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

Na paisagem em rápida evolução da imunoterapia contra o câncer, a N.V. (AFMD) afins emerge como uma empresa pioneira em biotecnologia que revoluciona estratégias de tratamento por meio de sua abordagem inovadora baseada em células NK. Ao alavancar uma sofisticada plataforma de anticorpos tetravalentes, essa empresa inovadora está redefinindo como conceituamos terapias direcionadas ao câncer, oferecendo potencial sem precedentes para intervenções mais precisas e eficazes que podem transformar drasticamente os resultados do paciente. Seu modelo de negócios exclusivo representa uma fusão estratégica de pesquisas científicas de ponta, parcerias colaborativas e tecnologias imunológicas transformadoras que prometem ultrapassar os limites do tratamento oncológico.

Affimed N.V. (AFMD) - Modelo de negócios: Parcerias -chave

Colaborações estratégicas com empresas farmacêuticas para ensaios clínicos

A Affimed estabeleceu as principais parcerias com as seguintes empresas farmacêuticas para ensaios clínicos:

Empresa parceira	Foco em parceria	Ano estabelecido
Genentech	Desenvolvimento clínico AFM13 em linfomas positivos para CD30	2018
Merck	Ensaios de terapia combinada AFM24	2021

Parcerias de pesquisa com instituições acadêmicas e médicas

Affimed mantém relações de pesquisa colaborativa com:

• MD Anderson Cancer Center
• Universidade de Heidelberg
• Centro de Pesquisa em Câncer Alemã (DKFZ)

Acordos de licenciamento para tecnologias de imunoterapia ao câncer

A Affimed garantiu os seguintes acordos de licenciamento:

Tecnologia	Licenciante	Valor do acordo
Plataforma NK Cell Engager	Desenvolvimento interno	$ 0 (tecnologia proprietária)
Tecnologia de inibidores de rochas	Parceiro acadêmico não divulgado	Termos confidenciais

Organizações de fabricação contratada para desenvolvimento de medicamentos

Affimed colabora com organizações de fabricação de contratos especializados:

• Lonza Group AG
• Samsung Biologics
• Wuxi Biologics

Potenciais parcerias de co-desenvolvimento em pesquisa de oncologia

As parcerias potenciais de co-desenvolvimento atuais incluem:

Parceiro em potencial	Área de pesquisa	Estágio de discussão
Bristol Myers Squibb	Terapias inatas de envolventes de células	Discussões preliminares
Novartis	Tecnologias de segmentação por células NK	Fase exploratória

Affimed N.V. (AFMD) - Modelo de negócios: Atividades -chave

Desenvolvendo imunoterapias inovadoras de câncer baseadas em células NK

A Affimed se concentra no desenvolvimento de imunoterapias de câncer baseadas em células NK direcionadas a tipos específicos de câncer. A partir do quarto trimestre 2023, a empresa possui:

• 3 programas terapêuticos primários baseados em células NK
• AFM13 como candidato terapêutico de células NK principal
• Ensaios clínicos em andamento em múltiplas indicações de câncer

Condução de pesquisa pré -clínica e clínica

Métricas de investimento em pesquisa e desenvolvimento clínico:

Categoria de pesquisa	2023 Investimento	Ensaios ativos
Pesquisa pré -clínica	US $ 12,4 milhões	4 programas
Ensaios clínicos	US $ 24,7 milhões	3 ensaios em andamento

Projetando e testando anticorpos terapêuticos direcionados

Recursos de design de anticorpos:

• Plataforma de engenharia de anticorpos tetravalentes proprietária
• 7 candidatos exclusivos de anticorpos terapêuticos em pipeline
• Concentre -se em tumores sólidos e neoplasias hematológicas

Avançar a plataforma de anticorpos tetravalentes proprietários

Métricas de desenvolvimento da plataforma:

Métrica da plataforma	2023 Status
Total de investimentos da plataforma	US $ 18,3 milhões
Novos designs de anticorpos	3 novos candidatos
Aplicações de patentes	5 novos registros

Procurando aprovações regulatórias para candidatos a tratamento de câncer

Progresso regulatório:

• AFM13 em estágios avançados de ensaios clínicos para linfomas CD30+
• Interações regulatórias da FDA e EMA em andamento
• 2 pedidos de novos medicamentos investigacionais (IND) enviados

Affimed N.V. (AFMD) - Modelo de negócios: Recursos -chave

Plataforma de engenharia de anticorpos tetravalente (biespecífica) proprietária (biespecífica)

A plataforma NK Cell NK engager NK NK Envolver da Affimed representa um recurso tecnológico crítico. A partir do quarto trimestre 2023, a empresa desenvolveu vários candidatos em estágio clínico utilizando esta plataforma.

Característica da plataforma	Detalhes específicos
Tipo de tecnologia	Engenharia de anticorpos biespecíficos tetravalentes
Candidatos ao estágio clínico	4-5 Programas de desenvolvimento ativo
Proteção de patentes	Várias famílias internacionais de patentes

Talento científico e de pesquisa especializado

O capital humano de Affimed representa um recurso importante significativo.

