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Tiziana Life Sciences (TLSA)

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Research analysts covering Tiziana Life Sciences.

Recent press releases and 8-K filings for TLSA.

Tiziana Life Sciences announces peer-reviewed publication of intranasal foralumab clinical study results
TLSA
New Projects/Investments
  • Tiziana Life Sciences announced the peer-reviewed publication of positive clinical study results for its lead candidate, intranasal foralumab, in patients with non-active secondary progressive multiple sclerosis (na-SPMS).
  • The open-label study, published in Neurology Neuroimmunology & Neuroinflammation, reported no serious or severe treatment-related adverse events and demonstrated stabilization of Expanded Disability Status Scale (EDSS) scores in all ten patients, alongside significant reductions in microglial activation.
  • The company is currently conducting a Phase 2 trial for intranasal foralumab in na-SPMS, with top-line data anticipated in the first half of 2026.
Jan 20, 2026, 4:15 PM
Tiziana Life Sciences Closes $8.8 Million Registered Direct Offering
TLSA
New Projects/Investments
  • Tiziana Life Sciences Ltd. announced the closing of an oversubscribed registered direct offering on January 16, 2026, raising $8.8 million in gross proceeds from the sale of 7,040,000 ordinary shares at $1.25 per share.
  • The offering included warrants for additional ordinary shares at $1.50, potentially generating up to an additional $10.56 million in gross proceeds.
  • The proceeds from this offering are designated to complete the company's Phase 2 na-SPMS and MSA clinical trials and achieve top-line data readouts.
  • The offering was made to members of senior management and existing shareholders, with CEO Ivor Elrifi purchasing 2,400,000 ordinary shares and Executive Chairman Gabriele Cerrone purchasing 1,600,000 ordinary shares.
Jan 16, 2026, 8:12 PM
Tiziana Life Sciences Announces Registered Direct Offering
TLSA
  • Tiziana Life Sciences Ltd. announced a registered direct offering of 6,400,000 ordinary shares at $1.25 per ordinary share, expected to generate $8.0 million in gross proceeds.
  • For every ordinary share subscribed, participants will receive one warrant entitling them to subscribe for one new ordinary share at $1.50 up to July 16, 2026, potentially resulting in additional gross proceeds of up to approximately $9.6 million.
  • The offering, expected to close on January 16, 2026, was conducted without an underwriter and was made to members of senior management and existing shareholders, including significant participation from the CEO and Executive Chairman.
  • The proceeds from this offering are intended to enable the company to complete its Phase 2 na-SPMS and MSA clinical trials and achieve top-line data readouts in both trials.
Jan 16, 2026, 12:00 PM
Tiziana Life Sciences Files Annual Safety Report for Intranasal Foralumab with FDA
TLSA
New Projects/Investments
  • Tiziana Life Sciences submitted its seventh annual Development Safety Update Report (DSUR) for intranasal foralumab to the U.S. Food and Drug Administration (FDA), covering the period from September 21, 2024, to September 2, 2025.
  • The report indicates no drug-related serious adverse events after a cumulative exposure of 37.4 patient-years, highlighting the safety and tolerability data profile of intranasal foralumab.
  • This safety profile applies to the treatment of neuroinflammatory diseases, including non-active secondary progressive multiple sclerosis (naSPMS), multiple system atrophy, and Alzheimer’s Disease (AD).
  • The company's CEO emphasized the need for safe therapies, contrasting foralumab's safety with the FDA's December 23, 2025, denial of Sanofi's tolebrutinib for nrSPMS due to toxicity.
  • Results from the Phase 2 foralumab trial in naSPMS are anticipated to be available in 2026.
Dec 29, 2025, 1:00 PM
Tiziana Life Sciences Announces Executive Chairman's Share Acquisition
TLSA
