OVAL Phase 3 registration-enabling study investigating VB-111 in patients with platinum-resistant ovarian cancer remains on track in spite of COVID-19, with over 260 patients enrolled; next DSMC review expected 3Q21
Conference Call and Webcast at 8:30 a.m. EDT Today
- OVAL Phase 3 registration-enabling study investigating VB-111 in patients with platinum-resistant ovarian cancer remains on track in spite of COVID-19, with over 260 patients enrolled; next DSMC review expected 3Q21
- Closed public offering, raising gross proceeds of $28.3 million
- Additional $12.3 million raised during the first quarter, primarily through exercise of outstanding warrants
- Cash position expected to fund operations until year-end 2023, through OVAL study readout and potential BLA filing
- Company to present update on OVAL at the ASCO conference
TEL AVIV, Israel, May 11, 2021 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT) today announced financial results for the first quarter ended March 31, 2021 and provided a corporate update.
“Our OVAL Phase 3 clinical trial remains on track and passed its most recent safety review, with the next one coming in the third quarter,” said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. “During the first quarter and in early April, we strengthened our balance sheet, raising a total of approximately $40 million in additional capital, $12.3 million primarily through the exercise of outstanding warrants and gross proceeds of $28.3 million through a public financing. The additional capital extends our cash runway until year-end 2023. We have a number of important milestones anticipated through the rest of 2021 and look forward to keeping investors apprised of our progress.”
First Quarter and Recent Corporate Highlights
- In February, a successful pre-planned DSMC review of the OVAL study found no safety issues with the trial and recommended its continuation as planned.
- In March, the Company announced the initiation of randomized, controlled and blinded trial of VB-111 in patients with recurrent Glioblastoma Multiforme (rGBM).
- In March, the Company announced the publication of positive results in peer-reviewed journal Gynecologic Oncology of the pre-specified interim analysis of the OVAL Phase 3 Registration Enabling Study of VB-111 in Ovarian Cancer. The analysis showed a CA-125 response of at least 58% in the VB-111 treatment arm.
- Development of VB-111 in rGBM and colorectal cancer, as well as of pipeline assets, continues as planned.
Corporate
- In January, the Company entered into an ordinary share purchase agreement of up to $20 million with Aspire Capital Fund LLC
- During the first quarter, the Company raised an additional $12.3 million through a combination of sales under the Aspire share purchase agreement, sales through its At-the-Market (ATM) facility and the exercise of outstanding warrants
- In April, the Company closed a public offering raising gross proceeds of $28.3 million
Financial Results for the First Quarter 2021
- As of March 31, 2021, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposits totaling $36.6 million. After the end of the first quarter, VBL raised gross proceeds of $28.3 million in a public offering of shares and pre-funded warrants. VBL expects that its cash and 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 first quarter 2021 were $185 thousand, as compared to $366 thousand in the comparable period in 2020.
- R&D expenses, net were $4.8 million for the first quarter compared to $4.5 million in the comparable period in 2020.
- G&A expenses were $1.7 million for the fiscal year, compared to $1.3 million in the comparable period in 2020.
- VBL reported a net loss for the quarter ended March 31, 2021, of $6.3 million, or ($0.12) per basic share, compared to a net loss of $5.4 million, or ($0.15) per basic share, in the comparable period in 2020.
Conference Call:
Tuesday, May 11 at 8:30 a.m. EDT
Conference ID: 13719410
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/w794ban7
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 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 (investors) / Ryo Imai (media)
lroth@burnsmc.com / rimai@burnsmc.com
+1-212-213-0006
VASCULAR BIOGENICS LTD.
CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION
(UNAUDITED)
| March 31, 2021 | December 31, 2020 | |||||||
| U.S. dollars in thousands | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 24,231 | $ | 13,184 | ||||
| Restricted bank deposits | - | 151 | ||||||
| Short-term bank deposits | 12,021 | 17,110 | ||||||
| Trade receivables | - | 129 | ||||||
| Other current assets | 1,156 | 1,419 | ||||||
| Total current assets | 37,408 | 31,993 | ||||||
| Non-current assets: | ||||||||
| Restricted bank deposits | 361 | 362 | ||||||
| Long-term prepaid expenses | 219 | 241 | ||||||
| Funds in respect of employee rights upon retirement | 330 | 354 | ||||||
| Property, plant and equipment, net | 6,547 | 6,632 | ||||||
| Operating lease right-of-use assets | 2,212 | 2,124 | ||||||
| Total non-current assets | 9,669 | 9,713 | ||||||
| Total assets | $ | 47,077 | $ | 41,706 | ||||
| LIABILITIES, ORDINARY SHARES SUBJECT TO POSSIBLE REDEMPTION AND SHAREHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable: | ||||||||
| Trade | $ | 1,600 | $ | 1,960 | ||||
| Other | 3,987 | 4,275 | ||||||
| Deferred revenue | 713 | 725 | ||||||
| Current maturity of operating leases liability | 438 | 393 | ||||||
| Current maturity of finance lease liability | - | 106 | ||||||
| Total current liabilities | $ | 6,738 | $ | 7,459 | ||||
| Non-current liabilities: | ||||||||
| Liability for employee rights upon retirement | 442 | 474 | ||||||
| Deferred revenue | 528 | 704 | ||||||
| Operating lease liability | 1,974 | 2,029 | ||||||
| Other non-current liability | 143 | 123 | ||||||
| Total non-current liabilities | 3,087 | 3,330 | ||||||
| Commitments | ||||||||
| Total liabilities | $ | 9,825 | $ | 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 March 31, 2021 and December 31, 2020, 150,000,000 shares; issued and outstanding as of March 31, 2021 and December 31, 2020 54,519,369 and 48,187,463 shares, respectively (excluding 615,366 and -0- shares subject to possible redemption, as of March 31, 2021 and December 31, 2020, respectively) | 127 | 108 | ||||||
| Additional paid in capital | 265,407 | 252,561 | ||||||
| Warrants | 8,556 | 10,401 | ||||||
| Accumulated deficit | (238,436 | ) | (232,153 | ) | ||||
| Total equity | 35,654 | 30,917 | ||||||
| Total liabilities, ordinary shares subject to possible redemption and shareholders’ equity | $ | 47,077 | $ | 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 March 31 | ||||||||
| 2021 | 2020 | |||||||
| U.S. dollars in thousands | ||||||||
| Revenues | $ | 185 | $ | 366 | ||||
| Cost of revenues | (90 | ) | (145 | ) | ||||
| Gross profit | 95 | 221 | ||||||
| Research and development expenses, net | 4,769 | 4,509 | ||||||
| General and administrative expenses | 1,673 | 1,339 | ||||||
| Operating loss | 6,347 | 5,627 | ||||||
| Financial income | (84 | ) | (290 | ) | ||||
| Interest expense | 20 | 15 | ||||||
| Financial (income), net | (64 | ) | (275 | ) | ||||
| Net loss and comprehensive loss | $ | 6,283 | $ | 5,352 | ||||
| Loss per share (see note 3) | ||||||||
| Basic and diluted | $ | 0.12 | $ | 0.15 | ||||
| Weighted average shares outstanding | ||||||||
| Basic and diluted | 52,113,675 | 36,103,500 | ||||||
The accompanying notes are an integral part of the financial statements.
