Corporate Strategy

• Advance to a Phase 2 clinical development trial of orally-administered Foralumab for the treatment of Crohn’s disease by using a novel and proprietary oral formulation and intend to report interim data in 3Q/4Q 2021.
• Progressing clinical development to Phase 2 intranasal administration of Foralumab (for neurodegenerative disease indications such as Pro-MS).
• Expediting cGMP manufacturing of anti-IL-6 receptor (anti-IL-6R) monoclonal antibodies, and developing a handheld inhalation technology for direct delivery to the lungs to treat COVID-19 infections.
• Progress the clinical development and obtain regulatory approval for our lead oncology product candidate, Milciclib, as a monotherapy or in combination therapy with tyrosine kinase inhibitor in HCC.
• Tiziana intends to evaluate the safety and clinical activity of combination treatment of Milciclib with Regorafenib in liver transplant patients with recurrent HCC.
• Seek orphan drugs fast track or breakthrough designation for our product candidates where warranted.