DBV Technologies S.A. 10-K

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations. You should read this discussion and analysis of our financial condition and consolidated results of operations together with the consolidated financial statements, related notes and other financial information included in this Annual Report on Form 10-K. Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report on Form 10-K, including statements of our plans, objectives, expectations and intentions, contain forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Risk Factors” section of this Annual Report on Form 10-K, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. Please also see the section titled “Forward-Looking Statements.” Overview We are a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin. Our therapeutic approach is based on epicutaneous immunotherapy, or EPIT, our proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin, an epicutaneous patch (i.e., a skin patch). We have generated significant data demonstrating that Viaskin’s mechanism of action is novel and differentiated. Viaskin targets specific antigen-presenting immune cells in the skin, called Langerhans cells, that capture the antigen and migrate to the lymph node in order to activate the immune system without passage of the antigen into the bloodstream, minimizing systemic exposure in the body. We are advancing this unique technology to treat children suffering from food allergies, for whom safety is paramount, since the introduction of the offending allergen into their bloodstream can cause severe or life-threatening allergic reactions, such as anaphylactic shock. We believe Viaskin may offer convenient, self-administered, non-invasive immunotherapy to patients, if approved. Our most advanced product candidate is Viaskin Peanut, which has been evaluated as a potential therapy for children with peanut allergy in twelve clinical trials, including three Phase 2 trials and four completed Phase 3 trials. We have two ongoing Phase 3 trial of Viaskin Peanut in children ages one to three and ages four to seven with peanut allergy. Financial Overview Since our inception, we have primarily funded our operations with equity financings, and, to a lesser extent, public assistance aimed at supporting innovation and payments associated with research tax credit (crédit d’impôt recherche). We do not generate product revenue and continue to prepare for the potential launch of our first product in the United States and in the European Union, if approved. The Company has incurred operating losses and negative cash flows from operations since inception. Subsequent to December 31, 2024, the Company raised additional proceeds in a private placement financing (the “2025 PIPE”) consisting of i) a share capital increase without preferential subscription rights reserved to categories of persons satisfying determined characteristics pursuant to the 24th resolution of the general meeting of shareholders of May 16, 2024 (the "2024 General Meeting") completed on April 7 2025 for an amount of €38 million, consisting of the issuance of (i) 34,090,004 new shares at a par value of €0.10 (the "New Shares") each with warrants of the Company attached (the "ABSA Warrants", and together with the New Shares, the "ABSA") at a subscription price of €1.1136 per ABSA and (ii) up to 59,657,507 additional new shares, if all the ABSA Warrants attached to the New Shares are exercised (the "ABSA Warrant Shares"); and ii) the issue through an offering reserved to categories of persons satisfying determined characteristics of 71,005,656 units (the “PFW-BS-PFW”) completed on April 7, 2025 for an amount of €79 million at a subscription price of €1.1136 per PFW-BS-PFW (of which €1.1036 will have been prefunded on the issue date), each PFW-BS-PFW consisting of one pre-funded warrant to subscribe for one share of the Company (the "First Pre-Funded Warrants") and one warrant (the "BS Warrants") to subscribe to one second pre-funded warrants (the "Second Pre-Funded Warrants"), each of which entitles the holder to subscribe for 1.75 shares of the Company (the "Second PFW Shares"), allowing to issue up to 71,005,656 additional new shares if all the First Pre-Funded Warrants are exercised (the "First PFW Shares") and up to 124,259,898 additional new shares if all the Second Pre-Funded Warrants are exercised (the "Second PFW Shares", together with the ABSA Warrant Shares and the First Pre-Funded Warrant Shares, the "Warrant Shares", and together with the New Shares, the "Offered Shares"). The Company received initial net proceeds of $125.5 million (€116.3 million) on April 7, 2025, and based on our current operations, plans and assumptions, we estimate that our balance of cash and cash equivalents will be sufficient to fund our operations into June 2026. We further estimate that, following the potential issuance of all Warrant Shares in the financing, representing potential additional gross proceeds of up to $181.4 million (€168.2 million), we could extend our financial visibility into 2028 and through potential commercialization of Viaskin Peanut in the U.S, if approved. We imay needadditional capital as we prepare for the launch of Viaskin Peanut, if approved, and continue other research and development efforts. We may seek to finance our future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of non-dilutive financings. We cannot guarantee that we will be able to obtain the necessary financing to meet our needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets resulting from geopolitical instability, macroeconomic conditions, global health crises, or other factors. If we are not