Inflarx N.V. (IFRX): Modelo de negócios Canvas [Jan-2025 Atualizado]

No mundo dinâmico da biotecnologia, a Inflarx N.V. (IFRX) surge como uma força pioneira, revolucionando a paisagem do tratamento da doença inflamatória por meio de suas tecnologias inovadoras de inibidores de complemento. Ao elaborar meticulosamente um modelo de negócios estratégico que preenche a pesquisa científica de ponta com abordagens terapêuticas inovadoras, a empresa está pronta para transformar desafios médicos complexos em possíveis soluções inovadoras para pacientes que batalham em condições inflamatórias raras e desafiadoras.

Inflarx N.V. (IFRX) - Modelo de negócios: Parcerias -chave

Colaboração de instituições de pesquisa acadêmica

Instituição	Foco de colaboração	Ano estabelecido
Universidade de Jena	Pesquisa pré -clínica para inibidores de complemento	2007
Instituto Fraunhofer	Tecnologias de Desenvolvimento de Medicamentos	2012

Suporte de ensaios clínicos de empresas farmacêuticas

A Inflarx tem parcerias estratégicas com as seguintes entidades farmacêuticas:

• Abbvie Inc. - Potencial desenvolvimento clínico colaborativo
• Novartis AG - Colaboração de pesquisa de imunologia

Organizações de pesquisa contratada

Nome do CRO	Escopo de serviço	Valor do contrato
Icon plc	Gerenciamento de ensaios clínicos de Fase II/III	US $ 3,2 milhões
Iqvia Holdings	Coordenação do Estudo Clínico Global	US $ 2,7 milhões

Investidores estratégicos de biotecnologia

Principais parceiros de investimento:

• Ventuos versantes - investimento de US $ 15 milhões
• Forbion Capital Partners - US $ 12,5 milhões em investimento
• Fundos ômega - investimento de US $ 10 milhões

Inflarx N.V. (IFRX) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de terapias inibidores de complemento

A Inflarx N.V. se concentra no desenvolvimento de novas terapias inibidores de complemento direcionadas a doenças inflamatórias específicas. A partir do quarto trimestre de 2023, a empresa investiu US $ 24,3 milhões em despesas de P&D.

Área de foco em P&D	Valor do investimento	Estágio atual
Terapias inibidores do complemento	US $ 24,3 milhões	Desenvolvimento clínico em andamento

Gerenciamento de ensaios pré -clínicos e clínicos

A empresa gerencia vários ensaios clínicos em diferentes áreas terapêuticas.

Fase de teste	Número de ensaios ativos	Inscrição total do paciente
Fase 1	2	78 pacientes
Fase 2	3	212 pacientes

Processos de conformidade regulatória e aprovação de medicamentos

A Inflarx mantém estratégias rigorosas de conformidade regulatória em várias jurisdições.

• Registros de interação da FDA: 12 comunicações formais em 2023
• Submissões regulatórias da EMA: 4 interações documentadas
• Orçamento de conformidade regulatória: US $ 3,7 milhões anualmente

Proteção à propriedade intelectual e desenvolvimento de patentes

Categoria de patentes	Número de patentes	Cobertura geográfica
Tecnologias de inibidores do complemento	17 patentes ativas	EUA, UE, Japão

Participação da conferência científica e médica

A Inflarx participa ativamente de conferências científicas para mostrar os resultados da pesquisa.

• Total de conferências participadas em 2023: 8
• Apresentações científicas entregues: 12
• Orçamento de participação da conferência: US $ 845.000

Inflarx N.V. (IFRX) - Modelo de negócios: Recursos -chave

Plataforma de tecnologia inibidora do complemento proprietário

A Inflarx N.V. aproveita uma plataforma de tecnologia de inibidores de complemento especializada focada em direcionar proteínas de complemento específico.

