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 million in cash and cash equivalents at year-end 2018,sufficient to fund operations through 2021
Conference Call and Webcast at 8:30am Eastern Time Today
TEL AVIV, Israel, March 28, 2019 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT) today announced financial results for the year ended December 31, 2018, and provided a corporate update.
“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 Society of Gynecologic Oncology (SGO) conference, we presented data showing that in 3 out of 3 ovarian cancer patients from whom we obtained tumor biopsies, including a Phase 3 patient who was enrolled in the early unblinded stage of the Phase 3 OVAL study, VB-111 resulted in recruitment of infiltrating T-cells into the tumor, turning it from `cold` to `hot`. This important finding suggests that VB-111 may be applied to other `cold` tumors, in which checkpoint inhibitors show limited or no efficacy. Furthermore, although limited, we are encouraged that in the open label part of the Phase 3 study, data seem to recapitulate the activity of VB-111 in our prior Phase 2 trial for ovarian cancer.
“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 National Cancer Institute (NCI), exploring VB-111 in colon cancer in combination with a checkpoint inhibitor, in the second half of 2019.
“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 UCLA. Accordingly, recruitment in an investigator-sponsored study for VB-111 in rGBM is expected to commence in Q2 2019. This study will be conducted at top neuro-oncology centers in the US. Therefore, toward late 2019 we expect there will be three ongoing clinical trials of VB-111, in ovarian cancer, colon cancer and rGBM.
“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 $50 million in cash and cash equivalents at December 31, 2018. This is expected to provide us with sufficient resources to continue to develop VB-111 and other product candidates and to fund our operating expenses and capital expenditure requirements through 2021,” said Amos Ron, Chief Financial Officer of VBL Therapeutics.
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 December 31, 2018 Financial Results:
Revenues: Revenues related to the VBL’s collaboration in Japan amounted to $0.6 million in 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 million and 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 million in the same period in 2017.
G&A Expenses: General and administrative expenses for the year ended December 31, 2018 were $5.2 million, compared to $5.8 million for 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 SEC.
Conference Call: Thursday, March 28th @ 8:30am Eastern Time From the US 877-407-9208 International: 201-493-6784 Conference ID: 13687581 Webcast: https://edge.media-server.com/m6/p/izv665bj
About VBL Vascular Biogenics Ltd., operating as VBL Therapeutics, is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class treatments for cancer. VBL’s lead oncology product candidate, ofranergene obadenovec (VB-111), is a first-in-class, targeted anti-cancer gene-therapy agent that is being developed to treat a wide range of solid tumors. It is conveniently administered as an IV infusion once every two months. It has been observed to be well-tolerated in >300 cancer patients and demonstrated activity signals in an “all comers” Phase 1 trial as well as in three tumor-specific Phase 2 studies. Ofranergene obadenovec is currently being studied in a Phase 3 potential registration trial for platinum-resistant ovarian cancer.
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 U.S. Securities and Exchange Commission, including in our annual report on Form 20-F for the year ended December 31, 2018, and subsequent filings with the SEC. 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.
INVESTOR CONTACT: Michael Rice LifeSci Advisors [email protected] (646) 597-6979
VASCULAR BIOGENICS LTD. STATEMENTS OF FINANCIAL POSITION
December 31
2018
2017
U.S. dollars in thousands
Assets
CURRENT ASSETS:
Cash and cash equivalents
$
29,347
$
6,694
Short-term bank deposits
21,135
48,035
Trade receivables
-
2,000
Other current assets
1,227
1,729
TOTAL CURRENT ASSETS
51,709
58,458
NON-CURRENT ASSETS:
Property and equipment, net
8,921
7,128
Long-term prepaid expenses
48
103
TOTAL NON-CURRENT ASSETS
8,969
7,231
TOTAL ASSETS
$
60,678
$
65,689
Liabilities and equity
CURRENT LIABILITIES-
Accounts payable:
Trade
$
1,193
$
3,058
Other
2,944
3,465
Deferred revenue
290
1,046
Lease liability
347
-
TOTAL CURRENT LIABILITIES
4,774
7,569
NON-CURRENT LIABILITIES-
Severance pay obligations, net
99
128
Deferred revenue
2,263
2,092
Lease liability
449
-
TOTAL NON-CURRENT LIABILITIES
2,811
2,220
TOTAL LIABILITIES
7,585
9,789
COMMITMENTS
EQUITY:
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, respectively
73
57
Accumulated other comprehensive income
41
16
Additional paid in capital
233,721
221,055
Warrants
7,904
2,960
Accumulated deficit
(188,646
)
(168,188
)
TOTAL EQUITY
53,093
55,900
TOTAL LIABILITIES AND EQUITY
$
60,678
$
65,689
VASCULAR BIOGENICS LTD. STATEMENTS OF COMPREHENSIVE LOSS
Year ended December 31
2018
2017
2016
U.S. dollars in thousands
REVENUES
585
13,864
-
COST OF REVENUES
(235
)
(340
)
-
GROSS PROFIT
350
13,524
-
RESEARCH AND DEVELOPMENT EXPENSES, net
$
15,940
$
17,770
$
12,447
MARKETING EXPENSES
397
562
-
GENERAL AND ADMINISTRATIVE EXPENSES
5,220
5,847
3,828
OPERATING LOSS
21,207
10,655
16,275
FINANCIAL INCOME
(908
)
(544
)
(285
)
FINANCIAL EXPENSES
159
27
12
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 obligation
