Company: INMB
Filing Date: 2025-10-30
Form Type: 10-Q
Source: 0001213900-25-104141
Chunk: 36

Company: Inmune Bio, Inc.
Filing Date: 2025-10-30
Form: 10-Q
Item: Part I, Item 1
Chunk 36
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DD/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 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.

26

We have demonstrated that
INKmune improves the ability of the patient’s own NK cells to attack their tumor. INKmune interacts with the patient’s NK
cells to convert them from inert resting NK cells into memory-like NK cells that kill the patient’s cancer cells. INKmune is designed
to be given to patients after their immune system has recovered after cytotoxic chemotherapy to target the residual disease that remains
after treatment with cytotoxic therapy. We believe INKmune can be used to treat numerous hematologic malignancies and solid tumors including
leukemia, multiple myeloma, lymphoma, lung, ovary, breast, renal and prostate cancer. The Company sponsored a Phase I trial using INKmune
to treat patients with high risk MDS/AML, a form of leukemia in the UK. Due to Covid restrictions only one patient completed treatment
and follow-up in the Phase I trial for MDS; a further three AML patients were treated compassionately. Due to the post-Covid recruitment
problems, the Company decided to terminate further enrollment in the MDS