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What changed in DBV Technologies S.A.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of DBV Technologies S.A.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+603 added−618 removedSource: 10-K (2026-03-26) vs 10-K (2025-04-11)

Top changes in DBV Technologies S.A.'s 2025 10-K

603 paragraphs added · 618 removed · 408 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

198 edited+61 added−60 removed290 unchanged
Biggest changeAlternatively, if ED >10 mg and * 100 mg = Median ED at Baseline (month 0); *125 mg = Median dose consumed at accidental consumption of peanut (Deschildre A, et al. Clin Exp Allergy 2015; Peanut-allergic patients in the MIRABEL survey: characteristics, allergists’ dietary advice and lessons from real life. 46:610-620). ‡ Number of subjects with non-missing food challenge endpoint.
Biggest changeClin Exp Allergy 2015; Peanut-allergic patients in the MIRABEL survey: characteristics, allergists’ dietary advice and lessons from real life. 46:610-620). ‡ Number of subjects with non-missing food challenge endpoint. Regarding safety and tolerability findings, no new safety signals were observed, and findings were generally similar to what was reported during the first year of treatment with Viaskin Peanut in EPITOPE.
We are advancing this unique technology to treat children suffering from food allergies for whom safety is paramount since the introduction of the offending allergen into their bloodstream can cause severe or life-threatening allergic reactions, such as anaphylactic shock. We believe Viaskin may offer convenient, , non-invasive immunotherapy to patients.
We are advancing this unique technology to treat children suffering from food allergies for whom safety is paramount since the introduction of the offending allergen into their bloodstream can cause severe or life-threatening allergic reactions, such as anaphylactic shock. We believe Viaskin technology may offer convenient, non-invasive immunotherapy to patients.
With this path forward, the BLA submission for Viaskin Peanut patch in 1 – 3 years-old under the Accelerated Approval program is anticipated to be supported by: i. Positive efficacy and safety data from DBV’s previously completed EPITOPE Phase 3 Study; and ii.
With this path forward, the BLA submission for the Viaskin Peanut patch in 1 – 3 years-old under the Accelerated Approval program is anticipated to be supported by: i. Positive efficacy and safety data from DBV’s previously completed EPITOPE Phase 3 Study; and ii.
The Company announced further that FDA confirmed criteria for a post-marketing confirmatory study in toddlers 1-3 years-old and that the Company and FDA agreed that the confirmatory study will assess the effectiveness of the intended commercial Viaskin Peanut patch and will need to be initiated at the time that the BLA is submitted.
The Company announced further that FDA confirmed criteria for a post-marketing confirmatory study in toddlers 1-3 years-old and that the Company and FDA agreed that the confirmatory study will assess the effectiveness of the intended commercial Viaskin Peanut patch and will need to be initiated at the time that the BLA is submitted.
If we do not sell any of our product candidates covered by the shared patents within 30 months from the date we first market such product candidates, AP-HP may, upon six months’ notice and subject to certain exceptions, convert our exclusive right to the commercial use of the shared patents to a non-exclusive right.
If we do not sell any of our product candidates covered by any of the shared patents within 30 months from the date we first market such product candidates, AP-HP may, upon six months’ notice and subject to certain exceptions, convert our exclusive right to the commercial use of the shared patents to a non-exclusive right.
Absent early termination, the assignment, development and co-ownership agreement will automatically terminate upon the expiration cancellation, or abandonment of the last shared patent. In the event the agreement is terminated, we would no longer have the exclusive right to commercial use of the shared patents, though we would retain our shared ownership rights.
Absent early termination, the assignment, development and co-ownership agreement will automatically terminate upon the expiration, cancellation, or abandonment of the last shared patent. In the event the agreement is terminated early, we would no longer have the exclusive right to commercial use of the shared patents, though we would retain our shared ownership rights.
Moreover, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act; • federal civil and criminal false claims laws, including the federal civil False Claims Act, which impose penalties and provide for civil whistleblower or qui tam actions, and civil monetary penalty laws, which prohibit, among other things, knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent, or making a false statement or record material to payment of a false claim or avoiding, decreasing, or concealing an obligation to pay money to the federal government, including for example, providing inaccurate billing or coding information to customers or promoting a product off-label; • the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created additional federal criminal statutes that prohibit knowingly and willfully executing or attempting to execute a scheme to defraud any healthcare benefit program, knowingly and willfully falsifying, concealing or covering up a material fact or making false statements relating to healthcare matters, knowingly and willfully embezzling or stealing from a healthcare benefit program, or willfully obstructing a criminal investigation of a healthcare offense.
Moreover, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act; • federal civil and criminal false claims laws, including the federal civil False Claims Act, which impose penalties and provide for civil whistleblower or qui tam actions, and civil monetary penalty laws, which prohibit, among other things, knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent, or making a false statement or record material to payment of a false claim or avoiding, decreasing, or concealing an obligation to pay money to the federal government, including for example, providing inaccurate billing or coding information to customers or promoting a product off-label; • the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created additional federal criminal statutes that prohibit knowingly and willfully executing or attempting to execute a scheme to defraud any healthcare benefit program, knowingly and willfully falsifying, concealing or covering up a material fact or making false statements relating to healthcare matters, knowingly and willfully embezzling or stealing from a healthcare benefit program, or willfully obstructing a criminal investigation of a healthcare offense.
On April 19, 2023, the Company outlined the regulatory pathway for Viaskin Peanut in children 1-3 years old after the FDA confirmed in written responses to the Company’s Pre-BLA meeting request that the Company’s EPITOPE phase 3 study met the pre-specified criteria for success for the primary endpoint and did not request any additional efficacy study in this age group.
On April 19, 2023, the Company outlined the regulatory pathway for Viaskin Peanut patch in children 1-3 years old after the FDA confirmed in written responses to the Company’s Pre-BLA meeting request that the Company’s EPITOPE phase 3 study met the pre-specified criteria for success for the primary endpoint and did not request any additional efficacy study in this age group.
Upon commercialization of any product covered by the shared patents, which we expect would include our Viaskin product candidates, we will be obligated to pay AP-HP and Université Paris Cité a percentage of net sales as a royalty. This royalty is in the low single digits and varies depending on the particular patent used in the product.
Upon commercialization of any product covered by the shared patents, which we expect would include our Viaskin product candidates, we will be obligated to pay AP-HP and Université Paris Cité a percentage of net sales as a royalty. This royalty is in the low single digits and varies depending on the particular patent.
The containment of healthcare costs has become a priority of federal and state governments, and the prices of drugs have been a focus in this effort. The U.S. government, state legislatures and foreign governments have shown significant interest in implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements for substitution of generic products.
The containment of healthcare costs has become a priority of federal and state governments, and the prices of drugs have been a focus in this effort. The U.S. government, state legislatures and foreign governments have shown significant interest in implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements for substitution of generic products. For example, the U.S.
Key elements of our strategy are: • pursue the continued development of Viaskin Peanut for toddlers and children with peanut allergy; • seek regulatory approval for Viaskin Peanut in the United States and the European Union; • advance the clinical development of additional Viaskin product candidates in the United States and other major markets; • build a broad immunotherapy product pipeline with our innovative Viaskin technology platform.
Key elements of our strategy are: • pursue the continued development of Viaskin ® Peanut Patch for toddlers and children with peanut allergy; • seek regulatory approval for Viaskin ® Peanut Patch in the United States and the European Union; • advance the clinical development of additional Viaskin ® product candidates in the United States and other major markets; • build a broad immunotherapy product pipeline with our innovative Viaskin ® technology platform.
The EMA recently confirmed through scientific advice that the completed EPITOPE study in 1 – 3 years-old, and a positive VITESSE study in 4 – 7 years-old, could constitute an MAA submission for a 1 – 7 years-old indication for peanut allergy patients using the modified patch, along with a new safety study in toddlers ages 1 – 3 years-old with the modified patch.
The EMA recently confirmed through scientific advice that the completed EPITOPE study in 1 – 3 years-old, and a positive VITESSE study in 4 – 7 years-old, could constitute an MAA submission for a 1 – 7 years-old indication for peanut allergy patients using the modified patch, along with a new safety study in toddlers ages 1 – 3 years-old also with the modified patch.
In the future, we may apply for extension of patent term for our currently owned or licensed patents to add patent term beyond its then-current expiration date, depending on the expected length of the clinical trials and other factors involved in the filing of the relevant BLA.
In the future, we may apply for extension of patent term for our owned or licensed patents to add patent term beyond its then-current expiration date, depending on the expected length of the clinical trials and other factors involved in the filing of the relevant BLA.
There remains an unmet need for additional therapies for patients with peanut allergy. In most other therapeutic areas, healthcare providers, patients and their families have several treatment options, and they are able to choose the treatment that best fits their needs.
There remains an unmet need for additional therapies for patients with a peanut allergy. In most other therapeutic areas, healthcare providers, patients, and their families have several treatment options, and they are able to choose the treatment that best fits their needs.
Under the centralized procedure, the EMA’s Committee for Medicinal Products for Human Use, or CHMP, conducts the initial assessment of a product. The CHMP is also responsible for several post-authorization and maintenance activities, such as the assessment of modifications or extensions to an existing MA.
Under the centralized procedure, the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) conducts the initial assessment of a product. The CHMP is also responsible for several post-authorization and maintenance activities, such as the assessment of modifications or extensions to an existing MA.
On October 22, 2024, the Company announced it received scientific advice from EMA on an indication for ages 1 – 7 years-old in Europe. The Company sought scientific advice from EMA regarding the components of a MAA for the Viaskin Peanut patch.
On October 22, 2024, the Company announced it received scientific advice from EMA on an indication for ages 1 – 7 years-old in Europe regarding the components of a MAA for the Viaskin Peanut patch.
Interim Results from Open-label Extension to EPITOPE Study (EPOPEX) Following the 12-month treatment period of EPITOPE, eligible subjects could opt to enroll in the open-label, extension (“OLE”) study for up to three years of active total treatment.
Results from Open-label Extension to EPITOPE Study (EPOPEX) Following the 12-month treatment period of EPITOPE, eligible subjects could opt to enroll in the open-label, extension (“OLE”) study for up to three years of active total treatment.
The Company expects that the confirmatory study will be initiated by the time of BLA submission and would run in parallel to commercialization in the United States, if Viaskin Peanut is approved.
The Company expects that the confirmatory study will be initiated by the time of BLA submission and would run in parallel to commercialization in the United States, if the Viaskin Peanut patch is approved.
The Company expects that the confirmatory study will be initiated by the time of BLA submission and would run in parallel to commercialization in the United States, if Viaskin Peanut is approved.
The Company expects that the confirmatory study will be initiated by the time of BLA submission and would run in parallel to commercialization in the United States, if the Viaskin Peanut patch is approved.
This does not include a supplement for the biological product or a subsequent application by the same sponsor or manufacturer of the biological product (or licensor, predecessor in interest, or other related entity) for a change that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength, unless that change is a modification to the structure of the biological product and such modification changes its safety, purity, or potency.
This does not include a supplement for the biological product or a subsequent application by the same sponsor or manufacturer of the biological product (or licensor, predecessor in interest, or other related entity) for a change that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength, unless that change is a modification to the structure of the biological product and such modification F - 21 changes its safety, purity, or potency.
According to a 2020 publication, a recent survey conducted across eight European countries reported high rates of frustration, stress and isolation in peanut-allergic individuals and their caregivers.
According to a 2020 publication, a survey conducted across eight European countries reported high rates of frustration, stress and isolation in peanut-allergic individuals and their caregivers.
FDASIA requires that a sponsor who is planning to submit a marketing application for a drug or biological product that includes a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration submit an initial Pediatric Study Plan, or PSP, within sixty days of an end-of-Phase 2 meeting or as may be agreed between the sponsor and FDA.
FDASIA requires that a sponsor who is planning to submit a marketing application for a drug or biological product that includes a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration submit an initial Pediatric Study Plan (“PSP”) within sixty days of an end-of-Phase 2 meeting or as may be agreed between the sponsor and FDA.
Response Rate (ITT) after 12 months With respect to CRD, a key secondary endpoint which measures threshold reactivity during the DBPCFC, we observed that at month 12, patients treated with Viaskin Peanut 250 μg or placebo reached a mean CRD of 906 mg (median 444 mg) and 361 mg (median 144 mg) of peanut protein, respectively.
F - 13 Response Rate (ITT) after 12 months With respect to CRD, a key secondary endpoint which measures threshold reactivity during the DBPCFC, we observed that at month 12, patients treated with Viaskin Peanut 250 μg or placebo reached a mean CRD of 906 mg (median 444 mg) and 361 mg (median 144 mg) of peanut protein, respectively.
Written IND safety reports must be submitted to the FDA and the investigators for serious and unexpected suspected adverse, findings from other studies suggesting a significant risk to humans exposed to the drug, findings from animal or in vitro testing suggesting a significant risk to humans, and any clinically important rate increase of a serious suspected adverse reaction over that listed in the protocol or investigator brochure.
Written IND safety reports must be submitted to the FDA and the investigators for serious and unexpected suspected adverse, findings from other studies suggesting a significant risk to humans exposed to the drug, findings from animal or in vitro testing suggesting a significant risk to humans, and any clinically important rate increase of a serious suspected F - 24 adverse reaction over that listed in the protocol or investigator brochure.
Once the MA is obtained in all EU Member States and study results are included in the product information, even when negative, the product is eligible for a six-month extension to the Supplementary Protection Certificate, or SPC, if any is in effect at the time of authorization or, in the case of orphan medicinal products, a two-year extension of orphan market exclusivity.
Once the MA is obtained in all EU Member States and study results are included in the product information, even when negative, the product is eligible for a six-month extension to the Supplementary Protection Certificate (“SPC”) if any is in effect at the time of authorization or, in the case of orphan medicinal products, a two-year extension of orphan market exclusivity.
We defined initiation as the submission of the trial protocol to selected study sites for subsequent Institutional Review Board (IRB) approval and Ethics Committee (EC) opinion. On September 21, 2022, the Company announced it received from the FDA a partial clinical hold letter related to certain design elements of VITESSE.
We defined initiation as the submission of the trial protocol to selected study sites for subsequent Institutional Review Board (“IRB”) approval and Ethics Committee (EC) opinion. On September 21, 2022, the Company announced it received from the FDA a partial clinical hold letter related to certain design elements of VITESSE.
Our therapeutic approach is based on epicutaneous immunotherapy, or EPIT, our proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin, an epicutaneous patch (i.e., a skin patch). We have generated significant data demonstrating that Viaskin’s mechanism of action is novel and differentiated.
Our therapeutic approach is based on epicutaneous immunotherapy, or EPIT, our proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin, an epicutaneous patch (i.e., a skin patch). We have generated significant data demonstrating that Viaskin patch’s mechanism of action is novel and differentiated.
Alternatively, if ED >10 mg and The EPITOPE safety results were generally consistent with the safety profile of Viaskin Peanut 250 μg observed in children with peanut allergy ages 4 years and older in prior clinical trials. No imbalance in the overall adverse event (AE) rate was observed in the trial between the active and placebo arms.
Alternatively, if ED >10 mg and The EPITOPE safety results were generally consistent with the safety profile of Viaskin Peanut 250 μg observed in children with peanut allergy ages 4 years and older in prior clinical trials. No imbalance in the overall adverse event (“AE”) rate was observed in the trial between the active and placebo arms.
Indeed, in France, the manufacturer’s price excluding tax of medicines reimbursable to insured persons (registered on the Social Security List) is the subject of a multi-year agreement negotiated between each pharmaceutical company and the Economic Committee for Health Products, or CEPS (failing this, by unilateral decision of the CEPS).
Indeed, in France, the manufacturer’s price excluding tax of medicines reimbursable to insured persons (registered on the Social Security List) is the subject of a multi-year agreement negotiated between each pharmaceutical company and the Economic Committee for Health Products (“CEPS”) (failing this, by unilateral decision of the CEPS).
However, since peanut is a common ingredient in many foods, complete avoidance is difficult to achieve, and accidental exposures in peanut-allergic children remains a common issue. The estimated rate of accidental peanut exposure in peanut-allergic children is estimated to be 12.4% per year, with approximately 40% of children experiencing an accidental exposure within three years of diagnosis.
However, since peanut is a common ingredient in many foods, complete avoidance is difficult to achieve, and accidental exposures in peanut-allergic children remains a common issue. The estimated rate of accidental peanut exposure in peanut-allergic children is estimated to be 12.4% per year, with F - 6 approximately 40% of children experiencing an accidental exposure within three years of diagnosis.
There is one treatment for peanut allergy in children 1 to 17 years of age approved by the FDA and the European Commission: Palforzia, a formulation of peanut flour developed by Aimmune Therapeutics, Inc., or Aimmune. Nestlé S.A. acquired Aimmune in October 2020 and divested the Palforzia business to Stallergenes Greer in September 2023.
There is one treatment for peanut allergy in children 1 to 17 years of age approved by the FDA and the European Commission: Palforzia, a formulation of peanut flour developed by Aimmune Therapeutics, Inc. (“Aimmune”). Nestlé S.A. acquired Aimmune in October 2020 and divested the Palforzia business to Stallergenes Greer in September 2023.
The FDA may also place other conditions on approvals including the requirement for a Risk Evaluation and Mitigation Strategy, or REMS, to assure the safe use of the product. If the FDA concludes a REMS is needed, the sponsor of the BLA must submit a proposed REMS. The FDA will not approve the BLA without an approved REMS, if required.
The FDA may also place other conditions on approvals including the requirement for a Risk Evaluation and Mitigation Strategy (“REMS”) to assure the safe use of the product. If the FDA concludes a REMS is needed, the sponsor of the BLA must submit a proposed REMS. The FDA will not approve the BLA without an approved REMS, if required.
On May 10, 2023, the New England Journal of Medicine (“NEJM”) published results from the EPITOPE phase 3 clinical study that demonstrated EPIT with Viaskin Peanut was statistically superior to placebo in desensitizing children to peanut exposure by increasing the peanut dose that triggers allergic symptoms.
F - 9 On May 10, 2023, the New England Journal of Medicine (“NEJM”) published results from the EPITOPE phase 3 clinical study that demonstrated EPIT with Viaskin Peanut was statistically superior to placebo in desensitizing children to peanut exposure by increasing the peanut dose that triggers allergic symptoms.
In November 2014, we initiated a multi-center, double-blind, placebo-controlled, randomized Phase 1/2 dose-finding trial to study the safety and efficacy of Viaskin Milk in 198 subjects with Immunoglobulin E, or IgE, mediated CMPA, which we refer to as the Milk Efficacy and Safety, or MILES, trial.
In November 2014, we initiated a multi-center, double-blind, placebo-controlled, randomized Phase 1/2 dose-finding trial to study the safety and efficacy of Viaskin Milk in 198 subjects with Immunoglobulin E, or IgE, mediated CMPA, which we refer to as the Milk Efficacy and Safety (“MILES”).
In the EU, there is a special regime for biosimilars, or biological medicinal products that are similar to a reference medicinal product but that do not meet the definition of a generic medicinal product. For such products, the results of appropriate preclinical or clinical trials must be provided in support of an application for MA.
F - 29 In the EU, there is a special regime for biosimilars, or biological medicinal products that are similar to a reference medicinal product but that do not meet the definition of a generic medicinal product. For such products, the results of appropriate preclinical or clinical trials must be provided in support of an application for MA.
All new MAAs must include a risk management plan, or RMP, describing the risk management system that the company will put in place and documenting measures to prevent or minimize the risks associated with the product. The regulatory authorities may also impose specific obligations as a condition of the MA.
All new MAAs must include a risk management plan (“RMP”) describing the risk management system that the company will put in place and documenting measures to prevent or minimize the risks associated with the product. The regulatory authorities may also impose specific obligations as a condition of the MA.
These patents and applications generally fall into five broad categories: • two U.S. patents, which we co-own with with Assistance Publique-Hôpitaux de Paris, or AP-HP, and Université Paris Cité (formerly Université de Paris-Descartes,and prior to that, Université de Paris, prior to merger and name change), relating to the Viaskin electrostatic patch and its use, which expired in 2022; • patents and patent applications which we own relating to our electrospray method of manufacturing the Viaskin electrostatic patch, which may expire as early as 2029; • patents and patent applications we co-own with AP-HP, and the Université Paris Cité relating to the treatment of peanut, milk, egg, and other allergies using our Viaskin patch technology, which may expire as early as 2028; • design patents and patent applications, which we own relating to various designs of components of the Viaskin patch, which may expire as early as 2032; and • a variety of other patent applications that we own or co-own relating, for example, to prophylactic uses of the Viaskin patch technology and to treatment of other indications using the Viaskin patch technology, and to other technologies.
These patents and applications generally fall into five broad categories: • two U.S. patents, which we co-own with Assistance Publique-Hôpitaux de Paris (“AP-HP”) and Université Paris Cité (formerly Université de Paris-Descartes,and prior to that, Université de Paris, prior to merger and name change), relating to the Viaskin electrostatic patch and its use, which expired in 2022; • patents and patent applications which we own relating to our electrospray method of manufacturing the Viaskin electrostatic patch, which may expire as late as 2029; • patents and patent applications we co-own with AP-HP, and the Université Paris Cité relating to the treatment of peanut, milk, egg, and other allergies using our Viaskin patch technology, which may expire as early as 2028; • design patents and patent applications, which we own relating to various designs of components of the Viaskin patch, which may expire as early as 2032; and • a variety of other patent applications that we own or co-own relating, for example, to uses of the Viaskin patch technology and to treatment of other indications using the Viaskin patch technology, and to other technologies.
On December 11, 2024, the Company announced that it reached alignment with FDA on the Accelerated Approval pathway for Viaskin Peanut patch in toddlers 1-3 years-old and on key study design elements for the COMFORT Toddlers study, including study size and wear time collection methodology and analysis.
F - 17 On December 11, 2024, the Company announced that it reached alignment with FDA on the Accelerated Approval pathway for Viaskin Peanut patch in toddlers 1-3 years-old and on key study design elements for the COMFORT Toddlers study, including study size and wear time collection methodology and analysis.
Overall, 21 subjects (8.6%) in the Viaskin Peanut arm and three subjects (2.5%) in the placebo arm experienced a serious adverse event (SAE). Only one of the SAEs (0.4%), which was mild periorbital edema (swelling around the eye) in the Viaskin Peanut arm, was deemed related to treatment.
Overall, 21 subjects (8.6%) in the Viaskin Peanut arm and three subjects (2.5%) in the placebo arm experienced a serious adverse event (“SAE”). Only one of the SAEs (0.4%), which was mild periorbital edema (swelling around the eye) in the Viaskin Peanut arm, was deemed related to treatment.
Manufacturing and Supply Our Proprietary Viaskin Technology We have engineered a proprietary manufacturing technology for Viaskin patch, which is designed to comply with the most stringent pharmaceutical production standards, including those promulgated by the FDA, in order to enable Viaskin to deliver proteins via intact skin.
F - 19 Manufacturing and Supply Our Proprietary Viaskin Technology We have engineered a proprietary manufacturing technology for Viaskin patch, which is designed to comply with the most stringent pharmaceutical production standards, including those promulgated by the FDA, in order to enable Viaskin to deliver proteins via intact skin.
Results of REALISE Trial Results from the six-month blinded portion of this trial were comparable with outcomes from previous trials of Viaskin Peanut 250 μg. The most commonly reported adverse events were local application site reactions, which were mostly mild and moderate in nature.
Results of REALISE Trial F - 16 Results from the six-month blinded portion of this trial were comparable with outcomes from previous trials of Viaskin Peanut 250 μg. The most commonly reported adverse events were local application site reactions, which were mostly mild and moderate in nature.
We have also entered into a Commercial Supply Agreement, dated January 13, 2020, as amended (the “Commercial Supply Agreement”), with FAREVA setting forth the terms and conditions for the manufacture and supply of commercial batches of Viaskin Peanut by FAREVA. We previously agreed with FAREVA to delay implementation of the Commercial Supply Agreement.
Potential Commercialization We have also entered into a Commercial Supply Agreement, dated January 13, 2020, as amended (the “Commercial Supply Agreement”), with FAREVA setting forth the terms and conditions for the manufacture and supply of commercial batches of Viaskin Peanut by FAREVA. We previously agreed with FAREVA to delay implementation of the Commercial Supply Agreement.
Generally, before a new drug or biologic can be marketed, considerable data demonstrating its quality, safety and efficacy must be obtained, organized into a format specific to each regulatory authority, submitted for review and approved by the regulatory authority. U.S.
Generally, before a new drug or biologic can be marketed, considerable data demonstrating its quality, safety and efficacy must be obtained, organized into a format specific to each regulatory authority, submitted for review and approved by the regulatory authority. F - 23 U.S.
The process required by the FDA before a biologic may be marketed in the United States generally involves the following: • completion of extensive nonclinical, sometimes referred to as pre-clinical laboratory tests, pre-clinical animal studies and formulation studies in accordance with applicable regulations, including the FDA’s Good Laboratory Practice, or GLP, regulations; • submission to the FDA of an IND, which must become effective before human clinical trials may begin; • performance of adequate and well-controlled human clinical trials in accordance with applicable IND and other clinical trial-related regulations, sometimes referred to as good clinical practices, or GCPs, to establish the safety and efficacy of the proposed product candidate for its proposed indication; • submission to the FDA of a BLA; • satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities where the product is produced to assess compliance with the FDA’s current good manufacturing practice, or cGMP, requirements to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality, purity and potency; • potential FDA audit of the pre-clinical and/or clinical trial sites that generated the data in support of the BLA; and • FDA review and approval of the BLA prior to any commercial marketing or sale of the product in the United States.
The process required by the FDA before a biologic may be marketed in the United States generally involves the following: • completion of extensive nonclinical, sometimes referred to as pre-clinical laboratory tests, pre-clinical animal studies and formulation studies in accordance with applicable regulations, including the FDA’s Good Laboratory Practice (“GLP”) regulations; • submission to the FDA of an IND, which must become effective before human clinical trials may begin; • performance of adequate and well-controlled human clinical trials in accordance with applicable IND and other clinical trial-related regulations, sometimes referred to as good clinical practices (“GCPs”) to establish the safety and efficacy of the proposed product candidate for its proposed indication; • submission to the FDA of a BLA; • satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities where the product is produced to assess compliance with the FDA’s current good manufacturing practice (“cGMP”) requirements to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality, purity and potency; • potential FDA audit of the pre-clinical and/or clinical trial sites that generated the data in support of the BLA; and • FDA review and approval of the BLA prior to any commercial marketing or sale of the product in the United States.
After three years of VP250, 83.5% of participants reached an eliciting dose (ED) of ≥1000 mg, an increase from 64.2% at month 12 (the EPITOPE study). A similar increase was observed for participants reaching an ED of ≥2000 mg (72.7% at month 36; 37.0% at month 12;).
After three years of VP250, 83.5% of participants reached an ED of ≥1000 mg, an increase from 64.2% at month 12 (the EPITOPE study). A similar increase was observed for participants reaching an ED of ≥2000 mg (72.7% at month 36; 37.0% at month 12).
VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy) On September 7, 2022, we announced the initiation of VITESSE, a new Phase 3 pivotal study of the modified Viaskin Peanut (mVP) patch in children ages 4-7 years with peanut allergy.
VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy) On September 7, 2022, we announced the initiation of VITESSE, a new Phase 3 pivotal study of the modified Viaskin Peanut (“mVP”) patch in children ages 4-7 years with peanut allergy.
Fast track designation, priority review and accelerated approval do not change the standards for approval but may expedite the development or approval process. Breakthrough Therapy Designation The Food and Drug Administration Safety and Innovation Act, or FDASIA, amended the FDCA to require the FDA to expedite the development and review of a breakthrough therapy.
Fast track designation, priority review and accelerated approval do not change the standards for approval but may expedite the development or approval process. Breakthrough Therapy Designation The Food and Drug Administration Safety and Innovation Act (“FDASIA”), amended the FDCA to require the FDA to expedite the development and review of a breakthrough therapy.
European Union Drug Review and Approval In the European Economic Area, or EEA, which is comprised of the 27 Member States of the EU plus Norway, Iceland and Liechtenstein, medicinal products can only be commercialized after obtaining a Marketing Authorization, or MA.
European Union Drug Review and Approval In the European Economic Area, or EEA, which is comprised of the 27 Member States of the EU plus Norway, Iceland and Liechtenstein, medicinal products can only be commercialized after obtaining a Marketing Authorization (“MA”).
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; • the federal Physician Payments Sunshine Act, enacted as part of the ACA, which requires 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 information regarding certain ownership and investment interests held by physicians or their immediate family members; • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations, which imposes certain requirements on covered entities and their business associates, and their covered subcontractors, relating to the privacy, security and transmission of individually identifiable health information; and • state, local and foreign law equivalents of each of the above federal laws, 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; 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 by pharmaceutical sales representatives; state 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, thus complicating compliance efforts.
