Chimerix(US:CMRX)2022-08-09 03:16Financial Data and Key Metrics Changes - The company reported a net loss of $23.5 million or $0.27 per basic and diluted share for Q2 2022, compared to a net loss of $17.8 million or $0.21 per basic and diluted share in Q2 2021 [32] - Research and development expenses increased to $18 million for Q2 2022, up from $13.8 million in the same period in 2021, primarily driven by ongoing development related to ONC201 [32] - General and administrative expenses rose to $5.8 million for Q2 2022, compared to $4.4 million for the same period in 2021 [32] Business Line Data and Key Metrics Changes - The company achieved its first TEMBEXA product revenue of $35 million in July 2022, covered by two international agreements [6] - The company expects to realize at least $32 million of revenue in Q3 2022 from the TEMBEXA sales [28] Market Data and Key Metrics Changes - The company noted that the monkeypox outbreak has introduced new considerations for both BARDA and Chimerix, impacting their operational strategies [7] - The market research indicates high awareness of ONC201 among top prescribing neuro-oncologists, with expectations for rapid adoption if the ACTION study is successful [25][27] Company Strategy and Development Direction - The company is focused on advancing the ACTION study for ONC201, which targets a specific patient population with the H3 K27M mutation [9][14] - The company plans to revisit the potential for accelerated approval based on Phase 2 data with the FDA later in the year [24][40] - The company is actively working to finalize the BARDA contract, which is crucial for advancing its pipeline programs [31] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential success of the ACTION study, citing a high probability of success due to the focused patient population and robust study design [9][10] - The management acknowledged the ongoing discussions with international parties regarding TEMBEXA, particularly in light of the monkeypox outbreak [46][55] Other Important Information - The company welcomed Christopher Jordan as the new Vice President of Regulatory Affairs, bringing over 30 years of pharma experience [33] - The company has completed a robust safety assessment of ONC201 involving over 200 patients, revealing an attractive safety profile [13][21] Q&A Session Summary Question: Can either of the initial interim assessments at 164 or 246 events be enough to file for approval? - Management confirmed that these assessments are designed to provide statistical significance and could serve as the basis for regulatory submission and approval [35] Question: Can you talk more about the twice a week dosing and its rationale? - Management explained that the twice weekly dosing has shown safety in prior studies and aims to maximize efficacy by prolonging exposure [36][37] Question: Is there a timeframe mandated for administering ONC201 post-radiation? - Management clarified that patients will be enrolled within two to six weeks post-radiation, which is closer than the previous Phase 2 analysis [42][45] Question: What is the timeline for the BARDA contract and additional ex-U.S. revenues? - Management indicated that the BARDA contract needs to be finalized by September 30, 2022, and discussions for international opportunities are ongoing [46][47] Question: Have you set a meeting date with the FDA regarding accelerated approval? - Management stated they are preparing materials for the meeting and believe the ongoing Phase 3 study will support their case for accelerated approval [50][52] Question: What are the preclinical data for monkeypox and your thoughts on pursuing studies? - Management highlighted that TEMBEXA shows strong in vitro sensitivity to monkeypox and has demonstrated efficacy in animal models [54][56]