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TEL AVIV, Israel, May 17, 2018 (GLOBE NEWSWIRE) -- VBL Therapeutics (NASDAQ:VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, today announced financial results for the first quarter ended March 31, 2018 and provided a corporate update.
"We continue to advance the OVAL trial, our Phase 3 potential registration trial in platinum-resistant ovarian cancer, in collaboration with the GOG Foundation," said Yael Cohen M.D., VP Clinical Development of VBL Therapeutic. "We are in the process of amending the protocol to include an interim analysis for evidence of an early efficacy signal with a potential readout from this analysis in the fourth quarter of 2019."
"We are also advancing our MOSPD2 program for oncology and inflammatory indications and, at the recent American Academy of Cancer Research (AACR) meeting, presented new proof-of-concept on the use of a bispecific antibody to kill MOSPD2-expressing cancer cells," said Dror Harats M.D., Chief Executive Officer of VBL Therapeutics. "VBL is well capitalized, with approximately $50 million in cash, which will enable us to continue the development of VB-111 and our deep pipeline through 2020.'
First Quarter and Recent Corporate Highlights:
- Continued to treat patients in the ongoing Phase 3 OVAL trial, studying VB-111 in platinum-resistant ovarian cancer. The OVAL study has been designed to enroll up to 350 adult patients at approximately 70 clinical sites in the U.S. and Israel.
-- The Company is modifying the OVAL protocol to incorporate an efficacy interim readout, which is expected to occur in the fourth quarter of 2019.
- The Company is conducting an in-depth analysis of the GLOBE study, including analysis of patient subgroups, in order to better understand the outcome of the study, the major difference between the Phase II and the GLOBE trial and the potential activity of VB-111 in rGBM.
- Presented late breaking research on the Company's MOSPD2 oncology program at the American Association for Cancer Research (AACR) 2018 annual meeting.
-- The data provide proof-of-concept on the use of a bispecific antibody to kill MOSPD2-expressing cancer cells, with potential applicability to solid tumors and myeloid malignancies.
-- The MOSPD2 program was also featured in a presentation at the 17th MIXiii-BIOMED 2018 Conference and Exhibition, May 15-17 in Tel Aviv, Israel.
-- VBL is developing its VB-600 series of antibodies targeting MOSPD2 for oncology and inflammatory applications.
- Awarded 8.9 million New Israeli Shekels (approximately US$2.5 million) non-dilutive grant by the Israel Innovation Authority (IIA).
-- The funds will support the development of VB-111 as well as the Company's Vascular Targeting System (VTS™) platform for therapeutic gene therapy.
- Appointed two senior pharmaceutical executives, Susan Kelley, M.D., and David Hastings, to its Board of Directors.
First Quarter Ended March 31, 2018 Financial Results:
- Revenues: In 2017 the Company entered into an exclusive license agreement with NanoCarrier Co., Ltd. and received an up-front and a milestone payment of $17.0 million in aggregate, of which $0.2 million was recognized as of March 2018.
- Cash Position: Cash, cash equivalents and short-term bank deposits at March 31, 2018, were $49.9 million. Working capital at March 31 was $44.3 million. The Company expects that the current cash, cash equivalents and short-term bank deposits will be sufficient to fund operating expenses and capital expenditure requirements through 2020.
- R&D Expenses: Research and development expenses for the quarter ended March 31, 2018, were approximately $5.8 million, compared to approximately $4.1 million in the comparable period in 2017. R&D expenses are shown net of IIA grants.
- G&A Expenses: General and administrative expenses for the quarter ended March 31, 2018 were $1.4 million, compared to $1.1 million for the comparable period in 2017.
- Comprehensive Loss: The Company reported a comprehensive loss for first quarter ended March 31, 2018 of $7.2 million, or ($0.24) per share, compared to a net loss of $5.0 million, or ($0.19) per share in first quarter ended March 31, 2017.
Thursday, May 17th @ 8:30am Eastern Time
Replays, Available through May 31, 2018
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. 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|
|March, 31||December, 31|
|U.S. dollars in thousands|
|Cash and cash equivalents||$||8,583||$||6,694|
|Short-term bank deposits||41,306||48,035|
|Other current assets||2,307||1,729|
|TOTAL CURRENT ASSETS||52,196||58,458|
|Property and equipment, net||8,222||7,128|
|Long-term prepaid expenses||64||103|
|TOTAL NON-CURRENT ASSETS||8,286||7,231|
|Liabilities and equity|
|TOTAL CURRENT LIABILITIES||7,921||7,569|
|Severance pay obligations, net||128||128|
|TOTAL NON-CURRENT LIABILITIES||2,220||2,220|
|Accumulated other comprehensive income||16||16|
|Additional paid in capital||222,675||221,055|
|TOTAL LIABILITIES AND EQUITY||$||60,482||$||65,689|
|VASCULAR BIOGENICS LTD.|
|CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE LOSS|
|Three Months Ended March 31,|
|U.S. dollars in thousands|
|COST OF REVENUES||(67||)||-|
|RESEARCH AND DEVELOPMENT EXPENSES, net||$||5,760||$||4,144|
|GENERAL AND ADMINISTRATIVE EXPENSES||1,395||1,105|
|FINANCIAL EXPENSES (INCOME), net||(115||)||(215||)|
|LOSS PER ORDINARY SHARE|
|Basic and diluted||$||0.24||$||0.19|
|Number of shares|
|WEIGHTED AVERAGE ORDINARY SHARES OUTSTANDING-|
|Basic and diluted||29,887,254||26,907,172|
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