On May 5, 2017 TG Therapeutics, Inc. (NASDAQ:TGTX) reported its financial results for the first quarter ended March 31, 2017 and recent company developments (Press release, TG Therapeutics, MAY 5, 2017, View Source [SID1234518881]). Schedule your 30 min Free 1stOncology Demo! Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "2017 has been an exciting and busy year for us already, with both the announcement of the positive topline data from the Phase 3 GENUINE trial and the subsequent $89M capital raise. Having achieved these two important milestones, we believe the company is well positioned for a successful remainder of the year and beyond." Mr. Weiss continued, "We plan to focus our attention on advancing our clinical programs towards success and look forward to a data and news rich summer where we will be presenting a more detailed analysis of the GENUINE data, announcing the interim analysis data from both our UNITY-CLL Phase 3 trial and UNITY-DLBCL trial, as well as commencing our global Phase 3 program in MS."
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Recent Developments and Highlights
Received orphan drug designation for the combination of TG-1101 and TGR-1202 for the treatment of CLL and DLBCL
Announced the publication of clinical data from the Phase 1/2 trial of TG-1101 monotherapy in the British Journal of Haematology
Announced positive topline data from Phase 3 GENUINE study of TG-1101 in combination with ibrutinib in patients with high risk CLL
Solidified the Company’s balance sheet raising approximately $89M in gross proceeds through the combination of a public offering and an at-the-market sales facility
Presented preclinical data on our anti-PD-L1 monoclonal antibody at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting
Presented preliminary results, including B-cell depletion data from ongoing Phase 2 study of TG-1101 in patients with MS at the American Academy of Neurology (AAN) annual meeting
Reaffirming 2017 Milestones
Present updated clinical data including the full Phase 3 GENUINE data at a major medical meeting in the first half of 2017
Present clinical data from the Phase 2 Multiple Sclerosis (MS) trial
Initiate a global Phase 3 trial in MS
Complete the first interim analysis in the UNITY-CLL Phase 3 trial
Complete the first interim analysis in the UNITY-DLBCL trial
Meet with the FDA to review the Phase 3 GENUINE data and discuss suitability for filing for accelerated approval
Present new and updated data from ongoing trials at various scientific meetings throughout the year, including the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December
Financial Results for the First Quarter 2017
Cash Position: Cash, cash equivalents, investment securities, and interest receivable were $109.5 million as of March 31, 2017.
R&D Expenses: Research and development (R&D) expense was $22.7 million for the three months ended March 31, 2017 compared to $11.6 million for the three months ended March 31, 2016. Included in research and development expense for the three months ended March 31, 2017 and 2016, was $5.3 million and $4.3 million, respectively, of manufacturing and CMC expenses for Phase 3 clinical trials and potential commercialization. The increase in R&D expenses for the three months ended March 31, 2017, is primarily due to the ongoing clinical development programs and related manufacturing costs for TG-1101 and TGR-1202.
G&A Expenses: General and administrative (G&A) expense was $5.0 million for the three months ended March 31, 2017 as compared to $2.4 million for the three months ended March 31, 2016. The period-over-period increase in G&A expenses for the three months ended March 31, 2017 relates primarily to non-cash compensation expenses related to equity incentive grants recognized during 2017. Other G&A expenses for the three months ended March 31, 2017 remained relatively flat compared to the first quarter of 2016, and we expect G&A expenses to remain relatively constant through the remainder of 2017.
Net Loss: Net loss was $27.7 million for the three months ended March 31, 2017 compared to a net loss of $13.8 million for the three months ended March 31, 2016.
Financial Guidance: The Company believes its cash, cash equivalents, investment securities, and interest receivable of $109.5 million as of March 31, 2017 will be sufficient to fund the Company’s planned operations through 2018.