On March 8, 2018 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the fourth quarter and year ended December 31, 2017 and provided recent company developments along with a business outlook for 2018 (Press release, TG Therapeutics, MAR 8, 2018, View Source [SID1234524542]).
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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "2017 was a truly pivotal year for our company with the presentation of positive results from our first Phase 3 trial, the GENUINE trial, the completion of enrollment in our second Phase 3 trial, the UNITY-CLL trial, and the launch of our Phase 3 ULTIMATE trials in Multiple Sclerosis. These major milestones along with strong enrollment in our UNITY-NHL registration directed program sets the stage for an even more impactful 2018 and 2019." Mr. Weiss continued, "We are extremely pleased to enter 2018 with a healthy balance sheet and look forward to multiple value creating milestones this year, including presenting topline ORR data from our Phase 3 UNITY-CLL trial and, ideally, filing our first BLA and/or NDA later in the year."
2017 Highlights
● Orphan Drug Designation: Orphan drug designation was granted for the combination of ublituximab (TG-1101) and umbralisib (TGR-1202) for the treatment of Chronic Lymphocytic Leukemia (CLL) and Diffuse Large B-Cell Lymphoma (DLBCL).
● Ublituximab Publication: Data from the Phase 1/2 trial of ublituximab was published in the British Journal of Haematology.
● GENUINE Phase 3 Data: Positive data from the Phase 3 GENUINE trial of ublituximab in combination with ibrutinib in patients with high risk CLL was presented at the ASCO (Free ASCO Whitepaper) annual meeting and Lugano Lymphoma Conference.
● ULTIMATE Phase 3 Trials in MS: Received a Special Protocol Assessment (SPA) for the Phase 3 ULTIMATE I and II studies in relapsing forms of multiple sclerosis, commenced enrollment into the global studies and presented clinical and MRI data from the supportive Phase 2 trial of ublituximab in RMS at various conferences throughout the year.
● UNITY-CLL Phase 3 Enrollment: Full enrollment in the UNITY-CLL Phase 3 Trial was completed in October 2017
● Umbralisib Grant: Umbralisib was selected for a grant by the National Multiple Sclerosis Society to support the development of umbralisib as an oral B-Cell targeted treatment option in progressive Multiple Sclerosis (PMS).
● Anti-PD-L1 Entered the Clinic: The Company advanced its anti-PD-L1 monoclonal antibody into clinical development, with the first patient being dosed in a Phase I clinical trial.
Key Objectives for 2018
● UNITY-CLL Phase 3 Trial: We plan to present top-line overall response rate results from our UNITY-CLL Phase 3 trial in both front line and relapsed or refractory CLL and also prepare a BLA/NDA filing for accelerated approval.
● GENUINE Phase 3 BLA Filing: A Biologics Licensing Application (BLA) filing will be prepared for ublituximab plus ibrutinib for potential accelerated approval based on the results from GENUINE.
● UNITY-NHL: Aggressively enroll into all cohorts of the UNITY-NHL clinical trial with the goal of completing enrollment into all cohorts.
● ULTIMATE Phase 3 Trials: Aggressively recruit to our Phase 3 MS trials.
● Data Presentations: Present new and updated data from ongoing trials at various scientific meetings throughout the year.
Financial Results for the Fourth Quarter and Full Year 2017
● Cash Position: Cash, cash equivalents, investment securities, and interest receivable were $84.8 million as of December 31, 2017. Pro-forma cash, cash equivalents, investment securities, and interest receivable as of December 31, 2017 (excluding our first quarter 2018 operations) are approximately $114.6 million, after giving effect to $29.8 million of net proceeds from the utilization of the Company’s at-the-market ("ATM") sales facility during the first quarter of 2018.
● R&D Expenses: Research and development (R&D) expenses were $26.0 million and $102.5 million for the three and twelve months ended December 31, 2017, respectively, compared to $22.3 million and $69.2 million for the three and twelve months ended December 31, 2016, respectively. Included in research and development expenses for the three and twelve months ended December 31, 2017, in addition to our other clinical expenses, are $6.1 million and $26.6 million, respectively, of manufacturing and CMC expenses for Phase 3 clinical trials and potential commercialization. The increase in R&D expenses for both the three and twelve months ended December 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) expenses were $5.1 million and $16.3 million for the three and twelve months ended December 31, 2017, respectively, as compared to $1.8 million and $9.9 million for the three and twelve months ended December 31, 2016, respectively. The increase in G&A expenses for the three and twelve months ended December 31, 2017 relates primarily to non-cash compensation expenses related to equity incentive expense recognized during 2017.
● Net Loss: Net loss was $30.9 million and $118.5 million for the three and twelve months ended December 31, 2017, respectively, compared to a net loss of $23.7 million and $78.3 million for the three and twelve months ended December 31, 2016, respectively.
● Financial Guidance: The Company believes its cash, cash equivalents, investment securities, and interest receivable on hand as of December 31, 2017, inclusive of the proceeds raised subsequent to the year-end will be sufficient to fund the Company’s planned operations through mid-2019.
Conference Call Information
The Company will host an investor conference call today, Thursday, March 8, 2018 at 8:30am ET, to discuss the Company’s 2017 financial results and provide a business outlook for 2018.
In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics Year-End 2017 Earnings Call. A live audio webcast of this conference call will be available on the Events page, located within the Investors & Media section, of the Company’s website at www.tgtherapeutics.com. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call