Inflarx N.V. (IFRX): Business Model Canvas [Jan-2025 Mise à jour]

Dans le monde dynamique de la biotechnologie, Inflarx N.V. (IFRX) émerge comme une force pionnière, révolutionnant le paysage du traitement des maladies inflammatoires grâce à ses technologies d'inhibiteur de complément révolutionnaire. En élaborant méticuleusement un modèle commercial stratégique qui pose des recherches scientifiques de pointe avec des approches thérapeutiques innovantes, l'entreprise est prête à transformer des défis médicaux complexes en solutions de percée potentielles pour les patients luttant contre les conditions inflammatoires rares et difficiles.

Inflarx N.V. (IFRX) - Modèle commercial: partenariats clés

Collaboration des institutions de recherche universitaire

Institution	Focus de la collaboration	Année établie
Université de Jena	Recherche préclinique pour les inhibiteurs du complément	2007
Institut Fraunhofer	Technologies de développement de médicaments	2012

Soutenir les essais cliniques des sociétés pharmaceutiques

Inflarx a des partenariats stratégiques avec les entités pharmaceutiques suivantes:

• AbbVie Inc. - Développement clinique collaboratif potentiel
• Novartis AG - Collaboration de recherche sur l'immunologie

Organisations de recherche contractuelle

Nom de CRO	Portée du service	Valeur du contrat
Icône plc	Gestion des essais cliniques de phase II / III	3,2 millions de dollars
Iqvia Holdings	Coordination mondiale de l'étude clinique	2,7 millions de dollars

Investisseurs stratégiques de biotechnologie

Partners d'investissement majeurs:

• Versant Ventures - Investissement de 15 millions de dollars
• Forbion Capital Partners - 12,5 millions de dollars d'investissement
• Fonds Omega - 10 millions de dollars d'investissement

Inflarx N.V. (IFRX) - Modèle d'entreprise: Activités clés

Recherche et développement de thérapies inhibiteurs du complément

Inflarx N.V. se concentre sur le développement de nouvelles thérapies d'inhibiteurs du complément ciblant des maladies inflammatoires spécifiques. Au quatrième trimestre 2023, la société a investi 24,3 millions de dollars dans les dépenses de R&D.

Zone de focus R&D	Montant d'investissement	Étape actuelle
Thérapies inhibiteurs du complément	24,3 millions de dollars	Développement clinique en cours

Gestion des essais précliniques et cliniques

La société gère plusieurs essais cliniques dans différentes zones thérapeutiques.

Phase de procès	Nombre d'essais actifs	Inscription totale
Phase 1	2	78 patients
Phase 2	3	212 patients

Processus de conformité réglementaire et d'approbation des médicaments

Inflarx maintient des stratégies de conformité réglementaire rigoureuses dans plusieurs juridictions.

• Records d'interaction de la FDA: 12 communications formelles en 2023
• Soumissions réglementaires de l'EMA: 4 interactions documentées
• Budget de conformité réglementaire: 3,7 millions de dollars par an

Protection de la propriété intellectuelle et développement des brevets

Catégorie de brevet	Nombre de brevets	Couverture géographique
Technologies des inhibiteurs du complément	17 brevets actifs	États-Unis, UE, Japon

Participation de la conférence scientifique et médicale

Inflarx participe activement à des conférences scientifiques pour présenter les résultats de la recherche.

• Conférences totales assistées en 2023: 8
• Présentations scientifiques livrées: 12
• Budget de participation de la conférence: 845 000 $

Inflarx N.V. (IFRX) - Modèle d'entreprise: Ressources clés

Plateforme de technologie de l'inhibiteur du complément propriétaire

Inflarx N.V. exploite une plate-forme de technologie spécialisée d'inhibiteur du complément axée sur le ciblage des protéines de complément spécifiques.

