Core Insights - Tiziana Life Sciences is developing intranasal foralumab, a fully human anti-CD3 monoclonal antibody, aimed at treating neuroinflammatory and neurodegenerative diseases [1][3][4] - The company is conducting a Phase 2 trial for non-active Secondary Progressive Multiple Sclerosis (na-SPMS) and plans to initiate a Phase 2 trial for early Alzheimer's Disease [1][2] Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on innovative drug delivery technologies for immunotherapy [4] - 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 [4] Clinical Development - The Phase 2 trial for intranasal foralumab in na-SPMS began patient screening in November 2023, with positive outcomes reported in an open-label program involving 10 patients [2][3] - The drug is designed to stimulate T regulatory cells through intranasal administration, promoting immune tolerance while minimizing systemic immune suppression [1][2]

Core Insights - Tiziana Life Sciences has made advancements in treating moderate Alzheimer's disease with its intranasal foralumab, a fully human anti-CD3 monoclonal antibody, which targets brain inflammation [1][2][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 [6] - The company’s lead candidate, foralumab, is the only fully human anti-CD3 monoclonal antibody currently in clinical development, demonstrating a favorable safety profile and clinical response in previous studies [5][6] Clinical Developments - The first patient treated with intranasal foralumab, Joe Walsh, showed significant reduction in brain inflammation, indicating a promising step forward in Alzheimer's treatment [2][3] - Foralumab is also being studied in a Phase 2a trial for patients with non-active secondary progressive multiple sclerosis, with positive outcomes observed in an open-label program [4][5] Treatment Mechanism - Foralumab works by stimulating T regulatory cells through intranasal dosing, which helps mitigate inflammation in the brain, a critical factor in the progression of Alzheimer's disease [4][5]

Financial Data and Key Metrics Changes - Revenue for Q1 2025 totaled $70,000, a decline from $334,000 in Q1 2024, primarily due to an 81% decrease in unit sales linked to a 92% reduction in advertising spend [11][12] - Cost of sales decreased to $20,000 from $167,000 in the prior year, resulting in an increase in gross margins from 50% to 72% [12] - Operating expenses remained flat at $1,600,000 for Q1 2025 compared to the same period in 2024, with a net loss of $1,500,000 for both quarters [12][13] - Cash and cash equivalents were $669,000 as of March 31, 2025, down from $2,000,000 at the end of 2024 [13] Business Line Data and Key Metrics Changes - The company transitioned from a single product focus to a diversified immunotherapeutics company, emphasizing a clinical pipeline targeting immune system dysregulation [4][5] - Significant investment was made in securing biopharmaceutical assets and supporting clinical research in non-invasive vagus nerve stimulation [9] Market Data and Key Metrics Changes - The treatment market for neutropenia is expected to reach $20 billion by 2029, indicating a substantial growth opportunity for the company [36] Company Strategy and Development Direction - The company is focused on enhancing shareholder value by prioritizing assets with the greatest potential for substantial returns, including the licensing agreement for entelimod [9][10] - A strategic shift towards immunotherapeutics is underway, with plans to advance both late and early-stage treatments in the pipeline [42] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the high economic uncertainty and the impact of reduced advertising on revenue, but emphasized the importance of capital management for future returns [10] - The company views 2025 as a year of tremendous opportunity with several key milestones expected in the second half of the year [44] Other Important Information - The FDA granted Fast Track status and orphan drug status for entelimod, with potential for accelerated pathways and emergency use designations [37] - The company has secured an $8.4 million tranche funding agreement to support its transformation [8] Q&A Session Summary - No specific questions and answers were provided in the content, as the call was pre-recorded and questions were submitted in advance.

