DBV Technologies (NASDAQ: DBVT) posts $98M loss, holds $174.9M cash
DBV Technologies S.A. is a late-stage biopharmaceutical company developing the Viaskin epicutaneous patch platform, led by Viaskin Peanut for children with peanut allergy. For the quarter ended June 30, 2026, there was no product revenue; operating income of $0.7 million came solely from the French research tax credit.
Quarterly operating expenses were $51.3 million, including research and development of $31.2 million, sales and marketing of $5.5 million, and general and administrative of $14.6 million, reflecting scaling for Biologics License Application (BLA) execution and commercial launch preparedness. Net loss was $50.4 million for the quarter and $98.0 million for the first six months, with basic and diluted loss per share of $(0.12) and $(0.23), respectively.
Cash and cash equivalents totaled $174.9 million at June 30, 2026. Net cash used in operating activities was $101.7 million and in investing activities $0.9 million in the first half, partially offset by $89.0 million of financing inflows from warrant exercises linked to the March 2025 PIPE financing. Management estimates existing resources will fund operations into the third quarter of 2027. The company is preparing a BLA for Viaskin Peanut in children aged 4–7 years in the third quarter of 2026 and a potential toddler BLA in the second half of 2026, supported by expanded manufacturing agreements and commercialization letters of intent.
Positive
- Cash and cash equivalents of $174.9 million at June 30, 2026, together with management’s estimate of funding into the third quarter of 2027, provide liquidity through planned Viaskin Peanut BLA submissions and early commercialization preparations.
- Exercise of warrants from the March 2025 PIPE generated additional gross proceeds of $94.7 million in January 2026, contributing to total equity financing of $1.7 billion since inception and strengthening the capital base.
Negative
- Net loss of $98.0 million for the first half of 2026 and net cash used in operating activities of $101.7 million reflect materially higher spending, with total operating expenses rising 43% year over year.
- The company remains pre-revenue, with operating income of only $1.6 million in the first half of 2026 coming entirely from research tax credits, underscoring reliance on external financing to support ongoing development and commercialization activities.
Key Figures
Cash and cash equivalents: $174.9 million
Net loss Q2 2026: $50.4 million
Net loss H1 2026: $98.0 million
+5 more
8 metrics
Cash and cash equivalents
$174.9 million
Balance as of June 30, 2026
Net loss Q2 2026
$50.4 million
Three months ended June 30, 2026
Net loss H1 2026
$98.0 million
Six months ended June 30, 2026
Net cash used in operating activities
$101.7 million
Six months ended June 30, 2026
Total operating expenses
$100.1 million
Six months ended June 30, 2026, up 43% year over year
Equity capital raised since inception
$1,703.7 million
Total equity financing through June 30, 2026
Shares outstanding
296,061,497 shares
Ordinary shares outstanding as of July 16, 2026, including treasury shares
Clinical and manufacturing commitments
$142.7 million
Future contractual commitments across clinical development and manufacturing
Key Terms
epicutaneous immunotherapy, Biologics License Application, research tax credit, pre-funded warrants, +2 more
6 terms
epicutaneous immunotherapy medical
"based on epicutaneous immunotherapy (“EPIT”), a proprietary method of delivering 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.
Biologics License Application regulatory
"anticipated submission of a Biologics License Application (“BLA”) for VIASKIN Peanut to the FDA"
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.
research tax credit financial
"Research Tax Credit (crédit d’impôt recherche, or CIR) granted 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.
pre-funded warrants financial
"pre-funded warrants issued in connection with the March 2025 PIPE Financing were classified as equity"
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.
at-the-market sales agreement financial
"entered into an at-the-market sales agreement (the "Sales Agreement") with Citizens"
An at-the-market sales agreement lets a company raise cash by selling newly issued shares directly into the open market at whatever price buyers are paying that day, using a broker to place the trades over time. Investors should watch these deals because they can dilute existing ownership and put downward pressure on the stock price while giving the company flexible, on-demand funding—like a store gradually listing extra items on an online marketplace at current prices.
foreign exchange swaps financial
"hedged the current account of its US subsidiary through foreign exchange swaps"
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FAQ
What were DBVT’s net loss and loss per share for Q2 2026?
DBV Technologies reported a Q2 2026 net loss of $50.4 million, compared with $41.9 million a year earlier. Basic and diluted net loss per share were $(0.12), versus $(0.31) in Q2 2025, reflecting a larger share base after financings.
How much cash does DBVT (DBVT) have and what is its runway?
As of June 30, 2026, DBV Technologies held $174.9 million in cash and cash equivalents. Management estimates this will fund operations into the third quarter of 2027, based on current plans focused on Viaskin Peanut without additional major programs.
What are DBVT’s plans for Viaskin Peanut BLA submissions?
DBV Technologies plans to submit a Biologics License Application for Viaskin Peanut in children aged 4–7 years in the third quarter of 2026. A separate BLA for toddlers aged 1–3 years is planned for the second half of 2026, conditional on safety data.
How much financing has DBVT raised through the March 2025 PIPE and related warrants?
The March 2025 PIPE provided initial gross proceeds of $125.5 million, followed by full exercise of associated warrants for an additional $195.4 million. Of this, $94.7 million was received in January 2026, significantly bolstering liquidity.
How did DBVT’s operating expenses change in the first half of 2026?
Total operating expenses increased to $100.1 million in the first half of 2026 from $69.9 million in 2025, a 43% rise. The growth reflects higher research and development, sales and marketing, and general and administrative costs tied to BLA readiness and launch planning.
What major manufacturing and commercialization agreements did DBVT sign in 2026?
DBV Technologies signed a long-term Manufacturing Supply Agreement with Fareva La Vallée for peanut source material and letters of intent with Fareva Amboise for commercial-scale manufacturing and with Integrated Commercialization Solutions for U.S. distribution support.
What is DBVT’s cash burn from operations so far in 2026?
Net cash used in operating activities was $101.7 million for the six months ended June 30, 2026, versus $53.6 million a year earlier. The increase mainly reflects expanded clinical development, manufacturing readiness, and commercial launch preparedness for Viaskin Peanut.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
____________________
FORM 10-Q
____________________
(Mark One)
For the quarterly period ended June 30, 2026
or
For the transition period from ______________ to _______________
Commission file number 001-36697
(Exact name of registrant as specified in its charter)
____________________
Not applicable | |||||
State or other jurisdiction of incorporation or organization | (I.R.S. Employer Identification No.) | ||||
N/A | |||||
(Address of principal executive offices) | (Zip Code) | ||||
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 July 16, 2026, the registrant had 296,061,497 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 June 30, 2026 and December 31, 2025 | 2 | ||||||
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) for the Three and Six Months Ended June 30, 2026 and 2025 | 3 | |||||||
Condensed Consolidated Statements of Cash Flows (Unaudited) for the Six Months Ended June 30, 2026 and 2025 | 4 | |||||||
Condensed Consolidated Statements of Changes in Shareholders’ Equity (Unaudited) for the Three and Six Months Ended June 30, 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 | 19 | ||||||
Item 3 | Quantitative and Qualitative Disclosures About Market Risk | 26 | ||||||
Item 4 | Controls and Procedures | 26 | ||||||
Part II | Other Information | 28 | ||||||
Item 1 | Legal Proceedings | 27 | ||||||
Item 1A | Risk Factors | 27 | ||||||
Item 2 | Unregistered Sales of Equity Securities and Use of Proceeds | 28 | ||||||
Item 3 | Defaults Upon Senior Securities | 28 | ||||||
Item 4 | Mine Safety Disclosures | 28 | ||||||
Item 5 | Other Information | 28 | ||||||
Item 6 | Exhibits | 28 | ||||||
Unless the context otherwise requires, we use the terms “DBV”, “DBV Technologies,” the “Company,” “we,” “us” and “our” in this Quarterly Report on Form 10-Q, 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 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;
•the ability of our sole contract manufacturer for VIASKIN Peanut patches to successfully remediate Good Manufacturing Practice deficiencies in response to FDA warning letters;
•our ability to build our own sales and marketing capabilities, or seek collaborative partners, to commercialize VIASKIN Peanut 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 (the “Annual Report”). As a result of the risks and uncertainties, the results or events indicated by the forward-looking statements may not occur. Undue reliance should not be placed on any forward-looking statement. We qualify all of our forward-looking statements by these cautionary statements.
In addition, any forward-looking statement in this Quarterly Report, including statements that “we believe” and similar statements, reflect our beliefs and opinions on the relevant subject and represents our views only as of the date of this Quarterly Report and should not be relied upon as representing our views as of any subsequent date. These statements are based upon information available to us as of the date of this Quarterly Report and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to unduly rely upon these statements. We anticipate that subsequent events and developments may cause our views to change. Although we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, except as required by applicable law. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.
1
PART I – FINANCIAL INFORMATION
Item 1. Financial Statements
DBV Technologies S.A.
