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Item 7. Management’s Discussion and Analysis

2026-03-26 compared with 2025-04-11 · 198 added, 249 removed, 105 unchanged (81% of the section changed)

4 unchanged sentences

Please also see the section titled “Forward-Looking Statements.”

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 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.

4 unchanged sentences

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.

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.

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 .

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.

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.

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;

• 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:

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;

• 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.

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:

These leading international organizations perform, on behalf of the Company, all activities related to regulatory clinical trials once the study protocol has been finalized.

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.

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.

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.

Results of Operations

12 unchanged sentences

Loss before taxes (146,456) (113,863) (32,593) 29 %

Income tax (55) (7) (49) 721 %

Net loss (146,947) (113,918) (33,029) 29 %

3 unchanged sentences

2025 2024 $ change % of change

Sales — — — —

Other income 4,151 15,728 (11,577) (74) %

Research tax credit

1 unchanged sentence

Total Operating income 5,636 4,151 1,485 36 %

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.

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

4 unchanged sentences

Employee-related costs

Pre-Commercial Inventory

Share-based payment expenses

Depreciation and amortization (719) (13,658) 12,939 (95) %

Other costs 8,058 7,940 118 1 %

Depreciation, amortization and other costs

Total Research and Development expenses 116,682 89,342 27,341 31%

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

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.

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.

Viaskin Peanut (1)

As a percentage of research and development expenses, excluding share-based compensation Expense

Research and development expenses related to Viaskin Milk (1)

As a percentage of research and development expenses excluding share-based compensation Expense

Other research and development expenses (1)

Total research and development expenses, excluding share-based compensation expense

Share-based compensation expenses included in research and development expenses

Total research and development expenses 116,682

(1) Excludes employee share-based compensation expense

Sales and Marketing

The following table summarizes our sales and marketing expenses for the years presented:

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Total Sales & Marketing expenses 3,222 2,659 561 21 %

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

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:

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Total General & Administrative expenses 32,788 28,739 4,049 14 %

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)

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.

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)

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.

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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

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Net cash used for operating activities was $121.2 million and $104.5 million for the years ended December 31, 2025 and 2024, 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.,

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

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.

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

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

209.7 — — 209.7

Total 509.0 — — 509.0

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 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.

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.

Material expenses commitments

The following table presents our material expenses commitments for future periods:

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2026 2027 2028 Thereafter Total

(Amounts in thousands)

(Amounts in million)

Operating leases

Purchase obligations - Obligations Under the Terms of CRO Agreements

Purchase obligations - Obligations Under the Terms of CMO Agreements

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 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 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.

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.

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.

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

Total Amount available

2025 ATM Program

PFW1 from PFW-BS-PFW (2025 PIPE)

PFW2 (2025 PIPE)

13,116,331 0.12 1.6

Total 113,071,531 88.3

The table below summarizes our sources and uses of cash for the years ended December 31, 2025 and 2024.

(Amounts in thousands of U.S.

Dollars) 2024 2023 $ change % of change

2025 2024 $ change

Net cash flow used in operating activities

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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.

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

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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.

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

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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.

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.

• 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:

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.

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

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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.

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.

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.

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

Purchase obligations - Obligations Under the Terms of CMO Agreements

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.

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.

Quantitative and Qualitative Disclosures About Market Risk.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis