Unassociated Document
As
filed with the Securities and Exchange Commission June 30,
2006
|
Registration
No. 333-129680
|
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
POST
EFFECTIVE AMENDMENT NO. 2
ON
FORM S-3** TO FORM SB-2
REGISTRATION
STATEMENT UNDER THE SECURITIES ACT OF 1933
________________________________
ZIOPHARM
Oncology, Inc.
(Exact
name of registrant as specified in its charter)
Delaware
(State
or jurisdiction
of
incorporation or organization)
|
|
84-1475642
(I.R.S.
Employer
Identification
No.)
|
1180
Avenue of the Americas, 19th Floor
New
York, NY 10036
(646)
214-0700
(Address
and telephone number of registrant’s principal executive offices and
principal place of business)
|
Dr.
Jonathan Lewis
Chief
Executive Officer
ZIOPHARM
Oncology, Inc.
1180
Avenue of the Americas, 19th Floor
New
York, NY 10036
Telephone:
(646) 214-0700
Facsimile:
(646) 214-0711
(Name,
address and telephone number of agent for service)
|
|
Copies
to:
William
M. Mower, Esq.
Alan
M. Gilbert, Esq.
Maslon
Edelman Borman & Brand, LLP
90
South 7th Street, Suite 3300
Minneapolis,
Minnesota 55402
Telephone:
(612) 672-8200
Facsimile:
(612) 642-8381
|
Approximate
date of proposed sale to the public: From
time
to time after the effective date of this Registration Statement, as shall
be
determined by the selling stockholders identified herein.
If
the
only securities being registered on this Form are being offered pursuant
to
dividend or interest reinvestment plans, please check the following box.
o
If
any of
the securities being registered on this Form are to be offered on a delayed
or
continuous basis pursuant to Rule 415 under the Securities Act of 1933, other
than securities offered only in connection with dividend or interest
reinvestment plans, check the following box: x
If
this
Form is filed to register additional securities for an offering pursuant
to Rule
462(b) under the Securities Act, please check the following box and list
the
Securities Act registration statement number of the earlier effective
registration statement for the same offering. o_________
If
this
Form is a post-effective amendment filed pursuant to Rule 462(c) under the
Securities Act, check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the
same
offering. o
_________
If
this
Form is a registration statement pursuant to General Instruction I.D. or
a
post-effective amendment thereto that shall become effective upon filing
with
the Commission pursuant to Rule 462(e) under the Securities Act, check the
following box. o
If
this
Form is a post-effective amendment to a registration statement filed pursuant
to
General Instruction I.D. filed to register additional securities or additional
classes of securities pursuant to Rule 413(b)under the Securities Act, check
the
following box. o
The
Registrant hereby amends this Registration Statement on such date or dates
as
may be necessary to delay its effective date until the Registrant shall file
a
further amendment which specifically states that this Registration Statement
shall thereafter become effective in accordance with Section 8(a) of the
Securities Act of 1933 or until the Registration Statement shall become
effective on such date as the Commission, acting pursuant to said Section
8(a),
may determine.
**
Filed
as a Post-effective Amendment on Form S-3 to such Form SB-2 Registration
Statement pursuant to the provisions of Rule 401(e)
Subject
to completion, dated June 30, 2006
ZIOPHARM
Oncology, Inc.
7,140,702
Shares
Common
Stock
The
selling stockholders identified on pages 15-20 of this prospectus are
offering on a resale basis a total of 7,140,702 shares of our common stock,
of
which 482,407 shares are issuable upon the exercise of outstanding
warrants. We will not receive any proceeds from the sale of these shares by
the
selling stockholders.
Our
common stock is quoted on the Over-the-Counter Bulletin Board under the symbol
“ZIOP.” On June 26, 2006, the last sale price for our common stock as
reported on the OTC Bulletin Board was $5.20.
The
securities offered by this prospectus involve a high degree of
risk.
See
“Risk Factors” beginning on page 6.
Neither
the Securities and Exchange Commission nor any state securities commission
has
approved or disapproved these securities or determined that this prospectus
is
truthful or complete. A representation to the contrary is a criminal
offense.
The
date
of this Prospectus
is ,
2006.
Table
of Contents
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Page
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Prospectus
Summary
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3
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|
Risk
Factors
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6
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Note
Regarding Forward Looking Statements
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14
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Use
of Proceeds
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14
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Selling
Stockholders
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15
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Plan
of Distribution
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22
|
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Disclosure
of Commission Position on Indemnification for Securities Act
Liabilities
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24
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About
This Prospectus
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24
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Where
You Can Find More Information
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24
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|
Validity
of Common Stock
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25
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|
Experts
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25
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PROSPECTUS
SUMMARY
This
summary provides a brief overview of the key aspects of this offering. 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.
Our
Company
We
are a
biopharmaceutical company that is seeking to develop and commercialize a
diverse, risk-sensitive portfolio of in-licensed cancer drugs that address
unmet
medical needs. Our management and advisors are focused on licensing and
developing proprietary drug candidate families that are related to cancer
therapeutics on the market and where the application of new biology and our
drug
development expertise will facilitate clinical development, risk management
and
expedited regulatory approval. We expect to commercialize our products on our
own in North America but recognize that promising clinical trial results in
cancers with a high incidence and prevalence might also be addressed in a
commercial partnership with one or more other companies with the requisite
financial resources. Currently, we are in Phase I and Phase I/II studies for
two
product candidates known as ZIO-101 and ZIO-201. We currently intend to continue
with clinical development of ZIO-101 for advanced myeloma and ZIO-201 for
advanced sarcoma. None of our product candidates have been approved by the
United States Food and Drug Administration (the “FDA”) or any other regulatory
body. Further, we have not received any commercial revenues to date, and until
we receive the necessary approvals from the FDA or a similar foreign regulatory
authority, we will not have any commercial revenues.
·
ZIO-101
is an organic arsenic compound covered by issued U.S. patents and applications
internationally. A form of commercially available inorganic arsenic (arsenic
trioxide (Trisenox®) or ATO) has been approved for the treatment of acute
promyelocytic leukemia (APL), a precancerous condition, and is on the compendia
listing for the therapy of multiple myeloma as well as having been studied
for
the treatment of various other cancers. Nevertheless, ATO has been shown to
be
toxic to the heart, liver and brain, limiting its use as an anti-cancer agent.
Inorganic arsenic has also been shown to cause cancer of the skin and lung
in
humans. The toxicity of arsenic generally is correlated to its accumulation
in
organs and tissues. Our preclinical and Phase I studies to date have
demonstrated that ZIO-101 (and organic arsenic in general) is considerably
less
toxic than inorganic arsenic, particularly with regard to heart toxicity. In
vitro testing of ZIO-101 using the National Cancer Institute’s human cancer cell
panel detected activity against lung, colon, brain, melanoma, ovarian and kidney
cancer. Moderate activity was detected against breast and prostate cancer.
In
addition to solid tumors, in vitro testing in both the National Cancer
Institute’s cancer cell panel and in vivo testing in a leukemia animal model
demonstrated substantial activity against hematological cancers (cancers of
the
blood and blood-forming tissues) such as leukemia, lymphoma, myelodysplastic
syndromes and multiple myeloma.
Phase
I
testing of ZIO-101 is ongoing with two safety and dose finding studies at the
University of Texas M. D. Anderson Cancer Center. The Company has seen
encouraging signs of clinical activity in both of these studies including impact
on blood and bone marrow blast cells in patients with acute myelogenous leukemia
(AML) and including one patient with metastatic renal cell carcinoma where
metastases to the brain resolved. The Company recently initiated a phase I/II
advanced multiple myeloma (SGL2001) study to be conducted in the U.S., Canada
and Europe designed to determine maximum tolerated dose and to assess clinical
activity in this specific indication. The Company expects to pursue registration
in the U.S. for the treatment of advanced multiple myeloma with a potentially
pivotal trial to begin in 2007.
|
· |
ZIO-201,
or isophosphoramide mustard (IPM), is a proprietary stabilized
metabolite
of ifosfamide that is also related to cyclophosphamide. A patent
application for pharmaceutical composition has been filed.
Cyclophosphamide and ifosfamide are alkylating agents. The Company
believes cyclophosphamide is the most widely used alkylating agent
in
cancer therapy and is used to treat breast cancer and non-Hodgkin’s
lymphoma. Ifosfamide has been shown to be effective in high dose
by
itself, or in combination in treating sarcoma and lymphoma. Although
ifosfamide-based treatment generally represents the standard of
care for
sarcoma, it is not licensed for this indication by the FDA. Our
preclinical studies have shown that, in animal and laboratory models,
IPM
evidences activity against leukemia and solid tumors. These studies
also
indicate that ZIO-201 has a better pharmacokinetic and safety profile
than
ifosfamide or cyclophosphamide, offering the possibility of safer
and more
efficacious therapy with ZIO-201. Ifosfamide is metabolized to
IPM. In
addition to IPM, another metabolite of ifosfamide is acrolein,
which is
toxic to the kidneys and bladder. The presence of acrolein can
mandate the
administration of a protective agent called mesna, which is inconvenient
and expensive. Chloroacetaldehyde is another metabolite of ifosfamide
and
is toxic to the central nervous system, causing “fuzzy brain” syndrome for
which there is currently no protective measure. Similar toxicity
concerns
pertain to high-dose cyclophosphamide, which is widely used in
bone marrow
and blood cell transplantation. Because ZIO-201 is independently
active—without acrolein or chloroacetaldehyde metabolites—the Company
believes that the administration of ZIO-201 may avoid many of the
toxicities of ifosfamide and cyclophosphamide without compromising
efficacy. In addition to anticipated lower toxicity, ZIO-201 (and
without
the coadministration of mesna) may have other advantages over ifosfamide.
In preclinical studies, ZIO-201 likely cross-links DNA differently
than
ifosfamide or cyclophosphamide metabolites, resulting in a different
activity profile. Moreover, in some instances ZIO-201 appears to
show
activity in ifosfamide- and/or cyclophosphamide-resistant cancer
cells.
|
Phase
I
testing of ZIO-201 is ongoing at two sites in the U.S. (Karmanos Cancer Center
at Wayne State University in Detroit and Premiere Oncology in Los Angeles).
IPM
has been administered without the “uroprotectant” mesna and the toxicities
associated with acrolein and chloroacetaldehyde have not been observed. Kidney
toxicity seen with ifosfamide has occurred in the higher dose cohorts. One
patient with advanced mesothelioma had stable disease following 18 cycles of
therapy with ZIO-201 as a single agent. The Company recently initiated a phase
I/II trial in advanced sarcoma at the University of Texas M. D. Anderson Cancer
Center (the “MDACC”). Additional studies in patients with advanced sarcoma will
begin shortly in the U.S. and plans for a phase I/II study in pediatric sarcoma
are well advanced. The Company expects to pursue registration in the U.S. for
the treatment of advanced sarcoma with a potentially pivotal trial to begin
in
2007.
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 Easy Web
was the legal acquirer in the transaction, ZIOPHARM, Inc. became the registrant
with the Securities and Exchange Commission because under generally accepted
accounting principles the transaction was accounted for as a reverse
acquisition. Accordingly, the historical financial statements of ZIOPHARM,
Inc.
have become 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 ZIO-101 and
ZOI-201 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 are urged to
carefully review and consider the section entitled “Risk Factors” beginning on
page 6 of this prospectus.
The
Offering
The
shares offered by this prospectus were previously covered by our prospectus
dated April 14, 2006, as supplemented to date, which originally covered the
resale of an aggregate of 7,462,095 shares of our common stock by the selling
stockholders identified in such prospectus, of which 482,407 shares are issuable
upon the exercise of outstanding warrants. The selling stockholders identified
on pages 15-20 of this prospectus are offering an aggregate of 7,140,702 shares
of our common stock, including 482,407 shares issuable upon the exercise of
outstanding warrants. The shares offered by such selling stockholders reflect
those shares of our common stock remaining unsold by the selling stockholders
identified in our April 14, 2006 prospectus.
Common
stock offered
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|
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7,140,702
shares
|
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Common
stock outstanding before the offering(1)
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15,264,248
shares
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Common
stock outstanding after the offering(1)(2)
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15,746,655
shares
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Common
Stock OTC Bulletin Board symbol
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|
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ZIOP
|
|
(1)
|
Based
on the number of shares outstanding as of June 26, 2006, not
including shares issuable upon exercise of various warrants and options
to purchase common stock.
|
(2)
|
Assumes
the issuance of all shares offered hereby that are issuable upon
exercise
of outstanding warrants.
|
RISK
FACTORS
An
investment in our common stock is very risky. You may lose the entire amount
of
your investment. Prior to making an investment decision, you should carefully
review this entire prospectus and consider the following risk
factors:
We
currently have no product revenues and will need to raise additional capital
to
operate our business.
To
date,
we have generated no product revenues. Until and unless we receive approval
from
the FDA and/or other regulatory authorities for our product candidates, we
cannot sell our drugs and will not have product revenues. Currently, our only
product candidates are ZIO-101(organic arsenic) and ZIO-201 (isophosphoramide
mustard), and they are not approved by the FDA for sale.
We
will need to seek additional sources of financing which may not be available
on
favorable terms, if at all.
