[DBV Technologies Second Quarter and Half-Year 2025 Financial Results](index=1&type=section&id=DBV%20Technologies%20Second%20Quarter%20and%20Half-Year%202025%20Financial%20Results) [Financial Highlights](index=1&type=section&id=Financial%20Highlights) DBV Technologies reported a net loss of $69.0 million in H1 2025, with cash increasing to $103.2 million, yet faces going concern doubts [Operating Income](index=1&type=section&id=Operating%20Income) - Operating income for the first six months of 2025 decreased compared to the same period in 2024, primarily due to a lower French Research Tax Credit as more study activities were conducted in North America and were therefore ineligible[4](index=4&type=chunk) Operating Income (U.S. GAAP) | Operating Income (U.S. GAAP) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | **In millions of USD** | | | | Research tax credit | $2.2 | $2.6 | | Operating income | $2.2 | $2.6 | [Operating Expenses](index=2&type=section&id=Operating%20Expenses) - Operating expenses for the first six months of 2025 increased by **$4.9 million** year-over-year, mainly driven by the launch of the COMFORT Toddlers supplemental safety study[6](index=6&type=chunk) Operating Expenses (U.S. GAAP) | Operating Expenses (U.S. GAAP) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | **In millions of USD** | | | | Research & Development | $(55.2) | $(46.8) | | Sales & Marketing | $(0.7) | $(1.7) | | General & Administrative | $(14.1) | $(16.4) | | **Total Operating Expenses** | **$(69.9)** | **$(65.0)** | [Net Loss and Net Loss Per Share](index=2&type=section&id=Net%20Loss%20and%20Net%20Loss%20Per%20Share) - The company's net loss widened for the first half of 2025 compared to the prior year, while the net loss per share showed a slight improvement[8](index=8&type=chunk) Net Loss Metrics (U.S. GAAP) | Net Loss Metrics (U.S. GAAP) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net loss (in millions of USD) | $(69.0) | $(60.5) | | Basic / diluted net loss per share (USD/share) | $(0.58) | $(0.63) | [Cash Position and Going Concern](index=2&type=section&id=Cash%20Position%20and%20Going%20Concern) - The company's cash and cash equivalents significantly increased to **$103.2 million** as of June 30, 2025, from **$32.5 million** at the end of 2024, primarily due to a new financing arrangement[10](index=10&type=chunk)[14](index=14&type=chunk) - In March 2025, the company announced a financing of up to **$306.9 million** to advance its Viaskin® Peanut patch, with initial gross proceeds of **$125.5 million** received in April 2025[11](index=11&type=chunk) - Despite the recent financing, the company states there is substantial doubt about its ability to continue as a going concern, as its current cash is estimated to fund operations only into the **second quarter of 2026**[10](index=10&type=chunk)[11](index=11&type=chunk) [Condensed Consolidated Financial Statements](index=4&type=section&id=Condensed%20Consolidated%20Financial%20Statements) Condensed financial statements as of June 30, 2025, show total assets of **$143.4 million** and a net loss of **$69.0 million** [Statements of Financial Position](index=4&type=section&id=Statements%20of%20Financial%20Position) Balance Sheet Highlights (U.S. GAAP) | Balance Sheet Highlights (U.S. GAAP) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **In millions of USD** | | | | Cash & cash equivalents | $103.2 | $32.5 | | **Total Assets** | **$143.4** | **$65.7** | | **Total Liabilities** | **$57.2** | **$38.3** | | **Shareholders' equity** | **$86.2** | **$27.4** | [Statements of Operations](index=4&type=section&id=Statements%20of%20Operations) Income Statement (U.S. GAAP) | Income Statement (U.S. GAAP) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | **In millions of USD** | | | | Operating income | $2.2 | $2.6 | | Research & Development | $(55.2) | $(46.8) | | Operating expenses | $(69.9) | $(65.0) | | **Net loss** | **$(69.0)** | **$(60.5)** | | **Basic/diluted net loss per share** | **$(0.58)** | **$(0.63)** | [Company Overview and Forward-Looking Statements](index=5&type=section&id=Company%20Overview%20and%20Forward-Looking%20Statements) DBV Technologies, a clinical-stage biopharmaceutical company, focuses on Viaskin Peanut development and includes standard forward-looking statements - DBV Technologies is a clinical-stage biopharmaceutical company developing treatments for food allergies via its proprietary epicutaneous immunotherapy (EPIT) platform, Viaskin[18](index=18&type=chunk) - The company's primary focus is on the clinical trials of Viaskin Peanut for peanut-allergic toddlers (1-3 years) and children (4-7 years)[18](index=18&type=chunk) - The press release contains forward-looking statements regarding its financial condition and the potential of Viaskin® Peanut, which involve substantial risks as its product candidates are not yet authorized for sale[20](index=20&type=chunk)

