On November 14, 2019 VBL Therapeutics (Nasdaq: VBLT) reported financial results for the third quarter ended September 30, 2019, and provided a corporate update (Press release, VBL Therapeutics, NOV 14, 2019, View Source [SID1234551274]).

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"Our OVAL Phase 3 potential-registration trial of VB-111 in ovarian cancer is progressing well and we look forward to an important interim analysis expected in the first quarter of 2020," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "The interim analysis will be based on CA-125 response, a disease marker which correlated with survival benefit in our Phase 2 study in platinum-resistant ovarian cancer patients. We also look forward to the launch of an investigator-sponsored trial of VB-111 in recurrent GBM and an NCI-sponsored trial in colon cancer, expected before the end of 2019."

Third Quarter and Recent Corporate Highlights:

An investigational new drug (IND) application for an investigator-sponsored Phase 2 trial of VB-111 in recurrent glioblastoma ("rGBM") went into effect with the U.S. Food and Drug Administration (FDA). The IND was submitted by Dana-Farber Cancer Institute, on behalf of a group of top neuro-oncology US medical centers. Further details on the trial will be presented at the upcoming Annual Meeting and Education Day of the Society for Neuro-Oncology, to take place November 20 – 24, 2019 at the Marriott Desert Ridge Hotel, Phoenix, Arizona.

An NCI-sponsored trial of VB-111 in colon cancer is expected to begin by year-end 2019. Based on the potential of VB-111 to turn immunologically "cold" tumors "hot", as seen in ovarian cancer biopsies, the new study will evaluate for the first time a combination of VB-111 and a checkpoint inhibitor in colon cancer, a cold tumor in which checkpoints inhibitor are ineffective for the vast majority of patients.

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 step is expected to support future commercialization of VB-111, if approved.

VBL continues to advance the development of lead MOSPD2 antibodies towards IND applications in inflammation and in oncology, expected by year-end 2020. The Company has signed a service agreement with Thermo Fisher Scientific, one of the leading vendors in the antibody field, for production of lead candidate VB-601 for toxicology and clinical development.
Third Quarter ended September 30, 2019 Financial Results:

Cash Position: At September 30, 2019, the Company had cash, cash equivalents, short-term bank deposits and restricted bank deposits totaling $41.1 million and working capital of $34.5 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 approximately two years.

Revenues: Revenues related to VBL’s collaborations were $0.1 million in the third quarter of 2019.

R&D Expenses: Research and development expenses, net, after government grants, were approximately $3.8 million for the quarter ended September 30, 2019, compared to approximately $4.1 million in the same period in 2018.

G&A Expenses: General and administrative expenses for the quarter ended September 30, 2019 were $1.2 million, compared to approximately $1.4 million in the same period in 2018.

Comprehensive Loss: VBL reported a net loss for the quarter ended September 30, 2019 of $4.9 million, or ($0.14) per share, compared to a net loss of $5.4 million, or ($0.15) per share, in the quarter ended September 30, 2018.
For further details on VBL’s financials, please refer to Form 6-K filed with the SEC.

Conference Call: Thursday, November 14th @ 8:30am Eastern Time

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