foralumab nasal (TZLS-401 nasal) / Tiziana Life Sci, LightChain Bioscience - LARVOL DELTA

Tiziana Life Sciences…announced that the last patient has completed their last visit in the Company’s Phase 2a clinical trial evaluating intranasal foralumab in patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS) (GlobeNewswire) - "The randomized, double-blind, placebo-controlled Phase 2a trial, known as INFORM-MS (NCT06292923), enrolled a total of 48 patients across three cohorts at multiple leading U.S. clinical sites....Tiziana expects to lock the database this week, and announce 12-week treatment topline data in October."

P2a data • Trial status • Multiple Sclerosis

Tiziana Life Sciences Announces Signing of MOU with King Abdullah International Medical Research Center (The Manila Times) - "...the parties intend to collaborate on a clinical trial evaluating a combination of Tiziana’s proprietary intranasal foralumab and existing anti-CD20 therapy in patients with relapsing-remitting multiple sclerosis (RRMS) who are responding poorly to anti-CD20 therapy alone, which could be due to untreated neuroinflammation. In three clinical studies to date, intranasal foralumab has been shown to reduce neuroinflammation."

Licensing / partnership • New trial • Immunology • Multiple Sclerosis

Tiziana Life Sciences Announces Poster Presentation on Phase 2a BANYAN Clinical Trial of Intranasal Foralumab at ALS Nexus 2026 (The Manila Times) - "Dr. Uysal’s presentation will provide an overview of the BANYAN Trial within the Healey ALS MyMatch program at the Sean M. Healey & AMG Center for ALS at Mass General Brigham. It will cover preclinical data supporting foralumab in ALS, the study design, and the implementation of the ALS MyMatch Common Screening Protocol...The trial is currently in its operational start up phase, further information regarding enrollment timing and site locations will be provided in a forthcoming press release."

Clinical protocol • Preclinical • Trial status • Amyotrophic Lateral Sclerosis

Tiziana Reports Reduction in Brain Inflammation in Third Multiple System Atrophy Patient Treated with Intranasal Foralumab (GlobeNewswire) - "Quantitative analysis of PET scans demonstrated reductions in inflammatory activity in clinically relevant brain regions known to be affected in MSA following treatment with intranasal foralumab. The third MSA patient to complete dosing has shown up to 34% reduction in standardized uptake value (SUV) and 26% reduction in standardized uptake value ratio (SUVR) in the most affected areas relevant to MSA (basal ganglia and cerebellar white matter) in the brain. These findings are similar to the first two MSA patients, who showed up to approximately 35% reduction in standardized uptake value (SUV) and 24% reduction in standardized uptake value ratio (SUVR)....Tiziana plans to continue evaluating intranasal foralumab in additional patients to further validate these findings and better characterize the therapy’s potential to reduce neuroinflammation in MSA."

P2 data • Multiple System Atrophy

The BANYAN Trial, an ALS MyMatch Trial Evaluating Safety, Biomarker Activity, and Microglial Activation of Nasal Foralumab (clinicaltrials.gov) - P2 | N=44 | Not yet recruiting | Sponsor: Tiziana Life Sciences LTD

Biomarker • New P2 trial • Amyotrophic Lateral Sclerosis • CNS Disorders

A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients (clinicaltrials.gov) - P2 | N=54 | Active, not recruiting | Sponsor: Tiziana Life Sciences LTD | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2025 ➔ Oct 2026 | Trial primary completion date: Nov 2025 ➔ Sep 2026

Enrollment closed • Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis

Nasal Foralumab Ameliorates Neuroinflammation in Secondary Progressive Multiple Sclerosis by Inducing Transcriptional Reprogramming in T Cells (FOCIS 2026) - "Notably, increased TGFB1 expression was observed in both CSF and PBMCs, suggesting a regulatory and immunomodulatory effect of the therapy. We identified accessible biomarkers distinguishing SP patients and proteins linked to disease progression and found that nasal Foralumab ameliorates MS by increasing TGFB1 and suppressing T cell cytotoxicity and inflammation."

IO biomarker • Fibrosis • Immunology • Inflammation • Multiple Sclerosis • CD4 • CD8 • COL8A1 • IFNAR1 • LAMP1 • SIGLEC14 • TGFB1

A phase 2a study of foralumab nasal in multiple system atrophy (WPC 2026) - P2 | "Conclusion This Phase 2a trial provides the first longitudinal assessment of intranasal anti CD3 therapy in MSA. By integrating imaging, biomarker, and clinical outcomes, the study is designed to examine whether intranasal foralumab reduces microglial activation, stabilizes or improves clinical symptoms, and modulates inflammatory biomarkers."

Late-breaking abstract • P2a data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Inflammation • Movement Disorders • Multiple Sclerosis • Multiple System Atrophy • Parkinson's Disease

Tiziana Life Sciences…announces 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) (GlobeNewswire) - "Topline data is expected in late Q3 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 leading U.S. sites."

