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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 January 2019 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 re

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The Epicutaneous Immunotherapy Company
January 2019 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 Limited innovation in the field of food allergies has left millions of patients 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 the Viaskin patch No active passage of antigen into the bloodstream Proprietary manufacturing equipment designed,
engineered and developed by DBV Pioneering a New Class of Immunotherapy
Building a Promising Pipeline of
Viaskin 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
EPIT: Unlocking the Immune Properties
of the Skin with the Viaskin Patch Image: Genoskin Dioszeghy V, et al. J Immunol. 2011;186:5629-5637. EPIT targets the immune system on intact skin Condensation chamber formed by Viaskin patch allows natural epidermal water loss to solubilize
dry antigens Langerhans cells capture solubilized antigen in the epidermis Keratinocytes help distinguish pathogens from harmless agents, influencing Langerhans cells to generate an appropriate immune response Langerhans cells can process antigens
and migrate to regional lymph nodes Transmission of immunogenic information, with no allergen passage to the bloodstream
Merging Science & Technology for
Differentiated Drug Development Applied Epicutaneously Electrospray: patented patch manufacturing technology 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
Where We Are Today: Preparing to
Resubmit BLA for Viaskin Peanut Leadership team expanded and strengthened in January 2019 Key medical, manufacturing and regulatory changes implemented ahead of anticipated BLA resubmission for Viaskin Peanut Dr. Hugh Sampson to oversee scientific
and medical strategy globally as CSO and interim CMO Julie O'Neill to direct all manufacturing operations and oversee resubmission of BLA Launch preparation ongoing with experienced commercial team in place Accomplished pharma marketer Kevin
Trapp joined as Chief Commercial Officer in August 2018 North American headquarters established in Summit, New Jersey Search for a US-based Chief Medical Officer ongoing Company to carefully allocate resources throughout BLA resubmission process
Over 150 million cash/cash equivalents and no debt (as of September 30, 2018)
Recent Leadership Expansion:
Transitioning from Late-Stage Research to Potential Commercial-Stage Julie O'Neill Global Manufacturing Dr. Hugh Sampson CSO & Interim CMO Alan Kerr Head of Regulatory Affairs Appointed CSO in 2015 and interim CMO in 1Q 2019 Leading expert
in food allergies and immunology with 35+ years of experience Engaged in 1Q 2019 to direct all manufacturing operations Over 30 years of experience, including multiple FDA approvals Joined June 2016 1Q 2019 update: will report to Daniel Tass ,
CEO 30 years of experience, including several drug approvals/launches Joined in 4Q 2018 30-year track record of building, growing and leading global pharmaceutical businesses Deep development, regulatory and commercial experience Daniel
Tass Chief Executive Officer
Food Allergies: A Major Global 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 Food allergies 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 egg4 50% of peanut-allergic patients
experience accidental allergen ingestion over a median span of 5.6 years6 ~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. Spergel JM et al. Best Prac Res Clin Gastroenterol. 2015;29:771-781. 5. CDC and Prevention, AAP. 6. Neuman D et al. Ann Allergy Asthma Immunol. 2012; 108:326-331
Peanut Allergy: A Daily Burden for
Patients and Families Worldwide 10 Avoidance is difficult: 39% of peanut allergy patients experience an accidental exposure within ~1 year of diagnosis1 Many factors contribute to severity, making reactions unpredictable2 ? 1. Green T, et al.