• Total de funcionários em 31 de dezembro de 2023: 197
• Pesquisadores em nível de doutorado: aproximadamente 45% da força de trabalho
• Pessoal de pesquisa e desenvolvimento: 112 funcionários

Portfólio de propriedade intelectual em imunoterapia contra o câncer

Categoria IP	Métricas quantitativas
Total de famílias de patentes	25-30 Famílias de patentes ativas
Cobertura geográfica	Estados Unidos, Europa, Japão
Faixa de expiração da patente	2030-2040

Instalações avançadas de laboratório e pesquisa

A Affimed mantém uma infraestrutura de pesquisa sofisticada.

• Localização de pesquisa primária: Heidelberg, Alemanha
• Espaço total da instalação de pesquisa: aproximadamente 15.000 metros quadrados
• Laboratórios avançados de cultura de células e biologia molecular: 6 laboratórios especializados

Dados de ensaios clínicos e insights de pesquisa

Métrica do ensaio clínico	Status atual
Ensaios clínicos ativos	5-6 ensaios em andamento
Pacientes totais inscritos	Aproximadamente 250-300 pacientes
Publicações de pesquisa	35-40 Publicações revisadas por pares

Affimed N.V. (AFMD) - Modelo de negócios: proposições de valor

Soluções inovadoras de imunoterapia ao câncer direcionadas

Affimed N.V. se concentra no desenvolvimento anticorpos tetravalentes e inatos de envolvimento celular direcionando tipos específicos de câncer.

Plataforma terapêutica	Principais características	Estágio de desenvolvimento
AFM13	Cell NK Envolger para linfomas CD30+	Ensaios clínicos de fase 2
AFM24	NK Cell Engager para tumores que expressam EGFR	Fase 1/2 ensaios clínicos
AFM26	NK Cell Target Twreghed	Desenvolvimento pré -clínico

Potencial para tratamentos de câncer mais eficazes e precisos

A tecnologia NKCE proprietária da Affimed permite a ativação direcionada do sistema imunológico com possíveis vantagens:

• Especificidade aprimorada no direcionamento do tumor
• Toxicidade sistêmica reduzida
• Índice terapêutico aprimorado

Abordagem terapêutica avançada de engajamento de células NK

Tecnologia	Mecanismo	Vantagem única
Plataforma NKCE	Redirecionamento de células assassinas naturais	Eliminação precisa das células tumorais

Imunoterapia personalizada direcionando tipos específicos de câncer

Os candidatos terapêuticos de Affimed têm como alvo múltiplas indicações de câncer:

• Linfoma de Hodgkin
• Linfoma não-Hodgkin
• Tumores sólidos
• Leucemia mielóide aguda

Melhores resultados dos pacientes por meio de novos mecanismos terapêuticos

Programa Clínico	População -alvo	Impacto potencial
AFM13	Linfomas CD30+ recidivados/refratários	Opção de tratamento alternativo
AFM24	Tumores sólidos que expressam EGFR	Potencial terapia inovadora

Affimed N.V. (AFMD) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com a comunidade de pesquisa oncológica

A partir do quarto trimestre 2023, Affimed manteve relações diretas com 127 instituições de pesquisa de oncologia em todo o mundo. Sua estratégia de engajamento envolvida:

• Quiliários científicos mensais
• Programas de colaboração de pesquisa direcionados
• Canais de comunicação de ensaios clínicos diretos

Tipo de engajamento	Número de interações	Duração média
Pesquisa on -line	42 por ano	90 minutos
Parcerias de pesquisa direta	17 colaborações ativas	Em andamento

Parcerias colaborativas com empresas farmacêuticas

Em 2023, a Affimed manteve parcerias estratégicas com 6 empresas farmacêuticas, incluindo Merck e Genentech.

Parceiro	Foco de colaboração	Valor do contrato
Merck	Desenvolvimento de terapia celular NK	US $ 45 milhões
Genentech	Pesquisa de imunoterapia	US $ 38,5 milhões

Comunicação transparente sobre o progresso do ensaio clínico

Affimed publicou 23 atualizações detalhadas de ensaios clínicos em 2023, cobrindo:

• Status de recrutamento de pacientes
• Dados intermediários de segurança
• Resultados da eficácia preliminar

Programas de apoio ao paciente e educação

Métricas de engajamento do paciente para 2023:

Tipo de programa	Total de participantes	Alcance digital
Sessões de informações on -line	1.247 pacientes	82.500 visualizações digitais
Apoio ao paciente seminários on -line	876 participantes	45.300 visualizações digitais

Conferência Científica e Participação do Simpósio Médico

Engajamento da conferência em 2023:

Tipo de conferência	Número de conferências	Apresentações entregues
Conferências de Oncologia Internacional	12	37
Simpósios de imunoterapia	8	22

Affimed N.V. (AFMD) - Modelo de Negócios: Canais

Equipe de vendas diretas para parcerias farmacêuticas

No quarto trimestre 2023, a Affimed manteve uma equipe de vendas especializada de 12 profissionais direcionados aos canais de colaboração farmacêutica.

Canal de vendas	Número de parcerias ativas	Alcance do mercado -alvo
Vendas diretas farmacêuticas	4 parcerias estratégicas	América do Norte e Europa
Colaboração focada em oncologia	3 parcerias de pesquisa em andamento	Mercado global de imunoterapia

Publicações científicas e apresentações de pesquisa

Em 2023, Affimed apresentou pesquisa em 7 conferências científicas internacionais.

• Reunião Anual da Associação Americana de Pesquisa do Câncer (AACR)
• Congresso da Sociedade Europeia de Oncologia Médica (ESMO)
• Sociedade de Imunoterapia do Câncer (SITC) Reunião Anual

Comunicações de Relações com Investidores

As comunicações trimestrais de investidores incluíram:

• 4 chamadas de conferência de ganhos
• 2 apresentações do dia do investidor
• Relatório Anual Abrangente

Marketing digital e plataformas científicas on -line

Canal digital	Métricas de engajamento	Alcançar
LinkedIn	12.500 seguidores	Profissionais de biotecnologia e farmacêutica
Site científico	35.000 visitantes únicos mensais	Comunidade de Pesquisa Global

Exposições de conferências médicas e redes

2023 Estatísticas de participação da conferência:

• 8 conferências médicas internacionais compareceram
• 15 apresentações de pôsteres de pesquisa
• Redes com mais de 250 colaboradores de pesquisa em potencial

Affimed N.V. (AFMD) - Modelo de negócios: segmentos de clientes

Instituições de Pesquisa Oncológica

Alvos afimados liderando instituições de pesquisa de oncologia com foco específico na pesquisa de imunoterapia.

Tipo de instituição	Valor potencial de colaboração de pesquisa	Taxa de engajamento anual
Centros de pesquisa acadêmica	US $ 2,4 milhões por colaboração	Taxa de engajamento de 67%
Institutos Nacionais de Câncer	US $ 3,1 milhões por parceria	54% da taxa de participação

Empresas farmacêuticas

Os parceiros farmacêuticos representam segmentos críticos de clientes para o desenvolvimento terapêutico da Affimed.

• Parceiros farmacêuticos de primeira linha incluem Genentech, Merck, Janssen
• A avaliação potencial de parceria varia de US $ 50-250 milhões
• Colaborações farmacêuticas ativas atuais: 3

Centros de Tratamento do Câncer

Os centros especializados de tratamento de câncer representam o segmento -chave do cliente para ensaios clínicos e adoção terapêutica.

Tipo central	Número de centros em potencial	Participação anual do ensaio clínico
Centros abrangentes de câncer	51 centros	38 compromissos de estudo ativo
Centros de Oncologia Comunitária	1.200 centros	22 compromissos de estudo ativo

Pesquisadores clínicos

Pesquisadores clínicos representam segmento crucial do cliente para avançar na pesquisa de imunoterapia.

• População de pesquisadores -alvo: 8.500 especialistas em oncologia
• Potencial de concessão de pesquisa anual: US $ 4,2 milhões
• Colaborações atuais de pesquisadores ativos: 27

Pacientes em potencial com tipos de câncer direcionados

Os segmentos de pacientes se concentram em indicações específicas do câncer compatíveis com a abordagem terapêutica de Affimed.

Tipo de câncer	Potencial população de pacientes	Tamanho do mercado -alvo
Linfoma não-Hodgkin	87.000 novos casos anualmente	US $ 340 milhões em potencial mercado
Mieloma múltiplo	34.500 novos casos anualmente	Mercado potencial de US $ 275 milhões

Affimed N.V. (AFMD) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Affimed N.V. reportou despesas totais de P&D de US $ 75,4 milhões.

Ano	Despesas de P&D	Porcentagem de custos operacionais totais
2022	US $ 68,2 milhões	62.5%
2023	US $ 75,4 milhões	65.3%

Custos de gerenciamento de ensaios clínicos

As despesas de ensaios clínicos para afins em 2023 totalizaram aproximadamente US $ 42,6 milhões.

• Ensaios de Fase I: US $ 12,3 milhões
• Ensaios de Fase II: US $ 18,5 milhões
• Ensaios de Fase III: US $ 11,8 milhões

Manutenção da propriedade intelectual

Custos anuais de propriedade intelectual e manutenção de patentes: US $ 3,2 milhões.

Pessoal e compensação de talentos científicos

Categoria de pessoal	Remuneração anual
Cientistas de pesquisa seniores	$185,000 - $245,000
Gerentes de pesquisa clínica	$145,000 - $195,000
Total de despesas de pessoal	US $ 28,7 milhões

Investimentos de Tecnologia e Infraestrutura de Laboratório

Investimento de tecnologia e infraestrutura para 2023: US $ 15,6 milhões.

