Information regarding the total number of voting rights and total number of shares of the Company as of March 31, 2024 (Article 223-16 of the General Regulations of the Autorité des Marchés Financiers) Marke ...

Montrouge, France, March 8, 2024 DBV Technologies announces filing of 2023 Annual Report on Form 10-K and Universal Registration Document DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company focused on treatment options for food allergies and other immunologic conditions with significant unmet medical need (the "Company"), today announced the filing, for the year ended December 31, 2023, of its Annual Report on Form 10-K with the U.S. ...

DBV Technologies S.A. (NASDAQ:DBVT) Q4 2023 Earnings Conference Call March 7, 2024 5:00 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 Sushila Hernandez - Van Lanschot Kempen Operator Apologies for the late start of our conference. Welcome to the DBV Full Year 2023 Financial Results and Business Update Conference C ...

Montrouge, France, March 7, 2024 DBV Technologies Reports Full Year 2023 Financial Results and Business Update Advanced Viaskin™ Peanut clinical development programs in peanut-allergic toddlers (1 through 3 years old) and children (4 through 7 years old)Strengthened executive leadership team in preparation for BLA submissionReported cash and cash equivalents of $141 million DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company focused o ...

Exhibit 99.1 Anticipated 2024 Events Press Release Montrouge, France, March 7, 2024 DBV Technologies Reports Full Year 2023 Financial Results and Business Update DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company focused on treatment options for food allergies and other immunologic conditions with significant unmet medical need, today reported financial results for the full year 2023. The audit procedures have been substantially comp ...

Financial Performance - The company incurred net losses of $72.7 million and $96.3 million for the years ended December 31, 2023 and 2022 respectively, with an accumulated deficit of $238.9 million as of December 31, 2023[251]. - The company has not generated any product revenue to date and continues to advance the clinical and regulatory development of Viaskin Peanut in the United States and European Union[251]. - As of December 31, 2023, the company had cash and cash equivalents of $141.4 million, which is expected to fund operations until December 31, 2024[254][265]. - The company anticipates significant expenses and increasing operating losses for the foreseeable future, particularly related to the development and commercialization of Viaskin Peanut[253][263]. - Future capital requirements are expected to increase significantly due to various factors, including the need for additional financing to fund operations[285]. - The company anticipates satisfying future cash needs through a combination of equity or debt financings, collaborations, and other non-dilutive financing methods[286]. Funding and Capital Requirements - The company intends to seek additional capital through public or private equity, debt financings, collaborations, and other forms of non-dilutive financing to support its operations and product development efforts[259][266]. - There is substantial doubt regarding the company's ability to continue as a going concern, as available cash is not projected to be sufficient to support operations for at least the next 12 months[256]. - The company may need to delay or reduce the scope of its research and development efforts if it cannot secure necessary funding[261][270]. - The company is limited in its ability to raise additional share capital under French law, which may complicate future fundraising efforts[271]. Regulatory and Clinical Development - The company is conducting a Phase 3 pivotal study for Viaskin Peanut in children aged 4 to 7, with additional studies required by the FDA for safety database expansion[295]. - Regulatory approval for Viaskin products is uncertain, and the company currently has no approved drug or biological product for sale[293]. - The clinical trials for product candidates are time-consuming and expensive, with a high risk of failure impacting development and commercialization[299]. - The company may face challenges in obtaining necessary approvals for clinical trials in jurisdictions like the EU, which could impair its ability to conduct trials[296]. - Any setbacks in regulatory approval processes could have a material adverse effect on the company's business and prospects[298]. - The FDA issued a Complete Response Letter (CRL) in August 2020, indicating that the Viaskin Peanut BLA could not be approved in its current form due to concerns about system adhesion and the need for additional studies[301]. - In September 2022, the FDA imposed a partial clinical hold on the VITESSE trial, which was lifted in December 2022 after protocol revisions were made[308]. - Clinical trials are expensive and time-consuming, with potential delays due to factors such as safety and efficacy demonstrations, agreement with CROs, and subject enrollment