Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 74

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 74
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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 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,