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].

Châtillon, France, June 12, 2025 DBV Technologies to Participate in Upcoming EAACI Congress 2025 DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT – CUSIP: 23306J309), a clinical-stage biopharmaceutical company, today announced upcoming participation in the European Academy of Allergy and Clinical Immunology (EAACI) Congress, June 13 – 16, 2025, in Glasgow, United Kingdom. DBV will present two posters and will also host a symposium and exhibit booth in the EAACI exhibit hall. ...

Core Insights - DBV Technologies has secured an agreement with the FDA regarding the safety exposure data required for the Biologics License Application (BLA) for the Viaskin® Peanut Patch in children aged 4 to 7 years, which accelerates the timeline for submission to the first half of 2026 [1][2][5] - The company reported unaudited financial results for the full year 2024, highlighting significant cash consumption and operating losses [8][11][22] FDA Agreement and Clinical Trials - The FDA has agreed that the safety data from the VITESSE Phase 3 study will be sufficient for the BLA, eliminating the need for the COMFORT Children supplemental safety study [2][5] - The VITESSE study is the largest Phase 3 clinical trial for peanut allergy in this age group, enrolling 654 participants, and is on track for topline results in Q4 2025 [3][4][5] - The BLA submission is now expected in the first half of 2026, potentially accelerating the product launch by approximately one year, pending FDA approval [2][5] Financial Results - As of December 31, 2024, cash and cash equivalents amounted to $32.5 million, down from $141.4 million in 2023, indicating a net cash consumption of $108.9 million primarily due to clinical trial expenses [11][12] - Operating income for 2024 was $4.2 million, a decrease from $15.7 million in 2023, attributed to the termination of a collaboration agreement and lower research tax credits [16][22] - The company recorded a net loss of $113.9 million for 2024, compared to a net loss of $72.7 million in 2023, with a net loss per share of $(1.17) [22][23] Research and Development - Operating expenses increased to $120.7 million in 2024 from $92.2 million in 2023, driven by research and development costs related to the ongoing VITESSE trial and preparatory activities for supplemental safety studies [18][21] - The company plans to pursue an Accelerated Approval pathway for the Viaskin peanut patch in toddlers aged 1 to 3 years, with a BLA submission expected in the second half of 2026 [6][29]