Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 4

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 4
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2026 or earlier if possible.
The program has received an ODD and RPD and may be eligible for a Priority Review Voucher if product approval occurs by September 26,
2026. The Company plans to seek scientific advice from the FDA, MHRA and EMA on the program during 2025 in preparation for regulatory
submissions. The regulatory path for therapeutic applications of the mesenchymal stem/stromal cell products is well established and similar
to the regulatory approval process for other cellular medicines. We will only be responsible for regulatory compliance related to manufacturing
of the mesenchymal stromal cells when the product is being developed by a third party. When developing a therapeutic product for the
Company’s commercial portfolio, the Company will be responsible for all aspects of the regulatory process.

CORDStrom is a patent-pending
cell medicine comprising aseptic, allogeneic, pooled HucMSCs in suspension for injection or infusion. The CORDStrom platform leverages,
among other things, proprietary screening, pooling and expansion techniques to create off-the-shelf, allogeneic, pooled HucMSCs as medicines
to treat complex inflammatory diseases. CORDStrom products are designed to provide high-quality, off-the-shelf, batch-to-batch consistent,
scalable, cGMP manufactured, potent cellular medicines that can be produced at low cost and with repeatable specification independent
of donor characteristics. Initially developed at the INKmune manufacturing facilities utilizing United Kingdom academic grant funding,
CORDStrom is a mesenchymal stromal cell (“MSC”) product platform that shows promise as a first systemic therapy for potentially
treating RDEB and many other debilitating conditions. While the first generation CORDStrom product is agnostic to disease indication,
the platform enables creation of indication-specific products, which can be tuned for optimization of anti-inflammatory, immunomodulatory,
homing, and other characteristics.

The CORDStrom product platform
shares many similarities, including reagents, and procedures, with the Company’s INKmune oncology product, enabling the Company
to leverage economies of scale, experienced staff, and other resources to strategically manufacture both products in a rotational campaign
with resource and environmental efficiencies.

2

Overview of Immunotherapy for Cancer

The immune system has two
parts, innate and adaptive. The innate immune system is the body’s first line of defense against an infection, providing immediate,
non-specific responses to eliminate harmful cells in the body.