ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) today announced financial
results for the second quarter ended June 30, 2016, and provided an
update on the Company’s recent activities.
"ZIOPHARM had a very productive first half, with
the achievement of pipeline and corporate milestones across the
breath of our portfolio and the advancement of our goal to position
the company at the forefront of those harnessing the immune system
to target cancer," said Laurence Cooper, M.D., Ph.D., Chief
Executive Officer of ZIOPHARM Oncology. "Central to this effort, we
were pleased to have amended the terms of our collaboration with
Intrexon to facilitate the commercialization of our immunotherapy
assets. The benefit of this new structure is expected to be first
realized with our gene therapy Ad-RTS-hIL-12 + veledimex program,
which remains on track to move into a registrational trial in
advanced glioblastoma in 2017.”
Dr. Cooper added: “As we progress through the
remainder of 2016, we will continue to work with our collaborators,
including Intrexon Corporation and the MD Anderson Cancer Center,
to advance new therapies into the clinic. We look forward in 2016
to seeing six clinical trials exploring immuno-oncology approaches
and combinations, in addition to preclinical projects advancing
towards the clinic. As these programs mature, we expect to see
proof-of-concept clinical data that will drive value for all of our
stakeholders.”
Corporate and Program Updates
Corporate
Amended Exclusive Channel Collaborations
with Intrexon to Improve Alignment as Programs Advance through
Development. In June, ZIOPHARM and Intrexon Corporation
(NYSE:XON) announced amendments to their Exclusive Channel
Collaborations (ECCs) in the fields of oncology and
graft-versus-host-disease (GvHD) to improve alignment between both
companies as ZIOPHARM broadens its pipeline and advances multiple
therapeutic programs in the clinic.
Under the terms of the amendments:
- Operating profit rates payable to Intrexon from ZIOPHARM on
products developed under its two existing collaborations will be
reduced from 50% to 20%. This reduction will not apply to royalties
or other payments made with respect to the companies' existing
collaboration with Merck Serono, the biopharmaceutical business of
Merck KGaA;
- Economics from any future sublicensing arrangements with
potential third party collaborators will remain evenly split.
In consideration of the amendments, ZIOPHARM has
issued shares of a new class of preferred stock that carries an
initial stated value of $120 million and a monthly dividend of 1%,
payable in additional preferred shares. Only upon the first
approval of a product in the United States or upon certain
fundamental transactions, such as a change of control of ZIOPHARM,
the preferred shares issued to Intrexon will be converted into
ZIOPHARM common stock equal to the aggregate stated value divided
by the volume weighted average closing price of ZIOPHARM's common
stock over the 20 trading days ending on the date that the product
approval or such transaction is announced.
Gene Therapies
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 enrolling patients in two studies of
Ad-RTS-hIL-12 + veledimex: a multi-center Phase 1 study in patients
with recurrent or progressive glioblastoma multiforme (GBM), an
aggressive form of brain cancer, and a Phase 1b/2 study for the
treatment of patients with locally advanced or metastatic breast
cancer following standard chemotherapy.
- Presented Clinical Data Highlighting Favorable Interim
Survival Results in Phase 1 Study of Ad-RTS-hIL-12 + Veledimex in
Brain Cancer. ZIOPHARM presented data from its Phase 1,
multi-center dose-escalation study of patients with recurrent
high-grade gliomas at the 2016 American Society of Clinical
Oncology (ASCO) Annual Meeting held June 3-7, 2016 in Chicago and
updated at an American Society of Hematology Workshop on Genome
Editing in Washington D.C. on July 14, 2016. These data demonstrate
promising early activity in this medically fragile patient
population, with a median overall survival that has not been
reached with 11 of 14 patients alive and in follow up, and a median
follow up of 8 months with 6 patients out of 7 patients alive in
the study’s first dose cohort (20mg veledimex). The study also
showed that IL-12 in the bloodstream was found to be proportional
to the amount of veledimex administered, demonstrating that this
orally-delivered activator crossed the blood brain barrier to
activate the IL-12 gene programming deposited in the tumor and
turned on the RheoSwitch® technology in a dose-dependent manner. In
June, ZIOPHARM announced the successful completion of enrollment in
the first and second dosing cohorts (40mg veledimex) of the study,
as well as the initiation of enrollment in a third cohort (30mg
veledimex).
