Investor Relations

VBL Therapeutics Announces Third Quarter 2019 Financial Results

November 14, 2019
Conference Call and Webcast at 8:30am Eastern Time Today

TEL AVIV, Israel, Nov. 14, 2019 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT) today announced financial results for the third quarter ended September 30, 2019, and provided a corporate update.

“Our OVAL Phase 3 potential-registration trial of VB-111 in ovarian cancer is progressing well and we look forward to an important interim analysis expected in the first quarter of 2020,” said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. “The interim analysis will be based on CA-125 response, a disease marker which correlated with survival benefit in our Phase 2 study in platinum-resistant ovarian cancer patients. We also look forward to the launch of an investigator-sponsored trial of VB-111 in recurrent GBM and an NCI-sponsored trial in colon cancer, expected before the end of 2019.”

Third Quarter and Recent Corporate Highlights:

  • An investigational new drug (IND) application for an investigator-sponsored Phase 2 trial of VB-111 in recurrent glioblastoma (“rGBM”) went into effect with the U.S. Food and Drug Administration (FDA). The IND was submitted by Dana-Farber Cancer Institute, on behalf of a group of top neuro-oncology US medical centers. Further details on the trial will be presented at the upcoming Annual Meeting and Education Day of the Society for Neuro-Oncology, to take place November 20 - 24, 2019 at the Marriott Desert Ridge Hotel, Phoenix, Arizona.

  • An NCI-sponsored trial of VB-111 in colon cancer is expected to begin by year-end 2019. Based on the potential of VB-111 to turn immunologically “cold” tumors “hot”, as seen in ovarian cancer biopsies, the new study will evaluate for the first time a combination of VB-111 and a checkpoint inhibitor in colon cancer, a cold tumor in which checkpoints inhibitor are ineffective for the vast majority of patients. 

  • 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 step is expected to support future commercialization of VB-111, if approved.

  • VBL continues to advance the development of lead MOSPD2 antibodies towards IND applications in inflammation and in oncology, expected by year-end 2020. The Company has signed a service agreement with Thermo Fisher Scientific, one of the leading vendors in the antibody field, for production of lead candidate VB-601 for toxicology and clinical development.

Third Quarter ended September 30, 2019 Financial Results:

  • Cash Position: At September 30, 2019, the Company had cash, cash equivalents, short-term bank deposits and restricted bank deposits totaling $41.1 million and working capital of $34.5 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 approximately two years.

  • Revenues: Revenues related to VBL’s collaborations were $0.1 million in the third quarter of 2019.

  • R&D Expenses: Research and development expenses, net, after government grants, were approximately $3.8 million for the quarter ended September 30, 2019, compared to approximately $4.1 million in the same period in 2018.

  • G&A Expenses: General and administrative expenses for the quarter ended September 30, 2019 were $1.2 million, compared to approximately $1.4 million in the same period in 2018.

  • Comprehensive Loss: VBL reported a net loss for the quarter ended September 30, 2019 of $4.9 million, or ($0.14) per share, compared to a net loss of $5.4 million, or ($0.15) per share, in the quarter ended September 30, 2018.

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

Conference Call: Thursday, November 14th @ 8:30am Eastern Time

From the US: 877-407-9208
International: 201-493-6784
Conference ID: 13696234
Webcast: https://edge.media-server.com/mmc/p/2s8reh2m 

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 and immune-inflammatory indications. 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, 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)

    September 30,
2019
    December 31,
2018
 
       
    U.S. dollars in thousands  
Assets                
CURRENT ASSETS:                
Cash and cash equivalents   $ 22,319     $ 29,347  
Short-term bank deposits     18,231       21,135  
Other current assets     1,636       1,227  
TOTAL CURRENT ASSETS     42,186       51,709  
                 
NON-CURRENT ASSETS:                
Restricted bank deposits     503       -  
Property and equipment, net     7,197       8,921  
Right-of-use assets     3,253       -  
Long-term prepaid expenses     -       48  
TOTAL NON-CURRENT ASSETS     10,953       8,969  
TOTAL ASSETS   $ 53,139     $ 60,678  
                 
Liabilities and equity                
CURRENT LIABILITIES-                
Accounts payable and accruals:                
Trade   $ 1,263     $ 1,193  
Other     5,256       2,944  
Deferred revenue     377       290  
Lease liabilities     791       347  
TOTAL CURRENT LIABILITIES     7,687       4,774  
                 
NON-CURRENT LIABILITIES-                
Severance pay obligations, net     106       99  
Deferred revenue     1,858       2,263  
Lease liabilities     2,333       449  
TOTAL NON-CURRENT LIABILITIES     4,297       2,811  
TOTAL LIABILITIES     11,984       7,585  
                 
EQUITY:                
Ordinary shares     73       73  
Accumulated other comprehensive income     41       41  
Additional paid in capital     235,511       233,721  
Warrants     7,904       7,904  
Accumulated deficit     (202,374 )     (188,646 )
TOTAL EQUITY     41,155       53,093  
TOTAL LIABILITIES AND EQUITY   $ 53,139     $ 60,678  
                 


VASCULAR BIOGENICS LTD.

CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE LOSS

(UNAUDITED)

    Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
    2019     2018     2019     2018  
       
    U.S. dollars in thousands  
REVENUES   $ 79     $ 101     $ 436     $ 444  
COST OF REVENUES     (30 )     (44 )     (118 )     (188 )
GROSS PROFIT     49       57       318       256  
RESEARCH AND DEVELOPMENT EXPENSES, net   $ 3,795     $ 4,137     $ 10,832     $ 12,792  
MARKETING EXPENSES     -       151       -       575  
GENERAL AND ADMINISTRATIVE EXPENSES     1,232       1,406       3,669       3,972  
OPERATING LOSS     4,978       5,637       14,183       17,083  
FINANCIAL INCOME     (223 )     (387 )     (722 )     (640 )
FINANCIAL EXPENSES     101       102       267       142  
FINANCIAL INCOME, net     (122 )     (285 )     (455 )     (498 )
COMPREHENSIVE LOSS   $ 4,856     $ 5,352     $ 13,728     $ 16,585  
       
LOSS PER ORDINARY SHARE   U.S. dollars  
                         
Basic and diluted   $ 0.14     $ 0.15     $ 0.38     $ 0.52  
       
    Number of shares  
WEIGHTED AVERAGE ORDINARY SHARES OUTSTANDING-                        
Basic and diluted     35,881,128       35,865,050       35,881,128       31,987,750  
                                 

 

VBL Logo.jpg