NOTABLE LABS, LTD. OVAL Phase 3 top-line data expected in 2H 2022; with positive results, VBL anticipates submitting a BLA to the FDA in 1H 2023
Conference Call and Webcast at
“We continue to execute on our development and strategic objectives, which we believe have positioned us for a potentially transformational year,” said Dror Harats, M.D., Chief Executive Officer of VBL. “Completion of enrollment in the Phase 3 OVAL trial in recurrent platinum-resistant ovarian cancer in the first quarter of 2022 was a major milestone, and we look forward to the progression free survival primary endpoint top-line data readout expected in the second half of 2022. We are also expecting preliminary clinical data from the ofra-vec Phase 2 trials in metastatic colorectal cancer and recurrent glioblastoma multiforme in 2022. In parallel with these oncology programs, we are advancing our pipeline and plan to enter the clinic in the second half of the year with VB-601, the first product candidate from our novel anti-inflammatory program targeting monocytes.”
First Quarter of 2022 and Recent Corporate Highlights
Ofra-vec Oncology Program
- Completed enrollment in the Phase 3 OVAL registration-enabling trial evaluating ofra-vec (ofranergene obadenovec; `VB-111`) in recurrent platinum-resistant ovarian cancer, with a total of 409 patients enrolled globally.
- The
U.S. Food and Drug Administration (FDA) granted fast track designation for ofra-vec in combination with paclitaxel for the treatment of platinum-resistant ovarian cancer. - The Independent Data Safety Monitoring Committee (iDSMC) conducted a pre-planned safety review of the 370 patients randomized in the OVAL trial by
December 31, 2021 , and unanimously recommended that the trial continue as planned. - VBL hosted a key opinion leader (KOL) event on ovarian cancer in
New York City , NY onApril 11 featuring KOLs Bradley J. Monk, M.D., FACS, FACOG (University of Arizona College of Medicine ;Creighton University School of Medicine ),Richard Penson , M.D., MRCP (Massachusetts General Hospital ) andKathleen Moore , M.D. (University of Oklahoma College of Medicine ). A replay of the event is archived here. - Ofra-vec Phase 2 clinical trials in recurrent glioblastoma multiforme (rGBM) and metastatic colorectal cancer (mCRC) continue as planned, with preliminary data from both trials expected in 2022.
VB-601 Inflammation Program
- Presented for the first time molecular mechanistic data on the Monocyte Targeting Technology (MTT) and lead candidate VB-601 at the IMMUNOLOGY 2022 conference in
Portland, OR onMay 8, 2022 . Data explained how VB-601 inhibited the migration of monocytes into inflamed tissues, providing a novel and differentiated approach with potential applications in various chronic inflammatory indications. - Prof. Dror Harats delivered a presentation on VB-601 at the LifeSci Partners Immunology & Inflammation Symposium on
May 12, 2022 . The presentation is archived here. - IND-enabling toxicology studies have been successfully completed for VB-601 and VBL expects to initiate a first-in-human clinical trial for the program in the second half of 2022.
Presentations at 2022 ASCO Annual Meeting
- Two abstracts highlighting ofra-vec clinical research have been selected for presentation at the upcoming
American Society of Clinical Oncology (ASCO) 2022 Annual Meeting taking placeJune 3-7, 2022 . These Trial in Progress posters will highlight the Phase 3 OVAL trial of ofra-vec in platinum-resistant ovarian cancer and the Phase 2 trial in surgically accessible rGBM.
Corporate
- Strengthened the management team with the appointment of
Matthew Trudeau to the newly created position of Chief Commercial Officer and initiated the build out ofU.S. operations to further advance VBL’s strategic plan to become a commercial organization.
Financial Results for the First Quarter of 2022
- At
March 31, 2022 , VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposits of$44.8 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 a year beyond the Phase 3 OVAL trial top-line progression free survival (PFS) results. - For the quarter ended
March 31, 2022 , VBL reported a net loss of$10.4 million , or ($0.13 ) per basic share, compared to a net loss of 6.3 million, or ($0.12 ) per basic share, in the comparable period in 2021. - For the quarter ended
March 31, 2022 , total operating expenses were approximately$10.7 million , consisting of$7.5 million in research and development expenses, net, and$3.2 million in general and administrative expenses. This compares with total operating expenses of$6.5 million in the first quarter endedMarch 31, 2021 , which was comprised of$4.8 million in research and development expenses, net, and$1.7 million in general and administrative expenses.
