Full Press Release Details
Ziopharm Oncology Provides Leadership and Corporate Updates; Reports
Fourth Quarter and Full Year 2020 Financial Results
Heidi Hagen Appointed Interim Chief Executive Officer Replacing Dr. Laurence Cooper;
Search for Permanent CEO Initiated
Dr. Laurence Cooper Expected to Continue with Company in a Scientific Advisory Role
James Huang Appointed Executive Chairman and Board Refreshment Completed
FDA IND Clearance Announced for Groundbreaking Library TCR-T Phase I/II Clinical Trial,
Targeting Six Hotspot Mutations in KRAS and TP53
Further Details Provided on R&D Day on March 11 Including Participation of Dr. Steven Rosenberg,
Dr. Carl June, and Dr. Scott Kopetz
Boston, February 25, 2021 (GLOBE NEWSWIRE) Ziopharm Oncology, Inc. ( Ziopharm or the Company ) (Nasdaq: ZIOP), today
announced its financial results for the fourth quarter and year ended December 31, 2020 and provided several additional corporate updates. The Company will host a conference call and webcast today at 4:30 pm ET.
Leadership Transition and Planning
today announced that Heidi Hagen, formerly Lead Independent Director, has been appointed Interim Chief Executive Officer, replacing Dr. Laurence Cooper, MD., Ph.D. effective February 25, 2021. Ms. Hagen is remaining a member of the
Dr. Cooper is also stepping down from his seat on the Board of Directors and is expected to continue with the Company in a
scientific advisory capacity to support the Company s R&D programs. A search for a permanent Chief Executive Officer is underway.
Dr. Cooper said, With the fantastic news we announced today regarding the IND clearance of our Library
TCR-T clinical studies, the Company is well positioned as a leader in immuno-oncology using engineered T-cells. I will work with the Board on transitioning to an
role to support the organization on the science side, while allowing the Company to identify a complementary business leader who can drive our path to commercialization.
Ms. Hagen added, One cannot overstate Laurence s contribution to Ziopharm. His life s work has been to bring innovation and hope to
patients suffering from the devastating impact of cancer. We will continue down the path Laurence has laid before us, and look forward to his continued involvement to help us address the scientific challenges ahead.
Ms. Hagen has served on the Board since June 2019. She is co-founder of Vineti, a cloud-based software platform
company that addresses challenges in data management from order through cell collection, manufacturing, and delivery of personalized treatments such as cell and gene therapies and cancer vaccines. She has extensive experience in operations
management and commercializing innovative technologies.
The Company also announced today that James Huang has been appointed Executive Chairman of the
Board effective February 25, 2021.
Mr. Huang said, On behalf of the entire Board we thank Laurence for his leadership and vision and
express our full support for Heidi while we conduct a comprehensive search for a permanent CEO. We will strive to identify a leader with the business acumen to drive critical portfolio, development, commercial planning and capital allocation
decision making that will help ensure the success of the Company.
Mr. Huang has served on the Board since July 2020 and has served as Chairman
since January 2021. He is currently a Managing Partner at Kleiner Perkins Caufield & Byers (KPCB) China. He has founded and financed several innovative life sciences companies, including GenScript, Legend Biotech and Zai Lab. He is also
Founding Partner of Panacea Venture, which formed TriArm Therapeutics, the funding partner for Ziopharm s joint venture, Eden BioCell.
Clearance for the Company s Library TCR-T Clinical Phase I/II Trial
The Company today announced it
has received IND clearance by the U.S. Food and Drug Administration (FDA) for the Company s TCR-T trial utilizing six hotspot TCRs from its library. The Company anticipates enrolling patients
in the Phase I/II clinical trial across a variety of solid tumor cancers in the second half of the year.
The Company is working closely with MD Anderson
to begin identifying patients for this trial. The trial will address a range of solid tumors, across gynecologic, colorectal, pancreatic, non-small cell lung and cholangiocarcinoma cancers.
We are very excited to have received clearance for this IND and look forward to initiating the Library TCR-T
trial, representing a tremendous amount of work by the team and the culmination of efforts by so many dedicated employees, said Dr. Eleanor de Groot, Ph.D., Executive Vice
President and General Manager of Cell Therapy of Ziopharm. We believe our cell therapy Sleeping Beauty platform technology has the potential to deliver
non-viral engineered T-cell therapies to address significant unmet patient need and are excited by this important transition to clinical development for the Library
Additional Details Regarding R&D Day March 11, 2021
The Company provided additional details regarding the previously announced virtual R&D Day focusing on cell therapy on Thursday, March 11, 2021 at
11:00 am ET. Members of Ziopharm s management team will provide an overview of the Company s strategy, programs, and pipeline.
also include presentations by leading key opinion leaders: Dr. Steven Rosenberg, Chief of Surgery at the National Cancer Institute; Dr. Carl June, Chair of the Ziopharm Scientific Advisory Board and Director of the Center for Cellular
Immunotherapies and Director of Translational Research in the Abramson Cancer Center of the University of Pennsylvania; and Dr. Scott Kopetz, Colorectal Cancer Physician Scientist, NCI Colon Task Force Chair, Professor, and Deputy Chair at The
University of Texas, MD Anderson Cancer Center.