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; • the federal Physician Payments Sunshine Act, enacted as part of the ACA, which requires 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 information regarding certain ownership and investment interests held by physicians or their immediate family members; • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH” and its implementing regulations, which imposes certain requirements on covered entities and their business associates, and their covered subcontractors, relating to the privacy, security and transmission of individually identifiable health information; and • state, local and foreign law equivalents of each of the above federal laws, 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; 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 by pharmaceutical sales representatives; 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, thus complicating compliance efforts.
Decreases in third-party reimbursement for our product candidate or a decision by a third-party payor to not cover our product candidate could reduce physician usage of the product candidate and have a material adverse effect on our sales, results of operations and financial condition.
Decreases in third-party F - 31 reimbursement for our product candidate or a decision by a third-party payor to not cover our product candidate could reduce physician usage of the product candidate and have a material adverse effect on our sales, results of operations and financial condition.
Other Healthcare Laws and Compliance Requirements Our business operations in the United States and our arrangements with clinical investigators, healthcare providers, consultants, third-party payors and patients may expose us to broadly applicable federal, state, and foreign fraud and abuse and other healthcare laws.
F - 32 Other Healthcare Laws and Compliance Requirements Our business operations in the United States and our arrangements with clinical investigators, healthcare providers, consultants, third-party payors and patients may expose us to broadly applicable federal, state, and foreign fraud and abuse and other healthcare laws.
Viaskin Peanut for Children ages 4-7 We are evaluating the modified (circular) Viaskin Peanut patch in children ages 4-7 years with peanut allergy in two Phase 3 clinical trials with the intent for the trials to support a future BLA submission in this age group.
F - 11 Viaskin Peanut for Children ages 4-7 We are evaluating the modified (circular) Viaskin Peanut patch in children ages 4-7 years with peanut allergy in two Phase 3 clinical trials with the intent for the trials to support a future BLA submission in this age group.
Other Regulatory Matters Manufacturing, sales, promotion and other activities following product approval are also subject to regulation by numerous regulatory authorities in addition to the FDA, including the Centers for Medicare & Medicaid Services, or CMS, other divisions of the Department of Health and Human Services, the Drug Enforcement Administration, the Consumer Product Safety Commission, the Federal Trade Commission, the Occupational Safety & Health Administration, the Environmental Protection Agency and state and local governments.
Other Regulatory Matters Manufacturing, sales, promotion and other activities following product approval are also subject to regulation by numerous regulatory authorities in addition to the FDA, including the Centers for Medicare & Medicaid Services (“CMS”) other divisions of the Department of Health and Human Services, the Drug Enforcement Administration, the Consumer Product Safety Commission, the Federal Trade Commission, the Occupational Safety & Health Administration, the Environmental Protection Agency and state and local governments.
In post-PCH discussions, we agreed with the FDA that a statistical test of adhesion will be included in the VITESSE statistical analysis plan and further considered patch adhesion data collection and interpretation in the context of the novel nature of the Viaskin patch platform.
In post-PCH discussions, we agreed with the FDA that a statistical test of adhesion would be included in the VITESSE statistical analysis plan and further considered patch adhesion data collection and interpretation in the context of the novel nature of the Viaskin patch platform.
Indeed, based on quantitative risk analysis, or QRA, modeling from Baumert et al using national databases of consumption and contamination amounts, this improvement in ED from ≤100 mg to ≥300 mg is predicted to reduce the risk of an allergic reaction due to accidental peanut exposure through a group of common contaminated packaged foods by over 95%.
Indeed, based on quantitative risk analysis (“QRA”) modeling from Baumert et al using national databases of consumption and contamination amounts, this improvement in ED from ≤100 mg to ≥300 mg is predicted to reduce the risk of an allergic reaction due to accidental peanut exposure through a group of common contaminated packaged foods by over 95%.
This compares to 67% of subjects after one year of therapy. 81.3% of Viaskin Peanut subjects reached an eliciting dose (ED) of ≥1000 mg (equivalent to approximately three peanuts; central chart), relative to 64% after one-year of treatment observed in EPITOPE.
This compares to 67% of subjects after one year of therapy. 81.3% of Viaskin Peanut subjects reached an ED of ≥1000 mg (equivalent to approximately three peanuts; central chart), relative to 64% after one-year of treatment observed in EPITOPE.
Under the Prescription Drug User Fee Act, or PDUFA, as amended, each BLA must be accompanied by a significant user fee, which is adjusted on an annual basis. PDUFA also imposes an annual program fee for approved drugs.
Under the Prescription Drug User Fee Act, as amended (“PDUFA”), each BLA must be accompanied by a significant user fee, which is adjusted on an annual basis. PDUFA also imposes an annual program fee for approved drugs.
An abbreviated approval pathway for biological products shown to be similar to, or interchangeable with, an FDA-licensed reference biological product was created by the Biologics Price Competition and Innovation Act of 2009, or BPCIA.
An abbreviated approval pathway for biological products shown to be similar to, or interchangeable with, an FDA-licensed reference biological product was created by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”).
A reference biological product is granted twelve years of exclusivity from the time of first licensure of the product, and the FDA will not accept an application for a biosimilar or interchangeable product based on the reference biological product until four years after the date of first licensure.
A reference biological product is granted twelve years of exclusivity from the time of first licensure of the product, and the FDA will not accept an application for a biosimilar product based on the reference biological product until four years after the date of first licensure.
Following analyses of the data, the 300 μg dose of Viaskin Milk was identified as the dose with the greatest observed clinical activity for children (intent-to-treat, or ITT, p=0.042). We believe these results support further advancement of the Viaskin Milk program, and we intend to discuss findings with regulatory authorities to determine the design of future clinical trial.
Following analyses of the data, the 300 μg dose of Viaskin Milk was identified as the dose with the greatest observed clinical activity for children (intent-to-treat (“ITT”) p=0.042). We believe these results support further advancement of the Viaskin Milk program, and we intend to discuss findings with regulatory authorities to determine the design of future clinical trial.
Innovative products that target an unmet medical need and are expected to be of major public health interest may be eligible for a number of expedited development and review programs, such as the Priority Medicines, or PRIME, scheme, which provides incentives similar to the breakthrough therapy designation in the U.S.
Innovative products that target an unmet medical need and are expected to be of major public health interest may be eligible for a number of expedited development and review programs, such as the Priority Medicines (“PRIME”) scheme, which provides incentives similar to the breakthrough therapy designation in the U.S.
EPIT is an emerging therapeutic approach to food allergy that utilizes the unique immune properties of the skin to deliver allergen directly to antigen-presenting cells in the epidermis and dermis to initiate desensitization.
EPIT is an emerging therapeutic approach to food allergy that utilizes the unique immune properties of the skin to deliver allergen directly to antigen-presenting cells in the epidermis and dermis to induce desensitization.
In November 2023, we announced the interim analyses from the first year of the open-label extension of EPITOPE. These data were presented at the annual American College of Allergy, Asthma, and Immunology (ACAAI) in November 2023.
In November 2023, we announced the interim analyses from the first year of the open-label extension of EPITOPE. These data were presented at the annual American College of Allergy, Asthma, and Immunology (“ACAAI”) in November 2023.
Secondary endpoints included the change from baseline of mean and median cumulative reactive dose of peanut protein, or CRD, which is used to establish the total quantity of peanut protein consumed during the DBPCFC. Serological markers were also measured at baseline, three, six and 12 months to characterize the immunological changes observed in patients.
Secondary endpoints included the change from baseline of mean and median cumulative reactive dose (“CRD”) of peanut protein which is used to establish the total quantity of peanut protein consumed during the DBPCFC. Serological markers were also measured at baseline, three, six and 12 months to characterize the immunological changes observed in patients.
In the EU, the advertising and promotion of medicinal products are subject to both EU and EU Member States’ laws governing promotion of medicinal products, interactions with physicians and other healthcare professionals, misleading and comparative advertising and unfair commercial practices.
Other EU Compliance Requirements In the EU, the advertising and promotion of medicinal products are subject to both EU and EU Member States’ laws governing promotion of medicinal products, interactions with physicians and other healthcare professionals, misleading and comparative advertising and unfair commercial practices.
The results demonstrated long-term clinical benefit as shown by an increase in eliciting dose, or ED, which may decrease the chance of reacting to an accidental peanut exposure. Results of the PEOPLE trial for participants receiving three years of active treatment were published in the Journal of Allergy and Clinical Immunology in October 2020.
The results demonstrated long-term clinical benefit as shown by an increase in ED which may decrease the chance of reacting to an accidental peanut exposure. Results of the PEOPLE trial for participants receiving three years of active treatment were published in the Journal of Allergy and Clinical Immunology in October 2020.
The information found on our website is not incorporated by reference into this Annual Report on Form 10-K or any other report we file with or furnish to the SEC.
The information found on our website is not incorporated by reference into this Annual Report on Form 10-K or any other report we file with or furnish to the SEC. F - 34
PEOPLE (PEPITES Open Label Extension Study) The PEOPLE trial, which was completed in October 2022, is an open-label extension study that evaluated the long-term safety, tolerability and efficacy of Viaskin Peanut 250 μg in patients who have completed the Phase 3 PEPITES trial. The last patient visit of the PEOPLE trial occurred on October 12, 2022.
PEOPLE (PEPITES Open Label Extension Study) F - 15 The PEOPLE trial, which was completed in October 2022, is an OLE study that evaluated the long-term safety, tolerability and efficacy of Viaskin Peanut 250 μg in patients who have completed the Phase 3 PEPITES trial. The last patient visit of the PEOPLE trial occurred on October 12, 2022.
Moreover, the constituent parts of a combination product retain their regulatory status, for example, as a biologic or device, and as such, we may be subject to additional requirements in the Quality System Regulation, or QSR, applicable to medical devices, such as design controls, purchasing controls, and corrective and preventive action.
Moreover, the constituent parts of a combination product retain their regulatory status, for example, as a biologic or device, and as such, we may be subject to additional requirements in the Quality Management System Regulation (“QMSR”) applicable to medical devices, such as design controls, purchasing controls, and corrective and preventive action.
Item 1. Business. Overview DBV Technologies is a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin.
Item 1. Business. Overview DBV Technologies is a late-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin.
A treatment responder is defined as either a subject with a baseline eliciting dose (ED) ≤30 mg who reaches an ED ≥300 mg of peanut protein at month 12, or a subject with a baseline ED = 100 mg who reaches an ED ≥600 mg of peanut protein at month 12.
A treatment responder is defined as either a subject with a baseline ED ≤30 mg who reaches an ED ≥300 mg of peanut protein at month 12, or a subject with a baseline ED = 100 mg who reaches an ED ≥600 mg of peanut protein at month 12.
We make available on our website, free of charge, our Annual Reports on Form 10-K, our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K and any amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, or the Exchange Act, as soon as reasonably practicable after we electronically file such material with, or furnish it to, the Securities and Exchange Commission, or the SEC.
We make available on our website, free of charge, our Annual Reports on Form 10-K, our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K and any amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended (“the Exchange Act”) as soon as reasonably practicable after we electronically file such material with, or furnish it to, the Securities and Exchange Commission (“the SEC”).
Biosimilarity, which requires that the biological product be highly similar to the reference product notwithstanding minor differences in clinically inactive components and that there be no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency, which can be shown through analytical studies, animal studies, and a clinical trial or trials.
Biosimilarity requires that the biological product be highly similar to the reference product notwithstanding minor differences in clinically inactive components and that there be no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency, which can be shown through analytical studies, animal studies, and a clinical study or studies.
In January 2020, we announced positive topline results up to Year 3 from the open-label extension of our Phase 3 PEPITES trial, or PEOPLE trial, evaluating the long-term efficacy and safety of investigational Viaskin Peanut in peanut-allergic children ages four to 11 years.
In January 2020, we announced positive topline results up to Year 3 from the open-label extension of our Phase 3 PEPITES trial (“PEOPLE”) evaluating the long-term efficacy and safety of investigational Viaskin Peanut in peanut-allergic children ages four to 11 years.
The median observed increase from baseline in peanut-specific IgE was greater in the Viaskin Peanut group vs placebo group, respectively, at month 3 (70.1 kilounits of antibody per liter, or kUA/L vs. 9.8 kUA/L) and month 6 (27.4 kUA/L vs. 1.32 kUA/L).
The median observed increase from baseline in peanut-specific IgE was greater in the Viaskin Peanut group vs placebo group, respectively, at month 3 (70.1 kilounits of antibody per liter (“kUA/L”) vs. 9.8 kUA/L) and month 6 (27.4 kUA/L vs. 1.32 kUA/L).
The holder of an MA must establish and maintain a pharmacovigilance system and appoint an individual qualified person for pharmacovigilance who is responsible for oversight of that system. Key obligations include expedited reporting of suspected serious adverse reactions and submission of periodic safety update reports, or PSURs.
The holder of an MA must establish and maintain a pharmacovigilance system and appoint an individual qualified person for pharmacovigilance who is responsible for oversight of that system. Key obligations include expedited reporting of suspected serious adverse reactions and submission of periodic safety update reports (“PSURs”).
Clinical trials of medicinal products in the EU must be conducted in accordance with EU and national regulations and the International Conference on Harmonization, or ICH, guidelines on GCPs, as well as the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.
Clinical trials of medicinal products in the EU must be conducted in accordance with EU and national regulations and the International Conference on Harmonization (“ICH”) guidelines on GCPs, as well as the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.
There was a low discontinuation rate due to treatment-emergent adverse events, or TEAEs, (1.7%), and the overall rate of TEAEs, regardless of relatedness to the treatment, was comparable between treatment and placebo groups, at 95.4% and 89.0%, respectively. The most commonly reported TEAEs were mild to moderate application-site reactions that decreased after month one in both frequency and severity.
There was a low discontinuation rate due to TEAEs (1.7%), and the overall rate of TEAEs, regardless of relatedness to the treatment, was comparable between treatment and placebo groups, at 95.4% and 89.0%, respectively. The most commonly reported TEAEs were mild to moderate application-site reactions that decreased after month one in both frequency and severity.
Viaskin Milk Our second product candidate, Viaskin Milk, is in development for the treatment of cow’s milk protein allergy, (IgE-mediated) or CMPA, in children two to 17 years of age, and received fast track designation from the FDA in September 2016.
Viaskin Milk Our second product candidate, Viaskin Milk, is in development for the treatment of cow’s milk protein allergy (“CMPA”) (IgE-mediated) in children two to 17 years of age, and received fast track designation from the FDA in September 2016.
In the EU, clinical trials are governed by the Clinical Trials Regulation (EU) No. 536/2014, or CTR, which entered into application on January 31, 2022, repealing and replacing the Clinical Trials Directive 2001/20, or CTD. The CTR is intended to harmonize and streamline clinical trial authorizations, simplify adverse-event reporting procedures, improve the supervision of clinical trials and increase transparency.
