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): March 30, 2015
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.) |
| One First Avenue, Parris Building 34, Navy Yard Plaza Boston, Massachusetts |
02129 | |
| (Address of Principal Executive Offices) | (Zip Code) |
(617) 259-1970
(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:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425). |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12). |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)). |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)). |
| Item 7.01 | Regulation FD Disclosure |
On March 30, 2015, ZIOPHARM Oncology, Inc., or the Company, together with Intrexon Corporation, issued a press release announcing a collaboration with Merck Serono, a copy of which is furnished as Exhibit 99.1 hereto.
This information, including the information contained in the press release furnished as Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not incorporated by reference into any of the Company’s filings, whether made before or after the date hereof, regardless of any general incorporation language in any such filing.
| Item 9.01 | Financial Statements and Exhibits |
| (d) | Exhibits |
| Exhibit No. |
Description | |
| 99.1 | Press Release of the Company dated March 30, 2015 | |
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 J. Belbel | |||||||
| Date: March 30, 2015 | Name: | Caesar J. Belbel | ||||||
| Title: | Executive Vice President and Chief Legal Officer | |||||||
INDEX OF EXHIBITS
| Exhibit |
Description | |
| 99.1 | Press Release of the Company dated March 30, 2015 | |
Exhibit 99.1
ZIOPHARM-Intrexon Synthetic Immuno-Oncology Programs Strengthened through Collaboration with Merck Serono
BOSTON, MA and GERMANTOWN, MD, March 30, 2015 – ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) and Intrexon Corporation (NYSE: XON) today announced their oncology programs will be strengthened through Intrexon’s new global collaboration focused exclusively on novel chimeric antigen receptor T-cell (CAR-T) products with Merck Serono, the biopharmaceutical division of Merck KGaA, Darmstadt, Germany. Intrexon will share the economic provisions of this collaboration, including upfront payment, milestones and royalties, equally with ZIOPHARM.
Under the collaboration Merck Serono will elect CAR-T targets, two initially, for which it will provide certain research funding. Through its agreement with Intrexon, ZIOPHARM will be responsible for any additional research and development expenditures. Once these candidates reach investigational new drug (IND) stage, the programs will be transferred to Merck Serono for clinical development and commercialization. ZIOPHARM and Intrexon will also independently conduct research and development on other CAR-T candidates, with Merck having the opportunity during clinical development to opt-in. ZIOPHARM’s other oncology programs will continue through its Exclusive Channel Collaboration (ECC) with Intrexon.
“Controlled CAR-T treatments hold the promise of delivering the powerful benefit of a targeted immune response to cancer with the ability to modulate immune toxicity, leading to safer, more efficacious treatments,” said Jonathan Lewis, M.D., Ph.D., Chief Executive Officer of ZIOPHARM. “The collaboration with Merck Serono brings world-class resources to our development efforts that greatly enhance our ability to translate CAR-T therapies from bench to bedside.”
“Harnessing the power of the immune system in a regulated manner is key to address the challenges of current CAR-T approaches and combat malignancies with adoptive cell therapies,” said Gregory Frost Ph.D., Senior Vice President and Head of Intrexon’s Health Sector. “We believe our alliances with Merck Serono and ZIOPHARM will accelerate progress in our synthetic immuno-oncology pipeline and drive next-generation medicines to market.”
R.J. Kirk, Chairman and CEO of Intrexon, commented, “The success of our partners is our #1 goal so it is gratifying for us to see the progress being made in the programs initiated under our ECC with ZIOPHARM. We look forward to seeing this progress accelerating in the coming months and years.”
About ZIOPHARM
ZIOPHARM Oncology is a Boston, Massachusetts-based biotechnology company employing novel gene expression, control and cell technologies to deliver safer, more effective and scalable cell-based therapies for the treatment of cancer. The Company’s synthetic immuno-oncology programs, in collaboration with Intrexon Corporation and the MD Anderson Cancer Center, include chimeric antigen receptor T cell (CAR-T) and other adoptive cell based approaches that use non-viral gene transfer methods for broad scalability. The Company is advancing programs in multiple stages of development together with Intrexon Corporation’s RheoSwitch Therapeutic System® technology, a switch to turn on
and off, and precisely modulate, gene expression in order to improve therapeutic index. The Company’s pipeline includes a number of cell-based therapeutics in both clinical and preclinical testing which are focused on hematologic and solid tumor malignancies.
About Intrexon Corporation
Intrexon Corporation (NYSE: XON) is a leader in synthetic biology focused on collaborating with companies in Health, Food, Energy, Environment, and Consumer sectors to create biologically-based products that improve the quality of life and the health of the planet. Through the Company’s proprietary UltraVector® platform and integrated technology suite, Intrexon provides its partners with industrial-scale design and development of complex biological systems delivering unprecedented control, quality, function, and performance of living cells. We call our synthetic biology approach Better DNA®, and we invite you to discover more at www.dna.com.
Safe Harbor Statement
This press release contains certain forward-looking information about ZIOPHARM Oncology, Inc. and Intrexon Corporation 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, and can be identified by terms such as “may,” “will,” “should,” “expects,” “plans,” “believes,” and “estimates.” These statements include, but are not limited to, statements regarding the progress, timing and results of preclinical and clinical trials; and the progress of research and development programs. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of ZIOPHARM or Intrexon, 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 chimeric antigen receptor T cell (CAR-T) based therapies will advance further in the pre-clinical or 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 CAR-T based therapies will be successfully marketed if approved; whether any of ZIOPHARM’s other therapeutic product discovery and development efforts will be successful; ZIOPHARM and Intrexon’s ability to achieve the results contemplated by their collaboration agreements; the strength and enforceability of the companies’ intellectual property rights; competition from other pharmaceutical and biotechnology companies; the development of, and the companies’ ability to take advantage of, the market for their therapeutic products; ZIOPHARM and Intrexon’s ability to raise additional capital to fund their operations on terms acceptable to the companies; and the other risk factors contained in ZIOPHARM and Intrexon’s periodic and interim SEC reports filed from time to time with the Securities and Exchange Commission, including but not limited to, their respective Annual Reports on Form 10-K for the fiscal year ended December 31, 2014. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and neither ZIOPHARM nor Intrexon 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.
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For more information contact:
ZIOPHARM Oncology contacts:
Lori Ann Occhiogrosso
Director of Corporate Communication
617-259-1987
locchiogrosso@ziopharm.com
David Pitts or Eliza Schleifstein
Argot Partners
212-600-1902
david@argotpartners.com
eliza@argotpartners.com
Intrexon Corporation contacts:
Corporate:
Marie Rossi, Ph.D.
Senior Manager, Technical Communications
Tel: +1 (301) 556-9850
publicrelations@intrexon.com
Investor:
Christopher Basta
Vice President, Investor Relations
Tel: +1 (561) 410-7052
investors@intrexon.com