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Mar 31, 2020
TG Therapeutics Q1 2020 Earnings Report
TG Therapeutics reported financial results for Q1 2020 and provided a business update.
Key Takeaways
TG Therapeutics reported a net loss of $51.1 million for the first quarter of 2020. The company highlighted positive topline results from the UNITY-CLL Phase 3 trial and the initiation of a rolling NDA submission for umbralisib in MZL and FL. They ended the quarter with $78.3 million in cash, cash equivalents and investment securities, and pro forma cash of $154.3 million.
Reported positive topline results from the UNITY-CLL Phase 3 trial evaluating U2 in patients with CLL.
Initiated a rolling NDA submission for umbralisib to treat adult patients with previously treated MZL and FL.
Strengthened balance sheet with more than $75 million in gross proceeds through the Company’s At-the-Market (ATM) facility.
Cash, cash equivalents and investment securities were $78.3 million as of March 31, 2020.
TG Therapeutics
TG Therapeutics
Forward Guidance
TG Therapeutics anticipates several key milestones over the next 9 months, including the release of topline data from the ULTIMATE MS Phase 3 program, submission of an NDA/BLA for U2 in CLL, and potential approval for umbralisib in MZL and FL.
Positive Outlook
- Complete rolling NDA submission for umbralisib in patients with previously treated MZL and FL, in the first half of 2020.
- Report topline results from the Phase 3 ULTIMATE I & II trials in RMS, in the second half of 2020.
- Present full data from the UNITY-CLL Phase 3 trial at a major medical meeting, by year-end 2020.
- Present full data from the FL and MZL umbralisib monotherapy cohorts of the UNITY-NHL trial at a major medical meeting, by year-end 2020.
- Target an NDA/Biologics Licensing Application (BLA) submission of U2 for the treatment of patients with CLL (including both previously untreated and relapsed/refractory patients), by year end 2020.
Challenges Ahead
- The risk that the final analysis of the UNITY-NHL MZL or FL cohorts will be insufficient to support FDA approval of umbralisib.
- The risk that we are unable to successfully deliver the complete data set from the UNITY-CLL trial or prepare a regulatory submission on schedule as planned.
- The risk that the final analysis of the UNITY-CLL study will be insufficient to support FDA approval of the combination regimen of umbralisib and ublituximab in CLL.
- The risk that any of our other registration-directed clinical trials, including the ULTIMATE I & II trials, as designed or amended may not be sufficient or acceptable to support regulatory submission or approval.
- The risk that achievement of the milestones we project will be delayed due to a variety of factors, including, without limitation, the evolving and unpredictable COVID-19 pandemic.