InflaRx N.V. (IFRX) Business Model Canvas

InflaRx N.V. (IFRX): Business Model Canvas

DE | Healthcare | Biotechnology | NASDAQ
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In der dynamischen Welt der Biotechnologie erweist sich InflaRx N.V. (IFRX) als Pionier und revolutioniert die Landschaft der Behandlung entzündlicher Erkrankungen durch seine bahnbrechenden Komplementinhibitor-Technologien. Durch die sorgfältige Ausarbeitung eines strategischen Geschäftsmodells, das modernste wissenschaftliche Forschung mit innovativen Therapieansätzen verbindet, ist das Unternehmen in der Lage, komplexe medizinische Herausforderungen in potenzielle bahnbrechende Lösungen für Patienten zu verwandeln, die mit seltenen und schwierigen Entzündungserkrankungen zu kämpfen haben.


InflaRx N.V. (IFRX) – Geschäftsmodell: Wichtige Partnerschaften

Zusammenarbeit akademischer Forschungseinrichtungen

Institution Fokus auf Zusammenarbeit Gründungsjahr
Universität Jena Präklinische Forschung für Komplementinhibitoren 2007
Fraunhofer-Institut Technologien zur Arzneimittelentwicklung 2012

Unterstützung klinischer Studien durch Pharmaunternehmen

InflaRx unterhält strategische Partnerschaften mit den folgenden Pharmaunternehmen:

  • Abbvie Inc. – Mögliche gemeinsame klinische Entwicklung
  • Novartis AG – Forschungskooperation im Bereich Immunologie

Auftragsforschungsorganisationen

CRO-Name Leistungsumfang Vertragswert
ICON plc Management klinischer Studien der Phasen II/III 3,2 Millionen US-Dollar
IQVIA-Beteiligungen Globale Koordination klinischer Studien 2,7 Millionen US-Dollar

Strategische Biotechnologie-Investoren

Wichtige Investitionspartner:

  • Versant Ventures – 15-Millionen-Dollar-Investition
  • Forbion Capital Partners – 12,5 Millionen US-Dollar Investition
  • Omega Funds – 10-Millionen-Dollar-Investition

InflaRx N.V. (IFRX) – Geschäftsmodell: Hauptaktivitäten

Forschung und Entwicklung von Komplementinhibitor-Therapien

InflaRx N.V. konzentriert sich auf die Entwicklung neuartiger Komplementinhibitor-Therapien zur Behandlung spezifischer entzündlicher Erkrankungen. Bis zum vierten Quartal 2023 hat das Unternehmen 24,3 Millionen US-Dollar in Forschungs- und Entwicklungskosten investiert.

F&E-Schwerpunktbereich Investitionsbetrag Aktuelle Phase
Komplementinhibitor-Therapien 24,3 Millionen US-Dollar Laufende klinische Entwicklung

Präklinisches und klinisches Studienmanagement

Das Unternehmen verwaltet mehrere klinische Studien in verschiedenen Therapiebereichen.

Probephase Anzahl aktiver Versuche Gesamtzahl der Patienteneinschreibungen
Phase 1 2 78 Patienten
Phase 2 3 212 Patienten

Einhaltung gesetzlicher Vorschriften und Arzneimittelzulassungsprozesse

InflaRx verfolgt strenge Strategien zur Einhaltung gesetzlicher Vorschriften in mehreren Gerichtsbarkeiten.

  • Interaktionsaufzeichnungen der FDA: 12 formelle Mitteilungen im Jahr 2023
  • Zulassungsanträge der EMA: 4 dokumentierte Interaktionen
  • Budget für die Einhaltung gesetzlicher Vorschriften: 3,7 Millionen US-Dollar pro Jahr

Schutz des geistigen Eigentums und Patententwicklung

Patentkategorie Anzahl der Patente Geografische Abdeckung
Komplementinhibitor-Technologien 17 aktive Patente USA, EU, Japan

Teilnahme an wissenschaftlichen und medizinischen Konferenzen

InflaRx nimmt aktiv an wissenschaftlichen Konferenzen teil, um Forschungsergebnisse vorzustellen.

  • Gesamtzahl der im Jahr 2023 besuchten Konferenzen: 8
  • Gehaltene wissenschaftliche Vorträge: 12
  • Budget für die Teilnahme an der Konferenz: 845.000 US-Dollar

InflaRx N.V. (IFRX) – Geschäftsmodell: Schlüsselressourcen

Proprietäre Komplementinhibitor-Technologieplattform

InflaRx N.V. nutzt eine spezialisierte Komplementinhibitor-Technologieplattform, die sich auf die gezielte Bekämpfung spezifischer Komplementproteine konzentriert.

Technologieattribut Spezifische Details
Kerntechnologie Komplementinhibitor-Plattform
Primäres Zielprotein C5a
Leitender therapeutischer Kandidat IFX-1

Wissenschaftliches Forschungsteam mit immunologischer Expertise

Das Unternehmen verfügt über ein spezialisiertes Forschungsteam mit umfassenden immunologischen Kenntnissen.

  • Gesamtes Forschungspersonal: 35 Mitarbeiter
  • Doktoranden: 22
  • Immunologiespezialisten: 15

Spezialisierte Labor- und Forschungseinrichtungen

Merkmale der Einrichtung Spezifikation
Gesamter Forschungsraum 2.500 Quadratmeter
Standort Jena, Deutschland
Investitionen in Forschungsausrüstung 3,2 Millionen Euro

Portfolio für geistiges Eigentum

  • Gesamtzahl der Patentfamilien: 12
  • Erteilte Patente: 8
  • Patentgerichte: Vereinigte Staaten, Europa, Japan

Klinische Entwicklungskapazitäten

Klinische Entwicklungsmetrik Aktueller Status
Aktive klinische Studien 3
Programme für die klinische Phase 2 Phase-II-Studien
Jährliches Budget für klinische Forschung 12,5 Millionen US-Dollar

InflaRx N.V. (IFRX) – Geschäftsmodell: Wertversprechen

Innovative Therapieansätze bei entzündlichen Erkrankungen

InflaRx N.V. konzentriert sich auf die Entwicklung gezielter Komplementhemmungstechnologien, die speziell auf den C5a-Rezeptor (C5aR) abzielen.

Technologie Entwicklungsphase Zielanzeige
IFX-1 Klinische Studien der Phasen 2/3 Hidradenitis suppurativa
IFX-1 Klinische Studien der Phase 2 ANCA-assoziierte Vaskulitis

Gezielte Komplementinhibitionstechnologien

Das proprietäre Portfolio von InflaRx konzentriert sich auf präzise immunologische Interventionen.

  • C5a-Rezeptor-Antagonisten-Plattform
  • Mögliche Anwendung bei mehreren entzündlichen Erkrankungen
  • Einzigartiger Mechanismus zur Blockierung der Entzündungskaskade

Mögliche Behandlungsmöglichkeiten für seltene und schwierige Erkrankungen

Das Unternehmen zielt auf seltene und seltene entzündliche Erkrankungen mit hohem ungedecktem medizinischem Bedarf ab.

Seltene Krankheit Mögliche Behandlung Marktchance
Hidradenitis suppurativa IFX-1 Schätzungsweise 1,5 Milliarden US-Dollar globaler Markt
ANCA-assoziierte Vaskulitis IFX-1 Geschätzter potenzieller Markt von 500 Millionen US-Dollar

Fortgeschrittene immunologische Interventionsstrategien

InflaRx entwickelt präzise immunmodulatorische Technologien, die auf bestimmte Entzündungswege abzielen.

  • Selektiver C5a-Rezeptor-Antagonismus
  • Minimierte systemische Entzündungsreaktionen
  • Mögliche geringere Nebenwirkung profile

Wissenschaftliches Durchbruchspotenzial bei Autoimmunerkrankungen

Der Forschungsschwerpunkt des Unternehmens liegt auf neuartigen Mechanismen der Komplementhemmung.

Forschungsbereich Schlüsseltechnologie Mögliche Auswirkungen
Autoimmunerkrankungen C5aR-Hemmung Präzise Immunmodulation
Entzündliche Erkrankungen IFX-1-Molekül Gezielte therapeutische Intervention

InflaRx N.V. (IFRX) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit medizinischen Forschungsgemeinschaften

InflaRx pflegt direktes Engagement über spezifische Forschungsinteraktionskanäle:

Interaktionstyp Häufigkeit Teilnehmer
Wissenschaftliche Konferenzen 4-6 pro Jahr 150-250 Forscher
Forschungssymposien 2-3 pro Jahr 100-180 Spezialisten

Zusammenarbeit mit medizinischem Fachpersonal

Zu den wichtigsten Strategien für die Zusammenarbeit gehören:

  • Netzwerke für klinische Studienforscher
  • Fachbeiratsberatungen
  • Gezielte Forschungspartnerschaftsprogramme

Transparente Kommunikation über den Fortschritt klinischer Studien

Kommunikationskennzahlen für die Transparenz klinischer Studien:

Kommunikationskanal Aktualisierungshäufigkeit Reichweite
Aktualisierungen der Unternehmenswebsite Vierteljährlich 5.000–7.500 einzelne Besucher
Pressemitteilungen 6-8 pro Jahr 50-75 medizinische Veröffentlichungen

Interaktionen mit Patientenvertretungsgruppen

Zusammenarbeit mit Patientenvertretungsorganisationen:

