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
PlanningThe Company 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
Board of Directors.
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 advisory 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.
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 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 program.”
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.
The session will 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
- Research and development expenses
were $14.0 million for the fourth quarter of 2020, compared to
$10.2 million for the fourth quarter of 2019, primarily reflecting
increased clinical trial activity.
- General and administrative expenses
were $8.8 million for the fourth quarter of 2020, compared to $5.8
million for 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, 2020 were $115.1 million. This cash position is
sufficient to fund Company operations into the second quarter of
2022.
- A prepayment of approximately $8.1
million remains 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, 2020 was $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 million for the year ended December 31, 2020, compared
to $38.3 million for the year ended December 31, 2019. The increase
in research and development expenses for the year ended December
31, 2020 is primarily due to increased manufacturing, headcount,
and clinical trial activity.
- General and administrative expenses
were $27.7 million for the year ended December 31, 2020, compared
to $19.5 million for the year ended December 31, 2019. The increase
in general and administrative expenses for the year ended December
31, 2020 is primarily due to increased legal costs, investor
relations costs and facility charges.
Fourth Quarter and Full Year 2020
Results Conference Call and Webcast DetailsZiopharm 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 ETInterested
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 days.
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
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 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.
Investor Relations:Adam D. Levy, Ph.D., MBAEVP,
Investor Relations and Corporate CommunicationsT:
508.552.9255E: alevy@ziopharm.com
Media Relations: LifeSci
CommunicationsPatrick BurseyT:
646.876.4932E: pbursey@lifescicomms.com
ZIOPHARM
Oncology, Inc. |
Statements
of Operations |
(in
thousands except share and per share data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
Year
Ended |
|
December
31, |
|
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. |
|
|
|
|
Balance
Sheet Data |
|
|
|
|
(in
thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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