On March 28, 2019 VBL Therapeutics (Nasdaq: VBLT) reported financial results for the year ended December 31, 2018, and provided a corporate update (Press release, VBL Therapeutics, MAR 28, 2019, View Source [SID1234534697]).

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"We continue to advance our clinical program for VB-111 in ovarian cancer and are also exploring additional oncology indications," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "The ongoing Phase 3 OVAL trial in platinum resistant ovarian cancer continues to enroll patients and we expect an interim efficacy readout by year end 2019.

"Recently, at the Society of Gynecologic Oncology (SGO) conference, we presented data showing that in 3 out of 3 ovarian cancer patients from whom we obtained tumor biopsies, including a Phase 3 patient who was enrolled in the early unblinded stage of the Phase 3 OVAL study, VB-111 resulted in recruitment of infiltrating T-cells into the tumor, turning it from `cold` to `hot`. This important finding suggests that VB-111 may be applied to other `cold` tumors, in which checkpoint inhibitors show limited or no efficacy. Furthermore, although limited, we are encouraged that in the open label part of the Phase 3 study, data seem to recapitulate the activity of VB-111 in our prior Phase 2 trial for ovarian cancer.

"Based on these data on the potential ability for VB-111 to turn immunologically `cold` tumors `hot`, we expect the launch of a Phase 2 clinical trial with the National Cancer Institute (NCI), exploring VB-111 in colon cancer in combination with a checkpoint inhibitor, in the second half of 2019.

"We are also seeing renewed interest from the medical oncology community in the potential of VB-111 to treat recurrent Glioblastoma (rGBM) based on MRI analyses performed by UCLA. Accordingly, recruitment in an investigator-sponsored study for VB-111 in rGBM is expected to commence in Q2 2019. This study will be conducted at top neuro-oncology centers in the US. Therefore, toward late 2019 we expect there will be three ongoing clinical trials of VB-111, in ovarian cancer, colon cancer and rGBM.

"We also have valuable pipeline assets, including our MOSPD2 antibody programs in inflammation and oncology, as well as VB-201, for which we have recently signed a strategic exclusive option license agreement for veterinary use, with potential payments to VBL that may exceed €50 million during the license term."

"We had more than $50 million in cash and cash equivalents at December 31, 2018. This is expected to provide us with sufficient resources to continue to develop VB-111 and other product candidates and to fund our operating expenses and capital expenditure requirements through 2021," said Amos Ron, Chief Financial Officer of VBL Therapeutics.

Fourth Quarter and Recent Corporate Highlights:

Executed a strategic exclusive option license agreement with one of the world-leading European animal health companies, for the development of VBL’s proprietary anti-inflammatory molecule, VB-201, for veterinary use. VBL is receiving an undisclosed up-front payment and upon exercising the option to license, VBL will receive additional milestones and royalties, which may exceed €50 million. VBL retains worldwide rights for the use of VB-201 for the treatment of humans.
Presented new data at the Society of Gynecologic Oncology (SGO) 50th Annual Meeting on Women’s Cancer demonstrating the potential of VB-111 to stimulate the immune system and drive immune cells to infiltrate the tumor microenvironment, switching tumors from immunologically `cold` to `hot`.
Presented new analysis from the Phase 3 GLOBE study of VB-111 in patients with rGBM at the 2018 Society for Neuro-Oncology (SNO) annual meeting. New data provided insight into how the VB-111 treatment regimen may influence its anti-tumor activity, and thus why use of Avastin without prior priming with VB-111 monotherapy can block VB-111 activity. This likely explains why the positive Phase 2 data in rGBM were not replicated in the GLOBE Phase 3 study.
Presented new data on the potential of VB-600 platform of antibodies targeting MOSPD2 for treatment of various inflammatory indications, including multiple sclerosis (MS), nonalcoholic steatohepatitis (NASH) and rheumatoid arthritis (RA) at the Keystone Symposia on Myeloid Cells. An Investigational New Drug (IND) application for MOSPD2 mAb for treatment of inflammatory indications is planned for submission in 2020.
Published a manuscript demonstrating MOSPD2 as a key player in breast cancer metastasis and a potential target for treatment of solid tumors. Earlier in 2018, VBL presented a late-breaking study at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2018 Annual Meeting, demonstrating a novel bi-specific antibody that induces immune-cell mediated killing of cancer cells through binding MOSPD2. An IND application for bi-specific antibody for treatment of solid tumor indications is planned for 2H2020.
Awarded a non-dilutive grant of over 10 million New Israeli Shekels (approximately $2.9 million) by the Israel Innovation Authority (IIA), to support continued development of VB-111 for 2019.
Fiscal Year Ended December 31, 2018 Financial Results:

Revenues: Revenues related to the VBL’s collaboration in Japan amounted to $0.6 million in the year ended December 31, 2018.
Cash Position: At December 31, 2018, VBL had cash, cash equivalents and short-term bank deposits of $50.5 million and working capital of $47.0 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 through 2021.
R&D Expenses: Research and development expenses, net, after government grants, for the year ended December 31, 2018, were approximately $15.9 million, compared to approximately $17.8 million in the same period in 2017.
G&A Expenses: General and administrative expenses for the year ended December 31, 2018 were $5.2 million, compared to $5.8 million for the same period in 2017.
Comprehensive Loss: VBL reported a net loss for year ended December 31, 2018, of $20.4 million, or ($0.62) per share, compared to a net loss of $10.2 million, or ($0.37) per share, in the year ended December 31, 2017.
For further details on VBL’s financials, please refer to Form 20-F filed with the SEC.

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