- Company to Webcast Corporate Update
Thursday, February 23, at the 2017 RBC Global Healthcare Conference
-
ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company
focused on new immunotherapies, today announced financial results
for the fourth quarter ended December 31, 2016, and provided an
update on the Company's recent activities.
“ZIOPHARM made significant progress over the
course of 2016, putting us on track to enter a pivotal study and
prosecute multiple high-value studies across our oncology programs
in 2017, focusing on gene therapy, CAR and TCR T-cell therapies, as
well as off-the-shelf NK cells,” said Laurence Cooper, M.D., Ph.D.,
Chief Executive Officer of ZIOPHARM. “This strategy moves us not
just into a registration pathway with Ad-RTS-hIL-12 + veledimex,
but clinically validates the broad potential of our technologies,
including our switch systems and the Sleeping Beauty non-viral
platform. These advances will be applied across our program areas,
enabling us to increase control, reduce complexity, and manage
costs, addressing some of the most significant needs in gene and
cell therapy. Ultimately, the ability to deliver controlled,
point-of-care therapy makes individualized treatment targeting each
patient’s tumor neoantigens possible, a goal with profound clinical
implications.”
Francois Lebel, M.D., Executive Vice President,
Research and Development, Chief Medical Officer at ZIOPHARM, added:
“In a recently updated presentation of results from our Phase 1,
multi-center study of Ad-RTS-hIL-12 + veledimex in patients with
recurrent high-grade gliomas, we observed a median overall survival
of 12.7 months in the 20mg veledimex dose group. This remains a
very encouraging outcome compared to historic controls. We look
forward to providing an update on our registration pathway in this
indication in the first quarter, and to initiating a pivotal study
by the end of 2017.”
Program Updates
Ad-RTS-IL-12 + veledimex
Ad-RTS-hIL-12 + veledimex is a gene therapy
candidate for the controlled expression of interleukin 12 (IL-12),
a critical protein for stimulating an anti-cancer immune response,
using the RheoSwitch Therapeutic System® (RTS®) gene switch.
ZIOPHARM is currently conducting a multi-center Phase 1 study of
Ad-RTS-hIL-12 + orally-administered veledimex in patients with
recurrent or progressive glioblastoma multiforme (GBM), an
aggressive form of brain cancer.
- Announced End-of-Phase 2 Meeting with the FDA.
In its presentation at the 35th Annual J.P. Morgan Healthcare
Conference, the Company announced that it was granted an
end-of-Phase 2 meeting with the U.S. Food and Drug Administration
(FDA) to determine a pivotal trial design for Ad-RTS-hIL-12 +
veledimex for recurrent GBM. The Company expects to announce the
outcome of this meeting in the first quarter of 2017, with the goal
of initiating a pivotal clinical trial of Ad-RTS-hIL-12 + veledimex
in recurrent GBM in 2017.
- Presented Data Demonstrating Survival Benefits in
Patients with Recurrent Brain Cancer Treated with Ad-RTS-hIL-12 +
Veledimex. In November 2016, ZIOPHARM presented clinical
data for Ad-RTS-hIL-12 + veledimex for recurrent brain cancer at
the 21st Annual Scientific Meeting of the Society for
Neuro-Oncology (SNO) in Scottsdale, Arizona. In the study,
recombinant IL‑12, leading to the body’s production of
interferon-gamma (IFN-gamma), were measured in the bloodstream and
found to be proportional to the three doses of veledimex (20mg,
n=7; 30mg, n=4; and 40mg, n=6), demonstrating that this
orally-delivered activator crossed the blood-brain barrier to
engage the RTS® gene switch and express IL-12 and IFN-gamma in a
dose-dependent manner. Toxicities were consistent with those
previously reported and all related side effects were reversed upon
cessation of veledimex. Based on tolerability and survival benefit
(median OS=12.7 months, n=15, as of January 6, 2017), 20 mg was
selected for an expansion cohort, with patients being followed for
overall survival. Updated results from the study have been
submitted for presentation at an upcoming scientific meeting.
- Presented Results of Pre-Clinical Study Supporting
Initiation of New Clinical Trial of Ad-RTS-hIL-12 + Veledimex in
Pediatric Brain Tumors. In November 2016, ZIOPHARM
presented results from a preclinical study of Ad-RTS-mIL-12 +
veledimex as an investigational therapy for pediatric glioma in a
poster titled "Local regulated IL-12 expression as an immunotherapy
for the treatment of pontine glioma" at the 21st Annual Scientific
Meeting of the SNO in Scottsdale, Arizona. In an orthotopic pons
model, veledimex was shown to cross the blood-brain barrier to
control mouse IL-12 production from the tumor, which stimulated the
immune system and resulted in increased overall survival. Based on
these results, the Company plans to initiate a Phase 1 clinical
trial in pediatric brain tumors, including diffuse intrinsic
pontine glioma (DIPG) in 2017.
