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DBV Technologies S.A. (DBVT): Business Model Canvas [Dec-2025 Updated] |
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You're looking at a clinical-stage biotech right on the cusp of a massive inflection point, and honestly, understanding the mechanics behind DBV Technologies S.A.'s current runway is key. They're betting the farm on Viaskin Peanut, aiming for a non-invasive, once-daily patch treatment for peanut allergy, but the near-term reality shows a high burn rate-R&D expenses totaled $83.8 million for the first nine months of 2025. Still, they've got the capital structure to see that critical Biologics License Application (BLA) submission through, having banked $125.5 million from a 2025 PIPE, leaving them with $69.8 million in cash as of September 30, 2025. This canvas breaks down exactly how DBV Technologies S.A. is funding this race to market and what key resources, from their proprietary EPIT platform to institutional investors, are lined up for that potential US launch, so dive in to see the full picture.
DBV Technologies S.A. (DBVT) - Canvas Business Model: Key Partnerships
You're looking at the critical relationships DBV Technologies S.A. (DBVT) relies on to push Viaskin Peanut toward commercialization, especially after securing major funding in 2025. These aren't just names on a slide; they represent capital, execution capability, and scientific validation.
Institutional Investors for Financing
Financing is the lifeblood for a clinical-stage company, and the partnership with institutional investors was key in 2025. DBV Technologies announced a significant financing on March 27, 2025, structured to support the Biologics License Application (BLA) submission and potential U.S. commercial launch.
The total commitment reached up to $306.9 million (or €284.5 million). This capital injection was led by MPM BioImpact, alongside Adage Capital Management LP, Janus Henderson Investors, Vivo Capital, Octagon Capital, Surveyor Capital (a Citadel company), Bpifrance Participations, and Yiheng Capital.
Here's the quick math on the initial tranche:
| Financing Component | Amount (USD) | Amount (EUR) | Date Received/Expected |
| Gross Proceeds at Closing | $125.5 million | €116.3 million | April 7, 2025 |
| Potential Proceeds from Warrants | Up to $181.4 million | Up to €168.2 million | Subject to exercise |
This funding immediately improved the balance sheet. As of June 30, 2025, the cash position stood at $103.2 million, which the Company estimated was sufficient to fund operations into the second quarter of 2026. Also, in September 2025, DBV Technologies established an equity offering program (ATM Program), from which they received approximately $30 million in gross proceeds on October 6, 2025.
Clinical Research Organizations (CROs) for Global Trials
Managing a pivotal Phase 3 trial like VITESSE requires robust external execution, which is where specialized CROs and site networks come in. The VITESSE trial is the largest treatment intervention study conducted in peanut allergy to date.
The partnership structure for VITESSE involved:
- Trial Size: Enrolled 654 peanut-allergic children aged 4-7 years.
- Geographic Reach: Conducted across 86 sites.
- Geographic Footprint: Sites spanned the U.S., Canada, Europe, the UK, and Australia.
- Data Milestone: The last patient visit was completed in November 2025, with topline data expected in the fourth quarter of 2025.
The trial design itself was a randomized (2:1) double-blind, placebo-controlled study, a structure agreed upon following exchanges with the FDA. If onboarding takes 14+ days, churn risk rises, so efficient site management by the CROs was defintely critical.
Key Opinion Leaders (KOLs) and Allergists
Scientific advocacy and trial design input come directly from established Key Opinion Leaders (KOLs) and practicing allergists. These partnerships lend credibility and shape future development strategy.
DBV Technologies actively engaged with the allergy community in 2025, for example, at the American College of Allergy, Asthma & Immunology (ACAAI) 2025 Annual Scientific Meeting. A panel of renowned allergists participated in a Product Theater, including:
- Dr. Gideon Lack
- Dr. Hugh Sampson
- Dr. George du Toit
- Dr. Kirsten Perrett
- Dr. Matthew Greenhawt
This engagement directly informed future studies. Dr. Perrett presented details of a planned Phase 2 clinical study to assess the Viaskin Peanut patch in peanut-allergic infants aged 6 through 12 months, following a minimum of 3 years of treatment. Furthermore, a symposium at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025 was co-chaired by Prof Gideon Lack and Prof Alexandra Santos.
