Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 423

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 2
Chunk 423
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 by the Australian government, and such incentives
are reflected as a reduction of research and development expense. The Australian research and development tax incentive is recognized
when there is reasonable assurance that the incentive will be received, the relevant expenditure has been incurred and the amount of the
consideration can be reliably measured.

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Substantially all of our research
and development expenses to date have been incurred in connection with our current and future product candidates. We expect our research
and development expenses to increase significantly for the foreseeable future as we advance an increased number of our product candidates
through clinical development, including the conduct of our planned clinical trials and manufacturing drug to be used in those clinical
trials. The process of conducting clinical trials necessary to obtain regulatory approval is costly and time consuming. The successful
development of product candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing or costs required
to complete the remaining development of any product candidates. This is due to the numerous risks and uncertainties associated with the
development of product candidates.

The costs of clinical trials
may vary significantly over the life of a project owing to, but not limited to, the following:

    ●
    per patient trial costs;

    ●
    the number of sites included in the clinical trials;

    ●
    the countries in which the clinical trials are conducted;

    ●
    the length of time required to enroll eligible patients;

    ●
    the number of patients that participate in the clinical trials;

    ●
    the number of doses that patients receive;

    ●
    the cost of comparative agents used in clinical trials;

    ●
    the drop-out or discontinuation rates of patients;

    ●
    potential additional safety monitoring or other studies requested by regulatory agencies;

    ●
    the duration of patient follow-up;

    ●
    the efficacy and safety profile of the product candidate; and

    ●
    the cost of manufacturing, finishing, labeling and storage drug used in the clinical trial

We do not expect any of our
product candidates to be commercially available for at least the next several years, if ever. We expect to continue to incur significant
expenses and increasing operating losses for the foreseeable future, which may fluctuate significantly from quarter-to-quarter and year-to-year.
We anticipate that our expenses will increase substantially as we:

    ●
    continue research and development, including preclinical and clinical development of our existing product candidates;

    ●
    potentially seek regulatory approval for our product candidates;

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