DBV Technologies S.A 10-Q for FY2025 Q3
DBV Technologies S.A. (DBVT)
10-Q
2025-10-28
For: 2025-09-30
View Original
Added on
April 10, 2026
About this 10-Q
DBV Technologies S.A filed this 10-Q on October 28, 2025, covering the quarter ended September 30, 2025 (FY2025 Q3).
Headline figures
Quarter ended September 30, 2025, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $2.77M
- up 158.8% from $1.07M a year earlier
- Net loss
- $33.16M
- compared with a net loss of $30.44M a year earlier
- Diluted EPS
- -$0.24
- compared with -$0.32 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
____________________
FORM 10-Q
____________________
(Mark One)
For the quarterly period ended September 30, 2025
or
For the transition period from ______________ to _______________
Commission file number 001-36697
(Exact name of registrant as specified in its charter)
____________________
| Not applicable | |||||
| State or other jurisdiction of incorporation or organization | (I.R.S. Employer Identification No.) | ||||
| N/A | |||||
| (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 | ||||||||||||
*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 | ☐ | |||||||||||
| ☒ | 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 October 27, 2025, the registrant had 169,113,619 ordinary shares, nominal value €0.10 per share, outstanding including treasury shares.
Table of contents
| Part I | 2 | |||||||
| Item 1 | Condensed Consolidated Statements of Financial Position (Unaudited) as of September 30, 2025 and December 31, 2024 | 2 | ||||||
| 3 | ||||||||
Condensed Consolidated Statements of Cash Flows (Unaudited) for the Nine Months Ended September 30, 2025 and 2024 | 4 | |||||||
| 5 | ||||||||
6 | ||||||||
| Item 2 | 17 | |||||||
| Item 3 | 24 | |||||||
| Item 4 | 24 | |||||||
| Part II | 25 | |||||||
| Item 1 | 25 | |||||||
| Item 1A | 25 | |||||||
| Item 2 | 25 | |||||||
| Item 3 | 25 | |||||||
| Item 4 | 25 | |||||||
| Item 5 | 25 | |||||||
| Item 6 | 26 | |||||||
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®”, 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 the 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 the Viaskin Peanut patch;
•our expectations regarding initiation of the confirmatory effectiveness study for Viaskin Peanut patch in 1 - 3 years-old;
•plans and expectations with respect to the COMFORT Toddlers supplemental safety study of Viaskin Peanut patch in 1-3 years-old;
•anticipated support for the BLA re-submission for the 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 the Viaskin Peanut patch 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 the Viaskin Peanut patch 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 the Viaskin Peanut patch 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 the Viaskin Peanut patch 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 amended by Amendment No. 1 on Form 10-K/A filed with the SEC on April 28, 2025, and as amended further by Amendment No. 2 on Form 10-K/A filed with the SEC on May 14, 2025 (the “Annual Report”). 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.
1
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 | September 30, 2025 | December 31, 2024 | |||||||||||||||
| Assets | |||||||||||||||||
| Current assets : | |||||||||||||||||
| Cash and cash equivalents | 3 | $ | |||||||||||||||
| Other current assets | 4 | ||||||||||||||||
| Total current assets | |||||||||||||||||
| Property, plant, and equipment, net | |||||||||||||||||
| Right-of-use assets related to operating leases | 5 | ||||||||||||||||
| Intangible assets | |||||||||||||||||
| Other non-current assets | |||||||||||||||||
| Total non-current assets | |||||||||||||||||
| Total Assets | $ | ||||||||||||||||
| Liabilities and shareholders' equity | |||||||||||||||||
| Current liabilities: | |||||||||||||||||
| Trade payables | 6 | $ | |||||||||||||||
| Short-term operating leases | 5 | ||||||||||||||||
| Current contingencies | 9 | ||||||||||||||||
| Other current liabilities | 6 | ||||||||||||||||
| Total current liabilities | |||||||||||||||||
| Long-term operating leases | 5 | ||||||||||||||||
| Non-current contingencies | 9 | ||||||||||||||||
| Total non-current liabilities | |||||||||||||||||
| Total Liabilities | $ | ||||||||||||||||
| Shareholders’ equity : | |||||||||||||||||
Ordinary shares, € | $ | ||||||||||||||||
| Additional paid-in capital | |||||||||||||||||
Treasury stock, | ( | ( | |||||||||||||||
| Accumulated deficit | ( | ( | |||||||||||||||
| Accumulated other comprehensive income | |||||||||||||||||
| Accumulated currency translation effect | ( | ( | |||||||||||||||
| Total Shareholders’ equity | 7 | $ | |||||||||||||||
| Total Liabilities and Shareholder's equity | $ | ||||||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
2
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 September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||||||||
| Operating income | 10 | $ | |||||||||||||||||||||||||||
| Operating expenses | 11 | ||||||||||||||||||||||||||||
| Research and development expenses | ( | ( | ( | ( | |||||||||||||||||||||||||
| Sales and marketing expenses | ( | ( | ( | ( | |||||||||||||||||||||||||
| General and administrative expenses | ( | ( | ( | ( | |||||||||||||||||||||||||
| Total Operating expenses | ( | ( | ( | ( | |||||||||||||||||||||||||
| Loss from operations | ( | ( | ( | ( | |||||||||||||||||||||||||
| Financial income (expense) | ( | ||||||||||||||||||||||||||||
| Loss before taxes | ( | ( | ( | ( | |||||||||||||||||||||||||
| Income tax | ( | ( | |||||||||||||||||||||||||||
| Net loss | $ | ( | ( | ( | ( | ||||||||||||||||||||||||
| Foreign currency translation differences, net of taxes | ( | ( | |||||||||||||||||||||||||||
| Actuarial gains or losses on employee benefits, net of taxes | ( | ( | ( | ( | |||||||||||||||||||||||||
| Comprehensive loss | $ | ( | ( | ( | ( | ||||||||||||||||||||||||
| Basic/diluted Net loss per share attributable to shareholders | 14 | $ | ( | ( | ( | ( | |||||||||||||||||||||||
| Weighted average shares outstanding used in computing per share amounts: | |||||||||||||||||||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
DBV Technologies S.A.
Condensed Consolidated Statements of Cash Flows (unaudited)
(amounts in thousands)
| Notes | Nine Months Ended September 30, | ||||||||||||||||
| 2025 | 2024 | ||||||||||||||||
| Net loss for the period | $ | ( | ( | ||||||||||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||||||||
| Depreciation, amortization and accrued contingencies | ( | ||||||||||||||||
| Expenses related to share-based payments | 8 | ||||||||||||||||
| Inventory write-downs | |||||||||||||||||
| Other elements | |||||||||||||||||
| Changes in operating assets and liabilities: | |||||||||||||||||
| Decrease (increase) in inventories and work in progress | ( | ( | |||||||||||||||
| Decrease (increase) in other current assets | ( | ( | |||||||||||||||
| (Decrease) increase in trade payables | ( | ||||||||||||||||
| (Decrease) increase in other current and non-current liabilities | ( | ( | |||||||||||||||
| Change in operating lease liabilities and right of use assets | |||||||||||||||||
| Net cash flow used in operating activities | ( | ( | |||||||||||||||
| Cash flows used in investing activities : | |||||||||||||||||
| Change in property, plant, and equipment | ( | ( | |||||||||||||||
| Change in non-current financial assets | ( | ||||||||||||||||
| Net cash flows used in investing activities | ( | ( | |||||||||||||||
| Cash flows provided by financing activities : | |||||||||||||||||
| Treasury shares | ( | ||||||||||||||||
| Capital increases, net of transaction costs | |||||||||||||||||
| Net cash flows provided by financing activities | ( | ||||||||||||||||
| Effect of exchange rate changes on cash and cash equivalents | ( | ||||||||||||||||
| Net (decrease) / increase in cash and cash equivalents | 3 | ( | |||||||||||||||
| Net Cash and cash equivalents at the beginning of the period | |||||||||||||||||
| Net cash and cash equivalents at the end of the period | $ | ||||||||||||||||
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.
