dbvt-20250331

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

____________________

FORM 10-Q

____________________

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2025

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ______________ to _______________

Commission file number 001-36697

DBV TECHNOLOGIES S.A.

(Exact name of registrant as specified in its charter)

____________________


France			Not applicable
State or other jurisdiction of incorporation or organization			(I.R.S. Employer Identification No.)
107 Av. de la République			N/A
92320 Châtillon
(Address of principal executive offices)			(Zip Code)

Registrant’s telephone number, including area code +33 1 55 42 78 78

____________________

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

American Depositary Shares, each representing five ordinary shares, nominal value €0.10 per share

DBVT

The Nasdaq Stock Market LLC

Ordinary shares, nominal value €0.10 per share*

n/a

The Nasdaq Stock Market LLC

*Not for trading, but only in connection with the registration of the American Depositary Shares.

Securities registered pursuant to Section 12(g) of the Act: None.

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

☒ Yes ☐ No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

☒ Yes ☐ No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer

☐

Accelerated filer

☐

Non-accelerated filer

☒

Smaller reporting company

☒

Emerging growth company

☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).

☐ Yes ☒ No

As of April 30, 2025, the registrant had 136,948,872 ordinary shares, nominal value €0.10 per share, outstanding including treasury shares.

Table of contents


Part I	Financial information	2
Item 1	Condensed Consolidated Statements of Financial Position (Unaudited) as of March 31, 2025 and December 31, 2024	2
	Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) for the Three Months Ended March 31, 2025 and 2024	3
	Condensed Consolidated Statements of Cash Flows (Unaudited) for the Three Months Ended March 31, 2025 and 2024	4
	Condensed Consolidated Statements of Changes in Shareholders’ Equity (Unaudited) for the Three Months Ended March 31, 2025 and 2024	5
	Notes to the Condensed Consolidated Financial Statements (Unaudited)	6
Item 2	Management’s Discussion and Analysis of Financial Condition and Results of Operations	15
Item 3	Quantitative and Qualitative Disclosures About Market Risk	20
Item 4	Controls and Procedures	20
Part II	Other Information	21
Item 1	Legal Proceedings	21
Item 1A	Risk Factors	21
Item 2	Unregistered Sales of Equity Securities and Use of Proceeds	21
Item 3	Defaults Upon Senior Securities	22
Item 4	Mine Safety Disclosures	22
Item 5	Other Information	22
Item 6	Exhibits	22

Unless the context otherwise requires, we use the terms “DBV”, “DBV Technologies,” the “Company,” “we,” “us” and “our” in this Quarterly Report on Form 10-Q, or Quarterly Report, to refer to DBV Technologies S.A. and, where appropriate, its consolidated subsidiaries. “Viaskin®”, “EPIT™” and our other registered and common law trade names, trademarks and service marks are the property of DBV Technologies S.A. or our subsidiaries. All other trademarks, trade names and service marks appearing in this Quarterly Report are the property of their respective owners. Solely for convenience, the trademarks and trade names in this Quarterly Report may be referred to without the ® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert their rights thereto.

SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS

This Quarterly Report contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements may be identified by such forward-looking terminology as “may,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue” or variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Any forward-looking statement involves known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statement. Forward-looking statements include statements, other than statements of historical fact, about, among other things:

•our expectations regarding the timing or likelihood of regulatory filings and approvals, including with respect to our anticipated re-submission of a Biologics License Application (“BLA”) for Viaskin Peanut patch to the U.S. Food and Drug Administration (“FDA”);

•our expectations with respect to an actionable regulatory pathway, including an Accelerated Approval pathway, for toddlers ages 1-3 years-old for Viaskin Peanut patch;

•expectations regarding initiation of the confirmatory effectiveness study for Viaskin Peanut patch in 1 - 3 years-old;

•plans and expectations with respect to COMFORT Toddlers;

•anticipated support for the BLA re-submission for Viaskin Peanut patch to FDA;

•the timing and anticipated results of interactions with regulatory agencies;

•the design, initiation, timing, progress and results of our pre-clinical studies and clinical trials, and our research and development programs;

•the sufficiency of existing capital resources;

•the likelihood that warrants may be exercised following the disclosure of VITESSE topline results, should the results be positive;

•our business model and our other strategic plans for our business, product candidates and technology;

•our ability to manufacture clinical and commercial supplies of Viaskin Peanut and/or our other product candidates, if approved, and comply with regulatory requirements related to the manufacturing of our product candidates;

•our ability to build our own sales and marketing capabilities, or seek collaborative partners, to commercialize Viaskin Peanut and/or our other product candidates, if approved;

•the commercialization of our product candidates, if approved;

•our expectations regarding the potential market size and the size of the patient populations for Viaskin Peanut and/or our other product candidates, if approved, and our ability to serve such markets;

•the pricing and reimbursement of our product candidates, if approved;

•the rate and degree of market acceptance of Viaskin Peanut and/or our other product candidates, if approved, by physicians, patients, third-party payors and others in the medical community;

•our ability to advance product candidates into, and successfully complete, clinical trials;

•the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;

•estimates of our expenses, future revenues, capital requirements and our needs for additional financing;

•the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements;

•our ability to maintain and establish collaborations or obtain additional funding;

•our financial performance;

•expectations with respect to cash runway;

•developments relating to our competitors and our industry, including competing therapies; and

•other risks and uncertainties, including those listed under the caption “Risk Factors.”

Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report on Form 10-Q, these statements are based on our estimates or projections of the future that are subject to known and unknown risks and uncertainties and other important factors that may cause our actual results, level of activity, performance, experience or achievements to differ materially from those expressed or implied by any forward-looking statement. These risks, uncertainties and other factors are described in greater detail under the caption “Risk Factors” in Part I. Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on April 11, 2025. As a result of the risks and uncertainties, the results or events indicated by the forward-looking statements may not occur. Undue reliance should not be placed on any forward-looking statement. We qualify all of our forward-looking statements by these cautionary statements.

In addition, any forward-looking statement in this Quarterly Report, including statements that “we believe” and similar statements, reflect our beliefs and opinions on the relevant subject and represents our views only as of the date of this Quarterly Report and should not be relied upon as representing our views as of any subsequent date. These statements are based upon information available to us as of the date of this Quarterly Report and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to unduly rely upon these statements. We anticipate that subsequent events and developments may cause our views to change. Although we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, except as required by applicable law. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.

PART I – FINANCIAL INFORMATION

Item 1. Financial Statements

DBV Technologies S.A.

Condensed Consolidated Statements of Financial Position (unaudited)

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


	Note		March 31, 2025	December 31, 2024
Assets
Current assets :
Cash and cash equivalents	3	$	12,962	32,456
Other current assets	4		16,186	11,932
Total current assets			29,148	44,388
Property, plant, and equipment, net			10,813	11,306
Right-of-use assets related to operating leases	5		5,613	5,502
Intangible assets			29	40
Other non-current assets			4,960	4,423
Total non-current assets			21,414	21,271
Total Assets		$	50,562	65,658
Liabilities and shareholders' equity
Current liabilities:
Trade payables	6	$	34,146	22,032
Short-term operating leases	5		709	654
Current contingencies	9		82	122
Other current liabilities	6		5,447	8,328
Total current liabilities			40,384	31,136
Long-term operating leases	5		6,525	6,297
Non-current contingencies	9		780	838

Total non-current liabilities			7,305	7,135
Total Liabilities		$	47,688	38,271
Shareholders’ equity :
Ordinary shares, €0.10 par value; 102,858,868 and 102,847,501 shares authorized, and issued as at March 31, 2025 and December 31, 2024, respectively		$	11,652	11,651
Additional paid-in capital			317,313	315,613
Treasury stock, 230,513 and 266,868 ordinary shares as of March 31, 2025 and December 31, 2024, respectively, at cost			(1,263)	(1,309)
Accumulated deficit			(313,454)	(286,375)
Accumulated other comprehensive income			1,036	905
Accumulated currency translation effect			(12,411)	(13,097)
Total Shareholders’ equity	7	$	2,873	27,387
Total Liabilities and Shareholder's equity		$	50,562	65,658

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

DBV Technologies S.A.

Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)

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


	Note		Three Months Ended March 31,
				2025	2024
Operating income	10	$		753	1,407
Operating expenses	11
Research and development expenses				(21,483)	(21,403)
Sales and marketing expenses				(262)	(758)
General and administrative expenses				(5,626)	(7,804)
Total Operating expenses				(27,370)	(29,964)
Loss from operations				(26,618)	(28,558)
Financial income (expense)				(461)	1,261
Loss before taxes				(27,079)	(27,297)
Income tax				—	(48)
Net loss		$		(27,079)	(27,345)
Foreign currency translation differences, net of taxes				686	(3,026)
Actuarial gains / (losses) on employee benefits, net of taxes				132	(59)
Comprehensive loss		$		(26,261)	(30,429)
Basic/diluted Net loss per share attributable to shareholders	14	$		(0.26)	(0.28)
Weighted average shares outstanding used in computing per share amounts:				102,617,429	96,176,057

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

DBV Technologies S.A.

Condensed Consolidated Statements of Cash Flows (unaudited)

(amounts in thousands)


	Notes		Three Months Ended March 31,
			2025	2024
Net loss for the period		$	(27,079)	(27,345)
Adjustments to reconcile net loss to net cash (used in) operating activities:
Depreciation, amortization and accrued contingencies			952	53
Expenses related to share-based payments	8		1,702	1,958
Inventory write-downs			4,286	1,289
Other elements			465	(8)
Changes in operating assets and liabilities:
Decrease (increase) in inventories and work in progress			(4,286)	(1,289)

Decrease (increase) in other current assets			(3,662)	(835)
(Decrease) increase in trade payables			10,943	(4,805)
(Decrease) increase in other current and non-current liabilities			(3,104)	(3,765)
Change in operating lease liabilities and right of use assets			115	56
Net cash flow (used in) operating activities			(19,668)	(34,692)
Cash flows (used in) investing activities :
Change in property, plant, and equipment			(10)	(1,335)

Change in non-current financial assets			(366)	(797)

Net cash flows (used in) investing activities			(375)	(2,132)
Cash flows (used) / provided by financing activities :

Treasury shares			45	(62)



Net cash flows (used) / provided by financing activities			45	(62)

Effect of exchange rate changes on cash and cash equivalents			504	(2,957)
Net (decrease) / increase in cash and cash equivalents	3		(19,494)	(39,842)
Net Cash and cash equivalents at the beginning of the period			32,456	141,367
Net cash and cash equivalents at the end of the period		$	12,962	101,525

The Company now presents inventory write-downs separately from the “Decrease (Increase) in inventories and work in progress” line item. Comparative information has been updated accordingly to ensure consistency.

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

DBV Technologies S.A.

Condensed Consolidated Statements of Changes in Shareholders’ Equity (unaudited)

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


	Ordinary shares
	Number of Shares	Amount	Additional paid-in capital	Treasury stock	Accumulated deficit	Accumulated other comprehensive income (loss)	Accumulated currency translation effect	Total Shareholders’ Equity
Balance at January 1, 2024	96,431,770	10,972	377,468	(1,263)	(238,862)	742	(8,871)	140,187
Net (loss)	—	—	—	—	(27,345)	—	—	(27,345)
Other comprehensive income (loss)	—	—	—	—	—	(59)	(3,026)	(3,084)
Issuance of ordinary shares	2,599	—	—	—	—	—	—	—

Treasury shares	—	—	—	(62)	—	—	—	(62)
Share-based payments	—	—	1,958	—	—	—	—	1,958


Balance at March 31, 2024	96,434,369	10,972	379,426	(1,325)	(266,207)	683	(11,897)	111,654


	Ordinary shares
	Number of Shares	Amount	Additional paid-in capital	Treasury stock	Accumulated deficit	Accumulated other comprehensive income (loss)	Accumulated currency translation effect	Total Shareholders’ Equity
Balance at January 1, 2025	102,847,501	11,651	315,613	(1,309)	(286,375)	905	(13,097)	27,387
Net (loss)	—	—	—	—	(27,079)	—	—	(27,079)
Other comprehensive income (loss)	—	—	—	—	—	132	686	817
Issuance of ordinary shares	11,367	1	(1)	—	—	—	—	—

Treasury shares	—	—	—	46	—	—	—	46
Share-based payments	—	—	1,702	—	—	—	—	1,702


Balance at March 31, 2025	102,858,868	11,652	317,313	(1,263)	(313,454)	1,036	(12,411)	2,873

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

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

Note 1: The Company

Incorporated in 2002 under the laws of France, DBV Technologies S.A. (“DBV Technologies” or the “Company”) is a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin. The Company’s therapeutic approach is based on epicutaneous immunotherapy (“EPIT”), a proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin.

Basis of Presentation

The condensed consolidated financial statements of the Company and its wholly-owned subsidiaries are unaudited and have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) and are presented in U.S. dollars. All significant intercompany accounts and transactions between the Company and its subsidiaries have been eliminated on consolidation.

The unaudited condensed consolidated financial statements presented in this Quarterly Report should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K filed with the SEC on April 11, 2025 (the “ Annual Report”). The condensed consolidated statement of financial position as of December 31, 2024 was derived from the audited consolidated financial statements but does not include all disclosures required by U.S. GAAP. The Company’s critical accounting policies are detailed in the Annual Report. The Company’s critical accounting policies have not changed materially since December 31, 2024.

Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted from these interim financial statements. However, these condensed consolidated financial statements include all adjustments, consisting only of normal recurring adjustments, which are, in the opinion of management, necessary to fairly state the results of the interim period. These interim financial results are not necessarily indicative of results to be expected for the full fiscal year ending December 31, 2025, or any other future period.

Use of Estimates

The preparation of the Company’s condensed 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 condensed consolidated financial statements and the reported amount of income and expenses during the period. The Company bases its estimates and assumptions on historical experience and other factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis. The actual results may differ from these estimates.

On an on-going basis, management evaluates its estimates, primarily those related to: (1) research tax credits, (2) assumptions used in the valuation of right of use assets—operating lease, (3) impairment of right-of-use assets related to leases and property, plant and equipment, (4) recoverability of the Company’s net deferred tax assets and related valuation allowance, (5) assumptions used in the valuation model to determine the fair value and vesting conditions of share-based compensation plan, 6) estimate of contingencies and provisions, and (7) estimate of employee benefits obligations.

Going Concern

These Condensed Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business.

The Company has incurred operating losses and negative cash flows from operations since inception. The Company does not generate product revenue and continues to prepare for the potential launch of its first product in the United States and in the European Union, if approved.

Since its inception, the Company has primarily funded its operations through equity financings, as well as public assistance and Research Tax Credit.. Prior to 2022, the Company underwent restructuring efforts, scaled down certain clinical programs, and engaged with regulatory authorities to advance Viaskin Peanut’s approval process in the United States and European Union. In 2022, the Company secured a private placement financing of $194 million and lifted a partial clinical hold from the FDA on its VITESSE Phase 3 clinical study.

On April 7, 2025, the Company received gross proceeds of $125.5 million (€116.3 million) from the issuance of the ABSA and PFW-BS-PFW, as described in Note 15. With the receipt of the aforementioned proceeds, and based on its current operations, plans, and assumptions examined by the Board of Directors (“Board”) on March 23, 2025, the Company estimates that its cash and cash equivalents are sufficient to fund its operations into June 2026.

Given the Company’s historical operating losses and reliance on external financings, the Company may still seek additional capital for future needs through a combination of public or private equity or debt financings, collaborations, licensing agreements, and other funding options. While recent financing events have improved the Company’s financial position, access to additional capital in the future remains subject to market conditions and investor interest.

Accounting Pronouncements Recently Adopted

There have been no recently issued accounting standards adopted during the period which had a material impact on the Company’s financial statements.

