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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 (Nasdaq: TLSA) has fully enrolled 48 patients in INFORM-MS, its randomized, double-blind, placebo-controlled Phase 2a trial of intranasal foralumab in non-active secondary progressive multiple sclerosis.
The 12-week study includes PET, MRI and biomarker assessments, followed by a six-month open-label extension. Topline data are expected in late Q3 2026 and will be presented at ACTRIMS/ECTRIMS in October 2026.
Tiziana (Nasdaq: TLSA) reported updated clinical data from its Expanded Access Program of intranasal foralumab in 14 patients with non-active secondary progressive multiple sclerosis as of March 2026.
Foralumab remained well tolerated, with trends toward disability stabilization on EDSS and 64% of patients achieving clinically meaningful fatigue improvement on MFIS (≥4-point reduction), though results are not statistically significant.
Tiziana Life Sciences (Nasdaq: TLSA) reported initial Phase 2 PET imaging data for intranasal foralumab in Multiple System Atrophy (MSA).
In the first two MSA patients, PET scans showed up to ~35% reduction in SUV and ~24% reduction in SUVR in disease-relevant brain regions, suggesting reduced neuroinflammatory activity.
This is the third indication with observed PET inflammation reduction for intranasal foralumab, following non-active secondary progressive multiple sclerosis and moderate Alzheimer’s disease.
Tiziana Life Sciences (NASDAQ: TLSA) announced publication (April 16, 2026) of positive preclinical data on intranasal foralumab in a bioRxiv preprint. The mouse study showed reduced neuroinflammation, increased brain FoxP3+ IL-10+ Tregs, restored hippocampal neurogenesis, and improved short-term memory. Human observational data linked Long COVID neurological symptoms to lower circulating Tregs. The preprint is not yet peer-reviewed.
Tiziana Life Sciences (Nasdaq: TLSA) announced a late-breaking poster acceptance for its Phase 2a TILS-025 study of intranasal foralumab in Multiple System Atrophy (MSA) at the 7th World Parkinson Congress, May 24-27, 2026 in Phoenix.
The poster describes the open-label trial (NCT06868628) enrolling up to 10 MSA patients to assess microglial activation by TSPO PET and clinical scores over six months.
Tiziana Life Sciences (Nasdaq: TLSA) announced preclinical data showing intranasal anti-CD3 (foralumab) reversed key aspects of brain aging and improved cognition in an aging model.
Findings report reduced microglial activation, enhanced hippocampal neurogenesis, and lowered cellular senescence markers, supporting further clinical development in neurodegenerative indications.
Tiziana Life Sciences (Nasdaq: TLSA) reported biomarker results showing intranasal foralumab reduced PET-measured microglial activation and shifted CSF proteomics toward decreased inflammation and increased neuroprotection in na-SPMS patients with PIRA.
Findings from 10 patients (14 paired evaluations) showed significant PET m-GALP z-score reductions (p<0.05 at 3 months+), strong correlations between PET and CSF proteins (r up to 0.896 and -0.931, p<0.05), clinical stabilization/improvement, and no serious treatment-related adverse events. Phase 2a top-line data expected H1 2026.
Tiziana Life Sciences (Nasdaq: TLSA) announced peer-reviewed publication of an open-label study of intranasal foralumab in non-active secondary progressive multiple sclerosis (na-SPMS) in Neurology Neuroimmunology & Neuroinflammation on Jan 20, 2026. The 10-patient study reported no serious treatment-related adverse events, stabilization of EDSS in all patients with improvement in 3 of 4 treated 12 months, MFIS fatigue improvement in 6 of 10, no new T2 MRI lesions, reduced microglial activation by TSPO-PET (p<0.05), and single-cell RNA-seq showing increased Tregs and TGFβ. A randomized double-blind Phase 2 in na-SPMS is ongoing with top-line data expected in 1H 2026.
Tiziana Life Sciences (Nasdaq: TLSA) closed an oversubscribed registered direct offering of 7,040,000 ordinary shares at $1.25 per share, raising gross proceeds of approximately $8.8 million. Each share issued includes a warrant exercisable at $1.50 through July 16, 2026, which could yield up to ~$10.56 million in additional gross proceeds if fully exercised.
The offering was conducted without an underwriter and was subscribed by senior management and existing shareholders, including CEO Ivor Elrifi who bought 2,400,000 shares and increased his total to 2,757,848 shares, and Executive Chairman Gabriele Cerrone who bought 1,600,000 shares raising his total to 44,974,830 shares. Proceeds are intended to complete Phase 2 na-SPMS and MSA trials and deliver topline data readouts.
Tiziana Life Sciences (Nasdaq: TLSA) priced a registered direct offering of 6,400,000 ordinary shares at $1.25 per share, expected to raise approximately $8.0 million in gross proceeds before expenses. Each share purchased includes a warrant to buy one ordinary share at $1.50 exercisable through July 16, 2026, potentially generating up to an additional $9.6 million. The Offering, conducted without an underwriter and expected to close on January 16, 2026, was led by CEO Ivor Elrifi and included a purchase by Executive Chairman Gabriele Cerrone. Proceeds are intended to fund completion of the company’s Phase 2 na-SPMS and MSA clinical trials and topline data readouts.