DBV Technologies S.A. 10-K

Item 9A. Controls and Procedures. Evaluation of Disclosure Controls and Procedures. We maintain “disclosure controls and procedures,” as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the rules and forms of the Securities and Exchange Commission. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act is accumulated and communicated to management, including our chief executive officer (principal executive officer) and chief financial officer (principal financial officer), as appropriate, to allow timely decisions regarding required disclosure. Our principal executive officer and principal financial officer evaluated the effectiveness of these disclosure controls and procedures and concluded that as of December 31, 2023, our disclosure controls and procedures were effective. Management’s Report on Internal Control Over Financial Reporting. Our management is responsible for establishing and maintaining adequate internal controls over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) and for the assessment of the 116 effectiveness of our internal control over financial reporting. Under the supervision and with the participation of our chief executive officer (principal executive officer) and chief financial officer (principal financial officer), management assessed the effectiveness of our internal control over financial reporting based upon the framework in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements and can only provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. A deficiency in internal control over financial reporting exists when the design or operation of a control does not allow management or employees, in the normal course of performing their assigned functions, to prevent or detect misstatements on a timely basis. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the registrant’s annual or interim financial statements will not be prevented or detected on a timely basis. Based on this assessment, our management has concluded that our internal control over financial reporting was effective as of December 31, 2023. As a smaller reporting company, our independent registered accounting firm is not required to issue an attestation report on our internal control over financial reporting. Changes in Internal Control over Financial Reporting. 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, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. Item 9B. Other Information. During the fiscal quarter ended December 31, 2023, no ne 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. Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. Not applicable. PART III 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. Item 10. 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. 117 Item 11. 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. Item 12. 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. Item 13. 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. Item 14. 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. PART IV Item 15. Exhibits and Financial Statement Schedules. The financial statements schedules and exhibits filed as part of this Annual Report on Form 10-K are as follows: (a)(1) Financial Statements Reference is made to the financial statements included in Item 8 of Part II hereof. (a)(2) Financial Statement Schedules All other schedules are omitted because they are not required or the required information is included in the financial statements or notes thereto. (a)(3) Exhibits 118 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 10/15/14   4.2 Form of American Depositary Receipt Form F-1/A 333-198870 4.1 10/15/14   4.3 Description of Registered Securities Form 20-F 001-36697 2.3 03/20/20   4.4 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 03/23/18   4.5 Registration Rights Agreement, dated as of June 8, 2022, between the registrant and the Investors named therein. Form 8-K 001-36697 10.2 06/13/22   4.6 Securities Purchase Agreement, dated as of June 8, 2022, between the registrant and the Subscribers named therein. Form 8-K 001-36697 10.1 06/13/22  10.1 Office Lease between the registrant and GENERALI VIE, dated March 3, 2025 (English translation) Form 20-F 001-36697 4.2 04/29/15  10.2* Office Lease between the registrant and SCI DANTON MALAKOFF, dated October 2, 2023 (English translation)  10.3* Lease Agreement between DBV Technologies Inc. and SIG 106 LLC, dated March 28, 2022  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 09/22/14  10.5# Development Collaboration and License Agreement between the registrant and NESTEC S.A., dated May 27, 2016 Form 20-F 001-36697 4.14 03/22/17  10.6# Amendment to Development Collaboration and License Agreement between the registrant and NESTEC S.A., dated July 12, 208 Form 20-F 001-36697 4.5 04/01/19  10.7* 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  10.8† Form of Indemnification Agreement between the registrant and each of its executive officers and directors Form F-1/A 333-198870 10.3 10/15/14  10.9† 2013 and 2014 Share Option Plans (English translation) Form F-1/A 333-198870 10.4 09/22/14 119 Incorporated by Reference Exhibit Description Schedule/ Form File Number Exhibit File Date  10.10† 2012, 2013 and 2014 Free Share Plans (English translation) Form F-1/A 333-198870 10.5 09/22/14  10.11† Summary of BSA Form F-1 333-198870 10.6 09/22/14  10.12† Summary of BSPCE Form F-1 333-198870 10.7 09/22/14  10.13† 2015 Share Option Plan (English translation) Form 20-F 001-36697 4.10 04/28/16  10.14† 2015 Free Share Plans (English translation) Form 20-F 001-36697 4.11 04/28/16  10.15† 2016 Share Option Plan (English translation) Form 20-F 001-36697 4.12 03/22/17  10.16† 2016 Free Share Plan (English translation) Form 20-F 001-36697 4.13 03/22/17  10.17† 2017 Share Option Plan (English translation) Form 20-F 001-36697 4.14 03/16/18  10.18† 2017 Free Share Plan (English translation) Form 20-F 001-36697 4.15 03/16/18  10.19† 2018 Share Option Plan (English translation) Form 20-F 001-36697 4.17 04/01/19  10.20† 2018 Free Share Plan (English translation) Form 20-F 001-36697 4.18 04/01/19  10.21† 2019 Share Option Plan (English translation) Form 20-F 001-36697 4.19 03/20/20  10.22† 2019 Free Share Plan (English translation) Form 20-F 001-36697 4.20 03/20/20  10.23† 2020 Share Option Plan (English translation) Form 10-K 001-36697 10.21 03/17/21  10.24† 2020 Free Share Plan (English translation) Form 10-K 001-36697 10.22 03/17/21  10.25† 2021 Share Option Plan (English translation) Form 10-K 001-36697 10.22 03/9/22  10.26† 2021 Free Share Plan (English translation) Form 10-K 001-36697 10.23 03/9/22  10.27† 2022 Share Option Plan (English translation) Form 10-K 001-36697 10.24 03/2/23  10.28† 2022 Free Share Plan (English translation) Form 10-K 001-36697 10.25 03/2/23  10.29† 2023 Share Option Plan (English translation) S-8 333-275662 99.3 11/20/23  10.30† 2023 Free Share Plan (English translation) S-8 333-275662 99.2 11/20/23  10.31† Executive Agreement, dated November 29, 2018, between the registration and Daniel Tassé Form 10-K 001-36697 10.23 03/17/21  10.32† 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 03/17/21  10.33† Executive Agreement, dated July 22, 2019, between the registrant and Pharis Mohideen Form 10-K 001-36697 10.25 03/17/21  10.34† Letter Agreement, dated June 26, 2019, between the registrant and Sébastien Robitaille (English translation) Form 10-K 001-36697 10.26 03/17/21  10.35† Letter Agreement, dated December 1, 2020, between the registrant and Sébastien Robitaille (English translation) Form 10-K 001-36697 10.27 03/17/21 120 Incorporated by Reference Exhibit Description Schedule/ Form File Number Exhibit File Date  10.36*† English Summary Translation of Separation Agreement and Release between Sébastien Robitaille and registrant  10.37*† Letter Agreement, dated November 1, 2023, between the registrant and Virginie Boucinha (English translation)  21.1*† List of subsidiaries of the registrant  23.1* Consent of Deloitte & Associés  23.2* Consent of KPMG S.A.  24.1** Power of Attorney (included on the signature page of this report).  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  31.2 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  32.1** Certification by the Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002  97.1* Incentive Compensation Recoupment Policy, approved 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) * Filed herewith. ** Furnished herewith and not deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and shall not be deemed to be incorporated by reference into any filing under the Securities Act .of 1933, as amended, or the Exchange Act (whether made before or after the date of the Form 10-K), irrespective of any general incorporation language contained in such filing. † Indicates a management contract or any compensatory plan, contract or arrangement. # Confidential treatment has been granted from the Securities and Exchange Commission as to certain portions of this document 121 SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. DBV Technologies S.A. /s/ Daniel Tassé Name: Daniel Tassé Title: Chief Executive Officer (Principal Executive Officer) Date: March 7, 2024 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 Daniel Tassé Chief Executive Officer and Director ( Principal Executive Officer ) /s/ Virginie Boucinha Virginie Boucinha Chief Financial Officer ( Principal Financial and Accounting Officer ) /s/ Michel de Rosen Michel de Rosen Director /s/ Mailys Ferrere Mailys Ferrere Director /s/ Michael J. Goller Michael J. Goller Director /s/ Danièle Guyot-Caparros Danièle Guyot-Caparros Director /s/ Timothy E. Morris Timothy E. Morris Director 122 Signature Title /s/ Ador Ndu Adora Ndu Director /s/ Julie O’Neill Julie O’Neill Director /s/ Ravi Madduri Rao Ravi Madduri Rao Director /s/ Daniel Soland Daniel Soland Director 123 Index to Financial Statements Annual Financial Statements for the Years Ended December 31, 2023 and 2022: Page Report of Deloitte & Associés and KPMG S.A., Independent Registered Public Accounting Firms (Deloitte & Associés, Paris-La Défense, France, PCAOB ID No. 1756 ) (KPMG S.A., Paris-La Défense, France, PCAOB ID No. 1253 ) F-2 Consolidated Statements of Financial Position as of December 31, 2023 and 2022 F- 4 Consolidated Statements of Operations and Comprehensive Loss for the Years Ended December 31, 2023 and 2022 F- 5 Consolidated Statements of Cash Flows for the Years Ended December 31, 2023 and 2022 F- 6 Consolidated Statements of Changes in Shareholders’ Equity for the Years Ended December 31, 2023 and 2022 F- 7 Notes to the Consolidated Financial Statements F- 8 F-1 Table of Contents REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMS To the Shareholders and Board of Directors of DBV Technologies S.A. Opinion on the Consolidated Financial Statements 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. Basis for Opinion These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are public accounting firms registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion. Critical Audit Matter The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee F-2 Table of Contents and that: (1) relates