DBV Technologies S.A 10-Q for FY2026 Q3
DBV Technologies S.A. (DBVT)
10-Q
2026-10-28
For: 2026-09-30
View Original
Added on
October 28, 2026
About this 10-Q
DBV Technologies S.A filed this 10-Q on October 28, 2026, covering the quarter ended September 30, 2026 (FY2026 Q3).
DBV Technologies S.A. submitted its BLA for VIASKIN Peanut in children ages 4 through 7 on September 29, 2026, requested Priority Review, and reported a $162.5 million nine-month net loss, $165.7 million cash, and runway into the third quarter of 2027. AI summary
Headline figures
Quarter ended September 30, 2026, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $1.6M
- down 42.9% from $2.8M a year earlier
- Net loss
- $64.5M
- compared with a net loss of $33.2M a year earlier
- Diluted EPS
- -$0.14
- compared with -$0.24 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, 2026
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) | ||||
with a copy to: | |||||
10 Independence Blvd. Suite 302 | |||||
Warren, New Jersey 07059 | |||||
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 26, 2026, the registrant had 314,388,807 ordinary shares, nominal value €0.10 per share, outstanding including treasury shares.
Table of contents
Part I | 2 | |||||||
Item 1 | 2 | |||||||
3 | ||||||||
Condensed Consolidated Statements of Cash Flows (Unaudited) for the Nine Months Ended September 30, 2026 and 2025 | 4 | |||||||
Condensed Consolidated Statements of Changes in Shareholders’ Equity (Unaudited) as of September 30, 2026 and 2025 | 5 | |||||||
6 | ||||||||
Item 2 | 20 | |||||||
Item 3 | 27 | |||||||
Item 4 | 27 | |||||||
Part II | 28 | |||||||
Item 1 | 28 | |||||||
Item 1A | 28 | |||||||
Item 2 | 28 | |||||||
Item 3 | 28 | |||||||
Item 4 | 28 | |||||||
Item 5 | 28 | |||||||
Item 6 | 28 | |||||||
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 (“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 submissions, filings, and approvals, including with respect to our Biologics License Application (“BLA”) for VIASKIN Peanut patch in 4-7 year olds and 1-3 year olds 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 the timing and anticipated support for the BLA submission to FDA for VIASKIN Peanut patch in 1 - 3 year olds;
•our expectations regarding initiation of the confirmatory effectiveness study for VIASKIN Peanut patch in 1 - 3 year olds;
•anticipated support for the BLA review for VIASKIN Peanut patch in 4 - 7 year olds;
•our expectations with respect to the grant of Priority Review designation by FDA for BLA for VIASKIN Peanut patch in 4 - 7 year olds;
•the timing and anticipated results of interactions with regulatory agencies;
•the design, initiation, timing, progress, results and success of our pre-clinical studies and clinical trials, and our research and development programs;
•the sufficiency of existing capital resources;
•our business model and our other strategic plans for our business, product candidates and technology;
•our ability to manufacture clinical and commercial supplies of VIASKIN Peanut patch and/or our other product candidates and comply with regulatory requirements related to the manufacturing of our product candidates, if approved;
•the ability of our sole contract manufacturer for VIASKIN Peanut patches to successfully remediate Good Manufacturing Practice deficiencies in response to FDA warning letters;
•our ability to build our own sales and marketing capabilities, or seek collaborative partners, to commercialize 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 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 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;
•expectations with respect to cash runway;
•our future financial performance;
•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, 2025, filed with the Securities and Exchange Commission (“SEC”) on March 26, 2026, as amended by the Amendment No. 1 on Form 10-K/A filed with the SEC on April 30, 2026 (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 millions, except share and per share data)
| Note | September 30, 2026 | December 31, 2025 | |||||||||||||||
| Assets | |||||||||||||||||
| Current assets : | |||||||||||||||||
| Cash and cash equivalents | 3 | ||||||||||||||||
| Other current assets | 5 | ||||||||||||||||
| Total current assets | |||||||||||||||||
| Property, plant, and equipment, net | 4 | ||||||||||||||||
| Right-of-use assets | 6 | ||||||||||||||||
| Other non-current assets | 5 | ||||||||||||||||
| Total non-current assets | |||||||||||||||||
| Total Assets | |||||||||||||||||
| Liabilities and shareholders' equity | |||||||||||||||||
| Current liabilities: | |||||||||||||||||
| Trade payables | 7 | ||||||||||||||||
| Short-term operating leases' liabilities | 6 | ||||||||||||||||
| Current contingencies & Employee Benefits | 11 | ||||||||||||||||
| Other current liabilities | 7 | ||||||||||||||||
| Total current liabilities | |||||||||||||||||
| Long-term operating leases' liabilities | 6 | ||||||||||||||||
| Long-term financial debt | |||||||||||||||||
| Non-current contingencies & Employee Benefits | 11 | ||||||||||||||||
| Total non-current liabilities | |||||||||||||||||
| Total Liabilities | |||||||||||||||||
| Shareholders’ equity : | 8 | ||||||||||||||||
Ordinary shares, € | |||||||||||||||||
| Additional paid-in capital | |||||||||||||||||
Treasury stock, | ( | ( | |||||||||||||||
| Accumulated deficit | ( | ( | |||||||||||||||
| Accumulated other comprehensive income | |||||||||||||||||
| Accumulated currency translation effect | ( | ( | |||||||||||||||
| Total Shareholders’ equity | |||||||||||||||||
| 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 millions, except share and per share data)
| Note | Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||||||||||||||||
| Operating income | 12 | $ | $ | $ | $ | ||||||||||||||||||||||||
| Operating expenses | 13/17 | ||||||||||||||||||||||||||||
| 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 | 16 | $ | ( | $ | ( | $ | ( | $ | ( | ||||||||||||||||||||
| Weighted average shares outstanding used in computing per share amounts: | 16 | ||||||||||||||||||||||||||||
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 millions)
| Notes | Nine Months Ended September 30, | ||||||||||||||||
| 2026 | 2025 | ||||||||||||||||
| Net loss for the period | $ | ( | $ | ( | |||||||||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||||||||
| Depreciation, amortization and accrued contingencies | 4/11 | ||||||||||||||||
| Expenses related to share-based payments | 10 | ||||||||||||||||
| Inventory write-downs | |||||||||||||||||
| Other | |||||||||||||||||
| Changes in operating assets and liabilities: | |||||||||||||||||
| Decrease (increase) in inventories and work in progress | ( | ( | |||||||||||||||
| Decrease (increase) in other current assets | 5 | ( | ( | ||||||||||||||
| (Decrease) increase in trade payables | 7 | ||||||||||||||||
| (Decrease) increase in other current and non-current liabilities | ( | ( | |||||||||||||||
| Change in operating lease liabilities and right of use assets | 6 | ||||||||||||||||
| Net cash flow used in operating activities | ( | ( | |||||||||||||||
| Cash flows used in investing activities : | |||||||||||||||||
| Change in property, plant, and equipment | 4 | ( | ( | ||||||||||||||
| Change in Other non-current assets | 5 | ( | ( | ||||||||||||||
| Net cash flows used in investing activities | ( | ( | |||||||||||||||
| Cash flows provided by financing activities : | |||||||||||||||||
| Treasury shares | ( | ||||||||||||||||
| Issuance from Net Capital increase and Share warrants | 8 | ||||||||||||||||
| Other cash flows related to financing activities | |||||||||||||||||
| 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 | ( | ||||||||||||||||
| Net Cash and cash equivalents at the beginning of the period | 3 | ||||||||||||||||
| Net cash and cash equivalents at the end of the period | 3 | $ | |||||||||||||||
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 millions, 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, 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 | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Allocation of accumulated net losses | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance at September 30, 2025 | ( | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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, 2026 | $ | $ | $ | ( | $ | ( | $ | $ | ( | $ | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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, 2026 | $ | $ | $ | ( | $ | ( | $ | $ | ( | $ | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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, 2026 | $ | $ | $ | ( | $ | ( | $ | $ | ( | $ | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net (loss) | — | 0 | — | — | — | — | — | — | ( | — | — | — | — | — | ( | |||||||||||||||||||||||||||||||||||||||||||||||
| Other comprehensive income (loss) | — | 0 | — | — | — | — | — | — | — | — | — | ( | — | ( | ||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of ordinary shares | 0 | — | — | — | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of share warrants | — | 0 | — | — | — | — | — | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||
| Treasury shares | — | 0 | — | — | — | — | ( | — | — | — | — | — | — | — | ( | |||||||||||||||||||||||||||||||||||||||||||||||
| Share-based payments | — | 0 | — | — | — | — | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||
| Allocation of accumulated net losses | — | 0 | — | — | — | — | — | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||
| Other change in equity | 0 | — | — | — | — | — | — | — | — | — | — | ( | — | |||||||||||||||||||||||||||||||||||||||||||||||||
| Balance at September 30, 2026 | $ | $ | $ | ( | $ | ( | $ | $ | ( | $ | ||||||||||||||||||||||||||||||||||||||||||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
6
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
Note 1 Nature of the business and principles and accounting methods
Incorporated in 2002 under the laws of France, DBV Technologies S.A. (“DBV Technologies,” or the “Company”, “we”, or the “group”) is a late-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin. The Company’s therapeutic approach is based on epicutaneous immunotherapy (“EPIT”), a proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin.
Basis of Presentation
The condensed consolidated financial statements of the Company and its wholly-owned subsidiaries are unaudited and have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) and are presented in U.S. dollars. All 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 March 26, 2026, as amended by Amendment No. 1 on Form 10-K/A filed with the SEC on April 30, 2026. The condensed consolidated statement of financial position as of December 31, 2025 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, 2025.
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, 2026, or any other future period.
The Company presents all financial statement amounts in millions. This presentation has been applied consistently to all periods presented, with prior‑period amounts presented on the same basis. No rounding adjustments were required, and the change did not affect comparability.
Recently Adopted Accounting Pronouncements
Accounting Pronouncements Issued Not Yet Adopted
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. Management evaluated the impact of adopting ASU 2024‑03 and determined that its adoption will result on expanded disclosures on the Company’s consolidated financial statements.
In December 2025, the FASB issued ASU 2025‑12, Codification Improvements, which includes a series of technical corrections, clarifications, and minor improvements to existing guidance across various Topics in the FASB Accounting Standards Codification. The amendments are not expected to significantly affect current accounting practices. ASU 2025‑12 is effective for annual and interim reporting periods beginning after December 15, 2026. The Company does not expect the adoption of ASU 2025-12 to have a material impact on its consolidated financial statements.
In December 2025, the FASB also issued ASU 2025‑11, Interim Reporting (Topic 270): Narrow‑Scope Improvements, which clarifies the scope and applicability of interim reporting guidance, enhances the organization and navigability of required interim disclosures, and introduces a disclosure principle requiring entities to disclose material events or changes that occur after the most recent annual reporting period. For public business entities, the ASU is effective for interim reporting periods in fiscal years beginning after December 15, 2027 with early adoption permitted. The Company does not expect ASU 2025-11 to have a material impact on its interim consolidated financial statements.
In December 2025, the FASB issued ASU 2025‑10, Government Grants (Topic 832): Accounting for Government Grants Received by Business Entities, which establishes authoritative U.S. GAAP guidance for the recognition, measurement, presentation, and disclosure of government grants received by business entities. The amendments are effective for public business entities for annual reporting periods beginning after December 15, 2028, including interim periods within those annual periods, with early adoption permitted. The Company does not expect ASU 2025-10 to have a material impact on its consolidated financial statements.
In April 2026, the FASB issued ASU 2026‑01, Equity (Topic 505): Initial Measurement of Paid‑in‑Kind Dividends on Equity‑Classified Preferred Stock. The ASU provides authoritative guidance on the initial measurement of paid‑in‑kind (“PIK”) dividends issued on equity‑classified preferred stock, addressing diversity in practice. Under the amendments, PIK dividends are required to be initially measured based on the PIK dividend rate stated in the preferred stock agreement, typically applied to the liquidation value of the preferred stock outstanding. The guidance does not affect the determination of when PIK dividends are recognized. The ASU is effective for annual reporting periods beginning after December 15, 2026, including interim periods
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within those fiscal years, with early adoption permitted. The amendments may be applied on either a prospective basis or a modified retrospective basis. The Company does not expect ASU 2026-01 to have a material impact on its consolidated financial statements.
In May 2026, the FASB issued ASU 2026‑02, introducing a comprehensive framework for the accounting of environmental credits and related obligations. The standard requires entities to recognize environmental credits as assets only when it is probable that they will be used to settle obligations or otherwise transferred, with all other credits expensed as incurred. Measurement is primarily based on cost, with subsequent accounting depending on the intended use of the credits. The ASU also establishes a liability model for environmental credit obligations, measured based on available credits (funded portion) or the cost or fair value of credits to be acquired (unfunded portion). The guidance is effective for public business entities for fiscal years beginning after December 15, 2027, with early adoption permitted. The Company does not expect ASU 2026-02 to have a material impact on its consolidated financial statements.
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 estimates and assumptions, developed based on the information available at the time of closing the accounts, particularly relate to:
•The assessment of the fair value of equity-settled share-based compensation plans granted to employees and/or executives, which is performed using actuarial models. These models require the Company to use certain calculation assumptions, such as the expected volatility of the share price and the estimated timing of achieving performance conditions over the vesting period of the share-based compensation plan;
•The evaluation of the amount of the Research Tax Credit, which is based on eligible internal and external research expenses incurred by the Company during the fiscal year. Only eligible research expenditures are included in the calculation of the Research Tax Credit;
•The recoverability of the Company’s net deferred tax assets and related valuation allowance;
•The assumptions used in the valuation of right-of-use assets & operating leases; and
•The estimate of provisions and contingencies.
The final amounts may differ from these estimates. Management is also required to exercise judgment in the following area:
Going Concern
These condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and the satisfaction of liabilities in the normal course of business for at least twelve months from the date of issuance of these condensed consolidated financial statements.
The Company has incurred operating losses and negative cash flows from operations since inception and expects operating cash outflows to remain significant as it continues to invest in clinical development, regulatory activities, manufacturing and supply-chain readiness and preparations for the potential commercialization of VIASKIN Peanut patch, if approved. Net cash used in operating & investing activities was $159.4 million for the nine months ended September 30, 2026, compared to $86.7 million for the nine months ended September 30, 2025, reflecting the continued advancement of these activities and the expansion of the Company’s organization.
As of September 30, 2026, the Company had cash and cash equivalents of $165.7 million. During the third quarter of 2026, the Company achieved significant regulatory and financing milestones, including the submission of its BLA for VIASKIN Peanut patch in children ages 4 through 7 on September 29, 2026, for which the Company requested Priority Review, and the completion of a sale of $50.0 million in gross proceeds of ADSs under its ATM Program announced by the Company in July 2026. Following the BLA submission, management updated the Company’s operating and liquidity forecasts to reflect the potential regulatory review pathway and the anticipated timing of related clinical, regulatory, manufacturing and commercial readiness activities. The Company’s forecasts incorporate milestone-based spending assumptions designed to align the timing of certain expenditures with potential regulatory developments while continuing to advance activities necessary to support regulatory review and potential commercialization of VIASKIN Peanut patch in children ages 4 through 7, if approved. Based on its current operations, plans and assumptions, the Company estimates that its existing cash and cash equivalents will be sufficient to fund operations into the third quarter of 2027.
As such, Management has concluded that the Company's existing cash and cash equivalents are not sufficient to fund its operations for at least twelve months from the date of issuance of these interim condensed consolidated financial statements. Accordingly, substantial doubt exists about the Company's ability to continue as a going concern within twelve months after the date these condensed consolidated financial statements are issued.
The Company will require additional capital to fund its operations. Management is actively evaluating multiple financing alternatives, including, without limitation, potential additional sales under the Company’s existing ATM Program, equity transactions, warrants exercise and other alternative forms of financing. The Company’s continued advancement through the regulatory review process may provide additional financing opportunities. However, the availability, timing and terms of any additional financing will depend on regulatory developments, market conditions and investors’ interest, lenders and other counterparties, and there can be no assurance that additional financing will be available when needed, on acceptable terms or at all.