Enrollment closed • P2a data • Multiple Sclerosis

Tiziana Life Sciences…announces updated clinical data from its ongoing Expanded Access ('EA') Program evaluating intranasal foralumab in 14 patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS) (GlobeNewswire) - "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)....EDSS Stabilization: We observed a favorable trend toward disease stabilization (i.e., reduced Confirmed Disability Progression (CDP)). Fatigue Improvement: 64% of patients achieved a clinically meaningful improvement of ≥4 points in their MFIS score."

Clinical data • Multiple Sclerosis

Tiziana Reports Reduced Brain Inflammation in Multiple System Atrophy Patients Treated with Intranasal Foralumab (Tiziana Life Sciences Press Release) - "Quantitative analysis of PET scans demonstrated reductions in inflammatory activity in clinically relevant brain regions known to be affected in MSA following treatment with intranasal foralumab. In the first two treated patients, investigators observed up to approximately 35% reduction in standardized uptake value (SUV) and approximately 24% reduction in standardized uptake value ratio (SUVR) in affected areas of the brain...The reductions were observed in regions including the basal ganglia and cerebellar white matter, which are known to be involved in the neurodegenerative processes underlying MSA....Tiziana plans to continue evaluating intranasal foralumab in additional patients to further validate these early findings and better characterize the therapy’s potential to reduce neuroinflammation in MSA."

P2 data • Multiple System Atrophy

Integrated multiomics profiling reveals MS-specific molecular signatures linked to progression and response to nasal anti-CD3 (Foralumab) therapy (IMMUNOLOGY 2026) - "We identified accessible biomarkers distinguishing RR and SP patients and proteins linked to disease progression and found that nasal Foralumab ameliorates MS by increasing TGFB1 and suppressing T cell cytotoxicity and inflammation."

IO biomarker • CNS Disorders • Fibrosis • Immunology • Inflammation • Multiple Sclerosis • COL8A1 • IFNAR1 • LAMP1 • PTPRC • SIGLEC14 • TGFB1

Tiziana Life Sciences Announces Late Breaking Poster Accepted for Presentation at the 7th World Parkinson Congress (GlobeNewswire) - "This Phase 2a, open-label trial is enrolling up to 10 subjects...Primary endpoints include changes in microglial activation measured by [F-18]PBR06 TSPO PET imaging and changes in MDS-UMSARS scores. Secondary endpoints encompass regional brain atrophy on volumetric MRI, autonomic function, quality-of-life measures, and immune biomarkers in blood and CSF."

Late-breaking abstract • P2a data • Multiple System Atrophy

NASAL IMMUNOTHERAPY WITH PROTOLLIN AND FORALUMAB MODULATE PERIPHERAL CELLULAR IMMUNITY TO CLEAR AMYLOID AND DAMPEN MICROGLIAL ACTIVATION IN ALZHEIMER'S DISEASE (ADPD 2026) - "We initiated clinical trials in AD to modulate peripheral immunity by targeting monocytes and Tregs to clear brain amyloid and decrease microglial activation. In placebo-controlled studies, we treated early AD with 1) nasal Protollin, a proteasome-based adjuvant that in AD models activates monocytes to clear Abeta and improve cognition and 2) nasal foralumab, a humanized anti-CD3 Mab, that in AD models induces Tregs that decreases microglial activation and improves cognition in an amyloid-independent fashion. Nasal Protollin and foralumab had positive immunologic and clinical effects in AD and are novel immunotherapies to target monocytes and Tregs. Foralumab could be a treatment for ARIA. Phase 2 placebo-controlled trials of nasal Protollin and foralumab in early AD are being undertaken."

IO biomarker • Alzheimer's Disease • CNS Disorders • Hematological Disorders • CD36 • CD4 • CD8 • FCGR1A • FOXP3 • IL2RA • ITGAL • SCARB1

Tiziana is advancing intranasal foralumab in an ongoing randomized, double-blind, placebo-controlled Phase 2a trial (NCT06292923) in na-SPMS, with top-line data expected in the first half of 2026. (The Manila Times)

P2a data • Multiple Sclerosis

Tiziana Life Sciences Announces New Biomarker Data Showing Nasal Foralumab Downregulates CSF Inflammation, Upregulates Neuroprotective Pathways, and Correlates with Reduced Microglial Activation on PET Scans in na-SPMS Patients with PIRA (The Manila Times) - "Nasal foralumab treatment significantly reduced voxel-wise average [F-18]PBR06-PET m-GALP z-scores in white matter and global brain regions; CSF proteomics showed downregulation of inflammatory biomarkers (e.g., IFNAR1 in the interferon pathway and LY86 in the NF-κB pathway) and upregulation of neuroprotective proteins (e.g., MEG10); Strong positive correlations were observed between PET m-GALP z-scores and inflammatory CSF proteins (e.g., IFNAR1 in high-affinity TSPO binders across whole brain, cortex, and cerebellum; r values up to 0.896, p; These biomarker changes occurred alongside clinical stabilization or improvement, with no serious treatment-related adverse events."

