BrainStorm Cell Therapeutics Inc (BCLI)

[Fmello]

This is from a post on the No More Excuses facebook page:

BIOMARKERS
• Bob Brown said the NurOwn trial had: "the most comprehensive analysis of biomarkers we've seen in any study."
• 33 Biomarkers of people in NurOwn treatment arm had favorable changes - regardless of ALSFRS-R
• People in the placebo arm had no favorable changes in biomarkers
• Brainstorm collected CSF biomarkers at 7x during trial
• Brainstorm's Statistical Analysis Plan used AI to identify relevant biomarkers with p-values of .05 or less
• Neurodegeneration Biomarker of NfL decreased for everyone on NurOwn and it reach statistical significance (p-value = .05) at 26+ at the end of 20 weeks
• Neuroinflammatory Biomarkers showed a significant treatment effect with p-value of .0001 in MCP-1 & LAP.
• Neuroprotective Biomarker of VEG-F remained at 150% of baseline & are highly significant throughout the trial. VEG-F p-values were highly statistically significant with p-values at .01 for those of 26+.

FLOOR EFFECT IN ALSFRS
• Floor effect is inability to measure ongoing clinical decline
• No floor effect noted in biomarker data
• Floor effect may have caused trial not to meet its primary endpoint in ALSFRS-R change in slope
• 23% of people had advanced ALS with baseline ALSFRS ≤25
• 37% of people had at least one 0 in Gross Motor Skills domain
• 42% of people had at least one 0 in Fine Motor skills domain
• Per Jeremy Sheffner, up to 70% of decline in trials is measured in gross & fine motor domains, further compounding floor effect