DENVER, July 02, 2025 (GLOBE NEWSWIRE) -- Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life, announced today that it has received confirmation from The Nasdaq Stock Market that the Company has evidenced compliance with the minimum $2.5 million stockholders’ equity requirement and all other applicable criteria for continued listing on The Nasdaq Capital Market. Accordi ...

NEW YORK, June 13, 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 announces that dosing has commenced at the prestigious Weill Cornell Medicine Multiple Sclerosis Center in New York City, in its ongoing Phase 2 clinical trial evaluating intranasal foralumab in patients with n ...

Core Insights - Tiziana Life Sciences is developing intranasal foralumab, a fully human anti-CD3 monoclonal antibody, aimed at treating neuroinflammatory and neurodegenerative diseases [1][3][4] - The company is conducting a Phase 2 trial for non-active Secondary Progressive Multiple Sclerosis (na-SPMS) and plans to initiate a Phase 2 trial for early Alzheimer's Disease [1][2] Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on innovative drug delivery technologies for immunotherapy [4] - The company’s lead candidate, intranasal foralumab, is the only fully human anti-CD3 monoclonal antibody currently in clinical development, showing a favorable safety profile and clinical response [4] Clinical Development - The Phase 2 trial for intranasal foralumab in na-SPMS began patient screening in November 2023, with positive outcomes reported in an open-label program involving 10 patients [2][3] - The drug is designed to stimulate T regulatory cells through intranasal administration, promoting immune tolerance while minimizing systemic immune suppression [1][2]

Core Insights - Tiziana Life Sciences has made advancements in treating moderate Alzheimer's disease with its intranasal foralumab, a fully human anti-CD3 monoclonal antibody, which targets brain inflammation [1][2][4] Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies, particularly intranasal administration [6] - The company’s lead candidate, foralumab, is the only fully human anti-CD3 monoclonal antibody currently in clinical development, demonstrating a favorable safety profile and clinical response in previous studies [5][6] Clinical Developments - The first patient treated with intranasal foralumab, Joe Walsh, showed significant reduction in brain inflammation, indicating a promising step forward in Alzheimer's treatment [2][3] - Foralumab is also being studied in a Phase 2a trial for patients with non-active secondary progressive multiple sclerosis, with positive outcomes observed in an open-label program [4][5] Treatment Mechanism - Foralumab works by stimulating T regulatory cells through intranasal dosing, which helps mitigate inflammation in the brain, a critical factor in the progression of Alzheimer's disease [4][5]

Tivic Health Systems (TIVC) Q1 2025 Earnings Call May 15, 2025 04:30 PM ET Company Participants Jennifer Ernst - Co-Founder, CEO & DirectorLisa Wolf - Interim CFOMichael Handley - COO & President of the Biopharma Division Operator Welcome to the Trivik Health First Quarter twenty twenty five Financial Results and Operational Update Conference Call. This call has been pre recorded and the questions you have submitted in advance will be answered following the prepared remarks. This call is being webcast and t ...

NEW YORK, May 09, 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 results of a PET scan showing a marked reduction in microglia activation associated with neuroinflammation in a patient suffering from moderate Alzheimer's disease (AD) who was treated for three months ...

Core Insights - Tiziana Life Sciences announced significant results from a PET scan showing a marked reduction in microglia activation in a patient with moderate Alzheimer's disease after three months of treatment with intranasal foralumab, indicating potential efficacy in reducing neuroinflammation associated with the disease [1][5][7] Company Overview - Tiziana Life Sciences is a biotechnology company focused on developing innovative immunomodulation therapies, with intranasal foralumab as its lead candidate, which is a fully human anti-CD3 monoclonal antibody [1][10] - The company aims to provide alternative routes of immunotherapy, potentially improving efficacy and safety compared to traditional intravenous delivery methods [10] Treatment Efficacy - The PET scan results presented at the 2025 AD/PD Conference indicated a substantial decrease in TSPO signal, suggesting that foralumab may effectively reduce microglial activation, a critical factor in neuroinflammation related to Alzheimer's disease [5][7] - Foralumab has shown promise not only in Alzheimer's but also in other neurodegenerative diseases, including secondary progressive multiple sclerosis, where it has demonstrated stabilization or improvement of symptoms [6][8][10] Market Need - Alzheimer's disease currently affects over 50 million people worldwide, with projections indicating that this number could triple by 2050, highlighting the urgent need for effective treatments, particularly for moderate stages of the disease [7][10]

Core Viewpoint - Tiziana Life Sciences is advancing its Phase 2 trial of intranasal foralumab for treating non-active Secondary Progressive Multiple Sclerosis (na-SPMS), with dosing now initiated at Johns Hopkins University, marking a significant milestone in the company's clinical development efforts [1][3]. Group 1: Clinical Trial Details - The Phase 2 trial is randomized, double-blind, and placebo-controlled, focusing on the safety, tolerability, and efficacy of intranasal foralumab in na-SPMS patients, a form of multiple sclerosis characterized by progressive neurological decline without relapses [2][3]. - The trial includes multiple clinical sites, with Johns Hopkins University being the third site added, alongside Brigham and Women's Hospital and MS Center at Yale Medical Center [1][3]. - The blinded portion of the trial is expected to be completed by the end of 2025, followed by a six-month open-label extension period for all participants [3]. Group 2: Drug Candidate Information - Foralumab is a fully human anti-CD3 monoclonal antibody that stimulates T regulatory cells when administered intranasally, representing a novel approach to treating neuroinflammatory and neurodegenerative diseases [4][5]. - In an open-label intermediate-sized Expanded Access Program, 10 patients with na-SPMS have shown either improvement or stability of disease within six months [4]. - Foralumab is currently the only fully human anti-CD3 monoclonal antibody in clinical development, with its Phase 2 trial having begun patient screening in November 2023 [5]. Group 3: Company Commitment and Innovation - Tiziana Life Sciences emphasizes its commitment to innovation in treating neurodegenerative diseases, reinforced by the expansion of the trial to a major clinical site [4]. - The company believes that intranasal foralumab could represent a paradigm shift in addressing non-active Secondary Progressive MS, aiming to provide new hope for patients [4][6]. - Tiziana's innovative nasal drug delivery technology is expected to improve efficacy, safety, and tolerability compared to traditional intravenous delivery methods [6].

Nektar Therapeutics (NKTR) Q4 2024 Earnings Call March 13, 2025 01:38 AM ET Company Participants Vivian Wu - Director of Investor Relations & Corporate AffairsHoward W. Robin - CEO, President & DirectorBrian Kotzin - Interim Chief Medical OfficerJonathan Zalevsky - Senior VP & Chief Research and Development OfficerSandra Gardiner - Chief Financial OfficerJulian Harrison - Managing DirectorMayank Mamtani - Senior Managing Director Conference Call Participants Yasmeen Rahimi - Sr. Research AnalystJay Olson - ...