to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates. Going Concern – Refer to Note 1 to the consolidated financial statements Critical Audit Matter Description As described further in Note 1 to the consolidated financial statements, the Company has incurred operating losses and negative cash flows from operations since inception. The Company does not generate product revenue and continues to prepare for the potential launch of its first product in the United States and in the European Union, if approved. The Company cannot guarantee that it will be able to obtain the necessary financing to meet its needs or to obtain funds at attractive terms and conditions. The Company’s available cash and cash equivalents are not sufficient to support its operating plan for at least the next twelve months from the issuance date of these consolidated financial statements. As such, substantial doubt exists regarding the Company’s ability to continue as a going concern. We identified the evaluation of the Company’s ability to continue as a going concern and related disclosures as a critical audit matter. This matter required a high degree of auditor judgment and increased effort when performing audit procedures to evaluate (1) the reasonableness of management’s forecasted operating expenses, and (2) the adequacy of the consolidated financial statements disclosure related to the going concern assessment. How the Critical Audit Matter was Addressed in the Audit The primary audit procedures we performed to address this critical audit matter included the following: • We 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 KPMG S.A. /s/ Cédric Adens Partner We have served as the Company’s auditor since 2011. We have served as the Company’s auditor since 2020. Paris-La Défense, France March 7, 2024 F- 3 Table of Contents DBV Technologies S.A. Consolidated Statements of Financial Position (amounts in thousands, except share and per share data) Year ended December 31, Note 2023 2022 Assets Current assets: Cash and cash equivalents 3 $ 141,367 $ 209,194 Trade receivables —   —   Other current assets 4 17,548 13,880 Total current assets 158,915 223,074 Property, plant, and equipment, net 5 12,623 15,096 Right-of-use assets related to operating leases 6 5,247 2,513 Intangible assets 58 10 Other non-current assets 7 6,144 5,824 Total non-current assets 24,071 23,444 Total Assets $ 182,986 $ 246,518 Liabilities and shareholders’ equity Current liabilities Trade payables 8 $ 23,302 $ 14,473 Short-term operating leases 6 1,144 1,894 Short-term financial debt 9 —   —   Current contingencies 13 3,959 3,944 Other current liabilities 8/9 8,934 9,210 Total current liabilities 37,339 29,521 Long-term operating leases 6 4,526 1,127 Long-term financial debt —   —   Non-current contingencies 13 935 16,680 Other non-current liabilities 9 —   4,735 Total non-current liabilities 5,461 22,543 Total liabilities $ 42,799 $ 52,064 Shareholders’ equity: 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 $ 10,972 $ 10,720 Additional paid-in capital 377,468 458,221 Treasury stock, 222,988 and 149,793 ordinary shares as of December 31, 2023 and 2022, respectively, at cost ( 1,263 ) ( 1,109 ) Accumulated deficit ( 238,862 ) ( 259,578 ) Accumulated other comprehensive income 742 781 Accumulated currency translation effect ( 8,871 ) ( 14,581 ) Total shareholders’ equity 11 $ 140,187 $ 194,453 Total liabilities and shareholders’ equity $ 182,986 $ 246,518 The accompanying notes are an integral part of these consolidated financial statements F- 4 Table of Contents DBV Technologies S.A. Consolidated Statements of Operations and Comprehensive Loss (amounts in thousands, except share and per share data) Year ended December 31, Note 2023 2022 Operating income 14 $ 15,728 $ 4,844 Operating expenses Research and development expenses 15 ( 60,223 ) ( 75,543 ) Sales & marketing expenses 15 ( 2,438 ) ( 1,608 ) General & administrative expenses 15 ( 29,500 ) ( 24,324 ) Total Operating expenses ( 92,161 ) ( 101,475 ) Loss from operations ( 76,432 ) ( 96,631 ) Financial income (expenses) 3,714 427 Loss before taxes ( 72,719 ) ( 96,204 ) Income tax 16 ( 7 ) ( 70 ) Net loss $ ( 72,726 ) $ ( 96,274 ) Foreign currency translation differences, net of taxes 5,710 ( 8,429 ) Actuarial gains on employee benefits, net of taxes ( 38 ) 262 Total comprehensive loss $ ( 67,054 ) $ ( 104,441 ) Basic/diluted Net loss per share attributable to shareholders 19 $ ( 0.76 ) $ ( 1.24 ) Weighted average number of shares outstanding used in computing per share amounts: 19 95,121,390 77,384,133 The accompanying notes are an integral part of these consolidated financial statements F- 5 Table of Contents DBV Technologies S.A. Consolidated Statements of Cash Flows (amounts in thousands) Year ended December 31, Notes 2023 2022 Net loss for the period $ ( 72,726 ) $ ( 96,274 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation, amortization and accrued contingencies ( 13,998 ) 13,162 Retirement pension obligations 76 105 Expenses related to share-based payments 6,019 5,026 Other elements 23 ( 7 ) 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 ( 3,795 ) 20,961 (Decrease) increase in trade payables 8,420 3,456 (Decrease) increase in other current and non-current liabilities ( 5,334 ) 152 Change in operating lease liabilities and right of use assets 1,662 ( 2,249 ) Net cash flow used in operating activities ( 79,653 ) ( 55,666 ) Cash flows used in investing activities: Acquisitions of property, plant, and equipment ( 677 ) ( 754 ) Proceeds from property, plant, and equipment dispositions —   8 Acquisitions of intangible assets —   —   Acquisitions of non-current financial assets ( 285 ) ( 123 ) Proceeds from non-current financial assets dispositions 154 770 Net cash flows used in investing activities ( 808 ) ( 100 ) Cash flows provided by financing activities: (Decrease) increase in conditional advances —   ( 474 ) Treasury shares ( 154 ) 123 Capital increases, net of transaction costs 6,921 194,471 Other cash flows related to financing activities —   —   Net cash flows provided by financing activities 6,767 194,120 Effect of exchange rate changes on cash and cash equivalents 5,867 ( 6,461 ) Net (decrease) / increase in cash and cash equivalents ( 67,827 ) 131,893 Net cash and cash equivalents at the beginning of the period 209,194 77,301 Net cash and cash equivalents at the end of the period 3 $ 141,367 $ 209,194 The accompanying notes are an integral part of these consolidated financial statements F- 6 Table of Contents DBV Technologies S.A. Consolidated Statements of Changes in Shareholders’ Equity (amounts in thousands, except share and per share data) Ordinary shares Acc. other comprehensive income Acc. currency translation effect Number of Shares Note 11 Amount Additional paid-in capital Treasury stock Acc. deficit Total Equity Balance at December 31, 2021 55,095,762 $ 6,538 $ 358,115 $ ( 1,232 ) $ ( 258,528 ) $ 519 $ ( 6,137 ) $ 99,274 Net (loss) ( 96,274 ) ( 96,274 ) Other comprehensive (loss) 262 ( 8,429 ) ( 8,167 ) Issuance of ordinary shares 39,041,383 4,182 102,194 106,377 Issuance of share warrants —  —  88,094 —  —  —  —  88,074 Treasury shares 123 123 Share-based payments (income) expenses 5,026 5,026 Allocation of accumulated net losses —  —  ( 95,209 ) —  95,209 —  —  —  Other change in equity —  —  —  —  15 ( 15 ) —  Balance at December 31, 2022 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 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 The accompanying notes are an integral part of these consolidated financial statements F- 7 Table of Contents Notes to the Consolidated Financial Statements 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 ™ . Basis of Presentation The Company’s consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the U.S. (“U.S. GAAP”) and presented in thousands of U.S. Dollars, except for share and per share data and as otherwise noted. Any reference in these notes to applicable guidance is meant to refer to authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). We also follow the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). The Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern and using the historical cost principle with the exception of certain assets and liabilities that are measured at fair value in accordance with U.S. GAAP. The categories concerned are detailed in the following notes. Principles of Consolidation The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. Intercompany transactions and balances have been eliminated. The following list presents all entities included in the consolidation scope for the years ended December 31, 2022 and 2023, as well as their country of incorporation and the percentage of ownership interests: • DBV Technologies Inc. was incorporated in Delaware on April 7, 2014 (the “US subsidiary”). The share capital of this US subsidiary is 100 % owned by DBV Technologies S.A. • DBV Australia Pty Ltd. was incorporated in New South Wales, Australia on July 3, 2018 (the “Australian subsidiary”). The share capital of this Australian subsidiary is 100 % owned by DBV Technologies S.A. (“DBV Technologies”). • DBV Pharma was incorporated in Paris on December 21, 2018 (the “French subsidiary”). The share capital of this French subsidiary is 100 % owned by DBV Technologies S.A. Functional Currency and Translation of Financial Statements in Foreign Currency The Consolidated Financial Statements are presented in U.S. dollars, which differs from the functional currency of the Company, being the Euro. The statements of financial position of consolidated entities having a functional currency different from the presentation currency are translated at the closing exchange rate (spot exchange rate at the statement of financial position date) and the statements of operations, statements of comprehensive loss and statements of cash flow of such consolidated entities are translated at the weighted average exchange rate. The resulting translation adjustments are included in equity under the caption “Accumulated other comprehensive income (loss)” in the Consolidated Statements of Changes in Shareholders’ Equity. Conversion of Foreign Currency Transactions Foreign currency transactions are converted to functional currency of the entity at the rate of exchange applicable on the transaction date. At period-end, foreign currency monetary assets and liabilities are converted at the rate of F- 8 Table of Contents exchange prevailing on that date. The resulting exchange gains or losses are recorded in the entity individual statements of operations in “Financial income (expense)”; they will be recognized in profit or loss on disposal of the net investment. Use of estimates The preparation of the Company’s consolidated financial statements requires the use of estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, and disclosures of contingent assets and liabilities at the date of the consolidated financial statements and the reported amount of income and expenses during the period. The Company bases its estimates and assumptions on historical experience and other factors that it believes to be reasonable under the circumstances. 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. 