Slide 1: Corporate Presentation June 2025
DBV TECHNOLOGIES © 2024, DBV Technologies. All rights reserved Corporate Presentation I June 2025 Euronext Paris: DBV |ICorporate DBV Technologies Nasdaq: DBVT Overview
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation contains forward looking statements including, but not limited to, statements concerning DBV’s financial condition and forecast of its cash runway; the likelihood that warrants may be exercised following the disclosure of VITESSE topline results, should the re
Slide 3: Summary Overview of DBV Technologies
Summary Overview of DBV Technologies DBV Technologies | Corporate Overview 3
Slide 4: Our Mission is to Develop Novel Treatments for Pediatric Food Allergy
Our Mission is to Develop Novel Treatments for Pediatric Food Allergy Committed to transforming the lives of children & families living with the daily burden of food allergy Pioneered VIASKIN® patch technology Purposely designed to DBV’s novel approach to meet treatment goals of epicutaneous patient
Slide 5: Investment Highlights (US)
Investment Highlights (US) Two Distinct Opportunities Clear Clinical Pathway Anticipated Clinical & Transformational for TwoVIASKIN® Peanut Patch Distinct Opportunities for Both Programs Regulatory Milestones March ’25 Financing One BLA in 4-7 YO Ongoing, fully-enrolled 12- - Topline results for VIT
Slide 6: Transformational Financing (Announced March 27, 2025)
Transformational Financing (Announced March 27, 2025) Provides Runway Through Potential Approval & Launch of VIASKIN® Peanut Patch March 2025 Financing Financing led by several large dedicated healthcare funds1 Upfront $125.5 M Proceeds from exercise of all warrants following release of VITESSE topl
Slide 7: Significant Market Opportunity for VIASKIN Peanut Patch
Significant Market Opportunity for VIASKIN® Peanut Patch ~670K Children Aged 1-7 Years Have Peanut Allergy in US1-3 1-3 years old 4-7 years old 280,000 Toddlers1-3 390,000 Children1-3 1. CDC National Population Projections 2014-2060 https://wonder.cdc.gov/population-projections-2014-2060.html 2. Gup
Slide 8: VIASKIN Peanut Patch – A Potential Treatment for Peanut Allergy
VIASKIN® Peanut Patch – A Potential Treatment for Peanut Allergy That Can Be Easily Incorporated into the Busy Lives of Families Potential Benefits of Epicutaneous Immunotherapy with VIASKIN® Peanut Patch Applied at home, once a day onto child’s back VIASKIN® Peanut patch harnesses the No treatment
Slide 9: Square & Circular VIASKIN Peanut Patches Are Separate Product Candidates
Square & Circular VIASKIN® Peanut Patches Are Separate Product Candidates – Two Distinct Opportunities in US Independent Clinical & Regulatory Paths for VIASKIN® Peanut Patch in Toddlers 1–3 YO & Children 4–7 YO Square Patch Circular Patch 1-3 YO 4-7 YO Target Age Overlay Size 34 mm/side 44 mm diame
Slide 10: Accelerated Timeline for VIASKIN Peanut in Children, Ages 4-7 YO
Accelerated Timeline for VIASKIN Peanut in Children, Ages 4 ─7 YO Agreement with FDA on Safety Exposure Data for BLA Filing, Obviating Need for COMFORT Children Trial Anticipated BLA submission in H1’262 ; BLA may be eligible for priority review* DBV anticipates this path may accelerate potential la
Slide 11: US Regulatory Pathway for VIASKIN Peanut in Toddlers, Ages 1-3 YO
US Regulatory Pathway for VIASKIN Peanut in Toddlers, Ages 1 ─3 YO Agreement with FDA on a Formalized Accelerated Approval (AA) Pathway for Toddlers Program1 BLA for 1-3 YO under formal AA pathway anticipated to be submitted in 2H265 DBV has received written confirmation from FDA regarding study cri
Slide 12: EMA Provided Guidance for Marketing Authorization Application
EMA Provided Guidance for Marketing Authorization Application (MAA) for the Circular VIASKIN® Peanut Patch in 1-7 Year Olds The unmet need for peanut allergy in Europe is significant: ▪ Estimated that 615,000 children ages 1 – 7 YO in the EU have peanut allergy1 ▪ Incidence of new diagnosis of ~81,0
Slide 13: There Are Multiple Unmet Needs Concerning the Management of Peanut Allergy
For Many Families, Avoidance Is Not Enough • Accidental exposures still happen despite families’ best efforts1 • In a follow-up, prospective study, approximately 41% of peanut-allergic children reported an accidental exposure within 3 years of diagnosis2 Reactions Are Unpredictable • Reactions to pe
Slide 14: Current Treatment Options Are Often Not Ideal for Patients & Their Families
Current Treatment Options Are Often Not Ideal for Patients & Their Families1-4 Oral Immunotherapy (Approvedⱡ & Non-Proprietary) Omalizumab (anti-IgE Monoclonal Antibody)ⱡⱡ Complex dose escalation schedule, requiring multiple Fear of injection: visits to an allergist’s office that can each last >1 ho
Slide 15: Treatment Must Be Effective, Safe, and Practical to Use
Treatment Must Be Effective, Safe, and Practical to Use to Achieve Outcomes with Immunotherapy 1. Greenhawt M, et al. Ann Allergy Asthma Immunol. 2018;120:620-625. doi:10.1016/j.anai.2018.03.001; 2. Based on primary market research conducted on behalf of DBV among 100 allergists in the United States
Slide 16: Anticipated Near-Term Milestones
Anticipated Near-Term Milestones Upcoming Milestones & Catalysts Anticipated Over Next 18 Months CHILDREN (4-7 years) VITESSE topline data anticipated in Q4 2025 BLA submission for 4-7 YO anticipated for 1H 20261 TODDLERS (1-3 years) Initiation of COMFORT Toddlers safety trial anticipated in Q2 2025
Slide 17: The Science of Epicutaneous Immunotherapy (EPIT)
THE SCIENCE OF EPICUTANEOUS IMMUNOTHERAPY (EPIT) 17
Slide 18: EPIT Aims to Re-educate the Immune System Thus Suppressing the Allergic Response
Epicutaneous Immunotherapy (EPIT) Aims to Re-educate the Immune System Thus Suppressing the Allergic Response1-7 Regulatory T Cells act on the immune system to Antigen Presenting Cells suppress the allergic response EPIT delivers allergen capture allergen and induce to the skin unique Regulatory T C
Slide 19: VIASKIN Patch: Our Innovative Approach to Epicutaneous Immunotherapy
VIASKIN® Patch: Our Innovative Approach to Epicutaneous Immunotherapy1-3 A Novel Drug-Device Combination for Delivering Allergen Immunotherapy Adhesive Overlay PET Titanium Backing Condensation Chamber Allergen Adhesive Crown Condensation Chamber Allergen Solubilization formed by adhesive crown, all
Slide 20: VIASKIN Patch Uses Minimal Amounts of Allergen to Induce Desensitization
VIASKIN® Patch Uses Minimal Amounts of Allergen to Induce Desensitization1-3 1/1000th of a peanut is applied daily to the skin Allergen 3 years of treatment with VIASKIN® Peanut patch (250 µg) is equivalent in exposure VIASKIN® Patch amount to 1 peanut kernel Solubilized allergen is captured by spec
Slide 21: Desensitization is Measured by Increases in Eliciting Dose
Desensitization is Measured by Increases Decrease in Reaction Risk with Increased in Eliciting Dose (ED) ED Following Allergen Immunotherapy ED = the amount of allergen that induces allergic symptoms1: SKIN: erythematous rash, scratching, hives, lip or face swelling UPPER RESPIRATORY: sneezing/itchi
Slide 22: VIASKIN Peanut Program in Children Ages 4-7 Years Old
VIASKIN® Peanut Program in Children Ages 4-7 Years Old DBV Technologies | Corporate Overview
Slide 23: VITESSE Study Design
VITESSE Study Design Targeting a Younger, More Sensitive Patient Population1 ▪ Fully enrolled since end of Q3 20242 → 654 subjects ages 4-7 YO (vs target enrollment of 6003) ▪ Largest immunotherapy clinical trial for this patient population2 Global Phase 3 Trial Randomized, double-blind, placebo-con
Slide 24: Key Design Elements of the VITESSE Study
Key Design Elements of the VITESSE Study Targeted a younger, more sensitive population More malleable immune systems that can be relative to previous 4-11 YO indication1 more easily re-educated with immunotherapy2,3 as assessed in Phase 3 pivotal trial, PEPITES Lowered baseline entry OFC to 100 mg M
Slide 25: Statistical Definition of a Responder Reflects a More Sensitive Population
Statistical Definition of a Responder Reflects a More Sensitive Population Enrolled in VITESSE Responder Criteria Changed to Reflect a Younger, More Sensitive Population 1 Baseline 1 mg 3 mg 10 mg 30 mg 100 mg 300 mg 1 mg 3 mg 10 mg 30 mg 100 mg Month 12 1 mg 3 mg 10 mg 30 mg 100 mg 300 mg 1000 mg 1
Slide 26: VITESSE Study Fully Enrolled as of August, 2024
VITESSE Study Fully Enrolled as of August, 20241 DBV’s original statistical calculations had at least 654 subjects enrolled: power >90% 90% power with 600 randomized subjects 57% of enrolled subjects are aged 4-5 YO2 Younger patients tend to respond better2 (43% of cohort = 6-7 YO) Overall randomize
Slide 27: VIASKIN Peanut Program in Toddlers (1–3-Year-Olds)
VIASKIN® Peanut Program in Toddlers (1–3-Year-Olds) DBV Technologies | Corporate Overview
Slide 28: Positive Results from Phase 3 EPITOPE Study
Positive Results from Phase 3 EPITOPE Study with Primary Endpoint Met & with a Favorable Safety & Tolerability Profile PRIMARY ENDPOINT MET 1-3 OTHER ENDPOINTS 1-3 SAFETY 1-3 67.0% of participants 64.2% of participants reached an ED VP250 was well-tolerated, on VP250 were of ≥1000 mg (equivalent of
Slide 29: Phase 3 EPITOPE: VIASKIN Peanut Patch in Toddlers 1-3 Years of Age
Phase 3 EPITOPE: VIASKIN® Peanut Patch in Toddlers 1-3 Years of Age Study Design for EPITOPE Pivotal Global Study1 & Open-Label Extension (OLE) to EPITOPE Study2 EPITOPE Open-Label Extension (“EPOPEX”) High % of subjects opted to stay on VP250 VP250 VP250 after Year 1 EPITOPE through 36 Months3,4 n=
Slide 30: VIASKIN Peanut Patch Demonstrated a Statistically Significant Treatment Effect in Toddlers
VIASKIN® Peanut Patch Demonstrated a Statistically Significant Treatment Effect in Toddlers After 12 Months1,2 †† ED ≥ 1000 mg † Treatment Responders 80% 80% (Equivalent of ~3-4 peanuts) P<0.001 70% 70% P<0.001 Percent of Participants with ED 67.0% 60% 60% 64.2% Percent of Responders (%) ≥1,000 mg a
Slide 31: EPITOPE Open-Label Extension Shows Continued Improvement Through 36 MO
Data from EPITOPE Open-Label Extension Show Continued Improvement in Treatment Response in Toddlers Through 36 MO1-4 • 175 subjects entered OLE study (out of 244 randomized to receive VP250 in EPITOPE) • 166 subjects (95%) of those in the OLE underwent DBPCFC at Month 24 • 149 subjects (85%) underwe
Slide 32: EPITOPE Open-Label Extension Shows Continued Improvement Through 36 MO
Data from EPITOPE Open-Label Extension Show Continued Improvement in Treatment Response in Toddlers Through 36 MO1-3 Eliciting Dose ≥2000 mg Completed Food Challenge* Without (Equivalent of 6-8 peanuts) Meeting Stopping Criteria *3444 mg cumulative dose consumed Percentage of Participants Percentage
Slide 33: Consistently Favorable Safety & Tolerability Profile in Toddlers
Study Results of VIASKIN® Peanut Patch Consistently Demonstrate a Favorable Safety & Tolerability Profile in Toddlers1-4 Frequency of Treatment-Related Local Skin Reactions Are Further Reduced After 3 Years of Treatment • Consistent with other studies5, local Year 1† Year 2 Year 3 application site r
Slide 34: Accelerated Approval Pathway for VIASKIN Peanut Patch in Toddlers
Accelerated Approval Pathway for VIASKIN® Peanut Patch in Toddlers FDA Accelerated Approval Pathway to Licensure Designed to Facilitate & Expedite Promising Therapies Current FDA Guidance for Accelerated Approval (AA) FDA Confirms an AA Pathway for Includes 3 Qualifying Criteria: VIASKIN® Peanut Pat
Slide 35: Alignment on COMFORT Toddlers Supplemental Safety Study
Alignment on COMFORT Toddlers Supplemental Safety Study Intends to Generate Supplemental Safety Data in Peanut Allergic Toddlers, Ages 1-3 YO ▪ 6-month study with an optional 18-month open-label extension ▪ Anticipate enrolling 480 subjects, randomized 3:1 (active: placebo) ▪ Key study inclusion cri
Slide 36: Proposed Labeling Approach to FDA Based on Early Wear-Time Experience
Proposed Labeling Approach to FDA Based on Early Wear-Time Experience in 1–3-Year-Old Subjects in EPITOPE Question was raised by FDA during dialogue re. COMFORT Toddlers’ protocol: What should prescribers tell their patients if there is day-to-day variability in patch wear time? I.e., What will the
Slide 37: Two Groups of Subjects Are Distinguished by This Labeling Approach
Two Groups of Subjects Are Distinguished by This Labeling Approach ~70% of Subjects Experienced LOW Day-to-Day Variability Consistently Achieving ≥20 Hours ADWT Versus ~30% of Participants with HIGH Day-to-Day Variability (<20 Hours ADWT)1,2 Median (IQR) & Mean of Daily Duration LOW day-to-day wear
Slide 38: Similar Wear-Time Experience in Participants Achieving ≥20 Hours ADWT as Placebo
Similar Wear-Time Experience Observed in Participants Achieving ≥20 hours ADWT as Placebo Subjects1,2 Higher Tolerability to Peanut Allergen in Those Subjects Achieving ADWT ≥20 hours =IQR Band (VP250 >20h ADWT) Median (IQR) of Daily Duration of Patch Application (hours) =IQR Band (Placebo) VP250 22
Slide 39: Subjects with Higher Average Daily Wear-Time Are Better Responders at Month 12
Subjects with Higher Average Daily Wear-Time (ADWT ≥20 Hours) Are Better Responders at Month 12 (1,2) Responder Primary Analysis Eliciting Dose ≥1000 mg Eliciting Dose ≥2000 mg (Equivalent of 3-4 peanuts) (Equivalent of 6-8 peanuts) *p <0.01 p <0.01 Percentage of Participants Percentage of Participa
Slide 40: Similar Baseline Characteristics Between the Two Groups Regardless of ADWT
Similar Baseline Characteristics Between the Two Groups of Subjects at Treatment Initiation Regardless of ADWT Lower Tolerability to Peanut Allergen (“More Itchiness”) Observed in Subjects with ADWT <20h1-2 ≥20h ADWT <20h ADWT Baseline characteristics & in-study factors which may influence system we
Slide 41: Lower Rate of Key Safety Outcomes in Subjects with ADWT ≥20 Hours
Lower Rate of Key Safety Outcomes in Subjects with ADWT ≥20 Hours Versus Subjects with ADWT of ≤20 Hours1,2 12-MO Safety Outcomes in VP250 Subjects According to ADWT During First 90 Days of Treatment ADWT ≥20h ADWT <20h TEAE, n (%) (n=167) (n=77) TEAEs (mean) 45.0 44.7 Treatment-related TEAEs leadin
Slide 42: Summary – Optimizing Patch User Experience Based on Patch Wear-time
SUMMARY – Optimizing Patch User Experience Based on Patch Wear-time in Toddlers, Ages 1-3 YO • ADWT within the first 90 days of treatment is highly predictive of clinical efficacy at month 12: o 75.7% of subjects with an ADWT ≥20h were treatment responders (vs 67.0% of all EPITOPE subjects)3 o 47.3%
Slide 43: Our Long-Term Vision is to Realize the Full Potential of the VIASKIN Patch Technology
Our Long-Term Vision is to Realize the Full Potential of the VIASKIN® Patch Technology Program Discovery Pre-clinical Phase 1 Phase 2 Phase 3 VIASKIN® Milk Patch (DBV135) – Cow’s Milk Allergy; MILES: Ages 2-17 years1 VIASKIN® Milk Patch (DBV135) – Eosinophilic Esophagitis; SMILEE: Ages 4-17 years2 A
Slide 44: Robust Intellectual Property Portfolio
Robust Intellectual Property Portfolio IP Protection in Various Countries, Encompassing: Core patch technology Condensation chamber Epicutaneous immunotherapy (EPIT) activates the immune system by allowing the Mechanism of action antigen to penetrate the upper layer of the epidermis (intact skin) Ma
Slide 45: Patch Manufacturing Capabilities
Patch Manufacturing Capabilities Integrated End-to-End Patch Manufacturing in Place Source Material Active Pharmaceutical Ingredient (API) Final Product Process Proprietary electrospray technology deposits a precise antigen dose without any adjuvant on a PET titanium backing film DBV Technologies |
Slide 46: Appendix I: Legacy Phase 3 Studies in Children Ages 4-11 Years Old
APPENDIX I: Legacy Phase 3 Studies in Children Ages 4-11 Years Old
Slide 47: VIASKIN Peanut Patch Clinical Development Program in 4–11-Year-Olds
VIASKIN® Peanut Patch Clinical Development Program in 4–11-Year-Olds Efficacy & Safety Data From Completed Phase 3 Studies in Children Aged 4-11 Years Supported Progression of Program to Younger Age Groups Open-Label LT Follow-up CHILDREN (4-11 years) 356 patients 298 patients 393 patients Square (O
Slide 48: Phase 3 PEPITES/PEOPLE: VIASKIN Peanut Patch 250 µg in Children 4–11 YO
Phase 3 PEPITES/PEOPLE: VIASKIN® Peanut Patch 250 µg in Children 4–11 YO Results Published in JAMA (PEPITES)1 & Journal of Allergy & Clinical Immunology (PEOPLE)2 VIASKIN Peanut VIASKIN Peanut Global Phase 3 Trial Randomized, double-blind, placebo-controlled 250 µg 250 µg M36 356 patients* aged 4-11
Slide 49: VIASKIN Peanut Patch Achieved Clinically Meaningful Changes in Eliciting Dose After 1 Year
VIASKIN® Peanut Patch Treatment Achieved Clinically Meaningful Changes in Eliciting Dose (ED) After 1 Year Primary Efficacy Outcome Showed Statistically Significant Treatment Benefit Response Rate after 12 Months Change in Eliciting Dose after 12 Months* 50% 100% 28.0% Percent of Responders (%) P<0.
Slide 50: Post-Hoc Analysis of PEPITES Data in Younger Versus Older Children
Post-Hoc Analysis of PEPITES Data Supports Concept That Greater Gains in Desensitization May Be Achieved in Younger Versus Older Children1 Treatment Responders Children Ages 4-7 Years By post hoc analysis, a larger treatment effect in subjects aged 4–7 years 50% P<0.001 who received VIASKIN® Peanut
Slide 51: Pooled Safety Data from Phase 3 Studies of VIASKIN Peanut Patch
Pooled Safety Data from Phase 3 Studies of VIASKIN® Peanut Patch1 749 Subjects Included in the Overall Pooled Safety Analyses, Including 630 Subjects Treated with VIASKIN® Peanut Patch 250 μg for up to 36 Months 749 Subjects from Months 0–6 (Randomized Double-Blind Placebo-Controlled Treatment Perio
Slide 52: REALISE: Study Design and Results from Long-term Safety Study
REALISE: Study Design and Results from Long-term Safety Study Children 4–11 Years Old REALISE Phase 3 Randomized, double-blind, Placebo placebo-controlled VP250 393 patients aged 4–11 years with history Safety checkpoint Safety checkpoint Safety checkpoint of IgE-mediated reactions to peanut, VP250
Slide 53: Appendix II: VIASKIN Peanut Program in Toddlers (1–3-Year-Olds)
APPENDIX II: VIASKIN Peanut Program in Toddlers (1–3-Year-Olds) DBV Technologies | Corporate Overview
Slide 54: Minor Alterations to EPITOPE Patch to Evolve Towards Commercialization
Minor Alterations to EPITOPE Patch to Evolve Towards Commercialization FDA Views the Clinical Patch (Used in EPITOPE) Versus Commercial Patch as Two Different Products Clinical Patch Commercial Patch DBV Technologies | Corporate Overview 54
Slide 55: Investor Relations, Public Relations and Media, Partnering and Licensing
Investor Relations Katie Matthews +1 857-529-2563 katie.matthews@dbv-technologies.com Public Relations and Media Angela Marcucci +1 646-842-2393 angela.marcucci@dbv-technologies.com Partnering and Licensing generalinquiries@dbv-technologies.com Clinical Trial Participation clinicaltrials@dbv-technol