Allergene
Allergene
As of the date of this presentation, EPIT™ and DBV’s Viaskin™ technology platform are investigational and have not yet been approved by the U.S. Food and Drug Administration
(FDA), European Medicines Agency (EMA), or any other regulatory agencies. Some of the information contained herein regarding EPIT or Viaskin is or may be under review by FDA,
EMA and other regulatory agencies as part of a biologics license application (or equivalent) and is subject to change based on such review.
Well Financed
We are dedicated to improving the lives of
Well financed with $212.7 million of cash and equivalents as of September
patients with food allergies and other
30, 2022
immunological diseases
DBV Technologies | Corporate Overview 3
Committed to Generating Long-term Viaskin™ Data to Inform Real-Life Use
Completed and Currently Ongoing Clinical Trials*
Viaskin Milk (DBV135) – Cow’s Milk Allergy MILES: Ages 2-17 years
* Phase I and Phase IIb trials of Viaskin Peanut are not included here. Complete Ongoing Planned
EPIT=epicutaneous immunotherapy; PEPITES=Peanut EPIT Efficacy and Safety Study; PEOPLE=PEPITES Open Label Extension Study; REALISE=Real Life Use and
Safety of EPIT; VITESSE=Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy; EPITOPE=EPIT in Toddlers with Peanut Allergy;
EPOPEX=EPITOPE Open Label Extension Study DBV Technologies | Corporate Overview 4
In the US, More Children Are Living With Peanut Allergy Than Ever Before
Approximately ~75% will not outgrow their allergy1
1. Savage J, et al. J Allergy Clin Immunol Pract. 2016;4:196-203. 2. Gupta RS, et al. Pediatrics. 2018;142:e20181235. 3. DBV Data on File. DBV Technologies | Corporate Overview 5
For Many Families, Avoidance Is Not Enough
• Accidental exposures still happen despite families’ best efforts1
• Approximately 35% of caregivers and 42% of children report that their peanut
allergy interferes with their daily life7
There Are Multiple Unmet Needs • Nearly 80% of peanut-allergic children report that fear of accidental exposure
Concerning The Management Of impacts their emotional well-being7
1. Capucilli P, et al. Ann Allergy Asthma Immunol. 2020;124:459-465. 2. Kansen HM, et al. J Allergy Clin Immunol. 2020;145:705-707.e7. 3. Gupta RS, et
Peanut Allergy al. Pediatrics. 2018;142:e20181235 4. Turner PJ, et al. Allergy. 2016;71:1241-1255. 5. Shaker MS, et al. Curr Opin Pediatr. 2017;29:497-502. 6. Blaiss
MS, et al. J Manag Care Spec Pharm. 2021;27:516-527.
7. Nowak-Wegrzyn A, et al. World Allergy Organ J. 2021 Feb 15;14(2):100512
DBV Technologies | Corporate Overview 6
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
1. Chu DK et al. Oral immunotherapy for peanut allergy (PACE): a systematic review and meta-analysis of efficacy and safety. Lancet. 2019 Jun 1;393(10187):2222-2232. 2. . Based on primary market
research conducted on behalf of DBV among 100 allergists in the United States conducted in May 2022. Survey question: Do you see the need for additional options in the treatment of pediatric peanut allergy?