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 ™ Peanut. The Company also initiated a global restructuring plan in June 2020 to provide operational latitude to progress the clinical development and regulatory review of Viaskin ™ Peanut in the United States and European Union. 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, F- 9 Table of Contents 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, 2024. 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 financings. 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. The COVID-19 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 F-1 0 Table of Contents arrangements with collaborators or others that may require the Company to relinquish rights to its product candidates that the Company might otherwise seek to develop or commercialize independently. These Consolidated Financial Statements do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses that may be necessary if the Company were unable to continue as a going concern. Intangible Assets Acquired intangible assets are accounted for at acquisition cost less accumulated amortization. Acquired intangible assets are mainly composed of software amortized on a straight-line basis over their estimated useful lives comprised between one and three years . Intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The costs related to the acquisition of licenses to software are posted to assets on the basis of the costs incurred to acquire and to implement the software. Property, Plant, and Equipment Property, plant, and equipment are recorded at their acquisition cost. Property, plant, and equipment are depreciated on a straight-line method over the estimated useful lives of the property. Leasehold improvements are amortized over the shorter of the estimated useful lives of the assets or the remaining lease term. Depreciation is calculated on a straight-line basis over the assets’ estimated useful lives as follows: 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 The Company periodically reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable or the estimated useful life is no longer appropriate. If indicators of impairment exist and the recoverable value of the asset on an undiscounted cash flow basis is less than the carrying amount, an impairment loss is recorded to the extent the carrying amount exceeds its fair value. Lease contracts The Company determines whether an arrangement is a lease at contract inception by establishing if the contract conveys the right to use, or control the use of, identified property, plant, or equipment for a period of time in exchange for consideration. The Company’s leases are comprised of real estate leases, leases for industrial equipment and leases for office equipment. The Company’s real estate leases typically include options and features including rent free periods, rent escalation periods, renewal options and early termination options. The lease term is defined contract-by-contract and corresponds to the non-cancelable period of the lease taking into account the optional periods that are reasonably certain to be exercised. F-1 1 Table of Contents The Company recognizes operating lease liabilities based on the present value of the future minimum lease payments over the lease term at commencement date. The Company does not recognize a lease liability or right of use asset for leases with a term of 12 months or less. Operating lease right of use assets are presented as operating lease right of use assets on the consolidated balance sheet. To date, the Company has recognized a single lease cost under which the operating lease right of use and liability are amortized on a straight-line basis over the lease term, and categorized within Operating Expense in the Consolidated Statement of Operations. The operating lease cash flows are categorized under Net Cash Used in Operating Activities in the Consolidated Statement of Cash Flows. Variable costs are expensed in the period incurred. Since the rate implicit in the lease is not readily determinable, the Company uses its incremental borrowing rates based on the information available at commencement date in determining the discount rate used to calculate the present value of lease payments. As the Company has no external borrowings, the incremental borrowing rates are determined using information on indicative borrowing rates that would be available to the Company based on the value, currency and borrowing term provided by financial institutions, adjusted for company and market specific factors. Inventories and Work in Progress Inventories are measured at the lower of cost or net realizable value at production costs calculated using the first-in, first-out method. It includes acquisition costs, processing costs and other costs incurred in bringing the inventories to their present location and condition. Inventories are exclusively composed of work in progress relating to the production of the first batches that may be used for the commercialization. During the launch phase of a new product, any inventories of that product are written down to zero pending regulatory approval. Financial Assets and Liabilities Financial assets, excluding cash and cash equivalents, consist exclusively of other receivables. Other receivables are non-derivative financial assets with a payment, which is fixed or can be determined, not listed on an active market. They are included in current assets, except those that mature more than twelve months after the reporting date. The recoverable amount of other receivables is estimated whenever there is an indication that the asset may be impaired and at least on each reporting date. If the recoverable amount is lower than the carrying amount, an impairment loss is recognized in the Consolidated Statements of Operations and Comprehensive Loss. The Company also receives from time-to-time assistance in the form of conditional advances, which are advances repayable in whole or in part based upon acknowledgment by the funder of a technical or commercial success of the related project by the funding entity. The amount resulting from the deemed benefit of the interest-free nature of the award is considered a subsidy for accounting purposes. This deemed benefit is determined by applying a discount rate equal to the rate of fungible treasury bonds over the time period that corresponds to the time period of the repayment of the advances. In the event of a change in payment schedule of the stipulated repayments of the conditional advances, the Company makes a new calculation of the net book value of the debt resulting from the discounting of the expected new future cash flows. The adjustment that results therefrom is recognized in the income statement for the fiscal year during which the modification is recognized. F-1 2 Table of Contents The Company carries its trade receivable at net realizable value. On a periodic basis, the Company evaluates its trade receivable and determines whether to provide an allowance or if any accounts should be written down and charged to expense as a bad debt. 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. Fair Value Measurements Fair value is defined as an exit price, representing the amount that would be received upon the sale of an asset or payment to transfer a liability in an orderly transaction between market participants. Fair value is a market-based measurement that is determined based on assumptions that market participants would use in pricing an asset or liability. A three-tier fair value hierarchy is used to prioritize the inputs in measuring fair value as follows: • Level 1—Quoted market prices (unadjusted) in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. • Level 2—Quoted market prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable, either directly or indirectly. Fair value determined through the use of models or other valuation methodologies. • Level 3—Significant unobservable inputs for assets or liabilities that cannot be corroborated by market data. Fair value is determined by the reporting entity’s own assumptions utilizing the best information available and includes situations where there is little market activity for the asset or liability. The asset’s or liability’s fair value measurement within the fair value hierarchy is based upon the lowest level of any input that is significant to the fair value measurement. The Company’s policy is to recognize transfers between levels of the fair value hierarchy in the period the event or change in circumstances that caused the transfer. There were no transfers into or out of Level 1, 2, or 3 during the periods presented. The Company considers its cash and cash equivalents, accounts receivable and accounts payable to reflect their fair value given their short maturity and risk profile of the counterparty. Cash and Cash Equivalents 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. Demand deposits therefore meet the definition of cash equivalents. Cash equivalents are measured at fair value using level 1 and any changes are recognized in the Consolidated Statements of Operations and Comprehensive Loss. Concentration of Credit Risk The Company has no significant off-balance sheet risk, such as foreign currency contracts, options contracts, or other foreign hedging arrangements. Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and other receivables. Periodically, the Company maintains deposits in accredited financial institutions in excess of federally insured limits. The Company deposits its cash in financial institutions that it believes have high credit quality and have not experienced any losses on such accounts and does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships or entities for which it has a receivable. F-1 3 Table of Contents Share Capital Ordinary shares are classified under Shareholders’ Equity. The costs of share capital transactions that are directly attributable to the issue of new shares or options are recorded in the Consolidated Financial Statements in Shareholders’ Equity as a deduction from the proceeds from the issue, net of tax. Employee benefits Depending on the laws and practices of the countries in which the Company operates, employees may be entitled to compensation when they retire or to a pension following their retirement. For state-managed plans and other defined contribution plans, the Company recognizes them as expenses when they become payable, with the Company’s commitment being limited to our contributions. The liability with respect to defined benefit plans is estimated using the following main assumptions: • discount rate; • future salary increases; • employee turnover; and • mortality tables. The difference between the amount of the liability at the beginning of a fiscal year and at the close of that year is recognized through profit or loss for the portion representing the costs of services rendered and through other comprehensive income (loss) for the portion representing the actuarial gains and losses. Service costs are recognized in profit or loss and are allocated by function. Actuarial gains and losses result from changes in actuarial assumptions and from differences between assumed and actual experience. Gains and losses recorded in other comprehensive income (loss) are amortized over expected remaining service periods to the extent they exceed 10% of the projected benefit obligation for the defined benefit plan. The Company’s payments for the defined-contribution plans are recognized as expenses in the Consolidated Statements of Operations and Comprehensive Loss for the period with which they are associated. Contingencies An estimated loss from a loss contingency is recognized if the following two conditions are met: • information available before the consolidated financial statements are issued indicates that it is probable that an asset had been impaired or a liability had been incurred at the date of the consolidated financial statements; and • the amount of loss can be reasonably estimated. With respect to litigations and claims that may result in a liability to be recognized, we exercise significant judgment in measuring and recognizing a liability or determining exposure to contingent liabilities that are related to pending litigation or other outstanding claims. These judgment and estimates are subject to change as new information becomes available. Operating Income The Company accounts for revenue when the amount can be reliably assessed, future economic benefits are likely to benefit the Company, and specific criteria are met for the Company’s business, which is in accordance with ASC 606 for the collaboration agreement with Nestlé Health Science. F-1 4 Table of Contents Other operating income 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. 