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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) has showcased promising developments in their intranasal foralumab treatment for moderate Alzheimer's disease through a national radio interview. The treatment, a fully human anti-CD3 monoclonal antibody administered as a nasal spray, targets brain inflammation associated with Alzheimer's progression. Dr. Howard Weiner highlighted remarkable results from the first patient, Joe Walsh, at Brigham and Women's Hospital in Boston. According to Walsh's wife Karen, the treatment has led to noticeable improvements in his social engagement and overall condition. The case represents an encouraging advancement in Alzheimer's treatment, particularly in addressing brain inflammation as a key factor in disease progression.
Tiziana Life Sciences (NASDAQ: TLSA) announced that Executive Chairman and Founder Gabriele Cerrone has increased his stake in the company through the purchase of 15,000 common shares at $1.55 per share. Following this transaction, Cerrone's total holdings have reached 43,252,143 common shares, representing 37.02% of the company's issued share capital. Tiziana is developing immunomodulation therapies, with its lead candidate being intranasal foralumab, a fully human anti-CD3 monoclonal antibody.
Tiziana Life Sciences (NASDAQ: TLSA) has announced positive results from a clinical study of nasal foralumab in treating non-active secondary progressive multiple sclerosis (na-SPMS). The study involved 10 patients who were treated for a minimum of six months, with key findings including:
- No serious treatment-related adverse events reported
- Stabilization of Expanded Disability Status Scale (EDSS) scores in all patients
- Improvement in fatigue symptoms in 6 out of 10 patients
- Significant reductions in microglial activation at six months (p0.05)
- Increased regulatory T cells and TGFβ expression
The company has initiated a randomized, double-blind, placebo-controlled Phase 2 clinical trial with expected top-line data by the end of 2025. The treatment represents a novel approach for na-SPMS patients who currently have limited treatment options.
Tiziana Life Sciences (Nasdaq: TLSA) has announced the commencement of dosing at the University of Massachusetts, the fourth clinical site in its ongoing Phase 2 trial of intranasal foralumab for non-active secondary progressive multiple sclerosis (na-SPMS). UMass joins Brigham and Women's Hospital, Yale Multiple Sclerosis Center, and Johns Hopkins University in the study.
The blinded, placebo-controlled trial is expected to conclude by end-2025, followed by a six-month open-label extension phase where all participants can receive the treatment. Foralumab, the first fully human anti-CD3 monoclonal antibody administered intranasally, is designed to engage regulatory T cells and promote immune tolerance while minimizing systemic immune suppression.
The intranasal administration allows for at-home dosing, potentially improving compliance compared to intravenous treatments, particularly beneficial for patients dealing with fatigue.
Tiziana Life Sciences (Nasdaq: TLSA) has announced the commencement of dosing at Johns Hopkins University (JHU), the third clinical site in its Phase 2 trial of intranasal foralumab for non-active Secondary Progressive Multiple Sclerosis (na-SPMS). The trial, also conducted at Brigham and Women's Hospital and MS Center at Yale Medical Center, is a randomized, double-blind, placebo-controlled study.
The trial aims to evaluate the safety, tolerability, and efficacy of intranasal foralumab, a fully human anti-CD3 monoclonal antibody, in na-SPMS patients who experience progressive neurological decline without relapses. The blinded portion is expected to complete by end of 2025, followed by a six-month open-label extension period where all participants can receive the treatment.
Tiziana Life Sciences (NASDAQ: TLSA) has commenced dosing new patients at Yale MS Center as part of its multicenter Phase 2 clinical trial evaluating intranasal foralumab for non-active Secondary Progressive Multiple Sclerosis (na-SPMS). The trial is also enrolling at Johns Hopkins, U Mass Medical Center, and Brigham and Women's Hospital.
The double-blinded, placebo-controlled study aims to assess safety, tolerability, and foralumab's effect on microglial activation in na-SPMS patients. The trial combines brain PET imaging, immunology, and FDA-accepted clinical evidence measures.
Expected completion is by end of 2025, followed by a 6-month open-label extension (OLE) study to evaluate long-term safety, tolerability, and durable effectiveness. Foralumab, a fully human anti-CD3 monoclonal antibody, represents a novel approach to potentially mitigate SPMS progression.
Tiziana Life Sciences (Nasdaq: TLSA), a biotechnology company focused on developing breakthrough immunomodulation therapies, has announced its participation in the 37th Annual ROTH Conference from March 16-18, 2025, in Dana Point, California.
CEO Ivor Elrifi will lead a virtual fireside chat on Tuesday, March 18, 2025, at 12:00 pm PST (15:00 ET / 19:00 GMT). The company will also participate in one-on-one investor meetings during the conference.
The event will feature approximately 450 private and public companies from various growth sectors, offering opportunities for 1-on-1 meetings, analyst-selected fireside chats, and industry keynotes. Tiziana's lead development candidate is intranasal foralumab, a fully human, anti-CD3 monoclonal antibody.
Tiziana Life Sciences (Nasdaq: TLSA) has successfully regained compliance with Nasdaq's minimum bid price requirement for continued listing on the Nasdaq Capital Market exchange. The company, which develops immunomodulation therapies with its lead candidate intranasal foralumab (a fully human, anti-CD3 monoclonal antibody), had received a non-compliance notice on January 29, 2025, for failing to maintain a closing bid price of $1.00 or more for 30 consecutive business days under Rule 5550(a)(2).
The company met the requirement to maintain a minimum closing bid price of $1.00 or more for at least ten consecutive trading days on March 12, 2025, resolving the compliance issue. As a result, Tiziana's securities will continue to be listed and traded on The Nasdaq Stock Market.