In the EU, clinical trials are governed by the Clinical Trials Regulation (EU) No. 536/2014 (“CTR”) which entered into application on January 31, 2022, repealing and replacing the Clinical Trials Directive 2001/20 (“CTD”). The CTR is intended to harmonize and streamline clinical trial authorizations, simplify adverse-event reporting procedures, improve the supervision of clinical trials and increase transparency.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeIf 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.
Biggest changeIf 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.
Any future public health crises could materially affect our operations as well as cause significant disruption in the operations and business of third-party manufacturers, CROs, other services providers, and collaborators with whom we conduct business. It is impossible to predict all effects and the ultimate impact of any public health crises.
Any future public health crises could materially affect our operations as well as cause significant disruption in the operations and business of third-party manufacturers, CROs, other services providers, and collaborators with whom we conduct business. It is impossible to predict all effects and the ultimate impact of public health crises.
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. 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.
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.
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.
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.
Security incidents and attendant 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.
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.
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.
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.
Shares issued are registered in individual accounts opened by us or any authorized intermediary, in the name of each shareholder and kept according to the terms and conditions laid down by the legal and regulatory provisions; • approval of at least a majority of the votes held by shareholders present, represented by a proxy, or voting by mail at the relevant ordinary shareholders’ general meeting is required to remove directors with or without cause; • advance notice is required for nominations to the board of directors or for proposing matters to be acted upon at a shareholders’ meeting, except that a vote to remove and replace a director can be proposed at any shareholders’ meeting without notice; • our by-laws can be changed in accordance with applicable laws; • the crossing of certain thresholds has to be disclosed and can impose certain obligations; • transfers of shares shall comply with applicable insider trading rules and regulations and in particular with the Market Abuse Directive and Regulation dated April 16, 2014; and • pursuant to French law, the sections of the by-laws relating to the number of directors and election and removal of a director from office may only be modified by a resolution adopted by at least a two thirds majority vote of our shareholders present, represented by a proxy or voting by mail at the meeting.
Shares issued are registered in individual accounts opened by us or any authorized intermediary, in the name of each shareholder and kept according to the terms and conditions laid down by the legal and regulatory provisions; • approval of at least a majority of the votes held by shareholders present, represented by a proxy, or voting by mail at the relevant ordinary shareholders’ general meeting is required to remove directors with or without cause; F - 64 • advance notice is required for nominations to the board of directors or for proposing matters to be acted upon at a shareholders’ meeting, except that a vote to remove and replace a director can be proposed at any shareholders’ meeting without notice; • our by-laws can be changed in accordance with applicable laws; • the crossing of certain thresholds has to be disclosed and can impose certain obligations; • transfers of shares shall comply with applicable insider trading rules and regulations and in particular with the Market Abuse Directive and Regulation dated April 16, 2014; and • pursuant to French law, the sections of the by-laws relating to the number of directors and election and removal of a director from office may only be modified by a resolution adopted by at least a two thirds majority vote of our shareholders present, represented by a proxy or voting by mail at the meeting.
Our future capital requirements will depend on, and could increase significantly as a result of, many factors including: • the scope, progress in, results and the costs of, our pre-clinical studies and clinical trials and other research and development programs, particularly as we seek regulatory and marketing approvals for our product candidates that successfully complete clinical trials; • the approval of Viaskin Peanut by the FDA, European Commission, or other comparable regulatory authorities; • the costs of commercialization activities, including product sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive regulatory approval, especially in North America; • the costs of securing manufacturing arrangements for commercial production; • revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive regulatory approval; • the scope, prioritization and number of our research and development programs; • the costs, timing and outcome of regulatory review of our product candidates; • the achievement of milestones or occurrence of other developments that trigger payments under our existing collaboration agreements, and any additional collaboration agreements we may enter into; • the extent to which we are obligated to reimburse, or entitled to reimbursement of, clinical trial costs under our existing collaboration agreements and future collaboration agreements, if any; and • the costs involved in filing, prosecuting, enforcing and defending patent claims and other intellectual property rights.
Our future capital requirements will depend on, and could increase significantly as a result of, many factors including: • the scope, progress in, results and the costs of, our pre-clinical studies and clinical trials and other research and development programs, particularly as we seek regulatory and marketing approvals for our product candidates that successfully complete clinical trials; • the approval of Viaskin Peanut by the FDA, European Commission, or other comparable regulatory authorities; • the costs of commercialization activities, including product sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive regulatory approval, especially in North America; • the costs of securing manufacturing arrangements for commercial production; • revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive regulatory approval; • the scope, prioritization and number of our research and development programs; • the costs, timing and outcome of regulatory review of our product candidates; • the achievement of milestones or occurrence of other developments that trigger payments under our existing collaboration agreements, and any additional collaboration agreements we may enter into; • the extent to which we are obligated to reimburse, or entitled to reimbursement of, clinical trial costs under our existing collaboration agreements and future collaboration agreements, if any; and F - 37 • the costs involved in filing, prosecuting, enforcing and defending patent claims and other intellectual property rights.
Furthermore, if we fail to comply with applicable FDA and other regulatory requirements at any stage during this regulatory process, we may encounter or be subject to: • issuance of warning letters, show cause notices or untitled letters describing alleged violations, which may be publicly available; • diminishment of any competitive advantages that such product candidates may have or attain; • suspension, delays or termination in clinical trials or commercialization; • delays or refusal by the FDA or similar foreign regulatory authorities to review pending applications for regulatory approval or supplements to approved applications; • voluntary or mandatory product recalls or seizures; • refusal to permit the import or export of medicinal products or intermediary chemicals; • suspension, restrictions or additional requirements on operations, including of manufacturing or revocation of necessary licenses; • withdrawals, variations or suspensions of regulatory approvals; and • fines, civil penalties, and criminal prosecutions.
Furthermore, if we fail to comply with applicable FDA and other regulatory requirements at any stage during this regulatory process, we may encounter or be subject to: • issuance of warning letters, show cause notices or untitled letters describing alleged violations, which may be publicly available; • diminishment of any competitive advantages that such product candidates may have or attain; • suspension, delays or termination in clinical trials or commercialization; • delays or refusal by the FDA or similar foreign regulatory authorities to review pending applications for regulatory approval or supplements to approved applications; • voluntary or mandatory product recalls or seizures; • refusal to permit the import or export of medicinal products or intermediary chemicals; F - 41 • suspension, restrictions or additional requirements on operations, including of manufacturing or revocation of necessary licenses; • withdrawals, variations or suspensions of regulatory approvals; and • fines, civil penalties, and criminal prosecutions.
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. Patent litigation is costly and time consuming. We may not have sufficient resources to bring these actions to a successful conclusion.
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. We may not have sufficient resources to bring these actions to a successful conclusion.
In addition, many countries limit the enforceability of patents against third parties, including government agencies or government contractors. In these countries, patents may provide limited or no benefit. Patent protection must ultimately be sought on a country-by-country basis, which is an expensive and time-consuming process with uncertain outcomes.
In addition, many countries limit the enforceability of patents against third parties, including government agencies or government contractors. In these countries, patents may provide limited or no benefit. 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.
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.
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.
Collaborations involving our product candidates pose a number of risks, including the following: • collaborators may not have sufficient resources or decide not to devote the necessary resources due to internal constraints such as budget limitations, lack of human resources, or a change in strategic focus; • collaborators may believe our intellectual property is not valid, is not infringed by potential competitors or is unenforceable or the product candidate infringes on the intellectual property rights of others; • collaborators may dispute their responsibility to conduct development and commercialization activities pursuant to the applicable collaboration, including the payment of related costs or the division of any revenues; • collaborators may decide to pursue a competitive product developed outside of the collaboration arrangement; • collaborators may not be able to obtain, or believe they cannot obtain, the necessary regulatory approvals; or • collaborators may delay the development or commercialization of our product candidates in favor of developing or commercializing another party’s product candidate.
Collaborations involving our product candidates pose a number of risks, including the following: • collaborators may not have sufficient resources or decide not to devote the necessary resources due to internal constraints such as budget limitations, lack of human resources, or a change in strategic focus; • collaborators may believe our intellectual property is not valid, is not infringed by potential competitors or is unenforceable or the product candidate infringes on the intellectual property rights of others; F - 51 • collaborators may dispute their responsibility to conduct development and commercialization activities pursuant to the applicable collaboration, including the payment of related costs or the division of any revenues; • collaborators may decide to pursue a competitive product developed outside of the collaboration arrangement; • collaborators may not be able to obtain, or believe they cannot obtain, the necessary regulatory approvals; or • collaborators may delay the development or commercialization of our product candidates in favor of developing or commercializing another party’s product candidate.
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. Developments in patent law could have a negative impact on our business.
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.
Positive results in the studies will be imperative for us to seek regulatory approval before we are permitted to commence commercialization, if ever. The confirmatory study must also be positive post-approval or the FDA may likely seek withdrawal of approval of Viaskin Peanut in the 1 - 3-year-old age group.
Positive results in the studies will be imperative for us to seek regulatory approval before we are permitted to commence commercialization, if ever. The confirmatory study must also be positive post-approval or the FDA may seek withdrawal of approval of Viaskin Peanut in the 1 - 3-year-old age group.
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.
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.
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.
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.
Viaskin Milk will also require substantial additional clinical development, testing, and regulatory approval before we are permitted to commence its commercialization, if ever. Many of our other product candidates are still in pre-clinical or early proof-of-concept phase development.
Viaskin Milk will also require substantial additional clinical development, testing, and regulatory approval before we are permitted to commence its commercialization, if ever. Our other product candidates are still in pre-clinical or early proof-of-concept phase development.
Restrictions under applicable federal, state and foreign healthcare laws and regulations include but are not limited to the following: • 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.
Restrictions under applicable federal, state and foreign healthcare laws and regulations include but are not limited to the following: • 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 F - 49 under federal healthcare programs such as Medicare and Medicaid.
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.
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.
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.
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.
In addition, such interference, 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.
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.
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.
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.
These consequences may include: government enforcement actions (for example, investigations, fines, penalties, audits, and inspections); additional reporting requirements and/or oversight; restrictions on processing sensitive information (including personal data); litigation (including class claims); indemnification obligations; negative publicity; reputational harm; monetary fund diversions; interruptions in our operations (including availability of data); financial loss; and other similar harms.
These consequences may include: government enforcement actions (for example, investigations, fines, penalties, audits, and inspections); additional reporting requirements and/or oversight; restrictions on processing sensitive information (including personal data); litigation (including class claims); indemnification obligations; negative publicity; reputational harm; monetary fund diversions; diversions of management attention; interruptions in our operations (including availability of data); financial loss; and other similar harms.
Obtaining requisite regulatory approval in any country is a complex, lengthy, expensive and uncertain process, and the FDA or the applicable foreign regulatory authority may delay, limit or deny approval of a Viaskin product, for many reasons, including, among others: • we may not be able to demonstrate that a product candidate is a safe and effective treatment, to the satisfaction of the FDA or the applicable foreign regulatory authority; • the results of our clinical trials or the clinical trials conducted by third party academic institutions and included in our application package may not meet the level of statistical or clinical significance required by the FDA or the applicable foreign regulatory authority for regulatory approval; • the FDA or the applicable foreign regulatory authority may disagree with the number, design, size, conduct or implementation of our clinical trials; • the FDA or the applicable foreign regulatory authority may require that we conduct additional clinical trials; • the FDA or the applicable foreign regulatory authority may not approve the formulation, labeling or specifications of a product candidate; • 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; • 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; • the FDA or the applicable foreign regulatory authority may disagree with our analysis or interpretation of data from our pre-clinical studies and clinical trials; • the FDA or the applicable foreign regulatory authority may not accept data generated at our clinical trial sites; • 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; • the FDA or the applicable foreign regulatory authority may require development or implementation of a Risk Evaluation and Mitigation Strategy (or REMS), or comparable foreign requirements, as a condition of approval or post-approval; • the FDA or the applicable foreign regulatory authority may restrict the use of our products to a narrow population; • the FDA or the applicable foreign regulatory authority may not approve the manufacturing processes or facilities of our own or of third-party manufacturers with which we contract, or may issue inspectional findings that require significant expense and time to address; or • the FDA or the applicable foreign regulatory authority may change their approval policies or new legislation governing the approval processes.
Obtaining requisite regulatory approval in any country is a complex, lengthy, expensive and uncertain process, and the FDA or the applicable foreign regulatory authority may delay, limit or deny approval of a Viaskin product, for many reasons, including, among others: • we may not be able to demonstrate that a product candidate is a safe and effective treatment, to the satisfaction of the FDA or the applicable foreign regulatory authority; • the results of our clinical trials or the clinical trials conducted by third party academic institutions and included in our application package may not meet the level of statistical or clinical significance required by the FDA or the applicable foreign regulatory authority for regulatory approval; • the FDA or the applicable foreign regulatory authority may disagree with the number, design, size, conduct or implementation of our clinical trials; • the FDA or the applicable foreign regulatory authority may require that we conduct additional clinical trials; • the FDA or the applicable foreign regulatory authority may not approve the formulation, labeling or specifications of a product candidate; • 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; • the FDA or the applicable foreign regulatory authority may disagree with our analysis or interpretation of data from our pre-clinical studies and clinical trials; • the FDA or the applicable foreign regulatory authority may not accept data generated at our clinical trial sites; • 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; • 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; • the FDA or the applicable foreign regulatory authority may not approve the manufacturing processes or facilities of our own or of third-party manufacturers with which we contract, or may issue inspectional findings that require significant expense and time to address; or • the FDA or the applicable foreign regulatory authority may change their approval policies or new legislation governing the approval processes.
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.
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.
If we enter into arrangements with third parties to perform sales, marketing and distribution services for the commercialization of Viaskin Peanut in the United States or the European Union, if approved, our product revenues or the profitability of these product revenues to us are likely to be lower than if we were to market and sell any product candidates that we develop ourselves.
F - 45 If we enter into arrangements with third parties to perform sales, marketing and distribution services for the commercialization of Viaskin Peanut in the United States or the European Union, if approved, our product revenues or the profitability of these product revenues to us are likely to be lower than if we were to market and sell any product candidates that we develop ourselves.
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, 2023 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.
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.
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. 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. patent law.
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. 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. patent law.
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.
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.
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.
Future pandemics, epidemics or other public health crises (collectively, “public health crises”) could have an impact on our ability to conduct clinical trials, and clinical site initiation, subject enrollment and subject visits (including food challenges) in any of our clinical trials may be suspended or F - 36 delayed due to prioritization of hospital resources toward responding to such public health crises.
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. 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.
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.
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, 2024, our executive officers, directors, current 5% or greater shareholders and affiliated entities, including entities affiliated with Baker Bros.
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.
