Ziopharm Oncology Reports First Quarter 2018 Financial Results and Provides Corporate Update
- Expanding Controlled IL-12 platform to explore additional tumor types
- Cash runway extended to 2Q 2019 with changes to Controlled IL-12 development plans
- ASCO poster to detail IL-12 data in breast cancer, glioblastoma, highlight potential for combination with checkpoint inhibitors
- Sleeping Beauty CAR-T cells manufactured in two days entering clinic in 2H
- Company to host conference call today at
“The landscapes of CAR-T therapies and the use of cytokines are playing out as anticipated,” said
Dr. Cooper continued, “Immune-stimulatory cytokines have gained significant momentum as potential combination therapies with immune checkpoint inhibitors. We are excited to build on our Controlled IL-12 platform and its ability to turn cold tumors hot as we explore more tumor types that can benefit from our ability to regulate IL-12.”
Ziopharm is advancing Ad-RTS-hIL-12 plus veledimex as a gene therapy to treat patients with recurrent glioblastoma (rGBM) as a monotherapy and in combination with an immune checkpoint inhibitor. Ad-RTS-hIL-12 plus veledimex is an adenoviral vector (Ad) administered via a single injection into the tumor and engineered to express human IL-12 (hIL-12), a powerful cytokine that has demonstrated a targeted, anti-tumor immune response with the ability to activate and recruit killer T cells to the tumor site. The expression of hIL-12 is controlled and modulated with the RheoSwitch Therapeutic System® (RTS®) by the small molecule veledimex, an activator ligand which is taken by mouth and crosses the blood-brain barrier.
The Company today announced that it is focusing its resources on studies of Controlled IL-12 in additional tumor types to demonstrate the value of this platform technology and, as a result, the Company is pausing plans for the pivotal trial in rGBM.
Combination Trial with OPDIVO® (nivolumab) in rGBM Initiated. Ziopharm has initiated a trial of adult patients with rGBM to evaluate a single dose of Ad-RTS-hIL-12 plus daily veledimex for 15 days in combination with OPDIVO® (nivolumab), an immune checkpoint inhibitor targeting programmed death-1 (PD-1). In January, the protocol for this first-ever dosing combination was finalized with the
Additional Oncology Indications to be Explored Including in Combination with Immune Checkpoint Inhibitors. The Company previously has presented compelling data demonstrating that Ad-RTS-hIL-12 plus veledimex can turn cold tumors hot by recruiting and activating a sustained immune response that favorably changes the tumor microenvironment in different tumor types. Therefore, Ziopharm plans to explore the potential of the Controlled IL-12 platform by combining it with immune checkpoint inhibitors in multiple tumor types in addition to rGBM later this year.
Pivotal Trial in rGBM Paused. Ziopharm is pausing plans for its pivotal randomized control trial for Ad-RTS-hIL-12 plus 20mg dose of veledimex for the treatment of rGBM. The Company is progressing in resolving previously disclosed technical requirements related to Chemistry and Manufacturing Control (CMC), making this asset phase-3 ready for rGBM.
Expansion Substudy Added to Phase 1 Trial in rGBM. Ziopharm is initiating an expansion substudy in its Phase 1 trial to evaluate Ad-RTS-hIL-12 plus veledimex as a monotherapy to treat patients with rGBM. The Company is adding patients who have not received steroids for four weeks prior and have not been treated with bevacizumab for their disease to the cohort receiving a 20mg dose of veledimex. Previously, the Company has shown improvement in survival benefit in patients who received Ad-RTS-hIL-12 plus 20mg of veledimex with no steroids or low-dose steroids. The data from these patients will help further understand the benefits of IL-12 as a single-agent.
Phase 1 for Pediatric Tumors Ongoing. Ziopharm is enrolling pediatric patients in its Phase 1 trial of Ad-RTS-hIL-12 with veledimex for the treatment of brain tumors at multiple U.S. sites.