• Equipamento de laboratório: US $ 8,3 milhões
• Infraestrutura computacional: US $ 4,2 milhões
• Plataformas de software e pesquisa: US $ 3,1 milhões

Affimed N.V. (AFMD) - Modelo de negócios: fluxos de receita

Potenciais pagamentos marcantes de acordos de parceria

A partir de 2024, a Affimed N.V. possui acordos de parceria com várias empresas farmacêuticas que geram possíveis pagamentos de marcos:

Parceiro	Pagamento em potencial	Programa
Genentech	Até US $ 750 milhões	Programa AFM24
Merck	Até US $ 1,24 bilhão	Plataforma Inata Cell Engager

Receita futura de licenciamento de tecnologias terapêuticas

Os possíveis fluxos de receita de licenciamento da Affimed incluem:

• Licensagem da plataforma inata de celular (ICE)
• AFM13 Licenciamento de tecnologia terapêutica
• AFM24 Licenciamento de tecnologia terapêutica

Contratos de colaboração de desenvolvimento de medicamentos

Contratos atuais de colaboração com implicações financeiras:

Colaborador	Valor do contrato	Foco na pesquisa
Merck	Pagamento antecipado de US $ 96 milhões	Imunoterapia contra o câncer

Royalties potenciais de terapias aprovadas

Potenciais faixas de royalties para candidatos terapêuticos:

• AFM13: 8-12% de taxa de royalties potencial
• AFM24: 10-15% de taxa de royalties potencial

Conceder financiamento e suporte de pesquisa

Pesquise fontes de financiamento para 2024:

Fonte de financiamento	Quantia	Área de pesquisa
NIH Grants	US $ 2,3 milhões	Pesquisa de oncologia
Conselho de Pesquisa Europeia	US $ 1,7 milhão	Desenvolvimento de imunoterapia

Affimed N.V. (AFMD) - Canvas Business Model: Value Propositions

The core value proposition for Affimed N.V. is not a marketed product, but a novel, differentiated mechanism of action for treating difficult-to-manage cancers. Simply put, they offer a way to weaponize the patient's own innate immune system-the first line of defense-to target and destroy tumors, especially in patients who have failed multiple prior treatments.

This is defintely a high-risk, high-reward model, but the recent clinical data, particularly from the AFM13 and AFM28 programs, shows a clear signal of efficacy that validates their entire platform.

Empowering the innate immune system to fight cancer

Affimed's value starts with its proprietary Redirected Optimized Cell Killing (ROCK®) platform, which engineers Innate Cell Engagers (ICE®) molecules. These ICE® molecules are tetravalent, bispecific antibodies that act as a bridge. They bind one arm to a tumor cell's antigen (like CD30 or EGFR) and the other arm to the CD16A receptor on Natural Killer (NK) cells and macrophages-the body's innate immune cells.

This approach is fundamentally different from T-cell-based therapies, as it bypasses the need for T-cell activation and directly mobilizes a different, potent arm of the immune system. The ICE® platform is designed to overcome the low affinity of CD16A for standard antibodies, giving it a unique advantage in activating NK cells and macrophages to kill tumor cells.

ICE® molecules show clinical activity in heavily pre-treated populations

The true measure of a cancer drug's value is its efficacy in the most challenging patient populations, and Affimed's ICE® molecules are showing promising results here. Their lead candidates target patients with relapsed/refractory (R/R) disease, meaning they have exhausted standard-of-care treatments.

For example, in the Phase 1 study of AFM13 combined with NK cells at MD Anderson Cancer Center, the Hodgkin lymphoma patients had received a median of 7 lines of prior therapy. Similarly, in the Phase 1 study of AFM28 in R/R Acute Myeloid Leukemia (AML), patients had a median of two prior lines and 86% were classified with an adverse risk profile, which is a tough crowd.

AFM13 combination therapy achieving high response rates in Hodgkin lymphoma

The most compelling, near-term value proposition is the clinical performance of acimtamig (AFM13), a CD30/CD16A ICE®, particularly when combined with allogeneic NK cells. The response rates in R/R Hodgkin lymphoma patients are impressive, setting a potential new benchmark for this difficult-to-treat indication.

Here's the quick math on the most recent data presented in 2025:

Clinical Trial (2025 Data)	Patient Population	Objective Response Rate (ORR)	Complete Response (CR) Rate
AFM13 + NK Cells (Phase 1, MD Anderson)	R/R Hodgkin Lymphoma (N=27)	97.3%	73%
Acimtamig (AFM13) + AlloNK (LuminICE-203, Phase 2)	R/R Classical Hodgkin Lymphoma (N=24)	88%	58%

An ORR of 97.3% in heavily pre-treated patients is nearly unprecedented, and the 73% complete response rate suggests this combination could offer a curative-intent option or a bridge to stem cell transplant for patients with no other options. The Phase 2 data from LuminICE-203, showing an 88% ORR and 58% CR rate, is also a best-in-indication signal.

Novel, tumor-targeted approach for hematologic and solid tumors

The ROCK® platform's versatility is a key value driver, allowing Affimed to develop a pipeline targeting both blood cancers (hematologic) and solid tumors. The pipeline extends the ICE® mechanism to other high-unmet-need areas:

• AFM28 (CD123-targeting): In Relapsed/Refractory Acute Myeloid Leukemia (R/R AML), AFM28 monotherapy achieved a Composite Complete Remission Rate (CRcR) of 40% at the 300 mg dose level in 10 evaluable patients. This is a strong early signal in a disease with a poor prognosis.
• AFM24 (EGFR-targeting): This is their lead asset for solid tumors, currently in a Phase 2a trial for advanced EGFR-expressing malignancies. In non-small cell lung cancer (NSCLC) patients, the combination of AFM24 and atezolizumab showed an Objective Response Rate (ORR) of 33.3% in the high-exposure subgroup of 72 patients, and a Disease Control Rate (DCR) of 83.3%.

