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Tiziana Life Sciences Ltd. develops intranasal foralumab, a fully human anti-CD3 monoclonal antibody, as a clinical-stage biotechnology company focused on neuroinflammatory and neurodegenerative diseases. News for TLSA centers on clinical and preclinical data for intranasal anti-CD3 therapy, including non-active secondary progressive multiple sclerosis, Multiple System Atrophy, Alzheimer’s disease, ALS, Long COVID-associated neuroinflammation, and age-related cognitive decline.
Company updates also cover biomarker work involving CSF proteomics, TSPO-PET and microglial activation, peer-reviewed publications, scientific conference presentations, expanded-access observations, and financing actions such as registered direct offerings of ordinary shares and warrants.
Tiziana Life Sciences (TLSA) reports that the last patient has completed the last visit in its Phase 2a INFORM-MS trial of intranasal foralumab in non-active Secondary Progressive Multiple Sclerosis (na-SPMS).
The randomized, double-blind, placebo-controlled study enrolled 48 patients across three cohorts at multiple U.S. sites and evaluates two intranasal foralumab doses versus placebo over 12 weeks. The primary endpoint is change in microglial activation by PET imaging, with secondary clinical measures including EDSS and MFIS. Tiziana plans to lock the database this week and announce 12-week topline data in October. After the blinded phase, all participants may receive intranasal foralumab in a six-month open-label extension to gather longer term safety and efficacy data. Separately, an Expanded Access Program in na-SPMS has treated 14 patients, all of whom showed disease stability or improvement within six months.
Tiziana Life Sciences (TLSA) signed a Memorandum of Understanding with King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, and the Foundation for Neurologic Diseases on September 16, 2026.
The parties intend to collaborate on a clinical trial combining Tiziana’s intranasal foralumab with existing anti-CD20 therapy in relapsing-remitting multiple sclerosis patients who respond poorly to anti-CD20 alone. Intranasal foralumab has reduced neuroinflammation in three clinical studies, and a Phase 2 trial in non-active secondary progressive MS remains blinded with results expected in October this year.
Tiziana Life Sciences (Nasdaq: TLSA) announced that Dr. Pinar Uysal will present a poster titled “Phase 2a Trial of Intranasal Foralumab – BANYAN, a Healey ALS MyMatch Trial” at ALS Nexus 2026 on August 24, 2026, in Orlando, Florida. The presentation will outline the BANYAN Phase 2a randomized, placebo-controlled, multicenter trial (3:1 foralumab:placebo) of intranasal foralumab in people living with ALS, including preclinical support, study design, and use of the ALS MyMatch Common Screening Protocol.
The BANYAN study, conducted across NEALS sites within the Healey ALS MyMatch infrastructure and supported by the ALS Association and foundations, is designed to assess safety, immune and neuroinflammation biomarkers, and early clinical signals. The trial is in its operational startup phase, with enrollment timing and site details to be announced. Tiziana highlights intranasal foralumab’s mechanism of expanding regulatory T cells to modulate neuroinflammation, and notes ongoing development in non-active secondary progressive multiple sclerosis, including an Expanded Access program and a separate Phase 2a dose-ranging trial.
Tiziana Life Sciences (Nasdaq: TLSA) reported that Chief Executive Officer Ivor Elrifi purchased 321,423 common shares on Nasdaq at $1.00 per share, increasing his total holding to 4,793,684 shares. The company focuses on immunomodulation therapies using its lead candidate, intranasal foralumab, a fully human anti-CD3 monoclonal antibody.
According to Tiziana Life Sciences, 14 patients with non-active secondary progressive multiple sclerosis (na-SPMS) have been dosed in an open-label, intermediate-size Expanded Access Program, with improvement or disease stability observed within six months in all patients. Intranasal foralumab is also being evaluated in a Phase 2a randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in na-SPMS. The company states that foralumab is currently the only fully human anti-CD3 mAb in clinical development and has shown a favorable safety profile and clinical response in studies to date.
Tiziana Life Sciences (Nasdaq: TLSA) announced that Chief Executive Officer Ivor Elrifi purchased 667,000 common shares on Nasdaq at $1.00 per share, increasing his total holding to 4,472,261 shares. The company highlights its lead candidate, intranasal foralumab, a fully human anti-CD3 monoclonal antibody being developed for immunomodulation.
According to Tiziana Life Sciences, 14 patients with non-active secondary progressive multiple sclerosis (na-SPMS) have been dosed with intranasal foralumab in an open-label expanded access program, with improvement or stability of disease observed within six months in all patients. Intranasal foralumab is also being evaluated in a Phase 2a randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in na-SPMS. The company states that foralumab is currently the only fully human anti-CD3 mAb in clinical development and that its intranasal delivery platform has shown a favorable safety profile and clinical responses to date.
Tiziana Life Sciences (Nasdaq: TLSA) reported quantitative PET imaging results from the third Multiple System Atrophy (MSA) patient to complete dosing in its Phase 2 trial of intranasal foralumab. PET analysis showed up to a 34% reduction in standardized uptake value (SUV) and 26% reduction in standardized uptake value ratio (SUVR) in disease-relevant brain regions, including the basal ganglia and cerebellar white matter.
According to Tiziana, these reductions are similar to those seen in the first two MSA patients, who demonstrated up to approximately 35% SUV and 24% SUVR reductions, supporting PET imaging evidence of biological activity in dampening neuroinflammation. The company plans to treat additional MSA patients and continues parallel development of intranasal foralumab in non-active secondary progressive multiple sclerosis through an expanded access program and a Phase 2a randomized trial.
Tiziana Life Sciences (Nasdaq: TLSA) reported that Executive Chairman and Founder Gabriele Cerrone, via Panetta Partners, purchased 42,357 common shares at $0.99 per share. This increases his holding to 44,814,587 shares, representing 34.93% of the company’s issued share capital.
The company’s lead candidate, intranasal foralumab, a fully human anti-CD3 monoclonal antibody, is being developed for immunomodulation. According to Tiziana Life Sciences, 14 patients with non-active secondary progressive multiple sclerosis in an expanded access program showed disease improvement or stability within six months. Intranasal foralumab is also being evaluated in a Phase 2a randomized, double-blind, placebo-controlled, dose-ranging trial, and is described by the company as the only fully human anti-CD3 mAb currently in clinical development.
Tiziana (Nasdaq: TLSA) reported that the last patient in its Phase 2a INFORM-MS trial of intranasal foralumab for non-active secondary progressive multiple sclerosis has received a first dose. The randomized, double-blind, placebo-controlled study will enroll up to 48 patients across multiple U.S. sites, with topline data expected in late Q3/early Q4 2026 and a planned presentation at ACTRIMS/ECTRIMS in October 2026.
Tiziana Life Sciences (Nasdaq: TLSA) reported that Executive Chairman and founder Gabriele Cerrone, via Panetta Partners, purchased 15,000 common shares at $1.11 per share. This transaction increased his total holding to 44,772,230 shares, representing 34.89% of Tiziana's issued share capital.
Tiziana Life Sciences (Nasdaq: TLSA) will present at the Jefferies Global Healthcare Conference in New York City.
CEO Ivor Elrifi and COO/CFO Keeren Shah will give a corporate presentation on June 4, 2026, from 10:30–11:00 AM ET, covering recent clinical and corporate updates, followed by a Q&A with institutional investors.