TG Therapeutics(US:TGTX)2019-05-10 21:03Financial Data and Key Metrics Changes - The company reported a net loss of approximately $33.3 million for Q1 2019, compared to a net loss of $41.5 million in Q1 2018, representing a decrease in loss of about 19% [10] - GAAP net loss for Q1 2019 was $35.2 million, or $0.43 per share, down from $0.59 per share in the same quarter of the previous year [10] - Cash position improved to $92.5 million as of March 31, 2019, with a pro forma cash position of approximately $116.7 million after additional fundraising [9][10] Business Line Data and Key Metrics Changes - Significant progress was made in the Marginal Zone Lymphoma (MZL) program, with positive top-line results and breakthrough designation from the FDA [13][14] - The UNITY-NHL Phase 2b pivotal trial of umbralisib monotherapy in MZL showed an overall response rate that met the study's primary endpoint [20] - The company is optimistic about the potential for accelerated approval filing for MZL by year-end [21] Market Data and Key Metrics Changes - The market for CD20 therapies in multiple sclerosis (MS) is projected to be substantial, with ofatumumab expected to generate approximately $4 billion in revenue in 2019 [29] - The company aims to capture a significant share of the market for B-cell cancers, with a focus on providing non-chemotherapy options [52] Company Strategy and Development Direction - The company plans to focus resources on the MZL data preparation for potential filing, while also preparing for future trials in CLL and follicular lymphoma [38] - The strategy includes building a robust commercial team to support the launch of umbralisib and U2 [89] - The company is developing a pipeline of early clinical drug candidates, including TG-1501, TG-1701, and TG-1801, with potential pivotal trials in 2020 [30][63] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing trials and the potential for successful outcomes, particularly in the UNITY-CLL study [24][50] - The company is focused on obtaining clarity from the FDA regarding the regulatory path for MZL and aims to present final data by year-end [95] - There is a strong belief that umbralisib offers a more attractive profile for patients compared to existing therapies, which could lead to significant market opportunities [52] Other Important Information - The company has received orphan drug designation for umbralisib for the treatment of MZL, enhancing its market position [18] - Positive interim data from the MS program was presented, showing ublituximab's well-tolerated profile with a median follow-up of 97.5 weeks [26] Q&A Session Summary Question: Can you discuss the timelines for the NHL study and the follow-up needed? - Management believes they can file for accelerated approval by year-end with a good nine months of follow-up on all patients, even if the FDA requests 12 months [35][36] Question: What is the confidence level regarding the PFS timeline? - Management stated that the control arm's performance is well-known, and they expect to see a 40% to 50% improvement in PFS, with the study potentially concluding by the end of the year [50][51] Question: How does the company view the competitive landscape for MZL? - Management feels confident about the path to approval for umbralisib, emphasizing the need for non-chemotherapy options in MZL treatment [52] Question: What are the commercialization plans for Marginal Zone in the U.S.? - The company plans to build a strong commercial team to effectively launch umbralisib and U2, leveraging available talent in the market [89] Question: What feedback has been received from physicians regarding MS therapies? - Positive feedback was received at AAN, with enthusiasm for the one-hour infusion of ublituximab noted as a significant advantage [71][72]