Analyst Conference Summary

conference date: March 25, 2021 @ 5:30 AM Pacific Time
for quarter ending: December 31, 2020 (Q4, fourth quarter 2020)

Forward-looking statements

Overview: Continues clinical development, with VB-111 for ovarian cancer in a Phase 3 trial.

Basic data (GAAP):

Did not report Q4 numbers, just annual.

Revenue was $na million, down sequentially from $0.1 million, and up from $0.0 million year-earlier.

Net income was negative $na million, flat sequentially from negative $5.8 million, and down from negative $ million year earlier.

Diluted earnings per share (EPS) was negative $na, up sequentially from negative $0.12, and up from negative $ year earlier.

Full year 2020 results are below.

Guidance:

Expect cash is sufficient into Q4 2022.

Conference Highlights:

Dror Harats, M.D., CEO of VBL Therapeutics said "2020 was year of significant progress for VBL as we reached several milestones across multiple assets in different stages of development, including a successful interim analysis and two subsequent successful DSMC reviews for the OVAL Phase 3 registration enabling study of VB-111 for the treatment of platinum-resistant ovarian cancer. We look forward to continuing this momentum in 2021."

The Phase 3 OVAL trial of VB-111 with chemotherapy in platinum-resistant ovarian cancer continued enrollment as planned, reaching 50%. In Q2 2020 the first interim results were presented at ASCO20 Virtual Scientific Program. In Q3 the DSMC second interim analysis determined the study should continue as planned, based on unblinded data from the first 100 patients. The planned enrollment is 400. The un-blinded first interim data from the ongoing OVAL study determined that the study has met the interim pre-specified criterion, of an absolute percentage advantage of 10% or higher in CA-125 response in the VB-111 treated arm compared to control. The CA-125 response rate observed in the Phase 3 interim analysis is at least as good as the response rate seen in Phase 2. OVAL study recruitment is going well and being extended to additional geographies. The DSMC recommended continuation in Q1 2021 after looking at 200 patients. The next review is in Q3 2021. Expect to achieve full enrollment in late 2021 or early 2022.

In February 2020 launched a Phase 2, open-label clinical trial with the National Cancer Institute, of VB-111 in colon cancer in combination with Opdivo, a checkpoint inhibitor. Preliminary results could be available midyear 2021.

VB-201 dosed first Covid-19 patients in January 2021. VB-201 is an immune-modulator molecule.

R&D day April 6.

The investigator-sponsored Phase 2 trial of VB-111 in recurrent glioblastoma (rGBM) dosed its first patients in March 2021. The IND was submitted by Dana-Farber Cancer Institute. Despite the failure of the earlier Phase 3 trial, we see renewed interest from the oncology community.

The MOSPD2 inflamation (NASH) program, VB-601 submitted a pre-IND to the FDA in June 2020 with plans enter the clinic in 2H 2021. VBL will present more data at the International Liver Congress in 2020. VBL presented new data at the European League Against Rheumatism (EULAR) onthe potential of proprietary anti-MOSPD2 antibodies for treatment of rheumatoid arthritis. The treatment reduced >50% of disease severity and blocked further disease progression. Anti-MOSPD2 demonstrated higher activity than anti-TNFa in the advanced phase of the disease. Also published a paper on the potential to treat multiple sclerosis.

The cancer version of MOSPD2 antibodies will be the bispecific VB-611, with encouraging preclinical data presented at AACR in Q2 2020. IND second half of 2021.

Cash ended the quarter at $30.8 million, down sequentially from $37 million.

In January 2021 agreed to up to $20 million in share purchases with Aspire Capital Fund.

Cost of revenue was $na million. Gross profit $ million. R&D expense $ million. SG&A $ million. Operating loss $ million. Other expense net $0 million. The R&D expense is net of government grants.

Full year 2020 revenue was $0.9 million. Net loss $24.2 million. EPS loss $0.55. Total share count 43.7 million, up from 35.9 million year-earlier.

Q&A summary:

OVAL interim in Q3? DSMC looks at unblinded data every 6 months. We pay no statistical price, but they get the full statistics, except quality of life. We see the full data, but blinded. We don't release that because it is a registrational trial. There are criteria for petitioning the FDA to stop the trial early.

The GBM Phase 2 trial is our second. The Phase 3 trial had failed because Avastin blocked the effect of VB-111. We are particularly interested in tumor samples and biology in the new trial. We are comparing any standard of care therapy to VB-111. Just 45 patients in 3 groups of 15.

We have more than 70 center open internationally, including Spain and Poland and should be in the UK soon. Japan first patient dosing should be soon.

MOSP2 update? Did dose ranging in monkeys, completely cleared. Still working on histology and final report before submitting IND, but already working on producing clinical-quality drug.

90% of colon cancers are cold tumors, so checkpoint inhibitors don't work. We chose it because of the major need and because NCI came to us and asked to do a trial. No knowledge of what results will be. It is a small trial, funded by NCI.

PARP inhibitor success for ovarian cancer is great, but few people carry the gene and most can't continue of PARP.

Explained reason for VB-201, why can't compete in many indications against other drugs, why it could work for Covid-19 and other indications like HIV.

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