Company: INMB
Filing Date: 2025-05-08
Form Type: 10-Q
Source: 0001213900-25-041072
Chunk: 49

Company: Inmune Bio, Inc.
Filing Date: 2025-05-08
Form: 10-Q
Item: Part I, Item 2
Chunk 49
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 in many studies of patients with early AD. The AD
program is open in Australia, Canada, the United Kingdom, France, Germany, Spain, Czech Republic and Slovakia.

18

Full enrollment in the Phase
II AD trial occurred in late 2024 with 208 patients enrolled. Data is expected to be reported during June. After all the data is analyzed,
the Company plans an end-of-phase II meeting with the FDA to finalize plans for the pivotal Phase III trial. XPro for treatment of AD
may be eligible for one or both accelerated approval pathways. We expect to be eligible for Break Through status after completion of the
Phase II trial in 2025.

Effective therapy for
TRD is a large unmet need. Twenty percent of patients with a Major Depressive Disorder have TRD. Once third of TRD patients have
peripheral biomarkers to inflammation (elevated CRP). This is a large patient population. The role of TNF and anti-TNF therapeutics
was explored in a small open label clinical trial by Prof. Andrew Miller, MD of Emory University demonstrated the patients have
elevated TNF levels and treatment with infliximab treated their depression (Miller, 2011). The Company has a $2.0M USD award from
the National Institute of Mental Health (“NIMH”) to treat TRD with XPro. To date, these funds have not been impacted by
any changes at the NIH. The blinded, randomized Phase II trial will use biomarkers of peripheral inflammation to select patients
with TRD for enrollment. Patients will be treated for 6 weeks. Primary end-points include both clinical and neuroimaging measures.
The TRD trial is expected to start enrollment during 2025 once NIMH funds have been released.

CORDStrom,
developed by INmune Bio circa 2020, represents a breakthrough in mesenchymal stem cell technology. The CORDStrom platform leverages, among
other things, proprietary screening, pooling and expansion techniques to create off-the-shelf, allogeneic, pooled human umbilical cord
-derived mesenchymal stromal cells (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