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. Collaboration agreement with Nestlé Health Science The Company entered into research and development collaboration agreements that may consist of non-refundable upfront payments and milestone payments. Non-refundable upfront payments are deferred and recognized as income over the period of the collaboration agreement. Milestone payments represent amounts received depending upon the achievement of certain scientific, regulatory, or commercial milestones. They are recognized when the triggering event has occurred, there are no further contingencies or services to be provided with respect to that event, and the co-contracting party has no right to require refund of payment. The triggering event may be scientific results achieved by the Company or another party to the arrangement, regulatory approvals, or the marketing of products developed under the arrangement. 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. The Company accrued for any excess between costs yet to be incurred and income yet to be recognized for the completion of the performance obligations. Please refer to Note 13 “Contingencies”. Research and Development Expenditures Research and development expenditures are charged to expense as costs are incurred in performing research and development activities. Research and development costs include all direct costs, including salaries, share-based payments and benefits for research and development personnel, outside consultants, costs of clinical trials, costs related to manufacturing clinical study materials, sponsored research, clinical trials insurance, other outside costs, depreciation, and facility costs related to the development of drug candidates. The Company records upfront, non-refundable payments made to outside vendors, or other payments made in advance of services performed or goods being delivered, as prepaid expenses, which are expensed as services are performed or the goods are delivered. Certain research and development projects are, or have been, partially funded by collaboration agreements, and the expenses related to these activities are included in research and development costs. The Company records the F-1 5 Table of Contents 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. Share-based payments Since its incorporation, the Company has established several plans for equity compensation issued in the form of employee warrants (bons de souscription de parts de créateur 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. These awards are measured at their fair value on the date of grant. Except for RSUs, fair value is estimated using Black and Scholes models that require inputs based on certain subjective assumptions, including the expected term of the award, and the conditions of each equity plan. The fair value is amortized in personnel expenses (allocated by function in the Consolidated Statements of Operations and Comprehensive Loss) on a straight-line basis over the requisite service period, and such expense is reduced for estimated forfeitures, with a corresponding increase in shareholders’ equity. The determination of the requisite service period and the estimate of RSUs awards that are expected to vest depends on the legal interpretation of the RSUs award agreements with employees under the French labor laws and related jurisprudence. Changes in interpretations could significantly impact the accounting for the share- based payments. At each closing date, the Company re-assesses the number of options expected to vest. If applicable, the impacts of such revised estimates are recognized in the Consolidated Statements of Operations and Comprehensive Loss, with a corresponding adjustment in shareholders’ equity. The awards are not subject to any market conditions. Income Tax Income taxes are accounted for under the asset and liability method of accounting. Deferred taxes are recognized for the future tax consequences attributable to temporary differences between the financial reporting carrying amounts and tax bases of assets and liabilities, and on tax losses, using the liability method. Differences are defined as temporary when they are expected to reverse within a foreseeable future. The Company may only recognize deferred tax assets on net operating losses if, based on the projected taxable incomes within the next three years, management determines that it is probable that future taxable profit will be available against which the unused tax losses and tax credits can be utilized. As a result, the measurement of deferred income tax assets is reduced, if necessary, by a valuation allowance for any tax benefits which are not expected to be realized. If future taxable profits are considerably different from those forecasted that support recording deferred tax assets, the Company will have to revise downwards or upwards the amount of deferred tax assets, which would have a significant impact on the Company’s financial results. Tax assets and liabilities are not discounted. Amounts recognized in the Consolidated Financial Statements are calculated at the level of each tax entity included in the consolidation scope. Deferred tax assets and liabilities are measured using the enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes are enacted. Uncertain tax position Tax benefits are recognized from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities based on the technical merits of the position. F-1 6 Table of Contents Segment Information The Company operates in a single operating segment: the conducting of research and development of epicutaneous immunotherapy products in order to market them in the future. The assets, liabilities, and operating losses recognized are primarily located in France. Other Items in the Comprehensive Loss Comprehensive loss is comprised of net income(loss) and other comprehensive income (loss). Other comprehensive income (loss) includes changes in equity that are excluded from net income (loss), such as foreign currency translation adjustments. These changes in equity are presented net of tax. Net Loss Per Share The Company calculates basic and diluted net loss per ordinary share by dividing the net loss by the weighted- average number of ordinary shares outstanding during the period. For the years ended December 31, 2023 and 2022, the Company has excluded the effects of all potentially dilutive shares, which include outstanding ordinary stock options, warrants to purchase ordinary shares, and restricted stock units, from the weighted-average number of ordinary shares outstanding as their inclusion in the computation for these years would be anti-dilutive due to net losses incurred. Subsequent Events The Consolidated Statements of Financial Position and the Consolidated Statements of Operations 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. Accounting Pronouncements adopted in 2023 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. 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. F-1 7 Table of Contents Note 2 Significant Events and Transactions of the Periods Clinical programs United States Regulatory History and Current Status In January 2021, the Company received written responses from the FDA to questions provided in the Type A meeting request the Company submitted in October 2020 following the CRL. The FDA agreed with its position that a modified Viaskin Peanut patch should not be considered as a new product entity provided the occlusion chamber of the current Viaskin Peanut patch and the peanut protein dose of 250 m g (approximately 1/1,000 of one peanut) remains unchanged and performs in the same way it has performed previously. In order to confirm the consistency of efficacy data between the existing and a modified patch, FDA requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 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 Company later named this clinical trial STAMP, which stands for Safety, Tolerability, and Adhesion of Modified Patches. Based on the January 2021 FDA feedback, the Company defined three parallel workstreams: 1. Identify a modified Viaskin patch (which the Company calls mVP). 2. Generate the 6-month safety and adhesion clinical data FDA requested via STAMP, which the Company expected to be the longest component of the mVP clinical plan. The Company prioritized the STAMP protocol submission so the Company could begin the clinical trial as soon as possible. 3. Demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population via EQUAL. The complexity of EQUAL hinged on the lack of established clinical and regulatory criteria to characterize allergen uptake via an epicutaneous patch. To support those exchanges, the Company outlined its proposed approach to demonstrate allergen uptake equivalence between the two patches, and allotted time to generate informative data through two additional Phase 1 clinical trials in healthy adult volunteers: a. PREQUAL, a Phase 1 trial with adult healthy volunteers to optimize the allergen sample collection methodologies and validate the assays we intend to use in EQUAL. The data collection phase of the trial is complete, and the data analysis phase is ongoing. b. ‘EQUAL in adults’—a second Phase 1 trial with adult healthy volunteers to compare the allergen uptake of cVP and mVP. In March 2021, the Company commenced CHAMP (Comparison of adHesion Among Modified Patches), a Phase 1 trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches . The Company completed CHAMP in the second quarter of 2021. All modified Viaskin Peanut patches demonstrated better adhesion performance as compared to the then-current Viaskin Peanut patch, and based on the results of CHAMP, the Company then selected two modified patches that performed best out of the five modified patches studied for further development. The Company then selected the circular patch for further development, which is approximately 50% larger in size relative to the current patch and circular in shape. In May 2021, the Company submitted its proposed STAMP protocol to the FDA, and on October 14, 2021, the Company received an Advice/Information Request letter from the FDA. In this letter, the FDA requested a stepwise approach to the modified Viaskin patch development program and provided partial feedback on the STAMP protocol. Specifically, the FDA requested that the Company conducts allergen uptake comparison trials (i.e., ‘EQUAL in Adults’, EQUAL), and submits the allergen uptake comparison data for FDA review and feedback prior to starting the STAMP study. The FDA’s explanation was that the results from the allergen uptake studies might affect the design of the STAMP study. F-18 Table of Contents 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. As such, in December 2021, the Company announced its plan to initiate a pivotal Phase 3 placebo-controlled efficacy trial for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. The Company considers this approach the most straightforward to potentially demonstrate effectiveness, safety, and improved in vivo adhesion of the modified Viaskin Peanut system. The FDA confirmed the Company’s change in strategy was agreeable via oral and written exchanges. In 2022, the Company announced the new Phase 3 pivotal study of the modified Viaskin Peanut (mVP) patch would be in younger (4-7 years old) and more sensitive children with peanut allergy. On March 2, 2023, the Company announced the completion of EVOLVE, a 12-week caregiver and patient user experience study of the mVP patch in 50 peanut allergic children ages 4–11-years old. The objective of EVOLVE was to evaluate the Instructions for Use (IFU) and ease of use for the mVP patch. The study concluded that the updated IFU supported correct patch application, which included no lifting of the patch edges or detachment directly after application. Furthermore, EVOLVE concluded that the majority of parents/caregivers reported a positive ease of use experience with the mVP patch. In EVOLVE, DBV also tested the functionality of an electronic patient diary (eDiary) to collect information on activities of daily living and patch adhesion scores. EVOLVE verified that the eDiary tool can be used by caregivers in VITESSE to capture the adhesion data in support of a potential BLA. On March 7, 2023, the Company announced that the first patient was screened in the VITESSE study. Screening of the last patient is anticipated by Q3 2024. On April 19, 2023, the Company outlined the regulatory path for Viaskin Peanut in children 1-3 years old after the FDA confirmed that the Company’s Phase 3 EPITOPE study meets the pre-specified criteria for success for the primary endpoint, not requesting any additional efficacy study. The FDA requires additional safety data to augment the safety data collected from EPITOPE in support of a BLA. This new safety study will also generate patch adhesion data and will include updated instructions for use. On July 31, 2023, the Company announced receipt of feedback from FDA on the two supplemental safety studies, COMFORT Children and COMFORT Toddlers. The COMFORT Toddlers safety study will enroll peanut allergic toddlers ages 1 – 3-years and will support the efficacy results generated from the EPITOPE Phase 3 pivotal study. The COMFORT Children safety study will enroll peanut allergic children ages 4 – 7-years and will support the efficacy results anticipated from the ongoing VITESSE Phase 3 pivotal study. FDA agreed with a 6-month study duration and a 3:1 randomization (active:placebo) of approximately 400 subjects in the double-blind, placebo-controlled COMFORT Toddlers study. The Company expects both COMFORT studies will assess adhesion using the same tools and measurements that were established in VITESSE. Viaskin Peanut for children ages 4-11—European Union Regulatory History and Current Status On August 2, 2021, the Company announced it received from the EMA the Day 180 list of outstanding issues, which is an established part of the prescribed EMA review process. It is a letter that is meant to include any remaining questions or objections at that stage in the process. The EMA indicated many of their objections and major objections from the Day 120 list of questions had been answered. One major objection remained at Day 180. The Major Objection questioned the limitations of the data, for example, the clinical relevance and effect size supported by a single pivotal study. 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 F-19 Table of Contents 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. The Company believe data from a second Viaskin Peanut pivotal clinical trial will support a more robust path for licensure of Viaskin Peanut in the EU. The Company intend to resubmit the MAA when that data set is available. Viaskin Peanut for Children ages 1-3 In June 2020, the Company announced that in Part A, patients in both treatment arms showed consistent treatment effect after 12 months of therapy, as assessed by a double-blind placebo- controlled food challenge and biomarker results. Part A subjects were not included in Part B and the efficacy analyses from Part A were not statistically powered to demonstrate superiority of either dose versus placebo. These results validate the ongoing investigation of the 250 µg dose in this age group, which is the dose being studied in Part B of the study. Enrollment of Part B of EPITOPE was complete in first quarter of 2021. In June 2022, we announced positive topline results from Part B of EPITOPE, which enrolled 362 subjects ages 1 to 3 years, of which 244 and 118 were in the active and placebo arms, respectively. Enrollment was balanced for age and baseline disease characteristics between the active and placebo treatment arms. The Company intends to further analyze the data from EPITOPE and explore regulatory pathways for Viaskin Peanut in children ages 1 to 3 years, given the high unmet need and absence of approved treatments for this vulnerable population. On April 19, 2023, the Company announced it will begin a new safety study after it received confirmation from the FDA that the EPITOPE study meets the pre-specified criteria for success for the primary endpoint, with no additional efficacy study requested. This safety study will increase the safety data collected from EPITOPE in support of a BLA. It will also generate patch adhesion data and will include updated instructions for use. On May 10, 2023, the New England Journal of Medicine (NEJM) published results that demonstrated epicutaneous immunotherapy (EPIT) with VP was statistically superior to placebo in desensitizing children to peanut exposure by increasing the peanut dose that triggers allergic symptoms. As stated in an accompanying editorial piece, these data are seen as “very good news” for toddlers with peanut allergy, as there are currently no approved treatment options for peanut-allergic children under the age of 4 years. Following this publication, the Company confirmed it is advancing regulatory efforts for VP in toddlers ages 1-3 years old with a confirmed peanut allergy. In November 2023, the Company announced the interim analyses from the first year of the open-label extension of EPITOPE. These data were presented at the annual American College of Allergy, Asthma and Immunology (ACAAI) in November 2023. Viaskin Peanut for Children ages 4-7 On September 7, 2022, we announced the initiation of VITESSE, a new Phase 3 pivotal study of the modified Viaskin Peanut (mVP) patch in children ages 4-7 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. On September 21, 2022, we announced we had received feedback from the FDA in the form of a partial clinical hold on VITESSE. In the partial clinical hold letter, the FDA specified changes to elements of the VITESSE protocol, acknowledging the intent for the trial to support a future BLA submission. In the following months, we engaged with the FDA to address the feedback provided in the partial clinical hold letter and to finalize the VITESSE protocol. In addition, we continued internal preparations for VITESSE and conducted certain site assessment and start-up activities for prompt study launch once the partial clinical hold was lifted. F-20 Table of Contents On December 23, 2022, we announced the FDA lifted the partial clinical hold and confirmed we satisfactorily addressed all clinical hold issues. The FDA stated that VITESSE may proceed with the revised trial protocol. 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 years old. The additional safety data generated by this study will supplement the safety data generated by the VITESSE trial, resulting in a safety database comprised of approximately 600 children ages 4 to 7 years treated with Viaskin Peanut. This study is expected to be similar to the REALISE (REAL Life Use and Safety of EPIT) safety study that we previously conducted with Viaskin Peanut in children ages 4 to 11 years. Diagnostic Tool Development On October 30, 2023, the Company and NESTEC entered into a Mutual Termination Letter Agreement terminating the Collaboration Agreement. Each party remains responsible for its own costs and expenses related to its respective wind –down activities. Any and all licenses and sublicenses, granted by either party to the other party under the Collaboration Agreement, including, without limitation, any licenses to intellectual property, were revoked and terminated. Consequently, since signing the Mutual Termination Letter Agreement and as of December 31, 2023, we recorded the following: • Loss on completion accrual reversal $ 19,9 millions (Other Operating Income); • Deferred revenue accrual reversal $ 6.9 millions (Operating Expenses); • Accrual for ongoing Clinical study completion $ 2.3 millions (Operating Expenses). This accrual represents our best estimate of the remainder expenses related to the ongoing clinical study which will be incurred after December 31, 2023 and until the end of the study. Financing 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 2022 F-2 1 Table of Contents PIPE ”). 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 59,269,629 ordinary shares issued in the June 2022 PIPE, including ordinary shares underlying the pre-funded warrants. Legal Proceedings From time to time, we may become subject to various legal proceedings and claims that arise in the ordinary course of our business activities. We are not currently subject to any material legal proceedings. Note 3 Cash and Cash Equivalents The following table presents for each reported period, the breakdown of cash and cash equivalents: December 31, 2023 2022 Cash 10,530 30,104 Cash equivalents 130,826 179,090 Total cash and cash equivalents as reported in statement of financial position 141,367 209,194 Bank overdrafts —   —   Total net cash and cash equivalents as reported in the statement of cash flow 141,367 209,194 Cash equivalents are immediately convertible into cash at no or insignificant cost on demand. They are measured using level 1 fair value measurements. Note 4 Other Current Assets Other current assets consisted of the following: December 31, 2023 2022 Research tax credit 8,857 5,792 Other tax claims 5,236 3,903 Prepaid expenses 2,103 2,680 Other receivables 1,353 1,504 Total 17,548 13,880 The other tax claims are primarily related to deductible VAT. Prepaid expenses are comprised primarily of insurance expenses, as well as legal and scientific consulting fees. Prepaid expenses also include upfront payments which are recognized over the term of the ongoing clinical studies. F-2 2 Table of Contents 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. 