TLSA News & Events

Tiziana Life Sciences announces positive new biomarker data from a late-breaking poster titled "Nasal foralumab downregulates CSF inflammation and upregulates CSF neuroprotective proteomic pathways which correlate with PBR06-PET imaging in na-SPMS with PIRA," which was presented by investigators from Brigham and Women's Hospital, Boston, MA. Key findings include: Nasal foralumab treatment significantly reduced voxel-wise average PBR06-PET m-GALP z-scores in white matter and global brain regions, confirming decreased microglial activation. CSF proteomics showed downregulation of inflammatory biomarkers and upregulation of neuroprotective proteins. Strong positive correlations were observed between PET m-GALP z-scores and inflammatory CSF proteins. Negative correlations were seen with neuroprotective proteins. These biomarker changes occurred alongside clinical stabilization or improvement, with no serious treatment-related adverse events.

Tiziana Life Sciences announces the peer-reviewed publication of its open-label study in patients with non-active secondary progressive multiple sclerosis in Neurology Neuroimmunology & Neuroinflammation, a prestigious journal of the American Academy of Neurology.The publication, titled "Nasal Foralumab for the Treatment of Progression Independent of Relapses in Patients with Non-active Secondary Progressive Multiple Sclerosis," details the comprehensive positive results previously announced by the Company on May 6, 2025. This marks the first study to integrate TSPO-PET imaging, proteomics, and clinical assessments in na-SPMS, highlighting nasal foralumab's novel mechanism in addressing progression independent of relapse activity-a critical unmet need in multiple sclerosis treatment. Key Study Highlights: Ten patients with na-SPMS, progressing despite prior B-cell therapies, received nasal foralumab for at least six months. No serious or severe treatment-related adverse events occurred. All patients showed stabilization of Expanded Disability Status Scale scores; three of four treated for 12 months demonstrated improvement. Fatigue improved in six out of ten patients, as measured by the Modified Fatigue Impact Scale-a vital quality-of-life measure for MS patients. No new T2 lesions appeared on MRI. TSPO-PET imaging revealed significant reductions in microglial activation at three and six months. Single-cell RNA sequencing demonstrated sustained increases in regulatory T cells and TGFbeta expression, supporting induction of regulatory immunity.

Tiziana Life Sciences announces the pricing of a Company best efforts registered direct offering of 6,400,000 ordinary shares at an Offering price of $1.25 per ordinary share conducted without an underwriter or placement agent to members of senior management and existing shareholders. The total gross proceeds to Tiziana from the Offering, before deducting estimated Offering expenses payable by Tiziana, are expected to be $8M. For every ordinary share subscribed, participants will receive one warrant entitling the holder to subscribe for one new ordinary share at a price of $1.50 at any time up to and including July 16, resulting in additional gross proceeds of up to approximately $9.6M. The Offering is expected to close on January 16, subject to the satisfaction of customary closing conditions. The Offering was led by Tiziana's CEO, Ivor Elrifi, who purchased 2,400,000 ordinary shares, bringing his total holding to 2,757,848 ordinary shares. Executive Chairman and Founder of Tiziana, Gabriele Cerrone purchased 1,600,000 ordinary shares in the Offering through Panetta Partners, an entity in which he has a beneficial interest, bringing his total holdings to 44,974,830 ordinary shares.