Dbv Technologies S A Stock Price, News & Analysis

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.

DBV Technologies has announced the initiation of its Phase 3 study, VITESSE, to assess the modified Viaskin Peanut Patch in peanut-allergic children aged 4 to 7 years. After productive discussions with the FDA, DBV expects to screen its first patient in Q4 2022 and anticipates topline results by Q1 2025. The study aims to enroll 600 participants and evaluates the efficacy and safety of the patch, which could support a future BLA submission. The FDA has approved the study following collaborative efforts on the trial design.

DBV Technologies (Euronext: DBV, Nasdaq: DBVT) announced that CEO Daniel Tassé will participate in two investor conferences this September. The first is the Wells Fargo Healthcare Conference from September 7-9, where he will engage in a fireside chat on September 8 at 4:20 p.m. ET in Boston. The second is the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, featuring a presentation by Tassé on September 12 at 11:00 a.m. ET in New York. Live webcasts will be available on the company's website, with replays to follow.

DBV Technologies reported its Q2 2022 financial results, revealing a cash balance of $248 million as of June 30, 2022, a significant increase from $77.3 million at year-end 2021. The company secured $195.3 million through an ATM offering and $181.2 million from a PIPE offering. Operating expenses decreased by 14% year-over-year to $25.4 million, while net loss narrowed to $23 million from $30.7 million in Q2 2021. DBV continues to engage with the FDA on its Phase 3 clinical study of the modified Viaskin™ Peanut patch.