There are no recently issued accounting standards that are expected to have a material impact on our results of operations, financial condition, or cash flows.

Accounting Pronouncements issued not yet adopted

In December 2023, the FASB issued ASU 2023-09, Income Taxes Topic 740 — Improvements to Income Tax Disclosures which enhances the transparency and usefulness of income tax disclosures. This amendment requires disclosure of disaggregated information about the Company’s effective tax rate reconciliation as well as information on income taxes paid. The disclosure requirements will be applied on a prospective basis, with the option to apply it retrospectively. For SEC filers, this ASU 2023-09 is effective for fiscal years beginning after December 15, 2024. The Company is currently evaluating the impact the adoption of this ASU will have on its consolidated financial statements and related disclosures.

In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income Topic 220 — Expense Disaggregation Disclosures. The guidance requires disclosure of additional information about specific expense categories in the notes to financial statements at interim and annual reporting periods. The disclosure requirements will be applied on a prospective basis, with the option to apply it retrospectively. For SEC filers, this ASU is effective for fiscal years beginning after December 15, 2026 and interim periods within fiscal years beginning after December 15, 2027. The Company is currently evaluating the impact the adoption of this ASU 2024-03 will have on its consolidated financial statements and related disclosures.

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

Note 2: Significant Events and Transactions

Clinical Programs

United States Regulatory History and Current Status

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

In August 2020, the Company received a Complete Response Letter (“CRL”) in which the FDA indicated it could not approve the Viaskin Peanut BLA in its then-current form. The FDA did not raise any safety concerns related to Viaskin Peanut.

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

In March 2021, the Company commenced CHAMP (Comparison of adHesion Among Modified Patches), a Phase 1 trial in healthy adult volunteers. . In May 2021, the Company submitted a proposed protocol to the FDA for STAMP (Safety, Tolerability, and Adhesion of Modified Patches)a 6-month safety and adhesion study which was to be conducted concurrently with DBV’s allergen uptake comparison studies (i.e., ‘EQUAL in Adults’, EQUAL). On October 14, 2021, in an Advice/Information Request letter, the FDA requested the Company conduct a stepwise, or sequential, approach to the modified Viaskin patch development program by conducting EQUAL first and submitting the data for FDA review and feedback prior to starting the STAMP study.

In December 2021, the Company decided not to pursue the sequential approach requested by the FDA and instead 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. Following written exchanges with the FDA, the FDA confirmed it was aligned with the Company’s strategy.

On September 7, 2022, the Company announced the initiation of VITESSE, a Phase 3 pivotal study of the mVP in children ages 4-7 years with peanut allergy. On September 21, 2022, the Company announced it received from FDA a partial clinical hold letter related to certain design elements of VITESSE.

On December 23, 2022, the Company announced that the FDA lifted the partial clinical hold The Company announced on September 23, 2024, that subject screening was completed in the third quarter of 2024. Topline results are anticipated in the fourth quarter of 2025.

In June 2022, the Company announced positive topline results from Part B of EPITOPE.

On April 19, 2023, the Company outlined the regulatory pathway for Viaskin Peanut in children 1 – 3 years old after the FDA confirmed in written responses to the Company’s Pre-BLA meeting request that the Company’s EPITOPE phase 3 study met the pre-specified criteria for success for the primary endpoint and did not request an additional efficacy study in this age group. The FDA required additional safety data to augment the safety data collected from EPITOPE in support of a BLA.

On July 31, 2023, the Company announced receipt of feedback from FDA on two supplemental safety studies, COMFORT Children and COMFORT Toddlers.

On November 9, 2023, the Company submitted the protocol for its COMFORT Toddlers supplemental safety study in 1 – 3 years-old to FDA. The Company received comments and queries to the protocol from the FDA on March 11, 2024. On July 30, 2024, the Company announced that it and the FDA had been engaged in ongoing dialogue since May 2023 on the COMFORT Toddlers supplemental safety study in 1 – 3 years-old with a peanut allergy.

The Company also announced on November 9, 2023, 2-year results from the ongoing phase 3 open-label extension to the EPITOPE trial, EPOPEX, of Viaskin Peanut in toddlers.

On October 22, 2024, the Company announced positive regulatory updates for the Viaskin Peanut patch in the United States and Europe. DBV had agreed to guidance provided by the FDA on a potential pathway under the Accelerated Approval Program for the Viaskin Peanut patch in toddlers ages 1 – 3 years-old. FDA confirmed that the Company has met Accelerated Approval qualifying criterion 1 and 2. Regarding criterion 3, FDA has provided guidance and suggestion regarding the intermediate clinical endpoint, which the Company agreed to in informal discussions with the FDA. The Company formalized the Accelerated Approval guidance provided by FDA via submission of a meeting request and confirmed the general elements of the two study components: the COMFORT Toddlers safety study, to be completed before BLA submission, and the confirmatory effectiveness study, including

the third Accelerated Approval criterion regarding the intermediate clinical endpoint. The Company expects that the confirmatory study will be initiated by the time of BLA submission and would run in parallel to commercialization in the United States, if Viaskin Peanut is approved.

The Company announced further that it has aligned with FDA on a wear time collection methodology in COMFORT Toddlers intended to generate sufficient data to support a BLA submission. DBV has initiated study start-up activities and plans to screen the first subject in the second quarter of 2025. The company anticipates enrolling approximately 300 – 350 subjects on active treatment into the safety study, which would bring the total Viaskin Peanut patch safety database in toddlers to approximately 600 subjects, consistent with prior FDA guidance. With this path forward, the BLA submission for Viaskin Peanut patch in 1 – 3 years-old under the Accelerated Approval program is anticipated to be supported by:

i. Positive efficacy and safety data from DBV’s previously completed EPITOPE Phase 3 Study; and

ii. Additional safety data generated in COMFORT Toddlers supplemental safety study to be initiated in the second quarter of 2025.

On December 11, 2024, the Company announced that it reached alignment with FDA on the Accelerated Approval pathway for Viaskin Peanut patch in toddlers 1 – 3 years-old and on key study design elements for the COMFORT Toddlers study, including study size and wear time collection methodology and analysis. The Company announced further that FDA confirmed criteria for a post-marketing confirmatory study in toddlers 1-3 years-old and that the Company and FDA agreed that the confirmatory study will assess the effectiveness of the intended commercial Viaskin Peanut patch, will include a double-blind, placebo-controlled food challenge (DBPCFC), will use the same statistical criteria for success (i.e., lower bound of the 95% CI > 15%) as used in the EPITOPE, and will need to be initiated at the time that the BLA is submitted.

The Company submitted the protocol for its COMFORT Children supplemental safety study in ages 4-through-7-years-old to the FDA on November 29, 2023. On March 24, 2025, the Company announced that in a Written Responses Only to the Company’s Type D IND meeting request the FDA agreed with the Company’s proposal that the safety exposure data from the VITESSE Phase 3 study for Viaskin peanut patch in 4-7-year-olds will be sufficient to support a BLA filing in this age group. As a result, the COMFORT Children supplemental safety study will no longer be required and the Company will not conduct the study. The Company will utilize the safety data from the VITESSE participants randomized to active treatment as well as placebo-crossover participants in the VITESSE Open Label Extension (OLE). Accordingly, the Company plans to submit a BLA in the first half of 2026 and anticipates potentially accelerating the product launch by approximately one year, subject to FDA approval.

Viaskin Peanut —European Union Regulatory History and Current Status

In November 2020, we announced that our Marketing Authorization Application, or MAA, for Viaskin Peanut, submitted under the name “Abylqis®”, had been validated by the European Medicines Agency, or EMA. The validation of the MAA confirmed that the submission was sufficiently complete to begin the formal review process for Viaskin Peanut to treat peanut allergies in children ages four to 11 years. Following the MAA validation, the EMA’s Committee for Medicinal Products for Human Use, or CHMP, reviews the application and provides a recommendation to the European Commission, on whether to grant a marketing authorization.

On August 2, 2021, we announced we had received from the EMA the Day 180 list of outstanding issues, which is an established part of the prescribed EMA review process. The EMA identified one Major Objection remained at Day 180n questioning the limitations of the data, for example, the clinical relevance and effect size supported by a single pivotal study.

On December 17, 2021, we announced we had withdrawn the MAA for Viaskin Peanut, submitted under the name “Abylqis”, and formally notified the EMA of our decision.

On October 22, 2024, the Company announced it received scientific advice from EMA on an indication for ages 1 – 7 years-old in Europe regarding the components of a MAA for the Viaskin Peanut patch. Previous advice obtained from two local country regulatory health authorities indicated a potential path for a 1 – 7 year-old registration with one patch, the modified patch. The EMA recently confirmed through scientific advice that the completed EPITOPE study in 1 – 3 years-old, and a positive VITESSE study in 4 – 7 years-old, could constitute an MAA submission for a 1 – 7 years-old indication for peanut allergy patients using the modified patch, along with a new safety study in toddlers ages 1 – 3 years-old with the modified patch. Timing for the initiation of this new safety study to satisfy the important EU market is currently being planned.

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

Viaskin Peanut for Children Ages 1 – 3

In June 2020, the Company announced that in Part A of the EPITOPE phase 3 clinical study subject in both treatment arms showed consistent treatment effects after 12 months of therapy, as assessed by a double-blind placebo-controlled food challenge and biomarker results. Part A subjects were not included in Part B and the efficacy analyses from Part A were not statistically powered to demonstrate superiority of either dose versus placebo.

In June 2022, the Company announced positive topline results from Part B of EPITOPE.

On April 19, 2023, the Company outlined the regulatory pathway for Viaskin Peanut in children 1 – 3 years old after the FDA confirmed in written responses to the Company’s Pre-BLA meeting request that the Company’s EPITOPE phase 3 study met the pre-specified criteria for success for the primary endpoint and did not request any additional efficacy study in this age group. The FDA requires additional safety data to augment the safety data collected from EPITOPE in support of a BLA. This new safety study will also generate patch adhesion data and will include updated instructions for use.

On May 10, 2023, the New England Journal of Medicine (“NEJM”) published results from the EPITOPE phase 3 clinical study that demonstrated EPIT with Viaskin Peanut was statistically superior to placebo in desensitizing children to peanut exposure by increasing the peanut dose that triggers allergic symptoms. As stated in an accompanying editorial piece, these data are seen as “very good news” for toddlers with peanut allergy.

In November 2023, the Company announced the interim analyses from the first year of the open-label extension of EPITOPE, called EPOPEX, which showed improvement between months 12 and 24 of treatment with Viaskin Peanut across all efficacy parameters. These data were presented at the annual American College of Allergy, Asthma and Immunology (ACAAI) in November 2023.

On October 22, 2024, the Company announced positive regulatory updates for the Viaskin Peanut patch in the United States and Europe. DBV agreed to guidance provided by the FDA on a potential pathway under the Accelerated Approval Program for the Viaskin Peanut patch in toddlers ages 1 – 3 years-old.

FDA confirmed that the Company has met Accelerated Approval qualifying criteria 1 and 2. Regarding criterion 3, FDA has provided guidance and suggestion regarding the intermediate clinical endpoint, which the Company has agreed to in informal discussions with the FDA. The Company formalized the Accelerated Approval guidance provided by FDA via submission of a meeting request and confirmed the general elements of the two study components: the COMFORT Toddlers safety study, to be completed before BLA submission, and the confirmatory effectiveness study, including the third Accelerated Approval criterion regarding the intermediate clinical endpoint. The Company expects that the confirmatory study will be initiated by the time of BLA submission and would run in parallel to commercialization in the United States, if Viaskin Peanut is approved.

The Company announced further that it has aligned with FDA on a wear time collection methodology in COMFORT Toddlers that provides a practical approach for subjects and families, is intended to generate sufficient data to support a BLA submission, and places wear time into an acceptable clinical hierarchy relative to other study endpoints. DBV has initiated study start-up activities and plans to screen the first subject in the second quarter of 2025. The company anticipates enrolling approximately 300 – 350 subjects on active treatment into the safety study, which would bring the total Viaskin Peanut patch safety database in toddlers to approximately 600 subjects, consistent with prior FDA guidance. With this path forward, the BLA submission for Viaskin Peanut patch in 1 – 3 years-old under the Accelerated Approval program is anticipated to be supported by:

i. Positive efficacy and safety data from DBV’s previously completed EPITOPE Phase 3 Study; and

ii. Additional safety data generated in COMFORT Toddlers supplemental safety study to be initiated in the second quarter of 2025.

On December 11, 2024, the Company announced that it reached alignment with FDA on the Accelerated Approval pathway for Viaskin Peanut patch in toddlers 1-3 years-old and on key study design elements for the COMFORT Toddlers study, including study size and wear time collection methodology and analysis. The Company announced further that FDA confirmed criteria for a post-marketing confirmatory study in toddlers 1-3 years-old and that the Company and FDA agreed that the confirmatory study will assess the effectiveness of the intended commercial Viaskin Peanut patch, will include a double-blind, placebo-controlled food challenge (DBPCFC), will use the same statistical criteria for success (i.e., lower bound of the 95% CI > 15%) as used in the EPITOPE, and will need to be initiated at the time that the BLA is submitted.

Viaskin Peanut for Children Ages 4 – 7

On September 7, 2022, the Company announced the initiation of VITESSE, a Phase 3 pivotal study of the mVP in children ages 4-7 years with peanut allergy. The Company defined initiation as the submission of the trial protocol to selected study sites for subsequent Institutional Review Board (IRB)/Ethics Committee (EC) approval.

On September 21, 2022, the Company announced it received from the FDA a partial clinical hold letter related to certain design elements of VITESSE. The Company announced on December 23, 2022 that the FDA lifted the partial clinical hold.The Company announced on September 23, 2024 that subject screening was completed in the third quarter of 2024. Topline results are anticipated in the fourth quarter of 2025.

In July 2023, the Company received Type C Meeting Written Responses from the FDA regarding key study design elements for COMFORT Children. Subsequently, in October 2023, the Company received feedback from the FDA addressing the remaining protocol design elements for COMFORT Children.

The Company submitted the protocol for its COMFORT Children supplemental safety study in 4--7-years-old to the FDA on November 29, 2023.On March 24, 2025, the Company announced that in a Written Responses Only to the Company’s Type D IND meeting request the FDA agreed with the Company’s proposal that the safety exposure data from the VITESSE Phase 3 study for Viaskin peanut patch in 4 – 7-year-olds will be sufficient to support a BLA filing in this age group. As a result, the COMFORT Children supplemental safety study will no longer be required and the Company will not conduct the study. The Company will utilize the safety data from the VITESSE participants randomized to active treatment as well as placebo-crossover participants in the VITESSE Open Label Extension (OLE). Accordingly, the Company plans to submit a BLA in the first half of 2026 and anticipates potentially accelerating the product launch by approximately one year, subject to FDA approval.

Financing

On March 27, 2025, the Company announced a financing of up to $306.9 million (€284.5 million), to advance the Viaskin Peanut Patch through BLA submission and U.S. commercial launch, if approved. The financing includes gross proceeds of $125.5 million (€116.3 million) received on April 7, 2025, and up to $181.4 million (€168.2 million) in potential additional gross proceeds that may be received if all the warrants are exercised, subject to satisfaction of specified conditions. The VITESSE Phase 3 study hitting its primary endpoint will trigger an acceleration of the exercise period of some of the warrants. The ABSA Warrants (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 Viaskin Peanut in children 4-7 years old met the primary endpoint defined in the VITESSE study protocol, it being specified that (i) the primary measure of treatment effect will be the difference in response rates at Month 12 between active and placebo treatment groups, (ii) the primary analysis will be based on a 2-sided confidence interval (“CI”) for the difference in response rates, and (iii) the primary analysis must be positive according to the success criterion (lower bound of the 2-sided 95% CI of the difference in response rates ≥ 15%) (the “ABSA Warrant Exercise Period”). The exercise of one (1) ABSA Warrant will give the holder the right to subscribe to one point seventy-five (1.75) ABSA Warrant Shares at a price of €1.5939 per ABSA Warrant.

