Tiziana Submits 37.4 Patient-Years Safety Report for Intranasal Foralumab
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 29 2025
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Should l Buy TLSA?
Source: Newsfilter
- Safety Milestone: Tiziana reports no serious adverse events after 37.4 patient-years of cumulative exposure to intranasal foralumab, demonstrating its favorable safety profile in treating neuroinflammatory diseases, which could provide a significant therapeutic option in the future.
- Clinical Experience Accumulation: In the Expanded Access Program, 14 patients with non-active secondary progressive multiple sclerosis received nasal foralumab, contributing 30.7 patient-years of exposure, further validating the drug's tolerability and efficacy.
- Research Progress: Tiziana's Phase 2 clinical trial is expected to read out results in 2026, and if successful, it will lay the groundwork for the market introduction of intranasal foralumab, enhancing the company's competitiveness in the biopharmaceutical sector.
- Market Demand Opportunity: The FDA's denial of Sanofi's tolebrutinib highlights the need for safe therapeutic options, and Tiziana's research findings may gain increased attention in this context, potentially boosting market acceptance of its products.
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Analyst Views on TLSA
About TLSA
Tiziana Life Sciences Ltd. is a United Kingdom-based clinical-stage biotechnology company that specializes in developing transformative therapies for neurodegenerative and neuroinflammatory diseases. The Company’s clinical pipeline includes drug assets for secondary progressive multiple sclerosis, Alzheimer’s, and ALS. Its lead immunotherapeutic candidate, Foralumab (TZLS-401), is being developed for Non-Active Secondary Progressive Multiple Sclerosis, Alzheimer’s and other CNS indications. Its Anti-IL-6R mAb (TZLS-501), a fully human mAb, binds to both membrane-bound and soluble forms of IL-6R, an inflammatory cytokine driving chronic inflammation associated with autoimmune and cancer, reducing circulating levels of the IL-6 cytokine. Its oncology product candidate, Milciclib, is a combination therapy for the treatment of refractory solid tumors (being cancers which are non-responsive or become resistant to treatment), especially non-small cell lung cancer (NSCLC).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Tiziana Life Sciences Publishes Intranasal Foralumab Study, Highlighting Efficacy Potential
- Clinical Study Results: Tiziana Life Sciences' intranasal foralumab clinical study has been published in Neurology Neuroimmunology & Neuroinflammation, confirming the therapy's potential for non-active secondary progressive multiple sclerosis patients, particularly those worsening despite prior treatments.
- Study Design and Findings: The open-label trial evaluated intranasal foralumab in 10 na-SPMS patients, showing improvements in clinical symptoms for several patients, favorable biomarker shifts indicating reduced inflammation, and a well-tolerated safety profile with no major concerns reported.
- Advantages of Delivery Route: The intranasal delivery method aims to engage the immune system through mucosal pathways, potentially offering a safer and more targeted treatment option compared to systemic immunosuppression, which Tiziana positions as a differentiator in autoimmune disease therapy.
- Future Development Plans: With peer-reviewed validation, Tiziana plans to advance intranasal foralumab through further clinical development, expecting top-line data from an ongoing randomized, double-blind, placebo-controlled Phase 2 trial in na-SPMS in the first half of 2026, while exploring broader applications in neuroinflammatory and autoimmune conditions.
See More
Tiziana Life Sciences Publishes Positive Study Results for Intranasal Foralumab in MS Patients
- Publication of Results: Tiziana Life Sciences has published an open-label study on intranasal foralumab for non-active secondary progressive multiple sclerosis (na-SPMS) in the journal Neurology Neuroimmunology & Neuroinflammation, marking a significant milestone that highlights the therapy's potential in treatment.
- Positive Patient Outcomes: Among ten patients treated with nasal foralumab, all showed stabilization of Expanded Disability Status Scale (EDSS) scores, with three out of four patients treated for 12 months demonstrating improvement, indicating the therapy's clinical effectiveness.
- High Safety Profile: No serious or severe treatment-related adverse events were reported during the study, further validating the safety of nasal foralumab and enhancing its appeal as a treatment option for multiple sclerosis.
- Biomarker Discoveries: TSPO-PET imaging revealed significant reductions in microglial activation, and single-cell RNA sequencing demonstrated sustained increases in regulatory T cells and TGFβ expression, supporting the unique immunomodulatory mechanism of nasal foralumab and offering new hope for patients.
See More
Tiziana Life Sciences Closes Direct Offering of 7.04 Million Shares, Raising $8.8 Million
- Successful Financing: Tiziana Life Sciences has closed a direct offering of 7.04 million ordinary shares at $1.25 per share, raising a total of $8.8 million to support its upcoming clinical trials.