These estimates are based on the Company’s current forecasts and exclude additional expenditures related to programs other than VIASKIN Peanut patch or resulting from the potential in-licensing or acquisition of additional product candidates or technologies. The timing and amount of the Company’s future cash requirements may differ materially from current estimates depending on, among other factors, the timing and outcome of the regulatory review process, the pace of clinical development activities, manufacturing and supply-chain commitments, commercial readiness activities and foreign exchange rate fluctuations. These condensed consolidated financial statements do not include any adjustments to the carrying amounts and classification of assets and liabilities or reported expenses that may be necessary if the Company were unable to continue as a going concern.
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Significant contracts
March 2025 PIPE Financing
March 2025 PIPE Financing
In March 2025, the Company completed a private investment in public equity financing generating initial gross proceeds of $125.5 million (€116.3 million) received on April 7, 2025 (“March 2025 PIPE Financing”). Following the announcement of positive VITESSE topline results on December 16, 2025, the warrants issued in connection with the March 2025 PIPE Financing were fully exercised, resulting in additional gross proceeds of $195.4 million (€166.7 million at the exchange rate of 1 EUR = $1.17 ), of which $100.7 million (€85.7 million) was received in the fourth quarter of 2025 and $94.7 million (€81.0 million) was received in January 2026.
The pre-funded warrants issued in connection with the March 2025 PIPE Financing were classified as equity under ASC 480 and ASC 815. Upon exercise, the par value of the newly issued common stocks was recorded in “Common stock” and any additional amount, including the exercise price paid and the remaining carrying amount of the warrants, was recorded in “Additional paid-in capital”. No gain or loss was recognized in the Consolidated Statements of Operations and Comprehensive Loss as the warrants were classified as equity from inception.
Fareva La Vallée - Manufacturing Infrastructure Agreements
The Company entered strategic manufacturing arrangements with Fareva La Vallée ("FLV") to secure dedicated manufacturing capacity for both Peanut Source Material ("PSM") and Peanut Drug Substance ("PDS"), supporting the future commercial supply chain for VIASKIN Peanut.
Peanut Source Material
On March 17, 2026, the Company entered into a Manufacturing and Supply Agreement (the “MS Agreement”) with FLV, under which FLV will manufacture and supply the VIASKIN PSM, exclusively for the Company during the MS Agreement term. The term is effective for a period of eight (8 ) years and can be renewed for a period of two (2 ) years.
The MS Agreement is subsequent to the Service Agreement that the Company entered into with FLV on March 18, 2024 (the “PSM Services Agreement”), for the construction of a dedicated production line and facility and the transfer of manufacturing of the PSM to FLV required to produce VIASKIN Peanut patches. The PSM Services Agreement also included binding commercial terms which were incorporated into the MS Agreement.
The PSM Services Agreement includes the following services (i) construction activities, (ii) the acquisition of equipment, and (iii) the cGMP qualification of a dedicated PSM production line installed at FLV’s premises. The Company has funded capital expenditures amounting to $4.1 million (at the exchange rate of 1€ = $1.14 ), granting access to preferential pricing and to an exclusively dedicated PSM production line located at FLV’s facilities, while ownership of the line remains with FLV.
Peanut Drug Substance
On July 8, 2026, the Company entered into a PDS Services Agreement and Binding Commercial Term Sheet with FLV relating to the construction development, installation and qualification of a dedicated PDS manufacturing line, as well as related transfer services for technical and validation batches.
The PDS facility services are expected to be completed no later than September 30, 2027, and the transfer services no later than September 1, 2028. The Company’s commitments under the agreement include PDS facility services fees capped at $3.9 million (at the exchange rate of 1€ = $1.14 ), of which the Company funded $3.3 million (at the exchange rate of 1€ = $1.14 ). These fees, exclude certain capital expenditures directly supported by the Company, and transfer services fees are capped at $3.2 million (at the exchange rate of 1€ = $1.14 ). The agreement also includes binding commercial terms expected to be incorporated into a future definitive manufacturing and supply agreement.
Accounting Treatment
Management has concluded that both the PSM and PDS arrangements contain embedded leases within the scope of ASC 842, Leases, based on the following considerations:
•Identified asset: The dedicated PSM & PDS production lines are identified assets, and FLV does not have substitution rights.
•Control of use: The Company has (i) the right to obtain substantially all of the economic benefits from use of the asset, through exclusive access to the production capacity, and (ii) the right to direct the use of the asset, including decision‑making authority over relevant activities such as production volumes, scheduling, and operating methods.
In accordance with ASC 842‑10‑25‑2, the right‑of‑use assets will be recognized at the lease commencement date, defined as the date on which the production lines are made available for use following completion of cGMP qualification. At this stage, the Company has identified the embedded leases, the separation of lease and non‑lease components of the arrangements, and the reclassification of the payment related to the exclusive access right as prepaid rent under ASC 842 (Other non-current assets). Subsequent to September 30, 2026, the first commercial PSM batch was successfully manufactured by FLV and incorporated into the pre-commercial inventory. Accordingly, management expects lease commencement to occur during the fourth quarter of 2026 and amortization of the PSM right-of-use asset to begin during the fourth quarter of 2026.
Under the PSM Manufacturing and Supply Agreement, the Company is subject to minimum purchase commitments tied to the commercial supply of PSM. Specifically, if cumulative commercial orders are below 940 kilograms at the end of the 36-month period following delivery of the first commercial batch, the Company may be required to compensate FLV for the shortfall, subject to a contractual cap of $0.6 million (at the exchange rate of 1€ = $1.14 ). Based on management's operational forecasts as of September 30, 2026, the Company expects to meet the purchase obligations and therefore did not record any liability or accrual related to these commitments
Note 2 Significant Events and Transactions
Amendment to the Letter of intent signed with Fareva Amboise
On September 30, 2026, the Company entered into Amendment No. 1 to its June 25, 2026 Letter of Intent with Fareva Amboise concerning
On September 30, 2026, the Company entered into Amendment No. 1 to its June 25, 2026 Letter of Intent with Fareva Amboise concerning
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manufacturing readiness activities supporting the future commercial-scale manufacture of the VIASKIN Peanut patch. The planned investment is estimated at $5.5 million (at the exchange rate of 1€ = $1.14 ). Under the amendment, the Company's $1.1 million (at the exchange rate of 1€ = $1.14 ) upfront contribution to this project was modified such that payment is no longer contingent upon FDA approval of the Company's Biologics License Application. Instead, payment is contingent upon the successful completion of an independent Mock Pre-Approval Inspection, including the absence of critical findings or repeat observations and remediation of all findings by February 1, 2027.
In addition, the amendment finalized and secured the workforce expansion component of the project, including training and extended readiness activities. These personnel are dedicated to supporting industrial ramp-up, execution of the remediation plan and commercial manufacturing preparedness. The parties continue to negotiate a definitive commercial manufacturing and supply agreement. The Company expects the amended arrangement to support the timely execution of manufacturing readiness activities and further prepares the Amboise facility for future commercial production of VIASKIN® Peanut, if approved, including activities necessary to support a successful FDA pre-approval inspection.
Submission of BLA FDA for the VIASKIN® Peanut Patch in Children Aged 4-7 Years
On September 29, 2026, the Company announced the submission of a BLA to FDA seeking approval of the VIASKIN® Peanut patch for the treatment of peanut allergy in children aged 4 through 7 years. The submission is supported by data from the Phase 3 VITESSE study, a randomized, double-blind, placebo-controlled trial, which enrolled654 children. The Company has requested Priority Review designation, which, if granted, would reduce the standard review period from to six months . The FDA has 60 days from the submission date to determine whether the BLA is sufficiently complete to permit substantive review, following which the Company anticipates receipt of a Prescription Drug User Fee Act (“PDUFA”) target action date. The BLA filing represents a significant regulatory milestone and an important step toward the potential commercialization of VIASKIN Peanut patch in the United States. There can be no assurance that the FDA will accept the BLA for filing, grant Priority Review, or ultimately approve the VIASKIN Peanut patch.
On September 29, 2026, the Company announced the submission of a BLA to FDA seeking approval of the VIASKIN® Peanut patch for the treatment of peanut allergy in children aged 4 through 7 years. The submission is supported by data from the Phase 3 VITESSE study, a randomized, double-blind, placebo-controlled trial, which enrolled
In connection with the BLA submission, $4.7 million of previously deferred BLA-related costs were recognized as research and development expense during the quarter.
Shelf Registration Statement, ATM Program Refresh and Sale of $50 million in gross proceeds under ATM Program
On July 27, 2026, the Company filed an automatically effective shelf registration statement on Form S-3 ASR with the SEC. The shelf registration statement permits the Company to sell, from time to time, ordinary shares, American Depositary Shares (“ADSs”) representing ordinary shares and warrants. At the time of filing the shelf registration statement, the Company also filed a prospectus supplement with the SEC authorizing the sale of up to $150.0 million of ADSs under its existing at-the-market offering program (the "ATM Program") and shelf registration statement. On August 3, 2026, the Company announced the sale of $50.0 million in gross proceeds of ADSs to RA Capital Management, L.P. under the ATM Program. In connection with this transaction, the Company issued 18,288,220 new ordinary shares, underlying 3,657,644 new ADSs, at an at-the-market price of $13.67 per ADS.
On July 27, 2026, the Company filed an automatically effective shelf registration statement on Form S-3 ASR with the SEC. The shelf registration statement permits the Company to sell, from time to time, ordinary shares, American Depositary Shares (“ADSs”) representing ordinary shares and warrants. At the time of filing the shelf registration statement, the Company also filed a prospectus supplement with the SEC authorizing the sale of up to $
The net proceeds from the offering were recorded as an increase to shareholders' equity, net of issuance costs, in the condensed consolidated statements of financial position.
Services Agreement with Fareva La Vallée - Peanut Drug Substance
On July 8, 2026, the Company entered into a PDS Services Agreement and Binding Commercial Term Sheet with FLV relating to the construction development, installation and qualification of a dedicated PDS manufacturing line, as well as related transfer services for technical and validation batches.
On July 8, 2026, the Company entered into a PDS Services Agreement and Binding Commercial Term Sheet with FLV relating to the construction development, installation and qualification of a dedicated PDS manufacturing line, as well as related transfer services for technical and validation batches.
Letter of intent signed with Integrated Commercialization Solutions
On June 5, 2026, the Company entered into a Letter of Intent with Integrated Commercialization Solutions, LLC ("ICS") in connection with future commercialization support and distribution services for the VIASKIN Peanut patch in the United States, if approved. Under the letter of intent, the parties agreed to undertake certain preliminary launch readiness and implementation planning activities while continuing negotiations toward a definitive commercial outsourcing services agreement. The contemplated activities include operational planning, systems readiness, distribution infrastructure preparation and other commercialization support services intended to facilitate a potential future product launch, if approved.
On June 5, 2026, the Company entered into a Letter of Intent with Integrated Commercialization Solutions, LLC ("ICS") in connection with future commercialization support and distribution services for the VIASKIN Peanut patch in the United States, if approved. Under the letter of intent, the parties agreed to undertake certain preliminary launch readiness and implementation planning activities while continuing negotiations toward a definitive commercial outsourcing services agreement. The contemplated activities include operational planning, systems readiness, distribution infrastructure preparation and other commercialization support services intended to facilitate a potential future product launch, if approved.
As of September 30, 2026, negotiations of the definitive agreement remained ongoing and no material amounts had been incurred by the Company under the letter of intent. Management expects execution of the definitive agreement by the end of 2026. Accordingly, the arrangement has no material impact on the Company's condensed consolidated financial statements as of September 30, 2026.
Manufacturing Supply Agreement (Peanut Source Material) with Fareva La Vallée
On March 17, 2026, the Company entered into the MS Agreement with FLV, under which FLV will manufacture and supply the PSM exclusively for DBV Technologies S.A. during the agreement term. The term is effective for a period of eight (8 ) years and can be renewed for a period of two (2 ) years.
On March 17, 2026, the Company entered into the MS Agreement with FLV, under which FLV will manufacture and supply the PSM exclusively for DBV Technologies S.A. during the agreement term. The term is effective for a period of eight (
March 2025 PIPE Financing
On January 16, 2026, the Company received the supplemental gross proceeds of $94.7 million (€81.0 million) resulting in the full exercise of the warrants to purchase 34,090,004 new shares at a par value of €0.10 (the “ABSA Warrants”) and of the warrants to subscribe for 1.75 shares of the Company (the “BS Warrants”) issued in the March 2025 PIPE Financing.
On January 16, 2026, the Company received the supplemental gross proceeds of $
Administrative Proceedings
During the second quarter of 2026, the Company received notice from the French tax authorities of a routine, not-for-cause tax audit covering fiscal years 2022 through 2025. During the third quarter of 2026, the Company addressed and resolved all matters raised to date by the tax authorities. The audit remains ongoing, and the Company continues to cooperate fully with the Tax administration.
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Note 3 Cash and Cash Equivalents
The following tables summarize the Cash and Cash Equivalents as of September 30, 2026 and December 31, 2025:
| September 30, 2026 | December 31, 2025 | ||||||||||
| Cash | |||||||||||
| Cash Equivalents | |||||||||||
| Total Cash and Cash Equivalents | |||||||||||
Cash and cash equivalents totaled $165.7 million and $194.2 million as of September 30, 2026 and December 31, 2025, respectively.
During the period, the Company raised capital through two equity transactions. In July 2026, the Company announced $50.0 million in gross proceeds from the sale of American Depositary Shares (ADSs) to RA Capital Management, L.P. under the At-the-Market (ATM) Program. Additionally, in January 2026, the Company received $94.7 million in gross proceeds resulting from the acceleration and full exercise of the ABSA Warrants and BS Warrants originally issued in connection with the March 2025 PIPE Financing. The proceeds from both equity transactions supported the Company's operating and investing activities during the period.
As of September 30, 2026 cash equivalents totaled $110.7 million, compared to $67.1 million as of December 31, 2025. Cash equivalents consist primarily of short-term interest-bearing deposits with original maturities of three months or less when purchased. Management considers all investments to be readily convertible into known amounts of cash and subject to an insignificant risk of changes in value. Accordingly, they are classified as cash equivalents.
The Company actively manages its liquidity by investing excess cash balances in highly liquid, low-risk instruments while maintaining sufficient flexibility to fund operating activities, clinical development programs, manufacturing and supply-chain readiness activities, and potential commercial launch preparations.
Note 4 Property, Plant & Equipment
Property and equipment, net consisted of the following:
| December 31, 2025 | Currency translation effect | Increase | Decrease | September 30, 2026 | ||||||||||||||||
| Laboratory equipment | ( | |||||||||||||||||||
| Fixture and installations | ||||||||||||||||||||
| Computer equipment | ( | |||||||||||||||||||
| Other property, plant and equipment | ||||||||||||||||||||
| Property, plant, and equipment in progress | ( | |||||||||||||||||||
| Total, gross | ( | |||||||||||||||||||
| Accumulated depreciation of laboratory equipment | ( | ( | ( | |||||||||||||||||
| Accumulated depreciation of fixtures and installations | ( | ( | ( | |||||||||||||||||
| Accumulated depreciation of computer equipment | ( | ( | ( | |||||||||||||||||
| Accumulated depreciation of other property, plant and equipment | ( | ( | ||||||||||||||||||
| Less accumulated amortization and depreciation | ( | ( | ( | |||||||||||||||||
| Total, net | ( | |||||||||||||||||||
The increase in Property, Plant & Equipment for $3.3 million is driven by additions relating to ongoing Capacity expansion projects.