Condensed Consolidated Statements of Financial Position (unaudited)
(amounts in millions, except share and per share data)
| Note | June 30, 2026 | December 31, 2025 | |||||||||||||||
| Assets | |||||||||||||||||
| Current assets : | |||||||||||||||||
| Cash and cash equivalents | 3 | ||||||||||||||||
| Other current assets | 5 | ||||||||||||||||
| Total current assets | |||||||||||||||||
| Property, plant, and equipment, net | 4 | ||||||||||||||||
| Right-of-use assets | 6 | ||||||||||||||||
| Other non-current assets | 5 | ||||||||||||||||
| Total non-current assets | |||||||||||||||||
| Total Assets | |||||||||||||||||
| Liabilities and shareholders' equity | |||||||||||||||||
| Current liabilities: | |||||||||||||||||
| Trade payables | 7 | ||||||||||||||||
| Short-term operating leases' liabilities | 6 | ||||||||||||||||
| Current contingencies & Employee Benefits | 11 | ||||||||||||||||
| Other current liabilities | 7 | ||||||||||||||||
| Total current liabilities | |||||||||||||||||
| Long-term operating leases' liabilities | 6 | ||||||||||||||||
| Non-current contingencies & Employee Benefits | 11 | ||||||||||||||||
| Total non-current liabilities | |||||||||||||||||
| Total Liabilities | |||||||||||||||||
| Shareholders’ equity : | 8 | ||||||||||||||||
Ordinary shares, € | |||||||||||||||||
| Additional paid-in capital | |||||||||||||||||
Treasury stock, | ( | ( | |||||||||||||||
| Accumulated deficit | ( | ( | |||||||||||||||
| Accumulated other comprehensive income | |||||||||||||||||
| Accumulated currency translation effect | ( | ( | |||||||||||||||
| Total Shareholders’ equity | |||||||||||||||||
| Total Liabilities and Shareholder's equity | |||||||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
2
DBV Technologies S.A.
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)
(amounts in millions, except share and per share data)
| Note | Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||||||||||||||||
| Operating income | 12 | $ | $ | $ | $ | ||||||||||||||||||||||||
| Operating expenses | 13/17 | ||||||||||||||||||||||||||||
| Research and development expenses | ( | ( | ( | ( | |||||||||||||||||||||||||
| Sales and marketing expenses | ( | ( | ( | ( | |||||||||||||||||||||||||
| General and administrative expenses | ( | ( | ( | ( | |||||||||||||||||||||||||
| Total Operating expenses | ( | ( | ( | ( | |||||||||||||||||||||||||
| Loss from operations | ( | ( | ( | ( | |||||||||||||||||||||||||
| Financial income (expense) | ( | ( | |||||||||||||||||||||||||||
| Loss before taxes | ( | ( | ( | ( | |||||||||||||||||||||||||
| Income tax | ( | ( | ( | ( | |||||||||||||||||||||||||
| Net loss | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||||||||
| Foreign currency translation differences, net of taxes | ( | ( | |||||||||||||||||||||||||||
| Actuarial gains on employee benefits, net of taxes | ( | ||||||||||||||||||||||||||||
| Comprehensive loss | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||||||||
| Basic/diluted Net loss per share attributable to shareholders | 16 | $ | ( | $ | ( | $ | ( | $ | ( | ||||||||||||||||||||
| Weighted average shares outstanding used in computing per share amounts: | 16 | ||||||||||||||||||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
DBV Technologies S.A.
Condensed Consolidated Statements of Cash Flows (unaudited)
(amounts in millions)
| Notes | Six Months Ended June 30, | ||||||||||||||||
| 2026 | 2025 | ||||||||||||||||
| Net loss for the period | $ | ( | $ | ( | |||||||||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||||||||
| Depreciation, amortization and accrued contingencies | 4/11 | ||||||||||||||||
| Expenses related to share-based payments | 10 | ||||||||||||||||
| Inventory write-downs | |||||||||||||||||
| Other | |||||||||||||||||
| Changes in operating assets and liabilities: | |||||||||||||||||
| Decrease (increase) in inventories and work in progress | ( | ( | |||||||||||||||
| Decrease (increase) in other current assets | 5 | ( | ( | ||||||||||||||
| (Decrease) increase in trade payables | 7 | ( | |||||||||||||||
| (Decrease) increase in other current and non-current liabilities | ( | ( | |||||||||||||||
| Change in operating lease liabilities and right of use assets | 6 | ( | |||||||||||||||
| Net cash flow used in operating activities | ( | ( | |||||||||||||||
| Cash flows used in investing activities : | |||||||||||||||||
| Change in property, plant, and equipment | ( | ||||||||||||||||
| Change in Other non-current assets | 5 | ( | ( | ||||||||||||||
| Net cash flows used in investing activities | ( | ( | |||||||||||||||
| Cash flows provided by financing activities : | |||||||||||||||||
| Treasury shares | |||||||||||||||||
| Issuance from Net Capital increase and Share warrants | 8 | ||||||||||||||||
| Net cash flows provided by financing activities | |||||||||||||||||
| Effect of exchange rate changes on cash and cash equivalents | ( | ||||||||||||||||
| Net (decrease) / increase in cash and cash equivalents | ( | ||||||||||||||||
| Net Cash and cash equivalents at the beginning of the period | 3 | ||||||||||||||||
| Net cash and cash equivalents at the end of the period | 3 | $ | |||||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
DBV Technologies S.A.
Condensed Consolidated Statements of Changes in Shareholders’ Equity (unaudited)
(amounts in millions, except share and per share data)
| Ordinary shares | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Number of Shares | Amount | Additional paid-in capital | Treasury stock | Accumulated deficit | Accumulated other comprehensive income (loss) | Accumulated currency translation effect | Total Shareholders’ Equity | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance at January 1, 2025 | ( | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net (loss) | — | — | — | ( | — | — | ( | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other comprehensive income (loss) | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of ordinary shares | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of share warrants | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treasury shares | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Share-based payments | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Allocation of accumulated net losses | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance at March 31, 2025 | ( | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net (loss) | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other comprehensive income (loss) | ( | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of ordinary shares | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of share warrants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treasury shares | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Share-based payments | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Allocation of accumulated net losses | ( | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance at June 30, 2025 | ( | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ordinary shares | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Number of Shares | Amount | Additional paid-in capital | Treasury stock | Accumulated deficit | Accumulated other comprehensive income (loss) | Accumulated currency translation effect | Total Shareholders’ Equity | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance at January 1, 2026 | $ | $ | $ | ( | $ | ( | $ | $ | ( | $ | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net (loss) | — | — | — | — | ( | — | — | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other comprehensive income (loss) | — | — | — | — | — | ( | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of ordinary shares | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of share warrants | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treasury shares | — | — | — | ( | — | — | — | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Share-based payments | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Allocation of accumulated net losses | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance at March 31, 2026 | $ | $ | $ | ( | $ | ( | $ | $ | ( | $ | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net (loss) | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other comprehensive income (loss) | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of ordinary shares | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of share warrants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treasury shares | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Share-based payments | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Allocation of accumulated net losses | ( | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance at June 30, 2026 | $ | $ | $ | ( | $ | ( | $ | $ | ( | $ | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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 with early adoption permitted. The Company does not expect ASU 2025-11 to have a material impact on its interim consolidated financial statements.
In December 2025, the FASB issued ASU 2025‑10, Government Grants (Topic 832): Accounting for Government Grants Received by Business Entities, which establishes authoritative U.S. GAAP guidance for the recognition, measurement, presentation, and disclosure of government grants received by business entities. The amendments are effective for public business entities for annual reporting periods beginning after December 15, 2028, including interim periods within those annual periods, with early adoption permitted. The Company does not expect ASU 2025-10 to have a material impact on its consolidated financial statements.
In April 2026, the FASB issued ASU 2026‑01, Equity (Topic 505): Initial Measurement of Paid‑in‑Kind Dividends on Equity‑Classified Preferred Stock. The ASU provides authoritative guidance on the initial measurement of paid‑in‑kind (“PIK”) dividends issued on equity‑classified preferred stock, addressing diversity in practice. Under the amendments, PIK dividends are required to be initially measured based on the PIK dividend rate stated in the preferred stock agreement, typically applied to the liquidation value of the preferred stock outstanding. The guidance does not affect the determination of when PIK dividends are recognized. The ASU is effective for annual reporting periods beginning after December 15, 2026, including interim periods
6
within those fiscal years, with early adoption permitted. The amendments may be applied on either a prospective basis or a modified retrospective basis. The Company does not expect ASU 2026-01 to have a material impact on its consolidated financial statements.
In May 2026, the FASB issued ASU 2026‑02, introducing a comprehensive framework for the accounting of environmental credits and related obligations. The standard requires entities to recognize environmental credits as assets only when it is probable that they will be used to settle obligations or otherwise transferred, with all other credits expensed as incurred. Measurement is primarily based on cost, with subsequent accounting depending on the intended use of the credits. The ASU also establishes a liability model for environmental credit obligations, measured based on available credits (funded portion) or the cost or fair value of credits to be acquired (unfunded portion). The guidance is effective for public business entities for fiscal years beginning after December 15, 2027, with early adoption permitted. The Company does not expect ASU 2026-02 to have a material impact on its consolidated financial statements.
Use of estimates
The preparation of the Company’s condensed consolidated financial statements requires the use of estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, and disclosures of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amount of income and expenses during the period. The estimates and assumptions, developed based on the information available at the time of closing the accounts, particularly relate to:
•The assessment of the fair value of equity-settled share-based compensation plans granted to employees and/or executives, which is performed using actuarial models. These models require the Company to use certain calculation assumptions, such as the expected volatility of the share price and the estimated timing of achieving performance conditions over the vesting period of the share-based compensation plan ;
•The evaluation of the amount of the Research Tax Credit, which is based on eligible internal and external research expenses incurred by the Company during the fiscal year. Only eligible research expenditures are included in the calculation of the Research Tax Credit;
•The recoverability of the Company’s net deferred tax assets and related valuation allowance
•The assumptions used in the valuation of right-of-use assets & operating leases
•The estimate of provisions and contingencies.
The final amounts may differ from these estimates. Management is also required to exercise judgment in the following area:
Going concern
These condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and the satisfaction of liabilities in the normal course of business for at least twelve months from the date of issuance of these condensed consolidated financial statements. The Company has incurred operating losses and negative cash flows from operations since inception. The Company does not generate revenue and continues to prepare for the potential launch of VIASKIN Peanut in the United States and the European Union, if approved.
