DBV Technologies(US:DBVT)2022-03-04 03:27Financial Data and Key Metrics Changes - As of December 31, 2021, cash and cash equivalents were $77.3 million, which is expected to support operations into the first quarter of 2023 [14] - Cash used in operating activities in the second half of 2021 was $41.7 million, representing a 54% decrease compared to the first half of 2020 [16] Business Line Data and Key Metrics Changes - The company is focused on the clinical regulatory development of the modified Viaskin Peanut patch, with a pivotal Phase 3 clinical study planned for initiation [9][10] - The company has successfully completed the pivotal trial protocol and is preparing for submission to the FDA [10][17] Market Data and Key Metrics Changes - The company acknowledges that its current stock price does not reflect the significant potential of the Viaskin platform, particularly Viaskin Peanut [21] Company Strategy and Development Direction - The company aims to balance extending its cash runway while preserving critical research and development efforts [12][13] - DBV Technologies is exploring various financing options, including non-dilutive strategies, to support its operations and development plans [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing discussions with the FDA regarding the pivotal trial protocol, indicating a positive engagement [11][25] - The company is excited about the potential of the EPITOPE study, which is expected to report results mid-year [26] Other Important Information - The company has exceeded its goal of reducing average monthly cash burn by 40% to 50% in the second half of 2021 compared to the first half of 2020 [15] Q&A Session Summary Question: Can you provide more details on the interactions with the FDA regarding the protocol? - Management indicated that discussions with the FDA have been productive, focusing on the core principles of the study, and they are pleased with the progress made [23][25] Question: When is the protocol expected to be submitted, and what are the next steps? - The protocol is ready for submission, and management expects to send it in short order after finalizing discussions with the FDA [25] Question: Can you provide an update on the EPITOPE program? - The EPITOPE study is due to report results mid-year, and management is looking forward to the outcomes [26] Question: What are the internal expectations for the EPITOPE study and its implications for younger children? - Management emphasized the importance of the one to three-year-old demographic and stated that they would reserve judgment on the data until it is available [27]