INmune Bio, Inc. has received acceptance of a Clinical Trial Application (CTA) under EU Clinical Trials Regulation to initiate a Phase II trial in Early Alzheimer's Disease (AD) with XPro(TM) in Poland. Additional regulatory approval for the Phase II AD clinical trial is expected from at least two to potentially six more EU countries in the upcoming months. The EU approval is part of the Company's international clinical development strategy for XPro(TM) in patients with early AD.

The trial is currently enrolling patients in Australia, Canada, and the United Kingdom. The Phase II clinical trial is a global, multi-center, randomized clinical study in patients diagnosed with early Alzheimer's disease who have biomarkers of elevated inflammation. In a prior Phase I open-label trial, INmune Bio met all primary and secondary endpoints.

Patients with AD who received XPro(TM) demonstrated notable decreases in neuroinflammation, enhanced axonal integrity, and improved synaptic function. Employing advanced MRI imaging techniques enabling a "virtual biopsy" of the brain, treatment with XPro(TM) demonstrated improvements in the structural integrity of both gray and white matter in the brain. These funds provide a non-dilutive funding source, allowing INmune to reinvest in expanding recruitment and enrollment not only in Australia and Canada but also in newer locations in the U.K. and the EU.