Please wait while we load the requested 10-K report or click the link below:
TG Therapeutics, Inc. Announces Fourth Quarter and Year-End 2014 Financial Results and Business Update
Investor Conference Call to be held Thursday, March 12, 2015 at 8:30am ET
New York, NY, (March 11, 2015) – TG Therapeutics, Inc. (NASDAQ:TGTX) today announced its financial results for the fourth quarter and year ended December 31, 2014 and provided recent company developments along with a business outlook for 2015.
"2014 was an exciting and productive year for TG Therapeutics as we continued to aggressively move forward with the development of our lead drug candidates, TG-1101 and TGR-1202. We ended the year on a high note presenting a significant amount of data at the American Society of Hematology meeting. In addition to very encouraging data on the combination of TG-1101 and TGR-1202, we also presented data demonstrating high response rates for the combination of TG-1101 and ibrutinib, data that we believe supports our now on-going Phase 3 trial of that combination being conducted under a Special Protocol Assessment,” stated Michael S. Weiss, the Company's Executive Chairman and Interim Chief Executive Officer. “With TG-1101 and TGR-1202, we believe we have two drug candidates each with safety and efficacy profiles that are differentiated and uniquely suited for combination therapy, both with other novel agents, but most importantly, together in our proprietary ‘1303’ combination regimen. For 2015, we plan to focus on recruitment into our GENUINE Phase 3 study, as well as our planned first Phase 3 clinical trial of the combination of TG-1101 and TGR-1202, with a longer term vision toward additional combination trials with the goal of continuing to push toward better patient outcomes.”
Recent Developments & Highlights
|·||Commenced the GENUINE Phase 3 Clinical Trial of TG-1101 in combination with ibrutinib|
|·||Presented updated data from the Phase 2 trial of TG-1101 in combination with ibrutinib at the 56th American Society of Hematology (ASH) Annual Meeting in December, highlights from the presentation included:|
|o||95% (19/20) Overall Response Rate (ORR) in Patients with High-Risk CLL, the patient population to be studied in GENUINE Phase 3 Clinical trial|
|o||Combination of TG-1101 + ibrutinib was well tolerated with limited Grade 3/4 events|
|·||Presented updated data from the Phase 1 dose escalation trial of TGR-1202 at ASH in December, highlights from the presentation included:|
|o||93% of evaluable CLL patients (13/14) treated at therapeutic dose levels achieved a nodal PR, with 50% (7/14) achieving an objective response per iwCLL (Hallek 2008) criteria|
|o||No drug related hepatic toxicity or colitis observed to date with a median time on study of approximately 6 months and some patients on study for over 1.5 years|
|·||Presented preliminary data from Phase 1/2 dose escalation study of TG-1101 in combination with TGR-1202 at ASH in December, highlights from the presentation included:|
|o||100% of evaluable CLL/SLL patients (9/9) had nodal reductions, with 6 of 9 patients achieving an objective response per iwCLL (Hallek 2008) criteria and the remaining patients on study awaiting further assessment|
The following information was filed by Tg Therapeutics, Inc. (TGTX) on Wednesday, March 11, 2015 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
View differences made from one year to another to evaluate Tg Therapeutics, Inc.'s financial trajectory
Compare this 10-K Annual Report to its predecessor by reading our highlights to see what text and tables were
removed , and by Tg Therapeutics, Inc..