VBL Therapeutics Announces Year Ended December 31, 2018 Financial Results and Provides Corporate Update
- Development of Phase 3 product candidate VB-111 continues in ovarian cancer toward interim analysis at year-end 2019 and expands through investigator-sponsored trials in rGBM and colon cancer
- Signed strategic agreement for VB-201 for veterinary use; potential payments to VBL may exceed €50 million
- MOSPD2 program: Proprietary monoclonal antibodies for inflammation demonstrate significant potential for MS, RA and NASH; Bi-specific antibodies are in development for oncology; IND filings expected in 2020
$50.5 millionin cash and cash equivalents at year-end 2018,sufficient to fund operations through 2021
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“We continue to advance our clinical program for VB-111 in ovarian cancer and are also exploring additional oncology indications,” said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. “The ongoing Phase 3 OVAL trial in platinum resistant ovarian cancer continues to enroll patients and we expect an interim efficacy readout by year end 2019.
“Recently, at the
“Based on these data on the potential ability for VB-111 to turn immunologically `cold` tumors `hot`, we expect the launch of a Phase 2 clinical trial with the
“We are also seeing renewed interest from the medical oncology community in the potential of VB-111 to treat recurrent Glioblastoma (rGBM) based on MRI analyses performed by
“We also have valuable pipeline assets, including our MOSPD2 antibody programs in inflammation and oncology, as well as VB-201, for which we have recently signed a strategic exclusive option license agreement for veterinary use, with potential payments to VBL that may exceed €50 million during the license term.”
“We had more than
Fourth Quarter and Recent Corporate Highlights:
- Executed a strategic exclusive option license agreement with one of the world-leading European animal health companies, for the development of VBL’s proprietary anti-inflammatory molecule, VB-201, for veterinary use. VBL is receiving an undisclosed up-front payment and upon exercising the option to license, VBL will receive additional milestones and royalties, which may exceed €50 million. VBL retains worldwide rights for the use of VB-201 for the treatment of humans.
- Presented new data at the
Society of Gynecologic Oncology(SGO) 50th Annual Meeting on Women's Cancer demonstrating the potential of VB-111 to stimulate the immune system and drive immune cells to infiltrate the tumor microenvironment, switching tumors from immunologically `cold` to `hot`.
- Presented new analysis from the Phase 3 GLOBE study of VB-111 in patients with rGBM at the 2018
Society for Neuro-Oncology(SNO) annual meeting. New data provided insight into how the VB-111 treatment regimen may influence its anti-tumor activity, and thus why use of Avastin without prior priming with VB-111 monotherapy can block VB-111 activity. This likely explains why the positive Phase 2 data in rGBM were not replicated in the GLOBE Phase 3 study.
- Presented new data on the potential of VB-600 platform of antibodies targeting MOSPD2 for treatment of various inflammatory indications, including multiple sclerosis (MS), nonalcoholic steatohepatitis (NASH) and rheumatoid arthritis (RA) at the Keystone Symposia on Myeloid Cells. An Investigational New Drug (IND) application for MOSPD2 mAb for treatment of inflammatory indications is planned for submission in 2020.
- Published a manuscript demonstrating MOSPD2 as a key player in breast cancer metastasis and a potential target for treatment of solid tumors. Earlier in 2018, VBL presented a late-breaking study at the American Association for Cancer Research (AACR) 2018 Annual Meeting, demonstrating a novel bi-specific antibody that induces immune-cell mediated killing of cancer cells through binding MOSPD2. An IND application for bi-specific antibody for treatment of solid tumor indications is planned for 2H2020.
- Awarded a non-dilutive grant of over 10 million New Israeli Shekels (approximately
$2.9 million) by the Israel Innovation Authority(IIA), to support continued development of VB-111 for 2019.
Fiscal Year Ended
- Revenues: Revenues related to the VBL’s collaboration in
Japanamounted to $0.6 millionin the year ended December 31, 2018.
- Cash Position: At
December 31, 2018, VBL had cash, cash equivalents and short-term bank deposits of $50.5 millionand working capital of $47.0 million. VBL expects that its cash and cash equivalents and short-term bank deposits will be sufficient to fund operating expenses and capital expenditure requirements through 2021.
- R&D Expenses: Research and development expenses, net, after government grants, for the year ended
December 31, 2018, were approximately $15.9 million, compared to approximately $17.8 millionin the same period in 2017.
- G&A Expenses: General and administrative expenses for the year ended
December 31, 2018were $5.2 million, compared to $5.8 millionfor the same period in 2017.
- Comprehensive Loss: VBL reported a net loss for year ended
December 31, 2018, of $20.4 million, or ($0.62)per share, compared to a net loss of $10.2 million, or ($0.37)per share, in the year ended December 31, 2017.
For further details on VBL’s financials, please refer to Form 20-F filed with the
From the US 877-407-9208
Conference ID: 13687581
Forward Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. These forward-looking statements include, but are not limited to, statements regarding our programs, including VB-111, including their clinical development, such as the timing of clinical trials and expected announcement of data, therapeutic potential and clinical results, the intended benefits of our collaboration for VB-201, including potential milestone and royalty payments, and our financial position and cash runway. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, the risk that historical clinical trial results may not be predictive of future trial results, that our financial resources do not last for as long as anticipated, and that we may not realize the expected benefits of our intellectual property protection. A further list and description of these risks, uncertainties and other risks can be found in our regulatory filings with the
STATEMENTS OF FINANCIAL POSITION
|U.S. dollars in thousands|
|Cash and cash equivalents||$||29,347||$||6,694|
|Short-term bank deposits||21,135||48,035|
|Other current assets||1,227||1,729|
|TOTAL CURRENT ASSETS||51,709||58,458|
|Property and equipment, net||8,921||7,128|
|Long-term prepaid expenses||48||103|
|TOTAL NON-CURRENT ASSETS||8,969||7,231|
|Liabilities and equity|
|TOTAL CURRENT LIABILITIES||4,774||7,569|
|Severance pay obligations, net||99||128|
|TOTAL NON-CURRENT LIABILITIES||2,811||2,220|
|Ordinary shares, NIS 0.01 par value; Authorized as of December 31,
2018 and 2017, 70,000,000 shares; issued and outstanding as of
December 31, 2018 and 2017, 35,881,128 and 29,879,323 shares,
|Accumulated other comprehensive income||41||16|
|Additional paid in capital||233,721||221,055|
|TOTAL LIABILITIES AND EQUITY||$||60,678||$||65,689|
STATEMENTS OF COMPREHENSIVE LOSS
|Year ended December 31|
|U.S. dollars in thousands|
|COST OF REVENUES||(235||)||(340||)||-|
|RESEARCH AND DEVELOPMENT EXPENSES, net||$||15,940||$||17,770||$||12,447|
|GENERAL AND ADMINISTRATIVE EXPENSES||5,220||5,847||3,828|
|FINANCIAL (INCOME), net||(749||)||(517||)||(273||)|
|LOSS FOR THE YEAR||20,458||10,138||16,002|
|OTHER COMPREHENSIVE LOSS (INCOME)-|
|Items that will not be reclassified to profit or loss-|
|Re-measurements of post-employment benefit
|LOSS PER ORDINARY SHARE|
|Basic and diluted||$||0.62||$||0.37||$||0.64|
|Number of shares|
|WEIGHTED AVERAGE ORDINARY SHARES
|Basic and diluted||32,969,094||27,398,169||24,970,585|