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– FDA Cleared IND for Phase 1 Trial of Sleeping Beauty TCR-T cell therapy for
patients with solid tumors at the National Cancer Institute (NCI) –
– Exclusive license from NCI for library of T-cell receptors (TCRs) targeting neoantigens in the hotspots KRAS, p53 and EGFR –
– Balance sheet strengthened with $45 million in proceeds from early warrant exercise –
– NCI’s Dr. Drew Deniger to direct TCR program; Sath Shukla named CFO –
– Company to host conference call and webcast today at 8:30 a.m. ET –
BOSTON, Aug. 08, 2019 (GLOBE NEWSWIRE) -- Ziopharm Oncology, Inc. (“Ziopharm” or the “Company”) (Nasdaq: ZIOP), a clinical stage immuno-oncology company developing next generation cell and gene therapies, today announced its financial results for the second quarter ended June 30, 2019, and provided an update on the Company’s recent activities.
“We have made significant advancements in our programs during the second quarter. The FDA cleared the IND for the first non-viral, neoantigen-specific TCR-T cell therapy at the NCI using our Sleeping Beauty system and we announced an exclusive license to an expansive library of TCRs against neoantigens in three of the most important hotspot families,” said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm. “In our Controlled IL-12 program, we completed enrollment of the third dosing cohort in our phase 1 combination trial with nivolumab and initiated a phase 2 combination trial with Regeneron’s Libtayo®. Finally, we refined our plans for the third-generation Sleeping Beauty CD19-specific CAR-T phase 1 trial at MD Anderson Cancer Center, which we continue to expect to commence later this year.”
David Mauney, M.D., President of Ziopharm, added, “As our clinical programs continue to advance, we have strengthened our balance sheet and expanded the breadth and depth of our corporate leadership. We are proud to welcome Sath Shukla and Dr. Drew Deniger to our leadership team and Heidi Hagen to our Board of Directors. We are grateful that through the support of key shareholders who exercised their existing warrants several years prior to expiration, we added $45 million to our treasury to provide us with cash into the first half of 2021, which we expect will allow us to see data readouts in the three programs.”
Since the beginning of the second quarter, Ziopharm has announced positive corporate developments regarding expansion of the management team and strengthening of the company’s balance sheet.
Sleeping Beauty TCR-T Therapies
The Company is using its non-viral gene transfer technology to implement personalized T-cell therapy targeting solid tumors with TCRs. Under a Cooperative Research and Development Agreement (CRADA), the NCI is initiating a 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 Therapies
Ziopharm is advancing the Sleeping Beauty platform for the rapid personalized manufacture (RPM) of CAR-T cells, co-expressing membrane-bound interleukin-15, or mbIL15, with a safety switch, enabling T cells to be infused within two days after genetic modification. 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 a monotherapy and in combination with immune checkpoint inhibitors.
Second 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||9,998||7,489|
|General and administrative||4,755||4,889|
|Total operating expenses||14,753||12,378|
|Loss from operations||(14,753||)||(12,378||)|
|Other income (expense), net||133||164|
|Change in fair value of derivative liabilities||-||183|
|Preferred stock dividends||-||(5,462||)|
|Net Income (loss) applicable to common stockholders||$||(14,620||)||$||(17,493||)|
|Basic and diluted net loss per share||$||(0.09||)||$||(0.12||)|
|Weighted average common shares outstanding used|
|to compute basic and diluted net loss per share||160,789,272||141,017,898|
|ZIOPHARM Oncology, Inc.|
|Balance Sheet Data|
|June 30,||December 31,|
|Cash and cash equivalents||43,563||61,729|
|Total stockholders' equity||61,995||85,564|
Conference Call and Webcast
The 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 8279471. 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 specific antigens in solid tumors and a CAR to target CD19 in blood cancers with the Company’s 3rd generation T-cell manufacturing process, termed “rapid personalized manufacture”. 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 also is 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