Company: TLSA
Filing Date: 2025-03-24
Form Type: F-3
Source: 0001013762-25-001691
Chunk: 46

Company: Tiziana Life Sciences Ltd
Filing Date: 2025-03-24
Form: F-3
Chunk 46
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 expanded access program. The first 10 patients have all shown either an improvement or stability of disease within 6 months of starting treatment.

On February 21, 2025, we announced a product development services agreement with Renaissance Lakewood LLC (“Renaissance”), a leading Contract Development and Manufacturing Organization (CDMO) focused on nasal drug delivery. This collaboration aims to optimize the current formulation and develop a comprehensive plan for the scale-up of foralumab in a nasal device. Intranasal foralumab is currently under development for treating neurodegenerative and inflammatory diseases or conditions.

On February 25, 2025, we announced that a nasal anti-CD3 (foralumab) preclinical study is nearing completion, and that foralumab could offer a novel and effective treatment for long COVID. This innovative approach works by reducing microglial activation, a key factor in the persistent brain inflammation associated with long COVID, thereby addressing the debilitating neurological and psychiatric symptoms many patients face.

<div align='center'>S-3</div>

On February 27, 2025, we announced the publication of a landmark study in Nature Neuroscience demonstrating that nasal administration of our anti-CD3 monoclonal antibody significantly reduced neuroinflammation and improved recovery. Modulating the neuroinflammatory response correlated with improved neurological outcomes. These included, less anxiety, less cognitive decline, and improved motor skills, in a preclinical model of traumatic brain injury (TBI). On March 4, 2025, we announced the submission of our Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a phase 2 clinical trial in ALS. This pivotal step marks a significant advancement in our commitment to advance a new treatment approach for Amyotrophic Lateral Sclerosis (ALS) which is supported by the ALS Association. Risks Associated with Our Business Our business is subject to numerous risks. You should read these risks before you invest in our securities. In particular, our risks include, but are not limited to, the following:

| ● | We may fail to demonstrate                                                                                                         
 the safety and therapeutic utility of our product candidates to the satisfaction of applicable regulatory authorities, which would 
 prevent or delay regulatory approval and commercialization.                                                                        |

| ● | We depend on enrollment                                                                                                              
 of patients in our clinical trials for our product candidates and may find it difficult to enroll patients in our clinical trials,   
 which could delay or prevent us from proceeding with clinical trials of our product