OREANDA-NEWS. TG Therapeutics, Inc. (NASDAQ:TGTX) today announced its financial results for the second quarter ended June 30, 2016 and recent company developments.

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 and EHA 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) Annual Meeting and at the European Hematology Association (EHA) 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 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 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. 

ABOUT TG THERAPEUTICS, INC.

TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing two therapies targeting hematological malignancies and autoimmune diseases. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B?lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies, with TG-1101 recently entering clinical development for autoimmune disorders. The Company also has pre-clinical programs to develop IRAK4 inhibitors, BET inhibitors, and anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is headquartered in New York City.

TG Therapeutics, Inc.
Selected Consolidated Financial Data

Statements of Operations Information (Unaudited):

         
    Three months ended June 30,     Six months ended June 30,
    2016       2015       2016       2015  
                                 
License revenue $   38,095     $   38,095     $   76,190     $   76,190  
                                 
Costs and expenses:        
Research and development:        
  Noncash compensation   567,157       1,359,446       954,082       2,697,354  
  Other research and development      12,966,574         9,902,214          24,196,989         18,181,645  
Total research and development     13,533,731          11,261,660         25,151,071          20,878,999  
                                     
General and administrative:        
  Noncash compensation   1,081,240       4,883,540       2,393,280       8,902,660  
  Other general and administrative     1,446,567          1,004,475         2,547,438          2,008,962  
Total general and administrative     2,527,807          5,888,015         4,940,718          10,911,622  
                                 
Total costs and expenses     16,061,538          17,149,675         30,091,789          31,790,621  
                                     
Operating loss     (16,023,443 )       (17,111,580 )       (30,015,599 )       (31,714,431 )
                                 
Other (income) expense:        
  Interest income   (92,629 )     (31,551 )     (177,491 )     (53,683 )
  Interest expense   220,756       246,526       463,161       484,183  
  Change in fair value of notes payable     (252,508 )        (223,372 )        (553,545 )        (464,013 )
Total other income     (124,381 )       (8,397 )         (267,875 )           (33,513 )
                                     
Net loss $ (15,899,062 )   $   (17,103,183 )   $ (29,747,724 )   $   (31,680,918 )
         
Basic and diluted net loss per common share $    (0.33 )   $   (0.38 )   $    (0.61 )   $   (0.73 )
                                     
Weighted average shares used in computing basic and diluted net loss per common share     48,769,948         45,320,637         48,838,731        43,216,385  

           

Condensed Balance Sheet Information:

    June 30, 2016
(unaudited)		   December 31, 2015*
Cash, cash equivalents, investment securities and interest receivable   $ 75,826,932      $   102,416,894  
Total assets     94,797,540       113,473,201  
Accumulated deficit     (187,881,650 )     (158,133,926 )
Total equity     78,701,085       101,573,302