We are very excited to share updates on our suite of distinctive cell therapy programs and
delighted to have top key opinion leaders joining us to provide their views and perspectives. We will be highlighting the unique attributes of Ziopharm and the encouraging progress in our programs, said Dr. Raffaele Baffa, M.D., Ph.D.,
Chief Medical Officer of Ziopharm.
Fourth Quarter 2020 Financial Results
Full Year 2020 Financial Results
Fourth Quarter and Full Year 2020 Results Conference Call and Webcast Details
Ziopharm will host a conference call and webcast for the investment community today, February 25, 2021, at 4:30 pm ET. The conference call can be accessed
by dialing 877-451-6152 (U.S. and Canada) or
+1-201-389-0879 (International). The passcode for the conference call is 13715482. To access the live webcast or the subsequent
archived recording, click here or 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 90 days.
R&D Day Conference Call and Webcast Details March 11, 2021, 11:00am ET
Interested participants can register for and view the webcast using this link or by visiting the Investors section of the Ziopharm website
at www.ziopharm.com. The live Q&A session can be accessed by dialing 866-548-4713 (U.S. and Canada) or +1-323-794-2093 (International). The conference ID for the call is 5859801. The session will be recorded and available for replay on the Company s website for 90
About Ziopharm Oncology, Inc.
developing non-viral and cytokine-driven cell and gene therapies that weaponize the body s immune system to treat the millions of people globally diagnosed with cancer each year. With its multiplatform
approach, Ziopharm is at the forefront of immuno-oncology. Ziopharm s pipeline is built for commercially scalable, cost effective T-cell receptor T-cell therapies
based on its non-viral Sleeping
Beauty gene transfer platform, a precisely controlled IL-12 gene therapy, and rapidly manufactured Sleeping Beauty-enabled CD19-specific CAR-T program. The Company has clinical and strategic collaborations with the National Cancer Institute, The University of Texas MD Anderson Cancer Center and Regeneron Pharmaceuticals. For more information, please
visit www.ziopharm.com.
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 its capital resources, the Company s organization and leadership, and the
progress, design and timing of the Company s research and development programs, including the anticipated dates for enrolling 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
Eden BioCell s operating plans that may impact its 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 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.
Adam D. Levy, Ph.D., MBA
EVP, Investor Relations and Corporate Communications
LifeSci Communications
ZIOPHARM Oncology, Inc.
Statements of Operations
(in thousands except share and per share data)
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| (unaudited) | (unaudited) | (audited) | ||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 13,971 | $ | 10,216 | $ | 52,696 | $ | 38,331 | ||||||||
| General and administrative | 8,803 | 5,820 | 27,665 | 19,527 | ||||||||||||
| Total operating expenses | 22,774 | 16,036 | 80,361 | 57,858 | ||||||||||||
| Loss from operations | (22,774 | ) | (16,036 | ) | (80,361 | ) | (57,858 | ) | ||||||||
| Other income (expense), net | 2 | 290 | 385 | 813 | ||||||||||||
| Noncash inducement warrant expense | (60,751 | ) | ||||||||||||||
| Net loss | (22,772 | ) | (15,746 | ) | (79,976 | ) | (117,796 | ) | ||||||||
| Basic and diluted net loss per share | $ | (0.11 | ) | $ | (0.09 | ) | $ | (0.38 | ) | $ | (0.70 | ) | ||||
| Weighted average common shares outstanding used to compute basic and diluted net loss per share | 213,028,832 | 179,522,225 | 209,636,456 | 167,952,114 |
ZIOPHARM Oncology, Inc.
| December 31, | ||||||||
| (unaudited) | (audited) | |||||||
| 2020 | 2019 | |||||||
| Cash and cash equivalents | $ | 115,069 | $ | 79,741 | ||||
| Working capital | $ | 112,221 | $ | 92,966 | ||||
| Total assets | $ | 146,345 | $ | 109,114 | ||||
| Total stockholders equity | $ | 123,982 | $ | 95,010 |