As of June 30, 2026, the Company had cash and cash equivalents of $174.9 million. Following the revised timing of the anticipated BLA submission from the second to the third quarter of 2026, management updated the Company’s forecasts to reflect the revised timing of related expenditures and activities, including cost-containment measures. Based on its current operations, plans and assumptions, management estimates that the Company has sufficient funding to support its operations for at least twelve months from the date of issuance of this Form 10-Q, into the third 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 & investing activities increased to $102.6 million for the six months ended June 30, 2026, compared to $54.0 million for the six months ended June 30, 2025 reflecting continued investments in clinical development activities, manufacturing and supply-chain readiness, commercial launch preparedness, and the expansion of the Company’s workforce in preparation for a potential launch of VIASKIN Peanut, if approved. While the Company expects operating cash outflows to remain significant as it advances toward BLA submission and potential commercialization, the Company’s current forecasts incorporate measures intended to align spending with the revised regulatory timeline.
7
Significant contracts
March 2025 PIPE Financing
March 2025 PIPE Financing
In March 2025, the Company completed a private investment in public equity financing generating initial gross proceeds of $125.5 million (€116.3 million) received on April 7, 2025 (“March 2025 PIPE Financing”). Following the announcement of positive VITESSE topline results on December 16, 2025, the warrants issued in connection with the March 2025 PIPE Financing were fully exercised, resulting in additional gross proceeds of $195.4 million (€166.7 million at the exchange rate of 1 EUR = $1.17 ), of which $100.7 million (€85.7 million) was received in the fourth quarter of 2025 and $94.7 million (€81.0 million) was received in January 2026.
The pre-funded warrants issued in connection with the March 2025 PIPE Financing were classified as equity under ASC 480 and ASC 815. Upon exercise, the par value of the newly issued common stocks was recorded in “Common stock” and any additional amount, including the exercise price paid and the remaining carrying amount of the warrants, was recorded in “Additional paid-in capital”. No gain or loss was recognized in the Consolidated Statements of Operations and Comprehensive Loss as the warrants were classified as equity from inception.
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 MS Agreement term. The term is effective for a period of eight (8 ) years and can be renewed for a period of two (2 ) years.
The MS Agreement is subsequent to the Service Agreement that the Company entered into with FLV on March 18, 2024 (the “PSM Services Agreement”), for the construction of a dedicated production line and facility and the transfer of manufacturing of the PSM to FLV required to produce VIASKIN Peanut patches. The PSM Services Agreement also included binding commercial terms which were incorporated into the MS Agreement.
The PSM Services Agreement includes the following services (i) construction activities, (ii) the acquisition of equipment, and (iii) the cGMP qualification of a dedicated PSM production line installed at FLV’s premises. 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 MS 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 June 30, 2026, DBV expects to meet the purchase obligations and therefore did not record any liability or accrual related to these commitments
8
Note 2 Significant Events and Transactions
Letter of intent with Fareva Amboise
On June 25, 2026, the Company entered into a letter of intent with Fareva Amboise (“Fareva”) in connection with the planned commercial-scale manufacturing of the VIASKIN® Peanut patch. Under the letter of intent, Fareva will undertake manufacturing readiness activities, infrastructure and equipment upgrades and workforce expansion intended to support commercial production of VIASKIN® Peanut patch. The parties are currently negotiating a definitive commercial manufacturing and supply agreement. The planned investment for commercial manufacturing is estimated at $7.5 million, of which up to $5.2 million is expected to be supported by the Company through a combination of an FDA approval-contingent upfront payment and manufacturing-related pricing arrangements. The Company expects these activities to support preparedness for future commercialization of VIASKIN® Peanut patch, if approved.
As of June 30, 2026, no material amounts had been incurred by the Company under the letter of intent. Accordingly, the arrangement has no material impact on the Company's condensed consolidated financial statements as of June 30, 2026.
Letter of intent signed with Integrated Commercialization Solutions
On June 5, 2026, the Company entered into a Letter of Intent with Integrated Commercialization Solutions, LLC ("ICS") in connection with future commercialization support and distribution services for the VIASKIN® Peanut patch in the United States, if approved. Under the letter of intent, the parties agreed to undertake certain preliminary launch readiness and implementation planning activities while continuing negotiations toward a definitive commercial outsourcing services agreement. The contemplated activities include operational planning, systems readiness, distribution infrastructure preparation and other commercialization support services intended to facilitate a potential future product launch, if approved.
As of June 30, 2026, no material amounts had been incurred by the Company under the letter of intent. Accordingly, the arrangement has no material impact on the Company's condensed consolidated financial statements as of June 30, 2026.
Manufacturing Supply Agreement (Peanut Source Material) with Fareva La Vallée
On March 17, 2026, the Company entered into the MS Agreement with FLV, under which FLV will manufacture and supply the PSM exclusively for DBV Technologies S.A. during the agreement term. The term is effective for a period of eight (8 ) years and can be renewed for a period of two (2 ) years.
March 2025 PIPE Financing
On January 16, 2026, the Company received the supplemental gross proceeds of $94.7 million (€81 million) resulting in the full exercise of the warrants top purchase 34,090,004 new shares at a part value of €0.10 (the “ABSA Warrants”) and of the warrants to subscribe for 1.75 shares of the Company (the “BS Warrants”) issued in the March 2025 PIPE Financing.
Administrative Proceedings
Note 3 Cash and Cash Equivalents
The following tables summarize the Cash and Cash Equivalents as of June 30, 2026 and December 31, 2025:
| June 30, 2026 | December 31, 2025 | ||||||||||
| Cash | |||||||||||
| Cash Equivalents | |||||||||||
| Total Cash and Cash Equivalents | |||||||||||
Cash and cash equivalents totaled $174.9 million and $194.2 million as of June 30, 2026 and December 31, 2025, respectively. The Company received the receipt of $94.7 million of gross proceeds in January 2026 resulting from the full exercise of the ABSA Warrants and BS Warrants issued in connection with the March 2025 PIPE Financing, used to fund operating activities during the period.
As of June 30, 2026 cash equivalents totaled $151.0 million, compared to $67.1 million as of December 31, 2025. Cash equivalents consist primarily of short-term interest-bearing deposits with original maturities of three months or less when purchased. Management considers these investments to be readily convertible into known amounts of cash and subject to an insignificant risk of changes in value. Accordingly, they are classified as cash equivalents.
The Company actively manages its liquidity by investing excess cash balances in highly liquid, low-risk instruments while maintaining sufficient flexibility to fund operating activities, clinical development programs, manufacturing and supply-chain readiness activities, and potential commercial launch preparations.
9
Note 4 Property, Plant & Equipment
Property and equipment, net consisted of the following:
| 01/01/2026 | Currency translation effect | Increase | Decrease | Reclassification | 06/30/2026 | |||||||||||||||
Laboratory equipment | ( | |||||||||||||||||||
Fixture and installations | ||||||||||||||||||||
Computer equipment | ( | |||||||||||||||||||
Other property, plant and equipment | ||||||||||||||||||||
Property, plant, and equipment in progress | ( | |||||||||||||||||||
| Total, gross | ( | |||||||||||||||||||
Accumulated depreciation of laboratory equipment | ( | ( | ( | |||||||||||||||||
Accumulated depreciation of fixtures and installations | ( | ( | ( | |||||||||||||||||
Accumulated depreciation of computer equipment | ( | ( | ( | |||||||||||||||||
Accumulated depreciation of other property, plant and equipment | ( | ( | ||||||||||||||||||
Less accumulated amortization and depreciation | ( | ( | ( | |||||||||||||||||
| Total, net | ( | ( | ||||||||||||||||||
Note 5 Other Current & Non Current Assets
The following tables summarize the Other Current & Non Current Assets as of June 30, 2026 and December 31, 2025:
| June 30, 2026 | December 31, 2025 | ||||||||||
| Prepaid Right of Use Asset | |||||||||||
| Deposits, pledged securities and other non-current financial assets | |||||||||||
| Liquidity contract | |||||||||||
Total Other non-current assets | |||||||||||
Research tax credit | |||||||||||
VAT Assets | |||||||||||
Prepaid and deferred expenses | |||||||||||
Other receivables | |||||||||||
| Total Other Current Assets | |||||||||||
Prepaid Right of Use Asset
The $3.9 million presents of 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
| Amount in millions of US dollars | |||||
Opening research tax credit receivable as of January 1, 2025 | |||||
‘+ Other operating income | |||||
- Payment received | ( | ||||
| - Adjustment and currency translation effect | |||||
Closing research tax credit receivable as of December 31, 2025 | |||||
Of which - Non-current portion | |||||
Of which - Current portion | |||||
10
| 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 June 30, 2026 | |||||
| Of which - Non-current portion | |||||
| Of which - Current portion | |||||
In the fiscal year ended December 31, 2021, the Company recovered its Small & Medium Enterprise “SME” status under EU law, and became therefore eligible again for the immediate reimbursement of the Research Tax Credit.
VAT Assets
Value-added tax (“VAT”) receivables primarily consisted of recoverable value-added taxes incurred on purchases and operating expenditures. The balance decreased during the period, reflecting the receipt of VAT refunds from tax authorities related to previously submitted claims, partially offset by VAT generated from the Company’s ongoing operating, clinical development and commercial readiness activities.
