ZIOPHARM Reports Fourth Quarter and Full Year 2012 Financial Results

ZIOPHARM Reports Fourth Quarter and Full Year 2012 Financial Results

Company to Announce Topline Results From Phase 3 Trial of Palifosfamide in
Soft Tissue Sarcoma (PICASSO 3) Last Week of March

NEW YORK, March 18, 2013 (GLOBE NEWSWIRE) -- ZIOPHARM Oncology, Inc.
(Nasdaq:ZIOP) announced today its financial results for the fourth quarter and
full year ending December 31, 2012, and the filing of its Annual Report on
Form 10-K with the Securities and Exchange Commission.

Fourth Quarter Results

The Company reported a GAAP net loss of $30.2 million for the fourth quarter
of 2012, or $(0.37) per share, compared to a GAAP net loss of $13.2 million,
or $(0.19) per share, in the fourth quarter of 2011. Excluding non-cash income
of $8.6 million attributable to the change in liability-classified warrants,
Non-GAAP^1 net loss was $38.8 million, or $(0.48) per share, for the fourth
quarter ended December 31, 2012. In comparison, Non-GAAP^1 net loss for the
fourth quarter of 2011 was $16.4 million, or $(0.24) per share, which excludes
non-cash income of $3.2 million attributable to the change in
liability-classified warrants.

Operating expenses for the fourth quarter of 2012 were $39.0 million, compared
to $16.6 million for the fourth quarter of 2011. The $22.4 million increase is
primarily attributable to the $18.7 million fourth quarter 2012 non-cash
expense associated with the issuance of approximately 3.6 million shares of
common stock to Intrexon Corporation upon the achievement of the contractual
milestone associated with dosing of the first patient in the Ad-RTS IL-12
Phase 2 trial. Other costs related to the expansion of our synthetic biology
therapeutics program contributed to the remainder of the increase during the
period.

Full Year Results

The Company reported a GAAP net loss of $96.1 million for the year ended
December 31, 2012, or $(1.22) per share, compared to a GAAP net loss of $63.8
million, or $(0.97) per share, for the year ended December 31, 2011.
Excluding non-cash income of $6.1 million attributable to the change in
liability-classified warrants, Non-GAAP^1 net loss was $102.2 million, or
$(1.30) per share, for the year ended December 31, 2012. In comparison,
Non-GAAP^1 net loss for 2011 was $71.4 million, or $(1.08) per share, which
excludes non-cash income of $7.6 million attributable to the change in
liability-classified warrants.

Operating expenses for the year ended December 31, 2012 were $103.0 million,
compared to $72.1 million for the year ended December 31, 2011. The $30.9
million increase is attributable to start-up and ongoing enrollment activities
for the pivotal Phase 3 trial (MATISSE) of palifosfamide in metastatic small
cell lung cancer (SCLC), which was initiated in the second quarter, as well as
expanded development, manufacturing, nonclinical and clinical activities in
support of the Company's palifosfamide and synthetic biology therapeutics
programs.

The Company ended the year with $73.3 million in cash and cash equivalents,
which is currently expected to support operations into the second half of
2013.

Progress and Milestones within Lead Programs

Palifosfamide (Zymafos^® or ZIO-201):

  ZIOPHARM's palifosfamide program has made significant progress, including in
  its two pivotal Phase 3 studies and the initiation of a Phase 2 study.

  The Company announced in February 2013 that the Phase 3 trial of
  palifosfamide in first-line metastatic soft tissue sarcoma (PICASSO 3)
  reached its target number of progression-free survival (PFS) events.
  PICASSO 3 is an international, randomized, double-blind, placebo-controlled
  trial with a primary endpoint of PFS and a secondary endpoint of overall
  survival (OS). The trial is powered for both PFS and OS, with PFS
  determined by independent, blinded radiologic review.The Company expects to
  announce results from this trial, including topline PFS data and an interim
  OS futility analysis, during the last week of March 2013. The trial is
  expected to remain blinded for OS.The study is also being submitted as a
  late-breaking abstract for the annual meeting of the American Society of
  Clinical Oncology (ASCO).

  In June 2012, ZIOPHARM announced the initiation of an international,
  multi-center, open-label, adaptive, randomized, pivotal Phase 3 trial
  (MATISSE) of palifosfamide in combination with carboplatin and etoposide
  (PaCE) chemotherapy compared to carboplatin and etoposide alone in up to 548
  chemotherapy naïve patients with metastatic small cell lung cancer.After 20
  patients received at least two chemotherapy cycles, the study's Independent
  Data Monitoring Committee conducted an analysis of safety data and
  recommended that the trial proceed as planned.Enrollment is ongoing and
  remains ahead of projections.