DBV Technologies | Corporate Overview 8
Target Product Profile: A Treatment That Can Be Incorporated into the Busy Lives
of Families
Viaskin Peanut:
EPIT™ and DBV’s Viaskin™ technology platform are investigational and have not yet been approved by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or any other
regulatory agencies DBV Technologies | Corporate Overview 9
The Viaskin™ Patch: Our Innovative Approach to Epicutaneous Immunotherapy
A Novel Drug-Device Combination For Delivering Allergen Immunotherapy
Adhesive Overlay
1. Dioszeghy V, et al. J Immunol. 2011;186:5629-5637. 2. Mondoulet L, et al. Immunotherapy. 2015;7:1293-1305. 3. Fleischer DM, et al. Allergy Asthma Proc. 2020; 41(5):326-335. DBV Technologies | Corporate Overview 10
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 response
B cell
Decrease in allergen-specific IgE
Induction of IgG4
Allergen
Regulatory
Epidermis
T Cells Suppression of inflammatory DCs
DC
Induction of tolerogenic DCs
Dermis
Antigen
Presenting Cell Suppression of Th2 and other allergen-specific
Th2
effector T cells
Basophils
Eosinophils
DC=dendritic cell; IgE=immunoglobulin E; IgG4=immunoglobulin G4; Th2=T-helper 2 cell.1. Mondoulet L, et al. J Allergy Clin Immunol. 2015;135:1546-57. 2. Mondoulet L, et al. Allergy. 2019;74:152-
164. 3. Moingeon P, Mascarell L. Sem Immunol. 2017;30:52-60. 4. Feuille E, Nowak-Wegrzyn A. Allergy Asthma Immunol Res. 2018;10:189-206. 5. Tordesillas L, et al. Immunity. 2017;47(1):32-50. 6.
Dioszeghy V, et al. Cell Mol Immunol. 2017;14:770-782. DBV Technologies | Corporate Overview 11
Viaskin™ Uses Minimal Amounts of Allergen to Induce an Immune Response1-3
1. Dioszeghy V, et al. J Immunol. 2011;186:5629-5637. 2. Mondoulet L, et al. Immunotherapy. 2015;7:1293-1305. 3. Mondoulet L, et al. Clin Transl Allergy. 2012;2:22. DBV Technologies | Corporate Overview 12
13
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 symptoms1: determined by two factors2: a patient’s eliciting dose is less than an
exposure dose3
How much food was consumed?
Reaction Predicted No Reaction Predicted
500 mg 500 mg
Eliciting Dose 30 mg
0 mg 0 mg
1. Sampson HA, et al. J Allergy Clin Immunol. 2012;130:1260-1274. 2. Blom WM, et al. Food Chem Toxicol. 2019;125:413-421. 3. Baumert JL, et al. J Allergy Clin Immunol Pract. 2018;6:457-465.e4.
DBV Technologies | Corporate Overview 14
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 before allergen
10 mg
immunotherapy
1 mg
1. Baumert JL, et al. J Allergy Clin Immunol Pract. 2018;6:457-465. DBV Technologies | Corporate Overview 15
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
M36
M0 M12 DBPCFC
DBPCFC DBPCFC
PEPITES Primary efficacy endpoint: difference between the percentage of PEOPLE Primary outcome measures: % of subjects originating from the active
treatment responders in the active vs. placebo group after 12 months arm of PEPITES reaching an Eliciting Dose (ED) ≥ 1,000 mg after 24 months of
additional treatment in PEOPLE
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 M12
DBPCFC=double-blind, placebo-controlled food challenge; CRD=cumulative reactive dose; ED=eliciting dose; PEOPLE=PEPITES Open-Label Extension Study; PEPITES=Peanut EPIT Efficacy and Safety Study;
* Confirmed peanut allergy by SPT ≥6 mm for 4- to 5-year-olds or ≥8 mm for 6- to-11-year-olds and slgE levels (>0.7 kUA/L)
DBV Technologies | Corporate Overview 16
1. Fleischer DM, et al. JAMA. 2019;321:946-955. 2. Fleischer DM, et al. J Allergy Clin Immunol. 2020;146:863-874.
Viaskin™ Peanut Treatment Achieved Clinically Meaningful Changes In
Eliciting Dose (ED) After 1 Year
Primary efficacy outcome showed statistically significant treatment benefit
28.0%
Percent of Responders (%)
P<0.001
40% 80%
6.7%
0% 0%
Placebo VP250 Placebo VP250
(N=118) (N=238) (N=118) (N=238)
The prespecified 15% lower bound of the 95% CI of the difference between An increase in ED was >4 times more likely to occur in the Viaskin Peanut group
treatment groups was not met. The clinical relevance of this is not known. compared with placebo
†Based on ITT population; missing data calculated using mBOCF. DBPCFC=double-blind, placebo-controlled food challenge; ED=eliciting dose.
