G1 Therapeutics(US:GTHX)2020-02-27 02:50Financial Data and Key Metrics Changes - The company reported a net loss of $35.4 million for Q4 2019, compared to a net loss of $24.1 million for Q4 2018 [27] - The net loss for the full year 2019 was $122.4 million, up from a net loss of $85.3 million in 2018 [28] - Operating expenses for Q4 2019 were $36.6 million, compared to $26.1 million for Q4 2018 [28] - Cash and cash equivalents as of December 31, 2019, were $269.2 million, down from $369.3 million as of December 31, 2018 [32] Business Line Data and Key Metrics Changes - Research and development (R&D) expenses for Q4 2019 were $24.5 million, compared to $19.1 million for Q4 2018, with full-year R&D expenses at $89 million versus $70.7 million in the prior year [29][30] - General and administrative (G&A) expenses for Q4 2019 were $12.1 million, compared to $7 million for Q4 2018, with full-year G&A expenses at $40 million compared to $18.6 million in the prior year [31] Market Data and Key Metrics Changes - The company is on track to file a New Drug Application (NDA) and a Marketing Authorization Application (MAA) for trilaciclib in small cell lung cancer in 2020 [7][14] - The company plans to initiate a Phase III trial in colorectal cancer in Q4 2020, targeting a significant patient population [18] Company Strategy and Development Direction - The company aims to advance trilaciclib for small cell lung cancer and explore its potential in colorectal and breast cancer [35][37] - Rintodestrant is positioned as a potential best-in-class treatment for ER-positive HER2-negative breast cancer, with ongoing development plans [9][38] - The company is focusing resources on trilaciclib and rintodestrant while exploring partnerships for lerociclib [26][39] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the pending FDA review of trilaciclib and its potential to improve patient care [40] - The company anticipates an increase in cash burn in 2020 due to investments in regulatory filings and preparations for commercial launch [33] Other Important Information - The company expects to end 2020 with $110 million to $130 million in cash and cash equivalents [34] - The company is exploring non-dilutive opportunities to further capitalize the business [40] Q&A Session Summary Question: Clinical supply agreement with Pfizer - The current supply agreement is for the current study involving about 40 patients, with a step-by-step process for future studies [44][45] Question: Partnerships for lerociclib - The company is exploring both traditional CDK4/6 development areas and other potential applications for lerociclib [46] Question: Pre-commercial activities for trilaciclib - The company is focusing on educating providers about the impact of myelosuppression and plans to have a sales force of less than 50 people for the U.S. launch [51][53] Question: Expansion of trilaciclib indications - The company plans to meet with the FDA to discuss protocol and endpoints for colorectal cancer studies [57] Question: Preliminary data for rintodestrant - Preliminary data will focus on dose escalation and expansion cohorts, not including data on the combination with palbociclib [58] Question: I-SPY trial design - The I-SPY trial is an adaptive design that evaluates the efficacy of novel agents in combination with chemotherapy, with a focus on achieving a high probability of success for Phase III studies [62][66] Question: Efficacy bar for oral SERD in combination studies - The efficacy benchmark for the oral SERD in combination studies is expected to be equivalent to fulvestrant [70]