VBL Therapeutics Announces Full-Year 2015 Financial Results and Provides Business Update
“2015 was marked by major accomplishments in the clinic as we advanced VB-111, our first-in-class gene-therapy based agent for solid tumor indications,” said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. “The positive data we reported in recurrent glioblastoma (rGBM), thyroid and ovarian cancers supports our conviction that VB-111 has the potential to become an important treatment option for various solid tumors cancer patients.”
“Our GLOBE™ study in rGBM, which we initiated in
“We look forward to additional data readouts and presentations on VB-111 in 2016. We expect to release updated results from the ovarian cancer trial, which will include data from tumor biopsies as well as survival data. In thyroid cancer, we will continue to observe the enrolled patients in the Phase 2 trial and expect to provide a full report by the end of the year.”
“VBL is well capitalized, with
2015 Clinical and Corporate Highlights:
- Initiated Pivotal Phase 3 GLOBE™ Study of VB-111 in Recurrent Glioblastoma: The GLOBE™ Study is a Phase 3 trial of VB-111 in rGBM, that is proceeding under a special protocol assessment (SPA) granted by the U.S. Food and Drug Administration (
FDA). The trial is expected to enroll 252 patients with rGBM and will recruit patients from about 50 sites in the United States, Canada and Israel. The primary efficacy endpoint is overall survival. The trial is recruiting according to plan and an interim analysis is expected to occur in the first half of 2017, based on enrollment and VB-111 activity.
- Reported full Phase 2 Data from Clinical Trial of VB-111 in rGBM at the European Cancer Conference (ECC 2015): Trial met primary endpoint, showing statistically significant overall survival benefit. Patients treated with VB-111 in combination with Avastin™ upon disease progression (continuous exposure cohort) had a median overall survival (mOS) of 15 months, compared to mOS of 8 months in patients treated with VB-111 followed by Avastin™ alone (p=0.048). The Company also reported an overall response rate (ORR) data of 29%, with 2 complete responders in the continuous exposure cohort, compared to 9% with no complete responders in the limited exposure cohort.
- Presented data on VB-111 at the 20th Annual Scientific Meeting and Education Day of the
Society for Neuro-Oncology(SNO): The results showed significant improvement of 12-month overall survival (OS), with 57% on VB-111 compared to data pooled from four different Avastin™ studies in rGBM reporting 28%, with a p-value of 0.007. Full formal comparison of VB-111 Phase 2 data to an independent academic meta-analysis of Avastin historical control data, will be presented in the 2nd quarter of 2016.
- Announced positive results from the multi-cohort Phase 2 trial of VB-111 in advanced radioiodine-refractory differentiated thyroid cancer (RAIR-DTC): The pre-specified primary trial endpoint of 6-month Progression Free Survival (PFS) for at least 25% of enrolled patients was met, showing a dose response for VB-111.
- Presented positive interim results from VB-111 Phase 1/2 study in platinum-resistant ovarian cancer: At the 2015 American Society of Clinical Oncology (
ASCO) annual meeting in June, VBL announced promising interim results from the Phase 1/2, investigator-initiated trial of multiple-dose VB-111 in patients with recurrent, platinum-resistant ovarian cancer. The data demonstrated evidence of clinical benefit in patients who received VB-111 in conjunction with weekly paclitaxel, with 60% of high-dose patients meeting the GCIG response criteria based on a reduction of at least 50% in the CA-125 tumor-marker levels.
- Presented data on proprietary gene therapy Vascular Targeting System (VTS)™: At the
Drug Discovery and World Therapy Congress(DDTWC), VBL presented data on VTS, the Company’s proprietary gene therapy technology which enables targeted and specific expression of a gene of choice in angiogenic blood vessels through unique "super enhancer" DNA regulatory sequences.
- Strengthened intellectual property: Granted US Patent No. 9,200,056, entitled "A Fas-Chimera Adenovirus Vector" covering VB-111. This composition of matter patent provides intellectual property protection for VB-111 in the US until
October 2033, before any patent term extension.
