Company: INMB
Filing Date: 2025-02-10
Form Type: 8-K
Source: 0001213900-25-011733
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Company: Inmune Bio, Inc.
Filing Date: 2025-02-10
Form: 8-K
Item: Item 1.01
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Item
1.01 Entry into a Material Definitive Agreement.

On February 6, 2025, INmune Bio Inc. (the “ Company”) and
Great Ormond Street Hospital NHS Foundation Trust (“ GOSH”) entered into a license agreement (the “ License Agreement”)
for the exclusive commercial use to clinical trial data associated with the Mission EB study (the “ Mission EB study”) investigating
the potential of CORDStrom to treat recessive dystrophic epidermolysis bullosa (“ RDEB”) in pediatric patients. The Company
owns the intellectual property covering CORDStrom, the investigational medicinal product used in the Mission EB study. In addition, the
Company owns intellectual property and maintains trade secret protections covering the manufacturing of CORDStrom.

The Company intends to use the license to prepare applications seeking
marketing authorization of CORDStrom for treatment of pediatric RDEB in each of the U. S. Food and Drug Administration (“ FDA”),
European Medicines Agency (“ EMA”) and Medicines and Healthcare Products Regulatory Agency (“ MHRA”).

Under the terms of the License Agreement, the Company has agreed to an upfront payment of £250,000 (approximately $0.3 million)
within thirty (30) days of the effective date of the License Agreement and a single milestone payment up to £6,000,000 (approximately
$7.5 million) due on the first marketing authorization to be granted by the FDA, EMA or MHRA. The Company has also agreed to certain patient
access obligations, including sponsoring the supply of CORDStrom to United Kingdom patients enrolled in an open label continuation of
the Mission EB study.

The term of the License Agreement shall continue in effect ten (10)
years. The Company may terminate the License Agreement by delivering sixty (60) days written notice to GOSH upon (i) notice from the FDA,
MHRA, or EMA that the results of the Mission EB, are insufficient to support a marketing authorization, or (ii) notice that CORDStrom
has been refused authorized for reimbursement by the National Health Service, or (iii) the Company is unable to procure starting materials
for manufacturing, or to manufacture CORDStrom within eighteen (18) months of the effective date of the License Agreement, in either case
due to regulatory, facility or supply chain events not within the Company’s reasonable control. Either party may terminate the License
Agreement for an uncured material breach by the other