Manufacturing Partners for Patch Production
Securing reliable, scalable manufacturing is non-negotiable for a device-drug combination product. While a historical agreement with Sanofi was noted, the operational costs related to the FAREVA platform were specifically reflected in the 2025 financial reporting.
The costs associated with the FAREVA platform contributed to the Research tax credit figures for the nine months ended September 30, 2025. The Research tax credits recognized were:
| Period Ended September 30, 2025 | Period Ended September 30, 2024 |
| $5.0 million (nine months) | $3.6 million (nine months) |
This increase in the tax credit is primarily due to more eligible activities being carried out, including the related costs of the FAREVA platform itself. Finance: draft 13-week cash view by Friday.
DBV Technologies S.A. (DBVT) - Canvas Business Model: Key Activities
The Key Activities for DBV Technologies S.A. (DBVT) center on advancing its Viaskin EPIT platform through late-stage clinical development and securing the necessary capital to reach regulatory milestones as of late 2025.
Executing late-stage clinical trials (VITESSE Phase 3, COMFORT Toddlers study)
The execution of late-stage trials is a primary focus. The VITESSE Phase 3 clinical trial, evaluating the Viaskin Peanut patch in peanut allergic children aged 4-7 years, reached a major milestone with the last patient visit completed as of November 12, 2025. This 12-month, double-blind, placebo-controlled study represents the largest treatment intervention study in peanut allergy, enrolling 654 subjects across 86 sites in the US, Canada, Europe, the UK, and Australia. Topline results for VITESSE are on track for the fourth quarter of 2025.
For the younger population, the COMFORT Toddlers supplemental safety study, supporting the Biologics License Application (BLA) for toddlers aged 1-3 years under the Accelerated Approval pathway, was on-track to initiate in the second quarter of 2025. This study anticipates enrolling approximately 300 - 350 subjects on active treatment, aiming to bring the total Viaskin Peanut patch safety database in toddlers to approximately 600 subjects.
Here is a snapshot of the late-stage trial status:
| Study | Indication Age Group | Status/Key Milestone | Expected Data Readout/Submission |
| VITESSE Phase 3 | 4 - 7 years-old | Last patient visit completed; 654 subjects enrolled | Topline data in Q4 2025 |
| COMFORT Toddlers | 1 - 3 years-old | Study initiation planned for Q2 2025; targeting 300 - 350 active subjects | BLA submission anticipated for 2H 2026 |
Preparing Biologics License Application (BLA) submission to the FDA
The company is actively preparing for regulatory submissions based on clinical progress. Following alignment with the U.S. Food and Drug Administration (FDA), DBV Technologies plans to submit the BLA for the Viaskin peanut patch in children aged 4-7 years in the first half of 2026 (1H 2026), supported by the VITESSE Phase 3 study. This timeline potentially accelerates the product launch by approximately one year, subject to FDA approval.
For the toddler indication (1-3 years-old), the BLA submission under the Accelerated Approval program is anticipated for the second half of 2026 (2H 2026), contingent upon the successful completion of the COMFORT Toddlers study. The financing secured in 2025 is intended to finance the preparation and submission of this potential BLA.
Research and Development (R&D) on the proprietary Viaskin EPIT platform
Key activities involve the continued development and support of the proprietary Epicutaneous Immunotherapy (EPIT) platform, which uses the skin's immune-tolerizing properties to re-educate the immune system against allergens. The financial impact of these activities is reflected in operating expenses. Operating expenses for the nine months ended September 30, 2025, were $107.0 million, an increase from $96.4 million for the same period in 2024.
The increase in operating expenses for the nine months ended September 30, 2025, was driven mostly by the launch of the COMFORT Toddlers supplemental safety study. For context, Research & Development costs for the full year ended December 31, 2024, amounted to $29.1 million.
