Vascular Biogenics
(VBL Therapeutics)
VBLT
conference date: May 17, 2018 @ 5:30 AM Pacific Time
for quarter ending: March 31, 2018 (Q1, first quarter 2018)
Forward-looking
statements
Overview: Continues clinical development.
Basic data (GAAP):
Revenue was $0.1 million, up from $0.0 million year-earlier.
Net loss was $7.2 million, from los of $5.0 million year earlier.
Diluted loss per share was $0.24, down from $0.19.
Guidance:
none
Conference Highlights:
Yael Cohen M.D., VP Clinical Development of VBL Therapeutic said “We continue to advance the OVAL trial, our Phase 3 potential registration trial in platinum-resistant ovarian cancer, in collaboration with the GOG Foundation. We are in the process of amending the protocol to include an interim analysis for evidence of an early efficacy signal with a potential readout from this analysis in the fourth quarter of 2019. VBL is well capitalized, with approximately $50 million in cash, which will enable us to continue the development of VB-111 and our deep pipeline through 2020.’ [WPM: I would not call $50 million in cash "well capitalized."]
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. A grant of $2.5 million was received from the Israel Innovation Authority to support development.
A license agreement was signed with NanoCarrier for VB-111 in Japan. A milestone payment was received in February.
VB-600 bispecific antibodies are being developed, with preclinical data presented showing they kill MOSPD2 expressing cancer cells. Plans an IND in Q4 2019. MOSPD2 plays a key roll in cell motility, including cancer cells.
Has a strong preclinical pipeline.
A new gene therapy manufacturing plant was opened in Modiin, Israel.
Cash ended the quarter at $49.9 million, down sequentially from $54.7 million.
Cost of revenue was $0.1 million. Gross profit $0.1 million. R&D expense $5.8 million. SG&A $1.6 million. Operating loss $7.3 million. Other income $0.1 million.
Q&A:
What do you know about the failed VB-111 trial in glioblastoma? We are still analyzing the data. We are looking for any effect in any subgroups. We should be able to be more specific later this summer. We believe the issue of regimen is critical in the difference between the Phase 2 and Phase 3 trials in GBM.
Timeline for ovarian cancer study? The interim analysis in Q4 2019 will have data on at least 60 patients, randomized and blinded. That should tell us if we are getting the same response rate we saw in Phase 11. Chemo alone 11 to 15% response rate, our Phase 2 had about 60% response rate. Full length of study about two and one-half years.
MOSPD2 tumor type priorities? We are still gathering preclinical data, and we have at least 2 molecules in the family. Multiple Sclerosis could be one of the first indications, based on data so far. Efficacy seems as good as major drugs on the market, but safer and longer acting. Also looking at AML, but need to show it can be killed in the bone marrow, not just the blood. Others also possible, as they expess MOSPD2.
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