4
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 | ( | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net (loss) | — | — | — | — | ( | — | — | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other comprehensive income (loss) | — | — | — | — | — | ( | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of ordinary shares | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of share warrants | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treasury shares | — | — | — | ( | — | — | — | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Share-based payments | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Allocation of accumulated net losses | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance at March 31, 2024 | ( | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net (loss) | — | — | — | — | ( | — | — | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other comprehensive income (loss) | — | — | — | — | — | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of ordinary shares | ( | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of share warrants | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treasury shares | — | — | — | ( | — | — | — | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Share-based payments | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Allocation of accumulated net losses | ( | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance at June 30, 2024 | $ | $ | $ | ( | $ | ( | $ | $ | ( | $ | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net (loss) | — | — | — | — | ( | — | — | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other comprehensive income (loss) | — | — | — | — | — | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of ordinary shares | ( | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of share warrants | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treasury shares | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Share-based payments | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Allocation of accumulated net losses | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other change in equity | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance at September 30, 2024 | $ | $ | $ | ( | $ | ( | $ | $ | ( | $ | ||||||||||||||||||||||||||||||||||||||||||||||||||||
5
| 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 | ( | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net (loss) | — | — | — | — | ( | — | — | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other comprehensive income (loss) | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of ordinary shares | ( | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of share warrants | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treasury shares | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Share-based payments | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Allocation of accumulated net losses | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance at March 31, 2025 | ( | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net (loss) | — | — | — | — | ( | — | — | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other comprehensive income (loss) | — | — | — | — | — | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of ordinary shares | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of share warrants | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treasury shares | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Share-based payments | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Allocation of accumulated net losses | — | — | ( | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance at June 30, 2025 | $ | $ | $ | ( | $ | ( | $ | $ | ( | $ | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net (loss) | — | — | — | — | ( | — | — | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other comprehensive income (loss) | — | — | — | — | — | ( | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of ordinary shares | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of share warrants | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treasury shares | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Share-based payments | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other change in equity | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance at September 30, 2025 | $ | $ | $ | ( | $ | ( | $ | $ | ( | $ | ||||||||||||||||||||||||||||||||||||||||||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
6
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 method of delivering biologically active compounds to the immune system through intact skin using the Viaskin patch.
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, as amended by Amendment No. 1 on Form 10-K/A filed with the SEC on April 28, 2025, and as amended further by Amendment No. 2 on Form 10-K/A filed with the SEC on May 14, 2025. 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.
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.
As of September 30, 2025, the Company had cash and cash equivalents of $69.8 million. The Company does not generate revenue and continues to incur operating losses and negative cash flows from operations as it advances its product development programs and prepares for potential regulatory submissions and commercialization activities in anticipation to 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 the Viaskin Peanut patch’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 March 27, 2025, the Company announced the 2025 PIPE. On April 7, 2025, the Company received gross proceeds of $125.5 million (€116.3 million) from the issuance of securities including, ABSAs and PFW-BS-PFWs, as described in the Company’s Quarterly Report on Form 10-Q for the Quarter ended March 31, 2025 filed with the SEC on April 30, 2025.
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 American Depositary Shares (“ADS”), from time to time, through Citizens as its sales agent. 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 (subject to French regulatory limits) from time to time through Citizens. 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. 333-271166). 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. Subsequent to the end of the third quarter, the Company received a total gross amount of approximately $30 million from the sale of 11,538,460 Ordinary Shares (underlying 2,307,692 ADSs) on October 6, 2025 pursuant to the ATM Offering.
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The Company may also receive an aggregate of up to $181.4 million (€168.2 million) in gross proceeds if all 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 the warrants (results expected by the fourth quarter of 2025). DBV expects that the proceeds of this funding will be used for working capital and general corporate purposes, to finance the continued development of the Viaskin Peanut program in 4-7 years old, to finance the preparation and submission of a potential Biologics License Application (“BLA”) and, to finance the readiness of a launch of Viaskin peanut in the US after, if approved.
As of the date of the filing, with the receipt of the aforementioned proceeds, and based on its current operations, plans, and assumptions examined by the Board on October 28, 2025, the Company estimates that its cash and cash equivalents are sufficient to fund its operations into the third quarter of 2026.
As such, cash and cash equivalents are not sufficient to fund operations for the next 12 months, and these conditions and events raise substantial doubt about the Company's ability to continue as a going concern
Management is also actively pursuing financing options including additional sales under the ATM program, potential warrant exercises, and strategic transactions.
These Condensed Consolidated Financial Statements do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses that may be necessary if the Company were unable to continue as a going concern.
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
In November 2023, the FASB issued ASU 2023-07, Improvements to Reportable Segment Disclosures (Topic 280), which requires incremental disclosures on reportable segments, primarily through enhanced disclosures on significant segment expenses. The Company adopted this guidance beginning in the fourth quarter of fiscal year 2024 for our annual report (10-K) and for interim periods starting in fiscal year 2025.
The company has not identified any recent 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 will adopt this guidance beginning in the fourth quarter of fiscal year 2025 for our annual report. The Company is currently evaluating the impact the adoption of this ASU 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, the Company announced the submission of a BLA to the FDA for the Viaskin Peanut patch 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 patch BLA in its then-current form. The FDA did not raise any safety concerns related to the Viaskin Peanut patch.
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
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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 the Company’s EPITOPE phase 3 study assessing the safety and efficacy of the Viaskin Peanut patch for the treatment of peanut-allergic toddlers 1 - 3 years old (“EPITOPE”).
On April 19, 2023, the Company outlined the regulatory pathway for the Viaskin Peanut patch 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 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 the Viaskin Peanut patch 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 met Accelerated Approval qualifying criterion 1 and 2. Regarding criterion 3, FDA 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 the Viaskin Peanut patch is approved.
The Company announced further that it aligned with FDA on a wear time collection methodology in COMFORT Toddlers intended to generate sufficient data to support a BLA submission. On June 25, 2025, the Company announced that the first subject was screened in the COMFORT Toddlers supplemental safety study in peanut allergic toddlers 1-3 years old. 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 the 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, which was initiated in June 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 the 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 is no longer required and the Company will not conduct the study. The Company will utilize safety data from VITESSE participants randomized to active treatment as well as placebo-crossover participants in the VITESSE Open Label Extension (OLE) study. Accordingly, the Company plans to submit a BLA for the Viaskin Peanut patch in 4-7 year-olds 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, the Company announced that our Marketing Authorization Application, or MAA, for the Viaskin Peanut patch, 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.
On August 2, 2021, the Company announced it had received from the EMA the Day 180 list of outstanding issues, which is an established part of the prescribed EMA review process, which identified one Major Objection remained at Day 180 questioning the limitations of the data, for example, the clinical relevance and effect size supported by a single pivotal study.
On December 17, 2021, the Company announced it had withdrawn the MAA for the Viaskin Peanut patch and formally notified the EMA of our decision.
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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 also 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 the Viaskin Peanut patch 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. The COMFORT Toddlers supplemental safety study, which was initiated in June 2025, will augment the safety data collected from EPITOPE in support of a BLA, will 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 the Viaskin Peanut patch 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 the Viaskin Peanut patch across all efficacy parameters. These data were presented at the annual American College of Allergy, Asthma and Immunology (ACAAI) in November 2023.
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 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 the Viaskin Peanut patch 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. On June 25, 2025, the Company announced that the first subject was screened in COMFORT Toddlers supplemental safety study in peanut allergic toddlers 1 – 3 years old. 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, which was initiated in June 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.
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.
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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 is no longer required and the Company will not conduct the study. The Company will utilize safety data from VITESSE participants randomized to active treatment as well as placebo-crossover participants in the VITESSE Open Label Extension (OLE) study. Accordingly, the Company plans to submit a BLA for the Viaskin Peanut patch in 4-7 year-olds 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 at $1.0739 :1€ as per European Central Bank on March 27, 2025), 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 the Viaskin Peanut patch 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 consisted 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 $42 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"); 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 $86 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").