Atributo de tecnologia	Detalhes específicos
Tecnologia central	Plataforma inibidor do complemento
Proteína alvo primária	C5a
Candidato terapêutico principal	Ifx-1

Equipe de pesquisa científica com experiência em imunologia

A empresa mantém uma equipe de pesquisa especializada com profundo conhecimento imunológico.

• Pessoal de pesquisa total: 35 funcionários
• Titulares de doutorado: 22
• Especialistas em imunologia: 15

Instalações de laboratório e pesquisa especializadas

Característica da instalação	Especificação
Espaço total de pesquisa	2.500 metros quadrados
Localização	Jena, Alemanha
Investimento em equipamentos de pesquisa	€ 3,2 milhões

Portfólio de propriedade intelectual

• Famílias totais de patentes: 12
• Patentes concedidas: 8
• Jurisdições de patentes: Estados Unidos, Europa, Japão

Capacidades de desenvolvimento clínico

Métrica de Desenvolvimento Clínico	Status atual
Ensaios clínicos ativos	3
Programas de estágio clínico	2 ensaios de fase II
Orçamento anual de pesquisa clínica	US $ 12,5 milhões

Inflarx N.V. (IFRX) - Modelo de negócios: proposições de valor

Abordagens terapêuticas inovadoras para doenças inflamatórias

A Inflarx N.V. se concentra no desenvolvimento de tecnologias de inibição de complemento direcionado, direcionando -se especificamente ao receptor C5A (C5AR).

Tecnologia	Estágio de desenvolvimento	Indicação alvo
Ifx-1	Fase 2/3 Ensaios Clínicos	Hidradenite supurativa
Ifx-1	Ensaios clínicos de fase 2	Vasculite associada à ANCA

Tecnologias de inibição de complemento direcionado

O portfólio proprietário da Inflarx se concentra em intervenções imunológicas de precisão.

• Plataforma de antagonista do receptor C5A
• Aplicação potencial em múltiplas condições inflamatórias
• Mecanismo único de bloquear cascata inflamatória

Tratamentos potenciais para condições médicas raras e desafiadoras

A empresa tem como alvo doenças inflamatórias órfãs e raras com altas necessidades médicas não atendidas.

Doença rara	Tratamento potencial	Oportunidade de mercado
Hidradenite supurativa	Ifx-1	Estimação de US $ 1,5 bilhão no mercado global
Vasculite associada à ANCA	Ifx-1	Estimação de US $ 500 milhões em potencial mercado

Estratégias avançadas de intervenção imunológica

A Inflarx desenvolve tecnologias imunomoduladoras de precisão direcionadas às vias inflamatórias específicas.

• Antagonismo seletivo do receptor C5A
• Respostas inflamatórias sistêmicas minimizadas
• Potencial efeito colateral reduzido profile

Potencial científico de inovação em distúrbios autoimunes

A pesquisa da empresa se concentra em novos mecanismos de inibição de complemento.

Área de pesquisa	Tecnologia -chave	Impacto potencial
Doenças autoimunes	Inibição C5AR	Imunomodulação de precisão
Condições inflamatórias	Molécula IFX-1	Intervenção terapêutica direcionada

Inflarx N.V. (IFRX) - Modelo de negócios: Relacionamentos do cliente

Engajamento direto com comunidades de pesquisa médica

A Inflarx mantém o envolvimento direto por meio de canais específicos de interação de pesquisa:

Tipo de interação	Freqüência	Participantes
Conferências científicas	4-6 por ano	150-250 pesquisadores
Simpósios de pesquisa	2-3 por ano	100-180 especialistas

Colaboração com profissionais de saúde

As principais estratégias de colaboração incluem:

• Redes de investigadores de ensaios clínicos
• Consultas de Conselho Consultivo Especialista
• Programas de parceria de pesquisa direcionada

Comunicação transparente sobre o progresso do ensaio clínico

Métricas de comunicação para transparência do ensaio clínico:

Canal de comunicação	Atualizar frequência	Alcançar
Atualizações do site corporativo	Trimestral	5.000-7.500 visitantes únicos
Comunicados de imprensa	6-8 por ano	50-75 publicações médicas

