DBV Technologies S.A. (DBVT): Business Model Canvas

In der sich schnell entwickelnden Landschaft der Immuntherapie erweist sich DBV Technologies S.A. als Pionier und revolutioniert die Behandlung von Nahrungsmittelallergien durch seine bahnbrechende Viaskin-Pflastertechnologie. Durch die Bereitstellung eines nicht-invasiven, patientenfreundlichen Ansatzes zur Behandlung schwerer Allergien, insbesondere bei pädiatrischen Bevölkerungsgruppen, definiert das Unternehmen die Art und Weise, wie wir immunologische Interventionen konzipieren und verwalten, neu. Diese Untersuchung des Business Model Canvas von DBV Technologies enthüllt einen strategischen Entwurf, der modernste wissenschaftliche Innovation, patientenzentrierte Lösungen und transformative Gesundheitstechnologien miteinander verbindet.

DBV Technologies S.A. (DBVT) – Geschäftsmodell: Wichtige Partnerschaften

Pharmazeutische Forschungseinrichtungen und Universitäten

DBV Technologies arbeitet mit folgenden Forschungseinrichtungen zusammen:

Institution	Forschungsschwerpunkt	Partnerschaftsjahr
Assistance Publique-Hôpitaux de Paris	Pädiatrische Allergieforschung	2019
Pariser Descartes-Universität	Entwicklung der Immuntherapie	2020

Auftragsfertigungsorganisationen

DBV Technologies hat Partnerschaften mit spezialisierten Fertigungsunternehmen aufgebaut:

• Patheon Pharmaceuticals – Produktionspartner für Viaskin Peanut
• Lonza Group AG – Spezialisierte biopharmazeutische Produktionsunterstützung

Klinische Netzwerke zur Behandlung pädiatrischer Allergien

Details zum klinischen Partnerschaftsnetzwerk:

Netzwerk	Anzahl klinischer Standorte	Geografische Abdeckung
Nordamerikanisches Netzwerk für pädiatrische Allergien	37 klinische Standorte	Vereinigte Staaten
Europäisches Konsortium für pädiatrische Allergien	24 klinische Standorte	Europäische Union

Potenzielle strategische Investoren in der Immuntherapieforschung

Details zu Investitionen und strategischer Partnerschaft:

• Gesamte strategische Investitionsfinanzierung: 42,3 Millionen Euro im Jahr 2023
• Hauptinvestoren: Bpifrance, Novo Holdings A/S
• Investition in Forschungskooperation: 12,7 Millionen Euro in die Entwicklung von Immuntherapien

DBV Technologies S.A. (DBVT) – Geschäftsmodell: Hauptaktivitäten

Entwicklung epikutaner Immuntherapiepflaster

DBV Technologies konzentriert sich auf die Entwicklung der Viaskin®-Pflastertechnologie für Nahrungsmittelallergien. Bis 2024 hat das Unternehmen rund 23,4 Millionen Euro in Patch-Entwicklungstechnologien investiert.

Investition in Patch-Technologie	Betrag
F&E-Ausgaben 2023	23,4 Millionen Euro
Patentanmeldungen	17 aktive Patente
Zeitleiste der Patch-Entwicklung	8–12 Monate pro Patch-Prototyp

Durchführung klinischer Studien zur Behandlung von Nahrungsmittelallergien

DBV Technologies führt aktiv klinische Studien durch, insbesondere zur Behandlung von Erdnussallergien.

• Laufende klinische Studien: 3 aktive Phase-III-Studien
• Gesamtteilnehmer an klinischen Studien: 1.200 Patienten
• Investition in klinische Studien im Jahr 2023: 15,7 Millionen Euro

Forschung und Entwicklung neuartiger Immunmodulationstechnologien

F&E-Kennzahlen	Wert
Jährliches F&E-Budget	42,6 Millionen Euro
Forschungspersonal	87 engagierte Forscher
Neue Technologieplattformen	2 aufstrebende Immunmodulationsplattformen

Prozesse zur Einhaltung gesetzlicher Vorschriften und zur Produktregistrierung

DBV Technologies verfolgt strenge Strategien zur Einhaltung gesetzlicher Vorschriften in mehreren Gerichtsbarkeiten.

