FDA Approval and Product Development - The FDA has agreed that safety exposure data from the VITESSE Phase 3 study is sufficient to support a Biologics License Application (BLA) for the Viaskin peanut patch in children aged 4-7, eliminating the need for the COMFORT Children supplemental safety study[1] - The BLA submission for the Viaskin peanut patch is now expected in the first half of 2026, potentially accelerating the product launch by approximately one year if approved by the FDA[2] - The VITESSE study enrolled 654 participants, making it the largest Phase 3 clinical trial for peanut allergy in this age group, with over 500 participants expected to be included in the safety database at the time of BLA submission[4] - The COMFORT Toddlers study is expected to initiate in the second quarter of 2025, with a BLA submission for the 1-3 year old indication anticipated in the second half of 2026[5] - The company is focused on developing its proprietary VIASKIN® patch technology for food allergies, with ongoing clinical trials for VIASKIN Peanut targeting peanut allergic toddlers and children[26] - DBV Technologies is committed to transforming the care of food allergic individuals through its epicutaneous immunotherapy (EPIT™) approach[26] Financial Performance - Cash and cash equivalents decreased to $32.5 million as of December 31, 2024, from $141.4 million as of December 31, 2023, reflecting a net cash consumption of $108.9 million primarily due to clinical trial-related expenses[10] - Operating income for the year ended December 31, 2024, was $4.2 million, down from $15.7 million in 2023, a decrease of $11.5 million attributed to the termination of a collaboration agreement and lower research tax credits[15] - Operating expenses increased to $120.7 million for the year ended December 31, 2024, compared to $92.2 million in 2023, driven by a $29.1 million rise in research and development costs[17] - The company recorded a net loss of $113.9 million for the year ended December 31, 2024, compared to a net loss of $72.7 million for the same period in 2023, resulting in a net loss per share of $(1.17)[20] - For the year ended December 31, 2024, the net loss was $113.9 million, compared to a net loss of $72.7 million in 2023, representing a 56.7% increase in losses year-over-year[23] - Operating income decreased to $4.2 million in 2024 from $15.7 million in 2023, indicating a decline of 73.3%[23] - Research and Development expenses rose to $89.3 million in 2024, up from $60.2 million in 2023, reflecting a 48.3% increase[23] - Net cash flows used in operating activities were $(104.5) million in 2024, compared to $(79.7) million in 2023, representing a 31.1% increase in cash outflow[24] - The net cash and cash equivalents at the end of the period decreased to $32.5 million in 2024 from $141.4 million in 2023, a decline of 77.0%[24] Capital and Audit Status - The company has incurred operating losses and negative cash flows from operations since inception, with available cash expected to fund operations only into April 2025[11] - The company intends to seek additional capital to support ongoing research and development efforts and the BLA filing for the Viaskin peanut patch[12] - The company has not yet obtained assurance from its auditors that the financial statements will be certified without qualification, indicating ongoing audit procedures[25] Company Overview - DBV Technologies is headquartered in Châtillon, France, with operations in North America located in Warren, NJ[27] - The company's ordinary shares are traded on Euronext Paris and its ADSs on the Nasdaq Capital Market, indicating its presence in both European and U.S. markets[27]

Core Insights - DBV Technologies has secured an agreement with the FDA regarding the safety exposure data required for the Biologics License Application (BLA) for the Viaskin® Peanut Patch in children aged 4 to 7 years, which accelerates the timeline for submission to the first half of 2026 [1][2][5] - The company reported unaudited financial results for the full year 2024, indicating significant cash consumption and operating losses [8][11][23] FDA Agreement and BLA Submission - The FDA has agreed that the safety exposure data from the VITESSE Phase 3 study will be sufficient for the BLA, eliminating the need for the COMFORT Children supplemental safety study [2][5] - The BLA submission is now expected in the first half of 2026, potentially accelerating the product launch by approximately one year, pending FDA approval [2][5][6] - The VITESSE study is the largest Phase 3 clinical trial for peanut allergy in this age group, enrolling 654 participants [3][4] Financial Results - Cash and cash equivalents decreased to $32.5 million as of December 31, 2024, from $141.4 million at the end of 2023, reflecting a net cash consumption of $108.9 million primarily due to clinical trial expenses [11][12] - Operating income for 2024 was $4.2 million, down from $15.7 million in 2023, attributed to the termination of a collaboration agreement and a lower research tax credit [17][23] - The company recorded a net loss of $113.9 million for 2024, compared to a net loss of $72.7 million in 2023, resulting in a net loss per share of $(1.17) [23][24] Research and Development - Operating expenses rose to $120.7 million in 2024, up from $92.2 million in 2023, driven by increased research and development costs related to the ongoing VITESSE trial and preparatory activities for supplemental safety studies [19][21] - The company plans to pursue an Accelerated Approval pathway for the Viaskin peanut patch in toddlers aged 1 to 3 years, with a supplemental safety study expected to begin in Q2 2025 [6][30] Company Overview - DBV Technologies is focused on developing treatment options for food allergies using its proprietary Viaskin® patch technology, which aims to modify allergic reactions through epicutaneous immunotherapy [30][31]

