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 5, 2010
(Exact
Name of Registrant as Specified in Charter)
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Delaware
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0-32353
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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:
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Written communications pursuant to Rule 425 under the
Securities Act
(17 CFR 230.425).
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Soliciting material pursuant to Rule 14a-12 under the Exchange
Act
(17 CFR 240.14a-12).
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Pre-commencement communications pursuant to
Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b)).
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Pre-commencement communications pursuant to
Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c)).
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Item
5.02
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Departure
of Directors or Principal Officers; Election of Directors; Appointment of
Principal Officers
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On
April 5, 2010, upon the recommendation of the Company’s Corporate Governance and
Nominating Committee of the Board, the Company increased the size of its Board
of Directors from eight members to nine members and filled the resulting Board
seat by electing Mr. George B. Abercrombie to serve as a director until the
Company’s next annual stockholders’ meeting. Mr. Abercrombie has also been
appointed to serve as a member of the Company’s Corporate Governance and
Nominating Committee and Compensation Committee.
In
conjunction with his election to the Board, and in accordance with the Company’s
existing director compensation practices, on April 5, 2010, the Company made new
director grants to Mr. Abercrombie comprised of 25,000 restricted shares of the
Company’s common stock that are subject to restrictions that will lapse on the
one year anniversary of the grant date, and options to purchase 25,000 shares of
the Company’s common stock that will vest in three equal annual installments
commencing on the one year anniversary of the grant date. The options have an
exercise price equal to the closing price of the Company’s common stock on the
trading day preceding the grant date.
Mr. Abercrombie,
age 55, most recently served as the President and CEO of Hoffmann-La Roche Inc.
and Head of North American Pharmaceutical Operations from 2001 through December
2009. Prior to joining Hoffmann-La Roche Inc. in 2001, Mr. Abercrombie held the
position of Senior Vice President, Commercial Operations at Glaxo Wellcome Inc.
and prior to joining Glaxo, held progressively senior positions at Merck and
Company in Merck’s Human Health Division in the United States. Mr.
Abercrombie currently serves as a member of the Board of Directors of Inspire
Pharmaceuticals, Inc.
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Item
7.01
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Regulation
FD Disclosure
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On April
6, 2010, the Company issued a press release announcing the
election of Mr. Abercrombie to its Board of Directors and the appointment of Dr.
Brennan as Chairman of the Board (see Item 8.01 below). A copy of the
press release is furnished as Exhibit 99.1 to this Current
Report on Form 8-K.
In
accordance with General Instruction B.2 of Form 8-K, the information in this
Report, including Exhibit 99.1, shall not be deemed “filed” for the purposes of
Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise
subject to the liabilities of that section, nor shall it be deemed incorporated
by reference in any filing under the Securities Act of 1933, as amended, except
as shall be expressly set forth by specific reference in such a
filing.
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Item
8.01
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Other
Events
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On March
31, 2010, the Company’s Board of Directors appointed Dr. Murray Brennan, M.D. to
serve as non-executive Chairman of the Board. Dr. Brennan has been a member of
the Company’s Board of Directors since 2005 and prior to his appointment as
Chairman served as Lead Director.
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Financial Statements and
Exhibits
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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 6,
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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By:
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/s/
Richard Bagley
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Date:
April 6, 2010
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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 6,
2010
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4
Exhibit
99.1
ZIOPHARM
Elects George B. Abercrombie, former CEO of
Hoffmann-La
Roche, to Board of Directors
--
Dr. Murray Brennan Named Chairman of Board --
NEW YORK, NY – April 6, 2010 - ZIOPHARM Oncology,
Inc. (Nasdaq: ZIOP), announced today the appointment of George B.
Abercrombie to its Board of Directors. Mr. Abercrombie will serve as
a member of the Board’s Compensation Committee as well as the Nominating and
Corporate Governance Committee. Additionally, Dr. Murray Brennan was
elected Chairman of the Board.
Mr.
Abercrombie most recently served as the President and Chief Executive Officer of
Hoffmann-La Roche (Roche) North America and has more than 30 years experience in
the pharmaceutical industry. He was responsible for Roche’s U.S. and Canadian
Pharmaceuticals Business. Under Mr. Abercrombie’s leadership, the value of
Roche’s U.S. business increased, achieving leading market share positions for
key marketed products. In joining the ZIOPHARM board, George will also have the
opportunity to continue his relationship with Dr. Larry Norton, a consultant
partner to ZIOPHARM, with whom he worked closely at Roche and while Dr. Norton
was the president of ASCO. Prior to joining Hoffmann-La Roche Inc. in
2001, Mr. Abercrombie held the position of Senior Vice President, Commercial
Operations at Glaxo Wellcome Inc. and prior to joining Glaxo, held progressively
senior positions at Merck and Company in Merck’s Human Health Division in the
United States.
During
his distinguished career he has testified as an expert witness on numerous
occasions in front of both Houses of the U.S. Congress. Mr. Abercrombie began
his career as a pharmacist after receiving a bachelor’s degree in pharmacy from
the University of North Carolina and earned his MBA from
Harvard University. He has served on many boards and organizations
throughout his career, including the PhRMA (Pharmaceutical Research and
Manufacturers of America) Board of Directors, the Johns Hopkins School of
Hygiene and the Public Health Advisory, Project Hope Board of Directors, and the
Duke University Fuqua School of Business Health Sector Advisory Board, among
others.
“Given
George’s extensive knowledge and understanding of the development and
commercialization of pharmaceutical products across a wide range of indications,
including those for cancer-related therapies, he will be an invaluable addition
to the ZIOPHARM team,” stated Dr. Murray Brennan, Chairman of the
Board. “ZIOPHARM will no doubt benefit from George’s wisdom and
experience and we are extremely pleased to have him on board at this important
transformational stage of the Company’s growth and development.”
“This is
really an exciting time for ZIOPHARM and me. I am thrilled to be joining this
team of enormously impressive professionals who are developing promising
medicines to treat cancer,” commented Mr. Abercrombie. “I look
forward to contributing to ZIOPHARM’s success as we build value for patients,
shareholders, and the healthcare system.”
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
expects to initiate a Phase I study early this year in breast cancer patients
with the breast team at Memorial Sloan Kettering.
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-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, 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.
Contacts:
Tyler
Cook
ZIOPHARM
Oncology, Inc.
617-259-1982
tcook@ziopharm.com
Media:
Dennis
S. Dobson
(203)
258-0159
dsdobson@optonline.net