−Removed: Risk Factors.
Investing in our securities involves a high degree of risk.
2 unchanged sentences
Additional risks that are currently unknown to us or that we currently believe to be immaterial may also impair our business.
−Removed: circumstances, the market price of our securities could decline, and holders of our securities may lose all or part of their investment.
+Added: In these circumstances, the market price of our securities could decline, and holders of our securities may lose all or part of their investment.
We cannot provide assurance that any of the events discussed below will not occur.
5 unchanged sentences
We have devoted most of our financial resources to research and development, including our clinical and pre-clinical development activities.
−Removed: 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.
+Added: To date, we have financed our operations primarily through the sale of equity securities, obtaining public assistance in support of innovation, 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.
−Removed: 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.
+Added: 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 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.
+Added: If the prevalence of peanut allergy is lower than we expect or declines, our revenue prospects will be smaller.
Our near-term prospects, including our ability to finance our company and generate revenue, will depend heavily on the successful development, regulatory approval and commercialization of Viaskin Peanut.
20 unchanged sentences
In any particular period or periods, our operating results could be below the expectations of securities analysts or investors, which could cause the price of our ADSs or ordinary shares to decline.
−Removed: The Company has incurred operating losses and negative cash flows from operations since inception.
−Removed: Subsequent to December 31, 2024, the Company raised additional proceeds in a private placement financing (the “2025 PIPE”) consisting of i) a share capital increase without preferential subscription rights reserved to categories of persons satisfying determined characteristics pursuant to the 24th resolution of the general meeting of shareholders of May 16, 2024 (the "2024 General Meeting") completed on April 7, 2025 for an amount of €38 million, consisting of the issuance of (i) 34,090,004 new shares at a par value of €0.10 (the "New Shares") each with warrants of the Company attached (the "ABSA Warrants", and together with the New Shares, the "ABSA") at a subscription price of €1.1136 per ABSA and (ii) up to 59,657,507 additional new shares, if all the ABSA Warrants attached to the New Shares are exercised (the "ABSA Warrant Shares");
−Removed: and ii) the issue through an offering reserved to categories of persons satisfying determined characteristics of 71,005,656 units (the “PFW-BS-PFW”) completed on April 7, 2025 for an amount of €79 million at a subscription price of €1.1136 per PFW-BS-PFW (of which €1.1036 will have been prefunded on the issue date), each PFW-BS-PFW consisting of one pre-funded warrant to subscribe for one share of the Company (the "First Pre-Funded Warrants") and one warrant (the "BS Warrants") to subscribe to one second pre-funded warrants (the "Second Pre-Funded Warrants"), each of which entitles the holder to subscribe for 1.75 shares of the Company (the "Second PFW Shares"), allowing to issue up to 71,005,656 additional new shares if all the First Pre-Funded Warrants are exercised (the "First PFW Shares") and up to 124,259,898 additional new shares if all the Second Pre-Funded Warrants are exercised (the "Second PFW Shares", together with the ABSA Warrant Shares and the First Pre-Funded Warrant Shares, the "Warrant Shares", and together with the New Shares, the
−Removed: "Offered Shares").
−Removed: The Company received initial net proceeds of $125.5 million (€116.3 million) on April 7, 2025, and based on our current operations, plans and assumptions, we estimate that our balance of cash and cash equivalents will be sufficient to fund our operations into June 2026.
−Removed: 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.
We will require substantial additional funding, which may not be available on acceptable terms, or at all.
4 unchanged sentences
In addition, our expenses could increase beyond expectations if the FDA requires us to perform nonclinical studies, clinical trials or post-approval clinical trials for our approved products, if any, in addition to those that we currently anticipate.
−Removed: As of December 31, 2024, our cash and cash equivalents were $32.5 million.
+Added: As of December 31, 2025, our cash and cash equivalents were $194.2 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.
−Removed: Based on our current operations, as well as our plans and assumptions, we expect that our balance of cash and cash equivalents of $32.5 million as of December 31, 2024 will be sufficient to fund our operations into April 2025.
−Removed: Subsequent to December 31, 2024, the Company raised additional proceeds in the 2025 PIPE of initial net proceeds of $125.5 million (€116.3 million) received 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.
−Removed: 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.
We may need to raise additional capital as we prepare for the launch of Viaskin Peanut, if approved, and continue other research and development efforts.
6 unchanged sentences
The sale of additional equity or convertible securities would dilute all of our shareholders.
−Removed: The incurrence 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.
+Added: The occurrence 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.
5 unchanged sentences
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.
−Removed: In addition, the combined shareholders’ meeting dated May 16, 2024 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.
−Removed: In this case 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
−Removed: 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.
+Added: In addition, the combined shareholders’ meeting dated June 11, 2025 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.
+Added: In this case, 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.
Our business could be adversely affected by economic downturns, inflation, increases in interest rates, natural disasters, public health crises, political crises, geopolitical events, or other macroeconomic conditions, which have in the past and may in the future negatively impact our business and financial performance.
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.
−Removed: 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.
−Removed: 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 delayed due to prioritization of hospital resources toward responding to such public health crises.
+Added: Government, including the FDA, has also experienced recent challenges in personnel staffing , which personnel shortages could adversely impact the review and responsiveness on INDs or BLAs.
+Added: 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
+Added: 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.
6 unchanged sentences
Increased inflation rates can adversely affect us by increasing our costs, including labor and employee benefit costs.
−Removed: 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.
+Added: Our business could be materially and adversely affected by the effects of 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.
−Removed: It is impossible to predict all effects and the ultimate impact of any public health crises.
+Added: It is impossible to predict all effects and the ultimate impact of 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.
−Removed: On February 24, 2022, Russian forces launched significant military action against Ukraine, and sustained conflict and disruption in the region is possible.
−Removed: The impact to Ukraine as well as actions taken by other countries, including new and stricter sanctions imposed by Canada, the United Kingdom, the European Union, the United States and other countries and companies and organizations against officials, individuals, regions, and industries in Russia and Ukraine, and actions taken by Russia in response to such sanctions, and responses of countries and political bodies to such sanctions, tensions, and military actions and the potential for more widespread conflict, have resulted in supply chain disruptions, and resulting increases in inflation, financial market volatility and capital markets disruption, potentially increasing in magnitude, and such effects on the global economy and financial markets could affect our business, operations, operating results and financial condition as well as the price of our common stock and our ability to raise additional capital when needed on acceptable terms.
−Removed: Separately, in early October 2023, Hamas, a militant group in control of Gaza, and Israel began an armed conflict in Israel, the Gaza Strip, and surrounding areas, which threatens to spread to other Middle Eastern countries, including Lebanon, Syria, and Iran.
−Removed: The Hamas-Israel military conflict is ongoing, and its length and outcome are highly unpredictable.
−Removed: Any or all of the effects of these conflicts could disrupt our and our collaborators’ supply chains and adversely affect our and our collaborators’ ability to conduct ongoing and future clinical trials of our product candidates.
+Added: Conflicts could disrupt our and our collaborators’ supply chains and adversely affect our and our collaborators’ ability to conduct ongoing and future clinical trials of our product candidates.
The extent and duration of the military action, sanctions and resulting economic, market and other disruptions are impossible to predict, but could be substantial.
5 unchanged sentences
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.
−Removed: While we have established certain procedures and control over our financial reporting processes, we cannot assure you that these efforts will prevent restatements of our financial statements in the future.
−Removed: Depending on our future filer status with the SEC, our independent registered public accounting firm may also require, pursuant to Section 404 of the Sarbanes-Oxley Act, to report on the effectiveness of our internal control over financial reporting.
+Added: While we have established certain procedures and controls over our financial reporting processes, we cannot assure you that these efforts will prevent restatements of our financial statements in the future.
+Added: Depending on our future filer status with the SEC, 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.
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.
26 unchanged sentences
public company, we have incurred and will continue to incur significant legal, accounting and other expenses that we did not previously incur.
−Removed: 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.
−Removed: 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.
−Removed: 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 result of operations.
−Removed: Because we are no longer a foreign private issuer, we will also be required to file proxy statements in connection with any meetings of our shareholders.
+Added: We are subject to the reporting requirements of 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.
+Added: 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 qualify as a domestic filer.
+Added: The Exchange Act requires that, we file annual, quarterly and current reports with respect to our business, financial condition and results of operations.
+Added: We are required to file proxy statements in connection with any meetings of our shareholders.
As a result of being a U.S.
−Removed: public company, management’s attention may be diverted from other business concerns, which could adversely affect our business and results of operations.
+Added: public 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.
4 unchanged sentences
In the event we identify significant deficiencies or material weaknesses in our internal controls that we cannot remediate in a timely manner, or if our independent registered public accounting firm is unable to express an opinion that our internal controls over financial reporting are effective, the market price of our ordinary shares and ADSs could decline if investors and others lose confidence in the reliability of our financial statements, we could be subject to sanctions or investigations by the SEC or other applicable regulatory authorities and our business could be harmed.
−Removed: public company that is subject to these rules and regulations, we may find it is more expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage.
−Removed: These factors could also make it more difficult for us to attract and retain qualified members of our board of directors, particularly to serve on our audit committee and compensation committee, and qualified executive officers.
As a result of disclosure of information in filings required of a U.S.
−Removed: public company, particularly as we are no longer a foreign private issuer, our business and financial condition will become 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.
+Added: public company, our business and financial condition are 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 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.
7 unchanged sentences
We may not be successful in developing and commercializing Viaskin Peanut and our other product candidates, including, without limitation, Viaskin Milk, and our commercial opportunities may be limited.
−Removed: We are currently conducting 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.
−Removed: Additionally, we are planning one additional Phase 3 safety study in response to the FDA’s request regarding the size of the controlled safety database.
−Removed: 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).
−Removed: Lastly, in connection with the Accelerated Approval pathway for Viaskin Peanut in toddlers 1 – 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.
+Added: We are currently conducting the OLE phase of VITESSE, a Phase 3 pivotal study in children aged 4 through 7 years of age.
+Added: Additionally, we are conducting the COMFORT Toddlers supplemental safety study 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).
+Added: In connection with the Accelerated Approval pathway for Viaskin Peanut in toddlers 1-3-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.
−Removed: 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.
+Added: The confirmatory study must also be positive post-approval or the FDA may 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.
−Removed: Many of our other product candidates are still in pre-clinical or early proof-of-concept phase development.
+Added: Our 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.
4 unchanged sentences
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.
−Removed: 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 States and/or the EMA.
+Added: 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 from the competent authorities of the EU Member States.
+Added: For trials involving pediatric populations, sponsors must also have agreed on a Pediatric Investigation Plan (“PIP”) or a 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.
