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

En el paisaje en rápida evolución de la inmunoterapia contra el cáncer, Affimed N.V. (AFMD) emerge como una compañía de biotecnología pionera que revoluciona las estrategias de tratamiento a través de su innovador enfoque basado en células NK. Al aprovechar una plataforma de anticuerpos tetravalente sofisticada, esta empresa innovadora está redefiniendo cómo conceptualizamos las terapias de cáncer específicas, ofreciendo un potencial sin precedentes para intervenciones más precisas y efectivas que podrían transformar drásticamente los resultados de los pacientes. Su modelo de negocio único representa una fusión estratégica de investigación científica de vanguardia, asociaciones colaborativas y tecnologías inmunológicas transformadoras que prometen impulsar los límites del tratamiento oncológico.

Affimed N.V. (AFMD) - Modelo de negocio: asociaciones clave

Colaboraciones estratégicas con compañías farmacéuticas para ensayos clínicos

Affimed ha establecido asociaciones clave con las siguientes compañías farmacéuticas para ensayos clínicos:

Empresa asociada	Enfoque de asociación	Año establecido
Genentech	Desarrollo clínico AFM13 en linfomas positivos para CD30	2018
Merck	Ensayos de terapia combinada AFM24	2021

Asociaciones de investigación con instituciones académicas y médicas

Affimed mantiene relaciones de investigación colaborativa con:

• Centro de cáncer de MD Anderson
• Universidad de Heidelberg
• Centro de Investigación de Cáncer alemán (DKFZ)

Acuerdos de licencia para tecnologías de inmunoterapia con cáncer

Affimed ha asegurado los siguientes acuerdos de licencia:

Tecnología	Licenciante	Valor de acuerdo
Plataforma NK Cell Engager	Desarrollo interno	$ 0 (tecnología patentada)
Tecnología de inhibidores de la roca	Socio académico no revelado	Términos confidenciales

Organizaciones de fabricación de contratos para el desarrollo de medicamentos

Affimed colabora con organizaciones de fabricación de contratos especializadas:

• Grupo Lonza AG
• Biológicos de Samsung
• Wuxi Biologics

Posibles asociaciones de desarrollo de co-desarrollo en investigación oncológica

Las asociaciones posibles de desarrollo de co-desarrollo actuales incluyen:

Socio potencial	Área de investigación	Etapa de discusión
Bristol Myers Squibb	Terapias innatas de enganche de células innatas	Discusiones preliminares
Novartis	Tecnologías de orientación de células NK	Fase exploratoria

Affimed N.V. (AFMD) - Modelo de negocio: actividades clave

Desarrollar inmunoterapias innovadoras en cáncer basadas en células NK

Affimed se enfoca en desarrollar inmunoterapias contra el cáncer basadas en células NK dirigidas a tipos de cáncer específicos. A partir del cuarto trimestre de 2023, la compañía tiene:

• 3 programas terapéuticos basados ​​en células NK primares en desarrollo
• AFM13 como candidato terapéutico principal de NK Cell Engager
• Ensayos clínicos en curso en múltiples indicaciones de cáncer

Realización de investigaciones preclínicas y clínicas

Investigación de inversión y métricas de desarrollo clínico:

Categoría de investigación	2023 inversión	Pruebas activas
Investigación preclínica	$ 12.4 millones	4 programas
Ensayos clínicos	$ 24.7 millones	3 pruebas en curso

Diseño y prueba de anticuerpos terapéuticos dirigidos

Capacidades de diseño de anticuerpos:

• Plataforma de ingeniería de anticuerpos tetravalentes de forma patentada
• 7 Candidatos de anticuerpos terapéuticos únicos en la tubería
• Centrarse en tumores sólidos y neoplasias hematológicas

Avance de la plataforma de anticuerpos tetravalentes patentados

Métricas de desarrollo de la plataforma:

Métrica de plataforma	Estado 2023
Inversiones totales de plataforma	$ 18.3 millones
Nuevos diseños de anticuerpos	3 candidatos novedosos
Solicitudes de patentes	5 nuevas presentaciones

Persiguiendo aprobaciones regulatorias para candidatos a tratamiento del cáncer

Progreso regulatorio:

