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Item 1. Business

2026-03-26 compared with 2025-04-11 · 347 added, 291 removed, 757 unchanged (46% of the section changed)

DBV Technologies is a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin.

DBV Technologies is a late-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin.

Our therapeutic approach is based on epicutaneous immunotherapy, or EPIT, our proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin, an epicutaneous patch (i.e., a skin patch).

We have generated significant data demonstrating that Viaskin’s mechanism of action is novel and differentiated.

Viaskin targets specific antigen-presenting immune cells in the skin, called Langerhans cells, that capture the antigen and migrate to the lymph node in order to activate the immune system without passage of the antigen into the bloodstream, minimizing systemic exposure in the body.

We have generated significant data demonstrating that Viaskin patch’s mechanism of action is novel and differentiated.

Viaskin patch targets antigen-presenting immune cells in the skin, called Langerhans cells, that capture the antigen and migrate to the lymph nodes in order to activate the immune system without passage of the antigen into the bloodstream, minimizing systemic exposure in the body.

We are advancing this unique technology to treat children suffering from food allergies for whom safety is paramount since the introduction of the offending allergen into their bloodstream can cause severe or life-threatening allergic reactions, such as anaphylactic shock.

We believe Viaskin may offer convenient, , non-invasive immunotherapy to patients.

Our most advanced product candidate is Viaskin Peanut, which has been evaluated as a potential therapy for children with peanut allergy in eleven clinical trials, including four Phase 2 trials and four completed Phase 3 trials.

We also have an ongoing Phase 3 trial of Viaskin Peanut in children ages four to seven with peanut allergy, as well as one planned Phase 3 supplementary safety studies, in peanut-allergic toddlers, ages one through three.

We have earlier-stage food allergy programs including Viaskin Milk and Eosinophilic Esophagitis, or EoE.

We believe Viaskin technology may offer convenient, non-invasive immunotherapy to patients.

Our most advanced product candidate is Viaskin® Peanut Patch, which has been evaluated as a potential therapy for children with peanut allergy in twelve completed clinical trials, including five Phase 2 trials and five completed Phase 3 trials.

The Company plans a BLA submission in the first half of 2026 for Viaskin Peanut Patch as a potential treatment for children four to seven years old.

The Company also has an ongoing Phase 3 supplementary safety study of Viaskin Peanut patch in peanut-allergic toddlers ages one through three.

Conditional on successful completion of this safety study, the Company plans a BLA submission in the second half of 2026 for children ages one to three.

The Company has earlier-stage food allergy programs including Viaskin Milk and other autoimmune inflammatory diseases.

Our goal is to change the field of immunotherapy by developing and commercializing safe, effective, and convenient therapies for patients with food allergies and other immunological conditions.

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;

• 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.

Commercial Opportunity

The Company is developing launch plans, subject to FDA approval of our product candidate, that are focused on addressing the unmet needs of patients, their caregivers, physicians, and payers.

It is estimated that there are approximately 670,000 children ages 1 to 7 years old in the U.S.

with peanut allergy.

The parents and caregivers for these children are largely part of the millennials demographic which comprises 7.2 million people born between the years of 1981 and 1996.

We believe the majority of millennials turn to digital spaces for health information and advice.

If VIASKIN Peanut Patch is approved, the Company plans to launch digital and social-media campaigns to activate these parents and caregivers by encouraging shared-decision making conversations with their child’s allergist.

There are approximately 4,500 allergists in the U.S.

and anticipate that a 50 to 70 person specialty sales force can deliver in-person promotional activities to 90% of those physicians.

Market research suggests nearly 60% of peanut allergic children are cared for by allergists.

In addition, there are approximately 60,000 pediatricians that we anticipate engaging through non-personal promotion.

Finally, approximately 50 payers in the U.S.

cover 85% of insured lives and that a team of 8 to 10 account managers can be deployed to build strong managed care access.

Peanut Allergy

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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.

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.

In addition, the constant vigilance required to avoid allergen exposure can affect the quality of life of peanut-allergic children and their parents/caregivers.

Daily family activities and social events are negatively impacted by the anxiety and fear of accidental peanut ingestion.

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.

The current management of peanut allergy has significant limitations and highlights the need for safe and effective treatments that can induce clinical desensitization (i.e., increased tolerance to peanut allergen), thus minimizing the risk of reaction due to accidental ingestion.

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Several non-specific and allergen-specific treatment approaches are in various stages of clinical development for the treatment of peanut allergy.

Food allergen-specific approaches include epicutaneous immunotherapy, or EPIT, oral immunotherapy, or OIT, (both with and without adjunctive therapies), and sublingual immunotherapy, or SLIT.

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.

Food allergen-specific approaches include EPIT, oral immunotherapy (“OIT”), (both with and without adjunctive therapies), and sublingual immunotherapy (“SLIT”).

Although efficacious, peanut OIT may not be suitable or a preferred option for all children with peanut allergy because of its relatively high rate of systemic side effects and the limitations the treatment places on activities of daily living, including exercise, and unpredictability of tolerance in the setting of intercurrent illness.

A proprietary form

of OIT, Palforzia®, is approved in the US and the European Union for the treatment of peanut allergy in children aged 1–17 years.

Xolair® (omalizumab), an anti-immunoglobulin E (IgE) antibody was recently approved by the FDA for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy.

A proprietary form of OIT, Palforzia®, is approved in the US and the European Union for the treatment of peanut allergy in children aged 1–17 years.

In December 2025, Stallergenes Greer, which currently commercializes Palforzia, announced that the product will be discontinued on July 31, 2026, for business reasons.

In February 2024, Xolair® (omalizumab), an anti-immunoglobulin E (“IgE”) antibody, was approved by the FDA for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy.

SLIT for peanut allergy has demonstrated evidence of clinical success, with a more satisfactory side effect profile compared to OIT.

Despite the evident interest of clinicians to further evaluate these treatment procedures, OIT and SLIT may not be applicable across all ages and risk categories of peanut-allergic children and adults.

There remains an unmet need for additional therapies for patients with peanut allergy.

Following its acquisition of RAPT Therapeutics in March 2026, GlaxoSmithKline (“GSK”) is developing ozureprubart, an IgE‑pathway inhibitor with potential relevance for food‑allergy treatment.

With a Phase IIb readout expected in 2027 and Phase 3 trials planned thereafter, ozureprubart could emerge as a competitor in segments characterized by persistent unmet 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.

For example, in the case of respiratory allergies, symptomatic and maintenance allergy treatments, such as antihistamines, bronchodilators and corticosteroids, are available and all among the most widely used treatments in the world.

Our Viaskin Technology Platform

Over the last decade, we have developed an innovative immunotherapy technology platform, with the potential for sustained therapeutic effect, by delivering biologically active compounds, including antigens, via intact skin.

Epicutaneous, also known as on the skin, immunotherapy, or EPIT, exposes tolerance-promoting immune cells in the skin to an adhesive dermal patch containing a small (micrograms) dose of antigen, such as food protein.

This technology platform, which we call Viaskin, is an innovative approach to potentially treating immunological disorders, with a primary focus on food allergy.

Over the last few decades, we have developed an innovative immunotherapy technology platform, with the potential for sustained therapeutic effect, by delivering biologically active compounds, including antigens, via intact skin.

Epicutaneous, also known as on the skin, immunotherapy, or EPIT, exposes tolerance-promoting immune cells in the skin to an adhesive patch containing a small (micrograms) dose of antigen, such as food protein.

This technology platform, called Viaskin, is an innovative approach to potentially treating immunological disorders, with a primary focus on food allergy.

In EPIT, intact skin is exposed to allergen via the Viaskin technology using a patch that contains microgram amounts of food protein.

Allergen applied via EPIT is captured in the superficial layers of the skin by specialized antigen-presenting cells (Langerhans cells within the epidermis), as well as dermal dendritic cells, thus limiting exposure to the bloodstream.

In experimental models, EPIT induced a population of regulatory T cells, or Tregs, with specific properties that resulted in suppression of allergic.

symptoms and protection against further sensitizations.

EPIT-induced epigenetic modifications favored a Treg-mediated immune response and a downregulated Th2 response and may play a role in the sustainability of effect.

In experimental models, EPIT induced a population of regulatory T cells (“Tregs”) with specific properties that resulted in suppression of allergic symptoms and protection against further sensitizations.

EPIT-induced epigenetic modifications favored a Treg-mediated immune response and a down regulated Th2 response and may play a role in the sustainability of effect.

Based on our trials and research, we believe that EPIT has the potential to provide the intended benefits of a disease-modifying treatment in allergy, while avoiding severe or life-threatening allergic reactions.

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• Containing a dry layer of allergen in its center, the patch is positioned on intact skin, without prior preparation.

• The condensation chamber formed between the skin and the center of the patch creates hyperhydration of the skin and an accumulation of water.

• The accumulation of water solubilizes the allergen.

Due to this condensation chamber, the epidermis becomes more permeable allowing passage of the allergen into the epidermis.

• The occlusion chamber formed between the skin and the center of the patch promotes an accumulation of water.

• The accumulation of water solubilizes the allergen and allows its passage into the epidermis.

Once in the epidermis, the allergen is captured by a population of highly specialized cells:

Langerhans cells.

These cells can capture the protein at the surface of the skin, process it and present its epitopes to the T-lymphocytes in the lymph nodes.

These cells can capture the allergen at the surface of the skin, process it and migrate to the local lymph nodes to present allergen fragments to T-lymphocytes.

Langerhans cells in the epidermis capturing peanut allergen (depicted in green) within the stratum corneum (the outermost layer of the skin) following solubilization of allergen and permeation into the skin after Viaskin patch application.

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The following table summarizes the current development status of our product candidates:

Program and Indication Trial Phase 2 Phase 3

VIAKSKIN® Peanut Patch

Program and Indication Trials Phase 2 Phase 3

VIASKIN® Peanut Patch

(DBV712) - Peanut Allergy

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Ages 4-7 years

→ OLE extension is on-going

Ages 1-3 years

OLE extension to EPITOPE (Year 2 of OLE completed)

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Viaskin Peanut for Children ages 1-3

We are developing Viaskin Peanut for the treatment of peanut allergy in toddlers one to three years of age, given the high unmet need and absence of approved treatments for this population.

We are developing Viaskin Peanut for the treatment of peanut allergy in toddlers one to three years of age, given the high unmet need and the limited number of approved treatments for this population.

This program is independent from the Viaskin Peanut Program in 4-7-year-olds and uses the cVP (original patch).

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p<0.001, right hand side chart).

ED ≥ 1,000 mg

Treatment Responders ✝

† Responder definition = If eliciting dose (ED) ≤10 mg at baseline, a subject is deemed a responder if ED ≥300 mg at M12.

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As stated in an accompanying editorial piece, these data are seen as “very good news” for toddlers with peanut allergy, as there are currently no approved treatment options for peanut-allergic children under the age of 4 years.

Interim Results from Open-label Extension to EPITOPE Study (EPOPEX)

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.

This ongoing, open label extension to EPITOPE is known as EPOPEX and is evaluating the long-term clinical benefit of Viaskin Peanut in subjects who completed the Phase 3 EPITOPE trial.

Subjects randomized to active treatment in EPITOPE could receive an additional two-years of treatment in the OLE and subjects randomized to placebo in EPITOPE cross-over to receive three years of active treatment with annual double-blind placebo-controlled food challenges (DBPCFC) and safety assessments.

