What changed in this filing

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Item 9A. Controls and Procedures

2025-04-11 compared with 2024-03-07 · 491 added, 465 removed, 833 unchanged (53% of the section changed)

5 unchanged sentences

Management’s Report on Internal Control Over Financial Reporting.

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

effectiveness of our internal control over financial reporting.

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).

6 unchanged sentences

Changes in Internal Control over Financial Reporting.

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

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

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, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Other Information.

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

adopted, modified or terminated a “Rule

trading arrangement” or a

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

During the fiscal quarter ended December 31, 2024, none of our officers or directors, as defined in Rule 16a-1(f), adopted, modified or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” as those terms are defined in Item 408 of Regulation S-K.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.

Not applicable.

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

Certain information required by Part III is omitted from this report because we will file with the SEC a definitive proxy statement pursuant to Regulation 14A, the Proxy Statement, and/or an amendment to this Form 10-K under cover of Form 10-K/A, the 10-K/A, no later than 120 days after the end of our fiscal year, and certain information included therein is incorporated herein by reference.

Directors, Executive Officers and Corporate Governance.

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 10-K/A or in the sections titled “Board of Directors and Corporate Governance,” “Information About Our Executive Officers,” “Code of Business Conduct and Ethics” and “ Insider Trading Policy ” in our Proxy Statement and is incorporated herein by reference.

We intend to promptly disclose on our website or in a Current Report on Form 8-K in the future (i) the date and nature of any amendment (other than technical, administrative or other non-substantive amendments) to the Code of Conduct that applies to our principal executive officer, principal financial officer, principal accounting officer or controller or persons performing similar functions and relates to any element of the code of ethics definition enumerated in Item 406(b) of Regulation S-K and (ii) the nature of any waiver, including an implicit waiver, from a provision of the Code of Conduct that is granted to one of these specified individuals that relates to one or more of the elements of the code of ethics definition enumerated in Item 406(b) of Regulation S-K, the name of such person who is granted the waiver and the date of the waiver.

The full text of our Code of Conduct is available at the Investor Overview—Corporate Governance section of our website at www.dbv-technologies.com .

The reference to our website address does not constitute incorporation by reference of the information contained at or available through our website, and you should not consider it to be a part of this Annual Report.

Executive Compensation.

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

The information required by this Item 11 will be included in the 10-K/A or in the sections titled “Executive Compensation” (excluding the information under the subheading “Pay Versus Performance”) and “Board of Directors and Corporate Governance” in our Proxy Statement and is incorporated herein by reference.

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

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.

The information required by this Item 12 will be included in the 10-K/A or 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 “Certain Relationships and Related Person Transactions” in our Proxy Statement and is incorporated herein by reference.

The information required by this Item 13 will be included in the 10-K/A or 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 “Audit Fees and Services” in our Proxy Statement and is incorporated herein by reference.

The information required by this Item 14 will be included in the 10-K/A or in the section titled “Audit Fees and Services” in our Proxy Statement and is incorporated herein by reference.

Exhibits and Financial Statement Schedules.

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EXHIBIT INDEX

Incorporated by Reference

Exhibit Description Schedule/ Form File Number Exhibit File Date

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

4.1 Form of Deposit Agreement

Form F-1/A 333-198870 4.1 10/15/2014

F orm of Amendment No.

1 to Deposit Agreement

F orm of Amendment No.

2 to Deposit Agreement

Form of American Depositary Receipt

Form F-1/A 333-198870 4.1 10/15/2014

Description of Registered Securities

Form 20-F 001-36697 2.3 03/20/2020

Registration Rights Agreement, dated as of March 23, 2018, between the registrant, 667, L.P.

and Baker Brothers Life Sciences, L.P.

Form 6-K 001-36697 4.1 03/23/2018

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

Form 8-K 001-36697 10.2 06/13/2022

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

Form 8-K 001-36697 10.1 06/13/2022

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

Form 20-F 001-36697 4.2 04/29/2015

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

Form 10-K 001-36697 10.2 03/07/2024

10.3* Lease Agreement between DBV Technologies Inc.

and SIG 106 LLC, dated March 28, 2022

Form 10-K 001-36697 10.3 03/07/2024

10.4 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)

Form F-1 333-198870 10.2 09/22/2014

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

Form 20-F 001-36697 4.14 03/22/2017

10.5# Amendment to Development Collaboration and License Agreement between the registrant and NESTEC S.A., dated July 12, 20 1 8

Form 20-F 001-36697 4.5 04/01/2019

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

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

Form 10-K 001-36697 10.6 03/07/2024

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

Form F-1/A 333-198870 10.3 10/15/2014

10.8† 2013 and 2014 Share Option Plans (English translation)

Incorporated by Reference

Form F-1/A 333-198870 10.4 09/22/2014

10.9† 2012, 2013 and 2014 Free Share Plans (English translation)

Form F-1/A 333-198870 10.5 09/22/2014

10.10† Summary of BSA

Form F-1 333-198870 10.6 09/22/2014

10.11† Summary of BSPCE

Form F-1 333-198870 10.7 09/22/2014

10.12† 2015 Share Option Plan (English translation)

Form 20-F 001-36697 4.10 04/28/2016

10.13† 2015 Free Share Plans (English translation)

Form 20-F 001-36697 4.11 04/28/2016

10.14† 2016 Share Option Plan (English translation)

Form 20-F 001-36697 4.12 03/22/2017

10.15† 2016 Free Share Plan (English translation)

Form 20-F 001-36697 4.13 03/22/2017

10.16† 2017 Share Option Plan (English translation)

Form 20-F 001-36697 4.14 03/16/2018

10.17† 2017 Free Share Plan (English translation)

Form 20-F 001-36697 4.15 03/16/2018

10.18† 2018 Share Option Plan (English translation)

Form 20-F 001-36697 4.17 04/01/2019

10.19† 2018 Free Share Plan (English translation)

Form 20-F 001-36697 4.18 04/01/2019

10.20† 2019 Share Option Plan (English translation)

Form 20-F 001-36697 4.19 03/20/2020

10.21† 2019 Free Share Plan (English translation)

Form 20-F 001-36697 4.20 03/20/2020

10.22† 2020 Share Option Plan (English translation)

Form 10-K 001-36697 10.21 03/17/2021

10.23† 2020 Free Share Plan (English translation)

Form 10-K 001-36697 10.22 03/17/2021

10.24† 2021 Share Option Plan (English translation)

Form 10-K 001-36697 10.22 03/09/2022

10.25† 2021 Free Share Plan (English translation)

Form 10-K 001-36697 10.23 03/09/2022

10.26† 2022 Share Option Plan (English translation)

Form 10-K 001-36697 10.24 03/02/2023

10.27† 2022 Free Share Plan (English translation)

Form 10-K 001-36697 10.25 03/02/2023

10.28† 2023 Share Option Plan (English translation)

S-8 333-275662 99.3 11/20/2023

10.29† 2023 Free Share Plan (English translation)

S-8 333-275662 99.2 11/20/2023

10.30† 2024 Share Option Plan (English translation)

S-8 333-280657 99.1 07/30/2024

10.31† 2024 Free Share Plan (English translation)

S-8 333-280657 99.2 07/30/2024

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

Form 10-K 001-36697 10.23 03/17/2021

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

Form 10-K 001-36697 10.24 03/17/2021

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

Form 10-K 001-36697 10.25 03/17/2021

10.35† Letter Agreement, dated as of December 16, 2024, amending the Employment Agreement dated July 19, 2019, by and between registrant and Pharis Mohideen

Form 8-K 001-36697 10.1 12/16/2024

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

Form 10-K 001-36697 10.26 03/17/2021

Letter Agreement, dated December 1, 2019, between the registrant and Sébastien Robitaille (English translation)

Incorporated by Reference

Form 10-K 001-36697 10.26 03/17/2021

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

Form 10-K 001-36697 10.35 03/07/2024

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

Form 10-K 001-36697 10.36 03/07/2024

English Summary Translation of Letter Agreement dated as of December 16, 2024, amending the Employment Agreement dated November 6, 2023, by and between registrant and Virginie Boucinha

Securities Trading Policy

21.1*† List of subsidiaries of the registrant

Form 10-K 001-36697 21.1 03/07/2024

23.1* Consent of Deloitte & Associés

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31.1* 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 of 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

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

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97.1* Incentive Compensation Recoupment Policy, approved

Inline XBRL Instance Document

Inline XBRL Taxonomy Extension Schema 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

Form 10-K 001-36697 97.1 03/01/2024

101.INS* Inline XBRL Instance Document

101.SCH* Inline XBRL Taxonomy Extension Schema Document

101.CAL* Inline XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF* Inline XBRL Taxonomy Extension Definition Linkbase Document

101.LAB* Inline XBRL Taxonomy Extension Label Linkbase Document

101.PRE* Inline XBRL Taxonomy Extension Presentation Linkbase Document

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

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(Principal Executive Officer)

March 7, 2024

Date:April 11, 2025

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

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

Signature Title

/s/ Daniel Tassé

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/s/ Danièle Guyot-Caparros

Danièle Guyot-Caparros

Danièle Guyot-Caparro

/s/ Timothy E.

