Ziopharm Oncology Reports Financial Results for Fourth Quarter and Full Year 2019
March 02 2020 - 4:05PM
Ziopharm Oncology, Inc. (“Ziopharm” or the “Company”) (Nasdaq:
ZIOP), today announced its financial results for the fourth quarter
and year ended December 31, 2019 and provided a corporate update.
“In the 16 months since forging our corporate
independence, we have advanced all our clinical programs, licensed
critical intellectual property, recruited key personnel to the
Company and Board, and fortified our financial position,” said
Laurence Cooper, M.D., Ph.D., Chief Executive Officer. “In 2020, we
will use this foundation to accelerate our commercial pathway,
through enrollment at NCI to TCR-T trial, preparing TCR-T trials
with MD Anderson Cancer Center, data readouts on Controlled IL-12
in recurrent GBM and enrollment to trial of CAR-T infused day after
gene transfer.”
Significant 2019
Achievements
- NCI Phase 2 TCR Study. Under
the T-cell receptor (TCR) T-cell therapy program, an
investigational new drug (IND) application submitted by the
National Cancer Institute (NCI) received clearance from the U.S.
Food and Drug Administration (FDA) for a phase 2 clinical trial in
multiple solid tumors to evaluate use of the Sleeping Beauty
platform for TCR-T therapy.
- This trial represents a first-in-human non-viral TCR-T trial at
NCI.
- NCI has begun to screen patients for enrollment with patients
going through the TCR identification and procurement process; with
tumor resection, neoantigen identification, and TCRs made ready for
infusion.
- Study protocol details are available on Clinicaltrials.gov: A
Phase 2 Study Using the Administration of Autologous T-Cells
Engineered Using the Sleeping Beauty Transposon/Transposase System
to Express T-Cell Receptors Reactive Against Mutated Neoantigens in
Patients With Metastatic Cancer (NCT0402436).
- New MD Anderson Agreement. In October, the
Company entered into a lease agreement to expand its R&D
footprint and entered into a new Research and Development Agreement
with MD Anderson Cancer Center which:
- Enables Ziopharm-sponsored clinical studies at MD Anderson
based on the Sleeping Beauty non-viral gene transfer platform to
generate T cells targeting neoantigens in solid tumors; initially,
two approaches will be evaluated infusing autologous T cells
expressing TCRs with specificities for multiple private neoantigens
and administering autologous T cells expressing TCRs from a library
targeting shared neoantigens in hotspots.
- Accelerates expansion of the library, licensed from NCI earlier
in 2019, of TCRs against neoantigens in hotspots including mutated
KRAS, TP53 and EGFR.
- Phase 2 Combination Study for Controlled
IL-12. Under the Controlled IL-12
program, the Company initiated a phase 2 combination trial with
Regeneron’s Libtayo® to treat patients with recurrent glioblastoma
(rGBM).
- As prescribed in the study protocol, the Company expects to
enroll up to 36 patients at approximately 10 sites. Enrollment is
anticipated to be completed in 1H 2020.
- This phase 2 trial builds on experience from a phase 1
combination study with another PD-1 inhibitor,
OPDIVO®, which completed enrollment last year,
with additional data expected this year.
- Controlled IL-12 Clinical Data. Data
publications in 2019 at the American Society of Clinical Oncology
(ASCO) and Society for Neuro-Oncology (SNO) annual meetings showed
Controlled IL-12, as monotherapy or in combination with a PD-1
inhibitor, resulted in immune-mediated anti-tumor effects in the
setting of recurrent GBM. Encouraging results from the phase 1
monotherapy main trial were published in Science Translational
Medicine. These publications and presentations are available on
Ziopharm’s website.
- IND Cleared for CAR-T Study. Under the CAR-T
program, an IND was cleared by the FDA for a phase 1 clinical trial
to assess CD19-specific CAR-T, produced using Rapid Personalized
Manufacturing (RPM).
- Up to 24 patients will be enrolled to evaluate infusion of
donor-derived RPM CAR-T in patients with CD19+ leukemias and
lymphomas who have relapsed after allogeneic bone marrow
transplant. This study is being conducted at MD Anderson Cancer
Center as an investigator-initiated trial.
- The Company also expects partners at Eden BioCell to file an
IND for an autologous RPM CD19 trial this year in Taiwan.
- Expanded Team and Capabilities. The Company
experienced significant growth in 2019, with strategic hires
expanding capabilities and increasing staff nearly 50 percent to 73
employees at year end.
- Notably, Ziopharm welcomed Sath Shukla, formerly of Vertex
Pharmaceuticals, as Chief Financial Officer and Dr. Drew Deniger,
who previously worked under Dr. Steven Rosenberg at the NCI, to
lead the TCR program.
- Chris Bowden, M.D., and Heidi Hagen were appointed as
Directors, completing the repopulation of the Board as part of
Ziopharm’s reemergence as an independent company.
- Strengthened Balance Sheet.
Ziopharm completed 2019 with approximately $79.7 million in cash,
with another $20.3 million in capital pre-funded at MD Anderson
available for the Company’s program.
- Subsequent to the close of 2019, the Company raised
approximately an additional $98 million through recent financing
activities, Ziopharm has dramatically extended its funding horizon
and can accelerate the buildout of its TCR program in Houston and
the launch of Ziopharm-led TCR clinical trials for patients with
solid tumors.
Anticipated Milestones for the First
Half of 2020
- Sleeping Beauty Cell Therapy
Programs
- Patient dosing in the NCI-led phase 2 TCR-T trial targeting
solid tumors.
- Initiation of the CD19-specific CAR-T RPM phase 1 trial with
membrane bound IL-15 at MD Anderson.
- Controlled IL-12 Gene Therapy Program
- Complete enrollment and initial data readout for phase 2
combination trial with Libtayo®.
- Interim data readout of phase 1 combination trial with
OPDIVO®.
- Interim data readout from phase 1 monotherapy trial in expanded
cohort.
Fourth Quarter 2019 Financial
Results
- Net loss of the fourth quarter of 2019, was $15.7 million, or
$(0.09) per share, compared to net income of $194.5 million, or
$1.29 per share, for the fourth quarter of 2018. Net income for the
fourth quarter of 2018 reflects the forfeiture and return of all
the Company’s Series 1 preferred stock held by a former corporate
partner and the relinquishment of Ziopharm’s obligations under a
separate agreement, accounting for approximately $207 million.
- Research and development expenses were $10.2 million for
the fourth quarter of 2019, compared to $8.2 million for
the fourth quarter of 2018, primarily reflecting increased clinical
trial activity.
- General and administrative expenses were $5.8 million for the
fourth quarter of 2019, compared to $4.6 million for the
fourth quarter of 2018. The increase in general and administrative
expenses for the fourth quarter of 2019 is primarily due to
increased headcount, growth of intellectual property activity and
expanded clinical activity.
- The Company ended the fourth quarter 2019 with unrestricted
cash resources of approximately $79.7 million.
- In addition, a prepayment of approximately $20.3
million remains for work to be conducted by the Company
at MD Anderson under the Company’s Research and Development
Agreements.
Full Year 2019 Financial
Results
- Net loss applicable to the common shareholders for the year
ended December 31, 2019 was $117.8 million,
or $(0.70) per share, basic and diluted, compared to net
income applicable to the common shareholders of $137.2
million, or $0.96 per share, basic and diluted, for the
year ended December 31, 2018. Net income in 2018 reflects the
forfeiture and return of all of the Company’s Series 1 preferred
stock held by a former corporate partner and the
relinquishment of Ziopharm’s obligations under a separate
agreement, accounting for approximately $207 million.
- Research and development expenses were $38.3
million for the year ended December 31, 2019, compared
to $34.1 million for the year ended December 31,
2018. The increase in research and development expenses for the
year ended December 31, 2019 is primarily due to expanded
clinical trial activity.
- General and administrative expenses were $19.5
million for the year ended December 31, 2019, compared
to $19.9 million for the year ended December 31,
2018.
Conference Call and Webcast
Scheduled for today at 4:30 p.m. ET, the conference call can be
accessed by dialing 1-844-309-0618 (U.S. and Canada) or
1-661-378-9465 (international). The passcode for the conference
call is 6773016. To access the live webcast or the subsequent
archived recording, 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 two weeks.
About Ziopharm Oncology, Inc.
Ziopharm Oncology is an immuno-oncology company focused on
developing end-to-end cost-effective solutions using its non-viral
Sleeping Beauty platform for T-cell receptor (TCR) and chimeric
antigen receptor (CAR) T-cell therapies and immune-stimulating gene
therapy with Controlled interleukin 12 (IL-12). The Sleeping Beauty
platform genetically modifies T cells with DNA plasmids to express
TCRs to target neoantigens inside and outside hotspots for solid
tumors and CAR to target CD19 for blood cancers using the Company’s
“Rapid Personalized Manufacturing” to produce and release CAR-T as
soon as the day after gene transfer. The Sleeping Beauty platform
is being advanced in collaboration with the National Cancer
Institute, The University of Texas MD Anderson Cancer Center and
Eden BioCell. The Company is also developing its Controlled IL-12
platform, or Ad-RTS-hIL-12 plus veledimex, as monotherapy and in
combination with immune checkpoint inhibitors to treat brain
cancer, including in collaboration with Regeneron
Pharmaceuticals.
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 cash resources, the progress
and timing of the Company's research and development programs,
including the anticipated dates for the initiation, completion and
readouts of its clinical trials and the Company’s expectations
regarding the number of 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 our operating
plans that may impact our 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 Annual Report on 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.
Ziopharm Contact: Chris Taylor VP, Investor Relations and
Corporate Communications T: 617.502.1881 E:
ctaylor@ziopharm.com
− Financial Tables Follow
−
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) |
|
(audited) |
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue |
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
146 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
10,216 |
|
|
|
8,199 |
|
|
|
38,331 |
|
|
|
34,134 |
|
General and administrative |
|
5,820 |
|
|
|
4,563 |
|
|
|
19,527 |
|
|
|
19,918 |
|
Total operating expenses |
|
16,036 |
|
|
|
12,762 |
|
|
|
57,858 |
|
|
|
54,052 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(16,036 |
) |
|
|
(12,762 |
) |
|
|
(57,858 |
) |
|
|
(53,906 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net |
|
290 |
|
|
|
168 |
|
|
|
813 |
|
|
|
631 |
|
Change in fair value of derivative liabilities |
|
- |
|
|
|
113 |
|
|
|
- |
|
|
|
158 |
|
Noncash inducement warrant expense |
|
- |
|
|
|
- |
|
|
|
(60,751 |
) |
|
|
- |
|
Net loss |
|
(15,746 |
) |
|
|
(12,481 |
) |
|
|
(117,796 |
) |
|
|
(53,117 |
) |
Preferred stock dividends |
|
- |
|
|
|
(342 |
) |
|
|
- |
|
|
|
(16,998 |
) |
Settlement of a related party relationship |
|
- |
|
|
|
207,361 |
|
|
|
- |
|
|
|
207,361 |
|
Net Income (loss) applicable to common stockholders |
$ |
(15,746 |
) |
|
$ |
194,538 |
|
|
$ |
(117,796 |
) |
|
$ |
137,246 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
(loss) per share - basic |
$ |
(0.09 |
) |
|
$ |
1.29 |
|
|
$ |
(0.70 |
) |
|
$ |
0.96 |
|
Net income
(loss) per share - diluted |
$ |
(0.09 |
) |
|
$ |
1.29 |
|
|
$ |
(0.70 |
) |
|
$ |
0.96 |
|
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding used |
|
|
|
|
|
|
|
to compute basic net income (loss) per share |
|
179,522,225 |
|
|
|
150,893,470 |
|
|
|
167,952,114 |
|
|
|
143,508,674 |
|
Weighted
average common shares outstanding used |
|
|
|
|
|
|
|
to compute diluted net income (loss) per share |
|
179,522,225 |
|
|
|
151,094,956 |
|
|
|
167,952,114 |
|
|
|
143,710,160 |
|
|
|
|
|
|
|
|
|
ZIOPHARM
Oncology, Inc. |
Balance
Sheet Data |
(in
thousands) |
|
|
|
|
|
|
|
December
31, |
|
|
2019 |
|
2018 |
|
|
|
|
|
Cash and
cash equivalents |
|
79,741 |
|
61,729 |
Working
capital |
|
92,966 |
|
74,802 |
Total
assets |
|
109,114 |
|
95,051 |
Total
stockholders' equity |
|
95,010 |
|
85,564 |
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