Dbv Technologies Sa · EURONEXT:DBV
Dbv Technologies Sa — Investor Presentation (January 2025)
59 slides from Dbv Technologies Sa's investor presentation, January 2025
Slide 1: DBV Technologies Corporate Presentation January 2025
DBV TECHNOLOGIES Corporate Presentation I January 2025 © 2024, DBV Technologies. All rights reserved 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 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
Slide 3: 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
Slide 4: Investment Highlights (US)
Investment Highlights (US) Two Distinct Opportunities Clear Clinical Pathway for Anticipated Clinical & Financial Position for VIASKIN® Two Peanut Patch Distinct Opportunities Both Programs Regulatory Milestones One BLA in 1–3-year-olds The successful EPITOPE Phase 3 - Initiation of COMFORT study to
Slide 5: Experienced Management Team & 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
Slide 6: ~670K Children Ages 1 to 7 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
Slide 7: 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
Slide 8: Two Distinct Opportunities with Independent Regulatory Pathways
Two Distinct Opportunities for VIASKIN® Peanut Patch in Toddlers & Children with Independent Regulatory Pathways † To bring the total number of participants on active treatment close to 600, per ICH guidelines. WR=Written Response; AA=Accelerated Approval; ICH=International Council for Harmonisation
Slide 9: EMA Guidance for MAA for Circular VIASKIN Peanut Patch
EMA Provided Guidance for Marketing Authorization Application (MAA) for the Circular (Modified) 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 diagnos
Slide 10: 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 11: Current Treatment Options Are Often Not Ideal
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
Slide 12: Treatment Goals of Physicians, Patients & 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
Slide 13: VIASKIN Peanut Patch Can Be Incorporated into Busy Family Lives
VIASKIN® Peanut Patch – A Potential Treatment for Peanut Allergy That Can Be Incorporated into the Busy Lives of Families VIASKIN® Peanut Patch is Designed to Potential Benefits of Epicutaneous Immunotherapy Meet Treatment Goals of Patients, with VIASKIN® Peanut Patch Caregivers & Clinicians Applied
Slide 14: Increasing Interest in VIASKIN Peanut Patch
Increasing Interest in VIASKIN® Peanut Patch in a Growing Competitive Landscape Three 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 I
Slide 15: Potential Multi-Billion-Dollar U.S. Market Opportunity
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 over recent Prevalence2 decades w
Slide 16: EPIT Aims to Re-educate the Immune System
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
Slide 17: VIASKIN Patch: 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 18: VIASKIN Patch Uses Minimal Allergen to Induce Immune Response
VIASKIN® Patch Uses Minimal Amounts of Allergen to Induce an Immune Response1-3 1/1000th of a peanut is applied daily to the skin Allergen VIASKIN® Patch 3 years of treatment with VIASKIN® Peanut patch (250 µg) is equivalent in exposure amount to 1 peanut kernel Solubilized allergen is captured by s
Slide 19: Allergic Reactions Determined by 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
Slide 20: Modeling Data: Increasing Eliciting Dose Decreases Reaction Risk
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 allergen 300 mg 300 mg immunotherapy ED before allergen immunotherapy 100 mg 30 mg ED before
Slide 21: Generating Robust Data in Toddlers and 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† subjects 304 subjects ~480 su
Slide 22: VIASKIN Peanut Program in Toddlers (1–3-Year-Olds)
VIASKIN Peanut Program in Toddlers (1–3-Year-Olds)
Slide 23: Positive Phase 3 EPITOPE Results with Primary Endpoint Met
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 24: Phase 3 EPITOPE: VIASKIN Peanut Patch in Toddlers
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 25: Statistically Significant Treatment Effect in Toddlers After 12 Months
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 26: EPITOPE Open-Label Extension Shows Continued Improvement Through 36 Months
Data from EPITOPE Open-Label Extension Show Continued Improvement in Treatment Response in Toddlers Through 36 Months1-3 • 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%) und
Slide 27: EPITOPE OLE Continued Improvement Through 36 Months (Higher Doses)
Data from EPITOPE Open-Label Extension Show Continued Improvement in Treatment Response in Toddlers Through 36 Months1-3 Eliciting Dose ≥2000 mg Completed Food Challenge* Without (Equivalent of 6-8 peanuts) Meeting Stopping Criteria *3444 mg cumulative dose consumed Percentage of Participants Percen
Slide 28: 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 29: 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 Responses from FDA1 • FDA confirmed EPITOPE data met pre- COMFORT Studies Design3 FDA & DBV regarding specified cri
Slide 30: Regulatory History for VIASKIN Peanut Patch in Toddlers [II/II]
Regulatory History for VIASKIN® Peanut Patch in Toddlers [II/II] DBV proposed to FDA a labeling approach1: FDA offered guidance on the intermediate clinical endpoint ▪ Crafted on post-hoc analysis of EPITOPE efficacy & wear (ICE) to satisfy the 3rd criterion2: time data to bring efficacy as an essen
Slide 31: DBV's Proposed Labeling Strategy
DBV’s Proposed Labeling Strategy A Practical Solution to Address FDA’s Remaining Questions Around Patch Adhesion 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 wi
Slide 32: Two Groups Distinguished by Average Daily Wear-Time
Two Groups of Subjects Treated with VIASKIN® Peanut Patch Are Readily Distinguished Based on Average Daily Wear-Time (ADWT)1,2 ~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) M
Slide 33: Similar Wear-Time Experience in ≥20 Hours ADWT and Placebo
Similar Wear-Time Experience Observed in Participants Achieving ≥20 hours ADWT as Placebo Subjects1,2 IMPLICATION ─ 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 (Pla
Slide 34: Subjects with ADWT <20h Reported More Scratching
Subjects with ADWT <20h Reported More Scratching as a Reason for Patch Detachment Versus Subjects with ADWT ≥20h Despite Similar Baseline Characteristics IMPLICATION ─ Lower Tolerability to Peanut Allergen (“More Itchiness”) in Subjects with ADWT <20h1-2 ≥20h ADWT <20h ADWT Baseline characteristics
Slide 35: ADWT Correlates with Clinical Response at Month 12
Average Daily Wear-Time (ADWT) within First 90 Days Correlates with Clinical Response 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 Partici
Slide 36: Lower Rate of Key Safety Outcomes 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 37: DBV's Labeling Strategy: Tool for Shared Decision-Making
DBV’s Labeling Strategy: A Practical Tool to Guide Shared Decision-Making In EPITOPE, participants could be readily distinguished based on ADWT ➢ Those with LOW day-to-day variability (≥20 hours ADWT) ➢ Those with HIGH day-to-day variability (<20 hours ADWT) Subjects with LOW day-to-day variability
Slide 38: 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 39: Alignment on COMFORT Toddlers Supplemental Safety Study
Alignment on COMFORT Toddlers Supplemental Safety Study Intends to Generate Supplemental Safety & Adhesion Data in Peanut Allergic Toddlers, Ages 1-3 YO ▪ 6-month study with an optional 18-month open-label extension ▪ Key study inclusion criteria include skin/serum sensitization to peanut and reacti
Slide 40: US Regulatory Pathway for Toddlers, Ages 1-3 YO
US Regulatory Pathway for Toddlers, Ages 1-3 YO Clear & Well-Defined Regulatory Pathway for the VIASKIN® Peanut Patch Program in Toddlers Under The Accelerated Approval (AA) Pathway 1 2 Could constitute Commitment to a a BLA Post-Marketing 6-Month DBPC submission for a Confirmatory COMPLETED Efficac
Slide 41: VIASKIN Peanut Program in Children Ages 4-7 Years Old
VIASKIN Peanut Program in Children Ages 4-7 Years Old 41
Slide 42: 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
Slide 43: 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
Slide 44: VIASKIN Peanut Patch for Children Ages 4-7: BLA Filing Anticipated 2H 2026
VIASKIN® Peanut Patch for Children Ages 4-7 Years Old BLA Filing Anticipated in 2H 20262 DBV Technologies | Corporate Overview 44 1. DBV Technologies Press Release. October 22, 2024; 2. DBV Technologies Press Release. December 11, 2024.
Slide 45: Long-Term Vision for 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 46: 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 47: 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 48: Anticipated Near-Term Milestones
Anticipated Near-Term Milestones Upcoming Milestones & Catalysts Anticipated Over Next 12 Months TODDLERS (1-3 years) Initiation of COMFORT Toddlers safety trial anticipated in Q2 2025 End-of-Study results from the Open-label Extension to EPITOPE CHILDREN (4-7 years) Initiation of COMFORT Children a
Slide 49: APPENDIX I: VIASKIN Peanut Program in Toddlers
APPENDIX I: VIASKIN Peanut Program in Toddlers (1–3-Year-Olds)
Slide 50: Accelerated Approval Pathway
Accelerated Approval Pathway A Creative & Reasonable Solution Making use of Existing Regulations to Accelerate Availability of VIASKIN® Peanut Patch to Patients ▪ VIASKIN® Peanut patch has breakthrough designation ▪ Demonstrated efficacy with EPITOPE “clinical patch” is predictive of efficacy with t
Slide 51: Minor Alterations to EPITOPE Patch Toward 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 51
Slide 52: APPENDIX II: Legacy Phase 3 Studies in Children Ages 4-11
APPENDIX II: Legacy Phase 3 Studies in Children Ages 4-11 Years Old
Slide 53: 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 54: Phase 3 PEPITES/PEOPLE 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 55: 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 56: Post-Hoc Analysis of PEPITES: Greater Gains in Younger 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 57: Pooled Safety Data from Phase 3 Studies
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 58: REALISE: Long-term Safety Study Design and Results
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 59: Investor Relations 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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