Investors seeking cash dividends should not purchase the ADSs. 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. Therefore, we may be more restricted in our ability to declare dividends than companies not based in France.
Investors seeking cash dividends should not purchase the ADSs. Further, under F - 63 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.
In addition, over the past few years, bills in the U.S. Congress have been proposed that, if passed, would make changes to the America Invents Act. 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.
In addition, over the past few years, bills in the U.S. Congress have been proposed that, if passed, would make changes to the America Invents Act. 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.
Any of our product candidates for which we, or our collaborators, obtain regulatory approval in the future could be subject to post-marketing requirements, post-marketing commitments or withdrawal from the market and we, and our collaborators, may be subject to substantial penalties if we, or they, fail to comply with regulatory requirements or if we, or they, experience unanticipated problems with our products following approval.
F - 42 Any of our product candidates for which we, or our collaborators, obtain regulatory approval in the future could be subject to post-marketing requirements, post-marketing commitments or withdrawal from the market and we, and our collaborators, may be subject to substantial penalties if we, or they, fail to comply with regulatory requirements or if we, or they, experience unanticipated problems with our products following approval.
Others may have filed, and in the future may file, patent applications covering compositions or products that are similar or identical to our compositions or products. There are many issued U.S. and foreign patents relating to biological or chemical compounds and therapeutic products, and some of these relate to compounds we intend to commercialize.
Others may have filed, and in the future may file, patent applications covering compositions or products that are similar or identical to our compositions or products. There are many issued U.S. and foreign patents relating to F - 52 biological or chemical compounds and therapeutic products, and some of these relate to compounds we intend to commercialize.
The loss of the services of any of these individuals would likely have an adverse effect on us. Our success also will depend upon our ability to attract and retain additional qualified management. Recruiting and retaining qualified scientific, clinical, manufacturing, sales and marketing personnel will also be critical to our success.
The loss of the services of any of these individuals would likely have an adverse effect on us. Our success also will depend upon our ability to attract and retain additional qualified F - 56 management. Recruiting and retaining qualified scientific, clinical, manufacturing, sales and marketing personnel will also be critical to our success.
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. Additionally, these obligations may be subject to differing applications and interpretations, which may be inconsistent or conflict among jurisdictions.
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.
We face substantial competition from companies with considerably more resources and experience than we have, which may result in others discovering, developing, receiving approval for, or commercializing products before or more successfully than us. The biopharmaceuticals industry is highly competitive.
We face substantial competition from companies with considerably more resources and experience than we have, which may result in others discovering, developing, receiving approval for, or commercializing products before or more successfully than us. F - 46 The biopharmaceuticals industry is highly competitive.
We, or the third parties upon whom we depend, may be adversely affected by earthquakes, other natural disasters or outbreaks of contagious diseases and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
F - 44 We, or the third parties upon whom we depend, may be adversely affected by earthquakes, other natural disasters or outbreaks of contagious diseases and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
The completion of trials for Viaskin Peanut and our other product candidates may be delayed for a variety of reasons, including, but not limited to, delays in: • demonstrating sufficient safety and efficacy to obtain regulatory approval to commence a clinical trial; • reaching agreement on acceptable terms with prospective CROs, and clinical trial sites; • validating test methods to support quality testing of the drug substance and drug product; • obtaining sufficient quantities of the drug substance or other materials necessary to conduct clinical trials; • manufacturing sufficient quantities of a product candidate; • 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; • 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; • determining dosing and clinical design and making related adjustments; and • subject enrollment, which is a function of many factors, including the size of the population, the nature of the protocol, the proximity of participants to clinical trial sites, the availability of effective treatments for the relevant disease and the eligibility criteria for the clinical trial.
The completion of trials for Viaskin Peanut and our other product candidates may be delayed for a variety of reasons, including, but not limited to, delays in: • demonstrating sufficient safety and efficacy to obtain regulatory approval to commence a clinical trial; F - 40 • reaching agreement on acceptable terms with prospective CROs and clinical trial sites; • validating test methods to support quality testing of the drug substance and drug product; • obtaining sufficient quantities of the drug substance or other materials necessary to conduct clinical trials; • manufacturing sufficient quantities of a product candidate; • 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; • 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; and • subject enrollment, which is a function of many factors, including the size of the population, the nature of the protocol, the proximity of participants to clinical trial sites, the availability of effective treatments for the relevant disease and the eligibility criteria for the clinical trial.
Risks Related to Product Development, Regulatory Approval and Commercialization We depend almost entirely on the successful development of our novel Viaskin technology. We cannot be certain that we will be able to obtain regulatory approval for, or successfully commercialize, Viaskin products.
F - 38 Risks Related to Product Development, Regulatory Approval and Commercialization We depend almost entirely on the successful development of our novel Viaskin technology. We cannot be certain that we will be able to obtain regulatory approval for, or successfully commercialize, Viaskin products.
Moreover, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act. • 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. • 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.
Moreover, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act. • 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. • 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.
Our product candidates may cause undesirable side effects that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following regulatory approval, if any.
F - 48 Our product candidates may cause undesirable side effects that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following regulatory approval, if any.
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.
Federal, state, local or foreign laws and F - 58 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.
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. • 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. • 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. • 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; 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; state 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.
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. • 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. • 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; 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; 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.
Our product candidates have undergone and/or will be required to undergo clinical trials that are time-consuming and expensive, the outcomes of which are unpredictable, and for which there is a high risk of failure.
F - 39 Our product candidates have undergone and/or will be required to undergo clinical trials that are time-consuming and expensive, the outcomes of which are unpredictable, and for which there is a high risk of failure.
For any taxable year in which we are a PFIC, we will determine whether we will provide to U.S. holders the information required to make a QEF election; for the taxable year ending December 31, 2024, we have provided that information.
For any taxable year in which we are a PFIC, we will determine whether we will provide to U.S. holders the information required to make a QEF election; for the taxable year ending December 31, 2025, we have provided that information.
Delays in the completion and validation of facilities and manufacturing processes of these materials could adversely affect our ability to complete trials and commercialize our products, if any, in a cost-effective and timely manner.
F - 43 Delays in the completion and validation of facilities and manufacturing processes of these materials could adversely affect our ability to complete trials and commercialize our products, if any, in a cost-effective and timely manner.
Biopharmaceutical patents and patent applications involve highly complex legal and factual questions, which, if determined adversely to us, could negatively impact our patent position. The patent positions of biopharmaceutical companies can be highly uncertain and involve complex legal and factual questions.
F - 53 Biopharmaceutical patents and patent applications involve highly complex legal and factual questions, which, if determined adversely to us, could negatively impact our patent position. The patent positions of biopharmaceutical companies can be highly uncertain and involve complex legal and factual questions.
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. 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.
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. 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.
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.
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.
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.
In addition, the stock market in general, and F - 62 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.
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.
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.
A U.S. 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.
A U.S. 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.
We will not seek to protect our intellectual property rights in all jurisdictions throughout the world and we may not be able to adequately enforce our intellectual property rights even in the jurisdictions where we seek protection.
F - 54 We will not seek to protect our intellectual property rights in all jurisdictions throughout the world and we may not be able to adequately enforce our intellectual property rights even in the jurisdictions where we seek protection.
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. 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.
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.
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.
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.
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.
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.
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. As of December 31, 2024, we had 109 full-time employees.
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. As of December 31, 2025, we had 125 full-time employees.
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.
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 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. The FDA identified concerns regarding the impact of system adhesion on efficacy and indicated the need for modifications, and new human factors studies.
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.
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.
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.
Although we maintain such insurance, our insurance coverage may be insufficient to reimburse us for any expenses or losses we may suffer.
F - 57 Although we maintain such insurance, our insurance coverage may be insufficient to reimburse us for any expenses or losses we may suffer.
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.
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.
Our product candidates are regulated as biological products, or biologics, which may subject them to competition sooner than anticipated. 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.
Our product candidates are regulated as biological products, or biologics, which may subject them to competition sooner than anticipated. The BPCIA established an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product.
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. In February 2020, Sanofi announced that it plans to create a new company dedicated to the production and marketing to third parties of API.
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. In February 2020, Sanofi announced that it planned to create a new company dedicated to the production and marketing to third parties of API.
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. For example, HIPAA, as amended by HITECH, imposes specific requirements relating to the privacy, security, and transmission of individually identifiable health information.
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.
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.
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.
A security incident or other interruption disrupt our ability (and that of third parties upon whom we rely) to conduct our business operations. We may expend significant resources or modify our business activities to try to protect against security incidents.
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.
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.
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.
Such disclosures are costly, and the disclosures or the failure to comply with such requirements could lead to adverse consequences. 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.
Such disclosures are costly, and the disclosures or the failure to comply with such requirements could lead to adverse consequences. 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.
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.
F - 66 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.
The U.S. Government, including the FDA, has also experienced recent challenges in personnel staffing related to the new administration, which personnel shortages could adversely impact the review and responsiveness on INDs or BLAs.
The U.S. 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.
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. For such products, the results of appropriate preclinical or clinical trials must be provided in support of a related application for Marketing Authorization.
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. For such products, the results of appropriate preclinical or clinical trials must be provided in support of a related application for MA.
As a result of disclosure of information in filings required of a U.S. public company, particularly as we are no longer a foreign private issuer, our business and financial condition will 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.
As a result of disclosure of information in filings required of a U.S. 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.
These consequences may include, but are not limited to, government enforcement actions (e.g., investigations, fines, penalties, audits, inspections, and similar); litigation (including class-related claims); additional reporting requirements and/or oversight; payment of damages; bans on processing personal data; and orders to destroy or not use personal data.
These consequences may include, but are not limited to, government enforcement actions (e.g., investigations, fines, penalties, audits, inspections, and similar); litigation (including class-related claims) and mass arbitration demands; additional reporting requirements and/or oversight; payment of damages; bans or restrictions on processing personal data; orders to destroy or not use personal data; and imprisonment of company officials.
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.
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.
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.
Manufacturers of products with which we contract are required to operate in accordance with FDA-mandated cGMPs or comparable GMP requirements in foreign countries.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeDepending on the environment and system, we implement and maintain various technical, physical, and organizational measures, processes, standards and policies designed to manage and mitigate material risks from cybersecurity threats to our Information Systems and Data, including, for example: an information systems security policy; incident management; disaster recovery procedures; periodic backup recovery tests; risk assessments; encryption of certain data; network security controls; data segregation for certain systems and environments; access controls; physical security; asset management, tracking, and disposal; systems monitoring; employee training and phishing simulations; penetration tests; outsourced managed detection and response services; maintaining cybersecurity insurance; and having dedicated cybersecurity staff.
Biggest changeThese include, for example: an information systems security policy; security incident management; disaster recovery procedures; periodic backup recovery tests; risk assessments; encryption of certain data; network security controls; data segregation for certain systems and environments; access controls; physical security; asset management, tracking, and disposal; systems monitoring; employee training and phishing simulations; periodic penetration tests; outsourced managed detection and response services; maintaining cybersecurity insurance; and having dedicated cybersecurity staff.
Risk management and strategy We have implemented and maintain various information security processes designed to identify, assess and manage material risks from cybersecurity threats to our critical computer networks, third party hosted services, communications systems, hardware and software, and our critical data, including intellectual property, confidential information that is proprietary, strategic or competitive in nature, and data related to our clinical trials and technology platform (“Information Systems and Data”).
Risk management and strategy We have implemented and maintain various information security processes designed to identify, assess and manage material risks from cybersecurity threats to our critical infrastructure, third party hosted services, communications systems, hardware and software, and our critical data, including intellectual property, confidential information that is proprietary, strategic or competitive in nature, and data related to our clinical trials and technology platform (“Information Systems and Data”).
Risk Factors in this Annual Report on Form 10-K, including 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.
Risk Factors in this Annual Report, including 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.
Our Vice President for Information Systems reports to our CFO. The Vice President for Information Systems is responsible for hiring appropriate personnel, helping to integrate cybersecurity risk considerations into the Company’s overall risk management strategy, and communicating key priorities to relevant personnel.
Our Vice President for Information Systems reports to our Chief Financial Officer. The Vice President for Information Systems is responsible for hiring appropriate personnel, helping to integrate cybersecurity risk considerations into the Company’s overall risk management strategy, and communicating key priorities to relevant personnel.
The audit committee may receive periodic reports from our CFO concerning the Company’s significant threats and risk, including, if applicable, those related to cybersecurity threats, and the processes the Company has implemented to address them. The audit committee also has access to various reports, summaries or presentations related to cybersecurity threats, risk and mitigation.
The audit committee may receive periodic reports from our Chief Financial Officer concerning the Company’s significant threats and risk, including, if applicable, those related to cybersecurity threats, and the processes the Company has implemented to address them. The Audit Committee also may have access to various reports, summaries or presentations related to cybersecurity threats, risk and mitigation.
The cybersecurity component of the Company’s risk mapping and management documentation is updated annually, and our Information Systems security function, led by our Vice President for Information Systems and Director of Information Systems security, prepares cybersecurity roadmaps designed to prioritize our risk management processes and mitigate cybersecurity threats that are more likely to lead to a material impact to our business.
The cybersecurity component of the Company’s risk mapping and management documentation is updated F - 67 annually, and our Information Systems security function prepares cybersecurity roadmaps designed to prioritize our risk management processes and mitigate cybersecurity threats that are more likely to lead to a material impact to our business.
Our cybersecurity incident response and vulnerability management procedures are designed to escalate certain cybersecurity incidents to members of management depending on the impact of the incident, including the CFO, Data Privacy Officer, Company Legal department, and Executive Committee, who work with the Company’s incident response team to help the Company mitigate and remediate cybersecurity incidents of which they are notified.
Our Information System security incident management procedure is designed to escalate certain cybersecurity incidents to members of management depending on the impact of the incident, including the Chief Financial Officer, Data Privacy Officer, Company Legal department, and Executive Committee, who work with the Company’s incident response team to help the Company mitigate and remediate cybersecurity incidents of which they are notified.
Our Information Systems security function identifies and assesses risks from cybersecurity threats by monitoring and evaluating our threat environment using various methods including, for example automated tools, subscribing to and analyzing reports and services that identify cybersecurity threats, conducting scans of the Company’s threat environment, evaluating threats that are reported to us, conducting internal audits, internal threat assessments, and conducting vulnerability assessments.
This function evaluates risks by continuously monitoring and analyzing our threat environment and risk profile using various methods including automated tools, subscribing toreports and services that identify cybersecurity threats, analyzing reports of threats and actors, conducting scans of the Company’s threat environment, evaluating threats that are reported to us, conducting internal audits, internal and external threat assessments, third party threat assessments, and conducting vulnerability assessments.
We use third-party service providers to assist us from time to time to identify, assess, and manage material risks from cybersecurity threats, including for example, cybersecurity software providers, managed cybersecurity service providers, and penetration testing firms.
