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Page 1: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

June 2017

The EpicutaneousImmunotherapy

Company

1

Page 2: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

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.

2

Page 3: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

DBV Technologies Today Recent Progress

3

Viaskin Peanut – Phase III data expected in 2H 2017

― Pivotal Phase III recruitment completed ahead of schedule, driven by strong patient demand

― REALISE trial enrollment complete; designed to support BLA filing and collect real-life data

― 24-month follow-up data demonstrates sustained treatment benefit for up to three years; late breaking data presented at AAAAI 2017

Viaskin Milk – Phase IIb data expected in 1H 2018

― Fast Track designation received 3Q’16; Phase IIb completed recruitment in 2H’16

― EoE Phase IIa pilot trial at CHOP completed randomization in 1H’17

Immunology & Vaccines

― Viaskin rPT POC trial results provide insight into potential future vaccine development

― Crohn’s disease, hemophilia and celiac disease prioritized as next targets

US commercial operations

― Completed recruitment of key US commercial roles

New effort in diagnostics

― Nestlé Health Science collaboration initiated for milk allergy diagnostic tool

Page 4: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

Product Candidates: Leveraging our Platform TechnologyViaskin In and Beyond Food Allergies

DEVELOPMENT STAGE

PROGRAM INDICATIONCOMMERCIAL

RIGHTS DISCOVERY PRE-CLINICAL PHASE I PHASE II PHASE III

ViaskinPeanut

Peanut AllergyDBV Worldwide

Viaskin Milk

Cow’s Milk Protein Allergy

DBV Worldwide

Viaskin Egg

Hen’s Egg Allergy

DBV Worldwide

Allergic Diseases

Eosinophilic Esophagitis

DBV Worldwide

VaccinesPertussis

boostDBV Worldwide

4

FDA Breakthrough*

* US FDA Breakthrough Therapy and Fast Track designation in children** US FDA Fast Track designation in pediatric patients two and older

FDA Fast Track**

FDA Fast Track*

Page 5: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

Changing the Field of Immunotherapy Epicutaneous Immunotherapy

Dioszeghy et al, 2011. J. Immunol, 186: 5629-37

EPIT delivers antigen through the skin targeting the APC Langerhans cells

Langerhans cells capture antigen and migrate to lymph node to activate immune system

Antigen does not enter the bloodstream

5

Langerhans cells

Time (hours)

Epidermis Dermis Lymph node

0

1

2

3

4

0 6 24A48

8+ D

C (

% o

f to

tal)

0

1

2

3

4

0 6 24 48 72A48

8+ D

C (

% o

f to

tal)

0

0.1

0.2

0.3

0.4

0 6 24 48 72A48

8+ D

C (

% o

f to

tal)

Time (hours) Time (hours)

Blood Stream

EPITSubcutaneous

injection

Page 6: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

Our Viaskin TechnologyA Novel Potential Immunotherapy

Viaskin provides allergenic

information to immune system without entering the blood stream

Dermis

EpidermisSKIN

Langerhanscells

Protein

Water loss & solubilisation

Condensation chamber

6

Page 7: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

Despite Increasing Awareness and Prevalence No Treatment Available in Food Allergy

7

High unmet medical need Avoidance is not enoughNeed for a safe and

convenient treatment

50% increase in prevalence among children in the US (1997-2011)1

1 in 13 children has a food allergy2

Most prevalent food allergies to peanut and milk3

~150 deaths per year in the US4

Most deaths occur in patients who are aware of their allergy5

Every 3 minutes, an allergic reaction leads a patient to ER6

50% of children experience accidental ingestion of traces within 5 years, 75% within 10 years7

No therapy available

Only option is avoidance

Goal is to increase protection and to reduce the risk of anaphylactic reaction in case of accidental exposure

Other immunotherapy developments have failed due to safety concerns

1Jackson KD et al. National Center for Health Statistics Data Brief. No. 1212 FARE Food Allergy Facts and Statistics3 Gupta RS et al. Pediatrics. 2011;128(1):e9-e17

4 FDA Food Facts March 20175 Kumar A et al. Clin Dev Immunol. 2005;12(4):281-2876 Clark S et al. J Allergy Clin Immunol. 2011;127(3):682-6837 Burks W et al. J Allergy Clin Immunol. 2012;129(4):906-920

Page 8: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

The Viaskin* Technology Patient-Friendly and Self-Administrable

1 Viaskin per day, ready-to-use and patient friendly

Self-applied to intact skin on the arm or back

Non-invasive, safe, well-tolerated

Potential treatment for children and adults

Expected to be prescription product

*Under evaluation in clinical trials for peanut and milk allergies; statements based on trial results observed to date.