  ZIOPHARM also recently announced the initiation of a multicenter, single arm
  Phase 2 investigator-sponsored study of palifosfamide in patients with
  recurrent metastatic germ cell (testicular and ovarian) tumors who have
  relapsed on initial platinum-based therapy and high dose chemotherapy, or
  patients who are not eligible for high dose chemotherapy. The study is
  being led by Lawrence Einhorn, M.D., Distinguished Professor of the
  Department of Medicine, Division of Hematology/Oncology at the Indiana
  University School of Medicine, who is also the lead investigator for the
  MATISSE trial.

Synthetic Biology:

  ZIOPHARM continues to make significant strides with its synthetic biology
  platform.The Company recently initiated a randomized, open label study of
  Ad-RTS IL-12, ZIOPHARM's lead, DNA-based therapeutic for the expression of
  interleukin-12 (IL-12), a protein important for an immune response to
  cancer, in combination with palifosfamide in patients with non-resectable
  recurrent or metastatic breast cancer.This study is based on recent
  research positively correlating survival with an immune response in breast
  cancers targeted with non-immune treatments, together with preclinical data
  demonstrating powerful synergy.

  In October 2012, ZIOPHARM initiated a Phase 2 multi-center, single-arm,
  open-label expansion study that will enroll up to 15 patients with
  unresectable Stage III or IV melanoma. This study will further evaluate the
  safety and efficacy of intratumoral injections of Ad-RTS IL-12. Data from
  this study are expected in the second half of 2013.The study follows
  completion of a successful, dose-escalation Phase 1 study in which clinical
  activity was observed in 5 of 7 (71%) patients dosed at the two highest dose
  levels.

  In November 2012, the Company announced results from a preclinical study
  demonstrating the long-term persistence and anti-tumor effects of a new
  synthetic biology approach (DNA/cell plasmid) to controlled protein
  production in vivo. This embedded controlled bioreactor study was presented
  at the EORTC-NCI-AACR International Conference on Molecular Targets and
  Cancer Therapeutics. The Company also presented preclinical data at the
  American Association for Cancer Research (AACR) Annual Meeting in
  March/April 2012, demonstrating the significant anti-tumor activity of
  Interleukin-12 (IL-12) and interferon alpha (IFNα), two proteins involved in
  immune response to cancers, expressed in vivo utilizing a regulated gene
  system. The presentation was recognized as among the best science by the
  AACR Program Committee, a designation awarded to the top 2.5 percent of
  abstracts.

About ZIOPHARM Oncology, Inc.:

ZIOPHARM Oncology is a biopharmaceutical company focused on the development
and commercialization of new cancer therapies. The Company's clinical
programs include:

Palifosfamide (ZIO-201) is a potent bi-functional DNA alkylating agent that
has activity in multiple tumors by evading typical resistance pathways.
Palifosfamide is in the same class as bendamustine, cyclophosphamide, and
ifosfamide. Intravenous palifosfamide is currently being studied in a
randomized, double-blinded, placebo-controlled Phase 3 trial (PICASSO 3) for
the treatment of first-line metastatic soft tissue sarcoma and is also in a
pivotal Phase 3 trial (MATISSE) for first-line metastatic small cell lung
cancer. Additionally, the Company is developing an oral capsule form of
palifosfamide.

Ad-RTS IL-12 is currently being tested in two Phase 2 studies, the first for
the treatment of advanced melanoma, and the second in combination with
palifosfamide for the treatment of non-resectable recurrent or metastatic
breast cancer.Ad-RTS IL-12 uses synthetic biology to enable controlled, local
delivery of therapeutic interleukin-12 (IL-12), a protein important for an
immune response to cancer. ZIOPHARM's DNA synthetic biology platform is being
developed in partnership with Intrexon Corporation and employs an inducible
gene-delivery system that enables controlled, local delivery of genes that
produce therapeutic proteins to treat cancer. This is achieved by placing
IL-12 under the control of Intrexon's proprietary biological "switch" (the
RheoSwitch Therapeutic System^®, RTS^®) to turn on/off the therapeutic protein
expression at the tumor site.

Indibulin (ZIO-301) is a novel, tubulin binding agent that is expected to have
several potential benefits, including oral dosing, application in multi-drug
resistant tumors, no neuropathy and a tolerable toxicity profile. It is
currently being studied in a Phase 1/2 trial in metastatic breast cancer.

