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Sep 30, 2020
TG Therapeutics Q3 2020 Earnings Report
TG Therapeutics reported financial results for Q3 2020 and provided a business update.
Key Takeaways
TG Therapeutics announced positive results from the UNITY-CLL Phase 3 trial and the UNITY-NHL trial, supporting the NDA submission for umbralisib monotherapy. The company is preparing for a potential launch in relapsed/refractory MZL and FL, with PDUFA goal dates set in February 2021 and June 2021, respectively. The company's proforma cash position was approximately $325 million as of September 30, 2020.
UNITY-CLL Phase 3 trial met its primary endpoint of improvement in progression-free survival.
UNITY-NHL trial data supported NDA submission for umbralisib monotherapy.
FDA accepted the Company’s New Drug Application (NDA) for umbralisib as a treatment for patients with previously treated MZL and FL.
The MZL indication, under Breakthrough Therapy Designation (BTD), has been accepted for Priority Review and has a Prescription Drug User Fee Act (PDUFA) goal date of February 15, 2021.
TG Therapeutics
TG Therapeutics
Forward Guidance
TG Therapeutics anticipates several key objectives for the remainder of 2020 and early 2021.
Positive Outlook
- Report topline results from the Phase 3 ULTIMATE I & II trials in Multiple Sclerosis
- Present full data from the UNITY-CLL Phase 3 trial and from the FL and MZL single agent umbralisib cohorts of the UNITY-NHL trial at ASH 2020 as well as data from our triple therapy combinations of U2 plus venetoclax and U2 plus 1701, our BTK inhibitor
- 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)
- Complete enrollment in ULTRA-V Phase 2b trial
- Continue to advance our early pipeline candidates including our anti-PD-L1 monoclonal antibody, cosibelimab (TG-1501), our covalently-bound Bruton’s Tyrosine Kinase (BTK) inhibitor, TG-1701, and our anti-CD47/CD19 bispecific antibody, TG-1801
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, or, if supportive of approval, will not be supportive of a differentiated profile
- 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 or, if supportive of approval, will not be supportive of a differentiated profile
- The risk that any of our other registration-directed clinical trials, including the ULTIMATE I & II trials, as designed or amended may not be positive, or if positive, may not be sufficient or acceptable to support regulatory submission or approval of ublituximab in relapsing forms of Multiple Sclerosis
- The risk that we are not able to successfully and cost effectively complete all the preclinical, clinical and manufacturing requirements necessary to support our anticipated regulatory submissions