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DBV Technologies S.A.

For the period ended Jun 30, 2025. Filed Jul 29, 2025.

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About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2025 · Filed Jul 29, 2025

DBVT$11.05+5.7%Stored close · as of Nov 9, 2026

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Notes to the Condensed Consolidated Financial Statements (Unaudited)

Note 1: The Company

Incorporated in 2002 under the laws of France, DBV Technologies S.A. (“DBV Technologies” or the “Company”) 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 (“EPIT”), a method of delivering biologically active compounds to the immune system through intact skin using the Viaskin patch.

Basis of Presentation

The condensed consolidated financial statements of the Company and its wholly-owned subsidiaries are unaudited and have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) and are presented in U.S. dollars. All significant intercompany accounts and transactions between the Company and its subsidiaries have been eliminated on consolidation.

The unaudited condensed consolidated financial statements presented in this Quarterly Report should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K filed with the SEC on April 11, 2025, as amended by Amendment No. 1 on Form 10-K/A filed with the SEC on April 28, 2025, and as amended further by Amendment No. 2 on Form 10-K/A filed with the SEC on May 14, 2025. The condensed consolidated statement of financial position as of December 31, 2024 was derived from the audited consolidated financial statements but does not include all disclosures required by U.S. GAAP. The Company’s critical accounting policies are detailed in the Annual Report. The Company’s critical accounting policies have not changed materially since December 31, 2024.

Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted from these interim financial statements. However, these condensed consolidated financial statements include all adjustments, consisting only of normal recurring adjustments, which are, in the opinion of management, necessary to fairly state the results of the interim period. These interim financial results are not necessarily indicative of results to be expected for the full fiscal year ending December 31, 2025, or any other future period.

Use of Estimates

The preparation of the Company’s condensed 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 condensed 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. The Company evaluates its estimates and assumptions on an ongoing basis. The actual results may differ from these estimates.

On an on-going basis, management evaluates its estimates, primarily those related to: (1) research tax credits, (2) assumptions used in the valuation of right of use assets—operating lease, (3) impairment of right-of-use assets related to leases and property, plant and equipment, (4) recoverability of the Company’s net deferred tax assets and related valuation allowance, (5) assumptions used in the valuation model to determine the fair value and vesting conditions of share-based compensation plan, 6) estimate of contingencies and provisions.

Going Concern

These Condensed 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 the Viaskin Peanut patch’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 March 27, 2025, the Company announced the 2025 PIPE. On April 7, 2025, the Company received gross proceeds of $125.5 million (€116.3 million) from the issuance of securities including, ABSAs and PFW-BS-PFWs, as described in the Company’s Quarterly Report on Form 10-Q for the Quarter ended March 31, 2025 filed with the SEC on April 30, 2025.

As of the date of the filing, with the receipt of the aforementioned proceeds, and based on its current operations, plans, and assumptions examined by the Board on June 23, 2025, the Company estimates that its cash and cash equivalents are sufficient to fund its operations into the second quarter of 2026. As such, cash and cash equivalents are not sufficient to fund operations for the next 12 months, and there is substantial doubt regarding our ability to continue as a going concern.

The Company financing also includes an aggregate of up to $181.4 million (€168.2 million) in gross proceeds if all 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 the warrants. DBV expects that the proceeds of this funding will be used for working capital and general corporate purposes, to finance the continued development of the Viaskin Peanut program, to finance the preparation and submission of a potential Biologics License Application (“BLA”) and, to finance the readiness of a launch of Viaskin peanut in the US, 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.

Accounting Pronouncements Recently Adopted

ASU 2023-07, Segment Reporting (Topic 280) has been adopted in 2024 10K and during the period

There are no recently issued accounting standards that are expected to have a material impact on our results of operations, financial condition, or cash flows.

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 2023-09 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 2024-03 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

Clinical Programs

United States Regulatory History and Current Status

In August 2019, we announced the submission of a BLA to the FDA for the Viaskin Peanut patch for the treatment of peanut allergy in children four to 11 years of age.

In August 2020, the Company received a Complete Response Letter (“CRL”) in which the FDA indicated it could not approve the Viaskin Peanut patch BLA in its then-current form. The FDA did not raise any safety concerns related to the Viaskin Peanut patch.

In January 2021, the Company received written responses from the FDA to questions provided in the Type A meeting request that the Company submitted in October 2020 following receipt of the CRL.

