TEL AVIV, Israel, Nov. 10, 2016 (GLOBE NEWSWIRE) -- VBL Therapeutics (NASDAQ:VBLT), today reported financial results and provided a business update for the third quarter and nine month period ended September 30, 2016.
“We continue to focus our resources on advancing ofranergene obadenovec (VB-111), our targeted anti-cancer agent that is in late stage clinical trials to treat a range of solid tumors,” said Dror Harats, Chief Executive Officer of VBL Therapeutics. “We expect to complete the enrollment for our pivotal GLOBE study in recurrent GBM by the end of this year, five months ahead of plan. An event-driven interim analysis is expected to occur in mid-2017.”
“We recently announced plans to establish a new manufacturing facility in Modiin, Israel. The development of manufacturing capability is an important step as we advance multiple clinical trials and move closer to potential commercialization of VB-111,” continued Dr. Dror Harats.
“VBL is well capitalized, with $48.9 million in cash on our balance sheet at September 30. We believe that our current cash will support operations into 2019, well beyond the readout of the GLOBE trial, while supporting a potential registration study in ovarian cancer as well as the investment in the new manufacturing facility,” said Dr. Harats.
Third Quarter Corporate Highlights:
- The ongoing pivotal GLOBE Phase III registration study investigating ofranergene obadenovec (VB-111) in recurrent GBM is proceeding well and recruiting patients ahead of schedule, at centers in the U.S., Canada, and Israel. We expect to complete enrollment for the GLOBE Study by the end of 2016, five months ahead of plan.
- The GLOBE study is comparing ofranergene obadenovec in combination with bevacizumab (Avastin®) to bevacizumab alone with a recruitment target of about 252 patients. The study is proceeding under special protocol assessment (SPA).
- Ofranergene obadenovec (VB-111) is a unique biologic agent that offers a novel way for targeting of solid tumors’ blood supply and triggering a specific anti-tumor immune response.
- GLOBE is an event-driven trial. The Company expects to conduct an interim analysis for the study in mid-2017. Full trial results are expected in early 2018.
- Last month VBL engaged in a long-term lease contract for a new stand-alone manufacturing facility in Modiin, Israel. The site will house VBL's local biological drugs manufacturing facility, as the company plans ahead for commercialization of ofranergene obadenovec, if approved.
Third Quarter Ended September 30, 2016 Financial Results:
- R&D Expenses: Research and development expenses were approximately $2.2 million for the third quarter of 2016, compared to approximately $5.0 million in the third quarter of 2015. This difference relates to unleveled spending in 3Q15. The variance is leveled in the 9 month results, as shown below.
- G&A Expenses: General and administrative expenses were approximately $1.1 million for the third quarter of 2016, compared to approximately $0.8 million in in the third quarter of 2015.
- Net Loss: The company reported a net loss of approximately $3.2 million, or ($0.12) per ordinary share in the third quarter of 2016, compared to a net loss of approximately $5.8 million, or ($0.29) per ordinary share in the third quarter of 2015.
- Cash Position: At September 30, 2016, the Company had cash, cash equivalents and short-term bank deposits totaling $48.9 million and working capital of $46.0 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. Our cash position is expected to be sufficient for completion of our on-going Phase 3 clinical trial of VB-111 in rGBM, for a potential registration trial of VB-111 in ovarian cancer and to support the investment in the new Modiin facility.
Nine Months Ended September 30, 2016 Financial Results:
- R&D Expenses: Research and development expenses were approximately $8.5 million for the nine-month period of 2016, compared to approximately $9.0 million in the same period of 2015.
- G&A Expenses: General and administrative expenses for the nine month period of 2016 were $3.0 million, compared to $2.7 million for the same period of 2015.
- Net Loss: Net loss for the nine-month period was approximately $11.2 million, or ($0.46) per share, compared to a net loss of $11.7 million, or ($0.59) per share in the same period of 2015.
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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, targeted anti-cancer gene-therapy agent that is positioned to treat a wide range of solid tumors. It 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).
About Ofranergene Obadenovec (VB-111)
ofranergene obadenovec is a unique biologic agent that uses a dual mechanism to target solid tumors. Based on a non-integrating, non-replicating, Adeno 5 vector, ofranergene obadenovec utilizes VBL's proprietary Vascular Targeting System (VTS™) to target the tumor vasculature for cancer therapy. Unlike anti-VEGF or TKIs, ofranergene obadenovec does not aim to block a specific pro-angiogenic pathway; instead, it uses an angiogenesis-specific sensor (VBL's PPE-1-3x proprietary promoter) to specifically induce cell death in angiogenic endothelial cells in the tumor milieu. This mechanism retains activity regardless of baseline tumor mutations or the identity of the pro-angiogenic factors secreted by the tumor and shows efficacy even after failure of prior treatment with other anti-angiogenics. Moreover, ofranergene obadenovec induces specific anti-tumor immune response, which is accompanied by recruitment of CD8 T-cells and apoptosis of tumor cells.
