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Safe Harbor 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 approval

Key Takeaway: The Epicutaneous Immunotherapy Company December 2018 Genoskin Exhibit 99.1 Safe Harbor 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 r

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The Epicutaneous Immunotherapy Company
December 2018 Genoskin Exhibit 99.1
Safe Harbor 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 pipeline of product candidates; the rate and degree of market acceptance of its products; and its ability to develop sales and marketing capabilities. Forward looking statements are subject to a number of risks, uncertainties and
assumptions. Moreover, DBV operates in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for DBV's management to predict all risks, nor can DBV assess the impact of all factors on its
business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward looking statements it may make. In light of these risks, uncertainties and assumptions, the
forward looking events and circumstances discussed in this presentation may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. You should not rely upon forward
looking statements as predictions of future events. Although DBV believes that the expectations reflected in the forward looking statements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and
circumstances reflected in the forward looking statements will be achieved or occur. Moreover, except as required by law, neither DBV nor any other person assumes responsibility for the accuracy and completeness of the forward looking statements.
Forward looking statements in this presentation represent DBV's views only as of the date of this presentation. DBV undertakes no obligation to update or review any forward looking statement, whether as a result of new information, future
developments or otherwise, except as required by law.
Advancing novel skin immunotherapies
for patients with food allergies and other immunological diseases Over the last two decades, limited innovation in the food allergy field has left millions of patients significantly underserved today We are focused on discovering, developing and
commercializing our novel skin immunotherapy product candidates using our proprietary Viaskin Technology Platform Potent activation of the immune system with Epicutaneous patch No active passage of antigen into blood stream Proprietary manufacturing
equipment designed, engineered and developed by DBV Pioneering a New Class of Immunotherapy Product Candidates
Promising Pipeline of Product
Candidates DEVELOPMENT STAGE PROGRAM INDICATION DISCOVERY PRE-CLINICAL PHASE I PHASE II PHASE III Viaskin Peanut Peanut Allergy Viaskin Milk Cow's Milk Protein Allergy Viaskin Egg Hen's Egg Allergy Mechanistic Study Eosinophilic
Esophagitis 5 Programs Undisclosed Diagnostics with Nestl Health Science Cow's Milk Protein Allergy Ages 4-11 (Breakthrough Therapy and Fast Track Designation*) Ages 1-3 Ages 2-17 (Fast Track Designation**) Ages 4-17 Adolescents &
Adults Infants * US FDA Breakthrough Therapy and Fast Track designation in children ** US FDA Fast Track designation in pediatric patients two and older
Recent Viaskin Peanut Updates: BLA
Submitted to FDA in October 2018 Fast track for Viaskin Peanut Breakthrough for Viaskin Peanut PEPITES Phase III data REALISE Phase III data Breakthrough and fast track designations potentially allow for expedited review. Based on recent
communications with FDA, determination regarding expedited review may depend on allergenic extract considerations and non-PDUFA status. MAA submission Pre-BLA meeting BLA submitted in October 2018 2017 2019 2016 2015 2011 2018 1H 2H FDA agreement
that the available efficacy and safety data for Viaskin Peanut support submission of BLA for treatment of peanut allergic children ages 4-11
Recent Viaskin Peanut Updates: BLA
Submitted to FDA in October 2018 Scaled-up GMP manufacturing process in place Plans in place for additional machine post-launch Annual production capacity of 30 million Viaskin Peanut patches per GEN4.0 machine Fully Integrated Manufacturing Process
API dry powder: highly purified allergen extract Viaskin Electrospray Technology Commercial-Scale GEN4.0 Viaskin Patch API Electrospray/GEN4.0 Viaskin Peanut patch
Viaskin Technology: Building a
Transformative Immunotherapy Platform Pioneering a new class of immunotherapy Merging science and technology for differentiated drug development Advancing transformative treatments for large, underserved patient populations Food allergies and
related allergic diseases Immune system disorders Autoimmune diseases Vaccination Creator of Epicutaneous Immunotherapy (EPIT) Biologic compound provides allergenic information to activate the immune system through the skin Viaskin: novel and
proprietary technology 15 years of R&D resulting in 17 patent families and significant trade secrets Viaskin platform targets antigen-presenting cells of the skin
Di Meglio P, et al. Immunity.
