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): January 14, 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 January 14, 2015, ZIOPHARM Oncology, Inc., or the Company, will present the attached discussion of The Future of Cancer Therapy at the 33rd Annual J.P. Morgan Healthcare Conference in San Francisco, California, being held on January 12 - 15, 2015.
A copy of the above referenced presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K. 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 | Presentation of the Company dated January 14, 2015 | |
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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/ Kevin G. Lafond | |||||
| Date: January 14, 2015 | Name: | Kevin G. Lafond | ||||
| Title: | Vice President, Chief Accounting Officer and Treasurer | |||||
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INDEX OF EXHIBITS
| Exhibit No. |
Description | |
| 99.1 | Presentation of the Company dated January 14, 2015 | |
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| Exhibit 99.1
|
The Future of Cancer Therapy
JP Morgan 33rd Annual Healthcare Conference
January2015
www.ziopharm. com
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Forward_Looking Statements
This presentation _ forward contains certain looking information about ZIOPHARM Oncology that is intended to be covered by the safe harbor for “forward Forward looking statements” provided by the Private Securities Litigation Reform Act of 1995, as amended. 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 _ forward to identify looking statements. These statements include, but are not limited to, statements regarding our ability to successfully _ long develop and commercialize our therapeutic products, our ability to expand our 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 _ forward from those expressed in, or implied or projected by, the looking information and statements. These risks and uncertainties include, but are not limited to: whether any of our therapeutic candidates 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 any of our therapeutic candidates 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 DNA development of and our ability to take advantage of the market for based biotherapeutics; our ability to raise additional capital to fund our operations on terms acceptable to us; general economic conditions; and theotherriskfactors contained inour periodic andinterimreportsfiledwiththeSEC including, butnotlimitedto,ourannualreporton Form 10 K for the fiscal year ended December 31, 2013 and Quarterly 10 Report on Form Q for the period ended September 30, 2014, and other filings with the SEC, which are available at www.sec.gov. Our audience is 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 non date hereof, or to reflect the occurrence of or occurrence of any events.
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JP Morgan
Jonathan Lewis, M.D., Ph.D., CEO, ZIOPHARM Oncology
www.ziopharm. com
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Ad_RTS IL 12 Overview
Adenoviral Interleukin _ mediated controlled delivery of 12
Oral
RTS hIL Ad 12
Oral Activator Activator
Distant
Tumors
Intratumoral Injection Cytotoxic Response
Lymphatics
IL_12
IF
IFNg N
Draining Lymph Node
ZIOPHARM has leading expertise in clinical translation of designer cytokines
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Oral Veledimex Precisely Controls the Expression _IL of 12
ON
1000000
100000
vp)
6 10000
(mRNA/1e 1000
100
mRNA 10 or
OFF OFF
Tum 1
0.1
Baseline Maximum D1 D7 Post 7 Days treatment
100 mg 160 mg n=7 Veledimex Dose
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Next _ IL steps for 12
Moving to active immunotherapy
ZIOPHARM hasleading expertise inclinical translation of designer cytokines
RheoSwitch Therapeutic System® platform for conditional expression of
_ Immunoreceptors
_ Cytokines
ZIOPHARM is partnering with MDACC in Boston and Houston
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JP Morgan
Greg Frost, Ph.D., SVP Health Sector, Intrexon Corporation
www.ziopharm. com
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Non_Viral Adoptive Cellular Therapies
[Graphic Appears Here]
INTREXON and ZIOPHARM Announce Exclusive Licensing Agreement with MD Anderson Cancer Center for Chimeric Antigen Receptor (CAR) T Cell and Associated Technologies for the Development of Non_Viral Adoptive Cellular Therapies
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Resulting in Point of Care andOfftheShelf Cellular Solutions
PointofCareProduct OfftheShelfProduct
“ Integration with RheoSwitch® “ Genetically modify and edit T cells control of T cell propagation and to express CAR and eliminate TCR specificity in patients
“ AttSite® landing pads for precision
“ Facilitates a no _ culture solution to genetic engineering manufacturing
“ iPSC processing technologies combined with LEAP® to engineer _ HLA an matched product
Recombinases and Transposases
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Key Technology Synergies
Technology Intrexon / ZIOPHARM / MD Anderson
RheoSwitch Most advanced family of ligands and switches available Therapeutic System® for dynamic range, safety, and spatial/temporal control
Non _ Viral Integration Firstin human testing of Sleeping Beauty system in Platform hematopoietic cells
Industrialized assembly and screening of multigenic
UltraVector®
DNA modules for synthetic biology
Expertise in development and implementation of novel
Adoptive Cell Therapy immunotherapy trials
Established clinical pipeline for adoptive cellular therapies
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&With Traditional Oncology Reimbursement for Cellular Therapies
Avoids Acute PBM Pressures Driven by Cost Density
$ )
( $$$
dule
Reimbursement Sche $$ Failure Rate ents Pay $
Cell Reimbursement
Days
Weeks Months
Cell and Ligand Reimbursement Years
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JP Morgan
Laurence J.N. Cooper, M.D., Ph.D., Professor of Pediatrics at MD Anderson
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The technology being discussed has been licensed by MD Anderson to Ziopharm and Intrexon and MD Anderson, which is my employer, will have an equity interest in both companies as a result of the transaction. As an inventor of the licensed technology, I will share in the proceeds of the consideration received by MD Anderson under the license in accordance with UT System Rules and MD Anderson policies and to that extent, I have a financial interest in both companies.