Source: Fleischer DM, et al. JAMA. 2019;321:946-955 DBV Technologies | Corporate Overview 17
Changes in ED Maintained or Improved Over 3 Years in the Majority of
Subjects in the Open-Label Extension Study1
M0 M12 M36
75.9% of subjects demonstrated an increase in ED from baseline
c
>2000* 4 18 to Month 36
2000 14 6
13.5% of subjects were able to tolerate the full DBPCFC of 5,444
1000 22 27 c
mg (~18 peanuts) at Month 36
300 35 32 25
100 40 23 16
77.8% (14/18) of subjects who completed the oral food challenge
c
30 12 5 4 at Month 38 maintained desensitization with an ED ≥ 1,000 mg*.
10 10 2
Food Allergy Quality of Life (QoL) Assessment in PEPITES, PEOPLE3
3 3 1 Based on validated food allergy QoL questionnaires, children experienced
1 statistically significant QoL improvements after 2 years of Viaskin Peanut
treatment
ED=eliciting dose DBPCFC=double-blind, placebo-controlled food challenge.
* All participants who reached an ED ≥ 1,000 mg at Month 36 were eligible to continue the study for two additional months without treatment while maintaining a peanut-free diet. A further double-blind
placebo-controlled food challenge to determine ED was administered at the end of this period (Month 38). Similar sustained unresponsiveness results reported Phase IIb program.4 DBV Technologies | Corporate Overview 18
1. Fleischer DM, et al. J Allergy Clin Immunol. 2020;146:863-874. 3. DunnGalvin A et al. J Allergy Clin Immunol Pract. 2021;9:216-224.e1. 4. . Sampson HA, et al. JAMA. 2017;318:1798-1809.
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 μg versus placebo was demonstrated
40%
40.0%
30%
• 40.0% of subjects in the Viaskin Peanut 250 μg arm were responders compared
Δ= 30.8%
(95% CI: 18.3, 40.8)
with 9.2% in the placebo arm, with a risk difference of 30.8% (95% CI: 18.3–
20%
40.8; P<0.001)
10%
9.2%
0% • In comparison, the difference in the proportion of treatment responders between
Placebo VP250
(N=118) (N=238) Viaskin Peanut and placebo subjects aged 8–11 years was 11.2% (95% CI: -3.4–
23.4)
ED ≥1,000 mg at Month 12
Children Ages 4-7 Years
• Furthermore, among subjects aged 4–7 years, 35.2% in the Viaskin Peanut 250 μg
50%
arm versus 7.7% in the placebo arm reached an ED of ≥1000 mg at Month 12
40%
30% 35.2% The safety profile in the subgroup of children aged 4–7 years was consistent
20% with that observed in the overall 4 to 11-year-old PEPITES population
10%
7.7%
0%
Placebo VP250
(N=118) (N=238)
1. Efficacy of Epicutaneous Immunotherapy with ViaskinTM Peanut for 4-7 Year-Old Peanut-Allergic Children in a Phase 3 Clinical Trial (PEPITES). David Fleischer, MD Presented at Canadian Society for
Allergy and Clinical Immunology Annual Meeting, September 2022. DBV Technologies | Corporate Overview 19
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)
• Serious Treatment-Emergent AEs (TEAEs) were experienced by 1.1% of Viaskin Peanut 250 µg subjects and 1.8% of placebo subjects
• TEAEs leading to permanent discontinuation occurred in 1.1% of patients treated for 6 months with Viaskin™ Peanut vs 0% with placebo
“A well-tolerated treatment approach with a favorable benefit: risk profile could afford those with peanut allergy a
Conclusion valuable therapeutic option for managing this serious condition”1
*Identified through the algorithm of the Anaphylactic Reaction SMQ (Standardized MedDRA [Medical Dictionary for Regulatory Activities] Queries)
RDBPC = Randomized Double-Blind Placebo-Controlled 1. Pooled Safety Data from Phase 3 Studies of Epicutaneous Immunotherapy for Peanut Allergy in Children Aged 4-11 Years – Rachel Robison, MD.
Presented at presented at AAAAI Annual Meeting, February 2022 DBV Technologies | Corporate Overview 20
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
DBV selected the modified Viaskin Peanut patch based on adhesion data from
a Phase I trial of five modified patches in healthy adult volunteers2
1. DBV Technologies Press Release August 4, 2020; 2. DBV Technologies Press Release August 2, 2021; 3. DBV Technologies Press Release December 20, 2021 DBV Technologies | Corporate Overview 21
22
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.
VITESSE=Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy’ FDA=United States Food and Drug Administration; DBV Technologies | Corporate Overview 23
FDA Stated VITESSE May Proceed with Protocol Revisions That Addressed
Agency’s Requested Modifications
Statistical Test for Patch DBV and the FDA agreed a statistical test of adhesion will be included in the VITESSE statistical analysis plan and further
Adhesion Assessment considered patch adhesion data collection and interpretation in the context of the novel nature of the Viaskin patch platform.
Reclassification of Adverse Four adverse events will be classified as adverse events of special interest. These AEs were collected and assessed in all
Events of Special Interest previous Viaskin Peanut trials and included in the previous VITESSE protocol. Only the classification of these AEs has changed.
Increase in Number of Trial DBV plans to initiate a separate safety study in approximately 275 additional subjects, randomized 3:1 active versus placebo.
Participants on Active The additional safety data generated by this six-month study will supplement the safety data generated by the VITESSE trial,
Treatment resulting in a safety database comprised of approximately 600 children ages 4 – 7 years treated with Viaskin Peanut.
Source: DBV Technologies Press Release December 23, 2022 DBV Technologies | Corporate Overview 24
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 Peanut
Global Phase 3 Trial
250 µg
Randomized, double-blind, placebo-controlled
Primary endpoint:
difference between the percentage of treatment responders in the active vs. placebo group after 12 months
M = Month, DBPCFC = Double Blind Placebo Controlled Food Challenge DBV Technologies | Corporate Overview 25
Summary
Efficacy endpoint success criterion Lower bound of 95% confidence interval ≥ 15% Lower bound of 95% confidence interval ≥ 15%
Size 600 subjects, randomized 2:1 356 subjects, randomized 2:1
Supplementary Safety Study 275 additional subjects, randomized 3:1 REALISE (393 patients)
*The
DBV Technologies | Corporate Overview 26
size of the condensation chamber is identical in both patches, as is the composition of the overlay
27
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 in US, Canada, Europe, Australia
M0 M12
DBPCFC DBPCFC
Primary endpoint:
difference between the percentage of treatment responders in the active
compared to the placebo group after 12 months
Baseline 1 mg 3 mg 10 mg 30 mg 100 mg 300 mg
Treatment responder (assessed by DBPCFC) defined as:
If ED ≤10 mg at baseline, responder if ED ≥300 mg at M12 Month 12 1 mg 3 mg 10 mg 30 mg 100 mg 300 mg 1,000 mg 2,000 mg
80%
80%
P<0.001 70% P<0.001
70%
95% CI lower bound of 22.4% ≥ 15% → Regardless of baseline ED, a statistically significantly larger percentage
Primary endpoint is met of participants on VP250 achieved an ED ≥ 1,000 mg
CI=confidence interval; ED=eliciting dose; ITT=intent to treat population; M=month; VP250=Viaskin Peanut 250 µg.