Sleeping Beauty and Adoptive Cell Therapies
Using Ziopharm’s non-viral approach leveraging Sleeping Beauty platform to genetically modify cells, the Company is developing chimeric antigen receptor (CAR) T-cell (CAR-T) and T-cell receptor (TCR) T-cell (TCR-T) therapies. These programs are being advanced in collaboration with
Phase 1 Trial of Sleeping Beauty-Modified TCRs to Treat Solid Tumors Expected to Initiate in Second Half of 2018. The NCI expects to initiate a Phase 1 trial in the second half of 2018 to evaluate adoptive cell transfer-based immunotherapies genetically modified using the Sleeping Beauty platform to express TCRs for the treatment of solid tumors. Ziopharm,
Phase 1 Trial of CD33-specific CAR+ T Therapy for Acute Myeloid Leukemia (AML). Enrollment is underway at MD Anderson in the Phase 1 adoptive cellular therapy clinical trial of CAR+ T-cell therapy in patients with refractory/recurrent AML that express CD33. This trial infuses autologous T cells genetically modified with lentivirus to express a CD33-specific CAR and a kill switch for elimination of genetically modified cells. Data from this trial are expected to serve as the basis for evaluating CD33 as a potential target for further development using non-viral manufacturing of T cells with Ziopharm’s point-of-care technology.
First-Quarter 2018 Financial Results
- Net loss applicable to the common shareholders for the first quarter of 2018 was
$21.1 million, or $(0.15)per share, compared to a net loss of $19.7 million, or $(0.15)per share, for the first quarter of 2017. The increased net loss is primarily due to a decrease in revenue recognized related to the implementation of ASU 2014-09 and an increase in operating expenses.
- Research and development expenses were
$10.2 millionfor the first quarter of 2018, compared to $12.0 millionfor the first quarter of 2017. The decrease in research and development expenses for the three months ended March 31, 2018is primarily due to decreased manufacturing and preclinical activity related to our cell and gene therapy programs, as our trials prepare to be moved forward in the clinic.
- General and administrative expenses were
$6.2 millionfor the first quarter of 2018, compared to $3.6 millionfor the first quarter of 2017. The increase in general and administrative expenses for the three months ended March 31, 2018is primarily due to severance and non-cash stock compensation expense.
- The Company ended the quarter with unrestricted cash resources of approximately
- In addition, a prepayment of approximately
$32.4 millionremains for programs to be conducted by the Company at MD Anderson Cancer Centerunder the current Research and Development Agreement.
- The Company believes its current resources will be sufficient to fund its currently planned operations into the second quarter of 2019.
Conference Call and Slide Webcast
Ziopharm will host a webcast and conference call today,
This press release contains certain forward-looking statements within the meaning of 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 Company's ability to establish a commercially-viable manufacturing approach as well as the progress and timing of the development of the Company's research and development programs, including its potential initiation of a first in-human trial using its P-O-C manufacturing process and the timing for the initiation of its clinical trials. All 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: changes in the Company's financial condition and cash needs, funding or other strategic opportunities that become available to the Company, the Company's ability to finance its 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 other product candidates will advance further in the preclinical research or clinical trial process and whether and when, if at all, they will receive final approval from the
|Ziopharm Oncology, Inc.
Statements of Operations
(in $ thousands except share and per share data)
|Three Months Ended March 31|
|Research & Development||$10,183||$11,967|
|General and Administrative||$6,159||$3,595|
|Total operating expenses||$16,342||$15,562|
|Loss from operations||($16,196||)||($13,965||)|
|Other income (expense), net||$148||$38|
|Change in fair value of derivative liabilities||$28||($1,560||)|
|Preferred stock dividends||($5,120||)||($4,171||)|
|Net loss applicable to common stockholders||($21,140||)||($19,658||)|
|Basic and diluted net loss per share|
|Weighted average common shares outstanding used to compute basic and diluted net loss per share||140,853,120||130,696,400|
|Ziopharm Oncology, Inc.
Balance Sheet Data
|March 31, 2018||December 31, 2018|
|Cash and cash equivalents||$51,108||$70,946|
|Total stockholders' (deficit)||($123,149||)||($96,806||)|
Source: ZIOPHARM Oncology Inc