Current Report — Form 8-K Filing Table of Contents
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1: 8-K Current Report HTML 35K
2: EX-4.1 Instrument Defining the Rights of Security Holders HTML 75K
3: EX-4.2 Instrument Defining the Rights of Security Holders HTML 69K
4: EX-10.1 Material Contract HTML 213K
5: EX-10.2 Material Contract HTML 132K
6: EX-99.1 Miscellaneous Exhibit HTML 19K
ZIOPHARM
Announces At Market Private Placement of $5.05 Million
NEW YORK, NY – September 9,2009 - ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP) announced today that it has
entered into definitive agreements with both existing and new investors to raise
approximately $5.05 million in gross proceeds, before deducting placement agent
fees and estimated offering expenses, in a private placement that was priced “at
market.” Upon closing of the private placement, the Company will
issue units consisting of one share of common stock and a warrant to purchase
one share of common stock, with the purchase price per unit of $1.825. Pursuant
to the agreements governing the private placement, the Company will issue
approximately 2.77 million shares of common stock and warrants to purchase
approximately 2.77 million additional shares of common stock in the
aggregate. The closing of the offering is subject to certain
conditions, and is expected to occur on or around September 15,2009.
Rodman
& Renshaw, LLC, a subsidiary of Rodman & Renshaw Capital Group, Inc.,
(Nasdaq: RODM - News), acted as the exclusive placement agent for the
transaction, with Riverbank Capital Securities, Inc. and Griffin Securities,
Inc. serving as sub-agents.
The
Company intends to use the proceeds from the financing for working capital and
general corporate purposes, including ongoing clinical development of its three
product candidates, palifosfamide (ZymafosTM or
ZIO-201), darinaparsin (ZinaparTM or
ZIO-101), and indibulin (ZybulinTM or
ZIO-301).
The
securities sold in the private placement have not been registered under the
Securities Act of 1933, as amended, and may not be offered or sold in the United
States absent registration under such act and applicable state securities laws
or an applicable exemption from those registration requirements. The Company has
agreed to file a registration statement covering the resale of the shares issued
in the private placement, including the shares issuable upon exercise of the
warrants. This press release shall not constitute an offer to sell or the
solicitation of an offer to buy these securities, nor shall there be any sale of
these securities in any jurisdiction in which such offer, solicitation or sale
would be unlawful prior to the registration or qualification under the
securities laws of any such jurisdiction.
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 is 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 alkylating drugs used to treat certain cancers. Palifosfamide does not have
the toxic metabolites of ifosfamide that cause the debilitating side effects of
“fuzzy brain” (encephalopathy) and severe bladder inflammation. 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, a study
expected to establish the basis for a registration trial as early as the first
half of 2010. An oral form of palifosfamide has been developed
preclinically to the investigational new drug application stage.
Indibulin
(ZybulinTM or
ZIO-301) is a
novel, oral tubulin binding agent that targets both mitosis and cancer cell
migration. 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 this 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. The Company expects to initiate a
Phase I/II study of oral indibulin in breast cancer patients employing this
dosing schedule established preclinically. Once the maximum tolerated dose is
established in the phase I portion of the trial, Phase II will proceed with an
expanded population.
Darinaparsin
(ZinaparTM or
ZIO-101) is a novel
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. Phase
I and Phase II testing of the intravenous form of darinaparsin in solid tumors
and hematological cancers has been completed or is nearing completion. The
Company has reported clinical activity and, importantly, a safety profile from
these studies as predicted by preclinical results. Favorable results from the
trial with IV-administered darinaparsin in lymphoma, particularly peripheral
T-cell lymphoma (“PTCL”), were reported at the American Society of Clinical
Oncology (‘ASCO”) in May. Supported by these data, the Company expects to
advance into a registration trial in peripheral T-cell lymphoma as early as the
first half of 2010. Also as reported at ASCO, in ongoing Phase I trials the oral
form is active and well tolerated.
ZIOPHARM’s
operations are located in Boston, MA with an executive office in New York.
Further information about ZIOPHARM may be found at www.ziopharm.com.
ZIOP-G
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, 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.
