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Tiziana Life Sciences Ltd. (NASDAQ: TLSA) is a progressive clinical-stage biotechnology company committed to developing transformative therapies targeting neurodegenerative and lung diseases. The company leverages innovative drug-delivery technologies to create novel treatments aimed at improving patient outcomes.
Key to Tiziana's portfolio are two prominent compounds: Milciclib and Foralumab. Milciclib, an inhibitor of cyclin-dependent kinases, is in Phase II clinical trials for thymic carcinoma, aiming to provide new hope for patients who have exhausted chemotherapy options. Foralumab, noted for being the only fully human-engineered anti-CD3 monoclonal antibody, is in various stages of clinical development for multiple sclerosis, autoimmune, and inflammatory diseases.
In a significant advancement, Tiziana recently reported positive clinical outcomes from its Expanded Access Program (EAP) for non-active secondary progressive multiple sclerosis (na-SPMS). Intranasal administration of Foralumab led to remarkable improvement in fatigue symptoms in 70% of patients over six months, as measured by the Modified Fatigue Impact Scale (MFIS). These results signify a groundbreaking step in addressing an unmet need in MS treatment.
The company's commitment to innovation is backed by strategic partnerships with prestigious institutions like Harvard Medical School and Brigham and Women's Hospital. Tiziana’s leadership team brings extensive experience in drug development and commercialization, ensuring a firm trajectory toward regulatory approvals and market entry.
Moreover, Tiziana’s pipeline includes potential therapies for conditions like ALS, Alzheimer's, and Crohn's Disease, underscoring its dedication to tackling a broad spectrum of debilitating conditions. The company’s forward-looking approach aims to revolutionize treatment paradigms through enhanced drug delivery systems that promise increased efficacy and reduced side effects.
With a robust clinical pipeline, strategic collaborations, and innovative technologies, Tiziana Life Sciences Ltd. remains at the forefront of biopharmaceutical research, poised to make significant strides in the field of immunomodulation therapies.
Tiziana Life Sciences (NASDAQ: TLSA) has received a grant from the ALS Association through the Hoffman ALS Clinical Trial Awards Program to fund a 20-patient clinical trial of intranasal foralumab, their lead development candidate. The trial will evaluate safety and early-stage disease improvement parameters in ALS patients. Foralumab, a fully human anti-CD3 monoclonal antibody, has shown promise in treating Multiple Sclerosis, with positive results in 10 patients under an Expanded Access Program. The FDA has approved enrollment of 20 additional patients in this program.
Tiziana Life Sciences (Nasdaq: TLSA) announced its participation in BIO-Europe 2024, scheduled for November 4-6 in Stockholm, Sweden. The company will showcase its recent clinical advancements, particularly focusing on its combination study data involving Ozempic, a GLP-1 agonist, and its lead candidate, intranasal foralumab, a fully human anti-CD3 monoclonal antibody.
CEO Ivor Elrifi highlighted the conference as an opportunity to present their latest clinical findings and engage with potential partners. The company aims to leverage this platform to discuss strategic partnerships and showcase their therapeutic pipeline development, following a successful fundraising round that supports their ongoing Phase 2 studies.
Tiziana Life Sciences announced a registered direct offering of 5,263,158 common shares at $0.95 per share, raising approximately $5 million in gross proceeds. The company also issued an option for investors to acquire an additional 5,263,158 shares at the same price within 75 days, potentially raising another $5 million. The proceeds will fund Phase 2a clinical trials for intranasal foralumab in multiple sclerosis patients, accelerate Alzheimer's disease research, develop foralumab for other indications, and support working capital needs. The offering is expected to close around November 1, 2024.
Tiziana Life Sciences (TLSA) announced positive results from a study combining nasal anti-CD3 (foralumab) with semaglutide (Ozempic). The research, conducted at Brigham and Women's Hospital, demonstrated that the combination improves liver homeostasis and reduces inflammation in diet-induced obesity models. Key findings show synergistic effects in promoting liver health, with the combination therapy resulting in significant reductions in pro-inflammatory cytokines and improvements in liver markers associated with metabolic regulation. The study suggests this novel approach could effectively combat obesity-related inflammation and liver dysfunction.