This ongoing, OLE to EPITOPE is known as EPOPEX and is evaluating the long-term clinical benefit of Viaskin Peanut in subjects who completed the Phase 3 EPITOPE trial.

266 eligible EPITOPE participants enrolled in EPOPEX.

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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;

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.

Furthermore, following an additional year of treatment, 55.9% completed the food challenge without meeting the stopping criteria (i.e., consumed the equivalent of about 12-14 peanuts).

Treatment Responders ✝

*ED ≥ 1,000 mg Completed DBPCFC without Meeting Stopping Criteria

◦ Number of subjects with non-missing food challenge endpoint

Greenhawt et al.

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Local application site reactions continued to be the most reported adverse event, with frequency decreasing during the second year of treatment.

The frequency of treatment related TEAEs also decreased in Year 2 relative to Year 1.

The frequency of treatment related treatment-emergent advese events (“TEAEs”) also decreased in Year 2 relative to Year 1.

There were no treatment related serious TEAEs reported during the second year of treatment (versus 1% in EPITOPE).

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Finally, no treatment-related anaphylactic events were observed in the second year of treatment (compared with 1.7% of participants during the first year of treatment with Viaskin Peanut in EPITOPE).

In summary, two years

of VP250 in 1-3-year-old peanut-allergic toddlers resulted in continued increases in treatment effect, beyond those observed after one year, without any new safety signals.

In summary, two years of VP250 in 1-3-year-old peanut-allergic toddlers resulted in continued increases in treatment effect, beyond those observed after one year, without any new safety signals.

In placebo-treated EPITOPE participants, outcomes after 12 months of cross-over to Viaskin Peanut in EPOPEX were consistent with EPITOPE treatment results:

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n=62 placebo).

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).

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;

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The FDA did not request an additional efficacy study in 1-3-year-olds (i.e., the Agency agreed that the primary endpoint was satisfactorily met in DBV’s Phase 3 trial EPITOPE).

There was agreement with the FDA to conduct a supplemental safety study (COMFORT Toddlers) using the original square (cVP) Viaskin Peanut patch to augment the safety data collected from EPITOPE and have close to 600 total subjects on active treatment in the controlled safety database.

There was agreement with the FDA to conduct a supplemental safety study using the original square (“cVP”) Viaskin Peanut patch to augment the safety data collected from EPITOPE and have close to 600 total subjects on active treatment in the controlled safety database (“COMFORT Toddlers”).

On November 9, 2023, the Company submitted the protocol for its COMFORT Toddlers supplemental safety study in 1 – 3 years-old to FDA.

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DBV has agreed to guidance provided by the FDA on a potential pathway under the Accelerated Approval Program for the Viaskin Peanut patch in toddlers ages 1 – 3 years-old.

FDA guidance for Accelerated Approval include three qualifying criteria:

1) that the product candidate treats a serious condition, 2) that the product candidate generally provides a meaningful advantage over available therapies, and 3) that the product candidate demonstrates an effect on an intermediate clinical endpoint that is reasonably likely to predict clinical benefit.

FDA confirmed that the Company has met criterion 1 and 2.

FDA confirmed that the Company has met Accelerated Approval qualifying criteria 1 and 2.

Regarding criterion 3, FDA has provided guidance and suggestion regarding the intermediate clinical endpoint, which the Company has agreed to in informal discussions with the FDA.

The Company intends to formalize the Accelerated Approval guidance provided by FDA via submission of a meeting request to confirm the general elements of the two study components:

The Company formalized the Accelerated Approval guidance provided by FDA via submission of a meeting request and confirmed the general elements of the two study components:

the COMFORT Toddlers safety study, to be completed before BLA submission, and the confirmatory effectiveness study, including the third Accelerated Approval criterion regarding the intermediate clinical endpoint.

The Company expects that the confirmatory study will be initiated by the time of BLA submission and would run in parallel to commercialization in the United States, if 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 announced further that it has aligned with FDA on a wear time collection methodology in COMFORT Toddlers that provides a practical approach for subjects and families, is intended to generate sufficient data to support a BLA submission, and places wear time into an acceptable clinical hierarchy relative to other study endpoints.

DBV has initiated study start-up activities and plans to screen the first subject in the second quarter of 2025.

The company anticipates enrolling approximately 300 – 350 subjects on active treatment into the safety study, which would bring the total Viaskin Peanut patch safety database in toddlers to approximately 600 subjects, consistent with prior FDA guidance.

On June 25, 2025, the Company announced that the first subject was screened in COMFORT Toddlers supplemental safety study in peanut allergic toddlers 1 – 3 years old.

The Company anticipates enrolling approximately 300 – 350 subjects on active treatment into the COMFORT Toddlers safety study, which would bring the total Viaskin Peanut patch safety database in toddlers to approximately 600 subjects, consistent with prior FDA guidance.

With this path forward, the BLA submission for Viaskin Peanut patch in 1 – 3 years-old under the Accelerated Approval program is anticipated to be supported by:

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On March 7, 2023, the Company announced that the first patient was screened in the VITESSE trial.

The Company announced on September 23, 2024 that subject screening was completed in the third quarter of 2024.

Topline results are anticipated in the fourth quarter of 2025.

The Company announced on September 23, 2024 that subject screening has been completed in the third quarter of 2024.

We enrolled a total of 654 subjects for participation in the VITESSE study, randomized 2:1 active to placebo.

The primary efficacy endpoint is the percentage of treatment responders in the active versus placebo arms at month 12.

The primary efficacy analysis includes the success criterion of the lower bound of the confidence interval of the difference in responder rates between active and placebo groups being greater than or equal to 15%.

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 double-blind, placebo-controlled food challenge (DBPCFC) will be administered at baseline and month 12 to determine a subject’s ED at both timepoints.

The primary efficacy analysis was the success criterion of the lower bound of the confidence interval of the difference in responder rates between active and placebo groups being greater than or equal to 15%.

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.

A DBPCFC will be administered at baseline and month 12 to determine a subject’s ED at both timepoints.

We defined the peanut protein sensitivity inclusion criteria to align with peanut allergy patients at the greatest risk of experiencing reactions to accidental peanut ingestion and with the highest unmet need.

We added a 600 mg dose of peanut protein to the month 12 DBPCFC to increase the sensitivity of the efficacy assessment.

Participants will apply the modified patch (either Viaskin Peanut 250 μg or a placebo) daily for a period of 12 months.

The maximum study duration per subject is 58 weeks:

Participants applied the modified patch (either Viaskin Peanut 250 μg or a placebo) daily for a period of 12 months.

The maximum study duration per subject was 58 weeks:

a four-week screening period, a 12-month treatment period and a two-week follow-up period.

During the screening period, subjects will undergo an initial screening visit with assessment for eligibility according to peanut skin prick test (SPT) and serum peanut IgE.

Those meeting these criteria will proceed to a peanut DBPCFC to confirm their peanut allergy and establish an entry peanut ED.

The entry DBPCFC will be 1 mg peanut protein, and will escalate up to a highest single dose of 100 mg peanut protein.

Subjects who react with an ED at or below the dose of 100 mg peanut protein are considered eligible.

At month 12, a post-treatment DBPCFC will be performed, with a starting dose of 3 mg peanut protein, escalating to a highest dose of 1,000 mg peanut protein according to the following schedule:

During the screening period, subjects underwent an initial screening visit with assessment for eligibility according to peanut skin prick test (“SPT”) and serum peanut IgE.

Those meeting these criteria proceeded to a peanut DBPCFC to confirm their peanut allergy and establish an entry peanut ED.

The entry DBPCFC was 1 mg peanut protein, and was escalated up to a highest single dose of 100 mg peanut protein.

Subjects who reacted with an ED at or below the dose of 100 mg peanut protein were considered eligible.

At month 12, a post-treatment DBPCFC was performed, with a starting dose of 3 mg peanut protein, escalating to a highest dose of 1,000 mg peanut protein according to the following schedule:

3, 10, 30, 100, 300, 600, 1,000 mg.

Secondary efficacy endpoints include changes in Cumulative Reactive Dose, ED and severity of allergic reaction at baseline and month 12 food challenge.

VITESSE will also evaluate the safety of the modified Viaskin Peanut patch based on overall adverse events, local site reactions and systemic allergic reactions.

The VITESSE Instructions for Use (IFU) will direct caregivers to apply one patch at approximately the same time each day, following removal of the previous day’s patch.

The updated IFU now outlines that Viaskin Peanut 250 μg is to be worn for as close to a full day as possible (i.e., 24 hours) with a minimum daily wear time of 20 hours each day.

Patch adhesion will be assessed in VITESSE to affirm the modified Viaskin Peanut patch performs adequately, which aligns with existing regulatory requirements for patch-based therapies.

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.

Secondary efficacy endpoints included changes in Cumulative Reactive Dose, ED and severity of allergic reaction at baseline and month 12 food challenge.

VITESSE also evaluated the safety of the modified Viaskin Peanut patch based on overall adverse events, local site reactions and systemic allergic reactions.

The VITESSE Instructions for Use (“IFU”) directed caregivers to apply one patch at approximately the same time each day, following removal of the previous day’s patch.

The updated IFU outlines that Viaskin Peanut 250 μg is to be worn for as close to a full day as possible (i.e., 24 hours) with a minimum daily wear time of 20 hours each day.

Patch adhesion was assessed in VITESSE to affirm the modified Viaskin Peanut patch performs adequately, which aligns with existing regulatory requirements for patch-based therapies.

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.

On December 16, 2025, the Company announced the positive topline results from the VITESSE study and that its primary endpoint was met.

In VITESSE, Viaskin Peanut patch demonstrated a statistically significant treatment effect (p<0.001), with 46.6% of children in the Viaskin Peanut patch arm meeting the treatment responder criteria after 12 months, as compared to 14.8% of children in the placebo arm (difference in response rates = 31.8%;

95% CI = (24.5, 39.0%)), exceeding the lower bound prespecified threshold of 15%.

Safety results were consistent with the safety profile of the Viaskin Peanut clinical program to date.

The most common TEAEs observed during the VITESSE study were mild-to-moderate local skin reactions at the patch application site.

Discontinuations due to TEAEs were low at 3.2% in the treatment arm compared to 0.5% of in the placebo arm.

Notably, there were no reports of treatment-related serious adverse events and treatment-related anaphylaxis was low at 0.5% (n=2) and both children continued treatment.

The data from the exploratory adhesion assessments were in line with the Company’s expectations.

Overall, compliance was high at 96.2%, consistent with what has been observed in other Phase 3 Viaskin Peanut studies.

The Company is currently conducting the open-label extension phase of the VITESSE study.

Following the 12-month double-blind period, participants were given the option to continue into an open-label extension of VITESSE in which all participants receive Viaskin Peanut patch for up to a total of three years on treatment.

VITESSE Primary Endpoint :

Percentage of Treatment Responders at M12 (ITT)

Viaskin Peanut for children ages 4-11

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In the PEOPLE trial, patients who were randomized and received active treatment during PEPITES received Viaskin Peanut 250 μg for up to four additional years, while patients who received placebo during PEPITES were treated with Viaskin Peanut 250 μg for up to five years.

The results from PEPITES and REALISE formed the basis for our 2019 regulatory submission in the United States, a Biologics License Application, or BLA, for the use of Viaskin Peanut in peanut-allergic patients four to 11 years of age.