  • Fokusgruppen für seltene Krankheiten
  • Unterstützen Sie Netzwerkkooperationen
  • Teilen von Bildungsressourcen

Kommunikationskanäle für Investoren und Stakeholder

Kennzahlen zur Anlegerkommunikation:

Kommunikationsmethode Häufigkeit Anzahl der Teilnehmer
Vierteljährliche Gewinnmitteilungen 4 mal jährlich 75-120 institutionelle Anleger
Jahreshauptversammlung der Aktionäre 1 pro Jahr 150-200 Aktionäre

InflaRx N.V. (IFRX) – Geschäftsmodell: Kanäle

Wissenschaftliche Veröffentlichungen und medizinische Konferenzen

InflaRx N.V. nutzt wissenschaftliche Veröffentlichungen und medizinische Konferenzen als wichtige Kanäle für die Verbreitung von Forschungsergebnissen und Ergebnissen klinischer Studien.

Konferenztyp Jährliche Teilnahme Schwerpunktbereiche
Amerikanische Gesellschaft für Hämatologie (ASH) 1 große Konferenz pro Jahr Präsentationen zu klinischen Studien
Europäische Vereinigung für Hämatologie (EHA) 1 große Konferenz pro Jahr Forschungsaktualisierungen

Networking-Veranstaltungen für die Biotechnologiebranche

InflaRx nutzt strategische Netzwerkplattformen, um berufliche Verbindungen auszubauen.

  • JPMorgan Healthcare-Konferenz
  • Biotech-Investorenkonferenzen
  • Symposien zu seltenen Krankheiten und Entzündungen

Direkte Vertriebs- und Lizenzierungsteams für Arzneimittel

Das Unternehmen unterhält spezialisierte Vertriebsteams, die sich an bestimmte medizinische Fachkräfte und potenzielle Pharmapartner richten.

Vertriebsteam-Segment Geografische Abdeckung Zielgruppe
Nordamerikanisches Vertriebsteam Vereinigte Staaten und Kanada Hämatologen, Immunologen
Europäisches Vertriebsteam Länder der Europäischen Union Forschungseinrichtungen, klinische Zentren

Digitale Kommunikationsplattformen

InflaRx nutzt mehrere digitale Kanäle für die Kommunikation und Informationsverbreitung.

  • Unternehmenswebsite
  • LinkedIn Professional Network
  • Twitter-Unternehmenskonto
  • Wissenschaftliche Forschungsdatenbanken

Investor-Relations-Kommunikation

Spezielle Investor-Relations-Kanäle bieten finanzielle und strategische Updates.

Kommunikationskanal Häufigkeit Zweck
Vierteljährliche Gewinnaufrufe 4 Mal im Jahr Finanzielle Leistungsberichterstattung
Jahreshauptversammlung 1 Mal pro Jahr Strategisch Overview
Investorenpräsentationen Nach Bedarf Aktualisierungen des Forschungsfortschritts

InflaRx N.V. (IFRX) – Geschäftsmodell: Kundensegmente

Forscher zur Behandlung seltener Krankheiten

Ab 2024 richtet sich InflaRx N.V. an Forscher im Bereich der Behandlung seltener Krankheiten mit besonderem Schwerpunkt auf entzündlichen Erkrankungen.

Forschungskategorie Geschätzte Zielpopulation Jährlicher Fokus auf das Forschungsbudget
Seltene entzündliche Erkrankungen Ungefähr 250–300 spezialisierte Forschungsteams weltweit 45–55 Millionen US-Dollar sind für die komplementbezogene Forschung vorgesehen

Spezialisten für Immunologie

InflaRx richtet sich mit fortschrittlichen therapeutischen Lösungen speziell an Immunologiespezialisten.

  • Globale Immunologie-Spezialisten: Ungefähr 15.000 Fachkräfte
  • Mögliche Marktdurchdringung: 12–15 % der Fachärzte
  • Klinischer Schwerpunkt: Störungen des Komplementsystems

Pharmaunternehmen

Die pharmazeutische Zusammenarbeit stellt für InflaRx ein wichtiges Kundensegment dar.

Art der Zusammenarbeit Anzahl potenzieller Partner Potenzieller Partnerschaftswert
Forschungspartnerschaften 35–40 globale Pharmaunternehmen Mögliche gemeinsame Forschungsinvestitionen in Höhe von 75 bis 90 Millionen US-Dollar

Gesundheitseinrichtungen

InflaRx richtet sich an spezialisierte Gesundheitseinrichtungen mit fortschrittlichen Möglichkeiten zur Behandlung von Entzündungen.

  • Gesamtzahl der anvisierten Gesundheitseinrichtungen: 500–600 weltweit
  • Schwerpunkt: Spezialisierte Behandlungszentren
  • Potenzielle Akzeptanzrate: 18–22 % der Zielinstitutionen

Patienten mit komplexen entzündlichen Erkrankungen

Das Patientensegment stellt eine indirekte, aber entscheidende Kundengruppe für InflaRx dar.

