DBV Technologies S.A.: Form 10-Q for the period ended Sep 30, 2025
Filed with the SEC on Oct 28, 2025 and accepted by EDGAR at Oct 28, 2025, 16:44 ET.
Management's discussion and analysis
As filed, 38,092 characters, with its headings, lists and tables. Extracted from the main document; charts and exhibits are in the original on sec.gov.
You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed consolidated financial statements and related notes included in Part 1, Item 1 of this Report and with our audited financial statements and related notes thereto for the year ended December 31, 2024, included in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on April 11, 2025, as amended by Amendment No. 1 on Form 10-K/A filed with the SEC on April 28, 2025, and as amended further by Amendment No. 2 on Form 10-K/A filed with the SEC on May 14, 2025, or the Annual Report. This discussion and other parts of this Report contain forward-looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations and intentions. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause such differences are discussed in the section of this Report titled “Special Note Regarding Forward-Looking Statements” and under “Item 1A. Risk Factors” in the Annual Report.
Overview
We are a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin. Our therapeutic approach is based on epicutaneous immunotherapy (EPIT) our proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin, an epicutaneous patch (i.e., a skin patch). We have generated significant data demonstrating that Viaskin’s mechanism of action is novel and differentiated, Viaskin targets specialized antigen-presenting immune cells in the skin, called Langerhans cells, that capture the antigen that accumulates in the outer layer of the skin, and then migrate to the skin-draining lymph nodes in order to activate the immune system without passage of the antigen into the bloodstream, minimizing systemic exposure in the body. We are advancing this unique technology to treat children suffering from food allergies, for whom safety is paramount, since the introduction of the offending allergen into their bloodstream can cause severe or life-threatening allergic reactions, such as anaphylactic shock. We believe Viaskin may offer convenient, self-administered, non-invasive immunotherapy to patients, if approved.
Our most advanced product candidate is the Viaskin Peanut patch, evaluated as a potential immunotherapy for children with peanut allergy in eleven clinical trials, including four Phase 2 trials and four completed Phase 3 trials. We are advancing two separate Viaskin Peanut product candidates in parallel to support two potential Biologics License Applications (BLAs) in two distinct age groups: one in toddlers ages one through three with the original (square) patch, and one in children ages four through seven with the modified (circular) patch.
Currently, we have an ongoing Phase 3 efficacy and safety trial (VITESSE) to evaluate the modified Viaskin Peanut patch in children ages four through seven with peanut allergy. On March 7, 2023, the Company announced that the first subject was screened in the VITESSE study. The Company announced on September 23, 2024 that subject screening was completed in the third quarter of 2024. Topline results are anticipated in the fourth quarter of 2025. On March 24, 2025, the Company announced that in a Written Responses Only to the Company’s Type D IND meeting request the FDA agreed with the Company’s proposal that the safety exposure data from the VITESSE Phase 3 study for Viaskin peanut patch in 4 – 7-year-olds will be sufficient to support a BLA filing in this age group. As a result, the COMFORT Children supplemental safety study will no longer be required and the Company will not conduct the study. The Company will utilize the safety data from the VITESSE subjects randomized to active treatment as well as placebo-crossover subjects in the VITESSE Open Label Extension (OLE). Accordingly, the Company plans to submit a BLA in the first half of 2026 and anticipates potentially accelerating the product launch by approximately one year, subject to FDA approval.
We also have an ongoing Phase 3 open-label extension to the EPITOPE trial (our completed Phase 3 efficacy and safety trial conducted in peanut-allergic toddlers which met its clinical endpoints), with 3-year results for active-treatment subjects in 2024, and an ongoing Phase 3 supplementary safety study, in peanut-allergic toddlers ages one through three.
The Company submitted the protocol for its COMFORT Toddlers supplemental safety study in 1 – 3 years-old to the FDA on November 9, 2023. The Company received comments and queries to the protocol from the FDA on March 11, 2024. On July 30, 2024, the Company announced that it and the FDA had been engaged in ongoing dialogue since May 2023 on the COMFORT Toddlers supplemental safety study in 1 – 3-years-old with a peanut allergy. The study protocol was submitted on November 9, 2023, with comments provided by FDA on March 11, 2024. After March, much of the dialogue between DBV and FDA regarding the COMFORT Toddlers supplemental study had focused on patch wear-time experience, including how prescribers would advise parents and caregivers to manage day-to-day variability in patch wear time. The Company proposed an approach, informed by the EPITOPE efficacy data, that focuses on the user experience during the first 90-days of treatment. The Company submitted to the FDA draft labeling for Section 2 – Dosing and Administration, for a potential Viaskin Peanut Prescribing Information (PI), along with comprehensive supportive data and analyses. Within the first 90-days of treatment (excluding the lead-in dosing period) it is possible to identify those patients who are very likely to have a robust clinical efficacy response based on patch wear time experience (i.e., “Label-in” patients). The proposed PI recommends continuation of treatment for these patients. With the same 90-day approach, patients less likely to have a robust clinical efficacy response, identified by their patch wear-time experience, would be identified as “Label-out” patients. In these instances, the PI would recommend a shared decision-making process, between the health care provider and the parent or caregiver, to determine whether treatment should be discontinued.
