InflaRx N.V. (IFRX): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el mundo dinámico de la biotecnología, Inflarx N.V. (IFRX) emerge como una fuerza pionera, revolucionando el paisaje del tratamiento de la enfermedad inflamatoria a través de sus innovadoras tecnologías inhibidores del complemento. Al crear meticulosamente un modelo de negocio estratégico que une la investigación científica de vanguardia con enfoques terapéuticos innovadores, la compañía está a punto de transformar desafíos médicos complejos en posibles soluciones innovadoras para pacientes que luchan contra afecciones inflamatorias raras y desafiantes.

Inflarx N.V. (IFRX) - Modelo de negocio: asociaciones clave

Instituciones de investigación académica colaboración

Institución	Enfoque de colaboración	Año establecido
Universidad de Jena	Investigación preclínica para inhibidores del complemento	2007
Instituto Fraunhofer	Tecnologías de desarrollo de fármacos	2012

Soporte de ensayos clínicos de compañías farmacéuticas

Inflarx tiene asociaciones estratégicas con las siguientes entidades farmacéuticas:

• Abbvie Inc. - Desarrollo clínico colaborativo potencial
• Novartis AG - Colaboración de investigación de inmunología

Organizaciones de investigación por contrato

Nombre de Cro	Alcance del servicio	Valor de contrato
Ícono plc	Gestión de ensayos clínicos de fase II/III	$ 3.2 millones
Iqvia Holdings	Coordinación del estudio clínico global	$ 2.7 millones

Inversores de biotecnología estratégica

Principales socios de inversión:

• Versant Ventures - Inversión de $ 15 millones
• Forbion Capital Partners - $ 12.5 millones de inversión
• Fondos Omega - Inversión de $ 10 millones

Inflarx N.V. (IFRX) - Modelo de negocio: actividades clave

Investigación y desarrollo de terapias con inhibidores del complemento

Inflarx N.V. se centra en el desarrollo de nuevas terapias inhibidor del complemento dirigido a enfermedades inflamatorias específicas. A partir del cuarto trimestre de 2023, la compañía ha invertido $ 24.3 millones en gastos de I + D.

Área de enfoque de I + D	Monto de la inversión	Etapa actual
Terapias inhibidor de complemento	$ 24.3 millones	Desarrollo clínico en curso

Gestión de ensayos preclínicos y clínicos

La compañía administra múltiples ensayos clínicos en diferentes áreas terapéuticas.

Fase de prueba	Número de pruebas activas	Inscripción total del paciente
Fase 1	2	78 pacientes
Fase 2	3	212 pacientes

Cumplimiento regulatorio y procesos de aprobación de medicamentos

Inflarx mantiene estrategias de cumplimiento regulatorias rigurosas en múltiples jurisdicciones.

• Registros de interacción de la FDA: 12 comunicaciones formales en 2023
• Envíos regulatorios de EMA: 4 interacciones documentadas
• Presupuesto de cumplimiento regulatorio: $ 3.7 millones anuales

Protección de propiedad intelectual y desarrollo de patentes

Categoría de patente	Número de patentes	Cobertura geográfica
Tecnologías de inhibidores de complemento	17 patentes activas	EE. UU., EU, Japón

Participación de la conferencia científica y médica

Inflarx participa activamente en conferencias científicas para mostrar los resultados de la investigación.

• Conferencias totales asistidas en 2023: 8
• Presentaciones científicas entregadas: 12
• Presupuesto de participación de la conferencia: $ 845,000

Inflarx N.V. (IFRX) - Modelo de negocio: recursos clave

Plataforma de tecnología de inhibidores del complemento patentado

Inflarx N.V. aprovecha una plataforma de tecnología de inhibidores de complemento especializada centrada en dirigirse a proteínas específicas del complemento.

