Analyst Conference Summary

conference date: November 15, 2021 @ 5:30 AM Pacific Time
for quarter ending: September 30, 2021 (Q3, third quarter 2021)

Forward-looking statements

Overview: VB-111 for ovarian cancer Phase 3 trial on track for complete enrollment Q1 2022.

Basic data (GAAP):

Revenue was $ million, sequentially from $0.2 million, and from $ million year-earlier.

Net income was negative $0.2 million, up sequentially from negative $8.0 million, and flat from negative $0.2 million year earlier.

Diluted earnings per share (EPS) was negative $0.09, up sequentially from negative $0.12, and up from negative $0.12 year earlier.

Guidance:

Expect cash is sufficient into Q4 2023.

Conference Highlights:

Dror Harats, M.D., CEO of VBL Therapeutics said "We continue to execute on our development and strategic objectives which we believe positions 2022 as a potentially transformational year for VBL. We look forward to completing the enrollment in the Phase 3 OVAL study in the first quarter of 2022 and the PFS co-primary endpoint top-line data readout in the second half of 2022. We also expect to initiate a first-in-human trial with VB-601, our monocyte targeting program, in the second half of 2022. With the recent strengthening of our management and board of directors, together with our newly established presence in the United States, we are taking important steps to prepare VBL for continued growth and the planned commercialization of VB-111." A BLA could be filed in 2022 if the PFS results for VB-111 are positive.

The Phase 3 OVAL trial of VB-111 with chemotherapy in platinum-resistant ovarian cancer continued. with complete enrollment expected in Q1 2022. In Q3 2021 the data safety monitoring commitee reviewed data with no problems. Top line data could be available in 2022. An additional primary endpoint, PFS, has been added to the protocol (was just OS). Positive data for either enpoint is expected to support BLA submission. 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 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 VB-111 in recurrent glioblastoma (rGBM) dosed its first patients in March 2021. The IND was submitted by Dana-Farber Cancer Institute. Preliminary data expected in 2H 2022.

The MOSPD2 inflamation (NASH) program, VB-601 submitted a pre-IND to the FDA in June 2020 with plans enter the clinic in 2022 for treatment of rheumatoid arthritis. 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 $50 million, down sequentially from $57 million.

Cost of revenue was $0.1 million. Gross profit $0.1 million. R&D expense $5.0 million. SG&A $1.6 million. Operating loss $6.5 million. Other expense net $0 million.

Q&A summary:

Timeline if PFS readout is positive? We have a commercial grade facility in Israel. Already completed CMC portion of review successfully. Positive PFS should allow for filing a BLA.

Compassionate use plan? Not decided yet. We do not want control arm patients crossing to active because we are measuring PFS and OS. We may keep the study going on to measure OS, if PFS is positive. But we could at some point begin a compassionate use program.

DSMC sees the full data, but we only see the blended data. This is not cleaned data. We have not yet received the results from the latest DSMC meeting.

The colon has a different immune system, so the colon cancer trial is looking to see if we can bring an immune response into the colon.

Is glioblastoma data enough to go the the FDA? Since it is a controlled trial, we could apply for accelerated approval, it would depend on the strength of the data.

601 partnering? Would wait to see Phase 1 data before looking for partners.

We are conducting a search for a Chief Commercial Officer.

Delays in opening trials and in getting data have been pandemic related.

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