DBV Technologies (DBVT) ramps Viaskin Peanut spending with $229M cash runway
Filing Impact
Filing Sentiment
Form Type
10-Q
DBV Technologies S.A. reported a larger net loss as it ramps up development and commercial preparation for its Viaskin Peanut patch. For the three months ended March 31, 2026, net loss widened to $47.6 million from $27.1 million a year earlier, driven by a sharp increase in operating expenses.
Research and development spending rose to $33.4 million, sales and marketing to $4.8 million, and general and administrative costs to $10.5 million, reflecting expanded clinical activity, pre-commercial inventory build, and build‑out of U.S. commercial and corporate infrastructure. There was still no product revenue; operating income of $0.9 million came mainly from the French research tax credit.
Following a 2025 PIPE financing and warrant exercises, DBV ended the quarter with $229.2 million in cash and cash equivalents, up from $194.2 million at year‑end 2025. Management estimates this cash should fund operations into the second quarter of 2027, assuming current plans focused on Viaskin Peanut, although faster spending or new programs could shorten that runway.
Positive
- None.
Negative
- None.
Insights
DBV is burning more cash to push Viaskin Peanut toward approval and launch, backed by a strengthened balance sheet.
DBV is still pre‑revenue and reported a net loss of $47.6 million for the quarter, with total operating expenses up 78% year over year to $48.8 million. The main drivers were higher clinical trial spending, pre‑commercial inventory, and rapid hiring across R&D, commercial, and G&A functions tied to Viaskin Peanut.
Cash and cash equivalents increased to $229.2 million, helped by the March 2025 PIPE warrant exercises that added $94.7 million in Q1 2026. Management believes this supports operations into Q2 2027. However, operating cash outflow rose to $49.1 million this quarter, and future burn will depend on regulatory timelines, manufacturing commitments, and commercial ramp‑up decisions.
Viaskin Peanut remains the core value driver, with BLA submission for children aged 4 to 7 planned in the first half of 2026. The company has also locked in long‑term manufacturing arrangements and CRO/CMO commitments totaling about $145.5 million over several years, which structurally commits future cash but supports scale‑up if approval and demand materialize.
Key Figures
Net loss: $47.6 million
Research and development expenses: $33.4 million
Sales and marketing expenses: $4.8 million
+5 more
8 metrics
Net loss
$47.6 million
Three months ended March 31, 2026
Research and development expenses
$33.4 million
Three months ended March 31, 2026
Sales and marketing expenses
$4.8 million
Three months ended March 31, 2026
General and administrative expenses
$10.5 million
Three months ended March 31, 2026
Cash and cash equivalents
$229.2 million
As of March 31, 2026
Net cash used in operating activities
$49.1 million
Three months ended March 31, 2026
Total CRO obligations
$88.9 million
Non‑cancellable contractual obligations
Total CMO obligations
$49.5 million
Non‑cancellable contractual obligations
Key Terms
Biologics License Application, epicutaneous immunotherapy, pre-funded warrants, Research Tax Credit, +2 more
6 terms
Biologics License Application regulatory
"our anticipated re-submission of a Biologics License Application (“BLA”) for Viaskin Peanut"
A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.
epicutaneous immunotherapy medical
"based on epicutaneous immunotherapy (“EPIT”), a proprietary method of delivering biologically active compounds"
Epicutaneous immunotherapy is a treatment that delivers tiny, controlled doses of an allergen through a patch applied to the skin to retrain the immune system and reduce allergic reactions over time. Think of it as a slow, measured exposure training the body to tolerate a trigger rather than avoiding it entirely. Investors watch this approach because it represents a potentially safer, easier-to-administer alternative to injections or pills, with implications for market size, regulatory approval, and long-term treatment adoption in allergy therapeutics.
pre-funded warrants financial
"pre-funded warrants to purchase up to 28,276,331 ordinary shares"
Pre-funded warrants are financial instruments that give investors the right to purchase a company's stock at a set price, but with most or all of the purchase price paid upfront. They function like a coupon or gift card for stock, allowing investors to buy shares later at a fixed price, which can be beneficial if they want to avoid future price increases. This makes them important for investors seeking flexibility and certainty in their investment plans.
Research Tax Credit financial
"Research Tax Credit (crédit d’impôt recherche, or CIR) that is granted to companies by the French tax authorities"
A research tax credit is a government incentive that lets companies reduce their tax bill when they spend money on developing new products, processes or technologies. Think of it like a coupon that lowers the cost of costly experiments and innovation; it matters to investors because it improves a company’s cash flow and profitability, can make long-term projects more affordable, and therefore can influence valuation, capital allocation and growth prospects.
Manufacturing Supply Agreement financial
"entered into a Manufacturing Supply Agreement (the “Supply Agreement”) with SANOFI"
going concern financial
"These condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern."
A going concern is a business that is expected to continue its operations and meet its obligations for the foreseeable future, rather than shutting down or selling off assets. This assumption matters to investors because it indicates stability and ongoing profitability, making the business a more reliable investment. Think of it as believing a restaurant will stay open and serve customers, rather than closing down suddenly.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
____________________
FORM 10-Q
____________________
(Mark One)
For the quarterly period ended March 31, 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) | ||||
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 April 30, 2026, the registrant had 296,042,447 ordinary shares, nominal value €0.10 per share, outstanding including treasury shares.
Table of contents
Part I | Financial information | 2 | ||||||
Item 1 | Condensed Consolidated Statements of Financial Position (Unaudited) as of March 31, 2026 and December 31, 2025 | 2 | ||||||
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) for the Three Months Ended March 31, 2026 and 2025 | 3 | |||||||
Condensed Consolidated Statements of Cash Flows (Unaudited) for the Three Months Ended March 31, 2026 and 2025 | 4 | |||||||
Condensed Consolidated Statements of Changes in Shareholders’ Equity (Unaudited) for the Three Months Ended March 31, 2026 and 2025 | 5 | |||||||
Notes to the Condensed Consolidated Financial Statements (Unaudited) | 6 | |||||||
Item 2 | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 15 | ||||||
Item 3 | Quantitative and Qualitative Disclosures About Market Risk | 20 | ||||||
Item 4 | Controls and Procedures | 20 | ||||||
Part II | Other Information | 21 | ||||||
Item 1 | Legal Proceedings | 21 | ||||||
Item 1A | Risk Factors | 21 | ||||||
Item 2 | Unregistered Sales of Equity Securities and Use of Proceeds | 21 | ||||||
Item 3 | Defaults Upon Senior Securities | 22 | ||||||
Item 4 | Mine Safety Disclosures | 22 | ||||||
Item 5 | Other Information | 22 | ||||||
Item 6 | Exhibits | 22 | ||||||
Unless the context otherwise requires, we use the terms “DBV”, “DBV Technologies,” the “Company,” “we,” “us” and “our” in this Quarterly Report on Form 10-Q, or Quarterly Report, to refer to DBV Technologies S.A. and, where appropriate, its consolidated subsidiaries. “Viaskin®” and our other registered and common law trade names, trademarks and service marks are the property of DBV Technologies S.A. or our subsidiaries. All other trademarks, trade names and service marks appearing in this Quarterly Report are the property of their respective owners. Solely for convenience, the trademarks and trade names in this Quarterly Report may be referred to without the ® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert their rights thereto.
SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS
This Quarterly Report contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements may be identified by such forward-looking terminology as “may,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue” or variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Any forward-looking statement involves known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statement. Forward-looking statements include statements, other than statements of historical fact, about, among other things:
•our expectations regarding the timing or likelihood of regulatory filings and approvals, including with respect to our anticipated re-submission of a Biologics License Application (“BLA”) for Viaskin Peanut to the U.S. Food and Drug Administration (“FDA”);
•our expectations with respect to an actionable regulatory pathway, including an Accelerated Approval pathway, for toddlers ages 1-3 years-old for Viaskin Peanut patch;
•our expectations regarding initiation of the confirmatory effectiveness study for Viaskin Peanut patch in 1 - 3 years-old;
•anticipated support for the BLA re-submission for Viaskin Peanut patch to FDA;
•the timing and anticipated results of interactions with regulatory agencies;
•the design, initiation, timing, progress, 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 our product candidates and comply with regulatory requirements related to the manufacturing of our product candidates, if approved;
•our ability to build our own sales and marketing capabilities, or seek collaborative partners, to commercialize Viaskin Peanut and/or our other product candidates, if approved;
•the commercialization of our product candidates, if approved;
•our expectations regarding the potential market size and the size of the patient populations for Viaskin Peanut and/or our other product candidates, if approved, and our ability to serve such markets;
•the pricing and reimbursement of our product candidates, if approved;
•the rate and degree of market acceptance of Viaskin Peanut and/or our other product candidates, if approved, by physicians, patients, third-party payors and others in the medical community;
•our ability to advance product candidates into, and successfully complete, clinical trials;
•the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;
•estimates of our expenses, future revenues, capital requirements and our needs for additional financing;
•the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements;
•our ability to maintain and establish collaborations or obtain additional funding;
•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. 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 | March 31, 2026 | December 31, 2025 | |||||||||||||||
| Assets | |||||||||||||||||
| Current assets : | |||||||||||||||||
| Cash and cash equivalents | 3 | ||||||||||||||||
| Other current assets | 4 | ||||||||||||||||
| Total current assets | |||||||||||||||||
| Property, plant, and equipment, net | |||||||||||||||||
| Right-of-use assets related to operating leases | 5 | ||||||||||||||||
| Intangible assets | |||||||||||||||||
| Other non-current assets | 4 | ||||||||||||||||
| Total non-current assets | |||||||||||||||||
| Total Assets | |||||||||||||||||
| Liabilities and shareholders' equity | |||||||||||||||||
| Current liabilities: | |||||||||||||||||
| Trade payables | 6 | ||||||||||||||||
| Short-term operating leases | 5 | ||||||||||||||||
| Current contingencies & Employee Benefits | 10 | ||||||||||||||||
| Other current liabilities | 6 | ||||||||||||||||
| Total current liabilities | |||||||||||||||||
| Long-term operating leases | 5 | ||||||||||||||||
| Non-current contingencies & Employee Benefits | 10 | ||||||||||||||||
| Total non-current liabilities | |||||||||||||||||
| Total Liabilities | |||||||||||||||||
| Shareholders’ equity : | 7 | ||||||||||||||||
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 March 31, | ||||||||||||||||
| 2026 | 2025 | ||||||||||||||||
| Operating income | 11 | $ | $ | ||||||||||||||
| — | — | ||||||||||||||||
| Operating expenses | 12 | ||||||||||||||||
| 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 on employee benefits, net of taxes | ( | ||||||||||||||||
| Comprehensive loss | $ | ( | $ | ( | |||||||||||||
| Basic/diluted Net loss per share attributable to shareholders | 15 | $ | ( | $ | ( | ||||||||||||
| Weighted average shares outstanding used in computing per share amounts: | 15 | ||||||||||||||||
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 | Three Months Ended March 31, | ||||||||||||||||
| 2026 | 2025 | ||||||||||||||||
| Net loss for the period | $ | ( | $ | ( | |||||||||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||||||||
| Depreciation, amortization and accrued contingencies | 10 | ||||||||||||||||
| Expenses related to share-based payments | 9 | ||||||||||||||||
| Inventory write-downs | |||||||||||||||||
| Other | |||||||||||||||||
| Changes in operating assets and liabilities: | |||||||||||||||||
| Decrease (increase) in inventories and work in progress | ( | ( | |||||||||||||||
| Decrease (increase) in other current assets | 4 | ( | |||||||||||||||
| (Decrease) increase in trade payables | 6 | ( | |||||||||||||||
| (Decrease) increase in other current and non-current liabilities | ( | ( | |||||||||||||||
| Change in operating lease liabilities and right of use assets | 5 | ||||||||||||||||
| Net cash flow used in operating activities | ( | ( | |||||||||||||||
| Cash flows used in investing activities : | |||||||||||||||||
| Change in property, plant, and equipment | ( | ||||||||||||||||
| Change in intangible assets | |||||||||||||||||
| Change in Other non-current assets | 4 | ( | |||||||||||||||
| Net cash flows used in investing activities | ( | ( | |||||||||||||||
| Cash flows provided by financing activities : | |||||||||||||||||
| Treasury shares | ( | ||||||||||||||||
| Issuance from Net Capital increase and Share warrants | 2 | ||||||||||||||||
| 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 | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance at March 31, 2025 | ( | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance at March 31, 2026 | $ | ( | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
5
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”, or “we”, or the “group”) is a late-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin. The Company’s therapeutic approach is based on epicutaneous immunotherapy (“EPIT”), a proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin.
Basis of Presentation
The condensed consolidated financial statements of the Company and its wholly-owned subsidiaries are unaudited and have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) and are presented in U.S. dollars. All significant intercompany accounts and transactions between the Company and its subsidiaries have been eliminated on consolidation.
The unaudited condensed consolidated financial statements presented in this Quarterly Report should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K filed with the SEC on 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. Early adoption is 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.
6
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
•The estimate of provisions and contingencies.
The final amounts may differ from these estimates. Management is also required to exercise judgment in the following areas:
Going concern
These condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business for at least twelve months as of the date of issuance of the financial statements. The Company has incurred operating losses and negative cash flows from operations since inception. The Company does not generate revenue and continues to prepare for the potential launch of its first product in the United States and in the European Union, if approved.
As of March 31, 2026, Cash & Cash Equivalents are $229.2 million. Based on its current operations, plans, and assumptions, Management estimates that the Company is sufficiently funded to run its operations into the second quarter of 2027, and accordingly for at least twelve months from the date of issuance of this Form 10‑Q.
These estimates are based on the Company’s current forecasts and exclude any additional expenditures related to programs other than the Viaskin Peanut or resulting from the potential in licensing or acquisition of additional product candidates or technologies, or any associated development the Company may pursue. The Company may have based these estimates on assumptions that are incorrect, and the Company may end up using its resources sooner than anticipated.