As
of
March 31, 2006, we had incurred approximately $18.6 million of cumulative net
losses and had approximately $5.6 million of cash, cash equivalents and
short-term investments. Our consolidated financial statements as of December
31,
2005 were prepared under the assumption that we will continue as a going concern
for the year ending December 31, 2006. The Company’s independent registered
public accounting firm, Vitale, Caturano & Company, Ltd., issued a report
dated March 9, 2006 that included an explanatory paragraph referring to our
significant operating losses and expressing substantial doubt in its ability
to
continue as a going concern (See Note (1) in the Notes to Consolidated Financial
Statements) without additional capital becoming available. As of May 3, 2006,
and after receiving the proceeds from our May 3, 2006 offering of common stock
and warrants, we had approximately $39.2 million of cash, cash equivalents
and
short-term investments. Although we expect that the proceeds from this offering
will provide us with sufficient cash to fund our operations into the first
quarter of 2008, our ability to continue as a going concern beyond that time
is
dependent upon our ability to obtain additional equity or debt financing, attain
further operating efficiencies and, ultimately, to generate revenue. Our
financial statements do not include any adjustments that might result from
the
outcome of this uncertainty. Although we expect our cash on-hand to fund our
operations into the first quarter of 2008, changes may occur that would consume
our existing capital prior to that time, including the progress of our research
and development efforts, changes in governmental regulation and acquisitions
of
additional product candidates. If we do not succeed in raising additional funds
on acceptable terms, we may be unable to complete planned preclinical and
clinical trials or obtain approval of any product candidates from the FDA and
other regulatory authorities. In addition, we could be forced to discontinue
product development, reduce or forego sales and marketing efforts or forego
attractive business opportunities. Any additional sources of financing will
likely involve the issuance of our equity securities, which will have a dilutive
effect on our existing stockholders.
We
are not currently profitable and may never become profitable.
We
have a
history of losses and expect to incur substantial losses and negative operating
cash flow for the foreseeable future, and we may never achieve or maintain
profitability. Even if we succeed in developing and commercializing one or
more
product candidates, we expect to incur substantial losses for the foreseeable
future and may never become profitable. We expect also to continue to incur
significant operating and capital expenditures and anticipate that our expenses
will increase substantially in the foreseeable future as we:
·
|
Continue
to undertake preclinical development and clinical trials for product
candidates;
|
·
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Scale
up the formulation and manufacturing of our product candidates;
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·
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Seek
regulatory approvals for product candidates;
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·
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Implement
additional internal systems and infrastructure; and
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·
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Hire
additional personnel and expand office space.
|
We
also
expect to experience negative cash flow for the foreseeable future as we fund
our operating losses and capital expenditures. This may result in a negative
impact on the value of our common stock.
We
have a limited operating history upon which to base an investment decision.
Prior
to
the Merger, ZIOPHARM, Inc. was a development-stage company that was incorporated
in September 2003. To date, we have not demonstrated an ability to perform
the
functions necessary for the successful commercialization of any product
candidates. The successful commercialization of any product candidates will
require us to perform a variety of functions, including:
·
|
Continuing
to undertake preclinical development and clinical
trials;
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·
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Participating
in regulatory approval processes;
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·
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Formulating
and manufacturing products; and
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·
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Conducting
sales and marketing activities.
|
Our
operations have been limited to organizing and staffing our Company, acquiring,
developing and securing our proprietary product candidates, undertaking
preclinical trials and clinical trials of our product candidates ZIO-101 and
ZIO-201, and manufacturing ZIO-101 and ZIO- 201. These operations provide a
limited basis for you to assess our ability to commercialize our product
candidates and the advisability of investing in our securities.
We
may not obtain the necessary U.S. or worldwide regulatory approvals to
commercialize any product candidate.
We
may
not be able to obtain the approvals necessary to commercialize our product
candidates, ZIO-101 and ZIO-201, or any product candidate that we may acquire
or
develop in the future for commercial sale. We will need FDA approval to
commercialize our product candidates in the U.S. and approvals from regulatory
authorities in foreign jurisdictions equivalent to the FDA to commercialize
our
product candidates in those jurisdictions. In order to obtain FDA approval
of
any product candidate, we must submit to the FDA a New Drug Application (NDA),
demonstrating that the product candidate is safe for humans and effective for
its intended use. This demonstration requires significant research and animal
tests, which are referred to as preclinical studies, as well as human tests,
which are referred to as clinical trials. Satisfaction of the FDA’s regulatory
requirements typically takes many years, depending upon the type, complexity
and
novelty of the product candidate, and will require substantial resources for
research, development and testing. We cannot predict whether our research,
development, and clinical approaches will result in drugs that the FDA considers
safe for humans and effective for their intended uses. The FDA has substantial
discretion in the drug approval process and may require us to conduct additional
preclinical and clinical testing or to perform post-marketing studies. The
approval process may also be delayed by changes in government regulation, future
legislation or administrative action or changes in FDA policy that occur prior
to or during our regulatory review. Delays in obtaining regulatory approvals
may:
·
|
Delay
commercialization of, and our ability to derive product revenues
from, our
product candidates;
|
·
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Impose
costly procedures on us; and
|
·
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Diminish
any competitive advantages that we may otherwise enjoy.
|
Even
if
we comply with all FDA requests, the FDA may ultimately reject one or more
of
our NDAs. We cannot be sure that we will ever obtain regulatory clearance for
our product candidates, ZIO-101 and ZIO-201. Failure to obtain FDA approval
of
our product candidates will severely undermine our business by leaving us
without a saleable product, and therefore without any potential revenue source,
until another product candidate can be developed. There is no guarantee that
we
will ever be able to develop or acquire another product candidate.
In
foreign jurisdictions, we similarly must receive approval from applicable
regulatory authorities before we can commercialize any drugs. Foreign regulatory
approval processes generally include all of the risks associated with the FDA
approval procedures described above.
Our
product candidates are in early stages of clinical trials, and we cannot be
certain when we will be able to file an NDA with the FDA.
Our
product candidates, ZIO-101 and ZIO-201, are in early stages of development
and
require extensive clinical testing. Notwithstanding our current clinical trial
plans for each of our existing product candidates, we may not be able to
commence additional trials or see results from these trials within our
anticipated timelines. As such, we cannot predict with any certainty if or when
we might submit an NDA for regulatory approval of our product candidates or
whether such an NDA will be accepted.
Clinical
trials are very expensive, time-consuming and difficult to design and implement.
Human
clinical trials are very expensive and difficult to design and implement, in
part because they are subject to rigorous regulatory requirements. The clinical
trial process is also time consuming. We estimate that clinical trials of our
product candidates will take at least several years to complete. Furthermore,
failure can occur at any stage of the trials, and we could encounter problems
that cause us to abandon or repeat clinical trials. The commencement and
completion of clinical trials may be delayed by several factors,
including:
·
|
Unforeseen
safety issues;
|
·
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Determination
of dosing issues;
|
·
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Lack
of effectiveness during clinical trials;
|
·
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Slower
than expected rates of patient recruitment;
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·
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Inability
to monitor patients adequately during or after treatment; and
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·
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Inability
or unwillingness of medical investigators to follow our clinical
protocols.
|
We
are
hopeful that we may be able to obtain “Fast Track” and or “Orphan Drug” status
from the FDA for one or more of our product candidates. Fast Track allows the
FDA to facilitate development and expedite review of drugs that treat serious
and life-threatening conditions so that an approved product can reach the market
expeditiously. Fast Track status does not apply to a product alone, but applies
to a combination of a product and the specific indications for which it is
being
studied. Therefore, it is a drug’s development program for a specific indication
that receives Fast Track designation. Orphan Drug status promotes the
development of products that demonstrate the promise for the diagnosis and
treatment of one disease or condition and affords certain financial and market
protection benefits to successful applicants. However, there is no guarantee
that any of our product candidates will be granted Fast Track or Orphan Drug
status by the FDA or that, even if such product candidate is granted such
status, the product candidate’s clinical development and regulatory approval
process will not be delayed or will be successful.
In
addition, we or the FDA may suspend our clinical trials at any time if it
appears that we are exposing participants to unacceptable health risks or if
the
FDA finds deficiencies in our IND submission or in the conduct of these trials.
Therefore, we cannot predict with any certainty the schedule for future clinical
trials.
The
results of our clinical trials may not support our product candidate claims.
Even
if
our clinical trials are completed as planned, we cannot be certain that their
results will support approval of our product candidates. Success in preclinical
testing and early clinical trials does not ensure that later clinical trials
will be successful, and we cannot be sure that the results of later clinical
trials will replicate the results of prior clinical trials and preclinical
testing. The clinical trial process may fail to demonstrate that our product
candidates are safe for humans and effective for indicated uses. This failure
would cause us to abandon a product candidate and may delay development of
other
product candidates. Any delay in, or termination of, our clinical trials will
delay the filing of our NDAs with the FDA and, ultimately, our ability to
commercialize our product candidates and generate product revenues. In addition,
our clinical trials involve small patient populations. Because of small sample
size, the results of these clinical trials may not be indicative of future
results.
Even
if
the FDA approves our product candidates, physicians and patients may not accept
and use them. Acceptance and use of our products will depend upon a number
of
factors including:
·
|
Perceptions
by members of the health care community, including physicians, regarding
the safety and effectiveness of our drugs;
|
·
|
Cost-effectiveness
of our products relative to competing products;
|
·
|
Availability
of reimbursement for our products from government or other healthcare
payers; and
|
·
|
Effectiveness
of marketing and distribution efforts by us and our licensees and
distributors, if any.
|
Because
we expect sales of our current product candidates, if approved, to generate
substantially all of our product revenues for the foreseeable future, the
failure of a drug to find market acceptance would harm our business and could
require us to seek additional financing in order to fund the development of
future product candidates.
Our
drug development program materially depends upon third-party researchers who
are
outside our control.
We
materially rely upon independent investigators and collaborators, such as
universities and medical institutions, to conduct our preclinical and clinical
trials under agreements with us. These collaborators are not our employees
and
we cannot control the amount or timing of resources that they devote to our
programs. These investigators may not assign as great a priority to our programs
or pursue them as diligently as we would if we were undertaking such programs
ourselves. If outside collaborators fail to devote sufficient time and resources
to our drug development programs, or if their performance is substandard, the
approval of our FDA applications, if any, and our introduction of new drugs,
if
any, will be delayed. These collaborators may also have relationships with
other
commercial entities, some of whom may compete with us. If our collaborators
assist our competitors to our detriment, our competitive position would be
harmed.
We
rely exclusively on third parties to formulate and manufacture our product
candidates.
We
do not
have experience in drug formulation or manufacturing and do not intend to
establish our own manufacturing facilities. We lack the resources and expertise
to formulate or manufacture our own product candidates. We currently are
contracting for the commercial scale manufacture of our product candidates.
We
intend to contract with one or more manufacturers to manufacture, supply, store
and distribute drug supplies for our clinical trials. If a product candidate
we
develop or acquire in the future receives FDA approval, we will rely on one
or
more third-party contractors to manufacture our drugs. Our anticipated future
reliance on a limited number of third-party manufacturers exposes us to the
following risks:
·
|
We
may be unable to identify manufacturers on acceptable terms or at
all
because the number of potential manufacturers is limited and the
FDA must
approve any replacement contractor. This approval would require new
testing and compliance inspections. In addition, a new manufacturer
would
have to be educated in, or develop substantially equivalent processes
for,
production of our products after receipt of FDA approval, if any.
|
·
|
Our
third-party manufacturers might be unable to formulate and manufacture
our
drugs in the volume and of the quality required to meet our clinical
needs
and commercial needs, if any.
|
·
|
Our
future contract manufacturers may not perform as agreed or may not
remain
in the contract manufacturing business for the time required to supply
our
clinical trials or to successfully produce, store and distribute
our
products.
|
·
|
Drug
manufacturers are subject to ongoing periodic unannounced inspection
by
the FDA, the Drug Enforcement Administration (the “DEA”), and
corresponding state agencies to ensure strict compliance with good
manufacturing practices and other government regulations and corresponding
foreign standards. We do not have control over third-party manufacturers’
compliance with these regulations and standards.
|
·
|
If
any third-party manufacturer makes improvements in the manufacturing
process for our products, we may not own, or may have to share, the
intellectual property rights to the innovation.
|
Each
of
these risks could delay our clinical trials, the approval, if any, of our
product candidates by the FDA or the commercialization of our product candidates
or result in higher costs or deprive us of potential product
revenues.
We
do not have experience selling, marketing or distributing products and we have
no internal capability to do so.
We
currently have no marketing, sales or distribution capabilities. If and when
we
become reasonably certain that we will be able to commercialize our current
or
future products, we anticipate allocating resources to the marketing, sales
and
distribution of our proposed products in North America, however, we cannot
assure that we will be able to market, sell and distribute our products
successfully. Our future success also may depend, in part, on our ability to
enter into and maintain collaborative relationships for such capabilities and
to
encourage the collaborator’s strategic interest in the products under
development and such collaborator’s ability to successfully market and sell any
such products. Although we intend to pursue certain collaborative arrangements
regarding the sale and marketing of our products, there can be no assurance
that
we will be able to establish or maintain our own sales operations or affect
collaborative arrangements, or that if we are able to do so, our collaborators
will have effective sales forces. There can also be no assurance that we will be
able to establish or maintain relationships with third party collaborators
or
develop in-house sales and distribution capabilities. To the extent that we
depend on third parties for marketing and distribution, any revenues we receive
will depend upon the efforts of such third parties, and there can be no
assurance that such efforts will be successful. In addition, there can also
be
no assurance that we will be able to market and sell our products in the United
States or overseas.
