VBL Therapeutics Announces Fourth Quarter and Year End 2016 Financial Results
- Interim analysis in the GLOBE pivotal study is expected in mid-2017, with top-line data expected in early 2018
- Phase 3 Study of VB-111 in Ovarian Cancer Currently Expected to Begin Enrollment in the Second Half of 2017
“By advancing its development in multiple tumor types, VBL continues to execute on our strategy of demonstrating the clinical utility of VB-111, a unique viral cancer therapy with a dual mechanism of action: vascular disruption and induction of a tumor directed local immune response. VB-111 has shown evidence of meaningful clinical benefit in recurrent glioblastoma (rGBM), platinum-resistant ovarian cancer, and radio-iodine resistant thyroid cancer,” said Professor
“VBL is well capitalized, with $45.3 million in cash and equivalents at year end 2016 which we expect will be sufficient to enable us to complete our ongoing Phase 3 clinical trial of VB-111 in rGBM, and to fund our operating expenses and capital expenditure requirements into 2019, including supporting our planned potential 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 supporting the investment in the new Modiin facility,” said Mr. Amos Ron, the Company’s CFO.
Fourth Quarter and Recent Corporate Update
• Completed enrollment in the pivotal GLOBE study investigating VB-111 in rGBM.
- Enrollment in the study, 256 patients in total, was completed ahead of schedule.
- Company reiterated its guidance for GLOBE interim analysis to occur in mid-2017, and that top-line results from the full dataset will be available in early 2018.
• Held an End-of-Phase 2 meeting with the FDA to discuss the clinical path of VB-111 in ovarian cancer.
- Reached agreement with the FDA on the clinical plan to proceed directly to a Phase 3 pivotal study in platinum-resistant patients, with overall survival as the primary endpoint.
• Announced full results from its exploratory Phase 2 study of VB-111 in patients with advanced, differentiated thyroid cancer.
- The study previously met its primary endpoint, defined as 6-month progression-free-survival (PFS-6) of 25% was met with a dose response.
- 47% of patients in the therapeutic dose cohort reached PFS-6, versus 25% in the sub-therapeutic cohort, both groups meeting the primary endpoint.
- Overall survival benefit was seen with a tail of more than 40% at 3.7 years for the therapeutic-dose cohort (mOS 684 days).
• Signed a long-term lease contract for a new manufacturing facility in Modiin,
- The new facility will also include the Company’s headquarters, discovery, research, and clinical development.
- The Company intends to operate and relocate to the new site in the second half of 2017.
• Published research discussing MOSPD2, a potential novel immune-oncology target.
- Targeting of MOSPD2 may have several therapeutic applications, including inhibition of monocyte migration in chronic inflammatory conditions inhibition of tumor cell metastases and targeting of MOSPD2 tumor cells.
- VBL’s “VB-600 series” of pipeline candidates is being developed toward these applications.
- Additional findings related to MOSPD2 will be announced in the second quarter of 2017.
Full-Year 2016 Financial Results:
• Cash Position: At
• R&D Expenses: Research and development expenses for the year ended
• G&A Expenses: General and administrative expenses for the year ended
• Net Loss: The Company reported a net loss for the year ended
|Replays, available through April 10, 2017:
Investor KOL Breakfast and Live Webcast,
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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, 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, 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.|
|STATEMENTS OF FINANCIAL POSITION|
|Cash and cash equivalents||$||11,585||$||7,090|
|Short-term bank deposits||33,669||30,056|
|Other current assets||1,320||1,446|
|TOTAL CURRENT ASSETS||46,574||38,592|
|Property and equipment, net||687||326|
|Long-term prepaid expenses||13||320|
|TOTAL NON-CURRENT ASSETS||700||646|
|Liabilities and equity|
|TOTAL CURRENT LIABILITIES||4,788||4,158|
|Severance pay obligations, net||86||73|
|Ordinary shares, NIS 0.01 par value; Authorized as of
December 31, 2016 and 2015, 70,000,000 shares; issued
and outstanding as of December 31, 2016 and 2015,
26,902,285 and 22,470,321 shares, respectively
|Other comprehensive income||40||45|
|Additional paid in capital||197,400||174,012|
|TOTAL LIABILITIES AND EQUITY||$||47,274||$||39,238|
|VASCULAR BIOGENICS LTD.|
|STATEMENTS OF COMPREHENSIVE LOSS|
|Year ended December 31|
|U.S. dollars in thousands
|RESEARCH AND DEVELOPMENT EXPENSES, net||$||12,447||$||11,198|
|GENERAL AND ADMINISTRATIVE EXPENSES||3,828||3,673|
|Loss from change in fair value of convertible loan||-||-|
|Other financial expenses||12||117|
|FINANCIAL EXPENSES (INCOME), net||(273||)||17|
|LOSS FOR THE YEAR||16,002||14,888|
|OTHER COMPREHENSIVE (INCOME) LOSS—|
|Items that will not be reclassified to profit or loss—|
|Re-measurements of post-employment benefit obligation||5||(6||)|
|LOSS PER ORDINARY SHARE|
|Basic and diluted||$||0.64||$||0.73|
|Number of shares
|WEIGHTED AVERAGE ORDINARY SHARES OUTSTANDING—|
|Basic and diluted||24,970,585||20,309,596|
|VASCULAR BIOGENICS LTD.|
|STATEMENTS OF CASH FLOWS|
|Year ended December 31|
|U.S. dollars in thousands|
|CASH FLOWS FROM OPERATING ACTIVITIES:|
|Loss for the year||$||(16,002||)||$||(14,888||)||$||(17,407||)|
|Adjustments required to reflect net cash used in operating activities (see Appendix A)||2,340||1,641||3,689|
|Net cash used in operating activities||(13,412||)||(13,203||)||(13,703||)|
|CASH FLOWS FROM INVESTING ACTIVITIES:|
|Purchase of property and equipment||(491||)||(90||)||(57||)|
|Investment in short-term deposits||(3,600||)||(30,000||)||-|
|Maturity of short-term deposits||-||-||1,494|
|Net cash generated from (used in) investing activities||(4,091||)||(30,090||)||1,437|
|CASH FLOWS FROM FINANCING ACTIVITIES:|
|Exercise of employees stock options||121||95||267|
|Issuance of preferred E shares||—||-||4,938|
|Issuance of ordinary shares and warrants, net||21,859||13,651||34,879|
|Net cash generated from financing activities||21,980||13,746||40,084|
|NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS||4,477||(29,547||)||27,818|
|CASH AND CASH EQUIVALENTS AT BEGINNING OF THE YEAR||7,090||36,783||9,377|
|EXCHANGE GAINS (LOSSES) ON CASH AND CASH EQUIVALENTS||18||(146||)||(412||)|
|CASH AND CASH EQUIVALENTS AT END OF THE YEAR||$||11,585||$||7,090||$||36,783|
|Adjustments required to reflect net cash used in operating activities:|
|Loss from change in fair value of convertible loan||-||-||2,342|
|Exchange losses (gains) on cash and cash equivalents||(18||)||146||412|
|Net changes in severance pay obligations||8||(27||)||(10||)|
|Share based payments||1,420||1,041||2,617|
|Changes in working capital:|
|Decrease (increase) in other current assets||126||(485||)||(454||)|
|Decrease(increase) in long term prepaid expenses||307||(284||)||(23||)|
|Increase (decrease) accounts payable:|
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