Chimerix(US:CMRX)2022-03-01 19:00Financial Data and Key Metrics Changes - The company reported a net loss of $39.5 million or $0.45 per basic and diluted share for Q4 2021, compared to a net loss of $11.7 million or $0.19 per share in Q4 2020 [37] - Revenues for Q4 2021 decreased to $46,000 from $1.1 million in the same period in 2020, primarily due to the completion of a BARDA research and development contract [38] - Research and development expenses increased to $34.3 million in Q4 2021 from $8.7 million in Q4 2020, largely due to a $20 million success milestone payment related to ONC201 [38] Business Line Data and Key Metrics Changes - The TEMBEXA program is expected to provide significant non-dilutive capital to fund oncology drug development, with a BARDA request for up to 1.7 million courses of treatment [10][11] - The ONC201 drug showed compelling response data in glioma, with a median tumor reduction of over 50% achieved at just over eight months after treatment initiation [13] - The DSTAT program's Phase III trial in frontline AML has faced slower enrollment due to COVID-19 staffing shortages, prompting a review of options to accelerate development [19] Market Data and Key Metrics Changes - The company is exploring international opportunities for TEMBEXA, particularly in Canada and Europe, as pandemic preparedness becomes increasingly critical [55] - The geopolitical uncertainty in Eastern Europe is noted as a consideration for potential stockpiling opportunities, although significant international demand is not expected in 2022 [56] Company Strategy and Development Direction - The company aims to initiate its first commercial product sale of TEMBEXA to the U.S. Strategic National Stockpile in Q2 2022, which is expected to enable full investment in its oncology pipeline [35][36] - The focus remains on advancing the oncology pipeline while also evaluating the antiviral library, particularly CMX521, which has shown promising preclinical efficacy against COVID-19 [21][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the BARDA negotiations, indicating that the process typically takes 60 to 90 days and that they feel good about their pricing proposal [41][42] - The company anticipates that 2022 will be pivotal, with expected revenue from TEMBEXA sales allowing for further investment in oncology programs [35][36] Other Important Information - The company has approximately $90 million in capital to fund operations as of December 2021, and has entered into a $50 million revolving credit line for additional financial flexibility [32][33] - The collaboration with the University of North Carolina has been highlighted as a key factor in evaluating the antiviral library's potential value [21] Q&A Session Summary Question: Confidence in BARDA negotiations timeline - Management indicated that negotiations typically take 60 to 90 days and expressed confidence in their proposal for pricing and delivery schedule [41][42] Question: Business development focus post-BARDA contract - The company will continuously evaluate external opportunities but will focus on internal projects, particularly ONC206 and ONC212, which may require additional investment [43] Question: Triggers for first TEMBEXA procurement - The initial shipment quantity is part of the negotiation, and future shipments will be subject to BARDA's orders based on the proposed manufacturing schedule [46] Question: Components needed for ONC201 regulatory filing - Key components include clinpharm activities, CMC activities, and a broader safety database beyond the initial efficacy analysis [47][48] Question: Safety data requirements for ONC201 submission - Management does not expect safety data from the upcoming Phase 3 trial to be required for the NDA submission, as prior safety evaluations have been sufficient [52][53] Question: Demand for TEMBEXA outside the U.S. - The company is exploring stockpiling opportunities in Canada and Europe, with ongoing discussions about potential procurement mechanisms [55][56] Question: Timing for initial studies and human data for CMX521 - Management indicated that they would provide more details on the timeline for human studies in subsequent calls, emphasizing the promising safety profile of CMX521 [59] Question: Details on the natural history study - The study will consist of two cohorts, one mirroring the ONC201 registration cohort and another broader population study to understand overall survival and progression [62][63]