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DBV Technologies Announces Last Patient Visit Completed in VITESSE Phase 3 Clinical Trial of VIASKIN® Peanut Patch in Peanut Allergic Children Aged 4-7 Years
Globenewswire· 2025-11-12 04:50
Core Insights - DBV Technologies has completed the last patient visit in the Phase 3 VITESSE clinical trial for the VIASKIN Peanut patch aimed at peanut allergic children aged 4-7 years, with topline data expected in Q4 of this year [1][2][3] 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 [4] - The company aims to address food allergies through epicutaneous immunotherapy (EPIT), which introduces microgram amounts of biologically active compounds to the immune system via intact skin [4] Clinical Trial Details - The VITESSE Phase 3 trial involves 654 subjects aged 4-7 years, randomized in a 2:1 ratio, and is conducted across 86 sites in the U.S., Canada, Europe, the UK, and Australia, making it the largest treatment intervention study for peanut allergy [3] - The trial evaluates the efficacy and safety of the VIASKIN Peanut patch over a 12-month period [3] Future Outlook - The completion of the last patient visit is considered a significant milestone for the company, moving closer to potentially providing a treatment option for peanut allergic children if approved [3]
DBV Technologies Appoints Industry Leader Kevin Trapp as Chief Commercial Officer
Globenewswire· 2025-11-03 21:30
Core Insights - DBV Technologies has appointed Kevin Trapp as Chief Commercial Officer to lead global commercial strategy for the Viaskin® Peanut patch [1][2] - The company plans to submit a Biologics License Application (BLA) for children aged 4-7 with peanut allergies in the first half of 2026, followed by a submission for 1-3 year-olds in the second half of the same year [1][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® patch technology to address food allergies through epicutaneous immunotherapy (EPIT), which aims to desensitize the immune system to allergens [4] Leadership Background - Kevin Trapp has over 30 years of experience in the biopharmaceutical industry and has been involved with DBV's commercial strategy since 2017 [2][3] - Prior to rejoining DBV, Trapp served as Managing Director at Biotech Value Advisors, advising biotechnology companies on product strategy and launch planning [2][3] Product Development - The Viaskin Peanut patch aims to provide a new treatment option for families living with food allergies, addressing an urgent medical need [3][4] - DBV Technologies is currently conducting clinical trials for the VIASKIN Peanut patch in toddlers and children with peanut allergies [4]
DBV Technologies Announces Appointment of Philina Lee, Ph.D. to Board of Directors
Globenewswire· 2025-10-30 20:30
Core Points - DBV Technologies has appointed Dr. Philina Lee as an independent director to its Board of Directors, effective October 30, 2025, replacing Daniel Soland, pending shareholder ratification [1][2] - Dr. Lee brings extensive experience in the biopharmaceutical sector, having previously served as Chief Commercial Officer at Blueprint Medicines, where she led the successful launch of AYVAKIT® [2] - The company is focused on advancing its proprietary VIASKIN® Peanut patch technology for treating peanut allergies in children and toddlers, with ongoing clinical trials [3][4] Company Overview - DBV Technologies is a clinical-stage biopharmaceutical company headquartered in Châtillon, France, with operations in Warren, NJ, specializing in treatments for food allergies and other immunologic conditions [4] - The company is committed to transforming care for individuals with food allergies through its epicutaneous immunotherapy (EPIT) approach, which aims to desensitize the immune system to allergens [3]
DBV Technologies Reports Third Quarter 2025 Financial Results
Globenewswire· 2025-10-28 20:25
Core Insights - DBV Technologies reported a net loss of $102.1 million for the nine months ended September 30, 2025, compared to a net loss of $90.9 million for the same period in 2024, with a net loss per share of $0.82 [7][8][25] - The company ended Q3 2025 with cash and cash equivalents of $69.8 million, a significant increase from $32.5 million at the end of 2024, providing a cash runway into the third quarter of 2026 [9][13] - Operating expenses rose to $107.0 million for the nine months ended September 30, 2025, up from $96.4 million in the same period of 2024, primarily due to the launch of the COMFORT Toddlers supplemental safety study [5][6] Financial Highlights - Research tax credits increased to $5.0 million for the nine months ended September 30, 2025, compared to $3.6 million in 2024, reflecting more eligible activities [4] - Operating income for the nine months ended September 30, 2025, was $5.0 million, up from $3.6 million in 2024 [4] - Total liabilities increased to $57.6 million as of September 30, 2025, from $38.3 million at the end of 2024 [23] Cash Flow and Financing - Net cash flow used in operating activities decreased to $86.0 million for the nine months ended September 30, 2025, from $92.2 million in 2024, indicating improved cost management [20] - The