On October 22, 2024, the Company announced positive regulatory updates for the Viaskin Peanut patch in the United States and Europe. DBV agreed to guidance provided by the FDA on a potential pathway under the Accelerated Approval Program for the Viaskin Peanut patch in toddlers ages 1 – 3 years-old. FDA confirmed that the Company met Accelerated Approval qualifying criterion 1 and 2 . Regarding criterion 3, FDA provided guidance and suggestion regarding the intermediate clinical endpoint, which the Company agreed to in informal discussions with the FDA. The Company formalized the Accelerated Approval guidance provided by FDA via submission of a meeting request and confirmed the general elements of the two study components: the COMFORT Toddlers safety study, to be completed before BLA submission, and the confirmatory effectiveness study, including the third Accelerated Approval criterion regarding the intermediate clinical endpoint. The Company expects that the confirmatory study will be initiated by the time of BLA submission and would run in parallel to commercialization in the United States, if the Viaskin Peanut patch is approved.
The Company announced further that it aligned with FDA on a wear time collection methodology in COMFORT Toddlers that provides a practical approach for subjects and families, is intended to generate sufficient data to support a BLA submission, and places wear time into an acceptable clinical hierarchy relative to other study endpoints. On June 25, 2025, the Company announced that the first subject was screened in COMFORT Toddlers supplemental safety study in peanut allergic toddlers 1 – 3 years old. The Company anticipates enrolling approximately 300 – 350 subjects on active treatment into the safety study, which would bring the total Viaskin Peanut patch safety database in toddlers to approximately 600 subjects, consistent with prior FDA guidance. With this path forward, the BLA submission for Viaskin Peanut patch in 1 – 3 years-old under the Accelerated Approval program is anticipated to be supported by:
i. Positive efficacy and safety data from DBV’s previously completed EPITOPE Phase 3 Study; and
ii. Additional safety data generated in COMFORT Toddlers supplemental safety study, which was initiated in June quarter of 2025.
On December 11, 2024, the Company announced that it reached alignment with FDA on the Accelerated Approval pathway for Viaskin Peanut patch in toddlers 1-3 years-old and on key study design elements for the COMFORT Toddlers study, including study size and wear time collection methodology and analysis. The Company announced further that FDA confirmed criteria for a post-marketing confirmatory study in toddlers 1-3 years-old and that the Company and FDA agreed that the confirmatory study will assess the effectiveness of the intended commercial Viaskin Peanut patch, will include a include a double-blind, placebo-controlled food challenge (DBPCFC) and will use the same statistical criteria for success (i.e., lower bound of the 95% CI > 15%) as used in the EPITOPE and will need to be initiated at the time that the BLA is submitted.
On June 25, 2025, the Company announced that the first subject was screened in COMFORT Toddlers supplemental safety study in peanut allergic toddlers 1 – 3 years old.
The Company announced further that it sought scientific advice from the EMA regarding the components of a MAA for the Viaskin Peanut patch. Previous advice obtained from two local country regulatory health authorities indicated a potential path for a 1 – 7 year-old registration with one patch, the modified patch. The EMA recently confirmed through scientific advice that the completed EPITOPE study in 1 – 3 years-old, and a positive VITESSE study in 4 – 7 years-old, could constitute an MAA submission for a 1 – 7 year-old indication for peanut allergy patients using the modified patch, along with a new safety study in 1 – 3 years-old with the modified patch. Timing for the initiation of this new safety study to satisfy the important EU market is currently being planned.
Critical Accounting Policies and Significant Judgments and Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”). The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements, as well as the revenue, costs and expenses recognized during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
There have been no new policies or significant changes to our critical accounting policies as disclosed in the critical accounting policies described in the Annual Report. Our significant accounting policies are more fully described in Note 1 of the Notes to the Consolidated Financial Statements in Part I, Item 1 of our Annual Report.
