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TOPLINE RESULTSEPITOPE (EPIT in TOddlers with PEanut Allergy)Epicutaneous immunotherapy and Viaskin are under clinical investigation and have not beenapproved for marketing by any health or regulatory authority.1
SAFE HARBOR STATEMENTThis presentation contains confidential and forward looking statements including, but not limited to, statements concerning theoutcome or success of DBV’s clinical trials; its ability to successfully gain regulatory approvals and commercialize products; its abilityto successfully advance its pipeline of product candidates; the rate and degree of market acceptance of its products; and its ability todevelop sales and marketing capabilities. Forward looking statements are subject to a number of risks, uncertainties andassumptions. 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 extentto which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forwardlooking statements it may make. In light of these risks, uncertainties and assumptions, the forward looking events and circumstancesdiscussed in this presentation may not occur and actual results could differ materially and adversely from those anticipated orimplied 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 thatthe future results, levels of activity, performance or events and circumstances reflected in the forward looking statements will beachieved or occur. Moreover, except as required by law, neither DBV nor any other person assumes responsibility for the accuracyand completeness of the forward looking statements. Forward looking statements in this presentation represent DBV’s views only asof the date of this presentation. DBV undertakes no obligation to update or review any forward looking statement, whether as aresult of new information, future developments or otherwise, except as required by law.2
TOPLINE RESULTSEPITOPE (EPIT in TOddlers with PEanut Allergy)Epicutaneous immunotherapy and Viaskin are under clinical investigation and have not beenapproved for marketing by any health or regulatory authority.3
STUDY DESIGNPart B*Viaskin Peanut250 µgPivotal Global Phase 3 TrialRandomized, double-blind, placebo-controlled 362 patients aged 1-3 years Randomized 2:1 50 sites in US, Canada, Europe, AustraliaPlaceboM0DBPCFCPrimary endpoint: difference between the percentage oftreatment responders in the active compared to the placebogroup after 12 months Treatment responder (assessed by DBPCFC) defined as:– If ED 10 mg at baseline, responder if ED 300 mg at M12– If ED 10 mg at baseline, responder if ED 1,000 mg at M12M12DBPCFCBaseline1 mg3 mg10 mg30 mg100 mg300 mgMonth 121 mg3 mg10 mg30 mg100 mg300 mg1,000 mgCRD cumulative reactive dose; DBPCFC double-blind, placebo-controlled food challenge; ED eliciting dose; M month.*EPITOPE Part A was designed to assess the safety of Viaskin Peanut 100 µg and 250 µg to determine the highest safe dose. Based on results of Part A, Viaskin Peanut 250 µg was selected for Part B.Epicutaneous immunotherapy and Viaskin are under clinical investigation and have not been approved for marketing by any health or regulatory authority.2,000 mg4
BASELINE CHARACTERISTICSVP250(N 244)Placebo(N 118)Total(N 362)1 year old83 (34.0%)43 (36.4%)126 (34.8%)2 years old76 (31.1%)38 (32.2%)114 (31.5%)3 years old85 (34.8%)37 (31.4%)122 (33.7%)100.0(30.00 ; 300.0)100.0(30.00 ; 300.0)100.0(30.00 ; 300.0)AgeEliciting DoseMedian (Q1, Q3)Q quartile; VP250 Viaskin Peanut 250 µg.Epicutaneous immunotherapy and Viaskin are under clinical investigation and have not been approved for marketing by any health or regulatory authority.5
PRIMARY ENDPOINT80%P 0.001Percent of Responders (%)70%60%67.0%Δ 33.4%(95% CI: 22.4, 44.5)50%40%30%95% CI lower bound of 22.4% 15% Primary endpoint is met, the study is positive33.5%20%10%0%VP250(N 244)Placebo(N 118)CI confidence interval; ED eliciting dose; ITT intent to treat population; M month; VP250 Viaskin Peanut 250 µg.Treatment responder defined as: for patients with M0 ED 10 mg, responder if ED 300 mg at M12; for patients with a M0 ED 10 mg, responder if ED 1,000 mg at M12.Epicutaneous immunotherapy and Viaskin are under clinical investigation and have not been approved for marketing by any health or regulatory authority.6
ELICITING DOSE 1,000 mg AT MONTH 1280%P 0.001Percent of Responders (%)70%60%64.2%Δ 34.7%(95% CI: 23.6, 45.7)50%40%30%29.6%20%10%0%VP250(N 244)Placebo(N 118)CI confidence interval; ED eliciting dose; ITT intent to treat population; VP250 Viaskin Peanut 250 µg.Treatment responder defined as ED 1,000 mg at M12, regardless of baseline ED.Epicutaneous immunotherapy and Viaskin are under clinical investigation and have not been approved for marketing by any health or regulatory authority.7
SAFETY SUMMARYSerious Adverse Events (VP250 vs placebo): 8.6% vs 2.5%Serious Adverse Events related to IMP (VP250 vs placebo): 0.4% vs 0%– Mild periorbital edemaAdverse Events leading to study discontinuation (VP250 vs placebo): 3.3% vs 0%Anaphylactic reaction related to IMP (VP250 vs placebo): 1.6% vs 0%– No severe events (3 moderate and 1 mild)Any Adverse Event leading to epinephrine intake considered related to IMP (VP250 vsplacebo): 1.2% vs 0%Local application site reactions were the most commonly reported Adverse EventIMP investigational medicinal product; TEAE treatment-emergent adverse event; VP250 Viaskin Peanut 250 µg.Epicutaneous immunotherapy and Viaskin are under clinical investigation and have not been approved for marketing by any health or regulatory authority.8
SUMMARYViaskin Peanut 250 µg resulted in a robust treatment effect in 1-3-year-oldswith peanut allergy– 67% response rate vs. 33.5% for placebo (p 0.001); 95% CI lower bound 22.4%– 33.5% placebo response rate is consistent with an approximately 22% naturalresolution rate for this age range1 and the expected placebo responseSafety is consistent with previous studies– Low discontinuation rate due to Adverse Events– Local application site reactions were the most commonly reported Adverse Event– Total of 4 (1.6%) anaphylactic events related to active treatment, none were severeTEAE treatment emergent adverse event; CI confidence interval.1. Peters RL, et al. J Allergy Clin Immunol. 2015 May;135(5):1257-66.e1-2.Epicutaneous immunotherapy and Viaskin are under clinical investigation and have not been approved for marketing by any health or regulatory authority.9
TOPLINE RESULTSEPITOPE (EPIT in TOddlers with PEanut Allergy)Epicutaneous immunotherapy and Viaskin are under clinical investigation and have not beenapproved for marketing by any health or regulatory authority.10
Randomized, double-blind, placebo-controlled. CRD cumulative reactive dose; DBPCFC double-blind, placebo-controlled food challenge; ED eliciting dose; M month. *EPITOPE Part A was designed to assess the safety of Viaskin Peanut 100 µg and 250 µg to determine the highest safe dose. Based on results of Part A, Viaskin Peanut 250 µg was .
