Ziopharm Oncology Reports Second Quarter 2018 Financial Results and Provides Corporate Update
Company Focused on Responding to
NCI to file IND for Sleeping Beauty Manufactured TCR-T Cell Therapies Targeting Neoantigens in 4Q2018
Controlled IL-12 Monotherapy, Combination Studies Advancing
Changes to Board of Directors and New Staff Illustrate Company Growth Plans
Company to Host Conference Call Today at
“Our Controlled IL-12 and Sleeping Beauty platforms address the major problems in immuno-oncology which are targeting solid tumors and reducing the costs and complexities of T-cell therapies,” said
Dr. Cooper continued, “The team at the
Dr. Cooper added, “Our trials underway using the RheoSwitch® gene switch within Ad-RTS-hIL-12 are evaluating the control of IL-12 as monotherapy and in combination with an immune checkpoint inhibitor in patients with recurrent glioblastoma. We are in advanced discussions with partners that we believe will validate and enhance our approach to brain cancer and additional solid tumors. Lastly, I am delighted to be working with the Board to institute changes to enable Ziopharm to leverage our platforms to solve problems and realize the potential of immunotherapy.”
Sleeping Beauty and T-cell Therapies
Using the Sleeping Beauty platform to genetically modify cells, the Company is testing 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
Status of IND Application for Phase 1 Trial to Evaluate CD19-targeted CAR-T Therapy: The Company together with its partners at
Phase 1 Trial of CD19-specific CAR+ T Therapy for B-cell Lymphoid Malignancies: Enrollment and treatment of patients is ongoing at MD Anderson in the second-generation Phase 1 investigator-initiated clinical trial of CAR+ T-cell therapy in patients with refractory leukemias and lymphomas that express CD19. This trial infuses autologous T cells genetically modified with the Sleeping Beauty system to express a CD19-specific CAR. Data from this clinical trial showing continued anti-tumor effects will advance understanding of T-cell dosing, CAR design, reducing the time to manufacture T cells and release criteria.
Phase 1 Trial of Sleeping Beauty-Modified TCRs to Treat Solid Tumors Expected to Initiate in Fourth Quarter of 2018: Ziopharm, Precigen and the NCI are collaborating under a
Phase 1 Trial of CD33-specific CAR+ T Therapy for Acute Myeloid Leukemia (AML): Enrollment and treatment of patients is ongoing at MD Anderson in the Phase 1 investigator-initiated 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 target for further development using non-viral manufacturing of T cells with Ziopharm’s point-of-care technology. The Company expects to decide by the end of this year whether or not to transition this CD33-targeted CAR-T therapy to the Sleeping Beauty platform.
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 is a replication-incompetent adenoviral vector (Ad) administered via a single injection into the tumor and engineered to conditionally express human interleukin-12 (hIL-12), an immune-stimulatory cytokine that has a demonstrated ability to activate and recruit killer T cells to tumor sites. The expression of hIL-12 is controlled and modulated via the RheoSwitch Therapeutic System® (RTS®) by the small molecule veledimex, an activator ligand which is taken by mouth and crosses the blood-brain barrier. In addition to rGBM, the Company is evaluating Ad-RTS-hIL-12 plus veledimex in additional tumor types in combination with immune checkpoint inhibitors.
First Patient Treated in Combination Trial with OPDIVO® (nivolumab) in rGBM Initiated: Ziopharm announced in June that it treated the first patient in its Phase 1 trial of adult patients with rGBM to evaluate a single dose of Ad-RTS-hIL-12 plus daily veledimex in combination with OPDIVO® (nivolumab), an immune checkpoint inhibitor targeting programmed death-1 (PD-1). The Company expects to enroll up to 18 patients with rGBM in this single-arm study to evaluate the safety and tolerability of this combination regimen, establish optimal dosing of veledimex and nivolumab, and measure overall patient survival. This trial is being conducted at multiple leading brain cancer centers in
Expansion Substudy Added to Phase 1 Trial in rGBM: Ziopharm initiated an expansion substudy in its Phase 1 trial to evaluate Ad-RTS-hIL-12 plus veledimex as a monotherapy to treat up to 25 patients with rGBM. The Company is adding patients who have not received steroids for four weeks prior to and have not been treated with bevacizumab for their disease to a new cohort receiving a 20mg dose of veledimex. Previously, the Company has shown improvement in survival in patients who received a single injection of Ad-RTS-hIL-12 plus 20mg daily dosing of veledimex. The data from this multi-center U.S. trial 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.
Clinical Data from Breast Cancer and Glioblastoma Studies Presented at
Ziopharm this week announced changes to its Board of Directors.
The Company today announces the appointment of
Additionally, in June,
Second-Quarter 2018 Financial Results
- Net loss applicable to the common shareholders for the second quarter of 2018 was
$17.5 million, or $(0.12)per share, compared to a net loss of $17.7 million, or $(0.13)per share, for the second quarter of 2017. The decreased net loss is primarily due to a decrease in total operating expenses during the three months ended June 30, 2018. The decrease in expense was offset by less collaboration revenue realized during the three months ended June 30, 2018, due to the implementation of ASC 606.
- Research and development expenses were
$7.5 millionfor the second quarter of 2018, compared to $10.8 millionfor the second quarter of 2017. The decrease in research and development expenses for the three months ended June 30, 2018is primarily due to decreased preclinical activity related to our cell and gene therapy programs.
- General and administrative expenses were
$4.9 millionfor the second quarter of 2018, compared to $3.8 millionfor the second quarter of 2017. The increase in general and administrative expenses for the three months ended June 30, 2018is primarily due to contracted outside service costs.
- The Company ended the quarter with unrestricted cash resources of approximately
In addition, a prepayment of approximately
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,
Forward-Looking Statements Disclaimer
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 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 and readouts 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, including receiving clearance from the
|Ziopharm Oncology, Inc.
Statements of Operations
(in $ thousands except share and per share data)
|Three Months Ended June 30|
|Research & Development||$7,489||$10,831|
|General and Administrative||$4,889||$3,780|
|Total operating expenses||$12,378||$14,611|
|Loss from operations||($12,378||)||($13,014||)|
|Other income (expense), net||$164||$ 86|
|Change in fair value of derivative liabilities||$183||$ 66|
|Preferred stock dividends||($5,462||)||($4,865||)|
|Net loss applicable to common stockholders||($17,493||)||($17,727||)|
|Basic and diluted net loss per share|
Weighted average common shares outstanding used to compute basic and diluted net loss per share
|Ziopharm Oncology, Inc.
Balance Sheet Data
|June 30, 2018||December 31, 2017|
|Cash and cash equivalents||$40,404||$70,946|
|Total stockholders' (deficit)||($139,235||)||($96,806||)|
Source: ZIOPHARM Oncology Inc