TLSA

Tiziana Life Sciences Regains Compliance with Nasdaq Listing Requirements

Tiziana Life Sciences regains Nasdaq compliance after meeting minimum bid price requirement for continued listing.

Quiver AI Summary

Tiziana Life Sciences, Ltd. announced that it has regained compliance with Nasdaq's minimum bid price requirement, having met the criteria by maintaining a closing bid price of $1.00 or more for at least ten consecutive trading days, culminating on March 12, 2025. This follows a previous notification from Nasdaq indicating non-compliance due to Tiziana's stock price falling below the required threshold. The company is focused on developing innovative immunomodulation therapies, particularly its lead candidate, intranasal foralumab, a fully human anti-CD3 monoclonal antibody that has shown potential in treating non-active secondary progressive multiple sclerosis. Tiziana's approach emphasizes the benefits of nasally administered therapies, which may offer improved safety and efficacy compared to traditional intravenous methods. The company's ongoing clinical trials for foralumab are showing encouraging results, and Tiziana continues to explore its patented technologies aimed at enhancing immunotherapy delivery.

Potential Positives

  • Tiziana has regained compliance with Nasdaq listing requirements, ensuring continued trading on the Nasdaq Capital Market.
  • The company's lead candidate, intranasal foralumab, shows promising results in treating patients with non-active secondary progressive multiple sclerosis, with all patients exhibiting improvement or stability of disease.
  • The FDA has allowed for the enrollment of an additional 20 patients in the Expanded Access Program for foralumab, indicating regulatory support and potential for increased clinical data.
  • Tiziana's innovative nasal delivery approach for immunomodulation therapies may enhance efficacy and safety compared to traditional intravenous methods.

Potential Negatives

  • Despite regaining compliance with Nasdaq, the company was previously non-compliant, reflecting volatility and potential instability in its stock price, which could affect investor confidence.
  • The need to regain compliance after failing to meet the minimum bid price requirement suggests challenges in maintaining adequate market performance, which could hinder future fundraising efforts.
  • The limited number of patients currently involved in the Expanded Access Program and the Phase 2a trial may raise concerns about the scalability and market potential of the company's lead therapy.

FAQ

What recent compliance update did Tiziana Life Sciences receive from Nasdaq?

Tiziana Life Sciences has regained compliance with the Nasdaq listing minimum bid price requirement after meeting the necessary price for ten consecutive trading days.

What is intranasal foralumab?

Intranasal foralumab is a fully human anti-CD3 monoclonal antibody that helps regulate T cell function to reduce inflammation, particularly in multiple sclerosis.

How many patients have been dosed with foralumab in the Expanded Access Program?

Ten patients with Non-Active Secondary Progressive Multiple Sclerosis have been dosed in the Expanded Access Program, showing improvements or stability in their condition.

What is Tiziana Life Sciences' focus in biotechnology?

Tiziana Life Sciences focuses on developing breakthrough immunomodulation therapies using innovative drug delivery methods, particularly through intranasal routes.

How does foralumab affect T cells in the body?

Foralumab binds to T cell receptors, modulating their function to suppress inflammatory responses, which can benefit patients with conditions like multiple sclerosis and COVID.

Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.


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Full Release



NEW YORK, March 14, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq:

TLSA

) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced that it has received a notification from the Nasdaq Stock Market LLC (“Nasdaq”) Listing Qualifications Department informing the Company that it has regained compliance with the Nasdaq listing minimum bid price requirement for continued listing on the Nasdaq Capital Market exchange.



Tiziana was previously notified by Nasdaq on January 29, 2025 that it was not in compliance with the minimum bid-price listing rule (under Rule 5550(a)(2)) because its common stock failed to meet the closing bid price of $1.00 or more for 30 consecutive business days. To regain compliance, the Company was required to maintain a minimum closing bid price of $1.00 or more for at least ten consecutive trading days which was met on March 12, 2025. Accordingly, the Company has regained compliance with Listing Rule 5550(a)(2), and this matter is now closed. The Company’s securities will continue to be listed and traded on The Nasdaq Stock Market.




About Foralumab



Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 10 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (

NCT06802328

) with either an improvement or stability of disease seen within 6 months in all patients. The FDA has recently allowed an additional 20 patients to be enrolled in this EA program. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (

NCT06292923

).



Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development, binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets. This effect has been observed in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. The non-active SPMS intranasal foralumab Phase 2 trial (NCT06292923) began screening patients in November of 2023. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of neuroinflammatory and neurodegenerative human diseases.

[1],[2]




About Tiziana Life Sciences



Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.



For more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit

www.tizianalifesciences.com

.



For further inquiries:




Tiziana Life Sciences Ltd



Paul Spencer, Business Development, and Investor Relations


+44 (0) 207 495 2379


email:

info@tizianalifesciences.com



[1]

https://www.pnas.org/doi/10.1073/pnas.2220272120





[2]

https://www.pnas.org/doi/10.1073/pnas.2309221120






This article was originally published on Quiver News, read the full story.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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