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 late-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 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. 2025 Year in review In 2025, the Company made significant progress advancing the VIASKIN Peanut patch toward commercialization (if approved), secured transformative financing, and identified regulatory pathways for our product candidates through discussions with and written responses from the FDA. As we enter 2026, our focus shifts toward commercialization and laying the groundwork to transform the lives of children living with peanut allergy. Since March 2025, we have increased cash and cash equivalents through our financing activities. We believe our cash and cash equivalents, (as of the date of this report as of December 31, 2025), are sufficient to pursue operations and prepare for the potential U.S. launch of the VIASKIN Peanut patch for children aged 4–7, if approved. The Company has proven our ability to perform under pressure and achieve key results, as seen in the announcement of the positive topline results of the VITESSE clinical study and successful financing. The Company’s goal is to broaden FDA-approved options for pediatric peanut allergy while delivering value to stakeholders. Financing March 2025 PIPE Financing The Company raised proceeds in 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 2024 General Meeting completed on April 7 2025, for an amount of €38 million ($40 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 ($85 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 gross proceeds of $125.5 million (€116.3 million) on April 7, 2025. On January 16, 2026, the Company announced additional gross proceeds of $195 million (€166.7 million at the exchange rate of 1 EUR = $1.17) resulting from the full exercise of the ABSA Warrants and BS Warrants, following the announcement of the positive VITESSE Topline Results on December 16, 2025. Of these proceeds, $100.7 million in gross proceeds (€85.7 million, at the exchange rate of 1 EUR = $1.17) was received as of December 31, 2025, with the remaining amount received in January 2026. The Accounting treatment is detailed into Note 1 Nature of the business and principles and accounting methods, Significant contracts . F - 70 At-The-Market (ATM) equity program offering In September 2025, the Company entered into a Sales Agreement (the “Sales Agreement”) with Citizens JMP Securities, LLC (“Citizens”), with respect to an equity offering program (the “ATM Offering”) pursuant to which the Company may offer and sell ADSs, from time to time, through Citizens as its sales agent. Pursuant to the Sales Agreement and a prospectus supplement the Company has filed related to the ATM Offering, the Company may offer and sell ADSs having an aggregate offering price of up to $150.0 million from time to time through Citizens. The issuance and sale, if any, of the ADSs by the Company under the Sales Agreement will be made pursuant to the Company’s previously filed and effective registration statement on Form S-3 (Registration Statement No. 333-271166). Sales of the Company’s ADSs, if any, in the ATM Offering may be made in sales deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act from time to time. Pursuant to the ATM Offering, the Company received (i) a total gross amount of $30 million from the sale of 11,538,460 Ordinary Shares (underlying 2,307,692 ADSs) on October 6, 2025, (ii) a total gross amount of $30 million from the sale of 10,714,300 Ordinary Shares (underlying 2,142,860 ADSs) on October 29, 2025, and (iii) a total gross amount of $5 million from the sale of 1,700,000 Ordinary Shares (underlying 340,000 ADSs) on November 19, 2025. 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. All assumptions pertaining to this estimate are detailed below in the Liquidity and Capital Resources discussion . Clinical & Regulatory On January 8, 2025, the Company announced positive 3-year results from EPITOPE Phase 3 Open-Label Extension Study, a Phase 3 clinical trial. The EPITOPE OLE data demonstrated continued improvement in treatment benefit of VIASKIN® Peanut patch in toddlers 1 – 3 years through 36 months. On March 24, 2025, the Company secured an agreement with FDA on Safety Exposure Data required for BLA for Viaskin® Peanut Patch in 4 – 7-year-olds, accelerating the timeline for a BLA filing to the first half of 2026. On June 25, 2025, the Company announced the first subject screened in COMFORT Toddlers Supplemental Safety Study in Peanut Allergic Toddlers 1 – 3 Years Old. On November 11, 2025, the Company announced the last‑patient‑last‑visit in the VITESSE Phase 3 clinical trial evaluating the VIASKIN® Peanut patch in peanut‑allergic children aged 4 to 7 years. On December 16, 2025, the Company announced positive Topline Results from Phase 3 VITESSE Trial of VIASKIN® Peanut Patch in Peanut Allergic Children Aged 4-7 Years. • VITESSE met its primary endpoint: the lower bound of the 95% confidence interval the difference between treatment arms was 24.5%, exceeding the prespecified threshold of 15%. • 46.6% of children treated with the VIASKIN® Peanut patch met response criteria at 12 months, compared to 14.8% of children in the placebo arm. • Safety results were consistent with the safety profile observed in the VIASKIN Peanut clinical program to date. • BLA submission in 4-7-year-olds on track for the first half of 2026. • Achievement of primary endpoint triggers an acceleration of the exercise period of certain warrants issued pursuant to the 2025 PIPE financing The clinical development history of the program is described into Item 1 Business: Our Viaskin Technology Platform of this document. Partnerships, Research & Developments. The Company relies on various subcontractors to conduct its operations, the principal categories of which include: • CROs: These leading international organizations perform, on behalf of the Company, all activities related to regulatory clinical trials once the study protocol has been finalized. • CMOs: As the Company does not currently hold the regulatory status of a pharmaceutical establishment, these entities manufacture the batches of patches required for preclinical and clinical development on the Company’s behalf. The Company’s dedicated partners also supply the proteins necessary for the manufacture of patches’batches, as well as various patch components and other materials required for production. A summary of these agreements is provided in Item 1 Business : Manufacturing and Supply of this document. Governance On July 22, 2025, the Company announced the appointment of James Briggs as Chief Human Resources Officer, succeeding Caroline Daniere. James Briggs leads key initiatives supporting DBV’s transition from a development‑stage biotechnology company to a potential commercial‑stage organization. On September 18, 2025, the Company announced the resignation of Daniel Soland from his position as a member of the Company’s Board of Directors, effective immediately. On October 30, 2025, the Company announced the provisional appointment of a new independent director, Dr. Philina Lee, to its Board of Directors, replacing Daniel Soland, subject to ratification by shareholders at DBV’s next annual shareholder meeting. Dr. Lee also serves as a member of the Board’s Compensation Committee. On November 3, 2025, the Company announced the appointment of Kevin Trapp as Chief Commercial Officer, responsible for the global commercial strategy and its execution for the Viaskin Peanut patch. F - 71 Results of Operations Comparison of the Years Ended December 31, 2025 and 2024 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, 2025 and 2024: December 31, 2025 2024 $ change % of change Operating income 5,636 4,151 1,485 36 % Operating expenses Research and development expenses (116,682) (89,342) (27,340) 31 % Sales and marketing expenses (3,222) (2,659) (562) 21 % General and administrative expenses (32,788) (28,739) (4,049) 14 % Total Operating expenses (152,692) (120,740) (31,952) 26 % Loss from operations (147,056) (116,589) (30,467) 26 % Financial income (expense) 601 2,726 (2,126) (78) % Loss before taxes (146,456) (113,863) (32,593) 29 % Income tax (491) (55) (436) 789 % Net loss (146,947) (113,918) (33,029) 29 % Basic/diluted Net loss per share attributable to shareholders (1.05) (1.17) — — Operating Income The following table summarizes our operating income for the years presented: December 31, 2025 2024 $ change % of change Research tax credit 5,636 4,146 1,489 36 % Other operating income — 5 (5) Total Operating income 5,636 4,151 1,485 36 % The Company did not generate Revenue from operating activities in 2025 or 2024. This caption consists of Research Tax Credit ( crédit d’impôt recherche , or CIR) that is granted to companies by the French tax authorities in order to encourage them to conduct technical and scientific researches. The Company was granted $5.6 million for the year ended December 31, 2025 compared to $4.2 million for the year ended December 31, 2024. The increase is the result of more eligible activities were carried out in the period. 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 The following table summarizes our research and development expenses for the years presented: December 31, 2025 2024 $ change % of change Research and Development expenses External clinical-related expenses 67,949 61,060 6,890 11% Employee-related costs 20,522 17,213 3,309 19% Pre-Commercial Inventory 16,062 1,388 14,674 1057% Share-based payment expenses 2,261 2,343 (82) (4)% Depreciation, amortization and other costs 9,889 7,338 2,551 35% Total Research and Development expenses 116,682 89,342 27,341 31% Research and Development expenses increased by $27.3 million for the year ended December 31, 2025 compared to the year ended December 31, 2024. The caption Pre-Commercial Inventory of $16.1 million reflects efforts launched by the company in inventory build-up to support commercial readiness in anticipation of potential FDA approval (written down as they do not meet recognition criteria). External clinical-related expenses increased by $6.9 million, due to higher clinical trial activity driven by the initiation of patient recruitment for COMFORT Toddlers study. These increases were partially offset by (1) reduced spending on the VITESSE study following completion of final patient visits in 2025 and (2) lower costs from other studies that are completed or nearing completion. F - 72 Employee-related costs, excluding share-based payments, increased by $3.3 million for the year ended December 31, 2025 compared to the year ended December 31, 2024 primarily driven by growth in