UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(d) OF
THE
SECURITIES EXCHANGE ACT OF 1934
Date
of
report (date of earliest event reported): November 2, 2007
ZIOPHARM
Oncology, Inc.
(Exact
name of registrant as specified in its charter)
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Delaware
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0-32353
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84-1475642
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(State
or other jurisdiction of incorporation)
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(Commission
File Number)
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(IRS
Employer Identification No.)
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1180
Avenue of the Americas, 19th
Floor
New
York, NY 10036
(Address
of principal executive offices) (Zip Code)
(646)
214-0700
(Registrant’s
telephone number, including area code)
(Former
name or former address, if changed since last report)
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
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o
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Written
communications pursuant to Rule 425 under the Securities Act (17
CFR
230.425)
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o
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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o
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR
240.14d-2(b))
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o
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR
240.13e-4(c))
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Item
8.01. Other Events.
On
November 2, 2007 and November 5, 2007, ZIOPHARM Oncology, Inc. issued the press
releases attached hereto as Exhibits 99.1 and 99.2, respectively, which are
incorporated herein by reference.
Item
9.01 Financial Statements and Exhibits.
(d) Exhibits.
99.1 Press
Release dated November 2, 2007.
99.2 Press
Release dated November 5, 2007.
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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ZIOPHARM
Oncology, Inc.:
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(Registrant)
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Date:
November 5, 2007
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By:
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/s/ Richard E. Bagley
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Richard
E. Bagley,
President,
Chief Operating Officer and Chief Financial
Officer
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Exhibit
Index
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Exhibit
No.
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Description
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99.1
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Press
Release dated November 2, 2007.
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99.2
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Press
Release dated November 5,
2007.
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Exhibit
99.1
ZIOPHARM
Oncology Reports Third Quarter Results
NEW
YORK (November 02, 2007)
-
ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP), a biopharmaceutical company engaged
in
the development and commercialization of a diverse, risk-sensitive portfolio
of
in-licensed cancer drugs to address unmet medical needs, today reported
financial results for the three and nine months ended September 30,
2007.
The
Company reported a net loss for the third quarter of 2007 of $7.3 million,
or
$(0.35) per share, compared with a net loss for the third quarter of 2006 of
$3.5 million, or $(0.23) per share. Total operating expenses for the quarter
were $7.9 million, compared with $3.9 million for the same quarter in the prior
year. The increase was primarily due to higher expenses associated with the
continued clinical development of ZIO-101 (darinaparsin), ZIO-201 (IPM) and
ZIO-301 (indibulin). Cash used in operations during the third quarter 2007
was
$5.6 million, compared with $2.6 million used in the third quarter
2006.
For
the
first nine months of 2007 the Company reported a net loss of $18.9 million,
or
$(0.94) per share, compared with a net loss of $12.0 million, or $(1.03) per
share for the same period of 2006. Total operating expenses for the nine months
ended September 30, 2007 were $20.5 million, compared with $12.9 million for
the
comparable prior-year period. Cash used in operations for the first nine months
of 2007 was $15.8 million, compared with $8.5 million used in the same period
of
2006. As of September 30, 2007 ZIOPHARM had cash and cash equivalents of $40.9
million, compared with $26.9 million as of December 31, 2006.
Highlights
since the beginning of the third quarter 2007 included:
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·
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Presentation
of positive phase II ZIO-201 interim sarcoma data at the European
Society
for Medical Oncology (ESMO), which demonstrated clinical benefit
and
showed ZIO-201 to be well tolerated at the phase II dose with no
significant bone marrow suppression, alopecia (hair loss) or neurotoxicity
reported;
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·
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Initiation
of patient dosing in a U.S. phase I trial of oral darinaparsin (ZIO-101)
to treat solid tumors;
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·
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Allowance
of patent claims for darinaparsin (ZIO-101), which cover all oral
formulations of organic arsenic;
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·
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Presentation
of phase II clinical data for ZIO-201 (IPM) at the 14th
Annual European Cancer Conference (ECCO), which demonstrated a clinically
beneficial response and tolerability with adverse events primarily
mild to
moderate;
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·
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Presentation
of positive clinical data of darinaparsin (ZIO-101) at the 14th
Annual European Cancer Conference (ECCO), which showed clinical activity
in patients with advanced hematological malignancies and, importantly,
showed darinaparsin to be well tolerated, particularly with regard
to
cardiac toxicity, and adverse events were mild to moderate in
severity.
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Jonathan
Lewis, MD, PhD, Chief Executive Officer of ZIOPHARM, commented, “In the third
quarter, we accomplished significant clinical progress with all three of our
product candidates and remain encouraged by the flow of positive data that
have
been presented at leading medical and scientific meetings. We were
especially pleased with the interim results from the ongoing phase II trial
with
ZIO-201 in patients with advanced sarcoma.”
About
ZIOPHARM Oncology
ZIOPHARM
Oncology, Inc. is a biopharmaceutical company engaged in the development and
commercialization of a diverse, risk-sensitive portfolio of in-licensed cancer
drugs to address unmet medical needs. The Company applies new insights from
molecular and cancer biology to understand the efficacy and safety limitations
of approved and developmental cancer therapies, and identifies proprietary
and
related molecules for better patient treatment. For more information, visit
www.ziopharm.com.
Forward-Looking
Statements
This
news
release contains forward-looking statements based on current expectations,
forecasts and assumptions that are subject to risks and uncertainties that
could
cause actual outcomes and results to differ materially from these statements.
