Montrouge, France

Montrouge, France, June 7, 2022

DBV Technologies Announces Positive Topline Results from Phase 3 EPITOPE Trial of Viaskin Peanut in Peanut-Allergic Toddlers

DBV Technologies (Euronext: DBV ISIN: FR0010417345 Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced that

its pivotal Phase 3 trial EPITOPE (EPIT in TOddlers with PEanut Allergy), assessing the safety and efficacy of Viaskin Peanut 250 g for the

treatment of peanut-allergic toddlers ages 1 to 3 years, met its primary endpoint.

Viaskin Peanut demonstrated a statistically significant treatment

effect (p<0.001), with 67.0% of subjects in the Viaskin Peanut arm meeting the treatment responder criteria after 12 months, as compared to 33.5% of subjects in the placebo arm (difference in response rates = 33.4%; 95% CI = 22.4% - 44.5%).

DBV intends to further analyze the data from EPITOPE and explore regulatory pathways for Viaskin Peanut in children ages 1 to 3 years, given the high unmet

need and absence of approved treatments for this vulnerable population. Separately, DBV continues productive dialogue with the U.S. Food and Drug Administration (FDA) on the protocol design of VITESSE, a pivotal Phase 3 trial of the modified Viaskin

Peanut patch in peanut-allergic children ages 4 years and older.

Most peanut-allergic children are diagnosed between 1 to 3 years of age; however, there are

currently no FDA-approved therapies for this age group. Furthermore, there is growing evidence on the benefits of treatment from a younger age, said Dr. Hugh Sampson, Kurt Hirschhorn Professor of

Pediatrics at the Icahn School of Medicine at Mount Sinai, Director Emeritus of the Jaffe Food Allergy Institute and Chairman of the DBV Scientific Advisory Board. We believe these positive findings support the potential clinical benefit of

Viaskin Peanut in this important, and underserved, population.

These results represent the second and final part of the EPITOPE trial, which

enrolled 362 subjects ages 1 to 3 years, of which 244 and 118 were in the active and placebo arms, respectively. Enrollment was balanced for age and baseline disease characteristics between the active and placebo treatment arms. The median subject

baseline eliciting dose (ED) was 100 mg in each treatment arm. A double-blind, placebo-controlled food challenge (DBPCFC) was administered at baseline and month 12 to determine a subject s ED at each timepoint. A treatment responder was defined

as either a subject with a baseline ED 10 mg who reached an ED 300 mg of peanut protein at month 12, or a subject with a baseline ED >10 mg who reached an ED 1,000 mg of peanut protein at month 12.

In an additional pre-specified efficacy analysis, treatment response was defined as achieving an ED 1,000 mg of

peanut protein regardless of baseline ED. Using this response criterion, Viaskin Peanut demonstrated a statistically significant treatment effect (p<0.001), with 64.2% of subjects in the Viaskin Peanut arm meeting this treatment responder

criterion after 12 months as compared to 29.6% of subjects in the placebo arm (difference in response rates = 34.7%; 95% CI = 23.6% - 45.7%). The response rate observed in the placebo arm appears consistent with the approximately 22% natural

resolution rate in this patient population.1

The EPITOPE safety results were generally consistent

with the safety profile of Viaskin Peanut 250 g observed in children with peanut allergy ages 4 years and older in prior clinical trials. No imbalance in the overall adverse event (AE) rate was observed in the trial between the active and

Overall, 21 subjects (8.6%) in the Viaskin Peanut arm and 3 subjects (2.5%) in the placebo arm experienced a

serious adverse event (SAE). Only 1 of the SAEs (0.4%), which was mild periorbital edema (swelling around the eye) in the Viaskin Peanut arm, was deemed related to treatment.

The most commonly reported adverse events were skin reactions localized to the administration site, the majority of which were mild to moderate in nature.

Fifty-five subjects (22.5%) in the Viaskin Peanut arm experienced an application site reaction that was assessed as severe by an investigator compared with 10 subjects (8.5%) in the placebo arm. Based on investigators reported observations

from examinations of the skin at each study visit, using the skin grading systems defined in the protocol, the severity of administration site skin reactions following patch application decreased throughout the course of the 12-month treatment period.

Four (1.6%) subjects in the Viaskin Peanut arm experienced an anaphylactic reaction

determined to be related to, or possibly related to, treatment. Among these anaphylactic reactions, 3 resolved with a single dose of epinephrine and 1 resolved without epinephrine. All anaphylactic reactions were mild to moderate in severity and

were characterized mainly by skin and respiratory symptoms.

