Tony here tgtx report from a month ago. But
BW did a great job
TG Therapeutics is making rapid progress in its pursuit of the best combination therapies for TG-1101, and we expect 2014 to be a busy year for data release as well as initiation of pivotal combination therapy trials. Safety results from 22 patients at doses from 50mg to 1,200mg and efficacy results from 19 patients at doses up to 800mg with TGR-1202 were presented at the last ASH meeting. All four evaluable CLL patients treated with 800mg experienced significant nodal reductions, and three achieved >50% nodal response. TG intends to present updated single agent data for TGR-1202 by mid-2014. TG initiated a Phase 2 combination trial of TG-1101 and ibrutinib, an FDA approved small molecule BTK inhibitor, in mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL). TG also initiated a combination trial of TG-1101 and TGR-1202 in relapsed and/or refractory CLL and non-Hodgkin's lymphoma (NHL). Both trials should be fully enrolled in 2014, with initial results in 5-10 patients from each trial to be presented in mid-2014 and more results at major medical meetings throughout 2014. We believe that after showing early efficacy at 2-4 months (somewhere in the 80-90% response rate range) in only about 20-30 patients, a Phase 3 trial could then be initiated by YE14 comparing ibrutinib monotherapy to the combination therapy. TG has a strong cash position of $45.4 million, with cash burn expected to be $4-5 million per quarter in 2014.
Discussion
TGR-1202 single agent trial update. Safety results from 22 patients at doses from 50mg to 1,200mg QD and efficacy results from 19 patients at doses up to 800mg in the dose-escalation Phase 1 trial of TGR-1202 were presented at the last ASH meeting. All four evaluable CLL patients treated with the 800mg QD dose experienced significant nodal reductions, and three of them achieved >50% nodal partial response. No hepatotoxicity or GI SAEs were observed and GI AEs were limited. Some patients are now approaching 12 months of treatment, no MTD has yet been determined, and TG is dosing patients at 1,800mg QD to identify an optimal dose for TGR-1202. The first expansion cohort at 800mg is near completion, and shortly TG plans to launch an additional expansion cohort at 1,200mg. TG intends to present updated single agent data for TGR-1202 by mid-2014. The 800mg and 1,200mg doses of TGR-1202 achieved greater drug exposure than idelalisib, a leading PI3K delta inhibitor, and TG is working on new formulations of TGR-1202 to achieve drug exposure that is similar to that of idelalisib at lower doses of TGR-1202.
TG-1101 combination trial update. TG initiated a Phase 2 combination trial of TG-1101 and ibrutinib, an FDA approved small molecule BTK inhibitor, in mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL). TG also initiated a combination trial of TG-1101 and TGR-1202 in relapsed and/or refractory CLL and non-Hodgkin's lymphoma (NHL). Both trials should be fully enrolled in 2014, with initial results in 5-10 patients from each trial to be presented in mid-2014 and more results at major medical meetings throughout 2014. For the combination trial with ibrutinib, TG is looking to boost the early nodal response rate up to above 90% from ibrutinib's single agent rate of roughly 70%. We believe that after showing early efficacy at 2-4 months (somewhere in the 80-90% response rate range) in only about 20-30 patients, a Phase 3 trial could then be initiated by YE14 comparing ibrutinib monotherapy to the combination therapy. In our view, the two newly initiated combination trials are by far the better path forward for TG-1101, rather than the Phase 1/2 trial of TG-1101 in combination with Revlimid in patients with Rituxan relapsed /refractory B- cell malignancies or the Phase 1/2 trial of single agent TG-1101. The single agent Phase 1/2 trial completed enrollment of about 30 patients in the escalation and expansion cohorts, with updated results expected by mid-2014.
Sufficient cash to support clinical development into 2015. As of YE14, TG has $45.4 million in cash, with a cash burn expected to be $4-5 million per quarter in 2014. TG recognized 4Q13 revenue of $0.04 million and EPS of $(0.19), in line enough with consensus revenue of $0.04 million and EPS of $(0.18), neither of which matter at this point in TG’s development. The $38,000 license revenue was the 4Q13 recognition of the $2 million upfront payment by Ildong Pharmaceutical.
Valuation / Target Price
We derive our target price of $13 through a DCF analysis, using a 35% discount
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