16 unchanged sentences
Other Information.
−Removed: During the fiscal quarter ended December 31, 2024, none of our officers or directors, as defined in Rule 16a-1(f), adopted, modified or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” as those terms are defined in Item 408 of Regulation S-K.
+Added: During the fiscal quarter ended December 31, 2025, none of our officers or directors (as defined in Rule 16a-1(f) under the Securities Exchange Act of 1934, as amended) adopted, modified or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” as those terms are defined in Item 408 of Regulation S-K.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
2 unchanged sentences
Directors, Executive Officers and Corporate Governance.
−Removed: The information required by this Item 10 will be included in the 10-K/A or in the sections titled “Board of Directors and Corporate Governance,” “Information About Our Executive Officers,” “Code of Business Conduct and Ethics” and “ Insider Trading Policy ” in our Proxy Statement and is incorporated herein by reference.
+Added: The information required by this Item 10 will be included in the sections titled “Board of Directors and Corporate Governance,” “Information About Our Executive Officers,” “Code of Business Conduct and Ethics” and “ Insider Trading Policy ” in our Proxy Statement and is incorporated herein by reference.
We intend to promptly disclose on our website or in a Current Report on Form 8-K in the future (i) the date and nature of any amendment (other than technical, administrative or other non-substantive amendments) to the Code of Conduct that applies to our principal executive officer, principal financial officer, principal accounting officer or controller or persons performing similar functions and relates to any element of the code of ethics definition enumerated in Item 406(b) of Regulation S-K and (ii) the nature of any waiver, including an implicit waiver, from a provision of the Code of Conduct that is granted to one of these specified individuals that relates to one or more of the elements of the code of ethics definition enumerated in Item 406(b) of Regulation S-K, the name of such person who is granted the waiver and the date of the waiver.
1 unchanged sentence
The reference to our website address does not constitute incorporation by reference of the information contained at or available through our website, and you should not consider it to be a part of this Annual Report.
+Added: We have an insider trading policy governing the purchase, sale and disposition of our securities that applies to all of our personnel, including directors, officers, employees and other covered persons.
+Added: We believe that our insider trading policy is reasonably designed to promote compliance with insider trading laws, rules and regulations, and listing standards applicable to us.
+Added: A copy of our Insider Trading Policy is filed as Exhibit 19.1 to this Form 10-K.
Executive Compensation.
−Removed: The information required by this Item 11 will be included in the 10-K/A or in the sections titled “Executive Compensation” (excluding the information under the subheading “Pay Versus Performance”) and “Board of Directors and Corporate Governance” in our Proxy Statement and is incorporated herein by reference.
+Added: The information required by this Item 11 will be included in the sections titled “Executive Compensation” (excluding the information under the subheading “Pay Versus Performance”) and “Board of Directors and Corporate Governance” in our Proxy Statement and is incorporated herein by reference.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
−Removed: The information required by this Item 12 will be included in the 10-K/A or in the sections titled “Security Ownership of Certain Beneficial Owners and Management” and “Executive Compensation” in our Proxy Statement and is incorporated herein by reference.
+Added: The information required by this Item 12 will be included in the sections titled “Security Ownership of Certain Beneficial Owners and Management” and “Executive Compensation” in our Proxy Statement and is incorporated herein by reference.
Certain Relationships and Related Transactions, and Director Independence.
−Removed: The information required by this Item 13 will be included in the 10-K/A or in the sections titled “Board of Directors and Corporate Governance” and “Certain Relationships and Related Person Transactions” in our Proxy Statement and is incorporated herein by reference.
+Added: The information required by this Item 13 will be included in the sections titled “Board of Directors and Corporate Governance” and “Certain Relationships and Related Person Transactions” in our Proxy Statement and is incorporated herein by reference.
Principal Accountant Fees and Services.
−Removed: The information required by this Item 14 will be included in the 10-K/A or in the section titled “Audit Fees and Services” in our Proxy Statement and is incorporated herein by reference.
+Added: The information required by this Item 14 will be included in the section titled “Audit Fees and Services” in our Proxy Statement and is incorporated herein by reference.
Exhibits and Financial Statement Schedules.
10 unchanged sentences
Form F-1/A 333-198870 4.1 10/15/2014
−Removed: F orm of Amendment No.
+Added: Form of Amendment No.
1 to Deposit Agreement
−Removed: F orm of Amendment No.
+Added: Form of Amendment No.
2 to Deposit Agreement
10 unchanged sentences
Form 8-K 001-36697 10.1 06/13/2022
+Added: Form of Securities Purchase Agreement
+Added: Registration Rights Agreement, Dated March 27, 2025, by and between DBV Technologies S.A.
+Added: and the investor parties thereto.
10.1 Office Lease between the registrant and GENERALI VIE, dated March 3, 2025 (English translation)
64 unchanged sentences
S-8 333-280657 99.2 07/30/2024
+Added: 2 025 Stock Option Plan (English Translation)
+Added: 2025 Free Share Plan (English Translation
Executive Agreement, dated November 29, 2018, between the registration and Daniel Tassé
15 unchanged sentences
English Summary Translation of Letter Agreement dated as of December 16, 2024, amending the Employment Agreement dated November 6, 2023, by and between registrant and Virginie Boucinha
+Added: Executive Agreement, dated November 1, 2025, between the registrant and Kevin Trapp.
+Added: 10.44 Sales Agreement, dated as of September 5, 2025, by and between DBV Technologies S.A.
+Added: and Citizens JMP Securities, LLC
Securities Trading Policy
26 unchanged sentences
(Principal Executive Officer)
−Removed: Date:April 11, 2025
+Added: March 26, 2026
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.
−Removed: 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 April 11, 2025.
−Removed: Signature Title
+Added: 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 26, 2026.
/s/ Daniel Tassé
12 unchanged sentences
Danièle Guyot-Caparro
+Added: /s/ Philina Lee
/s/ Timothy E.
4 unchanged sentences
Ravi Madduri Rao
−Removed: /s/ Daniel Soland
−Removed: Daniel Soland
Index to Financial Statements
6 unchanged sentences
Consolidated Statements of Changes in Shareholders’ Equity for the Years Ended December 31, 2025 and 2024
−Removed: Notes to the Consolidated Financial Statements F - 8
+Added: Notes to the Consolidated Financial Statements
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMS
2 unchanged sentences
We have audited the accompanying consolidated statements of financial position of DBV Technologies S.A.
−Removed: and subsidiaries (the “Company”) as of December 31, 2024 and 2023, the related consolidated statements of operations and comprehensive loss, cash flows and changes in shareholders' equity for the years then ended, and the related notes (collectively referred to as the “consolidated financial statements”).
−Removed: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America.
+Added: and subsidiaries (the “Company”) as of December 31, 2025 and 2024, the related consolidated statements of operations and comprehensive loss, cash flows and changes in shareholders' equity for each of the years in the two-year period ended December 31, 2025, and the related notes (collectively referred to as the “consolidated financial statements”).
+Added: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the years in the two-year period ended December 31, 2025, in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
16 unchanged sentences
The communication of a critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
−Removed: Going Concern – Refer to Notes 1 and 20 to the consolidated financial statements
−Removed: Critical Audit Matter Description
−Removed: 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.
−Removed: 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.
−Removed: On April 7, 2025, the Company received gross proceeds of $125.5 million (€116.3 million) from the issuance of the ABSA and PFW-BS-PFW, as described further in Note 20.
−Removed: With the receipt of the aforementioned proceeds, and based on its current operations, plans, and assumptions, the Company estimates that its cash and cash equivalents are sufficient to fund its operations into June 2026.
−Removed: We identified the evaluation of the Company’s ability to continue as a going concern and related disclosures as a critical audit matter.
−Removed: This matter required a high degree of subjective auditor judgment when performing audit procedures to evaluate (1) the reasonableness of management’s forecasted operating expenses, and (2) the adequacy of the consolidated financial statements disclosure related to the going concern assessment.
−Removed: How the Critical Audit Matter was Addressed in the Audit
+Added: PFW-BS-PFW – Refer to Note 1 to the consolidated financial statements
+Added: As disclosed in Note 1 to the consolidated financial statements, on April 7, 2025, the Company completed a financing consisting of (i) the issuance of 34,090,004 new shares with attached warrants (ABSA Warrants) for an amount of $41 million (€38 million) and (ii) the issuance of 71,005,656 units (PFW‑BS‑PFW) for an amount of $85 million (€79 million).
+Added: Each PFW‑BS‑PFW unit comprised of one pre‑funded warrant to subscribe to one share of the Company (First Pre‑Funded Warrant) and one warrant (BS Warrant) to subscribe to one second pre‑funded warrant (Second Pre‑Funded Warrant).
+Added: Management concluded that the April 2025 PFW-BS-PFW met the conditions required for equity classification.
+Added: We identified the assessment of the accounting classification of the PFW‑BS‑PFW instruments, including the First and Second Pre‑Funded Warrants and related BS Warrants, as a critical audit matter.
+Added: Challenging auditor judgment and specialized skills and knowledge were required in assessing whether the PFW‑BS‑PFW instruments should be accounted for as either liabilities or equity instruments due to the interpretation of contract provisions within the warrant agreements and application of complex technical accounting guidance.
The following are the primary procedures we performed to address this critical audit matter.
−Removed: • We compared the Company’s historical forecasted operating expenses to actual results to assess the Company’s ability to accurately forecast.
−Removed: • We performed a sensitivity analysis over the Company’s forecasted cash flows by evaluating the effect of changes to the forecasted operating expenses on the Company’s going concern assessment.
−Removed: • We evaluated the reasonableness of the Company’s forecasted operating expenses by:
−Removed: ◦ inquiring of senior management to gain an understanding of the Company’s operations, strategy, and research and development activities;
−Removed: ◦ comparing the forecasted operating expenses to historical operating expenses;
−Removed: ◦ comparing forecasted operating expenses to management’s communications to the Board of Directors and public information disseminated by the Company.
−Removed: • We assessed the adequacy of the Company’s disclosures related to its going concern assessment by comparing the disclosures to the audit evidence obtained.
−Removed: /s/ Deloitte & Associés KPMG S.A.
+Added: We involved professionals with specialized skills and knowledge, who assisted in reading the underlying agreements to understand the relevant contract provisions and in evaluating whether the Company’s accounting classification of PFW‑BS‑PFW instruments, including the First and Second Pre‑Funded Warrants and related BS Warrants, was in accordance with the relevant complex technical accounting guidance.
+Added: /s/ Deloitte & Associés
/s/ Renaud Maxime Cambet
2 unchanged sentences
Paris-La Défense, France
−Removed: April 11, 2025
+Added: March 26, 2026
DBV Technologies S.A.
17 unchanged sentences
Short-term operating leases
−Removed: Current contingencies 13 122 3,959
+Added: Current contingencies & Employee Benefits
Other current liabilities
Total current liabilities 58,025 31,136
−Removed: Non-current liabilities:
Long-term operating leases
−Removed: Non-current contingencies 13 838 935
+Added: Non-current contingencies & Employee Benefits
Total non-current liabilities 6,923 7,135
3 unchanged sentences
235,670,864 and 102,847,501 shares authorized, and issued as at December 31, 2025 and December 31, 2024, respectively,
−Removed: $ 11,651 10,972
Additional paid-in capital
−Removed: Treasury stock, 266,868 and 222,988 and ordinary shares as of December 31, 2024 and December 31, 2023, respectively, at cost
−Removed: ( 1,309 ) ( 1,263 )
+Added: Treasury stock, 74,680 and 266,868 ordinary shares as of December 31, 2025 and December 31, 2024, respectively, at cost
Accumulated deficit
3 unchanged sentences
Total Liabilities and Shareholder's equity 10
+Added: $ 233,718 65,658
The accompanying notes are an integral part of these consolidated financial statements.
3 unchanged sentences
Twelve Months Ended December 31,
+Added: Notes 2025 2024
Operating income
4 unchanged sentences
Total Operating expenses 14
+Added: ( 152,692 ) ( 120,740 )
Loss from operations
1 unchanged sentence
Loss before taxes
−Removed: Income tax ( 55 ) ( 7 )
−Removed: Net loss $ ( 113,918 ) ( 72,726 )
Foreign currency translation differences, net of taxes
1 unchanged sentence
Comprehensive loss $
+Added: ( 140,185 ) ( 117,977 )
Basic/diluted Net loss per share attributable to shareholders
10 unchanged sentences
Depreciation, amortization and accrued contingencies
−Removed: Retirement pension obligations — 76
Expenses related to share-based payments
+Added: Inventory write-downs
Other elements
Changes in operating assets and liabilities:
+Added: Decrease (increase) in inventories and work in progress
Decrease (increase) in other current assets
(Decrease) increase in trade payables
−Removed: (Decrease) increase in other current liabilities 366 ( 5,334 )
+Added: (Decrease) increase in other current and non-current liabilities
Change in operating lease liabilities and right of use assets
3 unchanged sentences
Change in intangible assets
−Removed: Change in non-current assets 1,584 ( 131 )
+Added: Change in non-current other assets
Net cash flows used in investing activities ( 1,369 ) ( 757 )
7 unchanged sentences
Net cash and cash equivalents at the end of the period $ 194,167 32,456
+Added: The Company now presents inventory write-downs separately from the “Decrease (Increase) in inventories and work in progress” line item.
+Added: Comparative information has been updated accordingly to ensure consistency.
The accompanying notes are an integral part of these consolidated financial statements.
6 unchanged sentences
96,431,770 10,972 377,468 ( 1,263 ) ( 238,862 ) 742 ( 8,871 ) 140,187
−Removed: Net (loss) — ( 72,726 ) ( 72,726 )
Other comprehensive income (loss)
Issuance of ordinary shares
+Added: Issuance of warrants 6,010,000
Treasury shares
1 unchanged sentence
Allocation of accumulated net losses
+Added: Other change in equity
+Added: — ( 28 ) ( 4 ) ( 32 )
Balance at December 31, 2024
102,847,501 11,651 315,613 ( 1,309 ) ( 286,375 ) 905 ( 13,097 ) 27,387
−Removed: Net (loss) — ( 113,918 ) ( 113,918 )
Other comprehensive income (loss)
Issuance of ordinary shares
−Removed: Exercised share warrants 6,010,000 636 636
+Added: Issuance of warrants 70,053
Treasury shares
8 unchanged sentences
Incorporated in 2002 under the laws of France, DBV Technologies S.A.
−Removed: (“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™.
−Removed: The Company’s therapeutic approach is based on epicutaneous immunotherapy, or EPITTM, a proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin™.
+Added: (“DBV Technologies,” or the “Company”, or “we”, or the “group”) is a late-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin.
+Added: The Company’s therapeutic approach is based on EPIT, a proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin.
Basis of Presentation
8 unchanged sentences
The categories concerned are detailed in the following notes.
+Added: Recently Adopted Accounting Pronouncements
+Added: In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740):
+Added: Improvements to Income Tax Disclosures, which enhances transparency by requiring additional disclosures related to income taxes.
+Added: The amendments primarily require:
+Added: • A tabular reconciliation of the effective tax rate to the statutory rate, including both dollar amounts and percentages, with separate disclosure of items that are equal to or greater than 5% of the statutory rate.
+Added: • Disaggregation of income taxes paid between federal, state, and foreign jurisdictions, and identification of any individual jurisdiction that accounts for 5% or more of total income taxes paid.
+Added: The guidance is effective for annual periods beginning after December 15, 2024, with early adoption permitted.
+Added: The Company applied the ASU retrospectively by providing the revised disclosures for the year ended December 31, 2024.
+Added: Accounting Pronouncements issued not yet adopted
+Added: In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income Topic 220 — Expense Disaggregation Disclosures.
+Added: The guidance requires disclosure of additional information about specific expense categories in the notes to financial statements at interim and annual reporting periods.
+Added: The disclosure requirements will be applied on a prospective basis, with the option to apply it retrospectively.
+Added: For SEC filers, this ASU is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027.
+Added: Management evaluated the impact of adopting ASU 2024‑03 and determined that its adoption will result on expanded disclosures on the Company’s consolidated financial statements.
+Added: In December 2025, the FASB issued ASU 2025‑12, Codification Improvements, which includes a series of technical corrections, clarifications, and minor improvements to existing guidance across various Topics in the FASB Accounting Standards Codification.
+Added: The amendments are not expected to significantly affect current accounting practices.
+Added: ASU 2025‑12 is effective for annual and interim reporting periods beginning after December 15, 2026.
+Added: The Company does not expect the adoption of this ASU to have a material impact on its consolidated financial statements.
+Added: In December 2025, the FASB also issued ASU 2025‑11, Interim Reporting (Topic 270):
+Added: Narrow‑Scope Improvements, which clarifies the scope and applicability of interim reporting guidance, enhances the organization and navigability of required interim disclosures, and introduces a disclosure principle requiring entities to disclose material events or changes that occur after the most recent annual reporting period.
+Added: For public business entities, the ASU is effective for interim reporting periods in fiscal years beginning after December 15, 2027.
+Added: Early adoption is permitted.
+Added: The Company is currently evaluating the impact of this ASU on its interim reporting disclosures and does not expect it to have a material impact on its consolidated financial statements.
+Added: In December 2025, the FASB issued ASU 2025‑10, Government Grants (Topic 832):
+Added: Accounting for Government Grants Received by Business Entities, which establishes authoritative U.S.
+Added: GAAP guidance for the recognition, measurement, presentation, and disclosure of government grants received by business entities.
+Added: The amendments are effective for public business entities for annual reporting periods beginning after December 15, 2028, including interim periods within those annual periods, with early adoption permitted.
+Added: The Company is evaluating the potential impact of adopting this guidance on its consolidated financial statements.
+Added: However, it does not expect a material impact.
+Added: 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.
+Added: Use of estimates
+Added: 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.
+Added: The estimates and assumptions, developed based on the information available at the time of closing the accounts, particularly relate to:
+Added: • The assessment of the fair value of equity-settled share-based compensation plans granted to employees and/or executives, which is performed using actuarial models.
+Added: These models require the Company to use certain calculation assumptions, such as the expected volatility of the share price and the estimated timing of achieving performance conditions over the vesting period of the share-based compensation plan ;
+Added: • The evaluation of the amount of the Research Tax Credit, which is based on eligible internal and external research expenses incurred by the Company during the fiscal year.
+Added: Only eligible research expenditures are included in the calculation of the Research Tax Credit;
+Added: • The recoverability of the Company’s net deferred tax assets and related valuation allowance
+Added: • The assumptions used in the valuation of right-of-use assets & operating leases
+Added: • The estimate of provisions and contingencies.
+Added: The final amounts may differ from these estimates.
+Added: Management is also required to exercise judgment in the following areas:
+Added: Going concern
+Added: These Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern.
+Added: The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business for at least twelve months as of date of issuance of the Financial statements.
+Added: The Company has incurred operating losses and negative cash flows from operations since inception.
+Added: The Company does not generate revenue and continues to prepare for the potential launch of its first product in the United States and in the European Union, if approved.
+Added: In April 2025, the Company completed a PIPE financing generating initial gross proceeds of $ 125.5 million (€ 116.3 million), followed by the full exercise of associated warrants in January 2026 after the announcement of positive Phase 3 VITESSE topline results, resulting in additional gross proceeds of $ 195.0 million (€ 166.7 million).
+Added: In addition, in September 2025, the Company established an ATM equity program pursuant to which it may offer and sell up to $ 150.0 million of ADSs, subject to applicable regulatory limits.
+Added: During the fourth quarter of 2025, the Company raised $ 65 million in gross proceeds through multiple issuances of ADSs.
+Added: As a result of the proceeds received from the subsequent exercise of the ABSA and BS warrants of $ 94 million (€ 81 million) and with existing cash and cash equivalents as of December 31, 2025 of $ 194 million, management has determined that the Company has sufficient liquidity to fund its operations for at least twelve months from the date of issuance of this Form 10‑K and that the conditions that previously raised substantial doubt about the Company’s ability to continue as a going concern are no longer present.
+Added: With the receipt of the aforementioned proceeds, and based on its current operations, plans, and assumptions, the Company estimates that its cash and cash equivalents are sufficient to fund its operations into the second quarter of 2027.
+Added: These estimates are based on the Company’s current forecasts and exclude any additional expenditures related to other programs than the VIASKIN® Peanut or resulting from the potential in licensing or acquisition of additional product candidates or technologies, or any associated development the Company may pursue.
+Added: The Company may have based these estimates on assumptions that are incorrect, and the Company may end up using its resources sooner than anticipated.
+Added: Significant contracts
+Added: March 2025 PIPE Financing
+Added: Financing Milestones
+Added: On March 27, 2025, the Company announced the 2025 PIPE financing, to advance the VIASKIN Peanut patch through BLA submission and U.S.
+Added: commercial launch, if approved.
+Added: The financing included gross proceeds of $ 125.5 million (€ 116.3 million) received on April 7, 2025, and up to $ 181.4 million (€ 168.2 million at the exchange rate of 1 EUR = $ 1.08 ) in potential additional gross proceeds contingent to the full exercise of all the warrants, subject to satisfaction of specified conditions.
+Added: The VITESSE Phase 3 study hitting its primary endpoint will trigger an acceleration of the exercise period of some of the warrants.
+Added: The ABSA Warrants (defined below) will be exercisable from their respective date of issue until the earlier of (i) April 7, 2027 and (ii) 30 days following the publication by the Company of a press release announcing that the ongoing VITESSE trial of the VIASKIN® Peanut patch in children 4-7 years old met the primary endpoint defined in the VITESSE study protocol (the "Vitesse Topline Results").
+Added: It being specified that (i) the primary measure of treatment effect will be the difference in response rates at Month 12 between active and placebo treatment groups, (ii) the primary analysis will be based on a 2-sided confidence interval (“CI”) for the difference in response rates, and (iii) the primary analysis must be positive according to the success criterion (lower bound of the 2- sided 95 % CI of the difference in response rates ≥ 15 %) (the “ABSA Warrant Exercise Period”).
+Added: Following the announcement of the positive VITESSE Topline Results on December 16, 2025, the ABSA Warrants and BS Warrants were exercisable until January 16, 2026.
+Added: On January 16, 2026, the Company announced additional gross proceeds of € 166.7 million resulting from the full exercise of (i) 34,090,004 warrants attached to the ABSA Warrants (as defined below) resulting in the issuance of 59,657,507 new ordinary shares of the Company (as defined below) and (ii) 71,005,656 BS Warrants (as defined below) resulting in the issuance of 71,005,656 Second Pre-Funded Warrants (as defined below), allowing its holders to subscribe for an aggregate of up to 124,259,898 new shares.
+Added: On January 16, 2026, the Company announced additional gross proceeds of $ 195.0 million (€ 166.7 million at the exchange rate of 1 EUR = $ 1.17 ) resulting from the full exercise of the ABSA Warrants and BS Warrants, following the announcement of the positive VITESSE Topline Results on December 16, 2025.
+Added: Of these proceeds, $ 100.7 million in gross proceeds (€ 85.7 million, at the exchange rate of 1 EUR = $ 1.17 ) was received as of December 31, 2025, with the remaining amount received in January 2026.
+Added: Reminder of the main characteristics of the financing
+Added: The exercise of one (1) ABSA Warrant gives the holder the right to subscribe to one point seventy-five ( 1.75 ) ABSA Warrant Shares at a price of € 1.5939 per ABSA Warrant.
+Added: The financing resulted in an immediate dilution of 22.4 % and a maximal dilution of up to 73.7 % of existing shareholders (on a non-diluted basis) if all the warrants in the Offering are exercised in full.
+Added: The financing consisted of:
+Added: • a share capital increase without preferential subscription rights reserved to categories of persons satisfying determined characteristics pursuant to the 24th resolution of the 2024 General Meeting completed on April 7, 2025 for an amount of $ 41 million (€ 38 million), consisting of the issuance of (i) 34,090,004 new shares at a par value of € 0.10 (the "New Shares") each with warrants of the Company attached (the "ABSA Warrants", and together with the New Shares, the "ABSA") at a subscription price of € 1.1136 per ABSA and (ii) up to 59,657,507 additional new shares, if all the ABSA Warrants attached to the New Shares are exercised (the "ABSA Warrant Shares");
+Added: • and the issue through an offering reserved to categories of persons satisfying determined characteristics of 71,005,656 units (the “PFW-BS-PFW”) completed on April 7, 2025 for an amount of $ 85 million (€ 79 million) at a subscription price of € 1.1136 per PFW-BS-PFW (of which € 1.1036 will have been prefunded on the issue date), each PFW-BS-PFW consisting of one pre-funded warrant to subscribe for one share of the Company (the "First Pre-Funded Warrants") and one warrant (the "BS Warrants") to subscribe to one second pre-funded warrants (the "Second Pre-Funded Warrants"), each of which entitles the holder to subscribe for 1.75 shares of the Company (the "Second PFW Shares"), allowing to issue up to 71,005,656 additional new shares if all the First Pre-Funded Warrants are exercised (the "First PFW Shares") and up to 124,259,898 additional new shares if all the Second Pre-Funded Warrants are exercised (the "Second PFW Shares", together with the ABSA Warrant Shares and the First Pre-Funded Warrant Shares, the "Warrant Shares", and together with the New Shares, the "Offered Shares"),(together, the "Offering").
+Added: Use of proceeds
+Added: The proceeds from the issue of the ABSA Warrants and BS Warrants, together with existing cash and cash equivalents, will be mainly used (i) for working capital and general corporate purposes, (ii) to finance the preparation and submission of a potential Biologics License Application (BLA) as well as (iii) efforts to support, the readiness of the potential launch of VIASKIN® Peanut for children aged 4-7 years in the US, if approved.
+Added: Accounting treatment
+Added: To properly account for pre-funded warrants under US GAAP, an issuer must first apply ASC 480 – Distinguishing liabilities from equity, and then from ASC 815 – Derivatives and Hedging ASC 480 – DISTINGUISHING LIABILITIES FROM EQUITY
+Added: Under ASC 480–10–25, a financial instrument should be classified as liability if:
+Added: (i) It is mandatorily redeemable,
+Added: (ii) It represents an unconditional obligation to repurchase the issuer’s equity shares,
+Added: (iii) It requires the issuer to deliver a variable number of shares or net cash settlement.
+Added: In our view, April 2025 prefunded warrants avoid all ASC 480 triggers as they meet the following conditions:
+Added: (i) Freestanding and detachable:
+Added: they are legally separable from other instruments,
+Added: (ii) Fixed exercise terms:
+Added: they entitle the holder to a fixed number of shares upon exercise,
+Added: (iii) No redemption obligations:
+Added: they do not require the issuer to transfer cash to repurchase shares.
+Added: ASC 815 – DERIVATIVES AND HEDGING
+Added: ASC 815 – 40 – Contracts in Entity’s Own Equity addresses whether an equity-linked contract, qualifies as equity in the entity’s financial statements.
+Added: Indexation to the Company’s own stock.
+Added: The first condition that must be met for an equity-linked instrument to qualify as equity is to be considered indexed to the entity’s own stock in accordance with ASC 815-40-15.
+Added: To determine whether an equity-linked instrument is indexed to the Entity’s own stock, a 2-step analysis must be performed:
+Added: • Step 1 – Evaluate whether the instrument contains any exercise contingencies, and, if so, whether they disqualify the instrument from being classified as equity,
+Added: • Step 2 – Assess whether the settlement terms are consistent with equity classification.
+Added: Based on the above elements Prefunded warrants are to be indexed to the Company’s stock.
+Added: Equity classification
+Added: As Pre-Funded warrants require a settlement in shares (physical settlement) and neither give rise to a net-cash settlement nor provide the option of settlement in shares or net cash settlement, they shall be initially classified as equity.
+Added: Other conditions necessary for equity classification are met:
+Added: • The Company has sufficient authorized and unissued shares available to settle the contract after considering all other commitments that may require the issuance of stock during the maximum period the Pre-Funded warrants could remain outstanding.
+Added: • The contract contains an explicit limit on the number of shares ( 1 share per First Pre-Funded warrant and up to 71,005,656 in total and 1.75 share per Second Prefunded warrant and up to 124,259,898 in total) to be delivered in a share settlement.
+Added: Adjustments to the exercise ratio are subject to the occurrence of specific events and result from the application of determined formulas.
+Added: • There is no required cash payment if DBV Technologies S.A.
+Added: fails to timely file.
+Added: There is no requirement to net cash settle the contract in the event the entity fails to make timely filings with the SEC or to maintain registration.
+Added: • There are no cash settled top-off or make-whole provisions.
+Added: April 2025 Prefunded warrants can be classified as equity and shall be accounted for in permanent equity.
+Added: Subsequent changes in fair value shall not be recognized as long as they continue to be classified as equity.
+Added: Upon exercise of the pre-funded warrants, the Company issued common shares in accordance with the terms of the warrants.
+Added: The accounting treatment for the exercise is as follows:
+Added: • The par value of the newly issued common shares is recorded in ‘Common stock’.
+Added: Any additional amount, including the exercise price paid and the remaining carrying amount of the warrants is recorded in ‘Additional paid‑in capital.
