Vascular Biogenics Ltd (VBLT)

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TEL AVIV, Israel, Nov. 14, 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, today announced financial results for the three and nine months ended September 30, 2017 and provided a corporate update.

“We were pleased to announce last week the signing of an exclusive license agreement with NanoCarrier Co., Ltd. (NanoCarrier) for the development, commercialization and supply of VB-111 in Japan. The license agreement with NanoCarrier provided for an upfront payment of $15 million on November 7, 2017, which strengthens our cash position with non-dilutive money and provides external validation of the Company and VB-111. Our Phase 3 GLOBE Trial investigating VB-111 in recurrent glioblastoma multiforme (rGBM) is moving according to plan, and the Data Safety Monitoring Committee, in their last and final safety review, recommended that the study continue to completion,” said Prof. Dror Harats, Chief Executive Officer of VBL Therapeutics. “We currently expect top line results in the first quarter of 2018. As we advance towards our planned Biologics License Application (BLA) filing for VB-111, we continue to make preparations for launch and commercialization. We were pleased to open our state of the art gene therapy manufacturing facility in Modiin, Israel, which is designed to produce commercial quantities of the drug.”

“Beyond rGBM, we remain on-track to initiate a Phase 3 study of VB-111 in ovarian cancer by year-end 2017,” continued Harats. “We are also planning an exploratory clinical study in combination with a checkpoint inhibitor in lung cancer in the first quarter of 2018.”

Third Quarter and Recent Corporate Highlights:

The independent Data Safety Monitoring Committee (DSMC) overseeing the ongoing Phase 3 GLOBE Study investigating ofranergene obadenovec (VB-111) in recurrent glioblastoma (rGBM) met on September 28, 2017 to conduct its third and final safety review.

? The DSMC reviewed the GLOBE safety data, including mortality data, collected through a cutoff date in August 2017 and unanimously recommended that the study continue as planned, to completion.

? No additional interim analyses are planned, and top-line results from the study are expected to be available in the first quarter of 2018.

VBL opened its new company headquarters and gene therapy manufacturing plant in Modiin, Israel.

? This plant will be the commercial facility for production of the Company’s lead product candidate VB-111, if approved.

? The Modiin facility is the first commercial-scale gene therapy manufacturing facility in Israel and currently one of the largest gene-therapy designated ones in the world (20,000 sq. ft.).

Signed an exclusive license agreement with NanoCarrier Co., Ltd. for the development, commercialization, and supply of VB-111 in Japan.

? VBL received an up-front payment of $15 million, and is entitled to receive greater than $100 million in development and commercial milestone payments, as well as tiered royalties in the high-teens on net sales.

VBL’s cash position is strengthened to fund operations through 2019.

The European Medicines Agency (EMA) designated VB-111 as an “orphan medicinal product” for the treatment of ovarian cancer, adding to the orphan status already granted for glioblastoma in US and Europe.

Third Quarter Ended September 30, 2017 Financial Results:

Cash Position: At September 30, 2017, we had cash, cash equivalents and short-term bank deposits totaling $28.2 million and working capital of $24.4 million. In November we received an additional $15 million in cash as an upfront payment from NanoCarrier Co., Ltd., under the exclusive license agreement to develop, commercialize and supply VB-111 in Japan. We expect that our cash, cash equivalents and short-term bank deposits will enable us to fund our operating expenses and capital expenditure requirements through 2019, and expect such cash, cash equivalents and short-term bank deposits to be sufficient to enable us to complete our on-going Phase 3 clinical trial of VB-111 in rGBM, to prepare for the commercialization of VB-111 for rGBM in the US, to support our planned 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.

R&D Expenses: Research and development expenses for the quarter ended September 30, 2017 were approximately $4.8 million, compared to approximately $2.2 million in the same period of 2016.

G&A Expenses: General and administrative expenses for the quarter ended September 30, 2017 were approximately $1.7 million, compared to approximately $1.1 million in the same period of 2016.

Comprehensive Loss: The Company reported a comprehensive loss for the quarter ended September 30, 2017 of $6.5 million, or ($0.24) per share, compared to a net loss of $3.2 million, or ($0.12) per share in the quarter ended September 30, 2016.

Nine Months Ended September 30, 2017 Financial Results:

R&D Expenses: Research and development expenses (net) were $12.1 million for the nine-month period of 2017, compared to $8.5 million for the nine-month period of 2016.

G&A Expenses: General and administrative expenses for the nine-month period of 2017 were $4.7 million, compared to $3.0 million in the same period of 2016.

Comprehensive Loss: Comprehensive loss for the nine months of 2017 was $16.4 million, or ($0.61) per share, compared to a net loss of $11.2 million, or ($0.46) per share in the nine months of 2016.

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