Articles from Tiziana Life Sciences Ltd.

NEW YORK, Dec. 17, 2024 (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 a significant milestone in its clinical development program for Alzheimer’s disease. The Company has successfully dosed the first patient with moderate Alzheimer's disease using intranasal foralumab at Brigham and Women’s Hospital in Boston, Massachusetts following on from their baseline PET scan.

NEW YORK, Dec. 04, 2024 (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 the expansion of its Phase 2 clinical trial evaluating intranasal foralumab for non-active secondary progressive multiple sclerosis (SPMS). The trial sites include esteemed institutions across the Northeast of the United States.

NEW YORK, Nov. 19, 2024 (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 its grant application to the ALS Association has been approved for funding. The grant is awarded as part of the Hoffman ALS Clinical Trial Awards Program and is titled “Modulation of ALS neuroinflammation by nasal anti-CD3 monoclonal Antibody”. The Association’s grant will fund a 20-patient clinical trial of two doses of Tiziana’s novel and patented therapeutic candidate, intranasal foralumab, aimed at evaluating the safety and early-stage parameters of disease improvement in Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's disease.

NEW YORK, Nov. 01, 2024 (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 its participation in the BIO-Europe 2024 conference, taking place November 4-6 in Stockholm, Sweden. As part of the conference’s partnering meetings, Tiziana will engage with industry leaders, potential collaborators, and investors to discuss recent clinical progress, including data from its combination study involving Ozempic, a GLP-1 agonist.

Includes initial funding of approximately $5 million, as well as the option for additional proceeds of approximately $5 million

NEW YORK, Oct. 30, 2024 (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 positive results demonstrating the anti-inflammatory potential of our anti-CD3 antibody (foralumab) in combination with semaglutide, a GLP-1 agonist marketed by Novo Nordisk (NYSENVO) under the brand names Ozempic and Wegovy. The data show that the combination of nasal anti-CD3 plus semaglutide improves liver homeostasis and reduces inflammation in models of diet-induced obesity (DIO), providing a potential novel approach to combat obesity-related inflammation, and liver inflammation and dysfunction.

NEW YORK, Sept. 19, 2024 (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 the National Institutes of Health (NIH), National Institute on Aging have awarded a $4 Million grant to Dr. Howard Weiner as principal investigator at Brigham and Women’s Hospital to be the key research site, to study nasal anti-CD3 for the treatment of Alzheimer’s disease (AD). This significant grant will fund a key research study over the next several years, advancing preclinical and ultimately, clinical studies of intranasal anti-CD3 as a potential treatment for this devastating neurodegenerative condition.

NEW YORK, Aug. 19, 2024 (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 the appointment of Ivor Elrifi as its Chief Executive Officer (CEO), effective immediately.

NEW YORK, Aug. 14, 2024 (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.

NEW YORK, July 24, 2024 (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 the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its intranasal formulation of foralumab, a fully human anti-CD3 monoclonal antibody, for the treatment of non-active Secondary Progressive Multiple Sclerosis (na-SPMS).

NEW YORK, June 28, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough therapies in neurodegenerative disease secondary to active neuroinflammatory processes today announced that it had received non-dilutive funding of $3.4 million and issued a corporate update video available here.  

NEW YORK, June 26, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that the U.S. Food and Drug Administration (FDA) has allowed intranasal foralumab to be used under an Expanded Access (EA) IND in its first patient with moderate Alzheimer’s disease. Expanded access IND’s provide a pathway for patients to gain access to investigational drugs, biologics, and medical devices used to diagnose, monitor, or treat patients with serious diseases or conditions for which there are no comparable or satisfactory therapy options available outside of clinical trials.

NEW YORK, June 11, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced it has received acceptance of its submission for intranasal foralumab to receive Fast Track Designation approval for the treatment of non-active, secondary-progressive multiple sclerosis (na-SPMS) to the U.S. Food and Drug Administration (FDA).

NEW YORK, June 06, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced the qualitative results for all 10 non-active Secondary Progressive Multiple Sclerosis (na-SPMS) patients enrolled in the intermediate-size patient population Expanded Access (EA) Program receiving foralumab for at least six months.

NEW YORK, June 04, 2024 (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 it has been honored with an invitation to apply for a prestigious grant from the ALS Association head by James Berry, MD, MPH and Suma Babu, MBBS, MS, the Director and Co-Director of the Neurological Clinical Research Institute (NCRI) at Mass General Hospital, a founding member of Mass General Brigham. The grant is offered as part of the Hoffman ALS Clinical Trial Awards Program, which is specifically designated to support a groundbreaking clinical trial.

NEW YORK, May 30, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that Howard L. Weiner, M.D., Chairman of Tiziana’s Scientific Advisory Board and co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women's Hospital, a founding member of Mass General Brigham healthcare system, is being honored with the prestigious “Giants of MS” award for his outstanding contributions in the area of multiple sclerosis (MS) research. The award ceremony will take place on May 30, 2024 at the Consortium of Multiple Sclerosis Centers annual meeting being held in Nashville, Tennessee.

NEW YORK, May 13, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced it has submitted an FDA request to obtain Orphan Drug Designation for intranasal foralumab for the treatment of non-active secondary progressive Multiple Sclerosis (na-SPMS). This request would make foralumab the first therapy for na-SPMS to receive Orphan Drug Designation. Our request is supported by clinical and non-clinical evidence of Foralumab’s effectiveness in na-SPMS. The prevalence estimates, in part, are supported from the Brigham & Women’s Hospital, Boston, Massachusetts, longitudinal study, the CLIMB data of which allowed the estimate of na-SPMS in the population.

NEW YORK, April 25, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced for the first time, quantitative data showing improvement in White Matter Z-scores measured from PET images taken at 3 months in nasal foralumab treated patients with non-active secondary progressive multiple sclerosis (na-SPMS). White Matter Z-scores are a statistical measure used in neuroimaging studies to assess the integrity or abnormalities in structures of the brain.

NEW YORK, April 23, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that the U.S. Food and Drug Administration (FDA) has allowed its intranasal foralumab non-active Secondary Progressive Multiple Sclerosis (na-SPMS) Expanded Access (EA) Program to expand from 10 patients to a total of 30 patients.

NEW YORK, April 22, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced additional positive clinical results from its intermediate sized Expanded Access Program (EAP) for non-active secondary progressive multiple sclerosis (na-SPMS) patients. The data demonstrate multiple improvements in foralumab-treated patients, with 70% showing an improvement in fatigue after six months of follow-up. Fatigue is a debilitating symptom for many MS patients and is measured by the Modified Fatigue Impact Scale (MFIS).

- Intranasal foralumab attenuated microglial activation in patients with non-active secondary progressive multiple sclerosis and progression independent of relapse (PIRA) -- Data presented in a platform session at the Annual Meeting of the American Academy of Neurology in Denver, Colorado -

Oral presentation of study shows intranasal foralumab attenuates microglial activation and disease progression in multiple sclerosis (MS) patients with PIRA as measured by changes in PET scans

NEW YORK, April 11, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough neuro-immunomodulation therapies, today announced an upcoming oral presentation, titled, “Treatment of PIRA with Nasal Foralumab Dampens Microglial Activation and Stabilizes Clinical Progression in Non-Active Secondary Progressive MS” that will be presented during the “Multiple Sclerosis: Therapeutics and Clinical Decision Making” session at the Annual Meeting of the American Academy of Neurology, to be held April 13-18, 2024 in Denver, Colorado.

NEW YORK, March 05, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough neuro-immunomodulation therapies, today announced that Dr. Howard Weiner will present positive data of intranasal anti-CD3 monoclonal antibody in models of Alzheimer’s and Parkinson’s disease at AD/PD, March 5-9, 2024. AD/PD is the annual International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders in Lisbon, Portugal.

NEW YORK, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough neuro-immunomodulation therapies, today announced positive findings have been seen in a total of six out of eight Intermediate Size Patient Population Expanded Access (EA) patients. These patients have shown improvements in fatigue scores measured by the Modified Fatigue Impact Scale (MFIS). PET scan findings showing a reduction in microglial activation was also seen in the six patients with MFIS score improvement at the three-month evaluation period. PET scan findings for two additional EA patients (10 total) are planned to be available in late January.

