Tiziana Life Sciences Begins Enrollment In Phase 2 Alzheimer's Trial Of Intranasal Foralumab, Plans First Dosing Next Week As New PET Data Shows Persistent Neuroinflammation Despite Leqembi Treatment

• First Patient Expected to be Dosed Next Week with Intranasal Foralumab
• PET Scan Shows Presence of Untreated Neuroinflammation in Alzheimer's Patient on Leqembi® (Lecanemab) Anti-Amyloid Therapy

BOSTON, Dec. 12, 2025 (GLOBE NEWSWIRE) -- 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, announces that enrolment has begun in its Phase 2 randomized, placebo-controlled early Alzheimer's clinical trial and plans to dose the first patient next week.

The Phase 2 clinical trial will evaluate intranasal foralumab both as monotherapy and in combination with an FDA approved anti-amyloid therapy, lecanemab or donanemab, in patients with early Alzheimer's disease (AD). Baseline clinical assessments, cognitive testing, TSPO-PET imaging, and fluid biomarkers have been completed in the first participants screened in the trial.

The clinical trial launch is supported by new TSPO-PET imaging evidence demonstrating persistent and widespread microglial activation in an Alzheimer's patient despite treatment with lecanemab, confirming that neuroinflammation remains present even after amyloid plaque reduction. Lecanemab, marketed by Eisai and Biogen as Leqembi®, is one of the two FDA-approved anti-amyloid therapies for treating early Alzheimer's and is proven to reduce beta-amyloid plaques.

• As a monotherapy, reduces microglial activation and slows cognitive decline by suppressing neuroinflammation.
• In combination with lecanemab or donanemab will provide additive or synergistic benefit by simultaneously targeting amyloid pathology and persistent microglial inflammation.