Attribut technologique	Détails spécifiques
Technologie de base	Plate-forme d'inhibiteur du complément
Protéine cible primaire	C5A
Candidat thérapeutique à diriger	Ifx-1

Équipe de recherche scientifique avec une expertise en immunologie

La société maintient une équipe de recherche spécialisée avec des connaissances immunologiques profondes.

• Personnel de recherche total: 35 employés
• Tapisseurs de doctorat: 22
• Spécialistes de l'immunologie: 15

Installations spécialisées de laboratoire et de recherche

Caractéristique de l'installation	Spécification
Espace de recherche total	2 500 mètres carrés
Emplacement	Jena, Allemagne
Investissement de l'équipement de recherche	3,2 millions d'euros

Portefeuille de propriété intellectuelle

• Familles totales de brevets: 12
• Brevets accordés: 8
• Juridictions de brevet: États-Unis, Europe, Japon

Capacités de développement clinique

Métrique de développement clinique	État actuel
Essais cliniques actifs	3
Programmes de scène clinique	2 essais de phase II
Budget annuel de recherche clinique	12,5 millions de dollars

Inflarx N.V. (IFRX) - Modèle d'entreprise: propositions de valeur

Approches thérapeutiques innovantes pour les maladies inflammatoires

Inflarx N.V. se concentre sur le développement de technologies d'inhibition du complément ciblées, ciblant spécifiquement le récepteur C5A (C5AR).

Technologie	Étape de développement	Indication cible
Ifx-1	Phase 2/3 essais cliniques	Hidradénite suppurativa
Ifx-1	Essais cliniques de phase 2	Vascularite associée à l'ANCA

Technologies d'inhibition du complément ciblées

Le portefeuille propriétaire d'Inflarx se concentre sur les interventions immunologiques de précision.

• Plate-forme antagoniste des récepteurs C5A
• Application potentielle dans plusieurs conditions inflammatoires
• Mécanisme unique de bloquer la cascade inflammatoire

Traitements potentiels pour des conditions médicales rares et difficiles

L'entreprise cible les maladies inflammatoires orphelines et rares avec des besoins médicaux non satisfaits.

Maladie rare	Traitement potentiel	Opportunité de marché
Hidradénite suppurativa	Ifx-1	Marché mondial estimé à 1,5 milliard de dollars
Vascularite associée à l'ANCA	Ifx-1	Marché potentiel estimé à 500 millions de dollars

Stratégies d'intervention immunologique avancées

Inflarx développe des technologies immunomodulatrices de précision ciblant des voies inflammatoires spécifiques.

• Antagonisme sélectif des récepteurs C5A
• Réponses inflammatoires systémiques minimisées
• Effet secondaire réduit potentiel profile

Potentiel de percée scientifique dans les troubles auto-immunes

Les recherches de l'entreprise se concentrent sur de nouveaux mécanismes d'inhibition du complément.

Domaine de recherche	Technologie clé	Impact potentiel
Maladies auto-immunes	Inhibition C5AR	Immunomodulation de précision
Conditions inflammatoires	Molécule IFX-1	Intervention thérapeutique ciblée

Inflarx N.V. (IFRX) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les communautés de recherche médicale

Inflarx maintient l'engagement direct grâce à des canaux d'interaction de recherche spécifiques:

Type d'interaction	Fréquence	Participants
Conférences scientifiques	4-6 par an	150-250 chercheurs
Symposiums de recherche	2-3 par an	100-180 spécialistes

Collaboration avec des professionnels de la santé

Les stratégies de collaboration clés comprennent:

• Réseaux d'investigateurs d'essais cliniques
• Consultations du conseil consultatif d'experts
• Programmes de partenariat de recherche ciblés

Communication transparente sur les progrès des essais cliniques

Métriques de communication pour la transparence des essais cliniques:

Canal de communication	Mettre à jour la fréquence	Atteindre
Mises à jour du site Web d'entreprise	Trimestriel	5 000 à 7 500 visiteurs uniques
Communiqués de presse	6-8 par an	50-75 publications médicales

