Chimerix(US:CMRX)2023-05-06 21:41Financial Data and Key Metrics Changes - For Q1 2023, the company reported a net loss of $21.4 million, an improvement from a net loss of $24.8 million in Q1 2022 [17] - Research and development expenses decreased to $18.8 million in Q1 2023 from $19 million in the same period in 2022 [17] - General and administrative expenses slightly increased to $5.7 million in Q1 2023 compared to $5.6 million in Q1 2022 [17] - The company ended Q1 2023 with approximately $246 million in cash and equivalents, with a projected year-end cash of around $200 million sufficient to fund operations into 2027 [18][19] Business Line Data and Key Metrics Changes - The ACTION study is progressing with regulatory approval in nine countries, including recent approval from the European Union [10] - The company is on track for the first efficacy analysis of the ACTION study in early 2025, which will include an overall survival assessment [10] - The dose escalation for ONC206 is expected to complete by the first half of 2024, with ongoing studies indicating potential for broader patient populations [15][19] Market Data and Key Metrics Changes - The company anticipates that approximately two-thirds of patients in the ACTION study will come from the U.S. or North America, with the potential for more than 120 global sites for patient enrollment [24][38] - The company has seen positive feedback and higher-than-expected interest in participation from sites in Europe, which may accelerate patient enrollment [38] Company Strategy and Development Direction - The company is focusing on expanding the potential market for ONC206 beyond H3K27M glioblastoma, with preclinical data suggesting broader activity [33] - The company aims to leverage findings from recent studies to inform future development strategies for both ONC201 and ONC206, particularly in indications exhibiting loss of H3K27 trimethyl [46] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing trials and the potential for ONC201 and ONC206, highlighting the significance of recent findings related to H3K27 trimethyl loss [11][14] - The company is preparing for a quick submission following the ACTION study, with a focus on maintaining capital efficiency and exploring additional investment opportunities [17][19] Other Important Information - The company is actively collecting tissue and blood samples from patients to support additional molecular assays and studies [45][46] - The financial impact of a previously announced reduction in force is expected to take effect in the current quarter [17] Q&A Session Summary Question: What is the expected split between U.S. and outside U.S. sites for the ACTION study? - Management estimates that most patients will come from the U.S. or North America, approximately two-thirds, with the potential for more than 120 global sites [24] Question: What is the timing for the PFS readout in relation to the OS assessment? - The PFS readout is expected to occur after the initial OS assessment, likely still during 2025 [26] Question: What are the ultimate market opportunities for ONC206 compared to ONC201? - ONC206 has demonstrated activity in non-H3K27M glioblastoma, suggesting a potential market that is significantly larger than that for ONC201 [28][33] Question: Can you provide more details on the future data updates for ONC206? - The focus will be on safety and the ability to escalate dosing safely, with potential efficacy signals expected to emerge as the study progresses [35]