Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 36

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 36
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 commercial and/or development opportunities warrant such expansion. At the current time, we expect this program to
be funded by revenues from commercial sales. The agreement with AN terminates on November 29, 2027. AN may terminate the license on written
notice to us, if a donor withdraws consent to the continued use of umbilical cord tissue samples that were obtained by AN. Additionally,
either party may terminate the agreement on 30 days prior written notice to the other if that other party materially breach any term of
the agreement and such breaches (to the extent it is remediable) is not remedied within 30 days of the written request to the other party
to do so.

21

Challenges in the Market for Immunotherapy
Products

Government Regulation

The FDA and other federal,
state, local and foreign regulatory agencies impose substantial requirements upon the clinical development, approval, labeling, manufacture,
marketing, and distribution of drug products. These agencies regulate, among other things, research and development activities and the
testing, approval, manufacture, quality control, safety, effectiveness, labeling, storage, record keeping, advertising and promotion of
our product candidates. The regulatory approval process is generally lengthy and expensive, with no guarantee of a positive result. Moreover,
failure to comply with applicable FDA or other requirements may result in civil or criminal penalties, recall or seizure of products,
injunctive relief including partial or total suspension of production, or withdrawal of a product from the market.

Various regulatory authorities
regulate, among other things, the research, manufacture, promotion, and distribution of drugs in the United States under the FDA and other
statutes and implementing regulations. The process required by the FDA before prescription drug product candidates may be marketed in
the United States generally involves the following:

    ●
    completion of extensive nonclinical laboratory tests, animal studies and formulation studies, all performed in accordance with the FDA’s Good Laboratory Practice regulations;

    ●
    submission to the FDA of an investigational new drug application, or IND, which must become effective before human clinical trials may begin;

    ●
    for some products, performance of adequate and well-controlled human clinical trials in accordance with the FDA’s regulations, including Good Clinical Practices, to establish the safety and efficacy of the product candidate for each proposed indication;

    ●
    submission to the FDA of a new drug application or NDA;

    ●
    satisfactory completion of an FDA preapproval inspection of the manufacturing facilities at which the product is produced to assess compliance with current