The results from PEPITES, REALISE and PEOPLE formed the basis for our 2020 regulatory submission in the European Union, a Marketing Authorization Application, or MAA, for the use of Viaskin Peanut in peanut-allergic patients four to 11 years of age.

The results from PEPITES and REALISE formed the basis for our 2019 regulatory submission in the United States, a BLA for the use of Viaskin Peanut in peanut-allergic patients four to 11 years of age.

The results from PEPITES, REALISE and PEOPLE formed the basis for our 2020 regulatory submission in the European Union, a Marketing Authorization Application (“MAA”) for the use of Viaskin Peanut in peanut-allergic patients four to 11 years of age.

PEPITES (Peanut EPIT Efficacy and Safety Study)

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A new patch was applied each day, and after two weeks, each patch was worn for 24 hours, plus-or-minus 4 hours.

During the trial, patients’ sensitivity to peanut protein was assessed using a double-blind, placebo-controlled food challenge, or DBPCFC, at baseline and again after 12 months of treatment.

The DBPCFC was halted once the patient exhibited an objective symptom, as described on a pre-specified scale, thus establishing a subject’s peanut reactivity level, also known as the patient’s eliciting dose, or ED.

During the trial, patients’ sensitivity to peanut protein was assessed using a DBPCFC at baseline and again after 12 months of treatment.

The median baseline reactive dose in PEPITES was 100 mg at baseline.

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For patients with a baseline ED greater than 10 mg but less than or equal to 300 mg, a responder was defined as a patient with a peanut protein ED equal to or greater than 1,000 mg of peanut protein after 12 months of treatment.

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.

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.

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A difference in the CRD was observed between Viaskin Peanut and placebo (nominal p-value <0.001) following 12 months of treatment.

Response Rate (ITT) after 12 Months

CRD after 12 months

Exploratory analyses showed that changes in peanut-specific biomarkers, including immunoglobulin E (IgE), and immunoglobulin G4(IgG4), support the immunomodulatory effect of Viaskin Peanut.

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.

Exploratory analyses showed that changes in peanut-specific biomarkers, including IgE, and immunoglobulin G4 (“IgG4”), support the immunomodulatory effect of Viaskin Peanut.

9.8 kUA/L) and month 6 (27.4 kUA/L vs.

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PEPITES Immunological Responses

IQR =interquartile range ;

PS =peanut-specific ;

VP =Viaskin Peanut.

Fleischer DM, et al.JAMA.

doi :10.1001/jama 2019.1113.

DBV Technologies, Data on File.

February 2019.

In a post-hoc analysis, the majority of subjects on Viaskin Peanut exhibited an increased ED compared to the placebo group (62.6% in active vs.

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Based on this analysis, we believe that increasing the ED should translate to a reduction in the risk of reaction to accidental peanut exposures, as it will take a higher ingestion quantity to trigger a reaction.

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%.

Change in Eliciting Dose after 12 months

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Treatment adherence was high (98.5%), and similar discontinuation rates between treatment groups were reported, with 89.9% of subjects completing the trial.

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.

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.

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Six of these ten cases were treated with epinephrine, and five of the eight subjects continued on Viaskin Peanut in the trial.

Following the completion of PEPITES, all eligible subjects were invited to enroll in PEOPLE ( Open-Label Follow-Up Study of the PEPITES Study to Evaluate the Long-term Efficacy and Safety of Viaskin Peanut ), a long-term, open-label extension trial of Peanut 250 μg in children.

In the PEOPLE trial, subjects who were randomized and received active treatment during PEPITES received Viaskin Peanut 250 μg for two additional years, while subjects who previously received placebo during PEPITES were treated with Viaskin Peanut 250 μg for three years.

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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 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.

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.

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.

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 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.

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In addition, 13.5% (19/141) of subjects completed the food challenge without meeting stopping criteria at 36 months (cumulative dose of 5,444 mg).

At month 36, the mean cumulative reactive dose (CRD) was 1,768.8 mg (median 944 mg) compared to 223.8 mg (median 144 mg) at baseline.

At month 36, the mean CRD was 1,768.8 mg (median 944 mg) compared to 223.8 mg (median 144 mg) at baseline.

% of Subjects (N=141)

Changes in ED were maintained or improved over three years in the majority of subjects in the Open-label extension study (Fleischer DM, et al.

Changes in ED were maintained or improved over three years in the majority of subjects in the OLE study (Fleischer DM, et al.

J Allergy Clin Immunol .

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Subjects in the clinical trial were selected, as per clinical practice, based on a well-documented medical history of IgE-mediated reactions to peanut, including children with a history of severe anaphylaxis, along with skin and serum test results highly predictive of peanut allergy.

As no DBPCFCs were required, the primary endpoint of the clinical trial was safety as measured by adverse events, treatment-emergent adverse events and serious adverse events after six months of blinded treatment.

As no DBPCFCs were required, the primary endpoint of the clinical trial was safety as measured by adverse events, TEAEs and SAEs after six months of blinded treatment.

Secondary endpoints included evolution of peanut-specific serological markers over time, including IgE, IgG and skin prick test wheal.

Exploratory criteria also included scores from subjects’ Food Allergy Quality of Life Questionnaire, or FAQLQ, and the Food Allergy Independent Measure, FAIM.

Exploratory criteria also included scores from subjects’ Food Allergy Quality of Life Questionnaire (“FAQLQ”) and the Food Allergy Independent Measure (“FAIM”).

In March 2017, we announced the completion of enrollment in REALISE, which randomized 393 subjects in 32 centers across North America.

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The mean participant compliance was above 95%.

In November 2021, long-term results of from REALISE, including the safety of Viaskin Peanut over three years and potential impact on health-related quality of life (HRQL), were presented at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting.

In November 2021, long-term results of from REALISE, including the safety of Viaskin Peanut over three years and potential impact on health-related quality of life (“HRQL”), were presented at the ACAAI Annual Scientific Meeting.

United States Regulatory History

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In August 2020, the Company received a Complete Response Letter (“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 patch-site adhesion on efficacy and indicated the need for patch modifications, followed by completion of a new human factors study.

In addition, the FDA indicated that supplementary clinical data would need to be generated to support the modified patch.

Finally, the FDA requested additional Chemistry, Manufacturing and Controls (“CMC”) data.

The FDA did not raise any safety concerns related to Viaskin Peanut.

The FDA requested additional Chemistry, Manufacturing and Controls (“CMC”) data, but the FDA did not raise any safety concerns related to Viaskin Peanut.

In January 2021, the Company received written responses from the FDA to questions provided in the Type A meeting request that the Company submitted in October 2020 following receipt of the CRL.

The FDA agreed with the Company’s position that a modified Viaskin Peanut patch should not be considered as a new product entity provided the occlusion chamber of the current Viaskin Peanut patch and the peanut protein dose of 250 µg (approximately 1/1000 of one peanut) remains unchanged and performs in the same way it has performed previously.

In March 2021, the Company commenced CHAMP (Comparison of adHesion Among Modified Patches), a Phase 1 trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches to confirm consistency of efficacy data between the existing and modified patches.

The study was completed in the second quarter of 2021 and the Company selected the circular patch for further development, which is larger in size relative to the current patch and circular in shape.

In May 2021, the Company submitted a proposed protocol to the FDA for STAMP (Safety, Tolerability, and Adhesion of Modified Patches), a 6-month safety and adhesion study.

On October 14, 2021, in an Advice/Information Request letter, the FDA requested the Company conduct a stepwise, or sequential, approach to the modified Viaskin patch development program by conducting allergen uptake comparison studies (i.e., ‘EQUAL in Adults’, EQUAL) and submitting the data for FDA review and feedback prior to starting the STAMP study.

After careful review of the FDA’s information requests, the Company decided not to pursue the approach to the development plans for Viaskin Peanut as requested by the FDA.

The Company estimated that the FDA’s proposed sequential approach would require at least five rounds of exchanges with the FDA to achieve alignment before initiating STAMP, the 6-month safety and adhesion study.

As such, in December 2021, the Company announced its plan to initiate a pivotal Phase 3 placebo-controlled efficacy trial for a modified Viaskin Peanut patch (mVP) in children in the intended patient population.

The Company considered this approach the most straightforward to potentially demonstrate effectiveness, safety, and improved in vivo adhesion of the mVP.

Following written exchanges with the FDA, the FDA confirmed it was aligned with the Company’s change in strategy.

In March 2021, the Company commenced CHAMP (Comparison of adHesion Among Modified Patches), a Phase 1 trial in healthy adult volunteers.

In May 2021, the Company submitted a proposed protocol to the FDA for STAMP (Safety, Tolerability, and Adhesion of Modified Patches), a 6-month safety and adhesion study which was to be conducted concurrently with DBV’s allergen uptake comparison studies (i.e., ‘EQUAL in Adults’, EQUAL).

On October 14, 2021, in an Advice/Information Request letter, the FDA requested the Company conduct a stepwise, or sequential, approach to the modified Viaskin patch development program by conducting EQUAL first and submitting the data for FDA review and feedback prior to starting the STAMP study.

In December 2021, the Company decided not to pursue the sequential approach requested by the FDA and instead announced its plan to initiate a pivotal Phase 3 placebo-controlled efficacy trial for mVP in children in the intended patient population.

Following written exchanges with the FDA, the FDA confirmed it had been aligned with the Company’s strategy.

On September 7, 2022, the Company announced the initiation of VITESSE, a Phase 3 pivotal study of the mVP in children ages 4-7 years with peanut allergy.

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On December 23, 2022, the Company announced that the FDA lifted the partial clinical hold.

The FDA confirmed the Company satisfactorily addressed all clinical hold issues and the VITESSE phase 3 clinical study could proceed with the revised trial protocol.

On March 7, 2023, the Company announced that the first patient was screened in the VITESSE study.

The Company announced on September 23, 2024 that subject screening was completed in the third quarter of 2024.

Topline results are anticipated in the fourth quarter of 2025.

In June 2022, the Company announced positive topline results from Part B of EPITOPE, which enrolled 362 subjects ages 1-3 years, of which 244 and 118 were in the active and placebo arms respectively.

Enrollment was balanced for age and baseline disease characteristics between the active and placebo treatment arms.

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.

The Company announced the positive topline results from the VITESSE study on December 16, 2025.

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.

The FDA required additional safety data to augment the safety data collected from EPITOPE in support of a BLA.

On July 31, 2023, the Company announced receipt of feedback from FDA on two supplemental safety studies, COMFORT Children and COMFORT Toddlers.

On November 9, 2023, the Company submitted the protocol for its COMFORT Toddlers supplemental safety study in 1 – 3 years-old to FDA.

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On July 30, 2024, the Company announced that it and the FDA had been engaged in ongoing dialogue since May 2023 on the COMFORT Toddlers supplemental safety study in 1 – 3 years-old with a peanut allergy.

Since March 2024, much of the dialogue between DBV and FDA regarding the COMFORT Toddlers supplemental study had focused on patch wear-time experience, including how prescribers would advise parents and caregivers to manage day-to-day variability in patch wear time.

The Company proposed an approach, informed by the EPITOPE efficacy data, that focuses on the user experience during the first 90-days of treatment.

