- Will host conference call at 8:30 am ET today-
-Also announced positive top-line interim results for Phase 2b trial testing VB-111 in recurrent glioblastoma-
TEL AVIV, Israel, March 25, 2015 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq:VBLT), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, today reported business highlights and financial results for the fourth quarter and year ended December 31, 2014.
“2014 was a transformative year for VBL. We continue to be encouraged by the clinical activity observed in our Phase 2 studies of VB-111 across numerous recurrent cancer indications, which bolsters our confidence in the unique mechanism of VB-111 and the strength of our Vascular Targeting System (VTS) platform technology,” said Dror Harats, M.D., Chief Executive Officer of VBL. “Having completed our initial public offering late last year, we are well positioned to continue advancing our pipeline. We look forward to initiating a pivotal Phase 3 study of VB-111 in recurrent glioblastoma (rGBM) in mid-2015, the single one required by our a special protocol assessment agreed upon with the U.S. Food and Drug Administration (FDA). In addition, we plan to provide an update on our ongoing, open-label Phase 2 trial of VB-111 in rGBM in conjunction with the ASCO Annual Meeting in June, including additional data on the statistically significant improvements in overall survival announced this morning.”
Fourth Quarter and Recent Business Highlights:
Oncology Programs:
- Announced statistically significant interim top-line results from VB-111 Phase 1/2 Study: Earlier today, VBL announced positive interim top-line results from its ongoing Phase 2 trial of VB-111 in patients with 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.
- Presented positive top-line results from VB-111 Phase 2a Study: VBL announced positive results from its exploratory Phase 2a trial of VB-111 in patients with recurrent, iodine-resistant differentiated thyroid cancer. VB-111 provided disease stabilization and safety in patients who previously progressed after several lines of treatment, and demonstrated a favorable safety profile.
Inflammation Programs:
- Received European Patent Issuance on Lecinoxoid Platform Technology: VBL announced the issuance by the European Patent Office of Patent No. 2348866, covering the compound, pharmaceutical composition, and use of second generation oral Lecinoxoids.
- Presented top-line results from VB-201 Phase 2 Studies: Also in February, VBL announced that its Phase 2 studies evaluating Lecinoxoid compound VB-201 in patients with psoriasis and ulcerative colitis did not meet their primary endpoints. VBL does not plan to continue development of VB-201 in these indications.
Corporate:
- 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.
- Completed Initial Public Offering: In October, VBL closed its initial public offering (IPO) of common stock, raising net proceeds of $34.9 million.
Fourth Quarter and Full Year Ended December 31, 2014 Financial Results:
- Cash Position: Cash and cash equivalents as of December 31, 2014 were $36.8 million, compared to $9.4 million at year end 2013.
- R&D Expenses: Research and development expenses were $11.0 million for the year ended December 31, 2104, compared to $13.1 million for the same period last year. The decrease in R&D expenses was largely due to a $1.0 million increase in the amount of grants received from the Israeli Office of the Chief Scientist in support of the Company’s Lecinoxoid project and a reduction in VB-111 clinical expenses.
- G&A Expenses: General and administrative expenses were $3.8 million for the year ended December 31, 2014, compared to $2.5 million for the same period last year. The increase in G&A expenses was due primarily to payroll related costs associated with share-based compensation.
- Net Loss: Net loss for the full year ended December 31, 2014 was $14.8 million, compared to net loss of $16.0 million for the same period last year.
Financial Guidance:
Based on current operating plans, VBL expects to have sufficient cash to fund operations through at least 2016.
Conference Call:
VBL Therapeutics will be hosting a conference call and webcast today, March 25, 2015, at 8:30 a.m. U.S. Eastern Time. The conference call may be accessed by dialing 1-877-280-1254 for domestic participants and 972-3-721-9510 for international participants (reference conference ID 9987278). 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. In particular, results from our proposed 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 our current clinical trial. 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. | ||
| Consolidated Statements of Financial Position | ||
| December 31, | ||
| 2014 | 2013 | |
| Statement of financial position data: | (in thousands) | |
| Cash and cash equivalents and short-term bank deposits | $ 36,783 | $ 10,871 |
| Total Assets | 37,744 | 11,827 |
| Total Liabilities | 3,036 | 35,410 |
| Total equity (Capital deficiency) | 35,102 | (23,582) |
| Vascular Biogenics Ltd. | ||
| Consolidated Statements of Comprehensive Loss | ||
| December 31, | ||
| (in thousands, except share and per-share data) | ||
| 2014 | 2013 | |
| Research and development expenses, net | $ 10,974 | $ 13,058 |
| General and administrative expenses | 3,804 | 2,452 |
| Operating loss | 14,778 | 15,960 |
| Financial income | (15) | (240) |
| Financial expenses: | ||
| Loss from change in fair value of convertible loan | 2,342 | 1,638 |
| Other financial expenses | 302 | 12 |
| Financial expenses (income), net | 2,629 | 1,410 |
| Other comprehensive income | (10) | (22) |
| Comprehensive Loss | $ 17,397 | $ 17,348 |
| Loss per ordinary share, basic and diluted (1) | $ 3.09 | $ $15.82 |
| Weighted average ordinary shares outstanding, basic and diluted (1) | 5,627,324 | 1,098,248 |
| Comprehensive Loss | $ 17,397 | $ 17,348 |
| Loss from change in fair value of convertible loan | (2,432) | (1,638) |
| Onetime expense related to the IPO grant of options to the CEO | (2,249) | |
| Non-GAAP loss | $ 12,806 | $ 15,710 |
| Non-GAAP loss per share attributable to ordinary shareholders, basic and diluted (2) | $ 0.64 | $ 1.34 |
| Pro-forma ordinary shares as on-converted basis | 19,898,674 | 11,708,932 |
| Vascular Biogenics Ltd. | ||||||||
| Non-GAAP Quarterly Loss Per Share | ||||||||
| Non-GAAP quarterly loss per share (2) | ||||||||
| Three months ended | ||||||||
| March 31, 2014 | June 30, 2014 | September 30, 2014 | December 31, 2014 | |||||
| Loss per share | $4.47 | $3.36 | $2.86 | $0.25 | ||||
| Non-GAAP loss per share | $0.23 | $0.29 | $0.27 | $0.14 | ||||
| (1) Refers to the GAAP calculation of the number of shares: “Weighted average ordinary shares outstanding, basic and diluted.” | ||||||||
| (2) Refers to the non-GAAP calculation of the number of shares: “Pro-forma ordinary shares on as-converted basis.” | ||||||||
CONTACT: Hannah Deresiewicz Stern Investor Relations, Inc. (212) 362-1200, hannahd@sternir.com
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