Securing capital through equity offerings (e.g., $30 million ATM program)
Sustaining operations and funding clinical trials requires continuous capital generation. DBV Technologies announced a sale of approximately $30 million in gross proceeds through its At-The-Market (ATM) program on October 29, 2025. This ATM program was established on September 5, 2025. One specific transaction on October 6, 2025, involved issuing 2,307,692 new ADSs at $13.00 per ADS for approximately $30 million gross proceeds.
This followed a larger financing announced on March 27, 2025, of up to $306.9 million, which included gross proceeds of $125.5 million received upfront on April 7, 2025. With the receipt of the April 7 proceeds, the company estimated its cash and cash equivalents would be sufficient to fund operations into the second quarter of 2026. Cash and cash equivalents stood at $69.8 million as of September 30, 2025, compared to $32.5 million at the end of 2024.
The company utilized equity offerings to manage its cash burn, reporting a net loss of $102.1 million for the nine months ended September 30, 2025. Finance: draft 13-week cash view by Friday.
DBV Technologies S.A. (DBVT) - Canvas Business Model: Key Resources
For DBV Technologies S.A., the Key Resources are centered around its proprietary science, the resulting intellectual property, and the financial backing to advance its clinical pipeline, particularly the Viaskin® Peanut patch.
Proprietary Viaskin® technology and Epicutaneous Immunotherapy (EPIT) platform represent the core scientific asset. This platform is the delivery system for the active immunotherapy agents, designed for epicutaneous (on the skin) administration. The focus remains on advancing Viaskin Peanut through Biologics License Application (BLA) submission and potential U.S. commercial launch.
The financial health, as of the third quarter of 2025, provides a critical resource for sustaining operations. You need to know the balance sheet strength to support the path to market.
| Financial Metric | Amount as of September 30, 2025 | Context/Date |
| Cash and Cash Equivalents | $69.8 million | End of Q3 2025 |
| Gross Proceeds from 2025 PIPE | $125.5 million | Received on April 7, 2025 |
| Subsequent ATM Proceeds | Approximately $30 million | Received on October 6, 2025 |
| Estimated Cash Runway | Into the third quarter of 2026 | As of October 28, 2025 |
| R&D Operating Expenses (9M 2025) | $83.8 million | Nine months ended September 30, 2025 |
The Intellectual property portfolio is the legal moat protecting the Viaskin patch design and the EPIT method itself. While a specific patent count isn't readily available for late 2025, the value is intrinsically tied to the regulatory pathway of Viaskin Peanut.
Human capital, specifically the Specialized R&D and regulatory personnel in France and the US, is essential for executing the clinical trials and regulatory filings. The commitment to this resource is reflected in the operating expenses. For instance, operating expenses for Research & Development amounted to $83.8 million for the nine months ended September 30, 2025. The overall employee count was reported in the range of 51 - 200 as of July 01, 2024, which supports the specialized teams needed for development and compliance across geographies.
You can also look at the operational burn rate to gauge resource utilization:
- Net cash flows used in operating activities for the nine months ended September 30, 2025, were $86.0 million.
- The Company recorded a net loss for the nine months ended September 30, 2025, of $102.1 million.
Finance: draft 13-week cash view by Friday.
DBV Technologies S.A. (DBVT) - Canvas Business Model: Value Propositions
You're looking at the core value DBV Technologies S.A. (DBVT) is promising to deliver with its Viaskin Peanut program. It's all about offering a significant shift in how peanut allergy is managed, especially for the youngest patients.
Non-invasive, once-daily patch treatment for peanut allergy is the headline. This is rooted in their proprietary investigational EPIT (Epicutaneous Immunotherapy) technology, which is designed to induce immune response by introducing minimal amounts of peanut antigen through intact skin. This contrasts sharply with existing methods that often require oral ingestion of the allergen.
