VBLT - VBL Therapeutics Announces Second Quarter 2019 Financial Results
TEL AVIV, Israel, Aug. 13, 2019 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: 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:
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| 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. |
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| 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). |
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| 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. |
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| 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. |
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| 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. |
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| 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:
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| 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. |
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| Revenues: Revenues related to VBL’s collaborations were $0.1 million in the second quarter of 2019. |
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| 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. |
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| 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. |
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| 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 |