Tiziana Life Sciences Ltd. filings document foreign-private-issuer material-event disclosures for a clinical-stage biotechnology company developing intranasal foralumab, a fully human anti-CD3 monoclonal antibody. The company’s Form 6-K reports furnish press-release exhibits on clinical and preclinical data, biomarker findings, peer-reviewed study publications, conference presentations, and program activity in neuroinflammatory and neurodegenerative diseases.
The filing record also includes capital-structure disclosures tied to registered direct offerings of ordinary shares and warrants, together with governance and security-structure information relevant to the company’s Nasdaq-listed ordinary shares and foreign issuer reporting framework.
Tiziana Life Sciences Ltd (TLSA) said members of its management and business development teams will attend MSToronto2026, the 10th joint ACTRIMS-ECTRIMS meeting, in Toronto from October 21 through October 23, 2026. Company representatives will be available to discuss clinical programs in multiple sclerosis, Alzheimer’s disease, multiple system atrophy and amyotrophic lateral sclerosis, as well as scientific collaboration and business development.
Tiziana reported that 14 patients with non-active secondary progressive multiple sclerosis have been dosed in an open-label expanded-access program for intranasal foralumab, with improvement or stability of disease seen within 6 months in all patients. The treatment is also being studied in a Phase 2a randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in that condition, alongside additional Phase 2 trials in Alzheimer’s disease and multiple system atrophy.
Tiziana Life Sciences Ltd (TLSA) reported interim results for the six months ended June 30, 2026, and a pipeline update. Total comprehensive loss was $12.365 million versus $5.293 million in first-half 2025. Cash and cash equivalents were $3.178 million at June 30, 2026, versus $4.010 million at December 31, 2025; operating activities used $7.356 million and financing activities generated $6.511 million.
The directors said projections show Tiziana will not be able to meet liabilities as they fall due within the next 12 months from issuance of the statements. They identified a material uncertainty that may cast significant doubt on the company’s ability to continue as a going concern, while preparing accounts on that basis; steps included exploring deferred payments on existing liabilities, working-capital cost reductions and raising additional equity.
Tiziana reported completed Phase 2 enrollment for non-active secondary progressive multiple sclerosis, with the last patient receiving a first dose in July 2026; MSA dosing and early Alzheimer’s enrollment were ongoing. PET analysis in the first two treated MSA patients reported up to approximately 35% reduction in standardized uptake value and approximately 24% reduction in standardized uptake value ratio. On July 16, 2026, Tiziana agreed to extend the exercise period of 7,040,000 January 2026 warrants by six months, to January 16, 2027.
Tiziana Life Sciences Ltd (TLSA) announced that the last patient has begun dosing in its Phase 2 randomized, placebo-controlled trial of intranasal foralumab for early/mild Alzheimer’s disease, completing enrollment and starting dosing for all participants. The study evaluates foralumab alone and alongside FDA-approved lecanemab or donanemab; topline data are anticipated in Q1 2027.
The study assesses safety and tolerability and potential efficacy. Separately, Tiziana reports that 14 patients with non-active secondary progressive multiple sclerosis in an open-label expanded-access program had either improvement or stability of disease within 6 months.
Tiziana Life Sciences Ltd (TLSA) submitted a request to the U.S. Food and Drug Administration for Orphan Drug Designation for intranasal foralumab to treat multiple system atrophy (MSA). The FDA grants the designation to drugs or biologics intended for rare diseases or conditions affecting fewer than 200,000 people in the United States. MSA currently has no FDA-approved disease-modifying therapies.
Tiziana is also evaluating intranasal foralumab in a Phase 2a open-label trial for MSA.
Tiziana Life Sciences Ltd (TLSA) CEO Ivor Elrifi reported the exercise/conversion and disposition of 1,050,000 restricted stock units on August 15, 2026. The transactions also report acquisition of 1,050,000 common shares held indirectly through a trust. Each RSU is a contingent right to one common share; the units were granted on August 15, 2024. Reported post-transaction positions were 2,100,000 RSUs and 5,843,684 common shares held indirectly through a trust.
Tiziana Life Sciences Ltd (TLSA) announced that the first three participants received their first dose of intranasal foralumab in the Phase 2a Healey ALS MyMatch BANYAN trial, which evaluates the candidate in people living with ALS. Tiziana sponsors the study, which is co-funded by the ALS Association through its Hoffman ALS Clinical Trial Awards Program.
Separately, Tiziana reports that 14 patients with non-active secondary progressive multiple sclerosis have been dosed in an open-label Expanded Access Program; improvement or stable disease was seen within six months in all patients.
Tiziana Life Sciences Ltd (TLSA) reports that the last patient has completed the last visit in its Phase 2a INFORM-MS clinical trial of intranasal foralumab in non-active Secondary Progressive Multiple Sclerosis (na-SPMS).
The randomized, double-blind, placebo-controlled study enrolled 48 patients across three cohorts at multiple U.S. sites and evaluated two doses of intranasal foralumab versus placebo over 12 weeks. The primary endpoint is change in microglial activation measured by PET imaging, with secondary endpoints including EDSS and MFIS. Tiziana expects to lock the database this week and announce 12-week topline data in October. All participants can enter a six-month open-label extension to receive intranasal foralumab, and 14 na-SPMS patients have already been treated in an Expanded Access Program, where the company reports improvement or stability of disease within six months in all patients.
Tiziana Life Sciences Ltd (TLSA) announced a Memorandum of Understanding with King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, the Ministry of National Guard – Health Affairs, and the Foundation for Neurologic Diseases to collaborate on a clinical trial in multiple sclerosis.
The planned study will test Tiziana’s proprietary intranasal foralumab in combination with existing anti-CD20 therapy in relapsing-remitting multiple sclerosis patients who respond poorly to anti-CD20 alone, building on three prior clinical studies where intranasal foralumab reduced neuroinflammation. Tiziana highlights ongoing programs, including an expanded access program in non-active secondary progressive MS treating 14 patients with improvement or stability at six months, a Phase 2a randomized trial in na-SPMS, and additional Phase 2 trials in Alzheimer’s disease and multiple system atrophy, with blinded na-SPMS Phase 2 results expected in October.
Tiziana Life Sciences Ltd (TLSA) reports that a scientific poster on its Phase 2a BANYAN clinical trial of intranasal foralumab in amyotrophic lateral sclerosis (ALS) is being presented at ALS Nexus 2026 in Orlando. The BANYAN trial is a 3:1 randomized, placebo-controlled, multicenter Phase 2a study under the Healey ALS MyMatch program, designed to evaluate safety, biomarkers of immune modulation and neuroinflammation, and early clinical signals in people living with ALS. Tiziana highlights the role of regulatory T cells in ALS biology and positions intranasal foralumab, a fully human anti-CD3 monoclonal antibody, as a non‑invasive immunomodulatory approach. The company also notes that 14 patients with non‑active secondary progressive multiple sclerosis have been dosed with intranasal foralumab in an open-label Expanded Access program, with either improvement or stability of disease within 6 months.
Tiziana Life Sciences Ltd insider Gabriele M. Cerrone, a director and ten percent owner, indirectly purchased 42,357 shares of common stock on July 21, 2026 at $0.99 per share, through Panetta Partners Limited. Following this open-market purchase, indirect holdings total 44,814,587 shares. The Form 4/A corrects the earliest transaction date and transaction code for this purchase; no other reported transactions are changed.