Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 14

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 14
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Drugs from the DN-TNF platform
will be developed using adequately powered, well designed studies with the goal to demonstrate a meaningful clinical benefit to patients.
Beyond Phase I, these will most often be blinded, randomized clinical trials using validated end-points that have been authorized by a
regulatory authority – the FDA, TGA, MHRA, EMA, Health Canada, etc. Currently, all planned studies will be performed in North America,
Australia, EU and/or the United Kingdom. Because there are no therapies similar to XPro approved in any market, we plan to take advantage
of the regulatory opportunities afforded to therapies that treat markets with a high unmet need. In the U.S., this includes Orphan Drug
Designation and expedited programs for approval including Accelerated Approval, Breakthrough Therapy Designation, Fast Track Designation,
and priority review (see the section entitled “Government Regulation”). We cannot predict which, if any, of these programs
we will benefit from without further discussions with the FDA, EMA and other competent regulatory authorities.

Immunotherapy for Treatment of Alzheimer’s Disease 

XPro is being developed for
the treatment of Alzheimer’s disease. Microglial activation and neuroinflammation are important causes of the synaptic dysfunction
and nerve cell death that causes cognitive decline in patient with dementia and Alzheimer’s disease. The relationship between β
amyloid plaques and tau neurofibrillary tangles, the traditional targets in AD drug development and neuroinflammation is complex. We believe
targeting plaques and tangles will have limited benefit. Targeting neuroinflammation, the common pathway leading to synaptic dysfunction
and nerve cell death, may be an effective treatment strategy. Substantial pre-clinical data supports the use of XPro in murine models
of AD. Substantial indirect data supports use of XPro in humans including a decreased risk of AD in patients treated with non-selective
TNF inhibitors for rheumatoid arthritis and treatment using direct injection into paraspinous venous plexus. Because of different mechanism
of action of XPro compared to the non-selective TNF inhibitors, we expect a lower risk of immunosuppression and demyelinating complications
such as multiple sclerosis (“MS”). The Company reported preliminary data on July 13, 2020 and January 21, 2021 supporting
the use of XPro to decrease neuroinflammation in patients with Alzheimer’s disease and biomarkers of peripheral inflammation (see
above).