Manufacturing and Supply Agreement
On August 29, 2025, the Company updated the Supply Agreement with SANOFI, under which SANOFI will manufacture and supply the Viaskin Peanut API exclusively for the Company during the term of the Supply Agreement. The Supply Agreement has an initial term of four years with a possibility to extend for an additional period. The effective date of the Supply Agreement is January 1, 2025.
The Supply Agreement includes terms related to manufacturing, quality control, pricing, volume commitments, and supply obligations. The Supply Agreement is designed to secure commercial-scale manufacturing capacity in preparation for a potential Biologics License Application (“BLA”) submission and subsequently, the commercial launch of the Viaskin Peanut patch in the United States, if approved.
We have non-cancellable minimum commitments for products and services, subject to the Supply Agreement. Under US GAAP, take-or-pay arrangements are generally considered firm purchase commitments. As of September 30, 2025, we have assessed our ability to meet our performance obligations as per US GAAP requirements (ASC 440-10: Commitments, ASC 450-20: Loss Contingencies and ASC 330-10-35: Inventory and purchase commitments) and confirm to commit to agreed volumes. Hence, we have not recognized on the balance sheet any loss provision.
The Company expects to incur expenditures related to support for BLA and PAI preparation, Cold storage rental, over the Supply Agreement term. These expenditures are consistent with the Company’s planned investments to strengthen its supply chain readiness ahead of potential regulatory milestones. The Company believes the Supply Agreement enhances the robustness of its manufacturing network and supports long-term product supply reliability.
Business Trends and Results of Operations
Comparison of the Three Months Ended September 30, 2025 and 2024
The following table summarizes our results of operations, derived from our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in thousands of U.S. dollars, for the three months ended September 30, 2025 and 2024.
| 2025 | Three Months Ended September 30, 2024 | $ change | % of change | |
|---|---|---|---|---|
| Operating income | 2,774 | 1,072 | 1,702 | 159% |
| Operating expenses | ||||
| Research and development expenses | (28,615) | (23,662) | (4,953) | 21% |
| Sales and marketing expenses | (1,178) | (519) | (659) | 127% |
| General and administrative expenses | (7,259) | (7,220) | (38) | 1% |
| Total Operating expenses | (37,051) | (31,401) | (5,650) | 18.0% |
| Financial income (expense) | 1,113 | (113) | 1,226 | (1084)% |
| Income tax | — | — | — | — |
| Net loss | (33,164) | (30,442) | (2,723) | 9% |
Operating Income
The following table summarizes our operating income during the three months ended September 30, 2025 and 2024:
| 2025 | Three Months Ended September 30, 2024 | $ change | % of change | |
|---|---|---|---|---|
| Other income | 2,774 | 1,072 | 1,702 | 159% |
| Research tax credit | 2,774 | 1,072 | 1,702 | 159% |
| Total operating income | 2,774 | 1,072 | 1,702 | 159% |
Research tax credit increased by $1.7 million for the three months ended September 30, 2025, compared to the three months ended September 30, 2024 primarily due to a greater proportion of activities eligible to receive the Research tax credit carried out in the third quarter 2025 than in the third quarter 2024.
Operating Expenses
Research and Development Expenses
The following table summarizes our research and development expenses incurred during the three months ended September 30, 2025 and 2024:
| Research and Development expenses 2025 | Three Months Ended September 30, 2024 | $ change | % of change | |
|---|---|---|---|---|
| External clinical-related expenses | 21,727 | 17,216 | 4,511 | 26% |
| Employee-related costs | 4,795 | 4,300 | 495 | 12% |
| Share-based payment expenses | 415 | 726 | (311) | (43)% |
| Depreciation, amortization and other costs | 1,677 | 1,419 | 258 | 18% |
| Total Research and Development expenses | 28,615 | 23,662 | 4,953 | 21% |
Research and Development expenses increased by $5.0 million for the three months ended September 30, 2025 compared to the three months ended September 30, 2024.
External clinical-related expenses increased by $4.5 million mainly due to (1) the launch of the COMFORT Toddlers study following alignment with the FDA, and (2) regulatory and production activities to support ongoing clinical trials, BLA submission and pre-commercialization activities for Viaskin Peanut in North America.
Employee-related costs increased by $0.5 million for the three months ended September 30, 2025 compared to the three months ended September 30, 2024. This increase is mainly due to (1) recruitments made during the third quarter of 2024, mainly based in the United States, for which a full quarter of personnel costs are recognized at end-September 2025, and (2) additional recruitments made during the third quarter 2025.
Depreciation, amortization and other costs remain consistent for the three months ended September 30, 2025 compared to the three months ended September 30, 2024.
Sales and Marketing Expenses
The following table summarizes our sales and marketing expenses incurred during the three months ended September 30, 2025 and 2024:
| Sales & Marketing expenses 2025 | Three Months Ended September 30, 2024 | $ change | % of change | |
|---|---|---|---|---|
| External professional services | 497 | 187 | 310 | 166% |
| Employee-related costs | 214 | 114 | 100 | 87% |
| Share-based payment expenses | 17 | 30 | (12) | (41)% |
| Depreciation, amortization and other costs | 449 | 188 | 261 | 139% |
| Total Sales & Marketing expenses | 1,178 | 519 | 659 | 127% |
Sales and marketing expenses have increased by $0.7 million during the three months ended September 30, 2025, compared to the three months ended September 30, 2024 mainly due to higher Sales and Marketing activities to prepare support pre-commercialization activities for Viaskin Peanut in North America.
General and Administrative Expenses
The following table summarizes our general and administrative expenses incurred during the three months ended September 30, 2025 and 2024:
| General & Administrative expenses 2025 | Three Months Ended September 30, 2024 | $ change | % of change | |
|---|---|---|---|---|
| External professional services | 2,765 | 2,579 | 186 | 7% |
| Employee-related costs | 2,236 | 2,307 | (71) | (3)% |
| Share-based payment expenses | 83 | 835 | (752) | (90)% |
| Depreciation, amortization and other costs | 2,175 | 1,499 | 676 | 45% |
| Total General & Administrative expenses | 7,259 | 7,220 | 39 | 1% |
General and Administrative expenses remain consistent for the three months ended September 30, 2025, compared to the three months ended September 30, 2024.
External professional services increased by $0.2 million for the three months ended September 30, 2025, compared to the three months ended September 30, 2024 mainly due to financing activities.
Employee-related costs, excluding share-based payments, decreased by $0.1 million for the three months ended September 30, 2025, compared to the three months ended September 30, 2024 due to lower full time equivalent on third quarter 2025 compared to 2024.
The Share-based payment expenses decreased by $0.8 million mainly due to employees that lost their rights subsequently to their exits.
Depreciation, amortization and other costs increased by $0.7 million for the three months ended September 30, 2025, compared to the three months ended September 30, 2024 mainly due to depreciation related to the refurbishment of the Châtillon office and licenses increase following recruitment made in 2025.
Financial Income (Expense)
Our financial income was $1.1 million for the three months ended September 30, 2025, compared to a financial expense of $0.1 million for the three months ended September 30, 2024. This item mainly includes the gains from our investments.
Income Tax
Our income tax was nil for the three months ended September 30, 2025 and September 30, 2025.
Net Loss
Net loss was $33.2 million for the three months ended September 30, 2025, compared to $30.4 million for the three months ended September 30, 2024. Net loss per share (based on the weighted average number of shares outstanding over the period) was $ (0.24) and $ (0.32) for the three months ended September 30, 2025 and 2024, respectively.
Comparison of the Nine Months Ended September 30, 2025 and 2024
The following table summarizes our results of operations, derived from our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in thousands of U.S. dollars, for the nine months ended September 30, 2025 and 2024.
| 2025 | Nine Months Ended September 30, 2024 | $ change | % of change | |
|---|---|---|---|---|
| Operating income | 4,991 | 3,640 | 1,351 | 37% |
| Operating expenses | ||||
| Research and development expenses | (83,790) | (70,438) | (13,352) | 19% |
| Sales and marketing expenses | (1,858) | (2,263) | 404 | (18)% |
| General and administrative expenses | (21,348) | (23,667) | 2,320 | (10)% |
| Total Operating expenses | (106,997) | (96,368) | (10,628) | 11% |
| Financial income (expense) | 4 | 1,873 | (1,869) | (100)% |
| Income tax | (117) | (48) | (69) | 143% |
| Net loss | (102,118) | (90,903) | (11,215) | 12% |
Operating Income
The following table summarizes our operating income during the nine months ended September 30, 2025 and 2024:
| 2025 | Nine Months Ended September 30, 2024 | $ change | % of change | |
|---|---|---|---|---|
| Other income | 4,991 | 3,640 | 1,351 | 37% |
| Research tax credit | 4,991 | 3,640 | 1,351 | 37% |
| Total operating income | 4,991 | 3,640 | 1,351 | 37% |
During the nine months ended September 30, 2025 we generated an Operating Income of $5.0.million compared to $3.6.million during the nine months ended September 30, 2025.
Research tax credit increased by $1.4 million for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024 primarily due to the fact that more eligible activities have been carried out in the period, including the related costs of the FAREVA platform.