NEW YORK, Jan. 05, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies, today announced that its Chief Operating Officer and Chief Medical Officer, Matthew Davis, MD, RPh, will present at Biotech Showcase, San Francisco, January 8-10, 2024. The presentation will be primarily focused on the recent commencement of the phase 2 trial with intranasal foralumab, a fully human anti-CD3 monoclonal antibody, for the treatment of non-active secondary progressive multiple sclerosis and other neuroinflammatory and neurodegenerative diseases such as Alzheimer’s. Tiziana’s management will also be participating in one-on-one partnering meetings throughout the conference.

NEW YORK, Jan. 05, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies, today announced filing of a new patent application relating to composition and methods for combining GLP-1ra and foralumab, a fully human anti-CD3 antibody, to achieve further reductions in systemic and vascular inflammation associated with Type 2 Diabetes (T2D) and also in a separate population of patients with non T2D obesity.

NEW YORK, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough neuro-immunomodulation therapies, today announced “first patient dosed” in its Phase 2a study comparing two doses of intranasal foralumab and placebo in patients with non-active secondary-progressive multiple sclerosis (na-SPMS).   Six investigational centers have been recruited for this double-blind, placebo-controlled trial, with up to 18 patients per treatment arm. The primary endpoint of the trial will be the change in microglial activation based on PET scans. Clinical evaluations include the Expanded Disability Status Scale (EDSS), QoL assessments, and the Modified Fatigue Impact Scale (MFIS), which assess parameters that are essential to a patient’s everyday life. Novel immuno-biomarkers will be measured also and assessed for predictive relevance. Central review of PET scans and images is an integral component of this study.

NEW YORK, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announces that Matthew Davis, Chief Operating Officer and Chief Medical Officer will present at the Webull LIVE! with Corporate Connect: Virtual Biotech Investment Webinar on Wednesday, December 6th at 3:00 PM ET. The presentation will be focused on Tiziana’s recent clinical updates and our Phase 2 trial of intranasal foralumab, a fully human anti-CD3 monoclonal antibody, for the treatment of non-active secondary progressive multiple sclerosis (na-SPMS) and other neuroinflammatory and neurodegenerative diseases such as Alzheimer’s disease.

NEW YORK, Nov. 30, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that the company has successfully enrolled and dosed four new patients with non-active secondary progressive multiple sclerosis (na-SPMS) in the Brigham and Women’s Hospital, a founding member of Mass General Brigham Healthcare System Expanded Access (EA) Program. A total of ten patients are now being followed in the EA Program.

NEW YORK, Nov. 01, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that its Chief Operating Officer and Chief Medical Officer, Matthew Davis, MD, RPh, will present at BIO-Europe, Munich, Germany, November 6-8, 2023. The presentation will be primarily focused on the recent clinical updates of intranasal foralumab, a fully human anti-CD3 monoclonal antibody, for the treatment of non-active secondary progressive multiple sclerosis and other neuroinflammatory and neurodegenerative diseases such as Alzheimer’s. Tiziana’s management will also be participating in one-on-one partnering meetings throughout the conference.

NEW YORK, Oct. 18, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, is pleased to announce a significant milestone in the treatment of multiple sclerosis. The U.S. Food and Drug Administration (FDA) has allowed multiple sclerosis patients to take home and self-administer Intranasal Foralumab, a groundbreaking treatment developed by Tiziana Life Sciences. Delivery Device Training materials have been developed and refined in collaboration with the FDA, and patients will be trained in the use of the nasal device in accordance with these materials.

NEW YORK, Oct. 16, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced six-month data showing positive clinical improvements related to Modified Fatigue Impact Scale (MFIS) scores and similar important clinical measures of physical function in foralumab-treated, non-active Secondary Progressive Multiple Sclerosis (na-SPMS) patients participating in an Expanded Access (EA) Program.   This follows on from previously announced positive six-month PET scan data which was presented at ECTRIMS 2023.

NEW YORK, Oct. 13, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that a reduction in activated microglia, as seen in six-month Positron Emission Tomography (PET) scans, has now been observed in a total of five of the six patients with non-active secondary-progressive multiple sclerosis (na-SPMS) treated with intranasal foralumab in its Expanded Access Program (EAP). Activated microglia are believed to play a prominent role in the pathogenesis of neuroinflammatory and neurodegenerative diseases including multiple sclerosis, Alzheimer’s disease, and amyotrophic lateral sclerosis, or ALS.

NEW YORK, Oct. 11, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced a late breaking poster titled, “Treatment Of Six Non-Active Secondary Progressive MS With Nasal Anti-CD3 Monoclonal Antibody (Foralumab): Safety, Biomarker, And Disability Outcomes”, will be presented at the 39th Congress of the European Committee for Treatment and Research of Multiple Sclerosis (ECTRIMS) being held in Milan, Italy, October 11-13, 2023.

NEW YORK, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of delivery, today announced that it held an Investigator’s Meeting with principal investigators at Brigham and Women’s Hospital, a founding member of Mass General Brigham Healthcare System, to begin site initiation for its lead intranasal foralumab program entering Phase 2a clinical testing in non-active Secondary Progressive Multiple Sclerosis (na-SPMS) patients. In total, six to ten new clinical trial sites will be recruited.

NEW YORK, Sept. 08, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that the Company will virtually present and host one-on-one meetings at the H.C. Wainwright 25th Annual Global Investment Conference, being held September 11-13, 2023.

NEW YORK, Sept. 06, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced acceptance of a publication, “Nasal Administration of anti-CD3 monoclonal antibody (mAb) ameliorates disease in a mouse model of Alzheimer’s disease”, in the preeminent1 journal, Proceedings of the National Academy of Sciences (PNAS), that supports foralumab’s mechanism as a potential treatment for Alzheimer’s disease (AD), a difficult-to-treat neuroinflammatory disease.2   This is the second publication pertaining to intranasal administration of anti-CD3 monoclonal antibody this year to be published in PNAS.3

NEW YORK, Aug. 23, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, is pleased to announce that it has appointed William A. Clementi, Pharm.D., FCP as Chief Development Officer. Dr. Clementi will formally take up the CDO role effective September 1, 2023. In this role, Dr. Clementi will be responsible for overseeing the company's development strategies and advancing its portfolio of groundbreaking therapeutic candidates.

NEW YORK, Aug. 23, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced an oral presentation of “Nasal anti-CD3 mAb induces Tregs that dampen microglial activation and treat neuroinflammatory diseases including MS, AD and ALS” at the 16th International Society of Neuroimmunology (ISNI) Congress in Quebec City, Canada, being held August 21-24, 2023. Dr. Weiner’s live presentation is scheduled for 11:42 a.m. ET on August 24, 2023.

NEW YORK, Aug. 17, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that Dr. Howard L. Weiner, a thought leader in the field of neurology and immunology, was featured in an exclusive live interview on Bloomberg to discuss the Company’s latest announcement on its advancement of the novel foralumab program in Alzheimer's disease following recent U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) clearance. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development.

NEW YORK, Aug. 15, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for intranasal foralumab to be studied in Alzheimer's disease. Foralumab could be a potentially groundbreaking treatment for Alzheimer’s disease, given it targets the disease’s underlying pathology by addressing the resulting neuroinflammation caused by the accumulation of toxic proteins in the brain.

NEW YORK, July 21, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences (Nasdaq: TLSA) ("Tiziana" or the "Company"), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today disclosed the receipt of a notice (the “Notice”) on July 19, 2023 from the Nasdaq Stock Market LLC (“Nasdaq”) that the Company is not currently in compliance with the $1.00 Minimum Bid Price Requirement for continued listing of the Company’s common shares on the Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5450(a)(1) (the “Minimum Bid Price Requirement”). The Notice indicated that, consistent with Nasdaq Listing Rule 5810(c)(3)(A), the Company has 180 days, or until January 16, 2024 (the “Compliance Deadline”), to regain compliance with the Minimum Bid Price Requirement by having the closing bid price of the Company’s ordinary share’s meet or exceed $1.00 per ordinary share for at least ten consecutive business days.

NEW YORK, June 13, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, is pleased to announce the appointment of Matthew Davis, MD, RPh as its new Chief Operating Officer (COO). Dr. Davis, who also serves as the Chief Medical Officer (CMO), will now take on this additional role to further drive the company's growth and strategic initiatives and will report to Gabriele Cerrone, Executive Chairman, Founder, and interim Chief Executive Officer of Tiziana.

NEW YORK, June 05, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced a reduction in microglial activation as seen in 3-month Positron Emission Tomography (PET) scans that has now been seen in a total of 5 of the 6 patients with non-active secondary-progressive multiple sclerosis (na-SPMS) treated with intranasal foralumab in its Expanded Access program. Activated microglia are believed to play a prominent role in the pathogenesis of neuroinflammatory diseases including multiple sclerosis, Alzheimer’s disease and amyotrophic lateral sclerosis (ALS).   

Webinar to take place on Monday, June 5, 2023 at 12:30 PM ET

NEW YORK, May 23, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that they are now participating on the new Webull Corporate Communication services platform. The Tiziana portal on the Webull platform will help provide the Company with a direct line of communication with its shareholders while providing Tiziana's followers with instant notifications regarding corporate content like company news, earnings reports, investor presentations, and more.

NEW YORK, May 17, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that its Chief Medical Officer is presenting at the Hanson Wade Novel Nasal Formulation and Delivery Summit on May 17 in San Diego.

NEW YORK, April 27, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced broad-based findings on the utility of nasal anti-CD3 mAb in the treatment of intracerebral hemorrhage (ICH). The data using a mouse model of collagenase-induced ICH was presented at the Annual American Academy of Neurology conference. The full presentation can be viewed at https://www.aan.com/MSA/Public/Events/AbstractDetails/52974 until May 14, 2023.

NEW YORK, April 26, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced financial results for the twelve months ended December 31, 2022, and provided a corporate update on its lead programs in development.

NEW YORK, April 24, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announces 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.

NEW YORK, April 20, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced its plan to submit an IND for intranasal foralumab in patients with mild to moderate Alzheimer’s Disease in Q2 2023.

NEW YORK, April 18, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that it is initiating a program to develop intranasal foralumab for the treatment or prevention of Type 1 Diabetes.

NEW YORK, April 13, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced it plans to investigate intranasal foralumab for the treatment of Long COVID. The work is supported by foralumab’s well-established role in de-activating microglia cells, a key component in the pathogenesis of this disease.

NEW YORK, April 10, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that poster presentations on intranasal foralumab are being presented at the “Preserving the Brain” scientific conference and exhibit held at the Fondazione Prada in Rong Zhai in Shanghai.

NEW YORK, April 04, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that Dr. Saef Izzy will present pre-clinical data on the effects of intranasal anti-CD3 monoclonal antibody in an animal model of intracerebral hemorrhage (hemorrhagic stroke) on April 23, 2023, at 2:48 PM at Neurocritical Care Scientific Platform Session at the prestigious Annual American Academy of Neurology (AAN) conference in Boston, MA.

NEW YORK, April 04, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced pre-clinical data on the effects of intranasal anti-CD3 monoclonal antibody in a model of intracerebral hemorrhage (hemorrhagic stroke) demonstrating a behavioral outcome improvement at one month.

NEW YORK, March 31, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that Dr. Howard Weiner will present positive data from a study of intranasal anti-CD3 monoclonal antibody in an animal model of Alzheimer’s disease on April 1, 2023 at the AD/PD 2023 International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders in Gothenburg, Sweden.

FDA Provides Positive Feedback on Intranasal Foralumab Program in Patients with Non-Active SPMS

NEW YORK, March 22, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company enabling breakthrough immunotherapies via novel routes of drug delivery, today announces that it has been notified that Gabriele Cerrone, its Chairman and Acting Chief Executive Officer, purchased 8,000 common shares at $0.89 per share, bringing his total holding to 38,701,237 common shares.

NEW YORK, March 21, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company enabling breakthrough immunotherapies via novel routes of drug delivery, today announces that it has been notified that Gabriele Cerrone, its Chairman and Acting Chief Executive Officer, purchased 7,500 common shares at $0.79 per share, bringing his total holding to 38,693,237 common shares.

NEW YORK, March 20, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company enabling breakthrough immunotherapies via novel routes of drug delivery, today announces that it has been notified that Gabriele Cerrone, its Chairman and Acting Chief Executive Officer, purchased 45,000 common shares at $0.66 per share, bringing his total holding to 38,685,737 common shares.

NEW YORK, March 17, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announces that it has been notified that Gabriele Cerrone, its Chairman and Acting Chief Executive Officer, purchased 25,000 common shares at $0.58 per share, bringing his total holding to 38,640,737 common shares.

Article entitled "New T Cell Antibody Treatment Improves Outcomes For Covid Patients" reviews the company's first in class foralumab, a unique Intranasal monoclonal antibody designed to treat multiple sclerosis and a range of other neurodegenerative diseases

NEW YORK, March 08, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced a publication in the preeminent1 journal, Proceedings of the National Academy of Sciences (PNAS), that illustrates the immunological basis of the mechanism of action (MoA) for intranasal foralumab. A copy of the article can be found at pnas.org.2

NEW YORK, Jan. 04, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced the Investigational New Drug (IND) application filing for milciclib in combination with gemcitabine for non-small cell lung cancer (NSCLC).

NEW YORK, Jan. 03, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that the second patient (“EA2”) with non-active secondary progressive multiple sclerosis (SPMS) receiving intranasal foralumab has shown additional clinical improvements since their last reported improvement in September 2022. The improvements were measured by the Expanded Disability Status Scale (EDSS), a U.S. Food and Drug Administration (FDA) - recognized standard clinical outcome assessment that is a measure of neural network functioning, rating different measures from 1 to 10 (disability increasing with higher scores).

LONDON, Dec. 29, 2022 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd (“Tiziana”, NASDAQ: TLSA), a biotechnology company enabling breakthrough CNS immunomodulation approaches to enhance the functionality of Treg-based therapies, today announced its interim results for the six months ended 30 June 2022.

Advancing pipeline of next generation therapeutics and diagnostics for oncology and immune diseases of high unmet need

New York, Dec. 16, 2022 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company enabling breakthrough CNS immunomodulation approaches to enhance the functionality of Treg-based therapies, announced today that the Company plans to present at the Biotech Showcase and host institutional investor and partnering meetings at this event, as well as at the LifeSci Corporate Access Event. Both in-person events are taking place January 9-10, 2023 in San Francisco, California.

NEW YORK, Dec. 15, 2022 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announces completion of the in-life portion of a 13-week, Good Laboratory Practice (GLP) foralumab intranasal pre-clinical study in transgenic HuGEMM CD3 mouse models. The study showed that intranasal foralumab, administered to the transgenic mice at doses up to 50 µg/rodent, was clinically well tolerated.

NEW YORK, Dec. 14, 2022 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company enabling breakthrough CNS immunomodulation approaches to enhance the functionality of Treg-based therapies, announced that it has received a notification letter from Nasdaq Stock Market LLC that the Company has been granted an additional 180-day compliance period, with a new deadline of June 12, 2023, to regain compliance with Nasdaq's minimum bid price rule.

NEW YORK, Dec. 06, 2022 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company enabling breakthrough immunotherapies via novel routes of drug delivery, today announced that the 2022 Annual General Meeting of the Company will be held on December 29, 2022. The record date for voting at the Annual General Meeting is set as November 30, 2022. The notice, agenda and associated material have been despatched to shareholders via mail and the notice, agenda and related financial statements in the form of the relevant Form 20-F filing are available on the Company's website at https://ir.tizianalifesciences.com/shareholder-services/annual-general-meeting and https://ir.tizianalifesciences.com/financial-information/annual-reports respectively.

NEW YORK, Nov. 23, 2022 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company enabling breakthrough CNS immunomodulation approaches to enhance the functionality of Treg-based therapies, announces publication of a scientific article in the peer-reviewed journal Frontiers in Immunology entitled “Nasal administration of anti-CD3 monoclonal antibody modulates effector CD8+ T cell function and induces a regulatory response in T cells in human subjects”(1) . The study was completed by researchers at the Brigham and Womens Hospital (BWH) and Harvard Medical School. The goal of the study was to assess safety and the immune effects of an entirely human, previously uncharacterized nasal anti-CD3 mAb (foralumab) in humans and its in vitro stimulatory properties. The findings support Tiziana’s intranasal foralumab platform as a new modality for the treatment of autoimmune and CNS diseases.

-Company to host conference call via webcast at 10 am ET-