If
we cannot compete successfully for market share against other drug companies,
we
may not achieve sufficient product revenues and our business will suffer.
The
market for our product candidates is characterized by intense competition and
rapid technological advances. If a product candidate receives FDA approval,
it
will compete with a number of existing and future drugs and therapies developed,
manufactured and marketed by others. Existing or future competing products
may
provide greater therapeutic convenience or clinical or other benefits for a
specific indication than our products, or may offer comparable performance
at a
lower cost. If our products fail to capture and maintain market share, we may
not achieve sufficient product revenues and our business will
suffer.
We
will
compete against fully integrated pharmaceutical companies and smaller companies
that are collaborating with larger pharmaceutical companies, academic
institutions, government agencies and other public and private research
organizations. Many of these competitors have products already approved or
in
development. In addition, many of these competitors, either alone or together
with their collaborative partners, operate larger research and development
programs or have substantially greater financial resources than we do, as well
as significantly greater experience in:
·
|
Developing
drugs;
|
·
|
Undertaking
preclinical testing and human clinical trials;
|
·
|
Obtaining
FDA and other regulatory approvals of drugs;
|
·
|
Formulating
and manufacturing drugs; and
|
·
|
Launching,
marketing and selling drugs.
|
If
we fail to adequately protect or enforce our intellectual property rights or
secure rights to patents of others, the value of our intellectual property
rights would diminish.
Our
success, competitive position and future revenues will depend in part on our
ability and the abilities of our licensors to obtain and maintain patent
protection for our products, methods, processes and other technologies, to
preserve our trade secrets, to prevent third parties from infringing on our
proprietary rights and to operate without infringing the proprietary rights
of
third parties.
To
date,
we have exclusive rights to certain U.S. and foreign intellectual property.
We
anticipate filing additional patent applications both in the U.S. and in other
countries, as appropriate. However, we cannot predict:
·
|
The
degree and range of protection any patents will afford us against
competitors, including
whether
third parties will find ways to invalidate or otherwise circumvent
our
patents;
|
·
|
If
and when patents will issue;
|
·
|
Whether
or not others will obtain patents claiming aspects similar to those
covered by our patents and patent applications; or
|
·
|
Whether
we will need to initiate litigation or administrative proceedings
which
may be costly whether we win or lose.
|
Our
success also depends upon the skills, knowledge and experience of our scientific
and technical personnel, our consultants and advisors as well as our licensors
and contractors. To help protect our proprietary know-how and our inventions
for
which patents may be unobtainable or difficult to obtain, we rely on trade
secret protection and confidentiality agreements. To this end, it is our policy
generally to require our employees, consultants, advisors and contractors to
enter into agreements which prohibit the disclosure of confidential information
and, where applicable, require disclosure and assignment to us of the ideas,
developments, discoveries and inventions important to our business. These
agreements may not provide adequate protection for our trade secrets, know-how
or other proprietary information in the event of any unauthorized use or
disclosure or the lawful development by others of such information. If any
of
our trade secrets, know-how or other proprietary information is disclosed,
the
value of our trade secrets, know-how and other proprietary rights would be
significantly impaired and our business and competitive position would
suffer.
If
we infringe the rights of third parties we could be prevented from selling
products, forced to pay damages, and defend against
litigation.
If
our
products, methods, processes or other technologies infringe the proprietary
rights of other parties, we could incur substantial costs and we may have
to:
·
|
Obtain
licenses, which may not be available on commercially reasonable terms,
if
at all;
|
·
|
Abandon
an infringing drug candidate;
|
·
|
Redesign
our products or processes to avoid infringement;
|
·
|
Stop
using the subject matter claimed in the patents held by others;
|
·
|
Pay
damages; or
|
·
|
Defend
litigation or administrative proceedings which may be costly whether
we
win or lose, and which could result in a substantial diversion of
our
valuable management resources.
|
Our
ability to generate product revenues will be diminished if our drugs sell for
inadequate prices or patients are unable to obtain adequate levels of
reimbursement.
Our
ability to commercialize our drugs, alone or with collaborators, will depend
in
part on the extent to which reimbursement will be available from:
·
|
Government
and health administration authorities;
|
·
|
Private
health maintenance organizations and health insurers; and
|
·
|
Other
healthcare payers.
|
Significant
uncertainty exists as to the reimbursement status of newly approved healthcare
products. Healthcare payers, including Medicare, are challenging the prices
charged for medical products and services. Government and other healthcare
payers increasingly attempt to contain healthcare costs by limiting both
coverage and the level of reimbursement for drugs. Even if our product
candidates are approved by the FDA, insurance coverage may not be available,
and
reimbursement levels may be inadequate, to cover our drugs. If government and
other healthcare payers do not provide adequate coverage and reimbursement
levels for our products, once approved, market acceptance of such products
could
be reduced.
We
may not be able to successfully manage our growth.
Our
success will depend upon the expansion of our operations and the effective
management of our growth, which will place a significant strain on our
management and on our administrative, operational and financial resources.
To
manage this growth, we must expand our facilities, augment our operational,
financial and management systems and hire and train additional qualified
personnel. If we are unable to manage our growth effectively, our business
may
be harmed.
Our
business will subject us to the risk of liability claims associated with the
use
of hazardous materials and chemicals.
Our
contract research and development activities may involve the controlled use
of
hazardous materials and chemicals. Although we believe that our safety
procedures for using, storing, handling and disposing of these materials comply
with federal, state and local laws and regulations, we cannot completely
eliminate the risk of accidental injury or contamination from these materials.
In the event of such an accident, we could be held liable for any resulting
damages and any liability could have a materially adverse effect on our
business, financial condition and results of operations. In addition, the
federal, state and local laws and regulations governing the use, manufacture,
storage, handling and disposal of hazardous or radioactive materials and waste
products may require our contractors to incur substantial compliance costs
that
could materially adversely affect our business, financial condition and results
of operations.
We
rely on key executive officers and scientific and medical advisors, and their
knowledge of our business and technical expertise would be difficult to replace.
We
are
highly dependent on our principal scientific, regulatory and medical advisors.
We do not have “key person” life insurance policies on any of our officers. The
loss of the technical knowledge and management and industry expertise of any
of
our key personnel could result in delays in product development, loss of
customers and sales and diversion of management resources, which could adversely
affect our operating results.
If
we are unable to hire additional qualified personnel, our ability to grow our
business may be harmed.
We
will
need to hire additional qualified personnel with expertise in preclinical
testing, clinical research and testing, government regulation, formulation
and
manufacturing, as well as sales and marketing. We compete for qualified
individuals with numerous biopharmaceutical companies, universities and other
research institutions. Competition for such individuals is intense, and we
cannot be certain that our search for such personnel will be successful.
Attracting and retaining qualified personnel will be critical to our
success.
We
may incur substantial liabilities and may be required to limit commercialization
of our products in response to product liability lawsuits.
The
testing and marketing of medical products entail an inherent risk of product
liability. If we cannot successfully defend ourselves against product liability
claims, we may incur substantial liabilities or be required to limit
commercialization of our products. Our inability to obtain sufficient product
liability insurance at an acceptable cost to protect against potential product
liability claims could prevent or inhibit the commercialization of
pharmaceutical products we develop, alone or with collaborators. We currently
carry clinical trial insurance and product liability insurance.
There
are certain interlocking relationships among us and certain affiliates of a
significant stockholder of ours, which may present potential conflicts of
interest.
Lindsay
A. Rosenwald, M.D., who may be deemed to beneficially own approximately 9.9%
of
our common stock as of June 26, 2006, is Chairman and Chief Executive
Officer of Paramount BioCapital, Inc., an investment banking firm that served
as
a co-placement agent in connection with our May 2006 financing. Paramount
BioCapital also served as placement agent in connection with a private placement
of ZIOPHARM, Inc.’s Series A Convertible Preferred Stock that was completed in
May 2005 and served as a finder in connection with our option and research
agreements with Southern Research Institute. We paid fees and issued securities
to Paramount BioCapital or its designees in connection with these transactions
and Paramount BioCapital currently has a right of first refusal to act as the
placement agent for the private sale of our securities until May 31, 2008.
Dr.
Michael Weiser and Timothy McInerney, each of whom is a member of our board
of
directors, are also full-time employees of Paramount BioCapital.
Paramount
BioCapital, Dr. Rosenwald, Dr. Weiser, and Mr. McInerney are not obligated
pursuant to any agreement or understanding with us to make any additional
products or technologies available to us, nor can there be any assurance that
any biomedical or pharmaceutical products or technologies identified in the
future by such parties will be made available to us. In addition, certain of
our
current officers and directors, as well as officers or directors that may be
hereafter appointed, may from time to time serve as officers or directors of
other biopharmaceutical or biotechnology companies. There can be no assurance
that such other companies will not have interests in conflict with our own.
Because
we became public by means of a reverse merger, we may not be able to attract
the
attention of major brokerage firms.
Additional
risks may exist as a result of our becoming a public reporting company through
a
“reverse merger.” Security analysts of major brokerage firms may not provide
coverage of the Company. Because we became public through a reverse merger,
there is no incentive to brokerage firms to recommend the purchase of our common
stock. No assurance can be given that brokerage firms will want to provide
analyst coverage of our Company in the future.
We
are subject to Sarbanes-Oxley and the reporting requirements of federal
securities laws, which can be expensive.
As
a
public reporting company, we are subject to the Sarbanes-Oxley Act of 2002,
as
well as the information and reporting requirements of the Securities Exchange
Act of 1934, as amended, and other federal securities laws. As a result, we
incur significant legal, accounting and other expenses that we did not incur
as
a private company, including costs associated with our public company reporting
requirements and corporate governance requirements. As an example of public
reporting company requirements, we evaluate the effectiveness of disclosure
controls and procedures and of our internal control over financing reporting
in
order to allow management to report on such controls.
As
a
company with limited capital and human resources, our management has identified
that there is a lack of segregation of duties due to the limited number of
employees within our company’s financial and administrative functions.
Management believes that, based on the employees involved and the control
procedures in place, risks associated with such lack of segregation are not
significant and that the potential benefits of adding employees to segregate
duties more clearly do not justify the associated added expense. However,
management continues to evaluate this lack of segregation of duties.
Furthermore, management is aware that many of our currently existing internal
controls are undocumented. Our management will be working to document such
internal controls over the coming year. In the event we identify significant
deficiencies or material weaknesses in our internal control over financial
reporting that we cannot remediate in a timely manner, investors and others
may
lose confidence in the reliability of our financial statements and the trading
price of our common stock and ability to obtain any necessary equity or debt
financing could suffer.
Our
common stock trades only in an illiquid trading market.
Trading
of our common stock is conducted on the Over-The-Counter Bulletin Board
(“OTCBB”). This has an adverse effect on the liquidity of our common stock, not
only in terms of the number of shares that can be bought and sold at a given
price, but also through delays in the timing of transactions and reduction
in
security analysts’ and the media’s coverage of our Company and its common stock.
This may result in lower prices for our common stock than might otherwise be
obtained and could also result in a larger spread between the bid and asked
prices for our common stock.
There
is not now, and there may not ever be an active market for shares of our common
stock.
In
general, there has been limited trading activity in shares of the Company’s
common stock. The small trading volume may make it more difficult for our
stockholders to sell their shares as and when they choose. Furthermore, small
trading volumes generally depress market prices. As a result, you may not always
be able to resell shares of our common stock publicly at the time and prices
that you feel are fair or appropriate.
Because
it is a “penny stock,” you may have difficulty selling shares of our common
stock.
Our
common stock is a “penny stock” and is therefore subject to the requirements of
Rule 15g-9 under the Securities and Exchange Act of 1934. Under this rule,
broker-dealers who sell penny stocks must provide purchasers of these stocks
with a standardized risk-disclosure document prepared by the Securities and
Exchange Commission. Under applicable regulations, our common stock will
generally remain a “penny stock” until and for such time as it meets certain per
share price requirements (as determined in accordance with SEC regulations),
or
until we meet certain net asset or revenue thresholds.
The
penny
stock rules severely limit the liquidity of securities in the secondary market,
and many brokers choose not to participate in penny stock transactions. As
a
result, there is generally less trading in penny stocks. If you become a holder
of our common stock, you may not always be able to resell shares of our common
stock publicly at the time and prices that you feel are fair or
appropriate.
We
have never paid dividends and do not intend to do so for the foreseeable future.
We
have
never paid dividends on our capital stock and we do not anticipate that we
will
pay any dividends for the foreseeable future. Accordingly, any return on an
investment in our Company will be realized, if at all, only when you sell shares
of our common stock.
NOTE
REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus, including the documents that we incorporate by reference, contains
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, or the Securities Act, and Section 21E
of the Exchange Act. Any statements about our expectations, beliefs, plans,
objectives, assumptions or future events or performance are not historical
facts
and may be forward-looking. These statements are often, but not always, made
through the use of words or phrases such as anticipate, estimate, plan, project,
continuing, ongoing, expect, management believes, we believe, we intend and
similar words or phrases. Accordingly, these statements involve estimates,
assumptions and uncertainties that could cause actual results to differ
materially from those expressed in them. Any forward-looking statements are
qualified in their entirety by reference to the factors discussed in this
prospectus or incorporated by reference.
