DBV Technologies S.A.
For the period ended Dec 31, 2025. Filed Mar 26, 2026.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Mar 26, 2026
DBVT$10.45+6.6%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2024-12-31; filed 2025-04-11.
0001613780-25-000006
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-K
Period ended 2025-12-31; filed 2026-03-26.
0001628280-26-021504
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 172 previous paragraphs and 149 current paragraphs.
29 unchanged; 23 reworded; 97 added; 119 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 10 previous and 11 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (97)
Current report
2025 Year in review
Current report
In 2025, the Company made significant progress advancing the VIASKIN Peanut patch toward commercialization (if approved), secured transformative financing, and identified regulatory pathways for our product candidates through discussions with and written responses from the FDA. As we enter 2026, our focus shifts toward commercialization and laying the groundwork to transform the lives of children living with peanut allergy.
Current report
Since March 2025, we have increased cash and cash equivalents through our financing activities. We believe our cash and cash equivalents, (as of the date of this report as of December 31, 2025), are sufficient to pursue operations and prepare for the potential U.S. launch of the VIASKIN Peanut patch for children aged 4–7, if approved.
Current report
The Company has proven our ability to perform under pressure and achieve key results, as seen in the announcement of the positive topline results of the VITESSE clinical study and successful financing. The Company’s goal is to broaden FDA-approved options for pediatric peanut allergy while delivering value to stakeholders.
Current report
Financing
Current report
On January 16, 2026, the Company announced additional gross proceeds of $195 million (€166.7 million at the exchange rate of 1 EUR = $1.17) resulting from the full exercise of the ABSA Warrants and BS Warrants, following the announcement of the positive VITESSE Topline Results on December 16, 2025. Of these proceeds, $100.7 million in gross proceeds (€85.7 million, at the exchange rate of 1 EUR = $1.17) was received as of December 31, 2025, with the remaining amount received in January 2026.
Current report
The Accounting treatment is detailed into Note 1 Nature of the business and principles and accounting methods, Significant contracts.
Current report
F - 70
Current report
In September 2025, the Company entered into a Sales Agreement (the “Sales Agreement”) with Citizens JMP Securities, LLC (“Citizens”), with respect to an equity offering program (the “ATM Offering”) pursuant to which the Company may offer and sell ADSs, from time to time, through Citizens as its sales agent. Pursuant to the Sales Agreement and a prospectus supplement the Company has filed related to the ATM Offering, the Company may offer and sell ADSs having an aggregate offering price of up to $150.0 million from time to time through Citizens. The issuance and sale, if any, of the ADSs by the Company under the Sales Agreement will be made pursuant to the Company’s previously filed and effective registration statement on Form S-3 (Registration Statement No. 333-271166). Sales of the Company’s ADSs, if any, in the ATM Offering may be made in sales deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act from time to time. Pursuant to the ATM Offering, the Company received (i) a total gross amount of $30 million from the sale of 11,538,460 Ordinary Shares (underlying 2,307,692 ADSs) on October 6, 2025, (ii) a total gross amount of $30 million from the sale of 10,714,300 Ordinary Shares (underlying 2,142,860 ADSs) on October 29, 2025, and (iii) a total gross amount of $5 million from the sale of 1,700,000 Ordinary Shares (underlying 340,000 ADSs) on November 19, 2025.
Current report
Clinical & Regulatory
Current report
On January 8, 2025, the Company announced positive 3-year results from EPITOPE Phase 3 Open-Label Extension Study, a Phase 3 clinical trial. The EPITOPE OLE data demonstrated continued improvement in treatment benefit of VIASKIN® Peanut patch in toddlers 1 – 3 years through 36 months.
Current report
On March 24, 2025, the Company secured an agreement with FDA on Safety Exposure Data required for BLA for Viaskin® Peanut Patch in 4 – 7-year-olds, accelerating the timeline for a BLA filing to the first half of 2026.
Current report
On June 25, 2025, the Company announced the first subject screened in COMFORT Toddlers Supplemental Safety Study in Peanut Allergic Toddlers 1 – 3 Years Old.
