Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 210

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 210
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 commercial uses in exchange for
payment of an initiation milestone of £250,000 (approximately $0.3 million at February 6, 2025) and a single development milestone
of approximately £6 million (approximately $7.5 million at February 6, 2025) due on receipt of first marketing authorization from
the FDA, EMA, or MHRA, and an ongoing commitment to supply CORDStrom to patients enrolled in an open label arm of the Mission EB trial,
subject to certain limitations.

After
reviewing results of the Mission EB study, the Company initiated a Type C meeting with the FDA to obtain 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.

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