DBV Technologies SA

Notes to the Consolidated Financial Statements

Note 1 Nature of the business and principles and accounting methods

Incorporated in 2002 under the laws of France, DBV Technologies S.A. (“DBV Technologies,” or the “Company”, or “we”, or the “group”) is a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin™. The Company’s therapeutic approach is based on epicutaneous immunotherapy, or EPITTM, a proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin™.

Basis of Presentation

The Company’s consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the U.S. (“U.S. GAAP”) and presented in thousands of U.S. Dollars, except for share and per share data and as otherwise noted. Any reference in these notes to applicable guidance is meant to refer to authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). We also follow the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). The Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern and using the historical cost principle with the exception of certain assets and liabilities that are measured at fair value in accordance with U.S. GAAP. The categories concerned are detailed in the following notes.

Principles of Consolidation

The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. Intercompany transactions and balances have been eliminated.

The following list presents all entities included in the consolidation scope for the years ended December 31, 2023 and 2024, as well as their country of incorporation and the percentage of ownership interests:

•DBV Technologies Inc. was incorporated in Delaware on April 7, 2014 (the “US subsidiary”). The share capital of this US subsidiary is 100% owned by DBV Technologies S.A.;

•DBV Australia Pty Ltd. was incorporated in New South Wales, Australia on July 3, 2018 (the “Australian subsidiary”). The share capital of this Australian subsidiary is 100% owned by DBV Technologies S.A. (“DBV Technologies”);

•DBV Pharma was incorporated in Paris on December 31, 2018 (the “French subsidiary”). The share capital of this French subsidiary is 100% owned by DBV Technologies S.A.

Functional Currency and Translation of Financial Statements in Foreign Currency

The Consolidated Financial Statements are presented in U.S. dollars, which differs from the functional currency of the Company, being the Euro. The statements of financial position of consolidated entities having a functional currency different from the presentation currency are translated at the closing exchange rate (spot exchange rate at the statement of financial position date) and the statements of operations, statements of comprehensive loss and statements of cash flow of such consolidated entities are translated at the weighted average exchange rate. The resulting translation adjustments are included in equity under the caption “Accumulated other comprehensive income (loss)” in the Consolidated Statements of Changes in Shareholders’ Equity.

Conversion of Foreign Currency Transactions

Foreign currency transactions are converted to functional currency of the entity at the rate of exchange applicable on the transaction date. At period-end, foreign currency monetary assets and liabilities are converted at the rate of exchange prevailing on that date. The resulting exchange gains or losses are recorded in the Consolidated Statement of Operations and Comprehensive Loss in Operating income (expenses) or Financial income (expenses) depending on the nature of the underlying monetary item.

Use of estimates

The preparation of the Company’s consolidated financial statements requires the use of estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, and disclosures of contingent assets and liabilities at the date of the consolidated financial statements and the reported amount of income and expenses during the period. The Company bases its estimates and assumptions on historical experience and other factors that it believes to be reasonable under the circumstances.

On an on-going basis, management evaluates its estimates, primarily those related to: (1) evaluation of costs and measure of progress of the wind-down activities resulting from the termination of the collaboration agreement with Nestlé Health Science, (2) research tax credits, (3) assumptions used in the valuation of right-of-use assets—operating lease, (4) impairment of right-of-use assets related to leases and property, plant and equipment, (5) recoverability of the Company’s net deferred tax assets and related valuation allowance, (6) assumptions used in the valuation model to determine the fair value and vesting conditions of share-based compensation plan, and (7) estimate of provisions and contingencies.

Going concern

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These 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.

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.

Intangible Assets

Acquired intangible assets are accounted for at acquisition cost less accumulated amortization. Acquired intangible assets are mainly composed of software amortized on a straight-line basis over their estimated useful lives comprised betweenone andthree years. Intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The costs related to the acquisition of licenses to software are posted to assets on the basis of the costs incurred to acquire and to implement the software.

Property, Plant, and Equipment

Property, plant, and equipment are recorded at their acquisition cost.

Property, plant, and equipment are depreciated on a straight-line method over the estimated useful lives of the property. Leasehold improvements are amortized over the shorter of the estimated useful lives of the assets or the remaining lease term.

Depreciation is calculated on a straight-line basis over the assets’ estimated useful lives as follows:

Impairment of assets

The Company periodically reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable or the estimated useful life is no longer appropriate. If indicators of impairment exist and the recoverable value of the asset on an undiscounted cash flow basis is less than the carrying amount, an impairment loss is recorded to the extent the carrying amount exceeds its fair value.

Lease contracts

The Company determines whether an arrangement is a lease at contract inception by establishing if the contract conveys the right to use, or control the use of, identified property, plant, or equipment for a period of time in exchange for consideration. The Company’s leases are comprised of real estate leases, leases for industrial equipment and leases for office equipment.

The Company’s real estate leases typically include options and features including rent free periods, rent escalation periods, renewal options and early termination options. The lease term is defined contract-by-contract and corresponds to the non-cancelable period of the lease taking into account the optional periods that are reasonably certain to be exercised.

The Company recognizes operating lease liabilities based on the present value of the future minimum lease payments over the lease term at commencement date.

The Company does not recognize a lease liability or right of use asset for leases with a term of 12 months or less. Operating lease right of use assets are presented as operating lease right of use assets on the consolidated balance sheet. To date, the Company has recognized a single lease cost under which the operating lease right of use and liability are amortized on a straight-line basis over the lease term, and categorized within Operating Expense in the Consolidated Statement of Operations. The operating lease cash flows are categorized under Net Cash Used in Operating Activities in the Consolidated Statement of Cash Flows. Variable costs are expensed in the period incurred.

Since the rate implicit in the lease is not readily determinable, the Company uses its incremental borrowing rates based on the information available at commencement date in determining the discount rate used to calculate the present value of lease payments. As the Company has no external borrowings, the incremental borrowing rates are determined using information on indicative borrowing rates that would be available to the Company based on the value, currency and borrowing term provided by financial institutions, adjusted for company and market specific factors.

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Inventories and Work in Progress

Inventories are measured at the lower of cost or net realizable value at production costs calculated using the first-in, first-out method. It includes acquisition costs, processing costs and other costs incurred in bringing the inventories to their present location and condition.

Inventories are exclusively composed of work in progress relating to the production of the first batches that may be used for the commercialization.

During the launch phase of a new product, any inventories of that product are written down to zero pending regulatory approval.

Financial Assets and Liabilities

Financial assets, excluding cash and cash equivalents, consist exclusively of other receivables. Other receivables are non-derivative financial assets with a payment, which is fixed or can be determined, not listed on an active market. They are included in current assets, except those that mature more than twelve months after the reporting date. The recoverable amount of other receivables is estimated whenever there is an indication that the asset may be impaired and at least on each reporting date. If the recoverable amount is lower than the carrying amount, an impairment loss is recognized in the Consolidated Statements of Operations and Comprehensive Loss.

The Company also receives from time-to-time assistance in the form of conditional advances, which are advances repayable in whole or in part based upon acknowledgment by the funder of a technical or commercial success of the related project by the funding entity.