+Added: • No gain or loss was recognized in the Consolidated Statements of Operations and Comprehensive Loss as the warrants were classified as equity from inception.
+Added: • The Company updated its share count and equity roll-forward to reflect the issuance of shares.
+Added: Manufacturing Supply Agreement - PSM “Peanut Source Material “ Fareva La Vallée
+Added: On March 17, 2026, DBV Technologies S.A.
+Added: entered into the MS Agreement with FLV, under which FLV will manufacture and supply the PSM, exclusively for DBV Technologies S.A.
+Added: during the agreement term.
+Added: The term is effective for a period of eight ( 8 ) years and can be renewed for a period of two ( 2 ) years.
+Added: This contract is subsequent to the initial PSM Service Agreement entered into on March 18, 2024 by the Company and FLV for the construction of a dedicated facility (PSM Facility) and the transfer of manufacturing of the PSM required to produce Viaskin Peanut patches.
+Added: This contract also included binding commercial terms which were incorporated into the MS Agreement.
+Added: The PSM Services Agreement services include (i) construction activities, (ii) the acquisition equipment, and (iii) the cGMP qualification of a dedicated PSM production line installed at FLV’s premises.
+Added: DBV has funded capital expenditures amounting to $ 3.9 million, granting access to preferential pricing and to an exclusively dedicated PSM production line located at FLV’s facilities, while ownership of the line remains with FLV.
+Added: The assessment of the Master Supply Agreement concludes that the arrangement contains an embedded lease within the scope of ASC 842 (Leases), based on the following criteria:
+Added: – Identified asset:
+Added: The dedicated PSM production line represents an identified asset, and the supplier does not have substitution rights.
+Added: – Control of use:
+Added: The Company has (i) the right to obtain substantially all of the economic benefits from use of the asset, through exclusive access to the production capacity, and (ii) the right to direct the use of the asset, including decision‑making authority over relevant activities such as production volumes, scheduling, and operating methods.
+Added: In accordance with ASC 842‑10‑25‑2, the right‑of‑use asset will be recognized at the lease commencement date, defined as the date on which the production line is made available for use following completion of cGMP qualification.
+Added: As the lease commencement date occurs in 2026, no recognition or reclassification is required for FY2025.
+Added: The disclosure has therefore been limited to describing the accounting treatment upon commencement.
+Added: In accordance with ASC 855 (Subsequent Events), the year‑end assessment is limited to the identification of the embedded lease, the separation of lease and non‑lease components of the arrangement, and the reclassification of the payment related to the exclusive access right as prepaid rent under ASC 842.
+Added: The Company has non-cancellable minimum commitments for PSM, subject to the terms of the MS Agreement.
+Added: At the end of a 36-month period starting from the first commercial batch delivery, if the Company has not ordered any batches, excluding technical and validation batches, the Company shall pay FLV an amount not to exceed $ 0.6 million .
+Added: Significant Accounting Policies
Principles of Consolidation
3 unchanged sentences
• DBV Technologies Inc.
−Removed: was incorporated in Delaware on April 7, 2014 (the “US subsidiary”).
−Removed: The share capital of this US subsidiary is 100 % owned by DBV Technologies S.A.;
+Added: was incorporated in Delaware on April 7, 2014 (the “U.S.
+Added: subsidiary”).
+Added: The share capital of this U.S.
+Added: subsidiary is 100 % owned by DBV Technologies S.A.;
• DBV Australia Pty Ltd.
1 unchanged sentence
The share capital of this Australian subsidiary is 100 % owned by DBV Technologies S.A.;
−Removed: (“DBV Technologies”);
• DBV Pharma was incorporated in Paris on December 31, 2018 (the “French subsidiary”).
The share capital of this French subsidiary is 100 % owned by DBV Technologies S.A.
+Added: Foreign Currency Matters
Functional Currency and Translation of Financial Statements in Foreign Currency
7 unchanged sentences
The resulting exchange gains or losses are recorded in the Consolidated Statement of Operations and Comprehensive Loss in Operating income (expenses) or Financial income (expenses) depending on the nature of the underlying monetary item.
−Removed: Use of estimates
−Removed: 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.
−Removed: The Company bases its estimates and assumptions on historical experience and other factors that it believes to be reasonable under the circumstances.
−Removed: On an on-going basis, management evaluates its estimates, primarily those related to:
−Removed: (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.
−Removed: Going concern
−Removed: T hese Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern.
−Removed: The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business.
−Removed: The Company has incurred operating losses and negative cash flows from operations since inception.
−Removed: 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.
−Removed: Since its inception, the Company has primarily funded its operations through equity financings, as well as public assistance and Research Tax Credit.
−Removed: Prior to 2022, the Company underwent restructuring efforts, scaled down certain clinical programs, and engaged with regulatory authorities to advance Viaskin Peanut’s approval process in the United States and European Union.
−Removed: In 2022, the Company secured a private placement financing of $ 194 million and lifted a partial clinical hold from the FDA on its VITESSE Phase 3 clinical study.
−Removed: On April 7, 2025, the Company received gross proceeds of $ 125.5 million (€ 116.3 million) from the issuance of the ABSA and PFW-BS-PFW, as described in Note 20.
−Removed: With the receipt of the aforementioned proceeds, and based on its current operations, plans, and assumptions examined by the Board on March 23, 2025, the Company estimates that its cash and cash equivalents are sufficient to fund its operations into June 2026.
−Removed: Given the Company’s historical operating losses and reliance on external financings, the Company may still seek additional capital for future needs through a combination of public or private equity or debt financings, collaborations, licensing agreements, and other funding options.
−Removed: While recent financing events have improved the Company’s financial position, access to additional capital in the future remains subject to market conditions and investor interest.
Intangible Assets
3 unchanged sentences
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.
−Removed: Property, Plant, and Equipment
−Removed: Property, plant, and equipment are recorded at their acquisition cost.
−Removed: Property, plant, and equipment are depreciated on a straight-line method over the estimated useful lives of the property.
−Removed: Leasehold improvements are amortized over the shorter of the estimated useful lives of the assets or the remaining lease term.
−Removed: Depreciation is calculated on a straight-line basis over the assets’ estimated useful lives as follows:
−Removed: Property, plant, and equipment item period Depreciation
−Removed: Laboratory equipment and technical facilities 3 to 10 years
−Removed: Building fixtures and leasehold improvements 5 to 9 years
−Removed: Office equipment and furniture 5 years
−Removed: Computer equipment 3 years
−Removed: Impairment of assets
−Removed: 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.
−Removed: 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.
+Added: Research and Development Expenditures
+Added: Research and development expenditures are charged to expense as costs are incurred in performing research and development activities.
+Added: 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.
+Added: 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.
Lease contracts
11 unchanged sentences
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.
−Removed: Inventories and Work in Progress
−Removed: Inventories are measured at the lower of cost or net realizable value at production costs calculated using the first-in, first-out method.
−Removed: It includes acquisition costs, processing costs and other costs incurred in bringing the inventories to their present location and condition.
−Removed: Inventories are exclusively composed of work in progress relating to the production of the first batches that may be used for the commercialization.
−Removed: During the launch phase of a new product, any inventories of that product are written down to zero pending regulatory approval.
−Removed: Financial Assets and Liabilities
−Removed: Financial assets, excluding cash and cash equivalents, consist exclusively of other receivables.
−Removed: Other receivables are non-derivative financial assets with a payment, which is fixed or can be determined, not listed on an active market.
−Removed: They are included in current assets, except those that mature more than twelve months after the reporting date.
−Removed: 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.
−Removed: If the recoverable amount is lower than the carrying amount, an impairment loss is recognized in the Consolidated Statements of Operations and Comprehensive Loss.
−Removed: 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.
−Removed: The amount resulting from the deemed benefit of the interest-free nature of the award is considered a subsidy for accounting purposes.
−Removed: 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.
−Removed: 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.
−Removed: The adjustment that results therefrom is recognized in the income statement for the fiscal year during which the modification is recognized.
−Removed: The Company carries its trade receivable at net realizable value.
−Removed: 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.
−Removed: The Company generally does not require any security or collateral to support its receivables.
−Removed: During the years ended December 31, 2024 and December 31, 2023, the Company did not hold any derivative financial instruments.
+Added: Property, Plant, and Equipment
+Added: Property, plant, and equipment are recorded at their acquisition cost.
+Added: Property, plant, and equipment are depreciated on a straight-line method over the estimated useful lives of the property.
+Added: Leasehold improvements are amortized over the shorter of the estimated useful lives of the assets or the remaining lease term.
+Added: Depreciation is calculated on a straight-line basis over the assets’ estimated useful lives as follows:
+Added: Property, plant, and equipment item period Depreciation
+Added: Laboratory equipment and technical facilities
+Added: 3 to 10 years
+Added: Building fixtures and leasehold improvements
+Added: Office equipment and furniture
+Added: Computer equipment
+Added: Impairment of assets
+Added: 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.
+Added: 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.
+Added: Financial Instruments
+Added: The following section details the principles applicable to non-derivative and derivative financial instruments, with a focus on classification, measurement, and impairment.
+Added: Non-Derivative Financial Assets:
+Added: Classification and Measurement
+Added: Financial assets that are not derivatives are classified based on management’s intent and the asset’s characteristics.
+Added: The company has mainly deposits and receivables that are not securities that are typically measured at amortized cost, less any allowance for credit losses.
+Added: Non-Derivative Financial Liabilities:
+Added: Classification and Measurement
+Added: Financial liabilities that are not derivatives are initially recognized at fair value, net of transaction costs directly attributable to the issuance.
+Added: Subsequent measurement is generally at amortized cost using the effective interest method.
+Added: If a liability is designated as held for trading or accounted for under the fair value option (ASC 825), it is measured at fair value, with changes recognized in earnings.
+Added: Interest expense on financial liabilities is recognized in the income statement.
+Added: Derivative Financial Instruments:
+Added: Recognition and Measurement
+Added: All derivative instruments are recognized initially at fair value, with subsequent changes in fair value recognized in earnings unless the derivative qualifies for hedge accounting under ASC 815.
+Added: For qualifying hedges, the accounting treatment depends on the type of hedge (fair value, cash flow, or net investment).
+Added: Derivatives not designated as hedging instruments are measured at fair value with gains and losses reported in earnings, typically within other income or expense.
+Added: Transaction costs directly attributable to derivatives are expensed as incurred.
Fair Value Measurements
10 unchanged sentences
There were no transfers into or out of Level 1, 2, or 3 during the periods presented.
−Removed: 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.
+Added: Inventories and Work in Progress
+Added: Under ASC 330, Inventories are measured at the lower of cost or net realizable value, and any write-downs are permanent.
+Added: The cost of inventories includes:
+Added: • Acquisition costs of raw materials,
+Added: • Conversion costs (including services and indirect costs),
+Added: • Other costs incurred to bring the inventories to their present location and condition.
+Added: The Company applies the weighted average cost method at period-end for inventory valuation.
+Added: This approach calculates a weighted average cost of the items available at the end of each period, ensuring consistent valuation of production batches.
+Added: The Company also uses standard cost for analytical tracking and industrial management.
+Added: Variances between standard costs and actual costs, which flow through profit or loss, are analyzed and allocated to inventories when significant.
+Added: Inventories mainly consist of work in progress related to the production of initial batches intended for commercialization.
+Added: As the company is currently under Phase 3 of its clinical development and awaiting regulatory approvals, all pre-commercial inventories have been fully written down.
+Added: Reversals of inventory write-downs are prohibited, even if inventories are subsequently sold.
Cash and Cash Equivalents
3 unchanged sentences
Cash equivalents are measured at fair value using Level 1 and any changes are recognized in the Consolidated Statements of Operations and Comprehensive Loss.
−Removed: Concentration of Credit Risk
−Removed: The Company has no significant off-balance sheet risk, such as foreign currency contracts, options contracts, or other foreign hedging arrangements.
−Removed: Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and other receivables.
−Removed: Periodically, the Company maintains deposits in accredited financial institutions in excess of federally insured limits.
−Removed: The Company deposits its cash in financial institutions that it believes have high credit quality and have not experienced any losses on such accounts and does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships or entities for which it has a receivable.
Share Capital
1 unchanged sentence
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.
+Added: Share-based payments
+Added: In accordance with U.S.
+Added: GAAP, specifically ASC 718, Compensation—Stock Compensation, these awards are measured at their fair value on the date of grant.
+Added: 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 (vesting) period typically four years, with a corresponding increase in shareholders’ equity.
+Added: The expense measurement also takes into account the level of achievement of performance conditions, where applicable and on the legal interpretation of the RSUs award agreements with employees under the French labor laws and related jurisprudence.
+Added: Changes in interpretations could significantly impact on the accounting for the share-based payments.
+Added: 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.
+Added: The company has also established several plans for equity compensation issued in the form of “share warrants” (bons de souscription d’actions or “BSAs”) granted to non-employee members of the Board of Directors and members of the Scientific Advisory Board.
+Added: Stock Option Plans (“SO”)
+Added: The fair value of stock option plans is measured at the grant date using Black and Sholes models that require inputs based on certain subjective assumptions, including the expected term of the award, and the conditions of each equity plan.
+Added: The expense recognized reflects the estimated forfeiture rate of the options.
+Added: This expense is adjusted over the vesting period to reflect the actual forfeiture rate due to departures and the achievement of non-market performance criteria.
+Added: At each closing date, the Company reassesses the number of options expected to vest.
+Added: 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.
+Added: The awards are not subject to any market conditions.
+Added: Restricted Stock Unit Plans (“RSU”)
+Added: The fair value of the granted shares is based on the market price of the Company’s stock at the grant date.
+Added: Other conditions are considered in estimating the number of shares expected to vest during the vesting period, and this number is finally adjusted based on the actual number of shares vested at the vesting date.
+Added: Government grants and conditional advances
+Added: The Company benefits from various forms of government assistance, including grants and conditional advances.
+Added: In the absence of specific authoritative guidance under U.S.
+Added: GAAP applicable to for‑profit entities, the Company accounts for government grants by analogy to IAS 20 Accounting for Government Grants and Disclosure of Government Assistance , which management believes provides the most relevant and reliable accounting framework.
+Added: Government grants are recognized when there is reasonable assurance that:
+Added: • the Company will comply with the conditions attached to the grants;
+Added: • the grants will be received.
+Added: Non‑refundable grants are initially recorded as deferred income and are recognized in the statement of operations as “Other operating income” on a systematic basis over the period of the related research program to which the grants relate.
+Added: A government grant receivable that is intended either to compensate for expenses or losses already incurred, or to provide immediate financial support to the Company with no future related costs, is recognized in income in the period in which the receivable becomes earned and realizable.
+Added: Research Tax Credit specific considerations
+Added: 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.
