Financial Data and Key Metrics Changes - As of June 30, 2023, cash and cash equivalents were $174 million, a decrease of $35.2 million from $209.2 million as of December 31, 2022 [47] - Operating activities used $46.4 million in cash, primarily driven by clinical R&D, with a significant component being the initiation of the VITESSE Phase 3 trial [47] - Cash used for operations in the first half of 2023 increased by $34.7 million compared to the same period in 2022 [47] Business Line Data and Key Metrics Changes - The Viaskin Peanut program is advancing in parallel for toddlers (ages 1-3) and children (ages 4-7), with independent clinical and regulatory paths for each [43] - The supplemental safety study for toddlers will include approximately 400 subjects, while the study for children will include about 270 subjects, bringing the total safety database to approximately 600 subjects on active treatment [55][56] Market Data and Key Metrics Changes - The company received €24.8 million for reimbursement of French research tax credits for the years 2019-2021 during the first half of 2022 [21] - The company raised $7.8 million from the issuance and sale of new ordinary shares in the form of American Depositary Shares on June 16, 2023 [21] Company Strategy and Development Direction - The successful completion of the supplemental COMFORT Toddlers safety study is viewed as a crucial step towards filing a Biologics License Application (BLA) for marketing approval [48] - The company is focused on maximizing the efficiency of its spending and maintaining disciplined cash management to support ongoing clinical work [36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing progress of the VITESSE trial, with expectations to have the last patient enrolled in the first half of next year and top-line results anticipated in the first half of 2025 [51] - The FDA has not raised specific safety concerns regarding the Viaskin Peanut development program, indicating a consistent communication from the agency [55] Other Important Information - The Phase 3 EPITOPE study results were published in the New England Journal of Medicine, highlighting the efficacy of Viaskin Peanut [44] - The company is actively finalizing protocols for the supplemental safety studies and expects to submit them to the FDA for a formal 90-day review [46] Q&A Session Summary Question: What protocol details are being aligned with the FDA? - The company is working to finalize the protocol and will submit it to the FDA once completed [50] Question: Will the cash runway guidance change with the agreement on high-level details from the FDA? - Management indicated that the feedback from the FDA does not change their clinical trial planning or financial projections [27] Question: Can you provide an update on the VITESSE enrollment? - Enrollment is proceeding as expected, with no changes to the previously provided guidance regarding patient enrollment timelines [51]
DBV Technologies(DBVT) - 2023 Q2 - Earnings Call Transcript