TG Therapeutics(TGTX) - 2019 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The net loss for Q2 2019 was approximately $36.2 million or $0.42 per share, compared to a net loss of $44.1 million or $0.59 per share in Q2 2018, indicating a reduction in net loss year-over-year [7][10] - For the six months ended June 30, 2019, the GAAP net loss was $71.4 million or $0.85 per share, down from $85.7 million or $1.18 per share in the same period of 2018 [10] - The company had cash, cash equivalents, and investment securities of $85 million as of June 30, 2019, with a pro forma cash position of approximately $97 million after raising additional proceeds [12][13] Business Line Data and Key Metrics Changes - R&D spending has decreased as registration trials in oncology and multiple sclerosis (MS) progressed, contributing to the reduced net loss compared to 2018 [8] - The company expects quarterly cash burn to average roughly $25 million for the remainder of 2019 [13] Market Data and Key Metrics Changes - The company is preparing for the NDA filing for umbralisib for accelerated approval, with a significant patient population in need of treatment for marginal zone lymphoma [27] - The market for umbralisib is estimated to have approximately 3,000 patients relapsing each year in the U.S. alone [27] Company Strategy and Development Direction - The company is focused on building its commercial team and preparing for the NDA filing around year-end, with several important milestones expected within the next 12 months [15][16] - The company aims to establish a strong presence in the marginal zone lymphoma market, viewing it as a relatively open field with significant potential [61] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming NDA submissions and the potential for successful outcomes in ongoing trials, particularly for umbralisib and the UNITY-CLL trial [28][29] - The company is confident in the tolerability and efficacy of its lead compounds, with encouraging data from clinical trials [30][31] Other Important Information - The company has received breakthrough therapy designation and orphan drug designation from the FDA for umbralisib in the treatment of marginal zone lymphoma [26] - The company is also advancing its early development pipeline with three compounds in Phase 1 and dose expansion cohorts [33] Q&A Session Summary Question: Update on timelines for follicular lymphoma - Management indicated that the expected follow-up for follicular lymphoma would likely land in late Q1 or Q2, depending on FDA expectations [38] Question: Control arms comparisons for ublituximab in CLL study - Management provided data from comparable trials, estimating a likely progression-free survival (PFS) for the control arm between 20 to 22 months [45] Question: Data expectations for venetoclax and U2 - Management anticipates around 10 patients with at least a year of follow-up, expecting a 50% complete response (CR) or minimal residual disease (MRD) negative rate [50] Question: Marginal zone lymphoma filing steps and competitive landscape - Management discussed the rate-limiting steps for the filing and noted that the market is relatively open, with umbralisib positioned as a strong treatment option [56][61] Question: Update on PDL-1 inhibitor 1501 - Management confirmed that a Phase I study is open in the U.S. for hematologic malignancies, with a combination study ongoing [83] Question: R&D spending outlook for next year - Management expects R&D spending to continue to decline as clinical trials wind down, with a modest increase in commercial activities anticipated [94]