Edison Investment Research - Stemcells Inc (STEM) Initiation: Poised for Phase II

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Edison Investment Research

Initiation: Poised for Phase II

StemCellsâ€™ human neural stem cells (HuCNS-SC) are currently in clinical trials for dry age-related macular degeneration (AMD) and spinal cord injuries (SCI). A Phase II study programme in both indications is underway, following early signs of efficacy in Phase I/II trials. Dry AMD could be a sizeable opportunity (we estimate $2bn in peak sales) and represents the bulk of our overall valuation of StemCells at $189m, or $2.75 per share.

08/01/2015 12 EN

Underlying

Stemcells Inc

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US85857R3030 United States

Provider

Edison Investment Research

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.

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Update: Critical juncture in spinal cord injury

StemCells has reached a critical juncture in its development program with a highly encouraging interim analysis of its Phase II PATHWAY study pointing to promising efficacy in cohort 1 of its human central nervous system stem cells (HuCNS-SC) in lead indication spinal cord injury (SCI). Given limited financial resources, StemCells is realigning operations to focus efforts on the internal funding for key pivotal Phase III SCI trials. New group leadership by way of a recently announced change in CEO comes on the heels of the current company reorganization.

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Update: Phase II trials underway

StemCells has announced transplantation of the first patient in a recently initiated Phase II trial, evaluating its human central nervous system stem cells (HuCNS-SC) as a treatment for dry age-related macular degeneration (AMD). Progression into the Phase II RADIANT trial was supported by the top-line results of its Phase I/II dose-ranging trial in dry AMD announced in June. Additionally, the company began dosing the first cohort in its Phase II PATHWAY study in cervical spinal cord injuries (CSI) earlier this year. At a price of $0.41, the shares offer considerable potential, currently tradi...

September 1, 2015 September 1, 2015 8 EN

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Update: On the PATHWAY towards pivotal studies

StemCells is steadily progressing its pipeline of proprietary human central nervous system stem cells (HuCNS-SC), focusing on CNS disorders. Trials in its two lead indications, spinal cord injuries (SCI) and dry age-related macular degeneration (AMD) are now migrating from early and encouraging dose finding and initial efficacy to larger Phase II studies powered for proof of concept. Early findings are expected to begin feeding through in the current year. We believe StemCells' shares offer considerable value on a current price of $0.74, well below our risk-adjusted fair value calculation of $...

June 8, 2015 June 8, 2015 7 EN

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Initiation: Poised for Phase II

Update: Critical juncture in spinal cord injury

Update: Phase II trials underway

Update: On the PATHWAY towards pivotal studies

Manx Financial Group - Termination of coverage

musicMagpie - Termination of coverage

Topps Tiles - Accelerating growth through Q125

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