Chimerix(US:CMRX)2021-08-08 08:24Financial Data and Key Metrics Changes - The company reported a net loss of $17.8 million or $0.21 per basic and diluted share for Q2 2021, compared to a net loss of $10 million or $0.16 per basic and diluted share in Q2 2020 [19] - Revenues for Q2 2021 were $0.4 million, down from $1.4 million in the same period of 2020 [20] - Research and development expenses increased to $13.8 million in Q2 2021 from $8.6 million in Q2 2020, primarily due to the acquisition of Oncoceutics [20] Business Line Data and Key Metrics Changes - The company highlighted the acquisition of Oncoceutics and the initiation of the phase 3 DASH AML trial as significant progress [6] - The FDA approval of TEMBEXA as a medical countermeasure for smallpox was noted as a major milestone, marking the company's first FDA-approved drug [7] Market Data and Key Metrics Changes - The addition of TEMBEXA to the strategic national stockpile is seen as crucial for countering potential viral outbreaks, especially in light of COVID-19 [8] - The company is positioned to potentially expedite the time from RFP to contract for the procurement of TEMBEXA, with expectations of a shipment of up to $100 million into the stockpile [10] Company Strategy and Development Direction - The company aims to achieve several value-creating milestones throughout the remainder of the year, focusing on TEMBEXA, ONC201, and DSTAT [22] - There is a strategic emphasis on moving ONC201 into frontline therapy settings and exploring combination therapies to improve response rates [44][46] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing relationship with BARDA and the expectation to be ready for product shipment into the stockpile by the end of the year [23][53] - The company is optimistic about the potential for accelerated approval of ONC201 based on upcoming efficacy analyses [15] Other Important Information - The company ended Q2 2021 with approximately $140 million in capital to fund operations, indicating a strong financial position to support ongoing research and development [18] - The company is preparing for a potential procurement contract with BARDA, which could provide $80 million to $100 million annually [19] Q&A Session Summary Question: Are there any shifts in BARDA's priorities due to the Delta variant? - Management indicated that BARDA's contracting group has not been impacted by recent COVID-19 activity, and ongoing communication supports readiness for product shipment [23] Question: Can you comment on the enrollment numbers for the DSTAT program? - Management stated it is too early to identify enrollment trends as sites are still being activated, with an analysis of the first 80 patients expected in the second half of next year [24] Question: Will there be updates from the paraganglioma study related to ONC201? - Management confirmed that updates will come from the registration cohort and additional patients meeting specific criteria, but not from the paraganglioma study [25] Question: What is the anticipated median duration of drug for ONC201? - Management noted that the last patients in the cohort would be on the drug for over a year, indicating good follow-up maturity for assessing responses [40] Question: Can you elaborate on the analysis process for ONC201? - Management explained that the analysis will involve multiple reviewers to ensure accuracy, adhering to RANO criteria that include both imaging and clinical activity [48]