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NEW YORK - Tiziana Life Sciences Ltd. (NASDAQ:TLSA), a biotech firm focused on immunomodulation therapies with a market capitalization of $76.74 million, has announced the publication of a review article in Nature Reviews Neurology which discusses the potential of its drug candidate, intranasal foralumab, in treating multiple neurodegenerative diseases. According to InvestingPro data, while the company maintains a FAIR financial health score, it faces near-term challenges with its current ratio of 0.85 indicating potential liquidity constraints. The article, authored by Dr. Howard Weiner, Chairman of Tiziana’s Scientific Advisory Board, highlights the role of the immune system in diseases such as Multiple Sclerosis (MS), Alzheimer’s disease, ALS, and Parkinson's disease, and positions intranasal foralumab as a promising therapeutic option.
The review specifies that intranasal foralumab may dampen microglial activation, a key process in the pathogenesis of these neurological conditions. Dr. Weiner noted the drug's potential for treating several significant neurodegenerative diseases without apparent side effects and with ease of administration. Ivor Elrifi, CEO of Tiziana, expressed encouragement from the insights presented, emphasizing the company's commitment to addressing unmet medical needs in progressive MS and other neurological diseases.
Foralumab, described as the only fully human anti-CD3 monoclonal antibody in clinical development, has been shown to modulate T cell function and dampen inflammation, which could be beneficial for patients with neuroinflammatory and neurodegenerative diseases. Currently, a Phase 2a trial in patients with non-active secondary progressive multiple sclerosis is underway, and the FDA has recently allowed an additional 20 patients to be enrolled in an Expanded Access program after observing improvement or stability in the initial 10 patients dosed. While the clinical progress is promising, InvestingPro analysis reveals the company reported an EBITDA of -$15.79 million in the last twelve months, reflecting the substantial investment required in drug development. InvestingPro subscribers have access to 8 additional key insights about TLSA's financial position and market performance.
As a clinical-stage biopharmaceutical company, Tiziana Life Sciences is developing therapies using drug delivery technologies to enable alternative routes of immunotherapy. The company's nasal approach aims to improve efficacy, safety, and tolerability compared to intravenous delivery.
The information provided is based on a press release statement from Tiziana Life Sciences Ltd. The company cautions that forward-looking statements are subject to risks and uncertainties and actual results may differ materially from those projected. With analysts anticipating continued losses this year and the stock trading at a Price/Book multiple of 41.4, investors seeking deeper insights into TLSA's valuation and growth prospects can access comprehensive analysis through InvestingPro's advanced metrics and expert tools. The review article can be accessed through the Nature Reviews Neurology website.
In other recent news, Tiziana Life Sciences has reported its interim financial results for the first half of 2024, along with significant updates on its lead development programs. The company 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. Furthermore, the U.S. Food and Drug Administration has granted Fast Track designation to Tiziana's intranasal formulation of foralumab for the treatment of non-active Secondary Progressive Multiple Sclerosis.
Tiziana Life Sciences has also expanded its Phase 2 trial for MS therapy. The company's intranasal foralumab is currently under investigation in a randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial. The FDA has approved the inclusion of an additional 20 patients in this program.
Ivor Elrifi has been appointed as the new CEO of Tiziana, leading the ongoing clinical trials for intranasal foralumab. The company secured $3.4 million in non-dilutive funding to advance its Phase 2 clinical trial of intranasal foralumab for na-SPMS. 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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