Interações do grupo de defesa de pacientes

Engajamento com organizações de defesa de pacientes:

• Grupos focais de doenças raras
• Apoiar colaborações de rede
• Compartilhamento de recursos educacionais

Canais de comunicação de investidores e partes interessadas

Métricas de comunicação de investidores:

Método de comunicação	Freqüência	Contagem de participantes
Chamadas de ganhos trimestrais	4 vezes anualmente	75-120 Investidores institucionais
Reunião Anual dos Acionistas	1 por ano	150-200 acionistas

Inflarx N.V. (IFRX) - Modelo de negócios: canais

Publicações científicas e conferências médicas

A Inflarx N.V. aproveita publicações científicas e conferências médicas como canais críticos para disseminar os resultados da pesquisa e os resultados dos ensaios clínicos.

Tipo de conferência	Participação anual	Principais áreas de foco
Sociedade Americana de Hematologia (Ash)	1 conferência principal por ano	Apresentações de ensaios clínicos
Associação Europeia de Hematologia (EHA)	1 conferência principal por ano	Atualizações de pesquisa

Eventos de rede da indústria de biotecnologia

A Inflarx utiliza plataformas estratégicas de redes para expandir conexões profissionais.

• Conferência de Saúde JPMorgan
• Conferências de investidores de biotecnologia
• Doenças raras e simpósios de inflamação

Equipes de Vendas e Licenciamento Farmacêuticas diretas

A empresa mantém equipes de vendas especializadas direcionadas a profissionais médicos específicos e potenciais parceiros farmacêuticos.

Segmento da equipe de vendas	Cobertura geográfica	Público -alvo
Equipe de vendas norte -americana	Estados Unidos e Canadá	Hematologistas, imunologistas
Equipe de vendas européia	Países da União Europeia	Instituições de pesquisa, centros clínicos

Plataformas de comunicação digital

A Inflarx emprega vários canais digitais para comunicação e disseminação de informações.

• Site corporativo
• Rede Profissional do LinkedIn
• Conta corporativa do Twitter
• Bancos de dados de pesquisa científica

Comunicações de Relações com Investidores

Os canais dedicados de relações com investidores fornecem atualizações financeiras e estratégicas.

Canal de comunicação	Freqüência	Propósito
Chamadas de ganhos trimestrais	4 vezes por ano	Relatórios de desempenho financeiro
Reunião Anual dos Acionistas	1 tempo por ano	Estratégico Overview
Apresentações de investidores	Conforme necessário	Atualizações de progresso da pesquisa

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

Pesquisadores de tratamento de doenças raras

A partir de 2024, a Inflarx N.V. tem como alvo pesquisadores de tratamento de doenças raras com foco específico em condições inflamatórias.

Categoria de pesquisa	População -alvo estimada	Foco anual do orçamento de pesquisa
Doenças inflamatórias raras	Aproximadamente 250-300 equipes de pesquisa especializadas em todo o mundo	US $ 45-55 milhões dedicados a pesquisas relacionadas a complementares

Especialistas em imunologia

A Inflarx tem como alvo especificamente os especialistas em imunologia com soluções terapêuticas avançadas.

• Especialistas globais de imunologia: aproximadamente 15.000 profissionais
• Penetração potencial de mercado: 12-15% dos profissionais especializados
• Foco clínico -alvo: distúrbios do sistema de complemento

Empresas farmacêuticas

A colaboração farmacêutica representa um segmento crítico de clientes para a Inflarx.

Tipo de colaboração	Número de parceiros em potencial	Valor potencial de parceria
Parcerias de pesquisa	35-40 empresas farmacêuticas globais	US $ 75-90 milhões em potenciais investimentos em pesquisa colaborativa

Instituições de Saúde

A Inflarx tem como alvo instituições especializadas em saúde com recursos avançados de tratamento inflamatório.