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 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. Pursuant to the registration rights agreement with each investor participating in the Offering, the Company filed a registration statement with the SEC registering the resale of the ordinary shares, including the ordinary shares underlying the warrants, issued as part of the Offering.
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 American Depositary Shares (“ADS”), from time to time, through Citizens as its sales agent. 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 (subject to French regulatory limits) from time to time through Citizens. 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. 333-271166). 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. Subsequent to the end of the third quarter, the Company also received a total gross amount of approximately $30 million from the sale of 11,538,460 Ordinary Shares (underlying 2,307,692 ADSs) received on October 6, 2025 pursuant to the ATM Offering.
As of date of filing, taking into account cash and cash equivalents as well as the aforementioned proceeds, and based on its current operations, plans and assumptions, the Company estimates that it has a sufficient balance of cash and cash equivalents to fund its operations into the third quarter of 2026.
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
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ASC 480 – DISTINGUISHING LIABILITIES FROM EQUITY
Under ASC480–10–25, a financial instrument should be classified as liability if :
(i) It is mandatorily redeemable,
(ii) It represents an unconditional obligation to repurchase the issuer’s equity shares,
(i) It requires the issuer to deliver a variable number of share or net cash settlement.
In our view, April 2025 prefunded warrants avoid all ASC 480 triggers as they meet the following conditions :
(i) Freestanding and detachable : they are legally separable from other instruments,
(ii) Fixed exercise terms : they entitle the holder to a fixed number of shares upon exercise,
(iii) No redemption obligations : they do not require the issuer to transfer cash to repurchase shares.
ASC 815 – DERIVATIVES AND HEDGING
ASC 815 – 40 – Contracts in Entity’s Own Equity addresses whether an equity-linked contract, qualifies as equity in the entity’s financial statements.
Indexation to the Company’s own stock
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.
To determine whether an equity-linked instrument is indexed to the Entity’s own stock, a 2-step analysis must be performed:
Step 1 – Evaluate whether the instrument contains any exercise contingencies, and, if so, whether they disqualify the instrument from being classified as equity,
Step 2 – Assess whether the settlement terms are consistent with equity classification.
Based on the above elements Prefunded warrants are to be indexed to the Company‘s stock.
Equity classification
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.
Other conditions necessary for equity classification are met:
1.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 warrants could remain outstanding.
2.The contract contains an explicit limit on the number of shares (1 share per First Prefunded 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. Adjustments to the exercise ratio are subject to the occurrence of specific events and result from the application of determined formulas.
3.There is no required cash payment if DBV S.A. fails to timely file. There is no requirement to net cash settle the contract in the event the entity fails to make timely filings with the Securities and Exchange Commission (SEC).
4.There are no cash settled top-off or make-whole provisions.
April 2025 Prefunded warrants can be classified as equity and shall be accounted for in permanent equity. Subsequent changes in fair value shall not be recognized as long as they continue to be classified as equity.
Legal Proceedings
Note 3: Cash and Cash Equivalents
The following tables summarize the cash and cash equivalents as of September 30, 2025 and December 31, 2024:
| September 30, 2025 | December 31, 2024 | ||||||||||
| Cash | |||||||||||
| Cash equivalents | |||||||||||
| Total cash and cash equivalents as reported in the statements of financial position | |||||||||||
Cash equivalents are convertible into cash on 32 days notice at no or insignificant cost, on demand. They are measured using level 1 fair value measurements.
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Note 4: Other Current Assets
Other current assets consisted of the following:
| September 30, 2025 | December 31, 2024 | ||||||||||
| Research tax credit | |||||||||||
| VAT assets | |||||||||||
| Prepaid expenses | |||||||||||
| Other receivables | |||||||||||
| Total | |||||||||||
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 | |||||
| Operating income | |||||
| - Payment received | ( | ||||
| - Adjustment and currency translation effect | |||||
| Closing research tax credit receivable as of September 30, 2025 | |||||
| Of which - Non-current portion | |||||
| Of which - Current portion | |||||
The estimated research tax credit for the first nine months ended September 30, 2025 amounts to $5.0 million.
The VAT assets 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 September 30, 2025 and December 31, 2024, are as follows:
| September 30, 2025 | December 31, 2024 | ||||||||||||||||||||||||||||||||||
| Real Estate | Other assets | Total | Real Estate | Other assets | Total | ||||||||||||||||||||||||||||||
| Current portion | |||||||||||||||||||||||||||||||||||
| Year 2 | |||||||||||||||||||||||||||||||||||
| Year 3 | |||||||||||||||||||||||||||||||||||
| Thereafter | |||||||||||||||||||||||||||||||||||
| Total minimum lease payments | |||||||||||||||||||||||||||||||||||
| Less: Effects of discounting | ( | ( | ( | ( | ( | ( | |||||||||||||||||||||||||||||
| Present value of lease liabilities | |||||||||||||||||||||||||||||||||||
| Less: current portion | ( | ( | ( | ( | ( | ( | |||||||||||||||||||||||||||||
| Long-term lease liabilities | |||||||||||||||||||||||||||||||||||
| Weighted average remaining lease term (years) | |||||||||||||||||||||||||||||||||||
| Weighted average discount rate | % | % | % | % | |||||||||||||||||||||||||||||||
13
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:
| September 30, | |||||||||||
| 2025 | 2024 | ||||||||||
| Operating lease expense / (income) | |||||||||||
| Net termination impact | ( | ( | |||||||||
Supplemental cash flow information related to operating leases is as follows for the period September 30, 2025 and 2024:
| September 30, | |||||||||||
| 2025 | 2024 | ||||||||||
| Cash paid for amounts included in the measurement of lease liabilities | |||||||||||
| Operating cash flows used in operating leases | |||||||||||
Note 6: Trade Payables and Other Liabilities
6.1 Trade Payables
Trade payables increased by $17.8 million as of September 30, 2025, compared to December 31, 2024, reflecting the increase in manufacturing spending.
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 September 30, 2025 and December 31, 2024:
| September 30, 2025 | December 31, 2024 | ||||||||||||||||||||||||||||||||||
| Other current liabilities | Other non-current liabilities | Total | Other current liabilities | Other non-current liabilities | Total | ||||||||||||||||||||||||||||||
| Employee related liabilities | |||||||||||||||||||||||||||||||||||
| Tax liabilities | |||||||||||||||||||||||||||||||||||
| Other debts | |||||||||||||||||||||||||||||||||||
| Total | |||||||||||||||||||||||||||||||||||
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 September 30, 2025 is set at the sum of €13,697,516 ($15,394 thousands converted to USD at historical rates). It is divided into 136,975,159 fully authorized, subscribed and paid-up ordinary shares with a par value of €0.10 .
Pursuant to the authorizations granted by the Combined General Meeting of Shareholders of June 11, 2025, DBV Technologies S.A.'s net income for the year ended December 31, 2024 was allocated to retained earnings, leaving a debit balance of €102,284,799.30 .
Pursuant to the delegations of authority granted by the Combined General Meeting of Shareholders of May 16, 2024 (“the 2024 Meeting”) under the terms of the 24th and 30th resolutions of the 2024 Meeting, the Board of Directors of the Company (“the Board”), at its meeting of March 27, 2025, for a maximum nominal amount of €28,929,000 :
•noted that the offering would consist of a capital increase with cancellation of preferential subscription rights, reserved exclusively for the beneficiaries defined in the 24th resolution of the 2024 Meeting, by way of an issue of:
–ordinary shares (the “New Shares”) each with warrants attached (the “ABSA Warrants”, and together with the New Shares, the “ABSA”) to subscribe to 1.75 ordinary shares (the “ABSA Warrant Shares”); and
–units (the “PFW-BS-PFW”) consisting of (i) one pre-funded warrant (each a “First Pre-Funded Warrant”) giving the right, in the event of exercise, to 1 ordinary share of the Company (each a “First PFW Share”) and (ii) 1 warrant (each a “BS Warrant”) to purchase 1 pre-funded warrant (each a “Second Pre-Funded Warrant”) giving the right, in the event of exercise, to 1.75 ordinary shares of the Company (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”).
