TEL AVIV, Israel, Aug. 15, 2016 (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 financial results and provided a business update for the second quarter and six month period ended June 30, 2016.
“The second quarter of 2016 was marked by further progress in the clinic with our lead oncology product candidate, VB-111, which has shown evidence of benefit in multiple tumor types,” said Dror Harats, Chief Executive Officer of VBL Therapeutics. “The positive results we announced during ASCO in platinum resistant ovarian cancer and in rGBM add to the growing body of evidence suggesting that VB-111 has potent anti-tumor activity, and importantly, that it appears to be extending survival in these difficult to treat patients.”
“Our ongoing Phase 3 randomized controlled GLOBE study of VB-111 in combination with Avastin is proceeding on track,” continued Dr. Harats. “The trial, which is enrolling patients in the U.S., Canada and Israel, is covered by a Special Protocol Assessment (SPA). Our goal is to conduct an event-driven interim analysis according to the study protocol, and we think this will likely happen in the first half of 2017. We also strengthened our balance sheet during the second quarter, with the successful completion of a common stock offering, raising net proceeds of approximately $21.9 million.”
Second Quarter and Year-to-Date Clinical and Corporate Highlights:
- Presented positive clinical data on VB-111 in platinum resistant ovarian cancer during the American Society of Clinical Oncology (ASCO) Annual Meeting
- VB-111 demonstrated a statistically significant increase in overall survival in platinum resistant ovarian cancer at therapeutic vs. low dose level (810 days vs. 172 days, p=0.042)
- 60% durable response rate (as measured by reduction in CA-125 biomarker) observed with VB-111, approximately 2x the historical response with Avastin® plus chemotherapy in ovarian cancer
- Clinical data in ovarian cancer supported by immuno-therapeutic effect observed in biopsies following treatment with VB-111
- At ASCO, presented new data in recurrent glioblastoma (rGBM), comparing clinical outcomes with VB-111 with pooled data from 8 historical studies that investigated Avastin® (bevacizumab)
- Median overall survival for patients on continuous exposure of VB-111 was 59 weeks, compared with 32 weeks in historical pooled Avastin trials (p= 0.0295).
- 12-Month overall survival was 57% in patients on continuous exposure of VB-111, compared with 24% in historical pooled Avastin trials (p=0.03).
- Results for VB-201 and VB-703 for the Treatment of Non-Alcoholic Steatohepatitis (NASH) and Liver Fibrosis were published in Digestive Diseases & Sciences Magazine.
- Appointed Rachel W. Humphrey, MD, Ph.D., an expert in oncology drug development and one of the pioneers of the immune-oncology field, to head the VBL’s scientific advisory board.
- Strengthened cash position by raising approximately $21.9 million in net proceeds in a registered direct public offering.
Second Quarter Ended June 30, 2016 Financial Results:
- R&D Expenses: Research and development expenses (net) were $2.2 million for the second quarter of 2016, compared to $2.0 million in second quarter of 2015.
- G&A Expenses: General and administrative expenses for the second quarter of 2016 were $1.1 million, compared to $1.1 million in the second quarter of 2015.
- Net Loss: Net loss for the second quarter of 2016 was $3.3 million, or ($0.14) per share, compared to a net loss of $3.0 million, or ($0.15) per share in the second quarter of 2015.
- Cash Position: At June 30, 2016, cash, cash equivalents and short-term bank deposits totaled $51.6 million, inclusive of the public offering of common stock mentioned above. The Company expects that these funds will support operating expenses and capital expenditure requirements into 2019 and are expected to be sufficient to enable completion of the on-going Phase 3 registration clinical trial of VB-111 in rGBM, the Phase 2 clinical trial of VB-111 in thyroid cancer and the potential registration clinical trial for VB-111 in ovarian cancer.
Six Months Ended June 30, 2016 Financial Results:
- R&D Expenses: Research and development expenses (net) were $6.2 million for the six month period of 2016, compared to $4.0 million in same period of 2015.
