Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 41

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 41
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 The biomarker directed Phase I trial was performed in AUS
using a regulatory strategy identical to that used for INB03 in cancer. Regulatory approval to initiate the trial was received on February
8, 2019. XPro treats microglial activation and innate immune dysregulation may be the cause with Alzheimer’s disease in some patients.
To our knowledge, there are few companies using an anti-inflammatory strategy for the treatment of Alzheimer’s disease. Those companies
include Denali Therapeutics (NASDAQ: DNLI); developing DNL747 that targets critical signaling proteins in the TNF pathway that regulate
inflammation and cell death. Alector (NASDAQ: ALEC) in partnership with Abbvie is developing AL002 that targets TREM2 on microglial cells.
Gliacure is targeting microglial cells in Alzheimer’s disease with a small molecule candidate GC021109.

Lecanemab (Leqembi™;
Eisai) was approved for the treatment of patients with Early AD in January 2023 This is this the second anti-amyloid drug for the treatment
of early AD to be approved. Donanemab (Lilly), a third drug anti-amyloid therapy for early AD is expected to be approved 2Q24. These two
drugs have similar efficacy and safety profiles. One of the common safety problems is the development of ARIA (Alzheimer’s Related
Imaging Abnormality) that causes a delay or discontinuation of therapy. ARIA is neuroinflammation related side-effect more common in patients
expressing ApoE4. The modest efficacy, sub-optimal safety and difficulty of use makes combination therapy for the treatment of early AD
an attractive development and therapeutic strategy. The Company is following the developments in this area closely. The Company believes
the anti-amyloid therapies will slowly develop market share, but due to their safety and efficacy profile, there will be demand for safer
and more efficacious therapies that do not target amyloid.

24

Clinical testing must satisfy
extensive FDA regulations. Reports detailing the results of the clinical trials must be submitted at least annually to the FDA and safety
reports must be submitted for serious and unexpected adverse events. Success in early-stage clinical trials does not assure success in
later stage clinical trials. The FDA, an IRB or we may suspend a clinical trial at any time on various grounds, including a finding that
the research subjects or patients are being exposed to an unacceptable health risk.