DBV Technologies S.A. (DBVT) Bundle
How does a clinical-stage biopharmaceutical company, still in the red with a net loss of $102.1 million for the first nine months of 2025, command the market's attention? DBV Technologies S.A. (DBVT) is that company, holding a pivotal position in the allergy treatment space by pioneering epicutaneous immunotherapy (EPIT) with its non-invasive Viaskin platform. With the last patient visit in the VITESSE Phase 3 trial for the Viaskin Peanut patch completed in November 2025, the market is on a knife's edge, waiting for topline data that could validate their core technology and turn $2.77 million in Q3 2025 revenue into a commercial blockbuster. You need to understand the mechanics of this high-stakes, development-stage business, defintely before the next regulatory milestone hits.
DBV Technologies S.A. (DBVT) History
You're looking for the foundational story of DBV Technologies S.A., the French biopharmaceutical company pioneering a non-invasive treatment for food allergies. The direct takeaway is that DBV Technologies S.A. was born from a clinical need identified by pediatric specialists, and its trajectory has been a volatile, capital-intensive pursuit of regulatory approval for its core Viaskin technology, culminating in a critical $306.9 million financing round in early 2025 to push for a U.S. launch.
DBV Technologies S.A. Founding Timeline
Year established
The company was established in 2002, a time when few non-invasive, disease-modifying treatments for food allergies existed.
Original location
DBV Technologies S.A. was originally located in Bagneux, France, before moving its global headquarters to Châtillon, France, and establishing North American operations in Warren, NJ.
Founding team members
The company was founded by a team of medical and engineering experts who sought a better way to diagnose and treat allergies:
- Dr. Pierre-Henri Benhamou (Pediatric Gastroenterologist)
- Engineer Bertrand Dupont
- Professor Christophe Dupont (Head of Neonatology Department)
Initial capital/funding
The founders initially provided startup capital, which was quickly followed by significant venture funding. Between December 2003 and January 2011, the company acquired approximately €40 million in venture funding.
Here's the quick math: that early venture capital, plus a subsequent initial public offering (IPO) on the NYSE Euronext in March 2012 that yielded another €40.5 million, set the stage for years of clinical development.
DBV Technologies S.A. Evolution Milestones
| Year | Key Event | Significance |
|---|---|---|
| 2006 | First clinical trial using EPIT® (Epicutaneous Immunotherapy) | Validated the feasibility and safety of the Viaskin patch technology in treating milk allergy. |
| 2014 | Positive results from the VIPES Phase 2b trial of Viaskin Peanut | Demonstrated a statistically significant desensitization effect in peanut-allergic children, fueling optimism for a path to market. |
| 2020 | U.S. FDA issues a Refusal to File (RTF) letter for Viaskin Peanut BLA | A major setback; the FDA found the Biologic License Application incomplete, requiring new data and a significant shift in the regulatory strategy. |
| March 2025 | Secured up to $306.9 million in new financing | A critical lifeline and vote of confidence from investors to fund the final clinical trials and prepare for a potential U.S. commercial launch. |
| November 2025 | Last Patient Visit Completed in VITESSE Phase 3 clinical trial | Marks the completion of the treatment phase for the pivotal trial of Viaskin Peanut in children aged 4-7 years, moving closer to a new Biologics License Application (BLA) submission. |
DBV Technologies S.A. Transformative Moments
The company's journey is a classic biotech story of high-risk, high-reward, punctuated by regulatory hurdles and massive capital raises. The core transformative moment centers on the FDA's 2020 Refusal to File (RTF) for Viaskin Peanut.
That RTF forced a complete strategic reset, shifting the focus from a quick market entry to a more rigorous, multi-trial approach to satisfy the FDA. This meant a substantial capital burn, but also a defintely stronger clinical package.
The most recent transformative event is the March 2025 financing. The deal, which could total up to $306.9 million, provided the necessary runway to execute on the new regulatory strategy, including the COMFORT and VITESSE studies.
This financing was essential because, as of June 30, 2025, the company's net loss for the first half of the year was $69.0 million, underscoring the high cost of late-stage clinical development. The cash infusion boosted their cash and cash equivalents to $103.2 million as of that date, compared to $32.5 million at the end of 2024.
