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): August 14, 2009
(Exact
Name of Registrant as Specified in Charter)
|
Delaware
|
0-32353
|
84-1475672
|
||
|
(State
or Other Jurisdiction
of
Incorporation)
|
(Commission
File Number)
|
(IRS
Employer
Identification
No.)
|
|
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)
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:
|
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)).
|
On August
14, 2009, ZIOPHARM Oncology, Inc. (the “Company”) issued a press release
announcing its financial condition and results of operations for the second
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.
|
(d)
|
Exhibits
|
|
Exhibit
No.
|
Description
|
|
|
99.1
|
Press
Release of the Company dated August 14,
2009
|
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.
|
ZIOPHARM
Oncology, Inc.
|
||
|
By:
|
/s/
Richard Bagley
|
|
|
Date:
August 14, 2009
|
Name:
Richard Bagley
|
|
|
Title:
President, Chief Operating Officer and Chief Financial
Officer
|
||
3
INDEX OF
EXHIBITS
|
Exhibit
No.
|
Description
|
|
|
99.1
|
Press
Release of the Company dated August 14,
2009
|
4
Exhibit
99.1
ZIOPHARM
REPORTS SECOND QUARTER FINANCIAL RESULTS
AND
UPDATES CLINICAL PROGRAMS
NEW YORK, NY – August 14, 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 June 30, 2009 and provided an update on
the Company’s clinical programs following the Company’s presentations at the
2009 American Society of Clinical Oncology (ASCO) Annual Meeting.
The
Company reported a net loss for the second quarter 2009 of $2.4 million, or
$(0.11) per share, compared with a net loss for the second quarter of 2008 of
$6.5 million, or $(0.31) 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 second quarter of 2009, as compared to
2008, Research and Development expenses declined $3.8 million while General and
Administrative expenses declined by $0.7 million. Net cash used in operations
was $2.2 million in the second quarter of 2009 as compared with $6.4 million
during the comparable 2008 period. The decrease in net cash used in operations
was primarily attributable to a decrease in net loss from operations of $4.4
million. The Company ended the June 2009 quarter with cash of approximately $4.5
million which is expected to support operations into the second quarter of
2010.
With
regard to the Company’s clinical programs, enrollment in the palifosfamide
(ZymafosTM or
ZIO-201) Phase II trial in metastatic or unresectable soft tissue sarcoma, the
principal focus of current resources, continues in a robust manner. The
objective of the Phase II trial is to generate data in a randomized controlled
setting that would serve as a basis for conferencing with the U.S. Food and Drug
Administration (FDA) on the design of a registration trial, a study the Company
expects could initiate as early as the first half of 2010. With the availability
of additional resources, the Company will also plan to review the intravenous
Phase II darinaparsin (ZinaparTM or
ZIO-101) study results in lymphoma with the FDA with the intent of conducting a
registration trial in T-cell lymphoma, also as early as the first half of 2010;
and the oral darinaparsin Phase I trials would be continued to maximum tolerated
dose with a focus on lymphoma. Similarly, 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 in collaboration with
Dr. Larry Norton and initiating in 2009 with the teams of Dr. Clifford Hudis in
the United States and Dr. Jose Baselga 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.
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.
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.
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