In March 2021, the Company commenced CHAMP (Comparison of adHesion Among Modified Patches), a Phase 1 trial in healthy adult volunteers. In May 2021, the Company submitted a proposed protocol to the FDA for STAMP (Safety, Tolerability, and Adhesion of Modified Patches)a 6-month safety and adhesion study which was to be conducted concurrently with DBV’s allergen uptake comparison studies (i.e., ‘EQUAL in Adults’, EQUAL). On October 14, 2021, in an Advice/Information Request letter, the FDA requested the Company conduct a stepwise, or sequential, approach to the modified Viaskin patch development program by conducting EQUAL first and submitting the data for FDA review and feedback prior to starting the STAMP study.

In December 2021, the Company decided not to pursue the sequential approach requested by the FDA and instead 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. Following written exchanges with the FDA, the FDA confirmed it was aligned with the Company’s strategy.

On September 7, 2022, the Company announced the initiation of VITESSE, a Phase 3 pivotal study of the mVP in children ages 4-7 years with peanut allergy. On September 21, 2022, the Company announced it received from FDA a partial clinical hold letter related to certain design elements of VITESSE.

On December 23, 2022, the Company announced that the FDA lifted the partial clinical hold The Company announced on September 23, 2024, that subject screening was completed in the third quarter of 2024. Topline results are anticipated in the fourth quarter of 2025.

In June 2022, the Company announced positive topline results from Part B of the Company’s EPITOPE phase 3 study assessing the safety and efficacy of the Viaskin Peanut patch for the treatment of peanut-allergic toddlers 1 - 3 years of age (“EPITOPE”).

On April 19, 2023, the Company outlined the regulatory pathway for the Viaskin Peanut patch in children 1 – 3 years old after the FDA confirmed in written responses to the Company’s Pre-BLA meeting request that the Company’s EPITOPE phase 3 study met the pre-specified criteria for success for the primary endpoint and did not request an additional efficacy study in this age group. The FDA required additional safety data to augment the safety data collected from EPITOPE in support of a BLA.

On July 31, 2023, the Company announced receipt of feedback from FDA ontwo supplemental safety studies, COMFORT Children and COMFORT Toddlers.

On November 9, 2023, the Company submitted the protocol for its COMFORT Toddlers supplemental safety study in 1 – 3 years-old to FDA. The Company received comments and queries to the protocol from the FDA on March 11, 2024. On July 30, 2024, the Company announced that it and the FDA had been engaged in ongoing dialogue since May 2023 on the COMFORT Toddlers supplemental safety study in 1 – 3 years-old with a peanut allergy.

The Company also announced on November 9, 2023, 2-year results from the ongoing phase 3 open-label extension to the EPITOPE trial, EPOPEX, of the Viaskin Peanut patch in toddlers.

On October 22, 2024, the Company announced positive regulatory updates for the Viaskin Peanut patch in the United States and Europe. DBV had agreed to guidance provided by the FDA on a potential pathway under the Accelerated Approval Program for the Viaskin Peanut patch in toddlers ages 1 – 3 years-old. FDA confirmed that the Company has met Accelerated Approval qualifying criterion 1 and 2. Regarding criterion 3, FDA has provided guidance and suggestion regarding the intermediate clinical endpoint, which the Company agreed to in informal discussions with the FDA. The Company formalized the Accelerated Approval guidance provided by FDA via submission of a meeting request and confirmed the general elements of thetwo study components: the COMFORT Toddlers safety study, to be completed before BLA submission, and the confirmatory effectiveness study, including the third Accelerated Approval criterion regarding the intermediate clinical endpoint. The Company expects that the confirmatory study will be initiated by the time of BLA submission and would run in parallel to commercialization in the United States, if the Viaskin Peanut patch is approved.

The Company announced further that it has aligned with FDA on a wear time collection methodology in COMFORT Toddlers intended to generate sufficient data to support a BLA submission. DBV initiated study start-up activities and screened the first subject in the trial as announced on June 25, 2025. The company anticipates enrolling approximately 300 –350 subjects on active treatment into the safety study, which would bring the total Viaskin Peanut patch safety database in toddlers to approximately 600 subjects, consistent with prior FDA guidance. With this path forward, the BLA submission for the Viaskin Peanut patch in 1 – 3 years-old under the Accelerated Approval program is anticipated to be supported by:

ii. Additional safety data generated in COMFORT Toddlers supplemental safety study, which was initiated in June 2025.