• AFM13 en etapas de ensayos clínicos avanzados para linfomas CD30+
• Interacciones regulatorias en curso de la FDA y EMA
• 2 solicitudes de nueva droga de investigación (IND) presentadas

Affimed N.V. (AFMD) - Modelo de negocio: recursos clave

Plataforma de ingeniería de anticuerpos tetravalente (biespecífica) patentado

La plataforma NKP46XCD16A Bispecífica NK de Affimed representa un recurso tecnológico crítico. A partir del cuarto trimestre de 2023, la compañía ha desarrollado múltiples candidatos en etapa clínica utilizando esta plataforma.

Característica de la plataforma	Detalles específicos
Tipo de tecnología	Ingeniería de anticuerpos biespecíficos de Tetravalent
Candidatos en etapa clínica	4-5 programas de desarrollo activo
Protección de patentes	Múltiples familias internacionales de patentes

Talento especializado científico y de investigación

El capital humano de Affimed representa un recurso clave significativo.

• Total de empleados al 31 de diciembre de 2023: 197
• Investigadores a nivel de doctorado: aproximadamente el 45% de la fuerza laboral
• Personal de investigación y desarrollo: 112 empleados

Cartera de propiedades intelectuales en inmunoterapia contra el cáncer

Categoría de IP	Métricas cuantitativas
Familias de patentes totales	25-30 familias de patentes activas
Cobertura geográfica	Estados Unidos, Europa, Japón
Rango de vencimiento de patentes	2030-2040

Instalaciones avanzadas de laboratorio e investigación

Affimed mantiene una sofisticada infraestructura de investigación.

• Ubicación de la investigación principal: Heidelberg, Alemania
• Espacio total de la instalación de investigación: aproximadamente 15,000 metros cuadrados
• Laboratorios avanzados de cultivo celular y biología molecular: 6 laboratorios especializados

Datos de ensayos clínicos e información de investigación

Métrico de ensayo clínico	Estado actual
Ensayos clínicos activos	5-6 pruebas en curso
Total de los pacientes inscritos	Aproximadamente 250-300 pacientes
Publicaciones de investigación	35-40 Publicaciones revisadas por pares

Affimed N.V. (AFMD) - Modelo de negocio: propuestas de valor

Soluciones innovadoras de inmunoterapia con cáncer dirigido

Affimed N.V. se centra en desarrollar anticuerpos tetravalentes e innatos de compromiso celular dirigido a tipos de cáncer específicos.

Plataforma terapéutica	Características clave	Etapa de desarrollo
AFM13	Engager de células NK para linfomas CD30+	Ensayos clínicos de fase 2
AFM24	Engager de células NK para tumores que expresan EGFR	Ensayos clínicos de fase 1/2
AFM26	Engager de celda NK dirigido a CD123	Desarrollo preclínico

Potencial para tratamientos contra el cáncer más efectivos y precisos

La tecnología NKCE patentada de Affimed permite la activación del sistema inmunitario dirigido con posibles ventajas:

• Especificidad mejorada en la orientación tumoral
• Toxicidad sistémica reducida
• Índice terapéutico mejorado

Enfoque terapéutico de compromiso de células NK avanzada

Tecnología	Mecanismo	Ventaja única
Plataforma NKCE	Redirección de células asesinas naturales	Eliminación precisa de las células tumorales

Inmunoterapia personalizada dirigida a tipos de cáncer específicos

Los candidatos terapéuticos de Affimed se dirigen a múltiples indicaciones de cáncer:

• Linfoma de Hodgkin
• Linfoma no hodgkin
• Tumores sólidos
• Leucemia mieloide aguda

Mejores resultados del paciente a través de nuevos mecanismos terapéuticos

Programa clínico	Población objetivo	Impacto potencial
AFM13	Linfomas recidivantes/refractarios CD30+	Opción de tratamiento alternativo
AFM24	Tumores sólidos que expresan EGFR	Terapia potencial de avance

Affimed N.V. (AFMD) - Modelo de negocio: relaciones con los clientes

Comunidad directa de compromiso con la investigación de oncología

A partir del cuarto trimestre de 2023, Affimed mantuvo relaciones directas con 127 instituciones de investigación de oncología a nivel mundial. Su estrategia de compromiso involucrada:

• Seminarios web científicos mensuales
• Programas de colaboración de investigación específicas
• Canales de comunicación de ensayos clínicos directos

Tipo de compromiso	Número de interacciones	Duración promedio
Investigar seminarios web	42 por año	90 minutos
Asociaciones de investigación directa	17 colaboraciones activas	En curso

Asociaciones colaborativas con compañías farmacéuticas

En 2023, affimed mantuvo asociaciones estratégicas con 6 compañías farmacéuticas, incluidas Merck y Genentech.

Pareja	Enfoque de colaboración	Valor de contrato
Merck	Desarrollo de terapia con células NK	$ 45 millones
Genentech	Investigación de inmunoterapia	$ 38.5 millones

Comunicación transparente sobre el progreso del ensayo clínico

Affimed publicó 23 actualizaciones detalladas de ensayos clínicos en 2023, cubriendo:

• Estado de reclutamiento de pacientes
• Datos de seguridad provisionales
• Resultados de eficacia preliminares

Programas de apoyo y educación del paciente

Métricas de participación del paciente para 2023:

Tipo de programa	Participantes totales	Alcance digital
Sesiones de información en línea	1.247 pacientes	82,500 vistas digitales
Webinarios web de apoyo al paciente	876 participantes	45,300 vistas digitales

Conferencia científica y participación del simposio médico

Compromiso de la conferencia en 2023:

Tipo de conferencia	Número de conferencias	Presentaciones entregadas
Conferencias internacionales de oncología	12	37
Simposios de inmunoterapia	8	22

Affimed N.V. (AFMD) - Modelo de negocio: canales

Equipo de ventas directas para asociaciones farmacéuticas

A partir del cuarto trimestre de 2023, Affimed mantuvo un equipo de ventas especializado de 12 profesionales dirigidos a canales de colaboración farmacéutica.

Canal de ventas	Número de asociaciones activas	Alcance del mercado objetivo
Ventas directas farmacéuticas	4 asociaciones estratégicas	América del Norte y Europa
Colaboración enfocada en oncología	3 asociaciones de investigación en curso	Mercado global de inmunoterapia

Publicaciones científicas y presentaciones de investigación

En 2023, Affimed presentó investigación en 7 conferencias científicas internacionales.

• Reunión anual de la Asociación Americana de Investigación del Cáncer (AACR)
• Congreso de la Sociedad Europea de Oncología Médica (ESMO)
• Reunión anual de la Sociedad para la Inmunoterapia del Cáncer (SITC)

Comunicaciones de relaciones con los inversores

Las comunicaciones trimestrales de los inversores incluyeron:

• 4 llamadas de conferencia de ganancias
• 2 presentaciones del día de los inversores
• Informe anual completo

Marketing digital y plataformas científicas en línea

Canal digital	Métricas de compromiso	Alcanzar
LinkedIn	12,500 seguidores	Biotecnología y profesionales farmacéuticos
Sitio web científico	35,000 visitantes únicos mensuales	Comunidad de Investigación Global

Exposiciones de conferencias médicas y redes

2023 Estadísticas de participación de la conferencia:

• 8 conferencias médicas internacionales asistidas
• 15 presentaciones de póster de investigación
• Redes con más de 250 colaboradores de investigación potenciales

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

Instituciones de investigación de oncología

Objetivos afligidos La liderante de investigación de oncología con un enfoque específico en la investigación de inmunoterapia.

Tipo de institución	Valor de colaboración de investigación potencial	Tasa de compromiso anual
Centros de investigación académicos	$ 2.4 millones por colaboración	Tasa de compromiso del 67%
Institutos Nacionales de Cáncer	$ 3.1 millones por asociación	Tasa de participación del 54%

Compañías farmacéuticas

Los socios farmacéuticos representan segmentos críticos de clientes para el desarrollo terapéutico de Affimed.

• Los socios farmacéuticos de primer nivel incluyen Genentech, Merck, Janssen
• La valoración potencial de la asociación varía de $ 50-250 millones
• Colaboraciones farmacéuticas activas activas: 3

Centros de tratamiento del cáncer

Los centros de tratamiento de cáncer especializados representan un segmento clave de clientes para ensayos clínicos y adopción terapéutica.

Tipo central	Número de centros potenciales	Participación anual del ensayo clínico
Centros de cáncer integrales	51 centros	38 compromisos de prueba activos
Centros de oncología comunitaria	1.200 centros	22 compromisos de prueba activos

Investigadores clínicos

Los investigadores clínicos representan un segmento crucial de clientes para avanzar en la investigación de inmunoterapia.

• Población de investigadores objetivo: 8.500 especialistas en oncología
• Potencial de subvención de investigación anual: $ 4.2 millones
• Colaboraciones actuales de investigadores activos: 27

Pacientes potenciales con tipos de cáncer dirigidos

Los segmentos de los pacientes se centran en indicaciones específicas de cáncer compatibles con el enfoque terapéutico de Affimed.

Tipo de cáncer	Potencial de población de pacientes	Tamaño del mercado objetivo
Linfoma no hodgkin	87,000 casos nuevos anualmente	Mercado potencial de $ 340 millones
Mieloma múltiple	34,500 casos nuevos anualmente	Mercado potencial de $ 275 millones

Affimed N.V. (AFMD) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Affimed N.V. reportó gastos totales de I + D de $ 75.4 millones.

Año	Gastos de I + D	Porcentaje de costos operativos totales
2022	$ 68.2 millones	62.5%
2023	$ 75.4 millones	65.3%

Costos de gestión de ensayos clínicos

Los gastos de ensayo clínico para affimed en 2023 totalizaron aproximadamente $ 42.6 millones.

• Pruebas de fase I: $ 12.3 millones
• Ensayos de fase II: $ 18.5 millones
• Pruebas de fase III: $ 11.8 millones

Mantenimiento de la propiedad intelectual

Costos anuales de propiedad intelectual y mantenimiento de patentes: $ 3.2 millones.

Personal y compensación de talento científico

Categoría de personal	Compensación anual
Científicos de investigación senior	$185,000 - $245,000
Gerentes de investigación clínica	$145,000 - $195,000
Gastos totales de personal	$ 28.7 millones

Inversiones en tecnología e infraestructura de laboratorio

Inversión en tecnología e infraestructura para 2023: $ 15.6 millones.

• Equipo de laboratorio: $ 8.3 millones
• Infraestructura computacional: $ 4.2 millones
• Software y plataformas de investigación: $ 3.1 millones

Affimed N.V. (AFMD) - Modelo de negocios: flujos de ingresos

Pagos potenciales de hitos de los acuerdos de asociación

A partir de 2024, Affimed N.V. tiene acuerdos de asociación con varias compañías farmacéuticas que generan posibles pagos de hitos:

Pareja	Pago potencial de hito	Programa
Genentech	Hasta $ 750 millones	Programa AFM24
Merck	Hasta $ 1.24 mil millones	Plataforma de Innate Cell Engager

Ingresos futuros de licencia de tecnologías terapéuticas

Las posibles flujos de ingresos de licencias de Affimed incluyen:

• Licencias de plataforma Innate Cell Engager (ICE)
• Licencias de tecnología terapéutica AFM13
• Licencias de tecnología terapéutica AFM24

Contratos de colaboración de desarrollo de fármacos

Contratos de colaboración actuales con implicaciones financieras:

Colaborador	Valor de contrato	Enfoque de investigación
Merck	$ 96 millones de pago por adelantado	Inmunoterapia con cáncer

Posibles regalías de terapias aprobadas

Rangos de regalías potenciales para candidatos terapéuticos:

• AFM13: tasa de regalías potencial 8-12%
• AFM24: 10-15% tasa de regalías potencial

Subvimiento de financiación y apoyo de investigación

Fuentes de financiación de investigación para 2024:

Fuente de financiación	Cantidad	Área de investigación
NIH Subvenciones	$ 2.3 millones	Investigación oncológica
Consejo de Investigación Europea	$ 1.7 millones	Desarrollo de inmunoterapia

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.