Core Insights - DBV Technologies has secured an agreement with the FDA regarding the safety exposure data required for the Biologics License Application (BLA) for the Viaskin® Peanut Patch in children aged 4 to 7 years, which accelerates the timeline for submission to the first half of 2026 [1][2][5] - The company reported unaudited financial results for the full year 2024, indicating significant cash consumption and operating losses [8][11][12] FDA Agreement and Clinical Trials - The FDA has agreed that the safety data from the VITESSE Phase 3 study will be sufficient for the BLA, eliminating the need for the COMFORT Children supplemental safety study [2][5][6] - The VITESSE study is the largest Phase 3 clinical trial for peanut allergy in this age group, enrolling 654 participants, and is expected to provide robust safety data [3][4][5] - The BLA submission is now anticipated in the first half of 2026, potentially accelerating the product launch by approximately one year, pending FDA approval [2][5][6] Financial Results - Cash and cash equivalents decreased to $32.5 million as of December 31, 2024, from $141.4 million at the end of 2023, reflecting a net cash consumption of $108.9 million primarily due to clinical trial expenses [11][12][15] - Operating income for 2024 was $4.2 million, down from $15.7 million in 2023, attributed to the termination of a collaboration agreement and a lower Research Tax Credit [16][22] - The company recorded a net loss of $113.9 million for 2024, compared to a net loss of $72.7 million in 2023, with a net loss per share of $(1.17) [22][23][26] Research and Development - Operating expenses rose to $120.7 million in 2024, up from $92.2 million in 2023, driven by increased research and development costs related to the ongoing VITESSE trial and preparatory activities for supplemental safety studies [18][21][26] - The company plans to pursue an Accelerated Approval pathway for the Viaskin peanut patch in toddlers aged 1 to 3 years, with a BLA submission expected in the second half of 2026 [6][29]

Core Insights - DBV Technologies will participate in the AAAAI/WAO Joint Congress from February 28 to March 3, 2025, in San Diego, CA, showcasing its research on the VIASKIN® peanut patch [1][5] Group 1: Clinical Study Results - Dr. David Fleischer will present Month 60 efficacy and safety results from the PEOPLE study, which involved peanut-allergic children aged 4-11 years treated with the VIASKIN® peanut patch for up to 60 months [2][9] - The percentage of treatment responders increased from 39.1% at PEPITES completion to 73.3% at Month 60, indicating significant improvement in treatment efficacy over time [7] - Approximately 66.7% of participants achieved an eliciting dose (ED) of 1,000 mg of peanut protein at Month 60, compared to 33.3% at PEPITES completion [7] Group 2: Safety and Compliance - Most treatment-emergent adverse events (TEAEs) were mild to moderate local skin reactions, which decreased in frequency and severity over the study period [7] - Treatment compliance remained high at 93.1% over five years, suggesting strong adherence to the treatment regimen [6][7] Group 3: Future Directions - DBV Technologies is committed to completing studies for regulatory submissions targeting toddlers aged 1-3 years and children aged 4-7 years [8] - The company aims to demonstrate the long-term efficacy and safety of the VIASKIN® peanut patch as a potential breakthrough treatment for peanut allergies [6][11]