On December 11, 2024, the Company announced that it reached alignment with FDA on the Accelerated Approval pathway for Viaskin Peanut patch in toddlers 1 – 3 years-old and on key study design elements for the COMFORT Toddlers study, including study size and wear time collection methodology and analysis. The Company announced further that FDA confirmed criteria for a post-marketing confirmatory study in toddlers 1-3 years-old and that the Company and FDA agreed that the confirmatory study will assess the effectiveness of the intended commercial Viaskin Peanut patch, will include a double-blind, placebo-controlled food challenge (DBPCFC), will use the same statistical criteria for success (i.e., lower bound of the 95% CI > 15%) as used in the EPITOPE, and will need to be initiated at the time that the BLA is submitted.

The Company submitted the protocol for its COMFORT Children supplemental safety study in ages 4-through-7-years-old to the FDA on November 29, 2023. On March 24, 2025, the Company announced that in a Written Responses Only to the Company’s Type D IND meeting request the FDA agreed with the Company’s proposal that the safety exposure data from the VITESSE Phase 3 study for the 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 is no longer required and the Company will not conduct the study. The Company will utilize safety data from VITESSE participants randomized to active treatment as well as placebo-crossover participants in the VITESSE Open Label Extension (OLE) study. Accordingly, the Company plans to submit a BLA for the Viaskin Peanut patch in 4-7 year-olds in the first half of 2026 and anticipates potentially accelerating the product launch by approximately one year, subject to FDA approval.

Viaskin Peanut —European Union Regulatory History and Current Status

In November 2020, we announced that our Marketing Authorization Application, or MAA, for the Viaskin Peanut patch, submitted under the name “Abylqis®”, had been validated by the European Medicines Agency, or EMA. The validation of the MAA confirmed that the submission was sufficiently complete to begin the formal review process for the Viaskin Peanut patch to treat peanut allergies in children ages four to 11 years. Following the MAA validation, the EMA’s Committee for Medicinal Products for Human Use, or CHMP, reviews the application and provides a recommendation to the European Commission, on whether to grant a marketing authorization.

On August 2, 2021, we announced we had received from the EMA the Day 180 list of outstanding issues, which is an established part of the prescribed EMA review process. The EMA identifiedone Major Objection remained at Day 180n questioning the limitations of the data, for example, the clinical relevance and effect size supported by a single pivotal study.

On December 17, 2021, we announced we had withdrawn the MAA for the Viaskin Peanut patch, submitted under the name “Abylqis”, and formally notified the EMA of our decision.

On October 22, 2024, the Company announced it received scientific advice from EMA on an indication for ages 1 – 7 years-old in Europe regarding the components of a MAA for the Viaskin Peanut patch. Previous advice obtained fromtwo local country regulatory health authorities indicated a potential path for a 1 – 7 year-old registration withone patch, the modified patch. The EMA recently confirmed through scientific advice that the completed EPITOPE study in 1 – 3 years-old, and a positive VITESSE study in 4 – 7 years-old, could constitute an MAA submission for a 1 – 7 years-old indication for peanut allergy patients using the modified patch, along with a new safety study in toddlers ages 1 – 3 years-old also with the modified patch. Timing for the initiation of this new safety study to satisfy the important EU market is currently being planned.

The Company intends 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 of the EPITOPE phase 3 clinical study subject in both treatment arms showed consistent treatment effects 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.

In June 2022, the Company announced positive topline results from Part B of EPITOPE.

On April 19, 2023, the Company outlined the regulatory pathway for the Viaskin Peanut patch in children 1 – 3 years old after the FDA confirmed in written responses to the Company’s Pre-BLA meeting request that the Company’s EPITOPE phase 3 study met the pre-specified criteria for success for the primary endpoint and did not request any additional efficacy study in this age group. The FDA requires additional safety data to augment the safety data collected from EPITOPE in support of a BLA. The COMFORT Toddlers supplemental safety study, which was initiated in June 2025, will augment the safety data collected from EPITOPE in support of a BLA, will generate patch adhesion data, and will include updated instructions for use.

On May 10, 2023, the New England Journal of Medicine (“NEJM”) published results from the EPITOPE phase 3 clinical study that demonstrated EPIT with the Viaskin Peanut patch 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.

In November 2023, the Company announced the interim analyses from the first year of the open-label extension of EPITOPE, called EPOPEX, which showed improvement between months 12 and 24 of treatment with the Viaskin Peanut patch across all efficacy parameters. These data were presented at the annual American College of Allergy, Asthma and Immunology (ACAAI) in November 2023.

On November 9, 2023, the Company submitted the protocol for its COMFORT Toddlers supplemental safety study in 1 - 3 years-old to FDA. The Company received comments and queries to the protocol from the FDA on March 11, 2024.

