Core Insights - DBV Technologies has filed its 2025 Half-Year Report with the French market authority, AMF, for the period ending June 30, 2025 [1] - The company is focused on developing treatment options for food allergies and other immunologic conditions, utilizing its proprietary VIASKIN patch technology [2][3] Company Overview - DBV Technologies is a clinical-stage biopharmaceutical company headquartered in Châtillon, France, with operations in North America [3] - The company is dedicated to addressing significant unmet medical needs related to food allergies, particularly through epicutaneous immunotherapy (EPIT) [2] - The VIASKIN patch aims to desensitize individuals to allergens by introducing microgram amounts of biologically active compounds through intact skin [2] Clinical Focus - DBV Technologies is currently conducting clinical trials for its VIASKIN Peanut product, targeting peanut allergic toddlers aged 1 to 3 years and children aged 4 to 7 years [2]

Core Viewpoint - DBV Technologies reported its financial results for the second quarter and half-year of 2025, highlighting a net loss and changes in operating income and expenses, while also discussing its ongoing development of the Viaskin Peanut patch for food allergies [1][19]. Financial Highlights - The interim condensed consolidated financial statements were prepared in accordance with U.S. GAAP and IFRS [2]. - Operating income for the six months ended June 30, 2025, was $2.2 million, a decrease from $2.6 million in the same period of 2024, primarily due to a lower French Research Tax Credit entitlement [3][4]. - Operating expenses increased to $69.9 million for the six months ended June 30, 2025, compared to $65.0 million for the same period in 2024, driven mainly by the launch of the COMFORT Toddlers supplemental safety study [5][6]. Net Loss - The company recorded a net loss of $69.0 million for the six months ended June 30, 2025, compared to a net loss of $60.5 million for the same period in 2024. The net loss per share was $(0.58) for the first half of 2025, compared to $(0.63) for the same period in 2024 [7][9]. Cash Position - Cash and cash equivalents amounted to $103.2 million as of June 30, 2025, a significant increase from $32.5 million as of December 31, 2024, reflecting a net increase of $70.7 million [10][14]. - The company announced a financing of up to $306.9 million to advance the Viaskin Peanut patch, with gross proceeds of $125.5 million received on April 7, 2025 [11][12]. Assets and Liabilities - As of June 30, 2025, total assets were $143.4 million, with liabilities of $57.2 million, resulting in shareholders' equity of $86.2 million [16].

Core Insights - DBV Technologies has appointed James Briggs as Chief Human Resources Officer, succeeding Caroline Daniere, to lead the company's transition from a development-stage biotechnology firm to a potential commercial organization [1][2] - James Briggs brings extensive experience in human capital strategy and organizational transformation, having previously served as a Partner at East Bay Human Capital and held executive roles at MNG Health, Ciox Health, and Ikaria Inc. [2] - The company is focused on developing treatment options for food allergies using its proprietary VIASKIN® patch technology, which aims to modify the immune response to allergens through epicutaneous immunotherapy [4] Company Overview - DBV Technologies is a clinical-stage biopharmaceutical company headquartered in Châtillon, France, with operations in North America [5] - The company is currently conducting clinical trials for its VIASKIN Peanut product aimed at peanut allergic toddlers and children [4] - DBV Technologies is committed to transforming the care of individuals with food allergies, addressing a significant unmet medical need [4]

Core Viewpoint - DBV Technologies has initiated the COMFORT Toddlers supplemental safety study for the Viaskin® Peanut patch, targeting peanut-allergic children aged 1 to 3 years, marking a significant step towards advancing this treatment option to market [1][3][4]. Group 1: Study Details - The COMFORT Toddlers study aims to enroll approximately 480 subjects across 80 to 90 study centers in the U.S., Canada, Australia, the UK, and Europe [2]. - The study is a Phase 3 double-blind, placebo-controlled safety trial designed to supplement safety and efficacy data from the completed Phase 3 EPITOPE study [3]. - The study duration is six months, followed by an optional 18-month open-label treatment phase, allowing for up to 24 months of active treatment for participants in the active group [3]. Group 2: Investigator Insights - Dr. Jeffrey Leflein, the Principal Investigator, expressed enthusiasm about the first subject being screened and highlighted the commitment to peanut-allergic children and their families [3]. - Dr. Julie Wang, Global Principal Investigator, noted the significant unmet need for this specific cohort, emphasizing the importance of the study [4]. - CEO Daniel Tassé stated that the data from this study will be crucial for a Biologics License Application (BLA) submission to the FDA, anticipated in the second half of 2026 [4]. Group 3: Company Background - DBV Technologies is a clinical-stage biopharmaceutical company focused on developing treatment options for food allergies, particularly through its proprietary Viaskin® patch technology [9]. - The company aims to address food allergies, which affect millions, including young children, by utilizing epicutaneous immunotherapy (EPIT™) to desensitize the immune system [9]. - DBV is committed to transforming the care of food-allergic individuals and is currently conducting clinical trials for the Viaskin Peanut patch in both toddlers and children [9].

Core Viewpoint - DBV Technologies has initiated the COMFORT Toddlers supplemental safety study for the Viaskin® Peanut patch, targeting peanut-allergic children aged 1 to 3 years, marking a significant step towards advancing this treatment option to market [1][3][4]. Group 1: Study Details - The COMFORT Toddlers study aims to enroll approximately 480 subjects across 80 to 90 study centers in the U.S., Canada, Australia, the UK, and Europe [2]. - The study is a Phase 3 double-blind, placebo-controlled safety trial designed to supplement safety and efficacy data from the completed Phase 3 EPITOPE study [3]. - The study duration is six months, followed by an optional 18-month open-label treatment phase, allowing for up to 24 months of active treatment for participants in the active group [3]. Group 2: Investigator Insights - Dr. Jeffrey Leflein, the Principal Investigator, expressed enthusiasm about the first subject being screened and highlighted the commitment to peanut-allergic children and their families [3][4]. - Julie Wang, Global Principal Investigator, noted the significant unmet need for this specific cohort, reinforcing the importance of the study [4]. Group 3: Regulatory and Future Plans - The data generated from the COMFORT Toddlers study is expected to support a Biologics License Application (BLA) submission to the FDA, anticipated in the second half of 2026 under the Accelerated Approval Pathway [4]. - The company is focused on advancing the development of the Viaskin Peanut patch, which aims to address food allergies through epicutaneous immunotherapy [9].