The Company submitted to the FDA draft labeling for Section 2 – Dosing and Administration, for a potential Viaskin Peanut Prescribing Information (PI), along with comprehensive supportive data and analyses.

Within the first 90-days of treatment (excluding the lead-in dosing period) it is possible to identify those patients who are likely to have a robust clinical efficacy response based on patch wear time experience (i.e., “Label-in” patients).

The proposed PI recommends continuation of treatment for these patients.

With the same 90-day approach, patients less likely to have a robust clinical efficacy response,

identified by their patch wear-time experience, would be identified as “Label-out” patients.

In these instances, the PI would recommend a shared decision-making process, between the health care provider and the parent or caregiver, to determine whether treatment should be discontinued.

The Company also announced on November 9, 2023, 2-year results from the ongoing phase 3 open-label extension to the EPITOPE trial, EPOPEX, of Viaskin Peanut in toddlers.

On October 22, 2024, the Company announced positive regulatory updates for the Viaskin Peanut patch in the United States and Europe.

DBV has agreed to guidance provided by the FDA on a potential pathway under the Accelerated Approval Program for the Viaskin Peanut patch in toddlers ages 1 – 3 years-old.

FDA guidance for Accelerated Approval include three qualifying criteria:

FDA confirmed that the Company has met criterion 1 and 2.

Regarding criterion 3, FDA has provided guidance and suggestion regarding the intermediate clinical endpoint, which the Company has agreed to in informal discussions with the FDA.

The Company intends to formalize the Accelerated Approval guidance provided by FDA via submission of a meeting request to confirm the general elements of the two study components:

DBV had agreed to guidance provided by the FDA on a potential pathway under the Accelerated Approval Program for the Viaskin Peanut patch in toddlers ages 1 – 3 years-old.

FDA confirmed that the Company met Accelerated Approval qualifying criterion 1 and 2.

Regarding criterion 3, FDA provided guidance and suggestion regarding the intermediate clinical endpoint, which the Company agreed to in informal discussions with the FDA.

The Company formalized the Accelerated Approval guidance provided by FDA via submission of a meeting request and confirmed the general elements of the two study components:

The 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.

DBV has initiated study start-up activities and plans to screen the first subject in the second quarter of 2025.

The Company announced further that it aligned with FDA on a wear time collection methodology in COMFORT Toddlers intended to generate sufficient data to support a BLA submission.

On June 25, 2025, the Company announced that the first subject was screened in the COMFORT Toddlers supplemental safety study in peanut allergic toddlers 1-3 years old.

The Company anticipates enrolling approximately 300 – 350 subjects on active treatment into the safety study, which would bring the total Viaskin Peanut patch safety database in toddlers to approximately 600 subjects, consistent with prior FDA guidance.

With this path forward, the BLA submission for Viaskin Peanut patch in 1 – 3 years-old under the Accelerated Approval program is anticipated to be supported by:

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:

Positive efficacy and safety data from DBV’s previously completed EPITOPE Phase 3 Study;

Additional safety data generated in COMFORT Toddlers supplemental safety study to be initiated in the second quarter of 2025.

The Company submitted the protocol for its COMFORT Children supplemental safety study in ages 4-through-7-years-old to the FDA on November 29, 2023.

On October 22, 2024, the Company announced further that the COMFORT Children safety study is expected to be initiated in the second quarter of 2025.

On March 24, 2025, the Company announced that in a Written Responses Only to the Company’s Type D IND meeting request the FDA agreed with the Company’s proposal that the safety exposure data from the VITESSE Phase 3 study for Viaskin peanut patch in 4 – 7-year-olds will be sufficient to support a BLA filing in this age group.

As a result, the COMFORT Children supplemental safety study will no longer be required and the Company will not conduct the study.

The Company will utilize the safety data from the VITESSE participants randomized to active treatment as well as placebo-crossover participants in the VITESSE Open Label Extension (OLE).

Accordingly, the Company plans to submit a BLA in the first half of 2026 and anticipates potentially accelerating the product launch by approximately one year, subject to FDA approval.

On December 11, 2024, the Company announced that it reached alignment with FDA on the Accelerated Approval pathway for Viaskin Peanut patch in toddlers 1-3 years-old and on key study design elements for the COMFORT Toddlers study, including study size and wear time collection methodology and analysis.

The Company announced further that FDA confirmed criteria for a post-marketing confirmatory study in toddlers 1-3 years-old and that the Company and FDA agreed that the confirmatory study will assess the effectiveness of the intended commercial Viaskin Peanut patch and will need to be initiated at the time that the BLA is submitted.

The confirmatory study will include a double-blind, placebo-controlled food challenge (DBPCFC) and will use the same statistical criteria for success (i.e., lower bound of the 95% CI > 15%) as used in the EPITOPE Phase 3 efficacy study.

Adhesion data for the post-marketing confirmatory study will be collected in a similar manner relative to the COMFORT Toddlers study.

The Company expects these data will further support the importance of average daily wear time in the use of the Viaskin Peanut patch as it relates to efficacy and labeling.

The Company submitted the protocol for its COMFORT Children supplemental safety study in ages 4-through-7-years-old to the FDA on November 29, 2023.

On March 24, 2025, the Company announced that in a Written Responses Only to the Company’s Type D investigational new drug (“IND”) meeting request the FDA agreed with the Company’s proposal that the safety exposure data from the VITESSE Phase 3 study for the Viaskin Peanut patch in 4-7-year-olds will be sufficient to support a BLA filing in this age group.

As a result, the COMFORT Children supplemental safety study is no longer required and the Company will not conduct the study.

The Company will utilize safety data from VITESSE participants randomized to active treatment as well as placebo-crossover participants in the VITESSE OLE study.

Accordingly, the Company plans to submit a BLA for the Viaskin Peanut patch in 4-7 year-olds in the first half of 2026 and anticipates potentially accelerating the product launch by approximately one year, subject to FDA approval.

European Union Regulatory History

In November 2020, we announced that our Marketing Authorization Application, or MAA, for Viaskin Peanut, submitted under the name “Abylqis®”, had been validated by the European Medicines Agency, or EMA.

The validation of the MAA confirmed that the submission was sufficiently complete to begin the formal review process for Viaskin Peanut to treat peanut allergies in children ages four to 11 years.

Following the MAA validation, the EMA’s Committee for Medicinal Products for Human Use, or CHMP, reviews the application and provides a recommendation to the European Commission, on whether to grant a marketing authorization.

On August 2, 2021, we announced we had received from the EMA the Day 180 list of outstanding issues, which is an established part of the prescribed EMA review process.

It is a letter that is meant to include any remaining questions or objections at that stage in the process.

The EMA identified one major objection remained at Day 180.

The Major Objection questioned the limitations of the data, for example, the clinical relevance and effect size supported by a single pivotal study.

In November 2020, we announced that our MAA for Viaskin Peanut, submitted under the name “Abylqis®”, had been validated by the European Medicines Agency (“EMA”).

The validation of the MAA confirmed that the submission was sufficiently complete to begin the formal review process.

On August 2, 2021, the Company announced it had received from the EMA the Day 180 list of outstanding issues, which is an established part of the prescribed EMA review process, which identified one Major Objection remained at Day 180 questioning the limitations of the data, for example, the clinical relevance and effect size supported by a single pivotal study.

On December 17, 2021, we announced we had withdrawn the MAA for Viaskin Peanut, submitted under the name “Abylqis”, and formally notified the EMA of our decision.

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.

Previous advice obtained from two local country regulatory health authorities indicated a potential path for a 1 – 7 year-old registration with one patch, the modified patch.

The EMA recently confirmed through scientific advice that the completed EPITOPE study in 1 – 3 years-old, and a positive VITESSE study in 4 – 7 years-old, could constitute an MAA submission for a 1 – 7 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.

Timing for the initiation of this new safety study to satisfy the important EU market is currently being planned.

The Company intends to resubmit the MAA when that data set is available.

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.

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.

The MILES (Milk Efficacy and Safety) clinical trial was designed to determine a safe and effective dose in two age groups:

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.

The MILES clinical trial was designed to determine a safe and effective dose in two age groups:

children ages 2 to 11 and adolescents ages 12 to 17.

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In February 2018, we announced topline results from Part B of the MILES study.

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).

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.

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In addition to our development programs in food allergies, we have also explored the use of our Viaskin technology for the treatment of inflammatory and autoimmune diseases with high unmet medical need.

Human proof-of-concept trials have been conducted with Viaskin in EoE and as a booster vaccination against Bordetella pertussis, or whooping cough, in healthy adults.

Our other earlier stage research programs have included vaccination for respiratory syncytial virus (RSV), as well as potential treatments for inflammatory bowel disease (IBD), celiac disease and type I diabetes.

Diagnostic Tool Development

Human proof-of-concept trials have been conducted with Viaskin in eosinophilic esophagitis (“EoE”) and as a booster vaccination against Bordetella pertussis, or whooping cough, in healthy adults.

Our other earlier stage research programs include, in particular, celiac disease.

In May 2016, we entered into a Development Collaboration and License Agreement (the “Collaboration Agreement”) with Société des Produits Nestlé S.A.

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Potential Biomarker Applications

We are continuing to explore other cellular mechanisms modulated by EPIT, such as biomarkers, in collaboration with external companies and academic institutions in both the United States and EU.

We believe that with improved knowledge about the evolution of immunological biomarkers and epigenetic modulation, we may be able to determine the level of patient response earlier during treatment, ensure follow-up and measure tolerance maintained once treatment is completed.

At the 2016 EAACI meeting in Vienna, Austria, we presented initial findings from some of these collaborations, which suggest that proprietary biomarker modeling may be used to help monitor patient responses to Viaskin Peanut.

Additional research is planned to further strengthen the results of these early findings.

We continue to investigate the cellular and molecular mechanisms associated with EPIT, with a particular focus on identifying immunologic biomarkers that may be used to monitor patients’ response to Viaskin Peanut.

This work is conducted in collaboration with external partners and academic institutions across the United States and EU, and includes the evaluation of serologic (i.e., peanut-specific antibodies) and cellular (e.g., basophil activation) immune parameters, as well as epigenetic modifications, across our clinical development program.

As our understanding of the immunologic evolution and epigenetic changes associated with EPIT advances, we believe this research may enable earlier identification of patients who are responding to treatment.

Such insights may inform clinical decision-making, support longitudinal clinical follow-up, and assist in evaluating the durability of desensitization following treatment completion.

We have presented and published selected findings from these efforts.

At the 2016 EAACI Annual Congress, we reported exploratory analyses of serum biomarkers from in children enrolled in the Phase IIb VIPES trial and its open-label extension.

These analyses suggested that a proprietary algorithm integrating selected immunologic variables, including peanut-specific IgE and IgG4, as well as component-resolved measurements, may help monitor patient responses to Viaskin Peanut.

Subsequent analyses of serum biomarkers from the Phase 3 PEPITES trial, published in Allergy (Bastin et al., 2023), further characterized the longitudinal evolution of immune parameters.

Findings suggested that combining certain serologic markers, including peanut-specific IgG4/sIgE ratios and component-resolved diagnostics (Ara h 1 sIgE), demonstrated moderate discriminative capacity in differentiating clinical responder status after 12 months of treatment.

Additional research is planned to further characterize and validate immunologic, cellular, and molecular parameters that may correlate with treatment response.

These efforts aim to determine whether such biomarkers, alone or in combination, can be prospectively validated and demonstrate clinical utility in assessing treatment response.