Darinaparsin (ZIO-101) is a novel mitochondrial-and hedgehog-targeted agent
(organic arsenic) currently in ongoing studies with Solasia Pharma K.K.

ZIOPHARM's operations are located in Boston, MA, and New York City. Further
information about ZIOPHARM may be found at www.ziopharm.com.

Forward-Looking Safe Harbor Statement:

This press release contains certain forward-looking information about ZIOPHARM
Oncology that is intended to be covered by the safe harbor for
"forward-looking statements" provided by the Private Securities Litigation
Reform Act of 1995, as amended. Forward-looking statements are statements that
are not historical facts. Words such as "expect(s)," "feel(s)," "believe(s),"
"will," "may," "anticipate(s)" and similar expressions are intended to
identify forward-looking statements. These statements include, but are not
limited to, statements regarding our ability to successfully develop and
commercialize our therapeutic products; our ability to expand our long-term
business opportunities; financial projections and estimates and their
underlying assumptions; and future performance. All of such statements are
subject to certain risks and uncertainties, many of which are difficult to
predict and generally beyond the control of the Company, that could cause
actual results to differ materially from those expressed in, or implied or
projected by, the forward-looking information and statements. These risks and
uncertainties include, but are not limited to: whether Palifosfamide, Ad-RTS
IL-12, Darinaparsin, Indibulin, or any of our other therapeutic products will
advance further in the clinical trials process and whether and when, if at
all, they will receive final approval from the U.S. Food and Drug
Administration or equivalent foreign regulatory agencies and for which
indications; whether Palifosfamide, Ad-RTS IL-12, Darinaparsin, Indibulin, and
our other therapeutic products will be successfully marketed if approved;
whether any of our other therapeutic product discovery and development efforts
will be successful; our ability to achieve the results contemplated by our
collaboration agreements; the strength and enforceability of our intellectual
property rights; competition from pharmaceutical and biotechnology companies;
the development of and our ability to take advantage of the market for our
therapeutic products; our ability to raise additional capital to fund our
operations on terms acceptable to us; general economic conditions; and the
other risk factors contained in our periodic and interim SEC reports filed
from time to time with the Securities and Exchange Commission, including but
not limited to our Annual Report on Form 10-K for the fiscal year ended
December 31, 2012.Readers are cautioned not to place undue reliance on these
forward-looking statements that speak only as of the date hereof, and we do
not undertake any obligation to revise and disseminate forward-looking
statements to reflect events or circumstances after the date hereof, or to
reflect the occurrence of or non-occurrence of any events.

___________________________

^1 Non-GAAP net loss is calculated as GAAP net loss less the expense (or plus
the income) associated with the change in fair value of the
liability-classified warrants.Non-GAAP net loss per share is calculated by
dividing the Non-GAAP net loss by the weighted average common shares
outstanding.

ZIOPHARM Oncology, Inc.
Condensed Statements of Operations
(in thousands except share and per share data)
(unaudited)
                                                               
                              Three Months Ended      Twelve Months Ended
                               December 31,            December 31,
                              2012        2011        2012        2011
                                                               
Revenue                        $200      $200      $800      $667
                                                               
Operating expenses:                                             
Research and development       34,982     12,650     83,446     57,083
General and administrative     4,061      3,967      19,523     14,984
Total operating expenses       39,043     16,617     102,969    72,067
                                                               
Loss from operations           (38,843)   (16,417)   (102,169)  (71,400)
                                                               
Other income (expense), net    52         13         (13)       39
Change in fair value of        8,566      3,160      6,050      7,583
warrants
Net loss                       $(30,225) $(13,244) $(96,132) $(63,778)
                                                               
                                                               
Basic and diluted net loss per $(0.37)   $(0.19)   $(1.22)   $(0.97)
share
                                                               
Weighted average common shares
outstanding used to compute    81,347,231 68,160,207 78,546,112 66,003,789
basic and diluted net loss per
share



ZIOPHARM Oncology, Inc.
Balance Sheet Data
(in thousands)
(unaudited)
                                       
                           December 31, December 31,
                            2012         2011
                                       
Cash and cash equivalents   73,306      104,713
Working capital             61,412      92,742
Total assets                83,404      108,108
Total stockholders' equity 48,445      71,607

CONTACT: For ZIOPHARM
         Nicole Jones
         ZIOPHARM Oncology, Inc.
         617-778-2266
         njones@ziopharm.com
        
         Media Contacts:
         David Schull or Lena Evans
         Russo Partners, LLC
         858-717-2310
         212-845-4262
         david.schull@russopartnersllc.com
         lena.evans@russopartnersllc.com

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