Announcement • May 02
Tiziana Life Sciences Ltd announced delayed 20-F filing On 04/30/2026, Tiziana Life Sciences Ltd announced that they will be unable to file their next 20-F by the deadline required by the SEC. New Risk • Apr 21
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2025. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Latest financial reports are more than 6 months old (reported June 2025 fiscal period end). Shareholders have been diluted in the past year (17% increase in shares outstanding). Announcement • Apr 18
Tiziana Life Sciences, Ltd. Announces Positive Data Demonstrating Intranasal Anti-CD3 Antibody Attenuates Long COVID Neuroinflammation and Improves Cognitive Function Tiziana Life Sciences Ltd. announced the publication of positive preclinical data in a bioRxiv preprint. The study, titled “Intranasal Anti-CD3 Antibody Treatment Attenuates Post COVID Neuroinflammation and Enhances Hippocampal Neurogenesis and Cognitive Function in Mice,” demonstrates that nasal anti-CD3 treatment significantly reduces neuroinflammation, boosts regulatory T cells (Tregs) in the brain, restores hippocampal neurogenesis, and improves short-term memory in a model of Long COVID. The study used a respiratory restricted mild SARS-CoV-2 mouse model that recapitulates key neurological features of Long COVID without direct brain infection. Nasal administration of anti-CD3 monoclonal antibody either shortly after infection or in the chronic phase increased brain FoxP3+ IL-10+ Tregs, reprogrammed microglia from a pro-inflammatory to a regulatory phenotype, reduced gliosis (astrocytes and microglia) in white matter and hippocampus, normalized CCL11 levels, restored neurogenesis, and rescued cognitive deficits. Human observational data in the study further showed that Long COVID patients with neurological symptoms exhibit lower circulating Treg levels, reinforcing the translational relevance. The full preprint is available on bioRxiv and has not yet been peer-reviewed. These findings show that nasal anti-CD3 can potently induce regulatory T cells that cross into the brain and dampen persistent neuroinflammation triggered by even mild respiratory viral infection. By reprogramming microglia, reducing harmful chemokines like CCL11, and restoring the hippocampal neurogenic niche, this approach offers a promising, non-invasive strategy to address the cognitive impairment often called ‘brain fog’ that continues to affect millions of Long COVID patients worldwide. Tiziana’s intranasal foralumab has previously demonstrated favorable safety and signals of clinical benefit in an expanded access program in non-active secondary progressive multiple sclerosis, with reductions in microglial activation observed via PET imaging. 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.