/s/ Adora Ndu

/s/ Julie O’Neill

12 unchanged sentences

Consolidated Statements of Changes in Shareholders’ Equity for the Years Ended December 31, 2024 and 2023

Notes to the Consolidated Financial Statements

Notes to the Consolidated Financial Statements F - 8

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMS

2 unchanged sentences

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

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

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

Going Concern

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

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

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

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

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

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

and subsidiaries (the “Company”) as of December 31, 2024 and 2023, the related consolidated statements of operations and comprehensive loss, cash flows and changes in shareholders' equity for the years then ended, 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, 2024 and 2023, and the results of its operations and its cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America.

Basis for Opinion

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Critical Audit Matter

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

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

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

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

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 Notes 1 and 20 to the consolidated financial statements

Critical Audit Matter Description

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The Company does not generate product revenue and continues to prepare for the potential launch of its first product in the United States and in the European Union, if approved.

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

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

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

On April 7, 2025, the Company received gross proceeds of $125.5 million (€116.3 million) from the issuance of the ABSA and PFW-BS-PFW, as described further in Note 20.

With the receipt of the aforementioned proceeds, and based on its current operations, plans, and assumptions, the Company estimates that its cash and cash equivalents are sufficient to fund its operations into June 2026.

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.

This matter required a high degree of subjective auditor judgment 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 evaluated the design of the internal control related to the Company’s going concern assessment;

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

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

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

/s/ Deloitte & Associés

/s/ Cédric Adens

The following are the primary procedures we performed to address this critical audit matter.

• We compared the Company’s historical forecasted operating expenses to actual results to assess the Company’s ability to accurately forecast.

• We performed a sensitivity analysis over the Company’s forecasted cash flows by evaluating the effect of changes to the forecasted operating expenses on the Company’s going concern assessment.

• We evaluated the reasonableness of the Company’s forecasted operating expenses by:

◦ inquiring of senior management to gain an understanding of the Company’s operations, strategy, and research and development activities;

◦ comparing the forecasted operating expenses to historical operating expenses;

◦ comparing forecasted operating expenses to management’s communications to the Board of Directors and public information disseminated by the Company.

• We assessed the adequacy of the Company’s disclosures related to its going concern assessment by comparing the disclosures to the audit evidence obtained.

/s/ Deloitte & Associés KPMG S.A.

/s/ Renaud Maxime Cambet

We have served as the Company’s auditor since 2011.

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

Défense, France

March 7, 2024

Paris-La Défense, France

April 11, 2025

DBV Technologies S.A.

1 unchanged sentence

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

Year ended December 31,

December 31, December 31,

Note 2024 2023

Current assets :

Cash and cash equivalents 3 $ 32,456 141,367

Trade receivables

Other current assets 4 11,932 17,548

5 unchanged sentences

Total non-current assets 21,271 24,071

Total Assets $ 65,658 182,986

Liabilities and shareholders' equity

2 unchanged sentences

Short-term operating leases 6 654 1,144

Short-term financial debt

Current contingencies 13 122 3,959

1 unchanged sentence

Total current liabilities 31,136 37,339

Non-current liabilities:

Long-term operating leases 6 6,297 4,526

Long-term financial debt

Non-current contingencies 13 838 935

Other non-current liabilities

Total non-current liabilities 7,135 5,461

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Ordinary shares, € 0.10 par value;

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

2023 and 2022, respectively

102,847,501 and 96,431,770 shares authorized, and issued as at December 31, 2024 and December 31, 2023, respectively,

$ 11,651 10,972

Additional paid-in capital 315,613 377,468

Treasury stock,

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

Treasury stock, 266,868 and 222,988 and ordinary shares as of December 31, 2024 and December 31, 2023, respectively, at cost

( 1,309 ) ( 1,263 )

Accumulated deficit ( 286,375 ) ( 238,862 )

2 unchanged sentences

Total Shareholders’ equity 11 $ 27,387 140,187

Total liabilities and shareholders’ equity

Total Liabilities and Shareholder's equity $ 65,658 182,986

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

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

Year ended December 31,

Twelve Months Ended December 31,

Operating income $ 4,151 15,728

1 unchanged sentence

Research and development expenses ( 89,342 ) ( 60,223 )

Sales & marketing expenses

General & administrative expenses

Sales and marketing expenses ( 2,659 ) ( 2,438 )

General and administrative expenses ( 28,739 ) ( 29,500 )

Total Operating expenses ( 120,740 ) ( 92,161 )

Loss from operations ( 116,589 ) ( 76,432 )

Financial income (expenses)

Financial income (expense) 2,726 3,714

Loss before taxes ( 113,863 ) ( 72,719 )

Income tax ( 55 ) ( 7 )

Net loss $ ( 113,918 ) ( 72,726 )

Foreign currency translation differences, net of taxes ( 4,222 ) 5,710

Actuarial gains on employee benefits, net of taxes 163 ( 38 )

Total comprehensive loss

Comprehensive loss $ ( 117,977 ) ( 67,054 )

Basic/diluted Net loss per share attributable to shareholders $ ( 1.17 ) ( 0.76 )

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

Weighted average shares outstanding used in computing per share amounts:

96,995,379 95,121,390

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

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(amounts in thousands

Year ended December 31,

Twelve Months Ended December 31,

Notes 2024 2023

Net loss for the period $ ( 113,918 ) ( 72,726 )

5 unchanged sentences

Changes in operating assets and liabilities:

Decrease (increase) in inventories and work in progress

Decrease (increase) in trade receivables

Decrease (increase) in other current assets 4,629 ( 3,795 )

(Decrease) increase in trade payables 272 8,420

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

(Decrease) increase in other current liabilities 366 ( 5,334 )

Change in operating lease liabilities and right of use assets 485 1,662

1 unchanged sentence

Cash flows used in investing activities :

Acquisitions of property, plant, and equipment

Proceeds from property, plant, and equipment dispositions

Acquisitions of intangible assets

Acquisitions of non-current financial assets

Proceeds from non-current

financial assets dispositions

Change in property, plant, and equipment ( 2,338 ) ( 677 )

Change in intangible assets ( 3 ) —

Change in non-current assets 1,584 ( 131 )

Net cash flows used in investing activities $ ( 757 ) ( 808 )

Cash flows provided by financing activities :

(Decrease) increase in conditional advances

Treasury shares ( 47 ) ( 154 )

Capital increases, net of transaction costs 634 6,921

Other cash flows related to financing activities

Net cash flows provided by financing activities 587 6,767

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Ordinary shares

comprehensive

Number of Shares Amount Additional paid-in capital Treasury stock Accumulated deficit Accumulated other comprehensive income (loss) Accumulated currency translation effect Total Shareholders’ Equity

Balance at December 31, 2022

Other comprehensive (loss)

94,137,145 10,720 458,221 ( 1,109 ) ( 259,578 ) 781 ( 14,581 ) 194,453

Net (loss) — ( 72,726 ) ( 72,726 )

Other comprehensive income (loss) — ( 38 ) 5,710 5,672

Issuance of ordinary shares 2,294,625 252 6,670 6,921

Issuance of share warrants

Treasury shares — ( 154 ) ( 154 )

Share-based payments (income) expenses

Share-based payments — 6,019 6,019

Allocation of accumulated net losses — ( 93,441 ) 93,441

Other change in equity

Balance at December 31, 2023

96,431,770 10,972 377,468 ( 1,263 ) ( 238,862 ) 742 ( 8,871 ) 140,187

Net (loss) — ( 113,918 ) ( 113,918 )

Other comprehensive income (loss) — 163 ( 4,222 ) ( 4,059 )

Issuance of ordinary shares 405,731 43 ( 43 )

Issuance of share warrants

Exercised share warrants 6,010,000 636 636

Treasury shares — ( 47 ) ( 47 )

Share-based payments (income) expenses

Share-based payments — 4,620 4,620

Allocation of accumulated net losses — ( 66,433 ) 66,433

1 unchanged sentence

Balance at December 31, 2024

102,847,501 11,651 315,613 ( 1,309 ) ( 286,375 ) 905 ( 13,097 ) 27,387

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

Notes to the Consolidated Financial Statements

Nature of the business and principles and accounting methods

Note 1 Nature of the business and principles and accounting methods

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

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

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

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

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

Basis of Presentation

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The Consolidated Financial Statements are presented in U.S.

dollars, which differs from the functional

of the Company, being the Euro.

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.