Note 5 Other Current & Non Current Assets
The following tables summarize the Other Current & Non Current Assets as of September 30, 2026 and December 31, 2025:
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| September 30, 2026 | December 31, 2025 | ||||||||||
| Prepaid Right of Use Asset | |||||||||||
| Deposits, pledged securities and other non-current financial assets | |||||||||||
| Liquidity contract | |||||||||||
Total Other non-current assets | |||||||||||
Research tax credit | |||||||||||
VAT Assets | |||||||||||
Prepaid and deferred expenses | |||||||||||
Other receivables | |||||||||||
| Total Other Current Assets | |||||||||||
Prepaid Right of Use Asset
The $7.4 million included the $4.1 million prepaid rent of the dedicated PSM production line and the $3.3 million prepaid rent of the dedicated PDS production line located at Fareva La Vallée’s facilities.
The right‑of‑use assets will be recognized when the production line is made available for use following completion of cGMP qualification.
Research tax credit
| Amount in millions of US dollars | |||||
Opening research tax credit receivable as of January 1, 2025 | |||||
‘+ Other operating income | |||||
- Payment received | ( | ||||
| - Adjustment and currency translation effect | |||||
Closing research tax credit receivable as of December 31, 2025 | |||||
Of which - Non-current portion | |||||
Of which - Current portion | |||||
| Amount in millions of US dollars | |||||
| Opening research tax credit receivable as of January 1, 2026 | |||||
| + Other operating income | |||||
| - Adjustment and currency translation effect | ( | ||||
Closing research tax credit receivable as of September 30, 2026 | |||||
| Of which - Non-current portion | |||||
| Of which - Current portion | |||||
In the fiscal year ended December 31, 2021, the Company recovered its Small & Medium Enterprise “SME” status under EU law, and became therefore eligible again for the immediate reimbursement of the Research Tax Credit. The Company received payment of the 2025 Research Tax Credit, of $5.6 million during the fourth quarter of 2026.
VAT Assets
Value-added tax (“VAT”) receivables primarily consisted of recoverable value-added taxes incurred on purchases and operating expenditures. The balance increased during the period, reflecting the receipt of VAT refunds from tax authorities related to previously submitted claims, partially offset by VAT generated from the Company’s ongoing operating, clinical development and commercial readiness activities.
Prepaid and deferred expenses & Other receivables
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Note 6 Lease contracts
Right of use Assets
| Real Estate | Other assets | Total | ||||||||||||||||||
| As of January 1, 2026 | — | — | ||||||||||||||||||
| New right of use assets | ||||||||||||||||||||
| Depreciation and amortization | ( | ( | ( | |||||||||||||||||
| Foreign exchange and other movements | ( | ( | ||||||||||||||||||
| As of September 30, 2026 | ||||||||||||||||||||
Operating leases' liabilities
Future minimum lease payments under the Company’s operating leases’ right of use as of September 30, 2026 and December 31, 2025 are as follows:
| September 30, 2026 | December 31, 2025 | ||||||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||||||
During the nine months ended September 30, 2026, the Company commenced a new operating lease for office facilities in Warren, New Jersey with an initial lease term of 45 months. Upon commencement, the Company recognized $1.9 0.6 million of landlord incentives, including tenant improvement allowances and rent credits, which reduced the initial carrying amount of the right-of-use asset.
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, | |||||||||||
| 2026 | 2025 | ||||||||||
Operating lease expense / (income) | |||||||||||
Note 7 Trade Payables and Other Current Liabilities
Trade Payables
| September 30, 2026 | December 31, 2025 | |||||||||||||
| Accounts payable | ||||||||||||||
| Accrued expenses | ||||||||||||||
| Total Trade Payables | ||||||||||||||
Trade payables increased from $40.9 million as of December 31, 2025 to $42.0 million as of September 30, 2026, reflecting higher activity (COMFORT Toddlers, the BLA and launch readiness), partly offset by the settlement of the PIPE transaction costs accrued at year-end 2025.
The following table summarizes the other liabilities as of September 30, 2026 and December 31, 2025:
| September 30, 2026 | December 31, 2025 | |||||||||||||
| Social debt | ||||||||||||||
| Tax liabilities | ||||||||||||||
| Other debts | ||||||||||||||
Total Other Current Liabilities | ||||||||||||||
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Note 8 Shareholders’ equity
The share capital as of September 30, 2026 is set at the sum of €31,438,880.70 ($36,064,786.19 converted at historical rates). It is divided into 314,388,807 fully authorized, subscribed and paid-up ordinary shares with a par value of €0.10 .
At the Annual General Meeting held on June 3, 2026 (the “General Meeting”), shareholders approved the allocation of the Company's accumulated deficit of $220,838,268 (€190,148,327 ) against additional paid-in capital (share premium).
The table below presents the changes in the share capital of the Company as of September 30, 2026 compared to December 31, 2025 at historical rate:
Amounts in millions of U.S. Dollars except share and per share data | Share capital in USD | Additional paid-in capital | Number of shares | |||||||||||
| Date | Nature of the transactions | |||||||||||||
| Total Equity Balance as of December 31, 2025 | ||||||||||||||
| 02/01/2026 | Capital increase by ordinary shares | |||||||||||||
| 02/01/2026 | Capital increase by ordinary shares | ( | ||||||||||||
| 06/01/2026 | Capital increase by ordinary shares | |||||||||||||
| 06/01/2026 | Capital increase by ordinary shares | |||||||||||||
| 09/01/2026 | Capital increase by employee RSU | |||||||||||||
| 14/01/2026 | Capital increase by ordinary shares | ( | ||||||||||||
| 16/01/2026 | Capital increase by employee RSU | |||||||||||||
| 22/01/2026 | Capital increase by ordinary shares | ( | ||||||||||||
| 22/01/2026 | Capital increase by ordinary shares | |||||||||||||
| 29/01/2026 | Capital increase by employee RSU | |||||||||||||
| 13/02/2026 | Capital increase by ordinary shares | ( | ||||||||||||
| 11/03/2026 | Capital increase by ordinary shares | ( | ||||||||||||
| 12/5/2026 | Capital increase by employee RSU | |||||||||||||
| 16/05/2026 | Capital increase by employee RSU | |||||||||||||
| 22/05/2026 | Capital increase by employee Stock Option | |||||||||||||
| 11/06/2026 | Retained earnings charged on share premium | ( | ||||||||||||
| 17/07/2026 | Capital increase by employee Stock Option | |||||||||||||
| 29/07/2026 | Capital increase by employee RSU | |||||||||||||
| 3/8/2026 | Capital increase by ordinary shares | |||||||||||||
| 26/08/2026 | Capital increase by employee Stock Option | |||||||||||||
Share-based payments | ||||||||||||||
| Net Issuance of warrants | ||||||||||||||
| Total Equity Balance as of September 30, 2026 | ||||||||||||||
Note 9 Fair Value Measurement
The Company reports assets and liabilities recorded at fair value on the Company’s condensed consolidated balance sheets based upon the level of judgment associated with inputs used to measure their fair value.
The fair value measurement level within the fair value hierarchy for a particular asset or liability is based on the lowest level of any input that is significant to the fair value measurement. Valuation techniques maximize the use of observable inputs and minimize the use of unobservable inputs.
Financial instruments not measured at fair value on the Company’s consolidated statement of financial position, but which require disclosure of their fair values include cash and cash equivalents, deposits, liquidity contract, accounts payable, and conditional advances. The fair values of these financial instruments are deemed to approximate their carrying amount.
There has been no transfer between levels of the fair value hierarchy and no change from the consolidated balance sheets ended December 31, 2025.
Derivative Instruments
The Company is exposed to increasing foreign exchange risk due to a portion of its procurement activities being conducted in the United States and invoiced in U.S. dollars, as well as through the activity of its subsidiary DBV Technologies Inc., in connection with the Company’s preparation for the potential launch of the VIASKIN Peanut patch in the United States, if approved.
This exposure has been increased by the continued depreciation of the U.S. dollar observed over the past year.
In this context, since 2025, the Company has hedged the current account of its US subsidiary through the use of financial instruments (foreign exchange swaps entered into with banking counterparties), which are linked to the subsidiary’s current account as of September 30, 2026.
14
The Company’s policy is not to enter into derivative transactions for speculative purposes.
| (In Million of dollars) | As of September 30, 2026 | As of December 31, 2025 | ||||||||||||||||||||||||||||||||||||
| Notional amount | Fair value | Due date | Notional amount | Fair value | Due date | |||||||||||||||||||||||||||||||||
| Asset | Liabilities | <1 year | Asset | Liabilities | <1 year | |||||||||||||||||||||||||||||||||
| Foreign exchange SWAP* Forward sale at maturity | Non-qualified derivative | |||||||||||||||||||||||||||||||||||||
*Forward sale at maturity
The Company's foreign currency swap arrangements do not qualify for hedge accounting. Accordingly, gains and losses arising from changes in fair value are recognized immediately within “Foreign exchange gains/(losses) (excluding operating activities)” in financial income (expense).
The fair value liability was nil for the nine months ended September 30, 2026, compared with a loss of $5 thousand for the year ended December 31, 2025.
Note 10 Share-Based Payments
The Board of Directors was authorized at the General Meeting to grant restricted stock units (“RSU”), stock options plan (“SO”), and non-employee warrants (Bons de Souscription d’Actions or “BSA”).
There were no changes during the period in the valuation methodologies, vesting terms or accounting policies applicable to the Company’s share-based awards from those disclosed in Note 11 to the consolidated financial statements included in the Annual Report.
During the nine months ended September 30, 2026, the Company granted two special performance-based stock unit awards to its Chief Executive Officer, representing an aggregate of up to 5,800,000 RSUs. The awards were granted in two tranches, consisting of 1,740,000 RSUs granted on May 5, 2026 and 4,060,000 RSUs granted on June 5, 2026. The RSUs are subject to a continued presence condition through July 1, 2028 and to performance conditions based on specified VIASKIN® Peanut regulatory milestones. The May 5, 2026 grant is linked to FDA acceptance for review of the applicable VIASKIN® Peanut BLA, with 870,000 RSUs allocated to children aged 4 to 7 years old and 870,000 RSUs allocated to the toddlers aged 1 to 3 years old, or 1,740,000 RSUs if a single BLA covering both age groups is accepted for review.
The June 5, 2026 grant is linked to FDA approval of VIASKIN® Peanut, with 2,900,000 RSUs allocated to the first FDA approval and 1,160,000 RSUs allocated to a second FDA approval, or 4,060,000 RSUs if a single BLA covering both age groups is approved. Vested shares are delivered in four installments through July 1, 2028. The Company recognizes compensation expense for these awards based on the grant-date fair value and its assessment of the probability of achieving the applicable performance conditions.
Changes in outstanding BSAs, stock options and RSUs during the period were as follows:
| Number of outstanding | |||||||||||||||||
| BSA | SO | RSUs | |||||||||||||||
| Balance as of December 31, 2025 | |||||||||||||||||
| Granted during the period | |||||||||||||||||
| Exercised/released during the period | ( | ( | |||||||||||||||
| Forfeited during the period | ( | ( | ( | ||||||||||||||
| Expired during the period | ( | ||||||||||||||||
| Balance as of September 30, 2026 | |||||||||||||||||
During the nine months ended September 30, 2026, the Company granted 1.1 million SOs and 6.5 million RSUs, including CEO special grants as described above.
As a result, outstanding RSUs and SOs increased to 10.0 million and 15.0 million, respectively, as of September 30, 2026, partially offset by 90,752 exercises or releases, 210,775 forfeitures, and 59,500 expirations during the period.
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, | ||||||||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||||||||||||||||
| Research & development | SO | ||||||||||||||||||||||||||||
| RSU | |||||||||||||||||||||||||||||
| Sales & marketing | SO | ||||||||||||||||||||||||||||
| RSU | |||||||||||||||||||||||||||||
| General & administrative | SO | ||||||||||||||||||||||||||||
| RSU | ( | ||||||||||||||||||||||||||||
15
Note 11 Contingencies & Employee Benefits
The following tables summarize contingencies as of September 30, 2026 and December 31, 2025:
| September 30, 2026 | December 31, 2025 | ||||||||||
| Current contingencies & Employee Benefits | |||||||||||
| Non-current contingencies & Employee Benefits | |||||||||||
| Total contingencies & Employee Benefits | |||||||||||
The changes in contingencies are as follows:
| Pension retirement obligations | Other contingencies | Total | |||||||||||||||
| At January 1, 2026 | |||||||||||||||||
| Increases in liabilities | |||||||||||||||||
| Actuarial gains and losses on defined-benefit plans | ( | — | ( | ||||||||||||||
| Currency translation effect | — | — | — | ||||||||||||||
| At September 30, 2026 | |||||||||||||||||
| Of which current | |||||||||||||||||
| Of which non-current | |||||||||||||||||
Note 12 Operating income
The following table summarizes the operating income during the three and nine months ended September 30, 2026 and 2025:
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||||||||||||||||||||||
| Research tax credit | |||||||||||||||||||||||||||||||||||
| Total | |||||||||||||||||||||||||||||||||||
Note 13 Allocation of Personnel Expenses
The Company had an average of 179 employees during the nine months ended September 30, 2026, compared to an average of 117 employees during the nine months ended September 30, 2025.
The following table summarizes the allocation of personnel expenses by function during the nine months ended September 30, 2026 and 2025:
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||||||||||
| Research and Development expenses | |||||||||||||||||||||||
| Sales & Marketing expenses | |||||||||||||||||||||||
| General & Administrative expenses | |||||||||||||||||||||||
| Total personnel expenses | |||||||||||||||||||||||
The following table summarizes the allocation of personnel expenses by nature during the nine months ended September 30, 2026 and 2025:
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||||||||||
| Wages and salaries | |||||||||||||||||||||||
| Social security contributions | |||||||||||||||||||||||
| Expenses for pension commitments | |||||||||||||||||||||||
| Share-based payments | |||||||||||||||||||||||
| Total | |||||||||||||||||||||||
16
Personnel expenses for the period ended September 30, 2026, increased by $23.7 million compared to the nine months ended September 30, 2025 and by $9.3 million compared to the three months ended September 30, 2025.
The increase in personnel expenses reflected the Company's continued investment in advancing VIASKIN® Peanut toward potential commercialization. Additional financing completed during 2026 enabled further organizational expansion and commercial readiness, including third-quarter interactions with the FDA, the submission of the BLA for VIASKIN® Peanut in children ages 4 through 7 on September 29, 2026, and preparation for a potential commercial launch, if approved.
Note 14 Commitments
In the ordinary course of business, the Company enters into agreements with Contract Research Organizations ("CROs"), Contract Manufacturing Organizations ("CMOs") and strategic manufacturing partners. Certain arrangements include non-cancellable purchase commitments and minimum purchase obligations extending beyond the current reporting period. These commitments are generally not recognized in the consolidated balance sheet until the related goods or services are received, unless recognition of a liability is required under applicable U.S. GAAP, including when a loss contingency is probable and reasonably estimable.
The following table presents our material expenses commitments for future periods:
| 2026 | 2027 | 2028 | Thereafter | Total | |||||||||||||
(Amounts in USD million) | |||||||||||||||||
Clinical development commitments (CRO agreements) | |||||||||||||||||
Manufacturing and supply commitments (CMO agreements) | |||||||||||||||||
| Total contractual commitments | |||||||||||||||||
Clinical development commitments primarily represent remaining contractual obligations under agreements with contract research organizations and other service providers supporting the Company’s clinical programs, including amounts committed under executed change orders.
Manufacturing and supply commitments primarily represent obligations under the Company’s strategic manufacturing arrangements with Sanofi and Fareva supporting clinical, regulatory and potential commercial supply of VIASKIN® Peanut. These commitments include the Company’s arrangements with Fareva Amboise related to manufacturing readiness and dedicated production capacity, including the Letter of Intent, as amended, and the amendment to the Services Agreement covering additional production batches. They also include the PDS Services Agreement and related Binding Commercial Term Sheet with Fareva La Vallée for the establishment of dedicated PDS manufacturing capabilities and associated transfer services, as well as the Company’s other contractual manufacturing and supply obligations with Sanofi and Fareva.
