On November 16, 2020 VBL Therapeutics (Nasdaq: VBLT),reported its financial results for the third quarter ended September 30, 2020, and provided a corporate update (Press release, VBL Therapeutics, NOV 16, 2020, View Source [SID1234571109]).
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"The clinical development program for VB-111, our unique gene therapy for solid tumors, continues to advance well. Patient enrollment in the OVAL Phase 3 study in ovarian cancer continues to be ahead of plan, with almost 200 patients enrolled to date. We had two positive DSMC analyses, indicating that our OVAL trial remains on the right track," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "While it is important to note that the study remains blinded, we are encouraged by the very high response rate (RR), over 50%, that we continue to see to date. This RR is impressively higher than expected for standard-of-care treatments, for which RR is typically in the teens. If successful, the OVAL trial has the potential to establish VB-111 as a new standard of care in a challenging disease setting where patients currently have limited options."
Third Quarter and Recent Key Corporate Highlights:
VB-111
●Provided an update on the ongoing OVAL Phase 3 study investigating VB-111 in patients with platinum-resistant ovarian cancer
○High response rate of over 50% continues to be observed in the total evaluable patient population (treatment and control groups combined) to date, consistent with results from interim analysis reported in March
○Approximately 50% of study participants enrolled to date.
●Initiated an investigator sponsored Phase 2 study of VB-111 in combination with nivolumab (Opdivo), an immune checkpoint inhibitor, for patients with metastatic colorectal cancer.
○Study is being conducted under a Cooperative Research and Development Agreement (CRADA) between the National Cancer Institute (NCI) and VBL.
●Investigator sponsored VB-111 Phase 2 studies, in rGBM, at Dana Farber Cancer Center and other leading neuro-oncology centers is also on track for initiation.
MOSPD2
●Held a pre-IND meeting with the FDA, reaching alignment on the clinical development of lead candidate VB-601 for immune-inflammatory indications; on track to submit an IND for a first-in-human study in the second half of 2021.
●Anti-MOSPD2 mAbs significantly inhibited migration of monocytes isolated from all MS patients included in the study (n=33) by up to 97%, regardless of disease severity, gender or active treatment.
●Two patents granted by the European Patent Office (EPO) for anti-MOSPD2 platform technology to treat cancer and inflammatory conditions, including relapsing-remitting and progressive MS, rheumatoid arthritis, NASH and inflammatory bowel disease.
Corporate:
●In October 2020, Marc Kozin was appointed as Vice Chairman of the Board of Directors. Mr. Kozin will transition to the Chairman role during 2021.
Third Quarter 2020 Financial Results
Cash Position. As of September 30, 2020, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposit totaling $37.3 million and working capital of $30.8 million. VBL expects that its cash and cash equivalents and short-term bank deposits will be sufficient to fund operating expenses and capital expenditure requirements into the third quarter of 2022.
Revenue: Revenues for the third quarter, 2020 were $193 thousand, compared to $79 thousand for the comparable period in 2019.
Research and Development (R&D) Expenses: R&D expenses were $4.8 million for the three months ended September 30, 2020, compared to $3.8 million for the three months ended September 30, 2019.
General and Administrative (G&A) Expenses: G&A expenses were $1.1 million for the three months ended September 30, 2020, compared to $1.2 million for the three months ended September 30, 2019.
Comprehensive Loss: VBL reported a net loss of $5.8 million for the three months ended September 30, 2020, compared to a net loss of $4.9 million for the three months ended September 30, 2019.
For further details on VBL’s financials, please refer to Form 6-k filed with the SEC.
Conference Call:
Monday, November 16 @ 8:30 a.m. ET.
As previously announced, VBL will host a webcast Monday, November 16, 2020, at 8:30 a.m. ET.
The live webcast will be available online and may be accessed from the "Events and Presentation" page of the company website. A replay of the webcast will be available beginning approximately one hour after the conclusion of the call and will remain available for at least 30 days thereafter.