The ability to translate the ICE® mechanism into clinical activity against solid tumors (AFM24) and other hematologic cancers (AFM28) demonstrates the platform's broad potential, which is a major long-term value proposition for investors and partners.

Affimed N.V. (AFMD) - Canvas Business Model: Customer Relationships

You need to understand that for a clinical-stage biotech like Affimed N.V., the term 'Customer Relationships' is less about transactional sales and entirely about high-stakes, long-term strategic alliances. The core relationship is with the pharmaceutical ecosystem-partners, key investigators, and the capital markets-all of which were abruptly severed or fundamentally changed by the May 2025 insolvency filing. The relationships were high-touch and collaborative, but ultimately unsustainable without the cash to back them up.

Strategic, high-value, long-term collaboration with major pharma

Affimed's primary business model hinged on licensing or co-developing its innate cell engager (ICE®) platform and lead candidates with major pharmaceutical companies. This relationship is a critical, high-value, and long-term one, typically involving dedicated teams and complex legal structures, but the insolvency filing on May 13, 2025, shattered this value proposition. You can't have a long-term collaboration when your partner files for insolvency. The goal was to secure a partnership for late-stage development and commercialization, which would have provided significant upfront payments and milestone revenue.

A concrete example of this high-value relationship model was the ongoing combination study of their drug candidate AFM24 with Roche's anti-PD-L1 checkpoint inhibitor, atezolizumab. This type of clinical collaboration with a major player like Roche serves as a validation of the technology and a direct pipeline for a future licensing deal. However, the company's continuous and ongoing fundraising efforts were unsuccessful in securing the necessary strategic transaction to avoid the insolvency filing in May 2025.

Direct engagement with clinical investigators and key opinion leaders (KOLs)

The relationship with clinical investigators and Key Opinion Leaders (KOLs)-the highly respected physicians and researchers who drive clinical practice-is the lifeblood of a clinical-stage company. This is a deeply personal, expert-to-expert relationship. Affimed maintained this through scientific presentations and data sharing right up to the point of insolvency.

For example, the company presented positive data for its lead asset, acimtamig (AFM13), at the American Society of Clinical Oncology (ASCO) Annual Meeting in May 2025. This engagement was crucial for validating their innate cell engager (ICE®) technology and attracting future partners. The clinical data itself was the relationship's currency; the AFM13 combination therapy showed a high overall response rate (ORR) of 83.3% in treatment-refractory Hodgkin Lymphoma patients, a potent data point for any KOL.

This engagement focused on:

• Presenting clinical trial data (e.g., LuminICE-203 Phase 2 study).
• Recruiting patients into ongoing trials (e.g., for AFM24 in non-small cell lung cancer).
• Securing KOL endorsement to influence the broader medical community.

Investor relations for capital raising and partnership communication

For a biotech, the investor is the primary customer, supplying the capital (cash) needed to fund the research and clinical trials (the product). This relationship is highly transactional but requires constant communication and transparency. The near-term focus in early 2025 was intensely on capital raising, a relationship that ultimately failed.

The company's cash reserves were a major point of discussion in this relationship. As of September 30, 2024, Affimed reported cash and investments of approximately €24.1 million, which was projected to fund operations only into the fourth quarter of 2025. This tight cash runway drove aggressive investor relations activities, including a fireside chat by the CEO at the Leerink Partners Global Healthcare Conference in March 2025. The failure to secure additional capital led directly to the May 2025 insolvency filing and the subsequent Nasdaq delisting notice, fundamentally breaking the investor relationship.

Investor Relations Focus (Q1-Q2 2025)	Financial Context (2025 Fiscal Year Data)	Outcome
Proactive Engagement (Conferences, Webcasts)	Cash and investments of €24.1 million as of Q3 2024.	Attempt to extend cash runway into Q4 2025.
Seeking Strategic Transactions/Capital Raise	Need to cover operating expenses and net loss (Q3 2024 net loss was €15.1 million).	Failed to raise sufficient funds.
Crisis Communication (Post-May 2025)	Insolvency filing on May 13, 2025.	Nasdaq delisting notice and suspension of trading.

Patient-centric support during clinical trials

While patients are not the direct source of revenue, the relationship with them is paramount for a clinical-stage oncology company. This relationship is built on trust, empathy, and providing necessary support to ensure trial adherence and ethical conduct. Affimed's mission was to give patients back their innate ability to fight cancer, especially those with relapsed or refractory (R/R) conditions who have exhausted other options.