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•decided on the principle of:
–a capital increase in cash with cancellation of the shareholders' preferential subscription right by way of an offer reserved to certain categories of investors by the issuance of ABSA;
–issuing PFW-BS-PFW with cancellation of the shareholders' preferential subscription right by way of an offer reserved to certain categories of investors;
–one or more capital increase(s) in cash with cancellation of the shareholders' preferential subscription right for the benefit of the holders of ABSA Warrants, First Pre-Funded Warrants, BS Warrants and Second Pre-Funded Warrants.
•granted a number of authorizations for the purpose of carrying out the capital increase(s);
•sub-delegated its authority to the Chief Executive Officer for the purpose of implementing the financing and record the final completion of the capital increase in respect of the New Shares and of all capital increases in respect of the Warrant Shares.
On March 27, 2025, acting under the sub-delegation granted to it by the Board in its decisions of March 27, 2025, and after having noted that the volume average price of the Company’s shares on Euronext Paris, calculated over 5 consecutive trading sessions out of the last 30 trading sessions preceding the setting of the price (i.e. the sessions of March 13, 14, 17, 18 and 19, 2025 is 0.8989 euro (the “Reference Share Price”) and the Reference Share Price less a 15 % discount is equal to 0.7641 euro, the Chief Executive Officer :
•decided consequently to set the price of each ABSA at 1.1136 euros, corresponding to a premium of 23.89 % compared to the Reference Share Price (the “ABSA Price”);
•decided that the issue price of each PFW-BS-PFW is equal to the ABSA Price and corresponds to the price of the First Pre-Funded Warrants to be paid up on the date of issue of the PFW-BS-PFW and to the balance of the exercise price of the First Pre-Funded Warrants equal to 0.01 euro per First Pre-Funded Warrant;
•decided, making use of the 24th resolution of the 2024 General Meeting, in accordance with Article L.225-138 of the French Commercial Code, to
(i) increase the share capital of the Company in cash through the issuance, sale and delivery of 34,090,004 ABSA to be subscribed for at a subscription price of 1.1136 euros per ABSA (i.e. 0.10 par value and 1.0136 euros of issue premium), with cancellation of the shareholders' preferential subscription right within the framework of the Offering, to be fully paid up at the time of subscription, i.e. a capital increase of a nominal amount of 3,409,000.40 euros, and
(ii) issue, sale and deliver 71,005,656 PFW-BS-PFW at an aggregate price of 1.1136 euros per PFW-BS-PFW with cancellation of the shareholders' preferential subscription right within the framework of the Offering, to be fully paid up at the time of subscription;
On April 7, 2025, the Chief Executive Officer noted: (i) that the 34,090,004 new ordinary shares with a nominal amount of €0.10 have been fully subscribed and fully paid up, (ii) the final completion of the capital increase, and (iii) the share capital of the Company has consequently been increased from €10,285,886.80 , divided into 102,858,868 shares, to €13,694,887.20 , divided into 136,948,872 shares with a nominal 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 nine months ended September 30, 2025, the Company granted 215,000 stock options and 35,000 restricted stock units.
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 | |||||||||||||||||
| Granted during the period | |||||||||||||||||
| Forfeited during the period | ( | ( | |||||||||||||||
| Released during the period | ( | ||||||||||||||||
| Expired during the period | ( | ( | |||||||||||||||
| Balance as of September 30,2025 | |||||||||||||||||
Share-based payments expense reflected in the condensed consolidated statements of operations is as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||||||||
| Research & development | SO | ( | ( | ( | ( | ||||||||||||||||||||||||
| RSU | ( | ( | ( | ( | |||||||||||||||||||||||||
| Sales & marketing | SO | ( | ( | ( | ( | ||||||||||||||||||||||||
| RSU | ( | ( | ( | ( | |||||||||||||||||||||||||
| General & administrative | SO | ( | ( | ( | ( | ||||||||||||||||||||||||
| RSU | ( | ( | |||||||||||||||||||||||||||
| Total share-based compensation (expense) | ( | ( | ( | ( | |||||||||||||||||||||||||
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Note 9: Contingencies
The following tables summarize the contingencies as of September 30, 2025 and December 31, 2024:
| September 30, 2025 | December 31, 2024 | ||||||||||
| Current contingencies | |||||||||||
| Non-current contingencies | |||||||||||
| Total contingencies | |||||||||||
The changes in contingencies are as follows:
| Pension retirement obligations | Other contingencies | Total | |||||||||||||||||||||
| At January 1, 2025 | |||||||||||||||||||||||
| Increases in liabilities | |||||||||||||||||||||||
| Used liabilities | — | ( | ( | ||||||||||||||||||||
| Actuarial gains and losses on defined-benefit plans | — | ||||||||||||||||||||||
| Currency translation effect | |||||||||||||||||||||||
At September 30, 2025 | |||||||||||||||||||||||
| Of which current | |||||||||||||||||||||||
| Of which non-current | |||||||||||||||||||||||
Note 10: Operating income
The following table summarizes the operating income during the three and the nine months ended September 30, 2025 and 2024:
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
| Research tax credit | |||||||||||||||||||||||
| Total | |||||||||||||||||||||||
Note 11: Operating Expenses
The Company had an average of 117 employees at September 30, 2025, in comparison with an average of 108 employees at September 30, 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 nine months ended September 30, 2025 and 2024:
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
| Research and Development expenses | |||||||||||||||||||||||
| Sales & Marketing expenses | |||||||||||||||||||||||
| General & Administrative expenses | |||||||||||||||||||||||
| Total personnel expenses | |||||||||||||||||||||||
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The following table summarizes the allocation of personnel expenses by nature during the nine months ended September 30, 2025 and 2024:
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
| Wages and salaries | |||||||||||||||||||||||
| Social security contributions | |||||||||||||||||||||||
| Expenses for pension commitments | ( | ||||||||||||||||||||||
| Share-based payments | |||||||||||||||||||||||
| Total | |||||||||||||||||||||||
Note 12: Commitments
On August 29, 2025, the Company updated its Manufacturing and Supply Agreement (the “Supply Agreement”) with SANOFI WINTHROP INDUSTRIE (“SANOFI”), under which SANOFI will manufacture and supply the Viaskin® Peanut API exclusively for the Company during the term of the Supply Agreement. Under such, the Company has agreed to certain minimum purchase levels and service fees over the initial 4-year -term.
As of September 30, 2025, total payments made during the period under the Supply Agreement are approximately $5,875 million, which were recorded as R&D expenses.
We have non-cancellable minimum commitments for products and services, subject to the Supply Agreement. Under US GAAP, take-or-pay arrangements are generally considered firm purchase commitments. As of September 30, 2025, we have assessed our ability to meet our performance obligations as per US GAAP requirements (ASC 440-10: Commitments, ASC 450-20: Loss Contingencies and ASC 330-10-35: Inventory and purchase commitments) and confirm to commit to agreed volumes. Hence, we have not recognized on the balance sheet any loss provision.
Future purchase commitments as of September 30, 2025, are as follows and are consistent with the Company’s overall manufacturing and supply strategy in preparation for potential commercial launch activities.
in thousands USD | 2025 | 2026 | 2027 | 2028 | Total | |||||||||||||||
Commitments | ||||||||||||||||||||
Note 13: Relationships with Related Parties
There were no changes in the nature of the transactions from those described in Note 13 to the consolidated financial statements included in the Annual Report.
As part of the financing announced in a press release on March 27, 2025, the Company's Board of Directors on March 27, 2025 authorized 3 new transactions with related parties, in accordance with article L 225-38 of the French Commercial Code:
–The signature of a Securities Purchase Agreement between the Company and Baker Brothers Advisors LP, a shareholder of the Company owning a fraction of the voting rights above 10% ;
–The signature of a Securities Purchase Agreement between the Company and BPIfrance Participations SA, a shareholder with a permanent representative at the Company's Board of Directors;
–The signature of a Registration Rights Agreement between the Company and its investors, in particular Baker Brothers Advisors LP and BPIfrance Participations SA.
Management changes
During the quarter ended September 30, 2025, Caroline Daniere, who served as Chief Human Resources Officer “CHRO” and member of the Executive Committee, departed the Company effective July 23, 2025. James Briggs was appointed as CHRO and became a member of the Executive Committee as of June 24,2025.
During the quarter ended September 30, 2025, Caroline Daniere, who served as Chief Human Resources Officer “CHRO” and member of the Executive Committee, departed the Company effective July 23, 2025. James Briggs was appointed as CHRO and became a member of the Executive Committee as of June 24,2025.
The Company did not enter into any related-party transactions with either individual under ASC 850 Related Party Disclosures other than compensation arrangements in the ordinary course of business.
Board of Directors changes
During the same period, Daniel Soland, an independent member of the Board of Directors, resigned effective September 18, 2025.
There were no related-party transactions involving M. Soland and the board of directors during the period covered by this report.
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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 nine months ended September 30, 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 as of September 30, 2025 and 2024 indicated in number of potential shares:
As of September 30, | |||||||||||||||||||||||
| 2025 | 2024 | ||||||||||||||||||||||
| Non-employee warrants | |||||||||||||||||||||||
| Stock options | |||||||||||||||||||||||
| Restricted stock units | |||||||||||||||||||||||
| Prefunded warrants | |||||||||||||||||||||||
Note 15: Events after the Close of the Period
On October 6, 2025, the Company announced that pursuant to the Company’s ATM Offering it had issued and completed the sale of new Ordinary Shares in the form of ADS, for a total gross amount of approximately $30 million. In this context 11,538,460 new Ordinary Shares (underlying 2,307,692 new ADSs) were issued through a capital increase without preferential subscription rights of the shareholders reserved to specific categories of persons fulfilling certain characteristics, at an at-the-market price of $13.00 per ADS (i.e., a subscription price per Ordinary Share of €2.2264 based on the USD/EUR exchange rate of $1.1678 for €1, as published by the European Central Bank on October 6, 2025) and each ADS giving the right to receive 5 Ordinary Shares of the Company.
Note 16: Reportable segment disclosure
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
| Clinical studies | |||||||||||||||||||||||
| BLA & Regulatory | |||||||||||||||||||||||
| Medical Affairs & Other Medical | |||||||||||||||||||||||
| Research & Innovation | |||||||||||||||||||||||
| Manufacturing & Supply and Quality | |||||||||||||||||||||||
| Sales & Marketing | |||||||||||||||||||||||
| General & Administrative | |||||||||||||||||||||||
| Total expenses | |||||||||||||||||||||||
The Company operates and is managed as one operating segment driving expenses for the development of the Viaskin Peanut patch. The Company’s R&D organization is primarily responsible for the development and registration efforts of the Viaskin Peanut patch. 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.
18
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, as amended by Amendment No. 1 on Form 10-K/A filed with the SEC on April 28, 2025, and as amended further by Amendment No. 2 on Form 10-K/A filed with the SEC on May 14, 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 the Viaskin Peanut patch, 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, and an ongoing 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. After 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 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 met Accelerated Approval qualifying criterion 1 and 2 . Regarding criterion 3, FDA 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 the Viaskin Peanut patch is approved.
The Company announced further that it 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. On June 25, 2025, the Company announced that the first subject was screened in COMFORT Toddlers supplemental safety study in peanut allergic toddlers 1 – 3 years old. 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
19
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, which was initiated in June 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.
On June 25, 2025, the Company announced that the first subject was screened in COMFORT Toddlers supplemental safety study in peanut allergic toddlers 1 – 3 years old.
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.
Manufacturing and Supply Agreement
On August 29, 2025, the Company updated the Supply Agreement with SANOFI, under which SANOFI will manufacture and supply the Viaskin Peanut API exclusively for the Company during the term of the Supply Agreement. The Supply Agreement has an initial term of four years with a possibility to extend for an additional period. The effective date of the Supply Agreement is January 1, 2025.
The Supply Agreement includes terms related to manufacturing, quality control, pricing, volume commitments, and supply obligations. The Supply Agreement is designed to secure commercial-scale manufacturing capacity in preparation for a potential Biologics License Application (“BLA”) submission and subsequently, the commercial launch of the Viaskin Peanut patch in the United States, if approved.
We have non-cancellable minimum commitments for products and services, subject to the Supply Agreement. Under US GAAP, take-or-pay arrangements are generally considered firm purchase commitments. As of September 30, 2025, we have assessed our ability to meet our performance obligations as per US GAAP requirements (ASC 440-10: Commitments, ASC 450-20: Loss Contingencies and ASC 330-10-35: Inventory and purchase commitments) and confirm to commit to agreed volumes. Hence, we have not recognized on the balance sheet any loss provision.
The Company expects to incur expenditures related to support for BLA and PAI preparation, Cold storage rental, over the Supply Agreement term. These expenditures are consistent with the Company’s planned investments to strengthen its supply chain readiness ahead of potential regulatory milestones. The Company believes the Supply Agreement enhances the robustness of its manufacturing network and supports long-term product supply reliability.
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Business Trends and Results of Operations
Comparison of the Three Months Ended September 30, 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 September 30, 2025 and 2024.
| Three Months Ended September 30, | |||||||||||||||||||||||
| 2025 | 2024 | $ change | % of change | ||||||||||||||||||||
| Operating income | 2,774 | 1,072 | 1,702 | 159 | % | ||||||||||||||||||
| Operating expenses | |||||||||||||||||||||||
| Research and development expenses | (28,615) | (23,662) | (4,953) | 21 | % | ||||||||||||||||||
| Sales and marketing expenses | (1,178) | (519) | (659) | 127 | % | ||||||||||||||||||
| General and administrative expenses | (7,259) | (7,220) | (38) | 1 | % | ||||||||||||||||||
| Total Operating expenses | (37,051) | (31,401) | (5,650) | 18.0 | % | ||||||||||||||||||
| Financial income (expense) | 1,113 | (113) | 1,226 | (1084) | % | ||||||||||||||||||
| Income tax | — | — | — | — | |||||||||||||||||||
| Net loss | (33,164) | (30,442) | (2,723) | 9 | % | ||||||||||||||||||
Operating Income
The following table summarizes our operating income during the three months ended September 30, 2025 and 2024:
| Three Months Ended September 30, | |||||||||||||||||||||||
| 2025 | 2024 | $ change | % of change | ||||||||||||||||||||
| Other income | 2,774 | 1,072 | 1,702 | 159 | % | ||||||||||||||||||
| Research tax credit | 2,774 | 1,072 | 1,702 | 159 | % | ||||||||||||||||||
| Total operating income | 2,774 | 1,072 | 1,702 | 159 | % | ||||||||||||||||||
Research tax credit increased by $1.7 million for the three months ended September 30, 2025, compared to the three months ended September 30, 2024 primarily due to a greater proportion of activities eligible to receive the Research tax credit carried out in the third quarter 2025 than in the third quarter 2024.
Operating Expenses
Research and Development Expenses
The following table summarizes our research and development expenses incurred during the three months ended September 30, 2025 and 2024:
| Research and Development expenses | Three Months Ended September 30, | ||||||||||||||||||||||
| 2025 | 2024 | $ change | % of change | ||||||||||||||||||||
| External clinical-related expenses | 21,727 | 17,216 | 4,511 | 26 | % | ||||||||||||||||||
| Employee-related costs | 4,795 | 4,300 | 495 | 12 | % | ||||||||||||||||||
| Share-based payment expenses | 415 | 726 | (311) | (43) | % | ||||||||||||||||||
| Depreciation, amortization and other costs | 1,677 | 1,419 | 258 | 18 | % | ||||||||||||||||||
| Total Research and Development expenses | 28,615 | 23,662 | 4,953 | 21 | % | ||||||||||||||||||
Research and Development expenses increased by $5.0 million for the three months ended September 30, 2025 compared to the three months ended September 30, 2024.