Patented and wholly-owned manufacturing process

*

8

Page 9: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

Lead EPIT Product Candidate: Viaskin PeanutComprehensive Drug Development Plan

Phase IPhase IIb

VIPESOLFUS-VIPES

Phase IIIPEPITES

Goal:Registration

Phase IIaARACHILD

Biomarkers and MoAProof of Concept

Core Development Plan

Phase IICoFAR 6

Academic Collaborations

100 patients 221 patients 356 patients

54 patients 75 patients

9

REALISE393 patients

Page 10: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

VIPES: Dose-Finding Phase IIb Efficacy and Safety Trial Evaluation at 12 Months

Highly allergic patients

o > 0.7 kUI/ L peanut-specific IgE and ≥ 8 mm SPT* wheal

o Reactive dose at M0 ≤ 300 mg peanut protein (ie. approx 1 peanut)

VIPES & OLFUS Efficacy

Primary endpoint at M12, M24 and M36

o ≥ 1000 mg reactive dose OR

o ≥ 10-fold of the initial reactive dose

Main secondary endpoints: CRD**, changes in peanut sIgE and sIgG4

Study Population

*SPT: Skin Prick Test**CRD: Cumulative Reactive Dose at Food Challenge

Denotes a completed food challenge

M0 M12 M12 M24 M26

Placebo

50 µg

100 µg

250 µg

VIPES Dose-finding

250 µg221 stratified patients, 22 centers in US, Canada, France, Poland, and Netherlands

OLFUS-VIPESOpen Label Follow-Up Study

10

M0

Page 11: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

221 subjects randomized

113 Children (6-11)

73 Adolescents (12-17) & 35 Adults (18+)

VIPES Patient Population Snapshot at BaselineHighly Allergic Patients

6

11

17

23

38

18

1 2

13 13

39 40

1 3 10 30 100 300

Ran

do

miz

ed S

ub

ject

s (n

)

Peanut Protein Reactive Dose (mg)

Children Adolescents/Adults

Highly allergic subjects (median)

Children = 30 mg

Adolescents & Adults = 100 mg

n %

Asthma 130 58.8

Eczema/Atopic Dermatitis 114 51.6

Allergic Rhinitis 96 43.4

Polyallergic 183 82.8

Medical history of patients

11

Very high IgE levels: > 100 kU/L

47% of Children

38% of All Subjects

Page 12: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

VIPES Highlights Viaskin’s Safety Profile & Ease of Use High Compliance Rate, Low Drop-Outs

n=

Placebo

56

50 µg

53

100 µg

56

250 µg

56

Total

221

Overall compliance (%) Median 97.0 96.9 97.8 98.7 97.6

Drop-out not related to Viaskinn

(%)

2

(3.6)

2

(3.8)

6

(10.7)

2

(3.6)

12

(5.4)

Drop-out related to Viaskinn

(%)

0

(0.0)

0

(0.0)

1

(1.8)

1

(1.8)

2

(0.9)

12

No use of epinephrine related to Viaskin Peanut application

No SAEs related to Viaskin Peanut

2 withdrawals due to related adverse events (i.e. dermatitis)

Most frequent related AEs: local cutaneous reaction >90% of subjects mainly mild and moderate (50% with a duration < 2 months)

Page 13: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

VIPES Primary Endpoint MetFocus on Children (Ages 6-11)

Response rate in children across doses after 12 months

19.4%

57.1%

46.2%53.6%

0%

10%

20%

30%

40%

50%

60%

70%

80%

Placebon = 31

50 µgn = 28

100 µgn = 26

250 µgn = 28

% o

f re

spo

nd

ers

(95%

CI)

p= 0.0076

p= 0.0453p= 0.0035

13

Page 14: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

VIPES Peanut Consumption in Children (Ages 6-11)Clear Dose Response, Clear Magnitude of Effect

14

Increase in CRD in children after 12 months (Mean and Median)*

1,000 mg

500 mg

0 mg

1,500 mg

2,000 mg

1,121.0 mg

Median = 135.0

Median = 0.0

Median = 214.5

Placebon = 30

Median = 400.0

50 μgn = 28

100 μgn = 24

250 μgn = 28

p < 0.001

p = 0.007

p = 0.003

617.5 mg

471.2 mg

62.8 mg

* Excluding missing data

Me

an

CR

D in

cre

ase

(95%

CI)

4-5 peanuts

Page 15: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

VIPES Immunological Changes in Children (Ages 6-11) Supports Treatment Effect

Peanut-specific IgG4 (mg/L)Peanut-specific IgE (kU/L)

0 3 6 9 1 2

- 1 0 0

- 5 0

- 5 0

0

5 0

1 0 0

2 0 0

4 0 0

x 1 . 3

x 1 . 6

x 3 . 1

x 2 . 5

M T H0 3 6 9 1 2

- 1

0

1

2

3

4

5

6

7

1 0

1 5

x 1 . 3

x 5 . 5

x 1 9 . 1

x 7 . 2

M T H

15

Page 16: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

OLFUS-VIPES: Open-Label Follow-Up Trial to VIPESExtension Trial to Support Use of Viaskin Peanut

M0 M12 M12 M24 M26

Placebo

50 µg

100 µg

250 µg

VIPES Dose-finding

250 µg221 stratified patients, 22 centers in US, Canada, France, Poland, and Netherlands

OLFUS-VIPESOpen Label Follow-Up Study

16

M0

171 patients opted to enroll in OLFUS (overall 83% roll-over rate from VIPES)

― 97 children and 74 adolescents & adults

Assessed long-term safety and efficacy

Double-Blind Placebo-Controlled Food Challenge (DBPCFC) administered at month-12 and month-24

Month-26 DBPCFC to explore “sustained unresponsiveness”

― Patients unresponsive to CRD* > 1,440 mg at month-24 DBPCFC were eligible to continue study

― Two-month period without treatment or consumption of peanut to assess durability of response

*CRD: Cumulative Reactive Dose at Food ChallengeDenotes a completed food challenge

Page 17: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

OLFUS-VIPES Long-Term Follow-Up Data Key ConclusionsLate Breaking Oral Presentation at AAAAI 2017

In children treated for three years with a 250 µg dose there was a trend of progressive response to treatment as measured by increased response rate, higher CRD* and serological changes

― Treatment benefit was observed to be long-lasting for three years

No decreased compliance or increased frequency of AEs in VIPES patients treated for 24 additional months

― 95.5 % overall compliance rate was observed throughout the study

― No SAEs or epinephrine use due to treatment was reported in 36 months

― Most adverse events were related to application site and were mild to moderate, with decreasing severity and frequency over time

17

*CRD: Cumulative Reactive Dose at Food Challenge

Shreffler et al. AAAAI 2017, #L7

Page 18: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

OLFUS-VIPES Results, Ages 6-11Significant Increase in Peanut Consumption and Sustained Treatment Benefit after 36 months of Viaskin Peanut 250 μg

18

* 1 child discontinued (not related to Viaskin Peanut)** 2 children discontinued (none related to Viaskin Peanut)***CRD: Cumulative Reactive Dose at Food Challenge

Response Rate at OLFUS: baseline, year-1 and year-2

OLFUS Patients Change in CRD***

Excluding missing data

n = 2 0 * n = 1 8 * *n = 2 1

O L F U S b a s e lin e O L F U S y e a r 1 O L F U S y e a r 2

5 7 .1 %

(1 2 / 2 1 )

8 0 .0 %

(1 6 / 2 0 )

8 3 .3 %

(1 5 / 1 8 )

0 m g

1 ,0 0 0 m g

2 ,0 0 0 m g

3 ,0 0 0 m g4 ,0 0 0 m g5 ,0 0 0 m g

M e d ia n = 4 4 m g

M e d ia n = 4 4 4 m g

M e d ia n = 1 ,4 4 0 m g

O L F U S b a s e lin e

n = 2 1

O L F U S y e a r 1

n = 2 0

V IP E S b a s e lin e

n = 2 1

8 4 .5 m g

1 ,0 6 7 .8 m g

1 ,8 8 3 .5 m g

M e a n 9 5 % C I

O b s e r v e d v a lu e s , IT T

O L F U S y e a r 2

n = 1 8

2 ,4 5 3 .9 m g

M e d ia n = 1 ,4 4 0 m g

Page 19: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

OLFUS-VIPES Results, Ages 6-11Biomarkers Reflect Strong Immunomodulation

19

Median relative change = 100 x (Month xx – Baseline)/BaselineViaskin Peanut 250 µg, n=18