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 ; • 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: Amount in thousands of US Dollars Opening balance sheet receivable as of January 1, 2022 28,092 + 2022 fiscal year research tax credit 5,718 - Payment received ( 26,117 ) - Adjustment and currency translation effect ( 1,901 ) Closing balance sheet receivable as of December 31, 2022 5,792 Of which—Non-current portion —   Of which—Current portion 5,792 Amount in thousands of US Dollars Opening balance sheet receivable as of January 1, 2023 5,792 + 2023 fiscal year research tax credit (1) 8,766 - Payment received ( 5,971 ) - Adjustment and currency translation effect 271 Closing balance sheet receivable as of December 31, 2023 8,857 Of which—Non-current portion —   Of which—Current portion 8,857 (1) Included 2020, 2021 and 2022 complementary research tax credit made during the fiscal year ended December 31, 2023 F-2 3 Table of Contents Note 5 Property, Plant, and Equipment Property and equipment, net consisted of the follo wi ng: 1/1/2022 Currency translation effect Increase Decrease Reclassification 12/31/2022 Laboratory equipment 21,434 ( 1,246 ) —  —  270 20,459 Building fixtures 3,958 ( 196 ) 55 ( 604 ) —  3,214 Office equipment 864 ( 25 ) 74 ( 428 ) —  485 Computer equipment 1,299 ( 65 ) 16 —  8 1,258 Property, plant, and equipment in progress 4,390 ( 252 ) 608 —  ( 278 ) 4,468 Total, gross 31,945 ( 1,783 ) 754 ( 1,032 ) —   29,884 Less accumulated amort. and deprec. ( 13,799 ) 703 ( 2,723 ) 1,031 —  ( 14,788 ) Total, net 18,146 ( 1,080 ) ( 1,968 ) ( 1 ) —   15,096 1/1/2023 Currency translation effect Increase Decrease Reclassification 12/31/2023 Laboratory equipment 20,459 815 —  —  3,565 24,839 Building fixtures 3,214 114 —  —  3,327 Office equipment 485 5 53 —  552 Computer equipment 1,258 40 —  126 1,425 Property, plant, and equipment in progress 4,468 91 625 —  ( 3,750 ) 1,433 Total, gross 29,884 1,074 677 —  ( 59 ) 31,577 Less accumulated amortization and depreciation ( 14,788 ) ( 60 ) ( 3,566 ) —  —  ( 18,954 ) Total, net 15,096 474 ( 2,889 ) —  ( 59 ) 12,623 The depreciation and amortization expense for each of the years ended December 31, 2023 and 2022 was $ 3.6 million and $ 2.7 million respectively. F-24 Table of Contents Note 6 Lease contracts Future minimum lease payments under the Company’s operating leases’ right of use as of December 31, 2023 and 2022, are as follows: December 31, 2023 December 31, 2022 Real estate Other assets Total Real estate Other assets Total Current portion 1,205 71 1,275 1,972 79 2,051 Year 2 65 11 75 1,168 74 1,243 Year 3 421 —   412 65 6 71 Year 4 919 —   919 —   —   —   Year 5 919 —   919 —   —   —   Thereafter 3,677 —   3,677 —   —   —   Total minimum lease payments 7,205 81 7,286 3,204 160 3,364 Less: Effects of discounting ( 1,617 ) ( 9 ) ( 1,626 ) ( 325 ) ( 17 ) ( 343 ) Present value of operating lease 5,588 73 5,661 2,879 143 3,021 Less: current portion ( 1,072 ) ( 68 ) ( 1,144 ) ( 1,823 ) ( 71 ) ( 1,894 ) Long-term operating lease 4,516 5 4,526 1,055 72 1,127 Weighted average remaining lease term (years) 7.954 —  1.40 —  Weighted average discount rate 4.53 % 2.50 % 3.00 % 2.45 % The Company recognizes rent expense, calculated as the remaining cost of the lease allocated over the remaining lease term on a straight-line basis. Rent expense presented in the consolidated statement of operations and comprehensive loss was: December 31, 2023 2022 Operating lease expense 1,776 1,800 Refurbishing impact 1,750 —   Net termination impact ( 92 ) ( 1,657 ) In January 2022, the company entered into a termination agreement for its U.S. office in Summit, NJ, following the resizing of its facility use. The Company recognized an income of $ 1.2 million as of June 30, 2022 due to the early termination of its Summit, NJ lease, offset by the payment of a one-time lump sum early termination fee of $ 1.5 million. On March 28, 2022 , the Company entered into a binding office lease agreement in New Jersey for a lease term of 3 years and 2 months . The lease commencement was based upon delivery of possession of the premises by the Landlord and occurred on April 1, 2022. Right of use and related lease debt have been recorded starting April 1, 2022 for a gross amount of $ 0.4 million. In November, 2023, the Company signed agreements for the new headquarters in Chatillon, France: • a short term lease agreement in order to fit the new offices, • A lease agreement starting on April 16, 2024 The lease commencement was based upon delivery of possession of the premises by the Landlord and occurred in November, 2023. Right of use and related lease debt have been recorded starting November, 2023 for a gross amount of $ 4.5 millions . F-2 5 Table of Contents Supplemental cash flow information related to operating leases is as follows for the year ended December 31, 2023 and 2022: December 31, 2023 2022 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases 1,956 2,195 Note 7 Other non-current assets Other non-current assets consisted of the following: December 31, 2023 2022 FX facility collateral account 3,904 3,739 Deposits, pledged securities and other non-current financial assets 2,104 1,773 Liquidity contract 166 312 Total other non-current assets 6,144 5,824 The other non-current assets are composed of security deposits paid to premises lessors, pledged securities, the liquidity contract and a collateral account to guarantee a FX facility not used as of December 31, 2023. Under the liquidity contract, 222,988 treasury shares were allocated as a reduction of Shareholders’ Equity as at December 31, 2023 with the cash balance being maintained in financial assets. Note 8 Trade payables and Other Current Liabilities Trade Payables No discounting was performed on the trade payables to the extent that the amounts did not present payment terms longer than one year at the end of each fiscal year presented. Other Current Liabilities Other current liabilities consisted of the following: December 31, 2023 2022 Social debt 7,828 5,872 Deferred income —   2,137 Tax liabilities 223 69 Other debts 883 1,131 Total 8,934 9,210 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 NESTEC. F-2 6 Table of Contents 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 Liabilities Due dates of liabilities The following table shows the maturity of the Company’s liabilities (except leases disclosed in Note 6—“Lease contract”): Total 2024 2025 Thereafter Other current liabilities 8,934 8,934 —   —  Supplier accounts payable and related payables 23,302 23,302 —  —  Total liabilities 32,236 32,236 —   —  The current portion of other liabilities mainly includes social security . Other non-current liabilities 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 The Company reports assets and liabilities recorded at fair value on the Company’s consolidated balance sheets based upon the level of judgment associated with inputs used to measure their fair value. The fair value measurement level within the fair value hierarchy for a particular asset or liability is based on the lowest level of any input that is significant to the fair value measurement. Valuation techniques maximize the use of observable inputs and minimize the use of unobservable inputs. Financial instruments not measured at fair value on the Company’s consolidated statement of financial position, but which require disclosure of their fair values include cash and cash equivalents, accounts receivable, deposits, liquidity contract, accounts payable and conditional advances. The fair values of these financial instruments are deemed to approximate their carrying amount. The fair values of cash and cash equivalents, accounts receivable, deposits, liquidity contract and accounts payable are categorized as Level 1. The fair value of conditional advance was categorized as Level 2 and was estimated based on a discounted cash flow method using the effective interest rate. For the interest-free conditional advances, the discount rate applied is equal to the rate of fungible treasury bonds over the time period that corresponds to the time period of the repayment of the advances. There has been no transfer between levels of the fair value hierarchy during the years ended December 31, 2022 and 2023. Note 11 Share Capital Issued The share capital, as of December 31, 2023, is set at the sum of € 9,643,177 ($ 10,972,101 converted at historical rates). It is divided into 96,431,770 fully authorized, subscribed and paid-up shares with a nominal value of € 0.10 . F-2 7 Table of Contents 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, 2022 (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; • sub-delegated its authority to the Chief Executive Officer for the purpose of implementing the financing. The Chief Executive Officer, acting pursuant to the sub-delegations of authority granted by the Board of Directors of the Company on June 8, 2022, after receiving the favorable opinion of the Pricing Committee established by the Board of Directors, has, on June 9, 2022: • decided, making use of the 18 th resolution of the Board General Meeting, to proceed with a capital increase in cash with cancellation of preferential subscription rights reserved for categories of investors, in accordance with the Article L. 