The Company's net cash used in operating activities increased to $49.1 million for the three months ended March 31, 2026, compared to $19.7 million for the three months ended March 31, 2025, reflecting the acceleration of clinical development activities, the build-out of commercial infrastructure, and the continued expansion of the Company's workforce in preparation for a potential U.S. launch of Viaskin Peanut, if approved. The Company expects its operating cash outflows to remain at elevated levels, and potentially increase further, as it advances toward BLA submission, continues to invest in manufacturing readiness and pre-commercial inventory, and scales its commercial organization. This anticipated trajectory of expenditures has been incorporated into the Company's cash runway estimate described above. However, the rate at which the Company utilizes its cash resources may vary materially from current expectations depending on, among other factors, the timing and scope of regulatory interactions, the pace of clinical enrollment, the timing of manufacturing-related capital commitments, and fluctuations in foreign exchange rates. If the Company's operating cash outflows exceed current projections, the Company may need to seek additional financing earlier than anticipated.
The Company may expend resources sooner than anticipated and may seek additional resources to execute the corporate strategy either through new or existing financing strategies.
7
Significant contracts
March 2025 PIPE Financing
March 2025 PIPE Financing
Financing Milestones
On March 27, 2025, the Company announced the 2025 PIPE financing, to advance the VIASKIN Peanut patch through BLA submission and U.S. commercial launch, if approved.
The financing included gross proceeds of $125.5 million (€116.3 million) received on April 7, 2025, and up to $181.4 million (€168.2 million at the exchange rate of 1 EUR = $1.08 ) in potential additional gross proceeds contingent on the full exercise of all the warrants, subject to satisfaction of specified conditions. The terms of the financing provided that the ABSA Warrants and the BS Warrants were exercisable from their respective date of issue until the earlier of (i) April 7, 2027 and (ii) 30 days following the publication by the Company of a press release announcing that the VITESSE trial of the VIASKIN Peanut patch in children aged 4-7 years old met the primary endpoint defined in the VITESSE study protocol (the “VITESSE Topline Reuslts”). It being specified that (i) the primary measure of treatment effect will be the difference in response rates at Month 12 between active and placebo treatment groups, (ii) the primary analysis will be based on a 2-sided confidence interval (“CI”) for the difference in response rates, and (iii) the primary analysis must be positive according to the success criterion (lower bound of the 2- sided 95 % CI of the difference in response rates ≥ 15 %) (the “ABSA Warrant Exercise Period”). Following the announcement of the positive VITESSE Topline Results on December 16, 2025, the ABSA Warrants and BS Warrants were exercisable until January 16, 2026.
On January 16, 2026, the Company announced additional gross proceeds of $195.4 million (€166.7 million at the exchange rate of 1 EUR = $1.17 ), which exceeded the original dollar-equivalent estimate of $181.4 million due to the appreciation of the EURO against the U.S. dollar between the commitment date and the exercise date, resulting from the full exercise of (i) 34,090,004 warrants attached to the ABSA Warrants (as defined below) resulting in the issuance of 59,657,507 new ordinary shares of the Company (as defined below) and (ii) 71,005,656 BS Warrants (as defined below) resulting in the issuance of 71,005,656 Second Pre-Funded Warrants (as defined below), allowing its holders to subscribe for an aggregate of up to 124,259,898 new shares.
Of the total additional gross proceeds of $195.4 million (€166.7 million), $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.
Reminder of the main characteristics of the financing
The exercise of one (1) ABSA Warrant gives the holder the right to subscribe to one point seventy-five (1.75 ) ABSA Warrant Shares at a price of €1.5939 per ABSA Warrant. The financing resulted in an immediate dilution of 22.4 % and a maximal dilution of up to 73.7 % of existing shareholders (on a non-diluted basis) if all the warrants in the Offering are exercised in full. The financing consisted of:
•a share capital increase without preferential subscription rights reserved to categories of persons satisfying determined characteristics pursuant to the 24th resolution of the general meeting of shareholders held on May 16, 2024 (the “2024 General Meeting”) completed on April 7, 2025 for an amount of $41 million (€38 million), consisting of the issuance of (i) 34,090,004 new shares at a par value of €0.10 (the "New Shares") each with warrants of the Company attached (the "ABSA Warrants", and together with the New Shares, the "ABSA") at a subscription price of €1.1136 per ABSA and (ii) up to 59,657,507 additional new shares, if all the ABSA Warrants attached to the New Shares are exercised (the "ABSA Warrant Shares"); and
•the issue through an offering reserved to categories of persons satisfying determined characteristics of 71,005,656 units (the “PFW-BS-PFW”) completed on April 7, 2025 for an amount of $85 million (€79 million) at a subscription price of €1.1136 per PFW-BS-PFW (of which €1.1036 will have been prefunded on the issue date), each PFW-BS-PFW consisting of one pre-funded warrant to subscribe for one share of the Company (the "First Pre-Funded Warrants") and one warrant (the "BS Warrants") to subscribe to one second pre-funded warrants (the "Second Pre-Funded Warrants"), each of which entitles the holder to subscribe for 1.75 shares of the Company (the "Second PFW Shares"), allowing to issue up to 71,005,656 additional new shares if all the First Pre-Funded Warrants are exercised (the "First PFW Shares") and up to 124,259,898 additional new shares if all the Second Pre-Funded Warrants are exercised (the "Second PFW Shares", together with the ABSA Warrant Shares and the First Pre-Funded Warrant Shares, the "Warrant Shares", and together with the New Shares, the "Offered Shares"),(together, the "Offering").
Use of proceeds
The proceeds from the issue of the ABSA Warrants and BS Warrants, together with existing cash and cash equivalents, will be mainly used (i) for working capital and general corporate purposes, (ii) to finance the preparation and submission of a potential Biologics License Application (BLA) as well as (iii) efforts to support, the readiness of the potential launch of VIASKIN® Peanut for children aged 4-7 years in the US, if approved.
Accounting treatment
To properly account for pre-funded warrants under US GAAP, an issuer must first apply ASC 480 – Distinguishing liabilities from equity, and then from ASC 815 – Derivatives and Hedging ASC 480 – DISTINGUISHING LIABILITIES FROM EQUITY
Under ASC 480–10–25, a financial instrument should be classified as liability if:
(i)It is mandatorily redeemable,
(ii)It represents an unconditional obligation to repurchase the issuer’s equity shares,
(iii)It requires the issuer to deliver a variable number of shares or net cash settlement.
In our view, April 2025 prefunded warrants avoid all ASC 480 triggers as they meet the following conditions:
(i)Freestanding and detachable: they are legally separable from other instruments,
(ii)Fixed exercise terms: they entitle the holder to a fixed number of shares upon exercise,
(iii)No redemption obligations: they do not require the issuer to transfer cash to repurchase shares.