Among other things, there can be no assurance that any of the Company's
development efforts relating to its product candidates will be successful,
or
that such product candidates will be successfully commercialized. Other risks
that affect forward-looking information contained in this news release include
the possibility of being unable to obtain regulatory approval of the Company's
product candidates, the risk that the results of clinical trials may not support
the Company's claims, and risks related to the Company's ability to protect
its
intellectual property and its reliance on third parties to develop its product
candidates. The Company assumes no obligation to update these forward-looking
statements, except as required by law. For further risk factors see the
Company's 10-KSB filed with the SEC.
ZIOP-G
CONTACTS:
Investors:
ZIOPHARM
Oncology, Inc.
Suzanne
McKenna, Investor Relations
646-214-0703
smckenna@ziopharm.com
Argot
Partners
Andrea
Rabney, 212-600-1902
andrea@argotpartners.com
Exhibit
99.2
ZIOPHARM
Presents Positive Phase II Data for ZIO-201 in Soft Tissue and Bone Sarcomas
at
Connective Tissue Oncology Society (CTOS) Annual Meeting
Data
Support Development of Randomized Phase III Study for
2008
NEW
YORK, New York, November 5, 2007 -
ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP) announced today the presentation of
positive data from an ongoing Phase II study of ZIO-201 used in soft tissue
and
bone sarcomas at the Connective Tissue Oncology Society (CTOS) Annual Meeting
which was held in Seattle, Washington from November 1-3, 2007.
The
Phase
I/II study in advanced/unresectable soft tissue and bone sarcomas, including
a
diverse range of histological subtypes, has been fully enrolled at 54 patients,
with 50 in Phase II as reported on at CTOS. Of
44
evaluable patients, 48% had stable disease or better with a median progression
free survival of 10 weeks. Among the 11 patients enrolled in the study who
had
not previously received the chemotherapy agent ifosfamide (IFOS), stable
disease
or better was reported in 64% of patients and the median progression free
survival has not yet been reached.
The
most
common toxicities were mild to moderate and gastrointestinal or renal related,
with no reports of central nervous system or bladder toxicities and no
significant bone marrow suppression or alopecia. Data from the study support
the
Company’s plans for the development and initiation of a randomized Phase III
study of ZIO-201 in 2008.
“Progression
free survival rates reported in this study compare favorably to rates reported
for historical controls with fewer serious toxicities and a convenient dosing
schedule,” stated Rashmi Chugh, MD, Principal Investigator of the study and
faculty at the University of Michigan. “These data are interesting, particularly
in heavily pre-treated patients, and support further evaluation of
ZIO-201.”
“Bone
and
soft tissue sarcomas are less common cancers and, unfortunately, patients
suffering from advanced forms of the diseases have poor prognoses and no
FDA
approved treatment options,” stated Jonathan Lewis, MD, PhD, Chief Executive
Officer of ZIOPHARM Oncology. “In addition, current treatments, particularly
ifosfamide, carry with them a significant level of toxicity that can result
in
debilitating side effects. Based on data from this study, we are optimistic
about ZIO-201 as a potential treatment option for sarcomas and will work
closely
with the medical and regulatory communities as we develop our Phase III trial
approach.”
The
trial
was a 2-stage Simon design, with ZIO-201 administered daily for 3 consecutive
days every 3 weeks for up to 6 cycles or until disease progression or
unacceptable toxicity occurs. All evaluable patients had baseline ECOG
scores of less than 2 and the median number of prior chemotherapies was 5.
76% of patients had previously received IFOS.
About
ZIO-201
ZIO-201,
the active moiety of ifosfamide (IFOS), is a bi-functional alkylator that
causes
irreparable inter-strand DNA cross-linking resulting in cell death. ZIO-201
is
equal to or more active than IFOS in diverse cancer models. Unlike IFOS,
which
is a pro-drug, ZIO-201 is directly active against cancer cells. Also, unlike
IFOS, ZIO-201 is not metabolized to acrolein or chloroacetaldehyde which
cause
bladder or central nervous system toxicities. ZIO-201 continues in a Phase
II
trial in advanced sarcoma. Trials in ovarian and pediatric cancers are in
the
planning stage. An oral form of ZIO-201 is in advanced preclinical
development.
About
ZIOPHARM Oncology, Inc.
ZIOPHARM
Oncology, Inc. is a biopharmaceutical company engaged in the development
and
commercialization of a diverse, risk-sensitive portfolio of in-licensed cancer
drugs to address unmet medical needs. The
Company applies new insights from molecular and cancer biology to understand
the
efficacy and safety limitations of approved and developmental cancer therapies
and identifies proprietary and related molecules for better patient treatment.
For more information, visit www.ziopharm.com.
Forward-Looking
Safe Harbor Statement:
This
press release contains forward-looking statements for ZIOPHARM Oncology,
Inc.
that involve risks and uncertainties that could cause the Company's actual
results to differ materially from the anticipated results and expectations
expressed in these forward-looking statements. These statements are based
on
current expectations, forecasts and assumptions that are subject to risks
and
uncertainties, which could cause actual outcomes and results to differ
materially from these statements. Among other things, there can be no assurance
that any of the Company's development efforts relating to its product candidates
will be successful, or such product candidates will be successfully
commercialized. Other risks that affect forward-looking information contained
in
this press release include the possibility of being unable to obtain regulatory
approval of the Company's product candidates, the risk that the results of
clinical trials may not support the Company's claims, and risks related to
the
Company's ability to protect its intellectual property and its reliance on
third
parties to develop its product candidates. The Company assumes no obligation
to
update these forward-looking statements, except as required by law.
ZIOP-G
CONTACT:
ZIOPHARM
Oncology, Inc.
Suzanne
McKenna, 646-214-0703
smckenna@ziopharm.com
Argot
Partners
Andrea
Rabney, 212-600-1902
andrea@argotpartners.com