Company: TLSA
Filing Date: 2025-03-24
Form Type: F-3
Source: 0001013762-25-001691
Chunk: 12

Company: Tiziana Life Sciences Ltd
Filing Date: 2025-03-24
Form: F-3
Chunk 12
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 brain inflammation associated with long COVID, thereby addressing the debilitating neurological and psychiatric symptoms many patients face. 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 candidates and could materially adversely affect 
 our research and development efforts and business, financial condition and results of operations.                                    |

| ● | We have incurred net losses                                                                                                             
 in every year since our inception. We anticipate that we will continue to incur losses for the foreseeable future and may never achieve 
 or maintain profitability.                                                                                                              |

| ● | We need substantial additional                                                                                                      
 funding to complete the development of our product candidates, which may not be available on acceptable terms, if at all. Failure   
 to obtain this necessary capital when needed may force us to delay, limit or terminate certain of our product development, research 
 operations or future commercialization efforts, if any.                                                                             |

| ● | We rely, and expect to                                                                                                                   
 continue to rely, on third parties to conduct our preclinical studies and clinical trials and for product manufacturing. If these        
 third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain