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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 reported that Executive Chairman and Founder Gabriele Cerrone, through Panetta Partners Ltd, purchased 42,357 common shares at $0.99 per share. Following this transaction, his total holding is 44,814,587 common shares, representing 34.93% of issued share capital.
The company highlights its lead candidate, intranasal foralumab, a fully human anti-CD3 monoclonal antibody in development for neuroinflammatory and neurodegenerative diseases. Fourteen patients with non-active secondary progressive multiple sclerosis have been dosed in an Expanded Access Program, with improvement or disease stability within 6 months in all patients, and a Phase 2a randomized, double-blind, placebo-controlled trial is ongoing.
Tiziana Life Sciences reports that the last patient in its Phase 2a INFORM-MS trial has received a first dose of intranasal foralumab for non-active Secondary Progressive Multiple Sclerosis (na-SPMS). This marks full initial dosing in the randomized, double-blind, placebo-controlled study.
The trial will evaluate two intranasal foralumab dose levels versus placebo in up to 48 patients across multiple U.S. centers, using imaging biomarkers and clinical outcomes. The primary endpoint is change in microglial activation measured by PET scans, alongside disability, fatigue, and quality-of-life measures.
Topline data are expected in late Q3 or early Q4 2026 and are planned to be presented at the joint ACTRIMS/ECTRIMS meeting in Toronto in October 2026. Separately, 14 na-SPMS patients in an expanded access program have shown improvement or disease stability within six months after intranasal foralumab treatment.
Tiziana Life Sciences Ltd reported that major shareholder and director Gabriele M. Cerrone indirectly acquired 15,000 shares of common stock as a grant or award. The shares were credited on June 12, 2026 at $1.11 per share via Panetta Partners Limited, bringing his reported indirect holdings to 44,772,230 shares of common stock.
Tiziana Life Sciences Ltd filed a Form 6-K reporting that Executive Chairman and Founder Gabriele Cerrone, via Panetta Partners Ltd, purchased 15,000 common shares at $1.11 per share, increasing his total holding to 44,772,230 shares, or 34.89% of the company’s issued share capital.
The filing also highlights Tiziana’s lead candidate, intranasal foralumab, a fully human anti-CD3 monoclonal antibody in development for non-active secondary progressive multiple sclerosis. Fourteen patients have been treated in an expanded access program, and a Phase 2a randomized, double-blind, placebo-controlled trial is in progress.
Tiziana Life Sciences filed a Form 6-K to announce that it will present at the Jefferies Healthcare Conference in New York City. Chief Executive Officer Ivor Elrifi and Chief Operating and Financial Officer Keeren Shah will give a corporate presentation covering recent clinical and corporate developments.
The company highlights intranasal foralumab, its lead fully human anti-CD3 monoclonal antibody, which is being evaluated in non-active secondary progressive multiple sclerosis, including an expanded access program and an ongoing Phase 2a clinical trial. Management plans to discuss strategic direction and upcoming milestones with institutional investors during the conference.
Tiziana Life Sciences Ltd executive Keeren Rameshchandra Shah, the Chief Operating & Financial Officer, filed an initial Form 3 reporting his beneficial ownership in the company. He holds 2,500 shares of common stock directly, along with multiple option awards over common shares.
These options cover various blocks of common stock at exercise prices of $0.50, $0.57, $0.82, $0.88 and $1.58 per share, with expiration dates ranging from 2030 to 2035. The filing lists these positions as existing holdings rather than new purchases or sales.
Tiziana Life Sciences reports that it has fully enrolled its randomized, double-blind, placebo-controlled Phase 2a clinical trial of intranasal foralumab in patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS). The INFORM-MS study has enrolled 48 patients at U.S. sites to receive one of two doses of intranasal foralumab or placebo over a 12-week treatment period.
Topline data are expected in late Q3 2026 and are planned to be presented at the 10th joint ACTRIMS/ECTRIMS meeting in Toronto in October 2026. After the blinded phase, all participants, including prior placebo recipients, may receive intranasal foralumab in a six-month open-label extension to assess long-term safety and sustained benefit.
The company highlights foralumab as the only fully human anti-CD3 monoclonal antibody currently in clinical development and notes an open-label Expanded Access program in 14 na-SPMS patients, where improvement or disease stability within six months has been observed.
Tiziana Life Sciences reported updated clinical data from its Expanded Access program testing intranasal foralumab in 14 patients with non-active secondary progressive multiple sclerosis. Over roughly one year of follow-up, the therapy remained extremely well tolerated during extended treatment.
Patients showed trends toward stabilization of disability on the Expanded Disability Status Scale and meaningful fatigue improvements on the Modified Fatigue Impact Scale, with 64% achieving a clinically important MFIS score gain. The company notes these findings are based on a small open-label cohort and are not statistically significant, but believes the longer-term trends support continued development of intranasal foralumab in progressive multiple sclerosis.
Tiziana Life Sciences reported early brain imaging results from the first two Multiple System Atrophy (MSA) patients treated with its intranasal anti-CD3 antibody foralumab in an ongoing Phase 2 trial. PET scans showed up to approximately 35% reduction in standardized uptake value and about 24% reduction in standardized uptake value ratio in affected brain regions, including the basal ganglia and cerebellar white matter.
The company notes this is the third indication where intranasal foralumab has shown marked reduction in inflammation on PET scans, alongside previous findings in non-active secondary progressive multiple sclerosis and moderate Alzheimer’s disease. Tiziana plans to continue enrolling MSA patients to further evaluate foralumab’s potential to reduce neuroinflammation.
Tiziana Life Sciences Ltd files its annual Form 20-F, reporting continued clinical-stage development with no approved products and ongoing losses. For the year ended December 31, 2025, the company recorded a net loss of $18.4 million and total operating expenses of $21.1 million.
Cash and cash equivalents were $4.0 million and working capital was a deficit of $2.7 million as of December 31, 2025, with total assets of $11.5 million and shareholders’ equity of $52 thousand. Auditors included a going concern emphasis, citing the need for additional funding despite a subsequent $8.6 million equity raise in January 2026.
The report highlights dependence on lead candidate Foralumab across multiple neuroinflammatory indications, significant clinical, regulatory and manufacturing risks, heavy reliance on third-party CROs and CMOs, and substantial milestone and royalty obligations under key in-licensing agreements.