External clinical-related expenses increased by $4.5 million mainly due to (1) the launch of the COMFORT Toddlers study following alignment with the FDA, and (2) regulatory and production activities to support ongoing clinical trials, BLA submission and pre-commercialization activities for Viaskin Peanut in North America.
Employee-related costs increased by $0.5 million for the three months ended September 30, 2025 compared to the three months ended September 30, 2024. This increase is mainly due to (1) recruitments made during the third quarter of 2024, mainly based in the United States, for which a full quarter of personnel costs are recognized at end-September 2025, and (2) additional recruitments made during the third quarter 2025.
Depreciation, amortization and other costs remain consistent for the three months ended September 30, 2025 compared to the three months ended September 30, 2024.
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Sales and Marketing Expenses
The following table summarizes our sales and marketing expenses incurred during the three months ended September 30, 2025 and 2024:
| Sales & Marketing expenses | Three Months Ended September 30, | ||||||||||||||||||||||
| 2025 | 2024 | $ change | % of change | ||||||||||||||||||||
| External professional services | 497 | 187 | 310 | 166 | % | ||||||||||||||||||
| Employee-related costs | 214 | 114 | 100 | 87 | % | ||||||||||||||||||
| Share-based payment expenses | 17 | 30 | (12) | (41) | % | ||||||||||||||||||
| Depreciation, amortization and other costs | 449 | 188 | 261 | 139 | % | ||||||||||||||||||
| Total Sales & Marketing expenses | 1,178 | 519 | 659 | 127 | % | ||||||||||||||||||
Sales and marketing expenses have increased by $0.7 million during the three months ended September 30, 2025, compared to the three months ended September 30, 2024 mainly due to higher Sales and Marketing activities to prepare support pre-commercialization activities for Viaskin Peanut in North America.
General and Administrative Expenses
The following table summarizes our general and administrative expenses incurred during the three months ended September 30, 2025 and 2024:
| General & Administrative expenses | Three Months Ended September 30, | ||||||||||||||||||||||
| 2025 | 2024 | $ change | % of change | ||||||||||||||||||||
| External professional services | 2,765 | 2,579 | 186 | 7 | % | ||||||||||||||||||
| Employee-related costs | 2,236 | 2,307 | (71) | (3) | % | ||||||||||||||||||
| Share-based payment expenses | 83 | 835 | (752) | (90) | % | ||||||||||||||||||
| Depreciation, amortization and other costs | 2,175 | 1,499 | 676 | 45 | % | ||||||||||||||||||
| Total General & Administrative expenses | 7,259 | 7,220 | 39 | 1 | % | ||||||||||||||||||
General and Administrative expenses remain consistent for the three months ended September 30, 2025, compared to the three months ended September 30, 2024.
External professional services increased by $0.2 million for the three months ended September 30, 2025, compared to the three months ended September 30, 2024 mainly due to financing activities.
Employee-related costs, excluding share-based payments, decreased by $0.1 million for the three months ended September 30, 2025, compared to the three months ended September 30, 2024 due to lower full time equivalent on third quarter 2025 compared to 2024.
The Share-based payment expenses decreased by $0.8 million mainly due to employees that lost their rights subsequently to their exits.
Depreciation, amortization and other costs increased by $0.7 million for the three months ended September 30, 2025, compared to the three months ended September 30, 2024 mainly due to depreciation related to the refurbishment of the Châtillon office and licenses increase following recruitment made in 2025.
Financial Income (Expense)
Our financial income was $1.1 million for the three months ended September 30, 2025, compared to a financial expense of $0.1 million for the three months ended September 30, 2024. This item mainly includes the gains from our investments.
Income Tax
Our income tax was nil for the three months ended September 30, 2025 and September 30, 2025.
Net Loss
Net loss was $33.2 million for the three months ended September 30, 2025, compared to $30.4 million for the three months ended September 30, 2024. Net loss per share (based on the weighted average number of shares outstanding over the period) was $ (0.24) and $ (0.32) for the three months ended September 30, 2025 and 2024, respectively.
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Comparison of the Nine Months Ended September 30, 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 nine months ended September 30, 2025 and 2024.
| Nine Months Ended September 30, | |||||||||||||||||||||||
| 2025 | 2024 | $ change | % of change | ||||||||||||||||||||
| Operating income | 4,991 | 3,640 | 1,351 | 37 | % | ||||||||||||||||||
| Operating expenses | |||||||||||||||||||||||
| Research and development expenses | (83,790) | (70,438) | (13,352) | 19 | % | ||||||||||||||||||
| Sales and marketing expenses | (1,858) | (2,263) | 404 | (18) | % | ||||||||||||||||||
| General and administrative expenses | (21,348) | (23,667) | 2,320 | (10) | % | ||||||||||||||||||
| Total Operating expenses | (106,997) | (96,368) | (10,628) | 11 | % | ||||||||||||||||||
| Financial income (expense) | 4 | 1,873 | (1,869) | (100) | % | ||||||||||||||||||
| Income tax | (117) | (48) | (69) | 143 | % | ||||||||||||||||||
| Net loss | (102,118) | (90,903) | (11,215) | 12 | % | ||||||||||||||||||
Operating Income
The following table summarizes our operating income during the nine months ended September 30, 2025 and 2024:
| Nine Months Ended September 30, | |||||||||||||||||||||||
| 2025 | 2024 | $ change | % of change | ||||||||||||||||||||
| Other income | 4,991 | 3,640 | 1,351 | 37 | % | ||||||||||||||||||
| Research tax credit | 4,991 | 3,640 | 1,351 | 37 | % | ||||||||||||||||||
| Total operating income | 4,991 | 3,640 | 1,351 | 37 | % | ||||||||||||||||||
During the nine months ended September 30, 2025 we generated an Operating Income of $5.0.million compared to $3.6.million during the nine months ended September 30, 2025.
Research tax credit increased by $1.4 million for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024 primarily due to the fact that more eligible activities have been carried out in the period, including the related costs of the FAREVA platform.
Operating Expenses
Research and Development Expenses
The following table summarizes our R&D expenses incurred during the nine months ended September 30, 2025 and 2024:
| Research and Development expenses | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2025 | 2024 | $ change | % of change | ||||||||||||||||||||
| External clinical-related expenses | 61,192 | 49,708 | 11,484 | 23 | % | ||||||||||||||||||
| Employee-related costs | 13,998 | 13,059 | 939 | 7 | % | ||||||||||||||||||
| Share-based payment expenses | 1,539 | 2,192 | (652) | -30 | % | ||||||||||||||||||
| Depreciation, amortization and other costs | 7,060 | 5,479 | 1,581 | 29 | % | ||||||||||||||||||
| Total Research and Development expenses | 83,790 | 70,438 | 13,352 | 19.0 | % | ||||||||||||||||||
Research and Development expenses increased by $13.4 million for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024.
External clinical-related expenses increased by $11.5 million mainly due to (1) the launch of the COMFORT Toddlers study following alignment with the FDA and (2) regulatory and production activities to support ongoing clinical trials, BLA submission and pre-commercialization activities for Viaskin Peanut in North America.
Employee-related costs increased by $0.9 million for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. This increase is primarily due to the recruitment carried out during the second quarter of 2024, mainly based in the United States in Medical, Quality and Regulatory Affairs, resulting in a full nine-month impact in 2025 compared to a four to six month impact in 2024.
Depreciation, amortization and other costs increased by $1.6 million for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. This increase is mainly due to a $1.1 million provision reversal at June 30, 2024, following the termination of the Collaboration Agreement with NESTEC, which reduced last year's charge.
