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DBV Technologies S.A. develops treatment options for food allergies and other immunologic conditions as a late-stage biopharmaceutical company. Company updates center on the proprietary VIASKIN® patch technology, epicutaneous immunotherapy, and the VIASKIN Peanut program for peanut-allergic toddlers and children.
Recurring developments include clinical data from the Phase 3 VITESSE study, annual and quarterly financial results, financing and warrant-related capital actions, leadership and governance changes, share and voting-rights disclosures under French market rules, and market information tied to DBVT American Depositary Shares.
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.
DBV Technologies has released its Half-Year Report for the liquidity contract with ODDO BHF, detailing financial transactions and asset management as of June 30, 2022. The liquidity account holds 106,287 shares valued at €430,854.35. Since the contract's inception in July 2018, resources have slightly decreased from 41,159 shares and €432,367.25 initially. In the first half of 2022, 706 purchases and 869 sales were made, with total volumes of €1,056,560.18 for purchases and €1,311,871.05 for sales.
DBVT announced the total number of shares and voting rights as of June 30, 2022. The company has 94,022,679 shares and 94,022,679 voting rights in total, with a net of 92,916,392 voting rights after accounting for shares without voting rights. This information complies with Article 223-16 of the General Regulations of the Autorité des Marchés Financiers.
The stock is traded on the NYSE Euronext Paris under ISIN code FR 0010417345.
DBV Technologies announced its participation in the EAACI 2022 Congress from July 1-3 in Prague, Czech Republic. The company will present key data on the economic burden of peanut allergies in children aged 4-11 in Europe and showcase a novel Basophil Activation Test (BAT) to predict peanut challenge outcomes. Additionally, DBV will host a symposium on food allergies and exhibit its Viaskin™ technology, aimed at treating peanut allergies. This innovative approach aims to reduce allergic reactions in peanut-allergic children.
DBV Technologies, a clinical-stage biopharmaceutical company, will present at the JMP Securities Life Sciences Conference in New York on June 16, 2022, at 12:00 p.m. ET. CEO Daniel Tassé and CMO Dr. Pharis Mohideen will participate in a fireside chat. Investors can access a live webcast of the event on the company's website, with a replay available afterward. DBV Technologies is focused on developing Viaskin™, an innovative platform for non-invasive immunotherapy targeting food allergies, including ongoing trials for Viaskin Peanut.