2011;35:857-869. Nestle FO, et al. Nat Rev Immunol. 2009;9:679-691. Senti G, et al. Allergy. 2011;66:798-809. Metz M, et al. Curr Opin Immunol. 2009;21:687-693. Langerhans cell Keratinocyte Epidermis The Skin Has Important Immune Properties Immune
functions of the skin include Responding to trauma, toxins, and infectious agents Maintaining self-tolerance, preventing allergy, and inhibiting autoimmunity Keratinocytes Distinguish pathogens from harmless agents Influence nearby Langerhans cells
to generate an appropriate immune response Langerhans cells Antigen-presenting cells that can process antigens and migrate to regional lymph nodes
Transmission of immunogenic
information, with no allergen passage to the bloodstream Solubilized antigen is captured by Langerhans cells in the epidermis Targeting the immune system on intact skin EPIT: Pioneering a New Class of Immunotherapy Image: Genoskin Dioszeghy V,
et al. J Immunol. 2011;186:5629-5637.
Merging Science & Technology for
Differentiated Drug Development Applied Epicutaneously Electrospray: patented manufacturing tool that allows for precise antigen deposits without adjuvants Patented electrostatic patch with condensation chamber allows the antigen to penetrate upper
layer of epidermis EPIT Activates the Immune System Through Intact Skin Dioszeghy V, et al. J Immunol. 2011;186:5629-5637. Mondoulet L, et al. Immunotherapy. 2015;7:1293-1305. Novel Viaskin Technology Platform
Modular components technology
versatility Highly scalable Broadly applicable platform Manufacturing capabilities In-house development and engineering of electrospray machines Development and engineering expertise at DBV [ES GEN4.0 machine] Proprietary & Patented
Manufacturing Capabilities Developed by DBV
Dose flexibility Biological API
deposit between 20 and 500 g/cm2 API stability Solid & soluble protein layer, no glue Homogeneous repartition of API Uniform delivery into skin Replicability High dosage control in each patch Bioavailability High solubility from
electrostatic forces instead of glue Electrical ground High voltage (up to 20,000 V) Regulated flow of dissolved antigen Fine spray of electrically charged droplets Dry layer of antigen Capillary nozzle Core Innovation: Differentiated Electrospray
Boost Vaccination Peanut Eczema
Eosinophilic Esophagitis Hemophilia A Allergic March Electrospray Viaskin II Viaskin I CORE TECHNOLOGY EPIT Food allergies EPIT Allergy related diseases Epicutaneous vaccination Immuno Rebalancing Tolerance induction Epicutaneous Desensitization
Epicutaneous Vaccination Broad geographic applications USA, Europe, Australia, Canada Long patent protection Initial core patents through 2022 Other key patents through 2030-35 Innovation-driven patent lifecycle management Robust IP Portfolio: Core
Technology, Broad MoAs & Specific Indications
Food Allergies: Addressing an Urgent
Unmet Medical Need Every 7 minutes a child goes to the emergency room for an allergic reaction to food2 Each year, approximately 150 deaths are due to allergic reactions; most deaths occur in patients who are aware of their allergy3 50% of
peanut-allergic patients experience accidental allergen ingestion over a median span of 5.6 years4 Peanut allergy can cause severe, potentially fatal, allergic reactions, including anaphylaxis Eosinophilic esophagitis (EoE),a progressive
inflammatory disease, is often caused by ingesting foods, such as peanut, milk and egg6 ~8% of children in the U.S. In the U.S., approximately 1 million children ages 1-11 have a diagnosed peanut allergy1,5 or ~2 children in every classroom, have a
food allergy1 Peanut allergy is one of the most common food allergies in children 1.Gupta RS et al. Pediatrics. 2011;128(1):e9-e17. 2. Clark S et al. J Allergy Clin Immunology 2011; doi:10.1016/j.jaci.2010.10.040. 3. Kumar A et al. Clin Dev Immunol.
