Dbv Technologies Sa · EURONEXT:DBV
Dbv Technologies Sa — Investor Presentation (September 2023)
44 slides from Dbv Technologies Sa's investor presentation, Sep 8, 2023
Slide 1: DBV Technologies Corporate Presentation September 2023
DBV TECHNOLOGIES Corporate Presentation I September 2023 Euronext Paris: DBV I Nasdaq: DBVT
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation contains forward looking statements including, but not limited to, statements concerning the outcome or success of DBV’s clinical trials; its ability to successfully gain regulatory approvals and commercialize products; its ability to successfully advance its
Slide 3: Investment Highlights
Investment Highlights Two Distinct Opportunities Clear Clinical Pathway for Anticipated Clinical & Financial Position Twofor Distinct Opportunities Viaskin™ Peanut Both Programs Regulatory Milestones One BLA in 1–3-year-olds 1–3-year-olds 1–3-year-olds with SQUARE (Original) - EPITOPE (Phase 3 Study
Slide 4: Generating Robust Viaskin Peanut Data in Toddlers & Children
Generating Robust Viaskin™ Peanut Data in Toddlers (Ages 1-3 Years Old) & Children (Ages 4-7 Years Old) Recently Completed, Currently Ongoing & Planned Phase 3 Clinical Trials* Viaskin™ Peanut Phase 3 Study Age Group (Program) Patch Type Phase 3 Status EPITOPE (Safety & Efficacy) EPOPEX (Open-Label
Slide 5: Square and Circular Patches Are Separate Product Candidates
Square (Original) and Circular (Modified) Patches Are Separate Product Candidates Independent Clinical and Regulatory Paths for Viaskin™ Peanut in Toddlers 1–3 Years & in Children 4–7 Years Square Patch Circular Patch (Original) (Modified) Target Age 1-3 years old 4-7 years old Overlay Size 34 mm/si
Slide 6: More Children Are Living With Peanut Allergy Than Ever Before
In the US, More Children Are Living With Peanut Allergy Than Ever Before Approximately ~75% will not outgrow their allergy1 1-3 years old 4-7 years old 280,000 Toddlers2,3 390,000 Children2,3 1. Savage J, et al. J Allergy Clin Immunol Pract. 2016;4:196-203. 2. Gupta RS, et al. Pediatrics. 2018;142:e
Slide 7: Multiple Unmet Needs in 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 8: Allergists, Families and Children Want Additional Protection
Caregivers and physicians are seeking a treatment that1,2: • Reduces the likelihood of an allergic reaction in case of accidental exposure • Has a low risk of a serious reaction caused by the treatment and low risk of side effects • Is accepted by the caregiver and child The goals of peanut allergy
Slide 9: Families and Allergists Want Additional Therapy Options
Families and Allergists Want Additional Therapy Options for Peanut Allergy1,3 Oral immunotherapy is often not an ideal option for many patients and their families:1,2 Complex dose escalation schedule, requiring multiple visits to an allergist’s office that can each last more than 1 hour Avoidance of
Slide 10: Target Product Profile for Peanut Allergy Treatment
Target Product Profile: A Treatment for Peanut Allergy That Can Be Incorporated into the Busy Lives of Families Viaskin™ Peanut: No treatment escalation requiring frequent doctor's appointments No increased risk of side effects due to illness, missed sleep, or stress No restriction on activities suc
Slide 11: EPIT Aims To Re-educate the Immune System
Epicutaneous Immunotherapy (EPIT™) Aims To Re-educate the Immune System by Suppressing the Allergic Response1-6 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 Ce
Slide 12: The Viaskin Patch: Innovative Approach to EPIT
The 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,
Slide 13: Viaskin Uses Minimal Amounts of Allergen
Viaskin™ Uses Minimal Amounts of Allergen to Induce an Immune Response1-3 Allergen (green) Solubilized allergen is captured by specialized Antigen Viaskin™ Patch Presenting Cells (Langerhans cells) in the epidermis Langerhans cells process the allergen, migrate to the lymph nodes where they present
Slide 14: Allergic Reactions: 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 ingested, An allergic reaction is predicted to occur unmistakable aller
Slide 15: 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 risk ED after allergen 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
Slide 16: Viaskin Peanut Clinical Development Program
Viaskin™ Peanut Clinical Development Program Multiple Phase 3 Studies in Toddlers (Ages 1-3 Years) & in Children (Ages 4-7 Years) 1-3 years of age Open-Label LT Follow-up 1-3 years of age TODDLERS (1-3 years) 362* patients 304 patients ~400 patients Square (Original) Patch 12 months DBPC 36 months 6
Slide 17: Viaskin Peanut Program in Toddlers (1–3-Year-Olds)
Viaskin™ Peanut Program in Toddlers (1–3-Year-Olds)
Slide 18: Phase 3 EPITOPE: Viaskin Peanut 250 µg in Toddlers
Phase 3 EPITOPE: Viaskin™ Peanut 250 µg in Toddlers 1-3 Years of Age Results Published in NEJM in May 20231 & Presented at The American College of Allergy, Asthma and Immunology Meeting in November 20222 Pivotal Global Phase 3 Trial Viaskin Peanut Randomized, double-blind, placebo-controlled 250 µg
Slide 19: Viaskin Peanut Demonstrated Statistically Significant Treatment Effect
Viaskin™ Peanut Demonstrated a Statistically Significant Treatment Effect1,2 80% 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 M12 (%) Δ= 33.4% 50% Δ= 34.7% 50% (95% CI: 22.4, 44.5) (95% CI: 23.6, 45.7) 40% 40% 30% 30% 33.5% 29
Slide 20: EPITOPE Results Published in NEJM
Phase 3 EPITOPE: Viaskin™ Peanut 250 µg in Toddlers 1-3 Years Of Age Results Published in NEJM May 11, 20231 LINK to NEJM ARTICLE LINK to NEJM EDITORIAL: Phase 3 Trial of Epicutaneous Immunotherapy in Good News for Toddlers with Peanut Allergy Toddlers with Peanut Allergy LINK to NEJM VIDEO highligh
Slide 21: Shift Toward Reduction in Symptom Severity After 12 Months
Shift Toward Reduction in Symptom Severity Following 12 Months of Viaskin™ Peanut Treatment1,2 Maximum Symptom Severity at Month 12 DBPCFC At baseline double-blind, placebo-controlled food challenge 100% (DBPCFC), the proportions of maximum symptom severity 23.0% 12.5% 25.5% 28.6% were balanced betw
Slide 22: EPITOPE Safety Summary
EPITOPE Safety Summary1,2 Safety Profile Consistent with Prior Viaskin™ Peanut Studies VP250 vs Placebo Local Application Site Reactions: primarily mild to moderate that decreased in frequency with time 99.6% vs 94.1% Serious Adverse Events 8.6% vs 2.5% Serious Adverse Events related to IMP: 1 case
Slide 23: Regulatory Pathway for Viaskin Peanut in Toddlers Outlined
Regulatory Pathway for Viaskin™ Peanut in Toddlers Outlined No Requirement from FDA for Additional Efficacy Study – Supplemental Safety Trial To Be Initiated April 2023: Pre-BLA Type B Meeting Written Responses from FDA1 ✓ FDA did not request an additional efficacy study in 1-3-year-olds – primary e
Slide 24: Next Steps To Advance Viaskin Peanut Toddlers Program
Next Steps To Advance Viaskin™ Peanut Toddlers Program Seek Alignment with FDA on Final Protocol Before Initiation of COMFORT Toddlers Finalization of COMFORT Toddlers protocol DBV expects to submit the final COMFORT Toddlers protocol to the FDA to seek final alignment prior to commencing COMFOR
Slide 25: Viaskin Peanut Program in Children (4-7-Year-Olds)
Viaskin™ Peanut Program in Children (4-7-year-Olds) 25
Slide 26: Regulatory History for Viaskin Peanut in Children 4 Years and Older
Regulatory History for Viaskin™ Peanut in Children 4 Years and Older Efficacy Study (VITESSE) in Progress – Supplemental Safety Trial (COMFORT Children) To Be Initiated 1 August 2020: FDA Issued a CRL Regarding the BLA for Viaskin™ Peanut in 4-11 Year Olds1 Concerns raised on the impact of patch adh
Slide 27: VITESSE Is Designed for Younger, More Allergen-Sensitive Patients
VITESSE Is Designed for Younger, More Allergen-Sensitive Patients, Ages 4-7 years VITESSE Study Designed to Support the Agency’s Review of a Potential BLA for Viaskin™ Peanut as a Peanut Allergy Treatment* Global Phase 3 Trial Viaskin™ Peanut Randomized, double-blind, placebo-controlled 250 µg ~600
Slide 28: Regulatory Path for Viaskin Peanut in Children (4-7 Years) Outlined
Regulatory Path for Viaskin™ Peanut in Children (4-7 Years) Outlined Seek Alignment with FDA on Final Protocol Before Initiation of COMFORT Children Phase 3 Efficacy Study VITESSE in 4–7-year-olds is currently enrolling Finalization of protocol for COMFORT Children DBV expects to submit the fi
Slide 29: Long-Term Vision: Full Potential of the Viaskin Platform
Our Long-Term Vision Is to Realize the Full Potential of the Viaskin™ Platform Program Discovery Pre-clinical Phase 1 Phase 2 Phase 3 Viaskin Milk (DBV135) – Cow’s Milk Allergy MILES: Ages 2-17 years Viaskin Milk (DBV135) – Eosinophilic Esophagitis (EoE) SMILEE: Ages 4-17 years Non-IgE Mediated Cow’
Slide 30: Unlocking the Immune Properties of the Skin with Viaskin Platform
We Aim to Unlock the Powerful Immune Properties of the Skin with our Viaskin™ Platform Proprietary electrospray technology deposits a precise antigen dose without any adjuvant on a PET titanium backing film DBV Technologies | Corporate Overview 30
Slide 31: Patented Patch Manufacturing Capabilities
Patented 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 Techno
Slide 32: Robust Intellectual Property Portfolio
Robust Intellectual Property Portfolio IP Covers: Core patch technology Condensation chamber Epicutaneous immunotherapy (EPIT) activates the immune system by allowing the antigen to Mechanism of action penetrate the upper layer of the epidermis (intact skin) Manufacturing Electrospray patch manufact
Slide 33: $174M in cash and cash equivalents as of June 30, 2023
$174M in cash and cash equivalents as of June 30th, 2023 DBV Technologies | Corporate Overview 33
Slide 34: Anticipated Near-Term Milestones
Anticipated Near-Term Milestones Seek Alignment from FDA on Final COMFORT protocols 2023 Q3 Financial Results Publication of EPITOPE Data Analyses (Including Adhesion Data) Continue to Advance VITESSE Enrollment DBV Technologies | Corporate Overview 34
Slide 35: Investment Highlights
Investment Highlights Two Distinct Opportunities Clear Clinical Pathway for Anticipated Clinical & Financial Position Twofor Distinct Opportunities Viaskin™ Peanut Both Programs Regulatory Milestones One BLA in 1–3-year-olds 1–3-year-olds 1–3-year-olds with SQUARE (Original) - EPITOPE (Phase 3 Study
Slide 36: Investor Relations, Public 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
Slide 37: Appendix: Legacy Phase 3 Studies in Children Ages 4-11
APPENDIX: Legacy Phase 3 Studies in Children Ages 4-11 Years Old
Slide 38: 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 (Origina
Slide 39: Phase 3 PEPITES/PEOPLE: Viaskin Peanut in Children 4–11
Phase 3 PEPITES/PEOPLE: Viaskin™ Peanut 250 µg in Children 4–11 Years Of Age Results published in peer-reviewed publications 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 25
Slide 40: 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 40
Slide 41: Changes in ED Maintained or Improved Over 3 Years
Changes in ED Maintained or Improved Over 3 Years in the Majority of Subjects in the Open-Label Extension Study1 % of Patients 51.8% of subjects reached an ED of ≥1,000 mg at Month 36, c (N=141) compared to 40.4% at Month 12 M0 M12 M36 75.9% of subjects demonstrated an increase in ED from baseline c
Slide 42: Post-Hoc Analysis of PEPITES 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 who 50% P<0.001 received Viaskin™ Peanut 250
Slide 43: 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
Slide 44: REALISE: Study Design and Long-term Safety Results
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 of Safety checkpoint Safety checkpoint Safety checkpoint IgE-mediated reactions to peanut, includ
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