On August 13, 2019 VBL Therapeutics (Nasdaq: VBLT) reported financial results for the second quarter ended June 30, 2019, and provided a corporate update (Press release, VBL Therapeutics, AUG 13, 2019, View Source [SID1234538642]).

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"Our OVAL Phase 3 potential-registration trial of VB-111 in ovarian cancer continues as planned," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "The final results from the prior Phase 2 study (presented at ASCO (Free ASCO Whitepaper) in June) which show statistically significant prolongation of overall survival in platinum-resistant patients, strengthen our belief in the potential of VB-111. An important outcome from Phase 2 was the correlation between CA-125 response and survival benefit. Measurement of CA-125 will, therefore, be the focus of our interim analysis in OVAL, planned for year-end 2019."

Second Quarter and Recent Corporate Highlights:

●Two posters on VB-111, in platinum resistant ovarian cancer and in recurrent glioblastoma multiforme (rGBM), were featured at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2019 Annual Meeting, held in June 2019 in Chicago.
°Final data from the prior Phase 2 study in ovarian cancer demonstrated a statistically significant dose dependent increase in median overall survival in patients treated with therapeutic dose vs. low dose of VB-111 (498 days vs. 172.5 days, p=0.03).
°CA-125 biomarker response (GCIG) was reported in 58% of evaluable patients and was predictive of median overall survival (808 days vs. 351 days) in ovarian cancer, in patients treated with a therapeutic dose of VB-111.
Post treatment tumor infiltrating CD8 T-cells and apoptotic cancer cells indicated tumor transformation from immunologically ‘cold’ to ‘hot’, possibly contributing to the favorable clinical outcomes in ovarian cancer.
°Results were presented from a radiographic analysis conducted at the Brain Tumor Imaging Laboratory at UCLA of the Phase 2 and Phase 3 trials of VB-111 in rGBM. This analysis provides independent, quantitative data that priming with VB-111 results in clinically-meaningful activity in rGBM, which can be seen by MRI signature, demonstrates objective response to VB-111 and is correlated with a statistically significant survival advantage.
°VBL’s new gene therapy pharmaceutical grade manufacturing facility in Modiin, Israel, that was established to support the commercial supply of VB-111 for the first indication, was certified by a European Union (EU) Qualified Person (QP) as being in compliance with EU Good Manufacturing Practices (GMP). This important approval is expected to support future commercialization of VB-111.
Second Quarter ended June 30, 2019 Financial Results:

●Cash Position: At June 30, 2019, the Company had cash, cash equivalents and short-term bank deposits totaling $45.1 million and working capital of $39.1 million. The Company expects that its cash, cash equivalents and short-term bank deposits will enable it to fund operating expenses and capital expenditure requirements for at least two years.
●Revenues: Revenues related to VBL’s collaborations were $0.1 million in the second quarter of 2019.
●R&D Expenses: Research and development expenses, net, after government grants, for the quarter ended June 30, 2019, were approximately $3.7 million, compared to approximately $2.9 million in the same period in 2018.
●G&A Expenses: General and administrative expenses for the quarter ended June 30, 2019 were $1.2 million, as in the same period in 2018.
●Comprehensive Loss: VBL reported a net loss for the quarter ended June 30, 2019 of $4.7 million, or ($0.13) per share, compared to a net loss of $4.1 million, or ($0.13) per share, in the quarter ended June 30, 2018.
For further details on VBL’s financials, please refer to Form 6-K filed with the SEC.

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