Business Description

of the offending allergen into their bloodstream can cause severe or life-threatening allergic reactions, such as anaphylactic shock. We believe Viaskin technology may offer convenient, non-invasive immunotherapy to patients. 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 Strategy 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 Patch for toddlers and children with peanut allergy; • seek regulatory approval for Viaskin ® Peanut Patch in the United States and the European Union; • advance the clinical development of additional Viaskin ® product candidates in the United States and other major markets; • build a broad immunotherapy product pipeline with our innovative Viaskin ® technology platform. The U.S. 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 Unmet Medical Need Peanut allergy is one of the most common food allergies globally with an overall prevalence across all age groups of approximately 1%, which increases up to 2% in the pediatric population. Based on a 2018 publication, an estimated 2.2% of the pediatric population in the United States, approximately 1.6 million children, is allergic to peanuts. This reflects an increasing prevalence, as has been shown by several epidemiologic studies, including a cross-sectional survey-based study in the United States in which the prevalence of peanut allergy more than tripled between 1997 and 2008 from 0.4% to 1.4%. Studies indicate that most children do not outgrow their peanut allergy, with resolution occurring in only about 20% of young children, making this allergy a life-long affliction in most cases. Clinically, an allergic reaction to peanut is characterized by rapid onset of symptoms which are triggered by the release of mediators from mast cells and basophils and typically involves one or more target organs. Presentation and severity of allergic reactions are unpredictable and may vary from mild to severe (anaphylaxis) within populations and within individuals over time. In the case of peanut allergy, all individuals are considered at risk for severe allergic reactions, irrespective of their past history.…