company raised $117.1 million from financing activities during the nine months ended September 30, 2025, compared to a negligible amount in the same period of 2024 [22] - DBV Technologies established an equity offering program with an aggregate offering price of up to $150.0 million, and subsequently raised approximately $30 million from the issuance of shares [12] Business Overview - DBV Technologies focuses on developing treatment options for food allergies using its proprietary VIASKIN® patch technology, which aims to modify the immune response to allergens [26] - The company is currently conducting clinical trials for the VIASKIN Peanut patch in young children with peanut allergies [26] - DBV Technologies is headquartered in Châtillon, France, with operations in North America [27]
DBV Technologies Announces Sale of approximately $30 million of ADSs Through its At-The-Market (ATM) Program on Nasdaq
Globenewswire· 2025-10-06 21:02
Core Viewpoint - DBV Technologies has announced the sale of approximately $30 million of American Depositary Shares (ADSs) through its At-The-Market (ATM) program on Nasdaq, aimed at raising funds for its clinical-stage biopharmaceutical operations [1][2]. Group 1: Financial Details - The company will issue 11,538,460 new Ordinary Shares, equivalent to 2,307,692 new ADSs, at an at-the-market price of $13.00 per ADS, resulting in gross proceeds of approximately $30 million before expenses [2]. - The issuance price per Ordinary Share is €2.2264, based on the USD/EUR exchange rate of $1.1678 for €1, reflecting a discount of 3.41% to the last closing price on Euronext Paris [2]. - The new Ordinary Shares will represent 8.42% of the existing shares on Euronext Paris, with a dilution effect of approximately 7.77% upon completion of the transaction [3][4]. Group 2: Regulatory and Market Information - The new ADSs will be admitted to trading on Nasdaq, while the new Ordinary Shares will be listed on Euronext Paris [3]. - The share capital increase is exempt from the requirement of a prospectus approval by the French Financial Markets Authority, as it is offered to qualified investors and represents less than 30% of the existing shares over a rolling 12-month period [6][12]. Group 3: Company Overview - DBV Technologies is a clinical-stage biopharmaceutical company focused on developing treatments for food allergies and other immunologic conditions, utilizing its proprietary Viaskin technology platform [12][13]. - The company is currently conducting clinical trials for its Viaskin Peanut product aimed at treating peanut allergies in young children [12].
DBV Technologies Announces Sale of approximately $30 million of ADSs Through its At-The-Market (ATM) Program on Nasdaq
Globenewswire· 2025-10-06 21:02
Core Viewpoint - DBV Technologies has announced the sale of approximately $30 million of American Depositary Shares (ADSs) through its At-The-Market (ATM) program on Nasdaq, which will involve the issuance of new ordinary shares [1][2]. Group 1: Financial Details - The ATM program will issue 11,538,460 new ordinary shares, equivalent to 2,307,692 new ADSs, at an at-the-market price of $13.00 per ADS, resulting in gross proceeds of approximately $30 million before expenses [2]. - The issuance price per ordinary share is €2.2264, based on the USD/EUR exchange rate of $1.1678 for €1, reflecting a discount of 3.41% to the last closing price of the company's shares on Euronext Paris [2]. - The new ordinary shares will represent 8.42% of the existing shares on Euronext Paris, with a dilution of approximately 7.77% upon completion of the transaction [3][4]. Group 2: Regulatory and Market Information - The new ordinary shares will be admitted to trading on Nasdaq and Euronext Paris, with the issuance expected to take place on October 8, 2025 [3]. - A shelf registration statement on Form S-3 relating to the ADSs has been filed with the SEC and declared effective, allowing for the offering without the need for a prospectus approval from the French Financial Markets Authority [5][6]. - The share capital structure before and after the ATM issuance shows a change in ownership percentages among major shareholders, with Invus increasing its stake significantly [7][8]. Group 3: Company Overview - DBV Technologies is a clinical-stage biopharmaceutical company focused on developing treatments for food allergies and other immunologic conditions, utilizing its proprietary Viaskin technology platform [12]. - The company is currently conducting clinical trials for its Viaskin Peanut product aimed at treating peanut allergies in young children [12][13].
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
Châtillon, France, September 3, 2025 DBV Technologies to Participate in the H.C. Wainwright 27th Annual Global Investment Conference DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT – CUSIP: 23306J309), a clinical-stage biopharmaceutical company, today announced that Daniel Tassé, Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright 27th Annual Global Investment Conference on Tuesday, September 9, 2025, at 11:30am ET, in New York, NY. A live web ...
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]