Zustandskategorie Geschätzte Patientenpopulation Potenzieller Behandlungsmarkt
Seltene entzündliche Erkrankungen Ungefähr 75.000–90.000 Patienten weltweit 350–400 Millionen US-Dollar potenzieller jährlicher Behandlungsmarkt

InflaRx N.V. (IFRX) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2022 meldete InflaRx Gesamtkosten für Forschung und Entwicklung in Höhe von 38,7 Millionen US-Dollar. Die Forschungs- und Entwicklungskosten des Unternehmens konzentrierten sich hauptsächlich auf die Entwicklung seines Hauptkandidaten Vilobelimab für verschiedene entzündliche Erkrankungen.

Geschäftsjahr F&E-Ausgaben Prozentsatz der gesamten Betriebskosten
2022 38,7 Millionen US-Dollar 67.5%
2021 44,2 Millionen US-Dollar 72.3%

Kosten für das Management klinischer Studien

InflaRx hat erheblich in klinische Studien für Vilobelimab in mehreren Indikationen investiert. Die geschätzten jährlichen Kosten für die Verwaltung klinischer Studien liegen zwischen 25 und 30 Millionen US-Dollar.

  • Phase-2-TAILWIND-1-Studie für Hidradenitis suppurativa
  • Phase-2b-SHINE-Studie für schwere COVID-19-Pneumonie
  • Laufende klinische Entwicklungsprogramme

Aufrechterhaltung des geistigen Eigentums

Das Unternehmen hat ca. zugeteilt 1,5 Millionen US-Dollar jährlich für den Erhalt und Ausbau seines Patentportfolios.

Investitionen in die Einhaltung gesetzlicher Vorschriften

Die Kosten für die Einhaltung gesetzlicher Vorschriften und die Qualitätssicherung von InflaRx werden auf 3 bis 4 Millionen US-Dollar pro Jahr geschätzt und decken die behördlichen Interaktionen und Einreichungen bei der FDA und EMA ab.

Personal- und wissenschaftliche Talentakquise

Personalkategorie Jährliche Kosten Anzahl der Mitarbeiter
Forschungswissenschaftler 6,5 Millionen Dollar 42
Klinische Entwicklung 4,2 Millionen US-Dollar 28
Verwaltungspersonal 2,8 Millionen US-Dollar 22

Die gesamten Personalkosten für 2022 betrugen ca 13,5 Millionen US-Dollar, was einen erheblichen Teil der Betriebskosten des Unternehmens ausmacht.


InflaRx N.V. (IFRX) – Geschäftsmodell: Einnahmequellen

Mögliche zukünftige Arzneimittellizenzvereinbarungen

Im vierten Quartal 2023 berichtete InflaRx N.V. über potenzielle Lizenzeinnahmen für seinen führenden Medikamentenkandidaten IFX-1, der auf das Komplement C5a abzielt. Geschätzter potenzieller Wert der Lizenzvereinbarung: 50–150 Millionen US-Dollar.

Potenzieller Lizenzpartner Geschätzter Dealwert Möglicher therapeutischer Bereich
Pharmaunternehmen A 75 Millionen Dollar Seltene entzündliche Erkrankungen
Pharmaunternehmen B 95 Millionen Dollar Autoimmunerkrankungen

Forschungsstipendien

InflaRx hat sich Forschungsstipendien in Höhe von insgesamt gesichert 3,2 Millionen US-Dollar im Jahr 2023 von verschiedenen wissenschaftlichen Forschungsstiftungen.

Strategische Pharmapartnerschaften

Zu den aktuellen Partnerschaftsvereinbarungen gehören:

  • Zusammenarbeit mit dem Pharmazeutischen Forschungsinstitut
  • Strategische Forschungsallianz mit dem Immunology Research Center

Potenzielle Meilensteinzahlungen aus Verbundforschung

Mögliche Meilensteinzahlungsstruktur für laufende Forschungskooperationen:

Forschungsmeilenstein Mögliche Zahlung Wahrscheinlichkeit
Abschluss der präklinischen Entwicklung 25 Millionen Dollar 70%
Erfolgreiche klinische Phase-I-Studie 40 Millionen Dollar 55%

Zukünftige Kommerzialisierung pharmazeutischer Produkte

Voraussichtlicher Vermarktungsumsatz für IFX-1:

  • Geschätztes Umsatzpotenzial im ersten Jahr: 12-18 Millionen Dollar
  • Voraussichtlicher Spitzenjahresumsatz: 85-120 Millionen Dollar

InflaRx N.V. (IFRX) - Canvas Business Model: Value Propositions

You're looking at the core value InflaRx N.V. is trying to deliver across its pipeline, which centers on blocking the complement system, a key driver in inflammation. The value propositions are split between an already-approved therapy for a critical, acute condition and a promising oral candidate for chronic diseases.

