Cytokinetics, Inc. (CYTK)

[H2R]

Reminder of the Ph III ALS study:
SVC in Benefit ALS was positive with strong p value.

For the Ph III, Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices after Treatment for a Year in ALS (results in Q4):
Study Overview
• Enrolled over 700 patients in 11 countries
Primary endpoint
• Change from baseline in slow vital capacity (SVC) at 24 weeks
Secondary endpoints
• Change from baseline in the ALSFRS-R score of the three respiratory items of the
ALSFRS-R (i.e., the sum of items 10, 11 and 12) at 48 weeks
• Slope of mega-score of muscle strength at 48 weeks
• Time to the first occurrence of a decline from baseline in percent predicted SVC ≥20
percentage points or the onset of respiratory insufficiency or death at 48 weeks
• Time to the first occurrence of a decline in SVC to ≤50% predicted or the onset of
respiratory insufficiency or death at 48 weeks
• Change from baseline in the ALSFRS-R total score at 48 weeks
• Time to the first use of mechanical ventilatory assistance or deat