Manufacturing and Supply

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Viaskin is a Highly Scalable Manufacturing Technology

We currently rely on a single contract manufacturer to manufacture and supply the active pharmaceutical ingredients (“API”) used in our Viaskin product candidates.

On February 1, 2018, we entered into a Master API Supply Agreement with Sanofi which sets forth the terms and conditions governing the manufacture and supply of peanut, milk and egg API to be used in our Viaskin product candidates.

The agreement expires on a Viaskin product basis five years after the first date of regulatory approval in any jurisdiction of the applicable Viaskin product candidate and requires us to purchase at least 75% of our required API from Sanofi.

We believe our proprietary Viaskin manufacturing technology creates high barriers to entry to our line of business, particularly in the engineering and manufacturing of our Viaskin product candidates.

We have designed, developed, and built our manufacturing tools, and contract third-party manufacturers to operate it.

We currently rely on a single contract manufacturer, FAREVA Amboise (“FAREVA”), to manufacture and supply clinical and commercial batches of Viaskin Peanut patches.

We have entered into a Development Services Agreement, dated August 1, 2015, as amended (the “Development Agreement”), with FAREVA setting forth the terms and conditions whereby DBV selected FAREVA as its contract manufacturing organization to implement the Viaskin production process and to manufacture and supply to DBV batches of finished product for validation and clinical purposes.

Viaskin, a Highly Scalable Manufacturing Technology

Our proprietary Viaskin manufacturing technology is deemed to create high barriers to entry to our line of business, particularly in the engineering and manufacturing of our Viaskin product candidates.

We have designed, developed, and built our manufacturing tools, and contracted with third-party manufacturers to operate it.

Development & Potential Commercialization - Sanofi

On August 29, 2025, DBV Technologies S.A.

updated its Manufacturing and Supply Agreement (the “Supply Agreement”) with SANOFI WINTHROP INDUSTRIE (“SANOFI”), under which SANOFI will manufacture and supply the Viaskin Peanut API exclusively for DBV Technologies S.A.

during the agreement term.

The Supply Agreement has an effective date of January 1, 2025 and initial term of 4 years with a possibility to extend for an additional period.

This Agreement includes terms related to manufacturing, quality control, pricing, volume commitments, and supply obligations.

The Agreement is designed to secure commercial-scale manufacturing capacity in preparation for a potential BLA submission and subsequently, the commercial launch of the Viaskin Peanut patch in the United States.

The Company currently relies on a single contract manufacturer, FAREVA Amboise (“FAREVA”), to manufacture and supply clinical batches of Viaskin® patches.

The Company has entered into a Development Services Agreement, dated August 1, 2015, with FAREVA, which sets forth the terms and conditions under which the Company selected FAREVA as its Contract Manufacturing Organization (“CMO”) to implement the production process for Viaskin® patches and to manufacture and supply the Company with batches of finished products for clinical and validation purposes.

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.

The Company entered into a Services Agreement with FAREVA La Vallée, dated March 18, 2024 (the “PSM Services Agreement”), for the construction of a dedicated production line and the technology transfer from SANOFI for the manufacture of the Peanut Source Material (“PSM”) required for the production of Viaskin Peanut patches .

The PSM Services Agreement also included binding commercial terms related to the manufacture and supply of commercial batches, the main provisions of which were incorporated into that certain Manufacturing and Supply Agreement (“MS Agreement”) effective as of March 17, 2026 between the Company and Fareva La Vallee.

setting forth the terms and conditions for the manufacture and supply of PSM by Fareva La Vallee.

Intellectual Property

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These patents and applications generally fall into five broad categories:

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, 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;

• 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.

• 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.

Patent Term Extension and Marketing Exclusivity

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The amount of time by which a patent term may be extended is generally one-half the time between the effective date of an IND submission and the submission date of a BLA plus the time between the submission date of a BLA and the FDA’s approval of that application, except that the review period is reduced by any time during which the applicant failed to exercise due diligence.

Only one patent applicable to an approved drug is eligible for the extension and the application for the extension must be submitted prior to the expiration of the patent, and within 60 days of the FDA’s approval of the product.

Patent and Trademark Office, or USPTO, in consultation with the FDA, reviews and approves the application for any patent term extension.

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.

Some foreign jurisdictions have analogous patent term extension provisions that allow for extension of the term of a patent that covers a device approved by the applicable foreign regulatory agency.

Only one patent applicable to an approved product is eligible for the extension.

The approval must be the first approval of that product by the FDA, and the application for the extension must be submitted prior to the expiration of the patent, and within 60 days of the FDA’s approval of the product.

Patent and Trademark Office (“USPTO”) in consultation with the FDA, reviews and approves the application for any patent term extension.

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.

Some foreign jurisdictions have analogous patent term extension provisions that allow for extension of the term of a patent that covers a product approved by the applicable foreign regulatory agency.

In the future, if a Viaskin patch receives FDA approval, we expect to apply for a patent term extension on the patent that we believe will provide the best exclusivity position for that product if extended.

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.

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.

Interchangeability requires that a biological product be biosimilar to the reference product and the product can be expected to produce the same clinical results as the reference product in any given patient and, for products administered multiple times, the product and the reference product may be alternated or switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biological product.

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.

“First licensure” typically means the initial date the particular product at issue was licensed in the United States.

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.

changes its safety, purity, or potency.

Whether a subsequent application, if approved, warrants exclusivity as the “first licensure” of a biological product is determined on a case-by-case basis with data submitted by the sponsor.

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In December 2008, we entered into an assignment, development and co-ownership agreement with AP-HP and Université Paris-Descartes, which through a merger and a name change became Université Paris Cité, by which we agreed to terms of co-ownership with AP-HP and Université Paris Cité of certain U.S.

and foreign patents and patent applications, referred to herein as the shared patents.

We, and any licensees or sublicensees that we designate, have the exclusive right to commercial uses of the shared patents.

and foreign patents and patent applications, referred to herein as the “shared patents.” We, and any licensees or sublicensees that we designate, have the exclusive right to commercial uses of the shared patents.

AP-HP and Université Paris Cité agreed to use the shared patents only for internal research purposes and not to license the shared patents to any third party.

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.

This royalty is in the low single digits and varies depending on the particular patent.

Additionally, if we license any of the shared patents to a third party and a licensee commercializes products covered by such shared patents, we will be obligated to pay AP-HP and Université Paris Cité a percentage in the low single digits of the money that we receive from our licensee.

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.

Any party may terminate the assignment, development and co-ownership agreement in the event of another party’s substantial breach which remains uncured after six months of receiving written notice of such breach.

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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.

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.

In addition, our ownership stake in certain jointly made improvements covered by, or depending on, at least one of the shared patents would survive termination of the agreement.

The longest-lived patent rights under the agreement are currently expected to expire in 2031, absent patent term extension.

Contract Research Organizations (CROs)

The Company engages CROs in the conduct and oversight of clinical trials sponsored by the Company:

Agreement Related to the Phase 3 VITESSE - Clinical Trial with SYNEOS HEALTH France SARL

The Company entered into a work order on September 15, 2022 (the “SYNEOS Work Order”), pursuant to the terms of a Master Services Agreement dated July 15, 2014, as amended (the “SYNEOS MSA”), with SYNEOS HEALTH France SARL (“SYNEOS”) for the initiation of the VITESSE Phase 3 study.

The purpose of this SYNEOS Work Order is to implement all start-up, monitoring, and close-out activities necessary for the conduct of the VITESSE clinical trial through the delivery of the final clinical study report.

The SYNEOS Work Order will terminate upon completion of the services described in the SYNEOS Work Order, unless terminated earlier as defined in the SYNEOS MSA.

Agreement Related to the Phase 3 COMFORT Toddlers - Clinical Trial with ICON

The Company entered into a task order, effective as of January 15, 2025, as amended (the “ICON Task Order”), pursuant to the terms of a Master Agreement for Clinical Trials Management Services, dated December 5, 2011 (the “ICON MSA”), with ICON Clinical Research Limited (“ICON”) for the conduct of the COMFORT Toddlers supplemental safety study.

The purpose of the ICON Task Order is to implement all start-up, monitoring, and close-out activities necessary for the conduct of the COMFORT Toddlers clinical trial through the delivery of the final clinical study report.

The agreement will terminate upon completion of the services described in the ICON Task Order, unless terminated earlier as defined in the ICON MSA.

Agreement Related to the Phase 3 EPOPEX - Clinical Trial with PRA / ICON

DBV Technologies S.A.

entered into a service agreement on May 24, 2018 with ICON, as successor in interest to Pharmaceutical Research Associates, Inc.

for the management of the Phase 3 study EPOPEX.

The purpose of this agreement was to implement all start-up, monitoring, and close-out activities necessary for the conduct of this clinical trial through the delivery of the final clinical study report.

Agreement Related to planned Phase II Clinical Trial with Advanced Clinical

The Company has entered into a work order, effective November 18, 2025 (the “Advanced Clinical Work Order”), pursuant to a Master Services Agreement, effective March 18, 2025 (the “Advanced Clinical MSA”), with Advanced Clinical LLC (“Advanced Clinical”) for the conduct of the Phase II clinical study to assess the efficacy and safety of Viaskin Peanut patch in achieving ad lib consumption of dietary peanut in peanut allergic infants 6 through 12 months of age.

The purpose of the Advanced Clinical Work Order is to implement all start-up, monitoring, and close-out activities necessary for the conduct of this clinical trial through the delivery of the final clinical study report.

This Advanced Clincial Work Order expires upon completion of the services, unless terminated earlier as defined in the Advanced Clinical MSA.

Agreement Related to the Expanded Access Program

The Company entered into a statement of work, dated November 10, 2023, as amended (the “EAC SOW”), pursuant to a Master Services Agreement, dated February 21, 2020 (the “EAC MSA”), with Early Access Care LLC (“EAC”) for the conduct and management of an expanded access program.

The EAC SOW expires as of December 31, 2026, unless terminated earlier in accordance with the EAC MSA between the two parties December 31, 2026.

The biotechnology and pharmaceutical industries are highly competitive and subject to significant and rapid change as researchers learn more about diseases and develop new technologies and treatments.

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We are aware of several food allergy studies and pharmaceutical developmental efforts connected with such studies that are currently being conducted in major medical centers and hospitals worldwide.

These studies are evaluating forms of allergen desensitization treatments such as oral, or OIT;

sublingual, or SLIT;

subcutaneous, or SCIT;

oral mucosal, or OMIT;

cutaneous and intranasal, or INT immunotherapy, synthetic, denatured allergens, small molecule inhibitors, or combinations of medicines or methods.

These studies are evaluating forms of allergen desensitization treatments such as OIT;

subcutaneous (“SCIT”);

oral mucosal (“OMIT”);

cutaneous and intranasal (“INT”) immunotherapy, synthetic, denatured allergens, small molecule inhibitors, or combinations of medicines or methods.

Studies combining methods of allergen immunotherapy, such as OIT, with monoclonal antibodies also are being conducted currently.

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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.

Palforzia, a formulation of peanut flour developed by Aimmune Therapeutics, Inc.

acquired Aimmune in October 2020 and divested the Palforzia business to Stallergenes Greer in September 2023.

In December 2025, Stallergenes Greer announced that it intends to discontinue the commercialization of Palforzia, on July 31, 2026.

