Analyst Conference Summary

conference date: August 16, 2021 @ 5:30 AM Pacific Time
for quarter ending: June 30, 2021 (Q2, second quarter 2021)

Forward-looking statements

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

Basic data (GAAP):

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

Net income was negative $8.0 million, down sequentially from negative $6.3 million, and down from negative $5.8 million year earlier.

Diluted earnings per share (EPS) was negative $0.12, flat sequentially from negative $0.12, and up from negative $0.14 year earlier, due to share dilution from 42.7 million to 68.1 million.

Guidance:

Expect cash is sufficient into Q4 2023.

Conference Highlights:

Dror Harats, M.D., CEO of VBL Therapeutics said "With $57.2 million in cash that is projected to fund our operations until year-end 2023, we are excited to advance our OVAL study, with PFS as its additional primary endpoint, towards clinical readout in the second half of 2022. Following the FDA request for additional technical production data on VB-111, we prepared and submitted the requested information in early August and are currently awaiting agency guidance. With several important milestones anticipated through the rest of 2021, we look forward to keeping investors apprised of our progress."

The Phase 3 OVAL trial of VB-111 with chemotherapy in platinum-resistant ovarian cancer continued enrollment. Gave an update on the trial in June 2021 at ASCO. 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 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.

However, in June voluntarilly paused the VB-111 trial in the US to preserve the supply of FDA approved batches. Enrollment continues elsewhere. Agreed with the FDA to provide additional documentation on new batches. Data is still expected in late 2022 and then OS in 2023. Currently available drugs were approved on PFS and did not show OS.

A public stock offering in April raised $26.4 million net.

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 $57 million, up sequentially from $37 million.

Cost of revenue was $0.9 million. Gross profit $0.9 million. R&D expense $6.6 million. SG&A $1.5 million. Operating loss $8.0 million. Other expense net $0 million.

Q&A summary:

Pause of US patients, effect on timeline? Not recruiting new US patients, those on trial are using the approved batches, some for quite a long time. Will not affect DSMC review.

Investigator concern? Disappointed that recruited patients can not start the drug.

MCI colon cancer not paused, had adequate drug.

GBM trial also paused screening for new patients.

R and D spend? Do not expect the Q2 spend to continue for full year, average about $2 million per month. But total R&D expense for 2021 will be higher than for 2020 due to ramping up of trials.

Patients enrolled? Only provide the number when significant. Believes if CMC goes well will still be on timeline for enrollment completion by year end. Does not expect FDA onsite inspection, just data. We got thorough guidance, we believe we sent them what they wanted at the beginning of August.

We do not expect the pause to affect the statistics or population, because most patients had already been enrolled. Up to the pause recruitment was better than anticipated.

OpenIcon Analyst Conference Summaries Main Page

Search

More Analyst Conference Pages: