Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 34

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 34
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, 2025, the Company and Great Ormond Street Hospital NHS
Foundation Trust (“GOSH”) executed an exclusive commercial use license to clinical trial data associated with the MissionEB
trial (ISRCTN14409785). The Company owns the intellectual property covering the CORDStrom product, the investigational medicinal product
(“IMP”) used in the MissionEB trial. In addition, the Company owns IP and maintains trade secret protections covering the
manufacturing of CORDStrom. With this license to the clinical trial data, the Company intends to prepare applications seeking marketing
authorization of CORDStrom for treatment of pediatric recessive dystrophic epidermolysis bullosa (“RDEB”) in each of the FDA,
EMA, and MHRA. Terms of the GOSH license include an upfront payment of £250,000 (approximately $0.3 million at February 6, 2025)
and a single milestone payment of up to £6,000,000 (approximately $7.5 million at February 6, 2025) due on the first to occur marketing
authorization to be granted by the FDA, EMA or MHRA. While these things can be unpredictable, the Company is targeting a first marketing
authorization in 2026, which upon occurrence would render the single milestone obligation due for payment. In addition to these financial
terms, the Company has agreed to certain patient access obligations, including sponsoring the supply of CORDStrom to United Kingdom patients
enrolled in an open label continuation of the MissionEB trial.

20

INKmune Research and Development

We expect to use third parties
to conduct our preclinical and clinical trials under the direct supervision of management.

INKmune Manufacturing

We intend to contract with
third parties for the manufacture of our compounds for investigational purposes, for preclinical and clinical testing and for any FDA
approved products for commercial sale. Pre-clinical and clinical material for the early clinical trials with INKmune has been manufactured
under the direction of Mark Lowdell at a licensed Good Manufacturing Practice (“GMP”) facility. The master cell bank, working
cell bank and individual product doses were completed in July 2018. This clinical material is planned for use in the Phase I/II clinical
trials. As we progress in our clinical programs, additional working cell banks and therapeutic product will be produced from the existing
master cell bank. This process takes approximately 6 months and is not anticipated to delay the initiation or