Conference Call and Webcast at 8:30am Eastern Time Today
TEL AVIV, Israel, Nov. 14, 2017 (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 three and nine months ended September 30, 2017 and provided a corporate update.
“We were pleased to announce last week the signing of an exclusive license agreement with NanoCarrier Co., Ltd. (NanoCarrier) for the development, commercialization and supply of VB-111 in Japan. The license agreement with NanoCarrier provided for an upfront payment of $15 million on November 7, 2017, which strengthens our cash position with non-dilutive money and provides external validation of the Company and VB-111. Our Phase 3 GLOBE Trial investigating VB-111 in recurrent glioblastoma multiforme (rGBM) is moving according to plan, and the Data Safety Monitoring Committee, in their last and final safety review, recommended that the study continue to completion,” said Prof. Dror Harats, Chief Executive Officer of VBL Therapeutics. “We currently expect top line results in the first quarter of 2018. As we advance towards our planned Biologics License Application (BLA) filing for VB-111, we continue to make preparations for launch and commercialization. We were pleased to open our state of the art gene therapy manufacturing facility in Modiin, Israel, which is designed to produce commercial quantities of the drug.”
“Beyond rGBM, we remain on-track to initiate a Phase 3 study of VB-111 in ovarian cancer by year-end 2017,” continued Harats. “We are also planning an exploratory clinical study in combination with a checkpoint inhibitor in lung cancer in the first quarter of 2018.”
Third Quarter and Recent Corporate Highlights:
- The independent Data Safety Monitoring Committee (DSMC) overseeing the ongoing Phase 3 GLOBE Study investigating ofranergene obadenovec (VB-111) in recurrent glioblastoma (rGBM) met on September 28, 2017 to conduct its third and final safety review.
○ The DSMC reviewed the GLOBE safety data, including mortality data, collected through a cutoff date in August 2017 and unanimously recommended that the study continue as planned, to completion.
○ No additional interim analyses are planned, and top-line results from the study are expected to be available in the first quarter of 2018.
- VBL opened its new company headquarters and gene therapy manufacturing plant in Modiin, Israel.
○ This plant will be the commercial facility for production of the Company’s lead product candidate VB-111, if approved.
○ 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.).
- Signed an exclusive license agreement with NanoCarrier Co., Ltd. for the development, commercialization, and supply of VB-111 in Japan.
○ VBL received an up-front payment of $15 million, and is entitled to receive greater than $100 million in development and commercial milestone payments, as well as tiered royalties in the high-teens on net sales.
- VBL’s cash position is strengthened to fund operations through 2019.
- The European Medicines Agency (EMA) designated VB-111 as an “orphan medicinal product” for the treatment of ovarian cancer, adding to the orphan status already granted for glioblastoma in US and Europe.
Third Quarter Ended September 30, 2017 Financial Results:
- Cash Position: At September 30, 2017, we had cash, cash equivalents and short-term bank deposits totaling $28.2 million and working capital of $24.4 million. In November we received an additional $15 million in cash as an upfront payment from NanoCarrier Co., Ltd., under the exclusive license agreement to develop, commercialize and supply VB-111 in Japan. We expect that our cash, cash equivalents and short-term bank deposits will enable us to fund our operating expenses and capital expenditure requirements through 2019, and expect such cash, cash equivalents and short-term bank deposits to be sufficient to enable us to complete our on-going Phase 3 clinical trial of VB-111 in rGBM, to prepare for the commercialization of VB-111 for rGBM in the US, to support our planned registration trial in ovarian cancer and an exploratory clinical study of VB-111 in combination with a checkpoint inhibitor in lung cancer, as well as to support the investment in the new Modiin facility.
- R&D Expenses: Research and development expenses for the quarter ended September 30, 2017 were approximately $4.8 million, compared to approximately $2.2 million in the same period of 2016.
- G&A Expenses: General and administrative expenses for the quarter ended September 30, 2017 were approximately $1.7 million, compared to approximately $1.1 million in the same period of 2016.
- Comprehensive Loss: The Company reported a comprehensive loss for the quarter ended September 30, 2017 of $6.5 million, or ($0.24) per share, compared to a net loss of $3.2 million, or ($0.12) per share in the quarter ended September 30, 2016.
Nine Months Ended September 30, 2017 Financial Results:
- R&D Expenses: Research and development expenses (net) were $12.1 million for the nine-month period of 2017, compared to $8.5 million for the nine-month period of 2016.
- G&A Expenses: General and administrative expenses for the nine-month period of 2017 were $4.7 million, compared to $3.0 million in the same period of 2016.
- Comprehensive Loss: Comprehensive loss for the nine months of 2017 was $16.4 million, or ($0.61) per share, compared to a net loss of $11.2 million, or ($0.46) per share in the nine months of 2016.
Tuesday, November 14 @ 8:30am Eastern Time
Replays, Available through November 28th:
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 we have observed its 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 pivotal trial for recurrent Glioblastoma, conducted under an FDA Special Protocol Assessment (SPA).
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 the clinical development of ofranergene obadenovec (VB-111) and its therapeutic potential, ongoing and planned clinical trials and clinical results, including the timing thereof, our other pipeline candidates, including the clinical development and therapeutic potential of our VB-600 series of pipeline candidates and Lecinoxoids in NASH, our new Modiin facility and our cash position and financial outlook. 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, and the risk that historical clinical trial results may not be predictive of future trial results. In particular, results from our pivotal Phase 3 clinical trial of ofranergene obadenovec (VB-111) in rGBM may not support approval of ofranergene obadenovec for marketing in the United States, notwithstanding the positive results seen in prior clinical experience. 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. 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.
|VASCULAR BIOGENICS LTD.|
|CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION|
|September 30,||December 31,|
|U.S. dollars in thousands|
|Cash and cash equivalents||$||11,667||$||11,585|
|Short-term bank deposits||16,497||33,669|
|Other current assets||1,201||1,320|
|TOTAL CURRENT ASSETS||29,365||46,574|
|Property and equipment, net||5,644||687|
|Long-term prepaid expenses||134||13|
|TOTAL NON-CURRENT ASSETS||5,778||700|
|Liabilities and equity|
|Accounts payable and accrued expenses:|
|TOTAL CURRENT LIABILITIES||5,007||4,788|
|Severance pay obligations, net||93||86|
|Accumulated other comprehensive income||40||40|
|Additional paid in capital||201,489||197,400|
|TOTAL LIABILITIES AND EQUITY||$||35,143||$||47,274|
|VASCULAR BIOGENICS LTD.|
|CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE LOSS|
|Three Months Ended|
|Nine Months Ended|
|U.S. dollars in thousands|
|RESEARCH AND DEVELOPMENT EXPENSES, net||$||4,753||$||2,235||$||12,106||$||8,468|
|GENERAL AND ADMINISTRATIVE EXPENSES||1,724||1,068||4,727||2,991|
|OTHER FINANCIAL (INCOME) EXPENSES||28||(112||)||(430||)||(271||)|
|FINANCIAL (INCOME) EXPENSES, net||63||(109||)||(387||)||(262||)|
|LOSS PER ORDINARY SHARE||U.S. dollars|
|Basic and diluted||$||0.24||$||0.12||$||0.61||$||0.46|
|Number of shares|
|WEIGHTED AVERAGE ORDINARY SHARES OUTSTANDING—|
|Basic and diluted||27,100,213||26,875,818||27,005,550||24,323,508|
LifeSci Advisors, LLC
LifeSci Public Relations
Source: VBL Therapeutics