1. EPITOPE Study Results: Phase 3, Randomized, Double-blind, Placebo-controlled Study of Epicutaneous Immunotherapy in Peanut-allergic Toddlers – Matthew Greenhawt, MD. Oral Presentation at ACAAI
Annual Meeting November 2022 DBV Technologies | Corporate Overview 29
Shift Toward Reduction in Reaction Severity Following 12 Months of
Viaskin Peanut Treatment1
60% 51.0%
At Month 12, the distribution of maximum symptom severity
was significantly shifted toward less severe symptoms in the 51.0%
40% 68.4% 71.0%
Viaskin Peanut 250 µg (VP250) group relative to placebo
(P<0.001). 20.5%
20%
14.3%
16.0%
This shift toward a reduction in reaction severity coincided 0% 6.1% 6.0% 6.1%
with an increase in eliciting dose (ED) and a greater Placebo VP250 Placebo VP250
proportion of responders in the Viaskin Peanut 250 µg Baseline Month 12
group versus the placebo group.
Absent Mild Moderate Severe
CI=confidence interval; ED=eliciting dose; ITT=intent to treat population; M=month; VP250=Viaskin Peanut 250 µg.
1. Reduction in Reaction Severity Following 12 Months of Epicutaneous Immunotherapy with Peanut Patch in Toddlers – Terri Brown-Whitehorn, MD. Poster Presentation at ACAAI Annual Meeting November 2022
DBV Technologies | Corporate Overview 30
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 related to IMP (VP250 vs placebo): 1 case of mild periorbital edema 0.4% vs 0%
Anaphylactic reaction related to IMP (VP250 vs placebo): No severe events (3 moderate and 1 mild) 1.6% vs 0%
Any Adverse Event leading to epinephrine intake considered related to IMP (VP250 vs placebo) 1.2% vs 0%
IMP=investigational medicinal product; TEAE=treatment-emergent adverse event; VP250=Viaskin Peanut 250 µg.
1. EPITOPE Study Results: Phase 3, Randomized, Double-blind, Placebo-controlled Study of Epicutaneous Immunotherapy in Peanut-allergic Toddlers – Matthew Greenhawt, MD. Oral Presentation at ACAAI Annual
Meeting November 2022 DBV Technologies | Corporate Overview 31
Two Potential Regulatory Pathways for Viaskin™ Peanut
Flexibility of Viaskin manufacturing process supports potential for two in-market patches
• FDA guidance on
potential regulatory
pathway
1-3 years old
• VITESSE enrollment
*Patch images are for illustrative purposes only. Final patch design may be subject to modification. DBV Technologies | Corporate Overview 32
We Aim to Unlock the Powerful Immune
Properties of the Skin with our
Viaskin™ Platform
Viaskin – Vaccines
Decreased by ~65%3 for nine months ended September 30, 2002, versus comparable period in 2021
Cash runway
Notes: 1. Net of transaction costs; 2. French Crédit Impôt Recherche, or CIR; 3. Based on United States Generally Accepted Accounting Principles; 4. Based on current assumptions
ATM= At-the-Market; PIPE= private investment in public equity DBV Technologies | Corporate Overview 35
Near-Term Milestones
Well Financed
We are dedicated to improving the lives of
Well financed with $212.7 million of cash and equivalents as of September
patients with food allergies and other
30, 2022
immunological diseases
DBV Technologies | Corporate Overview 37
Investor Relations
Anne Pollak
+1 857-529-2363
[Link]@[Link]
Medical Information
medicalinformation@[Link]
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 peanut, including 250 µg
those with severe anaphylaxis
M0 M6 M12 M24 M36
32 centers in the US and Canada
Open-Label Extension
Confirmed peanut allergy by SPT (≥8 mm), Safety endpoint
and slgE levels (≥14 kU/L)
• REALISE met its primary endpoint in the 6-month blinded portion of the study, demonstrating that Viaskin Peanut was tolerated with
no new or unexpected AEs
• Preliminary results indicated that all study participants had a similar safety profile