- Executive Purchases: CEO Ivor Elrifi purchased 2.4 million shares in this offering, increasing his total holdings to 2.75 million shares, reflecting strong confidence in the company's future.
- Warrant Incentives: Each subscriber will receive a warrant to purchase new ordinary shares at $1.50, potentially generating an additional $10.56 million, which enhances the company's financial flexibility.
- Clinical Trial Advancement: The proceeds from this offering will fund Tiziana's Phase 2 trials for na-SPMS and MSA, expected to provide critical data supporting the company's innovations in neuroimmunotherapy.
See More
Tiziana Life Sciences Closes $8.8 Million Direct Offering of 7.04 Million Shares
- Successful Financing: Tiziana Life Sciences has closed a direct offering of 7.04 million ordinary shares at $1.25 per share, raising a total of $8.8 million to support its upcoming clinical trials.
- Executive Purchases: CEO Ivor Elrifi purchased 2.4 million shares in this offering, increasing his total holdings to 2,757,848 shares, reflecting strong confidence in the company's future prospects.
- Warrant Incentives: Each subscriber will receive a warrant to purchase new ordinary shares at $1.50 until July 16, 2026, potentially generating an additional $10.56 million in gross proceeds for the company.
- Advancing Clinical Trials: The proceeds from this offering will fund Tiziana's Phase 2 trials for na-SPMS and MSA, which are expected to yield significant clinical data, enhancing the market potential of its biopharmaceutical products.
See More
Tiziana Life Sciences (TLSA) Completes $8M Direct Offering with Strong Management Participation
- Successful Direct Offering: Tiziana Life Sciences completed a best-efforts registered direct offering of 6.4 million ordinary shares at $1.25 per share, raising gross proceeds of $8 million, demonstrating the company's flexibility in financing and management's confidence.
- Management Participation: CEO Ivor Elrifi purchased 2.4 million shares, while founder and executive chairman Gabriele Cerrone acquired 1.6 million shares through an affiliated entity, indicating strong confidence from executives in the company's future.
- Clear Use of Proceeds: The funds raised will be used to complete Phase 2 clinical trials in na-SPMS and MSA and support top-line data readouts, which are expected to positively impact the company's future market performance.
- Negative Market Reaction: Despite the successful fundraising, Tiziana Life Sciences shares fell 7% in premarket trading, reflecting market concerns about the company's short-term outlook.
See More
Plus Therapeutics Prices Public Offering, Raising $15 Million
- Financing Update: Plus Therapeutics announced the pricing of 39,473,684 units at $0.38 each, expecting to raise approximately $15 million, which will provide fresh capital to advance its precision diagnostics and radiopharmaceutical programs targeting central nervous system cancers.
- Market Performance: Connect Biopharma's stock rose 5.96% to $2.31 without any new news, reflecting ongoing investor interest in its lead candidate rademikibart's new mechanism of action data and strategic priorities for 2026.
- Sector Momentum: ABVC BioPharma's shares increased by 3.37% to $2.15, suggesting that investor interest may be driven by broader momentum in the biotech sector despite the absence of new corporate updates.
- Clinical Progress: Traws Pharma's stock rose 2.82% to $1.82 following its announcement of filing a U.S. IND application for tivoxavir marboxil, further supporting investor optimism around the company's pipeline.
See More
Tiziana Life Sciences Publishes Intranasal Foralumab Study, Highlighting Efficacy Potential
- Clinical Study Results: Tiziana Life Sciences' intranasal foralumab clinical study has been published in Neurology Neuroimmunology & Neuroinflammation, confirming the therapy's potential for non-active secondary progressive multiple sclerosis patients, particularly those worsening despite prior treatments.
- Study Design and Findings: The open-label trial evaluated intranasal foralumab in 10 na-SPMS patients, showing improvements in clinical symptoms for several patients, favorable biomarker shifts indicating reduced inflammation, and a well-tolerated safety profile with no major concerns reported.
- Advantages of Delivery Route: The intranasal delivery method aims to engage the immune system through mucosal pathways, potentially offering a safer and more targeted treatment option compared to systemic immunosuppression, which Tiziana positions as a differentiator in autoimmune disease therapy.
- Future Development Plans: With peer-reviewed validation, Tiziana plans to advance intranasal foralumab through further clinical development, expecting top-line data from an ongoing randomized, double-blind, placebo-controlled Phase 2 trial in na-SPMS in the first half of 2026, while exploring broader applications in neuroinflammatory and autoimmune conditions.
