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 17,
2010
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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(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 March
17, 2010, ZIOPHARM Oncology, Inc. (the “Company”) issued a press release
announcing its financial condition and results of operations for the fourth
quarter and full year ended December 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 March 17,
2010
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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:
March 17, 2010
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Name:
Richard Bagley
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Title:
President, Chief Operating Officer and Chief Financial
Officer
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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 17,
2010
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4
Exhibit
99.1
ZIOPHARM
REPORTS FOURTH QUARTER AND
FULL
YEAR 2009 FINANCIAL RESULTS
NEW YORK, NY – March 17, 2010
- - 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 2009, and the filing of
its Annual Report on Form 10-K with the Securities and Exchange Commission.
Summary financials for the fourth quarter and for the year are
attached.
The
Company reported net income of $1.0 million, or $0.03 per share for the quarter
ended December 31, 2009, compared to a net loss of 4.6 million, or $(0.21) per
share, in the fourth quarter of 2008. Without the recognition of a non-cash gain
of $5.0 million attributable to the change in liability-classified warrants,
there was a net loss of $4.0 million, or $(0.14) per share, for the fourth
quarter ended December 31, 2009. Net loss for the year was $7.6 million, or
$(0.33) per share, compared to $25.2 million, or $(1.19) per share, for the full
year 2008. Total operating expenses for the fourth quarter decreased by $536
thousand compared to the fourth quarter of 2008. The significant decrease in
operating expenses is attributable to a continued focus on resources as well as
tight management of operating expenses. Total operating expense for the year was
$12.1 million, compared to $25.6 million for 2008, or a decrease of $13.5
million. The Company ended the December 2009 quarter with cash of approximately
$48.8 million that, under current assumptions which are subject to change, is
expected to support operations early into the first quarter of
2012.
During
the fourth quarter, the Company completed an underwritten offering of its common
stock and warrants resulting in net proceeds of approximately $45.3 million
after paying offering expenses of approximately $2.8 million.
The
Company’s clinical programs continued to progress in 2009 as permitted by
available financial resources. Our principal focus following recent completion
of financing transactions in both the third and fourth quarters of 2009 remains
the development of intravenous palifosfamide for the treatment of soft tissue
sarcoma (“STS”). A randomized Phase
II multicenter, parallel group, randomized study of palIfosfamide
tris plus doxorubicin versus doxorubiCin
in subjects with unresectAble
or metastatic Soft
tissue SarcOma
(PICASSO) is ongoing in the front- and second-line setting of STS. The Company
reported favorable interim results from the PICASSO trial that were subsequently
presented at the 2009 Connective Tissue Oncology Society’s (“CTOS”) annual
meeting after enrollment in the trial was terminated early at 67
patients. Following U.S. Food and Drug Administration (“FDA”) and
European Medicines Agency (“EMA”) protocol review, the Company expects to
initiate a global registration trial in STS as early as the first half of 2010.
The Company is also in dialogue with FDA related to intravenous Phase II
darinaparsin (ZinaparTM or
ZIO-101) study results in lymphoma, and following an evaluation of various
alternatives in light of our principal focus on palifosfamide development, we
expect to initiate a planned registration and other trials for intravenous
darinaparsin. A Phase I trial for an oral form of darinaparsin is in progress
and early results were reported at ASCO in 2009. With respect to the Company’s
third product candidate, indibulin (ZybulinTM or
ZIO-301), we expect a Phase I portion of a Phase I/II study in breast cancer
involving a “dose dense” administration schedule developed preclinically by our
consultant, Dr. Larry Norton, will initiate in the first half of 2010 at the
Memorial Sloan Kettering Cancer Center.
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 comprises 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 DNA-alkylating drugs used to treat cancers. Palifosfamide does not have the
toxic metabolites of ifosfamide that cause the debilitating side effects of
“fuzzy brain” (encephalopathy) and severe bladder inflammation. It
may also have other advantages. 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 with the Company
having reported interim positive results in late 2009; a registration trial in
the same setting is expected to initiate following U.S. Food and Drug
Administration (FDA) review in the first half of this year. An oral form of
palifosfamide has been developed preclinically to the investigational new drug
application stage.
Darinaparsin
(ZinaparTM or
ZIO-101) is a novel
mitochondrial-targeted agent (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. The Company has
reported favorable results from a Phase II trial with IV-administered
darinaparsin in lymphoma, particularly peripheral T-cell lymphoma (“PTCL”), at
the American Society of Clinical Oncology (ASCO) in May of 2009 which would
serve as the basis for ongoing clinical study in PTCL following regulatory
review and available financial resources Phase I trials with the oral form are
ongoing in both hematological malignancies and solid tumors.
Indibulin
(ZybulinTM or
ZIO-301) is a
novel, oral tubulin binding agent that targets both mitosis and cancer cell
migration. In addition, 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 last 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; employing this dosage schedule, the Company
expects to initiate a Phase I study early this year in breast cancer patients
with the breast team at Memorial Sloan Kettering.
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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 the results of
clinical trials may not support the Company's claims, the risk that pre-clinical
or clinical trials will proceed on schedules that are consistent with the
Company’s current expectations or at all, 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.
3
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ZIOPHARM
Oncology, Inc.
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Condensed
Statements of Operations
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(in
thousands except share and per share data)
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Three
Months Ended
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Year
Ended
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December
31,
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December
31,
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|||||||||||||||
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(unaudited)
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(unaudited)
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2009
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2008
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2009
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2008
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Research
contract revenue
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$ | - | $ | - | $ | - | $ | - | ||||||||
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Operating
expenses:
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Research
and development, including
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costs
of research contracts
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1,216 | 3,026 | 4,556 | 17,245 | ||||||||||||
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General
and administrative
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2,813 | 1,539 | 7,567 | 8,374 | ||||||||||||
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Total
operating expenses
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4,029 | 4,565 | 12,123 | 25,619 | ||||||||||||
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Loss
from operations
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(4,029 | ) | (4,565 | ) | (12,123 | ) | (25,619 | ) | ||||||||
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Other
income (expense), net
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12 | 2 | 13 | 388 | ||||||||||||
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Change
in fair value of warrants
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4,981 | - | 4,461 | - | ||||||||||||
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Net
income (loss)
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$ | 964 | $ | (4,563 | ) | $ | (7,649 | ) | $ | (25,231 | ) | |||||
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Basic
and diluted net income (loss) per share
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$ | 0.03 | $ | (0.21 | ) | $ | (0.33 | ) | $ | (1.19 | ) | |||||
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Weighted
average common shares outstanding used
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to
compute basic net income (loss) per share
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28,002,429 | 21,243,638 | 23,108,039 | 21,232,663 | ||||||||||||
| Weighted average common shares outstanding used | ||||||||||||||||
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to
compute diluted net income (loss) per share
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30,012,082 | 21,243,638 | 23,108,039 | 21,232,663 | ||||||||||||
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ZIOPHARM
Oncology, Inc.
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Balance
Sheet Data
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(in
thousands)
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December
31,
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December
31,
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2009
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2008
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(unaudited)
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(unaudited)
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Cash
and cash equivalents
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48,839 | 11,379 | ||||||
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Working
capital
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46,098 | 5,930 | ||||||
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Total
assets
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49,736 | 12,573 | ||||||
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Total
stockholders' equity
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28,104 | 6,739 | ||||||
Contact:
Tyler
Cook
ZIOPHARM
Oncology, Inc.
617-259-1982
tcook@ziopharm.com
4