DBV Technologies(DBVT)2024-11-06 22:19Financial Position - DBV's cash and cash equivalents amount to 66.2 million as of June 30, 2024, reflecting a net decrease of $19.8 million[12]. - The company has incurred operating losses and negative cash flows from operations since inception, raising substantial doubt regarding its ability to continue as a going concern[14]. - The company plans to seek additional capital to support its operations and research and development efforts into Q1 2025[14]. Clinical Trials and Studies - The company expects to enroll approximately 300 - 350 subjects in the COMFORT Toddlers safety study, bringing the total safety database for the Viaskin Peanut patch in toddlers to approximately 600 subjects[4]. - A total of 654 subjects were enrolled in the VITESSE Phase 3 efficacy trial for children ages 4 – 7 years-old, with topline data anticipated in the fourth quarter of 2025[9]. - DBV plans to initiate the COMFORT Children safety study in the second quarter of 2025, aiming to enroll approximately 250 subjects to reach a total of about 600 subjects in the development program for 4 – 7 year-olds[9]. - The COMFORT Toddlers safety study is expected to be initiated in Q2 2025, with a focus on patch adhesion and wear time data collection[4]. Regulatory and Approval Processes - DBV intends to submit a meeting request to formalize the Accelerated Approval guidance provided by the FDA for the Viaskin Peanut patch in toddlers ages 1 – 3 years-old[3]. - The EMA confirmed that the completed EPITOPE study in 1 – 3 year-olds and a positive VITESSE study in 4 – 7 year-olds could support a Marketing Authorization Application for a 1 – 7 year-old indication[10]. - DBV's proposed labeling solution submitted to the FDA aims to link adhesion, efficacy, and safety to inform the product label[8].