2 unchanged sentences

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)”;

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

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

The resulting exchange gains or losses are recorded in the Consolidated Statement of Operations and Comprehensive Loss in Operating income (expenses) or Financial income (expenses) depending on the nature of the underlying monetary item.

Use of estimates

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

On an on-going

basis, management evaluates its estimates, primarily those related to:

assets—operating lease, (4) impairment of right-of-use

assets related to leases and property, plant and equipment, (5) recoverability of the Company’s net deferred tax assets and related valuation allowance, (6) assumptions used in the valuation model to determine the fair value and vesting conditions of share-based compensation plan, and (7) estimate of provisions and contingencies.

On an on-going basis, management evaluates its estimates, primarily those related to:

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

Going concern

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

T hese 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 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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The Company cannot guarantee that it will be able to obtain the necessary financing to meet its needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets due to any future pandemics, epidemics or global health crises and conflict in Ukraine or other global political or military crises.

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

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

If the Company is not successful in its financing objectives, the Company could have to scale back its operations, notably by delaying or reducing the scope of its research and development efforts or obtain financing through

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

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.

The Company does not generate product revenue and continues to prepare for the potential launch of its first product in the United States and in the European Union, if approved.

Since its inception, the Company has primarily funded its operations through equity financings, as well as public assistance and Research Tax Credit.

Prior to 2022, the Company underwent restructuring efforts, scaled down certain clinical programs, and engaged with regulatory authorities to advance Viaskin Peanut’s approval process in the United States and European Union.

In 2022, the Company secured a private placement financing of $ 194 million and lifted a partial clinical hold from the FDA on its VITESSE Phase 3 clinical study.

On April 7, 2025, the Company received gross proceeds of $ 125.5 million (€ 116.3 million) from the issuance of the ABSA and PFW-BS-PFW, as described in Note 20.

With the receipt of the aforementioned proceeds, and based on its current operations, plans, and assumptions examined by the Board on March 23, 2025, the Company estimates that its cash and cash equivalents are sufficient to fund its operations into June 2026.

Given the Company’s historical operating losses and reliance on external financings, the Company may still seek additional capital for future needs through a combination of public or private equity or debt financings, collaborations, licensing agreements, and other funding options.

While recent financing events have improved the Company’s financial position, access to additional capital in the future remains subject to market conditions and investor interest.

Intangible Assets

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

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

and three years .

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

Intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.

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

PROPERTY, PLANT, AND EQUIPMENT ITEM PERIOD

Laboratory equipment and technical facilities

3 to 10 years

Building fixtures and leasehold improvements

Office equipment and furniture

Computer equipment

Property, plant, and equipment item period Depreciation

Laboratory equipment and technical facilities 3 to 10 years

Building fixtures and leasehold improvements 5 to 9 years

Office equipment and furniture 5 years

Computer equipment 3 years

Impairment of assets

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

During the years ended December 31, 2023 and December 31, 2022, the Company did no t hold any derivative financial instruments.

During the years ended December 31, 2024 and December 31, 2023, the Company did not hold any derivative financial instruments.

Fair Value Measurements

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Cash includes cash on hand and demand deposits with banks.

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

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

Demand deposits therefore meet the definition of cash equivalents.

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Research Tax Credit

The Research Tax Credit ( Crédit d’Impôt Recherche

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

The research tax credit ( crédit d’impôt recherche ) is granted to companies by the French tax authorities in order to encourage them to conduct technical and scientific research.

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

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

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

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

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

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

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

The expenditures taken into account for the calculation of the Research Tax Credit.

involve only research expenses.

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

During the year ended December 31, 2023, the Company received a reimbursement of $ 6.0 million for the 2022 fiscal year Research Tax Credit..

During the year ended December 31, 2024, the Company received a reimbursement for the 2023 fiscal year Research Tax Credit.

for a total amount of $ 8.7 million, included 2020, 2021 and 2022 complementary Research Tax Credit.

made during the fiscal year ended December 31, 2023.

Collaboration agreement with Nestlé Health Science

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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.

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

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

Until the Termination letter agreement signed on October 30, 2023, the Company recognized income under the percentage-of-completion

method, using costs incurred as the input method to determine progress towards the achievement of each milestone, and recognizing revenue based on costs incurred to date plus the estimate of margin at completion of the milestone.

Until the Termination letter agreement signed on October 30, 2023, the Company recognized income under the percentage-of-completion method, using costs incurred as the input method to determine progress towards the achievement of each milestone, and recognizing revenue based on costs incurred to date plus the estimate of margin at completion of the milestone.

The Company periodically updated its measurement of progress and updated its cumulative income recognized accordingly.

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

The Company records the

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

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

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

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

The company has also establish ed several

plans for equity compensation issued in the form of “share warrants” (bons de souscription d’actions or “BSAs”) granted to non-employee members of the Board of Directors and members of the Scientific Advisory Board.

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.

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

The Company has evaluated subsequent events from the balance sheet date through March 7, 2024, the date at which the consolidated financial statements are issued.

The Company has evaluated subsequent events from the balance sheet date through April 11, 2025, the date at which the consolidated financial statements are issued.

Accounting Pronouncements adopted in 2024

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

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

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

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.

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

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

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

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

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

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280) — Improvements to Reportable Segment Disclosures, which enables investors to better understand an entity's overall performance and assists with assessing potential future cash flows.

ASU 2023-07 expands public entities’ segment disclosures by requiring disclosure of significant segment expenses that are regularly provided to the Chief Operating Decision Maker (CODM) and included in the reported measure of segment profit and loss.

The Company adopted ASU 2023-07 in December 2024.

Refer to Note 21 - Reportable Segment Disclosure for further information.

Accounting Pronouncements issued not yet adopted

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.

In December 2023, the FASB issued ASU 2023-09, Income Taxes Topic 740 — Improvements to Income Tax Disclosures which enhances the transparency and usefulness of income tax disclosures.

This amendment requires disclosure of disaggregated information about the Company’s effective tax rate reconciliation as well as information on income taxes paid.

The disclosure requirements will be applied on a prospective basis, with the option to apply it retrospectively.

For SEC filers, this ASU is effective for fiscal years beginning after December 15, 2024.

The Company is currently evaluating the impact the adoption of this ASU will have on its consolidated financial statements and related disclosures.

In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income Topic 220 — Expense Disaggregation Disclosures.

The guidance requires disclosure of additional information about specific expense categories in the notes to financial statements at interim and annual reporting periods.

The disclosure requirements will be applied on a prospective basis, with the option to apply it retrospectively.

For SEC filers, this ASU is effective for fiscal years beginning after December 15, 2026 and interim periods within fiscal years beginning after December 15, 2027.

The Company is currently evaluating the impact the adoption of this ASU will have on its consolidated financial statements and related disclosures.

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

Note 2 Significant Events and Transactions of the Periods

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

g (approximately 1/1,000 of one peanut) remains unchanged and performs in the same way it has performed previously.

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

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

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

The FDA also recommended conducting a 6 -month,

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

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

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

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

Generate the 6-month safety and adhesion clinical data FDA requested via STAMP, which the Company expected to be the longest component of the mVP clinical plan.

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

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

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

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

safety and adhesion study.

The Company 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 six-month safety and adhesion study.

As such, in December 2021, the Company announced its plan to initiate a pivotal Phase 3 placebo-controlled efficacy trial for a modified Viaskin Peanut patch (mVP) in children in the intended patient population.

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The FDA confirmed the Company’s change in strategy was agreeable via oral and written exchanges.

In 2022, the Company announced the new Phase 3 pivotal study of the modified Viaskin Peanut (mVP) patch would be in younger (4-7

years old) and more sensitive children with peanut allergy.

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

On March 2, 2023, the Company announced the completion of EVOLVE, a 12-week caregiver and patient user experience study of the mVP patch in 50 peanut allergic children ages 4–11-years old.

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The COMFORT Toddlers safety study will enroll peanut allergic toddlers ages 1-3-years and will support the efficacy results generated from the EPITOPE Phase 3 pivotal study.

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

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

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

FDA agreed with a six-month study duration and a 3 :1 randomization (active:

placebo) of approximately 400 subjects in the double-blind, placebo-controlled COMFORT Toddlers study.

On March 24, 2025, the Company announced that in a Written Responses Only to the Company’s Type D IND meeting the FDA agreed with the Company’s proposal that the safety exposure data from the VITESSE Phase 3 study for Viaskin peanut patch in 4 – 7-year-olds will be sufficient to support a BLA filing in this age group.

As a result, the COMFORT Children supplemental safety study will no longer be required and the Company will not conduct the study.

The Company will utilize the safety data from the VITESSE participants randomized to active treatment as well as placebo-crossover participants in the VITESSE Open Label Extension (OLE).

Accordingly, the Company plans to submit a BLA in the first half of 2026 and anticipates potentially accelerating the product launch by approximately one year, subject to FDA approval.

