VBL Therapeutics Announces First Quarter 2015 Financial Results
"During the first quarter of 2015, VBL continued to build on momentum as we look to build and advance our novel oncology franchise. In March, we announced updated topline results from our ongoing Phase 2 study of VB-111 in recurrent glioblastoma (rGBM), which demonstrated a statistically significant improvement in overall survival (p=0.05) in patients treated with VB-111 plus bevacizumab upon disease progression," said Dror Harats, M.D., Chief Executive Officer at VBL Therapeutics. "Coupled with the clinical activity observed in other recurrent oncology indications, continued evidence of VB-111's efficacy in rGBM reinforces our belief in the compound's unique mechanism of action. We look forward to providing updated interim rGBM data and top-line data from our Phase 1 trial of VB-111 in recurrent platinum-resistant Müllerian cancer in conjunction with the ASCO Annual Meeting next month, and to hosting our investor event there on
First Quarter and Recent Business Highlights:
- Announced statistically significant interim results from VB-111 Phase 1/2 Study: In March, VBL announced positive interim results from its ongoing Phase 2 trial of VB-111 in patients with recurrent glioblastoma (rGBM). A statistically significant improvement in overall survival (p=0.05) was demonstrated in patients with rGBM who received VB-111 as a standalone drug and who, upon further progression, were treated with VB-111 in combination with bevacizumab (Avastin®) compared to patients treated with bevacizumab alone upon further progression.
Announced removal of
FDApartial clinical hold on VB-111: VBL announced that the FDAhas determined that VBL may proceed with its pivotal Phase 3 trial in patients with rGBM and removed the partial clinical hold on the trial, allowing the study to proceed under a previously agreed upon special protocol assessment.
Added prominent industry veterans to Board of Directors: VBL appointed
Ron Cohen, M.D., and Philip Serlin, C.P.A. to its Board of Directors.
First Quarter 2015 Financial Results:
Cash Position: Cash, cash equivalents and short term deposits as of
March 31, 2015were $34.4 million, compared to $36.8 millionat year end 2014.
R&D Expenses: Research and development expenses were
$2.0 millionin the first quarter of 2015, compared to $2.3 millionin the comparable period in 2014. The decrease in R&D expenses was largely due to lower expenses for VB-201 subcontractors and consultants following the completion of clinical trials in 2014.
G&A Expenses: General and administrative expenses were
$0.8 millionin the first quarter of 2015, compared to $0.6 millionin the comparable period in 2014. The increase in G&A expenses was due primarily to share-based compensation expenses for options granted to two external directors of the company.
Net Loss: Net loss was
$3.0 millionfor the first quarter of 2015, compared to net loss of $5.1 millionfor the comparable period in 2014.
Upcoming Events and Presentations:
Members of VBL's management team plan to participate in the following upcoming investor conferences and medical meetings during the second quarter:
IATI Biomed 2015 Conference in
Tel Avivon Wednesday, May 13, 2015at 2:20 p.m. IST( 7:20 a.m. ET).
UBS Global Healthcare Conferencein New Yorkon May 18-20, 2015. Company management will participate in 1x1s.
American Society of Clinical Oncology( ASCO) Annual Meeting, May 29-June 1, 2015in Chicago, IL
- Poster presentation titled, "A phase I/II trial of multiple dose VB-111 and weekly paclitaxel in recurrent platinum-resistant Mullerian cancer."
VBL will host a live event with webcast on
Monday, June 1, 2015at 6:30am CT( 7:30am ET) to review the data being presented at ASCO, in addition to an updated interim analysis of its ongoing Phase 2 trial of VB-111 in rGBM.
BIO International Conventionin Philadelphiaon Monday, June 15– Thursday, June 18, 2015.
JMP Securities Healthcare Conferencein New Yorkon Tuesday, June 23, 2015at 10:30 a.m. ET.
- Live and archived webcasts of available events will be made accessible on the Company's website at www.vblrx.com.
VBL Therapeutics will be hosting a conference call and webcast today,
Forward Looking Statements:
This press release contains forward-looking statements. 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. A further list and description of these risks, uncertainties and other risks can be found in the Company's regulatory filings with the
|VASCULAR BIOGENICS LTD.|
|CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION|
|March, 31||December 31,|
|U.S. dollars in thousands|
|Cash and cash equivalents||$23,383||$7,568||$36,783|
|Short-term bank deposits||11,008||—||—|
|Other current assets||615||1,634||961|
|TOTAL CURRENT ASSETS||35,006||9,202||37,744|
|Property and equipment, net||348||422||358|
|Long-term prepaid expenses||39||12||36|
|TOTAL NON-CURRENT ASSETS||387||434||394|
|Liabilities and capital deficiency|
|CURRENT LIABILITIES -|
|TOTAL CURRENT LIABILITIES||2,926||4,883||2,930|
|Severance pay obligations, net||103||126||106|
|TOTAL NON-CURRENT LIABILITIES||103||33,263||106|
|Equity (CAPITAL DEFICIENCY):|
|Other comprehensive income||39||29||39|
|Additional paid in capital||162,430||86,261||162,191|
|TOTAL EQUITY (CAPITAL DEFICIENCY)||32,364||(28,510)||35,102|
|TOTAL LIABILITIES AND EQUITY (NET OF CAPITAL DEFICIENCY)||$35,393||$9,636||$38,138|
|VASCULAR BIOGENICS LTD.|
|CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE LOSS|
|Three months ended March 31,||Year ended December 31,|
|U.S dollars in thousands|
|RESEARCH AND DEVELOPMENT EXPENSES, net||$2,030||$2,347||$10,974|
|GENERAL AND ADMINISTRATIVE EXPENSES||799||576||3,804|
|FINANCIAL EXPENSES :|
|Loss from change in fair value of convertible loan||—||2,098||2,342|
|Other financial expenses||163||38||302|
|FINANCIAL EXPENSES, (income) net||148||2,132||2,629|
|LOSS FOR THE PERIOD||2,977||5,055||17,407|
|OTHER COMPREHENSIVE INCOME -|
|Items that will not be reclassified to profit or loss:|
|Re-measurements of post-employment benefit obligation||—||—||(10)|
|LOSS PER ORDINARY SHARE -|
|basic and diluted||$0.15||$4.59||$3.09|
|Number of Shares|
|WEIGHTED AVERAGE ORDINARY SHARE OUTSTANDING -|
|basic and diluted||19,898,674||1,102,748||5,627,324|
Hannah DeresiewiczStern Investor Relations, Inc. (212) 362-1200, firstname.lastname@example.org