0 3 6 9 1 2 1 5 1 8 2 1 2 4 2 7 3 0 3 3 3 6

-5 0

0

5 0

1 0 0

M o n th s

R e la t iv e c h a n g e Ig E

M e d ia n IQ

3 6 9 1 2 1 5 1 8 2 1 2 4 2 7 3 0 3 3 3 6

0

5 0 0

1 ,0 0 0

2 ,0 0 0

3 ,0 0 0

4 ,0 0 0

M o n th s

R e la tiv e C h a n g e Ig G 4

M e d ia n IQ

Page 20: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

20

Defined Endpoints

Primary endpoint: Proportion with a treatment success following 52 weeks of blinded treatment– Passing a 5044 mg OFC* to peanut protein at week 52 OR ≥ 10-fold increase in the successfully

consumed dose (SCD) of peanut protein at week 52 compared to baseline OFC Secondary endpoints: – Comparison of Viaskin Peanut 100 µg vs Viaskin Peanut 250 µg doses at week 52– Desensitization and sustained unresponsiveness at week 130– Incidence of all adverse events– Changes in immune markers

75 patients; 4-25 years of age; Confirmed peanut allergy by SPT/slgE levels

Randomization1:1:1

Enrollment N=75

Entry OFC positive to cumulative

dose of <1044 mg peanut

protein

Placebo

100 mg Peanut EPIT

250 mg Peanut EPIT

Week 525044 mg OFC Week 130

5044 mg OFC[End of study]

250 mg Peanut EPIT

Jones S et al. (AAAAI Session 1201)

CoFAR6 (Phase II)Efficacy and Safety – NIAID sponsored

*OFC: Oral Food Challenge

Page 21: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

All patients 4 – 11 years

Tr

ea

tm

en

t s

uc

ce

ss

(%

)

0

5 0

1 0 0

p < 0 . 0 0 1

p < 0 . 0 0 1

P l a c e b o

n = 1 8

1 0 0 µ g

n = 1 7

2 5 0 µ g

n = 1 8

5 . 6 %

5 8 . 8 %6 1 . 1 %

Tr

ea

tme

nt

su

cc

es

s (

%)

0

5 0

1 0 0p = 0 . 0 0 5

p = 0 . 0 0 3

P l a c e b o

n = 2 5

1 0 0 µ g

n = 2 4

2 5 0 µ g

n = 2 5

1 2 . 0 %

4 5 . 8 %4 8 . 0 %

Primary endpoint Pre specified analysis No SAEs or Epinephrine due to drug

96% compliance

Primary endpoint met (p=0.003)

Significant age bytreatment interaction

~1/3 of children treated with 250 µg were able to tolerate > 1,000 mg protein (~4 peanuts)

Significant increase in IgG4

Jones S et al. (AAAAI Session 1201)

CoFAR6 Trial: Primary Endpoint Was MetFindings Reaffirm VIPES Results

21

Page 22: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

250 µg 250 µg

356 peanut allergic children US, Canada, Australia, Germany, Ireland

M0 M12 M36

Highly allergic patients ages 4-11

o > 0.7 kUI/ L peanut-specific IgE and ≥ 8 mm SPT* wheal

o Reactive dose at M0 ≤ 300 mg peanut protein (i.e. approx 1 peanut)

Efficacy Endpoints

Primary endpoint at M12

Treatment responders (%) in active group compared to placebo at DBPCFC**:

o For subjects with a M0 ED*** ≤ 10mg: responder if ED ≥ 300 mg at M12

o For subjects with a M0 ED > 10mg: if ED ≥ 1,000 mg at M12

Main secondary endpoints: CRD****, LS Mean, changes in peanut sIgE and sIgG4

Study Population

* SPT: Skin Prick Test**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

PEPITES: Pivotal Phase III Global Trial Recruitment Completed Ahead of Schedule – Upsized Due to Patient Demand

