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We are a clinical-stage biopharmaceutical company, and we have not yet generated significant income from operating activities. We have incurred net losses in each year since our inception in 2002, including net losses of $113.9$146.9 million and $72.7$113.9 million for the years ended December 31, 20242025 and 20232024 respectively. As of December 31, 2024,2025, we had an accumulated deficit of $286.4$1,553 million. We have devoted most of our financial resources to research and development, including our clinical and pre-clinical development activities. To date, we have financed our operations primarily through the sale of equity securities, obtaining public assistance in support of innovation, such as conditional advances from OSEO Innovation, or OSEO, reimbursements of research tax credit claims and strategic collaborations. The amount of our future net losses will depend, in part, on the pace and amount of our future expenditures and our ability to obtain funding through equity or debt financings, strategic collaborations, or additional grants or tax credits. To date, we have not generated any product revenue and we continue to advance the clinical and regulatory development of Viaskin Peanut in the United States and European Union.EU. Even if we obtain regulatory approval to market Viaskin Peanut or any other product candidate, our future revenues will depend upon the size of any markets in which our product candidates have received approval, and our ability to achieve sufficient market acceptance, reimbursement from third-party payors and adequate market share for any approved products in those markets. If the prevalence of peanut allergy is lower than we expect or declines, our revenue prospects will be smaller.

As of December 31, 2024,2025, our cash and cash equivalents were $32.5$194.2 million.million and we received from the subsequent exercise of the ABSA and BS warrants, a total gross proceed of $94 million (€81 million). 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 credits (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.

Additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates. Moreover, the terms of any financing may adversely affect the holdings or the rights of our shareholders and the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our ADSs or ordinary shares to decline. The sale of additional equity or convertible securities would dilute all of our shareholders. The incurrenceoccurrence of indebtedness would result in increased fixed payment obligations and we may be required to agree to certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. We could also be required to seek funds through arrangements with collaborative partners or otherwise at an earlier stage than otherwise would be desirable and we may be required to relinquish rights to some of our technologies or product candidates or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on our business, operating results and prospects.

In addition, the French Commercial Code imposes certain limitations on our ability to price any offering of our share capital without preferential subscription right (sans droit préférentiel de souscription), which limitation may prevent us from successfully completing any such offering. Specifically, under the French Commercial Code, unless the offering is less than 10% of issued share capital, securities cannot be sold in an offering at a price that is more than a 10% discount to the volume weighted average trading price on Euronext Paris over the last three trading days preceding the commencement of the marketing of the transaction. In addition, the combined shareholders’ meeting dated MayJune 16,11, 20242025 granted authority to our board of directors to increase our share capital up to 100% of issued share capital, if the investors in such offering fit within categories of persons meeting certain characteristics. In this casecase, securities cannot be sold in such an offering at a price that is more than a 15% discount to (i) the last closing price of the Company’s shares on the regulated market Euronext Paris prior to the date on which the issue price is set, (ii) the volume-weighted average price of the share of the Company on the regulated market of Euronext Paris over a period determined by the Board of Directors of between one to five consecutive trading days chosen from the last thirty trading days prior to the date on which the issue price is set.

The global economy, including credit and financial markets, has experienced extreme volatility and disruptions, including, among other things, severely diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, supply chain shortages, increases in inflation rates, higher interest rates and uncertainty about economic stability, due to reasons including, among other things, political changes and trends such as protectionism, economic nationalism resulting in government actions impacting international trade agreements or imposing trade restrictions such as tariffs and retaliatory counter measures. The U.S. Government, including the FDA, has also experienced recent challenges in personnel staffing related to the new administration,, which personnel shortages could adversely impact the review and responsiveness on INDs or BLAs.

Future pandemics, epidemics or other public health crises (collectively, “public health crises”) could have an impact on our ability to conduct clinical trials, and clinical site initiation, subject enrollment and subject visits (including food challenges) in any of our clinical trials may be suspended or F - 36 delayed due to prioritization of hospital resources toward responding to such public health crises. Some participants may not be able to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services. Similarly, our ability to recruit and retain subjects and principal investigators and site staff who, as healthcare providers may adversely impact our future clinical trial operations. Any future public health crises could affect, the broader economies and financial markets, triggering an economic downturn, which at points adversely affected or could adversely affect, our ability to access capital, which could negatively affect our business. In addition, the recession or resulting adverse impacts on the capital markets resulting from any future public health crises, could materially affect our business.