We use third-party service providers to assist us from time to time to identify, assess, and manage material risks from cybersecurity threats, including for example, cybersecurity software providers, managed cybersecurity service providers, and penetration testing firms. We use third-party service providers to perform a variety of functions throughout our business, such as CROs, CMOs, cloud hosting and other SaaS providers.
Removed
We use third-party service providers to perform a variety of functions throughout our business, such as contract research organizations (CROs), contract manufacturing organizations (CMOs), cloud hosting and other SaaS providers.
Added
Depending on the environment and system, we implement and maintain various technical, physical, and organizational measures, processes, standards and policies designed to manage and mitigate material risks from cybersecurity threats to our Information Systems and Data.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeIn April 2022, we entered into a lease agreement for a 5,799 square foot office in Basking Ridge, New Jersey, which commenced on April 1, 2022 and is effective for 38 months, expiring April 30, 2025. We consider our facilities to be suitable and adequate for the management and operation of our business.
Biggest changeWe also had a 5,799 square foot office in Basking Ridge, New Jersey to support our U.S. operations, which commenced on April 1, 2022 and expired as of June 1, 2025. We consider our facilities to be suitable and adequate for the management and operation of our business.
Item 2. Properties. Our corporate headquarters are located in Châtillon, France. Our principal offices occupy a 2,447 square meter facility, pursuant to a lease agreement dated November, 2023, which commenced as of April 16, 2024 with an expiration in March 2033.
Item 2. Properties. Our corporate headquarters are located in Châtillon, France. Our principal offices occupy a 2,447 square meter facility, pursuant to a lease agreement dated November, 2023, which commenced as of April 16, 2024 with an expiration in March 2033. Our primary U.S. office is located in Warren, New Jersey.
In February 2024, we entered into a sublease agreement, commencing on March 19, 2024 and effective for 70 months, for an office of 16,704 square feet in Warren, New Jersey. We also have facilities in North America that support our U.S. operations.
In February 2024, we entered into a sublease agreement, commencing on March 19, 2024 and effective for 70 months, for an office of 16,704 square feet in Warren, New Jersey.
Removed
The lease agreement for the previous corporate headquarters occupying 4,470 square meter facility in Montrouge, France, signed on March 3, 2015, which expired on May 31, 2024. Our primary U.S. office is located in Warren, New Jersey.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeItem 3. Legal Proceedings. From time to time, we may become subject to various legal proceedings and claims that arise in the ordinary course of our business activities. We are not currently subject to any material legal proceedings. Item 4. Mine Safety Disclosures. Not applicable. PART II
Biggest changeItem 3. Legal Proceedings. From time to time, we may become subject to various legal proceedings and claims that arise in the ordinary course of our business activities. We are not currently subject to any material legal proceedings. Item 4. Mine Safety Disclosures. Not applicable. F - 68 PART II

Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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Biggest changeItem 4. Mine Safety Disclosures. F - 64 PART II F - 65 Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. F - 65 Item 6. [Reserved]. F - 65 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations. F - 66 Item 7A.
Biggest changeItem 4. Mine Safety Disclosures. F - 68 PART II F - 69 Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. F - 69 Item 6. [Reserved]. F - 69 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations. F - 70 Item 7A.
Quantitative and Qualitative Disclosures About Market Risk. F - 75
Quantitative and Qualitative Disclosures About Market Risk. F - 79

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeDividend Policy We have never paid cash dividends on any of our share capital and currently intend to retain our future earnings, if any, to fund the development and growth of our business.
Biggest changeDividend Policy We have never paid cash dividends on any of our share capital and currently intend to retain our future earnings, if any, to fund the development and growth of our business. Purchases of Equity Securities by the Issuer and Affiliated Purchasers None.
Holders of Ordinary Shares As of December 31, 2024, there were approximately 309 holders of record of our ordinary shares and 33 holders of record of our ADSs. The actual number of holders is greater than these numbers of record holders, and includes beneficial owners whose ordinary shares or ADSs are held in street name by brokers and other nominees.
Holders of Ordinary Shares As of December 31, 2025, there were approximately 330 holders of record of our ordinary shares and 64 holders of record of our ADSs. The actual number of holders is greater than these numbers of record holders, and includes beneficial owners whose ordinary shares or ADSs are held in street name by brokers and other nominees.
Removed
Recent Sales of Unregistered Equity Securities During the year ended December 31, 2024, we issued the following unregistered securities: • on March 23, 2024, the issuance of an aggregate of 2,599 ordinary shares to U.S. and on-U.S. employees upon settlement of RSUs; • on May 12, 2024, the issuance of an aggregate of 1,600 ordinary shares to U.S. employees upon settlement of RSUs; • on May 19, 2024, the issuance of an aggregate of 2,500 ordinary shares to U.S. employees upon settlement of RSUs; • on May 22, 2024, the issuance of an aggregate of 22,112 ordinary shares to U.S. and non-U.S. employees upon settlement of RSUs; • on May 24, 2024, the issuance of an aggregate of 32,497 ordinary shares to U.S. and non-U.S. employees upon settlement of RSUs; • on July 29, 2024, the issuance of an aggregate of 5,849 ordinary shares to U.S. employees upon settlement of RSUs; • on September 23, 2024, the issuance of an aggregate of 2,599 ordinary shares to U.S. and non-U.S. employees upon settlement of RSUs; • on November 12, 2024, the issuance of an aggregate of 400 ordinary shares to U.S. employees upon settlement of RSUs; • on November 19, 2024, the issuance of an aggregate of 2,500 ordinary shares to non-U.S. employees upon settlement of RSUs; • on November 20, 2024, the issuance of an aggregate of 97,436 ordinary shares to non-U.S. employees upon settlement of RSUs; • on November 21, 2024, the issuance of an aggregate of 166,874 ordinary shares to U.S. and non-U.S. employees upon settlement of RSUs; • on November 22, 2024, the issuance of an aggregate of 21,925 ordinary shares to U.S. and non-U.S. employees upon settlement of RSUs; and • on November 24, 2024, the issuance of an aggregate of 46,840 ordinary shares to U.S. and non-U.S. employees upon settlement of RSUs None of the foregoing transactions involved any underwriters, underwriting discounts or commissions, or any public offering.
Removed
Unless otherwise specified above, we believe these transactions were exempt from registration under the Securities Act in reliance on Section 4(a)(2) of the Securities Act, Regulation S, Regulation D or Rule 701 promulgated under Section 3(b) of the Securities Act as transactions by an issuer not involving any public offering or under benefit plans and contracts relating to compensation as provided under Rule 701.
Removed
The recipients of the securities in each of these transactions represented their intentions to acquire the securities for investment only and not with a view to or for sale in connection with any distribution thereof. All recipients had adequate access, through their relationships with us, to information about us.
Removed
The sales of these securities were made without any general solicitation or advertising. Purchases of Equity Securities by the Issuer and Affiliated Purchasers None.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeGAAP, for the years ended December 31, 2024 and 2023: December 31, 2024 2023 $ change % of change Operating income 4,151 15,728 (11,577) (74) % Operating expenses Research and development expenses (89,342) (60,223) (29,119) 48 % Sales and marketing expenses (2,659) (2,438) (222) 9 % General and administrative expenses (28,739) (29,500) 762 (3) % Total Operating expenses (120,740) (92,161) (28,579) 31 % Loss from operations (116,589) (76,432) (40,157) 53 % Financial income (expense) 2,726 3,714 (987) (27) % Loss before taxes (113,863) (72,719) (41,144) 57 % Income tax (55) (7) (49) 721 % Net loss (113,918) (72,726) (41,192) 57 % Basic/diluted Net loss per share attributable to shareholders (1.17) (0.76) — — Operating Income The following table summarizes our operating income for the years presented: December 31, 2024 2023 $ change % of change Sales — — — — Other income 4,151 15,728 (11,577) (74) % Research tax credit 4,146 8,766 (4,620) (53) % Other operating income 5 6,962 (6,957) (100) % Total operating income 4,151 15,728 (11,577) (74) % We generated operating income of $4.2 million for the year ended December 31, 2024 compared to $15.7 million for the year ended December 31, 2023.
Biggest changeGAAP, for the years ended December 31, 2025 and 2024: December 31, 2025 2024 $ change % of change Operating income 5,636 4,151 1,485 36 % Operating expenses Research and development expenses (116,682) (89,342) (27,340) 31 % Sales and marketing expenses (3,222) (2,659) (562) 21 % General and administrative expenses (32,788) (28,739) (4,049) 14 % Total Operating expenses (152,692) (120,740) (31,952) 26 % Loss from operations (147,056) (116,589) (30,467) 26 % Financial income (expense) 601 2,726 (2,126) (78) % Loss before taxes (146,456) (113,863) (32,593) 29 % Income tax (491) (55) (436) 789 % Net loss (146,947) (113,918) (33,029) 29 % Basic/diluted Net loss per share attributable to shareholders (1.05) (1.17) — — Operating Income The following table summarizes our operating income for the years presented: December 31, 2025 2024 $ change % of change Research tax credit 5,636 4,146 1,489 36 % Other operating income — 5 (5) Total Operating income 5,636 4,151 1,485 36 % The Company did not generate Revenue from operating activities in 2025 or 2024.
Our therapeutic approach is based on epicutaneous immunotherapy, or EPIT, our proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin, an epicutaneous patch (i.e., a skin patch). We have generated significant data demonstrating that Viaskin’s mechanism of action is novel and differentiated.
Our therapeutic approach is based on EPIT, our proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin, an epicutaneous patch (i.e., a skin patch). We have generated significant data demonstrating that Viaskin’s mechanism of action is novel and differentiated.
Please also see the section titled “Forward-Looking Statements.” Overview We are a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin.
Please also see the section titled “Forward-Looking Statements.” Overview We are a late-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin.
Results of Operations Comparison of the Years Ended December 31, 2024 and 2023 The following table summarizes the results of our operations, derived from our consolidated financial statements, prepared in compliance with generally accepted accounting principles in the United States, or U.S.
F - 71 Results of Operations Comparison of the Years Ended December 31, 2025 and 2024 The following table summarizes the results of our operations, derived from our consolidated financial statements, prepared in compliance with generally accepted accounting principles in the United States, or U.S.
Subsequent to December 31, 2024, the Company raised additional proceeds in a private placement financing (the “2025 PIPE”) consisting of i) a share capital increase without preferential subscription rights reserved to categories of persons satisfying determined characteristics pursuant to the 24th resolution of the general meeting of shareholders of May 16, 2024 (the "2024 General Meeting") completed on April 7 2025 for an amount of €38 million, consisting of the issuance of (i) 34,090,004 new shares at a par value of €0.10 (the "New Shares") each with warrants of the Company attached (the "ABSA Warrants", and together with the New Shares, the "ABSA") at a subscription price of €1.1136 per ABSA and (ii) up to 59,657,507 additional new shares, if all the ABSA Warrants attached to the New Shares are exercised (the "ABSA Warrant Shares"); and ii) the issue through an offering reserved to categories of persons satisfying determined characteristics of 71,005,656 units (the “PFW-BS-PFW”) completed on April 7, 2025 for an amount of €79 million at a subscription price of €1.1136 per PFW-BS-PFW (of which €1.1036 will have been prefunded on the issue date), each PFW-BS-PFW consisting of one pre-funded warrant to subscribe for one share of the Company (the "First Pre-Funded Warrants") and one warrant (the "BS Warrants") to subscribe to one second pre-funded warrants (the "Second Pre-Funded Warrants"), each of which entitles the holder to subscribe for 1.75 shares of the Company (the "Second PFW Shares"), allowing to issue up to 71,005,656 additional new shares if all the First Pre-Funded Warrants are exercised (the "First PFW Shares") and up to 124,259,898 additional new shares if all the Second Pre-Funded Warrants are exercised (the "Second PFW Shares", together with the ABSA Warrant Shares and the First Pre-Funded Warrant Shares, the "Warrant Shares", and together with the New Shares, the "Offered Shares").
Financing March 2025 PIPE Financing The Company raised proceeds in the 2025 PIPE consisting of i) a share capital increase without preferential subscription rights reserved to categories of persons satisfying determined characteristics pursuant to the 24th resolution of the 2024 General Meeting completed on April 7 2025, for an amount of €38 million ($40 million), consisting of the issuance of (i) 34,090,004 new shares at a par value of €0.10 (the "New Shares") each with warrants of the Company attached (the "ABSA Warrants", and together with the New Shares, the "ABSA") at a subscription price of €1.1136 per ABSA and (ii) up to 59,657,507 additional new shares, if all the ABSA Warrants attached to the New Shares are exercised (the "ABSA Warrant Shares"); and ii) the issue through an offering reserved to categories of persons satisfying determined characteristics of 71,005,656 units (the “PFW-BS-PFW”) completed on April 7, 2025 for an amount of €79 million ($85 million) at a subscription price of €1.1136 per PFW-BS-PFW (of which €1.1036 will have been prefunded on the issue date), each PFW-BS-PFW consisting of one pre-funded warrant to subscribe for one share of the Company (the "First Pre-Funded Warrants") and one warrant (the "BS Warrants") to subscribe to one second pre-funded warrants (the "Second Pre-Funded Warrants"), each of which entitles the holder to subscribe for 1.75 shares of the Company (the "Second PFW Shares"), allowing to issue up to 71,005,656 additional new shares if all the First Pre-Funded Warrants are exercised (the "First PFW Shares") and up to 124,259,898 additional new shares if all the Second Pre-Funded Warrants are exercised (the "Second PFW Shares", together with the ABSA Warrant Shares and the First Pre-Funded Warrant Shares, the "Warrant Shares", and together with the New Shares, the "Offered Shares").
Net loss per share (based on the weighted average number of shares outstanding over the period) was $1.17 and $0.76 for the year ended December 31, 2024 and 2023, respectively.
Net loss per share (based on the weighted average number of shares outstanding over the period) was $1.05 and $1.17 for the year ended December 31, 2025 and 2024, respectively.
Income tax Our income tax expense was $55 thousand for the year ended December 31, 2024, compared to an income tax expense of $7 thousand for the year ended December 31, 2023. Net loss Net loss was $113.9 million for the year ended December 31, 2024, compared to $72.7 million for the year ended December 31, 2023.
Income tax Our income tax expense was $491 thousand for the year ended December 31, 2025, compared to an income tax expense of $55 thousand for the year ended December 31, 2024. Net loss Net loss was $146.9 million for the year ended December 31, 2025, compared to $113.9 million for the year ended December 31, 2024.
We may, and intend to, take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as we are a smaller reporting company.