- Preclinical Studies Combining Ad-RTS-IL-12 + Veledimex
and Immune Checkpoint Inhibitors in Brain Tumor Models Presented at
ASGCT, Combination Study Expected to Initiate in 2016. In
an oral presentation, ZIOPHARM presented data from preclinical
studies of Ad-RTS-IL-12 + veledimex combined with immune checkpoint
inhibitors (iCPI) in glioblastoma (GBM) mouse models at the 2016
Meeting of the American Society of Gene and Cell Therapy (ASGCT),
which took place May 4-7, 2016 in Washington, D.C. Results
demonstrated that survival of mice treated with Ad-RTS-IL-12 +
veledimex and anti-PD-1 therapy was superior to either treatment
alone, with a combination showing 100% survival. Because
Ad-RTS-IL-12 and anti-PD-1 are clinically available, these data
provide impetus for evaluating this combination immunotherapy in
humans. ZIOPHARM plans to initiate a combination study in
2016.
Adoptive Cell Therapies
ZIOPHARM is developing various immuno-oncology
programs, including chimeric antigen receptor T-cell (CAR-T),
T-cell receptor (TCR), and natural killer (NK) adoptive cell-based
therapies. These programs are being advanced in collaboration with
Intrexon, MD Anderson Cancer Center, and Merck Serono (CAR-T
only).
- Announced Plans for Phase I Clinical Trial with CD33
CAR-T Cell Therapy. In July, ZIOPHARM announced plans for
a Phase I adoptive cellular therapy clinical trial utilizing
autologous T cells transduced with lentivirus to express a
CD33-specific chimeric antigen receptor (CAR) in patients with
relapsed or refractory acute myeloid leukemia (AML). The trial is
based on preclinical studies, including in vitro data demonstrating
that lentiviral-transduced CAR-T cells targeting CD33 exhibit
specific killing activity for CD33+ AML cells and a
proof-of-concept study utilizing an in vivo mouse model for AML,
which showed that these CAR-T cells were able to eliminate disease
and significantly enhance survival as compared to control groups.
These positive preclinical results indicate biological activity and
are suggestive of potential therapeutic effect for the treatment of
AML.
- Announced Publication of First-In-Human Trials using
Non-Viral Sleeping Beauty System to Express CD19-Specific CAR in T
cells in Journal of Clinical Investigation. In August,
ZIOPHARM announced the publication of data highlighting the
benefits of using the non-viral Sleeping Beauty (SB) system to
genetically modify T cells to express a chimeric antigen receptor
(CAR) for use against 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.
The paper describes results for 26 patients with
multiply relapsed B-lineage acute lymphoblastic leukemia (ALL,
n=17) or B-cell non-Hodgkin lymphoma, (NHL, n=9) who were enrolled
in two investigator-initiated clinical trials at the University of
Texas MD Anderson Cancer Center infused with SB-modified T cells
after autologous (n=7) or allogeneic (n=19) hematopoietic stem-cell
transplantation (HSCT). Although the primary objective of these
trials was not to establish efficacy, the recipients' outcomes are
encouraging, with apparent doubling of survivals compared to
historical controls which is attributed to the persistence of the
infused T cells. Additionally, by infusing a CD19-specific CAR T
cells to target minimal residual disease after autologous and
allogeneic HSCT, the approach may improve tolerability by avoiding
cytokine storm.
Milestones ZIOPHARM achieved and expects the
following milestones to occur in 2016:
- Intra-tumoral IL-12 RheoSwitch® programs:
- Clinical update presented from the Company’s Phase 1 study of
GBM at the Annual Meeting of the American Society of Clinical
Oncology
- Update on Phase 1/2 study in Breast Cancer with standard of
care presented at ASCO
- Pre-clinical data presented at the American Society of Cell and
Gene Therapy (ASGCT) Annual Meeting for combining with checkpoint
inhibitor therapy (anti PD-1)
- Initiate combination study of Ad-RTS-hIL-12 with anti PD-1
- CAR+ T programs:
- Continuation of second generation CD19 CAR+ T clinical
study
- Initiate a CAR+ T clinical study for CD33
- Preclinical data presented at ASGCT for shortening the time of
ex vivo manufacture of SB-modified T cells
- Initiate CAR+ T-cell preclinical studies for other
hematological malignancies and solid tumors
- TCR-T programs
- Initiate TCR-modified T-cell preclinical studies
- NK cell programs
- Initiate a Phase 1 study of off-the-shelf NK cells for AML
- GvHD programs
- Initiate preclinical studies
- Pediatric programs
- Pre-clinical data to be presented in the fall with
intra-tumoral IL-12 under RheoSwitch® control for brain tumor
The Company is also evaluating additional potential
preclinical candidates and continuing discovery efforts aimed at
identifying other potential product candidates under its Exclusive
Channel Agreement with Intrexon. In addition, the Company may seek
to enhance its pipeline in immuno-oncology through focused
strategic transactions, which may include acquisitions,
partnerships and in-licensing activities.