The amount resulting from the deemed benefit of the interest-free nature of the award is considered a subsidy for accounting purposes. This deemed benefit is determined by applying a discount rate equal to the rate of fungible treasury bonds over the time period that corresponds to the time period of the repayment of the advances.

In the event of a change in payment schedule of the stipulated repayments of the conditional advances, the Company makes a new calculation of the net book value of the debt resulting from the discounting of the expected new future cash flows. The adjustment that results therefrom is recognized in the income statement for the fiscal year during which the modification is recognized.

The Company carries its trade receivable at net realizable value. On a periodic basis, the Company evaluates its trade receivable and determines whether to provide an allowance or if any accounts should be written down and charged to expense as a bad debt. The Company generally does not require any security or collateral to support its receivables.

During the years ended December 31, 2024 and December 31, 2023, the Company didnot hold any derivative financial instruments.

Fair Value Measurements

Fair value is defined as an exit price, representing the amount that would be received upon the sale of an asset or payment to transfer a liability in an orderly transaction between market participants. Fair value is a market-based measurement that is determined based on assumptions that market participants would use in pricing an asset or liability. A three-tier fair value hierarchy is used to prioritize the inputs in measuring fair value as follows:

•Level 1—Quoted market prices (unadjusted) in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date;

•Level 2—Quoted market prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable, either directly or indirectly. Fair value determined through the use of models or other valuation methodologies;

•Level 3—Significant unobservable inputs for assets or liabilities that cannot be corroborated by market data. Fair value is determined by the reporting entity’s own assumptions utilizing the best information available and includes situations where there is little market activity for the asset or liability.

The asset’s or liability’s fair value measurement within the fair value hierarchy is based upon the lowest level of any input that is significant to the fair value measurement. The Company’s policy is to recognize transfers between levels of the fair value hierarchy in the period the event or change in circumstances that caused the transfer. There were no transfers into or out of Level 1, 2, or 3 during the periods presented.

The Company considers its cash and cash equivalents, accounts receivable and accounts payable to reflect their fair value given their short maturity and risk profile of the counterparty.

Cash and Cash Equivalents

Cash includes cash on hand and demand deposits with banks. Cash equivalents include short-term, highly liquid investments, with a short term remaining maturity at the date of purchase or less, readily convertible to known amounts of cash, for which the risk of changes in value is considered to be insignificant. Demand deposits therefore meet the definition of cash equivalents. Cash equivalents are measured at fair value using Level 1 and any changes are recognized in the Consolidated Statements of Operations and Comprehensive Loss.

Concentration of Credit Risk

The Company has no significant off-balance sheet risk, such as foreign currency contracts, options contracts, or other foreign hedging arrangements. Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and other receivables. Periodically, the Company maintains deposits in accredited financial institutions in excess of federally insured limits. The Company deposits its cash in financial institutions that it believes have high credit quality and have not experienced any losses on such accounts and does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships or entities for which it has a receivable.

Share Capital

Ordinary shares are classified under Shareholders’ Equity. The costs of share capital transactions that are directly attributable to the issue of new shares or options are recorded in the Consolidated Financial Statements in Shareholders’ Equity as a deduction from the proceeds from the issue, net of tax.

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Employee benefits

Depending on the laws and practices of the countries in which the Company operates, employees may be entitled to compensation when they retire or to a pension following their retirement. For state-managed plans and other defined contribution plans, the Company recognizes them as expenses when they become payable, with the Company’s commitment being limited to our contributions.

The liability with respect to defined benefit plans is estimated using the following main assumptions:

•discount rate;

•future salary increases;

•employee turnover; and

•mortality tables.

The difference between the amount of the liability at the beginning of a fiscal year and at the close of that year is recognized through profit or loss for the portion representing the costs of services rendered and through other comprehensive income (loss) for the portion representing the actuarial gains and losses. Service costs are recognized in profit or loss and are allocated by function.

Actuarial gains and losses result from changes in actuarial assumptions and from differences between assumed and actual experience. Gains and losses recorded in other comprehensive income (loss) are amortized over expected remaining service periods to the extent they exceed 10% of the projected benefit obligation for the defined benefit plan.

The Company’s payments for the defined-contribution plans are recognized as expenses in the Consolidated Statements of Operations and Comprehensive Loss for the period with which they are associated.

Contingencies

An estimated loss from a loss contingency is recognized if the following two conditions are met:

•information available before the consolidated financial statements are issued indicates that it is probable that an asset had been impaired or a liability had been incurred at the date of the consolidated financial statements; and

•the amount of loss can be reasonably estimated.

With respect to litigations and claims that may result in a liability to be recognized, we exercise significant judgment in measuring and recognizing a liability or determining exposure to contingent liabilities that are related to pending litigation or other outstanding claims. These judgment and estimates are subject to change as new information becomes available.

The Company accounts for revenue when the amount can be reliably assessed, future economic benefits are likely to benefit the Company, and specific criteria are met for the Company’s business, which is in accordance with ASC 606 for the collaboration agreement with Nestlé Health Science.

Other operating income

Research Tax Credit

The research tax credit (crédit d’impôt recherche) 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 against the payment of the income 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.

In the fiscal year ended December 31, 2021, the Company recovered its Small and Medium-sized Enterprises, or SMEs, status under EU law, and became therefore eligible again for the immediate reimbursement of the Research Tax Credit. During the year ended December 31, 2023, the Company received a reimbursement of $6.0 million for the 2022 fiscal year Research Tax Credit.. During the year ended December 31, 2024, the Company received a reimbursement for the 2023 fiscal year Research Tax Credit. for a total amount of $8.7 million, included 2020, 2021 and 2022 complementary Research Tax Credit. made during the fiscal year ended December 31, 2023.

Collaboration agreement with Nestlé Health Science

The Company entered into research and development collaboration agreements that may consist of non-refundable upfront payments and milestone payments.

Non-refundable upfront payments are deferred and recognized as income over the period of the collaboration agreement.

Milestone payments represent amounts received depending upon the achievement of certain scientific, regulatory, or commercial milestones. They are recognized when the triggering event has occurred, there are no further contingencies or services to be provided with respect to that event, and the co-contracting party has no right to require refund of payment. The triggering event may be scientific results achieved by the Company or another party to the arrangement, regulatory approvals, or the marketing of products developed under the arrangement.

Until the Termination letter agreement signed on October 30, 2023, the Company recognized income under the percentage-of-completion method, using costs incurred as the input method to determine progress towards the achievement of each milestone, and recognizing revenue based on costs incurred to date plus the estimate of margin at completion of the milestone. The Company periodically updated its measurement of progress and updated its cumulative income recognized accordingly. The Company accrued for any excess between costs yet to be incurred and income yet to be recognized for the completion of the performance obligations. Please refer to Note 13 “Contingencies”.

Research and Development Expenditures

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Research and development expenditures are charged to expense as costs are incurred in performing research and development activities. Research and development costs include all direct costs, including salaries, share-based payments and benefits for research and development personnel, outside consultants, costs of clinical trials, costs related to manufacturing clinical study materials, sponsored research, clinical trials insurance, other outside costs, depreciation, 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, and the expenses related to these activities are included in research and development costs. 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. Please refer to Collaboration agreement with Nestlé Health Science for further detail.

Share-based payments

Since its incorporation, the Company has established several plans for equity compensation issued in the form of employee warrants (bons de souscription de parts de créateur d’entreprise or “BCEs”), stock options (“SO”), and restricted stock units (“RSUs”) granted to employees and/or executives. The company has also established several plans for equity compensation issued in the form of “share warrants” (bons de souscription d’actions or “BSAs”) granted to non-employee members of the Board of Directors and members of the Scientific Advisory Board.

These awards are measured at their fair value on the date of grant. Except for RSUs, fair value is estimated using Black and Scholes models that require inputs based on certain subjective assumptions, including the expected term of the award, and the conditions of each equity plan. The fair value is amortized in personnel expenses (allocated by function in the Consolidated Statements of Operations and Comprehensive Loss) on a straight-line basis over the requisite service period, and such expense is reduced for estimated forfeitures, with a corresponding increase in shareholders’ equity.

The determination of the requisite service period and the estimate of RSUs awards that are expected to vest depends on the legal interpretation of the RSUs award agreements with employees under the French labor laws and related jurisprudence. Changes in interpretations could significantly impact the accounting for the share-based payments.

At each closing date, the Company re-assesses the number of options expected to vest. If applicable, the impacts of such revised estimates are recognized in the Consolidated Statements of Operations and Comprehensive Loss, with a corresponding adjustment in shareholders’ equity.

The awards are not subject to any market conditions.

Income Tax

Income taxes are accounted for under the asset and liability method of accounting. Deferred taxes are recognized for the future tax consequences attributable to temporary differences between the financial reporting carrying amounts and tax bases of assets and liabilities, and on tax losses, using the liability method. Differences are defined as temporary when they are expected to reverse within a foreseeable future. The Company may only recognize deferred tax assets on net operating losses if, based on the projected taxable incomes within the next three years, management determines that it is probable that future taxable profit will be available against which the unused tax losses and tax credits can be utilized. As a result, the measurement of deferred income tax assets is reduced, if necessary, by a valuation allowance for any tax benefits which are not expected to be realized. If future taxable profits are considerably different from those forecasted that support recording deferred tax assets, the Company will have to revise downwards or upwards the amount of deferred tax assets, which would have a significant impact on the Company’s financial results. Tax assets and liabilities are not discounted. Amounts recognized in the Consolidated Financial Statements are calculated at the level of each tax entity included in the consolidation scope. Deferred tax assets and liabilities are measured using the enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes are enacted.

Uncertain tax position

Tax benefits are recognized from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities based on the technical merits of the position.

Segment Information

The Company operates in a single operating segment: the conducting of research and development of epicutaneous immunotherapy products in order to market them in the future. The assets, liabilities, and operating losses recognized are primarily located in France.

Other Items in the Comprehensive Loss

Comprehensive loss is comprised of net income (loss) and other comprehensive income (loss). Other comprehensive income (loss) includes changes in equity that are excluded from net income (loss), such as foreign currency translation adjustments. These changes in equity are presented net of tax.

Net Loss Per Share

The Company calculates basic and diluted net loss per ordinary share by dividing the net loss by the weighted-average number of ordinary shares outstanding during the period. For the years ended December 31, 2024 and 2023, the Company has excluded the effects of all potentially dilutive shares, which include outstanding ordinary stock options, warrants to purchase ordinary shares, and restricted stock units, from the weighted-average number of ordinary shares outstanding as their inclusion in the computation for these years would be anti-dilutive due to net losses incurred.

Subsequent Events

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The Consolidated Statements of Financial Position and the Consolidated Statements of Operations and Comprehensive Loss of the Company are adjusted to reflect the subsequent events that alter the amounts related to the situations that existed as of the end of the period covered. The Company has evaluated subsequent events from the balance sheet date through April 11, 2025, the date at which the consolidated financial statements are issued.

Accounting Pronouncements adopted in 2024

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280) — Improvements to Reportable Segment Disclosures, which enables investors to better understand an entity's overall performance and assists with assessing potential future cash flows. ASU 2023-07 expands public entities’ segment disclosures by requiring disclosure of significant segment expenses that are regularly provided to the Chief Operating Decision Maker (CODM) and included in the reported measure of segment profit and loss. The Company adopted ASU 2023-07 in December 2024. Refer to Note 21 - Reportable Segment Disclosure for further information.

Accounting Pronouncements issued not yet adopted

In December 2023, the FASB issued ASU 2023-09, Income Taxes Topic 740 — Improvements to Income Tax Disclosures which enhances the transparency and usefulness of income tax disclosures. This amendment requires disclosure of disaggregated information about the Company’s effective tax rate reconciliation as well as information on income taxes paid. The disclosure requirements will be applied on a prospective basis, with the option to apply it retrospectively. For SEC filers, this ASU is effective for fiscal years beginning after December 15, 2024. The Company is currently evaluating the impact the adoption of this ASU will have on its consolidated financial statements and related disclosures.

In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income Topic 220 — Expense Disaggregation Disclosures. The guidance requires disclosure of additional information about specific expense categories in the notes to financial statements at interim and annual reporting periods. The disclosure requirements will be applied on a prospective basis, with the option to apply it retrospectively. For SEC filers, this ASU is effective for fiscal years beginning after December 15, 2026 and interim periods within fiscal years beginning after December 15, 2027. The Company is currently evaluating the impact the adoption of this ASU will have on its consolidated financial statements and related disclosures.

Other accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on the Company’s Consolidated Financial Statements upon adoption.

Note 2 Significant Events and Transactions of the Periods

Clinical programs

United States Regulatory History and Current Status

In January 2021, the Company received written responses from the FDA to questions provided in the Type A meeting request the Company submitted in October 2020 following the CRL. The FDA agreed with its position that a modified Viaskin Peanut patch should not be considered as a new product entity provided the occlusion chamber of the current Viaskin Peanut patch and the peanut protein dose of 250 μg (approximately 1/1,000 of one peanut) remains unchanged and performs in the same way it has performed previously. In order to confirm the consistency of efficacy data between the existing and a modified patch, FDA requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4-11. The Company named that assessment EQUAL, which stands for Equivalence in Uptake of Allergen. The FDA also recommended conducting asix-month, well-controlled safety and adhesion trial to assess a modified Viaskin Peanut patch in the intended patient population. The Company later named this clinical trial STAMP, which stands for Safety, Tolerability, and Adhesion of Modified Patches.

Based on the January 2021 FDA feedback, the Company defined three parallel workstreams:

1. Identify a modified Viaskin patch (which the Company calls mVP).

2. Generate thesix-month safety and adhesion clinical data FDA requested via STAMP, which the Company expected to be the longest component of the mVP clinical plan. The Company prioritized the STAMP protocol submission so the Company could begin the clinical trial as soon as possible.

3. Demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population via EQUAL. The complexity of EQUAL hinged on the lack of established clinical and regulatory criteria to characterize allergen uptake via an epicutaneous patch. To support those exchanges, the Company outlined its proposed approach to demonstrate allergen uptake equivalence between thetwo patches, and allotted time to generate informative data throughtwo additional Phase 1 clinical trials in healthy adult volunteers:

a. PREQUAL, a Phase 1 trial with adult healthy volunteers to optimize the allergen sample collection methodologies and validate the assays we intend to use in EQUAL. The data collection phase of the trial is complete, and the data analysis phase is ongoing;

b.“EQUAL in adults”—a second Phase 1 trial with adult healthy volunteers to compare the allergen uptake of cVP and mVP.

In March 2021, the Company commenced CHAMP (Comparison of adHesion Among Modified Patches), a Phase 1 trial in healthy adult volunteers to evaluate the adhesion offive modified Viaskin Peanut patches. The Company completed CHAMP in the second quarter of 2021. All modified Viaskin Peanut patches demonstrated better adhesion performance as compared to the then-current Viaskin Peanut patch, and based on the results of CHAMP, the Company then selectedtwo modified patches that performed best out of thefive modified patches studied for further development. The Company then selected the circular patch for further development, which is approximately 50% larger in size relative to the current patch and circular in shape.

In May 2021, the Company submitted its proposed STAMP protocol to the FDA, and on October 14, 2021, the Company received an Advice/Information Request letter from the FDA. In this letter, the FDA requested a stepwise approach to the modified Viaskin patch development program and provided partial feedback on the STAMP protocol. Specifically, the FDA requested that the Company conducts allergen uptake comparison trials (i.e., “EQUAL in Adults”, EQUAL), and submits the allergen uptake comparison data for FDA review and feedback prior to starting the STAMP study. The FDA’s explanation was that the results from the allergen uptake studies might affect the design of the STAMP study.

After careful review of the FDA’s information requests, in December 2021, the Company decided not to pursue the sequential approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 feedback. The Company estimated that the FDA’s newly proposed

F - 13 sequential approach would require at least five rounds of exchanges that necessitate FDA alignment prior to initiating STAMP, thesix-month safety and adhesion study. As such, in December 2021, the Company announced its plan to initiate a pivotal Phase 3 placebo-controlled efficacy trial for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. The Company considers this approach the most straightforward to potentially demonstrate effectiveness, safety, and improvedin vivo adhesion of the modified Viaskin Peanut system. The FDA confirmed the Company’s change in strategy was agreeable via oral and written exchanges.

In 2022, the Company announced the new Phase 3 pivotal study of the modified Viaskin Peanut (mVP) patch would be in younger (4-7 years old) and more sensitive children with peanut allergy.

On March 2, 2023, the Company announced the completion of EVOLVE, a 12-week caregiver and patient user experience study of the mVP patch in 50 peanut allergic children ages 4–11-years old. The objective of EVOLVE was to evaluate the Instructions for Use (IFU) and ease of use for the mVP patch. The study concluded that the updated IFU supported correct patch application, which included no lifting of the patch edges or detachment directly after application. Furthermore, EVOLVE concluded that the majority of parents/caregivers reported a positive ease of use experience with the mVP patch. In EVOLVE, DBV also tested the functionality of an electronic patient diary (eDiary) to collect information on activities of daily living and patch adhesion scores. EVOLVE verified that the eDiary tool can be used by caregivers in VITESSE to capture the adhesion data in support of a potential BLA.

On March 7, 2023, the Company announced that the first patient was screened in the VITESSE study. Screening of the last patient is anticipated by Q3 2024.

On April 19, 2023, the Company outlined the regulatory path for Viaskin Peanut in children 1-3 years old after the FDA confirmed that the Company’s Phase 3 EPITOPE study meets the pre-specified criteria for success for the primary endpoint, not requesting any additional efficacy study. The FDA requires additional safety data to augment the safety data collected from EPITOPE in support of a BLA. This new safety study will also generate patch adhesion data and will include updated instructions for use.

On July 31, 2023, the Company announced receipt of feedback from FDA on thetwo supplemental safety studies, COMFORT Children and COMFORT Toddlers. The COMFORT Toddlers safety study will enroll peanut allergic toddlers ages 1-3-years and will support the efficacy results generated from the EPITOPE Phase 3 pivotal study. FDA agreed with asix-month study duration and a 3:1 randomization (active: placebo) of approximately 400 subjects in the double-blind, placebo-controlled COMFORT Toddlers study. On March 24, 2025, the Company announced that in a Written Responses Only to the Company’s Type D IND meeting the FDA agreed with the Company’s proposal that the safety exposure data from the VITESSE Phase 3 study for Viaskin peanut patch in 4 – 7-year-olds will be sufficient to support a BLA filing in this age group. As a result, the COMFORT Children supplemental safety study will no longer be required and the Company will not conduct the study. The Company will utilize the safety data from the VITESSE participants randomized to active treatment as well as placebo-crossover participants in the VITESSE Open Label Extension (OLE). Accordingly, the Company plans to submit a BLA in the first half of 2026 and anticipates potentially accelerating the product launch by approximately one year, subject to FDA approval.

Viaskin Peanut for children ages 4-11—European Union Regulatory History and Current Status

On August 2, 2021, the Company announced it received from the EMA the Day 180 list of outstanding issues, which is an established part of the prescribed EMA review process. It is a letter that is meant to include any remaining questions or objections at that stage in the process. The EMA indicated many of their objections and major objections from the Day 120 list of questions had been answered. One major objection remained at Day 180. The Major Objection questioned the limitations of the data, for example, the clinical relevance and effect size supported by a single pivotal study.

On December 20, 2021, the Company announced it withdrew the MAA for Viaskin Peanut and formally notified the EMA of our decision. The initial filing was supported by data from a single, placebo-controlled Phase 3 pivotal trial known as PEPITES (V712-301). The decision to withdraw was based on the view of that the data available to date from a single pivotal clinical trial were not sufficient to preclude a Major Objection at Day 180 in the review cycle. The Company believe data from a second Viaskin Peanut pivotal clinical trial will support a more robust path for licensure of Viaskin Peanut in the EU. The Company intend to resubmit the MAA when that data set is available.

Viaskin Peanut for Children ages 1-3

In June 2020, the Company announced that in Part A, patients in both treatment arms showed consistent treatment effect after 12 months of therapy, as assessed by a double-blind placebo-controlled food challenge and biomarker results. Part A subjects were not included in Part B and the efficacy analyses from Part A were not statistically powered to demonstrate superiority of either dose versus placebo. These results validate the ongoing investigation of the 250 μg dose in this age group, which is the dose being studied in Part B of the study. Enrollment of Part B of EPITOPE was complete in first quarter of 2021.

In June 2022, we announced positive topline results from Part B of EPITOPE, which enrolled 362 subjects ages 1 to 3 years, of which 244 and 118 were in the active and placebo arms, respectively. Enrollment was balanced for age and baseline disease characteristics between the active and placebo treatment arms.

The Company intends to further analyze the data from EPITOPE and explore regulatory pathways for Viaskin Peanut in children ages 1 to 3 years, given the high unmet need and absence of approved treatments for this vulnerable population.

On April 19, 2023, the Company announced it will begin a new safety study after it received confirmation from the FDA that the EPITOPE study meets the pre-specified criteria for success for the primary endpoint, with no additional efficacy study requested. This safety study will increase the safety data collected from EPITOPE in support of a BLA. It will also generate patch adhesion data and will include updated instructions for use.

On May 10, 2023, the New England Journal of Medicine (NEJM) published results that demonstrated epicutaneous immunotherapy (EPIT) with VP was statistically superior to placebo in desensitizing children to peanut exposure by increasing the peanut dose that triggers allergic symptoms. As stated in an accompanying editorial piece, these data are seen as “very good news” for toddlers with peanut allergy, as there are currently no approved treatment options for peanut-allergic children under the age of 4 years. Following this publication, the Company confirmed it is advancing regulatory efforts for VP in toddlers ages 1-3 years old with a confirmed peanut allergy.

In November 2023, the Company announced the interim analyses from the first year of the open-label extension of EPITOPE. These data were presented at the annual American College of Allergy, Asthma and Immunology (ACAAI) in November 2023.

Viaskin Peanut for Children ages 4-7

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On September 7, 2022, we announced the initiation of VITESSE, a new Phase 3 pivotal study of the modified Viaskin Peanut (mVP) patch in children ages 4-7 years with peanut allergy. We defined initiation as the submission of the trial protocol to selected study sites for subsequent Institutional Review Board (IRB) approval and Ethics Committee (EC) opinion.

On September 21, 2022, we announced we had received feedback from the FDA in the form of a partial clinical hold on VITESSE. In the partial clinical hold letter, the FDA specified changes to elements of the VITESSE protocol, acknowledging the intent for the trial to support a future BLA submission. In the following months, we engaged with the FDA to address the feedback provided in the partial clinical hold letter and to finalize the VITESSE protocol. In addition, we continued internal preparations for VITESSE and conducted certain site assessment and start-up activities for prompt study launch once the partial clinical hold was lifted.

On December 23, 2022, we announced the FDA lifted the partial clinical hold and confirmed we satisfactorily addressed all clinical hold issues. The FDA stated that VITESSE may proceed with the revised trial protocol.

On March 7, 2023, the Company announced screening of the first patient in VITESSE.

On September 23, 2024, the Company announced having exceeded its recruitment goal and successfully closed the screening process for the VITESSE Phase 3 study evaluating the Viaskin Peanut Patch in peanut allergic children ages 4 – 7 years old. Topline results of VITESSE data are expected in the fourth quarter 2025.

On March 24, 2025, the Company announced that in a Written Responses Only to the Company’s Type D IND meeting the FDA agreed with the Company’s proposal that the safety exposure data from the VITESSE Phase 3 study for Viaskin peanut patch in 4 – 7-year-olds will be sufficient to support a BLA filing in this age group. As a result, the COMFORT Children supplemental safety study will no longer be required and the Company will not conduct the study. The Company will utilize the safety data from the VITESSE participants randomized to active treatment as well as placebo-crossover participants in the VITESSE Open Label Extension (OLE). Accordingly, the Company plans to submit a BLA in the first half of 2026 and anticipates potentially accelerating the product launch by approximately one year, subject to FDA approval.

Diagnostic Tool Development

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 recorded the following:

–Loss on completion accrual reversal $19.9 million (Other Operating Income);

–Deferred revenue accrual reversal $6.9 million (Operating Expenses);

–Accrual for ongoing Clinical study completion $2.3 million (Operating Expenses). This accrual represented our best estimate of the remaining expenses related to the ongoing clinical study which will be incurred after December 31, 2023 and until the end of the study.

Financing

In May 2022, the Company announced that pursuant to the Company’s At-The-Market program established in May 2022 (the “ATM Program”), it had issued and completed sales of new ordinary shares (the “Ordinary Shares”) in form of American Depositary Shares (“ADSs”), for a total gross amount of $15.3 million ($14.1 million net of transaction costs). In this context,6,036,238 new Ordinary Shares in form of ADS have been 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 dollar per ADS (i.e., a subscription price per Ordinary Share of €2.41 based on the USD/EUR exchange rate of 1.0531 dollar for 1 euro, as published by the European Central Bank on May 4, 2022) and each ADS giving the right to receive one-half of one ordinary share of the Company.

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 $7.8 million on June 14, 2023 (and a net amount of $6.9 million after $0.9 million capital increase fees imputation).

In June 2022, the Company announced an aggregate $194 million ($180.4 million net of transaction costs) private investment in public equity (PIPE) financing (corresponding to €181 million on the basis of an exchange rate of $1.0739 = €1.00 published by the European Central Bank on June 8, 2022) 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 “June 2022 PIPE”). 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 were sold to the purchasers 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. Gross proceeds from the June 2022 PIPE total approximately $194 million (corresponding to €181 million), before deducting private placement expenses.

The ordinary shares issued in the June 2022 PIPE, including the ordinary shares issuable upon exercise of the pre-funded warrants from the PIPE financing, were not been registered under the Securities Act of 1933, as amended, at the time of the offering, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. In connection with the PIPE financing, the Company entered into a registration rights agreement (the “Registration Rights Agreement”), pursuant to which the Company has filed a registration statement with the Securities and Exchange Commission (the “SEC”) registering the resale of 59,269,629 ordinary shares issued in the June 2022 PIPE, including ordinary shares underlying the pre-funded warrants.

From time to time, we may become subject to various legal proceedings and claims that arise in the ordinary course of our business activities. We are not currently subject to any material legal proceedings.

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Note 3 Cash and Cash Equivalents

The following table presents for each reported period, the breakdown of cash and cash equivalents:

Cash equivalents are immediately convertible into cash at no or insignificant cost on demand. They are measured using Level 1 fair value measurements.

Note 4 Other Current Assets

Other current assets consisted of the following:

The other tax claims are primarily related to deductible VAT. Prepaid expenses are comprised primarily of insurance expenses, as well as legal and scientific consulting fees. Prepaid expenses also include upfront payments which are recognized over the term of the ongoing clinical studies.

Research tax credit

In the fiscal year ended December 31, 2021, the Company recovered its Small and Medium-sized Enterprises, or SMEs, status under EU law, and became therefore eligible again for the immediate reimbursement of the Research Tax Credit.

During the year ended December 31, 2023, the Company received the reimbursement of $6.0 million of the 2022 fiscal year research tax credits.

During the year ended December 31, 2024, the Company received the reimbursement of the 2023 fiscal year research tax credits for a total amount of $8.7 million included 2020, 2021 and 2022 complementary research tax credit made during the fiscal year ended December 31, 2023.

The variance in Research Tax Credit during the two years disclosed is presented as follows:

(1)Included 2020, 2021 and 2022 complementary research tax credit made during the fiscal year ended December 31, 2023.

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Note 5 Property, Plant, and Equipment

Property and equipment, net consisted of the following:

The depreciation and amortization expense for each of the years ended December 31, 2024 and 2023 was $2.7 million and $3.6 million respectively.