On October 22, 2024, the Company announced positive regulatory updates for the Viaskin Peanut patch in the United States and Europe. DBV agreed to guidance provided by the FDA on a potential pathway under the Accelerated Approval Program for the Viaskin Peanut patch in toddlers ages 1 – 3 years-old.

FDA confirmed that the Company has met Accelerated Approval qualifying criteria 1 and 2. Regarding criterion 3, FDA has provided guidance and suggestion regarding the intermediate clinical endpoint, which the Company has agreed to in informal discussions with the FDA. The Company formalized the Accelerated Approval guidance provided by FDA via submission of a meeting request and confirmed the general elements of the two study components: the COMFORT Toddlers safety study, to be completed before BLA submission, and the confirmatory effectiveness study, including the third Accelerated Approval criterion regarding the intermediate clinical endpoint. The Company expects that the confirmatory study will be initiated by the time of BLA submission and would run in parallel to commercialization in the United States, if the Viaskin Peanut patch is approved.

The Company announced further that it has aligned with FDA on a wear time collection methodology in COMFORT Toddlers that provides a practical approach for subjects and families, is intended to generate sufficient data to support a BLA submission, and places wear time into an acceptable clinical hierarchy relative to other study endpoints. DBV has initiated study start-up activities and plans to screen the first subject in the second quarter of 2025. The company anticipates enrolling approximately 300 -350 subjects on active treatment into the safety study, which would bring the total Viaskin Peanut patch safety database in toddlers to approximately 600 subjects, consistent with prior FDA guidance. With this path forward, the BLA submission for Viaskin Peanut patch in 1 – 3 years-old under the Accelerated Approval program is anticipated to be supported by:

ii. Additional safety data generated in COMFORT Toddlers supplemental safety study, which was initiated in June 2025.

On December 11, 2024, the Company announced that it reached alignment with FDA on the Accelerated Approval pathway for Viaskin Peanut patch in toddlers 1-3 years-old and on key study design elements for the COMFORT Toddlers study, including study size and wear time collection methodology and analysis. The Company announced further that FDA confirmed criteria for a post-marketing confirmatory study in toddlers 1-3 years-old and that the Company and FDA agreed that the confirmatory study will assess the effectiveness of the intended commercial Viaskin Peanut patch, will include a double-blind, placebo-controlled food challenge (DBPCFC), will use the same statistical criteria for success (i.e., lower bound of the 95% CI >15%) as used in the EPITOPE, and will need to be initiated at the time that the BLA is submitted.

Viaskin Peanut for Children Ages 4 – 7

On September 7, 2022, the Company announced the initiation of VITESSE, a Phase 3 pivotal study of the mVP in children ages 4-7 years with peanut allergy.

On September 21, 2022, the Company announced it received from the FDA a partial clinical hold letter related to certain design elements of VITESSE. The Company announced on December 23, 2022 that the FDA lifted the partial clinical hold. The Company announced on September 23, 2024 that subject screening was completed in the third quarter of 2024. Topline results are anticipated in the fourth quarter of 2025.

In July 2023, the Company received Type C Meeting Written Responses from the FDA regarding key study design elements for COMFORT Children. Subsequently, in October 2023, the Company received feedback from the FDA addressing the remaining protocol design elements for COMFORT Children.

The Company submitted the protocol for its COMFORT Children supplemental safety study in 4--7-years-old to the FDA on November 29, 2023.On March 24, 2025, the Company announced that in a Written Responses Only to the Company’s Type D IND meeting request 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 is no longer required and the Company will not conduct the study. The Company will utilize safety data from VITESSE participants randomized to active treatment as well as placebo-crossover participants in the VITESSE Open Label Extension (OLE) study. Accordingly, the Company plans to submit a BLA for the Viaskin Peanut patch in 4-7 year-olds in the first half of 2026 and anticipates potentially accelerating the product launch by approximately one year, subject to FDA approval.

Financing

On March 27, 2025, the Company announced a financing of up to $306.9 million (€284.5 million at $1.0739:1€ as per European Central Bank on March 27, 2025), to advance the Viaskin Peanut patch through BLA 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 (defined below) 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 the Viaskin Peanut patch in children 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 holder the right to subscribe to one point seventy-five (1.75) ABSA Warrant Shares at a price of €1.5939 per ABSA Warrant.

