What changed in this filing

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Item 9A. Controls and Procedures

2024-03-07 compared with 2023-03-02 · 381 added, 330 removed, 917 unchanged (44% of the section changed)

5 unchanged sentences

Management’s Report on Internal Control Over Financial Reporting.

Our management is responsible for establishing and maintaining adequate internal controls over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) and for the assessment of the effectiveness of our internal control over financial reporting.

effectiveness of our internal control over financial reporting.

Under the supervision and with the participation of our chief executive officer (principal executive officer) and chief financial officer (principal financial officer), management assessed the effectiveness of our internal control over financial reporting based upon the framework in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements and can only provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements.

Also, projections of any evaluation of effectiveness to future periods are

subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

A deficiency in internal control over financial reporting exists when the design or operation of a control does not allow management or employees, in the normal course of performing their assigned functions, to prevent or detect misstatements on a timely basis.

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Changes in Internal Control over Financial Reporting.

There were no changes to our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the three months ended December 31, 2022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

There were no changes to our internal control over financial reporting identified in connection with the evaluation required by Rule

of the Exchange Act that occurred during the three months ended December 31, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Other Information.

During the fiscal quarter ended December 31, 2023, no ne of our officers or directors, as defined in Rule

adopted, modified or terminated a “Rule

trading arrangement” or a

trading arrangement,” as those terms are defined in Item 408 of Regulation

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.

Not applicable.

Certain information required by Part III is omitted from this report because we will file with the SEC a definitive proxy statement pursuant to Regulation 14A, the Proxy Statement, no later than 120 days after the end of our fiscal year, and certain information included therein is incorporated herein by reference.

Directors, Executive Officers and Corporate Governance.

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Incorporated by Reference

By-laws ( statuts ) of the registrant (English translation)

By-laws ( status ) of the registrant (English translation)

Form of Deposit Agreement

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Office Lease between the registrant and GENERALI VIE, dated March 3, 2025 (English translation)

Office Lease between the registrant and SCI DANTON MALAKOFF, dated October 2, 2023 (English translation)

Lease Agreement between DBV Technologies Inc.

and SIG 106 LLC, dated March 28, 2022

Assignment, Development and Co-Ownership Agreement among the registrant, L’Assistance Publique—Hopitaux de Paris and Université Paris Descartes, dated January 7, 2009 (English translation)

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Amendment to Development Collaboration and License Agreement between the registrant and NESTEC S.A., dated July 12, 208

Letter Agreement Terminating Development Collaboration and License Agreement between registrant and Société des Produits Nestlé S.A.

(f/k/a NESTEC S.A.), dated October 26, 2023

Form of Indemnification Agreement between the registrant and each of its executive officers and directors

2013 and 2014 Share Option Plans (English translation)

Incorporated by Reference

2012, 2013 and 2014 Free Share Plans (English translation)

3 unchanged sentences

2015 Free Share Plans (English translation)

Incorporated by Reference

2016 Share Option Plan (English translation)

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2019 Share Option Plan (English translation)

2019 Free Share Plans (English translation)

2020 Stock Option Plan (English translation)

2019 Free Share Plan (English translation)

2021 Stock Option Plan (English translation)

2020 Share Option Plan (English translation)

2020 Free Share Plan (English translation)

2022 Stock Option Plan (English translation)

2021 Share Option Plan (English translation)

2021 Free Share Plan (English translation)

Executive Agreement, dated November 29, 2018, between the registrant and Daniel Tassé

2022 Share Option Plan (English translation)

2022 Free Share Plan (English translation)

2023 Share Option Plan (English translation)

2023 Free Share Plan (English translation)

Executive Agreement, dated November 29, 2018, between the registration and Daniel Tassé

First Amendment to the Executive Agreement of Daniel Tassé, dated June 27, 2019, between the registrant and Daniel Tassé

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Letter Agreement, dated June 26, 2019, between the registrant and Sébastien Robitaille (English translation)

Letter Agreement, dated December 1, 2020, between the registrant and Se´bastien Robitaille (English translation)

Letter Agreement, dated December 1, 2020, between the registrant and Sébastien Robitaille (English translation)

Incorporated by Reference

English Summary Translation of Separation Agreement and Release between Sébastien Robitaille and registrant

Letter Agreement, dated November 1, 2023, between the registrant and Virginie Boucinha (English translation)

List of subsidiaries of the registrant

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Certification by the Principal Executive Officer pursuant to Securities Exchange Act Rules 13a- 14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