ASC 815 – DERIVATIVES AND HEDGING
ASC 815 – 40 – Contracts in Entity’s Own Equity addresses whether an equity-linked contract, qualifies as equity in the entity’s financial statements. Indexation to the Company’s own stock. The first condition that must be met for an equity-linked instrument to qualify as equity is to be considered indexed to the entity’s own stock in accordance with ASC 815-40-15. To determine whether an equity-linked instrument is indexed to the Entity’s own stock, a 2-step analysis must be performed:
8
•Step 1 – Evaluate whether the instrument contains any exercise contingencies, and, if so, whether they disqualify the instrument from being classified as equity,
•Step 2 – Assess whether the settlement terms are consistent with equity classification.
Based on the above elements Prefunded warrants are to be indexed to the Company’s stock.
Equity classification
As Pre-Funded warrants require a settlement in shares (physical settlement) and neither give rise to a net-cash settlement nor provide the option of settlement in shares or net cash settlement, they shall be initially classified as equity. Other conditions necessary for equity classification are met:
•The Company has sufficient authorized and unissued shares available to settle the contract after considering all other commitments that may require the issuance of stock during the maximum period the Pre-Funded warrants could remain outstanding.
•The contract contains an explicit limit on the number of shares (1 share per First Pre-Funded warrant and up to 71,005,656 in total and 1.75 share per Second Prefunded warrant and up to 124,259,898 in total) to be delivered in a share settlement. Adjustments to the exercise ratio are subject to the occurrence of specific events and result from the application of determined formulas.
•There is no required cash payment if DBV Technologies S.A. fails to timely file. There is no requirement to net cash settle the contract in the event the entity fails to make timely filings with the SEC or to maintain registration.
•There are no cash settled top-off or make-whole provisions. April 2025 Prefunded warrants can be classified as equity and shall be accounted for in permanent equity. Subsequent changes in fair value shall not be recognized as long as they continue to be classified as equity.
Upon exercise of the pre-funded warrants, the Company issued common shares in accordance with the terms of the warrants. The accounting treatment for the exercise is as follows:
•The par value of the newly issued common shares is recorded in ‘Common stock’. Any additional amount, including the exercise price paid and the remaining carrying amount of the warrants is 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.
•The Company updated its share count and equity roll-forward to reflect the issuance of shares.
Manufacturing Supply Agreement - Peanut Source Material - Fareva La Vallée
On March 17, 2026, DBV Technologies S.A. entered into a MS Agreement (the “MS Agreement”) with Fareva La Vallee (“FLV”), under which FLV will manufacture and supply the Viaskin peanut source material (“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.
This MS Agreement is subsequent to the 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 services include (i) construction activities, (ii) the acquisition equipment, and (iii) the cGMP qualification of a dedicated PSM production line installed at FLV’s premises. DBV has funded capital expenditures amounting to $3.9 million, granting access to preferential pricing and to an exclusively dedicated PSM production line located at FLV’s facilities, while ownership of the line remains with FLV. The assessment of the Manufacturing Supply Agreement concludes that the arrangement contains an embedded lease within the scope of ASC 842 (Leases), based on the following criteria:
–Identified asset: The dedicated PSM production line represents an identified asset, and the supplier 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 asset will be recognized at the lease commencement date, defined as the date on which the production line is made available for use following completion of cGMP qualification. At this stage, the Company has identified the embedded lease, the separation of lease and non‑lease components of the arrangement, and the reclassification of the payment related to the exclusive access right as prepaid rent under ASC 842 (Other non-current assets).
The Company has non-cancellable minimum commitments for PSM, subject to the terms of the Manufacturing Supply Agreement. At the end of a 36-month period starting from the first commercial batch delivery, if the Company has not ordered any batches, excluding technical and validation batches, the Company shall pay FLV an amount not to exceed $0.6 million. As of March 31, 2026, DBV intends to meet the purchase obligations and therefore did not record any liability or accrual related to these commitments
9
Note 2 Significant Events and Transactions
March 2025 PIPE Financing
Refer to Note 1 above for additional details regarding the March 2025 PIPE Financing.
Manufacturing Supply Agreement - Peanut Source Material - Fareva La Vallée
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.
Legal Proceedings
Note 3 Cash and Cash Equivalents
The following tables summarize the cash and cash equivalents as of March 31, 2026 and December 31, 2025:
| March 31, 2026 | December 31, 2025 | ||||||||||
| Cash | |||||||||||
| Cash Equivalents | |||||||||||
| Total Cash and Cash Equivalents | |||||||||||
Cash equivalents are convertible into cash on 32 days notice at no or insignificant cost, on demand. They are measured using level 1 fair value measurements.
Note 4 Other Current & Non Current Assets
Other current assets consisted of the following:
| March 31, 2026 | December 31, 2025 | ||||||||||
Research tax credit | |||||||||||
VAT Assets | |||||||||||
Prepaid expenses | |||||||||||
Other receivables | |||||||||||
| Total | |||||||||||
The VAT (Value Added Taxes) Assets related to deductible VAT paid on purchases. Prepaid expenses are comprised of finance, legal as well as scientific consulting fees and insurance expenses. Prepaid expenses also include upfront payments which are recognized over the term of the ongoing clinical studies.
Other non Current Assets mainly include $3.9 million the prepaid rent of the dedicated PSM production line located at Fareva La Vallée’s facilities. The right‑of‑use asset will be recognized when the production line is made available for use following completion of cGMP qualification.
Research tax credit
The variance in Research Tax Credit is presented as follows:
| 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 March 31, 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.
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Note 5 Lease contracts
Future minimum lease payments under the Company’s operating leases’ right of use as of March 31, 2026 and December 31, 2025, are as follows:
| March 31, 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 | |||||||||||||||||||||||||||||||||||
The Company recognizes rent expense, calculated as the remaining cost of the lease allocated over the remaining lease term on a straight-line basis. Rent expense presented in the consolidated statement of operations and comprehensive loss was:
| March 31, | |||||||||||
| 2026 | 2025 | ||||||||||
Operating lease expense / (income) | |||||||||||
Note 6 Trade Payables and Other Current Liabilities
Trade Payables
Trade payables decreased by $1.4 million as of March 31, 2026, compared to December 31, 2025.
Other Current Liabilities
The following tables summarize the other liabilities as of March 31, 2026 and December 31, 2025:
The decrease in social debt compared to the prior period primarily reflects the timing of bonus payments and the settlement of payroll-related liabilities accrued as of December 31, 2025, partially offset by the continued expansion of the Company's teams and the corresponding increase in social security and payroll tax contributions.
| March 31, 2026 | December 31, 2025 | ||||||||||
| Social debt | |||||||||||
| Tax liabilities | |||||||||||
| Other debts | |||||||||||
| Total | |||||||||||
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Note 7 Shareholders’ equity
The share capital as of March 31, 2026 is set at the sum of €29,604,245 ($33,959,486.35 converted at historical rates). It is divided into 296,042,447 fully authorized, subscribed and paid-up ordinary shares with a par value of €0.10 .
The table below presents the changes in the share capital of the Company as of March 31, 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 RFW 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 warrants | |||||||||||||
| 14/01/2026 | Capital increase by ordinary shares | ( | ||||||||||||
| 16/01/2026 | Capital increase by employee warrants | |||||||||||||
| 22/01/2026 | Capital increase by ordinary shares | ( | ||||||||||||
| 22/01/2026 | Capital increase by ordinary shares | |||||||||||||
| 29/01/2026 | Capital increase by employee warrants | |||||||||||||
| 13/02/2026 | Capital increase by ordinary shares | ( | ||||||||||||
| 11/03/2026 | Capital increase by ordinary shares | ( | ||||||||||||
| 31/03/2026 | Share base payment accrual | |||||||||||||
| 31/03/2026 | Issuance of warrants | |||||||||||||
Total Equity Balance as of March 31, 2026 | ||||||||||||||
Note 8 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 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, which increases volatility and uncertainty regarding foreign‑currency‑denominated operating costs.
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 March 31, 2026.
The Company’s policy is not to enter into derivative transactions for speculative purposes.
| (In Million of dollars) | As of March 31, 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
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Note 9 Share-Based Payments
The Board of Directors has been authorized at the General Meeting of the Shareholders to grant restricted stock units (“RSU”), stock options plan (“SO”), and non-employee warrants (Bons de Souscription d’Actions or “BSA”).
During the three months ended March 31, 2026, the Company granted stock options and restricted stock units to employees as described below.
There have been no changes in the vesting conditions and method of valuation of the SO and RSUs from that disclosed in Note 11 to the consolidated financial statements included in the Annual Report.
Change in Number of BSA/SO/RSU:
| Number of outstanding | |||||||||||||||||
| BSA | SO | RSUs | |||||||||||||||
Balance as of December 31, 2025 | |||||||||||||||||
| Granted during the period | |||||||||||||||||
| Forfeited during the period | ( | ||||||||||||||||
| Exercised/released during the period | ( | ||||||||||||||||
Balance as of March 31, 2026 | |||||||||||||||||
Share-based payments expense reflected in the condensed consolidated statements of operations is as follows:
| Three Months Ended March 31, | |||||||||||||||||||||||||||||
| 2026 | 2025 | ||||||||||||||||||||||||||||
| Research & development | SO | ( | ( | ||||||||||||||||||||||||||
| RSU | ( | ( | |||||||||||||||||||||||||||
| Sales & marketing | SO | ( | |||||||||||||||||||||||||||
| RSU | |||||||||||||||||||||||||||||
| General & administrative | SO | ( | ( | ||||||||||||||||||||||||||
| RSU | ( | ( | |||||||||||||||||||||||||||
| ( | ( | ||||||||||||||||||||||||||||
Note 10 Contingencies & Employee Benefits
The following tables summarize the contingencies as of March 31, 2026 and December 31, 2025:
| March 31, 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 | — | ||||||||||||||||
| Reversals of unused liabilities | — | — | — | ||||||||||||||
| Actuarial gains and losses on defined-benefit plans | — | ||||||||||||||||
| Currency translation effect | — | — | — | ||||||||||||||
| At March 31, 2026 | |||||||||||||||||
| Of which current | |||||||||||||||||
| Of which non-current | |||||||||||||||||
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Note 11 Operating income
The following table summarizes the operating income during the three months ended March 31, 2026 and 2025:
| Three Months Ended March 31, | |||||||||||||||||||||||
| 2026 | 2025 | ||||||||||||||||||||||
| Research tax credit | |||||||||||||||||||||||
| Other operating income | |||||||||||||||||||||||
| Total | |||||||||||||||||||||||
Note 12 Operating expenses and Allocation of Personnel Expenses
The Company had an average of 161 employees during the three months ended March 31, 2026, in comparison with an average of 106 employees during the three months ended March 31, 2025. The increase is mainly due to hiring to support development activities and quality activities.
The following table summarizes the allocation of personnel expenses by function during the three months ended March 31, 2026 and 2025:
| Three Months Ended March 31, | |||||||||||||||||||||||
| 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 three months ended March 31, 2026 and 2025:
| Three Months Ended March 31, | |||||||||||||||||||||||
| 2026 | 2025 | ||||||||||||||||||||||
| Wages and salaries | |||||||||||||||||||||||
| Social security contributions | |||||||||||||||||||||||
| Expenses for pension commitments | |||||||||||||||||||||||
| Share-based payments | |||||||||||||||||||||||
| Total | |||||||||||||||||||||||
The first quarter of 2025 remained at a more measured pace, as the Company was awaiting the agreement with the U.S. Food and Drug Administration, reached on March 24, 2025, regarding the safety data required to support the Biologics License Application (BLA) for the Viaskin® Peanut patch in children aged 4 to 7, if approved. Following this regulatory milestone, the completion of the March 2025 PIPE financing enabled the Company to accelerate progress toward its next development and regulatory milestones.
14
Note 13 Commitments
In connection with the launch of our clinical trials, we have entered into service agreements with several CROs. For the three months ended March 31, 2026, expenses associated with the ongoing trials amounted globally to $7.4 million, and we had non-cancellable contractual obligations with CROs amounting to $88.9 million.
The Company has entered into multi‑year supply and manufacturing agreements that include minimum purchase obligations over defined periods. Under applicable accounting guidance, take‑or‑pay commitments are generally considered firm purchase commitments but remain off‑balance sheet unless they create an unavoidable or unconditional payment obligation, or become loss contract.
With Sanofi
On August 29, 2025, the Company entered into a Manufacturing Supply Agreement (the “Supply Agreement”) with SANOFI under which SANOFI will manufacture and supply the Viaskin Peanut API exclusively for DBV Technologies S.A. during the agreement term. The Supply Agreement has an effective date of January 1, 2025 and an initial term of four (4 ) years with a possibility to extend for an additional period. Under the Supply Agreement, the Company has agreed to certain minimum purchase levels and service fees over the initial 4 -year-term.
As of March 31, 2026, total payments made during the period under the Supply Agreement were approximately $1.6 million, which were recorded as R&D expenses. The Company will expense manufacturing and supply costs as incurred.
With Fareva
On March 17, 2026, DBV Technologies S.A. entered into the MS Agreement with FLV, under which FLV will manufacture and supply 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 .
For the three months ended March 31, 2026, total payments made during the period under the MS Agreement are approximately $0.1 million.
The following table presents our material expenses commitments for future periods:
| 2026 | 2027 | 2028 | Thereafter | Total | |||||||||||||
(Amounts in million) | |||||||||||||||||
Purchase obligations - Obligations Under the Terms of CRO Agreements | |||||||||||||||||
Purchase obligations - Obligations Under the Terms of CMO Agreements | |||||||||||||||||
| Total | |||||||||||||||||
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 14 Relationships with Related Parties
There were no new significant related-party transactions during the period nor any changes in the nature of the transactions from those described in Note 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 $1.8 million. The recipients of this compensation are “related parties”.
| March 31, 2026 | March 31, 2025 | |||||||
Short-term benefits | ||||||||
| Post-employment benefits | ||||||||
| Total | ||||||||
The methods for the valuation of the benefit related to share-based payments are presented in Note 9 Share-Based Payments.
