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 15,
2009
(Exact
Name of Registrant as Specified in Charter)
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Delaware
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0-32353
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84-1475672
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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
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10036
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(Address
of Principal Executive Offices)
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(Zip
Code)
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(646) 214-0700
(Registrant’s
telephone number, including area code)
Not
applicable
(Former
Name or Former Address, if Changed Since Last Report)
Check the
appropriate box below if the Form 8-K 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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Results of Operations and Financial
Condition
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On May
15, 2009, ZIOPHARM Oncology, Inc. (the “Company”) issued a press release
announcing its financial condition and results of operations for the three
months ended March 31, 2009. A copy of the press release is furnished as
Exhibit 99.1 and is incorporated herein by reference.
The press
release is furnished pursuant to Item 2.02 of this Current Report on Form 8-K
and shall not be deemed “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the
liabilities of that Section, nor shall such document be deemed incorporated by
reference in any filing under the Securities Act of 1933 or the Exchange
Act.
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Financial Statements and
Exhibits
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(d)
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Exhibits
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Exhibit No.
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Description
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99.1
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Press
Release of the Company dated May 15,
2009
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2
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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.
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By:
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/s/
Richard Bagley
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Date:
May 15, 2009
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Name:
Richard Bagley
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Title:
President, Chief Operating Officer and Chief Financial
Officer
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3
INDEX OF
EXHIBITS
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Exhibit No.
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Description
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99.1
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Press
Release of the Company dated May 15,
2009
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4
Exhibit
99.1
ZIOPHARM
REPORTS FIRST QUARTER FINANCIAL RESULTS
--Updates
Continued Clinical Development Progress--
NEW YORK, NY – May 15, 2009 -
ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), a biopharmaceutical company that is
seeking to develop and commercialize a diverse, risk sensitive portfolio of
in-licensed cancer drugs addressing unmet medical needs, today reported its
financial results for the three months ended March 31, 2009 and updated the
Company’s continued progress with its clinical programs.
The
Company reported a net loss and operating expenses for the first quarter 2009 of
$3.3 million, or $(0.16) per share, compared with a net loss and operating
expenses for the first quarter of 2008 of $8.6 million, or $(0.41) per share,
and $8.8 million. The Company invests its cash only in U.S. treasuries and
therefore interest income for the first quarter of this year was diminumus,
resulting in the same number for operating expenses and net loss. The
significant decrease in operating expenses is attributable to a continuing focus
of resources as well as tight management of operating expenses. For the first
quarter of 2009, as compared to 2008, Research and Development expenses declined
$4.5 million while General and Administrative expenses declined by $1 million.
Net cash used in operations was $4.6 million in the first quarter of 2009 as
compared with $7.5 during the comparable 2008 period. The decrease in net cash
used in operations was attributable to a decrease in net loss from operations of
$5.3 million. This was partially offset by changes in accounts payable and
accruals of $2.3 million, which went from an increase of $425,000 in the first
quarter of 2008 to a decrease of $1.9 million in the first quarter of 2009. This
abrupt change in short-term liabilities is not expected to be repeated in future
quarters. The Company ended the March 2009 quarter with approximately $6.8
million which is expected to support operations well into the second quarter of
2010.
Enrollment
in the first quarter for the palifosfamide randomized Phase II trial in the
United States and Europe has progressed well ahead of the Company’s
expectations. The purpose of the Phase II trial is to generate data in a
randomized controlled setting that would establish the criteria for the Company
to confer with the U.S. Food and Drug Administration on the design of a
registration trial that the Company expects could initiate as early as the first
half of 2010.
Progress
for all three of the Company’s clinical-stage compounds has been recognized with
acceptance for presentation at the American Society for Clinical Oncology (ASCO)
Annual Meeting in June, including an oral presentation for darinaparsin
(ZinaparTM or
ZIO-101) at the prestigious and select Clinical Science Symposium. Clinical
Science Symposia are high-profile sessions that incorporate the presentation of
meritorious abstracts with a didactic lecture by an expert who summarizes the
field and places the abstract in the appropriate context, with a focus on how
the findings apply to clinical practice. Abstracts selected for these
high-profile sessions may cross disease sites or disciplines but are unified in
their focus on a key scientific topic as it relates to the field of cancer
research.
“We are
pleased with our clinical and operational progress over the quarter – the
fundamental value is very strong”, commented Jonathan Lewis, MD, PhD, Chief
Executive Officer of the Company. “In addition, the Company has
impacted cash runway by exceptionally tightly managing expenses and focusing our
clinical development programs.”
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
(ZymafosTM or
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.
Indibulin
(ZybulinTM or
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 completing Phase I trials in combination
with Tarceva® and Xeloda®. Oral indibulin preclinical “dose density”
and “metronomic” dose administration studies with our consultant Dr. Larry
Norton have progressed to the point of translation with the intention of further
pursuit in clinical study.
Darinaparsin
(ZinaparTM or
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, risks related to the
Company's ability to protect its intellectual property and its reliance on third
parties to develop its product candidates, risks related to the sufficiency of
existing capital reserves to fund continued operations for a particular amount
of time and uncertainties regarding the Company’s ability to obtain additional
financing to support its operations thereafter. The Company assumes no
obligation to update these forward-looking statements, except as required by
law.
# # #
Contacts:
Tyler
Cook
ZIOPHARM
Oncology, Inc.
(617)
259-1982
tcook@ziopharm.com
or
Dennis
Dobson
International
Investor Relations Inc.
(203)
258-0159
dsdobson@optonline.net