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 ...

BOSTON, Nov. 13, 2025 (GLOBE NEWSWIRE) -- 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 that its senior leadership team will present at the prestigious Jefferies London Healthcare Conference. Chief Executive Officer Ivor Elrifi and Chief Operating Officer/Chief Financial Officer Keeren Sha ...

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.

Core Insights - Tonix Pharmaceuticals is advancing its immunomodulatory candidate TNX-1500, targeting CD40-ligand (CD40L) to prevent organ transplant rejection and treat autoimmune diseases, as highlighted in a recent presentation by CEO Dr. Seth Lederman at the Japan Society for Transplantation Congress [1][2]. Company Overview - Tonix Pharmaceuticals is a fully integrated biotechnology company with marketed products and a pipeline of development candidates, including TNX-1500, which is designed to inhibit CD40L [4][5]. - The company has received FDA approval for Tonmya™, a non-opioid analgesic for fibromyalgia, marking the first new prescription medicine approval for this condition in over 15 years [5][6]. Product Development - TNX-1500 is an investigational humanized monoclonal antibody aimed at preventing allograft and xenograft rejection, as well as treating graft-versus-host disease (GvHD) and autoimmune diseases [4][6]. - The Phase 1 study of TNX-1500 showed favorable safety and biomarker data, supporting its continued development [2][4]. - The design of TNX-1500 aims to minimize thromboembolic risk while maintaining immunomodulatory activity, with plans for Phase 2 studies focusing on kidney transplant rejection and autoimmune indications [2][4]. Scientific Recognition - The presentation at the congress coincided with the awarding of the 2025 Nobel Prize in Physiology or Medicine to researchers who discovered T-regulatory cells, which are significant in immune response and organ transplant success [2][3]. Collaborative Efforts - The presentation included insights from academic collaborators, emphasizing the importance of CD154/CD40 blockade in transplantation, showcasing Tonix's engagement with the scientific community [3].

Core Insights - Tiziana Life Sciences has been invited to the J.P. Morgan Asset Management Life Science Innovation Forum 2025, highlighting its position in the biotechnology sector [1][2][3] Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using transformational drug delivery technologies [5] - The company's lead candidate, intranasal foralumab, is the only fully human anti-CD3 monoclonal antibody currently in clinical development [4][5] Product Development - Foralumab has shown promise in stimulating T regulatory cells when administered intranasally, with positive outcomes observed in patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) [3][4] - In an open-label intermediate sized Expanded Access Program, all 14 patients treated exhibited either improvement or stability of disease within 6 months [3] - Foralumab is also undergoing a Phase 2a randomized, double-blind, placebo-controlled trial for na-SPMS [3] Industry Context - The Life Science Innovation Forum aims to accelerate the transition of life science research into market-ready solutions and strengthen the biotechnology value chain [2] - The event is aligned with Saudi Arabia's National Biotechnology Strategy, promoting a thriving ecosystem for life sciences [2]

Tivic Health Systems Conference Summary Company Overview - **Company**: Tivic Health Systems (NasdaqCM:TIVC) - **Focus**: Development of non-invasive medical devices targeting neural pathways and a strong late-stage pipeline in biopharmaceuticals, particularly in immunomodulation and cancer therapeutics [1][2] Key Points Transformation and Pipeline Development - Tivic Health has undergone a significant transformation by acquiring newly licensed assets, leading to a robust late-stage portfolio in biopharmaceuticals [2] - The company maintains a clean capital structure with no debt and anticipates significant value inflection points in the near future [2] Biopharmaceutical Focus - The company is focusing on immunomodulation, utilizing the immune system to combat diseases and improve health outcomes [3] - A biologic licensing agreement was established, including a phase three recombinant protein funded by BARDA for radiation countermeasures, with potential applications in cancer [3][4] Entolimod and Market Opportunities - **Entolimod**: A TLR5 agonist with dual capabilities to treat acute radiation syndrome and cancer-related conditions, showing a 300% increase in survival rates with a single dose [9][23] - The market for GCSF drugs, which Entolimod aims to compete against, is valued at approximately $7.2 billion in 2023, with a broader neutropenia market of around $20 billion [9][31] - Entolimod is positioned as a military countermeasure for nuclear disasters, with a potential market opportunity of $5.2 billion for stockpiling [9][10] Clinical and Regulatory Progress - The company has made significant strides in customer engagement and manufacturing agreements, moving towards a Biologics License Application (BLA) filing [5][10] - The FDA has granted fast track and orphan drug designations for Entolimod, facilitating expedited regulatory processes [11] Future Directions and Strategic Focus - The company plans to focus on Entolimod over the next 6 to 18 months while also exploring other high-potential areas, including cancer therapeutics and vagus nerve stimulation technologies [17][35] - By 2026, Tivic Health aims to have GMP materials ready, FDA meetings completed, and customer interest solidified [34] Additional Insights - The company operates with a capital-light model and has a strong team with extensive experience in drug launches and biopharmaceutical development [16][25] - There is potential for partnerships with larger organizations to scale production and market reach effectively [29] - The vagus nerve technology remains a promising area for future development, with established research backing its efficacy [13][12] Conclusion Tivic Health Systems is positioned for growth with its innovative biopharmaceutical pipeline, particularly through Entolimod, which addresses significant market needs in radiation countermeasures and cancer therapeutics. The company's strategic focus on regulatory pathways and partnerships will be crucial for its success in the coming years.

