Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 349

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1C
Chunk 349
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, a PRV can be redeemed to receive priority review for a different product. Alternatively,
a PRV may be transferred or sold to another sponsor.

The
FDA granted ODD to the Company’s CORDStrom product on January 6, 2025. Benefits of ODD include certain tax credits and eligibility
for select grants, waiver of FDA user fees, including the BLA application fees, access to frequent meetings with the FDA for efficient
drug development, and eligibility for seven (7) years of market exclusivity post approval.

The
company plans to prepare for and hold a pre-BLA meeting to discuss particulars of its planned BLA submission, with intent to submit a
BLA this year seeking approval of CORDStrom for treatment of RDEB. Concurrently, the company will also seek to submit MAAs to the EU and
United Kingdom in 2026.

57

We believe our DN-TNF platform
can be used as a CNS (“central nervous system”) therapy to target glial activation to prevent progression of Alzheimer’s
disease (“AD”); to target neuroinflammation in treatment resistant depression (“TRD”). The primary focus of the
company’s development efforts for XPro is AD. The next indication to be developed with XPro will be TRD. In each case, we believe
neutralizing sTNF is a cornerstone to the treatment of these diseases.

We believe the DN-TNF platform
can be used to treat selected neurodegenerative diseases by reducing neuroinflammation without immunosuppression. The Company believes
the core pathology of cognitive decline is a combination of neurodegeneration and synaptic dysfunction. Neurodegeneration is nerve cell
death that may include demyelination. Synaptic dysfunction means the connections between nerve cells stop working efficiently and may
decrease in number. The combination of neurodegeneration and synaptic dysfunction causes cognitive decline and behavioral changes associated
with Alzheimer’s disease (“AD”). XPro completed a Phase I trial treating patients with Alzheimer’s disease that
was partially funded by a Part-the-Clouds Award from the Alzheimer’s Association. We believe XPro targets activated microglia and
astrocytes of the brain that produce sTNF that promotes nerve cell loss, synaptic dysfunction and prevents myelin repair - key elements
in the development of dementia. In animal models, elimination of sTNF prevents nerve cell dysfunction, reverses synaptic pruning and promotes
myelin repair. The Phase I trial in patients with biomarkers of