Current report
On November 11, 2025, the Company announced the last‑patient‑last‑visit in the VITESSE Phase 3 clinical trial evaluating the VIASKIN® Peanut patch in peanut‑allergic children aged 4 to 7 years.
Current report
On December 16, 2025, the Company announced positive Topline Results from Phase 3 VITESSE Trial of VIASKIN® Peanut Patch in Peanut Allergic Children Aged 4-7 Years.
Current report
•VITESSE met its primary endpoint: the lower bound of the 95% confidence interval the difference between treatment arms was 24.5%, exceeding the prespecified threshold of 15%.
Current report
•46.6% of children treated with the VIASKIN® Peanut patch met response criteria at 12 months, compared to 14.8% of children in the placebo arm.
Current report
•Safety results were consistent with the safety profile observed in the VIASKIN Peanut clinical program to date.
Current report
•BLA submission in 4-7-year-olds on track for the first half of 2026.
Current report
•Achievement of primary endpoint triggers an acceleration of the exercise period of certain warrants issued pursuant to the 2025 PIPE financing
Current report
The clinical development history of the program is described into Item 1 Business: Our Viaskin Technology Platformof this document.
Current report
Partnerships, Research & Developments.
Current report
The Company relies on various subcontractors to conduct its operations, the principal categories of which include:
Current report
•CROs: These leading international organizations perform, on behalf of the Company, all activities related to regulatory clinical trials once the study protocol has been finalized.
Current report
•CMOs: As the Company does not currently hold the regulatory status of a pharmaceutical establishment, these entities manufacture the batches of patches required for preclinical and clinical development on the Company’s behalf.
Current report
The Company’s dedicated partners also supply the proteins necessary for the manufacture of patches’batches, as well as various patch components and other materials required for production.
Current report
A summary of these agreements is provided in Item 1 Business : Manufacturing and Supplyof this document.
Current report
Governance
Current report
On July 22, 2025, the Company announced the appointment of James Briggs as Chief Human Resources Officer, succeeding Caroline Daniere. James Briggs leads key initiatives supporting DBV’s transition from a development‑stage biotechnology company to a potential commercial‑stage organization.
Current report
On September 18, 2025, the Company announced the resignation of Daniel Soland from his position as a member of the Company’s Board of Directors, effective immediately.
Current report
On October 30, 2025, the Company announced the provisional appointment of a new independent director, Dr. Philina Lee, to its Board of Directors, replacing Daniel Soland, subject to ratification by shareholders at DBV’s next annual shareholder meeting. Dr. Lee also serves as a member of the Board’s Compensation Committee.
Current report
On November 3, 2025, the Company announced the appointment of Kevin Trapp as Chief Commercial Officer, responsible for the global commercial strategy and its execution for the Viaskin Peanut patch.
Current report
F - 71
Current report
Operating Income
Current report
The Company did not generate Revenue from operating activities in 2025 or 2024.
Current report
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 was granted $5.6 million for the year ended December 31, 2025 compared to $4.2 million for the year ended December 31, 2024. The increase is the result of more eligible activities were carried out in the period.
Current report
Research and Development Expenses
Current report
Research and Development expenses increased by $27.3 million for the year ended December 31, 2025 compared to the year ended December 31, 2024.
Current report
The caption Pre-Commercial Inventory of $16.1 million reflects efforts launched by the company in inventory build-up to support commercial readiness in anticipation of potential FDA approval (written down as they do not meet recognition criteria).
Current report
External clinical-related expenses increased by $6.9 million, due to higher clinical trial activity driven by the initiation of patient recruitment for COMFORT Toddlers study. These increases were partially offset by (1) reduced spending on the VITESSE study following completion of final patient visits in 2025 and (2) lower costs from other studies that are completed or nearing completion.
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Removed paragraphs (119)
Previous report
Financial Overview
Previous report
Since our inception, we have primarily funded our operations with equity financings, and, to a lesser extent, public assistance aimed at supporting innovation and payments associated with research tax credit (crédit d’impôt recherche). We do not generate product revenue and continue to prepare for the potential launch of our first product in the United States and in the European Union, if approved.
Previous report
The Company has incurred operating losses and negative cash flows from operations since inception.
