VBL Therapeutics Announces Third Quarter 2017 Financial Results
Conference Call and Webcast at
“We were pleased to announce last week the signing of an exclusive license agreement with
“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, 2017to conduct its third and final safety review.
○ The DSMC reviewed the GLOBE safety data, including mortality data, collected through a cutoff date in
August 2017and 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,
○ 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
Israeland 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 millionin 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
- Cash Position: At
September 30, 2017, we had cash, cash equivalents and short-term bank deposits totaling $28.2 millionand working capital of $24.4 million. In November we received an additional $15 millionin 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, 2017were approximately $4.8 million, compared to approximately $2.2 millionin the same period of 2016.
- G&A Expenses: General and administrative expenses for the quarter ended
September 30, 2017were approximately $1.7 million, compared to approximately $1.1 millionin the same period of 2016.
- Comprehensive Loss: The Company reported a comprehensive loss for the quarter ended
September 30, 2017of $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
- R&D Expenses: Research and development expenses (net) were
$12.1 millionfor the nine-month period of 2017, compared to $8.5 millionfor 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 millionin 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 ($0.46)per share in the nine months of 2016.
Replays, Available through
Forward Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. These forward-looking statements include, but are not limited to, statements regarding the clinical development of ofranergene obadenovec (VB-111) and its therapeutic potential, ongoing and planned clinical trials and clinical results, including the timing thereof, our other pipeline candidates, including the clinical development and therapeutic potential of our VB-600 series of pipeline candidates and Lecinoxoids in NASH, our new Modiin facility and our cash position and financial outlook. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and the risk that historical clinical trial results may not be predictive of future trial results. In particular, results from our pivotal Phase 3 clinical trial of ofranergene obadenovec (VB-111) in rGBM may not support approval of ofranergene obadenovec for marketing in
|VASCULAR BIOGENICS LTD.|
|CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION|
|September 30,||December 31,|
|U.S. dollars in thousands|
|Cash and cash equivalents||$||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|
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