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]

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About this content About Ian Lyall Ian Lyall, a seasoned journalist and editor, brings over three decades of experience to his role as Managing Editor at Proactive. Overseeing Proactive's editorial and broadcast operations across six offices on three continents, Ian is responsible for quality control, editorial policy, and content production. He directs the creation of 50,000 pieces of real-time news, feature articles, and filmed interviews annually. Prior to Proactive, Ian helped lead the business output a ...

Exhibit 99.1 NEW YORK, May 6, 2025 – Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) ("Tiziana" or the "Company"), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti- CD3 monoclonal antibody, today announced promising results from an open-label clinical study evaluating nasal foralumab, the world's only fully human anti-CD3 monoclonal antibody administered intranasally, for the treatment of non-active secondary ...

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]

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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]

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 focuses on sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Group 2 - Proactive adopts technology enthusiastically, utilizing decades of expertise and experience among its content creators [4] - The company employs automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

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].