successful in our financing objectives, we could have to scale back our operations, notably by delaying or reducing the scope of our research and development efforts or obtain financing through arrangements with collaborators or others that may require us to relinquish rights to our product candidates that we might otherwise seek to develop or commercialize independently. We anticipate that our expenses will increase substantially in connection with our ongoing activities, as we: • continue our research, pre-clinical and clinical development of our product candidates, in particular expanding the scope of our trials for Viaskin Peanut; • seek regulatory and marketing approvals and pursue commercial activities for Viaskin Peanut, primarily in North America and in the European Union; • seek regulatory and marketing approvals for our other product candidates that successfully complete clinical trials; • establish a sales, marketing and distribution infrastructure to commercialize Viaskin Peanut, if approved, and any other products for which we may obtain marketing approval, especially in North America and in the European Union; • further develop the manufacturing process for our product candidates; • change or add additional manufacturers or suppliers; • initiate and conduct any post-approval clinical trials, if required by the FDA or by the EMA, for our approved products, if any; • initiate additional pre-clinical, clinical or other studies for our product candidates; • seek to identify and validate additional product candidates; • acquire or in-license other product candidates and technologies; • make milestone or meet other payments deadlines under any in-license agreements; • maintain, protect and expand our intellectual property portfolio; • attract and retain new and existing skilled personnel; • add operational, financial and management information systems and personnel, including personnel to support our product development and commercialization efforts, as well as a company listed on both the U.S. and French stock markets; • experience any delays or encounter issues with any of the above. Our Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company has incurred operating losses and negative cash flows from operations since inception. The Company does not generate product revenue and continues to prepare for the potential launch of its first product in the United States and in the European Union, if approved. Since its inception, the Company has primarily funded its operations through equity financings, as well as public assistance and research tax credit. Prior to 2022, the Company underwent restructuring efforts, scaled down certain clinical programs, and engaged with regulatory authorities to advance Viaskin Peanut’s approval process in the United States and European Union. In 2022, the Company secured a private placement financing of $194 million and lifted a partial clinical hold from the FDA on its VITESSE Phase 3 clinical study. On April 7, 2025, the Company received gross proceeds of $125.5 million (€116.3 million) from the issuance of the ABSA and PFW-BS-PFW, as described in Note 20. With the receipt of the aforementioned proceeds, and based on its current operations, plans, and assumptions examined by the Board on March 23, 2025, the Company estimates that its cash and cash equivalents are sufficient to fund its operations into June 2026. Furthermore, should all Warrant Shares be issued, representing potential additional gross proceeds of up to $181.4 million (€168.2 million), the Company estimates that it could extend its financial visibility into 2028, covering the period through the potential commercialization of Viaskin Peanut in the U.S., if approved. Given the Company’s historical operating losses and reliance on external financings, the Company may still seek additional capital for future needs through a combination of public or private equity or debt financings, collaborations, licensing agreements, and other funding options. While recent financing events have improved the Company’s financial position, access to additional capital in the future remains subject to market conditions and investor interest. Business Trends We engage in substantial research and development efforts to develop innovative pharmaceutical product candidates. Research and development expense consists primarily of: • cost of third-party contractors such as contract research organizations, or CROs, that conduct our non-clinical studies and clinical trials; • personnel costs, including salaries, related benefits and share-based compensation, for our employees engaged in scientific research and development functions; • purchases, real-estate leasing costs, as well as conferences and travel costs; and • depreciation, amortization and provisions. Our direct research and development expenses consist principally of external costs, such as startup fees paid to investigators, consultants, central laboratories, and CROs in connection with our clinical trials, and costs related to acquiring and manufacturing clinical study materials. We do not allocate personnel-related costs, costs associated with our general platform improvements, depreciation or other indirect costs to specific programs, as they are deployed across multiple projects under development and, as such, are separately classified as personnel and other expenses. Research and Development activities are central to our business. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect that our Research and Development expenses will continue to increase in the foreseeable future as we initiate clinical trials for certain product candidates and pursue later stages of clinical development of our product candidates. In the year ended December 31, 2024, we spent $89.3 million in Research and Development expenses to advance the development of our product candidates. The following table provides a breakdown of our direct Research and Development expenses for our two lead development programs, as well as expenses not allocated to the programs and share-based compensation expenses included in Research and Development expenses, for the years ended December 31, 2024 and 2023, respectively: December 31, 2024 2023 Viaskin Peanut(1) 80,479 60,329 As a percentage of research and development expenses, excluding share- 93 % 105 % based compensation Expense(2) Research and development expenses related to Viaskin Milk(1) 3,638 6,019 As a percentage of research and development expenses excluding share-based compensation Expense(3) 4 % 10 % Other research and development expenses(1) 2,881 (8,621) Total research and development expenses, excluding share-based compensation expense 86,999 57,727 Share-based compensation expenses included in research and development expenses 2,343 2,496 Total research and development expenses 89,343 60,223 (1) Excludes employee share-based compensation expense after $19.9 million loss on completion accrual reversal as of December 2023. (2) If we exclude MAG1C impact the percentage of research and development expenses related to Viaskin Peanut in 2023 would be 84%. (3) If we exclude MAG1C impact the percentage of research and development expenses related to Viaskin Milk in 2023 would be 8%. We cannot determine with certainty the duration and completion costs of the current or future clinical trials of our product candidates or if, when, or to what extent we will generate revenue from the commercialization and sale of any of our product candidates that obtain regulatory approval. We may never succeed in achieving regulatory approval for any of our product candidates. The duration, costs and timing of clinical trials and development of our product candidates will depend on a variety of factors, many of which are outside of our control including: • the FDA’s approval of our BLA for Viaskin Peanut; • the costs of future commercialization activities, including product sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval, especially in North America; • the costs of securing manufacturing arrangements for commercial production; • revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval; • the scope, progress in, results and the costs of, our pre-clinical studies and clinical trials and other research and development programs, particularly as we seek regulatory and marketing approvals for our product candidates that successfully complete clinical trials; • the scope, prioritization and number of our research and development programs; • the costs, timing and outcome of regulatory review of our product candidates; • the achievement of milestones or occurrence of other developments that trigger payments under our existing collaboration agreements, and any additional collaboration agreements we may enter into; • the extent to which we are obligated to reimburse, or entitled to reimbursement of, clinical trial costs under any collaboration agreements or future collaborations, if any; and • the costs involved in filing, prosecuting, enforcing and defending patent claims and other intellectual property rights. A change in the outcome of any of these variables with respect to the development and commercialization of Viaskin Peanut, if approved, or any other product candidate that we are developing could mean a significant change in the costs and timing associated with the development and commercialization of Viaskin Peanut, if approved, or such other product candidate. For example, if the FDA or other regulatory authority were to require us to conduct pre-clinical and clinical trials beyond those which we currently anticipate will be required for the completion of clinical development, if we experience significant delays in enrollment in any clinical trials or if the FDA or other regulatory authority were to require us to conduct post-approval clinical trials, we could be required to spend significant additional financial resources and time on the completion of the clinical development and potential launch of commercialization. Components of Our Results of Operations Operating Income Our operating income consists of other operating income, as described below, as we generated no revenue from our operating activities in 2024 or 2023. Other Operating Income Research Tax Credits The research tax credit ( crédit d’impôt recherche , or CIR) is granted to companies by the French tax authorities in order to encourage them to conduct technical and scientific research. Companies that prove that they have expenditures that meet the required criteria receive a tax credit that can be used for the payment of the corporate tax due for the fiscal year in which the expenditures were made and the next three fiscal years, or, as applicable, can be reimbursed for the excess portion. The expenditures taken into account for the calculation of the research tax credit involve only research expenses. If a company meets certain criteria in terms of sales, headcount or assets to be considered a Small and Medium-sized Enterprises, or SMEs, under EU law, immediate payment of the CIR can be requested. After two consecutive years in 2019 and 2020 without the SME status, we recovered our SME status, beginning in the fiscal year ending December 31, 2021, and became therefore eligible again for the immediate reimbursement of the CIR. During the fiscal year ended December 31, 2023, the Company received the reimbursement of the 2022 fiscal year research tax credit for a total amount of $5.9 million. During the fiscal year ended December 31, 2024, the Company received the reimbursement of the 2023 fiscal year research tax credit for a total amount of $8.7million, including 2020, 2021 and 2022 complementary research tax credit made during the fiscal year ended December 31, 2023. Collaboration Agreement with Nestlé Health Science In May 2016, we entered into a Development Collaboration and License Agreement (the “Collaboration Agreement”) with Société des Produits Nestlé S.A. (formerly NESTEC S.A.) (“NESTEC”). The Collaboration Agreement related to an exclusive global collaboration with Nestlé Health Science for the development and, if approved, commercialization of MAG1C, a ready-to-use and standardized atopy patch test tool for the diagnosis of CMPA (non-mediated IgE) in infants. Under the terms of the Collaboration Agreement, the Company was responsible for leading the development activities of MAG1C up through a pivotal Phase 3 clinical program, and if the appropriate regulatory approvals were received, Nestlé Health Science would support the commercialization of MAG1C globally. The Company was eligible to receive up to €100.0 million ($105.0 million at December 31, 2023 closing exchange rate) in potential development, clinical, regulatory and commercial milestones, including an upfront payment of €10.0 million received in July 2016. On October 30, 2023, the Company and NESTEC entered into a Mutual Termination Letter Agreement terminating the Collaboration Agreement. Each party remains responsible for its own costs and expenses related to its respective wind-down activities. Any and all licenses and sublicenses, granted by either party to the other party under the Collaboration Agreement, including, without limitation, any licenses to intellectual property, were revoked and terminated. Consequently, since signing the Mutual Termination Letter Agreement and as of December 31, 2023, we had recorded the following: • Loss on completion accrual reversal of $19.9 million (Other Operating Income); • Deferred revenue accrual reversal of $6.9 million (Operating Expenses); • An Accrual of $2.3 million for the remaining expenses related to the ongoing clinical study fully expensed in 2024. Operating Expenses Since our inception, our operating expenses have consisted primarily of Research and Development activities, General and Administration costs and to lesser extent sales and marketing costs. Research and Development Expenses Research and Development expenses comprise clinical trials direct costs as well as salaries, share-based payments and benefits for internal Research and Development personnel. Consultants, costs of clinical trials costs related to manufacturing clinical study materials, sponsored research, clinical trials insurance, other external costs, depreciation (of Research and Development equipment and other costs related to Research and Development like loss on completion on MAG1C study until December 31, 2023), and facility costs related to the development of drug candidates. The Company records upfront, non-refundable payments made to outside vendors, or other payments made in advance of services performed or goods being delivered, as prepaid expenses, which are expensed as services are performed or the goods are delivered. Certain Research and Development projects are, or have been, partially funded by collaboration agreements. The Company records the related reimbursement of research and development costs under these agreements as income in the period in which such costs are incurred. Sales and Marketing Sales and marketing expense consists primarily of personnel costs, consultant fees and share-based compensation for sales and marketing employees, as well as fees related to pre-commercialization activities for Viaskin Peanut in North America and in the European Union. We anticipate that our sales and marketing expenses will increase significantly in the future as we prepare for the potential launch and commercialization of Viaskin Peanut in North America and in the European Union, if approved. General and Administrative General and Administrative expenses consist primarily of personnel costs including share-based compensation for Finance, Legal, IT, Human Resources and other Administrative employees. General and Administrative expense also consists of Information Systems architecture, software licenses, IT equipment and, to obtaining a directors and officers liability insurance policy and fees for professional services, mainly related to audit, tax and legal services, real-estate leasing costs, insurance costs, consulting costs, investor relations costs and corporate communication and travel costs. We anticipate that our General and Administrative expenses will increase in the future to support the expected growth in our Research and Development activities and the potential launch and commercialization of Viaskin Peanut in North America and in European Union, if approved. We also anticipate continued increased expenses associated with being a public company in the United States. Finance Income (Expense) Our cash and cash equivalents have been deposited primarily in savings and deposit accounts with a short term remaining maturity at the date of purchase or less, refundable within 32 days or less, for which the risk of changes in value is considered to be insignificant. Savings and deposit accounts generate a limited amount of interest income, with very low counterparty risks. We expect to continue this investment strategy. Results of Operations Comparison of the Years Ended December 31, 