NEW YORK - Tiziana Life Sciences Ltd. (NASDAQ:TLSA), a biotechnology firm, announced today that it has received $3.4 million in non-dilutive funding to advance its Phase 2 clinical trial of intranasal foralumab for the treatment of non-active secondary progressive multiple sclerosis (na-SPMS). The funding is expected to support the ongoing research, as well as the company's work on Alzheimer's Disease.
Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in development and works by binding to the T cell receptor to modulate T cell function, which may reduce inflammation and suppress effector features in various immune cell subsets. This mechanism has shown promise in patients with COVID-19, multiple sclerosis, and healthy subjects.
The Phase 2 trial for intranasal foralumab (NCT06292923) began patient screening in November 2023. Tiziana's nasal delivery approach aims to improve efficacy and safety compared to traditional intravenous administration. The company believes this method could represent a new treatment avenue for neuroinflammatory and neurodegenerative diseases.
Tiziana Life Sciences focuses on developing therapies using drug delivery technologies that enable alternative routes of immunotherapy. Its lead candidate, intranasal foralumab, has so far demonstrated a favorable safety profile and clinical response in studies. The company's patented technology for alternative immunotherapy routes is expected to have broad pipeline applications.
The statement made by Gabriele Cerrone, Chairman, acting CEO, and founder of Tiziana Life Sciences, indicated the company's pursuit of additional non-dilutive funding in the near term to further support its clinical programs.
This update is based on a press release statement from Tiziana Life Sciences Ltd. The company has not provided further details on the source of the non-dilutive funding.
In other recent news, Tiziana Life Sciences has been actively involved in several significant developments. The company has been invited to apply for a grant from the ALS Association, which could support a clinical trial for its lead development candidate, intranasal foralumab. Concurrently, Tiziana has filed for FDA Orphan Drug Designation for foralumab, which if granted, could provide up to seven years of marketing exclusivity.
The company has also reported that their intranasal foralumab therapy has reduced brain inflammation in non-active secondary progressive Multiple Sclerosis (na-SPMS) patients. Additionally, the FDA has approved the expansion of Tiziana's Expanded Access program for intranasal foralumab, now including 30 patients.
Tiziana's Expanded Access Program reported that 70% of the participants experienced an improvement in fatigue, a significant symptom of MS. These recent developments highlight the company's commitment to advancing its research and potentially providing new treatments for patients with limited options.
InvestingPro Insights
In light of Tiziana Life Sciences Ltd.'s recent announcement regarding the advancement of its clinical trials, investors may be closely monitoring the company's financial health and market performance. According to real-time data from InvestingPro, Tiziana Life Sciences has a market capitalization of $89.33 million, reflecting its current valuation in the market.
With a negative price-to-earnings (P/E) ratio of -5.12 for the last twelve months as of Q4 2023, the company's earnings have not kept pace with its share price, which is a common scenario for many growth-focused biotech companies investing heavily in research and development.
InvestingPro Tips highlight that Tiziana Life Sciences has experienced a significant return over the last week, with a 10.0% price total return, and an even stronger return over the last three months, with a 93.83% price total return. These metrics indicate recent positive investor sentiment and potential market recognition of the company's developmental progress. Still, the company operates with a moderate level of debt and analysts are not optimistic about its profitability in the near term, as reflected in the expectation of a net income drop this year.
Despite these challenges, Tiziana's recent funding success could be an indicator of confidence in its long-term strategy and its focus on novel drug delivery technologies. For investors seeking a more comprehensive analysis, InvestingPro offers additional insights and tips. There are currently 9 more InvestingPro Tips available for Tiziana Life Sciences, which can be accessed at https://www.investing.com/pro/TLSA. Readers who find these insights valuable may consider using the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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