The financing resulted 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 consisted 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 $42 million (€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 $86 million (€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 ofone pre-funded warrant to subscribe forone share of the Company (the "First Pre-Funded Warrants") andone warrant (the "BS Warrants") to subscribe toone 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 by the Company 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 U.S., if approved.

The ordinary shares, including the ordinary shares issuable upon exercise of the warrants from the Offering, have not been registered under the Securities Act 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. Pursuant to the registration rights agreement with each investor participating in the Offering, the Company filed a registration statement with the SEC registering the resale of the ordinary shares, including the ordinary shares underlying the warrants, issued as part of the Offering.

Taking into account cash and cash equivalents of $103.2 million as of June 2025 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 the second quarter of 2026.

To properly account for pre-funded warrants under US GAAP, an issuer must first apply ASC 480 – Distinguishing liabilities from equity, and then from ASC 815 – Derivatives and Hedging

ASC 480 – DISTINGUISHING LIABILITIES FROM EQUITY

Under ASC480–10–25, a financial instrument should be classified as liability if :

(i) It is mandatorily redeemable,

(ii) It represents an unconditional obligation to repurchase the issuer’s equity shares,

(i) It requires the issuer to deliver a variable number of share or net cash settlement.

In our view, April 2025 prefunded warrants avoid all ASC 480 triggers as they meet the following conditions :

(i) Freestanding and detachable : they are legally separable from other instruments,

(ii) Fixed exercise terms : they entitle the holder to a fixed number of shares upon exercise,

(iii) No redemption obligations : they do not require the issuer to transfer cash to repurchase shares.

ASC 815 – DERIVATIVES AND HEDGING

ASC 815 – 40 – Contracts in Entity’s Own Equity addresses whether an equity-linked contract, qualifies as equity in the entity’s financial statements.

Indexation to the Company’s own stock

The first condition that must be met for an equity-linked instrument to qualify as equity is to be considered indexed to the entity’s own stock in accordance with ASC 815-40-15.

To determine whether an equity-linked instrument is indexed to the Entity’s own stock, a 2-step analysis must be performed:

Step 1 – Evaluate whether the instrument contains any exercise contingencies, and, if so, whether they disqualify the instrument from being classified as equity,

Step 2 – Assess whether the settlement terms are consistent with equity classification.

Based on the above elements Prefunded warrants are to be indexed to the Company ‘s stock.

Equity classification

As Pre-Funded warrants require a settlement in shares (physical settlement) and neither give rise to a net-cash settlement nor provide the option of settlement in shares or net-cash settlement, they shall be initially classified as equity.

Other conditions necessary for equity classification are met:

  1. The Company has sufficient authorized and unissued shares available to settle the contract after considering all other commitments that may require the issuance of stock during the maximum period the warrants could remain outstanding.

  2. The contract contains an explicit limit on the number of shares (1 share per First Prefunded warrant and up to 71,005,656 in total and 1.75 share per Second Prefunded warrant and up to 124,259,898 in total) to be delivered in a share settlement. Adjustments to the exercise ratio are subject to the occurrence of specific events and result from the application of determined formulas.

  3. There is no required cash payment if DBV S.A. fails to timely file. There is no requirement to net cash settle the contract in the event the entity fails to make timely filings with the Securities and Exchange Commission (SEC).

  4. There are no cash settled top-off or make-whole provisions.

April 2025 Prefunded warrants can be classified as equity and shall be accounted for in permanent equity. Subsequent changes in fair value shall not be recognized as long as they continue to be classified as equity.

Legal Proceedings

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

Note 3: Cash and Cash Equivalents

The following tables summarize the cash and cash equivalents as of June 30, 2025 and December 31, 2024:

June 30, 2025December 31, 2024
Cash29,37132,456
Cash equivalents73,836—
Total cash and cash equivalents as reported in the statements of financial position103,20732,456

Cash equivalents are convertible into cash on 32 days notice 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:

June 30, 2025December 31, 2024
Research tax credit2,3783,980
Other tax claims10,4284,452
Prepaid expenses2,3431,541
Other receivables2,8851,959
Total18,03411,932

Research tax credit

The variance in Research Tax Credit is presented as follows:

Amount in thousands of US dollars
Opening research tax credit receivable as of January 1, 20253,980
+ Operating revenue2,217
- Payment received(4,186)
- Adjustement and currency translation effect367
Closing research tax credit receivable as of June 30, 20252,378
Of which - Non-current portion—
Of which - Current portion2,378

The estimated research tax credit for the first six months of the 2025 fiscal year amounts to $2.2 million.

