Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 73

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 73
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 drug candidates that fail to meet specifications, undertake costly remediation efforts, or seek costlier manufacturing
alternatives.

We and our contract manufacturers are subject to significant regulation
with respect to manufacturing our drug candidates. The manufacturing facilities on which we rely may not continue to meet regulatory requirements.

All entities involved in the
preparation of therapeutics for clinical trials or commercial sale, including our existing contract manufacturers for our drug candidates,
are subject to extensive regulation. Components of a finished therapeutic product approved for commercial sale or used in late-stage clinical
trials must be manufactured in accordance with cGMP. These regulations govern manufacturing processes and procedures and the implementation
and operation of quality systems to control and assure the quality of investigational products and products approved for sale. 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