Prepaid and deferred expenses & Other receivables
Note 6 Lease contracts
Right of use Assets
| Real Estate | Other assets | Total | ||||||||||||||||||
| As of January 1, 2026 | — | — | ||||||||||||||||||
| New right of use assets | ||||||||||||||||||||
| Disposals | ||||||||||||||||||||
| Depreciation and amortization | ( | ( | ||||||||||||||||||
| Foreign exchange and other movements | ( | ( | ||||||||||||||||||
| As of June 30, 2026 | ||||||||||||||||||||
Operating leases' liabilities
Future minimum lease payments under the Company’s operating leases’ right of use as of June 30, 2026 and December 31, 2025 are as follows:
| June 30, 2026 | December 31, 2025 | ||||||||||||||||||||||||||||||||||
| Real Estate | Other assets | Total | Real Estate | Other assets | Total | ||||||||||||||||||||||||||||||
Current portion | |||||||||||||||||||||||||||||||||||
Year 2 | |||||||||||||||||||||||||||||||||||
Year 3 | |||||||||||||||||||||||||||||||||||
Thereafter | |||||||||||||||||||||||||||||||||||
Total minimum lease payments | |||||||||||||||||||||||||||||||||||
Less: Effects of discounting | ( | ( | ( | ( | |||||||||||||||||||||||||||||||
Present value of lease liabilities | |||||||||||||||||||||||||||||||||||
Less: current portion | ( | ( | ( | ( | ( | ||||||||||||||||||||||||||||||
Long-term lease liabilities | |||||||||||||||||||||||||||||||||||
| Weighted average remaining lease term (years) | |||||||||||||||||||||||||||||||||||
Weighted average discount rate | |||||||||||||||||||||||||||||||||||
During the six months ended June 30, 2026, the Company commenced a new operating lease for office facilities in Warren, New Jersey with an initial lease term of approximately 45 months. Upon commencement, the Company recognized $1.9 0.6 million of landlord incentives, including tenant improvement allowances and rent credits, which reduced the initial carrying amount of the right-of-use asset.
The Company recognizes rent expense, calculated as the remaining cost of the lease allocated over the remaining lease term on a straight-line basis. Rent expense presented in the consolidated statement of operations and comprehensive loss was:
| June 30, | |||||||||||
| 2026 | 2025 | ||||||||||
Operating lease expense / (income) | |||||||||||
11
Note 7 Trade Payables and Other Current Liabilities
Trade Payables
| June 30, 2026 | December 31, 2025 | |||||||||||||
| Accounts payable | ||||||||||||||
| Accrued expenses and other current liabilities | ||||||||||||||
| Total Trade Payables | ||||||||||||||
Trade payables decreased from $40.9 million as of December 31, 2025 to $39.4 million as of June 30, 2026. The decrease primarily reflects the settlement of transaction costs accrued at year-end 2025. This reduction was partially offset by higher operating activity during the period, including expenditures related to the COMFORT Toddlers program, BLA readiness initiatives and commercial launch preparedness activities.
Other Current Liabilities
The following table summarizes the other liabilities as of June 30, 2026 and December 31, 2025:
| June 30, 2026 | December 31, 2025 | |||||||||||||
| Social debt | ||||||||||||||
| Tax liabilities | ||||||||||||||
| Other debts | ||||||||||||||
Total Other Current Liabilities | ||||||||||||||
Note 8 Shareholders’ equity
The share capital as of June 30, 2026 is set at the sum of €29,606,149.70 ($33,961,702.00 converted at historical rates). It is divided into 296,061,497 fully authorized, subscribed and paid-up ordinary shares with a par value of €0.10 .
At the Annual General Meeting held on June 3, 2026 (the “General Meeting”), shareholders approved the allocation of the Company's accumulated deficit of $220,838,268 (€190,148,327 ) against additional paid-in capital (share premium).
The table below presents the changes in the share capital of the Company as of June 30, 2026 compared to December 31, 2025 at historical rate:
Amounts in millions of U.S. Dollars except share and per share data | Share capital in USD | Additional paid-in capital | Number of shares | |||||||||||
| Date | Nature of the transactions | |||||||||||||
| Total Equity Balance as of December 31, 2025 | ||||||||||||||
| 02/01/2026 | Capital increase by ordinary shares | |||||||||||||
| 02/01/2026 | Capital increase by ordinary shares | ( | ||||||||||||
| 06/01/2026 | Capital increase by ordinary shares | |||||||||||||
| 06/01/2026 | Capital increase by ordinary shares | |||||||||||||
| 09/01/2026 | Capital increase by employee 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 | ( | ||||||||||||
| 12/5/2026 | Capital increase by ordinary shares | |||||||||||||
| 16/05/2026 | Capital increase by ordinary shares | |||||||||||||
| 22/05/2026 | Capital increase by employee Stock Option | |||||||||||||
| 11/06/2026 | Retained earnings charged on share premium | ( | ||||||||||||
Share-based payments | ||||||||||||||
| Net Issuance of warrants | ||||||||||||||
| Total Equity Balance as of June 30, 2026 | ||||||||||||||
12
Note 9 Fair Value Measurement
The Company reports assets and liabilities recorded at fair value on the Company’s condensed consolidated balance sheets based upon the level of judgment associated with inputs used to measure their fair value.
The fair value measurement level within the fair value hierarchy for a particular asset or liability is based on the lowest level of any input that is significant to the fair value measurement. Valuation techniques maximize the use of observable inputs and minimize the use of unobservable inputs.
Financial instruments not measured at fair value on the Company’s consolidated statement of financial position, but which require disclosure of their fair values include cash and cash equivalents, deposits, liquidity contract, accounts payable, and conditional advances. The fair values of these financial instruments are deemed to approximate their carrying amount.
There has been no transfer between levels of the fair value hierarchy and no change from the consolidated balance sheets ended December 31, 2025.
Derivative Instruments
The Company is exposed to increasing foreign exchange risk due to a portion of its procurement activities being conducted in the United States and invoiced in U.S. dollars, as well as the activity of its subsidiary DBV Technologies Inc., in connection with the Company’s preparation for the potential launch of the VIASKIN Peanut patch in the United States, if approved.
This exposure has been increased by the continued depreciation of the U.S. dollar observed over the past year.
In this context, since 2025, the Company has hedged the current account of its US subsidiary through the use of financial instruments (foreign exchange swaps entered into with banking counterparties), which are linked to the subsidiary’s current account as of June 30, 2026.
The Company’s policy is not to enter into derivative transactions for speculative purposes.
| (In Million of dollars) | As of June 30, 2026 | As of December 31, 2025 | ||||||||||||||||||||||||||||||||||||
| Notional amount | Fair value | Due date | Notional amount | Fair value | Due date | |||||||||||||||||||||||||||||||||
| Asset | Liabilities | <1 year | Asset | Liabilities | <1 year | |||||||||||||||||||||||||||||||||
| Foreign exchange SWAP* Forward sale at maturity | Non-qualified derivative | |||||||||||||||||||||||||||||||||||||
*Forward sale at maturity
The Company's foreign currency swap arrangements do not qualify for hedge accounting. Accordingly, gains and losses arising from changes in fair value are recognized immediately within “Foreign exchange gains/(losses) (excluding operating activities)” in financial income (expense). The Company recorded a loss of $32.2 thousand for the six months ended June 30, 2026, compared with a loss of $5 thousand for the year ended December 31, 2025.
Note 10 Share-Based Payments
The Board of Directors was authorized at the General Meeting to grant restricted stock units (“RSU”), stock options plan (“SO”), and non-employee warrants (Bons de Souscription d’Actions or “BSA”).
There were no changes during the period in the valuation methodologies, vesting terms or accounting policies applicable to the Company’s share-based awards from those disclosed in Note 11 to the consolidated financial statements included in the Annual Report.
During the six months ended June 30, 2026, the Company granted two special performance-based stock unit awards to its Chief Executive Officer, representing an aggregate of up to 5,800,000 RSUs. The awards were granted in two tranches, consisting of 1,740,000 RSUs granted on May 5, 2026 and 4,060,000 RSUs granted on June 5, 2026. The RSUs are subject to a continued presence condition through July 1, 2028 and to performance conditions based on specified VIASKIN® Peanut regulatory milestones. The May 5, 2026 grant is linked to FDA acceptance for review of the applicable VIASKIN® Peanut BLA, with 870,000 RSUs allocated to children aged 4 to 7 years old and 870,000 RSUs allocated to the toddlers aged 1 to 3 years old, or 1,740,000 RSUs if a single BLA covering both age groups is accepted for review.
The June 5, 2026 grant is linked to FDA approval of VIASKIN® Peanut, with 2,900,000 RSUs allocated to the first FDA approval and 1,160,000 RSUs allocated to a second FDA approval, or 4,060,000 RSUs if a single BLA covering both age groups is approved. Vested shares are delivered in four installments through July 1, 2028. The Company recognizes compensation expense for these awards based on the grant-date fair value and its assessment of the probability of achieving the applicable performance conditions.
Changes in outstanding BSAs, stock options and RSUs during the period were as follows:
| Number of outstanding | |||||||||||||||||
| BSA | SO | RSUs | |||||||||||||||
Balance as of December 31, 2025 | |||||||||||||||||
| Granted during the period | |||||||||||||||||
| Forfeited during the period | ( | ( | ( | ||||||||||||||
| Exercised/released during the period | ( | ( | |||||||||||||||
| Expired during the period | ( | ||||||||||||||||
Balance as of June 30, 2026 | |||||||||||||||||
13
During the six months ended June 30, 2026, the Company granted 1.0 million SOs and 6.4 million RSUs. The increase in outstanding awards primarily reflects grants made during the period including CEO special grants, partially offset by routine forfeitures, exercises, releases and expirations.
Share-based payments expense reflected in the condensed consolidated statements of operations is as follows:
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||||||||||||||||
| Research & development | SO | ( | ( | ( | ( | ||||||||||||||||||||||||
| RSU | ( | ( | ( | ( | |||||||||||||||||||||||||
| Sales & marketing | SO | ( | ( | ||||||||||||||||||||||||||
| RSU | ( | ( | |||||||||||||||||||||||||||
| General & administrative | SO | ( | ( | ( | ( | ||||||||||||||||||||||||
| RSU | ( | ( | ( | ( | |||||||||||||||||||||||||
| ( | ( | ( | ( | ||||||||||||||||||||||||||
Note 11 Contingencies & Employee Benefits
The following tables summarize contingencies as of June 30, 2026 and December 31, 2025:
| June 30, 2026 | December 31, 2025 | ||||||||||
| Current contingencies & Employee Benefits | |||||||||||
| Non-current contingencies & Employee Benefits | |||||||||||
| Total contingencies & Employee Benefits | |||||||||||
The changes in contingencies are as follows:
| Pension retirement obligations | Other contingencies | Total | |||||||||||||||
| At January 1, 2026 | |||||||||||||||||
| Increases in liabilities | |||||||||||||||||
| Reversals of unused liabilities | — | — | — | ||||||||||||||
| Actuarial gains and losses on defined-benefit plans | — | — | — | ||||||||||||||
| Currency translation effect | — | — | — | ||||||||||||||
| At June 30, 2026 | |||||||||||||||||
| Of which current | |||||||||||||||||
| Of which non-current | |||||||||||||||||
Note 12 Operating income
The following table summarizes the operating income during the three and six months ended June 30, 2026 and 2025:
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||||||||||||||||||||||
| Research tax credit | |||||||||||||||||||||||||||||||||||
| Total | |||||||||||||||||||||||||||||||||||
14
Note 13 Allocation of Personnel Expenses
The Company had an average of 170 employees during the six months ended June 30, 2026, compared to an average of 109 employees during the six months ended June 30, 2025.
The following table summarizes the allocation of personnel expenses by function during the six months ended June 30, 2026 and 2025:
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||||||||||
| Research and Development expenses | |||||||||||||||||||||||
| Sales & Marketing expenses | |||||||||||||||||||||||
| General & Administrative expenses | |||||||||||||||||||||||
| Total personnel expenses | |||||||||||||||||||||||
The following table summarizes the allocation of personnel expenses by nature during the six months ended June 30, 2026 and 2025:
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||||||||||
| Wages and salaries | |||||||||||||||||||||||
| Social security contributions | |||||||||||||||||||||||
| Expenses for pension commitments | |||||||||||||||||||||||
| Share-based payments | |||||||||||||||||||||||
| Total | |||||||||||||||||||||||
Personnel expenses for the period ended June 30, 2026, increased by $14.4 million compared to the six months ended June 30, 2025 and by $8.2 million compared to the three months ended June 30, 2025. This increase reflects the Company's transition from a clinical-stage organization operating under regulatory uncertainty in early 2025 to a substantially expanded organization focused on BLA execution and commercial launch preparedness following the FDA alignment reached in March 2025 and the completion of the March 2025 PIPE Financing.
As a result, the Company accelerated investments across development, quality, regulatory and commercial functions. The increase in personnel expenses primarily reflects workforce expansion, particularly in the United States, to support COMFORT Toddlers, BLA readiness activities and preparations for the potential commercial launch of the VIASKIN® Peanut patch, if approved.
Note 14 Commitments
In the ordinary course of business, the Company enters into agreements with CROs, contract manufacturing organizations ("CMOs") and strategic manufacturing partners. Certain arrangements include non-cancellable purchase commitments and minimum purchase obligations extending beyond the current reporting period. These commitments are generally not recognized in the consolidated balance sheet until the related goods or services are received, unless recognition of a liability is required under applicable U.S. GAAP, including when a loss contingency is probable and reasonably estimable.
The following table presents our material expenses commitments for future periods:
| 2026 | 2027 | 2028 | Thereafter | Total | |||||||||||||
(Amounts in USD million) | |||||||||||||||||
Clinical development commitments (CRO agreements) | |||||||||||||||||
Manufacturing and supply commitments (CMO agreements) | |||||||||||||||||
| Total contractual commitments | |||||||||||||||||
Manufacturing and supply commitments include obligations under the Company's strategic manufacturing arrangements with Sanofi and Fareva. These commitments include the letter of intent entered into with Fareva Amboise in support of future commercial manufacturing capacity for VIASKIN Peanut, as well as the PDS Services Agreement and Binding Commercial Term Sheet entered into with Fareva La Vallée relating to the establishment of dedicated Peanut Drug Substance ("PDS") manufacturing capabilities and associated transfer services.
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.
15
Note 15 Relationships with Related Parties
During the six months ended June 30, 2026, the Company identified two significant related-party transactions.
•The first transaction relates to the $5.0 million capital contribution made by DBV Technologies S.A. to its wholly-owned subsidiary, DBV Technologies Inc. The contribution was made to support the subsidiary's operating activities and was accounted for as an equity contribution between entities under common control. As a result, the transaction had no impact on the Company's consolidated financial statements.
•The second transaction relates to special performance-based restricted stock unit awards granted to the Company's Chief Executive Officer. The award is subject to both continued service and specified performance conditions tied to regulatory milestones associated with VIASKIN® Peanut. The award was approved by the Board of Directors upon recommendation of the Compensation Committee and is accounted for as a share-based payment arrangement. Additional information regarding the award is included in Note 10 - Share-Based Payments.
Other than the transactions described above, there were no material changes in the nature of the related-party transactions disclosed in Note 17 to the consolidated financial statements included in the Annual Report.
The compensation amounts presented below, which were awarded to the Directors and Officers of the Company totaled $7.1 million.
| Six Months Ended June 30, | |||||||||||
| 2026 | 2025 | ||||||||||
Short-term benefits | |||||||||||
| Post-employment benefits | |||||||||||
Share-based payments | |||||||||||
| Total | |||||||||||
The methods for the valuation of the benefit related to share-based payments are presented in Note 10 Share-Based Payments.
Amounts payable to related parties as of June 30, 2026 and December 31, 2025 are as follows:
| June 30, 2026 | December 31, 2025 | ||||||||||
Compensation | |||||||||||
Pension obligations | |||||||||||
| Total | |||||||||||
The parent company, DBV Technologies S.A., entered into a cash‑pooling agreement with its subsidiaries (DBV Technologies Inc., DBV Technologies Australia Pty Ltd and DBV Pharma SAS), the balance of which amounts to the following:
| June 30, 2026 | December 31, 2025 | ||||||||||
Loans & Advances | |||||||||||
| Total | |||||||||||
Note 16 Loss Per Share
The basic loss per share is calculated by dividing net loss attributable to the Company’s shareholders by the weighted‑average number of ordinary shares outstanding during the period. Following the March 2025 PIPE Financing, this weighted‑average share count includes the shares underlying the pre‑funded warrants, as the remaining cash exercise price for those warrants is considered immaterial.
The computations for basic and diluted loss per share were as follows (in millions of U.S. Dollars except share and per share data):
| Six Months Ended June 30, | |||||||||||
| 2026 | 2025 | ||||||||||
| Net loss | ( | ( | |||||||||
| Weighted average number of ordinary shares | |||||||||||
| Net loss per share attributable to ordinary shareholders, basic and diluted ($/share) | ( | ( | |||||||||
16
| June 30, 2026 | December 31, 2025 | ||||||||||||||||
| Warrants | Shares * | Warrants | Shares * | ||||||||||||||
| Non-employee warrants | |||||||||||||||||
| Stock-options | |||||||||||||||||
| Restricted stock units | |||||||||||||||||
| Prefunded warrants | |||||||||||||||||
| PFW 2022 | |||||||||||||||||
| BSA from ABSA (March 2025 PIPE Financing) | |||||||||||||||||
| PFW1 from PFW-BS-PFW (March 2025 PIPE Financing) | |||||||||||||||||
| BS from PFW-BS-PFW (March 2025 PIPE Financing) | |||||||||||||||||
| PFW2 (March 2025 PIPE Financing) | |||||||||||||||||
Total Shares | |||||||||||||||||
Note 17 Reportable segment disclosure
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||||||
| Clinical studies | ||||||||||||||||||||
| BLA & Regulatory | ||||||||||||||||||||
| Medical Affairs & Other Medical | ||||||||||||||||||||
| Research & Innovation | ||||||||||||||||||||
| Manufacturing & Supply and Quality | ||||||||||||||||||||
| Sales & Marketing | ||||||||||||||||||||
| General & Administrative | ||||||||||||||||||||
| Total expenses | ||||||||||||||||||||
The Company operates and is managed as one
The Company’s Chief Executive Officer as the chief operating decision maker (“CODM”) manages and allocates resources to the operations of the total company by assessing the overall level of resources available and how to best allocate them to support the Company’s long-term company-wide strategic goals. In making this decision, the CODM uses consolidated financial information for the purposes of evaluating performance, allocating resources, setting incentive compensation targets and planning and forecasting for future periods.
The CODM's analysis includes a comparison to budgeted results. Segment assets provided to the CODM are consistent with those reported on the Consolidated Statement of Financial Position with particular emphasis on the Company's available liquidity including cash, cash equivalents.
Note 18 Events after the Close of the Period
Services Agreement with Fareva La Vallée - Peanut Drug Substance
On July 8, 2026, the Company entered into a PDS Services Agreement and Binding Commercial Term Sheet with FLV relating to the construction development, installation and qualification of a dedicated Peanut Drug Substance (“ PDS”) manufacturing line, as well as related transfer services for technical and validation batches.
On July 8, 2026, the Company entered into a PDS Services Agreement and Binding Commercial Term Sheet with FLV relating to the construction development, installation and qualification of a dedicated Peanut Drug Substance (“ PDS”) manufacturing line, as well as related transfer services for technical and validation batches.
The PDS facility services are expected to be completed no later than September 30, 2027, and the transfer services no later than September 1, 2028. The Company’s commitments under the agreement include PDS facility services fees capped at $4.0 million, excluding certain capital expenditures directly supported by the Company, and transfer services fees capped at $3.0 million. The Company will also directly order and pay for certain equipment required for the dedicated PDS line, which will be owned by the Company. The agreement also includes binding commercial terms expected to be incorporated into a future definitive manufacturing and supply agreement.
The Company concluded that this agreement represents a non-recognized subsequent event as of June 30, 2026.
17
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 patch, which has been evaluated as a potential therapy for children with peanut allergy in twelve completed clinical trials, including five Phase 2 trials and five completed Phase 3 trials. The Company is planning for a BLA submission in the third quarter of 2026 for Viaskin Peanut patch as a potential treatment for children 4 through 7 years old. The Company also has an ongoing Phase 3 supplementary safety study of Viaskin Peanut patch in peanut-allergic toddlers ages one through three. Conditional on successful completion of this safety study, the Company is planning for a BLA submission in the second half of 2026 for children ages one to three.
The Company has earlier-stage food allergy programs including Viaskin Milk and other autoimmune inflammatory diseases.
Recent developments
During the second quarter of 2026, the Company continued to advance the key elements supporting the potential commercialization of VIASKIN® Peanut, including regulatory readiness, clinical development, manufacturing and supply-chain preparedness, commercial launch planning and institutional investor engagement.
Regulatory Development
BLA Submission Update for VIASKIN® Peanut Patch for children aged 4 through7 years
On June 29, 2026, the Company announced that it has had ongoing detailed iterative engagement with FDA with the goal of ensuring a complete, efficient, and timely review of the Company’s BLA for children aged 4 through 7 years, and, through this process and based on FDA review, DBV received valuable, actionable input from the FDA, specific to the organization, mapping, and formatting of existing data sets for the CMC and biostatistical elements of the BLA. The Company announced further that it will take the required time to incorporate the FDA’s feedback and anticipates the BLA filing to occur in the third quarter of 2026. The FDA did not request any additional data.
Clinical Development Update
Initiation of Phase 2 THRIVE Study
On June 2, 2026, the Company announced that the first participant had been screened in the Phase 2 THRIVE study evaluating the efficacy and safety of the VIASKIN® Peanut patch in infants aged 6 through 12 months with peanut allergy. THRIVE is a single-arm, open-label study designed to assess the ability of participants to achieve ad lib consumption of dietary peanut following treatment with the VIASKIN® Peanut patch for 36 months. The Company believes the THRIVE study may provide additional information regarding the potential use of the VIASKIN® Peanut patch in younger patient populations.
Financing
March 2025 PIPE Financing
The Company has received the supplemental gross proceeds of $94 million (€81 million) resulting in the full exercise of the ABSA Warrants and BS Warrants issued on its March 2025 PIPE Financing.
18
Manufacturing and supply-chain readiness
Letter of intent signed with Fareva Amboise
On June 25, 2026, the Company entered into a letter of intent with Fareva in connection with the planned commercial-scale manufacturing of the VIASKIN® Peanut patch. Under the letter of intent, Fareva will undertake manufacturing readiness activities, infrastructure and equipment upgrades and workforce expansion intended to support commercial production of VIASKIN® Peanut patch. The parties are currently negotiating a definitive commercial manufacturing and supply agreement. The planned investment for commercial manufacturing is estimated at $7.5 million, of which up to $5.2 million is expected to be supported by the Company through a combination of an FDA approval-contingent upfront payment and manufacturing-related pricing arrangements. The Company expects these activities to support preparedness for future commercialization of VIASKIN® Peanut patch, if approved.
Letter of intent signed with ICS
On June 5, 2026, the Company entered into a letter of intent with ICS in connection with future commercialization support and distribution services for the VIASKIN® Peanut patch, if approved, in the United States. Under the letter of intent, the parties agreed to undertake certain preliminary launch readiness and implementation planning activities while continuing negotiations toward a definitive commercial outsourcing services agreement. The contemplated activities include operational planning, systems readiness, distribution infrastructure preparation and other commercialization support services intended to facilitate a potential future product launch, if approved.
Manufacturing Supply Agreement (Peanut Source Material) with 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.
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.
Business Trends and Results of Operations
Comparison of the Three Months Ended June 30, 2026 and 2025
The following table summarizes our results of operations, derived from our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in millions of U.S. dollars, for the three months ended June 30, 2026 and 2025.
| Three Months Ended June 30, | |||||||||||||||||||||||
| 2026 | 2025 | $ change | % of change | ||||||||||||||||||||
Operating income | 0.7 | 1.5 | (0.7) | (51)% | |||||||||||||||||||
Operating expenses | |||||||||||||||||||||||
| Research and development expenses | (31.2) | (33.7) | 2.5 | (7)% | |||||||||||||||||||
| Sales and marketing expenses | (5.5) | (0.4) | (5.1) | 1225% | |||||||||||||||||||
| General and administrative expenses | (14.6) | (8.5) | (6.1) | 72% | |||||||||||||||||||
| Total Operating expenses | (51.3) | (42.6) | (8.7) | 21% | |||||||||||||||||||
Financial income (expense) | 0.4 | (0.6) | 1.0 | (162)% | |||||||||||||||||||
Income tax | (0.2) | (0.1) | (0.1) | 89% | |||||||||||||||||||
Net loss | (50.4) | (41.9) | (8.5) | 20% | |||||||||||||||||||
19
Operating Income
The following table summarizes our operating income during the three months ended June 30, 2026 and 2025:
| Three Months Ended June 30, | |||||||||||||||||||||||
| 2026 | 2025 | $ change | % of change | ||||||||||||||||||||
Other income | 0.7 | 1.5 | (0.7) | (51)% | |||||||||||||||||||
| Research tax credit | 0.7 | 1.5 | (0.7) | (51)% | |||||||||||||||||||
Total operating income | 0.7 | 1.5 | (0.7) | (51)% | |||||||||||||||||||
The Company did not generate Revenue from operating activities.
Research tax credit decreased by $0.7 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025. The accrual is consistent with the prior quarter and reflects the lower level of eligible research activities, as the Company’s focus continues to shift from clinical development toward commercial readiness activities.
Operating Expenses
Research and Development Expenses
The following table summarizes our research and development expenses incurred during the three months ended June 30, 2026 and 2025:
| Research and Development expenses | Three Months Ended June 30, | ||||||||||||||||||||||
| 2026 | 2025 | $ change | % of change | ||||||||||||||||||||
External clinical-related expenses | 16.9 | 20.2 | (3.2) | (16)% | |||||||||||||||||||
Employee-related costs | 8.1 | 5.2 | 3.0 | 58% | |||||||||||||||||||
Share-based payment expenses | 1.3 | 0.5 | 0.7 | 136% | |||||||||||||||||||
Depreciation, amortization and other costs | 2.2 | 1.9 | 0.4 | 20% | |||||||||||||||||||
Pre-Commercial Inventory | 2.6 | 6.0 | (3.4) | (56)% | |||||||||||||||||||
| Total Research and Development expenses | 31.2 | 33.7 | (2.5) | (7)% | |||||||||||||||||||
External clinical-related expenses decreased by $(3.2) million for the three months ended ended June 30, 2026, compared to the three months ended June 30, 2025. The decrease was primarily driven by the completion of the EPOPEX study, while expenditures associated with the VITESSE and COMFORT Toddlers programs remained globally consistent.
Employee-related costs increased by $3.0 million for the three months ended ended June 30, 2026, compared to the three months ended June 30, 2025. This increase was mainly driven by hirings to support development, medical affairs, regulatory and quality capabilities.
Pre-commercial inventory continues to increase during the period by $2.6 million as June 30, 2026 as the Company progresses with its commercialization readiness activities. The Company expenses Pre-commercial inventory until BLA approval.
Sales and Marketing Expenses
The following table summarizes our sales and marketing expenses incurred during the three months ended ended June 30, 2026 and 2025:
| Sales & Marketing expenses | Three Months Ended June 30, | ||||||||||||||||||||||
| 2026 | 2025 | $ change | % of change | ||||||||||||||||||||
External professional services | 3.3 | 0.2 | 3.1 | 2046% | |||||||||||||||||||
Employee-related costs | 1.9 | 0.2 | 1.7 | 981% | |||||||||||||||||||
Share-based payment expenses | 0.3 | — | 0.3 | 1443% | |||||||||||||||||||
Depreciation, amortization and other costs | 0.1 | 0.1 | — | (17)% | |||||||||||||||||||
| Total Sales & Marketing expenses | 5.5 | 0.4 | 5.1 | 1225% | |||||||||||||||||||
Sales and marketing expenses have increased by $5.1 million during the three months ended June 30, 2026, compared to the three months ended June 30, 2025, primarily reflecting the continued execution of the Company’s commercial launch readiness strategy in the United States. The increase was driven by higher personnel and external costs associated with the expansion of commercial, market access and launch-support capabilities in preparation for a potential launch of VIASKIN® Peanut, if approved.
