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): July 31, 2008
ZIOPHARM
Oncology, Inc.
(Exact
name of registrant as specified in its charter)
|
Delaware
|
0-32353
|
84-1475642
|
|
(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)
(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
July
31, 2008, ZIOPHARM Oncology, Inc. issued a press release announcing its
financial results for the three and six-month periods ended June 30, 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 July 31, 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.
|
|
|
ZIOPHARM
Oncology, Inc.:
|
|
|
|
(Registrant)
|
|
|
|
|
|
By:
|
/s/
Richard E. Bagley
|
|
|
|
Name:
|
Richard
E. Bagley
|
|
|
Title:
|
President,
Chief Operating Officer and Chief
Financial
Officer
|
Exhibit
Index
|
Exhibit No.
|
|
Description
|
|
|
|
|
|
99.1
|
|
Press
Release dated July 31, 2008.
|
Exhibit
99.1
ZIOPHARM
ONCOLOGY REPORTS SECOND QUARTER FINANCIAL RESULTS
NEW
YORK - July 31, 2008 -
ZIOPHARM
Oncology, Inc. (NASDAQ: ZIOP) announced today its financial results for the
three and six-month periods ended June 30, 2008.
The
Company reported a net loss for the second quarter of 2008 of $6.5 million,
or
$(0.31) per share, compared with a net loss for the second quarter of 2007
of
$6.5 million, or $(0.31) per share. Total operating expenses for the quarter
were $6.6 million, compared with $7.2 million for the same quarter in the
prior
year. The decrease was primarily due to a reduction in product manufacturing
for
darinaparsin and palifosfamide, and a successful effort to effectively manage
costs. Cash
used
in operations during the second quarter 2008 was $6.4 million, compared with
$5.8 million used in the second quarter 2007.
The
Company reported a net loss in the six-month period ended June 30, 2008 of
$15.1
million, or $(0.71) per share, compared with a net loss of $11.6 million,
or
$(0.60) per share, in the same period of the prior year. Total operating
expenses for the six months ended June 30, 2008 increased by 22.2% to $15.4
million as compared with total operating expenses of $12.6 million in the
same
period in the prior year. Cash used in operations was $13.8 million for the
first six months of 2008, compared with $10.3 million used in the first half
of
2007. ZIOPHARM ended the six-month period with approximately $21.1 million
in
total cash and cash equivalents. With the current cash position, realignment
of
priorities and a completed workforce adjustment we expect our cash to last
late
into the third quarter of 2009.
Highlights
since the beginning of the second quarter 2008 included:
--
Presentation of positive clinical data of darinaparsin in patients with advanced
hematological malignancies, including leukemias and lymphomas, at the American
Association for Cancer Research (AACR) 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 Hodgkin’s lymphoma (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
--
Granting of Orphan Drug Designation by the United States Food & Drug
Administration (FDA) for palifosfamide (ZIO-201) in the treatment of Soft
Tissue
Sarcoma (STS), a disease with significant unmet medical need beyond locally
effective surgery.
--
Promotion of Robert Morgan, JD, to Senior Vice President, Regulatory Affairs,
Quality, and Clinical Development, and Janice Stevens, RN, to Vice President,
Clinical Operations. The appointment of Jonathan Lewis, MD, PhD, Chief
Executive
Officer of ZIOPHARM to the role of Chief Medical Officer following the
departure
of Brian Schwartz, MD, formerly Chief Medical Officer.
--
Expansion of the Company’s intellectual property estate through the Notice of
Allowance from the U.S. Patent and Trademark Office for patent applications
numbered 11/252,966 and 11/349,043, covering claims for various organic
arsenic
compounds, including purified crystalline darinaparsin (ZIO-101), glycolic
arsenicals, and the oral pharmaceutical composition of an organic arsenic
compound, and their use in the treatment of cancer.
Jonathan
Lewis, MD, PhD Chief Executive and Chief Medical Officer of ZIOPHARM, commented,
"We have made encouraging progress in a number of key areas during the second
quarter, including intellectual property, clinical data and regulatory
achievement. We look forward to reaching additional clinical milestones over
the
balance of the year, while remaining focused on conserving capital and
minimizing expenses during a challenging period for the financial
markets."
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 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-E
#
#
#
Contacts:
Suzanne
McKenna
ZIOPHARM
Oncology, Inc.
(646)
214-0703
smckenna@ziopharm.com
or
Andrea
Rabney
Argot
Partners
(212)
600-1902
andrea@argotpartners.com