Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 13

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 13
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D Phase II trials. The
unfrozen drug product is being used in the ongoing AD02 AD trial. The remainder of the original fermentation runs is frozen as a cell
paste with a plan to process to drug substance. The company expects to convert the drug substance to drug product during 2025. Downstream
processing to drug product and fill/finish to drug product of the cell paste will occur in 2025 as needed to support the clinical trials.
We plan to use a two-step approach to improve the yield of the drug substance from the fermentation process. The Company is working on
the yield of the drug product using the existing E.coli-based system. A second program is focused on down-stream process improvements
in the drug manufacturing program. Once the new strain and process is validated and functional, we will perform a manufacturing campaign
drug for future clinical trials. In the future, the Company may consider a strain change to improve yield of the fermentation step further.
The decision for strain improvements and strain change will be made in the future as clinical development programs proceed.

Interaction with Regulatory Authorities Regarding
XPro Development

We have completed a Phase
I trial with DN-TNF in oncology. At this time we do not plan additional clinical trials with DN-TNF in oncology. A Phase II trial with
XPro in patients with Alzheimer’s disease is underway. Dosing of patients in the Phase II trial will complete in May 2025. The Phase
I trial with XPro in patients with Alzheimer’s disease was performed in Australia under the regulatory authority of the TGA using
the Clinical Trials Exemption (“CTX”) scheme. Our first interaction with the regulatory body occurred in March 2018. The Company
received approval to initiate the Phase I trial in patients with advanced solid tumors on May 21, 2018. The second interaction with
the regulatory body occurred in March 2019. The Company received approval to initiate the Phase I trial with XPro in patients with
Alzheimer’s disease in May 2019 and received authorization to start the Phase II trial in patients with mild AD on January 5, 2022.
Our first interaction with the FDA occurred in July 2020 as part of the Phase II Quellor program to treat respiratory failure in patients
hospitalized with COVID-19 infection. The newly manufactured XPro is being used to support the Phase II AD trial, the TRD Phase II trial
and the Expanded Access Scheme.

8

XPro Regulatory Strategy