Incorporated by Reference

Certification by the Principal Financial Officer pursuant to Securities Exchange Act Rules 13a- 14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

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Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

Incentive Compensation Recoupment Policy, approved

Inline XBRL Instance Document

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March 7, 2024

Each person whose individual signature appears below hereby authorizes and appoints Daniel Tassé and Sebastien Robitaille, and each of them, with full power of substitution and resubstitution and full power to act without the other, as his or her true and lawful attorney-in-fact and agent to act in his or her name, place and stead and to execute in the name and on behalf of each person, individually and in each capacity stated below, and to file any and all amendments to this report on Form 10-K, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing, ratifying and confirming all that said attorneys-in-fact and agents or any of them or their or his substitute or substitutes may lawfully do or cause to be done by virtue thereof.

Each person whose individual signature appears below hereby authorizes and appoints Daniel Tassé and Virginie Boucinha, and each of them, with full power of substitution and resubstitution and full power to act without the other, as his or her true and lawful attorney-in-fact and agent to act in his or her name, place and stead and to execute in the name and on behalf of each person, individually and in each capacity stated below, and to file any and all amendments to this report on Form 10-K, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing, ratifying and confirming all that said attorneys-in-fact and agents or any of them or their or his substitute or substitutes may lawfully do or cause to be done by virtue thereof.

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this report on Form 10-K has been signed below by the following persons on behalf of the Registrant in the capacities indicated on March 7, 2024.

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( Principal Executive Officer )

/s/ Sebastién Robitaille

Sebastién Robitaille

/s/ Virginie Boucinha

Virginie Boucinha

Chief Financial Officer

8 unchanged sentences

/s/ Timothy E.

/s/ Adora Ndu

/s/ Julie O’Neill

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Consolidated Statements of Cash Flows for the Years Ended December 31, 2023 and 2022

Consolidated Statements of Changes in Shareholders’ Equity for the Years Ended December 31, 2022

Consolidated Statements of Changes in Shareholders’ Equity for the Years Ended December 31, 2023 and 2022

Notes to the Consolidated Financial Statements

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We have audited the accompanying consolidated statements of financial position of DBV Technologies S.A.

and subsidiaries (the “Company”) as of December 31, 2022 and 2021, the related consolidated statements of operations and comprehensive loss, cash flows and changes in shareholders’ equity for each of the years in the two-year period ended December 31, 2022, and the related notes (collectively referred to as the “consolidated financial statements”).

In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for each of the years in the two-year period ended December 31, 2022, in conformity with accounting principles generally accepted in the United States of America.

and subsidiaries (the “Company”) as of December 31, 2023 and 2022, the related consolidated statements of operations and comprehensive loss, cash flows and changes in shareholders’ equity for each of the two years in the period ended December 31, 2023, and the related notes (collectively referred to as the “consolidated financial statements”).

In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2023, in conformity with accounting principles generally accepted in the United States of America.

Going Concern

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern.

As discussed in Note 1 to the consolidated financial statements, the Company has incurred operating losses and negative cash flows from operations since inception and current cash and cash equivalents are not sufficient for at least the next twelve months.

These matters raise substantial doubt about the ability of the Company to continue as a going concern.

Management’s plans in regard to these matters are described in Note 1.

The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

This matter is also described in the “Critical Audit Matter” section of our report.

Basis for Opinion

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We believe that our audits provide a reasonable basis for our opinion.

Critical Audit Matters

The critical audit matters communicated below are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that (1) relate to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments.

The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.

Pre-funded warrants—Refer to Note 11 to the consolidated financial statements

Critical Audit Matter Description

As described in Note 11 to the consolidated financial statements, the Company proceeded with a capital increase in cash with cancellation of preferential subscription rights reserved for categories of investors, an amount of €3,285,566.90, through the issuance of (i) 32,855,669 new ordinary shares at a price per ordinary share of €3.00 (corresponding to $3.22) including a €2.90 share premium and (ii) prefunded warrants to purchase 28,276,331 new ordinary shares 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.

The Company determined that the pre-funded warrants are freestanding instruments that meet the criteria for classification as equity.

We identified the assessment of the accounting classification of the pre-funded warrants issued during the year as a critical audit matter.

The accounting requirements related to the classification of financial instruments as debt or equity are complex.

A slight variation in the interpretation of terms and conditions of the pre-funded warrants could result in the pre-funded warrants being classified as a liability, which would also impact the statement of operations, as the subsequent accounting for pre-funded warrants treated as liabilities is significantly different from those classified as equity.

