Chimerix(US:CMRX)2024-05-01 15:28Financial Data and Key Metrics Changes - The company reported a net loss of $21.9 million or $0.25 per basic and diluted share for Q1 2024, compared to a net loss of $21.4 million or $0.24 per share in Q1 2023 [39] - Research and development expenses remained flat at $18.8 million compared to the same period in 2023, while general and administrative expenses decreased to $5.5 million from $5.7 million [39][39] Business Line Data and Key Metrics Changes - The Phase 1 evaluation of ONC206 is on track, with dose escalation studies completed without limiting safety signals, now moving to an intensified dose schedule [2][3] - The ACTION study, which is central to the company's strategy, is progressing with steady state accrual and is expected to provide the first interim readout next year [8] Market Data and Key Metrics Changes - The company is exploring global registration pathways for dordaviprone (ONC201) to accelerate access, particularly in Australia, where a provisional registration process is underway [81][82] - The company anticipates that the filing for provisional registration in Australia could be submitted by the end of 2024, with potential commercial availability in 2026 [89] Company Strategy and Development Direction - The primary strategic focus for the company this year is the continued enrollment in the Phase 3 ACTION study, which addresses a significant unmet need in neuro-oncology [77][79] - The company is preparing development strategies for ONC206, with expectations to share details before the end of the year as they approach a Phase 2 investment decision [10][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the safety profile and therapeutic window of ONC206, indicating that the ongoing studies are expected to yield promising results [10][12] - The company remains disciplined in financial management, with a cash balance sufficient to support operations into Q4 2026 [38] Other Important Information - The company has $188.2 million in capital available to fund operations and no outstanding debt, positioning it as one of the most capital-efficient Phase 3 companies in its peer group [13] - The company is leveraging clinical experience from dordaviprone to inform the development of ONC206, focusing on tumors that do not harbor the H3 K27M mutation [11][12] Q&A Session Summary Question: Enrollment for the Phase 3 ACTION study - Management confirmed that the additional five sites added were part of the initial tranche and are strategically located to optimize enrollment, with expectations for the first interim overall survival (OS) data in 2025 [16][24] Question: Filing application submission to the Australia TGA - Management discussed the gating factors for the application, indicating that the submission is not contingent on Phase 3 trial data but rather on ensuring the trial is well underway [17][47] Question: Commercial opportunity in Australia - Management expressed optimism regarding the commercial potential in Australia, highlighting the efficient network in the neuro-oncology community and the potential for in-country collaborations [49][50] Question: Future studies for ONC206 - Management indicated that both adult and pediatric trials for ONC206 are proceeding in parallel, with expectations to report safety and pharmacokinetic data from both studies [51][51] Question: Overlap between H3 K27M and BRAF alteration - Management clarified that H3 K27M does not co-occur with other actionable mutations, and the focus remains on the frontline setting for the Phase 3 trial [64][64]