Company: INMB
Filing Date: 2025-08-07
Form Type: 10-Q
Source: 0001213900-25-073077
Chunk: 73

Company: Inmune Bio, Inc.
Filing Date: 2025-08-07
Form: 10-Q
Item: Part I, Item 2
Chunk 73
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 Intermediate group patients showed a broader range of improvements, 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.

26

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 June 30, 2025) and a single development milestone of approximately £6 million (approximately $7.8 million at June 30,
2025) due on receipt of first marketing authorization from the FDA, EMA, or MHRA, which has not occurred yet, 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, assuming the PRV program is not extended. 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 organization.

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