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): April 30, 2010
(Exact
Name of Registrant as Specified in Charter)
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Delaware
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001-33038
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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:
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 April
30, 2010, ZIOPHARM Oncology, Inc. (the “Company”) issued a press release
announcing its financial condition and results of operations for the first
quarter of 2010. 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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(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 April 30,
2010
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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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Date:
April 30, 2010
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By:
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/s/ Richard Bagley | |
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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 April 30,
2010
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4
Exhibit
99.1
ZIOPHARM
REPORTS FIRST QUARTER FINANCIAL RESULTS
--
Decreased Cash Burn from Operations, Continued Clinical Progress --
NEW YORK, NY – April 30, 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, today reported its
financial results for the three months ended March 31, 2010 and updated the
Company’s continued progress with its clinical programs.
In the
first quarter of 2010, the Company’s cash burn from operations was $3.8 million,
a decrease of $0.8 million from $4.6 million for the same period for
2009. The spending decrease represents a continued focus of resources
as well as tight management of operating expenses. The Company ended the March
2010 quarter with cash of approximately $45.0 million. The Company
expects its existing cash resources to support operations early into the first
quarter of 2012, although this expectation could change based on, among other
things, the scope and timing for the Company’s registration trial for
palifosfamide.
The net
loss from operations for the first quarter of 2010 was $4.6 million, or $(0.11)
per share, compared with a net loss from operations for the first quarter of
2009 of $3.3 million, or $(0.16) per share. In the first quarter of
2010, there was a $13.1 million non-cash charge for the change in the fair value
of warrants arising from the increase in the Company’s stock price, resulting in
a total net loss for the first quarter of $17.7 million, or $(0.44) per share,
compared with a net loss for the first quarter of 2009 of $3.3 million, or
$(0.16) per share. The warrant charge relates to fair value
accounting which requires the warrants to be marked to market under accounting
principles generally accepted in the United States.
Research
and development expenses in the first quarter of 2010 increased $0.3 million
while General and administrative expenses increased by $0.9 million. The
increased general and administrative activity during the first three months of
2010 was related to administrative support in preparation for new clinical
studies not yet initiated.
Progress
for all three of the Company’s clinical-stage compounds continue to advance.
Palifosfamide (ZymafosTM or
ZIO-201) has been recognized with acceptance for presentation at the American
Society for Clinical Oncology (ASCO) Annual Meeting in June. It has also been
selected to be included in the 2010 Best of ASCO®. The
Best of ASCO® program
features selected important abstracts that highlight the latest scientific
findings and practice-changing advances in cancer prevention and treatment,
allowing faculty members to provide a clinical context for this new scientific
information. Meetings are conducted in both Boston and San Francisco as well as
in many international cities. The Company expects to initiate a worldwide
palifosfamide Phase III registration trial as early as the first half of this
year.
Also
during the first quarter, the Company initiated a Phase I/II study of indibulin
(ZybulinTM or
ZIO-301) at Memorial Sloan-Kettering Cancer Center for the novel, mathematically
- - determined administration of indibulin in the treatment of metastatic breast
cancer. With regard to darinaparsin (ZinaparTM, or
ZIO-101), the Company recently presented preclinical
data at the
2010 AACR Annual Meeting and the Phase I clinical studies of the oral form of
the drug are continuing while the Company moves to a potential pathway for
regulatory approval of the intravenous form in peripheral T-cell
lymphoma.
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 has
initiated a Phase I study in breast cancer patients with the Breast Cancer
Medicine Service at Memorial Sloan-Kettering Cancer Center.
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.
ZIOPHARM
Oncology, Inc.
Condensed
Statements of Operations
(in
thousands except share and per share data)
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Three
Months Ended
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March
31,
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(unaudited)
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2010
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2009
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|||||||
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Research
contract revenue
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$ | - | $ | - | ||||
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Operating
expenses:
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||||||||
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Research
and development, including
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costs
of research contracts
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1,939 | 1,608 | ||||||
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General
and administrative
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2,630 | 1,724 | ||||||
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Total
operating expenses
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4,569 | 3,332 | ||||||
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Loss
from operations
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(4,569 | ) | (3,332 | ) | ||||
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Other
income (expense), net
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9 | - | ||||||
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Change
in fair value of warrants
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(13,093 | ) | (7 | ) | ||||
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Net
income (loss)
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$ | (17,653 | ) | $ | (3,339 | ) | ||
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Basic
and diluted net income (loss) per share
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$ | (0.44 | ) | $ | (0.16 | ) | ||
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Weighted
average common shares outstanding used
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||||||||
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to
compute basic and diluted net income (loss) per share
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40,150,100 | 21,304,334 | ||||||
ZIOPHARM
Oncology, Inc.
Balance
Sheet Data
(in
thousands)
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March
31,
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December
31,
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|||||||
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2010
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2009
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|||||||
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(unaudited)
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(unaudited)
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Cash
and cash equivalents
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45,044 | 48,839 | ||||||
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Working
capital
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42,523 | 46,098 | ||||||
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Total
assets
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45,840 | 49,736 | ||||||
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Total
stockholders' equity
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11,386 | 28,104 | ||||||
Contacts:
Tyler
Cook
ZIOPHARM
Oncology, Inc.
617-259-1982
tcook@ziopharm.com
Media:
Dennis
S. Dobson
(203)
258-0159
dsdobson@optonline.net