- 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.
- 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.
- 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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