20
General and Administrative Expenses
The following table summarizes our general and administrative expenses incurred during the three months ended June 30, 2026 and 2025:
| General & Administrative expenses | Three Months Ended June 30, | ||||||||||||||||||||||
| 2026 | 2025 | $ change | % of change | ||||||||||||||||||||
External professional services | 4.7 | 2.6 | 2.2 | 85% | |||||||||||||||||||
Employee-related costs | 4.3 | 3.2 | 1.1 | 34% | |||||||||||||||||||
Share-based payment expenses | 2.1 | 0.7 | 1.4 | 205% | |||||||||||||||||||
Depreciation, amortization and other costs | 3.4 | 2.0 | 1.4 | 72% | |||||||||||||||||||
| Total General & Administrative expenses | 14.6 | 8.5 | 6.1 | 72% | |||||||||||||||||||
General and Administrative expenses increased by $6.1 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025, primarily reflecting continued scaling of the Company’s corporate infrastructure to support BLA readiness and commercial launch preparedness.
Financial Income (Expense)
Our financial income was $0.4 million for the three months ended June 30, 2026, compared to a financial expense of $0.6 million for the three months ended June 30, 2025, primarily reflecting higher interest income generated from the investment of available cash following the Company’s 2025 financing transactions, in accordance with its treasury policy. The increase was partially offset by foreign exchange unfavorable effects.
Income Tax
Our income tax expense was $0.2 million for the three months ended June 30, 2026 and was $0.1 million for the three months ended June 30, 2025.
Net Loss
Net loss was $50.4 million for the three months ended June 30, 2026, compared to $41.9 million for the three months ended June 30, 2025. Net loss per share (based on the weighted average number of shares outstanding over the period) was $(0.12) and $(0.31) for the three months ended June 30, 2026 and 2025, respectively. This improvement reflects a significantly strengthened equity base following recent financings.
Comparison of the Six Months Ended June 30, 2026 and 2025
The following table summarizes our results of operations, derived from our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in millions of U.S. dollars, for the six months ended June 30, 2026 and 2025.
| Six Months Ended June 30, | |||||||||||||||||||||||
| 2026 | 2025 | $ change | % of change | ||||||||||||||||||||
| Operating income | 1.6 | 2.2 | (0.6) | (27)% | |||||||||||||||||||
| Operating expenses | |||||||||||||||||||||||
| Research and development expenses | (64.6) | (55.2) | (9.4) | 17% | |||||||||||||||||||
| Sales and marketing expenses | (10.4) | (0.7) | (9.7) | 1426% | |||||||||||||||||||
| General and administrative expenses | (25.1) | (14.1) | (11.0) | 78% | |||||||||||||||||||
| Total Operating expenses | (100.1) | (69.9) | (30.1) | 43% | |||||||||||||||||||
| Financial income (expense) | 0.9 | (1.1) | 2.0 | (184)% | |||||||||||||||||||
| Income tax | (0.4) | (0.1) | (0.3) | 278% | |||||||||||||||||||
| Net loss | (98.0) | (69.0) | (29.0) | 42% | |||||||||||||||||||
Operating Income
The following table summarizes our operating income during the six months ended June 30, 2026 and 2025:
| Six Months Ended June 30, | |||||||||||||||||||||||
| 2026 | 2025 | $ change | % of change | ||||||||||||||||||||
| Research tax credit | 1.6 | 2.2 | (0.6) | (28)% | |||||||||||||||||||
Total Other operating income | 1.6 | 2.2 | (0.6) | (28)% | |||||||||||||||||||
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 $1.6 million as of June 30, 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.
21
Operating Expenses
Research and Development Expenses
The following table summarizes our research and development expenses incurred during the six months ended June 30, 2026 and 2025:
| Six Months Ended June 30, | |||||||||||||||||||||||
| 2026 | 2025 | $ change | % of change | ||||||||||||||||||||
| External clinical-related expenses | 36.6 | 30.3 | 6.3 | 21% | |||||||||||||||||||
| Employee-related costs | 15.5 | 9.2 | 6.3 | 68% | |||||||||||||||||||
| Share-based payment expenses | 2.4 | 1.1 | 1.2 | 110% | |||||||||||||||||||
| Depreciation, amortization and other costs | 4.4 | 4.3 | 0.1 | 3% | |||||||||||||||||||
| Pre-Commercial Inventory | 5.6 | 10.3 | (4.6) | (45)% | |||||||||||||||||||
| Total Research and Development expenses | 64.6 | 55.2 | 9.4 | 17% | |||||||||||||||||||
External clinical-related expenses increased by $6.3 million for the six months ended June 30, 2026 compared to the six months ended. The increase primarily reflects higher clinical trial activity during the first half of 2026, including COMFORT Toddlers study, and to the acceleration of BLA readiness activities to prepare BLA submission. These higher costs were partially offset by lower external clinical-related expenses in the second quarter 2026, primarily due to the completion of EPOPEX study.
Employee-related costs and share based payment expenses respectively increased by $6.3 million and $1.2 million for the six months ended June 30, 2026, compared to the six months ended June 30, 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 $5.6 million in anticipation of potential FDA approval. The Company expenses Pre-commercial inventory until BLA approval.
Sales and Marketing Expenses
The following table summarizes our sales and marketing expenses incurred during the six months ended June 30, 2026 and 2025:
| Six Months Ended June 30, | |||||||||||||||||||||||
| 2026 | 2025 | $ change | % of change | ||||||||||||||||||||
| External professional services | 6.9 | 0.3 | 6.7 | 2584% | |||||||||||||||||||
| Employee-related costs | 2.8 | 0.3 | 2.5 | 790% | |||||||||||||||||||
| Share-based payment expenses | 0.4 | — | 0.4 | 1017% | |||||||||||||||||||
| Depreciation, amortization and other costs | 0.3 | 0.1 | 0.2 | 261% | |||||||||||||||||||
| Total Sales & Marketing expenses | 10.4 | 0.7 | 9.7 | 1427% | |||||||||||||||||||
Sales and marketing expenses increased by $9.7 million during the six months ended June 30, 2026, compared to the six months ended June 30, 2025. The prior-year period represented an earlier stage of the Company’s commercialization strategy, before FDA alignment on the planned BLA submission pathway and completion of the March 2025 PIPE Financing. Following these milestones, the Company accelerated investments in commercial infrastructure, market access and launch-support functions in the United States to support BLA readiness and preparation for a potential commercialization of VIASKIN® Peanut, if approved.
General and Administrative Expenses
The following table summarizes our general and administrative expenses incurred during the six months ended June 30, 2026 and 2025:
| General & Administrative expenses | Six Months Ended June 30, | ||||||||||||||||||||||
| 2026 | 2025 | $ change | % of change | ||||||||||||||||||||
| External professional services | 6.9 | 3.6 | 3.3 | 91% | |||||||||||||||||||
| Employee-related costs | 7.8 | 5.1 | 2.7 | 52% | |||||||||||||||||||
| Share-based payment expenses | 3.2 | 1.8 | 1.4 | 78% | |||||||||||||||||||
| Depreciation, amortization and other costs | 7.3 | 3.6 | 3.7 | 103% | |||||||||||||||||||
| Total General & Administrative expenses | 25.1 | 14.1 | 11.0 | 78% | |||||||||||||||||||
General and Administrative expenses increased by $11.0 million for the six months ended June 30, 2026, compared to the six months ended June 30, 2025.
The increase reflects the Company’s broader organizational transition following the March 2025 FDA alignment and March 2025 PIPE Financing, which enabled the Company to expand corporate capabilities required to support late-stage regulatory execution, commercial readiness and public-company infrastructure. Other operating expenses also increased mainly driven by the extension of the New Jersey office lease, D&O insurance as well as patents and licenses expenses.
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Financial Income (Expense)
Our financial income was $0.9 million for the six months ended June 30, 2026, compared to a financial expense of $1.1 million for the six months ended June 30, 2025 an increase reflecting interest yield earned on excess cash balances following the March 2025 PIPE Financing. The improvement also reflects the implementation of a foreign exchange risk management strategy intended to reduce exposure to U.S. dollar volatility.
Income Tax
Our income tax expense was $0.4 million for the six months ended June 30, 2026 compared to $0.1 million for the six months ended June 30, 2025.
Net Loss
Net loss was $98.0 million for the six months ended June 30, 2026, compared to $69.0 million for the six months ended June 30, 2025. Net loss per share (based on the weighted average number of shares outstanding over the period) decreased from $(0.58) to $(0.23) for the six months ended June 30, 2025 and June 30, 2026, respectively. This improvement reflects a significantly strengthened equity base following recent financings.
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 June 30, 2026, the Company held $174.9 million in cash and cash equivalents compared to $194.2 million of cash and cash equivalents held on December 31, 2025. Net cash used for operating activities was $101.7 million and $53.6 million for the periods ended June 30, 2026 and June 30, 2025, respectively. The Company’s net cash flows provided by financing activities totaled $89.0 million for the periods ended June 30, 2026 and $117.0 million in June 30, 2025, following the 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 six months ended June 30, 2026, the euro depreciated against the U.S. dollar, resulting in a $(5.3) million unfavorable foreign currency translation adjustment recognized in other comprehensive loss and a $(5.6) 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. The Company utilizes foreign exchange swap instruments to manage a portion of this exposure, as described in Note 9 to the condensed consolidated financial statements; however, there can be no assurance that such measures will fully offset the impact of adverse currency movements on the Company's results of operations, cash flows or financial condition.