Core Viewpoint - Tiziana Life Sciences is advancing its second asset, TZLS-501, a fully human anti-IL-6 receptor monoclonal antibody, amidst increased industry activity in the IL-6 pathway, highlighted by Novartis' acquisition of Tourmaline Bio for approximately $1.4 billion [1][3]. Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing breakthrough therapies using innovative drug delivery technologies, particularly intranasal administration [9][10]. Product Development - TZLS-501 targets both membrane-bound and soluble forms of IL-6R, potentially offering therapeutic advantages in managing diseases characterized by excessive IL-6 signaling, such as rheumatoid arthritis, acute respiratory distress syndrome, and various cancers [2][4]. - The company plans to pursue non-dilutive funding strategies for the development of TZLS-501 while continuing to advance its lead program, intranasal foralumab [1][3]. Market Context - The recent acquisition by Novartis underscores the growing importance of IL-6 therapeutics, positioning Tiziana to capitalize on this trend with the development of TZLS-501 [3][5]. - The dual mechanism of action of TZLS-501, which inhibits IL-6R signaling and reduces circulating IL-6 cytokines, is seen as a significant advancement in treating acute and chronic inflammatory conditions [2][6]. Clinical Programs - Foralumab, Tiziana's lead candidate, is currently being studied in clinical trials for its efficacy in treating non-active secondary progressive multiple sclerosis, with positive outcomes reported in initial patient dosing [7][8].

Core Viewpoint - Tiziana Life Sciences is presenting a scientific poster on its Phase 2a clinical trial of intranasal foralumab for treating non-active secondary progressive multiple sclerosis at the ECTRIMS Congress, highlighting its innovative approach in immunomodulation therapies [1][2][4]. Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing breakthrough therapies using novel drug delivery technologies, particularly intranasal delivery for immunotherapy [6][8]. - 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 preliminary studies [5][8]. Clinical Trial Details - The poster presentation titled "Study Design of a Phase 2a Double-Blind Placebo-Controlled Trial of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis" outlines the trial's design and objectives [2][7]. - The Phase 2a trial aims to evaluate the efficacy and safety of nasal foralumab in patients with non-active secondary progressive multiple sclerosis, a group with limited treatment options [4][5]. Event Information - The ECTRIMS Congress, where the poster will be presented, is the largest annual international conference dedicated to multiple sclerosis research, taking place from September 24-26, 2025, in Barcelona, Spain [1][4][7].

Core Viewpoint - Tiziana Life Sciences has received a research grant from the U.S. Department of Defense to study intranasal anti-CD3 therapy for traumatic spinal cord injury, expanding its therapeutic potential into significant neurological conditions [1][2][3]. Group 1: Research and Development - The DoD grant will fund a three-year study focusing on the acute phase of spinal cord injury, targeting patients who arrive at the hospital immediately after injury [2]. - A complementary two-year Stepping Strong Breakthrough Award will investigate the chronic phase of spinal cord injury, concentrating on patients with ongoing neurological deficits [2]. - Tiziana's lead candidate, intranasal foralumab, is a fully human anti-CD3 monoclonal antibody that has shown promise in stimulating T regulatory cells and improving disease stability in patients with non-active secondary progressive multiple sclerosis [6][7]. Group 2: Market Opportunity - Traumatic spinal cord injury affects nearly 300,000 Americans with permanent disabilities and sees over 17,000 new injuries each year, representing a significant unmet medical need [3]. - Current treatments are primarily supportive, with no approved therapies that enhance neurological recovery or prevent chronic complications from spinal cord inflammation, indicating a substantial commercial opportunity for Tiziana [3]. Group 3: Mechanism and Benefits - Intranasal anti-CD3 therapy aims to rebalance the immune system, reduce inflammation in the injured spinal cord, and support functional recovery, potentially benefiting other acute central nervous system injuries [4][5]. - Preclinical results have indicated that this non-invasive therapy could improve motor outcomes, enhancing independence and quality of life for patients [4].

Core Insights - Tiziana Life Sciences has initiated a Phase 2a clinical trial for intranasal foralumab in patients with Multiple System Atrophy (MSA), marking a significant step in developing therapies for this rare neurodegenerative disorder [1][3]. Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies, particularly through nasal administration [9]. - 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 [9][7]. Clinical Trial Details - The Phase 2a trial will evaluate the efficacy of foralumab in reducing neuroinflammation and aims to determine its potential to slow disease progression and improve quality of life for MSA patients [3][4]. - The trial involves a six-month open-label study with participants receiving treatment over eight dosing cycles [3]. Disease Context - Multiple System Atrophy is a rare and rapidly progressive neurodegenerative disorder affecting an estimated 15,000–50,000 individuals in the U.S., with no FDA-approved treatments available to alter its course [2][5]. - The disease leads to severe movement, balance, and autonomic function issues, with most patients surviving only 6–9 years post-diagnosis [5]. Mechanism of Action - Foralumab works by stimulating T regulatory cells through a novel, non-systemic delivery approach, targeting the immune processes that may drive neurodegeneration [4][6]. - Early studies have indicated potential benefits of foralumab in stabilizing or improving function in other neuroinflammatory conditions, such as multiple sclerosis [4][6].