Our business could be materially and adversely affected by the effects of any future public health crises in regions where we or third parties on which we rely have significant manufacturing facilities, concentrations of clinical trial sites or other business operations. Any future public health crises could materially affect our operations as well as cause significant disruption in the operations and business of third-party manufacturers, CROs, other services providers, and collaborators with whom we conduct business.

It is impossible to predict all effects and the ultimate impact of any public health crises. The full extent of the impact of any future public health crises on our clinical development and other operations and financial performance depends on continuing developments that are uncertain and unpredictable, including the timing of any future vaccine development and rollouts and herd immunity, virus mutations and variants, and any new information that may emerge concerning future virus, vaccines, and containment, all of which may vary across regions. Any of these factors could have a material adverse impact on our business, financial condition, operating results, and ability to execute and capitalize on our strategies.

We have been and are required, pursuant to Section 404 of the Sarbanes-Oxley Act, to furnish a report by management on, among other things, the effectiveness of our internal control over financial reporting on an annual basis. This assessment includes disclosure of any material weaknesses identified by our management in our internal control over financial reporting. During the evaluation and testing process, if we identify one or more material weaknesses in our internal control over financial reporting, we will be unable to assert that our internal controls are effective and would be required to disclose any material weaknesses identified in Management’s Report on Internal Control over Financial Reporting. While we have established certain procedures and controlcontrols over our financial reporting processes, we cannot assure you that these efforts will prevent restatements of our financial statements in the future.

Depending on our future filer status with the SEC, our independent registered public accounting firm may also require,be required, pursuant to Section 404 of the Sarbanes-Oxley Act, to report on the effectiveness of our internal control over financial reporting. For future reporting periods, our independent registered public accounting firm may issue a report that is adverse in the event it is not satisfied with the level at which our controls are documented, designed or operating. We may not be able to remediate any future material weaknesses, or to complete our evaluation, testing and any required remediation in a timely fashion.

•the extent to which we are obligated to reimburse, or entitled to reimbursement of, clinical trial costs under our existing collaboration agreements and future collaboration agreements, if any; and F - 37

As a U.S. public company, we have incurred and will continue to incur significant legal, accounting and other expenses that we did not previously incur. We are subject to the reporting requirements of the Securities Exchange Act of 1934, or the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the Nasdaq listing requirements and other applicable securities rules and regulations. Compliance with these rules and regulations will continue to increase our legal and financial compliance costs, make some activities more difficult, time-consuming or costly and increase demand on our systems and resources, particularly as we now qualify as a domestic filer. The Exchange Act requires that, as a public company that no longer qualifies as a foreign private issuer, we file annual, quarterly and current reports with respect to our business, financial condition and resultresults of operations. Because weWe are no longer a foreign private issuer, we will also be required to file proxy statements in connection with any meetings of our shareholders. As a result of being a U.S. public company,company and the accompanying additional reporting requirements, management’s attention may be diverted from other business concerns, which could adversely affect our business and results of operations. The Sarbanes-Oxley Act requires, among other things, that we maintain effective internal controls for financial reporting and disclosure controls and procedures. In particular, we must perform system and process evaluations and testing of our internal controls over financial reporting to allow management to report on the effectiveness of our internal controls over financial reporting, as required by Section 404 of the Sarbanes-Oxley Act. Compliance with Section 404 may require that we incur substantial accounting expenses and expend significant management efforts. Our independent registered public accounting firm may also be required, pursuant to Section 404 of the Sarbanes-Oxley Act, to report on the effectiveness of our internal control over financial reporting.

As a result of disclosure of information in filings required of a U.S. public company, particularly as we are no longer a foreign private issuer, our business and financial condition will becomeare more visible than they would be if we were a privately-owned company or if our securities were listed only on Euronext Paris, which we believe may result in threatened or actual litigation, including by competitors and other third parties. If such claims are successful, our business and results of operations could be adversely affected, and even if the claims do not result in litigation or are resolved in our favor, these claims,claims and the time and resources necessary to resolve them, could divert the resources of our management and adversely affect our business and results of operations.

