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.
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
Leadership Transition and Planning
The Company today announced that
The Company also announced today that
FDA IND Clearance for the Company’s Library TCR-T Clinical Phase I/II Trial
The Company today announced it has received IND clearance by the
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.
Additional Details Regarding R&D Day
The Company provided additional details regarding the previously announced virtual R&D Day focusing on cell therapy on
The session will also include presentations by leading key opinion leaders: Dr.
“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.
Fourth Quarter 2020 Financial Results
- Research and development expenses were
$14.0 millionfor the fourth quarter of 2020, compared to $10.2 millionfor the fourth quarter of 2019, primarily reflecting increased clinical trial activity.
- General and administrative expenses were
$8.8 millionfor the fourth quarter of 2020, compared to $5.8 millionfor the fourth quarter of 2019. The increase in general and administrative expenses for the fourth quarter of 2020 is primarily due to increased legal costs, investor relations costs and facility charges.
- Net loss for the fourth quarter of 2020, was
$22.8 million, or $(0.11)per share, compared to a net loss of $15.7 million, or $(0.09)per share, for the fourth quarter of 2019.
- Cash and cash equivalents, as of
December 31, 2020were $115.1 million. This cash position is sufficient to fund Company operations into the second quarter of 2022.
- A prepayment of approximately
$8.1 millionremains for work to be conducted by the Company at MD Anderson under the Company’s research and development agreements.
Full Year 2020 Financial Results
- Net loss applicable to the common shareholders for the year ended
December 31, 2020was $80.0 million, or $(0.38)per share, basic and diluted, compared to net loss applicable to the common shareholders of $117.8 million, or $(0.70)per share, basic and diluted, for the year ended December 31, 2019.
- Research and development expenses were
$52.7 millionfor the year ended December 31, 2020, compared to $38.3 millionfor the year ended December 31, 2019. The increase in research and development expenses for the year ended December 31, 2020is primarily due to increased manufacturing, headcount, and clinical trial activity.
- General and administrative expenses were
$27.7 millionfor the year ended December 31, 2020, compared to $19.5 millionfor the year ended December 31, 2019. The increase in general and administrative expenses for the year ended December 31, 2020is primarily due to increased legal costs, investor relations costs and facility charges.
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,
R&D Day Conference Call and Webcast Details –
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 (
About Ziopharm Oncology, Inc.
Ziopharm is 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.
EVP, Investor Relations and Corporate Communications
|Statements of Operations|
|(in thousands except share and per share data)|
|Three Months Ended
|Research and development||$||13,971||$||10,216||$||52,696||$||38,331|
|General and administrative||8,803||5,820||27,665||19,527|
|Total operating expenses||22,774||16,036||80,361||57,858|
|Loss from operations||(22,774||)||(16,036||)||(80,361||)||(57,858||)|
|Other income (expense), net||2||290||385||813|
|Noncash inducement warrant expense||-||-||-||(60,751||)|
|Basic and diluted net loss per share||$||(0.11||)||$||(0.09||)||$||(0.38||)||$||(0.70||)|
|Weighted average common shares outstanding used
to compute basic and diluted net loss per share
|Balance Sheet Data|
|Cash and cash equivalents||$||115,069||$||79,741|
|Total stockholders' equity||$||123,982||$||95,010|
Source: ZIOPHARM Oncology Inc