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Increase in Patient Number Disrupts Manufacturing Scalability
# Patients (Few)
Manufacture Tcell T cells Infusion
Small Gap
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Point of Care and Off the Shelf Manufacturing
# Patients (Many)
Manufacture Tcell T cells Infusion
Large Gap
Small Gap
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Dual CAR _ Distribution Approaches for T
Genetically modified T cells
Onepatient Multiple Patients
_ Off
Specific Autologous T cells Allogeneic T cells the
s _ t
Patien Real time In advance of need helf
(OTS)
Disease cure Disease control
Point of _ care(POC) _ Centralized
Registration Trials & Global Distribution with Multiple Pharma Partners
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Steps Toward Point of Care Distribution
T cell Acquisition T cell Manufacturing Time
Self
Genetic Modification Infusion
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Steps Toward Off the Shelf Distribution
T cell Acquisition Autologous
Donor
mpan ies
Genetic
Modification Co
of #
Infusion Off the Shelf Allogeneic
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Portfolio of Effector Cells
1. Chimeric Antigen Receptor (CAR+) T cells:
Target cell surface tumor associated antigens (TAAs) independent of HLA
__Public antigens
2. T Cell Receptor (TCR+) cells:
Target intracellular TAAs dependent on HLA
__Private antigens
3. Natural Killer (NK) cells:
Target tumor with loss of HLA
_No _antigens_
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Improving Therapeutic Potential of CART Cells
CAR T Cells for improved potency and persistence
Understanding ofthe effector cellbiology Co _ stimulation CAR with cytokine
Signals 1 & 2 Signal 3
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RTS® Cell for Gene and based Therapies
+ Addition of activator ligand or control solvent
_ Withdrawal of activator ligand or control solvent
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Building Next the Generation of Inducible Cytokines
Therapeutic potential of effector cells depends on recognition of tumor cells and recycling effector function in tumor microenvironment.
Veledimex
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Management of Potential Toxicity through Inducible Immunoreceptor Expression
Many attractive target antigens are expressed on normal cells
or Veledimex
CAR+T Cell ll Inducible orecept CAR+T Cell ll immun TCR+T Cell ll Inducible
TCR+T Cell ll nducible I
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Advantages Non of Viral Gene Integration
Sleeping Beauty transposon/transposase system
Efficient andnimblegene transfer method
Bypasses the cost, viral time, and complexity of based delivery vectors
Transposon (IR/DR) DNA
SB Transposase
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Manufacturing Platform Defines Specificity & Potency
Effector Gene cells insertion
Gene editing
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Eliminating HLA and TCR on CAR+ T Cells for Universal Donor
_ non Recognize _non self_ (Patient ’ Donor) )
TCR±² T cells
HLAs HLAs
CD19
CAR
B _ cell leukemia/lymphoma
TCR±² HLAs
Healthy donor T cells
Re
(Donor ’Patient)
Artificial nuclease
Normal cells
Blood. 2013 Aug 22;122(8):1341 9_ Blood. 2012 Jun 14;119(24):5697 705 _
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Personalized Therapy for Disease and Patient
tumor _ Heterogeneity of associated antigen (TAA)
Intra Inter tumor tumor
Infuse T cells with more than one specificity Infuse T cells with one or more specificity
Personalized for the disease Personalized for the patient
_N=1_ trial paradigm
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www.ziopharm. com
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An Accelerated Synthetic Immunology Pipeline
Solid Tumors
Point of Off the
Care Shelf
Myeloid Malignancies B_cell malignancies
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An Accelerated Synthetic Immunology Pipeline
Compound Pre Clinical Phase 1 Phase 2
Ad-RTS-IL-12 IND
Breast/Melanoma
GBM
CAR/Cytokine Products
B-cell malignancies
Myeloid Malignancies
RTS-controlled T cell
Solid Tumors
Universal Donor
Up to 5 CARs entering clinic in 2015
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The Future of Cancer Therapy
JP Morgan 33rd Annual Healthcare Conference
January2015
www.ziopharm. com