We are currently conducting the OLE phase of VITESSE, a Phase 3 pivotal study in children aged 4 through 7 years of age with confirmed diagnosis of peanut allergy with Type V Viaskin Peanut System, or the modified Viaskin Peanut system.age. Additionally, we are planningconducting onethe additionalCOMFORT PhaseToddlers 3supplemental safety study in response to the FDA’s request regarding the size of the controlled safety database. This safety study will be conducted in peanut allergic children 1 through 3 years of age using the Type IV Viaskin Peanut Epicutaneous System (the planned commercial Viaskin Peanut system in this age group, or cVP). Lastly, inIn connection with the Accelerated Approval pathway for Viaskin Peanut in toddlers 1 – 3-years-old1-3-years-old we will need to complete a post-marketing confirmatory study to assess the effectiveness of the intended commercial Viaskin Peanut patch that will need to be initiated at the time that the BLA is submitted. Positive results in the studies will be imperative for us to seek regulatory approval before we are permitted to commence commercialization, if ever. The confirmatory study must also be positive post-approval or the FDA may likely seek withdrawal of approval of Viaskin Peanut in the 1 - 3-year-old age group. Viaskin Milk will also require substantial additional clinical development, testing, and regulatory approval before we are permitted to commence its commercialization, if ever. Many of ourOur other product candidates are still in pre-clinical or early proof-of-concept phase development. The clinical trials of our product candidates are, and the manufacturing and marketing of our product candidates will be, subject to extensive and rigorous review and regulation by numerous government authorities in the United States and in other countries where we intend to test and, if approved, market any product candidate. Before obtaining regulatory approvals for the commercial sale of any product candidate, we must demonstrate through preclinical testing and clinical trials that, among other things, the product candidate is safe and effective for use in each target indication. This process can take many years and may include post-marketing requirements and surveillance, including the completion of pediatric clinical trials to satisfy both U.S. and EU requirements, which will require the expenditure of substantial resources. Of the large number of drugs in development in the United States, only a small percentage successfully completes the FDA regulatory approval process and are commercialized. Accordingly, even if we are able to obtain the requisite financing to continue to fund our development and clinical programs, we cannot assure you that any of our product candidates will be approved by relevant regulators or will be successfully developed or commercialized.

In addition, in some jurisdictions such as the EU, initiating Phase 3 clinical trials, including clinical trials in the pediatric population, is subject to a requirement to obtain approval or a waiver from the competent authorities of the EU Member StatesStates. and/For trials involving pediatric populations, sponsors must also have agreed on a Pediatric Investigation Plan (“PIP”) or thea EMA.granted waiver/deferral. If we do not obtain such approval our ability to conduct clinical trials and obtain marketing authorizations may be severely impaired and our business may be adversely impacted.

•the clinical research organizations, or CROs,CROs that we retain to conduct our clinical trials may take actions outside of our control that materially adversely impact our clinical trials;

•the FDA or the applicable foreign regulatory authority may require development or implementation of a Risk Evaluation and Mitigation Strategy (or REMS), or comparable foreign requirements, as a condition of approval or post-approval;

The results of pre-clinical studies do not necessarily predict clinical success, and larger and later-stage clinical trials may not produce the same results as earlier-stage clinical trials. As a result, we may not observe a similarly favorable safety and efficacy profile as our prior clinical trials. For example, in August 2020, we received a Complete Response Letter, or CRL,CRL in which the FDA indicated it could not approve the Viaskin Peanut BLA in its then-current form. The FDA identified concerns regarding the impact of system adhesion on efficacy and indicated the need for modifications, and new human factors studies. The FDA also indicated that supplementary clinical data would need to be generated to support applications for both the Type IV Viaskin Peanut System , or cVP, and the Type V Viaskin Peanut System (the modified Viaskin Peanut System), or mVP, and requested additional Chemistry, Manufacturing and Controls, or CMC,CMC data. Further, in September 2022, we announced that FDA had imposed a partial clinical hold on the VITESSE trial, which was lifted in December 2022 after we made additional revisions to the protocol in order to address FDA concerns. In addition, we cannot assure you that in the course of potential widespread use in future, some drawbacks would not appear in maintaining production quality, protein stability or allergenic strength. Frequently, product candidates developed by pharmaceutical, biopharmaceutical and biotechnology companies have shown positive results in early pre-clinical studies or clinical trials, but have subsequently suffered significant setbacks or failed in later clinical trials. In addition, clinical trials of potential products sometimes reveal that it is not possible or practical to continue development efforts for these product candidates.

