Conference Call and Webcast at 8:30am Eastern Time
TEL AVIV, Israel, March 15, 2018 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq:VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, today announced financial results for the quarter and year-ended December 31, 2017 and provided a corporate update.
"VBL has more than $50 million in cash, which will enable us to continue the development of VB-111 and our promising pipeline through 2020," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "We intend to continue the ongoing OVAL trial, our Phase 3 potential registration trial in platinum-resistant ovarian cancer, in collaboration with the GOG Foundation. We intend to add an interim analysis for evidence of efficacy signal in our OVAL trial, sooner than in our original plan. We expect that the interim readout may be available during the first half of 2019."
"Beyond VB-111, we have a strong pipeline, including our exciting MOSPD2 program for oncology and inflammatory indications. We intend to present new data from this program in oncology as a late-breaking news at the forthcoming American Academy of Cancer Research (AACR) meeting in April 2018."
Fourth Quarter and Recent Corporate Highlights:
- Reported top-line results from its pivotal Phase 3 GLOBE study in patients with rGBM which was designed to evaluate VB-111 in combination with bevacizumab (Avastin®), compared with bevacizumab alone.
- The study did not meet its pre-specified primary endpoint of overall survival (OS) or secondary endpoint progression-free-survival (PFS).
- Announced the initiation of the Phase 3 potential registration trial, OVAL, studying VB-111 in platinum-resistant ovarian cancer.
- The OVAL study has been designed to enroll up to 350 adult patients at approximately 70 clinical sites in the U.S. and Israel. Patients are being randomized 1:1 to VB-111 in combination with chemotherapy, or chemotherapy alone. The primary endpoint is overall survival.
- The study is being conducted in collaboration with the Gynecologic Oncology Group (GOG) Foundation, Inc., a leading organization for research excellence in the field of gynecology malignancies.
- The European Medicines Agency (EMA) designated VB-111 as an “orphan medicinal product” for the treatment of ovarian cancer in October 2017.
- Signed an exclusive license agreement with NanoCarrier Co., Ltd. (TSE Mothers:4571) for the development, commercialization and supply of VB-111 in Japan.
- In February 2018, VBL received a milestone payment in relation to this agreement.
- Opened new gene therapy manufacturing plant in Modiin, Israel.
- The Modiin facility is the first commercial-scale gene therapy manufacturing facility in Israel and currently one of the largest gene-therapy designated ones in the world (20,000 sq. ft.).
- The facility was constructed with the support of the Israel Innovation Authority of the Ministry of Economy.
- Appointed David Hastings and Susan Kelley, M.D. to its Board of Directors.
- In November 2017, raised $18.75 million in gross proceeds, before deducting the underwriting discounts and commissions and other estimated expenses, in a public offering of common stock.
Year Ended December 31, 2017 Financial Results
- Revenues: In 2017 we recognized revenues of $13.8 million, generated from the licensing and development agreement with NanoCarrier.
- Cash Position: At December 31, 2017, we had cash, cash equivalents and short-term bank deposits of $54.7 million and working capital of $50.9 million. We expect that our cash and cash equivalents and short-term bank deposits will enable us to fund our operating expenses and capital expenditure requirements through 2020.
- R&D Expenses: Research and development expenses for the year ended December 31, 2017 were approximately $17.8 million, compared to approximately $12.4 million in the year ended December 31, 2016.
- G&A Expenses: General and administrative expenses for the year ended December 31, 2017 were approximately $5.8 million, compared to approximately $3.8 million in the year ended December 31, 2016.
- Comprehensive Loss: The Company reported a comprehensive loss for the year ended December 31, 2017 of $10.2 million, or ($0.37) per share, compared to a net loss of $16.0 million, or ($0.64) per share in the year ended December 31, 2016.
Conference Call
| Thursday, March 15th @ 8:30am Eastern Time | |
| Domestic: | 877-222-6394 |
| International: | 703-925-2702 |
| Conference ID: | 7392936 |
| Webcast: | https://edge.media-server.com/m6/p/y3srj89d |
| Replays, Available through March 29th: | |
| Domestic: | 855-859-2056 |
| International: | 404-537-3406 |
| Conference ID: | 7392936 |
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 projected cash resources and cash runway, the clinical development of ofranergene obadenovec (VB-111) and our other pipeline candidates, including our expectations for their therapeutic potential in the conditions in which they are being or may in the future be evaluated. 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 our product candidates that we are developing may not demonstrate success in clinical trials. 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. 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, LLC
(646) 597-6979
MEDIA CONTACT:
Matt Middleman, M.D.
