What changed in this filing

/stocks — the workspaceLOADING

Item 9A. Controls and Procedures

2023-03-02 compared with 2022-03-09 · 316 added, 333 removed, 931 unchanged (41% of the section changed)

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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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Executive Compensation.

The information required by this Item 11 will be included in the sections titled “Executive Compensation” and “Board of Directors and Corporate Governance” in our Proxy Statement and is incorporated herein by reference.

The information required by this Item 11 will be included in the sections titled “Executive Compensation” (excluding the information under the subheading “Pay Versus Performance”) and “Board of Directors and Corporate Governance” in our Proxy Statement and is incorporated herein by reference.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

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and Baker Brothers Life Sciences, L.P.

Registration Rights Agreement, dated as of June 8, 2022, between the registrant and the Investors named therein.

Securities Purchase Agreement, dated as of June 8, 2022, between the registrant and the Subscribers named therein.

Office Lease between the registrant and GENERALI VIE, dated March 3, 2015 (English translation)

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2015 Free Share Plans (English translation)

Incorporated by Reference

2016 Share Option Plan (English translation)

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2017 Free Share Plan (English translation)

Incorporated by Reference

2018 Share Option Plan (English translation)

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2021 Free Share Plan (English translation)

2022 Stock Option Plan (English translation)

2022 Free Share Plan (English translation)

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

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List of subsidiaries of the registrant

Consent of Deloitte & Associés and KPMG S.A.

Consent of Deloitte & Associés

Consent of KPMG S.A.

Power of Attorney (included on the signature page of this report).

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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Inline XBRL Taxonomy Extension Schema Document

Incorporated by Reference

Inline XBRL Taxonomy Extension Calculation Linkbase Document

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/s/ Michael J.

/s/ Viviane Monges

Viviane Monges

/s/ Danièle Guyot-Caparros

Danièle Guyot-Caparros

/s/ Timothy E.

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Notes to the Consolidated Financial Statements

REPORT OF INDPENDENT REGISTERED PUBLIC ACCOUNTING FIRMS

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMS

To the Shareholders and Board of Directors of DBV Technologies S.A.

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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, 2021 and 2020, 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, 2021, 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, 2021 and 2020, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2021, 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 projected to be 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.

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.

Basis for Opinion

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

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 and that:

(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 a critical audit matter 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 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 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 is not sufficient to support its operating plan for at least the next 12 months from the issuance date of these consolidated financial statements.

As such, there is substantial doubt 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.

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 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.

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 obtained an understanding and tested the design and implementation of the internal control related to the Company’s going concern assessment;

We evaluated the reasonableness of the Company’s forecasted operating expenses by obtaining an understanding of the Company’s operations and strategy, inquiring about the Company’s research and development activities, comparing the forecasted operating expenses to historical operating expenses and assessing expected costs, especially those costs that relate to future clinical trials;

We assessed management’s ability to forecast operating expenses 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.

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.

/s/ Deloitte & Associés

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Défense, France

March 2, 2023

DBV Technologies S.A.

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Ordinary shares, € 0.10 par value;

55,095,762 and 54,929,187 shares authorized, and issued as at December 31, 2021 and 2020, respectively, and 5,128,423 and 4,036,263 shares outstanding as at at December 31, 2021 and 2020, respectively

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

Additional paid-in

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financial assets

Proceeds from non-current

financial assets dispositions

Net cash flows used in investing activities

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Balance at January 1, 2021

Other comprehensive income (loss)

Other comprehensive (loss)

Issuance of ordinary shares

Issuance of share warrants

Treasury shares

Share-based payments (income) expenses

Allocation of accumulated net losses

Balance at December 31, 2021

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Allocation of accumulated net losses

Other change in equity

Balance at December 31, 2022

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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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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.

The Company is currently engaged in fruitful discussions with FDA in preparation for protocol submission and review.

The Company expects to complete protocol submission following further alignment with FDA.

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 its current operations, as well as its plans and assumptions as revised pursuant to its change of strategy, announced in December 2021, the Company expects that its balance of cash and cash equivalents of

$ 77.3 million as of December 31, 2021 will be sufficient to fund its operations into the first quarter of 2023.

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.

In June 2022, the Company announced that its pivotal Phase 3 trial EPITOPE, assessing the safety and efficacy of Viaskin Peanut treatment of peanut-allergic toddlers ages 1 to 3 years, met its primary endpoint, with a statistically significant treatment effect.

The Company also indicated continuing productive dialogue with the FDA on the protocol design of VITESSE, a pivotal Phase 3 trial of the modified Viaskin Peanut patch in peanut-allergic children ages 4 to 7 years.

During the same month, the Company announced private placement financing (“PIPE”) amounting to $ 194 million.

In September 2022, after announcing initiating, the Company received a partial clinical hold letter from the FDA on its VITESSE Phase 3 clinical study.

Within the FDA’s communication, the modifications address design elements, including the statistical analysis of adhesion, minimum daily wear time and technical alignments in methods of categorizing data, to meet study objectives as well as the total number of trial participants on active treatment.

In December 2022, the Company received confirmation from the FDA that it lifted the partial clinical hold on its VITESSE Phase 3 clinical study.

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

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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 has already caused extreme volatility and disruptions in the capital and credit markets.

pandemic and conflict in Ukraine have already 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.

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

Property, plant, and equipment are depreciated on a straight-line method over the estimated useful lifes of the property.

Property, plant, and equipment are depreciated on a straight-line method over the estimated useful lives of the property.

Leasehold improvements are amortized over the shorter of the estimated useful lives of the assets or the remaining lease term.

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PROPERTY, PLANT, AND EQUIPMENT ITEM PERIOD

Fixtures and leasehold improvements

Research and development / production tools

Research equipment and technical facilities

Computer equipment

Laboratory equipment and technical facilities

3 to 10 years

Building fixtures and leasehold improvements

Office equipment and furniture

Computer equipment

Impairment of assets

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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

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.

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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.

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The expenditures taken into account for the calculation of the research tax credit involve only research expenses.

In the fiscal year ended December 31, 2021, the Company recovered its Small and Medium-sized

In the fiscal year ended December 31, 2021, the Company recovered its Small and

Enterprises, or SMEs, status under EU law, and became therefore eligible again for the immediate reimbursement of the Research Tax Credit.

The Company will request the immediate reimbursement of the 2021 fiscal year CIR, as well as former tax credit receivables for the 2019 and 2020 fiscal years, which were originally refundable three years after the tax declaration in case the Company wouldn’t have been able to offset it against corporate income tax due.

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.

Collaboration agreement with Nestlé Health Science

The Company enters into research and development collaboration agreements that may consist of non-refundable

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

upfront payments and milestone payments.

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The Company recognizes 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.

Please refer to Note 1 4

“Contingencies”.

Please refer to Note 13 “Contingencies”.

Research and Development Expenditures

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Other Items in the Comprehensive Loss

Comprehensive loss

is comprised of net income(loss) and other comprehensive income (loss).

Comprehensive loss is comprised of net income(loss) and other comprehensive income (loss).

Other comprehensive income (loss) includes changes in equity that are excluded from net income (loss), such as foreign currency translation adjustments.

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The Consolidated Statements of Financial Position and the Consolidated Statements of Operations and Comprehensive Loss of the Company are adjusted to reflect the subsequent events that alter the amounts related to the situations that existed as of the end of the period covered.

The Company has evaluated subsequent events from the balance sheet date through March

, 2022, the date at which the consolidated financial statements are issued.

The Company has evaluated subsequent events from the balance sheet date through March 2, 2023, the date at which the consolidated financial statements are issued.

Accounting Pronouncements adopted in 2022

Effective January 1, 2021, the Company adopted ASU 2019-12,

Income Taxes (Topic 740)—Simplifying the Accounting for Income Taxes, which is intended to simplify accounting for income taxes.

It removes certain exceptions to the general principles in Topic 740 and amends existing guidance to improve consistent application.

The adoption of ASU 2019-12

did not have a material impact on the Company’s financial position or results of operations.

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

Accounting Pronouncements issued not yet adopted

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United States Regulatory History and Current Status

Viaskin Peanut has obtained fast track designation and breakthrough therapy designation in children from the FDA, which are regulatory designations intended to expedite or facilitate the process of reviewing new drugs and biological products that are intended to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition.

In August 2019, the Company announced the submission of a BLA to the FDA for Viaskin Peanut for the treatment of peanut allergy in children 4 to 11 years of age.

In October 2019, the Company announced that the FDA accepted for review the BLA for its investigational Viaskin ™

Peanut immunotherapy for the treatment of peanut-allergic children ages 4 to 11 years.

In February 2020, the FDA announced an Allergenic Products Advisory Committee meeting to be held on May 15, 2020 to discuss the BLA for Viaskin Peanut.

On March 16, 2020, the Company announced that the FDA had informed it that during its ongoing review of the Company’s BLA for Viaskin Peanut, it had identified questions regarding efficacy, including the impact of patch-site adhesion.

Therefore, the Advisory Committee meeting to discuss the BLA originally scheduled on May 15, 2020 was cancelled.

In August 2020, the Company received a Complete Response Letter, or CRL, in which the FDA indicated it could not approve the Viaskin Peanut BLA in its current form.

The FDA identified concerns regarding the impact of patch-site adhesion on efficacy and indicated the need for patch modifications, and subsequently a new human factor study.

The FDA also indicated that supplementary clinical data would need to be generated to support the modified patch.

In addition, the FDA requested additional Chemistry, Manufacturing and Controls, or CMC, data.

The FDA did not raise any safety concerns related to Viaskin Peanut.

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.

g (approximately 1/1000 of

one peanut) remains unchanged and performs in the same way it has performed previously.

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

The FDA agreed with its position that a modified Viaskin Peanut patch should not be considered as a new product entity provided the occlusion chamber of the current Viaskin Peanut patch and the peanut protein dose of 250 µg (approximately 1/1,000 of one peanut) remains unchanged and performs in the same way it has performed previously.

In order to confirm the consistency of efficacy data between the existing and a modified patch, FDA requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4 - 11 .

The Company named that assessment EQUAL, which stands for Equivalence in Uptake of Alergen.

The Company named that assessment EQUAL, which stands for Equivalence in Uptake of Allergen.

The FDA also recommended conducting a 6 -month,

well-controlled safety and adhesion trial to assess a modified Viaskin Peanut patch in the intended patient population.

The Company later named this study STAMP, which stands for Safety, Tolerability, and Adhesion of Modified Patches.

The Company later named this clinical trial STAMP, which stands for Safety, Tolerability, and Adhesion of Modified Patches.

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

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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 study as soon as possible.

The Company prioritized the STAMP protocol submission so the Company could begin the clinical trial as soon as possible.

Demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population via EQUAL.

The complexity of EQUAL hinged on the lack of established clinical and regulatory criteria to characterize allergen uptake via an epicutaneous patch.

To support those exchanges, the Company outlined its proposed approach to demonstrate allergen uptake equivalence between the two patches, and allotted time to generate informative data through two additional studies:

PREQUAL, a Phase I study with adult healthy volunteers to optimize the allergen sample collection methodologies and validate the assays we intend to use in EQUAL

‘EQUAL in adults’—a second Phase I study 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 trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches, to identify the one or two best-performing patches, which the Company completed in the second quarter of 2021.

Based on the adhesion parameters studied, the Company selected the modified patch to advance to further clinical testing in the intended patient population.

All modified Viaskin Peanut patches demonstrated better adhesion performance as compared to the then-current Viaskin Peanut patch, and the Company then selected two modified patches that performed best out of the five modified patches studied for further development.

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.

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 .

The Company completed CHAMP in the second quarter of 2021.

All modified Viaskin Peanut patches demonstrated better adhesion performance as compared to the then-current Viaskin Peanut patch, and based on the results of CHAMP, the Company then selected two modified patches that performed best out of the five modified patches studied for further development.

The Company then selected the circular patch for further development, which is approximately 50% larger in size relative to the current patch and circular in shape.

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In this letter, the FDA requested a stepwise approach to the modified Viaskin patch development program and provided partial feedback on the STAMP protocol.

Specifically, the FDA requested that the Company conducts allergen uptake comparison

studies (i.e., ‘EQUAL in Adults’, EQUAL), and submits the allergen uptake comparison data for FDA review and feedback prior to starting the STAMP study.

Specifically, the FDA requested that the Company conducts allergen uptake comparison trials (i.e., ‘EQUAL in Adults’, EQUAL), and submits the allergen uptake comparison data for FDA review and feedback prior to starting the STAMP study.

The FDA’s explanation was that the results from the allergen uptake studies might affect the design of the STAMP study.

After careful review of the FDA’s information requests and consideration of all other options, 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.

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

The Company estimated that the FDA’s newly proposed sequential approach would require at least five rounds of exchanges that necessitate FDA alignment prior to initiating STAMP, the 6-month

safety and adhesion study.

The Company does not believe this approach to be in the best interest of patients due to the significant time delays associated with FDA review of a resource dependent (non-PDUFA)

As such, in December 2021, the Company announced it plans to initiate a pivotal Phase III—placebo-controlled efficacy trial for a modified Viaskin Peanut patch (mVP) in children in the intended patient population.

The study will also include updates to the Instructions for Use (IFU).

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

The FDA has confirmed its change in strategy is agreeable via oral and written exchanges.

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.

The Company is currently engaged in discussions with FDA in preparation for protocol submission and review.

The Company expects to complete protocol submission following further alignment with FDA.

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

years old) and more sensitive children with peanut allergy.

European Union Regulatory History and Current Status

In November 2020, the Company announced that its Marketing Authorization Application, or MAA, for Viaskin Peanut 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 Viaskin Peanut to treat peanut allergies in children ages 4 to 11 years.

Following the MAA validation, the EMA’s Committee for Medicinal Products for Human Use, or CHMP, will review the application and provide a recommendation to the European Commission, or EC, on whether to grant a marketing authorization.

On March 11, 2021, the Company announced that it had received the EMA’s Day 120 questions, which were consistent with both its expectations and pre-

filing conversations with the EMA.

The Company did not receive questions about the impact of adhesion on efficacy.

In August 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 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.

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.

In December 2021, the Company announced it has withdrawn the Marketing Authorization Application for Viaskin Peanut and formally notified the EMA of our decision.

The initial filing was supported by positive 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 study 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 study will support a more robust path for licensure of Viaskin Peanut in the EU.

On December 20, 2021, the Company announced it has withdrawn 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 Company believe data from a second Viaskin Peanut pivotal clinical trial will support a more robust path for licensure of Viaskin Peanut in the EU.

The Company intend to resubmit the MAA when that data set is available.

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In June 2020, the Company announced that in Part A, patients in both treatment arms showed consistent treatment effect after 12 months of therapy, as assessed by a double-blind placebo- controlled food challenge and biomarker results.

Part A subjects were not included in Part B and the efficacy analyses from Part A were not

statistically powered to demonstrate superiority of either dose versus placebo.

These results validate the ongoing investigation of the 250 m

g dose in this age group, which is the dose being studied in Part B of the study.

Enrollment of Part B of EPITOPE was complete in first quarter of 2021, and top-line results are expected mid-year 2022.

In February 2020, the Company announced the closing of an underwritten global offering of an aggregate of 7,500,000 ordinary shares in (i) a public offering of 4,535,581 ordinary shares in the form of 9,071,162 American Depositary Shares (“ADSs”) in the United States, Canada and certain countries outside Europe at a public offering price of $ 10.25 per ADS (on the basis of an exchange rate of $ 1.0999 = €1.00), and (ii) an offering exclusively addressed to qualified investors in Europe (including France) of 2,964,419 ordinary shares at an offering price of € 18.63 per ordinary share (together, the “Global Offering”).

In March 2020, the Company announced that the underwriters partially exercised their option to purchase 338,687 additional ordinary shares in the form of 677,374 ADSs at an offering price of $ 10.25 per ADS, before deducting commissions and estimated offering expenses (the “Option”).

The Option closed on March 4, 2020.

Consequently, following partial exercise of the Option, the total number of ordinary shares sold in the global offering was 7,838,687 ordinary shares, including 4,874,268 ordinary shares in the form of 9,748,536 ADSs, bringing the total gross proceeds from the global offering to $ 160.7 million and net proceeds of $ 150.0 million.

Restructuring

The Company initiated a global restructuring plan in June 2020 to provide operational latitude to progress in the clinical development and regulatory review of investigational Viaskin ™

Peanut in the United States and European Union.

Full implementation of the organization-wide costs reduction measures was completed during the second half of 2021.

The full implementation of the restructuring plan resulted in a reduction of more than 200 jobs and in a remaining global team of about 90 people dedicated to the pursuit of innovation and scientific development of novel therapies.

The restructuring costs were mainly comprised of payroll expenses, restructuring-related consulting and legal fees, as well as impairment of facilities and right of use assets following resizing of facilities.

The following table summarizes restructuring effects as of December 31, 2021 and 2020 included in the Statement of Operations and Comprehensive Loss:

Employee-related expenses (income)

Effects of restructuring on leases

Other restructuring costs

Total restructuring costs

The following table summarizes restructuring activities as of December 31, 2021 included in current contingencies and other current liabilities on the statement of consolidated financial position:

(Amounts in thousands of U.S.

Restructuring

Restructuring liability —

January 1, 2020

Restructuring costs

Restructuring costs —

non cash items

Restructuring liability —

December 31, 2020

of which current contingencies

of which other current liabilities

Restructuring

Restructuring liability —

January 1, 2021

Restructuring costs

Reversal of contingencies

Other effect including currency translation effect

Restructuring liability —

December 31, 2021

of which current contingencies

of which other current liabilities

The reversal of contingencies is mainly comprised of unused accruals related to payroll.

Part A subjects were not included in Part B and the efficacy analyses from Part A were not statistically powered to demonstrate superiority of either dose versus placebo.

These results validate the ongoing investigation of the 250 µg dose in this age group, which is the dose being studied in Part B of the study.

Enrollment of Part B of EPITOPE was complete in first quarter of 2021.

In June 2022, we announced positive topline results from Part B of EPITOPE, which enrolled 362 subjects ages 1 to 3 years, of which 244 and 118 were in the active and placebo arms, respectively.

Enrollment was balanced for age and baseline disease characteristics between the active and placebo treatment arms.

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

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

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.

On September 21, 2022, we announced we had received feedback from the FDA in the form of a partial clinical hold on VITESSE.

In the partial clinical hold letter, the FDA specified changes to elements of the VITESSE protocol, acknowledging the intent for the trial to support a future BLA submission.

In the following months, we engaged with the FDA to address the feedback provided in the partial clinical hold letter and to finalize the VITESSE protocol.

In addition, we continued internal preparations for VITESSE and conducted certain site assessment and start-up

activities for prompt study launch once the partial clinical hold was lifted.

On December 23, 2022, we announced the FDA lifted the partial clinical hold and confirmed we satisfactorily addressed all clinical hold issues.

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

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

This global health crisis led many countries to impose national containment measures and travel bans.

In view of this exceptional situation, the Company decided to take all measures aimed primarily at guaranteeing the safety of its employees and the continuation of ongoing clinical trials, in compliance with the directives of the authorities in each country.

The Company has experienced a decrease in new patients enrolling in the ongoing clinical studies and it has had to adapt the protocols of its clinical trials because patients remain subject to travel restrictions.

The Company has assessed the impact of the uncertainties created by the pandemic, such as the duration of the outbreak, the efficacy of vaccines and the evolution of variations strains of COVID-19,

travel restrictions, social distancing requirements and business restrictions in the United States, France and other countries.

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 COVID-19

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.

Legal Proceedings

From time to time, we may become subject to various legal proceedings and claims that arise in the ordinary course of our business activities.

We are not currently subject to any material legal proceedings.

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

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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.

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

The Company believes that the allegations contained in the amended complaint are without merit and will continue to defend the case vigorously.

