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– Phase 2 trial of Sleeping Beauty TCR-T cell therapy for patients with solid tumors initiated at the National Cancer Institute (NCI) –
– New agreement with MD Anderson Cancer Center to expand library of T-cell receptors (TCRs) targeting neoantigens; Enables new clinical trials –
– Balance sheet strengthened in Q3; cash into H1 2021 –
– Company to host conference call and webcast today at 4:30 p.m. ET –
BOSTON, Nov. 07, 2019 (GLOBE NEWSWIRE) -- Ziopharm Oncology, Inc. (“Ziopharm” or the “Company”) (Nasdaq: ZIOP), today announced its financial results for the third quarter ended September 30, 2019, and provided an update on the Company’s recent activities.
“Our company took dramatic steps forward in the past quarter, in particular with our TCR-T platform,” said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm. “The NCI advanced the TCR program using our Sleeping Beauty platform into a phase 2 trial and our new agreement with MD Anderson accelerates expansion of our TCR library and sets the foundation for two new clinical trials to be conducted there by Ziopharm. Our confidence surges as we have partnered with these leading institutions in tackling the massive, untapped market in solid tumors.”
Sleeping Beauty TCR-T
The Company is using its non-viral gene transfer technology to implement personalized T-cell therapy targeting solid tumors with neoantigen-specific TCRs. Under a Cooperative Research and Development Agreement (CRADA), the NCI is undertaking a phase 2 clinical trial to treat patients with metastatic/advanced solid tumors using the Company’s Sleeping Beauty transposon/transposase platform to genetically modify patient-derived T cells with TCRs to target patient-specific neoantigens.
Sleeping Beauty CAR-T
Ziopharm is advancing the Sleeping Beauty platform for the rapid personalized manufacture (RPM) of CD19-specific CAR-T, co-expressing membrane bound IL-15 (mbIL15) with a safety switch. Per the IND, RPM produces T cells with viability of at least 70% that can be infused the day after gene transfer. This work on our third-generation Sleeping Beauty technology is undertaken in collaboration with MD Anderson Cancer Center in the United States and in Greater China through a joint venture, Eden BioCell.
Ziopharm is developing its Controlled IL-12 platform, or Ad-RTS-hIL-12 plus veledimex, to control the production of human interleukin 12 (hIL-12) which activates the immune system to recruit and sustain cancer-fighting T cells within solid tumors. Ziopharm is advancing Ad-RTS-hIL-12 plus veledimex for the treatment of recurrent glioblastoma multiforme (rGBM) as monotherapy and in combination with immune checkpoint inhibitors. In August, supportive data from the phase 1 monotherapy trial were published in Science Translational Medicine.
Third Quarter 2019 Financial Results
− Financial Tables Follow −
|ZIOPHARM Oncology, Inc.|
|Statements of Operations|
|(in thousands except share and per share data)|
|Three Months Ended|
|Research and development||8,641||8,263|
|General and administrative||4,807||4,307|
|Total operating expenses||13,448||12,570|
|Loss from operations||(13,448||)||(12,570||)|
|Other income, net||203||150|
|Change in fair value of derivative liabilities||-||(165||)|
|Noncash inducement warrant expense||(60,751||)||-|
|Preferred stock dividends||-||(6,074||)|
|Net Income (loss) applicable to common stockholders||$||(73,996||)||$||(18,659||)|
|Basic and diluted net loss per share||$||(0.43||)||$||(0.13||)|
|Weighted average common shares outstanding used|
|to compute basic and diluted net loss per share||170,613,712||141,185,404|
|ZIOPHARM Oncology, Inc.|
|Balance Sheet Data|
|September 30,||December 31,|
|Cash and cash equivalents||88,419||61,729|
|Total stockholders' equity||106,126||85,564|
Conference Call and Webcast
Scheduled for today at 4:30 pm ET, the conference call can be accessed by dialing 1-844-309-0618 (U.S. and Canada) or 1-661-378-9465 (international). The passcode for the conference call is 8286838. To access the live webcast or the subsequent archived recording, visit the "Investors" 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 an immuno-oncology company focused on developing end-to-end cost-effective solutions using its non-viral Sleeping Beauty platform for TCR and CAR T-cell therapies and immune-stimulating gene therapy with Controlled interleukin 12 (IL-12). The Sleeping Beauty platform genetically modifies T cells with DNA plasmids to express TCRs to target neoantigens inside and outside hotspots for solid tumors and CAR to target CD19 for blood cancers using the Company’s RPM to produce and release CAR-T as soon as the day after gene transfer. The Sleeping Beauty platform is being advanced in collaboration with the National Cancer Institute, The University of Texas MD Anderson Cancer Center and Eden BioCell. The Company is also developing its Controlled IL-12 platform, or Ad-RTS-hIL-12 plus veledimex, as monotherapy and in combination with immune checkpoint inhibitors to treat brain cancer, including in collaboration with Regeneron Pharmaceuticals.
Forward-Looking Statements Disclaimer
This press release contains forward-looking statements as defined in 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 business and strategic plans, the availability of cash resources, the progress and timing of the Company's research and development programs, including the anticipated dates for the initiation, completion and readouts of its clinical trials and the Company’s expectations regarding the number of patients in its clinical trials. Although Ziopharm’s management team believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Ziopharm, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, changes in our operating plans that may impact our cash expenditures, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Ziopharm’s product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies and for which indication; the strength and enforceability of Ziopharm’s intellectual property rights; competition from other pharmaceutical and biotechnology companies as well as risk factors discussed or identified in the public filings with the Securities and Exchange Commission made by Ziopharm, including those risks and uncertainties listed in Ziopharm’s Quarterly Report on Form 10-Q filed by Ziopharm with the Securities and Exchange Commission. We are providing this information as of the date of this press release, and Ziopharm does not undertake any obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason.
VP, Investor Relations and Corporate Communications
Lisa M. Wilson
In-Site Communications, Inc.