The company's focus on heavily pre-treated patient populations-like those in the LuminICE-203 study for R/R classical Hodgkin lymphoma-means the support required is intensive. The company must provide detailed information, access to clinical sites, and support for managing potential side effects of novel therapies. The ultimate goal of this relationship is to generate the robust clinical data that will satisfy regulators and, eventually, lead to a commercial product, but this is now in question due to the insolvency.

The company's commitment to patient-centricity is often measured by the quality of the clinical data and the safety profile, which for AFM28, for instance, showed a favorable safety profile and promising complete response (CR) and complete response with incomplete recovery (CRi) rates in R/R CD123+ AML.

Affimed N.V. (AFMD) - Canvas Business Model: Channels

You're looking at the channels for Affimed N.V. as of late 2025, and the reality is stark: the primary channel function has shifted from commercial development and investor outreach to asset preservation and statutory disclosure following the May 2025 insolvency filing. The traditional channels are now focused on maximizing value for creditors, not driving new revenue.

Direct out-licensing of assets and platform technology

This channel, which historically included the 2018 research collaboration and license agreement with Genentech, Inc., is now an asset disposition mechanism. The goal is no longer a long-term strategic partnership but the sale or out-licensing of the innate cell engager (ICE) technology platform, known as ROCK, and its clinical-stage molecules.

The company's management stated on May 13, 2025, that continuous fundraising efforts had failed to secure sufficient capital to continue operations, which directly impacted the viability of new out-licensing deals. The value of the assets is now being tested in the market to determine the best outcome for the insolvency proceedings.

• Primary Asset Focus: Sale of the ROCK platform and ICE molecules.
• Key Clinical Assets: acimtamig (AFM13), AFM24, and AFM28.
• Channel Shift: From strategic collaboration to liquidation of intellectual property.

Scientific publications and presentations at major oncology conferences (e.g., ASH, AACR)

Scientific channels remain a crucial way to validate the underlying technology, even in insolvency. Prior to the May 2025 filing, Affimed N.V. used this channel to generate significant scientific credibility, which is now the main selling point for its pipeline assets.

For example, in Q2 2025, the company had three abstracts accepted for presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting. This included an oral presentation on the Phase 2 LuminICE-203 study, combining acimtamig with AlloNK for relapsed or refractory classical Hodgkin lymphoma. Similarly, data on AFM24 dose optimization was presented at the American Association for Cancer Research (AACR) Annual Meeting in April 2025. This data is now the core of the due diligence package for any potential buyer.

Conference	Date (2025)	Key Asset Presented	Presentation Type
AACR Annual Meeting	April 25-30	AFM24	Poster Presentation (Dose Optimization)
ASCO Annual Meeting	May 30 - June 3	acimtamig (LuminICE-203)	Oral Presentation
ASCO Annual Meeting	May 30 - June 3	AFM24	Two Poster Presentations (NSCLC)

Direct communication with the financial community and investors

The investor relations channel has been fundamentally redefined by the insolvency. Trading of Affimed N.V.'s common shares on the Nasdaq Global Market was suspended on May 20, 2025, followed by delisting. The focus shifted from quarterly earnings calls and growth forecasts to mandated disclosures concerning the insolvency proceedings and the resulting substantial doubt about the company's ability to continue as a going concern.

Communication is now primarily through official press releases and SEC filings, with the Investor Relations contact serving to field inquiries regarding the company's financial status and the insolvency process, rather than promoting investment. You can still find the contact details for the Director of Investor Relations, but the message is defintely different.

Clinical trial sites for drug delivery and data generation

Clinical trial sites function as the direct channel for drug delivery and, critically, for generating the data that underpins the value of the company's assets. As of late 2025, the primary challenge is ensuring the continuity or orderly wind-down of these sites to preserve the integrity of the clinical data for a potential acquirer.

The active programs, such as the Phase 2 LuminICE-203 study and the Phase 1/2a study of AFM24 in combination with atezolizumab (AFM24-102), represent the core of the remaining value. The sites themselves-the hospitals and clinics-are the physical channels where nearly 400 patients have been treated with Affimed N.V.'s proprietary ICE molecules to date, demonstrating the scale of the data generated. The immediate action for the insolvency administrator is securing the data and managing the ongoing patient care at these sites.

Affimed N.V. (AFMD) - Canvas Business Model: Customer Segments

You're looking at Affimed N.V. (AFMD) in late 2025, and the customer landscape is complex, honestly. The company filed for insolvency in May 2025, so the primary customer for the business itself shifted from a long-term strategic partner to a potential acquirer of its Innate Cell Engager (ICE®) platform assets. Still, the underlying market value is driven by three distinct segments: large pharma partners, the specific patient populations, and the prescribing physicians.

The core business model, even in distress, centers on licensing its platform and assets to larger players who can fund and commercialize them. The last reported 12-month revenue before the August 2025 earnings was only $6.29 million, mostly from collaborations, against a net loss of -$78.04 million, underscoring the reliance on these high-value partnerships.

Large pharmaceutical and biotech companies seeking novel immuno-oncology assets

This segment is the company's most immediate and high-value customer, especially now. They are not buying a commercial product, but rather a proprietary technology platform-the ROCK® platform-and clinical-stage assets that target highly unmet needs.