2024 and 2023 The following table summarizes the results of our operations, derived from our consolidated financial statements, prepared in compliance with generally accepted accounting principles in the United States, or U.S. GAAP, for the years ended December 31, 2024 and 2023: December 31, 2024 2023 $ change % of change Operating income 4,151 15,728 (11,577) (74) % Operating expenses Research and development expenses (89,342) (60,223) (29,119) 48 % Sales and marketing expenses (2,659) (2,438) (222) 9 % General and administrative expenses (28,739) (29,500) 762 (3) % Total Operating expenses (120,740) (92,161) (28,579) 31 % Loss from operations (116,589) (76,432) (40,157) 53 % Financial income (expense) 2,726 3,714 (987) (27) % Loss before taxes (113,863) (72,719) (41,144) 57 % Income tax (55) (7) (49) 721 % Net loss (113,918) (72,726) (41,192) 57 % Basic/diluted Net loss per share attributable to shareholders (1.17) (0.76) — — Operating Income The following table summarizes our operating income for the years presented: December 31, 2024 2023 $ change % of change Sales — — — — Other income 4,151 15,728 (11,577) (74) % Research tax credit 4,146 8,766 (4,620) (53) % Other operating income 5 6,962 (6,957) (100) % Total operating income 4,151 15,728 (11,577) (74) % We generated operating income of $4.2 million for the year ended December 31, 2024 compared to $15.7 million for the year ended December 31, 2023. The decrease in operating income is due to a lower Research Tax Credit. and nil revenue recognition from January 1, 2024 onward due to the termination of the Collaboration Agreement with NESTEC. The decrease of theResearch Tax Credit. by $(4.6) million for the year ended December 31, 2024 compared to the year ended December 31, 2023 is mainly due to a corrective Research Tax Credit. filed in 2023 by the Company for $2.9 million for 2020, 2021 and 2022 fiscal year and a greater proportion of clinical study activities carried out in North America in 2024 compared to 2023 not eligible for the Research Tax Credit. Other operating income decreased by $(7.0) million for the year ended December 31, 2024 compared to the year ended December 31, 2023 mainly due to the reversal of deferred revenue following the Mutual Termination Letter Agreement, effective October 30, 2023, of the Collaboration Agreement between the Company and NESTEC. Operating Expenses Research and Development Expenses The following table summarizes our research and development expenses for the years presented: December 31, 2024 2023 $ change % of change Research and Development expenses External clinical-related expenses 62,448 49,044 13,404 27 % Employee-related costs 17,213 14,401 2,812 20 % Share-based payment expenses 2,343 2,496 (153) (6) % Depreciation and amortization (719) (13,658) 12,939 (95) % Other costs 8,058 7,940 118 1 % Total Research and Development expenses 89,342 60,223 29,120 48 % Research and Development expenses increased by $29.1 million for the year ended December 31, 2024 compared to the year ended December 31, 2023, mainly due to external clinical-related expenses increasing by $13.4 million from both an increase in participant enrollment in the VITESSE Phase 3 clinical trial and the preparatory activities for the COMFORT studies. Employee-related costs, excluding share-based payments, increased by $2.8 million for the year ended December 31, 2024 compared to the year ended December 31, 2023 due to the recruitment of 12 full-time employees (“FTE”) in Medical, Quality and Regulatory Affairs, mostly based in the U.S. Depreciation, amortization and other costs increased by $12.9 million for the year ended December 31, 2024 compared to the year ended December 31, 2023, mainly due to (1) the termination of the Collaboration Agreement with NESTEC that explained the accrual net reversal in 2023, (2) accruals reversals on CRO activities, and (3) Medical, Quality and Regulatory Affairs activities. Sales and Marketing Expenses The following table summarizes our sales and marketing expenses for the years presented: December 31, 2024 2023 $ change % of change Sales & Marketing expenses External professional services and other costs 1,770 1,684 86 5 % Employee-related costs incl. share-based payment expenses 890 754 136 18 % Total Sales & Marketing expenses 2,659 2,438 222 9 % Sales and marketing expenses increased by $0.2 million for the year ended December 31, 2024 compared to the year ended December 31, 2023, primarily to support pre-commercialization activities for Viaskin Peanut in North America. General and Administrative Expenses The following table summarizes our general and administrative expenses for the years presented: December 31, 2024 2023 $ change % of change General & Administrative expenses External professional services 10,052 8,750 1,302 15 % Employee-related costs 8,981 8,201 780 10 % Share-based payment expenses 2,161 3,388 (1,227) (36) % Depreciation, amortization and other costs 7,545 9,161 (1,617) (18) % Total General & Administrative expenses 28,739 29,500 (762) (3) % General and administrative expenses decreased by $(0.8) million for the year ended December 31, 2024, compared to the year ended December 31, 2023. External professional services increased by $1.3 million for the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due to one-time costs associated with (1) office moves in France and the U.S, (2) financing activities and (3) trademark and patent activities. This increase is offset by a decrease in Depreciation, amortization and other costs by $(1.6) million for the year ended December 31, 2024, compared to the year ended December 31, 2023 primarily due to the accrual reversal on the Montrouge