Full Press Release Details
REPORTS FOURTH QUARTER AND
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
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
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.
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
(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.
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
expects to initiate a Phase I study early this year in breast cancer patients
with the breast team at Memorial Sloan Kettering.
operations are located in Boston, MA with an executive office in New York
information about ZIOPHARM may be found at www.ziopharm.com.
Safe Harbor Statement:
press release contains forward-looking statements for ZIOPHARM Oncology, Inc.