full-time employees (“FTE”). This increase reflects the full-year impact in 2025 of hires made in 2024, combined with additional recruitments in 2025. These hires were mainly in Medical Affairs, Quality, and Regulatory functions, primarily based in the United States, and were made to support BLA submission and Commercial readiness activities. The increase also includes certain one-off costs related to the strong operational execution delivered in 2025. Depreciation, amortization and other costs increased by $2.6 million for the year ended December 31, 2025 compared to the year ended December 31, 2024, consequently to an accrual reversal related to CRO activities in the prior year, had a positive impact on the income statement and offsets the recurring depreciation and amortization. In the year ended December 31, 2025, we spent $116.7 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, 2025 and 2024, respectively: December 31, 2025 2024 Viaskin Peanut (1) 107,221 80,479 As a percentage of research and development expenses, excluding share-based compensation Expense 94 % 93 % Research and development expenses related to Viaskin Milk (1) 222 3,638 As a percentage of research and development expenses excluding share-based compensation Expense — % 4 % Other research and development expenses (1) 6,978 2,881 Total research and development expenses, excluding share-based compensation expense 114,421 86,999 Share-based compensation expenses included in research and development expenses 2,261 2,343 Total research and development expenses 116,682 89,343 (1) Excludes employee share-based compensation expense 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. The following table summarizes our sales and marketing expenses for the years presented: December 31, 2025 2024 $ change % of change Sales & Marketing expenses External professional services and other costs 1,967 1,770 197 11 % Employee-related costs incl. share-based payment expenses 1,254 890 364 41 % Total Sales & Marketing expenses 3,222 2,659 561 21 % Sales and marketing expenses increased by $0.6 million for the year ended December 31, 2025 compared to the year ended December 31, 2024. This increase was primarily attributable to the expansion of headcount and market research activities to support commercial readiness for Viaskin Peanut in North America. General and Administrative The following table summarizes our general and administrative expenses for the years presented: December 31, 2025 2024 $ change % of change General & Administrative expenses External professional services 9,072 10,052 (980) (10) % Employee-related costs 12,972 8,981 3,991 44 % Share-based payment expenses 3,012 2,161 851 39 % Depreciation, amortization and other costs 7,731 7,545 186 2 % Total General & Administrative expenses 32,788 28,739 4,049 14 % General and administrative expenses increased by $4.0 million for the year ended December 31, 2025, compared to the year ended December 31, 2024. The increase was primarily driven by higher employee‑related costs (excluding share‑based compensation), which rose by $4.0 million as the Company continued to scale its organization in preparation for commercial operations. The growth in full‑time employees was concentrated in Human Resources, Information Solutions, Finance, and Legal and Compliance, reflecting targeted investments in the core infrastructure required to achieve commercial readiness for Viaskin Peanut in North America. These additions were designed to strengthen operational capabilities, enhance organizational maturity, and support the transition toward a potential commercial launch, if approved. F - 73 The increase also reflects certain one‑off costs associated with the strong operational execution delivered in 2025, including preparatory initiatives tied to commercial planning and organizational enablement. These increases were partially offset by a $(1.0) million decrease in external professional services, primarily due to the absence of prior‑year one‑time expenses related to office relocations in France and the United States, as well as reduced trademark and patent‑related activities. 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. Our financial income was $0.6 million in 2025 and $2.7 million in 2024, and primarily includes the financial income on our financial assets and foreign exchange gains. Income tax Our income tax expense was $491 thousand for the year ended December 31, 2025, compared to an income tax expense of $55 thousand for the year ended December 31, 2024. Net loss Net loss was $146.9 million for the year ended December 31, 2025, compared to $113.9 million for the year ended December 31, 2024. Net loss per share (based on the weighted average number of shares outstanding over the period) was $1.05 and $1.17 for the year ended December 31, 2025 and 2024, respectively. Liquidity and Capital Resources Our financing strategy is to maintain financial flexibility to meet working capital requirements including commercial inventory build and manufacturing capacity expansion to support demand of VIASKIN Peanut patches in the United States and Europe, if approved. Financial Condition On December 31, 2025, we held $194.2 million in cash and cash equivalents compared to $32.5 million of cash and cash equivalents on December 31, 2024. Net cash used for operating activities was $121.2 million and $104.5 million for the years ended December 31, 2025 and 2024, respectively. In the year ending December 31, 2025, we recorded a net loss of $146.9 million. Our net cash flows provided by financing activities totaled $276.2 million in 2025 and $0.6 million in 2024, mainly consisting of the proceeds from the 2025 PIPE and sales from our ATM program. Sources of Liquidity and Material Cash Requirements Since its inception and up to December 31, 2025, the Company has received a total of approximately $1.6 billion in equity financing, almost all of which relates to cash proceeds from capital increases. The Company obtained the following gross proceeds from various financings through the issuance of securities during the last five years : In Million dollars Equity capital Bank loan Other debt Total 2022 209.7 — — 209.7 2023 7.8 — — 7.8 2024 — — — 2025 291.5 291.5 Total 509.0 — — 509.0 In June 2022, the Company announced an aggregate $194 million private investment in public equity (“PIPE”) financing from the sale of 32,855,669 ordinary shares, as well as pre-funded warrants to purchase up to 28,276,331 ordinary shares. The ordinary shares were sold to the purchasers at a price per ordinary share of €3.00 (corresponding to $3.22), and the pre-funded warrants at a pre-funded price of €2.90 (corresponding to $3.11) per pre-funded warrant, which equals the per share price for the ordinary shares less the remaining €0.10 exercise price for each such pre-funded warrant. In April 2025, the Company completed a PIPE financing generating initial gross proceeds of $125.5 million (€116.3 million), followed by the full exercise of associated warrants in January 2026 after the announcement of positive Phase 3 VITESSE topline results, resulting in additional gross proceeds of $195.2 million (€166.7 million at 1 EUR = $1.17). The gross proceeds received subsequently of $94.2 million (€80.8 million at 1 EUR = $1.17) are not included in the table above. In addition, in September 2025, the Company established an ATM equity program pursuant to which it may offer and sell up to $150.0 million of ADSs, subject to applicable regulatory limits. During the fourth quarter of 2025, the Company raised $65 million in gross proceeds through multiple issuances of ADSs. The Company also benefits as an SME status from refunds of Research Tax credit ( crédit d’impôt recherche ) granted to companies by the French tax authorities in order to encourage them to conduct technical and scientific research. F - 74 Material expenses commitments The following table presents our material expenses commitments for future periods: Material Cash Requirements Due by the Year Ended December 31, 2026 2027 2028 Thereafter Total (Amounts in million) Operating leases 0.8 1.2 1.2 5.1 8.4 Purchase obligations - Obligations Under the Terms of CRO Agreements 26.6 22.0 22.1 19.1 89.8 Purchase obligations - Obligations Under the Terms of CMO Agreements 17.4 15.6 15.7 — 48.7 Total 44.8 38.9 39.0 24.2 147.0 The commitment amounts in the table above are associated with contracts that are enforceable and legally binding and that specify all significant terms, including 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. Forward-looking As a result of the proceeds received from the subsequent exercise of the ABSA and BS warrants of $94 million (€81 million) and with existing cash and cash equivalents as of December 31, 2025 of $194 million, management has determined that the Company has sufficient liquidity to fund its operations for at least twelve months from the date of issuance of this Form 10‑K and that the conditions that previously raised substantial doubt about the Company’s ability to continue as a going concern are no longer present. With the receipt of the aforementioned proceeds, and based on its current operations, plans, and assumptions, the Company estimates that its cash and cash equivalents are sufficient to fund its operations into the second quarter of 2027. These estimates are based on the Company’s current forecasts and exclude any additional expenditures related to other programs than the VIASKIN Peanut or resulting from the potential in licensing or acquisition of additional product candidates or technologies, or any associated development the Company may pursue. The Company may have based these estimates on assumptions that are incorrect, and the Company may end up using its resources sooner than anticipated. The Company may expend resources sooner than anticipated and may seek additional resources to execute the corporate strategy either through new or existing financing strategies. As of date of issuance, the remaining financing capacity and Equity securities are: Remaining financing capacity and Equity securities Warrants Strike price Total Amount available 2025 ATM Program 85.0 PFW1 from PFW-BS-PFW (2025 PIPE) 32,267,060 0.01 0.3 PFW2 (2025 PIPE) 67,688,140 0.02 1.4 PFW 2022 13,116,331 0.12 1.6 Total 113,071,531 88.3 Cash flows The table below summarizes our sources and uses of cash for the years ended December 31, 2025 and 2024. December 31, (Amounts in thousands of U.S. Dollars) 2025 2024 $ change Net cash flow used in operating activities (121,181) (104,474) (16,707) Net cash flow used in investing activities (1,369) (757.3) (612.016) Net cash flow provided by financing activities 