- G&A Expenses: General and administrative expenses for the six month period of 2016 were $1.9 million, compared to $1.9 million in the same period of 2015.
- Net Loss: Net loss for the six months of 2016 was $8.0 million, or ($0.35) per share, compared to a net loss of $5.9 million, or ($0.30) per share in the first six months of 2015.
| Conference Call | |
| Monday, August 15th @ 8:30am Eastern Time | |
| Domestic: | 888-504-7963 |
| International: | 719-325-2376 |
| Conference ID: | 4367120 |
| Webcast: | http://edge.media-server.com/m/p/m6e587r2 |
| Replays, available through August 29th: | |
| Toll Free: | 877-870-5176 |
| International: | 858-384-5517 |
| Conference ID: | 4367120 |
About VBL
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, VB-111, is a first-in-class, targeted anti-cancer gene-therapy agent that is positioned to treat a wide range of solid tumors. VB-111 is conveniently administered as an IV infusion once every two months. It has been observed to be well-tolerated in >170 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. The mechanism of VB-111 combines blockade of tumor vasculature with an anti-tumor immune response. This mechanism retains activity regardless of baseline tumor mutations or the identity of the pro-angiogenic factors secreted by the tumor. VB-111 is currently being studied in a Phase 3 pivotal trial for Recurrent Glioblastoma (rGBM). The trial is being conducted under an FDA Special Protocol Assessment (SPA), and VB-111 has obtained fast track and Orphan designations.
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 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 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. | ||||||
| CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION | ||||||
| (UNAUDITED) | ||||||
| June 30, | December 31, | |||||
| 2016 | 2015 | |||||
| U.S. dollars in thousands | ||||||
| Assets | ||||||
| CURRENT ASSETS: | ||||||
| Cash and cash equivalents | $32,855 | $7,090 | ||||
| Short-term bank deposits | 18,724 | 30,056 | ||||
| Other current assets | 1,347 | 1,446 | ||||
| TOTAL CURRENT ASSETS | 52,926 | 38,592 | ||||
| NON-CURRENT ASSETS: | ||||||
| Property and equipment, net | 626 | 326 | ||||
| Long-term prepaid expenses | 172 | 320 | ||||
| TOTAL NON-CURRENT ASSETS | 798 | 646 | ||||
| TOTAL ASSETS | $53,724 | $39,238 | ||||
| Liabilities and equity | ||||||
| CURRENT LIABILITIES – | ||||||
| Accounts payable: | ||||||
| Trade | $1,315 | $2,050 | ||||
| Other | 2,841 | 2,108 | ||||
| TOTAL CURRENT LIABILITIES | 4,156 | 4,158 | ||||
| NON-CURRENT LIABILITIES – | ||||||
| Severance pay obligations, net | 74 | 73 | ||||
| TOTAL NON-CURRENT LIABILITIES | 74 | 73 | ||||
| TOTAL LIABILITIES | 4,230 | 4,231 | ||||
| EQUITY: | ||||||
| Ordinary Shares | 50 | 38 | ||||
| Other comprehensive income | 45 | 45 | ||||
| Additional paid in capital | 196,490 | 174,012 | ||||
| Warrants | 2,960 | 2,960 | ||||
| Accumulated deficit | (150,051) | (142,048) | ||||
| TOTAL EQUITY | 49,494 | 35,007 | ||||
| TOTAL LIABILITIES AND EQUITY | $53,724 | $39,238 | ||||
| VASCULAR BIOGENICS LTD. | |||||||||||||||||||||
| CONDENSED INTERIM STATEMENT OF COMPREHENSIVE LOSS | |||||||||||||||||||||
| (UNAUDITED) | |||||||||||||||||||||
| Three month ended | Six month ended | ||||||||||||||||||||
| June 30 | June 30 | ||||||||||||||||||||
