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]

Core Insights - DBV Technologies will participate in the ACAAI 2025 Annual Scientific Meeting from November 6 to 10 in Orlando, Florida [1] - The company will host a Product Theater discussing the benefits of early intervention in food allergy management [2][3] - A planned Phase 2 clinical study will assess the efficacy and safety of the VIASKIN® Peanut patch for peanut-allergic infants aged 6 to 12 months [2][4] Product Theater Details - Dr. Gideon Lack will lead discussions on proactive food allergy management and the potential of the VIASKIN® Peanut patch [3] - The study aims to determine if earlier intervention can facilitate ad lib peanut consumption in young children [3] - Dr. Matthew Greenhawt will present end-of-study results from the EPITOPE study during the meeting [3][8] Company Commitment - DBV Technologies emphasizes its commitment to the younger patient population in the food allergy community [4] - The company anticipates a potential BLA filing for the VIASKIN® Peanut patch for toddlers aged 1 to 3 years in the second half of next year [4] - DBV is focused on developing treatment options for food allergies using its proprietary VIASKIN® patch technology [9] Event Participation - DBV will exhibit at booth 711 and sponsor the 34th Annual FIT Bowl™, a competition testing knowledge in allergy, asthma, and immunology [6] - The competition is scheduled for November 8, 2025 [6] Company Overview - DBV Technologies is a clinical-stage biopharmaceutical company headquartered in Châtillon, France, with operations in North America [10] - The company is dedicated to transforming the care of individuals with food allergies through innovative therapies [9]

Financial Performance - 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, representing an increase of 12.9%[7] - Operating expenses increased 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] - The company recorded operating income of $5.0 million for the nine months ended September 30, 2025, compared to $3.6 million for the same period in 2024, reflecting a growth of 38.9%[4] - Research tax credits increased to $5.0 million for the nine months ended September 30, 2025, compared to $3.6 million in 2024, indicating a rise of 38.9%[4] - Net cash flows used in operating activities decreased to $86.0 million for the nine months ended September 30, 2025, from $92.2 million in the same period of 2024, a reduction of 6.7%[18] Cash Position and Financing - Cash and cash equivalents rose to $69.8 million as of September 30, 2025, compared to $32.5 million at the end of 2024, marking a net increase of $37.4 million[9] - The company anticipates that its cash and cash equivalents will be sufficient to fund operations into the third quarter of 2026, based on current plans and assumptions[14] - An equity offering program was established in September 2025, allowing the company to offer American Depositary Shares with an aggregate offering price of up to $150.0 million[13] - The company expects to utilize proceeds from a private placement financing of up to $306.9 million to advance the Viaskin® Peanut patch through Biologics License Application submission and U.S. commercial launch, if approved[10] Future Prospects - The VITESSE Phase 3 study's primary endpoint achievement will trigger an acceleration of warrant exercises, potentially providing up to $181.4 million in gross proceeds[12]

Financial Performance - Total assets increased to $110.495 million as of September 30, 2025, up from $65.658 million at December 31, 2024, representing a 68% growth[16] - Operating income for the three months ended September 30, 2025, was $2.774 million, compared to $1.072 million for the same period in 2024, reflecting a 159% increase[20] - Net loss for the nine months ended September 30, 2025, was $102.118 million, compared to a net loss of $90.903 million for the same period in 2024, indicating a 12% increase in losses[22] - Comprehensive loss for the nine months ended September 30, 2025, was $95.106 million, compared to $91.138 million for the same period in 2024, indicating a 4% increase[20] - The company reported a basic/diluted net loss per share of $0.24 for the three months ended September 30, 2025, compared to $0.32 for the same period in 2024[20] - The company reported a comprehensive loss of $34.003 million for the three months ended September 30, 2025, compared to $26.658 million in 2024, indicating a 28% increase in comprehensive losses[20] - Net cash flow used in operating activities for the nine months ended September 30, 2025, was $(86.008 million), a slight improvement from $(92.222 million) in 2024[21] Liquidity and Capital Resources - Cash and cash equivalents at the end of the period were $69.837 million, up from $32.456 million at the beginning of the period, showing a significant increase in liquidity[22] - The company raised $116.936 million through capital increases during the nine months ended September 30, 2025, significantly enhancing its financial position[22] - The company expects to receive up to $181.4 million in gross proceeds if all warrants are exercised, contingent on the VITESSE Phase 3 study hitting its primary endpoint[43] - The company anticipates that its cash and cash equivalents will fund operations into the third quarter of 2026[44] - The company is actively pursuing additional financing options, including sales under the ATM program and potential warrant exercises[45] - The financing announced on March 27, 2025, amounts to up to $306.9 million, including gross proceeds of $125.5 million received on April 7, 2025, to support the Viaskin Peanut patch development and potential U.S. commercial launch[85] - The financing resulted in an immediate dilution of 22.4% and a maximal dilution of up to 73.7% of existing shareholders if all warrants are exercised[86] Research and Development - Research and development expenses rose to $28.615 million for the three months ended September 30, 2025, compared to $23.662 million in 2024, marking a 21% increase[20] - The Company plans to submit a Biologics License Application (BLA) for the Viaskin Peanut patch in children aged 4-7 years in the first half of 2026, potentially accelerating the product launch by approximately one year[84] - The Company anticipates enrolling approximately 300-350 subjects in the COMFORT Toddlers supplemental safety study, bringing the total safety database to around 600 subjects[79] - The Company announced positive topline results from the EPITOPE phase 3 study, demonstrating statistical superiority in desensitizing children to peanut exposure[74] - The Company received feedback from the FDA in October 2023 regarding the remaining protocol design elements for the COMFORT Children study[83] - The Company will utilize safety data from the VITESSE study for the BLA filing in the 4-7 age group, eliminating the need for the COMFORT Children supplemental safety study[84] Regulatory and Compliance - The company anticipates re-submitting a Biologics License Application for the Viaskin Peanut patch to the FDA, with expectations for an Accelerated Approval pathway for toddlers aged 1-3 years[14] - The FDA confirmed that the Company met Accelerated Approval qualifying criteria 1 and 2 for the Viaskin Peanut patch in toddlers aged 1-3[78] - The Company received a Complete Response Letter from the FDA in August 2020 regarding the Viaskin Peanut patch, indicating it could not approve the BLA in its then-current form[54] - The Company withdrew its MAA for the Viaskin Peanut patch in December 2021 due to outstanding issues identified by the EMA[67] - The Company reached alignment with the FDA on the Accelerated Approval pathway for the Viaskin Peanut patch in toddlers aged 1-3 years, confirming key study design elements for the COMFORT Toddlers study[80] Personnel and Operations - The average number of employees increased to 117 as of September 30, 2025, from 108 in the same period of 2024[115] - Total personnel expenses for the nine months ended September 30, 2025, are $25,342 million, slightly down from $25,774 million in 2024[115] - The Company has not been subject to any material legal proceedings as of the current date[95] Accounting and Financial Reporting - The Company adopted ASU 2023-07 for reportable segment disclosures starting in Q4 FY 2024, enhancing disclosures on significant segment expenses[48] - The Company is currently evaluating the impact of ASU 2023-09 on its consolidated financial statements, which enhances income tax disclosures[50] - The Company plans to adopt new accounting standards that may enhance the transparency of its financial disclosures starting in fiscal year 2025[50][51]

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]

Core Insights - DBV Technologies S.A. (DBVT) shares increased by 6.8% in the last trading session, closing at $17, with notable trading volume compared to typical sessions, and a total gain of 61.3% over the past four weeks [1][2] Company Performance - The price surge is linked to growing investor optimism regarding the company's Viaskin technology platform aimed at treating food allergies, with ongoing studies for peanut allergies in toddlers and young children [2] - The company is projected to report a quarterly loss of $1.45 per share, reflecting an 81.3% year-over-year decline, while revenues are expected to reach $1.48 million, marking a 38.3% increase from the previous year [3] - The consensus EPS estimate for the upcoming quarter has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] Industry Context - DBV Technologies is part of the Zacks Medical - Biomedical and Genetics industry, where another company, Ultragenyx (RARE), saw a 1.6% increase in its stock price, closing at $33.97, with a 16.4% return over the past month [5] - Ultragenyx's consensus EPS estimate has decreased by 0.4% over the past month to -$1.23, which represents a 12.1% increase compared to the previous year's EPS [6]

Group 1 - U.S. stock futures are lower, with Dow futures falling more than 350 points [1] - Orion SA expects third-quarter adjusted EBITDA to be around $55 million and full-year adjusted EBITDA in the range of $220-$235 million, leading to an 18.6% drop in shares to $5.56 in pre-market trading [1] Group 2 - ENDRA Life Sciences Inc shares fell 19.4% to $6.54 after a previous 25% increase due to $4.9 million in funding commitments [4] - Canaan Inc shares tumbled 11.8% to $1.34 after a 39% jump, despite a maintained Buy rating and $4 price target from Rosenblatt analyst [4] - DBV Technologies SA shares fell 11.8% to $14.48 after gaining around 10% previously [4] - Nanobiotix SA shares tumbled 10.2% to $27.23 after a previous increase of over 28% [4] - Draganfly Inc shares dipped 9.4% to $12.47 after filing for a mixed shelf of up to $200 million [4] - Bitdeer Technologies Group shares fell 9% to $18.61 after a 15% gain [4] - Diginex Ltd shares fell 9% to $23.40 [4] - HIVE Digital Technologies shares dipped 8.1% to $6.21, despite a maintained Buy rating and $10 price target [4] - Oatly Group AB shares fell 7.8% to $13.29 after a 5% gain [4] - Bit Digital Inc shares declined 7.7% to $3.69 after a previous gain of over 6% [4] - Upexi Inc shares fell 7.7% to $5.98 [4] - Sharplink Gaming Inc shares declined 7.1% to $14.98 after adding 5% previously [4] - Nio Inc shares fell 5% to $6.82, influenced by new port fees affecting US-listed Chinese stocks [4] - Alibaba Group Holding Ltd shares declined 4% to $160.20, also impacted by new port fees [4]

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].

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].

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].