6 unchanged sentences
• the FDA or the applicable foreign regulatory authority may not approve the formulation, labeling or specifications of a product candidate;
−Removed: • the clinical research organizations, or CROs, that we retain to conduct our clinical trials may take actions outside of our control that materially adversely impact our clinical trials;
+Added: • the 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 find the data from pre-clinical studies and clinical trials from a product candidate insufficient to demonstrate that the clinical or other benefits of such product candidate outweighs its respective safety risks;
2 unchanged sentences
• an advisory committee, or similar body, may recommend against approval of our application or may recommend that the FDA or the applicable foreign regulatory authority require, as a condition of approval, additional pre-clinical studies or clinical trials, limitations on approved labeling or distribution and use restrictions;
−Removed: • 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;
+Added: • the FDA or the applicable foreign regulatory authority may require development or implementation of a REMS or comparable foreign requirements, as a condition of approval or post-approval;
• the FDA or the applicable foreign regulatory authority may restrict the use of our products to a narrow population;
21 unchanged sentences
As a result, we may not observe a similarly favorable safety and efficacy profile as our prior clinical trials.
−Removed: For example, in August 2020, we received a Complete Response Letter, or CRL, in which the FDA indicated it could not approve the Viaskin Peanut BLA in its then-current form.
+Added: For example, in August 2020, we received a 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.
−Removed: 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, data.
+Added: The FDA also indicated that supplementary clinical data would need to be generated to support applications for the Type IV Viaskin Peanut System , or cVP, and requested additional 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.
6 unchanged sentences
If our clinical trials are substantially delayed or fail to prove the safety and effectiveness of our product candidates in development, we may not receive regulatory approval of any of these product candidates and our business and financial condition will be materially harmed.
−Removed: In many of clinical trials, we utilize an oral food challenge procedure intentionally designed to trigger an allergic reaction, which could be severe or life-threatening.
+Added: 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.
15 unchanged sentences
• manufacturing sufficient quantities of a product candidate;
−Removed: • obtaining timely responses from and permission to proceed from the FDA under an investigational new drug, or IND, application, or foreign equivalent approval from regulatory authorities outside the United States;
−Removed: • obtaining institutional review board, or 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;
+Added: • obtaining timely responses from and permission to proceed from the FDA under an IND application, or foreign equivalent approval from regulatory authorities outside the United States;
+Added: • obtaining 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;
• determining dosing and clinical design and making related adjustments;
62 unchanged sentences
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.
−Removed: With respect to marketing authorizations in the European Union, we will be required to submit an MAA to the EMA which conducts a validation and scientific review process in evaluating a product for safety and efficacy.
+Added: 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 conduct 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.
15 unchanged sentences
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.
−Removed: Violation of the Federal Food, Drug, and Cosmetic Act, or 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.
+Added: Violation of the 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.
Failure to comply with EU and EU Member State laws that apply to the conduct of clinical trials, manufacturing approval, marketing authorization of medicinal products and marketing of such products, both before and after grant of the marketing authorization, or with other applicable regulatory requirements may result in administrative, civil or criminal penalties.
27 unchanged sentences
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.
−Removed: Currently, we have only one manufacturer, Sanofi S.A., or Sanofi, of the active pharmaceutical ingredients, or API, used in our Viaskin product candidates, including Viaskin Peanut, such as peanut protein extract and unmodified allergen milk extract.
−Removed: In February 2020, Sanofi announced that it plans to create a new company dedicated to the production and marketing to third parties of API.
+Added: Currently, we have only one manufacturer, Sanofi S.A., or Sanofi, of the API used in our Viaskin product candidates, including Viaskin Peanut, such as peanut protein extract and unmodified allergen milk extract.
+Added: In February 2020, Sanofi announced that it planned to create a new company dedicated to the production and marketing to third parties of API.
Subsequently, Sanofi consolidated its API commercial and development activities conducted in six of its European API production sites.
1 unchanged sentence
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.
−Removed: 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.
−Removed: Regeneron commenced a Phase 2 clinical trial in October 2018 under this collaboration.
−Removed: 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, notwithstanding contractual protections, Sanofi may be able to utilize knowledge gained through their relationship with us in furtherance of their development of competitive therapies.
+Added: Notwithstanding contractual protections, Sanofi may be able to utilize knowledge gained through their relationship with us in furtherance of their development of competitive therapies.
+Added: In December 2025, Stallergenes Greer announced that it intends to discontinue the commercialization of Palforzia, on July 31, 2026, for business reasons.
We also expect to rely on Sanofi and on FAREVA for the manufacturing of the patch and on other third-party manufacturers for the manufacturing of commercial supply of Viaskin Peanut, if approved, and any other product for which we obtain regulatory approval.
7 unchanged sentences
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.
−Removed: Manufacturers of products with which we contract are required to operate in accordance with FDA-mandated current good manufacturing practices, or cGMPs, or comparable GMP requirements in foreign countries.
+Added: Manufacturers of products with which we contract are required to operate in accordance with FDA-mandated cGMPs or comparable GMP requirements in foreign countries.
A failure of any of our contract manufacturers to establish and follow cGMPs and to document their adherence to such practices may lead to significant delays in the launch or availability of products based on our product candidates into the market.
−Removed: 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, or comparable quality management systems in foreign countries, applicable to medical devices, such as design controls, purchasing controls, and corrective and preventive action.
+Added: Moreover, the constituent parts of a combination product retain their regulatory status (as a biologic or medical device, for example) and, as such, we or our contract manufacturers may be subject to additional requirements in the QSR or comparable quality management systems in foreign countries, applicable to medical devices, such as design controls, purchasing controls, and corrective and preventive action.
We, our contract manufacturers, any future collaborators and their contract manufacturers could be subject to periodic unannounced inspections by the FDA or other comparable foreign regulatory authorities, to monitor and ensure compliance with cGMP.
56 unchanged sentences
Our product candidates are regulated as biological products, or biologics, which may subject them to competition sooner than anticipated.
−Removed: The Biologics Price Competition and Innovation Act, or BPCIA, established an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product.
+Added: The 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.
6 unchanged sentences
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.
−Removed: Data exclusivity, if granted, prevents regulatory authorities in the European Union 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.
+Added: Data exclusivity, if granted, prevents regulatory authorities in the EU 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.
−Removed: 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.
+Added: 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 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.
−Removed: There is, however, no guarantee that a product will be considered by the European Union’s regulatory authorities to be a new chemical/biological entity, and products may not qualify for data exclusivity.
−Removed: In the European Union, 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.
−Removed: For such products, the results of appropriate preclinical or clinical trials must be provided in support of a related application for Marketing Authorization.
+Added: There is, however, no guarantee that a product will be considered by the EU’s regulatory authorities to be a new chemical/biological entity, and products may not qualify for data exclusivity.
+Added: In the 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.
+Added: For such products, the results of appropriate preclinical or clinical trials must be provided in support of a related application for MA.
Guidelines from the EMA detail the type and quantity of supplementary data to be provided for different types of biological product.
20 unchanged sentences
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.
−Removed: These studies are evaluating forms of allergen desensitization treatments such as oral (OIT), sublingual (SLIT), 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.
+Added: These studies are evaluating forms of allergen desensitization treatments such as OIT, SLIT, SCIT, OMIT, CIT and 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.
Studies combining other methods of allergen immunotherapy, such as OIT, with monoclonal antibodies (anti-IgE and anti-IL-4Rα) as adjunct therapy are being conducted currently.
3 unchanged sentences
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:
−Removed: Palforzia, formulation of peanut flour developed by Aimmune Therapeutics, Inc., or Aimmune.
+Added: Palforzia, formulation of peanut flour developed by Aimmune.
acquired Aimmune in October 2020, and divested the Palforzia business to Stallergenes Greer in September 2023.
+Added: In December 2025, Stallergenes Greer announced that it will discontinue commercialization of Palforzia on July 31, 2026.
Government restrictions on pricing and reimbursement, as well as other healthcare payor cost-containment initiatives, may negatively impact our ability to generate revenues if we obtain regulatory approval to market a product.
12 unchanged sentences
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.
+Added: 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.
+Added: 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.
+Added: Each year up to twenty (20) products will be selected by HHS for the Medicare Drug Price Negotiation Program.
+Added: 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.
−Removed: Various provisions of the Patient Protection and Affordable Care Act as amended by the Health Care and Education Reconciliation Act, or collectively, the ACA, were designed to impact the provision of, or payment for, health care in the United States, including expanded Medicaid eligibility, subsidized insurance premiums, provided incentives for businesses to provide health care benefits, prohibited denials of coverage due to pre-existing conditions, established health insurance exchanges, and provided additional support for medical research.
−Removed: With regard to biopharmaceutical products, among other things, the ACA expanded and increased industry rebates for drugs covered under Medicaid programs and made changes to the coverage requirements under the Medicare prescription drug benefit.
−Removed: However, there have been amendments to and executive, judicial and Congressional challenges to certain aspects of the ACA.
−Removed: For example, on August 16, 2022, the Inflation Reduction Act of 2022, or IRA, was signed into law, which, among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025.
−Removed: The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and creating a new manufacturer discount program.
−Removed: It is possible that the ACA will be subject to judicial or Congressional challenges in the future.
−Removed: It is unclear how such challenges and the healthcare reform measures of the second Trump administration will impact the ACA or operations.
−Removed: Following ACA, both the Budget Control Act of 2011 includes, among other things, mandatory reductions in Medicare payments to certain providers.
−Removed: Additionally, in the United States, there have been several recent Congressional inquiries and federal and state legislative activity designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs.
−Removed: At the federal level, the IRA, among other things, (i) directs HHS to negotiate the price of certain high-expenditure, single-sourcebiologics that have been on the market for at least 11 years covered under Medicare, and subject drug manufacturers to civil monetary penalties and a potential excise tax by offering a price that is not equal to or less than the negotiated “maximum fair price” for such drugs and biologics under the law, or the “Medicare Drug Price Negotiation Program”, and (ii) imposes rebates with respect to certain drugs and biologics covered under Medicare Part B or Medicare Part D to penalize price increases that outpace inflation.
−Removed: These provisions began to take effect progressively starting in fiscal year 2023.
−Removed: On August 15, 2024, HHS announced the agreed-upon prices of the first ten drugs that were subject to price negotiations, although the Medicare Drug Price Negotiation program is currently subject to legal challenges.
−Removed: On January 17, 2025, HHS selected fifteen additional products covered under Part D for price negotiation in 2025.
−Removed: Each year thereafter more Part B and Part D products will become subject to the Medicare Drug Price Negotiation Program.
−Removed: On December 8, 2023, the National Institute of Standards and Technology published for comment a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights which for the first time includes the price of a product as one factor an agency can use when deciding to exercise march-in rights.
−Removed: While march-in rights have not previously been exercised, it is uncertain if that will continue under the new framework.
−Removed: At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
−Removed: Additional health reform measures may continue and affect our business in unknown ways, particularly given the recent change in administration.
−Removed: The current Trump administration is pursuing policies to reduce regulations and expenditures across government including at HHS, the FDA, the Centers for Medicare & Medicaid Services, or CMS, and related agencies.
+Added: Various provisions of the Patient Protection and Affordable Care Act as amended by the Health Care and Education Reconciliation Act, or collectively, the ACA, were designed to impact the provision of, or payment for, health care in the United States.
+Added: There have been amendments to and executive, judicial and Congressional challenges to certain aspects of the ACA.
