What changed in this filing

/stocks — the workspaceLOADING

Item 9A. Controls and Procedures

2022-03-09 compared with 2021-03-17 · 667 added, 958 removed, 597 unchanged (73% of the section changed)

1 unchanged sentence

Evaluation of Disclosure Controls and Procedures.

maintain disclosure controls and procedures, as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, that are designed to ensure

that information required to be disclosed in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the rules and forms of the Securities and Exchange

to management, including our chief executive officer (principal executive officer) and chief financial officer (principal financial officer), as appropriate, to allow timely decisions regarding required disclosure.

Our principal executive officer and principal financial officer evaluated the effectiveness of these disclosure controls and procedures and concluded that as

of December 31, 2020, our disclosure controls and procedures were effective.

Managements Report on Internal Control Over Financial

We maintain “disclosure controls and procedures,” as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the rules and forms of the Securities and Exchange Commission.

Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act is accumulated and communicated to management, including our chief executive officer (principal executive officer) and chief financial officer (principal financial officer), as appropriate, to allow timely decisions regarding required disclosure.

Our principal executive officer and principal financial officer evaluated the effectiveness of these disclosure controls and procedures and concluded that as of December 31, 2021, our disclosure controls and procedures were effective.

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.

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

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.

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.

A material weakness is a

deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the registrants annual or interim financial statements will not be

prevented or detected on a timely basis.

Based on this assessment, our management has concluded that our internal control over financial reporting was

effective as of December 31, 2020.

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.

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the registrant’s annual or interim financial statements will not be prevented or detected on a timely basis.

Based on this assessment, our management has concluded that our internal control over financial reporting was effective as of December 31, 2021.

As a smaller reporting company, our independent registered accounting firm is not required to issue an attestation report on our internal control over financial reporting.

Changes in Internal Control over Financial Reporting.

Following our global restructuring plan initiated in June 2020 (consisting of a reduction of more than 200 jobs, resulting in a remaining global team of 90

individuals) and potential associated disputes, our management has implemented incremental procedures and internal controls surrounding the review of our legal and contractual obligations towards our employees and their resulting accounting impacts.

In particular, management implemented a control with respect to the share-based plans consisting in the cross-functional and external legal review of each grants supporting documentation to secure consistent understanding of the vesting

conditions with management decision or intention and ensure that the vesting conditions as described in the plans supporting documentation and agreed by both Company and employee are correctly applied for the evaluation and recording of the

share-based payment expense.

This incremental control identified necessary adjustments, as described in Footnote 1 in the Notes to the Consolidated Financial Statements.

This specific control, the absence of which would have been considered as a

material weakness as of December 31, 2020, has been considered as effective as of December 31, 2020.

Except for the changes described

above, 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 year ended December 31, 2020 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 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the three months ended December 31, 2021 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Other Information.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.

Not applicable.

Directors, Executive Officers and Corporate Governance.

The information required by this Item 10 will be included in the sections titled Board of Directors and Corporate Governance and

Information About Our Executive Officers in our Proxy Statement and is incorporated herein by reference.

The information required by this Item 10 will be included in the sections titled “Board of Directors and Corporate Governance” and “Information About Our Executive Officers” in our Proxy Statement and is incorporated herein by reference.

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.

Security Ownership of Certain Beneficial Owners and Management

and Related Stockholder Matters.

The information required by this Item 12 will be included in the sections titled Security Ownership of

Certain Beneficial Owners and Management and Executive Compensation Plan Information 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” 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.

The information required by this Item 12 will be included in the sections titled “Security Ownership of Certain Beneficial Owners and Management” and “Executive Compensation” in our Proxy Statement and is incorporated herein by reference.

Certain Relationships and Related Transactions, and Director Independence.

The information required by this Item 13 will be included in the sections titled Board of Directors and Corporate Governance and

Transactions with Related Persons in our Proxy Statement and is incorporated herein by reference.

The information required by this Item 13 will be included in the sections titled “Board of Directors and Corporate Governance” and “Certain Relationships and Related Person Transactions” in our Proxy Statement and is incorporated herein by reference.

Principal Accountant Fees and Services.

The information required by this Item 14 will be included in Proposal 5 in the section titled

Independent Registered Public Account Firm Fees in our Proxy Statement and is incorporated herein by reference.

The information required by this Item 14 will be included in Proposal 5 in the section titled “Audit Fees and Services” in our Proxy Statement and is incorporated herein by reference.

Exhibits and Financial Statement Schedules.

1 unchanged sentence

(a)(1) Financial Statements

Reference is made to the financial

statements included in Item 8 of Part II hereof.

Reference is made to the financial statements included in Item 8 of Part II hereof.

(a)(2) Financial Statement Schedules

10 unchanged sentences

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

Commercial Lease between the registrant and SELECTINVEST 1, dated April 28, 2011 (English translation)

Assignment, Development and Co-Ownership Agreement among the registrant, LAssistance PubliqueHopitaux

de Paris and Université

Paris Descartes, dated January 7, 2009 (English translation)

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)

Development Collaboration and License Agreement between the registrant and NESTEC S.A., dated May 27, 2016

10 unchanged sentences

2017 Share Option Plan (English translation)

Incorporated by Reference

2017 Free Share Plan (English translation)

Incorporated by Reference

2018 Share Option Plan (English translation)

4 unchanged sentences

2020 Free Share Plan (English translation)

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

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

2021 Stock Option Plan (English translation)

2021 Free Share Plan (English translation)

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

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

Executive Agreement, dated July 22, 2019, between the registrant and Pharis Mohideen

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

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

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)

List of subsidiaries of the registrant

Consent of Deloitte & Associés and 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

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

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

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

Certification by the Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C.

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

XBRL Instance Document

XBRL Taxonomy Extension Schema Document

XBRL Taxonomy Extension Calculation Linkbase Document

Inline XBRL Instance Document

Inline XBRL Taxonomy Extension Schema Document

Incorporated by Reference

XBRL Taxonomy Extension Definition Linkbase Document

XBRL Taxonomy Extension Label Linkbase Document

XBRL Taxonomy Extension Presentation Linkbase Document

Inline XBRL Taxonomy Extension Calculation Linkbase Document

Inline XBRL Taxonomy Extension Definition Linkbase Document

Inline XBRL Taxonomy Extension Label Linkbase Document

Inline XBRL Taxonomy Extension Presentation Linkbase Document

Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101)

Filed herewith.

Furnished herewith and not deemed to be filed for purposes of Section 18 of the Securities

Exchange Act of 1934, as amended (the Exchange Act), and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the

Form 10-K), irrespective of any general incorporation language contained in such filing.

Furnished herewith and not deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Form 10-K), irrespective of any general incorporation language contained in such filing.

Indicates a management contract or any compensatory plan, contract or arrangement.

Confidential treatment has been granted from the Securities and Exchange Commission as to certain portions of

this document.

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to

be signed on its behalf by the undersigned, thereunto duly authorized.

Confidential treatment has been granted from the Securities and Exchange Commission as to certain portions of this document.

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

DBV Technologies S.A.

/s/ Daniel Tassé

Daniel Tassé

/s/ Daniel Tassé

Chief Executive Officer

1 unchanged sentence

March 9, 2022

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.

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 17, 2021.

/s/ Daniel Tassé

Daniel Tassé

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.

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 9, 2022.

/s/ Daniel Tassé

Chief Executive Officer and Director

( Principal Executive Officer

/s/ Sebastién Robitaille

Sebastién Robitaille

/s/ Sebastién Robitaille

Sebastién Robitaille

Chief Financial Officer

( Principal Financial and Accounting Officer

/s/ Torbjörn Bjerke

Torbjörn Bjerke

/s/ Michel de Rosen

2 unchanged sentences

Mailys Ferrere

/s/ Claire Giraut

Claire Giraut

/s/ Michael J.

1 unchanged sentence

Viviane Monges

/s/ Julie ONeil

/s/ Timothy E.

/s/ Adora Ndu

/s/ Julie O’Neill

Julie O’Neill

/s/ Ravi Madduri Rao

Ravi Madduri Rao

/s/ Daniel Soland

2 unchanged sentences

Annual Financial Statements for the Years Ended December 31, 2021 and 2020:

Report of Deloitte

& Associés and KPMG S.A., Independent Registered Public Accounting Firms on the year ended December 31, 2020

Report of Deloitte & Associés, Independent Registered Public Accounting

Firm on the year ended December 31, 2019

Report of Deloitte & Associés and KPMG S.A., Independent Registered Public Accounting Firms (Deloitte & Associés, Paris-La Défense, France, PCAOB ID No.

1756 ) (KPMG S.A., Paris-La Défense, France , PCAOB ID No.

Consolidated Statements of Financial Position as of December 31, 2021 and 2020

Consolidated Statements of Operations for the Years Ended December 31, 2020 and

Consolidated Statements of Comprehensive Loss for the Years Ended December 31,

2020 and 2019

Consolidated Statements of Operations and Comprehensive Loss for the Years Ended December 31, 2021 and 2020

Consolidated Statements of Cash Flows for the Years Ended December 31, 2021 and 2020

Consolidated Statements of Changes in Shareholders Equity for the Years

Ended December 31, 2020 and 2019

Consolidated Statements of Changes in Shareholders’ Equity for the Years Ended December 31, 2021

Notes to the Consolidated Financial Statements

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMS

REPORT OF INDPENDENT REGISTERED PUBLIC ACCOUNTING FIRMS

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

Opinion on the Consolidated Financial Statements

audited the accompanying consolidated statement of financial position of DBV Technologies S.A.

and subsidiaries (the Company) as of December 31, 2020, and the related consolidated statements of operations, comprehensive loss, cash flows

and changes in shareholders equity for the year ended December 31, 2020, 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, 2020, and the results of its operations and its cash flows for the year then ended, in conformity with accounting principles generally accepted in the United

States of America.

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.

Basis for Opinion

consolidated financial statements are the responsibility of the Companys management.

Our responsibility is to express an opinion on these consolidated financial statements based on our audit.

We are public accounting firms registered with the

Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S.

federal securities laws and the applicable rules and regulations of the

Securities and Exchange Commission and the PCAOB.

We conducted our audit in accordance with the standards of the PCAOB.

Those standards require that we

plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.

The Company is not required to have, nor were we engaged to perform, an

audit of its internal control over financial reporting.

As part of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the

Companys internal control over financial reporting.

These consolidated financial statements are the responsibility of the Company’s management.

Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits.

We are public accounting firms registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S.

federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB.

Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.

The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.

As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting.

Accordingly, we express no such opinion.

Our audit included performing procedures to assess the

risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks.

Such procedures included examining, on a test basis, evidence regarding the amounts and

disclosures in the consolidated financial statements.

Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial

We believe that our audit provides a reasonable basis for our opinion.

Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks.

Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements.

Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.

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

The communication of the 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.

Restricted stock units Refer to Notes 1 and 14 to

the consolidated financial statements

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 Matter Description

The Company grants restricted stock units to its employees.

Certain awards granted contain performance conditions.

The Company recognizes share-based payments

compensation over the requisite service period based

on the grant-date fair value, and when applicable, based upon the likelihood of achieving the performance condition.

The determination of the requisite service period and the estimate of awards

that are expected to vest depends on the legal interpretation of the award agreements with employees under the French labor laws and related jurisprudence.

Changes in interpretations could significantly impact the accounting for the share-based

payments as related to restricted stock units.

We identified the evaluation of the accounting for share-based payments as related to restricted stock

units as a critical audit matter because of the judgement required in the legal interpretation of the vesting conditions of the award agreements.

This required a high degree of auditor judgment, including the need to involve legal professionals with

specialized skills and knowledge when performing audit procedures to evaluate the reasonableness of managements accounting for share-based payments as related to restricted stock units.

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.

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 operating effectiveness of the internal control related to

the legal interpretation of the restricted stock units award agreements.

We evaluated, with the assistance of legal professionals with specialized skills and knowledge, the

reasonableness of the judgments made by the Company in the legal interpretation of the vesting conditions of the award agreements by reading the restricted stock unit plans and the other governing documents, including the shareholders meetings

minutes and Board of directors minutes, for each award granted as related to restricted stock units to evaluate whether the relevant terms and conditions impacting the interpretation of the award agreements were appropriately considered by the

We evaluated the adequacy of the Companys disclosures relating to share-based payments as related to

restricted stock units in the consolidated financial statements.

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.

/s/ Deloitte & Associés

2 unchanged sentences

We have served as the Company’s auditor since 2020.

Paris-La Défense, France

March 17, 2021

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

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

Opinion on the Consolidated Financial Statements

audited the accompanying consolidated statement of financial position of DBV Technologies S.A.

and subsidiaries (the Company) as of December 31, 2019, and the related consolidated statements of operations, comprehensive loss, cash flows

and changes in shareholders equity for the year ended December 31, 2019, 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, 2019, and the results of its operations and its cash flows for the year then ended, in conformity with accounting principles generally accepted in the United

States of America.

Basis for Opinion

consolidated financial statements are the responsibility of the Companys management.

Our responsibility is to express an opinion on these consolidated financial statements based on our audit.

We are a public accounting firm registered with the

Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S.

federal securities laws and the applicable rules and regulations of the Securities and

Exchange Commission and the PCAOB.

We conducted our audit in accordance with the standards of the PCAOB.

Those standards require that we plan and perform

the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.

Our audit included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud,

and performing procedures that respond to those risks.

Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements.

Our audit also included evaluating the accounting

principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.

We believe that our audit provides a reasonable basis for our opinion.

/s/ Deloitte & Associés

We have served as the Companys auditor since 2011.

Paris-La Défense, France

March 17, 2021

Défense, France

DBV Technologies S.A.

5 unchanged sentences

Trade receivables

Inventories and work in progress

Other current assets

3 unchanged sentences

Intangible assets

Other non-current assets

Total non-current assets

Liabilities and shareholders equity

Other non-current

Total non-current

Liabilities and shareholders’ equity

Current liabilities

7 unchanged sentences

Long-term financial debt

Non-current contingencies

Other non-current liabilities

Total non-current liabilities

contingencies

Other non-current

Total non-current

Total liabilities

1 unchanged sentence

Ordinary shares, € 0.10 par value;

54,929,187 and 47,028,510 shares authorized, and issued

as at December 31, 2020 and 2019, respectively, and 4,036,263 and 4,026,688 shares outstanding as at December 31, 2020 and 2019, respectively

Additional paid-in capital

Treasury stock, 102,302 and 41,159 ordinary shares as of December 31, 2020 and 2019,

respectively, at cost

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

Additional paid-in

Treasury stock, 153,631 and 102,302 ordinary shares as of December 31, 2021 and 2020, respectively, at cost

Accumulated deficit

2 unchanged sentences

Total shareholders’ equity

Total liabilities and shareholders equity

Total liabilities and shareholders’ equity

The accompanying notes are an integral part of these consolidated financial statements

DBV Technologies S.A.

Consolidated Statements of Operations

Consolidated Statements of Operations and Comprehensive Loss

(amounts in thousands, except share and per share data)

5 unchanged sentences

General & administrative expenses

Restructuring expenses

Restructuring reversal (expenses)

Total Operating expenses

Loss from operations

Financial expenses

Financial income (expenses)

Loss before taxes

Basic/diluted Net loss per share attributable to shareholders

Weighted average number of shares outstanding used in computing per share amounts:

The accompanying notes are an integral part of these consolidated financial statements

DBV Technologies S.A.

Consolidated Statements of Comprehensive Loss

(amounts in thousands)

Year Ended December 31,

Foreign currency translation differences, net of taxes

1 unchanged sentence

Total comprehensive loss

Basic/diluted Net loss per share attributable to shareholders

Weighted average number of shares outstanding used in computing per share amounts:

The accompanying notes are an integral part of these consolidated financial statements

18 unchanged sentences

Cash flows used in investing activities:

Acquisitions of property, plant, and equipment, net form proceeds

Acquisitions of property, plant, and equipment

Proceeds from property, plant, and equipment dispositions

Acquisitions of intangible assets

Acquisitions of non-current financial assets

Acquisitions of non-current

financial assets

Net cash flows used in investing activities

15 unchanged sentences

comprehensive

income (loss)

Balance at January 1, 2020

Other comprehensive income (loss)

Insuance of ordinary shares

Issuance of ordinary shares

Treasury shares

Share-based payments

Share-based payments (income) expenses

Balance at December 31, 2020

Other comprehensive income

Insuance of ordinary shares

Other comprehensive (loss)

Issuance of ordinary shares

Issuance of share warrants

Treasury shares

Share-based payments

Share-based payments (income) expenses

Allocation of accumulated net losses

Balance at December 31, 2021

The accompanying notes are an integral part of these consolidated financial statements

Notes to the Financial Statements

Notes to the Consolidated Financial Statements

Nature of the business and principles and accounting methods

Incorporated in 2002 under the laws of France, DBV Technologies S.A.

(DBV Technologies, or the Company, or we, or the

group) is a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin .

Companys therapeutic approach is based on epicutaneous immunotherapy, or EPITTM, a proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin .

(“DBV Technologies,” or the “Company”, or “we”, or the “group”) is a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin ™

The Company’s therapeutic approach is based on epicutaneous immunotherapy, or EPIT TM

, a proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin ™

Basis of Presentation

1 unchanged sentence

GAAP”) and presented in thousands of U.S.

Dollars, except for share and per share data and as otherwise noted.

Any reference in these notes to applicable guidance is meant to refer to authoritative U.S.

GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards

Update (ASU) of the Financial Accounting Standards Board (FASB).

GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).

We also follow the rules and regulations of the U.S.

Securities and Exchange Commission (“SEC”).

The Consolidated Financial Statements have been

prepared assuming the Company will continue as a going concern and using the historical cost principle with the exception of certain assets and liabilities that are measured at fair value in accordance with U.S.

The categories concerned are

detailed in the following notes.

The Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern and using the historical cost principle with the exception of certain assets and liabilities that are measured at fair value in accordance with U.S.

The categories concerned are detailed in the following notes.

Principles of Consolidation

The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries.

Intercompany transactions and

balances have been eliminated.

The following list presents all entities included in the consolidation scope for the year ended December 31, 2019 and

2020, as well as their country of incorporation and the percentage of ownership interests:

Intercompany transactions and balances have been eliminated.

The following list presents all entities included in the consolidation scope for the years ended December 31, 2020 and 2021, as well as their country of incorporation and the percentage of ownership interests:

DBV Technologies Inc.

was incorporated in Delaware on April 7, 2014 (the “US subsidiary”).

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

(DBV Technologies).

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

DBV Australia Pty Ltd.

was incorporated in New South Wales, Australia on July 3, 2018 (the Australian

subsidiary).

was incorporated in New South Wales, Australia on July 3, 2018 (the “Australian subsidiary”).

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

(“DBV Technologies”).

DBV Canada Ltd.

was incorporated in Ottawa, Ontario on August 13, 2018 (the Canadian

subsidiary).

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

(DBV Technologies).

DBV Pharma was incorporated in Paris on December 21, 2018 (the “French subsidiary”).

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

(DBV Technologies).

Functional Currency and

Translation of Financial Statements in Foreign Currency

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.

The statements of financial position of consolidated entities having a functional currency different from the presentation currency are translated at the closing exchange rate (spot exchange rate

at the statement of financial position date) and the statements of operations, statements of comprehensive loss and statements of cash flow of such consolidated entities are translated at the weighted average exchange rate.

The resulting translation

adjustments are included in equity under the caption Accumulated other comprehensive income (loss) in the Consolidated Statements of Changes in Shareholders Equity.

dollars, which differs from the functional currency of the Company, being the Euro.

The statements of financial position of consolidated entities having a functional currency different from the presentation currency are translated at the closing exchange rate (spot exchange rate at the statement of financial position date) and the statements of operations, statements of comprehensive loss and statements of cash flow of such consolidated entities are translated at the weighted average exchange rate.

The resulting translation adjustments are included in equity under the caption “Accumulated other comprehensive income (loss)” in the Consolidated Statements of Changes in Shareholders’ Equity.

Conversion of Foreign Currency Transactions

Foreign currency transactions are converted to functional currency of the entity at the rate of exchange applicable on the transaction date.

At period-end, foreign currency monetary assets and liabilities are converted at the rate of exchange prevailing on that date.

The resulting exchange gains or losses are recorded in the entity individual statements of

operations in Financial income (expense);

At period-end,

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

The resulting exchange gains or losses are recorded in the entity individual statements of operations in “Financial income (expense)”;

they will be recognized in profit or loss on disposal of the net investment.

Use of estimates

The preparation of the Companys Consolidated Financial Statements requires the use of estimates, assumptions and judgments that affect the

reported amounts of assets, liabilities, and disclosures of contingent assets and liabilities at the date of the consolidated financial statements and the reported amount of income and expenses during the period.

The Company bases its estimates and

assumptions on historical experience and other factors that it believes to be reasonable under the circumstances.

The preparation of the Company’s consolidated financial statements requires the use of estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, and disclosures of contingent assets and liabilities at the date of the consolidated financial statements and the reported amount of income and expenses during the period.

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

As of December 31, 2021, 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 assets - operating lease,

(4) impairment of right-of-use assets related to leases and property, plant and equipment, (5) recoverability of the Companys net deferred tax assets and

related valuation allowance, (6) assumptions used in the valuation model to determine the fair value of share-based compensation plan and, (7) estimate of contingencies.

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

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

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 dImpôt Recherche).

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.

These Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern.

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

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).

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.

Following receipt of a Complete Response Letter (“CRL”) from the U.S.

Food and Drug Administration (FDA) in connection with its Biologics License Application

(BLA) for Viaskin Peanut, beginning in August 2020, the Company scaled down its other clinical programs and pre-clinical spend to focus on Viaskin Peanut.

The Company also initiated a global restructuring plan in June 2020 to provide operational latitude to progress the clinical development and regulatory review of Viaskin Peanut in the United States and European Union.

Based on guidance received from the FDA in January 2021, the Companys plans to implement such guidance, and expected cost savings from

implementation of the global restructuring plan, the Company expects that its current balance of cash and cash equivalents of $196.4 million as of December 31, 2020 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

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 financings.

As a result of disruptions to the global financial markets as a result of the ongoing COVID-19 pandemic, 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 ongoing COVID-19 pandemic has 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 and on acceptable terms, if at all.

Food and Drug Administration (“FDA”) in connection with its BLA for Viaskin ™

Peanut, in August 2020, the Company scaled down its other clinical programs and pre-clinical

spend to focus on Viaskin ™

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

Peanut in the United States and European Union.

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.

In order to respond to the FDA’s requests and recommendations, the Company defined parallel workstreams primarily in order to generate the 6-month

safety and adhesion clinical data to assess a modified Viaskin Peanut patch and demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population.

Following the submission of the adhesion study’s protocol to the FDA, the Company received an Advice/Information Request letter from the FDA in October 2021, requesting a stepwise approach to the modified Viaskin patch development program and provided partial feedback on this protocol.

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.

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.

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 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

The ongoing COVID-19

pandemic has 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.

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.

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.

Intangible Assets

Acquired intangible assets are accounted for at acquisition cost less accumulated amortization.

Acquired intangible assets are mainly composed of software

amortized on a straight-line basis over their estimated useful lives comprised 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

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.

The costs related to the acquisition of licenses to software are posted to assets on the basis of the costs incurred to acquire and to implement the software.

Property, Plant, and Equipment

Property, plant, and

equipment are recorded at their acquisition cost.

Property, plant, and equipment are depreciated on the basis of the straight-line method over the

estimated use period of the property.

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.

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

7 unchanged sentences

Impairment of assets

Company periodically reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset is impaired or the estimated useful life is no longer appropriate.

If indicators of impairment

exist and the recoverable value of the asset on an undiscounted cash flow basis is less than the carrying amount, an impairment loss is recorded to the extent the carrying amount exceeds its fair value.

The Company periodically reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable or the estimated useful life is no longer appropriate.

If indicators of impairment exist and the recoverable value of the asset on an undiscounted cash flow basis is less than the carrying amount, an impairment loss is recorded to the extent the carrying amount exceeds its fair value.

Lease contracts

The Company determines whether an

arrangement is a lease at contract inception by establishing if the contract conveys the right to use, or control the use of, identified property, plant, or equipment for a period of time in exchange for consideration.

The Companys leases are

comprised of real estate leases, leases for industrial equipment and leases for office equipment.

The Companys real estate leases typically include

options and features including rent free periods, rent escalation periods, renewal options and early termination option.

The Company determines whether an arrangement is a lease at contract inception by establishing if the contract conveys the right to use, or control the use of, identified property, plant, or equipment for a period of time in exchange for consideration.

The Company’s leases are comprised of real estate leases, leases for industrial equipment and leases for office equipment.

The Company’s real estate leases typically include options and features including rent free periods, rent escalation periods, renewal options and early termination options.

The lease term is defined contract-by-contract

and corresponds to the non-cancelable period of the lease taking into account the optional periods that are reasonably certain to be exercised.

and corresponds to the non-cancelable

period of the lease taking into account the optional periods that are reasonably certain to be exercised.

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

The Company does not recognize a lease liability or right of use asset for leases with a term of 12 months or less, and it does not recognize a lease

liability or right of use asset for low value leases.

Operating lease right of use assets are presented as operating lease right of use assets on the

consolidated balance sheet.

To date, the Company has recognized a single lease cost under which the operating lease right of use and

liability are amortized on a straight-line basis over the lease term, and right of use and liability are categorized within Operating Expense in the Consolidated Statement of Operations.

operating lease cash flows are categorized under Net Cash Used in Operating Activities in the Consolidated Statement of Cash Flows.

The Company does not recognize a lease liability or right of use asset for leases with a term of 12 months or less.

Operating lease right of use assets are presented as operating lease right of use assets on the consolidated balance sheet.

To date, the Company has recognized a single lease cost under which the operating lease right of use and liability are amortized on a straight-line basis over the lease term, and categorized within Operating Expense in the Consolidated Statement of Operations.

The operating lease cash flows are categorized under Net Cash Used in Operating Activities in the Consolidated Statement of Cash Flows.

Variable costs are expensed in the period incurred.

Since the rate implicit in the lease is not readily determinable, the Company uses its incremental borrowing rates based on the information available at

commencement date in determining the discount rate used to calculate the present value of lease payments.

As the Company has no external borrowings, the incremental borrowing rates are determined using information on indicative borrowing rates that

would be available to the Company based on the value, currency and borrowing term provided by financial institutions, adjusted for company and market specific factors.

Since the rate implicit in the lease is not readily determinable, the Company uses its incremental borrowing rates based on the information available at commencement date in determining the discount rate used to calculate the present value of lease payments.

As the Company has no external borrowings, the incremental borrowing rates are determined using information on indicative borrowing rates that would be available to the Company based on the value, currency and borrowing term provided by financial institutions, adjusted for company and market specific factors.

Inventories and Work in Progress

Inventories are

measured at the lower of cost or net realizable value at production costs calculated using the first-in, first-out method.

It includes acquisition costs, processing

costs and other costs incurred in bringing the inventories to their present location and condition.

Inventories are exclusively composed of work in

progress relating to the production of the first batches that may be used for the commercialization.

During the launch phase of a new product, any

inventories of that product are written down to zero pending regulatory approval.

Inventories are measured at the lower of cost or net realizable value at production costs calculated using the first-in,

It includes acquisition costs, processing costs and other costs incurred in bringing the inventories to their present location and condition.

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

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

Financial Assets and Liabilities

Financial assets, excluding cash and cash equivalents, consist exclusively of other receivables.

Other receivables are

non-derivative financial assets with a payment, which is fixed or can be determined, not listed on an active market.

They are included in current assets, except those that mature more than twelve months after

the reporting date.

Other receivables are non-derivative

financial assets with a payment, which is fixed or can be determined, not listed on an active market.

They are included in current assets, except those that mature more than twelve months after the reporting date.

The recoverable amount of other receivables is estimated whenever there is an indication that the asset may be impaired and at least on each reporting date.

If the recoverable amount is lower than the carrying amount, an

impairment loss is recognized in the Consolidated Statements of Operation.

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.

If the recoverable amount is lower than the carrying amount, an impairment loss is recognized in the Consolidated Statements of Operations and Comprehensive Loss.

The Company also receives from time-to-time

assistance in the form of conditional advances, which are advances repayable in whole or in part based upon acknowledgment by the funder of a technical or commercial success of the related project by the funding entity.

The amount resulting from the deemed benefit of the interest-free nature of the award is considered a subsidy for accounting purposes.

This deemed benefit is determined by applying a discount rate equal to the rate of fungible treasury bonds over the time period that corresponds to the time period of the repayment of the advances.

In the event of a change in payment schedule of the stipulated repayments of the conditional advances, the Company makes a new calculation of the net book

value of the debt resulting from the discounting of the expected new future cash flows.

In the event of a change in payment schedule of the stipulated repayments of the conditional advances, the Company makes a new calculation of the net book value of the debt resulting from the discounting of the expected new future cash flows.

The adjustment that results therefrom is recognized in the income statement for the fiscal year during which the modification is recognized.

The Company carries its trade receivable at net realizable value.

On a periodic basis, the Company evaluates its trade receivable and determines whether to

provide an allowance or if any accounts should be written down and charged to expense as a bad debt.

On a periodic basis, the Company evaluates its trade receivable and determines whether to provide an allowance or if any accounts should be written down and charged to expense as a bad debt.

The Company generally does not require any security or collateral to support its receivables.

During the years ended December 31, 2020 and December 31, 2019, the Company did not hold any derivative financial instruments.

During the years ended December 31, 2021 and December 31, 2020, the Company did no t hold any derivative financial instruments.

Fair Value Measurements

Fair value is defined as an exit price, representing the amount that would be received upon the sale of an asset or payment to transfer a liability in an

orderly transaction between market participants.

Fair value is defined as an exit price, representing the amount that would be received upon the sale of an asset or payment to transfer a liability in an orderly transaction between market participants.

Fair value is a market-based measurement that is determined based on assumptions that market participants would use in pricing an asset or liability.

A three-tier fair value hierarchy is used to

prioritize the inputs in measuring fair value as follows:

Level 1 Quoted market prices (unadjusted) in active markets for identical assets or liabilities that

the reporting entity has the ability to access at the measurement date.

Level 2 Quoted market prices for similar assets or liabilities in active markets, quoted prices for

identical or similar assets or liabilities in markets that are not active, or other inputs that are observable, either directly or indirectly.

A three-tier fair value hierarchy is used to prioritize the inputs in measuring fair value as follows:

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

Level 2—Quoted market prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable, either directly or indirectly.

Fair value determined through the use of models or other valuation methodologies.

Level 3 Significant unobservable inputs for assets or liabilities that cannot be corroborated by

Level 3—Significant unobservable inputs for assets or liabilities that cannot be corroborated by market data.

Fair value is determined by the reporting entity’s own assumptions utilizing the best information available and includes situations where there is little market activity for the asset or liability.

The assets or liabilitys fair value measurement within the fair value hierarchy is based upon the lowest level of any input that is significant to

the fair value measurement.

The asset’s or liability’s fair value measurement within the fair value hierarchy is based upon the lowest level of any input that is significant to the fair value measurement.

The Company’s policy is to recognize transfers between levels of the fair value hierarchy in the period the event or change in circumstances that caused the transfer.

There were no transfers into or out of

Level 1, 2, or 3 during the periods presented.

The Company considers its cash and cash equivalents, accounts receivable and accounts payable to

reflect their fair value given their short maturity and risk profile of the counterparty.

There were no transfers into or out of Level 1, 2, or 3 during the periods presented.

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

Cash and Cash Equivalents

Cash includes cash on hand and demand deposits with banks.

Cash equivalents include short-term, highly liquid investments, with a 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 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.

Demand deposits therefore meet the definition of cash equivalents.

Cash equivalents are measured at fair value using level 1 and any

changes are recognized in the Consolidated Statements of Income.

Cash equivalents are measured at fair value using level 1 and any changes are recognized in the Consolidated Statements of Operations and Comprehensive Loss.

Concentration of Credit Risk

The Company has no significant off-balance sheet risk, such as foreign currency contracts, options contracts, or other

foreign hedging arrangements.

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 has 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.

Periodically, the Company maintains deposits in accredited financial institutions in excess of federally insured limits.

The Company deposits its cash in financial institutions that it believes have high credit quality and have not experienced any losses on such accounts and does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships or entities for which it has a receivable.

Share Capital

Ordinary shares are

classified under Shareholders Equity.

The costs of share capital transactions that are directly attributable to the issue of new shares or options are recorded in the Financial Statements in Shareholders Equity as a deduction from the

proceeds from the issue, net of tax.

Ordinary shares are classified under Shareholders’ Equity.

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

Employee benefits

Depending on the laws and practices of the countries in which the Company operates, employees may be entitled to compensation when they retire or to a pension

following their retirement.

For state-managed plans and other

defined contribution plans, the Company recognizes them as expenses when they become payable, with the Companys commitment being limited to our contributions.

Depending on the laws and practices of the countries in which the Company operates, employees may be entitled to compensation when they retire or to a pension following their retirement.

For state-managed plans and other defined contribution plans, the Company recognizes them as expenses when they become payable, with the Company’s commitment being limited to our contributions.

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

3 unchanged sentences

mortality tables.

The difference between the amount of the liability at the beginning of a fiscal year and at the close of that year is recognized through profit or loss for

the portion representing the costs of services rendered and through other comprehensive income (loss) for the portion representing the actuarial gains and losses.

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

Service costs are recognized in profit or loss and are allocated by function.

Actuarial gains and losses resulting from changes in actuarial assumptions and from differences between assumed and actual experience.

Gains and losses

recorded in other comprehensive income (loss) are amortized over expected remaining service periods to the extent they exceed 10% of the higher of the projected benefit obligation for the defined benefit plan.

The Companys payments for the defined-contribution plans are recognized as expenses on the statement of operations of the period with which they are

Actuarial gains and losses result from changes in actuarial assumptions and from differences between assumed and actual experience.

Gains and losses recorded in other comprehensive income (loss) are amortized over expected remaining service periods to the extent they exceed 10% of the projected benefit obligation for the defined benefit plan.

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

Contingencies

An estimated loss from a

loss contingency is recognized if the following two conditions are met:

information available before the financial statements are issued indicates that it is probable that an asset had

been impaired or a liability had been incurred at the date of the financial statements;

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

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

the amount of loss can be reasonably estimated.

With respect to litigations and claims that may result in a liability to be recognized, we exercise significant judgment in measuring and recognizing a

liability or determining exposure to contingent liabilities that are related to pending litigation or other outstanding claims.

With respect to litigations and claims that may result in a liability to be recognized, we exercise significant judgment in measuring and recognizing a liability or determining exposure to contingent liabilities that are related to pending litigation or other outstanding claims.

These judgment and estimates are subject to change as new information becomes available.

Operating Income

The Company accounts for revenue when

the amount can be reliably assessed, future economic benefits are likely to benefit the Company, and specific criteria are met for the Companys business, which is in accordance with ASC 606.

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

Other operating income

Research Tax Credit

The Research Tax Credit ( Cr é

dit d Imp ô

t Recherche ) is granted to companies by the

French tax authorities in order to encourage them to conduct technical and scientific research.

Companies that prove that they have expenditures that meet the required criteria receive a tax credit that can be used against the payment of the income

tax due for the fiscal year in which the expenditures were made and the next three fiscal years, or, as applicable, can be reimbursed for the excess portion.

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

only research expenses.

The repayable portion of the Research Tax Credit in more than one year is recorded in other

non-current assets.

Collaboration agreement with Nestlé

Health Science

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

payments and milestone payments.

Non-refundable upfront payments are deferred and recognized as income over the

period of the collaboration agreement.

Milestone payments represent amounts received depending upon the achievement of certain scientific, regulatory, or

commercial milestones.

They are recognized when the triggering event has occurred, there are no further contingencies or services to be provided with respect to that event, and the co-contracting party has no

right to require refund of payment.

The Research Tax Credit ( Crédit d’Impôt Recherche

) is granted to companies by the French tax authorities in order to encourage them to conduct technical and scientific research.

Companies that prove that they have expenditures that meet the required criteria receive a tax credit that can be used against the payment of the income tax due for the fiscal year in which the expenditures were made and the next three fiscal years, or, as applicable, can be reimbursed for the excess portion.

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

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

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

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.

Collaboration agreement with Nestlé Health Science

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

upfront payments and milestone payments.

Non-refundable

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

Milestone payments represent amounts received depending upon the achievement of certain scientific, regulatory, or commercial milestones.

They are recognized when the triggering event has occurred, there are no further contingencies or services to be provided with respect to that event, and the co-contracting

party has no right to require refund of payment.

The triggering event may be scientific results achieved by the Company or another party to the arrangement, regulatory approvals, or the marketing of products developed under the arrangement.

The Company recognizes income under the percentage-of-completion method.

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 15 Contingencies.

The Company recognizes income under the percentage-of-completion

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”.

Research and Development Expenditures

Research and development expenditures are charged to expense as costs are incurred in performing research and development activities.

Research and development

costs include all direct costs, including salaries, share-based payments and benefits for research and development personnel, outside consultants, costs of clinical trials, costs related to manufacturing clinical study materials, sponsored research,

clinical trials insurance, other outside costs, depreciation, and facility costs related to the development of drug candidates.

The Company records upfront, non-refundable payments made to outside vendors, or

other payments made in advance of services performed or goods being delivered, as prepaid expenses, which are expensed as services are performed or the goods are delivered.

Certain research and development projects are, or have been, partially funded by collaboration agreements, and the expenses related to these activities are

included in research and development costs.

Research and development costs include all direct costs, including salaries, share-based payments and benefits for research and development personnel, outside consultants, costs of clinical trials, costs related to manufacturing clinical study materials, sponsored research, clinical trials insurance, other outside costs, depreciation, and facility costs related to the development of drug candidates.

The Company records upfront, non-refundable

payments made to outside vendors, or other payments made in advance of services performed or goods being delivered, as prepaid expenses, which are expensed as services are performed or the goods are delivered.

Certain research and development projects are, or have been, partially funded by collaboration agreements, and the expenses related to these activities are included in research and development costs.

The Company records the related reimbursement of research and development costs under these agreements as income in the period in which such costs are incurred.

Please refer to Collaboration agreement with

Nestlé

Health Science for further detail.

Please refer to Collaboration agreement with Nestlé Health Science for further detail.

Share-based payments

Since its incorporation, the Company has established several plans for equity compensation issued in the form of employee warrants (bons de souscription de

parts de créateur dentreprise 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 dactions or BSAs) granted to non-employee members of the Board of Directors and members of the Scientific

Advisory Board.

Since its incorporation, the Company has established several plans for equity compensation issued in the form of employee warrants (bons de souscription de parts de créateur d’entreprise or “BCEs”), stock options (“SO”), and restricted stock units (“RSUs”) granted to employees and/or executives.

The company has also established several plans for equity compensation issued in the form of “share warrants” (bons de souscription d’actions or “BSAs”) granted to non-employee

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

These awards are measured at their fair value on the date of grant.

Except for RSUs, fair value is estimated using Black and Scholes

models that require inputs based on certain subjective assumptions, including the expected term of the award, and the conditions of each equity plan.

The fair value is amortized in personnel expenses (allocated by function in the Consolidated

Statements of Operations) on a straight-line basis over the requisite service period, and such expense is reduced for estimated forfeitures, with a corresponding increase in shareholders equity.

The determination of the requisite service period and the estimate of RSUs awards that are expected to vest depends on the legal interpretation of

the RSUs award agreements with employees under the French labor laws

and related jurisprudence.

Except for RSUs, fair value is estimated using Black and Scholes models that require inputs based on certain subjective assumptions, including the expected term of the award, and the conditions of each equity plan.

The fair value is amortized in personnel expenses (allocated by function in the Consolidated Statements of Operations and Comprehensive Loss) on a straight-line basis over the requisite service period, and such expense is reduced for estimated forfeitures, with a corresponding increase in shareholders’ equity.

The determination of the requisite service period and the estimate of RSUs awards that are expected to vest depends on the legal interpretation of the RSUs award agreements with employees under the French labor laws and related jurisprudence.

Changes in interpretations could significantly impact the accounting for the share-based payments.

At each closing date, the Company re-assesses the number of options expected to vest.

If applicable, the impacts of

such revised estimates are recognized in the Consolidated Statements of Operations, with a corresponding adjustment in shareholders equity.

awards are not subject to any market conditions.

In 2020, as the Company re-interpreted the vesting criteria for

several RSUs granted in 2017, 2018 and 2019, an immaterial adjustment of the Companys personnel expenses and net loss has been made in the financial statements prepared in accordance with IFRS, as filed in the Companys Annual Report on

Form 20-F for the year ended December 31, 2019, resulting in an additional expense of 5.2m ($6.2m) and 0.5m ($0.5m) for the years ended December 31, 2018 and 2019, respectively, with no

impact on the total shareholders equity for both periods.

These financial statements prepared in accordance with U.S.

GAAP as of and for the years

ended December 31, 2020 and 2019 reflect the re-interpreted vesting conditions for all periods presented.

Income taxes are accounted for under the

asset and liability method of accounting.

Deferred taxes are recognized for the future tax consequences attributable to temporary differences between the financial reporting carrying amounts and tax bases of assets and liabilities, and on tax

losses, using the liability method.

At each closing date, the Company re-assesses

the number of options expected to vest.

If applicable, the impacts of such revised estimates are recognized in the Consolidated Statements of Operations and Comprehensive Loss, with a corresponding adjustment in shareholders’ equity.

The awards are not subject to any market conditions.

Income taxes are accounted for under the asset and liability method of accounting.

Differences are defined as temporary when they are expected to reverse within a foreseeable future.

The Company may only recognize deferred tax assets on net operating losses if, based on the projected taxable

incomes within the next three years, management determines that it is probable that future taxable profit will be available against which the unused tax losses and tax credits can be utilized.

As a result, the measurement of deferred income tax

assets is reduced, if necessary, by a valuation allowance for any tax benefits which are not expected to be realized.

If future taxable profits are considerably different from those forecasted that support recording deferred tax assets, the Company

will have to revise downwards or upwards the amount of deferred tax assets, which would have a significant impact on the Companys financial results.

The Company may only recognize deferred tax assets on net operating losses if, based on the projected taxable incomes within the next three years, management determines that it is probable that future taxable profit will be available against which the unused tax losses and tax credits can be utilized.

As a result, the measurement of deferred income tax assets is reduced, if necessary, by a valuation allowance for any tax benefits which are not expected to be realized.

If future taxable profits are considerably different from those forecasted that support recording deferred tax assets, the Company will have to revise downwards or upwards the amount of deferred tax assets, which would have a significant impact on the Company’s financial results.

Tax assets and liabilities are not discounted.

Amounts recognized in the Consolidated

Financial Statements are calculated at the level of each tax entity included in the consolidation scope.

Deferred tax assets and liabilities are measured using the enacted tax rates expected to apply to taxable income in the years in which those

temporary differences are expected to be recovered or settled.

Amounts recognized in the Consolidated Financial Statements are calculated at the level of each tax entity included in the consolidation scope.

Deferred tax assets and liabilities are measured using the enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.

The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes are enacted.

Uncertain tax position

Tax benefits are recognized from

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

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

Segment Information

The Company operates in a single

operating segment:

The Company operates in a single operating segment:

the conducting of research and development of epicutaneous immunotherapy products in order to market them in the future.

1 unchanged sentence

Other Items in the Comprehensive Loss

Comprehensive

income 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.

These changes in

equity are presented net of tax.

These changes in equity are presented net of tax.

Net Loss Per Share

The Company calculates basic and diluted net loss per ordinary share by dividing the net loss by the weighted-average number of ordinary shares outstanding

during the period.

For the years ended December 31, 2020 and 2019, the Company has excluded the effects of all potentially dilutive shares, which include outstanding ordinary stock options, warrants to purchase ordinary shares, and restricted

stock units, from the weighted-average number of common shares outstanding as their inclusion in the computation for these years would be anti-dilutive due to net losses incurred.

The Company calculates basic and diluted net loss per ordinary share by dividing the net loss by the weighted-average number of ordinary shares outstanding during the period.

For the years ended December 31, 2021 and 2020, the Company has excluded the effects of all potentially dilutive shares, which include outstanding ordinary stock options, warrants to purchase ordinary shares, and restricted stock units, from the weighted-average number of ordinary shares outstanding as their inclusion in the computation for these years would be anti-dilutive due to net losses incurred.

Subsequent Events

The Consolidated Statements of

Financial Position and the Consolidated Statements of operations 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 17, 2021, the date at which the consolidated financial statements are issued.

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.

Accounting Pronouncements adopted in 2021

January 1, 2020, the Company adopted ASU 2018-13 Fair Value Measurement (Topic 820) - Disclosure Framework Changes to the Disclosure Requirements for Fair Value Measurement, which modifies

the disclosure requirements on fair value measurements in Topic 820, Fair Value Measurement.

The adoption of ASU 2018-13 did not have a material impact on the Companys financial position or results of

Effective January 1, 2020, the Company adopted ASU 2018-15 - Intangibles Goodwill and

Other Internal-Use Software (Subtopic 350-40) Customers Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service

Contract, which aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal use software license).

The guidance may be applied either retrospectively or prospectively to all implementation costs incurred after the date

The adoption of ASU 2018-15 did not have a material impact on the Companys financial position or results of operations.

Effective January 1, 2020, the Company adopted ASU 2018-18 Collaborative Arrangements Clarifying

the Interaction between Topic 808 and Topic 606, which clarifies that certain transactions between collaborative arrangement participants should be accounted for as revenue under Topic 606 when the collaborative arrangement participant is a customer

in the context of a unit of account.

In those situations, all the guidance in Topic 606 should be applied, including recognition, measurement, presentation, and disclosure requirements.

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.

Effective January 1, 2020, the Company adopted FASB issued ASU 2018 - 14, Compensation - Retirement Benefits - Defined Benefit Plans - General.

The purpose of this update is to modify disclosure requirements for Defined Benefit Plans.

It removes requirements to disclose the amounts in accumulated other comprehensive income expected to be recognized as components of net periodic benefit cost

over the next fiscal year among others.

It adds disclosure requirements for the items such as an explanation of the reasons for significant gains and losses related to changes in the benefit obligation for the period.

The adoption of ASU 2018-14 did not have a material impact on the Companys financial position or results of operations or on our disclosures.

Accounting Pronouncements issued not yet adopted

2016, the FASB issued ASU 2016-13 - Financial Instruments - Credit losses, which replaces the incurred loss impairment methodology for financial instruments in current U.S.

GAAP with a methodology that

reflects the Companys current estimate of expected credit losses to be incurred and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates.

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

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

GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates.

The FASB has issued ASU 2019-10

2019-10 which has resulted in the postponement of the effective date of the new guidance for eligible smaller reporting companies to the fiscal year

beginning after December 15, 2022 (January 1, 2023 for calendar year end companies).

The guidance must be adopted using a modified-retrospective approach and a prospective transition approach is required for debt securities for which

another-than-temporary impairment had been recognized before the effective date.

which has resulted in the postponement of the effective date of the new guidance for eligible smaller reporting companies to the fiscal year beginning January 1, 2023.

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 adoption is not expected to have a material impact on the

Companys financial position or results of operations.

In January 2017, the FASB issued ASU

2017-04, Simplifying the Test for Goodwill Impairment, which modifies the goodwill impairment test and requires an entity to write down the carrying value of goodwill for the amount by which the carrying

amount of a reporting unit exceeds its fair value.

The FASB has issued ASU 2019-10 which has resulted in the postponement of the effective date of the new guidance for eligible smaller reporting companies to

the fiscal year beginning January 1, 2023.

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

In December 2019, the FASB issued 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.

This guidance is effective for SEC filers

eligible to the smaller reporting company status for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020.

Early adoption is permitted.

The Company is currently evaluating but does not expect the new

guidance to 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 Companys Consolidated Financial Statements upon adoption.

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.

Note 2 Significant Events and Transactions of the Periods

Clinical programs

Viaskin TM Peanut for children ages 4-11

On October 4, 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 January 2020, the Company announced positive topline results of the three-year, open-label extension of its Phase III PEPITES trial, or PEOPLE trial,

evaluating the long-term efficacy and safety of investigational Viaskin Peanut in peanut-allergic children ages four to 11 years.

The results demonstrated long-term clinical benefit as shown by an increase in eliciting dose, or ED, which may

decrease the chance of reacting to an accidental peanut exposure.

After three years, the Company observed that 75.9% (107/141) of patients had increased their ED from baseline, and 51.8% (73/141) of patients reached an ED of at least 1,000 mg peanut

protein by year three.

The safety profile of Viaskin Peanut was consistent with that observed in the clinical program to date in over 1,000 patients.

During the PEOPLE trial, the most common adverse events were mild to moderate skin reactions

localized to the administration site, and there was no epinephrine use deemed related to treatment.

No treatment related serious adverse events were reported.

One patient experienced one case of mild anaphylaxis that was determined by the

investigator to be possibly related to treatment and resolved without treatment.

Treatment compliance remained high throughout the study at a mean of 98% over three years of treatment.

Low discontinuations due to adverse events were observed.

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 us that during its ongoing review of our 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.

On August 4, 2020, the Company announced that the U.S.

Food and Drug Administration (FDA) has issued a

Complete Response Letter 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.

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,

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.

On January 13, 2021, the Company received written responses from the FDA

to questions provided at the Type A meeting request the Company submitted in October 2020 following the CRL.

The Company believe the FDA feedback provides a well-defined regulatory path forward.

In exchanges with the FDA, the Company proposed

potential resolutions to two main concerns identified by the FDA in the CRL:

the impact of patch adhesion and the need for patch modifications.

The FDA agreed with our 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 1/1000 one peanut) remains unchanged and performs in the same way it has performed previously.

confirm the consistency of efficacy data between the existing and modified patches, FDA has requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages

The FDA also recommended conducting a 6-month, well-controlled safety and adhesion trial to assess the modified Viaskin Peanut patch in the intended patient

The Company intend to submit the protocols for the safety and adhesion study and the allergen uptake study to the FDA for review and comments in the second quarter of 2021 before initiating the trial.

The Company will address details

about a new human factor, or HF, validation study and additional CMC data in subsequent interactions with the FDA.

On November 2, 2020, the Company

announced that our 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 EMAs 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.

We expect to receive the first set of questions from the EMA approximately 120 days post-validation, during the first quarter of 2021.

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 m

g (approximately 1/1000 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 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.

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

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.

The Company prioritized the STAMP protocol submission so the Company could begin the study 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.

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

In May 2021, the Company submitted its proposed STAMP protocol to the FDA, and on October 14, 2021, the Company received an Advice/Information Request letter from the FDA.

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

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

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.

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.

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.

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.

It is a letter that is meant to include any remaining questions or objections at that stage in the process.

The EMA indicated many of their objections and major objections from the Day 120 list of questions had been answered.

One major objection remained at Day 180.

The Major Objection questioned the limitations of the data, for example, the clinical relevance and effect size supported by a single pivotal study.

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.

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

Viaskin Peanut for children ages 1-3

On June 26, 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

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.

The Company expects Part B of EPITOPE to be fully enrolled in by the end of the first

quarter of 2021.

2019, the Company announced the closing of an underwritten global offering of an aggregate of 6,000,000 ordinary shares reserved to specified categories of investors in (i) an offering of 2,447,500 ordinary shares in the form of 4,895,000

American Depositary Shares (ADSs) in the United States, Canada and certain other countries outside Europe, at an offering price of $6.75 per ADS (on the basis of an exchange rate of $1.1233 = 1.00), and (ii) a private

placement of 3,552,500 ordinary shares in Europe (including France), at an offering price of 12.02 per ordinary share.

Each ADS represents the right to receive one-half of one ordinary share.

proceeds to the Company from the global offering were approximately $81.0 million, before deducting underwriting commissions and estimated offering expenses.

On October 15, 2019, the Company announced the closing on October 11, 2019 of an underwritten global offering of an aggregate of 9,484,066 ordinary

shares reserved to specified categories of investors in (i) an

offering of 7,914,622 ordinary shares in the form of 15,829,244 American Depositary Shares (ADSs) in the United States, Canada and certain other countries outside Europe, at an offering price of

$6.59 per ADS (on the basis of an exchange rate of $1.0945 = 1.00), and (ii) a private placement of 1,569,444 ordinary shares in Europe (including France), at a public offering price of 12.04 per ordinary share.

The Company also

announced the closing on October 15, 2019 of 1,368,667 additional ordinary shares in the form of 2,737,334 ADSs, at an offering price of $6.59 per ADS, after full exercise of the underwriters option to purchase additional ordinary shares

in the form of ADSs (the Option).

The total gross proceeds from the global offering, after exercise of the Option, were approximately $143.0 million, before deducting commissions and estimated offering expenses.

On February 4, 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).

On March 2, 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).

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 approximately $160.7 million and net proceeds of $150.0 million.

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.

The company expects full implementation of the restructuring plan to result in a reduction of more than 200 jobs, resulting in a remaining global team of 90 individuals dedicated to the pursuit of innovation and scientific

development of novel therapies.

The Company expects full implementation of the organization-wide costs reduction measures to be completed by the second half of 2021.

The restructuring costs, accounted for $23.6 million as of December 31, 2020, are 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, 2020 included in the statement of operations:

Employee-related expenses

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

1 unchanged sentence

Total restructuring costs

The following table summarizes restructuring activities as of December 31, 2020 included in current

contingencies and other current liabilities on the statement of consolidated financial position:

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 liability —

January 1, 2020

Restructuring costs

Restructuring costs non-cash items

Restructuring liability - December 31, 2020

Restructuring costs —

non cash items

Restructuring liability —

December 31, 2020

of which current contingencies

of which other current liabilities

COVID-19 pandemic

On March 11, 2020, the outbreak of Covid-19 was declared a pandemic by the World Health Organization.

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

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.

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.

As of December 31, 2021, those uncertainties were taken into account in the assumptions underlying the estimates and judgments used by the Company.

The Company will continue to update these estimates and assumptions as the situation

The effects of the COVID-19 pandemic are presented in the relevant line items of the consolidated statement of financial position and the consolidated statement of operations according to the function

or nature of the income or expense.

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

The effects of the COVID-19

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

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 v.

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 alleged that the Company and its former Chief Executive

Officer, its current Chief Executive Officer, and its Deputy Chief Executive Officer violated certain federal securities laws, specifically under Sections 10(b) and 20(a) of the Exchange Act, and Rule 10b-5

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 purchasers of our securities between February 14, 2018 and March 16, 2020.

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

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

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.

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.

Note 3 Cash and Cash Equivalents

The following table

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

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

Cash equivalent

3 unchanged sentences

Cash equivalents are immediately convertible into cash at no or insignificant cost on demand.

measured using level 1 fair value measurements.

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 accounts receivable corresponds exclusively to the

amounts due under the license and collaboration agreement with Nestlé

Health Science.

Note 5 Inventories and Work in Progress

Inventory consisted of the following:

Inventories of raw materials

Work in progress

Impairment of inventories

Total net realizable value of the inventories

As of December 31, 2020, in accordance with industry practice, during the launch phase of a new product, any inventories

of that product are written down to zero pending regulatory approval.

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 5 Other Current Assets

Other current assets consisted of the following:

Research tax credit

Other tax claims

1 unchanged sentence

Other receivables

Research tax credit

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

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

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.

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

Opening balance sheet receivable as of January 1, 2020

+ 2020 fiscal year research tax credit

- Payment received

- Currency translation effect

Closing balance sheet receivable as of December 31, 2020

Current portion

Opening balance sheet receivable as of January 1, 2021

+ 2021 fiscal year research tax credit

- Payment received

- Adjustment and currency translation effect

Closing balance sheet receivable as of December 31, 2021

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.

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

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.

1 unchanged sentence

Property and equipment, net consisted of the following:

(Amounts in thousands of U.S.

Laboratory equipment

4 unchanged sentences

Less accumulated amortization and depreciation

(Amounts in thousands of U.S.

Laboratory equipment

4 unchanged sentences

Less accumulated amortization and depreciation

The depreciation and amortization expense for the years ended December 31, 2020 and 2019 was $4.4 million and

$3.3 million, respectively.

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.

For the year ended

December 31, 2020, amortization includes accelerated depreciation of PP&E linked with the early termination of several leases pursuant to restructuring.

Note 7 Lease contracts

The Company initiated a global

restructuring plan in June 2020 that involves a contemplated reduction in leased facilities.

The subsequent measurement of the useful life of the right-of-use assets related to each individual leases has highlighted:

a significant decrease of the period of time over which the related asset were expected to be used by the entity;

a significant decrease in need of space for the work force.

The Company therefore recognized on impairment of the right-of-use assets

related to leases.

Please refer to Note 2 Significant Events and Transactions of the Period Restructuring.

Future minimum lease payments under the Companys operating leases right of use as of

December 31, 2020 and 2019, are as follows:

Future minimum lease payments under the Company’s operating leases’ right of use as of December 31, 2021 and 2020, are as follows:

December 31, 2021

8 unchanged sentences

Weighted average discount rate

The Company recognizes rent expense, calculated as the remaining cost of the lease allocated over the remaining lease term on

a straight-line basis.

The Company recognizes rent expense, calculated as the remaining cost of the lease allocated over the remaining lease term on a straight-line basis.

Rent expense presented in the consolidated statement of operations and comprehensive loss was:

1 unchanged sentence

Restructuring expense

Supplemental cash flow information related to operating leases is as follows for the period December 31, 2020 and 2019:

Supplemental cash flow information related to operating leases is as

follows for the period December 31, 2021 and 2020:

Cash paid for amounts included in the measurement of lease liabilities

Operating cash flows from operating leases

Note 9 Other non-current assets

Other non-current assets consisted of the following:

Note 8 Other non-current

Other non-current

assets consisted of the following:

Research tax credit

Pledged securities

Deposits and other non-current financial assets

Deposits and other non-current

financial assets

Liquidity contract

Total other non-current assets

Research tax credit

Due to the loss of the Small and Medium-sized Enterprises status under EU law, the Research Tax Credit is repaid three

years after the tax declaration in the event the Company cannot offset it against corporate income tax due.

The repayable portion of the Research Tax

Credit in more than one year is recorded in other non-current assets.

The variance in Research Tax Credit during

the two years disclosed is presented as follow:

thousands of U.S.

Opening balance sheet receivable as of January 1, 2019

+ Research tax credit (operating income)

- Payment received

- Currency translation effect

Closing balance sheet receivable as of December 31, 2019

thousands of U.S.

Opening balance sheet receivable as of January 1, 2020

+ Research tax credit (operating income)

- Payment received

- Currency translation effect

Closing balance sheet receivable as of December 31, 2020

The non-current assets are also composed of portions repaid in more than one year of

research tax credit, security deposits paid to premises lessors, pledged securities not used as of December 31, 2020 and the liquidity contract.

Under the liquidity contract, 112,302 treasury shares were allocated as a reduction of Shareholders Equity as at December 31, 2020 with the cash

balance being maintained in financial assets.

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.

Under the liquidity contract, 153,631 treasury shares were allocated as a reduction of Shareholders’ Equity as at December 31, 2021 with the cash balance being maintained in financial assets.

Note 9 Trade payables and Other Current Liabilities

Trade Payables

No discounting

was performed on the trade payables to the extent that the amounts did not present payment terms longer than one year at the end of each fiscal year presented.

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

Other Current Liabilities

Other current liabilities consisted of the following:

Deferred incomes

Deferred income

Tax liabilities

The other current liabilities include short-term debt to employees including employee termination allowance

and benefits as part of the restructuring (Refer to Note 2, Significant Events and Transactions of the Period Restructuring), bonus accruals, as well as social welfare and tax agencies.

Deferred incomes mainly include deferred incomes from the collaboration agreement with Nestlé

Health Science, which amounted to $4.7 million as of

December 31, 2020.

Note 11 Financial debt and Other Non-Current Liabilities

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.

Note 10 Financial debt and Other Non-Current

Financial debt—Conditional Advances

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

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 01/01/2020

1 unchanged sentence

Balance sheet debt as at 12/31/2020

Of which - Non-current portion

Of which - Current portion

Current portion

Stated interest rate

4 unchanged sentences

Balance sheet debt as at 12/31/2021

Of which - Non-current portion

Of which - Current portion

Current portion

Stated interest rate

2 unchanged sentences

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.

Fourth OSEO Advance

In 2013, OSEO has provided assistance in the form of conditional advances as part of a collaborative research and clinical development in mite allergy in young

Following the defection of a sponsor, the ImmunaVia project was interrupted in September 2017.

The Company was required to reimburse the remaining amounts of conditional advances.

The reimbursement was rescheduled in 13 monthly repayments,

commencing on May 31, 2018, through May 31, 2019.

This agreement with OSEO terminated in 2019.

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.

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 Milk.

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

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

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

As of March 2, 2020, due to the COVID-19 pandemic, Bpifrance postponed the repayments for a 6-month period.

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 Companys liabilities (except leases disclosed in notes 8 Leae contract):

Short-term financial debt - Conditional advances

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

1 unchanged sentence

Total liabilities

As detailed in Note 10.2, the current portion of other liabilities mainly includes social security and deferred incomes from

the collaboration agreement with Nestlé

Health Science.

As detailed in Note 9, the current portion of other liabilities mainly includes social security and deferred incomes from the collaboration agreement with Nestlé Health Science.

Note 11 Fair value measurement

The Company reports assets and liabilities recorded at fair value on the Companys consolidated balance sheets based upon the level of judgment associated

with inputs used to measure their fair value.

The fair value measurement level within the fair value hierarchy for a particular asset or liability is

based on the lowest level of any input that is significant to the fair value measurement.

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

The fair value measurement level within the fair value hierarchy for a particular asset or liability is based on the lowest level of any input that is significant to the fair value measurement.

Valuation techniques maximize the use of observable inputs and minimize the use of unobservable inputs.

Financial instruments not measured at fair value on the Companys consolidated statement of financial position, but which require disclosure of their

fair values include cash and cash equivalents, accounts receivable, deposits, liquidity contract, accounts payable and conditional advances.

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

The fair values of these financial instruments are deemed to approximate their carrying amount.

The fair values of cash and cash equivalents, accounts receivable, deposits, liquidity contract and accounts payable are categorized as Level 1.

value of conditional advance was categorized as Level 2 and was estimated based on a discounted cash flow method using the effective interest rate.

For the interest-free conditional advances, the discount rate applied equal to the rate of

fungible treasury bonds over the time period that corresponds to the time period of the repayment of the advances.

The fair value of conditional advance was categorized as Level 2 and was estimated based on a discounted cash flow method using the effective interest rate.

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

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

1 unchanged sentence

Note 12 Share Capital Issued

The share capital, as of

December 31, 2020, is set at the sum of 5,492,918,70 ($ 6,518,498 converted at historical rates).

It is divided into 54,929,187 fully authorized, subscribed and paid-up shares with a nominal value

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 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.

The share capital, as of December 31, 2021, is set at the sum of € 5,509,576 ($ 6,537,591 converted at historical rates).

It is divided into 55,095,762 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”), employee warrants (“BCE”), 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.

The table below presents the changes in the share capital of the Company as of December 31, 2020 and 2021:

3 unchanged sentences

Share capital

Additional paid-in

Number of shares

Balance as of January 1, 2020

Capital increase by issuance of common shares

Fees charged to share premium

Capital increase by incorporation of reserve

Capital increase by issuance of common shares

Fees charged to share premium

Share-based payments

Balance as of December 31, 2019

Capital increase by employee warrants

8 unchanged sentences

Balance as of December 31, 2020

Capital increase by employee warrants

Retained earnings charged on share premium

Capital increase by employee warrants

Issuance of share warrants

Capital increase by ordinary shares

Share-based payments

Balance as of December 31, 2021

Conversion in U.S.

Dollars at historical rates

On April 8, 2019, the Company announced the closing of an underwritten global offering of an aggregate of 6,000,000 ordinary shares reserved to specified

categories of investors in (i) an offering of 2,447,500 ordinary shares in the form of 4,895,000 American Depositary Shares (ADSs) in the United States, Canada and certain other countries outside Europe, at an offering price of

$6.75 per ADS (on the basis of an exchange rate of $1.1233 =

1.00), and (ii) a private placement of 3,552,500 ordinary shares in Europe

(including France), at an offering price of 12.02 per ordinary share.

Each ADS represents the right to receive one-half of one ordinary share.

The gross proceeds to the Company from the global offering

were approximately $80.4 million (approximately 72.1 million), before deducting underwriting commissions and estimated offering expenses.

On October 15, 2019, the Company announced the closing on October 11, 2019 of an underwritten

global offering of an aggregate of 9,484,066 ordinary shares reserved to specified categories of investors in (i) an offering of 7,914,622 ordinary shares in the form of 15,829,244 American Depositary Shares (ADSs) in the United States, Canada

and certain other countries outside Europe, at an offering price of $6.59 per ADS (on the basis of an exchange rate of $1.0945 = 1.00), and (ii) a private placement of 1,569,444 ordinary shares in Europe (including France), at a public

offering price of 12.04 per ordinary share.

The Company also announced the closing on October 15, 2019 of 1,368,667 additional ordinary shares in the form of 2,737,334 ADSs, at an offering price of $6.59 per ADS, after full exercise of

the underwriters option to purchase additional ordinary shares in the form of ADSs (the Option).

The total gross proceeds from the global offering, after exercise of the Option, were approximately $143.0 million (approximately

130.7 million), before deducting commissions and estimated offering expenses.

On February 4, 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).

On March 2, 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

The Option closed on March 4, 2020.

Consequently, following partial exercise of the Option, which partial exercise closed on March 4, 2020, 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 approximately $160.7 million and net proceeds of $150.0 million.

In May 2021, pursuant to the authorization granted by the General Meeting of the Shareholders held on May 19, 2021, the accumulated net losses of DBV Technologies S.A.

after appropriation of the net result for the year ended December 31, 2020 have been allocated to additional paid-in

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

Note 13 Share-Based Payments

The Board of Directors has

been authorized by the General Meeting of the Shareholders to grant restricted stock units (RSU), stock options plan (SO), employee warrants ( Bons de Souscription de Parts de Créateur dEntreprise or

BSPCE) and (Bons de Souscription dActions or BSA), as follows:

General Meeting

Number granted

General Meeting

Number granted

General Meeting

The Board of Directors has been authorized by the General Meeting of the Shareholders to grant restricted stock units (“RSU”), stock options plan (“SO”), and non-employee

warrants (Bons de Souscription d’Actions or “BSA”), as follows:

General meeting of

Board of directors

Number granted

In the following tables in Notes 14.1 to 14.4, 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 grants.

14.1 Non- employee warrants

The Companys board of directors has been authorized by the shareholders general

meeting to grant BSA warrants (Bons de Souscription dActions or BSA) to non-employees members of the Board of Directors and members of the Scientific Advisory Board.

no longer grants BSA warrants since 2018.

The different employee warrants plans granted by the Board of Directors are similar in their nature and

conditions, except for the exercise price that is comprised between 5.13 and 69.75.

The following table summarizes all BSA warrants

activity during the year ended December 31, 2019:

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

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 .

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

These warrants have a contractual life of 4 years from their date of issuance and are not subject to a performance condition.

Unless otherwise decided by the Board of Directors, these warrants may be exercised at any time prior to their expiration, provided that the beneficiary still holds a seat on the Board of Directors at the time of exercise, and subject to applicable French laws and regulations applicable to companies whose securities are listed on a regulated stock market.

The fair value of the warrants has been estimated using the Cox-Ross

Rubinstein binomial option pricing model .

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

Weighted average share price at grant date (

Weighted average expected volatility

Weighted average risk-free interest rate

Weighted average expected term (in years)

Dividend yield

Weighted average fair value of warrants (

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

exercise price

intrinsic value

in thousands of

intrinsic value (in

Balance as of December 31, 2019

15 unchanged sentences

Warrants exercisable as of December 31, 2021

There were no BSA warrants granted during the years ended December 31, 2019 and 2020.

13.2 Employee warrants

Companys Board of Directors has been authorized by the shareholders general meeting to grant BCE warrants (Bons de Souscription de Parts de Créateur dEntreprise or BCE) to employees.

The Company no longer grants

BCE warrants since 2011.

Following the decision of the General Meeting of December 9, 2011, each BCE gives the right to subscribe to 15 shares

instead of 1 share.

The exercise price of each BCE has been adjusted accordingly and is therefore equal to 1/15th of the price initially set by the General Meeting.

The following table summarizes all BCE warrants activity during the year ended December 31, 2019:

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

8 unchanged sentences

Warrants exercisable as of December 31, 2020

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

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

exercise price

8 unchanged sentences

Warrants exercisable as of December 31, 2021

There were no BCE warrants grants during the years ended December 31, 2020 and 2019.

There were no

warrants grants during the years ended December 31

13.3 Stock options

The Companys

Board of Directors has been authorized by the shareholders general meeting to grant stock option plans (SO) to employees.

The different

stock options plans granted by the Board of Directors are similar in their nature and conditions, except for the exercise price that is comprised between 4,16 and 74,22.

All SO issued have a ten-year contractual life.

SO are expensed in accordance with the following vesting

Before June 22, 2018 and after January 15, 2020, SO granted mainly vest over four years at a

rate of 25% upon the first anniversary of the issuance date and 12,5% every 6 months thereafter, subject to the beneficiary being still employed by the Company (except in specific contractual clause or board of directors decisions),

Between June 22, 2018 and January 15, 2020, SO may be exercised by the beneficiary once both of the

following conditions have been met:

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

The different stock options plans granted by the Board of Directors are similar in their nature and conditions, except for the exercise price that is comprised between € 4.16 and € 74.22 .

All SO issued have a ten-year contractual

SO are expensed in accordance with the following vesting conditions:

Before June 22, 2018 and after January 15, 2020, SO granted mainly vest over four years at a rate of 25 % upon the first anniversary of the issuance date and 12.5 % every 6 months thereafter, subject to the beneficiary being still employed by the Company (except in specific contractual clause or board of directors’ decisions),

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

Service condition:

25% upon the first anniversary of the issuance date and 12,5% every 6 months thereafter,

subject to the beneficiary being still employed by the Company (except in specific contractual clause or board of directors decisions), and,

25% upon the first anniversary of the issuance date and 12.5% every 6 months thereafter, subject to the beneficiary being still employed by the Company (except in specific contractual clause or board of directors’ decisions), and,

Performance condition:

approval of Viaskin Peanut by

the US Food and Drug Administration,

Performance conditions which are other than market conditions, are taken into account by adjusting

the number of equity instruments included in the measurement of the transaction amount but are not taken into account when estimating the fair value of the shares.

approval of Viaskin ™

Peanut by the US Food and Drug Administration,

Performance conditions which are other than market conditions, are taken into account by adjusting the number of equity instruments included in the measurement of the transaction amount but are not taken into account when estimating the fair value of the shares.

Estimated achievement of performance conditions is reviewed at each reporting date.

The Company also applied a forfeiture rate for each grant according to its respective characteristics and composition.

This forfeiture rate is reviewed

at each reporting date.

This forfeiture rate is reviewed at each reporting date.

The following table summarizes all stock options activity during the year ended December 31, 2020:

15 unchanged sentences

Weighted-average

contractual term (in

contractual term

intrinsic value

7 unchanged sentences

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, 2020 was 5.54 per share.

As of December 31, 2020, there was 7.3 million

($9.0 million converted at closing rate) of unrecognized SO expense that is expected to be recognized over a weighted-average period of 1.8 years.

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

As of December 31, 2021, there was € 10.1 million ($ 11.4 million converted at closing rate) of unrecognized SO expense that is expected to be recognized over a weighted-average period of 2.9 years.

Fair value of stock options

Determining the fair value

of the share-based payments at the grant date requires judgment.

The Company calculated the fair value of stock options instrument on the grant date using the Black-Scholes option pricing model.

The Black-Scholes model requires the input of highly

subjective assumptions, including the expected volatility, expected term, risk-free interest rate and dividend yield.

Determining the fair value of the share-based payments at the grant date requires judgment.

The Company calculated the fair value of stock options instruments on the grant date using the Black-Scholes option pricing model.

The Black-Scholes model requires the input of highly subjective assumptions, including the expected volatility, expected term, risk-free interest rate and dividend yield.

Exercise price

1 unchanged sentence

Risk-free interest rate

The risk-free interest rate is

based on French government bonds (GFRN) with a maturity corresponding to the stock options maturity.

The risk-free interest rate is based on French government bonds (GFRN) with a maturity corresponding to the stock options maturity.

Expected term

1 unchanged sentence

Expected Volatility

The Company determines the expected

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

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

Expected Dividend yield

The Company has never declared or paid any cash dividends, and it does not presently plan to pay cash dividends in the foreseeable future.

Consequently, the

Company uses an expected dividend yield of zero.

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

Consequently, the Company uses an expected dividend yield of zero.

