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VBL Therapeutics Announces Second Quarter 2019 Financial Results

Conference Call and Webcast at 8:30am Eastern Time Today

TEL AVIV, Israel, Aug. 13, 2019 (GLOBE NEWSWIRE) -- VBL Therapeutics (VBLT) today announced financial results for the second quarter ended June 30, 2019, and provided a corporate update.

“Our OVAL Phase 3 potential-registration trial of VB-111 in ovarian cancer continues as planned,” said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. “The final results from the prior Phase 2 study (presented at ASCO in June) which show statistically significant prolongation of overall survival in platinum-resistant patients, strengthen our belief in the potential of VB-111. An important outcome from Phase 2 was the correlation between CA-125 response and survival benefit. Measurement of CA-125 will, therefore, be the focus of our interim analysis in OVAL, planned for year-end 2019.”

Second Quarter and Recent Corporate Highlights:

      Two posters on VB-111, in platinum resistant ovarian cancer and in recurrent glioblastoma multiforme (rGBM), were featured at the American Society of Clinical Oncology (ASCO) 2019 Annual Meeting, held in June 2019 in Chicago.
    °   Final data from the prior Phase 2 study in ovarian cancer demonstrated a statistically significant dose dependent increase in median overall survival in patients treated with therapeutic dose vs. low dose of VB-111 (498 days vs. 172.5 days, p=0.03).
    °   CA-125 biomarker response (GCIG) was reported in 58% of evaluable patients and was predictive of median overall survival (808 days vs. 351 days) in ovarian cancer, in patients treated with a therapeutic dose of VB-111.
    °   Post treatment tumor infiltrating CD8 T-cells and apoptotic cancer cells indicated tumor transformation from immunologically ‘cold’ to ‘hot’, possibly contributing to the favorable clinical outcomes in ovarian cancer.
    °   Results were presented from a radiographic analysis conducted at the Brain Tumor Imaging Laboratory at UCLA of the Phase 2 and Phase 3 trials of VB-111 in rGBM. This analysis provides independent, quantitative data that priming with VB-111 results in clinically-meaningful activity in rGBM, which can be seen by MRI signature, demonstrates objective response to VB-111 and is correlated with a statistically significant survival advantage.
    °   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 approval is expected to support future commercialization of VB-111.

Second Quarter ended June 30, 2019 Financial Results:

    Cash Position: At June 30, 2019, the Company had cash, cash equivalents and short-term bank deposits totaling $45.1 million and working capital of $39.1 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 at least two years.
    Revenues: Revenues related to VBL’s collaborations were $0.1 million in the second quarter of 2019.
    R&D Expenses: Research and development expenses, net, after government grants, for the quarter ended June 30, 2019, were approximately $3.7 million, compared to approximately $2.9 million in the same period in 2018.
    G&A Expenses: General and administrative expenses for the quarter ended June 30, 2019 were $1.2 million, as in the same period in 2018.
    Comprehensive Loss: VBL reported a net loss for the quarter ended June 30, 2019 of $4.7 million, or ($0.13) per share, compared to a net loss of $4.1 million, or ($0.13) per share, in the quarter ended June 30, 2018.

For further details on VBL’s financials, please refer to Form 6-K filed with the SEC.

Conference Call:

Tuesday, August 13th @ 8:30am Eastern Time

From the US: 877-407-9208
International: 201-493-6784
Conference ID: 13692422
Webcast: Webcast

About VBL

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. VBL’s lead oncology product candidate, ofranergene obadenovec (VB-111), is a first-in-class, targeted anti-cancer gene-therapy agent that is being developed 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 activity 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 potential registration 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 our programs, including VB-111, including their clinical development, such as the timing of clinical trials and expected announcement of data, therapeutic potential and clinical results, and our financial position and cash runway. 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, the risk that historical clinical trial results may not be predictive of future trial results, that our financial resources do not last for as long as anticipated, and that we may not realize the expected benefits of our intellectual property protection. A further list and description of these risks, uncertainties and other risks can be found in our 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, 2018, 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.

INVESTOR CONTACT:

Michael Rice
LifeSci Advisors
mrice@lifesciadvisors.com
(646) 597-6979


VASCULAR BIOGENICS LTD.

CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION
(UNAUDITED)

  June 30, 2019     December 31, 2018  
           
  U.S. dollars in thousands  
Assets          
CURRENT ASSETS:              
Cash and cash equivalents $ 8,282     $ 29,347  
Short-term bank deposits   36,854       21,135  
Other current assets   1,206       1,227  
TOTAL CURRENT ASSETS   46,342       51,709  
               
NON-CURRENT ASSETS:              
Property and equipment, net   7,461       8,921  
Right-of-use assets   3,418       -  
Long-term prepaid expenses   -       48  
TOTAL NON-CURRENT ASSETS   10,879       8,969  
TOTAL ASSETS $ 57,221     $ 60,678  
               
Liabilities and equity              
CURRENT LIABILITIES-              
Accounts payable:              
Trade $ 2,099     $ 1,193  
Other   3,967       2,944  
Deferred revenue   321       290  
Lease liabilities   793       347  
TOTAL CURRENT LIABILITIES   7,180       4,774  
               
NON-CURRENT LIABILITIES-              
Severance pay obligations, net   104       99  
Deferred revenue   1,993       2,263  
Lease liabilities   2,459       449  
TOTAL NON-CURRENT LIABILITIES   4,556       2,811  
TOTAL LIABILITIES   11,736       7,585  
               
EQUITY:              
Ordinary shares   73       73  
Accumulated other comprehensive income   41       41  
Additional paid in capital   234,985       233,721  
Warrants   7,904       7,904  
Accumulated deficit   (197,518 )     (188,646 )
TOTAL EQUITY   45,485       53,093  
TOTAL LIABILITIES AND EQUITY $ 57,221     $ 60,678  
               


VASCULAR BIOGENICS LTD.

CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE LOSS

(UNAUDITED)

  Three Months Ended June 30,     Six Months Ended June 30,  
  2019     2018     2019     2018  
                       
  U.S. dollars in thousands  
REVENUES $ 138     $ 180     $ 357     $ 343  
COST OF REVENUES   (50 )     (77 )     (88 )     (144 )
GROSS PROFIT   88       103       269       199  
RESEARCH AND DEVELOPMENT EXPENSES, net $ 3,729     $ 2,895     $ 7,037     $ 8,655  
MARKETING EXPENSES   -       189       -       424  
GENERAL AND ADMINISTRATIVE EXPENSES   1,181       1,171       2,437       2,566  
OPERATING LOSS   4,822       4,152       9,205       11,446  
FINANCIAL INCOME   (223 )     (108 )     (499 )     (253 )
FINANCIAL EXPENSES   91       10       166       40  
FINANCIAL INCOME, net   (132 )     (98 )     (333 )     (213 )
COMPREHENSIVE LOSS $ 4,690     $ 4,054     $ 8,872     $ 11,233  


LOSS PER ORDINARY SHARE U.S. dollars  
                               
Basic and diluted $ 0.13     $ 0.13     $ 0.25     $ 0.37  


  Number of shares  
WEIGHTED AVERAGE ORDINARY SHARES OUTSTANDING-                              
Basic and diluted   35,881,128       30,147,505       35,881,128       30,017,020