Tiziana Life Sciences (NASDAQ: TLSA) has announced a $4 million grant from the National Institutes of Health to study intranasal anti-CD3 for Alzheimer's disease treatment. The grant, awarded to Dr. Howard Weiner at Brigham and Women's Hospital, will fund preclinical and clinical studies over several years. Tiziana's proprietary anti-CD3 formulation, administered intranasally, aims to modulate immune system activity and reduce neuroinflammation in Alzheimer's patients. This funding supports Tiziana's broader strategy to explore anti-CD3 in various autoimmune and inflammatory diseases. The company plans to initiate first-in-human clinical trials for Alzheimer's Disease in the coming months, marking a significant step towards potential regulatory approval and commercialization.
Tiziana Life Sciences (Nasdaq: TLSA) has appointed Ivor Elrifi as its new Chief Executive Officer, effective immediately. Elrifi, formerly the global head of the Patent Group at Cooley, brings extensive experience in intellectual property strategies and business development in the biotech and pharma sectors. Tiziana, focused on developing immunomodulation therapies, aims to accelerate its clinical trials for intranasal foralumab in treating non-active Secondary Progressive Multiple Sclerosis, Alzheimer's Disease, and ALS under Elrifi's leadership.
Gabriele Cerrone, Founder and Executive Chairman, expressed confidence in Elrifi's ability to create substantial value for the company. Elrifi's background includes guiding clients in strategic transactions and M&A involving major pharmaceutical companies. He succeeds Cerrone, who will continue as Executive Chairman, focusing on advancing Tiziana's scientific agenda.
Tiziana Life Sciences (TLSA) has regained compliance with Nasdaq's minimum bid price rule, ensuring its continued listing on the Nasdaq Capital Market. The company, which develops immunomodulation therapies, had been notified of non-compliance on July 19, 2023, when its stock failed to maintain a closing bid price of $1.00 or more for 30 consecutive business days. Tiziana successfully met the requirement by maintaining a minimum closing bid price of $1.00 or more for at least ten consecutive trading days, achieving this on August 9, 2024. As a result, the previously scheduled hearing before the Hearings Panel has been cancelled, and Tiziana's securities will continue to be listed and traded on Nasdaq.
Tiziana Life Sciences (NASDAQ: TLSA) has received FDA Fast Track designation for its intranasal foralumab, a fully human anti-CD3 monoclonal antibody, to treat non-active Secondary Progressive Multiple Sclerosis (na-SPMS). This designation expedites the review process and increases FDA interaction. Intranasal foralumab aims to modulate the immune system and reduce neuroinflammation in neurodegenerative diseases.
The company is currently conducting a Phase 2a trial for na-SPMS and has an Expanded Access Program showing promising results. However, Tiziana faces a potential Nasdaq delisting due to not maintaining a minimum bid price of $1.00. The company plans to appeal this decision and present its compliance plan to the Nasdaq Hearings Panel.
Tiziana Life Sciences (Nasdaq: TLSA) has secured $3.4 million in non-dilutive funding. This funding will support their ongoing Phase 2 trial for intranasal foralumab in treating non-active secondary progressive multiple sclerosis (na-SPMS) and advancements in Alzheimer's Disease research. Chairman and acting CEO, Gabriele Cerrone, emphasized the importance of this funding in propelling their research and expressed their intention to seek further non-dilutive funding.
Tiziana Life Sciences (Nasdaq: TLSA) announced that the FDA has granted approval for the use of intranasal foralumab in treating a patient with moderate Alzheimer's disease under an Expanded Access IND. This pathway allows patients with serious conditions, lacking other therapy options, to access investigational drugs. Dr. Howard L. Weiner, Principal Investigator and Chairman of Tiziana’s Scientific Advisory Board, expressed optimism about the potential of nasal foralumab to slow cognitive decline, citing its effectiveness in reducing microglial inflammation in progressive MS patients. The company plans to closely monitor treatment responses while preparing for a Phase 2 study targeting early symptomatic Alzheimer’s disease. Gabriele Cerrone, Chairman and acting CEO, emphasized the groundbreaking potential of foralumab in addressing neuroinflammation caused by toxic protein accumulation in the brain.
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