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. a capital increase of a nominal amount of € 3,285,566.90 together with a share premium of € 95,281,440.10 , i.e. a gross amount of the capital increase of € 98,567,007 , and (ii) 28,276,331 prefunded warrants to be subscribed in cash by paying up on the date of issue of € 82,001,359.90 corresponding to the prepayment of the subscription price of the new ordinary shares in the event of exercise of the prefunded warrants, • decided to set the maximum nominal amount of the capital increase resulting from the full exercise of the prefunded warrants at € 2,827,633.10 , by issuing a maximum of 28,276,331 ordinary shares, with a value of € 0.10 to be subscribed in cash at the price of € 0.10 euro (without share premium), and to be fully paid up at the time of subscription, i.e. a capital increase of a maximum nominal amount of € 2,827,633.10 (and a share premium corresponding to the amount of the pre-financed price released in advance at the time of the subscription of the prefunded warrants ), being specified that this amount does not take into account the nominal value of the ordinary shares to be issued in order to preserve the rights of the holders of securities giving access to the capital issued or to be issued, in accordance with the legal and regulatory provisions and the contractual stipulations providing for other cases of adjustment if necessary; • 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. F-2 8 Table of Contents The 2022 Warrants are classified as a component of permanent equity because they are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock with which they were issued, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permit the holders to receive a fixed number of shares of common stock upon exercise. In addition, the 2022 Warrants do not provide any guarantee of value or return. Accordingly, the pre-funded warrants are classified as equity and accounted for as a component of additional paid-in capital at the time of issuance. The changes in number of outstanding prefunded warrants are as follows: Prefunded warrants Balance as of December 31, 2022 28,276,331 Granted during the period — Forfeited during the period —   Exercised/released during the period —   Expired during the period —   Balance as of December 31, 2023 28,276,331 F- 29 Table of Contents The table below presents the changes in the share capital of the Company as of December 31, 2022 and 2023: (Amounts in thousands of U.S. Dollars except share and per share data) Date Nature of the transactions Share capital* Additional paid-in capital Number of shares Balance as of December 31, 2021 6,538 358,115 55,095,762 03/23/2022 Capital increase by ordinary shares 0 ( 0 ) 775 05/10/2022 Capital increase by ATM program 637 13,442 6,036,238 05/12/2022 Retained earnings charged on share premium ( 95,209 ) 05/19/2022 Capital increase by employee warrants 1 ( 1 ) 5,000 05/24/2022 Capital increase by employee warrants 3 ( 3 ) 26,135 06/09/2022 Capital increase by ordinary shares 3,530 88,743 32,855,669 06/09/2022 Capital increase by share warrants 88,094 06/10/2022 Capital increase by employee warrants 0 13 3,100 07/08/2022 Capital increase by employee warrants 0 10 2,513 09/23/2022 Capital increase by ordinary shares 0 ( 0 ) 249 11/19/2022 Capital increase by ordinary shares 0 ( 0 ) 2,500 11/22/2022 Capital increase by ordinary shares 3 ( 3 ) 30,625 11/24/2022 Capital increase by ordinary shares 8 ( 8 ) 78,579 12/31/2021 Share-based payments 5,026 Balance as of December 31, 2022 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 09/23/2023 Capital increase by ordinary shares 0 ( 0 ) 2,599 10/25/2023 Capital increase by ordinary shares 4 ( 4 ) 35,000 11/19/2023 Capital increase by ordinary shares 0 ( 0 ) 2,500 11/21/2023 Capital increase by ordinary shares 6 ( 6 ) 57,775 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 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 € 93.4 millions ($ 88.7 millions converted at historical rates). F-3 0 Table of Contents 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: Share-based payments instrument General meeting of shareholders Board of directors meeting Grant date Number granted BSA 12/9/11 9/25/12 9/25/12 30,000 BSA 6/4/13 7/25/13 7/25/13 73,000 SO 12/9/11 9/18/13 9/18/13 518,000 BSA 6/3/14 3/24/15 3/24/15 10,000 SO 6/3/14 6/23/15 6/23/15 120,000 BSA 6/23/15 11/19/15 11/19/15 22,500 BSA 6/23/15 12/15/15 2/15/16 90,000 SO 6/3/14 4/6/16 4/21/16 33,000 SO 6/3/14 6/21/16 6/21/16 110,000 BSA 6/21/16 6/21/16 8/21/16 20,000 SO 6/3/14 6/21/16 9/15/16 9,300 SO 6/3/14 6/21/16 10/17/16 16,500 BSA 6/21/16 12/9/16 2/9/16 59,000 SO 6/3/14 6/21/16 12/9/16 74,960 RSU 9/21/15 3/14/17 3/14/17 22,500 RSU 9/21/15 4/20/17 4/20/17 24,000 BSA 6/15/17 6/15/17 8/15/17 9,000 SO 6/3/14 6/15/17 6/15/17 126,000 SO 6/15/17 6/15/17 6/15/17 111,600 SO 6/15/17 6/15/17 9/15/17 52,600 SO 6/15/17 11/17/17 12/5/17 625,200 BSA 6/15/17 5/2/18 7/2/18 44,000 RSU 6/22/18 6/22/18 6/22/18 486,153 RSU 6/22/18 9/6/18 9/6/18 450 SO 6/22/18 9/6/18 9/6/18 65,000 SO 6/22/18 6/22/18 10/15/18 76,700 RSU 6/22/18 11/1/18 11/1/18 57,000 SO 6/22/18 11/29/18 11/29/18 350,000 RSU 6/22/18 12/12/18 12/12/18 16,250 RSU 6/22/18 12/12/18 12/17/18 3,000 SO 6/22/18 3/4/19 3/20/19 547,100 RSU 6/22/18 5/10/19 5/10/19 100,000 SO 5/24/19 5/24/19 5/24/19 150,000 SO 5/24/19 7/1/19 7/1/19 403,400 SO 5/24/19 7/1/19 7/22/19 75,000 RSU 5/24/19 10/11/19 10/11/19 40,000 SO 5/24/19 10/11/19 1/15/20 94,500 RSU 5/24/19 10/11/19 3/16/20 5,000 RSU 4/20/20 4/20/20 4/29/20 20,000 RSU 4/20/20 11/24/20 11/24/20 475,000 SO 4/20/20 11/24/20 11/24/20 1,216,200 RSU 4/20/20 3/23/21 3/23/21 24,900 SO 4/20/20 3/23/21 3/23/21 75,200 RSU 5/19/21 5/19/21 5/19/21 20,000 F- 3 1 Table of Contents Share-based payments instrument General meeting of shareholders Board of directors meeting Grant date Number granted BSA 5/19/21 5/19/21 6/3/21 39,185 RSU 5/19/21 11/22/21 11/22/21 257,300 SO 5/19/21 11/22/21 11/22/21 1,107,300 RSU 5/19/21 5/12/22 5/12/22 3,200 SO 5/19/21 5/12/22 5/12/22 19,000 RSU 5/12/22 7/29/22 7/29/22 66,700 SO 5/12/22 7/29/22 7/29/22 135,500 RSU 5/12/22 11/21/22 11/21/22 519,650 SO 5/12/22 11/21/22 11/21/22 1,771,786 RSU 4/12/23 1/09/23 1/9/23 35,800 SO 4/12/23 1/09/23 1/9/23 59,200 RSU 4/12/23 11/20/23 11/20/23 912,650 SO 4/12/23 11/20/23 11/20/23 2,290,722 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 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. The BSAs plans granted by the Board of Directors until 2018 are similar in their nature and conditions, except for the exercise price that is comprised between € 5.13 and € 69.75 . During the year ended December 31, 2021, pursuant to the authorization granted by the General Meeting of the Shareholders held on May 19, 2021, the Company offered the directors the opportunity to subscribe for warrants to purchase ordinary shares on May 19, 2021, and on June 3, 2021, the directors subscribed for warrants to purchase an aggregate of 39,185 ordinary shares. These warrants have a contractual life of 4 years from their date of issuance and are not subject to a performance condition. Unless otherwise decided by the Board of Directors, these warrants may be exercised at any time prior to their expiration, provided that the beneficiary still holds a seat on the Board of Directors at the time of exercise, and subject to applicable French laws and regulations applicable to companies whose securities are listed on a regulated stock market. The fair value of the warrants has been estimated using the Cox-Ross Rubinstein binomial option pricing model. Warrant fair value assumptions during the year ended December 31, 2021 Weighted average share price at grant date (in €) 10.75 Weighted average expected volatility 90.0 % Weighted average risk-free interest rate ( 0.53 )% Weighted average expected term (in years) 3.21 Dividend yield —   Weighted average fair value of warrants (in €) —   F-3 2 Table of Contents The following table summarizes all BSA warrants activity during the year ended December 31, 2022: 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, 2021 256,693 47.51 4.35 —  Granted during the period —   —   —  —  Forfeited during the period —  —  —  —  Exercised during the period —  —  —  —  Expired during the period ( 5,000 ) 8.59 —  —  Balance as of December 31, 2022 251,693 48.29 4.36 —  Warrants exercisable as of December 31, 2022 251,693 48.29 4.36 —  The following table summarizes all BSA activity during the year ended December 31, 2023: 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 —  Granted during the period —  —  —  —  Forfeited during the period —  —  —  —  Exercised during the period —  —  —  —  Expired during the period (7,000 ) — —  —  Balance as of December 31, 2023 244,693 48.29 4.35 —  Warrants exercisable as of December 31, 2023 244,693 48.29 4.35 —  12.2 Employee warrants As of December 31, 2023, no more BSPCE / BCE warrants (Bons de Souscription de Parts de Créateur d’Entreprise or “BSPCE”) are exercisable. 12.3 Stock options 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 € 2.00 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), F-3 3 Table of Contents • 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, • Performance condition: approval of Viaskin ™ Peanut by the US Food and Drug Administration, • Since November 22, 2021, 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), Performance conditions which are other than market conditions, are taken into account by adjusting the number of equity instruments included in the measurement of the transaction amount but are not taken into account when estimating the fair value of the shares. Estimated achievement of performance conditions is reviewed at each reporting date. The Company also applied a forfeiture rate for each grant according to its respective characteristics and composition. This forfeiture rate is reviewed at each reporting date. The following table summarizes all stock options activity during the year ended December 31, 2022: 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, 2021 3,631,210 15.25 8.67 Granted during the period 1,926,286 3.12 —  —  Forfeited during the period ( 245,314 ) 12.22 —  —  Exercised during the period ( 5,613 ) 4.16 —  —  Expired during the period —  —  —  —  Balance as of December 31, 2022 5,306,569 11.00 8.41 Options exercisable as of December 31, 2022 1,331,508 20.20 6.69 —  The following table summarizes all stock options activity during the year ended December 31, 2023: 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 ( 369,800 ) 3.76 —  —  Exercised during the period —   —   —  —  Expired during the period ( 168,000 ) —   —  —  Balance as of December 31, 2023 7,118,691 8.55 9.10 Options exercisable as of December 31, 2023 602,995 38.70 5.35 —  As of December 31, 2023, there was € 17.8 millions ($ 20.3 millions converted at closing rate) of unrecognized SO expense that is expected to be recognized over a weighted-average period of 7.5 years. F-3 4 Table of Contents Fair value of stock options Determining the fair value of the share-based payments at the grant date requires judgment. The Company calculated the fair value of stock options instruments on the grant date using the Black-Scholes option pricing model. The Black-Scholes model requires the input of highly subjective assumptions, including the expected volatility, expected term, risk-free interest rate and dividend yield. Exercise price The exercise price of the Company’s stock awards is based on the fair market value of our ordinary shares. Risk-free interest rate The risk-free interest rate is based on French government bonds (GFRN) with a maturity corresponding to the stock options maturity. Expected term The Company determines the expected term based on the average period the stock options are expected to remain outstanding. Expected Volatility The Company determines the expected volatility based on the historical data period corresponding to the stock options expected maturity. Expected Dividend yield The Company has never declared or paid any cash dividends, and it does not presently plan to pay cash dividends in the foreseeable future. Consequently, the Company uses an expected dividend yield of zero. The Company estimated the following assumptions for the calculation of the fair value of the stock options: Assumptions per year ended, December 31, Stock