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TG Therapeutics, Inc. Announces Fourth Quarter and Year-End 2015 Financial Results and Business Update
Ended 2015 in a Strong Financial Position, With More Than $100 Million in Cash and Investments
Investor Conference Call to be held Today, Monday March 7, 2016 at 4:30pm ET
New York, NY, (March 7, 2016) – TG Therapeutics, Inc. (NASDAQ:TGTX) today announced its financial results for the fourth quarter and year ended December 31, 2015 and provided recent company developments along with a business outlook for 2016.
Michael S. Weiss, the Company's Executive Chairman and Interim Chief Executive Officer, stated, "2015 was a transformational year for our Company as we launched our first registration study, the GENUINE Phase 3 study, and also obtained an SPA for our proprietary combination of TG-1101 and TGR-1202, the ‘1303’ regimen, enabling our UNITY-CLL trial for patients with front-line and previously treated CLL. During 2016 we will be focused on executing our ongoing Phase 3 clinical programs as well as expanding our ‘1303’ regimen into registration-directed trials for both diffuse large b-cell lymphoma and indolent lymphomas.” Mr. Weiss continued, “We are also very excited to begin exploring the potential of our products in autoimmune disorders. Our IND has been cleared by the FDA Division of Neurology and we plan to launch our first Phase 2 trial in multiple sclerosis (MS) for TG-1101 in the next 30-60 days. We believe this Phase 2 study could support the commencement of a Phase 3 program next year. From a financial perspective, with more than $100 million in cash and investments we remain well positioned to execute on our business plan.”
|·||Expanded our product portfolio through a global collaboration with Checkpoint Therapeutics to develop and commercialize anti-PDL1 and anti-GITR antibody research programs from Dana Farber Cancer Institute in hematologic malignancies|
|·||Commenced enrollment into the GENUINE Phase 3 clinical trial, which is now open in over 150 sites throughout the US|
|·||Presented the first data from the triple combination study of TG-1101 + TGR-1202 + ibrutinib showing not only that the combination was well tolerated, but produced a 100% ORR in patients with high-risk CLL/SLL and a 75% ORR in indolent NHL, which includes Follicular Lymphoma and Marginal Zone Lymphoma|
|·||Obtained an SPA for the UNITY-CLL Phase 3 clinical trial of the Company's proprietary combination of TG-1101 + TGR-1202 (aka "TG-1303")|
|·||Launched a new Phase 1/2 triple therapy study of TG-1101 + TGR-1202 + the PD-1 checkpoint inhibitor pembrolizumab, the first clinical trial to evaluate the safety and efficacy of the triple combination of a PI3K delta inhibitor with an anti-CD20 mAb and an anti-PD-1 checkpoint inhibitor|
|·||Announced key data updates at the major medical conferences throughout 2015|
Key Objectives for 2016
|·||Aggressively recruit into the GENUINE Phase 3 clinical trial|
|·||Aggressively enroll into the UNITY-CLL Phase 3 clinical trial|
|·||Commence the UNITY- DLBCL Phase 2b clinical trial|
|·||Initiate a Phase 2 clinical trial in Multiple Sclerosis (MS)|
|·||Commence a registration trial for iNHL|
|·||Present updated data on the Phase 1 and 2 clinical trials at major hematology/oncology conferences during 2016|
The following information was filed by Tg Therapeutics, Inc. (TGTX) on Monday, March 7, 2016 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.
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