+Added: For example, on July 4, 2025, the OBBBA was signed into law, which narrowed access to ACA marketplace exchange enrollment and declined to extend the ACA enhanced advanced premium tax credits that expired at the end of 2025, which, among other provisions in the law, are anticipated to reduce the number of Americans with health insurance.
+Added: The OBBBA also is expected to reduce Medicaid spending and enrollment by implementing work requirements for some beneficiaries, capping state-directed payments, reducing federal funding, and limiting provider taxes used to fund the program.
+Added: Congress is considering proposed legislation intended to further reduce healthcare costs with alternatives to replace the expired ACA subsidies.
+Added: The current administration is pursuing policies to reduce regulations and expenditures across government agencies including at HHS, the FDA, CMS and related agencies.
These actions, presently directed by executive orders or memoranda from the Office of Management and Budget, may propose policy changes that create additional uncertainty for our business.
−Removed: These actions may include, for example, directives to reduce agency workforce, rescinding a Biden administration executive order tasking the Center for Medicare and Medicaid Innovation, or CMMI, to consider new payment and healthcare models to limit drug spending and eliminating the Biden administration’s executive order that directed HHS to establishing an AI task force and developing a strategic plan, and directing certain federal agencies to enforce existing law regarding hospital and price plan transparency and by standardizing prices across hospitals and health plans.
−Removed: Additionally, in its June 2024 decision in Loper Bright Enterprises v.
−Removed: Raimondo, or Loper Bright, the U.S.
−Removed: Supreme Court overturned the longstanding Chevron doctrine, under which courts were required to give deference to regulatory agencies’ reasonable interpretations of ambiguous federal statutes.
−Removed: The Loper Bright decision could result in additional legal challenges to current regulations and guidance issued by federal agencies applicable to our operations, including those issued by the FDA.
−Removed: Congress may introduce and ultimately pass health care related legislation that could impact the drug approval process and make changes to the Medicare Drug Price Negotiation Program created under the IRA.
−Removed: This could harm our or our collaborators’ ability to market any products and generate revenues.
−Removed: Cost containment measures that healthcare payors and providers are instituting and the effect of further healthcare reform could significantly reduce potential revenues from the sale of any of our product candidates approved in the future, and could cause an increase in our compliance, manufacturing, or other operating expenses.
+Added: For example, the current administration has announced agreements with several pharmaceutical companies that require the drug manufacturers to offer, through a direct to consumer platform, or TrumpRx, U.S.
+Added: patients and Medicaid programs prescription drug Most-Favored Nation pricing equal to or lower than those paid in other developed nations, with additional mandates for direct-to-patient discounts and repatriation of foreign revenues.
+Added: Other recent actions, for example, include (1) directing agencies to reduce agency workforce and cut programs;
+Added: (2) directing HHS and other agencies to lower prescription drug costs through a variety of initiatives;
+Added: (3) imposing tariffs on
+Added: imported pharmaceutical products;
+Added: and (4) as part of the Make America Healthy Again (“MAHA”) Commission’s Strategy Report released in September 2025, working across government agencies to increase enforcement on direct-to-consumer pharmaceutical advertising.
+Added: Additionally, the current administration recently called on Congress to enact "The Great Healthcare Plan," to codify and expand Most-Favored Nation pricing, lower government subsidies to private insurance companies, increase healthcare price transparency, expand pharmaceutical drugs available for over-the-counter purchase, and enact restrictions on pharmacy benefit manager, or PBM, payment methodologies, among other things.
+Added: These actions and policies may significantly reduce U.S.
+Added: drug prices, potentially impacting manufacturers’ global pricing strategies and profitability, while increasing their operational costs and compliance risks.
+Added: In June 2024, the U.S.
+Added: Supreme Court’s Loper Bright decision greatly reduced judicial deference to regulatory agencies, which could increase successful legal challenges to federal regulations affecting our operations.
+Added: Congress may introduce and ultimately pass health care related legislation that could impact the drug approval process and make changes to the Medicare Drug Price Negotiation Program.
In some foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed.
5 unchanged sentences
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.
−Removed: This Health Technology Assessment, or 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.
+Added: This Health Technology Assessment (“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.
1 unchanged sentence
The extent to which pricing and reimbursement decisions are influenced by the HTA of the specific medicinal product currently varies between EU Member States.
−Removed: In December 2021, Regulation No.
−Removed: 2021/2282 on Health Technology Assessment, amending Directive 2011/24/EU, was adopted in the EU.
−Removed: This Regulation, which entered into force on January 12, 2025 and has a phased implementation, is intended to boost cooperation among EU Member States in assessing health technologies, including new medicinal products, and providing the basis for cooperation at EU level for joint clinical assessments in these areas.
−Removed: The Regulation permits EU Member States to use common HTA tools, methodologies, and procedures across the EU, working together in four main areas, including joint clinical assessment of the innovative health technologies with the most potential impact for patients, joint scientific consultations whereby developers can seek advice from HTA authorities, identification of emerging health technologies to identify promising technologies early, and continuing voluntary cooperation in other areas.
+Added: On January 12, 2025, Regulation No.
+Added: 2021/2282 on Health Technology Assessment, amending Directive 2011/24/EU entered into force on January 12, 2025 through a phased implementation.
+Added: It is intended to boost cooperation among EU Member States in assessing health technologies, including new medicinal products, and establishes the framework for joint clinical assessments, joint scientific consultations, and the early identification of emerging health technologies.
+Added: The Regulation permits EU Member States to use common HTA tools, methodologies, and procedures across the EU and requires them to rely on EU-level joint clinical assessment reports for the clinical components of their national HTA 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.
11 unchanged sentences
Recommendations by government authorities or other groups and organizations may relate to such matters as usage, dosage, route of administration and use of related therapies, and a growing number of organizations are providing assessments of the value and pricing of pharmaceutical products.
−Removed: These assessments may come from private organizations, such as the Institute for Clinical and Economic Review, or ICER, which publish their findings and offer recommendations relating to the products’ reimbursement by government and private payors.
+Added: These assessments may come from private organizations, such as the Institute for Clinical and Economic Review (“ICER”) which publish their findings and offer recommendations relating to the products’ reimbursement by government and private payors.
In July 2019, ICER published its final report assessing the comparative clinical effectiveness and value of treatments for peanut allergy, including Viaskin Peanut and a competitor product candidate.
37 unchanged sentences
Restrictions under applicable federal, state and foreign healthcare laws and regulations include but are not limited to the following:
−Removed: • The federal Anti-Kickback Statute prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration (including any kickback, bribe or rebate), directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for or the purchase, lease, order or recommendation of any item, good, facility or service for which payment may be made under federal healthcare programs such as Medicare and Medicaid.
+Added: • The federal Anti-Kickback Statute prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration (including any kickback, bribe or rebate), directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for or the purchase, lease, order or recommendation of any item, good, facility or service for which payment may be made
+Added: under federal healthcare programs such as Medicare and Medicaid.
Although there are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, the exceptions and safe harbors are drawn narrowly.
3 unchanged sentences
• The federal civil and criminal false claims laws, including the civil False Claims Act, impose criminal and civil penalties, including those from civil whistleblower or qui tam actions, and civil monetary penalties laws, which prohibit, among other things, knowingly presenting, or causing to be presented, claims for payment that are false or fraudulent or making a false statement to avoid, decrease, or conceal an obligation to pay money to the federal government.
−Removed: • The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created federal criminal and civil liability for, among other things, executing a scheme to defraud any healthcare benefit program or knowingly and willingly falsifying, concealing or covering up a material fact or making false statements relating to healthcare matters.
+Added: • HIPAA, which created federal criminal and civil liability for, among other things, executing a scheme to defraud any healthcare benefit program or knowingly and willingly falsifying, concealing or covering up a material fact or making false statements relating to healthcare matters.
Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation.
−Removed: • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations, which impose certain requirements on covered entities and their business associates, and their covered subcontractors, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information.
+Added: • HIPAA, as amended by HITECH, and its implementing regulations, which impose certain requirements on covered entities and their business associates, and their covered subcontractors, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information.
• The federal transparency requirements under the Physician Payments Sunshine Act, enacted as part of the ACA, that require applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, to track and annually report to CMS payments and other transfers of value provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners), and teaching hospitals and certain ownership and investment interests held by physicians or their immediate family members in the applicable manufacturer, and disclosure of such information will be made by CMS on a publicly available website.
−Removed: • Analogous state, local or foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers;
−Removed: state and local marketing and/or transparency laws applicable to manufacturers that may be broader in scope than the federal requirements, state laws that require biopharmaceutical companies to comply with the biopharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, state and local laws that require licensure or registration of pharmaceutical sales representatives;
−Removed: state laws that require disclosure of information related to drug pricing;
+Added: • Analogous state, local or foreign laws and regulations, such as state and foreign anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers;
+Added: state and local marketing and/or transparency laws applicable to manufacturers that may be broader in scope than the federal requirements, state and foreign laws that require biopharmaceutical companies to comply with the biopharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, state and local laws that require certain regulatory licenses to manufacture or distribute our products commercially and/or registration of pharmaceutical sales representatives;
+Added: state and foreign laws that require disclosure of information related to drug pricing;
and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect as HIPAA.
7 unchanged sentences
If the physicians or other providers or entities with whom we expect to do business are found not to be in compliance with applicable laws, they may be subject to significant criminal, civil or administrative sanctions, including exclusion from government funded healthcare programs.
−Removed: Changes in regulatory requirements, or guidance from the FDA or comparable foreign regulatory authorities or unanticipated events during our clinical trials of Viaskin products may occur, which may
−Removed: result in changes to clinical trial protocols or additional clinical trial requirements, which could result in increased costs to us and could delay our development timeline.
+Added: Changes in regulatory requirements, or guidance from the FDA or comparable foreign regulatory authorities or unanticipated events during our clinical trials of Viaskin products may occur, which may result in changes to clinical trial protocols or additional clinical trial requirements, which could result in increased costs to us and could delay our development timeline.
Changes in regulatory requirements, or guidance from the FDA or comparable foreign regulatory authorities or unanticipated events during our clinical trials may force us to amend clinical trial protocols or the FDA or certain foreign regulatory authorities may impose additional clinical trial requirements.
4 unchanged sentences
For instance, the regulatory landscape related to clinical trials in the EU recently evolved.
−Removed: The EU Clinical Trials Regulation (“CTR”), which was adopted in April 2014 and repeals the EU Clinical Trials Directive (“CTD”), became applicable on January 31, 2022.
−Removed: The CTR allows sponsors to make a single submission to both the competent authority and an ethics committee in each EU Member State, leading to a single decision for each EU Member State.
−Removed: The assessment procedure for the authorization of clinical trials has been harmonized as well, including a joint assessment by all EU Member States concerned, and a separate assessment by each EU Member State with respect to specific requirements related to its own territory, including ethics rules.
−Removed: Each EU Member State’s decision is communicated to the sponsor via the centralized EU portal.
−Removed: Once the clinical trial approved, clinical study development may proceed.