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Note 6 Lease contracts

Future minimum lease payments under the Company’s operating leases’ right of use as of December 31, 2024 and 2023, are as follows:

The Company recognizes rent expense, calculated as the remaining cost of the lease allocated over the remaining lease term on a straight-line basis. Rent expense presented in the consolidated statement of operations and comprehensive loss was:

In November 2023, the Company signed agreements for the new headquarters in Châtillon, France:

•a short term lease agreement in order to fit the new offices;

•a lease agreement starting on April 16, 2024.

The lease commencement was based upon delivery of possession of the premises by the Landlord and occurred in November 2023. Right of use and related lease debt have been recorded starting November 2023 for a gross amount of $4.5 million.

Supplemental cash flow information related to operating leases is as follows for the year ended December 31, 2024 and 2023:

Note 7 Other non-current assets

Other non-current assets consisted of the following:

The other non-current assets are composed of security deposits paid to premises lessors, pledged securities and the liquidity contract. The collateral account to guarantee a FX facility is released as of December 31, 2024.

Under the liquidity contract,266,868 treasury shares were allocated as a reduction of Shareholders’ Equity as at December 31, 2024 with the cash balance being maintained in financial assets.

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Note 8 Trade payables and Other Current Liabilities

Trade Payables

No discounting was performed on the trade payables to the extent that the amounts did not present payment terms longer than one year at the end of each fiscal year presented.

Other Current Liabilities

Other current liabilities consisted of the following:

Social debt includes short-term debt related to employees’ bonus accruals, as well as social welfare and tax agencies.

Note 9 Other Current Liabilities

Due dates of liabilities

The following table shows the maturity of the Company’s liabilities (except leases disclosed in Note 6—“Lease contract”):

The current portion of other liabilities mainly includes social security.

Note 10 Fair Value Measurement

The Company reports assets and liabilities recorded at fair value on the Company’s consolidated balance sheets based upon the level of judgment associated with inputs used to measure their fair value.

The fair value measurement level within the fair value hierarchy for a particular asset or liability is based on the lowest level of any input that is significant to the fair value measurement. Valuation techniques maximize the use of observable inputs and minimize the use of unobservable inputs.

Financial instruments not measured at fair value on the Company’s consolidated statement of financial position, but which require disclosure of their fair values include cash and cash equivalents, accounts receivable, deposits, liquidity contract, accounts payable and conditional advances. The fair values of these financial instruments are deemed to approximate their carrying amount.

The fair values of cash and cash equivalents, accounts receivable, deposits, liquidity contract and accounts payable are categorized as Level 1. The fair value of conditional advance was categorized as Level 2 and was estimated based on a discounted cash flow method using the effective interest rate. For the interest-free conditional advances, the discount rate applied is equal to the rate of fungible treasury bonds over the time period that corresponds to the time period of the repayment of the advances.

There has been no transfer between levels of the fair value hierarchy during the years ended December 31, 2023 and 2024.

Note 11 Share Capital Issued

The share capital, as of December 31, 2024, is set at the sum of €10,284,750 ($11,650,708 converted at historical rates). It is divided into 102,847,501 fully authorized, subscribed and paid-up shares with a nominal value of €0.10.

This number does not reflect ordinary shares issuable upon exercise or settlement of non-employee warrants (“BSA”), stock options (“SO”) and restricted stock units (“RSU”) granted to both employees and non-employees of the Company.

All the shares give their owners the right to a proportional share of the income and the net assets of the Company. Pursuant to the authorization granted by the SH General Meeting, the Board of Directors, at its meeting of June 9, 2023 (the “Board General Meeting”):

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•decided, within the framework of the June 2022 PIPE the principle of a capital increase in cash with cancellation of preferential subscription rights, reserved for categories of persons meeting the characteristics set out in the 18 th resolution of the Board General Meeting, through the issuance of Ordinary Shares and warrants to subscribe for Ordinary Shares, for a maximum amount of 6,113,200 New Ordinary Shares, corresponding to the maximum issue ceiling under the 22 nd resolution of the Board General Meeting;

•granted a number of authorizations for the purpose of carrying out the issuance;

•sub-delegated its authority to the Chief Executive Officer for the purpose of implementing the financing.

The Chief Executive Officer, acting pursuant to the sub-delegations of authority granted by the Board of Directors of the Company on June 8, 2022, after receiving the favorable opinion of the Pricing Committee established by the Board of Directors, has, on June 9, 2022:

•decided, making use of the 18 th resolution of the Board General Meeting, to proceed with a capital increase in cash with cancellation of preferential subscription rights reserved for categories of investors, in accordance with the Article L. 225-128 of French Commercial Code, an amount of €3,285,566.90, through the issuance of (i)32,855,669 New Ordinary Shares, to be subscribed in cash at a unit price of €2.90 of share premium and to be fully paid up at the time of subscription, i.e. a capital increase of a nominal amount of €3,285,566.90 together with a share premium of €95,281,440.10, i.e. a gross amount of the capital increase of €98,567,007, and (ii)28,276,331 prefunded warrants to be subscribed in cash by paying up on the date of issue of €82,001,359.90 corresponding to the prepayment of the subscription price of the new ordinary shares in the event of exercise of the prefunded warrants;

•decided to set the maximum nominal amount of the capital increase resulting from the full exercise of the prefunded warrants at €2,827,633.10, by issuing a maximum of 28,276,331 ordinary shares, with a value of €0.10 to be subscribed in cash at the price of €0.10 (without share premium), and to be fully paid up at the time of subscription, i.e. a capital increase of a maximum nominal amount of €2,827,633.10 (and a share premium corresponding to the amount of the pre-financed price released in advance at the time of the subscription of the prefunded warrants ), being specified that this amount does not take into account the nominal value of the ordinary shares to be issued in order to preserve the rights of the holders of securities giving access to the capital issued or to be issued, in accordance with the legal and regulatory provisions and the contractual stipulations providing for other cases of adjustment if necessary;

•determined the list of beneficiaries (designated within each of the categories of persons defined in the 18 th resolution of the Board General Meeting) and the number of New Ordinary Shares and warrants allocated to each of them under the conditions defined in the 18 th resolution of the Board General Meeting beneficiaries under the conditions defined in section 5 of the offering circular relating to the June 2022 PIPE.

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 changes in number of outstanding prefunded warrants are as follows:

The table below presents the changes in the share capital of the Company as of December 31, 2023 and 2024:

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(Amounts in thousands of U.S. Dollars except share and per share data)

In May 2024, pursuant to the authorization granted by the General Meeting of the Shareholders held on May 16, 2024, the accumulated net losses of DBV Technologies S.A. after appropriation of the net result for the year ended December 31, 2023 have been allocated to additional paid-in capital in the amount of $66.4 million (€61.1 million converted at historical rates).

Note 12 Share-Based Payments

The Board of Directors has been authorized by the General Meeting of the Shareholders to grant restricted stock units (“RSU”), stock options plan (“SO”), and non-employee warrants (bons de souscription d’actions or “BSA”), as follows:

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In the following tables related to share-based payments, exercise prices, grant date share fair values and fair value per equity instruments are provided in euros, as the Company is incorporated in France and the euro is the currency used for the grants.

12.1 Non-employee warrants

The Company’s board of directors has been authorized by the shareholders’ general meeting to grant BSAs to non-employee’s members of the Board of Directors and members of the Scientific Advisory Board.