Pediatrics. 2006;120:1304-1310.. 2. Turner PJ, et al. Allergy. 2016;71:1241-1255. 3. Gupta R, et al. Pediatrics. 2011;128:e9-e17. 4. National survey sponsored by DBV Technologies in 2017 with 500 parents, 300 HCPs and 200 educators 73% of caregivers
are most concerned with accidental exposure to peanuts in their kids' daily life4 67% of caregivers believe it is more difficult to be a parent of a child with a peanut allergy than without4 60% of caregivers say their stress level has
increased because of their child's peanut allergy4 Caregivers are constantly trying to both prevent and prepare for exposure Prevention involves watching and controlling the child's environment at all times Caregivers are always vigilant
and ready to intervene In children with peanut allergy, more than half of reactions are severe3
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 kernel 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 for Viaskin Peanut 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 M12
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 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)
Viaskin Peanut 250 g Clinical
Profile Patients treated with Viaskin Peanut 250 g were only exposed to ~1 peanut via the skin after 3 years1,2 Favorable safety and tolerability observed to date No cases of severe anaphylaxis due to treatment reported Drop-out rate due to
AEs < 2% after 12 months (Phase I, Phase II and Phase III trials) Over 95% compliance observed for up to three years of treatment Most commonly reported AEs are mild to moderate application site reactions Consistent treatment benefit observed in
multiple clinical trials Statistically significant higher rate of responders compared to placebo after 12 months of treatment in Phase II and Phase III trials Significant increase in threshold reactivity (CRD) to peanut protein observed after the
first year of treatment Consistent biomarker trends in peanut-specific IgE and IgG4 across Phase II and Phase III studies Viaskin Peanut 250 g has shown progressive and long-lasting desensitization after 12, 241,2 and 361,2 months of treatment
Fleischer et al. AAAAI 2019, #L32. 2. Sampson et al. JAMA. 2017;318(18):1798-1809. doi:10.1001/jama.2017.16591; Shreffler et al. AAAAI 2017, #L7
SPT: Skin Prick Test, ** ED:
Eliciting Dose ,*** CRD: Cumulative Reactive Dose at Food Challenge 1. The primary analysis evaluating the difference between Viaskin Peanut 250 g and placebo is defined by reaching a lower bound of the two-sided 95% confidence interval (CI)
of 15% 2. An interim analysis will be conducted by the DSMB after the first 50 patients have received 6 months of active treatment to assess the relative change in IgG4 levels in patients treated with Viaskin Peanut 250 g compared to
placebo (n=25). Denotes a completed food challenge; Denotes a pending food challenge Expanding to Toddlers: Part B of Phase III Study of VP in Ages 1-3 Initiated in October 2018 M12 M3 Part A: 51 patients randomized Placebo (n = ~10) 100 g (n
= ~20) 250 g (n = ~20) Highest safe dose (250 g) n = ~233 Placebo n = ~117 100 g dose n=~20 Part B: ~350 additional patients 100 g dose Positive DSMB from Part A: No safety concerns identified Efficacy Endpoints Study
Population Children ages 1-3 with peanut allergy > 0.7 kUI/ L peanut-specific IgE and 6 mm SPT* wheal Reactive dose at M0 300 mg peanut protein Primary endpoint at M121 Treatment responders (%) in active group compared to placebo
at 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 Main secondary endpoints: CRD***, changes in peanut sIgE and sIgG4 M0 M0 Selected
dose = 250 g dose M6 DSMB2
Viaskin Milk: Milk Allergy (CMPA)
Phase II Study Identified Safe/Effective Dose for Children Pediatric Phase I/II USA & Canada Part A: 18 patients Part B: 180 patients M0 Phase I (Part A) Cohort at 150 g dose Cohort at 300 g dose Cohort at 500 g dose DSMB DSMB FDA
& DSMB Placebo 300 g 150 g 500 g Phase II (Part B) M12 M24 M36 Efficacy Endpoints Study Population Children (2-11) and adolescents (12-17) Highly sensitive to milk ( 10 kU/L milk-specific IgE and 6 mm SPT* wheal)
Reactive dose at baseline (M0) 300 mg cow's milk protein (CMP) (~ 9.4 mL of cow's milk) Treatment responder definition at M12: 10-fold increase in CRD** and at least 144 mg of CMP OR CRD 1,444 mg Key
secondary endpoints: Change from baseline in IgE, IgG4 * SPT: Skin Prick Test ** CRD: Cumulative Reactive Dose at Food Challenge ***Protocol change implemented in August 2018 to switch all patients to 300 g (from 500 g) for treatment up
to 24 months Denotes a completed food challenge; Denotes a pending, optional food challenge Open Label Food challenges optional following 12 and 24 months of receiving 300 g 300 g***
MILES Results: Support Viaskin Milk
300 g as the Potential First Treatment for CMPA in Children 2-11 Response Rate (ITT*) Favorable safety, tolerability and compliance Overall discontinuation rate of 4.5% 1.5% dropout due to AEs Most AEs related to application site (mild to
moderate) No severe anaphylaxis No SAEs or epinephrine related to treatment Treatment adherence was high Mean patient compliance > 95% % of Responders (90% CI) p = 0.733 p = 0.042 p > 0.999 n = 40 n = 38 n = 38 n = 36 * Missing data: failure
imputation (considered as non-responders) in ITT population P-values obtained using exact logistic regression ITT, Intent-to-Treat
DBV Technologies: Pioneering a New
Class of Immunotherapy CEO Daniel Tass joined DBV in November 2018 Key medical, manufacturing and regulatory leadership changes announced ahead of anticipated resubmission of BLA for Viaskin Peanut Phase III clinical program for Viaskin Peanut
in children ages 4-11 completed (PEPITES & REALISE trials) in 2018 Positive preliminary Phase I/II data in second food allergy candidate, Viaskin Milk Key commercial roles, including Kevin Trapp, Chief Commercial Officer, recruited and onboarded
in Summit, New Jersey office Continuing to build a talented team with global headquarters in US and France 3Q 2018 cash position of 153.9mn
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
Last updated: Jan 7, 2019