+Added: T he EU Clinical Trials Regulation ("CTR"), which was adopted in April 2014 and repeals the EU Clinical Trials Directive, became applicable on January 31, 2022.
+Added: The CTR introduces, among other changes, a centralized application system, coordinated review procedures, expanded reporting and increased transparency obligations.
The CTR foresaw a three-year transition period that ended on January 31, 2025.
Since this date, all new or ongoing trials are subject to the provisions of the CTR.
−Removed: Compliance with the CTR requirements by us and our third party service providers, such as CROs, may impact our development plans
−Removed: In light of the entry into application of the CTR on January 31, 2022, we may be required to transition clinical trials for which we have obtained regulatory approvals in accordance with the CTD to the regulatory framework of the CTR.
−Removed: Transition of clinical trials governed by the CTD to the CTR was required for clinical trials which had at least one site active in the EU on January 30, 2025.
−Removed: A transitioning application had to be submitted to the competent authorities of EU Member States through the Clinical Trials Information Systems and related regulatory approval obtained to continue the clinical trial past January 30, 2025.
−Removed: This required financial, technical and human resources.
−Removed: It is currently unclear to what extent the UK will seek to align its regulations with the EU in the future.
−Removed: The UK regulatory framework in relation to clinical trials is derived from existing EU legislation (as implemented into UK law, through secondary legislation).
−Removed: On January 17, 2022, the UK Medicines and Healthcare products Regulatory Agency, or MHRA, launched an eight-week consultation on reframing the UK legislation for clinical trials.
−Removed: The UK Government published its response to the consultation on March 21, 2023 confirming that it would bring forward changes to the legislation and such changes were laid in parliament on December 12, 2024.
−Removed: These resulting legislative amendments will, if implemented in their current form, bring the UK into closer alignment with the CTR.
−Removed: Failure of the UK to closely align its regulations with the EU may have an effect on the cost of conducting clinical trials in the UK as opposed to other countries and/or make it harder to seek a marketing authorization for our product candidates on the basis of clinical trials conducted in the UK.
+Added: Compliance with the CTR requirements by us and our third-party service providers, such as CROs, required financial, technical and human resources
+Added: Moreover, following a public consultation that began in 2022, the United Kingdom government has enacted new legislation to overhaul the clinical trials regulatory framework.
+Added: In April 2025, the UK adopted an amendment to the Medicines for Human Use (Clinical Trials) Regulations 2004 intended to support a more streamlined and flexible regulation of clinical trials, remove unnecessary administrative burdens on trial sponsors, and protect the interests of trial participants.
+Added: It also intends to bring the UK regulatory framework for clinical trials into closer alignment with the CTR.
+Added: The amendment will become applicable on April 28, 2026 following a one-year transition period.
+Added: While these changes introduce efficiencies and align with some principles of the CTR, divergence between the United Kingdom and EU regulatory systems remains.
+Added: Any significant divergence could affect the cost and complexity of conducting clinical trials in the United Kingdom and may impact the acceptability of United Kingdom-based trial data for seeking marketing authorizations in the EU, and vice versa.
+Added: In addition, on December 11, 2025, the European Commission, the Parliament and the European Council reached a political agreement on a comprehensive overhaul of EU pharmaceutical legislation (the “Pharma Package”).
+Added: The reform has been under negotiation since the European Commission submitted its proposal in April 2023.
+Added: This package - comprised of a new directive and regulation to replace existing legislation – aims to modernize the EU framework.
+Added: The political agreement is still subject to formal approval by the European Parliament and Council.
+Added: If approved in the form proposed, the Pharma Package will, among other changes, reduce the baseline market protection period by one year, with limited opportunities for extensions;
+Added: reshape the incentives regime for orphan medicinal products;
+Added: and expand the Bolar exemption.
+Added: A decrease in market exclusivity opportunities for our product candidates in the EU, combined with the expanded Bolar exemption, could open them to generic or biosimilar competition earlier than under the current regime, potentially impacting reimbursement status and the commercial prospects of our product candidates.
If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies governing clinical trials, our development plans may be impacted.
20 unchanged sentences
If we do commence clinical trials of our other potential product candidates, such product candidates may never be approved by the FDA or comparable foreign regulatory authorities.
−Removed: these events occur, we may be forced to abandon our development efforts for a program or programs, which would have a material adverse effect on our business and could potentially cause us to cease operations.
+Added: If any of these events occur, we may be forced to abandon our development efforts for a program or programs, which would have a material adverse effect on our business and could potentially cause us to cease operations.
If we do not secure collaborations with strategic partners to test, commercialize and manufacture certain product candidates outside of food allergies, we may not be able to successfully develop products and generate meaningful revenues.
18 unchanged sentences
If we are unable to secure new collaborations that achieve the collaborator’s objectives and meet our expectations, we may be unable to advance our product candidates and may not generate meaningful revenues.
+Added: Managing Growth and Transitioning to the Commercial Phase.
+Added: In December 2025, DBV reported positive preliminary results from the Phase 3 VITESSE study of the Viaskin Peanut patch in children aged 4 to 7 with peanut allergies, reinforcing the preparation for the next regulatory steps.
+Added: DBV has thus entered an acceleration phase characterized by (i) the continued advanced clinical development of Viaskin® Peanut, (ii) the preparation of the BLA in the United States, and (iii) the establishment of pre-commercial and commercial capabilities, subject to regulatory approvals.
+Added: This transition entails a substantial increase in operational capacity (quality, regulatory affairs, clinical operations, supply chain, manufacturing in a regulated environment, market access, pharmacovigilance, and medical information) and a scaling up of human, financial, and information system resources.
+Added: A poorly managed ramp-up could lead to delays, cost overruns, regulatory non-compliance, a deterioration in quality metrics, and failures in the coordination of service providers and suppliers.
+Added: The transition from an R&D-focused model to one that incorporates pre-marketing and, where applicable, the marketing of Viaskin® Peanut requires, in particular:
+Added: • ongoing compliance of internal control systems and manufacturing processes with local and federal requirements;
+Added: • securing and ensuring redundancy in the supply chain (raw materials, components, production sites);
+Added: • the ability to forecast demand, plan batches, and manage distribution;
+Added: • the activation of market access, medical affairs, and pharmacovigilance functions, as well as the management of post-marketing safety data, where applicable.
+Added: Any shortfall in any of these areas could delay or jeopardize the achievement of regulatory/commercial milestones, significantly increase costs, and damage DBV’s reputation.
+Added: Furthermore, the Company is not currently generating revenue and has historically recorded significant operating losses.
+Added: The commercialization phase of the VIASKIN Peanut patch for children aged 4 to 7 in the United States remains contingent upon access to additional financing, which may not be available in a timely manner, on acceptable terms, or may result in substantial dilution of existing shareholders.
+Added: The materialization of all or part of the above risks could:
+Added: (i) delay submissions or prolong regulatory reviews, (ii) delay the industrial ramp-up, (iii) increase expenses beyond forecasts, (iv) reduce financial flexibility, and, generally, have a material adverse effect on DBV’s business, financial condition, results, and prospects.
Intellectual Property Risks Related to Our Business
17 unchanged sentences
There are many issued U.S.
−Removed: and foreign patents relating to biological or chemical compounds and therapeutic products, and some of these relate to compounds we intend to commercialize.
+Added: and foreign patents relating to
+Added: biological or chemical compounds and therapeutic products, and some of these relate to compounds we intend to commercialize.
Numerous U.S.
17 unchanged sentences
The interpretation and breadth of claims allowed in some patents covering biopharmaceutical compositions may be uncertain and difficult to determine, and are often affected materially by the facts and circumstances that pertain to the patented compositions and the related patent claims.
−Removed: The standards of the United States Patent and Trademark Office, or USPTO, are sometimes uncertain and could change in the future.
+Added: The standards of the USPTO are sometimes uncertain and could change in the future.
Consequently, the issuance and scope of patents cannot be predicted with certainty.
Patents, if issued, may be challenged, invalidated or circumvented.
−Removed: patents and patent applications may also be subject to interference proceedings;
+Added: patents and patent applications may also be subject to interference or derivation proceedings;
patents may be subject to reexamination proceedings, post-grant review and/or inter partes review in the USPTO (collectively, “post-grant proceedings”).
Foreign patents may be subject also to opposition or comparable proceedings in the corresponding foreign patent office, which could result in either loss of the patent or denial of the patent application or loss or reduction in the scope of one or more of the claims of the patent or patent application.
−Removed: In addition, such interference, reexamination, post-grant review, inter partes review and opposition proceedings may be costly.
+Added: In addition, such interference, derivation, reexamination, post-grant review, inter partes review and opposition proceedings may be costly.
Accordingly, rights under any issued patents may not provide us with sufficient protection against competitive products or processes.
2 unchanged sentences
laws and those countries may lack adequate rules and procedures for defending our intellectual property rights.
−Removed: If we fail to obtain and maintain patent protection and trade secret protection of our product candidates, we could lose our competitive advantage and competition we face would increase, reducing any potential revenues and adversely affecting our ability to attain or maintain profitability.
+Added: If we fail to obtain and maintain patent protection and trade secret protection of our product candidates, we could lose our competitive advantage and competition we face could increase, reducing any potential revenues and adversely affecting our ability to attain or maintain profitability.
Developments in patent law could have a negative impact on our business.
2 unchanged sentences
Any rulings that make it more difficult to uphold the validity of biological or chemical “genus” claims could potentially negatively impact our patent portfolio and negatively impact our business.
−Removed: In addition, the Leahy-Smith America Invents Act, or the America Invents Act, which was signed into law in 2011, includes a number of significant changes to U.S.
+Added: In addition, the Leahy-Smith America Invents Act (the “America Invents Act”) which was signed into law in 2011, includes a number of significant changes to U.S.
These changes include a transition from a “first-to-invent” system to a “first-to-file” system, changes to the way issued patents are challenged, and changes to the way patent applications are disputed and prosecuted during the examination process.
6 unchanged sentences
For example, bills have been introduced that would reduce the discretion of the Patent Trial and Appeal Board (“PTAB”) to deny some or all post-grant proceedings.
−Removed: In addition, bills, rules and/or regulations have been introduced that would provide the director of the U.S.P.T.O more authority to set aside PTAB decisions.
+Added: In addition, bills, rules and/or regulations have been introduced that would and do provide the director of the USPTO more authority to set aside PTAB decisions.
+Added: Further, at least one other bill has been introduced that would essentially revert the patent system to the pre-America Invents Act patent system.
If these bills are eventually passed by the U.S.
29 unchanged sentences
In these countries, patents may provide limited or no benefit.
−Removed: Patent protection must ultimately be sought on a country-by-country basis, which is an expensive and time-consuming process with uncertain outcomes.
+Added: Patent protection must ultimately be sought on a country-by-country or jurisdiction-by-jurisdiction basis, which is an expensive and time-consuming process with uncertain outcomes.
Accordingly, we may choose not to seek patent protection in certain countries, and we will not have the benefit of patent protection in such countries.
23 unchanged sentences
A patentee could prevent us from using the patented drugs or compositions.