Previous report
We imay needadditional capital as we prepare for the launch of Viaskin Peanut, if approved, and continue other research and development efforts. We may seek to finance our future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of non-dilutive financings.
Previous report
We cannot guarantee that we will be able to obtain the necessary financing to meet our needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets resulting from geopolitical instability, macroeconomic conditions, global health crises, or other factors.
Previous report
If we are not successful in our financing objectives, we could have to scale back our operations, notably by delaying or reducing the scope of our research and development efforts or obtain financing through arrangements with collaborators or others that may require us to relinquish rights to our product candidates that we might otherwise seek to develop or commercialize independently.
Previous report
We anticipate that our expenses will increase substantially in connection with our ongoing activities, as we:
Previous report
•continue our research, pre-clinical and clinical development of our product candidates, in particular expanding the scope of our trials for Viaskin Peanut;
Previous report
•seek regulatory and marketing approvals and pursue commercial activities for Viaskin Peanut, primarily in North America and in the European Union;
Previous report
•seek regulatory and marketing approvals for our other product candidates that successfully complete clinical trials;
Previous report
•establish a sales, marketing and distribution infrastructure to commercialize Viaskin Peanut, if approved, and any other products for which we may obtain marketing approval, especially in North America and in the European Union;
Previous report
•further develop the manufacturing process for our product candidates;
Previous report
•change or add additional manufacturers or suppliers;
Previous report
•initiate and conduct any post-approval clinical trials, if required by the FDA or by the EMA, for our approved products, if any;
Previous report
•initiate additional pre-clinical, clinical or other studies for our product candidates;
Previous report
•seek to identify and validate additional product candidates;
Previous report
•acquire or in-license other product candidates and technologies;
Previous report
•make milestone or meet other payments deadlines under any in-license agreements;
Previous report
•maintain, protect and expand our intellectual property portfolio;
Previous report
•attract and retain new and existing skilled personnel;
Previous report
•add operational, financial and management information systems and personnel, including personnel to support our product development and commercialization efforts, as well as a company listed on both the U.S. and French stock markets;
Previous report
•experience any delays or encounter issues with any of the above.
Previous report
The Company has incurred operating losses and negative cash flows from operations since inception. The Company does not generate product revenue and continues to prepare for the potential launch of its first product in the United States and in the European Union, if approved.
Previous report
Since its inception, the Company has primarily funded its operations through equity financings, as well as public assistance and research tax credit. Prior to 2022, the Company underwent restructuring efforts, scaled down certain clinical programs, and engaged with regulatory authorities to advance Viaskin Peanut’s approval process in the United States and European Union. In 2022, the Company secured a private placement financing of $194 million and lifted a partial clinical hold from the FDA on its VITESSE Phase 3 clinical study.
Previous report
Furthermore, should all Warrant Shares be issued, representing potential additional gross proceeds of up to $181.4 million (€168.2 million), the Company estimates that it could extend its financial visibility into 2028, covering the period through the potential commercialization of Viaskin Peanut in the U.S., if approved.
Previous report
Given the Company’s historical operating losses and reliance on external financings, the Company may still seek additional capital for future needs through a combination of public or private equity or debt financings, collaborations, licensing agreements, and other funding options. While recent financing events have improved the Company’s financial position, access to additional capital in the future remains subject to market conditions and investor interest.
Previous report
Business Trends
Previous report
We engage in substantial research and development efforts to develop innovative pharmaceutical product candidates. Research and development expense consists primarily of:
Previous report
•cost of third-party contractors such as contract research organizations, or CROs, that conduct our non-clinical studies and clinical trials;
Previous report
•personnel costs, including salaries, related benefits and share-based compensation, for our employees engaged in scientific research and development functions;
Previous report
•purchases, real-estate leasing costs, as well as conferences and travel costs; and
Previous report
•depreciation, amortization and provisions.
Previous report
Our direct research and development expenses consist principally of external costs, such as startup fees paid to investigators, consultants, central laboratories, and CROs in connection with our clinical trials, and costs related to acquiring and manufacturing clinical study materials. We do not allocate personnel-related costs, costs associated with our general platform improvements, depreciation or other indirect costs to specific programs, as they are deployed across multiple projects under development and, as such, are separately classified as personnel and other expenses.