276,182 587 275,596 Effect of exchange rate changes on cash and cash equivalents 8,080 (4,268) 12,348 Net (decrease) increase in cash and cash equivalents 161,711 (108,913) 270,624 F - 75 Operating Activities Our net cash flows used in operating activities were $121.2 million and $104.5 million for the years ended December 31, 2025 and 2024 respectively. Our net cash flows used in operating activities increased by $16.7 million or 16%. The variance was primarily attributable to higher operating expenditures, including (1) expenses related to inventory (not capitalized) build-up to support commercial readiness, (2) increase in external clinical-related expenses driven by the initiation of patient recruitment for COMFORT Toddlers study and significant clinical milestone payments for VITESSE Study through the achievement of positive Topline results, and (3) higher personnel-related costs reflecting the full-year impact in 2025 of hires made in 2024, combined with additional hires in 2025 to support the BLA submission and commercial readiness, as well as certain non-recurring costs. Investing Activities Our net cash flows used in investing activities were $1.4 million in 2025 and $0.8 million in 2024. Financing Activities Our net cash flows resulting from financing activities was $276.2 million in 2025 compared to $0.6 million in 2024 resulting from successful financing operations completed by the company throughout the period as listed above in the section entitled Financing of 2025 Year in review . 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 in Note 1 to our financial statements for a description of our other significant accounting policies. March 2025 PIPE Financing The accounting for the Company’s pre‑funded warrants issued in April 2025 involves significant judgment and represents a critical accounting estimate, as it requires management to determine whether the instruments should be classified as equity or liabilities, which could materially affect the Company’s financial position and results of operations. Management evaluated the pre‑funded warrants under ASC 480, Distinguishing Liabilities from Equity, and ASC 815, Derivatives and Hedging, including the guidance in ASC 815‑40, Contracts in Entity’s Own Equity. This assessment required judgment in evaluating the contractual terms, settlement provisions and potential contingencies of the instruments. The Company concluded that the pre‑funded warrants do not meet the criteria for liability classification under ASC 480, as they are freestanding, provide for a fixed number of shares upon exercise, and do not obligate the Company to transfer cash or repurchase shares. In addition, management determined that the warrants are indexed to the Company’s ordinary shares and qualify for equity classification under ASC 815‑40, as they require physical settlement in shares, do not provide for net‑cash settlement, and do not include cash‑settled make‑whole or similar provisions. The Company has sufficient authorized and unissued shares available to settle the warrants. Accordingly, the pre‑funded warrants are classified in permanent equity and are not remeasured at fair value after initial recognition. Subsequent changes in fair value are not recognized in earnings as long as the warrants continue to qualify for equity classification. Upon exercise of the pre‑funded warrants, the Company records the par value of the issued shares in common stock, and the remaining amount recorded in additional paid‑in capital. No gain or loss is recognized upon exercise. Share base payments The Company maintains several share‑based compensation plans for employees and non‑employees. The accounting for share‑based compensation represents a critical accounting estimate due to the significant judgment required to determine the fair value of equity awards at the grant date and the potential impact of changes in key assumptions on compensation expense and operating results. Equity awards are measured at grant‑date fair value and recognized as compensation expense, net of estimated forfeitures, over the requisite service period, which generally corresponds to the vesting period of the respective awards. Valuation methodology and key assumptions The fair value of stock options is estimated at the grant date using the Black‑Scholes option pricing model, which requires management to make a number of highly subjective assumptions, including expected volatility, expected term, risk‑free interest rate and expected dividend yield. These assumptions are inherently uncertain and require significant judgment. • Exercise price of stock options is based on the fair market value of the Company’s ordinary shares at the grant date. • Risk‑free interest rate is determined using French government bonds (GFRN) with a maturity corresponding to the expected term of the stock options. • Expected term represents the period over which stock options are expected to remain outstanding and is determined based on the average expected life of the options, taking into account vesting conditions and historical exercise behavior. F - 76 • Expected volatility is determined based on historical share price data over a period consistent with the expected maturity of the stock options. Given the Company’s exposure to factors such as clinical development progress, regulatory