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Dec 31, 2019
TG Therapeutics Q4 2019 Earnings Report
TG Therapeutics reported financial results for Q4 and year ended December 31, 2019, along with business updates and outlook for 2020.
Key Takeaways
TG Therapeutics reported a net loss of $39.6 million for the fourth quarter of 2019. The company's cash, cash equivalents, and investment securities totaled $140.4 million as of December 31, 2019, expected to fund operations well into 2021. Key objectives for 2020 include reporting topline PFS results from the Phase 3 UNITY-CLL trial and completing the rolling NDA submission for umbralisib in patients with previously treated MZL and FL.
Reported positive outcomes for umbralisib in both previously treated marginal zone lymphoma and follicular lymphoma from the UNITY-NHL trial.
Commenced a single rolling submission with the FDA based on UNITY-NHL trial data.
Awaiting topline results from Phase 3 programs in CLL and MS.
Potentially first FDA approval around year-end.
TG Therapeutics
TG Therapeutics
Forward Guidance
TG Therapeutics anticipates several key milestones in 2020, including data readouts and regulatory submissions.
Positive Outlook
- Report topline PFS results from the Phase 3 UNITY-CLL trial evaluating U2 in patients with frontline and previously treated CLL.
- Target a potential New Drug Application (NDA)/Biologics Licensing Application (BLA) submission by year-end if UNITY-CLL trial is successful.
- 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.
- Continue to advance early pipeline candidates including TG-1501 (cosibelimab), TG-1701 and TG-1801.
Challenges Ahead
- The risk that the interim data from the UNITY-NHL MZL cohort will not be reproduced when the final analysis is conducted on all patients.
- The risk that the final analysis of the UNITY-NHL MZL or FL cohorts will be insufficient to support a filing for accelerated approval.
- The risk that umbralisib will not receive accelerated approval based on data from the UNITY-NHL MZL or FL cohorts.
- The risk that PFS data from UNITY-CLL will not be positive or, if positive, will not be accepted for filing by the FDA.
- The risk that the anticipated timeline for completing the submission of the umbralisib NDA in MZL and FL based on the UNITY NHL data will be delayed.