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 11,
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
November 11, 2009, ZIOPHARM Oncology, Inc. (the “Company”) issued a press
release announcing its financial condition and results of operations for the
third quarter of 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 November 11,
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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By:
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/s/
Richard Bagley
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Date:
November 11, 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 November 11,
2009
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4
Exhibit
99.1
ZIOPHARM
REPORTS THIRD QUARTER FINANCIAL RESULTS
AND
UPDATED CLINICAL PROGRESS
NEW YORK, NY – November 11,
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 quarter ended September 30, 2009 and
provided an update on the Company’s clinical programs.
The
Company reported a net loss for the third quarter 2009 of $2.9 million, or
$(0.13) per share, compared with a net loss for the third quarter of 2008 of
$5.5 million, or $(0.26) per share. The significant decrease in operating
expenses is attributable to a continuing focus of resources as well as tight
management of operating expenses. For the third quarter of 2009, as compared to
2008, Research and Development expenses declined $2.6 million while General and
Administrative expenses declined by $0.4 million. Net cash used in operations
was $2.1 million in the third quarter of 2009 as compared with $5.9 million
during the comparable 2008 period. The decrease in net cash used in operations
was primarily attributable to a decrease in net loss of $2.7
million. Net cash used in operations for the nine months ended September 30,
2009 and 2008 was $8.9 million and $19.7 million,
respectively. Again, the decrease in net cash used in operations was
primarily attributable to a decrease in the net loss of $12.0
million. The Company ended the September 2009 quarter with cash of
approximately $7.1 million which is expected to support operations into the
second quarter of 2010.
During
the third quarter, the company completed an offering of its common stock and
warrants resulting in net proceeds of approximately $4.6 million after paying
offering expenses of $0.5 million.
The
Company’s clinical programs have progressed well. The palifosfamide
(ZymafosTM,
ZIO-201) randomized Phase II trial in metastatic or unresectable soft tissue
sarcoma achieved the study-specified efficacy milestone following planned
safety and efficacy review by the Data Committee, a panel of international
sarcoma experts, and the Company’s Medical Advisory Board. It was determined
that the data are compelling and sufficient to proceed to a pivotal study in
support of product registration and to conclude enrollment. The Company is in
dialogue with the U.S. Food and Drug Administration (FDA) on the design and
implementation of a registration trial, a study the Company expects could
initiate as early as the first half of 2010. The Company is also in dialogue
with FDA on the intravenous Phase II darinaparsin (ZinaparTM or
ZIO-101) study results in lymphoma with the intent of conducting a registration
trial in peripheral T-cell lymphoma, also as early as the first half of 2010.
The oral darinaparsin Phase I trials continue enrollment in order to establish
the best dose and schedule. Oral indibulin (ZybulinTM or
ZIO-301) is scheduled to enter into a Phase I/II study in breast cancer patients
using the Norton-dosing schedule developed preclinically with Dr. Larry Norton
and initiating in early 2010 with the teams of Dr. Clifford Hudis
(Memorial Sloan-Kettering Cancer Center) in the United States and Dr. Jose
Baselga (Vall d'Hebron University Hospital) in Spain.
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) references a novel composition (tris formulation) that is the
functional active metabolite of ifosfamide, a standard of care for treating
sarcoma, lymphoma, testicular, and other cancers. Palifosfamide delivers
only the cancer fighting component of ifosfamide. It is expected to overcome the
resistance seen with ifosfamide and cyclophosphamide, two of the most commonly
used alkylating drugs used to treat certain cancers. Palifosfamide does not have
the toxic metabolites of ifosfamide that cause the debilitating side effects of
“fuzzy brain” (encephalopathy) and severe bladder inflammation. Intravenous
palifosfamide is currently in a randomized Phase II trial to treat unresectable
or metastatic soft tissue sarcoma in the front- and second-line setting, a study
expected to establish the basis for a registration trial as early as the first
half of 2010. An oral form of palifosfamide has been developed
preclinically to the investigational new drug application stage.
Darinaparsin
(ZinaparTM or
ZIO-101) is a novel
organic arsenic being developed for the treatment of various hematologic and
solid cancers. Preclinical and clinical studies to date have demonstrated that
darinaparsin is considerably less toxic than inorganic arsenic, particularly
with regard to cardiac toxicity. Phase I and Phase II testing of the intravenous
form of darinaparsin in solid tumors and hematological cancers has been
completed or is nearing completion. The Company has reported clinical activity
and, importantly, a safety profile from these studies as predicted by
preclinical results. Favorable results from the trial with IV-administered
darinaparsin in lymphoma, particularly peripheral T-cell lymphoma (“PTCL”), were
reported at the American Society of Clinical Oncology (ASCO) in May. Supported
by these data, the Company expects to advance into a registration trial in
peripheral T-cell lymphoma as early as the first half of 2010. Also as reported
at ASCO, in ongoing Phase I trials the oral form is active and well
tolerated.
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.
In multiple Phase I trials in cancer patients, oral indibulin has been
administered both as a single agent and in combination with favorable activity
and a promising safety profile that does not include the neurotoxicity seen with
all of the other classes of tubulin binding agents. Most recently, results of
oral indibulin in combination with oral capecitabine (Xeloda®) were
presented at this year’s American Society of Clinical Oncology (ASCO) along with
the preclinical findings of a novel dosing schedule conducted under the
direction of Dr. Larry Norton. The Company expects to initiate a Phase I/II
study of oral indibulin in breast cancer patients employing this dosing schedule
established preclinically. Once the maximum tolerated dose is established in the
Phase I portion of the trial, Phase II will proceed with an expanded
population.
ZIOPHARM’s
operations are located in Boston, MA with an executive office in New York
City. 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 final trial data may
not support interim analysis and that the results of clinical trials in general
may not support the Company's claims, risks related to the Company's ability to
protect its intellectual property, risks related to 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.
# # #
Susan
Noonan
S.A.
Noonan Communications, LLC
(212)
966-3650
susan@sanoonan.com
Eric
Goldman - Media
Rx
Communications Group
917-322-2563
egoldman@rxir.com