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Edison Investment Research is terminating coverage on Pluristem Therapeutics (PSTI). Please note you should no longer rely on any previous research or estimates for this company. All forecasts should now be considered redundant.
Companies: Pluri Inc.
Edison
Pluristem ended FY18 with an operating loss of $33.7m mostly attributed to R&D expenditure ($22.6m) and as of 30 June 2018 had $30.6m in net cash. The company recently announced its plans to present at several November conferences, including top-line data from its Phase II intermittent claudication (IC) study at the American Heart Association (AHA) Scientific Sessions, as well as an overview of its cell therapy products in clinical development at BioEurope.
In April 2018, Pluristem announced that the FDA had given two pipeline programs IND clearance: PLX-PAD for femoral neck fracture (FNF) healing and PLX-R18 for acute radiation syndrome (ARS). The company plans to initiate the Phase III trial investigating PLX-PAD for FNF healing later this year. IND approval of the PLX-R18 program allows for potential use of the product in the event of radiological emergencies for investigational purposes, which could provide in-human data.
Pluristem continues to advance its PLX technology platform. In a recent paper it investigated the application of these cells for their ability to inhibit tumor growth; it was found that the cells inhibit growth of a mouse xenograft of a triple-negative breast cancer cell line and induced complete remissions in three out of 10 mice. Additionally, PLX-PAD received approval for an expanded access program from the FDA, allowing it to be used to treat critical limb ischemia (CLI) outside the ongoing
Pluristem Therapeutics has had a productive FY18 to date. The company is advancing PLX-PAD in its Phase III study of critical limb ischemia (CLI) and Phase II study of intermittent claudication (IC), with the latter expecting results in early 2018. Additionally, the company received an orphan designation for PLX-R18 for acute radiation syndrome (ARS) currently in non-human primate studies and expanded its Phase I study for support of stem cell transplant to additional sites. We value Pluristem a
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