Ofranergene obadenovec completed a Phase 2 study in rGBM, which showed a statistically significant improvement in overall survival in patients treated with ofranergene obadenovec through progression, compared to either patients treated with ofranergene obadenovec followed by bevacizumab alone, or to historical bevacizumab data. In a Phase 2 trial for recurrent platinum-resistant ovarian cancer, ofranergene obadenovec demonstrated a statistically significant increase in overall survival and 60% durable response rate (as measured by reduction in CA-125), approximately 2x the historical response with bevacizumab plus chemotherapy in ovarian cancer. In a Phase 2 study in recurrent, iodine-resistant differentiated thyroid cancer, ofranergene obadenovec met the primary endpoint and provided evidence of disease stabilization and a positive safety profile. Ofranergene obadenovec has received Fast Track Designation for recurrent glioblastoma in the U.S. and orphan drug status for glioblastoma in both the U.S. and EU.
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 and clinical results, including statements related to the GLOBE study and the timing and progress thereof, our Modiin manufacturing facility, 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 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, including in our annual report on Form 20-F for the year ended December 31, 2015. 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.
|VASCULAR BIOGENICS LTD.|
|CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION|
|September 30,||December 31,|
|U.S. dollars in thousands|
|Cash and cash equivalents||$||30,099||$||7,090|
|Short-term bank deposits||18,785||30,056|
|Other current assets||877||1,446|
|TOTAL CURRENT ASSETS||49,761||38,592|
|Property and equipment, net||625||326|
|Long-term prepaid expenses||92||320|
|TOTAL NON-CURRENT ASSETS||717||646|
|Liabilities and equity|
|CURRENT LIABILITIES -|
|TOTAL CURRENT LIABILITIES||3,794||4,158|
|NON-CURRENT LIABILITIES -|
|Severance pay obligations, net||75||73|
|TOTAL NON-CURRENT LIABILITIES||75||73|
|Other comprehensive income||45||45|
|Additional paid in capital||196,799||174,012|
|TOTAL LIABILITIES AND EQUITY||$||50,478||$||39,238|
|VASCULAR BIOGENICS LTD.|
|CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE LOSS|
|Three months ended September 30||Nine months ended September 30|
|U.S. dollars in thousands|
|RESEARCH AND DEVELOPMENT EXPENSES, net||$||2,235||$||4,963||$||8,468||$||8,982|
|GENERAL AND ADMINISTRATIVE EXPENSES||1,068||772||2,991||2,705|
|FINANCIAL EXPENSES (INCOME), net||(109||)||52||(262||)||41|
|LOSS PER ORDINARY SHARE,|
|Basic and diluted||$||0.12||$||0.29||$||0.46||$||0.59|
|Number of shares||Number of shares|
|WEIGHTED AVERAGE ORDINARY SHARE OUTSTANDING–|
|Basic and diluted||26,875,818||19,927,241||24,323,508||19,913,489|
|VASCULAR BIOGENICS LTD.|
|CONDENSED INTERIM CASH FLOW STATEMENTS|
|Nine months ended|
|U.S. dollars in thousands|
|CASH FLOWS FROM OPERATING ACTIVITIES:|
|Loss for the period||$||(11,197||)||$||(11,728||)|
|Adjustments required to reflect net cash used in operating activities (see appendix A)||1,134||2,671|
|Net cash used in operating activities||(10,001||)||(9,029||)|
|CASH FLOWS FROM INVESTING ACTIVITIES:|
|Purchase of property and equipment||(393||)||(41||)|
|Investment in short-term deposits||—||(15,655||)|
|Maturity of short-term deposits||11,400||—|
|Net cash generated from (used in) investing activities||11,007||(15,696||)|
|CASH FLOWS FROM FINANCING ACTIVITIES:|
|Exercise of employees stock options||83||39|
|Issuance of ordinary shares and warrants, net||21,860||—|
|Net cash generated from financing activities||21,943||39|
|NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS||22,949||(24,686||)|
|CASH AND CASH EQUIVALENTS AT BEGINNING OF THE YEAR||7,090||36,783|
|EXCHANGE GAINS (LOSSES) ON CASH AND CASH EQUIVALENTS||60||(132||)|
|CASH AND CASH EQUIVALENTS AT END OF THE PERIOD||$||30,099||$||11,965|
|Adjustments required to reflect net cash used in operating activities:|
|Exchange (gains) losses on cash and cash equivalents||(60||)||132|
|Net changes in severance pay||-||(1||)|
|Changes in working capital :|
|Decrease in other current assets||569||129|
|Decrease (increase) in long-term prepaid expenses||228||(349||)|
|Increase (decrease) in accounts payable and accruals:|
Source: VBL Therapeutics