Because
the factors discussed in this prospectus or incorporated by reference could
cause actual results or outcomes to differ materially from those expressed
in
any forward-looking statements made by us or on our behalf, you should not
place
undue reliance on any such forward-looking statements. These statements are
subject to risks and uncertainties, known and unknown, which could cause actual
results and developments to differ materially from those expressed or implied
in
such statements. Such risks and uncertainties relate to, among other factors:
the development of our drug candidates; the regulatory approval of our drug
candidates; our use of clinical research centers and other contractors; our
ability to find collaborative partners for research, development and
commercialization of potential products; acceptance of our products by doctors,
patients or payors; our ability to market any of our products; our history
of
operating losses; our ability to compete against other companies and research
institutions; our ability to secure adequate protection for our intellectual
property; our ability to attract and retain key personnel; availability of
reimbursement for our product candidates; the effect of potential strategic
transactions on our business; our ability to obtain adequate financing; and
the
volatility of our stock price. These and other risks are detailed in this
prospectus under the discussion entitled “Risk Factors,” as well as in our
reports filed from time to time under the Securities Act and/or the Exchange
Act. You are encouraged 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
will
not receive any proceeds from the resale of any of the shares offered by this
prospectus by the selling stockholders.
SELLING
STOCKHOLDERS
This
prospectus covers the resale by the selling stockholders identified below
of
7,140,702 shares of our common stock, including shares issuable upon the
exercise of warrants. This offering includes 6,517,124 shares of our common
stock issued to the former stockholders of ZIOPHARM, Inc. in connection
with our September 2005 merger with that company, 482,407 shares of
our common stock issuable upon the exercise of warrants held by such former
ZIOPHARM, Inc. stockholders at the time of the merger, 83,348 shares of our
common stock issued to a previous EasyWeb Inc. stockholder upon the exercise
of
a stock option, and 57,723 shares of EasyWeb, Inc. which were outstanding
prior to the merger.
The
following table sets forth the number of shares of the common stock owned
by the
selling stockholders as of June 14, 2006, and after giving effect to this
offering.
Selling
Stockholder
|
|
Shares
Beneficially Owned Before Offering (1)
|
|
Number
of Outstanding Shares Offered by Selling
Stockholder
|
|
Number
of Shares Offered by Selling Stockholder upon Exercise of Certain
Warrants
|
|
Percentage
Beneficial Ownersip After Offering (2)
|
|
335
MAD LLC (f/k/a/ Beck Technologies LLC)
|
|
|
3,757
|
|
|
3,757
|
|
|
0
|
|
|
--
|
|
Aaron
Rollins
|
|
|
3,036
|
|
|
3,036
|
|
|
0
|
|
|
-
|
|
Aaron
Speisman
|
|
|
1,566
|
|
|
1,566
|
|
|
0
|
|
|
--
|
|
Al
Hoff
|
|
|
100
|
|
|
100
|
|
|
0
|
|
|
--
|
|
Alan
Clingman
|
|
|
1,252
|
|
|
1,252
|
|
|
0
|
|
|
--
|
|
Alan
H. Auerbach
|
|
|
5,798
|
|
|
5,798
|
|
|
0
|
|
|
--
|
|
Alan
J. Young
|
|
|
4,000
|
|
|
4,000
|
|
|
0
|
|
|
--
|
|
Albert
J. Zirkelbach
|
|
|
50
|
|
|
50
|
|
|
0
|
|
|
--
|
|
Alfred
Abraham
|
|
|
4,639
|
|
|
4,639
|
|
|
0
|
|
|
--
|
|
Allen
R Goldstone
|
|
|
25
|
|
|
25
|
|
|
0
|
|
|
--
|
|
Allison
Robbins
|
|
|
1,518
|
|
|
1,518
|
|
|
0
|
|
|
-
|
|
Anderson
J Henshaw C. Eugene Gronning
|
|
|
100
|
|
|
100
|
|
|
0
|
|
|
--
|
|
Andrew
H. Sabreen and Carol Sabreen JTWROS
|
|
|
11,596
|
|
|
11,596
|
|
|
0
|
|
|
--
|
|
Andrew
W. Albstein and Carolyn Albstein JTWROS
|
|
|
37,232
|
|
|
23,193
|
|
|
0
|
|
|
*
|
|
Andrew
W. Schonzeit
|
|
|
13,472
|
|
|
5,049
|
|
|
0
|
|
|
*
|
|
Anil
Chenthitta
|
|
|
3,036
|
|
|
3,036
|
|
|
0
|
|
|
-
|
|
Anthony
G. Polak “S”
|
|
|
5,798
|
|
|
5,798
|
|
|
0
|
|
|
--
|
|
Anthony
J. Gerace
|
|
|
11,597
|
|
|
11,597
|
|
|
0
|
|
|
--
|
|
Anthony
J. Ottavio
|
|
|
20,947
|
|
|
12,524
|
|
|
0
|
|
|
*
|
|
Associate
Capital Consulting Inc.
|
|
|
50
|
|
|
50
|
|
|
0
|
|
|
--
|
|
Atlas
Equity I, Ltd.
|
|
|
695,796
|
|
|
695,796
|
|
|
0
|
|
|
--
|
|
B
Kathleen Goldstone
|
|
|
25
|
|
|
25
|
|
|
0
|
|
|
--
|
|
Balanced
Investment, LLC
|
|
|
46,386
|
|
|
46,386
|
|
|
0
|
|
|
--
|
|
Barbara
Petrinsky
|
|
|
442
|
|
|
442
|
|
|
0
|
|
|
--
|
|
Barry
Lind Revocable Trust
|
|
|
38,386
|
|
|
38,386
|
|
|
0
|
|
|
--
|
|
Barry
P. McIntosh
|
|
|
5,798
|
|
|
5,798
|
|
|
0
|
|
|
--
|
|
Baruch
Z. Halberstam
|
|
|
5,798
|
|
|
5,798
|
|
|
0
|
|
|
--
|
|
Basil
Christakos
|
|
|
8,678
|
|
|
6,072
|
|
|
0
|
|
|
*
|
|
Benito
Bucay
|
|
|
11,596
|
|
|
11,596
|
|
|
0
|
|
|
--
|
|
Benjamin
Feinswog Trust
|
|
|
3,757
|
|
|
3,757
|
|
|
0
|
|
|
--
|
|
Bernard
Gross
|
|
|
10,285
|
|
|
1,518
|
|
|
8,767
|
|
|
--
|
|
Bernard
Wachsman
|
|
|
5,798
|
|
|
5,798
|
|
|
0
|
|
|
--
|
|
Black
Marlen Inc
|
|
|
100
|
|
|
100
|
|
|
0
|
|
|
--
|
|
Brad
Henshaw C. Eugene Gronning
|
|
|
100
|
|
|
100
|
|
|
0
|
|
|
--
|
|
Brad
Rhodes
|
|
|
200
|
|
|
200
|
|
|
0
|
|
|
--
|
|
Brent
Henshaw
|
|
|
7,959
|
|
|
7,959
|
|
|
0
|
|
|
--
|
|
Brino
Investment Ltd.
|
|
|
5,798
|
|
|
5,798
|
|
|
0
|
|
|
--
|
|
Bryant
Kligerman
|
|
|
100
|
|
|
100
|
|
|
0
|
|
|
--
|
|
Carl
S. Sorenson
|
|
|
11,597
|
|
|
11,597
|
|
|
0
|
|
|
--
|
|
Carlene
Smith
|
|
|
25
|
|
|
25
|
|
|
0
|
|
|
--
|
|
Carolyn
N. Taylor
|
|
|
3,506
|
|
|
3,506
|
|
|
0
|
|
|
--
|
|
Carolyn
P. Dietrich
|
|
|
6,006
|
|
|
6,006
|
|
|
0
|
|
|
--
|
|
Carucci
Family Partners
|
|
|
73,828
|
|
|
34,789
|
|
|
0
|
|
|
*
|
|
Charles
Earl Cartmill
|
|
|
11,596
|
|
|
11,596
|
|
|
0
|
|
|
--
|
|
Charles
Schwab & Co. Inc.
|
|
|
50
|
|
|
50
|
|
|
0
|
|
|
--
|
|
Chase
Financing, Inc.
|
|
|
83,348
|
|
|
83,348
|
|
|
0
|
|
|
-
|
|
Claudia
Donat
|
|
|
3,036
|
|
|
3,036
|
|
|
0
|
|
|
-
|
|
Concordia
Partners L.P.
|
|
|
175,341
|
|
|
175,341
|
|
|
0
|
|
|
--
|
|
Cooper
A. McIntosh, MD
|
|
|
22,827
|
|
|
11,596
|
|
|
0
|
|
|
*
|
|
Coqui
Capital Partners
|
|
|
57,983
|
|
|
57,983
|
|
|
0
|
|
|
--
|
|
Craig
M Blake
|
|
|
50
|
|
|
50
|
|
|
0
|
|
|
--
|
|
Curtis
M McQueen
|
|
|
50
|
|
|
50
|
|
|
0
|
|
|
--
|
|
Daniel
J. Kevles and Betty Ann Kevles JTWROS
|
|
|
8,117
|
|
|
8,117
|
|
|
0
|
|
|
--
|
|
Daniel
Krieger
|
|
|
5,798
|
|
|
5,798
|
|
|
0
|
|
|
--
|
|
Danielle
Flatly
|
|
|
1,518
|
|
|
1,518
|
|
|
0
|
|
|
-
|
|
Darrell
J Brunken
|
|
|
25
|
|
|
25
|
|
|
0
|
|
|
--
|
|
David
Butera
|
|
|
60,723
|
|
|
60,723
|
|
|
0
|
|
|
-
|
|
David
C. Olson
|
|
|
4,586
|
|
|
4,586
|
|
|
0
|
|
|
--
|
|
David
G. Pudelsky and Nancy H. Pudelsky JTWROS
|
|
|
10,019
|
|
|
10,019
|
|
|
0
|
|
|
--
|
|
David
J. Bershad
|
|
|
3,131
|
|
|
3,131
|
|
|
0
|
|
|
--
|
|
David
Nussbaum
|
|
|
3,036
|
|
|
3,036
|
|
|
0
|
|
|
-
|
|
David
P. Luci
|
|
|
2,319
|
|
|
2,319
|
|
|
0
|
|
|
--
|
|
David
Tanen
|
|
|
12,144
|
|
|
12,144
|
|
|
0
|
|
|
-
|
|
Dean
Glasser
|
|
|
3,757
|
|
|
3,757
|
|
|
0
|
|
|
--
|
|
Delaware
Charter Guarantee & Trust Co. FBO Howard M. Tanning MD IRA
|
|
|
25,048
|
|
|
25,048
|
|
|
0
|
|
|
--
|
|
Delaware
Charter Guarantee Trust FBO Mark Berg IRA
|
|
|
57,612
|
|
|
57,612
|
|
|
0
|
|
|
--
|
|
Delaware
Charter Guarantee Trust FBO Richard S. Simms II Keogh Plan
|
|
|
3,478
|
|
|
3,478
|
|
|
0
|
|
|
--
|
|
Delores
Ferraro
|
|
|
1,518
|
|
|
1,518
|
|
|
0
|
|
|
-
|
|
Demitrios
Marras
|
|
|
1,518
|
|
|
1,518
|
|
|
0
|
|
|
-
|
|
Denise
Mormile-Liglino
|
|
|
1,252
|
|
|
0
|
|
|
1,252
|
|
|
--
|
|
Dennis
F. Steadman
|
|
|
5,798
|
|
|
5,798
|
|
|
0
|
|
|
--
|
|
Derek
J. Zappa
|
|
|
100
|
|
|
100
|
|
|
0
|
|
|
--
|
|
Domaco
Venture Capital Fund
|
|
|
5,798
|
|
|
5,798
|
|
|
0
|
|
|
--
|
|
Don
F. Sims
|
|
|
50
|
|
|
50
|
|
|
0
|
|
|
--
|
|
Donna
Kash & Peter Kash JT TEN
|
|
|
5,010
|
|
|
5,010
|
|
|
0
|
|
|
--
|
|
Donna
Lozito
|
|
|
6,072
|
|
|
6,072
|
|
|
0
|
|
|
-
|
|
Douglas
A Wilkerson & Leola A Wilkerson JTTEN
|
|
|
25
|
|
|
25
|
|
|
0
|
|
|
--
|
|
Doyle
S Elliott
|
|
|
25
|
|
|
25
|
|
|
0
|
|
|
--
|
|
Edmund
A. Debler
|
|
|
17,033
|
|
|
17,033
|
|
|
0
|
|
|
--
|
|
Edward
W Bellarose
|
|
|
100
|
|
|
100
|
|
|
0
|
|
|
--
|
|
Edwin
A. Buckham and Wendy F. Buckham, JTWROS
|
|
|
11,596
|
|
|
11,596
|
|
|
0
|
|
|
--
|
|
Elbert
Chu
|
|
|
1,822
|
|
|
1,822
|
|
|
0
|
|
|
-
|
|
Elena
Ridloff
|
|
|
5,465
|
|
|
5,465
|
|
|
0
|
|
|
-
|
|
Eli
Jaconson
|
|
|
23,194
|
|
|
23,194
|
|
|
0
|
|
|
--
|
|
Elizabeth
Maas
|
|
|
5,798
|
|
|
5,798
|
|
|
0
|
|
|
--
|
|
Elizabeth
Marrero
|
|
|
1,518
|
|
|
1,518
|
|
|
0
|
|
|
-
|
|
Elizabeth
R. Moore
|
|
|
5,798
|
|
|
5,798
|
|
|
0
|
|
|
--
|
|
Ennio
DePianto
|
|
|
6,011
|
|
|
6,011
|
|
|
0
|
|
|
--
|
|
Eric
Lee
|
|
|
3,036
|
|
|
3,036
|
|
|
0
|
|
|
-
|
|
Eric
Reed
|
|
|
5,009
|
|
|
5,009
|
|
|
0
|
|
|
--
|
|
Everest
Capital (f/k/a Four Brothers Investment Holding)
|
|
|
12,524
|
|
|
12,524
|
|
|
0
|
|
|
--
|
|
Fabio
Migliaccio
|
|
|
2,504
|
|
|
0
|
|
|
2,504
|
|
|
--
|
|
Fae
Moore
|
|
|
5,798
|
|
|
5,798
|
|
|
0
|
|
|
--
|
|
Far
Ventures
|
|
|
10,019
|
|
|
10,019
|
|
|
0
|
|
|
--
|
|
Fiserv
Securities, Inc. A/C/F Anthony G. Polak Std. IRA
|
|
|
5,798
|
|
|
5,798
|
|
|
0
|
|
|
--
|
|
Fiserv
Securities, Inc. A/C/F Jack Polar IRA
|
|
|
5,798
|
|
|
5,798
|
|
|
0
|
|
|
--
|
|
Fiserv
Securities, Inc. A/C/F Ronald M. Lazar, STD IRA
|
|
|
5,798
|
|
|
5,798
|
|
|
0
|
|
|
--
|
|
Frank
Calcutta
|
|
|
12,524
|
|
|
12,524
|
|
|
0
|
|
|
--
|
|
Future
Global Holding, Inc.
