Dbv Technologies S A Stock Price, News & Analysis

DBV Technologies reported its Q1 2025 financial results, showing a decrease in cash position to $13.0 million as of March 31, 2025, down from $32.5 million at the end of 2024. The company's net loss was $27.1 million, or $(0.26) per share, slightly improved from $27.3 million in Q1 2024.

Key financial highlights include:

• Operating expenses decreased to $27.4 million from $30.0 million year-over-year
• Research & Development costs remained stable at $21.5 million
• Operating income declined to $0.8 million from $1.4 million

Notably, the company secured a significant financing of up to $306.9 million on March 27, 2025, with initial proceeds of $125.5 million received in April 2025. This funding is intended to advance the Viaskin Peanut Patch through BLA submission and potential U.S. commercial launch. The company projects its current cash position will fund operations into June 2026.

DBV Technologies (DBVT) has announced the filing of its 2024 Annual Report on Form 10-K with the SEC and Universal Registration Document (URD) with the French AMF. The company's audited financial statements for the year ended December 31, 2024, were approved by the Board of Directors on April 11, 2025, showing no changes from the unaudited statements published on March 24, 2025.

The 2024 URD includes the Annual Financial Report, Management Report, Corporate Governance Report, and Share Buyback Program description. Both documents are accessible through the company's website, with the URD available on AMF's website and Form 10-K on SEC's website. Free printed copies can be obtained at DBV's headquarters in Châtillon, France.

DBV Technologies (DBVT) has secured a financing package of up to $306.9 million to advance its Viaskin® peanut patch program. The funding includes $125.5 million upfront and potential additional $181.4 million from warrant exercises.

The financing will support the company through its expected Biologics License Application (BLA) submission to FDA for the Viaskin® peanut patch in children aged 4-7 years and potential commercial launch. The VITESSE Phase 3 study has enrolled 654 subjects, exceeding the target of 600, with results expected in Q4 2025.

Key investors include MPM BioImpact, Adage Capital Management, Janus Henderson Investors, and others. The financing will result in an immediate dilution of 22.4% and potential maximum dilution of 73.7% if all warrants are exercised. The funding extends DBV's financial visibility into 2028, supporting potential US commercialization if approved.

DBV Technologies (DBVT) has secured FDA agreement that safety exposure data from the VITESSE Phase 3 study will be sufficient for their Biologics License Application (BLA) for Viaskin® peanut patch in children aged 4-7 years with peanut allergy. This eliminates the need for the COMFORT Children supplemental safety study, accelerating the BLA submission timeline to first half of 2026.

The VITESSE study, the largest Phase 3 trial for peanut allergy in this age group with 654 participants, will provide safety data from over 500 participants on active treatment. Topline results are expected in Q4 2025.

The company reported unaudited 2024 financial results with cash and cash equivalents of $32.5 million as of December 31, 2024, down from $141.4 million year-over-year. Operating expenses increased to $120.7 million from $92.2 million in 2023. Net loss widened to $113.9 million ($1.17 per share). Current cash is only sufficient to fund operations into April 2025, raising substantial going concern doubts.

DBV Technologies (DBVT) announced its participation in the AAAAI/WAO Joint Congress from February 28-March 3, 2025, in San Diego. The company will present significant findings from the PEOPLE study, a long-term extension of the Phase 3 PEPITES trial evaluating VIASKIN® peanut patch in peanut-allergic children aged 4-11 years.

Key results at Month 60 show:

• Treatment responders increased to 73.3% (from 39.1% at PEPITES completion)
• 66.7% of participants achieved tolerance to ≥1000 mg peanut protein (equivalent to 3-4 peanut kernels)
• 33.3% reached tolerance to ≥2000 mg peanut protein (6-8 peanut kernels)
• 93.1% treatment compliance rate over five years

Most treatment-related adverse events were mild to moderate local skin reactions, decreasing in frequency over time. The company aims to complete regulatory submissions for two age groups: toddlers (1-3 years) and children (4-7 years).

DBV Technologies (DBVT) has released its Half-Year report on the liquidity contract with ODDO BHF. As of December 31, 2024, the liquidity account held 266,868 DBV Technologies shares and €106,930.51 in cash. This represents a significant change from the contract's implementation on July 1, 2018, which started with 41,159 shares and €432,367.25.

During the period from July 1, 2024, to December 31, 2024, trading activity included 1,682 buy transactions and 1,800 sales transactions. The total volume traded comprised 404,081 shares (€296,390.97) in purchases and 440,957 shares (€340,906.76) in sales.

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.