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): March 23,
2009
ZIOPHARM
Oncology, Inc.
(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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||
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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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|
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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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Item 2.02
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Results
of Operations and Financial
Condition
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On March
24, 2009, ZIOPHARM Oncology, Inc. (the “Company”) issued a press release
announcing its financial condition and results of operations as of and for the
fiscal year ended December 31, 2008. 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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Item
9.01
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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 March 24,
2009
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2
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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||
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By:
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/s/
Richard Bagley
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Date:
March 24, 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 March 24,
2009
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4
Exhibit
99.1
ZIOPHARM
REPORTS FOURTH QUARTER AND FULL YEAR
2008
FINANCIAL RESULTS
NEW YORK, NY – March 24, 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, announced today its
financial results for the fourth quarter and full year 2008 and the filing of
its Annual Report on Form 10-K.
The
Company reported a net loss of $4.6 million, or $(0.21) per share for the
quarter ended December 31, 2008, compared to a net loss of $7.7 million, or
$(0.36) per share, in the fourth quarter of 2007. Net loss for the year
was $25.2 million, or $(1.19) per share, compared to $26.6 million, or $(1.41)
per share, for the full year 2007. Total operating expenses for the fourth
quarter decreased by $3.5 million compared to the fourth quarter of 2007.
This decrease was attributable to a continuing focus of resources on the
Company’s Phase II randomized controlled trial with palifosfamide and on
operating expense management, including workforce reductions, elimination of
cash bonuses for 2008, freezing of annual salary increases for 2009, and other
preclinical and manufacturing expense reductions. Total operating expense
for the year was $25.6 million, compared to $28.6 million for 2007, or a
decrease of $3.0 million.
Cash used in operations for 2008 was
$3.8 million in the fourth quarter and was $23.5 million for the full year.
ZIOPHARM ended 2008 with approximately $11.4 million in total cash and
short-term investments, compared to $35.0 million at year-end 2007. With
its current cash position, marked development and programmatic
focus, and significantly reduced burn rate, the Company now expects its
cash to support operations well into the second quarter of
2010.
“Last
year was a year marked by considerable financial market uncertainty and
therefore for us, product prioritization and expense management, although still
with the view of establishing a portfolio over the longer term rather than a
single product opportunity”, commented Jonathan Lewis, MD, PhD, Chief Executive
Officer of the Company.
The
Company has advanced intravenous palifosfamide (ZIO-201 or ZymafosTM) into a
randomized Phase II trial comparing the treatment of doxorubicin with
palifosfamide and doxorubicin in the front-and second-line setting of metastatic
or unresectable soft tissue sarcoma and expects that, with favorable data, a
registration trial could be initiated as early as the first half of 2010.
While promising data has been established in both the indibulin (ZIO-301
or ZybulinTM )and
darinaparsin (ZIO-101 or ZinaparTM)
programs, the Company will focus its resources on palifosfamide until
it enters into partnering arrangements or otherwise obtains alternate funding.
Oral indibulin preclinical dose administration studies with Dr. Larry Norton
have progressed to the point of translation with the intention of further
pursuit in clinical study. For intravenous and oral darinaparsin, Phase I/II
studies have evidenced clinical activity, particularly in various forms of
lymphoma. Clinical development with oral administration of palifosfamide
will also await partnering or funding.
The
Company’s Form 10-K, which more fully outlines 2008 results and highlights the
Company’s risk factors, can be accessed at www.ziopharm.com.
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 currently nearing completion in Phase I
trials in combination with Tarceva® and Xeloda®. Preclinical study
continues with both “dose density” and “metronomic” administration.
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 is nearing completion of study 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, its reliance on third
parties to develop its product candidates and its inability to obtain additional
financing or enter into partnering arrangements to support continued development
of the Company’s product candidates. 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)
255-7902
dsdobson@optonline.net