ð¨Trade Alert ð¨ TLSAÍ â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Trading at around $1, TLSA is a biotech company that isnât getting nearly enough attention for the monstrous upside it could see aheadâ¦. Greetings All, The biotech space holds promise for rag-to-riches stories as companies develop groundbreaking drugs to help people. Tiziana Life Sciences Ltd. is a biotech company trading on the NASDAQ that could soon catch major Wall Street attention for what could turn into a âwonder drugâ that they are developing. This is the kind of drug that could really shake things up in the trillion-dollar healthcare space! Trading under the ticker symbol TLSA, the stock holds a 12-month price forecast of $3.06, an incredible 200%+ increase from its current price. The companyâs own interim CEO and Chairman Gabriele Cerrone has recently purchased 8,000 common shares at $0.89 per share, bringing his total holding to 38,701,237 common shares. Insider ownership stands at a staggering 41% indicating that the companyâs team has complete faith in their lead candidate Foralumab turning it into the next biotech darling. Foralumab is the worldâs only fully human, anti-CD3 mAb in clinical development! It is gaining recognition across the scientific community with features in medical media that include Pharmacy Times. It was recently highlighted positively in a Forbes article that can be read [HERE.](~/AASl5QA~/RgRmBU3FP0TYaHR0cHM6Ly93d3cuZm9yYmVzLmNvbS9zaXRlcy93aWxsaWFtaGFzZWx0aW5lLzIwMjMvMDMvMTYvbmV3LXQtY2VsbC1hbnRpYm9keS10cmVhdG1lbnQtaW1wcm92ZXMtb3V0Y29tZXMtZm9yLWNvdmlkLXBhdGllbnRzLz9zaD1kMjg4NjM1NjcwZjkmX2t4PV8tSFNwbzJ5OWxEV0plNWZLNngzNmJhSWZ1cXJZU2pybUl3SU5PanBPRjk3eXA1X28zN3dOb0lNek5UMGwyRFguVGE5cmhMVwNzcGNCCmQixcgiZA5EqqJSG3RyaXN0cmFtYmFsZHdpbjg3QGdtYWlsLmNvbVgEAAXhsQ~~) What else makes TLSA stand out? The company is developing transformational formulation technologies, enabling to switch from traditional routes to alternative routes of immunotherapy to facilitate local site of action. If the company succeeds in these alternative routes of immunotherapies, it has the potential to change the way immunotherapies are currently conducted! In other words, TLSA could disrupt the immunotherapies market significantlyâ¦. The companyâs clinical pipeline is aiming to help central nervous system (CNS) diseases and includes drug assets for Secondary Progressive Multiple Sclerosis, ALS. Alzheimer's, Crohn's Disease, and KRAS+ NSCLC. âWe look forward to leveraging the exciting clinical and preclinical results from our very promising formulation of intranasal foralumab that we have generated so far in CNS-based autoimmune diseases to guide our pipeline investment. We aim to become a leading company pioneering intranasal therapies for CNS-based diseases.â - Gabriele Cerrone, executive chairman and interim CEO of Tiziana. Proactive research analyst Robin Davison recently published a 2023 Clinical Outlook for TLSA and remarked that it is ["moving forward quite nicely."](~/AASl5QA~/RgRmBU3FP0TDaHR0cHM6Ly9uZXdzZGlyZWN0LmNvbS9uZXdzL3Byb2FjdGl2ZS1yZXNlYXJjaC1hbmFseXN0LXNheXMtdGl6aWFuYS1saWZlLXNjaWVuY2VzLW1vdmluZy1mb3J3YXJkLXF1aXRlLW5pY2VseS01NDY3OTIxNzY_X2t4PV8tSFNwbzJ5OWxEV0plNWZLNngzNmJhSWZ1cXJZU2pybUl3SU5PanBPRjk3eXA1X28zN3dOb0lNek5UMGwyRFguVGE5cmhMVwNzcGNCCmQixcgiZA5EqqJSG3RyaXN0cmFtYmFsZHdpbjg3QGdtYWlsLmNvbVgEAAXhsQ~~) AND⦠the company has plenty of cash on hand to continue its clinical studies and to move closer to getting its drug candidates commercialized and into markets. TLSA ended the period with [$26.5m cash](~/AASl5QA~/RgRmBU3FP0SbaHR0cHM6Ly9maW5hbmNlLnlhaG9vLmNvbS9uZXdzL3RpemlhbmEtbGlmZS1zY2llbmNlcy1sdGQtdGl6aWFuYS0yMjAwMDAzMjEuaHRtbD9fa3g9Xy1IU3BvMnk5bERXSmU1Zks2eDM2YmFJZnVxcllTanJtSXdJTk9qcE9GOTd5cDVfbzM3d05vSU16TlQwbDJEWC5UYTlyaExXA3NwY0IKZCLFyCJkDkSqolIbdHJpc3RyYW1iYWxkd2luODdAZ21haWwuY29tWAQABeGx) as at 30 June 2022. There could be phenomenal growth potential here as Wall Street continues to learn about TLSAâs lead immunotherapeutic candidate Foralumab! Company Overview Tizianaâs innovative nasal, oral and inhalation approaches in development have the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Its technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications. The companyâs mission is to bring breakthrough therapies to patients with the aim of treating Secondary Progressive Multiple Sclerosis, ALS, Alzheimer's, and other CNS indications. Crohn's Disease, lung diseases and optimizing health outcomes. Clinical Candidates TLSAâs major clinical assets are supported by extensive worldwide issued patents and pending patent applications covering composition of matter, formulation technologies, manufacturing processes and disease indications. - Foralumab - Foralumab is a fully human anti-CD3 monoclonal antibody (mAb) for treatment of Crohnâ s Disease and neurodegenerative indications. - Anti IL-6 Receptor mAb (IL-6R:TZLS-501) - The company is developing a fully human monoclonal antibody (mAb) targeting the receptor for IL-6 as a potential treatment for lung diseases. - Milciclib - Milciclib is the Companyâs clinical candidate for the treatment in cancer indications. The company is exploring the combination of milciclib and gemcitibine in NSCLC patients with pan KRAS+ mutations. Lead Drug Candidate - Foralumab The companyâs lead candidate, intranasal foralumab, is the only fully human anti-CD3 mAb, and has demonstrated a favorable safety profile and clinical response in patients in studies to date. This unique intranasal monoclonal antibody is currently in clinical development to treat multiple sclerosis (MS) and a range of other neurodegenerative diseases. TLSA isnât in R&D⦠the company is already in the clinical stage and has completed two pivotal Phase 1 clinical trials with foralumab: - One for progressive MS indication with nasal administration - One for Crohnâs disease indication, with enteric-coated capsules administered orally Crohnâs disease affects between 400,000 and 600,000 people in North America. Current estimates for Northern Europe have ranged from 27â48 people per 100,000. Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease affecting approximately 400,000 people in the United States and 2.1 million people worldwide. The company also completed a Phase 2 trial treating mild to moderate non-hospitalized COVID-19 patients in Brazil with intranasal foralumab with positive results. Currently, six secondary progressive MS patients are being treated at Brigham and Womenâs Hospital, Boston MA, with intranasal foralumab under Expanded Access INDs with signs of clinical benefit. EA1 has completed Twenty months of treatment and EA2 has completed Thirteen months. Investigators under Tizianaâs umbrella have performed additional work using the anti-CD3 foralumab in Alzheimerâs disease (AD), Amyotrophic Lateral Sclerosis (ALS) and an undisclosed rare pediatric disease where there are no other treatments showing that there may be a benefit to patients. Others have performed studies showing that anti-CD3 may mitigate the severity of diabetes, arthritis, inflammatory bowel disease, and lupus. Foralumab has demonstrated the ability to activate regulatory T cells that systemically circulate to elicit targeted immunomodulation providing therapeutic benefit to patients. Tiziana has additionally submitted a patent application on potential use of Foralumab, to improve success of chimeric antigen receptor T cells (CAR-T) therapy for cancer and other human diseases. The patent application covers inventions related to improving CAR-T expansion and/or survival. SPMS: A Top Priority Foralumab is designed to treat patients suffering from MS, reducing inflammatory responses which are brought on by the immune system In January TLSA reported that the second patient (âEA2â) 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). Before foralumab treatment, EA2âs non-active SPMS disability had progressed and EDSS worsened from 3.5 in 2018 to 6.0 in 2021 despite ocrelizumab therapy. Ocrelizumab was discontinued in 2021. At this point, EA2 required a cane to walk 100 meters. EA2 was subsequently enrolled in the intranasal foralumab Expanded Access program in January 2022. In September 2022, 8 months after starting treatment with nasal foralumab, EA2 was able to walk 100 meters WITHOUT a cane!! EDSS score improved from 6.0 to 5.5. EA2âs pyramidal score remained stable during this time. In December 2022, 11 months after starting treatment with intranasal foralumab, EA2 was able to walk 200 meters without a cane, resulting in an even greater improvement in EDSS; with EDSS falling from a score of 5.5 to 5.0. EA2âs pyramidal score continued to remain stable. âSix patients are currently enrolled and are being followed in our intranasal foralumab program. EA2âs clinical improvement justifies Tizianaâs decision to make intranasal foralumab for non-active SPMS our top priority.â - Gabriele Cerrone, Executive Chairman and interim CEO of Tiziana. SPMS represents an advanced stage of multiple sclerosis with few treatment options and creates a severe burden on patients. For there to be a 1.0 EDSS improvement in patient EA2 following treatment with intranasal foralumabâ¦. this is truly ground-breaking! In summary⦠Biotech is a red-hot industry with diligent eyes on the arena watching out for the next big thing. The potential for substantial returns makes companies in the space perpetually attractive. Identifying companies with the best chances of developing breakthrough drugs or therapies is paramount to success and TLSA looks like one of them! The company is aiming to bring to market a unique drug candidate that could significantly help millions of people. Thereâs only one reason why insiders would be loading up and thatâs because they believe their company is headed higher⦠TLSA is already in the clinical stage and has sufficient cash reserves to perform Phase 2 MS trial. The company plans to use non-dilutive funding for Alzheimerâs Disease, ALS, and T1D studies. The cogs are in motion and Tiziana Life Sciences Ltd. (NASDAQ: TLSA) could be heading toward an FDA green light in its future. Now is the time to have the company high on your radar! Copyright 2022 © SCDalerts.com is owned and operated by the owner of SCD Media LLC. Disclaimer and Privacy For more Information please contact info@smallcapsdaily.com This website provides information about the stock market and other investments. This website does not provide investment advice and should not be used as a replacement for investment advice from a qualified professional. This website is for informational purposes only. The Author of this website is not a registered investment advisor and does not offer investment advice. You, the reader, bear responsibility for your own investment decisions and should seek the advice of a qualified securities professional before making any investment. 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