DBVT - Earnings announcements

Châtillon, France, December 16, 2025 DBV Technologies Announces Positive Topline Results from Phase 3 VITESSE Trial of VIASKIN® Peanut Patch in Peanut Allergic Children Aged 4-7 Years VITESSE met its primary endpoint: the lower bound of the 95% confidence interval (CI) of the difference between treatment arms was 24.5%, exceeding the prespecified threshold of 15% 46.6% of children treated with the VIASKIN® Peanut patch met response criteria at 12 months, compared to 14.8% of children in the placebo arm Safety results were consistent with the safety profile observed in the VIASKIN Peanut clinical program to dateBLA submission in 4-7-year-olds on track for the first half of 2026Achievement

Châtillon, France, June 25, 2025 DBV Technologies Announces First Subject Screened in COMFORT Toddlers Supplemental Safety Study in Peanut Allergic Toddlers 1 – 3 Years Old First subject screened at the Respiratory Medicine Research Institute of Michigan with Dr. Jeffrey Leflein acting as Principal InvestigatorAdditional sites, including Allergy and Asthma Center of Minnesota and Hamilton Allergy and Immunology Clinic of Ontario, Canada have been activated and are scheduling screenings DBV Technologies (TRQX:DBVp), a clinical-stage biopharmaceutical company, today provided an update on the progress on the Company's COMFORT Toddlers supplemental safety study using the Viaskin® Peanut patc

Châtillon, France, January 8th, 2025 DBV Technologies Announces Positive 3-Year Results from EPITOPE Phase 3 Open-Label Extension Study EPITOPE OLE data demonstrates continued improvement in treatment benefit of VIASKIN® Peanut patch in toddlers 1 – 3 years through 36 months 68.2% of subjects completed the oral food challenge (~12-14 peanut kernels) without meeting stopping criteria, compared to 30.7% at month 12No treatment-related anaphylaxis or serious treatment-related Treatment-Emergent Adverse Events (TEAEs) occurred in year three of EPITOPE OLE    DBV also announced daily patch wear time data from EPITOPE that is supportive of the Company's proposed labeling approach shared with FD

Châtillon, France, December 11th, 2024 DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old DBV and FDA aligned on key study design elements for the COMFORT Toddlers study in 1 – 3 year-olds, including study size and wear time collection methodology and analysis COMFORT Toddlers study on-track to initiate in 2Q 2025Viaskin Peanut patch BLA submission for the Toddlers indication anticipated for 2H 2026 FDA confirmed criteria for post-marketing confirmatory study in toddlers 1 – 3 years-oldCompany to host investor webcast today at 5:00pm ET DBV Technologies (TRQX:DBVp), a clinical-stage biopharmaceutical company, tod

Châtillon, France, October 22, 2024 DBV Announces Positive Regulatory Updates for the Viaskin® Peanut Patch in the United States and Europe DBV to pursue an Accelerated Approval pathway for toddlers ages 1 – 3 years-old BLA submission under Accelerated Approval is subject to completion of a six-month supplemental safety study in toddlers to be initiated in Q2 2025VITESSE Phase 3 study evaluating the Viaskin Peanut patch in children ages 4 – 7 years-old exceeded enrollment goals; Topline results on track for 4Q 2025  European Medicines Agency (EMA) scientific advice confirms registration path for a Marketing Authorization Application (MAA) with the modified Viaskin peanut patch for a 1 – 7

Châtillon, France, July 30, 2024 DBV Technologies Provides Updates on the Viaskin Peanut Program in Children and Toddlers and Reports Second Quarter and Half-Year 2024 Financial Results VITESSE enrollment in peanut allergic 4-7-year-olds is on-track and recruitment is expected to be complete by end of Q3 2024 DBV submitted a labeling proposal, informed by the EPITOPE efficacy data, to the Food and Drug Administration (FDA) to address the FDA's protocol queries regarding patch wear-time in COMFORT ToddlersDBV closes Q2 2024 with a cash balance of $66.2 million; due to cost-saving measures, the Company's cash runway is extended into Q1 2025 DBV Technologies (Euronext: DBV – ISIN: FR0010417

Châtillon, France, July 29, 2024 DBV Technologies to Report Second Quarter 2024 Financial Results and Business Update on July 30, 2024 DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced that the Company will host a conference call and live audio webcast on Tuesday, July 30th, at 5:30 p.m. ET to review its second quarter 2024 financial results and provide a business update. Interested participants may access this call via the below teleconferencing numbers and asking to join the DBV Technologies call: United States: +1-877-346-6112International: +1-848-280-6350 A live webcast of the call will be a

Montrouge, France, March 7, 2024 DBV Technologies Reports Full Year 2023 Financial Results and Business Update Advanced Viaskin™ Peanut clinical development programs in peanut-allergic toddlers (1 through 3 years old) and children (4 through 7 years old)Strengthened executive leadership team in preparation for BLA submissionReported cash and cash equivalents of $141 million DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company focused on treatment options for food allergies and other immunologic conditions with significant unmet medical need, today reported financial results for the full year 2023. The audit procedure

Montrouge, France, March 4, 2024 DBV Technologies to Report Full Year 2023 Financial Results and Business Update on March 7, 2024 DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company focused on treatments for food allergies, today announced the Company will host a conference call and live audio webcast on Thursday, March 7th, at 5:00 p.m. ET to review full year 2023 financial results and provide a business update. Interested participants may access this call via the below teleconferencing numbers and reference the DBV Technologies call: United States: 1-844-481-2866International: 1-412-317-1859 A live webcast of th

Montrouge, France, November 9, 2023 DBV Technologies Announces 2-Year Results from Ongoing Phase 3 Open-Label Extension to the EPITOPE Trial (EPOPEX) of Viaskin™ Peanut in Toddlers Viaskin Peanut showed improvement between months 12 and 24 of treatment across all efficacy parameters. Notably, 81.3% of subjects who completed the oral food challenge reached an eliciting dose of ≥1,000 mg after 24 months of treatment.55.9% of subjects completed the oral food challenge at a cumulative dose of 3,444 mg without meeting stopping criteria.Among treatment-arm subjects from EPITOPE, there were no treatment-related anaphylactic or serious treatment-related adverse events in the second year of active

Montrouge, France, October 31, 2023 DBV Technologies Receives Requested Feedback from FDA on Protocol Design Elements for COMFORT Safety Studies and Reports Third Quarter 2023 Financial Results DBV has received written feedback from the U.S. Food and Drug Administration (FDA) clarifying design elements for both the COMFORT Toddlers and COMFORT Children supplemental safety studies.Both supplemental safety studies will have harmonized, simplified protocol language on how the product should be used.  The COMFORT Toddlers study will apply the same eligibility criteria as EPITOPE, DBV's successful Phase 3 efficacy study in toddlers 1-3 years.DBV will submit the final protocol for COMFORT Toddl

Montrouge, France, October 27, 2023 DBV Technologies to Report Third Quarter 2023 Financial Results and Business Update DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced that the Company will host a conference call and live audio webcast on Tuesday, October 31st, at 5:00 p.m. ET to review third quarter 2023 financial results and provide a business update. Interested participants may access this call via the below teleconferencing numbers and asking to join the DBV Technologies call: United States: 1-844-481-2866International: 1-412-317-1859 A live webcast of the call will be available on the In

Montrouge, France, July 31, 2023 DBV Technologies Receives Feedback from FDA on Design Elements for Viaskin Peanut Safety Studies and Reports Second Quarter and Half-Year 2023 Financial Results Received feedback from U.S. Food and Drug Administration (FDA) on DBV's two supplemental safety studies in toddlers (ages 1 – 3 years) and children (ages 4 – 7 years).The two Phase 3 pivotal safety studies will be named COMFORT Toddlers (1 – 3 years) and COMFORT Children (4 – 7 years).COMFORT Toddlers will be a 6-month safety study, consistent with agreement previously reached with FDA on the COMFORT Children safety study.The Company expects to seek final alignment with FDA on the COMFORT protocols