22

PEPITES Open Label Follow Up

Placebo 250 µg

M36M12

Page 23: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

VIPES Post Hoc Analysis Using PEPITES Responder DefinitionDecreasing Placebo Rate to Increase Treatment Magnitude

Reported Response Rate

% o

f re

spo

nd

ers

(95%

CI)

VIPES Response Rate using the PEPITES Response Criteria

6.5%

46.4%

0%

10%

20%

30%

40%

50%

60%

70%

80%

Placebon = 31

250 µgn = 28

p= 0.0007

19.4%

53.6%

0%

10%

20%

30%

40%

50%

60%

70%

80%

Placebon = 31

250 µgn = 28

p= 0.0076

VIPES Children (6-11 years) - Viaskin 250 μg at M12

% o

f re

spo

nd

ers

(95%

CI)

23

Page 24: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

250 µg

250 µg

393 peanut allergic children 32 centers in North America

M0 M6 M24 M36

Patients 4 to 11 with history of IgE-mediated reactions to peanut

o 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 M6o Treatment Emergent Adverse Events

No oral food challenges are required at baseline Exploratory endpoints

o Quality of Life Questionnaires (FAQLQ & FAIM)

o Evolution of peanut-specific serological markers over time (IgE, IgG4, SPT wheal)

Study Population

Phase III REAL LIfe Use and Safety of EPIT (REALISE)Enrollment Completed; Higher than Expected Patient Demand

24

Open Label

Placebo

M12Safety

Endpoint

Safety checkpoint

Safety checkpoint

Safety checkpoint

* SPT: Skin Prick Test

Page 25: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

Part A: ~50 patientsPlacebo (n=10)100 µg (n=20)250 µg (n=20)

M0 M3

Children ages 1-3 with peanut allergy

o > 0.7 kUI/ L peanut-specific IgE and ≥ 6 mm SPT* wheal

o Reactive dose at M0 ≤ 300 mg peanut protein

Efficacy Endpoints

Primary endpoint at M12

Treatment responders (%) in active group compared to placebo at DBPCFC:

o For subjects with a M0 ED** ≤ 10mg: responder if ED ≥ 300 mg at M12

o For subjects with a M0 ED > 10mg: if ED ≥ 1,000 mg at M12

Main secondary endpoints: CRD***, changes in peanut sIgE and sIgG4

Study Population

EPITOPE: Planned Phase III Global Trial in Children Ages 1-3 To Start in 1H 2017

25

DSMB

* SPT: Skin Prick Test, ** ED: Eliciting Dose ,*** CRD: Cumulative Reactive Dose at Food ChallengeDenotes a pending food challenge

Highest safe dosen=127

Placebon=64

If no safety concerns, patients remain on dose from Part A

Part B: ~191 additional patients

M12

Page 26: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

Viaskin Milk: MILES Phase IIbRecruitment Completed

Efficacy Endpoints

Study Population

2-17 years old Highly sensitive to milk (positive milk-specific IgE and SPT*): reactive dose at baseline (M0)

≤300 mg cow’s milk protein (‘CMP’) (i.e. ~ ≤9.4 mL of CMP)

Primary endpoints: ≥ 10-fold increase in CRD** at M12 and at least 144 mg of CMP ORCRD ≥ 1,444 mg at M12

Main secondary endpoints include change from baseline in IgE, IgG4

Pediatric Phase I/IIa USA & Canada

Part A: 18 patientsPart B: 180 patients

Phase I (Part A)

Cohort at 150µg dose

Cohort at 300µg dose

DSMB

FDA & DSMB

Cohort at 500µg dose

DSMB

M0

Placebo

Highest safe dose

M12 M24

300 µg

150 µg

500 µg

Phase II (Part B)

26

* SPT: Skin Prick Test** CRD: Cumulative Reactive Dose at Food Challenge

Denotes a completed food challenge; Denotes a pending food challenge

Page 27: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

Leveraging the Viaskin Immunotherapy PlatformPotential Product Candidates & Indications

Allergies Peanut Milk Hen’s Egg

Allergic Diseases EoE

Prevention Allergic march and asthma prevention

Autoimmune Celiac Refractory Hemophilia A Type I Diabetes

Inflammatory IBD

Vaccines Pertussis boost RSV

Diagnostics Pediatric CMPA (Nestlé Health Science partner)