The focus is now clearly on the Viaskin Peanut program for toddlers and children, with the recent completion of the VITESSE Phase 3 last patient visit in November 2025. This sets up the next 12-18 months for data analysis and a potential BLA resubmission, which will be the ultimate test of the company's evolution. If you want to dive deeper into the financial mechanics of this high-stakes period, you should read Breaking Down DBV Technologies S.A. (DBVT) Financial Health: Key Insights for Investors.
DBV Technologies S.A. (DBVT) Ownership Structure
DBV Technologies S.A. is a publicly traded, clinical-stage biopharmaceutical company, and its ownership structure is heavily weighted toward institutional investors, a common dynamic in the biotech world where specialized funds drive capital. This concentration of institutional holdings means a few large players exert significant influence over strategic decisions, especially regarding its core product, the Viaskin® Peanut patch.
DBV Technologies S.A. Current Status
DBV Technologies S.A. (DBVT) operates as a public company, dual-listed on the Nasdaq Stock Market (DBVT) in the United States and Euronext Paris (DBV) in France. As of November 14, 2025, the company maintained a market capitalization of approximately $455.51 million, with its stock trading at $13.24 per share. This dual listing provides access to both European and US capital markets, which is crucial for funding the high-cost, long-term clinical trials required for its drug development pipeline. The company is currently focused on its Biologics License Application (BLA) path for Viaskin® Peanut, with topline results from the Phase 3 VITESSE trial expected in the fourth quarter of 2025.
DBV Technologies S.A. Ownership Breakdown
The company's ownership profile is dominated by institutional money, reflecting the high-risk, high-reward nature of clinical-stage biopharma investing. Here's the quick math on who controls the shares, based on the latest available data for the 2025 fiscal year. With institutional ownership nearing three-quarters of the company, retail investors have a smaller, though still important, voice.
| Shareholder Type | Ownership, % | Notes |
|---|---|---|
| Institutional Investors | 71.74% | Includes major biotech specialists like Baker Bros. Advisors Lp and Vivo Capital, LLC, who hold significant stakes. |
| Retail/Public Investors | 28.20% | The remaining float held by individual investors and non-reporting entities. |
| Insiders (Executives/Directors) | 0.06% | A very small percentage, suggesting executive compensation is less tied to direct equity ownership than to performance-based awards. |
For a deeper dive into the company's financial stability, you should check out Breaking Down DBV Technologies S.A. (DBVT) Financial Health: Key Insights for Investors.
DBV Technologies S.A. Leadership
The executive team steering DBV Technologies S.A. is a mix of seasoned biopharma veterans, with a recent focus on commercial readiness as the company anticipates key clinical trial results. The average tenure for the management team is relatively short, which can signal a fresh, aggressive push toward commercialization, but also a defintely higher risk of execution issues.
- Daniel Tassé: Chief Executive Officer.
- Michel de Rosen: Chairman of the Board of Directors.
- Virginie Boucinha: Chief Financial Officer, managing the cash runway which was estimated to last into the third quarter of 2026 as of September 30, 2025.
- Kevin Trapp: Chief Commercial Officer, appointed on November 3, 2025, specifically to lead the global commercial strategy for the Viaskin® Peanut patch.
- Pharis Mohideen: Chief Medical Officer, overseeing the clinical development pipeline.
- Robert Pietrusko, PharmD: Chief Regulatory Officer, critical for navigating the FDA's Biologics License Application (BLA) process.
The immediate action item for you is to monitor the Q4 2025 VITESSE Phase 3 topline results, as this data will be the primary driver of the stock price and the leadership's near-term strategy.
DBV Technologies S.A. (DBVT) Mission and Values
DBV Technologies S.A. is fundamentally driven by a singular purpose: transforming the lives of patients suffering from food allergies through non-invasive, epicutaneous immunotherapy (EPIT). This mission is backed by significant financial commitment, including securing up to $306.9 million in financing during the first half of 2025 to advance their lead product, Viaskin® Peanut.
DBV Technologies S.A.'s Core Purpose
You're looking at a biopharmaceutical company whose core purpose goes beyond just selling a product; it's about pioneering a new class of treatment. Their operational framework, centered on the Viaskin® patch, is designed to safely re-educate the immune system, which is a massive, unmet need in medicine. Honestly, that's a powerful driver for long-term value creation.
Official mission statement
While a single, formal mission statement is often inferred from their public communications, the consistent message is a commitment to patient-centric innovation. This commitment defines their research and development (R&D) focus, which is where the real money and effort go. Here's the quick math on their focus:
- Pioneering epicutaneous immunotherapy (EPIT), a non-invasive treatment method.