The value proposition centers on being a potential disease-modifying therapy for life-threatening food allergies. Peanut allergy is a major concern; in the US, it affects an estimated 390,000 children. The broader food allergy market in leading markets was valued at USD 3 billion in 2024, with the US representing about 79% of that size. Analysts like Guggenheim project $2 billion in peak sales for Viaskin Peanut upon approval, underscoring the potential market impact.
The Viaskin Peanut patch specifically targeting allergic children and toddlers is key to their near-term strategy. They are advancing two product candidates:
- Children aged 4 through 7 years, supported by the VITESSE Phase 3 study.
- Toddlers aged one through three years, supported by the COMFORT Toddlers study.
The VITESSE trial, which completed its last patient visit in November 2025, is the largest treatment intervention study ever conducted in peanut allergy for that age group, enrolling 654 subjects randomized 2:1 across 86 sites. Topline results are expected in the fourth quarter of 2025, with a Biologics License Application (BLA) submission targeted for the first half of 2026.
This approach offers a safer, patient-friendly alternative to oral immunotherapy (OIT). The non-invasive skin application is designed to mitigate the risks associated with systemic exposure. For the younger group (1-3 years), the COMFORT Toddlers study, aiming to enroll 300-350 subjects, is set to support a BLA submission in the second half of 2026 under the Accelerated Approval pathway.
Here's a quick look at the scale of the development effort supporting this value proposition as of late 2025:
| Metric | Value/Target | Context |
|---|---|---|
| VITESSE Trial Subjects | 654 | Phase 3 for 4-7 year olds (Randomized 2:1) |
| VITESSE Sites | 86 | Across U.S., Canada, Europe, UK, Australia |
| COMFORT Toddlers Subjects | 300-350 | Target enrollment for supplemental safety study |
| Projected Peak Sales (Analyst) | $2 billion | Guggenheim projection for Viaskin Peanut |
| US Peanut Allergic Children (Est.) | 390,000 | Target population for the US market |
Financially, DBV Technologies S.A. secured significant funding, receiving gross proceeds of $125.5 million (€116.3 million) in April 2025 from a larger financing package, intended to advance Viaskin Peanut through BLA submission and potential US commercial launch. As of September 30, 2025, cash and cash equivalents stood at $69.8 million. The company recorded a net loss of $102.1 million for the nine months ended September 30, 2025.
The core value is the potential for a convenient, non-invasive, daily treatment that could modify the course of a life-threatening condition, which is why analysts are assigning significant value to the impending Q4 2025 topline data.
Finance: review cash burn rate against runway funded by the April 2025 financing by end of next week.
DBV Technologies S.A. (DBVT) - Canvas Business Model: Customer Relationships
You're looking at how DBV Technologies S.A. manages its relationships with the key groups that drive its clinical development and future commercial success. For a clinical-stage biopharma like DBV Technologies, these relationships are about trust, scientific validation, and securing the capital to reach the finish line.
High-touch engagement with clinical investigators and allergists
The relationship with clinical investigators and the broader allergist community is critical, as they are the gatekeepers for trial participation and future prescription adoption. Engagement is centered around presenting robust clinical data and planning future studies.
As of late 2025, DBV Technologies announced the Last Patient Visit Completed in the VITESSE Phase 3 clinical trial for the VIASKIN Peanut patch in peanut-allergic children aged 4 through 7 years as of November 11, 2025. This milestone directly involves the investigators who managed those sites.
The company is already planning the next steps, detailing a planned Phase 2 clinical study to assess the efficacy and safety of the VIASKIN Peanut patch in peanut-allergic infants aged 6 through 12 months of age following a minimum of 3 years of treatment. This requires deep collaboration with key opinion leaders (KOLs) in early intervention.
High-touch scientific engagement is evident through participation in major medical meetings. For instance, at the American College of Allergy, Asthma & Immunology (ACAAI) 2025 Annual Scientific Meeting in November 2025, DBV Technologies hosted a Product Theater featuring a panel of renowned allergists, including Drs. Gideon Lack, Hugh Sampson, George du Toit, Kirsten Perrett, and Matthew Greenhawt.
The executive team maintains direct contact with the investment community, which indirectly supports the clinical narrative by ensuring funding. CEO Daniel Tassé participated in multiple investor-facing events in 2025, such as the Guggenheim 2nd Annual Healthcare Innovation Conference on November 11 and the H.C. Wainwright 27th Annual Global Investment Conference on September 9.
Investor relations for continuous financing updates and capital raising
For DBV Technologies, investor relations is less about quarterly sales updates and more about transparently communicating clinical progress against funding needs. You need to know the cash position to gauge operational runway.
The company closed Q3 2025 with cash and cash equivalents of $69.8 million as of September 30, 2025, a significant increase from $32.5 million at the end of 2024. This liquidity was bolstered by a major financing event earlier in the year.
On April 7, 2025, DBV Technologies received gross proceeds of $125.5 million (€116.3 million) as part of a larger financing announced on March 27, 2025, which was for up to $306.9 million (€284.5 million). This capital was earmarked to advance the Viaskin Peanut patch through Biologics License Application (BLA) submission and U.S. commercial launch readiness.
Further bolstering liquidity post-Q3, the company announced on October 6, 2025, that it raised approximately $30 million gross from an At-The-Market (ATM) Program sale. This ATM Program, established in September 2025, allows for the issuance of American Depositary Shares (ADSs) up to an aggregate offering price of $150.0 million. As of the October 28, 2025, filing, the company estimated its cash was sufficient to fund operations into the third quarter of 2026.
Here's a quick look at the financing activity that directly impacts the cash position:
| Financial Metric/Event | Amount (USD) | Date/Period End |
|---|---|---|
| Cash & Cash Equivalents | $69.8 million | September 30, 2025 |
| Gross Proceeds from April 2025 Financing (Upfront) | $125.5 million | April 7, 2025 |
| Gross Proceeds from October 2025 ATM Sale | Approx. $30 million | October 6, 2025 |
| Net Cash Flows from Financing Activities (9M 2025) | $117.1 million | Nine Months Ended Sep 30, 2025 |
| Estimated Cash Runway | Into Q3 2026 | As of October 28, 2025 |
The market is reacting to this progress; for example, in early December 2025, Guggenheim initiated coverage with a Buy rating and a price target of $35.00 USD.
Direct communication with patient advocacy groups and families
Engaging with patient advocacy groups is essential for demonstrating a patient-centric approach, which regulators increasingly value. DBV Technologies is focused on food allergies, a condition affecting millions of people, including young children.
The clinical trial design itself reflects direct engagement with the needs of families. The VITESSE trial focused on children aged 4 through 7 years, and the planned Phase 2 study targets infants aged 6 through 12 months. This focus on both older children and infants shows a commitment to addressing needs across different pediatric age groups.
While specific 2025 metrics on the number of formal advocacy group partnerships aren't public, the general industry trend shows that pharmaceutical companies are stepping up engagement to refine strategies, as drug regulators now regularly seek input from patient groups to validate treatment relevance. DBV Technologies' commitment to non-invasive epicutaneous immunotherapy (EPIT) aligns with the patient desire for less burdensome treatment modalities.
Key stakeholders in the patient community are informed through specific updates, such as the June 25, 2025, DBV COMFORT Toddlers Update Investor Call, which speaks directly to families involved in that cohort.
You can see the direct communication channels used for investor/stakeholder outreach:
- Investor Relations Contact: Katie Matthews at +1 857-529-2563.
- Shareholder document requests for the June 11, 2025, General Meeting were handled via investors@dbv-technologies.com.
- The company maintains a presence on X (formerly Twitter) and LinkedIn for broader engagement.
Finance: draft 13-week cash view by Friday.
DBV Technologies S.A. (DBVT) - Canvas Business Model: Channels
You're looking at how DBV Technologies S.A. gets its product development data out and how it plans to get its potential product, the Viaskin Peanut patch, to patients. For a clinical-stage company, the channels are split between scientific validation and future commercial readiness.
Clinical trial sites for product development and patient access
The core channel for product development is the network of clinical trial sites conducting studies like VITESSE. This network is crucial for generating the data needed for regulatory submissions, such as the Biologics License Application (BLA) planned for the first half of 2026 for the 4-7-year-old indication. The VITESSE Phase 3 trial, which DBV Technologies S.A. described as the largest treatment intervention study in peanut allergy, involved 654 subjects randomized in a 2:1 ratio across 86 sites. These sites spanned the U.S., Canada, Europe, the UK, and Australia. The last patient visit in this pivotal study was completed in November 2025, keeping the topline data readout on track for the fourth quarter of 2025. For the younger patient group (1-3 years), the COMFORT Toddlers supplemental safety study is planned to recruit approximately 480 study participants. The company, as of late 2025, operates with 110 employees.
The financial outlay for these channels is significant, as seen in the Q1 2025 results where $19.7 million of cash was used in operating activities, mainly for external clinical trial related expenses. To fund the path to potential commercial launch, DBV Technologies S.A. secured financing, including gross proceeds of $125.5 million (€116.3 million) received on April 7, 2025, from a larger potential financing of up to $306.9 million (€284.5 million).
Scientific conferences (e.g., ACAAI 2025) for data dissemination
Disseminating trial progress and scientific rationale through peer-reviewed channels is a key channel for building credibility with clinicians and investors. DBV Technologies S.A. was active across major allergy meetings in 2025.
- Participated in the American College of Allergy, Asthma, and Immunology (ACAAI) 2025 Annual Scientific Meeting from November 6 - 10 in Orlando, Florida.
- Presented data at the Eastern Allergy Conference from May 29-June 1, 2025.
- Presented posters at the European Academy of Allergy and Clinical Immunology (EAACI) 2025 Annual Meeting, June 13-16, 2025.
- CEO Daniel Tassé presented at the Citizens JMP Life Sciences Conference on May 7, 2025.
These presentations served to discuss evidence supporting earlier intervention and present data from ongoing or recently completed studies, such as the VITESSE trial and the COMFORT Toddlers study.
Future specialty pharmaceutical distribution network for commercial launch
Preparing for a potential U.S. Commercial Launch post-BLA submission requires establishing a distribution channel strategy. This involves navigating the complex landscape of specialty pharmaceuticals, where manufacturers often limit dispensing to specific pharmacies. The industry context in 2025 involves mastering models like limited or exclusive dispensing networks and managing regulatory changes like DSCSA serialization. DBV Technologies S.A. is preparing for this by securing capital, having established a new At-The-Market (ATM) equity offering program on September 5, 2025, allowing sales of up to $150.0 million in American Depositary Shares (ADSs). A recent transaction under this program involved selling approximately $30 million of ADSs on October 31, 2025. The cash and cash equivalents balance as of September 30, 2025, stood at $69.8 million.
Here is a snapshot of key operational and financial figures relevant to these channels as of late 2025:
| Metric Category | Channel/Activity | 2025 Data Point |
| Clinical Operations | VITESSE Phase 3 Subjects | 654 |
| Clinical Operations | VITESSE Trial Sites | 86 |
| Clinical Operations | COMFORT Toddlers Target Enrollment | Approx. 480 Subjects |
| Data Dissemination | ACAAI 2025 Dates | November 6 - 10 |
| Data Dissemination | EAACI 2025 Dates | June 13-16 |
| Financial/Funding | Q1 2025 Clinical Trial Expenses | $19.7 million |
| Financial/Funding | Cash as of September 30, 2025 | $69.8 million |
| Future Launch Prep | New ATM Program Size (Sept 2025) | Up to $150.0 million |
| Future Launch Prep | ADS Sale Proceeds (Oct 2025) | Approx. $30 million |
The company is targeting a BLA submission in the first half of 2026, which will be the trigger for fully activating the specialty distribution channel strategy.
DBV Technologies S.A. (DBVT) - Canvas Business Model: Customer Segments
You're looking at the core patient and financial base that DBV Technologies S.A. is targeting with its epicutaneous immunotherapy (EPIT) approach. This is a clinical-stage company, so the customer segments are defined by clinical trial enrollment and the addressable market for their lead product, the Viaskin Peanut patch.
