Initiated GLOBE™ pivotal Phase 3 trial of VB-111 in recurrent glioblastoma (rGBM)
Reported positive, final Phase 2 data of VBL-111 in rGBM at the European Cancer Conference (ECC) 2015
Raised $15 million gross proceeds in an underwritten offering, expected to fund operations through readout of results from the pivotal GLOBE trial
TEL AVIV, Israel, Nov. 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 financial results and provided a business update for the third quarter ended September 30, 2015.
"During the third quarter we reached an important milestone with initiation of our GLOBE™ study, the pivotal Phase 3 trial of VB-111 in recurrent glioblastoma (rGBM)," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "This trial is proceeding under a special protocol assessment (SPA) granted by the FDA and we have agreed with the agency that, if successful, this single Phase 3 trial will be sufficient for approval. We also reported the full Phase 2 Data from the Phase 2 clinical trial of VB-111 in rGBM at the European Cancer Conference. We are very encouraged by promising results reported with VB-111 to date and believe that it has the potential to change the treatment paradigm for rGBM patients, who are at great need for an effective therapy."
"Beyond rGBM, VB-111 has also shown promising efficacy signals in both recurrent, platinum-resistant ovarian cancer and progressive, differentiated thyroid cancer," continued Dr. Harats. "At the recent International Thyroid Conference, we reported positive results from our multi-cohort Phase 2 trial of VB-111 in advanced radioiodine-refractory differentiated thyroid cancer (RAIR-DTC), which achieved the primary endpoint of 6-month Progression Free Survival (PFS) for at least 25% of enrolled patients."
"Finally, we have strengthened our balance sheet with the successful completion, in November, of an underwritten offering, which raised $15 million in gross proceeds to VBL. The additional cash is expected to fund our operations until after the readout of the GLOBE results," said Dr. Harats.
Third Quarter and Recent Business Highlights:
- Initiated Pivotal Phase 3 GLOBE™ Study of VB-111 in Recurrent Glioblastoma (rGBM). The GLOBE™ Study is a Phase 3 trial of VB-111 in recurrent glioblastoma (rGBM), that is proceeding under a special protocol assessment (SPA) granted by the U.S. Food and Drug Administration (FDA). The trial is expected to enroll 252 patients with rGBM and will recruit patients from about 50 sites in the United States, Canada and Israel. The primary efficacy endpoint is overall survival.
- Reported Full Phase 2 Data from Clinical Trial of VB-111 in Recurrent Glioblastoma (rGBM) at the European Cancer Conference (ECC 2015): Trial met primary endpoint, showing statistically significant overall survival benefit. Patients treated with VB-111 in combination with Avastin™ upon disease progression (continuous exposure cohort) had a median overall survival (mOS) of 15 months, compared to mOS of 8 months in patients treated with VB-111 followed by Avastin™ alone (p=0.048). The company also reported, for the first time, an overall response rate (ORR) data of 29% with 2 complete responders in the continuous exposure cohort, compared to 9% with no complete responders in the limited exposure cohort.
- Reported Positive Results from the Multi-Cohort Phase 2 Trial of VB-111 in Advanced Radioiodine-Refractory Differentiated Thyroid Cancer (RAIR-DTC) at the 15th International Thyroid Congress: The pre-specified primary trial endpoint of 6-month Progression Free Survival (PFS) for at least 25% of enrolled patients was met, showing a dose response for VB-111. The trial also demonstrated favorable safety and survival data for VB-111, and a potential for dose-dependent disease stabilization.
- Completed an underwritten offering, raising $15 million in gross proceeds: On November 6th, the company closed an underwritten offering of 2.5 million ordinary shares together with accompanying warrants to purchase an aggregate of 1.25 million shares. The aggregate net proceeds from this offering were $14 million, after deducting underwriting discounts and commissions.
Third Quarter 2015 Financial Results:
- Cash Position: Cash, cash equivalents and short-term bank deposits as of September 30, 2015 were $27.6 million, compared to $36.8 million at year end 2014.
- R&D Expenses: Research and development expenses were $9.0 million for the nine-month period ended September 30, 2015, compared to $8.3 million in the comparable period in 2014. This budgeted-for increase in R&D expenses is attributable to the commencement of VB-111 Phase 3 trials offset by the cessation of our Phase 2 clinical development with VB-201.
- G&A Expenses: General and administrative expenses were $2.7 million for the nine-month period ended September 30, 2015, compared to $1.5 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 $5.8 million for the third quarter of 2015 and $11.7 million for the nine-month period ended September 30, 2015 compared to net loss of $3.5 million and $12.3 million, respectively, for the comparable periods in 2014. The increase in the net loss is attributable to the commencement of the GLOBE study and its related expenses. It is in line with our budgeted work plan.
Upcoming Events and Presentations:
- Society for Neurooncology (SNO), November 19-22, 2015 in San Antonio, Texas.
VBL Therapeutics will be hosting a conference call and webcast today, November 12, 2015, beginning at 8:30 a.m. U.S. Eastern Time.
|Conference Call Details:|
A live webcast of the call will be available online at http://edge.media-server.com/m/p/9hxy4fgd and on 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.
|Replays, available through November 26th:|
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' pivotal Phase 3 GLOBE trial of VB-111 in rGBM is ongoing under a special protocol assessment granted by the FDA.
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 the expected funding of operations from our underwritten offering in November 2015. 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 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|
|September 30,||December 31,|
|U.S. dollars in thousands|
|A s s e t s|
|Cash and cash equivalents||$11,965||$36,783|
|Short-term bank deposits||15,678||--|
|Other current assets||832||961|
|TOTAL CURRENT ASSETS||28,475||37,744|
|Property and equipment, net||307||358|
|Long-term prepaid expenses||385||36|
|TOTAL NON-CURRENT ASSETS||692||394|
|Liabilities and equity|
|CURRENT LIABILITIES --|
|TOTAL CURRENT LIABILITIES||5,110||2,930|
|NON-CURRENT LIABILITIES --|
|Severance pay obligations, net||105||106|
|TOTAL NON-CURRENT LIABILITIES||105||106|
|Other comprehensive income||39||39|
|Additional paid in capital||162,769||162,191|
|TOTAL LIABILITIES AND EQUITY||$29,167||$38,138|
|The accompanying notes are an integral part of these condensed financial statements.|
|VASCULAR BIOGENICS LTD.|
|CONDENSED INTERIM STATEMENT OF COMPREHENSIVE LOSS|
|Three months ended||Nine months ended|
|September 30||September 30|
|U.S dollars in thousands|
|RESEARCH AND DEVELOPMENT|
|GENERAL AND ADMINISTRATIVE|
|Loss from change in fair value of convertible|
|Other financial expenses||72||127||93||180|
|FINANCIAL EXPENSES (INCOME), net||52||126||41||2,517|
|COMPREHENSIVE LOSS||5,787||$ 3,515||$11,728||$ 12,272|
|LOSS PER ORDINARY SHARE,|
|basic and diluted||$0.29||$ 2.45||$0.59||$ 9.98|
|Number of shares||Number of shares|
|Weighted average ordinary share|
|outstanding – basic and diluted||19,927,241||1,435,425||19,913,489||1,229,968|
CONTACT: INVESTOR CONTACT: Michael Rice LifeSci Advisors, LLC (646) 597-6979
Source: VBL Therapeutics