On March 7, 2016 TG Therapeutics, Inc. (NASDAQ:TGTX) reported 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 (Filing, 8-K, Manhattan Pharmaceuticals, MAR 7, 2016, View Source [SID:1234509393]).

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."

2015 Highlights

· 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

Financial Results for the Fourth Quarter and Full Year 2015

At December 31, 2015, the Company had cash, cash equivalents, investment securities, and interest receivable of $102.4 million, as compared to $78.9 million at December 31, 2014.

Our consolidated net loss for the year ended December 31, 2015, excluding non-cash items, was approximately $47.3 million, including other research and development expenses of $43.4 million, of which approximately $23.4 million related to manufacturing and CMC expenses in preparation for Phase 3 clinical trials and potential commercialization. The consolidated net loss for the year ended December 31, 2015, inclusive of non-cash items, was $63.0 million, or $1.38 per diluted share, compared to a consolidated net loss of $55.8 million for the year ended December 31, 2014. The increase in consolidated net loss during the year ended December 31, 2015 was primarily driven by increases in other research and development expenses for both TG-1101 and TGR-1202 as a result of manufacturing and clinical trial expenses related to ongoing and planned future Phase 3 registration programs as well as launch preparation activities. The increase in other research and development expenses was partially offset by expenses recorded during 2014 in conjunction with the Company’s licensing agreements for TGR-1202 and the IRAK4 inhibitors program, and a decrease in non-cash compensation expense related to equity incentive grants over the comparable period in 2014.

Our consolidated net loss for the fourth quarter ended December 31, 2015, excluding non-cash items, was approximately $14.8 million, including other research and development expenses of $13.7 million, of which approximately $7.4 million related to manufacturing and CMC expenses in preparation for Phase 3 clinical trials and potential commercialization. The consolidated net loss for the fourth quarter ended December 31, 2015, inclusive of non-cash items, was $17.6 million, or $0.37 per diluted share, compared to a consolidated net loss of $18.8 million during the comparable quarter in 2014. The decrease in consolidated net loss during the fourth quarter ended December 31, 2015 was the result of a decrease in non-cash compensation expense related to equity incentive grants over the comparable period in 2014, partially offset by a modest increase in other research and development expenses for TGR-1202 as a result of clinical trial expenses related to ongoing and planned future Phase 3 registration programs.

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