Operating Expenses
Research and Development Expenses
The following table summarizes our R&D expenses incurred during the nine months ended September 30, 2025 and 2024:
| Research and Development expenses 2025 | Nine Months Ended September 30, 2024 | $ change | % of change | |
|---|---|---|---|---|
| External clinical-related expenses | 61,192 | 49,708 | 11,484 | 23% |
| Employee-related costs | 13,998 | 13,059 | 939 | 7% |
| Share-based payment expenses | 1,539 | 2,192 | (652) | -30% |
| Depreciation, amortization and other costs | 7,060 | 5,479 | 1,581 | 29% |
| Total Research and Development expenses | 83,790 | 70,438 | 13,352 | 19.0% |
Research and Development expenses increased by $13.4 million for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024.
External clinical-related expenses increased by $11.5 million mainly due to (1) the launch of the COMFORT Toddlers study following alignment with the FDA and (2) regulatory and production activities to support ongoing clinical trials, BLA submission and pre-commercialization activities for Viaskin Peanut in North America.
Employee-related costs increased by $0.9 million for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. This increase is primarily due to the recruitment carried out during the second quarter of 2024, mainly based in the United States in Medical, Quality and Regulatory Affairs, resulting in a full nine-month impact in 2025 compared to a four to six month impact in 2024.
Depreciation, amortization and other costs increased by $1.6 million for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. This increase is mainly due to a $1.1 million provision reversal at June 30, 2024, following the termination of the Collaboration Agreement with NESTEC, which reduced last year's charge.
Sales and Marketing expenses
The following table summarizes our sales and marketing expenses incurred during the nine months ended September 30, 2025 and 2024:
| Sales & Marketing expenses 2025 | Nine Months Ended September 30, 2024 | $ change | % of change | |
|---|---|---|---|---|
| External professional services | 755 | 754 | 1 | 0.1% |
| Employee-related costs | 527 | 640 | (114) | -17.8% |
| Share-based payment expenses | 55 | 91 | (36) | -39.8% |
| Depreciation, amortization and other costs | 522 | 777 | (255) | -32.9% |
| Total Sales & Marketing expenses | 1,858 | 2,263 | (404) | -17.9% |
Sales and Marketing expenses decreased by $0.4 million for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024, mainly due to (1) lower Sales and Marketing activities, (2) lower sales full time equivalent (following a transfer of assignment between sales and overheads) and (3) lower travel expenses.
General and Administrative expenses
The following table summarizes our general and administrative expenses incurred during the nine months ended September 30, 2025 and 2024:
| General & Administrative expenses 2025 | Nine Months Ended September 30, 2024 | $ change | % of change | |
|---|---|---|---|---|
| External professional services | 6,370 | 8,173 | (1,804) | -22.1% |
| Employee-related costs | 7,354 | 7,001 | 354 | 5.1% |
| Share-based payment expenses | 1,869 | 2,791 | (922) | -33.0% |
| Depreciation, amortization and other costs | 5,755 | 5,703 | 52 | 0.9% |
| Total General & Administrative expenses | 21,348 | 23,667 | (2,320) | -9.8% |
General and Administrative expenses decreased by $2.3 million for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024.
This decrease derives from decrease in external professional services due to non-recurring costs incurred in 2024 associated with (1) office relocations in France and the United States, (2) financing activities and (3) activities related to the Company's and patents.
Employee-related costs increased by $0.4 million for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024. This increase is primarily due to recruitment having started during the second quarter of 2024.
Depreciation, amortization and other costs remain consistent for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024.
Financial income (expense)
Our financial income was $4 thousand for the nine months ended September 30, 2025, compared to a financial income of $1.9 million for the nine months ended September 30, 2024. This item includes the net interests yielded by our cash deposits offset by an unfavorable foreign exchange impact.
Income tax
Our income tax expense was $117 thousand for the nine months ended September 30, 2025, compared to $48 thousand for the nine months ended September 30, 2024.
Net loss
Net loss was $102.1 million for the nine months ended September 30, 2025, compared to $90.9 million for the nine months ended September 30, 2024. Net loss per share (based on the weighted average number of shares outstanding over the period) was $(0.82) and $(0.95) for the nine months ended September 30, 2025 and 2024, respectively.
Liquidity and Capital Resources
Financial Condition
On September 30, 2025, we had $69.8 million in cash and cash equivalents compared to $32.5 million of cash and cash equivalents on December 31, 2024.
On March 27, 2025, the Company announced the 2025 financing (PIPE), as further described below, of up to $306.9 million (€284.5 million), to advance Viaskin® Peanut Patch through BLA submission and U.S. commercial launch, if approved.