| Conference Call and Webcast: | ||
| Tuesday, May 17 at 8:30 a.m. ET | ||
| Conference ID: 13729281 | ||
| Israel Local: 1 809 406 247 | ||
| International: 1-201-493-6784 | ||
| Webcast: https://edge.media-server.com/mmc/p/8pjhkd83 | ||
About the OVAL Phase 3 Clinical Trial
OVAL (VB-111-701/GOG-3018) is an international Phase 3 randomized, pivotal registration-enabling clinical trial comparing a combination of ofra-vec (ofranergene obadenovec; `VB-111`) and paclitaxel to placebo plus paclitaxel, in adult patients with recurrent platinum-resistant ovarian cancer. The OVAL trial has two primary endpoints: progression free survival (PFS) and overall survival (OS). Successfully meeting either primary endpoint has the potential to support a Biologics License Application (BLA). Meeting the PFS endpoint, with a top-line readout anticipated in the second half of 2022, could accelerate BLA submission by approximately one year, subject to discussions with the
About
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 the timing of data readouts for multiple ofra-vec clinical trials, including in recurrent platinum-resistant ovarian cancer, rGBM and mCRC; timing of submission of a BLA for ofra-vec to the FDA; timing of the initiation of a first-in-human trial for VB-601; statements regarding 2022 being a transformational year; buildout of a presence in
CONTACT:
+1 (617) 430-7576
daniel@lifesciadvisors.com
STATEMENTS OF FINANCIAL POSITION (UNAUDITED) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 13,252 | $ | 21,986 | ||||
| Short-term bank deposits | 31,221 | 31,164 | ||||||
| Other current assets | 2,044 | 1,697 | ||||||
| Total current assets | 46,517 | 54,847 | ||||||
| Non-current assets: | ||||||||
| Restricted bank deposits | 360 | 362 | ||||||
| Long-term prepaid expenses | 164 | 182 | ||||||
| Funds in respect of employee rights upon retirement | 407 | 415 | ||||||
| Property, plant and equipment, net | 6,949 | 6,847 | ||||||
| Operating lease right-of-use assets | 1,892 | 2,008 | ||||||
| Total non-current assets | 9,772 | 9,814 | ||||||
| Total assets | $ | 56,289 | $ | 64,661 | ||||
| LIABILITIES, ORDINARY SHARES SUBJECT TO POSSIBLE REDEMPTION AND SHAREHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accruals: | ||||||||
| Trade | $ | 6,188 | $ | 4,331 | ||||
| Other | 3,799 | 4,408 | ||||||
| Deferred revenue | 546 | 658 | ||||||
| Current maturity of operating leases liability | 516 | 529 | ||||||
| Total current liabilities | $ | 11,049 | $ | 9,926 | ||||
| Non-current liabilities: | ||||||||
| Liability for employee rights upon retirement | 580 | 546 | ||||||
| Operating lease liability | 1,657 | 1,823 | ||||||
| Other non-current liability | 205 | 188 | ||||||
| Total non-current liabilities | 2,442 | 2,557 | ||||||
| Total liabilities | $ | 13,491 | $ | 12,483 | ||||
| Ordinary shares subject to possible redemption, 615,366 shares at redemption value (see note 4) | - | 1,598 | ||||||
| Shareholders’ equity: | ||||||||
| Ordinary shares, | 173 | 171 | ||||||
| Additional paid in capital | 311,999 | 309,355 | ||||||
| Warrants | 3,127 | 3,127 | ||||||
| Accumulated deficit | (272,501 | ) | (262,073 | ) | ||||
| Total equity | 42,798 | 50,580 | ||||||
| Total liabilities and equity | $ | 56,289 | $ | 64,661 | ||||
STATEMENTS OF NET LOSS AND COMPREHENSIVE LOSS (UNAUDITED) | ||||||||
| Three Months Ended | ||||||||
| 2022 | 2021 | |||||||
| Revenues | $ | 113 | $ | 185 | ||||
| Cost of revenues | (55 | ) | (90 | ) | ||||
| Gross profit | 58 | 95 | ||||||
| Research and development expenses, net | 7,460 | 4,769 | ||||||
| General and administrative expenses | 3,162 | 1,673 | ||||||
| Operating loss | 10,564 | 6,347 | ||||||
| Financial income | (146 | ) | (84 | ) | ||||
| Financial expenses | 10 | 20 | ||||||
| Financial income, net | (136 | ) | (64 | ) | ||||
| Net loss and comprehensive loss | $ | 10,428 | $ | 6,283 | ||||
| U.S. dollars | ||||||||
| Loss per share (see note 3) | ||||||||
| Basic and diluted | $ | 0.13 | $ | 0.12 | ||||
| Number of shares | ||||||||
| Weighted average ordinary shares outstanding | ||||||||
| Basic and diluted | 77,386,967 | 52,113,675 | ||||||
2022 GlobeNewswire, Inc., source