Atributo tecnológico	Detalles específicos
Tecnología central	Plataforma de inhibidores de complemento
Proteína objetivo primaria	C5A
Candidato terapéutico	IFX-1

Equipo de investigación científica con experiencia en inmunología

La compañía mantiene un equipo de investigación especializado con un profundo conocimiento inmunológico.

• Personal de investigación total: 35 empleados
• Titulares de doctorado: 22
• Especialistas de inmunología: 15

Laboratorio e instalaciones de investigación especializadas

Característica de la instalación	Especificación
Espacio total de investigación	2.500 metros cuadrados
Ubicación	Jena, Alemania
Inversión en equipos de investigación	3.2 millones de euros

Cartera de propiedades intelectuales

• Familias de patentes totales: 12
• Patentes concedidas: 8
• Jurisdicciones de patentes: Estados Unidos, Europa, Japón

Capacidades de desarrollo clínico

Métrico de desarrollo clínico	Estado actual
Ensayos clínicos activos	3
Programas de estadio clínico	2 pruebas de fase II
Presupuesto anual de investigación clínica	$ 12.5 millones

Inflarx N.V. (IFRX) - Modelo de negocio: propuestas de valor

Enfoques terapéuticos innovadores para enfermedades inflamatorias

Inflarx N.V. se centra en el desarrollo de tecnologías de inhibición del complemento dirigido, dirigido específicamente al receptor C5A (C5AR).

Tecnología	Etapa de desarrollo	Indicación objetivo
IFX-1	Fase 2/3 ensayos clínicos	Hidradenitis supurativa
IFX-1	Ensayos clínicos de fase 2	Vasculitis asociada a ANCA

Tecnologías de inhibición del complemento dirigido

La cartera patentada de Inflarx se centra en las intervenciones inmunológicas de precisión.

• Plataforma antagonista del receptor C5A
• Aplicación potencial en múltiples condiciones inflamatorias
• Mecanismo único para bloquear la cascada inflamatoria

Tratamientos potenciales para afecciones médicas raras y desafiantes

La compañía se dirige a enfermedades inflamatorias huérfanas y raras con altas necesidades médicas no satisfechas.

Enfermedad rara	Tratamiento potencial	Oportunidad de mercado
Hidradenitis supurativa	IFX-1	Mercado global estimado de $ 1.5 mil millones
Vasculitis asociada a ANCA	IFX-1	Mercado potencial estimado de $ 500 millones

Estrategias avanzadas de intervención inmunológica

Inflarx desarrolla tecnologías inmunomoduladoras de precisión dirigidas a vías inflamatorias específicas.

• Antagonismo selectivo del receptor C5a
• Respuestas inflamatorias sistémicas minimizadas
• Efecto secundario reducido potencial profile

Potencial de avance científico en trastornos autoinmunes

La investigación de la compañía se centra en nuevos mecanismos de inhibición del complemento.

Área de investigación	Tecnología clave	Impacto potencial
Enfermedades autoinmunes	Inhibición de C5AR	Inmunomodulación de precisión
Condiciones inflamatorias	Molécula IFX-1	Intervención terapéutica dirigida

Inflarx N.V. (IFRX) - Modelo de negocio: relaciones con los clientes

Compromiso directo con las comunidades de investigación médica

Inflarx mantiene la participación directa a través de canales de interacción de investigación específicos:

Tipo de interacción	Frecuencia	Participantes
Conferencias científicas	4-6 por año	150-250 investigadores
Simposios de investigación	2-3 por año	100-180 especialistas

Colaboración con profesionales de la salud

Las estrategias de colaboración clave incluyen:

• Redes de investigadores de ensayos clínicos
• Consultas de la Junta Asesora de Expertos
• Programas de asociación de investigación específicas

Comunicación transparente sobre el progreso del ensayo clínico

Métricas de comunicación para la transparencia del ensayo clínico:

Canal de comunicación	Actualización de frecuencia	Alcanzar
Actualizaciones del sitio web corporativo	Trimestral	5,000-7,500 visitantes únicos
Comunicados de prensa	6-8 por año	50-75 publicaciones médicas

