Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 60

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 60
---
.

The design of a clinical trial
can determine whether its results will support approval of a product; however, flaws in the design of a clinical trial may not become
apparent until the clinical trial is well advanced or completed. In addition, preclinical and clinical data are often susceptible to varying
interpretations and analyses. Many companies that believed their product candidates performed satisfactorily in preclinical studies and
clinical trials have nonetheless failed to obtain marketing approval for the product candidates. Even if we believe that the results of
clinical trials for our product candidate warrant marketing approval, the FDA or comparable non-U.S. regulatory authorities may disagree
and may not grant marketing approval of our product candidate.

In some instances, there can
be significant variability in safety or efficacy results between different clinical trials of the same product candidate due to numerous
factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations, changes
in and adherence to the clinical trial protocols and the rate of dropout among clinical trial participants. Any clinical trials that we
may conduct may not demonstrate the efficacy and safety necessary to obtain regulatory approval to market our product candidate.

The results of
preclinical studies and early-stage clinical trials may not be predictive of future results. Initial success in clinical trials may not
be indicative of results obtained when these trials are completed or in later-stage trials.

The results of preclinical
studies may not be predictive of the results of clinical trials, and the results of any early-stage clinical trials we commence may not
be predictive of the results of the later-stage clinical trials. In addition, initial success in clinical trials may not be indicative
of results obtained when such trials are completed. In particular, the small number of patients in our planned early clinical trials may
make the results of these trials less predictive of the outcome of later clinical trials. For example, even if successful, the results
of our initial clinical trials for XPro may not be predictive of the results of further clinical trials of this drug candidate or any
of our other drug candidates. Moreover, preclinical and clinical data often are susceptible to varying interpretations and analyses, and
many companies that have believed their drug candidates performed satisfactorily in preclinical studies and clinical trials nonetheless
have failed to obtain marketing approval of their products. Our future clinical trials may not ultimately be successful or support further
clinical development of any of our drug candidates. There is a high failure rate for drug candidates proceeding through clinical trials.
A number of companies in