Ziopharm Oncology Reports First Quarter 2021 Financial Results and Provides Corporate Updates
May 06 2021 - 4:02PM
Ziopharm Oncology, Inc. (“Ziopharm” or the “Company”) (Nasdaq:
ZIOP), today announced its financial results for the first quarter
ended March 31, 2021 and provided additional corporate updates. The
Company will host a conference call and webcast today at 4:30 pm
ET.
Recent Corporate Highlights and Updates
- Announced that the infusion of the first patient
in the CD19-Specific Rapid Personalized Manufacturing (RPM)
CAR-T Phase I Clinical Trial being conducted in Taiwan by the
Company’s Joint Venture partner, Eden BioCell, occurred
in March.
- Presented a poster entitled “Hotspot mutations in KRAS and TP53
targeted by TCR-T cells genetically modified with the Sleeping
Beauty transposon/transposase system” at the American Association
for Cancer Research (AACR) Virtual 2021 Annual Meeting.
- Completed construction of the GMP facility in Houston with
follow on activities for facility qualification and validation to
take place over the summer. The Company will then qualify the
manufacturing process in the facility and file an IND amendment to
enable GMP manufacturing to supplement its CMO partner's capacity
for the TCR-T hotspot trial.
- Announced it is winding down its existing Controlled IL-12
clinical program. Data indicated potential clinical benefits in a
variety of cancers, including recurrent glioblastoma. The Company
will continue to seek a partner for this program while re-deploying
resources and will explore synergies between this technology and
its cell therapy programs. The Company anticipates a headcount
reduction of approximately 15% related to this wind down.
- Anticipate the closure of the CD19 RPM CAR-T Allogeneic Phase I
Trial at MD Anderson Cancer Center. The trial closure is expected
to occur during the second or third quarter of 2021.
- Plans to hold its Annual Meeting of Stockholders on May 19,
2021 at 9:00 am EDT. The meeting will be held virtually.
Shareholders and interested stakeholders may attend the annual
meeting online using the link below. Shareholders may submit
questions during the meeting and vote shares electronically during
the meeting by visiting
www.virtualshareholdermeeting.com/ZIOP2021.
“Our first quarter was highlighted by execution and important
strategic decisions that focus our capital on our prioritized
development programs,” said Heidi Hagen, Chief Executive Officer of
Ziopharm. “In the coming months, we are focused on delivering
important milestones on our clinical trials, including our first
TCR-T trial, where we plan to treat patients beginning in the
second half of the year, and continued progress on the Eden BioCell
CD19-specific RPM CAR-T Trial in Taiwan.”
First Quarter 2021 Financial Results
- Research and development expenses were $13.3 million for the
first quarter of 2021, compared to $12.7 million for the first
quarter of 2020, primarily reflecting increase in cell therapy
program costs offset by a decrease in Controlled IL-12 program
costs.
- General and administrative expenses were $8.2 million for the
first quarter of 2021, compared to $6.0 million for the
first quarter of 2020. The increase in general and administrative
expenses is primarily due to increased employee related expenses
and legal costs associated with its expanded patent portfolio.
- Net loss for the first quarter of 2021, was $21.6 million, or
$(0.10) per share, compared to a net loss of $18.3 million, or
$(0.09) per share, for the first quarter of 2020.
- Cash and cash equivalents, as of March 31, 2021 were $100.1
million.
- Additionally, a prepayment of approximately $5.1
million remains for work to be conducted by the Company
at MD Anderson under the Company’s research and development
agreements.
Earnings Conference Call and Webcast Ziopharm
will host a conference call and webcast for the investment
community today, May 6, 2021, at 4:30 p.m. EDT. The conference call
can be accessed by dialing 855-327-6837 (U.S. and Canada)
or 631-891-4304 (International). The passcode for the conference
call is 10013973. The live webcast may be accessed using the link
here, or by visiting the “Investors” section of the Ziopharm
website at www.ziopharm.com. The call will be recorded and
available for replay on the Company’s website for approximately 90
days after the call.
Annual Meeting of StockholdersZiopharm will
host its annual meeting virtually on May 19, 2021 at 9:00 am.
Shareholders and interested stakeholders may attend the meeting,
submit questions, and vote their shares electronically during the
meeting by visiting
www.virtualshareholdermeeting.com/ZIOP2021.
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
rapidly manufactured Sleeping Beauty-enabled CD19-specific
CAR-T program and a precisely controlled IL-12 gene therapy. 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 DisclaimerThis 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 wind down
of the Company’s Controlled IL-12 clinical program, the anticipated
closure of the CD19 RPM CAR-T Allogeneic Phase I Trial at MD
Anderson Cancer Center, the timing of activities relating to the
Company’s GMP facility, and the timing of the Company's research
and development programs, including the anticipated dates for
enrolling patients in the Company’s TCR-T clinical trial. 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 the Company’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 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.
Investor Relations Contacts:Adam D. Levy,
Ph.D., MBAEVP, Investor Relations and Corporate CommunicationsT:
508.552.9255E: alevy@ziopharm.com
Media Relations Contact: LifeSci
Communications:Patrick BurseyT:
646.876.4932E: pbursey@lifescicomms.com
ZIOPHARM
Oncology, Inc |
|
|
|
|
|
|
|
Statement of
Operations |
|
(unaudited) |
|
|
|
|
|
|
|
(in
thousands except per share data) |
|
|
|
|
|
|
|
|
|
For the
Three Months ended March 31, |
|
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
Research and development |
|
$ |
13,336 |
|
|
$ |
12,706 |
|
|
General and administrative |
|
|
8,227 |
|
|
|
5,954 |
|
|
Total operating expenses |
|
|
21,563 |
|
|
|
18,660 |
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(21,563 |
) |
|
|
(18,660 |
) |
|
|
|
|
|
|
|
Other income, net |
|
|
9 |
|
|
|
367 |
|
|
Net loss |
|
$ |
(21,554 |
) |
|
$ |
(18,293 |
) |
|
|
|
|
|
|
|
Net income (loss) applicable to common stockholders |
|
$ |
(21,554 |
) |
|
$ |
(18,293 |
) |
|
|
|
|
|
|
|
Basic and
diluted net loss per share |
|
$ |
(0.10 |
) |
|
$ |
(0.09 |
) |
|
|
|
|
|
|
|
Weighted average number of common shares outstanding used |
|
|
|
|
to compute basic and diluted net loss per share |
|
|
213,954,665 |
|
|
|
199,814,768 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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|
|
|
|
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|
ZIOPHARM
Oncology, Inc |
|
|
|
|
|
|
|
Selected
Balance Sheet Data |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
March
31, |
|
December
31, |
|
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
100,056 |
|
|
$ |
115,069 |
|
|
Working capital |
|
$ |
93,749 |
|
|
$ |
112,221 |
|
|
Total assets |
|
$ |
128,472 |
|
|
$ |
146,345 |
|
|
Total stockholders' equity |
|
$ |
105,641 |
|
|
$ |
123,982 |
|
|
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