Core Viewpoint - Tiziana Life Sciences has commenced dosing in a Phase 2 clinical trial for intranasal foralumab, targeting non-active Secondary Progressive Multiple Sclerosis (na-SPMS) at Weill Cornell Medicine, expanding its research efforts in this area [1][2][3]. 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, demonstrating a favorable safety profile and clinical response in prior studies [7][6]. Clinical Trial Details - The Phase 2 trial aims to evaluate the safety and efficacy of intranasal foralumab in treating multiple sclerosis, a chronic autoimmune disease affecting the central nervous system [2]. - The trial includes multiple prestigious sites, with Weill Cornell Medicine being the latest addition, enhancing the collaborative effort in MS research [1][2][3]. - Following the blinded phase, all participants will have the opportunity to receive intranasal foralumab during a six-month open-label extension phase to assess long-term safety and sustained benefits [3]. Product Information - Foralumab is designed to engage regulatory T cells through a non-systemic approach, promoting immune tolerance while minimizing systemic immune suppression [4]. - Initial results from an open-label Expanded Access Program indicated that 10 patients with na-SPMS experienced either improvement or stability of disease within six months [5]. Industry Context - The development of intranasal foralumab represents a novel approach in the treatment of neuroinflammatory and neurodegenerative diseases, positioning Tiziana Life Sciences at the forefront of innovative therapies in this field [6].

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]

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive's content includes insights across various sectors such as biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

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 ...

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 has a team of experienced and qualified news journalists who produce independent content [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 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 Adoption - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans [5]

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]

Financial Performance - For the year ended December 31, 2024, total operating expenses were $15,794,000, a decrease of 12.1% from $17,984,000 in 2023[39] - Research and development expenses for 2024 were $5,229,000, down from $8,113,000 in 2023, reflecting a reduction of 35.5%[39] - The net loss attributable to ordinary shareholders for 2024 was $11,863,000, compared to $17,691,000 in 2023, indicating a 32.9% improvement[39] - Cash and cash equivalents as of December 31, 2024, were $3,724,000, a significant decrease from $18,122,000 in 2023[40] - Total assets decreased to $11,284,000 in 2024 from $12,184,000 in 2023, representing a decline of 7.4%[40] - Total shareholders' equity as of December 31, 2024, was $3,936,000, down from $5,534,000 in 2023, a decrease of 29%[40] - The basic and diluted net loss per ordinary share for 2024 was $0.11, an improvement from $0.15 in 2023[39] - The company incurred net losses of $12.0 million, $17.8 million, and $15.4 million for the years ended December 31, 2024, 2023, and 2022, respectively, with an accumulated loss of $146 million as of December 31, 2024[61] - The company anticipates continued significant expenses and increasing operating losses for the foreseeable future, impacting shareholders' equity and net assets[61] Product Development and Clinical Trials - The company is focused on the development of Foralumab, an anti-IL6R monoclonal antibody, with ongoing clinical trials[32] - Future revenue estimates and financing needs are uncertain and depend on the successful completion of clinical trials and regulatory approvals[32] - The company faces significant risks related to the development of its product candidates, including potential delays in clinical trials and regulatory approvals[44] - The company is developing Foralumab for various conditions, including secondary progressive multiple sclerosis and Type 1 Diabetes, with ongoing clinical trials planned[63] - The company has completed cGMP manufacturing of anti-IL6R mAb drug substance for treating interstitial lung disease associated with systemic sclerosis, with an IND submitted for a Phase 1 clinical trial[63] - The company faces challenges in patient enrollment for clinical trials, which could delay or prevent the progression of product candidates[50] - The company has not yet demonstrated the ability to successfully complete Phase 3 trials or obtain regulatory approvals for its product candidates[70] Regulatory and Compliance Risks - Regulatory authorities may impose additional testing requirements or withdraw approvals, which could adversely affect the company's business and prospects[62] - The company relies on additional financing to achieve business objectives, with potential dilution for current shareholders if capital is raised through equity issuance[66] - The company has incurred significant cash consumption since inception and expects expenses to increase with ongoing R&D and potential commercialization efforts[65] - The company’s reliance on third-party manufacturers for commercial supply subjects it to regulatory oversight, and any failure to comply with cGMP requirements could delay product approvals[80] - The company may face significant fluctuations in financial condition and operating results due to various uncontrollable factors[71] - The company relies on third-party CROs for preclinical studies and clinical trials, which may lead to delays and increased costs if they do not meet contractual obligations[72] - The company currently has no marketing and sales force, which poses a risk to the successful commercialization of its product candidates if effective distribution capabilities are not established[85] Market and Competitive Landscape - The company faces significant competition from larger pharmaceutical and biotechnology firms, which may have greater resources for R&D, clinical trials, and marketing[92] - The market opportunities for the company's product candidates may be smaller than anticipated due to potentially incorrect estimates of disease prevalence and patient accessibility[94] - The company anticipates that new developments in pharmaceutical technologies by competitors may render its product candidates obsolete or noncompetitive[91] - Market acceptance will depend on the effectiveness and safety of product candidates as demonstrated in clinical trials, as well as their perceived advantages over alternative treatments[96] - The company expects that coverage and adequate reimbursement by government and private payors will be essential for most patients to afford treatments[99] Intellectual Property and Patent Risks - The company relies heavily on licenses from third parties for essential patent rights and proprietary technology, which may not provide exclusive rights[108] - The patent prosecution process is expensive and complex, and the company may not be able to maintain or enforce all necessary patent applications[112] - The company faces risks related to the uncertainty of patent rights, which may not adequately protect its technology or provide a competitive advantage[116] - The company faces potential challenges to its patent rights from competitors, which could lead to patents being narrowed or invalidated[120] - The validity of licensed patents may be contested in courts, impacting the company's ability to commercialize its technology[121] - The company may struggle to maintain patent protection if compliance with procedural requirements is not met, risking loss of rights[135] - The ability to protect intellectual property rights globally is limited, with some jurisdictions offering less protection than the U.S.[138] - The company may face significant costs and challenges in enforcing patent rights in foreign jurisdictions[141] - Trade secrets are difficult to protect, and unauthorized disclosures could lead to loss of competitive advantages[142] - The biotechnology and pharmaceutical industries are characterized by extensive and complex litigation regarding patents and intellectual property rights, which could adversely affect the company's ability to commercialize its product candidates[146] Healthcare Regulations and Compliance - The company is subject to various federal and state healthcare fraud and abuse laws, which could result in penalties or suspension from healthcare programs if violated[203] - The company faces significant costs to ensure compliance with healthcare laws and regulations, with potential criminal and civil sanctions for non-compliance[206] - Compliance with environmental, health, and safety laws may result in substantial costs, fines, or penalties, potentially impacting the company's financial condition and operations[208] - The company does not maintain insurance for toxic tort claims related to the storage or disposal of hazardous materials, which could expose it to significant liabilities[209] - Future environmental, health, and safety regulations are expected to become more stringent, potentially impairing research, development, and production efforts[211] Strategic Growth and Resource Management - The company's long-term growth strategy relies on successfully identifying and developing new product candidates, which requires substantial resources and may not yield commercially viable products[212] - Limited resources may lead the company to delay or forego opportunities with potentially greater commercial potential, impacting overall growth[213] - The accuracy and reliability of scientific data are critical for the company's R&D efforts, and any irregularities could adversely affect business prospects and financial condition[214] - The company’s success is dependent on retaining key employees and attracting qualified personnel, with potential loss of key staff posing risks to achieving research and development objectives[216]