- Developing safe and effective solutions for food allergies and other immunological diseases.
- Advancing the Viaskin® Peanut program toward a Biologics License Application (BLA) submission.
This dedication to scientific rigor is why the company had cash and cash equivalents of $103.2 million as of June 30, 2025, specifically earmarked to fund continued development and potential U.S. launch readiness.
Vision statement
The long-term vision for DBV Technologies S.A. is simple and platform-focused: realize the full potential of the Viaskin™ Platform. This isn't just about peanut allergy; it's about expanding the technology to a new class of immunotherapy to help people with other significant unmet medical needs.
A successful platform vision means the initial R&D investment-like the massive financing raised in 2025-can be leveraged across multiple indications. They are defintely looking past the immediate product to a wider range of applications, including other immunological disorders and even non-invasive vaccine delivery. You can read more about this vision here: Mission Statement, Vision, & Core Values of DBV Technologies S.A. (DBVT).
DBV Technologies S.A. slogan/tagline
The company doesn't use a catchy, consumer-facing slogan, but their core commitment acts as their de facto tagline in all investor and medical communications. It's a clear, actionable statement that guides every decision, from clinical trial design to financing strategy:
- Committed to transforming the care of food allergic people.
This focus on transforming care, not just treating symptoms, is what differentiates them in the competitive biopharmaceutical space. It's a high-risk, high-reward strategy, but the potential patient impact is immense.
DBV Technologies S.A. (DBVT) How It Works
DBV Technologies operates as a clinical-stage biopharmaceutical company focused on developing a new class of immunotherapy to treat food allergies and other immunological conditions. The company's value creation hinges on its proprietary Viaskin platform, which uses a simple patch to deliver microgram doses of allergen protein to the intact skin, a process called Epicutaneous Immunotherapy (EPIT), aiming to desensitize the patient without the risks associated with oral or injectable methods.
The entire business model is currently centered on advancing these product candidates through rigorous clinical trials and securing regulatory approval, which is why the company reported a net loss of $102.1 million for the nine months ended September 30, 2025, reflecting heavy investment in R&D.
DBV Technologies' Product/Service Portfolio
The company's portfolio is a pipeline of potential treatments built entirely on the Viaskin platform, with the lead candidate nearing a critical data readout in late 2025.
| Product/Service | Target Market | Key Features |
|---|---|---|
| Viaskin Peanut (Lead Candidate) | Peanut-allergic children aged 4-7 years (VITESSE trial) | Non-invasive, daily patch; delivers peanut protein to intact skin; topline Phase 3 data expected in Q4 2025. |
| Viaskin Peanut (Toddler Indication) | Peanut-allergic toddlers aged 1-3 years | Accelerated Approval Pathway agreed with U.S. FDA; BLA submission anticipated for the second half of 2026. |
| Viaskin Milk | Patients with IgE-mediated Cow's Milk Protein Allergy (CMPA) | Next-generation Viaskin patch; currently in Phase 1/2 clinical trial for safety and efficacy. |
DBV Technologies' Operational Framework
The operational framework is essentially a high-stakes clinical development machine, built to shepherd the Viaskin platform through complex regulatory hurdles and into commercial readiness.
- R&D Focus: The primary operational activity is managing global clinical trials, like the VITESSE Phase 3 trial, which enrolled 654 children across 86 sites internationally.
- Cash Management: To fund this, DBV completed a financing of up to $306.9 million in 2025, with $125.5 million received in April 2025. This capital is critical, as operating expenses totaled $107.0 million for the nine months ended September 30, 2025.
- Pipeline Expansion: Beyond Viaskin Peanut, the company is advancing Viaskin Milk and is exploring other allergens (like cashew) and non-allergy conditions (e.g., celiac disease) to broaden the platform's application.
- Diagnostic Tool Development: DBV has a collaboration with Nestlé Health Science for MAG1C, a ready-to-use atopy patch test. This diversifies their offering slightly into diagnostics for non-IgE mediated CMPA in infants.
Here's the quick math: The company had $69.8 million in cash and equivalents as of September 30, 2025, and is burning cash at a rate that suggests its runway extends into the third quarter of 2026. That's a tight window, so a positive VITESSE readout is defintely a high-priority event.
For a deeper dive into the capital structure, you should be Exploring DBV Technologies S.A. (DBVT) Investor Profile: Who's Buying and Why?