- Presented Data Demonstrating Activation of Anti-Tumor
Immune Response Using Ad-RTS-hIL-12 + Veledimex in Patients with
Advanced Breast Cancer. In October 2016, ZIOPHARM
announced the presentation of preliminary data from the Company's
Phase 1b/2 study of Ad-RTS-hIL-12 + veledimex following standard
chemotherapy for the treatment of patients with locally advanced or
metastatic breast cancer at the European Society for Medical
Oncology (ESMO) 2016 Congress in Copenhagen, Denmark. Results
showed that Ad-RTS-hIL-12 + seven days of veledimex consistently
elicited production of IL-12 which in turn produced IFN-gamma. It
was notable that the influx of CD8+ T cells making IFN-gamma within
the tumor were present five weeks after completion of veledimex,
consistent with the ability of Ad-RTS-hIL-12 to favorably impact
the tumor environment over the long term. In two patients,
Ad-RTS-hIL-12 + veledimex provided a meaningful chemotherapy
holiday, with durable responses for 18 and 35 weeks.
Adoptive Cell Therapies
ZIOPHARM is developing various immuno-oncology
programs, including chimeric antigen receptor (CAR) T cell (CAR-T),
T-cell receptor (TCR) T cell (TCR-T), and natural killer (NK)
adoptive cell-based therapies. These programs are being advanced in
collaboration with Intrexon Corporation (NYSE:XON), MD Anderson
Cancer Center, and Merck Serono, the biopharmaceutical business of
Merck KGaA (CAR-T only).
- Announced Advances in Point-of-Care Approach for
Rapidly Producing CAR-Expressing T Cells Utilizing the Sleeping
Beauty System. In January 2017, ZIOPHARM
announced improved production times utilizing its non-viral
platform to engineer T cells in an ongoing Phase 1 study of
second-generation Sleeping Beauty (SB) CD19-specific CAR+ T cells.
Plans to progress the Company's point-of-care (POC) approach with
administration of CAR-T cell therapy in less than 2 days are also
underway, helping expand access to innovative T-cell
therapies.
- Cooperative Research and Development Agreement with the
National Cancer Institute Utilizing Sleeping Beauty System to
Generate T cells Targeting Neoantigens. In January 2017,
ZIOPHARM and partner Intrexon announced the signing of a
Cooperative Research and Development Agreement (CRADA) with the
National Cancer Institute (NCI) for the development of adoptive
cell transfer-based immunotherapies genetically modified using the
SB system to express TCRs for the treatment of solid tumors.
Research conducted under the CRADA will be at the direction of
Steven A. Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at
the NCI’s Center for Cancer Research.
- Results from Four Studies of Adoptive Cell-based
Therapeutic Programs Presented at the 2016 American Society of
Hematology Annual Meeting. In December 2016, ZIOPHARM
presented data from the Company's adoptive cell-based therapeutic
programs at the 58th American Society of Hematology Annual Meeting
and Exposition held December 3-6, 2016 in San Diego. The research,
conducted at the MD Anderson Cancer Center and Intrexon,
demonstrates, among other results, that T cells can be very rapidly
produced with the SB system and that a non-viral approach to gene
therapy can be harnessed to generate CAR- and TCR-expressing
effector cells.
- Announced Publication Demonstrating Membrane-bound
IL-15 (mbIL15) Enhanced Persistence of
CD19-Specific T Cells. In November 2016, ZIOPHARM
announced the publication of data demonstrating enhanced
persistence of genetically modified T cells targeting leukemia
through utilization of its non-viral SB system to co-express mbIL15
and a CD19-specific CAR. The article, titled "Tethered IL-15
augments antitumor activity and promotes a stem-cell memory subset
in tumor-specific T cells," was published in the Proceedings of the
National Academy of Sciences and is available online here.Using the
SB system, researchers generated genetically modified T cells that
preserved stem-cell memory (TSCM) cells by co-expressing the CAR
with mbIL15. Engineered T cells were effective in treating
established CD19+ leukemia in mice by facilitating the long-term
persistence of TSCM cells sustained by signaling through
recombinant IL-15. These findings provide for a translational
pipeline of immunotherapies with improved potential by combining
mbIL15 and T cells with diverse specificities.The Company
previously announced the publication of data highlighting the
benefits of using the non-viral SB system to genetically modify T
cells to express a CAR for use against CD19-expressing leukemias
and lymphomas. The article, titled "Phase I trials using Sleeping
Beauty to generate CD19-specific CAR T cells," was published in the
Journal of Clinical Investigation (doi:10.1172/JCI86721), and
is available online here.
