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Tiziana Life Sciences Ltd. develops intranasal foralumab, a fully human anti-CD3 monoclonal antibody, as a clinical-stage biotechnology company focused on neuroinflammatory and neurodegenerative diseases. News for TLSA centers on clinical and preclinical data for intranasal anti-CD3 therapy, including non-active secondary progressive multiple sclerosis, Multiple System Atrophy, Alzheimer’s disease, ALS, Long COVID-associated neuroinflammation, and age-related cognitive decline.
Company updates also cover biomarker work involving CSF proteomics, TSPO-PET and microglial activation, peer-reviewed publications, scientific conference presentations, expanded-access observations, and financing actions such as registered direct offerings of ordinary shares and warrants.
Tiziana Life Sciences (Nasdaq: TLSA) announced that Executive Chairman and Founder Gabriele Cerrone will ring the Nasdaq Closing Bell in Times Square on December 17, 2025 from 3:45 PM to 4:15 PM ET. The ceremony celebrates the company's progress advancing intranasal foralumab, a fully human anti-CD3 monoclonal antibody delivered nasally to target neurodegenerative and inflammatory diseases including multiple sclerosis, Alzheimer's disease, and ALS.
The company noted recent pipeline progress, including dosing the first patient in its Phase 2 Alzheimer's trial, and provided livestream links for the event.
Tiziana Life Sciences (Nasdaq: TLSA) announced that the first patient was dosed on December 17, 2025 in its randomized, placebo-controlled Phase 2 trial of intranasal foralumab for early Alzheimer’s disease.
The trial will evaluate foralumab as monotherapy and combined with FDA-approved anti-amyloid therapies lecanemab (Leqembi) or donanemab, and is supported by TSPO-PET imaging data showing persistent microglial activation after amyloid reduction. The program tests an immunomodulatory approach targeting residual neuroinflammation with intranasal anti-CD3 foralumab; enrollment will continue and clinical outcomes are pending.
Tiziana Life Sciences (Nasdaq: TLSA) announced on December 15, 2025 that its Chief Executive Officer, Ivor Elrifi, purchased 163,400 shares of Tiziana common stock in the open market.
Following this transaction, the CEO's total purchased shares amount to 357,848. The purchase was executed on the open market and reflects an insider buy by the company's chief executive.
Tiziana Life Sciences (Nasdaq: TLSA) announced on Dec 15, 2025 that it has withdrawn its proposed public offering of common shares. The company said the withdrawal was made due to market conditions. The release also states that it does not constitute an offer to sell or a solicitation to buy securities in any jurisdiction prior to required registration or qualification.
Tiziana Life Sciences (Nasdaq: TLSA) announced on Dec 12, 2025 that enrolment has begun in its Phase 2 randomized, placebo-controlled early Alzheimer’s trial and the company expects to dose the first patient next week. The study will test intranasal foralumab as monotherapy and combined with FDA-approved anti-amyloid therapies lecanemab or donanemab.
Baseline cognitive testing, fluid biomarkers and TSPO-PET imaging were completed in initial participants; new TSPO-PET evidence showed persistent, widespread microglial activation in an Alzheimer’s patient despite treatment with lecanemab, supporting the trial rationale to target residual neuroinflammation.
Tiziana Life Sciences (Nasdaq: TLSA) intends to spin out its fully human anti-IL-6 receptor program TZLS-501 into a separately listed, immunology-focused company and will distribute shares in specie to Tiziana shareholders at a record date to be announced. TZLS-501 targets both membrane-bound and soluble IL-6R and was advanced for development due to heightened industry interest in IL-6 therapeutics, noted alongside Novartis' $1.4 billion acquisition of Tourmaline Bio.
The transaction requires shareholder approval and meeting listing criteria; TZLS-501 remains a Tiziana asset until approvals are obtained.
Tiziana Life Sciences (Nasdaq: TLSA) announced on November 25, 2025 that its Phase 2 trial of intranasal foralumab in amyotrophic lateral sclerosis (ALS) was accepted into the Healey ALS MyMatch Program at the Sean M. Healey & AMG Center for ALS at Mass General Brigham.
The study, supported by a competitive grant from the ALS Association, will be led by Principal Investigators Suma Babu and James Berry and will enroll at multiple rapid-enrolling U.S. centers within the NEALS consortium. Successful investigational agents in MyMatch may advance to the HEALEY ALS Platform Trial or to standalone Phase 3 trials. The trial will use nasal immunology, blood and spinal fluid markers, cellular assays, and advanced brain imaging to evaluate foralumab’s effect on regulatory T cells and CNS inflammation.
Tiziana Life Sciences (Nasdaq: TLSA) said its senior leadership will present a corporate overview at the Jefferies London Healthcare Conference on Wednesday, November 19, 2025. The presentation is scheduled for 12:30 p.m.–12:55 p.m. GMT and will run 25 minutes.
CEO Ivor Elrifi and COO/CFO Keeren Shah will discuss the company’s pipeline and recent clinical milestones, including an update on lead candidate intranasal foralumab, a fully human anti‑CD3 monoclonal antibody in clinical development for neurodegenerative diseases such as non‑active SPMS, Alzheimer’s disease, MSA, and ALS. Management will be available for one‑on‑one meetings via the conference portal or investor relations.
Tiziana Life Sciences (Nasdaq: TLSA) will present at BIO-Europe 2025 in Vienna on November 3–5, 2025, where management led by CEO Ivor Elrifi will hold one-on-one partnering meetings with biopharma executives and investors.
The presentation will highlight Tiziana’s intranasal foralumab, a fully human anti-CD3 monoclonal antibody in clinical development, and the company’s nasal delivery platform aimed at improving efficacy, safety, and tolerability versus IV dosing. Ongoing programs include Phase 2 trials in non-active secondary progressive MS (na-SPMS) and Multiple System Atrophy (MSA); Phase 2 studies in early Alzheimer’s disease and amyotrophic lateral sclerosis (ALS) are planned to commence.
BIO-Europe 2025 is expected to attract over 5,700 delegates from 60+ countries, offering partnering opportunities to advance Tiziana’s immunomodulation pipeline.
Tiziana Life Sciences (NASDAQ:TLSA), a biotechnology company focused on immunomodulation therapies, has been invited to the J.P. Morgan Asset Management Life Science Innovation Forum (LSIF) 2025 in Riyadh, Saudi Arabia. The event will take place on October 1-2, 2025 at the King Saud bin Abdulaziz University for Health Sciences Conference Center.
The forum aims to accelerate life science research commercialization and strengthen the biotechnology value chain in Saudi Arabia. The company will have the opportunity to present its clinical pipeline, including its lead candidate intranasal foralumab, a fully human anti-CD3 monoclonal antibody, to potential investors and strategic partners.