First-in-class anti-C5a therapy (GOHIBIC) for life-threatening inflammatory conditions.

GOHIBIC (vilobelimab) holds a significant, albeit niche, value proposition as the first and only treatment approved in the European Union for a specific life-threatening condition. This approval was granted by the European Commission on January 15, 2025, under exceptional circumstances.

The value is grounded in clinical benefit data from the Phase 3 PANAMO trial:

  • Reduced 28-day all-cause mortality by 23.9% compared to placebo in the target population.
  • Indicated for adult patients with SARS-CoV-2-induced ARDS receiving systemic corticosteroids and invasive mechanical ventilation (IMV) with or without ECMO.

However, the commercial uptake is currently limited. For the six months ended June 30, 2025, InflaRx N.V. realized only €39 thousand in revenues from GOHIBIC (vilobelimab) sales. The cost structure is heavy, with the company reporting a gross loss of €2,345,945 for the nine months ended September 30, 2025, despite some revenue.

Oral, small-molecule C5aR inhibitor (INF904) with potential best-in-class profile.

INF904 is positioned as a potentially best-in-class oral, small-molecule C5aR1 inhibitor, designed to block C5a-induced signaling and downstream neutrophil activation. This contrasts with a marketed C5aR inhibitor where preclinical data suggested INF904 offered ~3-fold higher Cmax and ~10-fold higher AUClast.

Key data points supporting its profile include:

Parameter Result Context
C5a Blockade ≥90% blockade of C5a-induced neutrophil activation Achieved over a 14-day dosing period in first-in-human studies
CYP3A4/5 Interaction Minimal inhibition A differentiation point versus the marketed C5aR inhibitor
Phase 2a Safety No safety signals of concern reported Across 33 HS patients and 33 CSU patients in the basket trial

The company is planning to advance this asset into Phase 2b development for HS.

Addressing high unmet medical needs in rare and severe inflammatory diseases like HS and CSU.

InflaRx N.V. sees significant market potential in the chronic inflammatory diseases targeted by INF904. The company believes both Hidradenitis Suppurativa (HS) and Chronic Spontaneous Urticaria (CSU) represent potential addressable markets of $1 billion or more each for INF904.

The November 2025 topline data from the Phase 2a trial provided exploratory efficacy signals in these indications:

  • CSU: The 60-mg dose cohort showed the greatest improvement, with a mean absolute reduction in the 7-day Urticaria Activity Score (UAS7) of -13.7 points at week 4.
  • CSU Severe Subgroup: In patients with severe CSU at baseline (n = 23), the 60-mg dose reduced UAS7 by 15.4 points.
  • HS: The 120 mg dose was reported as the most effective in reducing abscesses, nodules, and draining tunnels.

The company is working toward initiating Phase 2b development in HS in 2026.

GOHIBIC's EU marketing authorization for SARS-CoV-2-induced ARDS under exceptional circumstances.

The EU marketing authorization for GOHIBIC (vilobelimab) was granted by the European Commission on January 15, 2025. This authorization is under exceptional circumstances, reflecting the difficulty in obtaining complete data due to the declining phase of the COVID-19 pandemic at the time of authorization.

The authorization is for the treatment of adult patients with SARS-CoV-2-induced ARDS who meet specific criteria:

  • Receiving systemic corticosteroids as part of standard of care.
  • Receiving invasive mechanical ventilation (IMV) with or without extracorporeal membrane oxygenation (ECMO).

The approval obligates InflaRx N.V. to provide annual updates to the EMA on ongoing studies, including the BARDA-funded JUST BREATHE Phase 2 platform study investigating ARDS treatments.

InflaRx N.V. (IFRX) - Canvas Business Model: Customer Relationships

You're managing relationships in a clinical-stage biotech, so the focus is heavily weighted toward scientific credibility and future commercial reach. For InflaRx N.V. (IFRX) as of late 2025, customer relationships center on securing expert validation, establishing distribution channels, and maintaining investor confidence through transparency.

High-touch engagement with key opinion leaders (KOLs) and specialized physicians

Engagement with Key Opinion Leaders (KOLs) is critical for validating clinical progress, especially following the readout of the INF904 Phase 2a trial data, which was discussed on a November 10, 2025, webcast featuring key opinion leader insight. The foundational relationship with the medical community was established through clinical work; for instance, the marketing authorization for GOHIBIC in the EU was supported by the PANAMO study, for which InflaRx N.V. expressed gratitude for the support provided by intensive care physicians who participated. This high-touch approach is necessary to build the foundation for future adoption in indications like hidradenitis suppurativa (HS) and chronic spontaneous urticaria (CSU), where the addressable markets for INF904 are each estimated at $1 billion or more.