Smaller Reporting Company Status We are a smaller reporting company as defined in the Securities Exchange Act of 1934, as amended. We may, and intend to, take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as we are a smaller reporting company.
Our most advanced product candidate is Viaskin Peanut, which has been evaluated as a potential therapy for children with peanut allergy in twelve clinical trials, including three Phase 2 trials and four completed Phase 3 trials. We have two ongoing Phase 3 trial of Viaskin Peanut in children ages one to three and ages four to seven with peanut allergy.
Our most advanced product candidate is Viaskin Peanut, which has been evaluated as a potential therapy for children with peanut allergy in twelve clinical trials, including three Phase 2 trials and four completed Phase 3 trials.
Liquidity and Capital Resources Financial Condition On December 31, 2024, we held $32.5 million in cash and cash equivalents compared to $141.4 million of cash and cash equivalents on December 31, 2023. Net cash used for operating activities was $104.5 million and $79.7 million for the years ended December 31, 2024 and 2023, respectively.
Financial Condition On December 31, 2025, we held $194.2 million in cash and cash equivalents compared to $32.5 million of cash and cash equivalents on December 31, 2024. Net cash used for operating activities was $121.2 million and $104.5 million for the years ended December 31, 2025 and 2024, respectively.
With the receipt of the aforementioned proceeds, and based on its current operations, plans, and assumptions examined by the Board on March 23, 2025, the Company estimates that its cash and cash equivalents are sufficient to fund its operations into June 2026.
With the receipt of the aforementioned proceeds, and based on its current operations, plans, and assumptions, the Company estimates that its cash and cash equivalents are sufficient to fund its operations into the second quarter of 2027.
The actual value of our assets, liabilities and shareholders’ equity and of our earnings could differ from the value derived from these estimates if conditions changed and these changes had an impact on the assumptions adopted. We believe that the most significant management judgments and assumptions in the preparation of our financial statements are described below.
The actual value of our assets, liabilities and shareholders’ equity and of our earnings could differ from the value derived from these estimates if conditions changed and these changes had an impact on the assumptions adopted.
Under the fair value recognition provisions of this guidance, share-based compensation is measured at the grant date based on the fair value of the award and is recognized as expense, net of estimated forfeitures, over the requisite service period, which is generally the vesting period of the respective award.
Equity awards are measured at grant‑date fair value and recognized as compensation expense, net of estimated forfeitures, over the requisite service period, which generally corresponds to the vesting period of the respective awards.
The following table presents our material expenses commitments for future periods: Material Cash Requirements Due by the Year Ended December 31, 2025 2026 2027 Thereafter Total (Amounts in thousands) Operating leases 836 1,228 1,237 5,136 8,437 Purchase obligations - Obligations Under the Terms of CRO Agreements 8,439 1,541 502 48 10,530 Total 9,275 2,769 1,739 5,184 18,967 The commitment amounts in the table above are associated with contracts that are enforceable and legally binding and that specify all significant terms, including interest on long-term debt, fixed or minimum services to be used, fixed, minimum or variable price provisions, and the approximate timing of the actions under the contracts.
F - 74 Material expenses commitments The following table presents our material expenses commitments for future periods: Material Cash Requirements Due by the Year Ended December 31, 2026 2027 2028 Thereafter Total (Amounts in million) Operating leases 0.8 1.2 1.2 5.1 8.4 Purchase obligations - Obligations Under the Terms of CRO Agreements 26.6 22.0 22.1 19.1 89.8 Purchase obligations - Obligations Under the Terms of CMO Agreements 17.4 15.6 15.7 — 48.7 Total 44.8 38.9 39.0 24.2 147.0 The commitment amounts in the table above are associated with contracts that are enforceable and legally binding and that specify all significant terms, including fixed or minimum services to be used, fixed, minimum or variable price provisions, and the approximate timing of the actions under the contracts.
The liquidity agreement has a term of one year and will renew automatically unless otherwise terminated by either party. Critical Accounting Policies and Significant Judgments and Estimates Our financial statements are prepared in accordance with U.S. GAAP. Some of the accounting methods and policies used in preparing our financial statements under U.S.
Critical Accounting Policies and Significant Judgments and Estimates Our financial statements are prepared in accordance with U.S. GAAP. Some of the accounting methods and policies used in preparing our financial statements under U.S.
Determining the fair value of the share-based payments at the grant date requires judgment. We calculated the fair value of stock options on the grant date using the Black-Scholes option pricing model. The Black-Scholes model requires the input of highly subjective assumptions, including the expected volatility, expected term, risk-free interest rate and dividend yield.
Valuation methodology and key assumptions The fair value of stock options is estimated at the grant date using the Black‑Scholes option pricing model, which requires management to make a number of highly subjective assumptions, including expected volatility, expected term, risk‑free interest rate and expected dividend yield.
General and Administrative Expenses The following table summarizes our general and administrative expenses for the years presented: December 31, 2024 2023 $ change % of change General & Administrative expenses External professional services 10,052 8,750 1,302 15 % Employee-related costs 8,981 8,201 780 10 % Share-based payment expenses 2,161 3,388 (1,227) (36) % Depreciation, amortization and other costs 7,545 9,161 (1,617) (18) % Total General & Administrative expenses 28,739 29,500 (762) (3) % General and administrative expenses decreased by $(0.8) million for the year ended December 31, 2024, compared to the year ended December 31, 2023.
General and Administrative The following table summarizes our general and administrative expenses for the years presented: December 31, 2025 2024 $ change % of change General & Administrative expenses External professional services 9,072 10,052 (980) (10) % Employee-related costs 12,972 8,981 3,991 44 % Share-based payment expenses 3,012 2,161 851 39 % Depreciation, amortization and other costs 7,731 7,545 186 2 % Total General & Administrative expenses 32,788 28,739 4,049 14 % General and administrative expenses increased by $4.0 million for the year ended December 31, 2025, compared to the year ended December 31, 2024.
Sales and Marketing Expenses The following table summarizes our sales and marketing expenses for the years presented: December 31, 2024 2023 $ change % of change Sales & Marketing expenses External professional services and other costs 1,770 1,684 86 5 % Employee-related costs incl. share-based payment expenses 890 754 136 18 % Total Sales & Marketing expenses 2,659 2,438 222 9 % Sales and marketing expenses increased by $0.2 million for the year ended December 31, 2024 compared to the year ended December 31, 2023, primarily to support pre-commercialization activities for Viaskin Peanut in North America.
The following table summarizes our sales and marketing expenses for the years presented: December 31, 2025 2024 $ change % of change Sales & Marketing expenses External professional services and other costs 1,967 1,770 197 11 % Employee-related costs incl. share-based payment expenses 1,254 890 364 41 % Total Sales & Marketing expenses 3,222 2,659 561 21 % Sales and marketing expenses increased by $0.6 million for the year ended December 31, 2025 compared to the year ended December 31, 2024.
On April 7, 2025, the Company received gross proceeds of $125.5 million (€116.3 million) from the issuance of the ABSA and PFW-BS-PFW, as described in Note 20.
The Company received initial gross proceeds of $125.5 million (€116.3 million) on April 7, 2025.
Savings and deposit accounts generate a limited amount of interest income, with very low counterparty risks. We expect to continue this investment strategy.
Savings and deposit accounts generate a limited amount of interest income, with very low counterparty risks. We expect to continue this investment strategy. Our financial income was $0.6 million in 2025 and $2.7 million in 2024, and primarily includes the financial income on our financial assets and foreign exchange gains.
The following table provides a breakdown of our direct Research and Development expenses for our two lead development programs, as well as expenses not allocated to the programs and share-based compensation expenses included in Research and Development expenses, for the years ended December 31, 2024 and 2023, respectively: December 31, 2024 2023 Viaskin Peanut(1) 80,479 60,329 As a percentage of research and development expenses, excluding share- 93 % 105 % based compensation Expense(2) Research and development expenses related to Viaskin Milk(1) 3,638 6,019 As a percentage of research and development expenses excluding share-based compensation Expense(3) 4 % 10 % Other research and development expenses(1) 2,881 (8,621) Total research and development expenses, excluding share-based compensation expense 86,999 57,727 Share-based compensation expenses included in research and development expenses 2,343 2,496 Total research and development expenses 89,343 60,223 (1) Excludes employee share-based compensation expense after $19.9 million loss on completion accrual reversal as of December 2023.
The following table provides a breakdown of our direct Research and Development expenses for our two lead development programs, as well as expenses not allocated to the programs and share-based compensation expenses included in Research and Development expenses, for the years ended December 31, 2025 and 2024, respectively: December 31, 2025 2024 Viaskin Peanut (1) 107,221 80,479 As a percentage of research and development expenses, excluding share-based compensation Expense 94 % 93 % Research and development expenses related to Viaskin Milk (1) 222 3,638 As a percentage of research and development expenses excluding share-based compensation Expense — % 4 % Other research and development expenses (1) 6,978 2,881 Total research and development expenses, excluding share-based compensation expense 114,421 86,999 Share-based compensation expenses included in research and development expenses 2,261 2,343 Total research and development expenses 116,682 89,343 (1) Excludes employee share-based compensation expense Sales and Marketing Sales and marketing expense consists primarily of personnel costs, consultant fees and share-based compensation for sales and marketing employees, as well as fees related to pre-commercialization activities for Viaskin Peanut in North America and in the European Union.
Our Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company has incurred operating losses and negative cash flows from operations since inception.
Our Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. All assumptions pertaining to this estimate are detailed below in the Liquidity and Capital Resources discussion .
Other Operating Income Research Tax Credits The research tax credit ( crédit d’impôt recherche , or CIR) is granted to companies by the French tax authorities in order to encourage them to conduct technical and scientific research.
This caption consists of Research Tax Credit ( crédit d’impôt recherche , or CIR) that is granted to companies by the French tax authorities in order to encourage them to conduct technical and scientific researches. The Company was granted $5.6 million for the year ended December 31, 2025 compared to $4.2 million for the year ended December 31, 2024.
See Note 1 to our financial statements for a description of our other significant accounting policies.
We believe that the most significant management judgments and assumptions in the preparation of our financial statements are described in Note 1 to our financial statements for a description of our other significant accounting policies.
We expect that our Research and Development expenses will continue to increase in the foreseeable future as we initiate clinical trials for certain product candidates and pursue later stages of clinical development of our product candidates. In the year ended December 31, 2024, we spent $89.3 million in Research and Development expenses to advance the development of our product candidates.
In the year ended December 31, 2025, we spent $116.7 million in Research and Development expenses to advance the development of our product candidates.
Operating Expenses Since our inception, our operating expenses have consisted primarily of Research and Development activities, General and Administration costs and to lesser extent sales and marketing costs. Research and Development Expenses Research and Development expenses comprise clinical trials direct costs as well as salaries, share-based payments and benefits for internal Research and Development personnel.
The increase is the result of more eligible activities were carried out in the period. Operating Expenses Since our inception, our operating expenses have consisted primarily of Research and Development activities, General and Administration costs and to lesser extent sales and marketing costs.
Employee-related costs, excluding share-based payments, increased by $2.8 million for the year ended December 31, 2024 compared to the year ended December 31, 2023 due to the recruitment of 12 full-time employees (“FTE”) in Medical, Quality and Regulatory Affairs, mostly based in the U.S.
F - 72 Employee-related costs, excluding share-based payments, increased by $3.3 million for the year ended December 31, 2025 compared to the year ended December 31, 2024 primarily driven by growth in full-time employees (“FTE”). This increase reflects the full-year impact in 2025 of hires made in 2024, combined with additional recruitments in 2025.
As of December 31, 2024, expenses associated with the ongoing trials amounted globally to $170.3 million, and we had non-cancellable contractual obligations with CRO until the year ended 2026 amounting to $10.0 million. Cash flows The table below summarizes our sources and uses of cash for the years ended December 31, 2024 and 2023.
Off-Balance Sheet Arrangements In connection with the launch of our clinical trials , we signed agreements with several CROs. As of December 31, 2025, expenses associated with the ongoing trials amounted globally to $32.7 million, and we had non-cancellable contractual obligations with CRO until the year ended 2027 amounting to $48.6 million.
Exercise price The exercise price of our stock options is based on the fair market value of our ordinary shares. Risk-free interest rate The risk-free interest rate is based on French government bonds (GFRN) with a maturity corresponding to the maturity of the share options.
These assumptions are inherently uncertain and require significant judgment. • Exercise price of stock options is based on the fair market value of the Company’s ordinary shares at the grant date. • Risk‑free interest rate is determined using French government bonds (GFRN) with a maturity corresponding to the expected term of the stock options. • Expected term represents the period over which stock options are expected to remain outstanding and is determined based on the average expected life of the options, taking into account vesting conditions and historical exercise behavior.
This increase is offset by a decrease in Depreciation, amortization and other costs by $(1.6) million for the year ended December 31, 2024, compared to the year ended December 31, 2023 primarily due to the accrual reversal on the Montrouge office revamping.
Depreciation, amortization and other costs increased by $2.6 million for the year ended December 31, 2025 compared to the year ended December 31, 2024, consequently to an accrual reversal related to CRO activities in the prior year, had a positive impact on the income statement and offsets the recurring depreciation and amortization.
Dollars) 2024 2023 $ change % of change Net cash flow used in operating activities (104,474) (79,653) (24,821) 31 % Net cash flow used in investing activities (757.0) (808.3) 51.304 (6) % Net cash flow provided by financing activities 587 6,767 (6,180) (91) % Effect of exchange rate changes on cash and cash equivalents (4,268) 5,867 (10,135) (173) % Net (decrease) increase in cash and cash equivalents (108,913) (67,827) (41,085) 61 % Operating Activities Our net cash flows used in operating activities were $104.5 million and $79.7 million in 2024 and 2023 respectively.
Dollars) 2025 2024 $ change Net cash flow used in operating activities (121,181) (104,474) (16,707) Net cash flow used in investing activities (1,369) (757.3) (612.016) Net cash flow provided by financing activities 276,182 587 275,596 Effect of exchange rate changes on cash and cash equivalents 8,080 (4,268) 12,348 Net (decrease) increase in cash and cash equivalents 161,711 (108,913) 270,624 F - 75 Operating Activities Our net cash flows used in operating activities were $121.2 million and $104.5 million for the years ended December 31, 2025 and 2024 respectively.
Pre-funded warrants The Company has assessed the pre-funded warrants for appropriate equity or liability classification. During this assessment, the Company determined the pre-funded warrants are freestanding instruments that do not meet the definition of a liability pursuant to ASC 480 and do not meet the definition of a derivative pursuant to ASC 815.
The Company concluded that the pre‑funded warrants do not meet the criteria for liability classification under ASC 480, as they are freestanding, provide for a fixed number of shares upon exercise, and do not obligate the Company to transfer cash or repurchase shares.
