TG Therapeutics(US:TGTX)2019-10-04 13:56Pipeline and Regulatory Strategy - TG Therapeutics is developing medicines for B-cell diseases, including Chronic Lymphocytic Leukemia (CLL), Marginal Zone Lymphoma (MZL), and Multiple Sclerosis (MS)[4,6] - The company plans to commence a rolling submission for Umbralisib in MZL around YE2019, following discussions with the FDA and a successful trial exceeding the target 40% ORR[11,22] - A regulatory submission for Umbralisib in CLL (in combination with Ublituximab) is planned for 1H2020[11] - Ublituximab's regulatory submission for CLL (in combination with umbralisib) is also planned for 1H2020, with a submission for Multiple Sclerosis expected by YE2020[11,27] Umbralisib Highlights - Umbralisib is presented as a next-generation PI3K delta inhibitor with the potential to overcome toxicities associated with first-generation PI3K-delta inhibitors, which have shown serious side effects in 16%-48% of patients[11,12] - In MZL patients, Umbralisib demonstrated an approximate 50% ORR and was deemed well-tolerated[25] - Umbralisib monotherapy showed an 85% ORR at higher doses in early clinical data for CLL[30] Ublituximab Highlights - Ublituximab is described as a next-generation anti-CD20 monoclonal antibody with enhanced potency and shorter infusion times (1-1.5 hours) compared to other anti-CD20s (3-4 hours)[28] - In a Phase 2 trial for MS, Ublituximab demonstrated a 100% reduction in T1 Gd enhancing lesions at Week 24 and Week 48 (p=0.003)[56] Market Opportunity - The global CLL market is estimated to reach over $10 billion by 2025[35] - The global MS market is estimated to be greater than $30 billion by 2025, with Ocrelizumab having over $2 billion in 2018 annual sales[61] Financial Status - As of 9/30/2019, TG Therapeutics' stock price was $5.61[68] - As of 8/2/2019, the company had approximately 94.8 million fully diluted shares[68] - As of 6/30/19, the company had approximately $97 million in cash[68]