See More
Tiziana Life Sciences Publishes Positive Study Results for Intranasal Foralumab in MS Patients
- Publication of Results: Tiziana Life Sciences has published an open-label study on intranasal foralumab for non-active secondary progressive multiple sclerosis (na-SPMS) in the journal Neurology Neuroimmunology & Neuroinflammation, marking a significant milestone that highlights the therapy's potential in treatment.
- Positive Patient Outcomes: Among ten patients treated with nasal foralumab, all showed stabilization of Expanded Disability Status Scale (EDSS) scores, with three out of four patients treated for 12 months demonstrating improvement, indicating the therapy's clinical effectiveness.
- High Safety Profile: No serious or severe treatment-related adverse events were reported during the study, further validating the safety of nasal foralumab and enhancing its appeal as a treatment option for multiple sclerosis.
- Biomarker Discoveries: TSPO-PET imaging revealed significant reductions in microglial activation, and single-cell RNA sequencing demonstrated sustained increases in regulatory T cells and TGFβ expression, supporting the unique immunomodulatory mechanism of nasal foralumab and offering new hope for patients.
See More
Tiziana Life Sciences Closes Direct Offering of 7.04 Million Shares, Raising $8.8 Million
- Successful Financing: Tiziana Life Sciences has closed a direct offering of 7.04 million ordinary shares at $1.25 per share, raising a total of $8.8 million to support its upcoming clinical trials.
- Executive Purchases: CEO Ivor Elrifi purchased 2.4 million shares in this offering, increasing his total holdings to 2.75 million shares, reflecting strong confidence in the company's future.
- Warrant Incentives: Each subscriber will receive a warrant to purchase new ordinary shares at $1.50, potentially generating an additional $10.56 million, which enhances the company's financial flexibility.
- Clinical Trial Advancement: The proceeds from this offering will fund Tiziana's Phase 2 trials for na-SPMS and MSA, expected to provide critical data supporting the company's innovations in neuroimmunotherapy.
See More
Tiziana Life Sciences Closes $8.8 Million Direct Offering of 7.04 Million Shares
- Successful Financing: Tiziana Life Sciences has closed a direct offering of 7.04 million ordinary shares at $1.25 per share, raising a total of $8.8 million to support its upcoming clinical trials.
- Executive Purchases: CEO Ivor Elrifi purchased 2.4 million shares in this offering, increasing his total holdings to 2,757,848 shares, reflecting strong confidence in the company's future prospects.
- Warrant Incentives: Each subscriber will receive a warrant to purchase new ordinary shares at $1.50 until July 16, 2026, potentially generating an additional $10.56 million in gross proceeds for the company.
- Advancing Clinical Trials: The proceeds from this offering will fund Tiziana's Phase 2 trials for na-SPMS and MSA, which are expected to yield significant clinical data, enhancing the market potential of its biopharmaceutical products.
See More
Tiziana Life Sciences (TLSA) Completes $8M Direct Offering with Strong Management Participation
- Successful Direct Offering: Tiziana Life Sciences completed a best-efforts registered direct offering of 6.4 million ordinary shares at $1.25 per share, raising gross proceeds of $8 million, demonstrating the company's flexibility in financing and management's confidence.
- Management Participation: CEO Ivor Elrifi purchased 2.4 million shares, while founder and executive chairman Gabriele Cerrone acquired 1.6 million shares through an affiliated entity, indicating strong confidence from executives in the company's future.
- Clear Use of Proceeds: The funds raised will be used to complete Phase 2 clinical trials in na-SPMS and MSA and support top-line data readouts, which are expected to positively impact the company's future market performance.
- Negative Market Reaction: Despite the successful fundraising, Tiziana Life Sciences shares fell 7% in premarket trading, reflecting market concerns about the company's short-term outlook.
See More
Plus Therapeutics Prices Public Offering, Raising $15 Million
- Financing Update: Plus Therapeutics announced the pricing of 39,473,684 units at $0.38 each, expecting to raise approximately $15 million, which will provide fresh capital to advance its precision diagnostics and radiopharmaceutical programs targeting central nervous system cancers.
- Market Performance: Connect Biopharma's stock rose 5.96% to $2.31 without any new news, reflecting ongoing investor interest in its lead candidate rademikibart's new mechanism of action data and strategic priorities for 2026.
- Sector Momentum: ABVC BioPharma's shares increased by 3.37% to $2.15, suggesting that investor interest may be driven by broader momentum in the biotech sector despite the absence of new corporate updates.
- Clinical Progress: Traws Pharma's stock rose 2.82% to $1.82 following its announcement of filing a U.S. IND application for tivoxavir marboxil, further supporting investor optimism around the company's pipeline.
See More