On April 7, 2025, the Company received gross proceeds of $125.5 million (€116.3 million) from the issuance of securities including, ABSAs and PFW-BS-PFWs, as described in the Company’s Quarterly Report on Form 10-Q for the Quarter ended March 31, 2025 filed with the SEC on April 30, 2025.
The Company may also receive an aggregate of up to $181.4 million (€168.2 million) in gross proceeds if all warrants are exercised, subject to satisfaction of specified conditions. The VITESSE Phase 3 study hitting its primary endpoint will trigger an acceleration of the exercise period of the warrants. DBV expects that the proceeds of this funding will be used for working capital and general corporate purposes, to finance the continued development of the Viaskin Peanut program, to finance the preparation and submission of a potential Biologics License Application (“BLA”) and, to finance the readiness of a launch of Viaskin peanut in the US, if approved.
In September 2025, the Company entered into a Sales Agreement (the “Sales Agreement”) with Citizens JMP Securities, LLC (“Citizens”), with respect to an equity offering program (the “ATM Offering”) pursuant to which the Company may offer sell American Depositary Shares (“ADS”), from time to time, through Citizens as its sales agent. Pursuant to the Sales Agreement and a prospectus supplement the Company has filed related to the ATM Offering, the Company may offer and sell ADSs having an aggregate offering price of up to $150.0 million (subject to French regulatory limits) from time to time through Citizens. The issuance and sale, if any, of the ADSs by the Company under the Sales Agreement will be made pursuant to the Company’s previously filed and effective registration statement on Form S-3 (Registration Statement No. 333-271166). Sales of the Company’s ADSs, if any, in the ATM Offering may be made in sales deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act from time to time. Subsequent to the end of the third quarter, the Company also received a total gross amount of approximately $30 million from the sale of 11,538,460 Ordinary Shares (underlying 2,307,692 ADSs) received on October 6, 2025 pursuant to the ATM Offering.
As of the date of the filing, with the receipt of the aforementioned proceeds, and based on its current operations, plans, and assumptions examined by the Board on October 28, 2025, the Company estimates that its cash and cash equivalents are sufficient to fund its operations into the third quarter of 2026. These conditions and events raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that these financial statements are issued.
Sources of Liquidity and Material Cash Requirements
We have incurred net losses each year since our inception. Substantially all of our net losses resulted from costs incurred in connection with our development programs and from general and administrative expenses associated with our operations. We have not incurred any bank debt.
We may seek additional capital as we prepare for the launch of the Viaskin Peanut patch, if approved, and continue other research and development efforts. We may seek to finance our future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of non-dilutive financings.
We cannot guarantee that we will be able to obtain the necessary financing to meet our needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets due any future pandemics, epidemics or global health crises and conflicts, other global political or military crises. A severe or prolonged economic downturn could result in a variety of risks to us, including reduced ability to raise additional capital when needed or on acceptable terms, if at all. If we are not successful in our financing objectives, we could have to scale back our operations, notably by delaying or reducing the scope of our research and development efforts or obtain financing through arrangements with collaborators or others that may require us to relinquish rights to our product candidates that we might otherwise seek to develop or commercialize independently.
Operating Leases
There have been no material changes in our operating leases from those disclosed in the Annual Report.
Purchase Obligations - Obligations Under the Terms of CRO Agreements
In preparation of the launch of our clinical trials for Viaskin Peanut, we signed agreements with several contract research organizations. As of September 30, 2025 expenses associated with the ongoing trials amounted globally to $279.2 million compared to $170.3 million as of December 31, 2024.
This increase is mainly due to the launch of the COMFORT Toddlers study following alignment with the FDA, and the progress of the VITESSE phase 3 clinical study.
Purchase Obligations - Obligations Under the Terms of SANOFI Manufacturing and Supply Agreement
We have non-cancellable minimum commitments for products and services, subject to the Supply Agreement. They are reflected in Note 12.
Summary Statement of Cash Flows
The table below summarizes our sources and uses of cash for the nine months ended September 30, 2025 and 2024.
(Amounts in thousands of U.S. Dollars)
| Nine Months Ended September 30, 2025 | 2024 | $ change | % of change | |
|---|---|---|---|---|
| Net cash flow used in operating activities | (86,008) | (92,222) | 6,214 | (7)% |
| Net cash flow used in investing activities | (654) | (1,550) | 896 | (58)% |
| Net cash flows used in / provided by financing activities | 117,122 | (88) | 117,210 | (132641)% |
| Effect of exchange rate changes on cash and cash equivalents | 6,921 | (1,065) | 7,987 | (750)% |
| Net (decrease) increase in cash and cash equivalents | 37,381 | (94,925) | 132,307 | (139)% |
Operating Activities
Our net cash flows used in operating activities were $86.0 million and $92.2 million during the nine months ended September 30, 2025 and 2024, respectively. Our net cash flows used in operating activities decreased by $6.2 million as our costs and expenses have been contained and payment terms extended during period covered by this report.
