Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 185

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 185
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 collaborations to market and
distribute our products. This growth may strain our existing managerial, operational, financial and other resources. We also intend to
add personnel in our research and development and manufacturing departments as we expand our clinical trial and research capabilities.
Any inability to attract and retain qualified employees to enable our planned growth and establish additional capabilities or our failure
to manage our growth effectively could delay or curtail our product development and commercialization efforts and harm our business.

We are subject to a multitude of manufacturing risks, any of which
could substantially increase our costs and limit supply of our drug candidates.

The process of manufacturing
our drug candidates is complex, highly regulated and subject to several risks. For example, the process of manufacturing our drug candidates
is extremely susceptible to product loss due to contamination, equipment failure or improper installation or operation of equipment, or
vendor or operator error. Even minor deviations from normal manufacturing processes for any of our drug candidates could result in reduced
production yields, product defects and other supply disruptions. If microbial, viral, or other contaminations are discovered in our drug
candidates or in the manufacturing facilities in which our drug candidates are made, such manufacturing facilities may need to be closed
for an extended period of time to investigate and remedy the contamination. In addition, the manufacturing facilities in which our drug
candidates are made could be adversely affected by equipment failures, labor shortages, natural disasters, epidemics, pandemics, power
failures and numerous other factors.

In addition, any adverse developments
affecting manufacturing operations of our drug candidates may result in shipment delays, inventory shortages, lot failures, withdrawals
or recalls, or other interruptions in the supply of our drug candidates. We also may need to take inventory write-offs and incur other
charges and expenses for 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.