The financing 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.

The financing consists of:

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

prefunded on the issue date), each PFW-BS-PFW consisting of one pre-funded warrant to subscribe for one share of the Company (the "First Pre-Funded Warrants") and one warrant (the "BS Warrants") to subscribe to one second pre-funded warrants (the "Second Pre-Funded Warrants"), each of which entitles the holder to subscribe for 1.75 shares of the Company (the "Second PFW Shares"), allowing to issue up to 71,005,656 additional new shares if all the First Pre-Funded Warrants are exercised (the "First PFW Shares") and up to 124,259,898 additional new shares if all the Second Pre-Funded Warrants are exercised (the "Second PFW Shares", together with the ABSA Warrant Shares and the First Pre-Funded Warrant Shares, the "Warrant Shares", and together with the New Shares, the "Offered Shares"),

(together, the "Offering").

The net proceeds from the issue of the ABSA and the PFW-BS-PFW, together with existing cash and cash equivalents, will be mainly used by the Company 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 U.S., if approved.

The ordinary shares, including the ordinary shares issuable upon exercise of the warrants from the Offering, have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the ordinary shares, including the ordinary shares underlying the warrants issued as part of the Offering.

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.

Legal Proceedings

From time to time, the Company may become subject to various legal proceedings and claims that arise in the ordinary course of our business activities. The Company is not currently subject to any material legal proceedings.

Note 3: Cash and Cash Equivalents

The following tables summarize the cash and cash equivalents as of March 31, 2025 and December 31, 2024:


	March 31, 2025	December 31, 2024
Cash	12,962	32,456
Cash equivalents	—	—
Total cash and cash equivalents as reported in the statements of financial position	12,962	32,456

Note 4: Other Current Assets

Other current assets consisted of the following:


	March 31, 2025	December 31, 2024
Research tax credit	4,917	3,980
Other tax claims	6,015	4,452
Prepaid expenses	3,875	1,541
Other receivables	1,380	1,959
Total	16,186	11,932

Research tax credit

The variance in Research Tax Credit is presented as follows:


			Amount in thousands of US dollars
Opening research tax credit receivable as of January 1, 2025			3,980
+ Operating revenue			753

- Adjustment and currency translation effect			184
Closing research tax credit receivable as of March 31, 2025			4,917
Of which - Non-current portion			—
Of which - Current portion			4,917

Before currency translation effect, the balance in research tax credit as of March 31, 2025, consisted of $4.0 million research tax credit for the previous fiscal year filed with the tax authorities. The estimated research tax credit for the first three months of the 2025 fiscal year amounts to $0.8 million.

The other tax claims are primarily related to the VAT as well as the reimbursement of VAT that has been requested. Prepaid expenses are comprised primarily of insurance expenses, as well as legal and scientific consulting fees.

Note 5: Lease contracts

Future minimum lease payments under the Company’s operating leases’ right of use as of March 31, 2025 and December 31, 2024, are as follows:


	March 31, 2025					December 31, 2024
	Real Estate		Other assets		Total	Real Estate		Other assets		Total
Current portion	1,015		76		1,091	810		26		836
Year 2	1,259		56		1,315	1,222		7		1,228
Year 3	1,267		7		1,274	1,230		7		1,237
Thereafter	4,990		7		4,997	5,127		9		5,136
Total minimum lease payments	8,531		146		8,677	8,388		49		8,437
Less: Effects of discounting	(1,430)		(13)		(1,443)	(1,463)		(23)		(1,486)
Present value of lease liabilities	7,101		133		7,234	6,925		26		6,951
Less: current portion	(643)		(66)		(709)	(648)		(6)		(654)
Long-term lease liabities	6,459		66		6,525	6,278		20		6,297
Weighted average remaining lease term (years)	7.34		0.04			7.49		0.02
Weighted average discount rate	5.06	%	0.09	%		5.02	%	0.02	%

The Company recognizes rent expense, calculated as the remaining cost of the lease allocated over the remaining lease term on a straight-line basis. Rent expense presented in the consolidated statement of operations and comprehensive loss was:


	March 31,
	2025	2024
Operating lease expense / (income)	288	586
Net termination impact		49
Net restructuring impact	(1)	(7)

Supplemental cash flow information related to operating leases is as follows for the period March 31, 2025 and 2024:


	March 31,
	2025	2024
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows used in operating leases	96	501

Note 6: Trade Payables and Other Liabilities

6.1 Trade Payables

Trade payables increased by $12.1 million as of March 31, 2025, compared to December 31, 2024.

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

6.2 Other Liabilities

The following tables summarize the other liabilities as of March 31, 2025 and December 31, 2024:


	March 31, 2025			December 31, 2024
	Other current liabilities	Other non-current liabilities	Total	Other current liabilities	Other non-current liabilities	Total
Employee related liabilities	4,844	—	4,844	7,294	—	7,294

Tax liabilities	332	—	332	188	—	188
Other debts	272	—	272	846	—	846
Total	5,447	—	5,447	8,328	—	8,328

The Employee related liabilities include short-term debt to employees including social welfare, tax agency obligations and bonus provision. The variance versus year end is due to bonus accruals.

Note 7: Shareholders’ equity

The share capital as of March 31, 2025 is set at the sum of €10,285,887 ($11,652 thousand converted at historical rates). It is divided into102,858,868 fully authorized, subscribed and paid-up ordinary shares with a par value of €0.10.

Note 8: Share-Based Payments

The Board of Directors has been authorized at 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”).

During the three months ended March 31, 2025, the Company granted neither stock options nor restricted stock units to employees.

There have been no changes in the vesting conditions and method of valuation of the SO and RSUs from that disclosed in Note 12 to the consolidated financial statements included in the Annual Report.

Change in Number of BSA/SO/RSU:


	Number of outstanding
	BSA	SO	RSUs
Balance as of December 31, 2024	244,693	10,444,803	2,813,366
Granted during the period	—	—	—
Forfeited during the period	—	(3,725)	(36,350)
Exercised/released during the period	—	—	(20,467)
Expired during the period	—	—	—
Balance as of March 31, 2025	244,693	10,441,078	2,756,549

Share-based payments expense reflected in the condensed consolidated statements of operations is as follows:


		Three Months Ended March 31,
			2025	2024
Research & development	SO		(382)	(513)
	RSU		(199)	(256)
Sales & marketing	SO		(12)	(23)
	RSU		(6)	(9)
General & administrative	SO		(997)	(1,030)
	RSU		(105)	(126)
Total share-based compensation (expense)			(1,701)	(1,958)

Note 9: Contingencies

The following tables summarize the contingencies as of March 31, 2025 and December 31, 2024:


	March 31, 2025	December 31, 2024
Current contingencies	82	122
Non-current contingencies	780	838
Total contingencies	861	961

The changes in contingencies are as follows:


	Pension retirement obligations	Other contingencies	Total
At January 1, 2025	838	122	961
Increases in liabilities	34	21	55
Used liabilities	—	(63)	(63)
Reversals of unused liabilities	—	—	—
Net interest related to employee benefits, and unwinding of discount	—	—	—
Actuarial gains and losses on defined-benefit plans	(132)	—	(132)
Currency translation effect	39	1	41
At March 31, 2025	780	82	861
Of which current	—	82	82
Of which non-current	780	—	780

The Company does not hold any plan assets related to long-term employee benefit for any of the periods presented. There have been no significant changes in assumptions for the estimation of the retirement commitments from those disclosed in Note 13 to the consolidated financial statements included in the Annual Report.