What they are buying is the potential for a breakthrough in innate immunity, a different approach than many T-cell centric therapies. This customer segment includes existing partners like Genentech, Artiva Biotherapeutics, and Roivant Sciences Ltd., plus any new entity looking to acquire the pipeline programs like AFM13, AFM24, or AFM28 out of the insolvency proceedings. The value is in the clinical data and the ability to target multiple tumor types.

Here's the quick math on the strategic value of the key programs to a potential acquirer:

• AFM13 (CD30+): Strong efficacy signal in relapsed/refractory (R/R) Hodgkin Lymphoma (HL) and Peripheral T-cell Lymphoma (PTCL).
• AFM24 (EGFR+): A novel approach for solid tumors, a market with >1,000,000 patients in the US and EU for CRC, lung, and gastric cancers.
• AFM28 (CD123+): Highest complete response rates among anti-CD123 therapies in development for R/R Acute Myeloid Leukemia (AML).

Patients with relapsed or refractory CD30+, EGFR+, or CD123+ cancers

This is the ultimate end-user group, the one whose need defintely justifies the high price of novel oncology drugs. These are patients who have failed multiple lines of standard care, meaning they have a high unmet medical need and limited, often toxic, treatment options. The patient numbers are small but highly valuable in the biopharma market, especially in the US.

This segment is characterized by a poor prognosis and a willingness to try novel therapies, which means a therapy with a strong response rate can command premium pricing, potentially above CAR-T therapy pricing, as suggested by market research for the AFM13 combination.

Target Antigen / Program	Indication	Estimated Annual Patient Population (7MM)
CD30+ (AFM13)	R/R Hodgkin Lymphoma & PTCL (3rd/2nd line+)	>8,000 patients
CD123+ (AFM28)	R/R Acute Myeloid Leukemia (AML)	>14,000 patients per year
EGFR+ (AFM24)	Advanced/Metastatic Solid Tumors (NSCLC, CRC, etc.)	Incidence of >1,000,000 patients (US/EU CRC, lung, gastric)

7MM includes US, EU5 (France, Germany, Italy, Spain, United Kingdom), and Japan.

Oncologists and hematologists treating difficult-to-manage tumor types

These physicians are the gatekeepers. They are the customers who must be convinced of the clinical benefit and manageable safety profile of the ICE® molecules. They treat the heavily pretreated, double-refractory patient populations. Their primary need is a drug that offers a superior objective response rate (ORR) and complete response (CR) rate with a better toxicity profile than salvage chemotherapy or existing immunotherapies.

For example, in R/R HL, the LuminICE-203 study with acimtamig (AFM13) showed an 86.4% ORR and 54.5% CR in a double-refractory population, which is a compelling data point for a hematologist looking for a new option. The ability to use the patient's own Natural Killer (NK) cells, or an off-the-shelf allogeneic NK cell product, offers a logistical and safety advantage over complex autologous CAR-T cell therapies, which is a major selling point for the prescribing physician.

Affimed N.V. (AFMD) - Canvas Business Model: Cost Structure

You're looking at Affimed N.V.'s cost structure, and the story is stark: it's a classic biotech narrative where massive investment in development eventually collides with a funding cliff. The entire cost model was geared toward high-stakes clinical trials, but the high cash burn rate ultimately led to the insolvency filing in May 2025.

The core of Affimed N.V.'s spending was its commitment to Research and Development (R&D), which is typical for a clinical-stage immuno-oncology company. Still, even with aggressive cost-cutting, the burn rate proved unsustainable, forcing the company to file for insolvency proceedings on May 13, 2025, with the local court in Mannheim, Germany.

Heavy Focus on Research and Development (R&D) Expenses

R&D expenses are the lifeblood of a biotech firm, representing the cost of developing proprietary innate cell engagers (ICE®) through the ROCK® platform. However, Affimed N.V. was already in an intense cost-reduction phase leading up to 2025. For the quarter ended September 30, 2024 (Q3 2024), R&D expenses were significantly reduced to €10.1 million, a sharp drop from €21.5 million in the same period in 2023.

This reduction wasn't a sign of financial health; it was a clear signal of retrenchment-a necessary move to stretch the cash runway. Here's the quick math on where the cuts hit:

• Lower procurement of clinical trial material.
• Reduced clinical trial and manufacturing costs for programs like acimtamig and AFM24.
• Decrease in headcount due to a corporate restructuring.

When R&D costs drop that fast, it means the pipeline's momentum is slowing. That's a huge risk for a clinical-stage company.

General and Administrative (G&A) Overhead (Q3 2024 was €4.3 million)

General and administrative (G&A) expenses, which cover things like executive salaries, legal, finance, and office costs, also saw a reduction, though they are a smaller part of the overall cost structure compared to R&D. In Q3 2024, G&A expenses were €4.3 million, down from €5.4 million in Q3 2023. This shows management was trying to control overhead, but it wasn't enough to offset the capital demands of their core business.

To give you a clearer picture of the primary cost components right before the financial crisis, here are the Q3 2024 figures:

Cost Category	Q3 2024 Expense (in millions)	Q3 2023 Expense (in millions)	Change (Year-over-Year)
Research & Development (R&D)	€10.1 million	€21.5 million	-53%
General & Administrative (G&A)	€4.3 million	€5.4 million	-20%
Total Operating Expenses (approx.)	€14.4 million	€26.9 million	-46.5%

High Cash Burn Rate, Leading to the May 2025 Insolvency Filing

Despite the aggressive cost-cutting-nearly halving total operating expenses year-over-year-the company's cash burn rate remained too high, and the revenue stream was minimal. Net cash used in operating activities for Q3 2024 was still €11.1 million. What this estimate hides is the need for massive, continuous capital raises to fund multi-year clinical trials, which they could defintely not secure.

The company reported a cash position of €24.1 million as of September 30, 2024, with a projected cash runway into the fourth quarter of 2025. However, the failure to secure additional capital led to the filing just five months later, on May 13, 2025.

The management determined the company was overindebted (Überschuldung) and lacked sufficient capital to continue operations. This is the final, concrete cost: the cost of a failed fundraising effort, which resulted in the suspension and eventual delisting of Affimed N.V.'s shares from The Nasdaq Global Market.

Affimed N.V. (AFMD) - Canvas Business Model: Revenue Streams

You're looking at Affimed N.V.'s revenue streams, and the direct takeaway is this: their income is defintely not from product sales, but from highly volatile, non-recurring collaboration payments. The entire revenue model hinges on hitting clinical and regulatory milestones with partners like Genentech and Roivant Sciences, a structure that carries immense near-term risk given the company's recent financial distress.

Collaboration and Licensing Revenue (Upfront and Milestone Payments)

As a clinical-stage biopharmaceutical company, Affimed N.V.'s primary revenue source is not commercial product sales but a series of collaboration and licensing agreements. This structure provides crucial, non-dilutive funding to advance their proprietary innate cell engager (ICE®) platform and product candidates like AFM13 and AFM24.

This revenue is recognized over time as performance obligations are met, or as lump-sum payments upon signing or achieving specific milestones. For example, the strategic collaboration with Roivant Sciences, signed in 2020, provided an initial $60 million in upfront consideration, composed of $40 million in cash and pre-paid R&D funding, plus $20 million in Roivant shares. That's a massive injection, but it's a one-time event. You can see the revenue drop-off once those initial services or milestones are completed.

Here's the quick math on how volatile this revenue can be, based on the latest reported figures:

Period	Total Revenue (in Euros)	Primary Source
Q3 2024	€0.2 million	Genentech platform license
Q3 2023	€2.0 million	Roivant research collaborations
Q1 2024	€0.2 million	Genentech platform license
Q1 2023	€4.5 million	Roivant and Genentech research collaborations

Potential Future Royalties on Commercialized Partnered Products

The long-term opportunity-the real jackpot-lies in future royalties, but that's years away and highly conditional. Affimed N.V. is eligible to receive significant payments tied to the successful development and commercialization of partnered assets.

The Roivant Sciences agreement, for instance, includes eligibility for up to an additional $2 billion in future development, regulatory, and commercial milestones, plus tiered royalties on net sales of any commercialized products. To be fair, that $2 billion figure is the ceiling for a best-case scenario across all programs, not a guarantee. These are the future revenue streams that justify the current R&D burn rate, but they are also the most speculative.

The key financial components of these potential future streams are:

• Tiered Royalties: Undisclosed percentages on net sales of licensed products, a standard biotech model.
• Development Milestones: Payments triggered by advancing a drug candidate into new clinical phases (e.g., Phase 3).
• Regulatory Milestones: Payments upon achieving key approvals (e.g., FDA approval).
• Commercial Milestones: Payments based on reaching specific annual sales targets.

Q3 2024 Total Revenue was Only €0.2 Million, a Sharp Decline

The recent financial results show just how precarious this model is. Total revenue for the quarter ended September 30, 2024, was a mere €0.2 million. This is a sharp decline from the €2.0 million reported in the same quarter of 2023. The reason for the drop is simple: the revenue in Q3 2024 was primarily from a platform license with Genentech, while the prior year included more substantial contributions from the now-completed Roivant research collaborations.

Revenue is Defintely Volatile, Tied to Collaboration Progress, Not Product Sales

The core reality here is that Affimed N.V.'s revenue is an accounting exercise in recognizing collaboration and license fees, not a sustainable commercial stream. It's a classic clinical-stage biotech profile. Revenue spikes when a collaboration is signed or a major milestone is hit, and it drops off sharply once the associated services are completed or the payment is received. This is why the Q1 2024 revenue was also only €0.2 million. What this estimate hides is the critical context of the 2025 fiscal year: the company announced in May 2025 that it had filed for the opening of insolvency proceedings, which fundamentally jeopardizes the continuation of these revenue-generating collaborations and the realization of any future milestones or royalties. The near-term cash runway was projected only into Q4 2025, underscoring the urgency of securing new funding or a major partnership event to sustain operations and, thus, the revenue stream itself. The entire business model is a high-stakes bet on clinical success and continued partnership funding.