VBL Therapeutics Reports Full Year 2021 Financial Results and Provides Corporate Update
OVAL top-line data for ofra-vec progression free survival (PFS) primary endpoint expected in 2H 2022; with positive results, VBL anticipates submitting a Biologics License Application (BLA) in 1H 2023
Completed patient enrollment in the 409 patient OVAL Phase 3 registration enabling trial investigating ofra-vec in patients with platinum-resistant ovarian cancer
Preliminary data from ofra-vec Phase 2 trials in mCRC and rGBM expected in 2022
VB-601, a monoclonal antibody targeting monocytes for prevalent and chronic inflammatory disorders, expected to enter the clinic in 2H 2022
KOL event in NYC to discuss ofra-vec in ovarian cancer planned for April 11, 2022
Conference Call and Webcast at 8:30 a.m. EDT Today
TEL AVIV, Israel and NEW YORK, March 23, 2022 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT) (VBL), a late-clinical stage biotechnology company focused on developing first-in-class therapeutics for difficult-to-treat malignant and solid tumors and immune or inflammatory indications, today announced financial results for the fiscal year ended December 31, 2021, and provided a corporate update.
“2021 was a year of excellent progress for VBL as we advanced our development programs, strengthened our management team and established a direct presence in the United States,” said Dror Harats, M.D., Chief Executive Officer of VBL. “The company is positioned for a potentially transformational year in 2022 as we look forward to the PFS primary endpoint top-line data readout in the Phase 3 OVAL trial in the second half of 2022. We are also expecting preliminary data on ofra-vec from the Phase 2 trials in mCRC and rGBM and plan to enter the clinic in the second half of the year with VB-601, the first candidate from our novel anti-inflammatory program targeting monocytes. We are pleased with the progress and execution at VBL and see multiple opportunities to create value in 2022.”
Fourth Quarter and Recent Corporate Highlights
Development Programs
Enrollment in the Phase 3 OVAL registration-enabling trial in recurrent platinum-resistant ovarian cancer has been completed, with a total of 409 patients enrolled globally.
The Independent Data Safety Monitoring Committee for the OVAL trial conducted a pre-planned safety review of the 370 patients randomized in the trial by December 31, 2021 and unanimously recommended that the trial continue as planned.
Ofra-vec Phase 2 clinical trials in recurrent glioblastoma multiforme (rGBM) and metastatic colorectal cancer (mCRC) continue as planned, with preliminary data expected in 2022.
IND-enabling toxicology studies have been successfully completed for VB-601, a monoclonal antibody targeting monocytes for prevalent and chronic inflammatory disorders, and demonstrated an acceptable toxicology profile to proceed into clinical development. VBL expects to initiate a first-in-human clinical trial for the program in the second half of 2022.
Corporate
Strengthened the management team with the appointment of Matthew Trudeau to the newly created position of Chief Commercial Officer to further advance VBL’s strategic plan to become a commercial organization, and Sam Backenroth as Chief Financial Officer.
Established operations in the United States.
KOL Event on Ovarian Cancer, April 11
VBL plans to host an in-person Key Opinion Leader (KOL) luncheon for the investment community on Monday, April 11, in New York City. The event will feature presentations and a panel discussion with KOLs who will discuss the current treatment landscape and unmet medical need in treating patients with ovarian cancer. For more details and registration to the event refer to: https://ir.vblrx.com/events/event-details/kol-event-ovarian-cancer.
Financial Results for the Full Year 2021
At December 31, 2021, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposits of $53.5 million. VBL expects that its cash, cash equivalents, short-term bank deposits, and restricted bank deposits will be sufficient to fund currently planned operating expenses and capital expenditures for at least twelve months from the date of the readout of top-line PFS data from the Phase 3 OVAL trial.
For the year ended December 31, 2021, VBL reported a net loss of $29.9 million, or ($0.45) per basic share, compared to a net loss of $24.2 million, or ($0.55) per basic share, in the comparable period in 2020.
Revenues for the year ended December 31, 2021, were $0.8 million, as compared to $0.9 million in the comparable period in 2020.
For the year ended December 31, 2021, total operating expenses were approximately $30.4 million, consisting of $22.7 million in research and development expenses, net, and $7.7 million in general and administrative expenses. This compares with total operating expenses of $25.1 million in the year ended December 31, 2020, which was comprised of $19.7 million in research and development expenses, net, and $5.4 million in general and administrative expenses.
Conference Call and Webcast, Wednesday, March 23, 2022 at 8:30am ET
Call Details
Conference ID: | 13727878 |
US: | 1-877-407-9208 |
Israel Local: | 1-809-406-247 |
International: | 1-201-493-6784 |
Webcast: | https://edge.media-server.com/mmc/p/6ntrdxh8 |
The live webcast will be available online and may be accessed from the “Events and Presentations” page of VBL’s 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 Therapeutics
Vascular Biogenics Ltd., operating as VBL Therapeutics, is a late-clinical stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class treatments for difficult-to-treat malignant solid tumors and immune or inflammatory indications. VBL’s novel VTS™ gene-based platform and antibody-based monocyte targeting technology enable the creation of a pipeline of programs that are designed to harness the body’s innate biological processes to provide unique solutions for significant unmet medical needs. VBL’s lead oncology product candidate, ofranergene obadenovec (`ofra-vec`, or VB-111), is an investigational targeted anti-cancer gene-based agent in development to treat a wide range of solid tumors. Ofra-vec is currently being studied in a Phase 3 registration-enabling clinical trial (NCT03398655) for platinum-resistant ovarian cancer. To learn more about VBL, please visit vblrx.com or follow VBL on LinkedIn, Twitter, YouTube or Facebook.
