DBV Technologies S.A. - DBVT STOCK NEWS

DBV Technologies announced the FDA has lifted the partial clinical hold on its VITESSE Phase 3 trial, evaluating the Viaskin Peanut patch in peanut-allergic children. Patient screening is expected to start in Q1 2023, with topline results anticipated in 1H 2025. The FDA requested modifications to the trial protocol to support a Biologics License Application, including changes in daily wear time and safety assessments. DBV stated it has sufficient cash to fund operations through VITESSE topline data.

DBVT has released its monthly information as of November 30, 2022, detailing the total number of voting rights and shares. The company reported a total of 94,137,145 shares, with 94,137,145 gross voting rights and 93,966,891 net voting rights after accounting for shares without voting rights. This update complies with Article 223-16 of the General Regulations of the Autorité des Marchés Financiers.

DBV Technologies (Euronext: DBV, Nasdaq: DBVT) announced its participation in the 5th Annual Evercore ISI HealthCONx Conference from Nov. 29 to Dec. 1, 2022. CEO Daniel Tassé will engage in a Fireside Chat on Nov. 30 at 8 a.m. ET and hold one-on-one investor meetings. A live webcast of the session will be available on the company's website, with a replay accessible for 90 days post-event. DBV Technologies focuses on developing Viaskin™, a non-invasive immunotherapy technology, targeting food allergies, particularly through its ongoing clinical trials of Viaskin Peanut.

DBV Technologies (DBVT) announced the presentation of new clinical data on Viaskin™ Peanut at the ACAAI Annual Scientific Meeting in Louisville, KY, from November 10-14, 2022. The data focuses on peanut-allergic toddlers aged 1-3 years, highlighting Viaskin Peanut's potential as a treatment option. Two abstracts have been accepted for presentation, including an oral presentation scheduled for November 12. The company aims to demonstrate the efficacy of its epicutaneous immunotherapy approach to peanut allergy prevention in young children, pending regulatory approval.

DBV Technologies reported its third quarter financial results on November 3, 2022, highlighting a cash balance of $213 million. The company achieved a 35% reduction in cash used in operating activities compared to the previous year, signaling effective budget measures. However, it faces a partial clinical hold on its VITESSE Phase 3 study, delaying initial patient screening past year-end 2022. Despite this, DBV experienced an increase in operating income to $6.1 million, driven by its collaboration with Nestlé Health Science. Net loss decreased to $57 million, or $0.79 per share.

DBV Technologies (DBVT) will announce its third quarter 2022 financial results on November 3, 2022, at 5:00 p.m. ET via a conference call and live audio webcast. Investors can access the call using specific teleconferencing numbers. DBV is focused on developing Viaskin™, an innovative technology for epicutaneous immunotherapy aimed at treating food allergies, particularly through their ongoing clinical trials for Viaskin Peanut. A replay of the event will be available on the company's website.

DBVT announced its monthly update concerning the total number of shares and voting rights as of September 30, 2022. The company has a total of 94,025,441 shares outstanding, with 93,888,340 voting rights net of shares without voting rights. This report adheres to Article 223-16 of the General Regulations of the Autorité des Marchés Financiers, underscoring transparency in shareholder communications.

DBV Technologies has announced the appointment of Timothy E. Morris as the new Chair of its Audit Committee, replacing Viviane Monges, who resigned on October 3, 2022. Morris, with extensive financial experience and a background as COO and CFO at Humanigen, has been on the board since April 2021. Additionally, Daniele Guyot-Caparros has been provisionally appointed as an Independent Director, pending shareholder ratification. Guyot-Caparros brings significant financial expertise from her past roles at PricewaterhouseCoopers and Rhône-Poulenc-Rorer, enhancing the board's composition.

DBV Technologies announced a partial clinical hold from the FDA on its VITESSE Phase 3 trial assessing the Viaskin Peanut immunotherapy in peanut-allergic children aged 4 to 7. The FDA’s feedback requires protocol modifications concerning statistical analysis, daily wear time, and participant numbers before moving forward. Currently, subject recruitment has not begun, but the hold does not impact other ongoing studies. DBV plans to provide updates after further discussions with the FDA.