Tiziana Life Sciences unveils plans to raise US$57.25mln from US investors

Tiziana Life Sciences PLC (LON:TILS, NASDAQ:TLSA) said it plans to raise a gross US$57.25mln from US investors to fund work on three separate drug programmes. Just over 11mln new American depositary shares are being issued at US$5.20 each as part of the fundraiser, organised by ThinkEquity. The proceeds will be used “advance the clinical development” of Foralumab, its promising fully-human anti-CD3 monoclonal antibody. Cash will also be deployed to initiate trials of its other key drug Milciclib to treat a form of liver cancer called hepatocellular carcinoma (HCC) and to “expedite clinical development” of TZLS-501 for coronavirus (COVID-19). There is a lot of excitement around Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. The company will be shortly initiating phase II studies with an orally-administered drug for Crohn’s Disease and a nasally-administered derivative for progressive multiple sclerosis. Tiziana said the phase II compound has potential application in a wide range of other autoimmune and inflammatory diseases, such as type-1 diabetes, inflammatory bowel disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. On Friday, Tiziana’s shares soared after it submitted a patent application covering the potential use of nasally-administered and orally taken Foralumab for the treatment of COVID-19 either alone or in combination with other antiviral drugs. The methods of delivering the fully human anti-CD3 monoclonal antibody (mAb) could potentially modulate or stimulate the immune system to suppress cytokine storms and therefore reduce respiratory failure in coronavirus patients, the company said. Its researchers believe a combination with other anti-viral drugs could improve efficacy. Meanwhile, the ability to inhale Foralumab or take it by mouth overcomes the severe toxicities sometimes associated with the intravenous delivery of rival human anti-CD3 monoclonal antibodies.