Full Press Release Details
Ziopharm Oncology Reports Second Quarter 2019
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, August 8, 2019 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
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 | ||||||||
| June 30, | ||||||||
| (unaudited) | ||||||||
| 2019 | 2018 | |||||||
| Collaboration revenue | $ | $ | ||||||
| Operating expenses: | ||||||||
| 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 | |||||||
| Net loss | (14,620 | ) | (12,031 | ) | ||||
| 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.
| June 30, | December 31, | |||||||
| 2019 | 2018 | |||||||
| Cash and cash equivalents | 43,563 | 61,729 | ||||||
| Working capital | 55,459 | 74,802 | ||||||
| Total assets | 73,173 | 95,051 | ||||||
| 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.
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
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
VP, Investor Relations and Corporate Communications