office revamping. Financial income (loss) Our financial income was $2.7 million in 2024 and $3.7 million in 2023, and primarily includes the financial income on our financial assets and foreign exchange gains. Income tax Our income tax expense was $55 thousand for the year ended December 31, 2024, compared to an income tax expense of $7 thousand for the year ended December 31, 2023. Net loss Net loss was $113.9 million for the year ended December 31, 2024, compared to $72.7 million for the year ended December 31, 2023. Net loss per share (based on the weighted average number of shares outstanding over the period) was $1.17 and $0.76 for the year ended December 31, 2024 and 2023, respectively. Liquidity and Capital Resources Financial Condition On December 31, 2024, we held $32.5 million in cash and cash equivalents compared to $141.4 million of cash and cash equivalents on December 31, 2023. Net cash used for operating activities was $104.5 million and $79.7 million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, we recorded a net loss of $113.9 million. Our net cash flows provided by financing activities totaled $0.6 million in 2024 and $6.8 million in 2023, mainly consisting of the proceeds from our ATM program., Sources of Liquidity and Material Cash Requirements Subsequent to December 31, 2024, the Company raised additional proceeds in the 2025 PIPE of initial net proceeds of $125.5 million (€116.3 million) received on April 7, 2025, and based on our current operations, plans and assumptions, we estimate that our balance of cash and cash equivalents will be sufficient to fund our operations into June 2026. We further estimate that, following the potential issuance of all Warrant Shares in the financing, representing potential additional gross proceeds of up to $181.4 million (€168.2 million), we could extend our financial visibility into 2028 and through potential commercialization of Viaskin Peanut in the U.S, if approved. In May 2022, we established an At-The-Market (“ATM”) program to offer and sell, including with unsolicited investors who have expressed an interest, a total gross amount of up to $100 million of American Depositary Shares (“ADSs”), each ADS representing one-half of one ordinary share of the Company. The ATM program is intended to be effective through the expiration of the Company’s existing registration statement registering the ADSs to be issued under the ATM program, i.e. until July 16, 2024, unless terminated prior to such date in accordance with the sales agreement or the maximum amount of the program has been reached. The Company intent is to use the net proceeds, if any, of sales of ADSs issued under the program, together with its existing cash and cash equivalents, primarily for activities associated with potential approval and launch of Viaskin Peanut, as well as to advance the development of the Company’s product candidates using its Viaskin Platform and for working capital and other general corporate purposes. Pursuant to the ATM program, the Company issued and completed sales of new Ordinary Shares in the form of ADSs for a total gross amount of $15.3 million on May 4, 2022, and of $7.8 million on June 14, 2023. Respectively, 6,036,238 and 2,052,450 new Ordinary Shares in the form of ADSs were issued through a capital increase without preferential subscription rights of the shareholders reserved to specific categories of persons fulfilling certain characteristics (the “ATM issuance”), at a unit subscription price of $1.27 and $1.90 per ADS, each ADS giving the right to receive one-half of one ordinary share of the Company. During the years ended December 31, 2023 and 2022, we obtained the following financing on the public markets by issuance of securities, net of commissions and estimated offering expenses: Equity capital Bank loan Other debt Total 2022 194,446 — — 194,446 2023 6,921 — — 6,921 Total 201,367 — — 201,367 We have incurred net losses each year since our inception. Substantially all of our net losses resulted from costs incurred in connection with our development programs and from general and administrative expenses associated with our operations. We have not incurred any bank debt. We may seek additional capital as we prepare for the launch of Viaskin Peanut, if approved, and continue other research and development efforts. We may seek to finance our future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of non-dilutive financings. We cannot guarantee that we will be able to obtain the necessary financing to meet our needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets due any future pandemics, epidemics or global health crises and conflict in Ukraine or other global political or military crises. A severe or prolonged economic downturn could result in a variety of risks to us, including reduced ability to raise additional capital when needed or on acceptable terms, if at all. If we are not successful in our financing objectives, we could have to scale back its operations, notably by delaying or reducing the scope of our research and development efforts or obtain financing through arrangements with collaborators or others that may require us to relinquish rights to our product candidates that we might otherwise seek to develop or commercialize independently. The following table presents our material expenses commitments for future periods: Material Cash Requirements Due by the Year Ended December 31, 2025 2026 2027 Thereafter Total (Amounts in thousands) Operating leases 836 1,228 1,237 5,136 8,437 Purchase obligations - Obligations Under the Terms of CRO Agreements 8,439 1,541 502 48 10,530 Total 9,275 2,769 1,739 5,184 18,967 The commitment amounts in the table above are associated with contracts that are enforceable and legally binding and that specify all significant terms, including interest on long-term debt, fixed or minimum services to be used, fixed, minimum or variable price provisions, and the approximate timing of the actions under the contracts. The table does not include obligations under agreements that we can cancel without a significant penalty. Future events could cause actual payments to differ from these estimates. Operating leases In November 2023, the Company entered into new agreements to relocate its headquarters in Châtillon, France: • a short term lease agreement for the fitting works of the new offices, • a lease agreement starting April 16, 2024 with a minimum duration of six years. Our corporate headquarters represents a $6.3 million cash requirement as of December 31, 2024 until April 2033. In light of the current stage of regulatory interactions regarding Viaskin Peanut, we achieved the resizing of our facility use in North America to support our U.S. subsidiary as well as future commercialization needs, explaining partially operating leases costs as of December 31, 2024 and December 31, 2023: • Our primary U.S. office is located in Warren, New Jersey. In February 2024, we entered into a lease agreement commencing on March 19, 2024 and effective for 70 months, for an office of 16,704 square feet. The office represents a $1.8 million cash requirement as of December 31, 2024 which expires December 1, 2029. • We also have facilities located in Basking Ridge, New Jersey initially intended to support our U.S. operations. In March 2022, we entered into a lease agreement, commencing on April 1, 2022 and effective for 38 months, for an office of 579 square feet. The Basking Ridge office represent a $0.1 million cash requirement as of December 31, 2024 which expires June 1, 2025. Purchase obligations—Obligations Under the Terms of CRO Agreements In connection with the launch of our clinical trials for Viaskin Peanut and Viaskin Milk, we signed agreements with several contract research organizations. As of December 31, 2024, expenses associated with the ongoing trials amounted globally to $170.3 million, and we had non-cancellable contractual obligations with CRO until the year ended 2026 amounting to $10.0 million. Cash flows The table below summarizes our sources and uses of cash for the years ended December 31, 2024 and 2023. December 31, (Amounts in thousands of U.S. Dollars) 2024 2023 $ change % of change Net cash flow used in operating activities (104,474) (79,653) (24,821) 31 % Net cash flow used in investing activities (757.0) (808.3) 51.304 (6) % Net cash flow provided by financing activities 587 6,767 (6,180) (91) % Effect of exchange rate changes on cash and cash equivalents (4,268) 5,867 (10,135) (173) % Net (decrease) increase in cash and cash equivalents (108,913) (67,827) (41,085) 61 % Operating Activities Our net cash flows used in operating activities were $104.5 million and $79.7 million in 2024 and 2023 respectively. Our net cash flows used in operating activities increased by $24.8 million or 31% The variance is mainly driven by the increase in external clinical related expenses by $11.9 million and in Regulatory and Manufacturing activity-related expenses by $10.5 million. Investing Activities Our net cash flows used in investing activities were $0.8 million in 2024 and $0.8 million in 2023. Financing Activities Our net cash flows resulting from financing activities were $0.6 million in 2024 and $6.8 million in 2023 from the ATM. Consistent with customary practice in the French securities market, we entered into a liquidity agreement ( contrat de liquidité ) with Natixis on April 13, 2012. The liquidity agreement complies with applicable laws and regulations in France. The liquidity agreement authorizes Natixis to carry out market purchases and sales of our shares on Euronext Paris. The amount is classified in other non-current financial assets in our statement of financial position. At December 31, 2024, 266,868 shares and $0.1 million were in the liquidity account. The liquidity agreement has a term of one year and will renew automatically unless otherwise terminated by either party. Critical Accounting Policies and Significant Judgments and Estimates Our financial statements are prepared in accordance with U.S. GAAP. Some of the accounting methods and policies used in preparing our financial statements under U.S. GAAP are based on complex and subjective assessments by our management or on estimates based on past experience and assumptions deemed realistic and reasonable based on the facts and circumstances concerned. The actual value of our assets, liabilities and shareholders’ equity and of our earnings could differ from the value derived from these estimates if conditions changed and these changes had an impact on the assumptions adopted. We believe that the most significant management judgments and assumptions in the preparation of our financial statements are described below. See Note 1 to our financial statements for a description of our other significant accounting policies. Revenue Recognition—Collaboration Agreement with Nestlé Health Science On May 31, 2016, we announced our entry into an exclusive global collaboration with Nestlé Health Science to develop MAG1C, a ready-to-use and standardized atopy patch test tool for the diagnosis of cow’s milk protein allergy in infants and toddlers. Under the terms of the exclusive collaboration, we are responsible for leading the development activities of MAG1C up through a pivotal Phase 3 clinical program, and if appropriate regulatory approvals