operation of the public reference rooms. You can request copies of
these documents by writing to the SEC and paying a fee for the copying
costs. In addition, the SEC maintains an Internet site at http://www.sec.gov that contains
reports, proxy and information statements and other information regarding
issuers that file electronically with the SEC. Our SEC filings are
available on the SEC’s Internet site.
INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
We are
allowed to incorporate by reference information contained in documents that we
file with the SEC. This means that we can disclose important information to you
by referring you to those documents and that the information in this prospectus
is not complete and you should read the information incorporated by reference
for more detail. We incorporate by reference in two ways. First, we list certain
documents that we have already filed with the SEC. The information in these
documents is considered part of this prospectus. Second, the information in
documents that we file in the future will update and supersede the current
information in, and incorporated by reference in, this prospectus.
We
incorporate by reference the documents listed below and any future filings we
will make with the SEC under Section 13(a), 13(c), 14 or 15(d) of the
Securities Exchange Act of 1934, as amended, or the Exchange Act (other than
information furnished in Current Reports on Form 8-K filed under Item 2.02
or 7.01 of such form):
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Annual
Report on Form 10-K for the fiscal year ended December 31, 2008,
filed on March 23, 2009;
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Quarterly
Reports on Form 10-Q for the quarters ended March 31, 2009 and
June 30, 2009, filed on May 15, 2009 and August 14, 2009,
respectively;
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Current
Reports on Form 8-K filed on June 1, 2009 and June 4, 2009;
and
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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.
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We will
provide to each person, including any beneficial owner, to whom a prospectus is
delivered, a copy of any or all of the information that has been incorporated by
reference in this prospectus but not delivered with this prospectus. You may
request a copy of this information at no cost, by writing or telephoning us at
the following address or telephone number:
ZIOPHARM
Oncology, Inc.
1180
Avenue of the Americas, 19th Floor
New York,
NY 10036
Attention:
President
Telephone:
(646) 214-0700
You
should rely only on the information incorporated by reference or provided in
this prospectus or any supplement. We have not authorized anyone else to provide
you with different information. The selling stockholders will not make an offer
of these shares in any state where the offer is not permitted. You should not
assume that the information in this prospectus or any supplement is accurate as
of any date other than the date on the front of these documents.
LEGAL
MATTERS
The
validity of the securities offered hereby will be passed upon by Maslon Edelman
Borman & Brand, LLP, Minneapolis, Minnesota.
EXPERTS
The
balance sheets of ZIOPHARM Oncology, Inc. as of December 31, 2008 and 2007 and
the related statements of operations, changes in convertible preferred stock and
stockholders’ equity (deficit) and cash flows for each of the years in the
three-year period ended December 31, 2008 and for the period from September 9,
2003 (date of inception) through December 31, 2008, included in this prospectus,
have been included herein in reliance on the report, dated March 16, 2009, of
Vitale, Caturano & Company, P.C., (whose name has been changed to Caturano
and Company, P.C. effective May 1, 2009) independent registered public
accounting firm, given on the authority of that firm as experts in auditing and
accounting.