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): October 31, 2008
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:
o Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
o Soliciting
material pursuant to Rule 14a-12 under
the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement
communications pursuant to Rule
14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement
communications pursuant to Rule
13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item
2.02. Results of Operations and Financial Condition.
On
October 31, 2008, ZIOPHARM Oncology, Inc. issued a press release announcing
its
financial results for the three and nine-month periods ended September 30,
2008.
A copy of the press release is attached hereto as Exhibit 99.1, which is
incorporated herein by reference.
Item
9.01. Financial Statements and Exhibits.
(d) Exhibits.
99.1 Press
Release dated October 31, 2008.
SIGNATURES
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.:
(Registrant)
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| Date: October 31, 2008 | By: | /s/ Richard E. Bagley |
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Name: Richard E. Bagley |
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| Title: President and Chief Operating Officer | ||
Exhibit
99.1
ZIOPHARM
ONCOLOGY REPORTS THIRD QUARTER FINANCIAL RESULTS
NEW
YORK - OCTOBER 31, 2008
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ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) announced today its financial results
for
the three and nine-month period ending September 30, 2008.
The
Company reported a lower net loss for the third quarter of 2008 of $5.5 million,
or $(0.26) per share, compared with a net loss for the third quarter of 2007
of
$7.3 million, or $(0.35) per share. Total operating expenses for the quarter
were $5.6 million, compared with $7.9 million for the same quarter in the prior
year. The decrease was primarily due to a reduction in product manufacturing
for
darinaparsin and palifosfamide, decreased enrollment numbers for the
darinaparsin clinical trials, and a program to efficiently manage
costs. Cash
used
in operations during the third quarter 2008 increased by $0.4 million to $5.9
million compared with $5.5 million used in the third quarter 2007 as a result
of
upfront payments to contract organizations responsible for the recently
initiated Phase II randomized controlled trial for palifosfamide.
The
Company reported a net loss in the nine-month period ended September 30, 2008
of
$20.7 million, or $(0.97) per share, compared with a net loss of $18.9 million,
or $(0.94) per share, in the same period of the prior year. Total operating
expenses for the nine months ended September 30, 2008 were $21.1 million
compared with total operating expenses of $20.5 million in the same period
in
the prior year. Cash used in operations was $19.7 million for the first nine
months of 2008 compared with $15.8 million used in the same period of 2007.
The
Company ended the nine-month period with approximately $15.2 million in cash
and
cash equivalents on hand. In order to preserve capital while maximizing
opportunities from its product portfolio, the Company has reduced staff, most
recently eight positions, and other project and personnel-related expenses
and
has focused its product priorities on (i) the palifosfamide Phase II randomized
controlled trial with intravenous administration; (ii) the ongoing Phase I/II
oral indibulin trials; (iii) the completion of preclinical studies regarding
dose dense and metronomic dosing of indibulin; and (iv) the partnering for
further development of darinaparsin with both the IV and oral forms. With
expense management and focus on these priorities, the Company currently has
sufficient capital to fund the development programs for palifosfamide and
indibulin into the first quarter of 2010.
Highlights
for the third quarter 2008 included:
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Publication
of results from preclinical study of darinaparsin in the July 17,
2008
online advance publication issue of Leukemia, a Nature Publication.
The
study showed that darinaparsin is highly active in
vitro against
certain leukemia cells that are resistant to inorganic arsenic (arsenic
trioxide - ATO) because they express a drug resistance protein
(MRP1/ABCC1).
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Received
further Notices of Allowance from European and U.S. Patents covering
indibulin.
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Commenced
international Phase II randomized controlled trial of palifosfamide
in
patients with soft-tissue sarcoma (STS). The Phase II trial will
evaluate
the clinical benefit of palifosfamide administered with doxorubicin
compared with single-agent doxorubicin in subjects diagnosed with
respectable or metastatic STS in the front- or second-line treatment
setting. The primary endpoint is assessment of the difference in
progression-free survival between subjects in the two arms of the
trial.
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About
ZIOPHARM Oncology, Inc.:
ZIOPHARM
Oncology is a biopharmaceutical company engaged in the development and
commercialization of a diverse portfolio of cancer drugs. The Company is
currently focused on three clinical programs.
Palifosfamide
(ZIO-201) is a novel molecule that is the functional active metabolite of
ifosfamide, a standard of care for treating sarcoma, testicular and other
cancers. Palifosfamide delivers only the cancer fighting component of
ifosfamide. It is expected to overcome the resistance of ifosfamide and
cyclophosphamide in certain cancers. It does not have the toxic metabolites
of
ifosfamide that cause the debilitating side effects of “fuzzy brain”
(encephalopathy) and severe bladder inflammation. Intravenous (IV) palifosfamide
is currently in a Phase II randomized trial to treat soft tissue sarcoma. An
oral form of palifosfamide has been developed preclinically and is expected
to
enter clinical study in 2009.
Indibulin
(ZIO-301) is a novel, oral tubulin binding agent that targets both mitosis
and
cancer cell migration. Indibulin is expected to have several potential benefits,
including oral dosing, application in multi-drug resistant tumors, no neuropathy
and minimal overall toxicity. Indibulin has shown early activity in Phase I
study as a single agent in many types of solid tumors. Indibulin is also
currently in the Phase I portion of Phase I/II trials in combination with
Tarceva® and Xeloda®. Preclinical study continues with both dose density and
metronomic administration.
Darinaparsin
(ZIO-101) is a novel organic arsenic being developed for the treatment of
various hematologic and solid cancers. Preclinical and Phase I and II results
to
date demonstrate that darinaparsin is much less toxic than other forms of
arsenic. Intravenous darinaparsin continues to be studied in a Phase II
hematology trial with favorable treatment activity in certain lymphomas and
in
Phase I study with oral administration. Darinaparsin has been well tolerated
in
all trials to date.
ZIOPHARM’s
operations are located in Boston, MA with an executive office in New
York.
Further
information about ZIOPHARM may be found at www.ziopharm.com.
ZIOP-E
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.
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Contacts:
Tyler
Cook
ZIOPHARM
Oncology, Inc.
(617)
259-1982
tcook@ziopharm.com
or
Melody
Carey
Rx
Communications Group
(917)
322-2571
mcarey@rxir.com