Conference Call
ZIOPHARM will host a conference call and webcast
slide presentation today, August 9, 2016, at 4:30 pm ET. The call
can be accessed by dialing 1-844-309-0618 (U.S. and Canada) or
661-378-9465 (international). The passcode for the conference call
is 58685274. To access the slide and live audio webcast, or the
subsequent archived recording, visit the "Investors & Media"
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 (2) weeks.
Second-Quarter 2016 Financial
Results
- Net loss for the second quarter of 2016 was $131.2 million, or
$(1.01) per share, compared to a net loss of $14.2 million, or
$(0.11) per share, for the second quarter of 2015. The primary
driver of the increase was the amendments to the Company’s
Exclusive Channel Collaborations in the fields of oncology and
graft-versus-host-disease disclosed above. The Company
recorded a non-cash charge of $119.1 million, or $(0.91) per share
for the fair value of the Series 1 preferred stock that was issued
on July 1, 2016. Additionally, the Company recognized
approximately $1.7 million in revenue during the quarter in
comparison with $0.3 million in revenue in 2015 as a result of
revenue recognized under the Ares Trading Agreement.
- Research and development expenses were $129.2 million for the
second quarter of 2016 compared to $7.4 million for the second
quarter of 2015. The increase in research and development expenses
for the quarter is primarily due to the non-cash charge of $119.1
million for the fair value of the Series 1 preferred stock that was
issued on July 1, 2016.
- General and administrative expenses were $3.7 million for the
second quarter of 2016 compared to $7.1 million for the second
quarter of 2015. The decrease was primarily due to a reduction in
employee related costs in 2016.
- The Company ended the quarter with cash and cash equivalents of
approximately $109.0 million, which the Company believes will be
sufficient to fund its currently planned activities into the fourth
quarter of 2017.
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. 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, 2015, and our Quarterly Report for the quarter ended
June 30, 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.
Trademarks
RheoSwitch Therapeutic System® and RTS® technology
are registered trademarks of Intrexon Corporation.
ZIOPHARM Oncology, Inc. |
Condensed Statements of
Operations |
(in thousands except share and per share
data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
June 30, |
|
|
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
|
|
|
|
|
Revenue |
|
|
|
|
$ |
1,697 |
|
|
$ |
272 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and
development, including cost of contracts |
|
|
|
|
129,228 |
|
|
|
7,424 |
|
General and administrative |
|
|
|
|
|
3,711 |
|
|
|
7,073 |
|
Total operating expenses |
|
|
|
|
|
132,939 |
|
|
|
14,497 |
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
|
|
|
(131,242 |
) |
|
|
(14,225 |
) |
|
|
|
|
|
|
|
|
Other income (expense), net |
|
|
|
|
|
42 |
|
|
|
14 |
|
Net loss |
|
|
|
|
$ |
(131,200 |
) |
|
$ |
(14,211 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share |
|
|
|
|
$ |
(1.01 |
) |
|
$ |
(0.11 |
) |
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding used |
|
|
|
|
|
|
to compute basic and diluted net loss per share |
|
|
|
|
130,385,077 |
|
|
|
128,413,417 |
|
|
|
|
|
|
|
|
|
ZIOPHARM Oncology, Inc. |
|
Balance Sheet Data |
|
(in thousands) |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
|
|
2016 |
|
|
2015 |
|
|
|
|
|
|
|
Cash and cash
equivalents |
|
|
109,004 |
|
|
140,717 |
|
Working capital |
|
|
110,674 |
|
|
134,398 |
|
Total assets |
|
|
128,012 |
|
|
153,724 |
|
Total stockholders'
equity (deficit) |
|
|
(51,990 |
) |
|
87,371 |
|
|
|
|
|
|
|
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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