Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 169

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 169
---
 clinical
trials or receive applicable regulatory approvals. Potential investors and shareholders should be aware of the risks, problems, delays,
expenses and difficulties which we may encounter in view of the extensive regulatory environment which controls our business.

If we are unable to keep up with rapid technological
changes in our field or compete effectively, we will be unable to operate profitably.

We are engaged in a rapidly
changing field. Other products and therapies that will compete directly with the products that we are seeking to develop and market currently
exist or are being developed. Competition from fully integrated pharmaceutical companies and more established biotechnology companies
is intense and is expected to increase. Most of these companies have significantly greater financial resources and expertise in discovery
and development, manufacturing, preclinical and clinical testing, obtaining regulatory approvals and marketing than us. Smaller companies
may also prove to be significant competitors, particularly through collaborative arrangements with large pharmaceutical and established
biopharmaceutical or biotechnology companies. Many of these competitors have significant products that have been approved or are in development
and operate large, well-funded discovery and development programs. Academic institutions, governmental agencies and other public and private
research organizations also conduct research, seek patent protection and establish collaborative arrangements for therapeutic products
and clinical development and marketing. These companies and institutions compete with us in recruiting and retaining highly qualified
scientific and management personnel. In addition to the above factors, we will face competition based on product efficacy and safety,
the timing and scope of regulatory approvals, availability of supply, marketing and sales capability, reimbursement coverage, price and
patent position. There is no assurance that our competitors will not develop more effective or more affordable products, or achieve earlier
patent protection or product commercialization, than our own.

Other companies may succeed
in developing products earlier than ourselves, obtaining FDA and European Medicines Agency (“EMA”) approvals for such products
more rapidly than we will, or in developing products that are more effective than products we propose to develop. While we will seek to
expand our technological capabilities in order to remain competitive, there can be no assurance that research and development by others
will not render our technology or products obsolete or non-competitive or result in treatments or cures superior to any therapy we develop,
or that any therapy we develop will be preferred to any existing or newly developed technologies.

We may request priority review for our product
candidate in the future. The FDA may not grant priority review for our product candidate. Moreover, even if the FDA designates such product
for priority review,