VBL Therapeutics Announces First Quarter 2016 Financial Results and Provides Business Update

TEL AVIV, Israel, May 13, 2016 (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, today reported financial results and provided a business update for the first quarter ended March 31, 2016.

“The first quarter saw continued progress in advancing our lead candidate VB-111, a first-in-class gene-therapy based agent, in several solid tumor indications, the most advanced program being the Phase III GLOBE Study in recurrent glioblastoma multiforme (rGBM),” said Dror Harats, President and Chief Executive Officer of VBL Therapeutics. “The trial is recruiting on schedule. It is event driven and interim data is expected in the first half of 2017, with full trial results expected late in 2017 or early 2018. We were very pleased to have two abstracts on VB-111 accepted for the forthcoming American Society of Clinical Oncology (ASCO) annual meeting in June. At the time of presentation we will discuss new data, including preliminary survival data, from the Phase II study of VB-111 in recurrent platinum resistant ovarian cancer. The Company is well capitalized, with cash, equivalents and short-term bank deposits of $33.2 million.”

First Quarter and Year-to-Date Clinical and Corporate Highlights:

• The ongoing GLOBE™ Study is a randomized, controlled Phase 3 trial of VB-111 in rGBM, that is proceeding under a special protocol assessment (SPA) granted by the U.S. Food and Drug Administration (FDA). The trial is designed to enroll up to 252 patients with rGBM in the United States, Canada and Israel.
  • The trial is comparing VB-111 in combination with bevacizumab (Avastin®) to bevacizumab alone in recurrent glioblastoma (rGBM).
  • Recruitment is proceeding according to plan and an interim analysis is expected to occur in the first half of 2017, based on enrollment and VB-111 activity.
  • In February, the Company announced that the first patient in Israel had been enrolled.
• Two abstracts discussing the Phase 2 clinical studies of VB-111 have been accepted for presentation at the 2016 ASCO Annual Meeting, which will take place June 3 to June 7 in Chicago.
  • Tumor responses and preliminary survival data in a phase 2 trial of ofranergene obadenovec (VB-111) combined with paclitaxel in patients with recurrent platinum resistant ovarian cancer.
  • Ofranergene obadenovec (VB-111), an anti-cancer gene therapy in combination with bevacizumab to improve overall survival compared to bevacizumab monotherapy in patients with rGBM:  A phase 2 historically controlled trial.
• On May 4^th, the Company held a Key Opinion Leader (KOL) meeting for the investment community in New York City:  The event featured a presentation from Dr. Timothy Cloughesy, Director of the UCLA Neuro-Oncology Program.
  • Dr. Cloughesy outlined the treatment options for newly diagnosed and Recurrent GBM (rGBM) patients. He discussed the VB-111 Phase 2 data in rGBM and the potential role of this drug candidate in the disease.
  • An archive of the event is available for replay here.
• Results for VB-201 and VB-703 for the Treatment of Non-Alcoholic Steatohepatitis (NASH) and Liver Fibrosis were published in Digestive Diseases & Sciences Magazine:
  • Lexinoxoids are small molecules developed by VBL that antagonize Toll-like receptor 2 and 4 (TLR-2 and TLR-4) mediated activation and inhibit monocyte migration. TLR-2- and TLR-4 are known to play a role in nonalcoholic fatty liver disease.
  • The study results demonstrated that Lexinoxoids can restrict liver inflammation and ameliorate liver fibrosis in a mouse model.

First Quarter 2016 Financial Results:

• Cash Position:  At March 31, 2016, cash, cash equivalents and short-term bank deposits totaled $33.2 million, with working capital at $30 million. The Company expects that these funds will support operating expenses and capital expenditure requirements into mid-2018 and are expected to be sufficient to enable completion of the on-going Phase 3 clinical trial of VB-111 in rGBM, the Phase 2 clinical trial of VB-111 in thyroid cancer and the Phase 2 clinical trial for VB-111 in ovarian cancer.
• R&D Expenses:  Research and development expenses (net) were $4.0 million for the first quarter of 2016, compared to $2.0 million in first quarter of 2015. The increase in research and development expenses is mainly related to increased expenses for the VB-111 subcontractors and consultants in 2016 as the Phase 3 pivotal trial of VB-111 in rGBM commenced in August 2015.
• G&A Expenses:  General and administrative expenses for the first quarter of 2016 were $0.9 million, compared to $0.8 million in the first quarter of 2015.
• Net Loss:  Net loss for the first quarter of 2016 was $4.7 million, or ($0.21) per share, compared to a net loss of $3.0 million, or ($0.15) per share in the first quarter of 2015.

Avastin™ is a registered trademark of Genentech.

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, VB-111, is a first-in-class, targeted anti-cancer gene-therapy agent that is positioned to treat a wide range of solid tumors. VB-111 is conveniently administered as an IV infusion once every two months. It has been observed to be well-tolerated in >170 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. The mechanism of VB-111 combines blockade of tumor vasculature with an anti-tumor immune response. This mechanism retains activity regardless of baseline tumor mutations or the identity of the pro-angiogenic factors secreted by the tumor. VB-111 is currently being studied in a Phase 3 pivotal trial for Recurrent Glioblastoma (rGBM). The trial is being conducted under an FDA Special Protocol Assessment (SPA), and VB-111 has obtained fast track and Orphan designations.

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 VB-111 and its therapeutic potential and clinical results, including statements related to the GLOBE study and our cash position and funding requirements. 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 VB-111 in rGBM may not support approval of VB-111 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.