Analyst Conference Summary

conference date: May 11, 2021 @ 5:30 AM Pacific Time
for quarter ending: March 31, 2021 (Q1, first quarter 2021)

Forward-looking statements

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

Basic data (GAAP):

Revenue was $0.2 million, down sequentially from $na million, and up from $0.4 million year-earlier.

Net income was negative $6.3 million, flat sequentially from negative $na million, and down from negative $5.4 million year earlier.

Diluted earnings per share (EPS) was negative $0.12, up sequentially from negative $na, and up from negative $0.15 year earlier.

Guidance:

Expect cash is sufficient into Q4 2023.

Conference Highlights:

Dror Harats, M.D., CEO of VBL Therapeutics said "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. 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." Current cash position is over $60 million dollars, enough to get to the potential BLA submission.

The Phase 3 OVAL trial of VB-111 with chemotherapy in platinum-resistant ovarian cancer continued enrollment as planned, reaching 50%. In February, with 200 patients enrolled, a successful pre-planned DSMC review of the OVAL study found no safety issues with the trial and recommended its continuation as planned. The next DSMC interim analysis will be in Q3 2021. 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. Expect to achieve full enrollment in late 2021.

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.

In March, 2021 VBL announced the initiation of randomized, controlled, blinded trial of VB-111 for recurrent Glioblastoma Multiforme.

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 $37 million, up sequentially from $31 million. In Q1 raised $32.3 million. So far in Q2 raised $28.3 million.

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

Cost of revenue was $0 million. Gross profit $0 million. R&D expense $4.8 million. SG&A $1.7 million. Operating loss $6.3 million. Other expense net $0 million. The R&D expense is net of government grants.

Q&A summary:

Oval update at ASCO? Abstracts will be public May 19.

Oval geographic enrollment? Major part is in US, the most important market. Israel and EU recruitment is going well, now over 2/3 of patients, so on track to complete enrollment by year-end. We expect some patients in Japan in the near future.

Colorectal study? GBM trial is going well, recruiting patients. Colorectal is going well, done with NCI, looking to see if the immune system can be brought into the gut, which works differently from the other tissues we have studied. Should have some data later on this year, depends on number of biopsy specimens.

Covid study? VB201 could help, but not in time given other therapies. We did start the trial in Israel, the therapy could have a role in other viral diseases.

VB601, MOSPD2? Finishing IND enabling studies, creating a batch for clinical trial. First in man in 2022.

OpenIcon Analyst Conference Summaries Main Page

Search

More Analyst Conference Pages: