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- VBL is well capitalized, cash sufficient for more than 3 years, beyond key inflection points
- VBL continues development of VB-111 for Ovarian Cancer with the OVAL Phase 3 trial ongoing, and intends to explore VB-111 activity in additional tumor types
- MOSPD2 programs for oncology and inflammation are in progress; VBL aims for first IND by YE2019.
TEL AVIV, Israel, Aug. 16, 2018 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT) today announced financial results for the second quarter ended June 30, 2018 and provided a corporate update.
“VBL is well capitalized, with more than $58 million in cash, which will enable us to continue the development of VB-111 in ovarian cancer, and to advance our innovative pipeline, including our exciting VB-600 platform targeting MOSPD2, for more than the next three years," said Dror Harats M.D., Chief Executive Officer of VBL Therapeutics.
"We continue to have high conviction in the promise of VB-111 and are focused on executing the ongoing Phase 3 OVAL trial, evaluating VB-111 in platinum-resistant ovarian cancer. We plan to conduct an interim efficacy analysis of this trial in the fourth quarter of 2019.”
“We are excited about our MOSPD2 platform and are very encouraged by the emerging data which highlights the potential of this novel target in the treatment of both cancer and inflammatory disease such as multiple sclerosis. Our goal is to file the first IND from this program by year-end 2019,” continued Prof. Harats.
VBL will present more data on MOSPD2 at the European Committee for Treatment and Research in Multiple Sclerosis (or ECTRIMS) conference on October 11th in Berlin.
Second Quarter and Recent Corporate Highlights:
- Closed a $15.5 million registered direct offering, which will enable the Company to continue the development of VB-111 in ovarian cancer, and to advance the pipeline, including the VB-600 platform targeting MOSPD2, for the next three years.
- Continued to treat patients in the ongoing Phase 3 OVAL trial, evaluating VB-111 in platinum-resistant ovarian cancer. An efficacy interim readout is expected to occur in the fourth quarter of 2019.
- Conducted analyses of the VB-111 Phase 3 GLOBE trial in recurrent glioblastoma (rGBM). We are particularly investigating the possibility that the treatment regimen of the GLOBE trial, which was performed under a pre-agreed Special Protocol Assessment (SPA), may have impaired the activity of VB-111. Our analyses have not revealed any other risk factor that can explain the difference in outcome compared with the prior Phase 2 trial. The Company plans to present additional data on GLOBE at the Society for Neuro-Oncology, or SNO meeting, in November 2018.
- Presented positive new data on the Company’s MOSPD2 platform technology in oncology and inflammation in international conferences, and published a paper highlighting MOSPD2 as a potential new target for therapy of solid tumors such as breast cancer.
° Presented a late-breaking study demonstrating a novel bi-specific antibody that induces immune-cell mediated killing of cancer cells through binding to a tumor membrane receptor, MOSPD2, at the American Association for Cancer Research (AACR) 2018 annual meeting.
° Presented data on the role of MOSPD2 in oncology and inflammation at the 2018 BIO international convention. VBL research has shown that knocking out the MOSPD2 gene in mice can protect the animals from developing certain inflammatory diseases. The Company has generated antibodies that block immune cell migration and show efficacy in a model of multiple sclerosis.
° A paper published in the International Journal of Cancer featured VBL data showing that MOSPD2 can play a major role in breast cancer cell migration and metastasis, and that targeting MOSPD2 may be a viable therapeutic strategy to prevent the spreading of breast cancer cells. VBL's data indicate that knock-out of MOSPD2 in tumor cells may reduce metastasis by up to 95% in certain settings.
° VBL is developing the VB-600-MOSPD2 platform of biologic drug candidates for oncology and inflammatory indications. The Company plans to file the first IND in this program by year-end 2019.
Second Quarter Ended June 30, 2018 Financial Results:
- Revenues: revenues related to our collaboration in Japan in the amount of $0.2 million were recognized in the period.
