| ● | Positive data from the first interim analysis in the OVAL Phase 3 Potential Registration Study of VB-111 in Ovarian Cancer were presented at ASCO20; response rate in the VB-111 treatment arm was 58% or higher | |
| ● | Successful pre-planned second interim analysis in OVAL, with a positive Data Safety Monitoring Committee (DSMC) review looking at overall survival - the primary endpoint of the trial; study to proceed without modification | |
| ● | MOSPD2 program for inflammation: | |
| o | Pre-IND application for VBL’s VB-601 mAb candidate for immune-inflammatory indications was submitted to the FDA in June | |
| o | New data implicating the potential of anti-MOSPD2 antibodies for treatment of nonalcoholic steatohepatitis (NASH) and colitis presented at DDW | |
| o | Preclinical data in RA presented at EULAR 2020 | |
| ● | MOSPD2 program for cancer: | |
| o | New data on bispecific antibodies featured at late breaking abstract session at AACR | |
| ● | Cash position secured into the third quarter of 2022 | |
| ● | Conference Call and Webcast at 8:30am Eastern Time Today | |
TEL AVIV, Israel, Aug. 13, 2020 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT) today announced financial results for the second quarter ended June 30, 2020, and provided a corporate update.
“We have made excellent progress advancing our lead candidate VB-111 during 2020,” said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. “The first interim analysis in our OVAL Phase 3 pivotal study in ovarian cancer demonstrated the potential benefit of VB-111 over standard-of-care in a randomized-controlled study, and the recent positive second interim analysis indicates that the trial continues to be on the right track. OVAL has shown strong recruitment despite the COVID-19 pandemic. Also, when the Company blindly reviews response rate data in all trial participants, that is in the treatment and control groups combined, we are very encouraged by the high response rate of over 50% of the total evaluable patients, which has been maintained. The investigator sponsored studies of VB-111 in GBM and colorectal cancer are headed for initiation. Our MOSPD2 programs are gaining momentum, with pre-IND application for our lead candidate VB-601 for inflammation, and recent scientific presentations in NASH and colitis at DDW, in rheumatoid arthritis at EULAR 2020 and in oncology at the AACR meeting.”
Second Quarter and Recent Key Corporate Highlights:
VB-111
| ● | Efficacy data from first interim analysis in the OVAL were reported in March and presented at the ASCO20 Annual Meeting, showing 58% or higher objective response rate. | |
| o | OVAL independent DSMC reviewed unblinded data and determined that the study has met the interim pre-specified criterion of an absolute percentage advantage of 10% or higher in CA-125 response in the VB-111 treated arm compared to control. The DSMC recommended that the study proceed without modification. | |
| o | Overall response rate in the first 60 randomized evaluable patients was 53%. Assuming a balanced randomization, it can be deduced that the response rate in the treatment arm (VB-111 in addition to weekly paclitaxel) was 58% or higher. | |
| o | In patients with post-treatment fever, the response was 69%. Fever is frequently observed after VB-111 treatment. | |
| ● | Successful second pre-planned interim analysis, with a positive DSMC review of OS data, the primary endpoint of the OVAL Phase 3 potential registration study, was completed on August 11. | |
| o | Independent DSMC reviewed unblinded data of the first 100 patients with follow-up of at least 3 months and determined that the study should proceed without modification. | |
| ● | Two investigator sponsored VB-111 Phase 2 studies, in rGBM, at Dana Farber Cancer Center and other leading neuro-oncology centers, and in metastatic colorectal cancer by the NCI, are on track for initiation. | |
MOSPD2
| ● | Pre-IND application for VBL’s VB-601 mAb for immune-inflammatory indications was submitted to the FDA in June. The application is currently under review by the agency. | |
| ● | Announced new data implicating the potential of its anti-MOSPD2 antibodies for treatment of nonalcoholic steatohepatitis (NASH) and colitis at DDW 2020. | |
| o | Treatment with anti-MOSPD2 antibodies was shown to decrease inflammation and fibrosis in a NASH model and significantly reduce disease activity in a colitis model. VBL’s study was rated in the top 10% of all abstracts in this category and was selected as Poster of Distinction. | |
