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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 announced leadership changes with Dr. Hugh Sampson stepping down as Chief Scientific Officer effective December 1, 2020. He will transition to a role as Scientific Adviser to the CEO, remaining involved with the development of the epicutaneous immunotherapy platform. Dr. Sampson, who has been influential in advancing food allergy treatments, believes this change allows him to refocus on his research at Mount Sinai. DBV’s commitment to the Viaskin technology remains strong as they continue clinical trials aimed at food allergies.
Company Update: As of October 31, 2020, the total number of shares for the Company is 54,927,187, with a total number of voting rights amounting to 54,927,187 (gross) and 54,786,929 (net). This data reflects compliance with the Autorité des Marchés Financiers regulations.
Market: NYSE Euronext Paris | ISIN Code: FR 0010417345
DBV Technologies will present new data on its Viaskin™ Peanut treatment at the ACAAI Annual Scientific Meeting from Nov. 13-15, 2020. Key highlights include four accepted abstracts, with one oral presentation and three poster presentations, detailing the treatment's patient experience, patch adhesion, and prediction of desensitization to peanuts. The event will also feature a symposium on managing food allergies during the COVID-19 pandemic. DBV's ongoing commitment to innovative treatments aims to ease the burden of peanut allergies for patients and families.
DBV Technologies announced its participation in several upcoming virtual investor conferences. CEO Daniel Tassé will host fireside chats at the following:
- Credit Suisse Healthcare Conference: November 11, 2020, at 12:30 PM ET
- Stifel Healthcare Conference: November 16, 2020, at 8:00 AM ET
- Evercore HealthconX: December 1, 2020, at 12:35 PM ET
Webcasts will be available on the company’s website, with replays posted afterward. DBV focuses on developing Viaskin™, an innovative immunotherapy platform for food allergies.
DBV Technologies has announced the validation of its Marketing Authorization Application (MAA) for Viaskin™ Peanut by the European Medicines Agency (EMA). This investigational product aims to treat peanut allergies in children aged 4 to 11 through a non-invasive, daily epicutaneous patch. The EMA will now conduct a review, with an initial set of questions expected within 120 days. This follows a Complete Response Letter from the FDA regarding its Biologics License Application. DBV is engaging the FDA to discuss future regulatory pathways.
DBV Technologies reported a cash position of €189.1 million as of September 30, 2020, down from €225.9 million in June. The company noted a decrease in average monthly cash burn during Q3 2020, with expectations for further reduction through 2021, driven by an ongoing global restructuring plan. DBV anticipates a 40-50% reduction in cash burn compared to the first half of 2020. As of September 30, 2020, there were 54,927,187 outstanding shares and 57,687,615 on a fully diluted basis. The company aims to extend its cash runway to the second half of 2022 to continue developing its Viaskin™ Peanut treatment.
As of September 30, 2020, the company reported a total of 54,927,187 shares outstanding, with a total number of voting rights amounting to 54,927,187 gross and 54,819,687 net. This data is in compliance with Article 223-16 of the General Regulations of the Autorité des Marchés Financiers. The information is essential for shareholders and potential investors.
The press release provides key information on the total number of shares and voting rights of the Company as of August 31, 2020. As per the report, the total number of shares stands at 54,927,187, while the total gross voting rights amount to 54,927,187. The total net voting rights, after accounting for shares without voting rights, is 54,844,056. This information is in compliance with Article 223-16 of the General Regulations of the Autorité des Marchés Financiers.
DBV Technologies has announced major leadership changes effective October 2, 2020. CFO Ramzi Benamar and CCO Kevin Trapp will depart, while Sébastien Robitaille will assume the CFO role. Robitaille, with a tenure at DBV since 2015, brings extensive experience through various leadership positions, including Chief Transformation Officer. The company expresses gratitude for the outgoing executives' contributions, highlighting Benamar's role in strengthening the balance sheet and Trapp's development of a commercial strategy for Viaskin Peanut. DBV also noted a recent FDA Complete Response Letter regarding its Biologics License Application.
DBV Technologies, a clinical-stage biopharmaceutical company, announced participation in several investor conferences in September 2020, including:
- Citi’s 15th Annual BioPharma Virtual Conference on September 9-10.
- Goldman Sachs 10th Annual Biotech Symposium on September 11.
- H. C. Wainwright 22nd Annual Global Investment Conference from September 14-16, featuring a fireside chat by CEO Daniel Tassé on September 15 at 10:00 AM ET.
- Morgan Stanley 18th Annual Global Healthcare Conference from September 14-18, with Daniel Tassé speaking on September 16 at 8:45 AM ET.
Webcasts of these events will be available on DBV's website.