Note 10: Operating income

The following table summarizes the operating income during the three and nine months ended March 31, 2025 and 2024:


	Three Months Ended March 31,
	2025	2024
Research tax credit	753	1,407

Other operating income	—	—
Total	753	1,407

The decrease in Research tax credit was primarily due to the fact that a greater proportion of studies activities were carried out in North America and were therefore not eligible to the French Research tax credit.

Note 11: Operating Expenses

The Company had an average of 106 employees during the three months ended March 31, 2025, in comparison with an average of 105 employees during the three months ended March 31, 2024. The increase is mainly due to hiring to support development activities and quality activities.

The following table summarizes the allocation of personnel expenses by function during the three months ended March 31, 2025 and 2024:


	Three Months Ended March 31,
	2025	2024
Research and Development expenses	4,630	5,048
Sales & Marketing expenses	155	334
General & Administrative expenses	2,996	3,236
Total personnel expenses	7,782	8,618

The following table summarizes the allocation of personnel expenses by nature during the three months ended March 31, 2025 and 2024:


	Three Months Ended March 31,
	2025	2024
Wages and salaries	4,677	5,144
Social security contributions	1,370	1,207
Expenses for pension commitments	34	309
Share-based payments	1,702	1,958
Total	7,782	8,618

The decrease in personnel expenses is primarily due to lower bonuses paid in 2025 compared to last year.

Note 12: Commitments

There were no significant changes in other commitments from those disclosed in Note 17 to the consolidated financial statements included in the Annual Report.

Note 13: Relationships with Related Parties

There were no new significant related-party transactions during the period nor any changes in the nature of the transactions from those described in Note 18 to the consolidated financial statements included in the Annual Report.

Note 14: Loss Per Share

Basic loss per share is calculated by dividing the net loss attributable to the shareholders of the Company by the weighted average number of ordinary shares outstanding during the period. As the Company was in a loss position for each of the three-month periods ended March 31, 2025 and 2024, the diluted loss per share is equal to basic loss per share because the effects of potentially dilutive shares were anti-dilutive as a result of the Company’s net loss.

The following is a summary of the ordinary share equivalents that were excluded from the calculation of diluted net loss per share for each of the three months period ended March 31, 2025 and 2024 indicated in number of potential shares:


	Three Months Ended March 31,
	2025	2024
Non-employee warrants	244,693	244,693

Stock options	10,492,903	7,388,016
Restricted stock units	3,087,872	2,064,035
Prefunded warrants	22,266,331	28,276,331

Note 15: Events after the Close of the Period

On March 27, 2025, the company announced a financing of up to $306.9 million (€284.5 million), to advance Viaskin® Peanut Patch through biologics license application submission and U.S. commercial launch, if approved. The financing includes gross proceeds of $125.5 million (€116.3 million) received on April 7, 2025 and up to $181.4 million (€168.2 million) in potential additional gross proceeds that may be received if all the warrants are exercised, subject to satisfaction of specified conditions.

On April 15, 2025, the Company received the 2024 Research Tax Credit (Crédit d’Impôt Recherche) in the amount of $4.0M in cash.

Note 16: Reportable segment disclosure


	Three Months Ended March 31,
	2025	2024
Clinical studies	6,802	8,173
BLA & Regulatory	1,385	1,480
Medical Affairs & Other Medical	1,958	2,664
Research & Innovation	744	190
Manufacturing & Supply and Quality	10,594	8,896
Sales & Marketing	262	758
General & Administrative	5,626	7,804
Total expenses	27,371	29,965

The Company operates and is managed as one operating segment driving expenses for the development of Viaskin Peanut. The Company’s R&D organization is primarily responsible for the development and registration efforts of Viaskin Peanut. The Company’s technical operations group is responsible for the development of manufacturing processes, supplying clinical drug product. The Company is also supported by corporate staff functions.

The Company’s Chief Executive Officer as the CODM manages and allocates resources to the operations of the total company by assessing the overall level of resources available and how to best allocate them to support the Company’s long-term company-wide strategic goals. In making this decision, the CODM uses consolidated financial information for the purposes of evaluating performance, allocating resources, setting incentive compensation targets and planning and forecasting for future periods.

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

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed consolidated financial statements and related notes included in Part 1, Item 1 of this Report and with our audited financial statements and related notes thereto for the year ended December 31, 2024, included in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on April 11, 2025, or the Annual Report. This discussion and other parts of this Report contain forward-looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations and intentions. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause such differences are discussed in the section of this Report titled “Special Note Regarding Forward-Looking Statements” and under “Item 1A. Risk Factors” in the Annual Report.

Overview

We are a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin. Our therapeutic approach is based on epicutaneous immunotherapy (EPIT) our proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin, an epicutaneous patch (i.e., a skin patch). We have generated significant data demonstrating that Viaskin’s mechanism of action is novel and differentiated, Viaskin targets specialized antigen-presenting immune cells in the skin, called Langerhans cells, that capture the antigen that accumulates in the outer layer of the skin, and then migrate to the skin-draining lymph nodes in order to activate the immune system without passage of the antigen into the bloodstream, minimizing systemic exposure in the body. We are advancing this unique technology to treat children suffering from food allergies, for whom safety is paramount, since the introduction of the offending allergen into their bloodstream can cause severe or life-threatening allergic reactions, such as anaphylactic shock. We believe Viaskin may offer convenient, self-administered, non-invasive immunotherapy to patients, if approved.

Our most advanced product candidate is Viaskin Peanut, evaluated as a potential immunotherapy for children with peanut allergy in eleven clinical trials, including four Phase 2 trials and four completed Phase 3 trials. We are advancing two separate Viaskin Peanut product candidates in parallel to support two potential Biologics License Applications (BLAs) in two distinct age groups: one in toddlers ages one through three with the original (square) patch, and one in children ages four through seven with the modified (circular) patch.

Currently, we have an ongoing Phase 3 efficacy and safety trial (VITESSE) to evaluate the modified Viaskin Peanut patch in children ages four through seven with peanut allergy. On March 7, 2023, the Company announced that the first subject was screened in the VITESSE study. The Company announced on September 23, 2024 that subject screening was completed in the third quarter of 2024. Topline results are anticipated in the fourth quarter of 2025. On March 24, 2025, the Company announced that in a Written Responses Only to the Company’s Type D IND meeting request the FDA agreed with the Company’s proposal that the safety exposure data from the VITESSE Phase 3 study for Viaskin peanut patch in 4 – 7-year-olds will be sufficient to support a BLA filing in this age group. As a result, the COMFORT Children supplemental safety study will no longer be required and the Company will not conduct the study. The Company will utilize the safety data from the VITESSE subjects randomized to active treatment as well as placebo-crossover subjects in the VITESSE Open Label Extension (OLE). Accordingly, the Company plans to submit a BLA in the first half of 2026 and anticipates potentially accelerating the product launch by approximately one year, subject to FDA approval.

We also have an ongoing Phase 3 open-label extension to the EPITOPE trial (our completed Phase 3 efficacy and safety trial conducted in peanut-allergic toddlers which met its clinical endpoints), with 3-year results for active-treatment subjects in 2024, as well as a planned Phase 3 supplementary safety study, in peanut-allergic toddlers ages one through three. The Company submitted the protocol for its COMFORT Toddlers supplemental safety study in 1 – 3 years-old to the FDA on November 9, 2023. The Company received comments and queries to the protocol from the FDA on March 11, 2024.

On July 30, 2024, the Company announced that it and the FDA had been engaged in ongoing dialogue since May 2023 on the COMFORT Toddlers supplemental safety study in 1 – 3-years-old with a peanut allergy. The study protocol was submitted on November 9, 2023, with comments provided by FDA on March 11, 2024. Since March, much of the dialogue between DBV and FDA regarding the COMFORT Toddlers supplemental study had focused on patch wear-time experience, including how prescribers would advise parents and caregivers to manage day-to-day variability in patch wear time. The Company proposed an approach, informed by the EPITOPE efficacy data, that focuses on the user experience during the first 90-days of treatment. The Company submitted to the FDA draft labeling for Section 2 – Dosing and Administration, for a potential Viaskin Peanut Prescribing Information (PI), along with comprehensive supportive data and analyses. Within the first 90-days of treatment (excluding the lead-in dosing period) it is possible to identify those patients who are very likely to have a robust clinical efficacy response based on patch wear time experience (i.e., “Label-in” patients). The proposed PI recommends continuation of treatment for these patients. With the same 90-day approach, patients less likely to have a robust clinical efficacy response, identified by their patch wear-time experience, would be identified as “Label-out” patients. In these instances, the PI would recommend a shared decision-making process, between the health care provider and the parent or caregiver, to determine whether treatment should be discontinued.