Previous report
Research and Development activities are central to our business. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect that our Research and Development expenses will continue to increase in the foreseeable future as we initiate clinical trials for certain product candidates and pursue later stages of clinical development of our product candidates.
Previous report
(2)If we exclude MAG1C impact the percentage of research and development expenses related to Viaskin Peanut in 2023 would be 84%.
Previous report
(3)If we exclude MAG1C impact the percentage of research and development expenses related to Viaskin Milk in 2023 would be 8%.
Previous report
We cannot determine with certainty the duration and completion costs of the current or future clinical trials of our product candidates or if, when, or to what extent we will generate revenue from the commercialization and sale of any of our product candidates that obtain regulatory approval. We may never succeed in achieving regulatory approval for any of our product candidates. The duration, costs and timing of clinical trials and development of our product candidates will depend on a variety of factors, many of which are outside of our control including:
Previous report
•the FDA’s approval of our BLA for Viaskin Peanut;
Previous report
•the costs of future commercialization activities, including product sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval, especially in North America;
Previous report
•the costs of securing manufacturing arrangements for commercial production;
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Reworded paragraphs (23)
Previous wording
We are a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin. Our therapeutic approach is based on epicutaneous immunotherapy, or 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.
Current wording
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.
Previous wording
Subsequent to December 31, 2024, the Company raised additional proceeds in a private placement financing (the “2025 PIPE”) consisting of i) a share capital increase without preferential subscription rights reserved to categories of persons satisfying determined characteristics pursuant to the 24th resolution of the general meeting of shareholders of May 16, 2024 (the "2024 General Meeting") completed on April 7 2025 for an amount of €38 million, consisting of the issuance of (i) 34,090,004 new shares at a par value of €0.10 (the "New Shares") each with warrants of the Company attached (the "ABSA Warrants", and together with the New Shares, the "ABSA") at a subscription price of €1.1136 per ABSA and (ii) up to 59,657,507 additional new shares, if all the ABSA Warrants attached to the New Shares are exercised (the "ABSA Warrant Shares"); and ii) the issue through an offering reserved to categories of persons satisfying determined characteristics of 71,005,656 units (the “PFW-BS-PFW”) completed on April 7, 2025 for an amount of €79 million at a subscription price of €1.1136 per PFW-BS-PFW (of which €1.1036 will have been prefunded on the issue date), each PFW-BS-PFW consisting of one pre-funded warrant to subscribe for one share of the Company (the "First Pre-Funded Warrants") and one warrant (the "BS Warrants") to subscribe to one second pre-funded warrants (the "Second Pre-Funded Warrants"), each of which entitles the holder to subscribe for 1.75 shares of the Company (the "Second PFW Shares"), allowing to issue up to 71,005,656 additional new shares if all the First Pre-Funded Warrants are exercised (the "First PFW Shares") and up to 124,259,898 additional new shares if all the Second Pre-Funded Warrants are exercised (the "Second PFW Shares", together with the ABSA Warrant Shares and the First Pre-Funded Warrant Shares, the "Warrant Shares", and together with the New Shares, the "Offered Shares"). The Company received initial net proceeds of $125.5 million (€116.3 million) on April 7, 2025, and based on our current operations, plans and assumptions, we estimate that our balance of cash and cash equivalents will be sufficient to fund our operations into June 2026. We further estimate that, following the potential issuance of all Warrant Shares in the financing, representing potential additional gross proceeds of up to $181.4 million (€168.2 million), we could extend our financial visibility into 2028 and through potential commercialization of Viaskin Peanut in the U.S, if approved.