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 timing of topline data from the OVAL trial and its potential to support BLA submission, the therapeutic benefit of ofra-vec (VB-111) and its ability to obtain regulatory approval, among others. 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 the development of pharmaceutical product candidates, including risks associated with conducting 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, and other risks, which risks may be compounded by the ongoing COVID-19 pandemic. A further list and description of these risks, uncertainties and other risks can be found in VBL’s regulatory filings with the U.S. Securities and Exchange Commission, including in its annual report on Form 20-F for the year ended December 31, 2020, 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 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.
CONTACT:
Daniel Ferry
LifeSci Advisors
+1 (617) 430-7576
daniel@lifesciadvisors.com
VASCULAR BIOGENICS LTD.
CONSOLIDATED BALANCE SHEETS
December 31 | |||||||
2021 | 2020 | ||||||
U.S. dollars in thousands | |||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 21,986 | $ | 13,184 | |||
Restricted bank deposits | - | 151 | |||||
Short-term bank deposits | 31,164 | 17,110 | |||||
Trade receivables | - | 129 | |||||
Other current assets | 1,697 | 1,419 | |||||
Total current assets | 54,847 | 31,993 | |||||
Non-current assets: | |||||||
Restricted bank deposits | $ | 362 | $ | 362 | |||
Long-term prepaid expenses | 182 | 241 | |||||
Funds in respect of employee rights upon retirement | 415 | 354 | |||||
Property, plant and equipment, net | 6,847 | 6,632 | |||||
Operating lease right-of-use assets | 2,008 | 2,124 | |||||
Total non-current assets | 9,814 | 9,713 | |||||
Total assets | $ | 64,661 | $ | 41,706 | |||
LIABILITIES AND SHAREHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable: | |||||||
Trade | $ | 4,331 | $ | 1,960 | |||
Other | 4,408 | 4,275 | |||||
Deferred revenue | 658 | 725 | |||||
Current maturity of operating leases | 529 | 393 | |||||
Current maturity of finance lease liability | - | 106 | |||||
Total current liabilities | $ | 9,926 | $ | 7,459 | |||
Non-current liabilities: | |||||||
Liability for employee rights upon retirement | 546 | 474 | |||||
Deferred revenue | - | 704 | |||||
Operating lease liability | 1,823 | 2,029 | |||||
Other non-current liability | 188 | 123 | |||||
Total non-current liabilities | 2,557 | 3,330 | |||||
Commitments (Note 8) | |||||||
Total liabilities | $ | 12,483 | $ | 10,789 | |||
Ordinary shares subject to possible redemption, 615,366 shares at redemption value (Note 9) | 1,598 | - | |||||
Shareholders’ equity: | |||||||
Ordinary shares, NIS 0.01 par value; Authorized as of December 31, 2021 and 2020, 150,000,000 and 70,000,000 shares, respectively; issued and outstanding as of December 31, 2021 and 2020, 68,711,584 and 48,187,463 shares, respectively (excluding 615,366 and -0- shares subject to possible redemption, as of December 31, 2021 and December 31, 2020, respectively) | 171 | 108 | |||||
Additional paid in capital | 309,355 | 252,561 | |||||
Warrants | 3,127 | 10,401 | |||||
Accumulated deficit | (262,073 | ) | (232,153 | ) | |||
Total equity | 50,580 | 30,917 | |||||
Total liabilities and equity | $ | 64,661 | $ | 41,706 | |||
VASCULAR BIOGENICS LTD.
CONSOLIDATED STATEMENTS OF NET LOSS AND COMPREHENSIVE LOSS
(U.S. dollars in thousands, except share and per share amounts)
Year ended December 31 | |||||||||||
2021 | 2020 | 2019 | |||||||||
U.S. dollars in thousands | |||||||||||
Revenues | $ | 768 | $ | 922 | $ | 562 | |||||
Cost of revenues | (365 | ) | (394 | ) | (222 | ) | |||||
Gross profit | 403 | 528 | 340 | ||||||||
Research and development expenses, net | 22,695 | 19,656 | 14,714 | ||||||||
General and administrative expenses | 7,704 | 5,355 | 5,708 | ||||||||
Operating loss | 29,996 | 24,483 | 20,082 | ||||||||
Financial income | (120 | ) | (363 | ) | (870 | ) | |||||
Financial expenses | 44 | 105 | 184 | ||||||||
Financial income, net | (76 | ) | (258 | ) | (686 | ) | |||||
Net loss and comprehensive loss | $ | 29,920 | $ | 24,225 | $ | 19,396 | |||||
U.S. dollars | |||||||||||
Loss per ordinary share | |||||||||||
Basic and diluted | $ | 0.45 | $ | 0.55 | $ | 0.54 | |||||
Number of shares | |||||||||||
Weighted average ordinary shares outstanding | |||||||||||
Basic and diluted | 66,346,506 | 43,668,155 | 35,881,256 | ||||||||