The BSAs plans granted by the Board of Directors until 2018 are similar in their nature and conditions, except for the exercise price that is comprised between €5.13 and €69.75.

During the year ended December 31, 2021, pursuant to the authorization granted by the General Meeting of the Shareholders held on May 19, 2021, the Company offered the directors the opportunity to subscribe for warrants to purchase ordinary shares on May 19, 2021 and on June 3, 2021, the directors subscribed for warrants to purchase an aggregate of 39,185 ordinary shares. These warrants have a contractual life of 4 years from their date of issuance and are not subject to a performance condition. Unless otherwise decided by the Board of Directors, these warrants may be exercised at any time prior to their expiration, provided that the beneficiary still holds a seat on the Board of Directors at the time of exercise, and subject to applicable French laws and regulations applicable to companies whose securities are listed on a regulated stock market. The fair value of the warrants has been estimated using the Cox-Ross Rubinstein binomial option pricing model.

Warrant fair value assumptions during the year ended December 31, 2021:

The following table summarizes all BSA warrants activity during the year ended December 31, 2023:

The following table summarizes all BSA activity during the year ended December 31, 2024:

12.2 Employee warrants

As of December 31, 2023 no more BSPCE / BCE warrants (Bons de Souscription de Parts de Créateur d’Entreprise or “BSPCE”) are exercisable.

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12.3 Stock options

The Company’s Board of Directors has been authorized by the shareholders’ general meeting to grant SOs to employees.

The different stock options plans granted by the Board of Directors are similar in their nature and conditions, except for the exercise price that is comprised between €0.71 and €74.22.

All SO issued have aten-year contractual life. SO are expensed in accordance with the following vesting conditions:

•Before June 22, 2018 and from January 15, 2020 to July 29, 2022, SO granted mainly vest over four years at a rate of 25% upon the first anniversary of the issuance date and 12.5% every six months thereafter, subject to the beneficiary being still employed by the Company (except in specific contractual clause or board of directors’ decisions).

•Between June 22, 2018 and January 15, 2020, SO may be exercised by the beneficiary once both of the following conditions have been met:

–service condition:25% upon the first anniversary of the issuance date and 12.5% every six months thereafter, subject to the beneficiary being still employed by the Company (except in specific contractual clause or board of directors’ decisions); and

–performance condition: approval of Viaskin™ Peanut by the US Food and Drug Administration.

•Since November 21, 2022, SO granted mainly vest over four years at a rate of 25% upon the first anniversary of the issuance date and 25% every 12 months thereafter, subject to the beneficiary being still employed by the Company (except in specific contractual clause or board of directors’ decisions).

Performance conditions which are other than market conditions, are taken into account by adjusting the number of equity instruments included in the measurement of the transaction amount but are not taken into account when estimating the fair value of the shares. Estimated achievement of performance conditions is reviewed at each reporting date.

The Company also applied a forfeiture rate for each grant according to its respective characteristics and composition. This forfeiture rate is reviewed at each reporting date.

The following table summarizes all stock options activity during the year ended December 31, 2023:

The following table summarizes all stock options activity during the year ended December 31, 2024:

As of December 31, 2024, there was €17.9 million ($19.3 million converted at closing rate) of unrecognized SO expense that is expected to be recognized over a weighted-average period of 3.5 years.

Fair value of stock options

Determining the fair value of the share-based payments at the grant date requires judgment. The Company calculated the fair value of stock options instruments 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 the Company’s stock awards 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 stock options maturity.

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Expected term

The Company determines the expected term based on the average period the stock options are expected to remain outstanding.

Expected Volatility

The Company determines the expected volatility based on the historical data period corresponding to the stock options expected maturity.

Expected Dividend yield

The Company has never declared or paid any cash dividends, and it does not presently plan to pay cash dividends in the foreseeable future. Consequently, the Company uses an expected dividend yield of zero.

The Company estimated the following assumptions for the calculation of the fair value of the stock options:

12.4 Restricted stock units

The Company’s board of directors has been authorized by the shareholders’ general meeting to grant RSUs to employees.

RSUs are measured based on the fair market value of the underlying stock on the date of grant and recognized as an expense on a straight-line basis in accordance with the following vesting conditions:

•Before May 31, 2019, the vesting of RSUs granted is subject to the expiration of the presence condition of one (1) or two (2) years (except in specific board of directors’ decisions). The release of RSUs for these plans is subject to the achievement of performance conditions (submission of a BLA to U.S. FDA for Viaskin™ Peanut, approval of Viaskin™ Peanut by the U.S. FDA, first sale of Viaskin™ Peanut in the United States).

•Between May 31, 2019 and November 23, 2020, the vesting of RSUs is subject either to the expiration of the presence condition of two (2) years only, or to the dual condition of expiration of the presence condition and achievement of the performance condition (date of approval of Viaskin™ Peanut by the U.S. FDA).

•Between November 24, 2020 and July 29, 2022, RSUs vest over four years at a rate of 25% upon the first anniversary of the issuance date and 12.5% every six months thereafter, subject to the beneficiary being still employed by the Company (except in specific board of directors’ decisions).

•Since November 21, 2022, RSUs vest over four years at a rate of 25% upon the first anniversary of the issuance date and 25% every 12 months thereafter, subject to the beneficiary being still employed by the Company (except in specific contractual clause or board of directors’ decisions).

Performance conditions, which are other than market conditions, are taken into account by adjusting the number of equity instruments included in the measurement of the transaction amount but are not taken into account when estimating the fair value of the shares. Estimated achievement of performance conditions is reviewed at each reporting date.

RSU plans may be subject to a conservation period under French governing laws.

The Company applied a forfeiture rate for each grant according to its respective characteristics and composition. This forfeiture rate is reviewed at each reporting date.

The following table summarizes all RSUs activity for the year ended December 31, 2023:

The following table summarizes all RSUs activity for the year ended December 31, 2024:

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As of December 31, 2024, there was €3.8 million (US$4.2 million converted at closing rate) of unrecognized RSUs compensation expense that is expected to be recognized over a weighted-average period of 3.2 years.

12.5 Reconciliation of the share-based payment expenses with the Consolidated Statements of Operations and Comprehensive Loss

Note 13 Contingencies

Non-current contingencies and current contingencies break down as follows:

The table below shows movements in contingencies:

The Company does not hold any plan assets for any of the periods presented.

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The evolution as of December 31, 2024 compared with December 31, 2023 is mainly due to the signature by the Company of a Mutual Termination Letter Agreement with NESTEC on October 30, 2023 which generated the following impacts as of December 31, 2023 :

•Loss on completion accrual reversal of $19.9 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 remaining expenses related to the ongoing clinical study which will be incurred after December 31, 2024 and until the end of the study.

As part of the estimation of the retirement commitments, the following assumptions were used for all categories of employees:

Note 14 Operating Income

The operating income is broken down in the following manner:

Until the end of 2023, our operating income was composed of both the French Research tax credit (Crédit d’Impôt Recherche, or “CIR”) and the revenue recognized under the Collaboration Agreement with NESTEC. Following the termination of the Collaboration Agreement on October 30, 2023, we recorded a deferred revenue accrual reversal of $7.0 million and our operating income is now exclusively generated by the French research tax credit.