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

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On December 20, 2021, the Company announced it withdrew the MAA for Viaskin Peanut and formally notified the EMA of our decision.

The initial filing was supported by data from a single, placebo-controlled Phase 3

pivotal trial known as PEPITES (V712-301).

The initial filing was supported by data from a single, placebo-controlled Phase 3 pivotal trial known as PEPITES (V712-301).

The decision to withdraw was based on the view of that the data available to date from a single pivotal clinical trial were not sufficient to preclude a Major Objection at Day 180 in the review cycle.

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Viaskin Peanut for Children ages 4-7

On September 7, 2022, we announced the initiation of VITESSE, a new Phase 3 pivotal study of the modified Viaskin Peanut (mVP) patch in children ages 4-7

years with peanut allergy.

On September 7, 2022, we announced the initiation of VITESSE, a new Phase 3 pivotal study of the modified Viaskin Peanut (mVP) patch in children ages 4-7 years with peanut allergy.

We defined initiation as the submission of the trial protocol to selected study sites for subsequent Institutional Review Board (IRB) approval and Ethics Committee (EC) opinion.

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

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

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

In addition, we continued internal preparations for VITESSE and conducted certain site assessment and start-up activities for prompt study launch once the partial clinical hold was lifted.

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

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

Screening of the last patient is anticipated by Q3 2024.

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

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

The additional safety data

generated by this

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

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

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

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

Topline results of VITESSE data are expected in the fourth quarter 2025.

As a result, the COMFORT Children supplemental safety study will no longer be required and the Company will not conduct the study.

The Company will utilize the safety data from the VITESSE participants randomized to active treatment as well as placebo-crossover participants in the VITESSE Open Label Extension (OLE).

Accordingly, the Company plans to submit a BLA in the first half of 2026 and anticipates potentially accelerating the product launch by approximately one year, subject to FDA approval.

Diagnostic Tool Development

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Consequently, since signing the Mutual Termination Letter Agreement and as of December 31, 2023, we recorded the following:

Loss on completion accrual reversal $ 19,9 millions (Other Operating Income);

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

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

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

In May 2022, the Company announced that pursuant to the Company’s At-The-Market program established in May 2022 (the “ATM Program”), it had issued and completed sales of new ordinary shares (the “Ordinary Shares”) in form of American Depositary Shares (“ADSs”), for a total gross amount of $ 15.3 millions

($ 14.1 millions

net of transaction costs).

In this context, 6,036,238 new Ordinary Shares in form of ADS have been issued through a capital increase without preferential subscription rights of the shareholders reserved to specific categories of persons fulfilling certain characteristics (the “ATM Issuance”), at a unit subscription price of 1.27 dollar per ADS (i.e., a subscription price per Ordinary Share of 2.41 euro based on the USD/EUR exchange rate of 1.0531 dollar for 1 euro, as published by the European Central Bank on May 4, 2022) and each ADS giving the right to receive one-half of one ordinary share of the Company.

Pursuant to the ATM program, the Company issued and completed sales of new Ordinary Shares in the form of ADSs for a total gross amount of $ 7.8 millions on June 14, 2023 (and a net amount of $ 6.9 millions after $ 0.9 capital increase fees imputation).

In June 2022, the Company announced an aggregate $ 194 million ($ 180.4 million net of transaction costs) private investment in public equity (PIPE) financing (corresponding to € 181 million on the basis of an exchange rate of $ 1.0739 = €1.00 published by the European Central Bank on June 8, 2022) from the sale of 32,855,669 ordinary shares, as well as pre-funded warrants to purchase up to 28,276,331 ordinary shares (the “June

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

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

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

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

In this context, 6,036,238 new Ordinary Shares in form of ADS have been issued through a capital increase without preferential subscription rights of the shareholders reserved to specific categories of persons fulfilling certain characteristics (the “ATM Issuance”), at a unit subscription price of 1.27 dollar per ADS (i.e., a subscription price per Ordinary Share of € 2.41 based on the USD/EUR exchange rate of 1.0531 dollar for 1 euro, as published by the European Central Bank on May 4, 2022) and each ADS giving the right to receive one-half of one ordinary share of the Company.

Pursuant to the ATM program, the Company issued and completed sales of new Ordinary Shares in the form of ADSs for a total gross amount of $ 7.8 million on June 14, 2023 (and a net amount of $ 6.9 million after $ 0.9 million capital increase fees imputation).

The ordinary shares were sold to the purchasers at a price per ordinary share of € 3.00 (corresponding to $ 3.22 ), and the pre-funded warrants were sold to the purchasers at a pre-funded price of € 2.90 (corresponding to $ 3.11 ) per pre-funded warrant, which equals the per share price for the ordinary shares less the remaining € 0.10 exercise price for each such pre-funded warrant.

Gross proceeds from the June 2022

PIPE total approximately $ 194 millions

(corresponding to € 181 millions

), before deducting private placement expenses.

The ordinary shares issued in the June 2022 PIPE, including the ordinary shares issuable upon exercise of the pre-funded

warrants from the PIPE financing, werenot been registered under the Securities Act of 1933, as amended, at the time of the offering, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements.

In connection with the PIPE financing, the Company entered into a registration rights agreement (the “Registration Rights Agreement”), pursuant to which the Company has filed a registration statement with the Securities and Exchange Commission (the “SEC”) registering the resale of

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

Gross proceeds from the June 2022 PIPE total approximately $ 194 million (corresponding to € 181 million), before deducting private placement expenses.

The ordinary shares issued in the June 2022 PIPE, including the ordinary shares issuable upon exercise of the pre-funded warrants from the PIPE financing, were not been registered under the Securities Act of 1933, as amended, at the time of the offering, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements.

Legal Proceedings

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

Cash 32,456 10,530

Cash equivalents — 130,836

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

Bank overdrafts

Total net cash and cash equivalents as reported in the statement of cash flow

Total cash and cash equivalents as reported in the statements of financial position 32,456 141,367

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

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Other receivables 1,959 1,353

Total 11,932 17,548

The other tax claims are primarily related to deductible VAT.

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

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

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

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

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

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

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

Opening balance sheet receivable as of January 1, 2022

+ 2022 fiscal year research tax credit

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

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

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

Amount in thousands of US Dollars

Opening research tax credit receivable as of January 1, 2023 5,792

+Operating revenue (1) 8,766

- Payment received ( 5,971 )

- Adjustment and currency translation effect 271

Closing balance sheet receivable as of December 31, 2022

Closing research tax credit receivable as of December 31, 2023 8,857

Of which - Non-current portion —

Of which - Current portion 8,857

Opening balance sheet receivable as of January 1, 2023

+ 2023 fiscal year research tax credit (1)

Amount in thousands of US Dollars

Opening research tax credit receivable as of January 1, 2024 8,857

+ Operating revenue 4,146

- Payment received ( 8,676 )

- Adjustment and currency translation effect ( 348 )

Closing balance sheet receivable as of December 31, 2023

Closing research tax credit receivable as of December 31, 2024 3,980

Of which - Non-current portion —

2 unchanged sentences

Note 5 Property, Plant, and Equipment

Property and equipment, net consisted of the follo wi

Reclassification

Property and equipment, net consisted of the following:

01/01/2023 Currency translation effect Additions Disposals Reclassification 31/12/2023

Laboratory equipment 20,459 815 — — 3,594 24,868

Building fixtures

Office equipment

Fixture and installations 2,999 106 — — — 3,105

Computer equipment 1,258 40 — — 126 1,425

Other property, plant and equipment 700 23 53 — — 775

Property, plant, and equipment in progress 4,467 91 625 — ( 3,720 ) 1,462

Less accumulated amort.

