TEL AVIV, Israel, May 15, 2019 (GLOBE NEWSWIRE) -- VBL Therapeutics VBLT today announced financial results for the first quarter ended March 31, 2019, and provided a corporate update.
"As we continue to advance development of VB-111, we are getting a better understanding of its mechanism of action and how best to incorporate it into oncology treatment regimens," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "We expect two additional VB-111 clinical trials to begin this year, a Phase 2 trial in colon cancer in combination with a checkpoint inhibitor (in collaboration with the National Cancer Institute) and an investigator-sponsored study in recurrent glioblastoma which will be conducted by a group of top US neuro-oncology centers. Therefore, together with the ongoing Phase 3 OVAL pivotal study in ovarian cancer, there will be a total of three VB-111 clinical trials up and running in the second half of 2019.
We are also pleased to announce that there will be two presentations on VB-111 at the upcoming 2019 ASCO Annual Meeting in early June, by Dr. Richard Penson from Massachusetts General Hospital on the final Phase 2 results in ovarian cancer, and by Dr. Benjamin Ellingson from UCLA on VB-111 Phase 2 and Phase 3 MRI data in recurrent GBM.
In addition to advancing VB-111, we are also moving forward with two parallel development programs targeting MOSPD2, which has significant potential as a therapeutic target for both inflammatory diseases and cancer."
"We had $47.7 million in cash and cash equivalents at March 31, 2019, which we believe is sufficient to continue development of 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.
First 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 received an undisclosed up-front payment and upon exercising the option to license, VBL expects to 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. |
| ● | 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. |
| ● | Presented new data indicating that VB-111 has potential to stimulate the immune system to induce a strong and durable response against ovarian tumors at the Society for Gynecologic Oncology 50th Annual Meeting on Women's Cancer. The Company's ongoing potential registration OVAL pivotal trial in platinum resistant ovarian cancer continues to enroll patients as planned. |
| ● | MOSPD2 program for inflammation: Presented new data at the Keystone Symposia on the role of MOSPD2 in the migration of certain inflammatory cells, the myeloid cells. VBL is developing the VB-600 platform of antibodies targeting MOSPD2 for treatment of various inflammatory indications. |
| ● | MOSPD2 oncology program: VBL is currently developing bi-specific antibodies that bring together tumor cells, via MOSPD2, and T cells, via CD3, to recruit the immune system to fight tumor cells. |
First Quarter ended March 31, 2019 Financial Results:
| ● | Cash Position: At March 31, 2019, the Company had cash, cash equivalents and short-term bank deposits totaling $47.7 million and working capital of $43.1 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 through 2021. |
| ● | Revenues: Revenues related to VBL's collaborations were $0.2 million in the first quarter of 2019. |
| ● | R&D Expenses: Research and development expenses, net, after government grants, for the quarter ended March 31, 2019, were approximately $3.3 million, compared to approximately $5.8 million in the same period in 2018. |
| ● | G&A Expenses: General and administrative expenses for the quarter ended March 31, 2019 were $1.3 million, compared to $1.4 million for the same period in 2018. |
| ● | Comprehensive Loss: VBL reported a net loss for the first quarter ended March 31, 2019, of $4.2 million, or ($0.12) per share, compared to a net loss of $7.2 million, or ($0.24) per share, in the quarter ended March 31, 2018. |
For further details on VBL's financials, please refer to Form 6-K filed with the SEC.
Conference Call:
Wednesday, May 15th @ 8:30am Eastern Time
From the US: 877-407-9208
International: 201-493-6784
Conference ID: 13690495
Webcast: https://edge.media-server.com/m6/p/ajc44j7z
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
mrice@lifesciadvisors.com
(646) 597-6979
VASCULAR BIOGENICS LTD.
CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION
(UNAUDITED)
| March 31, 2019 | December 31, 2018 | |||||||
| U.S. dollars in thousands | ||||||||
| Assets | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 8,255 | $ | 29,347 | ||||
| Short-term bank deposits | 39,407 | 21,135 | ||||||
| Other current assets | 1,325 | 1,227 | ||||||
| TOTAL CURRENT ASSETS | 48,987 | 51,709 | ||||||
| NON-CURRENT ASSETS: | ||||||||
| Property and equipment, net | 8,655 | 8,921 | ||||||
| Right-of-use assets | 2,601 | - | ||||||
| Long-term prepaid expenses | - | 48 | ||||||
| TOTAL NON-CURRENT ASSETS | 11,256 | 8,969 | ||||||
| TOTAL ASSETS | $ | 60,243 | $ | 60,678 | ||||
| Liabilities and equity | ||||||||
| CURRENT LIABILITIES- | ||||||||
| Accounts payable: | ||||||||
| Trade | $ | 1,216 | $ | 1,193 | ||||
| Other | 3,526 | 2,944 | ||||||
| Deferred revenue | 324 | 290 | ||||||
| Lease liabilities | 804 | 347 | ||||||
| TOTAL CURRENT LIABILITIES | 5,870 | 4,774 | ||||||
| NON-CURRENT LIABILITIES- | ||||||||
| Severance pay obligations, net | 102 | 99 | ||||||
| Deferred revenue | 2,128 | 2,263 | ||||||
| Lease liabilities | 2,554 | 449 | ||||||
| TOTAL NON-CURRENT LIABILITIES | 4,784 | 2,811 | ||||||
| TOTAL LIABILITIES | 10,654 | 7,585 | ||||||
| EQUITY: | ||||||||
| Ordinary shares | 73 | 73 | ||||||
| Accumulated other comprehensive income | 41 | 41 | ||||||
| Additional paid in capital | 234,399 | 233,721 | ||||||
| Warrants | 7,904 | 7,904 | ||||||
| Accumulated deficit | (192,828 | ) | (188,646 | ) | ||||
| TOTAL EQUITY | 49,589 | 53,093 | ||||||
| TOTAL LIABILITIES AND EQUITY | $ | 60,243 | $ | 60,678 | ||||
VASCULAR BIOGENICS LTD.
CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(UNAUDITED)
| Three Months Ended March 31, | ||||||||
| 2019 | 2018 | |||||||
| U.S. dollars in thousands | ||||||||
| REVENUES | $ | 219 | $ | 163 | ||||
| COST OF REVENUES | (38 | ) | (67 | ) | ||||
| GROSS PROFIT | 181 | 96 | ||||||
| RESEARCH AND DEVELOPMENT EXPENSES, net | 3,308 | 5,760 | ||||||
| MARKETING EXPENSES | - | 235 | ||||||
| GENERAL AND ADMINISTRATIVE EXPENSES | 1,256 | 1,395 | ||||||
| OPERATING LOSS | 4,383 | 7,294 | ||||||
| FINANCIAL INCOME | (276 | ) | (145 | ) | ||||
| FINANCIAL EXPENSES | 75 | 30 | ||||||
| FINANCIAL INCOME, net | (201 | ) | (115 | ) | ||||
| COMPREHENSIVE LOSS | 4,182 | 7,179 | ||||||
| LOSS PER ORDINARY SHARE | ||||||||
| Basic and diluted | $ | 0.12 | $ | 0.24 | ||||
| Number of shares | ||||||||
| WEIGHTED AVERAGE ORDINARY SHARES OUTSTANDING- | ||||||||
| Basic and diluted | 35,881,128 | 29,887,254 | ||||||
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