challenges[306][307]. - The regulatory approval process is complex and may involve significant delays, with previous setbacks experienced in obtaining approval for Viaskin Peanut from the FDA and the European Commission[315]. - Fast Track designation from the FDA does not guarantee a faster development or approval process, and the FDA has the discretion to withdraw this designation[316]. - Regulatory approvals in international markets require compliance with varying requirements, which may limit the ability to market products abroad[317][320]. - Even with regulatory approvals, conditions may limit marketing capabilities, potentially impairing revenue generation[321]. Manufacturing and Supply Chain - The company relies on a single supplier for active ingredients and a single manufacturer for patches, which may impact its ability to scale production[337]. - The company has not built commercial-scale manufacturing facilities and has limited manufacturing experience with Viaskin patches, which may hinder commercialization efforts[335]. - The company’s commercialization efforts may be delayed if third-party manufacturers cannot assure a sufficient quantity of drug products for clinical trials[329]. - The company’s future profit margins may be adversely affected due to its dependence on third parties for manufacturing its product candidates[334]. - The company may not be able to produce sufficient quantities of its product candidates at an acceptable cost, impacting its financial prospects[338]. Market and Competitive Landscape - The company faces substantial competition from larger biopharmaceutical firms, which may hinder its ability to discover, develop, and commercialize products effectively[355]. - The FDA approved Xolair® (omalizumab) for reducing allergic reactions in patients with IgE-mediated food allergies, which may pose a competitive threat to the company's product candidates[358]. - Government pricing restrictions and reimbursement initiatives could negatively impact the company's revenue generation if products receive regulatory approval[360]. - The Patient Protection and Affordable Care Act (ACA) has expanded industry rebates for drugs under Medicaid, affecting pricing and reimbursement dynamics for biopharmaceutical products[361]. - The Inflation Reduction Act of 2022 introduces price negotiation for certain high-expenditure drugs, which may significantly impact the pharmaceutical industry[363]. - The company may face challenges in obtaining market acceptance for its products, which will depend on clinical efficacy, safety, and competitive pricing[357]. Legal and Compliance Risks - The company must comply with extensive legal and financial regulations as a U.S. public company, which may increase operational costs and divert management attention[287]. - The company is subject to healthcare laws and regulations that could expose it to criminal sanctions and civil penalties[388]. - Compliance with healthcare laws and regulations may incur significant costs, and violations could lead to civil, criminal, and administrative penalties, including exclusion from government-funded healthcare programs[391]. - The company may be subject to audits by the French tax authority regarding its eligibility for tax benefits, which could lead to additional corporate income tax liabilities[448]. Intellectual Property Risks - The company faces significant intellectual property risks, including potential challenges to its patents and the possibility of infringing on others' patents[405]. - The complexity of biopharmaceutical patents can lead to uncertainty in patent positions, affecting the company's competitive edge[410]. - Changes in patent laws may allow others to use the company's discoveries without compensation, impacting potential revenues[411]. - Failure to maintain patent and trade secret protection could lead to increased competition and reduced revenues[412]. - Developments in patent law, such as the America Invents Act, may affect the company's ability to obtain and enforce patents[415]. Human Resources and Management - The loss of key personnel could significantly harm the company's ability to achieve its research, development, and commercialization objectives[437]. - The company may incur significant costs from class action litigation, which could divert management's attention and resources[442]. - The company maintains liability insurance; however, if litigation costs exceed coverage, it may face substantial financial burdens[446]. Economic and Geopolitical Factors - Economic downturns, inflation, and geopolitical events could adversely affect the company's financial performance and ability to raise capital[274][276]. - The ongoing military conflict between Hamas and Israel may disrupt supply chains and adversely affect clinical trials, with unpredictable economic impacts[280]. - The UK’s withdrawal from the EU may negatively affect global economic conditions and the company's business, potentially reducing share prices[379]. - Regulatory changes post-Brexit could increase costs and impact the ability to commercialize product candidates in the UK and EU[386].

Montrouge, France, March 4, 2024 DBV Technologies to Report Full Year 2023 Financial Results and Business Update on March 7, 2024 DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company focused on treatments for food allergies, today announced the Company will host a conference call and live audio webcast on Thursday, March 7th, at 5:00 p.m. ET to review full year 2023 financial results and provide a business update. Interested participan ...

Montrouge, France, March 4, 2024 DBV Technologies to Report Full Year 2023 Financial Results and Business Update on March 7, 2024 DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company focused on treatments for food allergies, today announced the Company will host a conference call and live audio webcast on Thursday, March 7th, at 5:00 p.m. ET to review full year 2023 financial results and provide a business update. Interested participan ...

DBV Technologies S.A. (NASDAQ:DBVT) Q3 2023 Earnings Conference Call October 31, 2023 5:00 PM ET Company Participants Katie Matthews - Head of Investor Relations Daniel Tassé - Chief Executive Officer Pharis Mohideen - Chief Medical Officer Conference Call Participants Rajan Sharma - Goldman Sachs Operator Welcome to the DBV's Third Quarter Financial Results and Business and Regulatory Update Conference Call. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conf ...

Financial Performance - Operating income increased by 14% to $2.4 million in Q3 2023 compared to $2.1 million in Q3 2022, driven by revenue from the Nestlé collaboration agreement[101][102][103] - Net loss improved by 3% to $16.7 million in Q3 2023 compared to $17.3 million in Q3 2022[101] - Net loss for the nine months ended September 30, 2023 was $61.5 million, an increase of 8% compared to $57.0 million in the same period of 2022[114] - Operating income increased by 11% to $6.9 million for the nine months ended September 30, 2023, driven by a $0.5 million increase in the French research tax credit[115][116] - Net loss for the nine months ended September 30, 2023 was $61.5 million, compared to $57.0 million in the same period in 2022, representing an 8% increase[114] - The company has incurred net losses annually since inception, primarily due to development programs and administrative expenses[129] Research and Development - Research and Development expenses increased from $3.186 million in Q3 2022 to $3.663 million in Q3 2023[81] - Research and development expenses decreased by 9% to $13.8 million in Q3 2023 from $15.1 million in Q3 2022, primarily due to a $4.2 million reversal of loss at completion for the Nestlé Phase II trial[101][105] - External clinical-related expenses increased by 10% to $12.3 million in Q3 2023 from $11.1 million in Q3 2022, driven by differences in clinical trial phasing[105][106] - Employee-related costs (excluding share-based payments) for R&D increased by 21% to $3.2 million in Q3 2023 from $2.6 million in Q3 2022, supporting the VITESSE trial and new toddler safety study[105][106] - Research and Development expenses increased by 3% to $47.4 million for the nine months ended September 30, 2023, primarily due to a $4.0 million increase in external clinical-related expenses[119] - Research and development expenses totaled $47.4 million for the nine months ended September 30, 2023, an increase of $1.5 million compared to the same period in 2022[22] Clinical Trials and Safety Studies - The company plans to initiate a safety study with approximately 275 additional subjects to supplement the safety data from the VITESSE trial[94] - The FDA confirmed that the Phase 3 EPITOPE study meets pre-specified criteria for success, requiring additional safety data for BLA submission[96] - The company expects topline results from the VITESSE trial in the first half of 2025[95] - The COMFORT Toddlers safety study will enroll approximately 400 subjects with a 3:1 randomization (active:placebo)[98] - The company's Viaskin Peanut program has been evaluated in nine clinical trials, including four Phase 2 trials and three completed Phase 3 trials[93] Expenses and Costs - Total personnel expenses increased from $4.922 million in Q3 2022 to $6.724 million in Q3 2023[81] - Sales and marketing expenses increased by 318% to $0.7 million in Q3 2023 from $0.2 million in Q3 2022, mainly due to higher external professional services[101][107] - General and administrative expenses increased by 28% to $6.2 million in Q3 2023 from $4.8 million in Q3 2022[101] - General and Administrative expenses increased by 30% to $22.3 million for the nine months ended September 30, 2023, mainly due to $2.2 million in one-time costs related to financing activities and organizational planning[122][123] - Sales and Marketing expenses decreased by 3% to $1.6 million for the nine months ended September 30, 2023, primarily due to a $0.3 million decrease in employee-related costs[121] - General and administrative expenses increased by $5.1 million to $22.3 million for the nine months ended September 30, 2023[22] - The company recorded a provision of $0.8 million as of September 30, 2023, for potential costs if the Montrouge office lease agreement is not renewed[123] Cash Flow and Liquidity - Total cash and cash equivalents decreased from $209.194 million in December 2022 to $149.135 million in September 2023[63] - Net cash used in operating activities was $66.0 million for the nine months ended September 30, 2023, compared to $31.8 million in the same period of 2022[127] - Cash and cash equivalents decreased to $149.1 million as of September 30, 2023, from $209.2 million as of December 31, 2022[127] - Net cash flows provided by financing activities were $7.0 million for the nine months ended September 30, 2023, compared to $194.4 million in the same period of 2022[127] - The company expects its cash and cash equivalents to fund operations for at least the next 12 months[128] - Net cash flow used in operating activities increased by $34.2 million (108%) to $66.0 million for the nine months ended September 30, 2023[140][141] - Net cash flow provided by financing activities decreased by $187.4 million (-96%) to $7.0 million for the nine months ended September 30, 2023[140][143] - The company issued $15.3 million and $7.8 million in new Ordinary Shares through its ATM program in May 2022 and June 2023, respectively[132] - The company's corporate headquarters in Montrouge, France represents a $1.2 million cash requirement as of September 30, 2023[134] - The company's U.S. office in Basking Ridge, New Jersey represents a $0.1 million cash requirement as of September 30, 2023[135] - The company may seek additional capital through public or private equity, debt financings, collaborations, or other non-dilutive financings to support the potential launch of Viaskin Peanut and other R&D efforts[130] - The company established an ATM program to sell up to $100 million in ADSs, with $15.3 million and $7.8 million raised in May 2022 and June 2023, respectively[131][132] - Net cash flow used in investing activities increased by $0.6 million (839%) to $0.6 million for the nine months ended September 30, 2023[140][142] - The company's corporate headquarters lease in Montrouge, France, represents a $1.2 million cash requirement as of September 30, 2023[134] - The company's U.S. office lease in Basking Ridge, New Jersey, represents a $0.1 million cash requirement as of September 30, 2023[135] Financial Income and Tax Credits - Financial income increased by 110% to $1.5 million in Q3 2023 from $0.7 million in Q3 2022[101] - Other operating income increased by 70% to $1.1 million in Q3 2023 from $0.7 million in Q3 2022[102] - Research tax credit decreased by 12% to $1.2 million in Q3 2023 from $1.4 million in Q3 2022[102] - Financial income increased by 79% to $3.0 million for the nine months ended September 30, 2023, compared to $1.7 million in the same period of 2022[124] Corporate and Organizational Updates - The company announced the appointment of Virginie Boucinha as CFO effective November 6, 2023[88] - The company qualifies as a smaller reporting company, with potential market value thresholds of $250 million or $700 million depending on revenue and shareholding criteria[145]