In addition, Xolair (omalizumab) is approved by the FDA for the reduction of allergic reactions including reducing the risk of anaphylaxis, that may occur with accidental exposure to one or more food allergens, including peanut.

Omalizumab is an anti-immunoglobulin E (IgE) monoclonal antibody that is administered via subcutaneous injection.

Omalizumab is an anti-IgE monoclonal antibody that is administered via subcutaneous injection.

The prescribing information for both Palforzia and Xolair indicate patients should continue to avoid all foods to which they are allergic.

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Biological Product Development

In the United States, the FDA regulates biologics under the Federal Food, Drug, and Cosmetic Act, or FDCA, and the Public Health Service Act, or PHSA, and their implementing regulations.

In the United States, the FDA regulates biologics under the Federal Food, Drug, and Cosmetic Act (“FDCA”) and the Public Health Service Act (“PHSA”) and their implementing regulations.

Biologics are also subject to other federal, state and local statutes and regulations.

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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;

• 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, or cGMP, requirements to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality, purity and potency;

• 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;

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The central focus of an IND submission is on the general investigational plan and the protocol(s) for human trials.

The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA raises concerns or questions regarding the proposed clinical trials and places the IND on

clinical hold within that 30-day time period.

The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA raises concerns or questions regarding the proposed clinical trials and places the IND on clinical hold within that 30-day time period.

In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin.

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Each protocol, and any subsequent amendments to such protocol, must be submitted to the FDA as part of the IND.

Further, each clinical trial must be reviewed and approved by an independent institutional review board, or IRB, at or servicing each institution at which the clinical trial will be conducted.

Further, each clinical trial must be reviewed and approved by an independent IRB at or servicing each institution at which the clinical trial will be conducted.

An IRB is charged with protecting the welfare and rights of trial participants and considers such items as whether the risks to participants in a clinical trial are minimized and are reasonable in relation to anticipated benefits.

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Progress reports detailing the results of a clinical trial must be submitted periodically to the FDA.

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.

adverse reaction over that listed in the protocol or investigator brochure.

Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, if at all.

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This group provides authorization for whether or not a trial may move forward at designated intervals based on access to certain data from the trial.

A sponsor may also suspend or terminate a clinical trial based on evolving business objectives and/ or competitive climate.

Concurrent with clinical trials, companies usually complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the product candidate as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements.

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FDA approval of a BLA must be obtained before a biologic product may be marketed in the United States.

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.

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.

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For example, the FDA may require Phase 4 testing which involves clinical trials designed to further assess the product’s safety and effectiveness and may require testing and surveillance programs to monitor the safety of approved products that have been commercialized.

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.

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.

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Any product submitted to the FDA for marketing, including under a fast track program, may be eligible for other types of FDA programs intended to expedite development and review, such as priority review and accelerated approval.

Any product is eligible for priority review, or review within a six-month timeframe from the date a complete BLA is accepted for filing, if it treats a serious condition and has the potential to provide a significant

improvement in safety or effectiveness.

The FDA will attempt to direct additional resources to the evaluation of an application for a new drug or biological product designated for priority review in an effort to facilitate the review.

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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.

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.

A product can be designated as a breakthrough therapy if it is intended to treat a serious or life-threatening condition and preliminary clinical evidence indicates that it may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

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Pediatric Trials

Under the Pediatric Research Equity Act, or PREA, a BLA or supplement to a BLA must contain data to assess the safety and efficacy of the product for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective.

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.

Under the Pediatric Research Equity Act (“PREA”) a BLA or supplement to a BLA must contain data to assess the safety and efficacy of the product for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the

product is safe and effective.

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.

The initial PSP must include an outline of the pediatric study or studies that the sponsor plans to conduct, including study objectives and design, age groups, relevant endpoints and statistical approach, or a justification for not including such detailed information, and any request for a deferral of pediatric assessments or a full or partial waiver of the requirement to provide data from pediatric studies along with supporting information.

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The FDA regulations require that products be manufactured in specific approved facilities and in accordance with cGMP.

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.

We rely, and expect to continue to rely, on third parties for the production of clinical and commercial quantities of our products in accordance with cGMP regulations.

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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.

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 the United States, sales, marketing and scientific/educational programs, among other activities, must also comply with state and federal fraud and abuse laws, data privacy and security laws, transparency laws, and pricing and reimbursement requirements in connection with governmental payor programs, among others.

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European Union Drug Development

In the European Union, or the EU, product candidates are also subject to extensive regulatory requirements.

In the European Union (“EU”) product candidates are also subject to extensive regulatory requirements.

Approval from the competent authorities of EU Member States must be obtained before commencing clinical trials.

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These GLP standards reflect the Organization for Economic Co-operation and Development requirements.

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.

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.

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.

Prior to commencing a clinical trial, the sponsor must obtain a clinical trial authorization from competent authorities of EU Member States in which the sponsor intends on carrying out clinical trials, and a positive opinion from an independent Ethics Committee.

The CTR, which is directly applicable in all EU Member States, introduces a streamlined application procedure through a single-entry point, the “EU portal”, the Clinical Trials Information System, or CTIS.

Since January 31, 2023, the use of CTIS has become mandatory for all clinical trial sponsors submitting initial applications for the approval of their clinical trials in the EU.

The CTR also establishes a single set of documents to be prepared and submitted for the application including, among other things, a copy of the trial protocol and an Investigational Medicinal Product Dossier (“IMPD”) containing information about the manufacture and quality of the medicinal product under investigation, as well as simplified reporting procedures for clinical trial sponsors.

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Individual EU Member States, therefore, retain the power to authorize the conduct of clinical trials in their territory.

The CTR establishes a general principle according to which information contained in CTIS shall be made publicly accessible unless confidentiality is justified on grounds of necessary to protect personal data, or commercially confidential information, necessary to protect confidential communications between EU Member States in relation to the preparation of an assessment report, or necessary to ensure effective supervision of the conduct of a clinical

trial by EU Member States.

The confidentiality exception may be overruled if there is an overriding public interest in disclosure.

The publication of data and documents in relation to the conduct of a clinical trial will take place in accordance with specific timelines.

The timelines are established by the European Medicines Agency, or EMA, and are determined based on the documents and the categorization of the clinical trial.

The CTR foresaw a three-year transition period that ended on January 31, 2025.

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In all cases, clinical trials must be conducted in accordance with GCP and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.

Medicines used in clinical trials, including advanced therapy medicinal products, or ATMPs, must be manufactured in accordance with the guidelines on cGMP and in a GMP licensed facility, which can be subject to GMP inspections.

Medicines used in clinical trials must be manufactured in accordance with the guidelines on cGMP and in a GMP licensed facility, which can be subject to GMP inspections.

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.

To obtain a MA for a product in the EU, an applicant must submit a Marketing Authorization Application, or MAA either under a centralized procedure administered by the EMA or one of the procedures administered by competent authorities of EU Member States (decentralized procedure, national procedure or mutual recognition procedure).

To obtain a MA for a product in the EU, an applicant must submit a MAA either under a centralized procedure administered by the EMA or one of the procedures administered by competent authorities of EU Member States (decentralized procedure, national procedure or mutual recognition procedure).

An MA may be granted only to an applicant established in the EU.

The centralized procedure provides for the grant of a single MA by the European Commission that is valid throughout the EEA.Pursuant to Regulation (EC) No.

726/2004, the centralized procedure is compulsory for specific products, including for (i) medicinal products derived from biotechnological processes, (ii) products designated as orphan medicinal products, (iii) ATMPs, and (iv) products with a new active substance indicated for the treatment of HIV/AIDS, cancer, neurodegenerative diseases, diabetes, auto immune and other immune dysfunctions and viral diseases.

The centralized procedure provides for the grant of a single MA by the European Commission that is valid throughout the EEA.

Pursuant to Regulation (EC) No.

726/2004, the centralized procedure is compulsory for specific products, including for (i) medicinal products derived from biotechnological processes, (ii) products designated as orphan medicinal products, (iii) ATMPs, and (iv) products with a new active substance indicated for the treatment of HIV/AIDS, cancer, neurodegenerative diseases, diabetes, autoimmune and other immune dysfunctions and viral diseases.

For products with a new active substance indicated for the treatment of other diseases and products that are highly innovative or for which a centralized process is in the interest of patients, authorization through the centralized procedure is optional on related approval.

Under the centralized procedure, the EMA’s Committee for Medicinal Products for Human Use, or CHMP, conducts the initial assessment of a product.

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.

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The resulting assessment report is submitted to the concerned EU Member States who, within 90 days of receipt, must decide whether to approve the assessment report and related materials.

If a concerned EU Member State cannot approve the assessment report and related materials due to concerns relating to a potential serious risk to public health, disputed elements may be referred to the Heads of Medicines Agencies’ Coordination Group for Mutual Recognition and Decentralised Procedures – Human, or CMDh, for review.

If a concerned EU Member State cannot approve the assessment report and related materials due to concerns relating to a potential serious risk to public health, disputed elements may be referred

to the Heads of Medicines Agencies’ Coordination Group for Mutual Recognition and Decentralised Procedures – Human (“CMDh”) for review.

The subsequent decision of the European Commission is binding on all EU Member States.

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Any authorization which is not followed by the actual placing of the medicinal product on the EU market (for a centralized MA) or on the market of the authorizing EU Member State within three years after authorization ceases to be valid (the so-called sunset clause).

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.

PRIME is a voluntary scheme aimed at enhancing the EMA’s support for the development of medicinal products that target unmet medical needs.

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Benefits accrue to sponsors of product candidates with PRIME designation, including but not limited to, early and proactive regulatory dialogue with the EMA, frequent discussions on clinical trial designs and other development program elements, and potentially accelerated MAA assessment once a dossier has been submitted.

Importantly, a dedicated contact and rapporteur from the EMA’s Committee for Human Medicinal Products, or CHMP, or Committee for Advanced Therapies, are appointed early in the PRIME scheme facilitating increased understanding of the product at EMA’s Committee level.

A kick-off meeting initiates these relationships and includes a team of multidisciplinary experts at the EMA to provide guidance on the overall development and regulatory strategies.

Where, during the course of development, a medicine no longer meets the eligibility criteria, support under the PRIME scheme may be withdrawn.

In the EU, a “conditional” MA may be granted in cases where all the required safety and efficacy data are not yet available.

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In the EU, Regulation (EC) No.

1901/2006 provides that all MAAs for new medicinal products have to include the results of trials conducted in the pediatric population, in compliance with a pediatric investigation plan, or PIP, agreed with the EMA’s Pediatric Committee, or PDCO.

1901/2006 provides that all MAAs for new medicinal products have to include the results of trials conducted in the pediatric population, in compliance with a pediatric investigation plan (“PIP”) agreed with the EMA’s Pediatric Committee (“PDCO”).

The PIP sets out the timing and measures proposed to generate data to support a pediatric indication of the medicinal product for which the MA is being sought.

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Further, the obligation to provide pediatric clinical trial data can be waived by the PDCO when these data are not needed or appropriate because the product is likely to be ineffective or unsafe in children, the disease or condition for which the product is intended occurs only in adult populations, or when the product does not represent a significant therapeutic benefit over existing treatments for pediatric patients.

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.

Data and Market Exclusivity

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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.

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.

Key obligations include expedited reporting of suspected serious adverse reactions and submission of periodic safety update reports (“PSURs”).

