Dbv Technologies Sa · EURONEXT:DBV

Dbv Technologies Sa — Investor Presentation (November 2024)

47 slides from Dbv Technologies Sa's investor presentation, November 2024

  1. Slide 1: DBV Technologies Corporate Presentation November 2024

    DBV TECHNOLOGIES Corporate Presentation I November 2024 © 2024, DBV Technologies. All rights reserved Euronext Paris: DBV I Nasdaq: DBVT

  2. 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 outcome or success of DBV’s clinical trials; design of DBV’s anticipated clinical trials; its ability to suc

  3. Slide 3: DBV Technologies: Developing Novel Treatments for Pediatric Food Allergy

    DBV Technologies: Developing Novel Treatments for Pediatric Food Allergy Deep roots in food allergy Committed to transforming lives of children & families living with the daily burden of food allergy Pioneered VIASKIN® patch technology DBV’s novel approach to epicutaneous immunotherapy VIASKIN® pean

  4. Slide 4: Experienced Management Team & Renowned International Board of Directors

    Company is Led By An Experienced Management Team & Renowned International Board of Directors Executive Team Daniel Tassé Pharis Mohideen Virginie Boucinha Kevin P. Malobisky Robert Pietrusko Caroline Danière Michele F. Robertson Pascal Wotling Chief Executive Officer Chief Medical Officer Chief Fina

  5. Slide 5: ~670K Children Ages 1 to 7 Years-Old Have Peanut Allergy in The US

    ~670K Children Ages 1 to 7 Years-Old Have Peanut Allergy in The US1-3 Approximately 75% will not outgrow their allergy4,5 1-3 years old 4-7 years old 280,000 Toddlers2,3 390,000 Children2,3 1. CDC National Population Projections 2014-2060 https://wonder.cdc.gov/population-projections-2014-2060.html

  6. Slide 6: Square and Circular VIASKIN Peanut Patches Are Separate Product Candidates

    Square (Original) and Circular (Modified) VIASKIN® Peanut Patches Are Separate Product Candidates Independent Clinical & Regulatory Paths for VIASKIN® Peanut Patch in Toddlers 1–3 YO & Children 4–7 YO in USA Square Patch Circular Patch (Original) (Modified) Target Age 1-3 years old 4-7 years old Ove

  7. Slide 7: Two Distinct Opportunities for VIASKIN Peanut with Independent Regulatory Pathways

    Two Distinct Opportunities for VIASKIN Peanut in Toddlers & Children with Independent Regulatory Pathways † To bring the total number of participants on active treatment close to 600, per ICH guidelines. 1. DBV Technologies Press Release. October 22, 2024; 2. DBV Technologies Press Release. April 19

  8. Slide 8: EMA Provided Guidance for Marketing Authorization Application in 1-7 Year Olds

    EMA Provided Guidance for Marketing Authorization Application for VIASKIN Peanut in 1-7 Year Olds With Circular (Modified) Patch ▪ 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 o

  9. Slide 9: 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

  10. Slide 10: Current Treatment Options are Often Not Ideal For Many Patients & Families

    Current Treatment Options are Often Not Ideal For Many 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

  11. Slide 11: Treatment Goals of Physicians, Patients & Their Caregivers

    Treatment Goals of Physicians, Patients & Their Caregivers Needs of Physicians, Patients Goals for New Peanut Allergy & Their Caregivers/Families Treatments ▪ 90% of allergists see the need for additional options The goals of peanut allergy treatment aim to maximize in the treatment of pediatric pea

  12. Slide 12: VIASKIN Peanut Patch – A Potential Treatment That Fits Into Busy Family Lives

    VIASKIN® Peanut Patch – A Potential Treatment for Peanut Allergy That Can Be Incorporated Into The Busy Lives of Families Potential Benefits of Epicutaneous Immunotherapy VIASKIN peanut is designed to meet treatment with VIASKIN® peanut patch goals of patients, caregivers & clinicians Applied at hom

  13. Slide 13: Increasing Interest in VIASKIN Peanut Patch In a Growing Competitive Landscape

    Increasing Interest in VIASKIN® Peanut Patch In a Growing Competitive Landscape 3 invited review articles published in top allergy journals in 2024 alone1-3 Record-breaking attendance at 2024 AAAAI product theatre on early intervention with VIASKIN® peanut patch DBV hosted Product Theater “The Impor

  14. Slide 14: VIASKIN Peanut Patch May Provide a Tailored Solution to Many Peanut Allergic Children

    VIASKIN® Peanut Patch May Provide a Tailored Solution to a Large Number of Peanut Allergic Children Ages 1-7 YO, if Approved Potential multi-billion-dollar U.S. market opportunity ~29.1 million children in US, ages 1-71 2.2% Incidence of peanut allergy has increased Prevalence2 over recent decades w

  15. Slide 15: EPIT Aims To Re-educate the Immune System by Suppressing the Allergic Response

    Epicutaneous Immunotherapy (EPIT) Aims To Re-educate the Immune System by 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 Cel

  16. Slide 16: 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, alle

  17. Slide 17: VIASKIN Uses Minimal Amounts of Allergen to Induce an Immune Response

    VIASKIN Uses Minimal Amounts of Allergen to Induce an Immune Response1-3 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 speciali

  18. Slide 18: Allergic Reactions Determined by Relationship Between Eliciting Dose and Exposure Dose

    Occurrence of Allergic Reactions is Determined by the Relationship Between Eliciting Dose and Exposure Dose Eliciting Dose Exposure Dose Reaction Prediction The amount of allergen that induces The amount of allergen accidentally An allergic reaction is predicted to occur unmistakable allergic sympto

  19. Slide 19: Modeling Data Suggest Increasing Eliciting Dose Decreases Risk of Allergic Reaction

    Decrease in Reaction Risk Modeling* data suggest increasing a Following Allergen Immunotherapy patient’s eliciting dose decreases the ED after allergen risk of an allergic reaction1 immunotherapy 1,000 mg ED after allergen 300 mg 300 mg immunotherapy ED before allergen immunotherapy 100 mg 30 mg ED

  20. Slide 20: Generating Robust Data in Peanut-Allergic Toddlers & Children

    Generating Robust Data in Peanut-Allergic Toddlers (Ages 1-3 YO) & Children (Ages 4-7 YO) Recently Completed, Currently Ongoing & Planned Phase 3 Clinical Trials with VIASKIN® Peanut Patch* 1-3 years of age Open-Label Extension 1-3 years of age TODDLERS (1-3 years) 362† patients 304 patients ~400 pa

  21. Slide 21: VIASKIN Peanut Program in Toddlers (1–3-Year-Olds)

    VIASKIN Peanut Program in Toddlers (1–3-Year-Olds)

  22. Slide 22: Positive Results from Phase 3 EPITOPE Study

    Positive Results from Phase 3 EPITOPE Study With Primary Endpoint Met & With Favorable Safety & Tolerability Profile PRIMARY ENDPOINT MET 1-3 OTHER ENDPOINTS 1-3 SAFETY 1-3 67% of participants on 64.2% of participants reached an ED VP250 was well-tolerated, VP250 were responders of ≥1000 mg (equival

  23. Slide 23: Phase 3 EPITOPE: VIASKIN Peanut 250 µg in Toddlers 1-3 Years of Age

    Phase 3 EPITOPE: VIASKIN Peanut 250 µg in Toddlers 1-3 Years of Age Study Design for EPITOPE Pivotal Global Study1 & Open-Label Extension to EPITOPE Study2 EPITOPE Open-Label Extension (“EPOPEX”) VP250 VP250 n=244 n=175 n=166 Month 12 Month 24 Month 36 ▲ ▲ ▲ ▲DBPCFC = Double-Blind Randomized Placebo

  24. Slide 24: VIASKIN Peanut Patch Demonstrated Statistically Significant Treatment Effect in Toddlers

    VIASKIN® Peanut Patch Demonstrated a Statistically Significant Treatment Effect in Toddlers After 12 MO1,2 †† ED ≥ 1000 mg † Treatment Responders 80% (Equivalent of ~3-4 peanuts) 80% P<0.001 70% P<0.001 70% Percent of Participants with ED 67.0% 60% 64.2% 60% Percent of Responders (%) ≥1,000 mg at M1

  25. Slide 25: Interim EPITOPE Open-Label Extension Data Show Continued Improvement After 24 Months

    Interim Data from EPITOPE Open-Label Extension Show Continued Improvement in Treatment Response in Toddlers After 24 MO1 Treatment Responders† Eliciting Dose ≥1000 mg Completed Food Challenge* Without (Equivalent of 3-4 peanuts) Meeting Stopping Criteria Percentage of participants (%) Percentage of

  26. Slide 26: Favorable Safety & Tolerability Profile in Toddlers

    Study Results of VIASKIN® Peanut Patch Consistently Demonstrate A Favorable Safety & Tolerability Profile in Toddlers1,2 • Consistent with other studies3, local First Year Second Year First Year application site reactions were the most of Active of Active of Active reported adverse event; however, t

  27. Slide 27: Regulatory History for VIASKIN Peanut Patch in Toddlers [I/II]

    Regulatory History for VIASKIN® Peanut Patch in Toddlers [I/II] Pre-BLA Type B Meeting Written Written Responses Received to DBV’s Clarification Request Re. Further discussions between FDA Responses from FDA1 • FDA confirmed EPITOPE data met pre- COMFORT Studies Design3 & DBV regarding COMFORT speci

  28. Slide 28: Regulatory History for VIASKIN Peanut Patch in Toddlers [II/II]

    Regulatory History for VIASKIN® Peanut Patch in Toddlers [II/II] FDA offered guidance on the intermediate clinical endpoint DBV proposed to FDA a “label-in/label-out” approach1: (ICE) to satisfy the 3rd criterion2: ▪ Crafted on post-hoc analysis of EPITOPE efficacy & wear DBV agreed in informal disc

  29. Slide 29: FDA Provided Guidance to Pursue An Accelerated Approval Pathway in Toddlers

    FDA Provided Guidance to Pursue An Accelerated Approval Pathway for VIASKIN peanut in Toddlers FDA Accelerated Approval Pathway to Licensure Designed to Facilitate & Expedite Promising Therapies Three criteria must be satisfied to qualify for Accelerated Approval (AA)1: 1 Product treats a serious di

  30. Slide 30: US Regulatory Pathway for Toddlers Ages 1-3 YO

    US Regulatory Pathway for Toddlers Ages 1-3 YO FDA provided guidance to Accelerated Approval Pathway for Toddlers Program1 FDA Guidance to Accelerated Approval Pathway† 1 2 Could constitute Commitment to a a BLA Post-Marketing 6-Month DBPC submission for a Confirmatory COMPLETED Efficacy & Safety Su

  31. Slide 31: VIASKIN Peanut Program in Children Ages 4-7 Years Old

    VIASKIN Peanut Program in Children Ages 4-7 Years Old 31

  32. Slide 32: VIASKIN Peanut Program in Children 4 Years and Older

    VIASKIN Peanut Program in Children 4 Years and Older Phase 3 Efficacy & Safety Study (VITESSE) Based on Prior Phase 3 Study Conducted in 4-11 YO VITESSE IS ASSESSING VITESSE MODELED ON EFFICACY & SAFETY OF THE MODIFIED PATCH PRIOR PHASE 3 PIVOTAL TRIAL IN 4-11 YO4 ✓ VIASKIN® peanut patch (VP250) was

  33. Slide 33: VITESSE Study Design Schematic with Open-Label Extension

    VITESSE Study Design Schematic with Open-Label Extension Targeting a Younger, More Sensitive Patient Population1 ▪ VITESSE Phase 3 is the largest immunotherapy clinical trial for this patient population2 ▪ Fully enrolled since end of Q3 20242 (654 participants versus target enrollment of 6003) Globa

  34. Slide 34: US Regulatory Pathway for Children Ages 4-7 Years Old

    US Regulatory Pathway for Children Ages 4-7 Years Old † To achieve FDA Guideline of ~600 subjects on active treatment for at least 6 months 1. DBV Technologies Press Release. September 23, 2024. DBV Technologies | Corporate Overview 34 2. DBV Technologies Press Release. October 22, 2024.

  35. Slide 35: 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 (DBV135) – Cow’s Milk Allergy MILES: Ages 2-17 years1 VIASKIN milk (DBV135) – Eosinophilic Esophagitis SMILEE: Ages 4-17 years2 Autoimmune and Inf

  36. Slide 36: 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

  37. Slide 37: 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 |

  38. Slide 38: Anticipated Near-Term Milestones

    Anticipated Near-Term Milestones Upcoming Milestones & Catalysts Anticipated Over Next 12 Months TODDLERS (1-3 years) Formalize Accelerated Approval Pathway per FDA guidance Initiation of COMFORT Toddlers safety trial anticipated in Q2 2025 End-of-Study results from the Open-label Extension to EPITO

  39. Slide 39: Investment Highlights (US)

    Investment Highlights (US) Two Distinct Opportunities Clear Clinical Pathway for Anticipated Clinical & Financial Position for TwoVIASKIN® peanut patch Distinct Opportunities Both Programs Regulatory Milestones One BLA in 1–3-year-olds 1–3-year-olds 1–3-year-olds with SQUARE (Original) EPITOPE (DBV’

  40. Slide 40: APPENDIX: Legacy Phase 3 Studies in Children Ages 4-11 Years Old

    APPENDIX: Legacy Phase 3 Studies in Children Ages 4-11 Years Old

  41. Slide 41: VIASKIN Peanut Clinical Development Program in 4–11-Year-Olds

    VIASKIN Peanut 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 (Original

  42. Slide 42: Phase 3 PEPITES/PEOPLE: VIASKIN Peanut 250 µg in Children 4–11 YO

    Phase 3 PEPITES/PEOPLE: VIASKIN Peanut 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 years;

  43. Slide 43: VIASKIN Peanut Achieved Clinically Meaningful Changes in Eliciting Dose After 1 Year

    VIASKIN Peanut 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<0.001 Per

  44. Slide 44: Post-Hoc Analysis of PEPITES Data in Younger vs Older Children

    Post-Hoc Analysis of PEPITES Data Supports Concept That Greater Gains in Desensitization May be Achieved in Younger vs 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 250

  45. Slide 45: Pooled Safety Data from Phase 3 Studies of VIASKIN Peanut

    Pooled Safety Data from Phase 3 Studies of VIASKIN Peanut1 749 subjects included in the overall pooled safety analyses, including 630 subjects treated with VIASKIN® Peanut 250 μg for up to 36 months 749 Subjects from Months 0–6 (Randomized Double-Blind Placebo-Controlled Treatment Period) • Serious

  46. Slide 46: REALISE: Study Design and Results from Long-term Safety Study

    REALISE: Study Design and Results from Long-term Safety Study Children 4–11 years REALISE Phase 3 Randomized, double-blind, Placebo placebo-controlled VP250 µg 393 patients aged 4–11 years with history Safety checkpoint Safety checkpoint Safety checkpoint of IgE-mediated reactions to peanut, VP250 µ

  47. Slide 47: Investor Relations and Media Contacts

    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

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