Summary of DBV Technologies Conference Call Company Overview - **Company**: DBV Technologies (NasdaqCM:DBVT) - **Focus**: Immunology, specifically food allergies in children - **Lead Product**: Viaskin Peanut, aimed at treating peanut allergies in children aged 1-7 Key Points Product Development and Regulatory Filings - **BLA Filings**: Two Biologics License Applications (BLAs) are planned for 2026: - **Children aged 4-7**: Expected filing by mid-2026 - **Children aged 1-3**: Expected filing by the end of 2026 - **FDA Designation**: The product has received breakthrough designation from the FDA and will seek priority review for the first filing [1][2][3] Market Opportunity - **Prevalence of Food Allergies**: Approximately 670,000 children in the U.S. have diagnosed peanut allergies: - 390,000 children aged 4-7 - 280,000 children aged 1-3 - **Response Rates**: In the 1-3 age group, the response rate was 67% for active treatment compared to 33.5% for placebo, with a 22.4% delta [24][25] Clinical Trial Insights - **VITESSE Trial**: The largest trial for peanut allergy with 654 patients, showing a placebo-adjusted efficacy of 32 points [13][14] - **Long-term Benefits**: Open-label extensions indicate improved efficacy and safety over time, with 68% of children in the 1-3 age group able to consume significant amounts of peanuts without anaphylaxis after three years of treatment [25][26] Competitive Landscape - **Comparison with IgE Blockade**: DBV Technologies focuses on desensitization, which is seen as disease-modifying, while IgE blockade is viewed as a temporary solution [5][7][58] - **Palforzia Comparison**: DBV believes Viaskin Peanut is superior due to its ease of use and lower risk of anaphylaxis compared to Palforzia, which requires frequent physician visits and has a higher rate of anaphylaxis during treatment [63][64] Commercial Strategy - **Target Audience**: Approximately 4,500 allergists and immunologists in the U.S. will be targeted for prescribing [43] - **Sales Force**: Estimated need for 50-70 sales representatives to reach the target audience effectively [46] - **Pricing Strategy**: While no final price has been set, Palforzia's pricing at around $1,000 per month is considered a reference point [47][48] Future Directions - **Expansion Plans**: After the approval of Viaskin Peanut, the company plans to pursue other allergies, with cow's milk allergy as the next target [82] - **Manufacturing Capacity**: Current manufacturing is sufficient for initial launch, but plans to triple capacity in the coming years are in place [83] Financial Position - **Funding**: As of Q3, the company has $320 million, which is deemed sufficient to support the launch in 2027 and necessary investments [88][91] Additional Insights - **Engagement with Families**: The company emphasizes the importance of communication with families and patient advocacy groups, as parents of children with food allergies are highly engaged [46] - **Safety Profile**: The Viaskin Peanut patch has shown no severe adverse events in clinical studies, which may lead to a cleaner label compared to other treatments [74][75] This summary encapsulates the critical aspects of DBV Technologies' conference call, highlighting the company's strategic direction, product development, market potential, and competitive positioning in the food allergy treatment landscape.

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]

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].

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 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 Points - DBV Technologies will hold its Combined General Meeting on June 11, 2025, at 02:00 p.m. CEST at its headquarters in Châtillon, France [1] - The preliminary notice with the detailed agenda and instructions for participation was published on May 07, 2025 [2] - Shareholders can access preparatory documents on the Company's website, in compliance with legal provisions [3] - Shareholders wishing to receive documents by post or electronically must request them by June 06, 2025 [4] - A live webcast of the General Meeting will be available on the Company's website, with a recorded version accessible for at least the minimum legal period [5] Company Overview - DBV Technologies is a clinical-stage biopharmaceutical company focused on developing treatments for food allergies and other immunologic conditions [6] - The Company utilizes its proprietary Viaskin technology platform to address food allergies through epicutaneous immunotherapy (EPIT™) [6] - DBV Technologies is conducting clinical trials for Viaskin Peanut in peanut allergic toddlers and children [6] - The Company is headquartered in Châtillon, France, with operations in Warren, NJ, and its shares are traded on Euronext Paris and Nasdaq [7]

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 [6] - The company is investigating the use of its proprietary technology platform, Viaskin, to address food allergies through epicutaneous immunotherapy (EPIT™) [6] - DBV Technologies is committed to transforming the care of individuals with food allergies, with ongoing clinical trials for Viaskin Peanut targeting peanut allergic toddlers and children [6] Upcoming General Meeting - The Combined General Meeting is scheduled for June 11, 2025, at 02:00 p.m. CEST at the company's headquarters in Châtillon, France [1] - A preliminary notice containing the detailed agenda and draft resolutions was published on May 07, 2025, and the official meeting notice will be published on May 21, 2025 [2] - Shareholders can access preparatory documents on the company's website, and requests for documents can be made until June 06, 2025 [3][4] Webcast Information - A live webcast of the General Meeting will be available on the company's website, with a recorded version accessible within seven business days after the meeting [5]