|
|
|
626
|
|
|
626
|
|
|
0
|
|
|
--
|
|
Gabriel
Pilaloa
|
|
|
1,518
|
|
|
1,518
|
|
|
0
|
|
|
--
|
|
Gary
J. Strauss
|
|
|
23,193
|
|
|
23,194
|
|
|
0
|
|
|
--
|
|
Gary
Mendenhall
|
|
|
25
|
|
|
25
|
|
|
0
|
|
|
--
|
|
Gavin
Kent
|
|
|
5,798
|
|
|
5,798
|
|
|
0
|
|
|
--
|
|
Gitel
Family Partnership, LP
|
|
|
23,193
|
|
|
23,193
|
|
|
0
|
|
|
--
|
|
Gregory
J. Dovolis
|
|
|
10,019
|
|
|
10,019
|
|
|
0
|
|
|
--
|
|
Harris
Lydon
|
|
|
58,931
|
|
|
0
|
|
|
22,349
|
|
|
*
|
|
Harry
Newton and Susan Newton JTWROS
|
|
|
38,591
|
|
|
17,534
|
|
|
0
|
|
|
*
|
|
Harvey
Levin
|
|
|
25
|
|
|
25
|
|
|
0
|
|
|
--
|
|
Harvey
Lustig and Ronnie Lustig JTWROS
|
|
|
5,009
|
|
|
5,009
|
|
|
0
|
|
|
--
|
|
Henry
and Monica Millin
|
|
|
1,252
|
|
|
1,252
|
|
|
0
|
|
|
--
|
|
Hill
Blalock, Jr.
|
|
|
23,195
|
|
|
23,195
|
|
|
0
|
|
|
--
|
|
Howard
Sorkin
|
|
|
23,193
|
|
|
23,193
|
|
|
0
|
|
|
--
|
|
Isaac
R. Dweck
|
|
|
23,193
|
|
|
23,193
|
|
|
0
|
|
|
--
|
|
Issac
M. Dabah
|
|
|
10,019
|
|
|
10,019
|
|
|
0
|
|
|
--
|
|
Ivy
Scheinholz Revocable Trust U/A Dated 1/26/05
|
|
|
5,009
|
|
|
5,009
|
|
|
0
|
|
|
--
|
|
Jack
B. Petersen
|
|
|
5,798
|
|
|
5,798
|
|
|
0
|
|
|
--
|
|
James
C. Shepler and Diana B. Shepler JTWROS
|
|
|
6,957
|
|
|
6,957
|
|
|
0
|
|
|
--
|
|
James
H Swalwell & Judith A Swalwell JTTEN
|
|
|
50
|
|
|
50
|
|
|
0
|
|
|
--
|
|
James
J Trainor
|
|
|
125
|
|
|
125
|
|
|
0
|
|
|
--
|
|
Jamie
Cabibihan
|
|
|
1,768
|
|
|
1,768
|
|
|
0
|
|
|
-
|
|
Janis
H. Camp
|
|
|
5,798
|
|
|
5,798
|
|
|
0
|
|
|
--
|
|
Jason
Stein
|
|
|
83,445
|
|
|
83,445
|
|
|
0
|
|
|
-
|
|
Jay
Lobell
|
|
|
94,252
|
|
|
59,156
|
|
|
0
|
|
|
*
|
|
Jeana
Sommers
|
|
|
1,808
|
|
|
1,518
|
|
|
290
|
|
|
--
|
|
Jeff
Rodriguez
|
|
|
25
|
|
|
25
|
|
|
0
|
|
|
--
|
|
Jeffrey
Kraws & Patricia Kraws
|
|
|
5,798
|
|
|
5,798
|
|
|
0
|
|
|
--
|
|
Jeffrey
Myers
|
|
|
1,692
|
|
|
1,692
|
|
|
0
|
|
|
--
|
|
Jeffrey
Serbin
|
|
|
91,035
|
|
|
91,035
|
|
|
0
|
|
|
-
|
|
Jennifer
McNealy
|
|
|
5,465
|
|
|
5,465
|
|
|
0
|
|
|
-
|
|
Jerrold
Abrahams
|
|
|
6,957
|
|
|
6,957
|
|
|
0
|
|
|
--
|
|
Jill
Meleski
|
|
|
19,674
|
|
|
3,036
|
|
|
16,638
|
|
|
--
|
|
Jillian
Hoffman
|
|
|
7,590
|
|
|
7,590
|
|
|
0
|
|
|
-
|
|
Joe
L. Key and Mary Lynn Key JTWROS
|
|
|
1,001
|
|
|
1,001
|
|
|
0
|
|
|
--
|
|
Joel
Braun
|
|
|
5,798
|
|
|
5,798
|
|
|
0
|
|
|
--
|
|
Johanna
Guttman & Robert Herskowitz JTEN
|
|
|
10,750
|
|
|
10,750
|
|
|
0
|
|
|
--
|
|
John
and Debbra Landsberger Family Trust
|
|
|
12,524
|
|
|
12,524
|
|
|
0
|
|
|
--
|
|
John
Best
|
|
|
1,822
|
|
|
1,822
|
|
|
0
|
|
|
-
|
|
John
Cipriano
|
|
|
5,465
|
|
|
5,465
|
|
|
0
|
|
|
-
|
|
John
Cleaver & Karen Cleaver JTTEN
|
|
|
100
|
|
|
100
|
|
|
0
|
|
|
--
|
|
John
Knox
|
|
|
19,470
|
|
|
9,108
|
|
|
0
|
|
|
*
|
|
John
O. Dunkin
|
|
|
6,011
|
|
|
6,012
|
|
|
0
|
|
|
--
|
|
John
Papadimitropoulos
|
|
|
3,036
|
|
|
3,036
|
|
|
0
|
|
|
-
|
|
Joseph
Friedman Trust
|
|
|
1,252
|
|
|
1,252
|
|
|
0
|
|
|
--
|
|
Joseph
J. Vale
|
|
|
115,965
|
|
|
115,966
|
|
|
0
|
|
|
--
|
|
Joseph
Sorbara
|
|
|
6,480
|
|
|
0
|
|
|
6,480
|
|
|
--
|
|
Joseph
Strassman and Barbara Strassman
|
|
|
6,957
|
|
|
6,957
|
|
|
0
|
|
|
--
|
|
Joshua
Kazam and Joia Kazam JTWROS
|
|
|
12,145
|
|
|
12,145
|
|
|
0
|
|
|
-
|
|
Judah
Schorr
|
|
|
34,790
|
|
|
34,790
|
|
|
0
|
|
|
--
|
|
Kanter
Family Foundation
|
|
|
1,878
|
|
|
1,878
|
|
|
0
|
|
|
--
|
|
Karl
Ruggeberg
|
|
|
9,368
|
|
|
1,518
|
|
|
7,850
|
|
|
|
|
Kathleen
Fogerty
|
|
|
1,518
|
|
|
1,518
|
|
|
0
|
|
|
-
|
|
Keith
Rubenstein
|
|
|
5,798
|
|
|
5,798
|
|
|
0
|
|
|
--
|
|
Kinder
Investments L.P.
|
|
|
34,789
|
|
|
34,789
|
|
|
0
|
|
|
--
|
|
Klaus
Kretschmer
|
|
|
74,667
|
|
|
46,590
|
|
|
0
|
|
|
*
|
|
Kristen
Plonisch
|
|
|
1,518
|
|
|
1,518
|
|
|
0
|
|
|
-
|
|
Kyle
Kuhn
|
|
|
6,072
|
|
|
6,072
|
|
|
0
|
|
|
-
|
|
Lamar
F Schild
|
|
|
500
|
|
|
500
|
|
|
0
|
|
|
--
|
|
Lawrence
Alpert
|
|
|
500
|
|
|
500
|
|
|
0
|
|
|
--
|
|
Laya
Perlysky 2003 Grantor Retained Annuity Trust
|
|
|
23,193
|
|
|
23,193
|
|
|
0
|
|
|
--
|
|
Lillian
Hahn
|
|
|
3,131
|
|
|
3,131
|
|
|
0
|
|
|
--
|
|
Lind
Family Investments LP
|
|
|
5,117
|
|
|
5,117
|
|
|
0
|
|
|
--
|
|
Lindsay
A. Rosenwald
|
|
|
1,573,794
|
|
|
476,678
|
|
|
221,011
|
|
|
5.46
|
%
|
Louis
R. Reif
|
|
|
22,543
|
|
|
22,543
|
|
|
0
|
|
|
--
|
|
Louis
Sanzo, Jr.
|
|
|
5,010
|
|
|
5,010
|
|
|
0
|
|
|
--
|
|
Louis
Smookler
|
|
|
17,326
|
|
|
12,145
|
|
|
0
|
|
|
*
|
|
Lucile
Slocum
|
|
|
10,019
|
|
|
10,019
|
|
|
0
|
|
|
--
|
|
Lyn
C Wilkerson
|
|
|
30
|
|
|
30
|
|
|
0
|
|
|
--
|
|
Mario
Pasquel and Begona Miranda JTWROS
|
|
|
23,254
|
|
|
16,235
|
|
|
0
|
|
|
*
|
|
Marion
Birch
|
|
|
1,518
|
|
|
1,518
|
|
|
0
|
|
|
-
|
|
Mark
J. Ahn
|
|
|
5,798
|
|
|
5,798
|
|
|
0
|
|
|
--
|
|
Mark
Mazzer
|
|
|
6,262
|
|
|
6,262
|
|
|
0
|
|
|
--
|
|
Mark
O. Thornton
|
|
|
8,370
|
|
|
8,370
|
|
|
0
|
|
|
-
|
|
Matador
Investments Pte Ltd.
|
|
|
16,235
|
|
|
16,235
|
|
|
0
|
|
|
--
|
|
Mathew
Meister c/o Beeman Holdings
|
|
|
25
|
|
|
25
|
|
|
0
|
|
|
--
|
|
Mega
International Corporation
|
|
|
8,581
|
|
|
8,581
|
|
|
0
|
|
|
--
|
|
Mibars,
LLC
|
|
|
1,214,456
|
|
|
1,214,456
|
|
|
0
|
|
|
-
|
|
Michael
Blechman and Barry J. Lind, Tenants in Common
|
|
|
9,596
|
|
|
9,596
|
|
|
0
|
|
|
--
|
|
Michael
Gundzik C. Eugene Gronning
|
|
|
100
|
|
|
100
|
|
|
0
|
|
|
--
|
|
Michael
J Stallone
|
|
|
200
|
|
|
200
|
|
|
0
|
|
|
--
|
|
Michael
Luftman
|
|
|
5,798
|
|
|
5,798
|
|
|
0
|
|
|
--
|
|
Michael
M Edmonds
|
|
|
100
|
|
|
100
|
|
|
0
|
|
|
--
|
|
Michael
Mullen
|
|
|
13,534
|
|
|
0
|
|
|
13,534
|
|
|
--
|
|
Michael
Rosenman
|
|
|
64,797
|
|
|
12,145
|
|
|
19,709
|
|
|
*
|
|
Michael
S. Walsh
|
|
|
5,798
|
|
|
5,798
|
|
|
0
|
|
|
--
|
|
Michael
Weiser
|
|
|
159,845
|
|
|
83,445
|
|
|
35,566
|
|
|
*
|
|
Michele
Markowitz
|
|
|
5,798
|
|
|
5,798
|
|
|
0
|
|
|
--
|
|
Millennium
Partners, L.P.
