Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 187

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 187
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 of production. As a result,
our business, financial condition and results of operations may be materially and adversely affected.

Additionally, if supply from one manufacturer is
interrupted, an alternative manufacturer would need to be qualified through an NDA supplement or MAA variation, or equivalent foreign
regulatory filing, which could result in further delay. The regulatory agencies may also require additional studies or trials if a new
manufacturer is relied upon for commercial production. Switching manufacturers may involve substantial costs and is likely to result in
a delay in our desired clinical and commercial timelines.

These factors could cause us to incur higher costs
and could cause the delay or termination of clinical trials, regulatory submissions, required approvals, or commercialization of our drug
candidates. Furthermore, if our suppliers fail to meet contractual requirements and we are unable to secure one or more replacement suppliers
capable of production at a substantially equivalent cost, our clinical trials may be delayed, or we could lose potential revenue.

If we or our third-party manufacturers use
hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages.

Our research and development
activities involve the controlled use of potentially hazardous substances, including chemical and biological materials, by us and any
third-party manufacturers. We and such manufacturers will be subject to federal, state and local laws and regulations in the United States
governing the use, manufacture, storage, handling and disposal of medical and hazardous materials. Although we will seek to ensure that
our procedures for using, storing and disposing of these materials comply with legally prescribed standards, we cannot completely eliminate
the risk of contamination or injury resulting from medical or hazardous materials. As a result of any such contamination or injury, we
may incur liability or local, city, state or federal authorities may curtail the use of these materials and interrupt our business operations.
In the event of an accident, we could be held liable for damages or penalized with fines, and the liability could exceed our resources.
We do not have any insurance for liabilities arising from medical or hazardous materials. Compliance with applicable environmental laws
and regulations is expensive, and current or future environmental regulations may impair our research, development and production efforts,
which could harm our business, prospects, financial condition or results of operations.

We plan to rely on third parties to conduct
clinical trials for our product candidates. Any failure by a third party to meet its obligations with respect to the clinical development
of our product candidate may delay or impair our ability to obtain regulatory