options per grant date 2017 2018 2019 2020 2021 2022 2023 Weighted average shares price at grant date in € 45.49 31.86 15.26 5.54 5.71 2.33 2.03 Weighted average expected volatility 41,80 % 47,10 % 70,80 % 87,30 % 90,20 % 98,90 % 93,70 % Weighted average risk-free interest rate - 0,10 % 0,30 % - 0,10 % - 0,50 % - 0,06 % 2,20 % 2,95 % Weighted average expected term (in years) 6,7 6 6 6 6 6 6 Dividend yield 0 0 0 0 0 —   —   Weighted average fair value of stock-options in € 17.16 13.67 9.65 3.9 4.17 2.23 1.67 12.4 Restricted stock units The Company’s board of directors has been authorized by the shareholders’ general meeting to grant RSUs to employees. RSUs are measured based on the fair market value of the underlying stock on the date of grant and recognized as an expense on a straight-line basis in accordance with the following vesting conditions: • Before May 31, 2019, the vesting of RSUs granted is subject to the expiration of the presence condition of one ( 1 ) or two ( 2 ) years (except in specific board of directors’ decisions). The release of RSUs for F-3 5 Table of Contents 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. FDA); • 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). Performance conditions, which are other than market conditions, are taken into account by adjusting the number of equity instruments included in the measurement of the transaction amount but are not taken into account when estimating the fair value of the shares. Estimated achievement of performance conditions is reviewed at each reporting date. RSU plans may be subject to a conservation period under French governing laws. The Company applied a forfeiture rate for each grant according to its respective characteristics and composition. This forfeiture rate is reviewed at each reporting date. The following table summarizes all RSUs activity for the year ended December 31, 2022: Number of RSU outstanding Weighted average grant date fair value in Euros Balance as of December 31, 2021 1,240,520 18.77 Granted during the period 589,550 2.67 Forfeited during the period (97 126 ) 4.96 Released during the period ( 143,863 ) 5.15 Expired during the period —   —  Balance as of December 31, 2022 1,589,081 14.69 The following table summarizes all RSUs activity for the year ended December 31, 2023: 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 589,550 1.69 Forfeited during the period ( 191,659 ) 4.04 Released during the period ( 250,355 ) 6.77 Expired during the period —   —  Balance as of December 31, 2023 2,095,517 10.73 F-3 6 Table of Contents As of December 31, 2023, there was € 2.5 millions ($ 2.7 millions 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 December 31, 2023 2022 Research and development SO ( 1,661 ) ( 1,462 ) RSU ( 835 ) ( 841 ) Sales and marketing SO ( 102 ) ( 31 ) RSU ( 33 ) ( 4 ) General and administrative SO ( 2,985 ) ( 2,374 ) RSU ( 403 ) ( 315 ) Total share-based compensation (expense) income ( 6,019 ) ( 5,026 ) Note 13 Contingencies Non-current contingencies and current contingencies break down as follows: December 31, 2023 2022 Current contingencies 3,959 3,944 Non-current contingencies 935 16,680 Total contingencies 4,894 20,625 F-3 7 Table of Contents The table below shows movements in contingencies: Pension retirement obligations Collaboration agreement—Loss at completion Other contingencies Total At January 1, 2022 1,008 9,800 45 10,853 Increases in liabilities 105 12,455 —   12,560 Used liabilities —  —  ( 42 ) ( 42 ) Reversals of unused liabilities —  ( 1,984 ) —   ( 1,984 ) Net interest related to employee benefits, an unwinding of discount —  —  —  —   Actuarial gains and losses on defined-benefit plans ( 262 ) —  —  ( 262 ) Currency translation effect ( 61 ) ( 436 ) ( 3 ) ( 500 ) At December 31, 2022 790 19,835 —  20,625 Of which Current —  3,944 —  3,944 Of which Non-current 790 15,891 —  16,680 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, and unwinding of discount —  —  —  —   Actuarial gains and losses on defined-benefit plans 38 —  —  38 Currency translation effect 31 273 85 389 At December 31, 2023 935 —   3,959 4,893 Of which Current —  —   3,959 3,959 Of which Non-current 935 —   —  935 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. F-3 8 Table of Contents As part of the estimation of the retirement commitments, the following assumptions were used for all categories of employees: December 31, 2023 2022 % Social security contributions 50.0 % 50.0 % Salary increases 2.0 % 2.0 % Discount rate—Iboxx Corporates AA 10+ 3.17 % 3.77 % Expected staff turnover 10.0 % 10.0 % Estimated retirement age 67 65 Life table TGH05-TGF05 Collective agreement National Collective Agreement of the pharmaceutical industry Note 14 Operating Income The operating income is broken down in the following manner: December 31, 2023 2022 Research tax credit 8,766 5,718 Other operating income . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6,962 ( 874 ) Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15,728 4,844 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 € 100.0 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 € 10.0 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 31 , 2023 , the Company recorded complementary research tax credit for $ 2.9 millions after having made a complementary statement for 2020, 2021 and 2022. F- 39 Table of Contents Note 15 Operating expenses and Allocation of Personnel Expenses Operating expenses Research and Development Expenses The following table summarizes our research and development expenses for the years presented: December 31, (Dollar amounts presented in thousands) 2023 2022 $ change % change Research and development expenses External clinical-related expenses 49,044 42,248 6,796 16 % Employee-related costs excl. share-based payment expenses 14,401 10,752 3,649 34 % Share-based payment expenses 2,496 2,303 193 8 % Depreciation and amortization ( 13,658 ) 12,965 ( 26,623 ) ( 205 %) Other costs 7,940 7,276 664 9 % Total Research and development expenses 60,223 75,543 ( 15,320 ) ( 20 %) 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. Sales and Marketing Expenses The following table summarizes our sales and marketing expenses for the years presented: December 31, (Dollar amounts presented in thousands) 2023 2022 $ change % change Sales and marketing expenses Employee-related costs incl. share-based payment expenses 754 914 ( 160 ) ( 18 %) External professional services and other costs 1,784 694 990 143 % Total Sales and marketing expenses 2,438 1,608 830 52 % 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. F-4 0 Table of Contents 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. General and Administrative Expenses The following table summarizes our general and administrative expenses for the years presented: December 31, (Dollar amounts presented in thousands) 2023 2022 $ change % change General and administrative expenses External professional services fees 8,750 5,947 2,803 47 % Employee-related costs excl. share-based payment expenses 8,200 7,320 881 12 % Share-based payment expenses 3,389 2,688 701 26 % Depreciation, amortization and other costs 9,161 8,369 2,523 30 % Total General and administrative expenses 29,500 24,324 5,176 21 % 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. Allocation of Personnel Expenses by Function: December 31, 2023 2022 Research and Development expenses 16,897 13,055 Sales and Marketing expenses 754 914 General and Administrative expenses 11,589 10,008 Total personnel expenses 29,240 23,977 F-4 1 Table of Contents Allocation of Personnel Expenses by Nature: December 31, 2023 2022 Wages and salaries 18,108 14,802 Social security contributions 4,176 3,206 Expenses for pension commitments 935 943 Share-based payments 6,019 5,026 Total 29,240 23,977 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. Note 16 Income Tax Reconciliation between the Effective and Nominal Income Tax Expense The following table shows the reconciliation between the effective and nominal tax expense at the nominal standard French rate 25 % as of December 31, 2023 and December 31, 2022 (excluding additional contributions): December 31, 2023 2022 (Loss) before taxes ( 72,709 ) ( 96,204 ) Theoretical company tax rate 25.00 % 25.00 % Nominal tax expense 18,179 24,051 Increase/decrease in tax expense arising from: Research tax credit 2,192 1,430 Share-based compensation ( 1,852 ) ( 784 ) Other permanent differences ( 110 ) ( 100 ) Non recognition of deferred tax assets mainly related to tax losses ( 18,802 ) ( 24,746 ) Other differences 386 79 Effective tax expenses—current ( 7 ) ( 70 ) Effective tax expenses—deferred —  —  Effective tax rate ( 0.01 )% ( 0.07 )% F-4 2 Table of Contents Deferred Tax Assets Deferred taxes are recognized for temporary differences between the basis of assets and liabilities for financial statement and income tax purposes. The significant components of the Company’s deferred tax assets are comprised of the following: December 31, 2023 2022 Deferred tax assets: Net operating loss carryforwards 307,300 273,964 Share-based compensation 509 1,102 Personnel-related accruals 422 389 Pension retirement obligations 509 197 Leases 32 6 Other 1,205 5,248 Total deferred tax assets 309,702 280,907 Less: Valuation allowance ( 309,702 ) ( 280,907 ) Net deferred tax assets —   —   Note 17 Commitments Purchase Obligations The Company has signed agreements with several contract research organizations (CRO) and part of the ongoing clinical studies for Viaskin ™ Peanuts and Viaskin ™ Milk products. 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. 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 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. December 31, 2023 2022 Short-term benefits 4,864 4,625 Post-employment benefits 29 33 Termination benefits — 24 Share-based payments 3,792 3,355 Total 8,685 8,037 F-4 3 Table of Contents 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, 2023 and 2022 are as follows: December 31, 202 3 2022 Compensation 2,112 2,009 Pension obligations 107 83 Total 2,219 2,092 Note 19 Loss Per Share The basic loss per share is calculated by dividing the net loss attributable to the shareholders of the Company by the weighted average number of ordinary shares outstanding during the course of the fiscal year. As the Company was in a loss position for the years ended December 31, 2023 and 2022, the diluted loss per share is equal to basic loss per share because the effects of potentially dilutive shares were anti-dilutive given the Company’s net loss. The computations for basic and diluted loss per share were as follows (in thousands of U.S. Dollars except share and per share data): December 31, 2023 2022 Net loss ( 72,726 ) ( 96,274 ) Weighted average number of ordinary shares 95,121,390 77,384,133 Basic and diluted net loss per share attributable to ordinary shareholders ($/share) ( 0.76 ) ( 1.24 ) 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: December 31, 2023 2022 Non-employee warrants 244,693 251,693 Employee warrants —   —   Stock-options 7,118,691 5,306,569 Restricted stock units 2,095,518 1,618,778 Prefunded warrants 28,276,331 28,276,331 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. F-4 4