On August 15, 2016 VBL Therapeutics (NASDAQ:VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, reported financial results and provided a business update for the second quarter and six month period ended June 30, 2016 (Press release, VBL Therapeutics, AUG 15, 2016, View Source;p=irol-newsArticle&ID=2195332 [SID:1234514575]).

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"The second quarter of 2016 was marked by further progress in the clinic with our lead oncology product candidate, VB-111, which has shown evidence of benefit in multiple tumor types," said Dror Harats, Chief Executive Officer of VBL Therapeutics. "The positive results we announced during ASCO (Free ASCO Whitepaper) in platinum resistant ovarian cancer and in rGBM add to the growing body of evidence suggesting that VB-111 has potent anti-tumor activity, and importantly, that it appears to be extending survival in these difficult to treat patients."

"Our ongoing Phase 3 randomized controlled GLOBE study of VB-111 in combination with Avastin is proceeding on track," continued Dr. Harats. "The trial, which is enrolling patients in the U.S., Canada and Israel, is covered by a Special Protocol Assessment (SPA). Our goal is to conduct an event-driven interim analysis according to the study protocol, and we think this will likely happen in the first half of 2017. We also strengthened our balance sheet during the second quarter, with the successful completion of a common stock offering, raising net proceeds of approximately $21.9 million."

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

Presented positive clinical data on VB-111 in platinum resistant ovarian cancer during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting
VB-111 demonstrated a statistically significant increase in overall survival in platinum resistant ovarian cancer at therapeutic vs. low dose level (810 days vs. 172 days, p=0.042)
60% durable response rate (as measured by reduction in CA-125 biomarker) observed with VB-111, approximately 2x the historical response with Avastin plus chemotherapy in ovarian cancer
Clinical data in ovarian cancer supported by immuno-therapeutic effect observed in biopsies following treatment with VB-111
At ASCO (Free ASCO Whitepaper), presented new data in recurrent glioblastoma (rGBM), comparing clinical outcomes with VB-111 with pooled data from 8 historical studies that investigated Avastin (bevacizumab)
Median overall survival for patients on continuous exposure of VB-111 was 59 weeks, compared with 32 weeks in historical pooled Avastin trials (p= 0.0295).
12-Month overall survival was 57% in patients on continuous exposure of VB-111, compared with 24% in historical pooled Avastin trials (p=0.03).
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.
Appointed Rachel W. Humphrey, MD, Ph.D., an expert in oncology drug development and one of the pioneers of the immune-oncology field, to head the VBL’s scientific advisory board.
Strengthened cash position by raising approximately $21.9 million in net proceeds in a registered direct public offering.
Second Quarter Ended June 30, 2016 Financial Results:

R&D Expenses: Research and development expenses (net) were $2.2 million for the second quarter of 2016, compared to $2.0 million in second quarter of 2015.
G&A Expenses: General and administrative expenses for the second quarter of 2016 were $1.1 million, compared to $1.1 million in the second quarter of 2015.
Net Loss: Net loss for the second quarter of 2016 was $3.3 million, or ($0.14) per share, compared to a net loss of $3.0 million, or ($0.15) per share in the second quarter of 2015.
Cash Position: At June 30, 2016, cash, cash equivalents and short-term bank deposits totaled $51.6 million, inclusive of the public offering of common stock mentioned above. The Company expects that these funds will support operating expenses and capital expenditure requirements into 2019 and are expected to be sufficient to enable completion of the on-going Phase 3 registration clinical trial of VB-111 in rGBM, the Phase 2 clinical trial of VB-111 in thyroid cancer and the potential registration clinical trial for VB-111 in ovarian cancer.
Six Months Ended June 30, 2016 Financial Results:

R&D Expenses: Research and development expenses (net) were $6.2 million for the six month period of 2016, compared to $4.0 million in same period of 2015.
G&A Expenses: General and administrative expenses for the six month period of 2016 were $1.9 million, compared to $1.9 million in the same period of 2015.
Net Loss: Net loss for the six months of 2016 was $8.0 million, or ($0.35) per share, compared to a net loss of $5.9 million, or ($0.30) per share in the first six months of 2015.