+Added: 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.
+Added: The expenditures taken into account for the calculation of the Research Tax Credit involve only research expenses.
+Added: In the fiscal year ended December 31, 2021, the Company recovered its Small and Medium-sized Enterprises (“SMEs”) status under EU law, and became therefore eligible again for the immediate reimbursement of the Research Tax Credit.
+Added: Contingencies
+Added: An estimated loss from a loss contingency is recognized if the following two conditions are met:
+Added: • 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;
+Added: • the amount of loss can be reasonably estimated.
+Added: 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.
+Added: These judgment and estimates are subject to change as new information becomes available.
Employee benefits
11 unchanged sentences
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.
−Removed: Contingencies
−Removed: An estimated loss from a loss contingency is recognized if the following two conditions are met:
−Removed: • 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;
−Removed: • the amount of loss can be reasonably estimated.
−Removed: 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.
−Removed: These judgment and estimates are subject to change as new information becomes available.
−Removed: Operating Income
−Removed: 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.
−Removed: Other operating income
−Removed: Research Tax Credit
−Removed: 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.
−Removed: 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.
−Removed: The expenditures taken into account for the calculation of the Research Tax Credit.
−Removed: involve only research expenses.
−Removed: 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.
−Removed: During the year ended December 31, 2023, the Company received a reimbursement of $ 6.0 million for the 2022 fiscal year Research Tax Credit..
−Removed: During the year ended December 31, 2024, the Company received a reimbursement for the 2023 fiscal year Research Tax Credit.
−Removed: for a total amount of $ 8.7 million, included 2020, 2021 and 2022 complementary Research Tax Credit.
−Removed: made during the fiscal year ended December 31, 2023.
−Removed: Collaboration agreement with Nestlé Health Science
−Removed: The Company entered into research and development collaboration agreements that may consist of non-refundable upfront payments and milestone payments.
−Removed: Non-refundable upfront payments are deferred and recognized as income over the period of the collaboration agreement.
−Removed: Milestone payments represent amounts received depending upon the achievement of certain scientific, regulatory, or commercial milestones.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: The Company periodically updated its measurement of progress and updated its cumulative income recognized accordingly.
−Removed: 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.
−Removed: Please refer to Note 13 “Contingencies”.
−Removed: Research and Development Expenditures
−Removed: Research and development expenditures are charged to expense as costs are incurred in performing research and development activities.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: The Company records the related reimbursement of research and development costs under these agreements as income in the period in which such costs are incurred.
−Removed: Please refer to Collaboration agreement with Nestlé Health Science for further detail.
−Removed: Share-based payments
−Removed: 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.
−Removed: The company has also established several plans for equity compensation issued in the form of “share warrants” ( bons de souscription d’actions or “BSAs”) granted to non-employee members of the Board of Directors and members of the Scientific Advisory Board.
−Removed: These awards are measured at their fair value on the date of grant.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: Changes in interpretations could significantly impact the accounting for the share-based payments.
−Removed: At each closing date, the Company re-assesses the number of options expected to vest.
−Removed: 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.
−Removed: The awards are not subject to any market conditions.
Income taxes are accounted for under the asset and liability method of accounting.
+Added: Deferred Taxes
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.
9 unchanged sentences
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.
+Added: Income Tax Disclosures
+Added: In December 2023, the FASB issued ASU 2023 09, Income Taxes (Topic 740):
+Added: Improvements to Income Tax Disclosures, which enhances transparency by requiring additional disclosures related to income taxes.
+Added: The amendments primarily require:
+Added: • A tabular reconciliation of the effective tax rate to the statutory rate, including both dollar amounts and percentages, with separate disclosure of items that are equal to or greater than 5% of the statutory rate.
+Added: • Disaggregation of income taxes paid between federal, state, and foreign jurisdictions, and identification of any individual jurisdiction that accounts for 5% or more of total income taxes paid.
+Added: The Company applied the ASU retrospectively by providing the revised disclosures for the year ended December 31, 2024.
+Added: As a French listed company, DBV determined its statutory tax rate based on its country of domicile, France [Domestic], which has a corporate income tax rate of 25%.
+Added: In accordance with the income tax rate reconciliation and disaggregation requirements of ASU 2023‑09, the Company evaluates income taxes paid by jurisdiction rather than solely by domicile.
+Added: Pursuant to the Company’s transfer pricing arrangements, DBV incurred and paid U.S.
+Added: income taxes representing 100% of total income taxes paid for fiscal year 2024.
+Added: Accordingly, the United States is presented as a separate significant jurisdiction.
+Added: Income taxes paid in other foreign jurisdictions are aggregated within the “Foreign” category, with Australia comprising the remaining foreign taxes paid.
Segment Information
11 unchanged sentences
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.
−Removed: The Company has evaluated subsequent events from the balance sheet date through April 11, 2025, the date at which the consolidated financial statements are issued.
−Removed: Accounting Pronouncements adopted in 2024
−Removed: In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280) — Improvements to Reportable Segment Disclosures, which enables investors to better understand an entity's overall performance and assists with assessing potential future cash flows.
−Removed: ASU 2023-07 expands public entities’ segment disclosures by requiring disclosure of significant segment expenses that are regularly provided to the Chief Operating Decision Maker (CODM) and included in the reported measure of segment profit and loss.
−Removed: The Company adopted ASU 2023-07 in December 2024.
−Removed: Refer to Note 21 - Reportable Segment Disclosure for further information.
−Removed: Accounting Pronouncements issued not yet adopted
−Removed: In December 2023, the FASB issued ASU 2023-09, Income Taxes Topic 740 — Improvements to Income Tax Disclosures which enhances the transparency and usefulness of income tax disclosures.
−Removed: This amendment requires disclosure of disaggregated information about the Company’s effective tax rate reconciliation as well as information on income taxes paid.
−Removed: The disclosure requirements will be applied on a prospective basis, with the option to apply it retrospectively.
−Removed: For SEC filers, this ASU is effective for fiscal years beginning after December 15, 2024.
−Removed: The Company is currently evaluating the impact the adoption of this ASU will have on its consolidated financial statements and related disclosures.
−Removed: In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income Topic 220 — Expense Disaggregation Disclosures.
−Removed: The guidance requires disclosure of additional information about specific expense categories in the notes to financial statements at interim and annual reporting periods.
−Removed: The disclosure requirements will be applied on a prospective basis, with the option to apply it retrospectively.
−Removed: For SEC filers, this ASU is effective for fiscal years beginning after December 15, 2026 and interim periods within fiscal years beginning after December 15, 2027.
−Removed: The Company is currently evaluating the impact the adoption of this ASU will have on its consolidated financial statements and related disclosures.
−Removed: 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.
−Removed: Note 2 Significant Events and Transactions of the Periods
−Removed: Clinical programs
−Removed: United States Regulatory History and Current Status
−Removed: 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.
−Removed: The FDA agreed with its position that a modified Viaskin Peanut patch should not be considered as a new product entity provided the occlusion chamber of the current Viaskin Peanut patch and the peanut protein dose of 250 μg (approximately 1/1,000 of one peanut) remains unchanged and performs in the same way it has performed previously.
−Removed: 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.
−Removed: The Company named that assessment EQUAL, which stands for Equivalence in Uptake of Allergen.
−Removed: The FDA also recommended conducting a six-month , well-controlled safety and adhesion trial to assess a modified Viaskin Peanut patch in the intended patient population.
−Removed: The Company later named this clinical trial STAMP, which stands for Safety, Tolerability, and Adhesion of Modified Patches.
−Removed: Based on the January 2021 FDA feedback, the Company defined three parallel workstreams:
−Removed: Identify a modified Viaskin patch (which the Company calls mVP).
−Removed: Generate the six-month safety and adhesion clinical data FDA requested via STAMP, which the Company expected to be the longest component of the mVP clinical plan.
−Removed: The Company prioritized the STAMP protocol submission so the Company could begin the clinical trial as soon as possible.
−Removed: Demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population via EQUAL.
−Removed: The complexity of EQUAL hinged on the lack of established clinical and regulatory criteria to characterize allergen uptake via an epicutaneous patch.
−Removed: 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:
−Removed: 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.
−Removed: The data collection phase of the trial is complete, and the data analysis phase is ongoing;
−Removed: “EQUAL in adults”—a second Phase 1 trial with adult healthy volunteers to compare the allergen uptake of cVP and mVP.
−Removed: 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.
−Removed: The Company completed CHAMP in the second quarter of 2021.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: In this letter, the FDA requested a stepwise approach to the modified Viaskin patch development program and provided partial feedback on the STAMP protocol.
−Removed: 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.
−Removed: The FDA’s explanation was that the results from the allergen uptake studies might affect the design of the STAMP study.
−Removed: 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.
−Removed: The Company estimated that the FDA’s newly proposed
−Removed: sequential approach would require at least five rounds of exchanges that necessitate FDA alignment prior to initiating STAMP, the six-month safety and adhesion study.
−Removed: 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.
−Removed: The Company considers this approach the most straightforward to potentially demonstrate effectiveness, safety, and improved in vivo adhesion of the modified Viaskin Peanut system.
−Removed: The FDA confirmed the Company’s change in strategy was agreeable via oral and written exchanges.
−Removed: 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.
−Removed: 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.
−Removed: The objective of EVOLVE was to evaluate the Instructions for Use (IFU) and ease of use for the mVP patch.
−Removed: The study concluded that the updated IFU supported correct patch application, which included no lifting of the patch edges or detachment directly after application.
−Removed: Furthermore, EVOLVE concluded that the majority of parents/caregivers reported a positive ease of use experience with the mVP patch.
−Removed: 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.
−Removed: EVOLVE verified that the eDiary tool can be used by caregivers in VITESSE to capture the adhesion data in support of a potential BLA.
−Removed: On March 7, 2023, the Company announced that the first patient was screened in the VITESSE study.
−Removed: Screening of the last patient is anticipated by Q3 2024.
−Removed: 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.
−Removed: The FDA requires additional safety data to augment the safety data collected from EPITOPE in support of a BLA.
−Removed: This new safety study will also generate patch adhesion data and will include updated instructions for use.
−Removed: On July 31, 2023, the Company announced receipt of feedback from FDA on the two supplemental safety studies, COMFORT Children and COMFORT Toddlers.
−Removed: 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.
−Removed: FDA agreed with a six-month study duration and a 3 :1 randomization (active:
−Removed: placebo) of approximately 400 subjects in the double-blind, placebo-controlled COMFORT Toddlers study.
−Removed: On March 24, 2025, the Company announced that in a Written Responses Only to the Company’s Type D IND meeting the FDA agreed with the Company’s proposal that the safety exposure data from the VITESSE Phase 3 study for Viaskin peanut patch in 4 – 7-year-olds will be sufficient to support a BLA filing in this age group.
−Removed: As a result, the COMFORT Children supplemental safety study will no longer be required and the Company will not conduct the study.
−Removed: The Company will utilize the safety data from the VITESSE participants randomized to active treatment as well as placebo-crossover participants in the VITESSE Open Label Extension (OLE).
−Removed: Accordingly, the Company plans to submit a BLA in the first half of 2026 and anticipates potentially accelerating the product launch by approximately one year, subject to FDA approval.
−Removed: Viaskin Peanut for children ages 4-11—European Union Regulatory History and Current Status
−Removed: 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.
−Removed: It is a letter that is meant to include any remaining questions or objections at that stage in the process.
−Removed: The EMA indicated many of their objections and major objections from the Day 120 list of questions had been answered.
−Removed: One major objection remained at Day 180.
−Removed: The Major Objection questioned the limitations of the data, for example, the clinical relevance and effect size supported by a single pivotal study.
−Removed: On December 20, 2021, the Company announced it withdrew the MAA for Viaskin Peanut and formally notified the EMA of our decision.
−Removed: The initial filing was supported by data from a single, placebo-controlled Phase 3 pivotal trial known as PEPITES (V712-301).
−Removed: 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.
−Removed: 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.
−Removed: The Company intend to resubmit the MAA when that data set is available.
−Removed: Viaskin Peanut for Children ages 1-3
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: Enrollment of Part B of EPITOPE was complete in first quarter of 2021.
−Removed: 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.
−Removed: Enrollment was balanced for age and baseline disease characteristics between the active and placebo treatment arms.
−Removed: 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.
−Removed: 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.
−Removed: This safety study will increase the safety data collected from EPITOPE in support of a BLA.
−Removed: It will also generate patch adhesion data and will include updated instructions for use.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: In November 2023, the Company announced the interim analyses from the first year of the open-label extension of EPITOPE.
−Removed: These data were presented at the annual American College of Allergy, Asthma and Immunology (ACAAI) in November 2023.
−Removed: Viaskin Peanut for Children ages 4-7
−Removed: 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.
−Removed: 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.
−Removed: On September 21, 2022, we announced we had received feedback from the FDA in the form of a partial clinical hold on VITESSE.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: On December 23, 2022, we announced the FDA lifted the partial clinical hold and confirmed we satisfactorily addressed all clinical hold issues.
−Removed: The FDA stated that VITESSE may proceed with the revised trial protocol.
−Removed: On March 7, 2023, the Company announced screening of the first patient in VITESSE.
−Removed: On September 23, 2024, the Company announced having exceeded its recruitment goal and successfully closed the screening process for the VITESSE Phase 3 study evaluating the Viaskin Peanut Patch in peanut allergic children ages 4 – 7 years old.
−Removed: Topline results of VITESSE data are expected in the fourth quarter 2025.
−Removed: On March 24, 2025, the Company announced that in a Written Responses Only to the Company’s Type D IND meeting the FDA agreed with the Company’s proposal that the safety exposure data from the VITESSE Phase 3 study for Viaskin peanut patch in 4 – 7-year-olds will be sufficient to support a BLA filing in this age group.
−Removed: As a result, the COMFORT Children supplemental safety study will no longer be required and the Company will not conduct the study.
−Removed: The Company will utilize the safety data from the VITESSE participants randomized to active treatment as well as placebo-crossover participants in the VITESSE Open Label Extension (OLE).
−Removed: Accordingly, the Company plans to submit a BLA in the first half of 2026 and anticipates potentially accelerating the product launch by approximately one year, subject to FDA approval.
−Removed: Diagnostic Tool Development
−Removed: On October 30, 2023, the Company and NESTEC entered into a Mutual Termination Letter Agreement terminating the Collaboration Agreement.
−Removed: Each party remains responsible for its own costs and expenses related to its respective wind –down activities.
−Removed: 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.
−Removed: Consequently, since signing the Mutual Termination Letter Agreement and as of December 31, 2023, we recorded the following:
−Removed: – Loss on completion accrual reversal $ 19.9 million (Other Operating Income);
−Removed: – Deferred revenue accrual reversal $ 6.9 million (Operating Expenses);
−Removed: – Accrual for ongoing Clinical study completion $ 2.3 million (Operating Expenses).