| ● | Presented new data at the European League Against Rheumatism (EULAR) implicating the potential of proprietary anti-MOSPD2 antibodies for treatment of rheumatoid arthritis (RA). | |
| o | Treatment with anti-MOSPD2 antibodies significantly inhibited arthritis progression in the collagen-induced arthritis model (p<0.005). The treatment reduced >50% of disease severity and blocked further disease progression. | |
| o | Anti-MOSPD2 demonstrated higher activity than anti-TNFa in the advanced phase of the disease. | |
| ● | Published a new manuscript demonstrating the potential of MOSPD2 antibodies in multiple sclerosis (MS). The results add to a growing body of data demonstrated activity of VBL’s antibodies in models of chronic inflammatory disease. | |
| ● | Presented new data demonstrating the potential of anti-MOSPD2 immune-mediated targeting of solid tumors at the Annual American Association for Cancer Research (AACR) Virtual Annual Meeting II. | |
| o | MOSPD2 bi-specific antibody candidates induced T-cell activation and significantly extended the survival of animals carrying established metastatic cervical and breast cancer. | |
| o | The data presented demonstrated that the bi-specific antibody candidates mediated killing of tumor cells by CD8 T-cells in a dose-dependent manner and induced T-cell activation in-vivo. | |
VB-201
| ● | The world-leading European animal health company partner, that is evaluating VB-201 for veterinary applications, advised that the program met a pre-determined milestone. This triggered an undisclosed cash payment to VBL. |
Corporate:
| ● | Raised $18.1 million of gross proceeds in two registered direct offerings |
| ● | Awarded a non-dilutive grant of up to 3.175 million New Israeli Shekels (NIS; approximately $0.9 million) by the Israel Innovation Authority (IIA). |
Quarter Ended June 30, 2020 Financial Results:
| ● | Cash Position: At June 30, 2020, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposit totaling $41.3 million and working capital of $36.1 million. VBL expects that its cash and cash equivalents and short-term bank deposits will be sufficient to fund operating expenses and capital expenditure requirements into the third quarter of 2022. |
| ● | Revenue: Revenues for the second quarter, 2020 were $158 thousand, compared to $138 thousand for the comparable period in 2019. |
| ● | Research and Development Expenses: Research and Development expenses, net, were approximately $4.9 million for the second quarter, compared to approximately $3.7 million in the comparable period of 2019. |
| ● | General and Administrative Expenses: General and administrative expenses for the second quarter were $1.1 million, compared to $1.2 million for the same period of 2019. |
| ● | Comprehensive Loss: VBL reported a net loss for three-month period ended June 30, 2020 of $5.8 million, or ($0.14) per diluted share, compared to a net loss of $4.7 million, or ($0.13) per diluted share, in the same period of 2019. |
For further details on VBL’s financials, please refer to Form 6-k filed with the SEC.
Conference Call:
Thursday, August 13 @ 8:30amET
| From the US: | 877-407-9208 | |
| International: | 201-493-6784 | |
| Israel local Number: | 1-809-406-247 | |
| Conference ID: | 13707066 | |
| Webcast: | https://edge.media-server.com/mmc/p/y7tts2sv |
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 areas of unmet need in cancer and immune/inflammatory indications.
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 may include, but are not limited to, statements regarding our programs, including VB-111, VB-600, including their clinical development, therapeutic potential, the impact of the COVID-19 pandemic on VBL's business, operations, clinical trials, supply chain, strategy, goals and anticipated timelines 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 market and other conditions, 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. In particular, the DSMC recommendation that the OVAL trial proceed is not assurance that the trial will meet its primary endpoint of overall survival once completed. 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, 2019, 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, except as required by law.
INVESTOR CONTACT:
Michael Rice
LifeSci Advisors
(646) 597-6979
VASCULAR BIOGENICS LTD.
CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION
(UNAUDITED)
| June 30, 2020 | December 31, 2019 | |||||||
| U.S. dollars in thousands | ||||||||
| Assets | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 16,702 | $ | 9,436 | ||||
| Short-term bank deposits | 24,045 | 27,100 | ||||||
| Short-term restricted bank deposits | 153 | - | ||||||
| Trade Receivables | 118 | - | ||||||
| Other current assets | 1,703 | 1,242 | ||||||
| TOTAL CURRENT ASSETS | 42,721 | 37,778 | ||||||
| NON-CURRENT ASSETS: | ||||||||
| Restricted bank deposits | 358 | 506 | ||||||
| Property and equipment, net | 6,455 | 6,949 | ||||||
| Right-of-use assets | 2,840 | 3,088 | ||||||
| Long-term prepaid expenses | 300 | 300 | ||||||
| TOTAL NON-CURRENT ASSETS | 9,953 | 10,843 | ||||||
| TOTAL ASSETS | $ | 52,674 | $ | 48,621 | ||||
| Liabilities and equity | ||||||||
| CURRENT LIABILITIES- | ||||||||
| Accounts payable and accruals: | ||||||||
| Trade | $ | 2,241 | $ | 3,330 | ||||
| Other | 3,247 | 4,238 | ||||||
| Deferred revenue | 533 | 386 | ||||||
| Lease liabilities | 641 | 774 | ||||||
| TOTAL CURRENT LIABILITIES | 6,662 | 8,728 | ||||||
| NON-CURRENT LIABILITIES- | ||||||||
| Severance pay obligations, net | 163 | 163 | ||||||
| Deferred revenue | 1,283 | 1,723 | ||||||
| Other non-current liability | 82 | - | ||||||
| Lease liabilities | 1,946 | 2,167 | ||||||
| TOTAL NON-CURRENT LIABILITIES | 3,474 | 4,053 | ||||||
| TOTAL LIABILITIES | 10,136 | 12,781 | ||||||
| SHAREHOLDERS’ EQUITY: | ||||||||
| Ordinary shares, NIS 0.01 par value; Authorized as of June 30, 2020 and December 31, 2019, 70,000,000 shares; issued and outstanding as of June 30, 2020 and December 31, 2019, 47,896,736 and 35,882,928 shares, respectively | 108 | 73 | ||||||
| Accumulated other comprehensive income | (8 | ) | (8 | ) | ||||
| Additional paid in capital | 251,331 | 235,974 | ||||||
| Warrants | 10,401 | 7,904 | ||||||
| Accumulated deficit | (219,294 | ) | (208,103 | ) | ||||
| TOTAL SHAREHOLDERS’ EQUITY | 42,538 | 35,840 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ | 52,674 | $ | 48,621 | ||||
| The accompanying notes are an integral part of the financial statements. |
VASCULAR BIOGENICS LTD.
CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(UNAUDITED)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| U.S. dollars in thousands | ||||||||||||||||
| REVENUES | $ | 158 | $ | 138 | $ | 524 | $ | 357 | ||||||||
| COST OF REVENUES | (60 | ) | (50 | ) | (113 | ) | (88 | ) | ||||||||
| GROSS PROFIT | 98 | 88 | 411 | 269 | ||||||||||||
| RESEARCH AND DEVELOPMENT EXPENSES, net | $ | 4,865 | $ | 3,729 | $ | 9,616 | $ | 7,037 | ||||||||
| GENERAL AND ADMINISTRATIVE EXPENSES | 1,074 | 1,181 | 2,242 | 2,437 | ||||||||||||
| OPERATING LOSS | 5,841 | 4,822 | 11,447 | 9,205 | ||||||||||||
| FINANCIAL INCOME | (37 | ) | (223 | ) | (329 | ) | (499 | ) | ||||||||
| FINANCIAL EXPENSES | 34 | 91 | 73 | 166 | ||||||||||||
| FINANCIAL INCOME, net | (3 | ) | (132 | ) | (256 | ) | (333 | ) | ||||||||
| COMPREHENSIVE LOSS | $ | 5,838 | $ | 4,690 | $ | 11,191 | $ | 8,872 | ||||||||
| LOSS PER ORDINARY SHARE | U.S. dollars | |||||||||||||||
| Basic and diluted | $ | 0.14 | $ | 0.13 | $ | 0.28 | $ | 0.25 | ||||||||
| Number of shares | ||||||||||||||||
| WEIGHTED AVERAGE ORDINARY SHARES OUTSTANDING- | ||||||||||||||||
| Basic and diluted | 42,674,526 | 35,881,128 | 39,354,355 | 35,881,128 | ||||||||||||
The accompanying notes are an integral part of the condensed financial statements.