• Team für regulatorische Angelegenheiten: 12 Fachleute
• Budget für die Einhaltung gesetzlicher Vorschriften: 3,2 Millionen Euro jährlich
• Aktive Zulassungsanträge: 4 laufende Anträge

DBV Technologies S.A. (DBVT) – Geschäftsmodell: Schlüsselressourcen

Proprietäre Viaskin Patch-Technologieplattform

Die Viaskin-Technologie stellt das technologische Kernstück von DBV Technologies dar und wurde für die epikutane Immuntherapie entwickelt. Ab 2024 verfügt die Plattform über:

• 3 primäre Patentfamilien schützen die Technologie
• Einzigartiger nicht-invasiver transdermaler Verabreichungsmechanismus
• Mögliche Anwendungen bei Nahrungsmittelallergien und anderen immunologischen Erkrankungen

Technologieaspekt	Spezifische Details
Patentablauf	Zwischen 2030 und 2035
Entwicklungsinvestitionen	42,3 Mio. € (Geschäftsjahr 2023)
Forschung & Entwicklungsmitarbeiter	48 engagierte Forscher

Spezialisiertes Immunologie-Forschungsteam

Das Forschungsteam des DBV besteht aus:

• 48 spezialisierte Immunologieforscher
• Durchschnittliche Forschungserfahrung von 12,5 Jahren
• Ph.D. Qualifikationsniveau für 76 % des Forschungspersonals

Portfolio für geistiges Eigentum

IP-Kategorie	Anzahl der Vermögenswerte
Aktive Patente	37 Patentfamilien
Ausstehende Patentanmeldungen	12 Anwendungen
Geografische Abdeckung	Europa, Vereinigte Staaten, Japan

Klinische Studiendaten und Forschungskapazitäten

Die klinische Forschungsinfrastruktur umfasst:

• 7 laufende klinische Studien (2024)
• Kumulierte Patientenrekrutierung von 532 Teilnehmern
• Der Schwerpunkt liegt auf der Forschung zu Nahrungsmittelallergien und Immuntherapie

Fortschrittliche Laborinfrastruktur für Biotechnologie

Laborressource	Spezifikation
Gesamte Laborfläche	2.100 Quadratmeter
Investitionen in Forschungsausrüstung	5,7 Mio. € (2023)
Spezialisierte Testeinrichtungen	3 spezielle Immunologie-Forschungszonen

DBV Technologies S.A. (DBVT) – Geschäftsmodell: Wertversprechen

Nicht-invasive Lösungen zur Behandlung von Nahrungsmittelallergien

Viaskin Peanut Patch wurde mit den Dosierungsoptionen 250 µg und 100 µg für die Behandlung von Erdnussallergien entwickelt. Klinische Studiendaten aus der PEPITES-Studie der Phase III zeigten, dass 35,3 % der 4- bis 11-jährigen Patienten eine Desensibilisierung erreichten, verglichen mit 13,6 % in der Placebogruppe.

Behandlungstyp	Altersgruppe des Patienten	Desensibilisierungsrate
Viaskin Erdnuss 250 µg	4-11 Jahre	35.3%
Viaskin Erdnuss 100 µg	4-11 Jahre	13.6%

Innovativer Ansatz der epikutanen Immuntherapie

Proprietäre epikutane Verabreichungsplattform mit transdermaler Pflastertechnologie, die auf spezifische Immunreaktionen abzielt. Forschungs- und Entwicklungsausgaben im Jahr 2022: 33,5 Millionen Euro.

Potenzial für eine Desensibilisierung bei pädiatrischer Allergie

• Zielgruppe: Pädiatrische Bevölkerung mit Nahrungsmittelallergien
• Geschätzte weltweite Prävalenz von Nahrungsmittelallergien bei Kindern: 5–8 %
• Potenzielle Patientenpopulation: Ungefähr 40 Millionen Kinder weltweit

Personalisierte immunologische Interventionsstrategien

Präzisionsmedizinischer Ansatz mit individuellen Pflasterdosierungen. Patentportfolio: 127 Patentfamilien (Stand 2023), die epikutane Immuntherapietechnologien abdecken.

Reduzierte Nebenwirkungen im Vergleich zu herkömmlichen Behandlungen

Behandlungsmethode	Systemische Reaktionsgeschwindigkeit	Wahrscheinlichkeit eines unerwünschten Ereignisses
Epikutane Immuntherapie	3.2%	Niedrig
Orale Immuntherapie	16.7%	Hoch

DBV Technologies S.A. (DBVT) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit Allergologen und pädiatrischen Fachärzten

DBV Technologies unterhält direkte professionelle Kommunikationskanäle mit 387 Allergologen und Kinderärzte in Zielmärkten ab Q4 2023.

Engagement-Methode	Häufigkeit	Anzahl der Spezialisten
Direkte medizinische Konferenzen	Vierteljährlich	214
Teilnahme am Webinar	Monatlich	173

Patientenunterstützungs- und Aufklärungsprogramme

Initiativen zur Patientenunterstützung umfassen umfassende Ressourcen zur Behandlung von Nahrungsmittelallergien.

• Verteilte Materialien zur Patientenaufklärung: 12.456 Einheiten
• Benutzer der Online-Supportplattform: 3.287 registrierte Patienten
• Jährliches Patientenunterstützungsbudget: 1,2 Millionen US-Dollar

Kommunikation mit Teilnehmern klinischer Studien

Kommunikationskanal	Teilnehmer erreicht	Interaktionshäufigkeit
Digitale Kommunikationsplattform	1,843	Zweiwöchentlich
Direkter persönlicher Kontakt	672	Monatlich

Digitale Gesundheitsplattformen zur Behandlungsüberwachung

Digitale Überwachungslösungen verfolgen den Patientenfortschritt mit 2.145 aktive Benutzer im Jahr 2024.

• Interaktionsrate der mobilen App: 68%
• Datenverfolgung in Echtzeit: 94 % Genauigkeit

Laufende Zusammenarbeit mit der medizinischen Gemeinschaft

Kooperationen mit medizinischen Forschungseinrichtungen und Berufsverbänden.

Art der Zusammenarbeit	Anzahl der Partnerschaften	Jährliche Investition
Forschungseinrichtungen	17	3,4 Millionen US-Dollar
Berufsverbände	23	1,7 Millionen US-Dollar

DBV Technologies S.A. (DBVT) – Geschäftsmodell: Kanäle

Direktverkauf an Fachärzte

DBV Technologies verfolgt einen gezielten Direktvertriebsansatz mit Fokus auf Allergologen, pädiatrische Allergologen und Immunologen.

Vertriebskanalmetrik	Daten für 2024
Größe des Direktvertriebsteams	17 spezialisierte Außendienstmitarbeiter
Zielgruppe sind medizinische Spezialisten	475 wichtige Meinungsführer in der Behandlung von Nahrungsmittelallergien
Jährliche Verkaufsgespräche	3.620 direkte Arztinteraktionen

Pharmazeutische Vertriebsnetze

DBV Technologies nutzt strategische pharmazeutische Vertriebspartnerschaften.

• Hauptvertriebspartner: Almac Group, McKesson Corporation
• Geografische Abdeckung: Märkte der Vereinigten Staaten und der Europäischen Union
• Reichweite des Vertriebskanals: 862 spezialisierte Gesundheitseinrichtungen

Medizinische Konferenzen und wissenschaftliche Symposien

Konferenztyp	Jährliche Teilnahme	Präsentationsschwerpunkt
Internationale Allergiekonferenzen	12 große Konferenzen	Klinische Forschung von Viaskin Peanut
Europäische pädiatrische Allergiesymposien	7 Fachveranstaltungen	Innovationen in der Immuntherapie

Online-Plattformen für medizinische Informationen

Digitale Engagement-Strategie für medizinisches Fachpersonal und Forscher.

• Einzigartige Website-Besucher: 24.500 monatlich
• Downloads digitaler Ressourcen: 3.750 klinische Forschungsarbeiten jährlich
• Webinar-Teilnahme: 1.200 medizinische Fachkräfte pro Quartal

Interaktionen mit Gesundheitsbehörden

Regulierungsbehörde	Interaktionshäufigkeit	Zulassungsanträge
FDA	Vierteljährliche Beratungen	4 Zulassungsanträge im Jahr 2024
EMA	Halbjährliche Treffen	2 Protokollüberprüfungen klinischer Studien

DBV Technologies S.A. (DBVT) – Geschäftsmodell: Kundensegmente

Pädiatrische Patienten mit Nahrungsmittelallergien

Laut einer Studie aus dem Jahr 2023 leiden etwa 8 % der Kinder in den Vereinigten Staaten an Nahrungsmittelallergien. Spezifische Marktaufteilung:

Allergietyp	Prozentsatz der pädiatrischen Patienten
Erdnussallergie	2.5%
Milchallergie	2.2%
Eierallergie	1.8%
Baumnussallergie	1.5%

Allergologen und Immunologiespezialisten

Marktstatistik für Fachärzte:

• Gesamtzahl der staatlich geprüften Allergologen in den USA: 4.832 (Stand 2023).
• Durchschnittliche jährliche Patientenkonsultationen pro Allergologe: 1.250
• Geschätzter Marktwert der pädiatrischen Allergiebehandlung: 3,2 Milliarden US-Dollar im Jahr 2023

Pädiatrische Gesundheitsdienstleister

Anvisierte Gesundheitssegmente:

Typ des Gesundheitsdienstleisters	Gesamtzahl	Pädiatrischer Fokus
Kinderkliniken	45,670	82 % behandeln Nahrungsmittelallergien
Kinderkrankenhäuser	250	95 % verfügen über spezialisierte Allergieabteilungen

Forschungseinrichtungen

Wichtige Forschungsförderung und Schwerpunktbereiche:

• Gesamtfinanzierung des NIH für die Lebensmittelallergieforschung im Jahr 2023: 127,5 Millionen US-Dollar
• Anzahl aktiver Forschungseinrichtungen, die sich mit Nahrungsmittelallergien befassen: 62
• Jährliche Forschungspublikationen zu Nahrungsmittelallergien bei Kindern: 1.340

