On August 8, 2016 TG Therapeutics, Inc. (NASDAQ:TGTX) reported its financial results for the second quarter ended June 30, 2016 and recent company developments (Press release, TG Therapeutics, AUG 8, 2016, View Source [SID:1234514354]).
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Michael S. Weiss, the Company’s Executive Chairman and Interim Chief Executive Officer, stated, "The second quarter was a busy time for the Company, with data presented at both the ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) meetings on the safety and activity of TGR-1202 alone and in combination with TG-1101, which we believe continues to show that TGR-1202 is a differentiated PI3K delta inhibitor. With the recent high profile setbacks encountered for both idelalisib and duvelisib, more than ever there is a need for a PI3K delta inhibitor with a favorable therapeutic index. Outside of mantle cell lymphoma, BTK inhibitors have shown limited activity in lymphoma, making a safe and effective PI3K delta inhibitor critically important. We are committed to bringing TGR-1202 forward in CLL and across aggressive and indolent lymphomas. Accordingly, we remain highly focused on executing our ongoing Phase 3 clinical programs in CLL, our registration directed UNITY-DLBCL study, and commencing additional registration programs in iNHL in the future." Mr. Weiss continued, "During the second quarter we were also very excited to commence our first study of TG-1101 in patients with multiple sclerosis, which we intend to utilize to inform our plans for a registration study in multiple sclerosis, which we hope to commence in the first half of 2017."
Recent Developments and Highlights
Presented long-term follow-up data of TGR-1202 both alone and in combination with TG-1101 in an integrated analysis at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress demonstrating a differentiated safety profile and high response rates in CLL and NHL
Presented clinical data from the study of TGR-1202 in combination with ibrutinib in patients with advanced CLL and Mantle Cell Lymphoma at the EHA (Free EHA Whitepaper) Annual Congress demonstrating the safety and efficacy of this all oral combination
Entered into a global collaboration to develop and commercialize novel BET inhibitors for the treatment of hematological malignancies
Enrolled the first patient in the registration-directed UNITY-DLBCL Phase 2b clinical study evaluating TG-1101 and TGR-1202 as a combination compared to TGR-1202 monotherapy in patients with advanced relapsed/refractory DLBCL
Commenced the Company’s first clinical trial evaluating TG-1101 in patients with relapsing remitting multiple sclerosis
Key Remaining 2016 Milestones
Aggressively enroll into our Phase 3 and registration directed trials, including the GENUINE Phase 3, the UNITY-CLL Phase 3, and the UNITY-DLBCL Phase 2b
Continue enrollment into the Phase 2 clinical trial in Multiple Sclerosis
Present clinical data from a variety of Phase 1 and 2 clinical trials at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, in December 2016, held in San Diego, CA
Financial Results for the Second Quarter 2016
At June 30, 2016 the Company had cash, cash equivalents, investment securities, and interest receivable of $75.8 million, which we believe will be sufficient to fund our operations into the second quarter of 2018.
Our net loss for the second quarter ended June 30, 2016, excluding non-cash items, was approximately $14.3 million, which included approximately $3.4 million of manufacturing and CMC expenses for Phase 3 clinical trials and in preparation for potential commercialization. The GAAP net loss for the second quarter ended June 30, 2016, inclusive of non-cash items, was $15.9 million, or $0.33 per basic and diluted share, compared to a net loss of $17.1 million, or $0.38 per basic and diluted share during the comparable quarter in 2015. The decrease in net loss during the second quarter ended June 30, 2016 was the result of a decrease in non-cash compensation expense related to equity incentive grants over the comparable period in 2015, partially offset by an increase in clinical trial expenses (other research and development expenses) related to ongoing and planned future Phase 3 registration programs.
Our net loss for the six months ended June 30, 2016, excluding non-cash items, was approximately $26.4 million, which included approximately $7.7 million of manufacturing and CMC expenses for Phase 3 clinical trials and in preparation for commercialization. The GAAP net loss for the six months ended June 30, 2016, inclusive of non-cash items, was $29.7 million, or $0.61 per diluted share, compared to a consolidated net loss of $31.7 million, or $0.73 per basic and diluted share during the comparable period in 2015. The decrease in net loss of $1.9 million during the six months ended June 30, 2016 was the result of a decrease in non-cash compensation expense related to equity incentive grants over the comparable period in 2015, partially offset by an increase in clinical trial expenses (other research and development expenses) related to ongoing and planned future Phase 3 registration programs.