Vascular Biogenics
(VBL Therapeutics)
VBLT
conference date: March 15, 2018 @ 5:30 AM Pacific Time
for quarter ending: December 31, 2018 (Q4, fourth quarter 2017)
Forward-looking
statements
Overview: Lead gene therapy drug failed Phase 3 in one indication, but has a shot with ovarian cancer Phase 3 now underway.
Basic data (GAAP):
For the full year 2017:
Revenue was $13.8 million.
Net loss was $10.2 million.
Loss per share was $0.37.
Guidance:
none
Conference Highlights:
Dror Harats, M.D., CEO of VBL Therapeutics, said "VBL has more than $50 million in cash, which will enable us to continue the development of VB-111 and our promising pipeline through 2020. We intend to continue the ongoing OVAL trial, our Phase 3 potential registration trial in platinum-resistant ovarian cancer, in collaboration with the GOG Foundation. We intend to add an interim analysis for evidence of efficacy signal in our OVAL trial, sooner than in our original plan. We expect that the interim readout may be available during the first half of 2019."
But the Phase 3 trial of VB-111 plus Avastin for recurrent glioblastoma failed (to be significantly better than Avastin alone). Investigating why positive Phase 2 data was not replicated in Phase 3.
The Phase 3 trial of VB-111 with chemotherapy in platinum-resistant ovarian cancer started. 350 patients will be enrolled. VB-111 has orphan drug designation in this indication. There will be an interim analysis in the first half of 2019.
A license agreement was signed with NanoCarrier for VB-111 in Japan. A milestone payment was received in February.
Has a strong preclinical pipeline.
A new gene therapy manufacturing plant was opened in Modiin, Israel.
Cash ended the quarter at $54.7 million. In November raised $18.75 million with a common stock offering.
Full year 2017: Cost of revenue was $0.34 million. Gross profit $13.5 million. R&D expense $17.8 million. SG&A $6.4 million. Operating loss $10.7 million. Other income $0.5 million.
Q&A:
GBM study responders, when might we see that data? We are still waiting for more data to come. It is hard to know when we will have more information for the market, but perhaps in Q2. There are some patients still taking the combination who remain in full remission, and we will enable them to stay on the drug. "The difference between the Phase 2 and Phase 3 is a big difference."
We do know that in the successful Phase 2 study we gave 111 first to prime patients, then gave Avastin. For the failed Phase 3 trial the FDA insisted we give Avastin first, then 111.
Ovarian analysis interim analysis plan? Still discussing with the trial steering committee and FDA. Looking at biomarkers to see if we are repeating Phase 2 positive results. We had already planned a futility analysis, we are just moving up the timeline, if the FDA agrees. We should be able to give firm information in Q2. The trial will be double blind, and we have not recruited many patients so far, since we know we are changing it.
Preclinical to clinical plan? We are still optimizing antibodies, need to do toxicology.
VBL-201? Will be more willing to discuss it in the near future.
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