This matter required a high degree of auditor judgment to analyze the terms and conditions of the pre-funded warrants agreement to ensure management’s interpretation of the relevant terms and conditions of the pre-funded warrants agreement led to an appropriate application of the accounting standards.

How the Critical Audit Matter was Addressed in the Audit

The audit procedure we performed to address this critical audit matter included the following:

reading the pre-funded warrant agreement and the Company’s analysis and comparing our interpretation of the terms and conditions of the warrant agreement with the analysis performed by management.

Income and provision for loss at completion - Contract with Nestlé Health Science — Refer to Notes 13 and 14 to the consolidated financial statements

Critical Audit Matter

The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee

(1) relates to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments.

The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.

Going Concern – Refer to Note 1 to the consolidated financial statements

Critical Audit Matter Description

As described further in Notes 13 and 14 to the consolidated financial statements, on May 31, 2016, the Company entered into an exclusive global collaboration agreement with Nestlé Health Science to develop MAG1C, a ready-to-use and standardized atopy patch test tool for the diagnosis of cow’s milk protein allergy in infants and toddlers.

Under the terms of the exclusive collaboration, the Company is responsible for leading the development activities of MAG1C up through a pivotal Phase III clinical program.

As described in Note 1, the Company recognizes income under the percentage-of-completion method, and periodically updates its measurement of progress and its cumulative income accordingly.

The Company uses

costs incurred as the input method to determine progress.

The Company accrues for any excess between costs yet to be incurred and income yet to be recognized for the completion of the performance obligations.

As a consequence, the accounting for this contract involves estimates related to evaluation of costs to be incurred and the determination of the timeline for the Phase II clinical trial and Phase III clinical program.

As of December 31, 2022, the Company recorded its collaboration agreement’s revenues based on its updated measurement of progress of the Phase II clinical trial conducted as part of the agreement.

Given the Company has experienced difficulties in enrolling new patients in this Phase II clinical trial, the Company expects to incur additional clinical and production costs related to the Phase II clinical trial as well as delays in achievement of upcoming milestones.

As a result, revenues were reversed for an amount of $874 thousand and a loss provision of $19,835 thousand was recorded for the year-then-ended.

We identified the evaluation of the costs to be incurred and estimated loss at completion for the collaboration agreement with Nestlé Health Science as a critical audit matter.

Given estimates are necessary to determine total costs to complete for each clinical phase and milestone of the collaboration agreement, auditing such estimates required complex audit judgment to evaluate the estimated costs to achieve the performance obligations.

As described further in Note 1 to the consolidated financial statements, 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.

The Company cannot guarantee that it will be able to obtain the necessary financing to meet its needs or to obtain funds at attractive terms and conditions.

The Company’s available cash and cash equivalents are not sufficient to support its operating plan for at least the next twelve months from the issuance date of these consolidated financial statements.

As such, substantial doubt exists regarding the Company’s ability to continue as a going concern.

We identified the evaluation of the Company’s ability to continue as a going concern and related disclosures as a critical audit matter.

This matter required a high degree of auditor judgment and increased effort when performing audit procedures to evaluate (1) the reasonableness of management’s forecasted operating expenses, and (2) the adequacy of the consolidated financial statements disclosure related to the going concern assessment.

How the Critical Audit Matter was Addressed in the Audit

The primary audit procedures we performed to address this critical audit matter included the following:

We compared the transaction prices to the consideration expected to be received based on the milestones defined within the collaboration agreement and any amendment or modification that were agreed to with Nestlé Health Science.

For a selection of transactions, we tested the accuracy of costs actually incurred for the collaboration agreement in the current year by agreeing the amounts to invoices.

We evaluated the estimate of total costs to be incurred by:

Evaluating the global timeline of the clinical study defined by management as part of their budget process to assess if it is consistent with the external assumptions from the Contract Research Organization (CRO) as related to the recruitment of patients.

Evaluating the estimates prepared by management to assess if they are consistent with the approved cash trajectory and budget approved by the Company’s Board of Directors.

Performing a look-back analysis by comparing prior year costs to be incurred estimated by management to the actual prior year costs recorded by the Company to identify potential management bias.

Evaluating management’s ability to achieve the estimate of total costs and profit or loss by performing inquiries with the Company’s project manager.

