Analyst Conference Summary

conference date: November 20, 2018 @ 5:30 AM Pacific Time
for quarter ending: September 30, 2018 (Q3, third quarter 2018)

Forward-looking statements

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

Basic data (GAAP):

Revenue was $0.1 million, down sequentially from $0.2 million, and up from $0.0 million year-earlier.

Net loss was $5.4 million, down sequentially from a loss of $4.1 million, and from a loss of $6.5 million year earlier.

Diluted loss per share (EPS) was $0.15, down sequentially from $0.13, and up from $0.24 year earlier.

Guidance:

Has cash sufficient for 3 years of operations.

Conference Highlights:

Dror Harats, M.D., CEO of VBL Therapeutics said "We continue the development of our novel anticancer drug VB-111, as we enroll and treat patients in the ongoing Phase 3 OVAL trial in platinum resistant ovarian cancer while exploring the opportunity to develop it in other indications. We are excited about the potential of our MOSPD2-targeting platform and are advancing two parallel programs exploring MOSPD2 as a therapeutic target in both oncology and inflammatory disease."

The Phase 3 trial of VB-111 with chemotherapy in platinum-resistant ovarian cancer continued enrollment. 350 patients will be enrolled. VB-111 has orphan drug designation in this indication. There will be an interim analysis in Q4 2019.

VBL has a license agreement with NanoCarrier for VB-111 in Japan.

Has a strong preclinical pipeline. The MOSPD2 program goal is to file an IND in Q4 2019 to start clinical trials. VBL presented more preclinical data on VB-600 MOSPD2 platform at the European Committee for Treatment and Research in Multiple Sclerosis (or ECTRIMS) conference on October 11th in Berlin. Also is developing a bi-specific antibody with MOSPD2 as one target; data was presented at the AACR meeting.

Continues to develop its lecinoxoid preclinical program for renal fibrosis.

The previously announced failure in the VB-111 glioblastoma Phase 3 trial may have been impaired by the treatment regimen agreed to under the SPA, as no other risk factor can explain the Phase 3 failure after the positive Phase 2 trial [WPM: except a random false positive or random false negative]. Analysis presented in November 2018 at the Society for Neuro-Oncology meeting indicated that the initial priming with VB-111 without bevacizumab (Avastin) is necessary for effectiveness. Priming with Avastin may blunt the effect of VB-111.

Cash ended the quarter at $53 million, down sequentially from $58.5 million.

Cost of revenue was $0 million. Gross profit $0.06 million. R&D expense $4.2 million. SG&A $1.6 million. Operating loss $5.6 million. Other income net $0.3 million.

Q&A:

MOSPD2 timeline to clinic? We are fine tuning the antibody. Then we will go to production and toxicology. Then to an IND for clinical trials. MOSPD2 is a protein that controls the movement of monocytes to tissues. Animal model is positive and exciting. There is some interest from a strategic partner.

We already modified the ovarian VB-111 trial to be double blind and placebo controlled, and have PFS and OS as endpoints. We will be looking at biomarkers relatively early in the trial to see if those results match the successful Phase 2 trial. Also we are taking biopsies.

There are discussions about further investigation of VB-111 for GBM in an investigator-initiated trial. We would supply the drug but not finance the trial.

Any understanding of why Avastin would block VB-111? Avastin cleans the vessels, while VB-111 is looking for the molecules that Avastin cleans out, so finds no target cells. We thought it might be a little effect, and discussed it with regulators, but it turned out to be a major effect. We did some work with animals to confirm this.

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