27

Page 28: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

Where We Are TodayUpcoming Milestones

1H

’17

28

2H

’17

Completion of recruitment for SMILEE Phase IIa study of Viaskin Milk for EoE

Data presented at AAAAI 2017 including full OLFUS-VIPES results for Viaskin Peanut

Completion of recruitment for REALISE trial of Viaskin Peanut

Results from Viaskin rPT pilot proof of concept trial

o Launch of Viaskin Peanut trial in children ages 1-3

o Poster presentations expected at EAACI 2017

o PEPITES Phase III results for Viaskin Peanut expected

o REALISE Phase III results for Viaskin Peanut expected

o MILES Phase IIb results for Viaskin Milk expected

o SMILEE Phase IIa results for Viaskin Milk for EoE expected1H

’18

Page 29: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

Electrospray Proprietary Technology Patented and Wholly-Owned Manufacturing Process

Deposits very small & precise quantities of API on Viaskin, devoid of adjuvants

Stored at room temperature, providing a long shelf life

Scaled-up GMP manufacturing process to annual production capacity of 30 million patches per GEN-4.0 machine

Fully designed & engineered by DBV

29

GEN-4.0 DBV Electrospray Machine

Page 30: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

DBV Technologies Key Financial Data

30

Cash position as of March 31, 2017:

― € 227.0m

Ticker:

― Nasdaq: DBVT

― Euronext Paris: DBV

Share Capital:

― Ordinary shares* (Euronext Paris):

― Current: 24.7m

― Fully Diluted: 27.3m

― American Depository Shares (Nasdaq):

― Each ADS represents 0.5 ordinary shares

*as of March 31, 2017

Page 31: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

Appendix

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Page 32: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

Measuring EfficacyDouble-Blind Placebo-Controlled Food Challenge

Standardized GMP challenge matrix1

Standardized semi-logarithmic increase of peanut protein doses (DBPCFC2 as per PRACTALL3)

Allergic symptoms are graded from a standardized published protocol4

Challenge stopped by clear objective symptoms

1Cochrane et al, Allergy 2012 2Double-Blind, Placebo-Controlled Food Challenge

3Sampson et al, JACI 20124Nowak-Wegrzyn et al, JACI 2009

1 mg 10 mg3 mg 30 mg 100 mg 300 mg

32

Page 33: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

VIPES: Primary Efficacy Endpoint MetIdentified Viaskin 250 µg as Phase III Dose

Response rate across doses after 12 months

25.0%

45.3%41.1%

50.0%

0%

10%

20%

30%

40%

50%

60%

70%

Placebon = 56

50 µgn = 53

100 µgn = 56

250 µgn = 56

% o

f re

spo

nd

ers

(95%

CI)

p= 0.0108

p= 0.1074

p= 0.0292

33

Page 34: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

VIPES: Children, Ages 6-11

Increased Criteria Stringency Supports Strong Efficacy

34

Proportion of strong responders in children (both x10 and 1,000 mg increase in ED)

0.0%

17.9%

26.9%32.1%

0%

5%

10%

15%

20%

25%

30%

35%

Placebon = 31

50 µgn = 28

100 µgn = 26

250 µgn = 28

p = 0.0005p = 0.0025

p = 0.0196

# of children with no objective symptoms during highest dose of M12 DBPCFC

0 0 1 4

% o

f re

spo

nd

ers

(95%

CI)

Page 35: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

Subjects aged 12-55 response rate across doses

VIPES: Adolescents & Adults

High Placebo Response Rate Distorts Analysis

32.0% 32.0%

36.7%

46.4%

0%

10%

20%

30%

40%

50%

60%

70%

Placebon = 25

50 µgn = 25

100 µgn = 30

250 µgn = 28

% o

f re

spo

nd

ers

(95%

CI)

p= 0.3998

p= 0.7812p= 1.0000

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Page 36: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

VIPES: Adolescents & Adults

Changes from Baseline CRD Indicate Dose Response Trend

500 mg

1,000 mg

0 mg

1,500 mg

250 μgn = 28

100 μgn = 30

50 μgn = 25

Placebon = 25

837.4 mg

Median = 0.0Median = 10.0 Median = 30.0

Median = 335.0

842.3 mg

619.2 mg

528.4 mg

Subjects aged 12-55 increase in baseline CRD at 12 months across doses

Me

an

CR

D in

cre

ase

(95%

CI)