Interactions du groupe de défense des patients

Engagement avec les organisations de défense des patients:

• Groupes de discussion sur les maladies rares
• Soutenir les collaborations du réseau
• Partage des ressources éducatives

Canaux de communication des investisseurs et des parties prenantes

Métriques de communication des investisseurs:

Méthode de communication	Fréquence	Comptage des participants
Appels de résultats trimestriels	4 fois par an	75-120 investisseurs institutionnels
Réunion des actionnaires annuelle	1 par an	150-200 actionnaires

Inflarx N.V. (IFRX) - Modèle d'entreprise: canaux

Publications scientifiques et conférences médicales

Inflarx N.V. exploite les publications scientifiques et les conférences médicales comme canaux critiques pour diffuser les résultats de la recherche et les résultats des essais cliniques.

Type de conférence	Participation annuelle	Domaines d'intervention clés
American Society of Hematology (Ash)	1 conférence majeure par an	Présentations des essais cliniques
Association européenne d'hématologie (EHA)	1 conférence majeure par an	Mises à jour de la recherche

Événements de réseautage de l'industrie de la biotechnologie

Inflarx utilise des plates-formes de réseautage stratégiques pour étendre les connexions professionnelles.

• Conférence JPMorgan en matière de santé
• Conférences d'investisseurs en biotechnologie
• Symposiums rares de maladie et d'inflammation

Équipes de vente pharmaceutique directe et de licence

La société maintient des équipes de vente spécialisées ciblant des professionnels de la santé spécifiques et des partenaires pharmaceutiques potentiels.

Segment de l'équipe de vente	Couverture géographique	Public cible
Équipe de vente nord-américaine	États-Unis et Canada	Hématologues, immunologues
Équipe de vente européenne	Pays de l'Union européenne	Institutions de recherche, centres cliniques

Plateformes de communication numérique

Inflarx utilise plusieurs canaux numériques pour la communication et la diffusion de l'information.

• Site Web de l'entreprise
• LinkedIn Professional Network
• Compte d'entreprise Twitter
• Bases de données de recherche scientifique

Communications des relations avec les investisseurs

Les canaux de relations avec les investisseurs dédiés fournissent des mises à jour financières et stratégiques.

Canal de communication	Fréquence	But
Appels de résultats trimestriels	4 fois par an	Rapports de performance financière
Réunion des actionnaires annuelle	1 fois par an	Stratégique Overview
Présentations des investisseurs	Au besoin	Mises à jour des progrès de la recherche

Inflarx N.V. (IFRX) - Modèle d'entreprise: segments de clientèle

Chercheurs en traitement de maladies rares

En 2024, Inflarx N.V. cible les chercheurs en traitement de maladies rares qui se concentrent spécifiquement sur les conditions inflammatoires.

Catégorie de recherche	Population cible estimée	Focus du budget de la recherche annuelle
Maladies inflammatoires rares	Environ 250-300 équipes de recherche spécialisées dans le monde entier	45 à 55 millions de dollars dédiés à la recherche liée au complément

Spécialistes de l'immunologie

Inflarx cible spécifiquement les spécialistes de l'immunologie avec des solutions thérapeutiques avancées.

• Spécialistes mondiaux de l'immunologie: environ 15 000 professionnels
• Pénétration potentielle du marché: 12-15% des praticiens spécialisés
• Cible Focus clinique: les troubles du système de complément

Sociétés pharmaceutiques

La collaboration pharmaceutique représente un segment de clientèle critique pour Inflarx.

Type de collaboration	Nombre de partenaires potentiels	Valeur de partenariat potentiel
Partenariats de recherche	35-40 sociétés pharmaceutiques mondiales	75 à 90 millions de dollars d'investissements potentiels de recherche collaborative

Institutions de soins de santé

Inflarx cible des établissements de santé spécialisés avec des capacités de traitement inflammatoire avancées.

