On March 15, 2018 VBL Therapeutics (Nasdaq: VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, reported its financial results for the quarter and year-ended December 31, 2017 and provided a corporate update (Press release, VBL Therapeutics, MAR 15, 2018, View Source [SID1234524795]).

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"VBL has more than $50 million in cash, which will enable us to continue the development of VB-111 and our promising pipeline through 2020," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "We intend to continue the ongoing OVAL trial, our Phase 3 potential registration trial in platinum-resistant ovarian cancer, in collaboration with the GOG Foundation. We intend to add an interim analysis for evidence of efficacy signal in our OVAL trial, sooner than in our original plan. We expect that the interim readout may be available during the first half of 2019".

"Beyond VB-111, we have a strong pipeline, including our exciting MOSPD2 program for oncology and inflammatory indications. We intend to present new data from this program in oncology as a late-breaking news at the forthcoming American Academy of Cancer Research (AACR) (Free AACR Whitepaper) meeting in April 2018".

Fourth Quarter and Recent Corporate Highlights:

●Reported top-line results from its pivotal Phase 3 GLOBE study in patients with rGBM which was designed to evaluate VB-111 in combination with bevacizumab (Avastin), compared with bevacizumab alone.

The study did not meet its pre-specified primary endpoint of overall survival (OS) or secondary endpoint progression-free-survival (PFS).

●Announced the initiation of the Phase 3 potential registration trial, OVAL, studying VB-111 in platinum-resistant ovarian cancer.

The OVAL study has been designed to enroll up to 350 adult patients at approximately 70 clinical sites in the U.S. and Israel. Patients are being randomized 1:1 to VB-111 in combination with chemotherapy, or chemotherapy alone. The primary endpoint is overall survival.

The study is being conducted in collaboration with the Gynecologic Oncology Group (GOG) Foundation, Inc., a leading organization for research excellence in the field of gynecology malignancies.

The European Medicines Agency (EMA) designated VB-111 as an "orphan medicinal product" for the treatment of ovarian cancer in October 2017.

●Signed an exclusive license agreement with NanoCarrier Co., Ltd. (TSE Mothers: 4571) for the development, commercialization and supply of VB-111 in Japan.

In February 2018, VBL received a milestone payment in relation to this agreement.

●Opened new gene therapy manufacturing plant in Modiin, Israel.

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.).

The facility was constructed with the support of the Israel Innovation Authority of the Ministry of Economy.

●Appointed David Hastings and Susan Kelley, M.D. to its Board of Directors.

●In November 2017, raised $18.75 million in gross proceeds, before deducting the underwriting discounts and commissions and other estimated expenses, in a public offering of common stock.

Year Ended December 31, 2017 Financial Results

●Revenues: In 2017 we recognized revenues of $13.8 million, generated from the licensing and development agreement with NanoCarrier.

●Cash Position: At December 31, 2017, we had cash, cash equivalents and short-term bank deposits of $54.7 million and working capital of $50.9 million. We expect that our cash and cash equivalents and short-term bank deposits will enable us to fund our operating expenses and capital expenditure requirements through 2020.

●R&D Expenses: Research and development expenses for the year ended December 31, 2017 were approximately $17.8 million, compared to approximately $12.4 million in the year ended December 31, 2016.

●G&A Expenses: General and administrative expenses for the year ended December 31, 2017 were approximately $5.8 million, compared to approximately $3.8 million in the year ended December 31, 2016.

Comprehensive Loss: The Company reported a comprehensive loss for the year ended December 31, 2017 of $10.2 million, or ($0.37) per share, compared to a net loss of $16.0 million, or ($0.64) per share in the year ended December 31, 2016.

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Conference ID: 7392936