The Company believes this complaint will not have a material adverse effect on the Company’s consolidated financial position, results of operations or liquidity.

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

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

Cash equivalent s

Total cash and cash equivalent s

as reported in statement of financial position

Bank overdrafts

2 unchanged sentences

They are measured using level 1 fair value measurements.

Note 4 Trade Receivables

All the trade receivables have payment terms of less than one year.

As of December 31, 2020, the receivables balance corresponds exclusively to the amounts due under the license and collaboration agreement with Nestlé Health Science, which have been settled during the year 2021.

Note 4 Other Current Assets

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Other receivables

The other tax claims are primarily related to deductible VAT.

Prepaid expenses are comprised primarily of insurance expenses, as well as legal and scientific consulting fees.

Prepaid expenses also include upfront payments which are recognized over the term of the ongoing clinical studies.

Research tax credit

1 unchanged sentence

Enterprises, or SMEs, status under EU law, and became therefore eligible again for the immediate reimbursement of the Research Tax Credit.

The Company will request the immediate reimbursement of the 2021 fiscal year CIR, as well as former tax credit receivables, which were originally refundable three years after the tax declaration in case the Company wouldn’t have been able to offset it against corporate income tax due.

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

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

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

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- Payment received

- Currency translation effect

- Adjustment and currency translation effect

Closing balance sheet receivable as of December 31, 2021

Current portion

Of which—Non-current

Of which—Current portion

Opening balance sheet receivable as of January 1, 2022

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Closing balance sheet receivable as of December 31, 2022

Of which —Non

Of which —Current

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 rental and insurance expenses, as well as legal and scientific consulting fees.

Prepaid expenses also include upfront payments which are recognized over the term of the ongoing clinical studies.

Of which—Non-current

Of which—Current portion

Note 5 Property, Plant, and Equipment

6 unchanged sentences

Less accumulated amortization and depreciation

Relassification

Laboratory equipment

4 unchanged sentences

Less accumulated amortization and depreciation

The depreciation and amortization expense for each of

the years ended December 31, 2021 and 2020 was $ 4.4 million .

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

The depreciation and amortization expense for each of the years ended December 31, 2022 and 2021 was $ 2.7 million and $ 4.4 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

Restructuring expense

Supplemental cash flow information related to operating leases is as

follows for the period December 31, 2021 and 2020:

Net termination impact

In 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 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:

Cash paid for amounts included in the measurement of lease liabilities

3 unchanged sentences

assets consisted of the following:

Research tax credit

Pledged securities

Deposits and other non-current

FX facility collateral account

Deposits, pledged securities and other non-current

financial assets

1 unchanged sentence

Total other non-current

The non-current

assets are composed of security deposits paid to premises lessors, pledged securities not used as of December 31, 2021 and the liquidity contract.

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.

Under the liquidity contract, 149,793 treasury shares were allocated as a reduction of Shareholders’ Equity as at December 31, 2022 with the cash balance being maintained in financial assets.

7 unchanged sentences

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

As of December 31, 2020, the other current liabilities also included employee termination allowance and benefits as part of the restructuring (Refer to Note 2, “Significant Events and Transactions of the Periods—Restructuring”),

Deferred income mainly includes deferred incomes from the collaboration agreement with Nestlé Health Science, which amounted to $ 4.1 million as of December 31, 2021.

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

2 unchanged sentences

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

Other including currency translation effect

Other movements

Balance sheet debt as at 12/31/2021

Current portion

Of which—Non-current

Of which—Current portion

Stated interest rate

2 unchanged sentences

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

Other including currency translation effect

Other movements

Balance sheet debt as at 12/31/2022

Current portion

Stated interest rate

1 unchanged sentence

Maturity (in years)

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

The portion of the conditional advances for terms longer than one year is classified as non-current

liabilities, while the portion for terms of less than one year is classified as current liabilities.

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

BpiFrance Financement Interest Free Loan

In 2014, BpiFrance Financement granted an interest-free Innovation loan to DBV Technologies to help financing the pharmaceutical development of Viaskin ™

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.

The initial planned repayment was scheduled in 20 quarterly repayments, starting on June 30, 2017.

In 2020, due to the COVID-19

pandemic, Bpifrance postponed the repayments for a 6 -month

Repayment will end during the third quarter of 2022.

Due dates of liabilities

The following table shows the maturity of the Company’s liabilities (except leases disclosed in Note 7—“Lease contract”):

Short-term financial debt —

Conditional advances

Other liabilities

11 unchanged sentences

For the interest-free conditional advances, the discount rate applied is equal to the rate of fungible treasury bonds over the time period that corresponds to the time period of the repayment of the advances.

As of December 31, 2021, the fair value of conditional advances was $ 0.5 million.

There has been no transfer between levels of the fair value hierarchy during the years ended December 31, 2021 and 2022.

4 unchanged sentences

This number does not reflect ordinary shares issuable upon exercise or settlement of non-employee

warrants (“BSA”), employee warrants (“BCE”), stock options (“SO”) and restricted stock units (“RSU”) granted to both employees and non-employees

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

resolution of the Board General Meeting;

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

sub-delegated

its authority to the Chief Executive Officer for the purpose of implementing the financing.