Core Viewpoint - DBV Technologies has confirmed alignment with the U.S. FDA on an Accelerated Approval pathway for the Viaskin Peanut patch aimed at toddlers aged 1 to 3 years, with key study design elements agreed upon for the upcoming COMFORT Toddlers study, set to begin in Q2 2025, and a Biologics License Application (BLA) submission anticipated in the second half of 2026 [2][3][17]. Regulatory Pathway - The FDA has issued written communication confirming an Accelerated Approval pathway for the Viaskin Peanut patch, which must meet three qualifying criteria: treatment of a serious condition, meaningful advantage over existing therapies, and demonstration of an effect likely to predict clinical benefit [4]. - DBV has received confirmation that the Viaskin Peanut patch meets the first two criteria and that the efficacy data from the Phase 3 EPITOPE study can serve as an intermediate clinical endpoint for the third criterion [5][4]. Study Design and Execution - The COMFORT Toddlers study will be a Phase 3 double-blind, placebo-controlled study designed to generate additional safety and adhesion data for the Viaskin Peanut patch in peanut-allergic toddlers [13]. - The study is expected to enroll approximately 480 subjects across 80-90 study centers in the U.S., Canada, Australia, and Europe, with a six-month study duration followed by an optional 18-month open-label treatment phase [14][13]. Product Development - DBV has made modifications to the Viaskin Peanut patch to enhance caregiver application simplicity and product identification, while maintaining the same device components in contact with the patient's skin [6]. - The commercial Viaskin Peanut patch has been used in 304 subjects with over 234,695 patient-days of therapy, showing no clinically relevant differences in efficacy or safety compared to the clinical patch used in the EPITOPE study [10]. Post-Marketing Study - The FDA has confirmed criteria for a post-marketing confirmatory study, which will assess the effectiveness of the intended commercial Viaskin Peanut patch and must be initiated at the time of BLA submission [9]. - The confirmatory study will include a double-blind, placebo-controlled food challenge and will use the same statistical criteria for success as the EPITOPE Phase 3 efficacy study [11]. Company Overview - DBV Technologies is a clinical-stage biopharmaceutical company focused on developing treatment options for food allergies through its proprietary Viaskin patch technology, which aims to modify allergic reactions by re-educating the immune system [19]. - The company is headquartered in Châtillon, France, with North American operations in Warren, NJ, and its shares are traded on Euronext Paris and the Nasdaq Capital Market [20].

Financial Position - DBV's cash and cash equivalents amount to $46.4 million as of September 30, 2024, down from $66.2 million as of June 30, 2024, reflecting a net decrease of $19.8 million[12]. - The company has incurred operating losses and negative cash flows from operations since inception, raising substantial doubt regarding its ability to continue as a going concern[14]. - The company plans to seek additional capital to support its operations and research and development efforts into Q1 2025[14]. Clinical Trials and Studies - The company expects to enroll approximately 300 - 350 subjects in the COMFORT Toddlers safety study, bringing the total safety database for the Viaskin Peanut patch in toddlers to approximately 600 subjects[4]. - A total of 654 subjects were enrolled in the VITESSE Phase 3 efficacy trial for children ages 4 – 7 years-old, with topline data anticipated in the fourth quarter of 2025[9]. - DBV plans to initiate the COMFORT Children safety study in the second quarter of 2025, aiming to enroll approximately 250 subjects to reach a total of about 600 subjects in the development program for 4 – 7 year-olds[9]. - The COMFORT Toddlers safety study is expected to be initiated in Q2 2025, with a focus on patch adhesion and wear time data collection[4]. Regulatory and Approval Processes - DBV intends to submit a meeting request to formalize the Accelerated Approval guidance provided by the FDA for the Viaskin Peanut patch in toddlers ages 1 – 3 years-old[3]. - The EMA confirmed that the completed EPITOPE study in 1 – 3 year-olds and a positive VITESSE study in 4 – 7 year-olds could support a Marketing Authorization Application for a 1 – 7 year-old indication[10]. - DBV's proposed labeling solution submitted to the FDA aims to link adhesion, efficacy, and safety to inform the product label[8].