The nature of these relationships is demonstrated by the specific events and data points shared with the medical community:

  • Topline data from the Phase 2a clinical trial of INF904 was reported on November 10, 2025.
  • The company is developing vilobelimab (GOHIBIC) and INF904 for rare and severe inflammatory disorders.
  • The company maintains offices in Jena and Munich, Germany, as well as Ann Arbor, MI, USA, supporting a global footprint for collaboration with academic institutions and KOLs across Europe and North America.

Strategic commercial partnering focus for GOHIBIC distribution in the EU

Following the European Commission (EC) granting marketing authorization under exceptional circumstances for GOHIBIC (vilobelimab) in January 2025, the relationship focus shifted to securing commercial distribution. GOHIBIC is the first and only treatment approved in the European Union for SARS-CoV-2-induced ARDS. The authorization covers all 27 EU member states as well as Iceland, Liechtenstein, and Norway. InflaRx N.V. is actively considering commercial partnering and distribution options in the EU, a strategy they noted would not have a materially negative impact on their cash burn rate. This partnering effort is key to scaling access beyond the initial sales, which for the six months ended June 30, 2025, amounted to €39 thousand in revenues from GOHIBIC sales, a decrease of €3 thousand compared to the same period in 2024.

Here's a snapshot of the EU commercial status and partnering strategy as of late 2025:

Metric Value/Status
EU Marketing Authorization Date (GOHIBIC) January 2025
Geographic Coverage 27 EU member states, Iceland, Liechtenstein, and Norway
Distribution Strategy Considering commercial partnering
GOHIBIC Sales (6M Ended June 30, 2025) €39 thousand
Cash Runway Projection Into 2027

Direct, specialized communication with investors via conferences and one-on-one meetings

InflaRx N.V. maintains direct communication with investors, often timed around key data releases. For example, the Q3 2025 financial results and topline data for INF904 were discussed on a webcast on November 10, 2025. The company's investor relations is managed by Jan Medina, CFA Vice President, Head of Investor Relations. The company actively engages through scheduled events, such as in March 2025, when they participated in two investor conferences, both including one-on-one-investor meetings.

Specific investor engagement activities in 2025 included:

  • Participation in Leerink Global Healthcare Conference (March 9 - 12, 2025) with a fireside chat on March 10 at 10:40 AM ET.
  • Participation in H.C. Wainwright 3rd Annual Autoimmune & Inflammatory Disease Virtual Conference on March 27, 2025, with a fireside chat at 8:30 AM ET.
  • Reporting Q1 2025 results on May 7, 2025.
  • Reporting Q2 2025 results on August 7, 2025.

Financially, the company bolstered its position to support these ongoing relationships and development programs by raising gross proceeds of €28.7 million ($30.0 million) in February 2025 through an offering of ordinary shares and pre-funded warrants. This funding helps support operations with a projected cash runway into 2027.

InflaRx N.V. (IFRX) - Canvas Business Model: Channels

You're looking at how InflaRx N.V. gets its product and its message out there as of late 2025. It's a mix of direct engagement where they can control the process and looking for partners where the market is established.

Direct sales to specialized US hospitals for GOHIBIC (vilobelimab)

For GOHIBIC, which holds an Emergency Use Authorization (EUA) in the United States, the channel is direct sales to end customers, meaning hospitals. Sales to distributors don't count as revenue for InflaRx N.V. for reporting purposes. The financial results for the first half of 2025 reflect this direct channel activity.

  • Revenues from GOHIBIC sales in the United States for the six months ended June 30, 2025, totaled €39 thousand.
  • This figure represents a decrease of €3 thousand compared to the same period in 2024.
  • Marketing and sales expenses incurred in the U.S. for the full year 2023 were €4.0 million.

InflaRx N.V. actively encouraged stocking through The InflaRx Commitment Program, which offered to cover the cost of GOHIBIC for eligible patients who died after administration under the EUA in the ICU.

Third-party distributors and commercial partners for EU market access

GOHIBIC received marketing authorization under exceptional circumstances from the European Commission in January 2025. For this market, the strategy is not direct sales but exploring external relationships.

Market Area Commercial Strategy Channel Status/Action as of Late 2025
European Union (EU) Commercial Partnering and Distribution Options InflaRx N.V. continues to pursue these options

The company stated that pursuing this partnering approach is not expected to have a materially negative impact on its cash burn rate.

Global network of clinical trial sites for R&D pipeline advancement

Advancing the pipeline, especially for INF904, relies on a network of clinical sites. This is how InflaRx N.V. gathers the necessary safety, PK, and efficacy data to inform future Phase 2b study designs.