Eight subjects (3.3%) in the Viaskin Peanut arm discontinued due to adverse events.

In the 12-month treatment period, the trial completion rate was 84.8% and was balanced between the Viaskin Peanut and

placebo arms. Mean subject compliance to daily patch treatment was above 95% in both the active and placebo arms.

We are thrilled by the topline

results of EPITOPE, our second Phase 3 clinical trial to evaluate the safety and efficacy of Viaskin Peanut, said Dr. Pharis Mohideen, Chief Medical Officer of DBV Technologies. We are grateful to the toddlers and their parents,

caregivers and allergists who are contributing to a brighter future by having participated in this first-of-its kind trial.

Following the completion of EPITOPE, all eligible subjects had the option to rollover into EPOPEX, a long-term, open-label extension study of Viaskin Peanut.

There are currently 304 subjects (88% of all eligible subjects) enrolled in EPOPEX.

DBV plans to present full EPITOPE trial results at future medical

congresses as well as submit them for publication in a peer-reviewed journal.

The EPITOPE data advance our understanding of investigational epicutaneous immunotherapy s

ability to induce an immune response with minimal amounts of allergen, said Daniel Tass , Chief Executive Officer of DBV Technologies. These results further inform EPIT s potential in other food allergies and immunological

conditions, which are areas of research DBV remains highly committed to pursuing.

DBV will host a conference call and live audio webcast on

Tuesday, June 7, 2022, at 5:00 p.m. ET to discuss the results. This call is accessible via the below teleconferencing numbers, followed by the reference ID: 23143278#

A live webcast of the call will be available on the Investors & Media section of the Company s website:

https://www.dbv-technologies.com/investor-relations/. A replay of the presentation will also be available on DBV s website after the event.

EPITOPE (NCT03211247) enrolled 413

subjects (51 in Part A and 362 in Part B) in approximately 50 centers across North America (Canada and the United States), Europe and Australia. The EPITOPE trial is a two-part trial: Part A was designed to

assess the safety of Viaskin Peanut 100 g and 250 g and to determine the highest safe dose, and Part B was designed to assess the efficacy and safety of the selected dose. Based on the results of Part A, the 250 g dose was

selected for Part B. In Part B, subjects were randomized 2:1 to receive Viaskin Peanut 250 g or placebo.

The primary endpoint was based on a

responder analysis after 12 months of treatment with the selected dose of Viaskin Peanut. As a secondary efficacy endpoint, cumulative reactive dose (CRD) was also evaluated in EPITOPE to establish the total quantity of peanut protein that triggers

subject reactions at month 12 of active treatment versus placebo. Serological markers were also measured at baseline, 3, 6 and 12 months in order to characterize the immunological changes in subjects.

Following the completion of EPITOPE, all eligible subjects had the option to rollover into EPOPEX, a long-term, open-label extension study of Viaskin Peanut

250 g. Now that the EPITOPE study results are publicly available, subjects enrolled in the EPOPEX study will be unblinded to their respective treatment group in EPITOPE.

About DBV Technologies

DBV Technologies is developing Viaskin , an investigational proprietary technology platform with

broad potential applications in immunotherapy. Viaskin is based on epicutaneous immunotherapy, or EPIT , DBV Technologies method of delivering biologically active compounds to the

immune system through intact skin. With this new class of non-invasive product candidates, the Company is dedicated to safely transforming the care of food allergic patients. DBV Technologies food

allergies programs include ongoing clinical trials of Viaskin Peanut. DBV Technologies has global headquarters in Montrouge, France, and North American operations in Basking Ridge, NJ. The Company s ordinary shares are traded on segment B of

Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company s ADSs (each representing one-half of one ordinary share) are traded on the Nasdaq Global Select Market (Ticker: DBVT).

Forward-Looking Statements

This press release contains

forward-looking statements, including statements regarding DBV Technologies Viaskin Peanut, such as the regulatory pathway for approval by the FDA in children ages 1 to 3 years and the planned VITESSE Phase 3 clinical trial in older children

discussed in this press release. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. These forward-looking statements may be impacted by market conditions as well as other risks and

uncertainties set forth in DBV Technologies regulatory filings with the AMF, DBV Technologies filings and reports with the SEC, including in DBV Technologies Annual Report on Form 10-K for

the year ended December 31, 2021, filed with the SEC on March 9, 2022, and future filings and reports made with the AMF and SEC by DBV Technologies. Existing and prospective investors are cautioned not to place undue reliance on these

forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release.