VBL Therapeutics announced financial results for the second quarter ended June 30, 2021, and provided a corporate update.
Conference Call and Webcast at 8:30 a.m. EDT Today
- Closed public offering raising net proceeds of $26.4 million; cash position is expected to fund operations until year-end 2023, through readout from the OVAL study and potential Biologics License Application (BLA) submission for VB-111 in ovarian cancer
- Announced amendment to primary endpoint in OVAL study to include progression free survival (PFS); PFS data expected in second half of 2022; next Data and Safety Monitoring Committee (DSMC) review expected 3Q21
- Prepared and submitted requested VB-111 Chemistry, Manufacturing, and Controls (CMC) documentation to the FDA in early August; currently awaiting FDA guidance on use of new batches
TEL AVIV, Israel, Aug. 16, 2021 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT) today announced financial results for the second quarter ended June 30, 2021, and provided a corporate update.
“With $57.2 million in cash that is projected to fund our operations until year-end 2023, we are excited to advance our OVAL study, with PFS as its additional primary endpoint, towards clinical readout in the second half of 2022,” said Dror Harats, M.D., Chief Executive Officer of VBL. “Following the FDA request for additional technical production data on VB-111, we prepared and submitted the requested information in early August and are currently awaiting agency guidance. With several important milestones anticipated through the rest of 2021, we look forward to keeping investors apprised of our progress.”
Second Quarter and Recent Corporate Highlights
| ● | In June, VBL presented an update on the progress of the OVAL Phase 3 registration-enabling study of VB-111 in ovarian cancer at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. The presentation announced an amendment to the primary endpoint in the OVAL study to include a second, separate primary endpoint of PFS in addition to the original primary endpoint of overall survival (OS). | |
| ● | As part of VBL’s discussion with the Chemistry, Manufacturing, and Controls (CMC) group of the FDA on VB-111 production, it was agreed that VBL would provide additional documentation on new batches to be used in the OVAL study. VBL prepared and submitted the requested documentation to the FDA in early August and is currently awaiting agency guidance. | |
| ● | As a precautionary step to preserve supply of FDA-approved batches, in June, VBL voluntarily paused enrollment of new U.S. patients in the OVAL study. Existing patients enrolled in the United States continue on protocol and enrollment continues in Europe, Israel, and in recently opened sites in Japan. |
Corporate
| ● | In April, VBL closed a public offering raising net proceeds of $26.4 million. The Company’s cash position is expected to fund operations until year-end 2023, through the readout from the OVAL study and potential BLA submission for VB-111 in ovarian cancer. | |
| ● | In July, VBL announced the appointments of Alison Finger and Michael Rice to its Board of Directors. | |
| ● | In July, the planned succession for Chairmanship of VBL’s Board of Directors was completed. Marc Kozin, who joined the Board as Vice Chairman in October 2020 was appointed Chairman. Former Chairman, Dr. Bennett Shapiro, stepped down as Chairman but will remain a Director. |
Financial Results for the Second Quarter 2021
| ● | As of June 30, 2021, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposits totaling $57.2 million. In April 2021, VBL raised net proceeds of $26.4 million in a public offering of shares and pre-funded warrants (including partial exercise of the underwriters’ overallotment option). VBL expects that its cash, cash equivalents and short-term bank deposits will be sufficient to fund operating expenses and capital expenditure requirements until year-end 2023. | |
| ● | Revenues for the second quarter 2021 were $188 thousand, as compared to $158 thousand in the comparable period in 2020. | |
| ● | R&D expenses, net, were $6.6 million for the second quarter compared to $4.7 million in the comparable period in 2020. This increase is due to the clinical development activity of VB-111 for ovarian cancer, in addition to the advancement of VB-601 toward Investigational New Drug Application (IND) submission. | |
| ● | G&A expenses were $1.5 million for the second quarter compared to $1.3 million in the comparable period in 2020. | |
| ● | VBL reported a net loss for the quarter ended June 30, 2021, of $8.0 million, or ($0.12) per basic share, compared to a net loss of $5.8 million, or ($0.14) per basic share, in the comparable period in 2020. |
Conference Call and Webcast:
Monday, August 16 at 8:30 a.m. EDT
Conference ID: 13721456
From the US: 1 877 407 9208
Israel Local: 1 809 406 247
International: 1 201 493 6784
Webcast: https://edge.media-server.com/mmc/p/9trg9snq
The live webcast will be available online and may be accessed from the “Events and Presentation” 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.
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; `ofra-vec`), is an investigational, first-in-class, targeted anti-cancer gene-therapy agent that is being developed to treat a wide range of solid tumors. VB-111 is currently being studied in a VBL-sponsored Phase 3 registration enabling 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 may include, but are not limited to, statements regarding our programs, including VB-111, including their clinical development, therapeutic potential and clinical results. 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. In particular, the DSMC recommendation that the OVAL trial proceed is not assurance that the trial will meet its primary endpoint of overall survival once completed, or that we will obtain positive results to support further development of this candidate. 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, 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 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.
| CONTACT: | |
| Burns McClellan for VBL Therapeutics | |
| Lee Roth & Eric Ando (Investors) | |
| LRoth@burnsmc.com & EAndo@burnsmc.com | |
| +1-212-213-0006 | |
| Robert Flamm & Harrison Wong (Media) | |
| RFlamm@burnsmc.com & HWong@burnsmc.com | |
| +1-212-213-0006 |
VASCULAR BIOGENICS LTD.
CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION
(UNAUDITED)
| June 30, 2021 | December 31, 2020 | |||||||
| U.S. dollars in thousands | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 31,660 | $ | 13,184 | ||||
| Restricted bank deposits | - | 151 | ||||||
| Short-term bank deposits | 25,131 | 17,110 | ||||||
| Trade receivables | - | 129 | ||||||
| Other current assets | 1,017 | 1,419 | ||||||
| Total current assets | 57,808 | 31,993 | ||||||
| Non-current assets: | ||||||||
| Restricted bank deposits | 361 | 362 | ||||||
| Long-term prepaid expenses | 222 | 241 | ||||||
| Funds in respect of employee rights upon retirement | 337 | 354 | ||||||
| Property, plant and equipment, net | 6,439 | 6,632 | ||||||
| Operating lease right-of-use assets | 2,173 | 2,124 | ||||||
| Total non-current assets | 9,532 | 9,713 | ||||||
| Total assets | $ | 67,340 | $ | 41,706 | ||||
| LIABILITIES, ORDINARY SHARES SUBJECT TO POSSIBLE REDEMPTION AND | ||||||||
| SHAREHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable: | ||||||||
| Trade | $ | 2,487 | $ | 1,960 | ||||
| Other | 4,864 | 4,275 | ||||||
| Deferred revenue | 752 | 725 | ||||||
| Current maturity of operating leases liability | 477 | 393 | ||||||
| Current maturity of finance lease liability | - | 106 | ||||||
| Total current liabilities | $ | 8,580 | $ | 7,459 | ||||
| Non-current liabilities: | ||||||||
| Liability for employee rights upon retirement | 452 | 474 | ||||||
| Deferred revenue | 352 | 704 | ||||||
| Operating lease liability | 1,946 | 2,029 | ||||||
| Other non-current liability | 155 | 123 | ||||||
| Total non-current liabilities | 2,905 | 3,330 | ||||||
| Commitments | ||||||||
| Total liabilities | $ | 11,485 | $ | 10,789 | ||||
| Ordinary shares subject to possible redemption, 615,366 shares at redemption value (see note 4b) | 1,598 | - | ||||||
| Shareholders’ equity: | ||||||||
| Ordinary shares, NIS 0.01 par value; Authorized as of June 30, 2021 and December 31, 2020, 150,000,000 shares; issued and outstanding as of June 30, 2021 and December 31, 2020 61,421,159 and 48,187,463 shares, respectively (excluding 615,366 and -0- shares subject to possible redemption, as of June 30, 2021 and December 31, 2020, respectively) | 148 | 108 | ||||||
| Additional paid in capital | 292,017 | 252,561 | ||||||
| Warrants | 8,556 | 10,401 | ||||||
| Accumulated deficit | (246,464 | ) | (232,153 | ) | ||||
| Total equity | 54,257 | 30,917 | ||||||
| Total liabilities, ordinary shares subject to possible redemption and shareholders’ equity | $ | 67,340 | $ | 41,706 | ||||
The accompanying notes are an integral part of the financial statements.
VASCULAR BIOGENICS LTD.
CONDENSED INTERIM STATEMENTS OF NET LOSS AND COMPREHENSIVE LOSS
(UNAUDITED)
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| U.S. dollars in thousands | ||||||||||||||||
| Revenues | $ | 188 | $ | 158 | $ | 373 | $ | 524 | ||||||||
| Cost of revenues | (89 | ) | (21 | ) | (179 | ) | (166 | ) | ||||||||
| Gross profit | 99 | 137 | 194 | 358 | ||||||||||||
| Research and development expenses, net | $ | 6,642 | $ | 4,664 | $ | 11,411 | $ | 9,173 | ||||||||
| General and administrative expenses | 1,481 | 1,338 | 3,154 | 2,677 | ||||||||||||
| Operating loss | 8,024 | 5,865 | 14,371 | 11,492 | ||||||||||||
| Financial income | (3 | ) | (45 | ) | (87 | ) | (335 | ) | ||||||||
| Financial expenses | 7 | 11 | 27 | 26 | ||||||||||||
| Financial income, net | 4 | (34 | ) | (60 | ) | (309 | ) | |||||||||
| Net loss and comprehensive loss | $ | 8,028 | $ | 5,831 | $ | 14,311 | $ | 11,183 | ||||||||
| U.S. dollars | ||||||||||||||||
| Loss per share (see note 3) | ||||||||||||||||
| Basic and diluted | $ | 0.12 | $ | 0.14 | $ | 0.24 | $ | 0.28 | ||||||||
| Number of shares | ||||||||||||||||
| Weighted average shares outstanding | ||||||||||||||||
| Basic and diluted | 68,092,953 | 42,674,526 | 60,075,863 | 39,354,355 | ||||||||||||
The accompanying notes are an integral part of the financial statements.