Financial Performance - Operating income for the three months ended September 30, 2024, was €1,072,000, down from €2,372,000 for the same period in 2023, representing a decrease of approximately 54.8%[11] - Net loss for the nine months ended September 30, 2024, was €90,903,000, compared to a net loss of €61,540,000 for the same period in 2023, reflecting an increase in loss of approximately 47.6%[13] - Total comprehensive loss for the nine months ended September 30, 2024, was €91,138,000, compared to €62,111,000 for the same period in 2023, an increase of approximately 46.9%[11] - Basic/diluted net loss per share attributable to shareholders for the three months ended September 30, 2024, was €0.32, compared to €0.17 for the same period in 2023, indicating a worsening of 88.2%[11] - Net loss for Q3 2024 was $30,442 million, an increase of 81.9% from a net loss of $16,736 million in Q3 2023[77] - Net loss increased to $90.9 million for the nine months ended September 30, 2024, compared to a net loss of $61.5 million for the same period in 2023, resulting in a net loss per share of $0.95[98] Assets and Liabilities - Total current assets decreased from €158,915,000 on December 31, 2023, to €68,759,000 on September 30, 2024, a decline of approximately 56.7%[7] - Total liabilities decreased from €42,799,000 on December 31, 2023, to €39,021,000 on September 30, 2024, a reduction of about 8.5%[8] - Total shareholders' equity dropped from €140,187,000 on December 31, 2023, to €54,034,000 on September 30, 2024, a decrease of approximately 61.5%[9] - Cash and cash equivalents decreased significantly from €141,367,000 at the beginning of the period to €46,441,000 at the end of the period, a decline of about 67.1%[13] - The company reported a total shareholders' equity of $54.034 million, down from $79.095 million as of June 30, 2024, reflecting a net loss of $30.442 million for the quarter[16] Research and Development - Research and development expenses increased to €23,662,000 for the three months ended September 30, 2024, compared to €13,795,000 for the same period in 2023, an increase of about 71.5%[11] - The company is preparing for the potential launch of its first product, Viaskin Peanut, in the U.S. and EU, pending regulatory approval[21] - The company initiated the VITESSE Phase 3 pivotal study for the modified Viaskin Peanut patch in children aged 4-7 years, with topline results anticipated by the fourth quarter of 2025[25] - The Company plans to enroll approximately 300-350 subjects in the COMFORT Toddlers safety study, bringing the total safety database for the Viaskin Peanut patch in toddlers to approximately 600 subjects[37] - The Company submitted the protocol for the COMFORT Children supplemental safety study for ages 4-7 years to the FDA, expecting to enroll around 250 subjects, raising the total to approximately 600 in this age group[30] Cash Flow and Financing - The company reported a net cash flow used in operating activities of €92,222,000 for the nine months ended September 30, 2024, compared to €65,967,000 for the same period in 2023, reflecting an increase in cash outflow of about 39.8%[13] - The company plans to seek additional capital to support its research and development efforts and the launch of Viaskin Peanut, which may involve debt and equity offerings[21] - The company has established an At-The-Market program to raise up to $100 million through the sale of American Depositary Shares[101] - The net cash flow from financing activities decreased to $(0.1) million for the nine months ended September 30, 2024, compared to $7.0 million in the same period of 2023[109] Regulatory and Compliance - The company received a Complete Response Letter from the FDA in August 2020 regarding the Viaskin Peanut BLA, necessitating patch modifications and additional clinical data[25] - The Company announced positive regulatory updates for the Viaskin Peanut patch in the U.S. and Europe, with guidance from the FDA on a potential pathway under the Accelerated Approval Program for toddlers aged 1-3 years[35] - The Company has been engaged in ongoing dialogue with the FDA regarding the COMFORT Toddlers supplemental safety study for children aged 1-3 years with peanut allergies[26] - The Company intends to resubmit the Marketing Authorization Application (MAA) for Viaskin Peanut once the necessary data set is available[32] Operational Expenses - Total operating expenses increased by 52.1% to $31,401 million in Q3 2024 from $20,642 million in Q3 2023[77] - Total operating expenses for the nine months ended September 30, 2024, were $96.37 million, an increase of 35.0% compared to $71.37 million in 2023[88] - General and administrative expenses increased by $1.04 million to $7.22 million for the three months ended September 30, 2024, a 16.8% increase from $6.18 million in 2023[83] - Personnel expenses increased to $8,331 million in Q3 2024 from $6,724 million in Q3 2023, a rise of 24%[63] Other Financial Metrics - The estimated research tax credit for the first nine months of the 2024 fiscal year amounts to $3,640 thousand, compared to $4,978 thousand for the same period in 2023[61] - Research tax credit decreased by $1.34 million to $3.64 million for the nine months ended September 30, 2024, a 26.9% decrease from $4.98 million in 2023[89] - Financial income decreased to $1.9 million for the nine months ended September 30, 2024, down from $3.0 million in the same period of 2023[96] Management and Governance - The report was signed by Daniel Tassé, Chief Executive Officer, and Virginie Boucinha, Chief Financial Officer, on November 6, 2024[124]