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].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________ FORM 10-Q ____________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to _______________ Commission file number 001-36697 DBV TECHNOLOGIES S.A. (Exact name of registrant as ...

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].

Core Viewpoint - DBV Technologies will participate in the EAACI Congress 2025, presenting new data on its VIASKIN® peanut patch and hosting a symposium focused on peanut allergy research [1][3][4] Company Overview - DBV Technologies is a clinical-stage biopharmaceutical company focused on developing treatment options for food allergies and other immunologic conditions, utilizing its proprietary VIASKIN® patch technology [7][8] - The company aims to address food allergies through epicutaneous immunotherapy (EPIT™), which introduces microgram amounts of allergens to the immune system via the skin [7] Upcoming Presentations - At the EAACI Congress, DBV will present data from the EPITOPE open-label extension trial, highlighting reduced rates of reactions from accidental peanut consumption with the VIASKIN® peanut patch [2][4] - The APTITUDE study results will also be shared, evaluating the sensitivity, specificity, and safety of the VIASKIN® patch for diagnosing non-IgE mediated cow's milk allergy in infants [2][4] Symposium Details - The symposium titled "Peanut Allergy: Recent Research Highlights" will be co-chaired by Prof Gideon Lack and Prof Alexandra Santos, featuring discussions on the clinical relationship between allergists and food-allergic patients [3][5] - Presentations will include insights on epicutaneous immunotherapy and new clinical data related to peanut allergy [6][7] Clinical Data Highlights - Year 2 data from the EPITOPE trial will demonstrate real-world protective effects of the VIASKIN® peanut patch in peanut-allergic toddlers, showing further reductions in accidental peanut consumption-related reactions [4][7] - The APTITUDE study, despite early termination due to enrollment challenges, is viewed as a positive step in demonstrating the potential of the VIASKIN® patch in food allergy management [4][7]

Core Points - DBV Technologies has filed an addendum to the 2024 Universal Registration Document with the French market authority AMF [1] - The addendum updates the Corporate Governance Report regarding exceptional compensation granted to the CEO, pending approval at the Annual Combined General Meeting on June 11, 2025 [2] Company Overview - DBV Technologies is a clinical-stage biopharmaceutical company focused on developing treatments for food allergies and other immunologic conditions with significant unmet medical needs [4] - The company utilizes its proprietary Viaskin technology platform to address food allergies through epicutaneous immunotherapy (EPIT™), which aims to desensitize the immune system to allergens [4] - Ongoing clinical trials include Viaskin Peanut for peanut allergic toddlers and children [4] Operations and Trading - DBV Technologies is headquartered in Châtillon, France, with operations in Warren, NJ, North America [5] - The company's ordinary shares are traded on Euronext Paris and its American Depositary Shares (ADSs) on the Nasdaq Capital Market [5]

Company Overview - DBV Technologies S.A. (DBVT) is a notable stock within the Medical sector, which consists of 999 companies and currently ranks 4 in the Zacks Sector Rank [2] - The company is categorized under the Medical - Biomedical and Genetics industry, which includes 506 stocks and is ranked 70 in the Zacks Industry Rank [6] Performance Metrics - DBVT has experienced a year-to-date gain of approximately 210.7%, significantly outperforming the average loss of 4.4% in the Medical sector [4] - The Zacks Consensus Estimate for DBVT's full-year earnings has increased by 78.9% over the past quarter, indicating a positive shift in analyst sentiment [4] Comparison with Peers - Hims & Hers Health, Inc. (HIMS) is another Medical stock that has shown strong performance, with a year-to-date return of 153.1% and a Zacks Rank of 2 (Buy) [5] - The Medical Info Systems industry, to which HIMS belongs, has seen a year-to-date increase of 16.9%, contrasting with the performance of DBVT's industry [7]