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Tuesday, 05/26/2015 8:16:45 PM

Tuesday, May 26, 2015 8:16:45 PM

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Vascular Biogenics (VBLT: Nasdaq) By Roth Capital Partners ($5.05, May 22, 2015)

We are initiating coverage of Vascular Biogenics with a Buy rating and a $13 price target.

Vascular Biogenics (ticker: VBLT) is a clinical-stage-biotechnology company with two technology platforms targeting oncology and immunology indications.

The first platform is Vascular Targeting System (VTS), which is a multi-component gene-therapy design targeting vascular endothelial cells. The second platform is comprised of lecinoxoids, which are synthetic oxidized phospholipid small molecules mimicking naturally occurring anti-inflammatory agents in the body.

Lead focus is on VB-111 with potential for survival benefit in recurrent Glioblastoma (rGBM). Using the VTS platform, VBLT developed VB-111, an anti-angiogenic gene-therapy product specifically targeting angiogenic endothelial cells, thereby leading to their apoptosis such that angiogenesis is impaired. An added benefit of VB-111 is that alongside its anti-angiogenic function, the fusion gene it encodes along with the viral vector, induces a long-term immune reaction. Recent data from a Phase II study in rGBM showed that combination of VB-111 and standard of care, bevacizumab, achieved a statistically significant higher median overall survival (mOS) benefit of 414 days compared to a sequential treatment of VB-111 followed by bevacizumab at 235 days.

Up next: Phase III in rGBM under Special Protocol Assessment (SPA). Vascular Biogenics expects to initiate a Phase III study under SPA in mid-2015. This will be a randomized, placebo-controlled study comparing VB-111 in combination with bevacizumab to bevacizumab alone and the primary endpoint is overall survival.

Additional opportunities: VB-111 is being assessed in a Phase I/II study in platinum-resistant recurrence epithelial ovarian cancer and advanced differentiated radioiodine-resistant thyroid cancer.

Upcoming catalysts: At the upcoming American Society of Clinical Oncology (ASCO) 2015 meeting, investors will receive two updates from the company: 1) Vascular Biogenics will present mature overall survival (OS) data from the Phase II study in rGBM; and 2) Dana-Farber Cancer Institute investigators will present data on the first 14 patients from the Phase I/II study in ovarian cancer. Following ASCO additional catalysts include full data from the ovarian cancer study in the second half and full data from the Phase II study in thyroid cancer in first-half 2016. Interim analysis in the Phase III rGBM study is expected in second-half 2016 with data in second-half 2017.

-- Joseph Pantginis
-- Assaf Vestin
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