Reclassification

Total, gross 29,883 1,074 677 — — 31,635

Accumulated depreciation of laboratory equipment ( 10,825 ) ( 440 ) ( 2,275 ) — — ( 13,539 )

Accumulated depreciation of fixtures and installations ( 2,305 ) ( 93 ) ( 535 ) — — ( 2,933 )

Accumulated depreciation of computer equipment ( 1,134 ) ( 37 ) ( 91 ) — — ( 1,262 )

Accumulated depreciation of other property, plant and equipment ( 523 ) ( 30 ) ( 666 ) — — ( 1,219 )

Less accumulated amortization and depreciation ( 14,788 ) ( 600 ) ( 3,566 ) — — ( 18,954 )

Total, net 15,095 474 ( 2,889 ) — — 12,622

01/01/2024 Currency translation effect Additions Disposals Reclassification 31/12/2024

Laboratory equipment 24,868 ( 1,501 ) — — 388 23,726

Building fixtures

Office equipment

Fixture and installations 3,105 ( 116 ) 30 ( 3,042 ) 1,336 1,312

Computer equipment 1,425 ( 87 ) 1 — 451 1,789

Other property, plant and equipment 775 ( 42 ) — ( 7 ) 96 822

Property, plant, and equipment in progress 1,462 ( 77 ) 2,101 — ( 2,270 ) 1,185

Total, gross 31,635 ( 1,825 ) 2,132 ( 3,049 ) — 28,834

Accumulated depreciation of laboratory equipment ( 13,539 ) 901 ( 2,274 ) — — ( 14,912 )

Accumulated depreciation of fixtures and installations ( 2,933 ) 63 ( 271 ) 3,042 — ( 99 )

Accumulated depreciation of computer equipment ( 1,262 ) 68 ( 152 ) — — ( 1,346 )

Accumulated depreciation of other property, plant and equipment ( 1,219 ) 66 ( 24 ) 6 — ( 1,171 )

Less accumulated amortization and depreciation ( 18,954 ) 1,098 ( 2,721 ) 3,049 — ( 17,528 )

Total, net 12,622 ( 726 ) ( 589 ) — — 11,306

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

1 unchanged sentence

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

December 31, 2023

December 31, 2022

(Amounts in thousands of US Dollars) 31/12/2024 31/12/2023

Real Estate Other assets Total Real Estate Other assets Total

Current portion 810 26 836 1,205 79 1,284

Year 2 1,222 7 1,228 65 11 75

Year 3 1,230 7 1,237 421 — 421

Thereafter 5,127 9 5,136 5,515 — 5,515

Total minimum lease payments 8,388 49 8,437 7,205 90 7,295

Effects of discounting ( 1,463 ) ( 23 ) ( 1,486 ) ( 1,617 ) ( 9 ) ( 1,626 )

Present value of operating lease

Present value of lease liabilities 6,925 26 6,951 5,588 81 5,669

current portion ( 648 ) ( 6 ) ( 654 ) ( 1,072 ) ( 68 ) ( 1,144 )

Long-term operating lease

Long-term lease liabilities 6,278 20 6,297 4,516 13 4,526

Weighted average remaining lease term (years) 7.49 0.02 7.5 0.0

2 unchanged sentences

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

Operating lease expense

Refurbishing impact

(Amounts in thousands of US Dollars) 2024 2023

Operating lease expense / (income) 1,868 3,526

Net termination impact ( 52 ) ( 92 )

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

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

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

On March 28, 2022

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

3 years and 2 months .

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

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

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

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

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

1 unchanged sentence

The lease commencement was based upon delivery of possession of the premises by the Landlord and occurred in November 2023.

Right of use and related lease debt have been recorded starting November, 2023 for a gross amount of

$ 4.5 millions

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

Right of use and related lease debt have been recorded starting November 2023 for a gross amount of $ 4.5 million.

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

(Amounts in thousands of US Dollars) 2024 2023

Cash paid for amounts included in the measurement of lease liabilities — —

Operating cash flows from operating leases 1,053 1,956

Note 7 Other non-current

Note 7 Other non-current assets

Other non-current assets consisted of the following:

FX facility collateral account — 3,904

Deposits, pledged securities and other non-current financial assets

Deposits, pledged securities, prepaid expenses and other non-current financial assets 4,312 2,074

Liquidity contract 111 166

Total other non-current assets

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

Total non-current assets 4,423 6,144

The other non-current assets are composed of security deposits paid to premises lessors, pledged securities and the liquidity contract.

The collateral account to guarantee a FX facility is released as of December 31, 2024.

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

4 unchanged sentences

Other current liabilities consisted of the following:

Deferred income

Social debt 7,294 7,828

Tax liabilities 188 223

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

On October 30, 2023, the Company signed a

Termination letter agreement with

As of December 31

2023, we recorded

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

2.1 millions in current liabilities and $

4,7 millions in non current liabilities).

Note 9 Other Current and Non-Current

Other debts 846 883

Total 8,328 8,934

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

Note 9 Other Current Liabilities

Due dates of liabilities

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

Other current liabilities

Carrying 2025 2026 2027 2028 Thereafter

Other liabilities 8,328 8,328 — — — —

Supplier accounts payable and related payables 22,032 22,032 — — — —

Total liabilities

Total Other Current Liabilities 30,360 30,360 — — — —

The current portion of other liabilities mainly includes social security.

Other non-current

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

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

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

liabilities as of December 31, 2022).

Note 10 Fair Value Measurement

11 unchanged sentences

It is divided into 102,847,501 fully authorized, subscribed and paid-up shares with a nominal value of € 0.10 .

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

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

All the shares give their owners the right to a proportional share of the income and the net assets of the Company.

Pursuant to the authorization granted by the SH General Meeting, the Board of Directors, at its meeting of June 9, 2023 (the “Board General Meeting”):

decided, within the framework of the June 2022

PIPE the principle of a capital increase in cash with cancellation of preferential subscription rights, reserved for categories of persons meeting the characteristics set out in the 18 th

resolution of the Board General Meeting, through the issuance of Ordinary Shares and warrants to subscribe for Ordinary Shares, for a maximum amount of 6,113,200 New Ordinary Shares, corresponding to the maximum issue ceiling under the 22 nd

resolution of the Board General Meeting;

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

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

1 unchanged sentence

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

decided, making use of the 18 th

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

• decided, making use of the 18 th resolution of the Board General Meeting, to proceed with a capital increase in cash with cancellation of preferential subscription rights reserved for categories of investors, in accordance with the Article L.

225-128 of French Commercial Code, an amount of € 3,285,566.90 , through the issuance of (i) 32,855,669 New Ordinary Shares, to be subscribed in cash at a unit price of € 2.90 of share premium and to be fully paid up at the time of subscription, i.e.

1 unchanged sentence

a gross amount of the capital increase of € 98,567,007 , and (ii) 28,276,331 prefunded warrants to be subscribed in cash by paying up on the date of issue of € 82,001,359.90 corresponding to the prepayment of the subscription price of the new ordinary shares in the event of exercise of the prefunded warrants;

decided to set the maximum nominal amount of the capital increase resulting from the full exercise of the prefunded warrants at € 2,827,633.10 , by issuing a maximum of 28,276,331 ordinary shares, with a value of € 0.10 to be subscribed in cash at the price of € 0.10 euro (without share premium), and to be fully paid up at the time of subscription, i.e.

• decided to set the maximum nominal amount of the capital increase resulting from the full exercise of the prefunded warrants at € 2,827,633.10 , by issuing a maximum of 28,276,331 ordinary shares, with a value of € 0.10 to be subscribed in cash at the price of € 0.10 (without share premium), and to be fully paid up at the time of subscription, i.e.

a capital increase of a maximum nominal amount of € 2,827,633.10 (and a share premium corresponding to the amount of the pre-financed price released in advance at the time of the subscription of the prefunded warrants ), being specified that this amount does not take into account the nominal value of the ordinary shares to be issued in order to preserve the rights of the holders of securities giving access to the capital issued or to be issued, in accordance with the legal and regulatory provisions and the contractual stipulations providing for other cases of adjustment if necessary;

determined the list of beneficiaries (designated within each of the categories of persons defined in the 18 th

resolution of the Board General Meeting) and the number of New Ordinary Shares and warrants allocated to each of them under the conditions defined in the 18 th

resolution of the Board General Meeting beneficiaries under the conditions defined in section 5 of the offering circular relating to the June 2022 PIPE.

The Company has assessed the pre-funded

warrants for appropriate equity or liability classification.

During this assessment, the Company determined the pre-funded

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

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

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

The Company has assessed the pre-funded warrants for appropriate equity or liability classification.

During this assessment, the Company determined the pre-funded warrants are freestanding instruments that do not meet the definition of a liability pursuant to ASC 480 and do not meet the definition of a derivative pursuant to ASC 815.

