Core Viewpoint - Tiziana Life Sciences is advancing its lead candidate, intranasal foralumab, a fully human anti-CD3 monoclonal antibody, which has shown promising results in treating neuroinflammatory and neurodegenerative diseases, particularly in patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) [1][2][3]. Group 1: Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using transformational drug delivery technologies [4]. - 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 previous studies [4]. - Tiziana's intranasal approach aims to improve efficacy, safety, and tolerability compared to traditional intravenous delivery methods [4]. Group 2: Product Development - Foralumab has been administered to 14 patients with na-SPMS in an open-label Expanded Access Program, with all patients showing either improvement or stability of disease within six months [2]. - The drug is also undergoing a Phase 2a randomized, double-blind, placebo-controlled trial to further assess its efficacy in patients with non-active secondary progressive multiple sclerosis [2][3]. - The immunomodulation potential of intranasal foralumab represents a novel treatment avenue for neuroinflammatory and neurodegenerative diseases [3]. Group 3: Executive Actions - Mr. Gabriele Cerrone, the Executive Chairman and Founder of Tiziana, has purchased 97,687 common shares, increasing his total holdings to 43,374,830 shares, which constitutes 36.08% of the company's issued share capital [1].

Core Viewpoint - Tiziana Life Sciences is celebrating a significant milestone by ringing the Nasdaq Closing Bell, highlighting its advancements in immunomodulation therapies, particularly its lead candidate, intranasal foralumab, which targets neurodegenerative and inflammatory diseases [1][2][3]. Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using transformational drug delivery technologies, specifically intranasal delivery methods [6]. - 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 [5][6]. Product Development - Intranasal foralumab aims to improve efficacy, safety, and tolerability compared to traditional intravenous methods, targeting diseases such as multiple sclerosis, Alzheimer's disease, and ALS [2][6]. - The company has recently achieved significant milestones, including the dosing of the first patient in its Phase 2 Alzheimer's trial and expansions in other key studies [3][4]. Clinical Trials - Foralumab has been administered to 14 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) in an open-label program, with all patients showing either improvement or stability of disease within six months [4]. - The drug is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled trial for non-active secondary progressive multiple sclerosis [4].

Core Viewpoint - Tiziana Life Sciences has initiated a Phase 2 clinical trial for intranasal foralumab, targeting early Alzheimer's disease, marking a significant step in exploring immunomodulatory therapies for neuroinflammation [1][3][7]. Group 1: Clinical Trial Details - The Phase 2 trial is randomized and placebo-controlled, assessing the safety, tolerability, and potential efficacy of intranasal foralumab as both a monotherapy and in combination with FDA-approved anti-amyloid therapies, lecanemab or donanemab [4]. - Primary endpoints of the trial include neuroinflammation measured by TSPO-PET imaging, cognitive function, and changes in amyloid and tau biomarkers, with interim data expected in 2026 [4]. Group 2: Scientific Rationale - TSPO-PET imaging data indicates persistent microglial activation in Alzheimer's patients, even after treatment with anti-amyloid therapies, highlighting the need for therapies that address residual neuroinflammation [2]. - Intranasal foralumab is designed to modulate immune responses and reduce activated microglia, potentially slowing disease progression in early Alzheimer's disease [2][3]. Group 3: Company Insights - Gabriele Cerrone, Chairman & Founder, emphasized the importance of this trial in exploring a novel approach to Alzheimer's treatment, building on previous data showing foralumab's ability to reduce microglial activation in multiple sclerosis patients [3]. - Ivor Elrifi, CEO, expressed enthusiasm for the rapid progress from enrollment to first patient dosing, reflecting the urgent need for new treatment strategies beyond amyloid clearance [3]. Group 4: About Foralumab - Foralumab is a fully human anti-CD3 monoclonal antibody that stimulates T regulatory cells when administered intranasally, with previous studies showing positive outcomes in patients with non-active secondary progressive multiple sclerosis [5][6]. - It is the only fully human anti-CD3 monoclonal antibody currently in clinical development, representing a novel treatment avenue for neuroinflammatory and neurodegenerative diseases [6]. Group 5: Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies, aiming to improve efficacy, safety, and tolerability compared to traditional intravenous delivery methods [6][8].

Core Viewpoint - Tiziana Life Sciences has announced the withdrawal of its proposed public offering of common shares due to unfavorable market conditions [1]. Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative immunomodulation therapies, particularly through its lead candidate, intranasal foralumab, which is a fully human anti-CD3 monoclonal antibody [3]. - The company aims to improve the efficacy, safety, and tolerability of immunotherapy by utilizing alternative drug delivery methods, specifically through nasal administration [3]. - Tiziana's technology for alternative routes of immunotherapy has been patented, with several applications pending, indicating potential for broad pipeline applications [3]. Product Information - Foralumab is the only fully human anti-CD3 monoclonal antibody currently in clinical development, showing promise in stimulating T regulatory cells when administered intranasally [5][6]. - In an open-label intermediate-sized Expanded Access Program, 14 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been treated, with all patients showing either improvement or stability of disease within six months [5]. - Foralumab is also undergoing a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial for patients with non-active secondary progressive multiple sclerosis [5].