DBV Technologies' Strategic Advantages
The company's market success, if approved, will be driven by the unique benefits of its core technology, positioning it favorably against existing, more invasive treatments.
- Proprietary EPIT Technology: The Viaskin patch is a distinct, non-invasive method of immunotherapy. It delivers the allergen to the dendritic cells in the skin's outer layer, avoiding systemic exposure and potential severe reactions common with oral immunotherapy (OIT).
- Favorable Safety Profile: Compared to OIT, Viaskin Peanut is anticipated to offer a safer and more convenient treatment option for young children, which is a massive selling point for parents and physicians.
- Early Intervention Focus: The company is strategically targeting the youngest patient populations (1-3 years and 4-7 years), where early intervention is believed to be most effective and where the competitive landscape is less crowded than in older age groups.
- Clear Regulatory Path: Alignment with the FDA on an Accelerated Approval Pathway for the toddler indication significantly de-risks that program and provides a defined path to potential market entry.
DBV Technologies S.A. (DBVT) How It Makes Money
DBV Technologies S.A. is a clinical-stage biopharmaceutical company, meaning it does not currently generate revenue from commercial product sales. Instead, the company sustains its operations and funds its extensive research and development (R&D) pipeline, primarily Viaskin Peanut, through a combination of non-dilutive government funding, like research tax credits, and strategic financing activities, such as private placements and at-the-market (ATM) offerings.
DBV Technologies S.A.'s Revenue Breakdown
For the nine months ended September 30, 2025, DBV Technologies S.A.'s operating income totaled $5.0 million. This figure is essentially a single-source stream, reflecting the financial structure of a company focused solely on advancing its clinical pipeline toward regulatory approval and commercialization.
| Revenue Stream | % of Total (Operating Income) | Growth Trend |
|---|---|---|
| Research Tax Credits (France) | 100% | Increasing |
| Collaboration and Licensing Revenue | 0% | Stable (at zero) |
The company's operating income is derived entirely from the French Research Tax Credit (Crédit d'Impôt Recherche or CIR) for the nine months ended September 30, 2025. This credit amounted to $5.0 million, up from $3.6 million in the same period a year prior, reflecting more eligible R&D activities carried out during the period. That's a 38.9% increase in this critical funding source. Honestly, without product sales, this tax credit is the lifeblood of their reported operating income.
Business Economics
The core economic model for DBV Technologies S.A. is a high-risk, high-reward biopharma play, betting on the successful regulatory approval and subsequent commercial launch of its lead product candidate, Viaskin Peanut, for peanut allergy treatment. The current economics are defined by significant cash burn, funded by capital raises, to support the R&D necessary for future product revenue.
- Pricing Strategy: The future pricing model for Viaskin Peanut is expected to be premium, aligning with other specialty allergy and immunologic treatments, given the lack of a curative option for peanut allergy.
- Cost Structure: The business is dominated by Research & Development (R&D) expenses, which totaled $83.8 million for the nine months ended September 30, 2025. This is the main cost driver, funding ongoing clinical trials like the COMFORT Toddlers study.
- Economic Gate: The entire financial future hinges on the Biologics License Application (BLA) submission and potential U.S. commercial launch, which would transition the company from a purely R&D-driven cost center to a product-revenue generator.
The company is essentially a venture-backed entity operating on a burn rate, where the return on investment is realized only upon commercialization. You can get more context on their long-term goals by reading their Mission Statement, Vision, & Core Values of DBV Technologies S.A. (DBVT).
DBV Technologies S.A.'s Financial Performance
The financial health of DBV Technologies S.A. as of late 2025 is characterized by a strong cash infusion from recent financing, but still a substantial net loss reflecting its pre-commercial status. The key financial metrics tell a clear story of a company deep in the clinical development phase.
- Net Loss: The net loss for the nine months ended September 30, 2025, was $102.1 million, an increase from the $90.9 million loss in the same period in 2024. This loss is expected for a company in this stage, but it defintely highlights the high cost of clinical trials.
- Cash Position: Cash and cash equivalents stood at $69.8 million as of September 30, 2025, a significant improvement from $32.5 million at the end of 2024, largely due to a financing operation.
- Operating Cash Flow: Net cash flows used in operating activities were $86.0 million for the nine months ended September 30, 2025, which is the actual cash burn rate you should be watching.
