TEL AVIV, Israel, May 12, 2015 (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, today reported 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 Monday, June 1."
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 FDA partial clinical hold on VB-111: VBL announced that the FDA has 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, 2015 were $34.4 million, compared to $36.8 million at year end 2014.
- R&D Expenses: Research and development expenses were $2.0 million in the first quarter of 2015, compared to $2.3 million in 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 million in the first quarter of 2015, compared to $0.6 million in 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 million for the first quarter of 2015, compared to net loss of $5.1 million for 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 Aviv on Wednesday, May 13, 2015 at 2:20 p.m. IST (7:20 a.m. ET).
- UBS Global Healthcare Conference in New York on May 18-20, 2015. Company management will participate in 1x1s.
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2015 American Society of Clinical Oncology (ASCO) Annual Meeting, May 29-June 1, 2015 in 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, 2015 at 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 Convention in Philadelphia on Monday, June 15 – Thursday, June 18, 2015.
- JMP Securities Healthcare Conference in New York on Tuesday, June 23, 2015 at 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.
Conference Call:
VBL Therapeutics will be hosting a conference call and webcast today, May 12, 2015, at 8:30 a.m. U.S. Eastern Time. The conference call may be accessed by dialing 877 280 2343 for domestic participants and 972 3763 0146 for international participants (reference conference ID 5889296). A live webcast of the call will be available online from the investor relations section of the company website at ir.vblrx.com. A webcast replay of the conference call will be available on the VBL website beginning approximately two hours after the event, and will be available for 30 days.
About VBL:
Vascular Biogenics Ltd., operating as VBL Therapeutics, is a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of first-in-class treatments for cancer. VBL has also developed a proprietary platform of small molecules, Lecinoxoids, for the treatment of chronic immune-related indications. The Company's lead oncology product candidate, VB-111, is a gene-based biologic that is initially being developed for recurrent glioblastoma, or rGBM, an aggressive form of brain cancer. VB-111 has received orphan drug designation in both the United States and Europe and was granted Fast Track designation by the FDA for prolongation of survival in patients with glioblastoma that has recurred following treatment with standard chemotherapy and radiation. VBL Therapeutics expects to begin the pivotal Phase 3 trial for VB-111 in rGBM in mid-2015, under a special protocol assessment agreement granted by the FDA.
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 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. | |||
| CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION | |||
| (UNAUDITED) | |||
| March, 31 | December 31, | ||
| 2015 | 2014 | 2014 | |
| (Unaudited) | (Audited) | ||
| U.S. dollars in thousands | |||
| Assets | |||
| CURRENT ASSETS: | |||
| 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 |
| NON-CURRENT ASSETS: | |||
| Property and equipment, net | 348 | 422 | 358 |
| Long-term prepaid expenses | 39 | 12 | 36 |
| TOTAL NON-CURRENT ASSETS | 387 | 434 | 394 |
| TOTAL ASSETS | 35,393 | 9,636 | 38,138 |
| Liabilities and capital deficiency | |||
| CURRENT LIABILITIES - | |||
| Accounts payable: | |||
| Trade | 1,638 | 894 | 695 |
| Other | 1,288 | 3,989 | 2,235 |
| TOTAL CURRENT LIABILITIES | 2,926 | 4,883 | 2,930 |
| NON-CURRENT LIABILITIES: | |||
| Convertible loan | — | 33,137 | — |
| Severance pay obligations, net | 103 | 126 | 106 |
| TOTAL NON-CURRENT LIABILITIES | 103 | 33,263 | 106 |
| TOTAL LIABILITIES | 3,029 | 38,146 | 3,036 |
| Equity (CAPITAL DEFICIENCY): | |||
| Ordinary Shares | 32 | 1 | 32 |
| Preferred Shares | — | 7 | — |
| Other comprehensive income | 39 | 29 | 39 |
| Additional paid in capital | 162,430 | 86,261 | 162,191 |
| Accumulated deficit | (130,137) | (114,808) | (127,160) |
| 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 | |||
| (UNAUDITED) | |||
| Three months ended March 31, | Year ended December 31, | ||
| 2015 | 2014 | 2014 | |
| U.S dollars in thousands | |||
| (Unaudited) | (Audited) | ||
| RESEARCH AND DEVELOPMENT EXPENSES, net | $2,030 | $2,347 | $10,974 |
| GENERAL AND ADMINISTRATIVE EXPENSES | 799 | 576 | 3,804 |
| OPERATING LOSS | 2,829 | 2,923 | 14,778 |
| FINANCIAL INCOME | (15) | (4) | (15) |
| 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) |
| Comprehensive loss | $2,977 | $5,055 | $17,397 |
| U.S. dollars | |||
| 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 |