About this content About Angela Harmantas Angela Harmantas is an Editor at Proactive. She has over 15 years of experience covering the equity markets in North America, with a particular focus on junior resource stocks. Angela has reported from numerous countries around the world, including Canada, the US, Australia, Brazil, Ghana, and South Africa for leading trade publications. Previously, she worked in investor relations and led the foreign direct investment program in Canada for the Swedish government ...

BOSTON, Jan. 20, 2026 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana”), a biotechnology company developing its lead candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, announces the peer-reviewed publication of its open-label study in patients with non-active secondary progressive multiple sclerosis (na-SPMS) in Neurology Neuroimmunology & Neuroinflammation, a prestigious journal of the American Academy of Neurology. The publication, titled “Nasal Foraluma ...

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company operates with a team of experienced and qualified news journalists across key finance and investing hubs including London, New York, Toronto, Vancouver, Sydney, and Perth [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The content delivered by the team includes insights across various sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Utilization - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company employs automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans to maintain best practices in content production and search engine optimization [5]

Core Viewpoint - Tiziana Life Sciences has successfully closed a registered direct offering of 7,040,000 ordinary shares at $1.25 per share, raising gross proceeds of $8.8 million, which will support its clinical trials for intranasal foralumab, its lead candidate [1][3]. Group 1: Offering Details - The offering was conducted without an underwriter or placement agent and was primarily subscribed by senior management and existing shareholders [1]. - Participants in the offering will receive warrants to purchase additional shares at $1.50, potentially raising an additional $10.56 million [1]. - The offering was led by CEO Ivor Elrifi, who purchased 2,400,000 shares, increasing his total holdings to 2,757,848 shares [2]. Group 2: Clinical Development - Proceeds from the offering will enable Tiziana to complete Phase 2 clinical trials for non-active secondary progressive multiple sclerosis (na-SPMS) and multiple system atrophy (MSA) [3]. - Foralumab, the lead candidate, is a fully human anti-CD3 monoclonal antibody that has shown promise in stimulating T regulatory cells when administered intranasally [6][7]. - The drug is currently being tested in a Phase 2a trial, with positive early results reported in an open-label program involving 14 patients [6]. Group 3: Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies [8]. - The company's nasal delivery approach aims to enhance the efficacy, safety, and tolerability of immunotherapy compared to traditional intravenous methods [8]. - Tiziana's technology for alternative routes of immunotherapy is patented, with several applications pending, indicating potential for a broad pipeline of therapies [8].

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company operates with a team of experienced and qualified news journalists across key finance and investing hubs including London, New York, Toronto, Vancouver, Sydney, and Perth [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The content delivered by the company includes insights across various sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Utilization - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company employs automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans to maintain best practices in content production and search engine optimization [5]

Core Viewpoint - Tiziana Life Sciences, Ltd. has announced a registered direct offering of 6,400,000 ordinary shares at $1.25 per share, aiming to raise approximately $8.0 million to fund clinical trials for its lead candidate, intranasal foralumab [1][3]. Group 1: Offering Details - The offering is conducted without an underwriter or placement agent and is targeted at senior management and existing shareholders [1]. - Participants in the offering will receive warrants to purchase additional shares at $1.50, potentially raising an additional $9.6 million [1]. - The offering is expected to close on January 16, 2026, pending customary closing conditions [1]. Group 2: Management Participation - CEO Ivor Elrifi purchased 2,400,000 ordinary shares, increasing his total holdings to 2,757,848 shares [2]. - Executive Chairman Gabriele Cerrone acquired 1,600,000 shares through Panetta Partners Ltd, raising his total holdings to 44,974,830 shares [2]. Group 3: Use of Proceeds - Proceeds from the offering will be utilized to complete Phase 2 clinical trials for non-active secondary progressive multiple sclerosis (na-SPMS) and multiple system atrophy (MSA), with top-line data expected from both trials [3]. Group 4: Product Information - Foralumab is a fully human anti-CD3 monoclonal antibody that stimulates T regulatory cells when administered intranasally [7]. - The drug is currently being tested in a Phase 2a trial for na-SPMS, with positive outcomes reported in an open-label program involving 14 patients [7]. - Foralumab represents a novel approach to treating neuroinflammatory and neurodegenerative diseases [8]. Group 5: Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies [8]. - The company aims to improve efficacy, safety, and tolerability of treatments compared to traditional intravenous delivery methods [8].

