TEL AVIV, Israel, May 14, 2020 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT) today announced financial results for the first quarter ended March 31, 2020, and provided a corporate update.
“We reached an important milestone in our development of VB-111 in ovarian cancer with the recent positive outcome of the interim analysis of the ongoing Phase 3 OVAL study, which demonstrated the potential benefit of VB-111 over standard-of-care in a randomized-controlled study,” said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. “A second planned interim analysis which will assess overall survival in the two treatment arms, is expected in the third quarter this year. We are pleased to be making progress also in our MOSPD2 antibody programs. We recently presented promising new data in NASH and colitis models in a Poster of Distinction at Digestive Disease Week, and also published a peer review manuscript on the potential of MOSPD2 antibodies to treat multiple sclerosis (MS). New data on our MOSPD2 bi-specific antibodies will be presented in a late breaking session at the upcoming American Association for Cancer Research (AACR) annual meeting in June. Based on these positive developments, we successfully raised additional $18.1 million in gross proceeds, in spite of the COVID-19 pandemic complexities. Our current cash position is expected to fund our operations into the third quarter of 2022.”
First Quarter and Key Corporate Highlights:
VB-111:
| ● | The independent Data Safety Monitoring Committee (DSMC) reviewed un-blinded data from the ongoing OVAL study in ovarian cancer 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. |
| ● | The overall CA-125 response rate in the first 60 randomized evaluable patients is 53%. Assuming a balanced randomization, the response rate in the treatment arm (VB-111 in addition to weekly paclitaxel) is 58% or higher. In patients who had post-dosing fever, which is a marker for VB-111 treatment, the response rate is 69%. |
| ● | The CA-125 response rate observed in the Phase 3 interim analysis is at least as good as the response rate seen in Phase 2, which enrolled similar population of patients with platinum-resistant ovarian cancer. The results will be presented at ASCO20 Virtual Scientific Program. |
| ● | The OVAL interim analysis results were discussed by Dr. Bradley J. Monk of Arizona Oncology on a KOL call hosted by the Company on March 26. |
| ● | NanoCarrier Co., Ltd., the Japanese licensee for VB-111, announced its intention to extend the ongoing global Phase 3 OVAL clinical trial in ovarian cancer to patients in Japan. |
| ● | The Israel Innovation Authority (IIA) awarded a non-dilutive grant of up to 3.175 million New Israeli Shekels (NIS) (approximately $0.9 million) to fund development of VB-111. |
| ● | The planned studies of VB-111 in metastatic colorectal cancer and GBM are expected to start patient recruitment as soon as the COVID-19 situation allows. |
MOSPD2:
| ● | Published a new peer review manuscript demonstrating the potential of MOSPD2 antibodies for multiple sclerosis (MS). | |
| ○ | VBL's data offer a differentiated approach to potential treatment of relapsing as well as progressive MS disease | |
| ● | New preclinical data on MOSPD2 antibodies for treatment of NASH and colitis were presented at Digestive Disease Week (DDW). | |
| ○ | Data demonstrate the potential of VBL's proprietary MOSPD2 mAbs for chronic inflammatory indications, via a novel and distinct mechanism targeting monocyte migration | |
| ○ | The study was rated in the top 10% of all abstracts in this category and was selected as Poster of Distinction | |
VB-201:
| ● | A milestone event was reached under VBL’s collaborative agreement with a world-leading European animal health company, evaluating use of VB-201 for veterinary applications. |
Quarter Ended March 31, 2020 Financial Results:
| ● | Cash Position: At March 31, 2020, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposits totaling $31.6 million and working capital of $24.6 million. VBL expects that its cash and cash equivalents and short-term bank deposits with the addition approximately $16.7 million from the net proceeds of the Registered Direct Offerings of which we have announced on May 7, 2020 and on May 11, 2020, will be sufficient to fund operating expenses and capital expenditure requirements into the third quarter of 2022. |
| ● | Revenues: Revenues for the three-month period ended March 31, 2020 were $366 thousand, compared to $219 thousand in the same period of 2019. |
| ● | R&D Expenses: Research and development expenses, net, after government grants, in the three-month period ended March 31, 2020, were $4.8 million, compared to $3.3 million in the same period in 2019. |
| ● | G&A Expenses: General, administrative and marketing expenses for the three-month period ended March 31, 2020, were $1.2 million, compared to the $1.3 million in the same period in 2019. |
| ● | Comprehensive Loss: VBL reported a net loss for three-month period ended March 31, 2020 of $5.4 million, or ($0.15) per diluted share, compared to a net loss of $4.2 million, or ($0.12) 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 May 14th @ 8:30amET
| From the US: | 877-407-9208 |
| International: | 201-493-6784 |
| Israel: | 1 809 406 247 |
| Conference ID: | 13703295 |
| Webcast: | https://edge.media-server.com/mmc/p/ubiyng5a |
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 our 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)
| March 31, 2020 | December 31, 2019 | |||||||
| U.S. dollars in thousands | ||||||||
| Assets | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 12,935 | $ | 9,436 | ||||
| Short-term bank deposits | 18,139 | 27,100 | ||||||
| Trade Receivables | 230 | - | ||||||
| Other current assets | 1,248 | 1,242 | ||||||
| TOTAL CURRENT ASSETS | 32,552 | 37,778 | ||||||
| NON-CURRENT ASSETS: | ||||||||
| Restricted bank deposits | 508 | 506 | ||||||
| Property and equipment, net | 6,701 | 6,949 | ||||||
| Right-of-use assets | 2,994 | 3,088 | ||||||
| Long-term prepaid expenses | 300 | 300 | ||||||
| TOTAL NON-CURRENT ASSETS | 10,503 | 10,843 | ||||||
| TOTAL ASSETS | $ | 43,055 | $ | 48,621 | ||||
| Liabilities and equity | ||||||||
| CURRENT LIABILITIES- | ||||||||
| Accounts payable and accruals: | ||||||||
| Trade | $ | 2,292 | $ | 3,330 | ||||
| Other | 4,423 | 4,238 | ||||||
| Deferred revenue | 451 | 386 | ||||||
| Lease liabilities | 747 | 774 | ||||||
| TOTAL CURRENT LIABILITIES | 7,913 | 8,728 | ||||||
| NON-CURRENT LIABILITIES- | ||||||||
| Severance pay obligations, net | 158 | 163 | ||||||
| Deferred revenue | 1,521 | 1,723 | ||||||
| Other non-current liability | 62 | - | ||||||
| Lease liabilities | 1,965 | 2,167 | ||||||
| TOTAL NON-CURRENT LIABILITIES | 3,706 | 4,053 | ||||||
| TOTAL LIABILITIES | 11,619 | 12,781 | ||||||
| SHAREHOLDERS’ EQUITY: | ||||||||
| Ordinary shares | 75 | 73 | ||||||
| Accumulated other comprehensive income | (8 | ) | (8 | ) | ||||
| Additional paid in capital | 238,737 | 235,974 | ||||||
| Warrants | 6,088 | 7,904 | ||||||
| Accumulated deficit | (213,456 | ) | (208,103 | ) | ||||
| TOTAL SHAREHOLDERS’ EQUITY | 31,436 | 35,840 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ | 43,055 | $ | 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 March 31, | ||||||||
| 2020 | 2019 | |||||||
| U.S. dollars in thousands | ||||||||
| REVENUES | $ | 366 | $ | 219 | ||||
| COST OF REVENUES | (53 | ) | (38 | ) | ||||
| GROSS PROFIT | 313 | 181 | ||||||
| RESEARCH AND DEVELOPMENT EXPENSES, net | $ | 4,751 | $ | 3,308 | ||||
| GENERAL AND ADMINISTRATIVE EXPENSES | 1,168 | 1,256 | ||||||
| OPERATING LOSS | 5,606 | 4,383 | ||||||
| FINANCIAL INCOME | (292 | ) | (276 | ) | ||||
| FINANCIAL EXPENSES | 39 | 75 | ||||||
| FINANCIAL INCOME, net | (253 | ) | (201 | ) | ||||
| COMPREHENSIVE LOSS | $ | 5,353 | $ | 4,182 | ||||
| LOSS PER ORDINARY SHARE | U.S. dollars | |||||||
| Basic and diluted | $ | 0.15 | $ | 0.12 | ||||
| Number of shares | ||||||||
| WEIGHTED AVERAGE ORDINARY SHARES OUTSTANDING- | ||||||||
| Basic and diluted | 36,103,500 | 35,881,128 | ||||||