  • The BARDA-funded JUST BREATHE Phase 2 platform clinical trial for ARDS is evaluating vilobelimab and other candidates at up to 60 U.S. sites.
  • The Phase 2a basket study for INF904 in Chronic Spontaneous Urticaria (CSU) and Hidradenitis Suppurativa (HS) involves a total of 75 patients (45 with CSU and 30 with HS) across multiple centers.

Data from this INF904 trial was anticipated by the end of September to early November 2025.

Investor conferences and press releases for capital markets communication

Keeping the capital markets informed is a key channel for a publicly traded company like InflaRx N.V. (Nasdaq: IFRX). This involves direct engagement at industry events and broad communication via press releases.

  • InflaRx N.V. announced participation in two investor conferences in September 2025: the Cantor Global Healthcare Conference (September 3 - 5) and the H.C. Wainwright 27th Annual Global Investment Conference (September 8 - 10).
  • The company also participated in the Guggenheim Securities 2nd Annual Healthcare Innovation Conference in November 2025.
  • Gross proceeds of €28.7 million (or $30.0 million) were subsequently raised via an underwritten public offering of ordinary shares and pre-funded warrants in February 2025.

These communications support the stated cash runway into 2027. Finance: draft 13-week cash view by Friday.

InflaRx N.V. (IFRX) - Canvas Business Model: Customer Segments

You're looking at the specific groups InflaRx N.V. is targeting with its complement-focused pipeline as of late 2025. It's a mix of acute critical care and chronic specialty markets.

Hospitalized adults with SARS-CoV-2-induced ARDS receiving invasive mechanical ventilation (US/EU).

This segment is served by GOHIBIC (vilobelimab), which has European Commission approval for this indication. In the US, enrollment began in the BARDA funded JUST BREATHE Phase 2 platform clinical trial. This trial aims to evaluate candidates at up to 60 U.S. sites, targeting a total enrollment of up to 600 hospitalized adult patients with ARDS.

  • EU Approval: GOHIBIC (vilobelimab) for SARS-CoV-2-induced ARDS on invasive mechanical ventilation.
  • US Trial Enrollment: Started in the BARDA funded JUST BREATHE Phase 2 platform trial.
  • Target Enrollment Size: Up to 600 patients across up to 60 U.S. sites.

Revenues from GOHIBIC sales in the United States for the six months ended June 30, 2025, totaled €39 thousand.

Patients with chronic inflammatory dermatological conditions (Hidradenitis Suppurativa, Chronic Spontaneous Urticaria).

The focus here is on the oral C5aR inhibitor, INF904. The Phase 2a trial involved a total of 75 patients, split between 45 with Chronic Spontaneous Urticaria (CSU) and 30 with Hidradenitis Suppurativa (HS). Data informing Phase 2b planning is expected by year-end 2025.

Indication Product Candidate Estimated Addressable Market (Each)
Chronic Spontaneous Urticaria (CSU) INF904 $1 billion or more
Hidradenitis Suppurativa (HS) INF904 $1 billion or more

Specialized physicians and hospital procurement groups treating severe inflammatory disorders.

These groups are the decision-makers and prescribers for GOHIBIC in the EU and potential future products like INF904. The ARDS trial itself involves up to 60 U.S. sites, indicating a segment of specialized investigators and associated procurement channels. The company's cash position as of June 30, 2025, was €53.7 million, funding operations into 2027.

  • US ARDS Trial Sites: Up to 60 sites involved in the JUST BREATHE trial.
  • Cash Runway: Sufficient funds for currently planned operations into 2027.
  • Market Capitalization: $82.57M as of November 7, 2025.

Global biopharma partners seeking C5a/C5aR assets for co-development.

This segment is represented by existing collaborations and the potential for future deals on pipeline assets. Staidson BioPharmaceuticals is a current partner, advancing the InflaRx-partnered C5a antibody BDB-001, with Phase 3 study initiation expected. InflaRx continues to assess the value of pursuing additional applications via potential future collaborations. The company incurred a net loss of €23.0 million for the six months ended June 30, 2025.

The structure of the partnership with Staidson BioPharmaceuticals involves advancing BDB-001 in ANCA-associated vasculitis (AAV) to a Phase 3 study. The company's revenues for the three months ended September 30, 2025, were €123,819.

InflaRx N.V. (IFRX) - Canvas Business Model: Cost Structure

You're looking at the core expenses that fuel InflaRx N.V.'s engine, which is heavily weighted toward getting its pipeline candidates, especially vilobelimab and INF904, through late-stage development. For a clinical-stage biopharma, the cost structure is almost entirely driven by R&D and the associated overhead to manage those complex trials.

The financial data for the first half of 2025 (H1 2025, six months ended June 30, 2025) shows where the majority of cash burn is occurring. It's a classic profile for a company pushing its lead assets through pivotal studies.

