Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 186

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 186
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 Poor control
of production processes can lead to the introduction of contaminants or to inadvertent changes in the properties or stability of our drug
candidates that may not be detectable in final product testing. We or our contract manufacturers must supply all necessary documentation
in support of an NDA or marketing authorization application, or MAA, on a timely basis and must adhere to GLP and cGMP regulations enforced
by the FDA, EMA or comparable foreign authorities through their facilities inspection program. Some of our contract manufacturers may
not have produced a commercially approved pharmaceutical product and therefore may not have obtained the requisite regulatory authority
approvals to do so. The facilities and quality systems of some or all of our third-party contractors must pass a pre-approval inspection
for compliance with the applicable regulations as a condition of regulatory approval of our drug candidates or any of our other potential
products. In addition, the regulatory authorities may, at any time, audit or inspect a manufacturing facility involved with the preparation
of our drug candidates or any of our other potential products or the associated quality systems for compliance with the regulations applicable
to the activities being conducted. Although we oversee the contract manufacturers, we cannot control the manufacturing process of, and
are completely dependent on, our contract manufacturing partners for compliance with the regulatory requirements. If these facilities
do not pass a pre-approval plant inspection, regulatory approval of the products may not be granted or may be substantially delayed until
any violations are corrected to the satisfaction of the regulatory authority, if ever.

43

The regulatory authorities
also may, at any time following approval of a product for sale, audit the manufacturing facilities of our third-party contractors. If
any such inspection or audit identifies a failure to comply with applicable regulations or if a violation of our product specifications
or applicable regulations occurs independent of such an inspection or audit, we or the relevant regulatory authority may require remedial
measures that may be costly or time consuming for us or a third party to implement, and that may include the temporary or permanent suspension
of a clinical trial or commercial sales or the temporary or permanent closure of a facility. Any such remedial measures imposed upon us
or third parties with whom we contract could materially harm our business, financial condition and results of operations.

If we or any of our third-party manufacturers fail
to maintain regulatory compliance, the FDA, EMA or comparable foreign authorities can impose regulatory sanctions including, among other
things, refusal to approve a pending application for a drug candidate, withdrawal of an approval, or suspension