36

Page 37: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

VIPES: Adolescents & AdultsImmunological Changes Support Dose Response Trend

Peanut-specific IgG4 (mg/L)Peanut-specific IgE (kU/L)

37

Me

dia

n

IQ

R

0 3 6 9 1 2

0

5 0

1 0 0

1 0 0

2 0 0

3 0 0

4 0 0

x 1 . 4

x 2 . 0

x 2 . 0

x 1 . 7

M T H

Me

dia

n

IQ

R

0 3 6 9 1 2

0 . 0

0 . 5

1 . 0

1 . 5

2

3

4

x 1 . 6

x 3 . 7

x 5 . 3

x 3 . 5

M T H

Page 38: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

Cow’s Milk EPIT in Children (JACI 2010):A Pilot Trial

Dupont C et al. JACI 2010

48h application, 3/weekNb treated pt=9, Nb placebo pt=73-month treatment

Volume of Milk tolerated before symptoms appear (ml)

0 . 1

1

1 0

1 0 0

O F C 1 - T 0 O F C 2 - 3 m o n t h s O F C 3 - 6 m o n t h s

4 7 . 0

2 7 . 1

1 7 . 1

1 5 . 0

1 . 6

0 . 3 5

1 . 6

1 . 7

4 . 1

1 7 . 1

3 . 6

4 . 1

0 . 7

0 . 6

0 . 3

1 7 . 1

9 . 1

0 . 1

1

1 0

1 0 0

O F C 1 - T 0 O F C 2 - 3 m o n t h s O F C 3 - 6 m o n t h s

2 7 . 1

2 0 . 0

1 0 . 0

9 . 19 . 1

4 . 1

0 . 6

1 . 3

1 . 6

4 . 1

2 5 . 5

4 7 . 1

6 4 . 66 7 . 1

9 . 1

3 . 6

1 . 6

0 . 6

0 . 6

0 . 1

Active group Placebo group

38

Page 39: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

Next Generation Allergy Treatments: Prophylaxis JACI 2015 – Disrupting the Allergic March in Young Mice

Mondoulet et al, 2014. JACI

Sham

Sensitization to PPE

D0 D43 D99 D127 D130

n = 10

n = 10

n = 10

n = 10

EPIT 100

Naive

Sensitization to PPE

Positive Control

SENSITIZATION - PPE (IG) IMMUNOTHERAPY SENSITIZATION MILK + CT

(6 ig for 6 weeks)

anaphylaxis measured by the drop in temperature + increase

of plasma mMCP1

IV CHALLENGE TO PEANUT

39

Page 40: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

Next Generation Allergy Treatments: Prophylaxis JACI 2015: Anaphylaxis Results after Second Sensitization

Sensitization to Milk/ Milk-EPIT® / Sensitization to peanut

IV challenge to peanut

Mondoulet et al, 2014. JACI

n a iv e c o n tro l+ S h a m E P IT

0

2

4

6

8

Te

mp

era

ture

dro

p (

°C

)

***

M a n n -W h itn e y n o n p a ra m e tr ic te s t

n a iv e v s S h a m , p = 0 .0 1 5 9

n a iv e v s c o n t ro l+ , p = 0 .0 0 7 9

E P IT v s S h a m , p = 0 .0 0 7 9

E P I T v s c o n tr o l+ , p = 0 .0 0 7 9

n a iv e v s E P I T , p = 0 .4 1 2 7

**

**

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Page 41: The Epicutaneous Immunotherapy Company - Jefferies...DBV Technologies Today Recent Progress 3 Viaskin Peanut –Phase III data expected in 2H 2017―Pivotal Phase III recruitment completed

IP ProtectionMethod, Technology, Manufacturing Processes, & Applications

ManufacturingAllergy

Vaccination Immune disease

BOOST HBS AgTH1-directed

response

CONDENSATIONCHAMBER

PeanutEczema

Eosinophilic Esophagitis

HEMOPHILIA A

ELECTROSPRAY

VIASKIN® II:Chamber,

Electrostatic API deposit

VIASKIN® I: Dry patch Architecture, electrostatic

forces, adhesive crown

Core Technology

EPIT

EPIT Immuno Rebalancing

Allergic march

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