|
|
|
793,486
|
|
|
231,931
|
|
|
0
|
|
|
3.54
|
%
|
Morri
L Namaste
|
|
|
100
|
|
|
100
|
|
|
0
|
|
|
--
|
|
Murry
J. McCabe
|
|
|
104,541
|
|
|
34,789
|
|
|
0
|
|
|
*
|
|
National
Financial Services LLC
|
|
|
25
|
|
|
25
|
|
|
0
|
|
|
--
|
|
National
Investors Services Corp. FBO Stephen J. Nelson
|
|
|
23,193
|
|
|
23,193
|
|
|
0
|
|
|
--
|
|
Neel
B. Ackerman and Martha N. Ackerman JTWROS
|
|
|
25,048
|
|
|
25,048
|
|
|
0
|
|
|
--
|
|
Neil
Herskowitz
|
|
|
25,805
|
|
|
6,262
|
|
|
0
|
|
|
*
|
|
Neil
J. Laird
|
|
|
6,011
|
|
|
6,011
|
|
|
0
|
|
|
--
|
|
Nicholas
Ponzio
|
|
|
24,048
|
|
|
24,048
|
|
|
0
|
|
|
--
|
|
Nicole
Berg
|
|
|
169,923
|
|
|
57,612
|
|
|
0
|
|
|
*
|
|
Nicole
Netolicky
|
|
|
1,517
|
|
|
1,517
|
|
|
0
|
|
|
-
|
|
Nora
O’Donoghue
|
|
|
5,798
|
|
|
5,798
|
|
|
0
|
|
|
--
|
|
NTP
Partners
|
|
|
3,131
|
|
|
3,131
|
|
|
0
|
|
|
--
|
|
OZF
Investments LLC
|
|
|
115,965
|
|
|
115,965
|
|
|
0
|
|
|
--
|
|
Paramount
BioCapital, Inc.
|
|
|
62,621
|
|
|
0
|
|
|
62,621
|
|
|
--
|
|
Paul
Bermanski and Barbara Bermanski JTWROS
|
|
|
11,596
|
|
|
11,596
|
|
|
0
|
|
|
--
|
|
Paul
D. Newman and Judith E. Newman JTWROS
|
|
|
6,011
|
|
|
6,011
|
|
|
0
|
|
|
--
|
|
Paul
F. Berlin
|
|
|
5,798
|
|
|
5,798
|
|
|
0
|
|
|
--
|
|
Paul
J. Solit
|
|
|
14,221
|
|
|
5,798
|
|
|
0
|
|
|
*
|
|
Paul
Sallwasser and Teri Sallwasser JTWROS
|
|
|
17,394
|
|
|
17,394
|
|
|
0
|
|
|
--
|
|
Pearl
Capital LP (f/k/a Weisenberg Real Estate LP)
|
|
|
1,252
|
|
|
1,252
|
|
|
0
|
|
|
--
|
|
Peter
Barber
|
|
|
3,288
|
|
|
3,036
|
|
|
0
|
|
|
-
|
|
Peter
Kash
|
|
|
83,445
|
|
|
83,445
|
|
|
0
|
|
|
-
|
|
Phil
Lifshitz
|
|
|
4,095
|
|
|
4,095
|
|
|
0
|
|
|
--
|
|
Philip
J. Abdalla and Joyce V. Abdalla JTWROS
|
|
|
6,011
|
|
|
6,011
|
|
|
0
|
|
|
--
|
|
Praful
Desai
|
|
|
5,009
|
|
|
5,009
|
|
|
0
|
|
|
--
|
|
Rachel
Family Partnership
|
|
|
34,789
|
|
|
34,789
|
|
|
0
|
|
|
--
|
|
Ramsay
Investments Pte. Ltd.
|
|
|
2,319
|
|
|
2,319
|
|
|
0
|
|
|
--
|
|
Rick
J. Goad
|
|
|
10,019
|
|
|
10,019
|
|
|
0
|
|
|
--
|
|
Riverside
Contracting LLC
|
|
|
25,805
|
|
|
12,524
|
|
|
0
|
|
|
*
|
|
RL
Capital Partners, LP
|
|
|
11,597
|
|
|
11,597
|
|
|
0
|
|
|
--
|
|
Robert
D. Millstone
|
|
|
3,479
|
|
|
0
|
|
|
3,479
|
|
|
--
|
|
Robert
E Ohman
|
|
|
25
|
|
|
25
|
|
|
0
|
|
|
--
|
|
Robert
Falk
|
|
|
1,252
|
|
|
1,252
|
|
|
0
|
|
|
--
|
|
Robert
Guercio
|
|
|
7,514
|
|
|
7,514
|
|
|
0
|
|
|
--
|
|
Robert
Herskowitz
|
|
|
1,875
|
|
|
1,875
|
|
|
0
|
|
|
|
|
Robert
J. Sechan II
|
|
|
5,798
|
|
|
5,798
|
|
|
0
|
|
|
--
|
|
Robert
J. Whetten
|
|
|
11,596
|
|
|
11,596
|
|
|
0
|
|
|
--
|
|
Robert
J. Zappa
|
|
|
23,000
|
|
|
23,000
|
|
|
0
|
|
|
|
|
Robert
Klein
|
|
|
1,252
|
|
|
1,252
|
|
|
0
|
|
|
--
|
|
Robert
Masters
|
|
|
11,596
|
|
|
11,596
|
|
|
0
|
|
|
--
|
|
Robert
McEntire
|
|
|
10,000
|
|
|
10,000
|
|
|
0
|
|
|
--
|
|
Robert
Petrozzo
|
|
|
11,083
|
|
|
0
|
|
|
11,083
|
|
|
--
|
|
S.
Alan Lisenby
|
|
|
25,048
|
|
|
25,048
|
|
|
0
|
|
|
--
|
|
Sandgrain
Securities, Inc.
|
|
|
579
|
|
|
0
|
|
|
579
|
|
|
--
|
|
Sanford
Schwartz
|
|
|
25
|
|
|
25
|
|
|
0
|
|
|
|
|
Scot
Bryant
|
|
|
100
|
|
|
100
|
|
|
0
|
|
|
|
|
Scott
D. Whitaker
|
|
|
11,596
|
|
|
11,596
|
|
|
0
|
|
|
--
|
|
Scott
Katzmann
|
|
|
65,760
|
|
|
9,108
|
|
|
19,709
|
|
|
*
|
|
Scott
Shovea
|
|
|
50
|
|
|
50
|
|
|
0
|
|
|
--
|
|
Shea
Ventures, LLC
|
|
|
23,193
|
|
|
23,193
|
|
|
0
|
|
|
--
|
|
Shoup
Revocable Trust DTD April 29, 2003
|
|
|
11,597
|
|
|
11,597
|
|
|
0
|
|
|
--
|
|
Smithfield
Fiduciary LLC
|
|
|
512,708
|
|
|
231,931
|
|
|
0
|
|
|
1.78
|
% |
Stephen
C. Rabbitt
|
|
|
10,019
|
|
|
10,019
|
|
|
0
|
|
|
--
|
|
Stephen
H. Lebovitz
|
|
|
1,001
|
|
|
1,001
|
|
|
0
|
|
|
--
|
|
Stephen
N. Kitchens and Martha M. Kitchens JTWROS
|
|
|
11,193
|
|
|
11,193
|
|
|
0
|
|
|
--
|
|
Stephen
Rocamboli
|
|
|
51,039
|
|
|
40,677
|
|
|
0
|
|
|
*
|
|
Steven
A. Sherman
|
|
|
1,739
|
|
|
0
|
|
|
1,739
|
|
|
--
|
|
Steven
Lisi
|
|
|
14,027
|
|
|
14,027
|
|
|
0
|
|
|
--
|
|
Steven
Markowitz
|
|
|
6,480
|
|
|
0
|
|
|
6,480
|
|
|
--
|
|
Summit
Financial Relations Inc.
|
|
|
11,314
|
|
|
11,314
|
|
|
0
|
|
|
--
|
|
Susan
Schwartz
|
|
|
25
|
|
|
25
|
|
|
0
|
|
|
--
|
|
Suzanne
Schiller
|
|
|
5,009
|
|
|
5,009
|
|
|
0
|
|
|
--
|
|
Suzette
T. Seigel
|
|
|
5,798
|
|
|
5,798
|
|
|
0
|
|
|
--
|
|
The
Bahr Family Limited Partnership
|
|
|
11,596
|
|
|
11,596
|
|
|
0
|
|
|
--
|
|
The
Henry H. Bahr QTIP Trust Dated 2/22/88
|
|
|
11,596
|
|
|
11,596
|
|
|
0
|
|
|
--
|
|
The
Holding Company
|
|
|
4,383
|
|
|
4,383
|
|
|
0
|
|
|
--
|
|
The
Lindsay A. Rosenwald 2000 Irrevocable Trust U/A dated 5/24/2000
|
|
|
231,931
|
|
|
231,931
|
|
|
0
|
|
|
--
|
|
The
Lindsay Rosenwald 2000 Family Trust U/A dated 12/15/00
|
|
|
231,932
|
|
|
231,932
|
|
|
0
|
|
|
--
|
|
The
University of Texas M.D. Anderson
|
|
|
250,487
|
|
|
250,487
|
|
|
0
|
|
|
--
|
|
Thomas
B. Olson
|
|
|
5,000
|
|
|
5,000
|
|
|
0
|
|
|
--
|
|
Thomas
M. Vickers
|
|
|
5,000
|
|
|
5,000
|
|
|
0
|
|
|
--
|
|
Thomas
M. Vickers
|
|
|
5,250
|
|
|
5,250
|
|
|
0
|
|
|
--
|
|
Tim
P. Cooper
|
|
|
4,634
|
|
|
4,634
|
|
|
0
|
|
|
--
|
|
Timothy
McInerney
|
|
|
183,224
|
|
|
59,204
|
|
|
20,767
|
|
|
*
|
|
Timothy
S Greufe
|
|
|
150
|
|
|
150
|
|
|
0
|
|
|
--
|
|
Timothy
Shands
|
|
|
3,036
|
|
|
3,036
|
|
|
0
|
|
|
-
|
|
Tisu
Investment Ltd.
|
|
|
17,394
|
|
|
17,394
|
|
|
0
|
|
|
--
|
|
Tokenhouse
Trading Pte. Ltd.
|
|
|
46,386
|
|
|
46,386
|
|
|
0
|
|
|
--
|
|
Ursuline
Co.
|
|
|
12,524
|
|
|
12,524
|
|
|
0
|
|
|
--
|
|
Valeo
Partners, LLC
|
|
|
6,262
|
|
|
6,262
|
|
|
0
|
|
|
--
|
|
Vicki
D E Barone
|
|
|
25
|
|
|
25
|
|
|
0
|
|
|
*
|
|
VLA
LLP
|
|
|
50
|
|
|
50
|
|
|
0
|
|
|
*
|
|
Walter
B. Martin and Paloma Munoz JTWROS
|
|
|
5,798
|
|
|
5,798
|
|
|
0
|
|
|
--
|
|
Waterspout
Investments Pte Ltd
|
|
|
4,638
|
|
|
4,638
|
|
|
0
|
|
|
--
|
|
William
Corcoran
|
|
|
12,145
|
|
|
12,145
|
|
|
0
|
|
|
-
|
|
William
D. Cronin
|
|
|
100
|
|
|
100
|
|
|
0
|
|
|
*
|
|
William
McCahey and Lisa Krivacka JTWROS
|
|
|
5,798
|
|
|
5,798
|
|
|
0
|
|
|
--
|
|
William
R Going
|
|
|
25
|
|
|
25
|
|
|
0
|
|
|
*
|
|
William
S. Silver and Elinor Silver JTWROS
|
|
|
6,011
|
|
|
6,011
|
|
|
0
|
|
|
--
|
|
Wolcot
Capital, Inc.
|
|
|
24,048
|
|
|
24,048
|
|
|
0
|
|
|
--
|
|
Yitzhak
Nissan
|
|
|
1,252
|
|
|
1,252
|
|
|
0
|
|
|
--
|
|
|
|
|
|
|
|
6,658,295
|
|
|
482,407
|
|
|
|
|
(1) Beneficial
ownership is determined in accordance with SEC rules, beneficial ownership
includes any shares as to which the security or stockholder has sole or shared
voting power or investment power, and also any shares which the security or
stockholder has the right to acquire within 60 days of the date hereof, whether
through the exercise or conversion of any stock option, convertible security,
warrant or other right. The indication herein that shares are beneficially
owned
is not an admission on the part of the security or stockholder that he, she
or
it is a direct or indirect beneficial owner of those shares.
(2)
Assumes
sales of all shares by the selling stockholders.
