Company Update (NASDAQ:TGTX): TG Therapeutics Inc Announces Second Quarter 2015 Financial Results and Business Update


TG Therapeutics Inc (NASDAQ:TGTX) announced its financial results for the second quarter ended June 30, 2015 and recent company developments.

Michael S. Weiss, the Company’s Executive Chairman and Interim Chief Executive Officer, stated, “The second quarter was a busy and exciting time for the Company, as the data presentations made during the quarter continue to reinforce our belief that the safety and efficacy profiles of TG-1101 and TGR-1202, alone or in combination together in our “1303” regimen, allow for safe and efficacious multiple drug regimens, which we firmly believe is the future of patient care in the treatment of B-cell malignancies. We remain focused on commencing additional combination registration trials in the coming months, and aggressively recruiting into our ongoing GENUINE Phase 3 clinical trial.” Mr. Weiss continued, “From a financial perspective, with cash on hand of more than $125 million on a pro forma basis, we are well positioned to execute on our goals and bring the Company to substantial value creating milestones.”

Recent Developments and Highlights

  • Clinical data on the combination of TG-1101 and TGR-1202 was presented at the 51st American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago, Illinois, as well as in poster presentations at the European Hematology Association (EHA) Annual Meeting held inVienna, Austria and the International Congress on Malignant Lymphoma (ICML), held in Lugano, Switzerland
  • Single agent clinical data for TGR-1202 was presented at the ASCO Annual Meeting, as well as in oral presentations at the EHA and Lugano ICML meetings
  • Clinical data on the triple combination of TG-1101, TGR-1202, and ibrutinib was presented in an oral presentation at the ASCO Annual Meeting, and in an oral presentation at the Lugano ICML meeting
  • Updated results from a Phase 2 clinical trial of TG-1101 in combination with ibrutinib in relapsed/refractory Chronic Lymphocytic Leukemia (CLL) was presented in an oral presentation at the Lugano ICML meeting
  • Presently have over 120 sites open for the Company’s GENUINE Phase 3 Clinical Trial of TG-1101 in combination with ibrutinib in patients with High-Risk Chronic Lymphocytic Leukemia

Reaffirming 2015 Milestones

  • Continue to aggressively recruit into the GENUINE Phase 3 Clinical Trial of TG-1101 in combination with ibrutinib
  • Commence additional combination Phase 3 clinical trials, particularly for the Company’s proprietary “1303” combination of TG-1101 plus TGR-1202 in patients with Chronic Lymphocytic Leukemia (CLL) and non-Hodgkin’s Lymphoma (NHL)
  • Launch new triple therapy combination trials in addition to the currently enrolling Phase 1/2 trial of TG-1101 plus TGR-1202 plus ibrutinib
  • Continue to push forward our preclinical development programs, including the IRAK4, anti-PD-L1, and anti-GITR programs, as well as opportunistically seek to identify drug candidates with complimentary mechanisms of action
  • Commence clinical development program for the treatment of autoimmune diseases
  • Present updated data on Phase 1 and 2 clinical trials at the American Society of Hematology Annual Meeting, in December 2015, held inOrlando, Florida

Financial Results for the Second Quarter 2015

At June 30, 2015 the Company had cash, cash equivalents, investment securities, and interest receivable of $110.6 million, which includes approximately $51.2 million of net proceeds from the utilization of the Company’s at-the-market (“ATM”) sales facility during the year (approximately$42 million of which was previously disclosed in connection with our last quarterly update), as compared to December 31, 2014 when we had $78.9 million.

Pro-forma cash, cash equivalents, investment securities, and interest receivable as of June 30, 2015 are approximately $126.4 million, including $15.8 million of net proceeds from the utilization of the ATM sales facility during the third quarter of 2015.

Our consolidated net loss for the second quarter ended June 30, 2015, excluding non-cash items, was approximately $10.9 million, which included approximately $4.8 million of manufacturing and CMC expenses in preparation for Phase 3 clinical trials and commercialization. The consolidated net loss for the second quarter ended June 30, 2015, inclusive of non-cash items, was $17.1 million, or $0.38 per diluted share, compared to a consolidated net loss of $12.0 during the comparable quarter in 2014, representing an increase in consolidated net loss of $5.1 million. The increase in consolidated net loss during the second quarter ended June 30, 2015 was primarily the result of other research and development expenses for TG-1101 and TGR-1202 increasing approximately $5.8 million and $1.3 million, respectively, over the comparable period in 2014. The increase in other research and development expenses related to TG-1101 was primarily the result of increased manufacturing and clinical trial expenses related to ongoing and planned future Phase 3 registration programs. These increases were partially offset by the $1.2 million of non-cash stock expense recorded in conjunction with the license to the IRAK4 inhibitors program during the quarter ended June 30, 2014 and a decrease of $1.5 million in non-cash compensation expense related to equity incentive grants over the comparable period in 2014.

Our consolidated net loss for the six months ended June 30, 2015, excluding non-cash items, was approximately $20.1 million, which included approximately $9.1 million of manufacturing and CMC expenses in preparation for Phase 3 clinical trials and commercialization. The consolidated net loss for the six months ended June 30, 2015, inclusive of non-cash items, was $31.7 million, or $0.73 per diluted share, compared to a consolidated net loss of $19.5 million during the comparable period in 2014, representing an increase in consolidated net loss of $12.2 million. The increase in consolidated net loss during the six months ended June 30, 2015 was primarily the result of other research and development expenses for TG-1101 and TGR-1202 increasing approximately $9.8 million and $2.5 million, respectively, over the comparable period in 2014. The increase in other research and development expenses related to TG-1101 was primarily the result of increased manufacturing and clinical trial expenses related to ongoing and planned future Phase 3 registration programs. (Original Source)

Shares of TG Therapeutics closed last Friday at $16.47. TGTX has a 1-year high of $20 and a 1-year low of $7.20. The stock’s 50-day moving average is $17.48 and its 200-day moving average is $15.92.

On the ratings front, TG Therapeutics has been the subject of a number of recent research reports. In a report issued on June 19, Brean Capital analyst Jonathan Aschoff reiterated a Buy rating on TGTX, with a price target of $28, which implies an upside of 70.0% from current levels. Separately, on the same day, MLV & Co.’s Arlinda Lee reiterated a Buy rating on the stock and has a price target of $22.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jonathan Aschoff and Arlinda Lee have a total average return of 6.9% and 0.0% respectively. Aschoff has a success rate of 47.8% and is ranked #500 out of 3728 analysts, while Lee has a success rate of 40.9% and is ranked #2554.

TG Therapeutics Inc is a biopharmaceutical company. It is engaged in the acquisition, development & commercialization of medically important pharmaceutical products for the treatment of cancer & other underserved therapeutic needs.