−Removed: This accrual represented our best estimate of the remaining expenses related to the ongoing clinical study which will be incurred after December 31, 2023 and until the end of the study.
−Removed: In May 2022, the Company announced that pursuant to the Company’s At-The-Market program established in May 2022 (the “ATM Program”), it had issued and completed sales of new ordinary shares (the “Ordinary Shares”) in form of American Depositary Shares (“ADSs”), for a total gross amount of $ 15.3 million ($ 14.1 million net of transaction costs).
−Removed: In this context, 6,036,238 new Ordinary Shares in form of ADS have been issued through a capital increase without preferential subscription rights of the shareholders reserved to specific categories of persons fulfilling certain characteristics (the “ATM Issuance”), at a unit subscription price of 1.27 dollar per ADS (i.e., a subscription price per Ordinary Share of € 2.41 based on the USD/EUR exchange rate of 1.0531 dollar for 1 euro, as published by the European Central Bank on May 4, 2022) and each ADS giving the right to receive one-half of one ordinary share of the Company.
−Removed: Pursuant to the ATM program, the Company issued and completed sales of new Ordinary Shares in the form of ADSs for a total gross amount of $ 7.8 million on June 14, 2023 (and a net amount of $ 6.9 million after $ 0.9 million capital increase fees imputation).
−Removed: 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 PIPE”).
−Removed: 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.
−Removed: Gross proceeds from the June 2022 PIPE total approximately $ 194 million (corresponding to € 181 million), before deducting private placement expenses.
−Removed: The ordinary shares issued in the June 2022 PIPE, including the ordinary shares issuable upon exercise of the pre-funded warrants from the PIPE financing, were not been registered under the Securities Act of 1933, as amended, at the time of the offering, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements.
−Removed: 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.
+Added: The Company has evaluated subsequent events from the balance sheet date through the issuance date of this report.
+Added: Note 2 Significant Events and Transactions of the Period
+Added: March 2025 PIPE Financing
+Added: The Company raised proceeds in the 2025 PIPE consisting of i) a share capital increase without preferential subscription rights reserved to categories of persons satisfying determined characteristics pursuant to the 24th resolution of the 2024 General Meeting completed on April 7 2025, for an amount of € 38 million ($ 41 million), consisting of the issuance of (i) 34,090,004 new shares at a par value of € 0.10 (the "New Shares") each with warrants of the Company attached (the "ABSA Warrants", and together with the New Shares, the "ABSA") at a subscription price of € 1.1136 per ABSA and (ii) up to 59,657,507 additional new shares, if all the ABSA Warrants attached to the New Shares are exercised (the "ABSA Warrant Shares");
+Added: and ii) the issue through an offering reserved to categories of persons satisfying determined characteristics of 71,005,656 units (the “PFW-BS-PFW”) completed on April 7, 2025 for an amount of € 79 million ($ 85 million) at a subscription price of € 1.1136 per PFW-BS-PFW (of which € 1.1036 will have been prefunded on the issue date), each PFW-BS-PFW consisting of one pre-funded warrant to subscribe for one share of the Company (the "First Pre-Funded Warrants") and one warrant (the "BS Warrants") to subscribe to one second pre-funded warrants (the "Second Pre-Funded Warrants"), each of which entitles the holder to subscribe for 1.75 shares of the Company (the "Second PFW Shares"), allowing to issue up to 71,005,656 additional new shares if all the First Pre-Funded Warrants are exercised (the "First PFW Shares") and up to 124,259,898 additional new shares if all the Second Pre-Funded Warrants are exercised (the "Second PFW Shares", together with the ABSA Warrant Shares and the First Pre-Funded Warrant Shares, the "Warrant Shares", and together with the New Shares, the "Offered Shares").
+Added: The Company received initial gross proceeds of $ 125.5 million (€ 116.3 million) on April 7, 2025.
+Added: On January 16, 2026, the Company announced additional gross proceeds of $ 195.0 million (€ 166.7 million at the exchange rate of 1 EUR = $ 1.17 ) resulting from the full exercise of the ABSA Warrants and BS Warrants, following the announcement of the positive VITESSE Topline Results on December 16, 2025.
+Added: Of these proceeds, $ 100.7 million in gross proceeds (€ 85.7 million, at the exchange rate of 1 EUR = $ 1.17 ) was received as of December 31, 2025, with the remaining amount received in January 2026.
+Added: The Accounting treatment is detailed into Note 1 Nature of the business and principles and accounting methods, Significant contracts .
+Added: At-The-Market (“ATM”) equity program offering
+Added: In September 2025, the Company entered into a Sales Agreement (the “Sales Agreement”) with Citizens JMP Securities, LLC (“Citizens”), with respect to an equity offering program (the “ATM Offering”) pursuant to which the Company may offer and sell ADSs, from time to time, through Citizens as its sales agent.
+Added: Pursuant to the Sales Agreement and a prospectus supplement the Company has filed related to the ATM Offering, the Company may offer and sell ADSs having an aggregate offering price of up to $ 150.0 million from time to time through Citizens.
+Added: The issuance and sale, if any, of the ADSs by the Company under the Sales Agreement will be made pursuant to the Company’s previously filed and effective registration statement on Form S-3 (Registration Statement No.
+Added: Sales of the Company’s ADSs, if any, in the ATM Offering may be made in sales deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act from time to time.
+Added: Pursuant to the ATM Offering, the Company received (i) a total gross amount of $ 30 million from the sale of 11,538,460 Ordinary Shares (underlying 2,307,692 ADSs) on October 6, 2025, (ii) a total gross amount of $ 30 million from the sale of 10,714,300 Ordinary Shares (underlying 2,142,860 ADSs) on October 29, 2025, and (iii) a total gross amount of $ 5 million from the sale of 1,700,000 Ordinary Shares (underlying 340,000 ADSs) on November 19, 2025.
+Added: The Company entered into a Manufacturing & Supply Agreement with SANOFI on August 29, 2025
+Added: On August 29, 2025, the Company entered into a Supply Agreement with SANOFI under which SANOFI will manufacture and supply the Viaskin Peanut API for the Company during the agreement term.
+Added: The Agreement has an initial term of 4 years with a possibility to extend for an additional period.
+Added: The effective date is January 1, 2025.
+Added: This Agreement includes terms related to manufacturing, quality control, pricing, volume commitments, and supply obligations.
+Added: The Agreement is designed to support commercial-scale API manufacturing capacity in preparation for a potential BLA submission and subsequently, the commercial launch of the Viaskin Peanut patch in the United States, if approved.
+Added: The Company has non-cancellable minimum commitments for products and services under the Supply Agreement.
+Added: Under US GAAP, take-or-pay arrangements are generally considered firm purchase commitments.
+Added: As of December 31, 2025, the Company has assessed its ability to meet the obligations as per U.S.
+Added: GAAP requirements (ASC 440-10:
+Added: Commitments, ASC 450-20:
+Added: Loss Contingencies and ASC 330-10-35:
+Added: Inventory and purchase commitments) and confirm to commit to agreed volumes.
+Added: Hence, we have not recognized on the balance sheet any loss provision.
+Added: The Company expects to incur expenditures related to support for BLA and PAI preparation, cold storage rental, over the Supply Agreement term.
+Added: These expenditures are consistent with the Company’s planned investments to strengthen its supply chain readiness ahead of potential regulatory milestones.
+Added: Implementation of a foreign exchange SWAP (Non-qualified derivative instrument)
+Added: DBV Technologies S.A.
+Added: entered on December 30, 2025, into a foreign currency swap with Société Générale to reduce the exposure to US dollar related to the operations with DBV Technologies Inc.
+Added: in the United States.
+Added: This instrument is based on a notional amount corresponding to the month-end treasury current account balance, valued at the spot rate on the transaction date, with a maturity running until the end of the following month to hedge the subsidiary's immediate operating needs, it can be completed by additional comparable derivatives in order to hedge additional needs.
+Added: As of December 31, 2025, the notional amount is $ 1.8 million with an initial spot rate of 1.1765 , with a rate of 1.1790 with a maturity January 30, 2026.
+Added: The “mark-to-market" valuation of the instrument as of December 31, 2025, is $( 5 ) thousands.
Legal Proceedings
3 unchanged sentences
The following table presents for each reported period, the breakdown of cash and cash equivalents:
−Removed: Cash 32,456 10,530
Cash equivalents
Total cash and cash equivalents as reported in the statements of financial position 194,167 32,456
−Removed: Cash equivalents are immediately convertible into cash at no or insignificant cost on demand.
+Added: Cash equivalents are convertible into cash at no or insignificant cost on demand within 32 days or less.
They are measured using Level 1 fair value measurements.
2 unchanged sentences
Research tax credit
−Removed: Other tax claims 4,452 5,236
Prepaid expenses
2 unchanged sentences
The other tax claims are primarily related to deductible VAT.
−Removed: Prepaid expenses are comprised primarily of insurance expenses, as well as legal and scientific consulting fees.
+Added: Prepaid expenses are comprised primarily of finance, legal as well as scientific consulting fees and insurance expenses.
Prepaid expenses also include upfront payments which are recognized over the term of the ongoing clinical studies.
Research tax credit
−Removed: 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.
−Removed: During the year ended December 31, 2023, the Company received the reimbursement of $ 6.0 million of the 2022 fiscal year research tax credits.
−Removed: During the year ended December 31, 2024, the Company received the reimbursement of the 2023 fiscal year research tax credits for a total amount of $ 8.7 million included 2020, 2021 and 2022 complementary research tax credit made during the fiscal year ended December 31, 2023.
−Removed: The variance in Research Tax Credit during the two years disclosed is presented as follows:
+Added: In the fiscal year ended December 31, 2021, the Company recovered its Small & Medium Enterprise “SME” status under EU law, and became therefore eligible again for the immediate reimbursement of the Research Tax Credit.
+Added: During the year ended December 31, 2025, the Company received the reimbursement of 2024 fiscal year research tax credit for a total amount of $ 4.3 million.
+Added: The variance in Research Tax Credit disclosed is detailed below:
Amount in thousands of US Dollars
Opening research tax credit receivable as of January 1, 2024
−Removed: +Operating revenue (1) 8,766
+Added: + Other operating income 4,146
- Payment received ( 8,676 )
- Adjustment and currency translation effect ( 348 )
−Removed: Closing research tax credit receivable as of December 31, 2023 8,857
−Removed: Of which - Non-current portion —
−Removed: Of which - Current portion 8,857
−Removed: Amount in thousands of US Dollars
Opening research tax credit receivable as of January 1, 2025 3,980
−Removed: + Operating revenue 4,146
+Added: + Other operating income
- Payment received
3 unchanged sentences
Of which - Current portion
−Removed: (1) Included 2020, 2021 and 2022 complementary research tax credit made during the fiscal year ended December 31, 2023.
Note 5 Property, Plant, and Equipment
Property and equipment, net consisted of the following:
−Removed: 01/01/2023 Currency translation effect Additions Disposals Reclassification 31/12/2023
+Added: 01/01/2024 Currency translation effect Increase Decrease Reclassification 31/12/2024
Laboratory equipment
10 unchanged sentences
Total, net 12,622 ( 726 ) ( 589 ) — — 11,306
−Removed: 01/01/2024 Currency translation effect Additions Disposals Reclassification 31/12/2024
+Added: 01/01/2025 Currency translation effect Increase Decrease Reclassification 12/31/2025
Laboratory equipment
14 unchanged sentences
(Amounts in thousands of US Dollars)
+Added: 31/12/2025 31/12/2024
Real Estate Other assets Total Real Estate Other assets Total
Current portion
−Removed: Year 2 1,222 7 1,228 65 11 75
−Removed: Year 3 1,230 7 1,237 421 — 421
−Removed: Thereafter 5,127 9 5,136 5,515 — 5,515
Total minimum lease payments
15 unchanged sentences
Right of use and related lease debt have been recorded starting November 2023 for a gross amount of $ 4.5 million.
+Added: Pursuant section 8 of the Sublease between DBV Technologies, Inc.
+Added: and Envision Pharma Inc.
+Added: for Premises located at 10 Independence Boulevard, Warren, New Jersey (“Sublease”), Envision Pharma Inc.
+Added: gave notice of its intention to terminate the Sublease as of December 30, 2026.
+Added: The Company adjusted accordingly the Right of Use asset and the lease liability and reclassed the remaining liability onto current liabilities.
Supplemental cash flow information related to operating leases is as follows for the year ended December 31, 2025 and 2024:
4 unchanged sentences
Other non-current assets consisted of the following:
−Removed: FX facility collateral account — 3,904
−Removed: Deposits, pledged securities, prepaid expenses and other non-current financial assets 4,312 2,074
+Added: Deposits, pledged securities and other non-current financial assets
Liquidity contract
Total non-current assets 5,809 4,423
−Removed: The other non-current assets are composed of security deposits paid to premises lessors, pledged securities and the liquidity contract.
−Removed: The collateral account to guarantee a FX facility is released as of December 31, 2024.
−Removed: Under the liquidity contract, 266,868 treasury shares were allocated as a reduction of Shareholders’ Equity as at December 31, 2024 with the cash balance being maintained in financial assets.
+Added: The other non-current assets are composed of Fareva La Vallée prepaid Right of Use, security deposits paid to premises lessors, pledged securities and the liquidity contract.
+Added: As per the Company liquidity contract, 74,580 treasury shares were allocated as a reduction of Shareholders’ Equity as of December 31, 2025, the cash balance being maintained in financial assets.
Note 8 Trade payables and Other Current Liabilities
3 unchanged sentences
Other current liabilities consisted of the following:
−Removed: Social debt 7,294 7,828
Tax liabilities
−Removed: Other debts 846 883
Total 15,750 8,328
−Removed: Social debt includes short-term debt related to employees’ bonus accruals, as well as social welfare and tax agencies.
−Removed: Note 9 Other Current Liabilities
+Added: The increase in social debt compared to the prior period primarily reflects (i) the expansion of the Company’s teams, resulting in higher payroll‑related liabilities, (ii) higher bonus accruals recognized in line with performance and headcount growth, and (iii) the corresponding increase in social security and payroll tax contributions associated with these accruals.
Due dates of liabilities
The following table shows the maturity of the Company’s liabilities (except leases disclosed in “Note 6 - Lease contract”):
−Removed: Carrying 2025 2026 2027 2028 Thereafter
+Added: Amount 2025 2026 2027 2028 Thereafter
Other liabilities 15,750
Supplier accounts payable and related payables 40,941
−Removed: Total Other Current Liabilities 30,360 30,360 — — — —
−Removed: The current portion of other liabilities mainly includes social security.
+Added: Total Liabilities 56,691 56,691 — — — —
Note 9 Fair Value Measurement
2 unchanged sentences
Valuation techniques maximize the use of observable inputs and minimize the use of unobservable inputs.
−Removed: 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.
+Added: 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, deposits, liquidity contract, accounts payable, and conditional advances.
The fair values of these financial instruments are deemed to approximate their carrying amount.
−Removed: The fair values of cash and cash equivalents, accounts receivable, deposits, liquidity contract and accounts payable are categorized as Level 1.
−Removed: 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.
−Removed: 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, 2024 and 2025.
+Added: The financial instruments recognized on the balance sheet are analyzed as follows as of December 31, 2024 :
+Added: Breakdown by financial instrument class - balance sheet value Level of fair value
+Added: (in thousands of dollars) Carrying value Fair value through P&L Assets at amortized cost Liabilities at amortized cost Derivative financial instrument Level 1 Level 2 Level 3
+Added: Deposits 4,312 — 4,312 — — — —
+Added: Liquidity contract 111 111 — — — 111 — —
+Added: Accounts receivable 680 — 680 — — — — —
+Added: Cash and cash equivalents 32,456 32,456 — — — 32,456 — —
+Added: Total Assets 37,559 32,567 4,992 — — 32,567 — —
+Added: Other liabilities 8,328 0 0 8,328 0 0 0 0
+Added: Accounts payables 22,032 0 0 22,032 0 0 0 0
+Added: Total Liabilities 30,360 — — — — — 30,360 — — — — — — — —
+Added: The financial instruments recognized on the balance sheet are analyzed as follows as of December 31, 2025 :
+Added: Breakdown by financial instrument class - balance sheet value Level of fair value
+Added: Carrying value Fair value through P&L Assets at amortized cost Liabilities at amortized cost Derivative financial instrument Level 1 Level 2 Level 3
+Added: Deposits 5,189 0 5,189 0 0 0 0 0
+Added: Liquidity contract 620 620 0 0 0 620 0 0
+Added: Cash and cash equivalents 194,167 194,167 0 0 0 194,167 0 0
+Added: Total Assets 199,977 194,788 5,189 — — 194,788 — —
+Added: Other liabilities 15,750 5 0 15,750 5 5 0 0
+Added: Accounts payables 40,941 0 0 40,941 0 0 0 0
+Added: Total Liabilities 56,691 5 — 56,691 5 5 — —
+Added: Financial instruments evolved during the year primarily as a result of the financings conducted resulting in a significant increase in cash and cash equivalents .
+Added: Derivative Instruments
+Added: The Company is exposed to increasing foreign exchange risk due to a portion of its procurement activities being conducted in the United States and invoiced in U.S.
+Added: dollars, as well as the activity of its subsidiary DBV Technologies Inc., in connection with the Company’s preparation for the potential launch of the VIASKIN Peanut patch in the United States, if approved.
+Added: This exposure has been increased by the continued depreciation of the U.S.
+Added: dollar observed over the past year, which increases volatility and uncertainty regarding foreign‑currency‑denominated operating costs.
+Added: In this context, since 2025, the Company has hedged the current account of its US subsidiary through the use of financial instruments (foreign exchange swaps entered into with banking counterparties), which are linked to the subsidiary’s current account as of December 31, 2025.
+Added: The Company’s policy is not to enter into derivative transactions for speculative purposes.
+Added: (In Million of dollars) As of December 31, 2025
+Added: Notional amount Fair value Due date
+Added: Asset Liabilities <1 year 1 – 5 years >5 years
+Added: Foreign exchange SWAP
+Added: Forward sale at maturity Non-qualified derivative 1,800 — 1,800
+Added: The impact of financial instruments not qualifying for hedge accounting of future cash flows is included in “Foreign exchange gains/(losses) (excluding operating activities)” within financial result ($( 5 ) thousand as of December 31, 2025).
+Added: The Company did not hold any derivative instruments in 2024.
Note 10 Share Capital Issued
−Removed: The share capital, as of December 31, 2024, is set at the sum of € 10,284,750 ($ 11,650,708 converted at historical rates).
+Added: The share capital, as of December 31, 2025, is set at the sum of $ 26,911,786.4 (€ 23,567,086.40 ).
It is divided into 235,670,864 fully authorized, subscribed and paid-up shares with a nominal value of € 0.10 .
−Removed: 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.
−Removed: All the shares give their owners the right to a proportional share of the income and the net assets of the Company.
−Removed: Pursuant to the authorization granted by the SH General Meeting, the Board of Directors, at its meeting of June 9, 2023 (the “Board General Meeting”):
−Removed: • 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;
−Removed: • granted a number of authorizations for the purpose of carrying out the issuance;
−Removed: • sub-delegated its authority to the Chief Executive Officer for the purpose of implementing the financing.
−Removed: 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:
−Removed: • 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.
−Removed: 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.
−Removed: a capital increase of a nominal amount of € 3,285,566.90 together with a share premium of € 95,281,440.10 , i.e.
−Removed: 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;
−Removed: • decided to set the maximum nominal amount of the capital increase resulting from the full exercise of the prefunded warrants at € 2,827,633.10 , by issuing a maximum of 28,276,331 ordinary shares, with a value of € 0.10 to be subscribed in cash at the price of € 0.10 (without share premium), and to be fully paid up at the time of subscription, i.e.
−Removed: 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;
−Removed: • 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.
−Removed: The Company has assessed the pre-funded warrants for appropriate equity or liability classification.
−Removed: 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.
−Removed: 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.
−Removed: In addition, the 2022 Warrants do not provide any guarantee of value or return.
−Removed: 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.
−Removed: The changes in number of outstanding prefunded warrants are as follows:
−Removed: Prefunded warrants
−Removed: Balance as of December 31, 2023 28,276,331
−Removed: Granted during the period —
−Removed: Forfeited during the period —
−Removed: Exercised/released during the period ( 6,010,000 )
−Removed: Expired during the period —
−Removed: Balance as of December 31, 2024 22,266,331
−Removed: The table below presents the changes in the share capital of the Company as of December 31, 2023 and 2024:
+Added: The 2024 General Meeting held on June 11, 2025, duly convened and validly deliberating under the quorum and majority conditions applicable to ordinary general meetings, having reviewed the report of the Board of Directors, resolved to allocate the entire loss for the financial year ended December 31, 2024, amounting $( 40,192,552.87 ) (€ 35,154,861.25 ) against the share premium account (Allocation of accumulated net losses).
+Added: The General Meeting held on May 16, 2024, duly convened and validly deliberating under the quorum and majority conditions applicable to ordinary general meetings, having reviewed the report of the Board of Directors, resolved to allocate the entire loss for the financial year ended December 31, 2023, amounting to $ 66,432,799.17 (€ 61,327,401.00 ), to the debit balance of retained earnings (accumulated deficit).
+Added: The General Meeting also resolved to offset the same amount against the share premium account (Allocation of accumulated net losses).
+Added: With respect to the 2025 PIPE financing, the transaction and its accounting treatment are described into Note 1 Nature of the business and principles and accounting methods, Significant contracts.
+Added: The 2022 Warrants were classified as a component of permanent equity because they were 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.
+Added: In addition, the 2022 Warrants did not provide any guarantee of value or return.
+Added: Accordingly, the pre-funded warrants were classified as equity and accounted for as a component of additional paid-in capital at the time of issuance.
+Added: The table below presents the changes in the share capital of the Company as of December 31, 2024 and 2025 at historical rate:
Amounts in thousands of U.S.
4 unchanged sentences
Capital increase by employee warrants
+Added: Capital increase by employee warrants
Retained earnings charged on share premium
−Removed: 05/19/2023 Capital increase by ordinary shares 0 0 2,500
−Removed: 05/22/2023 Capital increase by ordinary shares 2 ( 2 ) 14,374
−Removed: 05/24/2023 Capital increase by ordinary shares 4 ( 4 ) 34,321
−Removed: 06/16/2023 Capital increase by ATM program 225 6,696 2,052,450
−Removed: 09/23/2023 Capital increase by ordinary shares 0 0 2,599
−Removed: 10/25/2023 Capital increase by ordinary shares 4 ( 4 ) 35,000
−Removed: 11/19/2023 Capital increase by ordinary shares 0 0 2,500
−Removed: 11/21/2023 Capital increase by ordinary shares 6 - 6 57,775
+Added: Capital increase by employee warrants
+Added: Capital increase by employee warrants
+Added: Capital increase by employee warrants
+Added: Capital increase by employee warrants
+Added: Capital increase by employee warrants
+Added: Capital increase by share warrants
+Added: Capital increase by employee warrants
+Added: Capital increase by employee warrants
+Added: Capital increase by employee warrants
+Added: Capital increase by employee warrants
+Added: Capital increase by employee warrants
+Added: Capital increase by employee warrants
+Added: Balance as of December 31, 2024 11,650,708 310,993 102,847,501
+Added: Share base payment accrual
+Added: Total Equity RFW as of December 31, 2024 11,650,708 315,613 102,847,501
+Added: Capital increase by employee warrants
+Added: Capital increase by employee warrants
+Added: Capital increase by employee warrants
Capital increase by ordinary shares
+Added: Capital increase by employee warrants
+Added: Capital increase by employee warrants
+Added: Capital increase by employee warrants
+Added: Retained earnings charged on share premium
+Added: Capital increase by employee warrants
Capital increase by ordinary shares
−Removed: 12/31/2023 Share-based payments 6,020
−Removed: Balance as of December 31, 2023 10,972 377,468 96,431,770
Capital increase by ordinary shares
Capital increase by ordinary shares
−Removed: 05/16/2024 Retained earnings charged on share premium ( 66,433 )
Capital increase by ordinary shares
1 unchanged sentence
Capital increase by ordinary shares
+Added: Capital increase by employee warrants
Capital increase by ordinary shares
+Added: Capital increase by employee warrants
Capital increase by ordinary shares
Capital increase by employee warrants
+Added: Capital increase by employee warrants
Capital increase by ordinary shares
Capital increase by ordinary shares (1)
+Added: Capital increase by employee Stock Option (1)
Capital increase by ordinary shares
2 unchanged sentences
Capital increase by ordinary shares
−Removed: 12/31/2024 Share-based payments 4,620
+Added: Capital increase by ordinary shares
Balance as of December 31, 2025 26,911,786 465,811 235,670,864
−Removed: * Conversion at historical rate
−Removed: In May 2024, pursuant to the authorization granted by the General Meeting of the Shareholders held on May 16, 2024, the accumulated net losses of DBV Technologies S.A.
−Removed: after appropriation of the net result for the year ended December 31, 2023 have been allocated to additional paid-in capital in the amount of $ 66.4 million (€ 61.1 million converted at historical rates).
+Added: Share base payment accrual
+Added: Issuance of warrants
+Added: Total Equity RFW as of December 31, 2025 26,911,786 541,251 235,670,864
+Added: (1) The dates on which capital increases are recognized do not follow a strictly chronological order, as certain transactions were recorded retrospectively in order to reflect adjustments resulting from the exercise of financial instruments and financing transactions that occurred previously.
+Added: (2) Share premiums are presented and accounted for in accordance with the terms described in Note 1 - Share Capital
Note 11 Share-Based Payments
−Removed: 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:
+Added: The Board of Directors has been authorized by the General Meeting of the Shareholders to grant RUSs, SOs, and BSAs for the last three years, as follows:
Share-based payments instrument General meeting of shareholders Board of directors meeting Grant date Number granted
−Removed: BSA 12/9/2011 9/25/2012 9/25/2012 30,000
−Removed: BSA 6/4/2013 7/25/2013 7/25/2013 73,000
−Removed: SO 12/9/2011 9/18/2013 9/18/2013 518,000
−Removed: BSA 6/3/2014 3/24/2015 3/24/2015 10,000
−Removed: SO 6/3/2014 6/23/2015 6/23/2015 120,000
−Removed: BSA 6/23/2015 11/19/2015 11/19/2015 22,500
−Removed: BSA 6/23/2015 12/15/2015 12/15/2015 90,000
−Removed: SO 6/3/2014 4/6/2016 4/21/2016 33,000
−Removed: SO 6/3/2014 6/21/2016 6/21/2016 110,000
−Removed: BSA 6/21/2016 6/21/2016 8/21/2016 20,000
−Removed: SO 6/3/2014 6/21/2016 9/15/2016 93,000
−Removed: SO 6/3/2014 6/21/2016 10/17/2016 16,500
−Removed: BSA 6/21/2016 12/9/2016 12/9/2016 59,000
−Removed: SO 6/3/2014 12/9/2016 12/9/2016 74,960
AGA 12/4/2023 1/9/2023 1/9/2023 35,800
−Removed: AGA 9/21/2015 4/20/2017 4/20/2017 24,000
−Removed: BSA 6/15/2017 6/15/2017 6/15/2017 9,000
SO 12/4/2023 1/9/2023 1/9/2023 59,200
−Removed: SO 6/15/2017 6/15/2017 6/15/2017 111,600
−Removed: SO 6/15/2017 6/15/2017 9/15/2017 52,600
−Removed: SO 6/15/2017 11/17/2017 12/5/2017 625,200
−Removed: BSA 6/15/2017 5/2/2018 5/2/2018 44,000
AGA 12/4/2023 11/20/2023 11/20/2023 912,650
−Removed: AGA 6/22/2018 9/6/2018 9/6/2018 450
SO 12/4/2023 11/20/2023 11/20/2023 2,290,722
−Removed: SO 6/22/2018 6/22/2018 10/15/2018 76,700
AGA 12/4/2023 1/16/2024 1/16/2024 59,000
2 unchanged sentences
SO 5/16/2024 5/16/2024 5/16/2024 272,000
−Removed: SO 6/22/2018 6/22/2018 3/20/2019 547,100
AGA 5/16/2024 11/21/2024 11/21/2024 1,181,700
1 unchanged sentence
SO 5/16/2024 12/4/2024 12/4/2024 813,200
−Removed: SO 5/24/2019 5/24/2019 7/22/2019 75,000
AGA 11/6/2025 6/23/2025 6/23/2025 35,000
1 unchanged sentence
AGA 11/6/2025 11/21/2025 11/21/2025 1,470,600
−Removed: AGA 4/20/2020 4/20/2020 4/29/2020 20,000
−Removed: AGA 4/20/2020 11/24/2020 11/24/2020 475,000
SO 11/6/2025 11/21/2025 11/21/2025 4,091,150
−Removed: AGA 4/20/2020 3/23/2021 3/23/2021 24,900
−Removed: SO 4/20/2020 3/23/2021 3/23/2021 75,200
−Removed: AGA 5/19/2021 5/19/2021 5/19/2021 20,000
−Removed: BSA 5/19/2021 5/19/2021 6/3/2021 39,185
−Removed: AGA 5/19/2021 11/22/2021 11/22/2021 257,300
−Removed: SO 5/19/2021 11/22/2021 11/22/2021 1,107,300
−Removed: AGA 5/19/2021 5/12/2022 5/12/2022 3,200
−Removed: SO 5/19/2021 5/12/2022 5/12/2022 19,000
−Removed: AGA 5/12/2022 7/29/2022 7/29/2022 66,700
−Removed: SO 5/12/2022 7/29/2022 7/29/2022 135,500
−Removed: AGA 5/12/2022 11/21/2022 11/21/2022 519,650
−Removed: SO 5/12/2022 11/21/2022 11/21/2022 1,771,786
−Removed: AGA 4/12/2023 1/9/2023 1/9/2023 35,800
−Removed: SO 4/12/2023 1/9/2023 1/9/2023 59,200
−Removed: AGA 4/12/2023 11/20/2023 11/20/2023 912,650
−Removed: SO 4/12/2023 11/20/2023 11/20/2023 2,290,722
−Removed: AGA 4/12/2023 1/16/2024 1/16/2024 59,000
−Removed: SO 4/12/2023 1/16/2024 1/16/2024 262,000
−Removed: AGA 5/16/2024 5/16/2024 5/16/2024 65,000
−Removed: SO 5/16/2024 5/16/2024 5/16/2024 272,000
−Removed: AGA 5/16/2024 11/21/2024 11/21/2024 1,181,700
−Removed: SO 5/16/2024 11/21/2024 11/21/2024 2,267,300
−Removed: SO 5/16/2024 12/4/2024 12/4/2024 813,200
In the following tables related to share-based payments, exercise prices, grant date share fair values and fair value per equity instruments are provided in euros, as the Company is incorporated in France and the euro is the currency used for the grants.
6 unchanged sentences
The fair value of the warrants has been estimated using the Cox-Ross Rubinstein binomial option pricing model.
−Removed: Warrant fair value assumptions during the year ended December 31, 2021:
+Added: Warrant fair value assumptions are:
Weighted average share price at grant date (in €)
4 unchanged sentences
Weighted average fair value of warrants (in €)
+Added: The Company no longer grants neither BSA or BSPCE to non-employee members of the Board of Directors or to members of the Scientific Advisory Board.
The following table summarizes all BSA warrants activity during the year ended December 31, 2024:
1 unchanged sentence
Balance as of December 31, 2023 244,693 49.43 3.47 —
−Removed: Granted during the period — — — —
−Removed: Forfeited during the period — — — —
−Removed: Exercised/released during the period — — — —
Expired during the period — —
4 unchanged sentences
Balance as of December 31, 2024 244,693 49.43 2.47 —
−Removed: Granted during the period — — — —
−Removed: Forfeited during the period — — — —
−Removed: Exercised/released during the period — — — —
Expired during the period ( 137,685 )
1 unchanged sentence
Warrants exercisable as of December 31, 2025 107,008
−Removed: 12.2 Employee warrants
−Removed: As of December 31, 2023 no more BSPCE / BCE warrants (Bons de Souscription de Parts de Créateur d’Entreprise or “BSPCE”) are exercisable.
11.2 Stock options
−Removed: The Company’s Board of Directors has been authorized by the shareholders’ general meeting to grant SOs to employees.
+Added: The Company’s Board of Directors has been authorized by the shareholders’ general meeting to grant SO to employees.
The different stock options plans granted by the Board of Directors are similar in their nature and conditions, except for the exercise price that is comprised between € 0.71 and € 74.22 .
16 unchanged sentences
Granted during the period
+Added: Forfeited during the period ( 283,938 )
+Added: Exercised during the period —
Expired during the period ( 15,300 )
6 unchanged sentences
Forfeited during the period ( 486,300 )
−Removed: Exercised during the period — — — —
+Added: Delivered during the period ( 40,075 )
Expired during the period ( 128,100 )
1 unchanged sentence
Options exercisable as of December 31, 2025 2,751,695
−Removed: As of December 31, 2024, there was € 17.9 million ($ 19.3 million converted at closing rate) of unrecognized SO expense that is expected to be recognized over a weighted-average period of 3.5 years.
+Added: 6.18 4.31 2,766,171
+Added: The expense recognized into the Consolidated statements of operations is $ 4.1 millions dollars as of December 31, 2025, against $ 3.3 million as of December 31, 2024.
Fair value of stock options
14 unchanged sentences
The Company estimated the following assumptions for the calculation of the fair value of the stock options:
−Removed: Assumptions per year ended, December 31,
Stock options per grant date 2025 2024
3 unchanged sentences
Weighted average expected term (in years) 6.25 6.25
−Removed: Dividend yield — — — — — — —
Weighted average fair value of stock-options in € 1.73 0.57
17 unchanged sentences
Balance as of December 31, 2023 2,021,370 11.03
−Removed: 1,589,081 14.69
Granted during the period
1 unchanged sentence
Released during the period ( 339,426 )
−Removed: Expired during the period — —
Balance as of December 31, 2024 2,813,366 7.67
−Removed: 2,021,370 11.03
The following table summarizes all RSUs activity for the year ended December 31, 2025:
1 unchanged sentence
Balance as of December 31, 2024 2,813,366 7.67
−Removed: 2,021,370 11.03
Granted during the period 1,505,600
−Removed: 1,305,700 0.60
Forfeited during the period 32,380
Released during the period ( 742,999 )
−Removed: Expired during the period — —
Balance as of December 31, 2025 3,608,347 6.61
−Removed: 2,813,366 7.67
−Removed: As of December 31, 2024, there was € 3.8 million (US$ 4.2 million converted at closing rate) of unrecognized RSUs compensation expense that is expected to be recognized over a weighted-average period of 3.2 years.
+Added: The expense recognized into the Consolidated statements of operations is stable at $ 1.3 millions dollars as of December 31, 2025 and as of December 31, 2024.
+Added: The forfeited bucket includes contingent stock options.
11.4 Reconciliation of the share-based payment expenses with the Consolidated Statements of Operations and Comprehensive Loss
−Removed: Research & development SO ( 1,431 ) ( 1,661 )
−Removed: RSU ( 913 ) ( 835 )
−Removed: Sales & marketing SO ( 80 ) ( 102 )
−Removed: RSU ( 35 ) ( 33 )
−Removed: General & administrative SO ( 1,794 ) ( 2,985 )
−Removed: RSU ( 367 ) ( 403 )
+Added: Research & development
+Added: Sales & marketing
+Added: General & administrative
Total share-based compensation (expense) ( 5,387 ) ( 4,620 )
−Removed: Note 13 Contingencies
+Added: Note 12 Contingencies & Employee Benefits
Non-current contingencies and current contingencies break down as follows:
3 unchanged sentences
The table below shows movements in contingencies:
−Removed: Pension retirement obligations Collaboration agreement - Loss at completion Other contingencies Total
+Added: Pension retirement obligations Other contingencies Total
At January 1, 2024
1 unchanged sentence
Increases in liabilities 88 125 212
−Removed: Reversals of unused liabilities — ( 20,108 ) — ( 20,108 )
+Added: Used liabilities — ( 3,877 ) ( 3,877 )
Actuarial gains and losses on defined-benefit plans ( 163 ) — ( 163 )
Currency translation effect ( 22 ) ( 84 ) ( 105 )
−Removed: At December 31, 2023
−Removed: 935 — 3,958 4,894
−Removed: Of which current — — 3,958 3,958
−Removed: Of which non-current 935 — — 935
At January 1, 2025
−Removed: 935 — 3,958 4,894
Increases in liabilities
−Removed: Used liabilities — — ( 3,877 ) ( 3,877 )
Actuarial gains and losses on defined-benefit plans
4 unchanged sentences
Of which non-current 1,513 — 1,513
+Added: Collective agreement
+Added: National Collective Agreement of
+Added: the pharmaceutical industry ;
The Company does not hold any plan assets for any of the periods presented.
−Removed: The evolution as of December 31, 2024 compared with December 31, 2023 is mainly due to the signature by the Company of a Mutual Termination Letter Agreement with NESTEC on October 30, 2023 which generated the following impacts as of December 31, 2023 :
−Removed: • Loss on completion accrual reversal of $ 19.9 million;
−Removed: • Accrual for ongoing Clinical study completion of $ 2.3 million as of December 31, 2023.
−Removed: This updated accrual of $ 22 thousand represents our best estimate of the remaining expenses related to the ongoing clinical study which will be incurred after December 31, 2024 and until the end of the study.
As part of the estimation of the retirement commitments, the following assumptions were used for all categories of employees:
4 unchanged sentences
Estimated retirement age
−Removed: Life table TGH05-TGF05
−Removed: Collective agreement National Collective Agreement of
+Added: Collective agreement
+Added: National Collective Agreement of
the pharmaceutical industry
4 unchanged sentences
Total 5,636 4,151
−Removed: Until the end of 2023, our operating income was composed of both the French Research tax credit (Crédit d’Impôt Recherche, or “CIR”) and the revenue recognized under the Collaboration Agreement with NESTEC.
−Removed: Following the termination of the Collaboration Agreement on October 30, 2023, we recorded a deferred revenue accrual reversal of $ 7.0 million and our operating income is now exclusively generated by the French research tax credit.
−Removed: The decrease in Research tax credit was primarily due to:
−Removed: ◦ a complementary Research tax credit for $ 2.9 million recorded in 2023 for the years 2020, 2021 and 2022
−Removed: ◦ a greater proportion of study activities carried out in North America in 2024, compared with 2023, that were therefore not eligible to the French Research tax credit.
+Added: We generated an operating income of $ 5.6 million for the year ended December 31, 2025 compared to $ 4.2 million for the year ended December 31, 2024.
+Added: This increase reflects higher eligible activities performed during the period.
Note 14 Operating expenses and Allocation of Personnel Expenses
1 unchanged sentence
Research and Development Expenses
−Removed: The following table summarizes our research and development expenses for the years presented:
+Added: The following table summarizes our research and development expenses for the years reported:
2025 2024 $ change % of change
3 unchanged sentences
Share-based payment expenses
−Removed: Depreciation and amortization ( 719 ) ( 13,658 ) 12,939 ( 95 ) %
−Removed: Other costs 8,058 7,940 118 1 %
+Added: Depreciation, amortization and other costs
+Added: Pre-Commercial Inventory
Total Research and Development expenses 116,682 89,342 27,341 31 %
−Removed: Research and Development expenses increased by $ 29.1 million for the year ended December 31, 2024 compared to the year ended December 31, 2023, essentially due to external clinical-related expenses increasing by $ 13.4 million from both patient enrollment in VITESSE Phase 3 clinical trial sustainable increase after the initiation of the study with the first patient screened in March 2023 and the preparatory activities for the COMFORT studies in preparation for and anticipation of initiation after FDA alignment.
−Removed: Employee-related costs, excluding share-based payments, increased by $ 2.8 million for the year ended December 31, 2024 compared to the year ended December 31, 2023 due to the recruitment of 12 FTE in Medical, Quality and Regulatory Affairs, mostly based in the U.S.
−Removed: Depreciation, amortization and other costs increased by $ 12.9 million for the year ended December 31, 2024 compared to the year ended December 31, 2023, due to (1) the termination of the Collaboration Agreement with NESTEC that explained the accrual net reversal in 2023, (2) accruals reversal on CRO activities and (3) Medical, Quality and Regulatory Affairs activities.
+Added: Research and Development expenses increased by $ 27.3 million for the year ended December 31, 2025 compared to the year ended December 31, 2024.
+Added: Pre-Commercial Inventory of $ 16.1 million reflects inventory build-up inception in anticipation of potential FDA approval.
+Added: External clinical-related expenses increased by $ 6.9 million, due to higher clinical trial activity driven by the initiation of patient recruitment for the COMFORT Toddlers study.
+Added: This increase was partially offset by (1) lower spend compared to 2024 on the VITESSE Study following completion of final patient visits in 2025 and (2) from other studies that are completed or nearing completion.
+Added: Employee-related costs, excluding share-based payments, increased by $ 3.3 million for the year ended December 31, 2025 compared to the year ended December 31, 2024 primarily driven by full-time employees (“FTE”) growth.
+Added: This increase reflects the full-year impact in 2025 of hires made in 2024, combined with additional recruitments in 2025.
+Added: These hires were mainly in Medical Affairs, Quality, and Regulatory functions, primarily based in the U.S., and were made to support BLA submission and Commercial readiness activities.
+Added: The increase also includes certain one-off costs related to the strong operational execution delivered in 2025.
+Added: Depreciation and amortization increased by $ 2.6 million for the year ended December 31, 2025 compared to the year ended December 31, 2024, consequently to an accrual reversal related to CRO activities in the prior year, having a positive impact on the income statement and offsets the recurring depreciation and amortization.
Sales and Marketing Expenses
6 unchanged sentences
Total Sales & Marketing expenses 3,222 2,659 561 21 %
−Removed: Sales and marketing expenses increased by $ 0.2 million or the year ended December 31, 2024 compared to the year ended December 31, 2023, primarily to support pre-commercialization activities for Viaskin Peanut in North America.
+Added: Sales and marketing expenses increased by $ 0.6 million or the year ended December 31, 2025 compared to the year ended December 31, 2024.
+Added: This increase was primarily attributable to higher pre-commercialization costs and increased headcount to support commercial readiness for Viaskin Peanut in North America.
General and Administrative Expenses
7 unchanged sentences
Total General & Administrative expenses 32,788 28,739 4,049 14 %
−Removed: General and administrative expenses decreased by $ 0.8 million for the year ended December 31, 2024, compared to the year ended December 31, 2023.
−Removed: External professional services increased by $ 1.3 million for the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due to one-time costs associated with (1) office moves in France and the U.S, (2) financing activities and (3) trademark and patent activities.
−Removed: This increase is offset by a decrease in Depreciation, amortization and other costs by $ 1.6 million for the year ended December 31, 2024, compared to the year ended December 31, 2023 primarily due to the provision reversal on the Montrouge office revamping.
+Added: General and administrative expenses increased by $ 4.0 million for the year ended December 31, 2025, compared to the year ended December 31, 2024.
+Added: The increase was primarily attributable to higher Employee-related costs, excluding share-based payments, which increased by $ 4.0 million driven by growth in full-time employees.
+Added: These hires were mainly in Human Resources, Information Solutions, Finance, and Legal and Compliance functions to support commercial readiness.
+Added: The increase also includes certain one-off costs related to strong operational execution in 2025.