Montrouge, France, July 25, 2023 DBV Technologies to Report First Half 2023 Financial Results and Provide a Corporate Update DBV Technologies (GREY:DBVTF), a clinical-stage biopharmaceutical company, today announced that the Company will host a conference call and live audio webcast on Monday, July 31st, at 5:00 p.m. ET to report first half 2023 financial results and provide a corporate update. Participants may access this event via the below teleconferencing numbers and asking to join the DBV Technologies call: United States:         1-844-481-2866 International:         +1-412-317-1859                                                 A live webcast of the call will be availab

Montrouge, France, April 19, 2023 DBV Technologies Outlines Regulatory Path for Viaskin Peanut in Children 1 – 3 Years After Receiving Pre-BLA Responses from FDA The FDA confirmed that the Company's Phase 3 EPITOPE study met the pre-specified criteria for success for the primary endpoint and did not request an additional efficacy study. Additional safety data will be required to augment the safety data collected from EPITOPE in support of a BLA.The new safety study will also generate patch adhesion data and include updated Instructions for Use (IFU).Company reports cash and cash equivalents of $192.3 million as of March 31, 2023 based on preliminary and unaudited information.Company to hos

Montrouge, France, March 2, 2023 DBV Technologies Reports Full Year 2022 Financial Results and Business Update DBV completed EVOLVE, a 12-week caregiver and patient user experience study of the modified Viaskin Peanut patch in peanut-allergic children ages 4 – 11 years oldDBV had $209.2 million in Cash and Cash Equivalents at December 31, 2022. DBV Technologies (GREY:DBVTF), a clinical-stage biopharmaceutical company, today reported financial results for the full year 2022. The audit procedures have been substantially completed by the Company's statutory auditors and financials – prepared under both US GAAP and IFRS for the purpose of Form 10-K and Universal Registration Document respecti

Montrouge, France, February 27, 2023 DBV Technologies to Report Full Year 2022 Financial Results and Business Updates on March 2, 2023 DBV Technologies (GREY:DBVTF), a clinical-stage biopharmaceutical company, today announced that the Company will host a conference call and live audio webcast on Thursday, March 2, at 5:00 p.m. ET to report full year 2022 financial results and provide a business update. Interested participants may access this call via the below teleconferencing numbers and asking to join the DBV Technologies call: United States: 1-866-777-2509International: 1-412-317-5413 A live webcast of the call will be available on the Investors & Media section of the Company's webs

Montrouge, France, November 3, 2022 DBV Technologies Reports Third Quarter Financial Results and Business Update DBV closes Q3 with a cash balance of $213MDBV continues to practice budget discipline measures; cash used in operating activities decreased more than 35% between the nine months ended September 30, 2021, and 2022DBV continues to engage with the U.S. Food and Drug Administration (FDA) regarding the partial clinical hold on the VITESSE Phase 3 clinical study DBV Technologies (GREY:DBVTF), a clinical-stage biopharmaceutical company, today reported financial results for the third quarter of 2022. The quarterly financial statements were approved by the Board of Directors on November

Montrouge, France, October 31, 2022 DBV Technologies to Report Third Quarter 2022 Financial Results and Provide a Business Update DBV Technologies (GREY:DBVTF), a clinical-stage biopharmaceutical company, today announced that the Company will host a conference call and live audio webcast on Thursday, November 3, at 5:00 p.m. ET to report third quarter 2022 financial results and provide a corporate update. This call is accessible via the below teleconferencing numbers, followed by the reference ID: 94309191#. United States: 866 374 5140                                                Canada: 866 455 3403United Kingdom: 808 238 9813                                                France:

Montrouge, France, September 7, 2022 DBV Technologies Announces Initiation of Phase 3 Study (VITESSE) Using the Modified Viaskin Peanut Patch in Peanut -Allergic Children Ages 4 to 7 Years DBV has finalized the VITESSE protocol after productive exchanges with the U.S. Food and Drug Administration (FDA) concerning key study design elementsDBV expects to screen the first patient in Q4 2022 and anticipates topline results for the VITESSE study to read out in Q1 2025The VITESSE protocol has been submitted to study sites for subsequent Institutional Review Board (IRB)/Ethics Committee (EC) approval The Company will host a conference call at 5:30 p.m. ET (11:30 p.m. CEST) on Wednesday, Septembe

Montrouge, France, June 7, 2022 DBV Technologies Announces Positive Topline Results from Phase 3 EPITOPE Trial of Viaskin Peanut in Peanut-Allergic Toddlers 67.0% of subjects treated with Viaskin Peanut 250 µg met response criteria at 12 months, compared with 33.5% of subjects in the placebo armPivotal trial met primary endpoint: lower bound of the 95% confidence interval (CI) of the difference between treatment arms was 22.4%, exceeding the pre-specified threshold of 15%Safety results were generally consistent with safety profile of Viaskin Peanut 250 μg observed in children with peanut allergy ages 4 years and older in prior clinical trialsHigh treatment compliance rate observed over tri

Montrouge, France, April 25, 2022DBV Technologies to Report First Quarter 2022 Financial Results and Recent Business Developments DBV Technologies (GREY:DBVTF), a clinical-stage biopharmaceutical company, today announced that the Company will host a conference call and live audio webcast on Thursday, May 2, 2022, at 5:00 p.m. ET to report first quarter 2022 financial results and provide a corporate update. This call is accessible via the below teleconferencing numbers, followed by the reference ID: 89119188. United States: 866 374 5140                                             Canada: 866 455 3403United Kingdom: 808 238 9813                                                France

Montrouge, France, February 24, 2022 DBV Technologies to Report Full Year 2021 Financial Results and Business Updates on March 3, 2022 DBV Technologies (GREY:DBVTF), a clinical-stage biopharmaceutical company, today announced that the Company will host a conference call and live audio webcast on Thursday, March 3, 2022 at 5:00 p.m. ET to report full year 2021 financial results and provide a corporate update. This call is accessible via the below teleconferencing numbers, followed by the reference ID: 50283860.United States: (866) 939-3921                                                Canada: (866) 215-5508United Kingdom: 0808 238 9578                                        France: 080

Montrouge, France, December 20, 2021 DBV Technologies Provides Update on Investigational Viaskin™ Peanut DBV Technologies S.A. (GREY:DBVTF), a clinical-stage biopharmaceutical company, today announced plans to initiate a new, pivotal Phase 3 clinical study for a modified Viaskin™ Peanut patch in children in the intended patient population. The Company also issued an update on the Marketing Authorization Application for Viaskin Peanut with the European Medicines Agency (EMA). U.S. Regulatory Update: DBV has informed the U.S. Food and Drug Administration (FDA) of its intent to initiate a pivotal Phase 3 clinical study for a modified Viaskin Peanut patch in children in the intended pati

Montrouge, France, July 26, 2021 DBV Technologies to Report First Half 2021 Financial Results and Business Updates on August 2, 2021 DBV Technologies (GREY:DBVTF), a clinical-stage biopharmaceutical company, today announced that the Company will host a conference call and live audio webcast on Monday, August 2, 2021, at 5:00 p.m. ET to report first half 2021 financial results and provide a corporate update. This call is accessible via the below teleconferencing numbers, followed by the reference ID: 50184237.United States: (866)-939-3921                                                Canada: (866)-215-5508United Kingdom: 0808 238 9578                                        France: 0