2005;12(4):281-287. 4. Neuman D et al. Ann Allergy Asthma Immunol. 2012; 108:326-331. 5. CDC and Prevention, AAP. 6. Spergel JM et al. Best Prac Res Clin Gastroenterol. 2015;29:771-781.
In Last Several Decades, No
Significant Innovation in Food Allergy Immunotherapy Safety is paramount: ingesting small quantities of offending allergen can cause life-threatening reactions After several decades, these patients are still underserved: there are no approved
treatments today Current disease management is allergen avoidance: time-consuming, restrictive, major cause of worry and stress There is NO margin for error when exposing patients to a potentially life-threatening allergen
Our Solution for a Hard-to-Treat
Disease Contamination leading to peanut consumption is a serious threat1 Estimated detectable peanut residue ranges from 0.025-45mg of peanut protein2 Desensitization therapies could offer significant reduction of the risks associated with
accidental exposures 1,3,4,5 Yet, even amounts of less than 1 peanut can cause severe reactions Viaskin Peanut utilizes the skin's immune properties, which amplifies minimal allergen exposure Balancing risk-benefit drug profiles for these
patients has been a difficult task for the field 1.Baumert JL, et al. J Allergy Clin Immunol Pract. 2017. doi:10.1016/j.jaip.2017.05.006. 2. Hefle S, et al. J Allergy Clin Immunol 2007; 04.013. 3. Shreffler W, et al. Ann Allergy Asthma Immunol 2017;
1081-1206. 4. Remington, B, et al. Ann Allergy Asthma Immunol. doi: http://dx.doi.org/10.1016/j.anai.2017.08.224. 5. Remington, B et al. ACAAI 2018 #A302
PEPITES Pivotal Phase III Trial
Results Reported in 4Q17 Efficacy Endpoints Study Population Highly allergic patients ages 4-11 > 0.7 kU/ L peanut-specific IgE and 6mm or 8 mm SPT* wheal Reactive dose at M0 300 mg peanut protein (i.e. approx 1 peanut) Treatment
responder definition Assessed using DBPCFC** For patients with a M0 ED*** 10mg: responder if ED 300 mg at M12 For patients with a M0 ED > 10mg: responder if ED 1,000 mg at M12 Key secondary endpoints CRD****, changes in
peanut sIgE and sIgG4 *SPT: Skin Prick Test ( 6mm for children 4 to 5 years 8 mm children 6 years **DBPCFC: Double-Blind Placebo-Controlled Food Challenge *** ED: Eliciting Dose **** CRD: Cumulative Reactive Dose at Food
Challenge Denotes a completed food challenge; Denotes a pending food challenge 356 peanut allergic children 31 centers in US, Canada, Australia, Germany, Ireland 250 g 250 g M0 M12 M36 PEPITES Open Label Follow Up Placebo 250 g M36
PEPITES Baseline Characteristics:
Highly Allergic Patient Population 356 Patients Randomized Active: 238 Placebo: 118 Peanut Eliciting Dose (mg) Median: 100 Mean: ~140 Medical History of Patients n % Asthma 169 47.5 Eczema/Atopic Dermatitis 218 61.2 Allergic Rhinitis 199 55.9
Polyallergic 305 85.7
PEPITES Results: Primary Efficacy
Endpoint Shows Significant Treatment Benefit with Favorable Safety Favorable tolerability & safety profile reported Most AEs were mild to moderate application site reactions No cases of severe anaphylaxis No SAE imbalance (4.2% in Viaskin Peanut
vs 5.1% in placebo) 1.1% discontinuation rate due to treatment-emergent AEs >95% compliance during the trial No observed treatment-related AEs due to physical activity or concomitant illness = 21.7% p = 0.00001 n = 118 n = 238 Response
Rate (ITT) % of Responders Response rate was statistically significant, but 15% lower bound of the 95% CI proposed in the SAP submitted to FDA was not reached LCL 12.4 UCL 29.8
PEPITES Results: Significant