Amounts payable to related parties as of March 31, 2026 and December 31, 2025 are as follows:
| March 31, 2026 | December 31, 2025 | |||||||
Compensation | ||||||||
Pension obligations | ||||||||
| Total | ||||||||
The parent company, DBV Technologies S.A., entered into a cash‑pooling agreement with its subsidiaries (DBV Technologies Inc., DBV Technologies Australia Pty Ltd and DBV Pharma SAS), the balance of which amounts to the following:
| March 31, 2026 | December 31, 2025 | |||||||
Loans & Advances | ||||||||
| Total | ||||||||
15
Note 15 Loss Per Share
The Basic loss per share is calculated by dividing net loss attributable to the Company’s shareholders by the weighted‑average number of ordinary shares outstanding during the period. Following the March 2025 PIPE financing, this weighted‑average share count includes the shares underlying the pre‑funded warrants, as the remaining cash exercise price for those warrants is considered immaterial.
The computations for basic and diluted loss per share were as follows (in millions of U.S. Dollars except share and per share data):
| March 31, 2026 | March 31, 2025 | |||||||
| Net loss | ( | ( | ||||||
| Weighted average number of ordinary shares | ||||||||
| Net loss per share attributable to ordinary shareholders, basic and diluted ($/share) | ( | ( | ||||||
This summary also gives an overview of all exercisable instruments generated by the company either through Financing or incentive programs for employees as described in Note 9.
| March 31, 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 16 Reportable segment disclosure
| Three Months Ended March 31, | |||||||||||
| 2026 | 2025 | ||||||||||
| Clinical studies | |||||||||||
| BLA & Regulatory | |||||||||||
| Medical Affairs & Other Medical | |||||||||||
| Research & Innovation | |||||||||||
| Manufacturing & Supply and Quality | |||||||||||
| Sales & Marketing | |||||||||||
| General & Administrative | |||||||||||
| Total expenses | |||||||||||
The Company operates and is managed as one
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 17 Events after the Close of the Period
The Company has evaluated subsequent events through the date these condensed consolidated financial statements were issued and determined that there were no subsequent events requiring disclosure or adjustment.
16
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 EPIT, our proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin, an epicutaneous patch (i.e., a skin patch). We have generated significant data demonstrating that Viaskin’s mechanism of action is novel and differentiated. Viaskin targets specific antigen-presenting immune cells in the skin, called Langerhans cells, that capture the antigen and migrate to the lymph node 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, which has been evaluated as a potential therapy for children with peanut allergy in twelve clinical trials, including three Phase 2 trials and four completed Phase 3 trials. We have two ongoing Phase 3 trials of Viaskin Peanut in children ages one to three and ages four to seven with peanut allergy. The Company plans to submit a BLA for Viaskin Peanut in children aged 4 to 7 in the first half of 2026. With respect to the toddler program, the COMFORT Toddlers supplemental safety study in peanut allergic children aged 1 to 3, which screened its first subject on June 25, 2025, is ongoing and the Company continues to enroll subjects towards its target of approximately 300 to 350 subjects on active treatment. This would bring the total Viaskin Peanut patch safety database in this age group to approximately 600 subjects, consistent with prior FDA guidance.
Overview of the First Quarter of 2026
In the first quarter of 2026, the Company started to execute its plan for the potential U.S. commercialization of the Viaskin Peanut patch for children aged 4 to 7, following regulatory, clinical and financial developments in 2025 that will support a BLA filing and have increased cash and cash equivalents.
In March 2025, the FDA confirmed the safety data requirements to support the planned Biologics License Application for Viaskin Peanut in children aged 4 to 7 if approved, providing a clear and executable path toward submission. Subsequently, the Company completed its March 2025 PIPE financing. In addition ATM sales in the second half of 2025 materially strengthened the Company’s balance sheet, enabling continued progression toward potential commercialization while maintaining disciplined capital allocation. Finally, in December 2025, the Company reported positive topline results from the Phase 3 VITESSE trial in peanut-allergic children aged 4 to 7 years that enable a BLA filing expected in the first half of 2026.
The Company’s strategic objective remains to change the field of immunotherapy by developing and commercializing safe, effective, and convenient therapies for patients with food allergies and other immunological conditions while delivering sustained value to shareholders.
Critical Accounting Policies and Significant Judgments and Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”). The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements, as well as the revenue, costs and expenses recognized during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
There have been no new policies or significant changes to our critical accounting policies as disclosed in the critical accounting policies described in the Annual Report. Our significant accounting policies are more fully described in Note 1 of the Notes to the Consolidated Financial Statements in Part I, Item 1 of our Annual Report.
17
Business Trends and Results of Operations
Comparison of the Three Months Ended March 31, 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 March 31, 2026 and 2025.
| Three Months Ended March 31, | |||||||||||||||||||||||
| 2026 | 2025 | $ change | % of change | ||||||||||||||||||||
| Operating income | 0.9 | 0.8 | 0.1 | 15% | |||||||||||||||||||
| Operating expenses | |||||||||||||||||||||||
| Research and development expenses | (33.4) | (21.5) | (11.9) | 55% | |||||||||||||||||||
| Sales and marketing expenses | (4.8) | (0.3) | (4.6) | 1750% | |||||||||||||||||||
| General and administrative expenses | (10.5) | (5.6) | (4.9) | 87% | |||||||||||||||||||
| Total Operating expenses | (48.8) | (27.4) | (21.4) | 78% | |||||||||||||||||||
| Financial income (expense) | 0.5 | (0.5) | 1.0 | (215)% | |||||||||||||||||||
| Income tax | (0.2) | — | (0.2) | —% | |||||||||||||||||||
| Net loss | (47.6) | (27.1) | (20.5) | 76% | |||||||||||||||||||
Operating Income
The following table summarizes our operating income during the three months ended March 31, 2026 and 2025:
| Three Months Ended March 31, | |||||||||||||||||||||||
| 2026 | 2025 | $ change | |||||||||||||||||||||
| Research tax credit | 0.9 | 0.8 | 0.1 | 15% | |||||||||||||||||||
Total Other operating income | 0.9 | 0.8 | 0.1 | 15% | |||||||||||||||||||
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 $0.9 million as of March 31, 2026. This level in tax credit income accrual reflects on a full year basis the expected lower level 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 three months ended March 31, 2026 and 2025:
| Three Months Ended March 31, | |||||||||||||||||||||||
| 2026 | 2025 | $ change | % of change | ||||||||||||||||||||
| External clinical-related expenses | 19.7 | 9.7 | 10.0 | 104% | |||||||||||||||||||
| Employee-related costs | 7.4 | 4.1 | 3.3 | 82% | |||||||||||||||||||
| Share-based payment expenses | 1.1 | 0.6 | 0.5 | 86% | |||||||||||||||||||
| Depreciation, amortization and other costs | 2.2 | 2.9 | (0.7) | (24)% | |||||||||||||||||||
| Pre-Commercial Inventory | 3.0 | 4.3 | (1.3) | (29)% | |||||||||||||||||||
| Total Research and Development expenses | 33.4 | 21.5 | 11.9 | 55% | |||||||||||||||||||
External clinical-related expenses increased by $10.0 million for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 mainly due to higher clinical trial activity driven by the initiation of patient recruitment for the COMFORT Toddlers study, and to the acceleration of BLA readiness activities to prepare BLA submission.
