ZIOPHARM Oncology, Inc.
May 1, 2017
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ZIOPHARM Oncology Reports First Quarter 2017 Financial Results and Provides Update on Recent Activities

— Advancing Plans to Initiate Pivotal Study 
for Ad-RTS-hIL-12 + Veledimex for Treatment of Recurrent Brain Cancer —

- Company to Host Conference Call Today at 4:30 p.m. ET -

BOSTON, May 01, 2017 (GLOBE NEWSWIRE) -- ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on new immunotherapies, today announced its financial results for the first quarter ended March 31, 2017, and provided an update on the company's recent activities.

"ZIOPHARM is making significant advances, including progress towards finalizing a registration path for Ad-RTS-hIL-12 + veledimex for recurrent glioblastoma and furthering development in our point-of-care approach with T-cell CAR-based therapies," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM Oncology. "ZIOPHARM is assessing several paths for the pivotal trial, including a single-arm study of Ad-RTS-hIL-12 + veledimex compared to historical controls. With a commercialization path in view, we are evaluating partnership opportunities for Ad-RTS-hIL-12 + veledimex to understand the breadth of options available to ZIOPHARM for bringing this important therapeutic candidate to patients."

"The IL-12 data from the brain cancer trial firmly establishes that the RheoSwitch Therapeutic System® works as a switch in humans," added Dr. Cooper. "By combining the most clinically advanced non-viral gene integration platform, Sleeping Beauty, and transcriptional switch system, RheoSwitch, we will use our point-of-care approach to significantly shorten the time to manufacture T cells and to tailor the expression of introduced genes after infusion using veledimex. This will address two major issues with CAR-based therapies, namely the cost of therapy and control of T cells to reduce toxicity."

Recent Updates

Ad-RTS-hIL-12 + veledimex

Ad-RTS-hIL-12 + veledimex is ZIOPHARM's gene therapy candidate for the controlled expression of interleukin-12 (IL-12), a critical protein for stimulating an anti-cancer immune response, using a RheoSwitch Therapeutic System® (RTS®) inducible gene-delivery system, or switch, that enables controlled in vivo expression of therapeutic proteins. ZIOPHARM is currently conducting a multi-center Phase 1 study of Ad-RTS-hIL-12 + orally administered veledimex in patients with recurrent or progressive glioblastoma multiforme (GBM), an aggressive form of brain cancer.

ZIOPHARM will be presenting updated results from its Phase 1, multicenter, dose-escalation study of Ad-RTS-hIL-12 + veledimex in patients with recurrent or progressive glioblastoma at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting on June 5, 2017.

"Our initial discussions with regulators have been encouraging, and we look forward to moving Ad-RTS-hIL-12 + veledimex into a pivotal study as quickly as possible this year. Details of the pivotal Phase 3 trial will be made available following completion of discussions with regulators and clinical advisors," said Francois Lebel, M.D., Executive Vice President, Research and Development, Chief Medical Officer at ZIOPHARM. "We continue to see encouraging outcomes in our Phase 1, multi-center study of Ad-RTS-hIL-12 + veledimex in patients with recurrent high-grade gliomas and plan to share updated results from this study at ASCO."

The Company also expects to initiate Phase 1 studies of Ad-RTS-hIL-12 + veledimex in pediatric brain cancer, as well as in combination with an anti-PD-1 checkpoint inhibitor in adult glioblastoma, as planned, in the first half of 2017.

Adoptive Cell Therapies

ZIOPHARM is developing chimeric antigen receptor (CAR) T cell (CAR+ T), T-cell receptor (TCR) T cell (TCR+ T), and natural killer (NK) adoptive cell-based therapies. These programs are being advanced in collaboration with Intrexon Corporation, MD Anderson Cancer Center, the National Cancer Institute and Merck Serono, the biopharmaceutical business of Merck KGaA (CAR+ T only).

Anticipated and Achieved 2017 Milestones

First-Quarter 2017 Financial Results

Conference Call and Slide Webcast
ZIOPHARM will host a conference call and webcast slide presentation today, Monday, May 1, 2017, at 4:30 p.m. ET. The call can be accessed by dialing (844) 309-0618 (U.S. and Canada) or (661) 378-9465 (international). The passcode for the conference call is 8375689. To access the slides and live audio webcast, or the subsequent archived recording, visit the "Investors & Media" section of the ZIOPHARM website at www.ziopharm.com. The webcast will be recorded and available for replay on the Company's website for two weeks.

About ZIOPHARM Oncology, Inc. ZIOPHARM Oncology is a Boston, Massachusetts-based biotechnology company employing novel gene expression, control and cell technologies to deliver safe, effective and scalable cell- and viral-based therapies for the treatment of cancer and graft-versus-host-disease. The Company's immuno-oncology programs, in collaboration with Intrexon Corporation (NYSE:XON) 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.

Forward-Looking Safe-Harbor Statement
This press release contains certain forward-looking information about ZIOPHARM Oncology, Inc. 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 in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding the Company's plans and expectations regarding its securities offerings, fundraising activities and financial strategy, the progress, timing and results of preclinical and clinical trials involving the Company's drug candidates, and the progress of the Company's 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 the Company, that could cause actual results to differ materially from those expressed in, or implied by, the forward-looking statements. These risks and uncertainties include, but are not limited to: our ability to finance our operations and business initiatives and obtain funding for such activities, whether chimeric antigen receptor T cell (CAR+ T) approaches, Ad-RTS-hIL-12, TCR and NK cell-based therapies, or any of our other therapeutic candidates will advance further in the preclinical 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 chimeric antigen receptor T cell (CAR+ T) approaches, Ad-RTS-hIL-12, TCR and NK cell-based therapies, and our other therapeutic products will be successfully marketed if approved; the strength and enforceability of our intellectual property rights; competition from other pharmaceutical and biotechnology companies; 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, 2016 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2017. 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.

Trademarks
RheoSwitch Therapeutic System® and RTS® are registered trademarks of Intrexon Corporation.

(tables follow)

ZIOPHARM Oncology, Inc.
Statements of Operations
(in thousands except share and per share data)
(unaudited)
        
   Three Months Ended
   March 31,
    2017    2016  
      
Collaboration revenue  $  1,597  $  1,969 
      
Operating expenses:     
Research and development, including cost of contracts    11,967     10,199 
General and administrative     3,595     3,810 
Total operating expenses     15,562     14,009 
      
Loss from operations     (13,965)    (12,040)
      
Other income (expense), net     38     21 
Change in derivative liabilities     (1,560)    - 
Net loss     (15,487)    (12,019)
Preferred stock dividends     (4,171)    -  
Net loss applicable to common stockholders $  (19,658) $  (12,019)
      
      
Basic and diluted net loss per share  $  (0.15) $  (0.09)
      
Weighted average common shares outstanding used to compute basic and diluted net loss per share  130,696,400   130,157,927 


ZIOPHARM Oncology, Inc.
Balance Sheet Data
(in thousands)
(unaudited)
         
  March 31, December 31,
  2017  2016 
     
Cash and cash equivalents   66,447    81,053 
Working capital   77,030    89,075 
Total assets   94,494    106,348 
Total stockholders' equity (deficit)   (94,903)   (77,298)

 

Contact:
Amy Trevvett
Vice President, Corporate Communications 
and Investor Relations
617-502-1881
atrevvett@ziopharm.com

David Pitts
Argot Partners
212-600-1902
david@argotpartners.com