−Removed: We may need to resort to litigation to enforce a patent issued to us, to protect our trade secrets, or to determine the scope and validity of third-party proprietary rights.
+Added: We may need to resort to litigation to enforce a patent issued to us, to protect
+Added: our trade secrets, or to determine the scope and validity of third-party proprietary rights.
From time to time, we may hire scientific personnel or consultants formerly employed by other companies involved in one or more areas similar to the activities conducted by us.
17 unchanged sentences
Even if we are successful in these proceedings, we may incur substantial costs and divert management time and attention in pursuing these proceedings, which could have a material adverse effect on us.
−Removed: If we are unable to avoid infringing the patent rights of others, we may be required to seek a license, defend an infringement action or challenge the validity of the patents in court, or redesign our products.
+Added: If we are unable to avoid infringing the patent rights of others, we may be required to seek a license, defend an infringement action or challenge the validity or enforceability of the patents in court, or redesign our products.
Patent litigation is costly and time consuming.
10 unchanged sentences
Grounds for a validity challenge include alleged failures to meet any of several statutory requirements, including lack of novelty, obviousness or non-enablement.
−Removed: Grounds for unenforceability assertions include allegations of lack of candor or good faith in dealing with USPTO, that someone connected with prosecution of the patent withheld relevant and/or materials information from the USPTO, or made a misleading statement, during prosecution.
+Added: Grounds for unenforceability assertions include allegations of lack of candor or good faith in dealing with USPTO, that someone connected with prosecution of the patent withheld relevant and/or material information from the USPTO, or made a false statement, during prosecution.
Third parties may also raise similar claims regarding invalidity and/or unenforceability before administrative bodies in the United States or abroad, even outside the context of litigation.
10 unchanged sentences
The loss of the services of any of these individuals would likely have an adverse effect on us.
−Removed: Our success also will depend upon our ability to attract and retain additional qualified management.
+Added: Our success also will depend upon our ability to attract and retain additional qualified
Recruiting and retaining qualified scientific, clinical, manufacturing, sales and marketing personnel will also be critical to our success.
34 unchanged sentences
We maintain liability insurance;
−Removed: however, if any
−Removed: costs or expenses associated with this or any other litigation exceed our insurance coverage, we may be forced to bear some or all of these costs and expenses directly, which could be substantial.
+Added: however, if any costs or expenses associated with this or any other litigation exceed our insurance coverage, we may be forced to bear some or all of these costs and expenses directly, which could be substantial.
We may be subject to legal or administrative proceedings and litigation other than product liability lawsuits which may be costly to defend and could materially harm our business, financial condition and operations.
5 unchanged sentences
Our failure to maintain certain tax benefits applicable to French technology companies may adversely affect our Operating Income
−Removed: As a French technology company, we have benefited from certain tax advantages, including, for example, the French Research Tax Credit ( crédit d’impôt recherche ), or CIR.
+Added: We may be subject to tax reviews and audits relating to (i) the determination and allocation of the tax loss (including its carryforward status and the proper documentation of its constituent elements) and (ii) the transfer pricing policy applied within the Company (methodology, comparables, value chain, allocation of functions/assets/risks, and consistency with contractual cash flows).
+Added: These audits may be conducted retrospectively and cover several fiscal years.
+Added: The tax authorities assess the Company’s practices in compliance with the tax rules in force in the relevant jurisdictions and with generally accepted arm's length principles.
+Added: The Company has a tax loss in France of approximately $1.5 billion and $3 million in the United States as of December 31, 2025.
+Added: As a French technology company, we have benefited from certain tax advantages, including, for example, the French Research Tax Credit ( crédit d’impôt recherche ) (“CIR”).
The CIR is a French tax credit aimed at stimulating research and development.
1 unchanged sentence
The CIR is calculated based on our claimed amount of eligible research and development expenditures in France and represented $5.6 million and $4.2 million, as of December 31, 2025 and 2024 respectively.
−Removed: The French tax authority with the assistance of the Research and Technology Ministry may audit each research and development program in respect of which a CIR benefit has been claimed and assess whether such program qualifies in its view for the CIR benefit.
+Added: The French tax authority with the assistance of the Research and Technology Ministry may audit each research and development program in respect of which a CIR benefit has been claimed and assess whether such program qualifies in its view for the CIR tax benefit or could not grant Tax agreement to our Contract Research Organizations.
The French tax authorities may challenge our eligibility to, or our calculation of certain tax reductions and/or deductions in respect of our research and development activities and, should the French tax authorities be successful, we may be liable to additional corporate income tax, and penalties and interest related thereto, which could have a significant impact on our results of operations and future cash flows.
2 unchanged sentences
Exchange rate fluctuations may adversely affect the foreign currency value of our ADSs.
−Removed: We incur portions of our expenses, and may in the future derive revenues, in currencies other than the euro, in particular, the U.S.
+Added: We are exposed to increasing foreign exchange risk due to a portion of our supplies sourced in the United States and invoiced in U.S.
+Added: dollars, as well as the operations of our subsidiary DBV Technologies Inc., given our preparations for the potential launch of the VIASKIN Peanut patch in the United States, should it receive FDA approval.
As a result, we are exposed to foreign currency exchange risk as our results of operations and cash flows are subject to fluctuations in foreign currency exchange rates.
−Removed: We currently do not engage in hedging transactions to protect against uncertainty in future exchange rates between particular foreign currencies and the euro.
−Removed: Therefore, for example, an increase in the value of the euro against the U.S.
−Removed: dollar could be expected to have a negative impact on our revenue and earnings growth as U.S.
−Removed: dollar revenue and earnings, if any, would be translated into euros at a reduced value.
−Removed: We cannot predict the impact of foreign currency fluctuations, and foreign currency fluctuations in the future may adversely affect our financial condition, results of operations and cash flows.
+Added: This exposure is exacerbated by the high level of volatility of the U.S.
+Added: dollar over the past year, which increases uncertainty regarding foreign exchange transaction costs.
The ADSs are quoted in U.S.
dollars on the Nasdaq Capital Market and our ordinary shares are trading in euros on Euronext Paris.
−Removed: Our financial statements are prepared in euros.
+Added: Our financial statements are prepared in U.S.
Fluctuations in the exchange rate between euros and the U.S.
1 unchanged sentence
dollar value and the euro value of our ordinary shares and ADSs.
+Added: Climate change, extreme weather events, and evolving sustainability regulations could disrupt our third‑party CRO/CMO and supplier operations, increase costs, and delay our development and manufacturing timelines.
+Added: The increased frequency of extreme weather events (fires, floods, storms, heat waves) could disrupt the operations of the CROs and CMOs that we use.
+Added: Such disruptions could delay the manufacturing of clinical batches, the delivery of research devices, or the conduct of clinical trials, impacting execution timelines.
+Added: Transition risks include the implementation of stricter emissions or sustainability regulations, which could increase costs or lead times for suppliers and industrial partners.
+Added: These developments could indirectly affect the availability and cost of services necessary for the development of DBV's product candidates.
+Added: The Company is not subject to the CSRD reporting obligations or the CS3D (CSDDD) due diligence obligations at this stage, given the reduced scope and postponement of application phases decided at the European level under the Omnibus Directive and the “Stop-the-Clock” mechanism (a two-year delay for phases 2 and 3;
+Added: refocusing on companies with more than 1,000 employees and more than €450 million in revenue).
+Added: The Group maintains formal regulatory monitoring (EU/France) to incorporate expected clarifications on the Omnibus Directive and the revised ESRS, and to adapt its practices should its status change.
+Added: In the United States, regulatory bodies do not yet provide for sustainability obligations for issuers at this stage.
We may use hazardous chemicals and biological materials in our business.
5 unchanged sentences
We may be sued for any injury or contamination that results from our use or the use by third parties of these materials, and our liability may exceed any insurance coverage and our total assets.
−Removed: Federal, state, local or foreign laws and regulations govern the use, manufacture, storage, handling and disposal of these hazardous materials and specified waste products, as well as the discharge of pollutants into the environment and human health and safety matters.
+Added: Federal, state, local or foreign laws and
+Added: regulations govern the use, manufacture, storage, handling and disposal of these hazardous materials and specified waste products, as well as the discharge of pollutants into the environment and human health and safety matters.
An allegation of noncompliance by applicable regulatory authorities with environmental laws and regulations may be expensive and may impair our research and development efforts.
4 unchanged sentences
In the ordinary course of business, we collect, receive, store, process, generate, use, transfer, disclose, make accessible, protect, secure, dispose of, transmit, and share (collectively, processing) personal data and other sensitive information, including proprietary and confidential business data, trade secrets, intellectual property, data we collect about trial participants in connection with clinical trials, and sensitive third-party data.
−Removed: Our data processing
−Removed: activities subject us to numerous data privacy and security obligations, such as various laws, regulations, guidance, industry standards, external and internal privacy and security policies, contractual requirements, and other obligations that govern the processing of personal data by us and on our behalf.
−Removed: In the United States, federal, state, and local governments have enacted numerous data privacy and security laws, including data breach notification laws, personal data privacy laws, and consumer protection laws.
+Added: Our data processing activities subject us to numerous data privacy and security obligations, such as various laws, regulations, guidance, industry standards, external and internal privacy and security policies, contractual requirements, and other obligations that govern the processing of personal data by us and on our behalf.
+Added: In the United States, federal, state, and local governments have enacted numerous data privacy and security laws, including data breach notification laws, personal data privacy laws, consumer protection laws, and other similar laws (e.g., wiretapping laws).
For example, HIPAA, as amended by HITECH, imposes specific requirements relating to the privacy, security, and transmission of individually identifiable health information.
−Removed: In addition, the California Consumer Privacy Act of 2018, or CCPA, imposes obligations on covered businesses.
+Added: In addition, , numerous states have enacted comprehensive privacy laws that impose certain obligations on covered businesses, including providing specific disclosures in privacy notices and affording residents with certain rights concerning their personal data.
+Added: As applicable, such rights may include the right to access, correct, or delete certain personal data, and to opt-out of certain data processing activities.
+Added: The exercise of these rights may impact our business and ability to provide our products and services.
+Added: Certain states also impose stricter requirements for processing certain personal data, including sensitive information, such as conducting data privacy impact assessments.
+Added: These states allow for statutory fines for noncompliance.
+Added: For example, the California Consumer Privacy Act of 2018 (“CCPA”_ applies to personal data of consumers, business representatives, and employees who are California residents, and imposes obligations on covered businesses.
These obligations include, but are not limited to, providing specific disclosures in privacy notices and affording California residents certain rights related to their personal data.
The CCPA allows for statutory fines for noncompliance (up to $7,500 per violation).
−Removed: Although the CCPA exempts some data processed in the context of clinical trials, the CCPA may increase compliance costs and potential liability with respect to other personal data we maintain about California residents.
−Removed: In addition, it is anticipated that the California Privacy Rights Act of 2020, CPRA, effective January 1, 2023, has expanded the CCPA.
−Removed: The CPRA establishes a new California Privacy Protection Agency to implement and enforce the CPRA, which could increase the risk of enforcement.
