Company: INMB
Filing Date: 2025-08-07
Form Type: 10-Q
Source: 0001213900-25-073077
Chunk: 68

Company: Inmune Bio, Inc.
Filing Date: 2025-08-07
Form: 10-Q
Item: Part I, Item 2
Chunk 68
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18, 0.39, p-value: 0.2499

Prespecified subgroups analyses
suggested a signal that favored XPro in a predetermined population of patients that were both amyloid positive and had a higher burden
of inflammation defined by 2 or more biomarkers of inflammation (from hereon referred to as enriched group). As shown in figure 2, the
mITT placebo group did not decline whereas patients in the enriched group did decline. Decline in the placebo group is required to test
the ability of a treatment to prevent or slow decline.

20

Figure 2: Phase 2 Study Results – Placebo group decline in
the mITT and enriched population 

Figure 2: Placebo
patients in the mITT did not show decline on the EMACC over the 24 week study. In the enriched group, placebo patients did decline over
24 weeks.

To evaluate a subgroup after missing the primary
endpoint, we used effect size as the primary metric due to the smaller sample size (n=100). Effect size, measured by Cohen’s D,
is well-suited for small samples and allows comparisons across different measures (e.g., cognitive tests and biomarkers). Unlike p-values,
which indicate the likelihood of results being due to chance, effect size reflects clinical relevance and is commonly used for signal
detection in Phase 2 studies.

We defined a promising signal
as a minimum effect size of 0.2, where XPro outperformed placebo on multiple endpoints aligned with our hypothesis and the drug’s
mechanism of action. Results must also be appropriate for the trial’s parameters, meaning the observed effects should align with
the trial’s duration and endpoints. For example, if a clinical measure typically requires a longer time to show meaningful change
than the trial’s 6-month timeframe, an observed effect on that endpoint would not be considered supportive. Signal detection was
based on the effect size difference in LS mean change from baseline (MMRM model) between XPro and placebo at 6 months, ensuring results
were meaningful, relevant, and appropriate for the trial’s design and objectives.

Using this method, the enriched
population (50% of the total sample, n=100) showed trends toward improvement with XPro on the primary endpoint (EMACC) and a key secondary
endpoint (NPI) (Figure 3). With the placebo group showing the expected decline on EMACC over six months, a beneficial effect of
XPro became evident. EMACC