VBL Therapeutics Reports Third Quarter 2020 Financial Results and Provides Corporate Update
VBL Therapeutics (Nasdaq: VBLT) announced progress in its OVAL Phase 3 study of VB-111 for platinum-resistant ovarian cancer, reporting a response rate of over 50% among approximately 200 enrolled patients. The company’s financial results for Q3 2020 show revenues of $193,000, up from $79,000 in Q3 2019, with a net loss of $5.8 million compared to $4.9 million the previous year. The cash position is strong, with $37.3 million on hand, expected to sustain operations through Q3 2022. VBL also initiated a Phase 2 study for VB-111 in colorectal cancer and reached alignment with the FDA for VB-601's clinical development.
- Response rate of over 50% in OVAL Phase 3 study for VB-111.
- Revenue increased to $193,000 in Q3 2020, up from $79,000 in 2019.
- Strong cash position of $37.3 million expected to fund operations into Q3 2022.
- Initiated new Phase 2 study of VB-111 in combination with nivolumab.
- Net loss of $5.8 million in Q3 2020, increasing from $4.9 million in Q3 2019.
- R&D expenses rose to $4.8 million for Q3 2020, up from $3.8 million the previous year.
- Continued progress in OVAL Phase 3 potential-registration study in patients with platinum-resistant ovarian cancer; high response rates (RR) of over
- 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
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 | |
○ | Approximately | |
● | 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 |
● | 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
Revenue: Revenues for the third quarter, 2020 were
Research and Development (R&D) Expenses: R&D expenses were
General and Administrative (G&A) Expenses: G&A expenses were
Comprehensive Loss: VBL reported a net loss of
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 |
FAQ
What are the latest developments for VBL Therapeutics' VB-111 as of November 2020?
How did VBL Therapeutics perform financially in Q3 2020?
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