Operating Expenses Research and Development Expenses The following table summarizes our research and development expenses for the years presented: December 31, 2024 2023 $ change % of change Research and Development expenses External clinical-related expenses 62,448 49,044 13,404 27 % Employee-related costs 17,213 14,401 2,812 20 % Share-based payment expenses 2,343 2,496 (153) (6) % Depreciation and amortization (719) (13,658) 12,939 (95) % Other costs 8,058 7,940 118 1 % Total Research and Development expenses 89,342 60,223 29,120 48 % Research and Development expenses increased by $29.1 million for the year ended December 31, 2024 compared to the year ended December 31, 2023, mainly due to external clinical-related expenses increasing by $13.4 million from both an increase in participant enrollment in the VITESSE Phase 3 clinical trial and the preparatory activities for the COMFORT studies.
Research and Development Expenses The following table summarizes our research and development expenses for the years presented: December 31, 2025 2024 $ change % of change Research and Development expenses External clinical-related expenses 67,949 61,060 6,890 11% Employee-related costs 20,522 17,213 3,309 19% Pre-Commercial Inventory 16,062 1,388 14,674 1057% Share-based payment expenses 2,261 2,343 (82) (4)% Depreciation, amortization and other costs 9,889 7,338 2,551 35% Total Research and Development expenses 116,682 89,342 27,341 31% Research and Development expenses increased by $27.3 million for the year ended December 31, 2025 compared to the year ended December 31, 2024.
Our net cash flows provided by financing activities totaled $0.6 million in 2024 and $6.8 million in 2023, mainly consisting of the proceeds from our ATM program., Sources of Liquidity and Material Cash Requirements 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.
In the year ending December 31, 2025, we recorded a net loss of $146.9 million. Our net cash flows provided by financing activities totaled $276.2 million in 2025 and $0.6 million in 2024, mainly consisting of the proceeds from the 2025 PIPE and sales from our ATM program.
External professional services increased by $1.3 million for the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due to one-time costs associated with (1) office moves in France and the U.S, (2) financing activities and (3) trademark and patent activities.
These increases were partially offset by a $(1.0) million decrease in external professional services, primarily due to the absence of prior‑year one‑time expenses related to office relocations in France and the United States, as well as reduced trademark and patent‑related activities.
Expected term We determine the expected term based on the average period the stock options are expected to remain outstanding. Expected volatility We determine the expected volatility based on the historical data period corresponding to the stock options expected maturity.
F - 76 • Expected volatility is determined based on historical share price data over a period consistent with the expected maturity of the stock options.
Removed
Financial Overview Since our inception, we have primarily funded our operations with equity financings, and, to a lesser extent, public assistance aimed at supporting innovation and payments associated with research tax credit (crédit d’impôt recherche).
Added
We have two ongoing Phase 3 trial of Viaskin Peanut in children ages one to three and ages four to seven with peanut allergy. 2025 Year in review In 2025, the Company made significant progress advancing the VIASKIN Peanut patch toward commercialization (if approved), secured transformative financing, and identified regulatory pathways for our product candidates through discussions with and written responses from the FDA.
Removed
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. The Company has incurred operating losses and negative cash flows from operations since inception.
Added
As we enter 2026, our focus shifts toward commercialization and laying the groundwork to transform the lives of children living with peanut allergy. Since March 2025, we have increased cash and cash equivalents through our financing activities.
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.
Added
We believe our cash and cash equivalents, (as of the date of this report as of December 31, 2025), are sufficient to pursue operations and prepare for the potential U.S. launch of the VIASKIN Peanut patch for children aged 4–7, if approved.
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.
Added
The Company has proven our ability to perform under pressure and achieve key results, as seen in the announcement of the positive topline results of the VITESSE clinical study and successful financing. The Company’s goal is to broaden FDA-approved options for pediatric peanut allergy while delivering value to stakeholders.
Removed
We imay needadditional capital as we prepare for the launch of Viaskin Peanut, if approved, and continue other research and development efforts. We may seek to finance our future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of non-dilutive financings.
Added
On January 16, 2026, the Company announced additional gross proceeds of $195 million (€166.7 million at the exchange rate of 1 EUR = $1.17) resulting from the full exercise of the ABSA Warrants and BS Warrants, following the announcement of the positive VITESSE Topline Results on December 16, 2025.
Removed
We cannot guarantee that we will be able to obtain the necessary financing to meet our needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets resulting from geopolitical instability, macroeconomic conditions, global health crises, or other factors.
Added
Of these proceeds, $100.7 million in gross proceeds (€85.7 million, at the exchange rate of 1 EUR = $1.17) was received as of December 31, 2025, with the remaining amount received in January 2026. The Accounting treatment is detailed into Note 1 Nature of the business and principles and accounting methods, Significant contracts .
Removed
If we are not successful in our financing objectives, we could have to scale back our operations, notably by delaying or reducing the scope of our research and development efforts or obtain financing through arrangements with collaborators or others that may require us to relinquish rights to our product candidates that we might otherwise seek to develop or commercialize independently.
Added
F - 70 At-The-Market (ATM) equity program offering In September 2025, the Company entered into a Sales Agreement (the “Sales Agreement”) with Citizens JMP Securities, LLC (“Citizens”), with respect to an equity offering program (the “ATM Offering”) pursuant to which the Company may offer and sell ADSs, from time to time, through Citizens as its sales agent.
Removed
We anticipate that our expenses will increase substantially in connection with our ongoing activities, as we: • continue our research, pre-clinical and clinical development of our product candidates, in particular expanding the scope of our trials for Viaskin Peanut; • seek regulatory and marketing approvals and pursue commercial activities for Viaskin Peanut, primarily in North America and in the European Union; • seek regulatory and marketing approvals for our other product candidates that successfully complete clinical trials; • establish a sales, marketing and distribution infrastructure to commercialize Viaskin Peanut, if approved, and any other products for which we may obtain marketing approval, especially in North America and in the European Union; • further develop the manufacturing process for our product candidates; • change or add additional manufacturers or suppliers; • initiate and conduct any post-approval clinical trials, if required by the FDA or by the EMA, for our approved products, if any; • initiate additional pre-clinical, clinical or other studies for our product candidates; • seek to identify and validate additional product candidates; • acquire or in-license other product candidates and technologies; • make milestone or meet other payments deadlines under any in-license agreements; • maintain, protect and expand our intellectual property portfolio; • attract and retain new and existing skilled personnel; • add operational, financial and management information systems and personnel, including personnel to support our product development and commercialization efforts, as well as a company listed on both the U.S. and French stock markets; • experience any delays or encounter issues with any of the above.
Added
Pursuant to the Sales Agreement and a prospectus supplement the Company has filed related to the ATM Offering, the Company may offer and sell ADSs having an aggregate offering price of up to $150.0 million from time to time through Citizens.
Removed
The Company does not generate product revenue and continues to prepare for the potential launch of its first product in the United States and in the European Union, if approved. Since its inception, the Company has primarily funded its operations through equity financings, as well as public assistance and research tax credit.
Added
The issuance and sale, if any, of the ADSs by the Company under the Sales Agreement will be made pursuant to the Company’s previously filed and effective registration statement on Form S-3 (Registration Statement No. 333-271166).
Removed
Prior to 2022, the Company underwent restructuring efforts, scaled down certain clinical programs, and engaged with regulatory authorities to advance Viaskin Peanut’s approval process in the United States and European Union. In 2022, the Company secured a private placement financing of $194 million and lifted a partial clinical hold from the FDA on its VITESSE Phase 3 clinical study.
Added
Sales of the Company’s ADSs, if any, in the ATM Offering may be made in sales deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act from time to time.
Removed
Furthermore, should all Warrant Shares be issued, representing potential additional gross proceeds of up to $181.4 million (€168.2 million), the Company estimates that it could extend its financial visibility into 2028, covering the period through the potential commercialization of Viaskin Peanut in the U.S., if approved.
Added
Pursuant to the ATM Offering, the Company received (i) a total gross amount of $30 million from the sale of 11,538,460 Ordinary Shares (underlying 2,307,692 ADSs) on October 6, 2025, (ii) a total gross amount of $30 million from the sale of 10,714,300 Ordinary Shares (underlying 2,142,860 ADSs) on October 29, 2025, and (iii) a total gross amount of $5 million from the sale of 1,700,000 Ordinary Shares (underlying 340,000 ADSs) on November 19, 2025.
Removed
Given the Company’s historical operating losses and reliance on external financings, the Company may still seek additional capital for future needs through a combination of public or private equity or debt financings, collaborations, licensing agreements, and other funding options.
Added
Clinical & Regulatory On January 8, 2025, the Company announced positive 3-year results from EPITOPE Phase 3 Open-Label Extension Study, a Phase 3 clinical trial. The EPITOPE OLE data demonstrated continued improvement in treatment benefit of VIASKIN® Peanut patch in toddlers 1 – 3 years through 36 months.
Removed
While recent financing events have improved the Company’s financial position, access to additional capital in the future remains subject to market conditions and investor interest. Business Trends We engage in substantial research and development efforts to develop innovative pharmaceutical product candidates.
Added
On March 24, 2025, the Company secured an agreement with FDA on Safety Exposure Data required for BLA for Viaskin® Peanut Patch in 4 – 7-year-olds, accelerating the timeline for a BLA filing to the first half of 2026.
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Research and development expense consists primarily of: • cost of third-party contractors such as contract research organizations, or CROs, that conduct our non-clinical studies and clinical trials; • personnel costs, including salaries, related benefits and share-based compensation, for our employees engaged in scientific research and development functions; • purchases, real-estate leasing costs, as well as conferences and travel costs; and • depreciation, amortization and provisions.
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On June 25, 2025, the Company announced the first subject screened in COMFORT Toddlers Supplemental Safety Study in Peanut Allergic Toddlers 1 – 3 Years Old. On November 11, 2025, the Company announced the last‑patient‑last‑visit in the VITESSE Phase 3 clinical trial evaluating the VIASKIN® Peanut patch in peanut‑allergic children aged 4 to 7 years.
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Our direct research and development expenses consist principally of external costs, such as startup fees paid to investigators, consultants, central laboratories, and CROs in connection with our clinical trials, and costs related to acquiring and manufacturing clinical study materials.
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On December 16, 2025, the Company announced positive Topline Results from Phase 3 VITESSE Trial of VIASKIN® Peanut Patch in Peanut Allergic Children Aged 4-7 Years. • VITESSE met its primary endpoint: the lower bound of the 95% confidence interval the difference between treatment arms was 24.5%, exceeding the prespecified threshold of 15%. • 46.6% of children treated with the VIASKIN® Peanut patch met response criteria at 12 months, compared to 14.8% of children in the placebo arm. • Safety results were consistent with the safety profile observed in the VIASKIN Peanut clinical program to date. • BLA submission in 4-7-year-olds on track for the first half of 2026. • Achievement of primary endpoint triggers an acceleration of the exercise period of certain warrants issued pursuant to the 2025 PIPE financing The clinical development history of the program is described into Item 1 Business: Our Viaskin Technology Platform of this document.
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We do not allocate personnel-related costs, costs associated with our general platform improvements, depreciation or other indirect costs to specific programs, as they are deployed across multiple projects under development and, as such, are separately classified as personnel and other expenses. Research and Development activities are central to our business.
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The Company relies on various subcontractors to conduct its operations, the principal categories of which include: • CROs: These leading international organizations perform, on behalf of the Company, all activities related to regulatory clinical trials once the study protocol has been finalized. • CMOs: As the Company does not currently hold the regulatory status of a pharmaceutical establishment, these entities manufacture the batches of patches required for preclinical and clinical development on the Company’s behalf.
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Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials.
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The Company’s dedicated partners also supply the proteins necessary for the manufacture of patches’batches, as well as various patch components and other materials required for production. A summary of these agreements is provided in Item 1 Business : Manufacturing and Supply of this document.
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(2) If we exclude MAG1C impact the percentage of research and development expenses related to Viaskin Peanut in 2023 would be 84%. (3) If we exclude MAG1C impact the percentage of research and development expenses related to Viaskin Milk in 2023 would be 8%.
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Governance On July 22, 2025, the Company announced the appointment of James Briggs as Chief Human Resources Officer, succeeding Caroline Daniere. James Briggs leads key initiatives supporting DBV’s transition from a development‑stage biotechnology company to a potential commercial‑stage organization.
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We cannot determine with certainty the duration and completion costs of the current or future clinical trials of our product candidates or if, when, or to what extent we will generate revenue from the commercialization and sale of any of our product candidates that obtain regulatory approval.
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On September 18, 2025, the Company announced the resignation of Daniel Soland from his position as a member of the Company’s Board of Directors, effective immediately. On October 30, 2025, the Company announced the provisional appointment of a new independent director, Dr.
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We may never succeed in achieving regulatory approval for any of our product candidates.
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Philina Lee, to its Board of Directors, replacing Daniel Soland, subject to ratification by shareholders at DBV’s next annual shareholder meeting. Dr. Lee also serves as a member of the Board’s Compensation Committee.
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The duration, costs and timing of clinical trials and development of our product candidates will depend on a variety of factors, many of which are outside of our control including: • the FDA’s approval of our BLA for Viaskin Peanut; • the costs of future commercialization activities, including product sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval, especially in North America; • the costs of securing manufacturing arrangements for commercial production; • revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval; • the scope, progress in, results and the costs of, our pre-clinical studies and clinical trials and other research and development programs, particularly as we seek regulatory and marketing approvals for our product candidates that successfully complete clinical trials; • the scope, prioritization and number of our research and development programs; • the costs, timing and outcome of regulatory review of our product candidates; • the achievement of milestones or occurrence of other developments that trigger payments under our existing collaboration agreements, and any additional collaboration agreements we may enter into; • the extent to which we are obligated to reimburse, or entitled to reimbursement of, clinical trial costs under any collaboration agreements or future collaborations, if any; and • the costs involved in filing, prosecuting, enforcing and defending patent claims and other intellectual property rights.
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On November 3, 2025, the Company announced the appointment of Kevin Trapp as Chief Commercial Officer, responsible for the global commercial strategy and its execution for the Viaskin Peanut patch.
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A change in the outcome of any of these variables with respect to the development and commercialization of Viaskin Peanut, if approved, or any other product candidate that we are developing could mean a significant change in the costs and timing associated with the development and commercialization of Viaskin Peanut, if approved, or such other product candidate.
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The caption Pre-Commercial Inventory of $16.1 million reflects efforts launched by the company in inventory build-up to support commercial readiness in anticipation of potential FDA approval (written down as they do not meet recognition criteria). External clinical-related expenses increased by $6.9 million, due to higher clinical trial activity driven by the initiation of patient recruitment for COMFORT Toddlers study.

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