We evaluated the design of the internal control related to the Company’s going concern assessment;

We evaluated the reasonableness of the Company’s forecasted operating expenses by inquiring of senior management to gain an understanding of the Company’s operations, strategy, and research and development activities, compared the forecasted operating expenses to historical operating expenses and challenged expected costs, especially those costs that relate to future clinical trials;

We assessed management’s ability to forecast operating expenses and cash flows by comparing prior year forecasts to actual financial results;

We assessed the adequacy of the consolidated financial statements’ disclosure related to the going concern assessment by comparing it to the audit evidence obtained.

/s/ Deloitte & Associés

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Property, plant, and equipment, net

assets related to operating leases

Right-of-use assets related to operating leases

Intangible assets

Other non-current

Total non-current

Other non-current assets

Total non-current assets

Liabilities and shareholders’ equity

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Long-term financial debt

contingencies

Other non-current

Total non-current

Non-current contingencies

Other non-current liabilities

Total non-current liabilities

Total liabilities

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Ordinary shares, € 0.10 par value;

94,137,145 and 55,095,762 shares authorized, and issued as at December 31, 2022 and 2021, respectively

Additional paid-in

Treasury stock, 149,793 and 153,631 ordinary shares as of December 31, 2022 and 2021, respectively, at cost

96,431,770 and 94,137,145 shares authorized, and issued as at December 31,

2023 and 2022, respectively

Additional paid-in capital

Treasury stock,

222,988 and 149,793 ordinary shares as of December 31, 2023 and 2022, respectively, at cost

Accumulated deficit

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General & administrative expenses

Restructuring reversal (expenses)

Total Operating expenses

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(Decrease) increase in trade payables

(Decrease) increase in other current and non-current

(Decrease) increase in other current and non-current liabilities

Change in operating lease liabilities and right of use assets

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Acquisitions of intangible assets

Acquisitions of non-current

financial assets

Acquisitions of non-current financial assets

Proceeds from non-current

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comprehensive

Balance at January 1, 2021

Balance at December 31, 2021

Other comprehensive (loss)

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Allocation of accumulated net losses

Other change in equity

Balance at December 31, 2022

Other comprehensive (loss)

Other comprehensive income (loss)

Issuance of ordinary shares

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The share capital of this French subsidiary is 100 % owned by DBV Technologies S.A.

On December 31, 2021, the company proceeded to the dissolution of DBV Canada Ltd.

This subsidiary was originally incorporated in Ottawa, Ontario on August 13, 2018 (the “Canadian subsidiary”).

The share capital of this Canadian subsidiary was 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.

dollars, which differs from the functional

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.

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At period-end,

foreign currency monetary assets and liabilities are converted at the rate of exchange prevailing on that date.

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 entity individual statements of operations in “Financial income (expense)”;

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The Company bases its estimates and assumptions on historical experience and other factors that it believes to be reasonable under the circumstances.

As of December 31, 2022, the ongoing pandemic may make management’s estimates vulnerable to significant changes.

Those uncertainties were considered in the assumptions underlying the estimates and judgments used by the Company but a number of estimates have been and will continue to be affected by the ongoing pandemic.

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) evaluation of costs and measure of progress of the development activities conducted as part of the collaboration agreement with Nestlé Health Science, (2) research tax credits, (3) assumptions used in the valuation of right-of-use

(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 contingencies.

Going concern

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The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business.

However, substantial doubt about the Company’s ability to continue as a going concern exists.

Since its inception, the Company has primarily funded its operations with equity financings, and, to a lesser extent, public assistance aimed at supporting innovation and payments associated with research tax credits (Crédit d’Impôt Recherche).

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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 and announced its plan to initiate a pivotal Phase 3 clinical study for a modified Viaskin Peanut patch (mVP) in children in the intended patient population.

The Company considers this approach as the most straightforward approach to demonstrate effectiveness, safety, and improved in vivo adhesion of the modified Viaskin Peanut system.

The Company considers this approach as the most straightforward approach to demonstrate effectiveness, safety,

and improved in vivo adhesion of the modified Viaskin Peanut system.

After receiving approval from the FDA for its change in strategy, the protocol for the new Phase 3 pivotal study of the modified Viaskin Peanut (“mVP”) patch was completed at the end of February 2022 and has been prepared for FDA submission.

In May 2022, the Company established an At-The-Market

(“ATM”) program allowing to offer and sell, including with unsolicited investors who have expressed an interest, a total gross amount of up to $ 100 million of American Depositary Shares (“ADSs”).

In May 2022, the Company established an At-The-Market (“ATM”) program allowing to offer and sell, including with unsolicited investors who have expressed an interest, a total gross amount of up to $ 100 million of American Depositary Shares (“ADSs”).

The Company’s intent is to use the net proceeds, if any, of sales of ADSs issued under the program, together with its existing cash and cash equivalents, primarily for activities associated with potential approval and launch of Viaskin Peanut, as well as to advance the development of the Company’s product candidates using its Viaskin Platform and for working capital and other general corporate purposes.

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The Company indicated the updated protocol will be submitted to study sites for subsequent Institutional Review Boards and Ethics Committees approval.

Based on its current operations, plans and assumptions as revised pursuant to 2022 announcements related to EPITOPE P

hase 3 study topline results and VITESSE P

hase 3 partial clinical hold lift, as well as ATM and PIPE financings, the Company expects that its balance of cash and cash equivalents of $ 209.2 million as of December 31, 202 2

will be sufficient to fund its operations for at least the next 12 months.

The company has incurred operating losses and negative cash flows from operations since inception.

As of the date of the filing, the Company’s available cash and cash equivalents are not projected to be sufficient to support its operating plan for at least the next 12 months.

As such, there is substantial doubt regarding the Company’s ability to continue as a going concern.

Based on our current operations, as well as our plans and assumptions, we expect that our balance of cash and cash equivalents of

$ 141,4 million as of December 31, 2023 will be sufficient to fund our operations until December 31,

The Company intends to seek additional capital as it prepares for the launch of Viaskin Peanut, if approved, and continues other research and development efforts.

The Company will require substantial additional capital to fund its research and development and ongoing operating expenses.

These capital requirements are expected to be funded through debt and equity offerings prior until December 31, 2024.

The Company may seek to finance its future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of non-dilutive

The Company cannot guarantee that it will be able to obtain the necessary financing to meet its needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets due to the ongoing COVID-19

pandemic and conflict in Ukraine.

The ongoing COVID-19

pandemic and conflict in Ukraine have already caused extreme volatility and disruptions in the capital and credit markets.

pandemic and conflict in Ukraine caused extreme volatility and disruptions in the capital and credit markets.

A severe or prolonged economic downturn could result in a variety of risks to the Company, including reduced ability to raise additional capital when needed or on acceptable terms, if at all.

If the Company is not successful in its financing objectives, the Company could have to scale back its operations, notably by delaying or reducing the scope of its research and development efforts or obtain financing through arrangements with collaborators or others that may require the Company to relinquish rights to its product candidates that the Company might otherwise seek to develop or commercialize independently.

arrangements with collaborators or others that may require the Company to relinquish rights to its product candidates that the Company might otherwise seek to develop or commercialize independently.

These Consolidated Financial Statements do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses that may be necessary if the Company were unable to continue as a going concern.

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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 between one and three years .

Acquired intangible assets are mainly composed of software amortized on a straight-line basis over their estimated useful lives comprised between one

and three 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.

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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 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.

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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,

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.

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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.

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.

1 unchanged sentence

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 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.

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Cash includes cash on hand and demand deposits with banks.

Cash equivalents include short-term, highly liquid investments, with a remaining maturity at the date of purchase of three months or less for which the risk of changes in value is considered to be insignificant.

Cash equivalents include short-term, highly liquid investments, with a short term remaining maturity at the date of purchase or less, refundable within one month, for which the risk of changes in value is considered to be insignificant.

Demand deposits therefore meet the definition of cash equivalents.

1 unchanged sentence

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.

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.

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

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Research Tax Credit

The Research Tax Credit (

Crédit d’Impôt Recherche

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.

1 unchanged sentence

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

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, 2022, the Company received the reimbursement of

million of the 2019, 2020 and 2021 fiscal year research tax credit.

$ 26.1 millions of the 2019, 2020 and 2021 fiscal year research tax credit.

During the year ended December 31, 2023, the Company received the reimbursement of $ 5.9 millions of the 2022 fiscal year research tax credit.

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.

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.

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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.

The Company recognizes income under the percentage-of-completion

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 updates its measurement of progress and updates its cumulative income recognized accordingly.

The Company accrues for any excess between costs yet to be incurred and income yet to be recognized for the completion of the performance obligations.

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”.

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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.

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.

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.

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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.

The company has also establish ed 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.

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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.

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.

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Accounting Pronouncements adopted in 2023

The Company has not adopted any new accounting pronouncements in 2022 to date.

Accounting Pronouncements issued not yet adopted

In June 2016, the FASB issued ASU 2016-13—Financial

In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-13—Financial

Instruments—Credit losses, which replaces the incurred loss impairment methodology for financial instruments in current U.S.

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The guidance must be adopted using a modified-retrospective approach and a prospective transition approach is required for debt securities for which an other-than-temporary impairment had been recognized before the effective date.

The Company is currently evaluating the impact of the guidance on its Consolidated Financial Statements.

The Company does not expect that this new standard will have a material impact on its consolidated financial statements.

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.

Adoption of this new standard did not have a material impact on the consolidated financial statements.

In October 2021, the FASB issued ASU 2021-08,

which amends ASC 805 to require acquiring entities to apply Topic 606 to recognize and measure contract assets and contract liabilities in a business combination.

This amendment is effective for public business entities for the fiscal years beginning after December 15, 2022, including interim periods within those fiscal years.

Adoption of this new standard has no impact on the consolidated financial statements.

Accounting Pronouncements issued not yet adopted

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

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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.

g (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

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

Generate the 6-month

safety and adhesion clinical data FDA requested via STAMP, which the Company expected to be the longest component of the mVP clinical plan.

Generate the 6-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.

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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 the two patches, and allotted time to generate informative data through two additional Phase 1

clinical trials in healthy adult volunteers:

PREQUAL, a Phase

trial with adult healthy volunteers to optimize the allergen sample collection methodologies and validate the assays we intend to use in EQUAL.

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.

‘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 of five modified Viaskin Peanut patches .

‘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 of five modified Viaskin Peanut patches .

The Company completed CHAMP in the second quarter of 2021.

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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.

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 improved in 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

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.

European Union Regulatory History and Current Status

On August 2, 2021, the Company announced it has received from the EMA the Day 180 list of outstanding issues, which is an established part of the prescribed EMA review process.

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 the two 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.

The COMFORT Children safety study will enroll peanut allergic children ages 4 – 7-years and will support the efficacy results anticipated from the ongoing VITESSE Phase 3 pivotal study.

FDA agreed with a 6-month study duration and a 3:1 randomization (active:placebo) of approximately 400 subjects in the double-blind, placebo-controlled COMFORT Toddlers study.

The Company expects both COMFORT studies will assess adhesion using the same tools and measurements that were established in VITESSE.

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.

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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 has withdrawn the MAA for Viaskin Peanut and formally notified the EMA of our decision.

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 CHMP 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 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.

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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

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

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)/Ethics Committee (EC) approval.

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.

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The FDA stated that VITESSE may proceed with the revised trial protocol.

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 euro based on the USD/EUR exchange rate of

1.0531 dollar for

1 euro, as published by the European Central Bank on May

2022) and each ADS giving the right to receive

one ordinary share of the Company.

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 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

Gross proceeds from the PIPE financing total approximately $ 194 million (corresponding to € 181 million), before deducting private placement expenses.

The ordinary shares, including the ordinary shares issuable upon exercise of the pre-funded

warrants from the PIPE financing, have not been registered under the Securities Act of 1933, as amended, 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 resal

e of 59,269,629 ordinary shares issued in the PIPE financing, including ordinary shares underlying the pre-funded

On March 11, 2020, the World Health Organization declared COVID-19

During the COVID-19 pandemic, the Company experienced a decrease in new patients enrolling in the ongoing clinical studies and had to adapt the protocols of its clinical trials because patients were subject to travel restrictions and other containment measures.

The Company has continued to assess the impact of the COVID-19 pandemic and uncertainties created by the pandemic on our business and the conduct of our clinical.

As of December 31, 2022, those uncertainties were taken into account in the assumptions underlying the estimates and judgments used by the Company.

The Company continues to update these estimates and assumptions as the situation evolves.

The effects of the

pandemic are presented in the relevant line items of the Consolidated Statement of Financial Position and the Consolidated Statement of Operations and Comprehensive Loss according to the function or nature of the income or expense.

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

Screening of the last patient is anticipated by Q3 2024.

Supplemental Safety Study in children ages 4-7 years with peanut allergy

In 2024, we plan to initiate a six-month supplemental safety study (COMFORT Children) in peanut-allergic children ages 4-7

The additional safety data

generated by this

study will supplement the safety data generated by the VITESSE trial, resulting in a safety database comprised of approximately

600 children ages 4 to 7 years treated with Viaskin Peanut.

This study is expected to be similar to the REALISE (REAL Life Use and Safety of EPIT) safety study that we previously conducted with Viaskin Peanut in children ages 4 to 11 years.

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 millions (Other Operating Income);

Deferred revenue accrual reversal $ 6.9 millions (Operating Expenses);

Accrual for ongoing Clinical study completion $ 2.3 millions (Operating Expenses).

This accrual represents our best estimate of the remainder expenses related to the ongoing clinical study which will be incurred after December 31, 2023 and until the end of the study.

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 millions

($ 14.1 millions

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 euro 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 millions on June 14, 2023 (and a net amount of $ 6.9 millions after $ 0.9 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

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 millions

(corresponding to € 181 millions

), 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, werenot 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.

ordinary shares issued in the June 2022 PIPE, including ordinary shares underlying the pre-funded

Legal Proceedings

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We are not currently subject to any material legal proceedings.

Class Action Complaint Dismissal

A class action complaint was filed on January 15, 2019 in the United States District Court for the District of New Jersey, entitled Travis Ito-Stone

DBV Technologies, et al., Case No.

2:19-cv-00525.

The complaint, as amended, alleged that the Company and its former Chief Executive Officer, its current Chief Executive Officer, its former Deputy Chief Executive Officer, and its former Chief Business officer violated certain federal securities laws, specifically under Sections 10(b) and 20(a) of the Exchange Act, and Rule 10b-5

promulgated thereunder.

The plaintiffs seek unspecified damages on behalf of a purported class of persons that purchased the Company’s securities between February 14, 2018 and August 4, 2020 and also held the Company’s securities on December 20, 2018 and/or March 16, 2020 and/or August 4, 2020.

A hearing was held on July 29, 2021 in the U.S.

District Court for the District of New Jersey where the Court entered an order granting the Company’s Motion to Dismiss the Second Amended Class Action Complaint without prejudice.

As the dismissal was without prejudice, the Plaintiffs replead their case by filing a Third Amended Class Action Complaint on September 30, 2021 in the same Court.

The company moved to dismiss third amended complaint on December 10, 2021.

On July 29, 2022, the Court entered an order granting the Company’s Motion to Dismiss the Plaintiff’s Third Amended Compliant with prejudice.

The Court indicated that the Third Amended Complaint was deficient in a number of ways, failing to allege a violation of the Securities Exchange Act of 1934, and ordered the matter closed.

Per court procedural rules, the Plaintiffs had 30 days to appeal the dismissal of the Third Amended Complaint.

This Plaintiffs failed to file an appeal of the dismissal of the Third Amended Complaint within the 30-day

period and this matter is resolved with finality.

Note 3 Cash and Cash Equivalents

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

Cash equivalent s

Total cash and cash equivalent s

as reported in statement of financial position

Cash equivalents

Total cash and cash equivalents as reported in statement of financial position

Bank overdrafts

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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, 2022, the Company received the reimbursement of

the 2019, 2020 and 2021 fiscal year research tax credit.

the year ended December 31, 2022, the Company received the reimbursement of

millions of the 2019, 2020 and 2021 fiscal year research tax credit.

During the year ended December 31, 2023, the Company :

received the reimbursement of $ 5.9 millions of the 2022 fiscal year research tax credit ;

made a complementary statement for 2020, 2021 and 2022 fiscal year research tax credit.

A complementary research tax credit has been booked for $ 2.9 millions .

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

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Closing balance sheet receivable as of December 31, 2022

Of which—Non-current

Of which—Non-current portion

Of which—Current portion

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Closing balance sheet receivable as of December 31, 2023

Of which—Non-current

Of which—Non-current portion

Of which—Current portion

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

Note 5 Property, Plant, and Equipment

Property and equipment, net consisted of the following:

Property and equipment, net consisted of the follo wi

Reclassification

Laboratory equipment

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Property, plant, and equipment in progress

Less accumulated amortization and depreciation

Relassification

Less accumulated amort.

Reclassification

Laboratory equipment

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The depreciation and amortization expense for each of the years ended December 31, 2023 and 2022 was $ 3.6 million and $ 2.7 million respectively.

Laboratory equipment increase in 2021 was mainly driven by commissioning of industrial equipment.

Note 6 Lease contracts

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Operating lease expense

Refurbishing impact

Net termination impact

In January 2022, the company entered into a termination agreement for its U.S.

January 2022, the company entered into a termination agreement for its U.S.

office in Summit, NJ, following the resizing of its facility use.

The Company recognized an income of $ 1.2 million as of June 30, 2022 due to the early termination of its Summit, NJ lease, offset by the payment of a one-time

lump sum early termination fee of $ 1.5 million.

On March 28, 2022, the Company entered into a binding office lease agreement in New Jersey for a lease term of 3 years and 2 months .

The Company recognized an income of $ 1.2 million as of June 30, 2022 due to the early termination of its Summit, NJ lease, offset by the payment of a one-time lump sum early termination fee of $ 1.5 million.