- Cash Runway: Based on current operations, the company estimates its cash and cash equivalents are sufficient to fund operations into the third quarter of 2026. This runway extension was secured by a $125.5 million upfront gross proceeds from a Private Investment in Public Equity (PIPE) financing completed in April 2025.
Here's the quick math: the $86.0 million operating cash use over nine months translates to an average monthly burn of about $9.56 million. What this estimate hides is the potential for increased costs as the company ramps up Biologics License Application (BLA) preparation, so that runway estimate is a best-case scenario.
DBV Technologies S.A. (DBVT) Market Position & Future Outlook
DBV Technologies S.A. is currently a high-risk, high-reward clinical-stage company whose market position is defined by the imminent Phase III VITESSE trial results for its Viaskin Peanut patch, a potential breakthrough in epicutaneous immunotherapy (EPIT). The company's future hinges on a successful regulatory path to capture a share of the rapidly growing global peanut allergy treatment market, which is valued at approximately $590.9 million in 2025.
Competitive Landscape
In the food allergy immunotherapy space, DBV Technologies is a challenger to the established oral immunotherapy (OIT) leader, Aimmune Therapeutics. The core of DBV's competitive advantage is its non-invasive, patch-based delivery system, which offers a potentially safer and more convenient alternative to OIT, especially for children who struggle with daily ingestion of an allergen.
| Company | Market Share, % | Key Advantage |
|---|---|---|
| DBV Technologies S.A. | <1% | Proprietary Viaskin EPIT (patch) technology; Non-invasive, high patient compliance potential. |
| Aimmune Therapeutics (Nestlé Health Science) | 82.7% | First-to-market, FDA-approved Oral Immunotherapy (OIT) with Palforzia; Established commercial infrastructure. |
| Regeneron Pharmaceuticals / Novartis | Emerging | Biologic therapy (Omalizumab/XOLAIR) approved for multiple food allergies; Targets a broader patient population including adults. |
Opportunities & Challenges
Your investment thesis here must weigh the near-term clinical catalyst against the company's financial runway. The topline data from VITESSE in Q4 2025 is the single most important factor. If positive, it will unlock a market opportunity analysts project could secure DBV a 5%-10% market share by 2030, translating to significant revenue.
| Opportunities | Risks |
|---|---|
| Positive Phase III VITESSE data in Q4 2025 for 4-7-year-olds; paves way for BLA filing. | Negative or inconclusive VITESSE trial results, which would halt all near-term commercialization plans. |
| Viaskin's non-invasive EPIT platform is a strong differentiator against Palforzia's OIT, which carries a higher risk of systemic reactions. | Cash runway is limited; cash and cash equivalents of $103.2 million as of June 30, 2025, fund operations only into Q2 2026. |
| Accelerated BLA submission pathway for 4-7-year-olds in the first half of 2026, targeting a large pediatric patient pool. | Significant competition from the OIT leader and emerging biologic therapies like Omalizumab/XOLAIR. |
| Expansion into younger demographics (1-3 years and 6-12 months) with planned Phase 2 studies, securing a long-term pipeline. | Potential for substantial shareholder dilution from the $150 million At-The-Market (ATM) financing program. |
Industry Position
DBV Technologies is positioned as a critical innovator in the food allergy immunotherapy market, not a current market leader. The company is a clinical-stage entity with a forecast annual revenue of only $76.52 million for 2025, which primarily comes from research tax credits and collaborations, not product sales.
The company's standing is entirely dependent on its Viaskin technology, which holds a U.S. FDA Breakthrough Therapy Designation. Your focus should be on the clinical timeline, not current sales. The net loss for the first half of 2025 was $69.0 million, so the burn rate is real. This is a defintely a binary-event stock right now.
- Technology Differentiation: EPIT (Epicutaneous Immunotherapy) is a non-invasive, needle-free method that delivers allergen through the skin, a key advantage over oral therapies that require ingestion.
- Market Potential: The Viaskin patch is targeting the most common food allergy, peanut, which represents the largest clinical and commercial opportunity, commanding an estimated 84.5% of the food allergy immunotherapy market in 2025.
- Strategic Focus: Recent appointment of a Chief Commercial Officer and the $150 million financing program in September 2025 signal a clear shift from pure R&D to commercial readiness, anticipating regulatory success.
To understand the foundational strategy driving this commercial push, you should review the Mission Statement, Vision, & Core Values of DBV Technologies S.A. (DBVT).

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