Analyst Conference Summary

Vascular Biogenics
(VBL Therapeutics)

VBLT

conference date: May 15, 2019 @ 5:30 AM Pacific Time
for quarter ending: March 31, 2019 (Q1, first quarter 2019)


Forward-looking statements

Overview: Continues clinical development, with VB-111 for ovarian cancer in a Phase 3 trial with an interim efficacy readout expected before the end of 2019.

Basic data (GAAP):

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

Net loss was $ million, down sequentially from a loss of $ million, and from a loss of $6 million year earlier.

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

Guidance:

Has cash sufficient for operations through 2021.

Conference Highlights:

Dror Harats, M.D., CEO of VBL Therapeutics said "We expect two additional VB-111 clinical trials to begin this year, a Phase 2 trial in colon cancer in combination with a checkpoint inhibitor (in collaboration with the National Cancer Institute) and an investigator-sponsored study in recurrent glioblastoma which will be conducted by a group of top US neuro-oncology centers. Therefore, together with the ongoing Phase 3 OVAL pivotal study in ovarian cancer, there will be a total of three VB-111 clinical trials up and running in the second half of 2019. We are also pleased to announce that there will be two presentations on VB-111 at the upcoming 2019 ASCO Annual Meeting in early June, by Dr. Richard Penson from Massachusetts General Hospital on the final Phase 2 results in ovarian cancer, and by Dr. Benjamin Ellingson from UCLA on VB-111 Phase 2 and Phase 3 MRI data in recurrent GBM. We are also moving forward with two parallel development programs targeting MOSPD2, which has significant potential as a therapeutic target for both inflammatory diseases and cancer."

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

At the 2018 Society of Gynecologic Oncology conference data presented showed that in 3 out of 3 ovarian cancer patients, VB-111 induced recruitment of infiltrating T-cells into the tumor, turning it from cold to hot. This suggests that VB-111 may be applied to other cold tumors in which checkpoint inhibitors show limited or no efficacy. We are encouraged that in the open label part of the Phase 3 study, data seem to recapitulate the activity of VB-111 in our prior Phase 2 trial for ovarian cancer. We expect the launch of a Phase 2 clinical trial with the National Cancer Institute, of VB-111 in colon cancer in combination with a checkpoint inhibitor, in 2H 2019.

Despite the failure of the earlier Phase 3 trial, we see renewed interest from the oncology community in the potential of VB-111 to treat recurrent Glioblastoma (rGBM) based on MRI analyses performed by UCLA. This seems to indicate the monotherapy was more effective than the combination therapy used in the Phase 3 trial. Recruitment in an investigator-sponsored study for VB-111 in rGBM is expected to commence in Q2 2019.

In 2018 signed a strategic exclusive option license agreement for VB-201, an anti-inflammatory molecule, for veterinary use, with potential payments to VBL that may exceed 50 million euros during the license term. Partner was not named, nor the upfront payment amount. VBL retained worldwide rights for VB-201 for the treatment of humans.

Has a strong preclinical pipeline. The MOSPD2 program goal is to file an IND in 2020 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 in October 2018.

Continues to develop its lecinoxoid preclinical program for renal fibrosis.

An IND for bi-specific antibody for treatment of solid tumor indications is planned for 2H 2020.

Cash ended the quarter at $ million, down sequentially from $50.5 million.

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

Q&A:

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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 2019 William P. Meyers