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

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

1 unchanged sentence

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

Prefunded warrants

Balance as of December 31, 2023 28,276,331

7 unchanged sentences

Dollars except share and per share data)

Nature of the transactions

Share capital*

Balance as of December 31, 2021

Share capital in USD* Additional paid-in capital Number of shares

Date Nature of the transactions

Balance as of January 1, 2023 10,720 458,220 94,137,145

03/23/2023 Capital increase by employee warrants 1 ( 1 ) 10,174

04/12/2023 Retained earnings charged on share premium ( 93,441 )

05/19/2023 Capital increase by ordinary shares 0 0 2,500

05/22/2023 Capital increase by ordinary shares 2 ( 2 ) 14,374

05/24/2023 Capital increase by ordinary shares 4 ( 4 ) 34,321

06/16/2023 Capital increase by ATM program 225 6,696 2,052,450

Retained earnings charged on share premium

Capital increase by employee warrants

09/23/2023 Capital increase by ordinary shares 0 0 2,599

Capital increase by share warrants

Capital increase by employee warrants

10/25/2023 Capital increase by ordinary shares 4 ( 4 ) 35,000

2 unchanged sentences

11/22/2023 Capital increase by ordinary shares 6 ( 6 ) 50,058

11/24/2023 Capital increase by ordinary shares 4 ( 4 ) 32,884

12/31/2023 Share-based payments 6,020

Balance as of December 31, 2023 10,972 377,468 96,431,770

Capital increase by employee warrants

03/23/2024 Capital increase by ordinary shares 0 0 2,599

05/12/2024 Capital increase by ordinary shares 0 0 1,600

05/16/2024 Retained earnings charged on share premium ( 66,433 )

2 unchanged sentences

05/24/2024 Capital increase by ordinary shares 4 ( 4 ) 32,497

Capital increase by ATM program

07/29/2024 Capital increase by ordinary shares 1 ( 1 ) 5,849

09/23/2024 Capital increase by ordinary shares 0 — 2,599

11/15/2024 Capital increase by employee warrants 636 — 6,010,000

11/18/2024 Capital increase by ordinary shares 0 — 400

2 unchanged sentences

11/21/2024 Capital increase by ordinary shares 18 ( 18 ) 166,874

11/22/2024 Capital increase by ordinary shares 2 ( 2 ) 21,925

11/24/2024 Capital increase by ordinary shares 5 ( 5 ) 46,840

12/31/2024 Share-based payments 4,620

Balance as of December 31, 2024 11,651 315,613 102,847,501

In April 2023, pursuant to the authorization granted by the General Meeting of the Shareholders held on April 12, 2023, the accumulated net losses of DBV Technologies S.A.

after appropriation of the net result for the year ended December 31, 2022 have been allocated to additional paid-in

capital in the amount of

millions converted at historical rates).

* Conversion at historical rate

In May 2024, pursuant to the authorization granted by the General Meeting of the Shareholders held on May 16, 2024, the accumulated net losses of DBV Technologies S.A.

after appropriation of the net result for the year ended December 31, 2023 have been allocated to additional paid-in capital in the amount of $ 66.4 million (€ 61.1 million converted at historical rates).

Note 12 Share-Based Payments

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

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

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:

Share-based payments instrument General meeting of shareholders Board of directors meeting Grant date Number granted

BSA 12/9/2011 9/25/2012 9/25/2012 30,000

BSA 6/4/2013 7/25/2013 7/25/2013 73,000

SO 12/9/2011 9/18/2013 9/18/2013 518,000

BSA 6/3/2014 3/24/2015 3/24/2015 10,000

SO 6/3/2014 6/23/2015 6/23/2015 120,000

BSA 6/23/2015 11/19/2015 11/19/2015 22,500

BSA 6/23/2015 12/15/2015 12/15/2015 90,000

SO 6/3/2014 4/6/2016 4/21/2016 33,000

SO 6/3/2014 6/21/2016 6/21/2016 110,000

BSA 6/21/2016 6/21/2016 8/21/2016 20,000

SO 6/3/2014 6/21/2016 9/15/2016 93,000

SO 6/3/2014 6/21/2016 10/17/2016 16,500

BSA 6/21/2016 12/9/2016 12/9/2016 59,000

SO 6/3/2014 12/9/2016 12/9/2016 74,960

AGA 9/21/2015 3/14/2017 3/14/2017 22,500

AGA 9/21/2015 4/20/2017 4/20/2017 24,000

BSA 6/15/2017 6/15/2017 6/15/2017 9,000

SO 6/3/2014 6/15/2017 6/15/2017 126,000

SO 6/15/2017 6/15/2017 6/15/2017 111,600

SO 6/15/2017 6/15/2017 9/15/2017 52,600

SO 6/15/2017 11/17/2017 12/5/2017 625,200

BSA 6/15/2017 5/2/2018 5/2/2018 44,000

AGA 6/22/2018 6/22/2018 6/22/2018 486,153

AGA 6/22/2018 9/6/2018 9/6/2018 450

SO 6/22/2018 9/6/2018 9/6/2018 65,000

SO 6/22/2018 6/22/2018 10/15/2018 76,700

AGA 6/22/2018 11/1/2018 11/1/2018 57,000

SO 6/22/2018 11/29/2018 11/29/2018 350,000

AGA 6/22/2018 12/12/2018 12/12/2018 16,250

SO 6/22/2018 6/22/2018 1/15/2019 3,000

SO 6/22/2018 6/22/2018 3/20/2019 547,100

AGA 6/22/2018 5/10/2019 5/10/2019 100,000

SO 5/24/2019 5/24/2019 5/24/2019 150,000

SO 5/24/2019 5/24/2019 7/1/2019 403,400

SO 5/24/2019 5/24/2019 7/22/2019 75,000

AGA 5/24/2019 10/11/2019 10/11/2019 40,000

SO 5/24/2019 10/11/2019 1/15/2020 94,500

AGA 5/24/2019 10/11/2019 3/16/2020 5,000

AGA 4/20/2020 4/20/2020 4/29/2020 20,000

AGA 4/20/2020 11/24/2020 11/24/2020 475,000

SO 4/20/2020 11/24/2020 11/24/2020 1,216,200

AGA 4/20/2020 3/23/2021 3/23/2021 24,900

SO 4/20/2020 3/23/2021 3/23/2021 75,200

AGA 5/19/2021 5/19/2021 5/19/2021 20,000

BSA 5/19/2021 5/19/2021 6/3/2021 39,185

AGA 5/19/2021 11/22/2021 11/22/2021 257,300

SO 5/19/2021 11/22/2021 11/22/2021 1,107,300

AGA 5/19/2021 5/12/2022 5/12/2022 3,200

SO 5/19/2021 5/12/2022 5/12/2022 19,000

AGA 5/12/2022 7/29/2022 7/29/2022 66,700

SO 5/12/2022 7/29/2022 7/29/2022 135,500

AGA 5/12/2022 11/21/2022 11/21/2022 519,650

SO 5/12/2022 11/21/2022 11/21/2022 1,771,786

AGA 4/12/2023 1/9/2023 1/9/2023 35,800

SO 4/12/2023 1/9/2023 1/9/2023 59,200

AGA 4/12/2023 11/20/2023 11/20/2023 912,650

SO 4/12/2023 11/20/2023 11/20/2023 2,290,722

AGA 4/12/2023 1/16/2024 1/16/2024 59,000

SO 4/12/2023 1/16/2024 1/16/2024 262,000

AGA 5/16/2024 5/16/2024 5/16/2024 65,000

SO 5/16/2024 5/16/2024 5/16/2024 272,000

AGA 5/16/2024 11/21/2024 11/21/2024 1,181,700

SO 5/16/2024 11/21/2024 11/21/2024 2,267,300

SO 5/16/2024 12/4/2024 12/4/2024 813,200

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

12.1 Non-employee

12.1 Non-employee warrants

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

3 unchanged sentences

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.

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:

6 unchanged sentences

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

exercise price

intrinsic value

(in thousands

Number of warrants outstanding Weighted- average exercise price (in Euros) Weighted- average remaining contractual term (in years) Aggregate intrinsic value (in thousands of Euros)

Balance as of December 31, 2022 251,693 48.29 4.35 —

1 unchanged sentence

Forfeited during the period — — — —

Exercised during the period

Exercised/released during the period — — — —

Expired during the period ( 7,000 ) — — —

2 unchanged sentences

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

exercise price

intrinsic value

(in thousands

Number of warrants outstanding Weighted- average exercise price (in Euros) Weighted- average remaining contractual term (in years) Aggregate intrinsic value (in thousands of Euros)

Balance as of December 31, 2023 244,693 49.43 3.47 —

1 unchanged sentence

Forfeited during the period — — — —

Exercised during the period

Exercised/released during the period — — — —

Expired during the period — — —

5 unchanged sentences

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 €

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

All SO issued have a ten-year contractual life.

SO are expensed in accordance with the following vesting conditions:

Before June 22, 2018 and from January 15, 2020 to November 22, 2021, 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),

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

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

– service condition:

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

– performance condition:

approval of Viaskin ™

Peanut by the US Food and Drug Administration,

approval of Viaskin™ Peanut by the US Food and Drug Administration.

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

4 unchanged sentences

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

exercise price in

contractual term

Number of SO outstanding Weighted- average exercise price (in Euros) Weighted- average remaining contractual term (in years) Aggregate intrinsic value (in thousands of Euros)

Balance as of December 31, 2022 5,306,569 11.00 8.41 —

Granted during the period 1,926,286 2.03 — —

Forfeited during the period

Exercised during the period

Expired during the period ( 103,314 ) — — —

2 unchanged sentences

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

exercise price in

contractual term

intrinsic value

Number of SO outstanding Weighted- average exercise price (in Euros) Weighted- average remaining contractual term (in years) Aggregate intrinsic value (in thousands of Euros)

Balance as of December 31, 2023 7,129,541 8.49 8.18 —

5 unchanged sentences

Options exercisable as of December 31, 2024 2,065,595 21.02 4.40 —

As of December 31, 2023, there was € 17.8 millions

millions converted at closing rate) of unrecognized SO expense that is expected to be recognized over a weighted-average period of

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

Fair value of stock options

26 unchanged sentences

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

The release of RSUs for

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

FDA for Viaskin ™

Peanut, approval of Viaskin ™

Peanut by the U.S.

