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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 plans to change its American Depositary Shares (ADS) ratio from 1:1 to 1:5, effective around November 29, 2024. This change will function like a one-for-five reverse ADS split, aimed at regaining compliance with Nasdaq's minimum bid price requirement. ADS holders with certificated shares must surrender them for cancellation and will receive one new ADS for every five existing ones. Uncertificated ADS holders in DRS and DTC will have automatic exchanges. The company's ADSs will continue trading under 'DBVT' on Nasdaq. Fractional ADSs will be sold, with proceeds distributed to holders. The change won't affect underlying ordinary shares.
DBV Technologies reported Q3 2024 financial results with a cash balance of $46.4 million, down from $141.4 million at end of 2023. The company reported a net loss of $90.9 million for the first nine months of 2024, compared to $61.5 million in the same period of 2023. Operating expenses increased to $96.4 million, primarily due to research and development costs for the VITESSE Phase 3 clinical trial. The company's cash runway extends into Q1 2025, but there is substantial doubt about its ability to continue as a going concern without additional capital.
DBV Technologies (DBVT) announced positive regulatory updates for the Viaskin® Peanut patch in the US and Europe. The company will pursue an Accelerated Approval pathway for toddlers ages 1-3 years old, subject to completing a six-month supplemental safety study (COMFORT Toddlers) in Q2 2025. The VITESSE Phase 3 study for children ages 4-7 exceeded enrollment goals, with topline results expected in Q4 2025.
The European Medicines Agency (EMA) confirmed a registration path for a Marketing Authorization Application (MAA) with the modified Viaskin peanut patch for a 1-7 year-old indication in Europe. DBV plans to formalize the FDA guidance via a meeting request. The company's cash and cash equivalents amounted to $46.4 million as of September 30, 2024, with funding projected to last into Q1 2025.
DBV Technologies (Nasdaq: DBVT) announced its participation in the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting from October 24-28, 2024, in Boston. The company will feature a 'Product Theater' panel discussion on 'What Defines an Optimal Peanut Allergy Treatment?' on October 26th. DBV is also sponsoring the 33rd Annual FIT Bowl and will host a booth in the ACAAI Exhibit Hall.
Dr. Pharis Mohideen, Chief Medical Officer of DBV Technologies, highlighted the company's recent completion of enrollment for the VITESSE study in children 4-7 years old. DBV continues to advance regulatory progress with the Viaskin® peanut patch for 1-3-year-olds and 4-7-year-olds. The Viaskin Peanut patch is DBV's lead product candidate designed to reduce the risk of allergic reactions due to accidental peanut exposure through an investigational, non-invasive, once-daily epicutaneous patch.
DBV Technologies has released information regarding its total number of voting rights and shares as of September 30, 2024, in compliance with Article 223-16 of the General Regulations of the Autorité des Marchés Financiers. The company, listed on NYSE Euronext Paris with ISIN Code FR 0010417345, reported a total of 96,501,526 shares as of the specified date. The total gross voting rights also stood at 96,501,526, while the total net voting rights were 96,199,467. The net total is calculated by subtracting shares without voting rights from the total number of voting rights attached to shares.
DBV Technologies has completed screening for its VITESSE Phase 3 clinical trial, evaluating the Viaskin® Peanut Patch in peanut-allergic children ages 4-7 years old. The company exceeded its recruitment goal in Q3 2024, closing the screening process earlier than anticipated. The VITESSE trial is the largest immunotherapy clinical trial for this patient population, with over 600 subjects randomized 2:1 across 86 sites globally.
Dr. Pharis Mohideen, Chief Medical Officer, expressed gratitude towards study centers, subjects, and their families for their commitment. The trial aims to evaluate the efficacy and safety of the modified Viaskin Peanut Patch over 12 months. Topline results are expected by Q4 2025. DBV Technologies continues to focus on advancing this program to support a Biologic License Application submission.
DBV Technologies (Euronext: DBV, Nasdaq: DBVT), a clinical-stage biopharmaceutical company, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event is scheduled for Monday, September 9, 2024, in New York City. Daniel Tassé, the company's Chief Executive Officer, will engage in a fireside chat at 3:00 pm ET.
Investors and interested parties can access a live webcast of the presentation through a provided link or via the Events section of DBV Technologies' Investors website. For those unable to attend live, a replay will be available on the company's website for 90 days following the event, offering extended access to the presentation content.
DBV Technologies (DBVT) has released an update on its total number of voting rights and shares as of July 31, 2024. The company reported a total of 96,498,927 shares outstanding. The total gross voting rights also stand at 96,498,927, while the total net voting rights are 96,214,457. This information is provided in compliance with Article 223-16 of the General Regulations of the Autorité des Marchés Financiers. DBV Technologies is listed on the NYSE Euronext Paris under the ISIN Code FR 0010417345.
DBV Technologies (Euronext: DBV, Nasdaq: DBVT), a clinical-stage biopharmaceutical company focused on food allergies and immunologic conditions, has announced the filing of its 2024 Half-Year Report for the semester ended June 30, 2024. The report has been filed with the French market authority, Autorité des Marchés Financiers (AMF).
The 2024 Half-Year Report is now available for consultation or download in French on the company's website (www.dbv-technologies.com) under the Investors/Financial Information section, as well as on the AMF website (www.amf-france.org). Interested parties can also request a free copy by mail or email from DBV Technologies.
DBV Technologies (DBVT) provided updates on its Viaskin Peanut program and reported Q2 2024 financial results. Key highlights:
- VITESSE Phase 3 study enrollment for 4-7 year olds with peanut allergy is on track to complete by Q3 2024
- Submitted labeling proposal to FDA for COMFORT Toddlers study in 1-3 year olds
- Q2 2024 cash balance of $66.2 million, with runway extended into Q1 2025 due to cost-saving measures
- Q2 2024 net loss of $60.5 million or $0.63 per share
- Operating expenses increased to $65.0 million in H1 2024 vs $50.7 million in H1 2023, driven by R&D costs
The company faces substantial doubt about its ability to continue as a going concern beyond Q1 2025 without additional capital.
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