Current wording
The Company raised proceeds in the 2025 PIPE consisting of i) a share capital increase without preferential subscription rights reserved to categories of persons satisfying determined characteristics pursuant to the 24th resolution of the 2024 General Meeting completed on April 7 2025, for an amount of €38 million ($40 million), consisting of the issuance of (i) 34,090,004 new shares at a par value of €0.10 (the "New Shares") each with warrants of the Company attached (the "ABSA Warrants", and together with the New Shares, the "ABSA") at a subscription price of €1.1136 per ABSA and (ii) up to 59,657,507 additional new shares, if all the ABSA Warrants attached to the New Shares are exercised (the "ABSA Warrant Shares"); and ii) the issue through an offering reserved to categories of persons satisfying determined characteristics of 71,005,656 units (the “PFW-BS-PFW”) completed on April 7, 2025 for an amount of €79 million ($85 million) at a subscription price of €1.1136 per PFW-BS-PFW (of which €1.1036 will have been prefunded on the issue date), each PFW-BS-PFW consisting of one pre-funded warrant to subscribe for one share of the Company (the "First Pre-Funded Warrants") and one warrant (the "BS Warrants") to subscribe to one second pre-funded warrants (the "Second Pre-Funded Warrants"), each of which entitles the holder to subscribe for 1.75 shares of the Company (the "Second PFW Shares"), allowing to issue up to 71,005,656 additional new shares if all the First Pre-Funded Warrants are exercised (the "First PFW Shares") and up to 124,259,898 additional new shares if all the Second Pre-Funded Warrants are exercised (the "Second PFW Shares", together with the ABSA Warrant Shares and the First Pre-Funded Warrant Shares, the "Warrant Shares", and together with the New Shares, the "Offered Shares"). The Company received initial gross proceeds of $125.5 million (€116.3 million) on April 7, 2025.
Previous wording
In May 2022, we established an At-The-Market (“ATM”) program to offer and sell, including with unsolicited investors who have expressed an interest, a total gross amount of up to $100 million of American Depositary Shares (“ADSs”), each ADS representing one-half of one ordinary share of the Company. The ATM program is intended to be effective through the expiration of the Company’s existing registration statement registering the ADSs to be issued under the ATM program, i.e. until July 16, 2024, unless terminated prior to such date in accordance with the sales agreement or the maximum amount of the program has been reached. The Company intent is to use the net proceeds, if any, of sales of ADSs issued under the program, together with its existing cash and cash equivalents, primarily for activities associated with potential approval and launch of Viaskin Peanut, as well as to advance the development of the Company’s product candidates using its Viaskin Platform and for working capital and other general corporate purposes.
Current wording
At-The-Market (ATM) equity program offering
Previous wording
Our Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business.
Current wording
Our Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. All assumptions pertaining to this estimate are detailed below in the Liquidity and Capital Resources discussion.
Previous wording
In the year ended December 31, 2024, we spent $89.3 million in Research and Development expenses to advance the development of our product candidates. The following table provides a breakdown of our direct Research and Development expenses for our two lead development programs, as well as expenses not allocated to the programs and share-based compensation expenses included in Research and Development expenses, for the years ended December 31, 2024 and 2023, respectively:
Current wording
In the year ended December 31, 2025, we spent $116.7 million in Research and Development expenses to advance the development of our product candidates. The following table provides a breakdown of our direct Research and Development expenses for our two lead development programs, as well as expenses not allocated to the programs and share-based compensation expenses included in Research and Development expenses, for the years ended December 31, 2025 and 2024, respectively:
Previous wording
(1)Excludes employee share-based compensation expense after $19.9 million loss on completion accrual reversal as of December 2023.
Current wording
(1)Excludes employee share-based compensation expense
Previous wording
Sales and marketing expense consists primarily of personnel costs, consultant fees and share-based compensation for sales and marketing employees, as well as fees related to pre-commercialization activities for Viaskin Peanut in North America and in the European Union. We anticipate that our sales and marketing expenses will increase significantly in the future as we prepare for the potential launch and commercialization of Viaskin Peanut in North America and in the European Union, if approved.
Current wording
Sales and marketing expense consists primarily of personnel costs, consultant fees and share-based compensation for sales and marketing employees, as well as fees related to pre-commercialization activities for Viaskin Peanut in North America and in the European Union. We anticipate that our sales and marketing expenses will increase significantly in the future as we prepare for the potential launch and commercialization of Viaskin Peanut in North America and in the European Union, if approved. The following table summarizes our sales and marketing expenses for the years presented:
Previous wording
Our financial income was $2.7 million in 2024 and $3.7 million in 2023, and primarily includes the financial income on our financial assets and foreign exchange gains.