In many of our clinical trials, we utilize an oral food challenge procedure intentionally designed to trigger an allergic reaction, which could be severe or life-threatening.

In accordance with our food allergy clinical trial protocols, we utilize a double-blind, placebo-controlled food challenge procedure at various points in our clinical trials. This consists of giving the offending food protein to subjects to assess the sensitivity of their food allergy to determine eligibility to participate and to evaluate the efficacy of our product candidates versus placebo. The food challenge protocol is meant to induce objective symptoms of an allergic reaction. These oral food challenge procedures can potentially trigger anaphylaxis or potentially life-threatening systemic allergic reactions. Even though these procedures are well-controlled, standardized and performed in highly specialized centers with intensive care units, there are inherent risks in conducting a trial of this nature. An uncontrolled allergic reaction could potentially lead to serious or even fatal reactions. Any such serious clinical event could potentially adversely affect our clinical development timelines, including a complete clinical hold on our food allergy clinical trials. We may also become liable to subjects who participate in our clinical trials and experience any such serious or fatal reactions. Any of the foregoing could have a material adverse effect on our business, prospects, stock price or financial condition.

•reaching agreement on acceptable terms with prospective CROs,CROs and clinical trial sites;

•obtaining timely responses from and permission to proceed from the FDA under an investigational new drug, or IND,IND application, or foreign equivalent approval from regulatory authorities outside the United States;

•obtaining institutional review board, or IRB,IRB approval or positive Ethics Committee opinions as part of the single decision on the authorization of a clinical trial issued by EU Member States including input from the national competent authority and Ethics Committee, to conduct a clinical trial at a prospective clinical trial site;

We may, in the future, conduct clinical trials for, and seek regulatory approval to market, product candidates in countries other than the United States. Depending on the results of clinical trials and the process for obtaining regulatory approvals in other countries, we may decide to first seek regulatory approvals of a product candidate in countries other than the United States, or we may simultaneously seek regulatory approvals in the United States and other countries. If we or our collaborators seek marketing approvals for a product candidate outside the United States, we will be subject to the regulatory requirements of health authorities in each country in which we seek approvals. With respect to marketing authorizations in the European Union, we will be required to submit an MAA to the EMA or the national competent authorities of EU Member States, which conductsconduct a validation and scientific review process in evaluating a product for safety and efficacy. The regulatory approval procedures vary among countries and may involve additional testing, and the time required to obtain approvals may differ from that required to obtain FDA approval.

The FDA or comparable foreign regulatory authorities may also impose requirements for costly post-marketing studies or clinical trials and surveillance to monitor the safety or efficacy of a product, such as long-term observational studies on natural exposure. The FDA and other agencies, including, without limitation, the U.S. Department of Justice, and comparable foreign regulatory authorities closely regulate and monitor the post-approval marketing and promotion of products to ensure that they are manufactured, marketed, and distributed only for the approved indications and in accordance with the provisions of the approved labeling. The FDA and comparable foreign regulatory authorities impose stringent restrictions on manufacturers’ communications regarding off-label use and if we, or our collaborators, market any of our product candidates for which we, or they, receive regulatory approval for treatment other than their approved indications, we, or they, may be subject to warnings or enforcement action for off-label marketing. Violation of the Federal Food, Drug, and Cosmetic Act, or FDCA,FDCA and other statutes, including the False Claims Act, relating to the promotion and advertising of prescription drugs may lead to investigations or allegations of violations of federal and state health care fraud and abuse laws and state consumer protection laws.

We are dependent on third parties for the supply of various materials, chemical or biological products that are necessary to produce Viaskin patches for our clinical trials, and will need to depend on third parties to produce patches for our commercial supply, if Viaskin Peanut is approved. The supply of these materials could be reduced or interrupted at any time, including, without limitation, as a result of impacts due to pandemics, epidemics or other global health crises, natural disasters, new laws or regulations applicable to us or our suppliers, or other unfavorable global economic conditions, including as a result of the ongoing conflict between Russia-Ukraine, Israel-Hamas and other global political or military conflicts. In such case, we may not be able to find other suppliers of acceptable materials in appropriate quantities at an acceptable cost. If key suppliers or manufacturers are lost or the supply of materials is diminished or discontinued, we may not be able to continue to develop, manufacture and market our product candidates or products, if any, in a timely and competitive manner. In addition, these materials are subject to stringent manufacturing processes and rigorous testing. Delays in the completion and validation of facilities and manufacturing processes of these materials could adversely affect our ability to complete trials and commercialize our products, if any, in a cost-effective and timely manner. To prevent such situations, we intend to diversify our supply sources by identifying a second source of supply for critical raw materials and materials, such as natural protein. If we encounter difficulties in the supply of these materials, chemicals or biological products, if we were not able to maintain our supply agreements or establish new agreements to develop and manufacture our products in the future, our business, prospects, financial condition, results and development could be significantly affected.

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 active pharmaceutical ingredients, or API,API used in our Viaskin product candidates, including Viaskin Peanut, such as peanut protein extract and unmodified allergen milk extract. In February 2020, Sanofi announced that it plansplanned 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. Further, Sanofi’s strategic alliance partner, Regeneron, entered into a clinical collaboration with Aimmune Therapeutics, to evaluate treatment with Palforzia in combination with Dupilumab in peanut allergic patients. Regeneron commenced a Phase 2 clinical trial in October 2018 under this collaboration. This potential competitive dynamic may make Sanofi less inclined to continue or renew their manufacturing arrangement with us on commercially reasonable terms or at all and, notwithstandingNotwithstanding contractual protections, Sanofi may be able to utilize knowledge gained through their relationship with us in furtherance of their development of competitive therapies.

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 current good manufacturing practices, or cGMPs,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 Quality System Regulation, or QSR,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.

The Biologics Price Competition and Innovation Act, or BPCIA,BPCIA established an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product. “Biosimilarity” means that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components and there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency of the product. To meet the higher standard of “interchangeability,” an applicant must provide sufficient information to show biosimilarity and demonstrate that the biological product can be expected to produce the same clinical result as the reference product in any given patient and, if the biological product is administrated more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between the use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch.

In the EU, following grant of a related marketing authorization, innovative medicinal products generally benefit from eight years of data exclusivity and 10 years of market exclusivity. Data exclusivity, if granted, prevents regulatory authorities in the European UnionEU from referencing the innovator’s data to assess a generic application or biosimilar application for eight years from the date of authorization of the innovative product. After this period, an application for marketing authorization for a generic or biosimilar product may be submitted, and the innovator’s data may be referenced. The market exclusivity period prevents a successful generic or biosimilar applicant from commercializing its product in the European Union until 10 years have elapsed from the initial marketing authorization of the reference product in the European Union.EU. The overall ten-year period may, occasionally, be extended for a further year to a maximum of 11 years if, during the first eight years following authorization of the reference product, the marketing authorization holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies. There is, however, no guarantee that a product will be considered by the European Union’sEU’s regulatory authorities to be a new chemical/biological entity, and products may not qualify for data exclusivity.

In the European Union,EU, there is also a special regime for biosimilars, or biological medicinal products that are similar to a reference medicinal product but that do not meet the definition of a generic medicinal product. For such products, the results of appropriate preclinical or clinical trials must be provided in support of a related application for Marketing Authorization.MA. Guidelines from the EMA detail the type and quantity of supplementary data to be provided for different types of biological product.

In the case of food allergies, we are aware of several food allergy academic studies and pharmaceutical developmental efforts connected with such studies that are currently being conducted in major medical centers and hospitals worldwide. These studies are evaluating forms of allergen desensitization treatments such as oralOIT, (OIT),SLIT, sublingualSCIT, (SLIT),OMIT, subcutaneous (SCIT), or oral mucosal (OMIT), cutaneous (CIT), and intranasal (INT) immunotherapy, or products using synthetic allergens, denatured allergens, small molecule inhibitors, or combinations of medicines or methods, or medicines using traditional methods such as Chinese herbs.

There is one treatment that is specific for peanut allergy in children 1 to 17 years of age, a proprietary form of OIT which was approved by the FDA and the European Commission: Palforzia, formulation of peanut flour developed by Aimmune Therapeutics, Inc., or Aimmune. Nestlé S.A. acquired Aimmune in October 2020, and divested the Palforzia business to Stallergenes Greer in September 2023. In December 2025, Stallergenes Greer announced that it will discontinue commercialization of Palforzia on July 31, 2026.

Sales of our products, when and if approved for marketing, will depend, in part, on the extent to which our products will be covered by third-party payors, such as federal, state, and foreign government health care programs, commercial insurance and managed healthcare organizations. There may be significant delays in obtaining coverage and reimbursement for newly approved products, and coverage may be more limited than the purposes for which the product is approved by the FDA or comparable foreign regulatory authorities. Moreover, eligibility for coverage and reimbursement does not imply that a product will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sales and distribution. Third-party payors are increasingly reducing reimbursements for medical products, drugs and services. Further, coverage policies and third-party reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more products for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future. In addition, the U.S. government, state legislatures and foreign governments have continued implementing cost containment programs, including price controls, restrictions on coverage and reimbursement and requirements for substitution of generic products. For example, HHS imposes rebates on many Medicare Part B and Medicare Part D products to penalize price increases that outpace inflation on an annual basis. HHS has also been empowered to negotiate the price of certain single-source biologics that have been on the market for at least eleven (11) years covered under Medicare as part of the Medicare Drug Price Negotiation Program. Each year up to twenty (20) products will be selected by HHS for the Medicare Drug Price Negotiation Program. Products subject to the Medicare Drug Price Negotiation Program are expected to experience a significant reduction in reimbursement from the Medicare program on a per unit basis. Adoption of price controls and cost containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit our net revenue and results. Limited third-party reimbursement for our product candidates or a decision by a third-party payor not to cover our product candidates could reduce physician usage of our products once approved and have a material adverse effect on our sales, results of operations and financial condition.

Many EU Member States periodically review their reimbursement procedures for medicinal products, which could have an adverse impact on reimbursement status. Moreover, in order to obtain reimbursement for our products in some European countries, including some EU Member States, we may be required to compile additional data comparing the cost-effectiveness of our products to other available therapies. This Health Technology Assessment,Assessment or HTA,(“HTA”) of medicinal products is becoming an increasingly common part of the pricing and reimbursement procedures in some EU Member States, including those representing the larger markets. The HTA process is the procedure to assess therapeutic, economic and societal impact of a given medicinal product in the national healthcare systems of the individual country. The outcome of an HTA will often influence the pricing and reimbursement status granted to these medicinal products by the competent authorities of individual EU Member States. The extent to which pricing and reimbursement decisions are influenced by the HTA of the specific medicinal product currently varies between EU Member States. InOn DecemberJanuary 2021,12, 2025, Regulation No. 2021/2282 on Health Technology Assessment, amending Directive 2011/24/EU, was adopted in the EU. This Regulation, whichEU entered into force on January 12, 2025 and hasthrough a phased implementation,implementation. It is intended to boost cooperation among EU Member States in assessing health technologies, including new medicinal products, and providingestablishes the basis for cooperation at EU levelframework for joint clinical assessmentsassessments, injoint thesescientific areas.consultations, and the early identification of emerging health technologies. The Regulation permits EU Member States to use common HTA tools, methodologies, and procedures across the EU,EU workingand togetherrequires inthem fourto mainrely areas,on includingEU-level joint clinical assessment ofreports for the innovativeclinical healthcomponents technologiesof withtheir the most potential impact for patients, joint scientific consultations whereby developers can seek advice fromnational HTA authorities, identification of emerging health technologies to identify promising technologies early, and continuing voluntary cooperation in other areas.evaluations. Individual EU Member States continue to be responsible for assessing non-clinical (e.g., economic, social, ethical) aspects of health technologies, and making decisions on pricing and reimbursement. If we are unable to maintain favorable pricing and reimbursement status in EU Member States for product candidates that we may successfully develop and for which we may obtain regulatory approval, any anticipated revenue from and growth prospects for those products in the EU could be negatively affected.

We are a clinical-stagelate-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.

Financial OverviewFinancing

Subsequent to December 31, 2024, theThe 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 20252025, for an amount of €38 million,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 netgross 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.2025.

