TEL AVIV, Israel, Nov. 20, 2018 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT) today announced financial results for the third quarter ended September 30, 2018 and provided a corporate update.
“We continue the development of our novel anticancer drug VB-111, as we enroll and treat patients in the ongoing Phase 3 OVAL trial in platinum resistant ovarian cancer while exploring the opportunity to develop it in other indications,” said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. “We are excited about the potential of our MOSPD2-targeting platform and are advancing two parallel programs exploring MOSPD2 as a therapeutic target in both oncology and inflammatory disease.”
“VBL is well capitalized with more than $53 million in cash and equivalents at September 30, 2018. We believe this will be sufficient to support our Phase 3 clinical trial for VB-111 for ovarian cancer, and advance our pipeline, including the VB-600 platform targeting MOSPD2, for at least the next three years,” concluded Dr. Harats.
Third Quarter and Recent Corporate Highlights:
- Continued to treat patients in the ongoing Phase 3 OVAL trial, evaluating VB-111 in platinum-resistant ovarian cancer.
° OVAL is evaluating VB-111 in combination with chemotherapy, without any change from the regimen which demonstrated overall survival (OS) benefit in the Phase 2 study for ovarian cancer.
° An efficacy interim readout is expected to occur in the fourth quarter of 2019.
° Data on the immune mechanism of VB-111 in platinum resistant ovarian cancer will be presented in March 2019 at the 50th Annual Meeting conference of the Society of Gynecologic Oncology (SGO) in Hawaii. - Presented new analysis from the Phase 3 GLOBE study of VB-111 in patients with recurrent glioblastoma at the 2018 Society for Neuro-Oncology (SNO) annual meeting.
- VBL is developing two independent platforms of proprietary monoclonal antibodies targeting MOSPD2; one for inflammatory indications using classical antibodies, and a second, separate platform for oncology indications, based on bi-specific antibodies.
- Presented new data on the Company’s MOSPD2 oncology program:
° In July 2018, a paper published in the International Journal of Cancer featured VBL data showing that MOSPD2 can play a major role in breast cancer cell migration and metastasis, and that targeting MOSPD2 may be a viable therapeutic strategy to prevent the spreading of breast cancer cells.
° Previously, at the American Association for Cancer Research (AACR) 2018 annual meeting, the Company presented a late-breaking study demonstrating a novel bi-specific antibody that induces immune-cell mediated killing of cancer cells through binding to MOSPD2. - Presented new data on the Company’s MOSPD2 inflammatory disease program:
° At the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), VBL presented data demonstrating that MOSPD2 is essential for the disease development and progression in the experimental autoimmune encephalomyelitis (EAE) model for multiple sclerosis. VBL's proprietary monoclonal antibodies were successfully used both to prevent development, as well as to treat EAE once symptoms had appeared. - Published positive new data on Lecinoxoid drug candidates for the treatment of renal fibrosis in Basic and Clinical Pharmacology and Toxicology.
° The paper published in Basic and Clinical Pharmacology and Toxicology describes the role of the Company’s lecinoxoid drug candidates, VB-201 and VB-703, in slowing the decline of kidney function in renal fibrosis.
° Recently granted US patent provides patent protection for lecinoxoids treatment of liver and renal fibrosis until at least November 2035 and supports potential partnering opportunities. - Continued to strengthen the Company’s intellectual property portfolio - European Patent Office issued Patent No. 2908865, extending exclusive protection for VB-111 until October 2033, before any further potential extension. Similar VB-111 composition-of-matter patents have also been granted in the US, Japan, China and additional countries.
- Strengthened the Board of Directors with the appointment of Dr. Shmuel (“Muli”) Ben Zvi, a well-known pharmaceutical executive in Israel and former senior manager at Teva Pharmaceuticals Industries Ltd.
Third quarter Ended September 30, 2018 Financial Results:
- Revenues: Revenues related to the Company’s collaboration in Japan amounted to $0.1 million in the third quarter ended September 30, 2018.
- Cash Position: Cash, cash equivalents and short-term bank deposits at September 30, 2018, were $53.7 million and working capital was $50.1 million. The Company estimates that, based on current projections, the current cash, cash equivalents and short-term bank deposits will be sufficient to fund operating expenses and capital expenditure requirements for more than 3 years and is expected to be sufficient to support the Company’s Phase 3 clinical trial for VB-111 for ovarian cancer, and to advance its pipeline, including the VB-600 platform targeting MOSPD2 during this period.
- R&D Expenses: Research and development expenses for the quarter ended September 30, 2018, were approximately $4.1 million, compared to approximately $4.8 million in the comparable period in 2017.
- G&A Expenses: General and administrative expenses for the quarter ended September 30, 2018 were $1.4 million, compared to $1.7 million for the comparable period in 2017.
- Comprehensive Loss: The Company reported a comprehensive loss for third quarter ended September 30, 2018 of $5.4 million, or ($0.15) per share, compared to a net loss of $6.5 million, or ($0.24) per share in third quarter ended September 30, 2017.
