Chimerix(US:CMRX)2023-11-02 18:50Financial Data and Key Metrics Changes - The company ended the third quarter with $217 million in cash and equivalents, aligning with previous guidance of approximately $200 million by year-end [22] - The company continues to expect its cash balance to support operations into the end of 2026 and through expected clinical endpoints [10] Business Line Data and Key Metrics Changes - The ACTION study of ONC201 has 113 sites open across 12 countries, exceeding the prior guidance of 100 sites by September 30 [19] - Enrollment in the ACTION study is progressing, with first and second interim overall survival data expected in 2025 [19] Market Data and Key Metrics Changes - The company has seen strong engagement in Europe, evidenced by rapid site activations, while Canada has been slower due to regulatory factors [53] - The company participated in the European Association for Neuro-Oncology Conference, which saw record attendance and increased site activity post-conference [5][4] Company Strategy and Development Direction - The company is preparing for the potential commercialization of ONC201 and is finalizing the recruitment of a Chief Commercial Officer [8] - The company is focused on advancing ONC201 and exploring business development opportunities to broaden its pipeline [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing ACTION study and the potential of ONC201 as a first-in-class therapy for H3 K27M-mutant glioma [13] - The management highlighted the importance of in-person medical conferences for driving engagement and awareness in the neuro-oncology community [5] Other Important Information - The company has approved protocol amendments for ONC206 dose escalation studies, allowing for a more intense dosing schedule [9] - A recent publication in Cancer Discovery supports the efficacy of ONC201 in frontline settings, showing a survival rate of 21.7 months for treated patients compared to 12 months for those who did not receive the treatment [12][11] Q&A Session Summary Question: When is full enrollment expected for the ACTION study? - Management has not provided specific guidance but expects first interim efficacy data in the first half of 2025, suggesting a similar timeline for full enrollment [29] Question: What is the status of ONC206 enrollment? - There are three separate arms ongoing in the Phase I studies, and management expects enrollment to be completed in the first half of 2024, with safety data likely released first [31][32] Question: How long has the GBM patient been on ONC206 therapy? - The patient has been on study for about 1.5 years and has graduated to dose level 4, showing a durable response [36] Question: What data will be presented at the upcoming SNO conference? - Management expects at least three oral presentations on ONC201, focusing on its role as a combinatorial backbone in DMG and associated safety and outcomes [39] Question: What is the expected expense trajectory for the next few quarters? - The company anticipates a similar cash burn rate of approximately $15 million to $17 million per quarter, with a potential uptick in expenses as preparations for commercialization begin [76][78]