Analyst Conference Summary

Vascular Biogenics
(VBL Therapeutics)

VBLT

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 topline data expected in 2022.

Basic data (GAAP):

Revenue was $0.1 million.

Net income was negative $10 million.

Diluted earnings per share (EPS) was negative $0.13

Guidance:

Expect cash is sufficient into 2H 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 have positioned us for a potentially transformational year. 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."

Two abstracts highlighting ofra-vec clinical research will be presented at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting, June 3-7, 2022. The 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.

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 April 2022 received FDA fast-track designation.

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

The MOSPD2 inflamation (NASH) program, VB-601 completed pre-IND work. On May 8 2022 presented new preclinical data on monocytes. 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 first in human trial is planned for 2H 2022.

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 $44 million, down sequentially from $54 million.

Cost of revenue was $0 million. Gross profit $0 million. R&D expense $7.5 million. SG&A $3 million. Operating loss $1-/5 million. Other expense net $0 million.

Q&A selective summary:

$17 million Euros in cash number? None yet, expect the grant portion and equity portions should come in the next few months.

Scope of ASCO posters? Not topline results, trials are still in progress.

Op ex spend going forward? Q2 will be a pretty heavy quarter due to Oval trial. Then should normalize for studies, but ramp up pre-commercial activities.

Payer feedback on Ofra-vec is they expect to pay in the high range. For PARP inhibitors they are paying about $25,000 per month, ours is every eight weeks [and better?]. They say it is a no brainer for a drug like this.

The first target for VB-601, presuming good healthy volunteer results, will be MS.

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Disclaimer: My analyst call summaries may include both condensations of statements made by company representatives and my own analysis. They are not covered by any warranty. I cannot guarantee anything said by company representatives is true. I try not to make errors, but it is possible. These are my personal notes which I share with other investors and which I use as the basis of my blog and Seeking Alpha articles.

Copyright 2022 William P. Meyers