Announcement • Jun 15
Tiziana Life Sciences Ltd announced that it has received $0.01665 million in funding from Panetta Partners Limited Tiziana Life Sciences, Ltd. announced a private placement with Panetta Partners Ltd to issue 15,000 common shares at an issue price of $1.11 for the proceeds of $16,650 on June 15, 2026. Announcement • May 23
Tiziana Life Sciences Fully Enrolls Phase 2 Placebo Controlled Multiple Sclerosis Trial Tiziana Life Sciences Ltd. announced that patient enrollment has been completed in its randomized, double-blind, placebo-controlled Phase 2a clinical trial evaluating intranasal foralumab in patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS). Topline data is expected in late Third Quarter of 2026, and will also to be presented at the 10th joint Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and ECTRIMS meeting in Toronto, Canada in October 2026. The trial (NCT06292923), known as INFORM-MS, is the first Phase 2 placebo-controlled study of intranasal foralumab, marking a significant milestone in the clinical development of this novel anti-CD3 monoclonal antibody for neurodegenerative and neuroinflammatory diseases. The multicenter study has enrolled 48 patients across multiple U.S. sites to receive one of two doses of intranasal foralumab or placebo over a 12-week treatment period, with assessments including PET imaging for microglial activation, MRI, clinical evaluations, and biomarkers. Following the completion of the blinded phase, all participants including those who initially received placebo will have the opportunity to receive intranasal foralumab during a six-month open label extension (OLE) phase. The OLE is designed to assess long term safety and sustained benefit of foralumab in the na-SPMS patient population. Foralumab, a fully human anti-CD3 monoclonal antibody, is a biologic candidate that has been shown to stimulate T regulatory cells when dosed intranasally. Currently, 14 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923). Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases. Announcement • May 20
Tiziana Life Sciences Ltd Announces New Positive Clinical Data For Intranasal Foralumab In Non-Active Secondary Progressive Multiple Sclerosis Tiziana Life Sciences Ltd. announced updated clinical data from its ongoing Expanded Access Program evaluating intranasal foralumab in 14 patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS). The data, updated from March 2025 to as of March 2026, demonstrate that intranasal foralumab continues to be extremely well tolerated over extended treatment durations. Patients showed encouraging trends in stabilization of disability as measured by the Expanded Disability Status Scale (EDSS) and meaningful improvements in fatigue as measured by the Modified Fatigue Impact Scale (MFIS). Foralumab was well tolerated with no new safety signals identified. We observed a favorable trend toward disease stabilization (i.e., reduced Confirmed Disability Progression (CDP)). 64% of patients achieved a clinically meaningful improvement of =4 points in their MFIS score. The graph titled "Foralumab Expanded Access Program vs Hercules Reference Arms" compares the cumulative incidence of disability progression events in the foralumab EA cohort against the placebo and tolebrutinib arms from the Phase 3 HERCULES non-relapsing SPMS trial. The foralumab line shows only a single event, indicating strong stabilization in the majority of treated patients. An "event" is defined per the Sanofi NEJM publication as a sustained increase in EDSS of =1.0 point if baseline EDSS About Foralumab. Foralumab, a fully human anti-CD3 monoclonal antibody, is a biologic candidate that has been shown to stimulate T regulatory cells when dosed intranasally. Currently, 14 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access Program (NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923). Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases. 