Increase in Threshold Reactivity to Peanut Protein Observed mBOCF = Modified Baseline Observation Carried Forward 1Davis, C et al, ACAAI 2018 #A303 Unique MoA increases protection to peanut without requiring major exposure to offending allergen No
consumption of peanut during treatment Viaskin Peanut 250 g dose = ~1/1,000 mg of a peanut kernel Threshold reactivity measured during exit food challenge showed a significant difference between active and placebo Patients treated with Viaskin
Peanut were 4.3 times more likely to improve their peanut threshold reactivity level versus placebo (OR = 4.3 (95% CI 2.7- 7.0), p<0.001)1 Significant immunomodulation confirmed increase in peanut consumption over time Mean (95% CI)
PEPITES Results: Robust
Immunological Changes Support Treatment Effect p < 0.0001 p < 0.0001 p < 0.0001 n 238 232 229 224 n 117 116 112 109 n 238 231 229 224 n 117 116 111 110 p < 0.0001 p < 0.0001 p = 0.0421
ANCOVA=analysis of covariance; CI=confidence interval; ED=eliciting dose; PS-IgE=peanut-specific immunoglobulin E; PS-IgG4=peanut-specific immunoglobulin G4. *Model independent (using observed data). Based on T-test associated with the
randomized group beta coefficient from a fixed-effects, repeated-measures ANCOVA model for change from baseline with randomized group, timepoint, treatment-by-timepoint interaction, and screening ED subgroup as categorical covariates (using
log-transformed PS-IgE and PS-IgG4 observed data). PS-IgE Changes Overtime PS-IgG4 Changes Overtime
JAMA Publication 2017: Long-term
Extension Data Shows Benefit Increases Over Time in Phase IIb Study Results shown for Viaskin Peanut 250 g * 1 child discontinued (not related to Viaskin Peanut) ** 2 children discontinued (none related to Viaskin Peanut) Sampson et al.
JAMA. 2017;318(18):1798-1809. doi:10.1001/jama.2017.16591,. Shreffler et al. AAAAI 2017, #L7 Response Rate at OLFUS: Baseline, Year-1 and Year-2 Cumulative Reactive Dose in OLFUS Excluding missing data n = 21 n = 21 n = 20 n = 18 0 mg 1,000 mg
2,000 mg 3,000 mg 5,000 mg Median = 1,440 mg Median = 1,440 mg Median = 444 mg Median = 44 mg Mean 95% CI Observed values, ITT n = 21 n = 20* n = 18** 57.1% (12/21) 80.0% (16/20) 83.3% (15/18) 2,453.9 mg 1,883.5 mg 1,067.8 mg 84.5 mg
PEPITES Post-Hoc Analysis Using
VIPES Responder Definition Suggests Consistent Treatment Effect Observed from Phase II to Phase III = 28.8% p < 0.0001 = 21.7% p < 0.00001 % of Responders % of Responders n = 238 n = 118 Actual Reported Response Rate in PEPITES
(%) PEPITES Response Rate Using the VIPES Response Criteria n = 238 n = 118 LCL 12.4 UCL 29.8 LCL 18.9 UCL 37.4
Positive Phase III REALISE Results
Support Regulatory Filings for Viaskin Peanut * SPT: Skin Prick Test Patients 4 to 11 with history of IgE-mediated reactions to peanut Including patients with severe anaphylaxis 14 kU/L peanut-specific IgE and 8 mm SPT* wheal Safety
& Exploratory Endpoints Primary endpoint to assess safety at M6 Treatment Emergent Adverse Events No oral food challenges are required at baseline Exploratory endpoints Quality of Life Questionnaires (FAQLQ & FAIM) Evolution of
peanut-specific serological markers over time (IgE, IgG4, SPT wheal) Study Population Placebo 393 peanut allergic children 32 centers in North America 250 g 250 g Safety Checkpoint Safety Checkpoint Safety Checkpoint M36 M24 M12 M0 M6
Open Label Safety Endpoint Positive 6-month safety results confirmed the safety and tolerability profile observed in PEPITES, VIPES and CoFAR6
Viaskin Peanut's Profile
Aligned with Patients and HCPs Treatment Objectives 1.DBV Internal Market Research; survey of allergists (100) in 1Q 2017 and 4Q 2017; survey of physicians (500), caregivers/children (360): 2016-2017, 1Q 2015 survey of 240 caregivers of peanut
Last updated: Nov 29, 2018