are received, Nestlé Health Science will support the commercialization of MAG1C globally, while prioritizing certain agreed-upon countries. We entered into an amendment with Nestlé Health Science on July 12, 2018. We are eligible to receive up to €100.0 million in potential development, clinical, regulatory and commercial milestones, inclusive of a non-refundable upfront payment of €10.0 million that we received in July 2016. Effective October 30, 2023, the Company and Nestlé Health Science signed an agreement, terminating the collaboration agreement between the two parties and the PII clinical study by which upfront and milestones 1 to 3 are definitively acquired by DBV. Consequently, as of the signing of the Mutual Termination Letter Agreement and as of December 31, 2023, we recorded the following: • Loss on completion accrual reversal $19,9 million; • Deferred revenue accrual reversal $6.9 million; • Accrual for ongoing Clinical study completion of $2.3 million as of December 31, 2023. This updated accrual of $22 thousand represents our best estimate of the remainder expenses related to the ongoing clinical study which will be incurred after December 31, 2024 and until the end of the study. Share-Based Compensation We have several share-based compensation plans for employees and non-employees. We account for share-based compensation in accordance with the authoritative guidance on share-based compensation. Under the fair value recognition provisions of this guidance, share-based compensation is measured at the grant date based on the fair value of the award and is recognized as expense, net of estimated forfeitures, over the requisite service period, which is generally the vesting period of the respective award. Determining the fair value of the share-based payments at the grant date requires judgment. We calculated the fair value of stock options on the grant date using the Black-Scholes option pricing model. The Black-Scholes model requires the input of highly subjective assumptions, including the expected volatility, expected term, risk-free interest rate and dividend yield. Exercise price The exercise price of our stock options is based on the fair market value of our ordinary shares. Risk-free interest rate The risk-free interest rate is based on French government bonds (GFRN) with a maturity corresponding to the maturity of the share options. Expected term We determine the expected term based on the average period the stock options are expected to remain outstanding. Expected volatility We determine the expected volatility based on the historical data period corresponding to the stock options expected maturity. Expected dividend yield We have never declared or paid any cash dividends and we do not presently plan to pay cash dividends in the foreseeable future. Consequently, we use an expected dividend yield of zero. In the following table, the weighted average fair value of underlying shares are provided in euros, as we are incorporated in France and the euro is the currency used for the grants. We estimated the following assumptions for the calculation of the fair value of our stock options: Assumptions per year ended December 31, Stock options per grant date 2024 2023 Weighted average shares price at grant date in € 0.76 2.03 Weighted average expected volatility 90.61% 93.70% Weighted average risk-free interest rate 2.58% 2.95% Weighted average expected term (in years) 6.25 6 Dividend yield — — Weighted average fair value of stock-options in €* 0.57 1.67 * The weighted average fair value of underlying shares is presented in euros, as we are incorporated in France and the euro is the currency used for the grants. Pre-funded warrants The Company has assessed the pre-funded warrants for appropriate equity or liability classification. During this assessment, the Company determined the pre-funded warrants are freestanding instruments that do not meet the definition of a liability pursuant to ASC 480 and do not meet the definition of a derivative pursuant to ASC 815. The 2022 Warrants are classified as a component of permanent equity because they are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock with which they were issued, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permit the holders to receive a fixed number of shares of common stock upon exercise. In addition, the 2022 Warrants do not provide any guarantee of value or return. Accordingly, the pre-funded warrants are classified as equity and accounted for as a component of additional paid-in capital at the time of issuance. Smaller Reporting Company Status We are a smaller reporting company as defined in the Securities Exchange Act of 1934, as amended. We may, and intend to, take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as we are a smaller reporting company. We may be a smaller reporting company in any year in which (i) the market value of our voting and non-voting ordinary shares held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter or (ii) (a) our annual revenue is less than $100.0 million during the most recently completed fiscal year and (b) the market value of our voting and non-voting ordinary shares held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter. Off-Balance Sheet Arrangements We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC. Item 7A. Quantitative and Qualitative Disclosures About Market Risk. We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item. Item 8. Financial Statements and Supplementary Data. The financial statements required by this item are set forth beginning on page F-1 of this Annual Report on Form 10-K. Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. None.