Slide 1: DBV Technologies Corporate Presentation January 2023
DBV TECHNOLOGIES Corporate Presentation I January 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 Late-stage Clinical Programs Comprehensive late-stage clinical programs in food allergy indications Novel Viaskin™ Technology Novel Viaskin™ technology based on Epicutaneous Immunotherapy (EPIT™) Science-Driven Leadership Team Science-driven leadership team with deep regulatory
Slide 4: Committed to Generating Long-term Viaskin Data to Inform Real-Life Use
Committed to Generating Long-term Viaskin™ Data to Inform Real-Life Use Completed and Currently Ongoing Clinical Trials* Program and Indication Trial Phase 2 Phase 3 PEPITES: Ages 4-11 years PEOPLE: Ages 4-11 years REALISE: Ages 4-11 years Viaskin Peanut (DBV712) - Peanut Allergy VITESSE: Ages 4-7 y
Slide 5: In the US, 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 6: 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 7: Allergists, Families and Children Want Additional Protection from Accidental Peanut Exposure
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 8: Families and Allergists Want Additional Therapy Options for Peanut Allergy
Families and Allergists Want Additional Therapy Options for Peanut Allergy1,2 Oral immunotherapy is often not an ideal option for many patients and their families1 Complex dose escalation schedule, requiring multiple visits to an allergist’s office that can each last more than 1 hour Avoidance of ce
Slide 9: Target Product Profile: A Treatment That Can Be Incorporated into Busy Lives
Target Product Profile: A Treatment 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, stress or menstrual cycles No restriction on activities such a
Slide 10: The Viaskin Patch: Our Innovative Approach to Epicutaneous Immunotherapy
The Viaskin™ Patch: Our Innovative Approach to Epicutaneous Immunotherapy 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, al
Slide 11: EPIT Aims To Re-educate the Immune System by Inducing Specific Regulatory T Cells
Epicutaneous Immunotherapy (EPIT™) Aims To Re-educate the Immune System by Inducing Specific Regulatory T Cells1-6 EPIT delivers allergen to Antigen Presenting Cells capture allergen and Regulatory T Cells act on the immune system to suppress the intact skin induce unique Regulatory T Cells allergic
Slide 12: Viaskin Uses Minimal Amounts of Allergen to Induce an Immune Response
Viaskin™ Uses Minimal Amounts of Allergen to Induce an Immune Response1-3 Solubilized allergen is captured by skin dendritic cells (eg, Langerhans cells) in the epidermis Langerhans cells process the allergen, migrate to the lymph nodes and present its epitopes to the lymphocytes, leading to a speci
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Slide 14: Occurrence of Reactions Is Determined by Eliciting Dose and Exposure Dose
Occurrence of 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 when unmistakable allergic
Slide 15: Modeling Data Suggest Increasing Eliciting Dose Decreases Risk of Allergic Reaction
Decrease in Reaction Risk Following Allergen Immunotherapy Modeling* data suggest increasing a patient’s eliciting dose decreases ED after allergen the 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
Slide 16: Phase 3 PEPITES/PEOPLE: Viaskin Peanut 250 µg in Children 4–11 Years
Phase 3 PEPITES/PEOPLE: Viaskin Peanut 250 µg in Children 4–11 Years Of Age Full results published in peer-reviewed publications JAMA (PEPITES)1, Journal of Allergy & Clinical Immunology (PEOPLE)2 Viaskin Peanut Viaskin Peanut Global Phase 3 Trial 250 µg 250 µg Randomized, double-blind, placebo-cont
Slide 17: 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 40
Slide 18: Changes in ED Maintained or Improved Over 3 Years in the Majority of Subjects
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 19: Post-Hoc Analysis of PEPITES Data Supports Greater Gains in Younger 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 μ
Slide 20: Pooled Safety Data from Phase III Studies of Viaskin Peanut
Pooled Safety Data from Phase III 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) • Seriou
Slide 21: Viaskin Peanut Regulatory Background
Viaskin™ Peanut Regulatory Background FDA issued a Complete Response Letter (CRL) in August 2020 regarding the Biologics License Application for Viaskin Peanut in children ages 4 to 11 years1 FDA identified four concerns in the CRL, including1 – Impact of patch-site adhesion on efficacy – Need f
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Slide 23: VITESSE Partial Clinical Hold Lifted on December 23
VITESSE Partial Clinical Hold Lifted on December 23 On September 7 Importantly, DBV had not screened or DBV initiated its Phase 3 clinical trial, VITESSE, evaluating VIASKIN PEANUT in children recruited any patients into the trial at ages 4-7 years old. the time of the partial clinical hold. On Sept
Slide 24: FDA Stated VITESSE May Proceed with Protocol Revisions
FDA Stated VITESSE May Proceed with Protocol Revisions That Addressed Agency’s Requested Modifications FDA Modification DBV Response Redefinition of Minimum Daily The updated VITESSE IFU now outlines that Viaskin Peanut 250 µg is to be worn for as close to a full day as possible (i.e., 24 Wear Time
Slide 25: VITESSE is Designed for Younger, More Allergen-Sensitive Patients
VITESSE is Designed for Younger, More Allergen-Sensitive Patients Inclusion criteria, primary efficacy endpoint, responder criteria, efficacy assessment methodology and safety endpoints were not impacted by the Partial Clinical Hold letter and remain unchanged from initial VITESSE protocol Viaskin P
Slide 26: Summary
Summary Patch overlay* Modified (circular, larger) Square Age 4-7 years 4-11 years Inclusion Criterion Baseline ED < 100 mg < 300 mg Baseline ED Month 12 ED Baseline ED Month 12 ED Responder Definition < 30 mg ≥300 mg < 10 mg ≥300 mg 100 mg ≥600 mg >10 mg ≥ 1,000 mg Viaskin Peanut 250 µg is
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Slide 28: Phase 3 EPITOPE: Viaskin Peanut 250 µg in Toddlers 1-3 Years
Phase 3 EPITOPE: Viaskin Peanut 250 µg in Toddlers 1-3 Years Of Age Results Presented at American College of Allergy, Asthma and Immunology in November 20221 Viaskin Peanut Pivotal Global Phase 3 Trial 250 µg Randomized, double-blind, placebo-controlled 362 patients Randomized 2:1 Placebo 51 sites i
Slide 29: Viaskin Peanut Demonstrated a Statistically Significant Treatment Effect
Viaskin Peanut Demonstrated a Statistically Significant Treatment Effect1 80% 80% P<0.001 70% P<0.001 70% Percent of Participants with ED 67.0% 60% 64.2% 60% ≥1,000 mg at M12 (%) Percent of Responders (%) 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% 29.6%
Slide 30: Shift Toward Reduction in Reaction Severity Following 12 Months of Treatment
Shift Toward Reduction in Reaction Severity Following 12 Months of Viaskin Peanut Treatment1 Maximum Symptom Severity at Month 12 DBPCFC At baseline Double-Blind, Placebo-Controlled Food 100% Challenge (DBPCFC), the proportions of maximum reaction 23.0% 12.5% 25.5% 28.6% severity were balanced betwe
Slide 31: EPITOPE Safety Summary
EPITOPE Safety Summary1 Safety Profile Consistent with Prior Viaskin Peanut Studies Local Application Site Reactions (VP250 vs placebo): primarily mild to moderate that decreased in frequency with time 99.6% vs 94.1% Serious Adverse Events (VP250 vs placebo) 8.6% vs 2.5% Serious Adverse Events relat
Slide 32: Two Potential Regulatory Pathways for Viaskin Peanut
Two Potential Regulatory Pathways for Viaskin™ Peanut Flexibility of Viaskin manufacturing process supports potential for two in-market patches Target Age Patch* Phase III Efficacy Data Next Steps • FDA guidance on potential regulatory pathway 1-3 years old • VITESSE enrollment • Safety study protoc
Slide 33: Unlock the Powerful Immune Properties of the Skin with our 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 33
Slide 34: Our Long-Term Vision is to Realize the 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) – Milk Allergy Viaskin Milk (DBV135) – Eosinophilic Esophagitis Viaskin – Autoimmune and Inflammatory Disorders Viaskin – Vaccines DBV Technolog
Slide 35: September 30, 2022 YTD Financial Results
September 30, 2022 YTD Financial Results $212.7M in cash and cash equivalents as of September 30, 2022 $14.1M1 raised through ATM in May $181.2M1 raised in PIPE in June $27.1M reimbursement of the French Research Tax Credit2 Cash used in operations Decreased by ~65%3 for nine months ended September
Slide 36: Near-Term Milestones
Near-Term Milestones Initiation of FDA interaction about FY2022 Financial Publication of VITESSE EPITOPE data Results EPITOPE results enrollment DBV Technologies | Corporate Overview 36
Slide 37: Investment Highlights
Investment Highlights Late-stage Clinical Programs Comprehensive late-stage clinical programs in food allergy indications Novel Viaskin™ Technology Novel Viaskin™ technology based on Epicutaneous Immunotherapy (EPIT™) Science-Driven Leadership Team Science-driven leadership team with deep regulatory
Slide 38: Investor Relations Contacts
Investor Relations Anne Pollak +1 857-529-2363 anne.pollak@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-technologies.
Slide 39: 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 40: 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 41: REALISE: Study Design and Preliminary Results of the 6-Month Blinded Portion
REALISE: study Design and Preliminary Results of the 6-Month Blinded Portion1 Children 4–11 years REALISE Phase 3 Randomized, double-blind, placebo- Placebo controlled 250 µg 393 patients aged 4–11 years with history of Safety checkpoint Safety checkpoint Safety checkpoint IgE-mediated reactions to