TEL AVIV, Israel, Nov. 13, 2014 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq:VBLT), a clinical-stage biotechnology company committed to the discovery, development and commercialization of first-in-class treatments for cancer and immune-inflammatory diseases, today reported third quarter 2014 financial results.
"We are extremely pleased by our progress in the third quarter," said Dror Harats, chief executive officer of VBL. "We successfully completed our initial public offering, raising net proceeds of $34.9 million, and providing VBL with the financial resources to continue advancing the development of our rich oncology and inflammation pipelines. Earlier this morning, we released encouraging interim data from our Phase 2 trial of VB-111 in patients with recurrent glioblastoma (rGBM), and we remain on track to initiate a pivotal Phase 3 study in this indication in the first half of 2015. Additionally, we completed enrollment in two Phase 2 trials for VB-201 in psoriasis and ulcerative colitis, and look forward to reporting top-line results from these studies in the first quarter of 2015. We believe these successes reflect both the strength of our team and of our proprietary platform technologies, and underscore our continued commitment to advancing our programs expeditiously through the clinic."
Third Quarter and Recent Business Highlights:
- Presented positive interim results from VB-111 Phase 1/2 Study: Earlier today, VBL announced positive preliminary results from its ongoing Phase 2 trial of VB-111 in patients with recurrent glioblastoma (rGBM). Improved overall survival was suggestive 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.
- Completed enrollment in VB-201 Phase 2 Studies: In June, VBL announced completed enrollment of two Phase 2 studies evaluating the efficacy of lead Lecinoxoid compound VB-201 in psoriasis and ulcerative colitis. Top line results are expected in the first quarter of 2015.
- Completed Initial Public Offering: In September, VBL completed an initial public offering (IPO) of common stock, raising net proceeds of $34.9 million.
Third Quarter 2014 Financial Results:
- Cash Position: Cash and cash equivalents as of September 30, 2014 were $4.8 million, compared to $9.4 million at year end 2013. The decrease was primarily driven by investment in the Company's clinical development candidates. As of October 6, 2014 the Company recorded net proceeds of $34.9 million from the initial public offering of 6.8 million shares of the Company's common stock.
- R&D Expenses: Research and development expenses were $3.0 in the third quarter of 2014, compared to $3.1 million in the comparable period in 2013. The decrease in R&D expenses was largely due to a $0.7 million increase in the amount of OCS grants received in support of the Company's Lecinoxoid project.
- G&A Expenses: General and administrative expenses were $0.4 million in the third quarter of 2014, compared to $0.6 million in the comparable period in 2013. The decrease in G&A expenses was due primarily to a decrease in headcount, partially offset by an increase in travelling costs and other expenses.
- Net Loss: Net loss was $3.5 million for the third quarter of 2014, compared to net loss of $4.6 million for the comparable period in 2013.
Conference Call:
VBL Therapeutics will be hosting a conference call and webcast today, November 13, 2014, at 8:30 a.m. U.S. Eastern Time. The conference call may be accessed by dialing 877 280 2296 for domestic participants and 972 3721 9510 for international participants (reference conference ID 5690797). 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 clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of first-in-class treatments for cancer and immune-inflammatory diseases. VBL Therapeutics' clinical pipeline is based on two distinct, proprietary platform technologies—an oncology program and an anti-inflammatory program—that leverage the body's natural physiologic and genetic regulatory elements. 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 the first half of 2015, under a special protocol assessment agreement granted by the FDA. VBL Therapeutics' lead product candidate from its anti-inflammatory program, VB-201, is an oral small molecule currently being evaluated in Phase 2 clinical trials for psoriasis and for ulcerative colitis, with top-line results expected in the first quarter of 2015.
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) | ||
|
December 31, 2013 |
September 30, 2014 |
|
| (Audited) | (Unaudited) | |
| U.S. dollars in thousands | ||
| Assets | ||
| CURRENT ASSETS: | ||
| Cash and cash equivalents | $ 9,377 | $ 4,776 |
| Short-term bank deposits | 1,494 | -- |
| Other current assets | 507 | 3,501 |
| TOTAL CURRENT ASSETS | 11,378 | 8,277 |
| NON-CURRENT ASSETS: | ||
| Property and equipment, net | 436 | 384 |
| Long-term prepaid expenses | 13 | 27 |
| TOTAL NON-CURRENT ASSETS | 449 | 411 |
| TOTAL ASSETS | 11,827 | 8,688 |
| Liabilities and equity (capital deficiency) | ||
| CURRENT LIABILITIES: | ||
| Accounts payable: | ||
| Trade | 1,348 | 2,401 |
| Other | 2,897 | 3,133 |
| TOTAL CURRENT LIABILITIES | 4,245 | 5,534 |
| NON-CURRENT LIABILITIES: | ||
| Convertible loan | 31,039 | -- |
| Severance pay obligations, net | 126 | 118 |
| TOTAL NON-CURRENT LIABILITIES | 31,165 | 118 |
| TOTAL LIABILITIES | 35,410 | 5,652 |
| EQUITY (CAPITAL DEFICIENCY): | ||
| Ordinary Shares | 1 | 2 |
| Preferred Shares | 7 | 8 |
| Other comprehensive income | 29 | 29 |
| Additional paid in capital | 86,133 | 125,022 |
| Accumulated deficit | (109,753) | (122,025) |
| TOTAL EQUITY (CAPITAL DEFICIENCY) | (23,583) | 3,036 |
| TOTAL LIABILITIES AND EQUITY (CAPITAL DEFICIENCY) | 11,827 | 8,688 |
| VASCULAR BIOGENICS LTD. | ||||
| CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE LOSS | ||||
| (UNAUDITED) | ||||
|
Three months ended September 30, 2014 |
Nine months ended September 30, 2014 |
|||
| 2013 | 2014 | 2013 | 2014 | |
| U.S dollars in thousands | ||||
| RESEARCH AND DEVELOPMENT EXPENSES, NET | 3,129 | 2,966 | 9,541 | 8,278 |
| ADMINISTRATIVE AND GENERAL EXPENSES | 613 | 423 | 1,616 | 1,477 |
| OPERATING LOSS | 3,742 | 3,389 | 11,157 | 9,755 |
| FINANCIAL INCOME | (156) | (1) | (189) | (5) |
| FINANCIAL EXPENSES: | ||||
| Loss from change in fair value of convertible loan | 979 | -- | 979 | 2,342 |
| Other financial expenses | 6 | 127 | 16 | 180 |
| FINANCIAL EXPENSES, NET | 829 | 126 | 806 | 2,517 |
| COMPREHENSIVE LOSS | $ 4,571 | $ 3,515 | $ 11,963 | $ 12,272 |
| LOSS PER ORDINARY SHARE, | ||||
| basic and diluted | $ 4.16 | $ 2.45 | $ 10.89 | $ 9.98 |
| WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES USED IN COMPUTING LOSS | ||||
| PER SHARE – BASIC AND DILUTED | 1,098,239 | 1,435,425 | 1,098,239 | 1,229,968 |