  • On December 19, 2025, Tiziana Life Sciences' Executive Chairman, Gabriele Cerrone, through Panetta Partners Limited, purchased an additional 97,687 common shares.
  • This acquisition increased his total beneficial holding to 43,374,830 common shares, representing 36.08% of the company's issued share capital.
Dec 19, 2025, 6:20 PM
Tiziana Life Sciences to Ring Nasdaq Closing Bell
TLSA
New Projects/Investments
  • Tiziana Life Sciences' Founder and Executive Chairman, Gabriele Cerrone, will ring the Nasdaq Closing Bell on December 17, 2025, to celebrate the company's ongoing advancements in innovative treatments.
  • The celebration highlights the company's lead candidate, intranasal foralumab, a fully human anti-CD3 monoclonal antibody, which utilizes a nasal delivery approach to target neurodegenerative and inflammatory diseases such as multiple sclerosis, Alzheimer's disease, and ALS.
  • Recent achievements for the company include the dosing of the first patient in its Phase 2 Alzheimer's trial and expansions in other key studies.
  • Intranasal foralumab is currently being studied in a Phase 2a randomized, double-blind, placebo-controlled trial for non-active secondary progressive multiple sclerosis and has shown improvement or stability in 14 patients with Non-Active Secondary Progressive Multiple Sclerosis in an Expanded Access Program.
Dec 17, 2025, 3:33 PM
Tiziana Life Sciences Doses First Patient in Phase 2 Alzheimer's Clinical Trial
TLSA
New Projects/Investments
  • Tiziana Life Sciences Ltd. (TLSA) has dosed the first patient with intranasal foralumab in its Phase 2 randomized, placebo-controlled clinical trial for early Alzheimer's disease (AD), as announced on December 17, 2025.
  • The trial evaluates intranasal foralumab as both a monotherapy and in combination with FDA-approved anti-amyloid therapies, such as lecanemab or donanemab.
  • Primary endpoints for the study include neuroinflammation measured by TSPO-PET imaging, cognitive function, and changes in amyloid and tau biomarkers.
  • Interim data from the trial are anticipated in 2026.
Dec 17, 2025, 1:45 PM
Tiziana Life Sciences Withdraws Proposed Public Offering
TLSA
  • Tiziana Life Sciences Ltd. announced the withdrawal of its proposed public offering of common shares on December 15, 2025.
  • The company stated that the withdrawal was due to "market conditions".
Dec 15, 2025, 12:30 PM
Tiziana Life Sciences begins enrollment for Phase 2 Alzheimer's trial
TLSA
New Projects/Investments
  • Tiziana Life Sciences has begun enrollment in its Phase 2 randomized, placebo-controlled early Alzheimer’s clinical trial and plans to dose the first patient next week.
  • The trial will evaluate intranasal foralumab as both a monotherapy and in combination with FDA-approved anti-amyloid therapies (lecanemab or donanemab) for patients with early Alzheimer’s disease.
  • This clinical trial is supported by new evidence demonstrating persistent and widespread microglial activation (neuroinflammation) in Alzheimer's patients, even after treatment with anti-amyloid therapies.
  • Intranasal foralumab is a fully human anti-CD3 monoclonal antibody designed to induce regulatory T cells and suppress pathological neuroinflammation, aiming to address the inflammatory component of Alzheimer's disease.
Dec 12, 2025, 7:10 PM
Tiziana Life Sciences Plans Spin-Out of IL-6 Asset
TLSA
New Projects/Investments
  • Tiziana Life Sciences Ltd. (TLSA) announced its intent to spin out TZLS-501, its fully human anti-IL-6 receptor monoclonal antibody asset, into a new, separate publicly traded company.
  • This strategic move aims to enhance strategic focus and unlock shareholder value, with existing Tiziana shareholders receiving shares in the new entity.
  • The decision is partly driven by heightened industry interest in the IL-6 pathway, exemplified by Novartis' recent $1.4 billion acquisition of an IL-6 inhibitor.
  • The transaction is subject to shareholder approval and meeting listing criteria, with the record date to be announced in the coming weeks.
Dec 2, 2025, 12:00 PM