Ziopharm Oncology, Inc. (“Ziopharm” or the “Company”) (Nasdaq:
ZIOP), today announced financial results for the third quarter
ended September 30, 2021 and provided a business update.
“I am impressed by the quality and dedication of
our team at Ziopharm who all are diligently working to transform
our cutting-edge scientific research into meaningful clinical
progress. Last quarter we made the decision to restructure the
organization and focus our efforts on advancing our differentiated
TCR-T library towards the clinic,” said Kevin S. Boyle, Sr., Chief
Executive Officer at Ziopharm Oncology. “We are making excellent
progress to operationalize our in-house cGMP clinical production
unit. We completed the necessary engineering and process
qualification runs in October and remain committed to begin
treating patients in the first half of 2022. Our team is executing
on this disciplined strategy to bring value to our stakeholders and
improve the lives of cancer patients.”
Recent Developments and Upcoming
Milestones:
TCR-T Library Clinical Program:
Ziopharm’s planned Phase 1/2 TCR-T Library study will be a basket
trial and enroll patients with non-small cell lung cancer,
colorectal, endometrial, pancreatic, ovarian and cholangiocarcinoma
where a matching neoantigen TCR/HLA pairing is available in the
Company’s TCR-T library. Using the Company’s Sleeping Beauty
transposon/transposase technology, patients will be infused with
autologous T-cells that have been engineered to express T-cell
receptors that are reactive against mutated neoantigens. Patients
will be enrolled in one of three progressing TCR-T cells dose
levels. The primary endpoint of the initial phase of the study will
be to determine the Maximum Tolerated Dose (MTD) or optimal TCR-T
cells dose. Ziopharm continues to expect to dose the first patient
in the TCR-T Library Phase 1/2 clinical trial in the first half of
2022.
cGMP clinical production unit
(CPU): Ziopharm continues to develop its in-house cGMP CPU
in Houston, TX, which is expected to operationalize in the first
half of 2022 to support the manufacturing of TCR-T therapies for
Ziopharm’s Phase 1/2 TCR-T library trial. In the third quarter, the
Company continued to make progress in establishing these
manufacturing capabilities, and in October, completed engineering
and process qualification runs in the CPU.
Expanding library of TCRs through a
robust R&D discovery engine: The Company continues to
qualify new TCRs using its Sleeping Beauty technology to further
expand the potential utility and applicable patient population for
its TCR-T Library. Ziopharm expects to file an amended
investigational new drug (IND) application for its TCR-T Library
clinical program in the next few months to include four additional
TCRs.
Corporate Updates:
Completed strategic
restructuring: In September 2021, Ziopharm announced a
greater than 50% reduction in personnel, enabling the Company to
extend its cash runway and prioritize advancing its lead TCR-T
library program towards the clinic.
Leadership Appointments: In
October 2021, Ziopharm announced that Michael Wong has been
appointed Vice President, Finance and Principal Accounting Officer.
Mr. Wong brings over 15 years of experience to Ziopharm. Most
recently he was Director of Technical Accounting at a large public
company.
Third Quarter Ended September 30, 2021
Financial Results:
Research and Development
Expenses: Research and development expenses were $14.5
million for the quarter ended September 30, 2021, as compared to
$14.0 million for the same period in 2020, an increase of
approximately 4%. The increase in research and development expense
was primarily due to a $2.2 million charge recognized during the
third quarter of 2021 related to our strategic restructuring
announced on September 27. The increase was primarily offset by
$1.6 million in reduced trial and consulting costs.
General and Administrative
Expenses: General and administrative expenses were $8.2
million for the quarter ended September 30, 2021, as compared to
$6.4 million for the same period in 2020, an increase of
approximately 29%. The increase in general and administrative
expenses was primarily due to $1.3 million in employee related
severance charges in association with our September 2021 strategic
restructuring recognized during the third quarter of 2021 and an
increase of $0.8 million related to consulting service costs. The
increases were partially offset by a $0.1 million decrease in
salary and employee related costs.
Net Loss: Net loss was $22.7
million, or $0.11 net loss per share, for the quarter ended
September 30, 2021, as compared to a net loss of $20.3 million, or
$0.10 net loss per share, for the same period in 2020. The increase
was primarily due to the severance charge of $3.5 million related
to our strategic restructuring.
Cash and Cash Equivalents: As
of September 30, 2021, Ziopharm had approximately $91.7 million in
cash and cash equivalents. Given its current development plans and
continued cost management efforts, the Company anticipates its cash
runway will extend into the second quarter of 2023.
Conference Call and Webcast
Ziopharm will host a conference call and webcast
today, November 8, 2021 at 4:30pm ET. Participants should dial
877-451-6152 (United States) or 201-389-0879 (International) with
the conference code 13724384. A live webcast may be accessed using
the link here, or by visiting the “Investors” section of the
Ziopharm website at www.ziopharm.com. After the live webcast, the
event will be archived on Ziopharm’s website for approximately 90
days after the call.
About Ziopharm Oncology,
Inc.Ziopharm is a clinical-stage cell therapy company,
focused on developing T-cell receptor (TCR) therapies for a wide
range of solid tumor indications. The Company’s non-viral Sleeping
Beauty gene transfer platform has enabled the development of a
unique TCR-T Library. This library of neoantigen-specific TCR-T
cells is able to effectively target tumor cells expressing
neoantigens including KRAS and TP53, while minimizing off-target
effects and toxicity. The Company has clinical and strategic
collaborations with The University of Texas MD Anderson Cancer
Center and the National Cancer Institute. 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 timing of activities relating to the Company’s
GMP facility, the execution of potential future partnerships or
transactions, 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 the most recent Form 10-Q and Form 10-K
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 Contact:Alex
LoboStern Investor RelationsAlex.lobo@sternir.com
ZIOPHARM
Oncology, Inc |
|
|
|
|
|
Statement of
Operations |
(unaudited) |
|
|
|
|
|
(in
thousands except per share data) |
|
|
|
|
|
|
|
For the
Three Months ended September 30, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
Collaboration revenue |
|
$ |
398 |
|
|
$ |
- |
|
Operating
expenses: |
|
|
|
|
Research and development |
|
|
14,521 |
|
|
|
13,968 |
|
General and administrative |
|
|
8,173 |
|
|
|
6,353 |
|
Total operating expenses |
|
|
22,694 |
|
|
|
20,321 |
|
Loss from operations |
|
|
(22,296 |
) |
|
|
(20,321 |
) |
Other income
(expense): |
|
|
|
|
Interest income (expense), net |
|
|
(444 |
) |
|
|
7 |
|
Other income (expense), net |
|
|
7 |
|
|
|
(1 |
) |
Other income
(expense), net |
|
|
(437 |
) |
|
|
6 |
|
Net loss |
|
$ |
(22,733 |
) |
|
$ |
(20,315 |
) |
Basic and
diluted net loss per share |
|
$ |
(0.11 |
) |
|
$ |
(0.10 |
) |
|
|
|
|
|
Weighted
average common shares outstanding |
|
|
|
|
basic and diluted |
|
|
214,542,465 |
|
|
|
212,837,367 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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ZIOPHARM
Oncology, Inc |
|
|
|
|
|
Selected
Balance Sheet Data |
(unaudited) |
|
|
|
|
|
|
|
September
30, |
|
December
31, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
91,725 |
|
|
$ |
115,069 |
|
Working capital |
|
$ |
68,381 |
|
|
$ |
112,221 |
|
Total assets |
|
$ |
113,762 |
|
|
$ |
146,345 |
|
Total stockholders’ equity |
|
$ |
68,707 |
|
|
$ |
123,982 |
|
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