The other tax claims are primarily related to the VAT as well as the reimbursement of VAT that has been requested. Prepaid expenses are comprised primarily of insurance expenses, as well as legal and scientific consulting fees.

Note 5: Lease contracts

Future minimum lease payments under the Company’s operating leases’ right of use as of June 30, 2025 and December 31, 2024, are as follows:

June 30, 2025 · December 31, 2024
Real Estate · Other assets · Total · Real Estate · Other assets · Total
Current portion1,287771,36581026836
Year 21,336421,3781,22271,228
Year 31,34571,3521,23071,237
Thereafter5,01755,0225,12795,136
Total minimum lease payments8,9861319,1178,388498,437
Less: Effects of discounting(1,415)(7)(1,422)(1,463)(23)(1,486)
Present value of lease liabilities7,5711247,6956,925266,951
Less: current portion(926)(72)(998)(648)(6)(654)
Long-term lease liabilities6,645516,6966,278206,297
Weighted average remaining lease term (years)7.170.037.490.02
Weighted average discount rate5.13%0.08%5.02%0.02%

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:

June 30,
20252024
Operating lease expense / (income)5621,255
Net termination impact(70)
Net restructuring impact(26)

Supplemental cash flow information related to operating leases is as follows for the period June 30, 2025 and 2024:

June 30,
20252024
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows used in operating leases1801,019

Note 6: Trade Payables and Other Liabilities

6.1 Trade Payables

Trade payables increased by $18.8 million as of June 30, 2025, compared to December 31, 2024, reflecting the increase in clinical trials spent and manufacturing.

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 period presented.

6.2 Other Liabilities

The following tables summarize the other liabilities as of June 30, 2025 and December 31, 2024:

June 30, 2025 · December 31, 2024
Other current liabilities · Other non-current liabilities · Total · Other current liabilities · Other non-current liabilities · Total
Employee related liabilities6,293—6,2937,294—7,294
Tax liabilities625—625188—188
Other debts600—600846—846
Total7,518—7,5188,328—8,328

The Employee related liabilities include short-term debt to employees including social welfare, tax agency obligations and bonus provision. The variance versus year end is due to bonus accruals.

Note 7: Shareholders’ equity

The share capital as of June 30, 2025 is set at the sum of €13,697,370 ( $15,393 thousands converted to USD at historical rates). It is divided into 136,973,697 fully authorized, subscribed and paid-up ordinary shares with a par value of €0.10.

Pursuant to the authorizations granted by the Combined General Meeting of Shareholders of June 11, 2025, DBV Technologies S.A.'s net income for the year ended December 31, 2024 was allocated to retained earnings, leaving a debit balance of 102,284,799.30 euros.

The share premium account was cleared and its full amount (35,154,861.25 euros) was charged, leaving a debit balance of 67,129,938.05 euros on the retained earnings account.

Pursuant to the delegations of authority granted by the Combined General Meeting of Shareholders of May 16, 2024 (“the 2024 Meeting”) under the terms of the 24th and 30th resolutions of the 2024 Meeting, the Board of Directors of the Company (“the Board”), at its meeting of March 27, 2025, for a maximum nominal amount of 28,929,000:

noted that the offering would consist of a capital increase with cancellation of preferential subscription rights, reserved exclusively for the beneficiaries defined in the 24th resolution of the 2024 Meeting, by way of an issue of:

–ordinary shares (the “New Shares”) each with warrants attached (the “ABSA Warrants”, and together with the New Shares, the “ABSA”) to subscribe to 1.75 ordinary shares (the “ABSA Warrant Shares”); and

–units (the “PFW-BS-PFW”) consisting of (i)one pre-funded warrant (each a “First Pre-Funded Warrant”) giving the right, in the event of exercise, to 1 ordinary share of the Company (each a “First PFW Share”) and (ii)1 warrant (each a “BS Warrant”) to purchase 1 pre-funded warrant (each a “Second Pre-Funded Warrant”) giving the right, in the event of exercise, to 1.75 ordinary shares of the Company (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”).

decided on the principle of:

–a capital increase in cash with cancellation of the shareholders' preferential subscription right by way of an offer reserved to certain categories of investors by the issuance of ABSA;

–issuing PFW-BS-PFW with cancellation of the shareholders' preferential subscription right by way of an offer reserved to certain categories of investors;

– one or more capital increase(s) in cash with cancellation of the shareholders' preferential subscription right for the benefit of the holders of ABSA Warrants, First Pre-Funded Warrants, BS Warrants and Second Pre-Funded Warrants.

granted a number of authorizations for the purpose of carrying out the capital increase(s);

sub-delegated its authority to the Chief Executive Officer for the purpose of implementing the financing and record the final completion of the capital increase in respect of the New Shares and of all capital increases in respect of the Warrant Shares.