Core Insights - Tiziana Life Sciences announced a study demonstrating that intranasal foralumab significantly reduced microglial activation in a 78-year-old patient with moderate Alzheimer's disease, indicating a potential new treatment avenue for neurological disorders [1][2][7] Company Overview - Tiziana Life Sciences is a biotechnology company focused on developing immunomodulation therapies, with its lead candidate being intranasal foralumab, a fully human anti-CD3 monoclonal antibody [1][12] - The company aims to provide alternative routes of immunotherapy, which may enhance efficacy and safety compared to traditional intravenous delivery methods [12] Study Findings - The study published in the Journal of Clinical Nuclear Medicine utilized advanced PET imaging to assess microglial activation before and after treatment, revealing a notable reduction in neuroinflammation following intranasal foralumab administration [2][5] - This case marks the first use of 18F-PBR06-PET in a patient with moderate Alzheimer's disease and the first report of an Alzheimer's patient treated with nasal-foralumab [2][8] Future Directions - Tiziana Life Sciences plans to initiate a phase-2a study of nasal-foralumab in mild Alzheimer's disease, addressing the unmet need for disease-modifying therapies in this area [8][10] - The company has previously reported similar effects of nasal-foralumab in reducing microglial activation in patients with non-active secondary progressive multiple sclerosis [8][10]

Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. The non-active SPMS intranasal foralumab Phase 2 trial (NCT06292923) began screening patients in November of 2023. Immunomodulation by intranasal foralumab represents a novel avenue for treatment of neuroinflammatory and neurodegenerative human diseases. NEW YORK, May 12, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) ("Tiziana" or the "Company"), a biotechnology company developing bre ...

Core Insights - Tiziana Life Sciences announced significant results from a PET scan showing a marked reduction in microglia activation in a patient with moderate Alzheimer's disease after three months of treatment with intranasal foralumab, indicating potential efficacy in reducing neuroinflammation associated with the disease [1][5][7] Company Overview - Tiziana Life Sciences is a biotechnology company focused on developing innovative immunomodulation therapies, with its lead candidate being intranasal foralumab, a fully human anti-CD3 monoclonal antibody [1][9] - The company aims to address the urgent need for effective treatments for Alzheimer's disease, particularly in moderate stages, as current approved therapies are lacking [7][9] Treatment Mechanism - Intranasal foralumab works by inducing T regulatory cells (Tregs) that travel to the brain to reduce neuroinflammation, which has been confirmed in both animal models and patients with secondary progressive multiple sclerosis [6][9] - The treatment has shown a favorable safety profile and clinical response in ongoing studies, with all 10 patients in an open-label program experiencing either improvement or stability of their condition within six months [8][9] Research and Development - The findings were presented at the 2025 AD/PD Conference and highlight the need for further studies to explore the effects of foralumab in a broader patient population with moderate Alzheimer's disease [5][7] - Tiziana's innovative nasal delivery approach is expected to enhance the efficacy and safety of immunotherapy compared to traditional intravenous methods [9] Market Context - Alzheimer's disease currently affects over 50 million people worldwide, with projections indicating that this number could triple by 2050, underscoring the critical demand for new treatment options [7][9]

Core Insights - Tiziana Life Sciences announced significant results from a PET scan showing a marked reduction in microglia activation in a patient with moderate Alzheimer's disease after three months of treatment with intranasal foralumab, indicating potential efficacy in reducing neuroinflammation associated with the disease [1][5][7] Company Overview - Tiziana Life Sciences is a biotechnology company focused on developing innovative immunomodulation therapies, with intranasal foralumab as its lead candidate, which is a fully human anti-CD3 monoclonal antibody [1][10] - The company aims to provide alternative routes of immunotherapy, potentially improving efficacy and safety compared to traditional intravenous delivery methods [10] Treatment Efficacy - The PET scan results presented at the 2025 AD/PD Conference indicated a substantial decrease in TSPO signal, suggesting that foralumab may effectively reduce microglial activation, a critical factor in neuroinflammation related to Alzheimer's disease [5][7] - Foralumab has shown promise not only in Alzheimer's but also in other neurodegenerative diseases, including secondary progressive multiple sclerosis, where it has demonstrated stabilization or improvement of symptoms [6][8][10] Market Need - Alzheimer's disease currently affects over 50 million people worldwide, with projections indicating that this number could triple by 2050, highlighting the urgent need for effective treatments, particularly for moderate stages of the disease [7][10]

Core Insights - Tiziana Life Sciences announced promising results from an open-label clinical study of intranasal foralumab for treating non-active secondary progressive multiple sclerosis (na-SPMS), demonstrating safety, regulatory immune response induction, and clinical progression stabilization [1][3][6] Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies, particularly intranasal foralumab, the only fully human anti-CD3 monoclonal antibody in clinical development [10][9] Study Findings - The study showed that nasal foralumab was safe, reduced microglial activation, and stabilized clinical progression in patients with na-SPMS, addressing a significant unmet need in MS treatment [1][4][6] - All ten patients treated for a minimum of six months experienced stabilization of Expanded Disability Status Scale (EDSS) scores, with some showing improvement [7][6] - Significant reductions in microglial activation were observed at six months, with a p-value of less than 0.05 [6][7] Future Developments - Tiziana Life Sciences has initiated a randomized, double-blind, placebo-controlled Phase 2 clinical trial to further evaluate the efficacy and safety of nasal foralumab, with top-line data expected by the end of 2025 [5][8] - The company is also exploring the potential of nasal foralumab in treating other conditions such as Alzheimer's Disease and ALS [8]

Core Insights - Tiziana Life Sciences has commenced dosing at the fourth clinical site for its Phase 2 trial of intranasal foralumab in patients with non-active secondary progressive multiple sclerosis (na-SPMS) [1][2][3] - The trial is a blinded, placebo-controlled study expected to conclude by the end of 2025, followed by a six-month open-label extension phase for all participants [2][4] - Foralumab is the first fully human anti-CD3 monoclonal antibody administered intranasally, designed to promote immune tolerance while minimizing systemic immune suppression [3][5] Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies [5] - The company’s lead candidate, intranasal foralumab, has shown a favorable safety profile and clinical response in previous studies [5] - Tiziana's approach aims to improve efficacy, safety, and tolerability compared to traditional intravenous delivery methods [5] Clinical Development - The Phase 2 trial began screening patients in November 2023, with the addition of the University of Massachusetts as a clinical site [1][5] - Initial results from an open-label Expanded Access Program indicated that all 10 patients with na-SPMS experienced either improvement or stability of disease within six months [4] - The trial's design includes a focus on long-term safety and sustained benefits of foralumab in the na-SPMS patient population [2][4]

Core Viewpoint - Tiziana Life Sciences is advancing its Phase 2 trial of intranasal foralumab for treating non-active Secondary Progressive Multiple Sclerosis (na-SPMS), with dosing now initiated at Johns Hopkins University, marking a significant milestone in the company's clinical development efforts [1][3]. Group 1: Clinical Trial Details - The Phase 2 trial is randomized, double-blind, and placebo-controlled, focusing on the safety, tolerability, and efficacy of intranasal foralumab in na-SPMS patients, a form of multiple sclerosis characterized by progressive neurological decline without relapses [2][3]. - The trial includes multiple clinical sites, with Johns Hopkins University being the third site added, alongside Brigham and Women's Hospital and MS Center at Yale Medical Center [1][3]. - The blinded portion of the trial is expected to be completed by the end of 2025, followed by a six-month open-label extension period for all participants [3]. Group 2: Drug Candidate Information - Foralumab is a fully human anti-CD3 monoclonal antibody that stimulates T regulatory cells when administered intranasally, representing a novel approach to treating neuroinflammatory and neurodegenerative diseases [4][5]. - In an open-label intermediate-sized Expanded Access Program, 10 patients with na-SPMS have shown either improvement or stability of disease within six months [4]. - Foralumab is currently the only fully human anti-CD3 monoclonal antibody in clinical development, with its Phase 2 trial having begun patient screening in November 2023 [5]. Group 3: Company Commitment and Innovation - Tiziana Life Sciences emphasizes its commitment to innovation in treating neurodegenerative diseases, reinforced by the expansion of the trial to a major clinical site [4]. - The company believes that intranasal foralumab could represent a paradigm shift in addressing non-active Secondary Progressive MS, aiming to provide new hope for patients [4][6]. - Tiziana's innovative nasal drug delivery technology is expected to improve efficacy, safety, and tolerability compared to traditional intravenous delivery methods [6].