LifeSci Public Relations
matt@lifescipublicrelations.com
(646) 627-8384
| VASCULAR BIOGENICS LTD. | ||||||||
| STATEMENTS OF FINANCIAL POSITION | ||||||||
| December 31 | ||||||||
| 2017 | 2016 | |||||||
| U.S. dollars in thousands | ||||||||
| Assets | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 6,694 | $ | 11,585 | ||||
| Short-term bank deposits | 48,035 | 33,669 | ||||||
| Trade receivables | 2,000 | — | ||||||
| Other current assets | 1,729 | 1,320 | ||||||
| TOTAL CURRENT ASSETS | 58,458 | 46,574 | ||||||
| NON-CURRENT ASSETS: | ||||||||
| Property and equipment, net | 7,128 | 687 | ||||||
| Long-term prepaid expenses | 103 | 13 | ||||||
| TOTAL NON-CURRENT ASSETS | 7,231 | 700 | ||||||
| TOTAL ASSETS | $ | 65,689 | $ | 47,274 | ||||
| Liabilities and equity | ||||||||
| CURRENT LIABILITIES— | ||||||||
| Accounts payable: | ||||||||
| Trade | $ | 3,058 | $ | 2,522 | ||||
| Other | 3,465 | 2,266 | ||||||
| Deferred revenue | 1,046 | — | ||||||
| TOTAL CURRENT LIABILITIES | 7,569 | 4,788 | ||||||
| NON-CURRENT LIABILITIES— | ||||||||
| Severance pay obligations, net | 128 | 86 | ||||||
| Deferred revenue | 2,092 | — | ||||||
| TOTAL NON-CURRENT LIABILITIES | 2,220 | 86 | ||||||
| TOTAL LIABILITIES | 9,789 | 4,874 | ||||||
| COMMITMENTS | ||||||||
| EQUITY: | ||||||||
| Ordinary shares, NIS 0.01 par value; Authorized as of December 31, 2017 and 2016, 70,000,000 shares; issued and outstanding as of December 31, 2017 and 2016, 29,879,323 and 26,902,285 shares, respectively | 57 | 50 | ||||||
| Accumulated other comprehensive income | 16 | 40 | ||||||
| Additional paid in capital | 221,055 | 197,400 | ||||||
| Warrants | 2,960 | 2,960 | ||||||
| Accumulated deficit | (168,188 | ) | (158,050 | ) | ||||
| TOTAL EQUITY | 55,900 | 42,400 | ||||||
| TOTAL LIABILITIES AND EQUITY | $ | 65,689 | $ | 47,274 | ||||
| VASCULAR BIOGENICS LTD. | ||||||||||||
| STATEMENTS OF COMPREHENSIVE LOSS | ||||||||||||
| Year ended December 31 | ||||||||||||
| 2017 | 2016 | 2015 | ||||||||||
| U.S. dollars in thousands | ||||||||||||
| REVENUES | 13,864 | — | — | |||||||||
| COST OF REVENUES | (340 | ) | — | — | ||||||||
| GROSS PROFIT | 13,524 | — | — | |||||||||
| RESEARCH AND DEVELOPMENT EXPENSES, net | $ | 17,770 | $ | 12,447 | $ | 11,198 | ||||||
| MARKETING EXPENSES | 562 | — | — | |||||||||
| GENERAL AND ADMINISTRATIVE EXPENSES | 5,847 | 3,828 | 3,673 | |||||||||
| OPERATING LOSS | 10,655 | 16,275 | 14,871 | |||||||||
| FINANCIAL INCOME | (544 | ) | (285 | ) | (100 | ) | ||||||
| FINANCIAL EXPENSES | 27 | 12 | 117 | |||||||||
| FINANCIAL EXPENSES (INCOME), net | (517 | ) | (273 | ) | 17 | |||||||
| LOSS FOR THE YEAR | 10,138 | 16,002 | 14,888 | |||||||||
| OTHER COMPREHENSIVE LOSS (INCOME)— | ||||||||||||
| Items that will not be reclassified to profit or loss— | ||||||||||||
| Re-measurements of post-employment benefit obligation | 24 | 5 | (6 | ) | ||||||||
| COMPREHENSIVE LOSS | $ | 10,162 | $ | 16,007 | $ | 14,882 | ||||||
| U.S. dollars | ||||||||||||
| LOSS PER ORDINARY SHARE | ||||||||||||
| Basic and diluted | $ | 0.37 | $ | 0.64 | $ | 0.73 | ||||||
| Number of shares | ||||||||||||
| WEIGHTED AVERAGE ORDINARY SHARES OUTSTANDING— | ||||||||||||
| Basic and diluted | 27,398,169 | 24,970,585 | 20,309,596 | |||||||||