−Removed: Other states have enacted data privacy laws.
−Removed: For example, Virginia passed the Consumer Data Protection Act, and Colorado passed the Colorado Privacy Act, both of which become effective in 2023.
−Removed: In addition, data privacy and security laws have been proposed at the federal, state, and local levels in recent years, which could further complicate compliance efforts.
+Added: Although the CCPA and other comprehensive U.S.
+Added: state privacy laws exempt some data processed in the context of clinical trials, these developments may increase compliance costs and potential liability with respect to other personal data we maintain about California residents.In addition, similar laws are being considered in several other states, as well as at the federal, state, and local levels, and we expect more states to pass similar laws in the future.
Outside the United States, an increasing number of laws, regulations, and industry standards apply to data privacy and security.
−Removed: For example, the European Union’s General Data Protection Regulation, or EU GDPR, and the United Kingdom’s GDPR, or UK GDPR, impose strict requirements for processing personal data.
−Removed: For example, under the EU GDPR, government regulators may impose temporary or definitive bans on data processing, as well as fines of up to €20 million or 4% of the total annual global revenue of the preceding year, whichever is greater.
−Removed: Furthermore, companies may face private litigation related to processing of personal data brought by data subjects, classes of data subjects or consumer protection organizations authorized at law to represent their interests.
+Added: For example, the EU GDPR and the UK GDPR impose strict requirements for processing personal data.
+Added: For example, under the GDPR, government regulators may impose temporary or definitive bans on data processing and other corrective actions, fines of up to €20 million under the EU GDPR, 17.5 million pounds sterling under the UK GDPR or, in each case, 4% of annual global revenue , whichever is greater.
+Added: Furthermore, companies may face private litigation related to processing of personal data brought by classes of data subjects or consumer protection organizations authorized at law to represent their interests.
Certain jurisdictions have enacted data localization laws and cross-border personal data transfer laws, which could make it more difficult to transfer information across jurisdictions (such as transferring or receiving personal data that originates in the European Economic Area, or EEA, or in other foreign jurisdictions).
−Removed: Although there are currently various mechanisms that may be used to transfer personal data from the EEA and UK to the United States in compliance with law, these mechanisms are subject to legal challenges, and there is no assurance that we can satisfy or rely on these measures to lawfully transfer personal data to the United States on a long-term basis.
−Removed: The EU GDPR generally restricts the transfer of personal data to countries outside of the European Economic Area, or EEA, such as the United States.
−Removed: The European Commission adopted an adequacy decision for the EU-US Data Privacy Framework, or DPF, on July 10, 2023, further to the Biden Administration’s Executive Order dated October 7, 2022 which provides that entities in the EEA may transfer personal data to entities in the United States that adhere and comply with the DPF without having to implement additional safeguards.
−Removed: However, the DPF is may not provide adequate protection given the previous successive invalidations of previously EU-US adequacy mechanisms and the periodic review of the DPF by the European Commission.
−Removed: The European Commission released a set of “Standard Contractual Clauses,” or SCCs, that are designed to be a valid mechanism to facilitate personal data transfers out of the EEA to these jurisdictions.
−Removed: These SCCs can be a valid mechanism to transfer personal data outside of the EEA.
−Removed: However, only entering into SCCs may not be sufficiency and additional compliance burdens are required, such as conducting transfer impact assessments to determine whether additional security measures are necessary to protect the at-issue personal data.
−Removed: In addition, Switzerland and the UK similarly restrict personal data transfers outside of those jurisdictions to countries, such as the United States, and certain countries outside Europe (e.g., Russia, China, Brazil) have also passed or are considering laws requiring local data residency or otherwise impeding the transfer of personal data across borders, any of which could increase the cost and complexity of doing business.
−Removed: If we cannot transfer personal data from the EEA, the UK or other jurisdictions to the United States in a lawful manner, or if the costs for such lawful transfers of personal data are too high, we may face increased exposure to regulatory actions, substantial fines and penalties, and injunctions against processing or transferring personal data from Europe or other foreign jurisdictions.
−Removed: The inability to import personal data to the United States could significantly and negatively impact our business operations;
−Removed: limiting our ability to collaborate with parties that are subject to such cross-border data transfer or localization laws;
−Removed: or requiring us to increase our personal data processing capabilities and infrastructure in foreign jurisdictions at significant expense;
−Removed: or interrupting or adversely impacting our operations.
−Removed: Our obligations related to data privacy and security are quickly changing in an increasingly stringent fashion, creating some uncertainty as to the effective future legal framework.
+Added: Although there are currently various mechanisms that may be used to transfer personal data from the EEA and UK to the United States in compliance with law, , such as the European standard contractual clauses, the UK’s International Data Transfer Agreement / Addendum, and the EU-U.S.
+Added: Data Privacy Framework and the UK extension thereto (which allows for transfers to relevant U.S.-based organizations who self-certify compliance and participate in the Framework), these mechanisms are subject to legal challenges, and there is no assurance that we can satisfy or rely on these measures to lawfully transfer personal data to the United States.
+Added: Other countries outside Europe (e.g., Russia, China, Brazil) have also passed or are considering laws requiring local data residency or otherwise impeding the transfer of personal data across borders, any of which could increase the cost and complexity of doing business.
+Added: If we cannot transfer personal data from one jurisdiction to another, for example, from the EEA, the UK or other jurisdictions to the United States in a lawful manner, or if the requirements for such lawful transfers of personal data are too onerous, we may face significant adverse consequences, including the interruption or degradation of our operations, the need to relocate part or all of our business or data processing activities to other jurisdictions (such as Europe) at significant expense, increased exposure to regulatory actions, substantial fines and penalties, and injunctions against processing or transferring personal data from Europe or other foreign jurisdictions, the inability to transfer data and collaborate with partners, vendors, and other third parties.
+Added: Additionally, the U.S.
+Added: Department of Justice issued a rule entitled Preventing Access to U.S.
+Added: Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons, which places additional restrictions on certain data transactions involving countries of concern (e.g., China, Russia, Iran) and covered individuals (i.e., individuals and entities located in or controlled by individuals or entities located in those jurisdictions) that may impact certain business activities such as vendor engagements, employment of certain individuals and investor agreements.
+Added: Violations of the rule could lead to significant civil and criminal fines and penalties.
+Added: The rule applies regardless of whether data is anonymized, key-coded, pseudonymized, de-identified or encrypted.
+Added: We are also bound by contractual obligations related to data privacy and security, and our efforts to comply with such obligations may not be successful.
+Added: We publish privacy policies, marketing materials, and other statements, concerning data privacy, and security.
+Added: Regulators in the United States are increasingly scrutinizing these statements, and if these policies, materials or statements are found to be deficient, lacking in transparency, deceptive, unfair, misleading, or misrepresentative of our practices, we may be subject to investigation, enforcement actions by regulators or other adverse consequences.
+Added: Our obligations related to data privacy and security (and consumers’ data privacy expectations) are quickly changing in an increasingly stringent fashion, creating some uncertainty as to the effective future legal framework.
Additionally, these obligations may be subject to differing applications and interpretations, which may be inconsistent or conflict among jurisdictions.
1 unchanged sentence
Although we endeavor to comply with all applicable data privacy and security obligations, we may at times fail (or be perceived to have failed) to do so.
−Removed: Moreover, despite our efforts, our personnel or third parties upon whom we rely may fail to comply with such obligations, which could negatively impact our business operations and compliance posture.
+Added: Moreover, despite our efforts, our personnel or third parties with whom we work may fail to comply with such obligations, which could negatively impact our business operations and compliance posture.
For example, any failure by a third-party processor to comply with applicable law, regulations, or contractual obligations including, providing appropriate notice to data subjects, obtaining necessary consents, or establishing a legal basis for the transfer and processing of the data by us, could result in adverse effects, including inability to or interruption in our ability to operate our business and proceedings against us by governmental entities or others.
−Removed: If we fail, or are perceived to have failed, to address or comply with data privacy and security obligations, we could face significant consequences.
+Added: If we or the third parties with whom we work fail, or are perceived to have failed, to address or comply with data privacy and security obligations, we could face significant consequences.
These consequences may include, but are not limited to, government enforcement actions (e.g., investigations, fines, penalties, audits, inspections, and similar);
−Removed: litigation (including class-related claims);
+Added: litigation (including class-related claims) and mass arbitration demands;
additional reporting requirements and/or oversight;
payment of damages;
−Removed: bans on processing personal data;
−Removed: and orders to destroy or not use personal data.
+Added: bans or restrictions on processing personal data;
+Added: orders to destroy or not use personal data;
+Added: and imprisonment of company officials.
+Added: In particular, plaintiffs have become increasingly more active in bringing privacy-related claims against companies, including class claims and mass arbitration demands.
+Added: Some of these claims allow the recovery of statutory damages on a per violation basis, and, if viable, carry the potential for monumental statutory damages, depending on the volume of data and the number of violations.
Any of these events could have a material adverse effect on our reputation, business, or financial condition, including but not limited to:
9 unchanged sentences
If our information technology systems or sensitive information, or those of third parties upon which we rely, are or were compromised, we could experience adverse consequences resulting from such compromise, including, but not limited to, regulatory investigations or actions, litigation, fines and penalties, disruptions of our business operations, reputational harm, loss of revenue or profits, and other adverse consequences.
−Removed: In the ordinary course of our business, we and the third parties upon which we rely, may process proprietary, confidential, and sensitive data, including personal data (such as health-related data), intellectual property, and trade secrets (collectively, sensitive information).
−Removed: We may rely upon third-party service providers and technologies to operate critical business systems to process sensitive information in a variety of contexts, including, without
−Removed: limitation, third-party providers of cloud-based infrastructure, encryption and authentication technology, employee email, and other functions.
+Added: In the ordinary course of our business, we and the third parties with whom we work, may process proprietary, confidential, and sensitive data, including personal data (such as health-related data), intellectual property, and trade secrets (collectively, sensitive information).
+Added: We may rely upon third-party service providers and technologies to operate critical business systems to process sensitive information in a variety of contexts, including, without limitation, third-party providers of cloud-based infrastructure, encryption and authentication technology, employee email, and other functions.
Our ability to monitor these third parties’ information security practices is limited, and these third parties may not have adequate information security measures in place.
1 unchanged sentence
While we may be entitled to damages if our third-party service providers fail to satisfy their privacy or security-related obligations to us, any award may be insufficient to cover our damages, or we may be unable to recover such award.
−Removed: Cyberattacks, malicious internet-based activity, and online and offline fraud threaten the confidentiality, integrity, and availability of our sensitive information and information technology systems, and those of the third parties upon which we rely.
+Added: Cyberattacks, malicious internet-based activity, and online and offline fraud threaten the confidentiality, integrity, and availability of our sensitive information and information technology systems, and those of the third parties with whom we work.
These threats are prevalent and continue to increase.
1 unchanged sentence
Some actors now engage and are expected to continue to engage in cyber-attacks, including, without limitation, nation-state actors for geopolitical reasons and in conjunction with military conflicts and defense activities.
−Removed: During times of war and other major conflicts, we and the third parties upon which we rely may be vulnerable to a heightened risk of these attacks, including cyber-attacks that could materially disrupt our systems and operations, supply chain, and ability to produce, sell and distribute our products.
−Removed: We and the third parties upon which we rely may be subject to a variety of evolving threats, including, but not limited to, social-engineering attacks (including through phishing attacks), malicious code (such as viruses and worms), malware (including as a result of advanced persistent threat intrusions), denial-of-service attacks (such as credential stuffing), credential harvesting, personnel misconduct or error, ransomware attacks, supply-chain attacks, software bugs, server malfunctions, software or hardware failures, loss of data or other information technology assets, adware, telecommunications failures, earthquakes, fires, flood and other similar threats.
−Removed: Severe ransomware attacks, including by organized criminal threat actors, nation-states, and nation-state-supported actors, are becoming increasingly prevalent and severe and can lead to significant interruptions in our operations, loss of data and income, reputational harm, and diversion of funds.
+Added: During times of war and other major conflicts, we and the third parties with whom we work may be vulnerable to a heightened risk of these attacks, including retaliatory cyber-attacks that could materially disrupt our systems and operations, supply chain, and ability to produce, sell and distribute our products.
+Added: We and the third parties with whom we work may be subject to a variety of evolving threats, including, but not limited to, social-engineering attacks (including through deep fakes, which may be increasingly more difficult to identify as fake, and phishing attacks), malicious code (such as viruses and worms), malware (including as a result of advanced persistent threat intrusions), denial-of-service attacks (such as credential stuffing), credential harvesting, personnel misconduct or error, ransomware attacks, supply-chain attacks, software bugs, server malfunctions, software or hardware failures, loss of data or other information technology assets, adware, telecommunications failures, earthquakes, fires, flood, attacks enhanced or facilitated by artificial intelligence, and other similar threats.
+Added: Severe ransomware attacks, including by organized criminal threat actors, nation-states, and nation-state-supported actors, are becoming increasingly prevalent and severe and can lead to significant interruptions in our operations, loss of sensitive data and income, reputational harm, and diversion of funds.
Extortion payments may alleviate the negative impact of a ransomware attack, but we may be unwilling or unable to make such payments due to, for example, applicable laws or regulations prohibiting such payments.
−Removed: Similarly, supply-chain attacks have increased in frequency and severity, and we cannot guarantee that third parties and infrastructure in our supply chain or our third-party partners’ supply chains have not been compromised or that they do not contain exploitable defects or bugs that could result in a breach of or disruption to our information technology systems or the third-party information technology systems that support us and our services.
+Added: It may be difficult and/or costly to detect, investigate, mitigate, contain, and remediate a security incident.
+Added: Our efforts to do so may not be successful.
+Added: Actions taken by us or the third parties with whom we work to detect, investigate, mitigate, contain, and remediate a security incident could result in outages, data losses, and disruptions of our business.
+Added: Threat actors may also gain access to other networks and systems after a compromise of our systems.
+Added: For example, threat actors may use an initial compromise of one part of our environment to gain access to other parts of our environment, or leverage a compromise of our networks or systems to gain access to the networks or systems of third parties with whom we work, such as through phishing or supply chain attacks.
+Added: Supply-chain attacks have increased in frequency and severity, and we cannot guarantee that third parties and infrastructure in our supply chain or our third-party partners’ supply chains have not been compromised or that they do not contain exploitable defects or bugs that could result in a breach of or disruption to our information technology systems or the third-party information technology systems that support us and our services.
Additionally, our workforce’s use of network connections, computers, and devices outside our premises or networks, including working remotely from home, while in transit, and in public locations, poses increased risks to our information technology systems and data.
1 unchanged sentence
Furthermore, we may discover security issues that were not previously identified while conducting due diligence acquired or integrated entities and it may be difficult to integrate companies into our information technology environment and security program.
−Removed: Any of the previously identified or similar threats could cause a security incident or other interruption that could result in unauthorized, unlawful, or accidental acquisition, modification, destruction, loss, alteration, encryption, disclosure of, or access to sensitive information held by us or our information technology systems, or those of the third parties upon whom we rely.
−Removed: A security incident or other interruption disrupt our ability (and that of third parties upon whom we rely) to conduct our business operations.
+Added: Any of the previously identified or similar threats could cause a security incident or other interruption that could result in unauthorized, unlawful, or accidental acquisition, modification, destruction, loss, alteration, encryption, disclosure of, or access to sensitive information held by us or our information technology systems, or those of the third parties with whom we work.
+Added: A security incident or other interruption disrupt our ability (and that of third parties with whom we work) to conduct our business operations.
We may expend significant resources or modify our business activities to try to protect against security incidents.
1 unchanged sentence
While we have implemented security measures designed to protect against security incidents, there can be no assurance that these measures will be effective.
−Removed: We take steps to detect and remediate vulnerabilities but we may not be able to detect and remediate all vulnerabilities because threats and techniques used to exploit the vulnerability change frequently, are often sophisticated in nature.
+Added: We take steps to detect, mitigate, and remediate vulnerabilities in our information systems (such as our hardware and/or software, including that of the third parties with whom we work).
+Added: We have not and may not be able to detect and remediate all such vulnerabilities including on a timely basis because threats and techniques used to exploit the vulnerability change frequently and are often sophisticated in nature.
Therefore, such vulnerabilities could be exploited but may not be detected until after a security incident has occurred.
1 unchanged sentence
Further, we may experience delays in developing and deploying remedial measures designed to address any such identified vulnerabilities.
−Removed: Applicable data privacy and security obligations may require us to notify relevant stakeholders of security incidents.
+Added: Applicable data privacy and security obligations may require us, or we may voluntarily choose, to notify relevant stakeholders, including affected individuals, customers, regulators, and investors, of security incidents.
Such disclosures are costly, and the disclosures or the failure to comply with such requirements could lead to adverse consequences.
−Removed: If we (or a third party upon whom we rely) experience a security incident or are perceived to have experienced a security incident, we may experience adverse consequences.
+Added: If we (or a third party with whom we work) experience a security incident or are perceived to have experienced a security incident, we may experience material adverse consequences.
These consequences may include:
7 unchanged sentences
monetary fund diversions;
+Added: diversions of management attention;
interruptions in our operations (including availability of data);
1 unchanged sentence
and other similar harms.
−Removed: Security incidents and attendant consequences may cause interruptions in our operations and could result in a material disruption of our programs.
+Added: Security incidents and attendant material consequences may cause interruptions in our operations and could result in a material disruption of our programs.
For example, the loss of clinical trial data for our product candidates could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.
15 unchanged sentences
Customs regulations, various economic and trade sanctions regulations administered by the U.S.
−Removed: Treasury Department’s Office of Foreign Assets Controls, the U.S.
−Removed: Foreign Corrupt Practices Act of 1977, as amended, or FCPA, the U.S.
+Added: Treasury Department’s Office of Foreign Assets Controls, the FCPA, the U.S.
domestic bribery statute contained in 18 U.S.C.
6 unchanged sentences
Any violations of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm, and other consequences.
+Added: International trade policies, including tariffs, sanctions, and trade barriers may adversely affect our business, financial condition, results of operations, and prospects.
+Added: We operate in a global economy, which includes utilizing third-party suppliers in several countries outside the United States.
+Added: There is inherent risk, based on the complex relationships among the U.S.
+Added: and the countries in which we conduct our business, that political, diplomatic, and national security factors can lead to global trade restrictions and changes in trade policies and export regulations that may adversely affect our business and operations.
+Added: The current international trade and regulatory environment is subject to significant ongoing uncertainty.
+Added: government has recently announced substantial new tariffs affecting a wide range of products and jurisdictions and has indicated an intention to continue developing new trade policies, including with respect to the pharmaceutical industry.
+Added: In response, certain foreign governments have announced or implemented retaliatory tariffs and other protectionist measures.
+Added: These developments have created a dynamic and unpredictable trade landscape, which may adversely impact our business, results of operations, financial condition and prospects.
+Added: We do not own or operate, and currently have no plans to establish, any manufacturing facilities for Viaskin, Viaskin Peanut and other product candidates.
+Added: We currently rely, and expect to continue to rely, on third parties for the manufacture of Viaskin epicutaneous patch, Viaskin Peanut and other product candidates for clinical testing, as well as for manufacture of any products that we may commercialize, if approved.
+Added: Currently, several of our suppliers are located outside of the United States, and the principal suppliers of many of our critical raw materials are located in Europe.
+Added: The API for Viaskin Peanut is manufactured in France.
+Added: We also rely on specialized laboratory equipment, supplies, materials, and precursor compounds, all or part of which we believe may be ultimately sourced from multiple countries outside the United States, to advance our research and development efforts.
+Added: Current or future tariffs will result in increased research and development expenses, including with respect to increased costs associated with APIs, raw materials, laboratory equipment and research materials and components.
+Added: In addition, such tariffs will increase our supply chain complexity and could also potentially disrupt our existing supply chain.
+Added: Trade restrictions affecting the import of materials necessary for clinical trials could result in delays to our
+Added: development timelines.
+Added: Increased development costs and extended development timelines could place us at a competitive disadvantage compared to companies operating in regions with more favorable trade relationships and could reduce investor confidence, negatively impacting our ability to secure additional financing on favorable terms or at all.
+Added: In addition, as we advance toward potential commercialization of Viaskin Peanut, tariffs and trade restrictions could hinder our ability to establish cost-effective production capabilities, negatively impacting our growth prospects.
+Added: Trade disputes, tariffs, restrictions and other political tensions between the United States and other countries may also exacerbate unfavorable macroeconomic conditions including inflationary pressures, foreign exchange volatility, financial market instability, and economic recessions or downturns.
+Added: The ultimate impact of current or future tariffs and trade restrictions remains uncertain and could materially and adversely affect our business, financial condition, and prospects.
+Added: While we actively monitor these risks, any prolonged economic downturn or escalation in trade tensions could materially and adversely affect our business, ability to access the capital markets or other financing sources, results of operations, financial condition and prospects.
We will need to develop and implement sales, marketing and distribution capabilities before we are able to bring any product candidate to market, and as a result, we may encounter difficulties in managing this development and expansion, which could disrupt our operations.
31 unchanged sentences
These and other market and industry factors may cause the market price and demand for our securities to fluctuate substantially, regardless of our actual operating performance, which may limit or prevent investors from readily selling their ADSs or ordinary shares and may otherwise negatively affect the liquidity of our ADSs and ordinary shares.
−Removed: In addition, the stock market in general, and biopharmaceutical companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies.
+Added: In addition, the stock market in general, and
+Added: biopharmaceutical companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies.
Share ownership is concentrated in the hands of our principal shareholders and management, who will continue to be able to exercise a direct or indirect controlling influence on us.
As of December 31, 2025, our executive officers, directors, current 5% or greater shareholders and affiliated entities, including entities affiliated with Baker Bros.
−Removed: Advisors LP, entities affiliated with Braidwell, L.P., entities affiliated with VR Adviser, LLC, and entities affiliated with Bpifrance Participations S.A., together beneficially own approximately 47% of our ordinary shares.
