Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 72

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 72
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 operations and prospects.

42

We will need to increase the size and capabilities
of our organization, and we may experience difficulties in managing this growth.

To execute our business plan,
we will need to rapidly add other management, accounting, regulatory, manufacturing and scientific staff. We currently have 13 full-time
employees in the United States, 9 full-time employees in the United Kingdom and retain the services of additional personnel on an independent
contractor basis. We will need to attract, retain and motivate a significant number of new additional managerial, operational, sales,
marketing, financial, and other personnel, as well as highly skilled scientific and medical personnel, and to expand our capabilities
to successfully pursue our research, development, manufacturing and commercialization efforts and secure 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