Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 97

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 97
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, including reduced skin involvement and less pain as well as large reduction in itch.  The younger patients (less
than 10 years old) showed improvements in skin score, indicating better skin integrity and reduced disease activity. Interviews with patients
and caregivers on completing follow up strongly support the clinical benefits of the therapy; both caregivers and patients were able to
correctly identify which treatment had been CORDStrom and which had been placebo. Those who completed the study are asking to continue
on therapy, which the Company intends to pursue as an open-label study.

56

The Mission EB data form the basis of a license that was entered into
between INmune Bio and GOSH, whereby the Company gains exclusive access to the clinical study data for 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