On March 28, 2022

, the Company entered into a binding office lease agreement in New Jersey for a lease term of

3 years and 2 months .

The lease commencement was based upon delivery of possession of the premises by the Landlord and occurred on April 1, 2022.

Right of use and related lease debt have been recorded starting April 1, 2022 for a gross amount of $ 0.4 million.

Supplemental cash flow information related to operating leases is as follows for the period December 31, 2022 and 2021:

Right of use and related lease debt have been recorded starting April 1, 2022 for a gross amount of $

In November, 2023, the Company signed agreements for the new headquarters in Chatillon, 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 millions

cash flow information related to operating leases is as follows for the year ended December 31, 2023 and 2022:

Cash paid for amounts included in the measurement of lease liabilities

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Note 7 Other non-current

Other non-current

assets consisted of the following:

Other non-current assets consisted of the following:

FX facility collateral account

Deposits, pledged securities and other non-current

financial assets

Deposits, pledged securities and other non-current financial assets

Liquidity contract

Total other non-current

The other non-current

assets are composed of security deposits paid to premises lessors, pledged securities, the liquidity contract and a collateral account to guarantee a FX facility not used as of December 31, 2022.

Total other non-current assets

The other non-current assets are composed of security deposits paid to premises lessors, pledged securities, the liquidity contract and a collateral account to guarantee a FX facility not used as of December 31, 2023.

Under the liquidity contract, 222,988 treasury shares were allocated as a reduction of Shareholders’ Equity as at December 31, 2023 with the cash balance being maintained in financial assets.

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The other current liabilities include short-term debt related to employees’ bonus accruals, as well as social welfare and tax agencies.

Deferred income mainly includes deferred income from the collaboration agreement with Nestlé Health Science, which amounted to $ 2.1 million as of December 31, 2022.

Note 9 Financial debt and Other Non-Current

Financial debt—Conditional Advances

The table below presents the details of the debts recorded on the statement of financial position by the type of conditional advance:

Balance sheet debt at start of period 01/01/2021

Other movements

Balance sheet debt as at 12/31/2021

Of which—Non-current

Of which—Current portion

Stated interest rate

Discount rate

Maturity (in years)

Balance sheet debt at start of period 01/01/2022

Other movements

Balance sheet debt as at 12/31/2022

Stated interest rate

Discount rate

Maturity (in years)

The changes appearing in “Other movements” are comprised of the effect of discounting conditional advances.

BpiFrance Financement Interest Free Loan

The Company has been granted until September 2022 a € 3.0 million interest-free Innovation loan from BpiFrance Financement to help financing the pharmaceutical development of Viaskin ™

This amount was received in a single disbursement on November 27, 2014.

On October 30, 2023, the Company signed a

Termination letter agreement with

As of December 31

2023, we recorded

a deferred revenue accrual reversal of $ 6.9 millions (including $

2.1 millions in current liabilities and $

4,7 millions in non current liabilities).

Note 9 Other Current and Non-Current

Due dates of liabilities

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

Other liabilities

Other current liabilities

Supplier accounts payable and related payables

Total liabilities

As detailed in Note 8, the current portion of other liabilities mainly includes social security and deferred incomes from the collaboration agreement with Nestlé Health Science.

The current portion of other liabilities mainly includes social security .

Other non-current

Effective October 30, 2023 ,the Company and Nestlé Health Science signed an agreement, terminating the collaboration agreement between the two parties and the PII clinical study.

Consequently as of December 31, 2023, we recorded the following:

Deferred revenue accrual reversal $ 6.9 millions (including $ 4.7 millions recorded in Other non-current

liabilities as of December 31, 2022).

Note 10 Fair value measurement

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The share capital, as of December 31, 2023, is set at the sum of € 9,643,177 ($ 10,972,101 converted at historical rates).

It is divided into 94,137,145 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.

It is divided into 96,431,770 fully authorized, subscribed and paid-up shares with a nominal value of € 0.10 .

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, 2022 (the “Board General Meeting”):

decided, within the framework of the PIPE financing 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

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

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:

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

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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.

capital increase of a nominal amount of € 3,285,566.90 together with a share premium of € 95,281,440.10 , 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 euro (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;

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 18th resolution of the Board General Meeting beneficiaries under the conditions defined in section 5 of the offering circular relating to the PIPE financing.

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

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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

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.

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.

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:

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Share capital*

Additional paid-in

Number of shares

Balance as of December 31, 2021