On October 22, 2024, the Company announced positive regulatory updates for the Viaskin Peanut patch in the United States and Europe. DBV has agreed to guidance provided by the FDA on a potential pathway under the Accelerated Approval Program for the Viaskin Peanut patch in toddlers ages 1 – 3 years-old. FDA confirmed that the Company has met Accelerated Approval qualifying criterion 1 and 2 . Regarding criterion 3, FDA has provided guidance and suggestion regarding the intermediate clinical endpoint, which the Company agreed to in informal discussions with the FDA. The Company formalized the Accelerated Approval guidance provided by FDA via submission of a meeting request and confirmed the general elements of the two study components: the COMFORT Toddlers safety study, to be completed before BLA submission, and the confirmatory effectiveness study, including the third Accelerated Approval criterion regarding the intermediate clinical endpoint. The Company expects that the confirmatory study will be initiated by the time of BLA submission and would run in parallel to commercialization in the United States, if Viaskin Peanut is approved.

The Company announced further that it has aligned with FDA on a wear time collection methodology in COMFORT Toddlers that provides a practical approach for subjects and families, is intended to generate sufficient data to support a BLA submission, and places wear time into an acceptable clinical hierarchy relative to other study endpoints. DBV has initiated study start-up activities and plans to screen the first subject in the second quarter of 2025. The Company anticipates enrolling approximately 300 – 350 subjects on active treatment into the safety study, which would bring the total Viaskin Peanut patch safety database in toddlers to approximately 600 subjects, consistent with prior FDA guidance. With this path forward, the BLA submission for Viaskin Peanut patch in 1 – 3 years-old under the Accelerated Approval program is anticipated to be supported by:

i. Positive efficacy and safety data from DBV’s previously completed EPITOPE Phase 3 Study; and

ii. Additional safety data generated in COMFORT Toddlers supplemental safety study to be initiated in the second quarter of 2025.

On December 11, 2024, the Company announced that it reached alignment with FDA on the Accelerated Approval pathway for Viaskin Peanut patch in toddlers 1-3 years-old and on key study design elements for the COMFORT Toddlers study, including study size and wear time collection methodology and analysis. The Company announced further that FDA confirmed criteria for a post-marketing confirmatory study in toddlers 1-3 years-old and that the Company and FDA agreed that the confirmatory study will assess the effectiveness of the intended commercial Viaskin Peanut patch, will include a include a double-blind, placebo-controlled food challenge (DBPCFC) and will use the same statistical criteria for success (i.e., lower bound of the 95% CI > 15%) as used in the EPITOPE and will need to be initiated at the time that the BLA is submitted.

The Company announced further that it sought scientific advice from the EMA regarding the components of a MAA for the Viaskin Peanut patch. Previous advice obtained from two local country regulatory health authorities indicated a potential path for a 1 – 7 year-old registration with one patch, the modified patch. The EMA recently confirmed through scientific advice that the completed EPITOPE study in 1 – 3 years-old, and a positive VITESSE study in 4 – 7 years-old, could constitute an MAA submission for a 1 – 7 year-old indication for peanut allergy patients using the modified patch, along with a new safety study in 1 – 3 years-old with the modified patch. Timing for the initiation of this new safety study to satisfy the important EU market is currently being planned.

Critical Accounting Policies and Significant Judgments and Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States(“U.S. GAAP”). The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements, as well as the revenue, costs and expenses recognized during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

There have been no new policies or significant changes to our critical accounting policies as disclosed in the critical accounting policies described in the Annual Report. Our significant accounting policies are more fully described in Note 1 of the Notes to the Consolidated Financial Statements in Part I, Item 1 of our Annual Report.

Business Trends and Results of Operations

Comparison of the Three Months Ended March 31, 2025 and 2024

The following table summarizes our results of operations, derived from our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in thousands of U.S. dollars, for the three months ended March 31, 2025 and 2024.


	Three Months Ended March 31,
	2025	2024	$ change	% of change
Operating income	753	1,407	(654)	(46)	%
Operating expenses
Research and development expenses	(21,483)	(21,403)	(80)	—	%
Sales and marketing expenses	(262)	(758)	496	(65)	%
General and administrative expenses	(5,626)	(7,804)	2,178	(28)	%
Total Operating expenses	(27,370)	(29,964)	2,594	(9)	%
Financial income (expense)	(461)	1,261	(1,722)	(137)	%
Income tax	0	-48	48	(100)	%
Net loss	(27,079)	(27,345)	267	(1)	%
Basic/diluted Net loss per share attributable to shareholders	(0.26)	(0.28)

Operating Income

The following table summarizes our operating income during the three months ended March 31, 2025 and 2024:


	Three Months Ended March 31,
	2025	2024	$ change	% of change
Sales	—	—	—	—	%
Other income	753	1,407	(654)	(46)	%
Research tax credit	753	1,407	(654)	(46)	%
Other operating income	—	—	—	—	%
Total operating income	753	1,407	(654)	(46)	%

Research tax credit decreased by $0.7 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024 primarily due to a greater proportion of studies activities carried out in North America and therefore not eligible to the French Research tax credit.

Operating Expenses

Research and Development Expenses

The following table summarizes our research and development expenses incurred during the three months ended March 31, 2025 and 2024:


Research and Development expenses	Three Months Ended March 31,
	2025	2024	$ change	% of change
External clinical-related expenses	13,957	14,026	(69)	—	%
Employee-related costs	4,050	4,278	(228)	(5)	%
Share-based payment expenses	581	770	(189)	(25)	%
Depreciation, amortization and other costs	2,895	2,329	566	24	%

Total Research and Development expenses	21,483	21,403	80	—	%

Research and Development expenses remain stable for the three months ended March 31, 2025 compared to the three months ended March 31, 2024 in particular for external clinical-related expenses given the continuity of efforts made on VITESSE Phase 3 clinical trial.

Employee-related costs, excluding share-based payments, decreased by $0.2 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024 due to lower bonuses paid in 2025 compared to 2024.

Depreciation, amortization and other costs increased by $0.6 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024 primarily as a result of a favorable reversal on accrual by $0.8 million due to the termination of the Collaboration Agreement with NESTEC in October 2023.

Sales and Marketing Expenses

The following table summarizes our sales and marketing expenses incurred during the three months ended March 31, 2025 and 2024:


Sales & Marketing expenses	Three Months Ended March 31,
	2025	2024	$ change	% of change

External professional services	105	192	(87)	(45)	%
Employee-related costs	137	302	(165)	(55)	%
Share-based payment expenses	18	32	(14)	(44)	%
Depreciation, amortization and other costs	2	232	(230)	(99)	%
Total Sales & Marketing expenses	262	758	(496)	(65)	%

Sales and marketing expenses have decreased by $0.5 million during the three months ended March 31, 2025, compared to the three months ended March 31, 2024 due operating expenses containment in the first quarter of 2025, including lower bonuses paid in 2025 compared to 2024.

General and Administrative Expenses

The following table summarizes our general and administrative expenses incurred during the three months ended March 31, 2025 and 2024:


General & Administrative expenses	Three Months Ended March 31,
	2025	2024	$ change	% of change
External professional services	1,052	2,433	(1,380)	(57)	%
Employee-related costs	1,893	2,080	(186)	(9)	%
Share-based payment expenses	1,103	1,157	(54)	(5)	%
Depreciation, amortization and other costs	1,577	2,135	(558)	(26)	%
Total General & Administrative expenses	5,626	7,804	(2,178)	(28)	%

General and Administrative expenses decreased by $2.2 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024.

External professional services decreased by $1.4 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024 mainly due to (1) one-time costs associated with financing activities, lower lease costs following office moves in France and the U.S, and trademark and patent activities that all occurred last year, and (2) a containment of costs and expenses during the Company’s financing period ended in March 31, 2025.

Employee-related costs, excluding share-based payments, decreased by $0.186 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024 due to lower bonuses paid in 2025 compared to last year.

Depreciation, amortization and other costs decreased by $0.6 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024 as a result of a lower lease cost in France.

Financial Income (Expense)

Our financial expense was $0.5 million for the three months ended March 31, 2025, compared to a financial income of $1.3 million for the three months ended March 31, 2024. This item mainly includes the financial income on our financial assets and foreign exchange result.

Income Tax

Our income tax expense was nil for the three months ended March 31, 2025 compared to $48 thousand for the three months ended March 31, 2024.

Net Loss

Net loss was $27.1 million for the three months ended March 31, 2025, compared to $27.3 million for the three months ended March 31, 2024. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.26 and $0.28 for the three months ended March 31, 2025 and 2024, respectively.

Liquidity and Capital Resources

Financial Condition

On March 31, 2025, we had $13.0 million in cash and cash equivalents compared to $32.5 million of cash and cash equivalents on December 31, 2024.

On March 27, 2025, the Company announced the 2025 PIPE, as further described below, of up to $306.9 million (€284.5 million), to advance Viaskin® Peanut Patch through BLA submission and U.S. commercial launch, if approved. The financing included gross proceeds of $125.5 million (€116.3 million) received on April 7 2025. 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.

Sources of Liquidity and Material Cash Requirements

On March 27, 2025, the Company entered into securities purchase agreements (together, the “Securities Purchase Agreements”) pursuant to which the Company agreed to issue and sell to Investors in a private placement (the “2025 PIPE”) the following securities:

•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"). The Company has assessed the PFW-BS-PFW will be classified as a component of permanent equity

The Company received initial gross proceeds of $125.5 million (€116.3 million) on April 7, 2025, and based on our current operations, plans and assumptions, we estimate that our balance of cash and cash equivalents will be sufficient to fund our operations into June 2026. We further estimate that, following the potential issuance of all Warrant Shares in the financing, representing potential additional gross proceeds of up to $181.4 million (€168.2 million), we could extend our financial visibility into 2028 and through potential commercialization of Viaskin Peanut in the U.S, if approved.

In May 2022, we established an At-The-Market (“ATM”) program to offer and sell, including with unsolicited investors who have expressed an interest, a total gross amount of up to $100 million of American Depositary Shares (“ADSs”), each ADS representing one-half of one ordinary share of the Company. The ATM program terminated on July 16, 2024 at the time the Company’s existing registration statement registering the ADSs to be issued under the ATM program expired.

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 $15.3 million on May 4, 2022, and of $7.8 million on June 14, 2023. Respectively, 6,036,238 and 2,052,450 new Ordinary Shares in the form of ADSs were 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 and $1.90 per ADS, each ADS giving the right to receive one-half of one ordinary share of the Company.

We have incurred net losses each year since our inception. Substantially all of our net losses resulted from costs incurred in connection with our development programs and from general and administrative expenses associated with our operations. We have not incurred any bank debt.

We may seek additional capital as we prepare for the launch of Viaskin Peanut, if approved, and continue other research and development efforts. We may seek to finance our future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of non-dilutive financings.

We cannot guarantee that we will be able to obtain the necessary financing to meet our needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets due any future pandemics, epidemics or global health crises and conflict in Ukraine or other global political or military crises. A severe or prolonged economic downturn could result in a variety of risks to us, including reduced ability to raise additional capital when needed or on acceptable terms, if at all. If we are not successful in our financing objectives, we could have to scale back our operations, notably by delaying or reducing the scope of our research and development efforts or obtain financing through arrangements with collaborators or others that may require us to relinquish rights to our product candidates that we might otherwise seek to develop or commercialize independently.

Operating Leases

Our corporate headquarters are located in Châtillon, France. Our principal offices occupy a 2,447 square meters facility, pursuant to a lease agreement dated November, 2023 and represents $6.7 million cash requirement as of March 31, 2025. The lease term ends in March, 2033.

The lease agreement for the former office occupying 4,470 square meters facility in Montrouge, France, signed on March 3, 2015, with an effective date of August 1, 2015, expired on May 31, 2024. Associated lease termination costs were reflected in the Company’s financial accounts in the Annual Report.

Our primary U.S. office is located in Warren, New Jersey. In February 2024, we entered into a sublease agreement, commencing on March 19, 2024 and effective for 70 months, for an office of 16,704 square feet in Warren, New Jersey. The Warren office represent a $1.7 million cash requirement as of March 31, 2025 which expires December 31, 2029.

We also have facilities in North America that were intended to support our U.S. operations. We lease 5,799 square feet in Basking Ridge, New Jersey, which commenced on April 1, 2022 and is effective for 38 months.The Basking Ridge office represents a $26 thousand cash requirement as of March 31, 2025 which expires April 30, 2025.

The Company transitioned to its new offices location in Warren NJ and Châtillon France in April 2024.

There have been no material changes in our operating leases from those disclosed in the Annual Report.

Purchase Obligations - Obligations Under the Terms of CRO Agreements

In preparation of the launch of our clinical trials for Viaskin Peanut, we signed agreements with several contract research organizations. As of March 31, 2025 expenses associated with the ongoing trials amounted globally to $180.0 million compared to $170.3 million as of December 31, 2024.

There have been no material changes in our purchase obligations from those disclosed in our Annual Report.

Summary Statement of Cash Flows

The table below summarizes our sources and uses of cash for the three months ended March 31, 2025 and 2024.


	Three Months Ended March 31,
(Amounts in thousands of U.S. Dollars)	2025	2024	$ change	% of change
Net cash flow used in operating activities	(19,668)	(34,692)	15,024	(43)	%
Net cash flow used in investing activities	(375)	(2,132)	1,756	(82)	%
Net cash flow used / provided by financing activities	45	(62)	107	(174)	%
Effect of exchange rate changes on cash and cash equivalents	504	(2,957)	3,461	(117)	%
Net (decrease) increase in cash and cash equivalents	(19,494)	(39,842)	20,348	(51)	%

Operating Activities

Our net cash flows used in operating activities were $19.7 million and $34.7 million during the three months ended March 31, 2025 and 2024, respectively. Our net cash flows used in operating activities decreased by $15.0 million as our costs and expenses have been contained during the Company’s financing period ended in March 31, 2025.

Investing Activities

Our net cash flows used in investing activities were $0.4 million and $2.1 million during the three months ended March 31, 2025 and 2024 respectively. The variance is primarily explained by capitalized costs for the headquarters move to Châtillon.

Financing Activities

Our net cash flows from financing activities were $45 thousand for the three months ended March 31, 2025 compared to $(62) thousand for the three months ended March 31, 2024.

Off-Balance Sheet Arrangements

We have not entered into any off-balance sheet arrangements and do not have variable interests in variable interest entities.

Smaller Reporting Company Status

We are a smaller reporting company as defined in the Securities Exchange Act of 1934, as amended. We may, and intend to, take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as we are a smaller reporting company. We may be a smaller reporting company in any year in which (i) the market value of our voting and non-voting ordinary shares held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter or (ii) (a) our annual revenue is less than $100.0 million during the most recently completed fiscal year and (b) the market value of our voting and non-voting ordinary shares held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.

Item 4. Controls and Procedures

Disclosure Controls and Procedures

Based on its evaluation as of March 31, 2025, our management, including our Chief Executive Officer and Chief Financial Officer, concluded that our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act) were effective to provide reasonable assurance that (i) the information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the

SEC Form 10-Q filed by DBV Technologies S.A.