NIH awards $4 million grant for Alzheimer’s research By Investing.com

NEW YORK – Tiziana Life Sciences Ltd. (NASDAQ:), a biotech firm focused on developing immunomodulation therapies, today announced the receipt of a $4 million grant from the National Institutes of Health (NIH) to investigate the use of intranasal foralumab, an anti-CD3 monoclonal antibody, for the treatment of Alzheimer’s disease. The grant was awarded to Dr. Howard Weiner, Principal Investigator at Brigham and Women’s Hospital, which will serve as the primary research site.

The funding will support a multi-year study aimed at advancing preclinical and clinical research of intranasal anti-CD3 as a potential therapy for Alzheimer’s, a neurodegenerative disorder affecting over 6 million people in the U.S. alone. The research will explore how anti-CD3 can modulate the immune system to reduce neuroinflammation and potentially slow the disease’s progression.

Tiziana’s proprietary formulation of anti-CD3 is designed to stimulate T regulatory cells by binding to the T cell receptor, which may deliver therapeutic effects to the central nervous system. The company plans to initiate first-in-human clinical trials for Alzheimer’s patients in the near future.

Foralumab has demonstrated the ability to modulate immune cell function, which has been observed in patients with COVID-19, multiple sclerosis, and in healthy subjects. The drug is also being evaluated in a Phase 2a trial for non-active secondary progressive multiple sclerosis.

The NIH grant is a significant step in Tiziana’s broader strategy to investigate anti-CD3’s utility in treating autoimmune and inflammatory diseases. The company’s approach to alternative routes of immunotherapy, including intranasal delivery, aims to enhance both efficacy and safety compared to traditional intravenous administration.

This announcement is based on a press release statement and contains forward-looking statements regarding the potential impact of Tiziana’s research and the expected initiation of clinical trials. The company’s progress and future plans reflect its commitment to addressing unmet medical needs in the field of neurodegenerative diseases.

In other recent news, Tiziana Life Sciences has experienced several significant developments. The company has appointed Ivor Elrifi as its new CEO, who will lead the ongoing clinical trials for its leading drug candidate, intranasal foralumab. Tiziana’s intranasal formulation of foralumab has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of non-active Secondary Progressive Multiple Sclerosis (na-SPMS), potentially accelerating its availability to patients.

Tiziana has also secured $3.4 million in non-dilutive funding to advance its Phase 2 clinical trial of intranasal foralumab for na-SPMS. The company has successfully regained compliance with the Nasdaq’s minimum bid price requirement, ensuring that Tiziana’s securities will remain listed on the Nasdaq Stock Market.

Additionally, Tiziana has been invited to apply for a grant from the ALS Association to support a clinical trial for intranasal foralumab, reflecting its ongoing efforts in developing treatments for amyotrophic lateral sclerosis (ALS). The FDA has approved the expansion of Tiziana’s Expanded Access program for intranasal foralumab, now including 30 patients.

Lastly, Tiziana reported that 80% of the participants in an Expanded Access Program showed a qualitative reduction in microglial activity after six months of treatment with intranasal foralumab. These developments underscore Tiziana’s commitment to advancing its research and providing potential new treatments for patients with limited options.

InvestingPro Insights

As Tiziana Life Sciences Ltd. (NASDAQ:TLSA) garners attention with its recent NIH grant for Alzheimer’s research, investors are closely monitoring the company’s financial health and market performance. According to InvestingPro data, Tiziana Life Sciences has a market capitalization of $108.62 million, indicating a modest size in the biotech industry. The company’s Price / Book ratio stands at a high 19.62 as of the last twelve months ending Q4 2023, suggesting a significant premium placed by investors on its book value. Despite these valuations, Tiziana has been operating at a loss, with an adjusted operating income of -$17.98 million and a return on assets of -91.52% for the same period.

InvestingPro Tips reveal a nuanced picture of Tiziana’s financial outlook. On one hand, the company has experienced a “significant return over the last week” and a “strong return over the last three months,” with price total returns of 15.26% and 48.61%, respectively. On the other hand, analysts have concerns about profitability, as Tiziana is “not profitable over the last twelve months” and “net income is expected to drop this year.” Investors should note that while the company has seen a “large price uptick over the last six months,” with a 118.37% return, it does not pay a dividend to shareholders, which may be a consideration for income-focused portfolios.

For investors seeking a deeper dive into Tiziana Life Sciences’ financials and future outlook, InvestingPro offers additional tips on the company’s performance and projections. With a total of 11 InvestingPro Tips available, interested parties can find more detailed analyses and metrics at https://www.investing.com/pro/TLSA, which could be instrumental in making informed investment decisions in the biotech sector.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.