- 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
TEL AVIV, Israel, March 27, 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, announced financial results for the 3- and 12-months ended December 31, 2016, as well as a corporate update.
“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 Dror Harats, Chief Executive Officer of VBL Therapeutics. “Our GLOBE pivotal trial in rGBM completed enrollment five months ahead of schedule and we continue to expect the interim analysis to occur in mid-2017 with top line data from the full dataset becoming available in early 2018. Additionally, we intend to launch a Phase 3 pivotal study in platinum-resistant ovarian cancer during the second half of 2017, and are also exploring the launch of an exploratory clinical study of VB-111 in combination with a checkpoint inhibitor.”
“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, Israel, which will house VBL’s local biological drugs manufacturing facility.
- 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 December 31, 2016, the Company had cash, cash equivalents and short-term bank deposits of $45.3 million and working capital of $41.8 million. The Company expects that its cash and cash equivalents and short-term bank deposits will enable it to fund operating expenses and capital expenditure requirements into 2019. It is expected to be sufficient to enable completion of the on-going GLOBE Phase 3 clinical trial of VB-111 in rGBM, to support the Phase 3 clinical trial for VB-111 in ovarian cancer and an exploratory clinical study of VB-111 in combination with a checkpoint inhibitor as well as to support the investment in the new Modiin facility.
• R&D Expenses: Research and development expenses for the year ended December 31, 2016 were $12.4 million, compared to $11.2 million for the year ended December 31, 2015. The increase in research and development expenses in 2016 was mainly due to increased expenses for the VB-111 subcontractors and consultants in 2016 of $2.4 million as the Phase 3 pivotal trial of VB-111 in rGBM gained momentum with the completion of patient recruitment and trial progression.
• G&A Expenses: General and administrative expenses for the year ended December 31, 2016 was $3.8 million, compared to $3.7 million for the year ended December 31, 2015.
• Net Loss: The Company reported a net loss for the year ended December 31, 2016 of $16.0 million, or ($0.64) per share, compared to a net loss of $14.9 million, or ($0.73) per share in the year ended December 31, 2015.
Conference Call, Monday, March 27, 2017 @ 8:30am Eastern Time
|Replays, available through April 10, 2017:|
Investor KOL Breakfast and Live Webcast, Thursday April 6, 2016 @ 8am Eastern Time
VBL will be hosting a Key Opinion Leader breakfast on new targets and immunotherapeutic approaches to oncology, on April 6, 2017 in New York City. The meeting will feature a presentation by key opinion leader Ramy Ibrahim, MD (Parker Institute), who will discuss the current treatment landscape and unmet medical need for new targets and therapeutic approaches in oncology. VBL Therapeutics' management team will provide an overview of the Company's programs in oncology.
This event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals only. Please RSVP in advance if you plan to attend, as space is limited. To reserve a spot, please contact LifeSci Advisors, LLC at Mac@LifeSciAdvisors.com. A live and archived webcast of the event, with slides, will be available at http://lifesci.rampard.com/20170406/reg.jsp and on the Investors section of the Company’s website at http://www.vblrx.com.
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 >200 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, 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 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.|
|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:|
INVESTOR CONTACT: Michael Rice LifeSci Advisors, LLC (646) 597-6979
Source: VBL Therapeutics