Interacciones del grupo de defensa del paciente

Compromiso con organizaciones de defensa del paciente:

• Grupos focales de enfermedades raras
• Soporte de colaboraciones de redes
• Intercambio de recursos educativos

Canales de comunicación de inversores y partes interesadas

Métricas de comunicación de inversores:

Método de comunicación	Frecuencia	Recuento de participantes
Llamadas de ganancias trimestrales	4 veces anualmente	75-120 inversores institucionales
Reunión anual de accionistas	1 por año	150-200 accionistas

Inflarx N.V. (IFRX) - Modelo de negocio: canales

Publicaciones científicas y conferencias médicas

Inflarx N.V. aprovecha las publicaciones científicas y las conferencias médicas como canales críticos para difundir los hallazgos de la investigación y los resultados de los ensayos clínicos.

Tipo de conferencia	Participación anual	Áreas de enfoque clave
Sociedad Americana de Hematología (Ash)	1 conferencia importante por año	Presentaciones de ensayos clínicos
Asociación Europea de Hematología (EHA)	1 conferencia importante por año	Actualizaciones de investigaciones

Eventos de redes de la industria de biotecnología

Inflarx utiliza plataformas estratégicas de redes para expandir las conexiones profesionales.

• Conferencia de atención médica JPMorgan
• Conferencias de inversores de biotecnología
• Simposios de enfermedades y inflamación raras

Equipos directos de ventas farmacéuticas y licencias

La compañía mantiene equipos de ventas especializados dirigidos a profesionales médicos específicos y posibles socios farmacéuticos.

Segmento del equipo de ventas	Cobertura geográfica	Público objetivo
Equipo de ventas de América del Norte	Estados Unidos y Canadá	Hematólogos, inmunólogos
Equipo de ventas europeo	Países de la Unión Europea	Instituciones de investigación, centros clínicos

Plataformas de comunicación digital

Inflarx emplea múltiples canales digitales para la comunicación y la difusión de información.

• Sitio web corporativo
• Red profesional de LinkedIn
• Cuenta corporativa de Twitter
• Bases de datos de investigación científica

Comunicaciones de relaciones con los inversores

Los canales dedicados de relaciones con los inversores proporcionan actualizaciones financieras y estratégicas.

Canal de comunicación	Frecuencia	Objetivo
Llamadas de ganancias trimestrales	4 veces al año	Informes de desempeño financiero
Reunión anual de accionistas	1 vez por año	Estratégico Overview
Presentaciones de inversores	Según sea necesario	Actualizaciones de progreso de la investigación

Inflarx N.V. (IFRX) - Modelo de negocio: segmentos de clientes

Investigadores de tratamiento de enfermedades raras

A partir de 2024, Inflarx N.V. se dirige a los investigadores de tratamiento de enfermedades raras con enfoque específico en afecciones inflamatorias.

Categoría de investigación	Población objetivo estimada	Enfoque de presupuesto de investigación anual
Enfermedades inflamatorias raras	Aproximadamente 250-300 equipos de investigación especializados a nivel mundial	$ 45-55 millones dedicado a la investigación relacionada con el complemento

Especialistas en inmunología

Inflarx se dirige específicamente a especialistas en inmunología con soluciones terapéuticas avanzadas.

• Especialistas en inmunología global: aproximadamente 15,000 profesionales
• Penetración potencial del mercado: 12-15% de profesionales especializados
• Enfoque clínico objetivo: trastornos del sistema de complemento

Compañías farmacéuticas

La colaboración farmacéutica representa un segmento crítico de clientes para inflaro.

Tipo de colaboración	Número de socios potenciales	Valor de asociación potencial
Asociaciones de investigación	35-40 compañías farmacéuticas globales	$ 75-90 millones de posibles inversiones de investigación colaborativa

Instituciones de atención médica

Inflarx se dirige a instituciones de salud especializadas con capacidades avanzadas de tratamiento inflamatorio.

• Instituciones de atención médica totales dirigidas: 500-600 a nivel mundial
• Enfoque primario: centros de tratamiento especializados
• Tasa de adopción potencial: 18-22% de las instituciones dirigidas

Pacientes con afecciones inflamatorias complejas

El segmento de pacientes representa un grupo de clientes indirecto pero crucial para inflaro.

Categoría de condición	Población de pacientes estimada	Mercado potencial de tratamiento
Trastornos inflamatorios raros	Aproximadamente 75,000-90,000 pacientes a nivel mundial	$ 350-400 millones Mercado de tratamiento anual potencial

Inflarx N.V. (IFRX) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2022, Inflarx reportó gastos totales de investigación y desarrollo de $ 38.7 millones. Los costos de I + D de la compañía se han centrado principalmente en desarrollar su candidato principal, Vilobelimab, para diversas afecciones inflamatorias.

Año fiscal	Gastos de I + D	Porcentaje de costos operativos totales
2022	$ 38.7 millones	67.5%
2021	$ 44.2 millones	72.3%

Costos de gestión de ensayos clínicos

Inflarx ha invertido significativamente en ensayos clínicos para vilobelimab en múltiples indicaciones. Los costos estimados de gestión de ensayos clínicos anuales oscilan entre $ 25-30 millones.

• Ensayo de viento de cola de fase 2 para la hidradenitis supurativa
• Ensayo de brillo de fase 2b para neumonía severa Covid-19
• Programas de desarrollo clínico en curso

Mantenimiento de la propiedad intelectual

La compañía ha asignado aproximadamente $ 1.5 millones anuales para mantener y expandir su cartera de patentes.

Inversiones de cumplimiento regulatorio

Los gastos de cumplimiento regulatorio y garantía de calidad de Inflarx se estiman en $ 3-4 millones por año, cubriendo las interacciones y presentaciones regulatorias de la FDA y EMA.

Adquisición de personal y talento científico

Categoría de personal	Costo anual	Número de empleados
Investigar científicos	$ 6.5 millones	42
Desarrollo clínico	$ 4.2 millones	28
Personal administrativo	$ 2.8 millones	22

Los costos totales de personal para 2022 fueron aproximadamente $ 13.5 millones, que representa una parte significativa de los gastos operativos de la Compañía.

Inflarx N.V. (IFRX) - Modelo de negocio: flujos de ingresos

Acuerdos potenciales de licencia de medicamentos futuros

A partir del cuarto trimestre de 2023, Inflarx N.V. informó un potencial de ingresos por licencias para su candidato principal candidato al fármaco IFX-1 para el complemento C5A. Rango de valor de acuerdo de licencia potencial estimado: $ 50-150 millones.

Posente de licencia potencial	Valor de acuerdo estimado	Área terapéutica potencial
Compañía farmacéutica A	$ 75 millones	Enfermedades inflamatorias raras
Compañía farmacéutica B	$ 95 millones	Trastornos autoinmunes

Subvenciones de investigación

Inflarx ha obtenido subvenciones de investigación en total $ 3.2 millones en 2023 de varias bases de investigación científica.

Asociaciones farmacéuticas estratégicas

Los acuerdos de asociación actuales incluyen:

• Colaboración con el Instituto de Investigación Farmacéutica
• Alianza de Investigación Estratégica del Centro de Investigación de Inmunología

Pagos potenciales de hitos de la investigación colaborativa

Estructura de pago de hito potencial para colaboraciones de investigación en curso:

Hito de investigación	Pago potencial	Probabilidad
Finalización del desarrollo preclínico	$ 25 millones	70%
Fase I éxito del ensayo clínico	$ 40 millones	55%

Futura comercialización de productos farmacéuticos

Ingresos de comercialización proyectados para IFX-1:

• Potencial de ventas de primer año estimado: $ 12-18 millones
• Ventas anuales máximas proyectadas: $ 85-120 millones

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.