Tiziana Life Sciences Begins Dosing Last Patient In Its Phase 2 Clinical Trial Evaluating Intranasal Foralumab In Patients With Early/Mild Alzheimer’s Disease; Topline Data Anticipated In Q1 2027

Tiziana Life Sciences, Ltd. (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced that the last patient has begun dosing in its Phase 2 randomized, placebo-controlled clinical trial evaluating intranasal foralumab in patients with early/mild Alzheimer’s disease (AD). Topline data are anticipated to be announced in Q1 2027.

This milestone completes enrollment and initiates dosing for all participants in the study, which is assessing the safety, tolerability, and potential efficacy of intranasal foralumab both as monotherapy and in combination with FDA-approved anti-amyloid therapies lecanemab (Leqembi®) or donanemab. The trial builds on evidence of persistent neuroinflammation (microglial activation) in Alzheimer’s patients, including those treated with anti-amyloid agents, as measured by TSPO-PET imaging. Key endpoints include changes in neuroinflammation via TSPO-PET imaging, cognitive function, and fluid biomarkers related to amyloid and tau pathology.