Full Press Release Details
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.
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
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.
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.
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
during the first quarter, the Company initiated a Phase I/II study of indibulin
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
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
ZIOPHARM Oncology, Inc.:
biopharmaceutical company engaged in the development and commercialization of a
diverse portfolio of cancer drugs. The Company is currently focused on three
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
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.
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.
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.
Safe Harbor Statement:
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