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): July 16, 2012
ZIOPHARM Oncology, Inc.
(Exact Name of Registrant as Specified in Charter)
| Delaware | 001-33038 | 84-1475672 | ||
|
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
| 1180 Avenue of the Americas 20th Floor New York, NY |
10036 | |
| (Address of Principal Executive Offices) | (Zip Code) |
(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:
| o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425). |
| o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12). |
| o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)). |
| o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)). |
| Item 5.02 | Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. |
On July 16, 2012, ZIOPHARM Oncology, Inc., or the Company, announced the adoption of a new, streamlined executive leadership team reporting to Jonathan Lewis, MD, PhD, the Company’s Chief Executive Officer. As part of the streamlined reporting structure, the Company exercised its right to terminate without cause each of Richard E. Bagley as President and Chief Operating Officer, and Mark Thornton, MD, PhD as Executive Vice President, Government Affairs, Health Policy and Advocacy and Chief Quality Compliance Officer, effective immediately pursuant to their respective employment agreements. Mr. Bagley is also stepping down from the Company’s board of directors, effective immediately.
Under the terms of Mr. Bagley’s equity awards at the time of his termination, all of his shares of restricted stock and options that were not vested as of the date of his termination would be forfeited, and he would have 90 days from the date of termination in which to exercise his vested options. However, in connection with Mr. Bagley’s termination, on July 16, 2012, the compensation committee of the Company’s board of directors and the stock plan subcommittee of the compensation committee approved certain amendments to the agreements governing his outstanding equity awards, subject to Mr. Bagley’s entry into a separation and release agreement and consulting agreement for a term of six months with the Company. Mr. Bagley entered into such separation and release agreement and six month consulting agreement following his termination on July 16, 2012. Accordingly, the amendments to the agreements governing Mr. Bagley’s outstanding equity awards took effect, namely: (i) the post-employment period within which Mr. Bagley may exercise his vested options will be extended for a period of up to eighteen months following his termination date; (ii) all unvested shares of restricted stock and unvested options will continue to vest in accordance with their existing schedules subject to Mr. Bagley’s continued provision of consulting services to the Company and his full compliance with the separation and release agreement and any other agreements entered into between Mr. Bagley and the Company and (iii) all unvested shares of restricted stock and unvested options will vest in full on the earliest of (a) the expiration of the six month term of the consulting agreement; (b) the date that the Company terminates the consulting agreement without cause and (c) Mr. Bagley’s death; provided, that if the consulting agreement is terminated for any reason other than by the Company without cause or Mr. Bagley’s death, then Mr. Bagley will forfeit any unvested shares of restricted stock and unvested options then held by him.
On July 16, 2012, the Company issued a press release announcing the new executive leadership team and the departure of Mr. Bagley and Dr. Thornton. The press release is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits |
| (d) | Exhibits. |
| Exhibit No. | Description |
| 99.1 | Press release dated July 16, 2012. |
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.
| ZIOPHARM Oncology, Inc. | ||
| By: | /s/ Caesar Belbel | |
| Date: July 17, 2012 | Name: Caesar Belbel | |
| Title: Executive Vice President, Chief Legal Officer and Secretary | ||
INDEX OF EXHIBITS
| Exhibit No. | Description |
| 99.1 | Press release dated July 16, 2012. |
Exhibit 99.1
ZIOPHARM Oncology Announces New Executive
Team
NEW YORK, NY – July 16, 2012 – ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced a new executive leadership team reporting to Jonathan Lewis, M.D., Ph.D., Chief Executive Officer. Under this new structure, Hagop Youssoufian, M.Sc., M.D., President of Research and Development and Chief Medical Officer, will, in addition to his current responsibilities, assume oversight of all regulatory affairs and clinical operations, and Caesar J. Belbel, Executive Vice President, Chief Legal Officer and Secretary, will add responsibility for corporate and business development. Jason A. Amello, Executive Vice President and Chief Financial Officer, will continue to be responsible for finance and information technology, and Lynn M. Ferrucci, Senior Vice President, Human Resources, will continue to oversee human resources.
In conjunction with the introduction of the new reporting structure, Richard E. Bagley, President, Chief Operating Officer and Director, is leaving the Company and stepping down from the Company’s Board of Directors. Additionally, Mark Thornton, M.D., Ph.D., Executive Vice President, Government Affairs, Health Policy and Advocacy and Chief Quality Compliance Officer, is leaving the Company to pursue other opportunities. Both Mr. Bagley and Dr. Thornton are expected to remain available to ZIOPHARM on an advisory basis. With Dr. Thornton’s departure, ZIOPHARM will no longer maintain an office in Germantown, MD.
“The management team has been greatly strengthened over the past year with the addition of Hagop, Caesar, Jason, and Lynn,” said Dr. Lewis. “Finalization of the executive reporting structure completes the build-out of this expert leadership team, whose experience and record of recent successes in the biopharma industry align perfectly with our current and future strategic path. This streamlined team is now well positioned to guide ZIOPHARM through a critical period, as we look to near-term data from the pivotal PICASSO3 trial of palifosfamide in soft tissue sarcoma, growing momentum in the MATISSE study of palifosfamide in small cell lung cancer, and advancement of our DNA therapeutics program and platform.”
Dr. Lewis emphasized: “We thank Dick and Mark for their service to the Company. As part of the management team that has driven ZIOPHARM to this pivotal stage, each has made important contributions to our success.”
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), a novel DNA-targeted cancer treatment that bypasses drug resistance mediated by ALDH (aldehyde dehydrogenase), an enzyme associated with cancer stem cells, and has a favorable toxicity profile. Intravenous palifosfamide is currently being studied in a randomized, double-blinded, placebo-controlled Phase 3 trial (PICASSO 3) for the treatment of front-line metastatic soft tissue sarcoma and is also in a pivotal Phase 3 trial (MATISSE) for front-line metastatic small cell lung cancer. Additionally, the Company is developing an oral capsule form of palifosfamide.
IL-12 DNA, a novel DNA therapeutic that is delivered to the patient’s tumor and expresses interleukin-12, a protein that controls anti-cancer immune responses. IL-12 DNA is currently in two Phase 1 studies, with plans to move into Phase 2 studies. ZIOPHARM’s DNA therapeutics are being developed in partnership with Intrexon Corporation through a revolutionary synthetic biology platform that allows for targeted, controlled production of therapies in humans with a biologic on/off switch (the RheoSwitch Therapeutic System®). Preclinical and discovery work with multiple therapeutic approaches, such as antibodies, immunotoxins, and protein decoys, is expected to result in multiple clinical candidates in the next 12 to 24 months.
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, 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, Darinaparsin, Indibulin, and our other therapeutic products will be successfully marketed if approved; whether our DNA-based biotherapeutics 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 DNA-based biotherapeutics; 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, 2011, and our Quarterly Report on Form 10-Q for the fiscal quarter ended March 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.
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