DBV Technologies S.A. - DBVT STOCK NEWS

DBV Technologies (DBVT) has announced positive three-year results from the EPITOPE Phase 3 Open-Label Extension Study for its VIASKIN® Peanut patch treatment in toddlers aged 1-3 years. After 36 months of treatment, 83.5% of participants reached an eliciting dose of ≥1000 mg, up from 64.2% at month 12. 68.2% of subjects completed the oral food challenge without meeting stopping criteria, compared to 30.7% at month 12.

The study showed continued improvement in efficacy with no treatment-related anaphylaxis or serious treatment-related adverse events in year three. New data analysis revealed that subjects with average daily wear time (ADWT) ≥20 hours showed better efficacy response (75.7%) compared to those with <20 hours (47.3%). The company also reported that 68.4% of participants maintained an ADWT ≥20 hours, demonstrating strong correlation between wear time and treatment effectiveness.

DBV Technologies has secured FDA alignment on an Accelerated Approval pathway for the Viaskin® Peanut patch in toddlers aged 1-3 years. The FDA confirmed that efficacy data from the Phase 3 EPITOPE study can serve as an intermediate clinical endpoint for approval. The company plans to initiate the COMFORT Toddlers study in Q2 2025, enrolling approximately 480 subjects across multiple countries.

The COMFORT Toddlers study will be a six-month double-blind, placebo-controlled trial followed by an optional 18-month open-label treatment phase. DBV anticipates submitting a Biologics License Application (BLA) for the toddler indication in the second half of 2026. The FDA has also agreed on criteria for a post-marketing confirmatory study, which will need to be initiated at the time of BLA submission.

DBV Technologies has reported its voting rights and share count as of November 30, 2024. The company's total number of shares stands at 102,847,501. The gross voting rights total 102,847,501, while the net voting rights amount to 102,582,335. The difference between gross and net voting rights (265,166) represents shares without voting rights. The company's shares are listed on NYSE Euronext Paris under the ISIN Code FR 0010417345.

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.