Biomarker • Clinical data • Multiple Sclerosis

Nasal foralumab downregulates CSF inflammation and upregulates CSF neuroprotective proteomic pathways which correlate with [F-18]PBR06-PET imaging in na-SPMS with PIRA (ACTRIMS Forum 2026) - "Nasal foralumab reduces inflammatory CSF biomarkers and microglial PET signal and increases CSF markers of neuroprotection. We found that [F-18]PBR06-PET positively correlates with CSF inflammatory proteins and negatively correlates with CSF neuroprotective proteins in na-SPMS with PIRA. This demonstrates that microglia PET is linked to the biologic processes that drive SPMS and that CSF proteomics can be used to measure response to therapy in SPMS."

Fibrosis • Immunology • Inflammation • Multiple Sclerosis • IFNAR1

Tiziana Life Sciences Announces Closing of Oversubscribed $8.8 Million Registered Direct Offering of Ordinary Shares (Tiziana Life Sciences Press Release) - "The proceeds from this offering enable the company to complete its Phase 2 na-SPMS and MSA clinical trials, and achieve top line data readouts in both trials."

Financing • Multiple Sclerosis

Tiziana Life Sciences to Present at the 9th Annual Neuroscience Innovation Forum During J.P. Morgan Healthcare Conference Week in San Francisco (The Manila Times) - "The 9th Annual Neuroscience Innovation Forum is a premier industry event featuring keynotes, panel discussions, and company presentations focused on advances in therapeutics, neurotechnology, and diagnostics for neurological disorders. Tiziana's presentation will highlight the Company's lead candidate, intranasal foralumab, a fully human anti-CD3 monoclonal antibody designed to modulate the immune system and reduce microglial activation in neurodegenerative conditions."

Clinical • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • Multiple Sclerosis • Multiple System Atrophy

Tiziana Files Annual Safety Report for Intranasal Foralumab with FDA (The Manila Times) - "This DSUR (September 21, 2024, to September 2, 2025), reports no drug-related serious adverse events after a cumulative exposure of 37.4 patient-years, highlighting the safety and tolerability data profile of intranasal foralumab in treating neuroinflammatory diseases, including non-active secondary progressive multiple sclerosis (naSPMS), multiple system atrophy and Alzheimer’s Disease (AD)...'Our Phase 2 foralumab trial in naSPMS will read out in 2026.'...Key highlights from the submission include...Fourteen naSPMS patients received nasal foralumab at 50 micrograms per dose (6 days per three-week cycle) for durations from 23 weeks to 3.5 years, contributing 30.7 patient-years of exposure; TILS-021 Randomized Trial and TILS-022 Open-Label Extension....Single-Patient Expanded Access for AD (IND 172400)."

Clinical • P2a data • Alzheimer's Disease • Multiple Sclerosis • Multiple System Atrophy

Tiziana Life Sciences Doses First Patient in Phase 2 Alzheimer’s Clinical Trial (GlobeNewswire) - "The Phase 2 trial evaluates intranasal foralumab both as monotherapy and in combination with FDA-approved anti-amyloid therapies, lecanemab (Leqembi) or donanemab, in patients with early AD."

Trial status • Alzheimer's Disease

Tiziana Life Sciences…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 (GlobeNewswire) - "The Phase 2 study is designed to evaluate the safety, tolerability, and efficacy of intranasal foralumab as both a monotherapy and in combination with lecanemab or donanemab in early/mild AD. Key endpoints will include measures of neuroinflammation (via TSPO-PET imaging), cognitive function, and biomarker changes related to amyloid and tau pathology."

Trial status • Alzheimer's Disease

Tiziana Life Sciences Nasal Foralumab Phase 2 Clinical Trial Accepted into Healey ALS MyMatch Program (GlobeNewswire) - "The trial will enroll at multiple rapid-enrolling U.S. centers within the Network of Excellence for ALS (NEALS) Consortium. Successful investigational products from the Healey ALS MyMatch program may advance to future regimens of the HEALEY ALS Platform Trial – a perpetual, multi-regimen, late-phase clinical efficacy study – or transition directly to standalone Phase 3 trials."

New P2 trial • Amyotrophic Lateral Sclerosis

Tiziana Life Sciences to Present at BIO-Europe in Vienna, Highlighting Innovative Immunomodulation Therapy (GlobeNewswire) - "The Company’s presentation will focus on its innovative nasal delivery platform and lead candidate, intranasal foralumab—the only fully human anti-CD3 monoclonal antibody in clinical development. This proprietary approach aims to enhance efficacy, safety, and tolerability over traditional intravenous methods, targeting neuroinflammatory and neurodegenerative diseases such as non-active secondary progressive multiple sclerosis (na-SPMS), Multiple System Atrophy (MSA), and early Alzheimer’s disease."

Clinical • Alzheimer's Disease • Multiple Sclerosis • Multiple System Atrophy

INFORM-MS: Study design of a Phase 2a double blind placebo-controlled trial of nasal foralumab in non-active secondary progressive multiple sclerosis (ECTRIMS 2025) - P1, P2 | "Nasal foralumab is being investigated in non-active SPMS in this multicenter phase 2a trial, which includes TSPO-PET scan as a primary outcome measure."

Clinical • P2a data • CNS Disorders • Inflammation • Multiple Sclerosis