Core Viewpoint - Tiziana Life Sciences is set to present its lead candidate, intranasal foralumab, at the 9th Annual Neuroscience Innovation Forum, highlighting its potential in treating neurodegenerative conditions [1][3][4]. Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies, particularly intranasal administration [7]. - The company’s lead candidate, intranasal foralumab, is the only fully human anti-CD3 monoclonal antibody currently in clinical development, showing a favorable safety profile and clinical response in patients [6][7]. Product Details - Foralumab is designed to modulate the immune system and reduce microglial activation in neurodegenerative conditions, specifically targeting non-active secondary progressive multiple sclerosis (na-SPMS) [3][5]. - In an open-label intermediate sized Expanded Access Program, 14 patients with na-SPMS have been dosed, with all showing either improvement or stability of disease within 6 months [5]. Event Participation - CEO Ivor Elrifi will deliver a corporate presentation at the Neuroscience Innovation Forum, which is a key industry event featuring discussions on advancements in therapeutics and neurotechnology [1][3][4]. - Members of Tiziana's senior management team will also be available for one-on-one meetings with investors and stakeholders during the forum [2].

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company operates with a team of experienced and qualified news journalists across key finance and investing hubs including London, New York, Toronto, Vancouver, Sydney, and Perth [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The content delivered by the team includes insights across various sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Utilization - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company employs automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans to maintain best practices in content production and search engine optimization [5]

Core Viewpoint - Tiziana Life Sciences has submitted its seventh annual Development Safety Update Report (DSUR) to the FDA, reporting no drug-related serious adverse events for its lead candidate, intranasal foralumab, after 37.4 patient-years of cumulative exposure, emphasizing its safety profile in treating neuroinflammatory diseases [1][2][3]. Group 1: Safety and Efficacy of Foralumab - The DSUR indicates that there have been no serious adverse events attributed to intranasal foralumab, reinforcing its safety in clinical trials [2][3]. - The cumulative exposure of 37.4 patient-years demonstrates significant clinical experience with intranasal foralumab in central nervous system (CNS) indications [3][4]. - Adverse events reported were consistent with previous studies, and no new risks were identified that would require protocol modifications [3][4]. Group 2: Comparison with Other Treatments - The safety profile of intranasal foralumab aligns with prior studies of intravenous foralumab, which had been associated with infusion-related reactions, unlike the nasal delivery method that showed improved tolerability [4][10]. - The recent FDA denial of Sanofi's tolebrutinib for non-active secondary progressive multiple sclerosis (naSPMS) due to toxicity highlights the need for safer therapies in the neuroinflammatory disorder space [2][8]. Group 3: Clinical Development and Future Trials - Tiziana is conducting a Phase 2 trial of foralumab in naSPMS, with results expected in 2026 [2][5]. - Currently, 14 patients with naSPMS have been treated in an Expanded Access Program, showing either improvement or stability of disease within six months [5][9]. - Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development, representing a novel approach to treating neuroinflammatory and neurodegenerative diseases [6][10].

Core Insights - Tiziana Life Sciences has initiated its first patient dosing in an early Alzheimer's disease Phase 2 trial, marking a significant milestone for the company [1][4] - The FDA has approved the inclusion of both drug-naive patients and those previously treated with anti-amyloid therapies in the trial [1][7] Company Developments - The lead candidate, foralumab, is a fully human monoclonal antibody targeting CD3, aimed at reducing neuroinflammation associated with various neurodegenerative diseases [2][5] - Tiziana currently has three Phase 2 trials in progress for secondary progressive multiple sclerosis (SPMS), multiple system atrophy (MSA), and Alzheimer's, with a fourth trial for ALS expected to start in January [2][6] - Topline data readouts for all ongoing trials are anticipated in 2026, although the ALS study may extend into early 2027 depending on enrollment [2][10] Trial Details - The Phase 2 trial for Alzheimer's aims to assess the effects of foralumab both as a standalone treatment and in conjunction with existing anti-amyloid therapies [6][7] - The company believes that patients on anti-amyloid therapies still experience significant neuroinflammation, which they hope to address with foralumab [8] - The SPMS trial is particularly noteworthy as there are currently no approved therapies for this condition, and the company has received fast track designation from the FDA for this indication [9][10]