+Added: Advisors LP, entities affiliated with Suvretta Capital Management., entities affiliated with Artisan Partners, L.P., entities affiliated with Invus, entities affiliated with Adage Capital Management L.P., entities affiliated with MPM Capital and entities affiliated with Bpifrance, together beneficially own approximately 49% of our ordinary shares.
As a result, these shareholders, acting together, will have significant influence over all matters that require approval by our shareholders, including the election of directors and approval of significant corporate transactions.
34 unchanged sentences
Investors seeking cash dividends should not purchase the ADSs.
−Removed: Further, under French law, the determination of whether we have been sufficiently profitable to pay dividends is made on the basis of our annual financial statements.
+Added: Further, under
+Added: French law, the determination of whether we have been sufficiently profitable to pay dividends is made on the basis of our annual financial statements.
Therefore, we may be more restricted in our ability to declare dividends than companies not based in France.
3 unchanged sentences
dollar proceeds that holders receive from the sale of the ADSs.
−Removed: Future sales of ordinary shares or ADSs by existing shareholders could depress the market price of the ADSs.
−Removed: As of December 31, 2024, 102,847,501 ordinary shares were issued and outstanding.
−Removed: Sales of a substantial number of shares of our ordinary shares or ADSs in the public market, or the perception that these sales might occur, could depress the market price of our securities and could impair our ability to raise capital through the sale of additional equity securities.
−Removed: A substantial number of our shares are now generally freely tradable, subject, in the case of sales by our affiliates, to the volume limitations and other provisions of Rule 144 under the Securities Act.
−Removed: If holders of these shares sell, or indicate an intent to sell, substantial amounts of our securities in the public market, the trading price of our securities could decline significantly.
−Removed: In June 2022, we completed a $194 million PIPE financing (the “June 2022 PIPE”) from the sale of (i) 32,855,669 Ordinary Shares, nominal value €0.10 per share at a price per Ordinary Share of €3.00 (corresponding to $3.22 on the basis of an exchange rate of $1.0739 = €1.00 published by the European Central Bank on June 8, 2022), and (ii) pre-funded warrants to purchase an aggregate of 28,276,331 Ordinary Shares (the “Warrant Shares”) at a pre-funded price per pre-funded warrant of €2.90 (corresponding to $3.11), which equals the per share price of the Ordinary Shares less the exercise price of €0.10 per pre-funded warrant.
−Removed: Each pre-funded warrant has an exercise price of €0.10 per Warrant Share.
−Removed: Pursuant to a registration rights agreement (the “Registration Rights Agreement”) with the investors, the Company filed a registration statement with the SEC registering the resale of 59,269,629 ordinary shares issued in the June 2022 PIPE, including ordinary shares underlying the pre-funded warrants.
−Removed: The Company also filed a registration statement with the SEC registering the resale of 11,593,170 ordinary shares by Entities affiliated with Baker Bros.
−Removed: Advisors, issued in the June 2022 PIPE, including ordinary shares underlying the pre-funded warrants.
−Removed: As a result, subject to certain beneficial ownership limitations contained in the pre-funded warrants, these shares are freely tradable, without restriction, in the public market.
−Removed: In addition, the exercise of some or all of the pre-funded warrants will increase the number of our outstanding ordinary shares, which may dilute the ownership percentage or voting power of our shareholders.
−Removed: In addition, we have filed a registration statement with the SEC to register the ordinary shares that may be issued under our equity incentive plans.
−Removed: The ordinary shares subject to outstanding options under our equity incentive plans, ordinary shares reserved for future issuance under our equity incentive plans and ordinary shares subject to outstanding warrants will become eligible for sale in the public market in the future, subject to certain legal and contractual limitations.
−Removed: Sales of a large number of the shares issued under these plans in the public market could have an adverse effect on the market price of our securities.
+Added: Future sales of ordinary shares or ADSs by existing shareholders could depress their market price
+Added: We cannot predict whether future issuances or the availability of ordinary shares or ADSs for resale in the open market will decrease their market price.
+Added: We are not restricted from issuing additional securities including any securities that are convertible into or exchangeable for, or that represent the right to receive ordinary shares or ADSs.
+Added: Sales of a substantial number of ordinary shares or ADSs in the public market or the perception that such sales might occur could materially adversely affect their market price.
+Added: Because our decision to issue securities in any future offering will depend on market conditions and other factors beyond our control, we cannot predict or estimate the amount, timing or nature of our future offerings.
+Added: Thus, our stockholders bear the risk of any future stock issuances reducing the market price of our ordinary shares or ADSs and diluting their stock holdings in us.
+Added: The exercise of the warrants detailed within Item 7.
+Added: Forward looking , the exercise of any warrants granted to directors, executive officers and other employees under our stock compensation plans, the issuance of ordinary shares or ADSs in acquisitions and other issuances of ordinary shares or ADSs could have an adverse effect on their market price, and the existence of warrants may materially adversely affect the terms upon which we may be able to obtain additional capital in the future through the sale of equity securities.
The dual listing of our ordinary shares and our ADSs may adversely affect the liquidity and value of the ADSs.
52 unchanged sentences
In addition, if the depositary is unable to sell rights that are not exercised or not distributed or if the sale is not lawful or reasonably practicable, it will allow the rights to lapse, in which case you will receive no value for these rights.
−Removed: According to French law, as of December 31, 2024 we have issued:
−Removed: • 22,266,331 pre-funded warrants at a pre-funded price per pre-funded warrant of €2.90 (corresponding to $3.11), Each pre-funded warrant bears an exercise price of €0.10 per Warrant Share;
−Removed: • Restricted Stock Units (“RSU”), stock options plan (“SO”), and non-employee warrants ( bons de souscription d’actions i.e.
−Removed: “BSA”) representing globally 13,823,961 outstanding shares as of December 31, 2024.
−Removed: The exercise of some or all pre-funded warrants, RSU, SO and non-employee warrants will increase the number of outstanding ordinary shares, which may dilute the ownership percentage or voting power of shareholders by13.4% (without pre-funded warrants exercise, and 35,1% should all pre-funded warrants be exercised).
You may be subject to limitations on the transfer of your ADSs and the withdrawal of the underlying ordinary shares.
4 unchanged sentences
In addition, you may not be able to cancel your ADSs and withdraw the underlying ordinary shares when you owe money for fees, taxes and similar charges and when it is necessary to prohibit withdrawals in order to comply with any laws or governmental regulations that apply to ADSs or to the withdrawal of ordinary shares or other deposited securities.
−Removed: The biotechnology industry has been included in the list of critical technologies subject to foreign investment control procedure in France, which may limit the ability to certain non-French investors to participate in this or any other offering of our securities.
+Added: The biotechnology industry has been included in the list of critical technologies subject to foreign investment control procedure in France, which may limit the ability to certain non-French investors to any offering of our securities.
The completion of any investment (i) by (a) an individual of foreign nationality, (b) any individual of French nationality not domiciled in France within the meaning of article 4B of the French General Tax Code ( Code général des impôt s), (c) any entity governed by foreign law, and (d) any entity governed by French law controlled by one or more of the entities referred to in (a) to (c), (ii) which would result in (a) the acquisition of control—within the meaning of article L.
28 unchanged sentences
securities laws would be considered punitive if it does not seek to compensate the claimant for loss or damage suffered but is intended to punish the defendant.
−Removed: The enforceability of any
−Removed: judgment in France will depend on the particular facts of the case as well as the laws and treaties in effect at the time.
+Added: The enforceability of any judgment in France will depend on the particular facts of the case as well as the laws and treaties in effect at the time.
The United States and France do not currently have a treaty providing for recognition and enforcement of judgments (other than arbitration awards) in civil and commercial matters.
7 unchanged sentences
We are a “smaller reporting company,” and the reduced disclosure requirements applicable to smaller reporting companies may make our ADSs less attractive to investors.
−Removed: We are currently a “smaller reporting company” as defined in the Securities Exchange Act of 1934, as amended, or the Exchange Act.
+Added: We are currently a “smaller reporting company” as defined in the Exchange Act .
We may continue to be a smaller reporting company even after we are no longer an emerging growth company.
We will be a smaller reporting company and may take advantage of the scaled disclosures available to smaller reporting companies for so long as (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.
−Removed: We are permitted and intend to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not smaller reporting companies.
+Added: We are permitted and intend to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not accelerated smaller reporting companies.
These scaled disclosure requirements include, but are not limited to, the following:
−Removed: • not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, or Section 404;
+Added: • not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act;
• reduced disclosure obligations regarding financial information;
5 unchanged sentences
Under the U.S.
−Removed: Internal Revenue Code of 1986, as amended, or the Code, we will be a passive foreign investment company, or PFIC, for any taxable year in which, after the application of certain “look-through” rules with respect to subsidiaries, either (i) 75% or more of our gross income consists of “passive income,” or (ii) 50% or more of the average quarterly value of our assets, including cash, consists of assets that produce, or are held for the production of, “passive income.” Passive income generally includes interest, dividends, rents, certain non-active royalties and capital gains.
+Added: Internal Revenue Code of 1986, as amended (the “Code”), we will be a passive foreign investment company, or PFIC, for any taxable year in which, after the application of certain “look-through” rules with respect to subsidiaries, either (i) 75% or more of our gross income consists of “passive income,” or (ii) 50% or more of the average quarterly value of our assets, including cash, consists of assets that produce, or are held for the production of, “passive income.” Passive income generally includes interest, dividends, rents, certain non-active royalties and capital gains.
Whether we will be a PFIC in any year depends on the composition of our income and the nature and composition of our assets, which we expect may vary substantially over time.
−Removed: Based on the composition of our gross income and the nature and composition of our gross assets, we believe that we may have been a PFIC for the taxable year ending December 31, 2024.
+Added: Based on the composition of our gross income and the nature and composition of our gross assets, we believe that we were not a PFIC for the taxable year ending December 31, 2025.
Because the determination of our PFIC status is based on complicated provisions of the Code and applicable administrative authorities, there can be no assurance that our conclusions concerning our PFIC status for the taxable year ending December 31, 2025 are correct and will not be successfully challenged by applicable tax authorities, and we cannot provide any assurance regarding our PFIC status for the current taxable year or any future taxable year.
3 unchanged sentences
holders, the addition of interest charges to the tax on such gains and certain distributions, and additional reporting requirements.
−Removed: holder in certain circumstances may mitigate the adverse tax consequences of the PFIC rules by filing an election to treat the PFIC “qualified electing fund”, or as a QEF, or, if shares of the PFIC are “marketable stock” for purposes of the PFIC rules, by making a mark-to-market election with respect to the shares of the PFIC.
+Added: holder in certain circumstances may mitigate the adverse tax consequences of the PFIC rules by filing an election to treat the PFIC “qualified electing fund” (“QEF”) or, if shares of the PFIC are “marketable stock” for purposes of the PFIC rules, by making a mark-to-market election with respect to the shares of the PFIC.
For any taxable year in which we are a PFIC, we will determine whether we will provide to U.S.
5 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.