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.

Such risk-minimization measures or post-authorization obligations may include additional safety monitoring, more frequent submission of PSURs, or the conduct of additional clinical trials or post-authorization safety studies.

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.

Although general requirements for advertising and promotion of medicinal products are established under EU legislation, the details are governed by regulations in individual EU Member States and can differ from one country to another.

For example, applicable laws require that promotional materials and advertising in relation to medicinal products comply with the product’s Summary of Product Characteristics, or SmPC, which may require approval by the competent national authorities in connection with an MA.

For example, applicable laws require that promotional materials and advertising in relation to medicinal products comply with the product’s Summary of Product Characteristics (“SmPC”) which may require approval by the competent national authorities in connection with an MA.

The SmPC is the document that provides information to physicians and other healthcare professionals concerning the safe and effective use of the product.

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Direct-to-consumer advertising of prescription medicinal products is also prohibited in the EU.

Much like the Anti-Kickback Statute prohibition in the United States, described above, the provision of benefits or advantages to physicians and other health care professionals to induce or encourage the prescription, recommendation, endorsement, purchase, supply, order or use of medicinal products is also prohibited in the EU.

Interactions between pharmaceutical companies and health care professionals are governed by strict laws, such as national anti-bribery laws of European countries, national sunshine rules, regulations, industry self-regulation codes of conduct and physicians’ codes of professional conduct.

Failure to comply with these requirements could result in reputational risk, public reprimands, administrative penalties, fines or imprisonment.

Payments made to physicians and other health care professionals in certain EU Member States must be publicly disclosed.

Moreover, agreements with health care professionals may require prior notification or approval by the health care professional’s employer, his or her competent professional organization and/or the regulatory authorities of the individual EU Member States.

Failure to comply with these requirements could result in reputational risk, public reprimands, administrative penalties, fines or imprisonment.

Combination Products

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Drug-device combination products that form a single integral product that is not reusable and for which the action of the medicinal product is principal to that of the medical device are governed by the regulatory framework applicable to medicinal products.

However, the General Safety and Performance Requirements, or GSPRs, of Annex I to Regulation (EU) 2017/745 on Medical Devices, or MDR, will be applicable to the safety and performance of the medical device part of the product in the context of its use with the medicinal product.

However, the General Safety and Performance Requirements (“GSPRs”) of Annex I to Regulation (EU) 2017/745 on Medical Devices (“MDR”) will be applicable to the safety and performance of the medical device part of the product in the context of its use with the medicinal product.

In these circumstances, an MAA must be submitted to the competent authorities responsible for evaluating the safety and effectiveness of medicinal products.

EU Declaration of Conformity of the device or the relevant Certificate of Conformity issued by a Notified Body.

As part of the MAA, the applicant must also submit, where available, the results of the assessment of the conformity of the medical device part of the product with the MDR contained in the manufacturer’s EU Declaration of Conformity of the device or the relevant Certificate of Conformity issued by a Notified Body.

If the MAA does not include the results of the conformity assessment, and where the conformity assessment of the device, if used separately, requires the involvement of a Notified Body, the competent authorities must require the applicant to provide a Notified Body Opinion on the conformity of the device with the relevant GSPRs.

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Where the primary mode of action of the combined product comes from the medicinal product, it is regulated as a medicinal product.

In this case, the medicinal product should also be compliant with regulation (EU) 2017/745 and particularly the Article 117.

Unless an express waiver is granted by the applicable Notified Body, Article 117 requires a Notified Body opinion on the conformity of the device part to the relevant General Safety and Performance Requirements, or GSPRs of the MDR.

.In this case, the medicinal product should also be compliant, in whole or in part, with regulation (EU) 2017/745 and particularly the Article 117.

Unless an express waiver is granted, Article 117 requires a Notified Body opinion on the conformity of the device part to the relevant GSPRs of the MDR.

An exemption may be granted from the authorities if the request is justified.

Other Regulatory Matters

UK Regulations

The United Kingdom’s, or UK, withdrawal from the EU on January 31, 2020, commonly referred to as Brexit, has changed the regulatory relationship between the UK and the EU.

The Medicines and Healthcare products Regulatory Agency, or MHRA, is now the UK’s standalone regulator for medicinal products and medical devices.

The Medicines and Healthcare products Regulatory Agency (“MHRA”) is now the United Kingdom’s (“UK”) standalone regulator for medicinal products and medical devices.

The United Kingdom is now a third country to the EU.

The UK regulatory framework in relation to clinical trials is governed by the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended, which is derived from the CTD, as implemented into UK national law through secondary legislation.

On January 17, 2022, the MHRA launched an eight-week consultation on reframing the UK legislation for clinical trials, and which aimed to streamline clinical trials approvals, enable innovation, enhance clinical trials transparency, enable greater risk proportionality, and promote patient and public involvement in clinical trials.

The UK Government published its response to the consultation on March 21, 2023 confirming that it would bring forward changes to the legislation and such changes were laid in parliament on December 12, 2024.

These resulting legislative amendments will, if implemented in their current form, bring the United Kingdom into closer alignment with the CTR.

In October 2023, the MHRA announced a new Notification Scheme for clinical trials which enables a more streamlined and risk-proportionate approach to initial clinical trial applications for Phase 4 and low-risk Phase 3 clinical trial applications.

While the United Kingdom’s regulatory framework for clinical trials was historically based on the Medicines for Human Use (Clinical Trials) Regulations 2004, which implemented the former EU Clinical Trials Directive, this has been significantly reformed by the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024.

The new legislation, which was adopted in April 2025, modernizes the United Kingdom's approach to make it a more attractive location for research, and includes key features such as:

(i) a risk-proportionate approach, including a notification scheme for lower-risk trials;

(ii) a combined review process integrating ethics committee and regulatory approvals into a single, streamlined pathway;

(iii) enhanced transparency requirements mandating registration of clinical trials in a public registry and publication of trial results within 12 months of trial completion (with scope for deferrals in certain circumstances);

(iv) greater flexibility to support innovation in clinical trial design;

and (v) measures to promote patient and public involvement.

The amendments will become applicable on April 28, 2026 following a one-year transition period.

Marketing authorizations in the United Kingdom are governed by the Human Medicines Regulations (SI 2012/1916), as amended.

Since January 1, 2021, an applicant for the EU’s centralized procedure marketing authorization can no longer be established in the United Kingdom.

As a result, since this date, companies established in the United Kingdom cannot use the EU’s centralized procedure.

In order to obtain a United Kingdom MA to commercialize products in the United Kingdom, an applicant must be established in the United Kingdom and must follow one of the United Kingdom national authorization procedures or one of the remaining post-Brexit international cooperation procedures.

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All existing marketing authorizations of the EU for centrally authorized products were automatically converted or grandfathered into the United Kingdom’s marketing authorization, effective in Great Britain only, free of charge on January 1, 2021, unless the marketing authorization holder opted-out of this possibility.

Northern Ireland remained within the scope of authorizations of the EU in relation to centrally authorized medicinal products until January 1, 2025.

However, on January 1, 2025, a new arrangement as part of the so-called “Windsor Framework” came into effect and reintegrated Northern Ireland under the regulatory authority of the MHRA with respect to medicinal products.

The Windsor Framework removes EU licensing processes and EU labeling and serialization requirements in relation to Northern Ireland and introduces a UK-wide licensing process for medicines.

On January 1, 2025, the “Windsor Framework” came into effect and reintegrating Northern Ireland under the regulatory authority of the MHRA with respect to medicinal products and introducing a UK-wide licensing process for medicines.

There is no pre-marketing authorization orphan designation for medicinal products in the UK.

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These third-party payors are increasingly reducing reimbursements for medical products and services.

The process for determining whether a third-party payor will provide coverage for a drug

product typically is separate from the process for setting the price of a drug product or for establishing the reimbursement rate that a payor will pay for the drug product once coverage is approved.

The process for determining whether a third-party payor will provide coverage for a drug product typically is separate from the process for setting the price of a drug product or for establishing the reimbursement rate that a payor will pay for the drug product once coverage is approved.

Third-party payors may limit coverage to specific drug products on an approved list, also known as a formulary, which might not include all of the FDA approved drugs for a particular indication.

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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.

Department of Health and Human Services (“HHS”), imposes rebates on many Medicare Part B and Medicare Part D products to penalize price increases that outpace inflation on an annual basis.

HHS has also been empowered to negotiate the price of certain single-source biologics that have been on the market for at least eleven (11) years covered under Medicare as part of the Medicare Drug Price Negotiation Program.

Each year up to twenty (20) products will be selected by HHS for the Medicare Drug Price Negotiation Program.

Products subject to the Medicare Drug Price Negotiation Program are expected to experience a significant reduction in reimbursement from the Medicare program on a per unit basis.

Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit our net revenue and results.

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

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.

For example, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or, collectively, the ACA, was enacted in March 2010 and continues to significantly impact the health care industry.

The ACA was expansive health reform legislation designed to expand coverage for the uninsured while at the same time containing overall healthcare costs enhance remedies against fraud and abuse, add new transparency requirements for health care and health insurance industries, impose new taxes and fees on the health industry and impose additional health policy reforms, and other changes.

With regard to biopharmaceutical products, among other things, the ACA expanded and increased industry rebates for drugs covered under Medicaid programs and made changes to the coverage requirements under the Medicare Part D program.

However, there have been executive, judicial and Congressional challenges and amendments to certain aspects of the ACA.

For example, on August 16, 2022, the Inflation Reduction Act of 2022, or IRA, was signed into law, which, among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025.

The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and creating a new manufacturer discount program.

It is possible that the ACA will be subject to judicial or Congressional challenges in the future.

It is unclear how such challenges and the healthcare reform measures of the second Trump administration will impact the ACA.

There have been executive, judicial and Congressional challenges and amendments to certain aspects of the ACA.

For example, on July 4, 2025, the One Big Beautiful Bill Ac (the “OBBBA”) was signed into law, which narrowed access to ACA marketplace exchange enrollment and declined to extend the ACA enhanced advanced premium tax credits that expired at the end of 2025, which, among other provisions in the law, are anticipated to reduce the number of Americans with health insurance.

The OBBBA also is expected to reduce Medicaid spending and enrollment by implementing work requirements for some beneficiaries, capping state-directed payments, reducing federal funding, and limiting provider taxes used to fund the program.

Congress is considering proposed legislation intended to further reduce healthcare costs with alternatives to replace the expired ACA subsidies.

In addition, other legislative changes have been proposed and adopted in the United States since the ACA was enacted.

On August 2, 2011, the Budget Control Act of 2011 among other things, created measures for spending reductions by Congress.

The Joint Select Committee on Deficit Reduction was tasked with recommending to Congress proposals in spending reductions.

Because they did not achieve a targeted deficit reduction of at least $1.2 trillion for fiscal years 2012 through 2021, it triggered the legislation’s automatic reduction to several government programs.

This includes aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, which went into effect in April 2013 and, due to subsequent legislative amendments, including the Infrastructure Investment and Jobs Act, will stay in effect until 2032, unless additional Congressional action is taken.

We expect that additional federal healthcare reform measures will be adopted in the future, particularly given the recent change in administration, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, and in turn could significantly reduce the projected value of certain development projects and reduce our profitability.

Additionally, in the United States, there have been several recent Congressional inquiries and federal and state legislative activity designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs.

