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DBV Technologies Announces Resignation of Board Member
Globenewswire· 2025-09-18 20:30
Core Viewpoint - DBV Technologies announced the resignation of Daniel Soland from its Board of Directors, effective immediately, and expressed gratitude for his contributions since 2015 [1][2]. Company Overview - DBV Technologies is a clinical-stage biopharmaceutical company focused on developing treatment options for food allergies and other immunologic conditions with significant unmet medical needs [3]. - The company is investigating its proprietary VIASKIN® patch technology, which aims to address food allergies through epicutaneous immunotherapy (EPIT) [3]. - The VIASKIN® patch is designed to introduce microgram amounts of biologically active compounds to the immune system via intact skin, aiming to modify the underlying allergy and desensitize the immune system [3]. Current Operations - DBV Technologies is conducting ongoing clinical trials of the VIASKIN Peanut patch for peanut allergic toddlers (ages 1 to 3) and children (ages 4 to 7) [3]. - The company is headquartered in Châtillon, France, with North American operations in Warren, NJ [4]. - The ordinary shares of DBV Technologies are traded on segment B of Euronext Paris, and its American Depositary Shares (ADSs) are traded on the Nasdaq Capital Market [4].
DBV Technologies Establishes an At-The-Market (ATM) Program on Nasdaq
Globenewswire· 2025-09-05 20:30
Core Viewpoint - DBV Technologies has established an At-The-Market (ATM) program to offer up to $150 million of American Depositary Shares (ADS) on Nasdaq, aimed at financing activities related to its Biologics License Application (BLA) and the development of its proprietary technology platform, VIASKIN [1][2]. Group 1: ATM Program Details - The ATM program allows DBV Technologies to sell ADSs representing five ordinary shares, with sales dependent on various market factors [1]. - The program is intended to remain effective until the maximum gross amount is sold or terminated according to the sales agreement with Citizens JMP Securities, LLC [1]. - The previous ATM program established on May 2, 2022, has been terminated, but the new program's terms are similar [1]. Group 2: Use of Proceeds - The net proceeds from the ATM program will primarily be used for activities associated with the BLA, potential approval and launch of the VIASKIN Peanut patch for toddlers aged 1-3, and advancing the development of other product candidates [2]. Group 3: Sales Agreement and Pricing - Citizens JMP Securities will act as the sales agent, using commercially reasonable efforts to sell the ADSs to eligible investors [3]. - The sales price of the new ordinary shares will not be less than the last closing price or the volume-weighted average price over a specified period, with a maximum discount of 15% [3]. Group 4: Share Capital and Dilution - The issuance of new ordinary shares will occur without preferential subscription rights, with a maximum potential dilution of approximately 50% based on existing share capital [4]. - The number of underlying ordinary shares will not exceed the limit set by the shareholders and will represent less than 30% of the ordinary shares already admitted to trading over a rolling 12-month period [4][8]. Group 5: Investor Eligibility - Purchases of ADSs under the ATM program are limited to specific categories of investors, including those regularly investing in the pharmaceutical, biotechnological, or medical technology sectors [6]. Group 6: Trading Information - The new ordinary shares will be admitted to trading on Euronext in Paris, while the issued ADSs will trade on the Nasdaq Capital Market [7]. Group 7: Company Overview - DBV Technologies is a clinical-stage biopharmaceutical company focused on developing treatment options for food allergies using its proprietary VIASKIN patch technology [13]. - The company is headquartered in Châtillon, France, with operations in North America [14].
DBV Technologies to Participate in the H.C. Wainwright 27th Annual Global Investment Conference
Globenewswire· 2025-09-03 20:30
Core Insights - DBV Technologies, a clinical-stage biopharmaceutical company, will participate in the H.C. Wainwright 27 Annual Global Investment Conference on September 9, 2025 [1] - The company is focused on developing treatment options for food allergies using its proprietary VIASKIN patch technology [3] Company Overview - DBV Technologies is headquartered in Châtillon, France, with operations in Warren, NJ, North America [4] - The company is dedicated to addressing significant unmet medical needs related to food allergies through epicutaneous immunotherapy (EPIT) [3] - The VIASKIN patch aims to desensitize individuals to allergens by leveraging the skin's immune properties [3] Clinical Focus - Current clinical trials include the VIASKIN Peanut for peanut allergic toddlers aged 1 to 3 years and children aged 4 to 7 years [3]
DBV Technologies announces filing of 2025 Half-Year Report ― Conditions for accessing or consulting the Report
Globenewswire· 2025-07-29 20:17
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]
DBV Technologies Reports Second Quarter and Half-Year 2025 Financial Results
Globenewswire· 2025-07-29 20:08
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].
DBV Technologies Announces Appointment of James Briggs as Chief Human Resources Officer
Globenewswire· 2025-07-22 20:30
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]
DBV Technologies Announces First Subject Screened in COMFORT Toddlers Supplemental Safety Study in Peanut Allergic Toddlers 1 – 3 Years Old
Globenewswire· 2025-06-25 20:15
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].
DBV Technologies Announces First Subject Screened in COMFORT Toddlers Supplemental Safety Study in Peanut Allergic Toddlers 1 – 3 Years Old
GlobeNewswire News Room· 2025-06-25 20:15
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].