Pediatric allergists and immunologists (key prescribers)
These are the gatekeepers who will ultimately prescribe the Viaskin Peanut patch upon regulatory approval. DBV Technologies is clearly focused on establishing a strong presence where the need is greatest, as evidenced by the geographic spread of its pivotal trial sites.
- VITESSE Phase 3 trial was conducted across 86 sites in the United States, Canada, Europe, the United Kingdom, and Australia.
- The company appointed a Chief Commercial Officer in November 2025, signaling readiness for market engagement with prescribers.
Peanut-allergic children aged 4-7 years (VITESSE target)
This segment is the immediate focus for the first potential Biologics License Application (BLA) submission, which is supported by the VITESSE study data expected in Q4 2025.
The addressable market size in the United States alone is substantial, which drives the high peak sales projections analysts are using.
| Metric | Number/Amount | Context/Date |
| US Target Population Estimate | 390,000 children | Target for BLA submission |
| VITESSE Trial Enrollment | 654 subjects | Phase 3 efficacy trial |
| VITESSE Topline Data Expected | Fourth quarter of 2025 | Critical milestone |
| Projected Peak Sales (if approved) | $2 billion | Analyst projection |
Peanut-allergic toddlers aged 1-3 years (COMFORT target)
This younger cohort is targeted via an Accelerated Approval pathway, contingent on the COMFORT-TODDLER safety study. The clinical data supporting this segment comes from the earlier EPITOPE trial.
The company is pushing to gather the necessary safety data to support a BLA submission for this group potentially in the second half of 2026.
- EPITOPE Phase 3 trial enrolled 362 peanut-allergic toddlers.
- The COMFORT Toddlers supplemental safety study planned to initiate in Q2 2025.
- The COMFORT study anticipates enrolling approximately 300 - 350 subjects on active treatment.
Institutional investors funding the clinical-stage operations
As a clinical-stage company, DBV Technologies S.A. relies heavily on capital markets and institutional backing to fund its operations, especially given the high cost of late-stage trials. The ownership structure reflects significant conviction from financial players.
The company's enterprise value was approximately $1 billion as of late 2025, and its cash burn requires ongoing investor support.
| Ownership Group | Stake/Count | Latest Data Point |
| Institutional Investors Holding | 71.74% of stock | As of Q3 2025 |
| Number of Institutional Holders | 19 | Over the previous two years |
| Private Equity Stake | 8.0% | Ownership percentage |
| Net Cash Used in Operating Activities (9M 2025) | $86.0 million | Nine months ended September 30, 2025 |
For the nine months ended September 30, 2025, the net loss recorded was $102.1 million USD/share, or ($0.82) USD/share on a per share basis. The negative free cash flow over the last twelve months was reported at $98.29 million.
DBV Technologies S.A. (DBVT) - Canvas Business Model: Cost Structure
You're looking at the core spending engine for DBV Technologies S.A. (DBVT) as they push toward potential commercialization. For a clinical-stage company, the cost structure is almost entirely driven by the science and the path to the FDA. Here's what the numbers from the first nine months of 2025 tell us about where the cash is going.
Research & Development (R&D) is, as expected, the single largest cost center. This is the price of admission for developing Viaskin Peanut and other pipeline assets. For the nine months ended September 30, 2025, R&D costs hit $83.8 million. This is a significant jump from the $70.4 million spent in the same period in 2024, showing increased activity as they progress toward key milestones. Honestly, this is the number you watch most closely.
The total operating expenses for the nine months ended September 30, 2025, were $107.0 million. This increase of $10.6 million over the prior year's nine-month spend was driven mostly by the launch of the COMFORT Toddlers supplemental safety study. That study is a direct R&D cost, but it signals the operational scale-up required for post-BLA activities or to satisfy ongoing regulatory requirements.