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.

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.

InDuring the firstsecond quarter of 2026, the Company startedcontinued to executeadvance itsthe plankey forelements supporting the potential U.S. commercialization of theVIASKIN® ViaskinPeanut, Peanutincluding patchregulatory for children aged 4 to 7, following regulatory,readiness, clinical anddevelopment, financial developments in 2025 that will support a BLA filingmanufacturing and havesupply-chain increasedpreparedness, cashcommercial launch planning and cashinstitutional equivalents.investor engagement.

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.

Comparison of the Three Months Ended MarchJune 31,30, 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 MarchJune 31,30, 2026 and 2025.

The following table summarizes our operating income during the three months ended MarchJune 31,30, 2026 and 2025:

This caption consists of Research Tax Credit (crédit d’impôt recherche, or CIR) that is granted to companies by the French tax authorities in order to encourage them to conduct technical and scientific researches. The Company accrued $0.9 million as of March 31, 2026. This level in tax credit incomedecreased by $0.7 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025. The accrual reflectsis onconsistent a full year basiswith the expectedprior quarter and reflects the lower level of eligible experimentalresearch activities, as the Company’s focus continues to shift from clinical development toward commercial readiness activities.

The following table summarizes our research and development expenses incurred during the three months ended MarchJune 31,30, 2026 and 2025:

External clinical-related expenses increaseddecreased by $10.0$(3.2) million for the three months ended Marchended 31,June 202630, 2026, compared to the three months ended MarchJune 31,30, 20252025. mainlyThe duedecrease towas higher clinical trial activityprimarily driven by the initiationcompletion of patientthe recruitmentEPOPEX forstudy, while expenditures associated with the VITESSE and COMFORT Toddlers study,programs andremained toglobally the acceleration of BLA readiness activities to prepare BLA submission.consistent.

Depreciation, amortization and otherEmployee-related costs decreasedincreased by $0.7$3.0 million for the three months ended Marchended 31,June 30, 2026, compared to the three months ended MarchJune 31,30, 20252025. primarilyThis dueincrease was mainly driven by hirings to lowersupport depreciationdevelopment, medical affairs, regulatory and amortization.quality Other costs reduced as well in the absence of certain prior-year charges.capabilities.

The following table summarizes our sales and marketing expenses incurred during the three months ended Marchended 31,June 30, 2026 and 2025:

Sales and marketing expenses have increased by $4.6$5.1 million during the three months ended MarchJune 31,30, 2026, compared to the three months ended MarchJune 31,30, 20252025, primarily reflecting the continued execution of the Company’s go‑to‑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 strategy.access and launch-support capabilities in preparation for a potential launch of VIASKIN® Peanut, if approved.

The following table summarizes our general and administrative expenses incurred during the three months ended MarchJune 31,30, 2026 and 2025:

General and Administrative expenses increased by $4.9$6.1 million for the three months ended MarchJune 31,30, 2026, compared to the three months ended MarchJune 31,30, 2025.2025, primarily reflecting continued scaling of the Company’s corporate infrastructure to support BLA readiness and commercial launch preparedness.

Our financial income was $0.5$0.4 million for the three months ended MarchJune 31,30, 2026, compared to a financial expense of $0.5$0.6 million for the three months ended MarchJune 31,30, 2025.2025, Thisprimarily itemreflecting mainly includes thehigher interest income ongenerated ourfrom shortthe terminvestment investments.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.

Our income tax expense was $0.2 million for the three months ended MarchJune 31,30, 2026 comparedand towas nil$0.1 million for the three months ended MarchJune 31,30, 2025. The income tax expense for the current period relates to the Company’s U.S. subsidiary, which generated taxable income pursuant to the Company’s intercompany transfer pricing arrangements.

Net loss was $47.6$50.4 million for the three months ended MarchJune 31,30, 2026, compared to $27.1$41.9 million for the three months ended MarchJune 31,30, 2025. Net loss per share (based on the weighted average number of shares outstanding over the period) decreased fromwas $(0.260.12) toand $(0.110.31) for the three months ended MarchJune 31,30, 20252026 and March 31, 2026,2025, respectively. This improvement reflects a significantly strengthened equity base following recent financings.