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Sales and Marketing expenses
The following table summarizes our sales and marketing expenses incurred during the nine months ended September 30, 2025 and 2024:
| Sales & Marketing expenses | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2025 | 2024 | $ change | % of change | ||||||||||||||||||||
| External professional services | 755 | 754 | 1 | 0.1 | % | ||||||||||||||||||
| Employee-related costs | 527 | 640 | (114) | -17.8 | % | ||||||||||||||||||
| Share-based payment expenses | 55 | 91 | (36) | -39.8 | % | ||||||||||||||||||
| Depreciation, amortization and other costs | 522 | 777 | (255) | -32.9 | % | ||||||||||||||||||
| Total Sales & Marketing expenses | 1,858 | 2,263 | (404) | -17.9 | % | ||||||||||||||||||
Sales and Marketing expenses decreased by $0.4 million for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024, mainly due to (1) lower Sales and Marketing activities, (2) lower sales full time equivalent (following a transfer of assignment between sales and overheads) and (3) lower travel expenses.
General and Administrative expenses
The following table summarizes our general and administrative expenses incurred during the nine months ended September 30, 2025 and 2024:
| General & Administrative expenses | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2025 | 2024 | $ change | % of change | ||||||||||||||||||||
| External professional services | 6,370 | 8,173 | (1,804) | -22.1 | % | ||||||||||||||||||
| Employee-related costs | 7,354 | 7,001 | 354 | 5.1 | % | ||||||||||||||||||
| Share-based payment expenses | 1,869 | 2,791 | (922) | -33.0 | % | ||||||||||||||||||
| Depreciation, amortization and other costs | 5,755 | 5,703 | 52 | 0.9 | % | ||||||||||||||||||
| Total General & Administrative expenses | 21,348 | 23,667 | (2,320) | -9.8 | % | ||||||||||||||||||
General and Administrative expenses decreased by $2.3 million for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024.
This decrease derives from decrease in external professional services due to non-recurring costs incurred in 2024 associated with (1) office relocations in France and the United States, (2) financing activities and (3) activities related to the Company's and patents.
Employee-related costs increased by $0.4 million for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024. This increase is primarily due to recruitment having started during the second quarter of 2024.
Depreciation, amortization and other costs remain consistent for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024.
Financial income (expense)
Our financial income was $4 thousand for the nine months ended September 30, 2025, compared to a financial income of $1.9 million for the nine months ended September 30, 2024. This item includes the net interests yielded by our cash deposits offset by an unfavorable foreign exchange impact.
Income tax
Our income tax expense was $117 thousand for the nine months ended September 30, 2025, compared to $48 thousand for the nine months ended September 30, 2024.
Net loss
Net loss was $102.1 million for the nine months ended September 30, 2025, compared to $90.9 million for the nine months ended September 30, 2024. Net loss per share (based on the weighted average number of shares outstanding over the period) was $(0.82) and $(0.95) for the nine months ended September 30, 2025 and 2024, respectively.
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Liquidity and Capital Resources
Financial Condition
On September 30, 2025, we had $69.8 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 financing (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.
On April 7, 2025, the Company received gross proceeds of $125.5 million (€116.3 million) from the issuance of securities including, ABSAs and PFW-BS-PFWs, as described in the Company’s Quarterly Report on Form 10-Q for the Quarter ended March 31, 2025 filed with the SEC on April 30, 2025.
The Company may also receive an aggregate of up to $181.4 million (€168.2 million) in gross proceeds if all 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 the warrants. DBV expects that the proceeds of this funding will be used for working capital and general corporate purposes, to finance the continued development of the Viaskin Peanut program, to finance the preparation and submission of a potential Biologics License Application (“BLA”) and, to finance the readiness of a launch of Viaskin peanut in the US, if approved.
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 sell American Depositary Shares (“ADS”), from time to time, through Citizens as its sales agent. 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 (subject to French regulatory limits) from time to time through Citizens. 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. 333-271166). 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. Subsequent to the end of the third quarter, the Company also received a total gross amount of approximately $30 million from the sale of 11,538,460 Ordinary Shares (underlying 2,307,692 ADSs) received on October 6, 2025 pursuant to the ATM Offering.
As of the date of the filing, with the receipt of the aforementioned proceeds, and based on its current operations, plans, and assumptions examined by the Board on October 28, 2025, the Company estimates that its cash and cash equivalents are sufficient to fund its operations into the third quarter of 2026. These conditions and events raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that these financial statements are issued.
Sources of Liquidity and Material Cash Requirements
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 the Viaskin Peanut patch, 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 conflicts, 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.
25
Operating Leases
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 September 30, 2025 expenses associated with the ongoing trials amounted globally to $279.2 million compared to $170.3 million as of December 31, 2024.
This increase is mainly due to the launch of the COMFORT Toddlers study following alignment with the FDA, and the progress of the VITESSE phase 3 clinical study.
Purchase Obligations - Obligations Under the Terms of SANOFI Manufacturing and Supply Agreement
We have non-cancellable minimum commitments for products and services, subject to the Supply Agreement. They are reflected in Note 12.
Summary Statement of Cash Flows
The table below summarizes our sources and uses of cash for the nine months ended September 30, 2025 and 2024.
| Nine Months Ended September 30, | |||||||||||||||||||||||
| (Amounts in thousands of U.S. Dollars) | 2025 | 2024 | $ change | % of change | |||||||||||||||||||
| Net cash flow used in operating activities | (86,008) | (92,222) | 6,214 | (7) | % | ||||||||||||||||||
| Net cash flow used in investing activities | (654) | (1,550) | 896 | (58) | % | ||||||||||||||||||
| Net cash flows used in / provided by financing activities | 117,122 | (88) | 117,210 | (132641) | % | ||||||||||||||||||
| Effect of exchange rate changes on cash and cash equivalents | 6,921 | (1,065) | 7,987 | (750) | % | ||||||||||||||||||
| Net (decrease) increase in cash and cash equivalents | 37,381 | (94,925) | 132,307 | (139) | % | ||||||||||||||||||
Operating Activities
Our net cash flows used in operating activities were $86.0 million and $92.2 million during the nine months ended September 30, 2025 and 2024, respectively. Our net cash flows used in operating activities decreased by $6.2 million as our costs and expenses have been contained and payment terms extended during period covered by this report.
The decrease compared to last year is mainly due to (1) the deferral of Research & Development activities to support clinical trial progress through regulatory affairs, medical affairs, the manufacturing platform and procurement activities for $6.8 million, (2) General and Administration non-recurring costs incurred in 2024 associated with office relocations in France and the United States, financing activities, activities related to the Company's trademarks and patents and savings on insurance policies for $5.0 million, and (3) deferrals of Sales & Marketing activities by $0.8 million. This decrease is partially offset by the launch of the COMFORT Toddlers study following alignment with the FDA for $4.7 million.
Investing Activities
Our net cash flows used in investing activities were $0.7 million and $1.5 million during the nine months ended September 30, 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 $117.1 million for the nine months ended September 30, 2025 compared to $(88) thousand for the nine months ended September 30, 2024. This increase is due to the financing operation completed on April 7, 2025.
Off-Balance Sheet Arrangements
On August 29, 2025, the Company updated its Supply Agreement with SANOFI, under which SANOFI will manufacture and supply the Viaskin Peanut API exclusively for the Company during the Supply Agreement term. Under such, the Company has agreed to certain minimum purchase levels and service fees over the initial four-year-term.
As of September 30, 2025, total payments made during the period under the Agreement are approximately $5.9 million, which were recorded as R&D expenses.
Future purchase commitments as of September 30, 2025, are as follows and are consistent with the Company’s overall manufacturing and supply strategy in preparation for potential commercial launch activities.
in thousands USD | 2025 | 2026 | 2027 | 2028 | Total | |||||||||||||||
Commitments | 12,313 | 14,687 | 12,751 | 4,827 | 44,578 | |||||||||||||||
26
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 September 30, 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 time periods specified in the SEC’s rules and forms, and (ii) such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting identified in management’s evaluation pursuant to Rules 13a-15(d) or 15d-15(d) of the Exchange Act during the period covered by this Quarterly Report on Form 10-Q that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Limitation on Effectiveness of Controls and Procedures
Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision making can be faulty and that breakdowns can occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies and procedures. Because of the inherent limitations in a cost-effective control system, misstatements due to error of fraud may occur and not be detected.