Anticipated 2017 Milestones
- Intra-tumoral IL-12 RheoSwitch® programs:- Clinical data from
Phase 1 of Ad-RTS-hIL-12 + veledimex for GBM to be presented at a
scientific meeting in 2017- Initiate pivotal clinical trial for GBM
in 2017- Initiate combination study of Ad-RTS-hIL-12 + veledimex
with immune checkpoint inhibitor (PD-1) during the first half of
2017- Initiate Phase 1 study in the treatment of brain tumors in
children during the first half of 2017
- CAR-T programs:- Continue CD19-specific CAR+ T clinical study
in 2017 enrolling patients under shortened manufacturing process
towards point of care- Initiate a CD33-specific CAR+ T clinical
study for relapsed or refractory AML in 2017- Advance CAR+ T-cell
preclinical studies for at least one hematological malignancy under
a shortened manufacturing process towards point of care
- TCR-T programs:- Execute CRADA with NCI utilizing SB to
generate T cells targeting neoantigens
- NK cell programs:- Initiate a Phase 1 study of off the shelf NK
cells for AML in 2017
- GvHD programs:- Advance preclinical studies in 2017
2017 RBC Global Healthcare Conference
The Company also announced that Dr. Cooper will
present at the 2017 RBC Global Healthcare Conference on Thursday,
February 23rd, 2017 at 1:35 p.m. ET. The conference will be held at
the Lotte New York Palace in New York City.
To access a live audio webcast of the
presentation, please visit the Investor Relations section at
www.ziopharm.com.
Fourth-Quarter 2016 Financial Results
- Net loss applicable to common shareholders for the fourth
quarter of 2016 was $14.8 million, or $(0.11) per share, compared
to a net loss of $9.5 million, or $(0.07) per share, for the fourth
quarter of 2015. The increase in net loss for the three months
ended December 31, 2016 is primarily due to a $1.2 million increase
in expenses related to the gene therapy and cell therapy programs,
decreased collaboration revenue of $0.3 million, an increase in the
charge for the change in derivative liabilities of $0.1 million and
income attributable to preferred stockholders of $3.5 million.
- Research and development expenses were $9.4 million for the
fourth quarter of 2016 compared to $8.1 million for the fourth
quarter of 2015. The increase in research and development expenses
for the three months ended December 31, 2016 is primarily due to a
$1.2 million increase in expenses related to the gene therapy and
cell therapy programs.
- General and administrative expenses were $3.3 million for the
fourth quarter of 2016 and 2015.
The Company ended the quarter with cash and cash
equivalents of approximately $81.1 million, which the Company
believes will be sufficient to fund its currently planned
activities into the fourth quarter of 2017. The cash burn is
expected to increase substantially during 2017 due to the
anticipated initiation of a pivotal trial in GBM.
About ZIOPHARM Oncology,
Inc.:
ZIOPHARM Oncology is a Boston,
Massachusetts-based biotechnology company employing novel gene
expression, control and cell technologies to deliver safe,
effective and scalable cell- and viral-based therapies for the
treatment of cancer and graft-versus-host-disease. The Company's
immuno-oncology programs, in collaboration with Intrexon
Corporation (NYSE:XON) and the MD Anderson Cancer Center, include
chimeric antigen receptor T cell (CAR-T) and other adoptive
cell-based approaches that use non-viral gene transfer methods for
broad scalability. The Company is advancing programs in multiple
stages of development together with Intrexon Corporation's
RheoSwitch Therapeutic System® technology, a switch to turn on and
off, and precisely modulate, gene expression in order to improve
therapeutic index. The Company's pipeline includes a number of
cell-based therapeutics in both clinical and preclinical testing
which are focused on hematologic and solid tumor malignancies.