• Institutions totales de soins de santé ciblés: 500-600 dans le monde entier
• Focus primaire: centres de traitement spécialisés
• Taux d'adoption potentiel: 18-22% des institutions ciblées

Patients atteints de conditions inflammatoires complexes

Le segment des patients représente un groupe de clients indirect mais crucial pour Inflarx.

Catégorie d'état	Population estimée des patients	Marché du traitement potentiel
Troubles inflammatoires rares	Environ 75 000 à 90 000 patients dans le monde	350 à 400 millions de dollars sur le marché du traitement annuel potentiel

Inflarx N.V. (IFRX) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2022, Inflarx a déclaré des frais totaux de recherche et de développement de 38,7 millions de dollars. Les coûts de R&D de l'entreprise ont été principalement axés sur le développement de leur candidat principal, Vilobelimab, pour diverses conditions inflammatoires.

Exercice fiscal	Dépenses de R&D	Pourcentage du total des coûts opérationnels
2022	38,7 millions de dollars	67.5%
2021	44,2 millions de dollars	72.3%

Coûts de gestion des essais cliniques

Inflarx a investi considérablement dans des essais cliniques pour le vilobélimab à travers plusieurs indications. Les coûts annuels de gestion des essais cliniques estimés varient entre 25 et 30 millions de dollars.

• Essai de phase 2 du vent-1 pour Hidradénite Suppurativa
• Essai de phase 2b pour la pneumonie sévère Covid-19
• Programmes de développement clinique en cours

Maintenance de la propriété intellectuelle

La société a alloué environ 1,5 million de dollars par an pour maintenir et étendre son portefeuille de brevets.

Investissements de conformité réglementaire

Les dépenses de conformité réglementaire et d'assurance qualité d'Inflarx sont estimées à 3 à 4 millions de dollars par an, couvrant les interactions et les soumissions réglementaires de la FDA et de l'EMA.

Acquisition du personnel et des talents scientifiques

Catégorie de personnel	Coût annuel	Nombre d'employés
Chercheur	6,5 millions de dollars	42
Développement clinique	4,2 millions de dollars	28
Personnel administratif	2,8 millions de dollars	22

Les coûts totaux du personnel pour 2022 étaient approximativement 13,5 millions de dollars, représentant une partie importante des dépenses opérationnelles de l'entreprise.

Inflarx N.V. (IFRX) - Modèle d'entreprise: Strots de revenus

Accords potentiels de licence de médicament potentiel

Depuis le quatrième trimestre 2023, Inflarx N.V. Plage de valeurs de l'accord de licence potentiel estimé: 50 à 150 millions de dollars.

Partenaire de licence potentiel	Valeur estimée de l'accord	Zone thérapeutique potentielle
Compagnie pharmaceutique A	75 millions de dollars	Maladies inflammatoires rares
Compagnie pharmaceutique B	95 millions de dollars	Troubles auto-immunes

Subventions de recherche

Inflarx a obtenu des subventions de recherche totalisant 3,2 millions de dollars en 2023 à partir de diverses fondations de recherche scientifique.

Partenariats pharmaceutiques stratégiques

Les accords de partenariat actuels comprennent:

• Collaboration avec l'Institut de recherche pharmaceutique
• Alliance de recherche stratégique avec le centre de recherche immunologique

Paiements de jalons potentiels de la recherche collaborative

Structure potentielle de paiement des étapes pour les collaborations de recherche en cours:

Jalon de recherche	Paiement potentiel	Probabilité
Achèvement du développement préclinique	25 millions de dollars	70%
Succès de l'essai clinique de phase I	40 millions de dollars	55%

Future commercialisation des produits pharmaceutiques

Revenus de commercialisation projetés pour IFX-1:

• Potentiel de vente de première année estimé: 12 à 18 millions de dollars
• Ventes annuelles de pointe projetées: 85 à 120 millions de dollars

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.