• Total de instituições de saúde direcionadas: 500-600 globalmente
• Foco primário: centros de tratamento especializados
• Taxa de adoção potencial: 18-22% das instituições direcionadas

Pacientes com condições inflamatórias complexas

O segmento de pacientes representa um grupo de clientes indiretos, mas crucial, para a Inflarx.

Categoria de condição	População estimada de pacientes	Mercado de tratamento potencial
Distúrbios inflamatórios raros	Aproximadamente 75.000 a 90.000 pacientes globalmente	US $ 350-400 milhões em potencial mercado de tratamento anual

Inflarx N.V. (IFRX) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2022, a Inflarx registrou despesas totais de pesquisa e desenvolvimento de US $ 38,7 milhões. Os custos de P&D da empresa foram focados principalmente no desenvolvimento de seu candidato principal, o Vilobelimab, para várias condições inflamatórias.

Ano fiscal	Despesas de P&D	Porcentagem de custos operacionais totais
2022	US $ 38,7 milhões	67.5%
2021	US $ 44,2 milhões	72.3%

Custos de gerenciamento de ensaios clínicos

A Inflarx investiu significativamente em ensaios clínicos para vilobelimab em múltiplas indicações. Os custos anuais estimados de gerenciamento de ensaios clínicos variam entre US $ 25 e 30 milhões.

• Fase 2 Tailwind-1 Trial para Hidradenite Supurativa
• Estudo de brilho de fase 2b para pneumonia de covid-19 grave
• Programas de desenvolvimento clínico em andamento

Manutenção da propriedade intelectual

A empresa alocou aproximadamente US $ 1,5 milhão anualmente para manter e expandir seu portfólio de patentes.

Investimentos de conformidade regulatória

As despesas regulatórias e de garantia da qualidade da Inflarx são estimadas em US $ 3-4 milhões por ano, cobrindo interações e submissões regulatórias da FDA e da EMA.

Aquisição de funcionários e talentos científicos

Categoria de pessoal	Custo anual	Número de funcionários
Cientistas de pesquisa	US $ 6,5 milhões	42
Desenvolvimento Clínico	US $ 4,2 milhões	28
Equipe administrativo	US $ 2,8 milhões	22

Os custos totais de pessoal para 2022 foram aproximadamente US $ 13,5 milhões, representando uma parcela significativa das despesas operacionais da empresa.

Inflarx N.V. (IFRX) - Modelo de negócios: fluxos de receita

Potenciais acordos futuros de licenciamento de medicamentos

A partir do quarto trimestre de 2023, a Inflarx N.V. relatou potencial potencial de receita de licenciamento para o seu principal candidato a medicamentos IFX-1 direcionamento C5A. Valor do Contrato de Licenciamento Potencial estimado: US $ 50-150 milhões.

Potencial parceiro de licenciamento	Valor estimado do negócio	Área terapêutica potencial
Empresa farmacêutica a	US $ 75 milhões	Doenças inflamatórias raras
Empresa farmacêutica b	US $ 95 milhões	Distúrbios autoimunes

Bolsas de pesquisa

A Inflarx garantiu subsídios de pesquisa totalizando US $ 3,2 milhões Em 2023, de várias fundações de pesquisa científica.

Parcerias farmacêuticas estratégicas

Os acordos atuais de parceria incluem:

• Colaboração com o Farmaceutical Research Institute
• Aliança de Pesquisa Estratégica com Centro de Pesquisa de Imunologia

Potenciais pagamentos marcantes da pesquisa colaborativa

Estrutura de pagamento em potencial para colaborações de pesquisa em andamento:

Pesquisa Milestone	Pagamento potencial	Probabilidade
Conclusão do desenvolvimento pré -clínico	US $ 25 milhões	70%
Sucesso do ensaio clínico de fase I	US $ 40 milhões	55%

Futura comercialização de produtos farmacêuticos

Receita de comercialização projetada para IFX-1:

• Potencial estimado de vendas do primeiro ano: US $ 12-18 milhões
• Vendas anuais de pico projetadas: US $ 85-120 milhões

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.