At the federal level, the IRA, among other things, (i) directs the U.S.

Department of Health and Human Services, or HHS, to negotiate the price of certain high-expenditure, single-source biologics that have been on the market for at least 11 years covered under Medicare, and subject drug manufacturers to civil monetary penalties and a potential excise tax by offering a price that is not equal to or less than the negotiated “maximum fair price” for such drugs and biologics under the law, or the “Medicare Drug Price Negotiation Program”, and (ii) imposes rebates with respect to certain drugs and biologics covered under Medicare Part B or Medicare Part D to penalize price increases that outpace inflation.

These provisions began to take effect progressively starting in fiscal year 2023.

On August 15, 2024, HHS announced the agreed-upon prices of the first ten drugs that were subject to price negotiations, although the Medicare Drug Price Negotiation Program is currently subject to legal challenges.

On January 17, 2025, HHS selected 15 additional products covered under Part D for price negotiation in 2025.

Each year thereafter more Part B and Part D products will become subject to the Medicare Drug Price Negotiation Program.

On December 8, 2023, the National Institute of Standards and Technology published for comment a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights which for the first time includes the price of a product as one factor an agency can use when deciding to exercise march-in rights.

While march-in rights have not previously been exercised, it is uncertain if that will continue under the new framework.

At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

Additional health reform measures may continue and affect our business in unknown ways, particularly given the recent change in administration.

The current Trump administration is pursuing policies to reduce regulations and expenditures across government including at HHS, the FDA, CMS and related agencies.

These changes include aggregate reductions to Medicare payments to providers of 2% per fiscal year, which began in 2013 and will remain in effect until 2032 unless additional Congressional action is taken.

The current administration is pursuing policies to reduce regulations and expenditures across government agencies including at HHS, the FDA, CMS and related agencies.

These actions, presently directed by executive orders or memoranda from the Office of Management and Budget, may propose policy changes that create additional uncertainty for our business.

These actions may include, for example, directives to reduce agency workforce, rescinding a Biden administration executive order tasking the Center for Medicare and Medicaid Innovation, or CMMI, to consider new payment and healthcare models to limit drug spending and eliminating the Biden administration’s executive order that directed HHS to establishing an AI task force and developing a strategic plan, and directing certain federal agencies to enforce existing law regarding hospital and price plan transparency and by standardizing prices across hospitals and health plans.

Additionally, in its June 2024 decision in Loper Bright Enterprises v.

Raimondo, or Loper Bright, the U.S.

Supreme Court overturned the longstanding Chevron doctrine, under which courts were required to give deference to regulatory agencies’ reasonable interpretations of ambiguous federal statutes.

The Loper Bright decision could result in additional legal challenges to current regulations and guidance issued by federal agencies applicable to our operations, including those issued by the FDA.

Congress may introduce and ultimately pass health care related legislation that could impact the drug approval process and make changes to the Medicare Drug Price Negotiation Program created under the IRA.

Cost containment measures that healthcare payors and providers are instituting and the effect of further healthcare reform could significantly reduce potential revenues from the sale of any of our product candidates approved in the future, and could cause an increase in our compliance, manufacturing, or other operating expenses.

For example, the current administration has announced agreements with several pharmaceutical companies that require the drug manufacturers to offer, through a direct to consumer platform, or TrumpRx, U.S.

patients and Medicaid programs prescription drug Most-Favored Nation pricing equal to or lower than those paid in other developed nations, with additional mandates for direct-to-patient discounts and repatriation of foreign revenues.

Other recent actions, for example, include (1) directing agencies to reduce agency workforce and cut programs;

(2) directing HHS and other agencies to lower prescription drug costs through a variety of initiatives;

(3) imposing tariffs on imported pharmaceutical products;

and (4) as part of the Make America Healthy Again (“MAHA”) Commission’s Strategy Report released in September 2025, working across government agencies to increase enforcement on direct-to-consumer pharmaceutical advertising.

Additionally, the current administration recently called on Congress to enact "The Great Healthcare Plan," to codify and expand Most-Favored Nation pricing, lower government subsidies to private insurance companies, increase healthcare price transparency, expand pharmaceutical drugs available for over-the-counter purchase, and enact restrictions on pharmacy benefit manager, or PBM, payment methodologies, among other things.

These actions and policies may significantly reduce U.S.

drug prices, potentially impacting manufacturers’ global pricing strategies and profitability, while increasing their operational costs and compliance risks.

In June 2024, the U.S.

Supreme Court’s Loper Bright decision greatly reduced judicial deference to regulatory agencies, which could increase successful legal challenges to federal regulations affecting our operations.

Congress may introduce and ultimately pass health care related legislation that could impact the drug approval process and make changes to the Medicare Drug Price Negotiation Program.

In addition, in some foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed.

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162-17 of the Social Security Code).

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).

A framework agreement has been concluded between LEEM (the trade union representing the pharmaceutical industries) and CEPS.

In addition, EU Member States often require the completion of additional health technology assessments that compare the cost- effectiveness of a particular product candidate to currently available therapies.

This Health Technology Assessment (HTA) process is the procedure according to which the assessment of the public health impact, therapeutic impact and the economic and societal impact of use of a given medicinal product in the national healthcare systems of the individual country is conducted.

The outcome of HTA regarding specific medicinal products will often influence the pricing and reimbursement status granted to these medicinal products by the competent authorities of individual EU Member States.

At the EU level, on January 12, 2025, Regulation No 2021/2282 on Health Technology Assessment (HTA Regulation), entered into application through a phased implementation.

The Regulation initially applies to new active substances for oncology and ATMPs.

It will be expanded to orphan medicinal products in January 2028, and to all centrally authorized medicinal products as of 2030.

Select high-risk medical devices also came into scope in 2026.

The HTA Regulation is intended to boost cooperation among Member States in assessing health technologies, including new medicinal products.

The Regulation establishes a framework for EU‑level joint clinical assessments, joint scientific consultations, and the early identification of emerging health technologies.

The Regulation permits EU Member States to use common tools, methodologies, and procedures and requires them to rely on EU‑level joint clinical assessment reports for the clinical components of their national HTA evaluations.

Individual EU Member States will continue to be responsible for assessing non-clinical (e.g., economic, social, ethical) aspects of health technologies, and making decisions on pricing and reimbursement.

In light of the fact that the United Kingdom has left the EU, Regulation No 2021/2282 on HTA will not apply in the United Kingdom.

However, the UK Medicines and Healthcare products Regulation Agency (MHRA) is working with UK HTA bodies and other national organizations, such as the Scottish Medicines Consortium (SMC), the National Institute for Health and Care Excellence (NICE), and the All-Wales Medicines Strategy Group, to introduce new pathways supporting innovative approaches to the safe, timely and efficient development of medicinal products, including, effective as of 31 March 2025, relaunching the Innovative Licensing and Access Pathway with more predicable timelines and closer involvement of the National Health Service.

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).

A framework agreement has been concluded between Les Enterprises du Médicament (“LEEM”), the trade union representing the pharmaceutical industries, and CEPS.

The last framework agreement was signed on March 5, 2021 and has a three-year term.

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• 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.

• 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.

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;

• 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;

• 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;

• 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 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;

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.

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It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws.

If our operations are found to be in violation of any of these laws or any other governmental

regulations that may apply to us, we may be subject to significant administrative, civil, and/or criminal penalties, damages, fines, disgorgement, individual imprisonment, exclusion from government funded healthcare programs, such as Medicare and Medicaid, or comparable foreign programs, integrity obligations, contractual damages, reputational harm, diminished profits and future earnings, and the curtailment or restructuring of our operations.

If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant administrative, civil, and/or criminal penalties, damages, fines, disgorgement, individual imprisonment, exclusion from government funded healthcare programs, such as Medicare and Medicaid, or comparable foreign programs, integrity obligations, contractual damages, reputational harm, diminished profits and future earnings, and the curtailment or restructuring of our operations.

If the physicians or other healthcare providers or entities with whom we expect to do business are found to be not in compliance with applicable laws, they may be subject to significant administrative, civil, and/or criminal sanctions, including individual imprisonment and exclusion from government funded healthcare programs.

Data Privacy and Security

We are subject to stringent and evolving United States and foreign laws, regulations, rules, contractual obligations, policies and other obligations related to data privacy and security, including the EU’s General Data Protection Regulation ((EU) 2016/679), or GDPR, and the UK’s General Data Protection Regulation, or UK GDPR.

We are subject to stringent and evolving United States and foreign laws, regulations, rules, contractual obligations, policies and other obligations related to data privacy and security, including the EU’s General Data Protection Regulation ((EU) 2016/679) (“EU GDPR”) and the UK’s General Data Protection Regulation (“UK GDPR”) (collectively, “GDPR”).

New privacy rules are being enacted in the United States and globally, and existing ones are being expanded, updated and strengthened.

Numerous U.S.

states have enacted comprehensive privacy laws that impose certain obligations on covered businesses, including providing specific disclosures in privacy notices and affording residents with certain rights concerning their personal data.

As applicable, such rights may include the right to access, correct, or delete certain personal data, and to opt-out of certain data processing activities, such as targeted advertising, profiling, and automated decision-making.

The exercise of these rights may impact our business and ability to provide our products and services.

Certain states also impose stricter requirements for processing certain personal data, including sensitive information, such as conducting data privacy impact assessments.

These state laws allow for statutory fines for noncompliance.

For example, the CCPA applies to personal data of consumers, business representatives, and employees who are California residents, and requires businesses to provide specific disclosures in privacy notices and honor requests of such individuals to exercise certain privacy rights.

The CCPA provides for fines and allows private litigants affected by certain data breaches to recover significant statutory damages.

The collection and use of personal health data in the EEA is governed by the GDPR, which became effective on May 25, 2018.

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The GDPR also imposes strict rules on the transfer of personal data outside of the EEA to countries that do not ensure an adequate level of protection, such as the U.S.

Failure to comply with the requirements of the GDPR and the related national data protection laws of the EEA Member States may result in fines up to €20 million or 4% of a company’s global annual revenues for the preceding financial year, whichever is higher.

Failure to comply with the requirements of the GDPR and the related national data protection laws of the EEA Member States may result in fines up to €20 million under the EU GDPR, 17.5 million pounds sterling under the UK GDPR or, in each case, or 4% of a company’s global annual revenues for the preceding financial year, whichever is higher.

Moreover, the GDPR grants data subjects the right to claim compensation for damages resulting from infringement of the GDPR.

Following the UK’s withdrawal and the expiration of the transition period, from January 31, 2020, companies doing business in the EU and the UK will be obliged to comply with both the GDPR and the UK GDPR.

On June 28, 2021, the European Commission adopted an adequacy decision permitting flows of personal data between the EU and the UK to continue without additional requirements.

However, the UK adequacy decision will automatically expire in June 2025 unless the European Commission re-assesses and renews or extends that decision and remains under review by the European Commission during this period.

The relationship between the UK and the EU in relation to certain aspects of data protection law remains unclear, and it is unclear how UK data protection laws and regulations will develop in the medium to longer term, and how data transfers to and from the UK will be regulated in the long term.

Employees and Human Capital Resources

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Our website address is http://www.dbv-technologies.com.

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”).

The SEC maintains a website that contains reports, proxy and information statements and other information regarding our filings at www.sec.gov .

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business