Forward-Looking Safe-Harbor
Statement:
This press release contains certain
forward-looking information about ZIOPHARM Oncology, Inc. that is
intended to be covered by the safe harbor for "forward-looking
statements" provided by 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 plans and
expectations regarding its securities offerings, fundraising
activities and financial strategy, the progress, timing and results
of preclinical and clinical trials involving the Company's drug
candidates, and the progress of the Company's research and
development programs. All of such statements are subject to certain
risks and uncertainties, many of which are difficult to predict and
generally beyond the control of the Company, that could cause
actual results to differ materially from those expressed in, or
implied by, the forward-looking statements. These risks and
uncertainties include, but are not limited to: our ability to
finance our operations and business initiatives and obtain funding
for such activities, whether chimeric antigen receptor T cell (CAR
T) approaches, Ad-RTS-hIL-12, TCR and NK cell-based therapies, or
any of our other therapeutic candidates will advance further in the
pre-clinical or clinical trials process and whether and when, if at
all, they will receive final approval from the U.S. Food and Drug
Administration or equivalent foreign regulatory agencies and for
which indications; whether chimeric antigen receptor T cell (CAR T)
approaches, Ad-RTS-hIL-12, TCR and NK cell-based therapies, and our
other therapeutic products will be successfully marketed if
approved; the strength and enforceability of our intellectual
property rights; competition from other pharmaceutical and
biotechnology companies; and the other risk factors contained in
our periodic and interim SEC reports filed from time to time with
the Securities and Exchange Commission, including but not limited
to, our Annual Report on Form 10-K for the fiscal year ended
December 31, 2016. Readers are cautioned not to place undue
reliance on these forward-looking statements that speak only as of
the date hereof, and we do not undertake any obligation to revise
and disseminate forward-looking statements to reflect events or
circumstances after the date hereof, or to reflect the occurrence
of or non-occurrence of any events.
TrademarksRheoSwitch
Therapeutic System® and RTS® are registered trademarks of Intrexon
Corporation.
|
ZIOPHARM Oncology, Inc. |
Statements of Operations |
(in thousands except share and per share
data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Year Ended |
|
|
December 31, |
|
December 31, |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
|
|
|
|
|
|
Collaboration revenue |
|
$ |
1,597 |
|
|
$ |
1,919 |
|
|
$ |
6,861 |
|
|
$ |
4,332 |
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research
and development, including cost of contracts |
|
|
9,389 |
|
|
|
8,142 |
|
|
|
157,791 |
|
|
|
106,785 |
|
General
and administrative |
|
|
3,319 |
|
|
|
3,259 |
|
|
|
14,377 |
|
|
|
17,647 |
|
Total
operating expenses |
|
|
12,708 |
|
|
|
11,401 |
|
|
|
172,168 |
|
|
|
124,432 |
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(11,111 |
) |
|
|
(9,482 |
) |
|
|
(165,307 |
) |
|
|
(120,100 |
) |
|
|
|
|
|
|
|
|
|
Other
income (expense), net |
|
|
32 |
|
|
|
6 |
|
|
|
134 |
|
|
|
12 |
|
Change in
derivative liabilities |
|
|
(145 |
) |
|
|
- |
|
|
|
(124 |
) |
|
|
- |
|
Net
loss |
|
|
(11,224 |
) |
|
|
(9,476 |
) |
|
$ |
(165,297 |
) |
|
$ |
(120,088 |
) |
Preferred
stock dividends |
|
|
(3,532 |
) |
|
|
- |
|
|
|
(7,123 |
) |
|
|
- |
|
Net loss
applicable to common stockholders |
|
$ |
(14,756 |
) |
|
$ |
(9,476 |
) |
|
$ |
(172,420 |
) |
|
$ |
(120,088 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share |
|
$ |
(0.11 |
) |
|
$ |
(0.07 |
) |
|
$ |
(1.32 |
) |
|
$ |
(0.96 |
) |
|
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding used |
|
|
|
|
|
|
|
|
to
compute basic and diluted net loss per share |
|
|
130,524,204 |
|
|
|
129,879,897 |
|
|
|
130,391,463 |
|
|
|
125,416,084 |
|
|
|
|
|
|
|
|
|
|
ZIOPHARM Oncology, Inc. |
Balance Sheet Data |
(in thousands) |
(unaudited) |
|
|
|
|
|
|
|
December 31, |
|
December 31, |
|
|
2016 |
|
2015 |
|
|
|
|
|
Cash and cash
equivalents |
|
81,053 |
|
|
140,717 |
Working capital |
|
89,075 |
|
|
134,398 |
Total assets |
|
106,348 |
|
|
153,724 |
Total stockholders'
equity (deficit) |
|
(77,298 |
) |
|
87,371 |
|
|
|
|
|
Contact:
Lori Ann Occhiogrosso
ZIOPHARM Oncology, Inc.
617-259-1987
locchiogrosso@ziopharm.com
David Pitts
Argot Partners
212-600-1902
david@argotpartners.com
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