Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 67

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 67
---
 assumptions
prove to be inaccurate, the actual markets for our product candidate could be smaller than our estimates of the potential market opportunities.

Even if we obtain regulatory approvals for
CORDStrom, INKmune and/or any product from our DN-TNF platform those approvals and ongoing regulation of our products may limit how we
manufacture and market our products, which could prevent us from realizing the full benefit of our efforts.

If we obtain regulatory approvals,
CORDStrom, INKmune and/or the DN-TNF product platform, and the manufacturing facilities used for its production will be subject to continual
review, including periodic inspections, by the FDA and other United States and foreign regulatory authorities. In addition, regulatory
authorities may impose significant restrictions on the indicated uses or marketing of INKmune or other products that we may develop. These
and other factors may significantly restrict our ability to successfully commercialize INKmune.

We and many of our vendors
and suppliers will be required to comply with current Good Manufacturing Practices, or GMP, which include requirements relating to quality
control and quality assurance as well as to the corresponding maintenance of records and documentation. Furthermore, any manufacturing
facilities will need to be approved by regulatory agencies before these facilities can be used to manufacture, and they will also be subject
to additional regulatory inspections. Any material changes we may make to our manufacturing process may require approval by the FDA and
state or foreign regulatory authorities. Failure to comply with FDA or other applicable regulatory requirements may result in criminal
prosecution, civil penalties, recall or seizure of products, partial or total suspension of production or withdrawal of a product from
the market.

We must also report adverse
events that occur when our products are used. The discovery of previously unknown problems with CORDStrom, INKmune, the DN-TNF product
platform or manufacturing facilities used to manufacture CORDStrom, INKmune, or the DN-TNF product platform may result in restrictions
or sanctions on our products or manufacturing facilities, including withdrawal of our products from the market. Regulatory agencies may
also require us to reformulate our products, conduct additional clinical trials, make changes in the labeling of our product or obtain
re-approvals. This may cause our reputation in the marketplace to suffer or subject us to lawsuits, including class action suits.

39

If our product candidates receive marketing
approval and we, or others, later discover that the drug is less effective than previously believed or causes undesirable side effects