The cost structure breakdown for the nine months ended September 30, 2025, looks like this:
| Expense Category | Amount (9M 2025, in millions USD) | Comparison to 9M 2024 (in millions USD) |
| Research & Development (R&D) | $83.8 | Increase of $13.4 million |
| General & Administrative (G&A) | $21.3 | Decrease of $2.4 million |
| Sales & Marketing (S&M) | $1.9 | Decrease of $0.4 million |
| Total Operating Expenses | $107.0 | Increase of $10.6 million |
Clinical trial expenses are embedded within that R&D figure. You see the direct cash burn related to trials when looking at operating cash flows. For instance, in the first quarter of 2025, cash used in operating activities was $19.7 million, which was mainly attributed to external clinical trial related expenses, specifically progress on subject enrollment in the VITESSE Phase 3 clinical trial.
Costs for regulatory submission and pre-commercial launch readiness are a critical, forward-looking expense. While not broken out separately for the nine-month period, the financing announced in April 2025-up to $306.9 million with $125.5 million received upfront-was explicitly earmarked to advance the Viaskin Peanut patch through Biologics License Application (BLA) submission and U.S. commercial launch, if approved. This shows the scale of capital required to cover these specific, non-R&D-trial costs.
Here are the key cost drivers and related activities:
- R&D spending for 9M 2025: $83.8 million.
- G&A for 9M 2025: $21.3 million.
- Primary R&D driver in 2025: Launch of the COMFORT Toddlers supplemental safety study.
- Q1 2025 cash used for clinical/regulatory: $19.7 million.
- Pre-commercial funding secured: Up to $306.9 million.
The G&A expense of $21.3 million for the nine months ended September 30, 2025, actually reflects cost discipline, as it was lower than the $23.7 million reported for the same period in 2024. This reduction was partly due to the absence of one-time costs associated with office moves in France and the U.S. that impacted 2024 figures. It's a good sign that overhead is being managed while the core science spend increases. Finance: draft 13-week cash view by Friday.
DBV Technologies S.A. (DBVT) - Canvas Business Model: Revenue Streams
You're looking at the current, hard numbers driving DBV Technologies S.A.'s operations as of late 2025, focusing strictly on where the cash is coming from right now, not just what they hope to sell later. For a clinical-stage company, these non-sales revenue sources are absolutely critical for funding the path to market.
The most significant immediate cash infusion came from equity financing events designed to push Viaskin Peanut toward a potential U.S. commercial launch.
- Proceeds from equity financing, including $125.5 million from the 2025 PIPE, which closed with initial gross proceeds received on April 7, 2025.
- An additional gross amount of approximately $30 million was received on October 6, 2025, from the new ATM Program established in September 2025.
- The total potential financing from the 2025 PIPE was up to $306.9 million, with up to $181.4 million contingent upon the exercise of warrants.
Non-product operating income provides a steady, albeit smaller, stream to offset costs. This is often government support or non-sales revenue recognized in the period.
For the nine months ended September 30, 2025, the Research tax credits and other operating income totaled $5.0 million. That's the total Operating Income reported for that nine-month period. This compares to $3.6 million recorded for the same nine months in 2024.
Here's a quick look at how the operating income components stacked up for the first nine months of 2025:
| Income/Expense Component (9M 2025) | Amount (in millions of USD) | Comparison to 9M 2024 (in millions of USD) |
| Research tax credits | 5.0 | 3.6 |
| Total Operating income | 5.0 | 3.6 |
The future revenue picture is entirely dependent on regulatory success. You know the drill here; no approval, no product sales.
- Future product sales of Viaskin Peanut, contingent upon securing regulatory approval, primarily for the U.S. market.
- Potential milestone payments derived from any future licensing or collaboration agreements that may be established.
To be fair, the TTM revenue ending September 30, 2025, was reported at $5.50 million, with the third quarter of 2025 alone contributing $2.77 million in revenue. That quarterly figure represented a significant jump, up 158.77% year-over-year from Q3 2024.
Finance: draft 13-week cash view by Friday.
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