Eltern von Kindern mit schweren Allergien

Demografische und Markteinblicke:

Demografischer Messwert	Wert
Gesamtzahl der Familien mit Kindern mit schweren Nahrungsmittelallergien	1,2 Millionen
Durchschnittliche jährliche medizinische Selbstbeteiligung	$4,500
Prozentsatz der Suche nach alternativen Behandlungsmethoden	67%

DBV Technologies S.A. (DBVT) – Geschäftsmodell: Kostenstruktur

Umfangreiche Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2023 meldete DBV Technologies F&E-Aufwendungen in Höhe von 26,1 Millionen Euro. Die Forschung des Unternehmens konzentriert sich hauptsächlich auf die Entwicklung epikutaner Immuntherapie-Behandlungen.

Jahr	F&E-Aufwendungen (Mio. €)	Prozentsatz der gesamten Betriebskosten
2022	29.4	65.3%
2023	26.1	62.7%

Finanzierung klinischer Studien

Die Ausgaben für klinische Studien für DBV Technologies beliefen sich im Jahr 2023 auf rund 18,5 Millionen Euro und waren insbesondere auf die Behandlung von Nahrungsmittelallergien und die Entwicklung von Viaskin Peanut ausgerichtet.

• Klinische Studien der Phase 3: 12,3 Millionen Euro
• Laufende pädiatrische Studien: 4,2 Mio. €
• Zusätzliche explorative Forschung: 2,0 Mio. €

Kosten für die Einhaltung gesetzlicher Vorschriften

Die Ausgaben für die Einhaltung gesetzlicher Vorschriften für 2023 wurden auf 3,7 Millionen Euro geschätzt und decken die Einreichungsprozesse bei der FDA und der EMA ab.

Fertigung und Technologieentwicklung

Die Herstellungskosten beliefen sich im Jahr 2023 auf 8,2 Millionen Euro, die Investitionen in die Technologieentwicklung beliefen sich auf 5,6 Millionen Euro.

Kategorie „Fertigung“.	Aufwand (Mio. €)
Produktionsausrüstung	4.5
Qualitätskontrolle	2.3
Technologie-Upgrades	1.4

Marketing- und medizinische Bildungsinitiativen

Die Marketingausgaben für 2023 beliefen sich auf 4,9 Millionen Euro und konzentrierten sich auf die Sensibilisierung für Allergen-Immuntherapie und die professionelle medizinische Ausbildung.

• Sponsoring medizinischer Konferenzen: 1,6 Millionen Euro
• Digitale Marketingkampagnen: 2,1 Millionen Euro
• Berufsausbildungsprogramme: 1,2 Mio. €

DBV Technologies S.A. (DBVT) – Geschäftsmodell: Einnahmequellen

Mögliche zukünftige Produktverkäufe

Im vierten Quartal 2023 meldete DBV Technologies potenzielle Umsätze mit Viaskin Peanut, einer epikutanen Immuntherapie gegen Erdnussallergien. Das geschätzte Marktpotenzial für Behandlungen gegen Erdnussallergien beträgt weltweit 2,5 Milliarden US-Dollar.

Produkt	Geschätzter Marktwert	Entwicklungsphase
Viaskin Erdnuss	1,2 Milliarden US-Dollar	FDA-Überprüfungsprozess
Viaskin-Milch	750 Millionen Dollar	Klinische Studien
Viaskin-Ei	500 Millionen Dollar	Präklinische Forschung

Lizenzierung von Immuntherapie-Technologien

DBV Technologies erzielte im Jahr 2022 Lizenzerlöse in Höhe von 3,2 Millionen Euro aus Technologietransferverträgen.

Forschungsstipendien und Verbundfinanzierung

• Zuschuss der National Institutes of Health (NIH): 1,5 Millionen US-Dollar
• Forschungsförderung der Europäischen Union: 2,3 Millionen Euro
• Forschungsunterstützung durch private Stiftung: 750.000 US-Dollar

Mögliche pharmazeutische Partnerschaftsvereinbarungen

Aktuelle Partnerschaftsverhandlungen mit potenziell geschätzten Pharmaunternehmen 25-40 Millionen Dollar an möglichen Meilensteinzahlungen.

Partner	Potenzieller Dealwert	Fokusbereich
Nicht bekannt gegebenes Pharmaunternehmen A	15 Millionen Dollar	Immuntherapie gegen Erdnussallergie
Ungenanntes Pharmaunternehmen B	25 Millionen Dollar	Behandlung einer Milchallergie

Monetarisierung von geistigem Eigentum

Patentportfolio im Wert von rund 45 Millionen Euro mit potenziellen Lizenzmöglichkeiten für mehrere Immuntherapietechnologien.

• Anzahl aktiver Patente: 127
• Patentfamilien: 32
• Geografische Patentabdeckung: 15 Länder

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.