The decrease compared to last year is mainly due to (1) the deferral of Research & Development activities to support clinical trial progress through regulatory affairs, medical affairs, the manufacturing platform and procurement activities for $6.8 million, (2) General and Administration non-recurring costs incurred in 2024 associated with office relocations in France and the United States, financing activities, activities related to the Company's trademarks and patents and savings on insurance policies for $5.0 million, and (3) deferrals of Sales & Marketing activities by $0.8 million. This decrease is partially offset by the launch of the COMFORT Toddlers study following alignment with the FDA for $4.7 million.
Investing Activities
Our net cash flows used in investing activities were $0.7 million and $1.5 million during the nine months ended September 30, 2025 and 2024 respectively. The variance is primarily explained by capitalized costs for the headquarters move to Châtillon.
Financing Activities
Our net cash flows from financing activities were $117.1 million for the nine months ended September 30, 2025 compared to $(88) thousand for the nine months ended September 30, 2024. This increase is due to the financing operation completed on April 7, 2025.
Off-Balance Sheet Arrangements
On August 29, 2025, the Company updated its Supply Agreement with SANOFI, under which SANOFI will manufacture and supply the Viaskin Peanut API exclusively for the Company during the Supply Agreement term. Under such, the Company has agreed to certain minimum purchase levels and service fees over the initial four-year-term.
As of September 30, 2025, total payments made during the period under the Agreement are approximately $5.9 million, which were recorded as R&D expenses.
Future purchase commitments as of September 30, 2025, are as follows and are consistent with the Company’s overall manufacturing and supply strategy in preparation for potential commercial launch activities.
in thousands USD
| 2025 | 2026 | 2027 | 2028 | Total | |
|---|---|---|---|---|---|
| Commitments | 12,313 | 14,687 | 12,751 | 4,827 | 44,578 |
26
Smaller Reporting Company Status
We are a smaller reporting company as defined in the Securities Exchange Act of 1934, as amended. We may, and intend to, take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as we are a smaller reporting company. We may be a smaller reporting company in any year in which (i) the market value of our voting and non-voting ordinary shares held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter or (ii) (a) our annual revenue is less than $100.0 million during the most recently completed fiscal year and (b) the market value of our voting and non-voting ordinary shares held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.
Market risk
As filed, 153 characters, with its headings, lists and tables. Extracted from the main document; charts and exhibits are in the original on sec.gov.
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.
Controls and procedures
As filed, 2,835 characters, with its headings, lists and tables. Extracted from the main document; charts and exhibits are in the original on sec.gov.
Disclosure Controls and Procedures
Based on its evaluation as of September 30, 2025, our management, including our Chief Executive Officer and Chief Financial Officer, concluded that our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act) were effective to provide reasonable assurance that (i) the information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and (ii) such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting identified in management’s evaluation pursuant to Rules 13a-15(d) or 15d-15(d) of the Exchange Act during the period covered by this Quarterly Report on Form 10-Q that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Limitation on Effectiveness of Controls and Procedures
Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision making can be faulty and that breakdowns can occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies and procedures. Because of the inherent limitations in a cost-effective control system, misstatements due to error of fraud may occur and not be detected.
Risk factors
As filed, 2,573 characters, with its headings, lists and tables. Extracted from the main document; charts and exhibits are in the original on sec.gov.
Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and trading price of our securities. In addition to the other information set forth in this Quarterly Report, you should carefully consider the factors described in Part I, Item 1A. “Risk Factors” of our Annual Report . Except as set forth below, there have been no material changes from our risk factors described in “Part I, Item 1A. Risk Factors” of our Annual Report on Form 10-K.While management has plans to address these issues, there is no assurance these plans will be successful, which could materially impact our business and financial condition.
There is uncertainty regarding our ability to maintain liquidity sufficient to operate our business effectively, which raises substantial doubt about our ability to continue as a going concern.