On March 27, 2025, acting under the sub-delegation granted to it by the Board in its decisions of March 27, 2025, and after having noted that the volume average price of the Company’s shares on Euronext Paris, calculated over 5 consecutive trading sessions out of the last 30 trading sessions preceding the setting of the price (i.e. the sessions of March 13, 14, 17, 18 and 19, 2025 is 0.8989 euro (the “Reference Share Price”) and the Reference Share Price less a 15% discount is equal to 0.7641 euro, the Chief Executive Officer :

decided consequently to set the price of each ABSA at 1.1136 euros, corresponding to a premium of 23.89% compared to the Reference Share Price (the “ABSA Price”);

decided that the issue price of each PFW-BS-PFW is equal to the ABSA Price and corresponds to the price of the First Pre-Funded Warrants to be paid up on the date of issue of the PFW-BS-PFW and to the balance of the exercise price of the First Pre-Funded Warrants equal to 0.01 euro per First Pre-Funded Warrant;

decided, making use of the 24th resolution of the 2024 General Meeting, in accordance with Article L.225-138 of the French Commercial Code, to

(i) increase the share capital of the Company in cash through the issuance, sale and delivery of 34,090,004 ABSA to be subscribed for at a subscription price of 1.1136 euros per ABSA (i.e.0.10 par value and 1.0136 euros of issue premium), with cancellation of the shareholders' preferential subscription right within the framework of the Offering, to be fully paid up at the time of subscription, i.e. a capital increase of a nominal amount of 3,409,000.40 euros, and

(ii) issue, sale and deliver 71,005,656 PFW-BS-PFW at an aggregate price of 1.1136 euros per PFW-BS-PFW with cancellation of the shareholders' preferential subscription right within the framework of the Offering, to be fully paid up at the time of subscription;

On April 07, 2025, the Chief Executive Officer noted: (i) that the 34,090,004 new ordinary shares with a nominal amount of €0.10 have been fully subscribed and fully paid up, (ii) the final completion of the capital increase, and (iii) the share capital of the Company has consequently been increased from €10,285,886.80, divided into 102,858,868 shares, to €13,694,887.20, divided into 136,948,872 shares with a nominal value of €0.10.

Note 8: Share-Based Payments

The Board of Directors has been authorized at 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”).

During the three months ended June 30, 2025, the Company granted 215,000 stock options and 35,000 restricted stock units toone employee.

There have been no changes in the vesting conditions and method of valuation of the SO and RSUs from that disclosed in Note 12 to the consolidated financial statements included in the Annual Report.

Change in Number of BSA/SO/RSU:

Number of outstanding
BSA · SO · RSUs
Balance as of December 31, 2024244,69310,452,9032,813,366
Granted during the period—215,00035,000
Forfeited during the period—(66,100)(82,850)
Exercised/released during the period——(36,192)
Expired during the period(49,185)(128,100)—
Balance as of June 30, 2025195,50810,473,7032,729,324

Share-based payments expense reflected in the condensed consolidated statements of operations is as follows:

Three Months Ended June 30, · Six Months Ended June 30,
2025 · 2024 · 2025 · 2024
Research & developmentSO(352)(456)(734)(969)
RSU(191)(241)(390)(497)
Sales & marketingSO(13)(20)(25)(43)
RSU(6)(9)(12)(18)
General & administrativeSO(597)(700)(1,594)(1,730)
RSU(86)(100)(192)(226)
Total share-based compensation (expense)(1,246)(1,525)(2,947)(3,483)

Note 9: Contingencies

The following tables summarize the contingencies as of June 30, 2025 and December 31, 2024:

June 30, 2025December 31, 2024
Current contingencies117122
Non-current contingencies1,084838
Total contingencies1,201961

The changes in contingencies are as follows:

Pension retirement obligationsOther contingenciesTotal
At January 1, 2025838122961
Increases in liabilities70109179
Used liabilities—(126)(126)
Actuarial gains and losses on defined-benefit plans44—44
Currency translation effect13211143
At June 30, 20251,0841171,201
Of which current—117117
Of which non-current1,084—1,084

The Company does not hold any plan assets related to long-term employee benefit for any of the periods presented. There have been no significant changes in assumptions for the estimation of the retirement commitments from those disclosed in Note 13 to the consolidated financial statements included in the Annual Report.

Note 10: Operating income

The following table summarizes the operating income during the three and six months ended June 30, 2025 and 2024:

Three Months Ended June 30, · Six Months Ended June 30,
2025 · 2024 · 2025 · 2024
Research tax credit1,4651,1612,2172,568
Total1,4651,1612,2172,568

The decrease in Research tax credit during the six months ended June 30, 2025 was primarily due to the fact that a greater proportion of clinical studies activities were carried out in North America and were therefore not eligible to the French Research tax credit in 2025 compared to 2024, whereas the increase in Research tax credit during the three months ended June 30, 2025 was primarily due to the fact that more eligible activities have been carried out in the period, in particular with the launch of COMFORT Toddlers clinical trial explaining the increase of the research tax credit on a 3 months basis compared to a decrease on a 6 months basis.

Note 11: Operating Expenses

The Company had an average of 109 employees during the six months ended June 30, 2025, in comparison with an average of 106 employees during the six months ended June 30, 2024. The increase is mainly due to hiring to support development activities and quality activities.

The following table summarizes the allocation of personnel expenses by function during the six months ended June 30, 2025 and 2024:

Three Months Ended June 30, · Six Months Ended June 30,
2025 · 2024 · 2025 · 2024
Research and Development expenses5,6975,17710,32710,225
Sales & Marketing expenses194233350567
General & Administrative expenses3,9083,4136,9046,650
Total personnel expenses9,7998,82417,58117,442

The following table summarizes the allocation of personnel expenses by nature during the six months ended June 30, 2025 and 2024:

Three Months Ended June 30, · Six Months Ended June 30,
2025 · 2024 · 2025 · 2024
Wages and salaries6,6905,54011,36710,684
Social security contributions1,8271,5153,1972,722
Expenses for pension commitments3624470553
Share-based payments1,2451,5252,9473,483
Total9,7998,82417,58117,442

The increase in personnel expenses is due to (1) recruitments made during the second quarter of 2024 for which personnel costs are recognized for a full period at end-June 2025, and (2) retroactive payment to January 1st of salary increases in the second quarter of 2025.

Note 12: Commitments

There were no significant changes in other commitments from those disclosed in Note 17 to the consolidated financial statements included in the Annual Report.

Note 13: Relationships with Related Parties

There were no changes in the nature of the transactions from those described in Note 18 to the consolidated financial statements included in the Annual Report.

As part of the financing announced in a press release on March 27, 2025, the Company's Board of Directors on March 27, 2025 authorized 3 new transactions with related parties, in accordance with article L 225-38 of the French Commercial Code:

–The signature of a Securities Purchase Agreement between the Company and Baker Brothers Advisors LP, a shareholder of the Company owning a fraction of the voting rights above 10% ;

–The signature of a Securities Purchase Agreement between the Company and BPIfrance Participations SA, a shareholder with a permanent representative at the Company's Board of Directors;

–The signature of a Registration Rights Agreement between the Company and its investors, in particular Baker Brothers Advisors LP and BPIfrance Participations SA.

Note 14: Loss Per Share

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 period. As the Company was in a loss position for each of the six-month periods ended June 30, 2025 and 2024, the diluted loss per share is equal to basic loss per share because the effects of potentially dilutive shares were anti-dilutive as a result of the Company’s net loss.

The following is a summary of the ordinary share equivalents that were excluded from the calculation of diluted net loss per share as of June 30, 2025 and 2024 indicated in number of potential shares:

As of June 30,
20252024
Non-employee warrants195,508244,693
Stock options10,473,7037,535,091
Restricted stock units2,729,3242,188,071
Prefunded warrants127,361,99128,276,331

Note 15: Events after the Close of the Period

None

Note 16: Reportable segment disclosure

Three Months Ended June 30, · Six Months Ended June 30,
2025 · 2024 · 2025 · 2024
Clinical studies16,25813,05623,06021,229
BLA & Regulatory2,2981,6103,6833,090
Medical Affairs & Other Medical2,0091,6263,9674,290
Research & Innovation3425751,086765
Manufacturing & Supply and Quality12,7868,50723,38017,403
Sales & Marketing4199866811,744
General & Administrative8,4638,64314,08916,447
Total expenses42,57535,00369,94664,968

The Company operates and is managed asone operating segment driving expenses for the development of the Viaskin Peanut patch. The Company’s R&D organization is primarily responsible for the development and registration efforts of the Viaskin Peanut patch. 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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