outcomes, financing activities and broader biotechnology market conditions, estimating future volatility involves a high degree of judgment. • Expected dividend yield: The Company has never declared or paid cash dividends and does not currently intend to pay cash dividends in the foreseeable future. Accordingly, an expected dividend yield of zero is used in the valuation of stock options. Sensitivity and impact on results of operations Changes in the assumptions used to estimate the fair value of share‑based awards could materially affect compensation expense. In particular, increases in expected volatility or expected term would generally result in a higher fair value of stock options and higher share‑based compensation expense, while decreases in these assumptions would have the opposite effect. Share‑based compensation expense is recognized primarily within research and development expenses and general and administrative expenses and therefore directly impacts the Company’s operating loss. In addition, equity awards may result in future dilution to existing shareholders upon vesting and exercise. Management reviews the assumptions used in valuing share‑based awards on a regular basis and updates them as necessary based on available information. However, because these estimates depend on future events and market conditions, actual results may differ materially from management’s estimates. 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 In connection with the launch of our clinical trials , we signed agreements with several CROs. As of December 31, 2025, expenses associated with the ongoing trials amounted globally to $32.7 million, and we had non-cancellable contractual obligations with CRO until the year ended 2027 amounting to $48.6 million. The Company has entered into multi‑year supply and manufacturing agreements that include minimum purchase obligations over defined periods. Under applicable accounting guidance, take‑or‑pay commitments are generally considered firm purchase commitments but remain off‑balance sheet unless they create an unavoidable or unconditional payment obligation, or become loss contracts. With Sanofi On August 29, 2025, the Company entered into the Supply Agreement with SANOFI, under which SANOFI will manufacture and supply the Viaskin Peanut API for the Company. Under the Supply Agreement, the Company has agreed to certain minimum purchase levels and service fees over the initial 4-year-term. As of December 31, 2025, total payments made during the period under the Supply Agreement are approximately $8.6M, which were recorded as R&D expenses. The Company will expense manufacturing and supply costs as incurred. With Fareva On March 17, 2026, DBV Technologies S.A. entered into a new Manufacturing and Supply Agreement (the “MS Agreement”) with FAREVA La Vallée (“FLV”), under which the FLV will manufacture and supply the Viaskin Peanut Source Material (“PSM”), exclusively for DBV Technologies S.A. during the agreement term. The term is effective for a period of eight (8) years and can be renewed for a period of two (2) years . As of December 31, 2025, total payments made during the year under the MS Agreement and the SBC Agreement are approximately $1.4 million, which were recorded as detailed in Note 1 Nature of the business and principles and accounting methods, Significant contracts . The following table presents our material expenses commitments for future periods: 2026 2027 2028 Thereafter Total (Amounts in million) Purchase obligations - Obligations Under the Terms of CRO Agreements 26.6 22.0 22.1 19.1 89.8 Purchase obligations - Obligations Under the Terms of CMO Agreements 17.4 15.6 15.7 — 48.7 Total 44.0 37.6 37.8 19.1 138.5 Letter of Credit and Collateral A Certificate of Deposit, for an initial amount of $0.3 million was signed in order to guarantee an American Express credit cards program in the United States. F - 77 Subsequent Events March 2025 PIPE Financing - January 16, 2026 The Company has received the supplemental gross proceeds of $94 million (€81 million) resulting in the full exercise of the ABSA Warrants and BS Warrants issued on its March 2025 PIPE financing. Additional Data from Successful Phase 3 VITESSE Study - February 28, 2026 The Company highlighted additional data from successful Phase 3 VITESSE Study at the AAAAI 2026 Annual Meeting • Approximately 83% of children treated with the VIASKIN® Peanut Patch increased their eliciting dose at month 12, compared to approximately 48% in the placebo group; • Approximately 60% of children treated with the VIASKIN® Peanut Patch increased their eliciting dose by at least two doses at month 12, compared to 23% in the placebo group; • 24% of children on placebo decreased their eliciting dose between the baseline and month 12 double-blind, placebo-controlled food challenge, compared to only 6.4% of children treated with the VIASKIN® Peanut Patch. Manufacturing Supply Agreement - PSM “Peanut Source Material “ Fareva La Vallée - March 17, 2026 The Company entered into the MS Agreement with FLV, under which the CMO will manufacture and supply PSM, exclusively for DBV Technologies S.A. during the agreement term. The term is effective for a period of eight (8) years and can be renewed for a period of two (2) years. F - 78 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.