For further details on VBL’s financials, including the results for the nine month period ended September 30 2018, refer to Form 6-K filed with the S.E.C.
| Conference Call: | |
| Tuesday, November 20th @ 8:30am Eastern Time | |
| US Domestic: | 888-204-4368 |
| International: | 323-994-2082 |
| Conference ID: | 4933637 |
| Webcast: | https://edge.media-server.com/m6/p/8msiqma9 |
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. The Company’s lead oncology product candidate, ofranergene obadenovec (VB-111), is a first-in-class, targeted anti-cancer gene-therapy agent that is positioned 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 efficacy 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 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 lecinoxoids and VB-600, including their clinical development, therapeutic potential and clinical results, our financial position and cash runway, and patent protection for our product candidates. 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, 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 the Company’s 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, 2017, 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, 2018 | December 31, 2017 | |||||
| U.S. dollars in thousands | ||||||
| Assets | ||||||
| CURRENT ASSETS: | ||||||
| Cash and cash equivalents | $ | 8,466 | $ | 6,694 | ||
| Short-term bank deposits | 45,252 | 48,035 | ||||
| Trade receivables | - | 2,000 | ||||
| Other current assets | 1,213 | 1,729 | ||||
| TOTAL CURRENT ASSETS | 54,931 | 58,458 | ||||
| NON-CURRENT ASSETS: | ||||||
| Property and equipment, net | 9,211 | 7,128 | ||||
| Long-term prepaid expenses | 50 | 103 | ||||
| TOTAL NON-CURRENT ASSETS | 9,261 | 7,231 | ||||
| TOTAL ASSETS | $ | 64,192 | $ | 65,689 | ||
| Liabilities and equity | ||||||
| CURRENT LIABILITIES- | ||||||
| Accounts payable: | ||||||
| Trade | $ | 1,668 | $ | 3,058 | ||
| Other | 2,164 | 3,465 | ||||
| Deferred revenue | 606 | 1,046 | ||||
| Lease liability | 356 | - | ||||
| TOTAL CURRENT LIABILITIES | 4,794 | 7,569 | ||||
| NON-CURRENT LIABILITIES- | ||||||
| Severance pay obligations, net | 122 | 128 | ||||
| Deferred revenue | 2,092 | 2,092 | ||||
| Lease liability | 555 | - | ||||
| TOTAL NON-CURRENT LIABILITIES | 2,769 | 2,220 | ||||
| TOTAL LIABILITIES | 7,563 | 9,789 | ||||
| EQUITY: | ||||||
| Ordinary shares | 73 | 57 | ||||
| Accumulated other comprehensive income | 16 | 16 | ||||
| Additional paid in capital | 233,409 | 221,055 | ||||
| Warrants | 7,904 | 2,960 | ||||
| Accumulated deficit | (184,773 | ) | (168,188 | ) | ||
| TOTAL EQUITY | 56,629 | 55,900 | ||||
| TOTAL LIABILITIES AND EQUITY | $ | 64,192 | $ | 65,689 | ||
| VASCULAR BIOGENICS LTD. | ||||||||||||||
| CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE LOSS | ||||||||||||||
| (UNAUDITED) | ||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||
| U.S. dollars in thousands | ||||||||||||||
| REVENUES | $ | 101 | $ | - | $ | 444 | $ | - | ||||||
| COST OF REVENUES | (44 | ) | - | (188 | ) | - | ||||||||
| GROSS PROFIT | 57 | - | 256 | - | ||||||||||
| RESEARCH AND DEVELOPMENT EXPENSES, net | $ | 4,137 | $ | 4,753 | $ | 12,792 | $ | 12,106 | ||||||
| MARKETING EXPENSES | 151 | - | 575 | - | ||||||||||
| GENERAL AND ADMINISTRATIVE EXPENSES | 1,406 | 1,724 | 3,972 | 4,727 | ||||||||||
| OPERATING LOSS | 5,637 | 6,477 | 17,083 | 16,833 | ||||||||||
| OTHER FINANCIAL (INCOME) | (387 | ) | 28 | (640 | ) | (430 | ) | |||||||
| FINANCIAL EXPENSES | 102 | 35 | 142 | 43 | ||||||||||
| FINANCIAL INCOME, net | (285 | ) | 63 | (498 | ) | (387 | ) | |||||||
| COMPREHENSIVE LOSS | $ | 5,352 | $ | 6,540 | $ | 16,585 | $ | 16,446 | ||||||
| LOSS PER ORDINARY SHARE | U.S. dollars | |||||||||||||
| Basic and diluted | $ | 0.15 | $ | 0.24 | $ | 0.52 | $ | 0.61 | ||||||
| Number of shares | ||||||||||||||
| WEIGHTED AVERAGE ORDINARY SHARES OUTSTANDING- | ||||||||||||||
| Basic and diluted | 35,865,050 | 27,100,213 | 31,987,750 | 27,005,550 | ||||||||||