Wednesday, February 06, 2019 10:17:48 PM
U.S /Europe phase III study initiation- Q1/2017
Japan pivotal study initiation – H2 2017
Closing on JV deal with Sosei- Q1/2017
Data from IC phase multinational phase II study, N=172 - early 2018
Interim result from Europe phase III (via adaptive pathway)- H2 2018/H1 2019
Data readout dose selection studies ARS- H1/2017
Contract with U.S. government for ARS – H2/2017
Initiation of pivotal study ARS NHP- H2/2017
Data readout phase I open label HCT- H2/2017
Preclinical data Fukushima- H1/2017
Preclinical data NYBC- H1/2017
Upcoming Milestones – 12 Months
Initiate advanced pivotal (pre-marketing) clinical trials:
• Critical Limb Ischemia (CLI) – U.S., EU, Japan
• Hip fracture – U.S., EU
• ARS
Clinical data readout
• Intermittent Claudication (IC)
• ARS- U.S. NIH dose selection trial
• Incomplete engraftment of hematopoietic cell transplantation – open label
Business development
• Japan- close the Sosei deal and form a JV
• U.S. – negotiating contract with government for ARS
• China- licensing/JV with Chinese partner
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