- Continued progress in OVAL Phase 3 potential-registration study in patients with platinum-resistant ovarian cancer; high response rates (RR) of over 50% in the total evaluable patient population with approximately 200 patients enrolled to date
- Management to host conference call and webcast at 8:30 am Eastern Time Today
TEL AVIV, Israel, Nov. 16, 2020 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT), today reported its financial results for the third quarter ended September 30, 2020, and provided a corporate update.
“The clinical development program for VB-111, our unique gene therapy for solid tumors, continues to advance well. Patient enrollment in the OVAL Phase 3 study in ovarian cancer continues to be ahead of plan, with almost 200 patients enrolled to date. We had two positive DSMC analyses, indicating that our OVAL trial remains on the right track,” said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. “While it is important to note that the study remains blinded, we are encouraged by the very high response rate (RR), over 50%, that we continue to see to date. This RR is impressively higher than expected for standard-of-care treatments, for which RR is typically in the teens. If successful, the OVAL trial has the potential to establish VB-111 as a new standard of care in a challenging disease setting where patients currently have limited options.”
Third Quarter and Recent Key Corporate Highlights:
VB-111
| ● | Provided an update on the ongoing OVAL Phase 3 study investigating VB-111 in patients with platinum-resistant ovarian cancer | |
| ○ | High response rate of over 50% continues to be observed in the total evaluable patient population (treatment and control groups combined) to date, consistent with results from interim analysis reported in March | |
| ○ | Approximately 50% of study participants enrolled to date. | |
| ● | Initiated an investigator sponsored Phase 2 study of VB-111 in combination with nivolumab (Opdivo®), an immune checkpoint inhibitor, for patients with metastatic colorectal cancer. | |
| ○ | Study is being conducted under a Cooperative Research and Development Agreement (CRADA) between the National Cancer Institute (NCI) and VBL. | |
| ● | Investigator sponsored VB-111 Phase 2 studies, in rGBM, at Dana Farber Cancer Center and other leading neuro-oncology centers is also on track for initiation. | |
MOSPD2
| ● | Held a pre-IND meeting with the FDA, reaching alignment on the clinical development of lead candidate VB-601 for immune-inflammatory indications; on track to submit an IND for a first-in-human study in the second half of 2021. |
| ● | Anti-MOSPD2 mAbs significantly inhibited migration of monocytes isolated from all MS patients included in the study (n=33) by up to 97%, regardless of disease severity, gender or active treatment. |
| ● | Two patents granted by the European Patent Office (EPO) for anti-MOSPD2 platform technology to treat cancer and inflammatory conditions, including relapsing-remitting and progressive MS, rheumatoid arthritis, NASH and inflammatory bowel disease. |
Corporate:
| ● | In October 2020, Marc Kozin was appointed as Vice Chairman of the Board of Directors. Mr. Kozin will transition to the Chairman role during 2021. |
Third Quarter 2020 Financial Results
Cash Position. As of September 30, 2020, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposit totaling $37.3 million and working capital of $30.8 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 into the third quarter of 2022.
Revenue: Revenues for the third quarter, 2020 were $193 thousand, compared to $79 thousand for the comparable period in 2019.
Research and Development (R&D) Expenses: R&D expenses were $4.8 million for the three months ended September 30, 2020, compared to $3.8 million for the three months ended September 30, 2019.
General and Administrative (G&A) Expenses: G&A expenses were $1.1 million for the three months ended September 30, 2020, compared to $1.2 million for the three months ended September 30, 2019.
Comprehensive Loss: VBL reported a net loss of $5.8 million for the three months ended September 30, 2020, compared to a net loss of $4.9 million for the three months ended September 30, 2019.
For further details on VBL’s financials, please refer to Form 6-k filed with the SEC.
Conference Call:
Monday, November 16 @ 8:30 a.m. ET.
As previously announced, VBL will host a webcast Monday, November 16, 2020, at 8:30 a.m. ET.
| From the US: | 877-407-9208 |
| International: | 201-493-6784 |
| Israel local Number: | 1 809 406 247 |
| Conference ID: | 13711944 |
| Webcast: | https://edge.media-server.com/mmc/p/5wkkzaat |
The live webcast will be available online and may be accessed from the “Events and Presentation” page of the company website. A replay of the webcast will be available beginning approximately one hour after the conclusion of the call and will remain available for at least 30 days thereafter.
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 areas of unmet need in cancer and immune/inflammatory indications. VBL has developed three platform technologies: a gene-therapy based technology for targeting newly formed blood vessels with focus on cancer, an antibody-based technology targeting MOSPD2 for anti-inflammatory and immuno-oncology applications, and the Lecinoxoids, a family of small-molecules for immune-related 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 6-8 weeks. It has been observed to be well-tolerated in >300 cancer patients and demonstrated activity signals in a VBL-sponsored “all comers” Phase 1 trial as well as in three VBL-sponsored tumor-specific Phase 2 studies. Ofranergene obadenovec is currently being studied in a VBL-sponsored 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, 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, the impact of the COVID-19 pandemic on our business, operations, clinical trials, supply chain, strategy, goals and anticipated timelines and clinical 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, 2019, 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:
Irina Koffler
LifeSci Advisors
ikoffler@lifesciadvisors.com
(646) 970-4681
VASCULAR BIOGENICS LTD.
CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION
(UNAUDITED)
| September 30, 2020 | December 31, 2019 | |||||||
| U.S. dollars in thousands | ||||||||
| Assets | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 11,633 | $ | 9,436 | ||||
| Short-term bank deposits | 25,169 | 27,100 | ||||||
| Short-term restricted bank deposits | 153 | - | ||||||
| Trade Receivables | 123 | - | ||||||
| Other current assets | 1,105 | 1,242 | ||||||
| TOTAL CURRENT ASSETS | 38,183 | 37,778 | ||||||
| NON-CURRENT ASSETS: | ||||||||
| Restricted bank deposits | 358 | 506 | ||||||
| Property and equipment, net | 6,228 | 6,949 | ||||||
| Right-of-use assets | 2,846 | 3,088 | ||||||
| Long-term prepaid expenses | 257 | 300 | ||||||
| TOTAL NON-CURRENT ASSETS | 9,689 | 10,843 | ||||||
| TOTAL ASSETS | $ | 47,872 | $ | 48,621 | ||||
| Liabilities and equity | ||||||||
| CURRENT LIABILITIES- | ||||||||
| Accounts payable and accruals: | ||||||||
| Trade | $ | 3,148 | $ | 3,330 | ||||
| Other | 3,096 | 4,238 | ||||||
| Deferred revenue | 583 | 386 | ||||||
| Lease liabilities | 579 | 774 | ||||||
| TOTAL CURRENT LIABILITIES | 7,406 | 8,728 | ||||||
| NON-CURRENT LIABILITIES- | ||||||||
| Severance pay obligations, net | 164 | 163 | ||||||
| Deferred revenue | 1,046 | 1,723 | ||||||
| Other non-current liability | 99 | - | ||||||
| Lease liabilities | 1,985 | 2,167 | ||||||
| TOTAL NON-CURRENT LIABILITIES | 3,294 | 4,053 | ||||||
| TOTAL LIABILITIES | 10,700 | 12,781 | ||||||
| SHAREHOLDERS’ EQUITY: | ||||||||
| Ordinary shares, NIS 0.01 par value; Authorized as of September 30, 2020 and December 31, 2019, 150,000,000 and 70,000,000 shares, respectively; issued and outstanding as of September 30, 2020 and December 31, 2019, 47,896,936 and 35,882,928 shares, respectively | 108 | 73 | ||||||
| Accumulated other comprehensive income | (8 | ) | (8 | ) | ||||
| Additional paid in capital | 251,742 | 235,974 | ||||||
| Warrants | 10,401 | 7,904 | ||||||
| Accumulated deficit | (225,071 | ) | (208,103 | ) | ||||
| TOTAL SHAREHOLDERS’ EQUITY | 37,172 | 35,840 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ | 47,872 | $ | 48,621 | ||||
VASCULAR BIOGENICS LTD.
CONDENSED INTERIM STATEMENTS OF NET LOSS AND COMPREHENSIVE LOSS
(UNAUDITED)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| U.S. dollars in thousands | ||||||||||||||||
| Revenues | $ | 193 | $ | 79 | $ | 717 | $ | 436 | ||||||||
| Cost of revenues | (75 | ) | (30 | ) | (188 | ) | (118 | ) | ||||||||
| Gross profit | 118 | 49 | 529 | 318 | ||||||||||||
| Research and development expenses, net | $ | 4,805 | $ | 3,795 | $ | 14,421 | $ | 10,832 | ||||||||
| General and administrative expenses | 1,106 | 1,232 | 3,348 | 3,669 | ||||||||||||
| Operating loss | 5,793 | 4,978 | 17,240 | 14,183 | ||||||||||||
| Financial income | (53 | ) | (223 | ) | (382 | ) | (722 | ) | ||||||||
| Financial expenses | 37 | 101 | 110 | 267 | ||||||||||||
| Financial income, net | (16 | ) | (122 | ) | (272 | ) | (455 | ) | ||||||||
| Net loss and comprehensive loss | $ | 5,777 | $ | 4,856 | $ | 16,968 | $ | 13,728 | ||||||||
| Loss per ordinary share | U.S. dollars | |||||||||||||||
| Basic and diluted | $ | 0.12 | $ | 0.14 | $ | 0.40 | $ | 0.38 | ||||||||
| Number of shares | ||||||||||||||||
| Weighted average ordinary shares outstanding | ||||||||||||||||
| Basic and diluted | 47,896,747 | 35,881,128 | 42,222,603 | 35,881,128 | ||||||||||||