Table 2:

Histologic Efficacy Analysis – mITT Population

Vh:Cd Ratios	Placebo (N=22)	IMGX003 (N=21)
Visit 2 (Day −14; Baseline)
n	22	21
Mean (SD)	2.95 (0.473)	2.99 (0.326)
Median	2.93	3.00
Minimum, Maximum	2.26, 3.89	2.13, 3.53
Visit 4 (Day 42)
n	22	21
Mean (SD)	2.61 (0.657)	2.95 (0.504)
Median	2.52	2.97
Minimum, Maximum	1.62, 3.73	1.99, 4.20
Change from Baseline to Visit 4 (Day 42)
n	22	21
Mean (SD)	−0.35 (0.616)	−0.04 (0.466)
Median	−0.28	−0.05
Minimum, Maximum	−1.38, 1.01	−1.04, 0.83
Within-Group P-value [1]	.0148	.6713
Between-Group P-value [2]		.0570
IEL	Placebo (N=22)	IMGX003 (N=21)
Visit 2 (Day −14; Baseline)
n	22	21
Mean (SD)	34.55 (13.588)	35.05 (17.279)
Median	38.00	33.00
Minimum, Maximum	12.00, 62.00	10.00, 82.50
Visit 4 (Day 42)
n	22	21
Mean (SD)	59.30 (23.697)	44.83 (22.592)
Median	54.75	37.50
Minimum, Maximum	17.50, 98.50	17.00, 98.50
Change from Baseline to Visit 4 (Day 42)
n	22	21
Mean (SD)	24.75 (22.941)	9.79 (15.741)
Median	24.75	7.00
Minimum, Maximum	−12.50, 66.00	−11.00, 54.00
Within-Group P-value [1]	< .0001	.0099
Between-Group P-value [2]		.0181

^[1]P-value was calculated using a paired t-test of Visit 4 (Day 42) compared to Visit 2 (Day −14) values within each treatment arm and indicates if the change at Visit 4 (Day 42) is statistically significantly different than 0.

^[2]P-value was calculated using a linear regression model including baseline Vh:Cd and treatment as covariates and indicates if the mean change/pct change from baseline at Visit 4 is different between the treatment arms.