Analyst Conference Summary

conference date: March 23, 2022 @ 5:30 AM Pacific Time
for quarter ending: December 31, 2021 (Q4, fourth quarter 2021)

Forward-looking statements

Overview: Ofra-vec (VB-111) for ovarian cancer Phase 3 trial completed enrollment; BLA planned for 1H 2023.

Basic data (GAAP):

Full year Revenue was $0.77 million.

Full year Net income was negative $30 million.

Full year Diluted earnings per share (EPS) was negative $0.45

Guidance:

Expect cash is sufficient into Q4 2023.

Conference Highlights:

Dror Harats, M.D., CEO of VBL Therapeutics said "2021 was a year of excellent progress for VBL as we advanced our development programs, strengthened our management team and established a direct presence in the United States. The company is positioned for a potentially transformational year in 2022 as we look forward to the PFS primary endpoint top-line data readout in the Phase 3 OVAL trial in the second half of 2022. We are also expecting preliminary data on ofra-vec from the Phase 2 trials in mCRC and rGBM and plan to enter the clinic in the second half of the year with VB-601, the first candidate from our novel anti-inflammatory program targeting monocytes."

The Phase 3 OVAL trial of ofra-vec (VB-111) with chemotherapy in platinum-resistant ovarian cancer continued with enrollment completed in March 2022. The data safety monitoring commitee reviewed data with no problems in March. Top line data (PFS) could be available in 2022. An additional primary endpoint, is OS. Positive data for either endpoint is expected to support BLA submission, likely in 2023. The FDA has approved the commercial facility for its production in Israel.

In February 2020 launched a Phase 2, open-label clinical trial with the National Cancer Institute, of ofra-vec (VB-111) in colon cancer in combination with Opdivo, a checkpoint inhibitor. Preliminary results could be available midyear 2022.

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

The investigator-sponsored Phase 2 trial of ofra-vec (VB-111) in recurrent glioblastoma (rGBM) continued. Preliminary data expected in 2H 2022.

The MOSPD2 inflamation (NASH) program, VB-601 completed pre-IND work. Plans to enter the clinic in 2022 for treatment of rheumatoid arthritis and other inflamatory conditions. 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.

On April 11 with hold a KOL event for investors.

Cash ended the quarter at $54 million, down sequentially from $57 million.

Full year 2021 cost of revenue was $0.4 million. Gross profit $0.4 million. R&D expense $23 million. SG&A $8 million. Operating loss $30 million. Other expense net $0 million.

Q&A summary:

European innovation council accelerator? In December rewarded 17.5 million Euros, 2.5 million is non-dilutive grant. The other 15 million, if finalized, would be shares issued at market.

Phase 2 preliminary data types? Colorectal comparison pre, mono, and combined data. Most colorectal tumors are cold. Hoping ofra-vec will make the tissues hot, so could be combined with checkpoint inhibitors. In GBM is a randomized control trial of patients who have failed surgery and chemo. 1 group ofra-vec, two without, but then 2 of 3 with ofra-vec. Looking for PFS in preliminary data. Later OS.

VB-601 toxicology? We did not see much in toxicity issues, but will still monitor closely while escalating doses in healthy volunteers. Will be looking at biomarkers.

If we get FDA approval in ovarian cancer we hope to move on to many other indications.

Colorectal results timing moved to full 2022 because they come from third parties and are uncertain, we are hoping they are actually near to mid-term.

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