FDA, first sale of Viaskin ™

Peanut in the United States);

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

Peanut by the U.S.

Between November 24, 2020 and November 20, 2023, 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).

Since November 20, 2023, RSUs vest over four years at a rate of 25 % upon the first anniversary of the issuance date and 25 % every126 months thereafter, subject to the beneficiary being still employed by the Company (except in specific board of directors’ decisions).

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

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

FDA, first sale of Viaskin™ Peanut in the United States).

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

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

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

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

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

average grant

Number of RSU outstanding Weighted- average grant date fair value in Euros

Balance as of December 31, 2022 .

1,589,081 14.69

Granted during the period .

3 unchanged sentences

Balance as of December 31, 2023 .

2,021,370 11.03

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

average grant

Number of RSU outstanding Weighted- average grant date fair value in Euros

Balance as of December 31, 2023 .

2,021,370 11.03

Granted during the period .

1,305,700 0.60

Forfeited during the period ( 174,278 ) 2.29

2 unchanged sentences

Balance as of December 31, 2024 .

As of December 31, 2023, there was

millions converted at closing rate) of unrecognized RSUs compensation expense that is expected to be recognized over a weighted-average period of

2,813,366 7.67

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

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

Research and development

Sales and marketing

General and administrative

Total share-based compensation (expense) income

Research & development SO ( 1,431 ) ( 1,661 )

RSU ( 913 ) ( 835 )

Sales & marketing SO ( 80 ) ( 102 )

RSU ( 35 ) ( 33 )

General & administrative SO ( 1,794 ) ( 2,985 )

RSU ( 367 ) ( 403 )

Total share-based compensation (expense) ( 4,620 ) ( 6,019 )

Note 13 Contingencies

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The table below shows movements in contingencies:

Collaboration

agreement—Loss

at completion

contingencies

Pension retirement obligations Collaboration agreement - Loss at completion Other contingencies Total

At January 1, 2023

790 19,835 — 20,625

Increases in liabilities 76 — 3,874 3,950

Used liabilities

Reversals of unused liabilities — ( 20,108 ) — ( 20,108 )

Net interest related to employee benefits, an unwinding of discount

Actuarial gains and losses on defined-benefit plans 38 — — 38

1 unchanged sentence

At December 31, 2023

935 — 3,958 4,894

Of which current — — 3,958 3,958

1 unchanged sentence

At January 1, 2024

935 — 3,958 4,894

Increases in liabilities 88 — 125 212

Used liabilities — — ( 3,877 ) ( 3,877 )

Reversals of unused liabilities

Net interest related to employee benefits, and unwinding of discount

Actuarial gains and losses on defined-benefit plans ( 163 ) — — ( 163 )

1 unchanged sentence

At December 31, 2024

838 — 122 960

Of which current — — 122 122

1 unchanged sentence

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

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

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

On October 30, 2023, the Company signed a Mutual Termination Letter Agreement with NESTEC.

Consequently as of December 31 ,

2023, we recorded the following :

Loss on completion accrual reversal of $ 19,9 millions ;

Accrual for ongoing Clinical study completion of $ 2.3 millions.

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

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

• Loss on completion accrual reversal of $ 19.9 million;

• Accrual for ongoing Clinical study completion of $ 2.3 million as of December 31, 2023.

This updated accrual of $ 22 thousand represents our best estimate of the remaining expenses related to the ongoing clinical study which will be incurred after December 31, 2024 and until the end of the study.

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

4 unchanged sentences

Estimated retirement age 67 67

Collective agreement

National Collective Agreement of

Life table TGH05-TGF05

Collective agreement National Collective Agreement of

the pharmaceutical industry

3 unchanged sentences

Other operating income 5 6,962

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

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

The Company is eligible to receive up to €

millions ($ 105.0 millions at December 31

, 2023 closing exchange rate)

in potential development, clinical, regulatory and commercial milestones, inclusive of a non-refundable

upfront payment of €

million that the Company received in July 2016.

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

pandemic, among other factors.

The Company has experienced difficulties in enrolling new patients in this Phase 2 clinical trial notwithstanding the implementation of a protocol amendment

and various other strategies to improve recruitment.

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

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

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 2 clinical trial has been updated accordingly.

On October 30, 2023, the Company signed a Mutual Termination Letter Agreement with NESTEC.

Consequently as of December 31 ,

2023, we recorded

a deferred revenue accrual reversal of $

6.9 millions ;

As of December

2023 , the Company recorded complementary research tax credit for $

millions after having made a complementary statement for 2020, 2021 and 2022.

Total 4,151 15,728

Until the end of 2023, our operating income was composed of both the French Research tax credit (Crédit d’Impôt Recherche, or “CIR”) and the revenue recognized under the Collaboration Agreement with NESTEC.

Following the termination of the Collaboration Agreement on October 30, 2023, we recorded a deferred revenue accrual reversal of $ 7.0 million and our operating income is now exclusively generated by the French research tax credit.

The decrease in Research tax credit was primarily due to:

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

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

Note 15 Operating expenses and Allocation of Personnel Expenses

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

(Dollar amounts presented in thousands)

2024 2023 $ change % of change

Research and Development expenses

External clinical-related expenses 62,448 49,044 13,404 27 %

Employee-related costs excl.

share-based payment expenses

Employee-related costs 17,213 14,401 2,812 20 %

Share-based payment expenses 2,343 2,496 ( 153 ) ( 6 ) %

Depreciation and amortization ( 719 ) ( 13,658 ) 12,939 ( 95 ) %

Other costs 8,058 7,940 118 1 %

Total Research and Development expenses 89,342 60,223 29,120 48 %

Our research and development expenses consisted primarily of external costs, such as startup fees paid to investigators, consultants, central laboratories and CROs in connection with our clinical trials, and costs related to acquiring and manufacturing clinical study materials.

Research and Development expenses decreased by $ 15.3 millions for the year ended December 31, 2023 compared to the year ended December 31, 2022 mainly as a result of :

loss on completion accrual net reversal $ 17,6 millions (compared to a $ 10.4 millions depreciation as of December 31, 2022) resulting from Nestlé Collaboration Agreement termination, that offset;

the global increase of $ 11.3 million in research and development expenses.

External clinical-related expenses increased by $ 6.8 millions for the year ended December 31, 2023 compared to the year ended December 31, 2022, reflecting intensified Research and Development activities (1) after the initiation of the VITESSE trial with the first patient screened in March 2023, and (2) as part of the new safety study for toddlers and children after the FDA confirmed additional safety data is required for BLA.

Employee-related costs, excluding share-based payment expenses, increased by $ 3.6 million for the year ended December 31, 2023 compared to the year ended December 31, 2022 due to the workforce increase to support research and development activities on VITESSE trial and the new safety study for toddlers and children.

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

Employee-related costs, excluding share-based payments, increased by $ 2.8 million for the year ended December 31, 2024 compared to the year ended December 31, 2023 due to the recruitment of 12 FTE in Medical, Quality and Regulatory Affairs, mostly based in the U.S.

Depreciation, amortization and other costs increased by $ 12.9 million for the year ended December 31, 2024 compared to the year ended December 31, 2023, due to (1) the termination of the Collaboration Agreement with NESTEC that explained the accrual net reversal in 2023, (2) accruals reversal on CRO activities and (3) Medical, Quality and Regulatory Affairs activities.

Sales and Marketing Expenses

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

(Dollar amounts presented in thousands)

Sales and marketing expenses

2024 2023 $ change % of change

Sales & Marketing expenses

External professional services and other costs 1,770 1,684 86 5 %

Employee-related costs incl.

share-based payment expenses 890 754 136 18 %

External professional services and other costs

Total Sales and marketing expenses

Sales and marketing expenses primarily included payroll for the U.S.

and European employees as well as fees related to pre- commercialization activities for Viaskin Peanut in North America.

Sales and Marketing expenses increased by $ 0.8 million for the year ended December 31, 2023 compared to the year ended December 31, 2022, primarily due to an increase in fees related to pre-commercialization activities for Viaskin Peanut in North America.

Employee-related costs (including share-based payments expenses) related to payroll for the U.S.

and European employees, decreased by $ 0.2 million for the year ended December 31, 2023 compared to the year ended December 31, 2022, due to employee departure in the US.

External professional services and other costs increased by $ 1.0 million for the year ended December 31, 2023 compared to the year ended December 31, 2022, mainly due to an increase in fees related to pre-commercialization activities for Viaskin Peanut in North America.