(3) |
Includes
563,296 shares that the selling stockholder has the right to acquire
from
existing stockholders under certain circumstances pursuant to pledge
agreements between the selling stockholder and such existing
stockholders.
|
PLAN
OF DISTRIBUTION
We
are
registering the resale of certain shares of common stock offered by this
prospectus on behalf of the selling stockholders. As used in this prospectus,
the term “selling stockholders” include donees, pledges, transferees and other
successors in interest selling shares received from the selling stockholders
after the date of this prospectus, whether as a gift, pledge, partnership
distribution or other form of transfer. All costs, expenses and fees in
connection with the registration of the shares of common stock offered hereby
will be borne by the Company. Brokerage commissions and similar selling
expenses, if any, attributable to the sale of shares of common stock will be
borne by the selling stockholders.
Sales
of
shares of common stock offered hereby may be effected by the selling
stockholders from time to time in one or more types of transactions (which
may
include block transactions):
·
|
ordinary
brokerage transactions and transactions in which the broker-dealer
solicits purchasers;
|
·
|
block
trades in which the broker-dealer will attempt to sell the shares
as
agent, but may position and resell a portion of the block as principal
to
facilitate the transaction;
|
·
|
purchases
by a broker-dealer as principal and resale by the broker-dealer for
its
account;
|
·
|
an
exchange distribution in accordance with the rules of the applicable
exchange;
|
·
|
privately
negotiated transactions;
|
·
|
through
the writing or settlement of options or other hedging transactions,
whether through an options exchange or
otherwise;
|
·
|
broker-dealers
may agree with the selling stockholders to sell a specified number
of such
shares at a stipulated price per
share;
|
·
|
a
combination of any such methods of sale;
and
|
·
|
any
other method permitted pursuant to applicable
law.
|
The
selling stockholders may effect sales of shares of common stock offered hereby
at fixed prices, at prevailing market prices at the time of sale, at prices
related to the prevailing market price, at varying prices determined at the
time
of sale, or at privately negotiated prices. Any of these transactions may or
may
not involve brokers or dealers. Any such broker-dealers may receive compensation
in the form of discounts, concessions or commissions from the selling
stockholders and/or the purchaser(s) of shares of common stock for whom those
broker-dealers may act as agents or to whom they sell as principals, or both
(which compensation as to a particular broker-dealer might be in excess of
customary commissions). The selling stockholders have advised us that they
have
not entered into any agreements, understandings or arrangements with any
underwriters or broker-dealers regarding the sale of their securities, nor
is
there any underwriter or coordinating broker acting in connection with the
proposed sale of shares of common stock by the selling
stockholders.
The
selling stockholders may, from time to time, pledge or grant a security interest
in some or all of the shares of common stock owned by them and registered hereby
and, if any such selling stockholder defaults in the performance of its secured
obligations, the pledgees or secured parties may offer and sell the shares
of
common stock, from time to time, under this prospectus, or under an amendment
to
this prospectus or other applicable provision of the Securities Act amending
the
list of selling stockholders to include the pledgee, transferee or other
successors in interest as selling stockholders under this prospectus. The
selling stockholders also may transfer the shares of common stock in other
circumstances, in which case the transferees, pledgees or other successors
in
interest will be the selling beneficial owners for purposes of this
prospectus.
In
connection with the sale of our common stock or interests therein, the selling
stockholders may enter into hedging transactions with broker-dealers or other
financial institutions, which may in turn engage in short sales of the common
stock in the course of hedging the positions they assume. The selling
stockholders may also sell shares of our common stock short and deliver these
securities to close out their short positions, or loan or pledge the common
stock to broker-dealers that in turn may sell these securities. The selling
stockholders may also enter into option or other transactions with
broker-dealers or other financial institutions or the creation of one or more
derivative securities, which require the delivery to such broker-dealer or
other
financial institution of shares offered by this prospectus, which shares such
broker-dealer or other financial institution may resell pursuant to this
prospectus (as supplemented or amended to reflect such
transaction).
The
aggregate proceeds to the selling stockholders from the sale of the common
stock
offered by them will be the purchase price of the common stock less discounts
or
commissions, if any. The selling stockholders reserve the right to accept and,
together with their agents from time to time, to reject, in whole or in part,
any proposed purchase of common stock to be made directly or through agents.
We
will not receive any of the proceeds from this offering.
The
selling stockholders may also resell all or a portion of the shares in open
market transactions in reliance upon Rule 144 under the Securities Act, provided
that they meet the criteria and conform to the requirements of that
rule.
The
selling stockholders and any broker-dealers, agents or underwriters that
participate with the selling stockholders in the distribution of the issued
and
outstanding shares of common stock or the shares of stock issuable upon the
exercise of warrants may be deemed to be “underwriters” within the meaning of
the Securities Act, in which event any commissions received by these
broker-dealers, agents or underwriters and any profits realized by the selling
stockholders on the resales of the securities may be deemed to be underwriting
commissions or discounts under the Securities Act. If the selling stockholders
are deemed to be underwriters, the selling stockholders may be subject to
certain statutory and regulatory liabilities, including liabilities imposed
pursuant to Section 11, 12 and 17 of the Securities Act and Rule 10b-5 under
the
Exchange Act.
To
the
extent required, the shares of our common stock to be sold, the name of the
selling stockholders, the respective purchase prices and public offering prices,
the names of any agents, dealer or underwriter, any applicable commissions
or
discounts with respect to a particular offer will be set forth in an
accompanying prospectus supplement or, if appropriate, a post-effective
amendment to the registration statement that includes this
prospectus.
In
order
to comply with the securities laws of some states, if applicable, the common
stock may be sold in these jurisdictions only through registered or licensed
brokers or dealers. In addition, in some states the common stock may not be
sold
unless it has been registered or qualified for sale or an exemption from
registration or qualification requirements is available and is complied
with.
We
have
advised the selling stockholders that the anti-manipulation rules of Regulation
M under the Exchange Act may apply to sales of shares in the market and to
the
activities of the selling stockholders and their affiliates. In addition, we
will make copies of this prospectus (as it may be supplemented or amended from
time to time) available to the selling stockholders for the purpose of
satisfying the prospectus-delivery requirements of the Securities Act. The
selling stockholders may indemnify any broker-dealer that participates in
transactions involving the sale of the shares against certain liabilities,
including liabilities arising under the Securities Act.
We
are
unable to predict with certainty the effect which sales of the shares of common
stock offered by this prospectus might have upon our ability to raise additional
capital. Nevertheless, it is possible that the resale of shares offered hereby
could adversely affect the trading price of our common stock.
Shares
Eligible For Future Sale
Upon
completion of this offering and assuming the issuance of all of the shares
covered by this prospectus that are issuable upon the exercise of outstanding
warrants, there will be 15,746,655 shares of our common stock issued and
outstanding. The shares purchased in this offering will be freely tradable
without registration or other restriction under the Securities Act, except
for
any shares purchased by an “affiliate” of our Company (as defined under the
Securities Act).
Our
currently outstanding shares that were issued in reliance upon the “private
placement” exemptions provided by the Securities Act, including the 6,967,941
outstanding shares issued in connection with our September 13, 2005 merger
transaction with ZIOPHARM, Inc., and the 7,991,256 shares issued in connection
with our May 3, 2006 private placement transaction are deemed “restricted
securities” within the meaning of Rule 144. Restricted securities may not be
sold unless they are registered under the Securities Act or are sold pursuant
to
an applicable exemption from registration, including an exemption under Rule
144. In general, under Rule 144, any person (or persons whose shares are
aggregated) including persons deemed to be affiliates, whose restricted
securities have been fully paid for and held for at least one year from the
later of the date of issuance by us or acquisition from an affiliate, may sell
such securities in broker’s transactions or directly to market makers, provided
that the number of shares sold in any three-month period may not exceed the
greater of one percent of the then-outstanding shares of our common stock or
the
average weekly trading volume of our shares of common stock in the
over-the-counter market during the four calendar weeks preceding the sale.
Sales
under Rule 144 are also subject to certain notice requirements and the
availability of current public information about our Company. After two years
have elapsed from the later of the issuance of restricted securities by us
or
their acquisition from an affiliate, persons who are not affiliates under the
rule may sell such securities without any limitation. Assuming that all of
the
other requirements of Rule 144 are then satisfied, the 6,967,941 restricted
shares of our common stock that were issued in connection with the September
13,
2005 merger transaction will first be eligible for resale without registration
on September 13, 2006 and the 7,991,256 shares issued in our May 3, 2006 private
placement transaction will first be eligible for resale without registration
on
May 3, 2007.
Following
the date of this prospectus, we cannot predict the effect, if any, that sales
of
our common stock or the availability of our common stock for sale will have
on
the market price prevailing from time to time. Nevertheless, sales by existing
stockholders of substantial amounts of our common stock could adversely affect
prevailing market prices for our stock.
DISCLOSURE
OF COMMISSION POSITION ON
INDEMNIFICATION
FOR SECURITIES ACT LIABILITIES
Pursuant
to our certificate of incorporation and bylaws, we may indemnify an officer
or
director who is made a party to any proceeding, because of his position as
such,
to the fullest extent authorized by Delaware General Corporation Law, as the
same exists or may hereafter be amended. In certain cases, we may advance
expenses incurred in defending any such proceeding.
To
the
extent that indemnification for liabilities arising under the Securities Act
may
be permitted to directors, officers or persons controlling our company pursuant
to the foregoing provisions, or otherwise, 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. If a claim for indemnification against such liabilities (other
than the payment by us of expenses incurred or paid by a director, officer
or
controlling person of our company in the successful defense of any action,
suit
or proceeding) is asserted by any of our directors, officers or controlling
persons in connection with the securities being registered, we will, unless
in
the opinion of our counsel the matter has been settled by controlling precedent,
submit to a court of appropriate jurisdiction the question whether such
indemnification by us is against public policy as expressed in the Securities
Act and will be governed by the final adjudication of that issue.
ABOUT
THIS PROSPECTUS
This
prospectus is not an offer or solicitation in respect to these securities in
any
jurisdiction in which such offer or solicitation would be unlawful. This
prospectus is part of a registration statement that we filed with the Securities
and Exchange Commission. The registration statement that contains this
prospectus (including the exhibits to the registration statement) contains
additional information about our company and the securities offered under this
prospectus. That registration statement can be read at the SEC web site or
at
the SEC’s offices mentioned under the heading “Where You Can Find More
Information.” We have not authorized anyone else to provide you with different
information or additional information. You should not assume that the
information in this prospectus, or any supplement or amendment to this
prospectus, is accurate at any date other than the date indicated on the cover
page of such documents.
WHERE
YOU CAN FIND MORE INFORMATION
Before
you decide whether to invest in our common stock, you should read this
prospectus and the information we otherwise file with the Securities and
Exchange Commission, or the SEC. 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 an Internet site.
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
any
Current on Reports on Form 8-K filed under Item 12):
· |
Annual
Report on Form 10-KSB for the fiscal year ended December 31, 2005,
filed on March 20, 2006, as amended by Form 10-KSB/A filed on April
12,
2006;
|
· |
Quarterly
Report on Form 10-QSB for the quarter ended March 31, 2006,
filed on May 15, 2006;
|
· |
Current
Reports on Form 8-K filed on April 26, 2006 and May 3, 2006, respectively;
and
|
· |
Registration
Statement on Form SB-2 filed November 14, 2005, as amended by
Post-effective Amendment No. 1 to Form SB-2 filed April 3, 2006,
containing the description of capital stock as set forth in the section
entitled “Description of Capital Stock,” as such description is amended in
the section entitled “Description of Capital Stock” in Prospectus
Supplement No. 1 filed April 26, 2006 pursuant to Rule 424(b) promulgated
under the Securities Act of 1933, as
amended.
|
You
may
request a copy of these filings 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.
VALIDITY
OF COMMON STOCK
Legal
matters in connection with the validity of the shares offered by this prospectus
will be passed upon by Maslon Edelman Borman & Brand, LLP, Minneapolis,
Minnesota.
EXPERTS
The
financial statements of ZIOPHARM Oncology, Inc. as of and for the years ended
December 31, 2005 and 2004 and for the period from September 9, 2003 (date
of
inception) to December 31, 2003, included in this prospectus, have been included
herein in reliance on the report, dated March 9, 2006, of Vitale Caturano &
Company, Ltd., independent registered public accounting firm, given on the
authority of that firm as experts in auditing and accounting.
7,140,702
Shares
Common
Stock
ZIOPHARM
Oncology, Inc.
______________________
PROSPECTUS
______________________
2006
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item
14. Other Expenses Of Issuance And Distribution.
The
Registrant estimates that expenses payable by the Registrant is connection
with
the offering described in this Registration Statement will be as follows:
SEC
registration fee
|
|
$ |
10,358.42 |
|
Legal
fees and expenses
|
|
|
10,000.00 |
|
Accounting
fees and expenses
|
|
|
10,000.00 |
|
Printing
and engraving expenses
|
|
|
3,000.00 |
|
Miscellaneous
|
|
|
2,641.58 |
|
|
|
$ |
36,000.00 |
|
Item
15.
Indemnification of Directors and Officers.