The Chief Executive Officer, acting pursuant to the sub-delegations

of authority granted by the Board of Directors of the Company on June 8, 2022, after receiving the favorable opinion of the Pricing Committee established by the Board of Directors, has, on June 9, 2022:

decided, making use of the 18 th

resolution of the Board General Meeting, to proceed with a capital increase in cash with cancellation of preferential subscription rights reserved for categories of investors, in accordance with the Article L.

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 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;

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.

The Company has assessed the pre-funded

warrants for appropriate equity or liability classification.

During this assessment, the Company determined the pre-funded

warrants are freestanding instruments that do not meet the definition of a liability pursuant to ASC 480 and do not meet the definition of a derivative pursuant to ASC 815.

The 2022 Warrants are classified as a component of permanent equity because they are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock with which they were issued, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permit the holders to receive a fixed number of shares of common stock upon exercise.

In addition, the 2022 Warrants do not provide any guarantee of value or return.

Accordingly, the pre-funded

warrants are classified as equity and accounted for as a component of additional paid-in

capital at the time of issuance.

The changes in number of outstanding prefunded warrants are as follows:

Balance as of December 31, 2021

Granted during the period

Forfeited during the period

Exercised/released during the period

Expired during the period

Balance as of December 31, 2022

The table below presents the changes in the share capital of the Company as of December 31, 2021 and 2022:

5 unchanged sentences

Number of shares

Balance as of January 1, 2020

Capital increase by employee warrants

Capital increase by stock options

Capital increase by global offering

Fees charged to share premium

Capital increase by global offering

Fees charged to share premium

Capital increase by RSU

Share-based payments

Balance as of December 31, 2020

13 unchanged sentences

Balance as of December 31, 2021

Capital increase by ordinary shares

Capital increase by ATM program

Retained earnings charged on share premium

Capital increase by employee warrants

Capital increase by ordinary shares

Capital increase by share warrants

Capital increase by employee warrants

Capital increase by ordinary shares

Share-based payments

Balance as of December 31, 2022

Conversion in U.S.

2 unchanged sentences

after appropriation of the net result for the year ended December 31, 2021 have been allocated to additional paid-in

capital in the amount of € 695,575,130 ($ 797,822,881 converted at historical rates).

capital in the amount o

converted at historical rates).

Note 12 Share-Based Payments

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Number granted

In the following tables in Notes 13.1 to 13.4, exercise prices, grant date share fair values and fair value per equity instruments are provided in euros, as the Company is incorporated in France and the euro is the currency used for the

employee warrants

In the following tables related to share-based payments, exercise prices, grant date share fair values and fair value per equity instruments are provided i n

euros, as the Company is incorporated in France and the euro is the currency used for the grants.

12.1 Non-employee

The Company’s board of directors has been authorized by the shareholders’ general meeting to grant BSAs to non-employee’s

members of the Board of Directors and members of the Scientific Advisory Board.

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

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

During the year ended December 31, 2021, pursuant to the authorization granted by the General Meeting of the Shareholders held on May 19, 2021, the Company offered the directors the opportunity to subscribe for warrants to purchase ordinary shares on May 19, 2021, and on June 3, 2021, the directors subscribed for warrants to purchase an aggregate of 39,185 ordinary shares.

4 unchanged sentences

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

Weighted average share price at grant date (

Weighted average share price at grant date (in €)

Weighted average expected volatility

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Dividend yield

Weighted average fair value of warrants (

Weighted average fair value of warrants (in €)

The following table summarizes all BSA activity during the year ended December 31, 2021:

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12.2 Employee warrants

The Company’s Board of Directors has been authorized by the shareholders’ general meeting to grant BSPCE warrants (Bons de Souscription de Parts de Créateur d’Entreprise or “BSPCE”) to employees.

The Company no longer grants BCE warrants since 2011.

The following table summarizes all BSPCE warrants activity during the year ended December 31, 2020:

exercise price

term (in years)

intrinsic value

Balance as of December 31, 2019

Granted during the period

Forfeited during the period

Exercised during the period

Expired during the period

Balance as of December 31, 2020

Warrants exercisable as of December 31, 2020

The following table summarizes all BSPCE warrants activity during the year ended December 31, 2021:

exercise price

term (in years)

intrinsic value

Balance as of December 31, 2020

Granted during the period

Forfeited during the period

Exercised during the period

Expired during the period

Balance as of December 31, 2021

Warrants exercisable as of December 31, 2021

There were no

warrants grants during the years ended December 31

As of December 31, 2022, no more BSPCE / BCE warrants (Bons de Souscription de Parts de Créateur d’Entreprise or “BSPCE”) are exercisable.

12.3 Stock options

15 unchanged sentences

The following table summarizes all stock options activity during the year ended December 31, 2021:

Weighted-average

exercise price in

Weighted-average

contractual term

8 unchanged sentences

The following table summarizes all stock options activity during the year ended December 31, 2022:

Weighted-average

exercise price in

Weighted-average

contractual term

7 unchanged sentences

Options exercisable as of December 31, 2022

Stock options have been granted during the years ended December 31, 2021 and 2020.

The weighted-average exercise price of SO granted during the year ended December 31, 2021 was € 6.09 per share.

As of December 31, 2022, there was € 9.3 million ($ 9.9 million converted at closing rate) of unrecognized SO expense that is expected to be recognized over a weighted-average period of 3.4 years.

24 unchanged sentences

12.4 Restricted stock units

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

RSUs to employees.

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

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

22 unchanged sentences

Balance as of December 31, 2021

The service conditions have been met in 2020 for the plan granted on May 10, 2019 with a total fair value of € 1.3 million.

The following table summarizes all RSUs activity for the year ended December 31, 2021:

The following table summarizes all RSUs activity for t h

e year ended December 31, 2022:

average grant

5 unchanged sentences

Balance as of December 31, 2022

The plan granted on May 10, 2019 vested in 2020 with a total fair value of € 1,288 thousands.

This plan is not included in the previous table since the RSUs will be released, and shares issued once the performance condition will be achieved (approval of Viaskin ™

Peanut by the U.S.

As of December 31, 2022, there was € 2.6 million ($ 2.8 million converted at closing rate) of unrecognized RSUs compensation expense that is expected to be recognized over a weighted-average period of 3.4 years.

4 unchanged sentences

Total share-based compensation (expense) income

As of December 31, 2020, reversal of share-based payments expenses was mainly due to the restructuring plan announced on June 26, 2020 which led to significant reduction in the Company’s workforce.

Note 13 Contingencies

3 unchanged sentences

Total contingencies

The table below shows movements

in contingencies:

Pension retirement

The table below shows movements in contingencies:

Collaboration

agreement—Loss at

Other contingencies

agreement—Loss

at completion

contingencies

At January 1, 2021

8 unchanged sentences

Of which Non-current

Collaboration

agreement—Loss

at completion

contingencies

At January 1, 2022

8 unchanged sentences

Of which Non-current

The Company does not hold any plan assets for any

periods presented.

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

As of December 31, 2022, the Company updated its measurement of progress of the Phase 2 clinical trial (“PII”) conducted as part of the collaboration and license agreement with Nestlé and updated the cumulative income recognized.

The Company has recorded an accrual in the amount of the excess between the Company’s current best estimates of costs yet to be incurred and incomes yet to be recognized for the completion of the PII.

As of December 31, 2020, other contingencies were mainly composed of the estimated to be incurred as part of the social costs related to restructuring, as well as estimated cost of refurbishment on lease premises (Refer to Note 2, “Significant Events and Transactions of the Periods—Restructuring contingencies”).

The Company has recorded an accrual in the amount of the excess between the Company’s current best e stimates

of costs yet to be incurred and income yet to be recognized for the completion of the PII.

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

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Collective agreement

National Collective Agreement of the pharmaceutical industry

National Collective Agreement of

the pharmaceutical industry

Note 14 Operating Income

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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, and if appropriate regulatory approvals are received, Nestlé Health Science will support the commercialization of MAG1C globally, while prioritizing certain agreed-upon countries.

Under the terms of the exclusive collaboration, the Company is responsible for leading the development activities of MAG1C up through a pivotal Phase 3

clinical program, and if appropriate regulatory approvals are received, Nestlé Health Science will support the commercialization of

MAG1C globally, while prioritizing certain agreed-upon countries.

The Company entered into an amendment with Nestlé Health Science on July 12, 2018.

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upfront payment of € 10.0 million that the Company received in July 2016.

In 2020 and 2021, the ongoing COVID-19

pandemic impacted the Company’s current clinical trials, including the Phase II clinical trial conducted as part of the development activities pursuant to the collaboration and license agreement with Nestlé Health Science.

The Company experienced difficulties in enrolling new patients in this Phase II clinical trial and modified the protocols of the clinical trial.

As a result of the accumulation of recruitment delays, the Company expects to incur additional clinical and production costs related to the Phase II clinical trial.

As of December 31, 2021, the Company recorded its collaboration agreement’s revenue based on its updated measurement of progress of the Phase II clinical trial conducted as part of the agreement.

The accrual recorded in the amount of the difference between the Company’s current best estimates of costs yet to be incurred and revenues yet to be recognized for the completion of the Phase II clinical trial has been updated accordingly.

The Company’s current clinical trials, including the Phase 2 clinical trial conducted as part of the development activities pursuant to the Development, Collaboration and License agreement with Nestlé Health Science, have been impacted by the Covid-19

pandemic, among other factors.

The Company has experienced difficulties in enrolling new patients in this Phase 2 clinical trial notwithstanding the implementation of a protocol amendment and various other strategies to improve recruitment.

As a result of the accumulation of recruitment delays, the Company expects to incur additional clinical and production costs related to the Phase 2 clinical trial as well as delays in achievement of upcoming milestones.

As of December 31, 2022, the Company recorded its collaboration agreement’s revenue based on its updated measurement of progress of the Phase 2 clinical trial conducted as part of the agreement.

