Company: INMB
Filing Date: 2025-03-07
Form Type: 424B5
Source: 0001213900-25-021719
Chunk: 8

Company: Inmune Bio, Inc.
Filing Date: 2025-03-07
Form: 424B5
Chunk 8
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the FDA, European Medicines Agency (“EMA”), or Medicines and Healthcare Products Regulatory Agency (“MHRA”), and
an ongoing commitment to supply CORDStrom to patients enrolled in an open label arm of the Mission EB study, subject to certain limitations.

After reviewing results
of the Mission EB study, the Company initiated a Type C meeting with the FDA to obtain Chemistry, Manufacturing, and Controls (“CMC”)
and regulatory feedback and submitted information, data and requests for Rare Pediatric Disease and Orphan Drug Designations (“RPDD”/“ODD”).

The FDA granted RPDD to
the Company’s CORDStrom product on December 13, 2024, ahead of the sunset period under Section 529(b)(5) of the Federal Food, Drug,
and Cosmetic Act. As such, CORDStrom remains eligible to receive a Priority Review Voucher (“PRV”) if approved by the FDA
on or prior to September 30, 2026. If granted, a PRV can be redeemed to receive priority review for a different product. Alternatively,
a PRV may be transferred or sold to another sponsor.

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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 UK in 2026.

We believe our dominant-negative tumor necrosis
factor (“DN-TNF”) platform can be used as a CNS (“central nervous system”) therapy to target glial activation
to prevent progression of AD; to target neuroinflammation in 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 neurode