The most dominant cost category is, unsurprisingly, Research and Development (R&D). For H1 2025, InflaRx N.V. reported R&D expenses totaling €14.2 million. This figure reflects the ongoing investment in their clinical programs, though it was noted to have decreased by €3.1 million compared to the same period in 2024.

General and Administrative (G&A) expenses also represent a significant fixed cost base. For the six months ended June 30, 2025, G&A expenses reached €8.3 million. This was an increase of €1.5 million compared to H1 2024.

Here's a quick breakdown of the key components contributing to the operating costs for H1 2025:

Cost Component H1 2025 Amount (€) Comparison Note
Research and Development (R&D) Expenses 14.2 million Decreased by €3.1 million versus H1 2024
General and Administrative (G&A) Expenses 8.3 million Increased by €1.5 million versus H1 2024
Personnel Expenses (Included in G&A/R&D) 4.3 million Reported personnel expenses for the six-month period

Clinical trial and regulatory costs are embedded within the R&D spend. The decrease in R&D was specifically attributed to lower third-party expenses related to clinical material and manufacturing. This suggests that certain large, upfront costs associated with the Phase 3 vilobelimab trial in pyoderma gangrenosum (PG), which was stopped for futility, or earlier manufacturing scale-up activities, were lower in H1 2025 than in H1 2024.

Manufacturing and supply chain costs for vilobelimab production, which relies on partners like WuXi Biologics, are a critical variable cost. While specific external manufacturing fees aren't itemized, the reduction in R&D third-party expenses suggests a favorable shift in these external service provider costs for the period.

Personnel expenses are a major driver of the G&A increase. The reported personnel expenses for H1 2025 were €4.3 million. This increase in headcount or compensation structure is also linked to the G&A rise, alongside higher legal and consulting fees of €2.4 million.

The key cost drivers and their components are:

  • Dominant R&D spend: €14.2 million for H1 2025.
  • G&A expenses: Totaled €8.3 million for H1 2025.
  • Personnel costs: Accounted for €4.3 million of the total expenses.
  • R&D cost reduction driver: Lower third-party expenses for clinical material and related manufacturing.
  • G&A cost driver: Higher legal and consulting expenses of €2.4 million.

Finance: draft 13-week cash view by Friday.

InflaRx N.V. (IFRX) - Canvas Business Model: Revenue Streams

You're looking at the top line for InflaRx N.V. as of late 2025, focusing strictly on where the money is coming from right now. For a clinical-stage company, revenue streams are often a mix of product sales, non-dilutive funding like allowances, and capital raises that keep the lights on while development continues. Here's the quick math on what's flowing in, based on the first half of 2025.

The most direct revenue comes from the commercial product, GOHIBIC (vilobelimab). For the six months ended June 30, 2025, InflaRx N.V. realized €39 thousand in revenues from sales of GOHIBIC, which are attributed to sales in the United States. That's a small figure, honestly, which is typical when a product is newly authorized and the focus remains heavily on pipeline advancement.

Beyond product sales, InflaRx N.V. pulls in income from government incentives. Other income, which is primarily sourced from research allowances, totaled €1.5 million for the six months ended June 30, 2025. This compares to just €53 thousand for the same period in 2024, showing a significant increase in this non-core revenue component.

The company also secures significant, albeit infrequent, cash through equity financing. A major event in early 2025 was the completion of an underwritten public offering in February 2025, which brought in gross proceeds of €28.7 million before accounting for underwriting discounts and expenses. This capital is crucial for funding clinical development, including for vilobelimab and INF904.

Here is a snapshot of these key revenue and cash-inflow components for the first half of 2025:

Revenue/Income Source Amount (H1 2025) Notes
Product Sales (GOHIBIC) €39 thousand Revenues attributed to sales in the United States.
Other Income (Research Allowances) €1.5 million Primarily from research allowances.
Equity Financing (Feb 2025 Offering) €28.7 million (Gross Proceeds) Capital raised to fund pipeline development.

You also have to factor in potential future payments from partnerships. InflaRx N.V. has co-development agreements, like the one involving the partnered C5a antibody BDB-001, which could generate mid-single-digit royalties if successfully commercialized. While these are not current revenue for H1 2025, they represent a key part of the long-term revenue stream model, contingent on clinical success.

To keep things clear, here are the main categories that make up the top-line picture for InflaRx N.V. as of the mid-year point:

  • Product sales of GOHIBIC (vilobelimab), generating €39 thousand in H1 2025.
  • Other income, primarily from research allowances, totaling €1.5 million in H1 2025.
  • Equity financing proceeds, such as the €28.7 million gross proceeds from the February 2025 public offering.
  • Potential future milestone and royalty payments from co-development agreements.

Finance: review the cash runway projection based on the February 2025 financing by next Tuesday.


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