Note 15 Allocation of Personnel Expenses

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Total personnel expenses

Restructuring personnel expenses excluding effect of accrual for the year ended December 31, 2020 and reversal for the year ended December 31, 2021.

Restructuring personnel expenses excluding reversal for the year ended December 31, 2021.

Allocation of Personnel Expenses by Nature:

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Expenses for pension commitments

Employer contribution to bonus shares

Share-based payments

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(Loss) before taxes

Theoritical company tax rate

Theoretical company tax rate

Nominal tax expense

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Peanuts and Viaskin ™

Milk products, the Company.

As of December 31, 2021, we had non-cancellable

contractual obligations with CRO until year ended 2024 for $ 30.3 million.

Milk products.

As of December 31, 2022, expenses associated with the ongoing trials amounted globally to $

161.6 million, and we had non-cancellable contractual obligations with CRO until year ended 2025 amounting to $ 48.7 million.

Letter of Credit and Collateral

The Company signed with its bank CIC an acquisition contract of monetary market fund “SICAV CM-CIC”

pledged as a guarantee for the ordinary rental agreements of the leased premises in Bagneux for an amount of € 400 thousand (equivalent to $ 491 thousand at closing exchange rate).

A letter of credit has also been signed by the Company in April 2016 for $ 143 thousand to ensure the lease of its premises of its United States subsidiary.

This credit note has been extended in 2020 and 2021.

A letter of credit was also signed by the Company in May 2017 for $ 300 thousand to secure the lease of its premises of its United States subsidiary.

In 2015, the Company took a term deposit for a sum of € 228 thousand (equivalent to $ 259 thousand at closing exchange rate).

A Certificate of Deposit, for an initial amount of $ 250 thousand was signed in order to guarantee an American Express credit cards program in the United States.

Royalty Payments

On January 7, 2009, the Company entered into an assignment, development and co-ownership

agreement with Public Welfare-Hospitals of Paris (L’Assistance Publique—Hopitaux de Paris), or AP-HP,

and Université Paris-Descartes, or UPD, by which the Company agreed to terms of co-

ownership with AP-HP

and UPD of certain U.S.

and foreign patents and patent applications, referred to herein as the shared patents.

The Company, and any licensees or sublicensees the Company designates, have the exclusive right to commercial uses of the shared patents.

and UPD agreed to use the shared patents only for internal research purposes and not to license the shared patents to any third party.

Upon commercialization of any product covered by the shared patents, which the Company expects would include its Viaskin ™

product candidates, the Company will be obligated to

and UPD a percentage of net sales as a royalty.

This royalty varies depending on the particular patent used in the product and is in the

low single digits.

Additionally, if the Company licenses any of the shared patents to a third party and a licensee commercializes products covered by such shared patents, the Company will be obligated to pay AP-HP

and UPD a percentage in the low single digits of the money it receives from its licensee.

If the Company does not sell any of its product candidates covered by the shared patents within 30 months from the date it first markets such product

candidates, AP-HP

may, upon six months’ notice and subject to certain exceptions, convert its exclusive right to the commercial use of the shared patents to a non-exclusive

Any party may terminate the license in the event of another party’s substantial breach which remains uncured after six months of receiving written notice of such breach.

The agreement will also terminate in the event the Company ceases operations or is subject to a dissolution or bankruptcy proceedings.

Absent early termination, the agreement will automatically terminate upon the expiration of the last shared patent.

In the event the agreement is terminated, the Company would no longer have the exclusive right to commercial use of the shared patents, though it would retain its shared ownership rights.

In addition, its ownership stake in certain jointly made improvements covered by the shared patents would survive termination of the agreement.

The longest lived patent rights licensed to the Company under the agreement are currently expected to expire in 2033.

To date, this agreement has not had an impact on the Company’s financial statements.

A letter of credit was signed by the Company in May 2017 for $ 0.3 million to secure the lease of its premises of its United States subsidiary in New York.

A collateral of the same amount was signed in order to pledge against this letter of credit.

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

In 2015, the Company took a term deposit for a sum of € 0.23 million (equivalent to $ 0.24 million at closing exchange rate).

Note 18 Relationships with Related Parties

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Pension obligations

As of December 31, 2020, the amount of compensation included severance pay for Executive Committee members in connection with the restructuring announcement in June 2020.

Note 19 Loss Per Share

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The computations for basic and diluted loss per share were as follows (in thousands of U.S.

Dollars except per share data):

Dollars except share and per share data):

Weighted average number of ordinary shares

Basic and diluted net loss per share attributable to ordinary

shareholders ($/share)

Basic and diluted net loss per share attributable to ordinary shareholders ($/share)

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

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Restricted stock units

Prefunded warrants

Note 20 Events after the Close of the Fiscal Year

In 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 agreement provides for the termination of the lease effective on February 1, 2022, in exchange for a one-time

lump sum early termination fee.

Right of use and related lease debt will be adjusted in the 2022 financial period.

There are no significant events that require adjustments or disclosure in the consolidated financial statements.

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

What changed 10-K

Item 9A. Controls and Procedures