Letter of Credit and Collateral
A Certificate of Deposit, for an initial amount of $0.3 million was signed in order to guarantee an American Express credit cards program in the United States.
Note 15 Relationships with Related Parties
During the nine months ended September 30, 2026, the Company identified two significant related-party transactions.
•The first transaction relates to the $5.0 million capital contribution made by DBV Technologies S.A. to its wholly-owned subsidiary, DBV Technologies Inc. The contribution was made to support the subsidiary's operating activities and was accounted for as an equity contribution between entities under common control. As a result, the transaction had no impact on the Company's consolidated financial statements.
•The second transaction relates to special performance-based restricted stock unit awards granted to the Company's Chief Executive Officer. The award is subject to both continued service and specified performance conditions tied to regulatory milestones associated with VIASKIN® Peanut. The award was approved by the Board of Directors upon recommendation of the Compensation Committee and is accounted for as a share-based payment arrangement. Additional information regarding the award is included in Note 10 - Share-Based Payments.
Other than the transactions described above, there were no material changes in the nature of the related-party transactions disclosed in Note 17 to the consolidated financial statements included in the Annual Report.
The compensation amounts presented below, which were awarded to the Directors and Officers of the Company totaled $13.2 million.
| Nine Months Ended September 30, | |||||||||||
| 2026 | 2025 | ||||||||||
Short-term benefits | |||||||||||
| Post-employment benefits | |||||||||||
Share-based payments | |||||||||||
| Total | |||||||||||
Share-based payments to directors and officers are described in Note 10 Share-Based Payments. The valuation methods are described in Note 11 to the consolidated financial statements included in the Annual Report.
Amounts payable to related parties as of September 30, 2026 and December 31, 2025 are as follows:
17
| September 30, 2026 | December 31, 2025 | ||||||||||
Compensation | |||||||||||
Pension obligations | |||||||||||
| Total | |||||||||||
The parent company, DBV Technologies S.A., entered into a cash‑pooling agreement with its subsidiaries (DBV Technologies Inc., DBV Technologies Australia Pty Ltd and DBV Pharma SAS), the balance of which amounts to the following:
| September 30, 2026 | December 31, 2025 | ||||||||||
Loans & Advances | |||||||||||
| Total | |||||||||||
Note 16 Loss Per Share
The basic loss per share is calculated by dividing net loss attributable to the Company’s shareholders by the weighted‑average number of ordinary shares outstanding during the period. Following the March 2025 PIPE Financing, this weighted‑average share count includes the shares underlying the pre‑funded warrants, as the remaining cash exercise price for those warrants is considered immaterial.
The computations for basic and diluted loss per share were as follows (in millions of U.S. Dollars except share and per share data):
| Nine Months Ended September 30, | |||||||||||
| 2026 | 2025 | ||||||||||
| Net loss in Million of USD | ( | ( | |||||||||
| Weighted average number of ordinary shares | |||||||||||
| Net loss per share attributable to ordinary shareholders, basic and diluted ($/share) | ( | ( | |||||||||
| September 30, 2026 | December 31, 2025 | ||||||||||||||||
| Warrants | Shares * | Warrants | Shares * | ||||||||||||||
| Non-employee warrants | |||||||||||||||||
| Stock-options | |||||||||||||||||
| Restricted stock units | |||||||||||||||||
| Prefunded warrants | |||||||||||||||||
| PFW 2022 | |||||||||||||||||
| BSA from ABSA (March 2025 PIPE Financing) | |||||||||||||||||
| PFW1 from PFW-BS-PFW (March 2025 PIPE Financing) | |||||||||||||||||
| BS from PFW-BS-PFW (March 2025 PIPE Financing) | |||||||||||||||||
| PFW2 (March 2025 PIPE Financing) | |||||||||||||||||
Total Shares | |||||||||||||||||
Note 17 Reportable segment disclosure
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||||||
| Clinical studies | ||||||||||||||||||||
| BLA & Regulatory | ||||||||||||||||||||
| Medical Affairs & Other Medical | ||||||||||||||||||||
| Research & Innovation | ||||||||||||||||||||
| Manufacturing & Supply and Quality | ||||||||||||||||||||
| Sales & Marketing | ||||||||||||||||||||
| General & Administrative | ||||||||||||||||||||
| Total expenses | ||||||||||||||||||||
18
The Company operates and is managed as one
The Company’s Chief Executive Officer as the chief operating decision maker (“CODM”) manages and allocates resources to the operations of the total company by assessing the overall level of resources available and how to best allocate them to support the Company’s long-term company-wide strategic goals. In making this decision, the CODM uses consolidated financial information for the purposes of evaluating performance, allocating resources, setting incentive compensation targets and planning and forecasting for future periods.
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.
Note 18 Events after the Close of the Period
The Company evaluated subsequent events through the date of issuance of the unaudited condensed consolidated financial statements and identified no subsequent events requiring recognition or disclosure.
19
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, 2025, included in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 26, 2026, as amended by the Amendment No. 1 on Form 10-K/A filed with the SEC on April 30, 2026, 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 late-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, our proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin, an epicutaneous patch (i.e., a skin patch). We have generated significant data demonstrating that Viaskin’s mechanism of action is novel and differentiated. Viaskin targets specialized antigen-presenting immune cells in the skin, called Langerhans cells, that capture the antigen that accumulates in the outer layer of the skin, and then migrate to the skin-draining lymph nodes in order to activate the immune system without passage of the antigen into the bloodstream, minimizing systemic exposure in the body. We are advancing this unique technology to treat children suffering from food allergies, for whom safety is paramount, since the introduction of the offending allergen into their bloodstream can cause severe or life-threatening allergic reactions, such as anaphylactic shock. We believe Viaskin may offer convenient, self-administered, non-invasive immunotherapy to patients, if approved.
Our most advanced product candidate is Viaskin Peanut patch, evaluated as a potential immunotherapy for children with peanut allergy in twelve clinical trials, including four Phase 2 trials and five completed Phase 3 trials. We are advancing two separate Viaskin Peanut product candidates in parallel to support two potential BLAs in two distinct age groups: one in toddlers ages one through three with the original, or square, patch, and one in children ages four through seven with the modified, or circular, patch. We submitted the BLA for Viaskin Peanut patch as a potential treatment for children 4 through 7 years old in the third quarter of 2026 and requested Priority Review. We also have an ongoing Phase 3 supplementary safety study of Viaskin Peanut patch in peanut-allergic toddlers ages one through three. We have held discussions with the FDA on how to ensure a timely review of the BLA for Viaksin Peanut for toddlers aged 1 through 3 years following the recent submission of the BLA for Viaskin Peanut for children 4 through 7 years old, including a potential rolling submission of the 1-through-3 BLA. The same review team will review both BLAs. The FDA indicated to us that a review of the BLA for Viaskin Peanut for 1 through 3 year olds initiated shortly after the review of the 4-through-7 BLA would allow the FDA to build on the learnings from its review and the efficiencies expected from the meaningful content overlap of the two BLAs. It would provide us and FDA the opportunity to align on the form, content, and best timing of the components of the submission of the BLA for Viaskin Peanut for 1 through 3 year olds, in support of an efficient review of both BLAs. We will continue the regulatory dialogue with FDA over the next few months and expect to submit the BLA for Viaskin Peanut in toddlers 1 through 3 years old in 2027, and we expect to will provide further update once the regulatory pathway for our toddler program has been finalized.
The Company has earlier-stage food allergy programs including Viaskin Milk and other autoimmune inflammatory diseases.
Recent developments
During the third quarter of 2026, we made significant progress toward the potential commercialization of VIASKIN® Peanut. Following extensive interactions with the FDA during the quarter, we submitted our BLA for VIASKIN Peanut in children ages 4 through 7 years old on September 29, 2026 and requested Priority Review.
In parallel, supported by our strengthened financial resources extended through the refresh of the ATM Program, we accelerated the build-out of our commercial capabilities and continued to advance clinical development, manufacturing and supply-chain readiness and institutional investor engagement, including preparations for FDA inspection, while progressing launch infrastructure.
We are actively working to advance launch infrastructure, including distribution and patient access capabilities to support the launch of VIASKIN Peanut patch in the United States, upon approval..
Regulatory Development
Submission of BLA FDA for the VIASKIN® Peanut Patch in Children Aged 4-7 Years
On June 29, 2026, we announced that we had ongoing detailed iterative engagement with FDA with the goal of ensuring a complete, efficient, and timely review of tour BLA for children aged 4 through 7 years, and, through this process and based on FDA review, we received valuable, actionable input from the FDA, specific to the organization, mapping, and formatting of existing data sets for the CMC and biostatistical elements of the BLA. We announced further that we would take the required time to incorporate the FDA’s feedback and that it anticipated the BLA filing to occur in the third quarter of 2026. The FDA did not request any additional data.
On June 29, 2026, we announced that we had ongoing detailed iterative engagement with FDA with the goal of ensuring a complete, efficient, and timely review of tour BLA for children aged 4 through 7 years, and, through this process and based on FDA review, we received valuable, actionable input from the FDA, specific to the organization, mapping, and formatting of existing data sets for the CMC and biostatistical elements of the BLA. We announced further that we would take the required time to incorporate the FDA’s feedback and that it anticipated the BLA filing to occur in the third quarter of 2026. The FDA did not request any additional data.
On September 29, 2026, we announced the submission of a BLA to FDA seeking approval of the VIASKIN Peanut patch for the treatment of peanut allergy in children aged 4 through 7 years. The submission is supported by data from the Phase 3 VITESSE study, a randomized, double-blind, placebo-controlled trial, which enrolled 654 children. We requested Priority Review, which, if granted, would reduce the standard review period from ten to six months. The FDA has 60 days from the submission date to determine whether the BLA is sufficiently complete to permit substantive review, following which we anticipate receipt of a PDUFA target action date. The BLA filing represents a significant regulatory milestone and an important step toward the potential commercialization of VIASKIN® Peanut in the United States. There can be no assurance that the FDA will accept the BLA for filing, grant Priority Review, or ultimately approve the VIASKIN® Peanut patch.
20
Clinical Development Update
Phase 2 THRIVE Study
On June 2, 2026, we announced that the first participant had been screened in the Phase 2 THRIVE study evaluating the efficacy and safety of the VIASKIN® Peanut patch in infants aged 6 through 12 months with peanut allergy. The study has since progressed to eight participating clinical sites and eight enrolled patients. THRIVE is a single-arm, open-label study designed to assess the ability of participants to achieve ad lib consumption of dietary peanut following 36 months of treatment with the VIASKIN® Peanut patch. We believe the THRIVE study may provide additional information regarding the potential use of the VIASKIN® Peanut patch in younger patient populations.
Financing
Shelf Registration Statement, ATM Program Refresh and Sale of $50 million in gross proceeds under ATM Program
On July 27, 2026, we filed an automatically effective shelf registration statement on Form S-3ASR with the SEC. The shelf registration statement permits us to sell, from time to time, ADSs representing ordinary shares and warrants. At the time of filing the shelf registration statement, we also filed a prospectus supplement with the SEC authorizing the sale of up to $150.0 million of ADSs under our existing ATM Program. On August 3, 2026, we announced the sale of $50.0 million in gross proceeds of ADSs to RA Capital Management, L.P. under the ATM Program. In connection with this transaction, we issued 18,288,220 new ordinary shares, underlying 3,657,644 new ADSs, at an at-the-market price of $13.67 per ADS.
On July 27, 2026, we filed an automatically effective shelf registration statement on Form S-3ASR with the SEC. The shelf registration statement permits us to sell, from time to time, ADSs representing ordinary shares and warrants. At the time of filing the shelf registration statement, we also filed a prospectus supplement with the SEC authorizing the sale of up to $150.0 million of ADSs under our existing ATM Program. On August 3, 2026, we announced the sale of $50.0 million in gross proceeds of ADSs to RA Capital Management, L.P. under the ATM Program. In connection with this transaction, we issued 18,288,220 new ordinary shares, underlying 3,657,644 new ADSs, at an at-the-market price of $13.67 per ADS.
March 2025 PIPE Financing
We received the supplemental gross proceeds of $94.7 million (€81 million) resulting in the full exercise of the ABSA Warrants and BS Warrants issued on our March 2025 PIPE Financing. See “Note 2: Significant Events and Transactions - March 2025 PIPE Financing” in the notes to the condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information.
We received the supplemental gross proceeds of $94.7 million (€81 million) resulting in the full exercise of the ABSA Warrants and BS Warrants issued on our March 2025 PIPE Financing. See “Note 2: Significant Events and Transactions - March 2025 PIPE Financing” in the notes to the condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information.
Manufacturing and supply-chain readiness
Amendment to the Letter of intent signed with Fareva Amboise
On September 30, 2026, the Company entered into Amendment No. 1 to its June 25, 2026 Letter of Intent with Fareva Amboise concerning manufacturing readiness activities supporting the future commercial-scale manufacture of the VIASKIN® Peanut patch. The planned investment is estimated at $5.5 million (at the exchange rate of 1€ = $1.14). Under the amendment, the Company's $1.1 million (at the exchange rate of 1€ = $1.14) upfront contribution to this project was modified such that payment is no longer contingent upon FDA approval of the Company's Biologics License Application. Instead, payment is contingent upon the successful completion of an independent Mock Pre-Approval Inspection , including the absence of critical findings or repeat observations and remediation of all findings by February 1, 2027.
On September 30, 2026, the Company entered into Amendment No. 1 to its June 25, 2026 Letter of Intent with Fareva Amboise concerning manufacturing readiness activities supporting the future commercial-scale manufacture of the VIASKIN® Peanut patch. The planned investment is estimated at $5.5 million (at the exchange rate of 1€ = $1.14). Under the amendment, the Company's $1.1 million (at the exchange rate of 1€ = $1.14) upfront contribution to this project was modified such that payment is no longer contingent upon FDA approval of the Company's Biologics License Application. Instead, payment is contingent upon the successful completion of an independent Mock Pre-Approval Inspection , including the absence of critical findings or repeat observations and remediation of all findings by February 1, 2027.
In addition, the amendment finalized and secured the workforce expansion component of the project, including training and extended readiness activities. These personnel are dedicated to supporting industrial ramp-up, execution of the remediation plan and commercial manufacturing preparedness. The parties continue to negotiate a definitive commercial manufacturing and supply agreement. The Company expects the amended arrangement to support the timely execution of manufacturing readiness activities and further prepares the Amboise facility for future commercial production of VIASKIN® Peanut, if approved, including activities necessary to support a successful FDA pre-approval inspection.
Services Agreement with Fareva La Vallée - Peanut Drug Substance
On July 8, 2026, the Company entered into a PDS Services Agreement and Binding Commercial Term Sheet with FLV relating to the construction development, installation and qualification of a dedicated PDS manufacturing line, as well as related transfer services for technical and validation batches. The PDS facility services are expected to be completed no later than September 30, 2027, and the transfer services no later than September 1, 2028. The agreement also includes binding commercial terms expected to be incorporated into a future definitive manufacturing and supply agreement.
On July 8, 2026, the Company entered into a PDS Services Agreement and Binding Commercial Term Sheet with FLV relating to the construction development, installation and qualification of a dedicated PDS manufacturing line, as well as related transfer services for technical and validation batches. The PDS facility services are expected to be completed no later than September 30, 2027, and the transfer services no later than September 1, 2028. The agreement also includes binding commercial terms expected to be incorporated into a future definitive manufacturing and supply agreement.
Letter of intent signed with Integrated Commercialization Solutions
On June 5, 2026, the Company entered into a Letter of Intent with Integrated Commercialization Solutions, LLC ("ICS") in connection with future commercialization support and distribution services for the VIASKIN® Peanut patch in the United States, if approved. Under the letter of intent, the parties agreed to undertake certain preliminary launch readiness and implementation planning activities while continuing negotiations toward a definitive commercial outsourcing services agreement. The contemplated activities include operational planning, systems readiness, distribution infrastructure preparation and other commercialization support services intended to facilitate a potential future product launch, if approved. Management expects execution of the definitive agreement by the end of 2026.
On June 5, 2026, the Company entered into a Letter of Intent with Integrated Commercialization Solutions, LLC ("ICS") in connection with future commercialization support and distribution services for the VIASKIN® Peanut patch in the United States, if approved. Under the letter of intent, the parties agreed to undertake certain preliminary launch readiness and implementation planning activities while continuing negotiations toward a definitive commercial outsourcing services agreement. The contemplated activities include operational planning, systems readiness, distribution infrastructure preparation and other commercialization support services intended to facilitate a potential future product launch, if approved. Management expects execution of the definitive agreement by the end of 2026.
Manufacturing Supply Agreement (Peanut Source Material) with Fareva La Vallée
On March 17, 2026, the Company entered into the MS Agreement with FLV, under which FLV will manufacture and supply the PSM exclusively for DBV Technologies S.A. during the agreement term. The term is effective for a period of eight (8) years and can be renewed for a period of two (2) years.
On March 17, 2026, the Company entered into the MS Agreement with FLV, under which FLV will manufacture and supply the PSM exclusively for DBV Technologies S.A. during the agreement term. The term is effective for a period of eight (8) years and can be renewed for a period of two (2) years.
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.
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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.
Business Trends and Results of Operations
Comparison of the Three Months Ended September 30, 2026 and 2025
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 millions of U.S. dollars, for the three months ended September 30, 2026 and 2025.
| Three Months Ended September 30, | |||||||||||||||||||||||
| 2026 | 2025 | $ change | % of change | ||||||||||||||||||||
Operating income | 1.6 | 2.8 | (1.2) | (44)% | |||||||||||||||||||
Operating expenses | |||||||||||||||||||||||
| Research and development expenses | (47.0) | (28.6) | (18.4) | 64% | |||||||||||||||||||
| Sales and marketing expenses | (5.3) | (1.2) | (4.2) | 354% | |||||||||||||||||||
| General and administrative expenses | (14.0) | (7.3) | (6.7) | 93% | |||||||||||||||||||
| Total Operating expenses | (66.3) | (37.1) | (29.3) | 79% | |||||||||||||||||||
Financial income (expense) | 0.6 | 1.1 | (0.5) | (47)% | |||||||||||||||||||
Income tax | (0.3) | — | (0.3) | —% | |||||||||||||||||||
Net loss | (64.5) | (33.2) | (31.3) | 94% | |||||||||||||||||||
The following table summarizes our operating income during the three months ended September 30, 2026 and 2025:
| Three Months Ended September 30, | |||||||||||||||||||||||
| 2026 | 2025 | $ change | % of change | ||||||||||||||||||||
Sales | |||||||||||||||||||||||
Other income | 1.6 | 2.8 | (1.2) | (43)% | |||||||||||||||||||
| Research tax credit | 1.6 | 2.8 | (1.2) | (43)% | |||||||||||||||||||
| Other operating income | |||||||||||||||||||||||
Total operating income | 1.6 | 2.8 | (1.2) | (43)% | |||||||||||||||||||
The Company did not generate Revenue from operating activities.
Research tax credit decreased by $1.2 million for the three months ended September 30, 2026, compared to the three months ended September 30,2025. The accrual reflects the lower level of eligible research activities, as the Company’s focus continues to shift from clinical development toward commercial readiness activities.
Operating Expenses
Research and Development Expenses
The following table summarizes our research and development expenses incurred during the three months ended September 30, 2026 and 2025:
| Research and Development expenses | Three Months Ended September 30, | ||||||||||||||||||||||
| 2026 | 2025 | $ change | % of change | ||||||||||||||||||||
External clinical-related expenses | 26.2 | 18.0 | 8.2 | 45% | |||||||||||||||||||
Employee-related costs | 7.2 | 4.8 | 2.4 | 49% | |||||||||||||||||||
Share-based payment expenses | 1.2 | 0.4 | 0.8 | 184% | |||||||||||||||||||
BLA fees and other costs | 7.9 | 1.7 | 6.2 | 371% | |||||||||||||||||||
Pre-Commercial Inventory | 4.5 | 3.7 | 0.9 | 24% | |||||||||||||||||||
| Total Research and Development expenses | 47.0 | 28.6 | 18.4 | 64% | |||||||||||||||||||
External clinical-related expenses increased by $8.2 million for the three months ended September 30, 2026, compared to the three months ended September 30, 2025. The increase was primarily driven by accelerated patient enrollment in COMFORT Toddlers study, with the last patient randomized in August 2026, the ramp-up of expenses associated to THRIVE study, initiated in 2026, and the acceleration of BLA readiness activities to prepare BLA submission. This increase was partially offset by the completion of EPOPEX study and the resulting reduction in associated expenses, as well as lower costs related to VITESSE study after the last patient last visit double-blind placebo-controlled end of 2025.
Employee-related costs and share based payment expenses respectively increased by $2.4 million and $0.8 million for the three months ended September 30, 2026, compared to the three months ended September 30, 2025. This increase is consistent with the reinforcement of Medical Affairs, Quality and
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Regulatory functions in the United States, representing 38 new hirings across these functions compared to September 30, 2025, to support a potential U.S. launch, if approved, and to ensure organizational readiness as the Company approaches commercialization.
Following extensive interactions with the FDA, the Company also submitted its BLA for children ages 4 through 7 on September 29, 2026 and requested Priority Review, resulting in the recognition of $4.7 million of previously deferred BLA-related costs, which accounted for the majority of $7.9 million recognized during the period.
Pre-commercial inventory expense increased by $0.9 million, or 24%, reflecting the continued build-up of potential commercial inventory as the Company advances launch readiness for VIASKIN® Peanut. Following the manufacturing ramp-up initiated in the third quarter of 2025, the Company continued to receive inventory produced essentially by its contract manufacturing organizations, to support potential commercial launch requirements. Until BLA approval is obtained, the related manufacturing costs continue to be recognized as research and development expense.
Sales and Marketing Expenses
The following table summarizes our sales and marketing expenses incurred during the three months ended September 30, 2026 and 2025:
| Sales & Marketing expenses | Three Months Ended September 30, | ||||||||||||||||||||||
| 2026 | 2025 | $ change | % of change | ||||||||||||||||||||
External professional services | 3.1 | 0.5 | 2.6 | 520% | |||||||||||||||||||
Employee-related costs | 1.7 | 0.2 | 1.5 | 688% | |||||||||||||||||||
Share-based payment expenses | 0.4 | — | 0.4 | 2046% | |||||||||||||||||||
Depreciation, amortization and other costs | 0.2 | 0.4 | (0.2) | (56)% | |||||||||||||||||||
| Total Sales & Marketing expenses | 5.3 | 1.2 | 4.2 | 353% | |||||||||||||||||||
For the fourth consecutive quarter, sales and marketing expenses have increased, rising by $4.2 million during the three months ended September 30, 2026, compared to the three months ended September 30, 2025. This reflects the continued execution of the Company’s commercial launch readiness strategy in the United States. The increase was primarily driven by higher personnel-related and external costs associated with the expansion of the Company’s commercial, market access and launch-support capabilities in preparation for the potential U.S. launch of VIASKIN® Peanut, if approved. This expansion included the hiring of 15 U.S.-based employees compared to September 30, 2025, across Market Access and Patient Services (5), Marketing and Market Insights (4), Sales and Commercial Operations (3), and Commercial Leadership and Transformation (3).
General and Administrative Expenses
The following table summarizes our general and administrative expenses incurred during the three months ended September 30, 2026 and 2025:
| General & Administrative expenses | Three Months Ended September 30, | ||||||||||||||||||||||
| 2026 | 2025 | $ change | % of change | ||||||||||||||||||||
External professional services | 4.0 | 2.8 | 1.2 | 44% | |||||||||||||||||||
Employee-related costs | 3.2 | 2.2 | 1.0 | 45% | |||||||||||||||||||
Share-based payment expenses | 3.4 | 0.1 | 3.3 | 4002% | |||||||||||||||||||
Depreciation, amortization and other costs | 3.4 | 2.2 | 1.2 | 55% | |||||||||||||||||||
| Total General & Administrative expenses | 14.0 | 7.3 | 6.7 | 93% | |||||||||||||||||||
General and Administrative expenses increased by $6.7 million for the three months ended September 30, 2026, compared to the three months ended September 30, 2025, reflecting continued scaling of the Company’s corporate infrastructure to support BLA readiness and commercial launch preparedness. The increase was driven by $3.3 million of higher share-based compensation expense, related to new CEO grants, together with higher employee-related costs associated with 11 additional employees compared to September 30, 2025.
Other operating expenses also increased mainly driven by the extension of the New Jersey office lease, D&O insurance as well as patents and licenses expenses.
Financial Income (Expense)
Our financial income was $0.6 million for the three months ended September 30, 2026, compared to $1.1 million for the three months ended September 30, 2025, reflecting interest income generated from the investment of available cash.
Income Tax
Our income tax expense was $0.3 million for the three months ended September 30, 2026 and was 0 for the three months ended September 30, 2025.
Net Loss
Net loss was $64.5 million for the three months ended September 30, 2026, compared to $33.2 million for the three months ended September 30, 2025. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.14 and $0.24 for the three months ended September 30, 2026 and 2025, respectively.
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Comparison of the Nine Months Ended September 30, 2026 and 2025
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 millions of U.S. dollars, for the nine months ended September 30, 2026 and 2025.
| Nine Months Ended September 30, | |||||||||||||||||||||||
| 2026 | 2025 | $ change | % of change | ||||||||||||||||||||
| Operating income | 3.1 | 5.0 | (1.8) | (37)% | |||||||||||||||||||
| Operating expenses | |||||||||||||||||||||||
| Research and development expenses | (111.6) | (83.8) | (27.8) | 33% | |||||||||||||||||||
| Sales and marketing expenses | (15.7) | (1.9) | (13.9) | 747% | |||||||||||||||||||
| General and administrative expenses | (39.1) | (21.3) | (17.7) | 83% | |||||||||||||||||||
| Total Operating expenses | (166.4) | (107.0) | (59.4) | 56% | |||||||||||||||||||
| Financial income (expense) | 1.5 | — | 1.5 | n.m | |||||||||||||||||||
| Income tax | (0.7) | (0.1) | (0.6) | 521% | |||||||||||||||||||
| Net loss | (162.5) | (102.1) | (60.4) | 59% | |||||||||||||||||||
Operating Income
The following table summarizes our operating income during the nine months ended September 30, 2026 and 2025:
| Nine Months Ended September 30, | |||||||||||||||||||||||
| 2026 | 2025 | $ change | % of change | ||||||||||||||||||||
| Research tax credit | 3.1 | 5.0 | (1.8) | (37)% | |||||||||||||||||||
Total Other operating income | 3.1 | 5.0 | (1.8) | (37)% | |||||||||||||||||||
The Company did not generate Revenue from operating activities.
This caption consists of Research Tax Credit (crédit d’impôt recherche, or CIR) that is granted to companies by the French tax authorities in order to encourage them to conduct technical and scientific researches. The Company accrued $3.1 million as of September 30, 2026. This tax credit income accrual reflects the expected level, on a full year basis of eligible experimental activities, as the Company’s focus continues to shift from clinical development toward commercial readiness activities.
Operating Expenses
Research and Development Expenses
The following table summarizes our research and development expenses incurred during the nine months ended September 30, 2026 and 2025:
| Nine Months Ended September 30, | |||||||||||||||||||||||
| 2026 | 2025 | $ change | % of change | ||||||||||||||||||||
| External clinical-related expenses | 62.9 | 47.3 | 15.6 | 33% | |||||||||||||||||||
| Employee-related costs | 22.7 | 14.0 | 8.7 | 62% | |||||||||||||||||||
| Share-based payment expenses | 3.5 | 1.5 | 2.0 | 130% | |||||||||||||||||||
| BLA fees and other costs | 12.3 | 7.1 | 5.3 | 74% | |||||||||||||||||||
| Pre-Commercial Inventory | 10.2 | 13.9 | (3.7) | (27)% | |||||||||||||||||||
| Total Research and Development expenses | 111.6 | 83.8 | 27.8 | 33% | |||||||||||||||||||
External clinical-related expenses increased by $15.6 million for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025. The increase primarily reflects higher clinical trial activity during the first nine month of 2026, mainly driven by accelerated patient enrollment in COMFORT Toddlers study, with the last patient randomized in August 2026, the ramp-up of expenses associated to THRIVE study, initiated in 2026, as well as the acceleration of BLA readiness activities to prepare BLA submission. This increase was partially offset by the completion of EPOPEX study and the resulting reduction in associated expenses, as well as lower costs related to VITESSE study after the last patient last visit double-blind placebo-controlled end of 2025.
Employee-related costs and share based payment expenses respectively increased by $8.7 million and $2.0 million for the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025 primarily due to reinforcement of Medical Affairs, Quality and Regulatory functions in the United States, representing 38 new hirings across these functions compared to September 30, 2025, to support a potential U.S. launch, if approved, and to ensure organizational readiness as the Company approaches commercialization.
Following extensive interactions with the FDA, the Company also submitted its BLA for children ages 4 through 7 on September 29, 2026 and requested Priority Review, resulting in the recognition of $4.7 million of previously deferred BLA-related costs, which accounted for the majority of the increase of $5.3 million compared to September 30, 2025.
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Pre-commercial inventory expense decreased by $3.7 million, reflecting the significant manufacturing ramp-up undertaken in 2025 following the March 2025 PIPE financing and alignment with the FDA. During 2026, the Company maintained a more established production cadence while continuing to build potential commercial inventory and advance launch readiness for VIASKIN® Peanut. These costs continue to be recognized as research and development expense prior to BLA approval.
Sales and Marketing Expenses
The following table summarizes our sales and marketing expenses incurred during the nine months ended September 30, 2026 and 2025:
| Nine Months Ended September 30, | |||||||||||||||||||||||
| 2026 | 2025 | $ change | % of change | ||||||||||||||||||||
| External professional services | 10.0 | 0.8 | 9.3 | 1226% | |||||||||||||||||||
| Employee-related costs | 4.5 | 0.5 | 3.9 | 748% | |||||||||||||||||||
| Share-based payment expenses | 0.8 | 0.1 | 0.7 | 1345% | |||||||||||||||||||
| Depreciation, amortization and other costs | 0.5 | 0.5 | (0.1) | (12)% | |||||||||||||||||||
| Total Sales & Marketing expenses | 15.7 | 1.9 | 13.9 | 747% | |||||||||||||||||||
Sales and marketing expenses increased by $13.9 million during the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025. The increase was primarily driven by higher personnel-related and external costs associated with the expansion of the Company’s commercial, market access and launch-support capabilities in preparation for the potential U.S. launch of VIASKIN® Peanut, if approved. This expansion included the hiring of 15 U.S.-based employees compared to September 30, 2025, across Market Access and Patient Services (5), Marketing and Market Insights (4), Sales and Commercial Operations (3), and Commercial Leadership and Transformation (3).
General and Administrative Expenses
The following table summarizes our general and administrative expenses incurred during the nine months ended September 30, 2026 and 2025:
| General & Administrative expenses | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2026 | 2025 | $ change | % of change | ||||||||||||||||||||
| External professional services | 10.8 | 6.4 | 4.5 | 70% | |||||||||||||||||||
| Employee-related costs | 11.0 | 7.4 | 3.7 | 50% | |||||||||||||||||||
| Share-based payment expenses | 6.6 | 1.9 | 4.7 | 252% | |||||||||||||||||||
| Depreciation, amortization and other costs | 10.6 | 5.8 | 4.9 | 85% | |||||||||||||||||||
| Total General & Administrative expenses | 39.1 | 21.3 | 17.7 | 83% | |||||||||||||||||||
General and Administrative expenses increased by $17.7 million for the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025, reflecting continued investments in corporate infrastructure to support BLA readiness and potential commercial launch preparations.
The increase was mainly driven by $3.7 million in employee-related costs and $4.7 million in share-based payment expenses, attributable to 11 additional employees and new CEO grants. Depreciation, amortization and other costs also rose by $4.9 million primarily due to the extension of the New Jersey office lease, D&O insurance, Director fees, and patents and licenses expenses.
Financial Income (Expense)
Our financial income was $1.5 million for the nine months ended September 30, 2026, compared to nil for the nine months ended September 30, 2025. The increase primarily reflects higher interest income earned on larger average cash and investment balances following financing activities. Financial income for the 2025 comparative period was totally offset by unfavorable foreign exchange effects, which reduced the benefit of interest income earned on investments.
Income Tax
Our income tax expense was $0.7 million for the nine months ended September 30, 2026 compared to $0.1 million for the nine months ended September 30, 2025.
Net Loss
Net loss was $162.5 million for the nine months ended September 30, 2026, compared to $102.1 million for the nine months ended September 30, 2025. Net loss per share (based on the weighted average number of shares outstanding over the period) decreased from $(0.82) to $(0.37) for the nine months ended September 30, 2025 and September 30, 2026, respectively.
Liquidity and Capital Resources
Our financing strategy is to maintain financial flexibility to support regulatory and potential commercial launch activities, including working capital requirements, pre-commercial inventory build and manufacturing capacity expansion to support potential demand for VIASKIN Peanut in the United States and Europe, if approved.
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Financial Condition
On September 30, 2026, the Company held $165.7 million in cash and cash equivalents compared to $194.2 million of cash and cash equivalents held on December 31, 2025. Net cash used in operating & investing activities totaled $159.4 million and $86.7 million for the periods ended September 30, 2026 and September 30, 2025, respectively. Net cash provided by financing activities totaled $137.1 million for the periods ended September 30, 2026 and $117.1 million in September 30, 2025, reflecting net proceeds from the first and second tranches of the March 2025 PIPE Financing and drawdowns under the Company's at-the-market equity program.
In addition, the Company's results of operations and financial position are subject to the effects of foreign currency fluctuations, principally between the U.S. dollar and the Euro. The Company's functional currency is the Euro, while its reporting currency is the U.S. dollar. The Company incurs operating expenses in both currencies: a significant portion of external costs, including those related to commercial activities, regulatory affairs, and clinical development, are denominated in U.S. dollars.
During the nine months ended September 30, 2026, the euro depreciated against the U.S. dollar, resulting in a $5.5 million unfavorable foreign currency translation adjustment recognized in other comprehensive loss and a $6.2 million unfavorable effect of exchange rate changes on cash and cash equivalents. The U.S. dollar has remained broadly strong against the euro during this period, driven by persistent interest rate differentials and macroeconomic uncertainty, contributing to continued EUR/USD volatility. Continued depreciation of the euro against the U.S. dollar would further reduce the U.S. dollar value of the Company's euro-denominated cash and net assets, potentially accelerating the effective utilization of its liquidity.
The Company utilizes foreign exchange swap instruments to manage a portion of this exposure, as described in Note 9 to the condensed consolidated financial statements; however, there can be no assurance that such measures will fully offset the impact of adverse currency movements on the Company's results of operations, cash flows, or financial condition.
Sources of Liquidity and Material Cash Requirements
Since its inception and through September 30, 2026, the Company has raised $1,753.7 million in aggregate equity financing to fund its research and development activities, commercial preparedness, and general corporate operations. The following table summarizes the gross proceeds received from each financing transaction through the issuance of securities:
| In Million dollars | Equity capital | ||||||||||||||||
| Before 2023 | 1,309.7 | ||||||||||||||||
| 2023 | 7.8 | ||||||||||||||||
| 2025 | 291.5 | ||||||||||||||||
| 2026 | 144.7 | ||||||||||||||||
| Total | 1,753.7 | ||||||||||||||||
In June 2022, the Company announced an aggregate $194 million private investment in public equity (“PIPE”) financing from the sale of 32,855,669 ordinary shares, as well as pre-funded warrants to purchase up to 28,276,331 ordinary shares. The ordinary shares were sold to the purchasers at a price per ordinary share of €3.00 (corresponding to $3.22), and the pre-funded warrants at a pre-funded price of €2.90 (corresponding to $3.11) per pre-funded warrant, which equals the per share price for the ordinary shares less the remaining €0.10 exercise price for each such pre-funded warrant.
In March 2025, the Company completed a PIPE financing generating initial gross proceeds of $125.5 million (€116.3 million), followed by the full exercise of associated warrants in January 2026 after the announcement of positive Phase 3 VITESSE topline results, resulting in additional gross proceeds of $195.4 million (€166.7 million at 1 EUR = $1.17). Of the additional gross proceeds, $100.7 million was received as of December 31, 2025 and the remaining $94.7 million (€81.0 million at the exchange rate of 1 EUR = $1.17) was received in January 2026.
In September 2025, the Company entered into an at-the-market sales agreement (the “Sales Agreement”) with Citizens JMP Securities, LLC (“Citizens”), under which the Company may offer and sell, from time to time and at its sole discretion, ADSs through Citizens. Citizens is entitled to commissions of up to 3.0% of the gross proceeds from ADSs sold under the Sales Agreement. During the fourth quarter of 2025, the Company raised$65.0 million in gross proceeds from the sale of 4,790,552 ADSs under the Sales Agreement.
The shelf-registration statement on Form S-3 under which the Sales Agreement was established expired in April 2026, and in July 2026 the Company filed a new automatically effective shelf registration statement on Form S-3ASR, which includes a base prospectus and a sales agreement prospectus supplement refreshing the ATM Program by filing a prospectus supplement for the sale of up to $150.0 million of ADSs. During the nine months ended September 30, 2026, the Company completed the sale of $50.0 million in gross proceeds of ADSs to RA Capital Management, L.P. under the Sales Agreement. In connection with this transaction, the Company issued 18,288,220 new ordinary shares, underlying 3,657,644 new ADSs, at an at-the-market price of $13.67 per ADS. The additional capital further strengthened the Company’s financial resources as it advanced the BLA submission and continued to invest in clinical development, manufacturing readiness and preparations for the potential commercialization of VIASKIN® Peanut, if approved.
The Company also seeks to optimize the return on its available cash through short-term investments, which generate interest income while preserving liquidity for anticipated operating and strategic requirements. In addition, the Company benefits from refunds of research tax credits (crédit d’impôt recherche) available in France in connection with qualifying research and development activities.
The Company further actively manages excess liquidity through low-risk, interest-bearing investments, generating financial income while preserving flexibility to fund its operating and strategic priorities. The Company also benefits as an SME status from research tax credit (crédit d’impôt recherche) refunds in France related to qualifying research and development activities.
Material expenses commitments
The Company expects future cash requirements to be driven primarily by the continued advancement of its clinical programs, BLA readiness activities, commercial launch preparedness, manufacturing scale-up initiatives, operating lease obligations and contractual commitments under strategic manufacturing and supply agreements, including arrangements with Sanofi and Fareva. Further information regarding these commitments is provided in Note 14 to the condensed consolidated financial statements.
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The commitment amounts are based on contractual obligations that incorporate fixed or minimum service commitments, fixed, minimum, or variable pricing mechanisms, and the anticipated timing of the related contractual activities. Future events could cause actual payments to differ from these estimates. The Company continues to monitor geopolitical and macroeconomic developments and, while such conditions may affect future operating costs, supply chains and foreign exchange markets, management does not believe they have had a material impact on the Company's condensed consolidated financial statements as of September 30, 2026.
Forward-looking
As of September 30, 2026, the Company had cash and cash equivalents of $165.7 million. During the third quarter of 2026, the Company achieved significant regulatory and financing milestones, including the submission of its BLA for VIASKIN® Peanut in children ages 4 through 7 on September 29, 2026, for which the Company requested Priority Review, and the sale of $50.0 million in gross proceeds of ADSs under its ATM Program in July 2026. Following the BLA submission, management updated the Company’s operating and liquidity forecasts to reflect the potential regulatory review pathway and the anticipated timing of related clinical, regulatory, manufacturing and commercial readiness activities. The Company’s forecasts incorporate milestone-based spending assumptions designed to align the timing of certain expenditures with potential regulatory developments while continuing to advance activities necessary to support regulatory review and potential commercialization. Based on its current operations, plans and assumptions, the Company estimates that its existing cash and cash equivalents will be sufficient to fund operations into the third quarter of 2027.
As such, Management has concluded that the Company's existing cash and cash equivalents are not sufficient to fund its operations for at least twelve months from the date of issuance of these interim condensed consolidated financial statements. Accordingly, substantial doubt exists about the Company's ability to continue as a going concern within twelve months after the date these condensed consolidated financial statements are issued.
The Company will require additional capital to fund its operations. Management is actively evaluating multiple financing alternatives, including, without limitation, potential additional sales under the Company’s existing ATM Program, equity transactions, warrants exercise and other alternative forms of financing. The Company’s continued advancement through the regulatory review process may provide additional financing opportunities. However, the availability, timing and terms of any additional financing will depend on regulatory developments, market conditions and investors’ interest, lenders and other counterparties, and there can be no assurance that additional financing will be available when needed, on acceptable terms or at all.
Smaller Reporting Company Status
We are currently a “smaller reporting company” as defined in Rule 12b-2 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and have taken advantage of certain scaled disclosure accommodations available to smaller reporting companies in this and prior filings. However, as of June 30, 2026, the last business day of our second fiscal quarter, the market value of our voting and non-voting ordinary shares held by non-affiliates exceeded $700.0 million. As a result, based on the current SEC reporting framework, we will no longer qualify as a smaller reporting company effective January 1, 2027.
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.
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Item 4. Controls and Procedures
Disclosure Controls and Procedures
Based on its evaluation as of September 30, 2026, 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 or fraud may occur and not be detected.
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PART II – OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, the Company may become subject to various legal proceedings and claims that arise in the ordinary course of our business activities. The Company is not currently subject to any material legal proceedings.
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 and in Part II, Item 1A of our Quarterly Report on Form 10-Q for the Quarter ended June 30, 2026. There have been no material changes in our risk factors from those disclosed in the Annual Report except as follows:
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, 2026 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, 2026, we had unrestricted cash, cash equivalents and marketable securities of $165.7 million consisting of cash and investments. Subsequent to September 30, 2026, we raised additional proceeds of approximately $50 million total gross proceeds through the Company’s ATM Program. 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.
Relying on third-party manufacturers may result in delays in our clinical development or commercialization efforts.
Developing and commercializing new medicines entails significant risks and expenses. Our clinical trials may be delayed if third-party manufacturers are unable to assure a sufficient quantity of the drug product to meet our study needs. Currently, we have only one manufacturer, Sanofi S.A., or Sanofi, of the API used in our Viaskin product candidates, including Viaskin Peanut patch, such as peanut protein extract and unmodified allergen milk extract. In February 2020, Sanofi announced that it planned to create a new company dedicated to the production and marketing to third parties of API. Subsequently, Sanofi consolidated its API commercial and development activities conducted in six of its European API production sites. While those API sites do not include the site in which the API used in our Viaskin product candidates is produced, there can be no assurances that this transition will not adversely impact our supply of API from Sanofi. If Sanofi does not continue to manufacture the API as required by us in a timely manner, we may not be able to find a substitute manufacturer on a timely basis and our commercialization efforts and clinical trials may be delayed. Notwithstanding contractual protections, Sanofi may be able to utilize knowledge gained through their relationship with us in furtherance of their development of competitive therapies.
In December 2025, Stallergenes Greer announced that it intends to discontinue the commercialization of Palforzia, on July 31, 2026, for business reasons.
•We also expect to rely on Sanofi and on FAREVA for the manufacturing of the patch and on other third-party manufacturers for the manufacturing of commercial supply of Viaskin Peanut, if approved, and any other product for which we obtain regulatory approval. Sanofi may not be able to effectively scale its manufacturing capacity of our API to meet our commercialization needs and we may be unable to establish any agreements with other third-party manufacturers or to do so on acceptable terms. Even if Sanofi is able to meet our commercialization needs or if we are able to establish agreements with other third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:reliance on the third party for regulatory compliance and quality assurance;
•the possible breach of the manufacturing agreement by the third party;
•the possible misappropriation of our proprietary information, including our trade secrets and know-how; and
•the possible termination or non-renewal of the agreement by the third party at a time that is costly or inconvenient for us.
Once regulatory approval is obtained, a marketed product and its manufacturer are subject to continual review. The discovery of previously unknown problems with a product or manufacturer may result in restrictions on the product, manufacturer or manufacturing facility, including withdrawal of the product from the market. Manufacturers of products with which we contract are required to operate in accordance with FDA-mandated cGMPs or comparable GMP requirements in foreign countries. A failure of any of our contract manufacturers to establish and follow cGMPs and to document their adherence to such practices may lead to significant delays in the launch or availability of products based on our product candidates into the market. Moreover, the constituent parts of a combination product retain their regulatory status (as a biologic or medical device, for example) and, as such, we or our contract manufacturers may be subject to additional requirements in the QSR or comparable quality management systems in foreign countries, applicable to medical devices, such as design controls, purchasing controls, and corrective and preventive action. We, our contract manufacturers, any future collaborators and their contract manufacturers could be subject to periodic unannounced inspections by the FDA or other comparable foreign regulatory authorities, to monitor and ensure compliance with cGMP. Despite our efforts to audit and verify regulatory compliance, one or more of our third-party manufacturing vendors may be found on regulatory inspection by the FDA or other comparable foreign regulatory authorities to be noncompliant with cGMP regulations. Failure by third-party manufacturers to comply with applicable regulations could result in sanctions being imposed on us, including shutdown of the third-party vendor, fines, injunctions, civil penalties, revocation or suspension of regulatory approval for any products
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granted pre-market approvals, invalidation of drug product lots or processes, seizures or recalls of products, operating restrictions, and criminal prosecutions.
We have been informed by FAREVA Amboise (“FAREVA”), our sole contract manufacturer for Viaskin Peanut patches, that the FDA has issued warning letters to FAREVA identifying certain current Good Manufacturing Practice (“cGMP”) deficiencies, including at the FAREVA facility at which our Viaskin Peanut patches are manufactured. We are working collaboratively with FAREVA on its ongoing remediation and mitigation efforts in response to these warning letters. If FAREVA is unable to remediate these deficiencies to the FDA's satisfaction in a timely manner, or if the FDA takes further enforcement action with respect to the FAREVA Amboise facility, our ability to manufacture Viaskin Peanut patches for our clinical trials or, if approved, for commercial supply could be materially and adversely affected. Because FAREVA is currently our sole manufacturer of Viaskin Peanut patches, we do not have an alternative manufacturing source to which we could readily transition, and any interruption or restriction on manufacturing at the FAREVA Amboise facility could significantly delay our clinical development and regulatory timelines, including timing of the filing, acceptance or approval of our anticipated BLA submission for the Viaskin Peanut patch in children ages 4 through 7 years, and could have a material adverse effect on our business, results of operations, and financial condition.
Since the FDA’s warning letters, FAREVA has confirmed that it has responded to the FDA in accordance with applicable regulatory timelines and provided monthly remediation updates.
Our current and anticipated future dependence upon others for the manufacture of our product candidates or products, if approved, may adversely affect our future profit margins and our ability to commercialize any products that receive regulatory approval on a timely and competitive basis.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
During the Three Months Ended September 30,2026, none
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 | ||||||||||||||||
30
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
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, 2026 | By: | /s/ Daniel Tassé | ||||||
Daniel Tassé | ||||||||
Chief Executive Officer | ||||||||
(Principal Executive Officer) | ||||||||
Date: October 28, 2026 | By: | /s/ Virginie Boucinha | ||||||
Virginie Boucinha | ||||||||
Chief Financial Officer | ||||||||
(Principal Financial and Accounting Officer) | ||||||||
31
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, 2026
/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, 2026
/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, 2026, 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, 2026
/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.
