Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 1

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 1
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 pathways that allow the treatment of neurodegenerative diseases in patients with our lead product candidate, XPro;

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    Pursue development strategies and regulatory approval pathways that allow the treatment cancer with our lead oncology platform, INKmune;

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    Adopt a product development strategy that solidifies our existing intellectual property (“IP”) to prevent competition and expand our IP suite into related immunotherapeutic areas;

    ●
    Provide clear value propositions to third-party payers, such as managed care companies or government programs like Medicare, to merit reimbursement for our product candidates; and

    ●
    Collaborate with other pharmaceutical companies with respect to, among other things, our XPro, CORDStrom and INKmune product platforms.

Pursue development and
regulatory approval pathways. We believe INKmune and XPro may be approvable under pathways that are potentially shorter than those
typically available for drug products based on novel active ingredients, including as an orphan drug under the Orphan Drug Act and approval
under the Food and Drug Administration (the “FDA”) Accelerated Approval Program (see the section entitled “Government
Regulation”). We have not yet had a discussion with the United Kingdom Medicines and Healthcare Products Regulatory Agency (“MHRA”)
and/or FDA regarding such designation, but plan to do so in the future. We believe the INKmune program to treat castration resistant prostate
cancer may qualify for orphan status. We believe that it would take a minimum of six months to receive Orphan Drug status once we
apply for application and a minimum of 12 months to receive a designation once we submit an application. We might never have these discussions,
submit applications under the Orphan Drug Act or the FDA Accelerated Approval Program or have these applications approved if we do. We
have received Orphan Drug Designation (“ODD”) and Rare Pediatric Disease Designation (“RPDD”) for CORDStrom to
treat patients with epidermolysis bullosa (“EB”). We plan to file for Biologics License Application (“BLA”), an
approval document for full approval of CORDStrom with the FDA in late 2025 or early 2026. We also plan to file for Marketing Authorization
Application in the EU and United Kingdom in 2026 with CORDStrom for RDEB. Likewise, we plan to apply for an accelerated approval pathway
for the use of XPro to treat patients with AD in 202