Tiziana Life Sciences Ltd Com SEC Filings

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.

Tiziana Life Sciences Ltd filed a Form 6-K announcing positive preclinical results for its lead candidate, intranasal foralumab, in a Long COVID mouse model. The study showed that nasal anti-CD3 treatment reduced neuroinflammation, increased regulatory T cells in the brain, restored hippocampal neurogenesis, and improved short‑term memory.

The work, led by researchers at Yale and Brigham and Women’s/Harvard, used a mild respiratory SARS‑CoV‑2 model mimicking Long COVID without direct brain infection and included human observational data showing lower circulating Tregs in Long COVID patients. Tiziana highlights these findings as mechanistic support for intranasal foralumab, which has already shown favorable safety and signs of clinical benefit in an expanded access program and is being tested in a Phase 2a trial in non‑active secondary progressive multiple sclerosis.

Tiziana Life Sciences Ltd has reported that a late-breaking poster on its Phase 2a study of intranasal foralumab in Multiple System Atrophy (MSA) has been accepted for presentation at the 7th World Parkinson Congress in Phoenix, Arizona, taking place May 24-27, 2026.

The poster will describe the ongoing TILS-025 trial, the first clinical investigation of intranasal anti-CD3 therapy in MSA, an aggressive neurodegenerative disorder with no approved disease-modifying treatments. The open-label study enrolls up to 10 subjects aged 30–85 who receive intranasal foralumab 50 μg per dose for 6 months.

Key measures include changes in microglial activation via [F-18]PBR06 TSPO PET imaging and MDS-UMSARS scores, along with MRI-based brain atrophy, autonomic function, quality-of-life outcomes, and blood and CSF immune biomarkers. The company also highlights ongoing intranasal foralumab programs in non-active secondary progressive multiple sclerosis and prior evidence of reduced neuroinflammation in other neurological conditions.

Tiziana Life Sciences Ltd filed a Form 6-K to share positive preclinical data on its nasal anti-CD3 approach, using intranasal foralumab, as a potential way to address neuroinflammation linked to aging and associated cognitive decline. In a preclinical aging model, nasal anti-CD3 reversed key aspects of brain aging and improved cognition.

The company explains that intranasal foralumab, a fully human anti-CD3 monoclonal antibody, stimulates regulatory T cells to reduce neuroinflammation. Tiziana notes that 14 patients with non-active secondary progressive multiple sclerosis in an expanded access program showed either disease improvement or stability within six months, and intranasal foralumab is also being evaluated in a Phase 2a trial and other neurodegenerative indications.

Tiziana Life Sciences Ltd director and more-than-10% owner Gabriele M. Cerrone filed an initial ownership report showing substantial holdings in the company’s common stock and options. The filing lists direct ownership of 44,654,830 shares of common stock.

It also shows options over 1,629,702 shares of common stock at an exercise price of $0.88 per share expiring on May 6, 2028, plus four option positions over 250,000 underlying shares each at an exercise price of $0.71 per share expiring on May 3, 2034. According to a footnote, these options are exercisable upon the achievement of certain performance conditions.