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DBV Technologies S.A. (symbol: DBVT) is a clinical-stage specialty biopharmaceutical company revolutionizing the treatment of food allergies, a significant and growing public health issue. Founded in 2002, the company has developed a groundbreaking technology platform known as Viaskin®.
Viaskin® employs epicutaneous immunotherapy (EPIT), a proprietary method that administers allergens through an epicutaneous patch applied to intact skin. This innovative approach targets Langerhans cells, specialized immune cells in the skin, which capture the allergen and migrate to the lymph nodes. This mechanism allows for activation of the immune system without introducing the allergen into the bloodstream, thus minimizing systemic exposure and the risk of severe allergic reactions.
DBV Technologies' flagship product, Viaskin Peanut, is designed for peanut-allergic patients. The patch aims to improve patient tolerability to peanuts and significantly reduce the risk of life-threatening allergic reactions upon accidental exposure. Clinical trials have demonstrated the product's efficacy and safety, making it a promising solution for millions of individuals affected by peanut allergies.
In addition to peanut allergies, DBV Technologies is expanding its portfolio to address other food allergies like milk. The company's robust pipeline and innovative approach position it at the forefront of allergy treatment research.
DBV Technologies has secured multiple worldwide patents for its Viaskin® technology, underlining its pioneering role in the field of immunotherapy. The company continually collaborates with leading research institutions and partners to advance its clinical programs and bring new therapies to market.
Recent achievements include significant milestones in clinical trials, regulatory submissions, and strategic partnerships, reflecting DBV Technologies' commitment to developing safe and effective treatments for food allergies. The company's dedication to addressing unmet medical needs ensures it remains a crucial player in the biopharmaceutical landscape.
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.
DBV Technologies announced a $194 million private placement financing on June 9, 2022, aimed at strengthening its financial position. The deal involves selling 32,855,669 ordinary shares at €3.00 each and pre-funded warrants at €2.90, with total gross proceeds estimated at approximately $194 million before expenses. Major investors include Braidwell LP, Baker Bros. Advisors LP, and Venrock Healthcare Capital Partners, among others. The closing of the financing is anticipated on June 13, 2022, subject to customary conditions.
DBV Technologies announced positive topline results from its Phase 3 EPITOPE trial evaluating Viaskin Peanut for peanut-allergic toddlers aged 1 to 3 years. The trial met its primary endpoint, with 67% of subjects in the treatment group achieving significant response criteria after 12 months, compared to 33.5% in the placebo group. Safety results were consistent with prior studies in older children, showing high compliance and a low discontinuation rate due to adverse events. DBV aims to analyze data for regulatory pathways, addressing a critical unmet need in this age group.
DBVT reported its total shares and voting rights as of April 30, 2022. The total number of shares stood at 55,095,537, while the total gross voting rights were also 55,095,537. After accounting for shares without voting rights, the total net voting rights amounted to 54,920,329. This information is compliant with Article 223-16 of the General Regulations of the Autorité des Marchés Financiers.