27
PART II – OTHER INFORMATION
Item 1. Legal Proceedings
See “Note 2: Significant Events and Transactions – Legal Proceedings” in the notes to the condensed consolidated financial statements included elsewhere in this Quarterly Report.
Item 1A. Risk Factors
Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and trading price of our securities. In addition to the other information set forth in this Quarterly Report, you should carefully consider the factors described in Part I, Item 1A. “Risk Factors” of our Annual Report . Except as set forth below, there have been no material changes from our risk factors described in “Part I, Item 1A. Risk Factors” of our Annual Report on Form 10-K.While management has plans to address these issues, there is no assurance these plans will be successful, which could materially impact our business and financial condition.
There is uncertainty regarding our ability to maintain liquidity sufficient to operate our business effectively, which raises substantial doubt about our ability to continue as a going concern.
Our unaudited condensed consolidated financial statements as of September 30, 2025 have been prepared assuming the Company will continue as a going concern for the next twelve months. Our management concluded that our recurring losses from operations, existing unrestricted cash, and cash equivalents raise substantial doubt about our ability to continue as a going concern for the next twelve months after issuance of our financial statements included in this Quarterly Report on Form 10-Q. As of September 30, 2025, we had unrestricted cash, cash equivalents and marketable securities of $69.8 million consisting of cash and investments. Subsequent to September 30, 2025, we raised additional proceeds of approximately $30 million total gross proceeds through the Company’s ATM Offering. We do not expect our existing cash and cash equivalents will be sufficient to fund our operations through the next twelve months and we will need to seek additional capital to fund our operations, working capital needs, capital expenditures and other strategic initiatives beyond that time. Although management has been successful in raising capital in the past, there can be no assurance that we will be successful or that any needed financing will be available in the future at terms acceptable to us. As such, we cannot conclude that such plans will be effectively implemented within one year after the date that the financial statements included in this Quarterly Report on Form 10-Q and there is uncertainty regarding our ability to maintain liquidity sufficient to operate our business effectively, which raises substantial doubt about our ability to continue as a going concern.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
During the nine months ended September 30, 2025, we issued the following unregistered securities:
•On January 9, 2025, the issuance of an aggregate of 7,300 ordinary shares to U.S. employees upon settlement of RSUs;;
•On January 29, 2025, the issuance of an aggregate of 1,462 ordinary shares to U.S. employees upon settlement of RSUs;
•On March 23, 2025, the issuance of an aggregate of 2,605 ordinary shares to U.S. and non-U.S. employees upon settlement of RSUs;
•On March 27, 2025, we entered into the Securities Purchase Agreements with Investors to which we agreed to issue and sell to the Investors (i) 34,090,004 New Shares, each with ABSA Warrants at a subscription price of €1.1136 per ABSA, and (ii) 71,005,656 First Pre-Funded Warrants at a subscription price of €1.1036 (which equals the per New Share subscription price less the exercise price of €0.01), which was completed on April 7, 2025;
•On May 12, 2025, the issuance of an aggregate of 400 ordinary shares to U.S. employees upon settlement of RSUs;
•On May 19, 2025, the issuance of an aggregate of 2,500 ordinary shares to non-U.S. employees upon settlement of RSUs;
•On May 22, 2025, the issuance of an aggregate of 21,925 ordinary shares to U.S. and non-U.S. employees upon settlement of RSUs; and
•On July 29, 2025, the issuance of an aggregate of 1,462 ordinary shares to U.S. employees upon settlement of RSUs.
None of the foregoing transactions involved any underwriters, underwriting discounts or commissions, or any public offering. We believe these transactions were exempt from registration under the Securities Act in reliance on Section 4(a)(2) of the Securities Act or Regulation S promulgated under Section 5 of the Securities Act, as transactions by an issuer not involving any public offering or as offerings made to non-U.S. resident employees pursuant to an employee benefit plan established and administered in accordance with the law of a country other than the United States (namely, the Republic of France) and in accordance with that country’s practices and documentation. All recipients had adequate access, through their relationships with us, to information about us. The sales of these securities were made without any general solicitation or advertising.
Item 3. Defaults Upon Senior Securities
None.
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Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
During the three months ended September 30, 2025, none of our directors and officers (as defined in Rule16a-1(f) under the Securities Exchange Act of 1934, as amended) adopted terminated
Item 6. Exhibits
Exhibit Index
| Exhibit | Description | Incorporated by Reference | |||||||||||||||
| Schedule/ Form | File Number | Exhibit | File Date | ||||||||||||||
| 3.1 | |||||||||||||||||
| 31.1 | |||||||||||||||||
| 31.2 | |||||||||||||||||
| 32.1* | |||||||||||||||||
| 101.INS | XBRL Instance Document | ||||||||||||||||
| 101.SCH | XBRL Taxonomy Extension Schema Document | ||||||||||||||||
| 101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document | ||||||||||||||||
| 101.DEF | XBRL Taxonomy Extension Definition Linkbase Document | ||||||||||||||||
| 101.LAB | XBRL Taxonomy Extension Labels Linkbase Document | ||||||||||||||||
| 101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document | ||||||||||||||||
| 104 | Cover Page Interactive Data File, formatted in Inline XBRL and contained in Exhibit 101. | ||||||||||||||||
*Furnished herewith and not deemed to be “filed” for purposes of Section 18 of the Exchange Act, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Form 10-Q), irrespective of any general incorporate language contained in such filing. | |||||||||||||||||
SIGNATURES
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Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
DBV Technologies S.A. (Registrant) | ||||||||
Date: October 28, 2025 | By: | /s/ Daniel Tassé | ||||||
| Daniel Tassé | ||||||||
| Chief Executive Officer | ||||||||
| (Principal Executive Officer) | ||||||||
Date: October 28, 2025 | By: | /s/ Virginie Boucinha | ||||||
Virginie Boucinha | ||||||||
| Chief Financial Officer | ||||||||
| (Principal Financial and Accounting Officer) | ||||||||
30
Exhibit 31.1
Certification by the Chief Executive Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Daniel Tassé, certify that:
1.I have reviewed this quarterly report on Form 10-Q of DBV Technologies S.A.;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c)Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d)Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: October 28, 2025
| /s/ Daniel Tassé | ||||||||
| Daniel Tassé | ||||||||
| Chief Executive Officer | ||||||||
| (Principal Executive Officer) | ||||||||
Exhibit 31.2
Certification by the Chief Financial Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Virginie Boucinha, certify that:
1.I have reviewed this quarterly report on Form 10-Q of DBV Technologies S.A.;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c)Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: October 28, 2025
| /s/ Virginie Boucinha | ||||||||
| Virginie Boucinha | ||||||||
| Chief Financial Officer | ||||||||
| (Principal Financial and Accounting Officer) | ||||||||
Exhibit 32.1
Certification by the Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. § 1350), Daniel Tassé, Chief Executive Officer of DBV Technologies S.A. (the “Company”), and Virginie Boucinha, Chief Financial Officer of the Company, each hereby certifies that, to the best of his knowledge:
1.The Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2025, to which this Certification is attached as Exhibit 32.1 (the “Quarterly Report”), fully complies with the requirements of Section 13(a) and Section 15(d) of the Exchange Act, and
2.The information contained in the Quarterly Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: October 28, 2025
| /s/ Daniel Tassé | /s/ Virginie Boucinha | |||||||
| Daniel Tassé | Virginie Boucinha | |||||||
| Chief Executive Officer | Chief Financial Officer | |||||||
| (Principal Executive Officer) | (Principal Financial and Accounting Officer) | |||||||
This certification accompanies the Quarterly Report, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Quarterly Report), irrespective of any general incorporation language contained in such filing.