Recent Updates — TLSA
Tiziana Life Sciences reported a total comprehensive loss of $12.4 million for the six months ended June 30, 2026, compared to a $5.3 million loss in the prior year period. The company raised approximately $8.4 million net from the issuance of ordinary shares during the quarter. Cash and cash equivalents decreased to $3.2 million at June 30, with the balance falling further to $3.9 million by mid-October. Management disclosed a material uncertainty regarding its ability to continue as a going concern, citing significant cash outflows and the need to secure additional capital through equity raises or other measures to fund ongoing clinical trials for its lead asset, intranasal foralumab. The company is developing immunomodulation therapies for neurodegenerative and autoimmune diseases.
Tiziana Life Sciences completed enrollment and initiated dosing for all participants in its Phase 2 randomized, placebo-controlled clinical trial evaluating intranasal foralumab in patients with early or mild Alzheimer’s disease. The study assesses the safety, tolerability, and potential efficacy of the therapy as a monotherapy and in combination with FDA-approved anti-amyloid treatments lecanemab or donanemab. Topline data from the trial are anticipated to be announced in Q1 2027. Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies for immunomodulation.
On September 30, 2026, Tiziana Life Sciences Ltd submitted a request to the U.S. Food and Drug Administration for Orphan Drug Designation for intranasal foralumab to treat Multiple System Atrophy (MSA). MSA is a rare neurodegenerative disorder with no currently approved disease-modifying therapies. If granted, the designation would provide seven years of market exclusivity upon approval, tax credits for clinical testing, and fee waivers. The company is concurrently evaluating intranasal foralumab in a Phase 2a open-label clinical trial at Brigham and Women’s Hospital to assess effects on microglial activation and safety. Tiziana Life Sciences Ltd operates as a clinical-stage biopharmaceutical company developing immunomodulation therapies using alternative drug delivery technologies.
On September 28, 2026, Tiziana Life Sciences announced that the first three participants received their initial dose of intranasal foralumab in the Phase 2a Healey ALS MyMatch BANYAN clinical trial. The study evaluates the safety and tolerability of this anti-CD3 monoclonal antibody in 44 individuals with early-stage amyotrophic lateral sclerosis (ALS). Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing immunomodulation therapies.
Tiziana Life Sciences announced that the last patient completed their final visit in the Phase 2a INFORM-MS clinical trial evaluating intranasal foralumab for non-active Secondary Progressive Multiple Sclerosis. The randomized, double-blind study enrolled 48 patients across three cohorts to assess safety and efficacy over a 12-week period. The company expects to lock the database immediately and release topline data in October. Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing immunomodulation therapies using intranasal drug delivery technologies.