On August 9, 2017 TG Therapeutics, Inc. (NASDAQ:TGTX) reported its financial results for the second quarter ended June 30, 2017 and recent company developments (Press release, TG Therapeutics, AUG 9, 2017, View Source [SID1234520135]).
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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "The second quarter was a busy and exciting time for the Company, with the full presentation of the GENUINE data at ASCO (Free ASCO Whitepaper) coupled with additional important data presentations for TGR-1202 in various combinations. In addition, we were pleased to announce a successful outcome to the interim analysis in the UNITY-CLL program, allowing us to drop the two single agent arms and confirming that there were no safety issues requiring a modification of the trial. The UNITY-CLL study continues to enroll very robustly and we look forward to completing enrollment into the study by the end of the year." Mr. Weiss continued, "For the remainder of the year we look forward to our discussions with the FDA around the positive GENUINE Phase 3 results and the imminent commencement of the Phase 3 program of TG-1101 in RMS, for which we recently announced an SPA agreement with the FDA."
Recent Developments and Highlights
Presented positive data from the Phase 3 GENUINE Trial of TG-1101 in combination with Ibrutinib in patients with high risk Chronic Lymphocytic Leukemia (CLL)
Presented follow-up data for combination of TGR-1202 (umbralisib) plus Ibrutinib in patients with relapsed or refractory CLL and Mantle Cell Lymphoma (MCL)
Presented follow-up data for the triple combination of TG-1101, TGR-1202, and Bendamustine in patients with DLBCL and FL
Presented follow-up data from the chemo-free triple combination of TG-1101, TGR-1202, and Ibrutinib
Announced the successful outcome from the pre-planned interim analysis by an independent DSMB in the UNITY-CLL Phase 3 Trial which allowed for closing of enrollment to the single agent arms in this study
Presented preliminary data from the ongoing Phase 2 study of TG-1101 in patients with Multiple Sclerosis (MS)
Announced a Special Protocol Assessment (SPA) agreement with the FDA for a Phase 3 program for TG-1101 in relapsing forms of MS
Key Remaining 2017 Milestones
Complete the first interim analysis in the UNITY-NHL trial for the DLBCL cohort
Initiate a global Phase 3 program in MS, to be conducted under SPA agreement with the FDA
Present updated clinical data from the Phase 2 MS trial
Meet with the FDA to review the GENUINE Phase 3 data and discuss suitability for filing for accelerated approval
Complete enrollment into UNITY-CLL
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 Second Quarter 2017
Cash Position: Cash, cash equivalents, investment securities, and interest receivable were $86.5 million as of June 30, 2017. Pro-forma cash, cash equivalents, investment securities, and interest receivable as of June 30, 2017 are approximately $97.4 million, after giving effect to $10.9 million of net proceeds from the utilization of the Company’s at-the-market ("ATM") sales facility during the third quarter of 2017.
R&D Expenses: Research and development (R&D) expenses were $26.7 million and $49.4 million for the three and six months ended June 30, 2017, respectively, compared to $13.5 million and $25.2 million for the three and six months ended June 30, 2016. Included in research and development expense for the three and six months ended June 30, 2017 was $8.1 million and $13.3 million, respectively, of manufacturing and CMC expenses for Phase 3 clinical trials and potential commercialization, and $2.4 million and $3.4 million, respectively, in expenses related to commencement of the Phase 3 program for TG-1101 in MS. The increase in R&D expenses for both the three and six months ended June 30, 2017, is primarily due to the ongoing clinical development programs, including the start-up costs in preparation for the TG-1101 MS Phase 3 program, as well as manufacturing costs for both TG-1101 and TGR-1202.
G&A Expenses: General and administrative (G&A) expenses were $1.8 million and $6.8 million for the three and six months ended June 30, 2017, respectively, as compared to $2.5 million and $4.9 million for the three and six months ended June 30, 2016. The increase in G&A expenses for the six months ended June 30, 2017 relates primarily to non-cash compensation expenses related to equity incentive grants recognized during 2017. We expect G&A expenses to remain relatively constant through the remainder of 2017.
Net Loss: Net loss was $28.4 million and $56.1 million for the three and six months ended June 30, 2017, respectively, compared to a net loss of $15.9 million and $29.7 million for the three and six months ended June 30, 2016, respectively.
Financial Guidance: The Company believes its cash, cash equivalents, investment securities, and interest receivable inclusive of the proceeds raised subsequent to the quarter-end will be sufficient to fund the Company’s planned operations through 2018.