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

Assumptions per year ended, December 31,

Stock options per grant date

Prior to 2017

Weighted average shares price at grant date in €

5 unchanged sentences

13.4 Restricted stock units

The Companys board of directors has been authorized by the shareholders general meeting to grant Restricted stock units plans (RSU) to

RSUs are measured based on the fair market value of the underlying stock on the date of grant and recognized as expense on a straight-line

basis in accordance with the following vesting conditions:

Before May 31, 2019, the vesting of RSUs granted is subject to the expiration of the presence condition of one

(1) or two (2) years (except in specific board of directors decisions).

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

RSUs to employees.

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

Before May 31, 2019, the vesting of RSUs granted is subject to the expiration of the presence condition of one ( 1 ) or two ( 2 ) years (except in specific board of directors’ decisions).

The release of RSUs for these plans is subject to the achievement of performance conditions (submission of a BLA to U.S.

FDA for Viaskin Peanut, approval of Viaskin Peanut by the U.S.

FDA for Viaskin ™

Peanut, approval of Viaskin ™

Peanut by the U.S.

FDA, first sale of Viaskin ™

Peanut in the United States);

Between May 31, 2019 and November 23, 2020, the vesting of RSUs is subject either to the expiration of the

presence condition of two (2) years only, or to the dual condition of expiration of the presence condition and achievement of the performance condition (date of approval of Viaskin Peanut by

Since November 24, 2020, RSUs vest over four years at a rate of 25% upon the first

anniversary of the issuance date and 12,5% every 6 months thereafter, subject to the beneficiary being still employed by the Company (except in specific board of directors decisions).

Performance conditions, are other than market conditions, which are taken into account by adjusting the number of equity instruments included in the

measurement of the transaction amount but are not taken into account when estimating the fair value of the shares.

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

Peanut by the U.S.

Since November 24, 2020, RSUs vest over four years at a rate of 25 % upon the first anniversary of the issuance date and 12.5 % every 6 months thereafter, subject to the beneficiary being still employed by the Company (except in specific board of directors’ decisions).

Performance conditions, which are other than market conditions, are taken into account by adjusting the number of equity instruments included in the measurement of the transaction amount but are not taken into account when estimating the fair value of the shares.

Estimated achievement of performance conditions is reviewed at each reporting date.

1 unchanged sentence

The Company applied a forfeiture rate for each grant according to its respective characteristics and composition.

This forfeiture rate is reviewed at each

reporting date.

This forfeiture rate is reviewed at each reporting date.

The following table summarizes all RSUs activity for the year ended December 31, 2020:

6 unchanged sentences

Balance as of December 31, 2020

The service conditions have been met in 2019 for the plans granted on March 14, 2017, April 20, 2017, June 9 and 22, 2018,

November 1, 2018 and December 12, 2018 with a total fair value of 19,680 thousands.

The following table summarizes all RSUs activity for the year

ended December 31, 2020:

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:

average grant

5 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 1,288

As of December 31, 2020, there was 2.5 million ($3.0 million converted at closing rate)

of unrecognized RSUs compensation expense that is expected to be recognized over a weighted-average period of 2.2 years.

Reconciliation of the share-based payments expenses with the consolidated statements of operations

Research & development

Stock-options

Sales & marketing

Stock-options

General & administrative

Stock-options

Total share-based compensation (expense)

As of December 31, 2020, reversal of share-based payments expenses is mainly due to the restructuring plan announced on

June 26, 2020 which led to significant reduction in the Companys workforce.

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, 2021, there was € 2.5 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 2.4 years.

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

Research and development

Sales and marketing

General and administrative

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 14 Contingencies

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

contingencies and current contingencies break down as follows:

Current contingencies

Non-current contingencies

contingencies

Total contingencies

The table below shows movements in contingencies:

The table below shows movements

in contingencies:

Pension retirement

Collaboration

agreement—Loss at

Other contingencies

19 unchanged sentences

Of which Non-current

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

As of December 31, 2020, the Company updated its measurement of progress of the Phase 2 (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 Companys current best estimates of costs yet to be incurred and incomes yet to be

recognized for the completion of the PII.

Other contingencies are mainly composed of the estimated to be incurred as part of the social costs related to

restructuring, as well as estimated cost of refurbishing on lease premises (Refer to Note 2, Significant Events and Transactions of the PeriodRestructuring contingencies).

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

categories of employees:

The Company does not hold any plan assets for any

periods presented.

As of December 31, 2021, 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”).

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

% Social security contributions

4 unchanged sentences

Collective agreement

National Collective

pharmaceutical

National Collective Agreement of the pharmaceutical industry

Note 15 Operating Income

2 unchanged sentences

Other operating income

On May 31, 2016, the Company announced its entry into an exclusive global collaboration with Nestlé

Health Science

to develop MAG1C, a ready-to-use and standardized atopy patch test tool for the diagnosis of cows 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.

The Company entered into an amendment with Nestlé

Health Science on July 12, 2018.

The Company is eligible to receive up to

100.0 million in potential development, clinical, regulatory and commercial milestones, inclusive of a non-refundable upfront payment of 10.0 million that the Company received in July

In 2020, the ongoing COVID-19 pandemic impacted the Companys 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 a decrease in new patients enrolling in this Phase II clinical

trial and modified the protocols of the clinical trial.

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

Accordingly, as of December 31, 2020, the Company updated its measurement of progress of the 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 Companys current best estimates of costs yet to be incurred and incomes yet to be recognized

for the completion of the PII.

On May 31, 2016, the Company announced its entry into an exclusive global collaboration with Nestlé Health Science to develop MAG1C, a ready-to-use

and standardized atopy patch test tool for the diagnosis of cow’s milk protein allergy in infants and toddlers.

Under the terms of the exclusive collaboration, 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.

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

The Company is eligible to receive up to € 100.0 million in potential development, clinical, regulatory and commercial milestones, inclusive of a non-refundable

upfront payment of € 10.0 million that 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.

Note 16 Allocation of Personnel Expenses

The Company had 270 average employees as of December 31, 2020, in comparison with 319 employees at December 31, 2019.

The Company had 101 average employees for the year ended December 31, 2021, in comparison with 270 employees for the year ended December 31, 2020.

Allocation of Personnel Expenses by Function:

Research and Development expenses

Sales & Marketing expenses

General & Administrative expenses

Sales and Marketing expenses

General and Administrative expenses

Restructuring*

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.

Allocation of Personnel Expenses by Nature:

4 unchanged sentences

Share-based payments

The decrease in personnel charges is mainly due to a decrease headcount as well as accrued bonus, retention measures and

share-based compensation expenses, as part of the global restructuring plan.

The decrease in personnel expenses is mainly due to a decrease in headcount as well as accrued bonus, retention measures as part of the global restructuring plan.

Note 17 Income Tax

Reconciliation between the Effective and Nominal Income Tax Expense

The following table shows the reconciliation between the effective and nominal tax expense at the nominal standard French rate 28.0% as of December 31,

2020 and 2019 (excluding additional contributions):

The following table shows the reconciliation between the effective and nominal tax expense at the nominal standard French rate 26.5 % as of December 31, 2021 and 28 % as of December 31, 2020 (excluding additional contributions):

(Loss) before taxes

1 unchanged sentence

Nominal tax expense

I ncrease/decrease in tax expense arising from:

Increase/decrease in tax expense arising from:

Research tax credit

6 unchanged sentences

Effective tax rate

Given the Net operating losses generated over the past years by the Company and its subsidiaries, tax from

the year ended 2011 may be subject to examination by tax jurisdictions.

Deferred Tax Assets

Deferred taxes are recognized for temporary differences between the basis of assets and liabilities for financial statement and income tax purposes.

significant components of the Companys deferred tax assets are comprised of the following:

The significant components of the Company’s deferred tax assets are comprised of the following:

Deferred tax assets:

8 unchanged sentences

Purchase Obligations

The Company has signed

agreements with several contract research organizations (CRO) and part of the ongoing clinical studies for Viaskin Peanuts and

Viaskin Milk products, the Company.

As of December 31, 2020, we had non-cancellable contractual obligations with CRO until year ended 2023 for

$45.3 million.

The Company has signed agreements with several contract research organizations (CRO) and part of the ongoing clinical studies for Viaskin ™

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.

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

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 $280 thousand at closing exchange rate) over 3 years.

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

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 (LAssistance PubliqueHopitaux 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

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.

AP-HP 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 pay AP-HP 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 right.

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

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.

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 Companys financial statements.

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

Note 19 Relationships with Related Parties

The compensation amounts for 2021 presented below, which were awarded to the Directors and Officers of the Company totaled $ 7 million.

The recipients of

this compensation are related parties under applicable French law and may not be considered executive officers or related parties under comparable SEC and Nasdaq rules and regulations applicable to the Company.

The recipients of this compensation are “related parties” under applicable French law and may not be considered executive officers or related parties under comparable SEC and Nasdaq rules and regulations applicable to the Company.

Short-term benefits

1 unchanged sentence

Termination benefits

Share-based payment

Share-based payments

The methods for the valuation of the benefit related to share-based payments are presented in Note 13 Share-Based Payments.

A schedule of amounts payable to related parties:

Amounts payable to related parties as of December31, 2021 and 2020 are as follows:

Pension obligations

As of December 31, 2020, the amount of compensation included severance pay for Executive Committee members in connection

with restructuring announcement in June 2020.

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 20 Loss Per Share

The basic loss per share is calculated by dividing the net loss attributable to the shareholders of the Company by the weighted average number of ordinary

shares outstanding during the course of the fiscal year.

As the Company was in a loss position for the years ended December 31, 2020 and 2019, the diluted loss per share is equal to basic loss per share because of the effects of potentially

dilutive shares were anti-dilutive given the Companys net loss.

The computations for basic and diluted loss per share were as follows (in thousands

The basic loss per share is calculated by dividing the net loss attributable to the shareholders of the Company by the weighted average number of ordinary shares outstanding during the course of the fiscal year.

As the Company was in a loss position for the years ended December 31, 2021 and 2020, the diluted loss per share is equal to basic loss per share because the effects of potentially dilutive shares were anti-dilutive given the Company’s net loss.

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

Dollars except per share data):

Weighted average number of ordinary shares

Net loss per share attributable to ordinary shareholders, basic and diluted

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:

Non-employee warrants

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:

Employee warrants

2 unchanged sentences

Note 21 Events after the Close of the Fiscal Year

Clinical programs

On January 14, 2021, the

Company announced the receipt of written responses from the FDA to questions provided in the Type A meeting request the Company submitted in October 2020.

The FDA agreed with the Companys 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 1/1000 one peanut) remains unchanged and performs in the same way it has performed previously.

The FDA recommended conducting a 6-month, well-controlled

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

The Company has announced that it plans to initiate the selection of modified

prototype patches in the first quarter of 2021.

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.

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