+Added: This increase was partially offset by a $ 1.0 million decrease in External professional services, primarily due to the absence of one-time costs incurred in the prior year related to office relocations in France and the U.S., and trademark and patent activities.
Allocation of Personnel Expenses by Function:
−Removed: The Company had 108 average employees for the year ended December 31, 2024, in comparison with 104 employees for the year ended December 31, 2023.
+Added: The Company had 125 full time employees for the year ended December 31, 2025, in comparison with 108 employees for the year ended December 31, 2024.
Research and development expenses 22,783
1 unchanged sentence
General and administrative expenses
−Removed: Total personnel expenses including SBP costs 31,588 29,240
+Added: Total personnel expenses 40,021
Allocation of Personnel Expenses by Nature:
3 unchanged sentences
Share-based payments 5,387
−Removed: Total 31,588 29,240
−Removed: The increase in personnel expenses is mainly due to the recruitment of internal resources mostly based in North America to support development activities and quality activities.
−Removed: Note 16 Income Tax
+Added: Total personnel expenses 40,021
+Added: The increase in personnel expenses is primarily driven by full-time employees (“FTE”) growth.
+Added: This increase reflects the full-year impact in 2025 of hires made in 2024, combined with additional recruitments in 2025.
+Added: These hires were mainly in Medical Affairs, Quality, Regulatory and G&A functions, primarily based in the U.S., and were made to support BLA submission and Commercial readiness.
+Added: The increase also includes certain one-off costs related to strong execution in 2025.
+Added: Note 15 Income Tax & deferred Taxes
Reconciliation between the Effective and Nominal Income Tax Expense
−Removed: The following table shows the reconciliation between the effective and nominal tax expense at the nominal standard French rate 25 % as of December 31, 2024 and December 31, 2023 (excluding additional contributions):
−Removed: (Loss) before taxes ( 113,864 ) ( 72,709 )
−Removed: Theoretical company tax rate 25.00 % 25.00 %
−Removed: Nominal tax expense 28,466 18,179
−Removed: Increase/decrease in tax expense arising from:
−Removed: Research tax credit 1,037 2,192
−Removed: Share-based compensation ( 735 ) ( 1,852 )
−Removed: Other permanent differences ( 201 ) ( 110 )
−Removed: Non recognition of deferred tax assets mainly related to tax losses ( 28,608 ) ( 18,802 )
−Removed: Other differences ( 14 ) 386
−Removed: Effective tax expenses ( 55 ) ( 7 )
−Removed: Effective tax rate 0.05 % 0.01 %
+Added: As a French listed company, DBV determined its statutory tax rate based on its country of domicile, France [Domestic], which has a corporate income tax rate of 25%.
+Added: In accordance with the income tax rate reconciliation and disaggregation requirements of ASU 2023‑09, the Company evaluates income taxes paid by jurisdiction rather than solely by domicile.
+Added: Pursuant to the Company’s transfer pricing arrangements, DBV incurred and paid U.S.
+Added: income taxes representing 100% of total income taxes paid for fiscal year ended December 31, 2025 and December 31, 2024 .
+Added: Accordingly, the United States is presented as a separate significant jurisdiction.
+Added: Income taxes paid in other foreign jurisdictions are aggregated within the “Foreign” category, with Australia comprising the remaining foreign taxes paid.
+Added: Income (loss) from continuing operations before income tax expense (Benefit)
+Added: Current tax expense (benefit)
+Added: Total Current tax expense (benefit)
+Added: Total deferred tax expense (benefit)
+Added: Total income tax expense (benefit)
+Added: Pre-Tax Income (Loss) :
+Added: French Federal statutory income tax rate / Expense (Benefit)
+Added: Domestic federal reconciling items
+Added: Valuation Allowance
+Added: Issuance costs
+Added: Foreign Tax effects
+Added: Effective Tax Expense (Benefit) :
Deferred Tax Assets
4 unchanged sentences
Share-based compensation
−Removed: Personnel-related accruals 604 422
−Removed: Pension retirement obligations 209 509
−Removed: Leases 100 32
−Removed: Other 403 1,205
Total deferred tax assets
2 unchanged sentences
Note 16 Commitments
−Removed: Purchase Obligations
−Removed: The Company has signed agreements with several contract research organizations (CRO) and part of the ongoing clinical studies for Viaskin Peanut and Viaskin Milk products.
−Removed: As of December 31, 2024, expenses associated with the ongoing trials amounted globally to $ 170.3 million, and we had non-cancellable contractual obligations with CRO until year ended 2026 amounting to $ 10.0 million.
+Added: In connection with the launch of our clinical trials we have entered into service agreements with several CROs.
+Added: As of December 31, 2025, expenses associated with the ongoing trials amounted globally to $ 32.7 million, and we had non-cancellable contractual obligations with CROs amounting to 89.8 million.
+Added: The Company has entered into multi‑year supply and manufacturing agreements that include minimum purchase obligations over defined periods.
+Added: Under applicable accounting guidance, take‑or‑pay commitments are generally considered firm purchase commitments but remain off‑balance sheet unless they create an unavoidable or unconditional payment obligation, or become loss contract.
+Added: On August 29, 2025, the Company entered into the Supply Agreement with SANOFI under which SANOFI will manufacture and supply the Viaskin® Peanut API exclusively for DBV Technologies S.A.
+Added: during the agreement term.
+Added: Under such, the Company has agreed to certain minimum purchase levels and service fees over the initial 4 -year-term.
+Added: As of December 31, 2025, total payments made during the period under the Supply Agreement were approximately $ 8.6 million, which were recorded as R&D expenses.
+Added: The Company will expense manufacturing and supply costs as incurred.
+Added: On March 17, 2026, DBV Technologies S.A.
+Added: entered into the MS Agreement with FLV, under which FLV will manufacture and supply PSM, exclusively for DBV Technologies S.A.
+Added: during the agreement term.
+Added: The term is effective for a period of eight ( 8 ) years and can be renewed for a period of two ( 2 ) years .
+Added: As of December 31, 2025, total payments made during the year under the MS Agreement are approximately $ 1.4 million, which were recorded as detailed in Note 1 Nature of the business and principles and accounting methods, Significant contracts .
+Added: The following table presents our material expenses commitments for future periods:
+Added: 2026 2027 2028 Thereafter Total
+Added: (Amounts in million)
+Added: Purchase obligations - Obligations Under the Terms of CRO Agreements
+Added: Purchase obligations - Obligations Under the Terms of CMO Agreements
+Added: Total 44.0 37.6 37.8 19.1 138.5
Letter of Credit and Collateral
2 unchanged sentences
The compensation amounts for 2025 presented below, which were awarded to the Directors and Officers of the Company totaled $ 14.4 million.
−Removed: 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.
+Added: The recipients of this compensation are “related parties”.
Short-term benefits
5 unchanged sentences
Amounts payable to related parties as of December 31, 2025 and 2024 are as follows:
−Removed: Compensation 1,532 2,112
Pension obligations
Total 3,087 1,635
+Added: No significant related‑party transactions were identified during the financial years ended December 31, 2025 and 2024.
+Added: Recent events relating to related parties are presented in Item 7.
+Added: The information presented for 2025 includes employer social security contributions due in respect of these rewards.
+Added: The parent company, DBV Technologies S.A., entered into a cash‑pooling agreement with its subsidiaries (DBV Technologies Inc., DBV Technologies Australia Pty Ltd and DBV Pharma SAS), the balance of which amounts to the following as at year‑end:
+Added: Loans & Advances
+Added: Total 1,800 2,112
Note 18 Loss Per Share
3 unchanged sentences
Dollars except share and per share data):
−Removed: Net loss ( 113,918 ) ( 72,726 )
Weighted average number of ordinary shares
1 unchanged sentence
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.
+Added: This summary also gives an overview of all exercisable instruments generated by the company either through Financing or incentive programs for employees as described in Note 12.
+Added: Warrants Shares * Warrants Shares *
Non-employee warrants 107,008 107,008 244,693 244,693
3 unchanged sentences
Prefunded warrants 137,991,871 202,972,492 22,266,331 22,266,331
−Removed: Note 20 Events after the Close of the Fiscal Year
−Removed: On March 27, 2025, the company announced a financing of up to $ 306.9 million (€ 284.5 million), to Advance Viaskin® Peanut Patch Through Biologics License Application Submission and U.S.
−Removed: Commercial Launch, if Approved.
−Removed: The financing includes gross proceeds of $ 125.5 million (€ 116.3 million) received on April 7 2025 and up to $ 181.4 million (€ 168.2 million) in potential additional gross proceeds that may be received if all the warrants are exercised, subject to satisfaction of specified conditions.
−Removed: The VITESSE Phase 3 study hitting its primary endpoint will trigger an acceleration of the exercise period of some of the warrants.
−Removed: The ABSA Warrants will be exercisable from their respective date of issue until the earlier of (i) April 7, 2027 and (ii) 30 days following the publication by the Company of a press release announcing that the ongoing VITESSE trial of Viaskin peanut in 4-7 years old met the primary endpoint defined in the VITESSE study protocol, it being specified that (i) the primary measure of treatment effect will be the difference in response rates at Month 12 between active and placebo treatment groups, (ii) the primary analysis will be based on a 2-sided confidence interval ("CI") for the difference in response rates and (iii) the primary analysis must be positive according to the success criterion (lower bound of the 2-sided 95 % CI of the difference in response rates ≥ 15 %) (the "ABSA Warrant Exercise Period").
−Removed: The exercise of one (1) ABSA Warrant will give the right to subscribe to one point seventy-five ( 1.75 ) ABSA Warrant Shares at a price of € 1.5939 per ABSA Warrant
−Removed: The financing results in an immediate dilution of 22.4 % and a maximal dilution of up to 73.7 % of existing shareholders (on a non-diluted basis) if all the warrants in the offering are exercised in full.
−Removed: The financing consists of:
−Removed: • a share capital increase without preferential subscription rights reserved to categories of persons satisfying determined characteristics pursuant to the 24th resolution of the general meeting of shareholders of May 16, 2024 (the "2024 General Meeting") completed on April 7, 2025 for an amount of € 38 million, consisting of the issuance of (i) 34,090,004 new shares at a par value of € 0.10 (the "New Shares") each with warrants of the Company attached (the "ABSA Warrants", and together with the New Shares, the "ABSA") at a subscription price of € 1.1136 per ABSA and (ii) up to 59,657,507 additional new shares, if all the ABSA Warrants attached to the New Shares are exercised (the "ABSA Warrant Shares");
−Removed: • the issue through an offering reserved to categories of persons satisfying determined characteristics of 71,005,656 units (the “PFW-BS-PFW”) completed on April 7, 2025 for an amount of € 79 million at a subscription price of € 1.1136 per PFW-BS-PFW (of which € 1.1036 will have been prefunded on the issue date), each PFW-BS-PFW consisting of one pre-funded warrant to subscribe for one share of the Company (the "First Pre-Funded Warrants") and one warrant (the "BS Warrants") to subscribe to one second pre-funded warrants (the "Second Pre-Funded Warrants"), each of which entitles the holder to subscribe for 1.75 shares of the Company (the "Second PFW Shares"), allowing to issue up to 71,005,656 additional new shares if all the First Pre-Funded Warrants are exercised (the "First PFW Shares") and up to 124,259,898 additional new shares if all the Second Pre-Funded Warrants are exercised (the "Second PFW Shares", together with the ABSA Warrant Shares and the First Pre-Funded Warrant Shares, the "Warrant Shares", and together with the New Shares, the "Offered Shares"),
−Removed: (together, the "Offering").
−Removed: The net proceeds from the issue of the ABSA and the PFW-BS-PFW, together with existing cash and cash equivalents, will be mainly used in the following order of priority (i) for working capital and general corporate purposes, (ii) to finance the continued development of the Viaskin Peanut program, (iii) to finance the preparation and submission of a potential BLA and, (iv) to finance the readiness of a launch of Viaskin peanut in the US, if approved.
−Removed: As of the date of authorization of these financial statements the Company is in a process of assessing the accounting implications.
−Removed: Taking into account the net proceeds of $ 125.5 million (€ 116.3 million) received on April 7, 2025 from the issuance of the ABSA and the PFW-BS-PFW and based on its current operations, plans and assumptions, the Company estimates that it has sufficient balance of cash & cash equivalents to fund its operations into June 2026.
+Added: PFW 2022 13,116,331 13,116,331 22,266,331 22,266,331
+Added: BSA from ABSA (March 20205 PIPE Financing) 15,635,172 27,361,551
+Added: PFW1 from PFW-BS-PFW (March 20205 PIPE Financing) 38,234,712 38,234,712
+Added: BS from PFW-BS-PFW (March 20205 PIPE Financing) 35,348,260 61,859,455
+Added: PFW2 (March 20205 PIPE Financing) 35,657,396 62,400,443
+Added: 220,792,425 35,777,293
+Added: * The equivalent in shares
Note 19 Reportable Segment Disclosure
10 unchanged sentences
The Company’s R&D organization is primarily responsible for the development and registration efforts of Viaskin Peanut.
−Removed: The Company’s technical operations group is responsible for the development of manufacturing processes, supplying clinical drug product.
The Company is also supported by corporate staff functions.
−Removed: The Company’s Chief Executive Officer as the CODM manages and allocates resources to the operations of the total company by assessing the overall level of resources available and how to best allocate them to support the Company’s long-term company-wide strategic goals.
+Added: The Company’s Chief Executive Officer as the chief operating decision maker (“CODM”) manages and allocates resources to the operations of the total company by assessing the overall level of resources available and how to best allocate them to support the Company’s long-term company-wide strategic goals.
In making this decision, the CODM uses consolidated financial information for the purposes of evaluating performance, allocating resources, setting incentive compensation targets and planning and forecasting for future periods.
1 unchanged sentence
Segment assets provided to the CODM are consistent with those reported on the Consolidated Statement of Financial Position with particular emphasis on the Company's available liquidity including cash, cash equivalents.
+Added: Note 20 Events after the Close of the Fiscal Year
+Added: March 2025 PIPE Financing - January 16, 2026
+Added: The Company has received, the supplemental gross proceeds of $ 94 million (€ 81 million) resulting in the Full Exercise of the ABSA Warrants and BS Warrants Issued on its March 2025 Financing.
+Added: Manufacturing Supply Agreement - PSM “Peanut Source Material “ Fareva La Vallée - March 17, 2026
+Added: The Company entered into a the MS Agreement with FLV, under which FLV will manufacture and supply the PSM exclusively for DBV Technologies S.A.
+Added: during the agreement term.
+Added: The term is effective for a period of eight ( 8 ) years and can be renewed for a period of two ( 2 ) years.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.