— Reported Strengthened, Statistically Significant Interim Data From VB-111 Phase 2 Study in rGBM —
— Reported Clinically Meaningful Interim Data From VB-111 Phase 1/2a Study in Platinum-Resistant Ovarian Cancer —
— Presented Data on Proprietary Gene Therapy Vascular Targeting System™ —
— Announces Successful Pre-Clinical Trial Application (CTA) Meeting With Health Canada —
TEL AVIV, Israel, Aug. 13, 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 financial results and provided a business update for the second quarter ended June 30, 2015.
“During the quarter we were very pleased to announce interim data results from our ongoing studies of lead product candidate VB-111 in recurrent glioblastoma (rGBM) and platinum-resistant ovarian cancer, which demonstrated statistically significant improvements in overall survival and evidence of clinical benefit in patients, respectively,” said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. “These promising data bolster our confidence in VB-111 as a potential treatment option for patients with debilitating solid tumor cancers. We look forward to initiating our GLOBE™ Study, the singly-needed pivotal Phase 3 trial of VB-111 in rGBM shortly, which is proceeding under a special protocol assessment granted by the U.S. Food and Drug Administration (FDA).”
VBL Therapeutics also announced a successful pre-clinical trial application (CTA) meeting with Health Canada’s Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics (CERB), held in support of VBL’s GLOBE Study. The meeting took place with the support of the Canadian Brain Tumor Consortium (CBTC), headed by Dr. James Perry, who stated that the GLOBE Study received the CBTC’s full endorsement. At the meeting, the CERB team expressed its support of VBL’s investigational medicinal product dossier (IMPD), and declared it adequate to support a Canadian CTA. The study will enroll approximately one third of its patients in Canada and Israel.
Second Quarter and Recent Business Highlights:
- Presented updated interim results from VB-111 Phase 2 study in recurrent glioblastoma (rGBM): At the Drug Discovery and Therapy World Congress (DDTWC) 2015 in July, VBL announced updated interim results from its ongoing Phase 2 study of VB-111 in patients with rGBM, which showed a strengthened, statistically significant overall survival in patients treated with VB-111 followed by VB-111 in combination with bevacizumab (Avastin®) upon disease progression, compared to patients treated with VB-111 followed by bevacizumab alone (median overall survival of 16 vs. 8 months, p=0.05). VBL remains on track to initiate the pivotal Phase 3 study in rGBM shortly, under a special protocol assessment granted by the FDA.
- Presented data on proprietary gene therapy Vascular Targeting System™ (VTS): Also at DDTWC, VBL presented data on VTS, its proprietary gene therapy technology which enables targeted and specific expression of a gene of choice in angiogenic blood vessels through unique “super enhancer” DNA regulatory sequences.
- Presented positive interim results from VB-111 Phase 1/2a study in platinum-resistant ovarian cancer: At the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting in June, VBL announced promising interim results from the Phase 2, investigator-initiated trial of multiple dose VB-111 in patients with recurrent, platinum-resistant ovarian cancer. The data demonstrated evidence of clinical benefit in patients who received VB-111 in conjunction with weekly paclitaxel, with 60% response rate of high-dose patients meeting the CGIC response criteria based on a reduction of at least 50% in the CA-125 tumor-marker levels.
Second Quarter 2015 Financial Results:
- Cash Position: Cash, cash equivalents and short term deposits as of June 30, 2015 were $31.5 million, compared to $36.8 million at year end 2014.
- R&D Expenses: Research and development expenses were $4.0 million for the 6 months period ended June 30, 2015, compared to $5.3 million in the comparable period in 2014. This decrease in R&D expenses is attributable to the cessation of our Phase 2 clinical trials with VB-201.
- G&A Expenses: General and administrative expenses were $1.9 million for the 6 months period ended June 30, 2015, compared to $1.1 million in the comparable period in 2014. This increase in G&A expenses is due primarily to costs associated with running a public company.
- Net Loss: Net loss was $3.0 million for the second quarter of 2015 and $5.9 for the 6 months period ended June 30, 2015 compared to net loss of $3.7 million and $8.8 million, respectively, for the comparable periods in 2014.
Upcoming Events and Presentations:
- European Cancer Congress (ECCO/ESMO), September 25-29, 2015 in Vienna, Austria
- International Thyroid Congress (ITC), October 18-23, 2015 in Lake Buena Vista, Florida
- Society for Neurooncology (SNO), November 19-22, 2015 in San Antonio, Texas
VBL Therapeutics will be hosting a conference call and webcast today, August 13, 2015, at 8:30 a.m. U.S. Eastern Time. The conference call may be accessed by dialing 1-646-254-3364 (domestic) or +972-3-763-0147 (international) and refer to conference ID 7639030. 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.
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. 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 clinical trial of VB-111 in rGBM shortly, under a special protocol assessment 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.|
|CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION|
|U.S. dollars in thousands|
|Cash and cash equivalents||$ 20,528||$ 36,783|
|Short-term bank deposits||11,020|
|Other current assets||704||961|
|TOTAL CURRENT ASSETS||32,252||37,744|
|Property and equipment, net||332||358|
|Long-term prepaid expenses||454||36|
|TOTAL NON-CURRENT ASSETS||786||394|
|Liabilities and equity|
|TOTAL CURRENT LIABILITIES||3,331||2,930|
|severance pay obligations, net||109||106|
|TOTAL NON-CURRENT LIABILITIES||109||106|
|Other comprehensive income||39||39|
|Additional paid in capital||162,628||162,191|
|TOTAL LIABILITIES AND EQUITY||$ 33,038||$ 38,138|
|VASCULAR BIOGENICS LTD.|
|CONDENSED INTERIM STATEMENT OF COMPREHENSIVE LOSS|
Three months ended
Six months ended
|U.S. dollars in thousands|
|RESEARCH AND DEVELOPMENT EXPENSES, net||$ 1,989||$ 2,964||$ 4,019||$ 5,311|
|GENERAL AND ADMINISTRATIVE EXPENSES||1,134||477||1,933||1,053|
|Loss from change in fair value of convertible Loan||—||243||—||2,341|
|Other financial expenses||(142)||17||21||55|
|FINANCIAL EXPENSES (INCOME), net||(159)||259||(11)||2,391|
|LOSS PER ORDINARY SHARE, basic and diluted||$ 0.15||$ 3.23||$ 0.30||$ 7.78|
|Number of shares||Number of shares|
|Weighted average ordinary share outstanding – basic and diluted||19,914,538||1,144,523||19,906,562||1,125,536|
CONTACT: Hannah Deresiewicz Stern Investor Relations, Inc. (212) 362-1200, [email protected]