INmune Bio Inc. is on track to complete enrollment of its Phase II clinical trial in patients with early Alzheimer's Disease and biomarkers of inflammation in 2024. The
Company received notification by the FDA that the US Phase II trial remains on full clinical hold pending a request for additional information on long-term potency. The request came following the most recent submission to the FDA that showed a possible increase in the long-term potency of XPro(TM) . The Company will provide clarification to the FDA in a response before the end of the year that it believes will resolve the remaining questions. The trial is open in Australia, Canada, the United Kingdom, Poland, France, Spain and is expected to open soon in several additional EU countries. To date, the FDA remains the only regulatory agency to put the Phase II clinical trial on hold.