Total Sales & Marketing expenses 2,659 2,438 222 9 %

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

General and Administrative Expenses

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

(Dollar amounts presented in thousands)

General and administrative expenses

External professional services fees

Employee-related costs excl.

share-based payment expenses

2024 2023 $ change % of change

General & Administrative expenses

External professional services 10,052 8,750 1,302 15 %

Employee-related costs 8,981 8,201 780 10 %

Share-based payment expenses 2,161 3,388 ( 1,227 ) ( 36 ) %

Depreciation, amortization and other costs 7,545 9,161 ( 1,617 ) ( 18 ) %

Total General and administrative expenses

General and administrative expenses increased by $ 5.2 millions for the year ended December 31, 2023, compared to the year ended December 31, 2022.

The source of this increase is threefold (1) an increase by $ 2.8 millions of external professional services fees incurred in our financing activities, (2) an increase by $ 0.9 million in employee-related costs to support General and Administrative activities, and (3) an increase by $ 0.8 million in depreciation, amortization and other costs mainly due to Montrouge office revamping which will be departed for a new location in Q2 of 2024.

The workforce dedicated to general and administrative activities increased from 27 employees in 2022 to 34 employees in 2023.

Allocation of Personnel Expenses

The Company had 104 average employees for the year ended December 31, 2023, in comparison with 101 employees for the year ended December 31, 2022.

Total General & Administrative expenses 28,739 29,500 ( 762 ) ( 3 ) %

General and administrative expenses decreased by $ 0.8 million for the year ended December 31, 2024, compared to the year ended December 31, 2023.

External professional services increased by $ 1.3 million for the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due to one-time costs associated with (1) office moves in France and the U.S, (2) financing activities and (3) trademark and patent activities.

This increase is offset by a decrease in Depreciation, amortization and other costs by $ 1.6 million for the year ended December 31, 2024, compared to the year ended December 31, 2023 primarily due to the provision reversal on the Montrouge office revamping.

Allocation of Personnel Expenses by Function:

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

Research and development expenses 19,557 16,897

1 unchanged sentence

General and administrative expenses 11,142 11,589

Total personnel expenses

Total personnel expenses including SBP costs 31,588 29,240

Allocation of Personnel Expenses by Nature:

3 unchanged sentences

Share-based payments 4,620 6,019

The increase in personnel expenses is mainly due to an increase in headcount to support research and development activities (1) after the initiation of the VITESSE trial with the first patient screened in March 2023, and (2) as part of the new safety study for toddlers after the FDA confirmed additional safety data is required for BLA.

Total 31,588 29,240

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

Note 16 Income Tax

10 unchanged sentences

Other differences ( 14 ) 386

Effective tax expenses—current

Effective tax expenses—deferred

Effective tax expenses ( 55 ) ( 7 )

Effective tax rate 0.05 % 0.01 %

7 unchanged sentences

Pension retirement obligations 209 509

Leases 100 32

Other 403 1,205

Total deferred tax assets 325,150 309,977

3 unchanged sentences

Purchase Obligations

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

Peanuts and Viaskin ™

Milk products.

As of December 31, 2023, expenses associated with the ongoing trials amounted globally to

$ 114.4 millions, and we had non-cancellable

contractual obligations with CRO until year ended 2025 amounting to

$ 64.4 millions.

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

As of December 31, 2024, expenses associated with the ongoing trials amounted globally to $ 170.3 million, and we had non-cancellable contractual obligations with CRO until year ended 2026 amounting to $ 10.0 million.

Letter of Credit and Collateral

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

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

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

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

Note 18 Relationships with Related Parties

The compensation amounts for 2023 presented below, which were awarded to the Directors and Officers of the Company totaled

$ 8.7 millions.

The compensation amounts for 2024 presented below, which were awarded to the Directors and Officers of the Company totaled $ 8.5 million.

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

3 unchanged sentences

Share-based payments 2,642 3,792

Total 8,512 8,685

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

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

Compensation 1,532 2,112

Pension obligations 127 107

Total 1,659 2,219

Note 19 Loss Per Share

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.

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

As the Company was in a loss position for the years ended December 31, 2024 and 2023, the diluted loss per share is equal to basic loss per share because the effects of potentially dilutive shares were anti-dilutive given the Company’s net loss.

1 unchanged sentence

Dollars except share and per share data):

Net loss ( 113,918 ) ( 72,726 )

Weighted average number of ordinary shares 96,995,379 95,121,390

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

Net loss per share attributable to ordinary shareholders, basic and diluted ($/share) ( 1.17 ) ( 0.76 )

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:

5 unchanged sentences

Note 20 Events after the Close of the Fiscal Year

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

On March 27, 2025, the company announced a financing of up to $ 306.9 million (€ 284.5 million), to Advance Viaskin® Peanut Patch Through Biologics License Application Submission and U.S.

Commercial Launch, if Approved.

The financing includes gross proceeds of $ 125.5 million (€ 116.3 million) received on April 7 2025 and up to $ 181.4 million (€ 168.2 million) in potential additional gross proceeds that may be received if all the warrants are exercised, subject to satisfaction of specified conditions.

The VITESSE Phase 3 study hitting its primary endpoint will trigger an acceleration of the exercise period of some of the warrants.

The ABSA Warrants will be exercisable from their respective date of issue until the earlier of (i) April 7, 2027 and (ii) 30 days following the publication by the Company of a press release announcing that the ongoing VITESSE trial of Viaskin peanut in 4-7 years old met the primary endpoint defined in the VITESSE study protocol, it being specified that (i) the primary measure of treatment effect will be the difference in response rates at Month 12 between active and placebo treatment groups, (ii) the primary analysis will be based on a 2-sided confidence interval ("CI") for the difference in response rates and (iii) the primary analysis must be positive according to the success criterion (lower bound of the 2-sided 95 % CI of the difference in response rates ≥ 15 %) (the "ABSA Warrant Exercise Period").

The exercise of one (1) ABSA Warrant will give the right to subscribe to one point seventy-five ( 1.75 ) ABSA Warrant Shares at a price of € 1.5939 per ABSA Warrant

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

The financing consists of:

• a share capital increase without preferential subscription rights reserved to categories of persons satisfying determined characteristics pursuant to the 24th resolution of the general meeting of shareholders of May 16, 2024 (the "2024 General Meeting") completed on April 7, 2025 for an amount of € 38 million, consisting of the issuance of (i) 34,090,004 new shares at a par value of € 0.10 (the "New Shares") each with warrants of the Company attached (the "ABSA Warrants", and together with the New Shares, the "ABSA") at a subscription price of € 1.1136 per ABSA and (ii) up to 59,657,507 additional new shares, if all the ABSA Warrants attached to the New Shares are exercised (the "ABSA Warrant Shares");

• the issue through an offering reserved to categories of persons satisfying determined characteristics of 71,005,656 units (the “PFW-BS-PFW”) completed on April 7, 2025 for an amount of € 79 million at a subscription price of € 1.1136 per PFW-BS-PFW (of which € 1.1036 will have been prefunded on the issue date), each PFW-BS-PFW consisting of one pre-funded warrant to subscribe for one share of the Company (the "First Pre-Funded Warrants") and one warrant (the "BS Warrants") to subscribe to one second pre-funded warrants (the "Second Pre-Funded Warrants"), each of which entitles the holder to subscribe for 1.75 shares of the Company (the "Second PFW Shares"), allowing to issue up to 71,005,656 additional new shares if all the First Pre-Funded Warrants are exercised (the "First PFW Shares") and up to 124,259,898 additional new shares if all the Second Pre-Funded Warrants are exercised (the "Second PFW Shares", together with the ABSA Warrant Shares and the First Pre-Funded Warrant Shares, the "Warrant Shares", and together with the New Shares, the "Offered Shares"),

(together, the "Offering").

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

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

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

Note 21 Reportable Segment Disclosure

Viaskin Peanut Segment December 31,

Clinical studies 41,748 25,059

BLA & Regulatory 7,871 3,501

Medical Affairs & Other Medical 7,316 6,270

Research & Innovation 2,011 2,058

Manufacturing & Supply and Quality 30,396 23,335

Sales & Marketing 2,660 2,438

General & Administrative 28,738 29,500

Total expenses 120,740 92,161

The Company operates and is managed as one operating segment driving expenses for the development of Viaskin Peanut.

The Company’s R&D organization is primarily responsible for the development and registration efforts of Viaskin Peanut.

The Company’s technical operations group is responsible for the development of manufacturing processes, supplying clinical drug product.

The Company is also supported by corporate staff functions.

The Company’s Chief Executive Officer as the CODM manages and allocates resources to the operations of the total company by assessing the overall level of resources available and how to best allocate them to support the Company’s long-term company-wide strategic goals.

In making this decision, the CODM uses consolidated financial information for the purposes of evaluating performance, allocating resources, setting incentive compensation targets and planning and forecasting for future periods.

The CODM's analysis includes a comparison to budgeted results.

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

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