The
Registrant’s amended and restated certificate of incorporation and bylaws
contain provisions indemnifying the Registrant’s directors and officers to the
fullest extent permitted by law. In addition, as permitted by Delaware law,
the
Registrant’s amended and restated certificate of incorporation provides that no
director will be liable to the Registrant or the Registrant’s stockholders for
monetary damages for breach of certain fiduciary duties as a director. The
effect of this provision is to restrict the Registrant’s rights and the rights
of its 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:
|
•
|
any
breach of his or her duty of loyalty to the Registrant or its
stockholders;
|
|
•
|
acts
or omissions not in good faith which involve intentional misconduct
or a
knowing violation of law;
|
|
•
|
the
payment of dividends or the redemption or purchase of stock in
violation
of Delaware law; or
|
|
•
|
any
transaction from which the director derived an improper personal
benefit.
|
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 our amended and restated 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 of 1933, as amended, and is therefore
unenforceable.
Section
145 of the Delaware General Corporation Law states:
(a) A
corporation shall have the power to indemnify any person who was or is a
party
or is threatened to be made a party to any threatened, pending or completed
action, suit or proceeding, whether civil, criminal, administrative or
investigative (other than an action arising by or in the right of the
corporation) by reason of the fact that he is or was a director, officer,
employee or agent of the corporation, or is or was serving at the request
of the
corporation as a director, officer, employee or agent of another corporation,
partnership, joint venture, trust or other enterprise, against expenses
(including attorneys’ fees), judgments, fines and amounts paid in settlement
actually and reasonably incurred by him in connection with such action, suit
or
proceeding if he acted in good faith and in a manner he reasonably believed
to
be in or not opposed to the best interests of the corporation, and, with
respect
to any criminal action or proceeding, had no reasonable cause to believe
his
conduct was unlawful. The termination of any action, suit or proceeding by
judgment, order, settlement, conviction, or upon a plea of nolo contendere
or
its equivalent, shall not, of itself, create a presumption that the person
did
not act in good faith and in a manner which he reasonably believed to be
in or
not opposed to the best interests of the corporation, and, with respect to
any
criminal action or proceeding, had reasonable cause to believe that his conduct
was unlawful.
(b) A
corporation shall have power to indemnify any person who was or is a party
or is
threatened to be made a party to any threatened, pending or completed action
or
suit by or in the right of the corporation to procure a judgment in its favor
by
reason of the fact that he is or was a director, officer, employee or agent
of
the corporation, or is or was serving at the request of the corporation as
a
director, officer, employee or agent of another corporation, partnership,
joint
venture, trust, or other enterprise against expenses (including attorneys’ fees)
actually and reasonably incurred by him in connection with the defense or
settlement of such action or suit if he acted in good faith and in a manner
he
reasonably believed to be in or not opposed to the best interests of the
corporation and except that no indemnification shall be made in respect to
any
claim, issue or matter as to which such person shall have been adjudged to
be
liable to the corporation unless and only to the extent that the Court of
Chancery or the court in which such action or suit was brought shall determine
upon application that, despite the adjudication of liability but in view
of all
the circumstances of the case, such person is fairly and reasonably entitled
to
indemnity for such expense which the Court of Chancery or such other court
shall
deem proper.
Item
16. Exhibits.
The
following exhibits are filed as part of this Registration Statement:
Exhibit
No.
|
Description
of Document
|
4.1
|
Form
of Warrant issued to placement agents in connection with ZIOPHARM,
Inc.
2005 private placement (incorporated by reference to Exhibit 4.2
to the
Registrant’s Registration Statement on Form SB-2 (SEC File No. 333-129020)
filed October 14, 2005).
|
4.2
|
Schedule
identifying holders of Warrants in the form filed as Exhibit 4.1
to this
Report (incorporated by reference to Exhibit 4.3 to the Registrant’s
Registration Statement on Form SB-2 (SEC File No. 333-129020) filed
October 14, 2005).
|
4.3
|
Warrant
for the Purchase of Shares of Common Stock dated December 23, 2004
(incorporated by reference to Exhibit 4.4 to the Registrant’s Registration
Statement on Form SB-2 (SEC File No. 333-129020) filed October
14,
2005).
|
4.4
|
Option
for the Purchase of Common Stock dated October 15, 2004 and issued
to
DEKK-Tec, Inc. (incorporated by reference to Exhibit 4.5 to the
Registrant’s Annual Report on Form 10-KSB filed (SEC File No. 000-32353)
March 20, 2006).
|
4.5
|
Form
of Option for the Purchase of Shares of Common Stock dated August
30, 2004
and issued to The University of Texas M.D. Anderson Cancer Center.
(incorporated by reference to Exhibit 4.6 to the Registrant’s Annual
Report on Form 10-KSB filed (SEC File No. 000-32353) March 20,
2006).
|
4.6
|
Schedule
identifying material terms of Options for the Purchase of Shares
of Common
Stock in the form filed as Exhibit 4.5 to this Report (incorporated
by
reference to Exhibit 4.7 to the Registrant’s Annual Report on Form 10-KSB
filed (SEC File No. 000-32353) March 20, 2006).
|
5.1
|
Legal
opinion of Maslon Edelman Borman & Brand, LLP (incorporated by
reference to Exhibit 5.1 to the Registrant's Registration Statement
on
Form SB-2 (File No. 333-129020)).
|
5.2
|
Legal opinion
of Maslon
Edelman Borman & Brand, LLP (incorporated by reference to Exhibit 5.1
to the Registrant's Registration Statement on Form SB-2 (File No.
333-129680)). |
23.1
|
Consent
of Independent Registered Public Accounting Firm - Vitale, Caturano
&
Company, Ltd.
|
23.2
|
Consent
of Maslon Edelman Borman & Brand, LLP (included as part of Exhibit
5.1).
|
24.1
|
Power
of Attorney (included on signature
page).
|
Item
17.
Undertakings.
The
undersigned Registrant hereby undertakes:
(1)
To
file, during any period in which offers or sales are being made, a
post-effective amendment to this registration statement:
(i)
To
include any prospectus required by Section 10(a)(3) of the Securities Act
of 1933;
(ii)
To
reflect in the prospectus any facts or events arising after the effective
date
of the registration statement (or the most recent post-effective amendment
thereof) which, individually or in the aggregate, represent a fundamental
change
in the information set forth in the registration statement. Notwithstanding
the
foregoing, any increase or decrease in volume of securities offered (if the
total dollar value of securities offered would not exceed that which was
registered) and any deviation from the low or high end of the estimated maximum
offering range may be reflected in the form of prospectus filed with the
Securities and Exchange Commission pursuant to Rule 424(b) if, in the aggregate,
the changes in volume and price represent no more than a 20% change in the
maximum aggregate offering price set forth in the “Calculation of Registration
Fee” table in the effective registration statement;
(iii)
To
include any material information with respect to the plan of distribution
not
previously disclosed in the registration statement or any material change
to
such information in the registration statement;
Provided,
however, that paragraphs (1)(i), (1)(ii) and (1)(iii) of this section do
not
apply if the registration statement is on Form S-3 or Form F-3 and the
information required to be included in a post-effective amendment by those
paragraphs is contained in reports filed with or furnished to the Securities
and
Exchange Commission by the registrant pursuant to Section 13 or Section
15(d) of the Securities Exchange Act of 1934 that are incorporated by reference
in the registration statement, or is contained in a form of prospectus filed
pursuant to Rule 424(b) that is part of the registration statement.
(2)
That,
for the purpose of determining any liability under the Securities Act of
1933,
each such post-effective amendment shall be deemed to be a new registration
statement relating to the securities offered therein, and the offering of
such
securities at that time shall be deemed to be the initial bona fide offering
thereof.
(3)
To
remove from registration by means of a post-effective amendment any of the
securities being registered which remain unsold at the termination of the
offering.
(4)
That,
for the purpose of determining liability under the Securities Act of 1933
to any
purchaser:
(i)
If
the registrant is relying on Rule 430B:
(A)
Each
prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be
deemed to be part of the registration statement as of the date the filed
prospectus was deemed part of and included in the registration statement;
and
(B)
Each
prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or
(b)(7) as part of a registration statement in reliance on Rule 430B
relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or
(x) for the purpose of providing the information required by section 10(a)
of the Securities Act of 1933 shall be deemed to be part of and included
in the
registration statement as of the earlier of the date such form of prospectus
is
first used after effectiveness or the date of the first contract of sale
of
securities in the offering described in the prospectus. As provided in
Rule 430B, for liability purposes of the issuer and any person that is at
that date an underwriter, such date shall be deemed to be a new effective
date
of the registration statement relating to the securities in the registration
statement to which that prospectus relates, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering thereof.
Provided, however, that no statement made in a registration statement or
prospectus that is part of the registration statement or made in a document
incorporated or deemed incorporated by reference into the registration statement
or prospectus that is part of the registration statement will, as to a purchaser
with a time of contract of sale prior to such effective date, supersede or
modify any statement that was made in the registration statement or prospectus
that was part of the registration statement or made in any such document
immediately prior to such effective date; or
(ii)
If
the registrant is subject to Rule 430C, each prospectus filed pursuant to
Rule 424(b) as part of a registration statement relating to an offering,
other
than registration statements relying on Rule 430B or other than
prospectuses filed in reliance on Rule 430A, shall be deemed to be part of
and included in the registration statement as of the date it is first used
after
effectiveness. Provided, however, that no statement made in a registration
statement or prospectus that is part of the registration statement or made
in a
document incorporated or deemed incorporated by reference into the registration
statement or prospectus that is part of the registration statement will,
as to a
purchaser with a time of contract of sale prior to such first use, supersede
or
modify any statement that was made in the registration statement or prospectus
that was part of the registration statement or made in any such document
immediately prior to such date of first use.
The
undersigned registrant hereby undertakes that, for purposes of determining
any
liability under the Securities Act of 1933, each filing of the registrant’s
annual report pursuant to Section 13(a) or 15(d) of the Securities Exchange
Act
of 1934 (and, where applicable, each filing of an employee benefit plan’s annual
report pursuant to Section 15(d) of the Securities Exchange Act of 1934)
that is
incorporated by reference in the registration statement shall be deemed to
be a
new registration statement relating to the securities offered therein, and
the
offering of such securities at that time shall be deemed to be the initial
bona
fide offering thereof.
Insofar
as indemnification for liabilities arising under the Securities Act of 1933
may
be permitted to directors, officers and controlling persons of the registrant
pursuant to the foregoing provisions, or otherwise, the registrant has 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. In the event that a claim for indemnification
against such liabilities (other than the payment by the registrant of expenses
incurred or paid by a director, officer or controlling person of the registrant
in the successful defense of any action, suit or proceeding) is asserted
by such
director, officer or controlling person in connection with the securities
being
registered, the registrant will, unless in the opinion of its counsel the
matter
has been settled by controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is against public
policy as expressed in the Securities Act and will be governed by the final
adjudication of such issue.
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, the Registrant certifies
that
it has reasonable grounds to believe that it meets all of the requirements
for
filing on Form S-3 and has duly caused this registration statement to be
signed
on its behalf by the undersigned, thereunto duly authorized, in the City
of New
York, State of New York, on June 30, 2006.
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|
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ZIOPHARM
Oncology,
Inc. |
|
|
|
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By: |
/s/ Jonathan
Lewis |
|
Jonathan
Lewis |
|
Chief
Executive Officer |
POWER
OF ATTORNEY
Each
person whose signature appears below hereby constitutes and appoints Jonathan
Lewis and Richard E. Bagley, and each of them, as his true and lawful
attorneys-in-fact and agents, with full power of substitution and
resubstitution, for him and in his name, place and stead, in any and all
capacities, to sign any and all amendments (including post-effective amendments)
to this registration statement, and to file the same, with all exhibits thereto,
and other documents in connection therewith, with the Securities and Exchange
Commission, granting unto said attorneys-in-fact and agents, full power and
authority to do and perform each and every act and thing requisite and necessary
to be done in connection therewith, as fully to all intents and purposes
as he
might or could do in person, hereby ratifying and confirming all that said
attorney-in-fact and agent or his substitutes or substitute, may lawfully
do or
cause to be done by virtue hereof.
Pursuant
to the requirements of the Securities Act of 1933, this registration statement
has been signed by the following persons in the capacities and on the dates
indicated.
Name
|
|
Title
|
Date
|
|
|
|
|
/s/
Jonathan Lewis
Jonathan
Lewis
|
|
Director
and Chief Executive Officer
(Principal
Executive Officer)
|
June
30, 2006
|
|
|
|
|
/s/
Richard Bagley
Richard
E. Bagley
|
|
Director,
President, Treasurer and Chief Operating
Officer
(Principal
Accounting and Financial
Officer)
|
June
30, 2006
|
|
|
|
|
Murray
Brennan
|
|
Director
|
June
30, 2006
|
|
|
|
|
/s/
James Cannon
James
Cannon
|
|
Director
|
June
30, 2006
|
|
|
|
|
/s/
Timothy McInerney
Timothy
McInerney
|
|
Director
|
June
30, 2006
|
|
|
|
|
/s/
Wyche Fowler, Jr.
Wyche
Fowler, Jr.
|
|
Director
|
June
30, 2006
|
|
|
|
|
Gary
S. Fragin
|
|
Director
|
June
30, 2006
|
|
|
|
|
Michael
Weiser
|
|
Director
|
June
30, 2006
|
EXHIBIT
INDEX
Exhibit
No.
|
Description
of Document
|
|
|
23.1
|
Consent
of Independent Registered Public Accounting Firm - Vitale, Caturano
&
Company, Ltd.
|