VBL Therapeutics Announces First Quarter 2017 Financial Results

TEL AVIV, Israel, May 15, 2017 (GLOBE NEWSWIRE) -- VBL Therapeutics (NASDAQ:VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, announced financial results for the first quarter ended March 31, 2017, as well as a corporate update.

“We continue to execute on our strategy to develop VB-111, a targeted anti-cancer gene-therapy agent that is positioned to treat a wide range of solid tumors,” said Professor Dror Harats, Chief Executive Officer of VBL Therapeutics.  “Our GLOBE pivotal trial in rGBM has completed enrollment and the DSMB committee reviewed the GLOBE safety data collected through a cutoff date in March 2017 and unanimously recommended that the study continue as planned.  Based on the current event rate in this trial, we now expect the interim analysis to occur in the third quarter of 2017, with top line data from the full dataset becoming available in early 2018. Our planned Phase 3 clinical trial of VB-111 in ovarian cancer is expected to begin in the second half of 2017.”

“We are also exploring the potential of VB-111 in other tumor types, and recently presented data at the ASGCT conference showing an enhanced benefit of VB-111 in combination with a checkpoint inhibitor in preclinical models of lung cancer and melanoma. Accordingly, we intend to launch an exploratory study of VB-111 in combination with a checkpoint inhibitor in lung cancer by year-end 2017,” continued Prof. Harats.  “Supporting this progress is a strong balance sheet, with $39.6 million in cash on hand at the end of the first quarter, which we believe will be sufficient to fund our operating expenses and capital expenditure requirements into 2019.”

First Quarter and Recent Corporate Updates

• Completed enrollment in the pivotal GLOBE study investigating VB-111 in rGBM.
    °  Enrollment in the study, 256 patients in total, was completed in December 2016, five months ahead of schedule.
    °  The DSMB committee reviewed the GLOBE safety data collected through a cutoff date in March 2017 and unanimously recommended that the study continue as planned. 
    °  Company expects the GLOBE interim analysis to occur in the third quarter of 2017, with top-line results from the full dataset becoming available in early 2018.
• Presented preclinical data on VB-111 in combination with a checkpoint inhibitor at the 20th Annual American Society of Gene & Cell Therapy (ASGCT) meeting in Washington DC.
    °  Combination of VB-111 and anti-PD-L1 resulted in an amplified antitumor effect in models of lung cancer and melanoma.
• Data from the prior Phase 2 clinical trial that investigated VB-111 in rGBM have been selected for presentation at the 2017 American Society of Clinical Oncology (ASCO) annual meeting on June 5. 
    °  The poster at ASCO will feature new data on individual patients who were enrolled in this trial.
• Announced full results from exploratory Phase 2 study of VB-111 in patients with advanced, differentiated thyroid cancer.
    °  The study previously met its primary endpoint, defined as 6-month progression-free-survival (PFS-6) of 25%, with a dose response. An overall survival benefit was seen with a tail of more than 40% at 3.7 years for the therapeutic-dose cohort.
• Published research on MOSPD2, a potential novel immune-oncology target at the annual American Association of Cancer Research (AACR) meeting in Washington DC.
    °  A paper discussing MOSPD2 was published online in The Journal of Immunology in January 2017.
    °  Targeting of MOSPD2 may have several therapeutic applications, including inhibition of monocyte migration in chronic inflammatory conditions inhibition of tumor cell metastases and targeting of MOSPD2 tumor cells. 
    °  VBL’s “VB-600 series” of pipeline candidates is being developed toward these applications.
• Announced new data supporting use of Lecinoxoids in NASH
    °  In a retrospective analysis of five Phase 1 studies and three Phase 2 studies, liver enzyme tests were performed for subjects dosed with VB-201, and identified a statistically significant time- and dose-dependent reduction of alkaline phosphatase (ALP) blood levels as well as a reduction in levels of gamma-glutamyltransferase (GGT), in patients treated orally with VB-201.  Reductions in these biomarkers may indicate improvement in liver fibrosis.

First Quarter 2017 Financial Results:

• Cash Position:  At March 31, 2017, we had cash, cash equivalents and short-term bank deposits totaling $39.6 million and working capital of $37.2 million. We expect that our cash, cash equivalents and short-term bank deposits will enable us to fund our operating expenses and capital expenditure requirements into 2019 and is expected to be sufficient to enable us to complete our ongoing Phase 3 clinical trial of VB-111 in rGBM, to support our planned potential registration trial in ovarian cancer and an exploratory clinical study of VB-111 in combination with a checkpoint inhibitor in lung cancer, as well as to support the investment in the new Modiin facility to which we intend to relocate in a few months.
• R&D Expenses: Research and development expenses for the quarter ended March 31, 2017 were approximately $4.1 million, compared to approximately $4.0 million in the same period of 2016.
• G&A Expenses:  General and administrative expenses for the quarter ended March 31, 2017 were approximately $1.1 million, compared to approximately $0.9 million in the same period of 2016.
• Net Loss:  The Company reported a net loss for the quarter ended March 31, 2017 of $5.0 million, or ($0.19) per share, compared to a net loss of $4.7 million, or ($0.21) per share in the quarter ended March 31, 2016. 

About VBL
Vascular Biogenics Ltd., operating as VBL Therapeutics, is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class treatments for cancer. The Company’s lead oncology product candidate, ofranergene obadenovec (VB-111), is a first-in-class biologic agent that uses a dual mechanism to target solid tumors. It utilizes an angiogenesis-specific sensor (VBL's PPE-1-3x proprietary promoter) to specifically target the tumor vasculature, by induction of cell death in angiogenic endothelial cells in the tumor milieu. Moreover, it is an immune-stimulant that triggers a local anti-tumor immune response, which is accompanied by recruitment of CD8 T-cells and apoptosis of tumor cells. Ofranergene obadenovec is positioned to treat a wide range of solid tumors and is conveniently administered as an IV infusion once every two months. It has been observed to be well-tolerated in >200 cancer patients and we have observed its efficacy signals in an “all comers” Phase 1 trial as well as in three tumor-specific Phase 2 studies. Ofranergene obadenovec is currently being studied in a Phase 3 pivotal trial for recurrent Glioblastoma, conducted under an FDA Special Protocol Assessment (SPA).

Forward Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to”, “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. These forward-looking statements include, but are not limited to, statements regarding the clinical development of ofranergene obadenovec (VB-111) and its therapeutic potential, ongoing and planned clinical trials and clinical results, including the timing thereof, our other pipeline candidates, including the clinical development and therapeutic potential of our VB-600 series of pipeline candidates and Lecinoxoids in NASH, our new Modiin facility and our cash position and financial outlook. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and the risk that historical clinical trial results may not be predictive of future trial results. In particular, results from our pivotal Phase 3 clinical trial of ofranergene obadenovec (VB-111) in rGBM may not support approval of ofranergene obadenovec for marketing in the United States, notwithstanding the positive results seen in prior clinical experience. A further list and description of these risks, uncertainties and other risks can be found in the Company’s regulatory filings with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. VBL Therapeutics undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.