NEW YORK - Tiziana Life Sciences , Ltd. (NASDAQ:TLSA), a clinical-stage biotechnology company with a market capitalization of $80 million, announced today that its nasal anti-CD3 monoclonal antibody, foralumab, has shown potential in sustaining tissue homeostasis and mitigating side effects following the discontinuation of GLP-1 agonists, which are commonly used in metabolic disorder treatments. According to InvestingPro data, while the company maintains a FAIR overall financial health score, it faces near-term profitability challenges common to early-stage biotech firms. The company's research indicates that foralumab may provide a novel approach to maintaining the benefits of GLP-1 therapies without the associated adverse effects, which often lead to therapy cessation.
GLP-1 agonists, such as semaglutide, are effective in treating metabolic disorders but can cause issues like sarcopenia and bone density loss over time. Tiziana's therapy aims to counter these side effects, potentially improving long-term patient outcomes. With current operations showing negative EBITDA of $15.79 million, InvestingPro subscribers can access 8 additional key financial metrics and tips to better understand the company's development trajectory and market position. Dr. Howard Weiner, Chairman of Tiziana's Scientific Advisory Board, stated that the nasal anti-CD3 therapy not only enhances but may also sustain the positive effects of GLP-1 agonists post-discontinuation.
The therapy operates by inducing regulatory T cells to reduce tissue inflammation and promote homeostasis. This mechanism has been observed to be effective in clinical trials involving patients with COVID-19, multiple sclerosis, and healthy subjects. Tiziana's CEO, Ivor Elrifi, emphasized the importance of these findings for the treatment of metabolic disorders and age-related diseases.
Foralumab is currently in a Phase 2a trial for non-active secondary progressive multiple sclerosis (NCT06292923), and the FDA has recently approved the expansion of an Expanded Access Program to include additional patients. Trading at $0.74 per share, the stock has shown resilience with a 31% return over the past year, despite the company's development-stage status. Tiziana Life Sciences is focused on developing therapies that use drug delivery technologies to improve the efficacy, safety, and tolerability of immunotherapies.
This announcement is based on a press release statement and reflects the company's research findings and ongoing clinical developments. It is important to note that these statements are forward-looking and actual results may vary as further research and development continue.
In other recent news, Tiziana Life Sciences has made significant strides in its research and development efforts. The company reported interim financial results for the first half of 2024, highlighting the progress of its lead development programs. Tiziana was awarded a $4 million grant from the National Institutes of Health for Alzheimer's research, focusing on the potential use of intranasal foralumab as a therapy. The U.S. Food and Drug Administration granted Fast Track designation to Tiziana's intranasal formulation of foralumab for the treatment of non-active Secondary Progressive Multiple Sclerosis.
Ivor Elrifi, the new CEO of Tiziana, is leading the ongoing clinical trials for intranasal foralumab. Tiziana secured $3.4 million in non-dilutive funding to advance its Phase 2 clinical trial of intranasal foralumab for na-SPMS. The company has also expanded its Phase 2 trial for MS therapy, with the FDA approving the inclusion of an additional 20 patients.
Lastly, 80% of the participants in an Expanded Access Program showed a reduction in microglial activity after six months of treatment with intranasal foralumab. These are the recent developments in Tiziana Life Sciences' ongoing operations.
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