- Completed an underwritten offering, raising $15 million in gross proceeds: In
November 2015, the Company closed an underwritten offering of 2.5 million ordinary shares together with accompanying warrants to purchase an aggregate of 1.25 million shares. The aggregate net proceeds from this offering were approximately $14 million, after deducting underwriting discounts and commissions.
Full-Year 2015 Financial Results:
- Cash Position: Cash, cash equivalents and short-term bank deposits as of
December 31, 2015were $37.1 million, compared to $36.8 millionat year-end 2014. The Company expects that the cash position is sufficient to complete the on-going Phase 3 clinical trial of VB-111 in rGBM, the Phase 2 clinical trial of VB-111 in thyroid cancer, and the Phase 2a clinical trial for VB-111 in ovarian cancer.
- R&D Expenses: Research and development expenses were
$11.2 millionfor the year ended December 31, 2015, compared to $11.0 millionin the year ended December 31, 2014. The bulk of the R&D Expenses was for the VB-111 subcontractors and consultants in 2015 as the Phase 3 pivotal trial of VB-111 in rGBM commenced in August 2015.
- G&A Expenses: General and administrative expenses were
$3.7 millionfor the year ended December 31, 2015, compared to $3.8 millionin the year ended December 31, 2014.
- Net Loss: Net loss was
$14.9 million, or $0.73per share for the year ended December 31, 2015, compared to net loss of $17.4 million, or $3.09per share in the same period of 2014.
Avastin™ is a registered trademark of Genentech.
Replays, available through
Forward Looking Statements:
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to”, “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. These forward-looking statements include, but are not limited to, statements regarding the clinical development of VB-111 and its therapeutic potential and clinical results, including statements related to the GLOBE study and the timing of our BLA, our intellectual property protection from our US Patent No. 9,200,056, and our cash position and funding requirements. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and the risk that historical clinical trial results may not be predictive of future trial results. In particular, results from our pivotal Phase 3 clinical trial of VB-111 in rGBM may not support approval of VB-111 for marketing in
|VASCULAR BIOGENICS LTD.|
|STATEMENTS OF FINANCIAL POSITION|
|A s s e t s|
|Cash and cash equivalents||$||7,090||$||36,783|
|Short-term bank deposits||30,056||-|
|Other current assets||1,446||961|
|TOTAL CURRENT ASSETS||38,592||37,744|
|Property and equipment, net||326||358|
|Long-term prepaid expenses||320||36|
|TOTAL NON-CURRENT ASSETS||646||394|
|Liabilities and equity|
|CURRENT LIABILITIES -|
|TOTAL CURRENT LIABILITIES||4,158||2,930|
|NON-CURRENT LIABILITIES -|
|Severance pay obligations, net||73||106|
|Ordinary shares, NIS 0.01 par value; Authorized as of
December 31, 2015 and 2014, 70,000,000 and 49,200,000
shares, respectively; issued and outstanding as of
December 31, 2015 and 2014, 22,470,321 and 19,898,674
|Other comprehensive income||45||39|
|Additional paid in capital||174,012||162,191|
|TOTAL LIABILITIES AND EQUITY||$||39,238||$||38,138|
|VASCULAR BIOGENICS LTD.|
|STATEMENTS OF COMPREHENSIVE LOSS|
|U.S. dollars in thousands
|RESEARCH AND DEVELOPMENT EXPENSES, net||$||11,198||$||10,974|
|GENERAL AND ADMINISTRATIVE EXPENSES||3,673||3,804|
|Loss from change in fair value of convertible loan||-||2,342|
|Other financial expenses||117||302|
|FINANCIAL EXPENSES (INCOME), net||17||2,629|
|LOSS FOR THE YEAR||14,888||17,407|
|OTHER COMPREHENSIVE INCOME -|
|items that will not be reclassified to profit or loss -|
|re-measurements of post-employment benefit obligation||(6||)||(10||)|
|LOSS PER ORDINARY SHARE||U.S. dollars
|basic and diluted||$||0.73||$||3.09|
|WEIGHTED AVERAGE ORDINARY SHARES OUTSTANDING -|
|basic and diluted||20,309,596||5,627,324|
Michael Rice LifeSci Advisors, LLC(646) 597-6979