TEL AVIV, Israel, Nov. 14, 2019 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT) today announced financial results for the third quarter ended September 30, 2019, and provided a corporate update.
“Our OVAL Phase 3 potential-registration trial of VB-111 in ovarian cancer is progressing well and we look forward to an important interim analysis expected in the first quarter of 2020,” said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. “The interim analysis will be based on CA-125 response, a disease marker which correlated with survival benefit in our Phase 2 study in platinum-resistant ovarian cancer patients. We also look forward to the launch of an investigator-sponsored trial of VB-111 in recurrent GBM and an NCI-sponsored trial in colon cancer, expected before the end of 2019.”
Third Quarter and Recent Corporate Highlights:
- An investigational new drug (IND) application for an investigator-sponsored Phase 2 trial of VB-111 in recurrent glioblastoma (“rGBM”) went into effect with the U.S. Food and Drug Administration (FDA). The IND was submitted by Dana-Farber Cancer Institute, on behalf of a group of top neuro-oncology US medical centers. Further details on the trial will be presented at the upcoming Annual Meeting and Education Day of the Society for Neuro-Oncology, to take place November 20 - 24, 2019 at the Marriott Desert Ridge Hotel, Phoenix, Arizona.
- An NCI-sponsored trial of VB-111 in colon cancer is expected to begin by year-end 2019. Based on the potential of VB-111 to turn immunologically “cold” tumors “hot”, as seen in ovarian cancer biopsies, the new study will evaluate for the first time a combination of VB-111 and a checkpoint inhibitor in colon cancer, a cold tumor in which checkpoints inhibitor are ineffective for the vast majority of patients.
- VBL’s new gene therapy pharmaceutical grade manufacturing facility in Modiin, Israel, that was established to support the commercial supply of VB-111 for the first indication, was certified by a European Union (EU) Qualified Person (QP) as being in compliance with EU Good Manufacturing Practices (GMP). This important step is expected to support future commercialization of VB-111, if approved.
- VBL continues to advance the development of lead MOSPD2 antibodies towards IND applications in inflammation and in oncology, expected by year-end 2020. The Company has signed a service agreement with Thermo Fisher Scientific, one of the leading vendors in the antibody field, for production of lead candidate VB-601 for toxicology and clinical development.
Third Quarter ended September 30, 2019 Financial Results:
- Cash Position: At September 30, 2019, the Company had cash, cash equivalents, short-term bank deposits and restricted bank deposits totaling $41.1 million and working capital of $34.5 million. The Company expects that its cash, cash equivalents and short-term bank deposits will enable it to fund operating expenses and capital expenditure requirements for approximately two years.
- Revenues: Revenues related to VBL’s collaborations were $0.1 million in the third quarter of 2019.
- R&D Expenses: Research and development expenses, net, after government grants, were approximately $3.8 million for the quarter ended September 30, 2019, compared to approximately $4.1 million in the same period in 2018.
- G&A Expenses: General and administrative expenses for the quarter ended September 30, 2019 were $1.2 million, compared to approximately $1.4 million in the same period in 2018.
- Comprehensive Loss: VBL reported a net loss for the quarter ended September 30, 2019 of $4.9 million, or ($0.14) per share, compared to a net loss of $5.4 million, or ($0.15) per share, in the quarter ended September 30, 2018.
For further details on VBL’s financials, please refer to Form 6-K filed with the SEC.
Conference Call: Thursday, November 14th @ 8:30am Eastern Time
| From the US: | 877-407-9208 |
| International: | 201-493-6784 |
| Conference ID: | 13696234 |
| Webcast: | https://edge.media-server.com/mmc/p/2s8reh2m |
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 and immune-inflammatory indications. 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, their clinical development, such as the timing of clinical trials and expected announcement of data, therapeutic potential and clinical results, 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
mrice@lifesciadvisors.com
(646) 597-6979
VASCULAR BIOGENICS LTD.
CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION
(UNAUDITED)
| September 30, 2019 | December 31, 2018 | |||||||
| U.S. dollars in thousands | ||||||||
| Assets | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 22,319 | $ | 29,347 | ||||
| Short-term bank deposits | 18,231 | 21,135 | ||||||
| Other current assets | 1,636 | 1,227 | ||||||
| TOTAL CURRENT ASSETS | 42,186 | 51,709 | ||||||
| NON-CURRENT ASSETS: | ||||||||
| Restricted bank deposits | 503 | - | ||||||
| Property and equipment, net | 7,197 | 8,921 | ||||||
| Right-of-use assets | 3,253 | - | ||||||
| Long-term prepaid expenses | - | 48 | ||||||
| TOTAL NON-CURRENT ASSETS | 10,953 | 8,969 | ||||||
| TOTAL ASSETS | $ | 53,139 | $ | 60,678 | ||||
| Liabilities and equity | ||||||||
| CURRENT LIABILITIES- | ||||||||
| Accounts payable and accruals: | ||||||||
| Trade | $ | 1,263 | $ | 1,193 | ||||
| Other | 5,256 | 2,944 | ||||||
| Deferred revenue | 377 | 290 | ||||||
| Lease liabilities | 791 | 347 | ||||||
| TOTAL CURRENT LIABILITIES | 7,687 | 4,774 | ||||||
| NON-CURRENT LIABILITIES- | ||||||||
| Severance pay obligations, net | 106 | 99 | ||||||
| Deferred revenue | 1,858 | 2,263 | ||||||
| Lease liabilities | 2,333 | 449 | ||||||
| TOTAL NON-CURRENT LIABILITIES | 4,297 | 2,811 | ||||||
| TOTAL LIABILITIES | 11,984 | 7,585 | ||||||
| EQUITY: | ||||||||
| Ordinary shares | 73 | 73 | ||||||
| Accumulated other comprehensive income | 41 | 41 | ||||||
| Additional paid in capital | 235,511 | 233,721 | ||||||
| Warrants | 7,904 | 7,904 | ||||||
| Accumulated deficit | (202,374 | ) | (188,646 | ) | ||||
| TOTAL EQUITY | 41,155 | 53,093 | ||||||
| TOTAL LIABILITIES AND EQUITY | $ | 53,139 | $ | 60,678 | ||||
VASCULAR BIOGENICS LTD.
CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(UNAUDITED)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||||||||
| U.S. dollars in thousands | ||||||||||||||||||||||
| REVENUES | $ | 79 | $ | 101 | $ | 436 | $ | 444 | ||||||||||||||
| COST OF REVENUES | (30 | ) | (44 | ) | (118 | ) | (188 | ) | ||||||||||||||
| GROSS PROFIT | 49 | 57 | 318 | 256 | ||||||||||||||||||
| RESEARCH AND DEVELOPMENT EXPENSES, net | $ | 3,795 | $ | 4,137 | $ | 10,832 | $ | 12,792 | ||||||||||||||
| MARKETING EXPENSES | - | 151 | - | 575 | ||||||||||||||||||
| GENERAL AND ADMINISTRATIVE EXPENSES | 1,232 | 1,406 | 3,669 | 3,972 | ||||||||||||||||||
| OPERATING LOSS | 4,978 | 5,637 | 14,183 | 17,083 | ||||||||||||||||||
| FINANCIAL INCOME | (223 | ) | (387 | ) | (722 | ) | (640 | ) | ||||||||||||||
| FINANCIAL EXPENSES | 101 | 102 | 267 | 142 | ||||||||||||||||||
| FINANCIAL INCOME, net | (122 | ) | (285 | ) | (455 | ) | (498 | ) | ||||||||||||||
| COMPREHENSIVE LOSS | $ | 4,856 | $ | 5,352 | $ | 13,728 | $ | 16,585 | ||||||||||||||
| LOSS PER ORDINARY SHARE | U.S. dollars | |||||||||||||||||||||
| Basic and diluted | $ | 0.14 | $ | 0.15 | $ | 0.38 | $ | 0.52 | ||||||||||||||
| Number of shares | ||||||||||||||||||||||
| WEIGHTED AVERAGE ORDINARY SHARES OUTSTANDING- | ||||||||||||||||||||||
| Basic and diluted | 35,881,128 | 35,865,050 | 35,881,128 | 31,987,750 | ||||||||||||||||||