Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 40

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 40
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 in combination
with a TKI and/or CPI. Current therapies for TDxd resistant cancers are used on a trial by error approach. Using MUC4 expression as a
biomarker for to predict resistance may bring a precision medicine approach to this difficult clinical scenario. Addition of INB03 to
the treatment regimen for treating MUC4+ cancers may convert “cold” tumors to “hot” tumors making the eligible
for treatment with CPI. The design and successful completion of a Phase II trial is not guarantee of clinical relevance or commercial
viability. There are multiple therapies on the market or in development for the treatment of resistant breast cancer. The introduction
of TDxd to the clinician’s armamentarium is new and evolving. The future standard-of-care is not known. The registration and development
strategy for INB03 is multinational. The Phase II program may enroll patients in other countries, including the United States after submitting
an Investigational New Drug application, or IND, to the U.S. Food and Drug Administration, or FDA. If partnering is successful at any
stage of INB03 development, we expect the partner to influence the development and regulatory decisions needed with moving the drug to
commercialization. Finally, combination therapy to treat patients resistant to trastuzumab or CPI are not the only oncology application
for INB03. INB03 can be combined with other immune-oncology therapy to improve efficacy, safety or both. INB03 can be used as part of
combination therapy with immuno-oncology drugs, paired with tradition therapies such as cytotoxic chemotherapy, kinase inhibitors, cell
therapies or radiation therapy. The company is pursuing pre-clinical data in some of these areas. When and if positive developments occur,
we will communicate them to our shareholders. There are other regulatory venues that will be important for both our products – the
largest and most important is Europe. In Europe, the European Medicines Agencies (“EMA”) is responsible for authorization
of clinical trials in member states. In EU, there may be a requirement to get individual country authorization at the same time as EMA
authorization. The initial development of INB03 and XPro occurred in AUS followed by trials in other regulatory jurisdictions including
the US. The development of INKmune will start in the United Kingdom followed by trials in the US. XPro is being developed for the treatment
of Alzheimer’s disease under a Part-the-Cloud Award received Feb 2019.