Employee-related costs and share based payment expenses respectively increased by $3.3 million and $0.5 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025 primarily due to reinforcement of Medical Affairs, Quality and Regulatory functions in the United States to support a potential U.S. launch, if approved, and to ensure organizational readiness as the Company approaches commercialization.
The Company continued its precommercial inventory build up for $3.0 million in anticipation of potential FDA approval.
Depreciation, amortization and other costs decreased by $0.7 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025 primarily due to lower depreciation and amortization. Other costs reduced as well in the absence of certain prior-year charges.
18
Sales and Marketing Expenses
The following table summarizes our sales and marketing expenses incurred during the three months ended March 31, 2026 and 2025:
| Three Months Ended March 31, | |||||||||||||||||||||||
| 2026 | 2025 | $ change | % of change | ||||||||||||||||||||
| External professional services | 3.6 | 0.1 | 3.5 | 3373% | |||||||||||||||||||
| Employee-related costs | 0.9 | 0.1 | 0.7 | 546% | |||||||||||||||||||
| Share-based payment expenses | 0.1 | — | 0.1 | 555% | |||||||||||||||||||
| Depreciation, amortization and other costs | 0.2 | — | 0.2 | 10629% | |||||||||||||||||||
| Total Sales & Marketing expenses | 4.8 | 0.3 | 4.6 | 1750% | |||||||||||||||||||
Sales and marketing expenses have increased by $4.6 million during the three months ended March 31, 2026, compared to the three months ended March 31, 2025 reflecting the Company’s go‑to‑market strategy.
In the third quarter of 2025, the Company appointed a Chief Commercial Officer, marking a key step in establishing a dedicated commercial organization. Since then, efforts have focused on building U.S.‑based commercial, market access and launch‑readiness capabilities designed to support a successful introduction of Viaskin® Peanut in children aged 4 to 7, if approved. The increase in sales and marketing expenses in the first quarter of 2026 reflects the continued build‑out of this commercial infrastructure and the progression toward execution of this strategy.
General and Administrative Expenses
The following table summarizes our general and administrative expenses incurred during the three months ended March 31, 2026 and 2025:
| General & Administrative expenses | Three Months Ended March 31, | ||||||||||||||||||||||
| 2026 | 2025 | $ change | % of change | ||||||||||||||||||||
| External professional services | 4.2 | 1.1 | 3.1 | 295% | |||||||||||||||||||
| Employee-related costs | 3.5 | 1.9 | 1.6 | 83% | |||||||||||||||||||
| Share-based payment expenses | 1.1 | 1.1 | -0.0 | (1)% | |||||||||||||||||||
| Depreciation, amortization and other costs | 1.8 | 1.6 | 0.3 | 16% | |||||||||||||||||||
| Total General & Administrative expenses | 10.5 | 5.6 | 4.9 | 87% | |||||||||||||||||||
General and Administrative expenses increased by $4.9 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025.
External professional services increased by $3.1 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025 primarily due to an accelerated activity in 2026 to support a potential U.S. launch, if approved, and to ensure organizational readiness as the Company approaches commercialization particularly through Investor Relations, Human Resources and Legal activities. This increase in activity is further accentuated given that, in the prior-year period, the Company was containing its costs and expenses during its financing period ended in March 31, 2025.
Employee-related costs and share-based payments increased by $1.6 million, for the three months ended March 31, 2026, compared to the three months ended March 31, 2025 as the Company continued to scale its organization in preparation for commercial operations. The growth in full time employees was concentrated in Human Resources, Information Solutions, Finance, and Legal and Compliance, reflecting targeted investments in the core infrastructure required to achieve commercial readiness for Viaskin Peanut in North America. These additions were designed to strengthen operational capabilities, enhance organizational maturity, and support the transition toward a potential commercial launch, if approved.
Depreciation, amortization and other costs increased by $0.3 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025.
Financial Income (Expense)
Our financial income was $0.5 million for the three months ended March 31, 2026, compared to a financial expense of $0.5 million for the three months ended March 31, 2025. This item mainly includes the interest income on our short term investments.
Income Tax
Our income tax expense was $0.2 million for the three months ended March 31, 2026 compared to nil for the three months ended March 31, 2025. The income tax expense for the current period relates to the Company’s U.S. subsidiary, which generated taxable income pursuant to the Company’s intercompany transfer pricing arrangements.
Net Loss
Net loss was $47.6 million for the three months ended March 31, 2026, compared to $27.1 million for the three months ended March 31, 2025. Net loss per share (based on the weighted average number of shares outstanding over the period) decreased from $(0.26) to $(0.11) for the three months ended March 31, 2025 and March 31, 2026, respectively.
19
Liquidity and Capital Resources
Our financing strategy is to maintain financial flexibility to meet working capital requirements including commercial inventory build and manufacturing capacity expansion to support demand of VIASKIN Peanut patches in the United States and Europe, if approved.
Financial Condition
On March 31, 2026, the Company held $229.2 million in cash and cash equivalents compared to $194.2 million of cash and cash equivalents on December 31, 2025. Net cash used for operating activities was $49.1 million and $19.7 million for the periods ended March 31, 2026 and March 31, 2025, respectively. The Company’s net cash flows provided by financing activities totaled $88.9 million for the periods ended March 31, 2026 and nil in March 31, 2025, following the full Exercise of the ABSA Warrants and BS Warrants Issued on its March 2025 PIPE Financing.
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, and a significant portion of its operating expenses, including personnel costs and facility-related expenditures, are denominated in euros. During the three months ended March 31, 2026, the euro depreciated against the U.S. dollar, resulting in a $(4.4) million unfavorable foreign currency translation adjustment recognized in other comprehensive loss and a $(4.5) million unfavorable effect of exchange rate changes on cash and cash equivalents. As the Company continues to expand its U.S.-based operations in preparation for a potential commercial launch, an increasing proportion of its expenditures are denominated in U.S. dollars; however, the Company's euro-denominated cost base remains substantial. Continued appreciation of the euro against the U.S. dollar would increase the U.S. dollar equivalent of the Company's euro-denominated operating expenses and could accelerate the utilization of the Company's cash resources, which are held primarily in U.S. dollars. The Company utilizes foreign exchange swap instruments to manage a portion of this exposure, as described in Note 8 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 up to March 31, 2026, the Company has received a total of approximately $1.7 billion in equity financing, almost all of which relates to cash proceeds from capital increases. The Company obtained the following gross proceeds from various financings through the issuance of securities as detailed :
| In Million dollars | Equity capital | Bank loan | Other debt | Total | ||||||||||
| Before 2023 | 1,309.7 | 1,309.7 | ||||||||||||
| 2023 | 7.8 | 7.8 | ||||||||||||
| 2025 | 291.5 | 291.5 | ||||||||||||
| 2026 | 94.7 | 94.7 | ||||||||||||
| Total | 1,703.7 | 1,703.7 | ||||||||||||
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 April 2025, the Company completed a PIPE financing generating initial gross proceeds of $125.5 million (€116.3 million), followed by the full exercise of associated warrants in January 2026 after the announcement of positive Phase 3 VITESSE topline results, resulting in additional gross proceeds of $195.4 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 addition, in September 2025, the Company established an ATM equity program pursuant to which it may offer and sell up to $150.0 million of ADSs, subject to applicable regulatory limits. During the fourth quarter of 2025, the Company raised $65 million in gross proceeds through multiple issuances of ADSs.
The Company also benefits as an SME status from refunds of Research Tax credit (crédit d’impôt recherche) granted to companies by the French tax authorities in order to encourage them to conduct technical and scientific research.
Material expenses commitments
The following table presents our material expenses commitments for future periods:
| Material Cash Requirements Due by | |||||||||||||||||
| 2026 | 2027 | 2028 | Thereafter | Total | |||||||||||||
(Amounts in million) | |||||||||||||||||
Operating leases | 1.3 | 1.0 | 1.0 | 3.9 | 7.1 | ||||||||||||
Purchase obligations - Obligations Under the Terms of CRO Agreements | 37.1 | 25.2 | 20.1 | 6.5 | 88.9 | ||||||||||||
Purchase obligations - Obligations Under the Terms of CMO Agreements | 17.7 | 15.9 | 15.9 | — | 49.5 | ||||||||||||
| Total | 56.1 | 42.1 | 37.0 | 10.4 | 145.5 | ||||||||||||
The commitment amounts in the table above are associated with contracts that are enforceable and legally binding and that specify all significant terms, including fixed or minimum services to be used, fixed, minimum or variable price provisions, and the approximate timing of the actions under the contracts. Future events could cause actual payments to differ from these estimates.
20
Forward-looking
As of March 31, 2026, Cash & Cash Equivalents are $229.2 million. Based on its current operations, plans, and assumptions, Management estimates that the Company is sufficiently funded to run its operations into the second quarter of 2027.
These estimates are based on the Company’s current forecasts and exclude any additional expenditures related to programs other than the VIASKIN Peanut or resulting from the potential in licensing or acquisition of additional product candidates or technologies, or any associated development the Company may pursue. The Company may have based these estimates on assumptions that are incorrect, and the Company may end up using its resources sooner than anticipated.
The Company's net cash used in operating activities increased to $49.1 million for the three months ended March 31, 2026, compared to $19.7 million for the three months ended March 31, 2025, reflecting the acceleration of clinical development activities, the build-out of commercial infrastructure, and the continued expansion of the Company's workforce in preparation for a potential U.S. launch of Viaskin Peanut, if approved. The Company expects its operating cash outflows to remain at elevated levels, and potentially increase further, as it advances toward BLA submission, continues to invest in manufacturing readiness and pre-commercial inventory, and scales its commercial organization. This anticipated trajectory of expenditures has been incorporated into the Company's cash runway estimate described above. However, the rate at which the Company utilizes its cash resources may vary materially from current expectations depending on, among other factors, the timing and scope of regulatory interactions, the pace of clinical enrollment, the timing of manufacturing-related capital commitments, and fluctuations in foreign exchange rates. If the Company's operating cash outflows exceed current projections, the Company may need to seek additional financing earlier than anticipated.
The Company may expend resources sooner than anticipated and may seek additional resources to execute the corporate strategy either through new or existing financing strategies. As of date of issuance, the remaining financing capacity and Equity securities are:
Remaining financing capacity and Equity securities | Warrants | Strike price | Total Amount available | ||||||||
2025 ATM Program | 85.0 | ||||||||||
PFW1 from PFW-BS-PFW (2025 PIPE) | 32,267,060 | 0.01 | 0.32 | ||||||||
PFW2 (2025 PIPE) | 55,579,360 | 0.02 | 1.11 | ||||||||
PFW 2022 | 13,116,331 | 0.12 | 1.57 | ||||||||
| Total | 100,962,751 | 88.0 | |||||||||
Smaller Reporting Company Status
We are a smaller reporting company as defined in the Securities Exchange Act of 1934, as amended. We may, and intend to, take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as we are a smaller reporting company. We may be a smaller reporting company in any year in which (i) the market value of our voting and non-voting ordinary shares held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter or (ii) (a) our annual revenue is less than $100.0 million during the most recently completed fiscal year and (b) the market value of our voting and non-voting ordinary shares held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.
21
Item 3. Quantitative and Qualitative Disclosures About Market Risk
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
Based on its evaluation as of March 31, 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 of fraud may occur and not be detected.
22
PART II – OTHER INFORMATION
Item 1. Legal Proceedings
See “Note 2: Significant Events and Transactions – Legal Proceedings” in the notes to the condensed consolidated financial statements included elsewhere in this Quarterly Report.
Item 1A. Risk Factors
Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and trading price of our securities. In addition to the other information set forth in this Quarterly Report, you should carefully consider the factors described in Part I, Item 1A. “Risk Factors” of our Annual Report. While management has plans to address these issues, there is no assurance these plans will be successful, which could materially impact our business and financial condition.
Item 2. Defaults Upon Senior Securities
None.
Item 3. Mine Safety Disclosures
Not applicable.
Item 4. Other Information
During the three months ended March 31,2026, none
Item 5. Exhibits
Exhibit Index
| Exhibit | Description | Incorporated by Reference | |||||||||||||||
| Schedule/ Form | File Number | Exhibit | File Date | ||||||||||||||
3.1 | By-laws (status) of the registrant (English translation) | Form 10-K | 001-36697 | 3.1 | March 26,2026 | ||||||||||||
31.1 | Certificate of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended | ||||||||||||||||
31.2 | Certificate of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended | ||||||||||||||||
32.1* | Certificate of 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, as amended | ||||||||||||||||
101.INS | XBRL Instance Document | ||||||||||||||||
101.SCH | XBRL Taxonomy Extension Schema Document | ||||||||||||||||
101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document | ||||||||||||||||
101.DEF | XBRL Taxonomy Extension Definition Linkbase Document | ||||||||||||||||
101.LAB | XBRL Taxonomy Extension Labels Linkbase Document | ||||||||||||||||
101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document | ||||||||||||||||
104 | Cover Page Interactive Data File, formatted in Inline XBRL and contained in Exhibit 101. | ||||||||||||||||
*Furnished herewith and not deemed to be “filed” for purposes of Section 18 of the Exchange Act, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Form 10-Q), irrespective of any general incorporate language contained in such filing. | |||||||||||||||||
23
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: April 30, 2026 | By: | /s/ Daniel Tassé | ||||||
Daniel Tassé | ||||||||
Chief Executive Officer | ||||||||
(Principal Executive Officer) | ||||||||
Date: April 30, 2026 | By: | /s/ Virginie Boucinha | ||||||
Virginie Boucinha | ||||||||
Chief Financial Officer | ||||||||
(Principal Financial and Accounting Officer) | ||||||||
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