- Cash Position: Cash, cash equivalents and short-term bank deposits at June 30, 2018, were $58.5 million. Working capital at June 30 was $54.7 million. The Company estimates that, based on current projections, the current cash, cash equivalents and short-term bank deposits will be sufficient to fund operating expenses and capital expenditure requirements for more than 3 years.
- R&D Expenses: Research and development expenses for the quarter ended June 30, 2018, were approximately $2.9 million, compared to approximately $3.2 million in the comparable period in 2017. R&D expenses are shown net of grants from the Israel Innovation Authority (IIA).
- G&A Expenses: General and administrative expenses for the quarter ended June 30, 2018 were $1.2 million, compared to $1.9 million for the comparable period in 2017.
- Comprehensive Loss: The Company reported a comprehensive loss for second quarter ended June 30, 2018 of $4.1 million, or ($0.13) per share, compared to a net loss of $4.9 million, or ($0.18) per share in second quarter ended June 30, 2017.
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Vascular Biogenics Ltd., operating as VBL Therapeutics, is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class treatments for cancer. The Company’s lead oncology product candidate, ofranergene obadenovec (VB-111), is a first-in-class, targeted anti-cancer gene-therapy agent that is positioned to treat a wide range of solid tumors. It is conveniently administered as an IV infusion once every two months. It has been observed to be well-tolerated in >300 cancer patients and demonstrated efficacy signals in an “all comers” Phase 1 trial as well as in three tumor-specific Phase 2 studies. Ofranergene obadenovec is currently being studied in a Phase 3 trial for platinum-resistant ovarian cancer.
Forward Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to”, “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. These forward-looking statements include, but are not limited to, statements regarding VB-111, including its clinical development, therapeutic potential and clinical results. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and the risk that historical clinical trial results may not be predictive of future trial results. A further list and description of these risks, uncertainties and other risks can be found in the Company’s regulatory filings with the U.S. Securities and Exchange Commission, including in our annual report on Form 20-F for the year ended December 31, 2017, and subsequent filings with the SEC. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. VBL Therapeutics undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
LifeSci Advisors, LLC
|VASCULAR BIOGENICS LTD.|
|CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION|
|June 30, 2018||December 31, 2017|
|U.S. dollars in thousands|
|Cash and cash equivalents||$||58,530||$||6,694|
|Short-term bank deposits||-||48,035|
|Other current assets||2,002||1,729|
|TOTAL CURRENT ASSETS||60,532||58,458|
|Property and equipment, net||9,143||7,128|
|Long-term prepaid expenses||39||103|
|TOTAL NON-CURRENT ASSETS||9,182||7,231|
|Liabilities and equity|
|TOTAL CURRENT LIABILITIES||5,798||7,569|
|Severance pay obligations, net||121||128|
|TOTAL NON-CURRENT LIABILITIES||2,854||2,220|
|Accumulated other comprehensive income||16||16|
|Additional paid in capital||232,490||221,055|
|TOTAL LIABILITIES AND EQUITY||$||69,714||$||65,689|
|VASCULAR BIOGENICS LTD.|
|CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE LOSS|
|Three Months Ended June 30,||Six Months Ended June 30,|
|U.S. dollars in thousands|
|COST OF REVENUES||(77||)||-||(144||)||-|
|RESEARCH AND DEVELOPMENT EXPENSES, net||$||2,895||$||3,209||$||8,655||$||7,353|
|GENERAL AND ADMINISTRATIVE EXPENSES||1,171||1,898||2,566||3,003|
|FINANCIAL INCOME, net||(98||)||(235||)||(213||)||(450||)|
|LOSS PER ORDINARY SHARE||U.S. dollars|
|Basic and diluted||$||0.13||$||0.18||$||0.37||$||0.37|
|Number of shares|
|WEIGHTED AVERAGE ORDINARY SHARES OUTSTANDING--|
|Basic and diluted||30,147,505||27,009,719||30,017,020||26,957,719|