BY-LAWS
(Updated by decision of the Chief Executive Officer on August 31, 2026)
____________________
DBV Technologies
Limited Company with share capital of € 31,438,880.70
107, avenue de la République - 92320 Châtillon, France
Nanterre Trade and Companies Register No. 441 772 522
I. - CHARACTERISTIC FEATURES OF THE COMPANY
Article 1 - Form
The Company was incorporated in the form of a French Limited Company (Société Anonyme) with a Board of Directors.
Article 2 - Name
The name of the Company is: “DBV Technologies”.
Article 3 - Registered office
The registered office is located at: 107, avenue de la République, 92320 Châtillon, France.
Article 4 - Corporate Purpose
The Company’s corporate purpose in France and in all countries is:
•the development of any innovative medical products, including any drugs, or diagnostic or treatment products;
•the study, research, development, industrial manufacturing, and marketing of said products;
•the use and development of any patents or licenses relating to these products, and generally speaking any commercial, investment or real estate, financial or other transactions that are directly or indirectly related to the corporate purpose in whole or in part, or to any other similar or related purpose, and that may promote the operation and commercial development of the Company.
Article 5 - Term
The Company’s term is ninety-nine years as from its registration in the Trade and Companies Register.
Article 6 - Share capital
The share capital has been set at €31,438,880.70.
It is divided into 314,388,807 ordinary shares with a par value of 10-euro cents (€0.10) each. All of the shares have been fully subscribed, and their full amount paid up in cash.
Article 7 - Changes to the share capital
I. The share capital may be increased either via the issue of new shares, or by increasing the par value of the existing shares.
The new shares will be paid for in cash, or via a contribution in kind, offset against liquid and due receivables, or via the incorporation of profits, reserves, or share premiums into the share capital, either as the result of a merger or demerger, or following the exercise of a right attached to transferable securities granting entitlement to the share capital, including payment of the corresponding amounts, where applicable.
The new equity securities will be issued either at their par value, or at that amount plus a share premium.
Only the Extraordinary General Meeting of Shareholders has the power to decide on increasing the share capital, based on a report from the Board of Directors containing the disclosures required by law.
However, the Extraordinary General Meeting of Shareholders may delegate this power to the Board of Directors under the conditions determined by law. The Board of Directors has the requisite powers to perform a capital increase in one or several installments, to determine its terms and conditions, to record its completion, and to amend the By-Laws accordingly within the limits of the powers so granted by the Extraordinary General Meeting of Shareholders.
If the General Meeting of Shareholders decides to increase the share capital, it may delegate the powers required to perform the transaction to the Board of Directors.
If a delegation of power or of authority is used, the Board of Directors will draw up a supplementary report at the next Ordinary General Meeting of Shareholders.
If the capital increase is performed via the incorporation of profits, reserves, or share premiums, the Extraordinary General Meeting of Shareholders will take decisions under the quorum and majority conditions provided for Ordinary General Meetings of Shareholders. In this case, it may decide that rights amounting to fractional shares may neither be traded nor transferred, and that the corresponding equity securities must be sold. The proceeds from the sale will be allocated to the holders in proportion to their rights.
A capital increase by increasing the par value of the shares can only be decided with the shareholders’ unanimous consent, except if it results from the incorporation of profits, reserves, or share premiums into the share capital.
Shareholders will have a preferential right to subscribe to the cash shares issued in order to perform a capital increase, in proportion to the number of shares that they hold. The shares purchased as a result of exercising this right will be shares in the same class as the one for the shares giving rise to said right, together with the shares resulting from the purchase of other transferable securities than shares.
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The shareholders may sell all or some of their subscription rights throughout the subscription period. These rights will be tradable if they are stripped from shares that are themselves tradable. Otherwise, they may be sold under the same conditions as the actual shares.
Shareholders may waive their preferential subscription right on an individual basis.
The Extraordinary General Meeting of Shareholders that decides on the capital increase may waive the preferential subscription right under the conditions and limits determined by law, and rule to that effect on the reports prepared by the Board of Directors and the Statutory Auditors under the conditions determined by the laws and regulations in effect.
If the Extraordinary General Meeting of Shareholders, or the Board of Directors in the event of a delegation of authority, has expressly decided to do so, any shares that have not been subscribed on an irrevocable basis will be allotted to shareholders who subscribed to a higher number of shares on a revocable basis than the number to which they were able to subscribe on a preferential basis, in proportion to the subscription rights that they hold, and within the limits of their request, in any event.
If, for any reason, subscriptions have not absorbed the full amount of the capital increase, the Board of Directors may use the options provided for below, or only some of them, in the order that it determines:
(i) limiting the capital increase to the amount of the subscriptions, subject to the general condition that it amounts to at least three quarters of the increase decided upon, and that this option was not expressly excluded by the Extraordinary General Meeting of Shareholders at the time of issue;
(ii) allocating the balance of the shares if the Extraordinary General Meeting of Shareholders has not decided otherwise;
(iii) opening the subscription process to the public if the Extraordinary General Meeting of Shareholders has expressly authorized it.
If subscriptions have not absorbed the entire capital increase following the exercise of these options, or three-quarters of the increase in the case provided for under (i) above, the capital increase will not be performed.
However, the Board of Directors may automatically limit the capital increase to the amount raised in all cases where the unsubscribed shares account for less than 3% of the capital increase.
In the event of a capital increase with or without preferential subscription rights, the Extraordinary General Meeting of Shareholders may provide that the number of securities may be increased by up to 15% of the initial issue, at the same price as the one used for the initial issue within a period of thirty days following the close of the subscription period.
If the capital increase creates fractions of shares, shareholders who have an insufficient number of subscription or allotment rights must make arrangements to purchase or sell the rights required to obtain the delivery of a whole number of new shares.
II. The Extraordinary General Meeting of Shareholders (or the Board of Directors in the event of a delegation of authority) may also authorize or decide on a capital decrease, subject to the rights of creditors, where applicable.
Decreasing the share capital below the legal limit can only be decided under the condition precedent of a capital increase intended to return the share capital to an amount that is at least equal to the minimum legal threshold, unless the Company turns itself into a company with another legal form. Otherwise, any interested party may apply to the courts to have the Company wound up. The court may not order the Company to be wound up if the amount of the share capital has been restored to the statutory minimum by the day when it rules on the substance of the case.
Article 8 - Financial year
The financial year runs from January 1 to December 31.
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II. - ADMINISTRATION OF THE COMPANY
Article 9 - Executive Management exercise method
The executive management of the Company is the responsibility either of the Chairman of the Board of Directors or of another individual appointed by the Board of Directors bearing the title of Chief Executive Officer.
The Board of Directors chooses between the two Executive Management exercise methods based on the unanimous vote of all of its members.
Where responsibility for the Company’s Executive Management is held by the Chairman of the Board of Directors, the following provisions concerning the role of Chief Executive Officer apply.
A. The Board of Directors
Article 10 - Composition of the Board of Directors
The Company is governed by a Board of Directors that consists of between 3 and 18 directors.
The Directors are appointed by the General Meeting of Shareholders, deliberating under the quorum and majority conditions for Ordinary General Meetings of Shareholders.
The term of office for the Directors appointed during the term of the company is three (3) years. This term expires at the end of the meeting convened to approve the financial statements for the year just ended, and which is held in the year during which their term of office expires.
By way of exception and in order to allow exclusively for the implementation or maintenance of the staggered terms of office of Directors, the ordinary General Meeting of Shareholders may appoint one or more members of the Board for a term of two (2) years or one (1) year.
The Directors may be dismissed at any time and without any good reason by the General Meeting of Shareholders, deliberating under the quorum and majority conditions for Ordinary General Meetings of Shareholders.
The number of Directors aged over eighty cannot exceed one third of the Board members.
Article 11 - Board Discussions
The Board of Directors meets as often as is required by the Company’s interests at the invitation of the Chairman of the Board of Directors, at the registered office or the place specified in the notice of meeting. The invitation may be issued by any means five calendar days in advance: it may also be issued orally and immediately if all of the Directors and non-voting Board members agree.
For the purposes of calculating the quorum and majority, Directors who participate in the meeting by a means of telecommunication that enables them to be identified, in accordance with legal and regulatory provisions, are deemed to be present.
Directors may vote by correspondence at a meeting of the Board of Directors by means of a form containing the information required by the regulations in force, if this method of voting is provided for in the notice convening the meeting of the Board of Directors.
If it has not met for over two months, at least one quarter of the members of the Board of Directors may ask the Chairman to convene the Board based on a determined agenda. The Chief Executive Officer or a Director may also ask the Chairman to convene the Board of Directors based on a determined agenda. The Chairman will be bound by any such requests.
An attendance register will be kept, and minutes will be drawn up following each meeting. The Board may only validly take decisions if at least half of its members are present.
Except where the choice of the method for exercising Executive Management is concerned, decisions will be taken based on a majority vote of the Directors present or represented. The Chairman will have a casting vote in the event that the vote is split.
The Board of Directors may also take decisions by written consultation of the Directors.
The decision to resort to written consultation is taken by the Chairman, who sends each Director, by e-mail, the text of the proposed decisions as well as any documents required for information purposes.
Any Director may object to the use of written consultation for the adoption of a decision, by informing the Chairman by e-mail within two working days of the date of dispatch of the draft decisions. The Chairman is bound by any objections sent to him pursuant to this paragraph.
Directors have a period of five calendar days (ending at 11:59 p.m., Paris time, on the last day of this period) from the date on which the draft decisions are sent to cast their vote in writing. Responses are sent by e-mail to the attention of the Chairman of the Board of Directors.
The Board of Directors may only validly deliberate on a written consultation if at least half of its members have replied within the time limit indicated above.
Decisions are taken by a majority of the votes of the members who have replied, each member having one vote. The Chairman will have a casting vote in the event that the vote is split.
Decisions taken by written consultation are recorded in minutes drawn up by the Chairman.
The Directors and any individuals asked to attend the Board of Directors’ meetings are required to exercise discretion with respect to information of a confidential nature, and which is provided as such by the Chairman of the Board of Directors.
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Article 12 - The Board’s powers
The Board of Directors determines the Company’s guidelines, and ensures their implementation. Subject to the powers specifically assigned to General Meetings of Shareholders, and within the limits of the corporate purpose, the Board will deal with any matter involving the proper operation of the Company, and settle any matters concerning it through its discussions.
The Board of Directors carries out the controls and verifications that it considers appropriate. Every Director will receive all of the information required to fulfill their assignment, and may ask for the disclosure of any documents that they consider useful.
Article 13 - The Chairman of the Board of Directors
The Board of Directors elects a Chairman, who must be a private individual, from among its members, and determines their remuneration, in accordance with applicable law. The Chairman is appointed for a period that may not exceed the length of their term of office as a Director. They are eligible for re-election. The Board of Directors may dismiss the Chairman at any time. Any provisions to the contrary will be considered void.
No one aged 75 or over may be appointed as Chairman. If the incumbent Chairman reaches this age during a financial year, their duties will automatically end following the Ordinary General Meeting of Shareholders convened to approve the financial statements for that financial year.
The Chairman organizes and directs the work undertaken by the Board, and accounts for it at the General Meeting of Shareholders. They ensure that the Company’s bodies operate properly, and especially that the Directors are in a position to fulfill their assignment.
Article 14 - Non-Voting Board Members
The General Meeting of Shareholders may appoint one or two non-voting Board members for the Company who are private individuals, regardless of whether they are shareholders; they will be aged 65 at most on the day of their appointment.
Non-voting Board members are appointed for a period of two (2) years. Their assignment ends after the General Meeting of Shareholders that has approved the financial statements for the year just ended, and held in the year during which their term of office expires.
Non-voting Board members do not receive any remuneration. They may receive allowances determined by the Board of Directors in order to reimburse the expenses that they are required to incur as part of the normal performance of their duties. If the Board delegates a specific assignment to the non-voting Board members or to one of them, they may allocate them an allowance in proportion to the importance of the assignment entrusted to them, as well as a budget for performing said assignment. Non-voting Board members are invited to all of the Board of Directors’ meetings and to all of the General Meeting of Shareholders, and take part in the discussions in an advisory capacity. Non-voting Board members perform a general and permanent advisory and supervisory role at the Company. However, they may not interfere in the management of the Company under any circumstances, or, in general, replace its legal bodies.
B. The Executive Management
Article 15 - Chief Executive Officers and Deputy Chief Executive Officers
The executive management of the Company is the responsibility of a private individual appointed by the Board of Directors bearing the title of Chief Executive Officer, under the Company’s responsibility.
The Board of Directors may appoint one or more private individuals responsible for assisting the Chief Executive Officer, who will bear the title of Deputy Chief Executive Officer, on the recommendation of the Chief Executive Officer. The number of Deputy Chief Executive Officers cannot exceed five.
The Chief Executive Officer may be dismissed by the Board of Directors at any time. The same applies to the Deputy Chief Executive Officers, on the recommendation of the Chief Executive Officer. If the dismissal is not on justified grounds, it may result in the payment of damages and interest.
Where the Chief Executive Officer ceases, or is otherwise prevented from performing their duties, the Deputy Chief Executive Officers will retain their positions and their assignments until a new Chief Executive Officer is appointed, unless the Board decides otherwise.
The Board of Directors determines the compensation paid to the Chief Executive Officer and the Deputy Chief Executive Officers, in accordance with applicable law.
Article 16 - Powers of the Chief Executive Officer and Deputy Chief Executive Officers
The Chief Executive Officer is granted very extensive powers to act in the Company’s name in all circumstances. They exercise the powers within the limit of the corporate purpose, and subject to those that the law and these By-Laws expressly assign to General Meeting of Shareholders and to the Board of Directors.
They represent the Company in its dealings with third parties. The Company will be committed even by the Chief Executive Officer’s actions that do not relate to the corporate purpose, unless it proves that the third party was aware that the action exceeded that purpose, or could not ignore this fact in view of the circumstances. The sole publication of the By-Laws does not amount to sufficient proof.
The Board of Directors determines the scope and term of the powers granted to the Deputy Chief Executive Officers, with the Chief Executive Officer’s consent. The Deputy Chief Executive Officers have the same powers as the Chief Executive Officer where third parties are concerned.
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III. - GENERAL MEETING OF SHAREHOLDERS
Article 17 - General Meeting of Shareholders
The duly constituted General Meeting of Shareholders represents the entire body of shareholders.
Its decisions, which are taken in accordance with the law and the By-Laws, are binding on all of the shareholders, even if they are absent, disagree, or are incapable.
There are three forms of meetings, depending on the purpose of the resolutions put forward:
•Ordinary General Meetings;
•Extraordinary General Meetings;
•Special Meetings that bring together the holders of shares in a given class.
Article 18 - Invitations
The Meetings are convened by the Board of Directors. They may also be convened by the Statutory Auditor or by a court representative, under the conditions and in accordance with the procedures provided for by law.
Meetings are convened by the liquidator(s) during the liquidation period.
The Meetings are held at the registered office or at any other location specified in the notice of meeting.
A notice of meeting is published in the Bulletin des Annonces Légales Obligatoires (French Official Gazette, or BALO) at least thirty-five days before a Meeting is held. In addition to the information relating to the Company, the notice specifies the agenda for the Meeting, and the wording of the draft resolutions that will be put forward. Requests to enter points or draft resolutions on the agenda must be addressed to the Company under the conditions provided for by the regulations in effect.
The Meetings are held at the registered office or at any other location specified in the notice of meeting.
Subject to specific legal provisions, the invitation is issued at least fifteen days before the date of the Meeting by a notice inserted in a legal gazette published in the Department where the registered office is located, as well as in the BALO.
The holders of registered shares must be convened under the conditions provided for by the regulations in force.
