Investor Presentaiton
FAS²
ONENESS
Ph3 Clinical Trial Results - Superiority to SOC
MRCT (US, China, Taiwan) in 236 subjects
Primary endpoint-
Incidence of Wound Closure1
Efficacy Endpoints
Secondary Endpoint -
Time to Complete Wound Closure
Cumulated Incidence of Wound Closure
Incidence of Wound Closure (%)
70
70
P=0.0001
60
60.7%
50
40
Probability of healing
1.0
Hazard Ratio 1.80
0.8
95% CI 1.23-2.65
P=0.002
0.6
0.4
70.0%
60.0%
ON101
50.0%
40.0%
30.0%
ON101,
60.7%
Absorbent Dressing,
35.1%
35.1%
30
20.0%
0.2
Absorbent dressing
10.0%
0.0%
20
10
0
Wk2 (V3)
Wk4 (V4)
Wk6 (V5)
Wk8 (V6)
Wk10 (V7) Wk12 (V8)
Wk14 (V9) Wk 16 (V10)
0
14
28
42
56
70
84
98
112
• ON101
Time to complete healing, d
• Absorbent Dressing
No. at risk
0
122 vs 114
ON101
Absorbent dressing 114
122
122
112
119
111
113 101
104
93
888
87
86
87
78
76
29
72
34
69
47
■ON101 Absorbent Dressing
(16 wks)
1 wound closure: Per US FDA guidance, complete reepithelization without drainage or requirement of dressing for consecutive 2 weeks.
2Full analysis set
ON101: Trade name - Fespixon
| 12
SOC: Standard of CareView entire presentation