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): May 12, 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
May
12, 2008, ZIOPHARM Oncology, Inc. issued a press release announcing its
financial results for the quarter ended March 31, 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 May 12, 2008.
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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By:
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/s/
Richard E. Bagley
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Name:
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Richard
E. Bagley
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Title:
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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 May 12, 2008.
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Exhibit
99.1
ZIOPHARM
Oncology Reports First Quarter Results
NEW
YORK – May 12, 2008 - ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP) today reported
financial results for the three months ended March 31, 2008.
The
Company reported a net loss for the first quarter of 2008 of $8.6 million,
or
$(0.41) per share, compared with a net loss for the first quarter of 2007 of
$5.0 million, or $(0.29) per share. Total operating expenses for the quarter
were $8.8 million, compared with $5.4 million for the same quarter in the prior
year. The increase was primarily due to higher costs associated with the
continual progress in the clinical development of ZIO-101 (darinaparsin),
ZIO-201 (IPM) and ZIO-301 (indibulin). Cash used in operations during the first
quarter 2008 was $7.5 million, compared with $4.5 million used in the first
quarter 2007.
Highlights
since the beginning of the first quarter 2008 included:
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·
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First
patient treatment in two combination therapy studies, including a
phase
I/II combination study evaluating oral indibulin combined with oral
Tarceva® (erlotinib) in the treatment of patients with solid tumors, and a
phase I/II study of palifosfamide (ZIO-201) used in combination with
Adriamycin® (doxorubicin) in the treatment of patients with sarcoma.
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·
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Presentation
of promising early data from phase Ib study of indibulin at 6th
International Symposium on Targeted Anticancer Therapies; results
demonstrated that indibulin is well tolerated and active among eight
evaluable patients. Results included a complete response in Ewing's
Sarcoma and a partial response in a neuroendocrine cancer as evaluated
by
PET scan.
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·
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Subsequent
to the quarter in early April, presentation of positive data from
phase II
study of darinaparsin in advanced hematological malignancies at AACR
2008
Annual Meeting; where therapy with darinaparsin was well tolerated
and,
among 7 lymphoma patients evaluable for efficacy, 1 patient with
peripheral T-cell lymphoma achieved a complete response, one patient
with
nodular sclerosis achieved an interval response, and one patient
with
B-cell lymphoma achieved stable disease and, among 14 leukemia patients
evaluable for efficacy, 6 patients achieved stable
disease.
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Jonathan
Lewis, MD, PhD, Chief Executive Officer of ZIOPHARM, commented, “From study
initiations to data presentations, we continued to make important progress
in
our clinical programs throughout the first quarter. At the same time, we have
taken a disciplined approach to expense management and are exploring options
such as randomized phase II studies and development partnerships to maintain
progress in our clinical development while maximizing the use of our
cash.”
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, including the related material at www.ziopharm.com,
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
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