The notice of meeting must also specify the conditions under which shareholders may vote by post, and the places where, and terms and conditions according to which, they may obtain postal vote forms.
The notice of meeting may be sent, where applicable, with a proxy form and a postal voting form, under the conditions specified in Article 21 of these Articles of Association, or with a postal voting form only, under the conditions specified in Article 21 of these Articles of Association.
Where a Meeting has been unable to take decisions as a result of failing to achieve the quorum required, a second Meeting will be convened, subject to specific legal provisions, at least ten days in advance, in the forms provided for by the regulations in effect.
Article 19 - Agenda
The agenda for Meetings will be prepared by the person convening the meeting.
One or several shareholders, who represent at least the percentage of the share capital specified by law, and acting in accordance with the legal conditions and timeframes, have the option to request the inclusion of points or draft resolutions on the agenda for the Meeting, via registered letter with a request for acknowledgment of receipt.
The Meeting may not discuss an issue that has not been entered on the agenda, which cannot be altered at the time of the second invitation. However, it may dismiss one or several members of the Board of Directors, and replace them in all circumstances.
Article 20 - Participation of Shareholders in Meetings
Any shareholder may participate, personally or by proxy, in the meetings upon proof of identity and ownership of his or her shares, in accordance with the procedures provided for by the laws and regulations in force.
Article 21 - Postal and proxy voting
Postal voting is carried out in accordance with the terms and conditions laid down by the legal and regulatory provisions. In particular, any shareholder may send postal voting forms either in paper form or, if the Board of Directors decides to do so and publishes the decision in the notice of meeting, by electronic means, before the meetings. Proxy forms may be sent either in paper form or by electronic means before the meetings.
If the Board of Directors decides at the time of convening the meeting to allow the transmission of voting or proxy forms by electronic means, the electronic signature of these forms may result from a reliable process for identifying the shareholder, guaranteeing its link with the remote form to which its signature is attached. The vote thus expressed before the meeting by this electronic means, as well as the acknowledgement of receipt given, will be considered as non-revocable writings and opposable to all. The proxy is however revocable in the same way as those required for the appointment of the proxy. In the event of a transfer of ownership of securities occurring before midnight (Paris time) on the second business day preceding the meeting, the Company will invalidate or modify accordingly, as the case may be, the proxy or the vote cast before the meeting by this electronic means.
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Article 22 - Attendance sheet
An attendance sheet containing the information specified by law will be kept at each Meeting.
This attendance sheet, duly initialed by the shareholders present and the proxies, and the shareholders attending via video-conference or another means of telecommunication, in accordance with the legal and regulatory requirements, and to which the powers granted to each representative are appended, together with the postal voting forms, will be certified as accurate by the Meeting Bureau.
The Meetings will be chaired by the Chairman of the Board of Directors. Otherwise, the Meeting will elect its own Chairman.
The tellers’ duties will be performed by two shareholders who are present and agree to do so, and who represent the highest number of votes, both on their own behalf and as proxies.
The Bureau formed in this way will appoint a secretary, who may be chosen from outside the shareholders.
Article 23 - Voting rights attached to shares
The voting right attached to the shares is proportional to the percentage of the total share capital that they represent. Each equity share or dividend share will grant entitlement to one vote. Fully paid-up shares for which proof can be provided that they have been registered in the name of the same shareholder for at least two years do not benefit from double voting rights.
Article 24 - Minutes
The decisions taken at the Meetings will be recorded in minutes that are drawn up in a special ledger held at the registered office, and signed by the members of the Bureau.
Copies or excerpts of the minutes of the decisions will be certified either by the Chairman of the Board of Directors or by the Meeting Secretary. They will be validly certified by the liquidator(s) in the event of liquidation proceedings.
Article 25 - Disclosure of documents
Any shareholder has the right to obtain disclosure of, and the Board of Directors is required to send or make available to them, the documents required to enable them to form an opinion in full knowledge of the facts, and to make an informed judgment on the Company’s management and operations.
The nature of these documents, and the conditions for sending them or making them available to the shareholders are determined by the regulations in effect.
Every shareholder or their representative may seek the assistance of an expert registered on one of the lists drawn up by the courts, in order to exercise their right of disclosure.
The exercise of the right of disclosure entails the right to take copies, except where records are concerned.
Article 26 - Ordinary General Meeting of Shareholders
The Ordinary General Meeting of Shareholders takes all of the decisions that exceed the powers of the Board of Directors and which do not fall within the remit of the Extraordinary General Meeting of Shareholders.
The Meeting is convened at least once a year, within a period of six months following the end of each financial year, in order to approve the financial statements for that year, subject to this period being extended by an order from the Presiding Judge of the Commercial Court ruling at the request of the Board of Directors.
The Meeting is convened on an extraordinary basis every time that this appears to be in the Company’s interests.
When convened for the first time, the Ordinary General Meeting of Shareholders may only validly deliberate if the shareholders present, represented, or who have voted by post hold at least one fifth of the shares to which voting rights are attached.
No quorum is required if the meeting is convened for a second time and the original agenda has not been amended.
The Ordinary General Meeting of Shareholders decides by a majority of the votes expressed by the shareholders present, represented or voting by mail. The expressed votes do not include those attached to shares for which the shareholder has not taken part in the vote, has abstained or has voted blank or null.
Article 27 - Extraordinary General Meeting of Shareholders
The Extraordinary General Meeting of Shareholders is authorized to amend all of the provisions of the By-Laws, and to specifically decide on turning the Company into a company with another legal form. It cannot, however increase the shareholders’ undertakings, except in the case of transactions resulting from a duly executed reverse share split.
The Board of Directors may make the necessary amendments to the By-Laws to bring them into line with legislative and regulatory provisions, subject to ratification of these amendments by the next Extraordinary General Meeting of Shareholders.
The Extraordinary General Meeting of Shareholders may only validly deliberate if the shareholders present, represented or who have voted by post hold at least one quarter of the shares with voting rights at the time of the first invitation, and one fifth of the shares with voting rights at the time of the second invitation. If the second quorum is not achieved, the second Meeting may be postponed to a date no later than two months after the date on which it was convened.
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The Meeting passes resolutions based on a two-thirds majority vote expressed by the shareholders who are present, represented, or have voted by post, or who are attending the Meeting via video-conference or another means of telecommunication, in accordance with the legal and regulatory provisions.
As a legal exemption to the above provisions, a General Meeting of Shareholders that decides on a capital increase via the capitalization of reserves, profits, or share premiums may pass resolutions under the same quorum and majority conditions as an Ordinary General Meeting of Shareholders.
Furthermore, where the Extraordinary General Meeting of Shareholders is required to discuss the approval of a contribution in kind or the granting of a particular benefit, the shares held by the individual making the contribution or the beneficial owner will not be taken into account to calculate the majority. The individual making the contribution or the beneficial owner will not have a vote, either on their own behalf, or as a proxy.
Article 28 - Special meeting
If there are several share classes, no change may be made to the rights attached to shares in one of these classes without a due vote at an Extraordinary General Meeting of Shareholders open to all shareholders and, furthermore, without an equally compliant vote at a Special Meeting open only to the holders of shares in the class in question.
Special Meetings may only validly discuss matters if the shareholders present, represented, who have voted by post, or who are attending the Meeting via video-conference or via another means of telecommunication in accordance with the legal and regulatory provisions, hold at least one third of the shares with voting rights, where an amendment to those rights is planned, on the first invitation, and one fifth of the shares on the second invitation. Otherwise, the second Special Meeting may be postponed to a date no later than two months after the date on which it was convened.
Special Meetings pass resolutions based on a two-thirds majority of the expressed votes of the shareholders present or represented.
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IV. - THE COMPANY’S SECURITIES
Article 29 - Payment for the shares
At least 25% of the par value of shares subscribed in cash must be paid at the time of subscription, together with the full share premium, where applicable.
The balance must be paid in one or several installments, as called by the Board of Directors, and within a period of five years from the date on which the capital increase was finalized.
Calls for funds are made known to the shareholders via a notice published in the BALO fifteen (15) days in advance.
If the shareholder does not make the required payments on the amount of the shares to which they have subscribed at the times determined by the Board of Directors, these payments will automatically bear interest payable to the Company at the legal rate determined in Article L. 313-2 of the French Monetary and Financial Code, as from the end of the month following the date when they are due, without any requirement for a court application or letter of notice. Furthermore, shares for which the required payments have not been made at the end of a period of 30 days as from the sending of a letter of notice to the defaulting shareholder, to which no reply has been received, will no longer grant the right to attend General Meetings of Shareholders and to vote at those Meetings, and will be deducted from the quorum calculation. The right to dividends, and the preferential right to subscribe to capital increases attached to the shares will be suspended. These rights will be recovered once the capital and interest amounts due have been paid. The shareholder may then request the payment of dividends that have not expired, and exercise their preferential subscription right, if the determined timeframe for exercising that right has not expired.
The share capital must be fully paid up before any issue of new shares to be paid for in cash.
Article 30 - Form of the shares - Management of the securities accounts
The shares may be in registered or bearer form, if the legislation allows, depending on the shareholder’s choice.
Issued shares give rise to a registration in individual accounts in the name of each shareholder opened by the Company or any authorized intermediary. These accounts are held under the conditions and in accordance with the procedures provided for by the legal and regulatory provisions.
In order to identify the owners of bearer shares, the company may, under the conditions provided for by the legal and regulatory provisions in force, request, at any time, information concerning the owners of its shares and securities conferring immediate or future voting rights at its own General Meetings of Shareholders.
Article 31 - Transfer of the shares
Shares registered on an account are transferred from account to account.
Cash shares are freely tradable as from the completion of the capital increase. Shares resulting from contributions are freely tradable as from the completion of the capital increase, i.e. the date of the Meeting or of the meeting of the Board of Directors acting on a delegation of authority, which approved the contributions, in the event of a contribution in kind during the term of the company.
The transfer of ownership will result from their registration on the purchaser’s account, on the date and under the conditions determined by law and the applicable regulations, where applicable.
The shares will be freely tradable, subject to the provisions provided for by law.
Article 32 - Crossing of thresholds
Any private individual or legal entity referred to in Articles L. 233-7, L. 233-9, and L. 223-10 of the French Commercial Code who comes to directly or indirectly hold a number of shares representing a percentage of the Company’s share capital or voting rights higher than or equal to 2.5% or a multiple of that percentage, either on a stand-alone basis or in concert, must inform the Company of the total number of shares, voting rights, and securities granting access to the share capital or to voting rights immediately or in the future that they hold, via registered letter with a request for an acknowledgment of receipt sent to the registered office within a period of four trading days, prior to the market close as from the point when they crossed said percentage threshold(s).
The disclosure obligation provided for above also applies under the same conditions when each threshold mentioned above is crossed downwards.
If they have not been reported under the conditions specified above, shares or voting rights that exceed the percentage that should have been reported will be stripped of their voting rights at General Meetings of Shareholders at any Meeting that may be held until the expiry of a two-year period following the date when the notice of interest was made compliant, in accordance with Article L. 233-14 of the French Commercial Code, if a failure to report has been observed, and if one or several shareholders holding an interest of at least 2.5% have made a request recorded in the minutes of the General Meeting of Shareholders.
The above reports will apply notwithstanding the reports on the crossing of thresholds provided for by the legal or regulatory provisions in effect.
Article 33 - Rights and obligations attached to the shares
Each share entitles the holder to a share in the Company’s profits and assets, in proportion to the amount of capital that it represents.
Furthermore, each share entitles the holder to vote and be represented at General Meetings of Shareholders under legal and statutory provisions.
Shareholders will only be liable up to the amount of the par value of the shares that they hold; any calls for funds above that amount are prohibited.
Ownership of a share automatically entails adherence to the Company’s By-Laws and to the decisions of the General Meeting of Shareholders.
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Heirs, creditors, assigns, or other representatives of a shareholder will not be entitled to request seizure of the Company’s assets or securities, or ask for them to be shared out or sold at auction, nor interfere in administrative acts relating to the Company in order to exercise their rights; they must refer to the company records and to the resolutions of the General Meeting of Shareholders.
Whenever it is necessary to hold several shares in order to exercise a given right, such as in the case of an exchange, reverse share split or allotment of shares, or an increase or decrease in the share capital, or a merger or other corporate transaction, the holders of single shares, or of a lower number of shares than required, may only exercise these rights if they personally arrange for the consolidation, and potentially the purchase or sale of the shares required.
However, in the event of the exchange of securities following a merger or demerger transaction, a capital decrease, a reverse share split or share split, and the mandatory conversion of bearer shares to registered shares, or of the distribution of securities charged to the reserves relating to a capital decrease, or the distribution or allotment of bonus shares, based solely on a decision by the Board of Directors, the Company may sell securities that the beneficiaries have requested to be delivered to them, as long as it has carried out the publication formalities provided for in the regulations at least two years beforehand.
As from the sale, the old securities or the old rights to distributions or allotments will be canceled, as and when required, and their holders will only be able to claim the cash allocation of the net proceeds of the sale of the unclaimed securities.
Article 34 - Beneficial & Bare ownership
The shares are indivisible as regards the Company.
Joint owners of shares are required to have themselves represented to the Company by just one of them, who will be considered as the sole owner, or by a single proxy; in the event of disagreement, the single proxy may be appointed by a court at the request of the first joint owner to do so.
Unless the Company has been notified of an agreement to the contrary, the beneficial owners of shares will validly represent the bare owners with the Company. Voting rights will be held by the beneficial owner at Ordinary General Meetings of Shareholders and by the bare owner at Extraordinary General Meetings of Shareholders.
Unless otherwise agreed between the parties, the preferential subscription right attached to securities belongs to the bare owner where the shares are encumbered by a usufruct interest.
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V. - COMPANY FINANCIAL STATEMENTS
Article 35. - Preparation and approval of the company financial statements
a)The Board of Directors will draw up an inventory and the annual financial statements at the end of each financial year, and will then prepare the management report.
b) Where applicable, the Board of Directors will prepare and publish the consolidated financial statements, together with the report regarding the management of the Group.
c)The Ordinary General Meeting of Shareholders will approve the annual company financial statements within a period of six months following the financial year-end, after familiarizing itself with the management report and the report prepared by the Statutory Auditors; the consolidated financial statements and the report regarding the management of the Group will be presented at that Meeting, if required.
d) All information measures will be taken in compliance with the law and the regulations.
Article 36 - Audit of the financial statements
The financial statements will be audited by one or several incumbent, and, where applicable, alternate Statutory Auditors, under the conditions determined by Articles L. 225-218 of the French Commercial Code.
Article 37 - Allocation of the amounts available for distribution
Following the approval of the financial statements, and the recording of the existence of amounts available for distribution, the Ordinary General Meeting of Shareholders will determine the share of these amounts allotted to the shareholders in the form of a dividend; this dividend will be charged to the distributable profit for the year as a priority.
The procedures for paying the dividends or interim dividends are determined by the General Meeting of Shareholders.
Write-down differences are not available for distribution.
If required, the Meeting will allocate the non-distributed portion of the profit for the financial year available for distribution in the proportions that it determines, either to one or several reserves, which may be general or special, which remain at its disposal, or to the “retained earnings” account.
Any losses will be carried forward, unless the Meeting decides to offset them against existing reserves.
VI. - LIQUIDATION OF THE COMPANY
Article 38 - Liquidation
Once it has been wound up, the Company will be liquidated under the conditions determined by the French Commercial Code.
Unless the Ordinary General Meeting of Shareholders decides otherwise, the liquidator or liquidators will pursue any ongoing business until it is completed.
The net proceeds of the liquidation, following the settlement of the liabilities and payroll expenses, and repayment to the shareholders of the non-amortized par value of their shares, will be divided between the shareholders, taking the rights of the different share categories into account, where applicable.
Vll - MISCELLANEOUS ITEMS
Article 39 - Powers
All powers will be granted to the bearers of original copies of these By-Laws, or of copies or excerpts certified as original, in order to carry out all formalities.
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