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]

Core Insights - DBV Technologies has successfully completed the patient screening for the VITESSE Phase 3 clinical trial, which evaluates the Viaskin® Peanut Patch in children aged 4 to 7 with peanut allergies [1][2] - The VITESSE trial is the largest immunotherapy clinical trial for this demographic, involving over 600 subjects across 86 sites in multiple countries [2] - Topline results from the VITESSE study are anticipated by Q4 2025 [1] Company Overview - DBV Technologies is a clinical-stage biopharmaceutical company focused on developing treatments for food allergies and other immunologic conditions [3] - The company utilizes its proprietary Viaskin technology platform to address food allergies through epicutaneous immunotherapy (EPIT™), which aims to desensitize the immune system to allergens [3] - DBV is committed to transforming the care of individuals with food allergies, with ongoing clinical trials for Viaskin Peanut targeting both toddlers and children [3] Operational Highlights - The VITESSE Phase 3 trial is a 12-month study designed to evaluate the efficacy and safety of the Viaskin Peanut Patch [2] - The trial has achieved enrollment ahead of schedule, closing screening a month earlier than expected [2] - DBV Technologies is headquartered in Châtillon, France, with operations in North America [4]

Châtillon, France, September 4, 2024 DBV Technologies to Participate in the H.C. Wainwright 26th Annual Global Investment Conference DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced that Daniel Tassé, Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright 26th Annual Global Investment Conference on Monday, September 9, 2024, at 3:00 pm ET, in New York City. A live webcast of the present ...

Information regarding the total number of voting rights and total number of shares of the Company as of July 31, 2024 (Article 223-16 of the General Regulations of the Autorité des Marchés Financiers) Market : NYSE Euronext Paris ISIN Code: FR 0010417345 Date Total number of shares Total number of voting rights 07/31/2024 96,498,927 Total gross of voting rights: 96,498,927 Total net* of voting rights: 96,214,457 * Net total = total number of voting rights attached to shares – shares without voting rights At ...

DBV Technologies S.A. (NASDAQ:DBVT) Q2 2024 Earnings Conference Call July 30, 2024 5:30 PM ET Company Participants Katie Matthews – Investor Relations Daniel Tassé – Chief Executive Officer Pharis Mohideen – Chief Medical Officer Virginie Boucinha – Chief Financial Officer Conference Call Participants Jon Wolleben – Citizens JMP Operator Welcome to the DBV Second Quarter Financial Results and Business Update Conference Call. All participants will be in a listen-only mode. [Operator Instructions] After today ...