Company: INMB
Filing Date: 2025-08-07
Form Type: 10-Q
Source: 0001213900-25-073077
Chunk: 36

Company: Inmune Bio, Inc.
Filing Date: 2025-08-07
Form: 10-Q
Item: Part I, Item 1
Chunk 36
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 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.

27

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/AML trial in March 2024. Nonetheless, from the four patients
treated and completing follow-up it was determined that INKmune therapy is safe and promotes development of cancer killing memory-like
NK cells that are activated and can kill NK-resistant cancer cells which can be found in the patient’s circulation for up to 4 months
after completion of treatment. The Company initiated a separate multicenter Phase I/II trial of INKmune in a metastatic castrate resistant
prostate cancer in the US. The open label trial enrolled the first patient in December 2023 and is currently in Phase II across 6 US sites. 

The Phase I/II trial using
INKmune to treat patients with metastatic castrate