Sources of Liquidity and Material Cash Requirements
Since its inception and up to June 30, 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 | ||||||||||||||||
| Before 2023 | 1,309.7 | ||||||||||||||||
| 2023 | 7.8 | ||||||||||||||||
| 2024 | — | ||||||||||||||||
| 2025 | 291.5 | ||||||||||||||||
| 2026 | 94.7 | ||||||||||||||||
| Total | 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 entered into an at-the-market sales agreement (the "Sales Agreement") with Citizens JMP Securities, LLC ("Citizens"), under which the Company could offer and sell, from time to time, at its sole discretion, ADSs having an aggregate offering price of up to $150.0 million through Citizens. Citizens received commissions of up to 3.0% of the gross proceeds of any ADSs sold through Citizens under the Sales Agreement. The ADSs were offered and sold pursuant to the Company's shelf registration statement on Form S-3, which was originally filed with the Securities and Exchange Commission on April 6, 2023. During the fourth quarter of 2025, the Company received approximately $65 million in gross proceeds from the sale of 4,790,552 ADSs under the Sales Agreement, after deducting sales commissions and offering expenses. No sales were made under the Sales Agreement during the six months ended June 30, 2026. The Form S-3 under which the Sales Agreement was established expired in April
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2026; accordingly, the Company is currently unable to make additional sales under the Sales Agreement until a new registration statement on Form S-3 becomes effective and a new prospectus supplement is filed.
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 Company expects future cash requirements to be driven primarily by the continued advancement of its clinical programs, BLA readiness activities, commercial launch preparedness, manufacturing scale-up initiatives, operating lease obligations and contractual commitments under strategic manufacturing and supply agreements, including arrangements with Sanofi and Fareva. Further information regarding these commitments is provided in Note 14 to the condensed consolidated financial statements.
The commitment amounts are based on contractual obligations that incorporate fixed or minimum service commitments, fixed, minimum, or variable pricing mechanisms, and the anticipated timing of the related contractual activities. Future events could cause actual payments to differ from these estimates. The Company continues to monitor geopolitical and macroeconomic developments and, while such conditions may affect future operating costs, supply chains and foreign exchange markets, management does not believe they have had a material impact on the Company's condensed consolidated financial statements as of June 30, 2026.
Forward-looking
As of June 30, 2026, the Company had cash and cash equivalents of $174.9 million. Following the revised timing of the anticipated BLA submission from the second to the third quarter of 2026, management updated the Company’s forecasts to reflect the revised timing of related expenditures and activities, including cost-containment measures. Based on its current operations, plans and assumptions, management estimates that the Company has sufficient funding to support its operations for at least twelve months from the date of issuance of this Form 10‑Q, into the third 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 timing and amount of the Company’s future cash requirements may vary materially from current expectations depending on, among other factors, the timing and scope of regulatory interactions, the pace of clinical enrollment, manufacturing-related commitments, commercial readiness activities, foreign exchange rate fluctuations and other factors. The Company may seek additional capital in the future through new or existing financing strategies to support its long-term corporate strategy.
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.
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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 June 30, 2026, our management, including our Chief Executive Officer and Chief Financial Officer, concluded that our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act) were effective to provide reasonable assurance that (i) the information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and (ii) such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting identified in management’s evaluation pursuant to Rules 13a-15(d) or 15d-15(d) of the Exchange Act during the period covered by this Quarterly Report on Form 10-Q that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Limitation on Effectiveness of Controls and Procedures
Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision making can be faulty and that breakdowns can occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies and procedures. Because of the inherent limitations in a cost-effective control system, misstatements due to error of fraud may occur and not be detected.
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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. There have been no material changes in our risk factors from those disclosed in the Annual Report, aside from those disclosed below. 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.
Relying on third-party manufacturers may result in delays in our clinical development or commercialization efforts.
Developing and commercializing new medicines entails significant risks and expenses. Our clinical trials may be delayed if third-party manufacturers are unable to assure a sufficient quantity of the drug product to meet our study needs. Currently, we have only one manufacturer, Sanofi S.A., or Sanofi, of the API used in our Viaskin product candidates, including Viaskin Peanut patch, such as peanut protein extract and unmodified allergen milk extract. In February 2020, Sanofi announced that it planned to create a new company dedicated to the production and marketing to third parties of API. Subsequently, Sanofi consolidated its API commercial and development activities conducted in six of its European API production sites. While those API sites do not include the site in which the API used in our Viaskin product candidates is produced, there can be no assurances that this transition will not adversely impact our supply of API from Sanofi. If Sanofi does not continue to manufacture the API as required by us in a timely manner, we may not be able to find a substitute manufacturer on a timely basis and our commercialization efforts and clinical trials may be delayed. Notwithstanding contractual protections, Sanofi may be able to utilize knowledge gained through their relationship with us in furtherance of their development of competitive therapies.
In December 2025, Stallergenes Greer announced that it intends to discontinue the commercialization of Palforzia, on July 31, 2026, for business reasons.
We also expect to rely on Sanofi and on FAREVA for the manufacturing of the patch and on other third-party manufacturers for the manufacturing of commercial supply of Viaskin Peanut, if approved, and any other product for which we obtain regulatory approval. Sanofi may not be able to effectively scale its manufacturing capacity of our API to meet our commercialization needs and we may be unable to establish any agreements with other third-party manufacturers or to do so on acceptable terms. Even if Sanofi is able to meet our commercialization needs or if we are able to establish agreements with other third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:
•reliance on the third party for regulatory compliance and quality assurance;
•the possible breach of the manufacturing agreement by the third party;
•the possible misappropriation of our proprietary information, including our trade secrets and know-how; and
•the possible termination or non-renewal of the agreement by the third party at a time that is costly or inconvenient for us.
Once regulatory approval is obtained, a marketed product and its manufacturer are subject to continual review. The discovery of previously unknown problems with a product or manufacturer may result in restrictions on the product, manufacturer or manufacturing facility, including withdrawal of the product from the market. Manufacturers of products with which we contract are required to operate in accordance with FDA-mandated cGMPs or comparable GMP requirements in foreign countries. A failure of any of our contract manufacturers to establish and follow cGMPs and to document their adherence to such practices may lead to significant delays in the launch or availability of products based on our product candidates into the market. Moreover, the constituent parts of a combination product retain their regulatory status (as a biologic or medical device, for example) and, as such, we or our contract manufacturers may be subject to additional requirements in the QSR or comparable quality management systems in foreign countries, applicable to medical devices, such as design controls, purchasing controls, and corrective and preventive action. We, our contract manufacturers, any future collaborators and their contract manufacturers could be subject to periodic unannounced inspections by the FDA or other comparable foreign regulatory authorities, to monitor and ensure compliance with cGMP. Despite our efforts to audit and verify regulatory compliance, one or more of our third-party manufacturing vendors may be found on regulatory inspection by the FDA or other comparable foreign regulatory authorities to be noncompliant with cGMP regulations. Failure by third-party manufacturers to comply with applicable regulations could result in sanctions being imposed on us, including shutdown of the third-party vendor, fines, injunctions, civil penalties, revocation or suspension of regulatory approval for any products granted pre-market approvals, invalidation of drug product lots or processes, seizures or recalls of products, operating restrictions, and criminal prosecutions.
We have been informed by FAREVA Amboise (“FAREVA”), our sole contract manufacturer for Viaskin Peanut patches, that the FDA has issued warning letters to FAREVA identifying certain current Good Manufacturing Practice (“cGMP”) deficiencies, including at the FAREVA facility at which our Viaskin Peanut patches are manufactured. We are working collaboratively with FAREVA on its remediation and mitigation efforts in response to these warning letters. If FAREVA is unable to remediate these deficiencies to the FDA's satisfaction in a timely manner, or if the FDA takes further enforcement action with respect to the FAREVA Amboise facility, our ability to manufacture Viaskin Peanut patches for our clinical trials or, if approved, for commercial supply could be materially and adversely affected. Because FAREVA is currently our sole manufacturer of Viaskin Peanut patches, we do not have an alternative manufacturing source to which we could readily transition, and any interruption or restriction on manufacturing at the FAREVA Amboise facility could significantly delay our clinical development and regulatory timelines, including timing of the filing, acceptance or approval of our anticipated BLA submission for the Viaskin Peanut patch in children ages 4 through 7 years, and could have a material adverse effect on our business, results of operations, and financial condition.
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Our current and anticipated future dependence upon others for the manufacture of our product candidates or products, if approved, may adversely affect our future profit margins and our ability to commercialize any products that receive regulatory approval on a timely and competitive basis.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
During the six months ended June 30,2026, none
Item 6. Exhibits
Exhibit Index
| Exhibit | Description | Incorporated by Reference | |||||||||||||||
| Schedule/ Form | File Number | Exhibit | File Date | ||||||||||||||
3.1 | Amended and Restated By-laws (status) of the registrant (English translation) | Form 8-K | 001-36697 | 3.1 | June 3, 2026 | ||||||||||||
10.1 | 2026 Stock Option Plan (English Translation) | S-8 | 333-296484 | 99.1 | June 4, 2026 | ||||||||||||
10.2 | 2026 Free Share Plan (English Translation) | S-8 | 333-296484 | 99.2 | June 4, 2026 | ||||||||||||
10.3 | 2026 Performance Share Unit Plan (English Translation) | S-8 | 333-295536 | 99.3 | June 4, 2026 | ||||||||||||
10.4 | 2026 Performance Share Unit Plan (English Translation) | S-8 | 333-295536 | 99.1 | May 4, 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. | |||||||||||||||||
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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: July 16, 2026 | By: | /s/ Daniel Tassé | ||||||
Daniel Tassé | ||||||||
Chief Executive Officer | ||||||||
(Principal Executive Officer) | ||||||||
Date: July 16, 2026 | By: | /s/ Virginie Boucinha | ||||||
Virginie Boucinha | ||||||||
Chief Financial Officer | ||||||||
(Principal Financial and Accounting Officer) | ||||||||
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