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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.
Tiziana Life Sciences reported new biomarker data for its lead candidate, intranasal foralumab, in non-active secondary progressive multiple sclerosis (na-SPMS) with progression independent of relapse activity (PIRA). In 10 patients, 14 paired assessments linked treatment to reduced cerebrospinal fluid (CSF) inflammation, increased neuroprotective proteomic pathways, and reduced microglial activation on [F-18]PBR06-PET scans.
Investigators described this as the first direct connection between PET changes and favorable CSF shifts during nasal foralumab treatment in this population, supporting its role in targeting smoldering CNS inflammation. Tiziana is running an ongoing randomized, double-blind, placebo-controlled Phase 2a trial in na-SPMS, with top-line data expected in the first half of 2026, and has dosed 14 expanded-access patients, all showing disease improvement or stability within 6 months.
Tiziana Life Sciences Ltd. is offering 8,800,000 common shares at $1.25 per share on a best efforts basis, with one warrant for each share. Each warrant allows the holder to buy one additional common share at $1.50 until July 16, 2026. The offering would generate gross proceeds of $8,800,000, and the company plans to use the funds, together with existing cash, primarily to complete Phase 2 clinical trials in non-active SPMS and MSA and to support broader development of its lead asset, foralumab.
Common shares outstanding are expected to be 127,259,131 after the offering, up from 118,851,954 as of June 30, 2025. The company highlights that investors will experience immediate dilution, estimating a $1.11 per-share dilution relative to adjusted net tangible book value. Management also notes its status as an emerging growth company and smaller reporting company, ongoing need for additional capital, and the historically volatile trading range of its Nasdaq-listed shares under the symbol TLSA.
Tiziana Life Sciences Ltd. is conducting a primary offering of 8,800,000 common shares at $1.25 per share, with each share paired with a warrant to buy one additional common share at $1.50 until July 16, 2026. The shares trade on Nasdaq under the symbol “TLSA”.
Gross proceeds are expected to be $8.8 million before expenses, and the company plans to use the cash, together with existing funds, mainly to complete its Phase 2 clinical trials in non-active secondary progressive multiple sclerosis (na-SPMS) and multiple system atrophy (MSA), and to support broader development of its lead drug foralumab and general corporate purposes. After the offering, Tiziana expects to have 127,259,131 common shares outstanding, so new investors will experience immediate dilution relative to net tangible book value and could face further dilution if warrants, options, or RSUs are exercised.
Tiziana Life Sciences filed a Form 6-K to highlight the peer-reviewed publication of its open-label study of intranasal foralumab in patients with non-active secondary progressive multiple sclerosis (na-SPMS). The study appears in Neurology Neuroimmunology & Neuroinflammation, a journal of the American Academy of Neurology, and reports comprehensive positive results previously shared on May 6, 2025.
The publication is described as the first na-SPMS study to integrate TSPO-PET imaging, proteomics, and clinical assessments, supporting a novel mechanism for targeting progression independent of relapse activity. Investigators note clinical stabilization, microglial PET findings, and biomarker changes that align with nasal foralumab’s proposed immune-modulating effects without broad systemic immunosuppression.
Foralumab, the only fully human anti-CD3 monoclonal antibody currently in clinical development, has been dosed intranasally in 14 na-SPMS patients under an expanded access program, with improvement or stability within six months in all patients. Tiziana is also running an ongoing randomized, double-blind, placebo-controlled Phase 2 trial in na-SPMS, with top-line data expected in the first half of 2026.