The decrease in Research tax credit was primarily due to:

◦a complementary Research tax credit for $2.9 million recorded in 2023 for the years 2020, 2021 and 2022

◦a greater proportion of study activities carried out in North America in 2024, compared with 2023, that were therefore not eligible to the French Research tax credit.

Note 15 Operating expenses and Allocation of Personnel Expenses

Operating expenses

The following table summarizes our research and development expenses for the years presented:

Research and Development expenses increased by $29.1 million for the year ended December 31, 2024 compared to the year ended December 31, 2023, essentially due to external clinical-related expenses increasing by $13.4 million from both patient enrollment in VITESSE Phase 3 clinical trial sustainable increase after the initiation of the study with the first patient screened in March 2023 and the preparatory activities for the COMFORT studies in preparation for and anticipation of initiation after FDA alignment.

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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 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, due to (1) the termination of the Collaboration Agreement with NESTEC that explained the accrual net reversal in 2023, (2) accruals reversal on CRO activities and (3) Medical, Quality and Regulatory Affairs activities.

Sales and Marketing Expenses

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

Sales and marketing expenses increased by $0.2 million or the year ended December 31, 2024 compared to the year ended December 31, 2023, primarily to support pre-commercialization activities for Viaskin Peanut in North America.

General and Administrative Expenses

The following table summarizes our general and administrative expenses for the years presented:

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 provision reversal on the Montrouge office revamping.

Allocation of Personnel Expenses by Function:

The Company had 108 average employees for the year ended December 31, 2024, in comparison with 104 employees for the year ended December 31, 2023.

Allocation of Personnel Expenses by Nature:

The increase in personnel expenses is mainly due to the recruitment of internal resources mostly based in North America to support development activities and quality activities.

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Note 16 Income Tax

Reconciliation between the Effective and Nominal Income Tax Expense

The following table shows the reconciliation between the effective and nominal tax expense at the nominal standard French rate 25% as of December 31, 2024 and December 31, 2023 (excluding additional contributions):

Deferred Tax Assets

Deferred taxes are recognized for temporary differences between the basis of assets and liabilities for financial statement and income tax purposes. The significant components of the Company’s deferred tax assets are comprised of the following:

Note 17 Commitments

Purchase Obligations

The Company has signed agreements with several contract research organizations (CRO) and part of the ongoing clinical studies for Viaskin Peanut and Viaskin Milk products. 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 year ended 2026 amounting to $10.0 million.

Letter of Credit and Collateral

A Certificate of Deposit, for an initial amount of $0.25 million was signed in order to guarantee an American Express credit cards program in the United States.

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Note 18 Relationships with Related Parties

The compensation amounts for 2024 presented below, which were awarded to the Directors and Officers of the Company totaled $8.5 million. The recipients of this compensation are “related parties” under applicable French law and may not be considered executive officers or related parties under comparable SEC and Nasdaq rules and regulations applicable to the Company.

The methods for the valuation of the benefit related to share-based payments are presented in Note 12 Share-Based Payments.

Amounts payable to related parties as of December 31, 2024 and 2023 are as follows:

Note 19 Loss Per Share

The basic loss per share is calculated by dividing the net loss attributable to the shareholders of the Company by the weighted average number of ordinary shares outstanding during the course of the fiscal year. As the Company was in a loss position for the years ended December 31, 2024 and 2023, the diluted loss per share is equal to basic loss per share because the effects of potentially dilutive shares were anti-dilutive given the Company’s net loss.

The computations for basic and diluted loss per share were as follows (in thousands of U.S. Dollars except share and per share data):

The following is a summary of the ordinary share equivalents which were excluded from the calculation of diluted net loss per share for the periods indicated in number of potential shares:

Note 20 Events after the Close of the Fiscal Year

On March 27, 2025, the company announced a financing of up to $306.9 million (€284.5 million), to Advance Viaskin® Peanut Patch Through Biologics License Application Submission and U.S. Commercial Launch, if Approved. The financing includes gross proceeds of $125.5 million (€116.3 million) received on April 7 2025 and up to $181.4 million (€168.2 million) in potential additional gross proceeds that may be received if all the warrants are exercised, subject to satisfaction of specified conditions. The VITESSE Phase 3 study hitting its primary endpoint will trigger an acceleration of the exercise period of some of the warrants. The ABSA Warrants will be exercisable from their respective date of issue until the earlier of (i) April 7, 2027 and (ii) 30 days following the publication by the Company of a press release announcing that the ongoing VITESSE trial of Viaskin peanut in 4-7 years old met the primary endpoint defined in the VITESSE study protocol, it being specified that (i) the primary measure of treatment effect will be the difference in response rates at Month 12 between active and placebo treatment groups, (ii) the primary analysis will be based on a 2-sided confidence interval ("CI") for the difference in response rates and (iii) the primary analysis must be positive according to the success criterion (lower bound of the 2-sided 95% CI of the difference in response rates ≥15%) (the "ABSA Warrant Exercise Period"). The exercise of one (1) ABSA Warrant will give the right to subscribe to one point seventy-five (1.75) ABSA Warrant Shares at a price of €1.5939 per ABSA Warrant

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The financing results in an immediate dilution of 22.4% and a maximal dilution of up to 73.7% of existing shareholders (on a non-diluted basis) if all the warrants in the offering are exercised in full.

The financing consists of:

• 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

• 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"),

(together, the "Offering").

The net proceeds from the issue of the ABSA and the PFW-BS-PFW, together with existing cash and cash equivalents, will be mainly used in the following order of priority (i) for working capital and general corporate purposes, (ii) to finance the continued development of the Viaskin Peanut program, (iii) to finance the preparation and submission of a potential BLA and, (iv) to finance the readiness of a launch of Viaskin peanut in the US, if approved.

As of the date of authorization of these financial statements the Company is in a process of assessing the accounting implications.

Taking into account the net proceeds of $125.5 million (€116.3 million) received on April 7, 2025 from the issuance of the ABSA and the PFW-BS-PFW and based on its current operations, plans and assumptions, the Company estimates that it has sufficient balance of cash & cash equivalents to fund its operations into June 2026.

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Note 21 Reportable Segment Disclosure

The Company operates and is managed asone operating segment driving expenses for the development of Viaskin Peanut. The Company’s R&D organization is primarily responsible for the development and registration efforts of Viaskin Peanut. The Company’s technical operations group is responsible for the development of manufacturing processes, supplying clinical drug product. The Company is also supported by corporate staff functions.

The Company’s Chief Executive Officer as the CODM manages and allocates resources to the operations of the total company by assessing the overall level of resources available and how to best allocate them to support the Company’s long-term company-wide strategic goals. In making this decision, the CODM uses consolidated financial information for the purposes of evaluating performance, allocating resources, setting incentive compensation targets and planning and forecasting for future periods.

The CODM's analysis includes a comparison to budgeted results. Segment assets provided to the CODM are consistent with those reported on the Consolidated Statement of Financial Position with particular emphasis on the Company's available liquidity including cash, cash equivalents.

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