Core Insights - DBV Technologies reported a cash balance of $46.4 million as of September 30, 2024, down from $141.4 million at the end of 2023, indicating a net decrease of $95.0 million primarily due to operating activities related to clinical trials [3][4][5] - The company has incurred operating losses and negative cash flows since inception, raising substantial doubt about its ability to continue as a going concern without additional capital [4][6] - DBV expects its cash reserves to last into Q1 2025, but it plans to seek additional financing to support ongoing research and development efforts [5][6] Financial Performance - For the nine months ended September 30, 2024, DBV reported an operating income of $3.6 million, a decrease from $6.9 million in the same period of 2023, attributed to the termination of a collaboration agreement and lower research tax credits [11][12] - Operating expenses increased to $96.4 million for the nine months ended September 30, 2024, compared to $71.4 million in the same period of 2023, driven mainly by research and development costs [12][13] - The net loss for the nine months ended September 30, 2024, was $90.9 million, compared to a net loss of $61.5 million for the same period in 2023, with a net loss per share of $(0.95) [14][16] Cash Flow Analysis - The net cash flow used in operating activities was $(92.2) million for the nine months ended September 30, 2024, compared to $(66.0) million for the same period in 2023 [17] - Cash and cash equivalents decreased by $94.9 million during the nine months ended September 30, 2024, reflecting significant cash outflows [17] Company Overview - DBV Technologies is focused on developing treatment options for food allergies using its proprietary Viaskin technology platform, which aims to modify immune responses through epicutaneous immunotherapy [18] - The company is currently conducting clinical trials for its Viaskin Peanut product aimed at peanut allergies in young children [18][19]

Core Insights - DBV Technologies announced positive regulatory updates for the Viaskin Peanut patch in the U.S. and Europe, including an Accelerated Approval pathway for toddlers aged 1-3 years [1][2][9] - The company plans to initiate a six-month supplemental safety study in toddlers in Q2 2025, which is a prerequisite for the Biologics License Application (BLA) submission [1][4] - The VITESSE Phase 3 study for children aged 4-7 years exceeded enrollment goals, with topline results expected in Q4 2025 [1][8] Regulatory Developments - DBV has received FDA guidance confirming that the Viaskin Peanut patch meets the criteria for Accelerated Approval, addressing a serious condition with meaningful advantages over existing therapies [2][3] - The European Medicines Agency (EMA) has provided scientific advice confirming a registration path for a Marketing Authorization Application (MAA) for the modified patch for ages 1-7 [1][9] Clinical Studies - The COMFORT Toddlers safety study will enroll approximately 300-350 subjects, aiming to build a safety database of around 600 subjects for toddlers [4] - The VITESSE study for children aged 4-7 years enrolled 654 subjects, with plans for a safety study to begin in Q2 2025 [8] Financial Overview - As of September 30, 2024, DBV reported cash and cash equivalents of $46.4 million, down from $66.2 million as of June 30, 2024, primarily due to operating expenses [11] - The company anticipates that its cash reserves will support operations into Q1 2025, with plans to seek additional capital for ongoing research and development [13] Investor Engagement - DBV management will host an investor conference call to discuss these regulatory updates, scheduled for October 22, 2024, at 5:00 PM ET [14]

Core Insights - DBV Technologies will participate in the ACAAI Annual Scientific Meeting from October 24 to 28, 2024, in Boston, focusing on peanut allergy treatment [1][2] - The company has completed enrollment for its VITESSE trial in children aged 4 to 7 years, highlighting its commitment to addressing unmet medical needs in food allergies [3][5] - DBV's lead product, the Viaskin® Peanut patch, aims to reduce allergic reactions to peanuts through a non-invasive epicutaneous delivery system [4][5] Company Activities - DBV is sponsoring the 33rd Annual FIT Bowl, a competition testing knowledge in allergy, asthma, and immunology, scheduled for October 26, 2024 [2] - The company will host a booth at the ACAAI Exhibit Hall from October 25 to 28, 2024, to engage with attendees [2] - DBV is a Benefactor Level Corporate Council Member for the 2024 ACAAI [2] Product Information - The Viaskin® Peanut patch is designed to deliver microgram quantities of peanut antigen to re-educate the immune system, although its safety and efficacy have not yet been established by regulatory agencies [4][5] - The patch represents a new class of treatment known as epicutaneous immunotherapy (EPIT™), which aims to modify allergic responses through the skin [5][6] Clinical Trials - DBV is conducting ongoing clinical trials for the Viaskin Peanut patch in toddlers aged 1 to 3 years and children aged 4 to 7 years [5][6] - The company emphasizes the importance of addressing the significant unmet medical need in food allergies, particularly for young children [3][5]