Current wording
Our financial income was $0.6 million in 2025 and $2.7 million in 2024, and primarily includes the financial income on our financial assets and foreign exchange gains.
Previous wording
Our income tax expense was $55 thousand for the year ended December 31, 2024, compared to an income tax expense of $7 thousand for the year ended December 31, 2023.
Current wording
Our income tax expense was $491 thousand for the year ended December 31, 2025, compared to an income tax expense of $55 thousand for the year ended December 31, 2024.
Previous wording
Net loss was $113.9 million for the year ended December 31, 2024, compared to $72.7 million for the year ended December 31, 2023. Net loss per share (based on the weighted average number of shares outstanding over the period) was $1.17 and $0.76 for the year ended December 31, 2024 and 2023, respectively.
Current wording
Net loss was $146.9 million for the year ended December 31, 2025, compared to $113.9 million for the year ended December 31, 2024. Net loss per share (based on the weighted average number of shares outstanding over the period) was $1.05 and $1.17 for the year ended December 31, 2025 and 2024, respectively.
Previous wording
On December 31, 2024, we held $32.5 million in cash and cash equivalents compared to $141.4 million of cash and cash equivalents on December 31, 2023. Net cash used for operating activities was $104.5 million and $79.7 million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, we recorded a net loss of $113.9 million. Our net cash flows provided by financing activities totaled $0.6 million in 2024 and $6.8 million in 2023, mainly consisting of the proceeds from our ATM program.,
Current wording
On December 31, 2025, we held $194.2 million in cash and cash equivalents compared to $32.5 million of cash and cash equivalents on December 31, 2024. Net cash used for operating activities was $121.2 million and $104.5 million for the years ended December 31, 2025 and 2024, respectively. In the year ending December 31, 2025, we recorded a net loss of $146.9 million. Our net cash flows provided by financing activities totaled $276.2 million in 2025 and $0.6 million in 2024, mainly consisting of the proceeds from the 2025 PIPE and sales from our ATM program.
Previous wording
The research tax credit (crédit d’impôt recherche, or CIR) is granted to companies by the French tax authorities in order to encourage them to conduct technical and scientific research. Companies that prove that they have expenditures that meet the required criteria receive a tax credit that can be used for the payment of the corporate tax due for the fiscal year in which the expenditures were made and the next three fiscal years, or, as applicable, can be reimbursed for the excess portion. The expenditures taken into account for the calculation of the research tax credit involve only research expenses.
Current wording
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.
Previous wording
The commitment amounts in the table above are associated with contracts that are enforceable and legally binding and that specify all significant terms, including interest on long-term debt, fixed or minimum services to be used, fixed, minimum or variable price provisions, and the approximate timing of the actions under the contracts. The table does not include obligations under agreements that we can cancel without a significant penalty.
Current wording
The commitment amounts in the table above are associated with contracts that are enforceable and legally binding and that specify all significant terms, including fixed or minimum services to be used, fixed, minimum or variable price provisions, and the approximate timing of the actions under the contracts. The table does not include obligations under agreements that we can cancel without a significant penalty.
Previous wording
On April 7, 2025, the Company received gross proceeds of $125.5 million (€116.3 million) from the issuance of the ABSA and PFW-BS-PFW, as described in Note 20. With the receipt of the aforementioned proceeds, and based on its current operations, plans, and assumptions examined by the Board on March 23, 2025, the Company estimates that its cash and cash equivalents are sufficient to fund its operations into June 2026.
Current wording
As a result of the proceeds received from the subsequent exercise of the ABSA and BS warrants of $94 million (€81 million) and with existing cash and cash equivalents as of December 31, 2025 of $194 million, management has determined that the Company has sufficient liquidity to fund its operations for at least twelve months from the date of issuance of this Form 10‑K and that the conditions that previously raised substantial doubt about the Company’s ability to continue as a going concern are no longer present. With the receipt of the aforementioned proceeds, and based on its current operations, plans, and assumptions, the Company estimates that its cash and cash equivalents are sufficient to fund its operations into the second quarter of 2027.
Previous wording
Our net cash flows used in investing activities were $0.8 million in 2024 and $0.8 million in 2023.
Current wording
Our net cash flows used in investing activities were $1.4 million in 2025 and $0.8 million in 2024.
Previous wording
Our financial statements are prepared in accordance with U.S. GAAP. Some of the accounting methods and policies used in preparing our financial statements under U.S. GAAP are based on complex and subjective assessments by our management or on estimates based on past experience and assumptions deemed realistic and reasonable based on the facts and circumstances concerned. The actual value of our assets, liabilities and shareholders’ equity and of our earnings could differ from the value derived from these estimates if conditions changed and these changes had an impact on the assumptions adopted. We believe that the most significant management judgments and assumptions in the preparation of our financial statements are described below. See Note 1 to our financial statements for a description of our other significant accounting policies.
Current wording
Our financial statements are prepared in accordance with U.S. GAAP. Some of the accounting methods and policies used in preparing our financial statements under U.S. GAAP are based on complex and subjective assessments by our management or on estimates based on past experience and assumptions deemed realistic and reasonable based on the facts and circumstances concerned. The actual value of our assets, liabilities and shareholders’ equity and of our earnings could differ from the value derived from these estimates if conditions changed and these changes had an impact on the assumptions adopted. We believe that the most significant management judgments and assumptions in the preparation of our financial statements are described in Note 1 to our financial statements for a description of our other significant accounting policies.
Previous wording
We have several share-based compensation plans for employees and non-employees. We account for share-based compensation in accordance with the authoritative guidance on share-based compensation. Under the fair value recognition provisions of this guidance, share-based compensation is measured at the grant date based on the fair value of the award and is recognized as expense, net of estimated forfeitures, over the requisite service period, which is generally the vesting period of the respective award.
Current wording
Equity awards are measured at grant‑date fair value and recognized as compensation expense, net of estimated forfeitures, over the requisite service period, which generally corresponds to the vesting period of the respective awards.
Previous wording
Determining the fair value of the share-based payments at the grant date requires judgment. We calculated the fair value of stock options on the grant date using the Black-Scholes option pricing model. The Black-Scholes model requires the input of highly subjective assumptions, including the expected volatility, expected term, risk-free interest rate and dividend yield.
Current wording
The fair value of stock options is estimated at the grant date using the Black‑Scholes option pricing model, which requires management to make a number of highly subjective assumptions, including expected volatility, expected term, risk‑free interest rate and expected dividend yield. These assumptions are inherently uncertain and require significant judgment.
Previous wording
The exercise price of our stock options is based on the fair market value of our ordinary shares.
Current wording
•Exercise price of stock options is based on the fair market value of the Company’s ordinary shares at the grant date.
Previous wording
The risk-free interest rate is based on French government bonds (GFRN) with a maturity corresponding to the maturity of the share options.
Current wording
•Risk‑free interest rate is determined using French government bonds (GFRN) with a maturity corresponding to the expected term of the stock options.
Previous wording
We determine the expected term based on the average period the stock options are expected to remain outstanding.
Current wording
•Expected term represents the period over which stock options are expected to remain outstanding and is determined based on the average expected life of the options, taking into account vesting conditions and historical exercise behavior.
Previous wording
We have never declared or paid any cash dividends and we do not presently plan to pay cash dividends in the foreseeable future. Consequently, we use an expected dividend yield of zero.
Current wording
•Expected dividend yield: The Company has never declared or paid cash dividends and does not currently intend to pay cash dividends in the foreseeable future. Accordingly, an expected dividend yield of zero is used in the valuation of stock options.
Previous wording
In connection with the launch of our clinical trials for Viaskin Peanut and Viaskin Milk, we signed agreements with several contract research organizations. As of December 31, 2024, expenses associated with the ongoing trials amounted globally to $170.3 million, and we had non-cancellable contractual obligations with CRO until the year ended 2026 amounting to $10.0 million.
Current wording
In connection with the launch of our clinical trials , we signed agreements with several CROs. As of December 31, 2025, expenses associated with the ongoing trials amounted globally to $32.7 million, and we had non-cancellable contractual obligations with CRO until the year ended 2027 amounting to $48.6 million.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
The following table summarizes our sales and marketing expenses for the years presented: