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Dec 31, 2020
TG Therapeutics Q4 2020 Earnings Report
Announced financial results for the fourth quarter and year ended December 31, 2020, along with recent company developments and a business outlook for 2021.
Key Takeaways
TG Therapeutics reported a net loss of $88.2 million for the fourth quarter of 2020. The company's cash, cash equivalents, and investment securities totaled $605.4 million as of December 31, 2020, which is expected to fund operations into 2023.
Received FDA accelerated approval for UKONIQ™ (umbralisib) in relapsed/refractory MZL & FL.
Presented results from the UNITY-CLL Phase 3 trial showing U2 significantly improving progression-free survival (PFS) over obinutuzumab plus chlorambucil.
Announced that the Phase 3 ULTIMATE I & II trials met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate (ARR) over a 96-week period compared to teriflunomide in patients with relapsing forms of multiple sclerosis (RMS).
Ended the year with more than $600 million in cash, cash equivalents and investment securities.
TG Therapeutics
TG Therapeutics
Forward Guidance
TG Therapeutics plans to continue the commercialization of UKONIQ, present results from the ULTIMATE I & II Phase 3 trials, complete the rolling BLA submission of ublituximab, complete enrollment in the ULTRA-V Phase 2b trial, and continue to advance early pipeline candidates.
Positive Outlook
- Continue the commercialization of UKONIQ in relapsed/refractory MZL and FL and expand commercialization capabilities in preparation for a potential launch of ublituximab
- Present results from the ULTIMATE I & II Phase 3 trials evaluating ublituximab in RMS and prepare a BLA submission
- Complete the rolling BLA submission of ublituximab, in combination with umbralisib, for the treatment of patients with CLL
- Complete enrollment in the ULTRA-V Phase 2b trial and begin a Phase 3 trial evaluating the triple combination of U2 plus venetoclax
- Continue to advance our early pipeline candidates including TG-1501 (cosibelimab), TG-1701 and TG-1801