Core Viewpoint - Tiziana Life Sciences has initiated enrollment for a Phase 2 clinical trial of intranasal foralumab, targeting early Alzheimer's disease, with the first patient expected to be dosed next week [1][10]. Group 1: Clinical Trial Details - The Phase 2 trial will assess intranasal foralumab as both a monotherapy and in combination with FDA-approved anti-amyloid therapies, lecanemab or donanemab, in early Alzheimer's patients [2][9]. - Baseline assessments including cognitive testing and TSPO-PET imaging have been completed for initial participants [2][11]. - Key endpoints of the trial will include measures of neuroinflammation, cognitive function, and changes in biomarkers related to amyloid and tau pathology [11]. Group 2: Scientific Insights - New TSPO-PET imaging evidence shows persistent microglial activation in an Alzheimer's patient treated with lecanemab, indicating ongoing neuroinflammation despite amyloid plaque reduction [3][4]. - Dr. Howard Weiner emphasized that clearing amyloid does not eliminate the brain's inflammatory response, suggesting that intranasal foralumab may effectively address this residual neuroinflammation [6][10]. Group 3: Mechanism of Action - Intranasal foralumab is designed to induce regulatory T cells to migrate to the brain, potentially calming activated microglia and reducing neuroinflammation [6][10]. - The therapy aims to provide an additive or synergistic benefit when used alongside anti-amyloid treatments by targeting both amyloid pathology and persistent microglial inflammation [9][10]. Group 4: Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies, with intranasal foralumab being the only fully human anti-CD3 monoclonal antibody in clinical development [13]. - The company aims to improve efficacy, safety, and tolerability of treatments compared to traditional intravenous delivery methods [13].

Financial Data and Key Metrics Changes - The company is focused on the upcoming data readout for setrusumab, which is expected by the end of the year or early January, marking a significant near-term value driver [2][34] - The company has achieved a 67% reduction in fracture rates from baseline in the Orbit trial, indicating strong efficacy of setrusumab [8][15] Business Line Data and Key Metrics Changes - The company is advancing its gene therapy programs, particularly for Sanfilippo and GSDIa, with both expected to file for approval within the PRV window by the end of September [38][91] - The company is also conducting a seamless phase I/II/III study for Wilson disease, aiming to demonstrate the efficacy of its gene therapy in reducing the need for chelators [52][54] Market Data and Key Metrics Changes - The potential market for Osteogenesis Imperfecta (OI) is estimated at 60,000 patients in the covered geographies, presenting a unique opportunity for the company [3][4] - For Sanfilippo, the patient population is estimated between 3,000 and 5,000, while GSDIa has around 6,000 patients, indicating significant market potential for these gene therapies [42] Company Strategy and Development Direction - The company aims to leverage lessons learned from the successful launch of Crysvita to enhance the launch of setrusumab for OI [4] - The strategy includes not compromising data quality to meet regulatory deadlines, emphasizing the importance of robust data packages for successful product launches [30][92] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming data readouts and the potential for successful regulatory filings, highlighting the importance of these products to the company's future [34][92] - The company is actively exploring the use of AI to streamline data analysis and document preparation, aiming to enhance efficiency in the approval process [32] Other Important Information - The company has successfully monetized a deal with OMERS for Crysvita, which is expected to provide financial flexibility as it approaches profitability [91] - The company is committed to ensuring that all patient populations affected by Angelman syndrome can benefit from its therapies, aiming for a full label upon approval [87] Q&A Session Summary Question: What is the timeline for the data readouts for setrusumab? - The company has defined the end of the year as December or January for the data readouts, indicating a near-term timeline [34] Question: How does the company view the efficacy of bisphosphonates compared to setrusumab? - Management estimates the treatment effect of bisphosphonates to be around 20%, while setrusumab has shown a 67% reduction in fracture rates, indicating a significant improvement [15][16] Question: What is the company's approach to regulatory filings for Sanfilippo and GSDIa? - The company plans to refile for Sanfilippo early next year and is on track to complete the rolling BLA for GSDIa this month, both aiming for PDUFA dates within the PRV window [38][91] Question: How does the company plan to address the potential for opportunistic infections with immunomodulation therapies? - Management indicated that while there are concerns with immunosuppressants like sirolimus, the focus is on optimizing efficacy and safety through careful study design [67]

