Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 9

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 9
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 sTNF in the
brain without affecting tmTNF or TNF receptors. Soluble TNF is a cause of the destructive neuroinflammation in the brain are microglial
and astroglial cells (“glial cells”). Glial cell are two of four cells in the neural unit that also includes oligodendrocytes
and nerve cells. Activated microglial cells are considered the resident macrophages of the brain. The primary role of microglial cells
is to protect the neural unit from infection. When innate immune dysfunction causes chronic inflammation, activated microglial cells produce
soluble TNF that activates astrocytes. Activated glial cells cause nerve cell and oligodrocyte dysfunction that results in synaptic pruning,
nerve cell death and demyelination of neurons. These pathologies contribute, in part, to neurodegenerative diseases such as AD, Parkinson’s
disease, ALS, MS, Huntington’s disease, glaucoma and TBI (traumatic brain injury) may contribute to neuropsychiatric diseases such
as depression, bi-polar disease, sleep disorders, autism, schizophrenia and PTSD. In the setting of AD, microglial activation causes synaptic
dysfunction and nerve cell death that contributes to cognitive decline and the behavioral manifestations of AD including depression, aggressiveness,
sleep disorders, hallucinations and anhedonia. Elimination of microglial activation should reverse these symptoms. Because soluble TNF
is the apex cytokine in the inflammatory cytokine cascade, neutralization of soluble TNF with XPro should prevent glial activation and
normalizes function of the neural unit.

The Company has completed
a Phase I trial using XPro to reverse neuroinflammation in patients with Alzheimer’s disease. The trial was performed in Australia
and was partially funded by a $1M USD Part-the-Cloud Award from the Alzheimer’s Association. The clinical trial was the first in
the Company’s development program for the treatment of dementia. The open label, dose escalation trial in patients with Alzheimer’s
disease with biomarkers of peripheral inflammation (one of CRP>1.5mg/L, HgbA1c>6.0, ESR>10sec or have ApoE4) treats the patients
with XPro as a once-a-week subcutaneous injection for 3 months. AD patients with one biomarker of inflammation are classified as having
AD with neuroinflammation (“Adi”). The company estimates