| 2016 | 2015 | 2016 | 2015 | ||||||||||||||||||
| U.S dollars in thousands | |||||||||||||||||||||
| RESEARCH AND DEVELOPMENT | $ | 2,230 | $ | 1,989 | $ | 6,233 | $ | 4,019 | |||||||||||||
| EXPENSES, net | |||||||||||||||||||||
| GENERAL AND ADMINISTRATIVE EXPENSES | 1,060 | 1,134 | 1,923 | 1,933 | |||||||||||||||||
| OPERATING LOSS | 3,290 | 3,123 | 8,156 | 5,952 | |||||||||||||||||
| FINANCIAL INCOME | (22 | ) | (17 | ) | (159 | ) | (32 | ) | |||||||||||||
| FINANCIAL EXPENSES | 6 | (142 | ) | 6 | 21 | ||||||||||||||||
| FINANCIAL EXPENSES (INCOME), net | (16 | ) | (159 | ) | (153 | ) | (11 | ) | |||||||||||||
| COMPREHENSIVE LOSS | $ | 3,274 | $ | 2,964 | $ | 8,003 | $ | 5,941 | |||||||||||||
| LOSS PER ORDINARY SHARE, | $ | 0.14 | $ | 0.15 | $ | 0.35 | $ | 0.30 | |||||||||||||
| basic and diluted | |||||||||||||||||||||
| Number of shares | Number of shares | ||||||||||||||||||||
| WEIGHTED AVERAGE ORDINARY SHARE OUTSTANDING – | |||||||||||||||||||||
| basic and diluted | 23,602,333 | 19,914,538 | 23,033,339 | 19,906,562 | |||||||||||||||||
| VASCULAR BIOGENICS LTD. | ||||||||
| CONDENSED INTERIM CASH FLOW STATEMENTS | ||||||||
| (UNAUDITED) |
||||||||
| Six months ended June 30 |
||||||||
| 2016 | 2015 | |||||||
| U.S dollars in thousands | ||||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Loss for the period | $ | (8,003 | ) | $ | (5,941 | ) | ||
| Adjustments required to reflect net cash | ||||||||
| used in operating activities (see appendix A) | 745 | 754 | ||||||
| Interest received | 62 | 12 | ||||||
| Net cash used in operating activities | (7,196 | ) | (5,175 | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
| Purchase of property and equipment | (360 | ) | (36 | ) | ||||
| Investment in short-term deposits | – | (11,000 | ) | |||||
| Maturity of short-term deposits | 11,400 | – | ||||||
| Net cash generated from (used in) investing activities | 11,040 | (11,036 | ) | |||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Exercised of employees stock options | 47 | 29 | ||||||
| Issuance of ordinary shares and warrants, net | 21,860 | – | ||||||
| Net cash generated from financing activities | 21,907 | 29 | ||||||
| NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 25,751 | (16,182 | ) | |||||
| CASH AND CASH EQUIVALENTS AT BEGINNING OF THE YEAR | 7,090 | 36,783 | ||||||
| EXCHANGE GAINS (LOSSES) ON CASH AND CASH EQUIVALENTS | 14 | (73 | ) | |||||
| CASH AND CASH EQUIVALENTS AT END OF THE PERIOD | $ | 32,855 | $ | 20,528 | ||||
| APPENDIX A: | ||||||||
| Adjustments required to reflect net cash used in operating activities: | ||||||||
| Depreciation | $ | 60 | $ | 62 | ||||
| Interest income | (129 | ) | (22 | ) | ||||
| Exchange gains (losses) on cash and cash equivalents | (14 | ) | 73 | |||||
| Net changes in severance pay | – | 3 | ||||||
| Share-based payments | 583 | 408 | ||||||
| 500 | 514 | |||||||
| Changes in working capital : | ||||||||
| Decrease in other current assets | 99 | 257 | ||||||
| Decrease (increase) in long-term prepaid expenses | 148 | (418 | ) | |||||
| Increase (decrease) in accounts payable and accruals: Trade |
(735 | ) | 1,443 | |||||
| Other | 733 | (1,042 | ) | |||||
| 245 | 240 | |||||||
| $ | 745 | $ | 754 | |||||
CONTACT: INVESTOR CONTACT: Michael Rice LifeSci Advisors, LLC (646) 597-6979