Core Viewpoint - Tiziana Life Sciences plans to spin out its fully human anti-IL-6 receptor monoclonal antibody, TZLS-501, into a separate publicly traded company to enhance strategic focus and drive shareholder value [1][2][3]. Group 1: Company Strategy - The decision to advance TZLS-501 is influenced by increased industry interest in the IL-6 pathway, highlighted by Novartis' $1.4 billion acquisition of Tourmaline Bio for its IL-6 inhibitor [2][3]. - The spin-out aims to create a standalone entity focused on the IL-6 market, with the record date for the transaction to be announced soon [2][3]. - TZLS-501 will remain an asset of Tiziana until shareholders approve the spin-out proposals [2]. Group 2: Product Overview - TZLS-501 is a dual-action IL-6R monoclonal antibody that targets both membrane-bound and soluble forms of IL-6R, potentially serving as a monotherapy or in combination with other treatments [2][4]. - The mechanism of TZLS-501 involves blocking IL-6R signaling and reducing circulating IL-6 levels, addressing systemic inflammation and related diseases [4]. Group 3: Other Developments - Tiziana's lead candidate, intranasal foralumab, is currently in clinical trials and has shown positive results in patients with Non-Active Secondary Progressive Multiple Sclerosis [5][6]. - Foralumab represents a novel approach to immunomodulation, being the only fully human anti-CD3 monoclonal antibody in clinical development [6].

BOSTON, Nov. 25, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies, today announced that its Phase 2 clinical trial evaluating intranasal foralumab in patients with amyotrophic lateral sclerosis (ALS) has been accepted for inclusion in the ALS MyMatch Program at the Sean M. Healey & AMG Center for ALS at Mass General Brigham. The study, supported by a grant from the ALS Association, wil ...

Core Viewpoint - Tiziana Life Sciences is participating in the Jefferies London Healthcare Conference to present its innovative pipeline and recent clinical milestones, particularly focusing on its lead candidate, intranasal foralumab, which targets neurodegenerative diseases [1][2][3]. Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies, specifically intranasal foralumab, a fully human anti-CD3 monoclonal antibody [6]. Product Details - Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development, administered intranasally for conditions such as non-active secondary progressive multiple sclerosis (SPMS), Alzheimer's disease (AD), multiple system atrophy (MSA), and amyotrophic lateral sclerosis (ALS) [2][5]. - In an open-label intermediate sized Expanded Access Program, 14 patients with non-active SPMS have shown either improvement or stability of disease within 6 months [5]. Clinical Trials - Foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial for non-active SPMS [5]. Conference Participation - The Jefferies London Healthcare Conference will take place on November 19, 2025, where Tiziana's management will present and be available for one-on-one meetings [4].

Summary of SAB Biotherapeutics Conference Call Company Overview - **Company**: SAB Biotherapeutics (NasdaqCM:SABS) - **Focus**: Development of SAB-142, a drug for type 1 diabetes aimed at preserving beta cells using a trans-chromosomic bovine platform that produces human IgG [4][5] Core Points and Arguments - **Drug Development**: SAB-142 is designed to replicate the efficacy of Thymoglobulin, a drug by Sanofi, which has shown effectiveness in preserving beta cells but has a poor safety profile due to its rabbit origin [4][5] - **Clinical Trials**: SAB-142 is entering a pivotal phase 2b trial called the Safeguard trial, targeting newly diagnosed type 1 diabetes patients [5][46] - **Market Position**: SAB Biotherapeutics aims to compete with Sanofi's TZIELD, which is approved for stage 2 type 1 diabetes, while SAB-142 targets stage 3, the more prevalent form of the disease [6][9] - **Efficacy Expectations**: The company expects SAB-142 to demonstrate similar efficacy to Thymoglobulin, with a target of 40% preservation of C-peptide compared to placebo at one year [43][44] - **Safety Profile**: Phase 1 results indicate that SAB-142 does not cause serum sickness or immunogenic responses, allowing for redosing [5][10][12] Important Data and Metrics - **C-Peptide Preservation**: The primary endpoint of the Safeguard trial is the preservation of C-peptide, a marker for beta cell function, with a goal of 40% preservation compared to placebo [43][44] - **Trial Timeline**: The trial is currently underway, with data expected in the second half of 2027 [46] - **Financial Position**: As of August 31, the company has $164 million in cash, sufficient to fund the phase 2b study and operations through 2028 [104][105] Competitive Landscape - **TZIELD Comparison**: TZIELD is priced at $200,000, which serves as a benchmark for SAB-142's pricing strategy [80][82] - **Other Treatments**: The company acknowledges competition from cell therapy programs and GLP-1 drugs but emphasizes that their focus on immunomodulation is crucial for preserving beta cells [113][115] Regulatory Path and Future Opportunities - **Regulatory Agreement**: The FDA has agreed that the Safeguard trial qualifies as a registrational study, which could expedite the approval process [48][53] - **Expansion Potential**: SAB-142 may have applications in other T-cell-mediated autoimmune diseases, indicating potential for a franchise-like product [87][89] - **Global Market**: The company is opening trial sites in the U.S., Europe, U.K., Australia, and New Zealand, indicating a broad market opportunity [95][97] Additional Insights - **Market Awareness**: The success of TZIELD has increased focus on the unmet medical needs in type 1 diabetes, benefiting SAB Biotherapeutics by raising awareness [116][119] - **Investor Interest**: There is significant interest from potential partners, including Sanofi, which could lead to strategic collaborations [102][100] This summary encapsulates the key points discussed during the conference call, highlighting the strategic direction, clinical development, and market positioning of SAB Biotherapeutics.