Our unaudited condensed consolidated financial statements as of September 30, 2025 have been prepared assuming the Company will continue as a going concern for the next twelve months. Our management concluded that our recurring losses from operations, existing unrestricted cash, and cash equivalents raise substantial doubt about our ability to continue as a going concern for the next twelve months after issuance of our financial statements included in this Quarterly Report on Form 10-Q. As of September 30, 2025, we had unrestricted cash, cash equivalents and marketable securities of $69.8 million consisting of cash and investments. Subsequent to September 30, 2025, we raised additional proceeds of approximately $30 million total gross proceeds through the Company’s ATM Offering. We do not expect our existing cash and cash equivalents will be sufficient to fund our operations through the next twelve months and we will need to seek additional capital to fund our operations, working capital needs, capital expenditures and other strategic initiatives beyond that time. Although management has been successful in raising capital in the past, there can be no assurance that we will be successful or that any needed financing will be available in the future at terms acceptable to us. As such, we cannot conclude that such plans will be effectively implemented within one year after the date that the financial statements included in this Quarterly Report on Form 10-Q and there is uncertainty regarding our ability to maintain liquidity sufficient to operate our business effectively, which raises substantial doubt about our ability to continue as a going concern.
Figures reported in this filing
Standardized line items from the XBRL in this filing, for the period ended 2025-09-30. Comparative periods it repeats are left out.
| Line item | Period | Value | XBRL concept |
|---|---|---|---|
| Revenue | 3 months2025-07-01 to 2025-09-30 | $2.8m | us-gaap:Revenues |
| Revenue | 9 months2025-01-01 to 2025-09-30 | $5.0m | us-gaap:Revenues |
| Research and development | 3 months2025-07-01 to 2025-09-30 | $28.6m | us-gaap:ResearchAndDevelopmentExpense |
| Research and development | 9 months2025-01-01 to 2025-09-30 | $83.8m | us-gaap:ResearchAndDevelopmentExpense |
| Operating income | 3 months2025-07-01 to 2025-09-30 | −$34.3m | us-gaap:OperatingIncomeLoss |
| Operating income | 9 months2025-01-01 to 2025-09-30 | −$102.0m | us-gaap:OperatingIncomeLoss |
| Income tax | 3 months2025-07-01 to 2025-09-30 | $0 | us-gaap:IncomeTaxExpenseBenefit |
| Income tax | 9 months2025-01-01 to 2025-09-30 | $117.0k | us-gaap:IncomeTaxExpenseBenefit |
| Net income | 3 months2025-07-01 to 2025-09-30 | −$33.2m | us-gaap:NetIncomeLoss |
| Net income | 9 months2025-01-01 to 2025-09-30 | −$102.1m | us-gaap:NetIncomeLoss |
| Diluted EPS | 3 months2025-07-01 to 2025-09-30 | −$0.24 | us-gaap:EarningsPerShareDiluted |
| Diluted EPS | 9 months2025-01-01 to 2025-09-30 | −$0.82 | us-gaap:EarningsPerShareDiluted |
| Basic EPS | 3 months2025-07-01 to 2025-09-30 | −$0.24 | us-gaap:EarningsPerShareBasic |
| Basic EPS | 9 months2025-01-01 to 2025-09-30 | −$0.82 | us-gaap:EarningsPerShareBasic |
| Diluted shares (weighted) | 3 months2025-07-01 to 2025-09-30 | 136,811,952 shares | us-gaap:WeightedAverageNumberOfDilutedSharesOutstanding |
| Diluted shares (weighted) | 9 months2025-01-01 to 2025-09-30 | 124,723,638 shares | us-gaap:WeightedAverageNumberOfDilutedSharesOutstanding |
| Operating cash flow | 9 months2025-01-01 to 2025-09-30 | −$86.0m | us-gaap:NetCashProvidedByUsedInOperatingActivities |
| Capital expenditure | 9 months2025-01-01 to 2025-09-30 | $159.0k | us-gaap:PaymentsToAcquirePropertyPlantAndEquipment |
| Cash and equivalents | At period end2025-09-30 | $69.8m | us-gaap:CashAndCashEquivalentsAtCarryingValue |
| Current assets | At period end2025-09-30 | $88.9m | us-gaap:AssetsCurrent |
| Total assets | At period end2025-09-30 | $110.5m | us-gaap:Assets |
| Current liabilities | At period end2025-09-30 | $49.5m | us-gaap:LiabilitiesCurrent |
| Total liabilities | At period end2025-09-30 | $57.6m | us-gaap:Liabilities |
| Shareholders' equity | At period end2025-09-30 | $52.9m | us-gaap:StockholdersEquity |
Source: SEC EDGAR, the filing index for accession 0001628280-25-046809. Last ingested by Listed: Oct 29, 2026, 05:16 ET. Listed shows no prices and gives no investment advice.